bioihbjkbjnl/mcl2 huggingface dataset:
Effects of a Scapular-focused Exercise Protocol
Condition: Rotator Cuff Syndrome of Shoulder and Allied Disorders
MeSH terms: Syndrome
Study type: Interventional

Summary: 
      Background: Current clinical practice still lacks consistent evidence in the physiotherapy
      management of Rotator cuff related pain syndrome (RCS). The purpose of this trial was to
      compare the effectiveness of a scapular-focused treatment with and without real-time
      electromyographic biofeedback (EMGBF) to a control therapy in patients with RCS.

      Methods: 60 patients with RCS were divided into three groups: scapular-focused exercise
      protocol group (P_G n=20), scapular-focused exercise protocol with EMGBF group (P+EMGBF_G
      n=20) and control therapy group (CT_G n=20). Values of pain and function [Shoulder Pain and
      Disability Index (SPADI) questionnaire, complemented by the Numeric Pain Rating Scale (NPRS)
      and Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire], scapular stabilizer
      neuromuscular control (SSNC), scapular stabilizer activation onset (SSAO), dynamic scapular
      alignment, range of motion (ROM) and glenohumeral flexor and abductor muscle strength (GMS)
      were assessed at baseline and after 6-weeks and compared within and between groups.
    

Detailed description: 
      In order to advance the understanding of the value of scapular-focused exercise for rotator
      cuff related syndrome, a new trial was designed with the main objective of comparing pain and
      function outcomes between three different treatment protocols for patients with RCS:

      P_G - Scapular-focused exercise protocol without electromyographic biofeedback (EMGBF)
      P+EMGBF_G - Scapular-focused exercise protocol supported by real-time EMGBF CT_G - Control
      therapy group with manual therapy (glenohumeral joint physiologic and accessory mobilization)
      , massage to reduce upper trapezius (UT) stiffness, and shoulder rotation strengthening into
      external rotation Every outcomes was assessed at the beginning of treatment, and then, weekly
      until completed 6 weeks of treatment.
    

Intervention name(s): Scapular-focused exercise protocol with EMGBF; Control Therapy; Scapular-focused exercise protocol without EMGBF
Intervention type(s): Other; Other; Other
Intervention description(s): Scapular-focused exercises, based on the dos Santos et al (2021) protocol with the aid of the electromyographic biofeedback; manual and exercise therapy; Scapular-focused exercises, based on the dos Santos et al (2021) protocol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: scapula neuromuscular activity and control; rotator cuff related pain syndrome; scapular dyskinesis; electromyographic biofeedback; control therapy; pain and function
Bioequivalence of a Zanubrutinib Tablet Compared to Capsules in Healthy Adult Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the bioequivalence of a zanubrutinib tablet compared to capsules in
      healthy adult participants.
    


Intervention name(s): Zanubrutinib
Intervention type(s): Drug
Intervention description(s): Administered as a tablet or capsule
Other intervention name(s): BGB-3111; Brukinsa
Intervention MeSH terms: Zanubrutinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
IT-Based Training in Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Prospective, randomized, single center, controlled intervention study to investigate the
      effect of a systematic combined personal and IT-based training on the outcome of patients
      with metabolic syndrome.
    

Detailed description: 
      The study settles in the field of primary prevention and aims to change lifestyle of patients
      with metabolic syndrome with a new combination of personal and IT-based training specially
      designed für obese people with risk factors. Procedures that are similar for all participants
      are summarized in a training program whereas individual aspects of physical activity like
      initial education and exercise tests are still performed by doctors and trainers. Before and
      after three months of training anthropometric parameters, laboratory and exercise capacity
      are examined and analyzed. The intervention group is characterized by a predetermined
      exercise program whereas the control group is allowed to practise without detailed
      instructions. The practicability and the effect on health status of the combined personal and
      IT-based training in the intervention group is compared with the independent training of the
      control group. After 6 months and again after 12 months the measurements are repeated to
      evaluate a lasting effect of the program.
    

Intervention name(s): Combined 3-monthly endurance and strength training
Intervention type(s): Other
Intervention description(s): Combined 3-monthly endurance- (3x/week) and strength training (2x/week) with moderate beginning and continuous increase of volume, duration and intensity, orientated on metabolic equivalents (MET).
Main sport: walking, walk and cycling. Addition with other activities are possible up to once a week to achieve the basal metabolism
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: metabolic syndrome; physical activity; overweight; malnutrition; prevention
Hormones and Decision Making
Condition: Dyssocial Behavior
MeSH terms: Antisocial Personality Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      An investigation of the neuropsychological processes underlying ethical decision making.
    

Detailed description: 
      This study will investigate the influence of reward sensitivity on cheating behavior via
      experimental manipulation of reward sensitivity using testosterone.
    

Intervention name(s): testosterone propionate; 0.5% cholorbutanol, saline
Intervention type(s): Drug; Drug
Intervention description(s): 1mg/0.1mL solution, to be administered intranasally; 125 mg 0.5% cholorbutanol, 50mg saline
Other intervention name(s): Testovis
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Study in Cat-Allergic Patients With Asthma to Evaluate the Efficacy of a Single Dose of REGN1908-1909 to Reduce Bronchoconstriction Upon Cat Allergen Challenge
Condition: Cat Allergy; Mild Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to evaluate the prophylactic efficacy of REGN1908-1909 (anti-Fel d
      1) administered as a single dose on day 1 in cat-allergic asthmatic patients not living with
      a cat in the prevention of a Controlled Cat Allergen Challenge-induced early asthmatic
      response (EAR) assessed by measures of lung function (FEV1) compared to placebo-treated
      patients.

      Secondary Efficacy Objectives:

        -  To evaluate the prophylactic efficacy of REGN1908-1909 administered as a single dose on
           day 1 in cat-allergic asthmatic patients not living with a cat, in the prevention of a
           Controlled Cat Allergen Challenge-induced: Allergic rhinitis and Ocular symptoms

        -  To evaluate the prophylactic efficacy of REGN1908-1909 administered as a single dose on
           day 1 in cat-allergic asthmatic patients not living with a cat to increase the exposure
           to cat allergen, measured as a product of minute ventilation and time, required to
           induce EAR in a Controlled Cat Allergen Challenge as compared to placebo patients

      Secondary Safety Objective:

        -  To evaluate the safety and tolerability of REGN1908-1909 vs. placebo in patients with
           cat allergen-triggered asthma
    


Intervention name(s): REGN1908-1909; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single subcutaneous (SC) dose of REGN1908 and REGN1909; Single subcutaneous (SC) dose of matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Autologous Platelet-rich Plasma in Uterine Wound Healing
Condition: Cesarean Section Complications
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to evaluate the efficacy of intramuscular autologus platelet rich
      plasma on uterine wound healing after primary cesarean section
    

Detailed description: 
      110 pregnant female undergoing primary prelabor CS will be randomized to two groups group
      A)autologus PRP will be prepared from participant venous blood collected from the
      participants' arm into a syringe primed with ACD-A. then it will be injected into uterus
      after closing uterine incision . Injection sites will be selected near the incision at evenly
      20 different sites

      group B)normal saline 0.9 will be injected into uterus after closing uterine incision .
      Injection sites will be selected near the incision at evenly 20 different sites.
    

Intervention name(s): autologus platelet rich plasma; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 55 participant unergoing prelabor primary CS will receive intramyometrial injection of PRP after closure of uterine incision; 55 participant unergoing prelabor primary CS will receive intramyometrial injection of normal saline after closure of uterine incision
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
A Study of RO6870868 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, placebo-controlled study will evaluate the safety,
      tolerability, pharmacokinetics of RO6870868 in healthy volunteers. Subjects will be
      randomized to receive single ascending doses of either RO6870868 or placebo, with or without
      food.
    


Intervention name(s): RO6870868; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single ascending doses; Single ascending doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced NSCLC Metastatic Non-small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer; Efficacy
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      A phase III trial has demonstrated that in advanced non-small cell lung cancer (NSCLC)
      cisplatin/ pemetrexed provides similar efficacy with better tolerability and more convenient
      administration than cisplatin/gemcitabine. Moreover,this trial showed survival differences
      based on histologic type. The investigators want to research some biomarkers that can predict
      clinical outcomes.
    


Intervention name(s): cisplatin, dexamethasone,vitamin B12, folic acid; cisplatin, gemcitabine
Intervention type(s): Drug; Drug
Intervention description(s): Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment; cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
Intervention MeSH terms: Folic Acid; Vitamin B 12; Dexamethasone; Cisplatin; Gemcitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Safety, Tolerability and Amount of EI-1071 in Blood in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a first-in-human study to determine the safety, tolerability, and pharmacokinetics
      of EI1071 after single and multiple doses in healthy volunteers.
    

Detailed description: 
      This phase 1 first-in-human study was designed to assess the safety, tolerability, and
      pharmacokinetics of single and multiple doses of EI1071 when administered to healthy adult
      volunteers. This was a randomized, double-blind, placebo-controlled, ascending dose,
      multi-cohort trial. The study was conducted in two phases: a single ascending dose (SAD)
      phase, followed by a multiple ascending dose (MAD) phase. Approximately 58 healthy volunteers
      enrolled in SAD and MAD cohorts (34 in SAD; 24 in MAD). In SAD, participants in Cohorts 1 to
      5 received one dose of EI-1071 or placebo. In MAD, participants in Cohorts 1 and 2 received
      multiple doses of EI-1071 or placebo for 14 consecutive days. Safety, tolerability, and PK
      profile of EI-1071 were assessed.
    

Intervention name(s): EI-1071; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): EI-1071 Tablet(s); Matching Placebo Tablet(s)
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CSF1R Inhibitor; Safety; Tolerability; Pharmacokinetics; EI1071
Single Oral Dose of Dexamethasone Versus Five Days of Prednisone in Adult Asthma
Condition: Asthma; Reactive Airway Disease
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      This study seeks to compare the effectiveness of a single dose of oral dexamethasone versus 5
      days of oral prednisone in the treatment of mild to moderate asthma exacerbations to prevent
      relapse with an unscheduled return visit to a health care provider for additional asthma
      treatment within 14 days. The investigators hypothesize that the two treatments will be
      equally effective in relapse prevention.
    

Detailed description: 
      Dexamethasone and Prednisone are both systemic corticosteroids. The study will compare a
      single dose of oral dexamethasone to 5 days of oral prednisone in the treatment of asthma.
      Oral corticosteroids are commonly prescribed following an asthma exacerbation as it has been
      demonstrated that these medications prevent relapse.

      Oral prednisone is the most common corticosteroid prescribed for asthma relapse prevention.
      The half life is around 4 hours and is typically prescribed for minimally 5 days.

      The study is evaluating the efficacy of a single dose of dexmethasone. The drug's efficicacy
      has been shown to be longer acting and up to 72 hours. A single dose would eliminate the need
      for a prescription for a drug like prednisone to hopefully improve compliance.
    

Intervention name(s): Dexamethasone; Prednisone
Intervention type(s): Drug; Drug
Intervention description(s): Dexamethasone 12mg PO single dose x 1 Placebo 1 capsule PO for 4 days; Prednisone 60mg PO q day for 5 days
Other intervention name(s): Decadron; Glucocorticoid
Intervention MeSH terms: Dexamethasone; Prednisone; Glucocorticoids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Relapse; Corticosteroids
Perioperative Three Dimensional Right Ventricular Function
Condition: Heart Diseases
MeSH terms: Heart Diseases
Study type: Observational

Summary: 
      This study addresses the influence of anesthesia induction, ventilation and influence of
      cardiac surgical procedures and cardio-pulmonary-bypass on right ventricular function.
      Influence on patient outcome is also studied. Three dimensional echocardiography is applied.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult cardiac surgical patients
Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2, open label, randomized study will investigate the virologic benefit, clinical
      efficacy, safety, and tolerability of amantadine and ribavirin with oseltamivir (TCAD) versus
      oseltamivir monotherapy for the treatment of all strains of influenza A in immunocompromised
      adult and pediatric subjects.
    


Intervention name(s): Oseltamivir Phosphate; ADS-8902
Intervention type(s): Drug; Drug
Intervention description(s): Oseltamivir Phosphate, q8h; Amantadine Hydrochloride, Ribavirin administered with Oseltamivir Phosphate, q8h
Other intervention name(s): Tamiflu; Amantadine Hydrochloride; Rebetol®; Tamiflu®
Intervention MeSH terms: Oseltamivir; Amantadine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Influenza; Immunocompromised; HIV; History of transplant
Evaluation of the Ocular Safety of Calcium Formate in Normal, Healthy Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, single center, open-label study of the dietary supplement calcium formate
      in normal, healthy female subjects. The purpose of the study is to determine whether daily
      use of calcium formate is safe and whether it accumulates in the eye.
    

Detailed description: 
      This is a Phase I, single center, open-label study of the dietary supplement calcium formate
      in normal, healthy female subjects. The purpose of the study is to determine whether daily
      use of calcium formate is safe and whether it accumulates in the eye.
    

Intervention name(s): calcium formate
Intervention type(s): Drug
Intervention description(s): Calcium formate - Each uncoated white tablet will contain 650 mg of calcium formate, (equivalent to 200 mg elemental calcium). Nephro-Tech, LLC, will formulate and provide the calcium formate tablets for the study.
Intervention MeSH terms: Calcium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Ascending Dosed of HSK36273 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, Phase 1, placebo and positive-controlled, randomized, partial-blind,
      integrated, sequential ascending dose / multiple ascending dose study.The safety,
      tolerability, pharmacokinetics and pharmacodynamics of multiple continuous IV infusion
      ascending doses of HSK36273 in healthy volunteers will be evaluated.
    


Intervention name(s): HSK36273; Placebo; Heparin sodium injection
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Multiple continuous IV infusion ascending doses for 5 days; Matching placebo; Matching positive control
Intervention MeSH terms: Heparin; Calcium heparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: HSK36273; healthy; Phase I; continuous IV
Investigation to Evaluate the Clinical Safety and Effectiveness of WET® Gel
Condition: Nose Dry Feeling of
Study type: Interventional

Summary: 
      The objective of the investigation is to assess the clinical safety and effectiveness of WET®
      gel in the treatment of nasal dryness, following maximum two weeks of treatment.
    

Detailed description: 
      The objective of the project is to perform a post marketing clinical study to confirm safety
      and clinical effectiveness of WET® gel in the treatment of nasal dryness.

      This investigation will be carried out following the CE marking of the WET® gel device and is
      mainly intended to answer questions relating to clinical safety or performance (i.e. residual
      risks) of the device when used in accordance whit its approved labelling.

      The study is also aimed at defining the optimal dose regimen of WET® gel.
    

Intervention name(s): WET® gel
Intervention type(s): Device
Intervention description(s): In each application, a puff should be administered in each nostril every two seconds, with minimal inspirations, up to a sensation of lubrication in the external conduct is perceived. Then the patient should proceed with short inspirations and light touching of ala of the nose, to favour the distribution of the gel. A maximum of 4 erogations (2/nostril) is allowed in each application session.
Other intervention name(s): WET® gel, containing Hydeal-D®, an ester of hyaluronic acid
Intervention MeSH terms: Hyaluronic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: dryness; nasal; gel; hyaluronic acid
Lisdexamfetamine Dimesylate in the Treatment of Adult ADHD With Anxiety Disorder Comorbidity
Condition: Adult Attention Deficit Hyperactivity Disorder (ADHD) With Co-occuring Anxiety and Depressive Disorders
MeSH terms: Anxiety Disorders; Depressive Disorder; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      1. To evaluate the safety, and efficacy of Lisdexamfetamine dimesylate in the treatment of
           outpatients with DSM-IV ADHD with anxiety and depressive disorder comorbidity, as well
           as to evaluate the effects on quality of life .

        2. To evaluate the efficacy of Lisdexamfetamine dimesylate in the treatment of anxiety and
           depressive disorders which commonly occur with ADHD.

        3. To examine the potential relationship between telomere length and Adult ADHD with
           comorbidity and the potential effect of treatment response.

        4. To examine the potential associations with specific genes and Adult ADHD.
    


Intervention name(s): Lisdexamfetamine Dimesylate; placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Vyvanse
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; ADD; Anxiety; Anxiety Disorders; Depression; Attention; Attention Deficit
Study of LY3039478 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study involves one dose of LY3039478 given by mouth followed by an intravenous infusion
      (IV) (via a tube linked to a small needle in the vein) of LY3039478. The results of this
      study will help to answer the following research questions:

        -  How much LY3039478 gets into the blood stream when given by mouth as a capsule compared
           to when given by an IV

        -  How long it takes the body to remove the study drug

        -  The safety of LY3039478 and any side effects that might be associated with it

      Participation in the study is expected to last up to 7 weeks. There will be screening, a
      single study period, and a follow-up.
    


Intervention name(s): LY3039478; 3C 15N 2H-LY3039478 IV
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered IV
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science