bioihbjkbjnl/mcl2 huggingface dataset:
Lesinurad and Allopurinol Combination Extension Study in Gout
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the serum uric acid lowering effects and safety of lesinurad in
      combination with allopurinol over a long-term timeframe.
    

Detailed description: 
      This is a Phase 3 extension study to assess the long-term efficacy and safety of lesinurad in
      combination with allopurinol in subjects who completed the double-blind treatment period in
      Studies RDEA594-301 and RDEA594-302.
    

Intervention name(s): Lesinurad; Lesinurad
Intervention type(s): Drug; Drug
Intervention description(s): Tablets, 200 mg QD; Tablets, 400 mg QD
Intervention MeSH terms: Lesinurad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gout
Safety of Lactobacillus Reuteri in Healthy Children Ages 2 to 5 Years in Peru
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study to assess the safety and tolerability of Lactobacillus reuteri (Lr)
      strain DSM 17938 in healthy children in Peru. It is a preliminary study in support of a
      clinical trial to assess safety and efficacy of L. reuteri for treatment of pediatric
      diarrhea in Peru.
    

Detailed description: 
      This is a phase I blinded randomized study of the safety and tolerability of Lactobacillus
      reuteri DSM 17938 given daily for a period of five consecutive days. Upon enrollment subjects
      will be randomized to one of two treatment groups in a ratio of treatment to placebo of 2:1.
      Subjects will be randomized to receive either:

      A. Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose,
      given once daily for a five-day treatment period that corresponds to a dose of the closely
      related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic.
      The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid
      found in the original BioGaia strain (L. reuteri ATCC 55730).

      B. Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing
      the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm,
      Sweden).

      In the first 30 subjects randomized, administration of each dose of the study preparation
      drops (A or B above) will be immediately followed by offering 2 ounces of flavored PediaSure
      ® (Abbott Laboratories) nutritional supplement to each child. The second 30 subjects enrolled
      will not be offered PediaSure ® after product administration. This format will also allow us
      to assess the impact of concurrent administration of a buffering non-lactose containing
      formula with prebiotic nutritional properties on intestinal colonization with L. reuteri by
      PCR.
    

Intervention name(s): Lactobacillus reuteri; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Probiotic; Placebo
Other intervention name(s): BioGaia Probiotic Drops
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Focus; safety
A Single Centre Study to Evaluate 3 Ophthalmic Formulations in Healthy Subjects
Condition: Glaucoma; Ocular Hypertension; Eye Disease
MeSH terms: Eye Diseases; Ocular Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      A Single Centre, Placebo-Controlled, Double-Masked, Sequential Designed Study to Evaluate 3
      Ophthalmic Formulations of AMA0076 in Healthy Subjects
    

Detailed description: 
      Each subject will receive the following treatments:

        -  Period 1: Formulation A (n = 14) or placebo (n = 7) twice daily for 7 days

        -  Period 2: Formulation B (n = 14) or placebo (n = 7) twice daily for 7 days

        -  Period 3: Formulation C (n = 14) or placebo (n = 7) twice daily for 7 days

      There will be a minimum washout of 7 days between each treatment period (last dose of
      previous period to first dose of subsequent period
    

Intervention name(s): AMA0076; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Repeat Topical Administration of BOS-475 in Healthy Subjects and Patients With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was conducted to evaluate the safety and tolerability of BOS-475 following single
      and repeat topical administration to healthy participants (Part A), and to evaluate the
      safety and tolerability of 42-day repeat topical administration of BOS-475 to participants
      with plaque psoriasis (Part B).
    

Detailed description: 
      In Part A, healthy participants were randomized to receive a single dose application of
      BOS-475 or vehicle cream. Following a washout period, participants received 7 days of
      repeated dosing with BOS-475 or vehicle cream on the back, followed by 7 days of repeated
      dosing of BOS-475 or vehicle cream over the facial area (excluding eye lids and areas around
      the mouth).

      In Part B, participants with mild to moderate stable plaque psoriasis affecting up to 15% of
      their body surface area were randomized to receive 6 weeks of topical treatment of BOS-475 or
      vehicle cream.
    

Intervention name(s): BOS-475; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): topical cream; topical cream
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psoriasis; BOS-475
Effectiveness of Prolonged Use of IUD/Implant for Contraception
Condition: Contraception
Study type: Interventional

Summary: 
      This study will evaluate LNG-IUD and Etonogestrel (ENG) Implant users who are willing to use
      their contraception beyond the end of the FDA-approved duration. ENG Implant users will also
      be offered to participate in an arm of the study that will randomize them to either keeping
      their implant in or having it removed and replaced with a new implant. Participants will be
      followed for up to three years.
    

Detailed description: 
      This prospective cohort study will evaluate 675 LNG-IUD users and 675 Etonogestrel (ENG)
      Implant users who are within 6 months of expiration or beyond the end of the FDA-approved
      duration. Participants will be contacted via telephone and either scheduled to enroll in
      person or be mailed the consent form before participation in the EPIC study. After the signed
      consent form is obtained, participants will also be asked to complete a brief telephone or
      in-person questionnaire on sociodemographic, medical and reproductive history, sexual and
      contraceptive history, history of unintended pregnancy and substance abuse. During the
      informed consent process, implant users will also be offered to participate in an arm of the
      study that will randomize them (if they consent) to either keeping their subdermal implant in
      or have it removed and replaced with a new subdermal implant. The randomized control trial
      subset allows us to compare effectiveness to that of a new implant.

      It also allows us to assess "other contraceptive use" (e.g. condom use) in both groups.

      Participants will also be asked if they are interested in providing a blood sample for
      analysis of etonogestrel assay levels at baseline enrollment and annually. If Follow-up phone
      interviews will occur every 6 months for 36 months beyond the expiration of their method. The
      investigators will attempt to validate all pregnancy outcomes with medical chart reviews.
    

Intervention name(s): Etonogestrel Implant
Intervention type(s): Device
Intervention description(s): Subdermal arm implant
Intervention MeSH terms: Etonogestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study will evaluate the use of the Etonogestrel Implant or hormonal intrauterine device (IUD) for contraception past the FDA approved duration. The Etonogestrel Implant is currently approved for 3 years of use, and the hormonal IUD is currently approved for 5 years.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Levonorgestrel intrauterine device (LNG IUD); Etonogestrel (ENG) Implant; Contraception
A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)
Condition: Multidrug Resistant Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Multidrug-Resistant
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to assess the safety, tolerability, pharmacokinetics, and
      efficacy of long-term (6-month) treatment with delamanid plus an optimized background regimen
      (OBR) of other anti-tuberculosis drugs in pediatric participants who completed Study
      242-12-232 (NCT01856634).
    

Detailed description: 
      This study will assess the safety, tolerability, pharmacokinetics, and efficacy of delamanid
      plus an optimized background regimen in pediatric participants with MDR-TB over a 6-month
      treatment period. This long-term study, an extension of Study 242-12-232, will be conducted
      in participants who have completed Study 242-12-232.
    

Intervention name(s): Delamanid; Delamanid Pediatric Formulation (DPF); Optimized Background Regimen (OBR)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants received adult formulation delamanid as per regimen specified in the arm description. Morning dose of the delamanid BID regimen was given within 30 minutes after the start of a standard breakfast meal. The evening dose of the BID dose regimen was given 10 hours post morning dose and within 30 minutes after the start of a standard dinner meal.; Participants received delamanid as an extemporaneous suspension using the delamanid pediatric dispersible tablet formulation. Morning dose of the delamanid BID/once daily (QD) regimen was given within 30 minutes after the start of a standard breakfast meal. The evening dose of the BID dose regimen was given 10 hours post morning dose and within 30 minutes after the start of a standard meal.; Selection and administration of the treatment medications (i.e. OBRs) was based on Search Results Web result with site links
World Health Organization (WHO's) Guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines. Study Investigator could change OBR for a participant based on his/her tolerability and drug susceptibility testing (DST) results.
Other intervention name(s): OPC-67683
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tuberculosis; Tuberculosis, Multidrug-Resistant; Mycobacterium Infections; Actinomycetes Infections; Gram-Positive Infections; Bacterial Infections; Pediatric
The Tolerance, Pharmacokinetics of Jaktinib in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, double-blinding, dose-escalated phase 1 trial to evaluate the tolerance and
      fasting/postprandial pharmacokinetics of jaktinib.
    

Detailed description: 
      The study is a randomized, double-blind phase 1 trial including 3 independent parts: single
      ascending dose(SAD) part,multiple ascending dose(MAD) part and postprandial pharmacokinetics
      part. SAD and MAD are dose-escalated tolerant study designed 8 cohorts and 5 cohorts in SAD
      and MAD respectively. The aims of the study as below:

        1. Evaluating the safety and tolerance of Jaktinib in healthy volunteers.

        2. Evaluating the fasting pharmacokinetic parameters of Jaktinib in healthy volunteers.

        3. Evaluating the postprandial pharmacokinetic parameters of jaktinib in healthy
           volunteers.

        4. Analysis the metabolites of Jaktinib
    

Intervention name(s): Jaktinib Dihydrochloride Monohydrate; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Active Substance; Placebo
Other intervention name(s): Jaktinib; PLA
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: SAD: 8 cohorts, 8 subjects take jaktinib and 2 subjects take placebo;
MAD: 5 cohorts, 8 subjects take jaktinib and 2 subjects take placebo;
Postprandial Phamocokinetics:12 subjects, crossover designing
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: JAK2 inhibitor; Tolerance; Pharmacokinetics; Dose-escalated
Call-2-Health: Preventing Type II Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      It is estimated that 30 million U.S. adults will have type 2 diabetes by 2050. Contributing
      to this national trend is the obesity epidemic. Three randomized trials have demonstrated
      that intensive behavioral interventions can prevent or delay the onset of diabetes. The
      purpose of this pilot study is to inform a future randomized, controlled Phase III trial of a
      population-based, telephonic, exercise and weight loss intervention to translate the findings
      of the Diabetes Prevention Program into practice. The telephonic intervention will be
      compared to usual care (30 participants in each group). The investigators will deliver the
      intervention in 12 weekly, 20-minute calls, with four subsequent maintenance calls, for a
      total of 16 calls over 24 weeks. Study outcomes will be measured at baseline and at 12 and 24
      weeks.

      For this planning grant the investigators do not have an overall hypothesis. The
      investigators' goal is to develop and test whether it is possible to do exercise and weight
      loss
    


Intervention name(s): Telephonic intervention to prevent Diabetes Mellitus, Type 2
Intervention type(s): Behavioral
Intervention description(s): Participants assigned to the intervention group received a total of 16 phone calls from the study interventionist over 24 weeks. The first 12 weeks was the intervention phase and calls were made weekly. The second 12 weeks was the maintenance phase and calls were made every 3 weeks. After 24 weeks, the investigators continued to follow this group for 52 weeks post-randomization, allowing half of the group to continue to receive monthly maintenance calls while the other half received no further calls. The study interventionist used behavior modification techniques to encourage intervention group participants to adopt healthy eating and exercise habits so that improvement might be seen in fasting glucose, glycated hemoglobin (HbA1c), weight, and waist/hip measurements.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: Intervention; Telephone; Diabetes; Prevention
Effects of Acute Dietary Changes on Estimates of Body Composition
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The present study sought to investigate the effects of acute dietary changes on estimates of
      body composition. Specifically, the impact of an acute high-carbohydrate diet (9 g/kg body
      weight of carbohydrate) and an acute very low-carbohydrate diet (1 - 1.5 g/kg body weight of
      carbohydrate) were examined.
    


Intervention name(s): High-carbohydrate diet; Low-carbohydrate diet
Intervention type(s): Other; Other
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Body Composition
Baclofen Effects on Marijuana Dependence
Condition: Marijuana Dependence
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      Studies show that certain reminders of drug use such as the sight of someone using marijuana,
      pictures of blunts, particular moments throughout the day, prompt marijuana users to smoke
      marijuana. We are measuring the brain and behavioral responses of marijuana dependent
      individuals to these reminders (cues) We will examine brain responses during cue exposure and
      determine whether these responses are associated with treatment outcome.

      We are testing the hypothesis that the medication baclofen reduces brain responses during
      marijuana cue exposure and/or craving in marijuana dependent individuals. Baclofen is
      FDA-approved for other uses, but not for the treatment of marijuana dependence. Functional
      magnetic resonance imaging (fMRI) will be used to measure the brain's response to marijuana
      cues. fMRI is a painless technique that takes special pictures of the brain (or other parts
      of your body). It does not involve radiation or injections.

      Eligible participants will have a 50% chance of receiving placebo (sugar pill) and a 50%
      chance of receiving baclofen. Neither the participant nor study personnel will know whether
      participants are receiving baclofen or placebo. Participants will also receive twice weekly
      psychosocial treatment with a certified clinician. Twelve weeks of treatment will be followed
      by a 12 week follow up.
    


Intervention name(s): Baclofen; Psychosocial; Placebo
Intervention type(s): Drug; Behavioral; Drug
Other intervention name(s): Kemstro; Lioresal; Liofen; Gablofen; Beklo; Sugar pill
Intervention MeSH terms: Baclofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Marijuana; Addiction; fMRI; Baclofen; Treatment
Safety and Efficacy of XP200 Radiofrequency Treatment of Wrinkles
Condition: Periorbital Wrinkles
Study type: Interventional

Summary: 
      To evaluate the wrinkle-reducing effects of 3.25-MHz radiofrequency (RF) energy delivered in
      4 weekly applications to human periorbital skin area by grating pre- and 90-days post
      treatment photographs on the Fitzpatrick Wrinkle Severity Scale (FWSS) by three blinded
      evaluators.
    


Intervention name(s): RF XP200; XP200 RF device
Intervention type(s): Device; Device
Intervention description(s): Four weekly non-invasive periorbital wrinkles treatment with RF XP200 device; 4 RF treatments of periorbital region on one side of the face
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: wrinkles; rhytids; periorbital
Study of Relative Bioavailability of Mobic Manufactured in China in Comparison With Mobic Manufactured in Germany in Chinese Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to compare the pharmacokinetic parameters of the 7.5 mg Mobic
      tablet manufactured in china in comparison with 7.5 mg tablets manufactured in Germany
    


Intervention name(s): Mobic, China, 7.5 mg; Mobic, Germany, 7.5 mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Meloxicam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exteriorized Versus In Situ Uterine Repair at Cesarean Delivery
Condition: Vomiting; Nausea; Pain; Hypotension; Tachycardia
MeSH terms: Hypotension; Tachycardia; Nausea; Vomiting
Study type: Interventional

Summary: 
      This study was undertaken to compare the two techniques (exteriorized vs in situ) of uterine
      repair with respect to patient comfort, hemodynamic changes, surgical time and blood loss, in
      patients undergoing elective CD under a strictly standardized spinal anesthetic. We
      hypothesized that in situ uterine repair would be more comfortable for the patients.
    

Detailed description: 
      Uterine repair during Cesarean delivery can be done either by exteriorizing the uterus and
      replacing it into the abdominal cavity after the completion of a double layer closure, or by
      suturing it in situ. Exteriorization of the uterus has been shown to decrease blood loss
      during Cesarean delivery when compared to in situ repair. However, at the same time, it is
      thought to be uncomfortable for the patient with respect to intraoperative nausea, vomiting
      and pain. Intraoperative nausea and vomiting in patients who receive regional anaesthesia for
      Cesarean section is a complex multifactorial problem arising from anesthetic and
      non-anesthetic causes. Additionally, it can influence hemodynamic stability.

      The study was a prospective, randomized and single blinded study. It compared the effects of
      exteriorization of the uterus and in-situ repair during Cesarean delivery with respect to
      patient's comfort, hemodynamic changes, uterine contractility and blood loss in patients
      under spinal anesthesia. All low risk patients undergoing elective C-delivery under spinal
      anesthesia were considered for this study.

      Spinal anesthesia was performed in the sitting position with 10-12 mg of 0.75% hyperbaric
      bupivacaine, mixed with 100 mcg of preservative free morphine and 10 mcg of fentanyl. Any
      drop in blood pressure was treated with 100 mg of phenylephrine titrated to maintain systolic
      blood pressure within 10% of the baseline values throughout the procedure. Oxytocin was used
      judiciously, in aliquots of 0.5 IU. Obstetricians were asked to allow assisted spontaneous
      delivery of placenta rather than manual extraction. During surgery, patient's complaints of
      nausea, vomiting, pain or any discomfort were recorded.
    

Intervention name(s): Spinal Anesthesia
Intervention type(s): Drug
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Cesarean delivery; Spinal anesthesia; Nausea; Vomiting; Pain
Study of Intravenous NRX-1074 in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of NRX-1074 following a
      single intravenous dose in subjects with major depressive disorder.
    

Detailed description: 
      NRX-1074 is a N-methyl-D-aspartate (NMDA) receptor functional partial agonist with efficacy
      in animal models of affective disorders including major depressive disorder. The purpose of
      this study is to evaluate efficacy and safety of NRX-1074 at dose levels that are predicted
      by comparison of human and animal pharmacokinetics to be efficacious.
    

Intervention name(s): NRX-1074 1 mg; Placebo; NRX-1074 5 mg; NRX-1074 10 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single intravenous administration of 1 mg into arm on Day 0; Single intravenous injection into the arm on Day 0; Single intravenous injection of 5 mg into the arm on Day 0; Single intravenous injection of 10 mg into the arm on Day 0
Other intervention name(s): NRX-1074 IV single dose; NRX-1074 IV single dose; NRX-1074 IV single dose; NRX-1074 IV single dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NRX-1074; NMDA Receptor Modulator; Major Depressive Disorder; Glycine site modulator