bioihbjkbjnl/mcl2 huggingface dataset:
The Effectiveness of Dry Needling and Classic Physiotherapy Programs in The Patients Suffering From Chronic Low Back Pain Caused by Lumbar Disc Hernia
Condition: Metabolic Syndrome; Physical Activity; Quality of Life
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      Aim: This study was planned for comparing physical activity levels, nutrition quality and
      quality of life of the individuals that are diagnosed with and without metabolic syndrome
      (MetS) and that live in the Turkish Republic of Northern Cyprus (TRNC).

      Method: 1200 individuals in total, in which (n: 660) individuals diagnosed with MetS and
      (n:660) individuals not diagnosed with MetS, participated in this study. Socio-demographic
      characteristics of the individuals that participated the study were registered with a survey
      form. The long form of the International Physical Activity Questionnaire was used for
      determining physical activity levels of the individuals; whereas total numbers of daily steps
      were carried out with pedometer. The 14-item Mediterranean Diet Adherence Screener (MEDAS)
      was used for the assessment of dietary habits, Nottingham Health Profile (NHP) was used for
      the assessment of health-related qualities of life of individuals and Beck Depression
      Inventory (BDI) was used for the assessment of depression. In addition, biochemical analysis
      and anthropometric measurements of individuals were also taken.
    


Intervention name(s): Dry Needling Application; Classic Physiotherapy Program
Intervention type(s): Other; Other
Intervention description(s): Dry needling was performed on active and/or latent TPs at Gluteus Medius, Quadratus Lumborum, Multifidus, Erector Spinae muscles of the subjects in the study groups without applying any local anesthetic substance. The needles were applied with a 90º angle for Multifidus, Quadratus Lumborum and Gluteus Medius muscles; while they were applied with a 45º angle for Erector Spinae muscles. Thin stainless steel needles of 0.25x0.40 mm and 0.30x0.60 mm were applied in infiltration form on the TP through many points in conformity with the injection technique.; Hot-pack was applied for 20 minutes. Burst TENS was applied on the lumbar regions of the cases of the control group paravertebrally with 4-electrode reusable silicone rubber. The dimensions of electrode is 5x5cm. Pulse width was set for 100 µsn, pulse frequency was set for 2 Hz, cycle time is set for 0.5 seconds and the amplitude was increased until visible muscle contraction was reached. If the muscle contraction is lost during the session, the amplitude was increased again.
Ultrasound was paravertebrally applied to the lower back regions of the subjects. The treatment was applied with 1 MHz frequency, 1.5 W/cm2 power, for 6 minutes a day, for 10 sessions in total with direct contact with the patient's skin.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Nutrition; Public Health
A Study to Evaluate the Effects of a Single and Multiple Oral Doses of GLPG3121 in Adult, Healthy, Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a first-in-human, Phase I, randomized, double-blind, placebo controlled,
      dose-escalation study to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics of GLPG3121 after oral single ascending doses (SAD) of GLPG3121 (part 1) and
      after oral multiple ascending doses (MAD) for 13 days of GLPG3121 (part 2) in healthy male
      subjects.
    


Intervention name(s): GLPG3121 SAD; Placebo SAD; GLPG3121 MAD; Placebo MAD
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): GLPG3121 oral suspension, single ascending doses; Placebo oral suspension; GLPG3121 oral suspension, multiple ascending doses, daily for 13 days; Placebo oral suspension, daily for 13 days
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Testing the Effect of Exercise Intervention Using a SMART Design.
Condition: Fat Burn
Study type: Interventional

Summary: 
      Exercise is the most effective way on reducing visceral adipose tissue (VAT), which is
      strongly linked with obesity to hypertension, cardiovascular disease, and insulin resistance.
      However, the current exercise dosage for reducing VAT cannot be accurately quantified. The
      aims of this study are to develop and test the optimal exercise dosage and sequence for
      reducing VAT in overweight and obese community residents. Purposive sampling will be used to
      enroll at least 206 participants aged 40-65 years and body fat more than 30% without diet
      control from 2 community centers in southern Taiwan. The project will use the sequential
      multiple assignment randomized trial (SMART) design to conduct a 16-week 2-stage (each for
      8-weeks) adaptive exercise intervention for community residents. In the first stage,
      participants will be randomized into groups performing 8 weeks either moderate intensity of
      aerobic exercise or interval training 3 times per week. Participants whose VAT does not
      decrease by over 3%, measured using a body composition analyzer, compared with the baseline
      will be 1:1 rerandomized into groups with aerobic exercise combined with resistance exercise
      or received the exchange of first stage treatment (interval training or aerobic exercise) in
      the second stage. Those with substantial response to the first-stage intervention (VAT
      reduction of more than 3%) will continue to receive the same exercise treatment until 16
      weeks. Linear mixed model, weighted and replicated regression will be used to identify the
      optimal sequence of exercises for the greatest reduction in VAT. The findings can assist
      clinical health workers to develop exercise prescriptions for effectively reducing VAT, and
      help community residents reduce VAT through exercise to achieve the health promotion.
    


Intervention name(s): exercise
Intervention type(s): Behavioral
Intervention description(s): intervention groups provided different sequential modality of exercise
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Participants will be randomized with 1:1 equal allocation at baseline to one of two first-stage interventions (8 weeks aerobic exercise (AE) or interval training). Those who exhibit early signs of nonresponse determined by a tailoring variable (reduced (visceral adipose tissue (VAT) < 3%) will then be rerandomized to one of two second-stage interventions (AE + RE (resistance exercise) vs interval training or AE), also with 1:1 equal allocation, whereas those who have a significant response to the first-stage intervention will continue to receive the same exercise treatment until 16 weeks.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: sequential multiple assignment randomized trial; exercise; visceral adipose tissue
Pharmacokinetics of BIA 9-1067 in Subjects With Hepatic Impairment
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics (PK) of BIA 9-1067 in patients
      with moderate chronic hepatic impairment and in matched healthy subjects.
    

Detailed description: 
      This was an open-label, single-dose, parallel-group, in-patient, nonrandomized study
      conducted in 8 patients with moderate chronic hepatic impairment and in 8 healthy matched
      subjects matched by origin, age, sex, weight, and smoking habits.

      Each hepatic impaired patient and matched healthy subject participated in the study for
      approximately one month, including a 21-day screening period and a 4-day/4-night inpatient
      period. The inpatient period covered the period from Day -1 to Day 4 morning (through 72
      hours after administration). The final study evaluation was performed for all subjects in the
      morning of the day of discharge, Day 4.
    

Intervention name(s): BIA 9-1067
Intervention type(s): Drug
Intervention description(s): Opicapone, OPC
Other intervention name(s): Opicapone
Intervention MeSH terms: Opicapone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BIA 9-1067; Opicapone; catechol-O-methyltransferase (COMT)
Oral Ketorolac for Arthroscopic Rotator Cuff Repair
Condition: Rotator Cuff Tear; Postoperative Pain
MeSH terms: Pain, Postoperative; Rotator Cuff Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      1. The investigators aim to examine the use of IV and oral ketorolac as an adjunctive agent
           to the standard of care pain protocol for postoperative pain control following
           arthroscopic rotator cuff repair.

        2. The investigators hypothesize that the use of IV and oral ketorolac in addition to the
           standard of care pain protocol will reduce postoperative opioid consumption following
           arthroscopic rotator cuff repair.
    


Intervention name(s): Ketorolac
Intervention type(s): Drug
Intervention description(s): Oral Ketorolac
Intervention MeSH terms: Ketorolac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rotator Cuff Tear; Postoperative Pain
Glasdegib Absolute Bioavailability Study
Condition: Healthy Volunteer Study
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is intended to estimate the absolute bioavailability of Glasdegib by comparison of
      the pharmacokinetic exposures following administration of an oral, single dose 100 mg tablet
      vs. an IV infusion of a 50 mg IV dose in the fasted state in a crossover fashion to healthy
      volunteers.
    


Intervention name(s): Glasdegib Oral Tablet; Glasdegib IV infusion
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive a single 100 mg oral tablet of glasdegib under fasted conditions, either in study period 1 or 2, depending on randomization.; Subjects will receive a 50 mg IV infusion of glasdegib over approximately 1.25 hours, in the fasted state, in either period 1 or 2 based on randomization.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Glasdegib; PF-04449913; Pharmacokinetics; Bioavailability
A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss
Condition: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluate the ability of injections of Ji Gami(TM) and Ji Gami(TM) DO to induce hair growth in
      male and female subjects with hair loss.
    


Intervention name(s): Autologous cultured dermal and epidermal cells
Intervention type(s): Biological
Intervention description(s): A piece of occipital scalp is taken from the subject. The epidermal and dermal cells from this tissue are expanded in culture. The cells are then harvested and, for certain types of product, combined. These cells are then injected into the balding area of the scalp of the original subject.
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Androgenetic Alopecia; Male Pattern Baldness; Female Pattern Baldness; Hair Loss; Baldness
Effects of SAMe in Patients With Alcoholic Liver Disease
Condition: Liver Disease, Alcoholic
MeSH terms: Liver Diseases; Liver Diseases, Alcoholic
Study type: Interventional
Phase: Phase 3

Summary: 
      Prior studies in animal models have established that the pathogenesis of alcoholic liver
      disease (ALD) is regulated in part by the effects of chronic alcohol abuse on hepatic
      methionine metabolism. The hypothesis of the clinical study was that provision of the
      methionine metabolite S-adenosylmethionine (SAM) would correct abnormal hepatic methionine
      metabolism thereby effectively treating ALD. The two goals of the clinical research were a)to
      determine the clinical relationship of aberrant hepatic methionine metabolism to ALD by
      comparisons of patterns of serum methionine metabolites in groups of ALD patients, alcoholics
      without liver disease, and normal healthy subjects, and b) to determine the treatment effects
      of SAM on patterns of serum methionine metabolites and on the histopathology and biochemical
      features of liver injury in ALD patients.
    

Detailed description: 
      We assessed a total of 297 potential ALD candidates, from whom 40 were enrolled in the study.
      In addition, we enrolled 26 gender matched active alcohol drinkers without liver disease (AD)
      and 28 age and gender matched healthy control subjects (HS). Of the original 40 ALD subjects
      who provided initial enrollment data, 3 declined to proceed with the trial. Therefore, 37 ALD
      patients were randomized to receive SAM at a dose of 400 mg or placebo three times daily for
      24 weeks. However 11 of these dropped out after initial evaluation, leaving 26 ALD patients,
      13 in each arm, who completed the 24 week trial.
    

Intervention name(s): S-adenosylmethionine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Alcoholic liver disease patients received drug at dose of 400 mg three times daily for 24 weeks.; Alcoholic liver disease patients received identical size and shape sugar pill placebo three times daily for 24 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Alcoholic Liver Disease (ALD); S-adenosylmethionine; SAMe
The Effect of a Musical Intervention on Stress Response to Venepuncture
Condition: Pain; Stress, Physiological
Study type: Interventional

Summary: 
      Randomised Crossover Trial in Preterm Infants less than 32 weeks to assess Music therapy and
      sucrose versus sucrose on stress
    

Detailed description: 
      The purpose of this study is to assess whether the use of music therapy as a
      non-pharmacological intervention around the time of venepuncture significantly decreases the
      stress response of a stable preterm neonate, as measured by salivary cortisol levels .

      The secondary aim of this study is to analyse the effect of music therapy on the EEG, and
      vital signs of the stable preterm neonate.
    

Intervention name(s): Music therapy
Intervention type(s): Other
Intervention description(s): The musical intervention will be played for ten minutes prior to venepuncture
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Neonate; preterm; pain; music; EEG; venepuncture
A 2-part Study to Investigate the Effect of Macitentan in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of macitentan at steady state on the
      pharmacokinetic (PK) of a single dose of riociguat and sildenafil (Part A); and rosuvastatin
      (Part B) when co-administered to healthy male participants under fasted conditions.
    


Intervention name(s): Macitentan; Sildenafil; Riociguat; Rosuvastatin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Macitentan will be administrated as film-coated tablet in Part A and Part B.; Sildenafil will be administrated as film-coated tablet in Part A.; Riociguat will be administrated as film-coated tablet in Part A.; Rosuvastatin will be administrated as film-coated tablet in Part B.
Other intervention name(s): JNJ-67896062-AAA; Revatio; Adempas; Crestor
Intervention MeSH terms: Sildenafil Citrate; Rosuvastatin Calcium; Macitentan; Riociguat
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study Assessing Safety and Effectiveness of BORTEZOMIB Combination Therapy (Bortezomib + Doxorubicin Hydrochloride + Dexamethasone) in Previously Untreated Multiple Myeloma Patients
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether doxorubicin HCL liposome injection,
      bortezomib, and Dexamethasone in combination, are effective in previously untreated multiple
      myeloma patients. Bortezomib inhibits the function of proteasomes, a novel mechanism of
      action.
    

Detailed description: 
      This was a single-arm, open-label, Phase II multi-centre study in Canada only. A total of 50
      newly diagnosed multiple myeloma patients who were eligible for stem cell transplant were
      targeted for recruitment to this study. Combination doxorubicin HCL liposome injection,
      bortezomib and dexamethasone induction therapy was given for 4 cycles in preparation for stem
      cell collection and transplant. As remission status after induction and prior to the first or
      second auto-transplant has been shown to be the major determinant of both event free and
      overall survival in multiple myeloma patients, the goal has been to improve response rates
      through the use of various combinational approaches. As such, the objective of the present
      study was to test the hypothesis that treatment with this regimen could result in a higher
      complete + near complete response rate (CR + nCR) prior to stem cell transplant, than
      obtained with current regimens, and then to confirm the response rate post-transplant. Safety
      was evaluated using adverse event reportings, clinical laboratory tests and tests for cardiac
      function (multiple-gated acquisition scan/echocardiogram and electrocardiogram). Four 21-day
      cycles of combination induction therapy consisting of 1.3 mg/m2 bortezomib (given i.v. Days
      1, 4, 8, 11) + 30 mg/m2 Doxil/Caelyx (given i.v. Day 4) + 40 mg Dex (given po Days 1-4, 8-11,
      15-18 Cycle 1 only; Days 1-4 Cycles 2-4).
    

Intervention name(s): Bortezomib + pegylated liposomal doxorubicin HCl + dexamethasone
Intervention type(s): Drug
Intervention MeSH terms: Dexamethasone; Doxorubicin; Liposomal doxorubicin; Bortezomib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple myeloma; response rate; peripheral stem cell transplant; safety; tolerability
Randomised Controlled Trial of Unsolicited Occupational Therapy in Community-Dwelling Elderly
Condition: Disability; Occupational Therapy
Study type: Interventional

Summary: 
      In this study we aim to assess whether unsolicited occupational therapy compared to no
      therapy can decelerate the increase in disability in high-risk elderly.
    

Detailed description: 
      Community-dwelling elderly, and particularly the oldest old, are generally viewed as highly
      susceptible to the 'inverse care law'. That is, those in greatest need for preventive
      assessment and surveillance have the highest potential benefit but are most likely to be
      missed. Hence, active case-finding and close follow-up might be an important strategy for
      maintaining the health, independence, and well-being of very elderly people who are at a
      particularly high risk.

      In this study we aim to assess whether unsolicited occupational therapy compared to no
      therapy can decelerate the increase in disability in high-risk elderly. Subjects in the
      intervention group will be visited by an occupational therapist who provides training and
      education about assistive devices that are already present and will give recommendations and
      information about procedures, possibilities, and costs of assistive devices and
      community-based services. Control subjects will not be visited by an occupational therapist.

      The primary outcome measure of the trial will be the score on the Groningen Activity
      Restriction Scale (GARS). Secondary outcome measures will be well-being and feelings of
      loneliness.
    

Intervention name(s): occupational therapy
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: disability; occupational therapy
SPACE MAINTAINERS EFFECTS ON ORAL MİCROFLORA
Condition: Orthodontic Appliance Complication; Lactobacillus Infection; Dental Caries in Children; Streptococcus, Other Specified Group
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      Space maintainers are used to preserve the space after premature loss of teeth but they could
      effect some factors that play a role in caries formation. The research aimed to assess the
      impacts of removable and fixed space maintainers on the salivary pH, flow rate, and
      Streptococcus mutans, Lactobacillus carriage.
    

Detailed description: 
      Although the usage of space maintainers can reduce the severity of problems that arise from
      the early loss of teeth, there are concerns regarding the impact of fixed and removable
      appliances on factors that can lead to dental caries. All space maintainer appliances are
      plaque retentive since bands and brackets increase the retention of plaque and food on tooth
      surfaces, reduce the clearance of plaque by saliva and make conventional oral hygiene for
      plaque removal more difficult, therefore, they may cause caries development.Space maintainers
      can favor caries formation by changing the oral microflora. patients aged between 4-10 years,
      each of whom had an indication for a fixed (n=19) or removable space maintainer (n=19), were
      enrolled in this research. The salivary pH, saliva flow rate, Streptococcus mutans and
      Lactobacillus counts in saliva were measured just prior to the application of space
      maintainers (baseline-T0) and in the course of the follow-up; at the 1st (T1), 3rd (T2), and
      6th (T3) months. The Wilcoxon, Mann-Whithney U test and Friedman tests were used for
      statistical analyses.
    

Intervention name(s): The Salivary pH measured; The saliva flow rate was measured; Streptococcus mutans and Lactobacillus counts in saliva were measured
Intervention type(s): Other; Other; Other
Intervention description(s): The saliva samples were obtained at 10-12 a.m. from all children. The saliva was collected into plastic cylinders and the salivary pH was measured with a pH meter (Compact pH meter B-212 twin pH, HORIBA, Osaka, Japan).; The saliva flow rate was estimated by during the first 30 s of paraffin chewing. The saliva was collected into plastic cylinders for a period of 5 minutes. Afterward, the saliva were weighed with a in a precision balance (Mettler PC 400, Zurich, Switzerland) and the flow rate was computed in gms/ml.; The saliva samples were obtained according to described above. Numbers of colony-forming units (CFU) of S. mutans were counted on TSY20B agar and Lactobacilli were counted on Rogosa agar.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Space maintainers; Streptococcus mutans; Lactobacillus; Salivary flow; Salivary pH