bioihbjkbjnl/mcl2 huggingface dataset:
Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology
Condition: Hydronephrosis; Neurogenic Bladder
MeSH terms: Urinary Bladder, Neurogenic; Hydronephrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective was to determine efficacy of Alfuzosin in the treatment of children and
      adolescents 2-16 years of age with newly diagnosed or progressive hydronephrosis due to
      elevated detrusor Leak Point Pressure [LPP] of neuropathic etiology.

      Secondary objectives were:

        -  To investigate the safety and tolerability of alfuzosin 0.2 mg/kg/day in children and
           adolescents,

        -  To investigate the number of Urinary Tract Infection (UTI) episodes,

        -  To investigate the pharmacokinetics of Alfuzosin (population kinetics).
    

Detailed description: 
      The study consisted of 2 phases:

        -  a 12-week efficacy phase then,

        -  a 40-week safety extension phase.

      All eligible subjects received alfuzosin 0.2 mg/kg/day. The formulation and the frequency was
      assigned by Interactive Voice Response System (IVRS) according to age group and ability to
      swallow tablets.

      Patients who completed the 12-week open-label treatment period were offered to continue in
      the 40-week open-label safety extension study. The treatment was the same as in the 12-week
      efficacy phase.

      All patients had a one-week follow-up period after the last dose intake.
    

Intervention name(s): Alfuzosin
Intervention type(s): Drug
Intervention description(s): Dose: 0.2 mg/kg/day
Route: oral
Other intervention name(s): SL770499
Intervention MeSH terms: Alfuzosin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: child; bladder; neuropathic; alpha blockers
Stem Cell Translpantation in Multiple Myeloma
Condition: Multiple Myeloma
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether autologous transplantation (using the
      patient's own stem cells from the blood), followed by non-myeloablative (i.e. less intense)
      allogeneic transplantation (where the blood stem cells from a sibling donor are used for the
      transplantation) improves the outcome in patients with newly diagnosed multiple myeloma.
    

Detailed description: 
      This trial includes a natural (no available HLA-identical sibling donor) control arm.
      Patients with newly diagnosed multiple myeloma without a sibling are initially treated with
      conventional chemotherapy followed by conventional single or double autologous transplant
      (PBSCT). Data from this group is used as part of the control group.

      Eligible patients with one or more sibling are offered to participate in the main trial arm.
      Those who decline are asked to consider taking part in the control group (autograft only).

      Patients consenting to participate in the main study first receive the PBSCT, followed by the
      HLA-matched non-myeloablative allograft (matched for HLA -A, -B, -C, -DRB1).

      All study patients receive four to six cycles of VAD (or alternative regimens specified in
      protocol) before PBSCT as first line treatment. Study entry starts at the time of starting
      conditioning for autologous transplantation. The search for an identical sibling donor begins
      as soon as the patient has consented to participate in the study.

      The allograft is performed when the patient has restored their marrow function but no earlier
      than 3 months following PBSCT.

      The aim is to demonstrate a difference in outcome (progression free survival, transplant
      related mortality, relapse rate, and survival).
    

Intervention name(s): HLA Matched allogeneic transplant
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients with an HLA-identical sibling donor were allocated to the auto-allo arm (n = 108) and patients without a matched sibling donor were allocated to the auto arm (n = 249)
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: myeloma; HLA-matched; autologous; allogeneic; transplant
PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon
Condition: Colonic Diseases
MeSH terms: Colonic Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      To see if PillCam COLON will demonstrate diagnostic yield >80% in detecting significant
      colonic pathologies when compared to colonoscopy in the target population.
    

Detailed description: 
      The development and introduction of a specially designed, customized colon capsule combined
      with a dedicated capsule colonoscopy procedure protocol will allow for more efficient
      evaluation of the colonic mucosa. This is expected to improve the capability of the Given®
      Diagnostic System to detect colonic pathologies and to serve as a diagnostic and screening
      tool for colonic disease.

      This study is designed to compare capsule colonoscopy and colonoscopy procedures in detecting
      colon abnormalities. Note that the physician performing the capsule endoscopy and reading the
      capsule videos and the physician performing the colonoscopy were unaware of each other's
      findings until completion of the examinations and reports (assessor-blind).
    

Intervention name(s): PillCam COLON; Standard colonoscopy
Intervention type(s): Device; Procedure
Intervention description(s): The PillCam COLON capsule is an ingestible capsule equipped with an endoscope that has two imagers, enabling it to acquire video images from both ends. the device measures 31 by 11 mm and acquires images at a rate of 4 frames per second. Recording and downloading of data are similar those of the data for small-bowel capsule endoscopy.; Standard colonoscopy was the standard against which capsule endoscopy was compared,and it was performed after capsule endoscopy (after capsule excretion or at least 10 hours after capsule ingestion, whichever came first), on either the same day as ingestion or the next morning.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Suspected colonic disease; Known colonic disease
Image-guided Pleural Biopsy or Medical Thoracosocopy in Diagnosis of Pleural Disease
Condition: Diagnosis of Pleural Diseases
MeSH terms: Pleural Diseases; Disease
Study type: Interventional

Summary: 
      Pleural diseases can occur due to numerous pathological conditions. The increasing prevalence
      of etiologic causes and aging population worldwide will make pleural diseases a growing
      problem in the coming years. As a result of this increase, the need for diagnostic
      investigations is also increasing. In recent years, the use of image-guided needle biopsies
      under ultrasound (US) or computed tomography (CT) and the increasing use of medical
      thoracoscopy (MT) have significantly increased the accuracy of diagnosis of pleural disease.
      There is not yet a generally accepted algorithm for invasive diagnosis of pleural disease,
      widely used in clinics, that determines which method should be used in which patient. It
      would be necessary and valuable to develop an algorithm based on imaging findings in
      particular to improve the diagnostic accuracy, safety, and cost of the procedure. The
      investigators aimed to test the algorithm in an interventional study to increase the level of
      evidence in this study.
    

Detailed description: 
      No consensus exists regarding which biopsy methods are appropriate for specific procedures.
      In this randomized prospective study, the investigators aimed to compare image guided -
      pleural biopsy using an Abrams' needle (IG-ANPB) with medical thoracoscopy (MT) according to
      the CT findings of the patients concerning both diagnostic yield and safety.

      Between May 2017 and March 2022, 228 patients with exudative pleural effusion who the
      cytological analysis could not diagnose were included. All patients were separated into two
      groups regarding the CT findings: Only pleural effusion or pleural effusion with pleural
      thickening/lesion. In each group, the patients were randomized to either underwent IG-ANPB or
      underwent MT. The two groups were compared in terms of diagnostic sensitivity, accuracy, and
      complications.
    

Intervention name(s): Abrams' needle pleural biopsy (IG-ANPB) versus medical thoracoscopy in the diagnosis of pleural diseases.
Intervention type(s): Procedure
Intervention description(s): We compare the diagnostic efficacy and safety of imaging-guided Abrams needle biopsy with medical thoracoscopy.
Other intervention name(s): A diagnostic algorithm for pleural diseases.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized prospective
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Pleura; Thoracoscopy; Pleural needle biopsy; Diagnosis
Exhaled Nitric Oxide as a Biomarker of Disease Activity in Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Observational

Summary: 
      There is currently no reliable, noninvasive biomarker for eosinophilic esophagitis (EoE), a
      chronic allergic diseases characterized by significant infiltration of eosinophils in the
      esophagus. Because eosinophils release nitric oxide, levels of exhaled nitric oxide (FeNO)
      are used routinely for guiding treatment in subsets of patients with asthma. FeNO levels are
      also elevated in immunological diseases that do not involve the airways. The investigators
      hypothesize that patients with EoE have elevated nitric oxide concentration in their exhaled
      breath and that changes in FeNO levels could be used to measure disease activity. The
      objective of this study is to determine the feasibility of using FeNO as a noninvasive
      surrogate marker for EoE disease activity. The investigators propose to measure serial
      exhaled nitric oxide (FeNO) levels on a group of patients with confirmed EoE, before, during
      and after the course of topical corticosteroid therapy to determine whether the level
      declines from pre-treatment level in individual patients.
    


Intervention name(s): NIOX MINO® Airway Inflammation Monitor
Intervention type(s): Device
Intervention description(s): We will measure exhaled nitric oxide of patients with eosinophilic esophagitis pre-, during and post- treatment at pre-defined time intervals.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Gastroenterology outpatient clinic
      
Keywords: Exhaled nitric oxide; Eosinophilic esophagitis
The Genetics Behind Vitamin D Status (VitDgen)
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional

Summary: 
      The overall purpose of the study is to investigate whether there is a relationship between 26
      different single nucleotide polymorphisms (SNPs) in the vitamin D pathway, ultraviolet B
      (UV-B) irradiation of the skin and vitamin D status.

      The hypothesis is that vitamin D status are influated by different genetic genotypes in the
      vitamin D pathway.
    

Detailed description: 
      In this study approximately 80 participants (over 18 years) are included. All the
      participants has previously participated in the VitmaD intervention study (NCT01184716) .

      Participants will in total receive 4 times UV-B irradiation (3 SED) with two day apart each
      time, to stimulate vitamin D production in the skin. The participants skintype will be
      measured. The study starts in January 2013 and runs to the end of Marts 2013. During this
      winter period, it is in Denmark not possible to produce vitamin D in the skin through
      sunlight exposure.
    

Intervention name(s): VitDgen
Intervention type(s): Genetic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: SNPs; vitamin D; Vitamin D status; UVB irradiation; genetics
Evaluation of the Effect of Sodium Bicarbonate Water on Blood Pressure in Normotensive Subjects
Condition: Blood Pressure
Study type: Interventional

Summary: 
      ROX_TENSIO18 is a randomised cross-over trial and the main objective is to evaluate the
      effect of daily consumption of sodium bicarbonate water for 15 days on blood pressure.

      Secondary objective are:

        -  Evaluation of the effect of daily consumption of sodium bicarbonate water on total salt
           intake

        -  Evaluation on blood pressure of the usual food groups that are the strongest
           contributors of salt intake.
    

Detailed description: 
      Volunteers are normotensive subjects divided into two equivalent groups. Group A subjects
      will begin their first 15-day period with the consumption of St-Yorre mineral water.

      Group B will begin the first 15-day period by drinking tap water. After a washout period of
      15 days, each group alternates with a new period of 15 days of water consumption monitoring:
      tap water for group A and mineral water St-Yorre for group B.

      For each period salt intake and blood pressure are measured.Three-day food records are also
      performed for both 15-days periods.
    

Intervention name(s): Sodium bicarbonate-rich mineral water
Intervention type(s): Other
Intervention description(s): St-Yorre, a sodium bicarbonate-rich mineral water, is a commercial mineral water that contains 4368 mg/l sodium bicarbonate. The study intends to evaluate the effect on blood pressure of the sodium bicarbonate intake due to this mineral water consumption.
Other intervention name(s): St-Yorre mineral water
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Group A subjects: first 15-day period drinking a sodium bicarbonate-rich mineral water Group B subjects: first 15-day period drinking tap water Washout period of 15 days Group A subjects: last 15-day period drinking tap water Group B subjects: last 15-day period drinking a Sodium bicarbonate-rich mineral water
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Nutrition; Blood pressure; Sodium bicarbonate
Pipamperone/Citalopram (PipCit)Versus Citalopram in the Treatment of Major Depressive Disorder(MDD)
Condition: Depression
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to demonstrate whether the addition of pipamperone 5 mg twice daily
      (bd) to citalopram, 40 mg daily in patients suffering from MDD will improve the efficacy of
      citalopram 40 mg in these patients.

      Secondary objectives are to demonstrate whether the addition of pipamperone 5 mg twice daily
      (bd) to citalopram, 40 mg daily in patients suffering from MDD:

        1. Will increase the rate of resolution of symptoms with citalopram 40 mg.

        2. Show the combined product to be safe and tolerable.

      Patients are scheduled to receive study medication for eight weeks and a final follow-up
      check will be carried out 28 days after completing the study.

      All patients will receive active citalopram from baseline and will be randomised to receive
      either active pipamperone or a placebo equivalent for eight weeks during which time they will
      attend for 6 study visits.
    


Intervention name(s): Citalopram + Pipamperone; Citalopram
Intervention type(s): Drug; Drug
Intervention description(s): Citalopram, 40 mg daily, 8 weeks Pipamperone, 5 mg twice daily, 8 weeks; Citalopram, 40 mg daily, 8 weeks Placebo, dummy, twice a day, 8 weeks
Intervention MeSH terms: Dexetimide; Pipamperone; Citalopram; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lost of interest, Depressed Mood
Development and Validation of a Multi-Mineral Fluoride Mouthrinse
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary goals of this project are to determine the anticaries benefits of a prototype
      multi-mineral mouthrinse containing 225 ppm fluoride and 30 ppm of a Ca through the
      remineralization of enamel white-spots (non-cavitated lesions). The selection of patients
      with pre-existing white-spot lesions will permit an opportunity to evaluate the efficacy of
      the multi-mineral mouthrinse in reminerzalizing and/or inhibiting progression of enamel
      white-spot lesions.
    


Intervention name(s): Fluoride; Fluoride
Intervention type(s): Drug; Drug
Intervention description(s): Over-the-counter level of fluoride (226 ppm) in a fluoride mouthrinse; FDA considers fluoride in a rinse formulation as a 'drug'; dosage is 10 mL per treatment.; Over-the-counter level of fluoride (226 ppm) plus calcium (30 ppm) in a fluoride mouthrinse; FDA considers fluoride in a rinse formulation as a 'drug'; dosage is 10 mL per treatment.
Other intervention name(s): ACT fluoride mouthrinse; New mouthrinse
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: remineraliation; pre-existing white-spot (non-cavitated) enamel lesions
TNF Polymorphism and Implantation Rate
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      Do TNF-308 and -238 polymorphisms impact the embryo implantation rate after in vitro
      fertilization (IVF) in women without female infertility factor ?
    

Detailed description: 
      This study was performed in order to verify whether TNF-308 allele was associated with a
      higher implantation rate and multiple pregnancy rates in women without known infertility
      factors after ovarian hyperstimulation with exogenous FSH for IVF
    

Intervention name(s): biological and ultrasound test
Intervention type(s): Procedure
Intervention description(s): biological and ultrasound test 20 days after implantation in order to see the implantation rate
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women undergoing intracytoplasmic sperm injection (ICSI) due to male infertility factors
Corticosteroid Injection Combined With Cataract Surgery in Diabetic Eyes.
Condition: Diabete Type 2; Cataract; Triamcinolone Acetonide; Intravitreal Injection
MeSH terms: Cataract; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators aim in this study to investigate the effect of intravitreal triamcinolone
      acetonide injection on the development of macular edema and the progression of diabetic
      retinopathy. Whether this injection hastens cataract surgery results or not. The
      investigators will categorize the participants into two groups: the case group who will
      receive the injection at the end of the surgery, and the control group who will have routine
      cataract surgery with no extra injections.
    

Detailed description: 
      Cataract and diabetic retinopathy (DR) represent two of the top five leading causes of global
      impaired vision and blindness according to the WHO. Higher incidence and faster cataract
      progression are well-established in diabetic patients, especially those with higher glycated
      hemoglobin values. Further, it is estimated that up to 20% of all cataract surgery is
      performed on diabetic patients. The investigators aim in this study to contribute to
      investigating the efficacy of triamcinolone acetonide injection at the end of
      phacoemulsification surgery in patients with type 2 diabetes in comparison with the standard
      phacoemulsification surgery: whether it blunts the initiation as well as the progression of
      diabetic macular edema and diabetic retinopathy, and improves visual outcomes. Besides, The
      investigators aim to evaluate the consequences and safety of the injection.
    

Intervention name(s): Triamcinolone Acetonide
Intervention type(s): Drug
Intervention description(s): Intravitreal injection of 4 mg/0.1 mL preservative-free triamcinolone acetonide at the end of phacoemulsification surgery will be injected at 3.5 mm inferolateral and posterior to the limbus.
Other intervention name(s): Kenalog
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective randomized single-blinded clinical trial
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: diabetes; phacoemulsification; intravitreal; triamcinolone acetonide; diabetic retinopathy; central subfield macular thickness; CSMT; CDVA; IOP
A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Atorvastatin in Healthy Volunteers
Condition: Healthy; Pharmacokinetics of Atorvastatin
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to assess the effect of ASP1585 on pharmacokinetics of atorvastatin in 2x2
      crossover method.
    


Intervention name(s): ASP1585; atorvastatin
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Lipitor
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: ASP1585; Drug-drug interaction; Atorvastatin; Healthy volunteer
TD-1211 IV/Oral Mass Balance Study
Condition: OIC
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine TD-1211 is processed by the body.
    

Detailed description: 
      This study will provide information regarding the metabolic pathway of TD 1211, the need for
      evaluation of potential drug-drug interactions, the need for studies in special populations
      and the absolute oral bioavailability of TD-1211. The administration of radiolabeled drug is
      necessary to fully characterize the rates and routes of elimination of TD 1211, providing
      further quantitative information on the disposition of TD 1211. The results from this study
      will allow a more comprehensive comparison between animal and human routes of elimination and
      metabolic profiles of TD 1211.
    

Intervention name(s): TD-1211 IV [C14]; TD-1211 PO [C14]
Intervention type(s): Drug; Drug
Other intervention name(s): TD-1211; TD-1211
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OIC; Opioid Induced Constipation; Constipation