bioihbjkbjnl/mcl2 huggingface dataset:
Targeting Metabolic Flexibility in Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis; Motor Neuron Disease
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      MetFlex is an investigator led, open-label, single-arm, Phase 2a trial to determine the
      safety and tolerability of trimetazidine for the treatment of amyotrophic lateral
      sclerosis/motor neuron disease (ALS/MND).
    

Detailed description: 
      The study will consist of a 4-week lead-in period to obtain a stable baseline measurement of
      clinical markers of disease and oxidative stress. After the lead-in phase, participants will
      receive trimetazidine for 12 weeks. Participants will visit the clinic at 6-week intervals,
      during which we will obtain a blood sample to measure the pharmacodynamic response. We will
      also collect information regarding the rate of disease progression (i.e. ALSFRS-R and SVC).
      At weeks 3 and 9 of treatment, participants will conduct a teleconference visit, during which
      we will collect data on ALSFRS-R. Adverse events will be collected and recorded throughout
      the entire trial duration. At the end of the on-treatment period, a close-out visit will
      occur after four weeks. The total study period per participant will be 20 weeks.
    

Intervention name(s): Trimetazidine Dihydrochloride
Intervention type(s): Drug
Intervention description(s): Oral tablet, twice-daily
Intervention MeSH terms: Trimetazidine
Intervention model: Single Group Assignment
Intervention model description: Open-label, single-arm study without placebo
Masking: None (Open Label)
Primary purpose: Treatment
A Single and Multiple Ascending Dose Study of ANX009 in Normal Healthy Volunteers (NHV)
Condition: Safety and Tolerability in Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmakokinetics and
      pharmacodynamics of single and repeated doses of ANX009
    

Detailed description: 
      In this first in human, phase 1, randomized, double-blind, placebo-controlled study, single
      and multiple ascending doses of ANX009 or placebo will be administered to 48 healthy
      subjects.

      Single Ascending Dose (SAD): Each SAD subject will participate for approximately 4 weeks (3
      nights in-clinic confinement).

      Multiple Ascending Dose: Each MAD subject will participate for approximately 6 weeks (17
      nights in-clinic confinement).

      All subjects will be contacted (in clinic visit or phone call) 6 months after study
      completion.
    

Intervention name(s): ANX009; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single or multiple ascending dose; Single or multiple ascending dose
Other intervention name(s): 009; matching placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Functional Food Application of Okara Protein Hydrolysate (OPH)- for Anti-exercise-fatigue
Condition: Healthy
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The aim of this study is to investigate the anti-exercise-fatigue effects of okara protein
      hydrolysate (OPH) in men
    

Detailed description: 
      Each subject must undergo a cardiopulmonary capacity test to assess the maximum oxygen uptake
      1 week before the intervention (day 1), and then eat the test food for 4 weeks (day 8 to day
      35). Before and after the intervention (the 8th and 35th day), posture measurement, diet
      questionnaire survey and endurance exercise ability test were carried out. The trial period
      was 35 days. The subjects will take blood samples before, during, after, and 30 minutes and
      60 minutes after the end of the two endurance exercise tests. During the whole period of
      participating in the program, blood will be collected 10 times, each with a blood volume of
      15 mL. Gas is collected during the period and within 1 hour after exercise. Gas is collected
      every 15 minutes and 1 minute at a time. Analyze his exercise time, oxygen intake and blood
      biochemical value.
    

Intervention name(s): Okara protein hydrolysate (OPH)
Intervention type(s): Dietary Supplement
Intervention description(s): Okara protein hydrolysate (OPH) was a pack of dried beige powder. It can be stored at room temperature, but it must be exposed to direct sunlight.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Lidocaine Gel During Transrectal Sonography
Condition: Gynecologic Diseases
MeSH terms: Genital Diseases, Female
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this clinical trial is to evaluate the use of topical lidocaine gel in reducing
      pain associated with transrectal ultrasonography (TRS) in gynecologic field.
    

Detailed description: 
      TRS is the common procedure to diagnose or exclude gynecologic disease in virgin women. This
      procedure can be associated with significant pain, both on insertion of the ultrasound probe
      as well as on manipulating the probe. The investigators evaluated a new technique for pain
      relief during TRS. In all, 80 consecutive subjects undergoing TRS at obstetric and
      gynecologic department were randomized to receive either lidocaine gel(Instillagel) or
      placebo(Aquagel) rectally prior to probe insertion. The pain encountered before, during, and
      after the procedure was graded by the patient on a 10-point visual analogue score. The
      gel-associated side effect was also evaluated by phone survey after 2 day of procedure. The
      aim of this clinical trial is to evaluate the use of topical lidocaine gel in reducing pain
      associated with transrectal gynecologic ultrasonography.
    

Intervention name(s): Lidocaine gel; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Instillagel (2% lidocaine) was administered rectally prior to probe insertion.; Placebo (Aquagel) was administered rectally prior to probe insertion.
Other intervention name(s): Instillagel; Aquagel
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Study to Verify the Effectiveness and Safety of Isothymol or Carvacrol Compound Against SARS-CoV-2 in COVID-19 Patients
Condition: COVID-19; COVID-19 Pneumonia; COVID-19 Respiratory Infection; COVID-19 Acute Respiratory Distress Syndrome; COVID-19 Lower Respiratory Infection
MeSH terms: Infections; Communicable Diseases; COVID-19; Respiratory Tract Infections; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      • Check the efficacy, safety and tolerability of the compound Modified isothymol against the
      SARS-CoV-2 agent in patients COVID-19.
    

Detailed description: 
      -  Evaluate the inhibition of the terminal glycosylation of the Enzyme Angiotensin II
           converter (ECE2).

        -  Check the inhibition of the main protease function (Mpro) of the SARS-CoV-2 agent by
           stable binding of the drug/protein to control viral replication.

        -  Check the oxidation reaction of the amine R-CH2-NH2 involved in the hyperactivation of
           macrophages (immune system innate), by interference of modified Isothymol.

        -  Evaluate the increase in tolerance to hypersensitivity of the immunoglobulins G (IgG)
           and immunoglobulins M (IgM) in patients COVID-19.

        -  Check the suppression of production and adhesion of superoxides in neutrophils
           (Immunostimulatory effect) through the regulation of cytokines and IL-6 (interleukins)
           for the inhibition of cytokine storm (Stage 2 and 3, infected patient).
    

Intervention name(s): Carvacrol; Control group
Intervention type(s): Drug; Other
Intervention description(s): Carvativir 6 mg/ml diluted for oral solution.; Placebo
Other intervention name(s): CARVATIVIR
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, multicenter study with blind evaluation of events, designed to compare the efficacy and safety of Isothymol modified with placebo in patients ≥18 years of age who meet the inclusion criteria.
Drug administration scheme: Randomized and parallel (modified isothymol and placebo).
Statistical design: Superiority. It will allow to detect difference between drug and placebo after parallel administration.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: SARS-CoV-2; Isothymol; Carvacrol; Antiviral; COVID-19; RNA; Cytokine storm
Transcutaneous Electrical Acupoint Stimulation(TEAS) for Hepatic and Renal Dysfunction After Pneumoperitoneum
Condition: Hepatic Dysfunction Transient; Renal Function Disorder
MeSH terms: Pneumoperitoneum
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effect of TEAS pretreatment and treatment on
      hepatic and renal dysfunction induced by pneumoperitoneum in patients undergoing laparoscopic
      surgeries.
    

Detailed description: 
      Patients were randomly assigned to three groups, control group and two intervention groups,
      receiving TEAS before and after general anesthesia induction respectively. TEAS was given
      through electrodes attached to acupoints. The time for TEAS was 30min. Venous blood samples
      were collected before and 20min after pneumoperitoneum. Hepatic and renal function index
      including AST, ALT, ALP, BUN, Cr were measured.
    

Intervention name(s): TEAS pretreatment; TEAS treatment
Intervention type(s): Other; Other
Intervention description(s): Electric stimulation was given through electrode attached to specific acupoints for 30mins before anesthesia induction; Transcutaneous Electrical Acupoint Stimulation was given to the patient at the same time of the start of anesthesia induction for 30mins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: hepatic dysfunction; renal dysfunction; pneumoperitoneum; Transcutaneous electric stimulation
A Drug-Drug Interaction Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Apremilast
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate how the pharmacokinetics of apremilast may be
      affected by a single intravenous dose of rifampin and multiple oral doses of rifampin.
    


Intervention name(s): Apremilast; Rifampin Oral Capsules; Rifampin IV Solution
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets for oral administration; Capsules for oral administration; Intravenous (IV) solution
Other intervention name(s): CC-10004; Otezla®; RIFADIN™; RIFADIN™
Intervention MeSH terms: Rifampin; Apremilast
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Apremilast; drug interaction; pharmacokinetics
Safety and Efficacy of Intrathecal Morphine in Children
Condition: Abdominal Cancer
Study type: Interventional
Phase: Phase 2

Summary: 
      Postoperative pain in pediatrics can usually be well controlled with a combination of
      analgesics including acetaminophen ( paracetamol) ,NSIADS, opioids , and local/regional
      anesthesia.The use of epidural and subarachnoid morphine for analgesia in adults has grown
      almost as quickly as Morton's discovery of anesthesia in 1846. The application of these
      techniques to the pediatric patients has evolved much more slowly,although significant
      progress is being made by many investigators.
    

Detailed description: 
      Advantage of intrathecal morphine as that extremely small doses of opioids are required when
      administrated intrathecally because they have direct access to spinal cord opioid receptors.
      Drug administered epidurally or caudally are required in much higher doses because they must
      first diffuse into the CSF before they reach spinal opioid receptors. As a result, the
      duration of action of intrathecal morphine is greater than that of single shot peridural
      techniques.

      To investigate the safety and efficacy of intrathecal morphine in post operative pain relief
      in pediatric patients undergoing major abdominal cancer surgeries using different doses of
      intrathecal morphine (2 μg/kg , 5 μg/kg ,10μg/kg).
    

Intervention name(s): intrathecal morphine
Intervention type(s): Procedure
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: intratehcal injection of drug( morphine).
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Stimulation of Parieto-hippocampal Connectivity in Patients With Major Depressive Disorder
Condition: Depression; Depressive Disorder; Depressive Episode; Depressive Disorder, Major
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      This study aims to investigate the effects of individualized repetitive transcranial magnetic
      stimulation (rTMS) of parieto-hippocampal functional connectivity in patients with major
      depressive disorder (MDD). Specifically, patients will be randomized to one of three groups
      and will receive 15 days of rTMS over three weeks. Each day they will receive one active
      session of rTMS over the dorsolateral parietal cortex (DLPFC) and depending on group
      assignment another session either A) active rTMS over DLPFC, B) active rTMS over left and
      right lateral parietal cortex (LPC), or C) sham rTMS over DLPFC or LPC. Stimulation targets
      in the LPC will be individualized for each patient based on their resting-state functional
      connectivity between the hippocampus and LPC. Clinical, neuropsychological and fMRI data will
      be acquired before and after the treatment course.
    


Intervention name(s): active rTMS over DLPFC; Add-on active rTMS over DLPFC; Add-on active rTMS over LPC; Add-on sham rTMS
Intervention type(s): Device; Device; Device; Device
Intervention description(s): 15 sessions of active rTMS over DLPFC; 15 additional sessions of active rTMS over DLPFC; 15 additional sessions of active rTMS over LPC; 15 additional sessions of sham rTMS over DLPFC or LPC
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Repetitive Transcranial Magnetic Stimulation; Theta Burst Stimulation; rTMS; TBS; resting-state fMRI; functional connectivity
Glycaemic and Insulinaemic Responses After Consumption of FOS.
Condition: Glycaemia
Study type: Interventional

Summary: 
      The study aims to evaluate the glycaemic and insulinaemic response of short-chain
      fructo-oligosaccharides (scFOS) used to replace sugars (e.g. dextrose) in foods.
    


Intervention name(s): Sugar; FOS
Intervention type(s): Other; Other
Intervention description(s): 100g of sponge cakes made with 24g of dextrose.; 100g of sponge cakes made with 19.4g of dextrose and 9.1g of FOS.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Fructo-oligosaccharides; Sugar-reduced foods; Postprandial glucose response
A Trial Evaluating a 7-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants.
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 4

Summary: 
      Subjects will be randomly assigned to 1 of 2 groups to receive the following vaccines: Group
      1: 7-valent pneumococcal conjugate vaccine (7vPnC) and diphtheria, tetanus, and accelular
      pertussis vaccine (DTaP), Group 2: DTaP alone. Group 2 subjects will also receive catch-up
      doses of 7vPnC. The study vaccines will be open-label. The main purpose of the study is to
      demonstrate that the immune responses as measured by serum antibody responses to diphtheria
      toxin, tetanus toxin, pertussis toxin (PT) and filamentous haemagglutinin (FHA) induced by
      DTaP given concomitantly with 7vPnC are comparable to the immune responses induced by DTaP
      given alone. In addition, the study aims to evaluate the side effects (safety profile) after
      vaccination of 7vPnC when given with DTaP in healthy Japanese infants.
    


Intervention name(s): 7-pneumococcal conjugate vaccine (7vPnC); diphtheria, tetanus, and acellular pertussis vaccine (DTaP); DTaP
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL per dose, 4 doses; 0.5 mL per dose, 4 doses; 0.5 mL per dose, 4 doses
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vaccine; pneumococcal conjugate
Association of AGTR1 and ACACB Gene Polymorphism and Diabetic Nephropathy in Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Kidney Diseases; Diabetic Nephropathies; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      India is the "Diabetes Capital of the World" with 41 million Indians having diabetes, with
      every fifth diabetic in the world being an Indian and type 2 Diabetes Mellitus (T2DM)
      constitutes the major chunk of diabetes. One of the most severe complications of diabetes is
      the development of diabetic nephropathy. Diabetic nephropathy (DN) is the leading cause of
      end-stage renal disease (ESRD) worldwide. There are many identifiable risk factors of
      diabetic nephropathy like hyperglycemia, hyperlipidemia, hypertension, and proteinuria, the
      genetic factor is the main among all. Long-term observational studies show that nearly 30-35%
      of type 2 diabetic patients develop nephropathy, irrespective of glycemic control. The
      regional variation in diabetes prevalence and in the proclivity for diabetes induced renal
      disease; along with reports of familial clustering of nephropathy suggest a possible genetic
      basis. The renin-angiotensin system (RAS) has been strongly implicated in the pathogenesis of
      progressive renal diseases. In addition, the blockage of angiotensin II with either ACE
      inhibitor or an angiotensin type-I receptor antagonist has been found to prevent or delay the
      progression of renal injury associated with diabetes 5 and now these drugs are first-choice
      drugs for the treatment of diabetic subjects with hypertension. The genes encoding the
      renin-angiotensin system (RAS), such as angiotensin-converting enzyme (ACE), angiotensinogen
      (AGT) and angiotensin II receptor type 1 (AGTR1), have been reported to be the most probable
      candidate genes for diabetic nephropathy. As there is no data available for AGTR1
      polymorphism and DN in the north Indian T2DM, its out attempt to fill the scientific gap.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Study Population for Group 1 and Group-2 (Subjects with diabetic nephropathy and without
        nephropathy respectively)will be recruited from the diabetic Out Patient and in patient
        services of Postgraduate Institute of Medical Education & Research and Nehru hospital,
        Chandigarh. Only North Indian Ethnic subjects will be recruited.
      
Biospecimen description: 
      4 ml of whole blood sample.
    
Keywords: Type 2 Diabetes Mellitus; Diabetic Nephropathy; Angiotensin II type 1 receptor gene polymorphism; Acetyl coA carboxylase beta gene polymorphism.
Mechanisms of Walking Recovery After Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      Subjects with stroke will have behavioral testing and brain imaging before and after a 4-week
      control period and a 4-week exercise intervention.
    

Detailed description: 
      Subjects with stroke will have behavioral testing and brain imaging before and after a 4-week
      control period and a 4-week exercise intervention using high-intensity interval training.
    

Intervention name(s): No intervention; High-intensity interval training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): No intervention; High-intensity walking exercise using bursts of concentrated effort alternated with recovery periods
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Study To Assess The Efficacy And Safety Of Pf-06651600 In Subjects With Rheumatoid Arthritis With An Inadequate Response To Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an 8 week study to assess the efficacy and safety profile of PF-06651600 in
      seropositive subjects with rheumatoid arthritis with an inadequate response to methotrexate
      (up to approximately 50% of subjects may also have had an inadequate response to 1 anti-TNF
      biologic).
    


Intervention name(s): Placebo; PF-06651600
Intervention type(s): Drug; Drug
Intervention description(s): 200mg pill every day (QD) for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of the Cosmetic Effects of Bakuchiol and Retinol
Condition: Wrinkle; Photoaging
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Subjects will be assigned to a retinoid cream or bakuchiol to compare the cosmetic effects.
      This will take place over a 12 week period.
    

Detailed description: 
      Bakuchiol is a phytochemical that has demonstrated cutaneous antiageing effects when applied
      topically. Early studies have suggested that bakuchiol is a functional analogue of topical
      retinoids, as both compounds have been shown to induce similar gene expression in the skin
      and lead to improvement of cutaneous photodamage. No in vivo studies have compared the two
      compounds for efficacy and side-effects.

      The aim of this study is to compare the cosmetic effects of Bakuchiol to Retinol over a
      12-week period.
    

Intervention name(s): Bakuchiol; Retinol
Intervention type(s): Drug; Drug
Intervention description(s): This group will receive bakuchiol; This group will receive retinol
Other intervention name(s): Bakuchiol 0.5%; Retinol %
Intervention MeSH terms: Vitamin A; Retinol palmitate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind randomized study comparing the effect of bakuchiol and retinoid
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment