bioihbjkbjnl/mcl2 huggingface dataset:
Effect of BIA 5 1058 on Cardiac Repolarization
Condition: Cardiovascular Disease; Pulmonary Arterial Hypertension; Heart Failure
MeSH terms: Pulmonary Arterial Hypertension; Hypertension; Heart Failure; Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose is to evaluate the effect of single therapeutic (400 mg) and supratherapeutic
      (1200 mg) doses of BIA 5-1058 on the time-matched change from baseline in placebo-adjusted
      interval corrected (QT) for heart rate (HR)
    

Detailed description: 
      This will be a Phase 1, randomized, double-blind, placebo-controlled and open-label, active
      controlled, 4 period, crossover study in healthy male and female subjects under fed
      conditions.

      The study will be double blinded for BIA 5-1058 and placebo and open label for moxifloxacin.
      The central ECG laboratory and ECG readers will be blinded to study treatment sequence,
      timepoint, and subject. All subjects will receive each of the following 4 treatments:

        -  400 mg BIA 5 1058

        -  1200 mg BIA 5 1058

        -  placebo

        -  400 mg moxifloxacin

      Potential subjects will be screened to assess their eligibility to enter the study between 28
      and 3 days prior to the first treatment administration. For each treatment period, subjects
      will be admitted into the Clinical Research Unit (CRU) on Day 2 and be confined to the CRU
      until Discharge on Day 4. Each subject will receive a single dose of study medication on Day
      1 of each treatment period. There will be a washout of at least 10 days between doses, and
      subjects will return to the CRU for a Follow-up visit 14 ± 2 days after Period 4 Discharge.
      The total duration of study participation for each subject from Screening through Follow-up
      visit) is anticipated to be approximately 80 days.

      The start of the study is defined as the date the first enrolled subject signs an Informed
      Consent Form (ICF). The point of enrollment occurs at the time of subject number allocation.
      The end of the study is defined as the date of the last subject's last assessment (scheduled
      or unscheduled).
    

Intervention name(s): BIA 5-1058; Placebo Oral Tablet; Moxifloxacin 400 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will receive BIA 5-1058 tablets (containing 100 mg) as single, oral doses 30 minutes after the start of a moderate mealas follows:
400 mg BIA 5 1058, as 4 × 100 mg tablets and 8 placebo tablets
1200 mg BIA 5 1058, as 12 × 100 mg tablets; Matching placebo tablets administered as follows:
- placebo, as 12 × 0-mg tablets; Administered as follows:
- 400 mg moxifloxacin, as 1 × 400-mg tablet
Other intervention name(s): Zamicastat
Intervention MeSH terms: Moxifloxacin; Zamicastat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: BIA 5-1058; Pulmonary arterial hypertension; Heart failure; Cardiovascular Disease
A Phase I/IIa, Randomized, Double-Blind Study of the Safety and Efficacy of SPN-812 in Adults With ADHD
Condition: ADHD
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This will be a randomized, double-blind, placebo-controlled, parallel group, safety and
      tolerability study in adults with ADHD. The target subjects are healthy male or female adults
      aged 18 to 64 years, inclusive, with a diagnosis of ADHD. A total of fifty subjects will be
      enrolled at approximately 5 sites in the US. Subjects will be randomized (1:1) to one of two
      treatment groups, SPN-812V or placebo.
    


Intervention name(s): SPN-812; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Viloxazine, oral, 300mg, tid, 6 weeks; Placebo, oral, tid, 6 weeks
Other intervention name(s): viloxazine
Intervention MeSH terms: Viloxazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Healthy Planet Hepatitis B
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional

Summary: 
      This quality improvement project utilizes Epic Health Planet to increase screening for
      chronic hepatitis B through the creation of registries and ordering of hepatitis B laboratory
      panels.
    


Intervention name(s): Hepatitis B surface antigen, Hepatitis B core antibody, and Hepatitis B surface antibody
Intervention type(s): Other
Intervention description(s): The hepatitis B tests are released into the electronic medical charts of at-risk patients who have never been screened for chronic hepatitis B using population health tools.
Intervention MeSH terms: Antibodies; Immunoglobulins
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Oxygen Therapy for Headache
Condition: Primary Headache Disorder
MeSH terms: Headache Disorders; Headache Disorders, Primary; Headache
Study type: Observational

Summary: 
      Headache is one of the common causes of emergency department admissions and constitutes
      approximately 2%. Although the exact mechanism is not clear, It is known that high-flow
      oxygen therapy is effective in headache treatment. There are limited studies related to the
      use of oxygen therapy in headaches and its derivatives in the literature. In this study, the
      investigators aimed to compare the high and medium flow oxygen therapies with placebo in
      primary headache disorders.
    

Detailed description: 
      Four different treatment methods were determined; 1) high-flow oxygen (15lt/min oxygen), 2)
      medium-flow oxygen (8lt/min oxygen), 3) high-flow room air as placebo (15 lt/min room air),
      4) medium-flow room air as placebo (8 lt/min room air). All four treatment methods will be
      applied to all patients included in the study. One of the four treatments will be randomly
      applied at each separate ED admission with a gap of 1 week or more in between. This
      randomization will be performed by a computer at the time of admission. A study nurse will
      administer the patient's therapy according to the computer's current decision for 15 minutes.
      Patients and treating physicians will be blinded to the selected therapy. After 15 minutes of
      the end of treatment (at the 30th minute of the start of treatment), the treating physician
      will ask patients if they need rescue analgesia and analgesia will be administered if
      necessary. Additional analgesia is at the discretion of the treating physician. Patient data,
      including demographics, medical history, and findings of a physical examination performed
      before and after therapy will be recorded by the treating physician.
    

Intervention name(s): Oxygen therapy
Intervention type(s): Other
Intervention description(s): Oxygen therapy will be given for 15 minutes with a non-rebreathing mask.
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        all patients had one to six headache attacks per month which were started before 50 years
        old and were present for more than one year.
      
Keywords: oxygen therapy; migraine; emergency department; cluster type headache
Pain and Stress Assessment in Children
Condition: Acute Respiratory Infections
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Early Phase 1

Summary: 
      There may be pain and / or stress with vibrocompression. There may be pain and / or stress
      with the aspiration of secretions.
    

Detailed description: 
      Randomization to 10 children and 10 vibrocompression for aspiration of secretion.

      Fill in the evaluation form. Monitoring Heart Rate and Peripheral O2 Saturation (rest, during
      and after the technique performed).

      Photographic Record (rest, during and after the technique performed). Saliva Collection
      (rest, 5, 20 and 40 minutes after running technics). Data analysis.
    

Intervention name(s): Vibrocompression and aspiration of secretions
Intervention type(s): Other
Intervention description(s): The 20 children, study participants will be randomly assigned to different groups, where 10 children will be evaluated during vibrocompression maneuver, and another 10 will be assessed on the aspiration procedure. Randomization will be performed using an opaque envelope for specifying which group selection technique is evaluated.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Pain; Stress; Physiotherapy; Children
Trial of an RNActive®-Derived Cancer Vaccine in Stage IIIB/IV Non Small Cell Lung Cancer (NSCLC)
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a phase I/IIa open, uncontrolled, international, prospective clinical trial, in an
      out-patient setting, in patients with stage IIIB/IV NSCLC.

      The phase I part of the study consists of a dose escalation phase, in which the recommended
      dose (RD) for the phase IIa part of the study will be established based on the incidence of
      dose-limiting toxicities (DLT). In the phase IIa part of the study, additional patients will
      be included at the RD, to confirm the safety and explore the activity of that dose.

      This study will take place in Switzerland (2 sites) and Germany (11 sites).
    

Detailed description: 
      Medical Need:

      Lung cancer is the leading cause of cancer mortality in developed countries; about 87% of
      lung cancers are of the NSCLC type. Patients with more advanced but non-metastatic disease
      (IIIA or IIIB) usually undergo chemotherapy and/or radiation therapy, with or without
      secondary surgical resection. Patients with progression after chemotherapy and/or
      radiotherapy may receive second-line treatment with targeted therapies. Despite these
      aggressive treatments, only about 5% of patients with metastatic disease survive for 5 or
      more years. Given these dismal statistics, it is clear that new therapeutic approaches for
      treatment of NSCLC are urgently needed.

      Potential Benefits:

      CV9201 is an mRNA-based vaccine for the treatment of human NSCLC that is based on CureVac's
      RNActive® technology.

      As an mRNA-based vaccine, CV9201 features several advantages over other approaches: it is
      highly specific, there is no restriction to the patient's MHC genotype, and it does not need
      to cross the nuclear membrane to be active. Finally, in the absence of reverse transcriptase,
      RNA can not be integrated into the genome.

      For the planned first-in-man study, CV9201 will be administered in 5 doses. The phase I part
      of this phase I/IIa study is a dose finding study, to determine the RD for the phase IIa
      part.
    

Intervention name(s): CV9201
Intervention type(s): Biological
Intervention description(s): CV9201 is a vaccine consisting of five drug product components. Treatment will be administered on 5 timepoints.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Copenhagen Obesity Risk Assessment Study
Condition: Metabolic Syndrome; Abdominal Obesity; Heart Disease; Type 2 Diabetes
MeSH terms: Heart Diseases; Obesity; Diabetes Mellitus, Type 2; Metabolic Syndrome; Obesity, Abdominal
Study type: Interventional

Summary: 
      The aim of the present study is to assess the effect of a high intake of industrially
      produced trans fatty acids for 16 weeks on abdominal obesity and risk markers of type 2
      diabetes and heart disease in healthy, moderately overweight, postmenopausal women.
    


Intervention name(s): Trans fat (soy bean oil); Control fat (sunflower oil)
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Industrially produced trans fatty acid from soy bean oil (15 g/d for 16 weeks). The fat (a total of 25 g/d) will be baked into buns.; Control fat from sunflower oil, with 60% oleic acid (in total 25 g/d for 16 weeks). The fat will be baked into buns.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Trans fat; Obesity; Insulin sensitivity
Effects of Acute Exercise on Acetylcarnitine Concentration in Endurance Trained and Untrained Subjects
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      It has been suggested that imbalance between TCA-cycle flux and β-oxidation may underlie
      insulin resistance, a predisposing factor for the development of type 2 diabetes mellitus.
      Acetylcarnitine concentration is suggested to be a marker of such imbalance. It is expected
      that when TCA-cycle capacity is high (a high oxidative capacity), less acetylcarnitine will
      accumulate, because of an improved balance between supply and demand of lipids.

      The major research objective is to examine if acute exercise results in a more pronounced
      increase in acetylcarnitine concentration in sedentary subjects compared to endurance-trained
      subjects and if the exercise-induced increase in acetylcarnitine is restored more quickly in
      endurance-trained subjects when compared to sedentary subjects.

      The investigators hypothesize that the increase in acetylcarnitine levels will be lower in
      trained subjects when compared to sedentary subjects, due to a better balance between lipid
      supply and utilization by the TCA-cycle. Furthermore it is expected that acetylcarnitine
      concentrations will be restored faster in these trained subjects, because of a tighter
      regulation of influx of fatty acids.

      To test this hypothesis the investigators want to compare the acetylcarnitine response to
      exercise in a group of sedentary subjects and a group of endurance trained subjects. This
      response will be measured for 30 minutes after exercise with the use of 1H-MRS.
    


Intervention name(s): Cycling
Intervention type(s): Other
Intervention description(s): 30 minutes of cycling at 50% of predetermined maximal performance
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Kinematic Parameters to Predict Knee Diseases.
Condition: Knee Injuries; Knee Arthritis
MeSH terms: Arthritis; Knee Injuries
Study type: Observational

Summary: 
      There is no study to explore the prediction of knee diseases using kinematic parameters of
      knee during gait. The aim of this study is to explore the possibility of predicting knee
      diseases by gait parameters.
    


Intervention name(s): Observational gait analysis procedure
Intervention type(s): Procedure
Intervention description(s): All the participants underwent a standard observational procedure: i) diagnosed with knee injuries/arthritis; ii) For KOA, take radiographic examination (x-ray) and take gait analysis on a treadmill in barefoot; iii) For knee injuries, take gait analysis before surgery, the disease of patients was confirmed by surgery (knee arthroscopy); iv)Normal people take an physical examination to avoid other disease;
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All the patients were from January 2013 to March 2017.
      
Keywords: Knee; Gait; Injuries; Arthritis
Dose Escalation and Cohort Expansion Study of YS-ON-001 in Patients With Advanced Solid Tumors
Condition: Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 study evaluating the safety and tolerability of YS-ON-001 in patients with advanced
      solid tumors who have limited available treatment options, and exploratory evaluation of the
      pharmacological effect and efficacy of YS-ON-001. The study will be conducted in two parts:
      dose escalation and cohort expansion
    

Detailed description: 
      This is an open-label, Phase 1 study of YS-ON-001 vaccine administered intramuscularly (IM)
      as a single agent to patients with advanced solid tumors. Patients are eligible if they are
      refractory, resistant or intolerant to prior therapies.The study will assess YS-ON-001
      administered as a single agent, three times per week for 21-days with 1 week wash out period
      (28 days as 1 cycle) for 12 cycles in a continuous regimen. A dose escalation design will be
      applied in cohorts of 3-6 patients in Part I of the study.

      The starting dose will be 2ml (3 times/ week). Once the recommended phase II dose (RP2D) is
      established, the cohort will be expanded with at least 10 additional patients to further
      characterize the safety and tolerability at RP2D with specific tumour types, Breast cancer
      and Liver Cancer

      Treatment with YS-ON-001 may be continued for up to 12 cycles or until disease progression or
      if patient is withdrawn or unacceptable toxicity occurs. Patients who complete 12 cycles of
      treatment will be considered to have completed the trial. Patients who continue to benefit
      from treatment after 12 cycles may have the option to continue treatment upon agreement
      between the investigator and sponsor, and pending study drug availability.
    

Intervention name(s): YS-0N-001
Intervention type(s): Biological
Intervention description(s): Cancer vaccine
Other intervention name(s): Polyinosinic-polycytidylic acid/inactivated rabies virus
Intervention MeSH terms: Poly I-C
Intervention model: Single Group Assignment
Intervention model description: YS-ON-001 is a single agent used for this study
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Metal and Plastic Stents for Preoperative Biliary Decompression
Condition: Obstructive Jaundice; Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms; Jaundice; Jaundice, Obstructive
Study type: Interventional

Summary: 
      Covered self expandable metal stents (CSEMS) are three times larger in diameter than 10 Fr
      plastic stents. When compared to plastic stents, randomized trials have shown longer patency
      and fewer stent-related complications for CSEMS. The investigators hypothesize that placement
      of CSEMS would be a better treatment option for preoperative biliary decompression in
      patients with pancreatic cancer.
    

Detailed description: 
      Covered self expandable metal stents (CSEMS) are three times larger in diameter than 10 Fr
      plastic stents. When compared to plastic stents, randomized trials have shown longer patency
      and fewer stent-related complications for CSEMS. The investigators hypothesize that placement
      of CSEMS would be a better treatment option for preoperative biliary decompression in
      patients with pancreatic cancer as there will be better drainage of the obstructed biliary
      system with fewer adverse events.
    

Intervention name(s): Metal stent; Plastic stent
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a metal stent.; Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a 10Fr plastic stent.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pancreatic cancer; obstructive jaundice; Obstructive jaundice secondary to pancreatic cancer
Home-based Computerized Cognitive Rehabilitation in Chronic Stage Stroke
Condition: Chronic Stroke; Cognitive Impairment
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This study evaluates the effectiveness of Guttmann NeuroPersonalTrainer (GNPT), a
      tele-rehabilitation platform developed as a tool for the cognitive rehabilitation of chronic
      stroke patients. All patients will receive this treatment but in different order: half will
      receive GNPT and the other half will receive sham cognitive training; after a washout period
      of three months, crossover will occur and participants from the GNPT condition will receive
      sham cognitive training, while participants originally from the control intervention will
      receive GNPT.
    


Intervention name(s): Guttmann, NeuroPersonalTrainer; Ictus.online
Intervention type(s): Other; Other
Intervention description(s): Guttmann NeuroPersonalTrainer (GNPT) is a telerehabilitation platform. GNPT consists of a set of computerized cognitive exercises covering different cognitive functions and subfunctions. Every task has been specifically based on cognitive paradigms to address specific cognitive subfunction. The rehabilitation process starts by assigning a patient to a therapist responsible for the treatment. The therapist has then to perform the initial neuropsychological assessment, consisting of a set of validated tests used to attention, memory and executive functions prior to the treatment. The results of these tests will be stored in GNPT system. Then, the cognitive profile is calculated using these results, and taking into account the patient's age and study level. Using this profile, the program assigns a set of computerized tasks to a certain day, configuring the input parameters of each task in order to personalize treatments.; An online domain which provides a daily session of one hour of duration. Each session consists of four ten-minute videos. After each video, the participant must complete a three-question quiz about the contents of the video (for example, "What animal appears in in the video?"). The difficulty level is minimal, and does not vary depending on the execution of the participant.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: computerized cognitive rehabilitation
A Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Common Facial Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess safety and efficacy of a new foam formulation of
      tazarotene in subjects with acne vulgaris.
    

Detailed description: 
      A multicenter, randomized, double-blind, vehicle-controlled, parallel-group study comparing
      tazarotene foam with vehicle foam in subjects with acne vulgaris. Approximately 742 subjects
      will be enrolled and randomized to 1 of the 2 study product groups in a 1:1 ratio (tazarotene
      foam: vehicle foam). Subjects will apply tazarotene foam or vehicle foam to the entire face
      once daily for 12 weeks; study visits will occur at baseline (week 0/day 1) and at weeks 2,
      4, 8, and 12.
    

Intervention name(s): Tazarotene Foam; Vehicle Foam
Intervention type(s): Drug; Drug
Intervention description(s): Tazarotene foam once a day application to the face; Vehicle Foam once a day application to the face
Intervention MeSH terms: Tazarotene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acne