bioihbjkbjnl/mcl2 huggingface dataset:
Pentosan Polysulfate Sodium and Meclofenamic Acid as Treatments in Patients With Psychotic Disorders
Condition: Psychotic Disorders; Schizophrenia; Schizoaffective Disorder; Bipolar Disorder
MeSH terms: Schizophrenia; Bipolar Disorder; Mental Disorders; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study evaluates the feasibility of administering meclofenamic acid or pentosan
      polysulfate sodium as an adjunctive treatment to patients diagnosed with a psychotic
      disorder. Half of participants will receive meclofenamic acid, while the other half will
      receive polysulfate sodium.
    

Detailed description: 
      Chronic, low-grade brain inflammation is involved in the development of schizophrenia and
      other psychotic disorders. Medications with anti-inflammatory properties, like meclofenamic
      acid and pentosan polysulfate may help to reduce brain inflammation and serve as a treatment
      of psychotic disorders.
    

Intervention name(s): Meclofenamic acid; Pentosan polysulfate sodium
Intervention type(s): Drug; Drug
Other intervention name(s): Meclomen; Elmiron; Hemoclar; Fibrase; Anarthron
Intervention MeSH terms: Meclofenamic Acid; Pentosan Sulfuric Polyester
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psychotic; Schizophrenia; Schizoaffective; Bipolar
Bioequivalence Study of Torrent Pharmaceutical Ltd.'s Rabeprazole Sodium Delayed Release Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective:

      Primary objective of the present study was to compare the single dose bioavailability of
      Torrent's Rabeprazole Sodium Delayed Release Tablets 20 mg and Aciphex® Delayed Release
      Tablets 20 mg (Reference, Eisai Inc., USA). Dosing periods were separated by a washout period
      during fed study.

      Study Design:

      Open-Label, Randomised, two Period, two treatment, Crossover, Single-Dose Bioequivalence
      Study
    


Intervention name(s): Rabeprazole sodium 20 mg Delayed Release tablet
Intervention type(s): Drug
Intervention MeSH terms: Rabeprazole
Study Evaluating Effects of Levonorgestrel and Ethinyl Estradiol on Ovulation
Condition: Ovulation
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the ability of a monophasic oral contraceptives ("OC") regimen of Levonorgestrel
      ("LNG") 90 mg and Ethinyl Estradiol ("EE") 20 mg to inhibit ovulation during 84 days of
      continuous therapy.
    


Intervention name(s): Levonorgestrel; Ethinyl Estradiol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Levonorgestrel; Ethinyl Estradiol; Estradiol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ovulation; Oral Contraceptive
Coenzyme Q10 as a Symptomatic Treatment in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to evaluate the symptomatic effects of Coenzyme Q10 nanodispersed
      solution in middle-stage Parkinson's disease (PD) patients (Hoehn&Yahr II to III). The
      treatment phase includes three months period of 300 mg Coenzyme Q10 per day or placebo.

      The primary outcome measure was the combined Unified Parkinson's Disease Rating Scale (UPDRS)
      Part II and III.

      The hypothesis of this study was that Coenzyme Q10 improves the energy status of the diseased
      dopaminergic neuronal cell type and thus producing more dopamine leading to an improvement of
      parkinsonian symptoms in PD patients.
    

Detailed description: 
      This study was designed to evaluate the symptomatic effects of Coenzyme Q10 nanodispersed
      solution in middle-stage non-fluctuating Parkinson's disease (PD) patients (Hoehn&Yahr II to
      III). The treatment phase includes three months period of 300 mg Coenzyme Q10 per day or
      placebo.

      The design of the study was a prospective, randomized, multicenter, double-blind
      placebo-controlled protocol. The intervention includes 100 mg Coenzyme Q10 nanodispersion
      (Nanoquinon solution) tid or matched placebo for three months.

      Participating study centers include Neurological University Outpatient Clinics and
      Neurological Departments of Community-based Hospitals experienced with PD patients.

      The primary outcome measure was the combined Unified Parkinson's Disease Rating Scale (UPDRS)
      Part II and III.

      The hypothesis of this study was that Coenzyme Q10 improves the energy status of the diseased
      dopaminergic neuronal cell type and thus producing more dopamine leading to an improvement of
      parkinsonian symptoms in PD patients.

      Main inclusion criteria:

        -  Parkinson's disease according to the UK Brain Bank criteria

        -  Hoehn & Yahr stadium II until III

        -  Age 40 to 75 years

        -  UPDRS Part III > 15 points

        -  No motor fluctuations or dyskinesias

        -  Stable medication for 4 weeks prior to inclusion

      Main exclusion criteria:

        -  Atypical parkinsonian syndromes

        -  Dyskinesias or motor fluctuations

        -  Coenzyme Q10 treatment in the past

        -  Pregnancy
    

Intervention name(s): Coenzyme Q10 Nanodispersion (Nanoquinone); Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ubiquinone; Coenzyme Q10
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Parkinson's disease; Coenzyme Q10; Treatment; Neuroprotection
Epigenetics and Metabolic Disorders in Men With the Klinefelter Syndrome
Condition: Klinefelter Syndrome, Hypogonadism
MeSH terms: Klinefelter Syndrome; Hypogonadism; Syndrome
Study type: Observational

Summary: 
      This study will elucidate how the parental origin of the X-chromosome influences health
      status as well as metabolic fate in Klinefelter patients. Epigenetics and
      transcriptome-research will be directly linked to the metabolic and inflammatory pattern of
      actual patients to improve care for them. The Klinefelter Syndrome is one of the most common
      genetic disorders in men. The patients have one supernumerary X-chromosome, which is partly
      active and disturbs a normal male development. Testosterone deficiency in form of primary
      hypogonadism is a common feature in these men. Such a condition promotes clinically relevant
      metabolic patterns related to a pro-inflammatory status and diabetes mellitus type 2 (insulin
      resis-tance), cardiovascular disease as well as infertility. However, the variety of
      pathologies is pro-nounced between patients and low testosterone concentrations cannot fully
      explain the wide scope of pathologies in these men. Some patients become clinically obvious
      during puberty and adoles-cence, some in their thirties or later and all exhibit a huge
      variation in phenotype. Switching on and off of specific genes on the X-chromosome is
      differential, depending on the origin either from the maternal or paternal side. Hence, an
      influence on the clinical picture is hypothesised. Thus, key targets are clarification of the
      parental origin of the supernumerary X chromosome and elucidation of methylation and
      expression profile of pivotal X-chromosomal genes. These will be related to clinically
      relevant metabolic and inflammatory patterns as well as fertility to identify individual
      risks as well as treatment strategies for Klinefelter patients.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients, their parents, male controls, female controls
      
Biospecimen description: 
      Blood, Testicular Tissue, Mouth Epithelium
    
Keywords: Hypogonadism, Klinefelter Syndrome, Cardiovascular Risk, Epigenetics, Methylation of Genes; Cardiovascular risk factors; Gonadal status; Gene expression; Methylation
Metabolically Healthy Obesity: Correlations Between BMI and Metabolic Syndrome Biomarkers
Condition: Obesity
MeSH terms: Obesity; Metabolic Syndrome; Obesity, Metabolically Benign
Study type: Observational

Summary: 
      The study team's research fills the gap in the obesity literature where BMI with a cut point
      of 35 is frequently used to show the association between BMI and metabolic syndrome
      biomarkers. The study team was unable to locate any papers that showed the association
      between metabolic syndrome biomarkers and BMI from 35 to 69.9, and especially graphically as
      this clinical team has presented.
    

Detailed description: 
      A positive association between BMI and metabolic health risk is often presented graphically
      as a J-shaped curve with BMI on the x-axis and the biomarker of interest on the y-axis.
      However, BMI is frequently presented in the literature with a cut point of 35 on the x-axis,
      leading to the assumption that the steep association continues beyond a BMI of 35. This
      presentation does not capture the metabolically healthy individual with obesity.

      In the population of men and women with class II and II obesity who the clinical team
      studied, it was examined that the association between BMI as a continuous variable from 35 to
      69.9 and metabolic syndrome biomarkers (total-, low density, and high density cholesterol,
      triglycerides, systolic and diastolic blood pressure, fasting blood glucose, and glycosylated
      hemoglobin), the study team found no evidence for a positive correlation between BMI and TC,
      LDL-C, TG, and FBG. And while the study team did find positive and significant correlations
      between BMI and HDL-C, SBP, DBP, and HgbA1C, the effect sizes were small and arguably
      clinically insignificant.

      The study team's research fills the gap in the obesity literature where BMI with a cut point
      of 35 is frequently used to show the association between BMI and metabolic syndrome
      biomarkers. The clinical team was unable to locate any papers that showed the association
      between metabolic syndrome biomarkers and BMI from 35 to 69.9, and especially graphically as
      this clinical team has presented.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        BMI 35- 69.9 Men and Women over age 25
      
Keywords: BMI; Obesity
Acceptability and Tolerance Study of New Oral Nutritional Supplement PRAGUE
Condition: Malnutrition
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      Tolerance and Acceptability of new oral nutritional supplement - AYMES PRAGUE
    

Detailed description: 
      To evaluate tolerance and acceptability of AYMES PRAGUE in patients requiring supplementary
      oral nutritional support compared with currently available alternatives, measuring outcomes
      of GI effects, Compliance, product preference,convenience etc.

      To obtain data to support an ACBS submissions for AYMES PRAGUE (to allow for prescription in
      the community at NHS expense).
    

Intervention name(s): AYMES PRAGUE
Intervention type(s): Dietary Supplement
Intervention description(s): AYMES PRAGUE is a ready to drink, high energy, low volume oral nutritional supplement drink. It provides 300 kcal and 12g protein per 125ml serving. It is a Food for Special Medical Purposes (FSMP) and must therefore be used under medical supervision. It is not designed as a sole source of nutrition.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Primary Immunodeficiencies in Costa Rican Adults
Condition: Primary Immune Deficiency in Adults
MeSH terms: Primary Immunodeficiency Diseases; Immunologic Deficiency Syndromes
Study type: Observational [Patient Registry]

Summary: 
      Primary immunodeficiencies represent a underdiagnosed group of rare diseases which if
      diagnosed well and in time can be treated in an efficient manner and prevent complications
      that may affect the quality of patients life in an severe manner. Neither in Costa Rica nor
      in Central America studies or national registries regarding the prevalence and
      characterization of primary immunodeficiencies in adult patients exist up to now. This study
      reflects for the first time the epidemiologic situation of primary immunodeficiencies in a
      Central American country, characterizing adult patients diagnosed with primary and idiopathic
      immune disorders treated in two specialized immunodeficiency clinics in Costa Rica.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        All cases of primary immunodeficiency and idiopathic defects of immunity detected in the
        primary immunodeficiency clinics of the Hospitals Mexico and Dr. Rafael Ángel Calderón
        Guardia between November 2017 and May 2018.
Femoral or Sciatic Nerve Block to Provide Analgesia After Proximal Tibial Osteotomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Proximal tibial osteotomy is associated with moderate to severe postoperative pain. The
      proximal part of the tibia is innervated by branches from the femoral nerve anteriorly and
      the sciatic nerve posteriorly. Little is known on the type of peripheral nerve block to
      perform so that optimal postoperative analgesia is provided with minimum impact on the motor
      function. This randomised controlled double-blinded trial tested the hypothesis that a
      femoral nerve block provides superior analgesia than a sciatic nerve block after proximal
      tibial osteotomy.
    


Intervention name(s): Femoral nerve block with ropivacaine 0.5%, 20 ml; Sciatic nerve block with ropivacaine 0.5%, 20 ml
Intervention type(s): Procedure; Procedure
Intervention description(s): Femoral nerve block under ultrasound guidance with ropivacaine 0.5%, 20 ml; Sciatic nerve block under ultrasound guidance with ropivacaine 0.5%, 20 ml
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups: femoral nerve block or sciatic nerve block with ropivacaine
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Is Electrolyte Maintenance Solution Required in Low-Risk Children With Gastroenteritis?
Condition: Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to clarify the current standard of care by determining if
      Electrolyte Maintenance Solution (EMS) is truly the optimal fluid to be used in low-risk
      children who present to an Emergency Department (ED) with < 72 hours of vomiting or diarrhea.
    

Detailed description: 
      Gastroenteritis remains a major cause of morbidity amongst Canadian children. The primary
      treatment focus revolves around the use of Oral Rehydration Therapy (ORT) to treat
      dehydration and replace intravascular volume. Since diarrheal disease in Canadian children
      usually results in mild dehydration and minimal sodium losses, the use of low sodium
      Electrolyte Maintenance Solutions (EMS) has become the standard of care. However, given that
      North American children infrequently develop severe dehydration, it is unclear if the routine
      use of EMS is justified. When pediatricians directly dispense EMS, 16 children need to be
      treated to prevent 1 unscheduled office visit, however the upper bound of the 95% confidence
      interval is an astounding 508 patients. In addition, EMS is considered by some to be
      prohibitively expensive, with 15% of pediatricians believing it to be too expensive for their
      patients to purchase. An additional 40% report that taste is a major barrier to consumption.
      As a result, oral fluid replenishment is often underutilized and IV rehydration employed
      instead. Our goal is to provide evidence to guide the selection of the optimal ORT fluids in
      low-risk children, thus increasing its use, enhancing its success, and reducing the reliance
      on intravenous rehydration. We hypothesize that the strict adherence to EMS use in low-risk
      children may actually be counterproductive by resulting in reduced fluid intake and
      potentially increasing the use of intravenous rehydration.
    

Intervention name(s): ½ strength apple juice; Pediatric Electrolyte
Intervention type(s): Other; Other
Intervention description(s): For each episode of diarrhea 10 ml/kg of fluid will be given and for each episode of vomiting 2 ml/kg will be given. If the child does not like the solution another fluid can be used.; For each episode of diarrhea 10 ml/kg of fluid will be given and for each episode of vomiting 2 ml/kg will be given. If the child does not like the solution another electrolyte maintenance fluid can be used. Fluids containing non-physiological concentrations of glucose and electrolytes (carbonated drinks, sweetened fruit juices, water) will be discouraged.
Other intervention name(s): Oral Electrolyte Maintenance Solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pediatrics; Gastroenteritis; Oral Rehydration; Electrolyte Maintenance Solution
A Drug Interaction Study of SPD503 and Vyvanse Administered Alone and In Combination in Normal Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Drug-drug interaction study; to examine the pharmacokinetics of SPD503 and VYVANSE
      (lisdexamfetamine dimesylate) when given alone, and in combination.
    


Intervention name(s): SPD503; VYVANSE; SPD503 and VYVANSE
Intervention type(s): Drug; Drug; Drug
Intervention description(s): SPD503 extended-release 4mg orally administered tablets. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken.; VYVANSE 50mg orally administered capsules. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken.; SPD503 4mg tablets + VYVANSE 50mg capsules orally administered together. There are 3 dosing periods in the study. Subjects will receive one dosing regimen (arm) as a single oral dose on the first day of each dosing period. The order in which the subjects receive each arm (regimen) is randomly assigned. There is a 7-day break between each dosing period in which no medication is taken.
Other intervention name(s): guanfacine hydrochloride; lisdexamfatamine dimesylate (LDX)
Intervention MeSH terms: Guanfacine; Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Normal, healthy volunteers (for this Phase 1 study)
MENstrual Symptom Tracking to Understand and Assess (Women) Living With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Observational

Summary: 
      Cystic fibrosis (CF) affects men and women equally, but after the onset of puberty, women
      with CF have a lower life expectancy than men with CF. Despite these known differences, the
      link between CF symptom trends and the menstrual cycle remains critically understudied. To
      address this gap, this study will investigate changes in CF-specific symptoms among women
      with CF to evaluate whether and how they correlate with their menstrual cycle. Specifically,
      the investigators hope to examine whether CF-related symptoms change throughout the menstrual
      cycle, what the impact of those symptoms is on quality of life, and how feasible it is to use
      a period tracking app to track CF-related symptoms throughout the menstrual cycle.
      Investigators are asking women ages 18-45 with CF, who have regular menstrual cycles, to
      participate. Study procedures, including online surveys, period tracking, and interview, will
      take approximately 3 months.
    

Detailed description: 
      To better understand the connection between cyclically driven hormone fluctuations and
      CF-related symptoms, the investigators propose an explanatory, sequential mixed methods study
      in which 80 menstruating women with CF will be asked to track their daily CF-related symptoms
      for three consecutive cycles. From this cohort, the investigators will ask up to 30 women
      with CF to participate in one semi-structured interview to gather information about the
      impact of cyclical CF symptoms upon women's daily lives and any strategies they use to manage
      them. This study uses innovative technology to track CF-specific symptoms with a smartphone
      app. The investigators' hypothesis is that subjective changes in clinical CF symptoms,
      including pulmonary and sinus (primary outcome), rheumatic, and gastrointestinal (secondary
      outcomes), will map onto the phases of the menstrual cycle and will be cyclical in nature;
      women will report alternative ways in which they manage their cyclical CF symptoms; and the
      period tracker app will be easy for women to use.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Regularly menstruating women with Cystic Fibrosis
      
Keywords: Cystic Fibrosis; Menstrual Cycle
Levetiracetam in the Management of Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional

Summary: 
      A 6-week outpatient, double-blind, placebo-controlled, add-on trial to investigate the
      effects of levetiracetam on depressive symptoms in bipolar depressed patients.
    


Intervention name(s): Levetiracetam; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Flexible dose up to 2500mg per day, for 6 weeks.; Flexible dose up to 2500mg per day, for 6 weeks.
Other intervention name(s): Keppra
Intervention MeSH terms: Levetiracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Keppra; Levetiracetam; Anticonvulsant; Depression; Bipolar Disorder; Affective Disorders; Mood Disorders; Double Blind; Acute Antidepressant Effects