cyrilzakka/clinical-trials huggingface dataset:
Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia

This study will examine the physical responses brought on by clozapine and haloperidol in people experiencing their first episode of schizophrenia.

This is a longitudinal double blind, 2- 5 year study of the clinical, neuroendocrine and biochemical response to clozapine (CLOZ) and haloperidol (HAL) in a group of "first episode" schizophrenic (RDC) patients. Within the protocol, we compare the differential effects of the two drugs over the short term (12 weeks) and the long-term (2-5 years); we evaluate the relationship between change in prolactin level and clinical response of the patients; and we search for biochemical predictors and correlates of clinical response. To achieve the study aims, we employ a drug-washout period, a 12-week acute treatment period; and an 88 - 260 week follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* RDC diagnosis of schizophrenia
* Men and women, without regard to race/ethnicity,
* Aged 18-45
* Acutely psychotic with a score of at least 3 on one of the psychotic scale items of the Brief Psychiatric Rating Scale (BPRS) (hallucinations, delusions, conceptual disorganization) and a total BPRS of \> 21 (on a 0 - 6 scale);
* Require treatment with neuroleptic drugs on a clinical basis;
* The patient (or the patient's authorized legal representative) must understand the nature of the study and sign the informed consent;
* Be within the first episode of a psychotic disorder;
* Have a history of neuroleptic treatment of \< 12 weeks;
* Likely to remain in the study for 2 years.

Exclusion Criteria:

* Substance dependence in the last six months
* History of seizure or blood dyscrasia
* Major medical illness
* Pregnancy or Lactation
BDPP Treatment for Mild Cognitive Impairment (MCI) and Prediabetes or Type 2 Diabetes Mellitus (T2DM)

Mild Cognitive Impairment (MCI) represents a group of persons who are at risk of incident dementia in the near-term. Persons with MCI who have deficits in short-term recall (amnestic MCI) are at significant risk of incident Alzheimer's disease (AD) (termed prodromal AD), and thus represent a worthy target for secondary prevention interventions.

There is increasing evidence that risk factors for metabolic syndrome (such as prediabetes and type 2 diabetes) increase risk of incident cognitive impairment and possibly AD, and evidence that the neurons of the AD brain are in fact insulin resistant with diminished glucose uptake under physiological conditions. Thus, persons with MCI and prediabetes or type 2 diabetes may be at particular risk of incident cognitive impairment and AD.

A large clinical trial (ACCORD)1 demonstrated that tight control of peripheral blood glucose does not improve cognitive (or other health) outcomes in older persons with peripheral insulin resistance. Thus, there is a need to target cognitive outcomes in persons with MCI and metabolic risk factors, and a drug targeting insulin resistance with good blood-brain-barrier (BBB) penetrance can potentially accomplish these objectives. While there is a phase III study of intranasal insulin targeting this strategy, nutraceuticals offer a low-tech solution that would be more suitable to future secondary prevention trials in MCI.

Bioactive Dietary Polyphenol Preparation (BDPP) is a combination of two nutraceutical preparations grape seed polyphenolic extract (GSE), and resveratrol that contain abundant concentrations of polyphenols. The investigators have found that oral BDPP administration was associated with improved cognition and brain plasticity long-term potentiation (LTP) in mouse models of metabolic syndrome and AD, as well as lowering brain amyloid and tau burden in an AD mouse model2-4. The investigators have demonstrated excellent absorption of oral BDPP in a small study in humans and similarly excellent CSF penetration of oral BDPP in rats, but it is crucial to demonstrate safety and CSF penetration of oral BDPP in humans to assess its potential as a treatment for MCI and prediabetes or type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Age 50-90 years inclusive
* Amnestic MCI
* Impaired fasting glucose (IFG), defined by American Diabetes Association criteria (fasting blood sugar between 100 and 125 mg/dl) or clinically stable type 2 diabetes
* Knowledgeable informant (KI) who spends at least 5 hours/week with the participant and can provide information about the participant's psychosocial functioning

Exclusion Criteria:

* Deemed too unstable medically or neurologically to safely enroll in trial of research medication
* Type 1 Diabetes Mellitus
* Diagnosis of dementia due to Alzheimer's disease
Hypersensitivity to Phosphodiesterase 3 Inhibition in Post-Traumatic Headache

To investigate whether cilostazol (phosphodiesterase 3 inhibitor) induces headache with migraine-like features in people with persistent post-traumatic headache (PTH) attributed to mild traumatic brain injury (mTBI).


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years of age upon entry into screening
* History of persistent headache attributed to mild traumatic injury to the head for ≥ 12 months and in accordance with the International Classification of Headache Disorders, 3rd Edition (ICHD-3)
* ≥ 4 monthly headache days on average across the 3 months prior to screening
* Provision of informed consent prior to initiation of any study-specific activities/procedures.

Exclusion Criteria:

* \> 1 mild traumatic injury to the head
* History of any primary or secondary headache disorder prior to mild traumatic injury to the head (except for infrequent episodic tension-type headache)
* History of moderate or severe injury to the head
* History of whiplash injury
* History of craniotomy
* History or evidence of any other clinically significant disorder, condition or disease (except for those outlined above) than, in the opinion of the site investigator, would pose a risk to subject safety or interfere with study evaluation, procedures or completion
* The subject is at risk of self-harm or harm to others as evidenced by past suicidal behavior
* Female subjects of childbearing potential with a positive pregnancy test during any study visit
* Cardiovascular disease of any kind, including cerebrovascular diseases
* Hypertension (systolic blood pressure of ≥150 mmHg and/or diastolic blood pressure of ≥100 mmHg) prior to the start of infusion on the experimental day
* Hypotension (systolic blood pressure of ≤90 mmHg and/or diastolic blood pressure of ≤50 mmHg)
* Initiation, discontinuation, or change of dosing of prophylactic medications within 2 months prior to study inclusion
* Intake of acute medications (e.g. analgesics, triptans) within 48 hours of infusion start
* Baseline headache intensity of \>3 on an 11-point numeric rating scale (0 being no headache, 10 being the worst imaginable headache)
* Baseline headache with migraine-like features or self-reported baseline headache that mimics the subjects' usual headache with migraine-like features
Impact of Narrative Medicine (Workshop Reflexive Writing)

Objective: The aim of this study is to assess the impact of an educational program of Narrative Medicine "workshop reflexive writing "dedicated to medical students on the satisfaction of standardized patients.

Design: Randomized Controlled Trial in 2 arms. Participants: Medical students (4th years) of the University Paris Descartes. Methods: Participants will be randomized in two groups. The allocation of participants will be done by a computerized randomization list, the sequence will be created by an independent statistician. Participants will be blinded of the study hypothesis. Allocation concealment will be provided because only the statistician will have access to the randomization list.

A program of Narrative Medicine in Class-led instruction "workshop reflexive writing "vs "workshop reading medical publication".

Outcome: The primary endpoint will be the satisfaction of standardized patient relative to the empathy of the medical students. The secondary endpoints will be the empathy of the medical students; recommendation of the student by the standardized patients to friends or relatives; students' satisfaction.

Potential interests: The investigators believe that the workshop "reflexive writing" can develop the thinking of the student with respect to his behavior with the patient, and so the relation between student and patient.


Eligibility Criteria:
Inclusion Criteria:

* All students in the fourth year of medical school have chosen for their first 2 quarters to complete an internship in clinical hospital departments (i.e. where direct contact with patients)

Exclusion Criteria:

* All students refusing to participate in the study.
* All students repeaters.
Effect of Rifampin on the Pharmacokinetics of Ixabepilone in Patients With Advanced Cancer

The purpose of this study is to test how rifampin affects the removal of BMS-247550 (ixabepilone) from the body.


Eligibility Criteria:
Inclusion Criteria:

* Up to three prior chemotherapy regimens
* Measurable or non-measurable disease
* Available for treatment and follow-up

Exclusion Criteria:

* Neuropathy
* Uncontrolled cardiovascular disease
* Refusal to participate in genetic analysis
European Society of Cutaneous Lupus Erythematosus (EUSCLE)

Cutaneous lupus erythematosus (CLE) is a disease with a wide spectrum of clinical manifestations and a variable prognosis. The aim of the study is to create a standardized evaluation of the different subtypes of this disease in order to receive an overview of the spectrum of clinical and laboratory features as well as the therapeutic strategies for patients with CLE.

Methods: A core set questionnaire has been developed in the course of the "European Society of Cutaneous Lupus Erythematosus (EUSCLE)", and a total of 40 patients (32 females, 8 males) in two centres, Germany and Sweden, were included in this study. Results: CLE was diagnosed in 39 individuals (5 with acute CLE, 10 with subacute CLE, 13 with chronic CLE, and 18 with intermittent CLE) and one individual presented with a systemic manifestation of the disease. Furthermore, disease onset and duration as well as activity and damage of skin lesions using a modified CLASI were examined. Interestingly, 75% of the patients with CLE showed a positive history of photosensitivity, but only 62.5% exhibited characteristic lesions after standardized phototesting. Laboratory analysis revealed positive antinuclear antibodies in 50% of the patients, positive anti-Ro/SSA in 12 and positive anti-La/SSB antibodies in 8 cases. The predominantly used treatments included sunscreens (38 patients), topical steroids (31 patients), topical calcineurin inhibitors (12 patients), chloroquine (19 patients), hydroxychloroquine (11 patients), and systemic steroids (12 patients). Conclusions: The new core set questionnaire enables the clinician to characterize the different skin manifestations involved in CLE and to evaluate disease activity and reasonable treatment modalities. Furthermore, epidemiological data and laboratory features can be assessed for the various subtypes. In the future, this standardized evaluation might lead to the development of diagnostic guidelines and evidence based therapeutic strategies thus improving quality of care for patients with CLE.

Eligibility Criteria:
Inclusion Criteria:

* systemic or cutaneous lupus erythematosus confirmed by histological analysis
* written informed consent available prior to any study-procedures

Exclusion Criteria:

* patients with conditions that are contrary to the above mentioned criteria
Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)

The goal of this clinical trial is to investigate treatment with psilocybin and psychotherapy for the treatment of people with Alcohol Use Disorder (AUD). The main question\[s\] it aims to answer are:

* Does treatment with psilocybin and therapy help reduce alcohol consumption more than placebo and therapy?
* Is treatment with psilocybin and therapy safe for participants?

Participants will

* Attend 13 study visits
* Take part in therapy sessions including 2 treatment sessions with either psilocybin or placebo
* Record their daily alcohol consumption on study specific device

Researchers will compare psilocybin and placebo groups to see if alcohol consumption is decreased.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe diagnosis of AUD as measured by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria using Structured Clinical Interview for DSM-5 by the investigator.
* Expressed a wish to reduce or stop alcohol consumption.
* Generally healthy with no unstable medical conditions, as determined by medical history, physical examination, routine blood labs, electrocardiogram, urine analysis, and urine toxicology.

Exclusion Criteria:

* Diagnosed with or having a family history of any of the following concomitant psychiatric disorders: schizophrenia or prodromal symptoms, any bipolar disorder, obsessive compulsive disorder, or other psychotic episode. Recent (within last 12 months) diagnosis of a major depressive disorder (MDD) (HAM-D score \>19), treatment resistant depression (TRD), post-traumatic stress disorder (PTSD), panic disorder, or eating disorders.
* Subjects deemed unfit for psilocybin-assisted therapy based on the assessments made during psychotherapy sessions prior to the first psilocybin-assisted psychotherapy session.
* History of hallucinogen use disorder, or any use in the past 1 year, or \>25 lifetime uses.
Food Supplements Based on Nettle and Peppermint to Control Signs and Symptoms Induced by Cancer Therapies

The main purpose of this study is to evaluate the impact of food supplements (herbal remedies) on sign and symptoms induced by cancer therapies: Nettle will be administered for improvement of anemia and fatigue; Peppermint will be administered for improvement of nausea. Secondary aims of the trial are to evaluate the impact of these supplements on the quality of life and to evaluate their tolerability profile.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female ≥ 18 years
* Karnofsky Performance Scale (KPS) ≥ 90%
* Breast or Gynecological cancer
* Informed consent signed before every procedure study specific, on day 1 of therapy cycle
* Inclusion Criteria Arm 1: presence of grade 1 anemia as per CTCAE 4.0 criteria; patients on treatment with anti-CDK 4/6 or PARP Inhibitors or in adjuvant therapy with hormone therapy
* Inclusion Criteria Arm 2: presence of fatigue of any grade; patients on treatment with Epirubicin and Cyclophosphamide or Carboplatin and Taxane
* Inclusion Criteria Arm 3: presence of nausea of any grade, without vomiting; patients on treatment with Epirubicin and Cyclophosphamide or Carboplatin and Taxane

Exclusion Criteria:

* Arm 1, 2 and 3: Previous intake of food supplements within 4 weeks from the enrollment
* Arm 2: patients with evidence of anxiety or anxious-depressive syndrome; Clinical hypothyroidism not compensated by replacement therapy; Persistent insomnia
* Arm 3: patients with evidence of anxiety or anxious-depressive syndrome
Study on Treatment of Pegylated Interferon Alfa 2a(Pegasys®) in the Korean Chronic Hepatitis B(CHB) Adults

Patients will receive Peginterferon alfa-2a according to the standard medical practice but the observation period is 12 weeks


Eligibility Criteria:
Inclusion Criteria:

* History of HBsAg positive for more than 6 months
* HBeAg-positive or HBeAg-negative within 8 weeks
* Serum AST or ALT ≥ 80 IU/L
* HBe-Ag positive patients: Serum HBV DNA ≥ 1.0 X 10\^5 copies/mL (or 20,000 IU/mL)
* HBeAg-negative patients: serum HBV DNA ≥ 1.0 X 10\^4 copies/mL(or 2,000 IU/mL)

Exclusion Criteria:

* History of antiviral therapy for Chronic hepatitis B within 6 months of study enrollment
* Prior treatment of interferon
* Presence of viral coinfections (hepatitis C, hepatitis delta, or human immunodeficiency virus)
* Other chronic liver disease or decompensated liver disease
* platelet\<90,000/mm3 or absolute neutrophil count \< 1,500 mm3
* Pregnant or lactating woman
* History of Organ transplantation
* Treatment with immunosuppressive/immunomodulatory agents within 6 months prior to study entry
Alfuzosin for Treating Acute Urinary Retention

The primary objective of the study is to assess the efficacy of alfuzosin 10mg daily in the return to successful voiding after removal of the catheter following a first episode of acute urinary retention (AUR) in patients suffering from benign prostatic hyperplasia (BPH).


Eligibility Criteria:
Inclusion Criteria:

* First episode of painful AUR related to BPH requiring catheterization
* Residual volume between 500ml and 1500ml obtained at the time of catheterization and during the first one hour after catheterization

Exclusion Criteria:

* Participated in another investigational study within 3 months before recruitment
* Suspect bladder neuro-dysfunction unrelated to etiology;
* Single Bladder neck disease;
* Acute/chronic prostatitis;
* Diagnosed prostate carcinoma;
* Suspected prostate carcinoma diagnosed by ultrasound wave;
* Surgical history of prostate and urethra;
* Diagnosed/suspected abnormality in urethra structure;
* Bladder stone;
* Blood urine retention caused by any reason;
* Residual volume less than 500 ml
* Residual volume more than 1500 ml
* AUR not due to BPH
* Parkinson's disease
* Insulin dependent diabetes
* Known/suspected multiple sclerosis;
* Stroke/MI within 6 months prior to enrolment;
* AST, ALT and Creatinine \> 1.5x upper limit; neutrophil \< 3,000/mm³; platelet \< 100,000/mm³;
* Unstable/severe heart failure;
* History of postural hypertension/hypotension;
* Known hypersensitivity to α-receptor blocker;
* Suspected/diagnosed expansible nerval disease;
* Treatment with sympathomimetic agent within 1 week prior to enrolment, except OTC drug for cold intermittently;
* Treatment with α1-receptor blocker within 1 month prior to enrolment;
* Treatment with tricyclic antidepressants, anticholinergic agents, sympathomimetic agent (other than the above reason), first generation antihistaminic, except the treatment with stable β sympathomimetic agent/ anticholinergic agents lasting more than 1 week for Asthma and COPD (Chronic Obstructive Pulmonary Disease);
* Treatment with Disopyramide

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Negative Pressure Wound Therapy-PICO: Cosmesis in Repeat C-Sections

There are millions of births each year with 32% of women undergoing cesarean sections (C-sections), which results in skin scarring. Repeat C-sections increased by 178% from 1979-2010. Given the frequency of C-sections, it is important to achieve a desirable cosmetic outcome.

The PICO 7 dressing consists of a negative pressure wound therapy pump (NPWT) connected to an absorbent gentle adhesive dressing that is applied to a wound. When the pump is activated, it acts by pulling excess fluid from the wound. The dressing absorbs this fluid and helps to prevent bacteria from entering the wound. It has been shown to prevent wound infections and promote healing. This study aims to compare the aesthetic appearance by using The Patient and Observer Scar Assessment Scale (POSAS) scar assessment scale following closed incision negative pressure therapy with a PICO 7 dressing to the standard abdominal dressing in women undergoing repeat cesarean sections

Single, randomized controlled trial in women undergoing a repeat cesarean delivery. Women will be randomized to placement of a PICO 7 dressing or a standard abdominal dressing at the time of cesarean. The standard abdominal dressing will be removed approximately on postoperative day (POD) 1-2 and the PICO 7 dressing will be removed approximately on POD 3-4 (prior to discharge). If the patient with a PICO dressing remains inpatient for longer than 7 postoperative days, the PICO dressing will be removed prior to POD 7, in accordance with device instructions. Participants in both groups will be sent POSAS surveys at the two, four and six week visit window with primary outcome being aesthetic appearance (cosmesis) at six weeks. Observers (healthcare providers) will complete a POSAS survey at the postpartum visit (\~4-6 weeks postoperative) to rate scar quality.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled or non-labor repeat cesarean delivery
* One or more prior cesarean section(s) with prior pfannenstiel incision scar
* Gestational age \> 23 weeks
* Age 18 and older

Exclusion Criteria:

* Patients with malignancy in the wound bed or margins of the wound
* Non-enteric and unexplored fistulas
* Necrotic tissue with eschar present
* Exposed arteries, veins, nerves or organs
* Exposed anastomotic sites
* Cellulitis or evidence of active infection
* Known allergy to adhesive tape
* Patient unwilling to follow-up
* Contraindication to NPWT

  * Bleeding disorder
  * Therapeutic anticoagulation
  * Allergy to any component of the dressing (perhaps list these as you will need to know to confirm eligibility of each patient)
  * Prior irradiated skin
Manually Assisted Cough Technique and Incomplete Cervical Spine Injury

To determine the effectiveness of manually assisted cough technique on peak cough flow and pulmonary functions in patients with incomplete cervical spine injury. Previous studies were designed to target only a small sample. Level and American Spinal Cord Injury Association (ASIA) scale were not specified so this study covers this aspect.

The previous studies show that the partial control of the muscle necessary for cough, which varies with motor level, proportionately improves the patient's ability to cough volitionally. Spinal cord injury also affects mucus clearance, the peak flow meter was used to assist the ability of cough and they also measure the peak cough flow (PFC).In the literature for the airway clearance, the following techniques were used, incentive spirometer, balloon, and blowing exercise, manually assisted cough technique active cycle of breathing exercise, postural drainage, autogenic drainage, positive expiratory pressure. There is increasing interest in strategies such as interval training that may provide a tolerable training load while maintaining an effective stimulus for adaptation. Manually assisted cough technique is used to enhance the cough strength, to help with mucus secretion it can be carried out in lying, side-lying, or sitting positions.it is important that clear secretion in order to maintain clear and healthy lungs, the risk of repeated chest infection and complication can be reduced which improve the quality of life. Manually assisted cough is a technique using strong arms to assist cough. This may be providing help in neuromuscular disease or spinal cord injury with weak respiratory and abdominal muscle.

Eligibility Criteria:
Inclusion Criteria:

* The patient with incomplete cervical spine injury at C4, C5,
* bronchitis,
* shortness of breath having Peak cough flow (PCF) less than 50% and
* ASIA impairment scale C \&D

Exclusion Criteria:

* The patient with upper cervical,
* thoracic, and
* lumbar spine injury,
* diagnosed with TB,
* degenerative diseases,
* surgical conditions, and
* complete spinal cord injury.