bioihbjkbjnl/mcl2 huggingface dataset:
Pregnenolone in the Management of Schizophrenia Patients
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      Pregnenolone is a "neurosteroid" and possesses intrinsic behavioral and brain effects in
      animals, affecting the GABA(A) and other receptors. Pregnenolone is serves as the precursor
      for dehydroepiandrosterone (DHEA) and its sulfate ester (DHEAS). There is evidence of
      efficacy of DHEA augmentation in schizophrenia, we therefore sought to examine the efficacy
      of augmentation of antipsychotic treatment of schizophrenia patients with pregnenolone. It is
      hypothesized that the combined effect of antipsychotic agents and pregnenolone would be
      beneficial in the treatment of negative,depressive, and cognitive symptoms.
    

Detailed description: 
      Either pregnenolone (30 mg/d or 200 mg/d), DHEA (400 mg/d)or placebo will be added to regular
      treatment for 8 weeks. Subjects will be assessed at baseline and after 2, 4, 6 and 8 weeks of
      treatment. An extensive battery of research instruments will be used for assessment of the
      following domains of interest: psychopathology, insight, side effects, and cognitive
      functions. Plasma pregnenolone, DHEA(S), cortisol and other relevant steroids will be assayed
      at baseline, 2, 4, 6 and 8 weeks of treatment. Efficacy and safety of augmentation of
      antipsychotic treatment with pregnenolone will be analyzed.
    

Intervention name(s): Pregnenolone
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Schizophrenia; Pregnenolone; Neurosteroids
Effect of Two Multiple-dose Regimens of BIA 3-202 on the Pharmacokinetics and Motor Response of Levodopa, and on the Erythrocyte Comt Activity in Parkinson's Disease Patients
Condition: Parkinson's Disease (PD)
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effect of two different multiple-dose regimens
      of nebicapone in comparison to placebo and entacapone 200 mg on the pharmacokinetics of
      levodopa in Parkinson's Disease (PD) patients.
    

Detailed description: 
      STUDY DESIGN AND METHODOLOGY:

      This was a multicentre, randomised, double-blind, placebo- and active-controlled, four-way
      crossover study. The study consisted of 4 treatment periods in at least 16 patients with PD
      treated with standard release levodopa/carbidopa (Sinemet®). Patients were randomly assigned
      to treatment with placebo, nebicapone 75 mg, nebicapone 150 mg or entacapone 200 mg (Comtan®)
      in 4 different sequences.
    

Intervention name(s): Placebo; BIA 3-202; Comtan®; Sinemet®
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Matching placebo capsules; Capsules containing nebicapone 75 mg or 150 mg; Capsules containing entacapone 200 mg; levodopa/carbidopa (Sinemet®) dose patient used to take
Other intervention name(s): Nebicapone; Entacapone; levodopa/carbidopa
Intervention MeSH terms: Levodopa; Carbidopa; Carbidopa, levodopa drug combination; Entacapone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Emergency Ultrasound of the Gallbladder
Condition: Gallbladder Diseases
MeSH terms: Gallbladder Diseases; Emergencies
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether fasting for 8 hours prior to
      ultrasonography for cholelithiasis (gallbladder pain) is needed.
    

Detailed description: 
      Ultrasonography of the gallbladder is currently the diagnostic modality of choice in
      determining cholelithiasis and cholecystitis. Historically this test has been performed in
      the Radiology suites where the patient was expected to fast for times of six to ten hours.
      Patients presenting to emergency departments (ED) have also been required to wait to have
      their study performed in order to have better visualization of the gallbladder. However, few
      studies have examined whether a fasting time matters in determining gallbladder pathology.
      Furthermore, with the emphasis on through-times in the ED, most EDs cannot afford holding
      their patients in the ED to wait for a test. Finally, with the advent of emergency bedside
      ultrasonography and the greater level of comfort emergency physicians (EP) have in diagnosing
      gallbladder pathology, it is possible to now determine an answer within minutes. We will test
      to see if EPs trained in the use of emergency bedside ultrasound can effectively and
      efficiently determine gallbladder pathology and if fasting has an impact on their ability to
      perform a quality ultrasound.
    

Intervention name(s): Ultrasound
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single
Primary purpose: Diagnostic
Keywords: Gallbladder; Ultrasound; Emergency Medicine
Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Six hundreds patients with chronic hepatitis B clinically diagnosed as compensated liver
      cirrhosis are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the
      other is entecavir alone for the first 0.5 year, entecavir plus thymosin-α for 1 year,
      entecavir for another additional 0.5 year.Patients will be assessed at baseline, at every six
      months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver
      ultrasonography, and Fibroscan;
    


Intervention name(s): Entecavir; Thymosin-α
Intervention type(s): Drug; Drug
Intervention description(s): anti-viral therapy; anti-viral and antitherapy
Other intervention name(s): Entecavir dispersible tablets; Zadaxin
Intervention MeSH terms: Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Liver Cirrhosis; Hepatitis B; Compensation; Efficacy
Stem Cell Therapy in IschEmic Non-treatable Cardiac Disease
Condition: Heart Failure
MeSH terms: Heart Failure; Heart Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the SCIENCE study is, in an international multicentre double-blind
      placebo-controlled study, to investigate efficacy of direct intra-myocardial injection of 100
      mio. allogeneic Cardiology Stem Cell Centre_adipose derived stem cells (CSCC_ASCs) in
      patients with reduced left ventricular Ejection Fraction (EF) (≤45%) and heart failure.
    

Detailed description: 
      The aim of the SCIENCE study is, in an international multicentre double-blind
      placebo-controlled study, to investigate efficacy of direct intra-myocardial injection of 100
      mio. allogeneic Cardiology Stem Cell Centre_adipose derived stem cells (CSCC_ASCs) in
      patients with reduced left ventricular EF (≤45%) and heart failure.

      The primary objective is to investigate the regenerative capacity of direct intra-myocardial
      injection of 100 mio. allogeneic CSCC_ASCs in patients with reduced left ventricular EF
      (≤45%) and heart failure in a double-blind placebo-controlled design.

      A total of 138 patients with will be enrolled in the study and treated in a 2:1 randomization
      with either CSCC_ASC or placebo (saline).
    

Intervention name(s): CSCC_ASC
Intervention type(s): Biological
Intervention description(s): The stem cells will be injected directly into the myocardium using the NOGA XP system (BDS, US)
Other intervention name(s): Cardiology Stem Cell Centre_adipose derived stem cells
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart failure; stem cell; adipose derived stem cell; Stem cell therapy; ischemic heart disease
Outpatient Cardiac Rehabilitation in Austria
Condition: Heart Disease
MeSH terms: Heart Diseases
Study type: Observational

Summary: 
      The aim of this prospective trial is the manifestation of guidelines developed for outpatient
      cardiac rehabilitation in Austria.

      The evaluation of prospective and retrospective data is supposed to give evidence on
      morbidity and/or mortality advantages compared to patients not participating in cardiac
      rehabilitation programs.

      The database created in this context is supposed to pave the way as instrument to document
      and comprehend quality and cost effectiveness of outpatient cardiac rehabilitation in Austria
      as a key for quality management.
    


Intervention name(s): Physical activity
Intervention type(s): Other
Intervention description(s): 50min of endurance training combined with 45min of calisthenics; 1-3x/week; 6-24 weeks
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Any patients with heart disease willing to participate in an ambulant cardiac
        rehabilitation.
Effects of Salmeterol on Autonomic Nervous System
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a 4-week non-randomized, partially blinded, single-arm monocentre study in subjects
      with Chronic Obstructive Pulmonary Disease (COPD) Global Initiative for Chronic Obstructive
      Lung Disease (GOLD) class II or III with the aim to demonstrate that inhaled therapy with
      salmeterol reduces sympathetic activity as evaluated by microneurography. A maximum of 32
      subjects is planned to be enrolled.
    

Detailed description: 
      This is a 4-week non-randomized, partially blinded, single-arm monocentre study in subjects
      with COPD GOLD class II or III with the aim to demonstrate that inhaled therapy with
      salmeterol reduces sympathetic activity as evaluated by microneurography. A maximum of 32
      subjects is planned to be enrolled.

      During a complex data registration period comprising the continuous recording of muscle
      sympathetic nerve activity (MSNA) and respiration and of various other measurements at Visit
      1, placebo and 50 μg of salmeterol via Diskus™ inhaler will be administered in a sequential
      design. Following Visit 1, the subjects will be treated with salmeterol 50 μg twice daily via
      Diskus inhaler for 4 weeks. At the Final Visit (Visit 2) the data registration period of
      Visit 1 will be repeated with the only difference that no placebo will be administered.

      Further endpoints, besides the evaluation of MSNA, include heart rate variability (HRV),
      spontaneous baroreflex sensitivity and lung function parameters.

      Study enrolment will be stopped when valid MSNA data on the immediate effect of inhalation
      (manoeuvres at Visit 1) are available for 24 subjects.
    

Intervention name(s): Salmeterol
Intervention type(s): Drug
Intervention description(s): At visit 1 the sympathetic activity will be registered using microneurographic recordings of efferent muscle sympathetic nerve activity (MSNA) in the peroneal nerve and respiration over 2 hours, after 20 minutes of recording, 1 dose of placebo will be administered and after a further recording period of 45 minutes a dose of salmeterol 50 µg will be administered which will be followed by a further period of data registration. At visit 2 following 4 weeks of inhaled treatment with salmeterol the same procedures will be performed but a placebo inhalation will not be performed.
Intervention MeSH terms: Salmeterol Xinafoate
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: influence of bronchodilatation with salmeterol on the autonomic nervous systems in COPD patients will be measured using MSNA.; Relation of COPD and sympathetic nerve activity is to be evaluated,
CLINICAL PHASE III STUDY TO MONITOR THE SAFETY, TOLERABILITY AND EFFICACY OF SUBCUTANEOUS HUMAN IMMUNOGLOBULIN (OCTANORM) IN PATIENTS WITH PRIMARY IMMUNODEFICIENCY DISEASES, INCLUDING (BUT NOT LIMITED TO) THOSE WHO HAVE COMPLETED THE SCGAM-01 TRIAL
Condition: Primary Immunodeficiency
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      Summary for SCGAM-03: Clinical phase III study to monitor the safety, tolerability and
      efficacy of subcutaneous human immunoglobulin (Octanorm) in patients with primary
      immunodeficiency diseases who have completed the SCGAM-01 trial.

      Summary for SCGAM-03 in Canada: Clinical phase III study to monitor the safety, tolerability
      and efficacy of subcutaneous human immunoglobulin (octanorm) in patients with primary
      immunodeficiency diseases, including (but not limited to) those who have completed the
      SCGAM-01 trial
    


Intervention name(s): Octanorm 16.5%
Intervention type(s): Drug
Intervention description(s): Human normal immunoglobulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
CD Patients Immune Status Evaluation
Condition: Severe Crohn's Diease
Study type: Observational

Summary: 
      Using single cell sequencing method to evaluate and compare the immune status of patients
      with severe CD.
    


Intervention name(s): colonic tissue biopsy
Intervention type(s): Other
Intervention description(s): colonic tissue biospy of patients with severe crohn's disease using colonoscopy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The patients were diagnosed as severe CD based on clinical, laboratory, endoscopic changes
        and imging.
      
Biospecimen description: 
      Using the biospy samples of right colon or the last segment of ileum (both inflammation area
      and normal area nearby of 5cm), when patients receiving colonoscopy.
    
Keywords: singcel cell sequencing
Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will examine SPD489 in subjects aged 18-65 with major depressive disorder (MDD)
      who are taking certain types of antidepressants but continue to have residual depression
      symptoms. Eligible patients will remain on their antidepressant but will be randomized to
      either receive supplemental SPD489 or placebo (i.e. sugar pill). The purpose of this study is
      to help answer the following questions:

        -  How safe is SPD489 for the supplemental treatment of depression and what are the side
           effects that might be related to it?

        -  Can supplemental SPD489 help patients who still have residual depression symptoms while
           taking an antidepressant?

        -  How much SPD489 should be given to patients with depression who are also taking an
           antidepressant?

        -  How does SPD489 compare to placebo in depressed patients who are also taking an
           antidepressant?
    


Intervention name(s): SPD489 (Lisdexamfetamine dimesylate ); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + SPD489 (oral, 20, 30, 50 or 70 mg, once daily) for 8 weeks; Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks
Other intervention name(s): Vyvanse
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Nighttime Dosing of Antihypertensive Drugs in Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2; Hypertension
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to investigate if it is possible to lower the nighttime blood
      pressure in patients with type 2 diabetes mellitus by shifting the administration of
      antihypertensive drugs from morning to nighttime.
    

Detailed description: 
      In recent years several studies have shown that high nighttime blood pressure is associated
      with increased cardiovascular risk independently of the average 24 hour blood pressure. As a
      consequence there has been increasing focus on nighttime blood pressure and how to lower it.
      One way of addressing the problem is to shift the administration of antihypertensive drugs
      from morning to nighttime. Studies on non-diabetic patients show that by doing this the
      nighttime blood pressure can be lowered with 3-5 mm Hg without negative effect on the 24 hour
      blood pressure.

      Only recently a study was made on diabetic patients. This showed similar results as for
      non-diabetic patients.However this study was based on diabetic patients who did not receive
      any antihypertensive drugs before.

      This study will investigate the effects on nighttime blood pressure when shifting
      administration of antihypertensive drugs from morning to nighttime. The population is
      diabetic patients who are already in antihypertensive treatment.
    

Intervention name(s): Change of time of administration
Intervention type(s): Other
Intervention description(s): Change of time of administration
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Central Neuropathic Pain Related to Multiple Sclerosis
Condition: Central Neuropathic Pain in Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Neuralgia; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Dronabinol is effective and safe in
      relieving central neuropathic pain in multiple sclerosis patients.
    

Detailed description: 
      Multiple sclerosis (MS) is in all probability an autoimmune disease causing severe
      neurological disability due to inflammation and degeneration in the central nervous system
      (CNS). MS affects over 1 million people worldwide. Central neuropathic pain is associated
      with approximately 30% of all patients with MS. MS-accompanying pain has a major impact on
      the patients' quality of life as usual conventional analgesics are little effective. The aim
      of this clinical study is to determine whether Dronabinol is effective and safe in relieving
      central neuropathic pain in multiple sclerosis patients.
    

Intervention name(s): Dronabinol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral solution, daily dose up to 15 mg, treatment up to 2.5 years; oral solution
Other intervention name(s): (-)trans-delta9-tetrahydrocannabinol
Intervention MeSH terms: Dronabinol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dronabinol; (-)trans-delta9-tetrahydrocannabinol; central neuropathic pain; multiple sclerosis; analgesic; Central neuropathic pain related to multiple sclerosis
Effect of Potato Fiber on Appetite and Fecal Fat Excretion
Condition: Fecal Fat Increased; Obesity; Appetite
MeSH terms: Steatorrhea
Study type: Interventional

Summary: 
      Results have indicated that some dietary fibers increase fecal fat excretion and particularly
      viscous fibers suppress appetite sensation and reduce energy intake. Both these effects may
      contribute to body weight management.

      Aim: The aim of the study is to investigate the potential of 3-weeks daily intake of potato
      pulp (FiberBind), rhamnogalacturonan I isolated potato fiber (RG-I) vs. a low-fiber control
      (placebo) on satiety and fecal fat excretion in healthy adults. Furthermore, a number of
      secondary endpoints are investigated.
    


Intervention name(s): FiberBind; RG-I fiber; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Potato pulp consisting of 68% fiber (5.5 soluble, 76.7% insoluble and 17.8% resistant starch), 9.7% water, 0.3% fat, 7.2% protein and 14% carbohydrates (starch).; Soluble fiber extracted from potato pulp consisting of 95% fiber and 5% water.; Low-fiber control
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
The Comparison of XELOX and EOX in the First-line Treatment of Advanced Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to compare the efficacy and safety of XELOX regimen with EOX regimen
      in the first-line treatment of advanced gastric cancer patients.
    

Detailed description: 
      This study is designed to compare the efficacy and safety of XELOX regimen with EOX regimen
      in the first-line treatment of advanced gastric cancer patients.
    

Intervention name(s): Epirubicin; Oxaliplatin; Capecitabine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50mg/m2 ivgtt d1; 1000mg/m2 po d1-14
Other intervention name(s): 130mg/m2 ivgtt d1; Xeloda
Intervention MeSH terms: Capecitabine; Oxaliplatin; Epirubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prenatal Pilates Assisted Childbirth Preparation Training and Incontinence
Condition: Incontinence, Urinary; Training Group, Sensitivity
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional

Summary: 
      A randomized controlled trial was made to determine the effectiveness of prenatal
      pilates-supported childbirth preparation training on birth outcomes, incontinence during
      pregnancy, and the postpartum period.
    

Detailed description: 
      One of the risk factors for the development of stress incontinence in women is pregnancy and
      childbirth. This problem increases as pregnancy progresses and continues in the postpartum
      period.

      It was tested the hypothesis, there is no difference in the development of urinary
      incontinence in the prenatal and postpartum periods among women who receive Pilates-assisted
      childbirth preparation training and women who were into the usual care.
    

Intervention name(s): Prenatal Pilates Assisted Childbirth Preparation Training
Intervention type(s): Behavioral
Intervention description(s): Training was given twice a week for two hours a day (one hour of theory, one An hour of exercise = 45 minutes of pregnant plates and 15 minutes of breathing exercises) total eight weeks.
Other intervention name(s): Experimental: Study group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Following recruitment, the pregnant women were divided into a study and a control group by randomization (1:1 randomization)
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Pregnancy pilates; Urinary incontinence; childbirth training