bioihbjkbjnl/mcl2 huggingface dataset:
The Effect of Vagus Nerve Stimulation on Sportive Performance.
Condition: Sports Performance
Study type: Interventional

Summary: 
      Performance is defined as the physiological potential required for an individual's physical
      activity. The sportive activity that he creates with his potential is defined as the sportive
      performance level of the individual. There are many factors that determine athletic
      performance. These factors are; environmental factors such as heredity, physical structure,
      training level, technical capacity and mental adequacy, quality of training areas,
      nutritional quality, suitability in weather conditions. All these factors affect the planning
      of multidisciplinary and interdisciplinary approaches that affect the performance of the
      athlete.

      Autonomic regulation is very important for the reorganization of the athlete's performance.
      Auricular vagus nerve stimulation (VNS) is a non-invasive method. With this method, autonomic
      nervous system regulation can be done practically. In the literature, there are no studies
      examining the effect of VNS on recovery and performance in athletes.
    

Detailed description: 
      In this study, the effects of auricular vagus nerve stimulation on performance and recovery
      were investigated, which was designed as a randomized controlled trial, a single session of
      VSU was applied to 60 male professional athletes (30 experimantal, 30 control). The normal
      application waveform was biphasic asymmetric, with a pulse duration of 300 microseconds and a
      frequency of 25 hertz, for 20 minutes and continuously.
    

Intervention name(s): Auricular vagus nerve stimulation; Sham Auricular Vagus Nerve Stimulation (AVNS)
Intervention type(s): Device; Device
Intervention description(s): Autonomic nerve system regulation; Sham Auricular Vagus Nerve Stimulation (AVNS)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Vagus, autonomic nerve system
Perillyl Alcohol in Treating Patients With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of perillyl alcohol in treating patients
      with metastatic breast cancer that has not responded to previous chemotherapy.
    

Detailed description: 
      OBJECTIVES: I. Determine the clinical effectiveness (i.e., objective tumor response, time to
      treatment failure, and survival) of perillyl alcohol in patients with previously treated
      metastatic breast cancer. II. Define the acute and chronic toxic effects of perillyl alcohol
      in this patient population.

      OUTLINE: Patients are given oral perillyl alcohol 4 times per day. Dose escalation of
      perillyl alcohol may occur in individual patients if no unacceptable toxicity is observed.
      Treatment is continued as long as the patient benefits from treatment, does not show
      progressive disease, and does not experience irreversible or life threatening toxicity.
      Patients are evaluated for response monthly while receiving treatment on this study. Patients
      are followed at 2-4 weeks after the last treatment.

      PROJECTED ACCRUAL: Approximately 40 patients will be accrued over 2 years.
    

Intervention name(s): perillyl alcohol
Intervention type(s): Drug
Intervention MeSH terms: Perillyl alcohol
Primary purpose: Treatment
Keywords: stage IV breast cancer; recurrent breast cancer
Oral Estradiol Valerate Versus Oral Contraceptive Pill in Invitro Fertilization Patients
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      The recent controversy regarding the use of pill for cycle planning in GnRH antagonists IVF
      cycle has driven the search for new ways to plan IVF cycles in order to avoid weekends or to
      equally distribute the workload. Recently, mid-late luteal phase oral estrogens seem to be as
      good as the pill. The investigators will compare OCP vs oral estrogens to plan the initiation
      of IVF cycles.
    


Intervention name(s): Levonorgestrel and ethinylestradiol; Estradiol valerate
Intervention type(s): Drug; Drug
Intervention description(s): 30 microgram of ethinylestradiol plus levonorgestrel daily for 12 to 16 days; 4mg estradiol valerate from cycle day 20 till the day before the initiation of the cycle
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Levonorgestrel; Ethinyl Estradiol; Ethinyl estradiol, levonorgestrel drug combination; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Surgery Versus Standardized Non-operative Care for the Treatment of Lumbar Disc Herniations: A Canadian Trial
Condition: Lumbar Spine Disc Herniation; Lumbar Radiculopathy
MeSH terms: Intervertebral Disc Displacement; Radiculopathy; Hernia
Study type: Interventional

Summary: 
      The objective of this study is to determine if surgery is superior to non-operative care for
      sciatica caused by a lumbar disc herniation. This study will include patients that have had
      severe sciatica for greater than 4 months which reflects the wait time of the Canadian health
      care system. This study is an opportunity to make an important contribution to medical
      science as there is no "top tier" evidence for or against this highly prevalent surgery.
      Although there have been several recent randomized trials in the field, all have been marred
      by a large number of patient crossing over from non-operative to operative treatment. Due to
      the wait for spine surgery, the Canadian system has a built-in delay that prevents such a
      cross over of patients. This study capitalizes on this unique opportunity to perform a high
      caliber surgical trial. Patients consenting to be in the study will be randomly assigned to
      expedited surgery within three weeks or standardized non-operative care while they wait on
      the surgeons list for consultation and then surgery (minimum wait of 9 months). The study
      will assess pain, function, quality of life, satisfaction, and work status to determine if
      one treatment is superior.
    


Intervention name(s): Lumbar Microdiscectomy; Physiotherapy, Epidural injections, Education, Pain Medications, Anti-inflammatories
Intervention type(s): Procedure; Other
Intervention description(s): lumbar discectomy within 1 month of randomization; Physiotherapy following standardized protocol Epidurals - Depomedrol 80 mg plus 10cc of 0.35% Lidocaine Education to occur at each visit Medications may include: NSAIDS; Acetaminophen with codeine or oxycodone or tramadol; Amitriptyline or Neurontin or Pregabalin
Intervention MeSH terms: Anti-Inflammatory Agents; Analgesics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Glucose Reduction by Early Acarbose Treatment in Basal Insulin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of acarbose in comparison
      with voglibose in type 2 diabetic patients whose blood glucose levels were inadequately
      controlled with insulin glargine alone or in combination with metformin.
    


Intervention name(s): Acarbose (Glucobay, BAYG5421); Voglibose (Basen)
Intervention type(s): Drug; Drug
Intervention description(s): uptitrated 100mg three times a day with insulin glargine alone or in combination with metformin; uptitrated 0.3mg three times a day with insulin glargine alone or in combination with metformin
Intervention MeSH terms: Acarbose; Voglibose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Oral Hypoglycemic Agent
Effect of Isotretinoin on Immune Activation Among HIV-1 Infected Subjects With Incomplete CD4+ T Cell Recovery
Condition: HIV-1 Infection
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II study was done in HIV-infected participants on antiretroviral therapy to
      evaluate the effects of isotretinoin (a drug that is approved for use in the treatment of
      severe acne) on the immune system. The immune system helps the body fight infections. When
      the immune system is not working well, one may be at greater risk for diseases that are
      common in aging, like heart disease, weaker bones, and kidney disease.
    

Detailed description: 
      Isotretinoin was administered to participants in the Isotretinoin arm at approximately 0.5
      mg/kg PO once daily for 4 weeks, then increased to approximately 1.0 mg/kg PO once daily for
      12 weeks. Follow-up continues to week 28 to evaluate the duration of effect. Randomization
      was stratified by willingness to participate in the gut biopsy substudy, A5330s. The study
      population included HIV-1 infected adults whose virus was suppressed on ART, excluding women
      of child bearing potential.
    

Intervention name(s): Isotretinoin
Intervention type(s): Drug
Intervention description(s): Isotretinoin is a drug that is approved for use in the treatment of severe acne. The aim of this study is to evaluate the role of Isotretinoin on immune activation and inflammation.
Other intervention name(s): 13-cis-retinoic acid
Intervention MeSH terms: Isotretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomized 2:1 to Isotretinoin arm and no study treatment arm. The primary endpoints were compared between the 2 study arms.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Isotretinoin; HIV-1; immunology markers; immune activation; viral suppression
NEM® + BIOCURC® Versus Placebo in Exercised-induced Joint Pain, Stiffness, & Cartilage Turnover in Healthy Men & Women
Condition: Exercise-induced Joint Pain; Exercise-induced Joint Stiffness; Exercise-induced Joint Cartilage Turnover
MeSH terms: Arthralgia
Study type: Interventional

Summary: 
      This study is intended to evaluate the combined effects of the dietary supplement NEM® brand
      eggshell membrane and BIOCURC® brand bioavailable curcumin versus placebo in reducing
      exercise-induced joint pain, stiffness & cartilage turnover in healthy men & women. Half of
      the study participants will receive NEM+BIOCURC, once daily, orally while the other half of
      the study participants will receive placebo, once daily, orally while performing an exercise
      regimen every other day for two weeks.
    

Detailed description: 
      Moderate exercise can induce discomfort in joints when done infrequently or when done too
      intensely or for too long a period. This discomfort is often realized as either pain or
      stiffness in the joint that was the focus of the exercise. For example, one's knees will hurt
      after jogging for several miles, particularly if jogging for the first time. This study is
      intended to evaluate whether the combination of NEM® brand eggshell membrane and BIOCURC®
      brand bioavailable curcumin can alleviate joint pain or stiffness, either directly following
      exercise or 12 hours post-exercise versus placebo. The study will also evaluate the
      combination's effect, on cartilage turnover via the cartilage degradation biomarker
      c-terminal cross-linked telopeptide of type II collagen (CTX-II). Participants will perform a
      minimum of 50 steps per leg utilizing an aerobics step at the clinical site. They will follow
      this exercise regimen on alternating days for 2 consecutive weeks. Changes in pain &
      stiffness (immediate & 12-hour) will be compared to both baseline and to the placebo group.
      Urine samples will also be collected at baseline and at the end of Week 1 & Week 2. The
      change in CTX-II from baseline will be compared to the placebo group.
    

Intervention name(s): NEM® + BIOCURC®; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Dietary supplement combination for the support of joint health.; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: treatment versus placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: exercise-induced; joint pain; joint stiffness; cartilage turnover; CTX-II
Effects of Blastocyst Stage Compared With Cleavage Stage Embryo Transfer in Women Below 39 Years
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Single center randomized study including 388 women aged less than 39 years, performing in
      vitro fertilization, to determine if blastocyst stage (Day 5 to 6) embryo transfer (ETs)
      improves implantation and pregnancy rate compared with cleavage stage (Day 2 to 3) ETs.
    

Detailed description: 
      Embryos from in vitro fertilization are routinely transferred into the woman's uterus at
      cleavage stage (Day 2 to 3) or at blastocyst stage (Day 5 to 6).

      The rational of blastocyst stage transfer is that blastocyst stage is the most biologically
      correct stage for embryos to be in the uterus, and longer culture in the laboratory may give
      the possibility to reduce the number of genetically abnormal embryos.

      The investigators design a single center randomized trial, including 388 women aged less than
      39 years, performing in vitro fertilization, to confront blastocyst stage embryo transfers
      (ETs) and cleavage stage ETs. Each patient is randomized with a non blind randomization,
      based on a computer model, on the first day after fertilization.

      The primary outcomes are implantation and pregnancy rate. The secondary outcome is to verify
      if blastocyst embryo transfer leads to a higher multiple-pregnancy rate.

      An interim analysis takes place at one third of the population. Follow up is of 4 weeks for
      implantation rate, and covers 8 weeks regarding pregnancy rate.
    

Intervention name(s): Embryo transfer
Intervention type(s): Procedure
Intervention description(s): Embryo transfer of maximum of 2 embryos at cleavage or blastocyst stage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Single-dose Study in Paediatric Patients Aged 2 to Less Than 18 Years With Secondary Hyperparathyroidism (sHPT) Receiving Haemodialysis
Condition: Chronic Kidney Disease, Secondary Hyperparathyroidism
MeSH terms: Neoplasm Metastasis; Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to evaluate the safety and pharmacokinetics in pediatric patients with
      secondary hyperparathyroidism receiving a single dose of etelcalcetide at the end of
      hemodialysis.
    


Intervention name(s): Etelcalcetide
Intervention type(s): Drug
Intervention description(s): A single IV-bolus dose of 0.035 mg/kg etelcalcetide into the venous line of the dialysis circuit at the end of a hemodialysis session.
Other intervention name(s): AMG 416; Parsabiv
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Secondary Hyperparathyroidism, chronic kidney disease, hemodialysis
Individualized PEEP Setting by EIT in Patients With ARDS
Condition: the PEEP Setting of ARDS
Study type: Interventional

Summary: 
      The investigators conducted a pilot study to compare the effect of Positive End Expiratory
      Pressure(PEEP) setting guide by lung electrical impedance tomography(EIT) and ARDS-net
      PEEP-FiO2 table on survival in subjects with mild/severe Acute Respiratory Distress
      Syndrome(ARDS).
    


Intervention name(s): the EIT guide the individualized PEEP Setting
Intervention type(s): Other
Intervention description(s): the EIT guide the individualized PEEP Setting in the EIT group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intravenous Lidocaine for Laparoscopic Cholecystectomy
Condition: Postoperative Pain; Opioid Consumption
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Intravenous lidocaine has been shown to have analgesic, antinflammatory, antihyperalgesic,
      antithrombotics and neuroprotective properties. In a previous study conducted in patients
      undergoing laparoscopic cholecystectomy under general anesthesia with desflurane and
      fentanyl, intraoperative i.v. infusion of lidocaine spared opioids consumption in the
      recovery room by 30%.

      The purpose of this study was to determine if an i.v. infusion of lidocaine without
      intraoperative opioids would reduce the amount of fentanyl to the same extent and
      opioids-related side effects.
    


Intervention name(s): Lidocaine; Fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): 1.5 mg/Kg as bolus and a continuous infusion of 2mg/Kg/hr until the end of surgery (closure of the skin); Fentanyl 3 mcg/Kg as bolus at the induction and a continuous infusion of normal saline (NaCl 0.9%) until the end of surgery (skin closure)
Intervention MeSH terms: Lidocaine; Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: intravenous lidocaine; postoperative pain; laparoscopic surgery; opioids; opioids side-effects
Pilot Evaluation of Youth Chef Academy
Condition: Dietary Modification; Child
Study type: Interventional

Summary: 
      This project examined the effectiveness of Youth Chef Academy (YCA), a classroom-based
      experiential culinary and nutrition literacy curriculum for middle-school students. The
      primary study hypothesis was that students assigned to YCA would demonstrate greater
      improvement in F/V and whole grain consumption compared to students in the control group.
      Eight classrooms in eight public K-8 schools participated in the project. Classrooms were
      assigned to intervention or control condition in a non-randomized manner. YCA was delivered
      by project staff to all of the students in the four intervention classrooms. Students
      completed a survey to assess primary and secondary outcomes at baseline, six-week curriculum
      completion, and at twelve-week curriculum completion (YCA extended twelve-week curriculum
      cohort).
    


Intervention name(s): Youth Chef Academy
Intervention type(s): Behavioral
Intervention description(s): Nutrition and culinary curriculum delivered in the classroom
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: School health
A Relative Bioavailability Study of Staccato Alprazolam Versus Oral Alprazolam in Healthy Study Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the relative bioavailability of alprazolam in plasma
      following a single dose of Staccato alprazolam compared to a single dose of oral alprazolam
      under fasted conditions
    


Intervention name(s): Staccato alprazolam; Oral alprazolam
Intervention type(s): Drug; Drug
Intervention description(s): Study participants will receive single dose of Staccato alprazolam by inhalation at pre-specified time points.; Study participants will receive single dose of oral alprazolam at pre-specified time points.
Other intervention name(s): UCB7538; Xanax
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy participants; Bioavailability; Phase 1; Staccato alprazolam
Impact of Short-term Fructose-enriched Diet on Serum Metabolome by Normal- and Over-weighed Women.
Condition: Non-Alcoholic Fatty Liver Disease; Obesity
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate how a high-fructose diet, either by high fructose
      intake from complex, natural foods or by fortifying the diet with corn syrup, affects the
      metabolism. Furthermore, it will be investigate if there are differences between obese and
      normal weight participants.
    


Intervention name(s): Diet
Intervention type(s): Other
Intervention description(s): 7 days fruit-rich diet, 7 days HFCS-rich diet
Other intervention name(s): C-TruSweet 01750, Cargill Deutschland GmbH, Krefeld
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Impact of a Fermented Infant Formula in Weaning Babies
Condition: Weaning
Study type: Interventional

Summary: 
      When mothers wanted to shift from breast milk to infant formulae, babies were randomly
      assigned to receive a fermented or a standard formula. Biological and clinical investigations
      were achieved at baseline (V1), and after one (V2) and three months (V3) of consumption of
      study formula. Intestinal microbiota was assessed by using culture-dependent techniques.
    


Intervention name(s): Breastmilk; Standard milk; Fermented milk
Intervention type(s): Other; Other; Other
Intervention description(s): Exclusively breastfed babies; Weaning babies fed with the standard formula; Weaning babies fed with the fermented formula
Other intervention name(s): No other names; No other names; No other names
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: weaning; breastfeeding; infant formula; fermented formula
A Single-Dose Relative Bioavailability Study Of GBT440 300 mg Capsules in Healthy Subjects
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the relative bioavailability of a single 300 mg dose
      of GBT440 administered as a high strength (1 × 300 mg) capsule versus a low strength (3 × 100
      mg) capsule formulation in healthy fasted subjects.
    


Intervention name(s): GBT440
Intervention type(s): Drug
Intervention description(s): Test: GBT440 300 mg capsule (high-strength) Reference: GBT440 100 mg capsule (low-strength)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment