cyrilzakka/clinical-trials huggingface dataset:
Revaccination With PNEUMOVAX™ 23 in Older Japanese Adults (V110-902)

The purpose of this study is to determine if revaccination with pneumococcal vaccine (PNEUMOVAX™ 23, V110) is well tolerated and produces an immune response in older Japanese adults. The primary hypothesis being tested is that the geometric mean concentration of antibodies to pneumococcal polysaccharide serotypes 3, 6B, and 23F at 4 weeks after revaccination will be superior to that before revaccination in Japanese adults who received a primary vaccination at least 5 years before revaccination.


Eligibility Criteria:
Inclusion Criteria:

* Japanese participant
* Good health or any underlying chronic illness is documented to be in stable condition
* Revaccination Group: received one documented PNEUMOVAX™ 23 vaccination at least 5 years before enrollment in the study
* Primary Vaccination Group: no prior history with PNEUMOVAX™ 23 vaccination Exclusion Criteria:
* Known allergy or sensitivity to any of the components of the study vaccine
* History of pneumococcal conjugate vaccination
* Known or suspected immune dysfunction, immunosuppression, or autoimmune disease. Participants with a history of cancer who are not actively treated and not immunosuppressed will be eligible
* Functional or anatomic asplenia
* Received immunoglobulin within 6 months before study vaccine or is planned during the study
* Received any investigational drugs or vaccines within 2 months before study vaccination
* History of pneumococcal disease (positive culture from blood or other normally sterile site)
* Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
* History of convulsion
* Previously diagnosed with immunodeficiency or has a close relative with congenital immune deficiency
* Participating in any other clinical trial
Effect of Supplementation With HMB and Glutamine in Wound Healing on Bloody Areas

A randomized controlled clinical trial in two groups of supplementation with HMB and glutamine. Each group consist in 25 patients with bloody areas, one group will receive and intervention with HMB and Glutamine and the other will receive a placebo with calcium caseinate.

A fundamental part of the integral management of wound healing in patients with bloody areas is nutrition, since it involves biochemical events that depend on the substrates it provides. Wound healing is a phase that demands higher needs of energy-protein than the requirement. Problem statement: Poor nutrition decreases, through specific phases, normal processes that allow the progression of wound healing. Nutrient deficiencies can have negative effects on wound healing by prolonging the inflammatory phase, decreasing fibroblast proliferation, and modifying collagen synthesis. Some amino acids are essential for the process, such as Glutamine and Hydroxymethylbutyrate.

Objective: To evaluate the effect of Glutamine and Hydroxymethylbutyrate supplementation over the cells involved in wound healing of bloody areas. Hypothesis: Glutamine and Hydroxymethylbutyrate supplementation promotes a positive effect over the cells involved in wound healing of bloody areas. Methodology: A randomized controlled clinical trial, in patients with diagnosis of bloody areas. They will be divided into two groups, the first will receive an intervention with Glutamine (14g) and Hydroxymethylbutyrate (3g) and a control group will receive a placebo with calcium caseinate (17g)

A sample of the affected tissue will be taken before and after the supplementation where histology will be analyzed.

Remains of tissue will be obteined during surgery wash for histology.

Eligibility Criteria:
Inclusion Criteria:

* Patients with bloody areas at hospital admission
* Hospital length stay around 15 days
* Medical treatment with surgical washing and negative pressure systems
* For the groups with diabetes, patients with diagnosis of type 2 diabetes with bloody areas.
* Patients that accepts and signs the informative consent.

Exclusion Criteria:

* patients with cancer or immunodeficiency
* patients with HbA1c \< 12
* patients with collagen disease
* patients with allergy to intervention substances (HMB, glutamine)
The Relationship Between Age and Carpal Tunnel Size

Investigators hypothesis is that as human age increases, the size of the carpal tunnel decreases.

Participants will be taken to a hand examination room where a portable ultrasound (US) machine is present. A previously determined wrist will be examined for each of the participants. The US will be used to obtain measurements of the subjects carpal tunnel and median nerve at multiple levels in order to define its size.

Eligibility Criteria:
Inclusion Criteria:

* Greater than age 18 having bilateral wrists amenable to ultrasound examination.

Exclusion Criteria:

* Active carpal tunnel syndrome,
* history of carpal tunnel syndrome
* any prior arm or hand surgery (including previous carpal tunnel release for any reason or previous surgery on the volar wrist)
* distal radius fracture deformity
* rheumatoid arthritis
* open wounds or lesions of the hand or forearm
* known congenital deformities of the upper extremity.
An Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta

The purpose of this study is to investigate the effect of BPS804 on strength/quality of bone in patients with Type I, III or IV Osteogenesis imperfecta using a special type of CT scanner. Participants will be treated for 1 year.

This study was previously posted by Mereo Biopharma and was transferred to Ultragenyx in February 2021.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical diagnosis of OI Type I, III or IV
* Capable of giving signed consent

Exclusion Criteria:

* History of skeletal malignancies or other bone diseases (other than OI)
* History of endocrine or thyroid/parathyroid conditions that could affect bone metabolism
* Treatment with bisphosphonates within 3 months of randomisation
* Treatment with teraparatide, denosomab or other anabolic/antiresorbative medications within 6 months of randomisation
Personalized Pacing: A New Paradigm for Patients With Diastolic Dysfunction or Heart Failure With Preserved Ejection Fraction

Recent exploratory studies suggest that pacemaker patients with diastolic dysfunction (DD) or heart failure with preserved ejection fraction (HFpEF) may benefit from a higher backup heart rate (HR) setting than the factory setting of 60 beats per minute (bpm). In this prospective double-blinded randomized controlled study, pacemaker patients with DD or overt HFpEF and either 1) intrinsic ventricular conduction or 2) conduction system or biventricular pacing will be enrolled and randomized to either a personalized lower HR setting (myPACE group, based on a height-based HR algorithm) or to the standard 60bpm backup setting (control group) for 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Implanted pacemaker with either 1) intrinsic ventricular conduction or 2) conduction system or biventricular pacing or 3) RV pacing \<2% and paced QRS duration \<150ms
* Clinical evidence of heart failure with preserved ejection fraction or diastolic dysfunction, based on:

  * dyspnea with exertion
  * or NYHA Class ≥ II heart failure
  * or pulmonary edema on prior chest imaging or documented on exam
  * or is taking loop diuretics for heart failure
  * or had NTproBNP \>400 ng/ml in the last 24 months
  * or a heart failure hospitalization in the last 2 years
  * or has diastolic dysfunction on echo
  * or has left ventricular hypertrophy on echo
  * or has left atrial (LA) dilation (LA volume/BSA index \>28ml/m2)

Exclusion Criteria:

* Left ventricular ejection fraction \< 50%
* Life expectancy \< 12 months
* Symptomatic pulmonary disease on home oxygen
* Uncontrolled hypertension as defined by blood pressure \>160/100 mmHg on two checks ≥15 minutes apart
* Hypertrophic cardiomyopathy
* More than moderate valvular disease
* Aortic valve replacement \< 1 year
* Angina pectoris
* Creatinine \> 2
* Hemoglobin \< 8 g/dL
* Participation in another clinical trial or registry study
* Inability to follow up for regularly scheduled pacemaker appointments or to follow up for this study
* Pregnant patients or patients of childbearing age without reliable contraceptive agent (intra-uterine device, birth control implant, compliance with contraception injections or contraception pills) for the duration of study participation
Guanfacine for the Treatment of Spatial Neglect and Impaired Vigilance

To find out if spatial neglect following stroke and brain injury can be reduced using guanfacine, a drug that was shown to improve neglect in two stroke patients in a previous pilot study (Malhotra et al, 2006). In this trial, the effects of guanfacine will be examined in a larger number of patients, and there will also be a systematic assessment of whether the drug is only effective in patients with particular patterns of brain damage.

The current study has a double-blind crossover design where patients will receive a single 2mg dose of oral guanfacine and a single dose of placebo. They will receive one of these on Day 2 of the study period and the other on Day 4.

They will be tested daily on Days 1 to 5 so that any test repetition or long-term drug effects can be gauged.

On days 2 and 4 they will be tested twice-once prior to drug/placebo administration and again 90 minutes after drug/placebo administration.

Tests will include standard pen-and-paper tasks for neglect as well as computerised tests of sustained attention and visual exploration. In our published pilot study (Malhotra et al, 2006) there was a suggestion that patients without damage to frontal cortex were more likely to respond to guanfacine. In the current study we intend to test 10 patients with and 10 patients without frontal damage in order to test this further.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or more
* Greater than 2 weeks following stroke
* Ability to give consent
* Evidence of robust Visual Neglect when tested twice with cancellation tasks.

Exclusion Criteria:

* Less than 2 weeks following stroke
* Concomitant illness that may affect interpretation of any findings
* Labile blood pressure following stroke
* Systolic BP less than 100 mmHg and / or diastolic less than 70 mmHg
* New antihypertensive medication started within last 3 weeks
* Patients with hepatic or renal dysfunction
* Patients receiving other medications known to potentiate guanfacine's antihypertensive and hypotensive effects or cause torsade de pointes, specifically antipsychotics (including sultopride, chlorpromazine, thioridazine, amisulpiride, sulpiride, haloperidol), and moxifloxacin, baclofen, verapamil, quinidine, hydroquinidine, dispyramide, amiodarone, dofetilide, ibutilide, sotalol, pimozide, bepridil, cisapride, diphemanil, erythromycin IV, halofantrine, pentamidine, sparfloxacin, vincamine, alfuzosin, prazosin, terazosin, tamsulosin, amifostine
* Patients with diagnosis of brain tumour
* Patients with weight less than 55kg
* Patients who are pregnant
* Mothers who are breast feeding
* Patients with severe coronary insufficiency or myocardial infarction in previous 6 months
* Cognitive impairment, dysphasia or dementia that prevents patient from giving informed consent
* Severe mental impairment or physical handicap following stroke that prevents patients from giving consent or performing basic (standard clinical) tests for neglect
LifeSeal™ Pilot Study in Subjects Undergoing Circular Stapled Anastomosis Created Within 10 cm of the Anal Verge

A Pilot Study in Subjects Undergoing circular stapled anastomosis created within 10 cm of the anal verge.


Eligibility Criteria:
Inclusion Criteria:

1. Subject, or authorized representative, signed a written Informed Consent Form
2. Subject is 18 years or older
3. Subject is scheduled for elective open or laparoscopic surgery involving the creation of a circular stapled anastomosis created within 10cm from the anal verge.
4. If female - not be of child bearing potential, or be using acceptable contraception methods.
5. Subject participating in studies involving approved drug or device will be enrolled only following a mutual consideration of the investigator together with the Sponsor.

Exclusion Criteria:

1. Subject has a history of hypersensitivity to porcine derived gelatin or collagen
2. Subject participating in any other study involving an investigational (unapproved) drug or device.
3. Subject with a BMI higher than 40
4. Female Subject states that she is pregnant or breast feeding
5. Subject with ASA status higher than 3
6. Avastin use within 30 days prior to surgery
7. Subject who underwent a prior pelvic anastomosis
8. Subject is scheduled for another surgery during the follow up period of this study (not including stoma closure)
Clinical Evaluation Study for Assessing the Visual Performance of Hanita Lenses Trifocal IOL

Hanita Lenses Trifocal IOL, SeeLens AFR (Intensity IOL).Prospective, single-arm single-center, open-label study.

Device: Hanita Lenses Trifocal IOL, SeeLens AFR (Intensity IOL). Indication studied: The Hanita Lenses Trifocal IOL is intended for implantation in the capsular bag in the posterior chamber in order to replace the crystalline lens of the eye to attain visual correction of aphakia in adult patients in whom a cataractous lens has been removed, who desire improved uncorrected vision, useful near and intermediate visual functions, and reduced spectacle dependence.

Study description: This study is a prospective, single-arm single-center, open-label study.

Eligibility Criteria:
Inclusion Criteria:

* Age over 45 years and under 75 years.
* Patients with bilateral age-related cataracts, require bilateral cataract phacoemulsification combined Intraocular Lens implantation;
* Patients with an axial length of 22-24.5mm.
* Normal corneas with less than 0.75D of regular corneal astigmatism.
* Post-operative best-corrected visual acuity projected to be 0.3 logMAR or lower.
* Patient motivated for trifocal IOL after screening by the surgeon.
* Fundus visualization is possible.
* Absence of retinal or optic nerve diseases
* Signed informed consent

Exclusion Criteria:

* Previous ocular/corneal surgery that may affect refraction accuracy or visual acuity.
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
* History or evidence of any ocular disease that may affect visual acuity (i.e. uncontrolled glaucoma, ocular injury, corneal pathologies, retinal pathologies in general and macular pathologies in particular, diabetic retinopathy, uveitis, aniridia or iris atrophy, vitreous pathologies (patients with vitreous separation or floaters can be included).
* Rubella cataract.
* Amblyopia
* Any other ocular condition that may predispose a subject to future complications or contraindicate implantation of the trifocal lens.
* Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions)
* Patients with pupil diameter greater than 4mm in photopic conditions.
* Pregnant, lactating or planning to become pregnant during the course of the trial.
* Allergy or intolerance to required study medications (including antibiotic).
* Subjects participating in a concurrent clinical trial or if they have participated in an ophthalmology clinical trial within the last 30 days.
* Traumatic cataract.
Low Pulse Amplitude Seizure Therapy (LAP-ST Study)

This study assesses the feasibility of a full course of Low Pulse Amplitude-Seizure Therapy (LAP-ST) (primary outcome).

This is hypothesized to increase stimulation focality, thus minimizing cognitive side effects compared to conventional ECT. The study will enroll 22 patients recruited from the Behman Hospital, Cairo, Egypt. Patients referred to ECT service in the Behman Hospital who are clinically indicated to do ECT for major depressive episode of a mood disorder or psychotic episode of a primary psychotic disorder will be approached. Eligible participants who signed informed consent will be included to receive a course of Right Unilateral Ultrabrief LAP-ST.

Eligibility Criteria:
Inclusion Criteria:

1. ECT clinically indicated
2. Males or females over 22 to 80 years of age
3. Use of effective method of birth control for women of child-bearing capacity
4. Patient is medically stable
5. Capacity of patient to fully participate in the informed consent process as evaluated by their clinician

Exclusion Criteria:

1. Current unstable or serious medical condition, or any co-morbid medical condition that substantially increases the risks of ECT
2. History of conditions that may make ECT unsafe such as metal in the head, or a skull defect
3. Female patients who are currently pregnant or plan to be pregnant during the study
Incidence of H1N1v Influenza-like Illness and Risk Factors for Serious Influenza Forms in HIV Infected Patients

To estimate the incidence of H1N1v influenza-like illness and to study the risk factors for serious influenza forms during pandemic period in French HIV infected patients.

* Definitions:

  * Influenza like illness is defined as fever\> 37°8C and cough or pharyngalgia. (Centers for Disease Control definition).
  * Serious forms of influenza-like illness is defined by hospitalization within 14 days onset of symptoms or death attributed to influenza like illness.
* Design:

  * Survey sampling for estimating H1N1v influenza-like illness incidence.
  * Out of approximately 50 000 patients under follow-up in one of the 40 ANRS centres, a sub-group will be selected by random sampling. Sampling will be stratified by centre and sampling fraction per site will vary in order to select 60 to 80 patients for this study per site. A total of 2500 to 3000 patients will be selected to allow for estimating the incidence of H1N1v influenza-like illness with an adequate precision.

Selected patients will be asked to contact the clinical staff on site as soon as any influenza like symptoms appear. In the case of influenza like illness patients are requested to attend to the clinic within 24 hours for physical examination and naso-pharyngeal swab for diagnosis of A(H1N1)v infection.

Nested case-control study for the determination of risk factors for serious forms:

* Cases: Serious forms (see definition above) identified by any clinical site or hospitalisation unit.
* Controls: Patients of the randomly selected sample (see survey sampling above), presenting with influenza-like illness without any criterion for severity.

Exhaustivity check:

The exhaustivity of symptomatic forms will be assessed a posteriori by merging information from all available data sources.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Able to give written consent
* Covered by French Social Security
* HIV-infected (infection attested by the patient's chart)
* pregnant women

  * Control and sample to estimate incidence
* Patients followed for their HIV-infection in an ANRS center

  * Serious form
* Hospitalization whatever is the service in 14 days consecutive to a H1N1v influenza syndrome such as defined, or death consecutive to a H1N1v influenza syndrome such as defined.

Exclusion Criteria:

* patients for whom a H1N1v influenza syndrome can be informed at the beginning of the study.
* Under protection(saving) of justice
Oral Candida in Infants and Dietary Type

This is an observational, non-randomised trial to evaluate the effect of dietary type on infants oral candida colonization the investigators evaluated 90 infants in 1-24 months (45 breastfeeding and 45 bottle feeding infants) who attended to Yazd clinic for regular pediatric appointment. Infants with unremarkable health histories, normal weight, free of sign or symptom of oral candidiasis or other mucosal disease. Their mothers were also healthy and without sign or symptom of vagina or mammary candidiasis. Pacifier usage, use of antibiotics in last months, sign or symptom of oral candidiasis in infants or vagina and mammary candidiasis in mothers were exclusion criteria.

After filling in a questionnaire about infants dietary intake, age and sex and their mothers education level and health condition, a pre-moistened sterile cotton swab was taken from dorsal surface of tongue and mid-plate. The swabs were cultured in agar plate containing sabourauds dextrose agar medium with chloramphenicol, and kept in 37 C for 48 hours. The number of candida colonies was counted and germ tube test performed to separate candida albicans from other types. The data was collected and analyzed by SPSS software and chi-square, logistic regression and mann-whitney test. Study hypothesis: feeding by mothers milk reduces oral candida colonization.

Eligibility Criteria:
Inclusion Criteria:

* healthy infants
* healthy mothers

Exclusion Criteria:

* pacifier usage
* use of antibiotics in last month
* sign or symptom of oral candidiasis in infants
* vagina and mammary candidiasis in mothers
National Trial of CGM in Pregnant Women With Type 2 Diabetes

The goal of this clinical trial is to evaluate the use of glucose sensors in pregnant women with type 2 diabetes to improve insulin regulation, pregnancy and birth outcomes, and enhance quality of life and satisfaction with treatment.

The main questions it aims to answer are:

* Does the use of glucose sensors during pregnancy lead to a clinically significant reduction in HbA1c by 0.3% at 36 weeks gestation compared to the control group?
* Does the use of glucose sensors during pregnancy result in a clinically significant reduction in mean SD-score for birth weight deviation in newborns compared to the control group?

Researchers will compare the group of women using glucose sensors during pregnancy to a historical control group receiving routine care to see if the sensor improves pregnancy outcomes, glucose control, and birth weights.

Participants will:

* Use a glucose sensor from before 14 weeks of pregnancy until 4-6 weeks postpartum.
* Receive training on how to use the sensor and access ongoing support as needed.
* Have a follow-up appointment 4-6 weeks postpartum, including a consultation for advice on medical treatment and further management of diabetes after birth.


Eligibility Criteria:
Inclusion Criteria:

* pregnant women with type 2 diabetes
* attending one of the four centers for pregnancy and diabetes in Denmark
* 18 years old or above

Exclusion Criteria:

* gestationel age 14+0 or above
* ekspected birth after end of trial
* already using a continous glucose monitor (sensor)