bioihbjkbjnl/mcl2 huggingface dataset:
Molecular and Clinical Effects of Green Tea and Fermented Papaya Preparation on Diabetes and Cardiovascular Diseases
Condition: Assess the Effect of Green Tea on Diabetes; Assess the Effect of Fermented Papaya Pretration on Diabetes; Effects of Green Tea and FPP on C-reactive Proteins; Effects of Green Tea and FPP of Lipid Profiles in Diabetes; Effect of Green Tea and FPP on Atheroma Formation
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus; Plaque, Atherosclerotic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Type 2 diabetes is common in ethnic and, minority groups in developing and developed
      countries such as Africans, African Americans, Asians, Native Americans, Hispano-Latinos and
      Alaskan indians. A randomized controlled study to assess the efficacy of fermented papaya
      preparation and green tea infusates in latent diabetes (individuals newly diagnosed as
      diabetics) is proposed. Glycation products from excess glucose autooxidation can chemically
      modify DNA causing mutations and cause complex DNA rearrangements. Advanced glycation
      end-products which play a role as proinflammatory mediators in gestational diabetes can
      accelerate vascular occlusion by quenching the vasodilating agent nitric oxide. Interaction
      with high-affinity receptors located on monocytes and macrophages can enhance the production
      of free radicals and reactive oxygen/nitrogen species, the secretion of tumor necrosis
      factor-α, interleukin-1 and insulin-like growth factor I which can proliferate endothelial,
      mesangial and smooth muscle cells and hence contribute significantly to the pathogenesis of
      cardiovascular complications. The clinical markers include C-reactive proteins (inflammation
      indicators), protein C (markers of reno vascular injury), uric acid, natriuretic peptides,
      and the integrity of isolated adipocytes, glucose levels, lipid indices (triglycerides, total
      cholesterol, VLDL, HDL and LDL). Given that decreased functional activity of activated
      protein C affects the permeability of the glomerular capillary wall and enhances apoptosis of
      glomerular endothelial cells and adipodocytes, this has relevance to the pathophysiology of
      diabetic nephropathy. A second phase of the study is expected to commence after the first 16
      weeks in order to assess the ability of the dietary factors to modulate atheroma formation
      and the integrity of drug therapy (upon commencement of treatment)on the prognosis of
      diabetes. This will be expected to last up to 3 years.
    


Intervention name(s): Green tea; FPP
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 9 gram per day; 2 sachets twice daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Green Tea; Fermented papaya preparation; Diabetes; Cardiovascular diseases; Atherosclerotic plaques; Glucose; Dietary supplements and functional foods
The Effect of Adenosine on Cranial Hemodynamic, Headache and Migraine Induction Properties.
Condition: Headache, Migraine
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

Summary: 
      Adenosine is a nucleoside that plays a role in both vascular and nociceptive systems, and it
      has been proposed that adenosine may cause headache in particularly sensitive subjects.

      Thus, considerable evidence implied that adenosine plays a role in migraine pathophysiology,
      it is still unknown if intravenous adenosine infusion provokes migraine attacks in healthy
      subject or in migraine patients. Furthermore, adenosine's effects on the cerebral hemodynamic
      remains unknown.

      This study aims to clarify a possible coherence between adenosine and headache/migraine. In
      general, the study will contribute to a greater understanding of migraine pathogenesis and
      possibly lead to development of specific migraine treatment.
    


Intervention name(s): Adenosine; Saline
Intervention type(s): Drug; Drug
Intervention description(s): To investigate the role of adenosine on cerebral hemodynamic and headache in healthy volunteers and migraine patients; To investigate the role of saline on cerebral hemodynamic and headache in healthy volunteers and migraine patients
Intervention MeSH terms: Adenosine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
An Open-Label Study of Emtricitabine in Combination With Other Antiretroviral Agents in HIV Infected Pediatric Subjects
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      To obtain safety and efficacy data for antiretroviral regimens containing emtricitabine in
      HIV-1 infected pediatric subjects. To determine emtricitabine concentrations in HIV-1
      infected pediatric subjects and, if necessary, to refine the dose of emtricitabine to achieve
      concentrations comparable to those in adults given 200 mg emtricitabine once-daily.
    


Intervention name(s): Emtricitabine; Emtricitabine
Intervention type(s): Drug; Drug
Intervention description(s): emtricitabine (6mg/kg QD; max 200 mg QD) plus stavudine 1 mg/kg BID (if <30kg)plus lopinavir/ritonavir (12/3 mg/kg BID if >=7 to <15kg; 10/2.5 mg/kg BID if >=15 to <=40 kg); emtricitabine (6 mg/kg QD, up to 200 mg QD capsule formulation or up to 240 mg QD using the oral solution) plus didanosine (240 mg/m2 up to 400 mg QD) plus efavirenz (up to 600 mg QD capsule formulation or up to 720 mg QD using the oral solution).
Other intervention name(s): FTC; FTC
Intervention MeSH terms: Emtricitabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Emtricitabine; Pediatric; HIV-1; Treatment of HIV-1
A Study to Evaluate the Safety, Tolerability and Immunogenicity of Tau Targeted Vaccines in Participants With Early Alzheimer's Disease
Condition: Alzheimer's Disease; Cognitive Impairment; Tauopathies; Mild Cognitive Impairment; Dementia; Brain Diseases; Central Nervous System Diseases
MeSH terms: Alzheimer Disease; Dementia; Nervous System Diseases; Brain Diseases; Central Nervous System Diseases; Tauopathies; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is a multicenter, double blind, randomized, placebo-controlled study to evaluate
      the safety, tolerability and immunogenicity of different doses, regimens and combinations of
      Tau targeted vaccines in participants with early Alzheimer's Disease.
    


Intervention name(s): ACI-35.030; ACI-35.030; ACI-35.030; Placebo; JACI-35.054; JACI-35.054
Intervention type(s): Biological; Biological; Biological; Other; Biological; Biological
Intervention description(s): Administration of a Low dose of ACI-35.030; Administration of a Medium dose of ACI-35.030; Administration of a High dose of ACI-35.030; Administration of Placebo; Administration of a Low dose of JACI-35.054; Administration of a Medium dose of JACI-35.054
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's Disease; Cognitive Impairment; Tauopathies; Mild Cognitive Impairment; Dementia; Brain Diseases; Central Nervous System Diseases
Virtual Acoustic Localization Experiment
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      The present study has the evaluation of a test to measure the localization performance goal .
      It is about the perception of danger audio signals in everyday listening environments nearby
      which are reproduced in controlled laboratory conditions. In addition, a dereverberation
      algorithm regarding speech intelligibility and localization ability is evaluated . The
      research hypothesis is that the dereverberation of the audio signals can improve speech
      intelligibility for both normal hearing and hearing-impaired persons. In addition, the
      binaural dereverberation algorithm should not affect the localization ability in everyday
      situations.
    


Intervention name(s): Oldenburger sentence test, localization test
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
The Effect of Hawthorn on Lipoprotein Cholesterol Ratio in Schizophrenics With Antipsychotics
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Importance: The problems of side effects of metabolic disturbances in schizophrenic patients
      have been of worldwide concern for some time. Patients with dyslipidemia have an increased
      risk of cardiovascular diseases. A Chinese herb, Hawthorn, is widely used for the treatment
      of dyslipidemia.

      Objective: Therefore, this study aimed to investigate the effect of Hawthorn on lipid profile
      levels in schizophrenic patients treated with antipsychotics.

      Design, Setting, and Participants: A longitudinal case-control study was used in a general
      hospital in Taiwan. A total of 59 schizophrenics treated with antipsychotics, and 76 healthy
      adult subjects, who were all hospital workers, were enrolled in this study.

      Main outcomes and measures: All participants received Hawthorn at a dose of 3 gm/day for six
      months.
    

Detailed description: 
      The problem of metabolic disturbances in schizophrenic patients who take antipsychotics has
      always been a cause for global concern and discussion. Although Hawthorn is widely used in
      the treatment of heart problems and the lowering of blood lipid levels, it is unknown whether
      Hawthorn has an effect in schizophrenic patients treated with antipsychotics. Hence, there
      are several areas of interest in the present study: 1) the effect of Hawthorn on lipid
      profile levels in schizophrenic patients treated with antipsychotics; 2) a comparison of
      lipid profile levels between schizophrenic patients and healthy adults; 3) the contributing
      factors that relate to changes in lipid profile levels in patients who take Hawthorn.
    

Intervention name(s): Hawthorn; SGAs
Intervention type(s): Other; Drug
Intervention description(s): Hawthorn tablet; SGAs tablet
Other intervention name(s): second-generation antipsychotics
Intervention MeSH terms: Antipsychotic Agents
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: case control study
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Hawthorn; TG/HDL ratio; dyslipidemia; schizophrenia; antipsychotics
Hydroxychloroquine Administration for Reduction of Pexophagy
Condition: Zellweger Syndrome; Peroxisome Biogenesis Disorders
MeSH terms: Zellweger Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      A series of N-of-1, crossover, randomized, placebo-controlled, double-blinded trial.
      Hydroxychloroquine (HCQ) and a crossover to placebo (order is randomized and blinded) will be
      administered in liquid suspension for 84 days (12 weeks) each with an 84 day washout in
      between. We hypothesize that HCQ will reduce peroxisomal turnover, which will arrest ongoing
      injury in PBDs caused by PEX1, PEX6 or PEX26.
    

Detailed description: 
      HARP is a phase II/III, double-blind, placebo-controlled, randomized, crossover series N-of-1
      study of the effect of hydroxychloroquine (HCQ) in patients with peroxisomal biogenesis
      disorders (PBD-ZSD). Patients eligible for the study must have a laboratory diagnosis of
      PEX1, PEX6 or PEX26 dependent PBD-ZSD from a CLIA or SCC-certified clinical laboratory, a
      history of abnormal VLCFA levels, and must be at least 84 days from their last HCQ dose.
      Patients will be excluded for known sensitivity to HCQ, known glucose-6-phosphate
      dehydrogenase deficiency, if they have an expected survival of less than 9 months or if they
      are participating in another interventional clinical trial.

      HCQ will be administered at a dose of 4mg/kg/day divided into two doses, as a liquid
      suspension that can be given orally or through nasogastric or gastric tube. Within the study,
      HCQ or placebo will be given for 84 days, followed by a washout period of 84 days followed by
      an 84 day crossover to the alternative therapy to assess the effect the study measures.

      Study measures will be completed at four intervals (initiation, end of period 1, start of
      period 2, end of trial). Ophthalmological monitoring of patients has three components,
      electroretinogram (ERG), visual acuity testing and optical coherence tomography (OCT). Plasma
      levels of very long-chain fatty acids (VLCFA), plasmalogen and phytanic acid will be
      assessed. Parents will also be administered The Pediatric Inventory for Parents (PIP), a
      questionnaire that was developed to evaluate the stress associated with parenting a seriously
      ill child, at the end of period 1 and period 2.
    

Intervention name(s): Hydroxychloroquine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Hydroxychloroquine: 4mg/kg/day, divided bid.; Liquid suspension compounded to mimic the active hydroxycholoquine interventional agent.
Other intervention name(s): Apo-Hydroxyquine; Plaquenil
Intervention MeSH terms: Hydroxychloroquine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A randomized, blinded, placebo controlled, crossover N of 1 trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PBD, Zellweger spectrum, PBD-ZSD
Fatigue Levels in Fibromyalgia Syndrome
Condition: Fatigue; Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Fatigue
Study type: Observational

Summary: 
      Ninety (90) woman patients diagnosed with fibromyalgia according to the American College of
      Rheumatology 2010 diagnostic criteria and 90 healthy volunteers were included. The
      Fibromyalgia Impact Questionnaire (FIQ) is used to assess the patient's functionality and
      determine the severity of the disease. The Fatigue Severity Scale (FSS) assessed the level
      and severity of fatigue. The short form of the International Physical Activity Questionnaire
      (IPAQ-SF) used to asess physical activity levels.The kinesiophobia level was assessed by
      using the Tampa Scale for Kinesiophobia.
    

Detailed description: 
      Our study consists of 180 female participants aged between 18 and 65 years who applied to the
      physical therapy and rehabilitation outpatient clinic between April 2021 and August 2021.
      This case-control study was conducted according to the Declaration of Helsinki. Participants
      gave written voluntary consent and enrolled in this case-control study.

      Ninety (90) woman patients diagnosed with fibromyalgia according to the American College of
      Rheumatology 2010 diagnostic criteria and 90 healthy volunteers were included. Fibromyalgia
      Impact Questionnaire, Tampa Kinesiophobia Scale, Fatigue Severity Scale and The short form of
      İnternational Physical Activity Questionnaire (IPAQ-SF) were completed. All scales were
      filled in face to face for the participants. In addition, demographic data (age, gender,
      height, weight, marital status, education level) and duration of fibromyalgia diagnosis were
      recorded.

      Exclusion criteria for both groups; The presence of health problems that affect the level of
      physical activity ( Cardiac or pulmonary insufficiency, limb amputation, recent surgery
      history) and cognitive impairment that prevents answer questions
    

Intervention name(s): STUDY
Intervention type(s): Other
Intervention description(s): Fibromyalgia Patient
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Our study consists of 180 female participants aged between 18 and 65 years who applied to
        the physical therapy and rehabilitation outpatient clinic between April 2021 and August
        2021. This case-control study was conducted according to the Declaration of Helsinki.
        Participants gave written voluntary consent and enrolled in this case-control study.

        Ninety woman patients diagnosed with fibromyalgia according to the American College of
        Rheumatology 2010 diagnostic criteria and 90 healthy volunteers were included
      
Keywords: Fibromyalgia Syndrome; Physical Activity; kinesiophobia
A Study of GW685698X in Healthy Japanese Male Subjects
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double blind, placebo controlled, parallel-group, repeat dose study to
      investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of inhaled dose
      from a novel dry powder device in healthy Japanese male subjects.
    


Intervention name(s): Placebo; GW685698X
Intervention type(s): Drug; Drug
Intervention description(s): comparator; Inhaled steroid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Multicenter Comparative Study of the Activity of the Medial Prefrontal Cortex in Vulnerability to Depression
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder
Study type: Observational

Summary: 
      To examine whether the medial prefrontal cortex displays an increased activity during
      self-referential processing among remitted depressed patients compared to healthy controls
    


Observational model: Case-Control
Sampling method: Non-Probability Sample
Study population: 
        Formerly depressed patients and healthy controls matched for age and sex
      
Keywords: depression
Effects of N-acetylcysteine on Diabetic Foot Oxygenation
Condition: Foot Ulcer, Diabetic
MeSH terms: Diabetic Foot; Foot Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether N-acetylcysteine is effective in the
      treatment or prevention of the foot ulcers in diabetic patients.
    


Intervention name(s): N-acetylcysteine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 600 mg, 1 tablet 3 times a day for 3 months; Placebo
Other intervention name(s): Fluimucil (R) 600 mg, tablets
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage C; grade 0 (Texas University)
Cranberry Juice for the Prevention of Recurrent Urinary Tract Infections
Condition: Urinary Tract Infections
MeSH terms: Infections; Urinary Tract Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will determine whether cranberry juice is effective in reducing recurrent urinary
      tract infections (UTIs) in women who have had a UTI within the past year.
    

Detailed description: 
      UTIs are a common problem among young women, resulting in considerable morbidity and health
      care costs. Increasing resistance to antibiotics is making treatment of these infections even
      more problematic. Therefore, safe and effective nonantimicrobial prevention strategies are
      needed. One approach that appears to be effective is the use of cranberry products. However,
      data on the safety and effectiveness of cranberry products are limited. This study will
      determine whether cranberry juice can reduce UTIs in women.

      Participants will be randomly assigned to receive either cranberry juice or a placebo drink
      daily for 6 months. Study visits will occur every month for the 6-month treatment phase of
      the study. At study entry and at each study visit, urine collection will occur and vaginal
      swabs will be taken. A rectal swab will be taken at study entry and at the Month 2 and 4
      visits. Participants will be asked about medication usage, any side effects they may be
      experiencing, and diet at each study visit. If participants develop a UTI at any time during
      the study, they will be asked to visit the study site within 24 hours.
    

Intervention name(s): Cranberry juice cocktail
Intervention type(s): Drug
Intervention description(s): Participants will consume 4 or 8 ounces of Cranberry Juice Cocktail or Placebo daily for 6 months.
Other intervention name(s): CJC; cranberry
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vaccinium macrocarpon; Cranberry; Complementary Therapies