cyrilzakka/clinical-trials huggingface dataset:
Arsenic Trioxide in Treating Patients With Multiple Myeloma

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

PURPOSE: Phase II trial to study the effectiveness of arsenic trioxide in treating patients who have relapsed or refractory stage II or stage III multiple myeloma.

OBJECTIVES: I. Determine the response rate of patients with relapsed or refractory stage II or III multiple myeloma treated with arsenic trioxide. II. Determine the overall and relapse-free survival rates of patients treated with this drug. III. Determine the safety profile of this drug in these patients.

OUTLINE: Patients receive arsenic trioxide IV on days 1-5 and 8-12. Treatment repeats every 4 weeks for up to 6 courses. Patients are followed at 4 weeks after the last treatment dose.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Diagnosis of multiple myeloma Stage II or III (Durie-Salmon) Relapsed or refractory to conventional therapy No monoclonal gammopathy or indolent or smoldering myeloma Measurable disease by serum and urine M protein and/or plasmacytoma

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 70-100% Life expectancy: 3 months Hematopoietic: Granulocyte count greater than 1,200/mm3 Platelet count greater than 100,000/mm3 Hemoglobin greater than 10 g/dL Hepatic: Bilirubin less than 2 times upper limit of normal (ULN) SGOT/SGPT less than 2 times ULN Renal: Creatinine no greater than 2.5 mg/dL Cardiovascular: Absolute QT interval less than 460 msec in the presence of normal potassium and magnesium levels

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 28 days since prior biologic therapy Chemotherapy: No more than 3 prior chemotherapy regimens, including no more than 2 cytotoxic regimens AND 1 high-dose cytotoxic regimen as part of stem cell transplantation Endocrine therapy: At least 28 days since prior endocrine therapy Radiotherapy: At least 28 days since prior radiotherapy (except for focal radiotherapy for symptom control) Surgery: Not specified
Dissociative Disorders in Obesity (Dissobe)

THe aim of this study is to determine the frequency of dissociative tendencies in the obese population treated at the CELIOBE (Liberal Center for Obesity Support) at Hôpital Privé La Louvière among patients consulting for the first time and looking for a medical or surgical course. The DES scale of Carlson and Putman will be used.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Obesity defined by a Body Mass Index (BMI) ≥ 30 kg / m2
* Patient seen in consultation at CELIOBE for the first time for the management of an overweight problem, wishing for surgical or medical care
* Patient having been informed and not opposing to this research
* Patient affiliated or beneficiary of a social security scheme

Exclusion Criteria:

* Psychotic antecedents: Schizophrenia, Schizoaffective disorders, Hallucinatory psychoses, Brief psychotic attacks
* Addictive behaviors (alcohol, drug addiction)
* Drug use
* Taking antipsychotics and mood stabilizers
* Dissociative identity disorders proven
* Bipolar disorders or severe mental illness
* Understanding troubles
* Protected patient: Major under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision; Hospitalized without consent
* Pregnant, breastfeeding or parturient woman
Acceptability, Gastro Intestinal Tolerance Compliance of a Paediatric Tube-feed Formula Derived From Food for Children

This is an acceptability study to evaluate the gastrointestinal tolerance and compliance over a seven-day period, of pediatric formula for the dietary management of participants with short bowel syndrome; intractable malabsorption; preoperative preparation of undernourished patients; inflammatory bowel disease; total gastrectomy; dysphagia; bowel fistulae; feeding intolerances, developmental disabilities, disease related malnutrition The acceptability data from 15 participants will be collected in order to submit an application to the Advisory Committee on Borderline Substances (ACBS).

Patients well established and stable on a standard enteral tube feed will be changed to a paediatric formula for a period of seven days. This group will act as their own controls. Each child will receive for a period of seven days the paediatric formula, a nutritionally complete standard enteral tube feed.

The dietitian will determine the feeding regimen on an individual basis and the enteral formula will be provided via a feeding tube. A baseline questionnaire will be completed by the dietitian to ensure eligibility of study, current stool patterns or symptoms, current oral intake and weight at the start of the study.

The parents will complete a week intake chart to monitor how much feed has been consumed each day and a tolerance diary to review gastrointestinal symptoms at the start and end of the study.

Eligibility Criteria:
Inclusion Criteria

* Require a tube feed (taking \>75% of energy needs from their feeding tube) as part of their dietary management for disease related malnutrition
* Paediatrics aged 1 year above.
* Patients well established and stable on a standard or peptide enteral formula (no gastrointestinal intolerances on current formula)
* Willingly given, written, informed consent from patient or parent/guardian.
* Willingly given, written assent (if appropriate).

Exclusion Criteria

* Inability to comply with the study protocol, in the opinion of the investigator
* Known food allergies to any ingredients (see ingredients list)
* Patients with significant renal or hepatic impairment
* Change in current medication or use of additional macro/micronutrient supplements during the study period, unless clinically indicated and prescribed by the investigator (must be recorded in patient case record file).
* Participation in another interventional study within 2 weeks of this study
Evaluate the Efficacy of a Global Dental Health Promotion Program on Dental Hygiene in Patients With Schizophrenia.

There are few disease prevention programs or programs to manage somatic disorders in a psychiatric context. The aim of this study is to evaluate the impact in the medium term of a global program to promote dental health on buccodental hygiene in patients with schizophrenia and the ability of these patients to follow the intervention.

This is an interventional trial, randomized in clusters. The participating establishments will be randomized to the "intervention" group (promotion program) or the "control" group (surveillance).

For each patient, the study will last 12 months altogether and will include an initial evaluation of dental health, a 6-month education program for dental care (for patients in the "intervention" group) and a follow-up at 6 and 12 months after the start of the study. The follow-up will evaluate dental health and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a confirmed diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM V)
* Managed at a specialized establishment
* Older than 18 years.
* who have provided written informed consent to take part in the study

Exclusion Criteria:

* Fully hospitalized patients
* Patients who are unstable from a psychiatric poit of view or who suffer from delirium.
* Subjects with less than one incisor, canine, premolar and molar on each hemi-arch
* Patients with a risk of infectious endocarditis or a major risk of superinfection
* Patients on long-term treatment with antibiotics (Impact of antibiotherapy on oral flora)
* Patients treated with chemotherapy
* Pregnant or breastfeeding women
* Patients without National Health Insurance cover.
* Poor written and/or oral comprehension of the French language
Treatment of Marijuana Withdrawal Syndrome Using Escitalopram and Cognitive-Behavior Therapy

Recent studies have established the reliability, validity and time course of the cannabis withdrawal syndrome. This study will investigate the effects of combined treatment of Escitalopram with cognitive-behavior therapy in alleviating the symptoms of the marijuana withdrawal syndrome in regular chronic users of marijuana. We predict that combined pharmacological treatment and cognitive-behavior therapy will help patients to abstain from using using marijuana and it will alleviate their marijuana withdrawal symptoms.

Recent studies have established the reliability, validity and time course of the cannabis withdrawal syndrome characterized by symptoms of anxiety, irritability, negative mood, physical symptoms and decreased appetite. This study will investigate the effects of combined treatment of Escitalopram with cognitive-behavior therapy in alleviating the symptoms of the marijuana withdrawal syndrome in regular chronic users of marijuana. 40 patients will be blindly randomized to either active or placebo escitalopram 10mg/day, for 12 weeks followed bt 12 weeks of follow-up.

Inclusion criteria include:

* Men and women age 20-45
* DSM-IV diagnosis of THC dependence.

Exclusion criteria include:

* Dependence on other drugs or alcohol
* Bipolar Disorder or Schizophrenia, Major depression, suicidal ideation psychotic symptoms or violent thoughts
* Current treatment with anti-depressant medication
* Neurological disease
* Physical illness (hypothyroidism, severe anemia, renal failure)
* Past severe effects of SSRIs.

Outcome measures include:

* urine THC analysis every two weeks
* questionnaires assessing addiction severity index
* depression and anxiety.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 20-45
* DSM IV criteria of marijuana dependence.

Exclusion Criteria:

* Other drug or alcohol dependence
* Bipolar disorder, schizophrenia, major depression, suicidal ideation, psychotic symptoms or violent thoughts
* Physical illness including hypothyroidism, neurological disease, severe anemia, and renal failure
* Past severe side effects of SSRIs.
Endoscopic Resection of Gastric Subepithelial Masses, EndoResect Study

Gastric subepithelial masses might harbour gastrointestinal stromal tumors, which should get resected because of their malignant potential. To minimize the associated surgical trauma endoscopic endoluminal resection is favorable. Therefore in the current study endoscopic resection of gastric subepithelial masses is investigated. Since there is a certain risk of perforation due to the procedure, perforations get closed by placement of endoscopic clips (over-the-scope-clip \[OTSC\] clips).

During an initial pilot phase 8 patients receive endoscopic resection under laparoscopic control. Thereafter and after positive initial results sole endoluminal endoscopy is done for a total of 38 patients.

Eligibility Criteria:
Inclusion Criteria:

* Endosonographically suspicous gastric subepithelial mass \<=3 cm.

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) classes IV or V
* Pregnancy
* Bleeding disorders
* Contraindications for endoscopy
* Endosonographically shown large vessels in the area for resection
A Safety, Pharmacokinetic and Pharmacodynamic Study of ACP-001 (TransCon hGH) in Adults With Growth Hormone Deficiency

This study investigates the safety, tolerability, pharmacokinetic profile (PK), and pharmacodynamic response (PD) of three different doses of ACP-001 given once-a-week compared to one dose-level of an approved daily human growth hormone product over a period of 4 weeks (4 weekly administrations versus 28 daily administrations) in adults with Growth Hormone Deficiency.


Eligibility Criteria:
Inclusion Criteria:

* Male or female between 20 to 70 years
* Body Mass Index (BMI, kg/m2) of 19.0 to 36.0 kg/m2, both inclusive
* Adult Growth Hormone Deficient (AHGD) patients with documented growth hormone deficiency as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II (Consensus Guidelines 1998 and 2007)
* Fertile females must agree to use appropriate contraceptive methods and have a negative pregnancy test at inclusion
* GH replacement therapy for at least 3 months
* Willing to maintain current activity level during the trial
* Subjects are able and willing to provide written informed consent and authorization for protected health information disclosure in accordance with Good Clinical Practice (GCP)

Exclusion Criteria:

* History of hypersensitivity and/or idiosyncrasy to any of the test compounds or excipients employed in this study.
* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods. Reliable methods for women are orally administered hormonal contraceptives, surgical intervention (e.g. tubal ligation), intrauterine device (IUD) and sexual abstinence.
* Active malignant disease or malignant disease within the last 5 years
* Proliferative retinopathy judged by retina-photo within the last year
* Heart insufficiency as judged by the investigator and/or NYHA 3 or greater (NYHA criteria for diagnosis of diseases of the heart, 1994)
* Subjects with uncontrolled diabetes with an HbA1c above 8.0% and/or insulin treatment
* Stable pituitary hormone replacement therapy for less than 3 months
* Impaired liver function as judged by the investigator or hepatic transaminases \> 2 times the upper limit of normal
* Impaired kidney function as judged by the investigator and/or creatinine clearance \<50 mL/min and/or serum creatinine \> 1.4 mg/dL
* Participation in another interventional clinical study involving an investigational compound within 3 months prior to enrolment in this study or participation in another interventional clinical study involving an investigational compound during this study.
* Subjects who are unable to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study.
* History or presence of alcohol abuse or drug abuse.
* Patients with known history for, or presence of, anti-hGH and / or anti-PEG antibodies
Magnetic Resonance Imaging of Gynecologic Malignancies Involving the Vagina

The goal of this clinical research study is to learn if a type of MRI scan called diffusion weighted imaging (DWI) is accurate in checking the status of tumors. Researchers also want to learn if DWI can predict how tumors will respond to radiation therapy.

If you agree to take part in this study, information will be collected from your medical record including your age, sex, and status of the disease.

For the MRI scans, you will receive a routine contrast drug by vein. Contrast drugs are used by doctors in order to see MRI images more clearly.

A modified MRI scan will performed right after your scheduled standard-of-care MRI scan. This modified MRI scan is the investigational scan. To complete the modified MRI scan, you will need to stay in the MRI scanner for about 8 extra minutes. It should take about 47 minutes total to complete both scans.

The way that researchers program the MRI machine and the order in which the images are taken is what is being modified for the investigational scan. These changes may help researchers capture better images.

Length of Study:

Your participation on this study will be over after the modified MRI scan is complete.

This is an investigational study. The standard-of-care MRI scan method is FDA approved and commercially available for the diagnosis of several diseases. The modified MRI scan method is being used in research only.

Up to 25 participants will be enrolled in this study. All will take part at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. All patients who have gynecologic malignancies involving the middle third and the distal third of the vagina who will be receiving radiation therapy
2. Patients who have gynecologic malignancies involving the upper, middle and/or lower third of the vagina or are undergoing pelvic exenteration.

Exclusion Criteria:

1. Pregnant patients
2. Any implantable medical device that is not MRI compatible (e.g. pacemakers, defibrillators, pain pumps or insulin pumps)
BOTOX® for the Treatment of Platysma Prominence

To assess the efficacy and safety of BOTOX® in adults with moderate to severe platysma prominence.


Eligibility Criteria:
Inclusion Criteria:

* Female participants willing to minimize the risk of inducing pregnancy for the duration of the clinical study and follow-up period
* A female participant is eligible to participate if she is not pregnant (has a negative urine pregnancy result prior to randomization), not breastfeeding, and at least one of the following conditions applies:

  1. Not a woman of childbearing potential (WOCBP) OR
  2. A WOCBP who agrees to follow the studies contraceptive guidance during the treatment and follow-up period through study exit.
* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this study's protocol

Exclusion Criteria:

* Any medical condition that may put the participant at increased medical risk with exposure to BOTOX®, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other condition that might interfere with neuromuscular function
* Participant has an anticipated need for treatment with botulinum toxin of any serotype for any indication during the study (other than study intervention)
* Anticipated need for surgery or overnight hospitalization during the study
* Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study
* Females who are pregnant, nursing, or planning a pregnancy during the study
* Known immunization or hypersensitivity to any botulinum toxin serotype
* History of alcohol or drug abuse within 12 months of the study
* Participant has tattoos, jewelry, or clothing that cannot be removed, and that obscure the neck
Effects of Transcranial Direct Current Stimulation on Pain Control in Chronic Painful Total Knee Arthroplasty

The TSEF-PTG study aims to evaluate the effects of transcranial Direct Current Stimulation (tDCS) and exercise versus sham tDCS (placebo) and exercise on pain control in chronic painful total knee arthroplasty (TKA) patients.

The TSEF-PTG study is a single center, double blinded randomized controlled trial.

The aim is to evaluate the effects of a tDCS stimulation and exercise vs sham tDCS and exercise on pain control in chronic (lasting more than 3 months from the intervention) painful total knee arthroplasty (TKA) patients.

The participants will be randomized in two groups: intervention group (IG) and control group (CG).

The IG will receive a 20 minute program of active tDCS (2mA intensity, anode placed on primary motor cortex controlateral to the TKA, cathode placed on controlateral supraorbital region) followed by a 30 minute exercise program, 5 days a week, for 2 consecutive weeks.

The CG will receive a 20 minute program of sham tDCS (15 seconds of activation and then no stimulation, same position of IG) followed by the same 30 minute exercise program, 5 days a week, for 2 consecutive weeks.

The participants will be evaluated at T0 (enrolling), T1 (at the end of the program), T2 (at 1 month from the end of the program) and T3 (at 3 months from the end of the program).

The primary outcome is the variation of pain intensity, the secondary outcomes are the variation of knee function and of the quality of life.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* able to independently walk (with or without walk aids)
* chronic painful TKA (more than 3 months)
* Visual Analogic Scale for pain more than 3/10
* No cognitive impairments (MMSE\>24 or =24/30)

Exclusion Criteria:

* intracranial metal devices, pacemakers or any implantable devices
* cutaneous abnormalities on the stimulation sites
* epilepsy (past or present)
* neurological or psychiatric pathologies
* cognitive impairment (MMSE\<24/30)
* no opioids abuse (past or present)
* severe cardiopulmonary, renal or hepatic pathologies
* pregnancy
* known present TKA complications (e.g. infections, mobilization, etc...)
* pain therapy modifications in the last 1 month
Effectiveness and Safety of Therapy Based on Attenuated ATO Plus Low-Dose ATRA in Patients With APL

ATRA is the standard of care for all patients with APL. The use of lower doses of ATRA has been shown since the 1990s to achieve therapeutic efficacy with doses of 25mg/m2/day. ATO demonstrated considerable effectiveness in this disease. More recently, an attenuated regimen has been proven to be effective. In this study we intent to demonstrate the effectiveness of combined therapy of low-dose ATRA plus attenuated dose ATO.

The use of lower doses of ATRA has been shown since the 1990s to achieve therapeutic plasma concentrations sufficient to achieve therapeutic efficacy with doses of 25mg/m2/day. ATO alone demonstrated considerable effectiveness in this disease. More recently, an attenuated regimen has been proven to be effective in inducing similar remission rates and achieving prolonged survival, also demonstrating a reduction in associated toxicities, mainly hepatic and cardiac when using this new scheme.

The investigators will conduct a phase 1/2, non-randomized, single center, non-comparative clinical trial to demonstrate the effectiveness of combined therapy of low-dose ATRA plus attenuated dose ATO which is accessible to a population with limited resources while maintaining acceptable efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Both genders
* new diagnosis of APL
* Diagnosis of relapsed APL who have not been previously treated with ATO
* Morphological diagnosis of APL confirmed by PCR or FISH

Exclusion Criteria:

* Poor functional status (ECOG\>2)
* Organic dysfunction (Marshall score ≥2)
* Pregnancy
* Heart failure (NYHA III or IV)
* Renal failure (GFR \<30 ml/min/1.72m2)
* History of ventricular arrhythmias or uncontrolled arrhythmias
* Acute myocardial infarction, unstable angina, or stable angina in the last six months
* Uncontrolled active infection
* Liver disease (Child-Pugh C)