bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Rocker sOles in Diabetis
Condition: Diabetic Neuropathy
MeSH terms: Diabetic Neuropathies
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if the wearing of shoes "rocker sole" type
      prescribed in type 2 diabetics patients with neuropathy are responsible for disorders of
      equilibrium.
    

Detailed description: 
      Diabetes is a public health problem. The functional prognosis is partly conditioned by the
      occurrence of wounds at the level of the foot affected by neuropathy and/or arteriopathy.
      Preventive measures are necessary to avoid such complications: education, pedicure, suitable
      footwear, insoles. There are many types of orthopedic shoes, standard or custom-made. A key
      objective is to avoid excessive pressure found at the level of the front-foot, favoring the
      appearance of lesions like ulcers. In this context, the Anglo-Saxons have developed a type of
      shoe ( "rocker sole"), allowing to decrease the pressures on the front-foot with a rigid sole
      system associated with an elevation of the front-foot. Some, however, have shown that this
      type of shoe may be responsible for disorders of equilibrium to the healthy subject, what
      about at the diabetic patients, already at higher risk of postural disorders and falls?
    

Intervention name(s): Rocker sole shoes; Normal shoes
Intervention type(s): Device; Device
Intervention description(s): Measure of walk testing Measure of standing position; Measure of walk testing Measure of standing position
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 diabetes; Diabetic neuropathy; Disorders of equilibrium; "Rocker sole" shoes; Walking
Prosthetic Pelvic Organ Prolapse Repair
Condition: Cystocele
MeSH terms: Cystocele; Prolapse; Pelvic Organ Prolapse
Study type: Interventional

Summary: 
      The cystocele is the most frequent clinical shape of the genital prolapse. It is a frequent
      pathology in woman which can impair quality of life and generates pelvic, urinary or sexual
      functional disorders.

      It's considered that 8 % of women will be undergo surgery in this indication before the age
      of 80 years. Numerous surgical techniques have been described and we distinguish the
      interventions according to the route (vaginal or abdominal), and according to the use or not
      of synthetic mesh (non-absorbable) to increase the anatomical results.
    

Detailed description: 
      This is a multicenter, randomized, comparative, 2-parallel-arm study in patients with pelvic
      organ prolapse (cystocele) Approximately 260 patients aged from 45 to 75 years will be
      allocated to have laparoscopic sacropexy or vaginal mesh surgery.
    

Intervention name(s): laparoscopic sacropexy; vaginal mesh
Intervention type(s): Procedure; Procedure
Intervention description(s): under laparoscopic vision, the vesico-vaginal space is dissected until the level of the bladder neck. a synthetic non absorbable mesh is placed between the bladder and the vagina. the mesh is sutured to the vagina and the apex (vaginal apex or uterus) and anchored to the prevertebral ligament in front of the promontorium.; after anterior sagittal colpotomy, the bladder is dissected under the fascia layer, and the paravesical fossa are entered. a synthetic non absorbable mesh is placed with 4 arms suspension (trans obturator or not). treatment of the apex is mandatory.
Other intervention name(s): laparoscopic surgery; medical vaginal device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: bladder prolapse (cystocele); Pelvic organ prolapse repair; coelioscopic; prosthetic surgery; vaginal approach; Randomized study; laparoscopic sacropexy; vaginal mesh surgery; Stage II; Clavien Dindo
Glucarpidase Effect on Severe Delayed HDM-clearance in Children Treated With High-dose Mtx in ALL
Condition: Acute Lymphoblastic Leukemia (ALL)
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 3

Summary: 
      Early intervention in children and adolescents who experience delayed MTX-clearance and renal
      dysfunction in ALL treatments with the enzyme Glucarpidase which rapidly hydrolyses MTX to
      non-toxic metabolites to avoid life threatening complications.
    

Detailed description: 
      The NOPHO ALL-2008 protocol is a treatment and research protocol that aims to improve the
      overall outcome of Nordic children and adolescents with ALL in comparison with the ALL-2000
      protocol and with the aim to reduce and prevent toxic treatment complications with high-dose
      methotrexate (HD-MTX).

      The specific and primary objectives of the randomized study is:

        1. Early intervention in children and adolescents who experience delayed MTX-clearance and
           renal dysfunction with the enzyme Glucarpidase which rapidly hydrolyses MTX to non-toxic
           metabolites and lowers the serum concentration to avoid life threatening complications.
           Glucarpidase should be given if the 24 hour levels of MTX is > 250 µM, 36 hour levels >
           30 µM or 42 hours levels > 10 µM together with a reduced kidney function. Glucarpidase
           treatment should take place within 48 hours from the start of HD-MTX treatment.

        2. To evaluate if the early intervention with Glucarpidase reduce the number of days the
           patients have to stay at the hospital.

        3. Evaluate the reduction of health costs of early intervention in patients with delayed
           MTX-clearance and renal dysfunction.
    

Intervention name(s): Glucarpidase
Intervention type(s): Drug
Intervention description(s): Patients treated with Glucarpidase if the 24 hour levels of MTX is >250 µM, 36 hour levels >30 µM or 42 hours levels >10 µM together with a reduced kidney function will be compared with patients in just below the tricking values.
Other intervention name(s): VORAXAZE®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug: Glucarpidase
A Bridging Study of FB2001 in Healthy Subjects
Condition: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      In the first human clinical trial conducted in the United States, single and multiple dosing
      of FB2001 in multiple dose groups were partially completed，and FB2001 demonstrated good
      safety and tolerability. The bridge study of FB2001 will be conducted in China to evaluated
      the safety and PK of FB2001 in healthy Chinese population. This is a randomized,
      double-blind, placebo-controlled study of single and multiple dosing.
    

Detailed description: 
      Coronaviruses belong to the genus of coronavirus of the family coronaviruses. The viruses of
      the coronavirus genus are positive-sense single-stranded RNA viruses with envelopes, which
      are approximately 80-160 nm in diameter. Their genetic material is the largest among all RNA
      viruses and can infect both humans and animals. Coronaviruses can cause respiratory,
      intestinal, hepatic, and nervous system diseases of different severities. A total of 7
      coronaviruses have been found, in which HCoV-229E, HCoV-OC43, HCoV-NL63 and HCoV-HKU1 mainly
      lead to mild and self-limiting upper respiratory tract infections in infected humans, such as
      common cold; two new types of β-coronaviruses have emerged in the past 12 years, namely
      severe acute respiratory syndrome (SARS-CoV) and Middle East respiratory syndrome (MERS-CoV),
      and these two viruses can cause severe human diseases.

      In the first human clinical trial conducted in the United States, single and multiple dosing
      of FB2001 in multiple dose groups were partially completed，and FB2001 demonstrated good
      safety and tolerability. The bridge study of FB2001 will be conducted in China to evaluated
      the safety and PK of FB2001 in healthy Chinese population. This study is a randomized,
      double-blinded, placebo-controlled, ascending dose to evaluate the pharmacokinetics, safety
      and tolerability of FB2001 for injection afer a single and multiple dose administrations in
      healthy subjects. A total of 40 healthy subjects are planned to be enrolled. Each group will
      include 8 subjects.
    

Intervention name(s): FB2001; FB2001 placebo
Intervention type(s): Drug; Other
Intervention description(s): Subjects will be administered with FB2001 by intravenous (IV) infusion; Subjects will be administered with FB2001 by intravenous (IV) infusion
Other intervention name(s): DC402234
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cardiovascular Effects of Oligomeric Procyanidins (OPCs) in Smokers
Condition: Smoking
Study type: Interventional

Summary: 
      Smoking has been identified as a key risk factor for the development of cardiovascular
      diseases (CVD). It was found that a persistent increase in levels of oxidative stress and
      prolonged inflammation play a pivotal role in the pathogenesis of smoking associated CVD.
      Oligomeric proanthocyanidins (OPCs) are widely known for their anti-oxidant and
      anti-inflammatory effects, in vitro and in vivo. However, there are hardly any studies
      available that systematically investigated their acute and long-term effects on vascular
      function as well as on established biomarkers of oxidative stress and inflammation in an "at
      risk" population such as smokers.

      Therefore, the aim of the present study is to investigate the effects of an eight-week
      supplementation with OPCs on vascular function as well as biomarkers of oxidative stress and
      inflammation in blood of smokers.
    


Intervention name(s): oligomeric proanthocyanidins (MASQUELIER'S Original OPCs); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 200 mg oligomeric proanthocyanidins (MASQUELIER'S Original OPCs) per day over 8 weeks; placebo
Intervention MeSH terms: Proanthocyanidin; Procyanidin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: smoking; oligomeric proanthocyanidins; polyphenols; supplementation; vascular function; oxidative stress; inflammation
The Role of Ghost Ileostomy in Laparoscopic Rectal Resection
Condition: Colo-rectal Anastomosis Dehiscence
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate if the Ghost Ileostomy is really advantageous in laparoscopy we conducted a
      prospective randomized controlled study comparing 2 groups of patients undergoing anterior
      resection of the rectum laparoscopically. In the first group of patients at the end of the
      procedure was always performed a Ghost Ileostomy while in the second group no protective
      stoma was built at the end of the intervention.
    


Intervention name(s): Ghost Ileostomy
Intervention type(s): Procedure
Intervention description(s): At the end of Laparoscopic Anterior Rectal Resection, once the colorectal anastomosis was performed, the terminal ileum was identified and a window in the mesentery was created to pass a rubber tube (we usually use an urinary catheter) around the intestinal loop. The tube was subsequently exteriorized trough the trocar incision in the right flank.
Other intervention name(s): Virtual Ileostomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Neurohormonal Parameters in Hypertrophic Cardiomyopathies
Condition: 1- Primary (Sarcomeric) Hypertrophic Cardiomyopathy; 2- Obstructive Hypertrophic Cardiomyopathy; 3- Non Obstructive Hypertrophic Cardiomyopathy
MeSH terms: Cardiomyopathies; Cardiomyopathy, Hypertrophic; Hypertrophy
Study type: Interventional

Summary: 
      The primary purpose of this study is to demonstrate that changes in plasma levels of
      circulating neurohormones (mainly BNP and NT-proBNP), measured at rest and post-exercise
      correlate with exercise functional limitation (assessed by exercise peak VO2) and exercise
      ultrasonic parameters (as left ventricular filling, obstruction, and mitral regurgitation)
    

Detailed description: 
      The secondary purposes are to study the kinetics of secretions of natriuretic peptides, and
      their relationships with extent of MRI myocardial fibrosis with the degree of exercise
      functional limitation.
    

Intervention name(s): blood sample collection
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 1- Hypertrophic cardiomyopathy; 2- BNP; 3- NT-proBNP; 4- Neurohormons
The Effect of Extracorporeal Shock Wave Therapy on Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The shock wave is a new and potential intervention for the reinnervation of peripheral nerve.
      The purpose of this study was to assess the effect of extracorporeal shock wave therapy on
      carpal tunnel syndrome.
    

Detailed description: 
      Recently, many studies show the potential effect of shock wave for the reinnervation for
      peripheral neuropathy in the animal mode. Only one study reveal the potential benefit of
      shock wave in patients with carpal tunnel syndrome. Althouh its expressive finding, the
      number of cases is relatively too small to make a conclusive remark. Large and well-designed
      study would expand the new field.
    

Intervention name(s): Shock wave
Intervention type(s): Device
Intervention description(s): Shock waves are defined a sequence of acoustic pulse characterized by a high peak pressure (100 MPa), fast pressure rise (< 10 ns) and short duration (10 μs). Different studies and clinical experiments have demonstrated the efficacy of shock waves in the treatment of musculoskeletal system such as chronic tendinopathies or hypertrophic pseudoarthrosis
Other intervention name(s): E-SWT, Elettronica Pagani, Italy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: shock wave; carpal tunnel syndrome
Efficacy of Pioglitazone in Participants With Inadequately Controlled Type 2 Diabetes Mellitus Treated With Stable Triple Oral Therapy
Condition: Type II Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy of pioglitazone 30 mg on glycemic
      control when used in participants with inadequately controlled type 2 diabetes mellitus
      treated with stable combinations of metformin and sulfonylurea.
    

Detailed description: 
      The drug being tested in this study is called pioglitazone. Pioglitazone is being tested to
      treat glycemic control in adults with inadequately controlled type 2 diabetes mellitus. This
      study will look at glycemic control in people who take triple oral therapy of metformin,
      sulfonylurea, and pioglitazone 15 mg.

      The study will enroll approximately 114 patients. All participants will be asked to take one
      pioglitazone tablet at the same time each day throughout the study as well as continuing
      their previous dose of metformin and sulfonylurea.

      This multi-center trial will be conducted in Korea. The overall time to participate in this
      study is up to 25 weeks. Participants will make 4 visits to the hospital or endocrinologist's
      office, and will be contacted by telephone 7 days after last dose of study drug for a
      follow-up assessment.
    

Intervention name(s): Pioglitazone; Metformin; Sulfonylurea
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pioglitazone tablets; Metformin as prescribed in clinical practice; Sulfonylurea as prescribed in clinical practice
Other intervention name(s): ACTOS
Intervention MeSH terms: Metformin; Pioglitazone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug therapy
Usefulness of Myocardial Deformation Imaging for Trastuzumab-induced Cardiotoxicity
Condition: Left Ventricular Function Systolic Dysfunction; Cardiotoxicity
MeSH terms: Cardiotoxicity
Study type: Observational

Summary: 
      Trastuzumab prolongs survival in patients with human epidermal growth factor receptor type
      2-positive breast cancer. Sequential left ventricular (LV) ejection fraction (EF) assessment
      has been mandated to detect myocardial dysfunction because of the risk of heart failure with
      this treatment. Myocardial deformation imaging is a sensitive means of detecting LV
      dysfunction, but this technique has not been evaluated in patients treated with trastuzumab.
      The aim of this study was to investigate whether changes in tissue deformation, assessed by
      myocardial strain and strain rate (SR), are able to identify LV dysfunction earlier than
      conventional echocardiographic measures in patients treated with trastuzumab.
    

Detailed description: 
      The investigators will prospectively evaluate whether changes in tissue deformation, assessed
      by myocardial strain and strain rate (SR) and identify possibility of early detection of LV
      dysfunction in patients treated with trastuzumab.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The investigators evaluated serial echocardiograms (baseline, 3, 6, 9, and 12 months)from
        120 consecutive female patients receiving trastuzumab as part of their treatment for either
        early or advanced breast cancer.
      
Biospecimen description: 
      genetic susceptibility for HER2(+)cardiotoxicity
    
Keywords: myocardial deformation imaging; Trastuzumab
Evaluation of the Efficacy and Safety of AVANZ® Phleum Pratense in Grass Pollen-induced Allergic Rhinitis During Controlled Exposure in an Environmental Challenge Chamber
Condition: Grass Pollen Induced Allergic Rhinoconjunctivitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2

Summary: 
      The clinical trial will investigate the efficacy of Avanz Phleum pratense in the treatment of
      rhinitis in an environmental challenge chamber.
    


Intervention name(s): AVANZ Phleum pratense 15,000 SQ+; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Allergic rhinoconjunctivitis; Allergic rhinitis; Allergy; Grass pollen
A Safety Study of Live Attenuated Varicella Vaccines in Healthy Adults, Adolescents and Children
Condition: Varicella
MeSH terms: Chickenpox; Herpes Zoster
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of a live attenuated varicella vaccine in
      healthy adults, adolescents, and children.
    

Detailed description: 
      This study is a randomized, blind, single-center, controlled phase I clinical trial. The
      purpose of this study is to evaluate the safety of a live attenuated varicella vaccine
      manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. The positive control is a
      commercialized live attenuated varicella vaccine manufactured by Shanghai Institute of
      Biological Products Co., Ltd. (SIBP), and the negative control is diluent of lyophilized
      vaccine manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd. All participants are
      healthy, and will be randomly assigned into experimental group, positive control group, or
      negative control group in the ratio 1:1:1.
    

Intervention name(s): Investigational live attenuated varicella vaccine; control live attenuated varicella vaccine; diluent of lyophilized vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.; The control vaccine was manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP); The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: live attenuated varicella vaccine; safety; adult; adolescent; child
Prophylactic Antipyretic Treatment in Children Receiving Pneumococcal Conjugate and Standard Infant Vaccines
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to assess if the rate of febrile reactions following the
      co-administration of pneumococcal conjugate vaccines with standard infant vaccines is lowered
      when paracetamol is given prophylactically.
    

Detailed description: 
      2 groups (200 per group); control group receives no prophylactic antipyretic treatment.
    

Intervention name(s): 10 valent pneumococcal conjugate vaccine; Infanrix Hexa; Rotarix; Paracetamol
Intervention type(s): Biological; Biological; Biological; Drug
Other intervention name(s): Rotarix; Infanrix Hexa; 10 valent pneumococcal conjugate vaccine
Intervention MeSH terms: Acetaminophen; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pneumococcal Disease
Study of SyntheCelTM Dura Replacement to Other Dura Replacements
Condition: Cranial Dura Repair
Study type: Interventional

Summary: 
      Primary Objective: To demonstrate that the SyntheCelTM Dura Replacement performs similarly to
      or is substantially equivalent to other dura replacements for the repair of the cranial dura
      in patients undergoing surgical repair of the cranial dura.
    


Intervention name(s): SyntheCel; Other FDA cleared dura replacements
Intervention type(s): Device; Device
Intervention description(s): Patients will be clinically followed post-surgery until hospital discharge or within ten (10) days of the procedure and at one (1) month, three (3) months and six (6) months. The data up to and including the 6 month follow-up visit will be used in demonstrating the performance of SyntheCelTM Dura Replacement.; Patients will be clinically followed post-surgery until hospital discharge or within ten (10) days of the procedure and at one (1) month, three (3) months and six (6) months. The data up to and including the 6 month follow-up visit will be used in demonstrating the performance of SyntheCelTM Dura Replacement.
Other intervention name(s): Duraform Dural Graft Implant; Duragen II Dural Regeneration Matrix; Duragen Dural Graft Matrix; Durepair Dura regeneration Matrix
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: dura repair following cranial surgery