cyrilzakka/clinical-trials huggingface dataset:
Prevention of Disease Progression in Early Stage Indolent B Cell Malignancies. (SMM)

Escalating doses of Omega 3 Fatty Acids are being used in patients who have early stage Chronic Lymphocytic Leukemia (ES-CLL), Monoclonal Gammopathy of Undetermined Significance (MGUS), or Smoldering Multiple Myeloma (SMM), whose disease does not currently require treatment. The primary aim of the study is to determine if the Omega 3 supplementation will help prevent or delay progression of the disease to a stage that requires treatment.


Eligibility Criteria:
Inclusion Criteria:

* Must be over 18 years of age.
* Must be free of other medical conditions that would decrease life expectancy to less that 12 months.
* Must be free of Omega 3 supplements or other fish oil containing nutritional supplements for a minimum of two months prior to enrollment.
* Must have a ECOG performance status of 0,1 or 2.

Exclusion Criteria:

* Any life-threatening condition such as (but not limited to) advanced heart disease, kidney or liver failure with an expected survival of less than 12 months.
* Any other active malignancy.
* Women who are pregnant or lactating.
* Individuals unable to give informed consent.
* Individuals with known allergy or intolerance to fish oil supplements.
* Any patient with an active bleeding diatheses or disorder.
* ECOG performance status of 3 or 4.
Effects of Intraarticular Botulinum Toxin A in Ankle Osteoarthritis

The purpose of this study is to compare the effects of intraarticular Botulinum Toxin A versus intraarticular hyaluronate plus rehabilitation exercise in patients with ankle osteoarthritis.

Recent pilot studies report that intraarticular injection of Botulinum Toxin A into painful joints of patients with various types of arthritis leads to significant and durable improvement in pain and function and is safe to use. To date, there is no published literature that evaluate the effects of intraarticular Botulinum Toxin A in the treatment of ankle OA. Sun el al reported that 3 or 5 weekly injection of hyaluronate may improve pain and physical function in patients with ankle OA and the treatment effects may last for 6 months. The effect of one injection of hyaluronate plus exercise had never been studied. The purpose of this study is to compare the effects of intraarticular Botulinum Toxin A versus intraarticular hyaluronate plus rehabilitation exercise for patients with ankle OA.

Eligibility Criteria:
Inclusion Criteria:

* an age of 20-85 years with diagnosis of ankle osteoarthritis
* unilateral ankle pain that had lasted for at least 6 months, with no significant benefit from conservative treatment or with an inability to tolerate the side effects of medications
* ankle radiographs taken within 6 months equivalent to grade 2 on the Kellgren-Lawrence grading system
* a current total Ankle Osteoarthritis Scale (AOS) score of \>3 and \< 9 (possible range, 0-10)
* a normal activity level-i.e., not bedridden or confined to a wheelchair, and are able to walk 30 meters without the aid of a walker, crutches or cane
* no changes in shoes or orthotic devices during the study period.

Exclusion Criteria:

* pregnancy or lactation in women
* lower leg trauma other than ankle trauma
* previous surgery involving the spine, hip or knee
* the presence of an active joint infections of foot or ankle
* previous surgery or arthroscopy on the ankle within 12 months
* history of chicken or egg allergy
* intraarticular steroid or hyaluronate injection in the treated ankle within the previous 6 months
* treatment with anticoagulants or immunosuppressives
* a history of rheumatoid arthritis, gout, or any other inflammatory arthropathy
* the presence of other comorbidity (such as neoplasms, diabetes mellitus, paresis or recent trauma) or poor health status that would interfere with the clinical assessments during the study.
Cortical Excitability and Role of rTMS in Cannabis Use Disorder

Repetitive transcranial magnetic stimulation (rTMS) and cortical excitability have a role in cannabis use disorder


Eligibility Criteria:
Inclusion Criteria:

* 18to 50 years of age
* cannabis use disorder according to DSM 5 definition
* clear consent to participate in study

Exclusion Criteria:

* cardiac peacemaker
* metal implant in the head as participate will be applied to magnetic field of TMS
* current intake of any medication affect cognition (as anti psychotic and anti epileptic)
* current history of neurological , psychiatric or general medical disease .current or previous drug (other than cannabis )or alcohol abuse or participation in another trial during the past 8 weeks .
* age younger than 18 and older than 50 years
Improving Cesarean Section Experience Through Hypnotherapy

Cesarean section rates continue to increase worldwide, particularly in middle- and high-income countries. In France, the rate has now stabilized around 20 %. Cesarean section is a particular way of giving birth, sometimes desired, but sometimes feared. If some women do not feel affected by this way of giving birth, it is more difficult for others to live with. In this way, not being able to give birth trough natural way may be disturbing in motherhood. At La Rochelle hospital, more than 230 healthcare providers have been trained according to Erickson's hypnosis methodology. Among them, 40 are part of the anesthesia department and a committee oversees the hypnotherapist activities in pain management. The objective of the present study is to assess the benefit of hypnosis session for improving experience and reducing anxiety in women giving birth through surgery.

Nonpharmacological approaches for pain management, either as a primary method or as a complement to pharmacological approaches, are suggested for a better perinatal management. The investigators assessed the use of conversational hypnotic induction and therapeutic suggestions during cesarean section as a complement to pharmacological strategy. Women giving birth through scheduled or unplanned cesarean section and who accepted hypnotherapy session were compared to a control group.

Eligibility Criteria:
Inclusion Criteria:

* over 18
* scheduled or unplanned cesarean section
* Informed consent

Exclusion Criteria:

* Refusal of the patient to participate in the study
* Not French speaking
* Patients under guardianship
Ulcerative Colitis Study: Study of Visilizumab in Patients With Severe Ulcerative Colitis

The purpose of this study is to evaluate the safety and tolerability of visilizumab in patients with severe ulcerative colitis that has failed to respond to steroid therapy.

What is visilizumab?

Visilizumab is an antibody designed to reduce inflammation. Antibodies are proteins that are normally made by the immune system to help defend the body from infections and other foreign substances. Visilizumab is thought to selectively affect the immune system to decrease inflammation and, in doing so, it may prevent damage to the intestine caused by ulcerative colitis.

Who can participate in this study?

The target population for this study is adults with severe ulcerative colitis that has resisted intravenous (IV) steroids. This study is open to patients with the following characteristics:

* 16-70 year olds
* A diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed within 36 months prior to study entry
* Active disease despite ongoing treatment with steroids

How is this study conducted?

Eligible participants will be administered visilizumab as one daily injection on two consecutive days. All medication and study-related care, except for the costs of in-patient hospitalization, are provided to qualified participants at no cost. This includes all visits, examinations and laboratory work.

How does one get more information?

This study is currently enrolling patients at hospitals and clinics in North America and Europe. For more information on the study or how to participate in it, please call 1-800-772-0482, email InfoCenter@pdl.com or visit www.IBDtrials.com.

PDL BioPharma, Inc. was formerly known as Protein Design Labs, Inc.

Eligibility Criteria:
Inclusion Criteria:

* 16 -70 year olds
* A diagnosis of ulcerative colitis verified by colonoscopy or barium enema performed within 36 months prior to study entry
* Active disease despite ongoing treatment with IV steroids
Activity Wristband-based Intermittent Teaching Unit and Students Physical Activity and Its Psychological Mediators

Objective: The main objective of the present study was to examine the effects of an intermittent teaching unit based on the use of activity wristbands and behavior modification strategies on high school students perceptions of autonomy support, satisfaction of basic psychological needs, motivation toward Physical Education and physical activity, intention to be physically active, and habitual physical activity levels.

Materials and methods: An initial sample of 353 high school students (final sample = 175; 45.7% females; mean age = 13.3 ± 1.2 years) from two public high schools were cluster-randomly assigned into the intermittent (n = 100) and control (n = 75) groups. The intermittent group performed an intermittent teaching unit twice a week for eight weeks. Specifically, the last 15 minutes of each lesson were used. As the main strategy to promote the practice of regular physical activity, students wore an activity wristband the whole day during the intervention period. Additionally, other behavior modification strategies were also applied (e.g., educational counseling, physical activity goals or reminders). The control group also performed two Physical Education sessions a week during the intervention period, but without using wristbands or other behavior modification strategies. Before and after the intervention, as well as at the end of the follow-up period (six weeks), students' physical activity practice mediators and physical activity levels were measured by validated questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Being enrolled in the seventh to tenth grade at the secondary education level
* Participating in the normal Physical Education lessons
* Being exempt of any health problem that would make them unable to engage in physical activity normally
* Presenting the corresponding signed written consent by their legal tutors
* Presenting their own corresponding signed written assent

Exclusion Criterion:

- Not having performed the evaluation of the dependent variables correctly at the pre-intervention, post-intervention and/or follow-up measures following the administration rules (being removed only for incomplete variables and not for the overall study)
AZD0530 Study 21 - Phase I Study in Patients With Solid Tumours

This is a dose escalation study to assess the safety and tolerability of AZD0530 in patients with advanced solid malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed advanced carcinoma / solid tumour of known primary site, which is refractory to standard therapies or for which no standard therapy exists
* World Health Organisation (WHO) performance status 0 to 2
* Life expectancy of at least 12 weeks

Exclusion Criteria:

* Inadequate bone marrow reserve
* Inadequate liver function, renal function or low hemoglobin
* Unresolved toxicity from anti-cancer therapy
CLOUD-R HAE REGISTRY

Angioedema is a disease characterized by the appearance of self-limiting edema that last 1-5 days and affect the subcutaneous tissue and/or gastrointestinal and oropharyngeal mucosa. In this last location edema can be lethal causing asphyxia, in all other cases full recovery is complete. Attacks can appear as part of the syndrome urticaria angioedema and can be of allergic origin. But there is a group of non-allergic angioedema that occur without hives and can be either hereditary or acquired. These angioedema are identified in some cases on the basis of etiology, in others are identified by the mediator and an overall classification of these forms of angioedema was published in 2014 as a result of a consent conference organized by the proponents of this registry. Being these forms of angioedema rare, there are not significative case studies inclusive of a high number of patients. This registry aims to collect in a single place a high number of subjects with recurring angioedema and without urticaria.

The Grenoble center is the registry coordinator at the national level. It will contract directly with the Cloud R Company and will be in charge of coordinating the associated centers. It will therefore send the necessary documents for the good execution of the study, will ask each center to respect the current French regulatory, will organize and finance the set-up of the register in the associated centers.

The coordinating center will also centralize requests for data, publications or creation of additional eCRF pages of associated centers. It will be able to organize a national scientific committee every 6 months. It will thus be the link between the French centers, the scientific committee of the registry and the company Cloud R.

The coordinating center will also be responsible for enter and reliability of patient data from it center, as well as the associated centers.

Role of associated centers Associated Centers will be responsible for capturing and data reliability of their patients in eCRF, they will also create a personal account for each patient so that it can download the application "cloud R HAE carnet de suivi".

Investigators referent patient will have validated at each visit or after contact with the patient crisis returned to the patient via it electronic diary.

Associated Centers will keep informed twice a year the coordinator center of the state of inclusions in the register.

Eligibility Criteria:
Inclusion Criteria:

* Any patient with isolated angioedema without associated wheals.
* Patients with hereditary angioedema with or without C1 deficiency.
* Major patient with consent (signature)
* Minor patient whose parents / legal guardians have given their consent (signature)

Exclusion Criteria:

* Patient unable to give consent.
* Wheals with angioedema
Early Oral Intake Following Cesarean Surgery

In this study we are trying to compare the safety and financial benefit of starting the realimentation early versus conventional oral intake following the Cesarean surgery in Iran.

Cesarean delivery is announced to constitute 50% of deliveries in the Capital and 39% of all the deliveries nationwide, which is far beyond the acceptable international normal range, according to the official site of the Ministry of Health and Medical Education of the Islamic Republic of Iran \[http://www.mohme.gov.ir/HNDC/Indicators/Simaye_Salamt/Simaye_Salamat.htm\]. This high rate of elective cesarean deliveries might be due to several reasons which are far beyond the scope of this study. Here we tried to see whether the reduction in the time of hospitalization for these patients is safe at the expense of earlier oral realimentation and to see whether this strategy increases the patients' satisfaction or not.

Eligibility Criteria:
Inclusion Criteria:

Women who had elective cesarean deliveries under regional anesthesia

Exclusion Criteria:

1. Receiving general anesthesia, magnesium sulfate or insulin.
2. Coming across an intraoperative bowel injury.
3. Having any medical or gastrointestinal problem that prohibits early feeding
Cardiac-CT in the Treatment of Acute Chest Pain

Objectives The CATCH trial (CArdiac cT in the treatment of acute CHest pain) is a prospective randomized controlled trial designed to evaluate the clinical value of cardiac multidetector computed tomography (MDCT) as a first-line diagnostic strategy in patients with acute chest pain, compared to a conventional functional-based testing strategy.

Methods:

Consecutive patients admitted with acute chest pain of suspected cardiac origin, but normal electrocardiogram and biomarkers were randomized to evaluation with 320-MDCT coronary angiography (CT-guided group) or with standard bicycle exercise test and/or myocardial perfusion imaging - MPI (Control group).

After one year, patients will be followed-up, with registration of clinical endpoints such as Cardiac death, myocardial infarction, need for revascularisation, admittance for heart related problems, sustained chest pain, live quality score, use of medication.


Eligibility Criteria:
Inclusion Criteria:

* Admittance because of Chest pain
* Non- or non-diagnostic ecg-changes.
* Normal biomarkers for ischemia (Troponins)
* Chest X-ray without pathological findings associated with chest pain.

Exclusion Criteria:

* Women of childbearing age, or \> 40 years and using approved contraception.
* Claustrophobia
* Patients with geographical residence, that complicates follow-up
* Patients with mental or physical conditions that impede follow-up
* Increase in Troponins
* New diagnostic ECG changes with ST-segment elevation or depression greater than 1mm or T-yew inversion\> 4 mm in\> 2 anatomically connected derivations.
* Allergy to iodinated contrast agents
* Serum creatinine greater than 130 mg/l
* Abnormal chest x-ray or blood tests hospitalization as assessed as the main cause of the patient's pain problem.
Study of the Pharmacokinetics of Golimumab in Moderate to Severe Ulcerative Colitis

The purpose of this study is to gain insights in the pharmacokinetics of golimumab in moderate to severe Ulcerative Colitis after subcutaneous administration, during induction and maintenance treatment the investigators will collect blood and stool samples at different time points.

The pharmacokinetic characteristics of golimumab will be assessed by using blood and stool samples; collected during induction and maintenance treatment Patients will undergo 13-16 blood sample collections, 13-16 stool sample collections and 3 endoscopies during 16 hospital visits in 1 year. They are also asked to fill in a short questionnaire (9x). At endoscopy visits a questionnaire regarding quality of life will be taken.The population pharmacokinetics of golimumab will be assessed using nonlinear mixed-effects modelling (NON-MEM).

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 years, either male or female
* Moderate to severe UC (according to Mayo score (2 or 3) baseline endoscopy), both anti-TNF naïve and anti-TNF exposed patients will be included
* Baseline endoscopy
* Obtained written informed consent

Exclusion Criteria:

* Contra-indication to golimumab: TBC, severe infections or congestive heart failure.
* Imminent need for surgery
Get in the GROOVE!

Get in the GROOVE! will address health disparities impacting underserved youth. Given the alarming rate of overweight and obesity among high school minority youth, the project will focus on middle school with the primary aim of reaching middle school girls before unhealthy habits become firmly ingrained.

The primary aim of the research project is to investigate the impact of two types of summer science enrichment programs (that focus on health and wellness) on middle school girls' self-efficacy, health knowledge, health behaviors, and interest in science. One program will present the curriculum by conventional means (GROOVE condition) while the second program will include the addition of a closed 3-D virtual world environment to reinforce concepts (GROOVE+ condition).

The following hypotheses will be tested in the randomized controlled trial:

1. Upon completion of the summer program, the enhanced summer program GROOVE+ relative to the conventional summer program will result in a) increased self-efficacy for adopting healthy behavior change; b) increased health knowledge; c) enhanced science self-concept; and e) more positive behavior change (e.g., improved nutrition, increased physical activity).
2. At follow-up, the enhanced summer program relative to the conventional summer program will result in further and/or sustained improvements in positive behavior health behaviors and attitudes.


Eligibility Criteria:
Inclusion Criteria:

* Girls 11-14 years old

Exclusion Criteria:

Girls are excluded if they are:

* not fluent in English
* enrolled in a special education program at school (other than gifted program) that would interfere with ability to master the material
* have a condition that would preclude their participation in the dance activities of the summer program
Topical Antifungal Treatment for Tinea Cruris

To determine if a topical antifungal cream is safe and effective for the treatment of tinea cruris


Eligibility Criteria:
Inclusion Criteria:

* moderate erythema, mild scaling, and moderate pruritis

Exclusion Criteria:

* pregnancy and allergies
Postural Management of Hyperkyphosis in Cardiac Rehab Patients

The goal of this clinical trial is to evaluate the efficacy of a home-based exercise program in managing hyperkyphosis, and its impact on physical performance and pulmonary function among cardiac rehabilitation patients.

The primary research question is: Can a home-based kyphosis-specific exercise program reduce thoracic hyperkyphosis and improve physical ability in cardiac patients undergoing cardiac rehabilitation? The study will consist of three groups: 1) Hyperkyphotic participants undergoing a 12-week exercise program at home, alongside a cardiac rehabilitation exercise program, 2) Hyperkyphotic participants solely undergoing cardiac rehabilitation exercise program, and 3) Participants without hyperkyphosis solely undergoing cardiac rehabilitation exercise program.

The groups will be evaluated based on measurements of kyphosis index, physical performance and spirometry at the beginning, after 6 weeks, and upon completion of the 12-week program.


Eligibility Criteria:
Inclusion Criteria:

* Heart patients who will be admitted for cardiac rehabilitation at Hadassah - Mount Scopus Hospital
* Normal stress test results.
* Independent mobility.
* Stable hemodynamic and respiratory status.
* Ability to speak and read basic Hebrewץ
* Ability to watch videos on a mobile phone or computer.
* Not receiving any other forms of physical therapy or physical treatment.

Exclusion Criteria:

* Presence of unstable angina.
* Neurological disorders or mental illnesses that interfere with communication.
* Movement disorders due to neurological disease.
* Severe orthopedic limitations hindering the execution of motor exercises.
12 Week Study of the Safety/Efficacy of Asenapine When Added to Lithium/Valproate in the Treatment of Bipolar Disorder (A7501008 / P05844 / MK-8274-017)

This is a 12-week study that will test the safety and efficacy of asenapine when used in addition to lithium or valproate for subjects with acute manic or mixed episodes of Bipolar I Disorder.


Eligibility Criteria:
Inclusion Criteria:

* Have bipolar I disorder, current episode manic or mixed
* Treated with lithium or valproic acid

Exclusion Criteria:

* Have an unstable medical condition
* Clinically significant laboratory abnormality.
* Have a primary diagnosis other than bipolar I disorder.