bioihbjkbjnl/mcl2 huggingface dataset:
A High Density EEG Comparison of Sleep Patterns in Insomnia
Condition: Primary Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Observational

Summary: 
      Insomnia, defined as a subjective report of difficulty initiating sleep, maintaining sleep,
      and/or non-restorative sleep, leads to significant daytime dysfunction and increased health
      risks. A commonly held hypothesis is that insomnia is caused by a state of hyperarousal, but
      the neurobiological mechanisms of hyperarousal in insomnia are poorly understood, in part
      because of limitations in our ability to image the brain during normal human sleep with
      sufficient temporal resolution. Furthermore, the efficacy of insomnia treatment is judged by
      subjective report of the patient and demonstration of changes in sleep latency and/or sleep
      amount which are generally small in magnitude; there are currently no data to demonstrate
      that insomnia treatments correct any functional abnormalities in the sleep process that
      likely contribute to neurobehavioral abnormalities and health risks. The goals of the
      proposed study are to use high density EEG to define abnormalities in specific aspects of
      sleep in insomnia patients compared to healthy sleeping control subjects to define biomarkers
      that will both increase our understanding of the pathophysiology of insomnia as well as
      provide targets to assess treatments for insomnia.
    


Intervention name(s): Serial awakenings
Intervention type(s): Behavioral
Intervention description(s): The first study night will be a baseline sleep recording. The second night will consist of a series of awakenings (using auditory tones) and subsequent periods of falling back asleep in order to examine the cortical dynamics of hyperarousal or other dysfunction during these two critical sleep processes in insomnia.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Participants will be recruited from the community and from patients presenting at the
        Wisconsin Sleep and UW-Psychiatry clinics for insomnia.
      
Keywords: Insomnia; Primary insomnia; High density EEG; Polysomnography; Healthy sleeping controls
Skin Sensitization Potential of a New Nicotine Patch
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      An investigation on the skin sensitization potential of a new nicotine patch. Evaluation of
      the potential of a new nicotine transdermal patch to cause sensitization in the skin after
      repeated applications.
    

Detailed description: 
      Study on the skin sensitization potential of a new nicotine transdermal therapeutic system
      (TTS). A double blind, randomized, repeat patch test, single center phase I study.
    

Intervention name(s): Nicotine Patch; Placebo Patch
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg nicotine patch applied on the assigned marked sites on the lower back. Induction phase (21 days): left side, six treatment applications for 48 or 72 h. Challenge phase (five days): right side, one treatment application for 48 h.; Placebo patch applied on the assigned marked sites on the lower back. Induction phase (21 days): left side, six treatment applications for 48 or 72 h. Challenge phase (five days): right side, one treatment application for 48 h.
Other intervention name(s): Experimental Nicotine Patch; Placebo Control
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Pharmacodynamic and Safety of MEDITOXIN® in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine the pharmacodynamic and safety of MEDITOXIN® in healthy male
      volunteers.
    


Intervention name(s): Meditoxin; Botox
Intervention type(s): Drug; Drug
Intervention description(s): injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses; injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses
Intervention MeSH terms: Botulinum Toxins, Type A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Conservative Treatment of Proximal Humeral Fractures
Condition: Shoulder Fractures
MeSH terms: Fractures, Bone; Humeral Fractures; Shoulder Fractures
Study type: Interventional

Summary: 
      Optimal treatment of proximal humeral fractures is yet to be defined. Many of them can be
      treated non-operatively. The question remains on how long do we have to immobilize
      non-operatively treated proximal humeral fractures?
    

Detailed description: 
      There is still controversy on best treatment of proximal humeral fractures. While some
      authors propose surgical treatment other advocate for conservative treatment. Traditionally,
      fractures treated non-operatively undergo a 3-week period of immobilization followed by
      progressive rehabilitation program. Nevertheless, there is little evidence to support a
      3-week immobilization period. The purpose of this study is to bring evidence to support
      either a 1-week immobilization or 3-week immobilization period in non-operatively treated
      proximal humeral fractures.
    

Intervention name(s): conservative treatment
Intervention type(s): Procedure
Intervention description(s): immobilization on sling of the injured arm
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective randomized without restrictions
Masking: None (Open Label)
Primary purpose: Treatment
Lifestyle Intervention for Treating Systemic Hypertension in Primary Care Setting
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The Canadian hypertension education program recommends increased physical activity, adoption
      of the Dietary Approaches to Stop Hypertension (DASH) diet, and reduction in sodium and
      alcohol intake for treatment and prevention of hypertension. Objective: To describe patients
      participating in an interdisciplinary lifestyle intervention to reduce blood pressure in a
      family medicine primary care setting. Design: Descriptive study. Participants: The study aims
      to recruit 60 sedentary hypertensive patients to participate in a 6-month
      randomized-controlled trial. To be eligible, patients must be ≥18 years of age, sedentary
      (7-day measured steps/day and self-report), hypertensive (based on 24-h ambulatory blood
      pressure measurements [ABPM]), non-smoker, non-diabetic and without dyslipidemia.
      Intervention: Patients are recruited by health care professionals of the family medicine unit
      and are thereafter randomized to one of four intervention groups: 1) standard medical care
      (control), 2) improved diet (DASH diet), 3) physical activity, or 4) both improved diet and
      physical activity. Patients are evaluated (pre, mid and post intervention), monitored, and
      educated by the interdisciplinary health care team that includes a physician, a
      kinesiologist, a nutritionist and a nurse, depending on the intervention group. T-tests and
      descriptive statistics were used to analyse data. This study will document the efficacy of a
      primary care lifestyle intervention program on cardiometabolic and hypertension risk factors.
    


Intervention name(s): Lifestyle intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Hypertension; lifestyle; clinical trials; primary care setting
An Efficacy And Safety Study of CNTO 6785 In Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and safety of CNTO6785 in participants
      with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.
    

Detailed description: 
      This is a randomized (participants are assigned to treatment by chance), double-blind
      (participants and study personnel will not know which treatments are being given),
      placebo-controlled (a placebo appears identical to a study drug but has no active
      ingredients), multicenter study. The study will consist of 3 phases: a screening phase, a
      treatment phase, and a follow-up phase. Approximately 250 participants with active RA despite
      MTX therapy will be randomly assigned to receive placebo or CNTO 6785 during the double-blind
      treatment phase. The maximum period of active treatment will be 28 weeks. The maximum
      duration of study participation will be 44 weeks. Participant safety will be monitored
      throughout the study.
    

Intervention name(s): Placebo; CNTO 6785 200 mg; CNTO 6785 200 mg; CNTO 6785 100 mg; CNTO 6785 50 mg; CNTO 6785 15 mg; Methotrexate (MTX)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo subcutaneous injections (SC) every 4 weeks through Week 12; CNTO 6785 200 mg SC every 4 weeks from Week 16 through Week 28; CNTO 6785 200 mg SC every 4 weeks through Week 28; CNTO 6785 100 mg SC every 4 weeks through Week 28; CNTO 6785 50 mg SC every 4 weeks through Week 28; CNTO 6785 15 mg SC every 4 weeks through Week 28; MTX at the same stable dose through Week 32, that participants were receiving prior to screening.
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Active rheumatoid arthritis despite methotrexate therapy; CNTO 6785; Methotrexate
Oral Bioavailability of Bilastine
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the absolute bioavailability of an oral bilastine
      formulation (test drug) compared to the endovenous administration of an IV bilastine
      formulation (control drug) in healthy volunteers.
    

Detailed description: 
      Single centre, open label, cross-over, randomised, controlled, single dose study. The primary
      endpoint is the determination of plasma concentrations versus time (17 samples per subject at
      various time intervals after dosing) in order to assess the oral bioavailability of bilastine
      in healthy volunteers. Therefore the primary pharmacokinetic variable will be the area under
      the plasma concentration versus time curve from time zero to infinity (AUC 0-∞). Additionally
      the following pharmacokinetic variables will also be assessed: Cmax, AUC 0-t, tmax, Ae, Clr,
      t1/2. Additional objectives are to describe the safety and tolerability of a single
      administration of oral and endovenous bilastine in healthy volunteers.

      Twelve healthy volunteers will be included. Each volunteer will take in random order one
      single dose of 20 mg oral bilastine and 10 mg IV bilastine with a minimum washout period of
      14 days between them.

      Bilastine plasma concentrations will be measured using a liquid chromatography/mass mass
      spectrometry (LC/MS/MS) micro method
    

Intervention name(s): Bilastine; Bilastine
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg oral tablet; 10 mg endovenous bilastine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Oral bioavailability; absorption; AUC; Bioequivalence; Bioavailability study
Effects of Intranasal Administration of Oxytocin in Adults With Prader-Willi Syndrome
Condition: Prader-Willi Syndrome
MeSH terms: Prader-Willi Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigator thinks that the oxytocin (OT) can improve durably and significantly the
      behavior disorders and thus the socialization but also the satisfaction and could thus be an
      interesting therapeutic alternative for the patients presenting a Prader-Willi Syndrome
      (SPW). Although today several studies demonstrated the effects of the OT in various domains
      of the behavior, the investigator do not know either its specificity of action about the
      cerebral level, or its duration of action, or the optimal modalities of administration and in
      particular at patients SPW.
    


Intervention name(s): Oxytocin (OXT) continuous; Placebo; Placebo continuous; Oxytocin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administration of 24 IU of oxytocin daily during 28 days; Placebo daily during 28 days; Placebo administration the following 2 days after each OXT administration, during 28 days.; Administration of 24 IU of oxytocin every 3 days during 28 days.
Other intervention name(s): Syntocinon; Syntocinon
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: oxytocin; adults
High Dose Trial in COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study was to compare the efficacy and safety of 200 μg and 400
      μg of BEA 2180 BR to tiotropium 5 μg and placebo when each was delivered by the Respimat®
      Inhaler once daily for four weeks in patients with COPD.
    


Intervention name(s): BEA 2180 BR; tiotropium
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tiotropium Bromide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Efficacy Safety Study Comparing 2 Doses of NVP After Initiating Rifampin-containing TB Therapy
Condition: HIV Infections; Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      A 48 week, randomized, open-label, two arm study to compare the efficacy, safety and
      tolerability of HAART containing nevirapine 400 mg/day versus nevirapine 600 mg/day in HIV-1
      infected patients started at 2-6 weeks after initiating rifampicin containing
      antituberculosis therapy.
    

Detailed description: 
      Preliminary data from the HIVNAT PK laboratory indicate that out of 5/60 patients treated
      with nevirapine (200 mg bid) and rifampicin had sub-therapeutic nevirapine levels (<3.0 mg
      mg/L). In a control group of 38 patients using nevirapine without rifampicin there were no
      sub-therapeutic levels. A dose increase of nevirapine while patients who are receiving that
      rifampicin may be required. Both nevirapine and rifampicin are tepatotoxic agents as are
      other agents used in treatment of HIV or tuberculosis. Using a higher nevirapine may prevent
      the occurrence of sub-therapeutic nevirapine levels, but may also induce more liver toxicity.
      To address these issues, we designed a randomized prospective study to evaluate the safety,
      efficacy and pharmacokinetics of nevirapine 400 mg/day versus 600 mg/day with a two weeks
      lead-in 200 mg/day and 400 mg/day respectively, in TB-HIV co-infected patients who taking
      rifampicin and short-term efficacy and toxicity.
    

Intervention name(s): HAART containing nevirapine
Intervention type(s): Drug
Intervention description(s): Initially NVP 200 mg BID (400 mg per day) was compared to 400 mg BID and 200 mg OD NVP (600 mg per day). 400 mg/day versus 600 mg/day.
Intervention MeSH terms: Nevirapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV-TB; nevirapine based HAART with rifampin treated TB; Compare PK profile, efficacy, safety and tolerability of HAART containing nevirapine 400mg/day versus 600 mg/day in HIV/TB co-infected patients; Treatment Naive
Dose-response of Inhaled Formoterol Using Methacholine Challenge as a Bioassay
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to find out whether a difference between two doses of formoterol
      can be detected by methacholine challenge.
    

Detailed description: 
      During the screening visit, subjects'vital signs (heart rate, blood pressure and temperature)
      will be measured and they will perform standard spirometry. If the results of this test are
      70% of normal or greater, they will be examined by a physician, and blood (1 teaspoonful) and
      urine will be collected for routine laboratory tests (CBC and routine urinalysis). If they
      are a female, a pregnancy test will be performed.

      During the second visit, subjects will inhale 1 or 2 doses of formoterol, (Foradil Aerolizer
      12 mcg/capsule) a long-acting bronchodilator and 1 hour later, perform a methacholine test.

      At the end of the methacholine test, they will be given albuterol to reverse the effects of
      methacholine. On the third study day, they will repeat the second visit but with the opposite
      dose of Foradil.
    

Intervention name(s): formoterol; formoterol; Dry Powder Inhaler (Twisthaler)
Intervention type(s): Drug; Drug; Device
Intervention description(s): a single dose of 24 mcg of formoterol delivered by dry powder inhaler (Twisthaler); a single dose of 12 mcg of formoterol delivered by dry powder inhaler (Twisthaler); subjects inhaled deeply and forcefully and held their breath for 10 seconds for each dose
Intervention MeSH terms: Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: formoterol; methacholine challenge
Does Concomitant Use of Combined Oral Hormonal Steroids Stop Bleeding in Women Using Etonogestrel Implants (Implanon/Nexplanon®)?: A Randomized Controlled Study
Condition: Uterine Hemorrhage; Contraception
MeSH terms: Uterine Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      The specific aims are to determine if more women using Etonogestrel (ENG) contraceptive
      implants who report a bleeding-spotting episode of at least seven days will stop bleeding
      within 3 days of beginning a 14-day course of combined oral hormonal steroids, as compared to
      women receiving 14 days of placebo.
    

Detailed description: 
      The ENG contraceptive implant (Implanon/Nexplanon®), is a silicone- free, single rod
      subdermal contraceptive implant that contains 68 mg of etonogestrel, is approved for use for
      three years, and is one of the most effective forms of contraception available (1). ENG
      contraceptive implants are easily inserted and removed (1,2), offer quick return to fertility
      (2), are cost-effective and cost-saving (3,4) and offer non-contraceptive benefits such as
      improvement in pain for patients with complaints of dysmenorrhea (5).

      Hypothesis: Women using ENG contraceptive implants who report a bleeding-spotting episode of
      at least seven days will be more likely to stop bleeding within 3 days of beginning a 14-day
      course of combined oral hormonal steroids compared to women receiving 14 days of placebo.
    

Intervention name(s): Combined Oral Contraceptive Pill; Placebo Sugar Pill
Intervention type(s): Drug; Drug
Intervention description(s): 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill; Placebo Sugar Pill
Intervention MeSH terms: Contraceptive Agents; Contraceptives, Oral; Contraceptives, Oral, Combined
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Safety of Tranexamic Acid in Cytoreductive Surgery for Ovarian Cancer
Condition: Advanced Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional

Summary: 
      Tranexamic acid has been used in surgery for more than 30 years. It's effect on reducing
      bleeding and blood transfusing has been demonstrated.

      In our hospital, the amount of cytorsductive surgery for ovarian cancer is big. During the
      perioperation , bleeding probability is high, and the supply of blood products is limited. In
      order to reduce bleeding, we're planning to use tranexamic acid in the operations.

      In this experiment, we will observe the efficacy of tranexamic acid in cytoreductive surgery
      for ovarian cancer, find the best dosage which can reach the desired effect, and the possible
      side-effect.
    

Detailed description: 
      We performed a single blind, prospective, randomised control trial (RCT) . The patients
      randomised assigned to three groups. Low dose TXA, high dose TXA or a placebo of IV saline
      which will be infused prior to skin incision in patients undergoing elective cytorsductive
      surgery for ovarian cancer .

      Intraoperative blood loss will be estimated by the volume in the suction drains and by
      weighing the swabs. Postoperative blood loss will be estimated by the volume in the drains.

      The other secondary outcomes will be inclued perioperation transfusion volume, thromboembolic
      complications, ICU length of stay (LOS), hospital LOS, adverse thrombogenic events within 30
      days, 30-day all-cause readmission and so on.
    

Intervention name(s): Tranexamic Acid; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Tranexamic Acid will be given through central vein; normal saline will be given through central vein
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
A Study of Vilazodone in Pediatric Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the long-term safety and tolerability of vilazodone
      for the treatment of MDD in pediatric outpatients (7-17 years).
    


Intervention name(s): Vilazodone
Intervention type(s): Drug
Intervention description(s): Vilazodone tablets, once daily, oral administration
Other intervention name(s): Viibryd
Intervention MeSH terms: Vilazodone Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Efficacy, Safety And Toleration Of CP-866,087 In Pre-Menopausal Women With Female Sexual Arousal Disorder.
Condition: Sexual Dysfunction, Physiological
MeSH terms: Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 2

Summary: 
      CP-866,087 is a non-hormonal compound, acting on the central nervous system, which has been
      shown in animal models to restore sexual function.
    


Intervention name(s): CP-866,087; CP-866,087; CP-866,087; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablets for oral administration; Tablets for oral administration; Tablets for oral administration; Tablets for oral administration
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment