bioihbjkbjnl/mcl2 huggingface dataset:
Burch Colposuspension and Mid-urethral Sling Operations
Condition: Incontinence
Study type: Observational [Patient Registry]

Summary: 
      Stress urinary incontinence is common in women. the treatment of this condition is surgery.
      investigators add stress incontinence surgery to patients who undergo total laparoscopic
      hysterectomy for benign reasons.

      Depending on the patient's general condition and indications, the operation can be performed
      by vaginal approach, as well as mid-urethral sling operations and laparoscopic burch
      colposuspension.

      The researchers aimed to compare these two types of operations performed on patients. In this
      way, the superiority and disadvantage of each other in two procedures will be demonstrated.
    


Intervention name(s): total laparoscopic hysterectomy and simultaneous incontinence surgery with benign causes
Intervention type(s): Procedure
Intervention description(s): total laparoscopic hysterectomy and simultaneous incontinence surgery with benign causes; Burch colposuspension and mid-urethral sling operations for stress urinary incontinence
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total laparoscopic hysterectomy was planned for benign causes, Patients who underwent
        simultaneous operation for incontinence
Nalmefene Gambling Study: Study of Nalmefene HCl in the Treatment of Pathological Gambling
Condition: Pathological Gambling
MeSH terms: Gambling
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine if nalmefene is safe and effective in the treatment
      of pathological gambling.
    

Detailed description: 
      Randomized, double-blind, placebo-controlled, parallel-group, multi-centered, outpatient
      study to assess the efficacy, safety and tolerability of two doses of nalmefene in patients
      with current diagnosis of pathological gambling.
    

Intervention name(s): nalmefene HCl; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Nalmefene HCl film-coated tablets, 20 or 40 mg, administered orally once daily for 10 weeks.; Placebo tablet
Intervention MeSH terms: Nalmefene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Retrospective CT Imaging of BioComposite Interference Screw With BTB
Condition: ACL Tear
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Observational

Summary: 
      The purpose of this study is to examine the long-term appearance and resorption rate of
      biocomposite screws used during ACL reconstruction on X-ray and computed tomography (CT).
    


Intervention name(s): Bioabsorbable screw fixation
Intervention type(s): Procedure
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults aged 18+ who had an anterior cruciate ligament (ACL) reconstruction about 5 years
        ago performed by one of the study investigators.
Holmium Laser Uretherotomy in Combination With Intralesional Steroids in Bulbar Uretheral Stricture
Condition: Urethral Stricture
MeSH terms: Urethral Stricture; Constriction, Pathologic
Study type: Interventional

Summary: 
      the purpose is to evaluate the outcome of visual internal uretherotomy with Holmium laser
      along with intralesional steroid injection.
    

Detailed description: 
      In this study, the investigator evaluates the efficacy of Holmium laser in combination with
      intra lesional steroid injection in the treatment of bulbar urethral strictures
    

Intervention name(s): Laser uretherotomy; Laser uretherotomy with triamcinolone
Intervention type(s): Procedure; Procedure
Intervention description(s): Holmium YAG Laser with pulse energy from 1-2 Joule, frequency from 10-15 Hertz and total power from 3.0 to 30.0 Watt were set up, respectively, based on the extent of the lesions. Scar tissue was incised at the position of 12-o'clock under the guidance of guidewire or ureteric catheter till fresh mucosa appeared.; After laser urethrotomy, 80 mg of triamcinolone (diluted with normal saline to 10 ml) will be injected by using an injection needle (5 F size and 23 G needle size) at 10 sites, 1 ml each, along the site of urethrotomy and circumferentially.
Intervention MeSH terms: Triamcinolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Sevelamer Hydrochloride and Femoral and Carotid Intima Media Thickness Progression in End Stage Renal Disease
Condition: End Stage Renal Disease; Hemodialysis; Intimal Media Thickness
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional

Summary: 
      Aims of the multi-center, randomized, treatment-controlled clinical trial are to compare the
      efficacy of sevelamer hydrochloride to calcium-containing phosphorus binders in reducing the
      rate of progression of femoral and carotid intimal media thickness (IMT) thickening as
      measured by B-mode ultrasound in stable maintenance hemodialysis (HD) patients.
    

Detailed description: 
      Serum phosphorus (P) is frequently elevated in HD patients. Serum P stimulates PTH synthesis
      and is associated with secondary hyperparathyroidism. Use of calcium(Ca)-containing
      phosphorus-binders is an exogenous source of Ca that can elevate the CaxP product. In HD
      patients, an ultrasonographically-demonstrated increase in intima media thickness of the
      carotid artery has been associated with elevated serum P levels.Peripheral arterial vascular
      disease (PVD) accounts for significant mortality and morbidity in HD patients.

      The aim of this study is to compare the efficacy of sevelamer hydrochloride to
      calcium-containing phosphorus binders in reducing the rate of progression of femoral and
      carotid intimal media thickness (IMT) thickening as measured by B-mode ultrasound in stable
      HD patients.

      Subject randomization numbers was provided by the Epidemiology and Research Unit, E. Wolfson
      Medical Center, Holon, Israel. After meeting all inclusion criteria, subjects were randomized
      to one of two treatment groups: Renagel or calcium carbonate. Prior to receiving treatment,
      baseline femoral and carotid IMT were measured, medical and pharmaceutical history was
      documented, nutrition assessment was undertaken and midweek blood chemistry and blood count
      were measured. No change in patient medication prescription was required during this study,
      with the exception of phosphorus binders. All other concomitant medications were continued.
      During the year of the study, routine monthly blood tests were obtained for chemistry, blood
      count, and PTH was measured once every 4 months.

      After a year of treatment, femoral and carotid IMT were measured again, midweek blood
      chemistry and blood count were measured.
    

Intervention name(s): sevelamer hydrochloride; Calcium Carbonate
Intervention type(s): Drug; Drug
Intervention description(s): 800-3200 mg with each meal; 600 mg with each meal, up to 1800 mg a day
Other intervention name(s): Renagel; Caltrate, Calcimor
Intervention MeSH terms: Calcium Carbonate; Calcium; Sevelamer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hemodialysis; intimal media thickness
The Safety, Tolerability and Pharmacokinetic Study of HEC68498 in Healthy Male and Female Subjects
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase I, Double-blind, Placebo-controlled, Single Oral Dose, Safety, Tolerability, and
      Pharmacokinetic Study, Incorporating an Evaluation of the Effect of Food on the
      Pharmacokinetics of HEC68498 in Healthy Male and Female Subjects
    

Detailed description: 
      Single-dose, sequential-group design incorporating a food-effect evaluation. Each subject
      will participate in 1 treatment period, except for Group 5, where each subject will
      participate in 2 treatment periods. In each group, 6 subjects will receive HEC68498 and 2
      subjects will receive placebo. Subjects in Group 5 will receive the same dose level of
      HEC68498 (or placebo) in both treatment periods. All doses will be administered either after
      an overnight fast of at least 8 hours or, for subjects in the food-effect evaluation,
      approximately 30 minutes after starting a standard high-fat breakfast. The first 2 subjects
      in each group will be dosed (1 subject receiving HEC68498 and 1 subject receiving placebo) 48
      hours prior to the remainder of the subjects. There will be a minimum of 7 days between dose
      escalations. The washout period for subjects in Group 5 will be determined following review
      of available PK data.
    

Intervention name(s): HEC 68498; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): HEC68498 is a potent,highly selective inhibitor of class 1 isozymes of phosphoinositide 3-kinase/mammalian(PI3K) and of the mammalian target of rapamycin (mTOR). It has shown good activity against fibrosis and inflammation in vitro and in vivo, with a lower effective dose and better efficacy than pirfenidone and nintedanib.; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Measuring Normal and Impaired Walking in Children Using the GAITRite Walkway
Condition: Typically Developing Children; Talipes Equino Varus; Paediatric Orthopaedic; Paediatric Neurological
MeSH terms: Talipes; Clubfoot; Equinus Deformity
Study type: Interventional

Summary: 
      Walking measurement in children is important but there are challenges associated with
      obtaining reliable repeatable data in a clinical setting that is meaningful and easy to
      interpret. This study set out to develop a new way to collect, record, and interpret walking
      data that is suitable for the clinical environment. Developmental percentile charts were
      selected as they are widely recognised and easily interpreted.
    

Detailed description: 
      The primary output of the main cohort of typically developing children is the developmental
      percentile charts.

      These will be then used to present the clinical longitudinal data against a normal backdrop
      of developmental changes in children.

      This has multiple clinical applications in many of the children assessed by physiotherapy at
      GOSH and more widely Nationally and internationally
    

Intervention name(s): Gait assessment using the GAITRIte walkway
Intervention type(s): Device
Intervention description(s): 10-20 walking assessment using the GAITRite walkway
Other intervention name(s): GAITRite
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: The tool used for this study has been and was used for routine patient care, but was a novel diagnostic assessment for the typically developing (norms) and some of the clinical groups included. The clinical groups were compared to norms, both had the same diagnostic assessment so there was no control group who did not have the assessment
Masking: None (Open Label)
Primary purpose: Diagnostic
Safety and Immunogenicity of Various Formulations of Live Attenuated Tetravalent Dengue Vaccine in Healthy US Adults
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 2

Summary: 
      This descriptive study will evaluate the safety and immunogenicity of 3 different
      formulations of the WRAIR dengue vaccine compared to a placebo.
    

Detailed description: 
      Subjects will be randomized into one of 4 groups. One group will receive a placebo vaccine
      and the others will receive one of 3 different dengue vaccine formations. Each subject will
      receive two doses six months apart. Study subjects who elect to participate in a mosquito
      transmissibility component of the study will undergo mosquito feedings during each of the two
      assigned follow-up visits after vaccine dose 1. All subjects will have 11 venipunctures
      during 11 visits (i.e., screening plus 10 study visits) over a period of nine months.

      A third (booster) dose of post transfection F17 or F19 will be administered approximately 5
      to 12 months after dose 2 to all subjects who received one of these formulation for their
      first two doses. Volunteers will return for a single visit 6 months after receiving their
      booster dose (long term follow-up)
    

Intervention name(s): Pre-transfection F17; Post-transfection F17; Post-transfection F19; Placebo
Intervention type(s): Biological; Biological; Biological; Other
Intervention description(s): Dengue tetravalent Vaccine F17 Pre transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection; Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.; Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.; Sterile solution of buffered water (0.9% NaCl), U.S. FDA accepted vaccine excipient, phenol red dye(phenolsulfonphthalein, used in vaccines as a pH indicator); 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
The Effect of Health Literacy Education
Condition: Health Literacy Level
Study type: Interventional

Summary: 
      The study was conducted with a parallel group randomized controlled experimental design to
      evaluate the effect of health literacy education given in early adolescence on the health
      literacy of adolescents. The population of the study consisted of 6th and 7th grade (12-13
      years old) students studying in a secondary school in Ankara. Power analysis was used to
      determine the sample size. A total of 80 adolescents who met the inclusion criteria were
      included in the sample.
    


Intervention name(s): Education
Intervention type(s): Other
Intervention description(s): four training sessions were applied to the intervention group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: health literacy; education; adolescent
Efficacy of Faviprevir in COVID-19 Treatment
Condition: COVID
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Faviprevir in COVID-19 treatment
    

Detailed description: 
      Clinical Study Evaluating the Efficacy of Faviprevir in COVID-19 treatment
    

Intervention name(s): Favipiravir; Chloroquine
Intervention type(s): Drug; Drug
Intervention description(s): Favipiravir; chloroquine oral tablets
Other intervention name(s): Faviprevir
Intervention MeSH terms: Chloroquine; Favipiravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Voluven® in Paediatric Patients
Condition: Cardiac Surgery; Cardiopulmonary Bypass
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare the clinical efficacy and safety of Voluven® and Human Albumin during
      elective open-heart surgery in pediatric patients.
    

Detailed description: 
      In the past, human albumin has been widely accepted as the therapeutic "gold standard" in
      paediatric volume replacement therapy because of the physiological hypoproteinemia in
      newborns and infants. In adult patients, artificial colloids such as hydroxyethyl starch have
      replaced human albumin as first choice in many settings. This study will compare the clinical
      efficacy and safety of HES 130/0.4 (6%) in normal saline vs. HSA 50g/L in volume replacement
      therapy during elective open-heart surgery in paediatric patients. The hypothesis of this
      study is to demonstrate that HES 130/0.4 (6%) and HSA 50g/L are equivalent regarding efficacy
      and provide comparable safety during elective open-heart surgery in paediatric patients 2 to
      12 years of age.
    

Intervention name(s): HES 130/0.4 (6%) in sodium chloride (Voluven®, solution for infusion), Human serum albumin (HSA 50g/L); Human serum albumin (HSA 50g/L)
Intervention type(s): Drug; Drug
Intervention description(s): Study medication will be given as part of the priming of the ECC and for plasma volume replacement after start of ECC up to the maximum dosage of 50 mL/kg body weight/day.; Human serum albumin (HSA 50g/L)
Other intervention name(s): Voluven®
Intervention MeSH terms: Hydroxyethyl Starch Derivatives
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phenotypes and Vascular Damage in Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      TOPDOCS is a prospective cohort study including COPD patients from currently six study
      centers in Switzerland. Patients with COPD GOLD stages I-IV will be enrolled and followed-up
      annually for at least 3 years. Yearly assessments will include a detailed patient history,
      quality of life and activity questionnaires, history of exacerbations, lung function,
      measurements of exercise capacity, measurements of vascular function, exhaled breath analysis
      and blood sampling. The overall objective of the project is to establish a meticulously
      characterized cohort of COPD patients living in Switzerland in order to allow high quality
      research on the pathogenesis, treatment and complications of COPD. The specific aim of the
      project is to determine clinically relevant COPD phenotypes and biological factors
      influencing vascular function in COPD patients.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with proven COPD, GOLD stages I-IV
      
Biospecimen description: 
      Blood samples
    
Keywords: COPD; Cardiovascular disease; Phenotypes
Influence of Transmission Season on Outcome of Treatment of Schistosoma Haematobium Infection in Mozambique
Condition: Hematuria; Hydronephrosis
MeSH terms: Schistosomiasis haematobia; Hematuria; Hydronephrosis
Study type: Interventional

Summary: 
      To assess the influence of seasonal variations in Schistosoma haematobium transmission on
      treatment outcome (morbidity and re-infection)
    

Detailed description: 
      General objective To provide knowledge about the influence of transmission season (high and
      low) on the outcome of treatment assessed by cure rate, re-infection rate, regression and
      reappearance of urinary tract morbidity rate after treatment in order to optimise
      praziquantel treatment strategies for morbidity control in urinary schistosomiasis.

      Specific objectives To determine the prevalence and intensity of Schistosoma haematobium
      infection before chemotherapy and compare cure rates and levels of re-infection after
      chemotherapy administered during high and low transmission seasons.

      To assess urinary tract morbidity due to Schistosoma haematobium by ultrasonography and
      compare the regression and reappearance of urinary tract pathology chemotherapy administered
      during high and low transmission seasons.

      To correlate morbidity determined by ultrasound with infection and morbidity parameters such
      as intensity of infection, micro- and macrohematuria, circulating cathodic antigen (CCA) in
      urine, proteinuria and leucocyturia and determine sensitivity, specificity and positive
      predictive values in relation to urinary tract morbidity.

      Study design The main research question concerning the influence of transmission season on
      treatment outcome will be addressed in a consecutive cohort study with two separate but
      comparable cohorts. The first cohort will be examined and treated with praziquantel during
      the season with high transmission, February/Mach (group A) and the second cohort will be
      examined and treated during the low transmission season, in July approximately 5 months later
      (group B). Each cohort will be examined before treatment and 2, 6 and 18 months after
      treatment.

      The study will be carried out in 4 primary schools; two from Machava J area and two from
      Costa do Sol area. The schools will be selected based on the following criteria: similar
      prevalence (> 50%) and intensity of S. haematobium infection; absence or very low levels of
      S. mansoni infection; a minimum of 2 classes (>35 pupils per class) at each level (3rd and
      4th level) and similar distribution of boys and girls.Examinations will include urine for
      parasitology and haematuria and ultrasonography of upper and lower urinary tract
    

Intervention name(s): praziquantel
Intervention type(s): Drug
Intervention MeSH terms: Praziquantel
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Schistosoma haematobium; haematuria; ultrasonography; Uganda; Vesical polyps
Long-term Effects of Arabinoxylans on Intestinal Barrier Function
Condition: Obesity; Overweight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The higher prevalence of overweight and obesity among the population contributes to increased
      incidences of chronic metabolic diseases. Obesity is considered a low-grade systemic
      inflammatory condition through 1) production of pro-inflammatory cytokines by adipose tissue
      and 2) alterations in intestinal microbiota composition and associated increase in intestinal
      permeability. Healthcare costs related to these diseases are rising; prevention or delay of
      onset of disorders associated with overweight is needed. Administration of wheat
      arabinoxylans (NAXUS), a non-digestible carbohydrate, may change the intestinal microbiota
      composition and have beneficial effects on gut epithelial barrier, especially on permeability
      and innate immune function.

      Objective: To assess the effects of NAXUS on intestinal barrier function, immune system
      performance and metabolic control. Prebiotic properties of NAXUS will be studied. Tolerance
      of the product in different doses will also be investigated.
    


Intervention name(s): NAXUS; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prebiotics; Intestinal permeability; Gut barrier function; Immunity