bioihbjkbjnl/mcl2 huggingface dataset:
Endometrial Follicular Fluid Flushing and IVF Outcome
Condition: Clinical Pregnancy
MeSH terms: Flushing
Study type: Interventional

Summary: 
      Objective: In this study, our aim will be investigating the pregnancy results in unexplained
      infertile women undergoing ICSI, by flushing the endometrial cavity with folliculer fluid,
      that we maintain mature follicules inside them in oocyte retrieval day.

      Study Design: 100 subfertile women who applied to Zeynep Kamil Hospital, In Vitro
      Fertilization Center between October 2016 to May 2017 will be randomized with computer
      generated programme. The patients will be divided into two groups; follicular fluid group
      (n=50) and control group (n=50). The inclusion criterias are: age between 20-39 years, basal
      FSH level < 10 mIU/ml, body mass index<35 kg/m2 and E2 levels in human chorionic gonadotropin
      (hCG) day between 1000-4000 pg/ml. Patients meets these criteria will be included to the
      study programme. The exclusion criteria are determined as below: previously diagnosed
      endometriosis, uterine leiomyomas, hydrosalpinx, endocrinological disorders; previous history
      of implantation failure in IVF/ICSI cycles and severe male factor infertility.
    

Detailed description: 
      Objective: In this study, our aim will be investigating the pregnancy results in unexplained
      infertile women undergoing ICSI, by flushing the endometrial cavity with folliculer fluid,
      that we maintain mature follicules inside them in oocyte retrieval day.

      Study Design: 100 subfertile women who applied to Zeynep Kamil Hospital, In Vitro
      Fertilization Center between October 2016 to May 2017 will be randomized with computer
      generated programme. The patients will be divided into two groups; follicular fluid group
      (n=50) and control group (n=50). The inclusion criterias are: age between 20-39 years, basal
      FSH level < 10 mIU/ml, body mass index<35 kg/m2 and E2 levels in human chorionic gonadotropin
      (hCG) day between 1000-4000 pg/ml. Patients meets these criteria will be included to the
      study programme. The exclusion criteria are determined as below: previously diagnosed
      endometriosis, uterine leiomyomas, hydrosalpinx, endocrinological disorders; previous history
      of implantation failure in IVF/ICSI cycles and severe male factor infertility.
    

Intervention name(s): follicular fluid flushing
Intervention type(s): Other
Intervention description(s): Follicular fluid obtained during OPU will be used for endometrial cavity flushing.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigating the Efficacy of Brain Octane® Oil on Cognition, Coordination, Reaction Time and Measurements of Physical Performance in Recreationally Active Adults
Condition: Healthy
Study type: Interventional

Summary: 
      This is a randomized, double-blind, placebo-controlled, parallel study investigating the
      efficacy of Brain Octane® Oil on cognition, coordination, reaction time and measurements of
      physical performance in recreationally active adults. Thirty eligible participants will
      consume the investigational product or placebo for 27 days. 15 participants will consume the
      investigational product and 15 participants will receive the placebo product to consume.

      The primary outcome is assessing reaction time, cognition, and the ability to perform
      cognitive tasks. Assessments will be conducted at baseline, and end of study (30 days apart).
    


Intervention name(s): Brain Octane Oil; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Participants will complete a 7-day dose escalation period, and then consume 2 servings of the study product (1 serving = 1 tablespoon) for 21 days.; Participants will complete a 7-day dose escalation period, and then consume 2 servings of the study product (1 serving = 1 tablespoon) for 21 days.
Other intervention name(s): caprylic acid triglycerides; High Oleic Sunflower Oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Cognition; Healthy; Brain Octane Oil; Caprylic acid triglycerides; Physical performance
A Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-55375515 in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess safety and tolerability of day-time and night-time
      dosing of JNJ-55375515 in healthy male participants.
    


Intervention name(s): JNJ-55375515 Dose Level 1; JNJ-55375515 Dose Level 2; JNJ-55375515 Dose Level 3; JNJ-55375515 Dose Level 4; JNJ-55375515 Dose Level 5; JNJ-55375515 Dose Level 6; Placebo; JNJ-55375515
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive JNJ-55375515 orally at a Dose level 1 in Part 1 of study.; Participants will receive JNJ-55375515 orally at a Dose level 2 in Part 1 of study.; Participants will receive JNJ-55375515 orally at a Dose level 3 in Part 1 of study.; Participants will receive JNJ-55375515 orally at a Dose level 4 in Part 1 of study.; Participants will receive JNJ-55375515 orally at a Dose level 5 in Part 1 of study.; Participants will receive JNJ-55375515 orally at a Dose level 6 in Part 1 of study.; All participants will receive matching placebo orally in Part 1 and Part 2 of the study.; Participants will receive JNJ-55375515 as per the assigned treatment in Part 2.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Smoking, Sex Hormones, and Pregnancy
Condition: Nicotine Dependence; Contraception
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators aim to (1) examine the association between levels of progesterone (Prog),
      allopregnanolone (Allo), and the estradiol/progesterone (E2/P) ratios with smoking-related
      symptomatology during ad libitum smoking and (2) determine the association between Prog,
      Allo, and E2/P with the changes in smoking-related symptomatology and response to nicotine
      following overnight abstinence
    

Detailed description: 
      The sample population will consist of oral contraceptive users, both "low" and "high" dose
      levels of exogenous progesterone with a consistent dose of exogenous estrogen. Participants
      will complete data collection procedures including providing saliva (cortisol to measure
      stress), urine (cotinine and 3-Hydroxycotinine to measure nicotine exposure), and blood
      (progesterone, allopregnanolone, and estradiol) samples, as well as ecological momentary
      assessments (EMA) daily for seven-days. Participants will also complete a 3-hour smoking
      topography lab session after overnight abstinence and a 4.5-hour nicotine nasal spray lab
      session after a 14-hour abstinence. These sessions will contain a nicotine challenge via
      smoking a cigarette or nasal spray with timed-series physiological, subjective, and
      behavioral responses.
    

Intervention name(s): Low-dose Progesterone; High-dose Progesterone
Intervention type(s): Drug; Drug
Intervention description(s): The "low" progesterone dose is seven days of placebo Tri-sprintec + placebo generic Prometrium twice a day (7AM and 7PM).; The "high" progesterone dose is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice a day (7AM and 7PM).
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Ombitasvir /Paritaprevir/Ritonavir Plus Ribavirin on HCV GT4
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective of the investigators was to delineate the efficacy and safety of Ombitasvir,
      paritaprevir with ritonavir (OBV/PTV/r) plus ribavirin (RBV) on chronic HCV GT4 Egyptian
      naïve patients
    

Detailed description: 
      Direct-acting antivirals (DAAs) combination therapies from various mechanisms of action and
      families have been revolutionized the management landscape of chronic hepatitis C virus
      (HCV). Ombitasvir, paritaprevir with ritonavir (OBV/PTV/r) ± ribavirin (RBV) are approved to
      treat HCV genotype 4 (GT4) infection. Here, investigators' objective was to delineate the
      efficacy and safety of OBV/PTV/r plus RBV of HCV GT4 in the treatment of Egyptian naïve
      patients.

      Between 5 January and 8 September 2017, a cohort of 100 Egyptian patients infected with HCV
      GT4 was allocated and administered orally OBV/PTV/r with RBV, for 12 weeks, which given as
      oral tablets based on patient tolerability. The primary endpoint of investigators' study was
      a sustained virological response (HCV RNA < 12 IU/mL) 12 weeks from the cessation of the
      treatment (SVR12).
    

Intervention name(s): OBV/PTV/r) ± ribavirin (RBV)
Intervention type(s): Drug
Other intervention name(s): Paritaprevir (ABT-450) is inhibitor of the NS3-4A serine protease Ombitasvir (ABT 267) is an NS5A inhibitor
Intervention MeSH terms: Ribavirin
Intervention model: Single Group Assignment
Intervention model description: 100 Egyptian naive patients infected with HCV GT4 was allocated and administered orally OBV/PTV/r with RBV which given as oral tablets based on patient tolerability
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ombitasvir; Paritaprevir; Ritonavir; Ribavirin; HCV; Genotype 4; Naïve; Egyptians
A Study in Healthy Men to Test How BI 1358894 is Taken up and Handled by the Body
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the basic pharmacokinetics of BI 1358894
      and its metabolites, total radioactivity, including mass balance, excretion pathways and
      metabolism following a single oral dose of [14C] BI 1358894 in Part 1 and to investigate the
      pharmacokinetics of BI 1358894 and its metabolite(s) following multiple-dose treatment over
      21 days with non- radiolabelled compound of BI 1358894 in Part 2.
    


Intervention name(s): [14C]-radiolabelled BI 1358894; BI 1358894
Intervention type(s): Drug; Drug
Intervention description(s): Part 1; Part 2
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Body Weight Gain, Parkinson, Subthalamic Stimulation
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Body Weight; Weight Gain
Study type: Interventional
Phase: Phase 2

Summary: 
      Chronic bilateral subthalamic stimulation leads a spectacular clinical improvement in
      patients with motor complications. However, the post-operative body weight gain involved may
      limit the benefits of surgery and induce critical metabolic disorder. The aim of this study
      to determine the energy expenditure in usual conditions of life.
    

Detailed description: 
      Patients will be studied before (between 3 and 1 months) and after (1 month) STN-DBS surgery.
      Each time the same measurements will be taken. The principal ones will be :

        -  Clinical examination

        -  Autoevaluation dietary questionnaire

        -  Biological tests

        -  Study in calorimetry chamber (only in Clermont-Ferrand centre)

        -  Heart rate recorded during 7 days in usual conditions of life

        -  Energy expenditure recorded during 14 days in usual conditions of life with normalized
           water (18O 10 %) and Deuterium oxide (99.94 %D)

        -  Acute Ldopa challenge (in both conditions of dopa and stim)

        -  Apathy evaluation

        -  Body weight, and body compositions measurements
    

Intervention name(s): Energy metabolism by chronic bilateral subthalamic stimulation
Intervention type(s): Behavioral
Intervention description(s): Patients will be studied before and after STN-DBS surgery
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Energy metabolism, metabolic syndrome, by chronic bilateral subthalamic stimulation, Parkinson's disease; Patients with Parkinson's disease and will be treated by chronic bilateral subthalamic stimulation.
ProAliFun_6.5_Health Effects of a Functional Pasta Enriched With Barley Beta-glucans on Healthy Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the healthy properties of a dietary intervention
      based on an innovative pasta enriched with prebiotic fibers (barley beta-glucans).

      The hypothesis is that the gut microbiota and metabolome, the nutritional status, the
      redox/subclinical inflammation parameters and the markers of cardiovascular risk may improve
      in healthy subjects.
    

Detailed description: 
      This clinical trial is a prospective pilot study, lasting 4 months. A target number of 30
      healthy individuals meeting inclusion and exclusion criteria, assessed at enrollment, and
      which have signed the informed consent, will be recruited.
    

Intervention name(s): Beta-glucans
Intervention type(s): Dietary Supplement
Intervention description(s): 2 months Mediterranean Diet-based free diet (run-in) + 2 months Mediterranean Diet-based free diet with a daily supplementation of 100 g of beta-glucans pasta (intervention). Medical visits, dietary counselling with food frequency questionnaires administration, blood, urine and feces collection were performed before (T0) and after (T2) the two months of beta-glucans intervention.
Other intervention name(s): Functional pasta enriched with barley beta-glucans
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: beta-glucans; gut microbiota; p-cresyl sulphate (pCS); indoxyl sulphate (IS); short-chain fatty acid (SCFA)
Examination of Sleep, Smoking Cessation, and Cardiovascular Health
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      Most treatment-seeking smokers will fail in their attempts to quit smoking in the early days
      and weeks of quitting. Poor sleep (e.g., short duration) is an overlooked, but important
      nicotine withdrawal symptom that can affect up to 80% of treatment seeking smokers and
      predicts relapse. Addressing sleep deficits could promote cessation, particularly in smokers
      who may be vulnerable to poor sleep in one or more sleep metrics even before quitting. This
      study will address this conceptual and empirical gap by conducting a 15-week proof-of-concept
      study to determine whether standard smoking cessation treatment can be optimized with a
      multi-metric sleep advancement counseling intervention.
    

Detailed description: 
      The current study is a randomized controlled trial designed to test the impact and efficacy
      of a sleep advancement counseling (SAC) protocol in response to standard nicotine dependence
      treatment (behavioral counseling + varenicline) in a sample of 90 treatment seeking smokers
      from the greater Newark city/Newcastle county area. Following eligibility assessment, which
      include an overnight polysomnography (sleep study), 90 eligible and consenting
      treatment-seeking smokers will be randomized to either the experimental smoking cessation +
      SAC (N=60), or the control, smoking cessation + general health education (GHE) alone (N=30)
      condition. Participants will complete six in-person counseling sessions over a 15-week
      treatment period (wks 1, 3, 4,7,11,15) As part of the smoking cessation treatment protocol,
      eligible participants will receive 12 weeks of FDA-approved smoking cessation medication,
      Varenicline, during week 3-15. An end of treatment (week 15) and a 12-week follow-up (week
      27) assessment will be conducted in-person to allow for the objective assessment of smoking
      status and cardiovascular markers.
    

Intervention name(s): Sleep Advancement Counseling; General Health Information
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will receive cognitive behavioral counseling on achieving adequate sleep duration.; Participants will receive educational information on general health topics including diet, physical activity, skin protection, oral health and cancer screenings.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking; Smoking cessation; Nicotine
A Study Comparing the Effectiveness and Safety of Extended Release Tramadol HCl at 100 mg, 200 mg and 300 mg Doses to Placebo for the Treatment of Moderate to Severe Pain Due to Osteoarthritis (OA)
Condition: Chronic Pain
MeSH terms: Osteoarthritis; Chronic Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the analgesic efficacy and safety of tramadol HCl ER
      100 mg, 200 mg and 300 mg once a day (QD), with placebo in patients with moderate to severe
      pain due to OA. For the purposes of this study, celecoxib will serve as a positive control to
      validate the sensitivity of the model. The study hypothesis is that tramadol HCl ER is safe
      and effective in the treatment of moderate to severe pain due to OA.
    

Detailed description: 
      Immediate release (IR) tramadol has demonstrated efficacy in several pain conditions
      including, obstetrical, gynecological, orthopedic, abdominal, and oral surgery. The short
      elimination half-life of IR tramadol necessitates every 4-6 hour dosing to maintain optimum
      levels of analgesia in chronic pain. The study medication in this study is a once-daily,
      extended release (ER) tramadol formulation. This is a 12-week multicenter, double-blind,
      randomized, dose-ranging, placebo and positive-controlled, parallel-group study. For the
      purpose of this study, celecoxib serves as a positive control to validate the sensitivity of
      the model. Patients with OA functional Class I-III of the knee or hip, with moderate to
      severe pain are eligible for participation, if appropriate criteria are met. During a 2-7 day
      washout period, the use of all analgesic medications will be discontinued. Eligible patients
      experiencing moderate to severe pain (>= 40 mm on a 100 mm visual analog scale) in the index
      joint to be evaluated and who meet all other study criteria will enter the double-blind
      titration period. During this period, patients will be randomly assigned to receive treatment
      with tramadol HCl ER 100 mg, 200 mg, 300 mg, celecoxib 200 mg or placebo, once daily. During
      the titration period (Days 1-9) all patients will be contacted by phone every few days to
      ensure they do not experience unmanageable pain or unacceptable side effects. Efficacy and
      safety evaluations will be collected at study visits occurring at Weeks 1, 2, 3, 6, 9 and 12
      or at the time of early termination. Study medication will be discontinued at Week 12 and
      patients will return after 1 week for a post-treatment visit (Week 13).
    

Intervention name(s): tramadol HCl ER; celecoxib
Intervention type(s): Drug
Intervention MeSH terms: Celecoxib; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: osteoarthritis pain; knee; hip; extended release analgesia; opioid
Feasability Test of a Handset Device to Detect Levels of Sedation and Loss of Consciousness
Condition: Conscious Sedation
MeSH terms: Unconsciousness
Study type: Observational

Summary: 
      Sedation is often administered to relieve anxiety and discomfort during uncomfortable
      procedures in elderly patients. Patient control of sedation offers many potential benefits
      for patients and healthcare professionals, including improved safety and patient
      satisfaction. The investigators overall goal is to develop a patient controlled intravenous
      sedation system that is effective but very safe for the patient, and requires minimal
      supervision by a doctor or nurse. To fulfill these criteria, a sedation system should
      incorporate fail-safe safety mechanisms. A key safety-critical component is a method of
      objectively assessing the degree of sedation of the patient, and of preventing him from
      self-administering unsafe doses of the sedative drug. The investigators have designed a new
      sedation system that uses a measure of the speed of response of the patient to a defined
      non-noxious stimulus to determine whether or not it is safe to allow him to self-administer
      further levels of sedation. Before being able to execute a volunteer study in order to
      determine a rational selection of optimal threshold response time, a feasibility test on the
      handset device is required.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Twenty patients requiring anaesthesia for clinical surgical care. ASA physical status I, II
        or III
      
Keywords: Sedation
Effect of Memantine Versus Bupropion on Smoking Relapse in Nicotine-Dependent Individuals - 3
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      One of nicotine's effects on the body is at the level of the NMDA receptors in the brain.
      Memantine is a drug that also affects NMDA receptors, making it a candidate for the treatment
      of nicotine addiction. The purpose of this study is to evaluate the effectiveness of
      memantine using a laboratory model of smoking relapse in nicotine dependent volunteers.
      Investigators will compare the effects of memantine with bupropion, medication currently used
      to facilitate smoking cessation.
    

Detailed description: 
      Tobacco use is the leading preventable cause of death in the United States. Recent research
      on the effects of nicotine on the brain and behavior presents an opportunity to advance
      medication development. Neurotransmission at NMDA receptors in the brain is associated with
      learning and memory and has been linked to many of nicotine's effects on humans. It is
      possible that altering NMDA neurotransmission may be helpful in treating nicotine addiction.
      The goal of this study is to evaluate the effects of memantine, an NMDA receptor antagonist,
      using the laboratory model of smoking relapse in nicotine dependent volunteers. The effects
      of memantine used in combination with bupropion, a medication currently used to facilitate
      smoking cessation, will be compared to a placebo.

      This double-blind study will consist of three phases (placebo, bupropion, and memantine).
      Each phase will include 10 days of outpatient medication maintenance, followed by 5 days of
      inpatient testing. During the outpatient phase, study visits will occur every 2 to 3 days.
      During the first portion of inpatient stay, participants will not be permitted to smoke.
      During the second portion of inpatient stay, smoking reinstatement will be modeled, as
      participant will have opportunity to smoke. A variety of behavioral, subjective,
      physiological, and performance measures will be assessed throughout the study.
    

Intervention name(s): Memantine
Intervention type(s): Drug
Intervention MeSH terms: Memantine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: tobacco use