bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of ABT-384 in Subjects With Mild-to-Moderate Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to test if the investigational medication, ABT-384, is a safe
      and effective treatment for adults with mild-to-moderate Alzheimer's Disease.
    

Detailed description: 
      This is a Phase 2 study designed to evaluate the safety and efficacy of ABT-384 in
      approximately 260 adults with mild-to-moderate Alzheimer's Disease (AD). Subjects will be
      randomized to one of four treatment groups (ABT-384, donepezil, or placebo) for a 12-week
      Treatment Period.
    

Intervention name(s): ABT-384; donepezil; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will take study drug once daily for 12 weeks; Subjects will take study drug once daily for 12 weeks.; Subjects will take study drug once daily for 12 weeks
Other intervention name(s): Aricept
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Antihypertensive Efficacy and Tolerability and Determine the Adequate Antihypertensive Dosage of Fimasartan in Mild to Moderate Essential Hypertension Patients
Condition: Hypertension
MeSH terms: Hypertension; Essential Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the antihypertensive efficacy and tolerability of 8
      week treatment with Fimasartan (BR-A-657-K) 20, 60, 120, 240 mg and placebo in patients with
      mild to moderate essential hypertension and to determine the adequate antihypertensive dosage
      for later clinical study.
    

Detailed description: 
      Fimasartan (BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and
      potent antihypertensive effect in many hypertensive models. Phase I study, Fimasartan
      (BR-A-657-K) 20mg ~ 480mg single dosing with healthy subjects, demonstrated that the
      Fimasartan (BR-A-657-K) was very safe and well tolerated. Another phase I study, Fimasartan
      (BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that Fimasartan (BR-A-657-K) was
      safe and tolerable though one temporal adverse event was observed in high dose.

      A randomized, double-blind, placebo-controlled, parallel grouped, clinical study will be
      conducted to evaluate the antihypertensive efficacy and tolerability and to determine
      adequate antihypertensive dosage of Fimasartan(BR-A-657-K) in patients with mild to moderate
      essential hypertension.

      Approximately 182 patients will be enrolled over 12 months in 8 centers nationwide.

      After 2 weeks of placebo run-in period, all subjects will be randomized into one of the
      following 5 groups. Subjects will take test/control drug for 8 weeks of treatment period. If
      subjects take any antihypertensive medications before screening, the subjects will have 1
      week of wash-out period.

      Group I : Placebo, Group II : Fimasartan 20 mg, Group III: Fimasartan 60 mg, Group IV :
      Fimasartan 120 mg, Group V : Fimasartan 240 mg,
    

Intervention name(s): Fimasartan
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypertension; Fimasartan
Lipofilling as a Treatment for Vestibulodynia
Condition: Vestibulodynia
MeSH terms: Vulvodynia; Vulvar Vestibulitis
Study type: Interventional

Summary: 
      The investigators would like to investigate if lipofilling with its adipose derived stem
      cells (ADSC) could be a new, less invasive but equally or more effective therapeutic option
      for women with vestibulodynia than vestibulectomy. The investigators expect the study to be
      successful because of the anti-inflammatory effects of the ADSC and its effectiveness
      -although not thoroughly studied- in some neuropathic pain disorder like pudendal neuralgia
      or post mastectomy pain syndrome.

      Method: A controlled intervention study: one group receiving golden standard therapy
      'vestibulectomy' and one group receiving vestibular lipofilling.
    


Intervention name(s): Adipose derived stem cell transplantation via lipofilling; Surgical excision
Intervention type(s): Procedure; Procedure
Intervention description(s): Liposuction of 60cc abdominal fat with its adipose derived stem cells which will be reinjected (10-20 cc) in the vestibular area after centrifugation for 3 minutes at 1000 rpm and decantation of oil and red blood cells.; Excision of painful areas
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: However, subjects in the lipofilling group will be able to undergo surgery (excision) 3 months after the lipofilling of this intervention did not have the requested effect.
Masking: None (Open Label)
Primary purpose: Treatment
Eflornithine and Sulindac in Preventing Colorectal Cancer in Patients With Colon Polyps
Condition: Precancerous Condition
MeSH terms: Precancerous Conditions
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized phase III trial is studying eflornithine and sulindac to see how well they
      work compared to a placebo in preventing colorectal cancer in patients with colon polyps.
      Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming
      back. The use of eflornithine and sulindac may prevent colorectal cancer. It is not yet known
      whether eflornithine and sulindac are more effective than a placebo in preventing colorectal
      cancer
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Compare the rate of new adenomatous polyp formation in patients with a history of
      adenomatous polyps of the colon treated with eflornithine and sulindac vs placebo.

      II. Correlate the effects of eflornithine and sulindac on polyamine and prostaglandin content
      in the flat mucosa with the rate of new adenoma formation in these patients.

      III. Compare the rate of side effects in patients treated with these regimens.

      OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients
      are stratified according to participating center and aspirin use (yes vs no).

      Patients receive oral double placebo once daily for 4 weeks. Patients who are more than 70%
      compliant by pill measurement or self reporting are randomized to 1 of 2 treatment arms.

      Arm I: Patients receive oral double placebo once daily.

      Arm II: Patients receive oral eflornithine (DFMO) and oral sulindac once daily.

      In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or
      the development of an invasive malignancy.
    

Intervention name(s): placebo; eflornithine; sulindac; laboratory biomarker analysis
Intervention type(s): Other; Drug; Drug; Other
Intervention description(s): Given orally; Given orally; Given orally; Correlative studies
Other intervention name(s): PLCB; 2-difluoromethylornithine; DFMO; difluromethylornithine; Aflodac; Algocetil; Clinoril; SULIN
Intervention MeSH terms: Eflornithine; Sulindac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Lot-to-lot Consistency of Sci-B-Vac™ in Adults
Condition: Hepatitis B Vaccines
MeSH terms: Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      A Controlled Trial to Assess the Lot-to-lot Consistency of Sci-B-Vac™ in Adults
    

Detailed description: 
      The primary objective of the study is to verify that the manufacturing equivalence of
      Sci-B-Vac™ is consistent and to compare the immunogenicity and safety of a three-dose regimen
      of Sci-B-Vac™ to a three-dose regimen of Engerix-B® in adults.
    

Intervention name(s): Hepatitis B Vaccination
Intervention type(s): Biological
Intervention description(s): Hepatitis B Vaccination
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind Randomized Controlled Trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Hepatitis B Vaccines
Quality of Life Impact of Chronic Rhinitis Treatment With Aerin Medical Device
Condition: Chronic Rhinitis
MeSH terms: Rhinitis
Study type: Observational

Summary: 
      Evaluation of long-term (2-year) quality of life and symptoms after chronic rhinitis
      treatment with the Aerin InSeca/RhinAer Stylus
    

Detailed description: 
      This is a prospective, non-randomized, multicenter follow-up study to collect long-term data
      on a cohort of patients who participated in the Aerin Medical TP668 study, "Clinical
      Evaluation of Low Power Radiofrequency Energy Applied to the Posterior Nasal Nerve Area for
      Symptomatic Relief of Chronic Rhinitis". The study will be conducted in a maximum of 5
      centers that participated and enrolled patients in the TP668 study.
    

Intervention name(s): Radiofrequency Stylus
Intervention type(s): Device
Intervention description(s): Low power radiofrequency energy delivered to the posterior nasal nerve area
Other intervention name(s): Aerin Medical Device; InSeca Stylus; RhinAer Stylus
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who completed the 52-week follow-up visit of Aerin Study TP668 and consent to
        provide long-term quality of life and symptom information.
      
Keywords: Chronic rhinitis; Posterior nasal nerve; Quality of life
Two Center Study to Determine Effect of G17DT on Plasma Gastrin Levels in Patients With Colorectal Cancer.
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Pancreatic, gastric, and colorectal cancers have all been shown to overexpress the gastrin
      gene and to be sensitive to the trophic effects of the gastrin in animal models. The
      hypothesis of this study is that G17DT will elicit specific and high-affinity antibodies that
      will bind gastrin-17, thus preventing the trophic activity of cancer cells.
    


Intervention name(s): G17DT; Placebo Comparator
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Communication in ICU During COVID-19
Condition: COVID-19; Severe Acute Respiratory Syndrome Coronavirus 2; Severe Acute Respiratory Syndrome
MeSH terms: COVID-19; Severe Acute Respiratory Syndrome; Syndrome
Study type: Observational

Summary: 
      This study explores the actual situation of communication during the Coronavirus disease 2019
      (COVID-19) pandemic in the South Asia and Middle East region. The purpose is to assess the
      effect of the limited visitor policy during the COVID-19 pandemic, on the pattern of
      interaction of critically ill patients to their kin/ guardian and doctor-family members
      communication.

      Primary objective of this study are as follows:

        1. Explore the changes in communication pattern with limited contact during the COVID-19
           pandemic.

        2. Assess the methods of informed consent in Intensive care units (ICUs) during the same
           period
    

Detailed description: 
      An observational, cross-sectional, web-based questionnaire survey, with multi-centre
      involvement across hospitals in the South Asia and middle-east region. The questionnaire
      consists of two sections. Section one obtains information from participants regarding
      communication and visiting practices in ICU during pre-COVID-19 era, and the Section two
      obtains information regarding the policy changes if any during the COVID-19 pandemic in
      regards to safety of healthcare workers (HCWs) and public.

      In order to obtain the largest representation of South Asia and Middle East ICUs, a network
      of research doctors as facilitators from each country is created. The role of the
      facilitators is to contact and recruit adult ICUs within their country. Each facilitator
      contacts the hospitals (public and private), creating a network of collaborating
      doctors/nurses (participants) from those hospitals who expressed their willingness to
      participate.

      Data collection: a web based Google Forms with online access will be used Only one entry per
      ICU will be collected during the study. Statistic analysis: a descriptive analysis is planned
      for the general characteristics of the participating units and the study population.
    

Intervention name(s): Communication
Intervention type(s): Behavioral
Intervention description(s): policies on communication and informed consent in ICU
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        ICU communication teams across South Asian and Middle East Region
      
Keywords: Communication in ICU; Doctor-family members communication; Informed consent
Dynamic Optical Coherence Tomography(D-OCT) Aging Study: A Preliminary Evaluation of Structural Differences Between Young and Aged Skin, Cellulite and Atrophic Acne Scars in Female Caucasian Subjects With Fitzpatrick Skin Types I-III Utilizing Non-invasive in Vivo D-OCT.
Condition: Skin Care
MeSH terms: Cellulite
Study type: Observational

Summary: 
      This single-center clinical study is being conducted over the course of 2 weeks to conduct an
      exploratory pilot study as a preliminary evaluation of D-OCT's ability to measure skin
      changes from aging. Assess structural differences between young and aged skin on the face. To
      identify the structural characteristics of atrophic acne scars relative to normal skin on the
      face. To explore characteristics of cellulite relative to normal skin on the thigh in young
      and aged skin.
    


Intervention name(s): Skin Imaging; Facial Cleanser
Intervention type(s): Device; Other
Intervention description(s): Non-invasive in vivo skin imaging will be taken with the VivoSight D-OCT and the measurements will be acquired post-study utilizing VivoSight software.; Participants will be instructed to remove all makeup from the face and cleanse the face with SkinMedica Facial Cleanser at least 15 minutes prior to investigator assessments and photography, and at least 30 minutes prior to use of D-OCT. Particiapnts in the cellulite group will have the thigh area cleansed with Facial Cleanser at least 15 minutes prior to photography and at least 30 minutes prior to use of D-OCT. For standardization, this procedure will be performed with SkinMedica Facial Cleanser (to remove makeup and cleanse the face and thigh (if applicable)) for all the participants.
Other intervention name(s): SkinMedica® Facial Cleanser
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Female Caucasian subjects with Fitzpatrick skin types I-III that meet one of the criteria
        listed; ages 18-30 years old without acne scars on the face with or without visible
        cellulite on posterior thigh, or ages 55-75 years old without acne scars on the face with
        or without visible cellulite on posterior thigh, or ages 18-75 years old with atrophic acne
        scars.
Weekly Paclitaxel Plus Carboplatin in Preoperative Treatment of Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the pathological complete response (pCR) rate in
      breast cancer patients treated with weekly paclitaxel plus carboplatin preoperative regimen.
    

Detailed description: 
      Breast cancer is the leading cause of cancer in women in China. Preoperative chemotherapy for
      treatment of locally advanced breast cancer has become a standard therapy. Results from
      neoadjuvant trials have shown that pathological complete response (pCR) is an independent
      predictor of outcome. Paclitaxel was introduced into clinical practice in the early 1990s and
      has demonstrated good activity in the adjuvant and metastatic settings. Platinum complexes,
      like cisplatin and carboplatin, are active in a wide range of solid tumors. Paclitaxel
      combined with carboplatin has shown great activity in ovarian and nonsmall- cell lung cancer
      treatment. In addition, the overall response rate of paclitaxel plus carboplatin was between
      53% and 62% in the first-line treatment of metastatic breast cancer. This study will evaluate
      the pCR rate of weekly paclitaxel plus carboplatin as preoperative treatment for breast
      cancer patients.
    

Intervention name(s): Paclitaxel, Carboplatin
Intervention type(s): Drug
Intervention description(s): Paclitaxel 80 mg/m2, carboplatin AUC of 2 mg/min/ml, given on days 1, 8 and 15 of a 28-day cycle.
Intervention MeSH terms: Paclitaxel; Carboplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Neoplasms; Neoadjuvant; Chemotherapy; Paclitaxel; Carboplatin; Pathological Complete Remission
A Study Assessing the Drug Levels, Drug Effects, and Safety of BMS-986322 in Healthy Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      A Study assessing the drug levels and drug effects of variable doses of BMS-986322 in Healthy
      Participants compared to a placebo. The study also assesses how BMS-986322 affects the body
      with food and its acidity levels.
    

Detailed description: 
      Recruitment temporarily on hold due to COVID-19.

      This is a randomized, double-blind, placebo-controlled study which will investigate the
      safety, tolerability, and PK of single and multiple oral doses of BMS-986322 in healthy
      subjects. The trial consists of three parts: Part A - a single ascending dose (SAD) safety
      and pharmacokinetic (PK) evaluation; Part B -a multiple ascending dose (MAD) safety, PK, and
      pharmacodynamic (PD) evaluation; and Part C - effect of food and pH on PK and safety.
    

Intervention name(s): BMS-986322; BMS-986322 Placebo; famotidine
Intervention type(s): Drug; Other; Drug
Intervention description(s): Specified Dose on Specified Days; Specified Dose on Specified Days; Specified Dose on Specified Days
Intervention MeSH terms: Famotidine
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Sertraline for Alcohol Dependence and Depression
Condition: Alcoholism; Depression
MeSH terms: Alcoholism; Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will examine depressed alcoholic outpatients to assess whether combining
      naltrexone (Revia) and sertraline (Zoloft) will result in greater reductions in both drinking
      and depression over either medication alone or placebo. A secondary aim is to determine
      whether certain patient features will predict response to sertraline, naltrexone or the
      combination of the two drugs. Subjects will be randomized into treatment groups for 14 weeks.
      The followup phase includes two visits at 6 and 9 months after treatment.
    

Detailed description: 
      The proposed study will examine managing relapse in patients with alcohol dependence and
      depression using a 14-week double-blind, placebo-controlled, combination of 100 mg/day of
      naltrexone, 200 mg/day of sertraline, and individual, cognitive behavioral therapy (CBT). For
      testing the medication, the design will be 2x2, consisting of four groups:
      naltrexone/sertraline, naltrexone only, sertraline only, placebo. All four groups will
      receive once weekly sessions of CBT given by therapists experienced in working with patients
      with substance disorders and trained in the principles of CBT.
    

Intervention name(s): naltrexone (Revia); sertraline (Zoloft); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100mg/day; 200mg/day; Placebo
Intervention MeSH terms: Naltrexone; Sertraline
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Left Lateral Tilt-down Position During Colonoscopy Insertion
Condition: Colonoscopy Insertion
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the left lateral tilt-down position, which
      includes procedures that involve placing patients on their left lateral side at an angle to
      make their heads lower than their feet, is more beneficial than the left lateral horizontal
      body position (patient horizontally laying on their left side, traditionally used for
      colonoscopies) to decrease descending colon insertion time, the difficulty of colonoscopy
      procedure and patients' pain.
    

Detailed description: 
      Supine with tilt-down position (trendelenburg position) is used in abdominal and
      gynecological surgery to allow better access to the pelvic organs, as gravity pulls the bowel
      out of the pelvic cavity and the rectosigmoid angle straightens, which may also be favorable
      for colonoscopy insertion. However, few published studies have explored the value of
      tilt-down position in the colonoscopy (left lateral horizontal body position are usually
      used) and there is consequently little evidence to support left lateral tilt-down position or
      left lateral horizontal body position. So the investigators perform a randomized controlled
      trial of left lateral tilt-down position versus left lateral horizontal position for
      colonoscopy to investigate the safety and efficacy of lateral tilt-down position.
    

Intervention name(s): left lateral tilt-down position; left lateral horizontal position
Intervention type(s): Procedure; Procedure
Intervention description(s): patients will be positioned on their left side and at an angle of 20 degree; patients will be horizontally positioned on their left side
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: colonoscopy insertion; tilt-down position