bioihbjkbjnl/mcl2 huggingface dataset:
Tolerance and Pharmacokinetic Study of Chlorogenic Acid to Advanced Glioblastoma
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study:

      Determining the Maximum Tolerated Dose (MTD), Dose-Limiting Toxicity (DLT), pharmacokinetics
      characteristic, and dosage regimen of phase II/III of Chlorogenic acid for injection in the
      advanced Glioblastoma Patients ;
    

Detailed description: 
      1. Investigate the tolerance of Chlorogenic acid for injection in human body, determine the
           Maximum Tolerated Dose (MTD) and Dose-Limiting Toxicity (DLT) of Chlorogenic acid for
           injection in the advanced Glioblastoma Patients ;

        2. Determine the human pharmacokinetics characteristic of Chlorogenic acid for injection;

        3. Preliminary observation the effectiveness and effective dose;

        4. Provide the basis for the dosage regimen of phase II/III.
    

Intervention name(s): Chlorogenic acid
Intervention type(s): Drug
Intervention description(s): Chlorogenic acid for injection is polyphenols, micromolecular and un-endogenous substance. It might play the role of cancer treatment via balancing tumor micro-environmental immune status according to the stability and rationality of immunodeficiency and endogenous immune material expression around the tumor. Chlorogenic acid for injection is made from chlorogenic acid (purity≥98%) which is extracted from folium cortex eucommiae.Chlorogenic acid and its preparations have not been reported as chemical drug and marketed around the world.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cognitive Remediation Therapy (CRT) in Adolescents With EOS
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Cognitive Remediation Therapy (CRT) can enhance cognitive performance in schizophrenia
      improving functional outcome. But most of the studies have involved participants who are in
      average in their mid 30s, and little is known about the efficacy of CRT in adolescents with
      early-onset schizophrenia (EOS). The aim of this study is to investigate efficacy of CRT in
      improving cognitive performance and functional outcome in adolescents with EOS. We expect to
      find that CRT improves cognitive and functional outcomes in adolescents with schizophrenia.
    

Detailed description: 
      Early-onset schizophrenia (EOS) is associated with worse course and poor outcome than
      adulthood schizophrenia. Cognitive deficits are known to be a core feature in EOS, with large
      deficits on almost all cognitive domains. Importantly, cognitive deficits are known to be
      strong predictors of psychosocial and functional outcomes in schizophrenia and also in the
      early-onset form of the illness. Cognitive Remediation Therapy (CRT) is a behavioral training
      based intervention that aims to improve cognitive processes (attention, memory, executive
      function, social cognition or metacognition) with the goal of durability and generalization.
      It has been demonstrated that CRT improve cognitive deficits and functional outcome in adult
      patients but there are very few studies with adolescent samples.

      A controlled randomized study will be carry out with two groups: patients receiving treatment
      as usual plus CRT, and patients receiving treatment as usual (TAU). The independent variable
      is the cognitive remediation treatment. The CRT will be applied according to the manual of
      Wykes and Reeder (2005). The program has a duration of 40 sessions, with two session for
      week. It is carried out individually and utilizes paper and pencil tasks. The main technique
      utilized is the scaffolding in a context of learning without errors.

      The main dependent variable is the cognitive performance measured through neuropsychological
      tests. Other secondary dependent variables are functional outcome and clinical symptoms
      obtained from the psychometric evaluation.

      All participants will be evaluated before and after the experimental intervention in several
      neurocognitive domains, clinical symptoms and functional outcome. The evaluations will be
      carried out by expert evaluators. Intention-to-treat analysis will be carry out using the
      statistical package SPSS v 18.
    

Intervention name(s): Cognitive Remediation Therapy
Intervention type(s): Behavioral
Other intervention name(s): Cognitive training; Cognitive enhancement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: early-onset schizophrenia; adolescents; cognition; cognitive remediation therapy
Safety and Performance Study of the ARGOS-IO (Intraocular) System in Patients With Primary Open Angle Glaucoma (POAG)
Condition: Primary Open Angle Glaucoma (POAG)
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and performance of the ARGOS-IO system in
      patients with POAG and indicated cataract surgery.
    

Detailed description: 
      This prospective, open-label, multi center, single-arm clinical investigation will enroll 22
      consecutive patients.

      Enrollment will be temporarily halted in case a serious adverse device effect (SADE) occurs,
      and Data and Safety Monitoring Board (DSMB) meeting will be conducted as soon as possible.
      The DSMB will then recommend whether to further continue the study as planned, or whether
      enrollment shall be stopped. In order to provide a complete overview of the study to the
      DSMB, an interim analysis will be performed after half of the study population (11-14
      subjects) is enrolled with a minimum follow-up of 1 month. A conclusion for safety will be
      made if in total no more than 2 of the total of 22 patients experience a SADE.

      The primary aim of this study is to show "safety", which will be evaluated based on the
      percentage of subjects who experience a SADE (="non-safety"), as defined in the primary
      endpoints.

      The study will be declared a success if the final non-safety event rate is less than 6% (type
      II error rate of 0.20). The calculation is based on a design optimizing the minimum expected
      sample size with parameters alpha=0.05, beta=0.20, p0=0.75, p1=0.94.
    

Intervention name(s): ARGOS-IO system
Intervention type(s): Device
Intervention description(s): Implantation of ARGOS-IO pressure sensor after cataract surgery on day 0 (V01)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Primary Open Angle Glaucoma; POAG; Glaucoma; Cataract; Surgery; Ocular Pressure
Symptom Management for Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The objective of this study is to test the efficacy of a symptom management treatment
      strategy, Acupuncture/Moxibustion (Acu/Moxa), to improve the symptoms associated with
      Irritable Bowel Syndrome (IBS) in adults.
    


Intervention name(s): Standard protocol; Individualized protocol; Sham acupuncture/Placebo moxa
Intervention type(s): Other; Other; Other
Intervention description(s): Subjects will receive a standard treatment; Subjects will receive an individualized treatment; Subjects will receive sham acupuncture/placebo moxa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Early Oral Feeding vs Traditional Post-operative Care In Emergency Abdominal Surgeries
Condition: Perforated Duodenal Ulcer
MeSH terms: Duodenal Ulcer; Emergencies; Ulcer
Study type: Interventional

Summary: 
      ABSTRACT BACKGROUND: Enhanced recovery after surgery (ERAS) protocols have been widely
      studied in elective abdominal surgeries and have shown better outcomes. However the utility
      of these protocols in emergency abdominal surgeries has not been widely investigated.

      OBJECTIVE: To study the outcomes of application of ERAS protocols in patients undergoing
      perforated duodenal ulcers repairs in emergency abdominal surgeries.

      METHODS: This randomized controlled trial was conducted in Surgical Unit 1 BBH from August
      2018 to December 2019 with a total sample size of 36 patients with the diagnosis of
      perforated duodenal ulcer. Patients were randomly divided in two groups. Group A consisted of
      early oral feeding group and group B consisted of traditional postoperative care group.
      Outcome results studied were the length of hospital stay, duodenal repair site leak, severity
      of pain (VAS score) and duration of post-operative ileus. Results were analysed on SPSS
      version 20 and chi-square and independent t-test were applied.

      KEY WORDS: Perforated duodenal ulcer, ERAS protocol, randomized controlled trial, duodenal
      repair site leak, length of hospital stay, VAS score, post-operative ileus
    


Intervention name(s): Early oral feeding/Enhanced recovery after surgery protocols
Intervention type(s): Dietary Supplement
Intervention description(s): Early oral feeding refers to NG tube and foley's catheter removed within 12 hours and patients allowed oral sips on day 1 with gradual shift to liquid diet after 12 hrs and semisolid food started after 24 hours later.Patients were given i/v antibiotics,painkillers and i/v PPIs and shifted to oral pain killers on 2nd POD.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This randomized controlled trial was conducted in Surgical Unit 1 BBH from August 2018 to December 2019 with a total sample size of 36 patients with the diagnosis of perforated duodenal ulcer. Patients were randomly divided in two groups. Group A consisted of early oral feeding group and group B consisted of traditional postoperative care group. Outcome results studied were the length of hospital stay, duodenal repair site leak, severity of pain (VAS score) and duration of post-operative ileus. Results were analysed on SPSS version 20 and chi-square and independent t-test were applied.
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Perforated duodenal ulcer; Enhanced Recovery After Surgery (ERAS) protocol; Randomized controlled trial; Duodenal repair site leak; Length of hospital stay; Visual analog score; Post-operative ileus
Diet Intervention Spirometry and Tobacco
Condition: Pulmonary Function
Study type: Interventional

Summary: 
      Epidemiologic studies suggest that some nutrients can be affected lung function. Moreover, no
      previous studies have prospectively evaluated the effect of the Mediterranean dietary pattern
      in lung function in smokers. Phase II of the RESET study , a clinical trial to evaluate the
      efficacy of a motivational smoking intervention based on information obtained by spirometry
      (FIS project PI11/01962).
    

Detailed description: 
      Design: Multicenter randomized controlled trial in primary care. Sample: We will recruit 80
      smokers from 35 to 70 years without history of lung disease. Subjects will be randomly
      assigned to control or intervention group (1:1).

      Study variables: We measure socio-demographic, clinical, anthropometry and spirometry data.
      Food consumption will be evaluated by a semi-quantitative food frequency questionnaire (FFQ),
      energy expenditure in physical activity by the Minnesota Leisure Time Activity questionnaire
      and adherence to Mediterranean Diet by a 14-item questionnaire.

      Intervention: Nutritional intervention conducted by a dietitian who designs a nutrition
      program to enhance the traditional Mediterranean diet pattern using new technology as an
      educational tool in primary care: DIET blog. Participants will be referred to a single annual
      visit and one group session per year for two years.

      Analysis: All analyses will be based on intention-to-treat. The results will be considered
      clinically relevant when it detects a difference in lung function (decreased FEV1) >10-12
      ml/year. A p-value of <0.05 will defined statistical significance.
    

Intervention name(s): Mediterranean Diet
Intervention type(s): Behavioral
Intervention description(s): Nutritional intervention conducted by a dietitian who designs a nutrition program to enhance the traditional Mediterranean diet pattern using new technology as an educational tool in primary care: DIET blog. Participants will be referred to a single annual visit and one group session per year for two years.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Mediterranean diet; Smoking/tobacco; Spirometry
Pulmonary Infections Masquerading as Community-Acquired Pneumonia
Condition: Pneumonia
MeSH terms: Pneumonia
Study type: Observational

Summary: 
      The purpose of this research is to identify cases from patients who have been referred for
      consultation to the Infectious Disease Section at the VAMC, Houston, and to compare them with
      other cases of CAP in order to determine whether there are features that might enable non-CAP
      cases to be distinguished from CAP.
    

Detailed description: 
      Guidelines to treat community acquired pneumonia (CAP) have been developed and widely
      promulgated by important professional societies in the past 10 years. The impetus to do so
      came from the observation that practicing physicians were using a wide array of approaches to
      this common infection, many of which were substandard.

      The Infectious Disease Society of America (IDSA) and American Thoracic Society (ATS) have
      been leaders in this field, publishing recommendations separately between 1993 and 2003. The
      PI served on the IDSA committee and coauthored the publication in 2000 and the update in
      2003. In 2004, a decision was made by the two professional societies to merge the committees
      and make a single joint set of recommendations; the PI is a member of that joint committee
      and a new document is being prepared for publication.

      The PI has observed a tendency to apply these guidelines to cases that might masquerade as
      CAP but are actually attributable to other conditions, such as lung cancer, tuberculosis and
      histoplasmosis. Further, the recommendations do not adequately cover pneumonia due to
      Staphylococcus aureus.

      The purpose of the research is to identify cases from the consult records of the Infectious
      Disease Section at the VAMC, Houston, and to compare them with other cases of CAP in order to
      determine whether there are features that might enable non-CAP cases to be distinguished from
      CAP.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Pulmonary infections.
      
Keywords: Community Acquired Pneumonia; CAP
Evaluation Comparing Tau PET Radiotracers, [18F]GTP1 and [18F]PI-2620 or [18F]MK-6240 in Subjects With Normal Cognition or Prodromal to Moderate Alzheimer's Disease
Condition: Alzheimer Disease (AD)
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The study aims to compare tau targeted radiotracers [18F]GTP1 and [18F]PI-2620 or
      [18F]MK-6240 in subjects with normal cognition or prodromal to moderate Alzheimer's disease
      (AD).
    


Intervention name(s): [18F]GTP1; [18F]PI-2620; [18F]MK-6240
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive a bolus IV of approximately 7mCi of [18F]GTP1 radiotracer.; Participants will receive a bolus IV of approximately 5mCi of [18F]PI-2620 radiotracer.; Participants will receive a bolus IV of approximately 5mCi of [18F]MK-6240 radiotracer.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Rapid Evaluation of Baclofen for Treatment of Cocaine Abuse/Dependence - 6
Condition: Cocaine-Related Disorders
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to empirically test a series of medications to: 1) determine
      each medication's efficacy in treatment of cocaine abuse/dependence; 2) find most effective
      dose range for each medication. In this study, baclofen is tested.
    

Detailed description: 
      16-week participation plus a 2 week lead in period. Participants are assigned randomly to
      placebo or baclofen. Participant attend group meetings 3 x/week.
    

Intervention name(s): Baclofen
Intervention type(s): Drug
Intervention MeSH terms: Baclofen
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: Cocaine dependence
Upper Limit of Leucine Intake in Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      When dietary amino acid supplements are consumed by humans they are normally in addition to
      their normal daily requirements. The investigators' laboratory played a leading role in
      defining the estimated average requirement (EAR) and the recommended dietary intake for the
      "essential" amino acids (Dietary Reference Intakes 2005). The other important but less well
      studied component of Dietary Reference Intakes (DRI) is - What is a safe upper limit of
      intake? The investigators now propose to determine the safe upper limits of the dietary
      essential amino acids. The recently published DRI (2005) defines the Tolerable Upper Intake
      Level (UL) as 'the highest average daily nutrient intake level that is likely to pose no risk
      of adverse health effects to almost all individuals in the general population.' As intake
      increases above the UL, the potential risk of adverse effects may increase'. In this
      proposal, the investigators define a novel method to define the safe upper limit where the
      'maximum oxidative potential' of an amino acid identifies the 'metabolic limit' to dispose
      the amino acid. Intakes of amino acid above this level will increase the potential for
      adverse effects to appear.
    

Detailed description: 
      The objective of the study will be to determine the 'metabolic limit' of leucine oxidation in
      healthy young men by:

      A) Measuring leucine oxidation in response to short term (8 hr) graded excess leucine intake
      B) Correlating changes in leucine oxidation with changes in plasma concentrations of
      keto-isocaproic acid (KIC, the first breakdown product of leucine metabolism), other
      essential amino acids, ammonia, urea, creatinine, glucose, insulin, and electrolytes (sodium,
      potassium, chloride) to identify potential biomarkers C) Correlating changes in leucine
      oxidation with changes in urinary excretion of leucine and ketoisocaproic acid (KIC), urea
      and creatinine to identify potential biomarkers
    

Intervention name(s): Leucine Increase
Intervention type(s): Dietary Supplement
Intervention description(s): Graded stepwise increases in leucine intakes (50, 250, 500, 750, 1000, 1250 and 1500mg/kg/day)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Keywords: leucine intake; tolerable upper limit; adults; amino acid supplements; Excessive Leucine Intake
Prevention of Depression in At-Risk Adolescents
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      This study examines the impact of a group cognitive behavioral program aimed at preventing
      depressive disorders and symptoms in adolescents at risk for developing depression.
    

Detailed description: 
      Depression is a prevalent, chronic, and impairing condition that is often undetected and
      becomes more difficult to treat as chronicity increases. There is an increasing need to
      conduct large-scale depression prevention studies in adolescents. This study evaluates a
      cognitive-behavioral prevention (CBP) program to determine its effectiveness in preventing
      depressive disorders in at-risk adolescents. The study also will ascertain the costs this
      intervention to inform attempts at future dissemination of the program in "real world"
      settings.

      Participants in this study are randomly assigned to receive either CBP for eight weekly and 6
      monthly continuation sessions or usual care. Depressive symptoms and disorders, levels of
      functioning, and medical and mental health care utilization are assessed at baseline and
      again at 2, 8, 20, and 32 months after intake.
    

Intervention name(s): Cognitive-behavioral prevention program; Usual care
Intervention type(s): Behavioral; Other
Intervention description(s): Cognitive-behavioral prevention program includes 8 weekly and 6 monthly group sessions.; Participants receive usual care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Adolescent
Oocyte Vitrification Aided With Cytochalasin B
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      Using the cytoskeleton Stabilizer the Cytochalasin B would improve the outcome of oocyte
      vitrification.
    


Intervention name(s): Cytochalasin B supplemented vitrification medium
Intervention type(s): Other
Intervention description(s): Vitrification of human oocyte in medium supplemented with Cytochalasin B
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other