bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Bilateral TENS With TOT on Upper Limb Function in Patients With Chronic Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      On the basis that the combined use of Uni-TENS and TRT is an effective intervention in upper
      limb recovery, and the advantage of Bi-TENS eliciting extra neural pathway in the intact
      hemisphere to facilitate the motor recovery, There is a research gap in whether the Bi-TENS
      over both the paretic and non-paretic limbs could probably augment the treatment effects of
      TOT in upper limb motor control in people with stroke.
    

Detailed description: 
      The purpose of this study is to determine whether Bi-TENS+TOT was superior to Uni-TENS+TOT,
      Placebo-TENS+TOT alone and no active treatment in improving the upper limb motor control and
      upper limb function and community integration in people with chronic stroke.

      The null hypothesis will be that Bi-TENS+TOT is not significantly different from
      Uni-TENS+TOT,Placebo-TENS+TOT alone and no active treatment in improving the upper limb motor
      control and upper limb function and community integration in people with chronic stroke.
    

Intervention name(s): Task-orientated training; Transcutaneous electrical nerve stimulation (TENS); Sham electrical nerve stimulation
Intervention type(s): Behavioral; Device; Device
Intervention description(s): Task-Oriented Training (TOT) is a goal-directed exercise therapy, which help the people derive optimal control strategies for solving specific motor problems in real environment. In this study, TOT included stretching exercises, mobilizing exercise, strengthening exercises, seated reaching tasks, dexterity training and bimanual practice.; The stimulator was 120z Dual-Channel TENS Unit (ITO PHYSITHERAPY&REHABILITION CO., LTD, Tokyo, Japan). The parameter (100 Hz, 0.2 ms square pulses, intensity barely below the motor threshold) of TENS followed our previous study; A identical-looking TENS devices that electrical circuit has been disconnected.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: upper limb; transcutaneous electrical nerve stimulation
Immunogenicity, Safety, and Tolerability of MF59-Adjuvanted Versus Non-Adjuvanted Influenza Vaccines in Patients With HIV-1 Infection
Condition: H1N1 Influenza Virus; Human Immunodeficiency Virus Type 1 (HIV-1) Infection
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Influenza, Human; Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a phase III, randomized, controlled, open label study with two vaccine regimens. The
      study will assess the relative safety and immunogenicity of vaccine regimens comparing
      adjuvanted versus non-adjuvanted formulations of A(H1N1) inactivated influenza virus vaccine
      in subjects with Human Immunodeficiency Virus Type 1 (HIV-1) Infection and to compare safety
      and immunogenicity data with a contemporaneously enrolled control group of age-comparable,
      healthy subjects.

      Because certain individuals may be hypo-responsive to influenza vaccination, additional
      studies with high-risk groups are warranted in order to determine the optimal vaccine
      formulation and dosing schedule for prevention of novel H1N1 virus infection.
    


Intervention name(s): Focetria®; Begrivac®
Intervention type(s): Biological; Biological
Intervention description(s): 7.5 ug of HA antigen; adjuvanted; monovalent; 15 ug of HA antigen; non-adjuvanted; trivalent
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza A Virus; Virus Diseases; Influenza, Human; HIV-1; Immunodeficiency Virus; H1N1; HIV Infection; Immunogenicity; safety; tolerability
Evaluation of the American Thoracic Society Criteria for Predicting Multidrug-resistant Bacteria in Critically Ill Patients
Condition: Infection
MeSH terms: Infections
Study type: Observational

Summary: 
      Appropriate initial antibiotic treatment based on early diagnosis of etiology will improve
      the outcome of sepsis. The incidence rates of multidrug-resistant (MDR) bacteria, which are
      different between countries, will affect the accuracy of etiological diagnoses according to
      the American Thoracic Society (ATS) guidelines. Therefore the investigators determined the
      accuracy of the ATS criteria in predicting infection or colonization related to MDR bacteria
      in China.
    

Detailed description: 
      All data concerning patient characteristics at ICU admission and during ICU stay were
      prospectively collected.Screening for MDR bacteria (using nasal swabs, tracheal aspirates
      from intubated patients and specimens from the infection location) was performed at ICU
      admission and discharge. Risk factors for infection or colonization with MDR bacteria were
      recorded, and the accuracy of the ATS criteria in predicting infection or colonization with
      these bacteria at ICU admission was documented. All of the infected patients were treated by
      the attending physician, and the choice and adjustment of antibiotic were in accordance with
      the recommendations of the ATS guidelines.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Critically ill patients admitted to icu
      
Keywords: Colonization; infection; multidrug-resistant bacteria; guideline
Conventional Versus Rendezvous Technique of Intraoperative Endoscopic Retrograde Cholangiopancreatography
Condition: Common Bile Duct Gallstones
MeSH terms: Gallstones
Study type: Interventional

Summary: 
      One of the new methods for management of common bile duct stones is intraoperative endoscopic
      sphincterotomy. It can be performed by many techniques. In the study the investigators
      compare two methods to find out the best technique for intraoperative endoscopic
      sphincterotomy.
    


Intervention name(s): endoscopic sphincterotomy by conventional method; endoscopic sphincterotomy by rendezvous method
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Keywords: common bile duct stones
Written vs Electronic Safety Planning Study
Condition: Suicidal Ideation; Suicide Attempt; Mental Health
MeSH terms: Suicide; Suicidal Ideation; Suicide, Attempted
Study type: Interventional

Summary: 
      Safety planning is a brief, ED-feasible intervention which has been demonstrated to save
      lives and has been universally recommended by every recent expert consensus panel on suicide
      prevention strategies. In one popular version of the safety plan developed by Stanley et al,
      the patient is encouraged to write out the following items: identifying personal signs of a
      crisis; helpful internal coping strategies; social contacts or settings which may distract
      from a crisis; using family members or friends for help when in crisis; mental health
      professionals who can be contacted when in crisis; and restricting access to lethal means.

      This study aims to find out how valuable an electronic safety plan is compared to a
      traditional paper safety plan. People who are visiting the emergency department for thoughts
      of self-harm will be asked to participate.
    

Detailed description: 
      This project has 3 aims: (1) Will ED patients with suicidal ideation/attempt accept coaching
      on safety planning from non-clinical personnel (i.e., medical students or peer supporters);
      (2) Are these safety plans of high-enough quality for clinical personnel; and finally, (3)
      Will ED patients with suicidal ideation/attempt complete safety plans electronically?
    

Intervention name(s): Safety Net App
Intervention type(s): Other
Intervention description(s): The Safety Net app is an electronic version of a safety plan and it is available for download in Apple's App Store. A preview of the app is available at: https://apps.apple.com/us/app/stanley-brown-safety-plan/id695122998. This app is owned by Two Penguins Studios, LLC. It was developed in partnership with the New York State Office of Mental Health. Unlike the paper version, the Safety Net app allows participants to email a copy of their safety plan to whomever they wish. It also allows patients to dial 911 or the National Suicide Prevention Lifeline from the app.
Other intervention name(s): Stanley-Brown Safety Plan App
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Suicide; Suicide Prevention; Safety Planning; Safety Net App
Clinical Characteristics and Associations of the "Good Fontan" Patient
Condition: Congenital Heart Disease; Single-ventricle
MeSH terms: Heart Diseases; Heart Defects, Congenital; Univentricular Heart
Study type: Observational

Summary: 
      This study aims to determine what are some of the clinical characteristics and associations
      of Fontan patients who are doing well, as well as how accurate cardiology providers are at
      predicting the likelihood of future adverse event in their Fontan patients.
    

Detailed description: 
      This is a multi-center prospective study that involves collecting data from patients as well
      as their cardiology providers in order to determine whether there is correlation between
      patient-reported quality of life assessments and clinician-identified assessments of their
      patients. The study also involves collecting data from the medical records of participating
      patients and entering it into our study database.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with congenital heart disease who have undergone the Fontan procedure.
      
Keywords: Fontan; Single Ventricle
Action Observation in Knee Replacement
Condition: Total Knee Replacement
Study type: Interventional

Summary: 
      Postoperative rehabilitation is required for a successful outcome following total knee
      arthroplasty. Traditionally rehabilitative programs aim to increase range of motion, to
      strengthen quadriceps, to restore normal gait, and to recover independence in activities of
      daily living. In the last decade action observation treatment, in addition to conventional
      physiotherapy has been proposed as a treatment method in rehabilitative medicine. There is
      growing evidence of the applicability of action observation training in rehabilitative
      medicine, indeed it has been applied in the rehabilitation of stroke of Parkinson disease of
      cerebral palsy and of aphasia.

      Nevertheless those are small studies and one of them included a mixed population of hip and
      knee arthroplasty.
    


Intervention name(s): Experimental group; Control group; Conventional physiotherapy
Intervention type(s): Device; Device; Device
Intervention description(s): Video of the exercises; video of nature scenes; Mobilization, exercises and transfer practice.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Total knee replacement; Action observation treatment; Rehabilitation
AirXpanders AeroForm Tissue Expander System for Breast Reconstruction
Condition: Breast Cancer
Study type: Interventional

Summary: 
      This study is designed to allow existing investigators continued access to the AeroForm
      Tissue Expander to treat patients while AirXpanders completes a marketing application and
      during the review process by FDA.
    

Detailed description: 
      This is a prospective, multi-center, single arm, open-label, continued access clinical study.
      Subjects who meet the inclusion criteria and agree to participate in the study will be
      enrolled and implanted with the investigational AeroForm Tissue Expander. If the subject is
      having a bilateral procedure, the AeroForm expander will be implanted in each side. Subjects
      will be followed until the first post-operative visit after explant of the tissue expander(s)
      and exchange for permanent implant(s).
    

Intervention name(s): AeroForm Tissue Expander
Intervention type(s): Device
Intervention description(s): The AeroForm Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tissue Expansion; Tissue Expander; Breast Tissue Expansion; Breast Tissue Expander; Breast Reconstruction; 2 Stage Breast Reconstruction
Efficacy of Treatment for Obsessive Compulsive Disorder
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Observational

Summary: 
      The purpose of these questionnaires is to give us an overview of how OCD has affected your
      life and perhaps also to give us some clues about things that may have set you up to
      experience OCD.
    

Detailed description: 
      For us to evaluate the efficacy of our treatment programs, we are interested in your
      responses before and after treatment. We use two methods to evaluate the efficacy of our
      treatments: questionnaires and interviews with a member of the Anxiety Disorders Clinic. As
      part of standard clinic procedure, each person in the program completes an in-person
      interview with a staff member who will determine your suitability for treatment. If you have
      received this questionnaire packet, it is likely that your concerns will be appropriately
      addressed in the Anxiety Disorders Clinic. The purpose of the questionnaire packet is to
      assess the severity of your obsessive-compulsive disorder; its impact on your functioning,
      and factors that may contribute to the onset or maintenance of your OCD (e.g., depression,
      personal standards). We will ask you to complete this questionnaire again when you have
      completed your treatment along with a brief telephone interview with a staff member of the
      Anxiety Disorders Clinic.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Participants in the study will be recruited from individuals receiving treatment at the
        Anxiety Disorders Clinic of UBC Hospital.
      
Keywords: Obsessive Compulsive Disorder; Anxiety; Treatment efficacy
Flucloxacillin as an Inducer of CYP-enzymes
Condition: Healthy Volunteers; Drug Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      Worldwide there is an increase in antibiotic resistance which may have potential fatal
      long-term consequences. This is due to extensive use and sometimes misuse of antibiotics in
      the treatment of harmless infections.

      The aim of this study is to investigate if treatment with flucloxacillin increases drug
      metabolism in healthy volunteers through induction of cytochrome P450 (CYP) enzymes, CYP1A4,
      CYP2B6, CYP2C9, CYP2C19, CYP2D6, and CYP3A4.

      The hypothesis is based on an in vitro study showing that flucloxacillin activates a receptor
      (PXR) responsible for transcription of CYP enzymes.

      Trial subjects will ingest flucloxacillin for 31 days and at day 10 and 28 ingest a cocktail
      of 6 drugs to determine if the CYP enzymes have been induced. Plasma and urine will be drawn
      over 72 hours to determine the concentration of the 6 drugs and their metabolites.

      Change in flucloxacillin concentration will also be measured at day 9 and 27 to establish if
      flucloxacillin induces its own metabolism.
    


Intervention name(s): Flucloxacillin
Intervention type(s): Drug
Intervention description(s): Healthy volunteers will take 2x500 mg flucloxacillin 3 times a day for 31 days. The investigators will measure the baseline concentration of the 6-cocktaildrugs and flucloxacillin before start of 31 days of flucloxacillin treatment. On day 9 and 27 the investigators will measure the concentration of flucloxacillin. On day 10 and 28 the investigators will measure the concentration of the 6 cocktaildrugs
Other intervention name(s): Caffeine; Efavirenz; Losartan; Omeprazole; Metoprolol; Midazolam
Intervention MeSH terms: Efavirenz; Floxacillin; Losartan; Metoprolol; Midazolam; Caffeine; Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: CYP enzymes; Induction of CYP enzymes
Early Intensive Physical Therapy in Subarachnoid Hemorrhage
Condition: Subarachnoid Hemorrhage
MeSH terms: Subarachnoid Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      This study will investigate the safety and feasibility of early intensive physical therapy
      for patients diagnosed with subarachnoid hemorrhage. Intervention will begin in the
      neurological Intensive Care Unit (ICU) and continue for 30 days or hospital discharge.
    


Intervention name(s): Physical Therapy
Intervention type(s): Other
Intervention description(s): Early Intensive Physical therapy in the ICU
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Physical Therapy, early intervention
Control of Hypertension by Non-Pharmacologic Means
Condition: Cardiovascular Diseases; Heart Diseases; Hypertension; Vascular Diseases
MeSH terms: Hypertension; Cardiovascular Diseases; Heart Diseases; Vascular Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine whether blood pressure could be controlled by nutritional-hygienic,
      non-pharmacologic means in hypertensives treated with drugs in the Hypertension Detection and
      Follow-up Trial (HDFP).
    

Detailed description: 
      BACKGROUND:

      In the 1970s, many studies had been conducted to control blood pressure in individuals
      maintained at normotensive levels by the use of weight control and sodium restriction without
      the concomitant use of anti-hypertensives. The associations between weight, sodium and blood
      pressure had been well established, but data on the relationship of intervention to blood
      pressure control had been less so.

      DESIGN NARRATIVE:

      Patients were randomly assigned to one of three groups. The 95 patients in Group I were
      advised to control weight, reduce sodium intake, modify dietary and alcohol intake and were
      removed from pharmacologic treatment. The 44 patients in Group II were removed from
      pharmacologic treatment, with no other intervention. The 48 patients in Group III were
      continued on pharmacologic treatment, with no other intervention. The primary endpoint was
      the proportion in Groups I and II with diastolic blood pressure less than or equal to 90 mm
      Hg in the absence of antihypertensive drugs. Secondary endpoints were average diastolic and
      systolic pressures.

      The study completion date listed in this record was obtained from the CRISP legacy data.
    

Intervention name(s): diet, sodium-restricted; diet, reducing; alcohol restriction; antihypertensive agents
Intervention type(s): Behavioral; Behavioral; Behavioral; Drug
Intervention MeSH terms: Antihypertensive Agents
Allocation: Randomized
Primary purpose: Treatment
Effects of Mirror Therapy on Pain and Function on Bilateral Carpal Tunnel Syndrom
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate pain and function after mirror therapy as well as
      level of catastrophism in bilateral carpal tunnel syndrome patients
    

Detailed description: 
      The sample calculation was performed based on the previous pilot study, in which 10 subjects
      were included. Through this study, a statistically significant effect on the variables
      analyzed was demonstrated. Therefore, it was determined to duplicate the initial sample to
      confirm the effect previously studied, assuming losses of 20%. Thus, the value of n for the
      clinical trial is 20 subjects.
    

Intervention name(s): Mirror therapy; Placebo group
Intervention type(s): Other; Other
Intervention description(s): The treatment proposed for the mirror group consisted of 8 weeks of treatment, performing a series of exercises 2 times a day / 4 times a week. The first 4 weeks the treatment was done in the hospital next to the physiotherapist for 2-3 days a week, and the next 4 weeks the patient performed the exercises following the same guidelines at home.; The treatment was the same than proposed in inference group but with a mirror covered to avoid the reflexion on the hand and looking at the hand that did not remain hidden.
Other intervention name(s): Mirror visual feedback; Mirror box therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adult; Chronic pain; Entrapment neuropathy. Carpal tunnel; Exercise therapy; Humans; Neuronal plasticity; Mirror neurons; Pain/cognitive aspects; Physiotherapy; Somatosensory cortex
Occupational Therapy-Based Cognitive Rehabilitation of Cocaine Abusers: A Pilot Study
Condition: Mild Cognitive Impairment, So Stated; Cocaine Use Disorder
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      This study integrates a model of occupational-therapy based cognitive rehabilitation as part
      of a comprehensive treatment plan for cocaine abusers. We hypothesize that cognitive
      impairment and quality of life would improve and that cocaine use would decrease in those
      participants receiving occupational-therapy based cognitive rehabilitation.
    

Detailed description: 
      occupational-therapy based cognitive rehabilitation as part of a comprehensive treatment plan
      for cocaine abusers
    

Intervention name(s): Occupational therapy-based cognitive rehabilitation; Psychoeducation/games
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Occupational therapy-based cognitive rehabilitation; Psychoeducation/games
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cocaine; Cognitive Impairment; Cognitive Rehabilitation