bioihbjkbjnl/mcl2 huggingface dataset:
Carbetocin Versus Oxytocin and Hemodynamic Effects
Condition: Effects of; Anesthesia, in Pregnancy
Study type: Interventional
Phase: Phase 4

Summary: 
      A randomized double-blind trial of oxytocin 5 u, carbetocin 100 µg and placebo with
      hemodynamic response as a primary outcome measure.
    

Detailed description: 
      Healthy pregnant women sheduled for elective cesarean section. Invasive hemodynmaic
      monitoring with LiDCO Plus.
    

Intervention name(s): carbetocin 100 µg; oxytocin 5 u; placebo (NaCl)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Hemodynamic effect of; Hemodynamic effect of; Hemodynamic effect of
Other intervention name(s): Pabal, injection; Syntocinon, injection; Saline, injection
Intervention MeSH terms: Oxytocin; Carbetocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cesarean delivery; blood pressure; cardiac output
TLIP Block Versus Modified TLIP Block for Posterior Decompression and Stabilization Surgery
Condition: Analgesia; Surgical Procedure, Unspecified
Study type: Interventional

Summary: 
      This study aimed to compare the analgesia effectivity of TLIP and modified TLIP block in
      Posterior Lumbar Decompression and Stabilization Surgery Perioperatively.
    

Detailed description: 
      This study aimed to compare the analgesia effectivity of TLIP and modified TLIP block in
      Posterior Lumbar Decompression and Stabilization Surgery. Intraoperatively, total fentanyl
      consumption, hemodynamic, and mean qNox Score was recorded. And Postoperatively, the patient
      was given the PCA, and total morphine consumption was assessed.
    

Intervention name(s): Thoracolumbar Interfascial Plane block; Modified Thorcolumbar Interfascial Plane block
Intervention type(s): Procedure; Procedure
Intervention description(s): Interfascial block done by injection between m. multifidus and m. longissimus; Injection of local anesthetics between m. longissimus and m. illiocostalis
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Erector Spinae Plane Block; opioid consumption; numerical rating scale; Interleukin 10; Interleukin 6; Thoracolumbal Interfascial Plane Block
Comparative Pharmacokinetics of a Compounded 6-mercaptopurine Liquid Formulation Preparation and Tablets
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Observational

Summary: 
      The purpose of this study is to compare the pharmacokinetics of a routinely used compounded
      liquid formulation of 6-mercaptopurine (6-MP) with commercially available tablets in patients
      who are receiving treatment with 6-MP as part of their clinical treatment for acute
      lymphoblastic leukemia (ALL).
    


Intervention name(s): 6-Mercaptopurine
Intervention type(s): Drug
Intervention description(s): 75 mg/m2/dose/day
Other intervention name(s): 6-MP
Intervention MeSH terms: Mercaptopurine
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients ages 4-17 years of age who are receiving maintenance chemotherapy treatment for
        ALL with 6-MP will be included
      
Biospecimen description: 
      whole blood, plasma
    
Keywords: ALL; acute lymphoblastic leukemia; 6-Mercaptopurine; Pediatric
A Phase III, Randomized, Double-Blind, Multicentre Study to Evaluate the Safety and Efficacy of 1592U89 in Patients With AIDS Dementia Complex
Condition: AIDS Dementia Complex; HIV Infections
MeSH terms: AIDS Dementia Complex; Dementia
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the benefit of adding 1592U89 to current antiretroviral therapies for AIDS
      dementia complex and to assess the safety and tolerance of the treatment regimens.
    

Detailed description: 
      Patients must be on stable antiretroviral treatment for at least 6 weeks prior to study entry
      and will then be stratified depending on whether their regimen contains zidovudine (ZDV).
      Each stratum will be randomized separately to receive 1592U89 or placebo for 12 weeks. For
      the subsequent 40 weeks, open-label 1592U89 will be offered.
    

Intervention name(s): Abacavir sulfate
Intervention type(s): Drug
Intervention MeSH terms: Abacavir
Masking: Double
Primary purpose: Treatment
Keywords: Acquired Immunodeficiency Syndrome; AIDS Dementia Complex; Antiviral Agents; abacavir
Study of RC18 Administered Subcutaneously to Subjects With Systemic Lupus Erythematosus(SLE)
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to initially access the safety and effectivity of RC18 combined
      with standard treatment and Placebo combined with standard therapy in subjects with Moderate
      to severe SLE, Besides ,to provide dose basis for follow-up clinical trials.
    


Intervention name(s): Placebo plus standard therapy; RC18 80 mg plus standard therapy; RC18 160 mg plus standard therapy; RC18 240 mg plus standard therapy
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator therapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,leflunomide, Tacrolimus ,ciclosporin ); Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator herapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,leflunomide, Tacrolimus ,ciclosporin ); Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator herapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,leflunomide, Tacrolimus ,ciclosporin ); Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator therapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,leflunomide, Tacrolimus ,ciclosporin )
Other intervention name(s): Standard therapy; Standard therapy; Standard therapy; Standard therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety, Tolerability, and Efficacy of MTP-131 for the Treatment of Mitochondrial Myopathy
Condition: Mitochondrial Myopathy
MeSH terms: Muscular Diseases; Mitochondrial Myopathies; Mitochondrial Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Phase 1/2, multi-center, randomized, double-blind, multiple ascending dose,
      placebo-controlled study that enrolled 36 subjects with mitochondrial myopathy associated
      with genetically confirmed mitochondrial disease to evaluate the safety, tolerability,
      pharmacokinetics (PK), and preliminary efficacy of MTP-131 in this patient population.
    

Detailed description: 
      This multi-center, randomized, double-blind, placebo-controlled study enrolled 36 subjects
      into 3 cohorts of 12 subjects each to evaluate treatment with 3 ascending doses of
      intravenous elamipretide (0.01, 0.10, and 0.25 mg/kg/hr infused for 2 hours). After each
      cohort, a Safety Monitoring Board (SMB) determined if dose escalation to the next higher dose
      of elamipretide was warranted. Each cohort went through 3 distinct periods: Screening,
      Treatment, and Follow-up.

      The Screening Period started with informed consent and may have lasted up to 40 days. During
      this period, screening procedures to determine subject eligibility for the study occurred,
      including confirmation of disease, which incorporated a committee review of the
      investigator-submitted diagnosis and genetic results. The Treatment Period began on Day 1
      (Visit 2) and lasted for 5 days (until Day 5 [Visit 6]). Within each cohort, 9 subjects were
      randomized to active drug and 3 subjects were randomized to placebo on Day 1 and subjects
      received treatment once a day for 5 consecutive days. Safety, tolerability, and efficacy
      measures were performed at pre-specified times. The Follow-up Period began at the time of
      discharge on Day 5. Subjects returned to the study center for the Follow-up Visit on Day 7
      (+1 day).
    

Intervention name(s): elamipretide (low dose); elamipretide (intermediate dose); elamipretide (high dose); Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): elamipretide (0.01 mg/kg/hr) administered as single day intravenous infusion over 2 hours for 5 days; elamipretide (0.10 mg/kg/hr) administered as single day intravenous infusion over 2 hours for 5 days; elamipretide (0.25 mg/kg/hr) administered as single day intravenous infusion over 2 hours for 5 days; placebo (at each dose cohort) administered as single day intravenous infusion over 2 hours for 5 days
Other intervention name(s): MTP-131; MTP-131; MTP-131
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mitochondrial Myopathy; Primary Mitochondrial Disease; Bendavia™; elamipretide
Evaluating the Efficacy of a Gum Health Formulation on Teeth Whitening in Patients With Gingivitis and Periodontitis
Condition: Tooth Discoloration; Periodontal Diseases
MeSH terms: Gingivitis; Periodontitis; Periodontal Diseases; Tooth Discoloration
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of a novel gum health formulation, when
      used in an intra-oral device or on a toothbrush, for teeth whitening and clinical
      improvements in periodontal diseases.
    

Detailed description: 
      Over half of the American population suffers from some form of periodontal disease, while
      millions of Americans are electing for teeth whitening procedures every year. The study is
      designed to assess the efficacy of a novel gum health formulation on teeth whitening in the
      context of gingival inflammation. Further, the study aims to assess the efficacy of the novel
      gum health formulation as an adjunct to the current standard of care in the treatment of
      gingivitis and periodontitis, depending on the severity of disease. As the dental
      professional community is whitening teeth in an environment of gingival inflammation, a
      single product that whitens teeth and controls inflammation is a novel treatment approach and
      highly desirable among patients and consumers.
    

Intervention name(s): Gum health formulation in intra-oral device; Gum health formulation on toothbrush
Intervention type(s): Other; Other
Intervention description(s): The intervention is a gum health formulation for periodontal disease care and teeth whitening to be used within an accelerating intra-oral device.; The intervention is a gum health formulation for periodontal care and teeth whitening to be used on a toothbrush alongside standard toothpaste.
Other intervention name(s): ECO Balance; GLO Science intra-oral accelerating device; ECO Balance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Periodontal diseases; Periodontitis; Gingivitis; Teeth Whitening; Dental Plaque Index; Periodontal Index; Teeth Whitening Agents; Tooth Discoloration; Mean Probing Depth; Pocket Depth
Summer Weight and Environmental Assessment Trial
Condition: Childhood Obesity
MeSH terms: Pediatric Obesity
Study type: Observational

Summary: 
      The consequences of childhood obesity are devastating, affecting the physical and mental
      health of children. Disadvantaged school-age children are at risk for unhealthy gains in BMI
      during the summer months and there is a dearth of information regarding the causal health
      behaviors and environmental factors. The overall objective of this application is to provide
      an in depth examination of key dietary and physical activity behaviors as well as the food,
      physical activity, and social environments of low-income, racial/ethnic school-age children.
      To achieve this goal, an observational study utilizing a multi-state prospective cohort
      design will be conducted with the goal of examining the weight gain trajectory among a
      racially and ethnically diverse convenience sample of disadvantaged school-age children who
      routinely attend structured programming during the summer months and those who don't
      participate in structured programming. In addition, a subset of these children will be
      evaluated to learn their daily health behaviors, as well as their food, physical activity,
      and social environments during the summer. Identification of determinants of program
      participation and factors that may enhance the beneficial effects of program participation
      will also occur. A social ecological framework approach will guide the research. This study
      can be expected to have a significant positive impact by providing information on the factors
      that protect disadvantaged children from unhealthy weight gain during the summer which can be
      used by stakeholders at the local, state, and federal level to reform current policy that
      will increase child participation in health promoting programming during the summer window of
      risk.
    


Intervention name(s): n/a - observational study
Intervention type(s): Other
Intervention description(s): n/a - observational study
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Racially and ethnically diverse convenience sample of disadvantaged school-age children
Transplantation of Bone Marrow Derived Mesenchymal Stem Cells in Affected Knee Osteoarthritis by Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Osteoarthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Osteoarthritis of the knee is one of the most common causes of disability among elderly.
      Arthritis rheumatoid is an autoimmune disease which causes multi articular arthritis, such as
      knee osteoarthritis. As the disease progresses the cartilage become frustrated, surrounding
      bone react to become thicker and inflammation occurs in subchondral bone seen in T2-weighted
      MRI as increase in signal density. Patients are treated initially by pain management. In
      patients who don't response to first line treatment invasive treatment like total knee
      replacement is done. The investigators designed this clinical study with the aim of
      evaluating therapeutic effects of intra-articular injection of bone marrow mesenchymal stem
      cells (BM-MSCs) in 60 patients with knee osteoarthritis.
    

Detailed description: 
      In this study all eligible patients were randomly allocated into two study groups by a
      permuted block randomization method: group A (control group) received only routine medical
      therapies and placebo injected into there knees.. Group B received mesenchymal stem cells in
      addition of routine medical therapy.

      Patients were categorized according to the following stimulation protocols:

      To assess the outcomes, after mesenchymal stem cells transplantation at months 1,3,6 and 12
      we will examine the patients by: WOMAC questioners, DAS28 scoring , radiographies assessments
      and biochemical analysis with laboratory tests.
    

Intervention name(s): mesenchymal cell transplantation; placebo
Intervention type(s): Biological; Biological
Intervention description(s): Mesenchymal stem cell transplantation in patients with rheumatoid arthritis for resurfacing of articular cartilage of knee due to osteoarthritis.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mesenchymal stem cells; osteoarthritis; arthritis rheumatoid
Pharmacokinetic and Safety Study of Cenicriviroc and Acid Reducing Agents When Dosed Alone or in Combination
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, Single and Multiple-Dose, Open-Label Study in Healthy Subjects to Assess
      the Effect of the Acid Reducing Agents, Omeprazole and Famotidine, on the PK of CVC
    


Intervention name(s): Cenicriviroc; Omeprazole; Famotidine
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Cenicriviroc 150 mg; Omeprazole 20 mg; Omeprazole 40 mg; Famotidine 40 mg
Intervention MeSH terms: Cenicriviroc; Omeprazole; Famotidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Utility of Trimethoprim-sulfamethoxazole Use in Skin Abscess Management
Condition: Skin Diseases, Infectious
MeSH terms: Communicable Diseases; Infections; Abscess; Skin Diseases, Infectious; Skin Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if antibiotics are required in the management of
      skin abscess following incision and drainage.
    

Detailed description: 
      This is a double-blind, randomized controlled trial at an urban pediatric emergency
      department. Sample size (162) was based on a threshold equivalence of 7% (α = 0.05, power =
      80%). Inclusion criteria were: non-toxic, immunocompetent, 3 months to 18 years old,
      English-speaking patients with clinical or ultrasound identified skin abscesses who were not
      on antibiotics. Patients were block randomized to receive placebo or
      trimethoprim/sulfamethoxazole following incision and drainage. Follow-up was a call at 2-3
      days & a repeat visit or call at 10-14 days. Treatment failure was defined as: persistent
      erythema, tenderness, and/or draining lesions. New lesion was defined as: primary resolution
      with development of new lesion (furuncle, carbuncle or abscess) at a different location.
      Compliance was evaluated by the return of the study medication or by patient report.
    

Intervention name(s): Trimethoprim-sulfamethoxazole; Placebo group
Intervention type(s): Drug; Drug
Intervention description(s): Participants were randomized to receive placebo or trimethoprim/sulfamethoxazole using a computer randomization program on the initial presentation. The placebo is a Maalox and tonic water combination that resembled the antibiotic in color, texture and taste. The antibiotic dose is a standard trimethoprim/sulfamethoxazole for bacterial infection (10-12mg trimethoprim/kg/day, with a maximum adult dose of 160mg trimethoprim/day, divided into two doses). The concentration of the liquid is 200mg sulfamethoxazole/40mg trimethoprim per 5mL. With a maximum dose of 160mg trimethoprim, this equates to 20mL.; Placebo (Maalox with simethicone and bitter mixture) suspension was dispensed to study participants who were block randomized to receive the placebo.
Other intervention name(s): Septra; Maalox (with simethicone and bitter mixture)
Intervention MeSH terms: Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination; Sulfamethoxazole; Simethicone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: skin abscess; CA-MRSA
To Evaluate the Safety, Tolerability and Pharmacokinetics of CT-P63 in Healthy Subjects
Condition: SARS-CoV-2 Infection
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I study that randomized, double-blind, Placebo-controlled, Parallel Group,
      Single Ascending Dose Study to evaluate Safety, Tolerability and Pharmacokinetics of CT-P63
      in Healthy Subjects.
    

Detailed description: 
      CT-P63 is a monoclonal antibody targeted against SARS-CoV-2 spike RBD as a treatment for SARS
      CoV 2 infection. CT-P63 is currently being developed by the Sponsor as a potential treatment
      for SARS-CoV-2 infection. In this study, safety, tolerability, and pharmacokinetics of CT-P63
      will be evaluated in healthy subjects.
    

Intervention name(s): CT-P63; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CT-P63 will be administered; Placebo-matching CT-P63
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Spa Effects After Exercise
Condition: Health Behavior
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the recovery effect of Spa therapy after aerobic
      exercise in cardiovascular, performance and perceived fatigue. A pragmatic controlled
      repeated measures, single-blind, trial is conducted. Thirty-four recreational sportspeople
      are required to visit a Sport-Centre and are assigned to a Spa-therapy or rest in a bed
      (control group) after complete a spinning session.
    

Detailed description: 
      Subjects perform the recovery session after completing the exercise protocol. Participants
      are allocated to the control or intervention group following an order of arrival to the
      study.

      The spinning session is performed using the same protocol for all participants after 24h
      physical rest. They were asked to perform this session as a regular spinning class. The
      session is carried out in the afternoon (room temperature 22±3.5°C) on a modified spinning
      bike (Keiser®, M3). They are allowed to drink water during the session and performed the
      test, while they listen a compilation of music that lasted 50min composed of 9 tracks.

      Each track corresponds to a specific phase of the spinning session. The phases being labeled
      as warm-up, sitting, seated climbing, jumping, and running, based on the official spinning
      program manual. Some phases are repeated during the session, the compilation being purposely
      designed for beginner practitioners of a spinning class. In addition to the music protocol,
      the participants are asked to maintain a pedal stroke cadence that had previously been
      established for each track. For the resistance applied to the flywheel, the participants are
      free to adjust it according to their sensation and interpretation of the spinning session.

      Recovery Procedures

      A cycle of 3 Vichy shower and whirlpool baths are applied during 30-minutes period. Vichy
      sedative shower are applied for 90-120 sec to the sides of the trunk and the abdomen,
      avoiding as much as possible the gall bladder area, at a temperature of 36-38ºC. A short,
      partial jet spray followed the shower. A whirlpool bath is administered where subjects
      immersed the body until their clavicle level for a 10min period with a water temperature
      ranging 33.5-35.5 ºC. Aromatherapy application using lavender and chamomile oils is used in
      all Spa therapy sessions.

      The control group performed a rest session in supine position in a room with neutral
      temperature condition with a same duration to Spa session. Participants of both groups are
      encouraged to drink water "ad libitum" to prevent dehydration.
    

Intervention name(s): Spa session
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: Spatherpy; Aerobic exercise