cyrilzakka/clinical-trials huggingface dataset:
Baclofen in Managing Acute Alcohol Withdrawal

The study goal is to investigate whether administration of oral baclofen forms an adequate treatment option in the management of acute alcohol withdrawal. The investigators will compare placebo with doses of baclofen 30 and 60 milligram per day (mg/day) in a randomized controlled trial including patients receiving symptom triggered diazepam.

The conducted study will be randomized and single-blind (patients). After signing informed consent, the participants will be randomized in one of three groups: - placebo - baclofen 30 mg/day - baclofen 60 mg/day. The participants will be given a first administration after which the participant can receive Clinical Institute Withdrawal Assessment (CIWA-ar) score triggered diazepam, frequently assessed for at least 7 days. The primary outcome measure is the number of participants who received additional diazepam during these 7 days. The secondary outcome measure is the amount of diazepam received per group.

Eligibility Criteria:
Inclusion Criteria:

* Be an inpatient at the Psychiatry unit at UZBrussel at time of study enrollment.
* Be able to sign informed consent.
* Be male/female aged 18-60
* Primary diagnosis of alcohol use disorder.

Exclusion Criteria:

* Pregnancy and breastfeeding.
* Benzodiazepine use of more than the equivalent of diazepam 25 mg /day.
* Psychosis, confusion and acute mania.
* Parkinson's disease.
* Use of tricyclic antidepressants.
* Use of opioids.
* Known baclofen or benzodiazepine sensitivity or allergy.
* Unable to take oral medication.
* epidermal growth factor receptor (EGFR) \< 60 (blood samples are routinely performed at intake).
* Prior diagnosis of epilepsy.
* Lactose intolerance.
Oral Contraceptive Hormone-free Interval Pituitary/ Ovarian Activity

The degree of suppression and subsequent activation of the hypothalamic-pituitary-ovarian axis during the hormone-free interval in combined oral contraceptive (COC) hormone users varies depending on the dose of ethinyl estradiol in the formulation. This variation in activation may be associated with different side effects during the hormone free interval. Progesterone (P) remained suppressed during all 6 COC regimens (\<1.8 ng/mL), which indicates continuous contraceptive efficacy during the 7-day hormone free interval of all formulations studied.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, reproductive age women
* 18 to 35 years old,
* seeking contraception from the general gynecology clinics of the LAC and USC Medical Center w
* taking one of 6 possible monophasic COC formulations for at least 3 cycles prior to enrollment
* regular menstrual cycles prior to COCs

Exclusion Criteria:

* Irregular bleeding
* bilateral oophorectomy
* amenorrhea
* hormone-sensitive cancer
* concurrent medications known to interfere with steroid metabolism (i.e., barbiturates, phenytoin, carbamazepine, ethosuximide, primidone, rifampin, tetracycline)
HCC Surveillance: Comparison of Abbreviated Non-contrast MRI and Ultrasound Surveillance in Cirrhotic Patients With Suboptimal Ultrasound Visualisation

All international guidelines recommend 6-monthly ultrasound surveillance for patients at risk for liver cancer (hepatocellular carcinoma or HCC), such as patients with cirrhosis. The aim of surveillance is to detect HCC at an early stage when it is still potentially curable. Currently only 4 out of 10 HCCs are detected at the early stage.

Ultrasound surveillance for HCC has a wide ranging sensitivity, dependent on many factors such as operator experience, patient body habitus and liver parenchymal heterogeneity due to chronic liver disease and cirrhosis. In a select group of patients, surveillance ultrasound can be suboptimal or near non-diagnostic.

Currently no guideline offers an alternative surveillance tool for patients who have suboptimal surveillance ultrasounds.

The investigators plan to conduct a prospective study to examine the diagnostic performance of abbreviated non-contrast MRI (aNC-MRI) versus ultrasound, in a select group of cirrhotic patients with poor ultrasound visualisation.

Eligibility Criteria:
Inclusion criteria

* Patients with cirrhosis (all causes of cirrhosis, except obscure causes such as vascular or congenital fibrosis) AND reduced visualisation of their liver on ultrasound (vB and vC).
* The criteria of cirrhosis can be obtained with any of the following methods:

  1. Histologically by liver biopsy
  2. Past signs of decompensated liver disease such as ascites, encephalopathy, varices or bacterial peritonitis
  3. Clinically suspicion of cirrhosis PLUS one of the following:

     1. Radiological evidence of morphologic changes of the liver and evidence of portal hypertension on US, CT or MRI examinations, including the identification of hepatic surface nodularity, splenomegaly, portal collaterals, varices and ascites
     2. Fibroscan (transient elastography) median liver stiffness \>12.5 kPa, the Fibroscan must be performed by an experienced technician and interpreted by the hepatologist
     3. Platelet count \<100 (x10\^9/L) with no alternative cause
* Absence of previous history or current suspicion of HCC - Absence of HCC is defined by liver US, multiphase CT or contrast-enhanced MRI within 6 months prior to surveillance
* Patient is able to comply with scheduled visits, evaluation plans and other study procedures in the opinion of the investigator
* Patient is willing to provide written informed consent

Exclusion criteria

* Contraindications to MRI scan (defibrillator, pacemaker, metallic foreign body, severe claustrophobia etc.)
* Contraindications to gadolinium
* Age above 85 years old or younger than 20 years old
* Pregnancy or breast feeding
* Any other condition which, in the opinion of the Investigator, would make the patient unsuitable for enrolment for the trial or could interfere with the completion of the study
Assessing Force-velocity Profile: an Innovative Approach to Optimize Cardiac Rehabilitation in Coronary Patients

Cardiac rehabilitation includes aerobic and anaerobic training adapted to cardiovascular pathology for which cardiac rehabilitation is prescribed. It is essential to adapt the content of these cardiac rehabilitation sessions to optimize aerobic and anaerobic performance and quality of life. Improvement of the first ventilatory threshold is one of the main objectives since it illustrates the adaptation of the patient to submaximal exercise, typical of everyday life.

The research laboratory "Autonomous Nervous System - Epidemiology, Physiology, Engineering, Health" (SPA-EPIS) has an international expertise in training optimization in top-athletes. He have shown the importance of the relationship between the power-force-velocity profile and athletes performances.

In this sudy, each patient has a force and a velocity that can be optimized with training to achieve maximum power. This optimization can be evaluated through a force-velocity profile, measured from an only sprint on a cycloergometer.

The hypothesis that force-velocity profile could be used in cardiac rehabilitation in coronary patients to induce a force-velocity balance adapted through personalized sessions and regular medical follow-up.

This prospective, controlled, randomized and open label study will attempt to evaluate further the relevance of force or velocity training based on the initial force-velocity profile of coronary patients included in the cardiac rehabilitation program in the University Hospital of Saint-Etienne.

Eligibility Criteria:
Inclusion Criteria:

* Acute coronary syndrome treated within the last 6 months
* Medical revascularization (angioplasty ± stenting) or surgical (coronary artery bypass)
* During initial effort test: Maximum aerobic power≥ 60 watts for women and ≥ 80 watts for men
* Patient affiliated or beneficiary to social security
* Signed informed consent

Exclusion Criteria:

* Significant co-morbidities limited practice of physical activity
* Inability to submit to medical monitoring of the program
* Patient deprived of liberty or patient under guardianship
* Pregnant woman
The Tracking Molecular Evolution for NSCLC (T-MENC) Study

Tumor genomic clonal evolution assessed with liquid biopsy of stage IB,II and IIIA non-small cell lung cancer patients after getting radical resection. Plasma circulating tumor DNA (ctDNA) analysis detects molecule residual disease and predicts recurrence in patients. The concordance of the relative abundance of mutations in plasma ctDNA with cancer recurrence.

In the study, 200 of stage IB,II and IIIA non-small cell lung cancer patients obtained radical resection will be recruited. All the patients will receive biopsy genotype assay and ctDNA liquid biopsy. The abundance of mutations of ctDNA was tracked at 4 time points, including:

1. st: 10 Days after patients received radical resection.
2. nd: When patients finished the chemotherapy or target drug delivery two cycles.
3. rd: 10 Days after patients finished the chemotherapy or target drug delivery four cycles.
4. th: When tumor recrudescence / 2 years after radical resection.

Tumor genomic clonal evolution was assessed by analyzing the relative abundance of mutations in plasma circulating tumor DNA (ctDNA).

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent and assigned.
2. Newly diagnosed and histological or cytological confirmed stage IB-IIIA lung adenocarcinoma or non-smoking squamous cell carcinoma patients according to the AJCC staging system.
3. Expected radical resection.
4. Patients expected more than 3 months of survival time.
5. Willingness to comply with required protocols and give permission to use the data for clinical research and products development.

Exclusion Criteria:

1. Patients who want Neo-adjuvant therapy.
2. Patients with T3-4N1 Pancoast tumors (superior sulcal tumors).
3. Multi-station N2 non-small cell lung cancer with lymph node metastasis.
4. Eastern cooperative oncology group (ECOG) performance status \> 2 after postoperative chemotherapy
5. Eastern cooperative oncology group (ECOG) performance status \> 4 after postoperative targeted therapy.
6. Patients must never ever has received for any history of radiotherapy/ chemotherapy/surgery before.
7. Patients have other primary cancers.
8. Known central nervous system metastasis.
9. Patients expected less than 3 months of survival time.
10. Other situations mismatch this program.
Exercise Training and Cardiovascular Function in Obesity and in Type 2 Diabetes

Obesity and diabetes increase cardiovascular risk by complex and incompletely known mechanisms. The aims of this study are :

1. to compare cardiac and vascular functions at rest and during exercise in 4 groups of age-matched men, without cardiovascular diseases but exhibiting increasing cardiovascular risk: trained and untrained healthy volunteers, obese and type 2 diabetic subjects
2. to test the effects of a 8-weeks long individualized training program on these functions in obese subjects and in diabetics patients.

Obesity, especially in its truncal distribution, and type 2 diabetes, increase cardiovascular risk. Mechanisms underlaying both early preclinical, and clinical cardiovascular complications are complex and still incompletely clarified.

However, relationship between central, i.e. cardiac, and peripheral, i.e. vascular dysfunctions remains unclear, as well as their respective role in reduced exercise tolerance in these populations.

Moreover, exercise training can improve both metabolic status and cardiovascular risk, and thus, has proven useful in management and prevention of chronic metabolic diseases. Nevertheless, respective effects of training on cardiac and vascular functions, and on their interaction at rest, but also during exercise, need to be clarified.

Therefore, the aims of this study are :

1. to compare cardiac and vascular functions at rest and during a local maximal leg exercise in 4 groups of age-matched men, without cardiovascular diseases but exhibiting increasing cardiovascular risk: trained and untrained healthy volunteers, obese and type 2 diabetic subjects
2. to test the effects of a 8-weeks long individualized training program on these functions in obese subjects and in diabetics patients.

Eligibility Criteria:
Inclusion Criteria:

* non-diabetic obese subjects and type 2 diabetic subjects

Exclusion Criteria:

* smoking
* known peripheral artery insufficiency
* heart failure
* uncontrolled hypertension
* thyroid disease
* insulin dependent diabetes
* for diabetics subjects : HbA1c \> 10 %
The Effect of Exercises on Physiological Changes and Clinical Symptoms in Allergic Rhinitis Patients

1. Moderate exercise training decrease cytokine response and rhinitis symptoms in patients with allergic rhinitis
2. Moderate exercise training combined with vitamin C supplementation decrease cytokine response and rhinitis symptoms in patients with allergic rhinitis
3. Moderate exercise training combined with vitamin C supplementation has more beneficial effects than moderate exercise training alone for decreasing cytokine response and rhinitis symptoms in patients with allergic rhinitis


Eligibility Criteria:
Inclusion Criteria:

The inclusion criteria included patients with allergic rhinitis who had a clinical history of persistent rhinitis, and had positive skin prick test (wheal diameter ≥ 3 mm) to house dust mite (D. pteronyssinus).

Exclusion Criteria:

Subjects with known asthma, chronic rhinosinusitis, hypertension or cardiovascular diseases were excluded.
Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia

To further characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia

This is a long-term, multicenter, open-label trial designed to examine the long-term safety and tolerability of brexpiprazole in adolescent subjects (ages 13-17) with a DSM-5 diagnosis of schizophrenia.

Eligibility Criteria:
Inclusion Criteria:

* Male \& female subjects 13-17 years of age, inclusive.
* Subjects who turn 18 during trial 331-10-234 are permitted in this trial.
* Subjects with a current primary diagnosis of schizophrenia, as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria and confirmed by the K-SADS-PL completed at time of entry into Trial 331-10-234. For de novo subjects who did not participate in Trial 331-10-234, the initial diagnosis of schizophrenia must be made and documented, and the diagnosis confirmed by the K-SADS-PL at screening.
* Subjects who, in the investigator's judgment, require treatment with antipsychotic medication(s).

Exclusion Criteria:

* Subjects with a DSM-5 diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening
* Subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia, or other cognitive disorders; subjects with psychotic symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (e.g., medication, illicit drug use).
* History of failure of clozapine treatment or response to clozapine treatment only.
* History of neuroleptic malignant syndrome
IC-CS Risk: Patient Outcomes

This study is looking at the impact of the implementation of a cesarean risk calculator on cesarean delivery and maternal morbidity rates.

In this study a cesarean risk calculator will be instituted as a part of standard of care in a randomized rollout at 14 labor and delivery clinical sites across 4 institutions. The leadership at all of the sites have planned to implement this intervention for routine use at both sites. This study will evaluate cesarean delivery rates and maternal morbidity before and after implementation at each site.

Eligibility Criteria:
Inclusion Criteria:

All postpartum patients who were eligible for cesarean risk calculator utilization:

* delivery of a full-term (greater than or equal to 37 weeks) singleton gestation after presenting
* with intact membranes
* undergoing an induction of labor from cervical dilation less than or equal to 2cm

Exclusion Criteria:

Postpartum patient who had a prior pregnancy resulting in Cesarean delivery
Allogeneic Stem Cell Transplantation (ALLO-SCT) in Elderly: 17-years Retrospective GITMO Survey

The age of patients' population is increasing every year, as the life expectancy. Thus, the incidence and prevalence of hematological cancers is increasing. In particular, acute leukemias and myelodisplastic syndromes are the most frequent diseases of the hematopoietic system. Allogeneic stem cell transplantation (allo-SCT) is the main therapeutic options for these diseases, and the number of allo-SCTs in the elderly is currently in progressive growth. This is partially due to the improvement of the allo-SCT procedure over the years, with the amelioration of donor selection, HLA typing, graft versus host disease (GVHD) and infections prophylaxis and treatment.

Nevertheless, there is still an unmet clinical need, represented by the lack of extensively and detailed outcome analysis of elderly patients addressed to allo-SCT. With this aim, we planned this retrospective analysis of allo-SCTs in patients older than 60 years, within the GITMO transplant activity of the last 17 years. This study will help us in designing future prospective trials, including a comprehensive geriatric assessment of frailty, in order to address to allo-SCT those elderly who have the highest probability to achieve the best long term outcome with the lowest transplant-related mortality and morbidity.


Eligibility Criteria:
This study will enrol patients older than 60 years who received hematopoietic stem cell transplantation (HSCT) between 1st January 2000 and 31st December 2017.
Efficacy and Safety of Rituximab to That of Calcineurin Inhibitors in Children With Steroid Dependent Nephrotic Syndrome

Nephrotic syndrome in children is primarily caused by minimal change disease. Majority of these patients respond well to corticosteroids. However, as many as 70% of children with nephrotic syndrome experience at least one relapse, and 30% develop a more complicated course with frequent relapses (FRNS)(≥2 relapses/ 6 months) with or without steroid dependency (SDNS)(relapse during tapering or within 2 weeks after discontinuation of corticosteroids). Repeated and prolonged courses of steroids in these children often result in long-term complications. The goal of the treatment is to reduce the rate of relapses, the cumulative dose of corticosteroids, and the incidence of serious complications. In order to minimize the side effects of steroid therapy, different steroid sparing agents such as cyclophosphamide, calcineurin inhibitors(CNI), levamisole, and mycophenolate mofetil (MMF) have been used in SDNS. Whereas CNI are usually considered the steroid sparing drug class of first choice, rituximab is increasingly used as alternative to minimize CNI toxicity. Various prospective studies suggest that Rituximab, a B cell depleting monoclonal antibody, could be a safe and effective alternative to steroid or immunosuppressants to achieve and maintain remission in this population.Single rituximab course have been shown to be efficacious for 6 to 12 months and the side effect profile observed to date is very benign. Studies comparing the usefulness of these agents are lacking. In our proposed randomized controlled trial, the investigators want to compare the efficacy and safety of CNI to that of Rituximab in treating children with SDNS.


Eligibility Criteria:
Inclusion Criteria:

* Children between 3 and 16 years with SDNS
* Minimal Change disease/FSGS/MesPGN/ as per Kidney Biopsy report.
* Estimated glomerular filtration rate (eGFR) \>80 ml/min per 1.73 m2 at study entry.
* Remission at study entry (trace or nil proteinuria, as determined by the dipstick test or \<100 mg/dl for at least 3 days).
* Not received any steroid sparing agent previously.
* Parents willing to give informed written consent.
* Ability to swallow tablet

Exclusion Criteria:

* Known etiology (e.g., lupus erythematosus, IgA nephropathy, amyloidosis, malignancy, other secondary forms of NS)
* Patients with severe leucopenia (leucocytes \<3.0× 1000 cells/mm3), severe anemia (haemoglobin \<8.9 g/dl), thrombocytopenia (platelet \<100.0 × 1000 cells/mm3) or deranged liver function tests (AST or ALT to \>50 IU/L ) at enrolment.
* Known active chronic infection (tuberculosis, HIV, hepatitis B or C) Live vaccination within 1 mo
Pain and Anxiety Management With Oral Narcotic for Pediatric Suture Repair

The purpose of this study is:

* To determine whether oral narcotic medication versus placebo improves the pain and anxiety scores for pediatric patients requiring laceration repair in the pediatric emergency department and receiving the standard of care with lidocaine treatment
* To evaluate for a statistical difference in pain scores in children during laceration repair
* To evaluate for a statistical difference in State-Trait Anxiety Inventory for Children (STAIC) scores during laceration repair

A prospective, double-blind, placebo-controlled, randomized clinical trial in a tertiary care pediatric emergency department with an annual census of 80,000 visits per year. Patients will be randomized by a randomization table with block randomization in the pharmacy to the oral narcotic or placebo group, and the pharmacist will be the only person aware of the randomization status of the patient. Allocation concealment will be ensured by opaque, sealed envelopes kept in the Emergency Department Pharmacy. Guardians of patients age 2 to 17 years of age will be consented for enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Age 2 to 17 years
* Laceration of the skin and/or subcutaneous tissue requiring sutures
* American Society of Anesthesiologists (ASA) score of I or II

Exclusion Criteria:

* Major injuries in addition to laceration (suspected fracture, intracranial, intrathoracic, or intraabdominal bleeding or organ injury)
* Abnormal neurologic examination (such as head injury)
* Severe congenital heart disease
* Pregnancy
* Known opiate or acetaminophen allergy
* Require conscious sedation
* Have had narcotic or acetaminophen administration within 4 previous hours