bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy of Metformin as Preventive Treatment in Paclitaxel Induced Peripheral Neuropathy in Breast Cancer Patients
Condition: Peripheral Neuropathy; Breast Cancer
MeSH terms: Breast Neoplasms; Peripheral Nervous System Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      At present, there are no FDA-approved treatments for chemotherapy-induced neuropathy.
      Discrete neuro anti-inflammatory effects of metformin support its repurposing as a
      neuroprotective agent in patients with neurodegenerative diseases. Therefore, this study aims
      to evaluate the effect of metformin on the amelioration of paclitaxel induced neuropathy in
      cancer patients.
    


Intervention name(s): Metformin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): cidophage 850 gm twice daily; placebo twice daily for treatment period
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Thorough Corrected QT Interval (QTc) Study To Evaluate Possible Effects of Prucalopride on ECG Parameters
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2-arm, parallel-group active- and placebo-controlled, double-blind randomised
      study, stratified by gender and with a hybrid crossover group design, to compare treatment
      with prucalopride 2 mg/day (intended therapeutic dose) and prucalopride 10 mg/day
      (supratherapeutic dose) with placebo. A single oral dose of 400 mg moxifloxacin is included
      as a positive control in terms of the effect on cardiac repolarisation.

      Study hypothesis:

      Treatment with therapeutic (2 mg) or supratherapeutic (10 mg) doses of prucalopride in
      healthy male and female volunteers will not increase QTc interval compared to placebo.
    

Detailed description: 
      A total number of 120 healthy subjects (with an approximate 1:1 female:male ratio) are
      planned to be randomised.

      Day 1: a baseline ECG profile. Day 1: Group 1 will receive prucalopride, Group 2a will
      receive moxifloxacin, and Group 2b will receive placebo.

      On Day 5 (steady-state level is reached), a full ECG assessment day will be performed,
      enabling the comparison of prucalopride 2 mg with placebo.

      Subsequently, the number of tablets will be escalated in all groups (blinded) with 1 tablet a
      day up to 5 tablets.

      On Day 13 (steady state for the supratherapeutic dose level of 10 mg of prucalopride) another
      ECG assessment day will be performed, enabling a comparison of prucalopride 10 mg with
      placebo.

      Group 2b will receive a single dose of moxifloxacin on Day 15. All subjects will be
      discharged on Day 16. Subjects will remain in the CRU throughout the treatment period.

      All subjects will return for a follow-up visit on Day 30 (± 1 week) (approximately 14 days
      after the last dose).
    

Intervention name(s): prucalopride; moxifloxacin; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 2-10 mg prucalopride; 400 mg moxifloxacin (Group 2a); placebo (Group 2b)
Other intervention name(s): Resolor; Avelox
Intervention MeSH terms: Moxifloxacin; Prucalopride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Prucalopride; safety study
Effects of Consuming Artificial Sweeteners and Sugar on Cerebral and Physiological Responses
Condition: Normal Subjects
Study type: Interventional

Summary: 
      This study aims at investigating the acute influence of artificially sweetened beverages
      consumption (as compared with sugar-sweetened beverages and water consumption) on brain
      responses to the viewing of food images, on physiological responses (gut-derived hormones and
      lipid metabolites) and on the food intake behavior.
    

Detailed description: 
      This study is made on a randomized controlled crossover design including three conditions
      (water, sugar, artificial sweeteners). Measurements will be performed in fasting and fed
      conditions. The test-meal will comprise either an artificially or sugar-sweetened beverage or
      water (control). The spatio-temporal brain dynamics to the viewing of food pictures will be
      assessed by means of electroencephalography (EEG) recordings and electrical neuroimaging
      analyses. Venous blood and urine will be collected. Blood pressure, cardiac frequency and
      bio-impedance measurements will be performed. Food intake behavior will be assessed by means
      of questionnaires and a free-choice buffet. Each tested condition (water, sugar, artificial
      sweeteners) will be preceded by a run-in period during which the participants' diet will be
      controlled (2-day isoenergetic diet).
    

Intervention name(s): ingestion of a test meal with sweetener; ingestion of a test meal with sweetener; ingestion of a test meal with water
Intervention type(s): Other; Other; Other
Intervention description(s): participants will ingest a test meal containing 55% carbohydrate, 30% fat and 15% protein with artificially sweetened drinks; participants will ingest a test meal containing 55% carbohydrate, 30% fat and 15% protein with sugary drinks drinks; participants will ingest a test meal containing 55% carbohydrate, 30% fat and 15% protein with waters
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: sweeteners; sugar; EEG; food viewing; food intake
Intragastric and Peritoneal Microdialysis in Infants With Necrotizing Enterocolitis (NEC)
Condition: Necrotizing Enterocolitis
MeSH terms: Enterocolitis; Enterocolitis, Necrotizing
Study type: Observational

Summary: 
      NEC is a serious inflammatory bowel disease, which almost only strikes infants with low birth
      weight and low gestational age. The morbidity and mortality rates are high, and early
      diagnosis and treatment is mandatory. The primary aim of the present study is to investigate
      the clinical use of intragastric microdialysis and whether it is able to select patients, who
      may benefit from either medical or surgical therapy. The aim of intraperitoneal microdialysis
      is to evaluate whether changes in intraperitoneal microdialysis reflect the clinical outcome
      after laparotomy.
    

Detailed description: 
      Neonates who are hospitalized because of suspicion of NEC are subjected to intragastric
      microdialysis during the observation period. The catheter is placed in the stomach via the
      naso-oesophageal route. If surgery is necessary a microdialysis catheter is placed in the
      peritoneal cavity prior to wound closure. Samples are collected every 4-hour. Samples will be
      analyzed continuously but the results will not be included in the clinical evaluation of the
      patient.

      A total of 20 patients will be included in this pilot study. The results of the intragastric
      and peritoneal microdialysis will be compared with the clinical course, s-lactate,
      radiological and pathological findings in each patient.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Premature children with NEC
      
Keywords: Necrotizing Enterocolitis; Intragastric microdialysis; Peritoneal microdialysis; Infants
Effect of P-glycoprotein Inhibition on Lenalidomide Pharmacokinetics in Healthy Males
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To find out if the blood level of lenalidomide can be changed when a drug that prevents
      p-glycoprotein (a protein naturally present in the body that helps carry substances across
      cell membranes that is found in many parts of the body like the intestines, liver, and
      kidneys) from working (called a P-gp inhibitor) when taken together with lenalidomide. The
      study is also trying to find out if blood level of temsirolimus can be changed when a subject
      takes lenalidomide together with temsirolimus.
    

Detailed description: 
      This will be a single-center, open label, 2-part study. Part 1 will be a two-period,
      fixed-sequence crossover study with lenalidomide alone in Period 1, followed by lenalidomide
      in combination with quinidine in Period 2. Part 2 will be a fixed-sequence, three-period,
      crossover study with lenalidomide alone in Period 1, temsirolimus (via direct intravenous
      infusion) in Period 2, and lenalidomide in combination with temsirolimus (via direct
      intravenous infusion) in Period 3. Diphenhydramine (given via intravenous injection) will be
      administered shortly before temsirolimus in order to decrease the chances of an allergic
      reaction to temsirolimus. Part 1 and Part 2 will be conducted at the same time. Subjects can
      only participate in either Part 1 or Part 2.
    

Intervention name(s): Lenalidomide; Quinidine; Temsirolimus; Diphenhydramine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 25 mg Lenalidomide capsule will be administered orally once in the first period, and once with Quinidine in the second period; 300 mg of Quinidine will be administered orally every 12 hours for 1 day followed by 600 mg of Quinidine administered orally every 12 hours for the next 4 consecutive days; 25 mg/mL injection of Temsirolimus will be given directly into the vein over 30 minutes once in the second period and once with Lenalidomide in the third period.; Just before Temsirolimus is given, 25 mg of Diphenhydramine (Benadryl) will be given directly into the vein to decrease chances of an allergic reaction to Temsirolimus.
Other intervention name(s): Benadryl
Intervention MeSH terms: Diphenhydramine; Promethazine; Sirolimus; Quinidine; Lenalidomide; Temsirolimus; MTOR Inhibitors
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Lenalidomide,; Revlimid,; pharmacokinetics,; healthy male subjects
A Phase I Safety and Immunogenicity Trial of UBI SynVac (HIV-1 MN Octameric V3 Peptide Vaccine)
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the safety, immunogenicity, and optimal dose of rgp120/HIV-1MN octameric V3
      peptide vaccine (SynVac) in healthy volunteers.

      It is likely that the ultimate control of AIDS will depend on the development of safe and
      effective vaccines against HIV-1. SynVac is a synthetic candidate vaccine based on eight
      V3-derived peptides attached to a heptalysyl core to form radial octamers. In animal studies,
      the vaccine appears safe and demonstrates the capability for producing immune responses.
    

Detailed description: 
      It is likely that the ultimate control of AIDS will depend on the development of safe and
      effective vaccines against HIV-1. SynVac is a synthetic candidate vaccine based on eight
      V3-derived peptides attached to a heptalysyl core to form radial octamers. In animal studies,
      the vaccine appears safe and demonstrates the capability for producing immune responses.

      Twelve volunteers are entered at one of three dose levels of SynVac. At each dose level, 10
      volunteers receive vaccine and two receive placebo. At least eight volunteers at each dose
      level must be monitored for 1 week before subsequent volunteers are entered at the next
      higher level. Intramuscular injections are given on day 0, 28, and 168. Approximately 12
      clinic visits are required.
    

Intervention name(s): rgp120/HIV-1MN Monovalent Octameric V3 Peptide Vaccine
Intervention type(s): Biological
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; HIV-1; HIV Envelope Protein gp120; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine
Treatment of Temporomandibular Dysfunction With Hypertonic Dextrose Injection
Condition: Temporomandibular Joint Disorders
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Dysfunction of the jaw, associated with pain in the jaw or about the jaw in the face can be
      quite long lasting and debilitating. Dextrose injection with a small needle has been notably
      helpful in preliminary studies in reducing pain and improving jaw function. This randomized
      trial will compare dextrose injection with sterile water injection for temporomandibular(jaw)
      dysfunction, also known as TMD.
    

Detailed description: 
      Longitudinal studies of subjects with temporomandibular dysfunction show a general pattern of
      symptom diminishment, especially in the elderly. However studies out to 2-8 years show
      residual symptoms in many and nearly 25% with unabated symptoms. Dextrose injection has been
      utilized empirically for many years and a marked reduction in pain and luxation after
      intra-articular and pericapsular dextrose injection has been reported in a recent RCT.
      However, small study size and lack of a non injection control have prevented any definitive
      conclusions as the additional efficacy of including dextrose in the injectate. The mechanism
      of action of dextrose injection was originally thought to be via a brief stimulation of the
      inflammatory cascade with resultant production of growth factors. However, non-inflammatory
      dextrose effects on growth factor production have been demonstrated, and, more recently,
      dextrose has been found to treat neurogenic inflammation (pain from upregulation of the TRPV1
      receptor on peptidergic nerves). This has the theoretical benefit of reducing pain,
      regardless of the status and position of the intraarticular cartilage or degree of
      degenerative change of the TMD. The primary goal of this study is to evaluate the ability of
      dextrose injection versus saline injection to reduce pain and improve functional complaints
      referable to the temporomandibular joint.
    

Intervention name(s): Injection of 20% dextrose/ 0.2% lidocaine; Injection of 1 ml of 0.8 Sterile water /0.2% lidocaine
Intervention type(s): Other; Other
Intervention description(s): Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 20% dextrose and 0.2% lidocaine.; Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 0.8 sterile water and 0.2% lidocaine
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TMD; temporomandibular; dextrose; prolotherapy
Pharmacokinetics and Safety Between "DWJ1421" and "DWC201903" in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, open label, single dose, crossover study to compare the
      pharmacokinetics and safety between "DWJ1421" and "DWC201903" in healthy male volunteers.
    


Intervention name(s): DWJ1421; DWC201903
Intervention type(s): Drug; Drug
Intervention description(s): 1 tablet administered in fasting condition; 1 tablet administered in fasting condition
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Assessing The Long-Term Safety And To Explore The Long-Term Efficacy Of Zonisamide As Monotherapy In Newly Diagnosed Partial Seizures
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the long-term safety and tolerability and to explore
      the long-term efficacy of zonisamide as monotherapy treatment in subjects with newly
      diagnosed partial seizures.
    


Intervention name(s): Zonisamide; Carbamazepine
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will start on the same dose that was achieved at the end of study E2090-E044-310. Maximum daily dose allowable is 500 mg; the minimum daily dose allowable is 200 mg. During the study, subjects will be titrated up or down depending on seizure-free status or intolerability/adverse events, respectively. Should a dose outside of the maximum be required the subject will be with drawn and gradually down titrated by 100 mg per week.; Subjects will start on the same dose that was achieved at the end of study E2090-E044-310. Maximum daily dose allowable is 1200 mg; the minimum daily dose allowable is 400 mg. During the study, subjects will be titrated up or down depending on seizure-free status or intolerability/adverse events respectively. Should a dose outside of the maximum be required the subject will be with drawn and gradually down titrated by 200 mg per week.
Other intervention name(s): Zonegran
Intervention MeSH terms: Carbamazepine; Zonisamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Epilepsy; Monotherapy
Polaprezinc Treatment for Enzalutamide- or Abiraterone-resistant CRPC
Condition: Castration-resistant Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate clinical safety and efficacy of a gastric ulcer
      drug, polaprezinc (POL), with the AR-inhibitor abiraterone in Chinese patients with
      castration-resistant prostate cancer (CRPC).
    

Detailed description: 
      Prostate cancer (PCa) is a major disease that affects 14.1% male population worldwide with a
      6.8% mortality rate in 2020 (https://gco.iarc.fr/). In China, the PCa incidence rate is lower
      than in Europe and the US but increases rapidly. Androgen deprivation therapy (ADT) has been
      the most used treatment for men with advanced prostate cancer for decades. Despite the
      initial favorable response, nearly all patients progress to castration-resistant prostate
      cancer (CRPC) and subsequently succumb to the disease within 1-3 years.

      Zinc-L-carnosine (ZnC), also called polaprezinc (otherwise known as PepZin GI™), is a
      chelated compound that contains L-carnosine and zinc. Some reports indicated that POL is
      effective in restoring the gastric lining, healing other parts of the gastrointestinal (GI)
      tract, improving taste disorders, improving GI disorders, and enhancing skin and liver. The
      primary mechanisms of POL action are identified as anti-inflammatory and antioxidant
      pathways. We have identified PRDX5 as a therapeutic target and repurposed polaprezinc (POL)
      as its inhibitor for the treatment of CRPC.

      CRPC patients will be enrolled with their fully informed consent. Patients will be on
      abiraterone/prednisone, abiraterone/prednisone plus polaprezinc granules, or with other
      treatments according to patients' wishes in consultation with physicians. Polaprezinc will be
      75 mg b.i.d., for 6 months. A standard regimen will be used for other treatments. PSA will be
      measured every month. ECT will be taken before and after treatment.
    

Intervention name(s): Polaprezinc group; Control group
Intervention type(s): Drug; Drug
Intervention description(s): Abiraterone plus Polaprezinc for 6 months; Abiraterone, radio- or chemotherapy
Other intervention name(s): POL; OTH
Intervention MeSH terms: Polaprezinc
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be on abiraterone/prednisone plus polaprezinc, or with other treatments according to patients'wishes in consultation with physicians.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CRPC; POL
Atacand Dose Ranging in Hypertensive Pediatric Subjects 1 Year to Less Than 6 Years of Age
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a dose ranging study of candesartan cilexetil in hypertensive pediatric subjects ages
      1 to less than 6 years of age. It employs a double blind, randomized, dose ranging design
      intended for conduct as a multicenter trial. There are 3 study 'periods': a 1-week placebo
      run-in, a 4-week double blind treatment, and a 52-week open-label, long-term treatment
      period. Subjects undergo a screening evaluation, then a 1-week single-blind, placebo run-in,
      after which eligible subjects are allocated to receive 1 of 3 dose levels of candesartan
      cilexetil (0.05 mg/kg, or 0.20 mg /kg or 0.40 mg /kg), liquid formulation, in a 1:1:1 ratio
      for 4-weeks. At the end of randomized dose allocation (Day 28), blood pressure assessment
      will be performed and subjects may begin the 52-week, open-label treatment period of the
      study.
    


Intervention name(s): candesartan cilexetil (Atacand); candesartan cilexetil (Atacand); candesartan cilexetil (Atacand)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.05 mg/kg once daily oral liquid dose; 0.20 mg/kg once daily oral liquid dose; 0.40 mg/kg once daily oral liquid dose
Other intervention name(s): Atacand; ATACAND; ATACAND
Intervention MeSH terms: Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Pediatric hypertension