bioihbjkbjnl/mcl2 huggingface dataset:
Randomized Control Trial of an Animal-Assisted Intervention With Adjudicated Youth
Condition: Conduct Disorder; Depression; Anxiety
MeSH terms: Conduct Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The project involves testing the efficacy of an animal-assisted intervention (AAI). The AAI
      consists of a 10-week program in which adjudicated adolescents train shelter dogs and will be
      compared to a dog walking control group matched for educational content and dog contact time.
      The investigators expect that the AAI will result in improved empathy skills and that dog
      attachment will explain these findings. The investigators also explore the extent to which
      the AAI will improve internalizing and externalizing symptoms in these adolescents.
    

Detailed description: 
      Adjudicated adolescents (i.e., teens who have committed criminal offenses and are
      incarcerated in juvenile detention centers) have deficits in emotion regulation, including
      empathy skills, and are at risk for a host of poor outcomes including repeat offenses,
      internalizing symptoms (e.g., depression, anxiety), externalizing symptoms (e.g., lying,
      truancy, fighting). Many of these problems stem from a lack of secure attachment to parents
      and peers. There is a need for novel and innovative programs to help these teens develop more
      secure attachments and better empathy skills to prevent poor outcomes. One type of
      intervention is animal-assisted interventions such as dog training programs. These programs
      appear to build empathy skills in at-risk youth, which may translate into better peer
      relations, less psychological distress, and less recidivism. The goal of this study is to
      test an existing animal-assisted intervention program that is already being used in juvenile
      detention centers to determine whether it is efficacious in improving adjudicated
      adolescents' empathy skills and psychological symptoms through building a secure attachment
      to the training dog.
    

Intervention name(s): Animal-assisted intervention
Intervention type(s): Behavioral
Intervention description(s): The experimental group will receive 10 weeks of classroom training and hands-on experience working with dogs to teach them basic obedience skills. Each participant will work with the same dog each week. The active control group will receive 10 weeks of classroom training and will walk a different dog each week but will not teach obedience skills to the dogs.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Animal-assisted intervention; adjudicated adolescents; empathy
Autologous CD34+ Hematopoietic Stem Cells Transduced ex Vivo With Elongation Factor 1 Alpha Shortened (EFS) Lentiviral Vector Encoding for the Human ADA Gene
Condition: ADA-SCID
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is to assess the safety and efficacy of autologous transplantation of
      hematopoietic stem cells (CD34+ cells) from the bone marrow (BM) of ADA-deficient SCID
      infants and children following human ADA cDNA transfer by the EFS-ADA lentiviral vector. The
      level of gene transfer in blood cells and immune function will be measured as endpoints.
    

Detailed description: 
      The study is open to twenty (20) infants and children diagnosed with ADA-deficient SCID who
      did not have a medically eligible, human leukocyte antigen (HLA)-identical sibling donor for
      bone marrow transplantation. The EFS-ADA lentiviral vector with the human ADA cDNA will be
      used to transduce autologous CD34+ cells from the bone marrow of these subjects. The subjects
      will receive 4 mg/kg busulfan prior to re-infusion of their gene-modified cells. Safety is
      the primary endpoint. During the follow-up phase, the investigators aim to determine whether
      the cells could engraft and produce mature cells that contain and express the corrected ADA
      gene in the absence of pegademase bovine (PEG-ADA) enzyme replacement therapy (ERT), which
      will be withheld at Day +30 following transplant. Efficacy studies to evaluate the level of
      immune reconstitution, will be performed in the first and second years of the study.
    

Intervention name(s): Infusion of autologous EFS-ADA LV CD34+ (OTL-101); busulfan; PEG-ADA ERT
Intervention type(s): Genetic; Drug; Drug
Intervention description(s): autologous EFS-ADA LV CD34+ cells (OTL-101) are infused intravenously; Busulfan is used for non-myeloablative conditioning; PEG-ADA ERT is discontinued at Day +30 (-3/+15 days) after successful engraftment
Other intervention name(s): OTL-101
Intervention MeSH terms: Busulfan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gene therapy; hematopoietic stem cell; ADA-SCID; lentiviral vector
The Effect and Mechanisms of the Second-meal Phenomenon in Type 2 Diabetic Patients
Condition: Type 2 Diabetes
Study type: Observational

Summary: 
      Second-meal phenomenon denotes the effect of a prior meal in decreasing the rise in blood
      glucose after a subsequent meal. This phenomenon occurs in normal subjects while it is not
      clear whether it is also observed in type 2 diabetic patients. This study aims to define
      whether the second-meal phenomenon occurs in type 2 diabetic patients. We will also seek for
      the mechanism.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        type 2 diabetic patients
      
Biospecimen description: 
      plasma, serum
Effectiveness of a Team-based Follow-up Program in General Practice Among People With Chronic Conditions
Condition: Diabetes Type 2; COPD
MeSH terms: Diabetes Mellitus, Type 2; Chronic Disease
Study type: Interventional

Summary: 
      The study will develop and evaluate the effectiveness of a team-based follow-up program in
      general practice (GP) among people with chronic conditions.
    

Detailed description: 
      The epidemic proportion of lifestyle related non-communicable diseases is a worldwide
      challenge and public health problem resulting in significant hospitalization rates, mortality
      and morbidity, and huge personal and societal costs. This project involves research for
      better public health and health outcomes acknowledging the need for improvements in the
      health-care services in the prevention of risks and harm and better risk-factor management.
      We will conduct a randomized control study in four GP practices with ≥3 GPs and ≥one nurse
      among 154 people at risk for developing Type 2 Diabetes Mellitus (T2DM) or manifest disease,
      and 154 people in the control group. Inclusion criteria are Diabetes Risc Calculator
      (FINDRISC) ≥ 15 or HbA1c ≥6,5 % or specific need for individualized follow up such as Body
      Mass Index (BMI) ≥ 30. In addition, we will conduct a feasibility study among 30 people with
      risk for Chronic Pulmonary disease (COPD) or manifest disease. The study has the following
      two objectives: 1) to evaluate the effectiveness of a team-based follow-up program among
      people with risk for T2DM or manifest T2DM with the use of Guided Self-Determination (GSD) as
      an empowerment approach for patients in general practice, 2) to test the feasibility and
      pilot a team-based follow-up program among people with risk for COPD or manifest COPD with
      the use of GSD as an empowerment approach for patients in general practice.
    

Intervention name(s): Guided Self-Determination; Standard care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Structured team-based consultations; Standard consultations
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Increased Calorie Intake to Reverse Energy Deficiency in Exercising Women: Impact on Bone and Menstrual Cyclicity
Condition: Menstrual Irregularity
MeSH terms: Menstruation Disturbances
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of increased food intake on the menstrual
      cycle and bone health in physically active women who have irregular or absent menstrual
      cycles. This study will examine whether a 12 month period of increased food intake will cause
      menstrual cycles to resume and help bones get stronger.
    

Detailed description: 
      Low levels of estrogen found in physically active, premenopausal women with irregular or
      absent menstrual periods is likely caused by insufficient energy (calorie) intake compared to
      energy expenditure. Premenopausal women with menstrual disturbances and amenorrhea suffer
      from reductions in bone mineral density, particularly in the lumbar spine. Bone loss observed
      in amenorrheic women may be serious enough to result in osteoporotic fractures, but is also
      associated with a high prevalence of stress fractures. Increased calorie intake should help
      improve energy status, menstrual status, and bone health.

      Comparison: Premenopausal women with irregular or absent menstrual periods will be assigned
      to either receive additional calories or serve as controls. A group of premenopausal women
      with normal menstrual periods will also be used for comparison.
    

Intervention name(s): EAMD+Calories
Intervention type(s): Behavioral
Intervention description(s): During the 12 month intervention, volunteers in the Increased calorie intake group will follow a modified dietary plan designed to achieve and maintain a target level of 20-30% above their previously determined baseline, in an effort to achieve a chronic energy surplus of +20-30% over their baseline energy requirements.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amenorrhea; Energy deficiency; Resting energy expenditure; Bone metabolism; Bone mineral density; Exercise
Variations in the DIO2 and MCT10 Genes and Effect of Triiodothyronine Treatment
Condition: Hypothyroidism
MeSH terms: Hypothyroidism
Study type: Observational

Summary: 
      Hypothesis: Variations in the deiodinase 2 gene and monocarboxylate transporter 10 gene is
      associated with improvement in quality of life after initiation of combination therapy with
      L-Thyroxine and Liothyronine in patients with persistent hypothyroid symptoms despite
      conventional L-thyroxine mono-therapy.

      Purpose: To re-test this hypothesis in patients with continued perceived effect of
      Liothyronine treatment at least one year after initiation in a patient population more
      representing of daily clinical practice. The study will help determine whether testing of
      specific gene variations might predict longtime effect of combination therapy.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients in this study have been diagnosed with hypothyroidism and have had persistent
        hypothyroid symptoms despite L-thyroxine mono-therapy. They have all been referred to the
        department of endocrinology and have been examined by a trained endocrinologist. All
        patients have at least one year before the study initiated combination therapy with
        L-thyroxine and Liothyronine.
A Drug-Drug Interaction Study to Assess the CYP1A2 and CYP3A4 Interaction Potential of TEV-56286 (anle138b)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this healthy volunteers drug-drug interaction study is to assess the CYP1A2
      and CYP3A4 perpetrator interaction potential and CYP1A2 victim potential of TEV-56286
      (anle138b).
    

Detailed description: 
      This a 2-part DDI study that will assess the CYP1A2 and CYP3A4 perpetrator interaction
      potential of TEV-56286 single dose and multiple dose, using caffeine and midazolam as
      substrates and CYP1A2 victim potential of TEV-56286 (anle138b) at steady state induction
      using fluvoxamine as inhibitor [1,2].The estimated time from screening until the follow-up
      visit is approximately up to 8 weeks for each subjects.
    

Intervention name(s): anle138b (TEV-56286); Fluvoxamine 100 mg QD for 5 days
Intervention type(s): Drug; Drug
Intervention description(s): Anle138b (TEV-56286) as perpetrator; Anle138b (TEV-56286) as victim
Other intervention name(s): Caffeine; Midazolam; Fluvoxamine; TEV-56286 150 mg QD for 14 days + 5 days of co-administation with fluvoxamine
Intervention MeSH terms: Midazolam; Fluvoxamine; Caffeine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Drug drug interaction study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anle138b (TEV-56286); alpha-Synuclein; Oligomer modulator; Multiple System Atrophy; Parkinson Disease; Alzheimer Disease; Neurodegenerative diseases; Tauopathies; Amyloid; Drug-drug interaction
A Phase 1 Dose Escalation Study to Evaluate Safety and Pharmacokinetics (PK) of VX-840 in Healthy Participants
Condition: APOL1-mediated Kidney Disease
MeSH terms: Kidney Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and PK of single and
      multiple ascending doses of VX-840 in healthy participants.
    

Detailed description: 
      This clinical trial information was submitted voluntarily under the applicable law and,
      therefore, certain submission deadlines may not apply. (That is, clinical trial information
      for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public
      Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by
      sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
    

Intervention name(s): VX-840; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Solution for oral administration.; Placebo matched to VX-840 for oral administration.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Hydrocortison Treatment on Angiotensin II and Angiotensin II Receptors in Patients With Septic Shock
Condition: Shock, Septic
MeSH terms: Shock, Septic; Shock
Study type: Observational

Summary: 
      This study aims to evaluate the role of angiotensin II, AT1, and AT2 on catecholomine
      responsive and catecholomine resistant septic shock, and the effect of hydrocortisone
      traetment on catecholomine resistant septic shock and angiotensin II, AT1, and
      AT2.Angiotensin II can be used as a biomarker of vasoplegia observed in refractory septic
      shock unresponsive to catecholamine. In these patients; therapeutic effect of hydrocortisone
      on hypotension was performed by decreasing AT 2 level, AT2 should be investigated as a
      therapeutic target in the treatment of vasoplegia-induced hypotension and SVRI measured by
      minimally invasive cardiac output method suggests that it can be used as a useful parameter
      in the diagnosis and follow-up of vasoplegia.
    

Detailed description: 
      This study will be enrolled 40 patients diagnosed with septic shock according to Sepsis 3
      criteria. The patients with septic shock who needed a noradrenaline infusion rate of up to
      0.5µg/kg/min to maintain MAP>65 mmHg will be classified as control group (n=20) and the ones
      who required a noradrenaline infusion rate above 0.5µg/kg will be classified as
      hydrocortisone group (n=20). Blood samples will be taken for analysis of plasma angiotensin
      II, AT1, AT2 levels at the time of diagnosis, one hour after and on the 3rd day of the bundle
      and the hydrocortisone treatment. Hemodynamic parameters simultaneously obtain by continuous
      minimal invasive cardiac output measurement method will record.
    

Intervention name(s): Drug Steroid
Intervention type(s): Drug
Intervention description(s): hydrocortisone injection
Other intervention name(s): hydrocortisone
Intervention MeSH terms: Hydrocortisone
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study was enrolled 40 patients diagnosed with septic shock according to Sepsis 3
        criteria.
      
Biospecimen description: 
      blood samples
    
Keywords: Shock, Septic; hydrocortisone; angiotensin II
Biomagnetic Characterization of Gastric Dysrhythmias:Study 2
Condition: Ischemia
MeSH terms: Arrhythmias, Cardiac; Ischemia
Study type: Observational

Summary: 
      The purpose of this study is to use the Squid magnetometer (Superconducting QUantum
      Interference Device) to help diagnose electrical and mechanical abnormalities of the stomach
      and intestines.
    

Detailed description: 
      The Squid magnetometer is a non-invasive investigational device that measures the electrical
      activity in the smooth muscle of the intestines. Volunteers with normal bowel activity, those
      with gastric problems, and diabetics with gastric problems will be studied under the SQuid to
      determine normal and abnormal activity. Diabetics with an abnormal gastric emptying study
      will be asked to participate.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Primary Care clinic
      
Keywords: Blood supply; Mesentery
SF2a-TT15 Conjugate Vaccine in Healthy Adult Volunteers
Condition: Shigellosis; Bacillary Dysentery
MeSH terms: Dysentery, Bacillary; Dysentery
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a first-in-human, single-center, single-blinded, observer-masked randomized, dose
      escalation (two doses), placebo-controlled study in healthy volunteers.
    

Detailed description: 
      Subjects will be assigned to one of two cohorts.

        1. Cohort 1 will receive the lower dose of 2 μg vaccine (with or without alum adjuvant) or
           matching placebo.

        2. Cohort 2 will receive the higher dose of 10 μg vaccine (with or without alum adjuvant)
           or matching placebo.

      Eligible subjects will be randomized to receive the 2 μg dose or 10 µg without or with alum
      or matching placebo, at a ratio of 3:1, as three single IM injections. There will be an
      interval of 28(±3) days) between each treatment.

      The study will be conducted in a stepwise approach in which a "Pioneer" Group of 2 subjects
      (one receiving the active vaccine and one receiving the matching placebo) will receive the
      first injection. These subjects will remain in-house for a 24-hours medical observation after
      the first injection (not required in the subsequent injections) Once it has been established
      that there are no safety concerns in the non-adjuvanted "Pioneer" Groups (and after no less
      than 48 hrs), the next "Pioneer" group (one subject receiving adjuvanted 2 μg vaccine and one
      receiving the matching alum placebo) will be injected.

      If no safety concerns are raised in this group also, after no less than 48 hrs, the rest of
      the subjects may receive the first injection.
    

Intervention name(s): SF2a-TT15 vaccine; SF2a-TT15 vaccine + adjuvant; Placebo; Placebo + adjuvant
Intervention type(s): Biological; Biological; Biological; Biological
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Phase I; conjugate vaccine; Shigella flexneri 2a; safety; Immunogenicity; Healthy adults
Antibacterial Effectiveness of Two Root Canal Irrigants
Condition: Periapical Periodontitis
MeSH terms: Periodontitis; Periapical Periodontitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this randomized clinical trial is to compare the antibacterial effects of 1%
      sodium hypochlorite (NaOCl) and 2% chlorhexidine gluconate (CHX) during retreatment of teeth
      with apical periodontitis (AP).
    

Detailed description: 
      Root canal-treated teeth with AP were randomly distributed in two groups according to the
      irrigant used. After removal of the previous filling material, bacteriological samples were
      taken from the canals before (S1) and after chemomechanical preparation using either NaOCl or
      CHX (S2), and after calcium hydroxide medication for 2-3 weeks (S3). 16S rRNA gene-based
      real-time qPCR was performed to detect and quantify total bacteria, Streptococcus species and
      Enterococcus faecalis.
    

Intervention name(s): Retreatment of root-filled teeth with infection
Intervention type(s): Procedure
Intervention description(s): Root-filled teeth with infection are being treated with either 1% NaOCl or 2% CHX as disinfection irrigation solution.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: endodontic retreatment; sodium hypochlorite; chlorhexidine; calcium hydroxide; Retreatment
Multiclear Treatment for Striae Distensae - A Pilot Study
Condition: Striae Distensae
MeSH terms: Striae Distensae
Study type: Interventional
Phase: Phase 2

Summary: 
      Striae distensae is a common skin condition that rarely causes significant medical problems.
      However, it often results in a considerable amount of distress to those with the condition.
      Various modalities of treatments have been used for striae distensae but few have led to
      satisfactory results.

      More recently, newer techniques such as pulsed dye laser and radiofrequency devices have been
      used with modest results. There is still, however, paucity of data using light therapy for
      the treatment of this condition. Blue light therapy using the Multiclear device has been used
      successfully in the treatment of acne. In contrast, there is little data to suggest its use
      in the management of striae distensae.

      We aim to study the effects of blue light on the treatment of striae distensae and whether
      this can be used safely to manage this condition.
    

Detailed description: 
      Patients will receive twice weekly blue light treatment with the Multiclear device. The first
      treatment dose will be 75mJ/cm2 ( Minimum Effective Dose;MED) for all patients. If no
      erythema develops, the subsequent treatment dose can be increased by 0.5 MED. If mild to
      moderate erythema develops, the same dose (i.e. 1 MED) will be used.If severe erythema/
      blisters develop, treatment will be stopped and the patient wil be invited one week later and
      treatment will be offered at 50% of the last dose.

      During the first consultation, patients will be assessed for the presence of striae distensae
      (SD). Duration and previous treatments of SD will be recorded. The width of the widest striae
      and the length of the longest straie will be measured at baseline and after 2 months of
      treatment. Photographs will be taken at baseline and post treatment. These will be evaluated
      by dermatologists who will be blinded (i.e. details of which photographs are pre or post
      treatment will not be given). Subjective scores will be used (Very good to excellent; >75%,
      Good; 51-75%, Moderate; 26-50%, Minimal to no improvement; <25%) Participants will also be
      given a feedback form to rate any improvements noted and any side effects experienced.
    

Intervention name(s): Administration of light therapy - measurement of results before and after therapy
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: striae distensiae