bioihbjkbjnl/mcl2 huggingface dataset:
Therapeutic Impact of KT Along With BT in Patients With Chronic Low Back Pain of Sacroiliac Joint Dysfunction
Condition: Sacroiliac Joint Dysfunction
MeSH terms: Joint Diseases; Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This research aimed to determine the impacts of KT and balance exercises in patients with
      CLBP of SIJ dysfunction.
    

Detailed description: 
      The study will be based on a two-arm parallel group randomized control design. thirty
      participants of CLBP of SIJ Dysfunction will be recruited from the Physiotherapy department,
      at Integral University, India. Study objectives and procedure will be properly explained and
      written informed consent will be obtained at the beginning of the study. All the participants
      will be randomly divided into two groups A and B. Experimental group A will receive the hot
      pack, Stretching exercise, and Kinesio taping along with balance training (KBT), and group B
      will receive the hot pack, Stretching exercise, and Balance training (BT) exercise
    

Intervention name(s): Kinesio Taping; Balance Training (BT); Hot Pack and Stretching Exercises
Intervention type(s): Other; Other; Other
Intervention description(s): Kinesio tape with a 5 cm width was used. Participants were positioned on the side lying on the non-involved side with the hip joint of the involved side flexed to 45 degrees and the femur supported in neutral rotation. First, the tape was placed over the area between the ASIS and PSIS to protect the skin. Next, two strips of tape were applied over the first tape to correct anterior innominate rotation. The first piece was applied at the ASIS and pulled firmly to the PSIS in a straight anterior-to-posterior direction. The second piece was applied in an arching manner pulled firmly from the ASIS to the PSIS. the tape was changed once every 3 days; The balance training was performed on the Biodex balance system, participants wwere instructed to stand on a podium and stabilize themselves to keep the cursor in the middle of co-centered circle on the displayed screen/monitor. Stability level of platform was set on eight for first two sessions and then reduced to one level on every two sessions so that in the 9th and 10th session the stability level was four. From session four onwards, the participants performed the limit of stability exercises with Biodex Balance System. The participants performed this exercise protocol two times in each session. Total 12 sessions were given in time period of six weeks.; A hot pack was applied for 20 minutes, stretching exercises were performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Bioavailability and Metabolism of Diet Phenolic Compounds
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims at studying in depth the absorption and metabolism of phenolic compounds of
      olive oil, wine and beer. This study is divided into 2 sub-studies in order to evaluate each
      one of the objectives.
    

Detailed description: 
      The study is divided in two sub-studies to explore each objective.

      One the one hand, a group of people will drink olive oil, or wine, or both. This is done to
      see if combining these two drinks will improve the absorption and bioavailibility of phenolic
      compounds that they contain, promoting by synergy their antioxidant activity at a
      postprandial level. The main compounds studied are the Resveratrol (RSVT), the Hydroxytyrosol
      (HT), tyrosol (TIR) and their metabolits.

      One the other hand, an group of people will drink 3 different beers ( with 3 different
      degrees of alcohol), or wine, in order to study the absorption of TIR in relation to the
      alcohol degree. It also aims at assessing if the gas contained in beer contributes to TIR
      absorption.

      At different times after the administration of drinks, urine and blood samples will be
      collected.
    

Intervention name(s): Administration of olive oil; Administration of red wine; Combination of red wine and olive oil; Water; Dark beer; Light Beer; Alcohol free Beer
Intervention type(s): Other; Other; Other; Other; Other; Other; Other
Intervention description(s): 25 mL of extra virgin olive oil; 150 mL or Red Wine; 150 mL of Red wine + 25 mL of Extra Virgin Olive oil will be administred at the same time; Mineral water will be given as placebo; 250 mL of IPA beer (alcohol 8.5% vol); 250 mL of blonde ale beer (alcohol 4,5% vol); 250 mL of alcohol free beer (alcohol 0.0% vol)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A 40 people group of healthy men and women. Two Cohorts group of 20 healthy volunteers of both genders.
Masking: None (Open Label)
Primary purpose: Health Services Research
A Study Evaluating the Safety of LEO 90105 and Its Vehicle, After Multiple Administration on Intact Skin of Healthy Japanese Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to to investigate the safety of LEO 90105 compared with its
      vehicle after multiple administration (twice daily, 5 days) in healthy Japanese male
      subjects.
    


Intervention name(s): LEO 90105
Intervention type(s): Drug
Intervention description(s): Ointment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Treatment for Teachers With Vocal Fatigue
Condition: Vocal Fatigue; Treatment
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      Teachers are a population at high risk for voice disorders given their occupational demands.
      In a teaching career, a common debilitating symptom among all vocal symptoms experienced is -
      vocal fatigue, impacting teachers' occupational performance and increasing health care costs.
      It is therefore essential to identify potential treatment options to alleviate the symptom of
      vocal fatigue. The purpose of this study is to utilize a body-system level cardiovascular
      training protocol in comparison to traditional voice production training to alleviate the
      symptoms of vocal fatigue.
    


Intervention name(s): Cardiovascular Conditioning Protocol; Voice Production Exercises
Intervention type(s): Behavioral; Other
Intervention description(s): Participants will be randomized to either one of the treatment arms to receive treatment for a period of 4 weeks.; Participants will be randomized to either one of the treatment arms to receive treatment for a period of 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
EP Combined With RFA for Ampullary Neoplasms With Intraductal Biliary Extension
Condition: Ampullary Adenomas
MeSH terms: Neoplasms; Adenoma
Study type: Interventional

Summary: 
      Endoscopic papillectomy is the preferred approach for management of ampullary adenomas.
      Endobiliary radiofrequency ablation (RFA) is an ablative therapy that has been used to treat
      malignant biliary strictures. The aim of this study was to evaluate the safety and efficacy
      of endoscopic papillectomy combined with endobiliary RFA for ampullary neoplasms with
      intraductal biliary extension.
    

Detailed description: 
      Ampullary neoplasms remain rare, with a reported prevalence of 0.04% to 0.12% in autopsy
      studies. , endoscopic papillectomy is now recognized as a safe and reliable alternative to
      surgery for ampullary adenomas and is associated with high success rates (72%-95%), low
      morbidity (10%-30%), and minimal mortality (0.2%-1%). Typically, however, intrabiliary
      extension of the adenoma has been regarded as a contraindication for endoscopic papillectomy.
      Surgical referral is therefore recommended with intraductal extension, particularly when the
      length of extension exceeds 1 cm. Radiofrequency ablation offers a potentially safe and
      effective treatment for malignant biliary strictures. The use of RFA as a primary treatment
      for intraductal dysplasia after endoscopic papillectomy has been shown in few small case
      series to be feasible with the primary limitation of short follow-up periods. The primary aim
      of this study was to describe our experience with RFA in patients with ampullary neoplasia
      and associated intraductal extension who were not surgical candidates.
    

Intervention name(s): Endoscopic Papillectomy; Endobiliary Radiofrequency Ablation
Intervention type(s): Procedure; Procedure
Intervention description(s): A snare devicewas inserted via the working channel, and the endoscopist adjusted the snare to securely grasp the lesion, which was then excised by using standard electrocautery.; The RFA catheter was then placed under fluoroscopic guidance across the distal common bile duct. An ERBE VIO200D generator (ERBE Elktromedizin, Tubingen, Germany) was connected for RFA at 10 W for 90 seconds.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Endoscopic papillectomy; Radiofrequency ablation; Ampullary neoplasms; Intraductal biliary extension
Phase 1 Naltrexone-Bupropion-Methamphetamine Interaction Study
Condition: Methamphetamine Dependence
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is to primarily measure safety and interactions between oral doses of
      Naltrexone/Bupropion and i.v. Methamphetamine.
    


Intervention name(s): placebo; Naltrexone and Bupropion SR
Intervention type(s): Other; Drug
Intervention description(s): matching placebo; 25mg bid/day (NX) 200mg bid/day (BUP)
Intervention MeSH terms: Naltrexone; Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Diagnostic
Reducing Residual Albuminuria in Subjects With Diabetes and Nephropathy With Atrasentan
Condition: Chronic Kidney Disease; Diabetic Nephropathy
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Diabetic Nephropathies; Albuminuria
Study type: Interventional
Phase: Phase 2

Summary: 
      Prospective, randomized, double-blind, placebo controlled, 12-week, multicenter study. The
      objective of the study is to evaluate the efficacy and safety of once daily administration of
      atrasentan tablets compared to placebo in reducing residual albuminuria in Japanese Type 2
      diabetic patients with nephropathy who are treated with the maximum tolerated labeled dose
      for hypertension of a RAS (renin angiotensin system) inhibitor.
    


Intervention name(s): Atrasentan low dose group; Atrasentan high dose group; Atrasentan placebo group
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will take two tablets daily of one of those which are atrasentan low dose, atrasentan high dose or atrasentan placebo for 12 weeks during the treatment period.; Subjects will take two tablets daily of one of those which are atrasentan low dose, atrasentan high dose or atrasentan placebo for 12 weeks during the treatment period.; Subjects will take two tablets daily of one of those which are atrasentan low dose, atrasentan high dose or atrasentan placebo for 12 weeks during the treatment period.
Intervention MeSH terms: Atrasentan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Endothelin Receptor Antagonists; Proteinuria
Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, and tolerability of
      Levomilnacipran ER versus placebo in the treatment of outpatients with major depressive
      disorder.
    


Intervention name(s): Levomilnacipran ER; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Drug: Levomilnacipran ER (flexible dose) Study drug is to be given orally, in capsule form, once daily, for 8 weeks.; Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.
Intervention MeSH terms: Milnacipran; Levomilnacipran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Depression
Manual Therapy and Proprioceptive Neuromuscular Facilitation in Field Hockey Players.
Condition: Hockey Players Whith Lower Back and Hamstring Pain
Study type: Interventional

Summary: 
      Introduction: Field hockey is a contact sport. Semiflexion asymmetric position, along with
      other theories such as the weakness of the extensor muscles of the back or hamstring injury,
      can be causes or aggravating that suelan hockey players suffer back pain. Objectives: To
      observe the effectiveness of manual therapy techniques and post-isometric stretching (PNF)
      after three treatment sessions. In turn, know which of the two treatments have a greater
      benefit and longer. Methods: The population consists of grass hockey players and senior
      category aged between 16-30 years. They were randomly divided into two treatment groups.
      Group 1 corresponded to manual therapy techniques and group 2 to PNF stretching. The study
      duration for each subject was 5 sessions that included 3 treatment and 3 assessments. Each
      evaluation consisted of goniometry, balance test using the Sit and Reach, and Roland Morris
      questionnaire.
    


Intervention name(s): Manual Therapy; Proprioceptive neuromuscular facilitation
Intervention type(s): Other; Other
Intervention description(s): The patient remained lying on the gurney and the treatment was performed in the order set forth below and included: overall bilateral manipulation of L5-S1-Sacroiliac, subsequently decompression hip joint, the tibiofemoral decompression, stretching rotators hip flexion or hip and knee mobilization technique downing head and base of the fibula, tibiofibular-talus tali posteriorización decompression and with the help of a wedge to facilitate technical.; Stretching were conducted in the hamstrings, psoas, adductors, pyramidal, quadriceps and right above.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: low back; manual therapy; stretching
Creating an Artificial Night on Physiological Changes in Preterm Infants
Condition: Physiologic Changes
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Effects of creating an artificial night on physiological changes, weight and feeding
      tolerance in preterm infants.

      Introduction:Nowdays,with medical advances in intensive care increased chance of survival in
      premature infants.One of the major concerns exposure to high light levels in neonate &
      subsequent it is increase in metabolism rate.So,this study was conducted to determine the
      effect of creating an artificial night on physiological changes, weight and feeding tolerance
      in preterm infants.

      Methods: This is a randomized clinical trial dual group study, 38 preterm infants
      (gestational age of 30-34weeks)due to prematurity hospitalized at Ghaem NICU,were evaluated
      within 10 days. Infants were divided into two groups of 1200-1700 and 1701-2200g based on the
      weight and the weight of each group were randomized into artificial night(dark period was
      from 19 to 7 during incubator was covered with linen cloth & light period was from 7 to 19
      removed the cover) and control groups(continuous lighting). Mothers & infants through
      questionnaires,interviews,observation & document completion, changes in physiologic & weight
      befor entering the study & then physiologic changes twice a day,weight & feeding tolerance
      were collected daily.Data were analyzed using spss v.16 software.
    


Intervention name(s): artificial night
Intervention type(s): Other
Intervention description(s): Infants in the intervention group received light cyclic with pattern 12 hours. Light period was from 7 to 19 during which the infants were put in the normal environmental light and dark period was from 19 to 7 during which was the infants' incubator was covered with linen cloth. The vital signsand & arterial oxygen saturation of the infants in the intervention group were controlled before covering the incubator i.e. at 19. Also, the infant's vital signs were again monitored at 7 am.The infant weighed in every day at 7 am during the 10 days of study. Feeding tolerance was daily determined at 8 am, using nasogastric tube or orogastric tube to control residue as well as to review the presence or absence of abdominal distention, vomiting.
Other intervention name(s): intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Omega 3 Fatty Acids on Oxidative Stress in HIV Seropositive Patients
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Introduction: Highly active antiretroviral therapy (HAART) has showed its effectiveness in
      the prevention of complications in seropositive for HIV patients. However, they develop some
      manifestations such as lipodystrophy, dyslipidemia, and glucose intolerance increasing
      cardiovascular risk.

      Clinical trials in general population and in patients on hemodialysis have demonstrated a
      significant reduction in cardiovascular events using fish oil. Omega-3 fatty acids are
      believed to be beneficial in prevention of atherosclerosis reducing lipids levels specially
      triglycerides. Also in general populations it has been described a benefit effect of omega 3
      acids on oxidative stress.

      Objective: to know the effect of omega 3 acids on different markers of oxidative stress in
      seropositive HIV patients.

      Methods: We will perform a randomized parallel controlled clinical trial in seropositive HIV
      patients from 20 to 55 years old on clinical score A1, A2, B1 or B2 who received HAART. They
      will be randomly assigned to receive omega 3 fatty acids 2.4 g (Zonelabs, Marblehead MA) or
      placebo for 6 months. At baseline anthropometric measurements, lipid profile, glucose and
      stress oxidative levels (nitric oxide, malondialdehyde, total glutathion, and lipid
      peroxidation products) will be evaluated.

      Sample size was calculated according to different variables. We selected the biggest one
      calculated for a difference in nitric oxide of 25% after treatment between groups and a
      standard deviation (SD) value of 10µmol/L. Whit this information we obtained a sample size of
      31 patients per group for an 80% statistical power with α= 0.05. Assuming a 15% patient lost,
      a sample size of 35 per group was considered.
    


Intervention name(s): omega 3 fatty acids; placebo
Intervention type(s): Drug; Other
Intervention description(s): omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.; olive oil in similar presentation of omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.
Other intervention name(s): Zonelabs, Marblehead MA; olive oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Seropositive HIV; Omega 3 fatty acids; Oxidative stress
Mindfulness-Based Stress Reduction, Health Education and Exercise
Condition: Age-related Cognitive Decline
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of this research is to examine the effects of four interventions on age-related
      cognitive decline in healthy older adults. The investigators will examine the effects of
      Mindfulness Based Stress Reduction (MBSR) psychotherapy, multi-component intensity-based
      aerobic exercise, and their combination, compared to a discussion group.
    

Detailed description: 
      MBSR teaches mindfulness, or the focusing of attention and awareness, through various
      meditation techniques. Mindfulness meditation practices appear to produce neurocircuitry
      changes that are the reverse of those seen in age-related cognitive decline. It is widely
      available, acceptable to older people, and carries minimal risk of side effects or adverse
      events. Exercise - specifically, intense, multi-component exercise - also appears to affect
      brain structure and function and improve cognitive performance.

      The investigators will randomize 580 non-demented healthy adults aged 65 to 84 to one of four
      conditions: MBSR alone, exercise alone, MBSR + exercise, or a health education discussion
      group control condition.

      The study will consist of a 6-month acute intervention phase with weekly visits followed by a
      12-month maintenance phase with weekly or monthly visits and other prompts to maintain
      intervention behaviors.

      Assessments include cognitive tests, biomarkers, neuroimaging assessments, functional
      assessments to examine real-world benefits of the interventions, and other behavioral
      assessments to characterize participants and pave the way for further exploratory analyses.
    

Intervention name(s): MBSR; Exercise; Health Education
Intervention type(s): Behavioral; Behavioral; Behavioral
Other intervention name(s): Mindfulness-Based Stress Reduction; Multi-component intensity-based exercise
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise; Mindfulness; Education; Elderly
Exposure to Potential Cytochrome P450 Pharmacokinetic Drug-Drug Interactions Among Osteoarthritis Patients: Incremental Risk of Multiple Prescriptions
Condition: Chronic Low Back Pain
MeSH terms: Osteoarthritis; Back Pain; Low Back Pain
Study type: Observational

Summary: 
      Using a retrospective analysis of a large commercial claims database and a Medicare database,
      the investigators evaluated DDEs that have the potential to cause DDIs among chronic low back
      pain (cLBP) patients on long-term opioid analgesia, which metabolizes through the CYP450
      enzyme system, concomitant with other CYP450-metabolized drug(s).
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        retrospective chronic low back pain patients taking opioids
      
Keywords: retrospective chronic low back pain