bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Epi-no Device on Pelvic Floor Dysfunctions
Condition: Pelvic Floor Disorders; Urinary Incontinence; Dyspareunia; Lacerations Perineal
MeSH terms: Urinary Incontinence; Pelvic Floor Disorders; Dyspareunia; Lacerations
Study type: Interventional

Summary: 
      Perineal injury is the most common maternal obstetric complication associated with vaginal
      delivery. Perineal traumas are associated with maternal morbidity, including pain, urinary
      and fecal incontinence, genital prolapses, dyspareunia, physical and psychological
      impairment. EPI-NO is a device with the objective of preparing and training the pelvic floor
      for normal childbirth, this training allows smooth and slow movement along the perineal
      structures in the prenatal period, by causing a rapid traumatic laceration during childbirth.
      The objective of this study is to verify the effect of 10 pelvic stretching rows with Epi-No
      in preventing urinary incontinence and dyspareunia 6 months after delivery. The study group
      will consist of primiparous, over 18 years of age, between 30 and 32 weeks of gestation, will
      be evaluated before the intervention and 6 months after delivery. The control group will be
      evaluated only once, in the sixth month after delivery. The evaluation will consist of:
      anamnesis, physical examination (vaginal examination and palpation), perineometry,
      International Urinary Incontinence Questionnaire (ICIQ-UISF), Visual Analogue Scale for
      dyspareunia; Questionnaire for assessing dyspareunia Female Sexual Function Index (FSFI).
      Pregnant women referred for intervention will perform 10 sessions (twice a week for 5 weeks)
      of perineal preparation with the Epi-No device. It is expected at the end of the study to
      prove the effectiveness of the effect of 10 pelvic lengthening graft with Epi-No in relation
      to the degrees of laceration and episiotomy and, consequently, reduction of urinary
      incontinence and dyspareunia.
    


Intervention name(s): Epi-No®; Evaluation
Intervention type(s): Device; Diagnostic Test
Intervention description(s): evaluation, 10 sessions (twice a week for 5 weeks) of perineal preparation with the Epi-No device and revaluation six months after delivery.; evaluation (anamnesis, childbirth data, perineometry, International Consultation on Incontinence Questionnaire - Short Form, Female Sexual Function Index) six months after vaginal delivery.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: case-control study
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Epi-no device; vaginal birth
Impact of Cashew Nuts in the Human Diet: Measured Energy Value and Effects on Cardiovascular Disease Risk Factors
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      This study evaluates the effect of cashew nut consumption on traditional and emerging markers
      of cardiovascular disease (CVD) risk and determines the usable energy content of a serving of
      cashew nuts for accurate food labelling.
    

Detailed description: 
      The cardioprotective effects of nuts have been well documented in the scientific literature;
      however, most of the research has been done with almonds, walnuts, and pistachios, while
      studies with cashew nuts are lacking. In addition to the cardiovascular literature, our
      recent studies measuring the metabolizable energy of nuts have demonstrated that the measured
      energy value of almonds, pistachios, and walnuts is lower than that predicted using the
      Atwater factors. However, the measured energy value of cashew nuts is unknown. There are two
      distinct aims of this study - determining the effects of cashew nut consumption on risk
      factors of CVD, and determining the energy value of cashew nuts in the human diet. The
      cardiovascular effects of cashew nuts will be determined by measuring both traditional and
      emerging risk factors. The metabolizable energy value of cashew nuts will be calculated based
      on the chemical composition and energy content of the consumed diet and excreta. This will
      provide a better estimate of the energy value than simply calculating energy value based on
      Atwater factors.
    

Intervention name(s): Base Diet; Base Diet with Cashew Nuts
Intervention type(s): Other; Other
Intervention description(s): Participants will receive a controlled diet with 0 g/d of cashew nuts. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.; Participants will receive a controlled diet with 42 g/d of cashew nuts. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Postnatal Nutrition and Physical Activity in Obese Asthmatic Children
Condition: Obesity; Asthma in Children
MeSH terms: Asthma; Obesity
Study type: Observational

Summary: 
      The aim of this study was to compare the duration of breast milk intake, vitamin D intake,
      asthma control level and physical activity levels between obese asthmatic children and
      non-obese children. This was a prospective study in children aged 8-17 years with asthma.
      Asthma control level was evaluated by asthma control test and physical activity level was
      evaluated by Physical Activity Questionnaire for Children (IPAQ-C) and leisure time activity
      scale.
    

Detailed description: 
      Asthma and obesity, which are important public health problems and are common in childhood,
      are chronic diseases. The aim of this study was to compare breastfeeding duration, vitamin D
      intake, asthma control and physical activity levels between obese asthmatic children and
      non-obese children.

      The study was a prospective study conducted in children aged 8-17 years with asthma.
      Demographic information of the children was recorded. Asthma control level was assessed by
      asthma control test and physical activity level was assessed by Physical Activity
      Questionnaire for Children (IPAQ-C) and leisure time activity scale.

      It was conducted as a single-blind, prospective study in which the patients were randomized
      by simple randomization method as obese asthmatic children (experimental group) and non-obese
      asthmatic children (control group) according to the order of admission to the hospital.
    

Intervention name(s): Descriptive questionnaire
Intervention type(s): Other
Intervention description(s): Questionnaires were administered to calculate whether the children were obese or not, to determine their asthma control levels, to determine their physical activity levels and to determine their leisure time activities.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Volunteer children between the ages of 8-17 years with a diagnosis of asthma admitted to
        the Department of Pediatrics.
      
Keywords: Childhood asthma; Obesity; Physical activity; Postnatal nutrition
Gadolinium Texaphyrin Plus Radiation Therapy in Treating Patients With Supratentorial Glioblastoma Multiforme
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioblastoma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as
      gadolinium texaphyrin may make tumor cells more sensitive to radiation therapy.

      PURPOSE: Phase I trial to study the effectiveness of gadolinium texaphyrin plus radiation
      therapy in treating patients who have supratentorial glioblastoma multiforme that has not
      been previously treated.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the toxic effects of gadolinium texaphyrin administered to patients
      receiving cranial radiotherapy for glioblastoma multiforme. II. Determine the maximum
      tolerated dose of this regimen in these patients. III. Determine the pharmacokinetic profile
      of this regimen in these patients. IV. Determine the biodistribution of gadolinium texaphyrin
      in both neoplastic tissue and normal brain parenchyma. V. Evaluate the effect and
      accumulation of this regimen in normal brain parenchyma and neoplastic tissue by following
      the change in enhancing volume and percent change in signal intensity over time.

      OUTLINE: This is an open label, multicenter study. Arm I: Patients receive radiotherapy once
      a day, 5 days a week, for 6 weeks. Gadolinium texaphyrin IV is administered every other day
      within 2-5 hours prior to radiotherapy. Patients are evaluated at 1 month, and if no more
      than 1 of 3 patients experiences unacceptable toxicity, 3 patients are entered on the imaging
      portion of the study. Once arm I has successfully entered 3 patients with acceptable toxicity
      profiles and 3 patients in the imaging portion of the study, patient enrollment begins for
      arm II. Arm II: Cohorts of 3-9 patients receive radiotherapy as in arm I and escalating doses
      of gadolinium texaphyrin IV administered within 2-5 hours prior to each radiation dose. The
      maximum tolerated dose (MTD) of gadolinium texaphyrin is defined as the dose at which no more
      than one third of the patients experience dose limiting toxicity. Arm III: Patients
      experiencing dose limiting toxicity in arm II requiring dose reduction below predetermined
      once a day limit receive gadolinium every other day, with radiotherapy as in arm II. The MTD
      is defined as in arm II. Arm IV: An additional 3 patients are enrolled at the MTD and enter
      the imaging portion of the study. Patients are followed for 1 month after final radiation
      therapy.

      PROJECTED ACCRUAL: At least 18 patients will be accrued for this study within 6 months.
    

Intervention name(s): motexafin gadolinium; radiation therapy
Intervention type(s): Drug; Radiation
Intervention MeSH terms: Motexafin gadolinium
Primary purpose: Treatment
Keywords: adult glioblastoma; adult giant cell glioblastoma; adult gliosarcoma
The Effects of Modafinil on Waking Function and on Sleep in Individuals With Primary Insomnia
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      This study examines how treatment with the drug modafinil, by itself or in combination with
      cognitive behavioral treatment for insomnia (CBT-I), may improve daytime functioning and/or
      diminish the severity of insomnia.
    

Detailed description: 
      Our primary goal is to undertake a 2nd study evaluating whether Modafinil, alone or in
      combination with behavioral treatment for insomnia, will improve subjects' sleep continuity
      and/or self report daytime function.

      METHODS AND PROCEDURES

      Schedule for Procedures.

      Screening interview Sleep over night in our lab for one night 8 weeks of either behavioral or
      psychological therapy for insomnia 3 month post therapy follow up (two weeks of sleep diaries
      and one lab visit)

      40 patients aged 25-80 with insomnia. All subjects will have a stable sleep/wake schedule
      with a preferred sleep phase between 10:00 PM and 8:00 AM. The age range is restricted to 1)
      minimize circadian rhythm influences on the diagnoses of Psychophysiological insomnia, 2) to
      increase our ability to recruit medically healthy sample, and 3) increase sample homogeneity.

      All subjects will meet diagnostic criteria for Psychophysiological Insomnia according to the
      International Classification of Sleep Disorders (ICSD). Criteria are: the complaint of
      insomnia and impaired daytime function; an indication of learned sleep-preventing
      associations and somatized tension; active help seeking. The complaint of disturbed sleep
      will have one or more of the following characteristics: >30 minutes to fall asleep and/or >2
      awakenings per night of >15 minutes duration and/or wake after sleep onset time of > 30
      minutes, problem frequency >4 nights/ week, and problem duration >6 months. In addition, all
      subjects will complain of fatigue and/or sleepiness at intake.

      Treatment.

      Regardless of group assignment, all subjects will 1) wear an actiwatch, 2) be seen on an
      individual basis for 8 weeks. Session length will be held constant and all patients will be
      seen by the same therapist (Wilfred Pigeon, PhD). Backup support will be provided by the
      Principal Investigator (Michael Perlis, PhD) or by the Clinic's Nurse Practitioner (Carla
      Jungquist, MSN) and 3) complete daily sleep diaries for duration of the study (from study
      intake until study end [8 weeks]).
    

Intervention name(s): CBT-I; modafinil
Intervention type(s): Behavioral; Drug
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: primary insomnia, stimulants, cognitive behavioral therapy
The Safety Of Combo Formulation In The Treatment Of Multiple Episodes Of Acute Migraine Over 12 Months
Condition: Migraine Headaches
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to assess the safety of a single-tablet dose of Combo
      Formulation for the treatment of moderate to severe migraines
    

Detailed description: 
      The objective of this study is to assess the safety of a single-tablet dose of Combo
      Formulation for the treatment of moderate to severe migraines, with an optional second dose
      at least 2 hours following the first dose, if needed. Combo Formulation will be administered
      on average at least twice per month for 12 months.
    

Intervention name(s): Sumatriptan and Naproxen sodium
Intervention type(s): Drug
Intervention MeSH terms: Naproxen; Sumatriptan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Migrane headaches
A Pilot Study Using Weightloss and Exercise to Prevent Recurring Gestational Diabetes in Obese Women
Condition: Gestational Diabetes
MeSH terms: Diabetes, Gestational; Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to examine the feasibility of recruiting and providing a
      behavioral weight loss program prior to pregnancy to reduce gestational diabetes recurrence.
    


Intervention name(s): Prevention of recurrent gestational diabetes through weight loss and exercise (English & Spanish); Lifestyle education (English & Spanish)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Intervention groups will attend weekly sessions focused on healthy weight loss, healthy eating, exercise.; The lifestyle education group will focus on learning about healthy eating, and healthy activity. This group will also learn stress reduction techniques as well as new ways of increasing activity. Group will meet one time per month for 3 months, then once a month until conception.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Recurring Gestational Diabetes; Prevention
Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 1)
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this trial is to evaluate the efficacy and safety of two different treatment
      regimens with BI 201335, both in combination with PegIFN/RBV) as compared to standard of care
      (SOC) with PegIFN/RBV alone.
    


Intervention name(s): PegIFN/RBV; BI 201335; BI 201335; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): PegIFN/RBV for 48 weeks; BI 201335 once daily high dose; BI 201335 once daily low dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Efficacy and Safety Evaluation of Azimilide or Sotalol vs Placebo for Treatment of Patients With Atrial Fibrillation.
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 3

Summary: 
      Atrial fibrillation (abnormal rhythm in the upper chamber of the heart) is a common
      supraventricular arrhythmia (a type of abnormal heart rhythm) for which antiarrhythmic
      therapy is often prescribed. The primary goals of therapy are to maintain sinus rhythm
      (normal heart rhythm) and to reduce the occurrence of episodes of atrial fibrillation.

      The double-blind, placebo-controlled phase of this study is designed to evaluate the efficacy
      and safety of oral azimilide compared with placebo and with sotalol, an antiarrhythmic drug,
      in maintaining sinus rhythm in patients who require cardioversion (electric shock to correct
      heart rhythm) to correct atrial fibrillation. Once this phase of the study is completed, a
      second phase with a different study design will be conducted. The second phase is an
      open-label, follow-up phase to the first study. The follow-up phase will continue to evaluate
      the long-term safety of a daily oral dose of azimilide in patients who complete the
      double-blind, placebo-controlled phase of this study.
    


Intervention name(s): Azimilide Dihydrochloride; Placebo; Sotalol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 125 mg azimilide tablets, twice a day for 6 months; tablets, twice daily for 6 months; 160 mg sot twice daily for 6 months
Intervention MeSH terms: Sotalol; Azimilide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy of TAK-559 in Treating Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to determine the safety and efficacy of TAK-559, once daily
      (QD), in Type 2 Diabetes subjects.
    

Detailed description: 
      Insulin is a primary regulator of blood glucose concentrations. A subnormal response to
      circulating insulin levels at target tissues leads to a decrease in insulin-mediated glucose
      uptake. Insulin resistance is associated with normal to high insulin levels and is often
      accompanied by dyslipidemia, a disruption in lipid metabolism resulting in increased
      triglycerides and low-density lipoprotein levels as well as decreased high-density
      lipoprotein levels in patients with type 2 diabetes mellitus. In the early stages of insulin
      resistance, a compensatory mechanism of increased insulin secretion by the pancreas maintains
      normal to near-normal glucose levels. Once the pancreas fails to maintain the increased
      insulin output, overt type 2 diabetes mellitus occurs.

      TAK-559 is a novel oxyiminoalkanoic acid under investigation for use as an oral agent in the
      treatment of patients with type 2 diabetes mellitus. TAK-559 has partial peroxisome
      proliferator-activated receptor-alpha agonist activity, potent peroxisome
      proliferator-activated receptor-alpha activity, and modest peroxisome proliferator-activated
      receptor-gamma activity at high concentrations in nonclinical models.

      This study was designed to evaluate the safety and glycemic control of TAK-559 in patients
      with type 2 diabetes mellitus whose symptoms were managed by diet and exercise.
    

Intervention name(s): TAK-559; TAK-559; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): TAK-559 16 mg, tablets, orally, once daily for up to 26 weeks.; TAK-559 32 mg, tablets, orally, once daily for up to 26 weeks.; TAK-559 placebo-matching tablets, orally, once daily for up to 26 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glucose Metabolism Disorder; Dysmetabolic Syndrome; Type II Diabetes; Diabetes Mellitus, Lipoatrophic; Dyslipidemia; Drug Therapy
A 24-Hour Pharmacokinetic Determination of BG00012 After Single-Day Oral Administration in Subjects With MS
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      To establish a pharmacokinetic (PK) profile of BG00012, as measured by its primary
      metabolite, monomethyl fumarate (MMF), during a 24-hour dosing period in subjects with
      relapsing-remitting multiple sclerosis (RRMS), with a variety of baseline demographic
      characteristics.
    


Intervention name(s): BG00012; BG00012
Intervention type(s): Drug; Drug
Intervention description(s): 240 mg (two 120 mg capsules) orally three times a day; 240 mg (two 120 mg capsules) orally twice a day
Intervention MeSH terms: Dimethyl Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Pharmacokinetic and Mass Balance Study of Orally Administered [14C]-AZD4205 in Healthy Adult Male Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, open label, healthy volunteers, ADME study with single oral administration
      of [14C]-AZD4205.
    

Detailed description: 
      Phase I study to evaluate the excretion of AZD4205 radioactive dose, the metabolic profile,
      pharmacokinetics, safety and tolerability following a single oral administration of
      [14C]-AZD4205 in healthy male volunteers. The purpose of this study is to investigate ADME
      properties of AZD4205 by analyzing blood, urine and feces collected during the study
    

Intervention name(s): [14C]-AZD4205, single 50 mg oral dose administrated on day 1
Intervention type(s): Drug
Intervention description(s): Each subject will receive 50 mg AZD4205 oral solution (free base equivalent) containing a nominal dose of 15 µCi [14C]- radiolabelled AZD4205 as a single administration .
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Acetaminophen Transfer Across the Placenta and the Assessment of Fetal Well-being
Condition: Fetal Testing; Transplacental Transfer of Acetaminophen
Study type: Interventional
Phase: Phase 1

Summary: 
      This study has two aims:

        1. to evaluate placental transfer of acetaminophen from mother to baby transplacentally
           given from 30 minutes to 24 hours prior to cesarean delivery (34 patients)

        2. to understand the impact of maternal acetaminophen use on fetal movement and breathing
           (20 patients)
    


Intervention name(s): Arm 1 (20 patients); Arm 2 (34 patients)
Intervention type(s): Drug; Drug
Intervention description(s): Acetaminophen 1000 mg by mouth once; Acetaminophen 1000 mg by mouth once
Other intervention name(s): Tylenol; Tylenol
Intervention MeSH terms: Acetaminophen
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Fetal movement; Fetal breathing; Acetaminophen