bioihbjkbjnl/mcl2 huggingface dataset:
Effect of VI-0521 (Qsymia®) on Glomerular Filtration Rate (GFR) in Overweight or Obese Healthy Subjects
Condition: Obesity
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is measure the effect of VI-0521 on kidney function.
      Specifically, glomerular filtration rate (GFR) will be measured at baseline, after 4 weeks of
      study treatment, and after an additional 4 weeks of off-treatment recovery.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, single-site study in healthy
      overweight or obese male and female volunteers. Oral VI-0521 (combination of phentermine and
      topiramate [PHEN/TPM] extended-release capsule) will be administered daily as follows:

        -  Days 1-3: PHEN/TPM 3.75 mg /23 mg

        -  Days 4-6: PHEN/TPM 7.5 mg /46 mg

        -  Days 7-9: PHEN/TPM 11.25 mg /69 mg

        -  Days 10-28: PHEN/TPM 15 mg /92 mg

      A single dose of Iohexol (a non-radioactive iodine-containing contrast agent) will be
      administered intravenously on three separate occasions.

      The study will include a total of 50 healthy subjects (40 active and 10 placebo), all of whom
      will have overnight stays on 3 separate occasions.

      Total study duration is approximately 10 weeks (2 weeks screening, 4 weeks study treatment, 4
      weeks post treatment follow up).
    

Intervention name(s): Qsymia; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): VI-0521; Phentermine and Topiramate ER (Extended Release); Sugar Pill
Intervention MeSH terms: Topiramate; Phentermine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Renal function; Glomerular Filtration Rate; Kidney function; Qsymia; Iohexol; Serum Creatinine; Creatinine clearance; Renal Clearance; VI-0521; Healthy volunteers
The Safety and Effectiveness of the Essure (Model ESS505) Device to Prevent Pregnancy in Women
Condition: Contraception
Study type: Interventional

Summary: 
      To evaluate the safety and long-term (approximately one year) effectiveness of the Essure
      System for Permanent Birth Control ESS505 device in preventing pregnancy.
    

Detailed description: 
      This study has previously been posted by Conceptus, Inc. After acquiring Conceptus, Inc.,
      Bayer is now the sponsor of the trial.
    

Intervention name(s): ESS505 (BAY1454033)
Intervention type(s): Device
Intervention description(s): Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 in the proximal portion of the fallopian tubes using a transvaginal approach. Subsequent transvaginal ultrasound (TVU) or hysterosalpingogram (HSG) was performed approximately ≤ 3 hours and 90 days following insert placement.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Birth control; Permanent Contraception
Aripiprazole for the Treatment of Mania in Children and Adolescents With Bipolar Disorder
Condition: Bipolar Disorder; Mania
MeSH terms: Mania; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-labeled study of Aripiprazole, testing its efficacy in the treatment of mania
      in children and adolescents with Bipolar I, Bipolar II and Bipolar Spectrum Disorder over 8
      weeks. This is an exploratory, pilot study, seeking to determine whether Aripiprazole is
      efficacious and well tolerated in the treatment of youth with pediatric bipolar and bipolar
      spectrum disorder. The study results will be used to generate hypotheses for a larger
      randomized controlled clinical trial with explicit hypotheses and sufficient statistical
      power.
    

Detailed description: 
      Initial clinical evidence suggests that atypical neuroleptics may play a unique therapeutic
      role in the management of pediatric bipolar disorder. Aripiprazole is a novel neuroleptic
      recently approved by the FDA for the treatment of schizophrenia, and it has a unique
      pharmacological profile believed to be fundamentally different from other available
      antipsychotics. Many previous studies have reported increased efficacy of Aripiprazole
      compared to placebo. Unfortunately, Aripiprazole has not been investigated in children and
      adolescents, and as such, safety and efficacy has not been established for these populations.

      This is an exploratory, pilot study, seeking to determine whether Aripiprazole is efficacious
      and well tolerated in the treatment of youth with pediatric bipolar and bipolar spectrum
      disorder. The study results, gathered from an 8 week open-label treatment period and
      subsequent 10 month extension period, will be used to generate hypotheses for a larger
      randomized controlled clinical trial with explicit hypotheses and sufficient statistical
      power.
    

Intervention name(s): aripiprazole (Abilify)
Intervention type(s): Drug
Intervention MeSH terms: Aripiprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mania; Abilify; children; bipolar disorder
Clinical Trial to Assess the Effects of Dairy on Insulin Sensitivity and β-Cell Function
Condition: Diabetes
MeSH terms: Insulin Resistance; Hypersensitivity
Study type: Interventional

Summary: 
      The aim of this trial is to evaluate the effects of dairy product consumption on insulin
      sensitivity and pancreatic β-cell function in men and women at risk for the development of
      type 2 diabetes mellitus (T2DM) who habitually consume beverages high in sugar (non-diet
      sodas and fruit juice cocktails).
    


Intervention name(s): Low-fat dairy; Sugar-sweetened beverages
Intervention type(s): Other; Other
Intervention description(s): 2 servings/d of 2% non-flavored, unsweetened milk + 1 serving/d sweetened low-fat yogurt; 2 servings/d of non-diet soda + 1 serving/d of non-dairy pudding
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Insulin sensitivity
Study of Roxadustat (FG-4592) in Participants With End-Stage Renal Disease Receiving Maintenance Hemodialysis
Condition: End Stage Renal Disease; Anemia
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Anemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the efficacy and safety of roxadustat in
      participants with end-stage renal disease (ESRD) on maintenance hemodialysis (HD) therapy,
      previously treated with intravenous (IV) epoetin alfa.
    

Detailed description: 
      Dose ranging study with consecutive cohorts in two participant populations: participants
      normally responding to current anemia treatment (epoetin alfa) ("normoresponders":
      participants with baseline epoetin alfa dose at study entry 75 to 450 international units
      [IU]/kilograms [kg]/week) and participants not responding well to current treatment
      ("hyporesponders": participants with maintenance epoetin alfa dose above 450 IU/kg/week).
      Normoresponders are randomized to study drug roxadustat or epoetin alfa at a ratio of 3:1;
      hyporesponders are randomized to study drug roxadustat or epoetin alfa or placebo at a ratio
      of 2:1:1. The study objectives are to demonstrate that roxadustat is effective in maintaining
      hemoglobin (Hb) levels when converting from epoetin alfa and to establish optimum starting
      doses and dose adjustment regimens for Hb maintenance.
    

Intervention name(s): Roxadustat; Epoetin Alfa; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Roxadustat will be administered per dose and schedule specified in the arms.; Epoetin Alfa will be administered per dose and schedule specified in the arms.; Placebo matching to roxadustat will be administered per schedule specified in the arm.
Other intervention name(s): FG-4592
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Kidney; End Stage Renal Disease; ESRD; Chronic Kidney Disease; CKD; Renal; Anemia; Oral anemia treatment; Hemoglobin levels; Blood count; Erythropoietin; Hemodialysis; Normoresponder; Hyporesponder
L-Threonic Acid Magnesium Salt (L-TAMS) in ADHD
Condition: Attention Deficit/Hyperactivity Disorder; ADHD
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a 12-week, open-label pilot study to test the effects of MMFS-201-301 on
      cognition and function in adults with ADHD. Subjects may enter the trial on a stable dose of
      medication for ADHD, and MMFS-201-301 will be given. Subjects who do not enter on a stable
      dose of ADHD medication will receive MMFS-201-301 alone.
    


Intervention name(s): L-Threonic Acid Magnesium Salt (L-TAMS)
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Attention Deficit/Hyperactivity Disorder; ADHD; Attention Deficit Disorder; ADD; Magnesium
The Effects of Use of Mirror Image on Radiation Exposure During Fluoroscopically Guided Transforaminal Epidural Injection
Condition: Lumbar Radiculopathy Due to Spinal Nerve Compression
MeSH terms: Radiculopathy
Study type: Interventional

Summary: 
      Lumbar Transforaminal Epidural Injection is helpful for the treatment of lumbosacral
      radicular pain.

      Tunnel view technique is the basis of X-ray assisted intervention. In this technique, it is
      necessary to handle the block needle in order to adjust the direction of needle to the tunnel
      view toward target. If a mirror is used during needle handling, overall procedure time and
      radiation exposure can be reduced.
    

Detailed description: 
      1. A planned Fluoroscopically Guided Lumbar Transforaminal Epidural Injection should be
           performed after receiving the informed consent of the patient.

        2. This study is single-blind because it is not possible to blind the practitioner
           performing the injection.

        3. Subjects were randomly assigned to the normal method group (group A) and the mirror use
           group (group B) by a random random number table, and the possibilities for belonging to
           any group were all the same and can not be artificially controlled by researchers.

        4. After the procedure, a resident who does not know of this study records the radiation
           exposure time displayed on the monitor and the overall procedure time
    

Intervention name(s): Fluoroscopically Guided Lumbar Transforaminal Epidural Injections; conventional manner
Intervention type(s): Procedure; Procedure
Intervention description(s): Lay the subject down on the stomach and hold the pillow on the stomach. The skin of the injection area is sterilized by aseptic method and covered with aseptic pouch. After confirming the level of he vertebrae around the C-arm and aligning the anteroposterior view of the endplate of the vertebral body, rotate the C-arm 20~30 degrees diagonally in the direction to be performed. After confirming the best Scotty dog view, confirm the final target point at 6 o'clock directly below the pedicle. At this position, the skin point is marked on the skin. And then both groups proceed in parallel with the beam direction of the transducer with the tunnel view technique until the needle reaches the back of the vertebral body at the level of the spinal nerve roots. At this time group A uses a mirror and group B dose not. The final reach of the target point (ideal depth) is confirmed through the anterior and posterior views and lateral views.; A portable mirror is located at the side of surgical table and used in this procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: normal method group (group A) mirror use group (group B)
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: epidural steroid injection; radiation exposure; mirror
Effects of Sitagliptin on Postprandial Lipemia in Men With Type 2 Diabetes
Condition: Diabetes Mellitus; Postprandial Lipemia
MeSH terms: Diabetes Mellitus; Hyperlipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      Sitagliptin is a potent and selective inhibitor of dipeptidyl peptidase IV (DPP-4), and has
      been shown to reduce fasting and postprandial glucose levels in patients with type 2 diabetes
      mainly through incretin hormone-mediated improvements in islet function. Although clinical
      studies to date indicate that fasting lipid levels are minimally affected by DPP-4 inhibitor
      treatment, animal studies suggested that DPP-4 inhibition reduce intestinal triglyceride (TG)
      absorption and apolipoprotein production and increased chylomicron catabolism. Therefore, the
      present study was designed to examine the effects of sitagliptin on postprandial lipemia in
      patients with type 2 diabetes. A possible reduction in postprandial atherogenic
      triglyceride-rich lipoproteins (TRL) levels by sitagliptin would add to therapeutic utility
      of this DPP-4 inhibitor and suggest the potential to reduce cardiovascular risk in patients
      with type 2 diabetes.
    


Intervention name(s): Sitagliptin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sitagliptin 100 mg/d for 6 weeks; Placebo for 6 weeks
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes mellitus; Postprandial; Hyperlipidemia; Atherosclerosis
Use of Misoprostol in Case of Insertion Failure of Intrauterine Contraceptives
Condition: Cervical Stenosis
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the usefulnes sof misoprostol versus placebo (in a double-blind placebo controlled
      randomized clinical trial)to facilitate the insertion of copper-IUD and the
      levonorgestrel-releasing intrauterine system (LNG-IUS) in cases of failure due to cervical
      stenosis in either nulligravidas and parous women. Additionally to evaluate the side-effects
      of the misoprostol. The hypothesis is that misoprostol may be better than placebo.
    

Detailed description: 
      Women attended at the Family Planning clinic of the University of Campinas who requested the
      insertion of a copper-IUD or an LNG-IUS and who failed in the attempt due to cervical
      stenosis will be randomized in two groups (1:1). The study group will receive two doses of
      misoprostol (200mcg each tablet) vaginal 12 and 4 hours prior insertion and the control group
      will receive placebo in the same schedule. The sample will be 50 women in each group. After
      24 hours of the insertion failure the women will return to the clinic and a new attempt of
      insertion will be done. At this time we will evaluate if the insertion was able to do or not.
      The data will be analyzing with χ2 test for independent samples. After that a multiple
      logistic analysis will be perform to evaluate the associated variables with the result
      (failure or successful) insertion. The level of significance will be established at P<.005.
    

Intervention name(s): Misoprostol
Intervention type(s): Drug
Intervention description(s): The study group will receive two doses of misoprostol (200mcg each tablet) vaginal 12 and 4 hours prior insertion. After 24 hours of the insertion failure the women will return to the clinic and a new attempt of insertion will be done. At this time we will evaluate if the insertion was able to do or not.
Other intervention name(s): PROSTOKOS
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: intrauterine device; insertion failure
A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to demonstrate the bioequivalence (BE) of a single
      subcutaneous (SC) dose of lecanemab via vial and AI in healthy participants.
    


Intervention name(s): Lecanemab; Lecanemab
Intervention type(s): Drug; Drug
Intervention description(s): Lecanemab will be administered subcutaneously using a vial and syringe.; Lecanemab will be administered subcutaneously using AI.
Other intervention name(s): BAN2401; BAN2401
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: BAN2401; Lecanemab
Hysterectomy and Levonorgestrel Releasing Intrauterine System (LNG-IUS) in the Treatment of Menorrhagia
Condition: Menorrhagia
MeSH terms: Menorrhagia
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomised study including 236 women referred for essential menorrhagia to five university
      hospitals in Finland was conducted to compare the cost-effectiveness and the quality of life
      issues in the treatment of menorrhagia.Participants were randomly assigned to treatment with
      LNG-IUS (n=119), or hysterectomy (n=117), and were monitored for ten years. The primary
      outcome measures were health related quality of life (HRQoL), other measures of psychosocial
      well-being (anxiety, depression, sexual functioning), and costs.
    

Detailed description: 
      A randomized VUOKKO trial was conducted between 1994-2008 to study hysterectomy and LNG-IUS
      in the treatment of menorrhagia.Overall, 236 women aged 35 to 49 years who were menstruating,
      had completed their family size, and were eligible for both treatments were randomized to
      either receive a LNG-IUS (n=119) or undergo hysterectomy (n=117). The follow-up visits took
      place six months and 12 months after the treatment, and again five and ten years after the
      randomization. The primary outcome measures were health related quality of life (HRQoL),
      other measures of psychosocial well-being (anxiety, depression, sexual functioning), and
      costs. The amount of menstrual blood loss was objectively measured before treatment and after
      one and five years. The one year the results were published in 2001 (Lancet 2001;357:273) and
      the five year results in 2004 (JAMA 2004; 291:1456).
    

Intervention name(s): LNG-IUS; Hysterectomy
Intervention type(s): Drug; Procedure
Intervention description(s): LNG-IUS releasing 25 microg of levonorgestrel; operation
Other intervention name(s): Mirena; Removal of uterus by laparoscopy, vaginally or abdominally
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: randomized controlled trial; menorrhagia; LNG-IUS; hysterectomy
A Comparison of Acute Psychobiological Responses to Laboratory Stress Tests
Condition: Stress, Physiological; Stress, Psychological
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      The Mannheim Multicomponent Stress Test (MMST) is a validated laboratory stress test that
      combines cognitive, emotional, acoustic and motivational stress components. However the
      utility of the MMST as a viable alternative to the more commonly used Trier social stress
      test (TSST) to elicit HPA reactivity remains unclear as meaningful increases in saliva
      cortisol (> 2.5 nmol/l) have been shown to occur in <50% of participants yet the TSST
      typically elicits meaningful increases in saliva cortisol in >70% of participants; likely as
      a consequence of the greater social evaluative component in the TSST.

      Using a randomised between groups design, this study aims to compare psychobiological
      responses to the MMST and TSST.
    


Intervention name(s): MMST; TSST
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants randomised to the MMST group will complete the computer based paced auditory serial addition task (PASAT-C) in the presence of one observer and is informed that incorrect answers result in reduced monetary compensation. Simultaneously, the participant is exposed to emotionally evocative images and white noise via headphones; Participants randomly assigned to the TSST condition will be exposed to a traditional TSST protocol. The TSST consists of a preparation phase (5 min), followed by a mock job interview and a mental arithmetic task (5 min each) in front of a panel consisting of two observers and a video recording device.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Between subjects design to compare psychobiological responses in participants randomised to either the MMST or the TSST. Stratified block randomisation will be used to evenly distribute participants to the MMS or the TSST based upon sex (male or female) and trait anxiety (low STAI-T score <40 or high STAI-T score ≥40).
Masking: Single (Participant)
Primary purpose: Basic Science