bioihbjkbjnl/mcl2 huggingface dataset:
A First-In-Human SAD and MAD Study to Evaluate the Safety, Tolerability, PK and PD of SC Administered ALTB-268 in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study with ALTB-268 will determine the safety, tolerability, pharmacokinetics and
      pharmacodynamics of single and multiple ascending doses of ALTB-268 in healthy volunteers.
    

Detailed description: 
      This is a Phase I, first-in-human, randomized, double-blind, single and multiple ascending
      dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of
      subcutaneously administered ALTB-268 in healthy volunteers. Up to 40 and 24 healthy
      volunteers will be recruited in single and multiple ascending doses, respectively.

      The primary objective is to assess the safety and tolerability of subcutaneously (sc)
      administered ALTB-268 in healthy volunteers. The secondary objective is to assess the plasma
      pharmacokinetics of sc administered ALTB-268 in healthy volunteers. The exploratory
      objectives are to assess the pharmacodynamics and evaluate immunogenicity of sc administered
      ALTB-268 in healthy volunteers.
    

Intervention name(s): ALTB-268; Placebo
Intervention type(s): Biological; Other
Intervention description(s): monoclonal antibody; formulation buffer
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Study consists of 2 parts: Part A: a single ascending dose (SAD) and Part B: multiple ascending dose (MAD).
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled HH-120 Aerosol in Healthy Volunteers
Condition: COVID-19 Respiratory Infection
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blinded, placebo controlled, dose escalation study of
      HH-120 in healthy adult volunteers. HH-120 is a novel inhalable biologic being developed for
      COVID-19 treatment. The study aims to evaluate the safety, tolerability and pharmacokinetic
      profile of HH-120 administered by aerosol inhalation after single and multiple ascending
      doses.
    

Detailed description: 
      Approximately 48 participants will be sequentially enrolled into either 1 of 3 SAD cohorts
      (n=8 per cohort), or 1 of 3 MAD cohorts (n= 8 per cohort). An adaptive dose escalation
      schedule will be employed for both SAD and MAD parts of the study.
    

Intervention name(s): HH-120 Dose 1; HH-120 Dose 2; HH-120 Dose 3; Placebo
Intervention type(s): Biological; Biological; Biological; Drug
Intervention description(s): Dose level 1 of HH-120; Dose level 2 of HH-120; Dose level 3 of HH-120; Placebo to match
Other intervention name(s): HH-120; HH-120; HH-120
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study to Evaluate the Effect of Simvastatin, Losartan and Pioglitazone on Patients With Peripheral Arterial Disease.
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Part A. The purpose of this study is to assess the effects of 6 weeks of treatment with,
      simvastatin, losartan or pioglitazone compared to placebo on the RNA expression profile of
      lower extremity peripheral arterial atherosclerotic plaque. Part B. The effect of
      simvastatin, losartan or pioglitazone compared to placebo on protein and lipid biomarkers in
      lower extremity peripheral arterial atherosclerotic plaque.
    

Detailed description: 
      This is a multi-center, randomized, double-blind, placebo-controlled, 6 week study. The study
      consists of 3 separate sub-studies in which patients undergoing bilateral lower extremity
      peripheral artery atherectomy will receive one of three FDA approved drugs known to have
      beneficial effect on the risk of cardiovascular disease. Patients will be selected for the
      particular sub-study based on a series of entry criteria and then randomized to the
      particular agent or placebo for 6-weeks.
    

Intervention name(s): Simvastatin; Losartan; Pioglitazone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 40 Mg. tablet, 1 tablet daily; 50 mg., tablets, 1 tablet once daily; 30 mg, tablet, 1 tablet once daily
Other intervention name(s): HMG-CoA reductase; Cozaar; Systematic (IUPAC)
Intervention MeSH terms: Pioglitazone; Losartan; Simvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Peripheral Arterial Disease; PAD; Lower extremity peripheral arterial atherosclerotic plaque; RNA Expression; Lipid Biomarkers
Transition of Diabetes Care From Pediatric to Adult Healthcare Providers.
Condition: Transition
Study type: Interventional

Summary: 
      A dedicated pre-transition class, as proposed in this study, could help facilitate a smooth
      transition between pediatric and adult diabetes care. The innovation in this study is that
      these classes are an opportunity for the patients and their families to meet with the Adult
      Diabetes Team consisting of a diabetologist, RD and CDE, prior to the transition of care.
      Having met them would then increase the likelihood of compliance with the Adult clinic
      visits.
    


Intervention name(s): Transition classes
Intervention type(s): Other
Intervention description(s): 90 minutes spent with patients and their families (separately) to review the changes and challenges associated with healthcare transition and help alleviate some of the barriers traditionally associated with this process.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Food, Fun, & Fitness Internet Program for Girls: Outcome Evaluation
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this project is to reduce health disparities in obesity risk among 8-10 year
      old African American girls using a culturally sensitive and developmentally appropriate
      internet-based program with no face-to-face interaction. This study will conduct an outcome
      evaluation to test short and longer term effects on obesity risk.
    

Detailed description: 
      This research will conduct an outcome evaluation on a promising web based obesity prevention
      program for 8-10 year old African American girls. A pilot study with 80 girls established its
      feasibility: recruitment goals were met; attrition rates were < 10%; logon rates to the
      online program were 74.5%; and statistically significant increases in fruit and vegetable
      consumption and time spent being physically active were observed. The outcome evaluation will
      recruit 400 child-parent pairs to examine short and longer term effects of the program on
      obesity risk. It will also conduct mediation analyses to examine pathways of effect. At the
      end of the study, the web based program will be hosted on the CNRC web site. Although the use
      of the internet as a method for changing health behavior is not new, the use of an internet
      program alone, with no face to face interaction, is novel. This is one of the first programs
      to attempt this, particularly in an at-risk population.
    

Intervention name(s): Food, Fun, & Fitness Internet Program for Girls
Intervention type(s): Behavioral
Intervention description(s): This is an 8 episode intervention, delivered entirely over the internet. Each episode, girls will view an interactive story in which 6 8-10 year old African American characters attempt to solve a mystery about their town. The online program will include information about healthy nutrition (i.e., consuming more fruit, vegetables, water) and physical activity. There will be two groups; one group (the experimental group) will view the interactive story and participate in key behavior change procedures, such as personal goal setting, problem solving, and self monitoring activities. The second group (the active comparator group) will view the online stories but will not engage in key behavior change procedures.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: physical activity; fruit and vegetable; water; girls; African American; online
Preventing Fetal Body and Brain Size Reduction in Low-income Smoking Mothers: A Randomized Clinical Trial
Condition: Fetal Body Size; Fetal Brain Size
Study type: Interventional

Summary: 
      The purpose of this study is to find out if folic acid prevents of the reduction of fetal
      body and brain size in infants whose mothers smoke.
    

Detailed description: 
      Smoking during pregnancy remains a common practice despite smoking cessation programs offered
      to mothers. Only 20-40% of women quit smoking during pregnancy which implies that a majority
      of smokers continue smoking despite the associated feto-infant morbidity and mortality. It is
      therefore important to identify ways and means of protecting these infants as they grow and
      develop during intrauterine life. In this study, we propose to assess the utility of
      higher-strength folic acid (4mg) combined with smoking cessation programs as compared to
      standard of care (smoking cessation program and low-strength (0.8mg) folic acid) in reducing
      the level of morbidity (specifically fetal body and brain size) sustained by infants of
      smokers
    

Intervention name(s): Folic Acid
Intervention type(s): Dietary Supplement
Intervention description(s): 4mg of higher strength folic acid once a day until delivery
Intervention MeSH terms: Folic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Fetal body size; Fetal brain size; Folic acid
Incontinent Urinary Diversion Using an Autologous Neo-Urinary Conduit
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to see if the Neo-Urinary Conduit(NUC), which is made in the
      laboratory from a combination of a patient's own cells and other materials can be used to
      form a conduit to safety allow urine flow from the kidneys to outside the body after radical
      cystectomy in patients with bladder cancer.
    

Detailed description: 
      The NUC under investigation is a regenerative medicine product comprised of the patient's own
      smooth muscle cells, procured from a fat biopsy. Tengion has developed appropriate culture
      conditions to reproducibly generate the necessary quantities of SMC in vitro from autologous
      adipose tissue biopsies. The NUC is produced at Tengion's Good Manufacturing Practices (GMP)
      qualified clinical production facility. In this process, smooth muscle cells (SMC) obtained
      from an adipose tissue biopsy are propagated ex-vivo for approximately 3 - 4 weeks. At the
      end of this process, the SMCs are seeded onto the surface of a biodegradable PGA/PLGA mesh
      scaffold to form the NUC. The NUC is shipped to the investigative site for surgical
      implantation. Over time, the NUC should facilitate the regeneration of urinary tract tissue.
    

Intervention name(s): Neo-Urinary Conduit
Intervention type(s): Device
Intervention description(s): Implantation with the autologous Neo-Urinary Conduit
Other intervention name(s): NUC
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bladder cancer; radical cystectomy; incontinent urinary diversion
Multi-Center Study of Different Doses Domperidone in Feeding Intolerance
Condition: Feeding Intolerance; Premature Birth; Domperidone Overdose; Gastric Retention
MeSH terms: Premature Birth
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this clinical multi-center study is to determine whether different doses of
      domperidone are effective in the treatment of feeding intolerance in premature infant
    

Detailed description: 
      the premature infant have been divided into four group.The first group take the 0.2mg/kg/tds
      domperidone as treatment ,while the other group take the 0.4mg/kg/tds
      domperidone,0.6mg/kg/tds domperidone and the placebo respectively .

      An objective index has been decided to evaluate the severity of feeding intolerance in the
      premature infant. 3kg/kg 5% glucose will be injected into the gastric tube .The residual
      glucose will be drawed out from the gastric tube. The residual percentage is the main result
      of the study.

      The main result will be compared by the secondary result to help to explain the accuracy. The
      secondary result is the percentage of residual milk drawed out from the gastric tube from how
      many milk the infant take 3 hours ago.

      Any adverse effect will be recorded and analysed to figure out whether is associate with the
      domperidone.
    

Intervention name(s): Low dose; normal dose; over dose; Glucose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.2mg group-The premature infant will be fed with 0.2mg/kg/tds domperidone and will be tested the residual glucose everyday in a 7-days period.; 0.4mg group-The premature infant will be fed with 0.4mg/kg/tds domperidone and will be tested the residual glucose everyday in a 7-days period.; 0.6mg group-The premature infant will be fed with 0.6mg/kg/tds domperidone and will be tested the residual glucose everyday in a 7-days period.; Glucose group-The premature infant will be fed with glucose and will be tested the residual glucose everyday in a 7-days period.
Other intervention name(s): Domperidone Suspension(Motilium), B12200018238; Domperidone Suspension(Motilium), B12200018238; Domperidone Suspension(Motilium), B12200018238; 5% Glucose
Intervention MeSH terms: Domperidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: feeding intolerance; premature infant; domperidone
Effect of Different Exercises on Quality of Life of Leukemia Patients.
Condition: Quality of Life; Acute Lymphoblastic Leukemia; Exercise
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Interventional

Summary: 
      -  To compare between modified strength training program and aerobic exercises on quality
           of life on children with Acute Lymphoblastic Leukemia.

        -  To compare between modified strength training program and aerobic exercises on
           functional capacity on children with Acute Lymphoblastic Leukemia.
    

Detailed description: 
      This study will be done to determine any exercise from aerobic exercises or modified strength
      training program will be more effective on quality of life and functional capacity on
      children with Acute Lymphoblastic Leukemia .Acute Lymphoblastic Leukemia is wide spread in
      the world and the children with this disease are fragile so must know the most program
      effect.
    

Intervention name(s): Aerobic exercises; Modified strength training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Aerobic exercises will do by using treadmill for children of study group A. it will consist of (max.incline15% - max. speed - heart rate grips and wireless chest strap - smooth virtual fitness trainer - smooth drop folding frame - impression shock absorption cushioning system).; Dumbbells will be used to conduct the modified strength training program for children of group B. This exercises included five exercises for the main muscle groups: bench press, leg press, seat row, leg extension and lat pull down.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Experimental controlled randomization using Block Stratified Randomized Software program, after obtaining informed consent from illegible patient or his caregiver.
Masking: None (Open Label)
Primary purpose: Other
A Study of Lifestyle Intervention in Overweight or Obese Women With Early Stage Breast Cancer
Condition: Weight
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to test the hypothesis that an intervention of lifestyle
      modification will positively impact women with breast cancer who are overweight and/or obese.
      To that end, our primary endpoint is to examine the effects of a practical lifestyle
      intervention that can be implemented by overweight or obese women (BMI greater or equal to
      25) with early stage breast cancer (I-III) on outcomes such as body weight and change in BMI
      over the course of the study.
    

Detailed description: 
      -  Primary endpoint: To examine the effects of a practical lifestyle intervention that can
           be implemented by overweight or obese women (BMI greater or equal to 25) with early
           stage breast cancer (I-III) on outcomes such as body weight and change in BMI over the
           course of the study.

        -  Secondary endpoint: To assess the impact of such intervention on lipid profiles and
           hemoglobin A1C. The study group will be compared with a historical control group of
           patients with early stage breast cancer who are obese or overweight who were not given
           the intervention

        -  Secondary endpoint: To examine whether an active intervention program will lead into
           longstanding lifestyle modification in breast cancer patients with a BMI greater or
           equal to 25.
    

Intervention name(s): Diet and exercise
Intervention type(s): Behavioral
Intervention description(s): Upon enrollment, the patient will be asked to meet with a dietitian to assess the individual patient's current diet and exercise routines. In the first session, the dietitian will provide individual counseling and together with the patient devise weight loss / exercise strategies that fit the patients' lifestyle. Following the initial assessment, patients will embark on a weekly program, with weekly meetings lasting 30min - 1h. Patients will be asked to record meal portions weekly in a Food Log (Appendix B), according to the established goal. At each meeting, the dietitian will review the Food Log with the patient and evaluate progress.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: BMI, Lipid profile
Safety Study of AEM-28 to Treat Refractory Hypercholesterolemia
Condition: Hypercholesterolemia; Hyperlipoproteinemia Type II
MeSH terms: Hypercholesterolemia; Hyperlipoproteinemias; Hyperlipidemias
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of the first part of this study is to determine the safety and tolerability of a
      single dose of AEM-28, an apolipoprotein E mimetic, in subjects with high total cholesterol
      who are otherwise healthy subjects. The pharmacokinetics and pharmacodynamics of AEM-28 will
      also be evaluated.

      The second part of this study will be a multiple ascending dose evaluation of AEM-28 in
      patients with refractory hypercholesterolemia.

      AEM-28 has demonstrated significant lipid lowering activity and positive effects on the
      artery wall. AEM-28 is being developed for the treatment of homozygous familial
      hypercholesterolemia.
    


Intervention name(s): AEM-28; Normal Saline
Intervention type(s): Drug; Drug
Intervention description(s): Solution for injection; 0.9% saline for injection
Other intervention name(s): apolipoprotein E mimetic; 0.9% NaCl; Sterile Normal Saline
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hypercholesterolemia; apolipoprotein E; First in Human; Apolipoprotein E (ApoE); Apolipoprotein E Mimetic (AEM)
TAK-438 - Safety, Blood Levels & Effects of Repeated Doses
Condition: Erosive Esophagitis(EE); Gastroesophageal Reflux Disease (GERD)
MeSH terms: Gastroesophageal Reflux; Esophagitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
      TAK-438 in healthy, non-Japanese men male subjects following a randomized, double blind,
      placebo controlled, sequential panel, multiple-dose schedule.
    

Detailed description: 
      The drug being tested in this study is called TAK-438. TAK-438 is being tested to find a safe
      and well-tolerated dose. This study looked at pharmacokinetic (effect of the body on the
      drug) and pharmacodynamic properties (effect of the drug on the body) as well as look at lab
      results and side effects in people who took TAK-438. This study was designed as a randomized,
      sequential-panel, multiple repeat dose study.

      The study population consisted of 4 Cohorts with 12 participants in each Cohort; with 9
      participants randomized to receive a single dose of TAK-438, and 3 participants to receive
      placebo. Participants in each Cohort received a single dose of study drug once daily after a
      10-hour fast. The starting dose was 10 mg followed by administrations of 20, 40, and 30 mg.

      This single-centre trial was conducted in the United Kingdom. The overall time to participate
      in this study was up to 37 days. Participants made 2 visits to the clinic for screening, one
      11-day period of confinement to the clinic, and 2 further visits after the confinement
      period. All participants were contacted by telephone 7 days after last dose of study drug for
      a follow-up assessment.
    

Intervention name(s): TAK-438; TAK-438 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-438 tablets; TAK-438 placebo-matching tablets
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Drug therapy
Citalopram Versus Citalopram Plus Pindolol in Major Depressive Disorder
Condition: Major Depressive Disorder; Antidepressant Treatment Response
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine whether the speed of the clinical antidepressant
      action of citalopram can be accelerated by administering double doses of pindolol (15 mg/day,
      tid) which presumably should lead to increased 5-HT1A autoreceptor occupancy.
    

Detailed description: 
      Design, Settings, and Participants. A randomised, double-blind, placebo-controlled trial with
      MDD patients allocated to two treatment arms: citalopram + pindolol versus citalopram +
      placebo. Participants: outpatients with a depressive episode (DSM-IV criteria) were selected
      from a general hospital.
    

Intervention name(s): Pindolol
Intervention type(s): Drug
Intervention description(s): Pill orally administered. 15 mg/day t.i.d.
Intervention MeSH terms: Pindolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major depressive disorder, citalopram, pindolol, HDRS