bioihbjkbjnl/mcl2 huggingface dataset:
Dose-Finding Study to Evaluate the Safety, Efficacy, & Tolerability of Multiple Doses of rAvPAL-PEG in Subjects With PKU
Condition: Phenylketonuria
MeSH terms: Phenylketonurias
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate whether weekly injections of phenylalanine ammonia
      lyase (rAvPAL-PEG) can reduce blood phenylalanine concentrations in PKU subjects and whether
      repeated administration is safe.
    

Detailed description: 
      This is a 2 part, Phase 2, open-label dose-finding study in approximately 35 subjects with
      PKU. Seven dose cohorts are planned, each consisting of 5 subjects. In Part 1, the planned
      starting dose levels are those tested in PAL 001 (0.001, 0.003, 0.01, 0.03, 0.1, 0.3, and 1.0
      mg/kg), provided no dose limiting toxicity was observed in PAL 001. In Parts 1 and 2, study
      drug will be administered by clinic staff.

      Subjects who completed participation in PAL 001 will receive priority to participate in PAL
      002. rAvPAL PEG naïve subjects will be enrolled to fill any dose cohort vacancies resulting
      from subjects who did not complete PAL 001 or who chose not to continue into PAL 002. In
      addition, if the number of dose cohorts determined in PAL 001 is less than 7, additional
      naïve subjects may be added to the existing dose cohorts to provide a total of approximately
      35 subjects entering Part 1 of PAL 002. Furthermore, if serial dosing of cohorts in Part 1 of
      PAL 002 is stopped, additional subjects (either naïve subjects or PAL 001 subjects) may be
      added to the existing cohorts so that total study enrollment is approximately 35 subjects. In
      any of these cases, additional subjects will be enrolled sequentially from lowest to highest
      dose cohort.

      Diet will not be altered during the course of this study, except as necessary for safety.

      Subjects will be evaluated for safety and for blood Phe concentrations throughout the study.
      Toxicity will be measured according to the National Cancer Institute (NCI) Common Terminology
      Criteria for Adverse Events (CTCAE), version 3.

      A Data Monitoring Committee will monitor the study.
    

Intervention name(s): rAvPAL-PEG 0.001 mg/kg; rAvPAL-PEG 0.003 mg/kg; rAvPAL-PEG 0.01 mg/kg; rAvPAL-PEG 0.03 mg/kg; rAvPAL-PEG 0.1 mg/kg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): In Part 1, the planned starting dose levels is 0.001 mg/kg; In Part 1, the planned starting dose levels is 0.003 mg/kg; In Part 1, the planned starting dose levels is 0.01 mg/kg; In Part 1, the planned starting dose levels is 0.03 mg/kg; In Part 1, the planned starting dose levels is 0.1 mg/kg
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PKU; PEG PAL; BioMarin
Cost Effectiveness of Prolotherapy Injections Prior to Total Knee Arthroplasty
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      This study compared the cost effectiveness of two-stage algorithm (prolotherapy injections
      (PrT) combined with rehabilitation protocol (RP) prior to total knee arthroplasty (TKA)) and
      one-stage algorithm (TKA) in the management of advanced stage knee osteoarthritis.
    

Detailed description: 
      The aim of the present study was to compare the cost effectiveness of two-stage algorithm
      (prolotherapy injections (PrT) combined with rehabilitation protocol (RP) prior to total knee
      arthroplasty (TKA)) and one-stage algorithm (TKA) in the management of advanced stage knee
      osteoarthritis.

      A total of 197 patients who had chronic knee osteoarthritis were included in the present
      study. The patients were divided into two groups as two-stage algorithm (PrT combined with RP
      prior to TKA), (Group A, n=98) and one-stage (TKA),(Group B, n=99). Clinical effectiveness
      was evaluated via Visual Analog Scale (VAS), The Western Ontario and McMaster Universities
      Arthritis Index (WOMAC) at baseline and 3-, 6-, 12-, and 18-month follow-ups. Utility scores
      of the groups were obtained by extracting and converting WOMAC scores to health utilities
      index mark 3 scores. Cost-utility per quality-adjusted life years (QALY) and Incremental
      cost-effectiveness ratios (ICERs) of each group were calculated.
    

Intervention name(s): total knee arthroplasty
Intervention type(s): Procedure
Other intervention name(s): injection; prolotherapy
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Age of the patients varied between 50 and 90
      
Keywords: Arthroplasty; Prolotherapy; Osteoarthritis
Safety Evaluation of a Lifestyle Modification Program In.Form 1.1
Condition: Obesity
Study type: Interventional

Summary: 
      The study evaluated and compared the safety, tolerance and acceptability of a lifestyle
      modification program with or without nutritional supplementation in generally healthy
      overweight subjects with cardiometabolic risk factors.
    

Detailed description: 
      To investigate the safety, tolerance and acceptability of a low-glycemic load diet combined
      with exercise and lifestyle modification education (DIET) or a similar program with a meal
      replacement formula and targeted nutraceuticals (PROG) in generally healthy, overweight
      subjects, forty to fifty subjects with two or more cardiometabolic risk factors, aged 18 to
      69 will be randomized into different arms, 13-week intervention trial. To evaluate safety and
      tolerability, questionnaires were collected weekly. Additionally, baseline, week 9 and 13
      fasting blood samples will be drawn for blood counts, metabolic profiles, plasma lipids, and
      additional cardiovascular risk factors. Vitals signs, weight and body composition were
      monitored weekly.
    

Intervention name(s): PROGRAM; DIET
Intervention type(s): Dietary Supplement; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Use of Repetitive Magnetic Stimulation for Strength Training of the Quadriceps Muscle
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      We intend to use repetitive magnetic stimulation to the quadriceps muscle to try to improve
      strength and improve the metabolic function of the muscle.
    

Detailed description: 
      Quadriceps strength is reduced in COPD. Increasing quadriceps strength is one of the goals of
      pulmonary rehabilitation yet some patients with severe COPD are unable to exercise with
      sufficient intensity, due to breathlessness, to achieve a true training benefit.

      Transcutaneous electrical stimulation of the femoral nerve has been shown to improve
      quadriceps muscle strength, muscle mass, and performance in patients with severe COPD.
      Magnetic stimulation may be preferred because it offers the opportunity to train the whole
      muscle and because it is painless. In this pilot study we are investigating whether
      repetitive magnetic stimulation camn increase the strength of the quadriceps muscle and
      whether it confers any change in structure or metabolism of the muscle itself.
    

Intervention name(s): Repetitive magnetic stimulation to the quadriceps
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neuromuscular electrical stimulation
Phenoxodiol Combined With Either Cisplatin or Paclitaxel in Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Condition: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial; Fallopian Tube Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different
      ways to stop tumor cells from dividing so they stop growing or die. Phenoxodiol may help
      cisplatin and paclitaxel kill more tumor cells by making tumor cells more sensitive to the
      drugs.

      PURPOSE: This randomized phase I/II trial is studying the side effects of phenoxodiol when
      given together with either cisplatin or paclitaxel and to see how well they work in treating
      patients with recurrent late-stage ovarian epithelial cancer, fallopian tube cancer, or
      primary peritoneal cancer that has not responded to treatment with drugs such as paclitaxel,
      docetaxel, cisplatin, or carboplatin.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Compare the safety and tolerability of phenoxodiol combined with cisplatin or paclitaxel
           in patients with recurrent late-stage ovarian epithelial, fallopian tube, or primary
           peritoneal cancer that is refractory or resistant to platinum and/or taxane drugs.

        -  Compare, preliminarily, tumor response in patients treated with these regimens.

      OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1
      of 2 treatment arms according to medical history.

        -  Arm I: Patients receive phenoxodiol IV over 10 minutes on days 1 and 2 and cisplatin IV
           over 1 hour on day 2.

        -  Arm II: Patients receive phenoxodiol as in arm I and paclitaxel IV over 1 hour on day 2.

      In both arms, treatment repeats every 6 weeks for up to 8 courses in the absence of disease
      progression or unacceptable toxicity.

      Quality of life is assessed at 12, 24, 36, and 48 weeks or at the end of study participation.

      Patients are followed at 6 and 12 months.

      PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this
      study.
    

Intervention name(s): cisplatin; paclitaxel; phenoxodiol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IV 40 mg/m2 on Day 2 Number of Cycles: until progression or unacceptable toxicity or other withdrawal criteria are met.; IV 80 mg/m2 on Day 2 Number of Cycles: until progression or unacceptable toxicity or other withdrawal criteria are met.; IV 3 mg/kg
Intervention MeSH terms: Paclitaxel; Cisplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent ovarian epithelial cancer; fallopian tube cancer; primary peritoneal cavity cancer
Safety and Immunogenicity Study of a Recombinant Protein Vaccine (NDV-3) Against S.Aureus and Candida
Condition: Staphylococcal Infections; Candidiasis
MeSH terms: Infections; Candidiasis; Staphylococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, placebo-controlled study is a first-in-human Phase 1 study
      using two dose levels of an investigational vaccine directed against S. aureus and Candida.
      The study is designed to evaluate the safety, tolerability and immunogenicity of the
      investigational vaccine, NDV-3
    

Detailed description: 
      Preclinical studies in mice have established that several members of the Als family of
      proteins induce a protective immune response in mice and allow high survival rates following
      challenge with highly virulent doses of either Candida or S. aureus. Als3 (the antigen in the
      NDV-3 investigational vaccine) is the most effective member of the Als protein family in
      protecting mice from challenge with either Candida or S. aureus. This Phase I study will
      evaluate the safety and immunogenicity of a two doses administered 6 months apart of NDV-3
      vaccine at two dose levels. At least 40 subjects will be enrolled in the study in two groups
      of approximately 20 subjects each. Each group will be randomized so that 15 will receive
      NDV-3 vaccine and 5 will receive placebo. All injections will be administered
      intramuscularly. One group will receive a low dose of NDV-3 and the other a ten-fold higher
      dose. Subjects will have follow-up visits to assess the safety, tolerability and immune
      responses at days 3, 7, 14, 28, 90 and 180 after the first vaccination to compare to baseline
      levels and at days 7, 14 and 90 after the second vaccination.
    

Intervention name(s): NDV-3 investigational vaccine
Intervention type(s): Biological
Intervention description(s): Two doses of vaccine 6 months apart or placebo(only one dose at Time 0) administered intramuscularly
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: NDV-3; vaccine; Staphylococcus aureus; MRSA; Candida
Cross-training Effect of Whole-body Vibration
Condition: Muscle Physiology
Study type: Interventional

Summary: 
      This study evaluates whether an increase in the ipsilateral knee flexor muscle strength
      transfers to the contralateral knee extensors which are not exposed to vibration, when
      unilateral-isolated whole body vibration (WBV) is applied to the lower extremity. In the half
      of volunteers the right leg were exposed vibration, while in the other half the right leg
      were exposed sham vibration. Muscle strength were measured with the Cybex® (Massachusetts,
      USA) extremity-testing system.
    

Detailed description: 
      This study was included 40 healthy volunteers. The change in the quadriceps muscle strength
      after 20 session of WBV exercises was evaluated this study. In the WBV group, 20 sessions of
      unilateral lower extremity vibration exercises were performed with the Whole Body Vibration
      (WBV) device. WBV was applied when the subjects are in the semi-squat position. WBV was
      implemented with Powerplate® Pro5 (PowerPlate® International Ltd, London, United Kingdom).
      During 20 sessions, the WBV amplitude and vibration time were increased gradually. In the
      first session, the subjects were do a 30-second, 30-35, 40- and 45-Hz low-amplitude WBV while
      the knee and hip joint were in 30 degrees of flexion (in the semi-squat position); 10-second
      rest period between vibration applications were applied. A total duration of WBV was be two
      minutes. In the 20th session, the subjects were given a 60-second, 30-, 35-, 40- and 45-Hz
      high-amplitude WBV while the knee and hip joint were in 45 degrees of flexion; 10-second rest
      period between vibration applications were applied. A total duration of WBV was eight
      minutes. During WBV, the left lower extremity was in the knee-hip flexion position but was
      not exposed the vibration.

      The same experimental protocol was applied to the isometric exercise (control) group. Unlike
      the experimental group, sham vibration was applied to the control group. Before and after 20
      session-exercise, both knee extensor isokinetic muscle strength was measured.
    

Intervention name(s): Whole body vibration; Sham vibration
Intervention type(s): Device; Device
Intervention description(s): Whole body vibration was applied on the right lower extremity in the experimental group.; Sham vibration was applied on the right lower extremity in the Control sham group
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental group was exposed WBV, Control group was exposed sham WBV
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
IGF-1, Sarcopenia and Mortality: a Cohort Study in Patient With Cognitive Impairment
Condition: Cognitive Impairment; Insulin-like Growth Factor 1
MeSH terms: Sarcopenia; Cognitive Dysfunction
Study type: Observational

Summary: 
      Insulin-like growth factor 1 (IGF)-1 is an important neuromyotrophic hormone. Disregulation
      of this hormone has been reported to influence the genesis of cognitive impairment and
      dementia in the elderly patients. We analyzed the possible link between IGF-1 and risk of
      Sarcopenia and Mortality in a cohort of elder patients with cognitive impairment.
    


Intervention name(s): IGF-1 serum value
Intervention type(s): Procedure
Intervention description(s): Evaluation of IGF-1 serum value at baseline, 24 and 48 months
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Consecutive patients were enrolled from orthopedics clinic (IRCCS Galeazzi Milan) and
        geriatric day service (Sapienza University of Rome)
      
Keywords: sarcopenia; mortality
The Effect of Aromatherapy Applied to the Patients in the Urodynamic Procedure
Condition: Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This randomized controlled study is planned to determine the effect of aromatherapy applied
      to patients in the urodynamic procedure on patients' anxiety and serum cortisol levels.

      This study assumes that lavender inhalation in aromatherapy has positive effects on
      physiological parameters such as blood pressure, heart rate, respiratory rate, serum cortisol
      level, as well as reducing stress and anxiety.
    

Detailed description: 
      98 patients in each group will be included in the study (Aromatherapy group=49; Control
      group=49). In addition to the routine treatment and care practices of the unit, aromatherapy
      will be applied to the patients included in the study group. Aromatherapy application will be
      applied to all patients by the same researcher. Aromatherapy application will be started 5
      minutes before the urodynamic procedure after the patient is taken to the urodynamics room
      and lavender essential oil will be used with a diffuser until the end of the procedure.
      Routine treatment and care interventions will be applied to the patients included in the
      control group during the procedure.
    

Intervention name(s): Aromatherapy
Intervention type(s): Other
Intervention description(s): Patients in the study group will rest for 5 minutes before and after the urodynamics procedure. All patients will be asked to fill in the 'Spielberger State Anxiety Scale' before and after the urodynamic procedure. Before and after the procedure, blood pressure, heart rate, respiratory rate, peripheral oxygen saturation will be measured. Blood will be drawn for serum cortisol level. In addition to the routine treatment and care practices of the unit, aromatherapy will be applied to the patients included in the study group. Aromatherapy application will be applied to all patients by the same researcher. Aromatherapy application will be started 5 minutes before the urodynamic procedure after the patient is taken to the urodynamic room, and lavender essential oil (3 drops in 300 cc water for 5 cubic meters of room) will be used with a diffuser until the end of the procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Anxiety; Aromatherapy; Urodynamic; Serum Cortisol
PK and Safety of SCT510
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, parallel-controlled phase I clinical study comparing the
      pharmacokinetics, safety and immunogenicity of SCT510 with bevacizumab (Avastin®) in Chinese
      healthy males.
    

Detailed description: 
      Eighty-four subjects randomly (1:1) received a 3 mg/kg dose of SCT510 or bevacizumab infusion
      for 90 min and followed up for 99 days. The screening period of this study is 14 days.
      Subjects will be admitted to the research center on day-1 and will be allowed to leave the
      research center with relevant observation and evaluation on day 5 (96 hours) after the
      completion of the administration. Subjects were asked to return for 10 follow-up visits
      respectively according to this research protocol, on the day 8, day 15, day 22, day 29, day
      43, day 57, day 64, day 71, day 85 and day 99.

      All subjects in each group will be blinded after blood/urine collection and safety
      evaluation.

      Blood samples will be tested by a validated LC/MS method for pharmacokinetic study.
    

Intervention name(s): SCT510; Bevacizumab
Intervention type(s): Drug; Drug
Intervention description(s): Subjects received a single intravenous infusion (3 mg/kg) of SCT510 for 90 minutes , and the volume of administration was calculated based on the subject's weight.; Subjects received a single intravenous infusion (3 mg/kg) of bevacizumab for 90 minutes , and the volume of administration was calculated based on the subject's weight.
Intervention MeSH terms: Bevacizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: pharmacokinetics; immunogenicity; biosimilar; phase I; anti-VEGF monoclonal antibody
The EUS ShearWave Elastography Liver Fibrosis Study
Condition: Liver Fibroses
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Observational

Summary: 
      The study objective is to demonstrate the clinical performance of ShearWave Elastography
      (SWE) in Endoscopic Ultrasound (EUS) when compared to FibroScan for evaluation of liver
      fibrosis.
    

Detailed description: 
      This study has been designed as prospective, single center, single arm, consecutive, blinded,
      pilot study conducted in a post-market setting using commercially available devices to
      evaluate the effectiveness of Endoscopic Ultrasound with ShearWave Elastography to estimate
      hepatic fibrosis in patients with chronic liver disease. It is anticipated that the data from
      this study will support the need for additional clinical trials. All consenting, eligible
      patients reporting for an ultrasound and/or liver biopsy for evaluation of fibrosis meeting
      the inclusion criteria will be consecutively enrolled into the study and assigned a unique
      study identification number. A total of 52 subjects will be enrolled and treated at a single
      study site in the US. Enrollment is expected to be completed within 6 months. Each subject
      will undergo both procedures (FibroScan and EUS with SW Elastography), End of study will be
      reached after pathology results have been obtained (within a week of the initial procedure).
    

Intervention name(s): ShearWave Elastography (SWE) in Endoscopic Ultrasound (EUS); FibroScan; ALOKA ARIETTA 850 -
Intervention type(s): Device; Device; Device
Intervention description(s): ShearWave Measurement is a software option available on the ARIETTA 850 that uses transient pulses to generate shear waves in the body. The tissue's elasticity is directly deduced by measuring the speed of wave propagation.; manufactured by Echosens; manufactured by Hitachi Healthcare - included on the system is the ShearWave measurement software
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All consenting, eligible patients reporting for an ultrasound and/or liver biopsy for
        evaluation of fibrosis.