bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Bacterial Vaginosis (BV) With Tinidazole
Condition: Bacterial Vaginosis
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      We are trying to determine if treatment of bacterial vaginosis with tinidazole is better than
      treatment with metronidazole
    

Detailed description: 
      Bacterial vaginosis (BV) is the most prevalent cause of symptomatic vaginal discharge in the
      U.S. and has been associated with complications including preterm delivery of infants, pelvic
      inflammatory disease (PID), urinary tract infections (UTI) and acquisition/transmission of
      sexually transmitted diseases (STDs) including human immunodeficiency virus (HIV). Control of
      BV has been advocated as a means of decreasing the prevalence of these complications.
      However, the etiology of BV remains unknown and the current treatment regimens are inadequate
      in terms of initial cure and recurrence rates. Although not currently licensed in the U.S.,
      tinidazole is an antimicrobial related to metronidazole which has shown promise for the
      treatment of BV in European studies and is widely used worldwide for the treatment of
      trichomoniasis including infections which are resistant to metronidazole. We hypothesize that
      qualities of tinidazole such as its longer half-life and its seemingly superior side effect
      profile as compared to oral metronidazole will result in its being a more efficacious drug
      for the treatment of BV than the currently available options.

      The specific aims of this project are:

        1. To compare the efficacy of two different doses of tinidazole with oral metronidazole for
           the initial treatment of symptomatic BV as well as short-term recurrence rates

        2. To compare the side effect profiles of tinidazole versus metronidazole in the treatment
           of BV

        3. To compare drug levels of tinidazole and metronidazole in the vaginal secretions and
           correlate with microbiologic cure of BV as well as rates of recurrence.
    

Intervention name(s): tinidazole, metronidazole
Intervention type(s): Drug
Intervention description(s): Tinidazole 500 mg bid; Tinidazole 1mg bid; Metronidazole 500mg bid
Other intervention name(s): Tindamax, Flagyl
Intervention MeSH terms: Metronidazole; Tinidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: bacterial vaginosis; tinidazole
Telerehabilitation Based on Aerobic Exercise in Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Fibromyalgia syndrome is the most common cause of chronic generalized musculoskeletal pain
      and is characterized by pain associated with generalizad sensitivity, fatigue, sleep
      disturbances and psychological problems. Due to the chronic nature of the pathology and the
      great dependence on analgesic drugs that it often entails, in these patients it is considered
      necessary to provide an individualized approach and provide strategies that allow symptoms to
      be controlled conservatively and non-pharmacologically.

      The objective of this trial is to analyse the immediate effects on pain, mechanical pain
      sensitivity, impact of fibromyalgia, pain catastrophizing, psychological distress and
      physical function when a telerehabilitation program based on aerobic exercise is applied in
      women with fibromyalgia.

      For this purpose the investigators conduct a randomized controlled trial single-blind
      (examiner). The investigators included female patients diagnosed of fibromyalgia according to
      the American College of Rheumatology (ACR).

      Thirty-four women with fibromyalgia are included and randomized into 2 groups:
      telerehabilitation program group based on aerobic exercise and control group. Exercise group
      receive 2 treatment sessions a week over 15 weeks.

      All the variables are measured at the beginning of intervention and after the intervention.
    


Intervention name(s): Telerehabilitation based on aerobic exercise
Intervention type(s): Other
Intervention description(s): To perform different whole body aerobic exercises moderately intense according to Borg scale.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: exercise; aerobic exercise; telerehabilitation
Time to Conceive: A Study of Fertility
Condition: Healthy
Study type: Observational

Summary: 
      The purpose of this research study is to learn a way to measure a person's fertility. After 1
      year of trying, 1 out of every 7 women will not be pregnant. This is called infertility. This
      results in significant distress and anxiety. Infertility is common; however, the
      investigators have no markers to predict who will be infertile. For couples diagnosed with
      infertility, the investigators have used blood and urine hormone levels (follicle stimulating
      hormone (FSH), inhibin B, and antimullerian hormone (AMH)) to tell us who will get pregnant
      with fertility treatment. The investigators don't know if these hormone levels can predict if
      regular people trying to get pregnant will be able to get pregnant. This study will try to
      determine if these hormone levels can predict fertility and infertility.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): Study participants will not be asked to make any changes to their daily lifestyle or existing health care routine. Participants also will not be asked to take any medications or change their diet.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy women living in Chapel Hill, Raleigh, Durham, and the surrounding communities of
        the Triangle Area in North Carolina.
      
Biospecimen description: 
      Serum, Urine
    
Keywords: Fertility; Trying to Conceive; Trying to Get Pregnant; Pregnancy
Evaluation of the Digestive and Metabolic Utilisation of Dietary Protein in Patients With Chronic Pancreatitis
Condition: Chronic Pancreatitis
MeSH terms: Pancreatitis; Pancreatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective is to evaluate the dietary nitrogen assimilation and metabolic utilisation
      capability of patients with chronic pancreatitis.
    


Intervention name(s): Creon
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic pancreatitis; exocrine pancreatic insufficiency; enzyme therapy; patients with chronic pancreatitis and exocrine pancreatic insufficiency; taking enzyme replacement therapy
Psychodynamic Motivation and Training Program
Condition: Coronary Heart Disease; Physical Activity
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effectiveness of a Psychodynamic Motivation and
      Training Program (PMT) for the improvement of physical fitness in patients with stable
      coronary heart disease as compared to advice in exercise training or treatment as usual.
    

Detailed description: 
      Nonpharmacological secondary prevention of coronary heart disease is considered to be a safe
      and effective measure for reducing mortality substantially. Major targets are the improvement
      of physical activity and dietary habits, smoking cessation and stress reduction. Despite the
      effectiveness of life style changes, the compliance rate of patients is very low. To improve
      compliance with life style change programs psychotherapeutic interventions appear to have
      significant potential. Against this background our study aims to examine the effectiveness of
      a Psychodynamic Motivation and Training Program (PMT) in addition to one session of advice in
      exercise training based on the results of spiroergometry (+EX) and usual cardiological care
      (TAU). PMT will be compared with +Ex and TAU. N = 90 patients with stable coronary artery
      disease class, low physical activity, class I to III angina pectoris will be randomly
      assigned to the three treatment conditions. The Primary efficacy endpoint is change in the
      anaerobic threshold from baseline to 6 month follow-up. The results of the study will 1) help
      to determine the effectiveness of a psychodynamic life style change programs for the
      secondary prevention of cardiovascular disease and 2) will help to identify measures for
      designing specifically tailored interventions to improve compliance with cardiovascular
      prevention.
    

Intervention name(s): Psychodynamic Motivation and Training Program (PMT); Advice in Exercise Training (+Ex); Treatment as usual (TAU)
Intervention type(s): Behavioral; Behavioral; Other
Intervention description(s): The Psychodynamic Motivation and Training Program (PMT) is a psychodynamic stepped care approach. Depending on the individual needs PMT consists of 3 to 8 sessions of individual psychodynamic psychotherapy. If appropriate session 4 - 8 may be conducted by a nurse. PMT targets the mental and external barriers to improve physical activity by focusing on affects, interpersonal relations and maladaptive self- and other representations. PMT will be offered in addition to +Ex.; Advice in Exercise Training consists of one individual session of advice in exercise training based on the results of the spiroergometry.; Usual care by family doctor, cardiologist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: psychodynamic psychotherapy; coronary heart disease; physical activity; secondary prevention
A Study to Evaluate the Effect of Oral Mirabegron on the Heart in Healthy Males and Females
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to evaluate the effect of repeat oral dosing of mirabegron on
      ECG (electrocardiogram) measurements.
    

Detailed description: 
      Each subject will be randomized and participate in two 10-day treatment periods during which
      once daily dosing of mirabegron and mirabegron/moxifloxacin placebo or moxifloxacin and
      moxifloxacin/mirabegron placebo will occur followed by a 1-day post-treatment period. Each
      treatment period will be separated by a washout period of at least 12 days from the last dose
      of study drug on Day 10 of Period 1 to Day -4 of Period 2.
    

Intervention name(s): Placebo; mirabegron; moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral; oral; oral
Other intervention name(s): YM178; Avelox
Intervention MeSH terms: Moxifloxacin; Mirabegron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: YM178; Mirabegron; QT
Safety and Activity of F14 for Management of Pain Following Total Knee Replacement
Condition: Total Knee Replacement; Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      The safety and activity of a single, 3.5 mL dose of F14 (celecoxib) concurrent with standard
      of care analgesia administered following total knee replacement will be compared to standard
      of care analgesia alone.
    

Detailed description: 
      This is a randomized, single-blind, active control study in participants undergoing primary
      unilateral total knee replacement (TKR). Fifty (50) participants will be randomized 1:1 to
      receive either a single, 3.5 mL dose of F14 (celecoxib) concurrent with standard of care
      analgesia, or only standard of care analgesia. F14 will be administered into the joint space
      at the end of surgery and just prior to wound closing. Safety will be evaluated through
      recording of adverse events, vital signs, ECG, physical and knee-specific examinations,
      laboratory blood tests and standing x-rays of the TKR obtained at 3 and 12 months.
      Post-operative pain will be assessed using visual analog scores (VAS) and Western Ontario and
      McMaster Universities Osteoarthritis Index (WOMAC) questionnaires and the Timed Up and Go
      test. Concomitant medication usage including MSO4 equivalents will be monitored daily for 3
      months with participant drug diaries, and at the 12-month visit. Perceived benefit of
      analgesia will be compared using the Overall Benefit of Analgesic Score (OBAS). The
      pharmacokinetic profile of celecoxib in plasma will be assessed up to 3 months. Standardized
      physical therapy will be implemented post-operatively. Follow-up study visits will occur at
      1, 2, 3, 4 (phone) and 6 weeks, 3 and 12 months.
    

Intervention name(s): Bupivacaine HCl; F14 (celecoxib)
Intervention type(s): Drug; Drug
Intervention description(s): 0.25% Bupivacaine HCl; Celecoxib in novel drug delivery system (BEPO™)
Other intervention name(s): Marcaine
Intervention MeSH terms: Celecoxib; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: total knee replacement; pain; celecoxib; intra-articular
Evaluation of GIMate Handheld Hydrogen Breath Monitor for Diagnosis of Lactose Malabsorption
Condition: Lactose Intolerance
MeSH terms: Malabsorption Syndromes; Lactose Intolerance
Study type: Interventional

Summary: 
      The goal of this study is to assess the performance of the Vivante Health GIMate Breathalyzer
      device in diagnosing lactose malabsorption.
    

Detailed description: 
      Lactose malabsorption is a common condition due to lactase deficiency which results in
      gastrointestinal symptoms for many which is termed lactose intolerance. Lactase is an enzyme
      occurring in the intestinal mucosa that hydrolyzes lactose into its constituent parts,
      galactose and glucose. The enzyme is normally present in neonates, however, for a majority of
      individuals in the world there is an inherited and irreversible reduction in enzyme activity
      as individuals age. Secondary lactose malabsorption can also occur when there is injury to
      the intestinal mucosa from a reversible condition such as infection.

      The mechanism of hydrogen detection is based on undigested lactose in the colon being
      fermented by bacteria resulting in the production of hydrogen which is then partially
      absorbed into the bloodstream and ultimately exhaled by the lungs via the pulmonary
      circulation and gas exchange. Direct lactase activity can also be measured on tissue obtained
      through jejunal biopsy via endoscopy. This approach, however, is more invasive, costly, and
      potentially less reliable given issues relating to sampling bias

      Current clinical hydrogen breath tests for diagnosis of lactose malabsorption are bulky and
      expensive for clinical providers to use and obtain. As a result, Vivante Health is testing
      how effective the GIMate device is in diagnosing lactose malabsorption as an alternative
      option.
    

Intervention name(s): GIMate; H2 Check
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Use of GIMate to detect lactose malabsorption; Use of H2 Check to detect lactose malabsorption
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Structural Changes of Subcutaneous Tissue by Ultrasonographies in Patients After Treatment With PnKCelulitis® Program
Condition: Cellulite
MeSH terms: Cellulite
Study type: Observational [Patient Registry]

Summary: 
      Exploratory, prospective, uncontrolled and single-blinded pilot study, with clinical and
      ultrasound assessments of cutaneous cellulite before and after treatment with a specific
      multidisciplinary programme following dietary guidelines, physical exercise and the
      application of a cosmetic cream.
    

Detailed description: 
      Females older than 18, with normal weight ranges in addition to the presence of cutaneous
      non-infectious cellulite (edematous-fibrosclerotic panniculopathy), were recruited for the
      study and to undergo treatment with the multidisciplinary programme.

      All patients were treated with the specific multidisciplinary programme for cellulite
      (PnKCelulitis®). This programme consists of three phases or processes: the restructuring,
      drainage and toning processes, each of which combines diet, physical exercise and the
      application of an anti-cellulite cream that combines active lipolytic and vasodilator agents
      (Cellulite Gel K-Line®).

      Patient's clinical assessment follow-up was performed by the prescribing doctor for the
      multidisciplinary treatment and was done in four visits: baseline (before starting treatment)
      and at the end of each of the phases (restructuring, drainage and toning). Anthropometric
      data were recorded at each visit and a bioelectric impedance test to assess body composition
      (amount of fat mass and muscle mass). The clinical evaluation of the degree of cellulite was
      made according to the Nürnberger-Muller classification scale.

      Cutaneous ultrasound was performed by an expert dermatologist in the dermatology outpatient
      clinic of the hospital and subsequently assessed blinded. Two skin scans were done for each
      patient, one before starting the treatment and another at the end. The objective data
      collected on each ultrasound were total skin thickness, thickness of the dermis and
      hipodermis, the area of the indentations of the subcutaneous cellular tissue in the dermis
      and changes in the echogenicity of the dermis blinded and independently assessed by two
      researchers, comparing ultrasounds before and after treatment.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Females older than 18, with normal weight ranges in addition to the presence of cutaneous
        non-infectious cellulite (edematous-fibrosclerotic panniculopathy), were recruited for the
        study and to undergo treatment with the multidisciplinary programme.
      
Keywords: Cellulite; Cutaneous ultrasound; PnKCelulitis® program
Pharmacokinetics/Pharmacodynamics of Argatroban Injection in End-Stage Renal Disease Patients Undergoing Hemodialysis
Condition: Kidney Failure, Chronic; Renal Disease, End-Stage
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary goals of this investigation are to provide guidance on how to dose Argatroban in
      patients undergoing hemodialysis and to assess the safety and tolerability of Argatroban in
      hemodialysis patients. The secondary goal of the study will be to assess the adequacy of
      anticoagulation during hemodialysis.
    


Intervention name(s): Argatroban
Intervention type(s): Drug
Intervention MeSH terms: Argatroban
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ESRD; End-stage renal disease; Hemodialysis
The Factors Causing Treatment Failure in Children Receiving Oxygen Therapy With High-flow Nasal Cannula
Condition: High-flow Nasal Cannula; Respiratory Distress; Treatment Failure
Study type: Observational [Patient Registry]

Summary: 
      The goal of this observational study is to identify the variables that predict treatment
      failure in order to identify the patients in which HFNC treatment may fail and not delay the
      transition to advanced respiratory support treatments in these patients.

      The main questions it aims to answer are:

        -  What factors contribute to the failure of HFNC treatment in these children?

        -  What is the frequency of HFNC treatment failure in children with moderate and severe
           respiratory distress? Researchers will compare the group whose HFNC treatment was
           successful with the group whose HFNC treatment failed to identify factors that cause
           treatment failure.
    

Detailed description: 
      Oxygen therapy with a high-flow nasal cannula (HFNC) is a well-tolerated, relatively new,
      non-invasive alternative ventilation treatment modality. On the other hand, HFNC failure
      delays advanced respirator supportive treatments, prolongs hospitalization in the intensive
      care unit, and emergency department, and causes a significant increase in morbidity and
      mortality with hypoxemia, neurological impairment, and/or hemodynamic instability. The
      investigators aimed to identify the variables that predict treatment failure in order to
      identify the patients in which HFNC treatment may fail and not delay the transition to
      advanced respiratory support treatments in these patients.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        1 months-18 years Moderate to severe respiratory distress Oxygen therapy with high-flow
        nasal cannula
      
Keywords: Pediatric; HFNC; Respiratory distress; predictor of failure
Motor and Cognitive Dual Task Performance in Sports
Condition: Task Performance
Study type: Observational

Summary: 
      In this study, it is aimed to examine the dual-task performance of soccer referees. For this
      purpose, it will be investigated whether the motor or cognitive performance of the referees
      changes when dual-task is assigned and also whether there are differences in dual-task
      performance between the referees and athletes with similar training program.
    

Detailed description: 
      In this study, the motor and cognitive dual-task performances of referees will be evaluated.
      It also will be investigated whether the referees prioritize one of the performances, motor
      or cognitive, during the dual-task and whether their role in the competition makes a
      difference compared to athletes. For this purpose, appropriate motor and cognitive tasks were
      determined by considering the roles of the referees during the competition.

      After completing the Demographic Information Form respectively; Edgren Side Step Agility Test
      as motor performance assessment, Multiple Object Tracking (MOT) as cognitive performance
      assessment, and finally Dual-Task evaluation using MOT and Edgren Side Step Agility Test will
      be applied simultaneously. Dual-task costs will be calculated as a percentage of single-task
      for both motor and cognitive tasks.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Soccer referees affiliated with the National Football Federation and athletes with similar
        to soccer referees in terms of sociodemographic and physical characteristics and training
        program.
      
Keywords: Dual-Task Performance; Task- specific Performance; Sports; Agility; Multiple Object Tracking; Referee