bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Multiple Doses of ALXN1210 in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluated the safety and tolerability of multiple doses of ALXN1210 (400 and 800
      milligrams [mg]) following intravenous (IV) administration to healthy participants.
    

Detailed description: 
      Participants were divided into 2 cohorts and were randomly assigned in a 3:1 ratio to receive
      IV ALXN1210 or placebo. Participants in Cohort 1 received 5 IV doses of 400 mg of ALXN1210 or
      placebo administered every 28 days. To determine if dose continuation and dose escalation to
      Cohort 2 should occur, the Safety Review Committee conducted a blinded review of the
      available safety data after Day 15 of the second dose of the last participant in Cohort 1.
      Participants in Cohort 2 received 5 doses of 400 mg of ALXN1210 or placebo and 5 IV doses of
      800 mg of ALXN1210 or placebo administered intravenously every 28 days. Safety, PK, PD, and
      immunogenicity assessments were performed during the Follow-up Period after the last dose.
    

Intervention name(s): ALXN1210; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ALXN1210 was administered by IV infusion over 5 periods, 1 dose per period: Period 1, induction; Periods 2-5, maintenance. Participants received a total of 5 doses of 400 or 800 mg, each administered every 28 days.; Placebo was administered by IV infusion over 5 periods, 1 dose per period. Participants received the same volume and infusion rate as specified for each ALXN1210 dose (400 or 800 mg).
Other intervention name(s): Ultomiris; Ravulizumab
Intervention MeSH terms: Ravulizumab
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: ALXN1210; Pharmacokinetics; Pharmacodynamics
Complexity & Distraction in LBP
Condition: Chronic Low Back Pain; Gait; Motor Activity
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Motor control, notably expressed through the complexity of the variability of the locomotor
      pattern, is disturbed at the central level by an apprehension of pain and movement, more than
      pain itself (or by biomechanical / structural damage of the spine) in chronic low back pain
      (cLBP) patients.

      The aim of this study is to control that variability is reduced during gait at comfortable
      level and to test that distraction can reduce pain avoidance and therefore increase
      variability in cLBP patients.
    


Intervention name(s): walk test
Intervention type(s): Behavioral
Intervention description(s): The patient will have to walk on a treadmill in four different conditions:
without distraction at preferential speed
with distraction at preferential speed
without distraction at the speed of 130% of the preferential speed
with distraction at the speed of 130% of the preferential speed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effects of a Western-type Diet on Colorectal Inflammation
Condition: Colorectal Inflammation
MeSH terms: Inflammation
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study will look at the inflammatory (changes usually associated with infection/injury to
      the body) and bowel permeability (bowel's ability to allow contents to enter the body)
      effects of a Western-style diet (high fat and low in calcium) and a prudent-style diet (low
      fat and high in calcium) on the colon (large bowel). This study may provide information to
      prevent colorectal cancer in a high-risk population
    

Detailed description: 
      Hypothesis: Compared to a prudent-style diet, does a western-style diet increase colorectal
      inflammation thereby increasing gut permeability and causing increased endotoxins and markers
      of systemic inflammation.

      This is a single blind crossover study. Subjects will be randomized to begin on either a WD
      or a PD for 30 + 3 days. Once that dietary intervention is complete, subjects will have a
      four (4) week wash-out period and then will be placed on the other dietary intervention for
      30 + 3 days. The following study measures are performed during both the dietary intervention
      study periods. All the baseline tests will be repeated at the end of each dietary
      intervention period.
    

Intervention name(s): Western style diet (high fat and low in calcium); Prudent-style diet (low fat and high in calcium)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects will be randomized to begin on either a WD or a PD for 30 + 3 days. Once that dietary intervention is complete, subjects will have a four (4) week wash-out period and then will be placed on the other dietary intervention for 30 + 3 days; Subjects will be randomized to begin on either a WD or a PD for 30 + 3 days. Once that dietary intervention is complete, subjects will have a four (4) week wash-out period and then will be placed on the other dietary intervention for 30 + 3 days
Intervention MeSH terms: Calcium, Dietary; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Basic Science
A Phase 2 Study to Evaluate the Safety and Efficacy of YRA-1909 in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, randomized, double-blind phase2 study to evaluate the safety and
      investigate the efficacy of YRA-1909 in Patients with Rheumatoid Arthritis who are on a
      stable dose of Methotrexate(MTX) and who have an inadequate response to MTX(MTX-IR).
    


Intervention name(s): YRA-1909 low dose; YRA-1909 mid dose; YRA-1909 high dose; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A low dose of YRA-1909; daily oral intake for 12 weeks; A mid dose of YRA-1909; daily oral intake for 12 weeks; A high dose of YRA-1909; daily oral intake for 12 weeks; Matching placebo dosing with daily oral intake for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Screening of Hepatocellular Carcinoma in Patients With Compensated Cirrhosis
Condition: Compensated Cirrhosis
MeSH terms: Carcinoma; Carcinoma, Hepatocellular; Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Liver carcinoma is becoming the main complication of cirrhosis. Treatment of symptomatic or
      large tumors is disappointing. Regular ultrasonographic screening of small (curable) tumors
      is currently recommended, but the best periodicity is unknown.This randomized trial is aimed
      to compare 6-month (current recommendation) and 3-month ultrasonographic screenings.
    

Detailed description: 
      Patients: All consecutive patients with compensated HBV, HCV, alcohol or
      hemochromatosis-related cirrhosis (without any previous clinical complication including liver
      cancer).

      Randomization: factorial: ultrasonography (3-month versus 6-month); serum alfa-fetoprotein
      assay (none versus 6-month).

      End points: rate of small tumors (first main criteria); survival (second main criteria).
    

Intervention name(s): Ultrasonographic screening
Intervention type(s): Procedure
Intervention description(s): Ultrasonographic screening
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Keywords: Cirrhosis; Hepatocellular carcinoma; Screening; Randomized; HBV; HCV; alcohol; hemochromatosis
Efficacy Park Study Assessing Rhinix™ Nasal Filters for Hay Fever
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional

Summary: 
      This study will evaluate the effects of RHINIX™ nasal filters on seasonal allergic rhinitis
      (hay fever) in a park setting.
    

Detailed description: 
      The study will include 100 participants with grass allergy and will look at the efficacy and
      usability of RHINIX™ nasal filters on hay fever in a randomized, double-blind,
      placebo-controlled, crossover design.
    

Intervention name(s): Placebo Filter; Rhinix Nasal Filter
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Clinical Effects of a Nucleotides-Supplemented Infant Formula
Condition: Nutritional Requirements
Study type: Interventional

Summary: 
      The study hypothesis is that different concentrations of nucleotides' supplementation of an
      infant formula might affect differently growth and/or other clinical parameters in neonates.
    

Detailed description: 
      Three groups of 50 newborn infants each, will be fed for 30 days an infant formula
      supplemented with either 4.9 mg/100 kcal or 10.6 mg/100 kcal of nucleotides or with no
      supplementation. Newborns will be monitored prospectively for the following outcome
      parameters:

        -  Growth percentiles.

        -  Behaviour and infantile colic.

        -  Bowel habits.

        -  Side effects.
    

Intervention name(s): Nutritional supplementation (nucleotides)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Infant nutrition; Nucleotides; Infant formula
Drug-drug Interaction Trial of BI 113608 in Combination With Ketoconazole and Voriconazole in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the relative bioavailability of a
      single oral dose of BI 113608 without and with ketoconazole and voriconazole at steady state.
      The assessment of safety and tolerability of BI 113608 administered alone and upon
      co-administration will be an additional objective of this trial.
    


Intervention name(s): BI 113608; BI 113608; BI 113608; Ketoconazole; Voriconazole
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): tablet; tablet; tablet; tablet; tablet
Intervention MeSH terms: Ketoconazole; Voriconazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study Assessing the Effects of Darunavir/Ritonavir or Lopinavir/Ritonavir on the Pharmacokinetics of Daclatasvir in Healthy Participants
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether multiple doses of darunavir/ritonavir or
      lopinavir/ritonavir affect the pharmacokinetics of daclatasvir in healthy participants.
    


Intervention name(s): Daclatasvir; Darunavir; Ritonavir; Lopinavir/Ritonavir
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): BMS-790052; Prezista; Norvir
Intervention MeSH terms: Ritonavir; Lopinavir; Darunavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Manual Therapy and Exercise Versus Home Exercises in the Management of Patients Status Post Ankle Sprain
Condition: Ankle Sprain
MeSH terms: Sprains and Strains; Ankle Injuries
Study type: Interventional

Summary: 
      A recent study has demonstrated that a physical therapist directed exercise program did not
      result in greater reductions in disability and pain when compared to a home exercise program.
      However, no manual therapy procedures were incorporated into the physical therapy treatment
      program despite recent evidence suggesting that thrust and non-thrust manual therapy
      techniques may be beneficial in reducing disability, pain and improving gait. Therefore, the
      purpose of this study is to compare the effectiveness of a physical therapy management
      approach consisting of manual therapy and exercise to a home program of exercise only. The
      investigators hypothesize that the group receiving manual therapy and exercise will have
      better outcomes.
    


Intervention name(s): Manual Therapy and Exercise; Home exercises
Intervention type(s): Other; Other
Intervention description(s): Manual Therapy and Exercise; Home exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: ankle sprain; manual therapy; exercise; physical therapy; Patients who have sustained an inversion ankle sprain
Valuation of Quality of Life in Children With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      The aim of the study is valuation of quality of life (QL) in children with asthma and
      analysis of the factors that can have influence on it. The clinical problems included into
      the aim are to evaluate:

        -  the correlation between the QL and asthma control

        -  the utility of the Polish Version of PAQLQ(S) by Juniper, especially the understanding
           of each question and it's answers The results of this study can be very helpful in the
           future in developing a questionnaires to use in Polish Primary Care, according to which
           the investigators would be able to see whether the asthma in our patients is being well
           controlled.
    

Detailed description: 
      Quality of Life in people with asthma is strictly relevant with the correct treatment of the
      disease, that is why the correct screening of patient's quality of life, especially in
      children, is so important.

      Exploring the quality of life (QL), we use different types of questionnaires to obtain a
      quantitative result, which we can interpret using a compatible key for it. Pediatric Asthma
      Quality of Life Questionnaire with Standardized Activities (PAQLQ(S)) by Juniper is a
      reliable measure of the influence of asthma on QL in children. The Polish Version of the
      questionnaire is a strict translation of the english one, however it is not completely
      validated, which in practice can evince in difficulties in understanding the meaning of the
      applied questions, probably because of the difference in the habits of both populations.

      The aim of the study is valuation of quality of life (QL) in children with asthma and
      analysis of the factors that can have influence on it. The clinical problems included into
      the aim are to evaluate:

        -  the correlation between the QL and asthma control

        -  the utility of the Polish Version of PAQLQ(S) by Juniper, especially the understanding
           of each question and it's answers The results of this study can be very helpful in the
           future in developing a questionnaires to use in Polish Primary Care, according to which
           we would be able to see whether the asthma in our patients is being well controlled.
    

Intervention name(s): Polish Version of PAQLQ(S) by Juniper; spirometry
Intervention type(s): Other; Other
Intervention description(s): Polish Version of PAQLQ(S) by Juniper; spirometry
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with asthma.
      
Keywords: Asthma Control; Quality of Life; Children; Polish Version of PAQLQ(S) by Juniper
Safety and Efficacy of OMS103HP-S Administered in Joint Irrigation Solution to Subjects Undergoing Arthroscopic Meniscectomy
Condition: Meniscal Tear
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the effect of OMS103HP solution for Injection
      (OMS103HP-S) and function as measured by the Knee Osteoarthritis Outcome Survey (KOOS)
      Symptoms subscale through Day 30 compared with vehicle irrigation solution for knee symptoms
      in subjects undergoing meniscectomy.
    


Intervention name(s): OMS103HP-S; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Proprietary concentration and formulation of OMS103HP in solution (OMS103HP-S) for injection into each 3 liter vehicle irrigation solution bag for use during meniscectomy surgery; 3 Liter bags of vehicle irrigation solution for use during meniscectomy surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Meniscectomy; Knee Pain; Postoperative Pain
An Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy
Condition: Crohn's Disease; Ulcerative Colitis; Rectal Cancer; Colon Cancer; Colon Polyps; Rectal Polyps; Diverticulitis
MeSH terms: Crohn Disease; Diverticulitis; Polyps
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to find out if guided fluid administration with the esophageal
      monitor is superior to standard fluid administration and whether use of the hetastarch or
      lactated ringers offers different benefits with respect to length of stay in the hospital
      after hand-assisted colorectal surgery.
    


Intervention name(s): Hextend; Lactated Ringers
Intervention type(s): Drug; Drug
Intervention description(s): Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care versus Either Colloid and Crystalloid; Assessment of Goal-Directed Intraoperative Fluid Management in Hand Assisted Laparoscopic Colectomy: Standard Care versus Either Colloid and Crystalloid
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Hand-assisted colorectal surgery; colorectal disease; Crohn's; diverticulitis; Colorectal resections
Supplementation of Land-based Stearidonic Acid (SDA)-Rich Oils in Humans
Condition: Hypercholesterolemia; Overweight
MeSH terms: Overweight; Hypercholesterolemia
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The objective of this study is to investigate the conversion of the precursors ALA and SDA
      into n-3 LC-PUFA (EPA, DPA and DHA) in humans by oral supplementation of Echium oil in
      comparison with SDA soybean oil (positive control). In addition, the accumulation of n-3
      LC-PUFA is compared between subpopulations of different age, gender and physiological
      conditions (overweight, increased serum total cholesterol).
    

Detailed description: 
      N-3 PUFA are important for human health and nutrition. Due to the increasing world
      population, overfishing of the seas and generally low amounts of n-3 PUFA in major oil crops,
      there is a demand for new sources of n-3 PUFA.

      One approach involves searching for potential vegetable sources of n-3 PUFA; especially those
      rich in ALA and SDA. The conversion of ALA to SDA in humans depends on the rate-limiting
      ∆6-desaturation. Plant-derived SDA is therefore a promising precursor regarding endogenous
      synthesis of n-3 LC-PUFA in humans. The enrichment of n-3 LC-PUFA in human lipids during the
      supplementation of ALA- and SDA-rich Echium oil will be compared with SDA-rich soybean oil.

      Eighty volunteers will be recruited and allocated into four study groups depending on age and
      BMI. Three groups (each n=20) will receive daily ca. 20 g Echium oil ( group 1 and 2: mean
      BMI < 25, with mean age: 25 or 55 years; group 3: mean age 55 and BMI > 25). One group (n=20)
      will receive SDA soybean oil ( dose with comparable amount of SDA; BMI < 25; mean age 25 and
      55). The double-blind, randomized, parallel-designed study will start with a two-weeks run-in
      period, followed by an eight-weeks supplementation period. After the run-in period, one week
      and eight weeks of oil supplementation blood will be drawn and 24-h urine will be sampled.
    

Intervention name(s): Echium oil
Intervention type(s): Dietary Supplement
Intervention description(s): Oil of Echium platagineum (natural plant oil) ca. 15-18 g/d (Croda)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Conversion of ALA and SDA; Metabolism of n-3 fatty acids
Effect of Lixisenatide on Postprandial Plasma Glucose Compared to Sitagliptin in Combination With Insulin Glargine
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To demonstrate significant reduction in postprandial plasma glucose (ΔAUC0:30-4:30h) after a
      standardized breakfast from baseline to Day 29.

      Secondary Objectives:

      To demonstrate:

        -  Changes from baseline to Day 29 in maximum postprandial plasma glucose excursion,
           C-peptide and glucagon levels after a standardized breakfast

        -  Delaying gastric emptying (13C-acetic acid breath test)

        -  Safety and tolerability
    

Detailed description: 
      The duration per patient could be minimum of 38 to 47 days depending on screening visit and
      post-treatment observation allowances.

      13C-acetic acid breath test will be conducted only in investigational site which can be
      implemented (about 40 patients).
    

Intervention name(s): LIXISENATIDE AVE0010; Sitagliptin; Insulin glargine HOE901
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form:solution Route of administration: subcutaneous; Pharmaceutical form:tablet Route of administration: oral; Pharmaceutical form:solution Route of administration: subcutaneous
Other intervention name(s): Januvia; Lantus
Intervention MeSH terms: Insulin Glargine; Sitagliptin Phosphate; Lixisenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Determine and Compare Plasma and Intrapulmonary Pharmacokinetics of WCK 2349 in Healthy Adult Human Subjects
Condition: Intrapulmonary Pharmacokinetics of WCK 2349
Study type: Interventional
Phase: Phase 1

Summary: 
      This study to determine and compare plasma, epithelial lining fluid (ELF) and alveolar
      macrophage (AM) concentrations of levonadifloxacin after administration of WCK 2349 in
      healthy adult subjects.
    


Intervention name(s): WCK-2349
Intervention type(s): Drug
Intervention description(s): Each subject will receive ten oral doses of 1000 mg WCK 2349 administered twice-daily starting on Day 1
Intervention MeSH terms: Levonadifloxacin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science