bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Three Liraglutide Formulations in Healthy Volunteers
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Oceania. The aim of this trial is to test for bioequivalence
      between each of the two new liraglutide formulations at pH 7.9 and 8.15 and the planned Phase
      3 formulation at pH 7.7.
    


Intervention name(s): liraglutide
Intervention type(s): Drug
Intervention description(s): One single dose of 0.75 mg administered on three different dosing occasions with a 14-day wash-out period between each dosing. Injected subtaneously
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
AZD8848 Single Ascending Dose Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics
      of single ascending doses of AZD8848 in healthy subjects.
    

Detailed description: 
      A Double-blind, Placebo-controlled, Randomised Study to Investigate the Safety, Tolerability,
      Pharmacokinetics and Pharmacodynamics of Single Ascending Inhaled Doses of AZD8848 in Healthy
      Subjects
    

Intervention name(s): AZD8848; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose, oral inhalation (nebuliser solution); Single dose, oral inhalation (nebuliser solution)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Safety; tolerability; healthy; pharmacokinetic; pharmacodynamic; inhaled
Treatment of Pulmonary Fibrosis Due to COVID-19 With Fuzheng Huayu
Condition: Pulmonary Fibrosis Due to COVID-19
MeSH terms: COVID-19; Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      According to previous studies, viral pneumonia can develop into pulmonary fibrosis, which can
      affect patients'lung function and even life health.This study aims to observe the efficacy
      and safety of Fuzheng Huayu Tablets in the treatment of pulmonary fibrosis after COVID-19.
    

Detailed description: 
      The patients with COVID-19 could suffered from the pulmonary dysfunction and/or fibrosis the
      recovery period, but there are no certain drugs or treatment to cope with this situation. Our
      previous studies indicated that Fuzheng Huayu tablets (FZHY) could regress the lung fibrosis
      induced by bleomycin in animals, and improve the pulmonary function in the patients with
      chronic obstructive pulmonary disease. Now we design this trial to carry out the clinical
      study in order to evaluate the effects of Fuzheng Huayu tablets on pulmonary fibrosis and/or
      pulmonary function injury in the recovery period of COVID-19 and expect to improve the
      prognosis.

      This is a randomized, double-blind, multicenter, placebo-controlled clinical trial.It enrolls
      142 patients who had been diagnosed with COVID-19, but currently they are negative for viral
      testing and have developed pulmonary fibrosis or pulmonary dysfunction. They are randomly
      assigned into Placebo group and FZHY group. All patients are given usual treatment such as
      respiratory function rehabilitation training and vitamin C. The FZHY group is given Fuzheng
      Huayu tablets, and the control group is given placebo. Each patient will be observed for 24
      weeks and followed up for 8 weeks. The primary outcomes for the trial are the improvement
      proportion of pulmonary fibrosis judged by HRCT score and the improvement of lung
      function(FVC,FEV1,FVC/FEV1). Secondary outcomes include six-minute walk distance, improvement
      proportion of pulmonary inflammation, improvement proportion of clinical symptoms , quality
      of Life-BREF (QOL-BREF) Score, patient health questionnaire-9 (PHQ-9) Score, general anxiety
      disorder-7 (GAD-7) score. The safety also be observed.
    

Intervention name(s): Fuzheng Huayu Tablet; Vitamin C tablets; Placebo; respiratory function rehabilitation training
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): FZHY, administration: 0.4g/tablet, 1.6g/time, 3 times/day, oral; administered half an hour after the meal.; Vitamin C tablets, administration: 0.2g/time, 3 times/ day, oral；; Placebo , administration: 0.4g/tablet, 1.6g/time, 3 times/day, oral; administered half an hour after the meal.; Health exercise, once a day
Other intervention name(s): FZHY; VC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Pharmacokinetics Following Single-dose of Valsartan in Japanese Pediatric Patients
Condition: Hypertension; Chronic Kidney Disease; Nephrotic Syndrome
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Nephrotic Syndrome; Nephrosis; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the pharmacokinetics and safety following single dose of valsartan in
      Japanese pediatric patients with hypertension, chronic kidney disease, or nephrotic syndrome.
    


Intervention name(s): Valsartan (VAL489)
Intervention type(s): Drug
Intervention MeSH terms: Valsartan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Hypertension, chronic kidney disease; nephrotic syndrome; pharmacokinetics
A Study to Evaluate Pharmacokinetic (PK) and Safety of GSK1265744 in Subjects With Hepatic Impairment and Control Healthy Volunteers
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a Phase 1, open-label, parallel group, two-part, single-dose adaptive study in
      adults with moderate and mild (if needed) hepatic impairment and matched, healthy control
      subjects with normal hepatic function. In Part 1, healthy control subjects (n=8) matched to
      subjects with moderate (n=8) hepatic impairment will be enrolled. If the geometric mean total
      plasma area under the concentration-time curve from time zero (pre-dose) extrapolated to
      infinite time (AUC[0-infinity]) of GSK1265744 is increased by >2-fold in moderately impaired
      subjects relative to matched controls, Part 2 will be conducted to evaluate GSK1265744 PK in
      subjects with mild hepatic impairment (n=8) and matched, control subjects (n=8). All subjects
      will receive a single 30 milligram (mg) oral dose of GSK1265744. The primary objective of the
      study is to compare plasma PK parameters of GSK1265744 in subjects with hepatic impairment to
      healthy controls matched in gender, age, and body mass index (BMI).
    


Intervention name(s): GSK1265744 30mg
Intervention type(s): Drug
Intervention description(s): GSK1265744 30mg tablets are white to almost white coated oval tablets. All subjects will receive GSK1265744 30mg as a single oral dose in the fasted state followed by PK sampling.
Intervention MeSH terms: Cabotegravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GSK1265744; healthy controls; pharmacokinetic; Hepatic Impairment
Telerehabilitation Following Ankle Fractures
Condition: Ankle Fractures
MeSH terms: Fractures, Bone; Ankle Fractures
Study type: Interventional

Summary: 
      Background and Purpose: Ankle fractures represent one of the most common fractures in North
      America. Surgical fixation is often required in the presence of dislocation or instability
      and has been shown to have a high rate of success. Following surgical fixation, physical
      therapy is commonly utilized to assist in regaining function. Advice alone has been shown to
      be non-inferior to traditional physical therapy for patients post-ankle fracture in two
      studies. The results of these studies have yet to be repeated in the US. It is the intent of
      this study to investigate the feasibility of a large clinical trial comparing the results of
      traditional physical therapy and an internet-based telerehabilitation program. Following
      surgical repair of ankle fractures, patients will be randomized to traditional rehabilitation
      or telerehabilitation. Telerehabilitation may represent an alternative patient option to
      traditional physical therapy following ankle fracture repair. The results of this study will
      inform the design of larger multi-site clinical trials investigating the effectiveness of
      telerehabilitation for this patient population.
    


Intervention name(s): Telerehabilitation; Standard rehabilitation
Intervention type(s): Other; Other
Intervention description(s): Internet-guided rehabilitation with weekly phone calls from a physical therapist.; Prescription for physical therapy and a printed list of exercises to complete.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rehabilitation; Telerehabilitation
FOLFOXIRI as Primary Treatment for Locally Advanced Pancreatic Cancer
Condition: Pancreatic Carcinoma Stage III
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is conducted as a monocentric prospective phase II trial. Patients with
      unresectable stage III locally advanced pancreatic cancer (defined for extended encasement of
      superior mesenteric artery/celiac axis/hepatic artery or for combined venous and arterial
      involvement or for unreconstructible venous encasement), ECOG PS 0-1 and age 18-75 are
      eligible.

      After multidisciplinary evaluation of resectability, treatment with FOLFOXIRI is provided for
      a maximum of 12 cycles with multidisciplinary evaluation of disease status every 4 cycle.

      In case of tumors have deemed resectable surgery is considered. In case tumors remain
      unresectable, radiotherapy is evaluated after the end of chemotherapy.

      Primary objective of the study is the rate of patients who become resectable and undergo
      radical surgical resection after chemotherapy.

      Secondary objectives are: response rate, progression-free survival, overall survival,
      toxicity.
    


Intervention name(s): FOLFOXIRI
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Multi-Center Study of the Efficacy, Pharmacokinetics (PK) and Pharmacodynamics (PD) of IV Acetaminophen for the Treatment of Acute Pain in Pediatric Patients
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the efficacy and safety of Intravenous (IV)
      acetaminophen plus rescue opioids for the relief of moderate to severe acute pain in neonates
      and infants (age < 2 years) compared to placebo plus standard of care rescue opioids as well
      as characterize the concentration-effect relationship (PK/PD) of the intravenous
      acetaminophen as compared to the control group.
    


Intervention name(s): IV Acetaminophen; IV Control
Intervention type(s): Drug; Drug
Intervention description(s): IV Acetaminophen given every 6 hours (q6h); 4 doses, in 24 hours; IV Control q6h; 4 doses, in 24 hours
Other intervention name(s): OFIRMEV; Saline; Placebo
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Moderate to severe acute pain following surgery or trauma
Clinical Trial to Investigate the Efficacy and Safety of LN-OS-22 on Oxidative Stress and Systemic Inflammation in Overweight and Obese Population.
Condition: Oxidative Stress
MeSH terms: Overweight; Inflammation
Study type: Interventional

Summary: 
      The present clinical investigation has been proposed to further substantiate the evidence of
      the antioxidant and anti-inflammatory activity of the extract in the healthy adult population
      with BMI ranging from ≥25.0 kg/m2 and ≤ 34.9 kg/m2 . The antioxidant effect of the 56 days of
      oral administration of the extract (1000 mg/day) will be primarily assessed by change in the
      level of 8-isoprostane from baseline to the end of the study and the anti-inflammatory
      activity of the extract will be investigated by the change in the level of CRP and IL-6. In
      addition, the effect on lipid peroxidation and DNA damage will be assessed by serum level of
      MDA before and after 2 months of extract administration. Further, metabolic endotoxemia will
      be assessed by the change in the plasma level of lipopolysaccharides. Weight and waist
      circumference are included as secondary outcomes as the clinical indicators of reduction in
      oxidative stress and inflammation. Overweight and obesity significantly impact the
      health-related quality of life31 in the affected individuals and flavonoids have previously
      been shown to improve the quality of life in controlled clinical studies therefore,
      Investigator included health-related quality of life as a secondary objective of the study.
      The safety of the 2-month administration of the extract will be examined by a change in the
      vitals, liver, and kidney function biomarkers (SGOT, SGPT, ALP, and creatinine).
    


Intervention name(s): LN-OS-22; Maltodextrin
Intervention type(s): Other; Other
Intervention description(s): 2 capsules orally once a day to be taken with a glass of milk after breakfast for 56 days; 2 capsules orally once a day to be taken with a glass of milk after breakfast for 56 days
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo-controlled parallel-group
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Study of the Effectiveness of The COVID-19 Vaccine
Condition: COVID-19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      This descriptive study examines neutralizing antibody levels against COVID-19 in health
      workers before and after the 2nd booster of the COVID-19 vaccine in Surakarta, Indonesia.
    

Detailed description: 
      This research is a cross-sectional study with a descriptive-analytic design, community-based,
      of adults who live in Surakarta (age 18 years and over) using the Google form. The inclusion
      criteria were health workers receiving the third or second dose of the COVID-19 vaccine.
      Quantitative antibody titers are checked at Prodia's laboratory. Other variables examined
      were the number and date of vaccination, age, sex, comorbid diseases, body mass index, AEFI
      symptoms after the vaccine, and history of being infected with COVID-19. In the statistical
      analysis using the different and regression correlation tests, the significance level of P is
      less than 0.05.
    

Intervention name(s): COVID-19 Antibody
Intervention type(s): Diagnostic Test
Intervention description(s): This descriptive study examines the levels of neutralizing antibodies against COVID-19 in health workers before and after the Quantitative Anti-SARS-CoV-2 Test is an examination to measure in vitro quantitative antibodies (including IgG) against the receptor binding domain (RBD) of the SARS-CoV Spike (S) protein. -2, which aims to assess the adaptive humoral immune response to the SARS-CoV-2 Spike protein. Measurement with the ECLIA method. Ratio Scale after the 2nd booster COVID-19 vaccine in Surakarta, Indonesia.
Other intervention name(s): COVID-19 Immunoglobulin
Intervention MeSH terms: Antibodies; Immunoglobulins
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Health worker in Universitas Sebelas Maret Hospital, Surakarta, Indonesia
      
Keywords: COVID-19 Vaccine, Health Worker
The Trial of Ewata Balloon Guiding in the Application of Thrombectomy
Condition: Acute Ischemic Stroke
MeSH terms: Ischemic Stroke
Study type: Interventional

Summary: 
      To evaluate the efficacy and security of Ewata combined with a stent device in the treatment
      of acute ischemic stroke within 8 hours To prove whether the clinical efficacy and safety of
      Ewata r is not inferior to other guidings.
    

Detailed description: 
      This clinical trial uses multicenter, single-arm, prospective trial design,people who met the
      enrollment requirements were performed with Ewata balloon guiding and stent type thrombectomy
      device.The clinical results were compared with those of other historical guiding catheter
      products combined with the stent type thrombectomy device to to evaluate the clinical
      efficacy and safety of Ewata balloon guide catheter in combination with a stent for
      thrombectomy.
    

Intervention name(s): Ewata balloon guiding
Intervention type(s): Device
Intervention description(s): The balloon guide catheter is coaxial cavity and reinforced braided catheter with varying stiffness echelon.The distal end is marked by an impermeable ray, the proximal end has a bifurcated ruhr interface, and the end is embedded with a compliance balloon.The product label indicates the size of the balloon guide catheter and the maximum volume of the balloon.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: AIS balloon guiding
Transcutaneous Vagal Nerve Stimulation: Influence on miRNA, Inflammation, Cerebral Resting State and Gastric Motility
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Randomized, double-blind trial to investigate the influence of a single 4 hours episode of
      transcutaneous vagal nerve stimulation on the expression of microRNA, various cytokines,
      chemokines, neuropeptides, cerebral resting state and gastric motility in healthy volunteers.
    

Detailed description: 
      Transcutaneous vagal nerve stimulation (tVNS) is a non-invasive treatment option for
      epilepsy. TVNS works via electrical stimulation of the vagal nerve in the outer ear area via
      two steel electrodes and is performed for about 4 hours per day. Its mechanism of action is
      unknown. We hypothesize that expression of microRNA (miRNA), and/or release of cytokines,
      chemokines or neuropeptides is involved in the anticonvulsant activity. TVNS might also
      influence the cerebral resting state as measured by functional magnetic resonance imaging
      (fMRI). Due to it's anatomical connections, stimulation of the vagal nerve may furthermore
      result in altered gastric motility.

      This study aims to detect levels of miRNA, cytokines, chemokines and neuropeptides in the
      blood of healthy volunteers before and after 4 hours of conventional tVNS or sham tVNS.
      Cerebral resting state and gastric motility will be measured by fMRI.

      To this end, 60 healthy volunteers will be recruited and divided into 2 groups. 30 healthy
      volunteers will be treated with tVNS (25 Hz) for 4 hours (tVNS group). 30 healthy volunteers
      will be treated with sham tVNS (1 Hz) for 4 hours (control group).

      On day 1 of the study, participants will be randomized to one of the two groups. Blood will
      be drawn from all participants at baseline. Both groups receive a standardized breakfast.
      TVNS ear electrodes will be put into place for 4 hours without electrical stimulation.
      Thereafter, blood will be drawn.

      On day 2 of the study, blood will be drawn, and all participants receive a standardized
      breakfast again. Afterwards, tVNS (25 Hz) will be performed in participants of the tVNS
      group, and sham tVNS (1 Hz) will be performed in participants of the control group. TVNS or
      sham tVNS end after 4 hours. Blood will be drawn immediately after stimulation end.
      Thereafter, MRI will be performed in all participants (fMRT resting state, gastric motility).
      This ends the study for the participant.
    

Intervention name(s): Transcutaneous vagal nerve stimulation
Intervention type(s): Device
Intervention description(s): 4 hours of transcutaneous vagal nerve stimulation
Other intervention name(s): NEMOS tVNS device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Vagus Nerve Stimulation
Pharmacokinetic and Pharmacoscintigraphic Comparison of TobrAir® 6.0 With TOBI® and TOBI® Podhaler™
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study compares pharmacokinetic profiles of tobramycin delivered by TobrAir® 6.0 device
      with TOBI® nebulizer system and the TOBI® Podhaler™ device. In addition, lung deposition of
      tobramycin delivered by TobrAir® 6.0 device and by TOBI® nebulizer system will be determined.
    

Detailed description: 
      This is an open-label, randomized, single dose, cross-over study in healthy subjects. Each
      subject receives tobramycin with 3 different inhalation devices:

        -  75 mg tobramycin delivered to the airways via TobrAir® 6.0.

        -  300 mg tobramycin (TOBI®) delivered to the airways via the PARI LC® PLUS/PARI TurboBoy®
           SX.

        -  112 mg tobramycin (4x28mg dry powder capsules) delivered to the airways via the TOBI®
           Podhaler™.

      Each dose is separated by a minimum washout of at least 68 h.

      Blood samples for PK analysis of tobramycin will be collected at regular time intervals until
      24 h post-dose. For TobrAir 6.0 and TOBI/PARI only, all dosed subjects will undergo
      scintigraphic assessments.
    

Intervention name(s): Tobramycin
Intervention type(s): Drug
Intervention MeSH terms: Tobramycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteers
Safety and Efficacy of LibiGel® for the Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women
Condition: Hypoactive Sexual Desire Disorder
MeSH terms: Hypokinesia; Sexual Dysfunctions, Psychological
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a randomized, double-blind, placebo-controlled, multi-center study of the
      safety and efficacy of LibiGel® 300mcg in the treatment of HSDD in surgically menopausal
      women
    


Intervention name(s): testosterone gel; placebo gel
Intervention type(s): Drug; Drug
Intervention description(s): once daily transdermal testosterone gel, 300 mcg; once daily transdermal placebo gel
Other intervention name(s): LibiGel
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: hypoactive sexual desire disorder; testosterone; menopause