bioihbjkbjnl/mcl2 huggingface dataset:
Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer
Condition: Squamous Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of the addition of veliparib
      plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and
      paclitaxel in adults with advanced or metastatic squamous non-small cell lung cancer (NSCLC).
    


Intervention name(s): Carboplatin; Veliparib; Paclitaxel; Placebo to veliparib
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Carboplatin administered intravenously over approximately 15 to 30 minutes at (AUC 6 mg/mL/min) immediately following paclitaxel infusion.; Capsules taken orally twice a day, 12 hours apart.; Paclitaxel administered intravenously over 3 hours at a dose of 200 mg/m².; Capsules taken orally twice a day, 12 hours apart.
Other intervention name(s): ABT-888
Intervention MeSH terms: Paclitaxel; Carboplatin; Veliparib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: veliparib; carboplatin; paclitaxel; Poly Adenosine diphosphate (ADP)-ribose Polymerase (PARP); Overall Survival; Advanced; Metastatic; ABT-888; Squamous; Randomized; non-small cell lung cancer; placebo controlled
Magnetic Resonance Imaging in Women Recently Diagnosed With Unilateral Breast Cancer
Condition: Breast Cancer; Contralateral Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      RATIONALE: Diagnostic procedures such as magnetic resonance imaging (MRI) may improve the
      ability to detect cancer in the unaffected breast of women recently diagnosed with unilateral
      breast cancer.

      PURPOSE: Diagnostic trial to determine the effectiveness of MRI in evaluating the unaffected
      breast of women recently diagnosed with unilateral breast cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the diagnostic yield of magnetic resonance imaging (MRI) in evaluating the
           contralateral breast of women with a recent unilateral diagnosis of breast cancer and a
           negative contralateral mammogram and clinical breast exam.

        -  Determine the sensitivity, specificity, positive predictive value for both call backs
           for additional imaging and biopsy recommendations, and receiver operating characteristic
           curves of MRI in evaluating these patients.

        -  Determine the effect of the following patient-related factors: age (50 years old and
           over vs less than 50 years old), breast parenchymal density (fatty vs non fatty breast),
           and tumor histology (invasive lobular vs invasive ductal, invasive vs in situ) on the
           performance of MRI (cancer yield, sensitivity, specificity, and PPV).

      OUTLINE: This is a multicenter study.

      Patients receive gadopentetate dimeglumine IV and then undergo magnetic resonance imaging of
      the contralateral breast.

      Patients are followed at 12-18 and 24-30 months.

      PROJECTED ACCRUAL: A total of 1,000 patients will be accrued for this study.
    

Intervention name(s): MRI
Intervention type(s): Procedure
Intervention description(s): Breast contralateral to the breast diagnosed with cancer was scanned prior to initiation of chemotherapy and within 90 days of a negative mammogram of the study breast. A recent (within 90 days) negative or benign mammogram (defined by final BI RADS category 1 or 2) and negative or benign clinical breast exam of the study breast were required for entry into the study.
Other intervention name(s): magnetic resonance imaging
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: ductal breast carcinoma in situ; invasive ductal breast carcinoma; invasive lobular breast carcinoma; breast cancer in situ; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer; Magnetic resonance imaging; MRI
Intragastric Balloon in Compensated NASH(Non Alcoholic Steato Hepatitis) Cirrhotics
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Observational

Summary: 
      The study will be conducted in department of Hepatology at ILBS, the patients will be
      recruited from the OPD or IPD . The obese cirrhotic patients with NASH will be observed for
      standard of care and also patients who undergo IGB placement as part of weight reduction
      policy in these group of patients and will undergo an UGI endoscopy followed by placement of
      intragastric balloon. Then the patients will be admitted for 2-3 days and followed up till 6
      months.
    


Intervention name(s): Intragstric Ballooning
Intervention type(s): Procedure
Intervention description(s): Intragstric Ballooning will be put.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        NASH (Non Alcoholic SteatoHepatitis) cirrhosis.
IMX-150 Cream for Diabetic Neuropathy
Condition: Diabetic Peripheral Neuropathy
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the effectiveness of two different dose of IMX-150 to
      that of placebo (non-active) in the treatment of diabetic peripheral neuropathy pain of the
      feet.
    


Intervention name(s): IMX-150; IMX-150; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): (0.3%) 0.5g topically BID to each foot for 4 weeks; (0.6%) 0.5g topically BID to each foot for 4 weeks; 0.5 g topically BID to each foot for 4 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Foot Pain; Diabetic Neuropathy Pain; Diabetic Peripheral Neuropathy foot pain
Eosinophilic Esophagitis Databank
Condition: Esophagitis; Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Observational

Summary: 
      This study will establish a registry for participants with eosinophilic esophagitis (EoE) and
      create a research resource that will provide further insights into EoE.
    

Detailed description: 
      Eosinophilic esophagitis (EoE) is a newly recognized chronic disease that is increasingly
      being diagnosed in children and adults. Many patients with EoE also have food allergies. EoE
      is characterized by inflammation and accumulation of a specific type of immune cell, called
      an eosinophil, in the esophagus. While there have been several large studies of EoE, very few
      have focused on the roles the immune system, genetics/heredity, and the environment in EoE.

      The samples and information collected from participants will help to identify and understand
      the genetic mechanisms underlying eosinophilic esophagitis.

      The Cincinnati Children's Hospital Medical Center will serve as the Central Laboratory for
      genetic characterization studies.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Participants with biopsy proven Eosinophilic Esophagitis
      
Biospecimen description: 
      blood and saliva
    
Keywords: Eosinophilic Esophagitis
Effects of Ecological Rythmic-acoustic Stimulation (E-RAS) on Motor Skills in Individuals With Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The use of rhythmic auditory stimulation (RAS) has been proven useful in the management of
      gait disturbances induced by Parkinson's disease (PD). Typically, the stimuli used to provide
      RAS consist of metronome or music-based sounds, which are not related with the auditory
      experience of walking. Based on previous laboratory research, it is hypothesized that the use
      of ecological sounds deriving from biological motion (i.e., footstep sounds) could have a
      greater impact compared to artificial sounds (i.e., metronome sounds), within a
      rehabilitation program. In a double-blind experiment, it was investigated the effects of 5
      weeks of supervised rehabilitation integrated with RAS. Thirty-two individuals affected by PD
      (age 68.2 ± 10.5, Hoehn and Yahr 1,5-3) were randomly assigned to one of the two conditions
      (artificial vs. ecological sounds). Spatio-temporal parameters of gait and clinical variables
      were assessed before the rehabilitation period, at its end, and after a 3-month follow-up.
      The results revealed that the rehabilitation program integrated with RAS had positive effects
      on the majority of objective and subjective measures, independently of the type of sound.
      However, when the two groups were examined separately, the patients assigned to the
      ecological RAS condition were the only who improved both in terms of cadence and gait speed.
      Overall, the hypothesized greater effect of the ecological sounds compared to artificial
      sounds was only partially supported by data.
    


Intervention name(s): Administration of rhytmic acoustic stimuli for gait training
Intervention type(s): Other
Intervention description(s): The intervention consist in 5 weeks, 20 min/day gait training assisted by rhythmic acoustic stimuli administered using a portable MP3 player
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomly assigned to one of the two groups (artificial or ecological RAS) and were evaluated in three moments: before the rehabilitative treatment (T0), at the end of the 5 week rehabilitative treatment (T5), and 3 months after the end of the treatment, namely 17 weeks after the first assessment (T17).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rhythm; Ecological sounds; Auditory stimuli; rhythmic auditory stimulation; Parkinson's Disease; Gait; Gait analysis; Spatio-temporal parameters
Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment
Condition: Solid Tumours
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2-part study in patients with advanced solid tumours. Part A will investigate the
      PK of olaparib in patients with mild or moderate hepatic impairment compared to patients with
      normal hepatic function; Part B will allow patients with mild or moderate hepatic impairment
      or normal hepatic function continued access to olaparib after the PK phase and will provide
      additional safety data.
    


Intervention name(s): Olaparib tablet dosing
Intervention type(s): Drug
Intervention description(s): Part A - single 300mg oral dose olaparib (administered as 2x150mg tablets) Part B - 300mg oral dose olaparib (administered as 2x150mg tablets) bd
Intervention MeSH terms: Olaparib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: oncology,; cancer,; neoplasm,; anticancer drug,; pharmacokinetics,; area under curve,; olaparib,; solid tumour,; mild hepatic impairment,; moderate hepatic impairment
Non-Comparative Study to Assess the Efficacy and Safety of the New Food Supplement FaseMETS
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The primary objective is to evaluate the efficacy of FaseMETS for 6 consecutive months in
      lowering serum lipids and glucose in subjects with Metabolic Syndrome;

      The secondary objectives of the trial are:

        -  to evaluate the potential benefit after 3 months of therapy (by an interim analysis)

        -  to evaluate the safety of FaseMETS
    

Detailed description: 
      The trial is designed as a multicenter, open label, non-comparative, 6 months, pilot study.

      The primary objective is to evaluate the efficacy of FaseMetS ® administered for 6 months
      treatment combined with a health management plan in reducing the serum lipidemic profile
      (this includes total cholesterol, LDL cholesterol, HDL cholesterol, small density LDL
      particles, triglycerides, serum glucose, glycated haemoglobin (HBA1c), insulin, and
      pro-insulin, HOMA index, uric acid, body mass index (BMI), creatine phosphokinase) in
      patients diagnosed with Metabolic Syndrome and with mild to moderate Hypercholesterolemia.

      The secondary objectives are:

        -  to evaluate the efficacy in reducing the serum lipidemic profile after a period of 3
           months of FaseMetS ® ® treatment;

        -  to evaluate the safety of FaseMetS ® treatment by recording AE/SAE (with particular
           regards for gastrointestinal symptoms);

        -  improvement of blood clinical laboratory parameters;

        -  improvement of weight control systolic blood pressure and diastolic blood pressure
           control
    

Intervention name(s): Daily administration: 2 tablets FaseMETS a day
Intervention type(s): Dietary Supplement
Intervention description(s): Treatment with FaseMETS for 6 consecutive months in lowering serum lipids and glucose in subjects with Metabolic Syndrome
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Axillary Plexus Block in a High Resolution MRI
Condition: Nerve Block; Magnetic Resonance Imaging
Study type: Interventional
Phase: Phase 2

Summary: 
      Background and aims:

      Magnetic resonance imaging (MRI) has proved beneficial for presenting anatomy for regional
      anaesthesia and to demonstrate spread of local anaesthetic.

      A new axillary plexus block with a triple injection (1), combining a short axillary catheter
      method with a transarterial axillary block, is now being evaluated with a 3 Tesla MRI. In
      this study, the investigators are investigating MR visualisation of three different block
      techniques and compare the clinical efficacy of the techniques, with the MR findings.

      Patients & Methods:

      After obtaining approval of the protocol from the regional ethical committee, 3 x 15 adult
      patients, scheduled for hand surgery, were included in a randomised, blinded prospective
      study.
    

Detailed description: 
      After obtaining approval of the protocol from the regional ethical committee, 3 x 15 adult
      patients, scheduled for hand surgery, were included in a randomised, blinded prospective
      study.

      In all patients a short axillary plexus catheter is positioned close to the median nerve
      using nerve stimulator.

      Technique 1 = 40 ml in catheter Technique 2 = 30 ml behind and 10 ml in front of the brachial
      artery (BA) Technique 3 = 20 ml behind, 10ml in front of the BA and 10 ml in catheter

      Clinical High Field MRI (3T) scanner has simplified the recognition of brachial plexus nerves
      in the axilla. After injection of local anaesthetic (LA), the identification of the nerve
      structures is nevertheless difficult. When all nerves are surrounded of LA in the axilla
      (MRI), it seems to be associated with a clinical complete brachial plexus block
    

Intervention name(s): Active Comparator: Arm 1: catheter injection; Active Comparator: Arm 2: transarterial injection; Active Comparator: Arm 3: catheter and transarterial injection
Intervention type(s): Procedure; Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Peripheral Nerves; Axillary Block; MRI
Addition of Phytosterols to a Low Phytosterol Diet
Condition: Hypercholesterolemia; Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Hypercholesterolemia
Study type: Interventional

Summary: 
      Studies have shown that phytosterols will lower LDL cholesterol. Typical diets can contain
      between 250 to 500 mg of naturally-occurring phytosterols. Long-term studies with
      phytosterol-containing products(such as margarines) have not taken into account the amounts
      of naturally occurring phytosterols in the diet. This means that the effects of small amounts
      of natural dietary phytosterols on LDL cholesterol are not known. In this study, we will
      examine the effects of phytosterols across a range of levels. The information will likely be
      used to further support and possibly extend the current dietary recommendations for
      phytosterol use.
    


Intervention name(s): Different amount of phytosterols are added into diets
Intervention type(s): Dietary Supplement
Intervention description(s): Diets with 59, 400, or 2000 mg of phytosterols daily for 4 weeks were given to each subject, in random order.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: phytosterols; cholesterol excretion; cholesterol absorption; diet; mass spectrometry; deuterium
Physical Performance and Analgesic Effects of tDCS in Primary Dysmenorrhea
Condition: Transcranial Direct Current Stimulation; Dysmenorrhea Primary; Pain; Mental Disorders; Physical Fitness
MeSH terms: Dysmenorrhea; Mental Disorders
Study type: Interventional

Summary: 
      Technological advances and non-invasive techniques to modulate brain function have been
      developed, including transcranial Direct Current Stimulation (tDCS). Basically, electrodes
      are placed on the brain regions to stimulate or inhibit it. Subsequently, a continuous
      electrical current (0.4-2 mA) is imposed, for a period of 3-20 minutes, to modify cortical
      excitability. Few are the research groups that work on the topic of primary dysmenorrhea and
      the use of tDCS as the focus of study. Preliminary studies associated the use of tDCS with
      pain reduction, but the outcomes of physical and behavioral function needs further
      investigation.
    


Intervention name(s): Active Transcranial Direct Current Stimulation; Sham Transcranial Direct Current Stimulation
Intervention type(s): Device; Device
Intervention description(s): For electrode placement, the criteria used by the 10/20 electroencephalography system will be obeyed and the electrodes will be positioned over Primary motor cortex, C3 area for the anode and Fp2 (contralateral supraorbital area) for the cathode electrode. A constant current of 2mA will be applied for 20 minutes.; For electrode placement, the criteria used by the 10/20 electroencephalography system will be obeyed and the electrodes will be positioned over primary motor cortex, C3 area for the anode and Fp2 (contralateral supraorbital area) for the cathode electrode, but the stimulator will be turned off after 30 seconds of stimulation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Shotblocker, Finger Puppet And Balloon Method During Intramuscular Injection
Condition: Children
Study type: Interventional

Summary: 
      The aim of the randomized controlled study is to examine the effects of ShotBlocker, finger
      puppet and balloon inflation methods applied during intramuscular injection procedure on
      children's pain and fear level.
    

Detailed description: 
      The aim of the randomized controlled study is to examine the effects of ShotBlocker, finger
      puppet and balloon inflation methods applied during intramuscular injection procedure on 7-12
      age group children on pain and fear level.

      The purpose of the research and all the working processes were explained to the children and
      parents by the researcher.

      Children who met all eligibility criteria were invited to participate in the study with their
      parents.

      The children and their parents were informed about the study, they were included in the study
      by announcing that they would be in one of the four groups, and this group was randomly
      determined.

      Before starting the application, verbal and written consent was obtained from the parents of
      the children by reading/reading the Informed Voluntary Consent Form.

      The child and parent were informed by the researcher about the pain and fear level assessment
      tools and application before and after the procedure.
    

Intervention name(s): ShotBlocker; Finger Puppet group; Balloon group
Intervention type(s): Device; Other; Other
Intervention description(s): Before the procedure, the protruding surface of the vehicle was placed on the injection site in contact with the skin and used by holding it during injection. The level of pain and fear experienced by the child during and 5 minutes after the injection was evaluated with the "Facial Expressions Pain Scale" and "Visual Comparison Scale", and the level of fear was evaluated with the "Child Fear Scale" by the child, the parent accompanying the child, and the observer.; During the interaction between the finger puppet and the child, an intramuscular injection was made. The level of pain experienced by the child during the injection and 5 minutes after the injection was evaluated by the child, the parent and the observer through the "Facial Expressions Pain Scale" and the "Visual Comparison Scale", and the fear level by the "Child Fear Scale".; An intramuscular injection was given when the child began to inflate the balloon. The level of pain experienced by the child during the injection and 5 minutes after the injection was evaluated by the child, the parent and the observer through the "Facial Expressions Pain Scale" and the "Visual Comparison Scale", and the fear level by the "Child Fear Scale".
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Karydakis Procedure Versus Excision With Healing by Secondary Intention (EHSI) in Sacrococcygeal Pilonidal Sinus
Condition: Pilonidal Sinus; Pilonidal Cyst
MeSH terms: Pilonidal Sinus
Study type: Interventional
Phase: Phase 4

Summary: 
      Recurrence, Complications, Work-off date, Healing time and Patients Willingness in Karydakis
      Technique for Treatment of Sacrococcygeal Pilonidal Sinus versus Healing by Secondary
      Intention (EHSI) Technique in Imam Khomeini Hospital from 2008 to 2011
    


Intervention name(s): karydakis flap; laying open
Intervention type(s): Procedure; Procedure
Intervention description(s): Karydakis flap is a type of primary repair of the wound, after complete excision of sacral pilonidal cyst with 2 characteristics 1)lateralization of final scar 2)flattening of natal cleft; laying open the site of excision of sinus or cyst without any flap
Other intervention name(s): lateralization; primary repair
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pilonidal sinus; karydakis; laying open