cyrilzakka/clinical-trials huggingface dataset:
Effect of Activity Modification and Exercises in Young Adolescents With Osgood Schlatter Disease.

The purpose of this study is to investigate the effect of activity modification, exercises and a gradual return to sport in adolescents (age 10-14) with Osgood Schlatter disease. The primary outcome is self-reported recovery on a 7-point Likert scale at 3 months. Secondary endpoints include 4 and 8 weeks and 6 and 12 months after inclusion into the project. The adolescents will be recruited from primary schools, general practitioners and through online advertising on Facebook.


Eligibility Criteria:
Inclusion Criteria:

* 10-14 years of age
* Pain at tuberositas patellae during two or more of the following activities: Sitting with a bent knee, squatting, running, jumping or stair ambulation
* Pain during palpation of tuberositas patellae
* Knee pain for 6 weeks or more

Exclusion Criteria:

* Other knee conditions that may manifest as anterior knee pain (Patellofemoral pain, iliotibial band syndrome, sinding-larson-johanson disease).
* Previous surgery
* Pain from the hip or back that interferes with activities of daily living.
* Habitual patella luxations
* Clinical suspicion of meniscal lesion
Computer Aided Diagnosis of Colorectal Neoplasms During Colonoscopic Examination

An NBI-based diagnosis requires training and experience. We are developing a system of computerized image recognition, which can detect possible NBI features of polyps, and provide a more objective diagnosis, which allows nonexpert endoscopists to achieve a high diagnostic accuracy.


Eligibility Criteria:
Inclusion Criteria:

the same as colonoscopy

Exclusion Criteria:

the same as colonoscopy
Efficacy of Preparation in Self-Hypnosis by Anchoring Versus Conversational Hypnosis, Used Alone or Combined, in Patients Undergoing Breast Macrobiopsies

The incidence of breast cancer and its mortality are reduced thanks in particular to early detection.

Often performed after a screening test, stereotactic macrobiopsies are used to characterize abnormalities detected on mammography. This anxiety-inducing and painful examination leads to significant physiological and psychological modifications for these women who logically apprehend the realization of this act.

Faced with this observation, investigators wondered what could be done to improve the experience of the patients during this examination.

Investigators were interested in hypnosis because its effectiveness as a complementary practice has been validated by numerous studies with benefits on pain and stress management.

However, today, there are no convincing results confirming which hypnosis method would be the best to manage patients' anxiety and pain during this examination.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 or over,
* referred to the medical imaging department of Saint-Joseph hospital for breast macrobiopsy,
* naive of any hypnosis,
* having given free, informed and written consent,
* being affiliated to a social security scheme or beneficiary of such scheme

Exclusion Criteria:

* having a major hearing loss,
* suffering from identified mental or psychotic disorders,
* not understanding the French language,
* having already had hypnosis practices,
* having an ongoing pregnancy,
* being the subject of a safeguard measure
Genetic Susceptibility for Bronchopulmonary Dysplasia in Preterm Infants

Despite considerable obstetric and neonatal advances in the care of very low birth weight (VLBW) neonates, bronchopulmonary dysplasia (BPD) continues to occur among 20 to 40% of surviving infants, and new ways for combatting this disease must be found. BPD appears to result from arrested lung development, but its etiology has not yet been fully established. Besides the role of the exposure of the immature lung to injurious factors in the development of BPD, a genetic susceptibility for BPD in preterm infants was recently evidenced. Taking advantage of new genomic technologies, the objective of the investigators' project is to identify predisposing human genetic variants through:

1. a genome-wide association (GWA) study in VLBW neonates,
2. a candidate-gene association study, including selection of single nucleotide polymorphisms (SNPs) found in (a) and
3. functional studies of any SNP found to be convincingly associated with BPD in (a) and (b).


Eligibility Criteria:
Inclusion Criteria:

* Gestational age \< 28 weeks
* Inborn birth
* Prophylactic administration of surfactant in the delivery room
* Written informed consent obtained from parents

Exclusion Criteria:

* Gestational age of 28 weeks or more
* Outborn birth
* No prophylactic administration of surfactant in the delivery room
* Congenital malformation
* Absence of written informed consent obtained from parents
Bioavailability and Pharmacokinetics of BI 135585 XX Administered as Tablet With and Without Food

The objective of this study is to investigate the effect of food on the relative bioavailability of a 50 mg BI 135585 XX tablet.


Eligibility Criteria:
Inclusion criteria:

- healthy male subjects

Exclusion criteria:

- Any relevant deviation from healthy conditions
DRUG RELEASING BALL vs. PHARMACOACTIVE STENT IN LARGE VESSELS: MORPHOLOGICAL ANALYSIS AND FUNCTION VASOMOTOR (DEBORA STUDY) IN LARGE VESSELS: MORPHOLOGICAL ANALYSIS AND FUNCTION VASOMOTOR (DEBORA STUDY)

Randomized, controlled, open and multicenter study that analyzes the vasomotor function 8 months after use of the drug-eluting balloon (DCB) vs. drug-eluting stent (DES) in vessels ≥ 3.5 mm

Randomized, controlled, open and multicenter study that analyzes the vasomotor function 8 months after use of the drug-eluting balloon (DCB) vs. drug-eluting stent (DES) in vessels ≥ 3.5 mm

Eligibility Criteria:
Inclusion Criteria:

Patients who meet all of the following conditions are included.

* Patients aged ≥ 18 years and;
* Patients with chronic coronary syndrome, acute coronary syndrome without ST segment elevation or acute coronary syndrome with elevation ST segment in non-culprit lesions 48 hours after the event and;
* Patients with de novo lesions in vessels ≥ 3.5 mm without calcification significant no visible thrombus and;
* Patients who have been informed of the characteristics of the study and have provided their written informed consent.

Exclusion Criteria:

Patients who meet at least one of the following conditions are excluded:

* Patients with any contraindication for the administration of acetylcholine (ACh) or nitroglycerin (NTG).
* Patients with a history of coronary vasospasm or spontaneous dissection of the coronary artery.
* Patients with significant medical, surgical or psychiatric condition that would affect the safety of the subject or influence the outcome of the study according to the doctor's opinion.
* Patients who received a combination of DES and DCB in the same vessel
* Patients with glomerular filtration rate \<30 ml/min/ 1.73 m2
* Patients with body mass index \>35 (may affect the evaluation qualitative diameter of the coronary artery).
* Patients with symptomatic congestive heart failure.
* Patients with significant autoimmune inflammatory conditions and patients taking immunomodulatory medications (including methotrexate, cyclosporine, steroids).
* Patients with heart transplant.
* Patients with anemia (Hb \<12 g/dL in men and \<10 g/dL in women).
* Patients, women of childbearing age with a positive pregnancy test.
* Pregnant female patients.
* Patients included in other clinical trials with active follow-up.
A Study of Tirzepatide (LY3298176) in Chinese Participants With Type 2 Diabetes

The main purpose of this study is to compare the effect of the addition of tirzepatide or placebo to titrated basal insulin on glycemic control in Chinese participants with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Have type 2 diabetes mellitus (T2DM)
* Have HbA1c ≥7.0% (53 mmol/mol) to ≤11% (97 mmol/mol)
* Have been treated with insulin glargine (U100) once daily alone, or in combination with metformin with or without SGLT-2i ≥90 days
* Have a body mass index (BMI) ≥23 kilograms per meter squared (kg/m²)

Exclusion Criteria:

* Have type 1 diabetes mellitus (T1DM)
* Have a history of chronic or acute pancreatitis
* Have proliferative diabetic retinopathy or diabetic macular edema or nonproliferative diabetic retinopathy that requires acute treatment
* Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
* Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months
* Have a history of diabetic ketoacidosis or hyperosmolar state/coma within the 6 months
* Have acute myocardial infarction, or cerebrovascular accident (stroke) or hospitalization due to congestive heart failure (CHF) in the past 2 months
* Have a serum calcitonin level of ≥35 ng/L, as determined by central laboratory
* Have acute or chronic hepatitis, signs, and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level \>3.0 times the upper limit of normal (ULN), as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial.
Corona And Manual Professions

This observational study will follow the chiropractors and naprapaths in Sweden to study how work environment, health, and economy is changing during the COVID-19 pandemic.

All manual therapists that are members of a professional organization in Sweden will be invited to participate. The study started in November 2020 with follow-ups planned after 3,6 and 12 months.

All data-collection is taking place with digital questionnaires.

There are three main areas of interest:

1. Work environment (knowledge about viral contageon, protection, availability of protective measures, disturbances in care for patients)
2. Health (physical and psychological, how many caught the virus?)
3. Economy (income, costs, turnover)

Eligibility Criteria:
Inclusion Criteria:

* Chiropractor or naprapath working in Sweden
* clinically active
* belonging to a professional organization

Exclusion Criteria:
Prognostic Factors for Surgical Management of Large Hypertensive Basal Ganglionic Haemorrhage

The aim of this study is to present current and comprehensive recommendations for surgical treatment of this hematoma and to determine the factors that may improve the survival rate

Spontaneous intracerebral hemorrhage is a common, mostly deadly stroke subtype and accounts for 10% to 15% of all strokes.

It's associated with a higher mortality rate (44% after 30 days) than either ischemic stroke or subarachnoid hemorrhage Up to 75% of the long term survivors are often suffering significant disability and only 12% to 39% of the survivors have favourable neurological functions recovered Rapid diagnosis and attentive management of patients is crucial because early deterioration is common Neurosurgical treatment for ICH has been discussed in recent multicentric studies, but no definitive answer of its utility has emerged.

Improved surgical techniques , neuroimaging, neuroanesthesia and perioperative monitoring and care have all led to improved outcomes from surgery

Eligibility Criteria:
Inclusion Criteria:

* 1) patients aged between 15 and 60 years old ( elderly people\>60 years were excluded since their strokes weren't routinely examined by CT scan in the emergency ward, however, in children\<15 years old was due mostly to vascular malformations 2) CT scan showed basal ganglionic haemorrhage, with or without intraventricular extension within 24 hr post ictus 3) hematoma volume was 30 ml or above 4) Glasgow Coma Scale scores more than or equal 5 and stable vital signs

Exclusion Criteria:

* 1) intracerebral hemorrhage was caused by secondary factors e.g ( vascular malformations or head trauma) 2) GCS less than 5 or multiple intracranial hemorrhage 3) associated visceral disease e.g hepatic or renal or clotting disorder 4) patients with preexisting neurological deficit e.g previous intracerebral hemorrhage or infarction
AZD0837 Extended Release (ER) Japan Study

This phase I study will evaluate safety and tolerability after repeated doses of AZD0837.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male Japanese subject aged between 20 to 45 years inclusive

Exclusion Criteria:

* Acute illness (including ongoing or history of liver disease), trauma or surgical procedures within two weeks before Visit 1 or pre first dose in Visit 2
* Intake of another investigational drug within 4 months before Visit 1 or pre first dose in Visit 2
* Blood donation and/or sampling in excess of 200 mL of whole blood within the preceding 4 weeks, 400 mL of whole blood within the preceding 12 weeks and/or 1200 mL of whole blood within the preceding 12 months, before Visit 1 or pre first dose in Visit 2
Evaluation of Safety of Low Level Laser Device Treatment in Chronic Wounds

This is a randomized, double blind, placebo-controlled study to evaluate the safety of the low level laser MC-8XL device treatment in subjects with an unsuccessfully treated Diabetic Foot Ulcer (DFU) that has been present for at least 3 months.

Eligible subjects will be randomized to either Treatment group or Control group, following which, treatment of each subject will be provided by a qualified nurse at the clinic or in the home setting, everyday for up to 16 weeks.

Study assessments and adverse events monitoring will be also performed throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Provide signed and dated Informed Consent Form
* Willing to comply with all study procedures and be available for the duration of the study
* Male or female, aged 18 to 90
* Having a DFU of at least 3 months duration that had not improved after prior standard wound treatments
* HbA1c of \<11.0
* Size of wounds: 1-10 cm2
* Having DFU of grades 2 or 3 according to Wagner's classification

Exclusion Criteria:

* Immeasurable wounds or wounds that are unsuited to this laser treatment (usually due to the wound's location, e.g. in the area between the toes).
* Uncontrolled Diabetes defined as an HbA1c of \> 11.0
* Arterial insufficiency, Doppler vascular assessment (if needed- Ankle Brachial Index (ABI) \< 0.6)
* Osteomyelitis in the bone.
* Photosensitivity
* Pregnancy
* Presence of any suspicious pre-cancerous or cancerous lesions, or having cancer.
* Being on medications that are immunosuppressive, may affect peripheral blood flow or may affect normal wound healing.
* Being on medications that might cause photosensitivity.
* Participation in any other clinical trial testing a device or drug.
Thalidomide in Treating Patients With Refractory or Resistant Epithelial Ovarian Cancer

RATIONALE: Drugs such as thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating women who have epithelial ovarian cancer that has not responded to previous therapy.

OBJECTIVES:

* Determine the time to progression of disease in patients with platinum-refractory or resistant ovarian epithelial carcinoma treated with thalidomide.
* Evaluate the quality of life of patients treated with this regimen.

OUTLINE: Patients receive oral thalidomide once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then every 4 weeks.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 9-15 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed ovarian epithelial carcinoma
* Platinum-refractory or resistant disease

  * At least 1 prior non-platinum chemotherapy agent required
* Prior bilateral salpingo-oophorectomy and hysterectomy required
* Bidimensionally measurable disease OR CA-125 greater than 100 units/mm3

PATIENT CHARACTERISTICS:

Age:

* Over 18

Performance status:

* Karnofsky 70-100%

Life expectancy:

* More than 3 months

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin normal
* AST no greater than 2.5 times upper limit of normal (ULN)

Renal:

* Creatinine no greater than 1.5 times ULN OR
* Creatinine clearance at least 50 mL/min

Other:

* No other prior malignancy except non-melanoma skin cancer unless curatively treated with no evidence of disease within the past 5 years and at low risk for recurrence
* No other clinical circumstances that would preclude study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* At least 4 weeks since prior biologic therapy and recovered
* No prior thalidomide

Chemotherapy:

* See Disease Characteristics
* At least 4 weeks since prior cytotoxic therapy and recovered

Endocrine therapy:

* At least 4 weeks since prior hormonal therapy and recovered

Radiotherapy:

* At least 4 weeks since prior radiotherapy

Surgery:

* See Disease Characteristics
* At least 4 weeks since prior major surgery
Pilot Study Evaluating the Safety and Efficacy of a Patient-Specific Enteroatmospheric Fistula Isolation and Management Device Independent of Negative Pressure Wound Therapy

This study aims to assess the efficacy of a custom fitted device designed to isolate enteroatmospheric fistulas effluent independent of negative pressure wound therapy and to evaluate the effects on the device related to dressing changes, time required for dressing changes, management costs, and the ease of use.


Eligibility Criteria:
Inclusion Criteria:

* Stable condition, as determined by attending physician
* Has enteroatmospheric fistula (EAF) in the setting of open abdomen
* EAF is determined to require surgical resolution

Exclusion Criteria:

* Unstable condition, as determined by attending physician
* Significant risk of complication
A Single Ascending Dose Study of Safety and Tolerability of STA363 Compared to Placebo in 15 Patients With Chronic Discogenic Low Back Pain

A phase I, randomized, double-blinded, placebo-controlled, single ascending dose study to investigate the safety, local tolerability and transformation of nucleus pulposus following intradiscal injection of STA363 or placebo in patients with discogenic low back pain.

15 patients will participate in either of 3 dose groups, each comprising 5 patients:

* Group 1: STA363 dose 1 (3 patients) or placebo (2 patients)
* Group 2: STA363 dose 2 (3 patients) or placebo (2 patients)
* Group 3: STA363 dose 3 (3 patients) or placebo (2 patients)


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent prior to any study-related procedures
* Chronic discogenic low back pain present for more than 6 months prior to the screening visit
* 20 to 60 years of age at the screening visit
* Insufficient response to at least 6 months of non-operative treatment (analgesics and/or antiinflammatory medication, physiotherapy etc.)
* A single lumbar disc appropriate for treatment at L3/4 to L5/S1, based on clinical evaluation by the investigator
* Pfirrmann grade II-III
* Ability to understand the written and verbal information about the study

Exclusion Criteria:

* Treatment with any investigational product within 3 months prior to the screening visit
* More than one painful intervertebral disc
* A painful intervertebral disc above L3/4 level
* Current infection or prior history of spinal infection (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection
* Previous lumbar spine surgery
* Previous disc invasive treatment procedures at the affected level(s) (e.g., intradiscal electrothermal therapy, intradiscal radiofrequency thermocoagulation)
* Pfirrmann grade I, IV and V
* Evidence of prior lumbar vertebral body fracture or trauma
* Need for spinal decompression assessed by the investigator
* Presence of disc extrusion or sequestration
* Patients previously included in the study
* Patients suffering from psychosomatic pain in the opinion of the investigator
* Referred leg pain of compressive origin
* Known alcohol and/or drug abuse
* Severe intercurrent illness (e.g. rheumatic disease or chronic pain syndrome) or concomitant treatment (e.g. immunosuppressive drugs), which, in the opinion of the investigator, may put the patient at risk when participating in the study, or affect the patient's ability to take part in the study
* Clinically significant abnormalities in clinical chemistry or haematology parameters as assessed by the investigator
* Pregnant or lactating females or intention to become pregnant within the study period
* Known allergy to any of the components of the drug product or placebo
* Known opioid allergy or intolerance
* Patients requiring treatment with warfarin or other anticoagulant therapy
* Unwillingness to refrain from treatment with non-steroidal anti-inflammatory drugs (NSAIDs) within 5 days before the planned study treatment
* Body weight less than 50 kg
A Study of LY3461767 in Healthy Participants

The main purpose of this study in healthy participants is to learn more about the safety of LY3461767 and any side effects that might be associated with it. The study will also measure how much LY3461767 gets into the bloodstream and how long it takes the body to get rid of it. For each participant, the study will last about 11 weeks, including screening.


Eligibility Criteria:
Inclusion Criteria:

* Are healthy males, or females of non-child-bearing potential
* Have a body mass index of 18 to 35 kilograms per square meter (kg/m²)
* Have clinical laboratory tests within normal ranges as judged by investigator
* Have pulse rate and blood pressure within normal ranges as judged by investigator

Exclusion Criteria:

* Have Troponin I results above the upper reference limit, and judged to be clinically significant by the investigator, at screening
* Have an abnormality in the 12-lead electrocardiogram (ECG) at screening
* Have a significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders
* Regularly use known drugs of abuse
* Have donated blood of more than 450 milliliters (mL), or have participated in a clinical study that required similar blood volume collected within the past 3 months
* Have an average weekly alcohol intake that exceeds 7 units per week or are unwilling to stop alcohol consumption as required during the study
* Smoke more than 10 cigarettes per day
* Are current or former smokers with 30-pack-year smoking history
* Have a diagnosis or history of any malignancy
* Have not had appropriate cancer screening, in accordance with country specific guidance
Single-center Ambispective Observational Study on the Role of Magnetic Resonance Imaging (MRI) in the Evaluation of Patient Affected by Hepatic Metastases of Carcinoma of the Colorectal Cancer (CRC).

This study wants to evaluate the use of MRI in the managemente of mCRC with liver only metastases.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years;
* Histological diagnosis of colorectal cancer;
* Presence of liver metastases in the staging exams (chest-abdomen CT with contrast medium or PET-CT with 18-FDG);
* At least one measurable liver lesion according to RECIST 1.1 criteria;
* Adequate organ and marrow function.

Exclusion Criteria:

* Age \< 18 years;
* Inability to undergo MRI;
* Major contraindications to liver surgery;
* No written informed consent.