bioihbjkbjnl/mcl2 huggingface dataset:
Pilot Study of a Suprachoroidal Retinal Prosthesis
Condition: Retinitis Pigmentosa; Choroideremia
MeSH terms: Retinitis; Retinitis Pigmentosa; Choroideremia
Study type: Interventional

Summary: 
      This study will be an initial proof of concept study, to evaluate safety and efficacy of a
      prototype suprachoroidal retinal implant
    


Intervention name(s): Prototype wide view suprachoroidal retinal prosthesis
Intervention type(s): Device
Intervention description(s): Manufacturer = Bionics Institute, Australia
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Kinesio Taping on Mutational Falsetto
Condition: Mutational Falsetto; Dysphonia
MeSH terms: Dysphonia; Hoarseness
Study type: Interventional

Summary: 
      This study aimed to assess of efficacy of the kinesio-taping on male patients suffering from
      mutational falsetto
    

Detailed description: 
      Mutational falsetto is a functional voice disorder involving a failure to transition from the
      high-pitched voice of childhood to the lower-pitch ed voice of adolescence and adulthood. In
      the recent years, kinesio taping has begun to be employed for treating dysphonia patients. We
      hypothesized that, because the kinesio taping relaxes the suprahyoid muscles and pushes the
      larynx backward, it could also be used as a therapy of mutational falsetto. This study aimed
      to assess of efficacy of the kinesio taping on male patients suffering from mutational
      falsetto.
    

Intervention name(s): Kinesio Tex Gold
Intervention type(s): Device
Intervention description(s): The Kinesio Tex Gold is a kinesio tape that had been certified and patented.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: kinesio taping; mutational falsetto; therapy; dysphonia
Eval 3-Drug Therapy Diethylcarbamize, Albendazole and Ivermectin That Could Accelerate LF Elimination Outside of Africa
Condition: Lymphatic Filariasis
MeSH terms: Filariasis; Elephantiasis, Filarial; Elephantiasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will determine if a combination of 3 drugs used to treat the infection that cause
      lymphatic filariasis (LF) due to Wuchereria bancrofti infection are more effective in killing
      or sterilizing the adult worms compared to just 2 of the 3 drugs that usually given to treat
      this infection. The three drugs used together are called albendazole (ALB), ivermectin (IVM)
      and diethylcarbamazine (DEC). The usual treatment in Papua New Guinea (PNG) for lymphatic
      filariasis are DEC and ALB. A combination of these 3 drugs has not been previously used to
      treat LF.
    

Detailed description: 
      This study will determine whether a single dose of the triple drug regimen of DEC/Iver/Alb is
      non-inferior to annual treatments with DEC/Alb in inducing sustained clearance of Mf in LF
      infected subjects (>50 Mf/ml) at 36 months post-treatment. This study also tests the
      hypothesis that single dose of triple drug is super in sustained clearance of microfilariae
      compared to single dose of DEC/ALB.

      There will be 3 treatment arms as follows:

        1. The comparator (standard treatment) DEC 6 mg/kg + Alb 400 mg administered annually (at
           0, 12, and 24 months).

        2. DEC 6 mg/kg + Alb 400 mg given once

        3. DEC 6 mg/kg + Alb 400 mg + Iver 200 µg/kg administered once only at the beginning of the
           RCT (0 month).
    

Intervention name(s): Diethylcarbamazine; Albendazole; Ivermectin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Diethylcarbamazine 6mg/kg; Albendazole 400mg; Ivermectin 200 mcg/kg
Other intervention name(s): DEC; ALB, Albenda; IVM, Stromectol
Intervention MeSH terms: Ivermectin; Albendazole; Diethylcarbamazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diethycarbamazine; Albendazole; Ivermectin; Lymphatic filariasis
Mortality Following Surgery for Proximal Femoral Fractures
Condition: Fracture of Neck of Femur (Hip)
MeSH terms: Fractures, Bone; Femoral Fractures; Femoral Neck Fractures
Study type: Observational

Summary: 
      Proximal femoral fractures are most frequent traumatologic and orthopedic diagnoses
      undergoing surgery. It affect most seniors and accompanied by a series of complications. The
      aim of our retrospective clinical trial is to establish a thirty-day mortality rate after
      surgical solutions, mortality during hospitalization and compare the types of anesthesia
      chosen during the performance (general vs. subarachnoid anesthesia).
    

Detailed description: 
      We evaluate relationship between the monitored parameters and 30 day survival.

      Observed parameters:

        -  age of the patient

        -  sex of the patient

        -  90 days mortality rate

        -  American Society of Anesthesiologists (ASA) score

        -  time since injury and surgery (hours)

        -  whether surgery was initiated during the day (7:00 - 20:00) or at night (20:00-07:00)

        -  type of administered anesthesia (GA, epidural anaesthesia, Subarachnoid (spinal) block)

        -  hemoglobin level prior to surgery

        -  haemotransfusion administration during surgery

        -  perioperative administration of vasopressors

        -  anesthetist erudition (with / without accomplished residency)

        -  surgeon erudition (with / without accomplished residency)
    

Intervention name(s): hip fracture surgery
Intervention type(s): Procedure
Intervention description(s): we evaluate the relationship between the monitored parameters and 30 day survival
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        isolated fracture of proximal femur indicated for surgery
      
Keywords: hip fracture; proximal femur; pertrochanteric fracture; subtrochanteric fracture; subcapital fracture; safety issue; anesthesia
Dl-3-n-butylphthalide and Cerebrolysin Treatment in Acute Ischemic Stroke
Condition: Acute Cerebral Stroke Within 12 Hours for the First Time
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The investigators conducted a randomized, double-blind, trial enrolled 60 patients within 12
      hours of acute ischemic stroke (AIS) in China. Patients were randomly assigned to receive a
      10-day infusion of dl-3-n-butylphthalide (NBP) or cerebrolysin, or placebo. National
      Institutes of Health Stroke Scale (NIHSS) and Barthel Index (BI) were used to evaluate the
      efficacy in the patients with AIS at 11-day and 21-day after therapy. Adverse events were
      also analyzed among the three groups.
    


Intervention name(s): Dl-3-n-butylphthalide; Cerebrolysin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intravenous infusion of 100 ml dl-3-n-butylphthalide and sodium chloride injection for 10 days, twice daily.; Intravenous infusion of 30 ml Cerebrolysin per day in 100 ml normal saline for 10 days.; 100 ml saline intravenous infusion once daily for 10 days.
Other intervention name(s): CSPC NBP Pharmaceutical Co., Ltd., Shijiazhuang, China; Ever Pharma, Unterach am Attersee, Austria; Hebei Tiancheng Pharmaceutical Co., Ltd., Cangzhou, China
Intervention MeSH terms: Cerebrolysin; 3-n-butylphthalide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute ischemic stroke; Dl-3-n-butylphthalide; Cerebrolysin
Dysport® Adult Lower Limb Spasticity Follow-on Study
Condition: Post-stroke Spasticity; Spasticity Post-Traumatic Brain Injury
MeSH terms: Muscle Spasticity; Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to assess the long term safety of Dysport® in
      hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over
      repeated treatment cycles.
    


Intervention name(s): Botulinum toxin type A
Intervention type(s): Biological
Intervention description(s): I.M. (intramuscular) injection on day 1 of each treatment cycle.
Other intervention name(s): AbobotulinumtoxinA (Dysport®)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate Safety, Side Effects, Muscle Activity and Speed of Gastric Emptying of GSK962040
Condition: Gastroparesis
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 1

Summary: 
      Motilin is a peptide whose action is controlled by motilin receptors located in the gut.
      Action of Motilin at motilin receptors increases the gastric emptying rate (rate of emptying
      of food and fluid from the stomach). Compounds which stimulate motilin receptors therefore
      provide a potential approach to the treatment of a range of clinical conditions where delayed
      gastric emptying may contribute to symptoms, such as enteral feeding intolerance
      (post-operative or intensive care patients), gastroparesis, diabetic gastroparesis, and
      functional dyspepsia.

      This study is the First Time In Human study for the motilin receptor agonist, GSK962040.
    


Intervention name(s): GSK962040; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK962040 will be supplied in the following tablet strengths: 1 milligram, 5m milligrams, 25 milligrams, 125 milligrams.; Subjects will receive placebo.
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: gastric emptying; pharmacokinetic; tolerability; safety; GSK962040; gut motility; First Time in Human
An Efficacy and Safety Study of Fremanezumab in Adults With Migraine
Condition: Migraine Prophylaxis
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, and tolerability of monthly
      and quarterly subcutaneous (sc) injections of fremanezumab compared with sc injections of
      placebo in participants with chronic migraine (CM) or episodic migraine (EM) who have
      responded inadequately to 2 to 4 classes of prior preventive treatments.

      Approximately equal numbers of participants from each subgroup (CM and EM) are randomized in
      blinded-fashion 1:1:1 into one of 3 treatments for the subgroup - 2 active treatments and 1
      placebo treatment- consisting of monthly injections for 3 months (up to Week 12). Then all
      participants continue into an open-label extension of 3 months (up to Week 24) during which
      everyone is administered sc injections of fremanezumab.
    


Intervention name(s): Fremanezumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Fremanezumab will be administered per dose and schedule specified in the arm.; Placebo matching to fremanezumab will be administered per schedule specified in the arm.
Other intervention name(s): TEV-48125
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
IMP4297 DDI (Drug-Drug Interaction)Trial in Healthy Male Volunteers
Condition: Solid Tumor
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I, Open-label, Fixed-Sequence Study to Evaluate the Effect of Multiple-dose
      Itraconazole or Rifampicin Capsules on the Single-dose PK Profiles of IMP4297 Capsules in
      Healthy Subjects
    

Detailed description: 
      Study design A Phase I, single-center, open-label, fixed-sequence study is designed to
      evaluate the effect of multiple-dose Itraconazole or Rifampicin Capsules on the single-dose
      PK profiles of IMP4297 Capsules in healthy Chinese subjects.

      32 subjects are planned to be enrolled (at least 12 subjects complete the study on one side).

      Two parallel groups will be planned in this study with 16 subjects enrolled in each group.
      Two cycles are set for each group. The first group will be given IMP4297 and Itraconazole in
      a fixed sequence (two dosing regimens); The second group will receive IMP4297 and Rifampicin
      in a fixed sequence (two dosing regimens).
    

Intervention name(s): IMP4297 40 mg; IMP4297 100 mg
Intervention type(s): Drug; Drug
Intervention description(s): IMP4297 40 mg: IMP4297 alone, Itraconazole + IMP4297; IMP4297 100 mg: IMP4297 alone, Rifampin + IMP4297
Other intervention name(s): Itraconazole; Rifampin
Intervention MeSH terms: Itraconazole; Rifampin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Study to Evaluate the Safety and Efficacy of CJ-12420 in Patients With Erosive Esophagitis
Condition: Erosive Esophagitis; GERD
MeSH terms: Esophagitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the optimal dose and administration methods of
      CJ-12420 in patients with erosive esophagitis by comparing the safety and efficacy of orally
      administered CJ-12420 to esomeprazole 40mg.
    


Intervention name(s): CJ-12420; Esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): Once daily, Oral administration; Once daily, Oral administration
Other intervention name(s): Undecided; Nexium
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: P-CAB; APA(Acid Pump Antagonist)
A Trial to Assess the Pharmacokinetics, Safety and Tolerability of Semaglutide in Healthy Chinese Subjects
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of the trial is to assess the pharmacokinetics of semaglutide (i.e. the way
      the drug is distributed in the body over a period of time) following once-weekly
      administration of semaglutide in healthy Chinese subjects. Different dose levels (0.5 and 1.0
      mg) will be investigated in this trial. Participants will be administered semaglutide or
      placebo once-weekly by subcutaneous injection (under the skin fold of the abdominal wall)
      using a pen injector with a very small, thin needle by the trial doctor at the trial site for
      13 weeks. The trial consists of 23 visits in total, including visit for screening and safety
      tests, visit for dose administration and blood sample collection. The total time of
      participation will be approximately 18-22 weeks depending on participant's individual visit
      schedule.
    


Intervention name(s): Semaglutide 0.5 mg; Placebo (semaglutide 0.5 mg); Semaglutide 1.0 mg; Placebo (semaglutide 1.0 mg)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A dose of 0.25 mg semaglutide gradually increased to 0.5 mg injected subcutaneously (under the skin) once weekly for 13 weeks.; A dose of 0.25 mg semaglutide placebo gradually increased to 0.5 mg injected subcutaneously (under the skin) once weekly for 13 weeks.; A dose of 0.25 mg semaglutide gradually increased to 1.0 mg injected subcutaneously (under the skin) once weekly for 13 weeks.; A dose of 0.25 mg semaglutide placebo gradually increased to 1.0 mg injected subcutaneously (under the skin) once weekly for 13 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of β-alanine Supplementation on Muscle Carnosine
Condition: Healthy
Study type: Interventional

Summary: 
      Carnosine is a natural acid buffering substance of muscle. The primary objective of this
      study is to test whether a nutritional supplement of beta-alanine enhances carnosine content
      in muscle.
    

Detailed description: 
      Volunteers will be randomized to receiving 3 nutritional supplements. Two supplements contain
      beta-alanine at different doses, the third supplement is a placebo.
    

Intervention name(s): placebo; beta-alanine; beta-alanine
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): daily; daily; daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: physical fitness; exercise; amino acid
Effect of Dietary Fat Cooking Blend on Energy Expenditure in Children
Condition: Childhood Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to test the effects of a cooking oil blend of dietary fats rich
      in medium chain triglycerides on energy expenditure and food intake in overweight and obese
      children.
    


Intervention name(s): Melt (test oil); Corn oil (control)
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Obesity; Dietary fat; Energy expenditure; Food intake
A Bioequivalence Study of Sunitinib Malate Capsules.
Condition: Gastrointestinal Stromal Tumors; Renal Cell Carcinoma; Pancreatic Neuroendocrine Tumor
MeSH terms: Carcinoma, Renal Cell; Neuroendocrine Tumors; Gastrointestinal Stromal Tumors
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open, two-period, two-sequence crossover trial design used to assess the
      pharmacokinetics and safety of Sunitinib Malate Capsules in healthy volunteers under fed
      condition, and compare the bioequivalence of Sunitinib Malate Capsules produced by Pfizer and
      Chia Tai Tianqing Pharmaceutical Group Co., Ltd, respectively.
    


Intervention name(s): Sunitinib malate capsules generic product; Sunitinib malate capsules reference product
Intervention type(s): Drug; Drug
Intervention description(s): Sunitinib is an inhibitor targeting multiple receptor tyrosine kinases (RTK).; Sunitinib is an inhibitor targeting multiple receptor tyrosine kinases (RTK).
Intervention MeSH terms: Sunitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
NEM® + KD PUR® Fish Oil Versus Placebo in Exercised-induced Joint Pain, Stiffness, & Cartilage Turnover in Healthy Men & Women
Condition: Exercise-induced Joint Pain; Exercise-induced Joint Stiffness; Exercise-induced Joint Cartilage Turnover
MeSH terms: Arthralgia
Study type: Interventional

Summary: 
      This study is intended to evaluate the effect of the dietary supplement combination of NEM®
      brand eggshell membrane + KD PUR® brand fish oil versus placebo in reducing exercise-induced
      joint pain, stiffness & cartilage turnover in healthy men & women. Half of the study
      participants will receive NEM + fish oil, once daily, orally while the other half of the
      study participants will receive placebo, once daily, orally while performing an exercise
      regimen every other day for two weeks.
    

Detailed description: 
      Moderate exercise can induce discomfort in joints when done infrequently or when done too
      intensely or for too long a period. This discomfort is often realized as either pain or
      stiffness in the joint that was the focus of the exercise. For example, one's knees will hurt
      after jogging for several miles, particularly if jogging for the first time. This study is
      intended to evaluate whether the combination of NEM® brand eggshell membrane + KD PUR® brand
      fish oil, commercially available as Move3™ can alleviate joint pain or stiffness, either
      directly following exercise or 12 hours post-exercise versus placebo. The study will also
      evaluate Move3's effect, on cartilage turnover via the cartilage degradation biomarker
      c-terminal cross-linked telopeptide of type II collagen (CTX-II). Participants will perform a
      minimum of 40 steps per leg utilizing an aerobics step at the clinical site. They will follow
      this exercise regimen on alternating days for 2 consecutive weeks. Changes in pain &
      stiffness (immediate & 12-hour) will be compared to both baseline and to the placebo group.
      Urine samples will also be collected at baseline and at the end of Week 1 & Week 2. The
      change in CTX-II from baseline will be compared to the placebo group.
    

Intervention name(s): Move3™ (NEM® brand eggshell membrane + KD PUR® brand fish oil); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dietary supplement combination for the support of joint health.; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: treatment versus placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: exercise-induced; joint pain; joint stiffness; cartilage turnover; CTX-II; exercise recovery
Metabolic Cost of Medicine Ball Training
Condition: Body Composition; Physical Fitness; Energy Expenditure; Resting Metabolic Rate
Study type: Interventional

Summary: 
      In this study, the investigators will be able to estimate the metabolic cost of several
      foundational medicine ball training exercises.
    

Detailed description: 
      Medicine ball training has become a popular cardiovascular training choice in fitness centers
      and athletic performance enhancement facilities. Despite widespread use and growing
      popularity, little is known about the metabolic demands of such a training method. Therefore,
      the purpose of this study was to quantify the cardiovascular and metabolic cost from various
      foundational medicine ball exercises in order to contribute to a better planning of exercise
      programs in the real world.

      Ten healthy young adults were assigned to execute fourteen bodyweight exercises (acute bout)
      of which seven exercises will be executed by throwing the medicine ball and seven exercises
      will be executed without a medicine ball throw. Anthropometric, metabolic, functional
      capacity and performance measurements were conducted at baseline. The metabolic cost was
      estimated from heart rate, blood lactate, resting oxygen uptake, exercise oxygen uptake, and
      excess post-exercise oxygen consumption measurements using a portable gas analyzer.
    

Intervention name(s): MB-TB; MB-NTB
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Training exercises with throwing a medicine ball will be performed for 30 seconds and the training volume will be consisted of 1 repetition.; Training exercises without throwing a medicine ball will be performed for 30 seconds and the training volume will be consisted of 1 repetition.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Other
Keywords: functional fitness training; Medicine ball Training; Energy Expenditure; Oxygen Consumption; Resistance Trianing