bioihbjkbjnl/mcl2 huggingface dataset:
PK, PD, Safety and Tolerability of Lipegfilgrastim in Healthy Japanese and Caucasian Participants
Condition: Pharmacokinetics; Pharmacodynamics
Study type: Interventional
Phase: Phase 1

Summary: 
      Cohorts of Japanese participants will be enrolled and treated prior to cohorts of Caucasian
      participants for the sake of matching. Every effort will be made to match Caucasian and
      Japanese participants on a cohort basis at enrollment. Reasonable effort will be made to
      maintain balance between male and female participants within the cohorts. There will be no
      replacement of participants following randomization.
    

Detailed description: 
      Eligible participants will be admitted to the investigational center and after confirming
      their eligibility will be randomized to receive a single dose of 30, 60, or 100 μg/kg
      lipegfilgrastim. There will be 11 visits to the investigational center during the study,
      including a screening visit, 1 inpatient period (through Day 4 post-dose) and 9 ambulatory
      visits.

      Blood samples for PK, PD and immunogenicity analysis will be collected pre-dose and at
      specified time points post-dose. A mandatory blood sample for pharmacogenetics (PGx) will be
      collected from all participants. During the study the following safety assessments will be
      performed: vital signs measurements,physical examinations, record of adverse events, clinical
      laboratory tests, urinalysis, safety ECG recordings, local tolerability (injection site
      reactions), overall tolerability, pregnancy testing, spleen sonography, and concomitant
      medications
    

Intervention name(s): lipegfilgrastim
Intervention type(s): Drug
Intervention description(s): lipegfilgrastim 30 μg/kg, 60 μg/kg, 100 μg/kg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Lipegfilgrastim, Lonquex, Japanese Bridging
Acupuncture in Patients With Stable Angina Pectoris
Condition: Angina, Stable
MeSH terms: Angina Pectoris; Angina, Stable
Study type: Interventional

Summary: 
      This trail aims to evaluate the efficacy of acupoints on the specific meridian for chronic
      stable angina pectoris, compared with acupoints on the other meridian, sham acupoints and
      waiting-list. And to confirm the specificity of acupoints on meridian.
    

Detailed description: 
      The basis of acupuncture is the theory of meridians and acupoints. Meridian and collaterals
      internally pertain to viscera, and externally spread over the extremities. An acupoint is the
      place where the visceral qi and meridian qi distributed in. besides acupoints are the
      stimulus points and reactive points for acupuncture to treat the diseases. Selecting the
      acupoints on the specific meridian is the basic principle of acupuncture. Recently, as to the
      existence of specificity of acupoints on the meridian has been questioned by many
      researchers. This trial using chronic stable angina pectoris as a carrier, select the
      acupoints on the hand shao yin heart meridian and hand jue yin pericardium meridian to treat
      chronic stable angina pectoris. Compared with acupoints on the other meridian and
      non-acupoints ,aiming to evaluate the efficacy, furthermore ,to confirm the existence of the
      specificity of acupoints on meridian.
    

Intervention name(s): acupuncture; Basic treatment
Intervention type(s): Other; Drug
Intervention description(s): In each session, we treat bilaterally, 3 times a week and 2 days off a week, each patient in the acupuncture treatment groups will receive 12 sessions of acupuncture treatment over 4 weeks. The whole study period is 20 weeks including 4-week baseline period,4-week treatment period, and 12-week follow-up period. we will investigate at 0 day,4week,8week,12week,16week after randomization。; Each group in the basic treatment，Foundation treatment including health education and basic drug therapy.
We recommend lifestyle modification for all patients. Modifications include increasing exercise; limiting alcohol consumption; and weight loss; quit smorking etc.
Basic medication： Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.
Other intervention name(s): Electro-acupuncture，Massage; health education ， basic drug therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: acupuncture; Angina; Stable Angina Pectoris
Effects of Chronic Intake of Processed Foods on Circulating Inflammatory Markers in Healthy Men
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      This study aims to investigate the effects of diets enriched or depleted in foods at high
      risk of containing pro-inflammatory bacterial molecules, on markers of inflammation and
      cardiometabolic risk in healthy men. The study design is an interventional diet study, with 7
      days dietary advice to avoid processed foods, followed by 4 days in which lunch and evening
      meal are provided to volunteers. Anthropometric and blood markers of cardiovascular disease
      risk are measured at the start and end of each dietary phase. The aim is to gain an improved
      understanding of how processed foods modify risk of cardiometabolic disease.
    

Detailed description: 
      This study aims to investigate the effects of diets enriched or depleted in foods at high
      risk of containing pro-inflammatory bacterial molecules, on markers of inflammation and
      cardiometabolic risk in healthy men. The study design is an interventional diet study, with 7
      days dietary advice to avoid processed foods, followed by 4 days in which lunch and evening
      meal are provided to volunteers. Anthropometric and blood markers of cardiovascular disease
      risk are measured at the start and end of each dietary phase. The aim is to gain an improved
      understanding of how processed foods modify risk of cardiometabolic disease.

      Three blood samples, each of 15 ml, will be taken on days 0, 8 and 12. Measurements at each
      timepoint include weight, waistline, serum low-density lipoprotein cholesterol, high density
      lipoprotein cholesterol, triglycerides, insulin, leptin, C-reactive protein and endotoxin.

      Volunteers will be requested to avoid processed foods, ready-prepared meals, foods containing
      minced meats, foods containing ready-chopped vegetables, cheese or chocolate for the first 7
      days of the study.

      For days 8 to 11, volunteers will be provided with meals, purchased from local supermarkets,
      which from previous tested were found to contain high levels of bacterial pro-inflammatory
      molecules (PAMPs).

      Diet diaries collected during the study will be combined with diet recall information to
      investigate habitual and on-study frequency of consumption of specific food groups.
    

Intervention name(s): Low PAMP diet
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Immunologic Response to Influenza Vaccination in Children and Adolescents
Condition: Influenza, Human; Immune Response
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate immunologic response to different types of influenza
      vaccine among children/adolescents/young adults 4-20 years of age. This is a randomized
      controlled trial (RCT), that will assess immune response in 120 participants (60 per vaccine
      arm) pre- and post-vaccination to Flucelvax (egg-free inactivated flu shot) and Fluzone
      (egg-based inactivated flu shot).
    

Detailed description: 
      This is a non-blinded, randomized controlled trial analyzing influenza vaccine immunogenicity
      response in children/adolescents/young adults aged 4-20 years given one of two FDA approved
      and licensed influenza vaccines: Flucelvax (egg-free inactivated flu shot) and Fluzone
      (egg-based inactivated flu shot). This study will enroll 120 healthy participants, 60 per
      vaccine arm. Participants will be randomized using a 1:1 allocation to receive either
      Flucelvax or Fluzone. Blood work will be conducted on all participants at baseline prior to
      vaccine receipt and post-vaccination at Day 7 (range 6-9 days) and Day 21 (range 21-35 days).
      The primary objective of the study is to determine pre and post serologic,responses to each
      vaccine type.
    

Intervention name(s): Flucelvax inactivated influenza vaccine; Fluzone inactivated influenza vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Participants randomized to this study influenza vaccine arm will receive Flucelvax inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.); Participants randomized to this study influenza vaccine arm will receive Fluzone inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1:1 RCT allocation to one of two influenza vaccines: Flucelvax or Fluzone.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: inactivated; influenza; vaccine
Backpack Carrying in Children With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      Cystic Fibrosis is a hereditary, chronic respiratory illness. Cystic Fibrosis leads to a
      progressive decline in lung function.

      School-aged children with cystic fibrosis experience backpack carrying everyday. Backpack
      carrying induce a restrictive effect responsible for lower lung function. Respiratory muscle
      strength is also impaired.

      No studies assessed aerobic capacities during children's gait while carrying a backpack.

      The investigators hypothesized that backpack carrying will induce an acute decline in lung
      function in children with cystic fibrosis compared to healthy children. Investigators also
      hypothesized that aerobic capacities will be impaired.
    


Intervention name(s): Backpack Carrying
Intervention type(s): Behavioral
Intervention description(s): A 12,5% of body weight backpack will be used for each measurement. Lung function will be assessed while carrying a double strap backpack, a mono shoulder backpack and without a backpack.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Cystic fibrosis; Backpack carrying; Respiratory function; Children
Study of Safety & Tolerability of OPC-34712 as Adjunctive Therapy in Treatment of Adult Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the long-term safety, tolerability and efficacy of
      oral OPC-34712 as adjunctive therapy in the treatment of adult patients with Major Depressive
      Disorder (MDD).
    


Intervention name(s): ADT; OPC-34712
Intervention type(s): Drug; Drug
Intervention description(s): Once daily dosing during the duration of the study.; OPC-34712, Oral Tablets, 0.25 - 3 mg
Other intervention name(s): Anti-depressant Drug Therapy
Intervention MeSH terms: Antidepressive Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of LY3361237 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to determine:

        -  The safety of LY3361237 and any side effects that might be associated with it.

        -  How much LY3361237 gets into the blood stream and how long it takes the body to remove
           it in healthy participants.

      Participants will be admitted to the clinical research unit (CRU) for 4 overnight stays. The
      study will last about 12 weeks for each participant, not including screening.
    


Intervention name(s): LY3361237 - SC; LY3361237 - IV; Placebo - SC; Placebo - IV
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): LY3361237 administered SC; LY3361237 administered IV; Placebo administered SC; Placebo administered IV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Validation and Refinement of Noninvasive Diagnostic Biomarkers for Endometriosis, The ENDOmarker Protocol
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Observational [Patient Registry]

Summary: 
      This study involves the prospective collection of endometrial biopsy tissue, serum, plasma,
      whole blood for DNA extraction, and urine from women who will be diagnosed as having (or not
      having) endometriosis at the time of scheduled surgery. The investigators plan to enroll
      approximately 500 women to validate and optimize the use of genomic classifiers alone or in
      combination with serum markers (such as cytokines) as a non-surgical marker of disease.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Females aged 18-44 who are scheduled to undergo gynecologic surgery
        (laparoscopy/laparotomy). Indications for surgery can include: infertility, endometriosis,
        tubal ligation, lysis of adhesions, pelvic pain, hysterectomy (for benign condition),
        myomectomy, salpingo-oophorectomy, cystectomy, or diagnostic laparoscopy.
      
Biospecimen description: 
      Collection of endometrial biopsy tissue, serum, plasma, whole blood for DNA extraction and
      urine
Home-based Respiratory Physiotherapy and Telephone-Based Psychological Support in Severe COVID-19 Patients
Condition: Covid19; Respiratory Disease; Mental Health Disorder
MeSH terms: COVID-19; Respiratory Tract Diseases; Respiration Disorders; Mental Disorders
Study type: Interventional

Summary: 
      Some COVID-19 survivors may have respiratory and mental health sequelae, especially those who
      required hospitalization. The investigators hypothesize that the participation of a
      rehabilitation program composite by home-based respiratory physiotherapy and telephone-based
      psychological support will improve respiratory function, quality of life, and psychological
      status in severe COVID-19 patients.
    

Detailed description: 
      In Peru, almost one million persons have survived COVID-19 and initial reports indicate that
      could exist long-term health damage. This study aims to assess the efficacy of a 6-week
      rehabilitation program following hospital discharge for patients who had severe COVID-19. The
      program includes 12 sessions of home-based respiratory therapy that the patient will carry
      out with a physiotherapist and 7 sessions of telephone-based psychological support bring by a
      psychologist.
    

Intervention name(s): Respiratory and psychological rehabilitation
Intervention type(s): Other
Intervention description(s): Respiratory rehabilitation consists of 12 sessions of respiratory and physical exercises that patients perform at home with the help of a physiotherapist. Sessions have 1 hour of duration and are performing twice a week. Exercises include (1) Training of the respiratory muscles through pursed-lip breaths. (2) Effective cough exercises. (3) Diaphragmatic contractions in a supine position with a lightweight placed on the anterior abdominal wall. (4) Stretching exercise of extremities and the back.
The psychological support consists of 1 session to make the psychological history of the participant, and 6 sessions of emotion-centered problem-solving therapy, with cognitive-behavioral components and psychological management of emergencies and crises. These sessions have a 1-hour duration and are telephone-provided once a week by psychologists following the guidelines of the Inter-Agency Standing Committee on Mental Health and Psychosocial Support in Humanitarian and Disaster Emergencies.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COVID-19; Mental Health; Respiratory Function Tests; Physical and Rehabilitation Medicine; Quality of Life
Manipulating Tobacco Constituents in Female Menthol Smokers
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      This study examines the potential effect of reducing nicotine content or menthol or both in
      women of reproductive age, a vulnerable population identified by the FDA in need of further
      research.
    

Detailed description: 
      Study is designed to address the following questions that have been outlined by the FDA as
      particular areas of interest:

        1. What are the factors, including menthol and other flavorings that influence the appeal
           of tobacco products to vulnerable populations: What is the impact of these factors on
           cessation, switching tobacco products and multiple use?

        2. What is the potential impact of modifying nicotine levels on dependence, and smoking
           rate and cessation, as well as patterns of switching products and use of multiple
           tobacco products?

        3. Beyond nicotine, what other constituents enhance addictive properties?
    

Intervention name(s): Reduced Nicotine Content- Non Menthol; Reduced Nicotine Content- Menthol; Conventional Nicotine Content- Menthol; Conventional Nicotine Content- Non Menthol
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Switch from own brand of cigarette to a research cigarette with a Reduced Nicotine Content of 0.07mg nicotine yield without menthol.; Switch from own brand of cigarette to Reduced nicotine level of each research cigarette to 0.07mg nicotine yield with Menthol; Allow own brand of Conventional Nicotine-Menthol Cigarette; Switch from own cigarette to a research cigarette which contains Conventional Nicotine yield.
Other intervention name(s): SPECTRUM Research Cigarette - NRC 200; SPECTRUM Research Cigarette - RNC 201; Own brand of Conventional Nicotine-Menthol Cigarette; SPECTRUM Research Cigarette - NRC 600
Intervention MeSH terms: Menthol; Nicotine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: menthol; nicotine
Testing A Visual Thermometer in Newborns and Young Infants
Condition: Hyperthermia; Hypothermia
MeSH terms: Hypothermia; Hyperthermia; Fever
Study type: Observational

Summary: 
      "Severe neonatal jaundice and acute bilirubin encephalopathy are a major cause of death and
      disability among newborns in LMICs. Filtered sunlight phototherapy (FSPT) was developed,
      tested and shown to be safe and efficacious in the treatment of jaundice, because effective
      electric-powered conventional phototherapy is often unavailable10,11. However, FSPT currently
      requires at least hourly temperature monitoring by healthcare providers (HCPs) because
      infants receiving FSPT are prone to both hypothermia and hyperthermia.

      20 years ago, a liquid crystal thermometer, ThermospotTM (Maternova, Providence, RI) was
      developed primarily for use in LMICs. It was designed to detect hypothermia and is most
      sensitive in cold infants and not as sensitive as needed for detecting hyperthermia or fever.
      The purpose of this pilot study is to determine the accuracy and useability of this LCTD for
      a wider spectrum of temperatures when used in a large group of infants in a high-income
      country. If the device performs well in this study, we plan to study it in a low- and
      middle-income country in Africa."
    


Intervention name(s): observational
Intervention type(s): Device
Intervention description(s): Infants will get their temperature measured with the liquid crystal thermometer. We are not providing any interventions as they will be in the care of a healthcare team.
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infants between the age of 0-6months
      
Keywords: temperature monitoring; liquid crystal thermometer; hypothermia; hyperthermia; LCTD; infant temperature; infant hyperthermia; infant hypothermia; neonate hyperthermia; neonate hypothermia; neonate temperature
Task Oriented Training in Post Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This study will be observe the effect of Task-oriented training on the dexterous movements of
      hands in hemiparetic post-stroke patients. Patient will be recruited that meet the inclusion
      criteria, with unilateral hemiplegia referred by Neurophysician having stroke for the first
      time, between age 47-70 year, both males and females, score of spasticity for upper extremity
      (shoulder, elbow) below and equal 2 based on the Modified Ashworth Scale (MAS), ability to
      comprehend simple instructions (Mini-Mental State Examination with a minimum score > 24),
      Brunnstrom stages ≥ 4, not submitted to other upper-limb rehabilitation programs during the
      participation in this study. The individuals with recurrent stroke episodes and transient
      ischemic attack, other neurological diseases (Parkinson's disease, multiple sclerosis,),
      hemineglect, no sitting balance and comorbidities are excluded. Outcome measures used are
      FuglMeyer assessment scale (wrist and hand) and Wolf motor function test for upper extremity
      while Barthel index to assess the activities of daily living. All procedures will perform by
      taking informed consent. All Ethical standards for both patient and institution will be
      followed. After collecting data, will apply Shapiro Wilk test to check the normal
      distribution of data. For analysis use SPSS version 25
    


Intervention name(s): Conventional physical therapy; Task Oriented Training
Intervention type(s): Other; Other
Intervention description(s): Targeted muscle stretching and Strengthening (flexors, Extensors, abductors, internal and external rotators, of Shoulder, Elbow, forearm (supination & pronation) and hand 10 repetitions×1 set, 4 days/ week. Transcutaneous Electrical nerve Stimulation for 10-20 min, 4 days/ week. Total of 16 sessions were given each consisting of 45 mins.; Experimental group was given Task oriented protocol including activities such as Table-top polishing, Arm cradling, Reach forward and pick-up or touch an object, Reached sideway to pick-up an object and transferring it to a table in front, Pouring
½ cup of water from a measuring pot into wide mouth glass held in opposite hand, Picking up pen from thumb and first two fingers, lifting a basket and placing it on the table 10 repetitions×1 set for each activity, 4-5days/week. Total of 16 sessions were given each consisting of 45 mins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stroke; Task; Training; Movement