bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Minimal Invasive Thyroidectomy
Condition: Thyroid; Goiter
MeSH terms: Goiter
Study type: Interventional

Summary: 
      The goals of minimally invasive approaches are better cosmetic results with small neck scar,
      decreasing postoperative pain, and shortening of hospital stay periods without postoperative
      complications.

      The concept of surgical invasiveness cannot be limited to the length and site of the skin
      incision; it must be extended to all structures dissected during the procedure. Conventional
      thyroidectomy without raising subplatysmal flaps has proven to be effective in reducing
      postoperative pain and seroma
    

Detailed description: 
      Minimal invasive flapless thyroidectomy (MIFT) is a new technique that can be used in
      replacement of the conventional method of thyroidectomy for the management of selected cases
      of benign thyroid disorders.

      This work aims to evaluate the feasibility, safety, and efficacy of Minimal Invasive Flapless
      Thyroidectomy (MIFT) in the management of thyroid disease as regards postoperative pain,
      cosmesis, operative time, and other postoperative complications in comparison to Conventional
      thyroidectomy technique.
    

Intervention name(s): Thyroidectomy
Intervention type(s): Procedure
Intervention description(s): removal of the thyroid gland
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Exploratory Study to Explore the Safety and Efficacy of the HDx Therapy Using Theranova 500 Dialyzer in Comparison to Hemodiafiltration
Condition: End Stage Renal Disease
MeSH terms: Kidney Failure, Chronic
Study type: Interventional

Summary: 
      Today it is well established that middle molecules comprise several compounds that are not
      effectively removed by high-flux dialyzers, and effective clearance of large middle molecules
      in the process of dialysis depends on the dialyzer membrane having large enough pore sizes,
      larger than the conventional high-flux dialyzers. Studies have found associations between
      levels of large middle molecule uremic toxins and immune dysfunction and inflammation, as
      well as adverse outcomes. This indicates that dialysis membranes having larger pores,
      enabling an expanded HD (HDx) with more effective removal of large middle molecules, can have
      a positive impact on the inflammatory state. While data is starting to appear on the
      long-term use of the HDx therapy, little is still known on how large middle molecules and
      inflammation markers are affected over time.
    


Intervention name(s): Theranova 500 medium cut-off dialyzer; Hemodiafiltration
Intervention type(s): Device; Device
Intervention description(s): The patients randomized in this group using the Theranova 500 medium cut-off dialyzer, and blood flow rate and treatment duration will be maintained stable during the observation period. However, other prescriptions will vary based on the Principal Investigator's (PI's) judgment. If other dialyzers need to be temporarily used during the study period it shall be recorded which alternative dialyzers are used and for how long the study patient is on a different dialyzer. However, prior to Week 12 laboratory assessment it is recommended that the patient undergoes three dialysis sessions on the designated treatment mode.; The patients randomized in this group using the on-line high-flux HDF dialyzer, in post dilution mode, will continue to receive treatments according to their current treatment prescriptions for the duration of the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Standard (180mg) Versus Double (360mg) Loading Dose of Ticagrelor in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)
Condition: ST-elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multi-center, prospective, randomized, single-blind, investigator initiated,
      pharmacodynamic study of parallel design, performed at 3 institutions (Patras University
      Hospital; Evangelismos Athens General Hospital; Gennimatas Athens General Hospital).

      Patients with ST elevation myocardial infarction (symptom onset < 12 hours), undergoing
      primary percutaneous coronary intervention, who are antiplatelet naïve (Group A) or present
      high residual PR (defined as PRU ≥ 208) immediately before primary percutaneous coronary
      intervention, will be randomized after informed consent, in a 1:1 ratio to either:

      Ticagrelor 180mg loading dose (LD), followed by a 90mg x2 maintenance dose (MD )starting 12±6
      hours post LD Or Ticagrelor 360mg loading dose (LD), followed by a 90mg x2 maintenance dose
      (MD) starting 12±6 hours post LD Platelet reactivity assessment will be performed at
      randomization (Hour 0) and at 0.5, 1, 2, 4 hours after randomization, using the VerifyNow
      assay, in platelet reactivity units (PRU).

      Documentation of major adverse cardiac events (death, myocardial infarction, stroke, urgent
      revascularization procedure with PCI or CABG) and bleeding (according to Bleeding Academic
      Research Consortium criteria) will be performed until patient's discharge.
    


Intervention name(s): Ticagrelor; Ticagrelor
Intervention type(s): Drug; Drug
Intervention description(s): Ticagrelor 360mg loading dose immediately pre prior percutaneous coronary intervention 360mg loading dose; Ticagrelor 180mg loading dose 180mg loading dose
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ticagrelor; ST elevation acute myocardial infarction; Platelet reactivity
Employment-Based Depot Naltrexone Clinical Trial II
Condition: Opiate Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether employment-based naltrexone treatment
      proves effective in promoting depot naltrexone adherence and drug abstinence.
    

Detailed description: 
      A randomized study is planned to evaluate the effectiveness of employment-based reinforcement
      in promoting depot naltrexone adherence in opiate-dependent adults. Vivitrol, an
      extended-release depot formulation of naltrexone approved by the FDA for the treatment of
      alcohol dependence, will be used. Participants will be offered an inpatient opioid
      detoxification and oral naltrexone induction. Participants who complete the oral naltrexone
      induction (N=40) will be randomly assigned to one of two groups. Both groups will be invited
      to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months.
      Participants in the "Work Plus Naltrexone Contingency" condition will earn access to working
      and earning salary by taking depot naltrexone injections once per month. "Work Plus
      Naltrexone Prescription" participants will be encouraged to take depot naltrexone monthly,
      but access to working and earning salary will not be contingent on doing so.
    

Intervention name(s): Work Plus Naltrexone Contingency
Intervention type(s): Combination Product
Intervention description(s): Vivitrol, an extended-release depot formulation of naltrexone, was used. Participants were offered an inpatient opioid detoxification and oral naltrexone induction. Participants who complete the oral naltrexone induction (N=40) were randomly assigned to one of two groups. Both groups will be invited to work in the Therapeutic Workplace and will be prescribed depot naltrexone for 6 months. Participants in the "Work Plus Naltrexone Contingency" condition earned access to working and earning salary by taking depot naltrexone injections once per month.
Other intervention name(s): contingency management
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of THN102 in Patients With Parkinson's Disease and Excessive Daytime Sleepiness
Condition: Parkinson Disease
MeSH terms: Parkinson Disease; Disorders of Excessive Somnolence; Sleepiness
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, placebo-controlled, 3-way cross-over phase IIa trial comparing two dose
      levels of THN102 to placebo in patients suffering from Parkinson's disease associated with
      excessive daytime sleepiness.
    

Detailed description: 
      The treatment duration is 2 weeks per period. Each treatment period is followed by a one-week
      washout period.
    

Intervention name(s): THN102 Dosage A; THN102 Dosage B; THN102 Dosage C
Intervention type(s): Drug; Drug; Drug
Intervention description(s): THN102 Dosages A: placebo; THN102 Dosage B : 200mg/2mg; THN102 Dosage C: 200mg/18mg
Other intervention name(s): Placebo; Dosage B; Dosage C
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Complete 3 way-Crossover
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Prognostic Relevance of High-sensitivity Troponin in Patients With Acute Decompensated Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      The purpose of this study is to investigate the prognostic value of admission
      high-sensitivity troponin in patients with acute decompensated heart failure.
    

Detailed description: 
      Patients admitted for acute decompensated heart failure are included in the study. After
      gaining informed consent, concentrations of high-sensitivity troponin on admission and on
      discharge are assessed. 6 months after discharged, the incidence of clinical endpoint
      (mortality of all cause and of cardiovascular cause, hospitalization) is assessed by
      telephone contact to the patient and/or the physician. The aim of the study is to investigate
      the prognostic value of high-sensitivity troponin concentration for predicting death and
      re-hospitalization.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Primary care clinic
      
Keywords: Troponin concentration in heart failure
The Removing Port of the Laparoscopic Cholecystectomy Material
Condition: Wound Infection
MeSH terms: Infections; Wound Infection
Study type: Interventional

Summary: 
      Laparoscopic cholecystectomy is gold standard for gallstones. In this study the investigators
      are investigating the effect of the removing of cholecystectomy material from different
      ports, to the port site infections.
    

Detailed description: 
      Laparoscopic cholecystectomy is gold standard for gallstones. But there is no consensus about
      which port place is optimal for the removing of the cholecystectomy material from the
      abdomen. There are different port site infections rates in the literature. The minimal tissue
      damage of laparoscopic cholecystectomy suggests a lower risk of wound infection, but there
      are series with an infection range of 8 %. The investigators are investigating is there any
      difference at the port site infection rates when the cholecystectomy material removed from
      different ports from the abdomen at the laparoscopic cholecystectomy.
    

Intervention name(s): Removing from Epigastric port
Intervention type(s): Procedure
Intervention description(s): The cholecystectomy material will be removed from epigastric port. This will be experimental group. Port site infection rates will be measured
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Port; Infection; cholecystectomy
HYDEAL-D® Application for Promoting the Restoration of Sexual Function in the Postpartum Period
Condition: Vagina; Anomaly; Puerperium; Disease; Sexual Dysfunction
MeSH terms: Puerperal Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      During postpartum and lactation, vaginal epithelium tends to have an impaired degree of
      hydration and lubrication. This may lead to vaginal dryness, burning sensation dyspareunia or
      itching, which negatively affect the sexual function of puerperal women.

      This study aimed to evaluate the efficacy of HYDEAL-D® vaginal gel (HYALOGYN®, Fidia
      Farmaceutici, Abano Terme, Italy) application on promoting the restoration of sexual function
      in the postpartum period.
    


Intervention name(s): Vaginal gel HYALOGYN®; Expectant management
Intervention type(s): Drug; Behavioral
Intervention description(s): Vaginal gel HYALOGYN® (HYDEAL-D® 2%; Fidia Farmaceutici, Abano Terme, Italy) every 3 days up for 12 consecutive weeks; Expectant management for 12 consecutive weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Puerperium
Study to Characterize the Pharmacokinetics of Raltegravir in the Gastrointestinal (GI) Tract of Healthy Male Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the way the first commercially available
      integrase inhibitor, raltegravir, a new class of antiretrovirals that is used to treat HIV,
      is distributed into the rectal mucosal tissue. This information will generate important
      information regarding the drug's penetration into lymphoid tissues that are rapidly depleted
      in HIV infection. Subsequently strategies to prevent the sexual transmission of HIV and for
      treating HIV-infected individuals will be designed.
    

Detailed description: 
      Participants: 14 HIV-uninfected, healthy, male volunteers, ≥18 and ≤49 years of age, will be
      recruited and enrolled. Healthy is defined as no clinically relevant abnormalities identified
      by a detailed medical history, full physical examination, including blood pressure and pulse
      rate measurement, 12-lead ECG, and clinical laboratory tests. Participants of all races and
      ethnicities will be considered for enrollment. This study will be conducted at a single site
      in the United States: the University of North Carolina at Chapel Hill.

      Procedures (methods): An outpatient screening visit will be conducted on all potential
      participants to obtain informed consent and evaluate for eligibility. Once enrolled, all
      subjects will take 400 mg oral dose of raltegravir twice daily from Day 1 to Day 7. The
      healthy men enrolled in this study will undergo single-dose and multiple-dose pharmacokinetic
      sampling. Blood will be collected via peripheral IV at pre-dose, and at 1, 2, 3, 4, 6, 8 and
      12 hours post-dose. Subjects will undergo two colonoscopies during sampling visits (Day 1 and
      Day 7) for the purpose of obtaining gastrointestinal-associated lymphoid tissue (GALT). Each
      subject will have his biopsy obtained at one of the following time points post-dose: 1, 2, 3,
      4, 6, 8, and 12 hours. Seven to ten days after their last inpatient sampling visit, all
      subjects will complete a follow-up visit.
    

Intervention name(s): Raltegravir
Intervention type(s): Drug
Intervention description(s): 400 mg tablets by mouth BID from Day 1 - Day 7 after enrollment visit
Other intervention name(s): MK-0518; ISENTRESS
Intervention MeSH terms: Raltegravir Potassium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: raltegravir; pharmacokinetics; healthy; male; volunteers; gastrointestinal; tract
An Efficacy and Safety Study for JNS001 in Adults With Attention-Deficit Hyperactivity Disorder
Condition: Attention-Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The main purpose of this study is to evaluate the efficacy of JNS001 titrated to daily doses
      of 18 to 72 mg in adults with attention-deficit hyperactivity disorder (ADHD) relative to
      placebo.
    

Detailed description: 
      This is a randomized (the study drug is assigned by chance), double-blind (DB, neither
      physician nor patient knows the name of the assigned drug), multicenter, placebo-controlled,
      parallel group (each group of patients will be treated at the same time), dose-titration
      study. This study consists of a screening period, a DB phase (titration period and efficacy
      assessment period), and post-study phase. The study includes a 1 to 2-week screening period
      for wash-out of prohibited drugs, and screening for eligibility. Eligible patients will be
      randomly assigned to receive JNS001 or placebo in a ratio of 1:1. The study also includes a
      4-week titration period. Patients will be titrated from a starting dose of 18 mg/day or
      matching placebo for 7 days (+/- 2 days), and continue with a weekly (+/- 2 days) increment
      of 18 mg until an individualized dose is achieved. Once an individualized dose is achieved,
      patients will remain on that dose for the rest of the titration period as far as tolerable.
      Doses can be tapered down only once during the titration period in the study, and their dose
      cannot be up-titrated again for the rest of the period. The 4-week titration period will be
      followed by the 4-week efficacy assessment period. The post-study phase for collection of
      additional safety data will be scheduled for 1 week after a patient's final study treatment.
      The study drug will be administered with water once daily in the morning at doses of 18 mg,
      36 mg, 54 mg, 72 mg per day or the matching placebo. The study treatment period is 8 weeks
      (titration period of 4 weeks and efficacy assessment period of 4 weeks).
    

Intervention name(s): JNS001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.; Participants will receive matching placebo orally once daily for 8 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Concerta; Adults; Attention-Deficit/Hyperactivity Disorder; ADHD; Methylphenidate hydrochloride
Induction FOLFOX With or Without Aflibercept Followed by Chemoradiation in High Risk Locally Advanced Rectal Cancer
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial compares induction treatment with FOLFOX with or without aflibercept in a high
      risk population selected by MRI, prior to receiving standard chemoradiation (capecitabine
      combined with 50.4 Gy in 28 days) and surgery, in order to evaluate the efficacy in terms of
      pathologic complete response (pCR).
    

Detailed description: 
      This is a randomized trial comparing induction treatment with FOLFOX with or without
      aflibercept in a high risk population selected by MRI, prior to receiving standard
      chemoradiation (capecitabine combined with 50.4 Gy in 28 days) and surgery. Once it is
      confirmed that the subjects fulfill the eligibility criteria (MRI-defined high risk RC), and
      have signed the informed consent, a central review will be requested to confirm clinical
      stage, and then they will be randomized to receive mFOLFOX6 + Aflibercept or mFOLFOX6
      (without Aflibercept).

      Random assignment of treatment will be stratified by T3 versus T4 stage. All the patients
      enrolled in the study will receive one cycle of study medication (mFOLFOX6 with or without
      aflibercept) every 14 days for six cycles, unless unacceptable toxicity or progression is
      detected. After this treatment, patients will receive standard chemo-radiotherapy (CT/RT)
      (capecitabine 825 mg/m2 twice daily combined with a total dose of 50.4 Gy in 28 days)
      followed by surgery, provided they have not progressed.

      Patients with progression disease during the treatment phase will be withdrawn from the study
      and will receive their treatment according to the investigator's judgment. If a patient
      withdraws consent and refuses to receive further treatment, the patient must be followed up
      for 3 years from randomization or until progression, to evaluate disease-free survival. If a
      patient withdraws consent and refuses to continue in the study, the follow-up evaluations
      must be discontinued.
    

Intervention name(s): Aflibercept; 5-Fluoruracil; Oxaliplatin; Leucovorin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered I.V. at doses of 4 mg/Kg on Day 1 every 14 days. It will be supplied to sites by Sponsor as 4 ml vials at a concentration of 25 mg/ml; Once every 14 days. Day 1: 400 mg/m2 I.V. bolus and a 46 h infusion of 5-FU 2400 mg/m2; Once every 14 days. Day 1: 85 mg/m2 I.V. infusion in 250-500 mL, over two hours, followed by 5-FU; Once every 14 days. Day 1: 200 mg/m2 I.V., over two hours, followed by 5-FU
Other intervention name(s): ZALTRAP; 5-FU; Any marketed; Any marketed
Intervention MeSH terms: Leucovorin; Oxaliplatin; Aflibercept; Fluorouracil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pooled Analysis FP_SX_250_50
Condition: Asthma
Study type: Observational

Summary: 
      A pooled analysis of three bioequivalence studies conducted for Fluticasone propionate 250
      mcg and salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals (Test, T) vs
      ADVAIR DISKUS® 250/50 mcg inhalation powder/GSK (Reference, R) were conduted.
    

Detailed description: 
      Data from three Bioequivalence studies with study codes: BECRO/RESP/BREATH-BE250-PIVOTAL
      (BE250-PIVOTAL), BECRO/RESP/BREATH-BE250-PILOT (BE250-PILOT) and BECRO/RESP/BREATH-PK250
      (PK250) were included.

      A pooled analysis of all three studies was conducted, including all eighty-two (82) subjects
      of the three studies. Then, a pooled analysis of the BE250-PIVOTAL and the respective Pilot
      study (BE250-PILOT) was also conducted since these two studies used products of the same
      batch, including forty-eight (48) subjects.
    

Intervention name(s): Test; Reference
Intervention type(s): Drug; Drug
Intervention description(s): 2 inhalations of Test and Reference product in each study period; 2 inhalations of Test and Reference product in each study period
Other intervention name(s): Fluticasone propionate 250 mcg and salmeterol xinafoate 50 mcg/Respirent Pharmaceuticals; ADVAIR DISKUS 250/50
Intervention MeSH terms: Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Eighty-two (82) subjects randomised in the studies BE250-PIVOTAL, BE250-PILOT and PK250
        were included
      
Keywords: bioequivalence; pooled analysis; salmeterol xinafoate; fluticasone propionate; ADVAIR