bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Dose Response Relationship, Safety and Efficacy of GSK1278863 in Hemodialysis-dependent Subjects With Chronic Kidney Disease Associated Anemia
Condition: Anaemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is intended to evaluate the dose-response relationship of GSK1278863 over the
      first 4 weeks of treatment and evaluate the safety and efficacy of GSK1278863 over 24 weeks
      to maintain hemoglobin (Hgb) level in hemodialysis-dependent (HDD) subjects with anemia
      associated with chronic kidney disease (CKD) who are switched from a stable dose of
      recombinant human erythropoietin (rhEPO). The data generated will enable selection of the
      starting dose(s) and optimize dose adjustment regimen(s) for Phase 3 clinical trials.
    


Intervention name(s): GSK1278863; Placebo; rhEPO
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Film coated tablets containing 1 mg, 2 mg, 5 mg, or 25 mg of GSK1278863; Matching placebo tablet for GSK1278863; rhEPO will be procured from local market
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hemoglobin; recombinant human erythropoietin; Chronic kidney disease; hemodialysis; pharmacokinetics; erythropoiesis stimulating agents; Anemia; GSK1278863
Interscalene Dynamometer Pilot Study
Condition: Total Shoulder Arthroplasty
Study type: Observational

Summary: 
      Total shoulder arthroplasty (shoulder replacement) can cause severe postoperative pain.
      Commonly, patients receive general anesthesia with interscalene block (injection of local
      anesthetic or numbing medicine near nerves in the shoulder) during surgery. As a result of
      the interscalene block, patients often experience sensory and motor blockade. The purpose of
      this study is to determine the effects of the interscalene block on the anterior deltoid
      muscle and hand grip strength after total shoulder arthroplasty.
    

Detailed description: 
      Total shoulder arthroplasty can cause severe postoperative pain. Pain management includes
      general anesthesia with interscalene block during surgery and intravenous (IV) hydromorphone
      patient controlled analgesia (PCA) and oral opioid analgesics given after surgery. Side
      effects, such as motor blockade, may impair participation in physical therapy and diminish
      patient satisfaction. In order to prepare for a future study that will examine what mixtures
      of adjuncts/additives will best prevent recovery room pain and minimize motor blockade, the
      investigators are conducting this pilot study to collect preliminary data on current
      practice. The investigators believe the current regimen will provide adequate pain relief,
      but may cause extensive motor blockade and reduce patients' muscle strength after surgery.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients 18-80 years old who are undergoing primary total shoulder arthroplasty.
Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression
Condition: Affective Disorders
MeSH terms: Mental Disorders; Psychotic Disorders; Mood Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to compare ziprasidone (Geodon) monotherapy for the treatment of
      psychotic major depression (PMD)with an antidepressant/antipsychotic combined therapy.
    

Detailed description: 
      Psychotic depression is a well-established DSM-IV diagnostic subtype indicating the presence
      of hallucinations and/or delusions as part of the clinical presentation. Currently the
      treatment of choice for psychotic depression is either electroconvulsive therapy or
      combination of antipsychotic and antidepressant medications. Ziprasidone will be compared to
      standard of care treatment comprising a combination of an antidepressant, sertraline and an
      antipsychotic, haloperidol, over a 12-week period. An additional 12-week extension phase is
      also included for responders to the initial study.
    

Intervention name(s): Ziprasidone; Sertraline; Haloperidol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Target dosage 120-160mg/day based on tolerance; Target dosage 150-200mg/day based on tolerance.; Target dosage 6-8mg/day based on tolerance.
Other intervention name(s): Geodon; Zoloft; Haldol
Intervention MeSH terms: Haloperidol; Haloperidol decanoate; Ziprasidone; Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psychotic
An Intervention With Weighted Blankets for Children With ADHD and Sleep Problems
Condition: Adhd; Sleep Disturbance
MeSH terms: Dyssomnias; Parasomnias
Study type: Interventional

Summary: 
      The aim of the study is to evaluate a sleep intervention with weighted blankets for children
      with ADHD and sleep problem regarding health-related outcomes, sleep, and cost-effectiveness.

      The study is an RCT with cross-over design. The participants will be randomized to start with
      an active or placebo blanket, and then change blankets during the 16 week study period.
    

Detailed description: 
      There is limited evidence about health outcomes or health-economic benefits of sleep
      interventions with weighted blankets for children with neuropsychiatric syndromes (NPS).

      The aim of the study is to evaluate a sleep intervention with weighted blankets for children
      with ADHD and sleep problem regarding health-related outcomes, sleep, and cost-effectiveness.

      The participants, n=100 children between 6 and 13 years old, will be recruited from the ADHD
      unit in Child and Adolescent Mental Health Service (CAMHS) and randomly assigned into two
      groups: Fiber Weighted Blankets (intervention 1) and Control Blankets (controls).

      The children will use each blanket respectively for 4 weeks, then change blankets. A long
      term follow-up will be conducted 16 weeks from baseline.
    

Intervention name(s): Weighted fiber blanket
Intervention type(s): Other
Intervention description(s): Using weighted blanket for four weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: children; non-pharmacological intervention; ADHD; sleep
Atorvastatin (Lipitor) Therapy in Patients With Clinically Isolated Syndrome (CIS) at Risk for Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients who have been diagnosed with clinically isolated syndrome (CIS) often develop
      problems related to the central nervous system, which controls the nerves in the body. Some
      of these patients may later be diagnosed with multiple sclerosis (MS), a progressive disease
      of the nervous system. The purpose of this study is to determine if the drug atorvastatin is
      helpful to CIS patients.

      Study hypothesis: Early intervention with atorvastatin in patients with CIS will result in a
      state of immunological tolerance.
    

Detailed description: 
      CIS is a single clinical event indicating temporary disruption of normal nerve function. CIS
      patients may have a loss of vision in one eye; trouble with balance; double vision; numbness
      in the face; and tingling, numbness, or weakness in the arms or legs. Some CIS patients may
      develop MS, but others may not. Studies have shown that when CIS is accompanied by magnetic
      resonance imaging (MRI)-detected brain lesions that are consistent with those seen in MS,
      there is a high risk of a second neurologic event and a diagnosis of MS within several years.
      This study will evaluate the efficacy of atorvastatin, an antihyperlipidemic, in the
      prevention of MS in CIS patients.

      This study will last 18 months. All participants must complete a 3- to 5-day course of
      corticosteroids at least 28 days before the baseline evaluations. This corticosteroid therapy
      must be initiated within 60 days of CIS onset. Participants will be randomly assigned to
      receive 80 mg of either atorvastatin or placebo by mouth daily for 12 months. Study visits
      will occur at screening and every 3 months thereafter until the end of the 18-month study.
      Blood collection will occur at selected visits, and other additional evaluations will be
      performed at Months 1 and 2. Selected participants will undergo MRI brain scans. Participants
      will be offered interferon beta-1a (Avonex®), free of charge, if they develop disease
      activity. Participants will be instructed to report any change in their health status to
      their treating physician within 48 hours of the onset of symptoms.
    

Intervention name(s): Atorvastatin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): atorvastatin at the dose of 80 mg/day. Participants will be allowed to decrease the daily dose to 40 mg/day if the higher dose is not well-tolerated; tablet form
Other intervention name(s): Lipitor; Placebo Treatment
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Early Multiple Sclerosis; MS; Clinically Isolated Syndrome
A Prospective Non-therapeutic Study in Patients Diagnosed With Niemann-Pick Disease Type C
Condition: Niemann-Pick Disease, Type C
MeSH terms: Pick Disease of the Brain; Aphasia, Primary Progressive; Frontotemporal Dementia; Niemann-Pick Diseases; Niemann-Pick Disease, Type A; Niemann-Pick Disease, Type C
Study type: Observational

Summary: 
      This is a prospective non-therapeutic observational study in NP-C patients. The aim is to
      characterize the individual patient disease progression profile through the historical and 6
      months prospective evaluation of clinical, imaging, biological(biomarkers) and quality of
      life data.

      Patients will be offered enrollment into a Phase II/III study on arimoclomol at the end of
      the study.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        NPC1 and NPC2 patients aged 2-18 years
      
Biospecimen description: 
      Plasma
    
Keywords: NP-C; LSD; lysosomal storage disorder; lysosomal storage disease; NPC2; NPC1; Niemann-Pick Type C; Niemann-Pick,; Arimoclomol
Dual Trigger Versus Booster Dose of HCG
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      To salvage the luteal phase and improve pregnancy rate in antagonist IVF/ICSI cycles
      triggered with GnRH agonist. Two strategies are compared dual trigger with GnRH agonist plus
      1000 IU of HCG or triggering with GnRH and giving a booster dose of HCG (1500 IU) on the day
      of ovum pickup.
    


Intervention name(s): IVF/ICSI; Human Chorionic Gonadotropin
Intervention type(s): Procedure; Drug
Intervention description(s): given in different doses and timing to support the luteal phase
Intervention MeSH terms: Chorionic Gonadotropin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A New Rehabilitation Tool in Fibromyalgia
Condition: Fibromyalgia; Pain
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The aim of the investigators study was to measure reductions in chronic pain in female
      patients with Fibromylgia comparing individual proprioceptive rehabilitation treatments with
      perceptual surfaces to a group exercises rehabilitation. Fibromyalgia is a generalized
      chronic pain condition that is usually accompanied by fatigue, sleep disturbance and
      psychological and cognitive alterations.
    


Intervention name(s): Physical exercises treatment; Perceptive Rehabilitation Treatment; Control group
Intervention type(s): Other; Other; Other
Intervention description(s): Includes different types of exercises: low-impact to moderate aerobic training; walking fast in a circle, alternating with periods of going up and down the stairs (3 steps for 10 minutes) for a total of 20 consecutive minutes; posture exercises for the back and proprioceptive exercises for the trunk in the supine position to improve axial stability, including diaphragmatic breathing. The heart rate was monitored through the use of a heart rate monitor, which allowed not to exceed the threshold.; therapeutic system that is based on the interaction between the patient's back or painful area and a support surface, composed of small latex cones with various dimensions (height: 3-8 cm; base diameter: 2-4 cm) and elasticities. The inferior bases of these cones are applied to a rigid wood surface using elastic strips.; The control group did brief educational sessions.
Other intervention name(s): Rehabilitation Group Exercises; Perceptual surfaces
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Postural exercise; Back pain; Tender points; Fibromyalgia; Perceptive rehabilitation
Safety and Efficacy of MP-214 in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objective of this study is to evaluate the efficacy, safety, and tolerability of MP-214
      relative to placebo in patients with acute exacerbation of schizophrenia.
    


Intervention name(s): MP-214 3mg; MP-214 6mg; MP-214 9mg; Risperidone 4mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.; Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.; Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.; Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.; Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Antipsychotic Agents; Acute Schizophrenia; Mental Disorder; Psychotropic Drugs; Dopamine Agents; Risperidone; Central Nervous System Agents
CALERIE (Washington University): Comprehensive Assessment of Long-term Effects of Reducing Intake of Energy
Condition: Aging
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is one of three CALERIE trials that test the hypothesis that a reduced calorie,
      nutritionally sound diet increases the length of life and prevents some age-related chronic
      diseases such as cancer, diabetes, and cardiovascular disease. The three sites that are
      participating in the CALERIE trial represent a diversity of subject populations and
      interventional strategies.
    

Detailed description: 
      Animal studies suggest that caloric restriction (CR), or consuming fewer calories, increases
      life span, and also protects against some aging-related disease processes such as
      artherosclerosis and type II diabetes. However, it appears that simply burning more calories
      through physical activity does not increase life span by itself. It is not known how CR
      affects humans, but based on this evidence it appears that the reduced total intake and
      metabolism of food is the main factor, rather than increased exercise alone.

      To test this, volunteers will be placed on a program of either 20% caloric restriction or 20%
      increase of energy expenditure by exercise, or in a control group to be instructed in healthy
      living. All will be evaluated on a number of potential markers of aging, on body composition,
      and on risk factors for artherosclerosis and diabetes.

      Participation in the study will last for 12 months. The Diet group will receive individual
      instruction from a registered dietician. The Exercise group will be given an individualized
      exercise program created by a personal trainer. The Healthy Lifestyle group will be given
      information on how to make healthier choices; both diet and activity will be discussed. All
      participants will be measured every two weeks, and will keep daily food and activity logs.
      All will be seen by a physician and will have lab tests done before beginning the study, at 1
      month, and then 3 month intervals.
    

Intervention name(s): Caloric Restriction (CR); Exercise
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Diet; Caloric Restriction; Exercise; Energy Metabolism; Primary Aging; Secondary Aging
A Study of Apatinib in Non-triple-negative Metastatic Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The hypothesis of this clinical research study is to discover if the study drug apatinib can
      shrink or slow the growth of pretreated non-triple-negative metastatic breast cancer.
    

Detailed description: 
      Apatinib is a tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor
      (VEGFR), and its anti-angiogenesis effect has been viewed in preclinical tests. The
      investigators' phase I study has shown that the drug's toxicity is manageable and the maximum
      tolerable daily dose is 850 mg. The hypothesis of this clinical research study is to discover
      if the study drug apatinib can shrink or slow the growth of non-triple-negative breast
      cancer. The safety of apatinib will also be studied. Patients physical state, symptoms,
      changes in the size of the tumor, and laboratory findings obtained while on-study will help
      the research team decide if apatinib is safe and effective in pretreated non-triple-negative
      metastatic breast cancer patients.
    

Intervention name(s): Apatinib
Intervention type(s): Drug
Intervention description(s): The starting dose of apatinib will be 500mg/d. Two dose reductions will be allowed to 375 and then 250 mg/d.
Intervention MeSH terms: Apatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic breast cancer; Apatinib; non-triple-negative
Temperature Evaluation by MRI Thermometry During Cervical Cooling
Condition: Healthy
Study type: Interventional

Summary: 
      The American Heart Association (AHA) recommends cooling (inducing mild hypothermia) patients
      who were resuscitated following cardiac arrest but who remained comatose. Induced mild
      hypothermia is now the standard of care for post-resuscitation patients in the intensive care
      unit (ICU) setting. The use of cooling has recently moved to pre-hospital and emergency
      department (ED) application as more current studies show that early initiation of cooling
      significantly improves neurologic outcomes and survival rates instead of waiting until the
      patient arrives in the ICU to initiate cooling. In the pre-hospital setting chilled saline
      (4°C) and packing the body in ice have been the primary methods to initiate induced mild
      hypothermia The Excel Cryo Cooling System is a non-invasive cervical collar (C-collar) that
      provides cooling to the carotid arteries, the main blood supply to the brain, and allows for
      the rapid initiation of selective cerebral cooling. The investigators are planning to use
      MRI-thermometry to see how quickly the Excel Cryo Cooling Collar can drop brain temperature
      when applied by itself.

      Healthy volunteers will be used for this study to provide important temperature data on the
      effectiveness of the Excel Cryo Cooling System. The investigators will be able to use the
      data from this project to further the current clinical research in induced mild hypothermia
      after cardiac arrest.
    


Intervention name(s): Cooling pack activated Excel Cryo Cooling Collar
Intervention type(s): Device
Intervention description(s): Cooling pack will be activated before insertion into collar. The first cooling pack will be replaced 20 minutes later with a new, activated cooling pack.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: induced mild hypothermia; cervical cooling collar; mri brain thermometry; MRI thermometry; rate-of-cooling; Excel Cryo Cooling Collar
Helichrysum Italicum Infusion Ingestion in Humans
Condition: Energy Expenditure; Substrate Oxidation; Blood Pressure
Study type: Interventional

Summary: 
      The study evaluates the acute effects of Helichrysum italicum on resting energy expenditure
      and substrate oxidation in humans. The resting energy expenditure and substrate oxidation
      will be measured by indirect calorimetry at baseline and after ingestion of either
      Helichrysum italicum infusion or hot water.
    

Detailed description: 
      Bioactive compounds found in medicinal plants and plant extracts, such as polyphenols,
      represent the oldest and most widely used form of alternative or complementary treatments for
      the prevention and management of obesity. Their consumption is currently increasing in the
      population due to the high cost, potential adverse effects and limited benefits of currently
      available pharmaceutical drugs. Helichrysum italicum is a mediterranean plant with promising
      nutraceutical activities. The plant is known as a rich source of biologically active
      compounds such as polyphenolic antioxidants, which are recognized in the prevention of
      various non-communicable chronic diseases. However, most of its traditionally claimed uses
      have not yet been scientifically proven.

      The proposed study will investigate the acute effect of Helichrysum italicum infusion on
      resting energy expenditure, substrate oxidation, respiratory quotient and blood pressure in a
      pilot study of 11 male adults. It will be designed as a crossover study. Half of the
      participants will consume the Helichrysum italicum infusion and the other half will consume
      hot water. After seven days of washout period the participants will consume the alternate
      beverage.
    

Intervention name(s): Helichrysum italicum infusion; Hot water
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Active beverage or control beverage consumption after overnight fasting and calorimetry measurement on a single subject. After seven days washout period follows the consumption of the alternate beverage and measurements.; Active beverage or control beverage consumption after overnight fasting and calorimetry measurement on a single subject. After seven days washout period follows the consumption of the alternate beverage and measurements.
Other intervention name(s): Active beverage; Control beverage
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bioactive compounds; functional beverages; metabolism; helath