bioihbjkbjnl/mcl2 huggingface dataset:
nSTRIDE APS in Females With Primary Patellofemoral Osteoarthritis
Condition: Patellofemoral Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate clinical outcomes following a single injection of
      nSTRIDE Autologous Protein Solution in females with isolated patellofemoral osteoarthritis. A
      secondary objective of this study is to document the duration of treatment effect following
      nSTRIDE injection.
    

Detailed description: 
      Clinical trials have, in general, formally demonstrated the effectiveness and safety of
      various autologous therapies for the treatment of knee OA. Differences in the processing of
      autologous therapies can yield substantial differences in the resulting output. Thus, making
      generalizations regarding the effectiveness across these autologous therapies is more
      complicated. Each autologous therapy requires independent efficacy evaluation. nSTRIDE APS
      has been shown to decrease pain, increase function and have a favorable safety profile in a
      pilot trial. Further, demonstration of the treatment effects in patellofemoral
      osteoarthritis, an important subset of knee osteoarthritis is lacking. This study will
      evaluate a population of female patients with patellofemoral osteoarthritis in which
      treatment with other modalities provides limited/short lived relief with the hope that APS
      treatment will provide and extend relief to these patients. The study will document the
      treatment effects and timeline of treatment effects for nSTRIDE APS following a single
      injection (per symptomatic knee).
    

Intervention name(s): nSTRIDE Autologous Protein Solution (APS) Kit
Intervention type(s): Device
Intervention description(s): Intra-articular injection of APS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autologous Protein Solution; Patellofemoral Osteoarthritis; Female
Evaluation of the Irritation Potential of Products in Human Eyes
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To evaluate the human eye irritation potential of one test sunscreen formulation.
    


Intervention name(s): Sunscreen lotion SPF (Sun Protection Factor) 50 (BAY987521); Ophthalmic Ointment
Intervention type(s): Other; Other
Intervention description(s): Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.; Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.
Intervention MeSH terms: Sunscreening Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Metformin
Condition: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Metformin; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of multiple doses of isavuconazole on the
      pharmacokinetics of a single dose of metformin. Safety and tolerability of isavuconazole will
      be assessed alone and in combination with metformin.
    

Detailed description: 
      Subjects will check-in to the clinic on Day -1 and remain confined through completion of the
      study procedures on Day 10.

      A follow-up telephone call will be made on Day 16 to check on health status.
    

Intervention name(s): isavuconazole; metformin
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): BAL8557; BAL4815; Glucophage®
Intervention MeSH terms: Metformin; Isavuconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Isavuconazole; Pharmacokinetics; Healthy Subjects; BAL8557; BAL4815; metformin
Peginterferon Alfa-2a, Ribavirin and Epoetin β in Coinfected Patients HCV/HIV Not Responding to Previous Treatment Regimens
Condition: Hepatitis C; HIV Infections
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial will assess the sustained virologic response to treatment with peginterferon
      alfa-2a combined with high-dose ribavirin in human immunodeficiency virus (HIV)-infected
      patients with hepatitis C virus (HCV) genotype 1 or 4 coinfection and persistent transaminase
      elevations. These patients will have been nonresponders to previous regimens with
      peginterferon alfa and ribavirin therapy at a dosage of 800-1200 mg/d.
    

Detailed description: 
      The purpose in treating chronic HCV infection in HIV-coinfected individuals is to clear
      HCV-RNA antibodies and cure the infection. Studies have shown that high doses of ribavirin
      are associated with higher response rates than those achieved with ribavirin at dosages of
      800-1200 mg/d.

      The main aim of this trial is to assess the sustained virologic response to treatment with
      peginterferon alfa-2a plus high-dose ribavirin in HIV-infected patients coinfected with HCV
      genotypes 1 or 4 who have had persistent transaminase elevations and lack of response to
      previous treatment with peginterferon alfa and ribavirin at dosages of 800-1200 mg/d.

      The second aim will be to measure changes in serum HCV-RNA titers and the percentage of
      patients achieving serum viral loads of < 50 IU/mL during treatment. Finally, we also intend
      to evaluate the safety of this treatment regimen.
    

Intervention name(s): Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week; Ribavirin (Copegus®) 1600 mg/day; Epoetin β (450 UI/kg/week)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Peginterferón alfa-2a (40 KD) (Pegasys®) 180 ug/week; Ribavirin (Copegus®) 1600 mg/day; Epoetin β (450 UI/kg/week)
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ribavirin; non-responders; HCV co-infected patients; sustained virological response; Treatment Experienced
Ondansetron for Postspinal Anesthesia Hypotension
Condition: Adverse Effect
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effectiveness of ondansetron for postspinal
      anesthesia hypotension in patients undergoing cesarean section.
    

Detailed description: 
      Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for
      cesarean section. The incidence of post-spinal anesthesia hypotension is as high as
      62.1-89.7% if prophylactic measures are not taken. Ondansetron have been highly demonstrated
      for prevention and/or treatment of post-spinal anesthesia hypotension. However, whether
      ondansetron could further reduction the incidence of post-spinal anesthesia hypotension is
      still unknown. The purpose of this study is to investigate the effectiveness of ondansetron
      for postspinal anesthesia hypotension in patients undergoing cesarean section.
    

Intervention name(s): normal saline; Ondansetron 4 mg; Ondansetron 8 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A bolus of normal saline (2 ml) by IV was given 5 min before spinal anesthesia.; A bolus of ondansetron (2 ml; 4mg) by IV was given 5 min before spinal anesthesia.; A bolus of ondansetron (2 ml; 8mg) by IV was given 5 min before spinal anesthesia.
Other intervention name(s): NS; 5-HT3 receptor antagonist; 5-HT3 receptor antagonist
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Ondansetron; Coload; Hypotension; Cesarean section
Study of the Effects of Carbohydrate Counting
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The investigators hypothesize that non-optimally treated carbohydrate counting-naïve patients
      with type 1 diabetes can achieve better metabolic control by counting carbohydrates and that
      the metabolic control can be further improved with concurrent use of an integrated glucose
      meter and bolus calculator. The investigators want to test the hypothesis in this study.
    


Intervention name(s): Education; Education
Intervention type(s): Other; Other
Intervention description(s): Participants are taught the principles of carb counting; Participants are taught the principles of carb counting and the use of the integrated glucose meter and bolus calculator.
Other intervention name(s): The integrated glucose meter and bolus calculator: Aviva Expert, Roche
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Carbohydrate counting; Insulin bolus calculation
Clinical Study Investigating the Efficacy of a Mouthwash in Providing Long Term Relief From Dentinal Hypersensitivity
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to investigate the longitudinal efficacy of a potassium nitrate
      mouthwash formulation when used as an adjunct to brushing with a standard fluoride dentifrice
      for the relief of dentinal hypersensitivity (DH) compared to brushing with a standard
      fluoride dentifrice alone. This will be a single centre, eight week, randomised, examiner
      blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff Sensitivity
      Score of the two selected test teeth) study in participants with at least two sensitive teeth
      that meet all the criteria at the Screening and Baseline visit. Participants will be assessed
      at Baseline, and at four and eight weeks to monitor clinical efficacy and safety.
    


Intervention name(s): Potassium nitrate and sodium fluoride; Standard fluoride dentifrice
Intervention type(s): Drug; Drug
Intervention description(s): 3.0% w/w potassium nitrate mouthwash with 0.02% sodium fluoride; Standard fluoride dentifrice containing 1000 ppm fluoride as SMFP
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Safety and Tolerability of PG110 in Patients With Knee Osteoarthritis Pain
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of a single intravenous
      dose of PG110, a monoclonal antibody that inhibits the effects of the naturally occurring
      substance, nerve growth factor (NGF).
    


Intervention name(s): PG110; PG110; PG110; PG110; PG110; PG110; PG110; PG110; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Single, slow intravenous infusion; Single, slow intravenous infusion; Single, slow intravenous infusion; Single, slow intravenous infusion; Single, slow intravenous infusion; Single, slow intravenous infusion; Single, slow intravenous infusion; Single, slow intravenous infusion; Single, slow intravenous infusion that matches PG110 in appearance
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of the Level of Dietary Protein on the Infant Hormonal Profile and Body Composition
Condition: Healthy
Study type: Interventional

Summary: 
      A double blind, controlled, randomized, single site clinical trial of 2 parallel groups (Low
      protein formula =LoF and High protein formula =HiF) with a breastfeeding group (BF) as
      reference from birth to 1 year of age and a follow up period from 1 year to 5 years of age.
    

Detailed description: 
      The primary objective of this clinical trial is to show that infants taking (from birth)
      either a formula with a low protein content (LoF) or breast milk will have an IGF-1 level, at
      4 months, 25% lower to the IGF-1 measured in infants that received a high protein content
      formula (HiF).

      The secondary objectives are: The hormonal profile; the Fat mass (FM) gain and the Lean mass
      (LM); the metabolomics and aminogramm during the first year of life.

      Subjects are included in the study for a duration of 5 years. From birth to 4 months they are
      exclusively fed BF or FF. From 4 months of age they can start diversification, but they
      maintain the starter formulas until 12 months (the BF group will receive LoF). Subjects are
      then followed up until 5 years of age.
    

Intervention name(s): Low protein formula; High protein formula
Intervention type(s): Other; Other
Other intervention name(s): LoF; HiF
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
A Study of Nasal PYY3-36 and Placebo for Weight Loss in Obese Subjects
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effect of nasal PYY3-36 on weight loss post 24
      weeks of treatment.
    

Detailed description: 
      This is a multi-center, Phase 2 double-blind, randomized, placebo-controlled trial in healthy
      obese patients. The primary objective of the study is to evaluate the effect of increasing
      nasal PYY3-36 dosing on weight loss post 24 weeks of treatment.

      Secondary Objectives:

        -  To evaluate the safety of three nasal PYY3 36 dose groups compared to nasal placebo

        -  To compare the weight loss post 12 and 24 weeks of treatment for each of the three nasal
           PYY3 36 dose groups versus the nasal placebo group

        -  To compare the proportion of patients who lose at least 5% and 10% of the baseline body
           weight post 12 and 24 weeks of therapy for each of the three nasal PYY3 36 dose groups
           versus the nasal placebo group

        -  To compare the weight loss and proportion of patients who lose at least 5% of the
           baseline body weight post 12 and 24 weeks of treatment with sibutramine versus capsule
           placebo

        -  To compare the weight loss and proportion of patients who lose at least 5% of the
           baseline body weight post 12 and 24 weeks of treatment with nasal placebo versus capsule
           placebo

        -  To compare the weight loss and proportion of patients who lose at least 5% of the
           baseline body weight post 12 and 24 weeks of treatment with sibutramine versus the nasal
           PYY3 36 dose groups

        -  To evaluate the effect of 12 and 24 weeks of treatment with nasal PYY3 36 and
           sibutramine on fasting lipid profile, plasma glucose, insulin, blood pressure and pulse,
           waist circumference and BMI

        -  To evaluate the effect of 24 weeks of treatment with nasal PYY3 36 and sibutramine on
           HbA1c levels
    

Intervention name(s): Nasal Placebo; Placebo Capsule; PYY3-36; PYY3-36; PYY3-36; Sibutramine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Nasal placebo, three times a day, 30 minutes before a meal for 24 weeks.; Placebo capsules will be taken once daily with or without food.; Nasal PYY3-36, three times a day, 30 minutes before a meal for 24 weeks.; Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks.; Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks.; Sibutramine will be taken once daily with or without food
Other intervention name(s): Meridia
Intervention MeSH terms: Sibutramine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: weight loss; dieting
Study of the SARS-COV-2 (COVID-19) Serological Profile of an Army Training Hospital Staff
Condition: Sars-CoV2
Study type: Observational

Summary: 
      Emerging in China in December 2019, Covid-19, whose pathogen is SARS-Cov-2, was declared a
      global pandemic in March 2020. The clinical presentation is highly variable, ranging from
      asymptomatic forms to acute respiratory distress and even death. Transmission occurs through
      droplets, with a R0 of approximately 3.

      Rapidly, population protection measures were put in place by governments, including the
      confinement of all persons whose functions were not considered essential and the closure of
      educational institutions.

      Health care institutions are places at risk of Covid-19 transmission and hospital staff are
      particularly exposed, either through direct contact with patients, contact with exposed
      persons or through the environment. In order to protect personnel, hygiene measures were
      immediately recalled and reinforced.

      This study is aimed at evaluating the incidence rate of anti-SARS-Cov2 seroconversion over 2
      months among hospital staff, without any supposed anti-Covid treatment 19.
    


Intervention name(s): Anti-SARS-CoV2 Serology; Questionnaire
Intervention type(s): Diagnostic Test; Other
Intervention description(s): A blood sample is collected by venipuncture at Day 0, Day 30 and Day 60. The anti-SARS-CoV2 serological status is measured by automated microplate ELISA technique on the EVOLIS analyzer (Biorad®), using reagent kits from EUROIMMUN France.; Data concerning personal exposure factors are collected in a questionnaire:
Socio-demographic factors: sex, age
Professional factors: Employment (type, pace, reception, service, care practices), wearing of personal protective equipment (type of equipment, frequency of use) and type of hospital
Non-professional factors: Contact with infected individuals, carrying of professional equipment and compliance with barrier measures
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population is composed of army training hospital staff who have not already been
        confirmed Covid-19 positive and who are not taking any treatment relative with Covid-19.
A Phase I Study Comparing Pharmacokinetics and Safety of Bevacizumab
Condition: Pharmacokinetics; Safety Issues
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the Clinical study is to evaluate the pharmacokinetic and safety profile of a new
      formulation of Bevacizumab (Zutrab®, Argentinian origin) when compared to two already
      marketed formulations of Bevacizumab Avastin® (reference product) and Cizumab® (Indian
      origin), to establish similarity.
    

Detailed description: 
      Three-way bridge phase 1 trial. It is conducted in healthy, male adult subjects, it is
      single-dose, double-blind, parallel groups, randomized and balanced.

      Blood samples are collected for up to 90 days, to determine serum drug concentration and
      anti-drug antibodies. Safety and tolerability are also assessed.
    

Intervention name(s): Bevacizumab
Intervention type(s): Biological
Intervention description(s): Single-dose infusion
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Bevacizumab; Biosimilar; Antineoplastic Agents; Bioequivalence; Immunogenicity; safety; healthy male volunteers
Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-9545 Following a Single Oral Dose (Part 1) and to Evaluate the Absolute and Relative Bioavailability of Oral Capsule Formulations of GDC-9545 (Part 2) in Healthy Female Subjects of Non-Childbearing Potential
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-center, two part study in healthy female subjects of
      non-childbearing potential to investigate the absorption, metabolism, and excretion of
      [14C]-GDC-9545 (Part 1), the absolute bioavailability of formulations F12 and F18 (i.e.,
      GDC-9545/F12 capsule, 30 mg and GDC-9545/F18 capsule, 30 mg) and relative bioavailability of
      GDC-9545 oral capsule F18 to the F12 formulation (Part 2). It is planned that Part 1 will
      begin prior to Part 2 of the study, and that the two parts of the study will partially
      overlap.
    


Intervention name(s): [14C]-GDC-9545; GDC-9545 Solution for Infusion; GDC-9545/F12 Capsule; GDC-9545/F18 Capsule
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants will receive a single oral dose of [14C]-GDC-9545 capsule, 30 milligrams (mg) (not more than [NMT] 4.6 megabecquerel [MBq]; 124 microcurie [μCi]) with approximately 240 millilitres (mL) water in the fasted state.; Treatment B: 30 mg GDC-9545 as a solution for infusion, 3 mg/mL administered intravenously (IV) in 10 mL as an infusion over 30 minutes.; Treatment C: GDC-9545/F12 capsule, 30 mg, administered orally with approximately 240 mL water.; Treatment D: GDC-9545/F18 capsule, 30 mg, administered orally with approximately 240 mL water.
Other intervention name(s): Giredestrant; RO7197597; RG6171; Giredestrant; RO7197597; RG6171; Giredestrant; RO7197597; RG6171; Giredestrant; RO7197597; RG6171
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Albanian Versions and Validation of Visual Analogue Scale, Back Pain and Autonomy Questionnaires
Condition: Back Pain; Pain, Acute; Disability Physical
MeSH terms: Back Pain; Acute Pain
Study type: Observational

Summary: 
      A total of 200 participants are predicted to be enrolled for completing questionnaires in
      relation of visual analogue scale, back pain disability and autonomy in Albania. A
      feasibility, validate, test-retest reliability and observational design is estimated.
    

Detailed description: 
      This study consist of two parts, firstly translation and cross-cultural adaptation of pain
      and automaton questionnaires into albanian language and secondly psychometric evaluation of
      the questionnaires including test-retest reliability in Albanian health care centers/
      hospitals .
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Albanian citizens with back pain and with autonomy problems who follows rehabilitation
        sessions in a rehabilitation center.