cyrilzakka/clinical-trials huggingface dataset:
Multicenter Study to Evaluate the Clinical and Cost Effectiveness of a Youth Culturally Adapted Therapy (YCMAP)

To evaluate the clinical and cost-effectiveness of a youth culturally adapted manual assisted therapy (YCMAP) in Pakistani Adolescents with a history of self-harm

Globally suicide is the second leading cause of death in young people 15-29 years of age. A recent review indicated that the reported suicide rates in South Asia are high compared to the global average. These figures are likely to be an under estimate since suicide data from many Low and Middle Income Countries (LMICs) is lacking. There is little official data on suicide from Pakistan, where suicide and self-harm remains as criminal act and socially, religiously condemned. However, there is accumulating evidence that both self-harm and suicide rates have been increasing in Pakistan.

This is the first RCT of a psychological intervention for self-harm in children and young people in Pakistan. It follows from the work of "Multicentre RCT to evaluate the clinical and cost effectiveness of culturally adapted manual assisted psychological intervention"(CMAP) trial currently taking place in adults who have self-harmed in Pakistan, by evaluating whether a similar intervention, adapted for children and adolescents, could be clinically and cost effective.

Eligibility Criteria:
Inclusion Criteria:

* Patients age 12-18 years presenting to the participating GPs, emergency departments or admitted after an episode of self-harm to the participating hospitals or self-referrals.
* History of recent self-harm. Recent self-harm is defined as self-harm occurring within the last 3 months (from the initial identification of a potential participant).
* Participants living within the catchment area of the participating practices and hospitals.
* Not needing inpatient psychiatric treatment.

Exclusion Criteria:

* Severe mental illness (such as Psychotic disorder) as Self-harm commonly co- occurs with other mental health difficulties.
* Conditions limiting engagement with assessment or intervention, including developmental and communication disorders, intellectual disabilities and autistic spectrum disorders.
* Temporary resident unlikely to be available for follow up.
Evaluation of the Impact of Within-hospital Trajectories of Patients Admitted in Intensive Care Units (ICU) From Emergency Departments

This multicenter cohort aims to assess the impact of within-hospital trajectories of patients admitted in intensive care units from emergency departments on vital prognosis of patients, duration of hospital stay and hospital costs.

As secondary objectives, the study will:

* assess the impact of clinical and demographic characteristics on hospital trajectories of patients.
* assess the impact of emergency units workload, beds availability in medical units and in intensive care units, and global hospital organisation on patients care trajectories.

The study will be performed in emergency departments and ICUs of university hospitals. 15 emergency departments and 36 ICUs of APHP (the public hospital system of the city of Paris) will be involved.

The study will assemble the data from 50,000 to 80,000 patients in total.

Eligible patients are admitted in ICUs between 01/01/2007 and 12/31/2011.

Extraction of the patients' data will be performed with processing software utilised in APHP, i.e. Healthcare Information System Program (PMSI, Urqual, Gilda...etc.).

Collected patients' data span the period from admission in emergency department or medical department unitl hospital discharge.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient directly admitted in ICU from emergency departments of APHP (the public hospital system of the city of Paris).
* Adult patient indirectly transferred to ICU from an hospitalization unit, initially admitted from an emergency department of APHP.

Exclusion Criteria:

* Patient transferred from APHP toward an external hospital, outside APHP, before being admitted in an ICU.
Chronic Adaptations to Spinal Flexion Exposure

An experimental study, which will aim to compare changes of trunk mechanical properties and neuromuscular control following spinal flexion exposure in crane operators and control subjects.

Our experimental study will include 40 participants, more specifically 15 crane operators and 15 control subjects. All participants will complete a 60-min protocol of intermittent trunk flexion. Measurements of trunk mechanical properties and neuromuscular control will be performed prior to and following the 60-min protocol.

Eligibility Criteria:
Inclusion Criteria:

* Crane operators: employed as crane operators for more than 3 years
* Occupational workers with a predominantly non static job (e.g. combination of sitting and standing)

Exclusion Criteria:

* History of chronic low back pain
* Episode of acute low back pain
* Hip injury in the past six months
* Previous spine, pelvis or hip surgery
* Hypermobility, diagnosed with the Beighton score
* High intensity resistance training (\> 75 % of 1 repetition maximum) more than two times a week
* Control group: sporting or recreational activities, that include repetitive spinal flexion or maintenance of a flexed posture (for example cycling or rowing).
Myeloid Derived Suppressor Cells Control by Signal Regulatory Protein-alpha: Investigation in Hepatocellular Carcinoma

project is to study and develop anti-Signal Regulatory Protein α (SIRPα) antibodies (Ab) as a new immunotherapy strategy in cancer.

Samples harvested from hepatocellular carcinoma (HCC) and ovarian cancer patients will be used in evaluation of the SIRP-CD47 expression and of the effect of the anti-human Signal Regulatory Protein (hSIRP) Ab on various cellular types from patients and healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* adult
* HCC patients (all BCLC stages accepted)
* patient consent for the use of their biological samples

Exclusion Criteria:

* patient with other cancers
* hepatitis C or B positive
* HCC treatment by chemo-embolization under 3 months
* under Sorafenib treatment within the month prior to collection
* underage or under guardianship patients
The Effect of the Hydroxyethyl Starch on Kidney Injury in Pediatric Cardiac Surgery

The investigator will evaluate the influence of colloid administration on postoperative acute kidney injury in pediatric patients undergoing cardiac surgery under cardiopulmonary bypass.

The investigator will randomly divide pediatric patients aged less than 7 years old into crystalloid and colloid groups. Crystalloid group receive only crystalloid, and colloid group receive hydroxyethyl starch (HES, 130/0.4). The maximum volume of HES is limited less than 30 ml/kg. The same transfusion protocol will be applied in both groups. From the day of operation to postoperative 7 days, glomerular filtration rate (GFR), serum creatinin level (Cr) will be checked. Acute kidney injury (AKI) is defined when there is more than 50% increase in Cr when compared to baseline level. The investigator will compare the clinical outcomes including AKI between two groups.

Eligibility Criteria:
Inclusion Criteria:

* Children aged less than 7 years old
* American Society of Anesthesiology (ASA) physical status 1-3

Exclusion Criteria:

* Preoperative creatinine \> 1.5mg/dl
* History of dialysis
* Liver function abnormality
* Diabetes Mellitus
* History of allergic reaction
* Coagulation abnormality
MuLtimodality EvaluatiOn of aNtibody mEdiated Damage in Heart Transplantation (LEONE-HT)

Cross-sectional evaluation of antibody mediated injury in heart transplantation patients through a multimodal approach: electron microscopy, optic microscopy, immunohistochemistry techniques, transthoracic echocardiography, cardiac magnetic resonance, pressure guide wire, intravascular ultrasound

Heart transplant survival has barely improved in the last decades and unsatisfactory for a large proportion of heart transplant recipients. The development of leukocyte antigen antibodies (anti-HLA) in the post-transplant patient is associated to the main causes of graft dysfunction. The mechanisms of this damage are unclear and there's no effective treatment.

The investigators aim is to identify early markers of graft injury through a complete morphological and functional evaluation with histological analysis, immunological assays, advanced imaging techniques and invasive evaluation of coronary vasculature in patients with anti-HLA compared to matching controls.

The investigators propose a cross-sectional study within a large heart transplant cohort. This is a multicentric observational multimodal study. The investigators aim is to establish early characteristics of antibody mediated damage and set the bases for future studies looking for new treatment targets.

Eligibility Criteria:
Inclusion Criteria:

1. Exposed:

   * Heart transplant recipients
   * "De novo" antiHLA detection (after heart transplant):

     * Mean fluorescence intensity (MFI)) \> 2000 for donor-specific antibodies
     * Standard fluorescence intensity (SFI) \> 150 000 for non-donor specific antibodies
   * Detailed immunological history:

     * Determination of anti-HLA antibodies before heart transplant.
     * Serial determination of anti-HLA antibodies during heart transplantation follow-up
   * Known HLA typing of the donor.
2. Non-exposed: Heart transplant procedure contemporary to the index case with negative anti-HLA antibodies.

Exclusion Criteria:

* Recipient of a second HT
* Multiple organ transplantation
* Unknown immunological history
* Recipients sensitized with anti-HLA antibodies against donor's HLA before the transplant
* CMR contrast will not be administered in patients with glomerular filtration rate \< 30 ml/kg/1.73m2
* Patients with implanted cardiac devices or any other magnetic resonance non-compatible metallic prosthetic material will not undergo CMR.
Comparing Gabapentin and Lorazepam for Treating Alcohol Withdrawal

This study will evaluate a safe and useful medication for outpatient detoxification that is as effective as benzodiazepines in the short-term, and more effective in the protracted withdrawal period. Gabapentin (Neurontin) will be compared to a standard benzodiazepine, lorazepam (Ativan), for its effectiveness in treating alcohol withdrawal.


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for alcohol dependence and uncomplicated alcohol withdrawal syndrome.
* Subjects must be medically stable (not likely to require hospitalization for medical complications within 10 days).
* Have a clinical withdrawal assessment prior to study.
* Must be medically acceptable for study treatment. Considerations include no past or present physical disorder that is likely to deteriorate during participation. No ECG abnormality which would likely worsen during participation and no clinical laboratory abnormality that would also suggest deterioration during treatment.
* Able to read, write, and speak English.
* Have a negative urine drug screen for benzodiazepines or other sedative hypnotics, opiates, and stimulates prior to entering the study.

Exclusion Criteria:

* Current diagnosis of any other substance dependence syndrome other than alcohol dependence (excluding nicotine and caffeine dependence).
* Use of pharmacological agents within the last 14 days that are known to lower the seizure threshold or augment or decrease the alcohol withdrawal syndrome.
* History of alcohol withdrawal seizures, epilepsy or delirium tremens.
* Diagnosis of schizophrenia, bipolar disorder or dementia.
* Liver function tests higher than normal.
* History of hepatic encephalopathy, jaundice, ascites, diabetes, or renal disease.
* Females who are pregnant or nursing.
* Subjects with known sensitivity of previous adverse reaction to gabapentin, lorazepam, or other benzodiazepines.
* History of severe GI disease which might render absorption of the medication difficult or produce medical instability of the patient during detoxification which would include active peptic ulcer disease, ulcerative colitis, regional colitis, or evidence by history or physical exam of GI bleeding.
* Unable to provide an informed consent.
Anti-SARS-CoV-2 Inactivated Convalescent Plasma in the Treatment of COVID-19

There is still no effective antiviral drugs and vaccines against SARS-CoV-2 yet now. This is an obsevational study, the investigators collected the clinical information and clinical outcomes of the COVID-19 patients using anti-2019-nCoV inactivated convalescent plasma.The study is to evaluate the efficacy and safety of anti-2019-nCoV inactivated convalescent plasma in the treatment of COVID-19 pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* The participants were diagnosed as COVID-19;
* Participants received anti-SARS-CoV-2 inactivated convalescent plasma
* Written the informed consent.

Exclusion Criteria:

* Participants lacked detailed medical history
HEalth Advocate for Liver Transplant - Pilot

The Health Advocate for Liver Transplant (HEAL-Tx) Pilot is a nonrandomized, open-label intervention pilot of a health advocate intervention aimed to assess feasibility and acceptability of integrating a Health Advocate onto the transplant team. Across studies, health advocate roles vary, and can include coordinating medical care treatment, facilitating financial assistance (e.g., taxi vouchers), and connecting patients to community resources, which can improve self-management, mitigate social risks, and lead to better communication between the healthcare system and the family. In this pilot, the investigators will adapt this intervention for pediatric liver transplant patients and measure acceptability and feasibility according to RE-AIM.


Eligibility Criteria:
Inclusion Criteria:

1. Patients under 18 years if age that have undergone liver transplantation.
2. Subject and/or parent/legal guardian can provide written informed consent and willing to comply with study procedures.
3. Subject and/or parent/ legal guardian is willing to be contacted in the future by study staff.
4. Patient and/or caregiver felt to be a good fit for this pilot by transplant team.

Exclusion Criteria:

* Caregiver unwilling or unable to complete the survey.
* Child is a ward of the state (e.g. foster care) since present circumstances may not be reflective of child's past or future circumstances.
* Non-English, non-Spanish speakers.
* Non-US residents.
* Greater than 18 years of age at the time of enrollment.
Safety, Tolerability and Efficacy of Disulfiram and Copper Gluconate in Recurrent Glioblastoma

This study of DSF-Cu in combination with TMZ for recurrent GBM will evaluate the antitumor effect in patients who have recurrent GBM. Patients will take DSF-Cu daily during their routine standard of care with TMZ therapy for approximately 6 months. Patients will be evaluated for response every 8 weeks. Patients will be followed up 2 years after the last dose of DSF-Cu.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed GBM (WHO grade IV).
* The subject must have completed RT with concurrent TMZ at least 12 weeks prior to the planned start of treatment on this study UNLESS there is pathological verification of recurrent tumor and at least 4 weeks have elapsed since the end of RT with concurrent TMZ.
* Experienced first unequivocal progression of tumor by magnetic resonance imaging (MRI) \[as assessed via Radiologic Assessment in Neuro-Oncology (RANO) criteria within 3 months from the last dose of TMZ.
* Karnofsky performance status (KPS) of at least 60%.
* Willing to remain abstinent from consuming alcohol.
* Recovered from the toxic effects of prior therapy to \< grade 2 toxicity per NCI CTCAE prior to study registration (except lymphopenia).
* Meets laboratory criteria for the following parameters: ANC, platelets, hemoglobin, total bilirubin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, BUN and creatinine.
* 11. Females of childbearing potential must be willing to use an acceptable method of birth control (i.e., intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study.

Exclusion Criteria:

* Radiographic evidence of leptomeningeal dissemination, gliomatosis cerebri, infratentorial tumor, or disease at sites remote from the supratentorial brain.
* Enrolled in another clinical trial testing a novel therapy or drug within the past 4 weeks.
* Received more than one course of radiation therapy or more than a total dose of 75 Gy.
* History of allergic reaction/hypersensitivity to temozolomide, dacarbazine, DSF or Cu.
* Treatment with the following medications are contraindicated with DSF: metronidazole, isoniazid, dronabinol, carbocisteine, lopinavir, paraldehyde, ritonavir, sertraline, tindazole, tizanidine, atazanavir.
* Fever within 3 days prior to study enrollment.
* Active or severe hepatic or renal disease.
* Grade 2 or higher peripheral neuropathy or ataxia per NCI CTCAE
* History of idiopathic seizure disorder schizophrenia, or psychosis unrelated to glioblastoma, corticosteroid, or anti-epileptic medications.
* History of Wilson's disease.
* History of hemochromatosis.
* Pregnant or breastfeeding.
Effect of Gabapentin on Sleep and Opioid Use Following Rotator Cuff Repair

The goal of this clinical trial is to compare the effects of gabapentin in patients undergoing rotator cuff repair surgery. The main question it aims to answer is whether gabapentin can improve postoperative pain and sleep quality. Participants in this study will be randomized to either take gabapentin after surgery or a placebo after surgery.

Perioperative gabapentin use has been established in prior literature to decrease postoperative opioid use; however, all of these studies have evaluated gabapentin given by an anesthesia team in the immediate pre- or intraoperative period. No known literature exists regarding scheduled post-operative oral gabapentin use in regards to pain control and opioid use. Sleep quality still tends to be a frequent concern associated with rotator cuff injury and shoulder surgery in general. The added known benefit of somnolence or drowsiness, in addition to aid in sleep, with use of gabapentin may also contribute to improved sleep quality following rotator cuff repair.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed traumatic or degenerative rotator cuff tear undergoing primary arthroscopic repair
* between the ages of 18 and 65 years old

Exclusion Criteria:

* chronic pre-operative narcotic pain medication use
* undergoing superior capsular reconstruction / balloon interposition etc
* \< 18 y/o or \> 65 y/o
* bilateral rotator cuff tear
* currently taking prescribed sleep-aid medications
* history of fibromyalgia or chronic pain syndrome
* pain management patient
* narcolepsy diagnosis
* diagnosis of cervical radiculopathy
* reported non-shoulder pain interfering with sleep
Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy

RA (Rheuatoid arthritis) is a multisystem disease that mainly involves joints resulting in destructive arthritis if not treated rapidly. Inspite of various advances in field of early diagnosis and treatment of RA, there is still a need for better understanding of the efficacy and safety of various combinations of conventional DMARDS, and to rank them in order accordingly, so as to give a clearer vision for further management of RA once MTX monotherapy fails, so as to achieve remission as soon as possible. The study will be conducted at the Department of Clinical Immunology, JIPMER (Jawaharlal Institute of Postgraduate Medical Education \& Research). patients who fail methotrexate monotherapy will be randomised to 2 treatment arms - either a combination of Sulfasalazine (SSZ), Hydroxychloroquine (HCQ) and Methotrexate (MTX) or Leflunomide (LEF), Hydroxychloroquine (HCQ) and Methotrexate (MTX)

Patients aged ≥18 years, fulfilling the 2010 ACR EULAR criteria for RA (symptom duration less than two years) , having more than 4 joints involved \& having moderate to severe disease activity (DAS28≥3.2) will be invited to participate. After providing written informed consent, eligible patients will be first started on MTX monotherapy \& only patients who have persistant moderate disease activity (DAS28 ESR \> 3.2) will be randomized into two groups. Block randomization will be done to generate random allocation sequence

Group 1 - will receive MTX+LEF+HCQ Group 2- will receive MTX+SSZ+HCQ

DMARD dosages used are: MTX 25 mg/week orally (dosage after 6 weeks),SSZ 2g/d (after 4 weeks) LEF 20 mg/day (dosage after 2 weeks) and HCQ 200 mg/day. Glucocorticoids will be given in an oral tapering scheme. All patients will be prescribed folic acid (10 mg/week) during MTX prescription.

Eligibility Criteria:
Inclusion Criteria:

Age \>18 years satisfying ACR-EULAR criteria for RA

1. Polyarthritis (\>4 joints)
2. Disease duration of less than 2 years
3. Patients with moderate to severe disease activity (DAS28\>3.2)
4. Patients who have failed to respond to initial Methotrexate monotherapy

Exclusion Criteria:

1. End stage disease (deformed fixed joints)
2. Patients with vasculitis, extra-articular features like interstitial lung disease8
3. Contraindications to DMARD therapy (Chronic Alcoholism, Chronic liver disease, Evidence of acute/chronic infection, Chronic kidney disease, Patients with leucopenia (\<3.0×109/l), thrombocytopenia (\<150×109/l), AST/ALT\>2× upper normal value and creatinine clearance \<30ml/minute )
4. Pregnant, lactating women ; patients (both men and women) of reproductive age group unwilling for contraceptive use who have not completed the family
5. Patients unable to come for regular follow up
Brief Internet-delivered CBT After ACS

The purpose of the present pilot study is to evaluate the feasibility and potential efficacy of a brief, internet-delivered CBT protocol provided early after acute coronary syndrome (ACS).

Acute coronary syndrome (ACS; myocardial infarction (MI) or unstable angina (UA)) is one of the leading causes of mortality and health loss globally. ACS is a stressful and potentially life-threatening cardiovascular event, and many patients develop symptoms of post-traumatic stress (PTSS) and cardiac anxiety post ACS, which have been shown to negatively affect patients' long-term cardiovascular prognosis.The aim of the proposed pilot study is to develop and evaluate a brief internet-delivered exposure-based CBT intervention provided early following ACS to reduce ACS-related PTSS, cardiac anxiety. and increase physical activity and quality of life. Patients with recent ACS (≥ 4 weeks to 6 months) and with elevated PTSS and anxiety will be eligible. After informed consent, patients will be randomized to internet-delivered CBT (N=15) or to a wait-list control group (N=15). The treatment is a 5 week, therapist-guided, internet-delivered intervention which includes imaginal exposure, interoceptive exposure, and exposure in-vivo. Assessments will be conducted at baseline, immediate post-treatment, and 2- and 6- months after treatment. The wait-list will be crossed over to CBT after completion of the 2 month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* (A) ACS ≥ four weeks to six months before assessment (MI type 1 STEMI/NSTEMI and UA)
* (B) Age 18-80 years
* (C) Symptoms of PTSD and/or cardiac anxiety that leads to distress and/or interferes with daily life (PCL5; ≥ 10, CAQ: ≥20)
* (D) On standard of care medical treatment for the cardiac condition according to Swedish cardiovascular guidelines
* (E) Ability to read and write in Swedish.

Exclusion Criteria:

* (F) Heart failure with severe systolic dysfunction (ejection fraction ≤ 35%)
* (G) Significant valvular disease
* (H) Planned coronary artery bypass surgery or percutaneous interventions
* (I) Any medical restriction to physical exercise
* (J) Severe uncontrolled medical illness i.e., advanced cancer
* (K) Grade 3 hypertension (i.e., blood pressure ≥ 180 systolic and/or 110 diastolic)
* (L) Severe psychiatric disorder, active suicidal ideations or cognitive impairment that precludes provision of informed consent or study activities
* (M) Alcohol dependency
* (N) Ongoing psychological treatment.