bioihbjkbjnl/mcl2 huggingface dataset:
Evaluate the Efficacy and Safety of 'Immuncell-LC' in Patients Undergoing Liver Transplantation
Condition: Liver Transplantation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to investigate and validate the maximum tolerated dose (MTD) or
      maximum available dose (MFD), safety and efficacy on patients with hepatocellular carcinoma
      beyond Milan criteria who undergo liver transplantation.
    

Detailed description: 
      ILC-IIT-07 is open-label, phase 1/2 clinical trial to confirm safety on patients with
      hepatocellular carcinoma beyond Milan criteria who undergo liver transplantation. For primary
      outcome, maximum feasible dose (MFD) or maximum tolerated dose (MTD) will be evaluated.

      For secondary outcome, Time to Recurrence(TTR), Recurrence-Free Survival(RFS), Overall
      Survival(OS) will be evaluated.
    

Intervention name(s): Immuncell-LC
Intervention type(s): Biological
Intervention description(s): Activated T lymphocyte
Intervention model: Single Group Assignment
Intervention model description: Liver cancer patients undergoing liver transplantation with hepatocellular carcinoma exceeding the Milan criteria
Masking: None (Open Label)
Primary purpose: Treatment
Cannabis Use in Cancer Patients
Condition: Solid Tumor, Adult
MeSH terms: Marijuana Abuse
Study type: Observational

Summary: 
      The goal of this study is to determine the feasibility of a human observational study of
      orally administered cannabis use among cancer patients.
    

Detailed description: 
      Tightly controlled experimental laboratory studies (e.g., clinical trials with randomization)
      using Cannabis products available in state-regulated markets are simply, at this point, not
      possible owing largely to federal law and the University requirements related to the
      Controlled Substances Act and Drug Free Schools and Communities Act. Because a traditional
      clinical trial design is not possible given the current federal status of Cannabis products,
      this investigator will use a patient-oriented, prospective observational design.
      Specifically, individuals who have already decided to try Cannabis for their cancer
      treatment-related symptoms will initiate use of an orally administered product they have
      selected. A research assistant will provide information on the range of edible cannabis
      products and basic information about their various cannabinoid profiles, approximate prices,
      and nearby locations where participants may choose to purchase their product. The
      participants will then purchase the product and decide how often and how much to use. This
      approach is consistent with federal law and supported by our preliminary and ongoing
      studies(1R01AT009541-01, 1R01DA044131-01, CDPHE2902, R01DA039707). Patients will take the
      product as they see fit, without any frequency or dosing instructions from study staff, for
      two weeks, at which time they will be scheduled for an acute administration session (Ta1-Tc1)
      so that we may examine the acute effects of the product. The final follow-up will be one
      month later via an online survey sent directly to the participant via email.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Male or females, ages 21 and up, with a diagnosis of any solid tumor type who has or is
        undergoing either curative or palliative treatment
      
Biospecimen description: 
      Whole blood sample
    
Keywords: Cannabis; Tumors; Observational Study
Remifentanil Versus Morphine for Sedation of Premature Neonates With Respiratory Distress Syndrome
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Premature Birth; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      In this randomised controlled study we intended to compared intubation conditions and the
      continuous infusion of remifentanil (n=10) and morphine (n=10) in mechanically ventilated
      premature neonates (28-34wk) regarding the time to be awake and, the time until extubation
      after interruption of the opioid administration.
    

Detailed description: 
      Intubation and mechanical ventilation are majors component of intensive care for premature
      neonates with respiratory distress syndrome (RDS) and is associated with physiologic,
      biochemical, and clinical responses indicating pain and stress in prematures. Although
      morphine is one of the most used drugs for premedication and for sedation and analgesia
      during mechanical ventilation in the treatment of RDS its pharmacological profile precludes
      several limitations mostly due to its much delayed onset of action what makes the drug not
      suitable as premedication and due to its prolonged duration of action mainly in prematures.
      Unlike morphine, remifentanil has an unique pharmacokinetic properties with a rapid onset of
      action and, a fast decrease in plasma concentration after interruption of administration due
      to a context-sensitive half-time of 3.2 minutes. So, it could be the ideal opioid for
      neonates who are especially sensitive to respiratory depression by opioids
    

Intervention name(s): Remifentanil
Intervention type(s): Drug
Intervention MeSH terms: Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Supportive Care
Keywords: intubation; Sedation; Analgesia; preterm neonate; remifentanil; morphine; respiratory distress syndrome
Manually Assisted Cough Technique and Incomplete Cervical Spine Injury
Condition: Spinal Cord Injuries
MeSH terms: Cough; Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      To determine the effectiveness of manually assisted cough technique on peak cough flow and
      pulmonary functions in patients with incomplete cervical spine injury. Previous studies were
      designed to target only a small sample. Level and American Spinal Cord Injury Association
      (ASIA) scale were not specified so this study covers this aspect.
    

Detailed description: 
      The previous studies show that the partial control of the muscle necessary for cough, which
      varies with motor level, proportionately improves the patient's ability to cough
      volitionally. Spinal cord injury also affects mucus clearance, the peak flow meter was used
      to assist the ability of cough and they also measure the peak cough flow (PFC).In the
      literature for the airway clearance, the following techniques were used, incentive
      spirometer, balloon, and blowing exercise, manually assisted cough technique active cycle of
      breathing exercise, postural drainage, autogenic drainage, positive expiratory pressure.
      There is increasing interest in strategies such as interval training that may provide a
      tolerable training load while maintaining an effective stimulus for adaptation. Manually
      assisted cough technique is used to enhance the cough strength, to help with mucus secretion
      it can be carried out in lying, side-lying, or sitting positions.it is important that clear
      secretion in order to maintain clear and healthy lungs, the risk of repeated chest infection
      and complication can be reduced which improve the quality of life. Manually assisted cough is
      a technique using strong arms to assist cough. This may be providing help in neuromuscular
      disease or spinal cord injury with weak respiratory and abdominal muscle.
    

Intervention name(s): Manually assisted cough technique
Intervention type(s): Other
Intervention description(s): Manually assisted cough technique will be given for four weeks. 10 to 12 repetitions of manually assisted cough technique with rest will be given in one minute 3 to 4 time of repetition in a 1 set. The result of the peak cough flow meter and incentive spirometer will be check pre and post only.3 sets will be given in one session and 2-time session will be recommended per day. The session will be given three days in a week. The Result of the Peak Cough flow meter and incentive spirometer will be check pre and post only.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Manually assisted cough technique; Peak cough flow; Pulmonary function; Spinal cord injury
Pictorial Warning Labels and Memory for Cigarette Health-risk Information Over Time
Condition: Smoking Cessation; Smoking, Cigarette
Study type: Interventional
Phase: Phase 3

Summary: 
      Pictorial cigarette warning labels (PWLs) are thought to increase risk knowledge, but
      experimental research has not examined PWLs' longer term effects on memory for health risks.
      This trial tests memory for health risks immediately or after a six-week delay for
      US-representative adult smokers, US-representative teen smokers/vulnerable smokers, and
      Appalachian-representative adult smokers. In addition, the trial tests the effects of
      different warning label components and the consequences of memory for labels on risk
      perceptions and quit intentions.
    


Intervention name(s): Text-only PWL; Low-emot PWL; High-emot PWL; Immediate posttest; delay posttest
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Control condition; Pictorial warning; Pictorial warning
Allocation: Randomized
Intervention model: Factorial Assignment
Primary purpose: Prevention
Keywords: pictorial warning labels; risk knowledge; emotion; memory; risk perceptions; quit intentions
Metabolic Phenotyping of Individuals Born Following Assisted Reproduction Techniques
Condition: Metabolic Syndrome; Diabetes
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      This study is to compare the effects of high fat overfeeding on metabolic risk factors in
      children born though assisted reproduction technologies (ART) versus children conceived
      naturally (controls). The investigators will utilize state of the ART measures to
      characterize the physiological, endocrine and molecular responses to high fat overfeeding.

      The investigators hypothesize that children conceived following ART will have greater
      responses to high fat dietary challenge and that this will be associated with DNA
      hypermethylation of genes that are involved in lipid metabolism.
    

Detailed description: 
      This study represents a novel initiative by the investigators to determine whether children
      conceived through ART have different metabolic responses at baseline or in response to high
      fat overfeeding as compared to age and body mass index-matched spontaneously conceived
      controls. Furthermore, the investigators will identify any differences in DNA methylation of
      candidate genes involved in lipid metabolism in adipose tissue and blood, to determine
      whether this is related to adverse outcomes during high fat overfeeding. The results from
      this study will help answer growing questions of the future health of In vitro fertilisation
      (IVF) babies, and may stimulate further research into optimising protocols for ovarian
      stimulation or in-vitro conditions during early blastocyst development.
    

Intervention name(s): high fat overfeeding
Intervention type(s): Dietary Supplement
Intervention description(s): Dietary Supplement:3 days overfeeding
Other intervention name(s): 3 days overfeeding
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: assisted reproduction technology; Metabolic risk factors; In Vitro Fertilisation
Drug Abuse Prevention Among Girls Through a Mother-Daughter Intervention
Condition: Substance Use
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to determine a computer- and family-based drug abuse prevention
      program is able to reduce drug use among early adolescent girls.
    

Detailed description: 
      This study longitudinally tested a computerized, parent-involvement substance abuse
      prevention program for adolescent girls and their mothers. The prevention program aimed to
      strengthen and sustain the mother-daughter bond while equipping girls with the necessary
      information and skills to increase protective factors and reduce risk factors associated with
      tobacco, alcohol, and other harmful substance use.
    

Intervention name(s): Prevention
Intervention type(s): Behavioral
Intervention description(s): 9-session computerized cognitive behavioral program that young girls and their mothers interact with on a weekly basis in the privacy of their home. Girls and their mothers will watch and interact with 10 compact disc (CD) intervention sessions to learn skills to help girls avoid substance use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: drugs; youth; parent; computer; prevention
Evaluation of Quality of Life in Patients With Type 1 Diabetes Mellitus During the Covid-19 Pandemic
Condition: Type 1 Diabetes Mellitus; Covid19
MeSH terms: COVID-19; Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      During the COVID-19 pandemic, the time spent at the home of patients has increased because of
      national quarantine policies and patients' fear of getting sick. For this reason, in this
      ongoing process, patients have been unable to go to work regularly due to their chronic
      diseases (being on administrative leave) and their fear of going out. These reasons have
      prevented being physically active. The aim of the study is to evaluate the physical activity
      level, quality of life, glucose control, anxiety, depression, fear of hypoglycemia and
      loneliness perceptions of patients with type 1 diabetes mellitus during the COVID-19 pandemic
      period and compared with healthy controls.
    


Intervention name(s): Online Survey
Intervention type(s): Other
Intervention description(s): Online surveys will be applied to all participants
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with type 1 diabetes mellitus and healthy controls between 18-65 years
The Clinical Effect of Adaptive Posture-balance Cardiac Rehabilitation Exercise on Cardiovascular Diseases
Condition: Cardiac Rehabilitation; Exercise Therapy; Balance Exercises; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The whole experiment included one-month APBCRE therapy and two assessments. The one-month
      APBCRE consisted of twelve exercise sessions, evenly three times per week. At baseline and
      after rehabilitation, participants underwent one assessment, including car-diopulmonary
      exercise testing (CPET), resting metabolic rate (RMR) detection, and quality of life
      questionnaire (QoL). The primary outcomes were exercise capacity measured by function
      parameters at anaerobic threshold (AT) and other CPET physiological indexes. The secondary
      endpoints were the RMR level and QoL score.
    


Intervention name(s): Adaptive posture-balance cardiac rehabilitation exercise
Intervention type(s): Behavioral
Intervention description(s): The process of APBCRE consisted of four parts: breathing training and warm-up, aerobic exercise, resistance exercise, and flexibility exercise. The first part lasted for 5-15 minutes, based on balance exercise. The specific steps of balance exercise included stretching of upper limbs, legs, waist, and other parts. And the second part was generally moderate-intensity endurance exercise, thresholding for 60%-75% VO2max/kg metabolic equivalents (METs), 60%-70% maximum heart rate, rating of perceived exertion (RPE) Borg grade 12-13. The exercise duration of this part was usually 30 min. During the self-created APBCRE, the resistance exercise was carried out with the help of the body-building vehicle, and its power was adjusted based on danger assessment level and oxygen uptake at anaerobic threshold. The last part usually lasted for 5-10 min for each-level participants. The total exercise time for one session was generally 50-70 min.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ALK33-001: A Study of RDC-0313 Administered to Healthy Adults
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the pharmacokinetics, safety, and tolerability of
      RDC-0313 following oral administration.
    

Detailed description: 
      This is a single-center, randomized, double-blind, ascending dose, placebo controlled study.
      Dosing sequences will consist of 5 administrations of an oral solution of either ascending
      doses of RDC-0313 or volume-match placebo. Dosing of cohorts will be staggered to allow a
      blinded safety review to occur prior to dosing the next cohort. Subjects will be admitted to
      the facility the morning before each dose, and will be required to fast overnight prior to
      study drug administration. They will be discharged from the facility after the 36-hour
      postdose assessments are completed.
    

Intervention name(s): RDC-0313; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral solution given in 5, 15, 25, 50, and 75 mg single doses; Volume matched placebo; oral solution; single dose
Intervention MeSH terms: ALKS-33
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alcohol dependence; Opioid antagonist; RDC-0313
Effects of Vaginal Lactoferrin Administration Prior to Genetic Amniocentesis on Inflammatory Mediators
Condition: Pregnancy
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to evaluate the effect of vaginal lactoferrin administration on
      amniotic fluid PGE2 level and MMP-TIMP system in women undergoing genetic amniocentesis. Two
      groups of patients will be prospectively enrolled: not treated with lactoferrin and treated
      with vaginal lactoferrin 4 hours prior to mid-trimester genetic amniocentesis.
    

Detailed description: 
      Pregnant women undergoing genetic amniocentesis within the 16th-18th gestational week will be
      enrolled at the Obstetric Unit, University of Ferrara.

      The selected patients will be randomly assigned to receive a vaginal compound containing 300
      mg of lactoferrin 4 hours before amniocentesis or they will be untreated (controls).

      Amniotic fluid samples will be obtained by transabdominal amniocentesis and the sample not
      required for clinical purposes will be centrifuged to remove particulate material and the
      supernatants will be aliquoted and stored at -80°C until assay.
    

Intervention name(s): Lactoferrin
Intervention type(s): Drug
Intervention MeSH terms: Lactoferrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Amniocentesis
The Effects of Valsalva Maneuver on Head, Neck and Upper Extremity Arterial Systems
Condition: Asymptomatic Diseases
MeSH terms: Asymptomatic Diseases
Study type: Observational

Summary: 
      The aim of this study is to determine the relation between arterial diameter and flow of
      carotis interna, brachial artery and radial artery before and after valsalva maneuver.
    

Detailed description: 
      The aim of this study is to determine the relation between arterial diameter and flow of
      carotis interna, brachial artery and radial artery before and after valsalva maneuver. A
      total of 70 patients in preoperative period will enroll in this study. After a deep
      inspiration, patients will asked to exhale to a valf system with a flow pressure of 20-40
      mmHg and duration of 15 seconds. During valsalva maneuver, the diameter and flow rates of
      carotis interna, brachial artery and radial artery will measure using ultrasound. All data
      will be recorded.
    

Intervention name(s): valsalva maneuver
Intervention type(s): Procedure
Intervention description(s): the effects of valsalva maneuver on arterial pressure
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        peroperative patients, healhty volunteers
      
Keywords: valsalva
Evaluation of Immunogenicity and Safety of VARIVAX™ New Seed Process (NSP) in Children (V210-063)
Condition: Varicella
MeSH terms: Chickenpox
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX™ (Varicella
      Virus Vaccine Live) manufactured with a New Seed Process (NSP) compared with the VARIVAX™
      2007 process. The primary hypotheses being tested are that antibody response rate and mean
      antibody titer induced at 6 weeks after a single vaccination by VARIVAX™ NSP are non-inferior
      to those induced by VARIVAX™ 2007 process, and that antibody response rate induced by
      VARIVAX™ NSP is acceptable.
    


Intervention name(s): VARIVAX™ New Seed Process; VARIVAX™ 2007 process; M-M-R II™
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Varicella virus vaccine live manufactured with a new seed process; Varicella virus vaccine live manufactured with the 2007 process; Measles, Mumps, and Rubella virus vaccine live
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention