bioihbjkbjnl/mcl2 huggingface dataset:
Does Improving Vagal Tone Increase Mitochondrial Bioenergetics
Condition: Functional Gastrointestinal Disorders; Irritable Bowel Syndrome; Dyspepsia; Functional Abdominal Pain Syndrome
MeSH terms: Irritable Bowel Syndrome; Gastrointestinal Diseases; Digestive System Diseases; Syndrome; Dyspepsia; Abdominal Pain
Study type: Interventional

Summary: 
      This study evaluates the effect of auricular neurostimulation on mitochondrial bioenergetics
      and inflammation through vagal nerve modulation via non-invasive percutaneous electrical
      nerve field stimulator in children with functional gastrointestinal disorders.
    

Detailed description: 
      In understanding the pathophysiology of pediatric functional gastrointestinal disorders
      (FGID), it has been documented that subjects have decreased vagal tone. Vagal tone in turn
      modulates mitochondrial bioenergetics and plays a role in anti inflammatory effects. Further
      defining these brain-body connections that underlie FGID's could help guide future treatment.

      The investigators postulate that a 4 week neuro-stimulation with an Electro Auricular Device
      that has already shown to increase vagal tone will produce an increase in mitochondrial
      bioenergetics and decrease in inflammatory markers in this patient group.
    

Intervention name(s): Percutaneous neurostimulation
Intervention type(s): Device
Intervention description(s): Percutaneous neurostimulation using NSS-2 Bridge device
Other intervention name(s): NSS-2 Bridge by Innovative Health Solutions
Intervention model: Single Group Assignment
Intervention model description: All subjects will receive the same electro auricular device
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: FGID; Neural Stimulation; Functional Abdominal Pain; Dysautonomia
Effectiveness and Tolerability of Phentermine in Patients Under Bariatric Surgery
Condition: Obesity; Morbid Obesity; Bariatric Surgery; Non-alcoholic Fatty Liver; Weight Loss
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Obesity; Obesity, Morbid; Weight Loss
Study type: Interventional
Phase: Phase 4

Summary: 
      Surgical management of Morbid Obesity is increasingly frequent. A low-calorie diet is
      recommended with the main goal of reducing intrahepatic fat infiltration, fat tissue and
      making easier the surgery. Information the use pharmacological interventions during the
      preoperative period in this population are rare.
    

Detailed description: 
      This is a randomized, control trial to investigate the effect and safety of Phentermine in
      patients with obesity who need a bariatric surgery (BMI >35 kg/m2 with comorbidities or BMI >
      40 kg/m2).

      Screening will be made to select eligible participants before intervention. Participants were
      randomly assigned to one of two groups (low-calorie diet + phentermine 15 mg or low-calorie
      diet + placebo) for therapies during 6 weeks. Anthropometric measurements (weight, body
      composition, body mass index and waist-hip index), serum metabolic profile (glucose, total
      cholesterol, HDL-c, LDL-c, triglycerides, and HOMA-IR) markers of inflammation (IL-1, IL-6
      and PCR) and hepatic ultrasound will be measured 2 times for each participant. Surgical
      complications (anastomosis filtration, intestinal obstruction or stenosis, need to perform
      open surgery and mortality) will be evaluated. Adverse events associated with phentermine
      (blood pressure, cardiac frequency, headache, gastrointestinal symptoms, euphoria, anxiety
      and insomnia) will be collected.
    

Intervention name(s): Phentermine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): This is a randomized, control trial to investigate the effect and safety of Phentermine in patients with obesity who need a bariatric surgery (BMI >35 kg/m2 with comorbidities or BMI > 40 kg/m2).; his is a randomized, control trial to investigate the effect and safety of Phentermine in patients with obesity who need a bariatric surgery (BMI >35 kg/m2 with comorbidities or BMI > 40 kg/m2).
Other intervention name(s): Terfamex
Intervention MeSH terms: Phentermine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental, analytic, comparative, prospective, longitudinal and double-blinded study.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Obesity treatment; Non-alcoholic Fatty Liver; Weight Loss
A Phase 1/2 Open-Label Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Intracerebroventricular BMN 190 in Patients With Late-Infantile Neuronal Ceroid Lipofuscinosis (CLN2) Disease
Condition: Jansky-Bielschowsky Disease; Batten Disease; Late-Infantile Neuronal Ceroid Lipofuscinosis Type 2; CLN2 Disease
MeSH terms: Neuronal Ceroid-Lipofuscinoses
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether BMN 190 is safe and effective in the
      treatment of patients with Late-Infantile Neuronal Ceroid Lipofuscinosis Type 2 (CLN2)
      disease.
    

Detailed description: 
      The purpose of this study is to determine whether BMN 190 is safe and effective in the
      treatment of patients with Late-Infantile Neuronal Ceroid Lipofuscinosis Type 2 (CLN2)
      disease. This is an open label Phase 1/2 study conducted in patients with CLN2 disease.
      Efficacy measures (disease rating scale and MRI) will be compared to a natural history
      control.

      The study will be conducted under cGCP and patients will be closely monitored.
    

Intervention name(s): BMN 190
Intervention type(s): Biological
Intervention description(s): 30-300 mg ICV infusion administered every other week for at least 48 weeks.
Other intervention name(s): recombinant human tripeptidyl peptidase-1 (rhTPP1); cerliponase alfa
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Late infantile Neuronal Ceroid Lipofuscinosis Type 2; LINCL; NCL2; CLN2; Jansky-Bielschowsky disease
Effect of the Cognitive Strategy During Trunk Muscle Endurance in Patients With Lumbar Hernia Surgery
Condition: Low Back Pain; Disk Herniated Lumbar
MeSH terms: Low Back Pain
Study type: Interventional

Summary: 
      Muscle endurance will be evaluated on two exercises: Biering-Sorensen Test and Prone Plank
      Test. Each test will be assessed in different days following a randomized order.
    

Detailed description: 
      All patients will be encouraged to achieve the maximum time to task failure, stopped only by
      muscular fatigue or pain precluding to maintain the position. Each exercise will perform
      under two conditions.

      On the control condition, the patients will perform both tests without any cognitive
      condition, while on the experimental condition they will be instructed to perform both tests
      while performing a mathematical subtracting task (starting at 300, by sevens).

      The starting condition will be randomly assigned with a 5-minute rest prior to the next
      condition. Time to task failure and pain perception using a visual analog scale will be
      assessed.
    

Intervention name(s): Biering-Sorensen Test and Prone Plank Test
Intervention type(s): Diagnostic Test
Intervention description(s): All patients will be encouraged to achieve the maximum time to task failure, stopped only by muscular fatigue or pain precluding to maintain the position.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Each test will be assessed in different days following a randomized order.
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Muscle endurance; Biering-Sorensen Test; Prone Plank Test.; Dual task; time to failure
Safety, Tolerability and Pharmacokinetics of QAK423A in Healthy Volunteers and Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      There are three elements to this study:

        -  Part A: Single dose escalation in healthy subjects. 6 dose levels of QAK423 are planned
           in healthy volunteers.

        -  Part B: Single dose escalation in patients with mild/moderate COPD. 3 dose levels of
           QAK423 are planned in COPD patients.

        -  Part C: Titrated repeat dosing for a maximum of 14 days in mild/moderate COPD patients.

      Repeat dosing is planned in COPD patients.
    


Intervention name(s): QAK423A; QAK423A; QAK423A
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chronic obstructive pulmonary disease
ACD440 Gel in Peripheral Neuropathic Pain
Condition: Peripheral Neuropathic Pain
MeSH terms: Neuralgia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-blind, randomized, placebo-controlled crossover outpatient study in patients
      with peripheral neuropathic pain with allodynia or hyperalgesia to cold, heat, brush and/ or
      pinprick stimulation. Patients will in random order receive ACD440 Gel or placebo treatment
      twice daily for 7 days, topically applied to the painful area. This is followed by a 2-week
      washout period, then receive the alternate treatment.
    


Intervention name(s): ACD440 Gel 14mg/g; Placebo Gel
Intervention type(s): Drug; Drug
Intervention description(s): Topical application to painful area; Topical application to painful area
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Risk Factors for Recurrence After Pelvic Reconstruction
Condition: Pelvic Organ Prolapse
MeSH terms: Recurrence; Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      232 women underwent transvaginal mesh repair (TVM)with /without transvaginal hysterectomy for
      symptomatic POP, including group A（accepted herniamesh polypropylene mesh， 117
      patients)；group B （underwent biological graft of cook，115 patients)；follow-ups for six months
      and one year after the surgery and a questionnaire about the life habits associated with
      relapse.
    

Detailed description: 
      We prospectively study a total of 232 women who underwent transvaginal mesh repair (TVM)with
      /without transvaginal hysterectomy for symptomatic POP, the patients into two groups :group A
      was accepted herniamesh polypropylene mesh(117)；group B underwent biological graft of
      cook(115)；Each patient underwent an interview that included a POP-Q which was quantified
      according to the Pelvic Organ Prolapse Quantitation (POPQ) system;follow-ups for six months
      and one year after the surgery and a questionnaire about the life habits associated with
      relapse.
    

Intervention name(s): herniamesh; biological graft
Intervention type(s): Device; Device
Intervention description(s): Patients were randomly assigned in a ratio of 1:1,by using SPSS19.0 statistical software, to either trocar-guided transvaginal mesh(herniamesh, group A) or biological graft (cook, group B)repair.; Patients were randomly assigned in a ratio of 1:1,by using SPSS19.0 statistical software, to either trocar-guided transvaginal mesh(herniamesh, group A) or biological graft (cook, group B)repair.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: Pelvic organ prolapse; Vaginal mesh; biological graft; Recurrence
Changes in Muscle Morphology Resulting From Anterior Cruciate Ligament Reconstruction
Condition: Isolated Anterior Cruciate Ligament Rupture
MeSH terms: Rupture
Study type: Interventional

Summary: 
      The aim of this study is to gain new knowledge on the impact of hamstring tendon harvest and
      apply that knowledge to the treatment and management of patients who undergo anterior
      cruciate ligament (ACL) reconstruction. There are three main components of this study:

        1. How do muscle shape, size, strength, and ability to function change following hamstring
           grafting for ACL reconstruction;

        2. How does physical activity change following ACL reconstruction;

        3. Is there a difference in outcome if graft harvest is done from the injured versus
           uninjured limbs
    


Intervention name(s): Autograft STG harvest from ACL-deficient leg; Autograft harvest contralateral to ACL-deficient leg
Intervention type(s): Other; Other
Intervention description(s): Semitendinosus-gracilis graft harvest is undertaken on same limb that is undergoing ACL reconstruction; Semitendinosus-gracilis graft harvest is undertaken on limb contralateral to that undergoing ACL reconstruction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: anterior cruciate ligament; hamstring; semitendinosus; gracilis; graft
Sun Protection Factor Assay
Condition: Sunscreening Agent
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): Coppertone (BAY987516)
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Number- SR15-60-Z15-030).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Paclitaxel and Carboplatin in Treating Patients With Persistent or Recurrent Stage III or Stage IV Uterine Cancer
Condition: Sarcoma
MeSH terms: Sarcoma; Carcinosarcoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving paclitaxel together with carboplatin
      works in treating patients with persistent or recurrent stage III or stage IV uterine cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the antitumor activity of paclitaxel and carboplatin in patients with
           persistent or recurrent stage III or IV uterine carcinosarcoma.

        -  Determine the nature and degree of toxicity of this regimen in these patients.

      OUTLINE: This is a non-randomized, multicenter study.

      Patients receive paclitaxel IV over 3 hours followed by carboplatin IV over 30 minutes on day
      1. Courses repeat every 21 days in the absence of disease progression or unacceptable
      toxicity.

      After completion of study treatment, patients are followed every 3 months for 2 years and
      then every 6 months for 3 years.

      PROJECTED ACCRUAL: Approximately 14-47 patients will be accrued for this study within 20
      months.
    

Intervention name(s): carboplatin; paclitaxel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Paclitaxel; Carboplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent uterine sarcoma; stage III uterine sarcoma; stage IV uterine sarcoma; uterine carcinosarcoma
Comparison of Drug Eluting Balloon and Drug Eluting Stent
Condition: Coronary Artery Disease; Stable Angina; Unstable Angina; NSTEMI
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Angina Pectoris; Angina, Stable; Angina, Unstable
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of Drug-Eluting Balloon
      first and then bare metal stent compared with drug-eluting stent for treatment of de novo
      lesions (DEB first).
    

Detailed description: 
      A recent trial to test premount bare metal stent on drug-eluting balloon failed to
      demonstrate non-inferiority and safety compared to drug-eluting stent alone for treatment of
      coronary artery stenosis.

      We think that inappropriate drug delivery to diseased vessel due to stent strut might affect
      the efficacy of drug-eluting balloon. Therefore, we design a clinical study with a different
      protocol, that is, drug-eluting balloon first and then bare metal stent implantation in
      comparison to drug-eluting stent.
    

Intervention name(s): Drug eluting balloon + Bare metal stent; drug eluting stent (Zotarolimus-eluting stent)
Intervention type(s): Device; Device
Intervention description(s): PCI using Sequent Please and then Coroflex Blue; conventional PCI using Endeavor Integrity
Other intervention name(s): Sequent Please (B.Braun, drug eluting balloon); Coroflex Blue (B.Braun, bare metal stent); Endeavor integrity; Zotarolimus-eluting stent
Intervention MeSH terms: Sirolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: drug eluting balloon; bare metal stent; drug eluting stent; coronary artery disease
Systemic, Intrapulmonary and Pleural Inflammatory Reaction in Patients Undergoing Thoracic Surgery
Condition: Lung Neoplasms
MeSH terms: Lung Neoplasms; Inflammation
Study type: Observational

Summary: 
      Inflammatory reaction in different compartments of the body may have a negative effect on
      outcome. This study assesses the inflammatory reaction systemically, intrapulmonary and
      intrapleural by measuring different cytokines. Patients with lung cancer undergoing lobectomy
      or segmentectomy are included in the study. Hypothesis: The inflammatory reaction in the
      pleural space is high compared to the systemic and intrapulmonary ones.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        all patients undergoing lobectomy or segmentectomy for lung cancer at a single institution
      
Keywords: lobectomy; inflammatory reaction; intrapulmonary; intrapleural
hUC Mesenchymal Stem Cells (19#iSCLife®-CSD) Therapy for Patients With Healing Poor After Uterus Injury
Condition: Uterus; Injury
MeSH terms: Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is verify the efficacy and safety of Human Umbilical Cord
      Mesenchymal Stem Cells (UC-MSC) therapy for patients with Healing Poor after Uterus Injury,
      and exploring the possible mechanisms of umbilical cord mesenchymal stem cell therapy in
      Healing Poor After Uterus Injury disease
    

Detailed description: 
      This is a random, open label, and self-control experiment. 10 patients are selected and sign
      consent forms, then divided into one group. Doctors collect the basic information of patient
      (including age,height, mental condition, vital sign, history of disease, pharmaco-history,
      and so on.), evaluate the symptom of healing Poor after Uterus Injury (Menstrual conditions,
      Visual analogue scale, pregnancies).

      All patients receive laboratory and image examination as baseline. Then, cell treatment will
      be given based on the clinical protocol. Doctors have follow-up visit on 3 and 6 month after
      treatment, and do efficacy evaluation.
    

Intervention name(s): intrauterine injection; human umbilical cord mesenchymal stem cell
Intervention type(s): Procedure; Biological
Intervention description(s): intrauterine injection with umbilical cord mesenchymal stem cell (SCLnow 19#); one time/one menstrual cycle, total 2 times; 2 * 10^7 cells (2ml)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healing Poor After Uterus Injury, Mesenchymal Stem Cell
DuraSeal Sealant Post Market Study
Condition: Elective Cranial Procedures With Dural Incision
MeSH terms: Surgical Wound
Study type: Interventional

Summary: 
      DuraSeal Dural Sealant has been approved as a dural sealant by the FDA for use in cranial and
      spinal procedures. This study was completed to further evaluate the safety of the DuraSeal
      Sealant in a post-approval setting as compared to control (defined as methods typically
      employed by surgeons to seal the dura).
    


Intervention name(s): DuraSeal Dural Sealant System; Standard of Care
Intervention type(s): Device; Other
Intervention description(s): The DuraSeal™ Dural Sealant System is a polyethylene glycol (PEG) hydrogel that has been FDA approved as a dural sealant to achieve watertight dural closure in cranial and spinal surgery after primary repair with suturing is complete. It was developed as a means of providing a dural seal by covering small holes around the suture with an absorbable hydrogel. DuraSeal should only be used with autologous duraplasty material.; Standard procedure to obtain intraoperative watertight dural closure. These methods could have included additional sutures, adhesive glue, absorbable gelatin sponge, dural substitute, soft tissue patch, or another method typically used by the investigator.
Other intervention name(s): Standard procedure to obtain intraoperative watertight dural closure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Knowledge, Attitude and Practices of Flemish Midwifes Regarding Spontaneous Abortion
Condition: Spontaneous Abortion
MeSH terms: Abortion, Spontaneous
Study type: Interventional

Summary: 
      KAP-study in Flemish midwives with intramural employment
    

Detailed description: 
      The study will be conducted using a self designed questionnaire administered in midwives who
      are employed within a Flemish hospital in one of the following departments: maternity,
      maternal intensive care, (intensive) neonatology, reproductive medicine, gynaecology,
      delivery and prenatal care. The questionnaire assesses the knowledge, attitude and practices
      of the midwives regarding spontaneous abortion.
    

Intervention name(s): survey
Intervention type(s): Other
Intervention description(s): questionnaire assessing the knowlegde, attitude and practices regarding spontaneous abortion
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: miscarriage; Flanders; spontaneous abortion; KAP; midwives
A Study to Compare the Relative Bioavailability of Moexipril HCl/Hydrochlorothiazide in Healthy Adult Volunteers Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to evaluate the relative bioavailability of Paddock
      Laboratories, Inc.'s test formulation of Moexipril/ Hydrochlorothiazide 15mg/25mg tablets
      with a reference formulation Uniretic®(Moexipril/ Hydrochlorothiazide) 15mg/25mg tablets,
      under fasting conditions.
    


Intervention name(s): Moexipril HCl/ Hydrochlorothiazide 15mg/ 25mg Tablet, Paddock Laboratories, Inc.; Uniretic® 15mg/25mg Tablets
Intervention type(s): Drug; Drug
Intervention description(s): test drug; reference drug
Intervention MeSH terms: Hydrochlorothiazide; Moexipril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Subjects; Bioequivalence