bioihbjkbjnl/mcl2 huggingface dataset:
Evaluating the Safety and effectivenesS in Adult KorEaN Patients Treated With Tolvaptan for Management of Autosomal domInAnt poLycystic Kidney Disease
Condition: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the safety and therapeutic effectiveness of tolvaptan when administered to slow
      the progression of cyst development and renal function insufficiency in adult Korean patients
      diagnosed with rapidly progressive ADPKD who have chronic kidney disease (CKD) stages 1-3 at
      initiation of treatment.
    


Intervention name(s): Tolvaptan
Intervention type(s): Drug
Intervention description(s): 30mg and 15mg of Tolvaptan Tablet
Other intervention name(s): Samsca
Intervention MeSH terms: Tolvaptan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis
Condition: Osteoarthritis; Mindfulness; MBSR
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      Symptomatic osteoarthritis (OA) is the most common joint disease and the leading cause of
      disability in industrialized countries. Therapeutic approaches to prevent the development and
      progression of osteoarthritis are disappointing and very limited. New therapeutic
      alternatives seem essential to better manage his daily life. Non-drug approaches, including
      psycho-corporal approaches are increasingly used in the management of chronic pain.

      Mindfulness is a technique of attention training, which is to focus one's attention on the
      present moment and to examine the sensations that come to mind, how they appear, how they
      last time, and how they disappear.

      Regarding rheumatological pathologies, a Mindfulness Program (MBSR) has shown its
      effectiveness in chronic pain; and in particular in osteo-articular localization, such as
      chronic low back pain. A recent study found a correlation between a pre-disposition to
      mindfulness and less pain and / or better quality of life in patients with knee
      osteoarthritis. However, to the knowledge of investigator, no study has evaluated the
      effectiveness of an intervention based on a mindfulness training program as a therapeutic
      alternative in osteoarthritis of the knee or hip.

      The goal of investigator is to evaluate, using a randomized, controlled study, the effect of
      a mindfulness program (according to the MBSR protocol) on pain, function, psychological state
      and quality of life patients with knee or hip osteoarthritis
    


Intervention name(s): Mindfluness and usual care; Usual care
Intervention type(s): Other; Other
Intervention description(s): Intervention based on a mindfulness training program as a therapeutic alternative in osteoarthritis of the knee or hip. Mindfulness is a technique of attention training, which is to focus one's attention on the present moment and to examine the sensations that come to mind, how they appear, how they last time, and how they disappear.; No intervention on the patients
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Osteoarthritis; Mindfulness; MBSR
Ranibizumab for the Inhibition of Neovascularization in the Cornea Following Corneal Transplant Surgery
Condition: Corneal Neovascularization
MeSH terms: Corneal Neovascularization; Neovascularization, Pathologic
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this trial is to evaluate the safety and tolerability of ranibizumab
      given via subconjunctival injection in patients undergoing corneal transplantation.
    

Detailed description: 
      As a secondary objective, this study also aims to establish the corneal and anterior chamber
      concentration of ranibizumab when delivered subconjunctivally at the limbus in patients
      undergoing corneal transplantation. The effects of ranibizumab on corneal epithelial healing
      will be examined following adjunctive use in corneal transplantation. Finally, clinical
      characteristics including recurrent corneal neovascularization will be studied.
    

Intervention name(s): Ranibizumab
Intervention type(s): Drug
Intervention description(s): 0.5mg subconjunctival dose of ranibizumab 3 days prior to corneal transplantation and at the time of corneal transplantation (total 2 injections).
Other intervention name(s): Lucentis
Intervention MeSH terms: Ranibizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Corneal neovascularization; Ranibizumab; Corneal transplantation
Effect of Pulpotomy Using TheraCal Versus MTA on Survival Rate of Cariously-Exposed Vital Permanent Molars
Condition: Caries, Dental
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      Objective:

      To assess which is the most efficient pulpotomy medicament on tooth survival in patients with
      a cariously-exposed vital young permanent molar regarding: absence of postoperative pain,
      sinus or swelling, internal/ external root resorption, periapical radiolucency), root
      maturation and decrease chair side time of treated patient.

      Trial design Randomized Clinical Trial (RCT), double-blinded with parallel group and
      allocation ratio (1:1), equivalence framework.
    

Detailed description: 
      Preoperative records will be taken (photos, conventional periapical radiographs, and
      impression to construct acrylic stent to help standardization on follow up apical
      radiographs). Administration of inferior alveolar nerve block then using rubber dam isolation
      one of the investigators will remove the caries using large round but under copious amount of
      coolant and if carious exposure occur, part of the pulp chamber will be removed using sharp
      spoon excavator. Then the pulp status will be assessed if bleeding is controlled with direct
      irrigation with distilled water for 2 minutes then next step will be taken but if not
      continue excavation of the pulp till bleeding is controlled. if bleeding is not controlled
      after performing complete pulpotomy, tooth will be excluded from the study Then direct
      application of capping materials (TheraCal or MTA) according to manufacturer instructions,
      then Riva self-cure glass-ionomer base and composite resin final restoration. One of the
      investigators will take immediate standardized postoperative periapical radiographs.
      Follow-up will be for 12 months. Pre-calibrated blinded dentists will assess out comes
      separately.
    

Intervention name(s): MTA-Anglus; TheraCal
Intervention type(s): Drug; Drug
Intervention description(s): MTA-Anglus freshly mixed according to manufacturer instructions over glass slap and applied to pulp stump and application of wet cotton for 15 min. till initial setting occur.; TheraCal directly applied from the syringe container tip to pulp stump over incremental layers each layer should not exceed 1 mm thickness and each layer will be light cured for 20 sec.
Other intervention name(s): MTA-Anglus vital pulp therapy; TheraCal vital pulp therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pulpotomy; deep caries; permanent molars; MTA
Nalmefene Smoking Cessation Study
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine if nalmefene is safe and effective in smoking cessation.
    

Detailed description: 
      Single centered, randomized, placebo-controlled,double-blind, outpatient pilot study to
      evaluate the efficacy, safety and tolerability of 2 doses of nalmefene on smoking cessation.
    

Intervention name(s): nalmefene; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Nalmefene HCl film-coated tablets administered orally, twice daily, for total daily dosage of 40 or 80 mg, for 5 weeks (following a 2-week titration period).; Placebo tablets, administered orally, twice daily for 5 weeks (following a 2-week titration period).
Intervention MeSH terms: Nalmefene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of Efficacy and Safety of BF-200 ALA Used With Photodynamic Therapy in Patients With Actinic Keratosis.
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study was to evaluate the efficacy and safety of BF-200 ALA (Ameluz) used with
      photodynamic therapy (PDT) in patients suffering from actinic keratosis.
    

Detailed description: 
      The treatment comprised of one PDT session. If 12 weeks after PDT all lesions were cleared
      the patient entered the follow-up period. In case of remaining lesions or not completely
      cleared lesions the patient received a second PDT on the same day. The final assessment was
      performed 12 weeks after the last PDT and the patient moved to the follow-up phase.
    

Intervention name(s): Vehicle; BF-200 ALA
Intervention type(s): Drug; Drug
Intervention description(s): topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation).; topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation).
Other intervention name(s): Ameluz
Intervention MeSH terms: Aminolevulinic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Linking Hospitalized Injection Drug Users to Buprenorphine
Condition: Opiate Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study tests whether starting Suboxone (buprenorphine) during a medical hospitalization,
      and then providing an appointment (a "link") for after discharge to maintenance buprenorphine
      in an outpatient setting will reduce HIV risk behavior in individuals who inject opioids.
    

Detailed description: 
      In this randomized controlled trial, medically hospitalized opioid dependent patients will be
      assigned to a "treatment as usual" group, where they will receive a detox regiment of
      Suboxone during their hospital stay, or a "linkage" group, where they receive a maintenance
      course of Suboxone during their hospital stay, and appointment post-discharge with an
      outpatient Suboxone clinic/provider and a Suboxone prescription to use between discharge and
      this appointment. Study interviews are completed at baseline, and 1, 3- and 6-months
      post-baseline. Primary outcomes are opioid use and HIV risk behavior.
    

Intervention name(s): Linkage
Intervention type(s): Behavioral
Intervention description(s): This intervention provides an outpatient appointment with a Suboxone provider for medically hospitalized opioid-dependent patients to attend post-discharge.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: opioid dependence; suboxone; HIV risk behavior
Safety and Efficacy Study of Nitazoxanide in the Treatment of Acute Uncomplicated Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a randomized clinical trial designed to evaluate the safety/efficacy of two dosing
      regimens of oral nitazoxanide compared to placebo in the treatment of acute uncomplicated
      influenza in adults and adolescents. The investigators hypothesize that treatment with
      Nitazoxanide will reduce the duration of symptoms in patients with confirmed influenza
      infection. Secondarily, the investigators hypothesize that treatment with nitazoxanide will
      reduce the complications of influenza, severity of symptoms, time lost from work, time to
      return to normal daily activities.
    

Detailed description: 
      A Randomized, Double-Blind, Placebo Controlled Study of Nitazoxanide in Adults and
      Adolescents with Acute Uncomplicated Influenza. The primary objectives of this study are to
      demonstrate the efficacy of nitazoxanide administered 300 mg two times per day for 5 days or
      600 mg two times per day for 5 days in reducing the time to resolution of all clinical
      symptoms of influenza.

      The study will also evaluate pharmacokinetics of nitazoxanide in a subset of 24 patients and
      the safety of the nitazoxanide regimen compared to a placebo via analysis of adverse events
      and laboratory safety tests.

      Blood samples will be collected for all patients at baseline, day 7 and day 28, and for a
      subset of 24 patients aged 18-65 years (pharmacokinetics subset) on day 2. Urine samples will
      be collected at baseline and day 7. Nasal swabs will be collected at baseline and day 7 for
      all patients and on days 2, 3, 4 and 5 for a subset of patients (approximately 20% of
      patients).
    

Intervention name(s): Nitazoxanide; Nitazoxanide; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets, 300 mg (one 300 mg tablet + 1 placebo tablet) with food twice daily for 5 days; Tablets, 600 mg (two 300 mg tablets) with food twice daily for 5 days; Tablets, (2 tablets) twice daily with food for 5 days
Other intervention name(s): Alinia, NTZ; Alinia, NTZ; Sugar pill
Intervention MeSH terms: Nitazoxanide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: influenza
An Effectiveness Study of Paromomycin IM Injection (PMIM) for the Treatment of Visceral Leishmaniasis (VL) in Bangladesh
Condition: Visceral Leishmaniasis
MeSH terms: Leishmaniasis; Leishmaniasis, Visceral
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effectiveness of treatment with PMIM in patients
      with visceral leishmaniasis within the VL-endemic region of Bangladesh at EOT (21/22 days
      after treatment begins), and at 6 months after end of treatment (Day 202/203, -15 to +30
      days).
    

Detailed description: 
      Safe, effective and affordable treatments for visceral leishmaniasis (VL) that are widely
      available to the poorest populations are urgently needed in Bangladesh in areas where the
      disease is endemic. Paromomycin IM Injection (PMIM) was approved for the treatment of VL in
      August 2006 by the Drugs Controller General of India (DCGI), and it offers an attractive
      alternative to treatments that are currently available.
    

Intervention name(s): Paromomycin sulfate
Intervention type(s): Drug
Intervention description(s): Paromomycin IM Injection, 11 mg/kg as the base, intramuscular, once a day on 21 consecutive days (or no more than 22 days if one injection is missed during the treatment period).
Other intervention name(s): aminosidin sulfate; aminosidine sulfate; monomycin A sulfate; amminosidin sulfate; catenulin sulfate; crestomycin sulfate; estomycin sulfate; hydroxymycin sulfate; neomycin E sulfate; paucimycin sulfate; Humatin®; Gabbromicina®; Gabromicina®; Gabromycin®; Gabboral®; Kapseal®; Pargonyl
Intervention MeSH terms: Paromomycin; Neomycin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Leishmaniasis, Visceral; kala-azar; Paromomycin; Bangladesh; Injections, Intramuscular; Treatment Outcome; Patient compliance; Medication adherence; Drug toxicity
Autologous Myoblast Intrasphincteric Injection for Fecal Incontinence
Condition: Fecal Incontinence
MeSH terms: Fecal Incontinence
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This project aims to offer autologous muscle-derived progenitor cell injection as an
      efficient mini-invasive surgical therapy that would be simple for the patient and could be
      used in a majority of cases, including in young women in the post-partum. This approach may
      provide efficient tissue repair of the striated anal sphincter which is not permitted by
      existing therapies. This innovative therapy may ultimately be proposed after failure of the
      common treatments and before an high-risk invasive surgical intervention. Besides, injection
      of muscle-derived progenitor cells in animals has shown very encouraging results of the
      sphincter function assessed ex vivo. Hence, a high benefit may be expected with this
      approach.
    

Detailed description: 
      after verification of information and inclusion criteria. patients were randomized to
      treatment or placebo arms and receive the injections.

      an evaluation of the function and quality of life are realized. after a period of 6 months,
      patients in the placebo arm receive the injection of myoblasts that have been preserved.
    

Intervention name(s): Myoblast injection; saline solution injection
Intervention type(s): Other; Procedure
Intervention description(s): Autologous myoblast injection in the anal sphincter; saline solution injection in anal sphincter
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fecal incontinence; Myoblast; Surgery
Anterior Cruciate Ligament-reconstruction: Quadriceps Tendon or Hamstrings Tendon? A Prospective Trial
Condition: Ligament; Laxity, Knee; Rupture of Anterior Cruciate Ligament
MeSH terms: Rupture
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether there is a difference in muscle strength
      after anterior cruciate ligament comparing 2 surgery technics. Using either autograft
      hamstrings tendon or a autograft quadriceps tendon.
    


Intervention name(s): Quadriceps graft
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Combination Therapy With NC-6004 and Gemcitabine Versus Gemcitabine Alone in Pancreatic Cancer
Condition: Pancreatic Neoplasms
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This clinical trial is designed to evaluate the impact of the addition of NC-6004 to
      gemcitabine in the treatment of patients with locally advanced or metastatic pancreatic
      cancer in Asian countries.
    

Detailed description: 
      Pancreatic cancer is one of the most deadly cancers because of the predominately late
      diagnosis. Gemcitabine (GEM) is the standard treatment for advanced and metastatic pancreatic
      cancer. According to preclinical data and few early phase studies, a combined use of
      gemcitabine and cisplatin (CDDP) showed synergistic efficacy against pancreatic cancer.
      NC-6004, a novel micellar cisplatin formulation, retains the activity but avoids the renal
      toxicity and neurotoxicity caused by the high peak Cmax concentrations of cisplatin. This
      trial is designed to evaluate the impact of the addition of NC-6004 to gemcitabine in the
      treatment of patients with locally advanced or metastatic pancreatic cancer.

      The main hypothesis of this study is that NC-6004 plus gemcitabine combination is superior to
      gemcitabine alone in terms of overall survival in locally advanced or metastatic pancreatic
      cancer patients
    

Intervention name(s): NC-6004; Gemcitabine
Intervention type(s): Drug; Drug
Intervention description(s): Study group (3 week/cycle):
NC-6004 90 mg/m2 i.v. inf. over 60 min on Day 1; Study group (3 week/cycle):
Gemcitabine 1000 mg/m2 i.v. inf. over 30 min on Day 1 and Day 8 (follow by administration of NC-6004)
Control group (4 week/cycle):
Gemcitabine 1000 mg/m2 i.v. inf. over 30 min on Day 1, Day 8 and Day 15
Other intervention name(s): Micelplatin; Gemzar
Intervention MeSH terms: Gemcitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pancreatic cancer; Platinum; Micelle
Autologous Stem Cell and Hyperbaric Oxygen Therapy in Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A prospective, open labeled, randomized controlled clinical trial comparing the benefit of
      both hyperbaric oxygen therapy and intrapancreatic stem cell infusion to standard medical
      treatment alone for type 2 diabetes mellitus. Subjects will receive standard medical
      treatment (SMT) with insulin and metformin for 4 months (evaluation phase). Then they will be
      randomized into either the intervention group or the control group:
    

Detailed description: 
      This is a phase I/II, prospective, randomized case controlled study in patients with Type 2
      Diabetes Mellitus (T2DM) that seeks to investigate whether the combination of intrapancreatic
      Autologous Stem Cell infusion (ASC) and Hyperbaric Oxygen treatment (HBO) can improve
      glycemic control and pancreatic function in T2DM patients compared to controls receiving
      standard medical treatment (SMT) with metformin and insulin alone.

      New therapies that lead to stopping ß-cell damage and possible ß-cell regeneration may
      decrease the incidence and progression of T2DM chronic complications and together with
      achievable life style changes may improve general health and quality of life of T2DM
      patients. Preliminary data from a pilot study involving 25 subjects with T2DM that underwent
      a combined treatment using ASC+HBO showed a significant progressive and consistent reduction
      in plasma glucose and HbA1c with an increase in C-peptide in conjunction with a decrease in
      the number and dose of oral agents and/or insulin. These encouraging preliminary results
      require confirmation in a controlled, randomized prospective trial.
    

Intervention name(s): Autologous stem cells; Hyperbaric oxygen therapy; Insulin; Metformin
Intervention type(s): Biological; Other; Drug; Drug
Intervention description(s): Pancreatic artery infusion of Autologous Stem cells.; Insulin dose as per clinical management; Metformin dose as tolerated
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Type 2 Diabetes Mellitus; Hyperbaric oxygen therapy (HOT); Autologous Bone Marrow-Derived Buffy Coat; Stem cells (SC)
A Study to Compare the Pharmacokinetics of YM150 Formulation-A and Formulation-B
Condition: Healthy Volunteer; Pharmacokinetics of YM150
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to compare its pharmacokinetics profile of two YM150 formulations by 2x2
      crossover method.
    


Intervention name(s): YM150
Intervention type(s): Drug
Intervention description(s): oral
Intervention MeSH terms: Darexaban
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: YM150; bioequivalence study