bioihbjkbjnl/mcl2 huggingface dataset:
Anti-CGRP for Inflamation and Pain Modulation in Small Fiber Neuropathy/Fibromyalgia
Condition: Trigeminal Neuralgia; Glossopharyngeal Neuralgia
MeSH terms: Fibromyalgia; Trigeminal Neuralgia; Neuralgia; Small Fiber Neuropathy; Glossopharyngeal Nerve Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators will treat patients (targeting enrollment of n=20) who suffer from
      trigeminal or glossopharyngeal nerve pain in the context of painful small fiber neuropathy.
      The primary pain-related objective is reduction of pain and reduced use of rescue and other
      anti-pain medications. Another goal is to monitor and confirm the safety profile established
      in the migraine population, during previous Phase 3 trials.
    


Intervention name(s): Galcanezumab
Intervention type(s): Drug
Intervention description(s): Injection of study drug at 3 timepoints (day 30, day 60, day 90)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Rifamycin SV-MMX® Tablets Versus Ciprofloxacin Capsules in Acute Traveller's Diarrhoea
Condition: Traveler's Diarrhea
MeSH terms: Dysentery; Diarrhea
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to prove the non-inferiority of Rifamycin SV-MMX® versus
      Ciprofloxacin for the treatment of adults with traveller's diarrhoea.
    


Intervention name(s): Rifamycin SV-MMX®; Ciprofloxacin
Intervention type(s): Drug; Drug
Intervention description(s): 2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d.; 1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d.
Intervention MeSH terms: Ciprofloxacin; Rifamycins; Rifamycin SV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Compare Pharmacokinetics and Pharmacodynamics of GP-40081 to NovoMix® 30 Penfill® in Healthy Subjects
Condition: Clamp Study
Study type: Interventional

Summary: 
      Pharmacokinetics and pharmacodynamics study of 2 formulations of biphasic insulin aspart 30
      (GP-40081 GEROPHARM vers. NovoMix® 30 Penfill® Novo Nordisk)
    

Detailed description: 
      A randomized double blinded two-way crossover single-dose pharmacokinetics and
      pharmacodynamics study of GP-40081 (LLC "GEROPHARM", Russia) versus NovoMix® 30 Penfill®
      (Novo Nordisk) in normal healthy subjects using the euglycemic clamp technique
    

Intervention name(s): GP-40081; NovoMix® 30 Penfill®
Intervention type(s): Drug; Drug
Intervention description(s): biphasic insulin aspart 30 in doses 0.4 IU/kg; biphasic insulin aspart 30 in doses 0.4 IU/kg
Other intervention name(s): biphasic insulin aspart 30; biphasic insulin aspart 30
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70; Insulin, Isophane
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: two-way crossover
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Pharmacokinetics; Pharmacodynamics; Biphasic Insulin Aspart
Chronic Mycoprotein Consumption and Nucleotide Content in Metabolic Health
Condition: Healthy
Study type: Interventional

Summary: 
      Compare chronic (one week) of a 'normal' meat diet with one week of mycoprotein consumption,
      with or without a reduced nucleotide content, on markers of metabolic health, such as uric
      acid concentrations, blood glucose control and blood lipid profiles.
    


Intervention name(s): Animal protein based diet; Low-nucleotide mycoprotein based diet; High-nucleotide mycoprotein based diet
Intervention type(s): Other; Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Spironolactone After Liver Transplant
Condition: Transplant, Liver
Study type: Interventional
Phase: Phase 4

Summary: 
      To study spironolactone to prevent calcineurin inhibitor (CNI) kidney injury.
    

Detailed description: 
      The aim of this study is to determine if spironolactone decreases nephrotoxicity from
      calcineurin inhibitors in liver transplant recipients and to determine the best study of
      renal function in liver transplant recipients.
    

Intervention name(s): Spironolactone
Intervention type(s): Drug
Intervention description(s): spironolactone 25 mg up to 50 mg
Intervention MeSH terms: Spironolactone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation
Condition: Disorder Related to Cardiac Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      This study investigated whether initiation of everolimus together with reduction of
      calcineurin inhibitors (CNI) in maintenance heart or lung transplant patients with renal
      impairment would improve renal function.
    


Intervention name(s): Everolimus; Mycophenolic acid (MPA)/azathioprine (AZA); Calcineurin inhibitors (CNI); Steroids
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 0.75-1.5 mg twice daily. At the week 1 visit and thereafter, the dose was adjusted to target blood concentration in the range 3-8 ng/mL.; In the standard CNI arm, all immunosuppressants including (MPA) and azathioprine (AZA) continued unchanged as per local practice.; Calcineurin inhibitors include cyclosporine, pimecrolimus, and tacrolimus.; Steroid treatment was according to local practice. If steroids were given, the baseline dose of prednisone or equivalent was to be kept unchanged for all treatment groups for the total study duration, unless a medical condition dictated a change.
Other intervention name(s): Certican; Neoral®/Prograf®
Intervention MeSH terms: Mycophenolic Acid; Everolimus; Azathioprine; Calcineurin Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: thoracic transplant recipients; everolimus; immunosuppressants
Study of CRx-401 on Glucose Levels in Subjects With Type II Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial will assess the efficacy of CRx-401 in lowering FPG levels in patients taking
      metformin to treat their diabetes. In addition, this initial trial will evaluate insulin
      resistance (HOMA-IR index), HgbA1c levels, glycated protein, LDL, HDL, triglycerides, and
      total cholesterol, as well as the safety of CRx-401.
    


Intervention name(s): bezafibrate + diflunisal; bezafibrate + placebo
Intervention type(s): Drug; Drug
Intervention description(s): bezafibrate + diflunisal; bezafibrate + placebo
Intervention MeSH terms: Diflunisal; Bezafibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Diabetes; CRx-401; Bezafibrate; Diflunisal; Metformin; plasma glucose
Influence of Foot Types on Collegiate Athletes
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of the study is to assess whether high or low arch foot types influence the
      overall performance of the athlete.
    

Detailed description: 
      After meeting the eligibility criteria for the study, university athletes have their general
      athletic condition variables evaluated in the laboratory and in the field. Subsequently,
      athletes with high and low arches perform 12-week foot muscle strengthening exercises to
      re-evaluate the variables in both athletes with high and low arch types who performed the
      strengthening exercises, as well as those with neutral arch who did not perform the
      exercises.
    

Intervention name(s): foot exercise
Intervention type(s): Other
Intervention description(s): These are foot and ankle muscle strengthening exercises described and evaluated by the literature
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: After initial measurements of dependent variables (electromyographic activity amplitude of core muscles, static stability, dynamic stability, ergospirometry, countermovement jump, and 40m sprint test), athletes are divided into two groups: 1) Case group, which is further classified into (a) athletes with high arched feet and (b) athletes with flat feet, and 2) Control group, consisting of athletes with neutral feet. The case group performs intrinsic and extrinsic foot muscle strengthening exercises for 12 weeks, while the control group does not engage in these exercises. Following intervention, both case and control groups are re-evaluated in dependent variables to conduct pre-post intervention variable comparisons.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: low foot; high foot; performance; core
MAD Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Intravenous Zidebactam in Healthy Adults
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to evaluate the safety and tolerability of multiple escalating doses of intravenous
      (IV) Zidebactam in healthy adult human subjects.
    

Detailed description: 
      A double-blind, placebo-controlled study where healthy adult subjects will be randomly
      assigned to receive either of the investigational products (Zidebactam or placebo) in 2
      multiple ascending dose (MAD) cohorts.

      Primary Objective: to evaluate the safety and tolerability of multiple escalating doses of
      intravenous (IV) zidebactam in healthy adult human subjects.

      Secondary Objective: to evaluate the pharmacokinetics (PK) of multiple escalating doses of IV
      zidebactam in healthy adult human subjects.
    

Intervention name(s): 3 g or 6 g Zidebactam; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IV for over a duration of 60 minutes; IV matching the Investigational drug
Other intervention name(s): WCK 5107
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Effects of Oral Motor Therapy in Children With Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      : CP is a neurodevelopmental condition. A set of irreversible impairments of movement and
      posture development, resulting in activity limitation. Acquired CP can be the outcome of a
      variety of issues that arise after the first 28 days of a baby's existence. A CP diagnosis
      can now be made as early as 16 weeks. speech-language pathologists (SLPs) began collaborating
      with OTs and PTs for Infants and toddlers who also struggle with speech impediments, feeding
      and swallowing disorder. Oral motor exercises (OMEs), also known as "mouth exercises,"
      "non-speech oral motor training," and "oral motor treatment" were designed for their
      treatment. The objective of this study was to assess the effects of oral motor exercises in
      children with cerebral palsy having feeding and swallowing difficulties.
    

Detailed description: 
      Over 17 million people throughout the world are living with cerebral palsy (CP), making it
      the most common physical disability among children. CP is a neurodevelopmental condition[1].
      Cerebral palsy is a fitting classification of the condition and its associated deficits
      because the word cerebral means "pertaining to the brain" and palsy means "loss of muscle
      control." A set of irreversible impairments of movement and posture development, resulting in
      activity limitation, that are linked to non-progressive disruptions that occurred in the
      developing foetus or infant brain, was chosen as the official definition of CP in 2005 by the
      International Consensus [2]. It's important to keep in mind that the phrase "cerebral palsy"
      refers to a spectrum of conditions, each of which has its own unique appearance, set of
      symptoms, and prevalence rate within the general population. In addition to the
      musculoskeletal and neurological symptoms of CP, epilepsy and other sensory and cognitive
      impairments are also common
    

Intervention name(s): Oral Motor Therapy
Intervention type(s): Other
Intervention description(s): In Traditional therapy we will give cognitive and articulation therapy to the patients.
Other intervention name(s): Traditional Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Oral Motor Therapy; Cerebral palsy; Drooling scale; Feeding and Swallowing
Early Gastric Decompression During Advanced Cardiopulmonary Resuscitation (EGD_ACLS)
Condition: Out-of-Hospital Cardiac Arrest
MeSH terms: Out-of-Hospital Cardiac Arrest
Study type: Interventional

Summary: 
      This study aimed to identify the effect of early gastric decompression on the improvement of
      circulation in arrest patients during cardiopulmonary resuscitation at the clinical setting
      of emergency department.
    

Detailed description: 
      Subjects and setting : adult sudden cardiac arrest patients in out of hospital, and
      transported to emergency department for advanced resuscitation treatment Interventions: first
      step, establish the advanced airway, after then insertion the naso (or oro)-gastric tube
      during CPR Data collection: live observation and review the automatically recoding data
      Missing or failed data should be collected and descriped Study period and sample size:
      numbers of participants necessary to identify the effect of interventions; 12 months or
      lesser were anticipated Analysis: All collected data can be analysed by Statistical programs
    

Intervention name(s): Gastric decompression
Intervention type(s): Procedure
Intervention description(s): Insertion the Naso(Oro)-gastric tube for early gastric decompression during CPR
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cardiopulmonary resuscitation; Gastric emptying
Immunogenicity and Safety of Combined Vaccine to Prevent Measles, Mumps, Rubella and Chickenpox Diseases
Condition: Mumps; Rubella; Measles; Varicella
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella; Mumps
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals
      live attenuated measles-mumps-rubella-varicella vaccine given to healthy children in their
      second year of life.
    


Intervention name(s): Measles, Mumps, Rubella and Chickenpox (live vaccine)
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Prophylaxis measles, mumps, rubella and chickenpox
A Clinical Study to Evaluate the Efficacy of an Anti-Aging Serum
Condition: Fine Lines; Wrinkle; Photoaging
Study type: Interventional

Summary: 
      This double-blind, randomized, controlled, single-center clinical trial was conducted to
      assess the efficacy and tolerance of an anti-aging serum to improve moderate overall
      photodamage and skin fatigue of aging skin after 7 days of twice-daily use when compared to
      the efficacy of a combination of anti-aging serum and an anti-aging facial moisturizer. A
      total of 26 female subjects, aged 34-60, completed study participation.
    

Detailed description: 
      This double-blind, randomized, controlled, single-center clinical trial was conducted to
      assess the efficacy and tolerance of an anti-aging serum (Cell 1) to improve moderate overall
      photodamage and skin fatigue of aging skin after 7 days of twice-daily use when compared to
      the efficacy of a combination of anti-aging serum and an anti-aging facial moisturizer (Cell
      2). Skin fatigue was characterized by dehydrated skin with a lack of firmness (visual) and a
      dull appearance on the global face.

      Efficacy and tolerability were assessed through clinical grading at baseline, day 3, and day
      7. Efficacy evaluation on fine lines and wrinkles in the crow's feet area; overall eye
      appearance on the periocular area; and smoothness (tactile), firmness (visual), radiance, and
      overall photodamage on the global face were performed 15 minutes post product application.
      Self-assessment questionnaires, Glossymeter measurements, and VISIA photography were
      completed at baseline, day 3, and day 7.

      A total of 26 subjects completed study participation, which included 12 subjects in Cell 1,
      and 14 subjects in Cell 2.
    

Intervention name(s): Anti-aging Serum; Facial Moisturizer; Cleansing Lotion; Sunscreen; Sunscreen
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Serum composed of a patent-pending botanical extract, bioavailable peptides, antioxidants, post-biotics, and short and long-term moisturizers; Anti-aging facial moisturizer to be used by study participants after serum; Facial cleansing lotion to be used by study participants; Sunscreen to be applied after application of serum in the morning. Participants were asked to reapply every 2 hours; Sunscreen to be applied after application of facial moisturizer in the morning. Participants were asked to reapply every 2 hours
Other intervention name(s): Revision Skincare® Cleansing Lotion; Aveeno Positively Mineral Sensitive Skin SPF 40+; Aveeno Positively Mineral Sensitive Skin SPF 40+
Intervention MeSH terms: Sunscreening Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, controlled, single-center
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: anti-aging; serum
The Effect of Traditional Chinese Treatment Combined Adjuvant Chemotherapy in IIIb and IIIc Gastric Cancer
Condition: Gastric Cancer Stage IIIB; Gastric Cancer Stage IIIC
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a randomized, open-label study done in 3 hospitals in China. Patients with stage IIIB
      and IIIC gastric cancer who undergo curative D2 gastrostomy will be randomly assigned after
      surgery to receive adjuvant chemotherapy with oxaliplatin and capecitabine, or adjuvant
      chemotherapy combined Traditional Chinese treatment. The primary outcome was disease-free
      survival and 3-year disease-free survival rate in the intention-to-treat population.
    

Detailed description: 
      The purpose of this study is to evaluate the Traditional Chinese Medicine combined adjuvant
      chemotherapy in the treatment of stage IIIb and IIIc gastric cancer through randomized
      controlled trial.

      Metastasis and recurrence is the primary cause in decreasing the survival time of gastric
      cancer patients who experienced radical operation. Among whom, patients with stage IIIB and
      IIIC are especially in high risk of metastasis and recurrence, result in a significant poor
      survival time than patients with earlier stages.

      Oxaliplatin with capecitabine is the standard adjuvant chemotherapy for curative D2
      gastrostomy gastric cancer, contribute the 3-year disease free survival rate of 74% in ITT,
      and 61% in stage IIIB sub-group. Meanwhile, Traditional Chinese Medicine (TCM) treatment has
      been used for thousands of years in Chinese clinical practices. In China, the clinical
      curative effect of TCM in the treatment of gastric cancer has been part of affirmation. Some
      reports with large samples of clinical research show that the TCM is effective and safety for
      gastric cancer.In order to evaluate efficacy on TCM combined adjuvant chemotherapy in IIIB
      and IIIC gastric cancer, we design this randomized, open-label study.
    

Intervention name(s): Oxaliplatin; Capecitabine; TCM; S-1; Docetaxel; 5-FU
Intervention type(s): Drug; Drug; Other; Drug; Drug; Drug
Intervention description(s): Oxaliplatin powder injection; Capecitabine tablet; TCM decoction orally taken twice a day for at least 3 months; S-1 capsule; Docetaxel injection; 5-FU injection
Intervention MeSH terms: Docetaxel; Capecitabine; Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effect of Magnesium Sulphate Infusion on Lung Mechanics and Oxygenation in COPD Patients Undergoing Total Laryngeal
Condition: Chronic Obstructive Pulmonary Diseases
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      Chronic Obstructive Pulmonary Disease [COPD] is a major cause of chronic morbidity and
      mortality worldwide. COPD is characterized by persistent progressive airflow limitation that
      adversely affects the ventilation/perfusion (V/Q) matching and mechanics of the respiratory
      muscles and leads to hypoventilation and reduced gas transfer. COPD was identified as a
      significant comorbidity associated with increased incidences of postoperative pulmonary
      complications and prolonged hospital stay. MgSO4 either intravenous or inhalational has been
      shown to promote bronchodilation and to improve lung function in asthmatic patients. MgSO4
      either intravenous or inhalational has been shown to promote bronchodilation and to improve
      lung function in asthmatic patients. Administration of MgSO4 in patients with stable COPD was
      associated with reduced lung hyperinflation and improvement of respiratory muscle strength.
      This randomized control trial is designed to assess the effect of intravenous MgSO4 infusion
      on oxygenation and pulmonary mechanics and incidence of postoperative pulmonary complications
      and length of hospital stay in patients with COPD undergoing cancer larynx surgery.
    


Intervention name(s): Magnesium Sulphate
Intervention type(s): Drug
Intervention description(s): intra-operative infusion of of 10% MgSO2 , stating by a laoding dose of 30be used, a loading dose of 30 mg/kg over 20 min followed by continuous infusion of 10 mg/kg/hr accomplish the total laryngectomy.
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intra-operative intravenous infusion of magnesium sulphate in patients with chronic obstructive pulmonary diseases undergoing total laryngectomy and assess the influence on arterial oxygenation and pulmonary Mechanics in
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: magnesium sulphate, chronic obstructive pulmonary diseases