bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Empaglifozin and Vildagliptin in Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to perform a comparison of the efficacy and safety of empagliflozin
      and vildagliptin in patients with Type 2 Diabetes Mellitus

      open labelled, multi-centric, parallel, randomized control trial

      In Type 2 Diabetes patients, impact of empagliflozin (10 mg once or twice daily) versus
      vildagliptin (50 mg once or twice daily) assessed for Efficacy & safety parameters to be
      measured at both the baseline and 24-week visits.
    

Detailed description: 
      Background:

      Diabetes is a rampant disease that keeps on getting more and more people affected each year.
      Over 200 million people have been affected worldwide due to this disorder, and many have
      contracted various cardiovascular complications due to uncontrolled diabetes. Though an
      easily manageable disease, if left untreated, diabetes can be fatal. Therefore, it is
      necessary to have drugs available which control diabetes and also limit the progression of
      complications that could arise due to it.

      Objective:

      The aim of this study is to perform a comparison of the efficacy and safety of empagliflozin
      and vildagliptin in patients with Type 2 Diabetes Mellitus

      Methods:

      open labelled, multi-centric, parallel, randomized control trial to be conducted at the
      Department of Diabetes & Endocrinology of two tertiary care hospitals in Karachi, Pakistan.

      The Participants will undergo screening and then were randomized into two groups. The first
      group received empagliflozin (10 mg once or twice daily), and the second group received
      vildagliptin (50 mg once or twice daily. HbA1c, High-density lipoprotein (HDL) levels.,
      Systolic blood pressure, fasting blood glucose, and body weight will be measured at both the
      baseline and 24-week visits.
    

Intervention name(s): Empagliflozin; Vildagliptin
Intervention type(s): Drug; Drug
Intervention description(s): Receiving allocated drug dosage as per clinical needs; Receiving allocated drug dosage as per clinical needs
Intervention MeSH terms: Empagliflozin; Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; Empagliflozin; Vildagliptin; Efficacy; Safety
Safety and Efficacy of a PIKA Rabies Vaccine Containing the PIKA Adjuvant
Condition: Rabies
MeSH terms: Rabies
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I clinical study for an investigational PIKA (Polyinosinic-Polycytidylic Acid Based
      Adjuvant) rabies vaccine comprising Inactivated and Purified Rabies Virus (IPRV) and the PIKA
      adjuvant. The primary objective of the study was to assess the clinical safety of the vaccine
      composition in healthy adult volunteers. The secondary objective was to evaluate the
      vaccine's efficacy based on an accelerated vaccine regimen.
    

Detailed description: 
      A single-center, open label, randomized phase I study in healthy naïve adult subjects. There
      were three study groups; subjects were randomly assigned to groups A (12), B (12) and C (12).
      Group A, as a control arm of the study, had received a commercially available rabies vaccine,
      RABIPUR® and Group B had received doses of the investigational PIKA rabies vaccine. Group C
      received an accelerated vaccine regimen with the investigational PIKA rabies vaccine. Group A
      and B followed the same vaccine regimen of (1-1-1-1), one injection on days 0, 3, 7 and 14
      was administered respectively. Group C received the accelerated regimen (2-2-1), two
      injections on both days 0 and 3 were administered in different arms; and only one injection
      was administered on day 7.

      Each vaccine dose comprise 1.0 ml of PIKA rabies vaccine for Group B and Group C and 1.0 ml
      of RABIPUR® for Group A after reconstitution. The route of administration is intramuscular
      injection, given in the deltoid region of the arm.
    

Intervention name(s): RABIPUR®; PIKA rabies vaccine; PIKA rabies vaccine with an accelerated regimen
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Biological rabies vaccine; Biological rabies vaccine; Biological rabies vaccine
Other intervention name(s): 'PIKA rabies vaccine with PIKA adjuvant; 'PIKA rabies vaccine with PIKA adjuvant
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Pharmacokinetic Interactions Between Hydronidone and Entecavir Capsules in Healthy Chinese Subjects
Condition: Hydronidone
Study type: Interventional
Phase: Phase 1

Summary: 
      This study, by comparing the Hydronidone capsules and entecavir capsule in a single dose and
      steady-state dosing state of both the level of blood drug concentration, assess Hydronidone
      capsules and entecavir capsule for interaction。
    


Intervention name(s): Hydronidone capsules& Entecavir capsules
Intervention type(s): Drug
Intervention description(s): take the Hydronidone capsule and then the entecavir capsule, and then take the last two together
Intervention MeSH terms: Entecavir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluation of the Efficacy of a New Supplement for Hair and Nails - in Vitro, Clinical, Subjective and Instrumental Study
Condition: Hair Loss; Nails, Ingrown
MeSH terms: Alopecia; Alopecia Areata; Nails, Ingrown
Study type: Interventional

Summary: 
      A unicentric, exploratory, prospective clinical an in vitro study to evaluate efficacy and
      safety of a Supplement in improving the quality and general aspects of hair and nails in
      female participants through clinical,in vitro, subjective and instrumental evaluations
    

Detailed description: 
      A unicentric, exploratory, prospective clinical an in vitro study to evaluate efficacy and
      safety of a Supplement in improving the quality and general aspects of hair and nails in
      female participants through clinical, in vitro, subjective and instrumental evaluations.

      It will be necessary 40 female participants aged between 25 and 55 years old with a clinical
      and in vitro diagnosis of telogen effluvium presenting at least one of the following
      characteristics: hair loss problems caused by stress, poor diet and excess of tinctures and
      chemicals procedures applied to hair, and menopausal women.

      The participants will remain in the study for 93 days using the product. Visits will be
      scheduled in D-3, D0, D45, D48, D90, D93.

      Instrumental evaluations: Evaluated on each visit:

        -  To analyze the biological cycle of hair growth using Trichogram test - D-3, D45, D90;

        -  Evaluation of hair growth kinetics using phototrichogram - D-3,D0, D45, D48, D90, D93;

        -  Evaluation of the mechanical strength of the hair structure using EMIC DL 500- D-3, D90

        -  Evaluation of the dermal density of the scalp using the high-frequency ultrasound- D-3,
           D45, D90

        -  Participants will respond to a subjective assessment using a questionnaire to capture a
           subjective efficacy- D45, D90
    

Intervention name(s): A power supplement with biotin
Intervention type(s): Dietary Supplement
Intervention description(s): A power dietary supplement containing aminoacids and vitamins
Intervention MeSH terms: Biotin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: capillary density; strengthening; hair loss
Efficacy and Safety of Trichuris Suis Ova (TSO) as Compared to Placebo
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled, multicenter, and proof of concept
      study with a parallel group design to evaluate the safety and efficacy of oral Trichuris Suis
      Ova (TSO) suspension, as compared to placebo, in patients with moderately to severely active
      Crohn's disease. This study will also have an optional open-label extension for patients
      completing the double-blind phase of the study.
    


Intervention name(s): Trichuris suis ova (TSO); Placebo
Intervention type(s): Biological; Biological
Intervention description(s): TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses); Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: T. suis ova; Trichuris suis ova; Inflammatory Bowel Disease; TRUST-I; TRUSTI; TRUST-1; TRUST1
Intervertebral Disc Augmentation With Minimally Invasive Surgical Procedure
Condition: Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Observational

Summary: 
      The primary purpose of the study is to establish the degree and duration of pain relief
      following minimally invasive surgery for a painful degenerative disc.
    

Detailed description: 
      The investigators will study patient recovery (outcome measures) in patients who have had
      minimally invasive surgery for implantation of human meniscus allograft (HMA) to replace the
      nucleus pulposus of a degenerative intervertebral disc.
    

Intervention name(s): completion of the (VAS) for level of back pain; completion of the (OLBPQ) for assessment of function
Intervention type(s): Other; Other
Intervention description(s): Patients will complete the (VAS) pre-operatively and post-operatively at 6 wks, and 3, 6, 12, and 24 mos.; Patients will complete the (OLBPQ) pre-operatively and post-operatively at 6 wks, and 3, 6, 12, and 24 mos.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with degenerative disk disease at L3-L4, L4-L5, or L5-S1 scheduled to undergo
        surgery for HMA implantation to replace the nucleus pulposus.
      
Keywords: L3-L4; L4-L5; L5-S1; Human Meniscus Allograft; Nucleus pulposus; Minimally invasive surgery; Degeneration of L3-L4 Intervertebral Disc; Degeneration of L4-L5 Intervertebral Disc; Degeneration of L5-S1 Intervertebral Disc
Examining Caffeine as a Treatment for Antidepressant-induced Arousal Dysfunction in Women
Condition: Female Sexual Arousal Disorder
MeSH terms: Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 1

Summary: 
      Antidepressants have negative effects on genital arousal function that hinder quality of life
      and jeopardize medication adherence. Moderate sympathetic nervous system (SNS) activation
      through exercise has shown promising results for improving antidepressant-induced genital
      arousal dysfunction. It is feasible that caffeine - an SNS stimulant - could improve
      antidepressant-induced genital arousal difficulties if ingested prior to sex. The goal of the
      present pilot study is to examine whether the acute administration of 300mg of caffeine
      increases genital arousal in women experiencing antidepressant-induced genital arousal
      difficulties. Women will attend two counterbalanced sessions in which they ingest either
      300mg caffeine or placebo. Fifteen minutes after ingestion, they will view an erotic film
      while their heart rate and genital sexual arousal are measured. Caffeine could serve as a
      low-cost, widely accessible intervention with minimal side effects if efficacy is shown.
    


Intervention name(s): Caffeine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 300mg caffeine will be administered orally via capsules to participants with female sexual arousal disorder.; A placebo pill that matches in size, shape, and color will be administered to participants with female sexual arousal disorder.
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: female sexual dysfunction; female sexual arousal disorder; caffeine
Randomized Controlled Trial Methods for Novel Tobacco Products Evaluation
Condition: Nontherapeutic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to use Randomized Controlled Trial (RCT) methods to examine the
      influence of novel tobacco products on biomarkers of toxicant exposure and disease risk,
      reports of adverse events, and concurrent use of other tobacco products. In this case, the
      novel products are one type of electronic cigarette and an imitation cigarette or cigarette
      substitute.
    


Intervention name(s): e-cigarette; cigarette substitute
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
To Compare Fibrin Glue and Suture in Primary Pterygium Excision With Amniotic Membrane Transplantation
Condition: Pterygium
MeSH terms: Pterygium
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to compared between conventional pterygium excision and AMT
      transplantation with suture and with fibrin glue.
    

Detailed description: 
      There are few studies about use of fibrin glue in pterygium surgery with conjunctival
      auto-graft with promising outcome. Less recurrent rate, less discomfort and halve surgical
      time were reported.

      Up to our knowledge,there is no report of fibrin glue in pterygium excision with amniotic
      membrane transplantation(AMT). There is conventional technique to use AMT in King
      Chulalongkorn Memorial Hospital because some benefits over conjunctival auto-graft e.g.

        -  Preserve healthy superior conjunctiva for future glaucoma filtering surgery

        -  Can use in big or 2-headed pterygium

        -  Not contract as conjunctival graft esp. in case of fibrin glue

        -  Potential easier to use with fibrin glue

        -  Available from Thai Red Cross Eye Bank Comparison(s): amniotic membrane transplantation
           using fibrin glue compare to suture after pterygium excision.
    

Intervention name(s): Amniotic membrane transplantation using fibrin glue
Intervention type(s): Procedure
Intervention description(s): After pterygium excision, amniotic membrane was shaped and attached to bare scleral area using fibrin glue (Quixil®) in 16 eyes of 16 patients of FG group and continuous suture with nylon 10-0 in 16 eyes of 16 patients of SU group.
Other intervention name(s): Quixil®; Nylon 10-0
Intervention MeSH terms: Fibrin Tissue Adhesive
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pterygium; pterygia; excision; amniotic membrane transplantation; fibrin glue; suture
A Study In Healthy Volunteers To Estimate The Effect Of The Active Ingredient Particle Size And Percentage Of The Excipients Used To Formulate The Capsules In The Dissolution Rate Of The Formulations In The Gastrointestinal Tract
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The particle size of the active ingredient may impact dissolution rate in the gastro
      intestinal tract and hence the amount of drug available for absorption. Similarly,
      differences in the percentage of the excipients used in the formulated capsules may affect
      dissolution rate. The purpose of this study is to estimate the effect that particle size and
      percentage of excipients could have in drug absorption, which will improve the manufacturing
      process of the formulated capsules.
    


Intervention name(s): Palbociclib Formulation Reference; Palbociclib Formulation Test; Palbociclib Formulation Test; Palbociclib Formulation Test
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Single 45 mg dose; Dosage form is capsule taken orally.; Single 45 mg dose; Dosage form is capsule taken orally.; Single 45 mg dose; Dosage form is capsule taken orally.; Single 45 mg dose; Dosage form is capsule taken orally.
Intervention MeSH terms: Palbociclib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Treatment for Patellofemoral Pain Syndrome Using Footwear
Condition: Patellofemoral Pain Syndrome
MeSH terms: Patellofemoral Pain Syndrome; Syndrome; Somatoform Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Patellofemoral pain syndrome (PFPS) is the most common running injury and is believed to be
      associated with higher than normal knee joint loading. Footwear has been developed that may
      decrease these knee loads in healthy subjects, but their effects on patients with PFPS are
      unknown. In this study, we aim to test the effects of such footwear on patients with PFPS. We
      hypothesize that patients who receive the footwear intervention will show a decrease in knee
      joint loading, and consequently will show improvements in subjective levels of perceived knee
      pain over a period of six weeks compared to a control condition.
    


Intervention name(s): Knee abduction moment-reducing footwear
Intervention type(s): Device
Intervention description(s): Patients in each study group will be asked to run using their assigned footwear at least 3 times per week (minimum 15 km per week) for six weeks. Each patient will document their perceived knee pain each week throughout the six week intervention.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Footwear; Motion Analysis; Running Injury
Effects of Low-level Mechanical Vibration on Bone Density in Ambulant Children Affected by Duchenne Muscular Dystrophy
Condition: Osteoporosis; Duchenne Muscular Dystrophy
MeSH terms: Osteoporosis; Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional

Summary: 
      Duchenne muscular dystrophy (DMD) is a X-linked recessive disorder due to a mutation of the
      dystrophin gene (Xp21). Dystrophin is a sarcolemmal protein of skeletal and cardiac muscle,
      and its absence causes progressive muscle degeneration and substitution with fat and
      connective tissue. The progressive muscle degeneration leads to loss of autonomous walking
      before the age of 15 years and death for cardiac and/or respiratory failure. There are no
      specific treatment for DMD, and the standard of care is now based on long-term corticosteroid
      (CS) use. The studies on bone mass in DMD are very few, but they agree in reporting the
      presence of a reduced bone mass and an increased rate of fractures probably due to long-term
      steroid therapy and disuse-osteopenia. The aim of this study, involving 20 ambulant DMD boys
      (age 7-10 years) has been the evaluation of the effects of low-level mechanical vibrations on
      bone in a group of ambulant DMD children for 1 year, with RDA-adjusted dietary calcium intake
      and 25OH vitamin D supplementation.
    

Detailed description: 
      All children were instructed to have a daily intake of calcium equal to the 100% of the RDA
      and were supplemented with calcifediol (0.7 mcg/kg/die).

      The 20 boys were randomly assigned to two groups:

      group 1 (mechanical intervention group) = a mechanical device (a small platform designed to
      induce vertical, sinusoidal acceleration) was installed in the home of each boy of group 1.

      group 2 (placebo control group) = a placebo device was installed in the home of each boy of
      group 2

      All boys were instructed to stand on the platform for 10 minutes each day for 12 months.

      Compliance was followed and stimulated through weekly telephone contacts with parents and
      children.
    

Intervention name(s): Low-level mechanical vibrations WITH vertical sinusoidal acceleration; Low-level mechanical vibrations WITHOUT vertical sinusoidal acceleration
Intervention type(s): Device; Device
Intervention description(s): Small platform designed to induce vertical, sinusoidal acceleration.; Small platform designed to NOT induce vertical, sinusoidal acceleration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Duchenne Muscular Dystrophy; children; low bone mass; osteoporosis; low-level mechanical vibration; bone turnover markers
Bioequivalence Study of Azilsartan Tablets in Chinese Healthy Volunteers
Condition: Bioequivalence of Two Azilsartan Formulations
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to determine the bioequivalence of two azilsartan formulations
      after administration of single doses to healthy subjects under fasted and fed conditions.
      These data were to be evaluated statistically to determine if the products meet
      bioequivalence criteria.
    


Intervention name(s): Azilsartan (Zhaoke); Azilsartan (Takeda)
Intervention type(s): Drug; Drug
Intervention description(s): Azilsartan 20mg tablets from Zhaoke; Azilva 20mg tablets from Takeda
Other intervention name(s): Azilsartan; Azilva
Intervention MeSH terms: Azilsartan medoxomil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science