bioihbjkbjnl/mcl2 huggingface dataset:
Improving Health in Low Income Women Following the Birth of a Child
Condition: Health Promotion
Study type: Interventional

Summary: 
      This study will evaluate a community-based program to improve diet and physical activity in
      women during the first 12 months following the birth of a child. The program is designed to
      complement existing federal programs for low-income families and is directed toward
      low-income, postpartum, multi-ethnic women.
    

Detailed description: 
      The postpartum period is a window of opportunity to promote behaviors that reduce the risk of
      chronic disease and benefit reproductive health. The Expanded Food and Nutrition Education
      Program (EFNEP) is an educational program delivered by community-based paraprofessional's
      that aims to improve dietary and activity patterns among low income, multi-ethnic women
      during the postpartum period. This study will evaluate the efficacy of the EFNEP to impact
      the diet and activity patterns of women.

      Women were recruited through the Special Supplemental Food Program for Women, Infants, and
      Children (WIC) and randomized to either the EFNEP group or a usual care group. Women in both
      groups will receive standard WIC care consisting of nutrition-risk and breastfeeding
      educational messages at postpartum and follow-up visits. Women in the EFNEP group
      participated in an additional two component intervention that included five home visits and
      motivational telephone calls from project staff.

      Primary study outcomes were assessed at Months 1 and 12. Primary outcomes included fruit and
      vegetable intake, saturated fat intake, and physical activity. Secondary outcomes will
      include Body Mass Index and indicators of fat mass and distribution. The study will also
      analyze mediating and modifying factors, including social support and norms, perceived health
      status, smoking, television viewing, food insecurity, food and activity access, and
      utilization of federal programs and health care.
    

Intervention name(s): Nutrition and physical activity program
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single
Primary purpose: Prevention
Keywords: Postpartum; Low income; Diet; Physical activity
OK432 (Picibanil) in the Treatment of Lymphatic Malformations
Condition: Lymphatic Malformations
MeSH terms: Lymphangioma; Lymphatic Abnormalities; Congenital Abnormalities
Study type: Interventional
Phase: Phase 2

Summary: 
      Standard of care for Lymphatic Malformations has been surgical excision. We have been using
      OK432/Picibanil (generously supplied by Chugai Pharmaceuticals in Japan) since 1992 with
      great success for macrocystic disease.

      The objective of the study was to provide OK-432 immunotherapy to subjects with macrocystic
      or mixed (> 50% macrocystic) lymphatic malformations (LMs) and investigate the efficacy and
      safety of OK 432 as a treatment option in subjects with LMs.
    

Detailed description: 
      Lymphatic malformations are uncommon tumors that represent localized malformations in the
      development of the lymphatic system. They typically present in children under 2 years of age
      and in almost 50% of the cases, are diagnosed at birth. There is neither a racial nor a
      sexual tendency. The malformations can occur anywhere on the body, but typically they are in
      the head/neck area.

      Morbidity can be significant. Besides the obvious cosmetic deformity caused by these tumors,
      there is risk of infection and airway compromise and even obstruction. However, effective
      therapeutic options are limited. Small lesions can be observed, although spontaneous
      resolution is unlikely. For larger lesions, surgery has been the traditional form of therapy.
      In the head and neck, in particular, lymphangiomas typically wrap themselves around major
      neurovascular structures, making total excision removal difficult, if not impossible, and
      thus the likelihood of recurrence is quite high. Because of these surgical limitations,
      alternate therapies have been considered; including cryotherapy, diathermy, and chemical
      sclerotherapy.

      The investigators experience with using the drug for macrocystic disease(large cysts) since
      1992 in the United States has been very promising compared to traditional surgery. Recurrence
      rate to date, has been very minimal as well. (<2%)

      After the conclusion of the Phase 2 randomized study, all new subjects who presented with an
      LM and were eligible for treatment were treated under an open-label protocol for continued
      access to OK-432. This multicenter, open label study enrolled subjects between September 2005
      and November 2017.
    

Intervention name(s): OK432
Intervention type(s): Drug
Intervention description(s): OK432 will be injected at dosage of 0.01 to 0.05 mg/mL 6-12 weeks apart up to 4 injections total.
Other intervention name(s): Picibanil
Intervention MeSH terms: Picibanil
Intervention model: Single Group Assignment
Intervention model description: All eligible participants receive the actual drug.
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Meningococcal Immune Response Among Children Who Previously Received MenACWY Conjugate Vaccine
Condition: Meningococcal Meningitis
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective was to evaluate the persistence of bactericidal antibodies in children
      40 and 60 months of age previously enrolled in the V59P14 (NCT00474526) study who received
      Novartis MenACWY Conjugate Vaccine. The study also enrolled age-matched subjects who have
      never received any meningococcal vaccine (naïve subjects) to serve as a control group. In
      addition, the response of a booster dose at 60 months was evaluated.
    


Intervention name(s): Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal; ACWY; Conjugate Vaccine; Meningitis; Children; Persistence; Booster dose
The Effect of Dry Needling Treatment Combined With Physical Therapy in Patients With Cervical Spondylosis
Condition: Dry Needling; Cervical Spondylosis; Physical Therapy
MeSH terms: Spondylosis
Study type: Interventional

Summary: 
      In this study, it was aimed to determine whether dry needling treatment applied to the
      trigger points in the trapezius muscle in patients with chronic neck pain due to cervical
      spondylosis makes an additional contribution to the treatment results of the physical therapy
      and rehabilitation program.
    

Detailed description: 
      Among the evaluated patients, the patients meeting the inclusion and exclusion criteria will
      be randomized into 2 groups using the random numbers table.

      While physical therapy and rehabilitation program will be applied to one group, dry needling
      treatment will be applied to the trigger points in the upper trapezius region with the same
      program to the other group. Patients will be evaluated before treatment (day 0) and at the
      end of treatment (day 21).

      The randomization and evaluation of the patients will be done by Gül Tuğba Bulut, while the
      injection of the patients will be done by Alper Mengi.

      Gender, age, education level, occupation, neck pain duration, body mass index of the patients
      included in the study will be recorded.

      The patients will be evaluated in terms of pain intensity, number of active trigger points in
      the upper trapezius muscle, functional status, quality of life, anxiety and depression at
      before (day 0) and after treatment (day 21).
    

Intervention name(s): Dry needling; Physical therapy and rehabilitation
Intervention type(s): Other; Other
Intervention description(s): In addition to the physical therapy and exercise program, the dry needling group will consist of patients who have had 3 sessions of dry needling applied to the trigger points in the trapezius muscle, 5 days apart.; The physical therapy and rehabilitation group will consist of patients who will be applied the same exercise program together with the same physical therapy applications (superficial heat (infrared lamp), transcutaneous electrical nerve stimulation (TENS) and therapeutic ultrasound (TUS)) 5 sessions per week for 3 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Renal Denervation in Treatment Resistant Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      In patients with treatment resistant hypertension renal nerve ablation emerged as an
      effective interventional approach of treating hypertensive disease with a progressively
      increasing fall in blood pressure. Decreased activity of the sympathetic nervous system is
      one of the major underlying pathogenetic mechanism of the fall in blood pressure but the
      precise mechanisms that causes the fall in blood pressure in the short-term and, in
      particular, long-term remains elusive. The objective of the study is to understand the
      pathogenetic mechanisms of renal denervation beyond the reduced activity of the sympathetic
      nervous system. In 100 hypertensive patients most advanced technology will be applied, before
      and repeatedly after renal denervation, throughout the follow-up period of 1 year. Systemic
      activity of the renin angiotensin aldosterone system, renal perfusion (by MRI spin labeling
      technique), local activity of the renin angiotensin system in the kidney (urinary
      angiotensinogen concentrations), sodium excretion and total sodium content (23 Na-MRI
      technique) and vascular remodelling of small (retinal arterioles 50 - 150 µm) and large
      arteries (carotid - femoral pulse wave velocity and augmentation index, both measured over 24
      hours) will be assessed. Identification of the pathogenetic mechanisms involved in the fall
      in blood pressure after renal denervation may help to identify those hypertensive patients
      that profit most from renal nerve ablation in terms of blood pressure reduction.

      The investigators propose the following hypotheses why a progressive decrease in blood
      pressure happens, in addition to the decreased activity of the central nervous system, after
      renal nerve ablation:

      Short term effects:

      A)Preservation of renal function and perfusion B)Reduction of local RAS activity in the
      kidney C)Exaggerated sodium excretion immediately after renal nerve ablation

      Long term effects:

      D)Decrease of total sodium content after 6 and 12 months E)Improvement of vascular wall
      properties after 6 and 12 months
    


Intervention name(s): Renal denervation using Symplicity Catheter system
Intervention type(s): Device
Intervention description(s): percutaneous selective renal sympathetic nerve ablation with the use of the Symplicity Catheter system
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        treatment resistant hypertensive adults
Characterization of Vascular Effects of Angiotensin II in Dorsal Human Hand Veins.
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      The hypothesis is tested that stimulation with angiotensin II after blockade of the
      AT1-receptor results in venodilation in human healthy subjects in vivo.
    


Intervention name(s): irbesartan (drug)
Intervention type(s): Drug
Intervention MeSH terms: Irbesartan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Educational/Counseling/Training
Keywords: AT1-receptor; AT2-receptor; human pharmacology
Diagnosis of Functional Defecation Disorders in Childhood
Condition: Constipation; Fecal Incontinence
MeSH terms: Fecal Incontinence; Constipation
Study type: Observational

Summary: 
      Purpose To compare different kinds of diagnostic investigations in order to identify the most
      sensitive and least invasive when diagnosing constipation.
    

Detailed description: 
      Defecation disorders in children are extremely common especially constipation and fecal
      incontinence. International studies show that constipation make up approximately 3% of
      Pediatric Outpatient Clinic11 (192) and 25% of Pediatric gastroenterology consultations.
      Between 1,5-3% of all 4-12 year olds experience fecal incontinence.

      Constipation and fecal incontinence can be extremely physical unpleasant and can have
      significant ramifications for a child's emotional and social functioning eg. low self esteem.

      Though most agree that constipation and faecal incontinence are a considerable problem
      worldwide there is disagreement when it comes to a definition and diagnostic tools. Several
      definitions have been used. This has led to great difficulties when trying to estimate
      prevalence, understand and compare in order to improve different treatments.

      Hypothesis:

        -  It is possible to diagnose constipation accurately by using a combination of anamnesis,
           stool diary, physical examination and transabdominal ultrasonography

        -  Transabdominal ultrasonography is a safe and sensitive diagnostic tool and can be used
           as an alternative or substitute to rectal examination.

      Purpose To compare different kinds of diagnostic (tools) investigations in order to identify
      the most sensitive and least invasive when diagnosing constipation.

      Material and methods 60 children referred to the paediatric outpatient clinic with fecal
      incontinence or suspicion of constipation. The investigations include anamnesis and physical
      examination with rectal examination and transabdominal ultrasonography. Home registration of
      a stool diary based on the Bristol Scale for 3 weeks thereafter a Colonic transit time is
      performed.

      Data is compared to data from 30 healthy children that have gone through the same
      investigations except the CTT that is based on x-rays.
    

Observational model: Defined Population
Time perspective: Prospective
Keywords: constipation; fecal incontinence; diagnosis; children
Stress and Insomnia
Condition: Insomnia; Stress
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      Insomnia is characterized by rumination and worry over stressful events affecting nighttime
      sleep. Emotional reactions while stressful events are ongoing have not often been
      investigated in insomnia. In the current study stress reactions will be measured during a
      real-life simulation experiment with stressful events and investigate not only how previous
      sleep patterns affect emotional reactivity to the event but also how the emotional events
      affect sleep patterns the following night.

      Thirty-six female subjects (age 25-45 years) without sleep complaints (n=18) or with insomnia
      (n=18) will enroll in a interventional study measuring the reaction to and effects of either
      neutral or stressful events during driving. Through questionaires and intake polysomnography,
      clinical levels of depression and anxiety will be excluded as well as sleep medication use
      and alternative sleep disorders than insomnia. Stress levels will be measured through skin
      conductance and heart rate variability during events and through nighttime polysomnography
      (PSG). Effects on sleep architecture and arousal levels will be measured through nighttime
      PSG.

      Investigators hypothesize that subjects with insomnia, compared to subjects without sleep
      complaints, show stronger emotional reactions to stressful events and stronger effects of
      stress on sleep quality the following night. Results will facilitate a model for emotional
      reactivity in chronic sleep disruption which may aid to prevent short term sleep disruption
      converting into chronic insomnia and aid in developing customized insomnia treatment.
    


Intervention name(s): Stress reactions measurement during stressful and neutral driving sessions
Intervention type(s): Other
Intervention description(s): Stress effects will be measured during 3 driving sessions (training without events on Day 17, with neutral events on Day 18, with stressful events on Day19), through nighttime PSG and questionnaires.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Insomnia; Stress; Real-life stressful events
Effects of L-Carnitine on Gastric Emptying in Children With Drug Resistant Epilepsy on Ketogenic Diet
Condition: Ketogenic Diet
MeSH terms: Epilepsy; Drug Resistant Epilepsy
Study type: Interventional

Summary: 
      This study was conducted on thirty children aged from12 months to 18 years newly diagnosed
      with drug resistant epilepsy and following up at Pediatric Nutrition and Neurology Outpatient
      Clinics assigned randomly into 2 groups, group1: patients who started ketogenic diet with
      L-carnitine and group2: patients who started ketogenic diet only.
    


Intervention name(s): L- Carnitine; ketogenic diet
Intervention type(s): Dietary Supplement; Other
Intervention description(s): L-carnitine was taken after feeds in the form of tablets or dissolved tablets in a dose of 50 mg/kg/day, with maximum dose of 2 g/day.; ketogenic diet (KD) initiated under supervision of expert physician who considered patient's age, type of feeding, needs and preferences of the child and his/her family to select the type and initial ratio of KD therapy, KD ratio ranged from 1:1 to 4:1 of lipids to carbohydrates plus proteins in grams.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Endoscopic Evaluation After Esophagectomy
Condition: Esophageal Neoplasms; Constriction; Anastomotic Leak; Ischemia
MeSH terms: Esophageal Neoplasms; Ischemia; Anastomotic Leak; Constriction, Pathologic
Study type: Observational

Summary: 
      Gastric conduit ischemia or anastomotic breakdown after esophagectomy with cervical
      esophagogastrostomy often cause severe complications, such as leakage, necrotic organs, and
      strictures. Thus, the purpose of this study is the safety and efficacy of endoscopic
      evaluation about reconstructive organs after esophagectomy. The investigators evaluate
      endoscopic predictions using classifications in acute phase after esophagogastrostomy.
    

Detailed description: 
      Gastric conduit ischemia or anastomotic breakdown after esophagectomy with cervical
      esophagogastrostomy often cause severe complications, such as leakage, necrotic organs, and
      strictures. However the evaluation and prevention before developing gastric conduit ischemia
      have been established. The investigators have built a hypothesis that the evaluation for
      gastric mucosal ischemia in early phase after esophagectomy predict the complication of
      gastric conduit. Thus, the purpose of this study is the safety and efficacy of endoscopic
      evaluation about reconstructive organs after esophagectomy. The investigators evaluate
      endoscopic predictions using classifications in acute phase after esophagogastrostomy.
    

Intervention name(s): Patients after esophagectomy
Intervention type(s): Procedure
Intervention description(s): postoperative endoscopic evaluation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergo an esophagectomy with reconstruction by a gastric pull-up for malignant or
        end-stage benign esophageal disease. The patients have a cervical esophagogastrostomy.
      
Biospecimen description: 
      dmp-DNA
    
Keywords: esophagogastrostomy; gastric conduit ischemia; endoscopy
Study of Cabazitaxel in Patients With Metastatic Breast Cancer Previously Treated With Taxanes
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether cabazitaxel is effective in the treatment
      of metastatic breast cancer.
    


Intervention name(s): Cabazitaxel
Intervention type(s): Drug
Other intervention name(s): Jevtana; XRP6258
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HER-2 negative; Metastatic breast adenocarcinoma
A Comparison of Combivent UDV (Ipratropium 500mcg and Salbutamol 2.5mg) and Salbutamol UDV Alone (2.5mg)
Condition: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the bronchodilator efficacy of ipratropium plus salbutamol (Combivent) with
      salbutamol alone given every 20 minutes for three doses in asthmatic children with severe
      acute exacerbation
    

Detailed description: 
      A Comparison of Ipratropium 500mcg and salbutamol 2.5mg (Combivent UDV) and salbutamol UDV
      alone (2.5mg) in a Double-blind, Efficacy and Safety Study in Asthmatic Children with Severe
      Acute Exacerbation

      Study Hypothesis:

      Several studies, including a study conducted in an emergency room setting, demonstrated that
      the addition of ipratropium bromide, an anticholinergic drug, to standard salbutamol therapy
      significantly improves pulmonary function as compared to salbutamol alone.

      Comparison(s):

      Ipratropium bromide 500 mcg plus salbutamol 2.5mg (Combivent) vs salbutamol (2.5mg) alone
      given every 20 minutes for 3 doses
    

Intervention name(s): ipratropium plus salbutamol UDV; salbutamol UDV
Intervention type(s): Drug; Drug
Intervention MeSH terms: Albuterol; Ipratropium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Management of Acute Heart Failure: Contribution of Ultrasound Daily "in Bed Patient" Adjustment on Therapy With Impact Measure on re Hospital Rate During 30 Days
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      Our hypothesis: a daily bedside echocardiographic assessment, protocolized, simple and
      reproducible estimation of filling pressures with an evaluation of mitral inflow and the
      inferior vena cava, allow a more reliable estimate of the true blood volume of the patient
      and thus lead to a therapeutic adjustment more suitable.

      This therapeutic adjustment closer to patient's needs would impact fewer readmissions at 30
      days and mortality, less alteration of biological parameters myocardial, kidney and liver.
    


Intervention name(s): Transmitral flow estimation
Intervention type(s): Procedure
Intervention description(s): Estimation of the transmitral flow of the inferior vena cava and its variations
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bedside echography