cyrilzakka/clinical-trials huggingface dataset:
Substance Use Screening and Prevention for Adolescents in Pediatric Primary Care

This study is to test the effectiveness of integrating and adapting two National Institute on Drug Abuse (NIDA)-funded procedures for use in primary care pediatric clinics serving low-income youth: 1)the Youth Risk Index (YRI) and Transmissible Liability Index-Parent (TLI-P) nurse and/or research assistant-administered screening tools for high risk of substance use (SU) prior to high school and thus also for SUD and 2) the Family Check-Up (FCU) - a brief, family-based program to prevent SU/SUD with replicated efficacy.

This study is to test the effectiveness of integrating and adapting two National Institute on Drug Abuse (NIDA)-funded procedures for use in primary care pediatric clinics serving low-income youth: 1) the Youth Risk Index (YRI) and Transmissible Liability Index (TLI-P) nurse and/or research assistant-administered screening tools for high risk of substance use (SU) prior to high school and thus also for SUD and 2) the Family Check-Up (FCU) - a brief, family-based program to prevent SU/SUD with replicated efficacy.

The following three aims focus on evaluating and refining the adaptation of the YRI \& TLI-P program for primary-care use: 1) to replicate the effectiveness of the YRI \& TLI-P screening tool in terms of concurrent and predictive validity and the engagement rate in the FCU; 2) to identify and address challenges in implementing and integrating the YRI \& TLI-P/FCU prevention strategy within a primary care clinic serving urban, low-income youth; and 3) to test the effectiveness of the YRI \& TLI-P/FCU on emerging SU, sexual activity, and conduct problems, as well as the putative mediators of these outcomes including parenting and parental well-being.

Based on prior FCU efficacy studies, 500 dyads of parents and their 9 years, 9 months to 13 years, 11 months old children from low-income, ethnically diverse families will be recruited from two large primary care clinics in an urban community. The FCU will be delivered for two or three years to test impact of dosage. Participants will be followed-up one year after completing FCU to evaluate longitudinal outcomes of the Integrated YRI \& TLI-P/FCU .

Eligibility Criteria:
Inclusion Criteria:

* Child Aged 9 years, 9 months to 13 years, 11 months.
* A biological or adoptive parents or legal guardian with appropriate documentation with custody of the child.
* Either child or parent's score on screening assessment score must fall in elevated risk range.
* Child must be recipient of needs based Medicaid or family income must be at or below 150% Health and Human Services (HHS) Poverty Guidelines.

Exclusion Criteria:

* Inability to read English,
* Having moderate to severe mental disability (based on medical records),
* Child not accompanied by a biological or adoptive parent with legal custody or legal guardian with appropriate documentation
* Participant in the Early Steps Project
Weight Loss in Pre-Hypertensive Patients With Diastolic Dysfunction

The focus of this study is to observe the impact of weight loss in overweight individuals who have pre-hypertension (have a blood pressure reading of 121-139/81-89 mm Hg). The specific focus is to observe the difference in diastolic dysfunction (heart function) in these individuals at the beginning of the study and then again after 24-28 weeks. Diastolic dysfunction in this population indicates an increased risk of heart failure in the future. The aim of this study is to prevent or reduce the risk of heart failure in overweight individuals with pre-hypertension.

You will be enrolled in the study for 24-28 weeks and will be randomly assigned to one of two assigned group. One group of subjects (Intervention group) will receive information on Heart healthy diet, lifestyle recommendations and diet and exercise counseling with a dietitian in order to achieve at least 7% weight loss. The other group will receive standard of care i.e., Information on Heart healthy diet at baseline visit (Standard of care group). The following is the time line of activities anticipated by the subject in each group. Both the groups will be screened at 3 different visits within 4 weeks to determine eligibility. If you are eligible they will be randomized to either be in Standard of care group or Intervention group. After randomization, the "Standard of care group" will come for Baseline and Final visit (24th week). The Intervention group will have 14 weekly visits with a nutritionist and 1 monthly visit, about 40-50 minutes each visit (total of 15) in 24- 28 week time frame. The second monthly session will be the final assessment visit. Both the groups will have a Baseline Assessment and a Final Assessment visit which will last about 3 hours.

Eligibility Criteria:
Inclusion Criteria:

* Adults age ≥ 21 years
* BMI ≥30
* Individuals with diagnosis pre-hypertension at the time of screening, defined as either a blood pressure measurement of 130-139/85-89 mm Hg
* Echocardiographic EF \>50%
* Echocardiographic evidence of diastolic dysfunction;

Exclusion Criteria:

* Patients receiving antihypertensive medications
* Patients receiving diabetic medication
Effects of a Transitional Palliative Care Model on Patients With End-stage Renal Failure

Primary aim:

1. To compare the effects of customary care and an interventional Home-based Palliative Renal Program (HBPRP) for ESRF patients
2. To compare the effects of customary care and Home-based Palliative Program (HBPP) for ESRF patients

   Secondary aim:
3. To explore the lived experiences of patients with ESRF. Hypothesis The transitional renal palliative care model is associated with decreased in unscheduled hospital readmission, reduce length of stay as well as improved quality of life for patients with end-stage renal failure.

Objectives

Related to the primary aim:

1. Are there differences in healthcare utilization between the ESRF patients in the customary care group and those in the HBPRP group; in the HBPRP group and HBPP group?
2. Are there differences in evaluated health outcomes (functional status, symptom intensity, and satisfaction with care) between the customary care group and the HBPRP group ; in the HBPRP group and HBPP group?
3. Are there differences in perceived health outcomes (quality of life, caregiver burden) between the customary care group and the HBPRP group; in the HBPRP group and HBPP group?

   Related to the secondary aim:
4. How are the lived experiences compared and contrasted between the customary care group and the HBPRP group; in the HBPRP group and HBPP group?

Eligibility Criteria:
Inclusion Criteria:

* Patient with chronic kidney disease and diabetic mellitus with Creatinine ≥350 milli mole (uM) or those without diabetic mellitus with Creatinine ≥450 milli mole (uM) who refused renal replacement therapy (RRT);
* Patient not suitable for long term renal replacement therapy (RRT) after assessment by renal team (e.g. multiple co morbidities, poor functional status and social support)
* Identified as ESRF patient eligible for palliative care without prior renal replacement therapy
* Ability to speak Cantonese
* Living within the hospital service area
* Ability to be contacted by phone

Exclusion Criteria:

* Discharged to nursing home or other institution
* Inability to communicate
* Cognitive impairment, mini mental stage examination (MMSE) \< 20
* Diagnosed with severe psychiatric disorders such as schizophrenia and bipolar disorder
Study of Fluoxetine in Autism

The purpose of this study is to assess the effect of fluoxetine orally dissolving tablets (ODT) on the repetitive behaviors core domain in children and adolescents with Autistic Disorder. The study will also investigate the effect of fluoxetine on the improvement of symptoms and the effects on daily living of the patient's family.


Eligibility Criteria:
Inclusion Criteria:

* Meets DSM-IV criteria for autistic disorder, .
* CYBOCS-PDD score of at least 10 at screening.

Exclusion Criteria:

* Diagnosis of Asperger Syndrome or Pervasive Developmental Disorder Not Otherwise Specified, Rett Syndrome, Childhood Disintegrative Disorder.
* Patients planning to commence cognitive behaviour therapy during the period of the study or those who have begun cognitive behaviour therapy within 8 weeks prior to enrolment.
* Patients who are currently taking fluoxetine or who have previously taken it are not eligible for the study.

Other protocol-defined Inclusion/Exclusion criteria may apply.
Trial of GVHD Prophylasxis With PTCy or Thymoglobulin in Unrelated SCT

Purpose There is a growing evidence of high efficacy of post-transplantation cyclophocphomide (PTCy)-based GVHD prophylaxis in haploidentical and matched related and unrelated bone marrow transplantation. There is limitted, but growing data on safety and efficacy of this prophylaxis in unrelated and peripheral blood stem cell transplantations. Use of PTCy in chronic myeloproliferative neoplasms and myelodisplatic syndrome is of particular interest. On the one hand, PTCy could reduce the incidence of chronic GVHD and long-term bormidity. On the other hand, there is a concern, that PTCy can increase the incidence of graft failures in this group of patients. Currently published data indicate that low-dose Thymoglobulin-based prophylaxis is the most promissing compatitor in terms of acute and chronic GVHD control. So there is a rationale to randomize Thymoglobulin and PTCy as GVHD prophilaxis. Pre-transplant assesment of moratlity (PAM)-index will be used as the strata for randomization, as it is the paramter that takes into account the most important factors effecting survival. The conditioning regimen and the other two components of GVHD prophylaxis (mycophenolate mofetil and tacrolimus) will be identical in the two arms of the study.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have an indication for allogeneic hematopoietic stem cell transplantation
* Diagnosis: Chronic myeloid leukemia Myelodysplastic Syndromes Myeloprolipherative neoplsm unclassified Atypical chronic myelogenous leukemia
* Signed informed consent
* Patients with 10/10 HLA-matched unrelated donor available. The donor and recipient must be identical by the following genetic loci: HLA-A, HLA-B, HLA-Cw, HLA-DRB1, and HLA-DQB1. Mismatches in these loci are not allowed.
* Peripheral blood stem cells as graft source
* No second tumors
* No prior history of Thymoglobulin exposure or no history of anaphylactic shock after Thymoglobulin administration
* No severe concurrent illness

Exclusion Criteria:

* Moderate or severe cardiac dysfunction, left ventricular ejection fraction \<50%
* Moderate or severe decrease in pulmonary function, FEV1 \<70% or DLCO\<70% of predicted
* Respiratory distress \>grade I
* Severe organ dysfunction: AST or ALT \>5 upper normal limits, bilirubin \>1.5 upper normal limits, creatinine \>2 upper normal limits
* Creatinine clearance \< 60 mL/min
* Uncontrolled bacterial or fungal infection at the time of enrollment
* Requirement for vasopressor support at the time of enrollment
* Karnofsky index \<30%
* Pregnancy
* Somatic or psychiatric disorder making the patient unable to sign informed consent
A Trial of HRS-5041-103 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer

To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of 5041-103 in Subjects with Metastatic Castration-resistant Prostate Cancer.


Eligibility Criteria:
IInclusion Criteria

1. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
2. Adequate bone marrow and other vital organ functions
3. Adequate liver function tests
4. Metastatic Castration-resistant Prostate Cancer

Exclusion Criteria

1. Plan to receive any other anti-tumor therapy during the study.
2. Receipt of any chemotherapy, targeted therapy, immunotherapy, live/attenuated vaccination, radiotherapy or surgery within 4 weeks prior to the first dosing of this study.
3. Uncontrolled hypertension (systolic blood pressure \[SBP\] \> 150 mmHg and/or diastolic blood pressure \[DBP\] \> 100 mmHg with regular anti-hypertension therapy).
4. Factors that may affect the oral administration of the IP (swallow difficulty, chronic diarrhea, and bowel obstruction, etc.), or active gastrointestinal (GI) disease or other disease which may affect the absorption, distribution, metabolism, or elimination of IP.
5. Known history of drug allergies, specific allergies (such as asthma, urticaria, eczema, etc.).
6. Active heart disease within 6 months prior to the first dosing of this study.
7. Medical history of other malignant tumor within 5 years prior to dosing.
8. Positive hepatitis B virus (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV-Ab), or syphilis or severe infections which need treatment.
Pharmacokinetic Evaluation of Moxifloxacin Administered Intravenously and Orally in Healthy Volunteers Who Have Had a Gastric Bypass

Roux-and-Y gastric bypass is one of the most common forms of bariatric surgery; due to a reduction in size of the stomach and intestine, the available surface area for the absorption of oral drugs is strongly decreased. This may lead to a reduced bioavailability resulting in a reduced efficacy of the drug. However, in literature there is no information available about the impact of bariatric surgery on the pharmacokinetics of moxifloxacin. This protocol evaluates the moxifloxacin plasma levels, the variability between subjects and the absolute bioavailability, after oral administration of 400 mg moxifloxacin in healthy volunteers who have had a gastric bypass at least 6 months ago and who now have a stable body weight.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers who have had a gastric bypass at least 6 months ago and whose body weight has not changed more than 5% during the last 3 months
* Age between 18 and 60 years old
* Able to give informed consent

Exclusion Criteria:

* Other forms of bariatric surgery (Scopinaro and Mason/Sleeve) before gastric bypass surgery
* Hypersensitivity to moxifloxacin, other quinolones or to any of the excipients
* Pregnancy and lactation
* Creatinine clearance \< 80 ml/min
* Transaminases \> 2x the upper limit of normal (AST/ALT)
* Impaired liver function (Child Pugh C)
* Fasting glycaemia \> 125mg/dl
* Epilepsy
* Patients with a history of tendon disease/disorder (especially Achilles tendon rupture) related to quinolone treatment
* Patients with the following heart disorders:

  * Electrolyte disturbance, particularly an uncorrected hypokalaemia
  * Clinically relevant bradycardia
  * Clinically relevant heart failure with reduced left-ventricular ejection fraction
  * Previous history of symptomatic arrhythmias
* Congenital or documented acquired QT prolongation or concurrently use of drugs that prolong the QT interval:

  * anti-arrhythmics (Classes IA and III)
  * neuroleptics
  * tricyclic antidepressants
  * antimicrobials (e.g. sparfloxacin, intravenous erythromycin, pentamidine, antimalarials particularly halofantrine)
  * some antihistamines (e.g. terfenadine, astemizole, mizolastine)
  * cisapride, intravenous vincamine, bepridil and diphemanil
* No normal thyroid function
* All clinically significant disorders that can interfere with the study
Genetic Data Collection in Adult Participants to Identify Genetic Variants of Known Importance in Non-alcoholic Steatohepatitis (NASH)

Collection of clinical and genetic data to help identify individuals that carry genetic variants of known importance in Non-alcoholic Steatohepatitis (NASH)


Eligibility Criteria:
Key Inclusion Criteria:

One or more of the following:

1. A prior diagnosis of NASH with a Clinical Research Network (CRN) fibrosis score of F1 to F4 based on liver biopsy
2. Evidence of NAFLD by imaging or liver histology as described in the protocol

   * The possible imaging modalities to assess historic evidence of NAFLD may be based on thresholds as described in the protocol
3. Known high-risk genotype for HSD17B13 (T/T or T/TA) and/or PNPLA3 (C/G,or G/G)
4. A clinical suspicion of NASH based on presence of 2 or more elements of the metabolic syndrome defined by:

   1. Waistline that measures \>35 inches (89 centimeters) for women or \>40 inches (102 centimeters) for men
   2. Historic fasting triglycerides \>150 mg/dL within the prior 6 months
   3. Historic fasting HDL cholesterol \<40 mg/dL in men or \<50 mg/dL in women, or on cholesterol-lowering medication within the prior 6 months
   4. Historic fasting blood glucose \>100 mg/dL or on diabetes medication within the prior 6 months
   5. Historic blood pressure \>130/85 mmHg, or on anti-hypertensive medication within the prior 6 months

Key Exclusion Criteria:

1. Known history or clinical evidence of drug abuse, within the 12 months before screening. Drug abuse is defined as compulsive, repetitive, and/or chronic use of drugs or other substances with problems related to their use and/or where stopping or a reduction in dose will lead to withdrawal symptoms.
2. Excessive alcohol intake for ≥3 months during the past year prior to screening (\>3 units/day for males and \>2 units/day for females is generally considered excessive (unit: 1 glass of wine \[approximately 125 mL\]=1 measure of spirits \[approximately 1 fluid ounce\]=½ pint of beer \[approximately 284 mL\]).
3. History of liver transplant, current placement on a liver transplant list, or Model for End-stage Liver Disease (MELD) score \>12.
4. History of viral and resolved hepatitis or human immunodeficiency virus (HIV).
5. Any malignancy within the past 5 years except for basal cell or squamous epithelial cell carcinoma of the skin, or any carcinoma in situ.

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Preoperative Single-dose Steroid Application for the Treatment of Nausea and Vomiting After Thyroid Surgery

The study is to compare the postoperative recovery, as determined by postoperative nausea and vomiting (PONV) after preoperative application of single-dose dexamethasone versus saline in patients undergoing partial or total thyroidectomy.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Planned partial or total thyroidectomy

Exclusion Criteria:

* History of adverse effects to dexamethasone or propyleneglycol or di-natrium-EDTA
* Patients with chronic pain
* Necessity for opioids-application in the postoperative course
* Not possible administration of a cervical block (0.5% bupivacaine at a dose of 20ml)
* Patients with Diabetes mellitus
* Pregnancy (test in young women)
* Glaucoma
* Patients who received antiemetic therapy within 48h before surgery
* Patients with acute pain requiring painkillers others than paracetamol or more than single dose NSAR treatment within 48h before surgery
* Use of psychotropic drugs
* Incompliant patients
* Preoperatively high suspicion of malignancy
* Re-operations
Hemodynamics for Equi-MAC Anesthesia

The aim of this study is to compare the peripheral perfusion index values produced by equi-MAC of sevoflurane and desflurane in patients undergoing single-agent inhalation anesthesia.

Ether derivative anesthetics, including sevoflurane and desflurane, have direct activity on vascular tissue and both are vasodilators. However, there has been no direct comparison of vasodilative effect between sevoflurane and desflurane in vivo in humans. Peripheral perfusion index derived from photoplethysmographic waveform reflects peripheral vasomotor tone. Therefore, the purpose of this study is to compare the peripheral perfusion index values produced by sevoflurane and desflurane at equipotent concentration in patients undergoing single-agent inhalation anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* patients aged between 19 and 65 yr
* patients with American Society of Anesthesiologists physical status classification I or II
* patients scheduled for elective arthroscopic knee surgery under general anesthesia
* patients obtaining written informed consent

Exclusion Criteria:

* patients with a history of any disease associated with the autonomic nervous system
* patients receiving any medication affecting the sympathetic or parasympathetic nervous systems
* patients with cardiac arrhythmia, diabetes mellitus, and alcohol or drug abuse
* pregnant women
Long Term Effects of Erythrocyte Lysis

In this prospective observational trial, participants with chronic hemolysis will be assessed with echocardiogram for elevated tricuspid jet velocity and other evidence of pulmonary hypertension. Participants will have laboratory studies evaluating: severity of hemolysis, splenic function, inflammation, endothelial dysfunction, and hypercoagulability. There will be 3 main categories of participants enrolled in this study: (1) pediatric participants with severe sickle cell disease (SCD) (HbSS, HbS/β° thalassemia ) who are not receiving treatment (e.g., hydroxyurea or chronic transfusions); (2) pediatric participants with other forms of SCD or severe SCD (HbSS, HbS/β° thalassemia) patients being treated with hydroxyurea or chronic transfusions; and (3) pediatric and adult participants with other non-sickling hematological disorders.

1. The study will investigate the relationship between tricuspid regurgitation jet velocity (TRV) and intravascular hemolysis, as measured by serum lactate dehydrogenase (LDH), in untreated children with severe sickle cell disease (HbSS or Hb S/β°-thalassemia)
2. The Study will estimate the prevalence of elevated TRV (≥ 2.5 m/s) in untreated children with severe sickle cell disease (HbSS or Hb S/β°-thalassemia), as measured by echocardiography.

Secondary objectives for this study include the following:

1. To estimate the prevalence of elevated TRV in children with severe sickle cell disease (HbSS or Hb S/β°-thalassemia) receiving hydroxyurea or chronic transfusion therapy.
2. To estimate the prevalence of elevated TRV in children with other forms of hemolytic anemia, including other sickling disorders (such as HbSC or HbS/β+-thalassemia) and non-sickling hemolytic anemia (such as hereditary spherocytosis).
3. To estimate the prevalence of elevated TRV in adults with non-sickling hemolytic anemia, with or without splenic function.
4. To investigate the association between TRV and splenic function
5. To investigate the associations between TRV and laboratory parameters of inflammation and hypercoagulability, such as white blood cell count, platelet count, serum N-terminal pro-brain natriuretic peptide (NT-proBNP),endothelial dysfunction, and other markers of hemolysis (bilirubin, plasma free hemoglobin, haptoglobin, etc.)
6. To evaluate genetic determinants of elevated TRV in children and adults with hemolytic anemia.
7. To investigate changes in TRV and hemolysis over time using serial measurements 2 ± 0.5 years after initial enrollment testing.

Eligibility Criteria:
Inclusion Criteria:

1. Established Diagnosis of Hemolysis

   * Sickle Cell Disease (e.g., HbSS, HbS/β-thalassemia, HbSC)
   * Other conditions with hemolysis (e.g., RBC membranopathies, enzymopathies, unstable hemoglobinopathies, PNH)
2. Age

   * SCD participants: 5 years of age up to 19th birthday
   * All other participants: 5 years of age and up (no age limit)

Exclusion Criteria:

1. Previous cardiac surgery
2. Known left ventricle dysfunction (i.e. shortening fraction \< 28%)
3. Known right sided congenital heart defect such as atrial septal defect or pulmonary valve stenosis