bioihbjkbjnl/mcl2 huggingface dataset:
Pemetrexed Disodium and Gemcitabine in Treating Patients With Advanced Cancer of the Urothelium
Condition: Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer
MeSH terms: Urinary Bladder Neoplasms; Urethral Neoplasms; Carcinoma, Transitional Cell; Kidney Neoplasms; Ureteral Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes
      necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in
      different ways to stop tumor cells from dividing so they stop growing or die. Combining
      pemetrexed disodium with gemcitabine may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combining pemetrexed disodium with
      gemcitabine in treating patients who have advanced cancer of the urothelium.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the response rate in patients with previously untreated advanced cancer of the
           urothelium treated with pemetrexed disodium and gemcitabine.

        -  Determine the toxicity of this regimen in these patients.

      Secondary

        -  Determine the overall survival and time to progression in patients treated with this
           regimen.

      OUTLINE: This is a multicenter study.

      Patients receive pemetrexed disodium IV over 10 minutes on day 1 and gemcitabine IV over 30
      minutes on days 1 and 8. Patients also receive cyanocobalamin intramuscularly once every 9
      weeks and folic acid orally once daily beginning on day -6 and continuing until 3 weeks after
      the completion of study therapy. Treatment repeats every 3 weeks for up to 6 courses in the
      absence of disease progression or unacceptable toxicity.

      Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

      PROJECTED ACCRUAL: A total of 24-46 patients will be accrued for this study within 15 -18
      months.
    

Intervention name(s): gemcitabine hydrochloride; pemetrexed disodium
Intervention type(s): Drug; Drug
Intervention MeSH terms: Gemcitabine; Pemetrexed
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metastatic transitional cell cancer of the renal pelvis and ureter; recurrent transitional cell cancer of the renal pelvis and ureter; regional transitional cell cancer of the renal pelvis and ureter; transitional cell carcinoma of the bladder; recurrent bladder cancer; stage III bladder cancer; stage IV bladder cancer; anterior urethral cancer; posterior urethral cancer; recurrent urethral cancer; urethral cancer associated with invasive bladder cancer
Impact of iMRI on the Extent of Resection in Patients With Newly Diagnosed Glioblastomas
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional

Summary: 
      Standard treatment of glioblastomas (GBMs) consists of microsurgical resection followed by
      concomitant chemoradiation. The extent of resection is one of the most important prognostic
      factors with significant influence on the survival of patients. State of the art technique to
      achieve the most radical resection possible in conventional surgery is fluorescence-guidance
      with 5-aminolevulinic acid (5-ALA). If available, intraoperative MRI (iMRI)-guided tumor
      resection enables an intraoperative resection control and subsequent continuation of surgery
      if contrast enhancing tumor remnants are found. Therefore a more radical resection and longer
      survival of patients might be possible. To date no comparison of these two leading
      technologies for GBM-surgery is available to identify the best surgical therapy of this fatal
      disease and to justify significant healthcare-economic differences between both technologies.

      Goal of this study is to assess the value of iMRI guidance in the resection of GBMs in
      comparison to conventional 5-ALA microsurgery. Primary endpoint is the number of total
      resections (no residual contrast enhancement) in the postoperative MRI (T1+CM within 48 hours
      after surgery) in each group. Secondary endpoints are perioperative clinical data,
      progression free survival, patients' clinical condition and overall survival.

      The study design was chosen to be a parallel-group approach to compare iMRI and 5-ALA centers
      (n=13) to exclude possible bias which might be found by randomizing patients within
      individual iMRI centers and to have surgeons with the most experience possible in use of each
      respective technology.
    


Intervention name(s): iMRI-guided surgery; 5-ALA-guided surgery
Intervention type(s): Device; Drug
Intervention description(s): For iMRI-guided glioma resections the surgery can be paused and a direct intraoperative resection control is possible by performing an intraoperative MRI scan. If residual tumor is found, the resection might be continued.; For 5-ALA guided glioma resections patients have to drink 100ml of a solution with 5-Aminolevulinic acid 4-6 hours before surgery. Intraoperatively the light source of the surgical microscope can be switched to a certain wave length to enable fluorescence of the glioma cells, which helps resecting the tumor as radical as possible.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: 5-ALA; Intraoperative MRI; Extent of resection
Interrelations Between Spontaneous Otoacoustic Emissions and Transient Evoked Emissions
Condition: Cochlear Function
Study type: Observational

Summary: 
      To verify the occurrence of Spontaneous Otoacoustic Emissions (SOAE) in neonates at term and
      preterm infants who had transient otoacoustic emissions and verify if the presence of
      response is related to gestational age, gender or risk factors for hearing loss.
    


Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Children born in this institution
      
Keywords: otoacoustic emissions in newborns
Displaced Proximal Humeral Fractures: Delta Prothesis or Philos Plate?
Condition: Proximal Humeral Fractures, AO/OTA (2007) Group B2 and C2
MeSH terms: Fractures, Bone; Humeral Fractures; Shoulder Fractures
Study type: Interventional

Summary: 
      To investigate the assumption that reversed shoulder prosthetic replacement will give a
      better functional outcome compared to open reduction and internal fixation with an angular
      stable plate in displaced proximal humeral fractures. Short name: The DelPhi trial.
    

Detailed description: 
      Reversed total shoulder artroplasty (RTSA) equals Delta Xtend reversed total shoulder
      prosthesis.

      Angular stable plate means Proximal humerus plate (Philos)
    

Intervention name(s): Reverse total shoulder arthroplasty
Intervention type(s): Device
Other intervention name(s): Delta Xtend shoulder proshesis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Reversed prosthesis, Philos, Severe displaced
Expand Your Horizon: An Online Writing Intervention for Women
Condition: Body Image
Study type: Interventional

Summary: 
      The purpose of this research study is to test a new writing-based intervention that helps
      young adult women increase their body acceptance and fosters creativity.
    

Detailed description: 
      In this study, participants will be asked to do the following things:

        1. Complete 3 writing exercises over the course of week. Each writing exercise will take
           approximately 15 minutes to complete

        2. ~1-hour long online surveys immediately after the program (1 week), and 1 week after the
           program. Questions will ask about eating behaviors and attitudes, body image, feelings
           of weight stigma, and mental health.

        3. Be contacted through email to remind participants to complete the writing
           assignments/survey
    

Intervention name(s): body acceptance program; writing creatively program
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Complete 3 writing exercises over the course of week. Each writing exercise will take approximately 15 minutes to complete; Complete 3 writing exercises over the course of week. Each writing exercise will take approximately 15 minutes to complete
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Pharmacokinetic Interaction Between Kaletra® (LPV/r) and BILR 355 BS Plus Ritonavir in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the pharmacokinetic effect of BILR 355 BS on Kaletra® and of Kaletra® on BILR
      355 BS
    


Intervention name(s): BILR 355 BS; Ritonavir (RTV); Kaletra®
Intervention type(s): Drug; Drug; Drug
Intervention description(s): NORVIR®; (lopinavir (LPV) and ritonavir (RTV))
Intervention MeSH terms: Ritonavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Effectiveness of Tenofovir Disoproxil Fumarate (Tenofovir DF) Plus Other Anti-HIV Drugs in HIV-Infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to see if giving tenofovir DF plus a combination of other
      anti-HIV drugs is safe and effective.
    

Detailed description: 
      Patients are randomized 2:1 to add tenofovir DF once daily or placebo to their existing
      antiretroviral regimen in a blinded manner. Patients are stratified according to HIV-1 RNA
      level, CD4 cell count, and number of antiretroviral drugs taken prior to study entry.
      Patients and physicians are strongly discouraged from making changes in their antiviral
      therapies for at least 24 weeks post-randomization. After Week 24, changes in background
      antiretroviral therapy are permitted. At 24 weeks post-randomization, patients randomized to
      receive placebo are crossed over to receive open-label tenofovir DF once daily for the
      remainder of the 48-week study. While on study drug, patients are monitored for safety using
      periodic physical examinations and serial laboratory tests. Additionally, changes in plasma
      HIV RNA levels and CD4 cell counts are monitored to assess antiviral efficacy. At the end of
      the 48-week study period, patients are rolled over into extended dosing until tenofovir DF is
      commercially available or Gilead Sciences terminates the study.
    

Intervention name(s): Tenofovir disoproxil fumarate
Intervention type(s): Drug
Intervention MeSH terms: Tenofovir
Masking: Double
Primary purpose: Treatment
Keywords: HIV-1; Drug Therapy, Combination; Drug Administration Schedule; RNA, Viral; Anti-HIV Agents; Viral Load
Yohimbine to Enhance Cognitive Behavioral Therapy (CBT) for Social Anxiety
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the utility of Yohimbine hydrochloride for
      facilitating fear extinction in a sample of patients with social phobia who will be treated
      with CBT.
    

Detailed description: 
      The primary aim is to determine the relative efficacy of exposure-based CBT for social phobia
      when conducted with adjunctive acute (prior to four of five sessions) administration of
      either Yohimbine hydrochloride (10.8 mg) or placebo during core exposure sessions. Based on
      the available evidence, the investigators hypothesize that acute treatment with Yohimbine
      hydrochloride prior to exposure-based CBT would facilitate the extinction of fear that occurs
      with this treatment and would enhance treatment outcome.
    

Intervention name(s): Group Cognitive Behavioral Therapy; Yohimbine Hydrochloride; Sugar Pill
Intervention type(s): Behavioral; Drug; Drug
Intervention description(s): 5 weeks of group CBT for Social Anxiety. The aim of CBT is to help participants become more comfortable with social situations
One arm will receive placebo augmented Group Cognitive Behavioral Therapy and the other will receive yohimbine hydrochloride augmented cognitive behavioral therapy.; Participants in the Yohimbine augmented arm will receive 4 doses of Yohimbine Hydrochloride before 4 of the 5 group cognitive behavioral therapy sessions.; Participants in the placebo (sugar pill) augmented arm will receive 4 doses of a sugar pill before 4 of the 5 group cognitive behavioral therapy sessions.
Intervention MeSH terms: Yohimbine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Energy Expenditure of High Intensity Functional Training
Condition: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to assess the energy expenditure and intensity of a High
      Intensity Functional Training (HIFT) session in overweight and obese adult men and women.
    

Detailed description: 
      High Intensity Functional Training (HIFT), which alternates short periods of intense exercise
      using varied, multiple-joint movements, with less-intense active recovery periods, may offer
      an attractive, time efficient alternative to traditional aerobic exercise. Variations of HIFT
      such as Cross Fit, home workout videos (ie.P90x and Insanity), and boot-camp style group
      exercise classes have become increasingly popular.

      The cardiovascular benefits of HIFT have been demonstrated; however, by doing this study
      researchers hope to get more information regarding the potential effectiveness of HIFT for
      weight management, such as the actual level of energy expenditure and exercise intensity
      elicited by a HIFT session.
    

Intervention name(s): HIFT
Intervention type(s): Other
Intervention description(s): Workout alternates short periods of intense exercise using varied, multiple-joint movements, with less-intense active recovery periods. Workout sessions will be led by a trained instructor.
Other intervention name(s): High Intensity Functional Training
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effects of a Rehabilitation Program on Immune Activation and Mood in Heart Failure Patients
Condition: Heart Failure; Depressive Symptoms
MeSH terms: Heart Failure; Depression
Study type: Observational

Summary: 
      The aim of this descriptive study is to examine potential changes regarding inflammatory
      cytokine levels, depressive symptoms and quality of life over the course of the 4-week
      inpatient rehabilitation program which includes a cassette of modalities including
      counseling, psychosocial education and supervised exercise training as a main pillar, and to
      further investigate if there are correlations between changes in immune regulation,
      depressive symptoms and quality of life.
    


Intervention name(s): multi-modality rehabilitation program for heart failure
Intervention type(s): Behavioral
Intervention description(s): rehabilitation consists of supervised exercise training, both endurance and strength, as well as gymnastics, diet and psychosocial education around living with heart failure
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Heart failure patients, EF ≤ 45%, NYHA I - III; ACC/AHA stage C
      
Biospecimen description: 
      serum
Efficacy and Adverse Effects of Prapchompoothaweep Remedy and Loratadine for Treatment in AR Patients
Condition: Allergic Rhinitis; Adverse Drug Event; Quality of Life
MeSH terms: Rhinitis; Rhinitis, Allergic; Drug-Related Side Effects and Adverse Reactions
Study type: Interventional
Phase: Phase 2

Summary: 
      1. To compare the effectiveness of Prapchompoothaweep crude drug at 3,000 mg per day and
           Loratadine 10 mg per day for treatment in Allergic Rhinitis patients. (Clinical Trial
           Phase II)

        2. To evaluate the safety and adverse effect of Prapchompoothaweep crude drug at 3,000 mg
           and Loratadine 10 mg for Allergic Rhinitis patients.
    

Detailed description: 
      this study is a double blind randomized controlled trial study.

      the volunteers will be divided into 2 groups. One is received Prapchompoothaweep crude drug
      capsule at 1,000 mg 3 times a day before meals and the other is received Loratadine 10 mg per
      day before meals. it takes 6 weeks to complete the project for each volunteers.

      Before enrolling, volunteers will stop using any anti-histamine drug for 1 week (wash-out
      period). All volunteers will be followed up in the 3rd and 6th week to evaluate the efficacy
      and adverse effect after received drugs.

      The researcher will record characteristic data such as gender, age, BMI, vital signs and
      symptoms . The adverse effect will be monitored by hematology test e.g. liver function test,
      renal function test, lipid profile and blood sugar test.
    

Intervention name(s): Prapchompoothaweep remedy; Loratadine 10 Mg
Intervention type(s): Drug; Drug
Intervention description(s): Take Prapchompoothaweep remedy capsule at 1,000 mg for 3 times a day before meals.; Take Loratadine 10 mg once a day before meals.
Intervention MeSH terms: Loratadine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: this study is a double blind randomized controlled trial study. the volunteers will be divided into 2 groups. One is received Prapchompoothaweep crude drug capsule at 1,000 mg 3 times a day before meals and the other is received Loratadine 10 mg per day before meals. it takes 6 weeks to complete the project for each volunteers.
Before enrolling, volunteers will stop using any anti-histamine drug for 1 week (wash-out period). All volunteers will be followed up in the 3rd and 6th week to evaluate the efficacy and adverse effect after received drugs.
The researcher will record characteristic data such as gender, age, BMI, vital signs and symptoms . The adverse effect will be monitored by hematology test e.g. liver function test, renal function test, lipid profile and blood sugar test.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Loratadine; Prapchompoothaweep; Allergic rhinitis
Duckweed Intake Study
Condition: Gastrointestinal Complication
Study type: Interventional

Summary: 
      The study aims to study the impact of frequent intake of 150-180 gram duckweed on
      gastrointestinal complaints and several other health related biomarkers. The study has a
      randomised parallel design. Two different treatments will be evaluated e.g. a 11-day
      intervention with duckweed based meals and a 11-day intervention with control/spinach meals.
      At the start and at the end of the intervention we will collect a blood sample and a urine
      samples. Questionnaires about gut complaints, stool consistency and frequency, wellbeing,
      health complaints or other adverse effects will be collected daily during intervention and up
      to two days after the intervention.
    

Detailed description: 
      The study aims to study the impact of frequent intake of 150-180 gram duckweed on
      gastrointestinal complaints and several other health related biomarkers.

      Objective: The primary objective is to investigate gastro-intestinal complaints during 11 day
      duckweed consumption. Secondary objectives are to assess blood based parameters related to
      general health and urine based biomarkers for kidney function and to investigate consumer
      acceptance.

      Study design: The study has a randomised parallel design. Two different treatments will be
      evaluated e.g. a 11-day intervention with duckweed based meals and a 11-day intervention with
      control/spinach meals. At the start and at the end of the intervention we will collect a
      blood sample and a urine samples. Questionnaires about gut complaints, stool consistency and
      frequency, wellbeing, health complaints or other adverse effects will be collected daily
      during intervention and up to two days after the intervention.

      Study population: We aim to include 24 healthy volunteers aged 18-50 years. Intervention: A
      11-day intervention in which subjects will receive a daily lunch with 150-180g wet weight
      duck weed or spinach. Products will be incorporated in food products such as pasta, curry,
      soup etc.

      Main study parameters/endpoints: The main study parameter is frequency and severity of
      gastro-intestinal complaints. Secondary outcomes are intestinal health parameters derived
      from blood and urine samples taken before and after the intervention.
    

Intervention name(s): Duckweed; Spinach
Intervention type(s): Other; Other
Intervention description(s): various meal products such as meal soup, quiche, mashed potato, curry and pasta sauce; various meal products such as meal soup, quiche, mashed potato, curry and pasta sauce
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Improvement of Migraine Severity and Frequency With Migraineguard ™
Condition: Migraine; Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional

Summary: 
      Numerous treatments have been recommended for the prevention of migraine. The purpose of this
      randomized double-blind placebo controlled trial was to assess the efficacy of MIGRAINEGUARD
      ™ supplement by Herbacure Natural containing a combination of COQ10 , magnesium, riboflavin
      ,feverfew , Skullcap and black pepper as prophylactic treatment for migraine.
    

Detailed description: 
      Our team will assess MIGRAINEGUARD ™ , a migraine prevention supplement marketed Herbacure
      Natural for individual suffering from multiple migraine attacks in one month . The purpose of
      this 7-months , randomized, double-blind, placebo controlled study is to evaluate the
      efficacy and safety of MIGRAINEGUARD ™ produced by Herbacure Natural , A Canadian company
      based in Vancouver , BC , in reducing migraine headache severity and frequency of attacks
      compared to placebo when used every day, as a preventative solution for migraine and to
      assess and monitor the safety of its usage for adverse effects.

      The primary end-point is the severity and the frequency reduction of migraine attacks. The
      secondary end-points will be the existence of adverse reaction.
    

Intervention name(s): Migraineguard
Intervention type(s): Dietary Supplement
Intervention description(s): 2 Capsules per day for 7 Months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: migraine; headache