bioihbjkbjnl/mcl2 huggingface dataset:
Recombinant Human Serum Albumin in Patients With Liver Cirrhosis and Ascites Subjects
Condition: Hepatic Ascites
MeSH terms: Ascites
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial adopts a randomized, double-blind, positive drug-controlled, dose-escalated phase
      Ib clinical study evaluating the safety, tolerability, pharmacokinetic characteristics and
      preliminary effectiveness of recombinant human serum albumin in patients with liver cirrhosis
      and ascites

      subjects (both male and female) were screened and enrolled to the three dose levels of 10g,
      20 g,and 30 g according to the principle of dose escalation, and 8 out of 12 subjects in each
      dose group One patient received the test drug, and 4 received a positive drug.
    

Detailed description: 
      In this Phase Ib clinical trial, randomized, double-blind, positive-controlled,
      dose-increasing design was employed to enroll cirrhosis ascites patients and evaluate safety,
      tolerability, PK characteristics, PD characteristics and preliminary efficacy at different
      dose levels of recombinant human serum albumin.

      Three dose groups (10 g/day, 20 g/day, 30 g/day) were set up in this study, and they were
      escalated from the lowest to the highest dosage. It is planned to enroll 12 subjects in each
      dose group, with 8 of 12 subjects in each dose group receiving the investigational product
      and 4 of 12 subjects receiving the comparator product intravenously once a day for 14 days or
      up to serum albumin ≥ 35 g/L ( whichever occurs first ), to investigate the safety,
      tolerability, immunogenicity, PK characteristics, PD characteristics and preliminary efficacy
      in repeated usage of recombinant human serum albumin.
    

Intervention name(s): Recombinant Human Serum Albumin; Human serum albumin
Intervention type(s): Drug; Drug
Intervention description(s): 10 g/bottle (20%, 50 mL); 10 g/bottle (20%, 50 mL)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Promoting Resiliency Among Lymphoma Survivors: The 3RP-Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional

Summary: 
      The Relaxation Response Resiliency Program (3RP) was developed by researchers at the MGH
      Benson-Henry Institute for Mind Body Medicine; This program has recently been adapted to
      target the needs of individuals who have completed treatment for lymphoma (3RP-Lymphoma).
    

Detailed description: 
      The Relaxation Response Resiliency Program, or 3RP, was developed by researchers at the MGH
      Benson-Henry Institute for Mind Body Medicine. The 3RP is a group program that-through a
      variety of mind-body approaches, such as imagery, relaxation, and yoga-seeks to buffer stress
      and promote psychological resiliency and physical well-being.

      The 3RP has not yet been carried out with individuals who have recently completed treatment
      for lymphoma. As such, the investigators have adapted the standard 3RP program to target the
      specific needs of lymphoma patients who are transitioning off active treatment. The
      investigators are conducting this study to see if the adapted program, the 3RP-Lymphoma, is
      effective at reducing stress and stress-related symptoms for people who have completed
      treatment for lymphoma within the past two years. To develop the 3RP-Lymphoma, the
      investigators conducted interviews with patients who had recently completed treatment to
      learn about their experiences and their preferences for topics they would want to include in
      a program tailored to their specific needs. The current phase of the feasibility study will
      examine if the adapted program is feasible, acceptable, and helps promote stress management
      among lymphoma survivors who are in the early stages of completing cancer treatment.
    

Intervention name(s): 3RP-Lymphoma
Intervention type(s): Behavioral
Intervention description(s): An adapted version of the Relaxation Response Resiliency Program (3RP) for individuals who have recently completed treatment for lymphoma.
Other intervention name(s): Relaxation Response Resiliency Program for Lymphoma
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Lymphoma
Clinical Evaluation of Etafilcon A With Ketotifen
Condition: Visual Acuity
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical study is a randomized, double-masked, bilateral, controlled, two-arm parallel
      group, multi-site, 1-Week, 2-visit dispensing study. Subjects between the ages of 18-40 will
      be randomized into a placebo arm or an investigational K-Lens arm.
    


Intervention name(s): etafilcon A with ketotifen; 1-Day ACUVUE
Intervention type(s): Combination Product; Device
Intervention description(s): Etafilcon A with ketotifen; 1-Day ACUVUE
Intervention MeSH terms: Ketotifen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Influence of day-to Day BPV on Long-term Adverse Outcomes in Patients Ischemic Stroke
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Observational

Summary: 
      Stroke is one of the most devastating disorder worldwide. Hypertension has been confirmed to
      be a major modifiable risk factor for stroke.Even the casual visit hypertension has been
      managed ideally,there is still surplus risk for stroke re-attack.The purpose of this study is
      to explore whether variation of 24-hour ambulatory and visit-to-visit blood pressure
      variability (BPV) contribute to recurrent stroke.
    

Detailed description: 
      System hypertension has been reported to play the most important role in the development of
      stroke,and the anti-hypertension therapy is regarded as the cornerstone for stroke secondary
      prevention. However, even though some proper measures have been taken,there is still surplus
      risk for recurrent stroke. Recently the variation of system blood pressure has been focused
      as the candidate of another risk factor.Up to date,this hypothesis remains an intense debate
      and few studies has been done to clarify it.Besides, the definition of BPV and measurement of
      BPV parameters are still beyond conformity.In the current study, the long-term and short-term
      BPV will be taken respectively for patients with prior stroke. Bsed on these parameters, the
      cohort will be followed up for average 2 years. The predefined outcome include composite
      cardiovascular events, neuropsychiatric wording, and mortality during followup.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with acute ischemic stroke, which should be verified by define radiological
        evidences and acute onset of clinical manifestations.
      
Keywords: stroke, blood pressure, prognosis
Botulinum Toxin A for the Treatment of Keratoconus
Condition: Keratoconus
MeSH terms: Keratoconus
Study type: Interventional

Summary: 
      The purpose of this study is to associate the use of botulinum toxin type A for patients with
      keratoconus to demonstrate that tension eyelid has an important role in disease progression.
    

Detailed description: 
      Subcutaneous injection of botulinum toxin type A will be performed at two points in a nasal
      and temporal extent of the orbicularis muscle of a group of patients with keratoconus
      (Botulinum toxin A group).The idea is to evaluate the change in palpebral fissure in patients
      from group botulinum toxin A over a period of 18 months.The measurements of the palpebral
      fissure will be performed by the Image J (version 1.34s) program, developed by the National
      Institutes of Health (USA).The unit of measure is the millimetre.The patients of the
      botulinum toxin A group will be compared with a control group, without any intervention.
    

Intervention name(s): Subcutaneous injection of botulinum toxin type A; Botulinum Toxin Type A
Intervention type(s): Procedure; Drug
Intervention description(s): Subcutaneous injection of botulinum toxin type A (2.5 units per application point) at two points in a nasal and temporal extent of the orbicularis muscle will be performed in the Botulinum toxin type A group.; 2.5 units per point of application at two points in a nasal and temporal extent of the orbicularis muscle.
Other intervention name(s): Botox (Allergan)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Keratoconus; Tetanus toxin
A Study to Investigate Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ 61393215 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and tolerability of JNJ-61393215 after
      multiple consecutive dose administrations and to characterize the pharmacokinetics (PK) of
      JNJ-61393215 in plasma after multiple consecutive dose administrations.
    


Intervention name(s): JNJ-61393215; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive JNJ-61393215 for 7 days.; Participants will receive JNJ- 61393215 matching placebo for 7 days.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Genotype 1 Chronic Hepatitis C Virus Infection and Cirrhosis
Condition: Hepatitis C Virus Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Virus Diseases; Hepatitis C; Hepatitis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to investigate the efficacy and safety of 12 weeks of simeprevir
      (150 mg qd) in combination with sofosbuvir (400 mg qd) in chronic hepatitis C virus (HCV)
      genotype 1 infected men and women with cirrhosis who are HCV treatment-naïve or
      treatment-experienced.
    

Detailed description: 
      This is a open-label (all people know the identity of the intervention), single arm,
      multicenter study. The study will consist of a screening phase up to 4 weeks, open-label
      treatment phase of 12 weeks, and post-treatment follow up phase up to 24 weeks after end of
      treatment. Approximately 100 participants will receive 150 mg simeprevir in combination with
      400 mg sofosbuvir once dailyfor 12 weeks. Safety evaluations will include assessment of
      adverse events, clinical laboratory tests, vital signs, and physical examination. The maximum
      study duration for each participant will be approximately 40 weeks.
    

Intervention name(s): Simeprevir; Sofosbuvir
Intervention type(s): Drug; Drug
Intervention description(s): 100 participants will receive 1 capsule of 150 mg orally once daily for 12 weeks.; 100 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 12 weeks.
Intervention MeSH terms: Sofosbuvir; Simeprevir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C Virus Infection; Simeprevir; Sofosbuvir; HCV; Cirrhosis
A Study to Assess the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Intranasally Administered Esketamine
Condition: Renal Impairment; Healthy
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics of a single dose of
      intranasally administered esketamine in participants with impaired renal function when
      compared to participants with normal renal function.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), single-dose,
      single-center, parallel group study to characterize the pharmacokinetics and safety of a
      single 28 milligram (mg) dose of esketamine in both participants with varying stages of renal
      impairment and healthy participants. A total of approximately 32 medically stable men and
      women with varying degrees of renal function impairment or no renal impairment will be
      enrolled. The study consists of a Screening period of up to Days -21 to -2, open label phase
      of Days -1 to 4, and end-of-study (11 plus [+] or minus [-] 2 days after final dose). The
      participants will be assigned to 1 of 4 groups (8 participants per group) based on creatinine
      clearance (CLCR,m). Safety and tolerability will be assessed from the time of consent until
      the end of the study.
    

Intervention name(s): Esketamine
Intervention type(s): Drug
Intervention description(s): Participants will self-administer esketamine solution intranasally 28 milligram (mg) on Day 1.
Other intervention name(s): JNJ-54135419
Intervention MeSH terms: Esketamine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Renal Impairment; Healthy; Esketamine
Effect of Fee on Attendance in Cervical Cancer Screening
Condition: Cervical Dysplasia
MeSH terms: Uterine Cervical Dysplasia
Study type: Interventional

Summary: 
      Several reasons can explain non-attendance in cervical cancer screening. In low resource
      settings the attendance is even lower. The effect of fee as contributing reason of non
      attendance has not been studied before why the investigators decided to study this in a low
      resource setting as a randomised trial.
    

Detailed description: 
      Non-attendance in the cervical cancer screening programme is the most important factors why
      Swedish women contract the disease. Low attendance rate is observed in districts with low
      socioeconomic resources. Several reasons can explain this, including the existence of a fee.
      A low attendance rate in low resource districts is also noticed in Gothenburg, Sweden. After
      multiple interventions the coverage has slightly increased. None of the interventions
      included the aspect of the fee. The investigators decided to study the effect of fee
      abolishment in a randomized control trial emanating from the regular cervical
      cancer-screening program. Method: Randomized Control Trial (RCT). Women in low resource areas
      of Gothenburg, due for screening, January-July 2013, were randomised to receive an offer of a
      free test or receiving the regular invitation stating the regular fee of 100 Swedish kronor
      (SEK) (≈11 €). Power calculation has shown 80 % power to detect an increase in participation
      of 20% at 1972 participants.
    

Intervention name(s): Screening without fee
Intervention type(s): Other
Intervention description(s): All women in three districts in Gothenburg, Sweden, that were eligible for invitation in the regular screening program were individually randomized by computer program in two parallel arms 1:1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Screening
Keywords: Attendance; Screening without fee
An Appearance-Based Intervention to Reduce Teen Skin Cancer Risk
Condition: Skin Cancer
MeSH terms: Skin Neoplasms
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a skin cancer prevention website is
      effective at reduce female teenagers' desire to use indoor tanning and ultimately their use
      of indoor tanning over an 18 month period.
    

Detailed description: 
      The project is designed to improve the understanding of, and ability to affect UV risk
      behavior in teenage populations. The International Agency for Research in Cancer classifies
      indoor tanning as "carcinogenic to humans." There is evidence that female indoor tanning use
      increases dramatically from freshman to senior years of high school (e.g., 25-40% of older
      high school girls) making high school a critical time period for anti-tanning interventions
      to be carried out. This proposal assesses the effectiveness of a skin cancer prevention
      website for a nationally representative sample of high school teens in a randomized
      controlled trial. Teens exposed to the website will report reduced indoor tanning intentions,
      frequency and overall percentage of users while increasing sun protective behaviors at
      long-term (i.e 18 month) follow-up.
    

Intervention name(s): Appearance-Focused Website Intervention; Control Website
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.; The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Melanoma; Basal Cell Carcinoma; Squamous Cell Carcinoma
De Novo Lipogenesis of Sebaceous Glands in Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Early Phase 1

Summary: 
      There are two purposes of this study:

        1. First, the investigators want to see what the differences are in de novo sebaceous lipid
           production of people with and without acne.

        2. Secondly, the investigators want to know what happens to sebaceous gland de novo lipid
           production before and after treatment with topical tretinoin and oral isotretinoin.
    

Detailed description: 
      The primary objective of this study is to understand how de novo lipid production of
      sebaceous glands are altered in acne and with acne directed therapy.

      Hypothesis 1: The overall de novo lipogenesis will be increased in those with acne

      Hypothesis 2: Treatment with topical tretinoin and systemic isotretinoin will reduce de novo
      lipogenesis.
    

Intervention name(s): Tretinoin; Isotretinoin
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will apply 0.5% tretinoin cream nightly to their face for a total of 12 weeks.; Subjects will take isotretinoin as prescribed by their dermatologist.
Other intervention name(s): Retin-A
Intervention MeSH terms: Tretinoin; Isotretinoin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: acne; sebaceous gland; lipid; sebum
Wiring Adolescents With Social Anxiety Via Behavioral Interventions
Condition: Social Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This study is a validation study to evaluate the acceptability, feasibility and impact of
      WASABI (Wiring Adolescents With Social Anxiety via Behavioral Interventions), a mobile
      application employing a closed-loop technology in adolescents with a Social Anxiety and to
      prepare for a large-scale efficacy trial in this population. The goal of this study is to
      evaluate WASABI-a clinician-assisted, adjunct to treatment, mobile application designed to
      augment the efficacy of psychological Evidence Based Treatments through a closed-loop
      technology.
    

Detailed description: 
      This study will employ an innovative and evidence-based mobile intervention that includes
      Ecological Momentary Assessments (EMAs) data collected from mobile devices, the WASABI
      closed-loop algorithm to detect exacerbation of social anxiety, and 1:1 and group-based
      videoconferencing and Instant Messaging with peers and providers. This study will test WASABI
      as an adjunct to digital Cognitive Behavioral Group Therapy (dCBGT) in adolescents with
      Social Anxiety (SA), in a parallel arm, double-blind, randomized, controlled clinical trial
      to assess feasibility and initial efficacy, to investigate the generalization of trained
      cognitive skills in the natural environment and improving anxiety and social functioning, and
      to prepare for a large-scale efficacy trials in adults with adolescents with Social Anxiety.
    

Intervention name(s): dCBGT + WASABI; dCBGT Only
Intervention type(s): Other; Other
Intervention description(s): Participants in the experimental treatment group will complete daily Ecological Momentary Assessments (EMAs), 1 hour of digitally delivered Cognitive Behavioral Group Therapy (dCBGT) per week, and weekly cognitive biases assessments and self-reports for 16 weeks. Participants assigned to this intervention will also have daily access to 1:1 and group chat Instant Messaging (IM) and will have weekly electronic check-ins with study staff (as needed).; Participants in the active comparator group will be asked to attend 1 hour of digitally delivered Cognitive Behavioral Group Therapy (dCBGT) per week for 16 weeks and weekly electronic check-ins with study staff (as needed).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Derris Scandens Benth Extract VS Naproxen in Knee OA
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 3

Summary: 
      Derris Scandens Benth (family : Leguminosae) is a woody vine growing throughout Southeast
      Asia, including Thailand. The stem of D.Scandens has been widely use in Thai traditional
      medicine, foe example of myalgia. Previous study shown that D.Scandens Benth extract has the
      anti-inflammatory activity. Although NSAIDs are efficaciously in the treatment of
      osteoarthritis,but the GI side effect is still concerned. In this study we aim to investigate
      the efficacy and safety of D. Scandens Benth extract compared with Naproxen for therapy of
      patients with knee osteoarthritis.
    


Intervention name(s): Derris scandens Benth extracts; naproxen
Intervention type(s): Drug; Drug
Intervention description(s): Derris scandens Benth extracts (oral) 400 mg twice per day for 4 weeks; Naproxen 500 mg/day for 4 weeks
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Derris Scandens Benth extract; Osteoarthritis; WOMAC; 6-minute walk