bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Whole-body Electromyostimulation on Golf Performance in Amateur Golfers
Condition: Athletic Performance
Study type: Interventional

Summary: 
      Golf is becoming increasingly popular in Germany. However, the biomechanical and motor
      challenge of golf should not be underestimated. Nevertheless, only very few amateur golfers
      carry out serious preparation and conditioning as part of a strength/stabilization program.
      The main argument for this limitation is the aspect of "limited time resources". A solution
      to this problem could therefore be the time-effective and highly individualizable whole-body
      electromyostimulation (WB-EMS) technology.

      The aim of the present study is to evaluate the effectiveness of 16 weeks of WB-EMS
      application on trunk stability and clubhead speed in male amateur golfers in a (randomized)
      controlled setting.
    


Intervention name(s): Electromyostimulation
Intervention type(s): Device
Intervention description(s): WB-EMS once per week 20 min for 16 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial with two study groups in parallel: (1) Whole body electromyostimulation (WB-EMS) or 16 weeks (b) non WB-EMS control
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Comparison of the Extent to Which the Drug Given as Two Different Capsule Sizes Becomes Available to the Body
Condition: Vasomotor Symptoms as a Sex Hormone-dependent Disorder in Women and Men
Study type: Interventional
Phase: Phase 1

Summary: 
      Researchers are looking for a new way to treat women who have symptoms by hormonal changes,
      like those that happen in women during menopause. These symptoms can include hot flashes,
      night sweats, and changes in blood pressure. These symptoms are caused by hormonal changes
      occurring during menopausal transition when women may have also changes in their monthly
      cycles. The menopausal transition most often begins between ages 45 and 55 and leads to
      menopause, a point in time 12 months after a woman's last period.

      The study drug, elinzanetant, was designed to treat symptoms caused by hormonal changes.
      Before a new treatment can be approved for people to take, researchers perform clinical
      trials to better understand how this treatment works and to investigate safety.

      The purpose of this study is to assess the blood levels of elinzanetant when given as 2
      capsules of dose A (what is intended for further research and future commercialization) and
      also to compare the blood levels when given as 3 capsules of dose B (what was used for
      research up to now). Furthermore, researchers want to find out if taking of elinzanetant on
      two time points leads to differences in blood levels of elinzanetant.

      This trial will be performed in healthy women aged 40 to 65 years.
    


Intervention name(s): Elinzanetant (BAY3427080) treatment A; Elinzanetant (BAY3427080) treatment B
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose; Single oral dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of a High Density Formula on Growth and Safety in Congenital Heart Disease Infants
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      The purpose of this study is to explore the effects of high density formula in early
      postoperative infants with congenital heart disease and to assess its safety.
    

Detailed description: 
      The number of infants born with CHD increases every year and most CHD infants are suffered
      with malnutrition.Recent studies have shown that increasing energy intake in CHD infants can
      improve their nutrition status.But there are no high qualified evidences supporting that high
      density formula can promote infants' nutrition status and ensure its safety. The hypothesis
      of the current study is that high density formula intake can increase infants'weight and it's
      safe.

      The current study adopts randomized,controlled intervention trial, gives high density
      formula(Infatrini,100kcal/100ml)to CHD infants in intervention group and normal density
      formula（Neocate,67kcal/100ml）in control group. Intervention begins when infants start enteral
      nutrition after operation and continues for 7days.
    

Intervention name(s): normal density formula (Necocate); high density formula(Infatrini)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): In control group,there are 32 infants; In intervention group,there are 32 infants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: high density formula; heart defects; infant
Pharmacokinetics of Salmeterol (Serevent®) After Inhalation With Metered Dose Inhaler (MDI) and Diskus® in Healthy Male Volunteers
Condition: Healthy
MeSH terms: Respiratory Aspiration
Study type: Interventional
Phase: Phase 1

Summary: 
      1. To compare the systemic drug exposure of 100 μg Serevent ® Diskus ® with that of 50 μg
           Serevent ® MDI with sufficient precision so that in combination with a second trial it
           can be demonstrated that the systemic drug exposure of a new formulation of salmeterol
           xinafoate is not superior to that of Serevent ® MDI

        2. To test a system of ordered null hypotheses regarding the exposure of two dose levels of
           Serevent ® Diskus ® and Serevent ® MDI

        3. To get data about the systemic drug exposure of 25 μg Serevent ® MDI and of 50 μg
           Serevent ® Diskus ®
    


Intervention name(s): Salmeterol Diskus low; Salmeterol Diskus high; Salmeterol MDI low; Salmeterol MDI high
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PF-06669571 In Subjects With Idiopathic Parkinson's Disease
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess safety, tolerability and pharmacokinetic data for multiple
      doses of PF-06669571 in subjects with idiopathic Parkinson's disease. In addition, this study
      will assess whether PF-06669571 is able to demonstrate superior efficacy compared with
      placebo in the treatment of the motor symptoms of idiopathic Parkinson's disease.
    


Intervention name(s): PF-06669571; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 milligram (mg) QD for 3 days followed by 3 mg QD for 4 days; Placebo
Intervention MeSH terms: PF-06669571
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Comparison of Two NN5401 Formulations Versus Insulin Glargine, All in Combination With Metformin 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 2

Summary: 
      This trial is conducted in Europe. The aim of this trial is to compare two NN5401 (SIAC,
      insulin degludec/insulin aspart) formulations with each other and with insulin glargine, all
      in combination with metformin in insulin naive subjects with type 2 diabetes.
    


Intervention name(s): insulin degludec/insulin aspart; insulin degludec/insulin aspart; insulin glargine; metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Formulation 1: Treat-to-target dose titration scheme, injection s.c., once daily; Formulation 2: Treat-to-target dose titration scheme, injection s.c., once daily; Treat-to-target dose titration scheme, injection s.c., once daily; Tablets, 1500-2000 mg/day
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Metformin; Insulin Glargine; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial to Assess a Co-formulation of an Insulin Analog and Pramlintide in Subjects With Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is a monocentric, randomised, double-blind, active comparator, controlled,
      3-period cross-over trial.
    

Detailed description: 
      In this monocentric, randomised, double-blind, active comparator, controlled, cross-over
      trial, each patient will be randomly allocated to a sequence of three treatments: one single
      dose of the co-formulation of insulin analog and pramlintide (also called ADO09),
      simultaneous separate injections of pramlintide and human insulin and one single dose of
      insulin lispro. To keep the blinding in this trial, a placebo injection will be given in
      addition to the ADO09 formulation and insulin lispro dose for a total of 2 injections per
      dosing visit. During each visit, meal test procedures will be performed and subjects will
      stay at the clinical centre until post-dose follow-up period has been terminated. IMP
      administration will be done subcutaneously immediately prior to test meal intake.
    

Intervention name(s): ADO09 formulation; Placebo; Symlin®; Humulin®; Humalog®
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subcutaneous injection of ADO09 formulation; Subcutaneous injection of 0.9% NaCl; Subcutaneous injection of pramlintide; Subcutaneous injection of human insulin; Subcutaneous injection of insulin lispro
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of ALGRX 3268 for Needlestick Pain in Children
Condition: Pain
MeSH terms: Needlestick Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      Minor needlestick procedures often cause significant pain and distress in children, yet
      interventions to reduce pain are used infrequently. ALGRX 3268 is a novel, single-use,
      prefilled, needle-free dispenser that immediately delivers powdered lidocaine into the
      epidermis and provides local analgesia in 2 to 3 minutes. The purpose of this prospective,
      randomized, double-blind, and placebo-controlled trial is to determine the efficacy and
      tolerability of ALGRX 3268 in children aged 3 to 18 years undergoing venipuncture. The trial
      will enroll a total of 306 children aged 3 to 18 years scheduled to undergo venipuncture of
      the back of the hand at a single study center.
    

Detailed description: 
      ALGRX 3268 (previously known as PowderJect® Dermal Lidocaine) is a system for needle-free,
      pain-free epidermal injection of lidocaine powder that provides local anesthesia within 3
      minutes to provide painless needle or catheter insertion for blood drawing. ALGRX 3268 is a
      single use disposable system, incorporating a drug cassette and gas cylinder into a single
      hand held device, with a button to actuate the system. This is a single center, randomized,
      double-blind, placebo (sham) controlled, single dose, parallel group study in pediatric
      subjects scheduled to undergo venipuncture. Three age groups are enrolled: 3-7 years, 8-12
      years, and 13-18 years. Within each age group, subjects are randomized to receive ALGRX 3268
      0.5 mg/20 bar or pressure matched placebo. Two to 3 minutes after administration of study
      treatment at the back of the hand, venipuncture is performed with either a
      needle/Vacutainer®, needle/syringe or "butterfly," at the discretion of the investigator.
      Subjects aged 3-7 are asked to rate the pain of venipuncture using the Wong-Baker FACES Pain
      Rating Scale, anchored at 0 for "no hurt" and 5 for "hurts worst." Subjects in oldest age
      group complete a 100 mm visual analogue scale (VAS), anchored at 0 for "no pain" and at 100
      for "extreme pain." Subjects in the middle group used both the Wong-Baker FACES scale and the
      VAS to rate the pain of venipuncture. Safety ratings of skin are completed 15, 30, and 60
      minutes after the procedure.
    

Intervention name(s): ALGRX 3268
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Needlestick pain; Venipuncture pain; Procedural pain
VERRARI - "Are Ventricular Arrhythmic Episodes Reduced by Rate Response in ICDs?"
Condition: Ventricular Fibrillation
MeSH terms: Ventricular Fibrillation
Study type: Interventional
Phase: Phase 4

Summary: 
      "The purpose of this study is to evaluate the influence of the rate response function of
      implantable cardioverter defibrillators (ICDs) on the frequency of ventricular arrhythmias in
      patients with an ICD."
    

Detailed description: 
      "Background: Studies have shown that bradycardia and irregular heart rates may increase the
      incidence of ventricular arrhythmias. Regularizing the heart rate and avoiding bradycardias
      by rate responsive pacing may be a way to reduce these arrhythmias.

      This is a prospective, open-label, randomized multicenter study. Inclusion criteria: Patients
      with an indication for an ICD according to the AHA/ACC-guidelines who get a rate response
      system and have more than 5 % rate adaptive pacing during a one month screening phase may be
      included if they have given written informed consent. Rate adaptive pacing must not be
      contraindicated, patients must be able to perform a 6 min walk test, must not be NYHA IV and
      should have a life expectancy of more than 18 months.

      Patients will be randomly assigned to 6 months of rate responsive pacing followed by 6 months
      of no rate responsive pacing, vice versa respectively. At 6 and 12 months follow ups, ICD
      stored data, arrhythmic episodes, medication, anamnesis, quality of life, 6 min walktest,
      echocardiographic parameters and optionally spiroergomatry will be evaluated and compared."
    

Intervention name(s): ICD
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety and Pharmacokinetics of Efinaconazole Topical Solution in Subjects With Mild to Severe Onychomycosis
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Safety and Pharmacokinetics (PK) of a once daily topical application of efinaconazole in the
      treatment of pediatric subjects with mild to severe onychomycosis of the toenails.
    

Detailed description: 
      This is an open label, single-arm study designed to evaluate the safety and PK of a once
      daily topical application of efinaconazole in the treatment of pediatric subjects with mild
      to severe onychomycosis of the toenails.
    

Intervention name(s): Efinaconazole
Intervention type(s): Drug
Intervention description(s): Solution
Intervention MeSH terms: Efinaconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Antrum Size, Glucagon-like Peptide 1 Levels and Glycemic Control After Sleeve Gastrectomy in Morbid Obese Diabetic Adolescents
Condition: Adolescent Obesity
MeSH terms: Pediatric Obesity
Study type: Observational

Summary: 
      Childhood obesity can adversely affect every organ and often has serious consequences.
      Compare the effect of transection at 2cm vs at 5cm from the pylorus during laparoscopic
      sleeve gastrectomy on the postoperative weight loss, glucagon-like peptide 1 levels and the
      glycemic control in morbid obese diabetic adolescents.
    

Detailed description: 
      This was a retrospective sub-analysis included 18 type 2 diabetic morbidly obese adolescents
      of both genders from a larger study (performed on 67 patients between December 2014 and
      December 2015) conducted at pediatric surgery unit, surgical department, Egypt. They were
      divided in 2 groups, done by 2 surgeons, group A (8 patients) the first stable line was at 2
      cm from the pylorus, and group B (10 patients) at 5 cm from the pylorus.
    

Intervention name(s): Laparoscopic sleeve gastrectomy
Intervention type(s): Procedure
Intervention description(s): Laparoscopic sleeve gastrectomy at 2 and 5 cm from the pylorus on the postoperative weight loss, GLP1 levels and the glycemic control in morbid obese diabetic adolescents.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        morbid obese diabetic adolescents
      
Biospecimen description: 
      glucagon-like peptide 1 HbA1c (glycated hemoglobin) body mass index
    
Keywords: Laparoscopic sleeve gastrectomy; obesity; adolescent; glucagon-like peptide 1; glycemic control; diabetes
Compassionate Use of Beraprost Sodium 314d Modified Release for Patients With Pulmonary Arterial Hypertension (PAH)
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to see if Lung LLC's new experimental formulation of the
      medicine Beraprost Sodium, called Beraprost Sodium 314d Modified Release (BPS-314d-MR), can
      improve the symptoms of pulmonary arterial hypertension (PAH) in patients. An experimental
      drug is one that has not been approved by the U.S. Food and Drug Administration for use in
      the general public. This research study is for patients who have pulmonary arterial
      hypertension (PAH) and have just completed taking part in an earlier research study and
      received an older experimental formulation of Beraprost Sodium, called Beraprost Sodium
      Modified Release (BPS-MR). That earlier study was being done to see if BPS-MR could improve
      their PAH.

      Patients may also be taking Tyvaso (treprostinil), Tracleer (bosentan), Letairis
      (ambrisentan), Adcirca (tadalafil) and/or Viagra or Revatio (sildenafil) to treat their PAH.
      The diagnosis of PAH means that the blood pressure in their lungs is higher than normal. The
      increased blood pressure in the lungs places a strain on the heart. The strain causes the
      heart to pump less blood into the lungs, causing shortness of breath and tiredness. The
      strain on the heart weakens the heart muscle making it less able to pump blood, a condition
      called heart failure. As heart failure develops, swelling in the feet and abdomen may occur.
    

Detailed description: 
      According to Lung LLC, and from my review of summary results contained within the most recent
      version of the BPS-314d-MR Investigators' Brochure I concur, BPS-314d- MR has been shown to
      have a similar safety and pharmacokinetic profile in healthy volunteers to BPS-MR. It is also
      my understanding that at an End of Phase II meeting in April of this year, FDA acknowledged
      Lung LLC's intention to continue the development of BPS-314d-MR by conducting a Phase III
      pivotal study in PAH patients. This study, BPS-314d-MR-PAH-302 was subsequently initiated
      this past June.

      In my opinion, and based upon the similarities of the two formulations, it is in the best
      interest of our patients to transition their treatment to BPS-314d-MR.

      Lung LLC has agreed to supply BPS-314d-MR for the patients.
    

Intervention name(s): BPS-314d-MR
Intervention type(s): Drug
Intervention description(s): 15-150 mcg po BID,
Other intervention name(s): Beraprost 314-d modified release
Intervention MeSH terms: Beraprost
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary Arterial Hypertension; prostacyclin; oral
RENABLATE Feasibility Study CS156 (EC12-02) Study of Catheter Based Renal Denervation to Treat Resistant Hypertension
Condition: Hypertension, Renal
MeSH terms: Hypertension, Renal; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The RENABLATE feasibility study is a prospective, multi-center, non-randomized feasibility
      study to evaluate the safety and effectiveness of the investigational multi-electrode
      ablation catheter and integrated ablation system to treat resistant hypertension.
    

Detailed description: 
      The RENABLATE feasibility study CS156 (EC12-02) is a prospective, multi-center,
      non-randomized feasibility study to evaluate the safety and effectiveness of renal artery
      sympathetic denervation using the investigational Celsius® ThermoCool® Renal Denervation (RD)
      Multi-electrode Ablation Catheter and integrated ablation system to treat resistant
      hypertension.
    

Intervention name(s): Celsius® ThermoCool® RD
Intervention type(s): Device
Intervention description(s): The investigational device is designed to transmit radiofrequency (RF) current to the electrodes for ablation purposes, specifically for the treatment of resistant hypertension by renal denervation.
Other intervention name(s): Multi-electrode Ablation Catheter
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Essential Hypertension; Renal Denervation; Vascular Disease; Renal Catheter Ablation; Primary Hypertension
Pesticides--Health Fertility and Reproductive Risk
Condition: Birth Defects; Miscarriages; Cancer
MeSH terms: Abortion, Spontaneous; Congenital Abnormalities
Study type: Observational

Summary: 
      This project is designed to establish whether pesticides or other environmental agents have a
      role in the excess birth defects identified in the Red River Valley of Minnesota. In this
      human study, laboratory based health parameters will be used to key in health survey data. In
      vitro data will be developed to mechanistic information. Concordant results among these study
      features will provide a weight of evidence approach.
    


Observational model: Defined Population
Time perspective: Other
Keywords: population studies; laboratory evaluation; hormone analysis; semen analysis; chromosome studies
An Study to Determine the Bioavailability of E2609 Tablets Compared to Capsules and the Effect of Food on Absorption
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a single-center, open-label, randomized, 3-treatment crossover study of
      single oral doses of an API-capsule formulation of E2609 under fasted conditions and a tablet
      formulation administered under fed and fasted conditions in healthy subjects.
    


Intervention name(s): E2609
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment