cyrilzakka/clinical-trials huggingface dataset:
Dimensional Changes of Peri-implant Tissue in Immediate Implants With Individualized Healing Abutments

The loss of a tooth leads to a series of biological changes in the tissues, resulting in bone resorption and gingival collapse. To avoid these problems, it has been proposed to place immediate post-extraction implants, allowing a reduction in treatment time and the number of surgeries, as well as better maintenance of the tissues. This technique can be performed with standard abutments after implant placement or, more recently, the use of temporary abutments has been proposed.

Objective: To check if custom healing abutments manufactured using CAD/CAM technique in immediate implants promote greater dimensional stability of the peri-implant tissue compared to standard healing abutments.

Methods: After the extraction, an immediate Klockner Vega+ implant will be placed and the gap will be filled with a bone substitute (Cerabone, Botiss). The patient will then be randomized to the control group (standard healing abutment) or the test group (custom healing abutment using CAD/CAM technique). In the latter case, a peripheral seal is achieved, allowing for wound closure and stabilization of the clot with the same shape as the crown in its transmucosal part.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient ( 25 years old).
* Need for extraction of an irrational tooth to be treated in the molar/premolar position of the upper/lower arch.
* Presence of 2mm of keratinized gingiva.
* Bone dehiscence in the alveolar walls of 2 mm. 2 mm.
* Adequate amount of bone in the interradicular septum to stabilize the implant (minimum height 10 mm, minimum width 4 mm at the base of the septum).
* Plaque index (FMSPI, full mouth score plaque index) \< 10%.
* Non-smokers or smokers of less than 10 cigarettes per day.
* Absence of systemic diseases that contraindicate implant surgery.

Exclusion Criteria:

* Presence of alveoli with dehiscence \>2mm.
* Presence of adjacent implants.
* \< 2mm of keratinized gingiva.
* Presence of active infection (fistula, suppuration) at the extraction site.
* Presence of apical granuloma \>2mm in diameter in the root(s) of the tooth or teeth to be extracted.
* Residual bone apical to the extraction insufficient to anchor the implant.
* Pregnant or lactating women.
* Severe cognitive or psychiatric disorders.
* Compromised general health status ( ASA IV).
* Use of drugs that alter bone metabolism and healing.
* Absence of manual primary stability of the implant
* Bone dehiscence or fenestration after implant placement (manual rotation).
* Gap 2mm between the implant and the vestibular bone wall.
Confocal Laser Endomicroscopy, IBS and Stress

After standard endomicroscopy with fluorescein to investigate for dysplasia in Barrett's esophagus the endoscope will be forwarded into the 2nd part of the duodenum. Fluorescein is needed for CLE but is not part of the investigation.

Initial CLE baseline images will be taken to assure intact mucosa and allow later detailed baseline counts of intraepithelial lymphocytes (IEL) and epithelial breaks in the duodenal mucosa.

Thereafter, either 10 ml NaCl 0.9% or 100µg CRF topped up to 10ml with NaCL 0.9% (according to randomisation) will be injected intravenously. Endoscopist and assistant staff will be blinded to the randomisation. Subsequently, the gut surface will be examined for at least 5 min with endomicroscopy for any change in IEL, epithelial breaks/gaps with extrusion of fluorescein into the gut lumen and widening of intervillous space.

Post procedure mucosal fluid will be aspirated for assessment of mast cell tryptase and eosin catatonic protein (ECP), and 8 duodenal biopsies will be taken for 1) electron microscopy to visualise mast cell degranulation and 2) paraffin embedding for subsequent staining for mast cell tryptase to identify mast cell activation and numbers.

The procedure will take around 15 minutes in addition to the routine investigation performed prior to the study. A study outline is presented in figure 1.

Samples taken are the same amount as done in the previous food associated study.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* No abdominal symptoms such as bloating and abdominal pain
* Barrett's esophagus
* Independent indication for confocal laser endomicroscopy for evaluation of Barrett's dysplasia
* Written informed consent for participation in this study

Exclusion Criteria:

* Any known other gastrointestinal disease including infection such as helicobacter pylori, Morbus Whipple or others, celiac disease, or chronic inflammatory bowel disease
* Active or recent GI Bleeding
* Stricture in the upper gastrointestinal tract
* Impaired renal function (Creatinine \>1.2 mg/dL)
* Pregnancy or breast feeding
* Inability to obtain informed consent
* Known allergy to Methylene blue or Fluorescein
* Participation in other clinical trials within the last 4 weeks
TMVP1-ICG Mapping in Laparoscopic SLN Detection in Cervical Cancer

Sentinel lymph node (SLN) mapping is an acceptable surgical strategy determine whether to perform radical lymphadenectomy in patients with early-stage cervical cancer. Investigators aim to determine the validity of this technique with our novel tumor targeted fluorescent TMVP1-ICG to increased accuracy of SLN mapping.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age, married, without childbearing requirements at the time of consent.
* FIGO stage IA1-IIB cervical squamous cell cancer and is a candidate for laparoscopy intervention, with lymph node dissection being a part of the surgical plan.
* Subject has provided written informed consent.

Exclusion Criteria:

* Breast-feeding or pregnant
* Ongoing participation in another clinical trial with an investigational drug with 3 months
* Own allergy towards ICG and/or alcohol
* Diagnosis of bacterial vaginosis, fungal vaginitis, sexually transmitted diseases
* Patients with cardiac dysfunction or hepatic insufficiency or renal insufficiency
Evaluate the Safety and Effectiveness of Steerable Ureteroscopic Renal Evacuation (SURE) Using the CVAC® System

The purpose of the study is to assess safety and efficacy of a novel steerable ureteral catheter system, the CVAC System for the treatment of urinary stones.


Eligibility Criteria:
Inclusion Criteria:

* Candidate for ureteroscopy with laser lithotripsy;
* Be willing and able to return for and respond to all study-related follow up procedures; and,
* Have been informed of the nature of the study and have agreed to the IRB approved informed consent form (ICF).

Exclusion Criteria:

* Significant morbidities;
* Unable to meet the treatment and follow up protocol requirements; and,
* Ureteral or kidney abnormalities.
The Effects of Breathing Retraining in Patients With Interstitial Lung Diseases

Breathing retraining has been reported to lead to improvements in dyspnoea and walking distance in chronic obstructive pulmonary disease (COPD) patients. Evidence regarding the effects of such an intervention in ILD patients is though lacking. In view of this, the aims of such a study were to identify whether breathing retraining led to better management of dyspnoea and improved walking distance in ILD patients.

One of the commonest symptoms experienced in patients with a diagnosis of interstitial lung disease (ILD) is shortness of breath, a symptom which greatly affects their abilities to carry out activities of daily living. Breathing retraining has been reported to lead to improvements in dyspnoea and walking distance in chronic obstructive pulmonary disease (COPD) patients. Evidence regarding the effects of such an intervention in ILD patients is though lacking. In view of this, the aims of such a study were to identify whether breathing retraining led to better management of dyspnoea and improved walking distance in ILD patients. Twenty Seven ILD patients were randomly distributed to either the control group (n=15) which received a 12-week Pulmonary Rehabilitation (PR) programme without breathing retraining or the active group (n=12) which received a 12-week PR programme with breathing retraining. All patients had both the 6-minute walk test and their level of breathlessness assessed using the Dyspnoea Borg scale assessed at baseline and at 4 weekly intervals for a 12-week period throughout the programme.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed diagnosis of ILD and who were referred for PR

Exclusion Criteria:

* Patients who had musculoskeletal or neurological conditions affecting the outcome measures
* Patients who required oxygen therapy and did not accept administration
* Patients with unstable cardiovascular conditions
* Patients who were not willing to participate
A Study of JNJ-88549968 for the Treatment of Calreticulin (CALR)-Mutated Myeloproliferative Neoplasms

The purpose of this study is to characterize safety and to determine the Recommended Phase 2 Dose (RP2D\[s\]) and optimal dosing schedule(s) of JNJ-88549968, in part 1 (Dose Escalation); to characterize the safety of JNJ- 88549968 at RP2D(s), in part 2 (Cohort Expansion).


Eligibility Criteria:
Inclusion Criteria:

* Be greater than or equal to (\>=) 18 years of age (or the legal age of majority in the jurisdiction in which the study is taking place, whichever the greater) at the time of informed consent
* Positive for a calreticulin (CALR) driver mutation of essential thrombocythemia (ET) or myelofibrosis (MF)
* Participants with ET and MF with risk characteristics as described in the protocol
* Have an Eastern Cooperative Oncology Group (ECOG) performance status grade of less than or equal to (\<=) 2

Exclusion Criteria:

* Known allergies, hypersensitivity, or intolerance to the excipients of the study treatment
* Concurrent or recently diagnosed or treated malignancies present at the time of participant screening. Exceptions are squamous and basal cell carcinoma of the skin, carcinoma in situ of the cervix, and any malignancy that is considered cured or has minimal risk of recurrence within 1 year of first dose of study treatment in the opinion of both the investigator and sponsor's medical monitor. Participants cured of another malignant disease with no sign of relapse greater than or equal to (\>=) 3 years after treatment ended are allowed to enter the study
* Prior solid organ transplantation
* Either of the following regarding hematopoietic stem cell transplantation:

  1. Prior treatment with allogenic stem cell transplant less than or equal to (\<=) 6 months before the first dose of JNJ-88549968 or
  2. Evidence of graft versus host disease (GVHD) that requires immunosuppressant therapy
* History of clinically significant cardiovascular disease within 6 months prior to the first dose of study treatment
Inhibition of Food Intake in Response to Oral GLP-1 and Peptide YY3-36

Interaction of GLP-1 and PYY3-36 in the inhibition of food intake in healthy subjects

PYY3-36 and GLP-1 are two classical gastrointestinal peptides, which are released into the circulation during meals from L-cells of the distal gut; there is compelling evidence that each participates in the control of appetite regulating individual meal sizes in healthy subjects, but also in patients with obesity or diabetes type II. The regulation of human eating habits is, however, highly complex and our understanding of appetite control is far from complete. In many areas our knowledge is rather rudimentary; little is known, to give an example, about the importance of individual signals and their interactions.

From studies in animals and humans it is known that individual satiety signals can interact: contributions of glucagon and CCK produced functionally synergistic inhibitions of feeding in rats, that is, simultaneous injection of the two peptides inhibited feeding significantly more than the sum of their individual effects. In contrast, we have been unable to show in healthy volunteers any interaction between GLP-1 and CCK33; the simultaneous infusion of CCK33 and GLP-1 resulted in an infra-additive reduction in meal size, which led us to suggest that the two peptides could even interact antagonistically.

To further explore potential interactions between these two well-known satiety signals, we plan to investigate the effects of individual doses of PYY3-36 and GLP-1, and their interaction in the control of food intake and satiety in healthy male subjects.

Eligibility Criteria:
Inclusion Criteria:

* healthy male subjects
* no evidence of disease
* no history of gastrointestinal or endocrine disorders

Exclusion Criteria:

* alcohol and drug abuse
* history of gastrointestinal or endocrine disorders
* female subjects
Investigating the Effect of Carpal Tunnel Syndrome on Activity and Participation

The aim of our study was to examine the effect of different severities of Carpal Tunnel Syndrome on activity and participation within the framework of the International Classification of Functioning, Disability and Health (ICF).

Individuals between the ages of 18-65 who were diagnosed with CTS in the dominant hand and who volunteered to participate in the study were included. SF-36, Quick Disabilities of the Arm, Shoulder, and Hand (Q-DASH), Michigan Hand Outcomes Questionnaire and Boston Carpal Tunnel Questionnaire - Functional Status Scale will be used to assess activity and participation. The questionnaires will be filled out via Google Forms. Shapiro-Wilk test will be performed to determine the distribution of the data. Whether the dependent variables differ between groups will be analysed by One-way ANOVA (continuous). For significant F-test, an additional investigation of differences between groups will be performed with Gabriel's post hoc procedure.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CTS in the dominant hand
* Being between the ages of 18-65
* Volunteering to participate in the study

Exclusion Criteria:

* Having systemic inflammatory disease
* Having a disease that may cause polyneuropathy such as diabetes mellitus
* Having a pacemaker
* Having a disease affecting the central nervous system
* Having cervical radiculopathy
* History of previous operation or local steroid injection due to CTS
Study Assessing Double-masked Uveitis Treatment

The purpose of this study is to evaluate the safety and efficacy of intravitreal injections of DE-109 ophthalmic solution.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of active uveitis
* 18 years of age or older
* Sign informed consent
* Meet best corrected ETDRS visual acuity

Exclusion Criteria:

* Uveitis of infectious etiology
* Suspected/confirmed central nervous system or ocular lymphoma
* Primary diagnosis of anterior uveitis
* Uncontrolled glaucoma
* Use of topical oculary medication
* Implanted device
* Significant ocular disease
* Lens/media opacities or obscured ocular media
* Intraocular surgery or treatments
* Capsulotomy
* Ocular or periocular infection
* Pupillary dilation
* History of herpetic infection
* Toxoplasmosis or toxoplasmosis scar
* Ocular malignancy
* Allergy or hypersensitivity to study drug
* Participation in other uveitis trial within 30 days
* Monoclonal antibody treatment or biologic therapy
* Any systemic condition/infection
* Immunosuppressive therapy or immunocompromised
* Malignancy remission
* Females who are pregnant or lactating and females not using adequate contraceptives
Efficacy of Two Probiotic Preparations in Children With Acute Diarrhoea

The purpose of this study is to determine which of two different preparations of probiotics is effective in the treatment of acute viral diarrhoea in children.

Children and infants, aged 1 month to 5 years, with acute diarrhoea, will be randomised to receive either saccharomyces boulardii, a combination probiotic (Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus rhamnosus, Lactobacillus plantarum, Bifidobacterium infantis, Streptococcus thermophillus) or placebo, to determine if one shortens the duration of diarrhoea.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute viral gastroenteritis

Exclusion Criteria:

* Moderate or severe dehydration
* Malnutrition
* Immunodeficiencies
* Sepsis or bacterial infection
* Previous use of antibiotics, antidiarrheal drugs, or probiotics, in the last four weeks.
* Hospitalisation
* No phone number
* Illiteracy
Perioperative Medical Program to Optimize Nerve Regeneration After Robot-assisted Laparoscopic Neurolyses of Pudendal and/or Inferior Cluneal Nerves for Chronic Neuralgias: Results After 1-year Follow-up

Pudendal and inferior cluneal neuralgias are responsible for chronic pelvicperineal pain. These two neuralgias are associated in approximately 25% of cases. In the event of failure of first-line multimodal medical treatment, a mini-invasive robot-assisted laparoscopic decompression can be proposed. These surgeries carry the risk of neurapraxia, leading to a temporary increase in neuropathic pain and numbness in the nerve sensitive area, a motoric or neurovegetative disturbance (pudendal).


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old
* Patients presenting a pudendal and/or inferior cluneal neuralgias with failure of the medical treatment
* Patient having given consent after reading the information note

Exclusion Criteria:

* Inoperable patients (contraindications to anesthesia or surgery) surgical contraindications)
* Person deprived of liberty or under guardianship
* Person under court protection
* Pregnant or breast-feeding woman
* Minors
Safety and Tolerability Study in Patients With Mild to Moderate Alzheimer's Disease (AD)

This study will evaluate the safety and tolerability and Aß-specific antibody response of CAD106 in patients with mild to moderate Alzheimer's Disease.

Patients also had a 2 year follow-up to assess disease progression where no drug was administered.


Eligibility Criteria:
Inclusion Criteria:

* males and/or females patients between 50 to 80 years of age (both inclusive).
* female patients must be without childbearing potential (post-menopausal or surgically sterilized).
* diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria (Diagnostic and Statistical Manual of Mental Disorders, 4th edition).
* mild to moderate AD as confirmed by Mini-Mental State Exam score of 16 to 26 (both inclusive) at screening.
* able to provide written informed consent and having a responsible caregiver that can provide written assent prior to study participation. For patients who have been declared mentally incompetent, a legal representative will need to provide informed consent on their behalf.

Exclusion Criteria:

* previously participated in an AD vaccine study and received active treatment
* history or presence of an active autoimmune and/or cerebrovascular disease
* history or presence of seizures, with an acute or chronic inflammation
* clinically relevant atopic condition, who suffer from an other neurodegenerative disease and/or psychiatric disorders (with the exception of successfully treated depression)
* immunosuppressive treatment including systemic steroids
* obtained a vaccination (e.g. against influenza) within 4 weeks before the first study drug injection
* advanced, severe, progressive or unstable disease that might interfere with the safety of the patient
* started treatment with psychotropic medication within 3 months (4 weeks for SSRIs and other newer antidepressants without anticholinergic properties) prior to randomization with the exception of mild hypnotic drugs (e.g. zolpidem, zopiclone, oxazepam) and low doses of neuroleptic drugs (e.g. up to 2 mg risperidone).

Patients, who are on stable treatment with cholinesterase-inhibitors (ChEIs) and/or memantine for at least 3 months, and/or with SSRIs and/or other newer antidepressants (without anticholinergic properties) for at least 4 weeks before randomization, can be included into the study.
Digital Photographs to Evaluate Blepharoptosis

To compare measurements made by a computer software (ImageJ) made on photographs to the traditional clinical measures with a ruler in the evaluation of blepharoptosis


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years old or older
* Patients presenting for evaluation of blepharoptosis of any kind except the one mentioned in the exclusion criteria

Exclusion Criteria:

* Myasthenia gravis
* Thyroid eye disease
Are There Sleep-related Factors That Contribute to an Increased Incidence of Pre-eclampsia at Altitude?

Women at altitude have an increased incidence of pre-eclampsia. Populations at altitude have a greater incidence of sleep apnea. And women with sleep apnea are at increased risk of developing preeclampsia. This research project will recruit for home sleep testing: healthy pregnant women at altitude (Summit County , Colorado at 9000 ft.), and women with preeclampsia at altitude, in order to learn whether either sleep apnea or nocturnal hypoxemia is more common or more severe in women with preeclampsia, than in healthy women at altitude. In addition a healthy co-hort of pregnant women will be studied at sea level, to compare to the healthy cohort of pregnant woman in Summit County, to learn to degree that this difference in altitude effects the severity of sleep apnea and hypoxemia.

It is known that high altitude increases the risk of preeclampsia and small for gestational age births. Our questions are: 1). Is sleep apnea during pregnancy more common and/or more severe at altitude? And 2) Do the women who develop preeclampsia at altitude have more severe sleep apnea, or worse hypoxemia during sleep, than the women at altitude who do not develop preeclampsia. We will perform WatchPAT-one home sleep tests (PAT = peripheral arterial tonometry) on up to 20 pregnant women in Summit County Colorado (\>9000 ft.elevation) who develop preeclampsia during pregnancy (soon after diagnosis), and also on up to 20 pregnant healthy women in Summit County, and 20 healthy pregnant women in Baltimore (at sea level). These healthy pregnant women in Summit County and Baltimore will be selected from volunteer participants, to best match age, pre-pregnancy BMI, and race with individuals in Summit County who are studied with preeclampsia and they will be studied at the gestational timing that matches their Summit County preeclampsia matching subject. In addition to the up to 20 healthy pregnant subjects at Summit County and 20 in Baltimore, who match the preeclampsia subjects, we will recruit up to 20 more in Summit County and 20 more in Baltimore, to study specifically in the 33rd or 34th gestational week, to improve our ability to evaluate the effects of altitude on sleep apnea, during pregnancy. Information on the births, including height and weight and apgar scores will be assessed, in part to see whether sleep apnea during pregnancy affects outcomes. All sleep studies will be scored at the JHH (Johns Hopkins Hospital) Bayview sleep lab's Center for Interdisciplinary Sleep Research and Education.

Eligibility Criteria:
Inclusion Criteria: pregnant, age 18-35, possession of, or availablitiy of using a cell phone.

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Exclusion Criteria: for the control group the following are exclusion criteria: hypertension, known sleep apnea, asthma requiring daily inhaler use, other lung disease, diabetes

For the group who are recruited at the time of diagnosis of pre-eclampsia - hypertension is not an exclusion criteria.

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EEG and NIRS in Preterm Infants

Experimental cross-sectional study of a single application (vojta therapy or massage) in preterm and non-preterm infants to test whether there are differences in brain activation and oxygenation that occur with both techniques between term and preterm infants.

Secondly, the brain activation and oxygenation produced by both physiotherapy techniques will be tested separately to establish comparisons between the two groups.

Finally, between 3 - 6 months, we will analyse whether there are changes in gaze fixation (eye tracker) in the 4 study arms to see if there are differences between term and preterm infants but also the differences between the immediate effectiveness of both techniques.


Eligibility Criteria:
Inclusion Criteria:

* term and preterm babys
* first month after birth

Exclusion Criteria:

* intrumental delivery
* pathology associated