cyrilzakka/clinical-trials huggingface dataset:
Focus Group Interviews of Patients With Permanent or Temporary Enterostomas

The study seeks to gain knowledge about new and of alternative ways of organizing ostomy training based on informants' own experiences of life with a stoma.

The study is designed and conducted as qualitative focus group interviews with three different groups of patients with enterostomas (5-8 in each group): a) people with permanent enterostoma due to cancer, 2) people with permanent enterostoma due to non-cancer and 3) people with a temporary ileostomy.

The study is investigating the perspective of the patients who have actually experienced having surgery and living with an enterostoma.

By applying this method it is possible to gain access and in depth knowledge of complex issues including sensitive data. The dialogue with peers can lead to experiments and associations which might stimulate the informants to produce new insights within the individual and in the group.

The interviews will be transcribed in full and analyzed with qualitative content analysis with a phenomenological and hermeneutical approach

Eligibility Criteria:
Inclusion Criteria:

* Patients with permanent enterostoma due to cancer.
* Patients with permanent enterostoma due to other causes.
* Patients with temporary ileostomy.

Exclusion Criteria:

* Patients with severe mental disorders.
* Patients who do not communicate in Danish.
* Patients with severe hearing impairment.
The Effect of Acute Phase Treatment Approaches on Creatine Kinase and the Musculoskeletal System in Different Types of Burns

There are very few studies indicating the effect of acute phase treatment approaches on creatine kinase and the musculoskeletal system in the physiotherapy and rehabilitation process. Rehabilitation in burn patients is a benchmark due to return to pre-burn life. Therefore, this study was conducted to determine the effect of acute phase treatment approaches on creatine kinase and the musculoskeletal system in different types of burns.

In the literature, there are very few objective and quantitative studies comparing the effects of standard wound care and rehabilitation period on different burn types in burn patients. Thus, our study was designed to investigate the effects of acute phase treatment approaches on creatine kinase and the musculoskeletal system in different types of burns.

Eligibility Criteria:
Inclusion Criteria:

* the study were being aged between 18-65 years and having different burn types, and flame, scald, and electrical burns were included in the study.
* The burn percentage and mortality percentage were calculated, and patients with a burn percentage of less than fifty percent were included.

Exclusion Criteria:

* the study were having a systemic disease, having substance abuse, and having a burn percentage of more than fifty percent.
Comparing the Efficacy of Different Iron Formulations: Sucrosomal Ferric Pyrophosphate, SunActive®Fe and Intravenous Ferric Gluconate

The purpose of the study is to evaluate the effects of martial therapy, comparing different formulations, sucrosomal ferric pyrophosphate, SunActive®Fe micronized and ferric gluconate and different ways of administration, orally and intravenous, in subjects affected by sideropenic microcytic hypochromic anemia identified by the simultaneous presence of anemia, microcytosis and hypoferremia.

Background: Iron deficiency anemia (IDA) still remains universally a worldwide problematics. Anemia is defined as a hemoglobin value \<12.0 g/dL (7.45 mmol/L). Management of IDA is based on martial iron supplementation. The purpose of the study is to evaluate the effects of martial therapy, comparing different formulations, sucrosomal ferric pyrophosphate, SunActive®Fe micronized and ferric gluconate and different ways of administration, orally and intravenous, in subjects affected by sideropenic microcytic hypochromic anemia identified by the simultaneous presence of anemia, microcytosis and hypoferremia.

Trial Design, Methods and Findings: Clinical data from 106 outpatients (82.8% female and 17.2% male, mean age 50.4 years) were collected at Department of Internal Medicine, National Relevance and High Specialization Hospital Trust, ARNAS Civico-Di Cristina-Benfratelli, Palermo, Italy. The study envisaged five arms (2 + 3). At the first two arms were assigned patients with non-severe anemia Hb\> 10 g/dl (Hb \<12 g/dl for women and Hb \<13 g/dl for men), treated with SunActive®Fe micronized or Lipofer®. At the other three arms were assigned patients with severe anemia (Hb \<10 g/dl) treated respectively with SunActive®Fe micronized, Lipofer® or with intravenous ferric gluconate infusions according to departmental protocols. The followed methodology is defined in the PROBE project (acronym of Prospective Randomized Open Blinded End-point). The end points will be blinded with respect to the three treatments, as it will be the statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of iron deficiency anemia, microcytic and hypochromic
* Age \>18

Exclusion Criteria:

* Diagnosis of Celiac Disease
* Patients who refuse to sign the informed consent
* Clinically relevant cognitive Turbe
* Hemodynamic instability defined by the presence of low blood pressure SBP \<100 FC\> 100
* Dyspnea after modest effort worsening over the past 10 days
* Oxygen peripheral saturation values \<94%
* Ischemic heart Recent and / or lower limbs
* Acute conditions with subacute or at recruitment
Evaluate the Safety, Tolerability, & Pharmacokinetics of K-285 Compared With Indomethacin Capsule in Healthy Adults

This study is to compare the PK parameters of multiple doses and applications of K-285 with a single dose of indomethacin capsule.


Eligibility Criteria:
Inclusion Criteria:

* Subject provides written informed consent before any study specific evaluation is performed.
* Subject is a healthy adult male or female aged 18 to 45 years, inclusive.
* Subject has a BMI of 18 to 30 kg/m2, inclusive.
* Subject meets all inclusion criteria outlined in the clinical study protocol.

Exclusion Criteria:

* Subject has abnormal findings or assessments that are clinically noteworthy at Screening or Admission (Day -1).
* Subject has a supine blood pressure after resting for 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 50 mm Hg diastolic at Screening or Admission (Day -1).
* Subject has a supine heart rate after resting for 5 minutes that is outside the range of 40 to 100 beats per minute at Screening or Admission (Day -1).
* Subject does not meet any exclusion criteria outlined in the clinical study protocol.
Antisense Therapy to Block the Kallikrein-kinin Pathway in COVID-19

Up to 1/3 of all patients infected with COVID-19 can develop complications that require hospitalization. Severe pneumonia associated with acute respiratory distress syndrome (ARDS) is the most threatening and feared complication of COVID-19 infection, with mortality rates close to 50% in some groups.

Autopsies between these severe cases reveal severe capillary involvement, with signs of intense inflammatory changes, microvascular thrombosis, endothelial injury and abnormal tissue repair. The available evidence suggests that abnormal activation or imbalance in the counter-regulation of the kallikrein-kinin system may play a central role in a positive feedback cycle, leading to consequent diffuse microangiopathy. Blockade of the kallikrein-kinin system can therefore prevent deterioration of lung function by reducing inflammation, edema and microthrombosis.

The objective of this phase IIb study is to assess the preliminary effects on the oxygenation parameters of an antisense oligonucleotide that inhibits pre-kallikrein synthesis in patients with moderate to severe COVID-19.

The objective of this phase IIb study is to assess the preliminary effects on the oxygenation parameters of an antisense oligonucleotide that inhibits pre-kallikrein synthesis in patients with moderate to severe COVID-19.

This is a blind randomized pilot clinical study which aims to include 110 patients (55 per arm).

Eligibility Criteria:
Inclusion Criteria:

1. Patients with COVID-19 who need supplemental oxygen
2. Women must not be pregnant or breastfeeding, and must be surgically sterile or in the postmenopausal stage (without risk of becoming pregnant).
3. Men must be surgically sterile or abstinent or, if they are having sex with risk of pregnancy, the subject must use an effective method of contraception from the moment they sign the informed consent form until at least 24 weeks after the dose of the study drug (ISIS 721744 or placebo).

Exclusion Criteria:

1. Patients on invasive mechanical ventilation or who may need mechanical ventilation for the next 24 hours. The use of non-invasive ventilation and/or a high-flow nasal catheter is permitted.
2. Patients with \> 10 days since symptom onset or more than 48h of oxygen use
3. Pregnancy, breast-feeding or risk of becoming pregnant
4. Hemodynamically unstable (use of vasoconstrictors, such as norepinephrine, at any dose)
5. Previous diagnosis of heart failure at functional class III or IV
6. Previous uncontrolled hypertension (more than 3 drug classes use at home)
7. Severe lung disease (use of home oxygen)
8. Age \< 18 and \> 80 years
9. Physician and family not committed to full life support and/or with severe existing illness with a life expectancy of less than 12 months
10. Refusal to accept informed consent and/or unwillingness to comply with all requirements of the study procedure and security monitoring
Evaluation of 3 Intraocular Lenses Following Lens Extraction

The objective of this study is to evaluate the efficacy and subject satisfaction with three different FDA approved lenses for adults over 40 years of age who desire a reduction in spectacle dependence.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a clinically documented diagnosis of age-related bilateral cataracts that are considered amenable to treatment with standard phacoemulsification cataract extraction.
* Subjects must require a spherical lens power from 10.00 D to 33.00 D
* Subjects must have the potential for corrected distance visual acuity (CDVA) of 20/32 or better in both eyes, as documented by a Potential Acuity Meter

Exclusion Criteria:

* Subjects with conditions with increased risk of zonular rupture, such as pseudoexfoliation syndrome. Zonular rupture during cataract surgery may affect postoperative centration, tilt, and stability of the lens.
* Subjects who have any active inflammation or edema (swelling) of the cornea, including but not limited to the following: keratitis, keratoconjunctivitis, and keratouveitis.
* Subjects with visually significant diabetic retinopathy (proliferative or non-proliferative) which reduces potential acuity to 20/32 or worse.
Cognitive Ability Training for Seniors With Mild Cognitive Impairment

This study investigates the beneficial effects of prefrontal brain stimulation (with transcranial direct current stimulation \[tDCS\]) during working memory training in seniors with mild cognitive impairments.The placebo-controlled double blinded study includes 50 elderly patients which will be randomized into verum or sham tDCS.

In this project, we want to test whether the effectiveness of neuropsychological exercise therapy can be increased in elderly persons suspected of having an MCI by means of parallel tDCS treatment.

All test participants train over 6 sessions within 2 weeks two different working memory tasks with increasing difficulty. In the randomized, double-blind, prospective therapy study, participants are assigned to either a Verum-tDCS or a placebo-tDCS group. The Verum-tDCS group receives active stimulation in parallel to the exercise therapy, while the placebo group does not receive tDCS stimulation. To check the effects of the therapy, we measure performance and neuronal activation in different executive tasks using near-infrared spectroscopy (NIRS). Furthermore, we will check whether the training increases the volume of the grey matter (Draganski et al., 2004, Malchow et al., 2016) and the expression of BDNF can be increased (Schuch et al., 2015).

Eligibility Criteria:
Inclusion Criteria:

* suspected MCI
* total CERAD score \<= 85.1
* MMSE \>=24
* native german speaker
* between 50-75 years old
* right handed

Exclusion Criteria:

* impairment of daily living activities
* psychiatric, neurological diseases
* uncorrected hearing or vision deficits
* actual psychopharmaca intake
* metal parts in the head
* medical electronical implants
Pilot Evaluation of the Cynosure Potenza™ System for Treatment of Cosmetic Dermatologic Skin Conditions

The primary objective of this pilot study is exploratory investigation evaluating the Potenza microneedle fractional radiofrequency (RF) device and may be used in combination with the Icon intense pulsed light (IPL) device.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female 18 years of age or older.
* Presence of unwanted dermatologic condition suitable for treatment such as facial and/or neck wrinkles, skin laxity of face, neck or body, scars, acne scars or striae, or Vascular and/or pigment dyschromia
* Ability to read, understand, and sign the Informed Consent Form
* Understands and accepts the obligation not to undergo any other procedures in the areas to be treated and/or weight loss through the follow-up period.
* Willing and able to comply with all study participation requirements including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study

Exclusion Criteria:

* Is pregnant or of childbearing potential and not using (or willing to use) medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
* Presence of an active systemic or local skin disease or condition that may affect wound healing or interfere with participation.
* History of keloids or poor wound healing
* Taking medication which is known to increase sensitivity to sunlight
* Has a seizure disorders triggered by light
* Cancer, malignant disease, skin pathology, condition or allergic reactions that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments
* History of collagen, vascular or immunosuppressive or deficiency disorders
* History of coagulative disorder or use of anticoagulant drugs within 2 weeks of study treatment
* Use of steroids within 2 weeks of study treatments
* Use of Accutane (isotretinoin) in the past 12 months
* Previous surgical or cosmetic procedure to the target area in the last 6 to 12 months that could interfere with the treatment procedure and affect treatment outcome
* Has an implanted pacemaker or defibrillator, metal pins or prosthetic joints
* Allergic reaction to gold metal
* Receiving or have received gold therapy
* Photo-sensitive skin
* Psycho-neurotic condition including alcohol or drug abuse
* Unwilling or unable to adhere to all study requirements for treatment and follow-up
* Has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
Sensors for Communication for Persons Who Cannot Communicate Unequivocally

Some persons with intellectual disability or comprehensive cerebral palsy cannot communicate unequivocally how they are, how they react to situations and people, whether they are in pain or experience discomfort, anger or fear. Their modes of communication (sounds, grimacing etc) may be unintelligible or ambiguous to their caregivers.

With the use of heart and/or respiration monitors the investigators aim to give these persons a means to communicate their immediate reactions or responses. The respiration monitor is meant to register sleep at night, so that the participants can communicate whether they have slept well or not the previous night.

Heart rate (HR) is considered to reflect a persons autonomic response to situations, whether external (what happens around us) or internal (pain or pleasure, joy or fear). Some persons with severe intellectual disability or comprehensive cerebral palsy or childhood autism cannot communicate unequivocally, either because they lack the cognitive prerequisites and language or because they lack control over their muscles used for speech.

The investigators believe that these persons, through their heart rate, as registered with a commercially available chest belt or wrist watch, may communicate something about their well being and their reactions, preferences, aversions and fears.

Many persons with intellectual disability, comprehensive cerebral palsy or childhood autism (the participants in this study) have sleep problems, but these may go unnoticed. Participants often have a fixed schedule for the day, and this is carried out irrespective of the shape they are in, e.g. irrespective of how well they have slept the night before. The challenges may then be too much for a sleep-deprived person, and frustration and even self harm and aggressive behavior may be the result. With the use of a respiration monitor that assesses sleep from the person's breathing pattern, the person in question may be able to communicate to her/his caregivers how the previous night's sleep was.

Information about heart rate and sleep may contribute to better care and health services for persons who are unable to communicate unequivocally because of intellectual disability, autism and/or cerebral palsy.

Eligibility Criteria:
Inclusion Criteria:

* intellectual disability with or without autism and/or cerebral palsy that render the participant unable to communicate his/her needs and reactions unequivocally.

Exclusion Criteria:

* allergic skin reaction to chest strap
A Study to Assess How the Body Processes a Strong Painkiller When it is Given Alongside a Drug That Counteracts the Side Effects of Strong Painkillers in a Fasted and Fed State.

To assess whether an opioid antagonist has any impact on the release of a strong painkiller in the blood when it is given to healthy volunteers when they have eaten and also when they have fasted.

This is an exploratory study to assess the influence of an opioid antagonist on the pharmacokinetics of a strong painkiller when co-administered in a fasted and fed state.

Determination is by measurement of drug concentrations in the blood at serial collection time points pre-dose until 32 hours post-dose, following an administration of a single oral dose. Pharmacokinetics parameters of AUC and Cmax are the primary endpoints.

Eligibility Criteria:
Healthy male or female subjects aged 18 to 55 inclusive Healthy and free of significant abnormal findings as determined by medical history, physical examination, vital signs, laboratory tests and ECG.
Assessing Perceptual Effects of Interactive Tasks

In this study, we will evaluate how solo, naive listeners perceive the speech of people with amyotrophic lateral sclerosis (ALS) and age-matched speakers produced across interactive and non-interactive contexts with an unfamiliar, naive interlocutor.

Listeners will hear recorded speech of PALS and age-matched speakers and indicate what they heard. Recorded speech consists of vowels and consonants produced in non-interactive and interactive tasks. The perceptual judgements will be compared to see whether interactive contexts have similar perceptual effects across the two groups.

Plans for Assignment - This is a single group study in which all participants will engage in the same tasks.

Delivery of Intervention: Solo listeners will participate in this study in a remote, asynchronous format. They will be recruited using the online participant recruitment platform Prolific © and will use their own laptop/computer and headphones.

Adequacy of Sample size: We will use n = 1300 listeners to achieve 80% power at alpha of .05 to detect between group differences with the assumption of medium effect sizes (Cohen's f = 0.3).

Adequacy of Analyses: The proposed statistical analyses (Generalized mixed effects regressions) are standard and will be used to analyze the effect of the intervention on the outcome measures described below.

Eligibility Criteria:
Inclusion Criteria:

* passing the remote hearing screening
* having no known speech, language or neurological disorders per self-report
* being a native monolingual speaker of American English
* having no experience communicating with people with dysarthria
* being between the ages of 18 and 65.

Exclusion Criteria:

* None - if volunteer meets the inclusion criteria, then they will be enrolled
Mayo Designed Soft Tissue Ultrasound-Detectable Marker

Researchers are trying to determine if the Mayo marker is easily seen with ultrasound making it easier, faster, and more accurate for preoperative localization of the biopsied positive lymph node.

Nonrandomized clinical trial to evaluate the Mayo-designed marker for ultrasound conspicuity at the time of preoperative ultrasound-guided localization.

Study participants are breast cancer patients with pathology-proven metastatic axillary lymph nodes. Per standard of care, a biopsy marker will have already been associated with the positive lymph node. 10 such patients scheduled for surgery at Mayo Clinic Rochester, MN with Dr. James Jakub will be enrolled. Preoperative radioactive seed localization will proceed as usual, but the marker will be additionally loaded with the seed into the needle using standard protocol. Before surgery, ultrasound will be performed to evaluate the marker.

Eligibility Criteria:
Inclusion Criteria:

* Patient 18 years or older with breast cancer and biopsy-proven malignant involvement of an axillary lymph node
* Surgical management involves preoperative radioactive seed localization of a previously identified positive axillary lymph node
* Surgery will be performed by Dr. James Jakub at Mayo Clinic Rochester, MN
* Radioactive seed localization of an axillary lymph node.
* No contraception is necessary or required.
* English speaking

Exclusion Criteria:

* Scheduled for only radioactive seed localizations in the breast (as opposed to axilla)
* Are pregnant; although the twinkling marker is made of material widely used in orthopedic procedures, and hence, has an excellent safety profile, the investigators want to exclude the population of pregnant patients in this phase 0 clinical trial.
Evaluation of Intern Dentists in Emergency Management of Traumatic Dental Injuries in Primary Anterior Teeth

This study aim to evaluate knowledge, attitude, and practice of intern dentistry in emergency management of traumatic dental injures in primary anterior teeth in children aged from 3-5 years old. Questionnaire survey will be designed to evaluate Knowledge - Attitude - and practice of intern dentists who met the eligibility criteria

Questionnaire survey will be designed to evaluate Knowledge - Attitude - and practice of intern dentists toward different forms of traumatic dental injuries in primary anterior teeth in children aged from 3 to 5 years old.

Eligibility Criteria:
Inclusion Criteria:

* Intern dentists attending their internship in Faculty of Dentistry- Cairo University, other private university (Modern Science and Arts University- MSA).
* The intern dentists who agree to participate.
* Intern dentists who did not attend Pediatric Dentistry round, Endodontic round, Emergency round and Surgery round at Cairo University.
* Intern dentists irrespective of age and sex.