bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Red Spinach Extract on Physical Performance Following Chronic Resistance Training in Trained Males
Condition: Sports
Study type: Interventional

Summary: 
      Red Spinach is a natural food which is a rich source of nitrates, which are beneficial in
      hemodynamics, cardiovascular function, and have natural hypotensive and antianginal effects .
      In recent research, Red spinach extract has been shown to be beneficial in acute exercise
      performance. However, currently it is unclear how these acute increases in performance may
      translate to long term training adaptations.

      This research study is designed to measure the effects of red spinach extract (RSE) on
      markers of physical performance, body composition, and health following chronic resistance
      training and anaerobic exercise.
    

Detailed description: 
      The investigators aim to measure muscle strength, athletic performance, body composition, and
      muscle size in two groups of adults before and after 11 weeks of intervention in a
      randomized, double blinded study. One group (n=15 ) will receive an intervention of
      resistance exercise and a Red Spinach Extract supplement, and the other group (n=15) will
      receive resistance exercise and a placebo (maltodextrin).
    

Intervention name(s): Placebo; Red Spinach Extract (RSE)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Oral placebo capsules will be taken consisting of maltodrextrin daily for 11 weeks; Oral capsules containing 2g of Red Spinach Extract will be consumed daily for 11 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Improvement Adherence to Clinical Practice Guidelines Using the Clinical Decision Support System in Patients With Hypertension and Atrial Fibrillation
Condition: Atrial Fibrillation; Arterial Hypertension
MeSH terms: Hypertension; Atrial Fibrillation
Study type: Interventional

Summary: 
      The Clinical Decision Support Systems (CDSS) based on real clinical data and its own
      algorithms can help to make the right choice according to guidelines. The goal of the
      INTELLECT II study is to investigate treatment adherence to guidelines/science-based medicine
      and its impact on patient outcomes into two groups of doctors, clinical centers with standard
      care of treatment (control), and clinical centers using CDSS (active).
    

Detailed description: 
      Hypertension and atrial fibrillation are 2 important public health priorities. There is a gap
      between evidence-based best management and actual clinical practice. To decrease this gap,
      clinical practice guidelines (CPGs), based on available evidence are employed. Clinical
      decision support system ("MedicBK") is a computer-based program that analyzes published
      evidence and provides prompts and reminders to assist health care providers in implementing
      clinical guidelines and science-based medicine at the point of care. The INTELLECT II trial
      is designed as a multicenter, cluster-randomized, single-blind, controlled study with blinded
      outcome assessment. Approximately 10 centers from Russia will be enrolled. Centers managing
      patients with symptomatic atrial fibrillation and/or hypertension will be randomized to
      either patient management with aid of CDSS ("MedicBK") or standard care.
    

Intervention name(s): CDSS ("MedicBK")
Intervention type(s): Other
Intervention description(s): Clinical decision support system ("MedicBK") is a computer-based program that analyzes published evidence and provides prompts and reminders to assist health care providers in implementing clinical guidelines and science-based medicine at the point of care.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: multicenter, cluster-randomized, single-blind, controlled study with blinded outcome assessment.
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: clinical practice guidelines; Clinical Decision Support Systems; adherence to guidelines; evidence-based medicine
The Effect of Escitalopram in PCOS
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      In a randomized study the investigators aim to characterize the effect of antidepressive
      medicine on quality of life, body composition, adrenal activity and glucose metabolism in
      PCOS.

      PCOS is a common endocrine disorder characterized by adrenal and ovarian hyperandrogenaemia,
      anovulation and insulin resistance. The pathogenesis of PCOS may be described by a vicious
      cycle involving insulin resistance which stimulates ovarian and adrenal hyper androgenaemia
      and leads to abdominal obesity, causing increased risk for diabetes and cardiovascular
      disease. Adrenal hyperactivity is associated with depression. Antidepressive medicine may
      normalize pituitary-adrenal activity and in animal studies antidepressive medicine improved
      adrenal hyperactivity and normalized insulin sensitivity.
    

Detailed description: 
      Clinical study Effects of antidepressive treatment on quality of life, insulin sensitivity
      and cortisone metabolism in PCOS.

      Hypothesis Participants with PCOS have increased hypothalamic-pituitary-adrenal activity
      compared to healthy women. Antidepressive treatment improves quality of life, cortisone and
      glucose turnover.

      Design A randomized controlled study in 40 PCOS patients who are treated with cipralex or
      placebo for 12 weeks. Before and after the treatment period the patients have a physical
      examination, a whole body dexa scan and fasting blood samples. Hypothalamic-pituitary-adrenal
      is measured by 24 hour samples of cortisone metabolites, 60 minutes ACTH test with basal and
      stimulated measurement of cortisone and 17-hydroxyprogesterone. Glucose metabolism is
      examined by oral glucose tolerance test. Biopsies of muscle and fat are also performed.
    

Intervention name(s): Escitalopram 20 mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Antidepressant
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety of and Immune Response to a DNA HIV Vaccine (VRC-HIVDNA009-00-VP) in HIV Infected Individuals With Acute HIV Infection
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate whether the HIV vaccine VRC-HIVDNA009-00-VP will be
      safe in individuals who started antiretroviral therapy during acute HIV-1 infection. The
      study will also test whether the vaccine can increase the immune system function in these
      participants.
    

Detailed description: 
      Highly active antiretroviral therapy (HAART) has greatly improved mortality and morbidity
      rates associated with HIV and AIDS. However, many HIV-1 infected individuals are unable to
      access HAART. It is therefore important to develop a safe and effective therapeutic vaccine
      to improve immune control of viral replication and reduce the need for antiretroviral
      medication. This study will evaluate the safety and immunogenicity of the HIV-1 DNA vaccine
      VRC-HIVDNA009-00-VP in treating HIV-1 infected individuals who initiated antiretroviral
      therapy during acute infection. This study will involve a supervised treatment interruption
      (STI) in order to determine whether therapeutic vaccination results in improved immune
      control of viral replication.

      Participants in this study will be randomly assigned to receive either the therapeutic
      vaccine or placebo in addition to their regular HAART regimens. During the first part of the
      study, participants will receive 4 vaccinations at Weeks 0, 4, 8 and 24. All individuals
      completing the therapeutic vaccination phase (defined as completing at least 3 immunizations,
      including the Week 24 immunization) will be given the opportunity to participate in the
      second part of the study and undergo a supervised discontinuation of HAART. At Week 30, these
      participants will discontinue all antiretroviral treatment and will be closely monitored.
      Participants will restart HAART if they experience a significant decline in their CD4 count,
      an increase in their viral loads, or if their physicians recommend they resume HAART. At Week
      52, all other participants can restart HAART at the discretion of their primary physician.

      21 study visits will occur over a period of 52 weeks. After Week 52, monthly study visits
      will occur through Week 72. Study visits will last approximately two hours and will include
      physical exams and blood and urine collection.
    

Intervention name(s): VRC-HIVDNA009-00-VP
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Acute Infection; Treatment Experienced; Treatment Interruption; HIV Therapeutic Vaccine
Investigation of Pharmacodynamic Characteristics of Explorative Formulation of Insulin Degludec in Male Subjects With Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate the
      pharmacodynamic (the effect of the investigated drug on the body) of insulin degludec
      (insulin 454), an explorative formulation, not similar to the proposed commercial
      formulation, under single-dose and steady-state conditions in male subjects with type 1
      diabetes.
    


Intervention name(s): insulin degludec
Intervention type(s): Drug
Intervention description(s): Administered subcutaneously (s.c., under the skin)
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluating of the Safety, Pharmacokinetics and Pharmacodynamics of QL1205 and Lucentis® in Patients With Wet AMD
Condition: Wet Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, two-group parallel, positive-controlled clinical Phase I
      trial comparing the safety, pharmacokinetics and pharmacodynamics of QL1205 and Lucentis® in
      patients with wet age-related macular degeneration.
    

Detailed description: 
      This is a phase I, randomized, double-blind, two-group parallel, positive-controlled clinical
      trial at four centers.

      The primary objective is to assess the initial clinical safety of intravitreal injection of
      QL1205 or Lucentis® in patients with wet age-related macular degeneration (wet-AMD).

      The secondary objective are to assess the initial clinical effectiveness and pharmacokinetic
      characteristics of intravitreal injection of QL1205 or Lucentis® in patients with wet
      age-related macular degeneration (wet-AMD).

      Subjects would sequentially enrolled according to the protocol in one of two cohorts.Subjects
      would receive a single 0.5mg of QL1205 or Lucentis® once a month for three months through
      vitreous injection.
    

Intervention name(s): lucentis; QL1205
Intervention type(s): Drug; Drug
Intervention description(s): intravitreal injection of 0.5 mg (0.05 ml), Q4W, continuous administration for 3 times (D1, D29, D57); intravitreal injection of 0.5 mg (0.05 ml), Q4W, continuous administration for 3 times (D1, D29, D57)
Other intervention name(s): Ranibizumab Injection; Ranibizumab Injection
Intervention MeSH terms: Ranibizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Laparoscopic Cholecystectomy in Management of ACC Within Versus After 3 Days
Condition: Acute Calculous Cholecystitis
MeSH terms: Cholecystitis; Acalculous Cholecystitis; Cholecystitis, Acute
Study type: Interventional

Summary: 
      This study was aimed to assess the outcome of laparoscopic cholecystectomy in acute calculous
      cholecystitis in terms of conversion rates, postoperative complications and length of
      hospital stay within and after 3 days of symptoms onset.
    

Detailed description: 
      The study aims to evaluate the safety and competency of laparoscopic cholecystectomy as
      surgical management of acute calculous cholecystitis within and after 72h of symptom onset.

      This study included 62 patients with acute calculous cholecystitis. Patients are divided into
      2 study groups by the time of laparoscopic cholecystectomy comparing to the onset of symptoms
      and categorized as Group A & B. Immediate laparoscopic cholecystectomy is performed in Group
      A. while late laparoscopic cholecystectomy is performed in Group B. Patients in both groups
      monitored since admission, during operations, and along the postoperative period.
    

Intervention name(s): Laparoscopic cholecystectomy
Intervention type(s): Procedure
Intervention description(s): The use of laparoscopic cholecystectomy in management of acute calculous cholecysitits
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 62 patients with acute calcular cholecystitis are divided into 2 study groups by the time of laparoscopic cholecystectomy comparing to onset of symptoms
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute calculous cholecystitis; Laparoscopic cholecystectomy; Early laparoscopic cholecystectomy; Late laparoscopic cholecystectomy
PK and Food Effect of Pregabalin Study After Dosing in Healthy Male Volunteers
Condition: Peripheral Neuropathy Pain
MeSH terms: Peripheral Nervous System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the pharmacokinetics of Pregabalin controlled release formulation
      after multiple dosing as compared to Pregabalin immediate release formulation and the food
      effect of high fat diet after single dosing in healthy male volunteers.
    

Detailed description: 
      Cohort 1 study is to assess the PK of Pregabalin controlled release formulation as compared
      to Pregabalin immediate release formulation. Cohort 1 subjects will be admitted to the clinic
      at Day 1. All subjects will receive multiple dosing for three days of YHD1119 or Pregabalin
      IR and will remain in the clinic until completion of all assessment on Day 19 including
      collection of PK sample. The treatment periods were separated by a washout period (10-17
      days).

      Cohort 2 study is to assess the food effect of high fat diet after single dosing. Cohort 2
      subjects will be admitted to the clinic at Day -1. All subjects will receive a single dose of
      YHD1119 and will remain in the clinic until completion of all assessment on Day 9 including
      collection of PK sample. The treatment periods were separated by a washout period (7-14
      days).
    

Intervention name(s): YHD1119; Lyrica
Intervention type(s): Drug; Drug
Intervention description(s): 2 by 2; 2 by 2
Other intervention name(s): Pregabalin 300mg; Pregabalin 150mg
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase IC Study of Safety and PK of SQ109 300mg Daily
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Healthy male and female volunteers will be given SQ109 300mg daily for 14 days to assess the
      safety and tolerability and pharmacokinetics.
    

Detailed description: 
      This is a Phase 1C randomized, placebo controlled, double-blinded, in-patient trial of a
      single oral dose of 300 mg of SQ109 given daily for 14 consecutive days to evaluate the
      safety, tolerability and pharmacokinetics of SQ109 in normal healthy male and female subjects
      18-45 years of age.

      Each subject will receive 300 mg of SQ109 or placebo.
    

Intervention name(s): Placebo; SQ109
Intervention type(s): Other; Drug
Intervention description(s): Placebo given orally, daily for 14 consecutive days; A single oral dose of 300 mg of SQ109 given daily for 14 consecutive days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tuberculosis
FMT in the Treatment of IBS
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      52 adult IBS patients were recruited. 50% were given a fecal microbiota transplantation in
      colonoscopy and 50% were given an FMT made of their own feces as placebo. follow up time was
      1 year after FMT.
    

Detailed description: 
      52 adult IBS patients of any subgroup(IBS-D, IBS-C or IBS-M), were recruited and given an FMT
      in colonoscopy. Neither the patient nor the care taking personnel did know in which group the
      patients belonged to. The patients were screened with fecal samples for 16RNA sequencing and
      they were repeatedly done IBS-SSS questionnaire and questionnaires for quality of life and
      psychical condition. Follow up time was 1 year after the colonoscopy.
    

Intervention name(s): Fecal Microbiota Transplantation (FMT); Placebo
Intervention type(s): Other; Other
Intervention description(s): Fecal suspension administered in colonoscopy into the cecum of the patient.; As a placebo a fecal suspension made of patients own feces is administered into the cecum of the patient in colonoscopy.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo controlled trial. 50% of patients received autologous FMT as placebo and 50% received FMT from a healthy donor.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Stryker Triathlon Total Knee System for Total Knee Arthroplasty Implanted Using Shapematch Cutting Guides:Sub-Study A
Condition: Arthroplasties, Replacement, Knee
Study type: Interventional

Summary: 
      This is a prospective, non-randomized, study of the clinical outcomes of participants that
      receive the Stryker Triathlon® Total Knee System for Total Knee Arthroplasty implanted using
      ShapeMatch® Cutting Guides.
    

Detailed description: 
      This is a prospective, non-randomized, study of the clinical outcomes of participants that
      receive the Stryker Triathlon® Total Knee System for Total Knee Arthroplasty implanted using
      ShapeMatch® Cutting Guides. Sub-study A aims to quantify the reproducibility of
      intra-operatively positioning the cutting guides onto the affected femoral and tibial joint
      surfaces.
    

Intervention name(s): Shapematch Cutting Guides
Intervention type(s): Device
Intervention description(s): Participants will undergo pre-operative assessment using MRI of the affected limb. At the time of surgery, a repeated-measures methodology will be implemented in which the position of the femoral and tibial cutting guides will be measured using the Navigation system. The same surgeon will position each cutting guide a total of 3 times for each patient. Multiple participants will be assessed by each surgeon. No bone cuts will take place using the patient-specific cutting guides. After the study-specific measurements have been taken, the total knee procedure will resume using the Navigation system and associated instruments. No post-operative evaluations will be undertaken as part of this sub-study
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Effects of a Novel Dietary Microalgae Based Ingredient on Muscle Recovery and Endurance Capacity
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this investigation is to examine the effects of consuming a new dietary
      microalgae based supplement vs. placebo on neuromuscular function, energy utilization,
      soreness, perceptual wellness, swelling, and markers of muscle damage and inflammation in
      healthy young men before and after an acute exercise-induced muscle damage protocol (downhill
      running), and influence on endurance capacity after prolonged consumption.
    


Intervention name(s): MicAlgae; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 months of supplementation with an innovative microalgae based ingredient; 2 months of supplementation with a placebo (Maltodextrin)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: recovery; muscle endurance; exercise capacity; microalgae; inflammation
Study to Investigate Safety and Tolerability of BI 1744 CL in Free Dose Combination With Tiotropium Bromide Both Administered by Respimat® in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate safety and tolerability of single, inhaled doses (2.5 μg, 5 μg, 10 μg,
      20 μg and 40 μg) of BI 1744 CL in free dose combination with tiotropium bromide 5 μg (for
      doses up to and including 20 μg BI 1744 CL) and 10 μg (for doses of 20 μg and 40 μg BI 1744
      CL), both administered by Respimat® in healthy male volunteers. Also, to investigate the
      pharmacokinetics of BI 1744 BS and tiotropium bromide in such combinations, to explore their
      dose proportionality, and to explore the pharmacodynamic effects of the treatments on
      selected metabolic and respiratory parameters
    


Intervention name(s): BI 1744 CL; Placebo; Tiotropium bromide
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Bromides; Tiotropium Bromide; Olodaterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Extracorporeal Therapy on Shoulder and Neck Pain
Condition: Musculoskeletal Disorders
MeSH terms: Musculoskeletal Diseases; Neck Pain
Study type: Interventional

Summary: 
      The purpose of this research was to investigate the clinical effects on the ESWT treatment of
      shoulder and neck pain.
    

Detailed description: 
      Extracorporeal shock wave therapy (ESWT) has been used to treat various musculoskeletal
      disorders. The beneficial effects of the ESWT included pain alleviation and improvement in
      local blood circulation. However, few study exploring the effects of the ESWT for subjects
      with shoulder and neck pain.
    

Intervention name(s): Extracorporeal shock wave therapy (ESWT); cervical flexion
Intervention type(s): Other; Other
Intervention description(s): The Extracorporeal shock wave therapy (ESWT) was applied on upper trapezius and levator scapulae following parameters 1.5 bar, per intervention 2000 impulse, once a week for three weeks for the experimental group; Education have 8 movement home program for flexion, extension, side bending, rotation in neutral position, and rotation in a position of full cervical flexion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Extracorporeal shock wave therapy (ESWT), Neck Pain