bioihbjkbjnl/mcl2 huggingface dataset:
Women's Healthy Eating and Living Study
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Dietary fats, fruits, vegetables, and fiber may affect the risk of breast cancer
      recurrence.

      PURPOSE: Randomized clinical trial to determine the effectiveness of a diet rich in
      vegetables, fruit, and fiber and low in fat in women who have been treated for stage I, stage
      II, or stage III breast cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine whether a diet rich in vegetables, fruit, and fiber and low in fat
      is associated with a longer breast cancer event-free interval in breast cancer survivors. II.
      Motivate an intervention group of breast cancer survivors to adopt and maintain a dietary
      pattern that is rich in vegetables, fruit, and fiber and low in fat. III. Demonstrate that
      the intervention can produce significant changes in circulating carotenoid and estrogen
      biomarkers compared to a healthy control diet. IV. Test whether the probability of a
      secondary cancer event is associated with change in self-reported dietary intake, circulating
      carotenoid concentrations, and circulating estrogen concentrations.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age
      (under 55 vs 55 and over at time of diagnosis), stage of tumor (stage I and at least 1 cm vs
      stage II/IIIA), and clinical site. Patients are randomized to one of two healthy dietary
      regimens: Arm I: Patients are taught to follow a dietary pattern that will produce
      significant changes in circulating carotenoid and estrogen biomarkers. Arm II: Patients are
      assigned to follow dietary guidelines established by the National Cancer Institute and the
      USDA. All patients participate in 24 hour dietary recalls, cooking classes, as well as
      complete several questionnaires, at baseline and then at 12, 24 or 36, 48, and 72 months; a
      randomly selected 50% sample participate in recall at 6 months. Patients are followed by
      telephone every 6 months for an average of 6 years.

      PROJECTED ACCRUAL: A total of 3,000 women will be accrued for this study within 5 years.
    

Intervention name(s): educational/counseling intervention; therapeutic dietary intervention
Intervention type(s): Behavioral; Behavioral
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women who were diagnosed with early-stage breast cancer within the previous 4 years, and
        are between the ages of 18-74
      
Biospecimen description: 
      Serum, plasma, buffy coat, RBC, DNA at five time periods
    
Keywords: stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; recurrent breast cancer
Activity and Safety of Oral Administration of SSR150106XB for the Reduction of Inflammation in Patients With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to assess the reduction of systemic inflammation as
      measured by serum levels of C-reactive protein (CRP).

      The secondary objectives are:

        -  to assess the reduction of systemic inflammation as measured changes in acute phase
           protein, serum amyloid A (SAA) and cytokine interleukin-6 (IL-6), and clinical American
           College of Rheumatology response rate, and morning stiffness duration;

        -  to assess the effect on pain relief within first 14 days;

        -  to obtain evidence of the safety and tolerability of SSR150106;

        -  to document trough plasma levels of SSR150106 and its first metabolite.
    


Intervention name(s): SSR150106; Placebos
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Inflammation; anti-cytokine; anti-chemokine
Safety and Immunogenicity of AERAS-402 in HIV-infected, Bacillus Calmette-Guerin (BCG)-Vaccinated Adults
Condition: Tuberculosis; HIV Infections
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a Phase II, randomized, double-blind, placebo-controlled trial conducted at 1 site
      in South Africa. A total of 26 subjects were randomized 1:1 to receive 2 doses of either
      AERAS-402 at 3 x 10^10 vp (N=13) or placebo (N=13) on Study Days 0 and 28. Dose-escalation to
      a second group of 40 subjects was planned, but although no safety concerns were identified,
      the sponsor decided not to continue the study.
    

Detailed description: 
      Further study details as provided by Aeras.
    

Intervention name(s): AERAS-402; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.; Placebo was the identical buffer solution in which AERAS-402 is formulated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV; Tuberculosis; Vaccine
Study to Evaluate Safety, Tolerability, Pharmacokinetics and the Food Effect on PK of ASC10 Tablets in Healthy Subjects
Condition: SARS CoV 2 Infection
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, randomized, double-blind, placebo-controlled study to evaluate safety,
      tolerability, and pharmacokinetics of ASC10 tablets and an open-label, crossover design to
      evaluate the food effect on PK of ASC10 in healthy subjects
    


Intervention name(s): ASC10; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Part 1:
Participants will be randomized to receive twice daily dosing either ASC10 or Placebo for 5.5 days, in an double-blind manner
Part 2:
Two single oral doses of ASC10 will be administered to participants, in an open-label manner; Part 1:
Participants will be randomized to receive twice daily dosing either ASC10 or Placebo, in an double-blind manner
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ASC10; RdRp; Healthy
Evaluation of Effect of Vonoprazan on Midazolam Pharmacokinetics in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the time-dependent inhibition potential of repeated doses of oral vonoprazan on
      the pharmacokinetics (PK) of a single oral dose of midazolam, a sensitive cytochrome P450 3A4
      (CYP3A4) substrate, in healthy participants.
    

Detailed description: 
      This clinical trial information was submitted voluntarily under the applicable law and,
      therefore, certain submission deadlines may not apply. (That is, clinical trial information
      for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public
      Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by
      sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
    

Intervention name(s): Vonoprazan; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg tablets administered orally; 2 mg syrup administered orally
Intervention MeSH terms: Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: vonoprazan; midazolam
Safety and Efficacy of Adipose Derived Stem Cells for Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This will be an open-label, non-randomized multi-center study designed to assess the safety
      and efficacy of Adipose-derived Stem Cell (ASC) IV implantation. The therapy is composed of
      cells isolated from a patient's own adipose tissue. Liposuction will be performed to collect
      the adipose tissue specimen for subsequent processing to isolate the stem cells.
    

Detailed description: 
      In the context of the proposed study, adipose derived stem cells (ASC) constitute an
      autologous cell product that is delivered to the patient via intra-venous injection. In this
      study, we propose to investigate the immunosuppressive potential of the non-manipulated
      non-cultured stromal vascular fraction obtained via liposuction. Endpoints will be measured
      both by improvement of the forced evacuation volume in one second (FEV1) and distance covered
      in a 6 minute walk distance test (6MWD). The stromal vascular fraction comprises stromal
      cells isolated from total fat via enzymatic digestion ex-vivo. These cells are not cultured
      but are isolated from adipose tissue using a sterile tissue process in under two hours. The
      process includes rinsing in a saline solution to remove red blood cells, draining, and
      enzymatic digestion (collagenase) which isolates endothelial cells from adipose tissue.
      Post-processing, the pellet obtained via centrifugation is filtered and delivered to the
      patient who remains sedated within the same ambulatory center.
    

Intervention name(s): Adipose Derived Stem Cell (ADSC) Therapy
Intervention type(s): Drug
Intervention description(s): Patients undergo a liposuction where 100 cc of fat are extracted. The ADSCs are then isolated and injected intravenously.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD
Evaluating Therapeutic Massage for Chronic Neck Pain
Condition: Neck Pain; Cervicalgia
MeSH terms: Neck Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will provide the basis for a full-scale trial to evaluate the effectiveness and
      safety of therapeutic massage for chronic neck pain (CNP).
    

Detailed description: 
      Neck pain is one of the most common problems affecting the health of Americans and is a
      leading reason for using complementary or alternative medical (CAM) therapies. Therapeutic
      massage is one of the most popular CAM treatments for neck pain, but little is known about
      its effectiveness. This study will lay the groundwork for a full-scale trial that evaluates
      the effectiveness of therapeutic massage for chronic neck pain.

      The study will involve two phases. During Phase I, researchers will develop and pre-test key
      components for a randomized clinical trial. In Phase II, the safety and efficacy of massage
      for CNP will be evaluated. The changes in symptoms, function, and quality of life in massage
      and self care groups will be evaluated midway through treatment, at the end of treatment and
      at 6 months post randomization.
    

Intervention name(s): massage
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: neck pain; cervicalgia; massage
A Single-dose Study to Investigate the Tolerance and Pharmacokinetics of Finamine Tablets in China
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Design：Randomization, double-blind, single-center, single-dose, dose-escalation , placebo and
      parallel control Objectives：

        1. To investigate the tolerability and safety of Chinese healthy adult subjects after a
           single oral administration of Finamine tablets;

        2. To investigate the pharmacokinetic (PK) characteristics of Finamine tablets;

        3. To provide dose setting basis for follow-up clinical studies. Investigational
           subject:Healthy-adult subjects in China

      34 cases (including 4 cases of the pre- trial), of which the 150mg dose group is in the 4
      cases of pre- trial (open, all accepted Finamine tablets orally, among whom, two receive it
      under fasting condition , and the other two receive it half an hour post a high-fat meal
      started). There are 6 cases in the formal trial (the subjects' ratio of investigational drug
      to placebo is 2:1). In all other dose groups, the subjects' ratio of investigational drug to
      placebo is 3:1.
    


Intervention name(s): Finamine tablets; Placebo tablets
Intervention type(s): Drug; Drug
Intervention description(s): taken Finamine tablets orally; taken Placebo tablets orally
Other intervention name(s): Finamine tablet
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
A Trial of the Effect of CVL-865 on Panic Symptoms Induced by Carbon Dioxide Inhalation in Healthy Subjects
Condition: Panic Disorder
MeSH terms: Panic Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine anxiolytic effect of multiple doses of CVL-865
      using an experimental medicine model of carbon dioxide (CO2) inhalation in healthy
      volunteers.
    


Intervention name(s): CVL-865 High dose; Alprazolam 1mg XR; Placebo; CVL-865 low dose
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): High dose CVL-865: Will be administered as 5mg BID for 2 days followed by 12.5mg BID for another 2 days during the Titration Phase. 25mg will be administered during the Maintenance Phase (3 days of BID and morning dose only on the 4th day); Alprazolam 1mg XR will be administered for 8 days BID (morning dose only on 8th day); Placebo, oral tablet/capsule will be administered for 8 days BID (morning dose only on 8th day); Low dose CVL-865, oral tablets. Will be administered as 2.5mg BID for 2 days followed by 5mg BID for another 2 days during the Titration Phase. 7.5mg BID will be administered during the Maintenance Phase (3 days of BID and morning dose only on 4th day)
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anxiety; Panic; CVL-865; PF-06372865; Hypercapnia; CO2 challenge; Healthy Subjects
Clinical and Histological Evaluation of BTL-785F Device for Non-invasive Treatment of Face
Condition: Wrinkle
Study type: Interventional

Summary: 
      This study will evaluate the clinical efficacy, safety and the performance of the BTL-785-7
      applicator of the BTL-785F system for non-invasive treatment of facial wrinkles and overall
      improvement of facial appearance.
    

Detailed description: 
      The changes in the skin related to the connective tissue structural proteins (i. e. elastin
      and collagen fibers) will be assessed histologically. The study is a prospective,
      single-center, two-arm, open-label study. The subjects will be enrolled and assigned into two
      groups; Group A (RF & EMF) and Control group, which will not receive any treatment.

      At the baseline visit, health status will be assessed. Inclusion and exclusion criteria will
      be verified and informed consent will be signed. Punch biopsies of the facial skin
      (preauricular area) for the examination of changes related to skin's connective tissue, and
      photographs of the treated area will be taken.

      The treatment administration phase in the treatment group will consist of four (4) treatment
      visits, delivered 5-10 days apart.
    

Intervention name(s): BTL-785-7
Intervention type(s): Device
Intervention description(s): Treatment with BTL-785F device (BTL-785-7 applicator) for non-invasive facial rejuvenation.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
AMelioration of Angiotensin Converting Enzyme Inhibitor Induced Angioedema Study
Condition: Angioedema
MeSH terms: Angioedema
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter study recruiting patients with angioedema induced by ACEI.

      Open-label treatment with subcutaneous Icatibant compared to a historic group of 47 patients
      with ACE inhibitor induced angioedema which the investigators have been previously treated in
      the investigators centers with current "standard" therapy (250 mg methylprednisolon and 2 mg
      clemastine).

      In cases with fast progression of edema after application the study-drug, a second
      application with icatibant could be necessary. Rescue medication and intervention.
    

Detailed description: 
      Sudden occurrence of subcutaneous or submucosal non-itchy swelling, so-called angioedema, is
      a well known side effect of angiotensin-converting enzyme inhibitors (ACEi), which may become
      life-threatening if the upper airway is involved. To be note, ACEi induced angioedema were
      always located in the head and neck region.

      The pathophysiology of ACE inhibitor (ACEi) induced angioedema most likely resembles that of
      hereditary angioedema (HAE), i.e. it is mainly mediated by bradykinin induced activation of
      vascular bradykinin B2 receptors (BKR-2). In contrast to an increased bradykinin generation
      in HAE, treatment with ACEi decreases the bradykinin degradation in plasma and increases the
      biological activity of bradykinin.

      The current pharmacotherapy of ACEi induced angioedema is not satisfactory. Antihistamines
      and corticosteroids may be effective in the treatment of urticaria with cutaneous edema and
      itchy, but are theoretically ineffective and hence superfluous in bradykinin induced
      angioedema. However, glucocorticoids still belong to the standard treatment of angioedema.

      We hypothesized that the BKR-2 antagonist icatibant might be an effective therapy for
      ACEi-induced angioedema.

      Patients with ACEi induced angioedema, located in the upper aero-digestive tract will be
      randomized and treated either with icatibant and plazebo or cortisone with clemastin and
      plazebo.
    

Intervention name(s): Icatibant (subcutaneous) and plazebo (intravenous); Cortisone + Clemastin (intravenous) and plazebo (subcutaneous)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cortisone; Icatibant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ACE inhibitor induced angioedema; Bradykinin; Non-itching edema; Non-allergic angioedema; Quincke edema; Drug induced angioedema; Bradykinin B2 receptor antagonist; Icatibant; HOE 140
Effect of Chlorhexidine-Induced Oral Care on Ventilator-Related Some Respiratory System Complications
Condition: Ventilator Associated Pneumonia; Tracheobronchitis
MeSH terms: Pneumonia, Ventilator-Associated
Study type: Interventional

Summary: 
      Ventilator-associated pneumonia and ventilator-associated treakeabronchitis in respiratory
      tract infections associated with ventilator are common infections in intensive care unit and
      cause significant morbidity, mortality and health expenditures in nosocomial infections.
      Adequate and effective oral care by nurses in intensive care patients, possible
      complications, intensive care unit stay in the intensive care unit and is very important in
      terms of mortality.
    

Detailed description: 
      The aim of this study will (1) evaluate the effect of 0.12% chlorhexidine gluconate on
      ventilator-associated pneumonia, ventilator-associated treakeabronchitis, (2) determine the
      effect of preventing microorganism colonization, and (3) assess the mortality rate for each
      patient and the cost-effectiveness in the health expenditures.
    

Intervention name(s): 0.12% chlorhexidine gluconate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The patients included in the experimental group (0.12% chlorhexidine gluconate) will receive 3 times daily oral care; The patients included in the placebo group ( sodium bicarbonate) will receive 3 times daily oral care
Other intervention name(s): sodium bicarbonate
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Effects of Propofol-dexmedetomidine on Immune Function in Patients With Cancer Larynx
Condition: Cancer Larynx; Total Laryngectomy
Study type: Interventional

Summary: 
      The aim of this prospective, randomized clinical study is to compare between propofol and
      isoflurane on perioperative immune cell populations and function in patients undergoing total
      laryngectomy surgery.
    

Detailed description: 
      The perioperative period might be a critical time in primary cancer surgery because many
      factors can affect whether recurrence, or metastasis , or elimination by the immune system.

      Cancer surgery can induce an acute inflammatory response, due to local tissue damage and the
      shedding of malignant cells into the blood and lymphocytic circulation although meticulous
      surgical manipulation. Many evidences suggest that several factors during the perioperative
      period can affect the immune system.

      These could be attributed to the surgery per se, pain, anxiety, hypothermia, blood
      transfusion, anesthetic technique, and anesthetic drugs .Impairment in the immune system may
      allow malignant cells to escape immuno-surveillance and metastasize in the perioperative
      period.As well as increase the risk of postoperative complications, such as systemic
      inflammatory response syndrome, sepsis, and multi-organ failure.

      Previous retrospective clinical studies of both breast and prostate cancer surgery have
      suggested an association between anaesthetic technique and cancer recurrence.

      However ,other retrospective trials on various forms of cancer have shown no such benefit.
    

Intervention name(s): Propofol group; Isoflurane group
Intervention type(s): Drug; Drug
Intervention description(s): Anesthesia is maintained with continuous infusion of propofol 1.5-2mg/kg/h and dexmedetomidine 0.2-1ug/kg/h.; Anesthesia was maintained with isoflurane at a concentration of 2-2.5%. fentanyl 50 ug increments
Intervention MeSH terms: Propofol; Isoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
A Study to Evaluate Methodologies for Measuring Swelling of the Leg and Ankle (MK-0000-106)(COMPLETED)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate methodologies for measuring pedal edema associated with calcium
      channel blockers in middle-aged and elderly subjects and patients with hypertension.
    


Intervention name(s): Comparator: amlodipine besylate; Comparator: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Two 5 mg tablets amlodipine daily for 6 weeks.; Two 5 mg tablets placebo to amlodipine daily for 6 weeks
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic