bioihbjkbjnl/mcl2 huggingface dataset:
Impact Of Physiotherapy And Botox In Improving Functional Outcomes Among Post Stroke Focal Dystonia Patients
Condition: Focal Hand Dystonia
MeSH terms: Dystonia; Dystonic Disorders
Study type: Interventional

Summary: 
      This study was conducted to assess the combine role of Physiotherapy by providing task
      specific trainings and Botulinum Toxin Type A in improving the functional outcomes of upper
      limb in post stroke patients with focal hand dystonia.
    

Detailed description: 
      Post-stroke hemiparesis, with dystonia, is a major cause of disability. Dystonia can hinder
      the functional activities making patient dependent on others for performance of daily living
      activities. Dystonia not only limits the physical activity of the patient but also affects
      their quality of life significantly. Various treatment protocols have been used in the
      literature for treatment of focal hand dystonia in the past including deep brain stimulation,
      kinesio taping, sensory oriented training, splinting, extracorporeal shock wave therapy and
      botox. Out of these Botox has gained much importance but it results only in improving the
      passive range of motion and has no consensus in improving the active range of motion and
      functional independence of the patient. The current study was planned to determine the
      effects of botulinum toxin type A combined with task-specific therapy, for post-stroke focal
      dystonia of upper limb.
    

Intervention name(s): Botulinum toxin type A; Task Specific Training
Intervention type(s): Other; Other
Intervention description(s): All patients in the experimental group received a BoNT-A injection. The injected total dose for individual patient in the experimental group was 100 units which is equivalent to approximately 300-500 Units of Dysport (the other type of BoNT-A available). The Botox was injected by the neurophysician intramuscularly using insulin U100 syringe and determination of muscles for injection was assessed clinically.; Task specific training is the repetition of a specific task until expertise is reached. More challenging tasks are added as a means of progression
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A total of 46 patients were recruited in the study using non-probability purposive sampling and were divided randomly into two equal groups; control and experimental group, by sealed envelope method. The experimental group received botulinum toxin A followed by task specific training, while the control group received only task-specific training for 12 weeks. Data was collected at baseline, after 4 weeks, 8 weeks and 12 weeks by using upper extremity items of Motor Assessment Scale and Fugl Meyer Assessment scale of upper limb, Stroke specific quality of Life, Arm dystonia Disability scale and WOLF Motor function test.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dystonia Task-specific training Botulinum toxin type A
Minimally Invasive Non Surgical Therapy Versus Conventional Scaling and Root Planing for Treatment of Periodontitis
Condition: Periodontal Diseases
MeSH terms: Periodontitis; Periodontal Diseases
Study type: Interventional

Summary: 
      Minimally invasive non-surgical therapy (MINST) is a new approach towards regeneration of
      deep periodontal defects. Important part of MINST procedure, besides usage of magnification
      loupes and piezo-electric devices seems to be the usage of special mini-curettes, originally
      mini-five and after mini-five of Hu-Friedy. So far only descriptive data about the clinical
      effects of such procedure are available and comparative studies that would include other
      treatment alternatives are lacking. Therefore, the aim of our study is, on split-mouth model,
      to compare the number of diseased sites (defined by probing depth ˃ 4 mm and bleeding on
      probing) after conventional non-surgical therapy and MINST with the usage of special
      mini-curettes. In addition, new 3D parameters obtained from 3D optical scanning will be
      developed for evaluation of volume changes of soft tissues.
    


Intervention name(s): MINST; Conventional SRP
Intervention type(s): Procedure; Procedure
Intervention description(s): For reducing the need of surgical treatment in patients with chronic periodontal disease, we will use specifically designed Hu-Friedy curettes "mini five", "micro mini five" and "after five" together with piezoelectric device with thin and delicate tips that produce less periodontal trauma than usual Gracey curettes.; Scaling and root planing with conventional instruments.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Split mouth - experimental and control side in the same individual Side selection will be randomized
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Periodontitis; MINST; Scaling and root planing; Split mouth; 3D analysis
Does Moderate Physical Activity in Hemodialysis Patients Reduce Inflammation?
Condition: End-stage Renal Disease; Hemodialysis
MeSH terms: Kidney Failure, Chronic; Inflammation
Study type: Observational

Summary: 
      The purpose of this study is to observe a potential benefit of moderate physical activity by
      using bed mounted cycles during hemodialysis treatment sessions on inflammatory markers in
      the blood of patients with end-stage renal disease (ESRD).
    

Detailed description: 
      Patients with ESRD on chronic hemodialysis patients frequently have elevated markers of
      inflammation (e.g., serum CRP values) and accumulation of proinflammatory monocyte
      populations in the circulation. The level of inflammation is highly predictive for
      cardiovascular disease and mortality. Physical activity has been shown to improve dialysis
      efficacy by improving the elimination of retention solutes. In healthy individuals, sports
      activity influences inflammatory immune parameters. The study will observe the influence of
      moderate physical activity (using a bed mounted cycle for 30min during dialysis thrice
      weekly) on circulating monocyte subpopulations and inflammatory proteins over a 9 month
      period in 16 chronic hemodialysis patients.
    

Intervention name(s): moderate physical activity
Intervention type(s): Behavioral
Intervention description(s): bed mounted cycles for physical activity for 30 min during each hemodialysis session
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        End-stage renal disease patients on chronic hemodialysis therapy
      
Biospecimen description: 
      Serum and DNA samples
    
Keywords: inflammation; cardiovascular disease
Repetitive Transcranial Magnetic Stimulation as a Potential Tool to Reduce Sexual Arousal
Condition: Transcranial Magnetic Stimulation
Study type: Interventional

Summary: 
      Hyper- and hyposexuality occur frequently in a variety of psychiatric disorders and are
      difficult to treat. While there is meta-analytic evidence for the significant effect of
      non-invasive brain stimulation on drug and food craving, no study has investigated the
      potential of this technique to modulate sexual behavior. The efficacy of a single session of
      high-frequency repetitive transcranial magnetic stimulation (rTMS) over the left or right
      dorsolateral prefrontal cortex (DLPFC) to reduce sexual arousal was tested against a sham
      stimulation.

      To test this hypothesis, we employed a randomized, double-blind, sham-controlled crossover
      study design. Nineteen healthy male participants received high-frequency rTMS over the left
      DLPFC, high-frequency rTMS over the right DLPFC and sham rTMS (each 10 Hz; 110% resting motor
      threshold; 60 trains with 50 pulses) in randomized and counterbalanced order with a one-week
      interval between stimulation sessions to avoid carryover effects. Participants were exposed
      to neutral and sexual cues before and after each intervention and rated their sexual arousal
      after each block of cue presentation.
    


Intervention name(s): repetitive transcranial magnetic stimulation
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: sexual arousal
Open Versus Laparoscopically-assisted Esophagectomy for Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional

Summary: 
      To compare laparoscopically-assisted gastric mobilization versus open gastric mobilization in
      Ivor-Lewis esophagectomy for esophageal cancer, with open thoracic approach in the 2 arms.
    

Detailed description: 
      Open Versus Laparoscopically-assisted Esophagectomy for Cancer
    

Intervention name(s): Laparoscopically-assisted esophagectomy
Intervention type(s): Procedure
Intervention description(s): To compare during the abdominal approach the laparoscopic route to the open route for gastric mobilization. Thoracic approach will be the same between the 2 arms through thoracotomy with extended two field lymphadenectomy
Other intervention name(s): esophagectomy with extended two-field lymphadenectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Esophagus; Cancer; Surgery; Laparoscopy; Randomized trial; Esophageal cancer deemed to be resectable
Comparative Glucose Clamp Study of Wockhardt's Insulin Human Regular for Injection and Actrapid, in Type 1 Diabetics
Condition: Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this trial is to demonstrate bioequivalence of Wosulin R to Actrapid with regard
      to its total and to its maximum serum insulin concentrations.
    

Detailed description: 
      The purpose of this study is to test for bioequivalence based on the pharmacokinetic
      parameters Cmax and AUC0-12h between two recombinant soluble human insulin preparations. The
      study also compares the other pharmacokinetic parameters and pharmacodynamic profiles as well
      as assesses safety and local tolerability of the two insulin preparations in type 1
      diabetics.
    

Intervention name(s): Wosulin R; Actrapid
Intervention type(s): Biological; Biological
Intervention description(s): Total dose per subject will be 0.3 IU/Kg given Subcutaneously.; Total dose per subject will be 0.3 IU/kg given Subcutaneously.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: pharmacokinetics; pharmacodynamics; type 1 diabetics; recombinant human insulin
Avanz Phleum Pratense Maintenance Dose
Condition: Allergic Rhinoconjunctivitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of the trial is to evaluate the efficacy of two dosing schedules of Avanz SQ+
      (Standardised Quality) Phleum pratense compared to placebo in subjects with grass pollen
      induced allergic rhinoconjunctivitis with or without asthma.
    


Intervention name(s): Avanz Phleum pratense; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Suspension for Injection, Every 6 weeks for one year; Suspension for Injection, Every 6 weeks for one year
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
FreeStyle Libre Glucose Monitoring System Paediatric Study
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The study is designed to determine glycaemic control achieved using the FreeStyle Libre Flash
      Glucose Monitoring System (FreeStyle Libre) versus Self-Monitoring Blood Glucose (SMBG) for
      the self-management of diabetes.
    


Intervention name(s): FreeStyle Libre Flash Glucose Monitoring System
Intervention type(s): Device
Intervention description(s): Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System masked for 14 days followed by 8 weeks unmasked wear.
During the 2 weeks of masked device wear participants will use the BG strip port for self-monitoring of blood glucose (SMBG). Scanning the sensor at least every 8 hours during this phase.
Followed by 8 weeks of unmasked device wear when participants will use the device (Sensor glucose and SMBG) according to labelling for their day to day management.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Diabetes Mellitus, Paediatric; Sensing Technology
Preoperative Relaxation Training and Acupuncture to Minimize Perioperative Symptoms in Breast Cancer Patients
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Breast cancer surgery is associated with presurgical psychological distress and clinically
      significant side effects including postsurgical pain, nausea and fatigue. A few studies have
      examined how to intervene to assist women undergoing breast cancer surgery. For example
      presurgical hypnosis has been proven to decrease side effects and even intraoperative
      anesthesia use. Besides the more psychologically based interventions there are a few studies
      suggesting positive effects of acupuncture on pain, anxiety and nausea in surgery
      patients.This study aims to investigate whether a presurgical relaxation training,
      acupuncture treatment or a combination of both therapies is able to reduce presurgical
      psychological distress an postsurgical side effects in breast cancer patients in comparison
      to usual care.
    


Intervention name(s): relaxation training; acupuncture
Intervention type(s): Behavioral; Other
Intervention description(s): The relaxation sessions comprise an introduction in 3 relaxation techniques conducted by a mind-body therapist: "Body Scan", mindfulness meditation and imagination. Patients also receive a CD with different relaxation exercises and the instruction to exercise daily at home for at least 15 minutes.; The acupuncture treatment comprises needling of 6 standardized acupoints: Pericardium 6, Stomach 36, Large intestine 4, Spleen/Pancreas 10, Dumai 20, Liver 3, Shenmen. Additional points can be chosen individual.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study of IBI310 for the Treatment of Patients With Advanced Solid Tumors.
Condition: Advanced Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability,
      pharmacokinetics, pharmacodynamics, immunogenicity and efficacy of single agent of IBI310,
      and in combination of sintilimab, in patients with advanced solid tumors(Ia) and advanced
      melanoma(Ib).
    

Detailed description: 
      Phase Ia study will adopt the classical 3+3 dose escalation design. The starting dose is 0.3
      mg/kg, followed by 3 dose cohorts (1mg/kg, 2mg/kg and 3mg/kg). Duration of dose limiting
      toxicity (DLT) observation period is 21 days. IBI310 treatment q3w, up to 3 cycles, will be
      provided to patients who complete DLT observation period.

      Efficacy will primarily be evaluated by RECIST v1.1. Patient safety will be monitored
      throughout the study. Pharmacokinetic/pharmacodynamics and immunogenicity will be assessed
      throughout the study.

      Phase Ib study will evaluate the tolerability and safety of IBI310 combined with Sintilimab
      in patients with advanced melanoma. Phase Ib of the study will begin after DLT observation is
      completed in certain dose cohorts.
    

Intervention name(s): IBI310; Sintilimab
Intervention type(s): Drug; Drug
Intervention description(s): IBI310 is anti CTLA-4 antibody; PD-1 monoclonal antibody
Other intervention name(s): CTLA-4
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial of Ciclesonide in Adults With Mild-to-moderate COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      According to In vitro studies, ciclesonide showed good antiviral activity against severe
      acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Although some cases were reported for
      the clinical effectiveness of ciclesonide in the treatment of COVID-19, there is no clinical
      trial to evaluate the antiviral effect on the reduction of viral load in patients with
      COVID-19. In this study, we aimed to investigate whether ciclesonide inhalation could
      eradicate SARS-CoV-2 compared to standard supportive care in patients with mild COVID-19.
    


Intervention name(s): Ciclesonide Metered Dose Inhaler [Alvesco]
Intervention type(s): Drug
Intervention description(s): Ciclesonide 320ug oral inhalation q12h for 14 days
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This multicenter study is an open-labelled, randomized clinical trial for 1:1 ratio of ciclesonide or control arm (standard care)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SARS-CoV-2; Ciclesonide; Viral load; Coronavirus
Laparoscopic Incisional Hernia Repair in Liver Transplant Patients
Condition: Hernia Recurrence Post Laparoscopic Incisional Hernia Repair in Liver Transplant Versus Non-transplant Patients.
MeSH terms: Hernia; Recurrence; Incisional Hernia
Study type: Observational

Summary: 
      Retrospective analysis of patients undergoing laparoscopic incisional hernia repair.

      Study group: Patients with incisional hernia post liver transplantation Control group:
      Patients with incisional hernia post any other laparotomy in the upper quadrant.

      Primary study outcome parameter: Risk of hernia recurrence. Secondary study outcome
      parameters: - Hernia repair-related infection rate

      - Postoperative morbidity Statistical analysis: Comparison of study versus control group,
      univariate and multivariate analysis, Chi² and Mann-Whitney-U tests. P-values <0.05 were
      considered significant.
    


Intervention name(s): Surgery
Intervention type(s): Other
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patient with incisional hernia post liver transplantation
Nutraceutical Supplement in the Management of Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of a proprietary
      nutraceutical supplement in capsule form over 4 months in treating blood pressure in a group
      of chronic hypertensive subjects that are not receiving any pharmaceutical anti-hypertensive
      agents or other nutraceutical supplements.
    


Intervention name(s): Cardiopressin; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Effectiveness of an Intensive Intervention to Improve Physical Activity in Postmenopausal and Sedentary Women
Condition: Healthy
Study type: Interventional

Summary: 
      This is a randomized clinical trial aimed at postmenopausal women aged 45 to 70 years old
      selected in urban primary care centers of two centers (Spain). Its objective is to evaluate
      the effects of an intensive intervention in the increase of physical activity and the
      decrease of sedentary lifestyle in postmenopausal and sedentary women.
    

Detailed description: 
      Objective: to evaluate the effects at 6 months of an intensive intervention in the increase
      of physical activity and the decrease of sedentary lifestyle in postmenopausal and sedentary
      women.

      Design and setting: A randomized clinical trial of two parallel groups. Population: 100
      postmenopausal women, 45 to 70 aged will be included, selected by consecutive sampling in two
      primary care centers.

      Measurements and intervention: Physical activity, body composition, BMI and health-related
      quality of life will be evaluated. The intervention group will receive an intensive program
      of combined exercise for 6 months and use during this period a Smartband, in order to
      encourage and increase physical activity and decrease sedentary lifestyle
    

Intervention name(s): Control; Intervention group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Counseling on physical activity; Program of combined exercise and a Smartband for 6 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Physical activity; Postmenopause; Body composition; Health education; Information and Communication Technologies
Extension Study of MT-1303 in Subjects With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives of the study are:

      -To evaluate the long-term safety and tolerability of MT-1303 in subjects with moderate to
      severe active Crohn's Disease（CD）
    


Intervention name(s): MT-1303
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crohn's Disease