bioihbjkbjnl/mcl2 huggingface dataset:
Bioequivalence Study of Two Octreotide Microsphere Formulations in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this clinical trial is to evaluate the pharmacokinetic characteristics of two
      octreotide microsphere formulations in healthy Chinese volunteers.

      Participants will receive single-dose of either test or reference octreotide microsphere
      formulations.

      Researchers will compare pharmacokinetic characteristics of the two formulations to see if
      they are bioequivalent.
    


Intervention name(s): The test octreotide microsphere; The reference octreotide microsphere
Intervention type(s): Drug; Drug
Intervention description(s): A single intramuscular dose of the test octreotide microsphere 30mg,; A single intramuscular dose of the reference octreotide microsphere 30mg
Intervention MeSH terms: Octreotide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of Voriconazole Penetration Into the Brain by Fluorine-Magnetic Resonance Spectroscopy
Condition: Fungal Infection
MeSH terms: Mycoses
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the amount of voriconazole in the brain by
      fluorine-magnetic resonance spectroscopy (MRS) and to compare brain levels to plasma levels.
    


Intervention name(s): Voriconazole
Intervention type(s): Drug
Intervention MeSH terms: Voriconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Project FLUx COntact-CoVID-19 Faculty of Medicine Paris-Saclay
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The worldwide health system has been marked by the SARS-CoV-2 pandemic. French educational
      system has been upset, especially medical schools, which, because of their hospital location,
      are particularly exposed to the spread of the virus. The medical school of Paris-Saclay
      University, located within bicetre University Hospital, AP-HP, must therefore adapt on a
      daily basis to ensure educational continuity. Taking advantage of an exceptional scientific
      ecosystem, innovative viral epidemic propagation modeling approaches based on both simulation
      and contact tracing data will be tested in real-life conditions. These propagation models
      will serve to scientifically optimize future educational organization procedures in this
      medical school.
    

Detailed description: 
      All the participants will be equipped with individual wireless contact tracing technology.
      Anonymised contact events will be automatically monitored for a period of two months to
      measure the daily contact flow density between the students at medical school. Epidemic
      simulation models will be enriched with these real contact tracing data to generate optimized
      viral propagation probability networks. During the same period, CO2 measurement will be
      performed in several relevant sectors (classrooms, amphitheaters, corridors etc) to allow a
      more holistic understanding of the propagation conditions. Finally, the probabilistic models
      will be confronted to the results of a two step COVID-19 screening campaign.
    

Intervention name(s): Antigenic tests (on saliva samples); Individual electronic sensor port; Atmospheric measurements of CO2
Intervention type(s): Other; Other; Other
Intervention description(s): SARS-CoV-2 screening tests: two massive antigenic tests campaigns (on salivary samples).; Individual electronic sensor recording contacts but not their location (in the form of a bracelet, a key ring or a badge) Contact data collection points (5 maximum, located at compulsory passage points for participants). When a sensor is close to one of these terminals, it discharges its contacts in seconds.; Atmospheric measurements of CO2 in the relevant closed places of the faculty (lectures / practical work / BU / refectory): battery operated sensors. When a sensor is installed in a place, the ventilation conditions (number of open windows, etc.) as well as the number of people present will be noted.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Simulation; epidemiology; public health; computer science; infectiology; technology; pandemic COVID
The Relationship Between Microsatellite Instability and Efficacy of Fluorouracil Based Adjuvant Chemotherapy in Gastric Cancer After Operation
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms; Microsatellite Instability
Study type: Observational

Summary: 
      The relationship between Microsatellite instability and efficacy of fluorouracil based
      adjuvant chemotherapy in gastric cancer after operation.
    

Detailed description: 
      To explore the relationship between Microsatellite instability and efficacy of fluorouracil
      based adjuvant chemotherapy in gastric cancer after operation.
    

Intervention name(s): Microsatellite instability
Intervention type(s): Other
Intervention description(s): The microsatellite instability status are definite to three type:MSI-H, MSI-L,and MSS. The gastric cancer patients who received D2 resection were included in 3 groups：MSI-H group， MSI-L group，and MSS group. All patient must be accept fluorouracil(5-FU) based adjuvant chemotherapy. We will analyze the relationship between MSI status and efficacy of 5-FU based adjuvant chemotherapy by observing the survival period of patients with different MSI status.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        gastric cancer
      
Keywords: Microsatellite Instability; Fluorouracil; Adjuvant chemotherapy; Efficacy; Operation
I125 Brachytherapy After TURP
Condition: Cancer
Study type: Observational

Summary: 
      Low dose rate brachytherapy using iodine 125 is well established as a treatment for low and
      intermediate risk prostate cancer. Currently there is uncertainty as to the safety of this
      technique in patients who have had a previous transurethral resection of the prostate gland
      (TURP) for obstruction of the urine flow through the prostatic urethra. Early experience when
      the technique was being developed in the 1980s suggested that there was a higher incidence of
      urinary incontinence after brachytherapy if there had been a previous TURP. It is however
      clear that with increasing experience many centres offer this treatment to patients who have
      had previous TURP, using various parameters to select patients including time from the TURP
      and persence or absence of a significant cavity within the gland on MRI scanning. There has
      been no systematic study of I125 brachytherapy after TURP in the current era which might
      address and inform the practice for future patient. Hence this study is designed to formally
      assess the safety of I125 brachytherapy after previous TURP.
    


Intervention name(s): I125 brachytherapy
Intervention type(s): Radiation
Intervention description(s): I125 brachytherapy is a standard treatment and will be delivered using routine techniques involving a preimplant volume study followed by implantation of the I125 sources. This is undertaken as an inpatient or day case under general or spinal anaesthetic according to local practice
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients taking part will do so having chosen I125 brachytherapy as their chosen treatment
        for prostate cancer and will have previously undergone TURP
Mushroom Effects on Satiety and Gut Health Markers
Condition: Diet Modification
Study type: Interventional

Summary: 
      The Investigator will compare the effect of mushrooms to ground beef in an intervention study
      and measure satiety markers and gut health markers
    

Detailed description: 
      Subjects will consume their habitual diet and the investigators will compare the acute effect
      of mushroom consumption on satiety and food intake. Additionally, subjects will consume
      mushrooms for 10 days and the investigators will measure gut health markers, including short
      chain fatty acids, microbiota, and fecal weight.
    

Intervention name(s): mushroom; ground beef
Intervention type(s): Dietary Supplement; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study on The Effect of Multiple Dose Carbamazepine on Single Dose Pharmacokinetics of RO4917838 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, fixed sequence, two-period study will assess the effect of multiple dose
      carbamazepine on the single dose pharmacokinetics of RO4917838. Subjects will receive a
      single oral dose of RO4917838 on Day 1 of the 12-day study period 1 and, after a washout of
      3-6 weeks, in study period 2 carbamazepine orally daily on Days 1-24 with a single oral dose
      of RO4917838 on Day 16.
    


Intervention name(s): RO4917838; carbamazepine
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose, Day 1 of study period 1 and Day 16 of study period 2; multiple oral doses, Days 1-24 of study period 2
Intervention MeSH terms: Carbamazepine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
A Trial Investigating the Absolute Bioavailability of Insulin Degludec in Healthy Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of the trial is to investigate the absolute
      bioavailability of insulin degludec (IDeg) in healthy subjects.
    


Intervention name(s): insulin degludec; insulin degludec
Intervention type(s): Drug; Drug
Intervention description(s): A single dose of 0.4 U/kg body weight will be administered subcutaneously (s.c., under the skin).; A single dose of 0.04 U/kg body weight will be administered intravenously (i.v., into the vein).
Other intervention name(s): IDeg
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin, Long-Acting
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Investigation of a New Human Model for Itch
Condition: Itch
Study type: Interventional

Summary: 
      This third sub-project aims to evaluate the interaction between the TRPM8 receptor and
      pruritus by studying the anti-pruritic effect of TPRM8-agonist L-menthol on histaminergic and
      non-histaminergic itch induced using three different pruritogens: histamine, cowhage and
      papain.
    


Intervention name(s): Papain; Histamine; Cowhage; L-menthol
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Papain will be applied using cowhage spicules inactivated by heat; To deliver histamine, standard allergy skin prick test (SPT) lancets are applied; Cowhage spicules are 1-2 mm in length and have a diameter of 1-3 μm. The spicules are inserted by gently rubbing 30-35 spicules into a 1 cm diameter skin area.; A 1 mL aliquot is dispensed onto a 2,5 × 2,5 cm cotton pad and placed on a 6 × 6 cm sheet of medical tape.
Intervention MeSH terms: Menthol; Histamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Randomized, Open-label, Single Dose, Two-way Crossover Clinical Trial to Compare the Safety, Pharmacokinetic Profiles of UI15AML055MT and Amosartan® Tablet 5/50 mg After a Single Oral Administration in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, single dose, two-way crossover clinical trial to compare the
      safety, pharmacokinetic profiles of UI15AML055MT and Amosartan® tablet 5/50 mg after a single
      oral administration in healthy male volunteers
    

Detailed description: 
      A randomized, open-label, single dose, two-way crossover clinical trial to compare the
      safety, pharmacokinetic profiles of UI15AML055MT and Amosartan® tablet 5/50 mg after a single
      oral administration in healthy male volunteers
    

Intervention name(s): UI15AML055MT; Amosartan 5/50
Intervention type(s): Drug; Drug
Intervention description(s): tab, PO; tab, PO
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amlodipine basylate, Losartan potassium
Plasma Level of Various Omega-3 Lipids
Condition: Healthy
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate the pharmacokinetic properties of 3 OM3
      oils after a single-dose administration in healthy volunteers
    

Detailed description: 
      This is a single center, open design, randomized, controlled, cross-over trial with 3 test
      periods and 3 products (one test period per product). The three different test periods will
      be separated by a washout period of at least 6 days (up to 21 days).
    

Intervention name(s): OM3-FFA; OM3-MAG; OM3-EE
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Comparison of the effects of OM3-FFA versus OM3-MAG and OM3-EE in a crossover design; Comparison of the effects of OM3-MAG versus OM3-FFA and OM3-EE in a crossover design; Comparison of the effects of OM3-EE versus OM3-FFA and OM3-MAG in a crossover design
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single center, open design, randomized, controlled, cross-over trial with 3 test periods and 3 food supplements containing omega3 (one test period per product).
Masking: None (Open Label)
Primary purpose: Other
Phase I BP Interferon (IFN) Beta-004
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I study aiming at:

        -  establishing the pharmacokinetic profile of interferon beta-1a after i.v. administration
           of the formulation BioPartners IFN beta-1a without albumin (HSA-free solution in
           pre-filled syringes) at 18 MIU;

        -  investigating the possible impact of albumin on pharmacokinetic profile by comparing 3
           different i.v. formulations: BioPartners IFN beta-1a without albumin (HSA-free solution
           in pre-filled syringes), BioPartners IFN beta-1a with added albumin (HSA+), and Rebif®
           from Merck-Serono, a registered IFN beta-1a solution containing HSA;

        -  establishing the steady state pharmacokinetic profile of BioPartners IFN beta-1a in
           HSA-free solution after 4 subsequent s.c. doses of 18 MIU given at 48 hour intervals
           against Rebif® using the same regimen.
    


Intervention name(s): Interferon beta-1a HSA-free biosimilar; Interferon beta-1a HSA+ biosimilar; Interferon beta-1a original
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 6 MIU/0.53 mL in pre-filled glass syringe solubilized in aqueous isotonic buffered solution without albumin; 6 MIU/0.53 mL in pre-filled glass syringe solubilized in aqueous isotonic buffered solution combined with albumin solution; 6 MIU/0.50 mL in pre-filled glass syringe solubilized in HSA and mannitol solution (marketed formulation)
Other intervention name(s): Bioferon®; Bioferon®; Rebif®
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Carbohydrate and Metabolism: a Pilot Study
Condition: Infant; Metabolism
Study type: Interventional

Summary: 
      The optimal choice of carbohydrate in infant formula needs to be assessed in more detail.
      Lactose has conventionally been used in most milk-based infant formulas, but more recently
      lactose-free formulas based on corn syrup solids/maltodextrins have gained in popularity.
      However, the metabolic consequences have not been examined.

      In a pilot study, the investigators will assess the postprandial metabolic response to a meal
      of formula with either lactose or maltodextrins. A breastfed reference group is also
      included.
    


Intervention name(s): Formula with lactose; Formula with maltodextrins
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
A Phase 1 Study To Evaluate The Pharmacokinetics And Safety Of Three Modified Release And One Immediate Release Formulations Of Tofacitinib (CP-690,550) In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will explore the drug behavior and safety following a single dose of three
      different 22 milligram tofacitinib (CP-690,550) modified-release formulations in 30 healthy
      volunteers. These formulations will be compared to 10 milligram tofacitinib (CP-690-550) in
      an immediate-release formulation.
    


Intervention name(s): tofacitinib (CP-690,550) modified-release formulation A; tofacitinib (CP-690,550) modified-release formulation B1; tofacitinib (CP-690,550) modified-release formulation A; tofacitinib (CP-690,550) modified-release formulation B1; tofacitinib (CP-690,550) modified-release formulation B2; tofacitinib (CP-690,550) immediate-release formulation
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered with food.; A single dose of 22 mg tofacitinib (CP-690,550) MR-B1 formulation administered with food; A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered without food; A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B1 administered without food; A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B2 administered without food; A single dose of 10 mg tofacitinib (CP-690,550) immediate-release formulation administered without food
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: tofacitinib; CP-690; 550; relative bioavailability; modified release; Phase 1
Effects of Whey Protein and Collagen Supplementation
Condition: Exercise; Nutrition Therapy; Resistance Training; Muscle Strength; Hypertrophy
MeSH terms: Hypertrophy
Study type: Interventional

Summary: 
      The present project aims to investigate the effects of high-quality protein (whey protein)
      vs. low-quality protein (collagen) on muscle mass and function (e.g., strength and power)
      during a 10-wk resistance training program in young adults. It will be tested the hypothesis
      that leucine-matched collagen should promote similar gains on muscle function and mass
      compared to whey protein supplementation.
    

Detailed description: 
      The purpose of this study will be to investigate the effects of whey protein vs.
      leucine-matched collagen supplementation on muscle mass and function after a 10-wk resistance
      training program. Initially, all participants will be submitted for a 2-wk familiarization
      period, and then randomized into two groups (N = 11 / group): whey protein group and
      leucine-matched collagen group. The following variables will be assessed from pre-to
      post-training: anthropometric, muscle thickness from vastus lateralis and biceps brachii
      muscles using ultrasound, training load, mean power and peak torque for unilateral arm
      flexion exercise using a isokinetic dynamometer, countermovement vertical jump, nutritional
      intake, and testosterone-to-cortisol ratio . Shapiro-Wilk and Levine tests will be used to
      test the normality and homogeneity of the measurements, respectively. Two-way ANOVA (group x
      time) tests for repeated measures will be performed to assess changes over time and between
      groups for all dependent variables. Violation of sphericity will adjust using Greenhouse-
      Geyser correction. The Bonferroni post-hoc test will detect specific differences between
      groups. When appropriate, the percentage of change (∆%) will be reported according to the
      following equation: ∆% = [(pre-average post average) / pre-average mean] × 100. Values will
      be express as mean ± standard deviation. O significance level α will be 0.05.
    

Intervention name(s): Whey protein supplementation; Collagen supplementation
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 35 g of whey protein (7 d/wk) during a 10-wk resistance training program (3 d/wk; 3 sets of 8-12 repetitions with an interval of 1-2 minutes between sets and exercises) involving the leg press, leg extension, and arm flexion exercises. The load will be adjusted weekly.; 35 g of collagen (7 d/wk) + 2 g of leucine during a 10-wk resistance training program (3 d/wk; 3 sets of 8-12 repetitions with an interval of 1-2 minutes between sets and exercises) involving the leg press, leg extension, and arm flexion exercises. The load will be adjusted weekly.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Protein supplementation; Amino acids; Resistance exercise; Muscle strength; Muscle hypertrophy
The Effects of Cervical Mobilization on Cognitive Performance
Condition: Pain, Chronic
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      Non spesific cervical pain syndromes are the most common cervical pathologies encountered in
      clinical practice. Non spesific cervical pain syndrome occurs as a result of postural
      deformities.

      Massage and mobilization techniques are used in the treatment of Non spesific cervical pain
      syndrome due to their analgesic effects. The Cyriax mobilization technique is a manual
      therapy method applies to correct the limitation of movement in the joint and to relieve pain
      and functional disorders. Many studies have shown that Cyriax mobilization technique provides
      faster and momentary painless joint movement compared to other physical therapy modalities.
      Cervical mobilisation techniques also have regulator effect on autonomic nerve system.
      Cervical mobilisation also has positive effects on anxiety and tension.
    

Detailed description: 
      In this study, 32 patients with age range 18-65 who applied to Kırşehir Ahi Evran University
      Training and Research Hospital were examined. The individuals included in the study were
      divided into two groups according to the paired randomization method. These groups were
      control and intervention groups. Traditional physiotherapy methods were applied to the
      control group, traditional physiotherapy and Cyriax mobilisation techniques were applied to
      the intervention group. Traditional physiotherapy methods were included; Transcutaneous
      Electrical Nerve Stimulation (TENS), Ultrasound (US), isometric strengthening exercises.

      For the evaluation of patients; Visual Analogue Scale (VAS), cervical goniometric
      measurements, Lowett muscle test, Burdon Test and Beck Anxiety Test were used.
    

Intervention name(s): Cyriax mobilization + traditional physiotherapy
Intervention type(s): Other
Intervention description(s): TENS, US, exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain Mobilisation; Anxiety