bioihbjkbjnl/mcl2 huggingface dataset:
A Safety and Tolerability Study of 10XB-101 Injections in Adult Subjects With Extra Fat Under the Chin ("Double Chin")
Condition: Submental Fat
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to find out more about an investigational drug,
      10XB-101, for people with fat under their chin which they would like to remove. The Sponsor
      of this study thinks there may be a chance this drug could be used to dissolve, or "melt"
      this fat away.
    


Intervention name(s): 10XB-101 Solution for Injection
Intervention type(s): Drug
Intervention description(s): Active test article
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Multi-center, open label, single ascending dose comparison.
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Long Term Calorie Restriction on Sphingomyelin and Amino Acids
Condition: Overweight; Obese
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 3

Summary: 
      The effect of weight loss with long-term low calorie diet (LCD) on plasma metabolites is
      unknown. The aim was to examine whether a LCD-induced weight reduction results in changes in
      the extended plasma metabolites.
    

Detailed description: 
      Overweight/obese subjects (25≤ BMI <33 kg/m2) aged 40 to 59 years consumed a LCD (an
      approximate 100 kcal/day calorie deficit) or a weight-maintenance diet (control) in a
      randomized, controlled design with 3-year intervention period.
    

Intervention name(s): LCD
Intervention type(s): Dietary Supplement
Intervention description(s): approximate 100 kcal/d caloric deficit
Other intervention name(s): weight loss diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: low calorie diet; BMI; sphingomyelin; L-leucine; L-phenylalanine
Patient Driven Recovery With Nalmefene and Coaching
Condition: Opioid-use Disorder; Harmful; Use, Alcohol
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      In collaboration with the First Pavlov State Medical University in St. Petersburg, Russia, we
      are proposing a pilot, open label, non-randomized clinical trial to evaluate the safety,
      feasibility, acceptability, and preliminary efficacy of treatment for alcohol and opioid use
      disorders combining Nalmefene and recovery coaching (educational and behaviorally oriented
      drug counseling). The proposed pilot study will also be used to further develop and refine
      the recovery coaching/counseling intervention and to train additional cadre of clinicians and
      researchers in St. Petersburg, Russia.
    

Detailed description: 
      The specific aims and hypotheses of the proposed study are as follows:

      Specific Aim 1: To evaluate the safety, feasibility, acceptability, and preliminary efficacy
      of treatment of alcohol and opioid use disorders combining Nalmefene and recovery coaching
      for rehabilitation of detoxified opioid dependent individuals in Russia.

      Specific Aim 2: To further develop and refine the recovery coaching/counseling intervention
      and to train additional cadre of clinicians and researchers in St. Petersburg, Russia.
    

Intervention name(s): Nalmefene
Intervention type(s): Drug
Intervention description(s): Educational and behaviorally oriented drug counseling
Other intervention name(s): Recovery coaching
Intervention MeSH terms: Nalmefene
Intervention model: Single Group Assignment
Intervention model description: Pilot, open label, non-randomized clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Quetiapine XR on Sleep in Patients With Major Depression, as Compared With Mirtazapine
Condition: Sleep
MeSH terms: Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine the effects of (a) quetiapine XR and (b) mirtazapine
      on sleep when given as an antidepressant (monotherapy). We hypothesize that (a) quetiapine XR
      has an immediate and lasting positive effect on sleep in depressed patients which does not
      differ from the impact of mirtazapine on sleep in this group of patients; (b) in the context
      of a secondary objective, we expect an antidepressant effect of quetiapine XR which is
      equivalent to that of mirtazapine.
    


Intervention name(s): quetiapine; mirtazapine
Intervention type(s): Drug; Drug
Intervention description(s): XR, 150-300mg; 30-45 mg
Intervention MeSH terms: Quetiapine Fumarate; Mirtazapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: antidepressant action; clinical psychopharmacology
Safety and Immunogenicity Dose-finding Study of Adjuvanted SCB-2020S Vaccine in Adults
Condition: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 study to assess the safety and immunogenicity of different formulations of
      the investigational adjuvanted recombinant SARS-CoV-2 trimeric S-protein (from beta variant)
      subunit vaccine (SCB-2020S vaccine), when administered as 2 dose vaccination series 21 days
      apart to adults ≥18 to ≤75 years of age.
    


Intervention name(s): Candidate vaccine, SCB-2020S; Candidate vaccine, SCB-2019; Squalene based adjuvant; CpG/alum adjuvant
Intervention type(s): Biological; Biological; Other; Other
Intervention description(s): a recombinant SARS-CoV-2 trimeric S-protein (from beta variant) subunit vaccine for COVID-19; a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; Squalene based adjuvant; CpG/alum adjuvant
Intervention MeSH terms: Aluminum Hydroxide; Vaccines; Aluminum sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Comparison of Psychological and Pharmacological Treatments for Pain Due to Temporomandibular Joint Disorder (TMD)
Condition: Temporomandibular Joint Disorders
MeSH terms: Joint Diseases; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether the combination of cognitive-behavioral
      treatment and nortriptyline are more effective than each treatment alone in reducing the pain
      and disability associated with TMD.
    

Detailed description: 
      This is a randomized, controlled trial evaluating pharmacological (nortriptyline vs. active
      placebo - benztropine) and psychological (cognitive-behavioral therapy vs. disease education)
      treatments for pain and disability due to temporomandibular joint disorder (TMD). Patients 18
      to 65 years old meeting RDC criteria for TMD and other eligibility criteria complete a 3-week
      baseline monitoring phase prior to randomization. Active treatment consists of weekly visits
      for 8 week, then maintenance treatment for 6 months. Outcome measures include pain, physical
      and psychosocial function and are assessed at post-treatment, 3-months, and 6-months
    

Intervention name(s): Nortriptyline Oral Capsule; Benztropine Oral Product; CBT; Disease MGT
Intervention type(s): Drug; Drug; Behavioral; Behavioral
Intervention description(s): Nortriptyline will be titrated up from 25 mg qhs to a maximum dose of 150 mg qhs based on treatment response and side effect profile.; Benztropine will be titrated up from .125 mg qhs to a maximum dose of .750 mg qhs based on treatment response and side effect profile.; Six in-person, individual sessions of cognitive-behavioral therapy for pain management include relaxation training, pain coping skills training, cognitive therapy for negative and dysfunctional thoughts, and diaries for monitoring relaxation, goals, and negative thinking.; Six in-person, individual sessions of temporomandibular joint disorder (TMD) disease management (MGT) that include information about the jaw and good oral habits, diet, sleep, and general stress management.
Intervention MeSH terms: Benztropine; Nortriptyline
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Novel Approach With Double Agent Artificial Oocyte Activation for Repeated Fertilization Failure Due to Combined Sperm and Oocyte Factor
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Novel approach for Oocyte fertilization failure for difficult cases not respond to
      traditional methods of assisted reproduction as intracytoplasmic sperm injection.
    

Detailed description: 
      In some cases undergoes assisted reproduction technique specially Intracytoplasmic sperm
      injection, in subgroup of patient they fail to fertilize or poorly fertilized, some authors
      recommend chemical activation for those group of patient with Ca ionophore but still with Ca
      ionophore there are some cases with total fertilization failure or low fertilization
      specially in those patient with 2 separate factors like teratozoospermia with poor quality
      Oocytes so the investigators decided to test the effect of double activation methods by using
      tow agents proven with life birth rate Ca ionophore and strontium chloride.

      We Do intracytoplasmic sperm injection and immediately activate oocyte with Ca Ionophore
      followed by strontium chloride activation and monitoring the embryogenesis until the
      blastocyst formation and pregnancy outcome in multicenter assessment.
    

Intervention name(s): Oocyte double chemical activation
Intervention type(s): Other
Intervention description(s): Oocyte double chemical activation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Study of Obinutuzumab to Evaluate Safety and Tolerability in Hypersensitized Adult Participants With End Stage Renal Disease Awaiting Transplantation
Condition: Kidney Failure, Chronic
MeSH terms: Kidney Failure, Chronic; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase Ib, open-label study of single and repeat doses of obinutuzumab administered
      as intravenous (IV) infusion in adults with end stage renal disease (ESRD). Participants will
      be enrolled into two cohorts receiving either one (Cohort 1) or two or more (Cohort 2)
      obinutuzumab infusions. Both cohorts will receive standard pretreatments to reduce the risk
      of infusion-related reactions (IRRs).

      Desensitization Period: In Cohort 1, participants will receive single dose obinutuzumab IV
      infusion on Day 1. Following review of Cohort 1 aggregated safety data up to 4 weeks post
      dose for the last participant of Cohort 1, Cohort 2 will be allowed to proceed. In Cohort 2,
      participants will receive obinutuzumab IV infusion on Days 1 and 15. Transplantation Period:
      Participants who qualify for transplantation and receive a compatible kidney offer after
      inclusion in Cohort 1 or Cohort 2 will receive two additional infusions (one at the time of
      transplantation and second at Week 24 post-transplantation) of obinutuzumab. Assessment of
      the safety and tolerability of the obinutuzumab regimen will be conducted at Week 24 of the
      desensitization phase and at Week 28 post-transplantation. All participants will be monitored
      for a minimum of 12 months following the last obinutuzumab infusion.
    


Intervention name(s): Obinutuzumab; Intravenous Immunoglobulin
Intervention type(s): Drug; Drug
Intervention description(s): Obinutuzumab 1000 milligrams (mg) IV infusion.; High dose (2 grams per kilogram [g/kg]) IVIG (maximum 140 grams).
Other intervention name(s): RO5072759
Intervention MeSH terms: Obinutuzumab; Immunoglobulins; Immunoglobulins, Intravenous; Antibodies; gamma-Globulins; Rho(D) Immune Globulin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Phase 3, Long-Term Safety Study of Intravenous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin
Condition: Chronic Renal Failure Requiring Hemodialysis
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine the long-term safety in treatment-emergent adverse
      events (TEAEs) of intravenous (IV) administration of Epoetin Hospira for maintenance of
      target hemoglobin (Hgb) levels in patients treated for anemia associated with chronic renal
      failure and on hemodialysis.
    


Intervention name(s): Epoetin Hospira
Intervention type(s): Biological
Intervention description(s): Intravenous (IV) injection
Other intervention name(s): ESA; Erythropoetin Stimulating Agent
Intervention MeSH terms: Epoetin Alfa
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic renal failure; hemodialysis
Study of the Effectiveness of Green Diode Laser Light on Body Shaping
Condition: Body Contouring
Study type: Interventional

Summary: 
      The purpose of this study is to determine if 532nm green diode laser light is effective in
      body contouring of the waist, hips and thighs.
    

Detailed description: 
      Weight loss and body contouring are large, constantly-growing fields of cosmetic surgery.
      However, while the demand for body shaping procedures is constantly on the rise, so is the
      demand for such procedures to be performed more quickly, simply and most importantly, less
      invasively; hence the growing popularity of non- to minimally-invasive cosmetic surgery
      procedures. In 2005, more than 7.5 million minimally-invasive cosmetic procedures were
      performed, a 35% increase from 2000.

      In recent years, Erchonia Corporation, a manufacturer of low level lasers, has developed a
      dual-diode laser that emits 532 nm and 635nm collimated line-generated beams to emulsify fat.
      In August, 2010, the Erchonia® ML Scanner (MLS) 635nm was cleared by FDA for use as a
      non-invasive dermatological aesthetic treatment for the reduction of circumference of hips,
      waist, and thighs. It was determined that the biochemical effect of the Erchonia® MLS
      stimulates the mitochondria of the adipocyte cells which in turn increases the production of
      ATP. The newly synthesized ATP triggers the up-regulation of cyclic adenosine monophosphate
      (cAMP). cAMP has been shown to stimulate cytoplasmic lipase, triggering the conversion of
      triglycerides into fatty acids and glycerol that can easily pass through the cell membrane.
      The transitory pore is evidence that the laser is allowing for the movement of fatty acids,
      glycerol, and triglycerides to pass across the membrane and into extra-cellular space.
      Through vasodilation of nearby blood vessels and arteries, oxidization of the triglycerides
      and fatty acids occurs within the extra-cellular space.

      This pilot study will apply the Erchonia® MLS employing 532 nm green diodes in lieu of 635 nm
      red diodes to compare the results to those attained using the 635 nm diodes. The Sponsor
      believes the use of 532 nm diodes may prove as effective as 635 nm diodes combined with a
      reduction in total procedure administration time from 40 to 30 minutes. It is the goal of
      this study to evaluate this hypothesis.
    

Intervention name(s): Erchonia GLS; Placebo laser
Intervention type(s): Device; Device
Intervention description(s): 532 nm green diode low level laser light device; Sham light output with no therapeutic benefit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Community Influences Transitions in Youth Health (CITY) Health II - Center for the Study of Community Health
Condition: Sexually Transmitted Diseases; HIV Infections
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      The purpose of this protocol is to develop and evaluate an HIV prevention Entertainment
      Education (EE) intervention aimed at reaching underserved, at-risk African Americans, aged
      18-25 years, living in disadvantaged urban neighborhoods in the Birmingham area.
    

Detailed description: 
      The goal of this 5 year project is to promote HIV testing and improve HIV-related risk
      behaviors (e.g. condom use, substance use before sex, regular Sexually Transmitted Infection
      (STI) testing) via population-sensitive and population-specific HIV prevention videos that
      are appealing, evidence-based, scalable, and sustainable to the target population. Formative
      research was conducted in Phase I (Year 1-2), to pre-test the questionnaire and gather
      in-depth data (via focus groups, intercept interviews, and individual structured interviews)
      to inform intervention development. Phase 2 of the project involved developing, delivering,
      and subsequently evaluating the efficacy of peer-driven EE HIV prevention messaging to
      broader social networks via a social media platform, with the platform contingent on
      formative data. An HIV education video series, "The Beat HIVe", was produced and served as
      intervention materials for the quasi-experimental research project. Respondent Driven
      Sampling (RDS) was used to access and use the social networks of high-risk youths as channel
      and agents for change. RDS is a recent innovative adaptation of chain-referral network
      sampling that provides peer-driven access to hard-to-reach subpopulations while reducing
      sampling biases associated with conventional snowball sampling.
    

Intervention name(s): Entertainment education; video
Intervention type(s): Behavioral; Other
Intervention description(s): video
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: two groups design with approximately equal allocation, but assignment based on respondent drive sampling
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: prevention and control; young adults; african americans; education entertainment; condom use
Multifocal vs Monofocal IOL in Congenital Cataract Surgery
Condition: Cataract Congenital
MeSH terms: Cataract
Study type: Observational

Summary: 
      The aim of this study is to evaluate long-term outcome after congenital cataract surgery
      comparing results achieved with multifocal and monofocal IOLs.
    

Detailed description: 
      PURPOSE: To assess the impact on visual development of multifocal versus monofocal
      intraocular lenses (IOLs) implantation in children following congenital cataract surgery.

      DESIGN: Retrospective interventional consecutive case series. METHODS: We reviewed the
      records of 56 eyes of 43 pediatric patients who underwent congenital cataract surgery with
      phacoaspiration and simultaneous implantation of IOL under one year of age. Corrected
      distance visual acuity (CDVA), refractive error and ocular motility disorders were evaluated
      after a follow-up greater than 4 years.
    

Intervention name(s): cataract surgery
Intervention type(s): Device
Intervention description(s): All patients underwent cataract surgery under 1 year of age (mean age 8 months, range 6-12) performed with the same surgical technique: two 1.2 mm clear corneal incision, continuous curvilinear capsulorhexis with a diameter of approximately 6.0 mm and intraocular lens implantation, posterior capsulotomy and anterior vitrectomy.
IOL power was calculated using Sanders-Retzlaff-Kraff (SRK)/II formula. Multifocal IOL implantated was Alcon AcrySof ReSTOR SN60D3, while the monofocal one was Alcon AcrySof SN60AT.
According to the Infant Aphakia treatment Study, the IOL power was calculated as a function of the child age17, with an undercorrection ranging from 4 to 6 D.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        We reviewed the records of 56 eyes of 43 pediatric patients who underwent congenital
        cataract surgery with phacoaspiration and simultaneous implantation of IOL under one year
        of age. All patients were directed to our hospital from primary care ophthalmologists or
        pediatricians
Pharmacokinetics of Tipranavir/Ritonavir and Its Metabolites in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to evaluate the pharmacokinetics of Tipranavir and its metabolites including excretion
      and mass balance of parent compound and radioactivity at steady-state; to isolate, identify
      and quantify major metabolites of tipranavir in plasma, urine and feces
    


Intervention name(s): 14C-Tipranavir; Tipranavir; Ritonavir
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ritonavir; Tipranavir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Retrospective Chart Review of Thirty Three Children Who Have Received Clinical Treatment With Either Romiplostim or Eltrombopag From 2009-2013
Condition: Immune Thrombocytopenia
MeSH terms: Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic
Study type: Observational

Summary: 
      This is a retrospective analysis of children (≤21years old) who received clinical treatment
      with either Romiplostim or Eltrombopag at 2 medical centers from 2009-2013. The children
      included in this study were from Weill Medical College of Cornell University, New York, New
      York and Children's Hospital Orange County, Orange, California
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients eligible for this study included both males and females ≤ 21 years old (actual
        range 19 months - 19 years) with persistent/chronic ITP lasting >6 months and were
        diagnosed according to the clinical practice guidelines from the American Society of
        Hematology.
      
Keywords: Immune Thrombocytopenia (ITP), Thrombopoietin (TPO) agents, children, romiplostim and eltrombopag
A Study To Evaluate PF-05175157 In Healthy Volunteers
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the pharmacodynamics of single oral doses of
      PF-05175157 in healthy volunteers
    


Intervention name(s): PF-05175157; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One single dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM.; One single dose of placebo will be administered as a powder-in-capsule in the fasting state in the AM.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1; Single Doses; Pharmacodynamics; Healthy Volunteers