bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Rosacea-related Inflammatory Biochemical Markers in Adult Skin When Treated With Oracea® vs Placebo
Condition: Rosacea
MeSH terms: Rosacea
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to determine the clinical effects of doxycycline 40 mg (30 mg
      immediate release and 10 mg delayed release beads) capsules (Oracea®) as compared to placebo
      in the skin of adults with papulopustular rosacea and to identify a correlation, if any, with
      rosacea-related inflammatory markers.
    


Intervention name(s): Doxycycline; Placebo
Intervention type(s): Drug; Other
Intervention description(s): doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules, oral, one capsule daily in the morning; Placebo, oral, one capsule daily in the morning
Other intervention name(s): Oracea®
Intervention MeSH terms: Doxycycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Buprenorphine/Naloxone - Facilitated Rehabilitation for Opioid Dependent Adolescents - 1
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare two 3-month treatments for adolescents/young adults
      who are addicted to heroin: buprenorphine/naloxone combined with psychosocial therapy and
      treatment as usual, a 7-14 day detoxification with buprenorphine and three weeks of
      psychosocial therapy.
    


Intervention name(s): Buprenorphine/naloxone
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Primary purpose: Treatment
Keywords: opioid dependence; behavioral intervention
Genotropin Treatment In Very Young Children Born Small For Gestational Age
Condition: Infant, Small for Gestational Age
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate the effect on height and psychomotor development of Growth Hormone treatment
      in very young children starting at an age of 2 years.
    


Intervention name(s): Genotropin (PN-180,307) Somatropin; Control-no treatment
Intervention type(s): Drug; Drug
Intervention description(s): Injectable Genotropin; Control-no treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mapping the MoA Behind GI Protection From Bif195
Condition: Reduction of Small Intestinal Ulceration Risk
MeSH terms: Ulcer
Study type: Interventional

Summary: 
      The trial will investigate effects of daily intake of the bacterial strain Bif195 or placebo
      when co-administered to once-daily oral intake of 300 mg of Acetylsalicylic Acid (ASA).

      The trial includes a run-in period of two weeks duration followed by a 4-week intervention
      period in which Bif195/placebo and ASA are co-administered. This period is followed by a
      6-week wash-out period before a new 4-week period is performed with a cross-over
      Bif195/placebo intervention as well as ASA co-administration. Bif195 and placebo
      interventions are performed double-blinded in randomised order in a cross-over fashion for
      each subject.
    

Detailed description: 
      Subjects will participate in the trial for a total duration of approximately 17 weeks
      including the run-in phase. Besides the screening visit, the trial will consist of 4 visits.

      After having given their written informed consent, subjects will complete the screening
      procedures to evaluate their eligibility for participation in the trial and complete a run-in
      period of two weeks duration to washout possible pre-trial probiotics and/or use of
      medication. On the morning of day 4 after baseline assessments at Visit 2, all subjects will
      start daily intake of 300 mg ASA in combination with Bif195 or placebo in a ratio of 1:1
      according to the randomisation performed at Visit 2.

      At visit 2 - 5, all subjects will be biopsied from the upper small intestine and the
      ventricle during a gastroscopy procedure. At each of these 4 visits, 6 biopsies will be taken
      from pre-specified locations in the duodenum and 2 biopsies will be taken from the ventricle
      (approximately 5 mg each). Luminal fluids will also be collected during the gastroscopy
      (approximately 2 ml per visit). One venous blood sample (of 20 ml per visit) will also be
      collected at each of these visits.

      The analysis on biopsies and luminal fluid samples will include a combination of
      transcriptomic, microbiome, proteomics and metabolomics analysis.
    

Intervention name(s): Bif195; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Active trial product with minimum 100 billion CFU daily dose; Placebo similar to trial product but without Bif195
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Cumulative Irritation Test of PAC-14028 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the cumulative irritation potential of the products
      listed by the Sponsor.
    

Detailed description: 
      Healthy, adult volunteers of either sex will be patched daily on his/her arm with multiple
      strengths of PAC-14028 cream, non-active comparator and an active comparator over the course
      of 21 consecutive days. Twenty-four hours after each application, the Finn-chamber patches
      will be removed and the site evaluated using a five-point scale for irritation.
    

Intervention name(s): PAC14028-Vehicle; PAC14028-0.1; PAC14028-0.3; PAC14028-1.0; Saline; Positive
Intervention type(s): Other; Drug; Drug; Drug; Other; Other
Intervention description(s): PAC-14028 Cream Vehicle, Daily for up to 21 days; PAC-14028 Cream, 0.1%, Daily for up to 21 days; PAC-14028 Cream, 0.3%, Daily for up to 21 days; PAC-14028 Cream, 1%, Daily for up to 21 days; Saline, Daily for up to 21 days; Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days
Other intervention name(s): PAC-14208 cream vehicle; PAC-14208 Cream 0.1%; PAC-14208 Cream 0.3%; PAC-14028 Cream 1.0%; 0.9% Sodium chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Safety and Performance of a Vascular Patch in Pediatric Patients Undergoing Bidirectional Cava-pulmonary Anastomosis
Condition: Heart Defects, Congenital
MeSH terms: Heart Defects, Congenital; Congenital Abnormalities
Study type: Interventional

Summary: 
      Xeltis developed biodegradable patch prosthesis, the Vascular Patch Model COR-VP-001, to be
      used as a vascular patch to augment the pulmonary trunk and pulmonary arteries. The
      prosthesis is immediately mechanically functional, while its physiochemical characteristics
      should enable cell infiltration and tissue formation.

      The Xeltis Vascular Graft Model COR-VP-001 is specifically designed to improve surgical
      outcomes by reducing synthetic material related complications and improving hemodynamic
      characteristics.
    

Detailed description: 
      Xeltis has developed a medical device for treating pediatric cardiovascular patients
      requiring RVOT reconstruction. Xeltis' mission is to offer 'Solutions for a Lifetime' to
      cardiovascular patients. Xeltis has developed a unique technology based on novel
      biodegradable bio-materials allowing the regrowth of natural heart valves or blood vessels in
      patients' bodies from their own cells.

      The principle of Xeltis' COR technology (COR stands for Cardiovascular Organ Regeneration) is
      to implant a biodegradable prosthesis of a blood vessels that is shaped like the part to be
      replaced. The prosthesis is immediately mechanically functional, while its physiochemical
      characteristics should enable cell infiltration and tissue formation. Tissue is regenerated
      and functional by the time the polymer is biodegraded.
    

Intervention name(s): Xeltis Vascular Patch, Model COR-VP-001
Intervention type(s): Device
Intervention description(s): The intended use of the Xeltis Vascular Patch, Model COR-VP-001 is to augment pulmonary artery and thereby improve hemodynamics by increasing blood flow to the lungs in patients with congenital pulmonary artery obstructions as an initial part of the staged procedure of a bidirectional cava-pulmonary anastomosis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Exercise Program Among Lung Cancer Dyads
Condition: Lung Cancer; Depression; Physical Activity; Quality of Life; Pain; Lung Cancer Symptoms
MeSH terms: Lung Neoplasms
Study type: Interventional

Summary: 
      Pilot study of an exercise program among patients with all stages of lung cancer examining
      feasibility and acceptability. Preliminary outcomes include objective measures of physical
      function, depression, adherence to lung cancer treatments, Quality of Life (QOL), and social
      support.
    

Detailed description: 
      PRIMARY OBJECTIVE:

      I. Determine the feasibility and acceptability of a progressive exercise program initiated
      after lung cancer diagnosis among patient partner dyads.

      SECONDARY OBJECTIVE:

      I. Examine the preliminary effects of partnered exercise on physical function, depression,
      adherence to lung cancer treatments, QOL and social support .

      OUTLINE:

      Participants attend supervised group exercises classes twice per week during weeks 1-6 and
      once per week during weeks 7-12. Participants also attend home-based unsupervised exercise
      sessions via an instructional DVD once per weeks over for 30 minutes during weeks 1-6 and
      twice per week during weeks 7-12.
    

Intervention name(s): Exercise Intervention; Survey Administration; Quality-of-Life Assessment
Intervention type(s): Behavioral; Other; Other
Intervention description(s): Attend supervised and unsupervised exercise sessions; Ancillary studies; Ancillary studies
Other intervention name(s): Quality of Life Assessment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Study of Single and Multiple Ascending Doses of VIB1116 in Rheumatic Diseases
Condition: Dendritic Cell -Mediated Rheumatic Diseases
MeSH terms: Rheumatic Diseases; Collagen Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      A first-in-human study to evaluate the safety and tolerability of escalating, single and
      multiple ascending doses of VIB1116 in adult participants with rheumatic diseases.
    


Intervention name(s): VIB1116; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): VIB1116; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autoimmune disease; Rheumatic disease; Phase 1
A Study of LY3871801 in Healthy Asian and Non-Asian Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety and tolerability of LY3871801 when
      administered as multiple doses in Healthy Asian and Non-Asian Participants. The study will
      also evaluate the amount of LY3871801 that gets into the blood stream and how long it takes
      the body to get rid of it in these participants. The study will be conducted in two parts (A
      & B). The study will last up to approximately 24 days excluding the screening period.
    


Intervention name(s): LY3871801; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Can Quantitative MRI After cTACE Help Predict Survival ?
Condition: Hepatocellular Carcinoma (HCC)
MeSH terms: Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      Transcatheter arterial chemoembolization (TACE) is a widely accepted palliative therapy for
      the treatment of HCC. Palliative means that it does not cure the disease prolongs your life
      and improves quality of life. During TACE, a mixture of chemotherapy drugs is combined with
      an oil called lipiodol. Lipiodol has a role as both drug carrier and embolic agent (a
      material that blocks blood flow to tumors). The lipiodol/chemotherapy mixture is injected
      into an artery (blood vessel) directly supplying blood to a HCC tumor.

      Lipiodol is made up of fat and water which can be seen on MRI. Therefore, MRI can be used to
      quantify the amount of lipiodol delivered to the HCC tumors.

      In this study, the investigators want to see if patient survival is related to the amount of
      lipiodol delivered to HCC tumors.
    


Intervention name(s): MRI post-TACE
Intervention type(s): Other
Intervention description(s): Perform lipiodol delivery measurements with MRI post-TACE.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with hepatocellular carcinoma (HCC or cancer of the liver) and will soon undergo
        one or more transcatheter arterial chemoembolization (TACE) procedure(s).
      
Keywords: Hepatocellular; Carcinoma; HCC; lipiodol
Safety Study of Grass Pollen-derived Peptides to Treat Seasonal Allergic Rhinoconjunctivitis
Condition: Seasonal Allergic Rhinoconjunctivitis
MeSH terms: Conjunctivitis; Conjunctivitis, Allergic
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether the oral administration of grass pollen
      peptides is safe and effective in the treatment of allergic rhinitis.
    


Intervention name(s): gpASIT+TM; Placebo; gpASIT+TM; gpASIT+TM
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): entero-coated capsules containing 25µg of gpASIT+TM; placebo entero-coated capsules; entero-coated capsules containing 100µg of gpASIT+TM; entero-coated capsules containing 400µg of gpASIT+TM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hay fever; grass pollen allergy
Effectiveness of Abdominal Binder Use During Colonoscopy
Condition: Performance and Tolerance of Colonoscopy
Study type: Interventional

Summary: 
      Colonoscopy is considered the primary screening test for colorectal cancer screening
      worldwide. For technical difficulties previously experienced during colonoscopy, especially
      loop of the colonoscopy device in the colon, many solution methods have been developed and
      applied (manual pressure and position change, etc.). Although these methods are partially
      successful, there is no consensus on the optimum solution method. Few studies in the
      literature have investigated the use of corset during colonoscopy and conflicting results
      have been reported. In this study, elastic abdominal corset or false corset will be used
      during colonoscopy. Indeed, the investigators aim to determine whether this method is
      effective and safe with their own results and contribute to the literature. The primary
      outcome of this study will be the cecal intubation time. Secondary outcomes include manual
      pressure and position change during the procedure, length of cecal intubation (length of
      colonoscope required to reach the cecum from the anus), colonoscopy completion rate,
      additional anesthesia and / or analgesic requirement, patient pain and comfort level and
      colonoscopic findings.Efficacy will be assessed on the basis of pairwise comparisons between
      groups with respect to primary and secondary outcomes.
    


Intervention name(s): Abdominal Binder
Intervention type(s): Device
Intervention description(s): abdominal binder is a kind of elastic abdominal compression device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: abdominal binder; colonoscopy; loop
Prevalence of Dissociative Disorders in Children
Condition: Dissociative Disorders; Schizophrenia
MeSH terms: Schizophrenia; Dissociative Disorders; Conversion Disorder
Study type: Interventional

Summary: 
      Schizophrenia beginning before 18 years is a clinical entity not well known because of its
      low incidence and difficulties in the clinical diagnosis.

      However, in the investigators clinical practice, due to the specialization of the
      investigators service, the investigators are led to hospital to receive important feel active
      of patients meeting the Diagnostic and Statistical Manual of Mental Disorders IV text
      revision (DSM IV-TR) precose schizophrenia.

      The work of us team on the theme of the relationship between Pervasive Developmental
      Disorders and precose Schizophrenia led us to hypothesize that a number of children in care
      in the medical and educational institutes, hospitals and day shelters therapeutic part-time
      symptoms of schizophrenia or a line real early diagnosis of schizophrenia undervalued or not
      diagnosed.

      The main goal is to estimate the prevalence of dissociative disorders in a population of
      children in care institutions and medical education in child psychiatry in hospitals and
      others structures.
    


Intervention name(s): Primary stage; Secondary stage
Intervention type(s): Other; Other
Intervention description(s): Kiddie-Schedule for Affective Disorders and Schizophrenia; children who are positive to the kiddie-SADS (primary stage), will take the tests: PANSS, Scale for the Assessment of Negative Symptoms (SANS), ADI-R, scale TLC and WISC IV
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: children dissociative disorders schizophrenia
Serial Lung Function Measurements in Healthy and Mild Asthmatic Adults After Oral Inhalation of Ethanolic Solutions Containing Two Concentrations of the Excipient Butylated Hydroxytoluene (BHT) Administered With the Respimat® B (RMT-B)
Condition: Asthma
MeSH terms: Respiratory Aspiration; Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective: To investigate the safety and local tolerability of increasing cumulative
      doses (2, 4, 6 actuations) of a low (0.1%) and a high (0.5%) concentration of BHT
      administered via oral inhalation with the Respimat® inhaler B (RMT-B) vs. 2 inhalation
      solutions without BHT (placebo to BHT given by RMT B and placebo given by hydroxylfluoralkane
      metered dose inhaler (HFA MDI)). In a first step, the trial was performed in healthy subjects
      and - if no safety concerns arose - in a second step in patients with mild asthma who were
      sensitive to metacholine in a respective challenge test. Secondary objective: To explore the
      pharmacokinetics (PK) of BHT.
    


Intervention name(s): BHT 0.1%; BHT 0.5%; Placebo for RMT-B; Placebo for HFA-MDI
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Butylated Hydroxytoluene
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
The Effects of Intra Operative Hand Reflexology for Patients Receiving Out Patient Vein Surgery
Condition: Pain; Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      This randomised controlled trial aims to compare the effectiveness of hand reflexology
      received during office based vein surgery, under local anaesthetic on patient's reports of
      pain and anxiety, compared to usual standard care.
    

Detailed description: 
      The negative effects of anxiety and pain on surgical recovery are well documented. It is also
      accepted that distraction can be effective in pain reduction. This randomised controlled
      trial will explore the effect of intra operative hand reflexology on pain perception and
      anxiety during office-based surgery under local anaesthetic. Participants will be randomly
      allocated to either the experimental condition, in which they will receive a hand reflexology
      during treatment, or control condition in which they will receive usual standard care.
      Immediate and longer term outcomes will be explored.

      Eight weeks after surgery, participants will return to the clinic for a follow up
      appointment. While they are in the waiting area they will be asked to complete a short
      questionnaire to assess time taken to return to pre surgical levels of functioning, pain
      experienced in the first four weeks after surgery, severity of venous symptoms and
      satisfaction with treatment.
    

Intervention name(s): Hand Reflexology
Intervention type(s): Behavioral
Intervention description(s): The hand reflexology will begin in theatre, before the local anaesthetic is administered and will continue until the patient is ready to leave the operating theatre.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Randomised controlled trial; Pain; Anxiety; Ambulatory surgery; Hand massage; Local anaesthetic
Investigation of the Absorption, Metabolism, and Excretion and the Absolute Bioavailability of YH12852
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 1

Summary: 
      This study investigates the absorption, metabolism, and excretion and the absolute
      bioavailability of YH12852 in healthy male subjects
    

Detailed description: 
      Part 1 : Investigate the absorption metabolism, and excretion of YH12852 after single oral
      administration of YH12852 and 14C-labeled YH12852.

      Part 2

      : Investigate the absolute bioavailability of YH12852 after single oral administration of
      YH12852 followed by a single i.v. administration of 14C-labeled YH12852.
    

Intervention name(s): YH12852; 14C-labeled YH12852
Intervention type(s): Drug; Drug
Intervention description(s): YH12852 administration; 14C-labeled YH12852 administration
Intervention MeSH terms: YH12852
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Accelerated Mass Spectrometry; Microtracer; Microdose; hAME; Absolute bioavailability