bioihbjkbjnl/mcl2 huggingface dataset:
ICBT for Pain-predominant FGIDs in Children and Adolescents: an Implementation Study.
Condition: Functional Gastrointestinal Disorders; Irritable Bowel Syndrome; Dyspepsia; Functional Abdominal Pain
MeSH terms: Irritable Bowel Syndrome; Gastrointestinal Diseases; Digestive System Diseases; Dyspepsia; Abdominal Pain
Study type: Interventional

Summary: 
      This open trial aims to evaluate feasibility and preliminary effectiveness of an
      internet-delivered CBT-program for children and adolescents with functional gastrointestinal
      disorders when implemented in regular care.
    

Detailed description: 
      Pain predominant functional gastrointestinal disorders (P-FGIDs) are common in children and
      adolescents and associated with impaired quality of life. Our research group have previously
      in a series of efficacy-studies shown that internet-delivered exposure-based CBT leads to
      reduced symptoms and increased quality of life in children and adolescents with P-FGIDs.
      There is therefore reason to investigate how the treatment should be disseminated in regular
      care. This open trial aim to evaluate feasibility and preliminary treatment effects in
      regular care of the internet-delivered CBT-program for children and adolescents with P-FGIDs.

      Method: Open trial with a pretest-posttest-design and no control group. The
      internet-delivered CBT-program is 10 week long and include weekly therapist support,
      consisting of online messages and telephone calls. Assessment points are baseline, weekly
      during treatment, post-treatment and follow-up at 3 months and 6 months after treatment
      completion.

      Analysis: Effect sizes and within-group differences will be calculated in an intent-to-treat
      analysis using Cohens' d and Student's t-test.
    

Intervention name(s): Exposure-based internet-delivered CBT
Intervention type(s): Behavioral
Intervention description(s): The main target in treatment is exposure for abdominal symptoms by reducing avoidance and provoking symptoms. Participants are encouraged to gradually increase the difficulty by combining multiple challenges.
The parents are taught how to reduce the risk for reinforcement of children's symptom behavior, and to support their child to complete the treatment.
All treatment content is delivered over the internet, containing texts, videos, audio-files and examples. The modules are unlocked sequentially as participants worked their way through the treatment.
Therapist support consists primarily of encouragement of any progress made in the treatment and support to find individual exercises.
Intervention model: Single Group Assignment
Intervention model description: Open trial without control group to test feasibility and evaluate preliminary effects.
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy Confirmation Trial of CDP870 as add-on Medication to Methotrexate (MTX) in Japanese Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objective of this trial is to investigate the efficacy (American College of Rheumatology
      20% : ACR20) superiority of two dose regiments of CDP870 versus placebo in combination with
      MTX in active RA patients who have an incomplete response to MTX. The pharmacokinetics and
      immunogenicity profile of CDP870 will also be investigated to assess the extrapolability of
      foreign data to the Japanese population.
    


Intervention name(s): CDP870 400mg; CDP870 200mg; CDP870 100mg; Placebo of CDP870
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 400mg CDP870 given every 2 weeks until Week22 (SC); 400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks until Week22 (SC); 200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks until Week22 subcutaneously(SC); given every 2 weeks until Week22 (SC)
Intervention MeSH terms: Certolizumab Pegol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rheumatoid Arthritis; Certolizumab Pegol; Cimzia
A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A
Condition: Congenital Bleeding Disorder; Haemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted globally. The aim of the trial is to investigate safety, efficacy and
      pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP)
      in children with severe haemophilia A who have undergone treatment with previous factor VIII
      (FVIII) products.
    


Intervention name(s): turoctocog alfa pegol
Intervention type(s): Drug
Intervention description(s): Fixed dose of turoctocog alfa pegol for intravenous injections (i.v.) twice weekly for prophylaxis. In addition, turoctocog alfa pegol will be administered to treat bleeding episodes during the trial period. Bleeding episodes will be treated with doses of 20-75 U/kg body weight.
Other intervention name(s): NNC 0129-0000-1003; N8-GP
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy Study of Iontophoresis and Dexamethasone Phosphate to Treat Anterior Uveitis
Condition: Uveitis, Anterior
MeSH terms: Uveitis; Uveitis, Anterior
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to define a safe and effective dose of iontophoretic delivery of
      dexamethasone phosphate ophthalmic solution using the EyeGate® II Drug Delivery System in
      patients with non-infectious anterior segment uveitis.
    

Detailed description: 
      This is a randomized, double-masked, parallel group, dose-comparison, exploratory study of
      four doses of iontophoretic delivery of dexamethasone phosphate ophthalmic solution in
      patients with non-infectious anterior segment uveitis. The current study will evaluate the
      safety, tolerability, and efficacy of this technology at the four dose levels to determine a
      safe effective dose appropriate for future trials.
    

Intervention name(s): EGP-437 1.6 mA-min at 0.4 with EyeGate® II System; EGP-437 4.8 mA-min at 1.2 mA with EyeGate® II System; EGP-437 10.0 mA-min at 2.5 mA with EyeGate® II System; EGP-437 14.0 mA-min at 3.5 mA with EyeGate® II System
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ocular Iontophoresis with EGP-437 1.6 mA-min at 0.4 mA delivered via EyeGate® II Drug Delivery System; Ocular Iontophoresis with EGP-437 4.8 mA-min at 1.2 mA delivered via EyeGate® II Drug Delivery System; Ocular Iontophoresis with EGP-437 10.0 mA-min at 2.5 mA delivered via EyeGate® II Drug Delivery System; Ocular Iontophoresis with EGP-437 14.0 mA-min at 3.5 mA delivered via EyeGate® II Drug Delivery System
Other intervention name(s): Dexamethasone Phosphate Ophthalmic Solution; Dexamethasone Phosphate Ophthalmic Solution; Dexamethasone Phosphate Ophthalmic Solution; Dexamethasone Phosphate Ophthalmic Solution
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Pharmaceutical Solutions; Ophthalmic Solutions; Dexamethasone 21-phosphate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Iontophoresis; Non-Infectious Acute Anterior Segment Uveitis; Ophthalmology
Breast Displacement and CT Radiation Dose
Condition: Computed Tomography; Radiation Dosage
Study type: Interventional

Summary: 
      The primary hypothesis of this study is that breast displacement out of the direct plane of
      imaging during computed tomography (CT) of the abdomen will reduce effective radiation dose
      to the female breast. Secondary hypotheses are that image noise and artifacts will also be
      decreased.
    

Detailed description: 
      Computed tomography (CT) is a significant source of medical-related radiation, and
      radiation-related cancer risk is increasingly recognized in the medical and lay community.
      One of the groups at greatest risk for radiation-induced malignancies is young females due to
      the radiosensitivity of female breast tissue. Breast tissue frequently lies within the
      imaging plane for CT of the abdomen with limited gain in diagnostic information. We propose
      displacing this breast tissue out of the direct imaging plane will decrease unnecessary
      radiation exposure and may also indirectly improve image quality.

      A device called Chrysalis has been designed and received FDA approval for the purposes of
      displacing female breast tissue during CT.
    

Intervention name(s): Chrysalis breast displacement device
Intervention type(s): Device
Intervention description(s): Chrysalis is a cloth device secured with velcro and buckles around the upper abdomen and chest following manual cephalad breast displacement.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Computed tomography; Radiation dose; Dose reduction; Breast displacement; Chrysalis device; Image quality
Bed Rest, Alternate Daily Fasting and Incretin Effect
Condition: Metabolic Syndrome; Type 2 Diabetes; Critical Illness
MeSH terms: Metabolic Syndrome; Critical Illness
Study type: Interventional

Summary: 
      Bed rest produces insulin resistance in healthy volunteers. In this study the investigators
      aim to investigate the effect of 8 days bed rest on the incretin effect and how alternate
      daily fasting affects cognitive function and the insulin resistance produced by bed rest.

      The subjects will be randomized to either 3 meals a day (isocaloric diet), alternate daily
      fasting or one meal/day every second day (25% of daily calorie need) and four meals/day every
      second (175% of daily calorie need).

      The investigators hypothesize:

        1. Bed rest reduces the incretin effect

        2. Alternate daily fasting improves the cognitive function (memory and concentration)
           compared to isocaloric diet

        3. Alternate daily fasting reduces insulin resistance produced by bed rest compared to
           isocaloric diet
    

Detailed description: 
      All subjects will undergo 8 days of bedrest. Outcome measures will be performed before, under
      and immediately after the bed rest period.

      The individual study period will be 10 days in total.
    

Intervention name(s): Bed rest; OGTT; IVGTT; Cognitive testing; Muscle and fat biopsies; Dual-energy X-ray Absorptiometry (DXA) scan; MRI
Intervention type(s): Other; Other; Other; Other; Other; Other; Other
Intervention description(s): 8 days of full bed rest; Oral glucose tolerance test with 75 g of glucose before and after bed rest; Intravenous glucose tolerance test mimicking the glucose profile from the corresponding OGTT; Daily testing of memory and concentration using standardized tests; Biopsies will be obtained before and after bed rest; DXA scan to evaluate fat and muscle distribution before and after bed rest; Functional MRI to evaluate cognitive function and abdominal MRI to evaluate visceral fat before and after bed rest
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Long Term Follow-up Study at Years 2, 3, 4 and 5 Where 2 Dosing Schedules of the Combined Hepatitis A and B Vaccine Were Compared
Condition: Hepatitis B; Hepatitis A
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the persistence of anti-hepatitis A virus (HAV) and anti-hepatitis B surface
      antigen (HBs) antibodies up to 2, 3, 4 and 5 years after administration of the first dose of
      the study vaccine.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Detailed description: 
      Open, randomised, self-contained, multicentric, multinational, long-term antibody persistence
      studies. Immune persistence was compared between subjects who received either two dose or
      three doses of GSK Biologicals combined hepatitis A and hepatitis B vaccine. The long-term
      follow-up studies involved taking blood samples at approximately 2, 3, 4 and 5 years after
      the primary vaccination of combined hepatitis A and B vaccine to assess antibody persistence.
      No additional subjects will be recruited during the long term follow-up period.
    

Intervention name(s): Twinrix™ Adult; Twinrix™ Junior
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection in the left deltoid, 2 doses, Adult formulation in primary study.; Intramuscular injection in the left deltoid, 3 doses, junior formulation in primary study.
Other intervention name(s): Combined hepatitis A and B vaccine; Combined hepatitis A and B vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Combined hepatitis A and B vaccine; Twinrix™
Lactoferrin and Lysozyme Supplementation for Environmental Enteric Dysfunction
Condition: Environmental Enteric Dysfunction
Study type: Interventional

Summary: 
      Randomized, double-blind, placebo controlled trial of daily lactoferrin and lysozyme
      supplementation in improving environmental enteric dysfunction in Malawian children
    


Intervention name(s): Lactoferrin; Lysozyme; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Lactoferrin; Muramidase
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Femur Transtrochanteric Fractures Treated With Dynamic Hip Screw and Calcium Sulfate Scaffold.
Condition: Proximal Femur Fracture
MeSH terms: Fractures, Bone; Femoral Fractures
Study type: Interventional

Summary: 
      This is a randomised prospective comparison study to evaluate the incidence of cut - out
      failure of the dynamic hip screw implant alone compared to the dynamic hip screw adding
      calcium sulfate through the cervical canal before placing the sliding screw for improvement
      of the implant stability integration and bone healing.
    

Detailed description: 
      Transtrochanteric fractures are a frequent entity, mainly in patients over 65 years old, with
      low bone density. Most of these fractures of the proximal femur are treated effectively with
      internal fixation with dynamic hip screw (DHS), nonetheless a conditional factor in the
      treatment success its in the fracture stability and in the osteoporosis severity.

      There is controversy in the treatment decision in patients with osteoporosis and an unstable
      fracture added the risk of peri-prosthetic infection or increased bleeding during surgery
      means that the decision to place a DHS versus a prosthesis is debated.

      This study represents the first comparison of closed reduction and internal fixation with DHS
      using calcium sulfate graft versus conventional DHS procedure.
    

Intervention name(s): Study group with absorbable graft of tricalcium ß phosphate / calcium sulfate hemihydrate paste
Intervention type(s): Device
Intervention description(s): Application of absorbable graft of tricalcium ß phosphate / calcium sulfate hemihydrate in paste for prevent loosening of Dynamic Hip Screw implant
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A two group comparison
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Dynamic Hip Screw; DHS HIP FRACTURE
Evaluation of the Use of the Atalante System in Patients Presenting a Non-traumatic Hemiplegia in Acute-subacute Phase (15 Days to 6 Months).
Condition: Stroke; Stroke, Acute; Stroke, Subacute; Robotics
MeSH terms: Stroke; Hemiplegia
Study type: Interventional

Summary: 
      The SPIRIT study is interventional, national, prospective, open, bicentric each patient being
      his/her own control.

      It is conducted to assess the safety and performance of the Atalante exoskeleton system in
      patients presenting a non-traumatic acute-subacute hemiplegia. The primary endpoint is
      defined by the patient's ability to perform the 10 MWT with the Atalante system.

      The study will include 16 patients and takes place in two french rehabilitation centers.
    


Intervention name(s): Use of the Atalante exoskeleton
Intervention type(s): Device
Intervention description(s): A session includes a stand-up, walks over a distance of 10 meters, exercises with or without the assistance of the exoskeleton, U-turns and a sitting.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Stroke; Acute Stroke; Subacute Stroke; Robotics; Physiotherapy; Rehabilitation; Powered exoskeleton; Walking; Exercises; Ambulation
Effect of CT1812 Treatment on Brain Synaptic Density
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Study to Evaluate the Safety and Tolerability of Oral CT1812 in Subjects with Mild to
      Moderate Alzheimer's Disease.
    

Detailed description: 
      This is a single-center, randomized, double-blind, placebo-controlled, parallel group study
      of two doses of CT1812 in adults with mild to moderate Alzheimer's Disease to evaluate the
      safety and tolerability of oral CT1812, administered for up 180 days for the Primary study
      and another 180 days for the double-blind extension study.

      Each participant and caregiver participated in a screening period of up to 60 days, followed
      by the primary double-blind treatment period of 24 weeks (169 days +/-2) followed by an
      optional double-blind extension treatment period of another 24 weeks (337 days +/-2).
    

Intervention name(s): Active Treatment- CT1812 100 mg; Active Treatment- CT1812 300 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): CT1812; CT1812; Matching Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
18791 - Sun Protection Factor Assay
Condition: Sunscreening Agent
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor (SPF) efficacy on human skin.
    


Intervention name(s): Coppertone (BAY987517)
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase I Dose Escalation Study of Topotecan and Pazopanib in Children With Recurrent/Refractory Solid Tumours
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a phase I, dose escalation study where topotecan will be administered at lower doses
      given more frequently on a prolonged schedule (low dose metronomic; LDM), in combination with
      pazopanib administered in a specific dose range. The maximum tolerated dose (MTD) and the
      recommended phase 2 dose (RP2D) will be evaluated for LDM topotecan in combination with
      pazopanib in children with recurrent or refractory solid tumours. Pharmacokinetic and
      pharmacodynamic studies will be conducted to further define the exposure to and activity of
      LDM topotecan in combination with pazopanib.
    


Intervention name(s): Topotecan and Pazopanib
Intervention type(s): Drug
Intervention description(s): Low-dose metronomic Topotecan and Pazopanib will be escalated as per the dose escalation schema.
Other intervention name(s): Hycamtin; Votrient
Intervention MeSH terms: Topotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric; Solid Tumour
Efficacy and Safety Study of Sibutramine in Overweight Non-Diabetic Malaysian Population
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study was to evaluate the efficacy and the safety of
      sibutramine vs. placebo in combination with a hypocaloric diet on weight-loss in overweight
      and obese Malaysian subjects.
    


Intervention name(s): Sibutramine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules, Wk 0: 10mg, once daily; Wks 4-24: 10mg or 15mg, once daily, dosage escalation based upon investigator's assessment.; Capsules, once daily
Other intervention name(s): ABT-991; Meridia; Reductil
Intervention MeSH terms: Sibutramine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity
Clinical Study To Evaluate Paired Treatment With An Alexandrite Laser And Radiofrequency Microneedling For Facial Aging
Condition: Wrinkle; Photoaging; Dyschromia
Study type: Interventional

Summary: 
      The intended use of the radiofrequency and microneedling devices used in this study is to
      assess the efficacy and safety of paired treatment for the treatment of facial aging.
    

Detailed description: 
      Subjects are to be enrolled in this clinical study if they are a healthy male or female 40 -
      65 years of age. Up to 35 subjects will be enrolled at 2 study centers. Subjects will attend
      a screening/pretreatment visit which may be performed on the same day as the treatment visit.
      Subjects may receive up to 4 treatments on the face.
    

Intervention name(s): RF device; Microneedling device
Intervention type(s): Device; Device
Intervention description(s): The entire defined treatment area will then be treated by delivering adjacent pulses with minimal overlap of 10% or less. Parameters may be adjusted throughout the treatment in order to increase subject comfort.; Test spots may be performed prior to the first treatment. Test spots may be performed prior to the first treatment. It will follow a similar procedure to treatment but only in an inconspicuous place, such as behind the ear, in an area no larger than 2in x 2in.
The tip will be placed in contact with the skin, and parameters may be adjusted throughout the treatment and will determined by the Clinician.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment