cyrilzakka/clinical-trials huggingface dataset:
Electrocardiograph Changes and Holter Abnormalities in Children With Predialytic Chronic Kidney Disease

CKD is a strong risk factor for cardiovascular disease and mortality , As in adults, cardiovascular disease occurs in some children with CKD before they reach ESRD as well as after

This work aims to study the electrophysiological changes in cardiovascular system in children with predialytic CKD. ECG is important in detection of cardiac rhythm abnormalities, cardiac conduction defects and detection of myocardial ischemia

Eligibility Criteria:
Inclusion Criteria:

Age 1 to 15 year children with predialytic chronic kidney disease GFR.\>15 ml\\min per 1.73m2 , stages 1, 2, 3, 4 according to (KDOQI stages).

Exclusion Criteria:

* Age \>15 year On regular dialysis GFR\<15 ml\\min per 1.73m2, Stage 5 according to (KDOQI stages). Children with known cardiovascular disease or known arrhythmia Patients on the potential medication affecting ECG result as B-blocker, antipsychotics , antidepressant
506U78 in Treating Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Clinical trial to study the effectiveness of 506U78 in treating patients who have relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma.

OBJECTIVES:

* Provide an investigational agent, 506U78, to physicians for the management of individual patients with relapsed or refractory T-cell acute lymphoblastic (lymphocytic) leukemia or T-cell lymphoblastic lymphoma who are not candidates for entry onto ongoing research clinical trials of higher priority.
* Evaluate the toxic effects of 506U78 when administered as a 2 hour IV infusion 3 days a week every 21 days in these patients.
* Evaluate the antitumor efficacy of this regimen in terms of rate of complete responses in these patients.

OUTLINE: Patients receive 506U78 over 2 hours on days 1, 3, and 5. Treatment repeats every 21 days for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression.

Patients are followed every 3 months for one year and then every 6 months until death.

PROJECTED ACCRUAL: A minimum of 25 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed relapsed or refractory T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma

  * Tumor cells should exhibit phenotypic characteristics of these diseases
* No CNS involvement requiring intrathecal or craniospinal radiotherapy
* Must not be eligible for Intergroup, Cooperative Group, or local research studies of higher priority

PATIENT CHARACTERISTICS:

Age:

* 16 and over

Performance status:

* ECOG 0-3 OR
* Karnofsky 40-100%

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Bilirubin no greater than 2.0 mg/dL

Renal:

* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 50 mL/min

Other:

* No neuropathy grade 2 or higher
* No history of significant neurological toxicity (grade 2 or greater) associated with prior chemotherapy or radiotherapy
* No active seizure disorder
* No active infection
* No other active concurrent malignancy except curatively treated basal cell carcinoma or carcinoma in situ of the cervix
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Prior bone marrow transplantation allowed
* No concurrent allogeneic bone marrow transplantation

Chemotherapy:

* At least 3 weeks since prior chemotherapy (6 weeks for nitrosourea or mitomycin) and recovered
* No prior 506U78

Endocrine therapy:

* No concurrent systemic steroid therapy

Radiotherapy:

* See Disease Characteristics
* Prior radiotherapy allowed

Surgery:

* Not specified

Other:

* No other concurrent investigational therapy
* No concurrent treatment for seizures
Dose Ranging Study of Recombinant Human Insulin-like Growth Factor I in Children With Hyperinsulinism

OBJECTIVES:

I. Determine the dose of recombinant human insulin-like growth factor I that minimizes or decreases the need for exogenous glucose support without causing hypoglycemia.

PROTOCOL OUTLINE: This is a dose escalation study. Patients receive an escalating dose of recombinant human insulin-like growth factor I (IGF-I). IGF-I is given subcutaneously twice a day. The dose of IGF-I is increased each day for 4 days. Glucose is administered intravenously, when necessary, to prevent hypoglycemia.

Following the study treatment patients resume prior medication and may undergo surgery.

Completion date provided represents the completion date of the grant per OOPD records

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

* Diagnosis of hyperinsulinism (i.e., evidence of fasting hypoglycemia with inadequate suppression of insulin, normal pituitary and adrenal function, and increased insulin action)
* Intractable hypoglycemia (i.e., persistent IV glucose requirement for maintaining glucose levels greater than 60 mg/dL)
* Failed standard treatment regimen of diazoxide, octreotide, and frequent feedings to control hypoglycemia
* No other major medical problems
Use of Psychologist-administered Cognitive Behavioral Therapy (CBT) or Self-administered CBT for the Treatment of Anxiety and/or Depression in Inflammatory Bowel Disease (IBD)

This is a prospective, single center, randomized treatment study to assess if anxiety and depression in participants with IBD can be improved with CBT compared to those treated with SKY.

This is a prospective, single center, randomized treatment study, where participants will be screened for anxiety and depression in an inflammatory bowel disease (Crohn's disease and ulcerative colitis) population using the Generalized Anxiety Disorder (GAD) questionnaire and the Patient Health Questionnaire (PHQ). Participants with GAD scores of ≥8 will be considered to have anxiety and those with a PHQ score of ≥10 will be considered to have depression. All participants with screening questionnaire scores positive for anxiety or depression will be randomized to treatment with either cognitive behavioral therapy (CBT) with a clinical psychologist (virtual visits) or CBT using a book written for IBD patients. The GAD and PHQ surveys will be repeated post treatment at weeks 6, 12 and 24. The primary objective of this study is to assess for an improvement in GAD and PHQ scores among subjects treated with CBT comparing 2 modalities of CBT. The secondary objectives are to assess for improvements in health-related quality of life, based on short IBD Questionnaire scores; assess for improvement in pain scores, based on the Brief Pain Inventory Short Form; and assess for improvement in fatigue scores based on the FACIT-Fatigue Scale, among subjects with poor scores at baseline following treatment with CBT.

Eligibility Criteria:
Inclusion Criteria:

* verified inflammatory bowel disease (Crohn's disease and ulcerative colitis)
* IBD patients on a stable treatment regimen with no evidence of active intestinal inflammation based on either normal c-reactive protein and/or fecal calprotectin, imaging studies, or endoscopy who meet the criteria for anxiety or depression based on the screening questionnaires
* subjects who have been on stable doses of anxiety and/or depression medications (defined as no dose adjustment in the prior 12 weeks) at the screening visit who meet the criteria for anxiety and/or depression based on screening questionnaires and are willing to stay on the same dose of these medications throughout the study duration
* may meet the criteria for both anxiety and depression and cohort assignment will be based on the survey with the highest scores suggesting more severe symptoms

Exclusion Criteria:

* declines to participate for the full duration of the study
* evidence of active intestinal inflammation based on an elevated c-reactive protein and/or fecal calprotectin, imaging studies or endoscopy
* non-English speaker
* any subject who expresses suicidal ideation or has severe mental illness as they will be taken to the emergency room for urgent psychiatric care
Proof-of-concept for the Aldosterone Synthase Inhibitor LCI699 in Patients With Primary Hyperaldosteronism

The purpose of this study is to determine if LCI699, thorough reductions in aldosterone, can lower BP in patients with Primary hyperaldosteronism.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary hyperaldosteronism (PH) within the last 3 years, either with or without an aldosterone producing adenoma (APA).
* Hypertension at screening

Exclusion Criteria:

* Persistent hypokalemia
* Renal impairment
* Significant hepatic disease
* Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of any drug substance

Other protocol-defined inclusion/exclusion criteria may apply
Safety and Efficacy Study of Lenvatinib Combined With VIC-1911 for the Treatment of Advanced HCC

This study is a single-arm, open-label trial to clarify the safety and efficacy of the combined treatment of lenvatinib and VIC-1911 in patients with advanced liver cancer.

This study is a single-arm, open-label trial to clarify the safety and efficacy of the combined treatment of lenvatinib and VIC-1911 in patients with advanced liver cancer.

Purpose of the Study:

To observe and determine the safety and efficacy of lenvatinib combined with VIC-1911 in the treatment of patients with advanced liver cancer.

Sample Size:

According to the research plan, the administration of the study medication is divided into two stages, with 3 patients enrolled in the accelerated titration phase and 12 patients in the expansion phase.

Study Subjects:

Patients with advanced HCC

Eligibility Criteria:
Inclusion Criteria:

* Gender unrestricted, age 18-75 years;
* HCC conforms to AASLD or EASL clinical diagnostic standards;
* HCC Barcelona Clinic Liver Cancer (BCLC) staging is C, with at least one measurable tumor in the liver (longest diameter ≥1cm);
* Liver function Child-Pugh Class A or Class B with a score of 7;
* ECOG score of 0-1;
* Platelet count ≥60×10\^9/L, PT time prolongation ≤6 seconds.

Exclusion Criteria:

* Irreversible coagulation dysfunction, with obvious bleeding tendency;
* Patients who need long-term anticoagulation or antiplatelet treatment and cannot stop medication;
* Patients with unstable or active ulcers, gastrointestinal bleeding;
* Patients with untreated heart disease or poorly controlled hypertension as judged by the researcher;
* Severe dysfunction of important organs, such as severe cardiopulmonary dysfunction;
* Patients with hepatic encephalopathy or refractory ascites requiring treatment;
* Human Immunodeficiency Virus (HIV) infection;
* Active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection (activity defined as viral load \> 20000 IU/mL), or HBV, HCV positive patients who refuse to accept standardized antiviral treatment;
* Inability to swallow oral medication.
* Gastrointestinal diseases that may affect the absorption or tolerance of the study medication.
* History of corneal epithelial cysts or other causes of blurred vision, or medical abnormalities found in ophthalmic screening.
* Known allergy to VIC-1911 or its components.
* Within 4 weeks before the study, radiotherapy or interventional therapy for the disease under study was performed;
* Other concurrent antitumor treatments;
* The researcher assesses that the patient cannot or is unwilling to comply with the requirements of the study protocol.
Effect of Sulfur Thermal Water on Circulating H2S Levels and Markers of Bone Metabolism in Osteopenic Subjects.

The aim of the study is to investigate whether inhalation treatment with high-sulfide waters from some spas (referred to as "thermal waters"), performed for 12 consecutive days, is able to change circulating H2S levels and alter bone metabolism. Identifying a clear correlation between circulating levels of H2S and sulfur water administration, as well as a potential anabolic effect on bone, would set the stage for new studies that could have important clinical implications for promoting health and preventing osteoporosis


Eligibility Criteria:
Inclusion Criteria:

* post-menopausal women with a diagnosis of osteopenia

Exclusion Criteria:

* concurrent muscoloskeletal conditions or chronic pharmacological treatment interfering with bone metabolism
Safety and Effectiveness of the ATC System in the Treatment of Acute PE

This study is a prospective, single-arm, interventional, multicenter study to evaluate the safety and effectiveness of the ATC System in subjects with acute pulmonary embolism (PE).


Eligibility Criteria:
Inclusion Criteria:

1. Patient is ≥ 18 and ≤ 90 years old
2. Clinical signs and symptoms consistent with acute PE for \< 14 days
3. CTA evidence of proximal PE
4. RV/LV ratio \> 0.9
5. Systolic BP ≥90 mmHg without the need for vasopressors
6. Stable heart rate (HR) \< 130 BPM prior to procedure
7. Patient is deemed medically eligible for interventional procedure(s), per investigator guidelines and clinical judgment
8. Subject or legally authorized representative (LAR) is willing and able to provide written informed consent prior to receiving any non-standard of care protocol specific procedures

Exclusion Criteria:

1. Prior PE \< 180 days from index procedure
2. Thrombolytic use \< 30 days prior to baseline CTA
3. Pulmonary hypertension with peak pulmonary artery systolic pressure (PASP) \>70 mmHg by right heart catheterization
4. FiO2 requirement \>40% or \>6 LPM to keep oxygen saturation \>90%
5. Hematocrit \<28%
6. Platelets count \<100,000/µL
7. Serum creatinine \>1.8 mg/dL
8. International normalized ratio (INR) \>3
9. Major trauma injury severity score (ISS) \>15 prior to screening assessment
10. Presence of intracardiac lead in right ventricle or atrium placed within 6 months prior to screening assessment
11. Cardiovascular or pulmonary surgery within 7 days of index procedure
12. Actively progressing cancer treated by chemotherapeutics
13. Known bleeding diathesis or coagulation disorder
14. Left bundle branch block
15. History of severe or chronic pulmonary arterial hypertension
16. History of chronic left heart disease with left ventricular ejection fraction ≤ 30%
17. History of decompensated heart failure
18. History of underlying lung disease that is oxygen dependent
19. History of chest irradiation
20. History of heparin-induced thrombocytopenia (HIT)
21. Contraindication to systemic or therapeutic doses of anticoagulants
22. Known anaphylactic reaction to radiographic contrast agents that cannot be pretreated
23. Imaging evidence or other evidence that suggest, in the opinion of the investigator, the Subject is not appropriate for aspiration thrombectomy intervention
24. Life expectancy \<90 days, as determined by investigator such as stage 4 cancer, frailty or severe COVID infections
25. Female who is pregnant or nursing
26. Current participation in another investigational drug or device treatment study.
Block and Erector Comparative Study Between Costotransverse Spinae Plane Block in Patients Undergoing Thoracotomy

A thoracotomy requires a very painful incision, involving multiple muscle layers, rib resection and continuous motion as the patient breathes. Treatment of acute post thoracotomy pain is particularly important not only to keep the patient comfortable but also to minimize pulmonary complications

Though epidural analgesia was once considered as the gold standard for post-thoracotomy pain management, it is not recommended for pain control after thoracotomy surgery because it is associated with high potential risks of dural puncture, nerve lesions, epidural hematoma and hypotension(4). Thoracic paravertebral block (TPVB) and intercostal nerve block are well described and recognized techniques for postoperative analgesia following thoracic surgeries, such as thoracotomy and mastectomy


Eligibility Criteria:
Inclusion Criteria:

* • Age from 18 to 75 years old.

  * Both sexes.
  * American Society of Anesthesiologists (ASA) physical status I-II-III.
  * Patient undergoing unilateral thoracotomy surgery.

Exclusion Criteria:

* • BMI more than 30 kg/m2.

  * Patients who are taking analgesics for chronic illness or have a history of substance abuse.
  * Patients who are unable to describe their postoperative pain (e.g., language barrier or neuropsychiatric disorder).
  * Patients with a history of coagulopathy.
  * Severe heart diseases.
  * Hepatic or renal insufficiency.
  * Infection at the site of infiltration
Food Security and Nutrition in Rural Cambodia

The project is a three arm randomized control trial in rural Cambodia designed to evaluate the impact of homestead food production (home gardens) with and without fish ponds versus control on household food security, dietary intake of women and youngest child, biochemical nutritional status of women, and household livelihoods over a 22 month period. Baseline and end line surveys will be conducted that involve questionnaires and a blood sample.


Eligibility Criteria:
Inclusion Criteria:

* Must be represented by a woman.
* Must fall within the "poor" category in terms of community wealth rankings.
* Must have access to land (including homestead) for agriculture cultivation.
* Must have sufficient access to labor to undertake the homestead production activities.
* Must have a keen interest in participating in this action.
* Must have a least one child less than five years of age (in 80% of the target households).
* Have suitable land for pond and preferably own a small pond

In addition village model farm owners will:

* Have at least 1,200 square meters of land that can be used to establish the model farm;
* Have some disposable income to invest in the model farm for fencing and land preparation;
* Be productive, open to new ideas and willing to provide assistance to other households in the village;
* Be able and willing to maintain the VMF throughout the year;
* Commit to providing inputs and marketing support to group members at least during the project.

Exclusion Criteria:

* None, only that they don't meet the inclusion criteria
Somatropin Therapy In Children Born Preterm But Appropriate For Gestational Age

Safety and efficacy of Somatropin will be evaluated in short children born with a list weight below 1500 g and that did not catch up to normal height at the age of 4.


Eligibility Criteria:
Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:

* Prepubertal caucasian boys between 4 and 10 years of age and girls between 4 and 9 years of age.
* Girls: Tanner stage 1 breast development
* Boys: Testis volume \<= 3ml
* Tanner stage 1 pubic hair development (to exclude confounding effect of adrenarche on growth velocity, insulin sensitivity and body composition).
* (In case of any signs or symptoms of gonadal puberty a GnRH-Test must decide if the subject is still pubertal.)
* Height \<=-2 SD for chronological age (Brandt/Reinken).
* Growth velocity SDS below 0 SD for chronological age (Brandt/Reinken based on 12+/- 3 months observation period before screening).
* Premature born defined as \<=1500 g birth weight.
* GH sufficiency (GH level \> 7 ug/l following any routine GH stimulation test).
* Written informed consent of both parents (legal guardians) and oral/written consent of subject due to age specific information.

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the trial:

* Other endocrine diseases except for well substituted hypothyroidism.
* Severe chronic diseases or medication that might influence linear growth or insulin sensitivity (e.g. Glucocorticoids).
* Positive GAD and IA-2 antibodies (for type 1 diabetes).
* History of malignancy
* Children who meet all of the following 4 criteria:
* actual body height \< -2,5 SDS (Brandt/Reinken) and parent adjusted target height \< -1 SDS (Hermanussen and Cole, 2003)
* length and/or body weight retardations adjusted to gestational age at birth \< -2,0 SDS (Lawrence et al., 1989, Voigt et al., 1996)
* children with chronological age \> = 4 years and
* growth velocity \< 0 SDS during the last year before inclusion.
* Chromosomal aberrations or syndromes.
* Suspected non-compliance or impossibility to follow the two or three year treatment schedule, respectively (e.g. social implications).
* Severe hemiparesis and severe CNS defects
* Retinopathia \> third degree or laser treatment as newborns.
* Participation in any other clinical trial during active treatment phase.
* Other severe acute or chronic medical or psychiatric condition or clinically relevant laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
Stress and Clinical Reasoning in Medical Students

Solving a problem in ambulatory setting may contain peripheral stress due to socio-evaluative stressors (patient's expectations about explanations) and task contingent stress due to time pressure, the necessity to take into account patient's mood, to deal with uncertainty of their own data collection and with complex clinical situations. In France, excepted for family medicine, undergraduate medical students and residents are currently not trained to perform consultations and are never exposed to ambulatory patients during training. The investigators postulate that this lack of practice may generate a significant state of stress during the first consultations and consequently modify or even impair clinical reasoning.

The primary objective of this study is to compare subjective and physiological levels of acute stress in ambulatory versus hospitalization setting in medical students confronted to a real patient with a diagnostic problem.

Measures: The French version of the Anxiety Spielberger test is administered just before and after each problem solving session.

Cortisol salivary samples are taken before and after each problem solving session. Salivary cortisol levels have been shown to be correlated to stressful situations and some personality traits but with some difference according to gender.

Cognitive appraisal (threat/challenge) is assessed before and after the tasks by the ratio of primary appraisal to secondary appraisal according to Tomaka et al.

Participants and Method:

Year 6 medical students who attend a one-month full-time course in an Internal Medicine Department are eligible.

Since no consultations in the ambulatory setting are currently structured for medical students, the following adjustments have been done within the internal medicine consultation department, with the approval of the department director:

* the consultation duration has been increased (1 hour instead of 30 minutes)
* during the first 30 minutes, consultation is performed by the participant
* during the following 30 minutes, the patient is examined by his/her own physician.
* The consent of the patient has been obtained by phone (prior to the consultation).

Eligibility Criteria:
Inclusion Criteria:

* Year 6 medical students who attend a one-month full-time course in an Internal Medicine Department

Exclusion Criteria:

* Student who repeats his year 6 of medicine
* Student treated with corticoids