bioihbjkbjnl/mcl2 huggingface dataset:
Testing myWHI: Online Self-guided Programs for Migraine
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

Summary: 
      The goal for this pilot study is to assess the acceptability of two online self-guided
      programs for migraines. The programs are part of the investigators' collection of "my
      Wireless Headache Interventions" (myWHI). The Specialized Program for Headache Reduction
      (SPHERE) is a program that teaches cognitive and behavioural skills/techniques to help manage
      headaches. The PeRsonalized Intervention for Self-Management of Migraine (PRISM) helps users
      to discover their headache triggers and provides recommendations for managing them. This
      pilot will also assess the feasibility of the study protocol to inform a full scale
      randomized controlled trial (RCT).
    


Intervention name(s): SPHERE; PRISM
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
CHROENDOHNPCC: Early Detection of Pre-cancer Lesions in Adults With Hereditary Nonpolyposis Colorectal Cancer Syndrome
Condition: Colorectal Neoplasms, Hereditary Nonpolyposis
MeSH terms: Colorectal Neoplasms; Colorectal Neoplasms, Hereditary Nonpolyposis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to test the hypothesis that a chromoscopy colonoscopy is able to
      increase by 50 % the number of pre-cancer lesions or early cancer detected in patients with
      HNPCC syndrome, compared to a routine colonoscopy without chromoscopy.
    

Detailed description: 
      Patient with HNPCC syndrome confirmed by a mutation (MLH1, MSH2, MHS1) are involved in the
      study. Patient have 2 colonoscopy back to back. The second coloscopy is associated to
      chromoscopy with carmin indigo. Endoscopist are randomised for the colonoscopy with
      chromoscopy and are un-awarded of the result of the first colonoscopy. Histopathology of the
      polyp are noted. The follow up were 1 month.
    

Intervention name(s): Colonoscopy with chromoscopy
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Colorectal cancer; HNPCC; Diagnosis; Coloscopy; Chromoscopy; Indigo carmine; Colorectal Neoplasms; Hereditary Nonpolyposis
Local Anesthetic Infiltration and Infusion for Pain Control After Hip Replacement
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to examine three different ways to control pain after hip
      replacement:

        1. One time injection of ropivacaine before wound closure

        2. One time injection of ropivacaine before wound closure plus slow release of ropivacaine
           via catheter for 48 hours

        3. Standard practice of patient controlled pump
    


Intervention name(s): Ropivacaine infiltration and saline infusion.; Ropivacaine infiltration and infusion.; Normal Saline
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): 50ml ropivacaine 0.2% with keterolac 15mg infiltration followed by normal saline infusion at 5ml per hour; 50 ml infiltration of ropivacaine 0.2% and ketorolac 15mg admixture followed by ropivacaine 0.2 % at 5ml per hour infusion for 48 hours.; 50ml of normal saline infiltration followed by normal saline infusion at 5ml per hour
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Understanding the Genetic Basis of Familial Combined Hyperlipidemia in Mexican Individuals
Condition: Hyperlipidemia, Familial Combined; Coronary Disease
MeSH terms: Coronary Disease; Hyperlipidemia, Familial Combined; Hyperlipidemias; Hyperlipoproteinemias
Study type: Observational

Summary: 
      Familial combined hyperlipidemia (FCHL) is an inherited disorder characterized by elevated
      levels of cholesterol and triglycerides; it often occurs in Mexican individuals with coronary
      heart disease (CHD). The purpose of this study is to identify the specific genes that
      predispose Mexican individuals to FCHL.
    

Detailed description: 
      CHD is the leading cause of death in Mexico. Dyslipidemia that is characterized by high total
      cholesterol, high triglycerides, and low "good" high-density lipoprotein (HDL) cholesterol is
      a risk factor for developing CHD. Research has shown that the Mexican population has an
      increased tendency towards dyslipidemia, but it is not known what genetic factors contribute
      to this predisposition. This study will examine the genetic basis of FCHL, which is an
      inherited form of dyslipidemia characterized by elevated levels of total cholesterol and
      triglycerides. FCHL is a major contributing factor in CHD; 20% of individuals with CHD under
      the age of 60 have FCHL. The purpose of this study is to identify and characterize the
      specific DNA sequence variations that predispose Mexican individuals to FCHL. Results of this
      study may aid in the development of appropriate prevention and screening techniques.

      This study will enroll individuals in Mexico who have FCHL. Participants will attend one
      study visit for blood collection and DNA sampling. Family members of participants will be
      contacted and asked to provide a DNA sample also. A select group of participants will return
      for a second study visit for RNA sampling. Study researchers will analyze participants' DNA
      and RNA samples, as well as two FCHL genes identified in previous research studies.
    

Observational model: Family-Based
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Study subjects are Mexicans visiting the Dyslipidemia Clinic at the Instituto Nacional de
        Ciencias Medicas y Nutricion, Salvador Zubiran, Mexico City, and their family members
      
Biospecimen description: 
      Whole blood sample is taken from all participants and adipose tissue sample from a subgroup.
Butylphthalide for Preventing Restenosis After Intracranial and Extracranial Artery Stenting
Condition: Restenosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether butylphthalide are effective for Preventing
      Restenosis after Intracranial and Extracranial Artery Stenting
    

Detailed description: 
      Ischemic stroke is a significant cause of death, most of the patients is caused by
      atherosclerosis,current treatments include internal medicine medications, interventional
      treatment and so on,among them, the interventional therapy can make narrow blood vessels
      blood recovery fastly,and for its small trauma,Gradually accepted by psychiatrist, But stents
      are easy to narrow has been plagued by everybody ,At present, prevent restenosis stent is
      mainly of antiplatelet therapy,But,prevention effect is not obvious often easy to appear
      harmful response,how to effectively reduce postoperative restenosis, become the majority
      concern of patients and doctors .Clinical trials showed that, butylbenzene can promote the
      function of ischemic stroke recovery patients. Animal pharmacodynamics study suggests that
      this product can block the ischemic stroke of brain damage caused by DuoGe pathological link,
      with strong against ischemic and brain protection, especially can obviously increase in small
      brains ischemia ATP and phosphoric acid creatine level, decrease local cerebral ischemia in
      rats, reduce infarct size, cerebral edema improved energy metabolism and brain ischemia of
      microcirculation and blood flow in the brain, restrain the nerve cell apoptosis, and has the
      cerebral thrombosis and anti-platelet aggregation function. Research shows that, butylbenzene
      phthalocyanine influence through arachidonic acid (AA) metabolism, selective inhibition and
      their metabolites from DuoZhong mediated pathophysiological events, can remove microvascular
      spasms. Inhibit platelet aggregation, restrain TXA2 synthesis, scavenging free radicals,
      thereby through many ways, many link blocking caused by cerebral ischemia the pathophysiology
      of development process. These mechanisms may make butylbenzene in preventing phthalocyanine
      intracranial carotid stenting noted restenosis and related ischemia of events play an
      important role.
    

Intervention name(s): Butylphthalide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg/time per os three times a day. 180days; 20 mg/time per os three times a day. 180days
Other intervention name(s): NBP
Intervention MeSH terms: 3-n-butylphthalide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Butylphthalide
The Role of Oxytocin in Modulating the Effects of Social Feedback on Achieving Personal Goals
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To examine potential differential effects of receiving various social feedback on achieving
      personal goals,and whether oxytocin would modulate these effects.
    

Detailed description: 
      In the present study, 62 healthy male participants participated in the double-blind,
      placebo-controlled experiment. Investigators aimed to test the idea that whether oxytocin
      would modulate subjective responses during receiving various social reward and social
      punishment about the future outcomes of pursuing personal goals.
    

Intervention name(s): oxytocin treatment; placebo treatment
Intervention type(s): Drug; Drug
Intervention description(s): intranasal administration of oxytocin (40 IU); intranasal administration of placebo (40 IU)
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: oxytocin; social reward; social punishment
Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to compare the efficacy and safety of budesonide MMX 9 mg versus placebo as
      add-on therapy to an existing oral 5-ASA regimen for the induction of remission in
      participants with active mild or moderate ulcerative colitis (UC).
    

Detailed description: 
      Eligible participants will be randomized to 1 of the following 2 treatment arms:

        1. Budesonide MMX 9 mg (1 tablet)

        2. Placebo (tablet indistinguishable from budesonide MMX 9 mg tablet)

      The assigned study drug will be taken as a single oral tablet each morning after breakfast.
      In addition to the study drug, all participants will continue their existing background oral
      5-ASA regimen during the treatment period.
    

Intervention name(s): Budesonide MMX®; Placebo; 5-ASA
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral tablet taken daily in the morning after breakfast.; Matching budesonide MMX placebo oral tablet taken daily in the morning after breakfast.; Acceptable oral 5-ASA medications to be received during the study include:
Asacol®, Asacol® HD, Lialda®, Pentasa® (generic: mesalamine), minimum daily dose ≥2.4 grams (g)
Azulfidine® (generic: sulfasalazine), minimum daily dose ≥4.0 g
Dipentum® (generic: olsalazine), minimum daily dose ≥2.0 g
Colazal®, Colazide® (generic: balsalazide), minimum daily dose ≥6.75 g
Other intervention name(s): Budesonide Multi-Matrix System
Intervention MeSH terms: Budesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ulcerative Colitis
Follow-up in Rivaroxaban Patients in Setting of Thromboembolism
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Study type: Observational [Patient Registry]

Summary: 
      In patients with acute clots (deep vein thrombosis or pulmonary embolism) the investigators
      will collect real world data on their short and long term outcomes. The investigators
      hypothesise that in patients treated from the outset with rivaroxaban that: 1. treatment will
      be non-inferior to treatment with conventional anticoagulants (heparins and warfarin); 2.
      there will be less bleeding than when patients are on conventional anticoagulants; 3. there
      will be a lower long-term incidence of morbidity from chronic thromboembolic pulmonary
      hypertension and post-thrombotic limb syndrome.
    

Detailed description: 
      United Kingdom-only prospective, non-interventional, investigator-led, multi-centre, single
      cohort, registry. The observation period for each patient covers the treatment period with
      rivaroxaban and follow up until study end. For each patient, the treating health care
      professional records patient demographics, medical history, signs and symptoms, diagnosis,
      treatment and safety parameters at an initial visit and subsequent follow-up visit(s). Data
      monitoring will be undertaken by the Sponsor.
    

Intervention name(s): Non-interventional study
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients aged 18-99 years with acute DVT or PE treated with rivaroxaban, patients will have
        not recieved bridging anticoagulation
      
Keywords: Pulmonary embolism; PE; Deep vein thrombosis; DVT; Rivaroxaban; Venous thromboembolism; Chronic thromboembolic pulmonary hypertension; Post thrombotic limb syndrome; Root cause analysis
To Demonstrate the Relative Bioavailability of Azithromycin 600 mg Tablets Under Fed Conditions
Condition: Infection
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      To demonstrate the bioequivalence of Azithromycin 600 mg Tablets Under Fed Conditions.
    


Intervention name(s): Azithromycin Monohydrate 600 mg Tablets; Zithromax (azithromycin dihydrate) 600 mg Tablets
Intervention type(s): Drug; Drug
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Microtransplantation With Decitabine and Cytarabine Improves Patient Outcomes in Myelodysplastic Syndromes
Condition: Myelodysplastic Syndromes
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to investigate whether infusion of G-CSF mobilized
      HLA-mismatched peripheral blood stem cells (G-PBSC) combining decitabine and cytarabine
      chemotherapy can improve outcomes in myelodysplastic syndromes (MDS) patients.
    


Intervention name(s): Microtransplantation
Intervention type(s): Biological
Intervention description(s): Infusion of G-CSF mobilized HLA-mismatched peripheral blood stem cells (G-PBSC)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Decitabine; microtransplantation; myelodysplastic syndromes; chemotherapy
A Blind Maneuver to Position an Endobronchial Blocker
Condition: One Lung Ventilation; Endobronchial Blocker; Thoracic Surgery; Fiberoptic Bronchoscopy
Study type: Observational

Summary: 
      One-lung ventilation can be provided by an endobronchial blocker. The Uniblocker® (Fuji
      Systems Corporation, Tokyo, Japan) was relatively recently introduced into clinical practice.
      We will try to devise a blind method to locate the Uniblocker® without the aid of fiberoptic
      bronchoscopy.
    

Detailed description: 
      The use of a fiberoptic bronchoscopy (FOB) appears to be fundamental to adjusting position of
      the bronchial blocker in the targeted mainstem bronchus. However, there can be occasions when
      a FOB is unavailable or inapplicable. Therefore, we will try to devise a blind method to
      locate the blocker without the aid of FOB in patients undergoing thoracic surgery.

      After intubation of endotracheal tube (ETT), the Uniblocker® is inserted into the ETT and is
      advanced until the blocker balloon comes out of the ETT tip. At this time, the blocker
      balloon is inflated with air and the peak inspiratory pressure (PIP) will abruptly increase.
      And then, the blocker is rotated to the thoracotomy side and advanced to the carina step by
      step at 0.5 cm intervals. When the PIP drops abruptly, the blocker cuff is deflated
      completely and advanced to 3 cm further. The blocker cuff is inflated again. Using a FOB, the
      position of the blocker is recorded and we will evaluate the success rate of proper blocker
      position.
    

Intervention name(s): endobronchial blocker
Intervention type(s): Procedure
Intervention description(s): After intubation of endotracheal tube, the Uniblocker® was inserted into the endotracheal tube and advanced step by step with inflation of the blocker balloon until the peak inspiratory pressure dropped abruptly.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients undergoing thoracic surgery
DNA Methylation and Lung Disease in Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Lung Diseases; Fibrosis
Study type: Interventional

Summary: 
      Lung disease progression is variable among cystic fibrosis (CF) patients and depends on DNA
      mutations in the CFTR gene, polymorphic variations in disease-modifier genes and
      environmental exposure. The contribution of genetic factors has been extensively
      investigated, whereas the mechanism whereby environmental factors modulate the lung disease
      is unknown. Because these factors can affect the epigenome, investigators hypothesized that
      DNA methylation variations at disease-modifier genes modulate the lung function in CF
      patients.
    

Detailed description: 
      Lung disease progression is variable among cystic fibrosis (CF) patients and depends on DNA
      mutations in the CFTR gene, polymorphic variations in disease-modifier genes and
      environmental exposure. The contribution of genetic factors has been extensively
      investigated, whereas the mechanism whereby environmental factors modulate the lung disease
      is unknown. Because these factors can affect the epigenome, investigators hypothesized that
      DNA methylation variations at disease-modifier genes modulate the lung function in CF
      patients.

      The investigators analyzed DNA methylation levels in the promoter of fourteen lung
      disease-modifier genes and showed that DNA methylation levels are altered in nasal epithelial
      and blood cell samples from CF patients. This study disclosed slightly, but significantly
      differentially methylated regions that collectively may modulate lung disease severity. It
      also highlighted that complex relationships between genetic and epigenetic factors contribute
      to the phenotypic variability of CF patients.
    

Intervention name(s): nasal epithelial; Blood sampling
Intervention type(s): Other; Other
Intervention description(s): CF patients with the same procedures as in the usual management of routine care, only the sampling nasal epithelial cells will be added; CF patients with the same procedures as in the usual management of routine care, only the sampling 5ml additional blood will be taken
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Lung disease; Epigenetics; DNA methylation; Modifier genes
Evaluation of a Primary Care Weight Management Program in Children Aged 2 to 5 Years
Condition: Childhood Obesity; Feeding Behavior; Physical Activity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      Primary care offers a promising setting for promoting parenting practices that shape healthy
      eating and physical activity behaviors of young children. This study assessed the impact of a
      parent-based, primary care intervention on the feeding habits, health behaviors, and body
      mass index (BMI) of 2-5 year olds with elevated or rapidly-increasing BMI. Four private
      pediatric offices in West Michigan were assigned as control (n=2) or intervention (n=2) sites
      based on patient load and demographics. Treatment families were recruited at well-child
      visits to receive physician health-behavior counseling and four visits with a registered
      dietitian nutritionist (RDN) over a 6-month period. Outcomes included percent of the 95th BMI
      percentile (%BMI95), the Family Nutrition and Physical Activity survey (FNPA), and the
      Feeding Practices and Structure Questionnaire (FPSQ).
    


Intervention name(s): Behavior-based parental intervention
Intervention type(s): Behavioral
Intervention description(s): Behavioral intervention designed to promote healthy feeding behaviors in parents of 2-5 year olds, and to modify parenting practices in a way that encourages adequate physical activity, sufficient sleep, and healthy nutrition, while limiting sedentary behaviors.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: We Are for Children, LLC (WAFC), is a collaboration of non-profit pediatric practices in West Michigan formed to help members respond to healthcare needs. Four primary care pediatric offices from WAFC were selected to participate in the current study based on site interest and capacity. Participating pediatric offices were then matched into pairs based on similarities in office size (i.e. physician FTEs and patient load) and patient demographics characteristics, after which one of each matched pair was assigned as a treatment or control site.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric obesity; preschool children; non-responsive feeding; body mass index; parenting