bioihbjkbjnl/mcl2 huggingface dataset:
Radiofrequency Microtenotomy for Treatment of Rotator Cuff Tendinopathy
Condition: Shoulder Impingement Syndrome
MeSH terms: Tendinopathy; Shoulder Impingement Syndrome
Study type: Interventional

Summary: 
      This study compare the outcome (pain, function) after Radiofrequency microtenotomy (group I)
      and acromioplasty (group II) for treatment of rotator cuff tendinosis in the shoulder.

      The outcome of both methods will be compared to the physical therapy treatment (groupIII)
    

Detailed description: 
      Rotator cuff tendinosis cause pain and disability of the shoulder. Tendinosis, sometimes
      complicated by partial rupture, appears to be the major lesion in chronic rotator cuff
      tendinopathy. Important features is a poor intrinsic ability to heal.

      Several patients receive treatment for shoulder tendinosis each year. Conservative treatments
      options include rest, stretching, strengthening, ice and/or physical therapy are used with
      difference results. A traditional surgical treatments (acromioplasty) have been reported with
      variable results..

      The aim of this study is to evaluate improvement of VAS and functionality using Constant
      score before and after treatment of rotator cuff tendinosis using radiofrequency-plasma based
      microtenotomy in comparison to traditional acromioplasty and physical therapy.
    

Intervention name(s): Arthroscopic acromioplasty; Microtenotomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Surgical intervention With arthroscopic acromion resection; Arthroscopic radiofrequency microtenotomy of rotator cuff tendon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rotator cuff; Tendinosis; Impingement; radiofrequency
Let's be Well Red: Efficacy of Gudness Bars in Improving the Hemoglobin and Hematocrit Levels of Anemic Subjects
Condition: Treatment and Prevention of Anemia After Administration of Gudness Nutrition Bar
MeSH terms: Anemia
Study type: Interventional

Summary: 
      To test the efficacy of Gudness Bars in improving the hemoglobin and hematocrit levels of
      anemic subjects longitudinally.

      To quantify the demographics of subjects attending anemia testing camps through LBWR and to
      explore correlations with the demographics data.
    


Intervention name(s): Education plus Gudness Nutritional Bar; Education
Intervention type(s): Dietary Supplement; Other
Other intervention name(s): Education about Anemia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: anemia
Serbian Smoking Reduction/Cessation Trial (2SRT)
Condition: Cigarette Smoking
Study type: Interventional
Phase: Phase 4

Summary: 
      The study aims to establish if a low-nitrosamine, smokeless tobacco product (Swedish snus)
      can help adult smokers to reduce and eventually completely quit smoking.
    


Intervention name(s): Swedish snus (smokeless tobacco); Onico
Intervention type(s): Other; Other
Intervention description(s): Snus in sachets 1.0 g or 0.5 g, 2 flavors. Usage ad libitum.; Tobacco-free, nicotine-free placebo snus, 2 sachet sizes (1.0 g, 0.5 g), 2 flavors (same as in the experimental arm). Usage ad libitum.
Other intervention name(s): Onico (brand name)
Intervention MeSH terms: Lobeline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: smoking reduction; smoking cessation; randomized trial; Swedish snus; smokeless tobacco
Probiotic Detection and Persistence Study
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aims of this study are to determine how long it takes for the strains of a probiotic
      formulation to be detected in feces after the start of an intervention, how long they persist
      after the end of the intervention, and the associations between detection and persistence
      with total gut transit time.
    

Detailed description: 
      This is a 10-week interventional, open-label pilot study designed to evaluate the detection
      and persistence of L. helveticus R-0052, L. casei NI319, B. breve NI337, and B. longum R-0175
      strains in feces of healthy adults following the start and the end of IP intervention,
      respectively. This study will have an initial baseline period (4 weeks), a probiotic
      intervention (2 weeks) and a washout period (4 weeks). Participants will complete daily
      questionnaires regarding stool frequency, time of stool collections, and IP intake. A weekly
      Gastrointestinal Symptom Rating Scale (GSRS) questionnaire will be administered. Transit time
      will be assessed using radiopaque markers.
    

Intervention name(s): Probiotic Strains
Intervention type(s): Biological
Intervention description(s): A commercial product containing L. helveticus R0052, L. casei HA-108, B. breve HA-129, and B. longum R0175 and S. thermophilus HA-110 be given to healthy adults across a 10-week open label pilot study.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: probiotic; gut transit time
Influence of Moxifloxacin on QTc Interval in Healthy Subjects for Positive Control Validation
Condition: QTc Evaluation; Electrocardiography
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to investigate the effect of moxifloxacin on the QT interval in
      order to gain information on the validity of results that will be collected during another
      clinical study testing riociguat in patients with pulmonary arterial hypertension (PATENT-1
      study).
    


Intervention name(s): Avelox (Moxifloxacin, BAY12-8039); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 400 mg; Single dose of matching tablet
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Moxifloxacin
Amitriptyline vs GON and SON Blocks in Migraine
Condition: Migraine; Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

Summary: 
      Comparison of efficacy and safety of amitriptyline and nerve blocks
    

Detailed description: 
      This study aims to compare the efficacy and safety of amitriptyline and nerve blocks (greater
      occipital nerve and supraorbital nerve)
    

Intervention name(s): Lidocaine 1% Injectable Solution; Amitriptyline
Intervention type(s): Drug; Drug
Intervention description(s): Repeated injections of lidocaine to greater occipital nerve and supraorbital nerve once a week for first four weeks then once a month for five months; Amitriptyline 25 mg daily
Intervention MeSH terms: Lidocaine; Amitriptyline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: greater occipital nerve; supraorbital nerve; nerve blocks
Day 3 Fresh Transfer Followed by Day 3 or Day 5 Vitrification of Supernumerary Embryos
Condition: Subfertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      This monocenter academic study aims to evaluate the effectiveness and cost effectiveness of
      two different strategies: fresh Embryo Transfer (ET) on day 3 followed by cryopreservation of
      cleavage-stage (Day 3) embryos versus blastocyst-stage (Day 5) embryos.

      The primary outcome is the cumulative pregnancy rate after all transfers (fresh and/or frozen
      embryo transfer cycles which might take about 1 year), up to two sequential cycles. The
      secondary outcome concerns a cost analysis of both strategies from the healthcare payer's
      perspective.
    


Intervention name(s): Day of vitrification
Intervention type(s): Procedure
Intervention description(s): Supernumerary embryos after fresh transfer on Day 3 after oocyte aspiration are either vitrified on Day 3 or are kept in culture until Day 5 and vitrified on Day 5
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Balance Trainning for Sarcopenic Inpatients Aged 80+ Years
Condition: Sarcopenia
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      Resistance training and aerobic exercise have been recommended for sarcopenic patients.
      However, whether balance training would further benefit for sarcopenic patients on the basis
      of resistance training and aerobic exercise remains unclear. The purpose of this study is to
      explore the effect of balance training on improving the mobility of elderly patients with
      sarcopenia. Balance training involves doing exercises that strengthen the muscles that help
      keep the aged upright, including the legs and core. These kinds of exercises can improve
      stability and help prevent falls.
    


Intervention name(s): balance training; resistance training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The training to improve balance is to work on the core muscle groups that help to maintain your posture.,and increase muscular strength.; Resistance training is a form of exercise that improves muscular strength and endurance. During a resistance training workout, you move your limbs against resistance provided by your body weight, gravity, bands, weighted bars or dumbbells.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Ultrasound Guided Thoracic Paravertebral Block for Percutaneous Nephrolithotomy Operations in Children
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators aimed to evaluate the effect of ultrasound guided thoracic paravertebral
      block with bupivacaine on both perioperative anesthetic agent consumption and postoperative
      analgesia in pediatric patients undergoing percutaneous nephrolithotomy for kidney stone.
    

Detailed description: 
      This study was performed after approval of Ethics Committee and parents written consent.
      Between the ages 1-5, planned percutaneous nephrolithotomy due to kidney stones 40 patients
      were enrolled in this study, and patients were randomly divided into two group. All patients
      were performed general anaesthesia. The Group I patients was given ultrasound guided thoracic
      paravertebral block with 0.5 ml/kg bupivacaine %0.5 after giving prone position and the Group
      II patients was given 15 mg/kg of paracetamol as postoperative analgesia. In the period of
      postoperative, if the FLACC > 4; it was planned to dose 1 mg/kg of tramadol. Patients'
      hemodynamic parameters, oxygen saturation, sevoflurane concentration were recorded 10, 15, 30
      and 60 minutes intraoperatively. Patients' hemodynamic parameters, oxygen saturation, pain
      scores (FLACC), satisfaction of parents, the number of patients who additional analgesic
      requirements and side effects (nausea,vomiting, hypotension, bradycardia, respiration
      problems etc) were recorded in the postoperative period. Primary outcome measures was pain
      scores using FLACC scale.
    

Intervention name(s): paravertebral blockade
Intervention type(s): Procedure
Intervention description(s): ultrasound guided thoracic paravertebral block with 0.5 ml/kg bupivacaine %0.5
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
The Effect of Cinnamon on HbA1c Among Adolescents With Type I Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      the purpose of this study is to determine if cinnamon improves glucose control among
      adolescents with type 1 diabetes mellitus.
    

Detailed description: 
      Widespread achievement of glucose control remains an elusive goal for adolescents with Type 1
      diabetes. Previous research has suggested that cinnamon may be effective at improving glucose
      control in type 2 diabetes. To date, no research has investigated the effect of cinnamon on
      type 1 diabetics. If the addition of a simple, natural, pill to a standard insulin regimen
      can significantly improve glucose control, the clinical implications would be substantial.

      Comparison: Using a prospective, double-blind, placebo-controlled design, 72 adolescent type
      I diabetics were treated with cinnamon (1 gram/day) or an equivalent appearing placebo for 90
      days. HbA1c, total daily insulin intake, and adverse events were recorded and compared
      between groups.
    

Intervention name(s): cinnamon
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Cinnamon; Type 1 Diabetes; Adolescent; HbA1c
SELF - BREATHE for Chronic Breathlessness
Condition: COPD; Cancer; Heart Failure; Interstitial Disease; Dyspnea
MeSH terms: Dyspnea
Study type: Observational

Summary: 
      Semi-structured qualitative interviews will be conducted to understand key factors that would
      enable / facilitate patients with chronic breathlessness to potentially use an online
      breathlessness intervention (SELF-BREATHE).
    

Detailed description: 
      STUDY OVERVIEW

      Full title:

      A self -guided, internet -based intervention for patients with chronic breathlessness
      (SELF-BREATHE): an interview study.

      Objective:

      To understand the key factors that would enable / facilitate patients with chronic
      breathlessness to use an online breathlessness support intervention (SELF-BREATHE).

      Study type:

      Qualitative interview study

      Methods:

      Semi-structured qualitative interviews will be conducted to achieve maximum variation in
      approx 20 patients with chronic breathlessness (a purposive sample: age sex, diagnoses, and
      presence of caregiver).

      The interview will explore and identify:

      Patients' views/experiences of internet-based activities, e.g. digital apps, shopping online;
      Patients' understanding, preferences, values and motivations that would influence uptake of
      SELF-BREATHE; Potential barriers to the development and use of SELF-BREATHE; Facilitators to
      usage of SELF-BREATHE, such as the ability to self-monitor progress etc...

      These topics cover areas of uncertainty in order to optimise the SELF - BREATHE intervention.

      Inclusion criteria:

      Adult patients >18 years of age, with the ability to read, converse in English and able to
      provide informed consent

      Chronic breathlessness on exertion and or rest (MRC dysponea score >2)

      Advanced disease such as cancer, chronic obstructive pulmonary disease (COPD), chronic heart
      failure (CHF) or interstitial lung disease (ILD), where the underlying disease is deemed to
      be optimally medically managed by the referring clinician / allied health professional /
      clinical nurse specialist

      Exclusion criteria:

      Breathlessness of unknown cause

      A primary diagnosis of chronic hyperventilation syndrome
    

Intervention name(s): Qualitative research interviews to be conducted
Intervention type(s): Other
Intervention description(s): None. Qualitative research interviews to be conducted
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        COPD, Cancer, Heart Failure, Interstitial Lung disease, Dyspnea
Use of GM-CSF Supplemented IVF Medium in Patients With Recurrent Implantation Failure
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether in Assisted Reproductive Technologies the
      use of culture medium supplemented with GM-CSF, a growth factor working on stem cells, may
      improve the embryo implantation in patients experiencing recurrent implantation failure in
      IVF cycles.
    

Detailed description: 
      In Assisted Reproductive Technologies the rate of pregnancy for cycle and the implantation
      rate remain low nevertheless the improvement in the last years. In particular there are a
      group of patients, in young reproductive age, experiencing recurrent implantation failure,
      nevertheless the good embryos produced and transferred. Recently, it has been showed that
      culture medium supplemented with GM-CSF, may improve the embryo outcomes in IVF. In this
      trial the investigators will test the potential benefits of this culture medium on embryos of
      patients experiencing recurrent implantation failure. 100 women with recurrent implantation
      failure, at least three failed previous IVF attempts with at least 8 good embryos transferred
      no more than 40 years old will be selected. These patients will be assigned to two arms, one
      experimental and one other of control by a computer generated sequence. After the oocyte
      retrieval and fertilization by ICSI procedure, the fertilised oocyte (2PN)will cultured with
      the GM-CSF supplemented culture medium (EmbryoGen, Origio, Denmark), or in normal culture in
      micro drop of 30microliters under oil until the day of transfer (day three or 8 cells sage
      embryos). A maximum of three embryos will be transferred. The pregnancy rate the implantation
      rate will be the outcomes considered
    

Intervention name(s): GM-CSF medium; CONTROL
Intervention type(s): Drug; Drug
Intervention description(s): incubation of IVF embryos with a specific medium containing GM-CSF; group of controls treated with a standard IVF medium
Other intervention name(s): Embryogen; NORMAL MEDIUM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: GM-CSF; recurrent implantation failure; pregnancy rate; IVF
TDCS Combined With CT In Opioid Use Disorder
Condition: Opioid Use Disorder
MeSH terms: Opioid-Related Disorders; Substance-Related Disorders
Study type: Interventional

Summary: 
      The aim of the present study is to investigate the effect of prefrontal transcranial Direct
      Current Stimulation (tDCS) combined with cognitive training on cognitive functions in
      individuals with Opioid Use Disorder (OUD). The participants will be allocated into
      active/sham groups (1:1) and will receive a single session of prefrontal tDCS combined with
      cognitive training. Outcomes of the active and sham groups will be compared.
    


Intervention name(s): transcranial Direct Current Stimulation; Cognitive training
Intervention type(s): Device; Procedure
Intervention description(s): Participants will receive a single session of active/sham tDCS. During each session, 2 milliAmpers of active or sham tDCS will be applied for 20 minutes over the dorsolateral prefrontal cortex (right anodal/left cathodal).; Participants will be administered Game of Dice Task concurrent with the tDCS session
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: brain stimulation; cognitive functions; neuropsychological evaluation; opioid use disorder; transcranial direct current stimulation
Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Germany (LIFE-C)
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Observational

Summary: 
      The interferon-free combination regimen of paritaprevir/r - ombitasvir with or without
      dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC)
      has been shown to be safe and effective in randomized controlled clinical trials with strict
      inclusion and exclusion criteria under well controlled conditions.

      This observational study is the first effectiveness research examining the ABBVIE REGIMEN ±
      RBV, used according to local label, under real world conditions in Germany in a clinical
      practice patient population.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Chronic Hepatitis C (CHC)
      
Keywords: Chronic Hepatitis C; Dasabuvir; Ombitasvir+Paritaprevir+Ritonavir; Observational Study; Quality of life; Work-ability; Fibrosis; Cirrhosis
P1 Single and Multiple Ascending Dose (SAD/MAD) Study of IV QPX7728 Alone and Combined With QPX2014 in NHV
Condition: Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      QPX7728 is an ultra-broad-spectrum beta-lactamase inhibitor, with activity against numerous
      beta-lactamases, including class A extended spectrum beta-lactamases (ESBLs), class C
      cephalosporinases, and extended spectrum class D oxacillinases (OXA) that can hydrolyze
      cephalosporins and can be found in Enterobacteriaceae and Pseudomonas aeruginosa (P.
      aeruginosa). QPX7728 is also a potent inhibitor of carbapenemases from all molecular classes,
      such as class A Klebsiella pheumoniae carbapenemase (KPC), class B New-Dehli
      Metalo-beta-lactamase (NDM) and Verona integron-encoded metallo-beta-lactamase (VIM), and
      class D OXA-48 that are found in carbapenem resistant Enterobacteriaceae, and also class D
      carbapenemases such as OXA-23 that are found in carbapenem resistant Acinetobacter baumannii.
    

Detailed description: 
      The Centers for Disease Control (CDC) has listed carbapenem-resistant Enterobacteriaceae and
      Acinetobacter as urgent threats and multidrug resistant Pseudomonas, and extended spectrum
      beta-lactamase (ESBL)-producing Enterobacteriaceae as serious threats [CDC, 2019]. Consistent
      with the global nature of these resistant bacteria, the World Health Organization (WHO) has
      designated carbapenem-resistant, ESBL-producing Enterobacteriaceae, carbapenem-resistant
      Acinetobacter baumannii, and carbapenem-resistant Pseudomonas aeruginosa as pathogens for
      which new agents are critically needed [WHO, 2017].

      Qpex Biopharma is developing a fixed combination antibiotic of QPX2014 plus an ultra-broad
      spectrum beta-lactamase inhibitor, QPX7728.
    

Intervention name(s): QPX7728; Placebo; QPX2014
Intervention type(s): Drug; Drug; Drug
Intervention description(s): antibiotic; Placebo comparator; antibiotic
Other intervention name(s): IV; IV saline; IV
Intervention MeSH terms: QPX7728
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double-blind, placebo controlled ascending single, multiple and combination dose
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: beta-lactam antibiotic