bioihbjkbjnl/mcl2 huggingface dataset:
Study to Investigate the Safety, Tolerability and Pharmacokinetics of Multiple Doses of AZD8566.
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine how well tolerated and safe AZD8566 is when given
      over 10 days, at different dose levels. This study will also determine how AZD8566 is
      distributed around the body and how it leaves the body.
    


Intervention name(s): AZD8566; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10ml oral solution administered once a day over 10 days. Specific dose will be selected by the safety review committee; 10ml oral solution administered once a day over 10 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Volunteer; Safety; Tolerability; AZD8566
Single Dose Escalation Study of ONO-9054 in Healthy Volunteers
Condition: Healthy Adult Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of ascending
      single doses of ONO-9054 administered as a single drop in healthy adult subjects. The
      secondary objectives are to characterize the pharmacokinetic (PK) profile of ONO-9054 and its
      metabolite in plasma and to evaluate the pharmacodynamic (PD) profile.
    


Intervention name(s): ONO-9054; ONO-9054; ONO-9054; ONO-9054; ONO-9054; ONO-9054; ONO-9054
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Eye drops 0.3 µg/mL both eyes on Day one; Eye drops 1 µg/mL both eyes on Day one; Eye drops 3 µg/mL both eyes on Day one; Eye drops 10 µg/mL both eyes on Day one; Eye drops 20 µg/mL both eyes on Day one; Eye drops 30 µg/mL both eyes on Day one; Matched-placebo eye drops dosed in the same manner as ONO-9054 in both eyes on Day one
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ONO-9054; adult healthy volunteers; single dose; phase 1
Mindfulness Based Dementia Care Study
Condition: Caregiver Burnout
MeSH terms: Dementia; Caregiver Burden
Study type: Observational

Summary: 
      Mindfulness based stress reduction (MBSR) refers to a particular type of attention focused on
      the present moment, non-judgmental awareness, and acceptance of that experience with openness
      and curiosity. Mindfulness training was designed to enhance the range and use of coping
      skills, decrease levels of stress, improve mood, and reduce tendencies to react in
      maladaptive ways 1-3. Investigators are evaluating a new program, called the Mindfulness
      Based Dementia-Care (MBDC) in caregivers (CG) for dementia, which combines the traditional
      approaches with education. The overall objective of this study is to evaluate the program and
      explore the potential benefits of the Mindfulness Based Dementia-Care (MBDC) program.
      Investigators are conducting a prospective, pre-post, observational study with members
      participating in the MBDC program.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population is anyone who is willing and able to attend the MBDC Program.
      
Keywords: Mindfulness; Dementia
Repeat Doses Of A New Medication (GW642444) In Asthmatic Patients
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      In order to obtain information on a wider range of doses of GW642444 (a possible new
      medication to treat asthma) than has been previously examined in asthmatic patients, this
      current study will be conducted at doses of 25 100 and 400 mcg of GW642444 and will be
      compared with salmeterol (50 mcg twice daily). This study will be conducted in a similar
      manner to a study that has already been completed (study number B2C101762) which examined
      repeat doses of 50, 100 and 200 mcg of GW642444. The data obtained will compliment the data
      from study B2C101762 and will provide confidence (or not) that the desired bronchodilation
      can be achieved and maintained without undesirable side effects.
    


Intervention name(s): GW642444 (25, 100 & 400 mcg/day); Salmeterol 50mcg
Intervention type(s): Drug; Drug
Intervention description(s): 25, 100 and 400mcg/dose; Salmeterol 50mcg
Intervention MeSH terms: Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Tolerability; Pharmacodynamics; Safety; Pharmacokinetics; GW642444; Asthmatic patients; Efficacy
To Evaluate the Safety and Pharmacokinetic Characteristics After the Administration of JC-001 and JLP-1901
Condition: Healthy Adult
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and pharmacokinetic characteristics after the administration of JC-001
      and JLP-1901
    

Detailed description: 
      An open-label, randomized, single administration, full replicated crossover phase 1 clinical
      trial to compare pharmacokinetics and safety between JLP-1901 and JC-001 in healthy subjects
    

Intervention name(s): JLP-1901; JC-001(active comparator)
Intervention type(s): Drug; Drug
Intervention description(s): administration of JLP-1901; administration of JC-001(tenofovir)
Other intervention name(s): anti-viral; tenofovir
Intervention MeSH terms: Tenofovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immunonutrition Versus Standard Enteral Nutrition Before Major Surgery
Condition: Major Abdominal Surgery
Study type: Interventional

Summary: 
      The aim of this trial is to compare preoperative Imunnonutrition with standard enteral
      nutrition regarding morbidity after major abdominal surgery in patients with NRS greater 3.

      The primary end point is the complication rate until 30 days after surgery.
    

Detailed description: 
      Malnutrition affects about 20-50% of all patients in hospital [1, 2]. Major surgery further
      increases postoperative malnutrition and immunity reduction. Therefore, postoperative
      complication and infection rates after major surgery exceed 30% [3-6].

      The nutritional risk score (NRS) [1] is based on the ESPEN (European society of parenteral
      and enteral nutrition) screening guidelines and identifies patients who are likely to benefit
      from nutritional support. Patients with a NRS ≥ 3 are considered severely undernourished, or
      to have a certain degree of severity of disease in combination with certain degree of
      malnutrition [7].

      In a prospective cohort study patients with a NRS ³ 3 had significant more infectious and
      overall complications after major abdominal surgery [4, 7, 8]. Several studies showed a
      benefit by nutritional support on complications [3, 5, 6]. International guidelines suggest
      therefore preoperative oral nutritional support for malnourished patients undergoing major
      surgery [9]. However, it remains controversial whether standard enteral nutrition (SEN) or
      immunonutrition (IN) is preferable [9].

      IN, containing arginine, ribonucleic acid and omega-3 polyunsaturated fatty acids aims to
      improve the nutritional status, immunological function and clinical outcome [5, 10].
    

Intervention name(s): Immunonutrition for 5 days preoperative; Standard enteral nutrition for 5 days preoperative
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Impact vs Meritene; Impact vs Meritene
Other intervention name(s): Impact, Meritene; Impact vs Meritene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: preoperative Immunonutrition; major abdominal surgery; complication
A Study of the Effect of MK-8457 on Blood Pressure in Hypertensive Participants (MK-8457-004-AM1)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the effect of treatment with multiple doses of MK-8457 on systolic
      blood pressure in participants with mild to moderate hypertension in addition to safety and
      tolerability. The study hypothesis is that MK-8457 does not increase systolic blood pressure
      to a clinically significant extent, as measured by 24-hour mean ambulatory systolic blood
      pressure change from baseline after 10 days of dosing.
    


Intervention name(s): MK-8457; Placebo for MK-8457
Intervention type(s): Drug; Drug
Intervention description(s): 10 x 10-mg capsule BID for 10 days; 10 x 10-mg capsule BID for 10 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Novel Metabolites of Beta-Carotene and Lycopene
Condition: Healthy
Study type: Interventional

Summary: 
      The study (n = 36) will be a parallel design and will be 6 weeks in duration. Participants
      will start with a 2-week free-living wash-in period where they will be asked to avoid certain
      carotenoid-rich foods, followed by 4 weeks of a completely controlled diet. In addition to
      the controlled diet, participants will consume one of three beverages (300 mL/day; n =
      12/group): placebo beverage (control), high beta-carotene tomato juice, and high-lycopene
      tomato juice. Blood, urine and feces will be collected throughout the study.
    


Intervention name(s): Base diet + high beta-carotene tomato juice; Base diet + high lycopene tomato juice; Base diet + placebo beverage
Intervention type(s): Other; Other; Other
Intervention description(s): Participants will receive high beta-carotene tomato juice daily in addition to the base diet. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. The base diet will be low in betacarotene and lycopene (no carrots, sweet potato, tomatoes, and dark greens). During the controlled diet period, participants will be instructed to eat all foods and only foods provided to them, with the exception of water, coffee, tea, and diet soda.; Participants will receive high lycopene tomato juice daily in addition to the base diet. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. The base diet will be low in betacarotene and lycopene (no carrots, sweet potato, tomatoes, and dark greens). During the controlled diet period, participants will be instructed to eat all foods and only foods provided to them, with the exception of water, coffee, tea, and diet soda.; Participants will receive a placebo beverage daily in addition to the base diet. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. The base diet will be low in betacarotene and lycopene (no carrots, sweet potato, tomatoes, and dark greens). During the controlled diet period, participants will be instructed to eat all foods and only foods provided to them, with the exception of water, coffee, tea, and diet soda.
Intervention MeSH terms: Beta Carotene; Lycopene; Carotenoids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Healthy volunteers
Improving Treatment Engagement for Adolescents With Bulimia Nervosa
Condition: Eating Disorders
MeSH terms: Bulimia; Feeding and Eating Disorders; Bulimia Nervosa
Study type: Interventional

Summary: 
      Although 4.7% of adolescents suffer from symptoms of bulimia nervosa (BN), only 1/5 seek
      treatment. Hesitation to seek treatment is likely related to ego-syntonicity and fear of
      disclosing symptoms to parents and clinicians. Furthermore, the physical symptoms of BN often
      go unnoticed by parents and clinicians.

      In order to eliminate the barriers that prevent adolescents from seeking treatment, this
      study will offer anonymous access to online self-help cognitive behavioral therapy (CBT) for
      BN. Online CBT (traditional, non-anonymous delivery) has been found to be effective and
      acceptable treatment for adolescents with BN. Furthermore, in adults, this method has been
      found to be as effective as specialized treatments, and more cost efficient.

      To remain anonymous and accessible, the self-help approach in this study will be provided in
      a non-guided, or pure format (only online sessions). Studies support that a pure self-help
      methodology is as effective as a guided version.

      Although anonymity may improve accessibility, this study design could also pose challenges in
      areas such as recruitment, treatment completion and obtaining adequate informed consent.
      Therefore, before embarking on a larger randomized control trail, we would like to propose a
      small, non-controlled feasibility study to assess potential issues in these areas.

      Primary hypotheses:

      Recruitment: Based on communication with public health nurses in the high schools we plan to
      recruit from, we hypothesize that it is feasible to recruit 1-5 adolescents over a 4-month
      period from each of the 5 schools, and 1-5 from social media outlets such as Instagram,
      Twitter, Facebook for a total of 5 participants over a 4-month period.

      Treatment completion: Based on pervious studies of self-help for adolescent bulimia, we
      hypothesize that approximately 15% of participants will not complete any sessions, and many
      will only complete about half of the sessions.

      Informed consent: Based on information from large randomized control studies in the UK, we
      hypothesize that adolescents will be capable of providing online consent, and that we will be
      able to adequately obtain consent without verbally communicating with participants.

      Secondary hypothesis:

      We hypothesize a non-guided (pure) version of online CBT-BN offered in an anonymous manner
      will decrease BN symptoms after treatment completion, and at 3-month follow-up compared to
      baseline.
    


Intervention name(s): Overcoming Bulimia Online Programme
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eating Disorders; Self Help; Anonymous CBT
MS PATHS Normative Sub-Study
Condition: Healthy Volunteer
Study type: Observational

Summary: 
      The primary objective of this study is to determine the normative range of brain volume and
      brain volume change in healthy control (HC) participants whose age, race, and gender
      distribution is approximately matched to the age, race, and gender distribution of patients
      with Multiple Sclerosis (MS) enrolled in Study 888MS001. The secondary objective is to use
      the results of the primary endpoint to ensure consistency of brain volume measurements across
      MS PATHS centers.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy control (HC) participants enrolled at each institution will be carefully selected
        to result in a group whose age, race, and gender distribution is approximately matched to
        the age, race, and gender distribution of patients with MS enrolled in MS PATHS at that
        center. Patients enrolled in MS PATHS at each center will be encouraged to enlist a friend
        or family member to participate in the study as an HC. Subsequently, on approximately
        quarterly review of participant participation, particular demographic groups will be
        targeted for recruitment, if needed, in order for the age, race, and gender distribution of
        a center's HC sample to be similar to their MS PATHS participant sample (within the study
        age range).
      
Biospecimen description: 
      Ribonucleic acid (RNA), serum, and whole blood biomarker samples
    
Keywords: Imaging research
Characteristics of the Intestinal Microbiota in Patients With Cancer
Condition: Oncology
MeSH terms: Neoplasms
Study type: Interventional

Summary: 
      In order to understand how the intestinal microbiota plays a role in the effectiveness of an
      anti-cancer treatment by an immune control point inhibitor, this study aims to constitute a
      catalog of microbial genes of a patient with cancer. This catalog will help to characterize
      the intestinal microbiota of cancer patients and to be able to use this catalog as a
      reference tool for screening the microbiota of patients treated with immune control point
      inhibitors. To produce this catalog, five types of cancer were selected: non-small cell lung
      cancer, colorectal cancer, hepatocellular carcinoma, breast cancer and prostate cancer.

      The metagenomic analysis of a group of five different types of cancers introduces a lot of
      heterogeneity which is favorable to the richness of a catalog. For non-small cell lung cancer
      treated with immune control point inhibitors, two stool collections will be performed per
      patient (one stool collection before setting up an immune control point inhibitor and one
      collection after one month of being inhibited Of immune control point) to assess the impact
      of the immune control point inhibitor on the microbiota (pilot study). For this study, two
      stool collection tubes containing different preservative solutions will be used (one RNAlater
      tube and one DMSO-EDTA tube for Dimethylsulfoxide-Ethylene diamine tetraacetic acid).

      In parallel, we will also collect samples of serum and plasma to evaluate, in a second step,
      protein markers in circulating blood.
    

Detailed description: 
      Primary objective: Develop a catalog of microbial genes dedicated to oncology (Onco catalog)
      by sequencing stool specimens from patients with cancer.
    

Intervention name(s): Collection of stool and serum samples
Intervention type(s): Biological
Intervention description(s): During the inclusion visit (for the 5 cancer sites): Stool collection (1 tube RNA later + 1 tube DMQO-EDTA) +Blood sample (1 tube SST + 1 tube EDTA)
1 month after treatment (only for non-small cell lung cancer): Stool collection (1 tube RNA later + 1 tube DMQO-EDTA) + Blood sample (1 tube SST + 1 tube EDTA)
Intervention model: Single Group Assignment
Intervention model description: This cohort will consist of 55 patients as described below:
non-small cell lung cancer (NSCLC)
hepatocellular cancer:
colorectal cancer
breast cancer
prostate cancer
glioblastoma
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Intestinal microbiota, microbial genes, oncology
Clinical Trial To Evaluate ANT-1207 In Participants With Primary Axillary Hyperhidrosis
Condition: Hyperhidrosis
MeSH terms: Hyperhidrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to establish the therapeutic range of ANT-1207 in the treatment
      of primary axillary hyperhidrosis.
    


Intervention name(s): Vehicle; ANT-1207
Intervention type(s): Biological; Biological
Intervention description(s): Vehicle for ANT-1207 liniment formulation without active ingredient.; Botulinum toxin Type A topical liniment (ANT-1207).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
When do School-aged Patients Return to School After ACL Surgery?
Condition: ACL Reconstruction
Study type: Observational

Summary: 
      We intend to survey school aged patients following ACL surgery on when they return to school.
      We will analyze independent variables to determine if any relationship exists that may
      influence the amount of time missed.
    

Detailed description: 
      All patients undergoing ACL surgery who are enrolled in middle or high school will be
      recruited for study participation. Patients undergoing concomitant additional ligament
      surgery will be excluded. The only procedure will be to answer a short written questionnaire
      asking when they returned to school and what accommodations, if any, the school made
      available for them. This will occur at the patient's 2 week post-operative clinic visit. This
      clinic visit is a standard of care visit. Independent variables will be collected from the
      medical record and are all standard of care information routinely collected from this patient
      populations (age, sex, race, date of surgery, surgeon, sport played, grade, ACL surgery graft
      type, associated meniscal or chondral surgery, length of post-operative narcotic use,
      regional nerve block at the time of surgery, SANE score, IKDC score, brace used).
    

Intervention name(s): observe when return to school after surgery
Intervention type(s): Other
Intervention description(s): Short written questionnaire asking when they returned to school and what accommodations, if any, the school made available for them
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        School aged patients who undergo ACL reconstruction surgery during the school year
A Study in Healthy Men to Test Whether BI 1358894 Reduces Druginduced Panic Symptoms
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the pharmacodynamic effects of a single
      dose of BI 1358894 on CCK-4- induced anxiogenic/ panic-like symptoms using the PSS in
      preselected CCK-4 sensitive healthy volunteers.
    


Intervention name(s): BI 1358894; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Film-coated tablet; Film-coated tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Viscoelastic Properties of Lower Extremity's Muscles
Condition: Muscle Loss
Study type: Interventional

Summary: 
      This study aims to create normative values for stiffness, tonus and elasticity in the lower
      extremity muscles and to determine age and gender differences.
    


Intervention name(s): Myotonometric evaluation
Intervention type(s): Diagnostic Test
Intervention description(s): Vertically placed on the muscle, a probe (3 mm diameter) creates constant pre-excitations (0.18 N) and generates short-term (15 ms), low-force (0.4 N) mechanical stimulations.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Muscle tone; viscoelastic properties; aging