bioihbjkbjnl/mcl2 huggingface dataset:
Study on Abnormal Dopamine Synthesis and Connectivity According to the Antipsychotic Treatment Response in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      The purpose of this study is to evaluate abnormal dopamine synthesis and connectivity
      according to the antipsychotic treatment response in schizophrenia.
    


Intervention name(s): patients treated with antipsychotics
Intervention type(s): Other
Intervention MeSH terms: Antipsychotic Agents
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        1. Schizophrenia patients treated with clozapine

          2. Schizophrenia patients treated with risperidone or paliperidone or olanzapine

          3. Healthy volunteers
Marine Protein Hydrolysate as Dietary Supplement in Elderly Part II
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The aim of this study is to investigate the potential effect of different doses of MPH
      supplement on glucose metabolism, hunger and appetite hormones.
    

Detailed description: 
      The potential use of marine protein hydrolysates (MPH) as a supplement with similar or better
      health benefits than a regular white fish meal, can be regarded both cost-effective,
      environmental friendly and sustainable.

      The aim of this study is to investigate the potential effect of increasing/different doses of
      MPH supplement on glucose metabolism, hunger and appetite hormones in healthy elderly, to
      provide a basis for the optimalization of the daily dose for further use of MPH in clinical
      study protocols in elderly patients with sarcopenia, other inflammatory conditions or
      abnormal glucose metabolism.
    

Intervention name(s): marine protein hydrolysate 1234; marine protein hydrolysate 2134; marine protein hydrolysate 3124; marine protein hydrolysate 4123
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Dietary Supplement for e.g. in this order: MPH 1600 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 800 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 2400 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 3200 mg for 7 days, than 7 days wash-out."; Dietary Supplement for e.g. in this order: MPH 3200 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 800 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 2400 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 1600 mg for 7 days, than 7 days wash-out."; Dietary Supplement for e.g. in this order: MPH 2400 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 3200 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 1600 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 800 mg for 7 days, than 7 days wash-out."; Dietary Supplement for e.g. in this order: MPH 1600 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 800 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 3200 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 2400 mg for 7 days, than 7 days wash-out."
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: A simple open step-up design will be employed with no placebo control, but the sequence will be randomized. Both participant and investigator are blinded for the dose.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Dietary Supplements; Fish Proteins; Protein Hydrolysates; Aged
Pressure Therapy in the Treatment of Upper Arm of Cerebral Palsy Children
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy of a 6 months upper arm proprioceptive
      pressure therapy on Assisting Hand Assessment ("AHA") performance in Cerebral Palsy (CP). To
      perform this study, 80 CP patients aged of 5 to 10 years old will be included in a
      multicentric, double blind, prospective parallel-group randomized study. Treatment will be a
      pressure therapy using a LYCRA® compressive sleeve initially used in burn therapy. Primary
      outcome is to increase of 60% of AHA performance. The secondary outcome are to increase
      Quality of Upper Extremity Skill Test (QUEST), quality of life and improve Somatosensory
      Evoked Potentials (SEP).
    

Detailed description: 
      The purpose of this study is to assess the efficacy of a 6 months upper arm proprioceptive
      pressure therapy on Assisting Hand Assessment ("AHA") performance in Cerebral Palsy (CP). To
      perform this study, 80 CP patients aged of 5 to 10 years old will be included in a
      multicentric, double blind, prospective parallel-group randomized study. Treatment will be a
      pressure therapy using a LYCRA® compressive sleeve initially used in burn therapy. Primary
      outcome is to increase of 60% of AHA performance. The secondary outcome are to increase
      Quality of Upper Extremity Skill Test (QUEST), quality of life and improve Somatosensory
      Evoked Potentials (SEP)
    

Intervention name(s): Proprioceptive pressure therapy; Control
Intervention type(s): Device; Device
Intervention description(s): Proprioceptive pressure therapy using a a LYCRA® compressive sleeve initially used in burn therapy : 15 to 25 mmHg.; LYCRA® non-compressive sleeve initially used in burn therapy : < 5 mmHg.
Other intervention name(s): Proprioceptive pressure therapy by Medical Z
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Upper limb; Proprioceptive pressure therapy; Children; Assisting Hand Assessment performance
Comparison of the Supervised and Home-Based Progressive Resistant Training in Female Total Knee Arthroplasty Patients
Condition: Total Knee Arthroplasty
Study type: Interventional

Summary: 
      Early postoperative rehabilitation programs after TKA aims to provide optimal functional
      recovery. The current rehabilitation process in TKA typically includes 2 to 3 months
      post-surgery, as the greatest declines in strength and functional performance occur
      immediately after surgery. Yet, the content, duration, and intensity of the rehabilitation
      programs for the reorganization of physical function after surgery have not yet been fully
      clarified. Whether home-based rehabilitation is comparable to supervised rehabilitation in
      the midterm period requires further research, as practices after TKA vary. The purpose of
      this study is to compare the effectiveness of supervised and home-based progressive
      resistance training (PRT) in the midterm postoperative period in female patients undergoing
      TKA.
    

Detailed description: 
      The objective of this study is to compare the pain, quadriceps strength, knee function, joint
      awareness, and quality of life between supervised or home-based PRT at 3 months after the
      total knee arthroplasty.

      The study design is a single-blinded randomized trial. Both groups received standard
      physiotherapy for three months. In the third month postoperatively, supervised and home-based
      PRE, which consisted of sixteen sessions of exercise lasting eight weeks initiated. The
      clinical outcomes were compared at baseline (third month postoperatively) and the fifth month
      postoperative.

      The clinical outcomes consisted of pain, range of motion (ROM), quadriceps and hip abductor
      muscle strength, and WOMAC (Western Ontario and McMaster University Arthritis Index ) score.
      The performance-based activity limitation test consisted of the 30-second sit-to-stand test,
      the 40-meter fast-paced walk test and the 9-step stair climb test. Joint awareness was
      assessed with Forgotten Joint Score-12 (FJS12). The quality of life was evaluated with the
      World Health Organization Quality of Life Instrument, Short Form (WHOQOL-BREF).
    

Intervention name(s): Supervised progressive resistance training; Home-based progressive resistance training
Intervention type(s): Procedure; Procedure
Intervention description(s): Exercises were performed with cable resistance training machine; In the first session, with the help of a physiotherapist, strengthening exercises were shown and taught to the patients. Two weeks after the beginning of the home-based PRT program, patients were called to check whether they were doing the exercises in the home program correctly. After the checking for exercise training, the patients were called by phone every two weeks for follow-up.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Exercise Training Program for Cerebellar Ataxia
Condition: Cerebellar Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a person's ability to adapt (i.e. short
      term motor learning) predicts their ability to benefit from physical therapy exercises.
    

Detailed description: 
      The cerebellum is important for coordination of movement and for motor learning. No
      medications systematically improve cerebellar ataxia, and little is known about the
      effectiveness of rehabilitation exercises, which are often the only treatment option. Here,
      we ask whether a person's ability to adapt (i.e. short term motor learning) predicts their
      ability to benefit from physical therapy exercises. This pilot-clinical trial will test a
      subject's ability to adaptively learn a new walking pattern in a single session, and then any
      improvement of walking and balance over a 13 week time period during which they participate
      in a specialized home exercise training program. Our prediction is that those individuals
      with some preserved adaptive learning ability will be the best rehabilitation candidates.
    

Intervention name(s): Home exercise program
Intervention type(s): Behavioral
Intervention description(s): The home exercise program uses standard physical therapy exercises that have never been rigorously tested for people with cerebellar ataxia. These include sitting balance exercises (e.g. sitting on a peanut-shaped exercise ball and moving arms or legs), standing balance exercises (e.g. weight shifting, moving arms and legs), and walking exercises (e.g. walking heel-to-toe). The exercises are in a progression, going from less to more challenging. Though the exercises are standard, they are the intervention that we are testing and we will consider them experimental.
Other intervention name(s): Woodway Split Belt Treadmill; Company: Woodway USA, Inc
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ataxia; exercise; training; cerebellar; rehabilitation
Optimized Chemotherapy Followed by Maintenance With Bevacizumab With or Without Erlotinib in Treating Patients With Metastatic Colorectal Cancer That Cannot be Removed by Surgery (DREAM)
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      PURPOSE: This randomized phase III trial is studying maintenance therapy with bevacizumab
      alone after an induction therapy combining bevacizumab+chemotherapy to see how well they work
      compared to maintenance therapy with bevacizumab+erlotinib alone after an induction therapy
      combining bevacizumab+chemotherapy in treating patients with metastatic colorectal cancer
      that cannot be removed by surgery.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare Progression-free survival during maintenance period ("Maintenance PFS")in
           patients with unresectable metastatic colorectal cancer.

      Secondary

        -  Compare the duration of disease control and overall survival of patients treated with
           these regimens.

        -  Compare the tolerability of these regimens in these patients.

        -  Compare the quality of life of patients treated with these regimens.

        -  Compare the occurrence of secondary surgery in patients treated with these regimens.

        -  Compare the chemotherapy-free intervals and response rates in patients treated with
           these regimens.

      INDUCTION THERAPY

      Bevacizumab IV over 30-90 minutes on day 1, combined with either:

        -  modified FOLFOX7 (IV : oxaliplatin, folinic acid, fluorouracil),

        -  XELOX2 (IV : oxaliplatin, oral capecitabine day 1 to 8),

        -  FOLFIRI (IV : irinotecan, folinic acid, fluorouracil).

      Treatment repeats every 2 weeks.

      RANDOMIZATION Patients with stable or responding disease then receive maintenance therapy
      with bevacizumab alone or bevacizumab+erlotinib

      MAINTENANCE THERAPY

        -  Arm A : bevacizumab alone : bevacizumab IV over 30-90 minutes on day 1

        -  Arm B : bevacizumab+erlotinib : bevacizumab IV over 30-90 minutes on day 1 and oral
           erlotinib once daily on days 1-21.

      In both arms, treatment with bevacizumab +/- erlotinib repeats every 3 weeks in the absence
      of disease progression or unacceptable toxicity.

      ACCRUAL: A total of 700 patients will be accrued for this study.
    

Intervention name(s): bevacizumab; bevacizumab, erlotinib
Intervention type(s): Drug; Drug
Intervention description(s): bevacizumab 7.5mg/kg every 3 weeks until disease progression or limiting toxicity; bevacizumab 7.5mg/kg and oral erlotinib 150 mg/day continuously Cycles every 3 weeks until disease progression or limiting toxicity
Intervention MeSH terms: Bevacizumab; Erlotinib Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV colon cancer; stage IV rectal cancer; adenocarcinoma of the colon; adenocarcinoma of the rectum; chemotherapy
A Study to Evaluate Chronic Hepatitis C Infection in Treatment Experienced Adults
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and
      ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as
      dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected
      treatment-experienced adults.
    


Intervention name(s): ABT-450/r/ABT-267, ABT-333; Ribavirin; Placebo for ABT-450/r/ABT-267; Placebo for ABT-333; Placebo for ribavirin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet; Capsule (double-blind treatment period), tablet (open-label treatment period); Tablet; Tablet; Capsule
Other intervention name(s): ABT-267 also known as ombitasvir; ABT-450 also known as paritaprevir; ABT-333 also known as dasabuvir; Viekira PAK
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hepatitis C; Treatment-Experienced; Null responder; Partial Responder; Chronic Hepatitis; Hepatitis C Genotype 1; Interferon-Free; Hepatitis C Virus; Relapser; Non responder; Viekira Pak; ombitasvir; ribavirin; ritonavir; paritaprevir; dasabuvir
Sotagliflozin Multiple-dose Study in Healthy Chinese Subjects
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To assess the safety and tolerability of sotagliflozin after a multiple oral dose
      administration in Chinese healthy subjects.

      Secondary Objectives:

        -  To assess the pharmacokinetic (PK) parameters of sotagliflozin after a multiple oral
           dose administration in Chinese healthy subjects.

        -  To assess the pharmacodynamics (PD) parameters of absolute urinary glucose excretion
           after a multiple oral dose administration in Chinese healthy subjects.
    

Detailed description: 
      The study duration per subject will be up to 41 days and will consist of a screening period
      of up to 28 days, a dosing period of 8 days, and a follow up visit 5 days after last dosing.
    

Intervention name(s): Sotagliflozin (SAR439954); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: tablet
Route of administration: oral; Pharmaceutical form: tablet
Route of administration: oral
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Amino Acid Addition to a Drink on the Appearance of Ingested Water in Body Fluids
Condition: Rate of Water Appearance/Delivery in the Blood Water Balance
Study type: Interventional

Summary: 
      To determine the effects of a moderate amount of amino acids on the rate of water absorption
      and availability as a precursor fluid for sweat. Young and healthy (male or female)
      volunteers will take part in three experimental trials. In each trial, volunteers will be
      given one of two commercially available sports drinks or a commercially available sport drink
      with added amino acids in a double-blinded, randomised, crossover design. Each drink will be
      a single 550 mL bolus. All beverages will be labelled with deuterium (D2O). Trials will be
      compared for temporal accumulation of deuterium in plasma over the course of 60 minutes.
      Whole blood measurements of haemoglobin and haematocrit will also be made and plasma volume
      changes calculated. It is hypothesised that the amino acid trial will increase the rate of
      fluid absorption.
    


Intervention name(s): Composition of Sports Drink
Intervention type(s): Other
Intervention description(s): The composition of sport drinks will be manipulated to determine the effect of drink composition on the appearance of ingested water in body fluid.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double-blind, randomised, crossover design
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
VEST III PMS Clinical Protocol
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional

Summary: 
      Post marketing surveillance (PMS) study. 200 patients will be enrolled in a prospective,
      multi center, randomized, two-arm, open label, and controlled, enrolling patients with multi
      vessel atherosclerotic coronary artery disease, scheduled to undergo Coronary artery bypass
      grafting (CABG) with arterial grafting of IMA to LAD, one saphenous vein graft (SVG) to the
      right territory and one or more SVGs to the left territory. Of all vein grafts, one will be
      selected randomly to receive treatment with VEST and another designated Control.
    


Intervention name(s): VEST External Support; Coronary Artery Bypass Surgery
Intervention type(s): Device; Procedure
Other intervention name(s): CABG
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
NasoNeb Delivery of an Intranasal Steroid
Condition: Perennial Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to see if a nasal steroid drug delivered to the nose with the
      NasoNeb™ inhaler improves the symptoms of people with perennial allergic rhinitis (year round
      allergy symptoms).
    


Intervention name(s): Budesonide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily; Placebo delivered intranasally via NasoNeb nebulizer once daily
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: allergy
Efficacy of Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets on the Patients With Newly Diagnosed Type 2 Diabetes Mellitus Combined With Non-alcoholic Fatty Liver Disease
Condition: Type 2 Diabetes Mellitus; Non-alcoholic Fatty Liver Disease; Efficacy
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an multicenter, randomized, double-blind, parallel-controlled study to evaluated the
      efficacy of pioglitazone hydrochloride and metformin hydrochloride tablets on the patients
      with newly diagnosed type 2 diabetes mellitus combined with non-alcoholic fatty liver
      disease.
    

Detailed description: 
      Taking metformin monotherapy as a control, we evaluated the efficacy of pioglitazone
      hydrochloride and metformin hydrochloride tablets on hepatic fat ultrasound and liver enzyme
      levels, and observed whether the drug can improve fatty liver in patients with newly
      diagnosed type 2 diabetes combined with non-alcoholic fatty liver disease. This is an
      multicenter, randomized, double-blind, parallel-controlled study.
    

Intervention name(s): Combination of Pioglitazone and Metformin Tablets; Metformin Hydrochloride Tablets
Intervention type(s): Drug; Drug
Intervention description(s): 15mg/500mg, oral, 2/day; Oral metformin 850mg, 2/day in the control group
Other intervention name(s): ka shuang ping; ge hua zhi
Intervention MeSH terms: Metformin; Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets; Randomized Controlled Trial; Non-alcoholic Fatty Liver Disease