cyrilzakka/clinical-trials huggingface dataset:
Effect of Prebiotic Fructans to Reduce Number of Febrile Infections in Children

The study aims to confirm the effectiveness of chicory-derived prebiotic inulin-type fructans on the reduction of the number of febrile infections diagnosed by the paediatrician in children.


Eligibility Criteria:
Inclusion Criteria:

* Subject is healthy at the time of pre-examination
* Subject is aged 3-6 years at the time of pre-examination
* Subject attends a kindergarten at the time of pre-examination

Exclusion Criteria:

* Suffering from current infection or has suffered from infection in previous 7 days
* Intake of antibiotics and/or laxatives in the previous 14 days prior to start of the intervention
* children with known gastrointestinal disease or malformation
* children with congenital or acquired immunodeficiency
* children with food intolerance, food allergy
* children that regularly consume (more than 3 times per week) probiotic products or a food supplement containing prebiotics
* children involved in any clinical or food study within the preceding 6 months
131I-rituximab for Relapsed or Refractory Marginal Zone B-cell Lymphoma

Marginal zone B-cell lymphoma (MZL) is a lymphoma originated from B-cell in lymph node with variable differentiation status, which is distributed to a variety of organs.

A high response rate and long term survival is possible through surgery or radiation therapy alone in the case of limited disease. However frequent relapse and progression is observed despite of long term survival. The treatment after relapse has not been established yet.

So we investigate the efficacy of radioimmunotherapy using 131I-rituximab in refractory or relapsed patients with MZL.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed marginal zone B-cell lymphoma
* relapsed or refractory patients after treatment including chemotherapy, radiation therapy, and surgery
* Eastern Cooperative Oncology Group performance status ≤ 2
* age≥ 20 years
* More than one measurable lesion (More than 2cm sized lesion in conventional CT scan, More than 1cm sized lesion in spiral CT or contrast-enhanced PET/CT )
* Adequate renal function (serum creatinine ≤ 2.0 mg/dl or Ccr ≥ 60 ml/min)
* Adequate hepatic function (serum bilirubin ≤ 2.0 mg/dl , AST/ALT ≤ 3 upper normal limit)
* Adequate bone marrow reservoir (ANC ≥1,500/㎕, platelet count≥ 75,000/㎕)
* patient who agree the purpose and intention of this clinical trial

Exclusion Criteria:

* recent (\<5 years) history of other malignancy or unrecovered from the disease (appropriately treated skin cancer and uterine cervix carcinoma in situ are excluded)
* hemodynamically unstable due to the recent (\<12 months) history of severe heart disease such as myocardial infarction
* acute complications of severe lung or metabolic disease
* Combined severe neurological or psychiatric disease
* Unrecovered from infection or other medical disease
* Recent (\<30 days) history of enrollment of other clinical trial
* Pregnant or breast-feeding woman
* women of childbearing potential and men not employing adequate contraception at least for 1 year
* Previous history drug allergy to the content of 131I-rituximab
* Infection(sepsis, pneumonia, viral infection, etc) (inactivated hepatitis B carrier can be enrolled)
Gastrointestinal Motility in Severe Ulcerative Colitis Obtained by Motilis-3D-transit

The purpose of this study is to describe gastrointestinal (GI) motility in patients suffering from severe Ulcerative Colitis (UC) and to compare these results with similar results obtained in remission.

The study is done with the use of Motilis 3D-Transit system which consists of a small electronic capsule ingested and detected by a receiver carried by the patient. Position and orientation of the capsule are interpreted by dedicated computer software and transit times, progression velocity and contraction frequencies can be revealed.

The study is mainly descriptive and is designed to test and evaluate the usefulness of the Motilis 3D Transit system in UC patients and to tell investigators more about GI motility during and after severe inflammation.

Motilis 3D-Transit system gives investigators a unique chance to study the gastrointestinal canal as a whole during and after severe illness.

The investigators expect to include 20 patients suffering from severe UC admitted to Hospital with the purpose of getting medical treatment. The investigators do not expect any drop out, but in case of drop out a new patient will be included.


Eligibility Criteria:
Inclusion criteria:

* Severe Ulcerative colitis (modified Truelove and Witt score)
* Signed informed consent obtained
* Fasted since midnight

Exclusion Criteria:

* Known GI related symptoms complaints or GI diseases
* Swallowing disorders
* Cancer or other life threatening diseases or conditions
* Pregnancy or breast-feeding
* Previous abdominal surgery
* Abdominal diameter \>140cm?
* Drug abuse or alcoholism
* Irregular bowel movements
* Known cardiovascular or pulmonary diseases
* Participation in any clinical study within the last 30 days
* Cardiac pacemaker or infusion pump or any other implanted or portable electro-mechanical medical device.
* Medication affecting GI motility
* MRI within the next four weeks
Impact of 60 Days Powdered Tart Cherry Supplementation on Metabolic Syndrome

Metabolic syndrome (MetSyn) is a growing health concern, with up to 25% of the worlds population having the syndrome. MetSyn is a primary risk factor for cardiovascular disease and type II diabetes development, and is independently associated with all-cause mortality, making it an important disease target. The primary treatment for MetSyn is exercise and weight loss, along with medically necessary treatment. Exercise, along with dietary changes such as increased fiber and polyphenol intake can positively impact many of the metabolic abnormalities seen with MetSyn. For example, polyphenols have been shown to decrease lipid concentration and improved glucose clearance as well as decreased oxidative stress and inflammation. Powdered tart cherry capsules, which contain the skin of the fruit, provides polysaccharides (fiber) that would likely act as a substrate for gut bacteria degradation, providing energy substrates and barrier integrity to the colonocytes and increasing the bioavailability of the polyphenols to other cells in the body. However there have been no long-term investigations into the use of powdered tart cherry supplements in MetSyn, therefore we aim to determine if 60 days tart cherry supplementation modify criteria for MetSyn in currently diagnosed individuals including body mass, waist circumference, blood pressure, blood lipid levels and blood glucose control.


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with metabolic syndrome by a physician or meet the diagnostic criteria: Waist circumference greater than 40 inches (men) or greater than 35 inches (women), High blood pressure (greater than 130/80) or taking medication for high blood pressure, High triglycerides (greater than 150 mg/dL) or low HDL (less than 40 for men, less than 50 for women), High fasting blood glucose (100-126 mg/dL) or diagnosed as pre-diabetic
* Age 25-60

Exclusion Criteria:

* currently taking medication for glucose or lipid control, such as metformin and/or statin
* currently using anti-inflammatory medications \& have not used corticosteroids in the last two months
* diagnosed with or currently being treated for an inflammatory condition
* major organ system impairment (heart failure, renal failure, severe impairment of respiratory function)
* currently a smoker or quit less than 12 months ago
Study to Evaluate the Safety and Efficacy of CNTX-4975 in Subjects With Chronic, Moderate to Severe Osteoarthritis Knee Pain

The purpose of this study is to evaluate the safety and efficacy of a single injection of CNTX-4975 in subjects with chronic, moderate to severe osteoarthritis knee pain.


Eligibility Criteria:
Inclusion Criteria:

* Radiography of both knees with a posterior-anterior, fixed flexion view taken during the Screening period. The index knee must show evidence of chronic OA.
* Moderate to severe pain in the index knee associated with OA must be stable for a minimum of 2 months prior to Screening, as assessed by the Investigator.
* A specified mean pain score in the index knee over the 7 days prior to dosing, based on question A1 of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC A1).
* Specified baseline and screening scores on the WOMAC A1
* Body Mass Index ≤ 45 kg/m2.
* Subjects must have had a therapeutic failure (no relief, or inadequate relief), and/or AEs resulting in stopping treatment, and/or contraindication to the standard of care appropriate to the severity of the index knee OA pain they are experiencing.

Exclusion Criteria:

* Joint replacement surgery of the index knee at any time, or open surgery of the index knee in the past 12 months.
* Prior arthroscopic surgery of the index knee within 3 months of Screening.
* Any painful conditions of the index knee due to joint disease other than OA.
* Mild pain in the non-index knee when walking.
* Other chronic pain anywhere in the body that requires the use of analgesic medications.
* Secondary OA of the index knee due to acute traumatic injury.
* Significant current or past instability (e.g., cruciate ligament tear or rupture or previous repair) or misalignment (\> 10 degrees varus or valgus) of the index knee
* Has used topical capsaicin on the index knee within 90 days of Screening.
* Corticosteroid injection in the index knee within 90 days of Screening.
* Received IA viscosupplementation (e.g., Synvisc®, Hyalgan®) within 90 days of Screening.
* Prior participation in an ALGRX 4975 or CNTX-4975 study.
* Has any of the following characteristics:

  1. active or historic substance use disorder within the previous year as defined by the Diagnostic and Statistical Manual for Mental Health Disorders, fifth edition, or
  2. tests positive upon urine drug screen for a substance of abuse.
* Has moderate to severe depression or anxiety.
ISTAPS: A Stepped Primary Care Smoking Cessation Intervention

Primary care centers can play a very important role in helping people to stop smoking. There is a large body of research on the effectiveness of specific interventions especially addressed to people who want to stop smoking. In addition to that, there are no studies with a large sample of individuals included that tested the complete range of interventions recommended nowadays for helping people in the different smoking cessation stages of change and with different degrees of physical and psychological dependence, especially including motivational interviewing in those not interested in cessation in the very next weeks. This study will test a complex intervention that at first classifies smokers in stages and after that treats every smoker according to what stage he/she is in at the moment, his/her degree of dependence and his/her own characteristics.

OBJECTIVES:

* To evaluate the effectiveness of a stepped smoking cessation intervention based on a transtheoretical model of change that uses the pharmacological and no-pharmacological methods proposed by evidence based Clinical Practice Guidelines for smoking cessation from primary care centers.
* To assess the health status change in relationship with the smoking cessation process.

DESIGN: Cluster randomized clinical trial

Unit of Randomization: Care basic unit (family physician or nurse that cares for the same group of patients). Intention to treat analysis.

PARTICIPANTS: 2911 smokers (ages 14-75 years) consulting for any reason to primary care centers

INTERVENTION: 6-month implementation of recommendations of a Clinical Practice Guideline that includes motivational consulting for smokers at the precontemplation - contemplation stage; brief intervention for smokers in preparation-action who do not want help; intensive intervention with pharmacotherapies for smokers in preparation-action who want help; and reinforcing intervention in the maintenance stage.

CONTROL: Usual care

MEASUREMENT: Self reported abstinence confirmed by an expired air carbon monoxide concentration of 10 parts per millions or less; Point prevalence at the end of intervention, 1 and 2 years after the beginning of intervention; Continuous abstinence rate for 1 year; Change of stage in the smoking cessation process; Health status measured by SF-36.

Eligibility Criteria:
Inclusion Criteria:

* Smokers
* Accept participation and follow-up by phone interviews for 2 years

Exclusion Criteria:

* Terminal illness
* Active addictive behaviours or important health problems
Chemotherapy With or Without Enoxaparin in Pancreatic Cancer

To evaluate the safety and efficacy of chemotherapy with or without enoxaparin. This study is powered to decrease the DVT/ VTE events rate from 10% to 3% with enoxaparin in the experimental arm.

N=540pts, dropout-rate 15%, power 80 %, two sided, significant level 5%

Approximately 20% of patients (pts) diagnosed with pancreatic adenocarcinoma (PA) develop venous thromboembolism, which may contribute to the dismal prognosis of PA. A small phase II trial suggested an improved survival by the addition of low molecular weight heparin (LMWH) to chemotherapy. We conducted a small pilot study which indicated that the addition of enoxaparin to chemotherapy GFFC chemotherapy is safe and feasible in pts with advanced PA. Furthermore, results of several phase III studies suggest that pts in good performance status may benefit from more intensive chemotherapy regimen (Riess et al; Heinemann et al; ASCO 2005). Based on these considerations we started the multicenter phase III study CONKO 004.

540 patients are to be recruited into this study. Primary stratification takes place according to Karnofsky performance status and kidney function. Patients with KPS \> 80% and normal kidney function receive GFFC +/- LMWH (gemcitabine 1 g/m2 (30 min), cisplatin 30 mg/m2 (90 min), 5-fluorouracil 750 mg/m2 (24 h), folinic acid 200 mg/m2 (30 min), d1, 8; q3w +/- Enoxaparin 1mg/kg daily s.c.). Pts with KPS \< 80 % and increased creatinin plasma levels (\>1.3 mg/dl) receive the current standard therapy (gemcitabine 1 g/m2 (30 min), d1, 8, 15; q4w) +/- LMWM +/- Enoxaparin 1mg/kg daily s.c. After 12 weeks of initial chemotherapy all patients who have not progressed received the standard therapy (gemcitabine mono) +/- Enoxaparin 40mg/d s.c.

Eligibility Criteria:
Inclusion Criteria:

* histological or cytological pancreatic carcinoma, stage IV A, b
* no preceding radio or chemotherapy of the primarius or the reference lesions
* Karnofsky performance status ≥ 60%
* measurable tumor lesion by spiral CT or MRT not older than 14 days
* no deep venous thrombosis within the last 2 years
* patient compliance and geographical proximity of the residence, which make an adequate follow up possible
* sufficient bone marrow reserve: leukocyte ≥ 3.5 × 109 /l, thrombocyte ≥ 100 × 109 /l
* signed informed consent
* minimum age of 18 years
* women/men must provide sufficient pregnancy prevention

Exclusion Criteria:

* preexisting indication for anti-coagulation of other reason
* bleeding in the last 2 weeks or increased bleeding risk (e.g. serious coagulating disturbance, active stomach or intestine ulzera, or had operational interferences in the last 2 weeks)
* body weight \< 45 kg and/or \> 100 kg
* pregnancy or insufficient preventing methods in the study process
* serious illness, which are incompatible with a study participation
* hypersensitivity to study drugs
* patients with serious kidney malfunction (Creatininclearance \< 30 ml/min)
Impact of Restriction of the Non Paretic Upper Limb Rehabilitation of Patients a With Stroke:Randomized Clinical Trial

To evaluate whether the restriction of the non paretic upper limb (UL) is a factor that could interfere at the sensorimotor UL recovery for chronic stroke subjects and to verify the impact on daily function, quality of life. In this pilot, randomized, blind and allocation concealment clinical trial, nineteen individuals with chronic stroke was randomly assigned, after the first evaluation, into two groups: group without restriction (G1), subject only to the specific training of paretic UL, and restricted group (G2), which underwent specific training of paretic UL and use of the restriction of non paretic UL


Eligibility Criteria:
Inclusion Criteria:

* ability to actively extend at least 10° at the metacarpophalangeal the wrist;
* more than 6 months post onset of stroke;

Exclusion Criteria:

* Mini-Mental State Examination;
* no excessive spasticity in any joints of the affected.
Comparison of Different Methods of Controlling Pain During Debonding of Orthodontic Brackets

Purpose of this study was to evaluate different methods of controlling pain during debonding

Patients data was obtained from the Department of Orthodontics, Armed Forces Institute of Dentistry, Rawalpindi. One Hundred and ten patients were included in the study, which were divided into two groups, 55 patients in each group, based on method of controlling pain during debonding. To control pain during debonding in one group , teeth were stabilized with finger pressure with cotton between finger and teeth and then debonding using open mouth technique was done. In second group teeth were stabilized using a plastic wafer between maxillary and mandibular teeth and then debonding was done using closed mouth technique. In order to reduce biasness, all of the patients were debonded with same plier and with wires still ligated to brackets. With the help of VAS, pain score was measured after debonding. A single operator performed complete procedure of debonding and pain recording.

Eligibility Criteria:
Inclusion Criteria:

Patients between 13-21 years of age who can understand, assess, and answer the questionnaires. 2) No missing teeth except extracted premolars 3) Undergoing upper and lower fixed orthodontic treatment with Roth prescription 0.022-inch metal brackets . 4) Finishing arch wires present for at least two months

Exclusion Criteria:

1. The subjects with a previous history of facial or mandibular surgery or syndromes affecting the jaw or face .
2. Patient with history of jaw sugeries.
3. Patients with history of taking medicine periodically or in the last 24 hours (eg, painkillers, corticosteroids, and antiflu drugs),
4. Patient with history of debonded brackets and replacement.
5. Patient with history of tooth transplantation or microscrews placement.
A Prospective Trial of Ultrasound Versus Landmark Guided Central Venous Access in the Pediatric Population

The investigators hypothesized that, in children undergoing venous cannulation for central line placement by pediatric surgeons, ultrasound-guided cannulation leads to an increase in successful venous cannulation at first attempt compared to landmark guided cannulation.


Eligibility Criteria:
Inclusion Criteria:

* All patients between the ages of 0 and 18 years undergoing tunneled central venous line placement under general anesthesia

Exclusion Criteria:

* Preoperative proof of non-patency of central veins
* coagulopathy
* access site surgeon
Drug Interaction & Methadone & Buprenorphine

The purpose of this study is to assess the effects of steady state DCV/ASV/BMS-791325 fixed dose combination (FDC) + 75mg BMS-791325 on the Pharmacokinetics (PK) of Methadone in subjects with the stable dose of Methadone and on the PK of Buprenorphine in subjects with the stable dose of Buprenorphine.

IND number: 101,943

Primary purpose: Other: Phase 1 Clinical Pharmacology drug interaction study in healthy subjects

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Subject must be on stable Methadone or Buprenorphine regimens for at least 28 days prior to screening

Exclusion Criteria:

* Subjects must be healthy except for history of Methadone or Buprenorphine treatment regimens
* Prior exposure to DCV, ASV or BMS-791325 within 3 months of screening or any other investigational drug or placebo within 4 weeks of study drug administration
Effects of Gongs Mobilization vs Reverse Distraction Technique in Diabetic Patients With Adhesive Capsulitis

Adhesive capsulitis (AC) represents a renowned musculoskeletal condition which has been clinically classified as frozen shoulder (FS). Adhesive capsulitis occurs 3-5% of the time in the general population, but in diabetics, the frequency can reach 20%. This study is being conducted to determine the effects of gongs mobilization vs reverse distraction technique in diabetic patients with adhesive capsulitis. This study will be a randomized control trial and data will be collected from Haq Orthopedic Hospital. Sample size is 20 calculated by using G power and adding 20 % attrition.

Non-Probability convenient sampling will be used. Participants meeting the inclusion and exclusion criteria will be divided into two groups.10 subjects in group A will be treated Gongs mobilization and group B will be treated with Reverse distraction technique. Conventional therapy will be given to both groups as base line treatment. Both groups have 4 sessions per week for 4 weeks. All participants will be evaluated before and after the treatment using Numeric Pain Rating scale (NPRS), Shoulder pain and Disability Index (SPADI) and goniometer.

Eligibility Criteria:
Inclusion Criteria:

* Both males and females.
* Diagnosed case of Unilateral Adhesive Capsulitis.
* Age group of 40-60 years.
* Stage 2 and 3 of Adhesive Capsulitis.
* Diabetes Mellitus Type II.
* Patients with decreased ROM (less than or equal to 120 degrees), pain, and mild to moderate levels of type II diabetics (below or equal to 200 mg/dL).
* No history of shoulder surgeries to the affected shoulder.

Exclusion Criteria:

* Systemic arthritic conditions of the shoulder (Rheumatoid arthritis, osteoporosis or malignancies in the shoulder region) .
* Disorders of the Cervical spine .
* Corticosteroids injections in the affected Shoulder in preceding 6 weeks.
* Skin lesions or bruises around the Shoulder.
* Shoulder injuries such as Rotator cuff tear.
* Fracture in and around the shoulder joint.