bioihbjkbjnl/mcl2 huggingface dataset:
A Phase II Trial of Tadalafil in Patients With Squamous Cell Carcinoma of the Upper Aero Digestive Tract
Condition: Head and Neck Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 2

Summary: 
      Head and neck squamous cell carcinoma (HNSCC) is a lethal solid malignancy with 5 year
      survival estimates of approximately 50%, and is associated with a high rate of systemic
      immune impairment as well as evasion of a tumor specific immune response. Preclinical and
      clinical data have shown that phosphodiesterase 5 (PDE5) inhibitors (tadalafil) can be used
      to augment immune function in HNSCC patients through inhibition of the cancer-induced myeloid
      derived suppressor cells (MDSCs).

      A multi site phase II, randomized, prospective, biomarker endpoint trial to determine optimum
      timing and design of PDE5 antitumor immunotherapy (tadalafil) in conjunction with
      conventional therapy for HNSCC.

      40 patients with biopsy proven HNSCC will be randomized to receive tadalafil (n=25) or
      placebo (n=15) for at least 10-14 days before starting conventional therapy and continuing
      until 90 days after completion of conventional therapy. Tumor-specific T cell responses will
      be assessed using HNSCC cell lines, in blood collected before initiation of tadalafil/placebo
      and at 60 and 90 days after completion of conventional therapy. Number and function of MDSC
      and Treg cells will be assessed before and at 60 and 90 days after completion of conventional
      therapy. Prevnar 13® vaccine will be administered 10-14 days after commencing
      tadalafil/placebo (before conventional therapy begins) and again at 60 days after completion
      of conventional therapy. Vaccine-specific responses assessed at 60 and 90 days
      post-conventional therapy will be used to measure the ability of tadalafil to augment immune
      response to vaccine.
    


Intervention name(s): Tadalafil; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Cialis
Intervention MeSH terms: Tadalafil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pharmacotherapy and Psychotherapy in the Treatment of Erectile Dysfunction
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional

Summary: 
      The study involved the administration of pharmacotherapy and cognitive behavior psychotherapy
      to individuals suffering from erectile dysfunction. The study was randomized controlled trial
      with four arms involving a control group.
    


Intervention name(s): Sildenafil Citrate 50Mg Tab; Cognitive Behavioral Psychotherapy; Combined or Integrated Therapy; Placebo
Intervention type(s): Drug; Behavioral; Combination Product; Other
Intervention description(s): The Group A received sildenafil citrate 50 mg on demand for a period of max 3 months.; The Group B received cognitive behavior psychotherapy for a period of max 3 months.; The Group C received the combined therapeutic approach for a period of max 3 months.; The Group D received no treatment or placebo for a period of max 3 months.
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Other
Non-interventional, Real Life Study on Satisfaction With LNG-IUS in Spanish Young Women (18-30 Years Old) With Different Parity Status and Menstrual Bleeding Pattern
Condition: Contraception
MeSH terms: Hemorrhage
Study type: Observational

Summary: 
      The aim of this non-interventional study (NIS) is to assess, under real-life conditions,
      woman's satisfaction with Levonogestrel IntraUterine System (LNG-IUS) in a young (18-30 years
      old (y.o.)) Spanish population taking into account their parity status.

      Furthermore, the study is aimed to evaluate the impact of: menstrual bleeding pattern and
      satisfaction with it at baseline, LNG-IUS chosen, previously used contraceptive method and
      reasons for change to/ choice of a LNG-IUS on overall satisfaction with LNG-IUS use.
    


Intervention name(s): Levonogestrel IntraUterine System (LNG-IUS)
Intervention type(s): Drug
Intervention description(s): At the routine clinical practice. Jaydess, Mirena, Kyleena Or any other levonogestrel intrauterine system (LNG-IUS) commercialized in Spain at the start of the study, only for contraception indication.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be women in childbearing age between ≥18 to 30 years, who have freely
        chosen a LNG-IUS for contraception after being adequately counselled and informed of all
        contraceptive options by their physician at a routine visit prior to the first study visit
        (enrolment) in a routine clinical practice setting. Then, women eligible for the enrolment
        will be visiting the physician in a IUS insertion visit in a gynaecological clinical
        setting.
MK0653A (Ezetimibe (+) Simvastatin) Compared to an Approved Drug (Atorvastatin) for the Treatment of High Cholesterol (0653A-051)(COMPLETED)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to assess the safety and efficacy of an investigational drug as compared to an
      approved drug to reduce specific cholesterol levels.
    

Detailed description: 
      The duration of treatment is 6 weeks.
    

Intervention name(s): MK0653A, ezetimibe (+) simvastatin; Comparator: atorvastatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atorvastatin; Simvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of Treprostinil and a New Formulation of LY900014 in Healthy Japanese Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aims of this study are to evaluate:

        -  The safety and tolerability of a single dose of treprostinil given subcutaneously (as an
           injection just under the skin)

        -  The pharmacokinetic profile (how the body absorbs, breaks down, and gets rid of) of a
           single subcutaneous dose of a new LY900014 formulation in healthy Japanese participants.

      The study has two parts. Participants may only enroll in one part.
    


Intervention name(s): Treprostinil; Placebo; LY900014; Insulin Lispro
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered SC.; Administered SC.; Administered SC.; Administered SC.
Other intervention name(s): Ultra-Rapid Lispro
Intervention MeSH terms: Insulin Lispro; Treprostinil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Study of Faldaprevir, Ribavirin and TD-6450 in Participants With Genotype 4 Hepatitis C Virus Infection
Condition: Hepatitis C Viral Infection; Chronic Hepatitis C; Hepatitis C (HCV); Hepatitis C Genotype 4
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Virus Diseases; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase 2a study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir
      and TD-6450 in combination with Ribavirin for a 12-week treatment duration in treatment-naïve
      participants with genotype 4 hepatitis C virus (HCV) infection.
    

Detailed description: 
      A study to evaluate the safety and effect of treatment with experimental antiviral drugs in
      combination with ribavirin in treatment-naïve participants with genotype 4 hepatitis C
      infection. The study will test the safety and effects of this alternative treatment for up to
      12 weeks. Secondary objectives of this study are to determine the pharmacokinetics of the
      study drugs when co-administered, and to evaluate HCV RNA kinetics during treatment.
    

Intervention name(s): Faldaprevir; TD-6450; Ribavirin
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): BI 201335; Ribasphere®
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Tolerability of Retinoid QLT091001 in Healthy Volunteers
Condition: Healthy Human Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Healthy volunteer subjects will receive retinoid QLT091001 once-daily for 7 days for safety
      observation.
    


Intervention name(s): QLT091001
Intervention type(s): Drug
Intervention description(s): 7-day repeated dose
Intervention MeSH terms: Retinol acetate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Safety of the Etonogestrel-releasing Implant During the Puerperium of Healthy Women
Condition: Breastfeeding; Contraception
Study type: Interventional

Summary: 
      The purpose of this study to assess the safety of the etonogestrel-releasing subdermal
      implant (Implanon) inserted during the immediate puerperium of healthy women.
    

Detailed description: 
      Many contraceptive methods are currently available. However, about 50% of all pregnancies in
      the world are not planned, most of them occurring in developing countries. Long-lasting
      reversible contraceptives such as the etonogestrel implant represent an option for the
      reduction of unwanted pregnancies, especially among patients at risk for a short
      intergestational period. In addition to preventing an undesired pregnancy, these methods have
      an impact on the reduction of the maternal-fetal morbidity-mortality known to be associated
      with these short intervals, also minimizing the malnutrition and the cycle of poverty caused
      by multiparity.

      On the basis of inclusion and exclusion criteria, we will selected 40 puerperae aged 18 to 35
      years at the Low Risk Prenatal Care Program of the University Hospital of Ribeirão Preto,
      University of São Paulo (HC-FMRP). The subjects will be randomized to two types of treatment
      (etonogestrel-releasing implant to be inserted 24 to 48 hours after delivery or 150 mg
      medroxyprogesterone administered every three months starting 6 weeks after delivery). Blood
      samples (40 mL) will be collected in a single procedure from these patients and stored for
      later determination of multiple hemostatic and metabolic variables at 24-48 hours and at 6
      and 12 weeks after delivery. Data on maternal and neonatal clinical parameter will be also
      collected.
    

Intervention name(s): etonogestrel implant; depot medroxyprogesterone acetate
Intervention type(s): Drug; Drug
Intervention description(s): Etonogestrel-releasing subdermal implant (Implanon) inserted during the immediate postpartum period (from 24 to 48 hours postpartum); 150 mg medroxyprogesterone administered I.M. every three months starting 6 weeks after delivery
Other intervention name(s): Implanon, Etonogestrel implant; medroxyprogesterone
Intervention MeSH terms: Medroxyprogesterone Acetate; Medroxyprogesterone; Desogestrel; Etonogestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Adverse Effects; Etonogestrel; Postpartum period; Contraception; Hemostasis; Metabolism
Ketamine Infusion as Sedative Analgesic in Severe ARDS
Condition: Intensive Care Unit Syndrome; Mechanical Ventilation Complication; Sedatives and Hypnotics Causing Adverse Effects in Therapeutic Use; Delirium
MeSH terms: Delirium
Study type: Observational

Summary: 
      To evaluate whether ketamine is a safe sedative-analgesic agent to be used in an intensive
      care unit (ICU) setting as compared to traditionally used agents such as propofol, opioids,
      and midazolam
    

Detailed description: 
      According to the 2018 Clinical Practice Guidelines for the prevention and management of pain,
      agitation/sedation, delirium, immobility, and sleep disruption in adult patients in the
      intensive care unit (ICU), nonbenzodiazepine sedatives (such as propofol and dexmedetomidine)
      are preferable to benzodiazepine sedatives (such as midazolam and lorazepam) in critically
      ill, mechanically ventilated patients. Moreover, continuous use of benzodiazepine (more than
      48 hours) has been associated with a risk of prolonged sedation and delirium. On the other
      hand, though propofol has a remarkable safety profile, it carries unfavorable side effects
      such as dose-dependent hypotension, hypertriglyceridemia, pancreatitis, and propofol syndrome
      (which is a rare but potentially fatal complication, associated with high-dose propofol
      infusions, and characterized by severe metabolic acidosis and circulatory collapse).

      During the coronavirus disease 2019 (COVID-19) pandemic, an enormous number of patients
      required mechanical ventilation, which led to the shortage of traditional sedatives such as
      propofol, dexmedetomidine, midazolam, and lorazepam in the hospitals. In this challenging
      time, ketamine was used as an alternative sedative infusion. This study is to evaluate
      whether ketamine is safer compared to other sedatives in severe COVID related ARDS patients.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study includes patients who are on mechanical ventilators and classified as moderate
        to severe ARDS with a PF ratio < 150.
      
Keywords: ketamine; Mechanical ventilation; sedative analgesic; hospital length of stay; Number of ventilator days; mortality
Phase 1 Study to Determine Safety, Blood PK and Lung Penetration
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Multiple center, double-blind, randomized, placebo-controlled study to see if it is safe to
      give ACHN-490 Injection for 5 consecutive days, to measure plasma pharmacokinetics, and to
      determine lung penetration of ACHN-490 (measured in ELF-epithelial lining fluid)after a
      single dose of ACHN-490 Injection in healthy volunteers.
    


Intervention name(s): ACHN-490 Injection; Placebo (normal saline)
Intervention type(s): Drug; Drug
Intervention description(s): ACHN-490 Injection at 15mg/kg is given either 1 or 5 consecutive days. Cohort 1 receives 5 consecutive days of treatment and Cohort 2 receives a single dose of treatment.; Placebo is given at the same volume as ACHN-490 Injection to maintain the blind.
Other intervention name(s): Normal Saline; NS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Human volunteers
Cognitive Rehabilitation of Executive Dysfunction - Goal Management Training in Patients With Acquired Brain Injury
Condition: Brain Injuries
MeSH terms: Brain Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The main objective of this study is to examine the effect of Goal Management Training for
      patients with executive difficulties after acquired brain injury in a randomized controlled
      trial. The effect on cognitive functioning will be examined, as will the relationship between
      treatment effects and lesion location and size. The effect of Goal Management training on
      regulating emotions, quality of life and coping will be examined. The generalizability of
      treatment effects across etiologies will be explored by comparing effects in three patient
      groups; traumatic brain injury, cerebrovascular accidents and resected brain tumors.
      Structural Magnetic Resonance Imaging (MRI) scans and measures of white matter connectivity
      will be used to establish detailed lesion descriptions. Functional MRI data will provide
      information on the neural underpinnings of treatment related change. A secondary objective is
      to expand the Goal Management Training protocol with increased focus on emotional regulation
      and adherence to homework assignment.
    


Intervention name(s): Goal Management Training; Brain Health Workshop
Intervention type(s): Other; Other
Intervention description(s): Goal Management training, 8 sessions of 2 hours; Brain Health Workshop training, 8 sessions of 2 hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Transoral Gastric Volume Reduction as an Intervention for Weight Management
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, technical feasibility, and initial
      effectiveness (i.e., weight loss primarily measured as percent excess weight loss) of TGVR
      performed using the Bard RESTORe Suturing System
    


Intervention name(s): RS2 (RESTORe Suturing System)
Intervention type(s): Device
Intervention description(s): Suturing in stomach
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight Loss; Transoral Suturing; Experimental
Strength Training for Older Breast Cancer Survivors
Condition: Breast Neoplasm; Osteoporosis, Postmenopausal
MeSH terms: Breast Neoplasms; Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional

Summary: 
      Women aged 50 and older are disproportionately affected by breast cancer, not only in terms
      of new diagnoses, but also in terms of survivorship. Approximately 85% of women who receive a
      first diagnosis of breast cancer are aged 50 and over, thus older women constitute the
      largest group of breast cancer survivors. Yet, few studies have focused on evaluating whether
      physical activity and exercise interventions affect long-term symptoms, physical fitness and
      function, and body composition of older breast cancer survivors. Due to the combined effects
      of breast cancer, related treatments and aging it is likely that exercise is even more
      beneficial for older breast cancer survivors than for younger survivors. Along with the
      cancer-related symptom of fatigue common to cancer survivors, older survivors face
      age-related declines in bone and muscle mass, muscle strength, bone health and physical
      function (gait and balance) that are likely exacerbated by reduced physical activity in
      survivorship and side effects of adjuvant cancer treatment. All women, regardless of age, are
      at risk for breast cancer recurrence. Recent epidemiologic evidence suggests a link between
      exercise and reduced risk of cancer recurrence in breast cancer survivors. Strength training
      is specifically suited to reverse or slow age-related declines in bone, muscle, strength and
      function and has shown promise to reduce cancer-related fatigue. However, no controlled
      trials of strength training in older breast cancer survivors have been conducted.
    


Intervention name(s): Resistance Exercise; Flexibility Training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 60 minute sessions 3 times a week of moderate-vigorous lower and upper body free-weight strength training plus impact training (jumps). Two of the three sessions are conducted in a supervised setting at a university fitness facility and the third session is a modified version of the exercise program performed at home. Participants are in the exercise program for 12 months; 60 minute session 3 times a week focusing on whole body flexibility (stretching) and relaxation (progressive neuromuscular relaxation, focused breathing) exercises. Exercises are selected to be non-weight bearing and require minimal muscle strength in order to provide a contrast to the intervention arm. Two sessions are conducted in a supervised setting at a university fitness center and the third is a home-based version of the program performed at home.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: randomized clinical trial; elderly; cancer survivor; bone health; body composition; signs and symptoms
Clemastine in Cardiovascular Surgery
Condition: Efficacy and Safety
Study type: Interventional

Summary: 
      In this study, a prospective, randomized, double-blind pilot trial designed to evaluate the
      effect of histamine H1 receptor antagonist clemastine on perioperative anaphylaxis in
      cardiovascular surgery with cardiopulmonary bypass, especially for the efficacy and safety on
      reducing heparin and protamine associated anaphylaxis.
    

Detailed description: 
      In this study, a prospective, randomized, double-blind pilot trial designed to evaluate the
      effect of histamine H1 receptor antagonist clemastine on perioperative anaphylaxis in
      cardiovascular surgery with cardiopulmonary bypass, especially for the efficacy and safety on
      reducing heparin and protamine associated anaphylaxis.
    

Intervention name(s): Clemastine; Saline Solution
Intervention type(s): Drug; Drug
Intervention description(s): Clemastine fumarate 2mg/2ml intramuscular injection is administrated into the gluteus maximus muscle; Saline solution 2ml intramuscular injection is administrated into the gluteus maximus muscle
Intervention MeSH terms: Clemastine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Cardiovascular Surgery; Histamine H1 Receptor Antagonist; Anaphylaxis
Drug-Drug Interaction Study to Assess the Effects of Multiple-Dose Administration of K-877 on the Pharmacodynamics and the Pharmacokinetics of Multiple-Dose Administration of Warfarin in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of K-877 on the pharmacodynamics and the
      pharmacokinetics of warfarin in healthy adults volunteers.
    


Intervention name(s): Warfarin; K-877
Intervention type(s): Drug; Drug
Intervention MeSH terms: Warfarin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Biomarker Assay Validation in Healthy Smokers and COPD Smokers and Ex-smokers
Condition: COPD; Asthma
Study type: Observational

Summary: 
      This study will collect sputum samples from healthy smokers, COPD smokers and COPD ex-smokers
      to analyse biomarkers of inflammation
    


Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Up to 20 of each of the following populations will be recruited in this study:

          -  Healthy smoking subjects

          -  Smoking subjects with COPD

          -  Ex-smoking subjects with COPD
      
Biospecimen description: 
      Sputum