bioihbjkbjnl/mcl2 huggingface dataset:
Gemcitabine in Treating Patients With Advanced Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of gemcitabine in treating patients who
      have advanced colorectal cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the response rate in patients with advanced colorectal cancer treated with
           gemcitabine.

        -  Determine the toxic effects of this drug in these patients.

        -  Determine the progression-free survival of patients treated with this drug.

      OUTLINE: This is a multicenter study.

      Patients receive gemcitabine IV continuously over 24 hours on days 1, 8, and 15. Treatment
      repeats every 28 days for a total of 6 courses in the absence of disease progression or
      unacceptable toxicity.

      Patients are followed every 6 months.

      PROJECTED ACCRUAL: A total of 12-41 patients will be accrued for this study within 2 years.
    

Intervention name(s): gemcitabine hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Gemcitabine
Primary purpose: Treatment
Keywords: stage III colon cancer; stage IV colon cancer; stage III rectal cancer; stage IV rectal cancer; recurrent colon cancer; recurrent rectal cancer
GLS4/RTV and TAF Drug-drug Interaction
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis B; Hepatitis B, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the drug-drug-interaction (DDI), pharmacokinetics
      (PK) and tolerability of GLS4/RTV combined with TAF in healthy subjects.
    

Detailed description: 
      This is a 2-part study with each part is an open-label study in healthy adult subjects.

      Total 28 subjects will be enrolled into the study and divided into 2 part (Part A and Part
      B), 14 subjects in each part. With each part, the subject will be receive study drug per the
      defined treatment periods.
    

Intervention name(s): GLS4; RTV; TAF
Intervention type(s): Drug; Drug; Drug
Intervention description(s): It is a new dihydropyrimidine antiviral drug that interferes the assembly of HBV core granule.; It is HIV protease inhibitors indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection;
It is a CYP3A inhibitor combined with other drug to increase the exposure in human.; It is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor and is indicated for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease.
Other intervention name(s): ritonavir; tenofovir alafenamide
Intervention MeSH terms: Ritonavir; Tenofovir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Paclitaxel Coated Balloon Catheter for Prevention of Restenosis in Femoropopliteal Arteries
Condition: Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The PACCOCATH FEM study is a randomized, double-blinded German multicenter trial on the
      efficacy and tolerance of a paclitaxel coated balloon catheter in prevention of restenosis
      after femoropopliteal angioplasty.
    

Detailed description: 
      Background: Treatment of patients with peripheral arterial disease (PAD) in the
      femoropopliteal arteries by percutaneous intervention is still limited by high rates of
      restenosis. The aim of the present study is to evaluate the efficacy and safety of a novel
      method of short time local drug delivery based on a paclitaxel-coated balloon in
      femoropopliteal arteries.

      Methods and results: The double-blind and randomized study enrolled n=79 patients with
      occlusion or stenosis of femoropopliteal arteries. Inclusion criteria were clinical
      Rutherford stage 1-5, occlusion or hemodynamic relevant stenosis (≥ 70 % diameter) of
      femoropopliteal arteries and successful guiding wire recanalization. The primary endpoint was
      the late lumen loss after 6 months follow-up as seen in angiography. Secondary endpoints
      included the rate of restenosis (a binary variable), change of ankle brachial index (ABI),
      rutherford class and major adverse events.
    

Intervention name(s): paclitaxel coated balloon catheter (device with drug)
Intervention type(s): Device
Intervention description(s): PTA vs Paccocath
Intervention MeSH terms: Paclitaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: restenosis; peripheral arterial disease; paccocath; drug-coated balloon
The EarLens System Long Term Safety and Efficacy Definitive Multi-Center Study
Condition: Hearing Impairment
MeSH terms: Hearing Loss; Deafness
Study type: Interventional

Summary: 
      The EarLens System is an assistive hearing device that is intended to provide amplification
      for the treatment of patients with sensorineural hearing impairment. The purpose of this
      multi-center definitive study is to assess the safety and efficacy of the EarLens System for
      subjects with bilateral mild to severe sensorineural hearing impairments wearing the fully
      activated system in their daily lives for a 4 month period of time. This study is designed to
      support US and International marketing applications to commercialize the EarLens System. The
      main efficacy hypothesis is that the EarLens System will be shown to improve speech
      understanding in quiet.
    


Intervention name(s): Sound amplification provided via EarLens System.
Intervention type(s): Device
Intervention description(s): The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hearing impairment; Hearing loss
A Brief Alcohol Intervention for Incarcerated Women
Condition: Alcohol Use; Incarceration
MeSH terms: Alcohol Drinking
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine the efficacy of a brief motivational intervention for
      alcohol use in incarcerated women.
    

Detailed description: 
      Hazardous alcohol use continues to be a problem of major significance throughout the United
      States. Alcohol use is a prevalent condition that independently acts as an important
      behavioral cofactor for HIV infection in women, contributing to both sexual and drug risk.
      The rationale for a brief intervention with incarcerated women who hazardously use alcohol
      and have HIV risk behaviors is compelling. For such women, we believe that the negative
      effects of drinking may be increased. An intervention that successfully connects alcohol use
      with HIV risk behaviors may be sufficient to tip the decisional balance in favor of reducing
      risk-prone alcohol consumption. If alcohol consumption is reduced more generally in a
      person's life, this may improve judgment in pursuing behaviors which risk other negative
      consequences. Hazardous alcohol, and high-risk drug and sexual activities may be
      manifestations of a general behavior pattern among incarcerated women, and strategies that
      engage such individuals are needed. Given the strong association between hazardous alcohol
      use and high HIV risk sexual and drug activities, interventions that attempt to lower the
      prevalence of HIV drug and sexual risk activities by lowering alcohol consumption are well
      justified. Brief alcohol interventions have been efficacious in reducing alcohol use across
      many populations over the past decade.

      Comparison(s): Participants are assigned, in this 6 month study, to an assessment-only
      condition or an assessment plus motivational interview condition. Two motivational interview
      sessions are conducted during the first month of study participation.
    

Intervention name(s): motivational interviewing
Intervention type(s): Behavioral
Intervention description(s): Assessment plus motivational interview condition -- two motivational interview sessions are conducted during the first month of this six month study participation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: women; incarceration; alcohol use; motivational interviewing
Tailored Communication to Reduce Cardiovascular Risk
Condition: Hypercholesterolemia; Coronary Artery Disease; Dyslipidemia; Hypertension
MeSH terms: Coronary Artery Disease; Hypercholesterolemia; Dyslipidemias
Study type: Interventional

Summary: 
      The primary goal of the trial is to test the feasibility and efficacy of a cardiovascular
      disease quality improvement system that couples EMR-based patient identification with
      individually tailored patient messages. The study will test the hypothesis that that a
      tailored patient-directed approach to cardiovascular risk reduction integrated into patients'
      primary care delivery site will improve control of elevated low-density lipoprotein
      cholesterol and other card iac risk factors more than routine care alone for patients at
      intermediate or high risk for cardiovascular disease.
    


Intervention name(s): Direct-to-patient tailored cardiovascular risk message system
Intervention type(s): Behavioral
Intervention description(s): Patient informational mailings
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Health Education; Health Knowledge, Attitudes, Practice; Hypolipidemic Agents/therapeutic use; Patient Education as Topic
A Pharmacokinetic Interaction Study Between Apatinib Mesylate and Transporter Pgp Substrate Digoxin in Advanced Solid Tumor Subjects
Condition: Advanced Solid Tumor
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Apatinib, an oral inhibitor of vascular endothelial growth factor receptor 2#VEGFR-2#,
      Induces Transporter Pgp function in vitro. This study in patients with advanced cancer
      evaluated the effect of Apatinib on Transporter Pgp function by comparing the
      pharmacokinetics of Transporter Pgp-specific probe drugs in the presence and absence of
      Apatinib. The probes used Substrate Digoxin.
    


Intervention name(s): Apatinib Mesylate; Digoxin tablet
Intervention type(s): Drug; Drug
Intervention description(s): Apatinib at a dosage of will be administered daily from on D5 through D16; Digoxin at a dosage of 0.25mg will be administered at day 1 and day 12
Intervention MeSH terms: Apatinib; Digoxin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial Seizures
Condition: Epilepsy; Partial Seizures
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      Objective of the First Period: To evaluate the efficacy of Levetiracetam dry syrup at doses
      up to a maximum of 60 mg/kg/day or 3000 mg/day used as an adjunctive therapy in Japanese
      pediatric patients (4 to 16 years) with uncontrolled partial seizures despite treatment with
      1 or 2 anti-epileptic drug(s).
    

Detailed description: 
      Objectives of the Second Period: To provide the Levetiracetam treatment to subjects who are
      judged by the investigators to benefit from the long-term treatment and who are willing to
      continuously receive this drug. To continuously evaluate the safety of the Levetiracetam
      long-term administration at doses ranging from 20 mg/kg/day or 1000 mg/day to 60 mg/kg/day or
      3000 mg/day in subjects who completed the First Period of this study.
    

Intervention name(s): Levetiracetam
Intervention type(s): Drug
Intervention description(s): First Period: Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.
Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.
Other intervention name(s): Keppra
Intervention MeSH terms: Levetiracetam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Keppra; Levetiracetam; Children; Epilepsy; Partial Seizures
Mirror Therapy Versus CIMT on Hand Function in Cerebral Palsy
Condition: Hemiplegic Cerebral Palsy; Mirror Hands
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The aim is to investigate the effect of mirror therapy on hand functions in children with
      hemiplegic cerebral palsy.
    

Detailed description: 
      Hemiplegic cerebral palsy (HCP) is a form of paralysis that affects motor performance and
      muscle tone on one side of the body. Spastic hemiplegia CP is the second form of cerebral
      palsy in premature infants, affecting one side of the body's limbs. Hand and upper limb
      dysfunction cause problems in half of the children with cerebral palsy. Mirror therapy is a
      growingly recognized new treatment option for hemiplegic cerebral palsy. While upper
      extremity involvement in hemiplegic CP and the residual effects are more severe, there is
      limited evidence of the efficacy of mirror treatment in children with hemiplegic CP
    

Intervention name(s): Physical therapy exercises; Mirror therapy; Constraint Induced Movement Therapy
Intervention type(s): Other; Other; Other
Intervention description(s): Three times a week for 12 weeks.; Three times a week for 12 weeks.; Three times a week for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Study (2 groups) and control
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mirror therapy; Hand function; Grip strength
Radiographic Evaluation of The Labial Bone Dimensional Changes After Immediate Implant
Condition: Immediate Implants; Esthetic Zone; Labial Bone Dimensional Changes; Without Labial Bone Grafting; With Labial Grafting; Thin Labial Plate of Bone Pre-extraction
Study type: Interventional

Summary: 
      For the dimension of the peri-implant buccal gap, a controversy is present whether complete
      bone formation labial to the implant. Therefore, leaving the blood clot in the large socket
      around implants without augmentation is questionable to result in complete bone fill and
      would not affect the buccal contour collapse. The aim of this clinical trial was to evaluate
      the labial bone dimensional changes after immediate implant placement in the esthetic zone
      with & without bone grafting inside the socket by using CBCT superimposition (Fusion) scans.
    


Intervention name(s): immediate implant placement without bone grafting; immediate implant placement with socket bone grafting
Intervention type(s): Procedure; Procedure
Intervention description(s): After atraumatic extraction of the non-restorable tooth using periotome and luxators, osteotomy site preparation will be done & patients will receive an immediate post-extraction implant without any grafting material in the socket between the residual labial bone and implant surface. After implant insertion, the labial bone dimensions of the buccal peri-implant defect will be measured using Automated Voxel Superimposition Method of CBCT scans. All the patients in this study had two scans; primary (preoperative) scan and secondary (Postoperative) scan, with standardization of the exposure parameters. All datafrom CBCT examinations were acquired in a DICOM format which were imported to OnDemand3D ®App software (Cybermed, Seoul, Korea). superimposition of DICOM sets of each patient using Fusion module of Ondemand 3D App software was done.; After atraumatic extraction of the non-restorable tooth using periotome and luxators, osteotomy site preparation will be done and patients will receive an immediate post-extraction implant with placing bovine bone graft (Bio-oss) in the socket between the residual labial bone and implant surface. After implant insertion, the labial bone dimensions of the buccal peri-implant defect will be measured using Automated Voxel Superimposition Method of CBCT scans. All the patients in this study had two scans; primary (preoperative) scan and secondary (Postoperative) scan, with standardization of the exposure parameters. All datafrom CBCT examinations were acquired in a DICOM format which were imported to OnDemand3D ®App software (Cybermed, Seoul, Korea). In order to ensure standardization and reproducibility of the CBCT cross sectional images used in this study, superimposition of DICOM sets of each patient using Fusion module of Ondemand 3D App software was done.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Phase III Study Comparing Zegerid® With Losec® for the Relief of Heartburn Associated With Gastroesophageal Reflux Disease
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Heartburn
Study type: Interventional
Phase: Phase 3

Summary: 
      Heartburn is the main symptom of Gastroesophageal Reflux Disease (GERD), which, accompanied
      by acid regurgitation and other symptoms, has a substantial negative impact on a patients'
      quality of life. Although a number of treatment options are available, a more effective
      therapy is still required. The failure of proton pump inhibitors (PPIs) to completely resolve
      symptoms is an accepted problem, with approximately 25% of patients with GERD continuing to
      experience the symptoms of heartburn in spite of treatment. This study aims to demonstrate an
      earlier onset to relief of symptoms in patients suffering from heartburn associated with GERD
      using an immediate-release omeprazole/sodium bicarbonate formulation when compared with
      delayed-release omeprazole (Losec®).
    


Intervention name(s): Zegerid; Losec
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg Zegerid suspension to be taken when heartburn occurs. Maximum one dose per day on 3 out of 14 days.; 20 mg Losec capsule to be taken when heartburn occurs. Maximum one dose per day on 3 out of 14 days.
Intervention MeSH terms: Omeprazole, sodium bicarbonate drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Subjects With T1DM
Condition: Hypoglycemia; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Hypoglycemia; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      A randomized, double-blind, parallel-group trial to confirm the clinical efficacy and safety
      of dasiglucagon in the rescue treatment of hypoglycemia in subjects with type 1 diabetes
      mellitus (T1DM) compared to placebo
    

Detailed description: 
      Subjects were randomized in a ratio of 3:1 to receive a single subcutaneous dose of
      dasiglucagon (0.6 mg) or matching placebo. Randomization also determined whether the subject
      was to be injected in the buttock or deltoid. During the dosing visit (Visit 2), hypoglycemia
      was induced by a fast-acting insulin glulisine (Apidra®) infusion, and trial drug was
      administered when the subject's plasma glucose level was 45-60 mg/dL (2.5-3.3 mmol/L). During
      the insulin-induced hypoglycemia, pharmacokinetic and pharmacodynamic samples were drawn, and
      plasma glucose levels were monitored closely at site for safety reasons. A rescue glucose
      infusion could be administered to ameliorate persistent hypoglycemia. Subjects were followed
      for at least 28 days after dosing to perform an adequate immunogenicity evaluation of
      treatment.
    

Intervention name(s): Dasiglucagon; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Glucagon analogue; Placebo for dasiglucagon
Other intervention name(s): ZP4207; Placebo for dasiglucagon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: glucagon
Effect of iNO on Invasively Derived Pulmonary Pressures in Patients With PAH
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      Pulmonary hypertension is characterized by an increase in the pressures in the blood supply
      to the lungs greater than a mean pressure of 25mmHg and a concomitant increase in overall
      pulmonary vascular resistance (PVR). In patients who have remodeling of their pulmonary
      vasculature, PVR will increase with exercise instead of decreasing as it would in normal
      patients. Based on published evidence, the investigators intend to investigate the effects of
      inhaled nitric oxide (iNO) on patients undergoing standard exercise techniques who have
      separately and previously had an implanted pulmonary artery monitoring device (CardioMems by
      St Jude Medical, Inc.) placed.
    


Intervention name(s): Nitric Oxide
Intervention type(s): Drug
Intervention description(s): Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test
Other intervention name(s): iNOPulse DS
Intervention MeSH terms: Nitric Oxide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Inhaled nitric oxide; Exercise; 6 minute walk test; CardioMems