bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess Safety and Efficacy of Anti-Interleukin 6-receptor (IL6R) Nanobody in Rheumatoid Arthritis (RA) Patients
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether the ALX-0061, a Nanobody targeting the
      receptor for interleukin 6 (IL6R), is safe and effective after single or multiple
      administrations to patients with rheumatoid arthritis (RA). Patients will receive different
      single or multiple doses of either placebo or ALX-0061.
    


Intervention name(s): ALX-0061; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Intravenous administration, single dose (0.3-1-3-6-8 mg/kg) or multiple dose (Biologically effective dose, once every 4 weeks or once every 8 weeks, for 24 weeks); Intravenous administration, single dose or multiple dose (once every 4 weeks or once every 8 weeks, for 12(/24) weeks; switch to ALX-0061 in weeks 13-24 if no response after first 12 weeks)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Endoscopic Subureteral Injection for Vesicoureteral Reflux in Adults With Decreased Bladder Compliance
Condition: Vesicoureteral Reflux
MeSH terms: Gastroesophageal Reflux; Vesico-Ureteral Reflux
Study type: Interventional

Summary: 
      Endoscopic subureteral injection for vesicoureteral reflux has become an established
      alternative to ureter reimplantation in children. Some recent studies suggest that ESI can be
      also a primary treatment option for VUR in adults. However, the experience with ESI in adults
      who have VUR associated with decreased bladder compliance is limited. We evaluated the
      efficacy of endoscopic subureteral injection treatment for vesicoureteral reflux in adults
      with decreased bladder compliance.
    


Intervention name(s): Endoscopic subureteric injection
Intervention type(s): Procedure
Intervention description(s): Endoscopic subureteric injection for the treatment of vesicoureteral reflux using variable materials (polydimethylsiloxane, collagen, and dextranomer/hyaluronic acid copolymer)
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vesicoureteral reflux; low compliant bladder
Digestive and Nutritional Effects of Probiotics Supplementation in Premature Newborns
Condition: Duration of Parenteral Nutrition
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Symbiotic interaction between probiotics ("Living alimentary microbials supplemental,
      affecting positively host by improving intestinal microbial equilibrium" (Fuller, 1989)) and
      human digestive tract was amply experimented and seems to be an interesting solution to
      orientate neonates digestive flora. Many studies showed a probant efficiency of probiotic
      supplementation in neonates on ECUN, despite abnormally high ECUN incidence in control group.
      Nevertheless, our aim is to test clinical efficiency of two new probiotics strains.
      Bifidobacterium Longum and Lactobacillus GG on Oral Nutrition (volume at Day 14 and Day 21)
      and safety (Adverse Events) in very premature babies.
    


Intervention name(s): Probiotics supplementation until weight reaches 1800g (Bifidobacterium Longum and Lactobacillus GG )
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Digestive and Nutritional Effects; Safety and Growth; Feeding Tolerance
Compliance to the Treatment With GRAZAX® Tablets in Patients With Seasonal Grass Pollen Rhinoconjunctivitis
Condition: Allergic Rhinitis; Grass Allergy
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      Adherence to treatment is crucial to the efficacy of sublingual immunotherapy of allergic
      diseases. GRAZAX® is a registered drug in Europe, with established efficacy in the treatment
      of allergic rhinitis, which has to be taken daily by patients. This study was aimed to
      establish if a device with the characteristics of a mechanical dispenser (Memozax®) could
      improve adherence to treatment in subjects with hay fever due to allergy to grass
    


Intervention name(s): Electronic compliance device (Memozax®)
Intervention type(s): Device
Intervention description(s): An electronic compliance device is distributed to patients allocated to the active arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: specific allergen immunotherapy; sublingual immunotherapy; allergen tablets; compliance; electronic compliance device
Study of the Anti-FGF23 Antibody, Burosumab, in Adults With XLH
Condition: X-linked Hypophosphatemia
MeSH terms: Familial Hypophosphatemic Rickets; Hypophosphatemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This is phase 3b open-label, international, multicenter study to continue to monitor the
      long-term safety and efficacy of burosumab in adult patients with XLH that participated in
      previous clinical trials with burosumab (UX023-CL303 / UX023-CL304).
    

Detailed description: 
      XLH is a rare, genetic disorder that is serious, chronically debilitating and represents an
      unmet medical need. XLH is the most common inherited form of rickets and the most common
      inherited defect in renal tubular phosphate transport. XLH is transmitted as an X-linked
      dominant disorder. Mutations resulting in the loss of function of PHEX form the genetic basis
      for XLH. More than 300 different PHEX gene mutations have been identified in patients with
      XLH (PHEXdb); however, few definitive correlations have been observed between specific
      mutations and phenotypic severity.

      Patients with XLH have hypophosphatemia due to excessive serum FGF23 levels. FGF23 reduces
      serum phosphorus levels by two distinct mechanisms of action. The primary mechanism is to
      inhibit phosphate reabsorption in the proximal tubule of the kidney. The secondary mechanism
      is to decrease phosphate absorption by the small intestine through the inhibition of
      1,25(OH)2D production in the kidney.

      Burosumab has the potential to block or reduce FGF23 action and improve phosphate homeostasis
      in XLH patients. Burosumab binds the amino-terminal domain of FGF23 that interacts with the
      FGF-binding portion of the combination FGFR1/Klotho receptor, preventing FGF23 from binding
      to and signaling from its receptor. Both intact and fragmented FGF23 polypeptides are
      immunoprecipitated with burosumab. By inhibiting FGF23, burosumab restores tubular
      reabsorption of phosphate (as measured by the ratio of renal tubular maximum reabsorption
      rate of phosphate to glomerular filtration rate [TmP/GFR]) from the kidney and increases the
      production of 1,25(OH)2D that also enhances intestinal absorption of phosphate. The dual
      action on kidney reabsorption and intestinal absorption improves serum phosphorus levels,
      which is expected to improve bone mineralization and reduce the diverse bone and non-bone
      manifestations associated with hypophosphatemia in XLH patients.
    

Intervention name(s): Burosumab
Intervention type(s): Drug
Intervention description(s): Burosumab is a sterile, clear, colourless and preservative free solution supplied in single-use 5ml vials containing 1mL of burosumab at a concentration of 30mg/mL
Other intervention name(s): KRN23; Crysvita
Intervention model: Single Group Assignment
Intervention model description: Open-label, international, multicenter
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Crysvita; Burosumab; X-linked Hypophosphatemia (XLH); PHEX Gene Mutation; PHEXdb
Bioequivalence Study for Terbinafine 250 mg
Condition: Mycoses
MeSH terms: Mycoses
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to confirm if two formulations of terbinafine (tablets) are
      bioequivalent.

      Test product was Xilatril® 250 mg (Laboratorios Dermatológicos Darier) and reference product
      Lamisil® 250 mg (Novartis). One tablet was the single dosage.

      The study was prospective, open-label, randomized, crossover, single dose, with 02
      treatments, 02 sequences and 02 periods, under fasting conditions.

      The population was composed of 30 healthy volunteers, both genders, adults between 18-50
      years.

      The comparative bioavailability of the two formulations was evaluated based in statistical
      comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations
      in blood.
    


Intervention name(s): Terbinafine 250 mg; Terbinafine 250 mg
Intervention type(s): Drug; Drug
Intervention description(s): Test product; Reference product
Other intervention name(s): Xilatril® is a registered trademark of Laboratorios Dermatológicos Darier; Lamisil® is a registered trademark of Novartis
Intervention MeSH terms: Terbinafine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Mexico; terbinafine; mycoses; pharmacokinetics
Retapamulin Microdialysis Feasibility Study
Condition: Skin Infections, Bacterial
MeSH terms: Cellulitis; Skin Diseases, Infectious; Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This feasibility study will allow for the determination of the in vivo recovery and time of
      dialysis to optimize a future thorough microdialysis study. This is a single session, open
      label study to evaluate the feasibility of microdialysis for Retapamulin in healthy subjects.
      Three healthy subjects will be enrolled and complete the study procedures. Subjects will be
      admitted to the research unit on Day 1 and three microdialysis probes will be placed in the
      thigh of each subject prior to the start of the microdialysis procedure. After normal saline
      solution infusion for 30 minutes, a Retapamulin solution will be infused for 90 minutes.
      Saline perfusion will occur during the washout period. Microdialysis sampling will be done
      for 30 minutes (during the last 30 minutes of drug perfusion) and dialysate sample collection
      will continue every 30 minutes for 4 hours. The approximate duration of study including
      follow-up is 4 days.
    


Intervention name(s): Retapamulin Microdialysis
Intervention type(s): Drug
Intervention description(s): After a 30 minutes equilibration period of the microdialysis procedure/infusion with normal saline solution, 50nanogram (ng)/mL Retapamulin injectable solution will be infused at a flow rate of 1.5 microliter/minute over a period of 90 minutes. The total dose perfused for each of the 3 microdialysis tubes will be 6.75ng.
Intervention MeSH terms: Retapamulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Penetration; Antibiotic; Microdialysis; Formulation Pharmacokinetics; Feasibility
Effects of a Dietary Fiber on Fecal Microbiota and Metabolism
Condition: Focus of the Study is on Gut Health
Study type: Interventional

Summary: 
      The purpose of the study is to examine how a dietary fiber affects metabolism in healthy
      overweight and obese adults. The fiber will be added to foods that participants will consume
      for two, three-week periods. The fiber will be given in two doses -- 15 g per day during one
      period, and 30 g per day in the other. In another three-week period, they will consume the
      same foods, but with no fiber added. Major outcomes will include fermentability of the fiber,
      as assessed by measurement of breath hydrogen, as well as shifts in fecal bacteria. The
      caloric value of the fiber will be determined and metabolic measures related to blood glucose
      control and inflammation will also be taken.
    


Intervention name(s): Dietary Fiber
Intervention type(s): Dietary Supplement
Intervention description(s): Dietary fiber will be added to study foods
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
A Research Study to Look at How Insulin 287 and Semaglutide Work in the Body of People With Type 2 Diabetes When Taken Alone or Together
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will look at how insulin 287 and semaglutide work in the body, both when given
      alone or together. This study will look at the way insulin 287 and semaglutide reach and stay
      in participants' blood after injection when given alone or together. Participants will get 3
      study medicines at 3 different time points: 1) a combination of semaglutide plus insulin 287,
      2) insulin 287 alone and 3) semaglutide alone. The order in which participants get them is
      decided by chance. Participants will get all medicines as an injection under the skin in the
      thigh. The injections will be done by study staff. The time between injections is 6 to 9
      weeks. The study will last for about 19 to 32 weeks in total.
    


Intervention name(s): NNC0148-0287sema; Semaglutide; NNC0148-0287
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Study staff will inject NNC0148-0287sema, 175unit (U)/0.5 mg in the morning after fasting under the skin of participants' thigh using a needle and a pen.; Study staff will inject semaglutide, 0.5 mg alone in the morning after fasting under the skin of participants' thigh using a needle and a pen.; Study staff will inject insulin 287 (NNC0148-0287), 175U alone in the morning after fasting under the skin of participants' thigh using a needle and a pen.
Other intervention name(s): Ozempic®
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a three-period cross-over trial. The treatments to be used are: Treatment A: insulin 287, Treatment B: semaglutide, and Treatment C: NNC0148-0287sema. The subjects will be randomised to one of the six treatment sequences in the trial: 1) ABC, 2) ACB, 3) BAC, 4) BCA, 5) CAB, and 6) CBA. The trial includes a screening visit followed by three 5 -week periods with pharmacokinetic sampling after single dose administration. The dose periods are separated by a 1-4 week washout period (from last pharmacokinetic sampling to next dosing). The follow-up period is 1-4 weeks after last pharmacokinetic sampling in period 3 (i.e. 6 to 9 weeks after last trial product administration). The total trial duration for the individual subjects participating in the trial will be 19 to 32 weeks (including follow-up), depending on individual visit schedules.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Eccentric Training Versus Active Release Technique On Quadriceps In Patients With Dynamic Hip Screw
Condition: Hip Surgery
Study type: Interventional

Summary: 
      This study will compare the effects of Eccentric training and Strength training with priory
      applied Active Release Technique on Quadriceps muscle in post operative patients of Dynamic
      Hip screw. Participants would be equally divided into two groups each receiving specific type
      of protocol besides standard post operative protocol of Dynamic Hip screw
    

Detailed description: 
      The study is Randomized Control Trial, being conducted at Fauji Foundation Hospital
      Rawalpindi .This study will compare the effects of two techniques addressing the contractile
      as well as non-contractile element of Quadriceps in early phase of Rehabilitation.

      Sample size of 18 was calculated using software Epitool with 95% confidence interval and 80%
      power. Individuals of selected population will be randomly allocated as 9 in Eccentric group
      and 9 in Active Release Technique group by sealed enveloped method.
    

Intervention name(s): Eccentric Training; Active Release Technique
Intervention type(s): Other; Other
Intervention description(s): First session will be performed 24 hours after pre-training tests i.e. on 4th post- operative day and subsequent sessions will be performed with lapse of 48 hours. During pre-testing, weight for the eccentric training will be determined using Standardized Brzycki formulas for lower limb. Participants will perform one set of 10 repetitions with selected weight. Intensity will be increased every week by decreasing the time of performance. Volume will be increased by increasing one set after two weeks. Eccentric training will be performed in sitting position on dynamic constant external resistance equipment.After session, patient will perform strengthening of quadriceps muscle as per clinical practice guidelines of National Health Service (UK).; Isometric Quadriceps' contractions against therapist's resistance lasting for 10 seconds will be performed by the patient in inner range of knee extension and after relaxing; actively perform maximum full knee flexion. Patient will perform extension at knee joint again; when reaches the innermost range, therapist will apply pressure on deep fascia either through knuckles/fingers or forearm in the direction towards the hip joint and patient is asked to perform knee flexion simultaneously. The procedure is applied onto vastus lateralis, rectus femoris and vastus intermedialis thrice in a session. After session, patient will perform strengthening of quadriceps muscle as per clinical practice guidelines of National Health Service (UK).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There will be two treatment groups of participants, One group will be trained on eccentric graded protocol whereas the other will receive active release technique of quadriceps.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Eccentric training; Active Release Technique
The Association Between Pulmonary Function Tests and Difficult Airway
Condition: Airway Obstruction
MeSH terms: Airway Obstruction
Study type: Interventional

Summary: 
      The airflow moving from mouth to the lungs, which can be measured by pulmonary function
      tests, may be affected by the anatomic disorders of the upper airway. Difficult airway can be
      considered as the anatomic disorder of the upper airway as well. Therefore, there can be a
      relationship between difficult airway and pulmonary function tests. The purpose of this study
      is to elucidate the association between the pulmonary function tests and difficult airway.
    

Detailed description: 
      After approval of the Gaziosmanpasa University Clinical Trials Ethics Committee, patients
      those admitted to the anesthesiology outpatient unit will informed about the study. And
      pulmonary function tests by using Spirodoc® will be performed to those willing to participate
      in the study. Measurements of the pulmonary function tests, and measurements belong to
      difficult airway will be recorded.

      In the operating theatre, after induction of anesthesia, the difficult intubation
      measurements will be recorded.

      Normality and variance will be tested using One Sample Kolmogorov-Smirnov test, skewness,
      kurtosis and histograms for each variable. Quantitative data will present as means and
      standard deviation, and qualitative data as frequency and percentage. Depending on these
      results, Spearman's correlation analysis will perform to show the association between
      pulmonary function tests and difficult airway measurements. Analyses were conducted using the
      Statistical Package for Social Sciences program (SPSS Inc., Chicago, IL), version 20.0.
      Statistical significance for all analyses was set at p < 0.05.
    

Intervention name(s): Spirodoc
Intervention type(s): Device
Intervention description(s): A device to detect the physical condition of the lungs
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Airway Management; intubation; pulmonary function test
Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial)
Condition: Depressive Disorder; Depression; Depressive Disorder, Major; Mood Disorders; Mental Disorders
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Mental Disorders; Mood Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in
      addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major
      Depressive Disorder (MDD)
    


Intervention name(s): OPC-34712; Escitalopram; Fluoxetine; Paroxetine CR; Sertraline; Duloxetine; Venlafaxine XR
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tablet; Tablet; Capsule; Controlled-release tablets; Tablets; Delayed-release capsules; Extended-release capsules
Other intervention name(s): Lexapro; Prozac; Paxil CR; Zoloft; Cymbalta; Effexor XR
Intervention MeSH terms: Duloxetine Hydrochloride; Fluoxetine; Paroxetine; Venlafaxine Hydrochloride; Sertraline; Escitalopram
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: OPC-34712; brexpiprazole; Major Depressive Disorder; Adjunctive Treatment
The Hybrid Combination of CCTA and SPECT and CAG for Evaluation Prognosis of CAD: an Observational Follow-up Study
Condition: Coronary Disease
MeSH terms: Coronary Disease
Study type: Observational

Summary: 
      A total of 550 patients with stable angina (40-70% stenosis) tested by coronary CT
      angiography (CCTA) and single photon emission computed tomography (SPECT) and coronary
      angiography (CAG) within 3 months were retrospectively recruited from 2005 to 2015 and follow
      up to 5 years. A new hybrid software was used to analysis the image data.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients who were suspected coronary artery disease and underwent CCTA, SPECT and CAG
        within 3 months from 2005 to 2015.
      
Keywords: SPECT; CCTA; CAG; Hybrid
Low Volume PEG With Low Residue Test Meals Versus High Volume Split-dose PEG Bowel Preparation
Condition: Bowel Preparation; Colonoscopy
Study type: Interventional
Phase: Phase 3

Summary: 
      Morning only low volume PEG with low reside meals may enhance patient tolerability and have
      similar bowel cleansing efficacy compared to standard method using high volume split-dose PEG
      with standard diet.
    

Detailed description: 
      We aimed to evaluate the efficacy and tolerability of bowel preparation protocols with low
      volume PEG and low residue meals PEG compared to conventional high volume (4L) split-dose and
      standard diet.

      Entry criteria: Entry criteria: Adult outpatients and inpatients (18-85 years of age) who
      undergo colonoscopy for screening, cancer surveillance or with gastrointestinal symptoms,
      other symptoms

      Primary Outcome: Quality of bowel preparation (Ottawa scale) Secondary Outcome: Tolerability
      (preparation completion, side effect), acceptance, willingness
    

Intervention name(s): Low volume PEG; high volume PEG
Intervention type(s): Drug; Drug
Intervention description(s): low volume polyethylene glycol 2 liter one time; high volume polyethylene glycol 4 lilter split-dosing 2L/2L two times
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: colonoscopy; bowel preparation; polyethylene glycol; low residue meal