bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity and Interchangeability of Two Inactivated Hepatitis A Vaccines
Condition: Hepatitis A
MeSH terms: Hepatitis A; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, double-blind clinical trial of two inactivated hepatitis A vaccines in
      healthy children, immunogenicity and interchangeability of the two inactivated hepatitis A
      vaccines were evaluated.
    

Detailed description: 
      This was a monocenter, comparative trial in which healthy children were randomized to receive
      two doses of hepatitis A vaccine 6 months apart. The trial was conducted in accordance with
      the Edinburgh version of the Declaration of Helsinki. The study was approved by the Ethics
      Committee. Parents or legal guardians of all participants gave written informed consent prior
      to study entry. Eligible subjects were between 18m and 6 years of age, When enrolled,
      children were randomized to four equal groups with different intervention. Immunogenicity and
      interchangeability of two inactivated hepatitis A vaccines were evaluated.
    

Intervention name(s): Healive+Healive; Healive+Havrix; Havrix+Havrix; Havrix+Healive
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Hepatitis A vaccine (Healive), 250 u per dose per 0.5 millilitre. Vaccines will be administered two doses in the deltoid muscle of the arm 6 months apart; Two kinds of Hepatitis A vaccines, Healive(250 u per dose per 0.5 millilitre) and Havrix(720 ELU per dose per 0.5 millilitre). The first dose will be administered with Healive, followed by another dose of Havrix after 6 months; Hepatitis A vaccine (Havrix), 720 ELU per dose per 0.5 millilitre. Vaccines will be administered two doses in the deltoid muscle of the arm 6 months apart; Two kinds of Hepatitis A vaccines, Healive(250 u per dose per 0.5 millilitre) and Havrix(720 ELU per dose per 0.5 millilitre). The first dose will be administered with Havrix, followed by another dose of Healive after 6 months
Other intervention name(s): Hepatitis A vaccine; Hepatitis A vaccine; Hepatitis A vaccine; Hepatitis A vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Preoperative Prediction Model of Pathological Outcomes (Mesorectum Quality and Positive Circumferential Resection Margin) in Patients With Mid-low Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Observational

Summary: 
      Elaboration of a preoperative prediction model of the quality of the mesorectum and the
      involvement of the circumferential margin in patients with mid-low rectal cancer who undergo
      laparoscopic anterior rectal resection.

      In a second phase the investigators will study the utility of the prediction model in
      classifying patients with high risk of suboptimal quality of mesorectum and/or positive
      circumferential margin. Patients with high preoperative risk will undergo a transanal total
      mesorectal excision and patients with low risk a laparoscopic transabdominal mesorectal
      excision. The investigators finally will compare pathological outcomes ( quality of
      mesorectum and circumferential margin), survival and recurrence between the two groups.
    


Intervention name(s): Transanal total mesorectal excision of rectal cancer
Intervention type(s): Procedure
Intervention description(s): To perform a total mesorectal excision through a transanal approach
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients affected of mid-low rectal cancer
Pilot Trial Investigating Fermented Whey Supplementation in Healthy Adults
Condition: Healthy
Study type: Interventional

Summary: 
      Pilot trial: 6-week single arm intervention. Healthy adults (male and female) consume
      Molkosan (fermented whey) twice a day (AM & PM).
    

Detailed description: 
      Molkosan® is made from fresh organic whey using a special fermentation process involving
      lactic acid producing bacteria (L+ lactic acid 70g/L). The company, A.Vogel (Roggwil,
      Switzerland) will provide the product and we will collect biological samples for analysis in
      a proof of concept study design that will provide preliminary data for future larger studies.
    

Intervention name(s): Molkosan
Intervention type(s): Dietary Supplement
Intervention description(s): Twice daily (AM and PM) 20ml of fermented whey concentrate consumed diluted in 200ml water
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Food supplement, Fermented food, Whey
A Trial Investigating the Effect of Semaglutide on Hypoglycaemic Counterregulation Compared to Placebo in Subjects With Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate the effect of
      semaglutide on hypoglycaemic counter-regulation compared to placebo in subjects with type 2
      diabetes.
    


Intervention name(s): semaglutide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 periods of 12 weeks of once weekly dosing with multiple doses of semaglutide, for subcutaneous (s.c., under the skin) injection, escalated up to 1.0 mg semaglutide.
Each treatment period will be followed by a hypoglycaemic clamp; 2 periods of 12 weeks of once weekly dosing, subcutaneous (s.c., under the skin) injection.
Each treatment period will be followed by a hypoglycaemic clamp.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Taste Assessment Study of 2 Atazanavir Powder Formulations in Healthy Subjects
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the sweetness of 2 new atazanavir powder for oral use
      (POU) formulations to the current atazanavir POU in healthy participants and to select 1
      atazanavir POU that has the sweetness most similar to the current atazanavir POU.
    

Detailed description: 
      This study is a taste assessment study designed to select a new atazanavir powder for oral
      use (POU) formulation that is similar in sweetness to the current POU formulation.
      Participants were to taste and then spit out the POU formulations, without swallowing them.
      Study Classification: Other. This is a taste study
    

Intervention name(s): Atazanavir (current formulation); Atazanavir, powder for oral use 1 (POU1); Atazanavir (POU2)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Solution, oral, atazanavir 15 mg/5 mL with 10% aspartame, single dose; Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame, single dose; Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame and sucralose, single dose
Other intervention name(s): Reyataz; Reyataz; Reyataz
Intervention MeSH terms: Atazanavir Sulfate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Pharmacokinetics of Topical SB204 in Adolescents With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Single-center, Open-label, Pharmacokinetic, Safety and Tolerability Study of SB204
      in Adolescents with Moderate to Severe Acne Vulgaris
    

Detailed description: 
      This is a single-center, open-label study to be conducted in 18 otherwise healthy adolescents
      with moderate to severe acne vulgaris. Repeat blood samples will be obtained on Day 1 and Day
      21 pre and post treatment to characterize systemic exposure to hMAP3 and nitrate. Subjects
      will receive a low-nitrate diet for 12 hours prior to and during the PK sampling period
    

Intervention name(s): SB204 4%
Intervention type(s): Drug
Intervention description(s): Topically Once Daily (AM)
Other intervention name(s): NVN1000
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Foreign Body Swallows in Pediatrics
Condition: Foreign Body in Oropharynx
MeSH terms: Foreign Bodies
Study type: Observational

Summary: 
      Foreign Body Ingestion (FBI) is a common clinical emergency in children. Most FBs smoothly
      pass through the digestive tract without complications; nevertheless, some FBs can cause
      severe morbidity and mortality. The current work aimed at evaluating how FBI can cause
      respiratory distress and stridor as well as their severity according to age, gender, lodgment
      site, and type of the object. Factors influencing morbidity and mortality among studied
      patients will be deliberated as well.
    

Detailed description: 
      Background: Foreign Body Ingestion (FBI) is a common clinical emergency in children. Most FBs
      smoothly pass through the digestive tract without complications; nevertheless, some FBs can
      cause severe morbidity and mortality. The current work aimed at evaluating how the FBI can
      cause respiratory distress and stridor as well as their severity according to age, gender,
      lodgment site, and type of the object. Factors influencing morbidity and mortality among
      studied patients will be deliberated as well.

      Methods: It is a hospital-based descriptive study where all children between birth and 16
      years of age who were admitted from January 1 st, 2018 to December, 31th 2021 for FBs removal
      were analyzed. All cases were subjected to complete history taking, physical, radiological,
      and bronchoscopic examination.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        children between birth and 16 years of age
      
Keywords: Foreign Bodies; Child; Respiratory distress; Hypopharynx; Esophagoscopy
the Effect of Vestibular Rehabilitation in Autistic Children
Condition: Autistic Spectrum Disorder; Vestibular Disorder; Sensory Integration Disorder
MeSH terms: Vestibular Diseases; Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This study was conducted to clarify the effect of vestibular education for autistic children
      on "sensory profile" and "postrotary nystagmus". In the study, the results of the two groups
      were compared through the treatment of sensory integration: the once who got the education
      and the once who did not. For this study, 26 autistic children were included who joined the "
      Çatalca District Unit of Disabled the Project of No Disabilities ", who was diagnosed with
      autism, who was 3-10 years (older than 36 months younger than 11 years). For each child, the
      analysis of the sensory integration and nystagmus was applied twice; at the beginning and at
      the end of the research. At the beginning of the research, the children were divided into two
      groups randomly drawn by lots. The first group was given the education of sensory integration
      with vestibular education and the second group was given the education of sensory integration
      without vestibular education. Both groups were educated for 10 weeks, 2 days a week with 40-
      minute sessions.
    


Intervention name(s): The education of sensory integration with vestibular education
Intervention type(s): Other
Intervention description(s): Tactical, proprioceptive, visual and auditory senses were used in sensory integrity training sessions. In this group, the training program on tactile, proprioceptive, visual and auditory sensory activities was carried out for 2 weeks and 40 minutes. Sensory integrity training was performed by the physiotherapist and in the sensory room.
At the end of the training sessions, mothers were informed about the application of sensory integrity training to daily activities.Sensory integrity therapy room added tactile, proprioceptive, visual and auditory sensory materials as well as materials for vestibular sensation. Vestibular sensory materials, skateboard, swing, hammock, bowl, ball, ball pool, slide, climbing bar, trampoline, and balance board were used.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Trial of SB-509 in Subjects With Diabetic Neuropathy
Condition: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Polyneuropathy
MeSH terms: Diabetic Neuropathies; Polyneuropathies; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to evaluate the clinical effects of the investigational drug,
      SB-509, in subjects with diabetic neuropathy.
    

Detailed description: 
      SB-509 contains the gene (DNA-a kind of biological "blueprint") for a protein. When a
      researcher injects SB-509 into your legs, the drug enters the muscle and nerve cells around
      the injection site and causes these cells to make a protein. This protein causes your cells
      to increase production of another protein called vascular endothelial growth factor (VEGF),
      which may improve the structure and function of nerves. In addition, there are changes in the
      levels of additional proteins in your cells. These proteins function to promote the growth of
      cells, are structures in cells, help synthesize products, and affect immune cells, and some
      have unknown functions. This increase in your own VEGF proteins may protect and repair the
      damaged nerves caused by diabetic neuropathy.
    

Intervention name(s): SB-509; Saline
Intervention type(s): Drug; Other
Intervention description(s): SB-509 60 mg, 3 treatments, and 5 months treatment period
Other intervention name(s): 30 ml saline, 3 treatments
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Diabetic neuropathy; Diabetes Type 1 or 2; Moderately severe sensorimotor diabetic polyneuropathy
Study to Evaluate the Effect of UGT Inhibition by Valproic Acid on the Pharmacokinetics of BIIB074
Condition: Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the effect of multiple doses of the UGT
      inhibitor valproic acid on the single-dose pharmacokinetics of BIIB074. The secondary
      objectives of this study are to evaluate the safety and tolerability of BIIB074 when
      administered alone and when coadministered with the UGT inhibitor valproic acid and to
      evaluate the effect of the UGT inhibitor valproic acid on the PK of the M13, M14, and M16
      metabolites of BIIB074.
    


Intervention name(s): BIIB074; Valproic Acid
Intervention type(s): Drug; Drug
Intervention description(s): Administered as specified in the treatment arm; Administered as specified in the treatment arm
Other intervention name(s): Depakote, Depakene, Stavzor, and Valproic
Intervention MeSH terms: Valproic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteer
Efficacy of Low-dose Dexmedetomidine to Prevent Delirium in Liver Transplant Patients
Condition: Liver Transplantation
MeSH terms: Delirium
Study type: Interventional
Phase: Phase 4

Summary: 
      To test the effect of low-dose dexmedetomidine for lowering the incidence of postoperative
      delirium in liver transplant patients in the ICU.

      Single center prospective randomized placebo controlled clinical trial 0.1mcg/kg/hr of
      dexmedetomidine or equivalent amount of saline infusion started after induction of anesthesia
      for liver transplantation and continued until 48 hours after surgery.

      Outcomes will be assessed up to 1 week or transfer to ward, whichever comes first.
    


Intervention name(s): Precedex; placebo control
Intervention type(s): Drug; Drug
Intervention description(s): infusion of 0.1mcg/kg/hr of precedex; placebo
Other intervention name(s): 0.9% saline
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: delirium; incidence; dexmedetomidine
Degarelix in the Treatment of Endometriosis Recurrence
Condition: Endometriosis
MeSH terms: Endometriosis; Recurrence
Study type: Interventional
Phase: Phase 3

Summary: 
      The long acting GnRH antagonist degarelix will be tested for the treatment of women with
      endometriosis recurrence compared with classical GnRH analog treatment. Pain symptom
      disappearance and disease free time during follow-up will be the outcomes for establishing
      which medical treatment is the best in endometriosis recurrence treatment.
    

Detailed description: 
      Endometriosis is a chronic disease affecting 5-10% of women in reproductive age, showing
      recurrence after surgery at least in 20-50% after 5 years of follow-up. The long acting GnRH
      antagonist degarelix, which do not have the flare-up effect at the opposite of GnRH agonist
      and strongly suppress LH secretion and thecal cell activity may show a better effects on
      endometrial implants than GnRH agonist.
    

Intervention name(s): degarelix; goserelin
Intervention type(s): Drug; Drug
Intervention description(s): 180 women will be treated with degarlix 80 mg, in only one administration covering three months; 180 women will be treated with decapeptyl 3.6 every month for three months
Other intervention name(s): firmagon; decapeptyl
Intervention MeSH terms: Goserelin; Triptorelin Pamoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Endometriosis; long acting GnRH antagonist; Degarelix; Recurrence; Pelvic Pain
Effects of Carbohydrate in Diet and Supplements on the Gastrointestinal Tolerability of LIK066
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to determine if LIK066 taken with a meal containing low
      carbohydrate is associated with less diarrhea compared to a high carbohydrate meal and to
      assess the potential effects of supplements such as psyllium or calcium carbonate on
      alleviating diarrhea associated with LIK066.
    


Intervention name(s): LIK066; Carbohydrate 50%; Carbohydrate 25%; Carbohydrate 8%; Carbohydrate 0%; Psyllium; Calcium carbonate
Intervention type(s): Drug; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): LIK066 50 mg tablets. Open-label, bulk, blister-pack.; 50% carbohydrate in breakfast meal; 25% carbohydrate in breakfast meal; 8% carbohydrate in breakfast meal; 0% carbohydrate in breakfast meal; Powder 6 grams; Liquid 1 gram (4 mL equivalent sugar free)
Other intervention name(s): MetaMucil®; Quality Value®
Intervention MeSH terms: Licogliflozin; Calcium Carbonate; Psyllium; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: obesity; overweight; body mass index; BMI; diarrhea
Effects of a Pre-Workout Dietary Supplement on Training Adaptations
Condition: Dietary Modification
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of a pre-workout dietary supplement
      during resistance training on training adaptations.
    

Detailed description: 
      A number of nutritional strategies have been developed to optimize nutrient delivery prior to
      exercise. This includes providing carbohydrate and a number of ergogenic nutrients prior to,
      during and/or following exercise. As a result, a number of pre-workout supplements have been
      developed to increase energy availability, promote vasodilation and/or positively affect
      exercise capacity. The purpose of this study is to investigate the effects of ingesting a
      pre-workout dietary supplement during resistance training on training adaptations.
    

Intervention name(s): C4 Extreme, C4 Extreme (without Advantra Z)
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Immunogenicity and Safety of Tetravalent Dengue Vaccine (TDV) at the End of Shelf Life in Healthy Adults
Condition: Dengue Fever
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and immune response of a naturally aged
      lot of tetravalent dengue vaccine (TDV) in healthy participants, aged 18 to 60 years, in
      non-endemic country(ies) for dengue.
    

Detailed description: 
      The vaccine being tested in this study is tetravalent dengue vaccine (TDV). The primary
      objective of this study is to evaluate the immune response and safety of a naturally aged
      (>12 months stored at 2°C to 8°C) lot of TDV in a healthy adult population in country(ies)
      non-endemic for dengue. The assessment of a naturally aged lot of TDV in this clinical trial
      will provide an important contribution to data on TDV stability throughout the shelf life of
      the product.

      The study will enroll approximately 200 participants. Participants will be enrolled to the
      one treatment group:

      Tetravalent Dengue Vaccine (TDV)

      All participants will receive subcutaneous (SC) injection on Day 1 (Month 0) and Day 90
      (Month 3).

      This multi-center trial will be conducted in the United States. The overall time to
      participate in this study is 9 months. Participants will make multiple visits to the clinic
      including a final visit at Day 270 (Month 9).
    

Intervention name(s): Tetravalent Dengue Vaccine (TDV)
Intervention type(s): Biological
Intervention description(s): TDV SC injection.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Live Attenuated Tetravalent Dengue Vaccine
Pediatric Subjects With Tinea Corporis
Condition: Tinea Corporis
MeSH terms: Tinea
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is being done to see how well the study cream works when applied once a day to
      affected area of child (where they have ringworm). The results will be compared to those seen
      with a placebo cream which has no active ingredient. Safety of the cream will also be
      measured.
    

Detailed description: 
      The objectives of this study are to evaluate the safety and efficacy of Naftin (naftifine
      hydrochloride) Cream, 2% applied once daily for 2 weeks, compared to its vehicle in the
      treatment of pediatric subjects aged 2 to 17 years and 11 months with positive potassium
      hydroxide (KOH), positive dermatophyte culture, and clinical signs and symptoms of tinea
      corporis.
    

Intervention name(s): Naftin Cream; Placebo Cream
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Tinea Corporis; Ringworm