bioihbjkbjnl/mcl2 huggingface dataset:
Nicotine's Potential Abuse With Menthol
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To examine if switching from menthol to non-menthol cigarettes will change the dose-effect
      curves for positive subjective effects and alleviation of smoking urges as a function of
      nicotine delivery rate in smokers.
    

Detailed description: 
      A placebo-controlled study that will recruit male and female menthol nicotine dependent
      smokers. Following screening and evaluation as described above, eligible participants will be
      enrolled in the study which will last about 4 weeks. Eligible, participants will be
      randomized to menthol or non-menthol smoking condition for 2 weeks (Phase 1) and then will be
      switched to the alternative condition for another 2 weeks (Phase 2). The smoking condition
      will be open label. Participants will be provided with free cigarettes in Phases 1 and 2. For
      the menthol condition, participants will be provided their usual brand of menthol cigarettes
      and for the non-menthol condition, they will be provided a matched-brand non-menthol
      cigarette (e.g., Newport Non-Menthol Gold 100s for those who smoke Newport Menthol Gold
      100s). In week 2 of each Phase, participants will have a test session. Each session will
      include 3 infusions in the same order: nicotine (1 mg per 70 kg body weight) delivered over 5
      minutes, saline and nicotine (1 mg/ 70 kg) delivered over 2.5 minutes. Once the participants
      complete the test session, participants will be crossed-over to the alternative treatment.
      The period between the 2 Phases will not be longer than one week.
    

Intervention name(s): Nicotine
Intervention type(s): Drug
Intervention description(s): session will include 3 infusions in the same order: nicotine (1 mg per 70 kg body weight) delivered over 5 minutes, saline and nicotine (1 mg/ 70 kg) delivered over 2.5 minutes.
Other intervention name(s): intravenous nicotine
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: subjects will be unblinded to smoking menthol or non menthol for two weeks before each test session. Each session will include 3 infusions in the same order: nicotine (1 mg per 70 kg body weight) delivered over 5 minutes, saline and nicotine (1 mg/ 70 kg) delivered over 2.5 minutes. Once the participants complete the test session, participants will be crossed-over to the alternative treatment.
Masking: Single (Participant)
Primary purpose: Health Services Research
Correlation and Comparison of the HepQuant® Disease Severity Index (DSI) With Hepatic Venous Pressure Gradient (HVPG)
Condition: Liver Disease
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      This study plans to learn more about a new test to look at liver function, the HepQuant-Shunt
      (HQ-Shunt). The HQ-Shunt is being evaluated for safety and effectiveness as an alternative to
      Hepatic Venous Pressure Gradient testing in patients with liver disease.
    

Detailed description: 
      The goal of this study is to demonstrate the HQ-SHUNT is safe, simple to administer,
      noninvasive, cost-effective, and well tolerated by patients. This study will compare the
      HQ-SHUNT to Hepatic Venous Pressure Gradient (HVPG) testing. In this study, 100 consecutive
      patients with various etiologies of liver disease who have undergone technically successful
      HVPG testing as standard of care will also undergo HQ-SHUNT testing.
    

Intervention name(s): HepQuant-SHUNT (Drug and Device) #65,123 (4D-cholate) and IND #65,121 (13C-cholate); Hepatic Venous Pressure Gradient (HVPG)
Intervention type(s): Drug; Device
Intervention description(s): The HQ-SHUNT test is being evaluated for safety and effectiveness as an alternative to Hepatic Venous Pressure Gradient (HVPG) testing in patients with liver disease; Hepatic Venous Pressure Gradient (HVPG) is a test for patients with liver disease
Other intervention name(s): HQ-SHUNT; (HVPG)
Intervention MeSH terms: Cholic Acids
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Hepatic Venous Pressure Gradient (HVPG) testing; HepQuant-SHUNT; Liver Function
Bioavailability Study of Anastrozole Tablets 1 mg of Dr.Reddy's Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare bioavailability in healthy, post menopausal women
      subjects under fasting conditions.
    

Detailed description: 
      Open label, balanced, randomized, two treatment, two-sequence, two periods, crossover, single
      dose, comparative oral bioavailability study in healthy, post menopausal women subjects under
      fasting conditions.
    

Intervention name(s): Anastrozole
Intervention type(s): Drug
Intervention description(s): Anastrozole Tablets 1 mg of Dr.Reddy's Laboratories Limited
Other intervention name(s): Arimidex® Tablets 1 mg
Intervention MeSH terms: Anastrozole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioavailability; Anastrozole; Crossover
Safety and Efficacy Study of Q301 in Mild to Moderate Adolescents and Adults Atopic Dermatitis Patients
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, vehicle-controlled, parallel-group comparison study to
      evaluate the safety and efficacy of Q301 Cream vs. vehicle in adolescent and adult subjects
      with mild to moderate AD. Study drug (Q301 Cream or vehicle) will be administered topically
      twice a day for 8 consecutive weeks.
    


Intervention name(s): Q301 Cream; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): 1.0% or 1.4% Q301 Cream; Vehicle Control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Bioequivalence Study of Dutasteride Capsules in Healthy Japanese Male Subjects
Condition: Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a single center, open-label, single dose, randomized and 2-way crossover study
      in healthy Japanese male subjects under fasting conditions. The study will be conducted to
      determine the bioequivalence between dutasteride capsules manufactured at GSK (test product)
      and dutasteride capsule manufactured at Catalent (reference product) in healthy Japanese male
      subjects. Subjects will have a screening visit within 30 days prior to the first dose of
      study treatment, two treatment periods separated by 28-days washout period, a re-visit 10-14
      days after the second dose for the first follow-up and a second follow up via telephone 50-54
      days after the second dose. The total duration of the study will be approximately 15 weeks
      from screening to the second follow up.
    


Intervention name(s): Dutasteride-Test product; Dutasteride-Reference product
Intervention type(s): Drug; Drug
Intervention description(s): Dutasteride Capsules are oblong, opaque, dull-yellow, gelatin capsules. The capsules contain 0.5 mg dutasteride for oral administration. The capsules also contain Butylated Hydroxytoluene, Mono-di-glycerides of Caprylic/Capric Acid (MDC), Gelatin, Concentrated Glycerin, Titanium Dioxide, Iron Oxide Yellow as ingredients. This product will be manufactured by GSK, Poznan.; Dutasteride Capsules are oblong, opaque, dull-yellow, gelatin capsules. The capsules contain 0.5 mg dutasteride for oral administration. The capsules also contain Butylated Hydroxytoluene, Mono-di-glycerides of Caprylic/Capric Acid (MDC), Gelatin, Glycerin, Concentrated Glycerin, Titanium Dioxide, Iron Oxide Yellow as ingredients. This product will be manufactured by Catalent, Beinheim.
Intervention MeSH terms: Dutasteride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Fasted state; Japanese male healthy subjects; Dutasteride
Comparison of Two Liraglutide Formulations in Healthy Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of the
      phase 3a formulation of liraglutide at pH 8.15 (formulation 4) and liraglutide at pH 7.7
      (formulation 3).
    


Intervention name(s): liraglutide; liraglutide
Intervention type(s): Drug; Drug
Intervention description(s): One single dose of 6.25 mg/mL administered subcutaneously; One single dose of 6.0 mg/mL administered subcutaneously
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Epoprostenol for Injection in Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective, multi-center, open-label, randomized, Phase IV exploratory study
      comparing safety, tolerability, pharmacokinetics, and effectiveness of ACT-385781A and Flolan
      (epoprostenol sodium) in patients with pulmonary arterial hypertension who are naïve to
      injectable prostanoid treatment and in need of such treatment. Approximately 30 patients from
      8 U.S. clinical sites will be randomized to receive either ACT-385781A or Flolan (2:1
      respectively) for 28 days of treatment.
    


Intervention name(s): ACT-385781A (Actelion Epoprostenol); Flolan®
Intervention type(s): Drug; Drug
Intervention description(s): per Prescribing Information; Per Prescribing Information
Intervention MeSH terms: Epoprostenol; Tezosentan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pulmonary Arterial Hypertension; PAH; EPITOME-1
Efficacy and Safety of the Neodymium Laser in Treatment of Urogenital Tract Diseases in Women
Condition: Genitourinary Syndrome of Menopause; Pelvic Floor Dysfunction; Vulvar Lichen Sclerosus
MeSH terms: Vulvar Lichen Sclerosus; Lichen Sclerosus et Atrophicus
Study type: Observational

Summary: 
      Study objective: To evaluate the efficacy and safety of the Magic Max neodymium laser in the
      medical treatment of women with symptoms of genitourinary syndrome of menopausal, vulvar
      lichen sclerosus and pelvic floor muscle reduction.
    

Detailed description: 
      Study objective: To evaluate the efficacy and safety of the Magic Max neodymium laser in the
      medical treatment of women with symptoms of genitourinary syndrome of menopausal, vulvar
      lichen sclerosus and pelvic floor muscle reduction.

      Materials and methods: 60 patients with diseases of the urogenital tract were enrolled into
      the study; they were treated with a neodymium (ND) laser: three 20-minute sessions every 28 ±
      2 days. Efficacy was assessed by means of the Female Sexual Function Index (FSFI), ICIQ-SF,
      PISQ-12, SF36 survey forms, and a questionnaire to identify urinary disorders at the
      following time points: before treatment, one month after each session and 6 months after the
      last procedure.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        patients with diseases of the urogenital tract were enrolled into the study;women with
        symptoms of genitourinary menopausal syndrome, vulvar lichen sclerosus and pelvic floor
        muscle reduction
      
Keywords: neodymium laser, GUMS, lichen sclerosus
Evaluation of the Inflammatory and Healing Profile After Root Coverage With Emdogain®
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was the evaluation of inflammatory and healing profile after root
      coverage using of Enamel Matrix Derivative. 16 volunteers were selected and submitted to root
      coverage surgery with subepithelial connective tissue graft, with and without enamel matrix
      derivative. The patient screening was based in the following inclusion criteria: bilateral
      recessions in maxillary anterior homologous teeth with aesthetical complaining ou
      hypersensitivity, non-smokers, healthy and no use of any medication that compromises
      periodontal health or healing. The split-mouth randomized model was followed in relation to
      test and control sites. The following clinical parameters were analyzed at baseline and
      6-month post-surgery: recession height, recession width, width of keratinized tissue, probing
      depth, clinical attachment level, and gingival thickness. In addition to the surgical
      analysis, evaluations of the following inflammatory markers were performed: IL-1β, IL -1RA,
      IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL12, IL-13, IL-15, IL-17, EOTAXIN, FGF,
      GCSF, GMCSF, IFN-y, IP-10, MCP-1, MIP 1a, PDGF-bb, MIP 1b, RANTES, TNF-α e VEGF. These
      evaluations were performed at baseline, 7 and 14 days after surgery.
    


Intervention name(s): Microsurgery technique for root coverage; Microsurgery technique for root coverage associated to EMD
Intervention type(s): Procedure; Biological
Intervention description(s): Microsurgery technique for root coverage adapted for macrosurgery; Microsurgery technique for root coverage adapted for macrosurgery associated to Enamel Matrix Derivative
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Gonadotropin-releasing Hormone Agonist Prior to Myomectomy
Condition: Fibroids
MeSH terms: Leiomyoma
Study type: Interventional
Phase: Phase 3

Summary: 
      Fibroids are common in the West Indian population (30-40% of reproductive women).Fibroids are
      benign growth in the womb or uterus and in order to preserve the fertility of women they,
      require an operation called myomectomy or shelling out of the fibroid. This procedure can be
      associated with large blood loss.

      In current practice some obstetricians use a gonadotropin releasing hormone agonist prior to
      the operation to reduce blood loss. Gonadotropin releasing hormone agonist is used in current
      gynaecological practice to treat women with heavy periods.

      In this study the investigators randomised women to either 2 or 3 doses of the gonadotropin
      agonist prior to their operation and no treatment. The intraoperative blood loss was
      measured. The study hypothesis: To determine whether administration of gonadotropin releasing
      hormone agonist prior to myomectomy reduces intraoperative blood loss.
    

Detailed description: 
      Variables noted preoperatively:

        -  Age

        -  Parity

        -  Ethnicity

        -  Ultrasound findings

      Variables noted intra-operatively:

        -  Size of largest fibroid

        -  Estimated blood loss
    

Intervention name(s): 2 Doses Goserelin; 3 Doses Goserelin
Intervention type(s): Drug; Drug
Intervention description(s): 3.6mg administered monthly for 2 months prior to myomectomy; 3.6mg administered monthly for 3 months prior to myomectomy
Other intervention name(s): Gonadotropin Releasing Hormone Agonist; Gonadotropin Releasing Hormone Agonist
Intervention MeSH terms: Goserelin; Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: myomectomy; GnRH; blood loss
Clinical Study of a Personalized Neoantigen Cancer Vaccine in Treating Patients With Advanced Pancreatic Cancer
Condition: Pancreatic Cancer; Pancreatic Carcinoma
MeSH terms: Pancreatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This research study is evaluating a new type of pancreatic cancer vaccine called
      "Personalized Neoantigen Cancer Vaccine" as a possible treatment for advanced pancreatic
      cancer. The purpose of the clinical study is evaluating the safety, tolerability and partial
      efficacy of the personalized neoantigen cancer vaccine in the treatment of Chinese patients
      with advanced pancreatic cancer, so as to provide a new personalized therapeutic strategy for
      advanced pancreatic cancer patients.

      It is known that cancer patients have mutations (changes in genetic material) that are
      specific to an individual patient and tumor. These mutations can cause the tumor cells to
      produce proteins that appear very different from the body's own cells. It is possible that
      these proteins used in a vaccine may induce strong immune responses, which may help the
      participant's body fight any tumor cells that could cause the cancer to come back in the
      future. The study will examine the safety of the vaccine when given at several different time
      points and will examine the participant's blood cells for signs that the vaccine induced an
      immune response.
    


Intervention name(s): iNeo-Vac-P01; GM-CSF
Intervention type(s): Biological; Other
Intervention description(s): Neoantigen peptides; immune adjuvant
Other intervention name(s): granulocyte-macrophage colony stimulating factor
Intervention MeSH terms: Molgramostim; Sargramostim
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neoantigen, Pancreatic Cancer, iNeo-Vac-P01,Peptide Vaccine
Efficacy of Nonselective Beta Blocker vs Placebo in Patients With Acute-on-chronic Liver Failure With Small/ no Esophageal Varices
Condition: Acute on Chronic Liver Failure
MeSH terms: Liver Failure; Hepatic Insufficiency; End Stage Liver Disease; Acute-On-Chronic Liver Failure; Esophageal and Gastric Varices
Study type: Interventional

Summary: 
      Acute on chronic liver failure patients with HVPG (Hepatic Venous Pressure Gradient) ≥ 12
      mmHg + No/small esophageal varices who present to the Department of Hepatology at Institute
      of Liver and Billiary Sciences, who meet the inclusion criteria and who provide informed
      consent.
    


Intervention name(s): Carvedilol; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Carvedilol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MEC90 for Supra-inguinal Fascia Iliaca Block Performed Under Ultrasound Guidance in Arthroscopic Knee Surgery
Condition: Pain Management
Study type: Interventional

Summary: 
      In this study, the minimum effective concentration required for supra-inguinal fascia iliaca
      block applied in patients undergoing arthroscopic knee surgery is aimed. The same volume will
      be used in all of the block applications in the study, and the local anesthetic concentration
      used will be determined by increasing or decreasing according to the success of the previous
      block. The primary goal of the study is block success.
    

Detailed description: 
      For patients included in the study, 40 mL of local anesthetic will be used for SIFIB. The
      local anesthetic concentration will be randomized using the biased-coin design up-down
      sequential method, as suggested by Durham et al. and described by Dixon.

      The primer outcome of this study is block success. Also, the incidence of motor block
      formation in the quadriceps muscle (to be defined as paresis or paralysis in knee extension),
      the amount of tramadol needed in 24 hours, opioid-related side effects (postoperative
      nausea/vomiting, itching), length of hospital stay and complications that may develop related
      to the block will be recorded.
    

Intervention name(s): Regional Anesthesia Techniques
Intervention type(s): Other
Intervention description(s): Fascial Plane Blocks
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: As suggested by Durham et al and described by Dixon, study randomization will be performed using the biased-coin design up-down sequential method.
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Supportive Care
Peripheral Muscle Function in Patients With COPD
Condition: Copd
Study type: Observational

Summary: 
      Chronic obstructive pulmonary disease (COPD) is characterized by irreversible airway
      obstruction and progressive deterioration of respiratory function. Patients with COPD show a
      limited exercise tolerance, early fatigability and progressive dyspnea, with important
      consequences on the ability to sustain even mild efforts and a drastic restriction in the
      activities of daily living. Muscle dysfunction is a systemic manifestation of COPD that
      contributes to exertion intolerance in individuals with COPD to the point of compromising
      fundamental functional activities, such as walking. Previous studies have shown, in fact,
      that quadriceps strength can be reduced by 20% to 30% in patients with COPD and this value is
      associated with an increased risk of mortality in patients with lower strength levels. In
      addition, loss of muscle mass or sarcopenia also occurs with a prevalence of between 8% and
      67% in patients with COPD, exacerbating the picture of muscle dysfunction.

      One of the goals of respiratory rehabilitation is precisely the prevention of muscle
      dysfunction in patients with COPD. However, rehabilitation programs aimed at maintaining and
      recovering muscle strength are often lacking in guidance regarding target muscles, duration
      of sessions, and training intensity, while strength assessment is often limited by the timing
      and resources associated with the clinical setting in which it takes place. This makes it
      difficult to determine its short- and long-term effectiveness.

      Therefore, assessment of muscle function in patients with COPD requires tests that are simple
      and quick to perform, but equally capable of providing quantitative data referable to a
      specific characteristic of muscle strength as well as indicative of the patient's overall
      function. In addition, complementary measurements such as body composition and muscle mass,
      as well as the development of predictive models and normative values of muscle function could
      provide additional information on the progression of muscle dysfunction in patients with
      COPD, allowing rehabilitation intervention to be directed toward recovery of the most
      compromised functions.

      Therefore, the aims of this study are: 1) To evaluate the effectiveness of a standard
      pulmonary rehabilitation program in recovering peripheral muscle dysfunction in patients with
      COPD. 2) To evaluate the clinical reliability of tests commonly used to measure peripheral
      muscle function in the rehabilitation setting of patients with COPD.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Outpatients with COPD referred to the Cardiopulmonary Rehabilitation Unit of a tertiary
        referral sub-acute rehabilitation centre.
      
Keywords: Copd; Pulmonary rehabilitation; Muscle strength