bioihbjkbjnl/mcl2 huggingface dataset:
Sleep and Stent Study: a Multicentre, Prospective Study
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      Elucidating the effects of obstructive sleep apnea (OSA) on cardiovascular outcomes is
      crucial in risk assessments and therapeutic recommendations for affected individuals. The
      Sleep and Stent Study is a multi-center observational study investigating the relationships
      between OSA and cardiovascular outcomes in patients treated with percutaneous coronary
      intervention (PCI).
    

Detailed description: 
      Preliminary data suggest that OSA may lead to adverse cardiovascular outcomes after PCI.
      However, existing data were generated from small-scale, single-center studies. Therefore, in
      the Sleep and Stent Study, the investigators aim to conduct a large-scale multi-national
      cohort study to determine the association between OSA and the incidence of adverse
      cardiovascular outcomes over a long-term follow-up period. The investigators hypothesize that
      OSA is an independent risk factor for the development of major adverse cardiovascular and
      cerebrovascular events (MACCEs) in coronary artery disease patients treated with PCI. Results
      from the Sleep and Stent Study will advance the fundamental understanding of the burden and
      prognostic implications of OSA in patients undergoing PCI for coronary artery disease.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This is a prospective, observational multi-national cohort study of patients undergoing PCI
        for coronary artery disease. Adult patients undergoing clinically indicated PCI for
        coronary artery disease will be enrolled in the Sleep and Stent Study.
      
Keywords: Sleep Apnea; Stent; Coronary Artery Disease; Percutaneous Coronary Intervention
Challenge!, a Health Promotion/ Obesity Prevention Program for Teens
Condition: Overweight
MeSH terms: Obesity; Overweight
Study type: Interventional

Summary: 
      The purpose of Challenge! is to determine if adolescents enrolled in a health promotion/
      obesity prevention program will have a healthier BMI-for-age z-score and body composition
      (body fat %), will consume a healthier diet, and engage in higher levels of physical activity
      compared to those that did not receive the intervention over time.
    

Detailed description: 
      Pediatric overweight is a major public health problem in the US, with the prevalence of
      overweight among children of all ages increasing dramatically over the past several decades.
      Interventions aimed at reducing the increased weight gain during adolescence have produced
      mixed results.

      Challenge! is a randomized controlled trial for health promotion/ obesity prevention
      targeting low-income, urban, African American adolescents. Healthy adolescents were recruited
      from an urban medical center and from local middle schools. Weight status was not part of the
      inclusion criteria.

      The intervention was home- and community-based and delivered one-on-one to each adolescent by
      a college-age "personal trainer". The intervention focused on goal-setting, consuming a
      healthy diet (increase fruits, vegetables, and water, and decrease high-fat snack and
      convenience foods), and increasing physical activity. We hypothesized that the teens enrolled
      in the intervention would have a healthier BMI-for-age z-score and a healthier body
      composition (body fat %) compared to those that did not receive the intervention over time.
      Additionally, we hypothesized that those enrolled in the intervention would consume healthier
      diets and have higher levels of physical activity compared to those that did not receive the
      intervention over time.
    

Intervention name(s): Challenge!
Intervention type(s): Behavioral
Intervention description(s): Each adolescent in the intervention group received 12 lessons administered in adolescent's home or community by a "personal trainer" (a college-aged mentor). The lessons focused on behavior change relating to diet and physical activity and was based on social cognitive theory. At the end of each lesson the adolescent set a behavior change goal for themselves. The adolescents were taught how to track their goals and they discussed thir ability/inability to meet their goals at each meeting with their personal trainer.
Other intervention name(s): Obesity prevention; Goal setting; Diet; Physical activity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: pediatric; obesity; African American; adolescents; intervention; home-based; community-based
Quadratus Lumborum Block Versus Epidural for Laparoscopic Nephrectomy Kidney Donor
Condition: Renal Transplant Donor of Left Kidney
Study type: Interventional

Summary: 
      This study aimed to compare Quadratus Lumborum Block to Epidural on Stress Response and
      Perioperative Cellular Immunological Function of Laparoscopic Nephrectomy Kidney Donor
    

Detailed description: 
      Sixty-two subjects were given informed consent before enrolling the study and randomized into
      two groups; quadratus lumborum block and epidural. Non-invasive blood pressure monitor,
      electrocardiogram (ECG), and pulse-oxymetry were set on the subjects in the operation room.
      General anesthesia induction was done by fentanyl 2 mcg/kg and propofol 1-2 mg/kg.
      Endotracheal tube (ETT) intubation was facilitated with Atracurium 0.5mg/kg as muscle
      relaxant. Maintenance was done by sevoflurane, oxygen, and compressed air. On quadratus
      lumborum block group, bilateral block using ultrasound will be performed with stimuplex 100mm
      needle with 20 cc of bupivacaine 0.25% as regimen. On epidural group, epidural catheter was
      inserted under general anaesthesia on left lateral decubitus position (5 cm depth inside the
      epidural space) at level Th10-Th11. The catheter insertion was confirmed with vacuum
      aspiration and negative test-dose. Before first incision, patient will be given continuous
      epidural Bupivacaine 0.25% 6 mL/hour. Blood sample was drawn for interleukin-6, blood
      glucose, and c-reactive protein as baseline data. After surgery, patient were extubated until
      fully conscious and can follow command verbally. Patient will be transported in recovery room
      post operation.
    

Intervention name(s): Quadratus Lumborum Block; Continuous Epidural
Intervention type(s): Procedure; Procedure
Intervention description(s): Bilateral block using ultrasound will be performed before surgery and after surgery on patient using Stimuplex 100mm needle with Bupivacaine 0.25% 0.4 mL/kg, maximum dose 25 mL each side under general anaesthesia; Patient will be given 6 mL/hour of Bupivacaine 0.25% for intraoperative analgesia and continued epidural 6 mL/hour Bupivacaine 0,125% as postoperative analgesia in 24 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: stress response; kidney donor; Cellular Imunological Function; quadratus lumborum block; numerical rating scale; morphine patient controlled analgesia
Carotid Artery Stenting With Emboli Protection Surveillance-Post-Marketing Study (CASES-PMS)
Condition: Carotid Artery Disease
MeSH terms: Carotid Artery Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to assess the outcomes of stenting with distal
      protection in the treatment of obstructive carotid artery disease during
      peri-approval/initial commercialization in relation to the outcomes of the Sapphire Clinical
      Trial. The devices to be utilized are the Cordis PRECISE Nitinol Stent Systems and the Cordis
      ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW).
    


Intervention name(s): -PRECISE Nitinol Stent System (5F, 5.5F and 6F); ANGIOGUARD™ XP Emboli Capture Guidewire (ECGW)
Intervention type(s): Device; Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety of LAIV4 in Children With Asthma
Condition: Asthma in Children; Vaccine Adverse Reaction; Vaccine Reaction; Asthma; Wheezing; Influenza
MeSH terms: Influenza, Human; Asthma; Respiratory Sounds
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective randomized, open label clinical trial in approximately 300 children
      aged 5-11 years with a physician diagnosis of persistent asthma. Participants will be
      randomized 1:1 to receive either a single intranasal dose of licensed quadrivalent LAIV
      (LAIV4) or an intramuscular injection of quadrivalent IIV4 (IIV4).
    

Detailed description: 
      The study will be conducted at three sites: Vanderbilt University Medical Center (Lead site),
      Cincinnati Children's Hospital Medical Center (contributing site), and Duke University
      Medical Center (contributing site) during the 2018-2019 influenza season. Participants will
      be randomized 1:1 to receive either a single intranasal dose of licensed quadrivalent LAIV
      (LAIV4) or an intramuscular injection of quadrivalent IIV4 (IIV4), stratifying by asthma
      severity (mild vs. moderate-to-severe). Vanderbilt will enroll about 100 participants,
      Cincinnati will enroll about 110 participants, and Duke will enroll about 90 participants.
      After enrollment, participants will be followed for 43 days via 5 additional phone, email, or
      text visits to monitor systemic reactogenicity, asthma symptoms and exacerbations, and
      serious adverse events. The primary objective is to compare proportions of participants with
      asthma exacerbations during the 42 days after LAIV4 versus IIV4. Because of the potential for
      increased risk of wheezing after LAIV, the use of LAIV in persons with asthma has been an
      area of vaccine safety research for many years; the safety issue remains unresolved. A
      clinical study to assess the safety of LAIV4 in children with asthma could expand the
      evidence base and inform clinical decision-making and public health policy.
    

Intervention name(s): Live Attenuated Influenza Vaccine (LAIV); Inactivated Influenza Vaccine (IIV)
Intervention type(s): Biological; Biological
Intervention description(s): 1 dose, 0.2 mL, intranasal administration; 1 dose, 0.5 mL, intramuscular administration
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: asthma; influenza vaccine; inactivated influenza vaccine; live attenuated influenza vaccine
Influence of Different Degrees of Renal Impairment on the Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of BIBT 986 BS in Subjects With Normal Renal Function and Patients With Different Degrees of Renal Impairment
Condition: Healthy
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the influence of different degrees of renal impairment on safety, tolerability,
      pharmacodynamics and pharmacokinetics of 1.0 mg of BIBT 986 BS given as a single dose
      infusion over 30 minutes in comparison to a normal renal function
    


Intervention name(s): BIBT 986 BS
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
3VM1001 Cream for the Treatment of Pain Associated With Post Herpetic Neuralgia (PHN)
Condition: Treatment of PHN
MeSH terms: Neuralgia; Neuralgia, Postherpetic
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Post-herpetic neuralgia (PHN) is pain following acute herpes zoster; defined as pain lasting
      longer than 3 months. Current first line management consists of tricyclic anti-depressants
      and anti-convulsants such as gabapentin and pregabalin. There is an unmet medical need for
      treatments got topical therapies that demonstrate efficacy without serious side effects.
    

Detailed description: 
      Post-herpetic neuralgia (PHN) is defined as pain following acute herpes zoster (AHZ) lasting
      >3 months. PHN develops in about 10% of patients following an episode of AHZ. 95% of adults
      ate seropositive for varicella zoster virus antibodies, and are, therefore, at risk for AHZ
      and PHN. Wider use of AHZ vaccine approved in 2006 may reduce the incidence of PHN.
      Nevertheless, PHN may be severe and frequently interferes with daily activities and with
      sleep.

      First line management of PHN pain currently is tricyclic anti-depressants and
      anti-convulsants such as gabapentin and pregabalin, and use of a 5% lidocaine patch. second
      line therapies include opioid analgesia and topical capsaicin: combinations of topical and
      systemic therapies may be used as well. These therapies have common side effects of dry
      mouth, constipation, sedation, urinary retention, nausea, somnolence, dizziness, weight gain
      and peripheral edema.

      there is an unmet medial need for topical therapies that demonstrate efficacy without the
      significant side effects o the therapies mentioned above. 3VM cream, a low concentration of
      copper in a cream vehicle may b such a therapy.
    

Intervention name(s): 3VM1001; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Self treatment 3 times daily for 10 days; Cream without investigational drug. Self treatment 3 times daily for 10 days
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Double-blind, Placebo-controlled, Crossover study to evaluate treatment and tolerability of the experimental product for treatment of post herpetic pain.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: PHN, acute, herpes zoster
Application of Two Different Synthetic Sequential Media for the Human IVF-Embryo Transfer (IVF-ET) Program
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Quality-controlled commercial media have been used in many in-vitro fertilization (IVF)
      laboratories. However, commercial media are costly and difficult to compare directly because
      their exact compositions are not clearly indicated. Although commercially available media
      have commonly been used in most IVF programs worldwide, there are several advantages to the
      use of in-house synthetic sequential media at IVF laboratories. First, the results of quality
      control should be reliable due to a stringent protocol setting-up. Second, any direct
      supplementations or deletions of specific components are feasible to obtain good quality
      embryos and high pregnancy rates since those components can be defined. Finally, dependence
      on commercially available media diminishes so that the laboratory can more easily accommodate
      unexpected situations or problems, such as a sudden increase in IVF patients. Therefore, the
      present study was conducted to compare the efficacy of in-house MRC media in the human
      IVF-embryo transfer (ET) program to that of commercially available media.
    


Intervention name(s): MRC media; Sydney IVF media
Intervention type(s): Other; Other
Intervention description(s): Culture media; Culture media
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
A Study Measuring the Effectiveness of BMS-986256 Combined With Oral Contraceptive in Healthy Female Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      A comparative study of BMS-986256 with a combined oral contraceptive in healthy female
      participants to determine the effectiveness when taken together
    


Intervention name(s): BMS-986256; Loestrin
Intervention type(s): Drug; Drug
Intervention description(s): 30 mg(6ml); 1.5 mg Norethindrone and 30ug ethinyl estradiol
Intervention MeSH terms: Norethindrone acetate, ethinyl estradiol, ferrous fumarate drug combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Evaluation of the The Neuromodulation System for the Treatment of Overactive Bladder Symptoms
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional

Summary: 
      To evaluate the efficacy and safety of non-invasive tibial nerve stimulator for the treatment
      of overactive bladder under the premise of ensuring the safety of the subjects and ensuring
      the scientific nature of the clinical trial. The primary safety endpoint will be
      device-related adverse events. The primary effectiveness endpoint will be the improvement
      value of overactive bladder symptom score (OABSS) after 12-week treatment.
    


Intervention name(s): Non-invasive low-frequency tibial nerve stimulator (TNS-01)
Intervention type(s): Device
Intervention description(s): The investigational device is a transcutaneous electrical nerve stimulation (TENS) device that is designed to provide stimulation to the nerves at the site of application via surface electrodes temporarily adhered to the skin.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Use of the Shang Ring Circumcision Device in Boys Below 18 Years Old in Kenya
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      A proof of concept study to evaluate the feasibility of using the Shang Ring, a novel male
      circumcision device across all childhood age groups namely infants (under 1), 1-5 age group,
      6-12 age group and the 13-17 age group. The study will evaluate the safety, efficacy and
      course of wound healing when using the Shang Ring technique across the four childhood age
      groups.
    

Detailed description: 
      A proof of concept study to evaluate the feasibility of using the Shang Ring, a novel male
      circumcision device across all childhood age groups namely infants (under 1), 1-5 age group,
      6-12 age group and the 13-17 age group. The study will evaluate efficacy, procedure time,
      difficulties during surgery and post-operative events shall be assessed. To evaluate safety,
      the investigators will clinically observe for adverse events during the course of healing.
      The investigators will also evaluate to length of time taken for complete healing to be
      achieved.
    

Intervention name(s): Male circumcision using the Shang Ring device
Intervention type(s): Device
Other intervention name(s): Shang ring male circumcision device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV prevention; Male Circumcision; Children; Childhood; Shang Ring
Fluvoxamine Maleate in the Treatment of Depression/Depressive State : A Post-marketing Clinical Study in Children and Adolescents
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to verify the efficacy of fluvoxamine maleate given for 8 weeks in the
      treatment of children and adolescents with depression or depressive state
    


Intervention name(s): Fluvoxamine maleate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Test product: Fluvoxamine maleate 25mg tablet. In case that the daily dose is one tablet, the study medication will orally be administered once daily, at bedtime. In case that the daily dose is two tablets or higher (maximam:6 tablets), the study mmedica; Placebo
Intervention MeSH terms: Fluvoxamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Fluvoxamine Maleate; Depression; Children and Adolescents
Clinical Study for Palliative/Preventive Treatment of Chronic Back Pain
Condition: Supplementation; Back Pain
MeSH terms: Back Pain
Study type: Interventional

Summary: 
      Randomized, controlled, double-blind, double-blind clinical trial, with three parallel arms
      depending on the product consumed (experimental product dose 1 and dose 2 and placebo
      product) and single-center, to measure the efficacy of a botanical supplement on the
      prevention of non-joint pain.
    

Detailed description: 
      Subjects who meet the selection criteria will be randomly assigned to each of the study
      groups (investigational product dose 1 or dose 2, or placebo, depending on the group to which
      they have been assigned).

      The product to be consumed is a Botanical Extract. Participants will consume the product for
      84 days. It should be taken half an hour before breakfast, two capsules per day.

      The study subjects will have to make 5 visits to the laboratory. On the first and last visit,
      they will have their blood drawn, their sleep quality will be evaluated and they will
      complete a series of questionnaires to evaluate their quality of life and type of back pain.
      In the rest of the visits they will only have to take the tests on paper.
    

Intervention name(s): Experimental product; Control product consumption
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Botanical extract; Product with identical characteristics to the experimental product.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: botanical extracts