bioihbjkbjnl/mcl2 huggingface dataset:
A Prospective Study on USS Assessment of Pelvic Structures in 3rd Trimester of Pregnancy Versus Delivery Outcome
Condition: Pelvic Floor Disorders; Pregnancy
MeSH terms: Pelvic Floor Disorders
Study type: Interventional

Summary: 
      The proposed study is to evaluate if there are specific factors in the pelvic floor
      functional anatomy which can predict the ability of having a vaginal birth after caesarean
      section.

      Physical characteristics of the soft tissue in the female pelvis play an important role in
      successful vaginal delivery. A "tight" or less distensible pelvic floor muscles may influence
      mode of delivery, leading to poor labour progression and by compressing foetal head produce
      CTG abnormality such as decelerations, both resulting in caesarean delivery.

      One of the main structures of the pelvic floor, the puborectoalis muscle, facilitates the
      passage of fetal head through the birth canal by stretching and distending. Therefore
      distensibility of the female pelvic floor influences mode of delivery.

      Three hundred patients, in the third trimester of pregnancy, will be recruited via the
      antenatal clinics to minimize any disruption in their pregnancy care provision. Eligible
      participants are pregnant women who had either one or no vaginal births, or one caesarean
      section and who can give an informed consent and maintain their autonomy regarding mode of
      delivery with understanding of the forthcoming study results. Participants will be excluded
      if they sustain any obstetric complications that may impede on time and mode of delivery
      including an emergency prelabour caesarean section.

      Ultrasonographic assessment of the differences in the pelvic characteristics of these women
      will be used to predict a successful of trial of vaginal delivery after caesarean section
      (VBAC) in subsequent pregnancies. The results will be used to better inform whether there is
      a simple (single ultrasound assessment) that can be used to help inform women's choice
      regarding mode of delivery.

      Results from this research could be a pioneering blueprint for further studies, as there is
      very little known about this topic.
    


Intervention name(s): ultrasound; uroflow-meter
Intervention type(s): Procedure; Procedure
Intervention description(s): pelvic floor ultrasound; uroflow meter: measurement of passed urine volume
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Floating for Chronic Pain
Condition: Chronic Pain Syndrome
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      In recent years there has been a novel approach for the treatment of chronic pain: Floatation
      REST (restricted environmental stimulation therapy). Floating is a therapeutic approach, in
      which patients float in a specialized pool or tank on water that contains high concentrations
      of Epsom salt (Magnesium sulfate). Water is kept at skin temperature (35-36°C) and the pool
      or tank is shielded to provide almost complete darkness and silence. This therapeutic
      approach has proven to be effective in alleviating chronic pain.

      Due to the difficulties associated with designing a credible placebo control there have been
      no randomized controlled trials (RCTs) with patients blinding so far. Such blinding, however,
      is crucial, to assess the true therapeutic effect of the intervention.

      The investigators will conduct the first patient blinded RCT of Floatation REST for chronic
      pain with a credible placebo control for floating and a no-treatment group.
    


Intervention name(s): Floating; Placebo floating
Intervention type(s): Other; Other
Intervention description(s): Floating in specialized tank with full floatation and sensory deprivation.; Floating in specialized tank with reduced floatation and sensory deprivation.
Other intervention name(s): Floatation REST
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Somatic and psychological factors
NAC Prevents Toxicity of Teeth Bleaching
Condition: Removal of Toxicity From Dental Bleaching
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Dental bleaching is a simple procedure for aesthetic restoration of vital and non-vital
      discolored teeth. Nevertheless, a number of studies conducted previously demonstrated the
      risk of tissue damage from contact of these agents with the oral mucosa along with their
      possible genotoxic potential after exposure to oral mucosa. Hence the aim of this study is to
      conduct a human clinical trial to incorporate the chemoprotectant N-acetyl cysteine (NAC) in
      the procedure of bleaching which could safely be used to eliminate the toxicity of bleaching
      materials leaving their esthetic benefits intact. 30-40 human subjects will be recruited and
      bleaching will be done at the UCLA School of Dentistry dental clinic.
    


Intervention name(s): NAC; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): solution containing NAC; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: bleaching, toxicity, NAC
Effects of Legume Consumption on Adiponectin and Inflammatory Markers Among Adults
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of this randomized cross-over study was to determine the effects of legume
      consumption on adiponectin and inflammatory factors among first degree relatives of diabetic
      patients
    


Intervention name(s): nutritional intervention; life style intervention
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Monitoring Asthma Treatment Using Exhaled Nitric Oxide
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Asthma is a chronic inflammatory condition in which the airways develop increased
      responsiveness to various stimuli such as exposure to an allergen, cold air or exercise. It
      is characterized by airway hyper-responsiveness, inflammation, increased mucus production,
      and airway obstruction. Since inflammation is an important feature of asthma, the use of
      non-invasive tests to measure lung inflammation to monitor asthma are of interest.The purpose
      of the study is to relate costs associated with healthcare utilization and loss of work and
      school time to the primary health outcome of cumulative number of symptom-free days. This
      will enable the researchers to determine whether the costs of monitoring exhaled NO to
      regular management strategy in recently diagnosed asthma will be offset by reductions in
      other costs of asthma-related care, and, if not, whether the additional costs are likely to
      be acceptable in terms of the improvement in health outcomes as measured by the additional
      number of symptom-free days.
    


Intervention name(s): measurement of exhaled NO is used to guide treatment
Intervention type(s): Device
Intervention description(s): exhaled NO
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        asthmatic children
      
Keywords: exhaled NO; asthma; child
Evaluation of the COGNISION(TM) System as an Event-related Potential (ERP) Collection System.
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Observational

Summary: 
      This study will evaluate a handheld event-related potential (ERP) testing device from
      Neuronetrix, Inc. as a method to collect ERP data in an outpatient setting.

      An ERP system records electrical signals at the scalp that are produced by the brain when
      performing cognitive tasks. By doing this study, we hope to evaluate various performance
      parameters of the COGNISION(TM) system.
    

Detailed description: 
      Patients who have a current diagnosis of mild-moderate dementia and suspected of having
      Alzheimer's disease (AD) along with cognitively normal age-matched controls will be recruited
      for this study. The Alzheimer's subjects either will have had a complete clinical and
      neuropsychiatric workup or will have those tests performed during the study.

      Both groups, AD and controls will be asked to listen to a series of sounds and press a button
      on a handheld control box when a target sound is heard. The COGNISION(TM) headset on each
      subject's head will then record the electrical signals during this task.

      Four important features of the COGNISION(TM) will be investigated:

        1. Patient tolerance

        2. Ease of use

        3. Data quality

        4. Network architecture
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients and family from the University of Kentucky Sanders Brown Center for Aging
      
Keywords: senile; dementia
Effects of High Intensity Inspiratory Muscle Training on Exercise Capacity in Patients With Bronchiectasis
Condition: Bronchiectasis
MeSH terms: Respiratory Aspiration; Bronchiectasis
Study type: Interventional

Summary: 
      Reduced exercise tolerance is commonly reported in patients with bronchiectasis. The purpose
      of this study is to evaluate the effects of high-intensity inspiratory muscle training
      (High-IMT) and sham High-IMT (control) on exercise capacity, respiratory muscle function
      (strength and endurance) and health related quality of life in patients with bronchiectasis.
    

Detailed description: 
      Bronchiectasis often demonstrates decreased exercise tolerance, marked dyspnea and fatigue.
      The causes are multifactorial and include altered pulmonary mechanics, inefficient gas
      exchange, decreased muscle mass, and psychological status, which all lead to a progressive
      detraining effect. Essentially both the pathology and the functional manifestations of
      bronchiectasis increase the demand for inspiratory muscle work and that contribute to dyspnea
      and exercise limitation.

      In recent studies reduced strength of respiratory muscles are investigated in bronchiectasis
      and can be contribute the exercise limitation. Additionally IMT has shown to improve
      respiratory muscle function, exercise tolerance and dyspnea in patients with bronchiectasis.
      Despite this, the number of studies are inadequate and so the optimal training protocol
      remains still to be defined. In this study the researchers want to investigate the effects of
      high-intensity inspiratory muscle training in functional results in patients with
      bronchiectasis.
    

Intervention name(s): Inspiratory muscle training group
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Bronchiectasis; High-intensity inspiratory muscle training
A Pharmacodynamics, Pharmacokinetics, and Safety Study of Hydrochlorothiazide and Canagliflozin in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the effects of multiple doses of hydrochlorothiazide
      and canagliflozin on the concentrations of each drug in the blood and the concentration of
      glucose in the blood and urine in healthy adult volunteers.
    

Detailed description: 
      This is a single-center, open-label study with 2 study periods where volunteers and study
      staff will know the names and doses of assigned study treatments. All volunteers will receive
      the same treatment. Canagliflozin (a sodium-glucose cotransporter 2-inhibitor) is currently
      under development to lower blood sugar levels in patients with Type 2 diabetes mellitus
      (T2DM), and hydrochlorothiazide (HCTZ) is a drug indicated for the treatment of patients with
      mild to moderate hypertension. During Period 1, volunteers will take canagliflozin 300 mg
      once daily for 7 days (Days 1 to 7) and during Period 2, volunteers will take HCTZ 25 mg once
      daily for 28 days (Days 1 to 28), and then starting on Day 29, will take canagliflozin 300 mg
      once daily and HCTZ 25 mg once daily for 7 days (Days 29 to 35). Period 1 and Period 2 will
      be separated by a minimum of 14 days.
    

Intervention name(s): Canagliflozin 300 mg once daily and HCTZ 25 mg once daily
Intervention type(s): Drug
Intervention description(s): Period 1: canagliflozin tablets, oral, 300 mg, once daily on Days 1 to 7 followed 14 days later by Period 2.
Period 2: HCTZ tablets, oral, 25 mg, once daily for Days 1 to 28 followed by canagliflozin tablets, oral, 300 mg, once daily taken with HCTZ tablets, oral 25 mg, once daily on Days 29 to 35..
Intervention MeSH terms: Canagliflozin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Canagliflozin; JNJ-28431754; Hydrochlorothiazide; Pharmacokinetic; Pharmacodynamic
Pilot Trial to Assess the Feasibility of Implementing Objective Parameters in Patients Affected by Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Pilot, open non-controlled trial to assess the feasibility of implementing objective
      parameters as primary endpoints in a clinical trial with patients affected by knee
      osteoarthritis.
    

Detailed description: 
      • to assess the feasibility of implementing ultrasonography and Range of motion (ROM) as
      objective measurements to correlate the improvement of the knee mobility with the pain
      reduction of the affected knee in the patients assuming nutraceutical containing HA.

      The secondary objectives of the trial are:

        -  to assess the feasibility of implementing Actigraphy as objective measurements to
           correlate the improvement of the knee mobility with the pain reduction (optional).

        -  to evaluate the enrollment range in one month.

      The explorative objectives of the trial are:

      • Preliminary data on efficacy of the tested product
    

Intervention name(s): patients assuming nutraceutical containing HA
Intervention type(s): Dietary Supplement
Intervention description(s): pain reduction of the affected knee in the patients assuming nutraceutical containing HA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Information Visualizations to Enhance HIV-related Communication
Condition: HIV; Communication Research
Study type: Interventional

Summary: 
      HIV disproportionately affects Latinos who have more infections, faster disease progression,
      more HIV-related deaths, and slower diagnosis and treatment than their white/majority
      counterparts. This is a concern across the United States (US) and in developing countries,
      such as the Dominican Republic (DR). The HIV-related health disparities experienced by
      Latinos are made worse when those living with HIV have low health literacy and difficulty
      understanding the information they need to manage their health.

      The PI developed a set of images to assist clinicians in providing information to Latino
      people living with HIV (PLWH). These images have been put into a mobile health app so
      clinicians can easily access them during clinic visits. The PI has tested her with PLWH in
      the DR and in New York City. So, the next steps in this research are to ensure the images are
      relevant and useful to Latinos across the United States (US) and to further assess if, and to
      what extent, the images can improve health outcomes among PLWH in the US and in the DR. We
      will therefore, adapt images to Latinos of Mexican origin/descent and then test them to
      determine if these images help clinicians provide information to patients by conducting a
      study at clinical sites in the US and in the DR.
    


Intervention name(s): Info Viz for Health
Intervention type(s): Other
Intervention description(s): During the intervention, health care providers provide HIV-related health education using a mobile app that contains a bilingual database of relevant infographics.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There is a treatment and a control group at each site.
Masking: Single (Investigator)
Primary purpose: Health Services Research
Keywords: Health literacy; HIV; Infographic; Information-visualization; Clinician-patient communication; Health education
Dicloxacillin: Clinical Relevance of Drug-drug Interactions by Induction of Drug Metabolism.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted as a cocktail-study namely an open-label, randomized, two-sequence,
      two-period crossover, cocktail study where a combination of cocktail-drugs is used to
      illustrate whether or not, or to what degree dicloxacillin affects the level of activity of
      the 5 most important CYP enzymes and therefore plays a potentially decisive role in serious
      drug-drug interactions.
    

Detailed description: 
      Given knowledge explains dicloxacillin and the drug warfarin to be a potential dangerous drug
      drug interaction because the effects of warfarin is downregulated to a degree as to where it
      might cause patients to have thrombotic events.

      A potential explanation to this is namely dicloxacillin increases the activity of certain
      drug metabolising enzymes metabolising warfaring which in turn decreases the concentration of
      the drug in the blood and the therapeutic effect.

      Cocktail study is the golden standard to investigate as to whether there is changes is P450
      enzymes as a result of drug-drug interactions.

      The cocktail consists of Midazolam, omeprazole, tolbutamide, caffein and dextromethorphan
      which is well known markers for these enzymes. These markers are safe, have specific (enzyme)
      metabolism and has been used in several studies with no Serious Adverse reactions reported.

      By measuring the Concentration of the drug and its metabolites in plasma / Urine before and
      after treatment with dicloxacillin we will estimate AUC (area under the curve) and test our
      hypothesis/primary end point of whether there is change in AUC for Tolbutamide (CYP2C9)
    

Intervention name(s): Dicloxacillin; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Tablets containing dicloxacillin are taken 500mg 2x 3 times per day, for 10 days. Followed by test-day nr 1 at day 11.
Both arms receives both treatments, randomly assigned; No drug are taken for 10 days. Non-blinded. Followed by test-day nr 1 at day 11.
Both arms receives both treatments, randomly assigned
Other intervention name(s): antibiotics
Intervention MeSH terms: Anti-Bacterial Agents; Dicloxacillin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Rapid Cadence Cycling for Parkinson's Disease: A Study of Implementation and Efficacy in the Community Setting
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      Forced cadence cycling (FCC) in which individuals with Parkinson's Disease (PD) pedal with
      external augmentation at 80-90 revolutions per minute (rpm) has demonstrated significant
      motor improvement in prior clinical trials. These studies required either a tandem bicycle
      with second rider or an expensive motorized bicycle, making this therapy inaccessible to most
      patients. In this pragmatic open-label before and after pilot study investigators examine
      implementation and effectiveness of (RCC) without tandem or motor augmentation and in a
      community-based setting. Approximately 30 participants will be recruited to participate in 24
      one-hour rapid-cadence spin classes in YMCAs over 8 weeks. Primary outcomes will examine
      implementation of the intervention and secondary outcomes will examine effectiveness against
      a historical comparison group.
    


Intervention name(s): Rapid Cadence Cycling on a Solo-Rider Spin Bicycle
Intervention type(s): Other
Intervention description(s): Individuals with Parkinson's Disease will participate in 60 minute spin-classes during which they will follow the Pedaling for Parkinson's(TM) Foundation recommended protocol to achieve a cadence of 80-90 during the 40 minute main set.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
One Drop Experts Program for Type 2 Diabetes Self-Management: Impact on A1c
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The One Drop Experts Program for Type 2 Diabetes Self-Management Impact on A1c trial is a
      12-week long, prospective, intent-to-treat study that aims to evaluate the impact of the One
      Drop app and Experts program on HbA1c levels for individuals with uncontrolled Type 2
      diabetes. A secondary objective will be to evaluate participants who utilize an Apple Watch
      in combination with the One Drop app and Experts program, and assess whether this group is
      more engaged or experiences a different impact as compared to participants who utilized the
      One Drop app and Experts program only.
    


Intervention name(s): One Drop Experts Program; One Drop Experts Program + Apple Watch
Intervention type(s): Behavioral; Behavioral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Social Anxiety Disorder Study Of Paroxetine
Condition: Social Phobia
MeSH terms: Anxiety Disorders; Phobic Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to evaluate the efficacy and safety in Social Anxiety Disorder (SAD).
    


Intervention name(s): Paroxetine hydrochloride hydrate
Intervention type(s): Drug
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Anxiety; SAD; Social; Disorder