bioihbjkbjnl/mcl2 huggingface dataset:
Shortwave Diathermy and Pilates Exercises in Patients With Chronic Non-specific Low Back
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain; Hyperthermia
Study type: Interventional

Summary: 
      The aim of this study is to verify the effectiveness of the association of Shortwave
      Diathermy and Pilates exercises in patients with chronic non-specific low back pain, on the
      reduction of pain, functional disability and improvement of the quality of life.
    

Detailed description: 
      The drawing of the study will be a prospective, randomized controlled trial and double-blind
      with quantitative approach. Study participants 36 subjects diagnosed with non-specific
      chronic low back pain, which will be divided in two groups with 18 subjects in each:
      experimental group, which will be submitted to placebo + exercise shortwave diathermy and the
      control group to do active + exercise shortwave diathermy. There will be 12 one-hour sessions
      twice a week. The subjects will apply Shortwave Diathermy for 20 minutes, followed by Pilates
      mat.
    

Intervention name(s): Pilates and Shortwave placebo; Pilates and Shortwave active
Intervention type(s): Device; Device
Intervention description(s): Pilates exercises and application of the device without produce thermal effects; Pilates exercises and application of the device producing thermal effects
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise Therapy; Clinical Trial; Diathermy; Physical Therapy Modalities
Antibody Persistence, Immune Response and Safety After Doses of Pentabio Vaccine
Condition: Healthy
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Measure antibody persistence prior to booster administration of Pentabio vaccine.
    

Detailed description: 
      Number and percentage of children with anti diphtheria, titer and anti tetanus titer >= 0.01
      IU/ml, anti HBs >=10mIU/ml, anti Hib >=0.15ug/ml prior to booster administration.
    

Intervention name(s): Pentavalen
Intervention type(s): Biological
Intervention description(s): Batch 5010613
Other intervention name(s): Pentabio vaccine; DPT-HB-Hib
Intervention MeSH terms: Vaccines
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: DTP-HB-Hib; Pentavalen; Pentabio; Booster
Combination of Telmisartan 40 mg Plus Hydrochlorothiazide (HCTZ) 12.5 mg vs. Telmisartan 40 mg Alone in Patients With Essential Hypertension Who Fail to Respond Adequately to Telmisartan Monotherapy
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this trial is to demonstrate that the fixed dose combination of telmisartan
      40 mg and HCTZ 12.5 mg is superior to the monocomponent of telmisartan (Micardis, Gliosartan,
      Kinzal, Kinzalmono, Predxal, Pritor, Samertan, Telmisartan) 40 mg in patients with essential
      hypertension who fail to respond adequately to telmisartan monotherapy.
    

Detailed description: 
      This is a multi-centre, randomised, double-blind, double-dummy, active-controlled,
      parallel-group study in patients with essential hypertension who fail to respond adequately
      to telmisartan (Micardis) 40 mg monotherapy.

      After a screening and a 2-week washout period (screening period), the patients will enter
      4-week open-label run-in period with telmisartan (Micardis) 40 mg monotherapy to assess
      eligibility. The study will be terminated for those who have responded to telmisartan
      (Micardis) 40 mg monotherapy at the end of 4-week open-label run-in period with telmisartan
      (Micardis) 40 mg monotherapy (mean seated DBP < 90 mmHg). About 200 patients not responding
      adequately to telmisartan (Micardis) 40 mg monotherapy will be randomised and treated for 8
      weeks with once-daily administration of either telmisartan (Micardis) 40 mg or a fixed dose
      combination of telmisartan 40 mg and HCTZ 12.5 mg (double-blind treatment period).

      Study Hypothesis:

      The hypothesis is that the fixed dose combination of telmisartan 40 mg and HCTZ 12.5 mg is
      superior to the monocomponent of telmisartan (Micardis) 40 mg in pat ient with essential
      hypertension who fail to respond adequately to telmisartan monotherapy.

      Comparison(s):

      For the primary comparison the change from baseline in mean stated trough DBP at the end of
      the 8-week double-blind treatment will be expressed.
    

Intervention name(s): Telmisartan 40 mg/HCTZ 12.5 mg; Telmisartan 40 mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Telmisartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Expectation and Response to Levodopa and Acupuncture in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      To investigate how levodopa and acupuncture affect fatigue and muscle function in people who
      suffer from Parkinson's disease. Subjects may choose to participate in levodopa or
      acupuncture part, or both. Study procedures include an exercise protocol, transcranial
      magnetic stimulation (a non-invasive type of brain stimulation that cause small muscle
      twitch), a blood draw, and personality surveys.
    

Detailed description: 
      Subjects will answer surveys, have their blood drawn, undergo TMS and perform an exercise.
      The TMS/exercise task will measure fatigue and muscle response. The surveys will describe
      personality and measure fatigue. The CTRC will do genotype studies on the blood to look for
      genetic differences. Each subject is eligible to receive both study treatment types (levodopa
      and acupuncture). Depending upon the study treatment type they choose, each subject will be
      randomly assigned to one of six possible subject groups:

      Ia. Full expectancy; levodopa: Subjects will be told that they are taking levodopa.

      Ib. Half expectancy; levodopa: Subjects will be told that they have 50% chance of receiving
      levodopa or placebo.

      Ic. No expectancy; levodopa: Subjects will be told that they are receiving placebo levodopa.

      IIa. Full expectancy; acupuncture: Subjects will be told that they are receiving real
      acupuncture.

      IIb. Half expectancy; acupuncture: Subjects will be told that they have 50% chance of
      receiving real or sham-acupuncture.

      IIc. No expectancy; acupuncture: Subjects will be told that they are receiving
      sham-acupuncture.

      Subjects will attend four visits for the levodopa part and/or three visits in the acupuncture
      part. On the first visit, subjects will answer questionnaires and have samples of their blood
      collected. On the other visits, subjects will undergo TMS while they perform a repetitive
      exercise task. Subjects will then either wait for 30 minutes or receive the investigative
      intervention that they have been randomly assigned for that particular visit, and then repeat
      the TMS/exercise task.
    

Intervention name(s): Levodopa or acupuncture
Intervention type(s): Behavioral
Intervention description(s): Comparison of subject expectancy of receiving levodopa or acupuncture.
Intervention MeSH terms: Levodopa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: fatigue; TMS; MEP
Intensive Combo Chemo With Autologous BM Rescue for Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the therapeutic efficacy of high-dose cyclophosphamide and BCNU with autologous
      bone marrow transplantation after initial tumor cytoreduction for patients with
      receptor-negative metastatic breast carcinoma and to determine the optimal timing of
      CyBCNU-ABMT after initial development of metastatic breast carcinoma
    


Intervention name(s): High-dose chemotherapy
Intervention type(s): Procedure
Intervention description(s): Cyclophosphamide 500 mg/m2 IV day 1; Doxorubicin 30 mg/m2 IV Day 1; Methotrexate 300 mg/m2 IV Day 8;5-FU 500 mg/m2 IV day 8; leucovorin 20 mg po q 6 h x 6 doses, day 9- cycles repeated q 21 days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioimpedance Spectroscopy for the Differential Diagnosis of Hyponatremia
Condition: Hyponatremia
MeSH terms: Hyponatremia
Study type: Observational [Patient Registry]

Summary: 
      We aimed to investigate the role of bioimpedance spectroscopy for the diagnosis of
      hyponatremia
    

Detailed description: 
      -  Up to now, "Hyponatremia" differentially diagnosed by physical examination, plasma and
           urine osmolalities, Echocardiography and biochemical measurements.

        -  The purpose of this study is to determine whether bioimpedance spectroscopy can be used
           for the detection of hypovolemia and hypervolemia for the differential diagnosis of
           hyponatremia.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients admitted to Bulent Ecevit University Hospital with the presentation of
        hyponatremia
      
Keywords: Bioimpedance spectroscopy; Hypervolemia; Hypovolemia
Pilot Study With GFT505 (80mg) in Patients Presenting With Impaired Glucose Tolerance and Abdominal Obesity.
Condition: Impaired Glucose Tolerance; Abdominal Obesity
MeSH terms: Obesity; Glucose Intolerance; Obesity, Abdominal
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of GFT505 80mg compared with placebo in
      improving Oral Glucose Tolerance Test (OGTT), in patients with impaired glucose tolerance and
      abdominal obesity, and to assess the tolerability and safety of once-a-day administrations of
      oral doses of GFT505 during 35 days.
    

Detailed description: 
      The study period is 13 weeks maximum per patient : A screening period (1 to 6-weeks) will
      precede a 5-week double-blind treatment period and a 2-week follow-up period. The duration of
      the screening period will depend on the necessity to introduce a wash-out for lipid-lowering
      drugs : 4-week wash-out from statins and other lipid regulating drugs and 6-week wash-out
      from fibrates. During the screening period, patients will be asked to start or continue
      adequate diet and exercise.
    

Intervention name(s): GFT505 80mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast.; Hard gelatin capsules, oral administration, 4 capsules per day before breakfast.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Impaired Glucose tolerance; OGTT; PPARs
Efficacy and Safety of Poly-L-lactic Acid
Condition: Buttock Contouring; Buttock Lifting
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a phase IV prospective, multicentre, single cohort, open-label clinical trial
      evaluating the efficacy and safety of Poly-L-lactic acid (Sculptra® Aesthetic) for the
      treatment of contour deformities of the buttocks region
    


Intervention name(s): Poly-L-lactic acid (Sculptra® Aesthetic)
Intervention type(s): Device
Intervention description(s): Sculptra® Aesthetic is a commercially available product that is licensed for sale in Canada. It is an injectable implant that contains microparticles of poly-L-lactic acid (PLLA), a biocompatible, biodegradable, synthetic polymer from the alpha-hydroxy-acid family. Sculptra® Aesthetic is suitable for increasing the volume of depressed areas, particularly to correct skin depressions, such as in skin creases, wrinkles, folds, scars and for skin aging. Sculptra® Aesthetic is also suitable for large volume corrections of the signs of facial fat loss (lipoatrophy).
The safety and efficacy of Sculptra® Aesthetic has been investigated in the literature and is generally considered safe and effective. PLLA has been used successfully to reverse HIV-associated lipoatrophy as well as to rejuvenate the face, neck, décolletage, hands, abdomen and gluteal regions.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Examine the Effect of Daridorexant on the Way the Body Absorbs, Distributes, and Gets Rid of Midazolam and Warfarin in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to examine the effect of daridorexant on the way the body absorbs, distributes, and
      gets rid of midazolam and warfarin in healthy male subjects
    


Intervention name(s): Midazolam; Warfarin; Daridorexant
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will receive a single oral dose of 2 mg midazolam (Treatment A, B, and C).; Subjects will receive a single oral dose of 25 mg warfarin (Treatment A and B).; Subjects will receive an o.d. oral dose of 50 mg daridorexant from Day 1 to Day 7 of Treatment B and a single oral dose of 50 mg daridorexant on Day 1 of Treatment C.
Intervention MeSH terms: Midazolam; Warfarin
Intervention model: Sequential Assignment
Intervention model description: This is a prospective, open-label, fixed-sequence Phase 1 study.
Masking: None (Open Label)
Primary purpose: Other
Impact of COVID-19 Pandemic on Early Spontaneous Abortions and Early Termination of Pregnancy
Condition: Termination of Pregnancy; Covid19; Pregnancy Loss
MeSH terms: COVID-19; Abortion, Spontaneous
Study type: Observational

Summary: 
      To see the impact the COVID-19 pandemic has had on early spontaneous abortions and early
      termination of pregnancy in the first trimester
    

Detailed description: 
      To date, the research has focused on the complications of SARS-CoV-2 in pregnant women. There
      is no research in the literature that has compared the rates and behavior of miscarriage
      during the time of the COVID-19 pandemic to before the time of the pandemic. As described in
      the literature, there is an established connection between COVID-19 and stress, anxiety, and
      depression. There is also an established connection between stress, anxiety, and depression
      and rates of miscarriage. The investigators hereby wish to analyze the effect of the COVID-19
      pandemic on miscarriages.

      In this study, The investigators will analyze the number of early missed abortions and number
      of termination of pregnancies in the first trimester before and during the COVID-19 pandemic.
      The investigators will also analyze the time interval between diagnosis of missed abortion
      and attendance to E.R in missed abortions during the COVID-19 pandemic. In addition, The
      investigators will be comparing the reasons for termination of pregnancy during this time, as
      well as analyzing age, religion, and demographic variables during the COVID-19 pandemic
      compared to years prior.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All women attending for early missed abortion or termination of pregnancy receiving
        treatment between March 11th - November 30th during the years 2017-2020 Gestational age
        until 12 weeks 6 days (1st trimester only)
Laparoscopic Surgery of Rectal Cancer and Ileostomy
Condition: Ileostomy - Stoma; Ileostomy; Complications; Leakage, Anastomotic
MeSH terms: Anastomotic Leak
Study type: Observational

Summary: 
      Elective diverting ileostomy may reduce consequences of anastomotic failure in laparoscopic
      TME. Aiming to evaluate the effectiveness of elective diverting ileostomy, its impact on the
      incidence and clinical behavior of anastomotic leakage and the complications related to its
      presence and take down were analyzed.
    

Detailed description: 
      From a prospective collected database, data regarding patients who underwent to laparoscopic
      TME, with (Group 1) or without (Group 2) elective diverting ileostomy for rectal cancer from
      2012 to 2017 at University Campus Bio-Medico di Roma, have been retrospectively analyzed.
    

Intervention name(s): elective diverting ileostomy
Intervention type(s): Procedure
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who underwent to laparoscopic TME, for rectal cancer from 2012 to 2017 at
        University Campus Bio-Medico di Roma.
Chasing Biomarkers in Post-concussion Syndrome
Condition: Post Concussive Symptoms
MeSH terms: Post-Concussion Syndrome
Study type: Interventional

Summary: 
      The goal of this study was to investigate the biomarkers, neurofilament light chain,
      inflammatory markers, calcitonin-gene-related peptide, and metabolites from the kynurenine
      pathway in patients with severe post-concussive symptoms. The main question it aimed to
      answer was:

        -  Are the biomarker concentrations significantly changed in patients with severe
           post-concussive symptoms compared to healthy individuals?

        -  Do the biomarker concentrations change at follow-up?

      Participants were recruited from a recently published randomized controlled trial
      (Clinicaltrials.gov no. NCT02337101 / PMID: 31891145 ). The biomarker concentrations were
      compared to a healthy control group recruited from the Blood Bank at Aarhus University
      Hospital in 2022.
    

Detailed description: 
      In the previously published RCT-study (PMID: 31891145), 86 participants with severe
      post-concussive symptoms provided blood samples at baseline (4 months after the concussion).
      Severe post-concussive symptoms were defined as having a Rivermead Post Concussion
      Questionnaire >20.

      Around 7 months later, a follow-up blood sample was obtained from 54 participants.

      These blood samples were used to investigate blood biomarkers for the condition.
    

Intervention name(s): Early intervention programme; Enhanced usual care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): For more information, please go to the original registration of the RCT-study (NCT02337101) or the published article (PMID: 31891145).; For more information, please go to the original registration of the RCT-study (NCT02337101) or the published article (PMID: 31891145).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Health Promotion in Adolescents in Ecuador
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Worldwide, low-income and middle-income countries are undergoing rapid demographic and
      nutritional changes. Populations tend to move from their traditional food habits towards
      dietary patterns characterized by a more energy-dense diet, while urbanization and technology
      (work, transport) play a role in the reduction of their physical activity. This shift towards
      energy-dense diets and lower levels of physical activity are key determinants of chronic
      diseases. Nowadays, childhood overweight and obesity are becoming a major threat to public
      health all in low-income and middle-income countries. Clearly, not properly addressing this
      health problem will only aggravate the already enormous impact of chronic diseases on the
      social and economic development of these countries. This study aims to develop a culturally
      relevant school-based prevention intervention among Ecuadorian adolescents (11-13 years old)
      in Cuenca. The intervention will target behavioural nutrition and physical activity.
      Intervention strategies will be developed based on theoretical behavioural change models
      integrated in two complementary frameworks, i.e. (i) the Intervention Mapping protocol, and
      (ii) the Comprehensive Participatory Planning and Evaluation protocol.

      The study includes two phases:

        1. A formative research, which will be conducted in order to understand the causality of
           the school environment and unhealthy eating and low physical activity levels in
           school-going adolescents, aged 12-13 years old.

        2. A paired, cluster-randomized controlled trial including 1400 adolescents (12-13 years
           old) from 10 pairs of schools (i.e. clusters). Within each pair of clusters, one cluster
           will be randomly assigned to the intervention and the other to the control group.
    


Intervention name(s): Experimental
Intervention type(s): Other
Intervention description(s): Environmental- and individual based components carried out in the school.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Promoting healthy lifestyles in adolescents in Ecuador to prevent overweight
A Study to Evaluate the Safety of Administering Ocrelizumab Per a Shorter Infusion Protocol in Participants With Primary Progressive Multiple Sclerosis (PPMS) and Relapsing Multiple Sclerosis (RMS)
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is an open-label, non-randomized study to evaluate rate and severity of
      infusion-related reactions (IRRs) of ocrelizumab infused over a shorter time period than the
      approved administration rate in participants with PPMS or RMS in the United States (U.S.).
      Participants will be enrolled into two cohorts. Cohort 1 will examine the effect of
      administering ocrelizumab per a shorter infusion protocol for Dose 2 or Dose 3. This cohort
      will consist of patients who have already received one or two doses of ocrelizumab according
      to the approved infusion protocol (i.e., per the currently U.S. label) and have reported no
      serious IRRs and who will then receive the next infusion of ocrelizumab at a higher rate in
      order to deliver 600 mg over the course of approximately 2 hours. Cohort 2 will examine the
      effect of administering ocrelizumab per a shorter infusion protocol for the second infusion
      of Dose 1. This cohort will consist of ocrelizumab naïve patients who, after receiving
      Infusion 1/Dose 1 of ocrelizumab at the approved rate (300 mg over approximately 2.5 hours or
      longer) have no reported serious IRRs, will then receive the second 300-mg shorter infusion
      over approximately 1.5 hours.
    


Intervention name(s): Ocrelizumab Dose 1; Ocrelizumab Dose 2 and Dose 3
Intervention type(s): Drug; Drug
Intervention description(s): 300 mg infusion administered to ocrelizumab-naive participants per approved protocol (over approximately 2.5 hours or longer) as per standard of care followed by a second 300 mg shorter infusion over approximately 1.5 hours.; 600 mg infusion of ocrelizumab administered at a shorter rate (i.e. over the course of approximately 2 hours) at Week 24 and at Week 48
Intervention MeSH terms: Ocrelizumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment