bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Immunogenicity of GlaxoSmithKline Biologicals' HPV Vaccine 580299 (Cervarix) in HIV Infected Females
Condition: Infections, Papillomavirus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      Infection with human papillomavirus (HPV) has been clearly established as the central cause
      of cervical cancer. The current study is designed to evaluate the safety and immunogenicity
      of GlaxoSmithKline Biologicals' HPV vaccine 580299 in HIV infected adult females living in
      the Republic of South Africa. The study is double blinded, randomized for HIV positive
      subjects and open for HIV negative subjects. The Protocol Posting has been updated in order
      to comply with the FDA Amendment Act, Sep 2007.
    


Intervention name(s): Cervarix; Placebo Control
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular injection, 3 doses; Intramuscular injection, 3 doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: HPV; Human papillomavirus (HPV) vaccine; Human Immunodeficiency Virus (HIV); Cervical cancer; Papillomavirus
Assessment of the Prevalence of TTR Amyloid Neuropathy in a Population of Patients With Neuropathy of Unknown Aetiology
Condition: Familial Amyloid Neuropathy; Transthyretin Amyloidosis
MeSH terms: Peripheral Nervous System Diseases; Amyloid Neuropathies; Amyloid Neuropathies, Familial; Amyloidosis
Study type: Interventional

Summary: 
      Familial amyloid neuropathy due to transthyretin gene mutations (TTR-FAP) is a rare autosomal
      dominant inherited disease resulting in the abnormal multi-system deposition of amyloid
      proteins. These deposits produce a multi-organ disease. AP is usually fatal 10 to 15 years
      after onset of symptoms if untreated. The prevalence of the disease remains still poorly
      understood and usually the search for this pathology is done in a third line of
      investigation. So the average time to diagnosis is extremely long, from 12 to 24 month. Now
      that the investigators have etiological treatment ( famidis (Vyndaqel®) and Diflunisal
      (Dolobid)) of this disease, it is essential to be able to detect FAP patients as early as
      possible. With this study, investigator decided to test for TTR mutation all patients
      presented with neuropathy of unknown etiology at the first line of investigation. The goal of
      this study is to evaluate the prevalence of FAP-TTR among neuropathy and defined the best
      strategy to test this population for TTR mutations.
    


Intervention name(s): blood sample
Intervention type(s): Genetic
Intervention description(s): two 5 ML EDTA tubes of blood will be collected once by patient
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Transthyretin mutation
Effect of Food on PC14586 in Healthy Volunteers and the PK of PC14586 in Healthy Japanese Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2-part Phase 1 cross-over study to assess the effects of food on the
      pharmacokinetics of PC14586 in healthy volunteers. The pharmacokinetics of PC14586 at a
      clinically relevant dose in Japanese participants will also be studied.
    

Detailed description: 
      PC14586 is a first-in-class, oral, small molecule p53 reactivator that is selective for the
      p53 Y220C mutation. This Phase 1 trial will be conducted in 2 parts (Part 1 - pilot and Part
      2 - pivotal) to assess the pharmacokinetics of PC14586 in healthy volunteers including
      Japanese participants.
    

Intervention name(s): PC14586
Intervention type(s): Drug
Intervention description(s): An oral dose of PC14586 will be used in Arms A and B (Part 1) and a different dose will be used for Arms C and D and the Japanese cohort (Part 2).
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Single-dose crossover study one dose with food and one dose without food.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Y220C; PC14586; PMV Pharma; PMV; food effect; Pharmacokinetics; Japanese
Impact of High Protein and Low Carbohydrate Smoothie Drinks in Type-2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      We compared between a regular high protein or a high protein and low carbohydrate smoothie
      drinks with conventional diabetic enteral drinks (Glucerna) on glucose homeostasis, insulin
      and lipid metabolism in type 2 diabetic and obese individuals.
    

Detailed description: 
      We aimed to determine the effect of high protein and low carbohydrate smoothie drinks on
      glucose homeostasis, insulin and lipid metabolism in type 2 diabetic and obese individuals.
      We compared between a regular high protein or a high protein and low carbohydrate smoothie
      drinks with conventional diabetic enteral drinks (Glucerna). A crossover design study was
      done in 60 diabetic participants. Participants consumed 300 kilocalories of each drink at a
      time with one week wash out period between drinks and glucose response curves at baseline,
      30, 60, 90, 120, 180 and 240 minutes were monitored and compared. The products were
      formulated to supply 1 kilocalorie/milliliter (kcal/ml). Dietary compositions in regular
      formulas (smoothie, SM) were 30-40% carbohydrate, 20-30% protein and 30-50% fat. While in
      smoothie with low carbohydrate formulas (SMLS), they were 25-35% carbohydrate, 25-30% protein
      and 35-55% fat vs. a control formula (Glucerna).
    

Intervention name(s): smoothie with regular formulas (SM); smoothie with low carbohydrate formulas (SMLS); conventional diabetic enteral drinks (Glucerna)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Participants were given 300 kcal of smoothie drink within 3-5 minutes and blood collection after drinking at 30, 60, 90, 120, 180 and 240 minutes. Participants have one week wash out period before try-out other formulas.; Participants were given 300 kcal of smoothie drink within 3-5 minutes and blood collection after drinking at 30, 60, 90, 120, 180 and 240 minutes. Participants have one week wash out period before try-out other formulas.; Participants were given 300 kcal of smoothie drink within 3-5 minutes and blood collection after drinking at 30, 60, 90, 120, 180 and 240 minutes. Participants have one week wash out period before try-out other formulas.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: clinical nutrition; smoothie drink; meal replacement; medical food; diabetes; obesity
Comparative Analysis of the Efficacies in Neoadjuvant Chemotherapy of Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the short-term and long-term efficacies and the
      safeties of pirarubicin plus docetaxel(AT group) and pirarubicin plus cyclophosphamide
      followed by docetaxel(AC-T group) in neoadjuvant chemotherapy of breast cancer.
    

Detailed description: 
      Based on the results of NSABP(National Surgical Adjuvant Breast and Bowel Project) B27 trial,
      anthracyclines(A) and Taxanes(T) are most commonly recommended in neoadjuvant chemotherapy of
      breast cancer.

      Pirarubicin is one of anthracyclines and by embedding the DNA double stranded, which inhibits
      DNA replication and RNA synthesis, thereby impedes the rapid growth of cancer cells.

      Docetaxel in one of taxanes and by strengthening the tubulin polymerization, inhibiting of
      microtubule depolymerization and leading to the formation of stable non functional
      microtubule bundles, which destroys mitosis of tumor cells.
    

Intervention name(s): Pirarubicin; Docetaxel; Cyclophosphamide
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Tetrahydropyranyl Adriamycin; Taxotere
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Pirarubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast tumor; Neoadjuvant chemotherapy; Pathological complete remission
FRench-speAking Icu (Intensive Care Unit) Nutritional Survey
Condition: Intensive Care Units (ICUs)
Study type: Observational

Summary: 
      Assessment of nutritional practices in french intensive care units.
    

Detailed description: 
      Assessment of nutritional practices in french intensive care units.
    

Intervention name(s): no intervention
Intervention type(s): Other
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults hospitalized patients in ICU
Pharmacokinetic Drug Interaction Between Ezetimibe and Tacrolimus After Single Dose Administration in Healthy Subjects
Condition: Pharmacokinetics; Drug Interactions; Hypercholesterolemia; Immunosuppression
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to confirm a significant influence of ezetimibe and tacrolimus
      on each others pharmacokinetics
    

Detailed description: 
      Hypercholesterolemia is a frequent finding in organ transplant recipients receiving
      immunosuppressive drugs such as tacrolimus. To prevent increased cardiovascular morbidity and
      mortality in these patients, co-medication with lipid-lowering statins is recommended.
      However, treatment with statins is limited in many patients by insufficient
      cholesterol-lowering efficacy, drug interactions and serious adverse drug reactions (e.g.
      rhabdomyolysis). These patients may benefit from comedication with the cholesterol absorption
      inhibitor ezetimibe. Since tacrolimus and ezetimibe were shown to be substrates of the efflux
      transporter ABCB1 (P-glycoprotein), drug interactions between both compounds may occur.
      Therefore, this clinical study in healthy subjects was initiated to evaluate the clinical
      relevance of drug/drug interactions between tacrolimus and ezetimibe according to the
      accepted bioequivalence approach.
    

Intervention name(s): 1 tablet Ezetrol(R) (ezetimibe), MSD Sharp & Dohme GmbH, Germany; 1 capsule Prograf(R) (tacrolimus), Astellas Pharma GmbH, Germany; 1 tablet Ezetrol(R) + 1 capsules Prograf(R)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): administration of 1 tablet Ezetrol(R) (10 mg ezetimibe), 0-144 h blood sampling, 0-5 d urine sampling (24 h intervals) and 0-10 d feces sampling; administration of 1 capsule Prograf(R) (5 mg tacrolimus), 0-144 h blood sampling; administration of 1 tablet Ezetrol(R) (10 mg ezetimibe) and 1 capsule Prograf(R) (5 mg Tacrolimus), 0-144 h blood sampling, 0-5 d urine sampling (24 h intervals) and 0-10 d feces sampling
Other intervention name(s): Ezetrol; Prograf; Ezetrol+Prograf
Intervention MeSH terms: Ezetimibe; Tacrolimus
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetics; drug interactions; ezetimibe; tacrolimus; human experimentation
Characterization of Local Vascular Effects of LNMMA
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      Characterization of an unexpected venodilative effect of higher L-NMMA-doses in dorsal human
      hand veins.
    


Intervention name(s): L-NMMA(drug)
Intervention type(s): Drug
Intervention MeSH terms: omega-N-Methylarginine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy And Safety Of Parecoxib 40mg vs. Ketoprofen 100mg In The Management Of Acute Renal Colic
Condition: Pain
MeSH terms: Renal Colic
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multicenter, randomized, double blind, double dummy, comparative, active-controlled
      trial designed to assess the analgesic activity and safety of intravenous doses of parecoxib
      40 mg relative to intravenous doses of ketoprofen 100 mg for the treatment of renal colic in
      outpatients presenting at emergency room settings. This trial is designed to show
      non-inferiority of parecoxib related to ketoprofen.
    


Intervention name(s): Ketoprofen 100mg; Parecoxib 40mg
Intervention type(s): Drug; Drug
Intervention description(s): Ketoprofen 100 mg diluted in 100 ml of normal sodium chloride solution into the established patient's IV line by slow injection in a 20-minute period; and IV dose of 2 ml of normal sodium chloride solution as placebo for Parecoxib by bolus injection; Parecoxib 40 mg diluted in 2 ml of normal sodium chloride solution administered by bolus injection; and an IV dose of 100 ml of normal sodium chloride solution as placebo for ketoprofen administered in a in a 20-minute period
Intervention MeSH terms: Ketoprofen; Parecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Renal Colic Pain Urinary Tract Colic
Berberine Hyperglycemic Clamp
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Berberine (BBR) is a traditional Chinese medicine used to treat diabetes mellitus for
      thousands of years in China. The glucose-lowering effect of BBR has been confirmed in
      numerous studies. Nevertheless, the detailed mechanisms of action through which BBR exerts
      its effects are not yet fully elucidated. In previous data, Jin-Kui Yang found that BBR could
      promote insulin secretion in mice and isolated islets. In this current study, investigators
      plan to examine the insulinotropic effect of BBR in human through hyperglycemic clamp method.
    


Intervention name(s): Berberine Chloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Traditional Chinese Medicine; Placebo Control
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Hyperglycemic Clamp
The Effects of Binaural Beats on Pain, Anxiety, and Procedure Tolerance in Patients Undergoing Colonoscopy Without Sedation
Condition: Anxiety State; Patient Satisfaction; Tolerance
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the effect of binaural beats on anxiety, pain
      and tolerance during colonoscopy without sedation
    

Detailed description: 
      It is a prospective randomized, controlled, single-blind procedural study included 92 Turkish
      patients aged 18-70 years old scheduled for colonoscopy regardless of sex or underlying
      disease. The patients were randomly divided into two groups: the binaural beat music
      group(n=46) and the control group(n=46). The binaural music group listened to music through
      headphones during colonoscopy, while the control group had headphones without music. Anxiety
      levels (VAS-Anxiety scale) were measured both before and after the procedure, and pain levels
      (VAS-pain) were measured following the procedure. Hemodynamic changes before and after
      endoscopy , procedure tolerance (using modified gloucester comfort scale), cecal insertion
      and withdrawal times, polyp detection rate, and patients' experiences related to colonoscopy
      were recorded. Likert scales were collected as well just after the colonoscopy procedure,
      indicating satisfaction and willingness to repeat the process.
    

Intervention name(s): binaural music
Intervention type(s): Other
Intervention description(s): In the binaural music group, an MP3 player and in-ear stereo headphones were provided. Music therapy was applied during the procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Comparison of Cardiorespiratory Fitness Among Regular Exercisers With and Without Parkinson Disease and Across Different Modes of Group Exercise
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      The central goal of the proposed study is to generate essential pilot data necessary to
      support an established line of research leading to future extramural grant submissions. The
      aims of the current study are two-fold: 1) to compare cardiorespiratory fitness (CRF) and
      gait endurance across three groups of people: (1) individuals with Parkinson Disease (PD) who
      participate in boxing on a regular basis, (2) individuals with PD who participate in exercise
      other than boxing on a regular basis and (3) healthy controls of the same age who exercise on
      a regular basis and 2) to examine the relationship between CRF and motor symptoms of PD
      (bradykinesia, tremor and postural instability). Forty-five participants (15 for each group)
      who participate in exercise on a regular basis (at least 120 minutes of exercise per week for
      the past 3 months) will be recruited for this cross-sectional study. In a single testing
      session, participants will perform the following tests: (1) clinical performance measures and
      (2) a CRF assessment. A one-way ANOVA with appropriate post hoc tests will be used to examine
      differences in dependent variables across the three exercise groups. Relationships between
      CRF and clinical performance measures will be evaluated with Pearson's correlation
      coefficients.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A total of 45 individuals will be enrolled in this cross-sectional study. Three groups will
        each consist of 15 individuals (individuals with Parkinson Disease that participate in
        boxing, individuals with Parkinson disease that participate in group exercise other than
        boxing, and individuals without disability that participate in group exercise other than
        boxing).
      
Keywords: cardiorespiratory fitness; group exercise
Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Oral Pf-06650833 In Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Controlled, Sequential Group,
      Multiple Ascending Dose Escalation Study To Evaluate The Safety, Tolerability, And
      Pharmacokinetics Of Orally Administered PF-06650833 In Healthy Subjects
    


Intervention name(s): PF-06650833; Placebo; PF-06650833; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Suspension; Suspension; Tablet (Modified Release); Tablet (Modified Release)
Allocation: Randomized
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Thermosensitive Gels for the Vaginal Delivery of Sildenafil Citrate
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this study was to develop and characterize in situ thermosensitive gels for the
      vaginal administration of sildenafil as a potential treatment of the endometrial thinning
      that occurs as a result of the use of clomiphene citrate in induction of ovulation in women
      with World Health Organization type II EU gonadotrophic anovulation.
    


Intervention name(s): preparation F12 sildenafil in situ gel; preparation F2 sildenafil in situ gel; placebo gel
Intervention type(s): Drug; Drug; Drug
Intervention description(s): in situ vaginal gel; in situ vaginal gel; vaginal gel
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study of Certolizumab Pegol to Evaluate Pharmacokinetics and Safety in Adult Healthy Chinese Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will characterize the pharmacokinetics (PK) of certolizumab pegol (CZP) and
      evaluate safety of CZP in healthy Chinese subjects. 36 subjects will be randomized to receive
      one of 3 dose levels of CZP or placebo. The total study duration will be approximately 71-94
      days for each subject.
    

Detailed description: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, single-center, single
      escalating dose study in healthy Chinese subjects. The primary objective of the study is to
      characterize the pharmacokinetics (PK) of certolizumab pegol (CZP) in healthy Chinese
      subjects after a single subcutaneous (sc) dose. The secondary objective is to evaluate safety
      of CZP in healthy Chinese subjects after a single sc dose. 36 healthy Chinese subjects (18
      male and 18 female) will be randomized to receive one of 3 dose levels of CZP (100 mg, 200 mg
      and 400 mg) or placebo given by sc injections. Each dose group begins treatment staggered by
      a minimum of 14 days. The total duration of the study will be approximately 71 to 94 days for
      each subject. This includes a 2 to 21 days Screening Period, 1 day of treatment and 70 days
      Observation Period after administration of a single dose of investigational medicinal
      product.
    

Intervention name(s): Certolizumab Pegol; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Active Substance: Certolizumab Pegol
Pharmaceutical Form: Prefilled syringes
Concentration: 200 mg/mL
Route of Administration: Subcutaneous injection; Active Substance: Placebo
Pharmaceutical Form: Prefilled syringes
Concentration: 0.9 % Saline
Route of Administration: Subcutaneous injection
Other intervention name(s): Cimzia; CDP870; CZP; PBO
Intervention MeSH terms: Certolizumab Pegol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Certolizumab Pegol; Healthy Chinese subjects