bioihbjkbjnl/mcl2 huggingface dataset:
Anti-PD-1 Alone or Combined With Autologous Cell Therapy in Advanced NSCLC
Condition: Lung Cancer; Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A randomized controlled study to compared the clinical effects and safety of immunotherapy
      with dendritic cells and cytokine-induced killer cells administered with anti-PD-1 antibody
      in advanced NSCLC.
    


Intervention name(s): Anti-PD-1 plus DC-CIK; Anti-PD-1 alone
Intervention type(s): Biological; Biological
Intervention description(s): Patients will receive pembrolizumab 100mg every three weeks until disease progression, unacceptable toxicity or patient refusal. DC-CIK Immunotherapy: Mononuclear cells were collected aseptically with blood cell separator composition apheresis, and cultured DC-CIK cells for 10-14 days. Cells were infused back to the patients in 3 times via intravenous infusion .Patients will received at least 2 cycles of DC-CIK Immunotherapy along with 4 dosage of anti-PD-1 antibody treatment. If the evaluation of the treatment is partial response or stable disease, additional cycles were eligible.; Patients will receive pembrolizumab 100mg every three weeks until disease progression, unacceptable toxicity or patient refusal.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of High Protein Diet on Adiponectin and Inflammation Among Overweight and Obese Children
Condition: Body Mass Index Quantitative Trait Locus 5 Disorder; Tangier Disease
MeSH terms: Tangier Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators aimed to determine the effects of HP diet on adiponectin and inflammatory
      factors among overweight and obese children.
    


Intervention name(s): nutrition intervention
Intervention type(s): Other
Other intervention name(s): high protein diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Safety and PK Study of NOV-205 to Treat Chronic HCV Who Fail Standard Therapy
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this research trial is to find out whether NOV-205 is well tolerated compared
      to placebo (salt water) in people with hepatitis C. In addition, this trial will test how
      NOV-205 is absorbed by your body after single and multiple doses of the trial drug, and it
      will look for early signs of therapeutic activity (decreases in indicators in the blood for
      the hepatitis C virus and for liver damage). This is known as pharmacokinetics (PK). NOV-205
      is an experimental drug. "Experimental" means that the trial drug is currently being tested
      and is not approved for sale in the United States by the Food and Drug Administration (FDA).
      However, NOV-205 has been approved by the Russian Federation for treatment of liver diseases
      including hepatitis C. Clinical studies in that country showed that subjects treated with
      NOV-205 alone had decreased indicators in the blood for the hepatitis C virus and for liver
      damage.
    

Detailed description: 
      This Phase 1b trial aims to evaluate the pharmacokinetic profile of NOV-205, and in
      comparison to placebo, identify early signs of antiviral activity (with a quantitative
      reduction of >0.5 log10 in serum HCV RNA level (Elbeik, 2004)) and establish a safety profile
      of NOV-205 as monotherapy in subjects with chronic HCV who are non-responders to treatment
      with pegylated interferon plus ribavirin. This trial will also explore the effect of NOV-205
      on serum biochemical markers of liver damage (e.g. alanine aminotransferase, ALT) as
      indications of biologic activity. Results of this trial will guide the design of future Phase
      2 studies of NOV-205 in chronic hepatitis C subjects.
    

Intervention name(s): NOV-205
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Keywords: chronic HCV; Failed treatment; genotype 1; failed treatment with pegylated interferon plus ribavirin
Problem-Solving Therapy for Depressive Symptoms and Quality of Life in Stroke Survivor-Caregiver Dyads
Condition: Stroke; Quality of Life; Depression
MeSH terms: Stroke; Depression
Study type: Interventional

Summary: 
      The purpose of this feasibility study is to determine whether it is practical and helpful to
      provide problem-solving therapy to stroke survivors and their spouses/partners (caregivers)
      together. It will also compare the experiences of participants who receive problem-solving
      therapy to those who receive stroke-related health education.

      Many stroke survivors and caregivers report feeling sad or blue at some point after the
      stroke. These feelings can impact quality of life. Encountering problems is a part of daily
      life. These problems can be big or small, but sometimes they can pile up and feel
      overwhelming, contributing to feelings of sadness. Problem-solving therapy is a tool that
      teaches structured ways to address current problems or challenges in your life.

      Participants who are assigned to receive problem-solving therapy will work with a research
      team member for six, one-hour sessions. During each session, participants will identify a
      problem (big or small) and create a plan to work on that problem.

      Participants who are assigned to receive stroke-related health education will work with a
      research team member who will teach them about various topics related to stroke over six,
      one-hour sessions. Each session will cover information about a different topic related to
      stroke.

      Outcomes data will be collected at approximately 4 weeks, 8 weeks, and 13 weeks from
      baseline.
    


Intervention name(s): Problem-Solving Therapy; Stroke-Related Health Education
Intervention type(s): Behavioral; Other
Intervention description(s): Problem-Solving Therapy is a brief psychosocial intervention for management of depressive symptoms. Participants will have six, one-hour sessions with an interventionist to learn a structured approach to problem-solving.; The stroke-related health education program will teach participants about various topics related to stroke. Participants will have six, one-hour sessions with an interventionist to learn about different topics related to stroke.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Cognitive Training for Patients With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder; Other Primary Psychotic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      This research on cognitive training addresses the following questions:

        1. Does cognitive training lead to improved cognition, functional abilities, psychiatric
           symptoms, treatment adherence, or quality of life in patients with psychoses?

        2. What are the neurocognitive and non-cognitive factors that predict good outcomes
           following cognitive rehabilitation? In addition to verbal learning and memory, immediate
           verbal memory, vigilance, and executive functioning, the cognitive training intervention
           attempted to improve prospective memory ability (i.e., the ability to remember to do
           things in the future, such as take medications or attend a doctor's appointment).
    


Intervention name(s): Cognitive Training
Intervention type(s): Behavioral
Intervention description(s): 12-week compensatory cognitive training in group format
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Optimal Dose of Omeprazole After Endoscopic Treatment of Bleeding Peptic Ulcers
Condition: Bleeding Peptic Ulcers Disease
MeSH terms: Peptic Ulcer; Peptic Ulcer Hemorrhage; Ulcer; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      Bleeding peptic ulcers are one of the major causes of morbidity and mortality for hospital
      emergency admissions.The initial treatment is endoscopic therapy followed by intravenous
      omeprazole. However the optimal dosage of omeprazole is not known. We conducted this study to
      find out the optimal dosage in such clinical scenario.
    

Detailed description: 
      Introduction

      Peptic ulcer bleeding (PUB) is a common and life threatening condition. Intravenous infusion
      of high dose omeprazole (80mg as bolus followed by 8 mg/hr for 72 hours ie 652 mg/72 hrs)
      after endoscopic therapy resulted in greater reductions of re-bleeding than did placebo. Thus
      the above regime became our departmental protocol. However, there is some evidence that both
      high dose and a regular dose of omeprazole (40mg once a day followed by a saline infusion ie
      120mg/72 hrs) would be equally effective. We calculated that high dose regimen is about S$
      500 more expensive. The aim of our study is to determine the equivalence of both regimes in
      preventing re-bleeding rate (primary end-point), surgery and mortality in PUB patients.

      Study design This is a single institution prospective randomized double-blind study. All
      patient with PUB (Forrest classification I, IIa and IIb: spurting or oozing bleeding, visible
      vessels and clot) had endoscopic treatments (adrenaline injection and/or heater probe). After
      successful endoscopic hemostasis, patients are randomized to receive a high or regular dose
      of omeprazole infusion. After 72 hours, both groups of patients are given oral omeprazole
      40mg daily for 4 weeks. All patients are evaluated at the clinic at the end of 4 weeks. The
      primary end-point is rebleeding. Other secondary endpoints measured are surgery, duration of
      hospital stay and death.
    

Intervention name(s): Omeprazole
Intervention type(s): Drug
Intervention description(s): intravenous 80mg bolus followed by 8mg / hr for 3 days
Other intervention name(s): intravenous 40 mg om for 3 days
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Rebleeding after endoscopic therapy
Synergy Between PCI With TAXUS and Cardiac Surgery: SYNTAX Extended Survival
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational

Summary: 
      An investigator-driven, retrospective study to compare long-term survival-data (10-year
      follow-up) of patients with coronary artery disease (CAD), previously enrolled in the SYNTAX
      trial, who were randomized to percutaneous coronary intervention (PCI) using a paclitaxel
      (TAXUS) drug-eluting-stent (DES) or coronary artery bypass grafting (CABG).
    


Intervention name(s): No intervention will take place for this retrospective and observational study.
Intervention type(s): Other
Intervention description(s): No intervention will take place for this retrospective and observational study.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients enrolled in the SYNTAX trial and registries had to be diagnosed with three-vessel
        (3VD) or left main (LM) coronary artery disease. The vessels (diameter ≥1.5 mm and
        significant stenosis > 50%) deemed important to revascularize were determined by the Heart
        Team prior to randomization. The group of 3VD consists of patients with significant
        stenosis in vessels supplying all three major epicardial territories in absence of LM
        disease, as determined by the site investigators. The group of patients with LM disease
        consists of patients with a significant stenosis of the left main coronary artery,
        irrespective of additional vessel disease.
      
Keywords: coronary artery bypass grafting; percutaneous coronary intervention; drug eluting stent; survival status; long-term follow-up; complex coronary artery disease
Safety Study of Analgesia After Craniotomy Surgery With End Tidal (ET) Carbon Dioxide (CO2) Monitoring
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      This research is being done to compare two methods of giving fentanyl, a narcotic often given
      to patients following brain surgery and determine if one method has more side effects than
      the other. Both of these methods are available in the postoperative treatment of pain. This
      research also is being done to determine if patients receiving narcotic pain medicine will
      benefit from additional monitoring of carbon dioxide levels. Since narcotic pain medicines
      can slow down breathing, The investigators want to see if measuring exhaled carbon dioxide
      levels will help identify a slower breathing rate and improve safety.
    

Detailed description: 
      See brief summary
    

Intervention name(s): Fentanyl; Fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): 25-50 mcg every 20 minutes; 20mcg/demand dose with an 8 minute lock out
Other intervention name(s): Fentanyl PRN; Fentanyl PCA
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pain management; opioid analgesic therapy; safety; craniotomy
Seamos Activas: Increasing Physical Activity Among Latinas
Condition: Inactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The overarching goal of this project is to develop a culturally congruent intervention to
      increase levels of physical activity among sedentary Latinas (i.e., Latina/Hispanic women).
      The first phase will involve culturally and linguistically modifying an existing
      evidenced-based intervention, founded on the Transtheoretical Model and Social Cognitive
      Theory, to target sedentary Latinas. Then, we will conduct a pilot randomized clinical trial
      to test whether the culturally-modified individually tailored intervention increases physical
      activity levels in comparison to standard care comprised of bilingual health education
      booklets.
    

Detailed description: 
      While the general United States population is suffering from an epidemic of sedentary
      lifestyle, Latinos are even more sedentary than their non-Hispanic white counterparts.
      Notably, Latinos suffer from greater rates of morbidity and mortality of conditions
      associated with being sedentary than non-Hispanic whites. One concern is that due to cultural
      artifacts, socioeconomic circumstances, and language barriers, Latinos have limited access to
      public health interventions that promote active lifestyles. The current study will advance
      nursing science by using a theory-based computer-run expert system to provide an effective
      physical activity intervention for this underserved population. The consent form was
      completed by all participants and describes the nature and purpose of the study, procedure,
      risks and benefits to participating, alternative therapies available, and confidentiality.
    

Intervention name(s): Intervention; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Culturally-modified, individually tailored physical activity print materials; Bilingual health education booklets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: physical activity; Latinas
Study To Assess the Safety and Tolerability of PBF-509 in Male Healthy Volunteers
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      No clinical trials with PBF-509 in humans have been performed to date. Only preclinical
      studies have been done to assess the pharmacology and pharmacokinetics, the safety and the
      toxicological profile of the PBF-509.

      An initial testing of PBF-509 in humans is planned, starting with the first-into-man clinical
      trial where a single oral, dose-escalating, and placebo-controlled design will be
      implemented.
    


Intervention name(s): PBF-509; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Adenosine A2a receptor antagonist; adenosine receptor modulator; Cancer
Fever After Simultaneous Versus Sequential Vaccination in Young Children
Condition: Fever After Vaccination; Fever; Febrile Seizure
MeSH terms: Seizures; Seizures, Febrile; Fever; Hyperthermia
Study type: Interventional
Phase: Phase 4

Summary: 
      A prospective, randomized open-label clinical trial that will be conducted during the
      2017-2018 influenza season. During the 2017-2018 season, approximately 280 children will be
      enrolled at Duke University Medical Center and Kaiser Permanente Northern California.
      Eligible children will be randomized to receive simultaneous or sequentially administered US
      licensed PCV13, US-licensed DTaP vaccine, and US-licensed inactivated influenza vaccine
      (IIV). Children in the simultaneous group will receive PCV13, DTaP, and IIV vaccines at Visit
      1, and then return for a health education visit without vaccination about 2 weeks later
      (Visit 2). Children in the sequential group will receive both PCV13 and DTaP without IIV at
      Visit 1, and then will receive IIV and health education about 2 weeks later (Visit 2).
      Parents will record the occurrence of fever, solicited adverse events, medical care
      utilization, and receipt of antipyretics over 8 days following Visit 1 and Visit 2. In
      addition, febrile seizures and serious adverse events will be recorded for the entire study
      period (from enrollment through 8 days following the Visit 2) as determined through parental
      report and chart review. Parental perceptions about their child's vaccine schedule will be
      assessed on the 8th day following Visit 2.
    


Intervention name(s): PCV13; DTaP; IIV
Intervention type(s): Biological; Biological; Biological
Intervention description(s): ACIP Recommended vaccine; ACIP Recommended vaccine; ACIP Recommended vaccine
Other intervention name(s): 13-valent Conjugate Pneumococcal Vaccine; Diphtheria, Tetanus, and Acellular Pertussis Vaccine; Quadrivalent Inactivated Influenza Vaccine; IIV4; Flu Vaccine
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza vaccine; fever following vaccination; PCV13 vaccine; DTaP vaccine; pneumococcal vaccine
Efficacy, Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates
Condition: Rotavirus Gastroenteritis
MeSH terms: Gastroenteritis
Study type: Interventional
Phase: Phase 3

Summary: 
      This phase III trial aims to assess the efficacy, safety and immunogenicity of Rotavirus RV3
      Vaccine (Bio Farma) in neonates, lot-to-lot consistency, and antigen interference with
      co-administered EPI vaccines
    

Detailed description: 
      This study is a randomized, double-blind, placebo-controlled study to investigate the
      efficacy, safety and immunogenicity following three doses of rotavirus RV3 vaccine (Bio
      Farma) administered as a neonatal schedule
    

Intervention name(s): Rotavirus RV3 Vaccine (Bio Farma); Placebo
Intervention type(s): Biological; Other
Intervention description(s): Each 1 mL dose of the final product of oral liquid rotavirus vaccine contains > 5x10^6 fcfu/mL rotavirus vaccine strain RV3; Each 1 mL dose of placebo contains 30% of sucrose in DMEM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Rotavirus; Vaccine
A Study to Gain Information How Well Dexpanthenol Derma Cream Helps the Face Skin to Recover After Cosmetic Lasering
Condition: Erythema; Skin Recovery
MeSH terms: Erythema
Study type: Interventional

Summary: 
      In this study, researchers want to learn more about the effect of dexpanthenol cream on skin
      recovery and reduction of skin rash after a dermatological procedure (ablative laser) on the
      face for treatment of fine wrinkles, scars and open pores in adult women.

      After the dermatological procedure, participants will return within 3 weeks for 4 visits to
      the study center to investigate the skin conditions such as redness, irritation, softness and
      possible side effects. In addition, study participants will be asked about their general
      acceptance of dexpanthenol cream.
    

Detailed description: 
      The primary objective is to evaluate the efficacy of the test product to aid skin recovery
      and reduction of erythema after ablative lasering on the face.

      Secondary objectives comprise clinical efficacy with respect to skin hydration, softness,
      vitality, appearance etc. and skin recovery, consumer judgement of product performance and
      acceptability, and safety.
    

Intervention name(s): BAY207543 (Bepanthol); Semisolid vaseline
Intervention type(s): Drug; Other
Intervention description(s): Product is applied to one hemiface.; Product is applied to one hemiface.
Intervention MeSH terms: Petrolatum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Skin cream; Ablative lasering; Skin hydration; Consumer satisfaction; Sensorial perception
Clinical Safety and Tolerability Study of gpASIT+TM and gpASIT+TM/Immunoregulating Adjuvant to Treat Seasonal Grass Pollen Rhinoconjunctivitis
Condition: Seasonal Allergic Rhinoconjunctivitis
MeSH terms: Conjunctivitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of gpASIT+TM administered
      subcutaneously in absence or in presence of an immunoregulating adjuvant in grass pollen
      allergic patients.
    


Intervention name(s): gpASIT+TM; gpAST+TM/adjuvant; Placebo solution
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 1 subcutaneous injection every 7 days, during 29 days.; 1 subcutaneous injection every 7 days, during 29 days; 1 subcutaneous injection every 7 days, during 29 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effects of Butyrate Enemas on Visceral Perception
Condition: Visceral (Hyper)Sensitivity
MeSH terms: Hypersensitivity
Study type: Interventional

Summary: 
      During this double blind, placebo controlled, randomised cross over study, healthy volunteers
      received an enema once daily for one week containing either placebo (saline), 50mM butyrate
      or 100mM of butyrate. Before and directly after each test period a barostat protocol was
      performed to measure parameters for visceral perception.
    


Intervention name(s): Butyrate
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: butyrate, visceral perception, compliance