bioihbjkbjnl/mcl2 huggingface dataset:
Outcomes of Transrenal Artery Perfusion Versus Transrenal Vein Perfusion Using LifePort for Deceased Donor Kidney Transplantation
Condition: Kidney Transplantation; Organ Preservation
MeSH terms: Death
Study type: Interventional

Summary: 
      The main objective of this study is to compare the outcomes of transrenal artery perfusion
      versus transrenal vein perfusion using LifePort for deceased donor kidney transplantation.
      Patients registered in the National Dialysis and Transplant Registry awaiting deceased donor
      kidney transplantation were included. Delayed graft function (DGF) or primary nonfunction
      (PNF) may occur after deceased donor kidney transplantation. Compared with static cold
      storage, the application of LifePort can significantly reduce the incidence of DGF and PNF in
      deceased donor kidney transplantation. Transrenal artery perfusion is currently the
      mainstream but confronts multiple renal arteries, resulted in prolonged cold ischemia time.
      Transrenal vein perfusion is expected to be a solution. However, whether the clinical
      outcomes of transrenal vein perfusion is inferior to transrenal artery perfusion remains
      unknown. In this study, values of urine volume and creatinine, incidence and duration of DGF,
      and incidence of PNF within 1 week after surgery are recorded and compared between the
      transrenal artery perfusion group and the transrenal vein perfusion group. Monthly eGFR and
      creatinine values, the incidence of acute rejection within 1 year after transplantation and
      1-year graft and patient survival are also recorded and compared.
    


Intervention name(s): LifePort transrenal artery perfusion; LifePort transrenal vein perfusion
Intervention type(s): Device; Device
Intervention description(s): transrenal artery perfusion group; transrenal vein perfusion group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
High Protein Intake in Critically Ill Ventilated Patients
Condition: Intensive Care Unit Syndrome
Study type: Observational [Patient Registry]

Summary: 
      This prospective interventional randomized control study was conducted on forty patients with
      respiratory failure; all patients were intubated and mechanically ventilated for at least
      three days. Twenty patients received high protein intake using whey protein, with daily
      follow-up of the blood sugar level, serum electrolytes, and chemistry. ICU outcome regarding
      food intolerance, 30-day mortality, length of MV and ICU-stay was recorded
    


Intervention name(s): Whey protein
Intervention type(s): Dietary Supplement
Intervention description(s): Patients were randomly divided into two groups: Group (A): Enteral feeding with normal protein intake ( 1.0 gm pin /kg/day ) Group (B): Enteral feeding with high protein intake ( 1.5- gm open /kg/day ) -Patient's- nonprotein- caloric intake was calculated according to REE :(25xactual body weight in kg ) and received it as follow : 1/2 the calculated amount of caloric intake in DAY 1 3/4 of the calculated amount of caloric intake in DAY 2
-Full calculated caloric amount in DAY 3
This regimen was followed long as the patient was tolerating the amount of feeding, and in case of intolerance:
The volume of feeding boluses was decreased or Increase the time interval between boluses or IV metoclopramide or erythromycin was given
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        adult mechanically ventilated patients
Caries-preventive Effect of a Dentifrice Containing 5,000 Ppm Fluoride in Orthodontic Patients
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 4

Summary: 
      AIM: To evaluate the efficacy of daily tooth brushing with high concentrated fluoride
      dentifrice on white spot lesion (WSL) formation in adolescents during treatment with fixed
      orthodontic appliances (FOA).

      The null hypothesis is that neither incidence nor severity of lesions would differ from a
      control group using standard fluoride dentifrice.

      SUBJECTS AND METHODS: 420 healthy consecutive 11-16 year-old patients referred to 4
      Orthodontic Specialist Clinics are randomized to use either a dentifrice containing 5.000 ppm
      fluoride or a regular dentifrice with 1.450 ppm sodium fluoride. To be eligible for
      inclusion, the patients are scheduled for bimaxillary treatment with FOA for an expected
      duration of at least 1 year. All are instructed to use 0.25 gram dentifrice and brush their
      teeth during 2 minutes twice daily during the entire period of treatment. Before bonding, and
      after polishing with a rubber cup and non-fluoride pumice paste, 3 digital photos of the
      maxillary incisors, canines and premolars are taken. At debonding, remaining composite
      material on the surfaces is removed with a slow rotating carbide bur followed by polishing
      with a rubber cup and pumice paste. A new series of frontal and lateral digital photos is
      thereafter exposed.

      The primary outcome measure is the incidence and severity of WSL as registered separately by
      two blinded experienced and calibrated clinicians according to a validated index. A random
      sample of 50 cases is re-assessed to check intra- and inter-examiner reliability. The
      intervention is indended run throughout the full duration of the orthodontic treatment,
      varying between 18 and 24 months.
    

Detailed description: 
      not desired
    

Intervention name(s): toothpaste containing 5,000 ppm fluoride; 1450 GCP
Intervention type(s): Other; Other
Intervention description(s): 1 cm tootpaste twice daily during 2 minutes; Twice gaily toothbrushing with normal adult toothpaste containing 1450 ppm F representing good clinical practice
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Primary purpose: Prevention
Keywords: caries; prevention; orthodontics; fixed appliances; adolescents
Effect of Cabergoline on Weight and Glucose Tolerance
Condition: Body Weight; Impaired Glucose Tolerance in Obese
MeSH terms: Glucose Intolerance; Body Weight
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is to determine the efficacy of cabergoline, a long-acting dopamine
      receptor agonist, on body weight and blood glucose in healthy obese adults.

      This is a randomized double-blind placebo controlled study. Twenty subjects each will be
      randomly assigned either placebo or cabergoline for 16 weeks.

      The effect of treatment on body weight and blood glucose and insulin levels will be compared
      in the treatment versus the placebo arm.
    


Intervention name(s): Cabergoline; placebo
Intervention type(s): Drug; Other
Intervention description(s): cabergoline 0.5 mg twice weekly; 1 pill twice weekly
Intervention MeSH terms: Cabergoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a first-in-human, randomized, double-blind, parallel-group, vehicle-controlled study
      to evaluate the efficacy, safety, tolerability, and PK of ATI-1777 solution following
      twice-daily applications to target areas of participants with moderate or severe atopic
      dermatitis (AD).
    

Detailed description: 
      Participants underwent screening evaluations to determine eligibility up to 30 days prior to
      randomization. Participants who meet all the entry criteria were randomized on Day 1 to
      active or vehicle treatment. Participants applied study drug (ATI-1777 topical solution 2.0%
      w/w or vehicle) twice daily for 4 weeks with weekly study visits and were to return 2 weeks
      after the last dose of study medication for a Post treatment Follow-up (PTFU) Visit.
    

Intervention name(s): ATI-1777; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): ATI-1777 topical solution 2.0% w/w; Vehicle topical solution containing no ATI-1777
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-blind, Vehicle-controlled, Parallel-group Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Yellow Pea Fractions and Short-term Food Intake, Subjective Appetite and Glycemic Response
Condition: Obesity; Type II Diabetes Mellitus; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      It is hypothesized that yellow pea protein and fiber will reduce short-term food intake,
      subjective appetite and glycemic response.
    

Detailed description: 
      A within-subject, randomized study was conducted. Each subject returned 5 times, 1 week
      apart, and received 1 of the 5 treatments per week. The 5 treatments were tomato soup with 10
      or 20 g of isolated yellow pea fibre or protein, or a control soup with no added pea
      fractions. Food intake was measured at an ad libitum pizza meal served 2 hours after
      treatment. Satiety and blood glucose (via finger prick) were measured throughout the
      treatment period.
    

Intervention name(s): yellow pea protein; yellow pea fiber; Control
Intervention type(s): Dietary Supplement; Other; Dietary Supplement
Intervention description(s): Served in a tomato soup; Served in a tomato soup; Served in a tomato soup
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Obesity; Food intake regulation; blood glucose regulation; protein; fiber; pulses; yellow peas
Coverage and Cost-of-Care (CC) Links- Financial Navigation Program
Condition: Financial Stress; Hematologic Cancer; Survivorship
MeSH terms: Hematologic Neoplasms; Financial Stress
Study type: Interventional

Summary: 
      This trial is a mixed-methods, non-randomized design guided by the Consolidated Framework for
      Implementation Research (CFIR) to develop, implement, and evaluate Coverage and Cost-of-Care
      Links (CC Links) -a novel financial navigation intervention for hematologic cancer survivors
      and their caregivers.
    

Detailed description: 
      The CC Links intervention included an oncology financial navigator who worked in the
      Hematology-Oncology Clinic. The navigator's functions included: screening for financial
      hardship to identify unmet financial needs (using the Comprehensive Score for Financial
      Toxicity (COST) and National Comprehensive Cancer Network's Distress Thermometer; initiating
      cost of care conversations; providing cost of care estimates; ensuring adequate health
      insurance coverage and assisting with applying for additional coverage; assisting with
      internal financial assistance program applications; connecting survivors/caregivers with
      disease specific resources and other external assistance programs; coordinating discharge
      planning; referring survivors to social workers and other staff/resources as needed; and,
      coordinating financial assistance services as survivors/caregivers transition between
      outpatient and inpatient settings.
    

Intervention name(s): CC Links
Intervention type(s): Other
Intervention description(s): The CC Links intervention is built on a platform of interdisciplinary team-based science, which ensured that the financial navigator worked closely with other members of the healthcare team including oncologists, nurses, transplant coordinators, social workers, and case managers, to help enhance financial hardship screening and connect survivors and caregivers with financial assistance services.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: financial navigation; quality of life; hardship; caregivers; financial toxicity
Ablation of Complex Fractionated Electrograms With or Without Additional Linear Lesions for Persistent Atrial Fibrillation
Condition: Atrial Fibrillation; Recurrence
MeSH terms: Atrial Fibrillation; Recurrence
Study type: Interventional

Summary: 
      While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for
      paroxysmal and persistent atrial fibrillation (AF), different additional ablation approaches
      are used for substrate modification: linear lesions, ablation of complex fractionated atrial
      electrograms (CFAE) or a combination of both. The aim of this study is to determine whether
      there is a difference in terms of freedom from arrhythmia recurrence between PVI with CFAE
      ablation in combination or not with linear lesions in patients with persistent AF.
    


Intervention name(s): PVI+CFAE+DCC; PVI, CFAE, anterior and roof line, DCC
Intervention type(s): Procedure; Procedure
Intervention description(s): pulmonary vein Isolation (PVI), CFAE for substrate modification and direct current cardioversion (DCC) if AF persists; PVI, CFAE ablation. If AF persists linear lesions (anterior and roof line), cardioversion if AF persists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atrial fibrillation; Recurrence; CFAE; linear ablation
Pharmacokinetic Study to Determine Time to Steady-state
Condition: Male Hypogonadism; Primary Hypogonadism; Secondary Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to confirm how long (i.e., how many days) it takes to reach
      steady-state when testosterone undecanoate is administered twice daily.
    

Detailed description: 
      Serum testosterone levels will be obtained in hypogonadal (serum testosterone <300 ng/dL)
      males receiving testosterone undecanoate capsules administered twice daily. Serum samples
      will be obtained consecutively in the morning on several days during one month of open-label
      treatment to confirm the time at which steady-state is reached.
    

Intervention name(s): Testosterone undecanoate
Intervention type(s): Drug
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cognitive Behavioral Therapy (CBT) for Latinos With Generalized Anxiety Disorder in the General Medical Sector
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this project is to implement culturally adapted Cognitive Behavioral Therapy
      (CBT) based interventions in general health settings that are delivered to reduce Generalized
      Anxiety Disorder (GAD) symptoms, increase levels of functioning, and improve health-related
      quality of life.
    

Detailed description: 
      This project seeks to lay the foundation for an effectiveness trial that will lead to the
      advancement of CBT based treatments for GAD among Spanish-speaking Latinos, particularly
      Puerto Ricans. This area of research is important in light of the limited treatment options
      currently available for Spanish-speakers with GAD and the long-term negative consequences of
      this condition. Participants in this study are recruited in general health settings. Patients
      meeting criteria for enrollment will be randomly assigned to receive either cognitive
      behavior based therapy or treatment as usual. Assessments for all participants will be
      collected at baseline, post-treatment, and at two months follow-up visits.
    

Intervention name(s): Cognitive behavior based therapy; Treatment as usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 15-20 individual psychotherapy sessions; Treatment as usual is an active comparator group in which patients are provided referrals to specialty mental health care services or can use any primary or specialty care services available to them in usual care.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Study to Assess the Effect of Renal Impairment on the Pharmacokinetics of CTP-543
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-dose, sequentially designed, single-period study to determine
      the effect of moderate renal impairment on the pharmacokinetics (PK) of CTP-543 and its major
      metabolites following administration of a single 12 mg oral dose of CTP-543.
    


Intervention name(s): CTP-543
Intervention type(s): Drug
Intervention description(s): Single 12 mg oral dose administered on Day 1
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: CTP-543
A Clinical Study to Assess the Safety and Effectiveness of Herbal Supplement in Adult Human Subjects.
Condition: Difficulty in Sleep Initiation
Study type: Interventional

Summary: 
      A proof of science/concept clinical study with single-arm, single-blind, to evaluate safety,
      efficacy and in-use tolerability study of Herbal Supplement in adult human subjects having
      difficulty in falling asleep.

      A total of up to 32 subject will be enrolled to get 30 completed subject in the study.
    

Detailed description: 
      A sufficient number of adult subjects with an age group of 18 - 65 years old will be
      recruited/enrolled.

      The potential subjects will be screened as per the inclusion & exclusion criteria only after
      obtaining written informed consent from the subjects. The subjects will be instructed to
      visit the facility as per the below visits.

        -  Visit 01 (Day -07): Screening within 7 days from Day 01

        -  Visit 02 (Day 01): Enrolment Day

        -  Visit 03 (Day 15): End of treatment

        -  Visit 04 (Day 30): Telephonic follow-up Subjects will be pre-screened by the screening
           department of NovoBliss Research. Subjects will be telephonically contacted by
           recruiting department prior to the enrolment visit. Subjects will be instructed during
           screening (prior to enrolment) have to fill up the sleep diary before enrolment.

      Assessment of safety and efficacy parameters will be done before test treatment usage on Day
      1, and will be compared with after test treatment usage on Day 15 (+2 Days) as listed-below.

        -  Leeds Sleep Evaluation Questionnaire (LSEQ)

        -  Clinical examination - Scoring Based

        -  Sleep diary (sleeping time, the time interval in getting sleep, sleep interruptions,
           wake-up time, naps during the day, feeling, irritability, total duration of sleep, sleep
           quality.

        -  Product perception questionnaires (Product's effectiveness, likeliness and overall
           satisfaction- Hedonic scale (0-9-point scale)

        -  Blood parameter (CBC, ESR, RBS, SGOT, SGPT, S. Creatinine) - Safety Labs
    

Intervention name(s): Zzowin Nutra Tablet
Intervention type(s): Drug
Intervention description(s): 1 Tablet daily half an hour before going to bed
Other intervention name(s): Herbal Supplement
Intervention model: Single Group Assignment
Intervention model description: Proof of science/concept, Single-arm, Single-blind
Masking: None (Open Label)
Primary purpose: Supportive Care
First in Human Study of AL-335; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C Genotype 1
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, placebo-controlled, 3-part study will assess the safety,
      tolerability, and pharmacokinetics of orally administered AL-335 in healthy volunteers (HV)
      and subjects with CHC infection.
    


Intervention name(s): AL-335 matching placebo; AL-335
Intervention type(s): Drug; Drug
Intervention MeSH terms: Adafosbuvir
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Hearing Loss and Complaint in Patients With Head and Neck Cancer Treated With Radiotherapy
Condition: Hearing Loss
MeSH terms: Head and Neck Neoplasms; Hearing Loss; Deafness
Study type: Observational

Summary: 
      Hypothesis: Treatment for head and neck tumors often involve methods that affect the auditory
      system and cause hearing loss. Neck dissection negatively impacts the lymphatic drainage,
      chemotherapy uses ototoxic drugs, radiotherapy affects blood flow and tissue radiation is
      toxic to the ear and may lead to hearing losses of various types and degrees.

      Objective: To investigate occurrences of hearing loss and complaints among patients with head
      and neck tumors who underwent radiotherapy.

      Study design: Prospective, case-control study. Setting: Tertiary care center hospital.

      Subjects and Methods: 282 subjects were evaluated, 141 with head and neck tumors and 141 as
      an age-matched control group. The controls had never undergone oncological treatment that put
      their hearing at risk. All subjects underwent audiological evaluation, including the HHIE
      questionnaire, pure tone audiometry, speech audiometry and immittance audiometry. The
      radiation dose received by the auditory system was calculated based on the percentage of the
      external auditory canal included in the radiation field.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study design: Prospective, case-control study. Setting: Tertiary care center hospital.
      
Keywords: hearing loss; head and neck cancer; radiotherapy; hearing complaint; Hearing loss due to the exposure of radiotherapy