bioihbjkbjnl/mcl2 huggingface dataset:
Ultrasound Guided Steroids Injection Versus PRP for Shoulder Pain Relief
Condition: Shoulder Pain
MeSH terms: Shoulder Pain
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Comparison between effects of ultrasound guided platelet rich plasma injection versus
      steroids injection for pain relief in cases of partial rotator cuff tears
    

Detailed description: 
      The effect of injection of platelet rich plasma will be compared with effects of steroids
      injection according to pain relief effects,, Side effects ,, healing ability ,, recurrence in
      both groups.

      30 patient in each group will be included
    

Intervention name(s): Platelet rich plasma; Methylprednisolone
Intervention type(s): Combination Product; Combination Product
Intervention description(s): platelet rich plasma will be obtained from the particepants own blood mixed with activator and bupivacaine; 1ml methyl prednisolone 40mg\ml mixed with normal saline and bupivacaine
Other intervention name(s): PRP group; steroids group
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups will be included
Masking: Single (Participant)
Primary purpose: Treatment
Immunogenicity, Efficacy and Safety of QazCovid-in® COVID-19 Vaccine
Condition: Covid19; SARS-CoV Infection; Vaccine Adverse Reaction
MeSH terms: COVID-19; Severe Acute Respiratory Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Multicenter, randomized, blind, placebo-controlled clinical study of III phases on the
      assessment of preventive efficiency, safety and immunogenicity QazCovid-in®-vaccine against
      COVID-19 in healthy adult volunteers
    

Detailed description: 
      The main objective of the study is to prove the superiority of the QazCovid-in®-vaccine
      inactivated against COVID-19 in comparison with placebo in terms of seroconversion (the
      proportion of persons with a fourfold or higher increase in antibody titers to SARS-CoV-2) on
      the 21st, 42nd day, 90th and 180th days after vaccination.

      To evaluate the immunogenicity of the QazCovid-in® vaccine inactivated against COVID-19
      versus placebo.

      Evaluate vaccine efficacy.

      Evaluate the safety of vaccine versus placebo.
    

Intervention name(s): QazCovid-in®-vaccine against COVID-19; Placebo
Intervention type(s): Biological; Other
Intervention description(s): QazCovid-in® (inactivated) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan; Placebo (sodium chloride buffs, solvent for the preparation of dosage forms for injection 0.9%)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: QazCovid-in®, vaccine, III phase, efficiency, safety, immunogenicity
Imaging Modalities in Detection of Coronary Artery Disease in End-stage Renal Disease Patients
Condition: Coronary Artery Disease; Myocardial Infarction; Stroke; Death
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      This study investigates hypothesizes that the combination of dobutamine stress
      echocardiography with dobutamine stress echocardiography with real time perfusion myocardial
      contrast echocardiography and coronary computed tomography is a better modality for detecting
      coronary artery disease in end-stage renal disease patients than coronary angiography, and in
      predicting patient outcomes. Demonstrating this would lead to increased use of DSE with RTCE
      and coronary CT at kidney transplant centers throughout the nation, leading to improved
      anatomical and functional detection of CAD without the need for further invasive procedures.
    

Detailed description: 
      Primary: To examine the ability of dobutamine stress dobutamine stress echocardiography with
      real time perfusion (DSE with RTCE) and coronary computed tomographic angiography (cCTA) to
      detect anatomically significant coronary artery disease (CAD) as defined by quantitative
      coronary angiography in end-stage renal disease (ESRD) patients Secondary: To identify which
      of these tests is most predictive of patient outcomes.

      This will be a pilot study enrolling 75 participants. This is based off obtaining 80% power
      and a 90% rectangular confidence region for sensitivity and specificity using one-sided
      confidence limits, this corresponds to two 95% univariate confidence intervals (one for
      sensitivity and one for specificity). With 73 patients screened in total there will be 80%
      power to form a 90% rectangular confidence region around 90% sensitivity and 90% specificity,
      excluding sensitivities less than 69% and specificities less than 73%. We believe the
      sensitivities and specificities of both DSE with RTCE and cCTA will be within these
      confidence regions.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults aged 19-65 with diabetes and end stage renal disease undergoing evaluation for
        kidney transplantation.
Effect of Radical Prostatectomy on Involuntary Pelvic Floor Muscle Contraction
Condition: Lower Urinary Tract Symptoms
MeSH terms: Lower Urinary Tract Symptoms
Study type: Observational

Summary: 
      This study evaluate the effect of radical prostatectomy on involuntary pelvic floor muscle
      contraction
    

Detailed description: 
      Radical prostatectomy may cause stress urinary incontinence (SUI). That poses problem in
      terms of quality of life. There are many treatment options available for patients with SUI,
      but the exact mechanism is not known. We compared, in continent and incontinent men
      post-radical prostatectomy, the correlation between the temporal course of pelvic floor
      activation during cough.

      Simultaneously, recordings of electromyographic activity of external anal sphincter (EAS EMG)
      and external intercostal muscle (EIC EMG) during coughing will be made with a pair of
      pre-gelled electrodes. Cough effort cause an involuntary pelvic contraction. Intercostals
      muscles recording was chosen because they are one of the muscular components of cough
      initiation with diaphragm muscle. 24h pad-weighing test is used to quantify urinary
      incontinence. We will measure the latency between the onset of the EIC EMG and the EAS EMG
      (RT3), during a cough effort. We will also measure the duration of the contraction, the
      maximum EAS EMG activity and the area under the curve.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients consulting for urodynamic assessment
      
Keywords: Radical prostatectomy; urinary incontinence; pelvic floor muscle; reaction time
A Study Investigating the Long-term Safety and Efficacy of Deferiprone in Patients With Friedreich's Ataxia
Condition: Friedreich's Ataxia
MeSH terms: Ataxia; Cerebellar Ataxia; Friedreich Ataxia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the long-term safety and tolerability of
      deferiprone in subjects with Friedreich's ataxia (FRDA).

      The secondary objective is to evaluate the long-term efficacy of deferiprone for the
      treatment of FRDA.

      The tertiary objectives are to evaluate the effect of deferiprone on:

        1. cardiac function,

        2. quality of life, and

        3. functional status.
    

Detailed description: 
      This is a multi-centre, open-label, non-randomized, single treatment, safety and efficacy
      study. All subjects who completed the LA29-0207 study are eligible for participation.
      Participants will receive deferiprone oral solution at the same dose (20 or 40 mg/kg/day)
      that they were assigned for LA29-0207. The duration of treatment will be 52 weeks.
    

Intervention name(s): Deferiprone oral solution 100mg/mL; Deferiprone oral solution 100 mg/mL
Intervention type(s): Drug; Drug
Intervention description(s): Deferiprone oral solution (20 mg/kg/day); Deferiprone oral solution(40mg/kg/day)
Other intervention name(s): Ferriprox; Ferriprox
Intervention MeSH terms: Pharmaceutical Solutions; Deferiprone
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Friedreich's ataxia
Effect of Inhibitors of the Proton Pump on Intestinal Transporters
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Dabigatran etexilate is a novel oral anticoagulant. It is indicated in venous thromboembolic
      prevention in orthopedic surgery and has recently shown greater efficiency and tolerance as
      anticoagulants in preventing thromboembolism in atrial fibrillation. However, it increases
      the risk of gastrointestinal bleeding compared to standard treatment (AVK) [3]. In these
      circumstances the risk / benefit of dabigatran could be improved by combining it with gastric
      protectors such as inhibitor drugs proton pump (IPP).

      Investigators want to evaluate the pharmacokinetic and pharmacodynamic effects of
      co-administration of these two IPP (omeprazole, rabeprazole) with dabigatran in healthy
      subjects.
    


Intervention name(s): Dabigatran; Rabeprazole and Dabigatran; Omeprazole and Dabigatran
Intervention type(s): Drug; Drug; Drug
Intervention description(s): dabigatran etexilate 150 mg/day (1 day); rabeprazole 20 mg / day for 5 days, then the 6th day concomitant rabeprazole 20 mg of dabigatran etexilate 150 mg;; omeprazole 20 mg / day for 5 days, then the sixth day concomitant omeprazole 20 mg and 150 mg dabigatran etexilate
Intervention MeSH terms: Omeprazole; Rabeprazole; Dabigatran
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Keywords: volunteers
Long Term Effect of an Education and Training Program for Patients With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      A parallell group study comparing the effect of an education program with an education and
      training program for patients with COPD. 30 participants in each group. Participants
      self-select which group they wanted to be in. Main outcome is SGRQ (a HQoL for patients with
      COPD).
    


Intervention name(s): education and training program
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Patient education
Effects of Contraceptive Ring on Vaginal Microbiota, HIV Shedding and Local Immunity
Condition: Bacterial Vaginosis; HIV
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators propose to explore the hypothesis-supported by limited data-that a
      contraceptive vaginal ring (CVR) that is commonly used in the United States, the NuvaRing,
      will enhance women's genital and reproductive health. The investigators propose that this CVR
      will increase the bacteria that help the vaginal environment protect against infection by HIV
      and other STIs, and that in women who already have HIV, use of the CVR will lower the
      quantity of HIV that is shed in the female genital tract.
    

Detailed description: 
      The investigators objective is to study effects of a contraceptive vaginal ring (CVR)
      containing estrogen and progesterone (NuvaRing) on vaginal bacteria, HIV shedding, and local
      immunity in women. The investigators will build on data that support a favorable effect of
      CVR on vaginal bacteria. Bacterial vaginosis (BV) is found in >50% of women in sub-Saharan
      Africa. BV significantly increases risk of HIV acquisition in, and HIV transmission to male
      partners from, HIV-infected women, genital HIV shedding, and viral set point in infected male
      partners. Pregnancy is also an independent risk for HIV acquisition and transmission.
      Contraception comprises critical biomedical prevention for women with or at risk for HIV.
      Systemic depot progesterone-commonly used throughout Africa-may independently increase risk
      of HIV acquisition and transmission. Hormonal interventions preventing unintended pregnancy
      and promoting a protective vaginal microenvironment could synergistically reduce HIV risk
      especially combined with topical antiretrovirals (ARV). The investigators propose NuvaRing
      use may contribute to reduction in BV, pregnancy prevention, and decreased rates of HIV
      shedding in HIV-infected women. Sustained vaginal delivery of contraceptive and ARV PrEP as
      "multicomponent prevention" is a major focus for scientists but effects on the vaginal
      environment need careful definition before broad implementation.

      Total duration of follow up is no more than 8 months, with 5 months of CVR usage.
    

Intervention name(s): NuvaRing
Intervention type(s): Drug
Intervention description(s): Provide NuvaRing to women seeking contraception
Other intervention name(s): Contraceptive vaginal ring
Intervention MeSH terms: Contraceptive Agents; NuvaRing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV; Contraceptive Vaginal Ring; Bacterial Vaginosis
Japanese Bridging Trial of Org 37462 (Study P05969)(COMPLETED)
Condition: Controlled Ovarian Stimulation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to find the optimal dose of Org 37462 for Japanese females
      undergoing controlled ovarian stimulation for in vitro fertilization intracytoplasmic sperm
      injection (IVF-ICSI).
    


Intervention name(s): Ganirelix; Ganirelix; Ganirelix
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ganirelix 0.125 mg subcutaneous daily (SC OD) for up to 14 days; Ganirelix 0.25 mg subcutaneous daily (SC OD) for up to 14 days; Ganirelix 0.5 mg subcutaneous daily (SC OD) for up to 14 days
Other intervention name(s): Org 37462; SCH 900761; Orgalutran; Ganirelix Acetate; Ganirest; Org 37462; SCH 900761; Orgalutran; Ganirelix Acetate; Ganirest; Org 37462; SCH 900761; Orgalutran; Ganirelix Acetate; Ganirest
Intervention MeSH terms: Ganirelix
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Effect Of Multifidus And Transversus Abdominis Muscle Activation On Balance In Hemiplegic Patients
Condition: Hemiplegia
MeSH terms: Hemiplegia
Study type: Observational

Summary: 
      Patients with post-stroke hemiplegia may develop balance disorder and limitation in
      ambulation ability due to multiple mechanisms.

      The effects of core muscles on maintaining normal posture, balance and ambulation ability are
      known. The positive effects of core stabilisation exercises on balance in hemiplegic patients
      have been shown in previous studies. In this study, we planned to investigate the effects of
      bilateral transversus abdominis and bilateral lumbar multifidus muscles on balance in
      patients with stroke-related hemiplegia.
    

Detailed description: 
      Loss of function in the trunk muscles of stroke patients leads to both balance problems and
      excessive effort to maintain balance. While ambulation ability of some patients is completely
      lost due to stroke, in others, impaired balance and increased postural oscillation lead to
      fear of falling and increased risk of falling.

      In previous studies, it has been shown that there is a significant relationship between
      static balance and duration of hospital stay and functional abilities after stroke. In
      another study, it was shown that the control ability of the trunk muscles in the early
      post-stroke period was a strong factor affecting general life activities in the first six
      months after stroke.

      Trunk muscles are innervated by both hemispheres unlike the extremities. Therefore,
      unilateral stroke may impair the function of trunk muscles on both the contralateral and
      ipsilateral sides. Several studies have shown dysfunction of bilateral trunk flexor, extensor
      and rotator muscles in patients with unilateral stroke.

      Many studies have proven that core stabilisation exercises are effective on both balance and
      gait function and general life activities in hemiplegic patients.

      The aim of this cross-sectional study was to investigate the effect of ultrasound-guided
      bilateral transversus abdominis and bilateral lumbar multifidus muscle activations on balance
      in hemiplegic patients.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        36 hemiplegic patients who met the inclusion criteria and did not meet the exclusion
        criteria
      
Keywords: hemiplegia; transversus abdominis; multifidus; balance; stroke
An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Hormonal Imbalance
Condition: Hormone Disturbance
MeSH terms: Endocrine System Diseases
Study type: Interventional

Summary: 
      This is an open-label observational trial to study the effectiveness of a commercial dietary
      supplement and its effect on common symptoms of normal menstrual discomfort.
    

Detailed description: 
      This is an open-label observational trial to study the effectiveness of a commercial dietary
      supplement and its effect on common symptoms of normal menstrual discomfort.

      It is hypothesized that the dietary supplement marketed as The Daily will improve subjective
      wellbeing in trial participants. It is further hypothesized that the dietary supplement will
      improve plasma biomarkers that have been previously correlated with insulin resistance.

      A total of 45 participants will be recruited for the trial following screening, with the
      expectation that at least 35 will complete the trial. The trial will be fully remote, and all
      participants will undergo a menstrual cycle without intervention to establish a baseline, and
      then will be given the intervention (dietary supplement) for a second menstrual cycle.
    

Intervention name(s): Semaine Hormonal Imbalance & The Daily
Intervention type(s): Dietary Supplement
Intervention description(s): All participants will undergo a menstrual cycle without intervention to establish a baseline, and then will be given the intervention (dietary supplement) for a second menstrual cycle.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Black Raspberry Nectar for the Prevention of Lung Cancer, BE WELL Study
Condition: Lung Carcinoma; Tobacco-Related Carcinoma
MeSH terms: Carcinoma
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This trial studies how well black raspberry nectar works in changing the gut microbiome and
      in reducing inflammatory processes that may lead to lung cancer. Studying the effects of
      black raspberry beverage on inflammation may help doctors find strategies to reduce the risk
      of developing lung cancer.
    

Detailed description: 
      PRIMARY FEASIBILITY OBJECTIVE:

      I. To evaluate the feasibility of establishing a diet intervention trial with longitudinal
      microbiome collection in Ohio State University Comprehensive Cancer Center (OSUCCC) Lung
      Cancer Screening Clinic (OSUCCC-LCSC).

      PRIMARY SCIENTIFIC OBJECTIVE:

      I. To determine the impact of the black raspberry (BRB) nectar intervention on the microbiome
      and inflammatory biomarkers.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM I: Patients receive BRB nectar orally (PO) twice daily (BID) for weeks 0-4 and then
      receive placebo PO BID for weeks 6-10 in the absence of unacceptable toxicity. Patients also
      undergo collection of nasal swabs, blood, urine, and stool samples at weeks 0, 4, 6, and 10.

      ARM II: Patients receive placebo PO BID for weeks 0-4 and then receive BRB nectar PO BID for
      weeks 6-10 in the absence of unacceptable toxicity. Patients also undergo collection of nasal
      swabs, blood, urine, and stool samples at weeks 0, 4, 6, and 10.
    

Intervention name(s): Biospecimen Collection; Nutritional Supplementation; Placebo Administration; Questionnaire Administration
Intervention type(s): Procedure; Dietary Supplement; Drug; Other
Intervention description(s): Undergo collection of nasal swabs, blood, urine, and stool; Given black raspberry nectar PO; Given PO; Ancillary studies
Other intervention name(s): supplementation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Platelet Rich Fibrin+1.2% Atorvastatin in Treatment of Mandibular Degree II Furcation Defects
Condition: Furcation Defects
MeSH terms: Furcation Defects
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The present study was designed to explore the effectiveness of PRF combined with 1.2% ATV gel
      in treatment of mandibular degree II furcation defects in comparison to PRF and open flap
      debridement (OFD) alone.
    

Detailed description: 
      Background: A variety of regenerative materials have been tried since many years for the
      treatment of furcation defects. Platelet-rich fibrin (PRF), a pool reservoir of platelet
      concentrate with growth factors and Atorvastatin (ATV), a potent member of statin group are
      known to promote periodontal tissue regeneration. The aim of the present study is to explore
      the effectiveness of PRF combined with 1.2% ATV gel in treatment of mandibular degree II
      furcation defects in comparison to PRF and open flap debridement (OFD) alone.

      Methods: Eighty two mandibular furcation defects were treated with either OFD alone (Group
      1), OFD with PRF (Group 2), and OFD with PRF+1.2% ATV gel (Group 3).Clinical parameters like
      probing depth (PD), relative vertical clinical attachment level (RVCAL), relative horizontal
      clinical attachment level (RHCAL), modified sulcus bleeding index (mSBI) and site specific
      plaque index (PI) were recorded at baseline and 9 months post-operatively. The radiological
      assessment of bone defect fill was done at baseline and 9 months, using computer-aided
      software.
    

Intervention name(s): Open flap debridement (OFD); OFD with Platelet rich fibrin (PRF); OFD with Platelet rich fibrin (PRF)+1.2% Atorvastatin (Drug) in gel form
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Open flap debridement (OFD) alone; Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement; Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1.2% Atorvastatin gel placement
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment