cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Effectiveness of Methylphenidate in Swedish Male Prison Inmates With Attention-deficit Hyperactivity Disorder (ADHD)

The purpose of this study is to evaluate the efficacy and effectiveness of methylphenidate in treatment of ADHD in Swedish adult male prison inmates diagnosed with ADHD.

The purpose of this study is to evaluate the efficacy of Prolonged Release (PR) OROS methylphenidate in fixed dosage as compared to placebo, and the effectiveness of flexible dosage Prolonged Release (PR) OROS methylphenidate in Swedish adult male prison inmates with attention-deficit hyperactivity disorder (ADHD). An initial randomised, double-blind, placebo-controlled parallel group trial for 5 weeks is followed by an open-label extension for maximum 47 weeks, comprising altogether 52 weeks of treatment. A follow-up is carried out 12 and 36 months post-study, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Male, 18-65 years, imprisoned at Norrtalje Prison
* WURS-score of 36 or more and fulfilling at least 4 out of 6 criteria on ASRS Screener in an initial screening preceding the trial
* Can read and understand Swedish well enough to participate in the evaluation preceding the trial
* Diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition, (DSM-IV) and confirmed by the neuropsychiatric assessment including structured diagnostic interviews and neuropsychological measurements.
* At least 14 months left to conditional release.
* Informed Consent Form to participate in the study signed by the subject.
* Subject agrees to take only the supplied study drug as treatment for ADHD during the study
* Subject is able to comply with the study visit schedule and willing and able to complete the protocol-specified assessments.
* Healthy on the basis of a physical examination and the results of blood biochemistry tests. If the results of the biochemistry tests are not within the normal reference ranges, the subject may be included if the investigator considers the deviations are not clinically relevant.

Exclusion Criteria:

* Known to be a non-responder to methylphenidate.
* Known allergy or hypersensitivity to methylphenidate.
* Any clinically unstable psychiatric condition including, but not limited to, acute mood disorder, bipolar disorder, acute OCD.
* A diagnosis of substance use disorder (abuse/dependence) according to DSM-IV criteria within 3 months prior to screening evaluation for the study.
* Known mental retardation.
* Subjects with history of epileptic seizures, glaucoma, uncontrolled hypertension, angina pectoris, cardiac arrhythmias or structural heart abnormalities.
* Use of monoamine oxidase inhibitors, fluoxetine, venlafaxine, reboxetine, duloxetine.
* Use of alpha-2-receptor agonists, neuroleptics, theophylline, coumarin anticoagulants or anticonvulsants.
* Liver or renal insufficiency. Subjects with hepatitis C without liver insufficiency don´t have to be excluded as long as liver enzymes are followed through the study.
* Subjects who are suicidal.
* Lactose intolerance.
A Japanese Phase 1 Trial of c-Met Inhibitor MSC2156119J in Subjects With Solid Tumors

This is a Japanese multicenter, open-label, Phase 1 study to evaluate safety and efficacy of MSC2156119J in subjects with malignant solid tumor which is refractory to standard therapy or to which no effective standard therapy is applicable.


Eligibility Criteria:
Inclusion Criteria:

* A subject with a histologically or cytologically confirmed diagnosis of malignant solid tumor which is refractory to standard therapy or to which no effective standard therapy is applicable
* An archived tumor tissue is available or biopsy of tumor tissues can be newly performed
* A Japanese male or female, age greater than or equal to (\>=) 20 years
* A subject who has read the Subject Information Sheet and understood the details of this clinical trial, and is willing and able to give his/her informed consent.
* A female of child-bearing potential must have a negative blood pregnancy test result at her screening period. A female subject of child-bearing potential must be willing to avoid pregnancy by using an adequate method of contraception Life expectancy is at least 3 months
* Other inclusion criteria apply

Exclusion Criteria:

* Known Human immunodeficiency virus (HIV) positivity, active hepatitis C, or active hepatitis B
* Presence of liver fibrosis or liver cirrhosis that has been histologically diagnosed
* Signs or symptoms that suggest transmissible spongiform encephalopathy
* Received major surgery within 6 weeks before Day 1 in Cycle 1
* Known drug abuse or alcohol abuse
* Known hypersensitivity to any of the trial treatment ingredients
* Hematological test abnormalities
* Renal impairment as defined in the protocol
* Liver dysfunction as defined in the protocol
* History or presence of central nervous system metastasis
* History or presence of disease or condition that may hamper compliance or absorption of the investigational medicinal product (IMP) due to difficulty in swallowing or absorption
* Poor performance status of Eastern Cooperative Oncology Group Performance status (ECOG PS) \>= 2
* Received any anti-cancer therapy days Received extensive prior radiotherapy that irradiates more than 30 percent of bone marrow
* Received any radiotherapy within 4 weeks before Day 1 in Cycle 1
* Pregnancy and lactation period
* History of receiving treatment with any c-Met signaling pathway inhibitor
* Participation in another interventional clinical trial within the past 30 days from Day 1 in Cycle 1
* Other significant disease that in the Investigator's opinion would exclude the subject from the trial
* Legal incapacity or limited legal capacity
* Other exclusion criteria apply
Bicarbonate Administration and Cognitive Function in Midlife and Older Adults With CKD

This is a pilot, randomized, double-blinded, placebo-controlled, 12-month trial of 50 patients with CKD stage 3b-4 with metabolic acidosis to examine the effect of sodium bicarbonate therapy on cognitive and cerebrovascular function.


Eligibility Criteria:
Inclusion Criteria:

* Age 50-75 years old
* Serum bicarbonate 16-22 mEq/L on 2 separate measurements (at least 1 day apart)
* CKD stage 3b or 4 at time of screening (eGFR 15-44 ml/min/1.73m2)
* Blood pressure \<130/80 mm Hg prior to randomization
* Use of angiotensin converting enzyme inhibitor or angiotensin receptor blocker
* Stable anti-hypertensive regimen for at least one month prior to randomization
* Montreal Cognitive Assessment Score \> 24
* No history of stroke
* No history of dementia
* No history of neurologic disease
* Able to provide consent

Exclusion Criteria:• Significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year

* Use of chronic daily oral alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)
* Uncontrolled hypertension
* Serum potassium \< 3.3 or ≥ 5.5 mEq/L at screening
* New York Heart Association Class 3 or 4 heart failure symptoms, known EF ≤30%, or hospital admission for heart failure within the past 3 months
* Factors judged to limit adherence to interventions
* Anticipated initiation of dialysis or kidney transplantation within 12 months
* Current participation in another research study
* Pregnancy or planning to become pregnant or currently breastfeeding
* Chronic use of supplemental oxygen
Cognitive Support Program for Patients With Brain Metastases

This study evaluates the feasibility and preliminary efficacy of a brief cognitive-behavioural program designed to improve cognitive functioning in people with brain metastases.

Cognitive impairments (such as problems with attention, executive functions, memory and language abilities) are common in people with brain metastases as a result of disease and/or treatment effects. These impairments can significantly limit functional independence, participation in valued roles and activities, and overall quality of life.

Building on research in other cognitively-impaired populations, we designed a brief, structured, patient-centered Cognitive Support Program (CSP) for brain metastases patients, who have the option of participating with a caregiver. Program contents include supportive psychoeducation, mindfulness practice, and strategy training (e.g., strategies to improve memory or concentration). This prospective, single-arm study will enroll 24 brain metastases patients to evaluate the feasibility and preliminary efficacy of the CSP. A battery of outcome measures is administered (1) prior to intervention, (2) after completing the CSP, and (3) after an additional 3 months to evaluate longer-term outcomes. Feasibility assessment will include program retention and adherence. Reliable change analyses will examine treatment effects, with regression analyses to explore moderating effects of select patient, disease and treatment factors (e.g., severity of baseline cognitive impairment, number of brain lesions, cranial radiation dose and distribution). Results of this trial will inform further development and implementation of evidence-based supportive care for cognitively-impaired brain metastases patients.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* able to provide informed consent to all procedures
* diagnosis of one or more brain metastases, with primary cancer outside the CNS
* indication of cognitive deficits from self-report and/or cognitive testing
* interest in participating in a cognitive rehabilitation program
* able to complete study activities

Exclusion Criteria:

* concurrent non-cancer-related neurological or major psychiatric disorder or other medical condition suspected to influence cognition
Validation of the STarT Back Screening Tool in the Military

This is a trial to validate the use of the STarT Back Screening Tool (SBST) in the Military Health System for patients with low back pain presenting to primary care.

Subjects with low back pain presenting to primary care will be enrolled in a study that aims to evaluate the utility of the SBST for providing risk-stratified care. The concept of this approach revolves around matching treatment to patients based on their risk for developing chronic disability from back pain. Those at low risk receive less treatment, and those at high risk need more specialized treatment, that includes psychosocially-focused and cognitive considerations. This approach will be compared to usual care, where general practitioners carry out the course of action they think best for each patient, without any other guidance. Patients will be followed for 1 year.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females who are between the ages of 18-50 years old
2. Primary complaint of LBP for any duration, with or without associated radiculopathy
3. Can speak and understand English
4. Be willing and able to give full, informed written consent

Exclusion Criteria:

1. Red Flags: Any potentially serious or systemic disorders (e.g., cauda equina compression, inflammatory arthritis, compression fracture, malignancy, infection, severe neurological progression), serious illness or comorbidity
2. Spinal surgery in the past 24 months
3. Current pregnancy (or within the last 6 months)
4. Already receiving treatment (other than primary care) for this episode of LBP
5. Inability to attend regular treatment sessions
6. Pending litigation or a medical evaluation board
Effectiveness of a Natural Ingredient on Appetite Regulation

Single-center, double-blind, double-crossed, randomized controlled clinical trial with two crossed branches, designed with the objective of evaluating the effect of the investigational product on satiety.

Subjects who meet the selection criteria will make a total of five visits to the research laboratory and will carry out the tests established in the protocol. Subsequently, a statistical analysis will be performed with the variables measured in the study to obtain results.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years.
* Both genders.
* BMI 25-34.9 kg / m2, both inclusive.
* Weight maintained during the last 3 months.
* Smoking subjects or not, but in any case they do not change their nicotinic habits during their participation in the study.
* Absence of disease diagnosed at the start of the study.

Exclusion Criteria:

* Thyroid dysfunction, infections, or with any type of chronic disease (eg, autoimmune, inflammatory).
* History of allergic hypersensitivity or poor tolerance to any component of the products under study.
* Subjects who are performing or intend to carry out any type of diet, low-calorie or not, during the study.
* Participation in another clinical trial in the three months prior to the study.
* Lack of will or inability to comply with clinical trial procedures.
* Pregnant woman.
* Subjects whose condition does not make them eligible for the study according to the researcher's criteria.
French Observational Study With Colic Capsule

colic capsule usings with patients without possible colic endoscopy


Eligibility Criteria:
Inclusion Criteria:

* anesthesia not possible
* incomplete colic endoscopy
* colic endoscopy refused

Exclusion Criteria:

* none
Effects of Massage on the Immune System of Preterm Infants

Infants in the Neonatal Intensive Care Unit (NICU) are exposed to stressful stimuli such as loud noises, bright lights, blood drawing, suctioning, and intubation, and are frequently left in isolation with minimal proper interaction. Stress has been demonstrated to exert a negative effect on the immune system. Different psychological interventions, including relaxation, have been used in efforts to reduce stress, and several of these techniques have been shown to improve cellular immunity. Massage therapy (MT) has been used to reduce stress in premature infants and has been associated with weight gain, shorter hospital stay, and improvement in mental/motor development. While MT has been shown to increase the number and function of natural killer (NK) cells in healthy adults and in adults infected with HIV, the effect of MT on the immune system of children, including premature infants, has never been investigated. The investigators hypothesize that, in premature infants, MT will enhance the immune system. One hundred and twenty stable premature infants meeting selection criteria will be randomized to massage and sham treatment groups. Immunologic evaluation will be performed on both groups at baseline, midway and at the end of therapy. Physicians, nurses, and parents will be masked. The investigators' unique and innovative study will be the largest study in this area and will provide valuable information on potential immune parameters associated with stress reduction and improved development in premature infants undergoing massage therapy.

Already contained in Brief Summary

Eligibility Criteria:
Inclusion Criteria:

* Medically stable premature infants

Exclusion Criteria:

* Unstable premature infants with underlying medical condition
Bioavailability Study of Levetiracetam Tablets, 750 mg of Dr. Reddy's Under Fasting Conditions.

The purpose of this study is to compare the single-dose relative bioavailability study of Levetiracetam Tablets 750 mg with Keppra® 750 mg Tablets under Fasting conditions.

This is an open-label, randomized, single-dose 2-way crossover relative bioavailability study in healthy adult male volunteers under fasting conditions with a washout period of 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult male volunteers, 18 to 55 years of age;
* Weighing at least 60 kg and within 15% of their ideal weights (Table of "Desirable Wights of Adults", Metropolitan Life Insurance Company, 1983);
* Medically healthy subjects with clinically normal laboratory profiles and ECGs as deemed by the principal investigator;
* Voluntarily consent to participate in the study

Exclusion Criteria:

* History or presence of significant cardiovascular, pulmonary, hepatic, renal hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
* In addition, history or presence of:

  1. alcoholism or drug abuse within the past 2 years;
  2. hypersensitivity or idiosyncratic reaction to levetiracetam;
* Subjects who have been on an special diet (for whatever reason) during the 30 days prior to the first dose and throughout the study.
* Subjects who have made a donation (Standard donation amount or more) of blood or blood products (with the exception of plasma as noted below) within 56 days prior to the first dose.
* Subjects who have made a plasma donation within 7 days prior to the first dose.
* Subjects who have participated in another clinical trial within 30 days prior to the first dose.
* Subjects with hemoglobin less than 12.0 g/dL.
* Subjects who have participated in another clinical trial within 30 days prior to the first dose.
Follow-up Study of Complications of Acute Pancreatitis

This is a follow-up study focusing on long-term complications of acute pancreatitis. The primary purposes include: 1. To assess the incidence of type 2 diabetes mellitus（2-DM）,impaired glucose tolerance, metabolic abnormalities of blood lipids after acute pancreatitis. 2. To observe the possible long-term clinical outcomes after acute pancreatitis attack, which may include: chronic pancreatitis, pancreatic cancer, pancreatogenic portal hypertension, autoimmune pancreatitis et al. 3. To evaluate the long-term influence of acute lung injury(PaO2/FiO2\<200,FiO2 means fraction of inspiration O2) in AP patients during ICU stay on life qualities of the patients; 4. To observe the prognosis of the local complications of acute pancreatitis(AP) patients; it might be helpful to find the most effective and targeted interventions aiming at different phases after AP attack.

Currently，follow-up study is limited on glucose intolerance and life quality assessment. However, it has been shown that AP is associated to some extent with other diseases such as chronic pancreatitis, pancreatic cancer, pancreatogenic portal hypertension and autoimmune pancreatitis; In addition, for patients who have severe lung injury following AP, especially with PaO2/FiO2\<200 during ICU stay, the long term prognosis remains unclear. Thus, a large sample follow-up study is essential for elucidating the possible long-term complications.

Prior to follow up study, the investigators performed baseline analysis of AP patient data from the database of the First Affiliated Hospital of Nanchang University. It is estimated that 1300 patients will be interviewed over telephone and 600 patients in the outpatient department. The content of the follow-up includes: questionnaire (the MOS\[medical outcome study\] item short from health survey, SF\[short form\]-36) ; lab testing(complete blood count, blood chemistry such as liver and kidney function, C-reaction protein(CRP), AMY, fasting blood-glucose，1 and 2 hour postprandial blood glucose,C-peptide, blood lipids, FE-1) and CT scan. For patients who have severe lung injuries during ICU stay, pulmonary function test, Blood gas analysis and chest CT will be performed. After screening, the patients with chronic pancreatitis(CP), pancreatic cancer(PC), post Pancreatogenic portal hypertension（PPH） or autoimmune pancreatitis(AIP）will be hospitalized for further therapy.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute pancreatitis from our hospital
* Must be signed the informed consent

Exclusion Criteria:

* Failed to complete the questionnaire survey and the follow-up examination
Efficacy and Safety of Enteric-Coated Mycophenolate Sodium (EC-MPS) in Kidney Transplant Recipients

This study will investigate the safety, tolerability and efficacy of EC-MPS with tacrolimus at both reference and reduced levels. This study will take into account safety aspects such as decreased renal toxicity by reducing the overall exposure to tacrolimus.


Eligibility Criteria:
Inclusion Criteria:

* Male or female kidney transplantation patients, 18 to 70 years of age, receiving a primary cadaveric, living unrelated, or non-HLA identical living related donor kidney.
* The renal cold ischemic time (CIT) must be \<30 hours
* The age of the donor must be between 10 and 65 years

Exclusion Criteria

* Patients who have previously received an organ transplant
* Patients who are recipients of a multiple organ transplants
* Recipients of non heart-beating donor organs
* ABO incompatibility against the donor

Other protocol-defined exclusion criteria may apply.
Exercise and Behavioral Therapy in Obese Children

The aim of this study is to compare the effects of exercise training and family-based behavioral treatment, either in individual or in group setting, in pre-pubertal children and their mother.

Introduction: The prevalence of childhood obesity is increasing rapidly in developing countries. The aim of this study is to determine the effects of exercise training and family-based behavioral treatment (FBBT), either in individual or in group setting,in pre-pubertal children and their mother.

Methods: This is a 6-month randomized controlled trial (RCT) including 75 pre-pubertal obese children (age 8-11 years) randomly assigned to an Intervention (I, n=50) or a Control group (C, n=25). The intervention consists of a family-based behavioural therapy in group (1 session/week with a dietician and a psychologist) or in individual setting (paediatrician or dietician 1x/month). The intervention includes exercise training sessions twice a week (60 minutes each).

Measures include: body mass index (BMI), waist and hip circumferences; whole body and abdominal fat mass by DXA; resting and ambulatory blood pressure; arterial intima-media thickness and vascular reactivity (flow-mediated dilation)using high resolution ultrasound; arterial stiffness by tonometry of applanation; cardiorespiratory fitness by a treadmill test; physical activity; fasting lipids, glucose, insulin, and C-reactive protein levels; health-related quality of life and psychological health using standardized questionnaires and a semi-structured interview. Measures are completed in children and their mother at baseline and 6 months post-randomization.

Eligibility Criteria:
Inclusion Criteria:

* Childhood obesity (\>97 percentile WHO references)

Exclusion Criteria:

* being involved in any weight control, physical activity, behavior therapy, or gastric surgery program;
* familial history of dyslipidemia or essential hypertension;
* medications or hormones, which may influence cardiovascular function, body composition, lipid or glucose metabolism in the preceding 6 months;
* orthopaedic affection limiting physical activity;
* genetic disorder or another chronic disease;