bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Skin Attributes Following Dietary Supplement Consumption
Condition: Skin Condition
MeSH terms: Skin Diseases
Study type: Interventional

Summary: 
      The study is to assess skin attributes of female subjects following 16 weeks of dietary
      supplement consumption.
    

Detailed description: 
      This is a 16 week, randomized, double blind, placebo controlled study. Approximately 105
      Caucasian and Asian (Korean, Japanese, or Chinese) female subjects will be enrolled. The
      following clinical assessments will be performed: (1)VISIA-CR™ digital photography; (2)AGE
      Reader SU measurements on the left cheek and left inner forearm; (3) Visual Analog Grading
      (VAS); (4) Corneometer measurements; and (5) Cutometer measurements. Subjects will return to
      the clinic at approximately 4 weeks, 8 weeks and 16 weeks from the baseline visit for similar
      measurements. A self-perception questionnaire will be administered at the conclusion of the
      study.
    

Intervention name(s): Low dose Polyphenol; High dose Polyphenol; Placebo Control
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): botanical supplement with 25 mg polyphenol; botanical supplement with 13 mg polyphenol; inert tablet made to mimic the experimental tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: individuals are assigned prospectively to two different interventions according to a protocol, to evaluate the effect of the interventions
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: dicarbonyl compounds; skin elasticity; glycation
Pre-Discharge Bundle for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease to Reduce Readmissions
Condition: Chronic Obstructive Pulmonary Disease; Exacerbation of Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      Hospital readmissions for acute exacerbations of chronic obstructive pulmonary disease
      (AECOPD) pose burdens to the healthcare system and patients. The aim of this study was to
      determine whether a screening and educational tool, administered prior to discharge, would
      result in a decrease in the rate of hospital readmissions.
    

Detailed description: 
      Hospital readmissions for acute exacerbations of chronic obstructive pulmonary disease
      (AECOPD) pose burdens to the healthcare system and patients. A current gap in knowledge is
      whether a pre-discharge screening and educational tool, administered to patients with COPD,
      reduces readmissions and emergency department (ED) visits.

      A single center, randomized trial of patients admitted with AECOPD. Patients will be
      randomized to control (standard care) or "bundle" group in which patients receive smoking
      cessation counseling, screening for gastroesophageal reflux disease and depression or
      anxiety, standardized inhaler teaching, and a 48-hour post-discharge phone call.
    

Intervention name(s): Bundle tool
Intervention type(s): Behavioral
Intervention description(s): Tool consists of 1. screening measures to identify the presence of various risk factors for COPD exacerbations and 2. Educational components for the disease of COPD.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Chronic Obstructive Pulmonary Disease; COPD; Readmissions
A Phase 1 Study to Evaluate PK, Safety and Tolerability of AMG 416
Condition: Secondary Hyperparathyroidism
MeSH terms: Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a multiple-dose, double-blind, randomized, placebo-controlled study. Chinese
      subjects residing in Mainland China with chronic kidney disease (CKD) receiving hemodialysis
      were randomized in a 3:1 ratio to receive 5 mg intravenous (IV) of etelcalcetide or placebo 3
      times a week (TIW) for approximately 4 weeks, with a subsequent follow up period of
      approximately 4 weeks.

      Doses were given at the end of each scheduled hemodialysis session on study days 1 through
      day 27 and subject participation was complete after day 55 end-of-study (EOS) procedures were
      performed. Doses were administered TIW for 4 weeks, for a total of 12 doses.
    


Intervention name(s): Etelcalcetide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Etelcalcetide was supplied as a sterile, preservative-free, aqueous solution in a single-use 3 mL glass vial.; Placebo supplied to match active intervention.
Other intervention name(s): AMG 416
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a multiple dose, double-blind, randomized, placebo-controlled clinical study conducted in Chinese subjects residing in Mainland China with chronic kidney disease receiving hemodialysis. The treatment duration will be approximately 4 weeks with a post treatment followup of 4 weeks. A dose will be given at each scheduled hemodialysis session (Dose administered three times a week for 4 weeks, for a total of 12 doses).
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Secondary hyperparathyroidism; Chronic kidney disease CKD; Intact parathyroid hormone iPTH; Hemodialysis
A Single-dose Study to Investigate the Pharmacokinetics of Intravenous FEP-TAZ in Patients With Renal Impairment
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, open label, single-dose, pharmacokinetic study to be conducted in male and
      female subjects with normal and impaired renal function. The study will be composed of five
      groups of patients with mild (6 patients), moderate (6 patients), severe (6 patients) renal
      impairment, end stage renal disease patients on hemodialysis (6 patients) and their
      respective matched controls in 1:1 ratio (24 healthy subjects with normal renal function).
    


Intervention name(s): Cefepime and Tazobactam combination
Intervention type(s): Drug
Intervention MeSH terms: Tazobactam; Cefepime
Intervention model: Single Group Assignment
Masking: None (Open Label)
Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study In Subjects With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis (ALPINE 2/3)
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center evaluation of NGM282 in a randomized, double-blind, placebo-controlled
      study administered for 24 weeks in participants with histologically confirmed NASH and F2/F3
      Fibrosis.
    


Intervention name(s): NGM282; Placebo
Intervention type(s): Biological; Other
Intervention description(s): NGM282; Placebo for NGM282
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Blood Sugar Response to Commercial Nutritional Supplements in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of the study is to determine which of the commonly used meal supplements is the
      best product for patients with DM. This is important because meal supplements are becoming
      more popular as meal replacements in the United States. Peak blood sugar occurs about 2 hours
      later after a meal. Therefore, the best product would be the one that produces a smallest
      rise in blood sugar.
    

Detailed description: 
      The purpose of the study is to determine which of the commonly used commercial nutritional
      supplements are preferential for patients with Diabetes Mellitus (DM). We will compare the
      post-prandial blood glucose (BG) responses in response to 3 different nutritional supplements
      each containing 50 grams of carbohydrate in adult patients with type 2 diabetes mellitus and
      relate these responses to one of the two well-recognized indices of insulin sensitivity -
      HOMA-R and QUICKI.
    

Intervention name(s): Glucerna; Ensure; SlimFast
Intervention type(s): Dietary Supplement
Intervention description(s): Each participant will consume all three nutritional supplements randomly assigned by computer program to drink one of the three products in one week intervals. Each product will contain 50 grams of carbohydrate but differs in volume, fat, protein, and fiber composition. BG will be tested by finger sticks before (fasting) and at 15, 30, 60, 90, 120, 150 and 180 minutes after drinking the supplement. The participants will have 8 finger stick blood sugar measurements over about 3 hours on each of the 3 testing days.
Other intervention name(s): Glucerna Weight Loss Shake;Ensure with Fiber;SlimFast Shake
Intervention model: Single Group Assignment
Masking: None (Open Label)
Diabetes Adolescent and Family Group Therapy
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      In this research study the investigators want more about how being in a group about diabetes
      helps your family versus individual treatment. The investigators are now asking youth with
      recently diagnosed (<1 year) diabetes and their parents to be in the research, because the
      investigators want to see if this diabetes group and/or individual therapy is helpful to your
      coping, adjustment, and family communication about diabetes.
    

Detailed description: 
      The purpose of this research study is to find out what effects the Group Therapy Project has
      on parents and child's management of Type 1 Diabetes Mellitus (T1DM) from both a group versus
      an individual therapy modality. We want to start a group and individual therapy program that
      looks at youth and family adjustment and coping at the Cincinnati Children's Hospital with
      patients who have T1DM. There has been research before on this group therapy and we want to
      look at it in a "typical" clinical setting at Cincinnati Children's Hospital for both group
      and individual therapy, including recently diagnosed patients (<1 year). This research is
      being done to understand how a peer and family-based group versus individual therapy can be
      helpful by looking at survey data as well as medical data before and after participating in
      the diabetes therapy program. This information will help us further develop prevention and
      intervention programs for other youth with T1DM and their families.
    

Intervention name(s): Group Therapy
Intervention type(s): Behavioral
Intervention description(s): Self-management Diabetes Protocol: Successful adjustment to daily diabetes management requires a wealth of clinical knowledge, solid problem-solving and coping skills to deal with the physical, social and emotional factors associated with caring for and living with a chronic illness, and motivation to take care of one's health.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Youth; Family; Group Therapy; Type 1 Diabetes Mellitus; Self-Management
Clinical Evaluation of Silk'n Glide for Face
Condition: Hirsutism
MeSH terms: Hirsutism
Study type: Interventional

Summary: 
      This is a clinical study to determine the efficacy and safety of the Glide, hair removal
      photo-depilation device, for removing facial hairs. During the first stage, the subjects will
      perform up to 6 face treatments, two weeks apart. The treatment's safety and efficiency will
      be evaluated at 4 weeks of after last treatment and at 12 weeks after last treatment.
    

Detailed description: 
      Study efficacy assessment:

      Comparison of hair counts before treatments to 4 and 12 weeks follow up visits.

      Study safety assessment:

        1. Reported errors and near errors using the device

        2. Device malfunctions which relate to device safety

        3. Device related adverse events

        4. Non device related adverse events (secondary endpoint)
    

Intervention name(s): Glide
Intervention type(s): Device
Intervention description(s): 6 facial hair reduction treatments with the Glide device, two weeks apart.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: at Home Photo depilation device, Silk'n.
Immune Diversity Response to Oral Dosing of Nutritional Health Products in Healthy Participants
Condition: Immunity Disorders
MeSH terms: Immune System Diseases
Study type: Interventional

Summary: 
      A Phase IV, open-label, adaptive, 4-arm, multi-dose, single-centre, exploratory trial to
      assess the immune diversity response to oral administration of licensed Natural Health
      Products, in healthy adults, 60-70 years of age.
    

Detailed description: 
      In this study, the effect of licensed Natural Health Products (NHP) on immune
      response-related/antibody diversity parameters will be measured. Immune repertoire changes
      will be measured by genetic sequencing of segments of mRNA in the participant's blood that
      correspond to the coding regions for the Complementarity Determining Region - 3 (CDR-3) of T-
      and B-cell surface receptors. CDR-3 receptor segments are the highly variable recognition
      elements of the T- and B-cell receptors responsible for the recognition of foreign cells and
      other entities. This recognition step is an early step in the adaptive immune response.

      Each of the four arms in the study contains 8 participants and each arm is assigned one NHP:
      Palmitoylethanolamide, or Echinacea purpurea, or Curcumin, or N-Acetyl-L-cysteine (NAC).

      Longitudinal changes in immune diversity and dynamics, as indicated by changes in the CDR-3
      sequence information will be measured over five timeframes in an four week period.

      Baseline dynamics and diversity will be measured by comparing the results from participant
      visits 2 and 3. The impact of the NHP will be evident from comparing results between Visits 3
      and 4. Finally, the impact of stopping the NHP dosing will be evident in comparing the
      results from Visit 5 to those of 4, 3, and 2. The techniques being used to analyze the
      sequence information are exploratory.
    

Intervention name(s): N-Acetyl-L-cysteine (NAC); Echinacea purpurea; Curcumin; Palmitoylethanolamide
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Health Canada Natural Product Number (NPN) 80056946; Health Canada Natural Product Number (NPN) 80093896; Health Canada Natural Product Number (NPN) 80043455; Health Canada Natural Product Number (NPN) 80097472
Other intervention name(s): NAC
Intervention MeSH terms: Palmidrol; Acetylcysteine; Curcumin; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 8 participants assigned to Palmitoylethanolamide 8 participants assigned to Echinacea purpurea 8 participants assigned to Curcumin 8 participants assigned to N-Acetyl-L-cysteine
Masking: None (Open Label)
Primary purpose: Treatment
Urdu Translation of Duke Activity Status
Condition: Heart Diseases
MeSH terms: Heart Diseases
Study type: Observational

Summary: 
      To translate, culturally adapt, and validate the Duke Activity Status Index (DASI) to the
      Pakistani Urdu language. The study will measure the reliability & validity of DASI in the
      Urdu version.No study has been conducted in the Pakistan region to translate DASI which
      follows the proper cross-culture adaptation.
    

Detailed description: 
      Literature suggested that Duke Activity Index (DASI) is a questionnaire originally developed
      in English To evaluate the functionality. DASI was used primarily to assess patients with
      cardiovascular diseases such as coronary artery disease, heart failure, myocardial ischemia,
      and infarction. In clinical practice, DASI can be used to know the effects of medical
      treatments and cardiac rehabilitation and to assist clinical decisions In controlled clinical
      trials, DASI can also be used to assess interventions and as a component for assessing the
      costs/benefits of treatment.

      Studies demonstrated that DASI is characterized as a questionnaire with good functional
      ability, evidence of validity, usefulness, and great clinical and scientific applicability,
      it seems to be a useful tool for evaluating cardiac patients. So, to be used with Brazilian
      CVD patients it is necessary to validate DASI and verify its psychometric properties in this
      population.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        To meet inclusion criteria participants will be diagnosed with heart disease, clinically
        stable, and able to read the Urdu version of DASI. Then patient response will be checked on
        the translated Urdu version.
      
Keywords: Duke activity status index; Heart Diseases; Tool Translation
To Compare the PK, PD, Safety & Immunogenicity of ADL-018 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a randomized, double blind, three-arm, single dose, parallel group, PK, PD and
      safety and immunogenicity study in healthy, adult, subjects.

      Total 306 healthy, adult, eligible human subjects (102 in each treatment arm) will be
      enrolled in the study with their consent. Required *standby subjects will also be enrolled to
      ensure that 306 subjects are dosed in the study.

      The study will be conducted in cohorts; all the study procedures will be identical as
      mentioned in the protocol for all the cohorts.
    

Detailed description: 
      This will be a randomized, double blind, three-arm, single dose, parallel group, PK, PD and
      safety and immunogenicity study in healthy, adult, subjects.

      The study objectives will be to compare the pharmacokinetics (PK), pharmacodynamics (PD) and
      to evaluate safety and immunogenicity of the Test product Vs. US-LICENSED XOLAIR and Test
      product Vs. EU-APPROVED XOLAIR following single subcutaneous dose in healthy adult subjects.

      For the purpose of this study the following eligibility assessments will be carried out
      before enrollment / during the study of any volunteer in the study.

      Assessment criteria should be fulfilled for volunteers to be enrolled in the study. The
      screening will be carried out only after taking written informed consent from volunteers.
      Once the subject becomes eligible, will get randomized to receive either ADL-018, US-licensed
      XOLAIR or EU approved XOLAIR as per the randomization schedule. This will be parallel design
      so will have only one study period. After dosing, all subjects will go for serial PK sampling
      as defined in the study protocol. All subjects will be monitored on safety grounds as
      mentioned in the study protocol.
    

Intervention name(s): ADL-018; US-licensed XOLAIR; EU-Approved XOLAIR
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 150 mg/mL, Solution for injection in PFS; 150 mg/mL, Solution for injection in PFS; 150 mg/mL, Solution for injection in PFS
Intervention MeSH terms: Omalizumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This will be parallel group design having single study period
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: ADL-018, XOLAIR
Penile Ischemia for Hypospadias Repair and The Patients and Surgeons Reported Outcomes
Condition: Hypospadias; Hypospadias, Coronal; Hypospadia, Repair; Tourniquet
MeSH terms: Hypospadias; Ischemia
Study type: Interventional

Summary: 
      Although haemostasis aimed to maintain bloodless surgical field for better exposure for the
      surgeon, cosmetic impact, and decreased breakdown of repair, there is no trials regarding the
      impact of haemostasis techniques on surgeon satisfaction during surgery and patients reported
      outcomes.
    


Intervention name(s): Tourniquet; Non-tourniquet
Intervention type(s): Procedure; Procedure
Intervention description(s): tubularized incided plate (TIP) urethroplasty plus tourniquet; tubularized incided plate (TIP) urethroplasty plus non-tourniquet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tourniquet; Hypospadias
Cool vs Room-temperature Artificial Tears
Condition: Diabetic Retinopathy With Macular Edema of Both Eyes (Diagnosis); Central Retinal Vein Occlusion With Macular Edema; Exudative Age-Related Macular Degeneration, Unspecified Eye; Cystoid Macular Edema; Ocular Surface Disease; Dry Eye Sensation; Eye Pain
MeSH terms: Macular Degeneration; Macular Edema; Diabetic Retinopathy; Retinal Vein Occlusion; Eye Pain; Edema
Study type: Interventional
Phase: Phase 4

Summary: 
      Background and Objective: To evaluate the efficacy of cooled versus room temperature
      artificial tears in reducing post intravitreal injection (IVI) ocular discomfort.

      Patients and Methods: Patients receiving IVI were randomized to either cooled or room
      temperature tears intervention groups. Both groups rated their ocular discomfort following
      IVI before intervention and again after administration of cooled or room temperature tears.
    


Intervention name(s): Refresh Plus Preservative-free Lubricant Eye Drops
Intervention type(s): Drug
Intervention description(s): Refresh Plus Preservative-free Lubricant Eye Drops at 4 degree Celsius
Intervention MeSH terms: Ophthalmic Solutions; Lubricant Eye Drops
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Effect of BI 201335 Mediated UGT1A1 (Uridine-diphosphate-glucuronosyltransferases) Inhibition in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate the effect of UGT1A1 inhibition by single and multiple oral doses of BI
      201335 on the single and multiple oral dose pharmacokinetics of raltegravir and to
      investigate safety and tolerability.
    


Intervention name(s): BI 201335 NA; Raltegravir
Intervention type(s): Drug; Drug
Intervention MeSH terms: Raltegravir Potassium
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment