cyrilzakka/clinical-trials huggingface dataset:
Managing Acute Schizophrenia, a Comparison Between Two Atypical Antipsychotics

The purpose of this study is to examine whether olanzapine, compared to risperidone, can provide more adequate and timely control of behavioral agitation in acutely ill subjects with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, aged 18 - 60
* Subjects must meet a clinical diagnosis of schizophrenia, schizophreniform disorder, or schizoaffective disorder according to DSM-IV
* Subjects' illness must not, in the opinion of the investigator, be caused by substance abuse
* BPRS total score (1 to 7 scale) of greater than or equal to 36 at visit 1
* Subjects must have a minimum total score of greater than or equal to 14 on the five items of the PANSS-EC and at least one individual item score of greater than or equal to 4 using the 1-7 scoring system prior to first dose of double-blind medications

Exclusion Criteria:

* Treatment with antipsychotics or benzodiazepines within 4 hours prior to the first study drug administration
* Treatment with an injectable depot neuroleptic within 1 injection interval prior to study drug administration
* Electroconvulsive therapy (ECT) within 1 month (90 days) prior to study entry (visit 1)
* Treatment with remoxipride within 6 months (180 days) prior to visit 1
* Documented history of allergic reaction to study medications
A Study To Investigate GW274150 Or Prednisolone In Rheumatoid Arthritis Taken Repeatedly For 28 Days.

This is an exploratory study to examine the effect of iNOS inhibition in rheumatoid arthritis patients. The study involves 28 days repeat dosing with GW274150 (dose determined by the results from a previous study), prednisolone (7.5mg) or placebo.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of rheumatoid arthritis according to the revised 1987 criteria of the American College of Rheumatology
* Female subjects who are not capable of becoming pregnant
* Active disease defined as Disease Activity Score (DAS) 28 = 4.0 and at least one metacarpal-phalangeal finger (MCP) joint with either detectable vascularity or thickness
* Stable doses of disease modifying anti-rheumatic drugs (DMARDs), (which can include but is not restricted to methotrexate, sulphasalazine and hydroxychloroquine in any combination) for 8 weeks prior to enrollment
* Patients receiving methotrexate must be on stable folate supplements
* Must have been on stable doses for 2 weeks prior to screening if using COX inhibitors
* Signed consent form
* The patient is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions

Exclusion criteria:

* The subject is using, or has used, oral glucocorticoids within 8 weeks of enrollment
* The subject is currently receiving anti-rheumatic biological therapy (e.g. infliximab, adalimumab, etanercept or anakinra)
* The subject received their final dose of infliximab or adalimumab within 3 months of enrollment
* The subject received their final dose of etanercept or anakinra within 1 month of enrollment
* The subject has received another investigational drug within 30 days
* The subject drinks more than 28 units (male) or 21 units (female) of alcohol in a week
* History of liver or renal disease in the 6 months prior to screening
* The subject has a history of drug or other allergy
* Subject is positive for Hepatitis B and C or HIV virus
* The subject has positive pregnancy test
* The subject has positive test for drugs of abuse
Impacts of Remote Digital Support on Physical Activity for Patients in Bariatric Surgery

Compare the level of PA (physical activity) in groups with and without STIMUL device at 4 months

Regular physical activity (PA) is a key element in the success of bariatric surgery and the prevention of complications associated with frequent co-morbidities. However, the levels of PA observed in patients who will benefit from bariatric surgery are generally low, and many patients do not comply with the recommendations of their course in terms of PA. It is envisaged that coaching interventions and adapted programs can improve the level of PA. The objective of this pilot study is to evaluate the effectiveness and adherence to digital tools on the level of PA in preparation for bariatric surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 30 to 50 years.
* Candidate for bariatric surgery within 4 to 6 months of inclusion: BMI \>40 kg/m² or BMI 35-40 kg/m² with obesity-related comorbidity
* Ability to follow the STIMUL education program focused on adapted physical activity
* Has and knows how to use a computer connected to the Internet or mobile phone
* Ability to understand, read and write French

Exclusion Criteria:

* • Contra-indication to the practice of sport

  * refusal to participate in the study
  * refusal to participate in the study
Traumeel® S in Preventing and Treating Mucositis in Young Patients Undergoing Stem Cell Transplantation

RATIONALE: Traumeel® S (a mouth rinse) may be effective in preventing or decreasing the severity of oral mucositis caused by chemotherapy in young patients who are undergoing stem cell transplantation.

PURPOSE: This randomized clinical trial is studying how well Traumeel® S works in preventing or treating mucositis in young patients who are receiving chemotherapy with or without total-body irradiation before undergoing stem cell transplantation.

OBJECTIVES:

* Compare the efficacy of Traumeel® S vs placebo in reducing the severity and duration of chemotherapy-induced (with or without total body irradiation) mucositis in pediatric patients undergoing hematopoietic stem cell transplantation.
* Determine the safety of this drug in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to treatment with total body irradiation during conditioning chemotherapy (yes vs no), type of transplantation (autologous vs allogeneic), and participating institution (COG vs foreign). Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral Traumeel® S mouth rinse 5 times daily beginning on day -1 before transplantation.
* Arm II: Patients receive oral placebo mouth rinse 5 times daily beginning on day -1 before transplantation.

In both arms, treatment continues until day 20 post-transplantation OR until mucositis resolves to Walsh score ≤ 1 for 2 consecutive days.

Patients are followed until day 100 post-transplantation.

PROJECTED ACCRUAL: A total of 180 patients (90 per treatment arm) will be accrued for this study within 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Planned treatment with allogeneic or autologous hematopoietic stem cell transplantation

  * Conditioning chemotherapy regimen for transplantation must be myeloablative
  * Source of stem cells from any of the following:

    * Bone marrow
    * Placental cord
    * Cytokine-mobilized peripheral blood
* Availability of 1 of the following donor types:

  * HLA-matched sibling or parent
  * Related donor mismatched for a single HLA locus (class I or II)
  * Unrelated marrow or peripheral blood stem cell donor
  * Unrelated umbilical cord blood HLA-matched or mismatched (class I) donor

PATIENT CHARACTERISTICS:

Age

* 3 to 25

Performance status

* Not specified

Life expectancy

* Not specified

Hematopoietic

* Not specified

Hepatic

* Not specified

Renal

* Not specified

Other

* No known allergy to Echinacea
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

* See Disease Characteristics

Chemotherapy

* See Disease Characteristics

Endocrine therapy

* Not specified

Radiotherapy

* Not specified

Surgery

* Not specified

Other

* No concurrent oral vancomycin paste
* No concurrent oral glutamine supplementation
* No other mouth care or oral medications within 30 minutes after administration of study drugs
* No other concurrent treatment to prevent mouth sores
WEMR With Clinical Decision Support for Diabetic Foot Ulcers

The goal of this project to begin using a wound research database with clinical decision support features at Winthrop University Hospital. A research database is an electronic computer system that is used to collect patient information. Clinical decision support is the ability for a computer system to provide medical assistance to the doctor through alerts and recommendations based on the information entered. The investigators believe that use of a wound clinical decision support tool, much like a drug, will improve healing in patients diagnosed with Diabetic Foot Ulcers and ultimately lower the risk of death and illness caused by these wounds. In order to develop a useful clinical decision support tool, investigators first need to develop a large research database to determine the data points important for wound healing. The investigators will be using the data collected in this study for future research and publication. Data will be reviewed to answer questions important to diabetic foot ulcer healing and for the purpose of developing the clinical decision support alert system.

After providing informed consent, participants will be asked a series of questions related to their past medical history, and relevant wound data will be collected. Study staff will photograph the wound at baseline, and once per week until the wound is completely healed, or for a duration of six months.

Participants will be expected to return to Winthrop University Hospital for wound follow-up on a regular basis, or as determined by the Principal Investigator.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 21
* Diabetes Type I, or Type II
* Must have a break in the skin on the plantar aspect of foot, \> 0.5cm2
* Willing and able to provide written Informed Consent

Exclusion Criteria:

* None
PET FDG Assessment of Change in Atherosclerotic Plaques After Chemotherapy

The purpose of this study is to determine whether chemotherapy induces regression in atherosclerotic plaques in oncologic patients already undergoing PET FDG as part of their routine assessment.We will use PET FDG to assess whether the inflammation in atherosclerotic plaques is affected by chemotherapy and anti angiogenic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Women over the age of 65 diagnosed with metastatic breast cancer
* Men over the age of 65 diagnosed with lung cancer

Exclusion Criteria:

* Patients under the age of 65
* Patients diagnosed with chronic inflammatory disease or chronic infection
* Patients taking steroids and NSAIDS on a regular basis
Hemorrhoidectomy Only Versus Hemorrhoidectomy With Lateral Internal Sphincterotomy

The aim of this study was to access the comparison of pain and complications after hemorrhoidectomy with or without lateral sphincterotomy.

Hemorrhoids arise from congestion of anal cushions and characteristically lie in the 3, 7 and 11 O clock positions (with the patient in lithotomy position) . The most common complication of open hemorrhoidectomy is postoperative pain caused by spasm of the internal sphincter . Lateral internal sphincterotomy is one good technique. It reduces pain by reducing spasm of internal anal sphincter which is the main cause of pain . The addition of lateral internal sphincterotomy to haemorrhoidectomy resulted in generally lower postoperative anal pressures . The long-term outcomes, which included anal stenosis and anal fissure, were significantly lower after lateral internal sphincterotomy . patients with recurrence of hemorrhoids, severe pain, prolonged constipation, or anyone with high sphincter tonicity in the digital rectal examination would be a candidate for manometric evaluation of anal canal pressure. These patients with high analcanal pressure confirmed with manometry might receive internal sphincterotomy plus hemorrhoid-ectomy .

Eligibility Criteria:
Inclusion Criteria:

1. Surgically fit according to ASA.
2. Cases with hemorrhoids Grade ll\& III \& IV.
3. Age between (18-60).

Exclusion Criteria:

1. Age less than 18 years old.
2. Complete rectal prolapse.
3. Grade I hemorrhoids.
Diabetic Mellitus Patients Glucose Range Awareness After Experiencing a New Blood Glucose Meter Feature

A single visit \& single arm study in 80 subjects with diabetes to determine if a short educational experience with a new blood glucose meter feature improves the ability of each subject to better classify glucose results into acceptable glucose ranges.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Type 1 diabetes Mellitus (T1DM) or Type 2 diabetes Mellitus (T2DM) for ≥ 3 months
* Currently performing self monitoring of blood glucose (SMBG) at home
* Aged ≥16 years

Exclusion Criteria:

* Previous use of any blood glucose meter with the colour range indicator feature to be evaluated in this study.
Efficacy, Safety and Tolerability of AFQ056 in Fragile X Patients

This study will evaluate the safety, tolerability and efficacy of multiple doses of AFQ056 in patients with Fragile X Syndrome. The dose range will be 50 to 150 mg b.i.d. The primary read-out of efficacy is reduction in Aberrant-Behavior Checklist score.


Eligibility Criteria:
Inclusion Criteria:

* Male, non-smoking patients between 18 and 35 years of age (both inclusive).
* Patients with fmr1 full mutation (\> 200 CGG repeats)
* Patients with a Clinical Global Impression Severity Score (CGI-S) of \> 4 (moderately ill)
* Patients with a score of \>20 in the ABC-C scale (at screening)
* Patients with a mental age of ≥ 48 months as measured by the Stanford-Binet test

Exclusion Criteria:

* Patients with DSM-IV diagnosis of schizophrenia, history and/or presence of psychosis, confusional states and/or repeated hallucinations.
* Patients with a history of seizures in the past 5 years without any therapeutic treatment controlling the disorders.
* Patients under stable anti-convulsant therapies that experienced seizures in the 2 years prior to randomization
* Patients with ECG abnormalities, autonomic dysfunctions, bronchospastic diseases, drug or atopic allergy
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs
* Patients using (or have used within four weeks before randomization) concomitant medications that are potent inhibitors of CYP3A4 (e.g., ketoconazole, ritonavir, etc.)

Other protocol-defined inclusion/exclusion criteria may apply.
Modification of Cerebral Activity of Obsessive Compulsive Disorder (OCD) Patients During Cognitive and Behavioral Therapy

Obsessive compulsive Disorder (OCD) is a frequent psychiatric disorder. Obsessions and compulsions are the two manifestations of this disease. Obsessions are recurrent anxious ideas, and compulsions repetitive behavior aiming to decrease this anxiety.

OCD symptoms have been associated with cortical and sub-cortical dysfunctions and more precisely an hyperactivity of prefrontal cortex / basal ganglia loops.

Functional neuro-imagery studies have shown a significant decrease of orbito-frontal cortex, anterior cingulate cortex, caudate nucleus and cerebellum activities after two OCD reference treatments : medication and Cognitive and Behavioral Therapy (CBT).

Two groups of 20 patients are included in this study and follow a CBT for 15 sessions. They are randomised in two groups : one proposing a "reference CBT", the other associate CBT to a new psychopedagogic task developed by the investigators team.

Clinical investigations and neuro-imagery data are collected at the main steps of therapies : before, during (half-therapy), at the end of therapies and 6 month later. Symptoms severity, patients and relatives quality of life are also assessed.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65;
* Following Obsessive Compulsive Disorder criteria according to DSM IV(300.3 ;MINI 5.0.0);
* OCD severity range from 20 to 30 on the Y-Brown obsessive compulsive scale;
* Having checking symptoms;
* Understanding and accepting the study;
* Giving his written informed consent to the study.

Exclusion Criteria:

* Claustrophobia;
* Cerebral abnormality;
* Chronic absenteism to CBT (more than 5 missed sessions during the whole therapy).

In case of exclusion of the study either decided by the patient himself or by the investigator, a debriefing is proposed by a psychologist.
Efficacy and Safety Assessment of Niacinamide Cosmetic Preparation: a Randomized Controlled Trial

Niacinamide in lower concentrations has been recognized as a cosmetic ingredient with hydrating properties. Therefore, aim was to test the efficacy and safety of niacinamide cosmetic preparation in A Randomized, Controlled Trial.

Skin hydration (as use of hydrating cosmetic ingredients) is one of the most interventions for healthy skin and skin barrier function. Therefore, cosmetic ingredients used for this purpose should be examined for their efficacy.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers who gave written informed consent

Exclusion Criteria:

* skin disease, skin damage on measurement sites, use of corticosteroids and immunomodulators a month prior to the inclusion and during the trial, non-adherence to the trial protocol, exposure to artificial UV radiation, pregnancy and lactation
The Relationship Between Prolonged Hospitalization and Surgical Experience in Pediatric Tonsillectomy Cases.

Guided by the expertise of a seasoned surgeon at the tertiary care hospital, the training program includes performing tonsillectomy starting from the 6th month. The clinical protocol at the hospital dictates a standard one-night hospital stay for all patients, but there is potential to extend the duration in specific cases. The study endeavors to explore the correlation between extended hospitalization, surgical proficiency, patient-specific factors, and postoperative complications in pediatric patients who underwent tonsillectomy and/or adenotonsillectomy at the clinic.


Eligibility Criteria:
Inclusion Criteria:

* Patients under 18 years of age having tonsillectomy surgery
* Patients whose records are available in the hospital archive

Exclusion Criteria:

* Inadequate information in files
Total-body 13N-NH3 PET/CT to Study the Blood Perfusion in Whole Body

The aim of our study is to analyze and quantitate whole-body blood perfusion by total-body 13N-NH3 PET/CT(uEXPLORER), and evaluate the influence to other organs caused by the decreased cardiac function.

Participants are invited to participate in a research that seeks to understand the dynamic blood perfusion in human body. The investigators expect to have twenty-five participants in this study at Renji Hospital, Shanghai. About sixteen of the participants will be patients who have been diagnosed with decreased cardiac function, nine participants will be healthy individuals with no known vascular disease. These healthy subjects will allow researchers to compare blood perfusion difference with those of persons with decreased cardiac function. All the participants will undergo the same procedure.

If participants agree to participate in this study, researchers will first interview participants and review the past medical record in order to document the medical history. When the screening procedures confirm that participants are eligible to participate in the study, participants will receive one dose of the non-therapeutic administration of a radioactive tracer called N-13 ammonia(13NH3) , then undergo one total body 13NH3 PET/CT Scan (uEXPLORER) to determine the blood flow value of the brain, kidney and other organs. The total body 13NH3 PET/CT Scan will allow investigators to observe and analyze the real-time blood flow differences between patients with between healthy controls and decreased cardiac function.

Eligibility Criteria:
Inclusion Criteria:

* Nine healthy volunteers with normal EF values
* Patients with decreased cardiac function, while their heart function grading above II(New York Heart Association,NYHA)
* Aged 60\~90 years old
* Written informed consents will be offered and signed by all participants

Exclusion Criteria:

* History of vascular-related diseases in other organs
* Severe liver and kidney dysfunctions
* Patients who are pregnant or breast feeding
* People under the age of 60 years old
* Heart function grading below II(NYHA)
* inability to lie or to maintain posture in the scanner for one hour
AZD7325 Multiple Ascending Dose Study

This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD7325 after single and repeated ascending doses.


Eligibility Criteria:
Inclusion Criteria:

* Female subjects must be of non-child bearing potential.

Exclusion Criteria:

* Clinically significant illness within 2 weeks before the study start.
* Enrollment in another concurrent investigational study or intake of an investigational drug within 30 days or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit
* Blood loss in excess of 200 mL within 30 days of Day -2, in excess of 400 mL within 90 days of Day -2, or in excess of 1200 mL within 1 year of Day -2
* Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis
Efficacy of Nasal Oxygen Therapy to Reduce Postoperative Complications in Ankle Trauma Surgery in At-risk Patients: a Randomized Pilot Study.

Ankle fractures are one of the most common surgeries in the world. After this kind of surgery, complications can occur, related to the scar or an infection. These complications are more frequent in "high-risk" patients. Nasal oxygen therapy is currently used in order to reduce these complications. However, no study proved its efficiency yet. In a cohort of 200 patients, one group will receive oxygen therapy during hospitalization, while the other will not. Complication rates will be observed up to 6 months after the operation

Prospective, single-center, comparative and randomized study based on a cohort of 200 patients with an ankle fracture. The patients will be assigned to one of the following group: with or without oxygen therapy. Patients in the experimental group will receive the oxygen just before the operation, and during the hospitalization. The rest of the care is the same for the 2 groups. Comparison of complication rate, of quality of healing, rate of revision surgery, delay in bone healing, rate of pseudoarthrosis, and ankle pain will be done between the 2 groups during a postoperative period of 6 months. A cost-utility analysis will also be realized. In a subgroup of 40 patients, additional transcutaneous oxygen pressure measurements will be performed to compare the evolution of tissue oxygenation between the 2 groups.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years of age
* Patient with an ankle joint injury with surgical indication
* Patient with at least one risk factor for scar complication such as comorbidity(ies) (diabetes, smoking, peripheral neuropathy, obstructive arterial disease of the lower limbs, microangiopathy, treatment influencing healing (chemotherapy, corticosteroids...)) and/or complex fracture
* Patient affiliated to a social security system
* Patient having signed an informed consent

Exclusion Criteria:

* Patient with chronic respiratory insufficiency
* Patient with sleep apnea with equipment
* Patient under long term oxygen therapy
* Patient with a bilateral ankle fracture
* Polytrauma patients
* Pregnant or breastfeeding women or those refusing effective contraception
* Patient deprived of liberty or under legal protection (guardianship or curatorship)
* Patient unable to follow the protocol, as judged by the investigator
* Patient refusing to participate in the study