bioihbjkbjnl/mcl2 huggingface dataset:
Tai Chi for Enhancing Motor and Cognitive Function in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The purpose of this feasibility study is to preliminarily evaluate the effects of Tai Chi - a
      mind-body exercise - on motor and cognitive function as well as quality of life in
      individuals recently diagnosed with Parkinson's disease (PD).
    

Detailed description: 
      Specific Aim 1: To assess the feasibility of recruiting and retaining individuals with PD
      into a 6-month randomized controlled trial of Tai Chi exercise.

      Specific Aim 2: To collect preliminary data on the efficacy of Tai Chi on improving gait and
      balance dynamics, physical and cognitive function, exercise activity, self-efficacy, mood,
      and quality of life in individuals with PD.
    

Intervention name(s): Tai Chi
Intervention type(s): Other
Intervention description(s): 6-month Tai Chi exercise program meeting 2 times per week plus DVD for home practice
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Antenatal Betamethasone Compared to Dexamethasone - "BETACODE TRIAL"
Condition: Respiratory Distress Syndrome; Intraventricular Hemorrhage; Neonatal Mortality
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Hemorrhage
Study type: Interventional

Summary: 
      Antenatal corticosteroids result in substantial decrease in neonatal morbidity and mortality
      by specifically reducing the risk of respiratory distress syndrome, intraventricular
      hemorrhage and neonatal death among premature infants. No human randomized study has formally
      compared betamethasone and dexamethasone, the preferred corticosteroids for antenatal
      therapy, with regards to their effectiveness in reducing neonatal morbidities and mortality.
      Our objective was to compare betamethasone with dexamethasone in terms of effectiveness in
      reducing perinatal morbidities and mortality among preterm infants.
    

Detailed description: 
      We conducted a double blind placebo-controlled randomized trial of antenatal betamethasone
      compared to dexamethasone among women at risk of preterm deliveries at Stony Brook University
      Hospital from August 1, 2002 through July 31, 2004. We excluded women with clinical
      chorioamnionitis, major fetal structural anomalies, fetal chromosomal abnormalities, prior
      antenatal steroid exposure, and use of betamethasone or dexamethasone for other medical
      indications, quadruplets and higher order multiple gestation and those who declined
      enrollment. Consenting women were randomly allocated to one of two groups by the Pharmacy
      using computer generated random numbers. The statistical analysis was performed in accordance
      of the intention-to-treat principle. Student t test, Chi square and Fisher exact test were
      used for analysis. A P value of < .05 was considered statistically significant.
    

Intervention name(s): Betamethasone(Celestone soluspan) and Dexamethasone
Intervention type(s): Drug
Intervention MeSH terms: Dexamethasone; Betamethasone; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Betamethasone benzoate; Betamethasone acetate phosphate; Betamethasone sodium phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Antenatal corticosteroids; Betamethasone; Dexamethasone; Premature
Natural History of Infantile Neuroaxonal Dystrophy
Condition: Infantile Neuroaxonal Dystrophy; INAD
MeSH terms: Neuroaxonal Dystrophies
Study type: Observational

Summary: 
      This is a retrospective and cross-sectional review of the natural history of INAD.
    

Detailed description: 
      After obtaining informed consent, the study participants' relevant medical records will be
      collected and reviewed. If needed, a telephone or video conference will be scheduled with the
      patient's family to confirm and clarify information in the medical record. Deceased patients
      may be eligible for inclusion the retrospective registry if medical records are sufficient
      and indicate eligibility. Data will be pooled and presented in aggregate, without
      identification of individual subjects.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Living or deceased males or females with a diagnosis of classic INAD between the ages of 18
        months and 10 years of age.
      
Keywords: Infantile Neuroaxonal Dystrophy; INAD; PLA2G6
Folate Gene Polymorphisms and Cellular Folate Speciation Pilot Study
Condition: Single Nucleotide Polymorphism
Study type: Observational

Summary: 
      This pilot study is designed to investigate differences in folate-related genes (single
      nucleotide polymorphisms) and their relationship to the species of folate present on red
      blood cells.
    

Detailed description: 
      The main questions to be addressed in this pilot study are:

        1. what is the type of folate in red blood cells in individuals with different
           methylterahydrofolate reductase (MTHFR) genotypes

        2. what is the relationship between other folate metabolism-related gene single nucleotide
           polymorphisms and type (species) of folate found in red blood cells

        3. what is the relationship between folate and other B vitamin status, genotype and folate
           species

        4. is there a relationship between serum ferritin status and folate metabolism

      Whole blood will be taken from apparently healthy male and female volunteers, aged 18-65,
      which will be used to determine genotype for various folate metabolism-related genes.
      Furthermore, the type of folate present on the red blood cells will be assessed, and folate,
      vitamin B12, riboflavin and serum ferritin status determined.
    

Sampling method: Non-Probability Sample
Study population: 
        Healthy adults (male and female) aged 18-65
      
Biospecimen description: 
      One-off blood sample collected. DNA extracted for genotyping of folate metabolism-related
      gene single nucleotide polymorphisms
    
Keywords: Folate; Methylenetetrahydrofolate reductase; Speciation; Nutrient status; Bioavailability; Polymorphism, single nucleotide
Orlistat Reduces Uric Acid in Overweight/Obese Patients With Hyperuricemia
Condition: Uric Acid
MeSH terms: Overweight; Hyperuricemia
Study type: Interventional
Phase: Phase 4

Summary: 
      To clarify the uric acid-lowering efficacy of orlistat in overweight/obese patients with
      hyperuricemia, and to evaluate the safety of orlistat treatment
    


Intervention name(s): Orlistat; Orlistat placebo
Intervention type(s): Drug; Drug
Intervention description(s): Orlistat was administered orally on the basis of lifestyle guidance . Orlistat: Take 0.12g (1 capsule) with or within one hour after meals, 3 times a day. Medication time course: continuous administration for a total of 12 weeks.; Lifestyle guidance: low-purine diet; orlistat placebo: take 1 capsule with or within one hour after a meal, 3 times a day. Medication time course: continuous administration for a total of 12 weeks.
Intervention MeSH terms: Orlistat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Increased Microcirculation for Preventing Postoperative Wound Infections in Patients Undergoing Reduction Mammoplasty
Condition: Surgical Side Infections After Breast Reduction
MeSH terms: Infections; Communicable Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      In this prospective study we investigated the impact of an improved postoperative
      microcirculation and its effect of surgical side infections after breast reduction.
    

Detailed description: 
      Many studies identifying risk factors for surgical side infections (SSI) after breast surgery
      included a large percentage of breast conserving therapies and risk factors for patients
      undergoing more extensive procedures like breast reduction (BR) are underrepresented and risk
      factors for more extensive breast surgeries might not be identified. Our approach to decrease
      SSI after BR was the application of an i.v. isotonic crystalloid solution, 6%
      hydroxyethylstaerke (HES) as a diminished peripheral blood flow and impaired vasculogenesis
      are characteristics of poorly healing wounds. HES causes a medium- to long-term increase in
      blood volume, blood flow and improved blood oxygen transport. Blood flow and tissue
      oxygenation are parts of regulating the healing process by utilizing molecular oxygen as a
      terminal oxidant. This antioxidant capacity can influence the wound healing process
      positively, as a characteristic feature of the inflammatory phase is the oxidative burst. HES
      additionally decreases haematocrite, blood viscosity and aggregation of erythrocytes
      positively influencing the complex components regulating wound healing. These characteristics
      and the increase in blood circulation might influence the postoperative healing and
      regeneration process.
    

Intervention name(s): 250ml HES 6%; 9% NaCl 500ml
Intervention type(s): Drug; Drug
Intervention description(s): Application twice a day 250ml HES 6% for three days postoperatively.; Application twice a day 500ml 9% NaCl for three days postoperatively.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: surgical side infection; breast reduction; reduction mammaplasty; prospective trial; microcirculation; breast surgery
Switch Study of Existing Atypical Antipsychotics to Bifeprunox
Condition: Schizophrenia and Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will evaluate the safety and tolerability of switching subjects with schizophrenia
      or schizoaffective disorder from their existing antipsychotic medication to Bifeprunox.
    


Intervention name(s): Aripiprazole; Olanzapine; Risperidone; Quetiapine; Ziprasidone; Aripiprazole; Olanzapine; Risperidone; Quetiapine; Ziprasidone
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox; Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox; Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox; Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox; Abrupt discontinuation of prior anti-psychotic med after a successful eight-day up titration of bifeprunox; Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days; Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days; Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days; Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days; Cross-tapering during which prior anti-psychotic med will be tapered off at the same time while bifeprunox is being titrated up within 8 days
Intervention MeSH terms: Olanzapine; Risperidone; Aripiprazole; Quetiapine Fumarate; Ziprasidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Switch Study; Schizophrenia; Atypical Antipsychotics
Food4GutMarKIT - Evaluation of a Tailored Personalized Food Concept for a Healthy Gut Microbiota and Validation of Biomarkers for Monitoring of Its Effects
Condition: Healthy, Overweight, Obese
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The overall aim in this "proof-of-concept" study is to evaluate if a diet concept, based on
      foods that have individually been reported to beneficially affect gut microbiota in fact has
      an effect on gut microbiota composition and activity among healthy and obese subjects and
      whether the effects are associated with altered cardiometabolic risk factors. The aim is
      further to investigate if such alterations are reflected in changes of the fecal and plasma
      metabolome. In total, 40 men and women, who meet all the inclusion criteria and none of the
      exclusion criteria will be invited to participate in the study. The participants will follow
      an intervention diet for 6 weeks and a control diet for 6 weeks, with a 6-week wash-out
      period in between and will be randomized to either begin with the intervention diet or the
      control diet.

      The study will be running over 18 weeks (including a 6-week wash-out period) and it will
      include 9 visits at the clinic.
    


Intervention name(s): Diet
Intervention type(s): Other
Intervention description(s): A review has been undertaken to both identify specific bacteria associated with cardiometabolic risk factors and food items that have been shown to affect such bacteria in a beneficial direction. The intervention diet will include a variety of food items e.g. vegetables, fermented vegetables, fermented dairy products and cereal products. The control diet is based on a Swedish Average Diet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Corneal Endothelial Cell Loss After Phacoemulsification Compared With Extracapsular Cataract Extraction
Condition: Senile Cataract
MeSH terms: Cataract; Corneal Endothelial Cell Loss
Study type: Observational

Summary: 
      the investigators will compare between the endothelial cell loss after phacoemulsification
      and extracapsular cataract extraction in management of senile cataract
    

Detailed description: 
      Age related cataract is believed to be the main cause of reversible blindness worldwide and
      in developing countries. Population-based studies have reported that cataract is responsible
      for 47.8% to 51% of all global blindness.

      Several studies compared phacoemulsification and conventional extracapsular cataract
      extraction regarding several aspects such as postoperative inflammation and visual
      rehabilitation. studies proved that phacoemulsification has faster rehabilitation ,less
      astigmatism and better postoperative vision .However, Extracapsular cataract extraction is
      still the operation of choice in some cataract cases.

      The normal corneal endothelium is a single layer of uniformly sized cells with a
      predominantly hexagonal shape. Adult density of approximately 2400 - 3200 cells/mm².The
      number of cells decreases at about 0.6% per year and neighbouring cells enlarge to fill the
      space as the cells cannot regenerate.The minimum cell density necessary for adequate function
      is in the range of 400 to 700 cells/mm2.

      The effect of cataract surgery on corneal endothelium is an important factor that affects
      postoperative vision .However, it is accepted all over the world that there is definite loss
      of some endothelial cells with all techniques of cataract surgery. Previously, cataract
      surgery caused enormous loss of endothelial cells , but with enhancement of equipment and
      surgical techniques, cataract surgery today results in 6-14%loss of endothelial cells.

      Specular microscopy is a noninvasive photographic technique that allows visualization and
      analysis of corneal endothelium. specular microscopy is used to show cell count and cell
      shape in the scanned area.
    

Intervention name(s): phacoemulsification; extracapsular cataract extraction
Intervention type(s): Procedure; Procedure
Intervention description(s): removal of cataract using ultrasound waves; removal of cataract using surgical corneal incision
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with senile cataract
Technology-Based Breastfeeding Training After Cesarean
Condition: Cesarean Section; Dehiscence; Breast Feeding; Self Efficacy
Study type: Observational [Patient Registry]

Summary: 
      Aim: The aim of this study was to determine the effect of breastfeeding training given with
      virtual reality (VR) to postpartum primiparous mothers on breastfeeding success and
      breastfeeding self-efficacy.

      Method: The research was designed as a prospective randomized controlled study. In total, 66
      women were included in the study, with 31 in the control group and 35 in the intervention
      group. The intervention group watched a breastfeeding video with VR in the 4th and 24th hours
      after cesarean. Research data were collected with the sociodemographic information form,
      LATCH Breastfeeding Charting System and Documentation Tool and the Breastfeeding
      Self-Efficacy Scale. The study included mothers who gave birth with cesarean section,
      received breastfeeding counseling during pregnancy, with no vision or hearing disabilities
      and without any neurological disorder.
    


Observational model: Other
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        mothers who gave birth with cesarean section
      
Keywords: breastfeeding success; cesarean; education technology; breastfeeding self-efficacy; virtual reality
Impedance Spectroscopy in Detection of Obstetric Anal Sphincter Injuries
Condition: Obstetric Anal Sphincter Injury; Delivery, Obstetric
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The main purpose of the study is to evaluate the effectiveness and safety of the impedance
      spectroscopy device prototype in detection of anal sphincter injuries in women in the early
      postpartum period. The study is prospective. The study group comprises 24 patients; included
      in it 6-8 weeks after natural delivery. The planned participation of each patient in the
      study is up to 4 weeks and three visits will take place at that time.

      After obtaining written consent, at the screening visit (V0) each patient will undergo a
      physical examination, blood samples for laboratory tests and stool samples for calprotectin
      concentration assessment will be collected.

      On the second visit (V1), after the final verification of inclusion/exclusion criteria,
      impedance spectroscopy using tested device will be performed in each patient, the electrical
      impedance of pelvic floor muscles will be measured and the degree of anal sphincter damage
      will be evaluated. Full gynecological and proctological examination (including a
      gynecological speculum, two-handed examination, rectal examination and anoscopy) will be
      carried out.

      On the third visit (V2), two reference diagnostic tests (with evidenced effectiveness and
      safety), transanal ultrasonography and anorectal manometry, will be conducted. The collected
      data will be used to select the optimal therapeutic method for each participant individually.
    


Intervention name(s): Blood and faeces tests; Impedance spectroscopy test; Full gynecological and proctological examination; Transanal ultrasonography; Anorectal manometry
Intervention type(s): Diagnostic Test; Device; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): During V0 - Laboratory tests, particularly for calprotectin concentration assessment; During V1 - the electrical impedance of pelvic floor muscles will be measured; During V1 - Examination with a gynecological speculum, Two-handed examination, Rectal examination and Anoscopy; During V2 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.; During V2 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Obstetrical anal sphincter injury; Impedance spectroscopy
Atomoxetine/Attention Deficit/ Hyperactive Disorder (ADHD)/Substance Use Disorder (SUD)in a Residential Treatment Facility
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Substance-Related Disorders; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      Although Attention Deficit/ Hyperactive Disorder (ADHD) is a common comorbidity in
      individuals diagnosed with Substance Use Disorder (SUD), little data currently exists on the
      utility of screening tools in large samples of adult patients with SUD in inpatient
      treatment. This was a 10-week, 2-phase, open label trial of atomoxetine for ADHD in adult
      patients being treated for a co-morbid SUD in a residential treatment facility (RTF). The
      primary objective of the study was to assess the efficacy of atomoxetine in adults with an
      SUD and ADHD. Secondary objects included assessment of the co-morbidity of ADHD and the
      safety and tolerability of atomoxetine in this population.
    

Detailed description: 
      Phase 1: Patients with SUD who were either newly admitted (abstinent for <1 week) or in
      treatment in the RTF (abstinent <3 months) were administered the Adult ADHD Self-Report Scale
      Symptom Checklist (ASRS) v. 1.1 Screener. Patients who screened positive(>= 4 out 6
      significant items) were then administered the Adult Clinician Diagnostic Scale (ACDS) v.1.2
      to establish a diagnosis of ADHD and the Predictive Value Positive (PVP) in this population.

      Phase II (Treatment): Participants who screened positive for ADHD on the ACDS were given
      informed consent and baseline evaluations for inclusion. Those meeting inclusion/exclusion
      criteria were treated with atomoxetine starting at 25 mg/day. The dose was adjusted based on
      clinical response and tolerability over a 4-week period up to 120 mg/day and held constant
      for the final six weeks of the trial.
    

Intervention name(s): Atomoxetine
Intervention type(s): Drug
Intervention description(s): In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant at the optimized level for the final 6 weeks of the trial.
Intervention MeSH terms: Atomoxetine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ADHD; Substance Use Disorder; Residential Treatment Facility