bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Mild Hepatic Impairment on the Pharmacokinetics of Istradefylline
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test whether mild liver impairment affects blood levels of
      istradefylline in humans. Decreased liver function could possibly increase istradefylline
      levels.
    

Detailed description: 
      This is a multicenter, open-label, parallel group, single-dose study to determine the
      single-dose PK of istradefylline in subjects with mild hepatic impairment (HI) (Child-Pugh
      Class A) and in subjects with normal hepatic function. Ten subjects with mild HI (Child-Pugh
      Class A) and 10 subjects with normal hepatic function (matched for age, gender, race, and
      BMI) will be enrolled. Enrollment of the subjects with normal hepatic function will be
      subsequent to the HI subjects.
    

Intervention name(s): Istradefylline
Intervention type(s): Drug
Intervention description(s): One 40 mg-tablet administered on Day 1
Other intervention name(s): KW-6002
Intervention MeSH terms: Istradefylline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Mild hepatic impairment; Healthy volunteer; Istradefylline
Efficacy of Two Liquid Oxygen Devices in Deambulation
Condition: To Determine the Efficacy of Two Liquid Oxygen Device
Study type: Interventional

Summary: 
      Some oxygen conserving devices have been developed to diminish oxygen expense. These devices
      offer optimisation of oxygen therapy for deambulation by improving time autonomy of patients.
    


Intervention name(s): Oxygen conserving devices; Oxygen conserving devices
Intervention type(s): Device; Device
Intervention description(s): Three 6MWT test will be performed at random with conventional oxygen continuous-flow,by Oxymizer Pendant and demand valve system. The percentage of patients correcting their desaturation and patients' acceptance of every method will be determinated.; Three 6MWT test will be performed at random with conventional oxygen continuous-flow,by Oxymizer Pendant and demand valve system. The percentage of patients correcting their desaturation and patients' acceptance of every method will be determinated
Other intervention name(s): Oxygen conserving devices in COPD.; Oxygen conserving devices in interstitial lung disease.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Egg Diet to Improve Metabolic Health and Function
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of change in diet quality (carbohydrate
      restriction versus fat restriction) on body composition, fat distribution, cardiometabolic
      risk factors, physical function, and quality of life in aging adults with obesity.
    

Detailed description: 
      The purpose of this study is to determine the effects of change in diet quality (carbohydrate
      restriction versus fat restriction) on body composition, fat distribution, cardiometabolic
      risk factors, physical function, and quality of life in aging adults with obesity. Data from
      previous studies support the hypothesis that consumption of lower-CHO, higher-fat food
      sources rich in high-quality proteins and essential fatty acids, such as whole eggs, has
      beneficial effects on metabolic health. The study will test the hypothesis that a reduced CHO
      higher- fat, egg-rich diet induces selective depletion of total and abdominal adiposity,
      preserves lean mass, and reduces inflammation and oxidative stress. In turn, these favorable
      changes in body composition, fat distribution, and metabolic health will confer improvements
      in physical function in obese, aging adults.

      Results from this study will form an empirical basis for developing an easily implemented,
      non-pharmacologic treatment (i.e. change diet quality by incorporating more low carbohydrate,
      whole foods such as eggs) to prevent or reverse sarcopenia and other age-related diseases of
      metabolic origins.
    

Intervention name(s): Egg-based diet (EBD); Carbohydrate-based diet (CBD)
Intervention type(s): Other; Other
Intervention description(s): Participants will be asked to consume a carbohydrate-restricted diet including whole eggs for 8 weeks. Eggs will be provided.; Participants will be asked to consume a low fat, carbohydrate-based diet for 8 weeks. Breakfast food items will be provided.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: obesity; low carbohydrate diet; metabolism; body composition; visceral fat; older adults; insulin sensitivity
8 Weeks Treatment With DDP225 in Patients With Diarrhea Predominant IBS
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      In this study, female patients with IBS-d will be treated for 8 weeks to assess the safety
      and effectiveness of DDP225 on GI transit and in reducing IBS symptoms.
    

Detailed description: 
      This is a randomized, double-blind, placebo controlled, multicenter study designed to assess
      the safety and efficacy of DDP225 in patients with IBS-d. Female patients from 18 to 65 years
      of age with a history of IBS-d for at least 6 months are potentially eligible for entry into
      the study. A total of 88 eligible patients with IBS-d will be studied.

      The total duration of study participation for an individual patient is approximately 10 weeks
      (74 days) from the initial screening visit to final study evaluations. The total duration of
      dosing with study medication (either DDP225 or placebo) is 8 weeks.

      Patients who satisfy all of the inclusion criteria and none of the exclusion criteria are
      eligible to enter the Treatment Period and will be randomly assigned to one of four treatment
      groups.

      After a patient is randomized and enters the Treatment Period, she will take the appropriate
      study medication once a day for 56 days and return to the clinic at two week intervals for a
      total of four visits during the Treatment Period. During the Treatment Period, patients will
      maintain a daily diary and complete questionnaires. One week after completing the 56-day
      Treatment Period, patients return to the clinic for final safety evaluations which include a
      physical examination, electrocardiogram, and clinical laboratory testing.
    

Intervention name(s): DDP225
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: IBS-d, IBS
The Effects of Disease Management Programs for Prevention of Recurrent Ischemic Stroke
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Ischemia
Study type: Interventional

Summary: 
      It has been reported that stroke is the first cause of becoming bedridden, and its cumulative
      recurrence rate in 5 years is approximately 35%. There is a high probability that patients
      reduce or discontinue medications by self-determination, leading to a high risk of stroke
      recurrence in these patients. Comprehensive and long-term patient educations ameliorating
      their self-management are important making patients possible to be managed according to the
      guidelines for their risk factors. Using disease management programs created for each of risk
      factors according to clinical practice guidelines, the influence of those programs were
      evaluated for the prevention of stroke recurrence in this Disease Management Program Stroke
      Trial.
    


Intervention name(s): disease management; usual care
Intervention type(s): Other; Other
Intervention description(s): disease management program include self management education; usual care group receive regular outpatient treatment
Other intervention name(s): Intervention of disease management program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: stroke, disease management programs, self-management
A Study To Investigate The Safety And Efficacy Properties Of PF-00547659 In Patients With Active Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      study to investigate the safety and efficacy properties of PF-00547659 in patients with
      active ulcerative colitis
    


Intervention name(s): Single dose-group A; Single dose-group A; Multiple dose- Group B; Single dose-group A; Multiple dose- Group B; Single dose-group A; Single dose-group A; Single dose-group A; Single dose-group A; Multiple dose-Group B; Multiple dose- Group B; Multiple dose- Group B; Multiple dose- Group B; Multiple dose- Group B; Multiple dose-Group B
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): PF-00547659, single iv dose; PF-00547659, single iv dose; PF-00547659, multiple dose; PF-00547659, single iv dose; PF-00547659, multiple dose; PF-00547659, single dose; PF-00547659, single dose; PF-00547659, single dose; PF-00547659, single dose; PF-00547659, multiple dose; PF-00547659, multiple dose; PF-00547659, multiple dose; PF-00547659, multiple dose; PF-00547659, multiple dose; PF-00547659, multiple dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Characterization of the Analgesic Effect of CBD in Healthy, Normal Volunteers
Condition: Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this double-blind, placebo-controlled study is to determine the analgesic
      effects of cannabidiol (CBD), a chemical constituent found in cannabis that does not have
      intoxicating effects. The analgesic effects of CBD will be assessed using the Cold-Pressor
      Test (CPT), a laboratory model of pain which has predictive validity for the clinical use of
      analgesics.
    

Detailed description: 
      This within-subject, double-blind, placebo-controlled study will assess the analgesic and
      subjective effects of a range of CBD doses (0, 200, 400, or 800 mg, po). Volunteers will
      participate in 4 outpatient laboratory sessions over the course of 4 weeks during which the
      analgesic effects of CBD will be assessed using the Cold-Pressor Test (CPT), a laboratory
      model of pain which has predictive validity for the clinical use of analgesics. The order of
      CBD dose will be randomized across participants. Secondary measures will include subjective
      and physiologic effects of CBD.
    

Intervention name(s): Cannabidiol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 200, 400, or 800 mg Cannabidiol; 0 mg Cannabidiol
Other intervention name(s): CBD
Intervention MeSH terms: Cannabidiol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Dose Proportionality Study: Blood Levels of Fluticasone Furoate (FF) and Vilanterol (VI) Following Different Doses of FF/VI Via an Inhaler
Condition: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate dose proportionality of fluticasone furoate (FF)
      and equivalence of vilanterol (VI)following single dose administration of FF/VI via the novel
      dry powder inhaler in healthy subjects.
    

Detailed description: 
      The study will be an open-label, randomised, 3-way cross-over single dose study in 24 healthy
      subjects to demonstrate dose proportionality of fluticasone furoate (FF) and equivalence of
      vilanterol (VI) following single dose administration of FF/VI via the novel dry powder
      inhaler. In each of 3 treatment periods, subjects will receive 4 inhalations of 50/25 mcg,
      100/25 mcg, 200/25 mcg FF/VI. Blood samples will be taken for pharmacokinetic analysis and
      safety (12-lead ECGs, clinical laboratory test, vital signs, adverse events) will be
      monitored following each dose.
    

Intervention name(s): Fluticasone furoate 50 mcg (4 inhalations); Fluticasone furoate 100 mcg (4 inhalations); Fluticasone furoate 200 mcg (4 inhalations); Vilanterol 25 mcg (4 inhalations)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 4 inhalations of 50 mcg strength; 4 inhalations of 100 mcg strength; 4 inhalations of 200 mcg strength; 4 inhalations of 25 mcg strength
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
MINGO Supplemental Trial in X-linked Dystonia-Parkinsonism Patients
Condition: X-Linked Dystonia Parkinsonism
MeSH terms: Dystonia; Dystonic Disorders; Parkinsonian Disorders; Genetic Diseases, X-Linked
Study type: Interventional

Summary: 
      To see whether MINGO, a food supplement, will be able to lessen the drastic weight loss seen
      among X-linked Dystonia Parkinsonism patients.
    

Detailed description: 
      X-linked dystonia parkinsonism (XDP, formerly known as DYT3) occurs primarily in Filipino
      males and is characterized by neurodegenerative dystonia and parkinsonism. It is currently
      recognized to have wide phenotypic variability relating to age of onset, location of disease
      onset and rate of severity/disease progression. Most patients begin with focal dystonia that
      generalizes with the development of parkinsonism later in disease course. XDP patients suffer
      from severe nutritional loss due to symptoms such as dysphagia, loss of appetite, and
      consistently high metabolic requirements brought about by their movement disorder.
      Approximately 79% of patients with XDP have experienced rapid weight loss since the onset of
      their disease. It is the aim of the researchers to assess the clinical usefulness of adding a
      nutritional supplement to the daily dietary needs of these patients.

      MINGO is a supplement consisting of local ingredients such as moringa, rice and mung beans,
      which can be added to any type of edible paste, food, and liquid. Mingo has gained popularity
      as an emergency food in disaster relief operations due to the ease of its preparation, its
      high nutritional value and relatively low price. For the last two years, it has also been
      used as an agent for nutritional build up in malnourished populations of children. This study
      will provide valuable information on whether patients with XDP can increase their weight by
      consuming MINGO, which will lead to improvements in the patients' medical care and wellbeing.
    

Intervention name(s): MINGO
Intervention type(s): Dietary Supplement
Intervention description(s): 6 20oz sachets will be taken daily by intervention group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: prospective randomized trial
Hybrid Closed Loop Pivotal Trial in Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This study is a single-arm, multi-center, Home and Hotel Clinical Investigation in subjects
      with type 1 diabetes on insulin pump therapy. The purpose of this study is to demonstrate
      that the closed loop algorithm that is built into the 670G insulin pump is safe as part of
      the overall system.
    

Detailed description: 
      The study will proceed as follows:

      Run-in Period:

      A total of up to 150 subjects (age 14 - 75) will be enrolled at up to 10 investigational
      centers (9 in the US, 1 in the Europe, Middle East and Africa (EMEA) region) in order to
      reach 100 subjects who will complete the HCL study. The 2-week run-in period will be used to
      allow subjects to become familiar with new study devices. During the two week run-in period
      subjects will be using the Study Pump (670G) with the Sensor Augmented Pump function only
      activated (i.e. SmartGuard OFF and HCL OFF).

      Study Period - At Home:

      Following the two week run-in period using the Study Pump (670G), all subjects will
      participate in a 3-month study period.

      Subjects will be required to have a companion with them during the night for the duration of
      the study period. Companions will need to be under the same roof, but not necessarily in the
      same bedroom. During the Hotel stay where subjects are monitored closely, the presence of a
      companion is not necessary.

      Study Period - Hotel Study Subjects will participate in a Hotel study (6 days, 5 nights),
      with the remainder of the study period to be spent at home.

      All subjects will undergo daytime and nighttime Frequent Sample Testing (FST) for
      approximately 24 hours during the Hotel study with YSI or i-STAT® used as a reference value.

      With respect to meals, subjects will be allowed to eat as they normally do.

      Continued Access Program Subjects will be given the opportunity to extend use of their study
      devices for a period of 3 years. If subjects choose to participate in the continuation
      period, they will retain the study devices at the end of study period visit or receive them
      back in the event they have been returned to study staff already. During the continuation
      period, subjects will come in for office visits every 3 months. At each of the quarterly
      visits, subjects will be asked about the occurrence of adverse events and device complaints.
    

Intervention name(s): Insulin Pump
Intervention type(s): Device
Intervention description(s): Closed Loop Algorithm
Other intervention name(s): MMT-670G
Intervention MeSH terms: Insulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Danazol Treatment in Endometriosis Women Before IVF
Condition: Endometriosis; Ovarian Cysts; Infertility
MeSH terms: Ovarian Cysts; Infertility; Endometriosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether pre-treatment with danazol for at least 4
      months before controlled ovarian hyperstimulation for IVF cycles improves pregnancy rate.
    

Detailed description: 
      Endometriosis is a chronic benign disease defined by the presence of endometrial tissue
      outside the uterine cavity, affecting women in their reproductive age. This disease is
      clinically characterized by infertility pelvic pain and the presence of ovarian cysts,
      endometriomas, and affects the about 10% of women. Women with endometriosis when undergo IVF
      show lower pregnancy rate than general population, and a reduced ovarian reserve, due to the
      diseases and often to ovarian surgery. The aim of this study is to evaluate if a
      pre-treatment with danazol, an anti-estrogenic agent, may improve the otcome of IVF cycles in
      these women
    

Intervention name(s): Danazol; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg day for 4 monthh in women with diagnosed endometriosis before IVF; administered daily like the active comparator
Other intervention name(s): Danatrol
Intervention MeSH terms: Danazol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: endometriosis; ivf; ovarian reserve; danazol
Serum Resistin Level Following Non-surgical Periodontal Therapy in Diabetic Patients With Chronic Periodontitis
Condition: Type2 Diabetes
MeSH terms: Periodontitis; Chronic Periodontitis; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      non-surgical periodontal debridement was performed for diabetic patients with chronic
      periodontitis as well as for non-diabetic patients but also with chronic periodontitis. Serum
      resistin level was assessed in the two groups before and after periodontal therapy and also
      was compared to a healthy control group.
    

Detailed description: 
      Background: Resisitin is a recognized marker for chronic inflammatory conditions that could
      be directly linked with type 2 diabetes mellitus. The aim of this study was to assess serum
      resistin level in type 2 diabetic patients with chronic periodontitis.

      Methods: Forty individuals were recruited in this study and were divided into three groups,
      diabetic group consisted of 15 diabetic patients (type 2 diabetes mellitus) with moderate to
      severe chronic periodontitis, non-diabetic group consisted of 15 non-diabetic patients with
      moderate to severe chronic periodontitis and healthy group consisted of 10 non-diabetic
      individuals with healthy periodontium. Non-surgical periodontal therapy with supra and
      subgingival debridement was performed for the diabetic and non-diabetic groups. Pocket depth,
      clinical attachment level, plaque index, gingival index, serum Resistin and high sensitivity
      C-Reactive Protein assay were recorded for both groups before and after treatment, while
      HbA1c was recorded for the diabetic group.
    

Intervention name(s): non-surgical periodontal therapy
Intervention type(s): Procedure
Intervention description(s): supra and subgingival debridement
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: group1: diabetic patients with chronic periodontitis group2: non diabetic patients with chronic periodontitis
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence Study of GP30101 800 mg (GEROPHARM) Versus PREZISTA® 800 mg ("Jonson&Jonson", Russia)
Condition: Bioequivalence
Study type: Interventional

Summary: 
      Bioequivalence Study of GP30101 800 mg (GEROPHARM) Versus PREZISTA® 800 mg ("Jonson&Jonson",
      Russia)
    

Detailed description: 
      Study to evaluate the pharmacokinetic parameters, relative bioavailability and bioequivalence
      of drugs containing darunavir - GP30101 and Prezista® in healthy volunteers after single
      orally administered dose, under fed conditions A comparative analysis of adverse events
      aditionally conducted in this study.
    

Intervention name(s): GP30101; Prezista®; GP30101; Prezista®
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer; Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer; Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer; Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer
Other intervention name(s): First aIntervention Period; First aIntervention Period; Second Intervention Period; Second Intervention Period
Intervention MeSH terms: Darunavir
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover Assignment two-way crossover
Masking: None (Open Label)
Primary purpose: Basic Science