bioihbjkbjnl/mcl2 huggingface dataset:
Surgical Pain After Inguinal Hernia Repair (SPAIHR)
Condition: Pain, Postoperative; Hernia, Inguinal
MeSH terms: Hernia; Pain, Postoperative; Hernia, Inguinal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test whether pregabalin added to the standard of care with
      dosing starting preoperatively and continuing for 1 week post surgery will decrease the
      intensity of acute post-operative pain following inguinal hernia repair.
    


Intervention name(s): Pregabalin; placebo; Pregabalin; Pregabalin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 150 mg BID; Placebo; 75 mg BID; 25 mg BID
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: postoperative pain chronic pain
Efficacy and Safety of DKM420 in Patients With Osteoarthritis of Knee
Condition: Osteoarthritis of Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      To prove the non-inferiority of DKM420 by evaluating the injecting efficacy and safety DKM
      420 and control for patients who have osteoarthritis of Knee.
    

Detailed description: 
      A multi-center, randomized, double-blind, active-controlled, pivotal, non-inferiority
      clinical study
    

Intervention name(s): DKM420; Conjuran
Intervention type(s): Device; Device
Intervention description(s): A total of 3 doses will be applied at a dose of 2 mL over 3 weeks.; A total of 3 doses will be applied at a dose of 2 mL over 3 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 1:1 Parallel.
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Effects of Filter Ventilation on Sensory Response, Smoking Topography, and Inhalation in Current Every Day Cigarette Smokers
Condition: Cigarette Smoker; Current Every Day Smoker
MeSH terms: Respiratory Aspiration
Study type: Observational

Summary: 
      This trial examines the effects of filter ventilation on sensory response, smoking
      topography, and inhalation in current every day cigarette smokers. The physical design
      features of cigarettes directly impact their appeal by influencing cognitive and sensory
      perceptions. The introduction of a now common design feature, filter ventilation, has led to
      greater public harm than benefit because of the potential for greater toxicity while
      enhancing product appeal among smokers. Ventilated cigarettes dilute smoke, which promotes
      perceptions of ?smoothness? and therefore lower health risk, contributing to the overall
      appeal of these products. The purpose of this study is to assess whether removing ventilation
      from cigarette filters lowers cigarette product appeal among smokers.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To assess the link between marketing proxies for filter ventilation (product descriptors,
      packaging) and risk beliefs.

      OUTLINE:

      Patients smoke 5 cigarettes separated by 30 minute washout periods. Between 48 hours and 1
      week later, patients smoke another 5 cigarettes separated by 30 minute washout period with
      CReSSMicro topography measurement device and BioRadio device for recording inhalation
      patterns.
    

Intervention name(s): Medical Device; Questionnaire Administration; Tobacco Smoking
Intervention type(s): Device; Other; Behavioral
Intervention description(s): Smoke cigarettes with CReSSMicro topography measurement device and BioRadio device; Ancillary studies; Smoke cigarettes
Other intervention name(s): Device; Medical Devices; Smoking
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients currently smoking daily at least 5 cigarettes per day for at least one year
Immunogenicity and Safety of Pentaxim as 3 Doses Primary Vaccination Followed by a Booster Dose at 18 Months
Condition: Diphtheria; Tetanus; Haemophilus Influenzae Type b; Pertussis; Poliomyelitis
MeSH terms: Whooping Cough; Tetanus; Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 3

Summary: 
      As per request by the Heath Authorities, the present clinical study will assess the
      immunogenicity and safety of sanofi pasteur's DTacP-IPV// PRP~T combined vaccine (PENTAXIM™)
      as a three-dose primary vaccination at 2, 3, and 4 months of age or 3, 4 and 5 months of age
      followed by a booster dose at 18-20 months of age as compared to commercially available
      DTacP, Hib conjugate (Act-HIB™) and IPV (IMOVAX Polio™) monovalent vaccines in order to meet
      the requirements for registration of the product in People's Republic of China.
    


Intervention name(s): Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib; Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib; Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL, IM; 0.5 mL, IM; 0.5 mL, IM
Other intervention name(s): PENTAXIM™; PENTAXIM™; DTacP, Act-HIB™ and IMOVAX Polio™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Diphteria; Tetanus; Haemophilus influenzae type b; Poliomyelitis; Pertussis
Efficacy of a Gamified Augmented Reality Exposure-based Application in Subjects With Fear of Spiders
Condition: Fear of Spiders
MeSH terms: Phobic Disorders
Study type: Interventional

Summary: 
      Investigation of the efficacy of a gamified augmented reality exposure app in individual with
      fear of spiders.
    

Detailed description: 
      The study will be conducted as a randomized controlled between subject trial. The study
      consists of two visits and a home training for one group. 60 participants between 18 and 40
      years with clinical or subclinical fear of spiders will take part in the study.

      All assessments of outcome will be conducted on one visit for each participant, including an
      in vivo BAT. The experimental group will participate in a home training with the app,
      spanning over two weeks (6x30-minutes sessions), whereas the control group will not receive
      any treatment (untreated comparison group).

      Six weeks after the first visit all participants undergo the assessments of outcome,
      including a second in vivo BAT. The BAT will take place 4 weeks after completion of the home
      training. This design allows a direct comparison and therefore an estimation of the efficacy
      of the gamified AR exposure therapy.
    

Intervention name(s): AR app
Intervention type(s): Other
Intervention description(s): Participants will be exposed to nine different AR spider scenarios with a pre-defined length of 2 minutes for each level. Each level starts with a surface scan of the environment and the placement of the AR spider model(s) by tapping on the display. Through small text pop-ups the user is instructed to perform different tasks (e.g. looking at the spider model, approaching it, holding the hand under the model). They proceed to further levels according to a predefined exposure scheme based on SUDS for fear (scale 0=no fear to 10=maximum fear) and disgust (scale 0=no disgust to 10=maximum disgust) and the assurance of the task completed (yes/no). Users will repeat each level until their SUDS are 4 or below and have completed the task. Each exposure session is limited to approx. 30 minutes (controlled by the participants) irrespective of achieved level.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled single-blind study design
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Comparing Quetiapine XR Monotherapy and Augmentation With Lithium Augmentation in TRD Patients
Condition: Major Depressive Disorder; Treatment Resistant Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to evaluate the efficacy of Quetiapine extended release
      (XR) in combination with an selective serotonin reuptake inhibitor (SSRI) or Venlafaxine
      versus Lithium in combination with an selective serotonin reuptake inhibitor or Venlafaxine
      versus Quetiapine extended release monotherapy in subjects with treatment resistant
      depression as assessed by the changes from randomisation to week 6 in the Montgomery-Åsberg
      Depression Rating Scale (MADRS) total score. As an independent objective, the primary
      objective will also be evaluated in two subgroups of patients: (1) patients who were
      resistant to two previous antidepressant therapies and (2) in the subgroup of patients with
      one previous failure.
    

Detailed description: 
      The secondary objectives of the study are to compare the effects of the three different
      treatment regimen as assessed by the following variables and, if applicable, by their changes
      from randomisation to week 6 (end of study). Additionally the time of onset of therapeutic
      effect will be assessed by evaluating efficacy data after the first four days (Day 4) of
      treatment as well as after the first week of treatment (Day 8). These analyses will also be
      performed in the subgroups of patients with 2 failed previous antidepressants and patients
      with 1 failure.
    

Intervention name(s): Quetiapine XR; Lithium carbonate; SSRI/Venlafaxine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 300 mg once daily (od); 900 mg once daily (od); SSRI - doses within label, Venlafaxine dose up to 225 mg/day
Other intervention name(s): Seroquel XR; Quilonum Retard
Intervention MeSH terms: Quetiapine Fumarate; Lithium Carbonate; Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression; MDD; TRD
Effect of Electroconvulsive Therapy (ECT) and Transcranial Magnetic Stimulation(TMS) on Brain Derived Neurotrophic Factor (BDNF) in Depressed Patients.
Condition: Depression
MeSH terms: Depression
Study type: Observational

Summary: 
      To investigate the change in brain derived neurotrophic factor (BDNF) between pre and post
      treatment for patients with depression with either ECT or TMS.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults patients with current major depressive disorder or bipolar depression who are to
        receive either ECT or TMS.
      
Biospecimen description: 
      serum frozen
Gemcitabine Plus Rapamycin Versus Gemcitabine to Treat Advanced Soft Tissue Sarcoma
Condition: Advanced Soft Tissue Sarcoma
MeSH terms: Sarcoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The soft tissue sarcomas (STS) constitute an infrequent group of malignant neoplasms of
      mesenchymal origin. In Spain, the approximate incidence is of 2 new cases per 100.000
      inhabitants every year. In patients with metastatic STS, the average survival is very short,
      approximately 12 months. The systemic treatment of the metastatic disease has had a very
      limited development, with few satisfactory results. This facts reflect the urgent need to
      identify new active agents for treatment of these patients.

      The molecular pathway of the serine/threonine kinase mammalian target of rapamycin (mTOR)
      plays a central role in the regulation of the proteins translation, cellular growth and
      metabolism (Meric-Bernstam F et al. 2009). Currently, the mTOR pathway is considered a
      relevant target for the development of anti-cancer drugs, as rapamycin. Preliminary results
      of some clinical trials suggest that mTOR inhibitors could have some clinical activity for
      different types of sarcoma, including STS (Chawla et al Proc.ASCO 2006; Schuetze et al.
      Proc.ASCO 2006).

      Gemcitabine is a chemotherapy antimetabolite agent with a broad antitumoral spectrum. The
      activity of this drug to treat resistant sarcomas and its reduced toxicity make from
      gemcitabine an adequate candidate for its study in combination with new drugs addressed to
      molecular targets in the STS treatment.

      Pre-clinical studies suggest that mTOR inhibitors could have a potential synergistic or
      additive effect with some chemotherapy agents. The combination of rapamycin and gemcitabine
      seems to be a reasonable strategy to explore for the STS treatment.
    


Intervention name(s): Gemcitabine + Rapamycin
Intervention type(s): Drug
Intervention description(s): Gemcitabine + rapamycin at recommended dose of Phase 1. Recommended dose is defined as, the dose one level below of the (MTD). Being MTD, the dose of the cohort in which a maximum of one patient of 6 has presented dose-limiting toxicity (DLT).
Every three weeks until disease progression or unacceptable toxicity. The treatment will last for 6 cycles if there is not progression or intolerable toxicity.
Additionally, there will be a pharmacokinetic study in a minimum of 9 patients treated with the drug combination.
Intervention MeSH terms: Sirolimus; Gemcitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Soft tissue sarcoma; Gemcitabine; Rapamycin; Sirolimus; mTOR inhibitor; Molecular biomarkers
Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Narcolepsy Type 1
Condition: Narcolepsy Type 1; Fmri
MeSH terms: Narcolepsy
Study type: Interventional

Summary: 
      The study aimed to examine the efficacy and safety of tVNS as a complementary approach for
      NT1 by conducting a double-blind, randomized, sham-controlled trial. The specific objectives
      of the study were as follows: To evaluate the effects of complementary tVNS on the ability to
      maintain wakefulness, severity of narcolepsy, mood and quality of life in patients with NT1
    


Intervention name(s): transcutaneous auricular vagus nerve stimulation
Intervention type(s): Device
Intervention description(s): Transcutaneous auricular vagus nerve stimulation (tVNS) is a newly developed treatment for neuromodulation. It offers advantages such as being non-invasive, cost-effective, and not requiring battery changes, unlike invasive vagus nerve stimulation (iVNS). The auricular branch of the vagus nerve, which is the only afferent branch distributed on the surface of the human body, can be directly stimulated to produce effects similar to classic vagus nerve stimulation (VNS)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: transcutaneous auricular vagus nerve stimulation
Common Bile Duct Pressure After Surgical Exploration
Condition: Choledocholithiasis
MeSH terms: Choledocholithiasis
Study type: Interventional

Summary: 
      A study that included patients of any gender between 15 and 70 years, with the diagnosis of
      choledocholithiasis who required a cholecystectomy with an exploration of bile ducts.
      Conventional cholecystectomy was performed and a T-tube was inserted in the common bile duct
      (CBD) to measure the intraluminal pressure immediately after the procedure, and weekly
      thereafter, with a 6-week follow-up. A control T-tube radiological study was performed at six
      weeks to exclude residual stones.
    

Detailed description: 
      A clinical, controlled, prospective, longitudinal, descriptive, observational and
      double-blinded study was designed. Patients of any gender between 15 and 70 years, with a
      diagnosis of choledocholithiasis, and who required a cholecystectomy with an exploration of
      bile ducts were included. Conventional cholecystectomy was performed and perioperative T-tube
      CBD pressure was registered immediately after the procedure, and weekly thereafter, with a
      6-week follow-up.

      Control T-tube cholangiogram was performed at six weeks to exclude residual stones. Data was
      analyzed with T-test for parametric values.
    

Intervention name(s): Cholecystectomy and common bile duct exploration
Intervention type(s): Procedure
Intervention description(s): During elective open cholecystectomy, a basal commcn dile duct (CBD) manometry was obtained immediately after cholecystectomy, with a 10 Fr. silicone T tube introduced into the cystic duct and connected to a glass manometer.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Choledocholithiasis; common bile duct; cholangiogram.
Efficacy of Dolasetron in Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      This study offers a new treatment, dolasetron or ANZEMET ®, which will be administered by
      intravenous way once a day during a 4 days Hospitalization.

      This study is double blind (neither you nor the physician will know if you are receiving
      active study drug or placebo).

      Randomisation at the beginning of the study will decide whether you receive active treatment
      or its placebo.

      This treatment will be renewed after one month, after 2 months and after 3 months.

      If the study staff determines that you are eligible and you decide to participate, there will
      be approximately 6 study visits in about 9 months. During these visits, you will undergo
      routine health exams and complete different kinds of questionnaires.

      Following this first period of 3 months, you agree to come back for consultation at month 4,
      month 6 and month 12 for monitoring and evaluating the effects of treatment.
    


Intervention name(s): Dolasetron; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive dolasetron at a dose of 12.5 mg / day for 4 days at J0, M1, M2 and M3; Patients will receive placebo everyday for 4 days at J0, M1, M2 and M3
Intervention MeSH terms: Dolasetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Exercise Training in Patients With Coronary Heart Disease and Type 2 Diabetes
Condition: Coronary Artery Disease; Diabetes Mellitus, Type 2; Atherosclerosis
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Atherosclerosis; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Diabetes mellitus (DM) is an important risk factor in the development of cardiovascular
      disease, and people with type 2 diabetes have a two- to four-fold increased risk for
      cardiovascular morbidity and mortality. Physical activity is a well established therapeutic
      modality for type 2 diabetes. In patients with coronary artery disease (CAD), several
      clinical trials have shown reduced mortality and reduced progression of atherosclerosis with
      lifestyle intervention including physical activity. But few studies have investigated the
      effect of physical training in patients suffering from both diseases.

      The aim of this study is to investigate the effect of one year of organized physical exercise
      in patients with both coronary heart disease and type 2 diabetes on glucometabolic state and
      progression of atherosclerosis.

      The project is a randomized, controlled, open study on physical exercise. 136 patients will
      be randomized at inclusion to a physical exercise group or a control group, the latter with
      "normal" follow-up and not discouraged form physical activity. The intervention period will
      be 12 months, and the physical training program will be developed and conducted in
      collaboration with Norwegian School of Sport Sciences. The inclusion of patients started
      summer 2010, the exercise program begins in September 2010 and the practical issues of the
      study is planned to end during spring 2012.

      The main hypothesis is that physical exercise improves the glucometabolic state and reduces
      progression of atherosclerosis in patients with coronary heart disease and type 2 diabetes,
      and secondary that physical exercise induces favourable changes in cardiovascular risk
      factors, use of medication, and co-morbidity associated with diabetes.
    


Intervention name(s): Exercise
Intervention type(s): Behavioral
Intervention description(s): 12 months of exercise training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coronary Artery Disease; Atherosclerosis.; Diabetes Mellitus, type 2; Exercise; HbA1c; Carotid Atherosclerotic Disease; Inflammation
Pilot Study in Young Adults to Examine the Kinetics of Changes in the B-cell Repertoire Following TIV Immunization
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose is to investigate B-cell response to the trivalent Influenza Vaccine (TIV) in
      healthy young adults by vaccinating participants and obtaining blood samples at designated
      time points before and after vaccination.
    

Detailed description: 
      This is an exploratory study using a strategy that has not been previously employed to
      investigate B-cell responses. Investigators will collect blood samples from the volunteers at
      a higher frequency than in the two previous flu seasons to better define the dynamic response
      to vaccination. The objective is to compare the Ig gene repertoire before and after
      vaccination by deep sequencing PBMC and proteomic analysis of antibody CDR3 regions at 10
      different time points before and after immunization.

      This is a Phase IV study of healthy adults who are given standard TIV off-season. There are
      no exclusions for gender, ethnicity or race. Following confirmation of written informed
      consent, baseline blood samples will be drawn from all study participants at Day -5, Day -3
      and Day 0 prior to immunization, and at Days 1, 4, 7, 9, 11, 28 and 180 post-immunization.
      Volunteers will be vaccine-naïve for the 2010-2011 and 2011-2012 seasonal influenza vaccines.
      All participants will receive a single dose of the current seasonal influenza vaccine by
      intramuscular (IM) injection at Day 0.
    

Intervention name(s): 2011-2012 Fluzone IIV3 (IM)
Intervention type(s): Biological
Intervention description(s): 2011-2012 Fluzone IIV3 vaccine delivered intramuscularly (IM)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Influenza Vaccine