cyrilzakka/clinical-trials huggingface dataset:
Development of a Cellular Biomarker for the Diagnosis and Treatment of Diabetic Foot Ulcers

This project aims to result in the identification of such markers, and the development of a feasible quantitative method of distinguishing between tissue that has the capacity to heal and tissue that does not, thus identifying a non-healing phenotype.

The goal of this project is to identify objective, quantitative biological and molecular markers that correlate with healing outcomes for diabetic foot ulcers (DFUs) using debrided tissue of patients with wounds. This project aims to result in the identification of such markers, and the development of a feasible quantitative method of distinguishing between tissue that has the capacity to heal and tissue that does not, thus identifying a non-healing phenotype. The ability to differentiate between healing and non-healing tissue at the onset of wound care will allow for the use of targeted therapies and earlier initiation of aggressive treatments where indicated.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age ≥ 18
* Type 2 Diabetes
* A break in the skin on the foot ≥ 0.5cm2 and is Grade 1 or 2 as defined by the Wagner grading system
* Hemoglobin A1c ≥ 5.9%
* Ability to provide written informed consent

Exclusion Criteria:

* Any experimental drugs taken orally or topically within 4 weeks of study entry
* Malignant disease at/or in proximity to the DFU
* Target wound of malignant origin
* Failure to satisfy at least one inclusion criterion for one of the two study groups.
Effects of an Active Break Program at Primary School

The purpose of this study is to assess the effectiveness of an active break program at school on physical activity levels and enjoyment, and on-task behavior in children.

The protocol will include third and fourth-grade students (children aged 8 to 10 years) from elementary schools in the Valparaíso Region, Chile. Four school classes from two schools (intervention and control school) will be included. The intervention school will carry out the active break program, ACTIVA-MENTE This program consists of the application of a 4-and-a-half-minute video with moderate to vigorous-intensity physical activity. These breaks will take place 6 times a day in classes for 6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Schoolchildren aged 8 to 10 years old (third to fourth grade of primary education).

Exclusion Criteria:

* Children with school attendance lower than 90 per cent (excluded from data analysis).
* Any medical condition that impedes physical activity breaks.
Inhaled Steroid Treatment as Regular Therapy in Early Asthma

A study of the effect of the early treatment with Pulmicort of newly diagnosed asthma. Patients will receive either Pulmicort or a non-active treatment for three years. Neither patients or investigators will be aware of the treatment received. After three years of treatment all patients will receive Pulmicort for 2 further years.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients aged between 6 and 60 years
* diagnosed with asthma within 2 years of starting the study
* Ability to use a Turbuhaler

Exclusion Criteria:

* Symptoms indicating asthma (e.g. wheezing) for more than two years prior to starting the study
* A history of the use of treatments like Pulmicort for more than 30 days per year in the two years before starting the study
* Regular daily treatment for asthma for more than two years before starting the study
Transvaginal Ultrasound and Photoacoustic Imaging of Ovary

This study is being conducted to validate if photoacoustic imaging potentially reduces benign surgeries without compromising cancer detection sensitivity. The study will also explore whether using the photoacoustic imaging/ultrasound technique has any potential with early ovarian cancer detection in a group of high risk patients.

In primary and secondary objectives, the investigators will consent patients who are at risk for ovarian cancer, or who have an ovarian mass possibly suggestive of a malignancy and are counseled to undergo oophorectomy. Patients will be identified by the GYN physicians and consented by the study coordinator prior to the date of the scheduled surgical procedure.

In exploratory objectives, the investigators will consent patients who are at risk for ovarian cancer and wish to be followed before making decision to undergo prophylactic oophorectomy. Patients will be identified based on the eligibility criteria by the physicians and consented by the study coordinator prior to the follow up studies.

Eligibility Criteria:
Inclusion Criteria for Primary and Secondary Outcome Measures

* All patients, 18 years or older, referred to the Washington University School of Medicine for conditions necessitating surgery to include at least a unilateral oophorectomy.
* Willingness to participate in the study and able to provide informed consent.

Inclusion Criteria for Exploratory Outcome Measures

* At least 18 years of age
* Referred to the Washington University School of Medicine for conditions necessitating surgery to include at least a unilateral oophorectomy, an ovarian cystectomy, or a unilateral or bilateral salpingectomy .
* Willing to be followed for one to 4.5 years prior to making the decision to undergo prophylactic oophorectomy.
* Documented deleterious mutation in one of the following ovarian cancer genes: BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1, PMS2, or EPCAM.

Exclusion Criteria:

* Male
* Younger than 18 years of age
A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Amlodipine in Healthy Male Subjects

The purpose of this study is to evaluate the pharmacokinetics and safety when administrated Fimasartan/Amlodipine and when co-administrated Fimasartan and Amlodipine.

This is an open-label, randomized, 3x3 partial replicated crossover study to evaluate the pharmacokinetics and safety/tolerability. Within each period, randomized subjects will be 2 dosing regimens with a fixed dose combination of Fimasartan/Amlodipine and co-administration of Fimasartan and Amlodipine.

Eligibility Criteria:
Inclusion Criteria:

1. Male 19-50 years of age.
2. Body mass index (BMI) ≥ 18 and ≤ 27 kg/m2 at screening.
3. Medically healthy with no clinically significant medical history.
4. Understands the study procedures in the Informed consent form (ICF), and be willing and able to comply with the protocol.

Exclusion Criteria:

1. History or presence of clinically significant medical or psychiatric condition or disease.
2. Positive results at screening for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV).
3. Seated blood pressure is less than 100/65 mmHg or greater than 140/90 mmHg at screening.
4. Plasma donation within a month prior to the first dose of study drug.
5. Participation in another clinical trial within 3 months prior to the first dose of study drug(s).
The Impact of Grapefruit Juice on the Response to Clopidogrel

This study will measure the percentage of platelet aggregation inhibition with a loading dose of clopidogrel (300 mg) using the VerifyNow Assay System in healthy volunteers who have drank 11 oz of grapefruit juice. It will also measure the percentage of platelet aggregation inhibition with a maintenance dose of clopidogrel (75 mg/day) using the VerifyNow Assay System in healthy volunteers who have drank 11 oz grapefruit juice daily.

This study will examine the effect of GFJ on the loading dose (300 mg) of clopidogrel and will evaluate the effect of GFJ on the maintenance dose (75 mg/day) of clopidogrel. Subjects will be randomized to either initially receive GFJ prior to their loading dose of clopidogrel or receive GFJ prior to their second loading dose. The subjects who have been randomized to receive GFJ initially will drink two small cans (11 oz total) of regular strength GFJ in the morning, followed two hours later by a loading dose (300 mg) of clopidogrel and will then return to the clinic 6 hours after their loading dose to have their platelet inhibition measured. Subjects will have \~ 5 milliliters (1 teaspoonful) of whole blood drawn from an antecubital vein in their forearm via a 21 gauge needle attached to a blue-top plastic vacuette sodium citrate blood collection (Greiner, Monroe, NC) tube to test inhibition of platelet aggregation. After their first loading dose, a 2 week washout period will follow to allow for their platelet aggregation to return to normal. Following the washout period, the subjects will take their second loading dose of clopidogrel and again return to the clinic for platelet inhibition measurement. The same timing will be followed for the loading dose taken without prior GFJ.

During the maintenance dose phase of this study, subjects will take 75 mg/day clopidogrel for 7 days with or without GFJ. Subjects will be randomized to either GFJ during the first period or GFJ during the second period. A minimum 2 week washout period will occur between the two 7 day courses of clopidogrel. Platelet inhibition measurement will occur at the end of each 7 day period as described above.

Eligibility Criteria:
Inclusion Criteria:

* Ages 19-40
* Health status confirmed by medical history and physical examination and laboratory analysis

Exclusion Criteria:

* Pregnancy
* Taking routine prescription or over-the-counter prescriptions
* Taken over-the-counter analgesic/anti-inflammatory medication within two weeks of study participation
* Recently had grapefruit juice or regularly drinks grapefruit juice
Topical Acetaminophen for Itch Relief: a Proof of Concept Study in Healthy Subjects

Currently, topical antihistamines and corticosteroids are mainly used for itching relief. However, the over the counter antihistamines are not effective on all itch conditions. Acetaminophen is a popular and widely used OTC drug for pain relief. Although its mode of action is still unknown, recent studies have shown that acetaminophen indirectly activates cannabinoid CB1 receptors. Recent studies have shown that topical cannabinoid agonists are effective for itch relief, the efficacy of topical acetaminophen will be tested for non-histaminergic itch relief.

This will be a single-blinded, vehicle-controlled randomized study in healthy controls to test the efficacy of the topical gel formulation with three differing concentrations of acetaminophen (APAP) for itch relief. To detect medium effects of the treatments with a given α of 0.5 and an error probability of 0.05, with a power of 0.95, the number of participants needed is 36 (10 within post hoc pairwise comparisons).

Eligibility Criteria:
Inclusion Criteria:

1. Healthy subjects must be between 18 and 50 years of age.
2. Must be in general good health with no disease or physical conditions that would impair evaluation of itch and pain perception.
3. No history of chronic itch or pain.
4. Must abstain from the use of any systemic or topical anti-histamine, steroid, or pain relief medications from the week prior to the study till the completion of the study.
5. Must abstain from the use of moisturizers on the arms 24 hours before study visits.

Exclusion Criteria:

1. Individuals under 18 or over 50 years of age.
2. Inability to complete the required measures.
3. The presence of an itchy skin disease.
4. Diagnosis of diseased that would affect itch or pain perception (e.g. neuropathies).
5. Currently enrolled in any investigational study in which the subject is receiving any type of drug, biological, or non-drug therapy.
6. Use of oral, topical analgesics, or other medications known to interfere with itch or pain perception in the week prior to the study and throughout the study (e.g. antihistamines, anesthetics, opioids, neuroleptics, etc.).
7. Use of emollients on the arms a week prior to the study and throughout the study.
8. Known allergies to acetaminophen and cowhage.
9. Pregnant women. (Women of child bearing potential will undergo an hCG pregnancy test).
10. Currently incarcerated.
Height, Ulnar Length and Forearm Function in Multiple Hereditary Exostoses

the purpose of the present registry is to describe the epidemiology of forearm deformities in patients with Hereditary Multiple Exostoses and to identify, independent predictors of severity of the disease and potential association with genotypic patterns

Hereditary Multiple Exostoses (HME) is a rare pediatric autosomal dominant disorder caused by loss-of-function mutations in the genes encoding the heparan sulfate (HS)-synthesizing enzymes EXT1 or EXT2. HME affects 1 in 50,000 people and has 100% penetrance but great variability in phenotypic expression. HME is characterized by formation of cartilaginous outgrowths, called osteochondromas or exostoses, next to the growth plates of many axial and appendicular skeletal elements, causing multiple, painful disfiguring and disabling skeletal deformities, and potential malignant transformation into peripherral chondrosarcoma.

The involvement of upper-limb bones by HME is associated with greater loss of function than elsewhere in the body, but even here the loss of function may be limited. Moreover, the constant relationship between height and ulnar length has long been recognized in forensic medicine and has been recently analyzed also in HME, in order to predict the clinical and functional outcomes of the upper limb.

the present registry aims to collect demographic, clinical, functional and radiographic information from patients with HME in order to establish phenotypic predictors of severity of the disease and potential association with genotypic patterns

Eligibility Criteria:
Inclusion Criteria:

- patients with HME (\> 2 exostoses)

Exclusion Criteria:

* Patients with solitary exostoses
* Patients, adults or minors, who are unable to give their timely informed consent.
Compound Phellodendron Decoction May Promote Wound Healing After Anal Fistulotomy

Sitz-bath therapy with Chinese medicine has significant advantages in the management of postoperative wounds of anal fistula. This method not only ensures safety, efficacy, and cost-effectiveness, but also simplifies application. With a firm foundation in a historical heritage, this method is notable for their minimal adverse reactions. The fumigating-washing or sitz-bath therapy with Compound Phellodendron Decoction (CPD) for postoperative wounds of anal fistula has demonstrated efficacy in mitigating pain, reducing edema, curbing secretions, alleviating skin itching, and promoting wound healing processes. Despite the body of clinical research in this domain is substantial, the majority of studies have been limited to observing therapeutic outcomes. The intrinsic mechanisms by which these effects are achieved remain elusive. This study aims to unravel the potential mechanisms underpinning CPD's promotion of wound healing, focusing on the aspects of inflammation and immunity.


Eligibility Criteria:
Inclusion Criteria:age range of 18 to 80 years who had undergone anal fistulotomy procedures.

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Exclusion Criteria:patients with Crohn's disease, pregnancy or lactation, organ dysfunction (such as heart failure, respiratory insufficiency, liver or renal impairment, gastrointestinal dysfunction), coagulopathy, autoimmune diseases, or a history of hypersensitivity to Chinese medicinal substances.

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Clinical Trial of an MRI Based Patient Specific Focal Knee Resurfacing Implant

The goal of this study is to evaluate the efficacy, safety and performance of the Episealer® device in a sample size of 30 patients and on the long term (10 years follow-up).

Lesions in the cartilage are common disorders. In the knee, cartilage lesions are found in over 50 % of all arthroscopies, where 25 % of these are of focal character and the majority are found in the medial femoral condyle. The quality of life of patients with focal cartilage defects is significantly affected and it has been shown that the quality of life is affected to the same extend as in patients scheduled for knee replacement. Arthroscopy lavage and debridement micro fracturing, mosaic plasticity as well as osteochondral autograft transplantation (OATS) are methods used for treatment of the lesions. Some have shown to help the patients but there is an ongoing treatment gap especially for patients with knee lesions and early osteoarthritis.

Episurf Medical has developed a Focal Knee Resurfacing (FKR) implant, the Episealer® implant. The implant is used for treatment of focal cartilage lesions of the lateral or medial femoral condyle in order to alleviate pain and improve range of motion. The implant and surgical instruments are customized to each patient's joint anatomy, position, and size of injury, based on patient-specific images (MRI). The Episealer® device is CE marked.

The Episealer® implant consists of a peg and a hat. The implant exists in five different diameters (12,14,17, 20 and 25mm), depending on the lesion size. The shape of the hat is circular or oval.

The Episealer® implant is made of biocompatible cobalt/chromium/molybdenum alloy. To enhance the osseointegration, the implant is coated with biocompatible hydroxyapatite onto an interlaying biocompatible pure titanium coating.

A previous study (S57685) showed that Episealer is a viable option for focal cartilage lesions of the distal femur not responding, or not eligible for, biological treatment options (eg. microfracturing). This device is a good solution when there are no alternative treatments, except prosthesis surgery, available.

The goal is to evaluate the efficacy, safety and performance of the Episealer® device in a larger sample size and on the long term.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with a focal cartilage lesion of the distal femur in which biological surgical methods have failed or are not eligible
* Minimal age 18 years (Preferred age group \>40 years)
* Suitable for implant, to be determined by analysis of MRI imaging. Suitability is set by the size and location of the lesion.
* Informed consent

Exclusion Criteria:

* Under age (\<18yrs)
* Active or recent (\<1 yr) septic arthritis of the involved knee
* Associated symptomatic untreated ligamentary or meniscal pathology in the involved knee
* (Severe) osteoarthritis in the involved or other compartments of the involved knee
* Severe osteoporosis
* MRI not possible (eg. due to pacemaker)
* Marked valgus- or varus alignment (\>6 degrees)
Bioequivalence Study of Levetiracetam Tablets, 750 mg of Dr. Reddy's Under Fed Conditions

The purpose of this study is to compare the single-dose relative bioavailability study of Levetiracetam Tablets 750 mg with Keppra® 750 mg Tablets under fed conditions.

This is an open-label, randomized, single-dose 2-way crossover relative bioavailability study in healthy adult male volunteers under fed conditions with a washout period of 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male volunteers, 18 to 55 years of age;
* Weighing at least 60 kg and within 15% of their ideal weights (Table of "Desirable Wights of Adults", Metropolitan Life Insurance Company, 1983);
* Medically healthy subjects with clinically normal laboratory profiles and ECGs as deemed by the principal investigator;
* Voluntarily consent to participate in the study

Exclusion Criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic, renal hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
* In addition, history or presence of:

  1. alcoholism or drug abuse within the past 2 years;
  2. hypersensitivity or idiosyncratic reaction to levetiracetam;
* Subjects who have been on an special diet (for whatever reason) during the 30 days prior to the first dose and throughout the study.
* Subjects who have made a donation (Standard donation amount or more) of blood or blood products (with the exception of plasma as noted below) within 56 days prior to the first dose.
* Subjects who have made a plasma donation within 7 days prior to the first dose.
* Subjects who have participated in another clinical trial within 30 days prior to the first dose.
* Subjects with hemoglobin less than 12.0 g/dL.
* Subjects who have participated in another clinical trial within 30 days prior to the first dose.
Bladder Instillations Versus Onabotulinumtoxin A for Treatment of Interstitial Cystitis/Bladder Pain Syndrome

Recognition of interstitial cystitis (IC)/bladder pain syndrome (BPS) is increasing. There is a dire need to develop effective treatment options for these patients as it manifests as more than a physical disease, affecting general and psychological health as well. Existing trials comparing varying bladder instillation formulations have not identified an optimal bladder instillation therapy, however existing studies support combined heparin and alkalinized lidocaine bladder instillation as an affordable and effective treatment for IC/BPS. Additionally, intradetrusor onabotulinumtoxinA injection has been well established for the treatment of overactive bladder (OAB), a constellation of symptoms similar to that of IC/BPS. OnabotulinumtoxinA has now come into the forefront for treatment of OAB due to its efficacy, safety profile, and absence of cognitive effects related to the previous mainstay anticholinergic treatment. While both bladder instillation and onabotulinumtoxinA therapy have been shown to be effective for treatment of IC/BPS, a direct comparison of these treatments has not been performed. We therefore designed a randomized controlled trial to compare the efficacy of heparin with alkalized local anesthetic bladder instillation versus intradetrusor onabotulinumtoxinA injection in treating IC/BPS symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Females ≥ 18 years of age
* O'Leary-Sant questionnaire score ≥ 6
* Ability to follow study instructions and complete all required follow-up

Exclusion Criteria:

* Contraindications and/or allergies to medications used
* Known alternative diagnosis explaining bladder pain symptoms
* Bladder instillation within the past 3 months
* Intradetrusor onabotulinumtoxinA injection within the past 6 months
* Use of ≥ 400 units of onabotulinumtoxinA in the last 3 months
* Inability or unwillingness to self-catheterize
* Post-void residual \> 200mL
* Concurrent procedural treatment (including hydrodistension, sacral neuromodulation)
* Current use of vaginal pessary/devices
* Untreated symptomatic prolapse \> pelvic organ prolapse quantification system (POP-Q) stage 2
* Females who are pregnant or planning a pregnancy during the study or who think that they may be pregnant at the start of the study and who are unwilling or unable to use a reliable form of contraception during the study
* Inability to speak/read English