bioihbjkbjnl/mcl2 huggingface dataset:
Tension Free Vaginal Tape Surgery - Follow up After 10 and 20 Years
Condition: Urinary Incontinence,Stress
MeSH terms: Urinary Incontinence; Urinary Incontinence, Stress
Study type: Observational

Summary: 
      Over the past 5-7 years there has been increasing concern about the use of polypropylene
      tapes in female incontinence surgery. There has been a special focus on pain in the vagina
      and lower abdomen and pain during sexual intercourse. Some have also asked if the
      polypropylene tape could cause impairment of the immune system leading to allergy, connective
      tissue disorders etc. There are still only a few publications on complications after sling
      surgery.

      In Norway it is mandatory to register all incontinence surgery in the National incontinence
      registry (Norsk Kvinnelig Inkontinens Register (NKIR). In 2019 >99 % of all procedures were
      registered in this registry. Data about type and severity of incontinence are registered, as
      well as complications at surgery. The same data are entered at a 6 months and 3 years follow
      up. Data for the follow up visits are not complete. The NKIR registry and other similar
      registries have been criticized for not following the women long enough and therefore missing
      important information regarding long-term complications. Few studies have followed the women
      for a longer time after surgery. The main aim of this study is to find the prevalence of
      women still satisfied with the TVT surgery and the prevalence of long-term complications
      after 10 and 20 years.
    


Intervention name(s): Tension-free vaginal tape
Intervention type(s): Procedure
Intervention description(s): female incontinence surgery with polypropylene tape applied
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Women who had tension free vaginal tape surgery 10 and 20 years ago in Norway, identified
        in the National Incontinence Registry (Norsk Kvinnelig Inkontinens Register (NKIR).
      
Keywords: Surgery; Suburethral Slings; Tension-free vaginal tape
An Italian Study of the Efficacy of Atomoxetine in the Treatment of Children and Adolescents With Attention-Deficit/Hyperactivity Disorder (ADHD) and Comorbid Oppositional Defiant Disorder (ODD).
Condition: Attention Deficit Hyperactivity Disorder; Oppositional Defiant Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Attention Deficit and Disruptive Behavior Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is a phase IIIb multicentre, randomised, placebo controlled, trial in paediatric
      patients with Attention-Deficit/Hyperactivity (ADHD) and Oppositional Defiant Disorder (ODD).
      The primary aim of the study is to evaluate the efficacy of atomoxetine in improving ADHD and
      ODD symptoms in patients non responders to a previous psychological intervention with parent
      support. Moreover, the potential role of atomoxetine in treating other psychiatric comorbid
      conditions associated with ADHD and ODD will be assessed.
    


Intervention name(s): atomoxetine 0.5 mg/kg/day; placebo; atomoxetine 1.2 mg/kg/day; atomoxetine 1.2-1.4 mg/kg/day
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): atomoxetine 0.5 milligrams per kilogram per day (mg/kg/day) daily (QD), by mouth (PO); atomoxetine 1.2 mg/kg/day QD, PO; atomoxetine 1.2 - 1.4 mg/kg/day QD, PO
Other intervention name(s): LY139603; Strattera; LY139603; Strattera; LY139603; Strattera
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study Evaluating the Safety and Efficacy of Curcumin in Patients With Primary Sclerosing Cholangitis (PSC)
Condition: Primary Sclerosing Cholangitis
MeSH terms: Cholangitis; Cholangitis, Sclerosing
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether curcumin, a drug and naturally-occurring
      plant compound, is safe and effective in the treatment of primary sclerosing cholangitis
      (PSC).
    


Intervention name(s): Curcumin
Intervention type(s): Drug
Intervention description(s): Subjects will receive one 750 mg softgel by mouth twice a day for 12 weeks. Each each 750 mg CuraMed® softgel supplies 500 mg of highly bioavailable BCM-95 curcumin.
Other intervention name(s): CuraMed® softgel
Intervention MeSH terms: Curcumin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Fluoride Varnish and CPP-ACP on Oral and Salivary Symptoms During Chemotherapy
Condition: Mucositis; Dry Mouth; Infection
MeSH terms: Mucositis; Xerostomia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to investigate the effect of Fluoride varnish and Casein
      Phospho-Peptide Amorphous Calcium Phosphate (CPP-ACP) containing paste on oral symptoms and
      salivary characteristics in patients under chemotherapy.
    

Detailed description: 
      Chemotherapy as a treatment method of cancers, affects different parts of the oral cavity
      such as oral mucosa, teeth and salivary glands caused by salivary glands dysfunction during
      chemotherapy.Oral status of patients under chemotherapy will be affected by consumption of
      the drugs and their side effects such as reduction of the saliva, dryness of the oral cavity,
      changes in bacterial balance, oral mucosa damage, bleeding due to irritation of the tissues,
      xerostomia, dental caries, burning sensation, dysgeusia and dysphagia. No effective
      preventive protocol has been presented for oral care during chemotherapy.

      Patients who were met the inclusion criteria (aged over 12, diagnosed to have cancer by an
      oncologists and needed chemotherapy drugs, had at least 20 teeth, had no other pathologic
      lesion in their oral cavity, were not treated by radiotherapy and did not have specific
      systemic diseases or head and neck cancer) were selected for the study. the participants were
      evaluated according to oral and salivary symptoms.
    

Intervention name(s): Fluoride varnish; Oral Hygiene; CPP-ACP
Intervention type(s): Drug; Other; Drug
Intervention description(s): Fluoride Varnish (NaF 5%); Oral hygiene followed.; CPP-ACP paste was applied by patient, once daily.
Other intervention name(s): Fluoride varnish(NaF 5%,Sultan,USA); Twice daily (tooth brush and tooth paste).; CPP-ACP Paste was used in this group.; 3 gr , once daily , 42 days.
Intervention MeSH terms: Fluorides; Fluorides, Topical
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Fluoride Varnish; CPP-ACP paste; Dry mouth; Burning sensation; Chemotherapy
Patients With Higher BMI Produces More Postoperative Drainage Volume and Length of Stay in Cross-Sectional Study
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Observational

Summary: 
      Partial knee arthroplasty theoretically produces less blood loss compared to total knee
      arthroplasty (TKA) due to a lesser invasive procedure. Medial unicompartmental knee
      arthroplasty (UKA) is the most common partial knee arthroplasty performed due used due to the
      most commonly impacted medial knee. This study compared the postoperative drainage volume and
      length of stay (LOS) of TKA vs UKA and evaluated its comparison with patient characteristics.
    

Detailed description: 
      Theoretically, UKA will produce less blood loss due to a shorter skin incision, quadriceps
      sparing muscle approach, persistence of cruciate ligaments, and less femorotibial
      dislocation.7 However, studies investigating drainage volume in UKA are still limited. In
      this study, we compared the drainage volume of patients undergoing TKA vs UKA and evaluated
      several parameters that contributed the production. This study has not received any funding
      or grant.
    

Intervention name(s): Knee Replacement
Intervention type(s): Procedure
Intervention description(s): Total vs Partial Knee Replacement
Observational model: Case-Crossover
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        medical records of patients who underwent primary TKA and UKA between December 2019 and
        October 2022
Exploratory Clinical Study of MT-2301
Condition: Haemophilus Influenza Type b
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate efficacy and safety of MT-2301 when co-administered
      with DPT-IPV using ActHIB® as a control in healthy infants.
    


Intervention name(s): Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-Low + DPT-IPV; Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-High + DPT-IPV; Haemophilus influenza type b conjugate vaccine + DPT-IPV
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.25mL, subcutaneous injection; 0.5mL, subcutaneous injection; 0.5mL, subcutaneous injection
Other intervention name(s): MT-2301-Low + Tetrabik®; MT-2301-High + Tetrabik®; ActHib® + Tetrabik®
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Haemophilus influenza type b; Hib
Clinical Trial to Explore the the Amyloid Beta Draining Effect of Thiethylperazine (TEP) in Subjects With Newly Diagnosed Early-to-mild Dementia Due to Alzheimer's Disease (AD) in Comparison to Healthy Volunteers
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease; Dementia
Study type: Interventional
Phase: Phase 2

Summary: 
      This proof-of-mechanism clinical trial study will test the efficacy and safety of
      thiethylperazine (TEP) in subjects with early onset of Alzheimer's Disease (AD). There is a
      strong scientific rationale for this study: TEP is a very well-known substance that has been
      available since 1961 and approved for the prevention and treatment of nausea, vomiting as
      well as vertigo. Therefore, it has a well understood pharmacologic background and promising
      safety data. Using AD mouse models, it has been recently discovered and confirmed that TEP
      promotes transport of toxic Aβ from the brain into the blood. More importantly, it has also
      been demonstrated to improve learning deficits in mice. The striking biological effect of TEP
      in preclinical testing and its known safety and toxicity profile encourages the investigators
      to investigate this in a multicenter clinical trial in subjects with early-to-mild AD in
      comparison to healthy volunteers. The investigators will assess whether TEP is able to
      enhance the transport of Aβ peptides from the brain into the blood in subjects with
      early-to-mild AD and improves cognitive efficacy.
    


Intervention name(s): TEP
Intervention type(s): Drug
Intervention description(s): For safety reasons the clinical trial will first enroll 14 subjects (7 patients and 7 healthy volunteers) for Group 1a receiving 26 mg TEP daily for 4 days with subsequent safety evaluation, based on adverse events and the safety parameters discussed in the protocol. A second set of patients (Group 1b), which will receive a higher dosage of 52 mg per day for 4 days will be enrolled optionally after recommendation to continue and subsequently treatment Group 2 with a treatment paradigm of 26 mg TEP daily for 54 days will start.
Subjects eligible for participation are subjects with newly diagnosed (within last 12 month) early-to-mild dementia due to AD and healthy volunteers who fulfill all inclusion criteria and have none of the exclusion criteria present at screening.
Other intervention name(s): Thiethylperazine
Intervention MeSH terms: Thiethylperazine
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Thiethylperazine; Alzheimer Disease
Study of Aldafermin (NGM282) in Subjects With Compensated Cirrhosis (ALPINE 4)
Condition: Compensated Cirrhosis; Nonalcoholic Steatohepatitis
MeSH terms: Liver Cirrhosis; Fatty Liver; Non-alcoholic Fatty Liver Disease; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      A multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled
      study in subjects with compensated cirrhosis.
    

Detailed description: 
      The study will compare multiple doses of aldafermin against placebo in a compensated NASH
      cirrhosis population for 48 weeks of treatment.
    

Intervention name(s): aldafermin; Placebo
Intervention type(s): Biological; Other
Intervention description(s): aldafermin; Placebo for aldafermin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Pilates Exercises on Core Stability After Recovery From COVID -19
Condition: Covid19; Pilates, Core Stability
Study type: Interventional

Summary: 
      This study will be conducted in the Department of physical therapy, College of Applied
      Medical Sciences,Jazan University, to Effects of Pilates Exercises on core stability after
      Recovery from COVID - 19
    

Detailed description: 
      145 male and female students who had infected with covid 19 with age 19 to 26 years old, will
      be recruited from the College of Applied Medical Sciences, Jazan University. Subjects will be
      randomly assigned to a pilates and home exercises (PAH) group or a control group who will
      perform only home exercises (COH)

      Four core endurance tests will be performed to assess the core stability

      Pilates exercise program will be composed of Pilates mat exercise program for a period of 12
      weeks and three sessions every week.

      Each session took one hour. Every session started with 10 minutes of simple stretching
      movements to warm-up followed by the main part of the exercise plan for 40 min, followed by
      10 minutes, some cool-down stretching.

      When the 12-week study period will over, the core stability will be assessed by the endurance
      tests and Prokin system for balance
    

Intervention name(s): Pilates Exercises; Home Exercise program
Intervention type(s): Other; Other
Intervention description(s): basic five pilates intermediate workout based on the principles of Pilates; home exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomly assigned to two groups:
pilates and home exercises (PAH) group
home exercises group (COH)
Masking: None (Open Label)
Primary purpose: Treatment
Dexmedetomidine for Reversal of Cocaine's Effects on the Heart
Condition: Chest Pain; Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Chest Pain
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study will use myocardial contrast echocardiography performed during a continuous
      intravenous infusion of Definity microbubbles (Perflutren lipid microbubbles) to determine if
      dexmedetomidine (an intravenous central sympatholytic drug) can reverse all the
      cardiovascular effects of low-dose intranasal cocaine-including vasoconstriction in the
      coronary microcirculation-both in cocaine-naïve and non-treatment seeking cocaine-addicted
      subjects.
    

Detailed description: 
      Each subject will be participating in three study visits: Screening Visit, Visit 1: a
      low-dose dobutamine visit and Visit 2: a low-dose cocaine visit. At the dobutamine visit, the
      subject will only receive low-dose dobutamine, which will be used as an internal
      inotropic/vasodilator control for cocaine. At the cocaine visit, the subject will receive
      low-dose intranasal cocaine followed by either the active study drug (dexmedetomidine) or an
      inactive placebo (saline). Both cocaine and dobutamine will increase myocardial contractility
      and oxygen demand, thereby stimulating metabolic vasodilation. If, as predicted, cocaine also
      causes α-adrenergic agonist in the coronary microcirculation, then myocardial blood flow
      should increase less with cocaine then with dobutamine for a given level of myocardial oxygen
      demand. We will study if dexmedetomidine, a central sympatholytic, can normalize this cocaine
      effect. We previously have used dobutamine as a comparator for cocaine in our research. At
      both visits, myocardial contrast echocardiography will be used to measure regional myocardial
      perfusion.
    

Intervention name(s): Dexmedetomidine; Normal Saline; Intranasal cocaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dexmedetomidine (0.3-0.6 mcg/kg) infusion.; Normal saline infusion (10 cc); Intranasal cocaine (2 mg/kg)
Other intervention name(s): Precedex
Intervention MeSH terms: Cocaine; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cocaine; Dexmedetomidine; Myocardial Contrast Echocardiography
Development of a Mobile Application to Promote Self-care in Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The purpose of this study is to test the efficacy of a mobile application named ProFibro to
      promote self-care, and improve symptoms and health-related quality of life in Brazilian
      patients with fibromyalgia.
    


Intervention name(s): ProFibro (Mobile application); Paper booklet
Intervention type(s): Device; Device
Intervention description(s): ProFibro, a mobile Android application in Brazilian Portuguese to promote self-care in patients with fibromyalgia; A 64-page booklet with content similar to the mobile application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: fibromyalgia; mobile application; self-care; quality of life
Therapeutic Approaches for Subjects With Scapula Dyskinesis
Condition: Shoulder Impingement
MeSH terms: Shoulder Impingement Syndrome; Dyskinesias
Study type: Interventional

Summary: 
      The investigators will test whether conscious control with manual guides and video or EMG
      biofeedback will enhance 3-D kinematics of scapula in shoulder dysfunction subjects with
      different type of scapula dyskinesis. The investigators will also examine how correction of
      scapular orientation may affect the activation of associated muscles during various dynamic
      movements in these subjects.
    


Intervention name(s): Conscious control; Conscious control+biofeedback
Intervention type(s): Other; Other
Intervention description(s): Conscious control of the scapula is important and can correct neuromuscular coordination as well as strength deficits. The strategy in learning control of scapula into normal orientation can be facilitated by manual guides and/or external cues; In electromyography (EMG) biofeedback training, electronic equipment is used to reveal instantaneously certain physiological events.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Shoulder dyskinesis; EMG biofeedback training; Intensive Scapula-focused intervention
Bee Venom Acupuncture for the Treatment of Frozen Shoulder
Condition: Frozen Shoulder
MeSH terms: Bursitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effectiveness of combined bee venom acupuncture
      (BVA) and physiotherapy (PT) on frozen shoulder, and whether if the effect of BVA is dose
      effective.
    


Intervention name(s): 1:10,000 bee venom (BV) acupuncture; 1:30,000 bee venom (BV) acupuncture; normal saline injection; physiotherapy
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): after skin test for hypersensitivity to bee venom (0.05ml of 1:30,000 bee venom, SC at LI11)
1st visit : SC 0.4ml of 1:10,000 BV at 4 points (0.1ml for each points)
2nd visit : SC 0.6ml of 1:10,000 BV at 6 points (0.1ml for each points)
3rd visit : SC 0.8ml of 1:10,000 BV at 8 points (0.1ml for each points)
4th to 16th visit : SC 1.0ml of 1:10,000 BV at 10 points (0.1ml for each points); after skin test for hypersensitivity to bee venom (0.05ml of 1:30,000 bee venom, SC at LI11)
1st visit : SC 0.4ml of 1:30,000 BV at 4 points (0.1ml for each points)
2nd visit : SC 0.6ml of 1:30,000 BV at 6 points (0.1ml for each points)
3rd visit : SC 0.8ml of 1:30,000 BV at 8 points (0.1ml for each points)
4th to 16th visit : SC 1.0ml of 1:30,000 BV at 10 points (0.1ml for each points); after skin test for hypersensitivity to bee venom (0.05ml of 1:30,000 bee venom, SC at LI11)
1st visit : SC 0.4ml of normal saline at 4 points (0.1ml for each points)
2nd visit : SC 0.6ml of normal saline at 6 points (0.1ml for each points)
3rd visit : SC 0.8ml of normal saline at 8 points (0.1ml for each points)
4th to 16th visit : SC 1.0ml of normal saline at 10 points (0.1ml for each points); Physiotherapy treatment will be provided at each visit after bee venom or saline injection.
transcutaneous electrical nerve stimulation (TENS) for 15 minutes
transcutaneous infrared thermotherapy (TDP) for 15 minutes
manual physical therapy for 15 minutes
simple home exercise program
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: frozen shoulder; bee venom acupuncture
Interventional Study on the Evaluation of Functionality, Safety of a Robotic Prosthesis for Transtibial Amputations
Condition: Amputation; Amputation; Traumatic, Leg, Lower
MeSH terms: Amputation, Traumatic
Study type: Interventional

Summary: 
      The goal of this multicenter interventional pilot is to verify the functionality of a
      prosthesis for trans-tibial amputees.

      The main question it aims to answer are:

        -  Is to verify the technical functionality, safety and reliability of the propulsive lower
           limb prosthesis prototype, with active ankle, so as to provide indications regarding the
           technical and functional developments to be implemented in the finalization of the
           device.

        -  Provide an indication of the functional effectiveness of the device and its satisfaction
           by patients.

      Participants will perform:

        -  walking tests inside parallel bars on flat and/or inclined terrain;

        -  walking tests on treadmill;

        -  stair climbing/descent tests.
    


Intervention name(s): WRL TTP
Intervention type(s): Device
Intervention description(s): evaluation of functionality, degree of safety and reliability of the lower limb prosthesis prototype
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: lower limb; transtibial