bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ISIS 443139 in Participants With Early Manifest Huntington's Disease
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study tested the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple
      ascending doses of ISIS 443139 administered intrathecally to adult participants with early
      manifest Huntington's Disease.
    


Intervention name(s): ISIS 443139 10 mg; ISIS 443139 30 mg; ISIS 443139 60 mg; ISIS 443139 90 mg; ISIS 443139 120 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Other
Intervention description(s): ISIS 443139, 10 mg, was administered by intrathecal injection, on Study Days 1, 29, 57, and 85.; ISIS 443139, 30 mg, was administered by intrathecal injection, on Study Days 1, 29, 57, and 85.; ISIS 443139, 60 mg, was administered by intrathecal injection, on Study Days 1, 29, 57, and 85.; ISIS 443139, 90 mg, was administered by intrathecal injection, on Study Days 1, 29, 57, and 85.; ISIS 443139, 120 mg, was administered by intrathecal injection, on Study Days 1, 29, 57, and 85.; Placebo was administered by intrathecal injection, on Study Days 1, 29, 57, and 85.
Other intervention name(s): IONIS HTTRx; IONIS HTTRx; IONIS HTTRx; IONIS HTTRx; IONIS HTTRx
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Huntington's Disease; HTTRx; Early Manifest Huntington's Disease
A Two-dose Primary Vaccination Study of a Tetravalent Dengue Virus Purified Inactivated Vaccine vs. Placebo in Healthy Adults
Condition: Dengue Fever
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to afford a safety and immunogenicity assessment of three Tetravalent
      Dengue Virus-Purified Inactivated Vaccine(TDENV-PIV) vaccine candidates.
    

Detailed description: 
      The study is designed to afford a safety and immunogenicity assessment of three Tetravalent
      Dengue Virus-Purified Inactivated Vaccine(TDENV-PIV) vaccine candidates, each formulated with
      a different adjuvant: either aluminum hydroxide, AS01E or AS03B (adjuvants used in Glaxo
      Smith Kline (GSK) Biologicals' hepatitis B candidate vaccine, malaria candidate vaccine and
      pandemic flu vaccine, respectively). Each vaccine candidate will contain 1 µg of purified
      virus antigen per each of the four DENV types. Additionally, the study will evaluate an alum
      adjuvanted TDENV-PIV vaccine candidate containing 4 µg of purified virus antigen per each of
      the four DENV types. The control group will receive a saline placebo. All experimental
      vaccinations will be administered according to a 2-dose schedule, 28 days apart.
    

Intervention name(s): 4 µg TDENV-PIV with Alum adjuvant; 1 µg TDENV-PIV with AS03B1 adjuvant; Phosphate buffered saline; 1 µg TDENV-PIV with Alum adjuvant; 1 µg TDENV-PIV with AS01E1 adjuvant
Intervention type(s): Biological; Biological; Other; Biological; Biological
Intervention MeSH terms: Aluminum Hydroxide; Aluminum sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dengue; Dengue fever; Dengue Hemorrhagic Fever; Flavivirus
Do Adolescents and Adults Differ in Their Acute Response to Cannabis?
Condition: Cannabis; Cannabis Intoxication; Cannabis Use; Cannabis Dependence; Marijuana; THC; CBD; Adolescent Development
MeSH terms: Marijuana Abuse
Study type: Interventional

Summary: 
      The acute effects of cannabis may differ between adolescents and adults. Furthermore, these
      effects may be tempered by the presence of cannabidiol. This double-blind,
      placebo-controlled, crossover experiment investigates the acute effects of cannabis (with and
      without cannabidiol) on subjective effects, behavioural responses and neural functioning in
      16-17 year-olds and 26-29 year-olds who regularly use cannabis (0.5-3 days per week).
    


Intervention name(s): Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD); Cannabis with THC without CBD; Placebo cannabis
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) - inhaled and vaporised cannabis flower; Cannabis with THC without CBD - inhaled and vaporised cannabis flower; Placebo cannabis, without THC and without CBD - inhaled and vaporised
Intervention MeSH terms: Dronabinol; Cannabidiol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double-blind, placebo-controlled, crossover experiment with drug condition block randomised and stratified by age-group and gender, such that drug order is counterbalanced.
There are two groups: adolescents (16-17 years old) and adults (26-29 years old). These groups are matched on current cannabis use frequency.
There are three drug conditions: (1) cannabis with delta-9-tetrahydrocannabinol (THC) and without cannabidiol (CBD), (2) cannabis with THC but without CBD, and (3) placebo cannabis without THC and without CBD.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Cannabis; Marijuana; THC; CBD; Adolescence; fMRI; Cognition; Subjective effects; Psychotomimetic effects
Efficacy of the Mckenzie Method in Patients With Chronic Non-Specific Low Back Pain
Condition: Non-specific Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to assess the efficacy of the McKenzie method in patients with
      chronic non-specific low back.
    

Detailed description: 
      One hundred and forty-eight patients will be randomly allocated to two treatment groups:
      McKenzie method or Placebo (detuned ultrasound and short wave therapy) for 5 weeks (total of
      10 sessions of 30 minutes each).

      The clinical outcomes will be obtained at the completion of treatment (5 weeks) and at 3, 6,
      and 12 months after randomization. The data will be collected by a blinded assessor. The
      statistical analysis will follow the intention-to-treat principles and the between-group
      differences will be calculated by constructing mixed linear models.
    

Intervention name(s): Placebo; McKenzie method
Intervention type(s): Other; Other
Intervention description(s): The patients allocated to the Placebo group will be treated with detuned pulsed ultrasound therapy for 5 minutes and detuned short wave diathermy in pulsed mode for 25 minutes. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week).; The patients of the McKenzie group will be treated according to the principles of the method and the choice of therapeutic intervention will be guided by the physical examination findings and classification. Patients will also receive written instructions from the Treat Your Own Back book and will be asked to perform home exercises based on the principles of McKenzie method. The description of the exercises that will be prescribed in this study are already published elsewhere. Compliance with home exercises will be monitored by means of a daily-log that the patient will fill in at home and bring to the therapist at each subsequent session. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week).
Other intervention name(s): Placebo effect; Nocebo effect; McKenzie
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low Back Pain; Mechanical Low Back Pain; Low Back Ache; Low Backache; Lower Back Pain; Lumbago
A Study to Test How a New Long-acting Insulin (Insulin Icodec) Works in the Body of People With Liver Disease
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Participants will receive one insulin icodec dose, which will be administered in the morning
      of the day of dosing.

      The study will last for about 8 weeks. Participants will have 8 visits with the study doctor
      in the clinical research unit.

      Insulin icodec will be injected into a skin fold with a small needle (subcutaneous
      application) using a pen injector prefilled with a volume of 3 mL (about a spoonful).

      Participants must not participate if they meet certain conditions called exclusion criteria,
      such as an age of below 18 years or above 70 years, if participants are over- or underweight,
      using certain medicines, or have serious health conditions (other than impaired liver
      function ).

      Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the
      study period.
    


Intervention name(s): Insulin icodec
Intervention type(s): Drug
Intervention description(s): Insulin icodec will be investigated in participants with impaired liver function and subjects with normal liver function. Administered as a single dose subcutaneously (under the skin) The study will last for about 8 weeks.
Intervention MeSH terms: Insulin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sildenafil Citrate in Frozen Embryo Transfer
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2

Summary: 
      Comparison between usage of Sildenafil citrate with estradiol valerate or estradiol valerate
      alone in endometrial preparation and outcome of frozen-thawed embryo transfer cycles.
    


Intervention name(s): Sildenafil citrate; estradiol valerate
Intervention type(s): Drug; Drug
Other intervention name(s): Viagra
Intervention MeSH terms: Sildenafil Citrate; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: IVF
48 Weeks, Study to Evaluate Overall Safety and Tolerability of Co-administration of Tesofensine and Metoprolol in Subjects With Hypothalamic Injury-induced Obesity (HIO)
Condition: Hypothalamic Injury-induced Obesity (HIO)
MeSH terms: Obesity; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      Double-blind, randomized, placebo-controlled, single- center study followed by an open-label
      extension period.

      • The study will have two parts:

        -  Part 1: 24 weeks double-blind treatment (DB), followed by

        -  Part 2: 24 weeks open-label extension (OLE) - all subjects still participating at the
           end of Part 1 will be given an option to continue for additional 24 weeks on the active
           drug if evaluated eligible by the Investigator
    

Detailed description: 
      Part 1 - the double-blind (DB) part: The active medication arm will be given
      co-administration of 0.5 mg tesofensine/50 mg metoprolol daily for 24 weeks. The placebo arm
      will receive matching placebo tablets.

      Part 2 - the open-label extension (OLE) part: All active participants at the end of the
      double-blind part will be given the active medication 0.5 mg tesofensine/50 mg metoprolol
      daily for 24 weeks.
    

Intervention name(s): Tesofensine/Metoprolol; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): During Part 1 subjects will be randomized to treatment with co-administration of 0.5 mg tesofensine/50mg metoprolol (active medication); During Part 1 subjects will be randomized to matching placebo tesofensine and placebo metoprolol
Intervention MeSH terms: Metoprolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Electroacupuncture and Thread Embedded Acupuncture With Dietary Intervention in Obese Patients
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effectiveness between electroacupuncture
      treatment with dietary intervention and thread embedded acupuncture with dietary intervention
      in reducing body weight, waist circumference, and leptin level in obese patients.
    

Detailed description: 
      The purpose of this study is to describe reducement in body weight, waist circumference, and
      leptin level in obese patients with dietary intervention and electroacupuncture or dietary
      intervention with thread embedded acupuncture. It is also to analyze mean differences of body
      weight, waist circumference, and leptin level in obese patients between the two
      interventions. The results of the study expected to be used as an operating standard
      procedure for obese patients.
    

Intervention name(s): Electroacupuncture; Thread embedded acupuncture
Intervention type(s): Procedure; Procedure
Intervention description(s): Stimulating acupoints using electric stimulator; Stimulating acupoints using thread embedded
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There are two groups of intervention. The first group is getting electroacupuncture treatment and the second group is getting thread embedded acupuncture treatment.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: electroacupuncture; thread embedded acupuncture; obese; dietary intervention
Midazolam Efficacy for Sedating Preschoolers Undergoing Dental Treatment
Condition: Early Childhood Caries
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluation of oral midazolam to improve children's behavior and reduces the stress and
      anxiety during dental treatment
    

Detailed description: 
      This study was initially planned to investigate three paediatric sedation regimens that also
      included the following arms:

        -  oral midazolam + oral ketamine + inhaled sevoflurane

        -  oral midazolam + oral ketamine + inhaled oxygen So, the former protocol found in the PRS
           registry was called PedSed-III and included the aforementioned arms.

      However, there was a long delay in fund release from the funding agency (State of Goias
      Research Foundation - FAPEG). Although the grant was approved in the beginning of 2013,
      resources were released in November 2013.

      We could not wait for funding release because this study was part of the MS dissertation of
      the principal investigator that was supposed to be concluded in the first semester of 2013.
      Then we decided to develop a less robust study, including only two arms: oral midazolam
      versus oral placebo. The other variables of the study did not change. We finished this
      two-arms study and have the final results for that comparison.
    

Intervention name(s): Midazolam; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Dormire: Midazolam oral solution 2 mg/mL Sedative was administered with a syringe by the anaesthesiologist; Magistral formula prepared to match Dormire color and consistency, without active ingredients Placebo was administered the same way as midazolam
Other intervention name(s): Brand: Dormire (Cristalia, Sao Paulo, Brazil); Magistral formula
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: conscious sedation; stress psychological; dental care for children; child behavior; saliva
A Study to Investigate the Safety and Effect of Food on the Pharmacokinetics of YM178 in Healthy Volunteers
Condition: Healthy Volunteer; Pharmacokinetics of YM178
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate safety of YM178 and the effect of food intake on the
      pharmacokinetics of YM178 in healthy adult subjects.
    

Detailed description: 
      A open-label, randomized, crossover study to assess the effect of food on the
      pharmacokinetics of single dose of YM178 administered under fasted and fed conditions.
    

Intervention name(s): YM178
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): mirabegron
Intervention MeSH terms: Mirabegron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Overactive Bladder; Urinary incontinence; YM178; mirabegron; Food effect
Oral vs Rectal Admin of Naproxen for Post-Vag Perineal Pain Control
Condition: Post-Vaginal Delivery Perineal Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to determine whether the route of administration of
      naproxen (either by mouth or rectally) influences post-vaginal delivery perineal pain
      control.
    

Detailed description: 
      Postpartum perineal pain is common after vaginal delivery. Naproxen suppositories have been
      shown to be effective at reducing postpartum perineal pain. To date, no studies have
      investigated the efficacy of oral naproxen for perineal pain control. Currently, rectal
      naproxen is used postpartum because of an assumption that there is a "local effect" compared
      to oral administration. However, this effect has never been documented in the literature.

      Principles of pharmacology dictate that the least invasive route of drug administration
      should be used when two or more routes are equally effective. If oral and rectal naproxen are
      equally efficacious at controlling post-vaginal delivery perineal pain, then current practice
      would be challenged.

      The primary objective of this study is to determine whether the route of administration of
      naproxen influences post-vaginal delivery perineal pain control. Pain scores will be measured
      using a visual analog scale. The secondary outcome measures are three-fold: patient
      preference of route of administration, medication adverse effects, and additional requests
      for analgesia. The working hypothesis is that there is no difference in pain control between
      oral and rectal administration and that patients will prefer the oral route.
    

Intervention name(s): Naproxen
Intervention type(s): Drug
Intervention description(s): Treatment allocation either A Naproxen PO + placebo PR or B Placebo PO + Naproxen PR
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clomiphene Stair-Step Protocol for Ovulation Induction in Women With Polycystic Ovarian Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The objective of our study is to evaluate the efficacy of the clomiphene stair-step protocol
      to induce ovulation in women with polycystic ovarian syndrome (PCOS) compared to traditional
      protocol.

      Methods:This was a randomized controlled clinical trial at the Fertility clinic of Al sadder
      teaching hospital at Al- Najaf city, Iraq . It included 140 women who met all of the
      inclusion criteria, they were divided into two groups; 65 patients for the stair step
      protocol and 75 patients for the traditional protocol.
    

Detailed description: 
      Overall study design This was a randomized clinical trial using toss a coin as randomization
      technique carried out on subfertile women attending the Fertility Clinic of AL Sadder
      Teaching Hospital at Al- Najaf city, Iraq from May 2010 till May 2011. 170 infertile women
      were selected at that time for study participation after their written consent.

      Participant, recruitment and randomization:

      The diagnostic criteria adopted for PCOS was according to Rotterdam ESHRE/ASRM sponsored PCOS
      consensus workshop group, 2004 based on the presence of two of the following three criteria:
      i.e. Oligo- and/or anovulation, hyperandrogenism clinical and/or biochemical, Polycystic
      ovaries, an ovary with 12 or more follicles measuring 2-9 mm indiameter and increased ovarian
      volume (>10 cm3) on transvaginal ultrasound(1) .
    

Intervention name(s): clomiphene
Intervention type(s): Drug
Intervention description(s): For both protocols follow up of the follicular growth has been made by frequent tvUSS monitoring, which have the advantage of providing direct information about the size and number of follicle and measurement of endometrial thickness during clomiphene medication.
Other intervention name(s): clomid
Intervention MeSH terms: Clomiphene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Polycystic Ovarian Syndrome stair step traditional protocol
Screening Evaluation for Studies of Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      This research is being done to study mechanisms of progression of COPD and to develop
      treatments for it. The investigators are doing the present study to identify people age 40
      and older with mild to moderate COPD who will qualify for such studies to include in a
      database. The study will include establishing a screening evaluation or characterization of
      the following two studies:

        -  Emphysema Progression in COPD- Losartan's Effects on Airway Parameters - NA_00009980

        -  Sleep-Related Physiology and Inflammation in Chronic Obstructive Pulmonary Disease -
           NA_00001771
    

Detailed description: 
      This is a program to recruit and screen participants for clinical trials or more detailed
      observational studies of COPD. There are no interventions or comparative results to be
      published from this study.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Both Male and Female 40 years and older
      
Biospecimen description: 
      blood
    
Keywords: Chronic Obstructive Pulmonary disease (COPD)