bioihbjkbjnl/mcl2 huggingface dataset:
Study of Inactivated Poliovirus Vaccine Given at an Earlier Schedule With Shorter Intervals
Condition: Level of Immunity Against Poliovirus Infection
Study type: Interventional

Summary: 
      The purpose of this study was to evaluated the effectiveness of inactivated poliovirus
      vaccine at a vaccine schedule that is commonly used in developing countries. The
      effectiveness of inactivated poliovaccine given at this schedule is important to national
      policy makers as they consider vaccination policies after the use of oral polio vaccine is
      discontinued.
    

Detailed description: 
      After polio eradication, access to live polioviruses will be highly restricted, and oral
      poliovirus vaccine (OPV) use must be discontinued. OPV-using countries must decide whether to
      switch to inactivated poliovirus vaccine (IPV) or stop polio vaccination. Because only
      limited data are available on IPV immunogenicity in tropical developing countries, we
      conducted a randomized controlled trial of IPV in Cuba. The objectives of this study were to
      assess the humoral and mucosal immunogenicity conferred by IPV administered at the WHO-EPI
      schedule (6,10,14 wks of age) vs. placebo. A third arm was added to evaluate the
      immunogenicity of IPV administered at 2 and 4 months of age. Antibody titers were measured
      prior to the first dose as well as 1 month after the last dose in each study arm. Target
      sample size was 100 children in each arm. Mucosal (intestinal immunity) was measured
      indirectly through assessing poliovirus excretion in each group after a "natural challenge"
      of trivalent oral polio vaccine (OPV)recieved by study participants through their
      participation in the annual OPV mass campaigns approximately 1 month after their last dose of
      vaccine.
    

Intervention name(s): Inactivated Polio Vaccine given at an accelerated schedule
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: inactived; polio; vaccine; cuba; trial; randomized; eradication
Pharmacokinetic-pharmacodynamic Assessment of Seresis® in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the antioxidant potency of Seresis® in the serum of healthy volunteers and
      the optimal time for blood sampling
    


Intervention name(s): Seresis®; Placebo
Intervention type(s): Drug; Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Botulinum Toxin Type A in Adults With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this project is to investigate if there is a significant difference in active
      joint range of motion, questionnaire on gait function and health related quality of life
      between patients randomized to treatment with Botulinum toxin type A and patients randomized
      to placebo treatment.
    

Detailed description: 
      Cerebral palsy (CP) is a constellation of symptoms and conditions defined as lifelong motor
      dysfunction resulting rom a non-progressive brain lesion occurring pre-, peri- or postnatal
      before the second year of life. CP consists of different aspect of motor disorder including
      spasticity, paresis, incoordination and dystonia

      There is scarce knowledge about the association between spasticity, pain and physical
      function in the adult CP-population, and the systematic follow up of patients with CP
      typically ends at the age of eighteen. Frequently used intervention in spastic cerebral palsy
      for children with gait problems are injections with Botulinum toxin type A (Btx-A) in leg and
      thigh muscles, and three dimensional-gait analysis has become a standard procedure in
      treatment decision and evaluation.

      Botulinum toxin A (Btx- A) is a highly effective treatment in the management of spasticity.
      The first reported success of use of Btx-A in children with cerebral palsy was made in 1993
      by Koman et al. Subsequently, randomized controlled studies on children with spastic type of
      cerebral palsy has documented that Btx-A is effective and safe in the management of muscle
      spasticity in children with CP. There is an implicit, and as of yet, unproven assumption that
      there is no indication for this treatment in the adult CP-population.
    

Intervention name(s): Botulinum toxin type A (Botox); placebo (saline)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adult; Cerebral Palsy; Spastic contractures; Botulinum toxin type A
Translational Control of Anabolic Resistance in Aging Muscle
Condition: Physical Inactivity
Study type: Interventional

Summary: 
      This is an interventional study enrolling older individuals aged 60-85y to observe changes
      during physical inactivity. This study is investigating the relation between short-term
      physical inactivity and the impact of muscle health and function. The enrollment goal is 8
      participants. The study will occur over the course of a month where participants will undergo
      testing before and after a reduction in physically activity levels. There will be a screening
      event collecting baseline data, two body composition scans, muscle function and oral glucose
      tolerance tests and a metabolic study before and after a 2-week period of inactivity. Each
      metabolic study will entail three-muscle biopsies: one before and 2 after the ingestion of
      leucine.
    

Detailed description: 
      Pre-testing- The baseline evaluation will assess muscle function and strength, and an oral
      glucose tolerance test. After the baseline visit, participants will be provided with a step
      activity monitor to track their level of activity. This will provide a baseline of the
      participant's normal level of physical activity so an accurate level of 75% activity
      reduction can be determined. A 3-day daily dietary diary will be provided for the participant
      to self-report prior to the experiment, as well.

      Day 1- After the participant completes their normal activity log and dietary diary, they will
      be asked to return to the research center for a body composition scan and a metabolic study.

      The metabolic study will involve blood sampling from an arm vein and muscle biopsies from the
      thigh before and after a leucine drink.

      2-week period of inactivity- After the metabolic study, the participant will return home and
      maintain a reduced level of activity (75% reduction) for a two-week period. During this time,
      the participant will receive phone calls from research personnel in order to maintain
      adherence to the intervention.

      Day 14- After the 2-week reduced activity period, the participant will return to the research
      center to receive a body composition scan and undergo a metabolic study identical to 'Day 1'.

      Post-testing- After Day 14, the participant will be asked to return once again to the
      research center for a oral glucose tolerance test and the exercise lab for muscle function
      testing.
    

Intervention name(s): Reduced Physical Activity
Intervention type(s): Other
Intervention description(s): Participants will reduce their level of physical activity for 2-weeks as defined as approximately 75% reduction from their baseline level of physical activity.
Other intervention name(s): Muscle Disuse
Intervention model: Single Group Assignment
Intervention model description: Participants will be tested before and 2-weeks after they have reduced their level of physical activity
Masking: None (Open Label)
Primary purpose: Basic Science
Effect of Repeated Dosing of Naproxcinod on Renal Hemodynamic and on Sodium Balance in Healthy Volunteers Before and After a Single Dose of Furosemide
Condition: Renal Hemodynamics
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase 1 study is an 8-day treatment period, randomized, controlled, double-blind, 3
      parallel-groups, monocentric study. The primary objective is to evaluate the effect of
      naproxcinod on the renal function when co-administered with furosemide in comparison to
      naproxen and placebo.
    


Intervention name(s): naproxcinod; Naproxen; placebo; furosemide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): naproxcinod 750 mg bid; Naproxen 500 mg bid; placebo; furosemide
Intervention MeSH terms: Naproxen; Furosemide; Naproxen-n-butyl nitrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
A Study of RGLS8429 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective

      • To assess the safety and tolerability of single ascending doses of RGLS8429

      Secondary Objectives

        -  To identify dose-limiting toxicity (DLT) and to determine the maximum tolerated dose
           (MTD) of a single SC dose of RGLS8429

        -  To characterize the pharmacokinetic (PK) properties of RGLS8429
    

Detailed description: 
      In this randomized, double-blind, placebo-controlled Phase 1 study, a single ascending dose
      of RGLS8429 or placebo will be administered via subcutaneous (SC) injection to healthy
      volunteers to evaluate the safety, tolerability, and PK of RGLS8429.
    

Intervention name(s): RGLS8429; Placebo volume-matching RGLS8429 dose
Intervention type(s): Drug; Drug
Intervention description(s): solution for subcutaneous injection; solution for subcutaneous injection
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: RGLS8429; Autosomal Dominant Polycystic Kidney Disease; ADPKD
Percutaneous Electrical Nerve Stimulation for Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      There is evidence supporting that physical therapy interventions can be effective for the
      management of patients with CTS. No consensus on the best approach exist. It seems clear that
      the median nerve is affected in several ways (compression, inflammation, excursion) in carpal
      tunnel syndrome. Percutaneous Electrical Nerve Stimulation is a treatment approach consisting
      of the application of an electrical current throughout needling filaments placed close to the
      nerve, in this case the median nerve. The purpose of this clinical trial is to compare
      changes in function, symptom severity and the intensity of pain after the application of
      Percutaneous Electrical Nerve Stimulation vs. endoscopic surgery in women with CTS at short-
      and long-term follow-up periods.
    


Intervention name(s): Percutaneous Electrical Nerve Stimulation; Endoscopic surgery of the carpal tunnel
Intervention type(s): Procedure; Procedure
Intervention description(s): Experimental: Percutaneous Electrical Nerve Stimulation The experimental group will receive 3 sessions (once per week) of ultrasound-guided Percutaneous Electrical Nerve Stimulation targeted the median nerve. Once the median nerve is ultrasound identified, the needles will be left in situ at the identified points connected to an electrostimulator (ES-160 ITO co.) applying a biphasic continuous waveform, at low frequency (2 Hz)19 and with 250 microseconds pulse duration for 30mins.; The surgical group will receive a surgical procedure consisting of the decompression and release of the median nerve at the carpal tunnel performed by an experienced surgeon according to standardized protocols.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Towards a Viral Etiology of Periodontal Disease in Relation to Radiotherapy Treatment of Head and Neck Cancers
Condition: Periodontal Disease
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      The treatment of otolaryngology (OLR) cancer is based on surgery, radiation, sometimes used
      in combination with chemotherapy. Patients treated with radiotherapy have multiple oral
      diseases: mucositis, hyposalivation, tissue fibrosis, exacerbation of periodontitis. Over 70%
      of patients with head and neck cancers treated with radiotherapy have a lower level of dental
      clinical attachment and 92% have loose teeth or missing. The management of these oral
      complications is a priority in OLR oncology. The aim is to improve the oral health of
      patients to achieve a comfortable life acceptable and necessary for healing.

      This project proposes to deepen the investigation with two main objectives:

        1. To study in vivo the effect of radiation treatment on the evolution of the viral flora
           of the periodontium in a cohort of patients and matched controls.

        2. To study in vitro the effects of irradiation on the replication EBV (herpesvirus) in
           producing websites lymphoepithelial tonsillar, and atypical dendritic cells associated
           with EBV that existence were recently discovered.
    


Intervention name(s): periodontal pocket samples
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety and Pharmacokinetic Comparison of Cilostazol SR and IR Formulations in Healthy Korean Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study investigates safety and pharmacokinetic comparison of Pacific Pharma's PP-101 SR
      (test formulation) and Otsuka's Pletaal® IR (reference formulation) for single and multiple
      doses and food effects on Pacific Pharma's PP-101 SR in healthy volunteers.
    


Intervention name(s): Pletaal
Intervention type(s): Drug
Intervention description(s): Part 1: a single dose of the SR (200mg x 1 tablet, QD) and IR (100mg x 2 tablets, BID) formulation of cilostazol orally 7 days apart in a fasted state
Part 2: a single dose of the SR (200mg x 1 tablet, QD) formulation of cilostazol 7 days apart in a fasted and a fed state
Part 3: multiple doses of the two formulations for eight consecutive days 21 days apart
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics
Same-Day Combination of VI Peel and Botox for Correction of Sun Damage, Fine Lines and Wrinkles
Condition: Photoaging; Wrinkle; Sun Damaged Skin
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is being conducted to improve standards of care in the cosmetic treatment of sun
      damage, fine lines, and wrinkles. VI Peels® and Botox® have been used cosmetically to improve
      patient concerns as monotherapies. This study seeks to confirm that the same-day combination
      creates no additional side-effects and furthermore that patient satisfaction is heightened as
      a result.
    

Detailed description: 
      This study seeks to utilize the mechanisms of action of both products to simultaneously
      address fine lines and wrinkles. VI Peels contain a synergistic blend of acids that produce
      keratolytic and kerato-coagulation qualities focused on desquamation and cellular renewal.
      The VI Peel blend contains Trichloroacetic Acid, Phenol, Salicylic Acid, Retinoic Acid and
      Ascorbic Acid. Botox containing Botulinum toxin type A is a purified substance, derived from
      a bacterium that block muscular nerve signals temporarily preventing the muscular contraction
      and subsequent wrinkle formation.

      The expected benefit of this investigational combination include improvements to Standards of
      Care in relation to treatment of the cosmetic patient by establishing safety of the
      combination treatment, improving patient outcomes by simultaneously addressing sun damage,
      fine lines, and wrinkles through dual mechanisms, and overall improvement to patient
      satisfaction.
    

Intervention name(s): Same Day Intervention of VI Peel (Procedure) and Botulinum Toxin (Drug)
Intervention type(s): Combination Product
Intervention description(s): Same-Day combination of VI Peel applied to the full face, followed by Botox injection per label to the face.
Other intervention name(s): Botox; VI Peel; Neurotoxin; Chemical Peel
Intervention MeSH terms: Botulinum Toxins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Botox; VI Peel; Wrinkles; Sun Damage
Impact of Misoprostol on Blood Loss In Myomectomy Operations
Condition: Leiomyoma
MeSH terms: Leiomyoma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this research work is to assess the effect of using single preoperative dose of
      rectal misoprostol in abdominal myomectomy operations on blood loss, duration of the
      operation and possible operative complications
    

Detailed description: 
      This study is a randomized, double-blind, controlled study that will be conducted in Ain
      Shams University Maternity Hospital.

      A total of 50 women scheduled to undergo myomectomy for symptomatic uterine myoma will be
      included in this study after taking their consent for this clinical trial after full
      explanation of the trial.

      The total of 50 included patients will be divided into two groups: Group A (Study group;):
      will Include 25 patients undergoing myomectomy operation will receive two tablets of
      misoprostol (400 mcg) rectally two hours before the operation.Group B (Control group): will
      Include 25 patients undergoing myomectomy operation will not receive misoprostol before the
      operation.
    

Intervention name(s): Misoprostol; Placebo( for misoprostol)
Intervention type(s): Drug; Drug
Intervention description(s): 25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation; Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.
Other intervention name(s): Cytotec
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Effect of Cranberry and Agaves Extract on Microbiota and Intestinal Health
Condition: Endotoxemia; Metabolic Syndrome; Glucose Metabolism Disorders; Insulin Resistance
MeSH terms: Endotoxemia; Metabolic Syndrome; Insulin Resistance; Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional

Summary: 
      The growing prevalence of obesity and type 2 diabetes (T2D) is a major public health problem.
      Recent studies have clearly established that the gut microbiota plays a key role in the
      investigator's propensity to develop obesity and associated metabolic health disorders. The
      gut microbiota compositions plays a decisive role in glucose metabolism and the chronic
      inflammatory state associated with insulin resistance. Consuming prebiotic rich diet,
      including polyphenol and inulin rich food could help modulate favorably the gut microbiota
      which could lead to a reduction of endotoxemia and beneficial metabolic health effects.
    

Detailed description: 
      It is now recognized that overweight individuals have altered microbiota which could lead to
      intestinal barrier defects and chronic inflammation disorders. Polyphenols such as
      Proanthocyanidins may modulate the gut microbiota thereby providing beneficial effects on
      metabolic health. Inulin is a well known prebiotic that could stimulate growth of favorable
      bacteria in the gut.

      The overall goal is to determine the efficacy and synergy of a supplement of polyphenols from
      cranberry extract with or without a supplement of inulin from agaves to reduce chronic
      inflammation and endotoxemia and to improve glucose metabolism and insulin sensitivity by
      modulating microbiota of overweight human subjects with metabolic syndrome symptoms.
    

Intervention name(s): Cranberry; Agaves; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Supplementation of polyphenols from cranberry extract; Supplementation of inulin from Agaves powder; Supplementation with placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Treatment of Psoriasis Using Acitretin in HIV-Positive Patients
Condition: HIV Infections; Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the efficacy of acitretin in the treatment of psoriasis in HIV/AIDS patients.

      Etretinate, a retinoid, has proven successful in the treatment of HIV-infected patients with
      psoriasis, but it has an elimination half-life of 100 days. Acitretin, a metabolite of
      etretinate, has a much shorter half-life of 2 to 3 days. Acitretin has proven effective in
      treating psoriasis in patients without HIV infection by reducing skin involvement and
      clearing of the condition, but it has not been thoroughly evaluated in HIV-infected patients.
    

Detailed description: 
      Etretinate, a retinoid, has proven successful in the treatment of HIV-infected patients with
      psoriasis, but it has an elimination half-life of 100 days. Acitretin, a metabolite of
      etretinate, has a much shorter half-life of 2 to 3 days. Acitretin has proven effective in
      treating psoriasis in patients without HIV infection by reducing skin involvement and
      clearing of the condition, but it has not been thoroughly evaluated in HIV-infected patients.

      Patients receive acitretin daily, with dose increases every 4 weeks based on quantitative
      assessment of the skin using the Psoriasis Area and Severity Index (PASI). Treatment
      continues for a total of 20 weeks. Patients are followed every 2 weeks.
    

Intervention name(s): Acitretin
Intervention type(s): Drug
Intervention MeSH terms: Acitretin
Primary purpose: Treatment
Keywords: Psoriasis; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Acitretin