bioihbjkbjnl/mcl2 huggingface dataset:
qCTG and Doppler Ultrasound in the Detection of Hypoxia Among FGR Fetuses
Condition: Late-onset Fetal Growth Restriction
MeSH terms: Fetal Growth Retardation; Hypoxia
Study type: Observational

Summary: 
      To evaluate the benefits of combining Doppler measurements of placental/fetal blood vessels
      with computerized cardiotocography (quantitative cardiotocogrpahy - qCTG) in the detection of
      fetal hypoxia (pH < 7.20) among late-onset growth restricted (SGR) fetuses
    


Intervention name(s): QDSP Protocol
Intervention type(s): Device
Intervention description(s): Computerized expert system for fetal monitoring, based on cardiotocogrpaphy
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Bulgarian population (caucasian)
Application of Telemedicine to the Management of Aggressive Lymphomas
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the value of AMA in a comparative multicenter
      regional study as a reference for aggressive lymphoma. The primary endpoint will be RDI. This
      study consider that the AMA support should allow a significant improvement of the RDI
      compared to the control group and thus impact the duration without progression. The study
      covers 350 patients recruited from 10 regional centers.
    


Intervention name(s): AMA (Assistance for ambulatory patients)
Intervention type(s): Other
Intervention description(s): telephone follow-up modality
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A 12 Week Physical Training Programme for Patients With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether water based or land based group training is
      more effective for people with COPD.
    

Detailed description: 
      COPD is a more common diagnosis today compared to 20 years ago, and the group is growing
      fast. The suffering caused by COPD and the financial cost to society is on the increasing.
      The principal causes of COPD are smoking and inactivity. So far it is poorly understood wich
      form of exercise is the most effective in training this condition.
    

Intervention name(s): Training in water; Training on land
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 45 minutes interval training in water, submaximal intensity, twice a week; 45 minutes interval training on land, submaximal intensity, twice a week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Chronic Obstructive Pulmonary Disease; COPD; Physical group training; Water exercise; Cardiorespiratory fitness; Functional exercise capacity; Health related quality of life
Physical Fitness, Exercise Capacity and Activities of Daily Living in Primary Ciliary Dyskinesia: a Retrospective Study
Condition: Primary Ciliary Dyskinesia; Kartagener Syndrome; Immotile Cilia Syndrome
MeSH terms: Ciliary Motility Disorders; Kartagener Syndrome; Dyskinesias; Syndrome
Study type: Observational

Summary: 
      Decreased pulmonary function, peripheral muscle strength, and exercise capacity were reported
      in primary ciliary dyskinesia (PCD) in recent studies. We aimed to investigate the data
      conducted between 10 July 2015 and 10 January 2015 of pulmonary function, respiratory muscle
      strength, exercise capacity, physical fitness, and activities of daily living (ADL) in PCD
      and healthy counterparts retrospectively at the first stage of the study and the effects of
      inspiratory muscle training on pulmonary function, respiratory muscle strength, and exercise
      capacity in PCD patients with decreased inspiratory muscle strength from the database
      recorded between 10 July 2015 and 10 January 2015 retrospectively at the second stage of the
      study.
    


Intervention name(s): Data Collection; Data Collection
Intervention type(s): Other; Other
Intervention description(s): The first stage of the study:
Retrospective data collection of pulmonary function, respiratory muscle strength, exercise capacity, physical fitness, and activities of daily living (ADL).
The second stage of the study
Retrospective data of pulmonary function, respiratory muscle strength, functional capacity before and after supervised inspiratory muscle training with POWERbreathe K5 device and airway clearance techniques performed for 6 weeks in PCD with decreased respiratory muscle strength (Intervention Group).
Retrospective data of pulmonary function, respiratory muscle strength, and functional capacity before and after airway clearance techniques performed for 6 weeks as home-based therapy in PCD with decreased respiratory muscle strength (Control group).; -Retrospective data collection of pulmonary function, respiratory muscle strength, exercise capacity, physical fitness, and activities of daily living (ADL)
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patient group: PCD patients consulted from Hacettepe University, Faculty of Medicine,
        Department of Pediatric Chest Diseases, Child Health and Diseases/, Ankara, Turkey to our
        unit for evaluation in terms of respiratory physiotherapy were included in our study.

        Healthy group: Healthy counterparts from our database of the previous studies were included
        in our study.
      
Keywords: Primary Ciliary Dyskinesia; Kartagener Syndrome; Immotile Cilia Syndrome; Pulmonary Function; Respiratory Muscle Strength; Exercise Capacity; Physical Fitness; Inspiratory Muscle Strength Training
Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System
Condition: Schizophrenia; Major Depressive Disorder; Bipolar I Disorder
MeSH terms: Schizophrenia; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the helpfulness of the integrated call center in optimizing use of the
      Digital Medicine System in adult subjects with Schizophrenia, Major Depressive Disorder, or
      Bipolar Disorder taking oral aripiprazole.
    

Detailed description: 
      The Digital Medicine System includes a drug-device combination of aripiprazole + an
      ingestible event marker (IEM), a wearable sensor (skin patch), and application software to
      convey the level of activity and rest, and to mark events through the act of ingestion.

      Physician and self-report are the most commonly used to assess medication compliance yet
      studies have consistently found that healthcare providers' subjective judgments of medication
      compliance are often inaccurate, with a tendency for practitioners to overestimate subject
      adherence. The sponsor's intent is to develop a system that will benefit future subjects by
      providing the ability to measure their medication-taking behavior in an objective manner and
      being able to monitor several physiologic parameters.
    

Intervention name(s): Aripiprazole + IEM (Ingestible Event Marker)
Intervention type(s): Drug
Intervention description(s): Oral aripiprazole (2, 5, 10, 15, 20, or 30 mg) with an ingestible event marker in a single daily dose for duration of the trial.
Other intervention name(s): MIND1; Digital Medicine System
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Tolerance and Safety of an Oral Nutritional Supplement (Adolescent Cohort)
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      This is an open label, non-randomized, interventional, single arm study.
    

Detailed description: 
      The primary objective is to assess whether the MAG oil-containing study formula is well
      tolerated and safe when used as an ONS in healthy adolescents.

      Hypothesis: The study product will be safe and well tolerated in healthy adolescents (as
      previously observed in adults).

      Secondary objectives:

        1. Describe the frequency and characteristics of possible gastrointestinal intolerance
           symptoms

        2. Describe stool characteristics specifically stool frequency and consistency

        3. Describe changes in anthropometric parameters, particularly weight and body mass index
           (BMI)

        4. Describe changes in blood parameters of lipid metabolism

        5. Describe changes in hematological and serum biochemistry parameters

        6. Describe daily ONS intake and overall compliance
    

Intervention name(s): MAG oil oral nutritional supplement (ONS)
Intervention type(s): Dietary Supplement
Intervention description(s): The study product is suitable for use as an oral nutritional supplement (ONS).The study product contains MAG oil.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Trial Evaluating the Role of Sildenafil in the Treatment of Fetal Growth Restriction
Condition: Fetal Growth Retardation
MeSH terms: Fetal Growth Retardation
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Randomized Controlled Trial to evaluate the effect of sildenafil on Doppler
      velocity indices of the umbilical arteries in patients with placental insufficiency and fetal
      growth restriction, and if sildenafil can improve fetal and neonatal outcomes in those
      patients.
    


Intervention name(s): Sildenafil citrate; placebo
Intervention type(s): Drug; Drug
Intervention description(s): In patients with Fetal Growth Restriction (FGR)and abnormal umbilical artery Doppler, will be randomly assigned and divided to 2 groups which will be treated with sildenafil citrate either placebo.
This study will compare the change in Resistance Index (RI) and the Pulsatility Index (PI) of the umbilical artery and fetal middle cerebral artery, for patients who receive 25 mg of oral sildenafil citrate 8 hourly starting at diagnosis of FGR until delivery against those who will receive placebo of the same color and shape of sildenafil citrate tablet.
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Sildenafil; Fetal growth Restriction; Umbilical Artery Doppler
Evaluation of Postoperative Pain After Tension-free Obturator Tape Operation (TVT-O) With or Without Local Anesthetic
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Urinary Incontinence, Stress; Pain, Postoperative
Study type: Interventional

Summary: 
      BACKGROUND:

      Compare the pain intensity after TVT-O procedure in the inner part of the thigh where the
      anesthetic substance will be injected versus the inner part of of the thigh without
      anesthetic injection in the same woman.

      The advantage of this work is that this method of testing neutralizes the effect of pain
      thresholds of different women.

      If an advantage will be found in injecting anesthetic as a reduction in postoperative pain,
      it could be recommended for all women who undergo surgery of this kind.

      METHODS:

      Preoperative women will be offered the opportunity to participate in the study after a
      detailed explanation of the study and determine a date for an elective TVT-O procedure. After
      signing the Informed Consent Form, they will undergo a TVT-O procedure with injection of
      anesthetic into one of the obturators membranes. In a random order, Marcaine 5-ml will be
      injected into a left or right obturator membrane.

      One side with Marcaine (Bupivacaine HCL) 0.5% 5 mg / mL Injection,opposite side without
      injection of any anesthetic.

      Before and after surgery, patients will receive Visual Analogue Scale (VAS) instruction and
      will be polled at the following time points: 1,6,12,24 hours after surgery per inner part of
      the thigh separately. Each patient will rate the intensity of the pain she feels on the pain
      questionnaire at each of the time points mentioned before.
    


Intervention name(s): Marcaine 0.5 % Injectable Solution
Intervention type(s): Drug
Intervention description(s): Intra -operative injection into obturator membrane
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Efficacy of Trimethoprim in Wound Healing of Patients With Epidermolysis Bullosa
Condition: Epidermolysis Bullosa
MeSH terms: Epidermolysis Bullosa
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy of trimethoprim in promoting wound
      healing and decreasing blister formation in patients with Epidermolysis Bullosa.
    

Detailed description: 
      Epidermolysis Bullosa (EB) comprises a series of hereditary disorders characterized by
      fragility of the skin and mucous membranes and the tendency of the skin to blister in
      response to minor friction or trauma. The care of patients with EB is a complex task that has
      to be carried out by a multi-professional team. In the absence of a cure, the goal of therapy
      is the prevention and healing of chronic wounds.

      In patients with EB, chronic inflammation interferes with proper wound healing. One treatment
      option is the use of anti-inflammatory antimicrobial agents, such as trimethoprim, to hasten
      wound healing and decrease blister formation. This treatment may lead to decreased pain and
      improvement of the quality of life for these patients.
    

Intervention name(s): Trimethoprim; Trimethoprim
Intervention type(s): Drug; Drug
Intervention description(s): This group will receive the active intervention (trimethoprim) first, followed by the placebo.; This group will start the study with placebo, followed by the active intervention (trimethoprim).
Intervention MeSH terms: Trimethoprim
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pediatrics; Epidermolysis Bullosa; Trimethoprim; Wound Healing
A Safety, Pharmacokinetic and Pharmacodynamic Study of ACP-001 (TransCon hGH) in Adults With Growth Hormone Deficiency
Condition: Adult Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This study investigates the safety, tolerability, pharmacokinetic profile (PK), and
      pharmacodynamic response (PD) of three different doses of ACP-001 given once-a-week compared
      to one dose-level of an approved daily human growth hormone product over a period of 4 weeks
      (4 weekly administrations versus 28 daily administrations) in adults with Growth Hormone
      Deficiency.
    


Intervention name(s): ACP-001 (TransCon hGH); ACP-001 (TransCon hGH); ACP-001 (TransCon hGH); Omnitrope
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): s.c., weekly injection; s.c., weekly injection; s.c., weekly injection; s.c., daily injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Utility of Oxygen Insufflation During Flexible Fiberoptic Bronchoscope-guided Intubation
Condition: Lumbar Spinal Stenosis
MeSH terms: Spinal Stenosis
Study type: Interventional

Summary: 
      This study investigate the utility of continuous oxygen insufflation during fiberoptic
      bronchoscope-guided intubation.

      One group receives oxygen via suction channel of fiberoptic bronchoscope during intubation.

      The other group does not receive oxygen during fiberoptic bronchoscope-guided intubation.

      Then, the velocity of deoxygenation difference of PaO2(baseline
    

Detailed description: 
      Fiberoptic bronchoscope-guided intubation is a gold standard for intubation of a patient with
      anticipating difficult airway. This technique takes several minutes without oxygen supply,
      which results in hypoxia when it prolonged. If continuous supply of oxygen during procedure
      improve the oxygenation, we can reduce the risk of hypoxemia and increase the safety margin
      during procedure.
    

Intervention name(s): Oxygen
Intervention type(s): Drug
Intervention description(s): Oxygen is supplied through suction port during bronchoscope-guided intubation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Noom Coach for Bariatric Surgery
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The prevalence of overweight in America is a national public health crisis. As more people
      consider bariatric surgery for the treatment of severe obesity, it is imperative to identify
      factors influencing surgical outcomes. Technology, particularly the Noom Coach platform,
      offers a unique opportunity to improve standard interventions utilized in bariatric surgery
      programs. This study plans to test the efficacy of the Noom Coach platform on patients'
      adherence behaviors and psychosocial factors compared to standard care.
    

Detailed description: 
      Overweight and obesity have reached epidemic proportions in the United States. Few behavioral
      treatments are effective for overweight, and bariatric surgery is consequently an
      increasingly important option. Although these procedures produce significantly more weight
      change than psychosocial treatments, post-operative weight losses vary widely, about 20% of
      patients clearly experience suboptimal weight loss, and a notable subset of these patients
      demonstrate substantial weight regain. Further, 20-30% report persistence of disturbed
      eating, depression or anxiety, or impaired health related quality of life. Adherence, or "the
      extent to which a person's behavior coincides with medical or health advice," contributes to
      variable weight and psychosocial outcomes, as well as failure to follow dietary guidelines,
      each of which negatively impacts weight loss.

      The present study, utilizing "Noom Coach for Bariatric Health", offers a unique opportunity
      to overcome obstacles to providing empirically supported treatments and to improve standard
      interventions utilized in bariatric surgery programs; however, rigorous research on apps is
      limited, and high-quality, adequately powered, randomized controlled trials with large
      samples are required. The project will therefore test a combined smartphone app and health
      coaching system to improve adherence and behavioral outcomes for patients receiving bariatric
      surgery.
    

Intervention name(s): Noom Coach for Bariatric Health
Intervention type(s): Behavioral
Intervention description(s): Noom Coach for Bariatric Health offers a sustainable, low-cost, coach-led intervention, and an innovative solution to issues with pre-bariatric surgery weight loss. The intervention will take place over 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bariatric surgery; mobile health (mHealth); psychosocial functioning; obesity; weight loss; behavioral activation
Evaluation of Apnea Tolerance in Bariatric Patients Following Rapid-sequence Induction of Anesthesia
Condition: General Surgery
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effect of the 25° head-up position versus the 55°
      head-up position on tolerable apneic time (TAT) in bariatric patients scheduled for
      laparoscopic adjustable gastric band surgery following maximum preoxygenation and
      rapid-sequence induction (RSI) of anesthesia.
    


Intervention name(s): 25° head-up position; 55° head-up position
Intervention type(s): Other; Other
Intervention description(s): Angle person is positioned for procedure.; Angle person is positioned for procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: tolerable apneic time; bariatric surgery; gastric band surgery; intubation
A Study to Monitor the Health of Participants in HIVNET 014 Who Become Infected With HIV-1
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the long-term consequences of HIV-1 infections that
      occurred in association with known, but discouraged, high-risk behaviors in persons who have
      received HIV candidate vaccines or placebo in HIVNET 014. Doctors need to look at how these
      patients respond to HIV infection in order to develop new HIV vaccines and other treatments
      for HIV and AIDS.

      Patients who receive HIV vaccines are sometimes protected from HIV infection. More often,
      these patients become HIV-positive but experience a boost in their immune system that helps
      their bodies fight HIV. Doctors need to look at how these patients respond to HIV infection
      in order to develop new HIV vaccines and other treatments for HIV and AIDS.
    

Detailed description: 
      There are many possible outcomes of HIV-1 infection among persons who receive experimental
      HIV-1 vaccines. In the best-case scenario, these vaccines may prevent infection (sterilizing
      immunity). However, current viral vaccines are thought to limit, but not prevent, virus
      replication after infection. In the latter case, it is important to document the effect of
      the immune response on the disease course as reflected by viral load, the evolution of the
      viral quasi species, and clinical symptoms over time. Understanding the evolution of the
      immune response in vaccinees after subsequent exposure and HIV infection will potentially
      result in valuable information for the subsequent design of preventive and therapeutic
      vaccines. This will be studied here using HIVNET 014 participants at higher risk for HIV-1
      infection.

      Participants discontinue HIVNET 014 vaccinations upon confirmation of HIV-1 infection and are
      enrolled in this study. Participants undergo clinical and laboratory examinations every 3
      months for the first year of follow-up and every 6 months for at least 4 years thereafter.
      Additionally, HIV-infected partners of HIVNET 014A participants undergo clinical and
      laboratory examination at enrollment, and may be asked to donate additional specimens at a
      later time. Study endpoints include various virologic, immunologic, and clinical parameters,
      such as viral load, cellular immune response, and virus phenotype and genotype.
    

Keywords: Placebos; AIDS Vaccines; Follow-Up Studies; HIV Therapeutic Vaccine