bioihbjkbjnl/mcl2 huggingface dataset:
Anterior Prolapse Repair With and Without Graft Augmentation
Condition: Pelvic Organ Prolapse
MeSH terms: Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      This is a randomized control trial comparing anterior colporrhaphy with augmentation with
      dermal allograft (ARCUS) to anterior colporrhaphy with a suture-based repair (native tissue).
      Patients were randomized to one treatment and then were followed post-operatively for 7-10
      years. Prior to surgery patients had a POPQ vaginal prolapse exam and completed a quality of
      life questionaire (PFDI). They had a repeat POPQ exam and quality of life questionaires at
      their post-op operative visits. We compare recurrent prolapse rates between these 2 groups.
    

Detailed description: 
      Objective: To determine whether dermal allograft (ARCUS) reduces anterior prolapse recurrence
      at 1 and 7-10 years post-operatively. Our central question is whether we can reduce the rate
      of rate of anterior compartment prolapse recurrence after surgical repair, is the recurrence
      rate reduced with allograft use, and does this benefit hold up over time?

      Methods: Patient will be randomized by computer generated block randomization to native
      tissue (suture based) anterior colporrhaphy or colporrhaphy with graft (ARCUS) usage. Neither
      patients nor surgeons will be blinded due to the nature of the surgery. Patients will be
      followed for 7-10 years post-operatively. Participants will complete a POPQ exam and the PFDI
      (Pelvic Floor Distress Inventory) questionnaire pre-operatively. Patients will return for a
      POPQ exam at 1 year post-operatively and complete the PFDI (Pelvic Floor Distress Inventory)
      and PISQ (Sexual Function for Women with: POP, Urinary Incontinence and/or Fecal
      Incontinence) questionnaires. Patients will be asked to return to the office for a research
      visit 7-10 years post-operatively for a POPQ exam and to complete quality of life
      questionnaires including PFDI 20 (Pelvic floor distress inventory), PISQ-R (Sexual Function
      for Women with: POP, Urinary Incontinence and/or Fecal Incontinence, Revised), and PGI
      (Patient global assessment of improvement).
    

Intervention name(s): dermal graft (ARCUS repliform) for anterior colporrhaphy; suture based anterior colporrhaphy
Intervention type(s): Procedure; Procedure
Intervention description(s): At the time of surgery patients were randomized to anterior colporrhaphy with dermal graft augmentation; At the time of surgery patients were randomized to anterior colporrhaphy with a suture based repair
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pelvic organ prolapse, vaginal graft
Effect of High Caloric Intake at Lunch Against Dinner on Weight Loss
Condition: Obesity; Overweight
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      The purpose of the present study is to evaluate the effect of consuming higher caloric intake
      at lunch in contrast to dinner on weight loss of obese and overweight female adults when they
      are in a multidisciplinary weight loss plan .
    


Intervention name(s): Lunch as main meal(LM)+ Diet; Dinner as main meal(DM)+ Diet
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects are asked to have high caloric intake at lunch and low caloric intake at dinner, while they are on a multidisciplinary weight loss plan for 12 weeks.; Subjects are asked to have high caloric intake at dinner and low caloric intake at lunch, while they are on a multidisciplinary weight loss plan for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Meal pattern; weight loss; high caloric intake; Dinner; Lunch
Neurophysiology of Weakness and Exercise in Rotator Cuff Tendinopathy
Condition: Acute Pain; Atrophic; Goals; Impairment; Infiltration; Injury; Muscle Weakness; Pain; Pathology; Shoulder Pain; Syndrome; Tendinopathy
MeSH terms: Shoulder Pain; Tendinopathy; Muscle Weakness; Acute Pain; Asthenia; Atrophy
Study type: Interventional

Summary: 
      The purpose of this study is to examine deficits in activation and motor patterns, as well as
      central drive in patients with rotator cuff tendinopathy. There are three specific aims: (1)
      determine the effect of acute pain relief on rotator cuff muscle activation in patients with
      rotator cuff tendinopathy, (2) determine the effect of exercise on rotator cuff muscle
      activation in patients with rotator cuff tendinopathy, and (3) compare rotator cuff muscle
      activation between patients with rotator cuff tendinopathy and healthy controls.
    

Detailed description: 
      The long-term goal of our research agenda is to identify the mechanisms associated with
      rotator cuff tendinopathy (impingement syndrome) and subsequently evaluate novel treatment
      strategies that address these mechanisms. The objectives of this application are to study the
      muscle patterns in patients with rotator cuff tendinopathy as well as the effects of both
      pain and exercise on these patterns. Our first hypothesis is that pain relief from a shoulder
      injection will result in increased rotator cuff activity. Our second hypothesis is that
      patients with tendinopathy will demonstrate improved rotator cuff muscle activity following a
      six-week exercise program and that this improvement will be higher in patients that respond
      favorably to treatment. Our final hypothesis is that patients with cuff tendinopathy will
      show decreased rotator cuff activity compared to healthy subjects. The investigators plan on
      addressing these hypotheses using several novel techniques for muscle activity assessment.
    

Intervention name(s): Subacromial injection; Physical Therapy
Intervention type(s): Procedure; Other
Intervention description(s): A subacromial injection consisting up 6 cc 0.5% Marcaine with Epinephrine and 1 cc DepoMedrol will be administered.; A standardized six-week exercise protocol supervised by a physical therapist
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: address; atrophic; base; clinical; cost; data; disability; effectiveness; attention; biofeedback; electrical stimulation; electromyography; exercise; exertion; health care service utilization; improved; injection of therapeutic agent; innovation; intervention; knowledge; local anesthetics; measures; modeling; motor; motor control; muscle; neuroadaptation; neurophysiology; novel; outcome; outcome measure; pain inhibition; patients; pattern; programs; public health relevance; rehabilitation strategy; relating to nervous system; reporting; research; rotator cuff; shoulder; staging; strength training; success; systematic review; techniques; testing; time; training; treatment strategy; United States; work
The 'Wearing Off' Effect of DMT
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      This is a non-interventional, cross-sectional, qualitative study in which patients diagnosed
      with MS and clinicians with experience treating MS will be interviewed regarding patient
      experiences with the wearing off effect from ocrelizumab, natalizumab, and ofatumumab
    


Intervention name(s): ocrelizumab; natalizumab; ofatumumab
Intervention type(s): Other; Other; Other
Intervention description(s): Non-interventional, cross-sectional, qualitative study. There is no treatment allocation. Patients prescribed with Disease-modifying therapy in the commercial setting are eligible to enroll into this study.; Non-interventional, cross-sectional, qualitative study. There is no treatment allocation. Patients prescribed with Disease-modifying therapy in the commercial setting are eligible to enroll into this study.; Non-interventional, cross-sectional, qualitative study. There is no treatment allocation. Patients prescribed with Disease-modifying therapy in the commercial setting are eligible to enroll into this study.
Other intervention name(s): Ocrevus; Tysabri; Kesimpta
Intervention MeSH terms: Ofatumumab; Ocrelizumab; Natalizumab
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adult patients diagnosed with MS and clinicians with experience treating MS from Germany,
        UK, and US
      
Keywords: Multiple Sclerosis; MS; ocrelizumab; Ocrevus; natalizumab; Tysabri; ofatumumab; Kesimpta; NIS
Effect of Antioxidants on Oxygen Induced Vasoconstriction in Lipopolysaccharide (LPS) Induced Inflammatory Model in Humans
Condition: Healthy
Study type: Interventional

Summary: 
      Oxidative stress has been implicated in playing a pathogenic role in many disease processes,
      especially in age-related disorders. It has been hypothesized that antioxidative agents such
      as vitamins and minerals, which are capable of scavenging free radicals, may reduce oxidative
      stress and may, in turn, be beneficial for patients with age-related disorders. Based on this
      hypothesis, several different combinations of vitamins have been introduced, all targeting at
      reducing oxidative stress. However, the in-vivo determination of the antioxidative properties
      of a certain drug or vitamin combination are hard to determine. In the current study, the
      researchers propose to investigate the effect of VITAMAC®, a combination of vitamins and
      minerals, in a systemic in-vivo inflammation model.

      In the present study, the infusion of LPS, which is a cell wall component of Gram-negative
      bacteria and a major mediator in the pathogenesis of septic shock, will be used as a
      standardized experimental model of systemic inflammation in humans. Given that inflammation
      is associated with enhanced oxidative stress and widespread endothelial dysfunction, the LPS
      model is well suitable for determination of the antioxidative effects of VITAMAC®. As a main
      outcome parameter, the vascular reactivity of retinal vessels to systemic hyperoxia (induced
      by breathing 100% oxygen) will be tested in presence or absence of the antioxidant
      combination.
    


Intervention name(s): Vitamin and mineral supplement; Vitamin and mineral supplement; Placebo; 100% Oxygen; Escherichia coli Endotoxin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 1 capsule/day in the morning for 14 days, containing: Lutein 12mg, Vitamin C 300mg, Zinc 10mg, Ginko Biloba 10mg, Flavonoids 25mg, Fish oil 300mg; 1 capsule/day in the evening for 14 days, containing: Zeaxanthin 5mg, Vitamin E 60mg, Copper 1mg, Selene 20µg, Ginko Biloba 10mg, Flavonoids 25mg, Alpha Lipon acid: 150mg; 2 capsules/day for 14 days; breathing of 100% O2 for 30 minutes on both study days; Escherichia coli Endotoxin (LPS, US Standard Reference Endotoxin, dose: 2 ng/kg bodyweight (corresponding to 20 IU/kg), i.v. bolus on both study days.
Other intervention name(s): Vitamac Day; LPS (US Standard)
Intervention MeSH terms: Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Endotoxin, Escherichia Coli; Retina; Regional Blood Flow
Phase 2B Dose-Ranging Study of PAC113 Mouthrinse in HIV Seropositive Individuals With Oral Candidiasis
Condition: Oral Candidiasis
MeSH terms: Candidiasis; HIV Seropositivity; Candidiasis, Oral
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the optimal dose of PAC113 mouthrinse for treatment
      of oral candidiasis in HIV seropositive patients.
    

Detailed description: 
      This is a randomized, examiner-blinded, positive-controlled, parallel design clinical trial,
      which features 4 treatment arms. Forty-five (45)* HIV positive subjects per treatment arm
      will be recruited for 180 subjects total. The study includes 5 visits: a screening visit, a
      14-day treatment phase with a baseline visit on Day 1, a Day 7 visit, a post-treatment visit
      5 days after the last dose, and follow-up visit. During the screening visit subjects will be
      assessed for study eligibility. Eligible subjects will be randomized to 1 of the following
      treatment arms:

      A. 0.15% PAC-113 mouthrinse (5 mL 4 times daily [q.i.d.]); B. 0.075% PAC-113 mouthrinse (5 mL
      q.i.d.); C. 0.0375% PAC-113 mouthrinse (5 mL q.i.d.); D. Nystatin oral suspension (100,000
      units/mL; 5 mL q.i.d.) Subjects will be evaluated clinically for safety and severity of
      clinical signs and symptoms of oral candidiasis at baseline (Day 1), Day 7, Day 19 (5 days
      post-treatment) and Day 28 (follow-up visit). Subjects will also have a microbiological
      analysis performed at screening, and at Days 7, 19 and 28.
    

Intervention name(s): PAC113
Intervention type(s): Drug
Intervention description(s): PAC113 mouthrinse 0.15%; 0.075%; 0.0375% QID for 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: oral candidiasis
Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study)
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      To assess efficacy and safety, including immunogenicity of BAX 855 administered as
      prophylaxis and as on-demand therapy in adult and adolescent (12-65 years) previously treated
      patients (PTPs) with severe hemophilia A To determine the pharmacokinetic (PK) parameters of
      BAX 855.
    


Intervention name(s): Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method; PEGylated Recombinant Factor VIII; PEGylated Recombinant Factor VIII; PEGylated Recombinant Factor VIII
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Pharmacokinetic (PK) evaluation of ADVATE; Pharmacokinetic (PK) evaluation of BAX 855; Prophylaxis treatment; On-demand treatment
Other intervention name(s): ADVATE; BAX 855; BAX 855; BAX 855
Intervention MeSH terms: Factor VIII; BAX 855
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Early Enteral Nutritional Supplementation on Patients With Oral and Oropharyngeal Cancer Undergoing Radio(Chemo)Therapy After Surgical
Condition: Malnutrition
MeSH terms: Oropharyngeal Neoplasms; Malnutrition
Study type: Interventional
Phase: Phase 2

Summary: 
      The target population in the present study is Chinese patients with oral and oropharyngeal
      cancer who plan to receive radio(chemo)therapy after surgical resection in the outpatient
      department. Investigators hypothesize that early enteral nutrition intervention, which is
      initiated 2 weeks before the start of postoperative radio(chemo)therapy treatment and added
      on demand during radiotherapy, will improve patients' nutritional status, tolerability to the
      radio(chemo)therapy, quality of life, and other clinical outcomes compared to commencement of
      oral nutritional supplements during the course of irradiation treatment. There are two
      cohorts in this trial, cohort 1 included patients with oral nutritional supplements and
      cohort 2 included patients with tube feeding (nasogastric tube or percutaneous endoscopic
      gastrostomy).
    

Detailed description: 
      This clinical trial will be conducted in a single-center, prospective, and randomized manner.
      In this protocol, the standard radio(chemo)therapy duration is 6-7 weeks. Early enteral
      nutrition intervention (EEN) refers to starting enteral nutrition intervention 2 weeks before
      post-operative radio(chemo)therapy begins and stopping this intervention when post-operative
      radio(chemo)therapy completes. Standard enteral nutrition intervention (SEN) refers to
      starting of enteral nutrition intervention on demand during (chemo)radiotherapy. Nutritional
      supplementation was given either through the oral route (Cohort 1) or tube feeding
      (nasogastric tube or percutaneous endoscopic gastrostomy, cohort 2). Dietitians will design
      meal plans for both groups of subjects so that their normal diets will provide 25-30
      kcal/d/kg body weight in addition to nutritional supplements.
    

Intervention name(s): Early nutritional intervention
Intervention type(s): Dietary Supplement
Intervention description(s): Early nutritional intervention (Ensure) was given two weeks before radiotherapy. Ensure 3 times per day, Mixing 55.8 g or 6 spoons of Ensure with 190 mL of warm water.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Cohort 1: nutritional supplements are given through oral route Cohort 2: nutritional supplements are given by tube feeding
Masking: None (Open Label)
Primary purpose: Supportive Care
5-azacytidine Treatment Versus 5-azacytidine Followed by Allogeneic Stem Cell Transplantation in Elderly Patients With Myelodysplastic Syndrome (MDS)
Condition: Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia
MeSH terms: Preleukemia; Leukemia, Myelomonocytic, Chronic; Leukemia, Myelomonocytic, Juvenile; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      5-azacytidine treatment prolongs survival in patients with myelodysplastic syndrome (MDS),
      but does not cure the disease. Allogeneic stem cell transplantation is a curative treatment
      option but is associated with a high risk treatment-related morbidity and mortality. In the
      current trial allogeneic stem cell transplantation will be compared to 5-azacytidine only
      treatment according to donor availability in elderly patients with MDS (55-70 years).
    

Detailed description: 
      5-azacytidine treatment prolongs survival in patients with myelodysplastic syndrome (MDS),
      but does not cure the disease. Allogeneic stem cell transplantation is a curative treatment
      option but is associated with a high risk treatment-related morbidity and mortality.
      Dose-reduced conditioning prior transplantation allows also treatment of elderly patients
      with MDS. In the current trial allogeneic stem cell transplantation will be compared to
      5-azacytidine only treatment according to donor availability in elderly patients with MDS
      (55-70 years).
    

Intervention name(s): allogeneic stem cell transplantation; 5-azacytidine until progress
Intervention type(s): Procedure; Procedure
Intervention description(s): donor available, after 4 cycles 5-azacytidine allogeneic stem cell transplantation after reduced conditioning; if no donor available 5-azacytidine until progress or toxicities
Intervention MeSH terms: Azacitidine
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MDS; CMML; allogeneic stem cell transplantation; 5-azacytidine
Beijing Indoor Air Purifier Intervention Study
Condition: Pulmonary Disease
MeSH terms: Lung Diseases
Study type: Interventional

Summary: 
      This study aimed to assess the impact of air filtration on indoor air quality and
      cardio-pulmonary health in residents living in high outdoor pollution settings in Beijing.
    


Intervention name(s): air purifier
Intervention type(s): Other
Intervention description(s): filtration units randomly allocated to active- and sham-mode in 20 recruited households for four weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Exploratory Study to Investigate the Reparative and Regenerative Potential of Alemtuzumab in Relapsing-Remitting Multiple Sclerosis Patients Participating in the CARE MS I and MS II Studies
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Observational

Summary: 
      The primary goal of this study will be to explore the reparative and regenerative potential
      of alemtuzumab in RRMS patients who are participating in the CARE MS I and CARE MS II studies
      using conventional and non-conventional MRI sequences.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with RRMS who are participating in the CARE MS I and CARE MS II studies and are
        receiving either alemtuzumab or interferon beta-1a SC
      
Keywords: Patients with RRMS who are participating in the CARE MS I and CARE MS II
Effects of Vibration Therapy in Addition to Routine Physical Therapy in Patients With Diabetic Neuropathy
Condition: Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional

Summary: 
      The study is aimed to determine the effects of sole-foot vibration therapy on pain intensity,
      static and dynamic balance, functional status and satisfaction to the intervention applied on
      patients with peripheral neuropathy due to type 2 diabetes mellitus.
    

Detailed description: 
      Peripheral Diabetic Neuropathy has disastrous effects on human body. It causes impairment
      which makes normal functioning and activity of daily life difficult. Vibration therapy
      improves neural mechano-sensitivity to promote movement and function.

      In Pakistan, researches have been conducted only on Whole-body vibration and no data is
      available on foot-sole vibration therapy which is convenient to apply and appropriate for
      patients as there will be no fear of fall associated during treatment. Therefore, the aim of
      this study is to analyze the effects of vibration therapy, applied locally on foot, on pain
      management, balance adjustment, function and satisfaction to treatment in patients with
      diabetic neuropathy.
    

Intervention name(s): Routine Physical Therapy; Vibration Therapy
Intervention type(s): Other; Other
Intervention description(s): The Routine Physiotherapy treatment will include Transcutaneous Electrical Nerve Stimulation, Hot pack, Range of Motion (ROM) Exercises and Muscle Strengthening Exercises; Vibration Therapy will include a vibration device of brand Manipol, model number RK-001. It has 360 degree off-centered axis with a frequency of 2500 times per minute. It will be applied on sole of the foot for about 15 mins.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Vibration Therapy; Diabetic Neuropathy; Pain; Balance; Functional Disability; Patient satisfaction; Routine Physical Therapy