bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Disorders of Excessive Somnolence; Sleepiness
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the efficacy of BF2.649 over placebo (12 week Double-Blind Phase) and assess the
      long term safety and the efficacy maintenance(9 months Open-Label Extension Phase) of BF2.649
      in the improvement of excessive daytime sleepiness in patients diagnosed with Parkinson's
      Disease.
    

Detailed description: 
      As measured by the change from baseline in the Epworth Scale Scores (ESS) at Week 12 and at
      Week 51, in patients diagnosed with EDS in Parkinson's Disease.
    

Intervention name(s): BF2.649 (pitolisant)
Intervention type(s): Drug
Intervention description(s): 1 capsule of BF2.649 (5mg, 10mg , 20 mg) O.D
Other intervention name(s): Pitolisant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: EDS in Parkinson's Disease
Efficacy/Safety of Rosuvastatin+Ezetimibe in High Risk Patients With Primary Hypercholesterolemia/Mixed Dyslipidemia
Condition: Hypercholesterolemia; Dyslipidemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the non-inferiority between two different FDC
      (fixed-dose combination), measuring LDL-Cholesterol levels, in high risk patients with
      primary hypercholesterolemia or mixed dyslipidemia.
    

Detailed description: 
      The primary efficacy variable was the percentage of LDL-C variation at the end of nine weeks
      of treatment, compared to baseline (pre-randomization), in participants who achieved LDL <100
      mg/dL were considered to have been successfully treated.
    

Intervention name(s): Rosuvastatin 10 mg + Ezetimibe 10 mg and Rosuvastatin 20 mg + Ezetimibe 10 mg, according to clinical evaluation.; Simvastatin 20 mg + Ezetimibe 10 mg and Simvastatin 40 mg + Ezetimibe 10 mg, according to clinical evaluation.
Intervention type(s): Drug; Drug
Intervention description(s): Tables containing: Rosuvastatin 10 mg + Ezetimibe 10 mg and Rosuvastatin 20 mg + Ezetimibe 10 mg, according to clinical evaluation.; Tables containing: Simvastatin 20 mg + Ezetimibe 10 mg and Simvastatin 40 mg + Ezetimibe 10 mg, according to clinical evaluation.
Other intervention name(s): Lance; Vytorin
Intervention MeSH terms: Rosuvastatin Calcium; Simvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypercholesterolemia; Dyslipidemia
Sex-related Differences in the Response to the Muscle Relaxant Drug Mivacurium
Condition: Muscle Relaxation; Sex
Study type: Interventional
Phase: Phase 1

Summary: 
      Muscle relaxants are drugs providing muscle relaxation during surgical treatment. Previous
      studies have shown that males and females respond differently to this kind of drug. Our
      hypothesis is that males are more sensitive to the effect of Mivacurium (a muscle relaxant)
      than females, meaning that males need a lower blood concentration of the drug than females in
      order to obtain a given effect.
    

Detailed description: 
      Muscle relaxants are a type of drug used to provide muscle relaxation during induction of
      anesthesia and surgical treatment. Residual drug effect postoperatively (i.e. residual muscle
      relaxation) occurs frequently and studies have shown that this may be harmful in certain
      groups of patients. Of special concern is residual effect on upper airway and breathing
      muscles. A previous study has shown that males and females respond differently to the effect
      of this kind of drug. It appears that some muscle groups which are important for airway
      protection and breathing are more sensitive to the effect of muscle relaxants in males than
      females. Males may therefore be more susceptible to postoperative lung complications than
      females. In this study we try to determine what causes the observed sex-related difference in
      response to the muscle relaxant Mivacurium. We have previously shown that this sex-related
      difference cannot be explained by different pharmacokinetics (what the body does to the drug)
      in males and females. Our hypothesis is that a pharmacodynamic (what the drug does to the
      body) difference between sexes exists, i.e. that a lower blood concentration of Mivacurium is
      needed in males than females in order to obtain a predefined degree of muscle relaxation in
      certain muscle groups.
    

Intervention name(s): Mivacurium
Intervention type(s): Drug
Intervention description(s): Effect of Mivacurium in males vs females
Other intervention name(s): Mivacron
Intervention MeSH terms: Mivacurium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nondepolarizing neuromuscular blocking drug; Mivacurium; Sensitivity; Sex
ONO-2952 Single-dose PET Study in Healthy Adult Subjects
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the brain TSPO occupancy of ONO-2952 in
      healthy adult subjects after a single dose using [11C]PBR28 as a specific PET ligand for
      TSPO. The secondary objective is to evaluate the relationship between TSPO occupancy and the
      plasma concentration of ONO-2952 and to investigate the safety and tolerability of ONO-2952
      in healthy subjects.
    


Intervention name(s): ONO-2952
Intervention type(s): Drug
Intervention description(s): 1 mg to 200 mg QD at a single descending dose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ONO-2952; Healthy adult subjects; single doe; PET study; Safety; Tolerability
Tolerance & Responsiveness Improvement for Metformin (TRIM)
Condition: Type2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The overall goal is to explore the hypothesis that prebiotic fiber Psyllium will ameliorate
      diarrhea in African American men (AAM) with Type2 Diabetes Mellitus (T2D).
    


Intervention name(s): Psyllium powder; Metformin Extended Release Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): To evaluate whether Psyllium will alleviate diarrhea; Metformin Extended Release Oral Tablet is standard of care for diarrhea in patients taking metformin
Intervention MeSH terms: Metformin; Psyllium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Two Maxillary Expanders in Improving the Transverse Skeletal and Dental Dimensions in Patients With Cleft Lip and Palate
Condition: Cleft Lip and Palate; Maxillary Expansion
MeSH terms: Cleft Lip
Study type: Interventional

Summary: 
      This randomized controlled trial is designed to compare between quadlelix appliance vs hyrax
      expander regrading the their effectiveness in maxillary expansion in patients with cleft.
    


Intervention name(s): Maxillary Expansion
Intervention type(s): Device
Intervention description(s): 2 appliances to expand the maxillary arch
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Trial Comparing Iron Supplementation Versus Routine Iron Intake in Very Low Birth Weight Infants
Condition: Iron Deficiency Anemia
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies; Birth Weight
Study type: Interventional

Summary: 
      In preterm infants with birth weights less than 1500 grams, does iron supplementation with
      2mg/kg/day in addition to routine feeding with routine iron-fortified milk (formula or
      fortified mother's milk), as compared to routine iron fortified milk, increase hematocrit at
      36 weeks adjusted postmenstrual age (or at discharge if sooner)?
    

Detailed description: 
      Fortified mother's milk or fortified formula is routine practice in neonatal units and is not
      an intervention.
    

Intervention name(s): Iron Supplement; multivitamin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): multivitamin that provides 2mg/kg/day of iron given orally to infants when they are tolerating 120 ml/dg/day of preterm formula or fortified breast milk until they reach 36 weeks adjusted postmenstrual age.; daily oral multivitamin without iron until 36 weeks adjusted postmenstrual age
Other intervention name(s): iron supplementation; Multivitamin without iron
Intervention MeSH terms: Iron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: very low birth weight infants; anemia; iron supplementation
Efficacy and Safety of Vildagliptin in Combination With Metformin in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a
      single oral drug. The purpose of this study is to assess the safety and effectiveness of two
      doses of vildagliptin, an unapproved drug, when added to metformin in people with type 2
      diabetes who are not at target blood glucose levels on metformin alone.
    


Intervention name(s): vildagliptin
Intervention type(s): Drug
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: type 2 diabetes; vildagliptin
Study to Assess the Effects of Daily Administration of Pioglitazone on Brain Hemodynamics in Healthy Elderly Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of pioglitazone, once daily (QD), on brain
      hemodynamics in healthy elderly participants.
    

Detailed description: 
      The study will evaluate the effects on resting-state networks before and after therapeutic
      intervention, and also on task-related brain networks after specific cognitive challenges.
    

Intervention name(s): Pioglitazone; Pioglitazone; Pioglitazone; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Pioglitazone once daily for up to 14 days.; Pioglitazone once daily for up to 14 days.; Pioglitazone once daily for up to 14 days.; Pioglitazone matching placebo once daily for up to 14 days.
Other intervention name(s): AD-4833; ACTOS; AD-4833; ACTOS; AD-4833; ACTOS
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Drug Therapy; pharmacodynamics; pharmacokinetics
Mephedrone and Alcohol Interactions in Humans
Condition: Amphetamine-Related Disorders; Alcohol-Related Disorders
MeSH terms: Alcohol-Related Disorders; Amphetamine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are 1) to evaluate the pharmacological effects after oral
      coadministration of mephedrone and alcohol and 2) determine the pharmacokinetics changes of
      mephedrone and alcohol concentrations after oral coadministration of mephedrone and alcohol.
    

Detailed description: 
      Mephedrone (4-methylmetcathinone, 4-MMC) is a new psychoactive substance (NPS). Mephedrone is
      frequently used in combination with alcohol. At present, the effects of the interaction
      between mephedrone and alcohol in humans have not been previously evaluated in randomized
      controlled clinical trials.

      The aims of this study are 1) to evaluate the pharmacological effects after oral
      coadministration of mephedrone and alcohol and 2) determine the pharmacokinetics changes of
      mephedrone and alcohol concentrations after oral coadministration of mephedrone and alcohol.
    

Intervention name(s): Mephedrone and alcohol; Mephedrone; Alcohol; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single oral dose mephedrone
Single oral dose alcohol; Single oral dose mephedrone; Single oral dose alcohol; Single oral dose placebo
Other intervention name(s): 4-methylmetcathinone; 4-MMC; Alcohol; 4-methylmetcathinone; 4-MMC; Non-active treatment
Intervention MeSH terms: Ethanol; Methamphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Bioequivalence Study in Patients With Schizophrenia by Using Clozaril 100 mg Tablet (Clozapine) and WID-CLZ18
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical study is a randomized, open label, multiple-dose, 2-way crossover, phase I
      (Bioequivalence) study to compare the safety and pharmacokinetics profile of WID-CLZ18 and
      Clozaril 100 mg tablet (Clozapine) after oral administration in schizophrenia patients.
    


Intervention name(s): Clozaril 100 mg (Clozapine); WID-CLZ18
Intervention type(s): Drug; Drug
Intervention description(s): 2 Doses/Day for 10 days; 2 Doses/Day for 10 days
Intervention MeSH terms: Clozapine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Red Grape Polyphenol Oral Administration to Women Affected by Nickel-mediated Allergic Contact Dermatitis
Condition: Allergic Contact Dermatitis
MeSH terms: Dermatitis; Dermatitis, Contact; Dermatitis, Allergic Contact
Study type: Interventional

Summary: 
      Nickel (Ni)-mediated allergic contact dermatitis (ACD) is a very common disease worldwide.
      Our previous findings demonstrated that in vitro supplementation of polyphenols, extracted
      from seeds of red grape (Nero di Troia cultivar), to peripheral lymphomonocytes from
      Ni-mediated ACD patients could reduce release of T helper (h)1 [interferon (IFN)-] and Th2
      [interleukin (IL)-4] cytokines, on the one hand. On the other hand, IL-10 (an
      anti-inflammatory cytokine) levels increased with a reduction of IL-17 (an inflammatory
      cytokine). Also levels of nitric oxide (NO) decreased in response to polyphenol pretreatment.
    

Detailed description: 
      Nickel (Ni) is a transitional metal largely distributed in the environment whose continuous
      exposure is able to provoke local and systemic allergic contact dermatitis (ACD). Ni-mediated
      ACD is characterized by loss of epidermal integrity, urticaria/angioedema, flares, and
      itching, whose extent depends on many variables such as genetic, time of sensitization and
      environmental exposure.The aim of the present research is to verify whether the oral
      administration of polyphenols (NATUR-OX®) to patients with Ni-mediated ACD is able to modify
      immune parameters.
    

Intervention name(s): NaturOx Group (A); Placebo Group (B)
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Comparison between dietary supplement and placebo; Comparison between dietary supplement and placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Allergic contact dermatitis; Cytokines; Cellular and molecular rehabilitation; Immune response; Nickel; Polyphenols
AZD6765 Single and Multiple Ascending Dose Study in Healthy Male and Female Japanese and Caucasian Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I randomized double-blind, placebo-controlled, single and multiple ascending
      dose study to assess the safety, tolerability and pharmacokinetics of AZD6765 in healthy male
      and female Japanese and Caucasian subjects
    


Intervention name(s): AZD6765; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single administration and once daily for 5 days; single administration and once daily for 5 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: AZD6765; Japanese and Caucasian Healthy Volunteers; Phase I study; Single and multiple Ascending Dose; Japanese volunteers
14 g vs. 16 g in Breast Biopsy
Condition: Breast Biopsy
Study type: Interventional

Summary: 
      Comparison of biopsy needles with a different diameter, i.e. 14 vs 16 gauge, used for breast
      biopsies
    


Intervention name(s): needle biopsy
Intervention type(s): Diagnostic Test
Intervention description(s): breast biopsy using different needle gauges
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Comparison of 14 vs 16 gauge needles
Masking: None (Open Label)
Primary purpose: Diagnostic
Feasibility Study Using Zone-MPC Controller, HMS and Technosphere® Insulin Inhalation System From MannnKind Corp
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This clinical trial is a feasibility study to assess the performance of an Artificial
      Pancreas (AP) device using the Artificial Pancreas System (APS©) platform for subjects with
      type 1 diabetes using rapid-acting insulin as well as preprandial inhaled insulin
      (Technosphere® Insulin Inhalation System by MannKind Corporation). The goal of this proposed
      study is to explore the feasibility of using multiple insulin delivery routes in order to
      mimic the physiology of both first- and second-phase insulin secretion. The intent is to
      exploit the rapid action achieved by inhaled insulin to compensate for part of the meals and
      utilize the conventional subcutaneous route for management of basal insulin and as
      second-phase meal-related insulin.
    


Intervention name(s): Investigational inhaled insulin (Technosphere); Artificial Pancreas (AP) device (APS©)
Intervention type(s): Drug; Device
Intervention description(s): by MannKind Corp. IND 61,729; Device includes:
OneTouch® Ping® Glucose Management System with modified Meter-Remote from Animas® Corp or the OmniPod® Insulin Management System from Insulet Corp.
Dexcom® G4® CGM System (CGM) from Dexcom® Corp
Control algorithm: zone-Model Predictive Control (zone-MPC) with safety Health Monitoring System (HMS)
Other intervention name(s): Technosphere® Insulin Inhalation System (Gen2C inhaler); Artificial Pancreas System platform (APS©) from the University of California, Santa Barbara and SDRI
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Pancrelipase; Pancreatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Iron-Deficiency Anemia in Infants in Two Weekly Programs
Condition: Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      This work aims at establishing the effectiveness of weekly doses of ferrous sulfate
      administered by mothers compared with weekly supplements administered directly by healthcare
      professionals, to reducing anemia prevalence.
    

Detailed description: 
      Some studies have shown satisfactory results in reducing the prevalence of iron deficiency
      using weekly doses of ferrous sulfate, thereby avoiding these side effects. This deficiency
      is the most common nutritional disorder during childhood and does not only affect individuals
      from developing countries but also those from industrialized nations.

      For infants with ages between six and 24 months, iron supplementation is the main treatment
      for iron deficiency. In this age range the prevalence of anemia is at least 20%. However,
      studies have shown a low rate of compliance by mothers during the recommended period, which
      may be caused by a lack of care or, more probably, due to the side effects caused by
      long-term daily ferrous sulfate supplementation, which include nausea, vomiting, diarrhea,
      staining of teeth and abdominal pain.

      This specific study is randomized clinical trial study, achieved in a government healthcare
      clinic in Sao Jose do Rio Preto, Sao Paulo, Brazil. This study was carried out using two
      intervention groups. All children received 12 weekly doses of 25 mg of elemental iron, either
      administered in the government healthcare clinic or at the children's home.

      The study showed treatment compliance in both groups. Prevalence of anemia for all children
      was 75% at the beginning of supplementation and 46.3% at the end of the period (p < 0.0005).
      Reduction rate for anemic children was 38.3%. Average increases in hemoglobin concentration
      levels were 0.75 g/dL and 0.65 g/dL, respectively, for home interventions and healthcare
      clinic administration (p < 0.00005).
    

Intervention name(s): elemental iron
Intervention type(s): Drug
Intervention description(s): Iron supplementation.
Other intervention name(s): doses of 25 mg of elemental iron
Intervention MeSH terms: Iron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Infants; Prevalence; Iron; Deficiency; Treatment
Internet Based Exercise Training in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Type 2 Diabetes Mellitus (DM) is a disease which is characterized with insulin resistance and
      exercise has positive effects on glycemic control and cardiovascular disease (CVD)
      development in these patients. Encouraging physical activity and exercise with using
      internet-based technology provides; potential to reach more people via comparatively low
      cost, 24 hour accessibility to services and for clinician, more frequent communication
      ability with the patient. In literature, there is no study examined exercise training via
      internet in patients with Type 2 DM. For this reason, considering the lack of the literature,
      the investigators aimed to compare the effects of internet based combined exercise training
      on glycemic control, functional capacity and physical activity level with supervised group
      training in patients with Type 2 DM. The purpose of the study is to provide convenience of
      rehabilitation access, glycemic control, offer an alternative physiotherapy and
      rehabilitation service which can help to improve physical activity level and obtain
      quantitative data for the applicability and contribution of internet based exercise training
      in patients with Type 2 DM.
    


Intervention name(s): Internet based exercise training; group exercise training; Physical activity counselling via a brochure
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 DM; internet based exercise training; group exercise training; glycemic control