bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Fimasartan Alone or Combined With HCTZ in Mexican Patients With Essential Hypertension
Condition: Hypertension, Essential
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      Fimasartan (FMS) is an AT1 receptor antagonist indicated for once a day administration,
      currently approved for the treatment of essential hypertension in Corea and Mexico. As the
      safety and efficacy of FMS was initially demonstrated in Korea only, it was necessary to
      address the potential for ethnic factors to have an effect on the drug´s efficacy and safety
      in the Mexican population. To address this need, a cohort of 272 Mexican subjects with grades
      1-2 essential hypertension were sequentially treated on a treat to target basis (target:
      sitting Diastolic Blood Pressure (sDBP) <90 mmHg) with 60 mg FMS once a day (8 weeks), either
      120 mg FMS or 60 mg FMS+12.5 mg HCTZ once a day (randomized 4 week treatment period) and 120
      mg FMS once a day (during 12 weeks) for a total treatment period of 24 weeks.
    

Detailed description: 
      This was a prospective, open, multicentre, 24 week study of subjects with grade 1-2 essential
      hypertension eligible, according to the participating investigator's clinical judgement, to
      initial monotherapy.

      Consenting, eligible subjects at 13 Mexican participating centers were initially assigned to
      monotherapy with 60 mg FMS once a day. At treatment week 8, those subjects with a sDBP ≥90
      mmHg were randomized to either 120 mg FMS or to 60 mg FMS + 12.5 mg hydrochlorothiazide
      (HCTZ) once a day during 4 weeks. At treatment week 12, all non-responding subjects were
      finally assigned to 120 mg FMS + 12.5 mg HCTZ for the remaining 12 weeks of the planned 24
      week treatment period. At treatment weeks 8 and 12, those subjects with a sDBP < 90 mmHg
      remained on their assigned treatment for the rest of the study.

      This cohort study was designed to collect information on treatment effect (blood pressure
      changes from baseline/reference time and treatment response rates), and safety (i.e.,
      incidence and characterization of clinical, laboratory and ECG adverse events); accordingly,
      subjects were assessed at treatment weeks 4, 8, 12, 16, 20 and 24 in terms of vital signs,
      clinical laboratory safety parameters, concomitant medications and adverse events. 12-lead
      ECG recordings were obtained from all subjects both at screening and at treatment week 24 and
      a subset of 11 subjects underwent both baseline and treatment week 8 24-hour ABPM recordings.
    

Intervention name(s): Fimasartan; Fimasartan; Hydrochlorothiazide
Intervention type(s): Drug; Drug
Intervention description(s): Fimasartan tablets; Fimasartan plus hydrochlorothiazide fixed dose combination tablets
Other intervention name(s): Arakhor; Kanarb; Diarakhor; Kanarb plus
Intervention MeSH terms: Hydrochlorothiazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Functional Imaging and Reading Deficit in Children With NF1
Condition: Neurofibromatosis Type 1
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma
Study type: Interventional

Summary: 
      A monocenter pilot study on the acceptability and feasibility of a functional MRI protocol in
      children with NF1 with or without reading disabilities.
    

Detailed description: 
      The principal aim of the study is to highlight the activation of brain area involved
      phonological and visuo-spatial processing in children with NF1 with or without reading
      disabilities.
    

Intervention name(s): Neuropsychological assessments; morphological and functional MRI (fMRI); genetic analysis
Intervention type(s): Other; Radiation; Genetic
Intervention description(s): IQ (WISC-IV)
Reading tests (reading accuracy, reading speed, reading comprehension and strategy):
Alouette, Lobrot, Odedys tests. Visuo-spatial skill (JLO, Thurston, CORSI tests) Attention (CPT 2, CBCL) Receptive oral language (EVIP); The fMRI will consider on the acquisition of a 3D anatomical sequence in T1 high resolution in axial slices of 1mm with an acquisition time of 10 min and a T2 sequence and a "Flair" to allow UBO location.; Blood collection in 3 tubes (2 PAXgen® and 1 EDTA) and analysis to study the NF1 gene deletion.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: NF1; Children; Reading disability; Morphological and functional MRI; Genetic analysis
Medium Term Outcome of Nonoperative Treatment After Achilles Tendon Rupture.
Condition: Achilles Tendon Rupture
MeSH terms: Rupture
Study type: Observational

Summary: 
      A total of 56 patients completed a previous study regarding non-operative treatment for acute
      achilles tendon rupture. This study consists of an additional follow up after 4-5 years
      depending on original date of injury.
    

Detailed description: 
      30 patients suffering from acute Achilles tendon rupture was originally randomized to each
      arm, and followed up after 6 and 12 months. Of these a total of 56 patients was included in
      the final analysis, and invited to participate in this additional follow-up, 4-5 years after
      their original injury. Originally patients was monitored using: ATRS questionnaires, ATRA:
      Achilles Tendon Resting Angle, Heel Raise Work: number of lifts, lift height and total work,
      and tests of strength and stiffness in the ankle using a kinetic dynamometer.
    

Intervention name(s): Early weight bearing
Intervention type(s): Behavioral
Intervention description(s): The intervention implies that the selected patients, will be allowed to bear weight on the injured leg form day 1 while wearing the orthosis, in contrast to the control group, who must wait 6 weaks.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients who participated and completed the original study:

        Barfod, K.W., et al., Nonoperative dynamic treatment of acute achilles tendon rupture: the
        influence of early weight-bearing on clinical outcome: a blinded, randomized controlled
        trial. J Bone Joint Surg Am, 2014. 96(18): p. 1497-503.
      
Keywords: Achilles Tendon Rupture; Conservative treatment; early weight bearing; Dynamic; ATRS; ATRA; Heel Raise Work
Safety and Pharmacokinetics of Recombinant Factor XIII Administration in Healthy Volunteers
Condition: Congenital Bleeding Disorder; Congenital FXIII Deficiency; Healthy
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial was conducted in Europe. The aim of this trial was to investigate safety and
      pharmacokinetics of multiple doses of catridecacog (recombinant factor XIII, rFXIII) in
      healthy volunteers.
    


Intervention name(s): catridecacog; placebo
Intervention type(s): Drug; Drug
Intervention description(s): For 5 consecutive days, one daily dose of rFXIII was administered intravenously (IV) to eight subjects in each dose group (10 or 25 U/kg).; For 5 consecutive days, one daily dose of placebo was administered intravenously (IV) to two subjects in each dose group (10 or 25 U/kg).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Botulinum Toxin Type A Block of the Otic Ganglion in Chronic Cluster Headache: Safety Issues
Condition: Cluster Headache
MeSH terms: Ganglion Cysts; Cluster Headache; Headache
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Cluster headache (CH) is the most common of the trigeminal autonomic cephalalgias and one of
      the most severe pains known to man, having a large impact on the sufferer's quality of life.
      A parasympathetic dysfunction in CH has been suggested. The sphenopalatine ganglion has been
      a target for treatment of primary headache disorders for more than a century but there are
      several anatomic and physiologic studies that suggest that another cranial parasympathetic
      ganglion, the otic ganglion (OG), might be also relevant in CH. In this study OG will be
      blocked with botulinum toxin type A in a pilot study in 10 patients with chronic cluster
      headache. Recruitment of patients will be solely in Norway. There is no data available to
      determine the correct dosage of botulinum toxin. A similar neural structure that has been
      blocked with botulinum toxin in humans is the sphenopalatine ganglion. The investigators
      injected 10 patients suffering from intractable chronic cluster headache with botulinum toxin
      in the sphenopalatine ganglion. 5 patients were given 25 IU and 5 patients were given 50 IU.
      Even though the number of treated patients is low, there did not appear to be differences in
      the adverse events profile between those who received 25 Iu and those who received 50 IU. The
      investigators also previously injected 25 IU botulinum toxin towards the sphenopalatine
      ganglion bilaterally (i.e. 25 IU in each side) in 10 patients suffering from intractable
      chronic migraine. Doses of up to 25 IU have been injected in structures adjacent to the otic
      ganglion, for instance in dystonia towards the lateral pterygoid muscle. Thus it was decided
      for this study on injection towards the otic ganglion, to explore the safety of 12.5 and 25
      IU of botulinum toxin.
    


Intervention name(s): Botulinum Toxin Type A 25 IU; Botulinum Toxin Type A 12.5 IU
Intervention type(s): Drug; Drug
Intervention description(s): injection with 25 IU botulinum toxin towards the otic ganglion (symptomatic side) using image-guided navigation and the MultiGuide device; injection with 12.5 IU botulinum toxin towards the otic ganglion (symptomatic side) using image-guided navigation and the MultiGuide device
Other intervention name(s): Botox; BTA; Allergan; Botox; BTA; Allergan
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nerve block; Ganglia, Parasympathetic; Botulinum Toxins, Type A; Injection
Administration of a Bitter-Tasting Medication: Comparison Between the Rx Medibottle and the Oral Syringe
Condition: Infant Acceptance of Medication
Study type: Interventional

Summary: 
      Hypothesis: The Rx medibottle is more effective than the oral syringe when giving infants
      less than 2 years of age a bitter-tasting medication (prednisolone syrup).

      Summary: Infants who were admitted to the pediatric floor with a respiratory illness at the
      Bronx-Lebanon Hospital were offered the chance to take part in the study. If these children
      needed prednisolone syrup for their treatment, were less than 2 years old and were
      bottle-fed, and were in stable condition, they qualified. They were randomly assigned (just
      by chance), into a control arm, where they received medication using the oral syringe, or an
      intervention arm, where they were given medication using the Rx medibottle. How well the
      infant accepted the bitter-tasting medication was compared between the two arms using an
      infant medication acceptance scale. The scale was administered and a score generated by two
      raters: the nurse who administered the medication, and a child life therapist who witnessed
      the administration. The time needed to give the medication, the drug delivery device's
      ability to administer the entire dose of medication and the mother's satisfaction with the
      method used were also compared between the two arms.
    

Detailed description: 
      The ability to deliver drugs to infants and children safely and accurately has long been of
      concern to pediatricians and caregivers. Calibrated oral syringes are accurate in measuring
      and delivering the required dose, have minimal potential for spillage and are considered the
      standard drug delivery system for this population. However, infant acceptance of the syringe
      may not always be favorable. The objective of this study was to compare the Rx medibottle to
      the oral syringe when used to administer liquid medication to infants. It is a prospective,
      controlled trial that enrolled infants <2 years of age admitted to a community hospital in
      the Bronx, who were prescribed a daily dose of 2 mg/kg of prednisolone syrup (15 mg/5 ml) for
      a respiratory illness. Participants were randomly assigned to receive one dose of
      prednisolone syrup using the Rx medibottle (intervention arm) or the oral syringe (control
      arm). The infant medication acceptance scale (MAS) used to evaluate acceptance by the infants
      was developed and validated by Donna Kraus, Leslie Stohlmeyer and Patricia Hannon and
      published in the American Journal of Health-System Pharmacy (1999;16:1094-1101).
    

Intervention name(s): Rx Medibottle
Intervention type(s): Device
Intervention description(s): Comparing use of the Rx medibottle to the oral syringe in delivering a one-time dose of prednisolone syrup
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Rx medibottle; Oral syringe; Liquid medication; Bitter-tasting; Infants
Adjuvant Oxytocin for Preinduction Ripening With a Foley catheter--a Clinical Trial
Condition: Pregnancy; Induced Labor; Cervical Ripening
Study type: Interventional

Summary: 
      The transcervical Foley catheter (TFC) is a proven and effective mode of cervical ripening.
      It is common practice to use TFC with simultaneous low-dose oxytocin under the assumption
      that the combination results in a more successful labor induction. Scientific validation of
      this practice is lacking. We seek to determine if the addition of oxytocin to TFC improves
      induction success.
    

Detailed description: 
      This is a prospective, randomized trial that aims to enroll 200 singleton pregnancies
      presenting for preinduction ripening. Patients will be randomized to receive either TFC alone
      (control) or TFC plus low-dose oxytocin (treatment). Providers will not blinded to use of
      oxytocin and labor was managed according to routine obstetric protocols. This study is
      powered to detect a 20% difference in the proportion of patients delivered within 24 hours,
      the primary outcome. Secondary outcomes are related to vaginal delivery rate, duration of
      induction, complications, and pain management.
    

Intervention name(s): low dose oxytocin
Intervention type(s): Drug
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: induction of labor; cervical ripening; Foley catheter; oxytocin
Autologous BMNC Infusion for Liver Cirrhosis in Children With BA
Condition: Biliary Atresia
MeSH terms: Liver Cirrhosis; Biliary Atresia
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and early outcomes of autologous bone marrow mononuclear cell (BMMNC)
      infusion for liver cirrhosis due to biliary atresia (BA) after Kasai operation. An open-label
      clinical trial was performed from January 2015 to December 2021. 12 children with liver
      cirrhosis due to BA at the time of Kasai or after Kasai were included. Bone marrow was
      harvested through anterior iliac crest puncture under general anesthesia. Mononuclear cells
      (MNCs) were isolated by Ficoll gradient centrifugation and then infused into the hepatic
      artery.
    

Detailed description: 
      Biliary atresia (BA) is a progressive fibro-obliterative cholangiopathy and a fatal disease.
      Without surgery, children with BA rarely survive beyond three years of age. The reported
      prevalence of BA ranges from 1 in 9640 to 1 in 19,500 live births. In the past, most children
      with a "non-correctable" type of BA died without adequate treatment. Recently, stem cell
      administration has been applied in adults with liver cirrhosis and has shown promising
      outcomes. An open-label clinical trial was performed from January 2015 to December 2021. 12
      children with liver cirrhosis due to BA at the time of Kasai or after Kasai were included.
      Bone marrow was harvested through anterior iliac crest puncture under general anesthesia.
      Mononuclear cells (MNCs) were isolated by Ficoll gradient centrifugation and then infused
      into the hepatic artery. Serum bilirubin, albumin, alanine aminotransferase, aspartate
      aminotransferase, gamma-glutamyl transferase, and prothrombin time were monitored at
      baseline, three months, six months and 12 months after the transplantation. Esophagoscopies
      and liver biopsies were performed in patients whose parents provided consent. This study
      aimed to evaluate both safety and hepatic function after BMMNC administration in these
      children.
    

Intervention name(s): Autologous BMMC transplantation
Intervention type(s): Combination Product
Intervention description(s): One administration of autologous bone marrow mononuclear cells via the hepatic artery
Intervention model: Single Group Assignment
Intervention model description: Autologous BMMC infusion
Masking: None (Open Label)
Primary purpose: Treatment
to Evaluate the Efficacy and Safety of MG4101(Ex Vivo Expanded Allogeneic NK Cell)
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2

Summary: 
      To see the safety and efficacy of injecting MG4101 as a secondary treatment after curative
      liver resection on the patient with advanced HCC who has high risk of recurrence.
    

Detailed description: 
      To see the safety and efficacy of injecting MG4101(Ex vivo expanded allogeneic NK cell) as a
      secondary treatment after curative liver resection on the patient with advanced HCC who has
      high risk of recurrence.
    

Intervention name(s): MG4101
Intervention type(s): Biological
Intervention description(s): Ex vivo expanded allogeneic NK cell
Other intervention name(s): NK cell
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NKCELL
Docetaxel Plus Cisplatin Followed by Gemcitabine Versus Gemcitabine Plus Cisplatin Followed by Docetaxel for Non-Small Cell Lung Cancer (NSCLC)
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the 1-year treatment failure rate of two sequential
      chemotherapy regimens: weekly docetaxel plus cisplatin followed by gemcitabine; and
      gemcitabine plus cisplatin followed by weekly docetaxel。
    

Detailed description: 
      Lung cancer is the leading cause of cancer death in men and women worldwide. Shifting trends
      in the incidence of lung cancer closely follow the patterns of cigarette smoking, although
      other carcinogens have been implicated. Despite intensive treatment over the past several
      decades, the 5-year lung-cancer survival rate remains a dismal 8-14%.

      Chemotherapy is the primary therapy to patients with stage IIIB/IV disease, and most
      investigators believe that treatment with a combination of two agents is the best first-line
      treatment for stage IV NSCLC. In the late 1970s and 1980s, studies were conducted using
      combinations of agents. Outcomes were improved and these agents were eventually incorporated
      into clinical practice.

      Weekly docetaxel is being studied in combination with other commonly used NSCLC
      chemotherapeutic agents including carboplatin, navelbine, and gemcitabine. These combinations
      are being studied in both first- and second-line settings. Second line chemotherapy with
      docetaxel may affect survival (TAX 318, 1 year survival 37% vs. 11%). However, the optimal
      sequence of chemotherapy was rarely explored. Weekly docetaxel may offer better tolerability
      vs. 3-weekly schedule when combining docetaxel to cisplatin. Based upon these studied, we
      choose weekly docetaxel in combination with cisplatin as our regimen. We expected the regimen
      would be effective and well tolerated.
    

Intervention name(s): Docetaxel, Cisplatin; Gemcitabine, Cisplatin
Intervention type(s): Drug; Drug
Intervention description(s): docetaxel 36mg/m2 IF 30 mins on day 1,8,15 cisplatin 75mg/m2 IF 2 hrs on day 15; gemcitabine 1000mg/m2 IF 30mins on D 1,8,15, cisplatin 75mg/m2 IF 2 hrs on day 15
Intervention MeSH terms: Cisplatin; Gemcitabine; Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Combination, Chemotherapy,non-small cell lung cancer
A Device Study for the Treatment of Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      To evaluate the safety and efficacy of the Cutera laser system for the treatment of acne
      vulgaris.
    


Intervention name(s): Cutera Laser System
Intervention type(s): Device
Intervention description(s): Subjects will receive laser treatments
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Soluble Guanylate Cyclase (sGC) Stimulator IW-1973 in Diabetic Nephropathy / Diabetic Kidney Disease as Measured by Albuminuria
Condition: Type 2 Diabetes Mellitus With Diabetic Nephropathy
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Albuminuria; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the safety and efficacy of IW-1973 in patients with type 2 diabetes mellitus with
      albuminuria who are on a stable regimen of renin-angiotensin system inhibitors.
    


Intervention name(s): IW-1973; IW-1973; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral Tablet; Oral Tablet; Oral Tablet
Intervention MeSH terms: Praliciguat
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Phase 2, randomized, double-blind, placebo-controlled, parallel-group study
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Clinical Trial Based on the Use of Mesenchymal Stem Cells From Autologous Bone Marrow in Patients With Lumbar Intervertebral Degenerative Disc Disease
Condition: Intervertebral Disc Disease
MeSH terms: Spinal Diseases; Intervertebral Disc Degeneration
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this trial is to test the effectiveness of the use of a new therapeutic
      strategy in treating patients with degenerative disc disease lumbar intervertebral fusion
      with instrumented posterolateral autologous mesenchymal stem cells and arranged in a calcium
      phosphate ceramic (Conduit TM).
    


Intervention name(s): Instrumented posterolateral arthrodesis
Intervention type(s): Procedure
Intervention description(s): Cell suspension of mesenchymal stem cells (MSCs) obtained from bone marrow aspirate from the patient and expanded in vitro in a specific medium enriched with platelet lysate without addition of animal products.
They used a minimum dose of 0.5 x106 CSM / kg and a maximum of 1, 5x106 CSM / kg of patient weight.
Dosage Form: Suspension cell support hydroxyapatite and calcium phosphate Route of administration: placement in the fusion bed during surgery.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mesenchymal Stem Cells; Stem Cells; Intervertebral disc disease