bioihbjkbjnl/mcl2 huggingface dataset:
Bariatric Surgery and Sperm Quality
Condition: Obesity; Bariatric Surgery
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the impact of a bariatric surgery (gastric banding,
      bypass, sleeve gastrectomy) on several parameters (quality of sperm and others biological
      parameters, lifestyle, quality of life) involved in fertility of obese adult men.
    

Detailed description: 
      In order to assess how bariatric surgery may influence their fertility parameters, patients
      will attend to 3 visits :

      First visit (inclusion, before surgery) :

        -  Signature of consent

        -  Patient interview (Collection of data on background, treatments, socio-demographic
           characteristics, social and familial environment, food consumption and habits, tobacco
           and alcohol use, physical activity, libido and quality of life (surveys))

        -  Clinical examination and anthropometric assessment (BMI, blood pressure, expired CO)

        -  Blood samples (Metabolic and nutritional plasmatic biomarkers ; Plasmatic oxidative
           stress biomarkers ; antioxidants micronutrients ; hormones of adiposity and inflammation
           ; sex hormones ; persistent contaminants)

        -  Sperm sample (sperm count-morphology ; DNA fragmentation ; CASA)

      Bariatric surgery

      Second visit (6 month follow-up)

        -  Report of adverse events if any

        -  Surveys

        -  Blood and sperm samples

      Third visit (12 month follow-up)

        -  Report of adverse events if any

        -  Blood and sperm samples
    

Intervention name(s): Blood and sperm samples
Intervention type(s): Other
Intervention description(s): Blood and sperm samples will be done in each visit
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Obesity; Bariatric surgery; Sperm quality; Fertility
Application of Ultrasound-Guided Thoracic Paravertebral Block in Pulmonary Ablation Surgery
Condition: Lung Cancer
Study type: Interventional

Summary: 
      Local thermal ablation therapy of tumor is a rapidly developing minimally invasive therapy
      for lung tumors in recent years. This study evaluated the efficacy of thoracic paravertebral
      block (TPVB) for anaesthesia during ablation surgery of lung tumor.
    

Detailed description: 
      Lung cancer is a serious threat to human health and life. Local thermal ablation therapy of
      tumor is the focus of domestic and overseas research in the past decade.Thoracic
      paravertebral nerve block (TPVB) is the technique of injecting local anaesthetic in the
      paravertebral space to anesthetizes the spinal nerve roots and sympathetic chain，which will
      produces ipsilateral and somatic blockade.The present study was designed to evaluate the
      analgesic effect and safety of TPVB in the ablation surgery of lung tumor.

      After obtaining approval from the Hospital Ethics Committee and informed written consent from
      the patients,30 adult patients scheduled for Local thermal ablation therapy of lung tumours
      were recruited. Patients were excluded if they had a history of psychiatric illness, chronic
      pain, regular analgesic usage or there were contraindications to performing a TPVB, such as
      chest wall deformity, severe coagulopathy, local infection and allergy to local anaesthetic
      drugs. The study lasted a total of six months.

      During the preoperative visit, all patients received the explanation of overall research
      approach.After entering the CT fluoroscopy room, peripheral veins and routine monitoring that
      included electrocardiography, pulse oximetry, and noninvasive arterial blood pressure were
      obtained in all patients.Thoracic paravertebral block was performed 20 minutes before the
      Local thermal ablation therapy began.The degree of pain was assessed using VAS score; at
      performing TPVB，the beginning of surgery， 6 and 24 hours after ablation surgery.Dezocine will
      be given as remedial analgesia.Following the operation, transferred the patients to the
      observation area where the vital signs were monitored for 30 min.Assessing and record the
      degree of patients and surgeons satisfaction for anesthetic management.
    

Intervention name(s): Ropivacaine
Intervention type(s): Other
Intervention description(s): Thoracic paravertebral block(TPVB) is performed on the patients who undergo the thermal ablation therapy.
Intervention MeSH terms: Ropivacaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Patient Satisfaction With Contoura Vision Topography-Guided LASIK
Condition: Myopia; Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      To evaluate patient reported outcomes associated with quality of vision before and after
      treatment with Contoura Vision Topography-Guided LASIK.
    


Intervention name(s): Contoura Vision LASIK
Intervention type(s): Procedure
Intervention description(s): Topography-Guided LASIK using Phorcides Analytic Software
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ultrasound Guided Axillary Venous Cannulation in Pediatrics
Condition: Ultrasound Guided Central Venous Cannulation
Study type: Interventional

Summary: 
      The purpose of this prospective randomized study was to compare landmark-subclavian venous
      access to ultrasound-guided axillary venous access when performed by pediatric
      anesthesiologists.
    

Detailed description: 
      Objective: Subclavian vein catheterization may cause various complications. The investigators
      will compare the real-time ultrasound-guided axillary venous access vs. the landmark method-
      subclavian venous access in pediatric paticipants. (the needle insertion point of
      ultrasound-guided axillary venous is axillary vein. and the needle insertion point of
      landmark method is infraclavicular subclavian vein)

      Design: Prospective randomized study.

      Setting: Operating room of a tertiary medical center.

      Interventions: The investigators will compare the ultrasound-guided axillary vein cannulation
      (66 paticipants) vs. the landmark method (66 pa- ticipants).
    

Intervention name(s): landmark; US_Ax
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Buffered Local Anesthetic
Condition: Dental Pain
MeSH terms: Toothache
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to compare responses in children during dental
      injections of local anesthetic (used for numbing), while children are under deep sedation
      (breathing on their own, often with a loss of consciousness). Two types of local anesthetic
      will be used--one will be buffered (by adding a salt solution to make it less acidic), while
      the other will be plain, without anything added. Previous studies have shown that the
      addition of the buffer solution can improve comfort during a dental injection.
    


Intervention name(s): Non-buffered Anesthetic; Buffered Anesthetic; Onset
Intervention type(s): Drug; Drug; Device
Intervention description(s): non-buffered LA, 2% lidocaine with epinephrine 1:100,000; A cartridge of 2% lidocaine with epinephrine 1:100,000 alkalinized at 9:1 ratio with a resulting pH of 7.21 using 8.4% sodium bicarbonate solution per manufacturer.; The test solution will be made by a mixing pen called "Onset"- This mixing pen Onset will deliver 0.18 mL of sodium bicarbonate solution into the anesthetic cartridge.
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Dental surgery; Deep sedation
Management of Skin and Soft Tissue Abscesses in Pediatric Patients After Incision and Drainage
Condition: Abscess
MeSH terms: Abscess
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to compare rates of cure of abscesses with and without antibiotic
      treatment after incision and drainage. The purpose of this study is to compare successful
      rates of cure of abscesses less than 5 cm with antibiotic (oral TMP/SMX) versus
      non-antibiotic treatment after incision and drainage.
    

Detailed description: 
      This study is a randomized controlled trial of antibiotic treatment versus placebo after
      incision and drainage of skin and soft tissue abscesses less than 5 cm in pediatric patients.
      Eligible patients whose parents/guardians consented them to enrollment were randomized to
      receive one of two interventions: oral trimethoprim/sulfamethoxazole (TMP/SMX) or placebo
      after incision and drainage. Every attempt was made to make the placebo capsules and
      suspensions appear in all aspects like the true drug (was done by the investigational
      pharmacy department at our institution). Equal numbers of subjects were randomized at the
      outset to both study groups. Randomization, also done by our investigational pharmacy
      department, was done in blocks of 20. Patients were followed up in our emergency center at 24
      to 48 hours to have any packing removed and to have their clinical/wound status assessed.
      They were not charged for this visit, and their valet parking was validated. If an individual
      patient, or an individual patient's wound, was felt to be not improving adequately, that
      patient was started on formal antibiotic therapy at the treating attending physician's
      discretion.

      Primary outcome:

      1. Abscess resolution by parental report 7-10 days after incision and drainage

      Secondary outcomes:

        1. Admission to the hospital because of worsening infection

        2. Receipt of antibiotics (placebo arm) or change in antibiotics (antibiotic arm)
    

Intervention name(s): oral trimethoprim/sulfamethoxazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 80 mg caps or 8 mg/ml suspension every 12 hours for 10 days; Placebo caps or suspension every 12 hours for 10 days
Other intervention name(s): TMP/SMX; Placebo caps
Intervention MeSH terms: Trimethoprim; Sulfamethoxazole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: abscess; Abscesses in the pediatric emergency population
A Parallel Study Evaluating the Effect of A-F Betafood® on Gallbladder and Liver Function.
Condition: Gallbladder
Study type: Interventional
Phase: Phase 2

Summary: 
      Gallstone formation is multifactorial: immutable risk factors include genetics and ethnicity,
      age and being female, and mutable risk factors include obesity, and metabolic syndrome, diet,
      rapid weight loss, and other conditions such as cirrhosis, Crohn's disease, irritable bowel
      syndrome, gallbladder stasis, and the use of certain drugs like Ceftriazone. Previous studies
      have linked serum cholesterol, and low-density lipoprotein cholesterol levels and fatty liver
      disease to gallbladder disease. Given betaine's reported beneficial effects on fatty liver
      and lipid profile, A-F Betafood® may have a beneficial effect on gallbladder function.

      The objective of the study is to assess the effect of A-F Betafood® on gallbladder and liver
      function as measured by gallbladder ultrasounds and liver function tests. The hypothesis is
      that A-F Betafood® will improve gallbladder and liver function after the 12 week treatment
      period.

      This is a single-center, randomized, double-blind, placebo-controlled, parallel group study
      with two arms. This study will consist of a single 12 week treatment period. The planned
      sample size for this study is 50 overweight female subjects, with 25 subjects randomized
      equally to each of the two study arms in double-blind manner at a ratio of 1:1
    


Intervention name(s): A-F Betafood; Placebo
Intervention type(s): Dietary Supplement; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Gallbladder motility; A-F Betafood; Betaine; Ejection fraction; Ejection rate; Ultrasound
Study of the Efficacy and Safety of MEDI4893
Condition: Staphylococcus Aureus Pneumonia
MeSH terms: Pneumonia, Staphylococcal
Study type: Interventional
Phase: Phase 2

Summary: 
      Clinical trial looking at safety and efficacy of MEDI4893 in prevention of pneumonia caused
      by Staphylococcus aureus in high-risk patients
    


Intervention name(s): MEDI4893; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Participants will receive a single IV dose of MEDI4893 2000 or 5000 mg on Day 1 of the study.; Participants will receive a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Safety, Immunogenicity of RTS,S/AS02A, and RTS,S/AS01B Malaria Vaccines in Malaria-experienced Adults.
Condition: Plasmodium Falciparum
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      The candidate malaria vaccine RTS,S/AS02A developed by GSK Biologicals demonstrated 30%
      efficacy against clinical episodes of malaria and approximately 58% efficacy against severe
      malaria disease. As a potential improvement to RTS,S/AS02A, another candidate vaccine
      RTS,S/AS01B is being developed in parallel in collaboration with the Walter Reed Army
      Institute of Research (WRAIR). This study will be the first administration of the RTS,S/AS01B
      vaccine to the African adults to establish safety and immunogenicity in this population.
      Preliminary indication of vaccine efficacy with this adjuvant will be established by
      monitoring the time to the first infection with Plasmodium falciparum.
    

Detailed description: 
      The study comprises of 3 groups and the participating subjects will be randomly allocated to
      one of the three groups. The first group will receive RTS,S/AS01B, the second group will
      receive RTS,S/AS02A and the third group will receive rabies vaccine. Immunization will be
      given by IM injection on 0, 1, 2 month schedule. Infants will be followed up daily for 7 days
      for solicited symptoms and 30 days for unsolicited symptoms after each vaccine dose. Serious
      adverse events will be recorded throughout the study period. A week prior to Dose 3, subjects
      will be treated with a licenced anti-malarial drug. Starting from two weeks after Dose 3, the
      subjects will be monitored for a 14-week duration for detection of malaria infection.
    

Intervention name(s): RTS, S/AS01B; RTS, S/AS02A; Rabipur (Rabies) Vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and liposomes in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.; 0.5mL dose; 50ug RTS, S antigen, 50ug QS21 and proprietary oil-water emulsion in phosphate-buffered saline administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months.; 1.0mL dose administered intramuscular deltoid of non-dominant arm at 0, 1 and 2 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Replication of the VERO Osteoporosis Trial in Healthcare Claims Data
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Observational

Summary: 
      Investigators are building an empirical evidence base for real world data through large-scale
      replication of randomized controlled trials. The investigators' goal is to understand for
      what types of clinical questions real world data analyses can be conducted with confidence
      and how to implement such studies.
    

Detailed description: 
      This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE
      initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical
      School. It is intended to replicate, as closely as is possible in healthcare insurance claims
      data, the trial listed below/above. Although many features of the trial cannot be directly
      replicated in healthcare claims, key design features, including outcomes, exposures, and
      inclusion/exclusion criteria, were selected to proxy those features from the trial.
      Randomization is also not replicable in healthcare claims data but was proxied through a
      statistical balancing of measured covariates according to standard practice. Investigators
      assume that the RCT provides the reference standard treatment effect estimate and that
      failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims
      data for replication for a range of possible reasons and does not provide information on the
      validity of the original RCT finding.
    

Intervention name(s): Teriparatide; Risedronate
Intervention type(s): Drug; Drug
Intervention description(s): Teriparatide dispensing claim is used as the reference group.; Risedronate dispensing claim is used as the exposure group.
Intervention MeSH terms: Teriparatide; Risedronic Acid
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study will involve a new-user, multicenter, propensity score-matched, retrospective
        cohort study design comparing teriparatide and risedronate in post-menopausal women.
A Comparison Study of Three Standard Elbow Wrist Hand Orthoses to Limit Forearm Rotation
Condition: Healthy
Study type: Interventional

Summary: 
      The Researchers are trying to assess which splint limits forearm rotation the best. These
      splints are commonly used in hand therapy to limit forearm rotation. This data will help hand
      surgery and hand therapy provide better outcomes.
    

Detailed description: 
      Common upper extremity injuries often need to heal with no wrist and forearm range of motion.
      Forearm range of motion includes supination and pronation. Injuries that necessitate limiting
      forearm range of motion include fracture patterns involving the distal radioulnar joint
      (DRUJ), proximal radioulnar joint (PRUJ), triangular fibrocartilage complex (TFCC), both bone
      forearm fractures, ulnar shortening procedures, radial and ulnar osteotomies, DRUJ
      instability. Long arm orthoses, sugar tong orthoses and muenster style orthoses can all limit
      forearm rotation.

      Past research has indicated common methods of immobilization to include the following: sugar
      tongs cast/orthosis, muenster cast/orthosis, long arm cast/orthosis/or short arm
      cast/orthosis, and an antirotation orthosis.

      Currently, there are no research studies that compare the amount of forearm rotation in a
      traditional thermoplastic orthoses to newer materials such as a Delta Cast orthosis, or
      prefabricated muenster orthoses such as the Hely and Weber MTC Fracture Brace. The purpose of
      this study is to assess which orthosis-a traditional thermoplastic ulnar based muenster, a
      delta cast style muenster and the Hely and Weber MTC Fracture Brace-allows for the least
      amount of supination and pronation in a healthy population in the dominant extremity.

      The researchers will assess the 3 different orthoses using a standard measuring device for
      pronation and supination. The participants will also be asked questions regarding comfort,
      fit, and style of each orthosis. 30 Participants data will be collected during the study.
    

Intervention name(s): Hely & Weber MTC Fracture Brace; Thermoplastic orthosis; Delta cast orthosis
Intervention type(s): Device; Device; Device
Intervention description(s): Prefabricated muenster orthosis; Muenster orthosis fabricated out of thermoplastics and secured with Velcro; Muenster orthosis fabricated out of Delta Cast and secured with Velcro
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Assess the Safety and Immunogenicity of the Malaria Vaccine, R21, Administered With and Without Matrix-M1
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a clinical trial in which healthy volunteers will be administered one or two
      experimental malaria vaccines. The vaccine R21 will either be administered alone or in
      combination with the adjuvant vaccine Matrix-M1.

      All vaccinations will be administered intramuscularly. Each volunteer will receive three
      vaccinations in total.

      There are three different vaccine schedules:

      Group 1 will receive 10µg of R21 mixed with 50µg of Matrix-M1 on days 0, 28, and 56.

      Group 2 will receive 50µg of R21 on days 0, 28, and 56. .

      Group 3 will receive 50µg of R21 mixed with 50µg of Matrix-M1 on days 0, 28, and 56.

      The study will assess the safety of the vaccines, and the immune responses to the
      vaccinations. Immune responses are measured by tests on blood samples.

      Healthy adult volunteers will be recruited in Oxford and London, England.
    


Intervention name(s): R21; Matrix-M1
Intervention type(s): Biological; Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Improvement of Quality of Life in Patients Using Low-dose Pills in the Different Phases of Menacme
Condition: Quality of Life; Menopause; Contraception
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether low-dose contraceptive pills are effective
      in the improvement of quality of life in patients in the different phases of menacme.
    


Intervention name(s): gestoden 60 mcg; ethinylestradiol 15 mcg
Intervention type(s): Drug; Drug
Intervention description(s): gestoden 60 mcg, once a day, administered in 24/4 regimen.; ethinylestradiol 15 mcg, once a day, administered in 24/4 regimen
Other intervention name(s): oral contraceptives; quality of life; gestodene and ethinyl estradiol; gestodene and ethinyl estradiol; quality of life; oral contraceptives
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Gestodene; Femovan; Contraceptive Agents; Contraceptives, Oral; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Quality of life; Menopause; Contraception