cyrilzakka/clinical-trials huggingface dataset:
Impact of Hyperoxia and Involvement of the Immune System in Diving Accident

The impact of oxygen therapy in many pathologies has been subject of recent work, arguing both favourable and harmful effects. Consequently, one can wonder about the influence of hyperoxic gas mixture during diving on the genesis of decompression sickness, but also about the systematic application of normobaric and hyperbaric oxygen in case of proven decompression sickness.

In mammals, normoxic concentrations have been redefined at 20-100 mbars at the extracellular level and below 10 mbars in the mitochondria.

Under hyperbaric conditions, most of the oxygen being dissolved in blood plasma, a state of hyperoxia is established which escapes the usual delivery and regulation system represented by red blood cells.

The results of our team's previous work suggest a specific effect of diving on the levels of circulating mitochondrial DNA (mtDNA), suggesting cellular destruction linked to hyperoxia/hyperbaria. In fact, our studies, carried out on both animals and human divers, have shown that diving accident leads to an increase in mtDNA levels and an immune reaction through the mobilisation of leukocytes.

The main objective of this study is to compare the influence of oxygen partial pressure levels on the evolution of clinical and biological variables during hyperbaric oxygen therapy sessions in healthy versus injured divers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subject with no contraindications to diving OR patient admitted to the hospital for suspicion of a diving accident OR patient admitted to the hospital for hyperbaric oxygen therapy

Exclusion Criteria:

* Contraindication to diving or contraindication to hyperbaric oxygen therapy
A Study to Evaluate the Effect of Fimasartan on Pharmacokinetics, and the Safety of Digoxin in Healthy Male Volunteers

The purpose of this study is to evaluate the effect of fimasartan on pharmacokinetics, and the safety of digoxin.


Eligibility Criteria:
Inclusion Criteria:

* age: 20 - 40 years
* sex: male
* body weight: greater than 55 kg
* written informed consent

Exclusion Criteria:

* known allergy to Fimasartan and digoxin
* existing cardiac or hematological diseases
* existing hepatic and renal diseases
* existing gastrointestinal diseases
* acute or chronic diseases which could affect drug absorption or metabolism history of any serious psychological disorder
* positive drug or alcohol screening
* smokers of 10 or more cigarettes per day 3 month ago
* participation in a clinical trial during the last 2 months prior to the start of the study
Obstructive Sleep Apnea Patients Treated With Mandibular Advancement Device

The purpose of this study is to evaluate efficacy of mandibular advancement device (MAD). on treating obstructive sleep apneas, symptoms, Apnea/Hypopnea Index (QHI) and the Respiratory Arousal Index (AHI/REI) and peripheral capillary oxygen saturation (SpO2) Range, PULSE in patients with mild to moderate obstructive sleep apnea/hypopnea syndrome, and evaluating potential dental side effects

The primary oral appliance (OA) used in obstructive sleep apnea (OSA) treatment is the mandibular advancement device (MAD). MADs may be either an over-the-counter stock device or customized for individual patients. MADs come in various designs and materials, but most comprise upper and lower splints mounted over the dentition as either a 1-piece monoblock or a 2-piece biblock Connectors or blocks relate the upper and lower splints in a biblock to protrude the mandible in a forward position during sleep.

Although the efficacy of oral appliances has been proved, the relationship to the nature of airway enlargement in patients with OSA has not yet been clearly demonstrated.

The aim of this study is therefore to evaluate the efficacy mandibular repositioning appliance reduces sleep apneas symptoms with mild to moderate obstructive sleep apnea . Secondary outcomes include the dental side effects of such appliance. At baseline and after 4 month's treatment, This study will be conducted to estimate frequency of OSA on population sample from Erbil study, in addition trying to evaluate the efficiency of MAD on some patients who are diagnosed with OSA.

Eligibility Criteria:
Inclusion Criteria:

1. sample will be taken from Kurdish population in Erbil city.
2. Obstructive sleep apnea, apnea-hypopnea index of \<30 with excessive daytime sleepiness

Exclusion Criteria:

1. People with problems in nasal part of airway.
2. People with cleft lip and palate
3. Patient who did tonsillectomy and / or other pharyngeal operations.
4. People who take any kind of sleep medication.
5. Temporomandibular Disorders.
6. People with periodontal disease.
7. Less than 8 teeth/ arch.
Bilateral Knee Osteoarthritis: Intra-articular Injection of Filtered Autologous Adipose Tissue Versus Placebo

The purpose of the study is to assess the radiological and clinical outcomes comparing two different treatments (Filtered Autologous Adipose Tissue versus Placebo) in patients affecting bilateral knee osteoarthritis.

After be randomized, every patient will be treated in both legs, one leg with Adipose Tissue and the other one with Placebo.

All patients who meet the inclusion criteria and giving written informed consent will be randomized.

Every patient will be treated with a single injection of Filtered Autologous Adipose Tissue in one knee and single injection of Placebo in the other, based on the randomization.

After the treatment patients will be followed up to 24 months.

Eligibility Criteria:
Inclusion Criteria:

1. bilateral degenerative chondropathy of the knees showing at least a grade 2-3 kellgren-lawrence classification (absence of severe osteoarthritis)
2. An overall Pain subscale score of the Western Ontario and McMaster Universities Osteoarthritis Index between a value of 9 and 19.
3. Failure, intended as the persistence of symptomatology, after at least one conservative treatment cycle (pharmacological, physiotherapeutic or infiltrative treatment);
4. Ability and informed consent of patients to actively participate in the rehabilitation protocol and clinical and radiological follow-up;

Exclusion Criteria:

1. Patients incapable of understanding and wanting;
2. Diagnosis of leukaemia, known presence of metastatic malignant cells, ongoing or planned chemotherapy;
3. Diagnosis of rheumatoid arthritis, Reiter's syndrome, psoriatic arthritis, gout, ankylosing spondylitis or arthritis resulting from another inflammatory disease; infection with human immunodeficiency virus (HIV), viral hepatitis; chondrocalcinosis;
4. Patients with uncontrolled diabetes mellitus;
5. Patients with uncontrolled thyroid metabolic disorders;
6. Patients who abuse alcoholic beverages, drugs or medicines;
7. Patients with misalignment of the lower limbs above 10 degrees;
8. Body Mass Index \> 40;
9. Pregnant or lactating state or intention to become pregnant during the period of participation in the study.
10. Patients with a history of trauma or intra-articular infiltration of therapeutic substances in the 6 months prior to screening.
11. Patients who have had knee surgery in the 12 months prior to screening.
12. Patients with insufficient abdominal adipose tissue, assessed by the investigator
Microbial and Environmental Factors Associated with Polyps Development in Familial Adenomatous Polyposis (MicrobEnvironment in FAP)

Familial adenomatous polyposis (FAP) is an autosomal dominant inherited disorder linked to a mutation in the APC gene, associated with the development of multiple colonic and duodenal adenomas, which in 100% of cases progress to colorectal cancer (CRC) if left untreated. Management of affected patients is usually based on prophylactic total colectomy with or without rectal preservation, followed by regular endoscopic surveillance of the duodenum and rectum or ileal reservoir. However, there is considerable inter- and intra-familial variability in the rate of adenoma appearance and development for identical mutations. This strongly suggests the additional role of environmental factors. Recently, the gut microbiota has been identified as a co-factor of carcinogenesis in patients with FAP, but no prospective evaluation of the association between the incidence and severity of adenomatous proliferations and a microbiological signature has been studied, particularly at duodenal level in operated patient.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years
* Non-opposition obtained
* Prophylactic colectomy for at least 2 years in the context of APC-related familial adenomatous polyposis with ileorectal or ileoanal anastomosis
* Included in the national POLYPOSE database
* Regular endoscopic follow-up with upper and lower GI endoscopy at Hôpital Edouard Herriot or Hôpital de la Croix-Rousse
* Having performed at least 2 endoscopies as part of follow-up

Exclusion Criteria:

* Antibiotic therapy within 2 months prior to stool sampling
* Taking probiotics for less than 1 month
* Person deprived of liberty by judicial or administrative decision
A First in Human Trial Evaluating THB335 in Healthy Participants

This study is a double blind, randomized, placebo-controlled, Phase 1 study in two parts: single ascending doses and food effect (Part 1) and multiple ascending doses (Part 2).

THB335 is a highly potent and selective inhibitor of the receptor tyrosine kinase KIT that is expressed on mast cells.

The study will evaluate the safety, pharmacokinetics, pharmacodynamics, and food effect profile of THB335 administered orally in healthy participants.

Eligibility Criteria:
Inclusion Criteria:

* In good health, determined by no clinically significant findings from medical history, 12 lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations
* Males or females, of any race, between 18 and 65 years of age, inclusive.
* Participants must understand the nature of the study and must provide signed and dated written informed consent in accordance with local regulations before the conduct of any study related procedures
* Body weight of ≥ 50.0 kg for men and ≥ 45.0 kg for women and Body Mass Index (BMI) of 17.5-32.0 kg/m2 (inclusive) at Screening

Exclusion Criteria:

* Significant history or clinical manifestation of cancer or any metabolic, allergic, dermatological, hepatic, biliary, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
* Vaccinated within 14 days prior to Day -1 or intention to receive vaccination during the study
* A positive urine drug screen/alcohol breath test
* The participant currently smokes, vapes, or uses nicotine-containing products.
Investigation of Cardiopulmonary Parameters, Motor Development and Muscle Strength in DS With and Without CHD

Congenital heart diseases (CHD) are detected in 40-60% of individuals with Down syndrome (DS) and increase the risk of developmental delay in the presence of syndromes. The aim of the study was to compare cardiopulmonary parameters, gross motor development and hand grip strength in DS children with and without CHD. Demographic variables, cardiopulmonary parameters and echocardiographic values were recorded. Gross motor development was evaluated with Gross Motor Function Measure (GMFM-88). Hand grip strength was measured with the Baseline Pneumatic Bulb Dynamometer.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Down syndrome as a result of genetic analysis,
* For the congenital heart disease group; undergoing cardiac surgery at least 6 months before the evaluation, diagnosed as CHD by a pediatric cardiologist based on echocardiographic findings,
* For the group without congenital heart disease, patients who have not undergone cardiac surgery, are asymptomatic with a septal defect smaller than 4-5 mm, are expected to close, and are hemodynamically normal by a pediatric cardiologist,
* Children whose families were informed about the study and gave written consent to participate in the study were included in the study.

Exclusion Criteria:

* Having another genetic abnormality other than Down syndrome,
* undergoing surgery other than cardiac surgery,
* Having an orthopedic or neurological problem,
* Respiratory support,
* With atlantoaxial instability,
* Children with hematological disease were not included in the study.
Prasugrel 5mg Versus High Dose Clopidogrel in Clopidogrel Resistant Patients Aged ≥75 Years and/or Weighing <60 kg Post Percutaneous Coronary Intervention (PCI)

The use of dual antiplatelet therapy is considered standard of care in patients post percutaneous coronary intervention (PCI) with stenting. However, a significant proportion of patients is considered clopidogrel resistant and this resistance is shown to be accompanied by future adverse events. The aim of the study is to define in consecutive patients with acute coronary syndrome (ACS) undergoing PCI, those aged\>75years and/or weighted\<60 Kg with high on-clopidogrel platelet reactivity (Platelet Reactivity Units-PRU≥235) as estimated 24 hours post PCI with the VerifyNow assay. Those patients will be randomized after informed concent in 1:1 fashion to prasugrel 5 mg or clopidogrel 150mg daily. Platelet reactivity will be assessed at day 15 and then treatment crossover will be performed. At day 30 platelet reactivity will be determined as well.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old
2. Patients having PCI with stenting 24 hours prior randomization, meeting the following criteria :

   * Acute coronary syndrome (unstable angina or myocardial infarction)
   * TIMI risk score\>2
3. Platelet reactivity in PRU ≥235 24 hours post-PCI
4. Age≥75 years and/or weight\<60 Kg

4. Informed consent obtained in writing

Exclusion Criteria:

* A history of bleeding diathesis
* Chronic oral anticoagulation treatment
* Contraindications to antiplatelet therapy
* Known platelet function disorders
* PCI or coronary artery bypass surgery \< 3 months
* Unsuccessful PCI (residual stenosis \> 30% or flow \< Thrombolysis in myocardial infarction flow 3)
* Planned staged PCI in the next 30 days
* Hemodynamic instability
* hemodialysis
* Creatinine clearance \<25 ml/min
* inability to give informed consent
* High likelihood of being unavailable for the Day 30
* History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.
* Other bleeding diathesis, or considered by investigator to be at high risk for bleeding on longterm antiplatelet therapy.
* Any previous history of ischemic stroke, transient ischemic attack, intracranial hemorrhage or disease (neoplasm, arteriovenous malformation, aneurysm).
* Thrombocytopenia (\<100.000 / μL) at randomization
* Anaemia (Hct \<30%) at randomization
* Polycythaemia (Hct \> 52%) at randomization
* Periprocedural IIb/IIIa inhibitor administration
Children's Healthy Living Community Randomized Trial

The goal is to build social/cultural, political/economic, and physical/built environments that will promote active play and intake of healthy food to prevent young child obesity in the Pacific Region. Our methods will support local culture in order to achieve this goal in these remote, underserved native populations. CHL will engage the community, and focus on capacity building and sustainable environmental change.

The focus of the CHL community-based program is to promote healthy eating and to increase physical activity. In order to demonstrate effectiveness, the investigators will recruit and measure children in six communities selected in each of our jurisdictions in the Pacific. These represent intervention communities, comparison communities, and temporal communities.

The specific objectives of our study are as follows.

Objective. Decrease the prevalence of young child overweight and obesity; and its functional outcomes (decrease acanthosis nigricans, and increase sleep; increase moderate to vigorous physical activity and decrease sedentary behavior (screen time); increase healthy eating (fruit and vegetable intake, water intake; decrease sweetened beverage intake), through community-based primary prevention environmental interventions in the Pacific region.

Objective. Measure 2-8-year-old children at baseline and 24 months in selected communities to track behaviors and anthropometry that indicate healthy eating, physical activity, and BMI.

Objective. Measure 2-8 year old children at 78 months in the selected communities to determine the long term effect of the CHL program.

Eligibility Criteria:
Inclusion Criteria:

* Community criteria

Four (4) to six (6) communities in each of five (5) jurisdictions (Alaska, American Samoa, Commonwealth of Northern Mariana Islands, Guam \& Hawai'i) chosen for community randomized program based on:

* 2000 U.S. Census criteria

  * \>1000 people
  * \>25% Native population,
  * \>10% under 5y
* CHL Staff Community Evaluation

  * Sufficient Head Start/preschool, kindergarten
  * Children live \& go to school in area
  * Separation between communities to allow testing
  * Access for CHL
  * Sufficient community cohesiveness
  * Sufficient settings for program (community centers, parks, stores...)
* Child criteria • 2-10 years of age

Exclusion Criteria:

* Child criteria

  * Known orthopedic, psychological or neurologic impairments that prevent physical activity
  * Presence or history of any metabolic or chronic health problems known to affect intermediary metabolism (e.g. untreated thyroid disease, cancer, hepatic disease, renal disease, diabetes, cardiovascular disease, hypertension)
  * Irregular use of prescription or over-the-counter medications known to affect appetite, food intake or intermediary metabolism (e.g. appetite suppressants, lithium, antidepressants, etc.)
Success Rate Evaluation of Miniature Pulpotomy With MTA in Primary Molars

The purpose of this study is to evaluate the clinical and radiographic success rate of Miniature pulpotomy with Mineral Trioxide Aggregate (MTA) in primary molars.


Eligibility Criteria:
Inclusion Criteria:

* healthy people(without any systemic disease)
* teeth :

  * no clinical or radiographic evidence of pulp degeneration
  * the possibility of proper restoration of the teeth

Exclusion Criteria:

* teeth :

  * excessive bleeding from the exposure site
  * internal root resorption
  * interradicular and/or periapical bone destruction
  * swelling or sinus tract
Abraxane in Patients With Visceral Metastases Dominant Metastatic Breast Cancer

Abraxane in patients with visceral metastases dominant metastatic breast cancer

A Prospective, Single-center, Open-Label, Phase II Study of Abraxane in patients with visceral metastases dominant metastatic breast cancer

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed metastatic breast cancer;
2. Radiologically or histologically confirmed visceral dominant metastases;
3. Patients who are expected to acquire benefit from chemotherapy: ER and/or PR positive patients who developed resistance after prior endocrine therapy; HER2+ patients who experienced disease progression on prior target therapy and are not suitable for subsequent target therapy; mTNBC patients who relapsed after platinum therapy;
4. At least one measurable disease according to the response evaluation criteria in solid tumor (RECIST 1.1);
5. Patients who received paclitaxol in metastatic setting should be proven effective to prior paclitaxol based regimen and disease progressed after at least 3 months from the last administration of paclitaxol; those who received paclitaxel as neoadjuvant/adjuvant therapy can be enrolled if disease relapsed after at least 6 months from the completion of neoadjuvant/adjuvant chemotherapy. Patients who received docetaxol have no limitation for enrollment;
6. Eastern Cooperative Oncology Group performance (ECOG) status of 0-1;
7. All patients enrolled are required to have adequate hematologic, hepatic, and renal function;
8. Life expectancy longer than 12 weeks;
9. No medical history of serious cardiovascular, hepatic, respiratory or renal diseases;
10. Informed consent;
11. Patients with good compliance.

Exclusion Criteria:

1. Pregnant, lactating women or women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study;
2. Patients who are expected to acquire benefit from endocrine or target therapy;
3. Radiotherapy of axial bones within 4 weeks before enrollment or lack of recovery from prior radiotherapy;
4. Treatment with other experimental drug within 4 weeks before enrollment;
5. Patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. Radiotherapy should be completed within 4 weeks prior to enrollment;
6. Other active malignancies (including other hematologic malignancies) or other malignancies within the last 5 years, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia;
7. Patients with a history of symptomatic cardiovascular, hepatic, respiratory, renal , hematological, endocrinal, neurological or psychiatric diseases;
8. Uncontrolled serious infection.
A Pilot Study on the Effect of Vitamin D Treatment in Patients With Statin-Associated Myalgia

The purpose of this study is to measure the effect vitamin D has in alleviating muscle pain or aches that may be caused by taking certain medications for treating high cholesterol.

Participation in this study will consist of at least two study visits, expected to occur over a period of up to four weeks. Study-related medication will be provided at no cost to participants. Participants will receive either Vitamin D or placebo (sugar pill).

Eligibility Criteria:
Inclusion Criteria:

* Men and women who are between the ages of 18 and 88 years old
* A muscle symptom defined as any of the following: Myalgia (muscle aches with normal CK); Myopathy (muscle aches with increased CK up to 5 times above the upper limit of normal); or Myopathy for the purpose of further evaluation (muscle aches with increased CK up to 5 times the upper limit of normal)

Exclusion Criteria:

* Women who are pregnant, breastfeeding or planning to become pregnant
* Morbidly obese with a BMI \>40 kg/m2
* Travel to southern states, areas near the Equator, etc., or use of artificial tanning beds, such that study participants have increased sunlight/UV rays exposure in the past 30 days or at any point during the trial
* Currently (within the last 2 weeks) using any of the following supplements: Vitamin D-3 (Cholecalciferol) of more than 400 IU orally daily, which would not exclude typical multi-vitamin use; Vitamin D-2 (Ergocalciferol); Calcitriol; or Coenzyme Q10
* Documented to be hyperglycemic or laboratory results show hyperglycemia prior to randomization
* Renal dysfunction defined as glomerular filtration rate less than 60 mL/min.
* Documented to have parathyroid abnormalities or parathyroid hormone laboratory results show the study participant is outside of the normal limits