bioihbjkbjnl/mcl2 huggingface dataset:
Controlled Trial of Panhematin in Treatment of Acute Attacks of Porphyria
Condition: Acute Porphyrias
MeSH terms: Porphyria, Acute Intermittent; Porphyria, Erythropoietic; Porphyrias
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aims to provide high quality evidence for the effectiveness and safety of hemin
      (PanhematinTM , Recordati) for treatment of acute attacks of porphyria. These types of
      studies have not been done before with either PanhematinTM or the hemin preparation available
      in Europe (NormosangTM, Orphan Europe).

      There are two treatment groups in this study. One group will be treated with PanhematinTM
      plus glucose, and the other group will be treated with glucose plus an inactive salt solution
      (called a "placebo"). To avoid prejudice, the treatment given to each participant will be
      blinded (meaning the participants and most of the hospital staff will not know which
      treatment the participant will receive) and randomized (meaning participants will have an
      equal chance of receiving either treatment, like the flip of a coin). A placebo-controlled,
      randomized study is the standard method used to prove treatments are effective and safe.
      PanhematinTM and glucose will be given in the same manner as is usual for treating an attack
      of porphyria. For participants who are chosen to receive the placebo, their treatment will be
      switched to real PanhematinTM at any time if their symptoms do not improve. This is called
      "rescue" treatment, and assures that they study is safe and patients who need hemin will
      receive it. Treatment with hemin will be for 4 days, or longer if needed. Since the study
      treatment is started as soon as possible after symptoms appear, there will be very little
      delay in providing hemin to those who need it. Funding Source - Office of Orphan Products
      Development (FDA OOPD)
    


Intervention name(s): Panhematin; Glucose
Intervention type(s): Biological; Other
Intervention description(s): Glucose loading; Glucose is administered to both groups as routine care.
Other intervention name(s): Glucose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute porphyria; Hemin
Safety and Immunogenicity Study of an Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study is a randomized, double-blinded, and placebo-controlled phase Ia/IIa clinical
      trial of the Inactivated SARS-CoV-2 Vaccine to evaluate the safety and immunogenicity of the
      vaccine in healthy people aged 18~59 Years.
    

Detailed description: 
      This phase Ia/IIa trial is designed to evaluate the safety and immunogenicity of different
      doses of the Inactivated SARS-CoV-2 Vaccine inoculated with different immunization schedules
      based upon the randomized, double-blind and placebo-controlled principle. A total of 942
      subjects aged 18 to 59 years old will be enrolled in the study, of which 192 and 750 will be
      enrolled for phase Ia and phase Ⅱa,respectively.The enrolled subjects in phase Ia receive two
      doses of low-, medium-, or high-dose of experimental vaccines or placebo at an interval of 14
      or 28 days, while the enrolled subjects in Phase Ⅱa receive two doses of medium, high-dose
      experimental vaccines or placebo at an interval of 14 or 28 days.
    

Intervention name(s): Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule; Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule; Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule; Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule; High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule; High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule; Placebo on a 0- and 28-day schedule; Placebo on a 0- and 14-day schedule
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Two doses of low dosage(50U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28; Two doses of low dosage(50U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14; Two doses of medium dosage(100U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28; Two doses of medium dosage(100U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14; Two doses of high dosage(150U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28; Two doses of high dosage(150U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14; Two doses of placebo at the vaccination schedule of day 0,28; Two doses of placebo at the vaccination schedule of day 0,14
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a phase III, multi-centre study of olaparib in combination with paclitaxel,
      compared with placebo in combination with paclitaxel in patients with advanced gastric cancer
      who have progressed following first-line therapy. Patients will be from China, Japan , Korea
      and Taiwan.
    

Detailed description: 
      A randomized, double-blinded, multicentre phase III study to access the efficacy and safety
      of olaparib in combination with paclitaxel, compared with placebo in combination with
      paclitaxel in Asian patients with advanced gastric cancer (including gastro-oesophageal
      junction) who have progressed following first line therapy.
    

Intervention name(s): Olaparib; Paclitaxel; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets-at a dose of 100mg orally twice daily, throughout each cycle (28 days); Once paclitaxel dosing is stopped, the planned monotherapy olaparib dose will be 300mg twice daily.; IV infusion over 1 hour at 80 mg/m2 weekly on days 1, 8 and 15 of a 28 days schedule.; Tablets-at a dose of 100mg orally twice daily, throughout each cycle (28 days); Once paclitaxel dosing is stopped, the planned monotherapy placebo dose will be 300mg twice daily.
Intervention MeSH terms: Paclitaxel; Olaparib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
BOTOX® Efficacy and Safety in the Treatment of Knee Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and safety of a single intra-articular injection of 2
      doses of BOTOX® (onabotulinumtoxinA) compared with placebo as treatment for knee
      osteoarthritis symptoms.
    


Intervention name(s): onabotulinumtoxinA; Normal Saline
Intervention type(s): Biological; Drug
Intervention description(s): onabotulinumtoxinA (botulinum toxin Type A) injection into the intra-articular space of the study knee.; Normal Saline (placebo) injection into the intra-articular space of the study knee.
Other intervention name(s): botulinum toxin Type A; BOTOX®
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison Between Rapid and Slow Palatal Expansion: Evaluation of Periodontal Indices
Condition: Palatal Expansion Technique
Study type: Observational

Summary: 
      The aim of this study is to evaluate the periodontal effects during rapid palatal expansion
      (RPE) or slow palatal expansion (SPE) and to compare them by means of periodontal indices, in
      order to establish the possible differences and advantages of one of these treatments in
      periodontal terms.

      Materials and methods: 10 patients will selected and submitted to RPE treatment; other 10
      patients will selected and submitted to SPE treatment. The patients will treated with the
      Haas appliance. In both the groups the periodontal clinical indices (plaque index, PI;
      papillary bleeding index, PBI; probing pocket depth, PPD) will collected three times during
      the treatment (before, during and at the end). All measurements will performed by the same
      examiner.

      A descriptive statistical analysis will conducted. The paired samples Student's T test will
      used to evaluate the intra-group differences between t1 and t2. The unpaired samples
      Student's T test will used to evaluate between groups differences at t1 and t2. The
      significance level will set at 95%.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients attending the division of orthodontics of Department MeSVA, University of
        L'Aquila, Italy
Comparison of Predictive Factors Related to Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      In Taiwan, heart disease and cerebrovascular disease ranked the second and third of ten
      leading causes of death in female in 2007; half of these deaths is due to coronary artery
      disease (CAD). Postmenopausal status is an independent risk factor for CAD. Early assessment
      and proper management of risk factors may reduce the prevalence rate of CAD. In the past
      decade, despite increased attention to CAD in women, most studies focused on certain
      menopausal status instead of all phases of menopause or on risk factors limited to related
      metabolic syndrome. Because the prevalence of risk factors related to CAD is influenced by
      various physiological and lifestyle status in different menopausal statuses, the purpose of
      this study, at the first stage, is to explore respectively the risk factors of CAD among
      middle-aged women in three menopausal statuses. At the second stage, the influence of a
      lifestyle management program on risk factors modification among pre-menopausal women is
      examined in this study.
    


Intervention name(s): lifestyle modified project
Intervention type(s): Other
Intervention description(s): education, counseling
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: women; middle age; risk factor
Study on the Safety and Effectiveness of Varian ProBeam Proton Therapy Equipment in the Treatment of Solid Tumors
Condition: Solid Tumor; Radiation Therapy; Proton Therapy
MeSH terms: Neoplasms
Study type: Interventional

Summary: 
      This study is a clinical trial of prospective, single-arm objective performance criteria.
      This trial will be conducted in clinical trial sites with a total of 47 subjects enrolled.
      All of subjects will be treated with radiation therapy using the medical device Varian
      ProBeam Proton Therapy System (ProBeam), aim to compare the data with objective performance
      criteria (OPC) to evaluate the effectiveness and safety of ProBeam radiotherapy system for
      oncology patients, providing a clinical basis for the medical device registration.
    

Detailed description: 
      Oncology patients, including tumors of the nervous system, head and neck, chest, abdomen,
      spine, pelvic cavity, limbs and other tumors. The screening period from informed consent to
      enrollment is expected to be 4 weeks, while the treatment period is 1 to 8 weeks. The period
      after the last treatment is divided into short-term follow-up and long-term follow-up, in
      which short-term follow-up will be 3 months after the end of the last treatment. Total
      expected participation for each subject from screening to the completion of short-term
      follow-up is a maximum duration of 12 weeks + 3 months. Long-term follow-up continues after
      the end of short-term follow-up until the 5th year after the end of the last radiotherapy
      session.
    

Intervention name(s): Proton radiation therapy
Intervention type(s): Device
Intervention description(s): Radiation: Proton Therapy System (ProBeam)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: varian; Probeam
Pharmacokinetics and Metabolism of Radiolabeled BMS-690514 in Healthy Male Subjects
Condition: Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine how the human body processes and eliminates the
      drug (BMS-690514.
    


Intervention name(s): EVRI (BMS-690514)
Intervention type(s): Drug
Intervention description(s): Oral Solution, Oral, 200 mg, single dose followed by 10-12 day inpatient stay
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Preoxygenation With Optiflow™ - the Effect of Speech on Lung Oxygenation.
Condition: Unrecognized Condition
Study type: Interventional

Summary: 
      If a patient speaks during the process of preoxygenation with high-flow nasal oxygen via the
      Optiflow™ system, is the efficacy reduced as measured by end-tidal lung oxygen content?
    

Detailed description: 
      This is a randomised controlled trial on 34 patients undergoing routine elective surgery at
      the Princess Anne Hospital, Southampton. The study will take place from September 2018 to
      January 2019 and involve preoxygenating all participants for three minutes using the
      Optiflow™ device. During this time, participants will be instructed to either read aloud a
      standardised text or to breathe through their nose with a closed mouth. At the end of 3
      minutes, the primary outcome, ETO2, will be measured and recorded.
    

Intervention name(s): Optiflow
Intervention type(s): Device
Intervention description(s): 45l.min oxygen
Other intervention name(s): HFNO, High Flow Nasal Oxygen
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients were assigned to either the 'Speech' arm or 'Non-speech' arm of the study
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Optiflow; High Flow Nasal Oxygen; Preoxygenation; Speech
Effects of Black Pepper on the Absorption of Nutrients in Vegetables
Condition: Black Pepper; Absorption; Carotenoid
Study type: Interventional

Summary: 
      The objective of this project is to determine the extent to which eating black pepper
      together with vegetables increase the absorption of carotenoids (a class of important
      nutrients) in the vegetables such as beta-carotene.
    

Detailed description: 
      Black pepper has multiple health-promoting effects, many of which are associated with the
      relatively high levels of piperine it contains. Piperine can enhance the oral bioavailability
      of nutraceuticals in foods due to its inhibitory activity on drug metabolizing enzymes such
      as cytochrome P450 and p-glycoprotein in the gastrointestinal mucosa. This decreases the
      first-pass metabolism of nutraceuticals thus increasing their levels in the systemic
      circulation. Numerous studies in both animals and humans have validated the efficacy of
      piperine in boosting nutraceutical bioavailability. However, most of these studies utilized
      highly purified sources of both piperine and nutraceuticals, and therefore do not provide
      direct evidence on the ability of black pepper (used as a spice) to enhance the
      bioavailability of nutraceuticals in real foods.
    

Intervention name(s): salad dressing (canola oil) and black pepper; salad dressing (canola oil); black pepper; salad; Salad dressing (olive oil) and black pepper; Salad dressing (corn oil) and black pepper; Salad dressing (sunflower oil) and black pepper; Salad dressing (flaxseed oil) and black pepper
Intervention type(s): Other; Other; Other; Other; Other; Other; Other; Other
Intervention description(s): Subjects will consume a vegetable salad with black pepper and dressing (canola oil) one time in the morning; Subjects will consume a vegetable salad with dressing (canola oil) one time in the morning; Subjects will consume a vegetable salad without dressing (canola oil) but with black pepper one time in the morning; Subjects will consume a vegetable salad without dressing (canola oil) and without black pepper one time in the morning; Subjects will consume a vegetable salad with black pepper and dressing (olive oil) one time in the morning; Subjects will consume a vegetable salad with black pepper and dressing (corn oil) one time in the morning; Subjects will consume a vegetable salad with black pepper and dressing (sunflower oil) one time in the morning; Subjects will consume a vegetable salad with black pepper and dressing (flaxseed oil) one time in the morning
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Mindfulness Intervention to Study the Neurobiology of Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The Pediatric Mood Disorders Program at the University of Illinois at Chicago is conducting a
      research study examining how mindfulness can help teenagers stay healthy and prevent
      depression relapse.
    

Detailed description: 
      Study involves:

        -  Brain scan using fMRI technology

        -  Questions about mood and behavior

        -  Meeting with a clinician

        -  Possibility of 8 weekly treatment sessions using mindfulness

        -  Ongoing assessment of depression for next 2 years

      Eligible participants will be compensated for their time.
    

Intervention name(s): Rumination-Focused Cognitive Behavior Therapy
Intervention type(s): Behavioral
Intervention description(s): This intervention targets rumination and other maladaptive forms of emotion regulation such as suppression and avoidance and provides skills training in effective coping strategies. Mindfulness is a key component of this intervention as a strategy for disengaging from one's thoughts. Strategies from Dialectical Behavior Therapy (DBT), such as the use of effective interpersonal skills, are also included as methods for regulating strong emotion. Rumination-Focused Cognitive Behavior Therapy is a structured, manual based program designed to be delivered weekly over eight weeks. Sessions are 60-90 minutes in length.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: mindfulness; relapse prevention; recovery; depression; adolescents
Evaluation and Validation of a Multimodal Brain Function Biomarker With NPC
Condition: Brain Injuries; Concussion, Mild; Concussion, Brain; Near Point Convergence; Concussion, Intermediate
MeSH terms: Brain Injuries; Brain Concussion
Study type: Observational

Summary: 
      This study is designed to collect data which will be used to associate changes in EEG,
      neurocognitive performance, eNPC and clinical symptoms in concussion subtypes. The study will
      recruit males and females, 13-50 years old, from Concussion Centers/Programs, Sports Venues
      and Emergency Departments (ED) across the country, over an 18-month period (Phase 2, 12
      months for Algorithm Development and Norming, and Phase 3, 6 months for Validation).
    

Detailed description: 
      Phase 1 of this project (USAMRDC W81XWH-18-C-0157) was focused on building the
      automated/electronic NPC capability (eNPC). This protocol is for Phase 2, in which the CI
      multimodal brain function biomarker will be extended (Algorithm Development) with the
      inclusion of an automated ocular function measurement (AOFM), to expand the capability in the
      characterization of concussion. The study will also expand the range of applicability of the
      CI to ages 13-50 years old. Phase 2 will also include norming of eNPC across the age range.
      Phase 3 of the project will validate the algorithms developed in Phase 2, using the same
      protocol.
    

Intervention name(s): BrainScope Ahead 300iP-O; SCAT5; Near Point Convergence
Intervention type(s): Device; Diagnostic Test; Diagnostic Test
Intervention description(s): BrainScope study battery consists of four components: recording of brain electrical activity (EEG); three neurocognitive performance tests; an electronic Near Point Convergence measurement assessment and clinical symptom assessments.; Sports Concussion Assessment Tool 5; Manual ocular function measurement conducted only if electronic version on device fails
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male and female study subjects aged 13-50 from participating sites will be invited to
        enroll the study.
      
Keywords: Concussion; Mild Traumatic Brain Injury; Automated/Electronic Near Point Convergence
The Effect of Blood Flow Restriction Applied During Nordic Hamstring Exercise
Condition: Endothelial Dysfunction; Hamstring Injury
Study type: Interventional

Summary: 
      The aim of this study is to investigate the effects of blood flow restriction applied during
      nordic hamstring exercise on neuromuscular activation and endothelial function.
    


Intervention name(s): Blood Flow Restriction
Intervention type(s): Other
Intervention description(s): After randomization, a cuff was placed proximal to one lower extremity. Blood flow was restricted from 60% of the arterial occlusion pressure. The other extremity was determined as the control group. 3x5 nordic hamstring exercises were performed. Surface emg was measured for hamstring muscles during exercise.
Other intervention name(s): Nordic Hamstring Exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized controlled single-blind study
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: blood flow restriction; nordic hamstring exercise; endothelial function; muscular activation