bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of Single Port Laparoscopic Appendectomy in Acute Appendicitis
Condition: Appendicitis
MeSH terms: Appendicitis
Study type: Interventional

Summary: 
      The aim of this study is to investigate the safety and efficacy of single port laparoscopic
      appendectomy compared with conventional laparoscopic appendectomy in adults with acute
      appendicitis.
    

Detailed description: 
      Laparoscopic appendectomy improved the postoperative functional outcomes in the treatment of
      acute appendectomy. In addition, recently single port laparoscopic surgery was introduced in
      the laparoscopy-dedicated center. When compared with conventional 3 port laparoscopic
      appendectomy, single port laparoscopic appendectomy was expected to be less painful, more
      rapid recovery of bowel function, and better cosmetic. In this prospective randomized trial,
      we tried to investigate the superiority of this new technique in adult patients with acute
      appendectomy.
    

Intervention name(s): Single port laparoscopic appendectomy; 3 port laparoscopic appendectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Single port through the transumbilical 2-cm incision; 3 trocars was inserted in infraumbilical, left lower quadrant, and suprapubic area
Other intervention name(s): single port laparoscopic surgery; conventional laparoscopic appendectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Vortioxetine (Lu AA21004) in the Prevention of Relapse of Major Depressive Episodes
Condition: Major Depressive Disorder
MeSH terms: Recurrence; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy of Vortioxetine in the prevention of relapse of major
      depressive episodes in patients who responded to open-label treatment with Vortioxetine.
    


Intervention name(s): Placebo; Vortioxetine (Lu AA21004)
Intervention type(s): Drug; Drug
Intervention description(s): capsules, daily, orally; encapsulated tablets, daily, orally
Other intervention name(s): Brintellix
Intervention MeSH terms: Vortioxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Relapse prevention; Antidepressants; Placebo-controlled; Double-blind; Multicentre study
BCG and Plasma Amyloid in Non-Demented Adults
Condition: Alzheimer Disease, Late Onset
MeSH terms: Alzheimer Disease; Late Onset Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      BCG vaccination, the most widely used vaccination in the world, is used to reduce risk of
      tuberculosis infection; it is used for other mycobacterial infections as well, benefiting
      leprosy and Buruli ulcer. BCG has "heterologous" effects that aids in an array of
      non-mycobacterial and viral infections as well as bladder cancer. It is the heterologous
      effect, sometimes called the "off-target" effect that may offer benefit in Alzheimer's
      disease. Population studies and studies of adults receiving BCG show a lessened risk of
      Alzheimer's disease. The study will see if BCG vaccination will alter a plasma test for
      amyloid, a biomarker for cerebral amyloid.
    

Detailed description: 
      Alzheimer's disease (AD) is commonly regarded as Alzheimer's dementia. It is now understood
      that changes in the brain that result in late-onset AD dementia start years or even decades
      prior to clinical dementia. Biomarkers aid in diagnosing AD however, currently approved
      biomarkers have drawbacks as they are invasive and expensive. The two most commonly used
      biomarkers are amyloid PET scan and spinal tap for amyloid and tau. A new plasma amyloid test
      has received "Breakthrough Device Designation" from the US-FDA. As an investigational tool,
      this blood test for amyloid peptides 42/40 levels accurately predicts brain amyloidosis in
      cognitively normal individuals. In the past 100 years, four billion doses of BCG vaccination
      have been given for tuberculosis prevention. A favorable effect with BCG for non-tuberculous
      mycobacteria is also recognized in cervical lymphadeniits, leprosy and Buruli's ulcer.
      Recently, BCG has found favorable use in autoimmune diseases type 1 diabetes (T1D) and
      multiple sclerosis (MS); moreover, a protective role by BCG for Alzheimer's disease has been
      described. Adult exposure to BCG lessened the risk of AD by four-fold. This is an
      interventional pilot study to test 50 non-demented adults measuring their plasma amyloid
      42/40 level prior to BCG prime/boost followed with the same plasma amyloid testing 9 months
      after vaccination. Sub-clinical CMV infection is felt to drive immune senescence and increase
      the risk of AD; we will test for CMV antibodies and we will measure lymphocyte phenotype
      prior to BCG and at study end to look for an immune-modulating effect on this indicator of
      immunosenescence.
    

Intervention name(s): Bacillus of Calmette and Guerin (BCG)
Intervention type(s): Biological
Intervention description(s): Prime and boost vaccination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Alzheimer's disease; biomarker; BCG; plasma amyloid; peptides 42/40; heterologous effect; immune risk profile; CMV; HHV5; immunosenescence
Teen Adherence in KidnEy Transplant, Improving Tracking To Optimize Outcomes (Stage 1)
Condition: Medication Adherence
Study type: Observational

Summary: 
      The overall goal of the Teen Adherence in KidnEy transplant Improving Tracking TO Optimize
      Outcomes (TAKE-IT TOO) study is to adapt the successful TAKE-IT intervention, aimed at
      improving medication adherence in adolescent kidney transplant, for use in 'real world'
      clinical care. The specific aims of Stage 1 of this study are: (1) To understand the needs
      and preferences of stakeholders (kidney transplant recipients, parents, and healthcare
      professionals (HCP)) in order to optimize the TAKE-IT intervention for 'real world' use.
    

Detailed description: 
      TAKE-IT TOO is a prospective, 3-stage, sequential study using user-centered design techniques
      throughout. This entry describes Stage 1of TAKE-IT TOO. In Stage 1 we will conduct focus
      groups (FG) to gather data about the needs and preferences of stakeholders to inform
      adaptation of the Teen Adherence in Kidney transplant Effectiveness of Intervention Trial
      (TAKE-IT) intervention and features of a novel e-pillbox and adherence-tracking website. The
      protocols for Stages 2 and 3 will be submitted separately.
    

Intervention name(s): Focus Group
Intervention type(s): Other
Intervention description(s): Concurrently at each site, an experienced facilitator, having no direct affiliation with the clinical team, will use standardized stakeholder-specific, semi-structured scripts (designed with patient and parent collaborators) to conduct the patient, parent, and HCP focus groups. The TAKE-IT intervention will be described, and Simplemed e-pillbox shown, to all focus groups. Questions posed to the patient and parent focus groups will focus on 2 themes: the intervention and electronic monitoring. Example stakeholder-specific scripts to guide the discussions are appended. Each focus group will last ~90 min. and be audio-recorded. An observer will take field notes.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Representative groups of stakeholders (patients, parents and HCP) will be recruited from
        renal transplant centers representing two healthcare systems and a variety of program
        sizes: 3 in the United States (UPMC [which includes both adult and pediatric programs],
        Seattle Children's Hospital and St. Louis Children's Hospital), and 5 in Canada (MUHC,
        Ste-Justine Hospital (HSJ), Centre Hospitalier de l'Université de Montréal (CHUM),
        Vancouver's British Columbia Children's Hospital, and Toronto's Hospital for Sick
        Children).
      
Keywords: Kidney Transplantation
Bioequivalence of Two Liraglutide Formulations in Healthy Volunteers
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of the
      phase 3a formulation of liraglutide (formulation 4) and the liraglutide formulation planned
      for phase 3b trials (final formulation 4).
    


Intervention name(s): liraglutide
Intervention type(s): Drug
Intervention description(s): Two single doses of 0.72 mg liraglutide administered subcutaneously on two different dosing occasions separated by a wash-out period
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Antiretroviral Treatment Outcomes in HIV-HBV Co-infected Patients in Southern Africa
Condition: Hepatitis B Virus; HIV; Antiretroviral Therapy; Africa; Liver Fibrosis; Alcohol Use Disorder
MeSH terms: Hepatitis B; Hepatitis; Liver Cirrhosis; Alcoholism
Study type: Observational

Summary: 
      This is a prospective HIV cohort that aims to establish causes of liver disease among
      HIV-infected individuals in Zambia, including viral hepatitis and alcohol.
    

Detailed description: 
      The study will take place during routinely scheduled ART visits as per Ministry of Health
      guidelines. Routinely collected programmatic data will be used to assess general HIV outcomes
      (CD4 response, loss to follow-up, death) as well as collecting study specific data (hepatitis
      testing, questionnaire regarding risk factors for hepatitis/liver disease, and non-invasive
      liver scan) to address other aims. The study will be implemented at two sites in Southern
      Africa (Zambia and Mozambique) with a total enrollment across all sites of 1,900
      participants. The Zambia site will only enroll 900.
    

Intervention name(s): Standard of care
Intervention type(s): Other
Intervention description(s): routine standard of care per Ministry of Health protocol including blood draws and examinations.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Enrollment of 1,900 consecutive patients starting ART (900 in Zambia and 1,000 in
        Mozambique) is planned.
      
Biospecimen description: 
      Specimen storage is optional and participants will provide additional informed consent. The
      laboratory will store leftover blood specimens for up to 5 years for hepatitis related
      serologic, immunological, and virologic studies pending availability of funding. Use of
      specimens for any tests outside the realm of the goals and objectives of this study will
      require additional approval by the Zambian IRB.
    
Keywords: antiretroviral therapy; Hepatitis C virus
A Study to Compare the PK, PD and Safety and Tolerability of a SC With an IV Formulation of ARGX-113 in Healthy Male Subjects
Condition: Bioavailability Study
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is a Randomized, Open-label, Parallel Group Study to Compare the Pharmacokinetics,
      Pharmacodynamics and Safety and Tolerability of a Subcutaneous Formulation With an
      Intravenous Formulation of ARGX-113 in Healthy Male Subjects
    


Intervention name(s): ARGX-113
Intervention type(s): Drug
Intervention description(s): intravenous or subcutaneous administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Taste and Smell Impairment in Critically Ill COVID-19 Patients
Condition: Smell Disorder; Taste Disorders; Coronavirus Infection
MeSH terms: Coronavirus Infections; Taste Disorders; Olfaction Disorders
Study type: Observational [Patient Registry]

Summary: 
      Evaluating the smell and taste perceptions of patients hospitalized in the intensive care
      unit with suspicion of Coronavirus disease-19 diagnosis with a survey study
    

Detailed description: 
      Patients who were treated in the intensive care unit of Şişli Hamidiye Etfal Training and
      Research Hospital with the diagnosis of Coronavirus disease-19 will be determined by scanning
      the hospital registry system. It was planned that patients discharged from the intensive care
      unit would be called by phone and their complaints about smell and taste disorders were
      evaluated with a questionnaire.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients between the ages of 18-80, who were treated in the intensive care unit with the
        diagnosis of Coronavirus disease-19 and were discharged
      
Keywords: Coronavirus disease-19; anosmia; hyposmia; dysgeusia
A First Time in Man, Study to Assess the Safety of AZD8329 After Single Ascending Oral Doses
Condition: Healthy Men
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective for this study is to assess the safety and tolerability of AZD8329 when
      given as a single dose in increasing dose strength, and also to identify the highest
      tolerated dose for future studies.
    


Intervention name(s): AZD8329; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral solution, single ascending doses; Oral solution, placebo
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: First time in man; Safety study; AZD8329
The Effectiveness of the Use of Oxygen Reserve Index in Preventing Hyperoxia in the Intensive Care Unit.
Condition: Hyperoxia; Complication; Mechanical Ventilation Complication
MeSH terms: Hyperoxia
Study type: Interventional

Summary: 
      Oxygen therapy is the most common treatment modality for patients with hypoxemia in intensive
      care units, but target values for normoxemia are not clearly defined. Therefore, iatrogenic
      hyperoxemia is a very common situation. In intensive care units, FiO2 is usually adjusted
      according to hypoxia and hyperoxia is ignored in patients under mechanical ventilator
      support. Even though there are many side effects reported related to hyperoxemia and
      hyperoxemia is shown to be related to worse outcome than expected; clinicians still observe
      hyperoxemia frequently.

      Continuous ORi monitoring can be used for detecting and preventing hyperoxia. The ability to
      perform FiO2 titration with ORi may be an appropriate monitoring management to prevent the
      harmful effects of hyperoxia. In this study, it was aimed to investigate the effectiveness of
      ORi-guided FiO2 titration in preventing hyperoxia in patients undergoing mechanical
      ventilation in the intensive care unit and to determine the incidence of hyperoxia.
    

Detailed description: 
      In intensive care units, FiO2 is usually adjusted according to hypoxia and hyperoxia is
      ignored in patients under mechanical ventilator support. Even though there are many side
      effects reported related to hyperoxemia and hyperoxemia is shown to be related to worse
      outcome than expected; clinicians still observe hyperoxemia frequently.

      Oxygen reserve index (ORi™) (Masimo Corp., Irvine, USA) can guide clinicians in detection of
      hyperoxia. ORi is a parameter which can evaluate partial pressure of oxygen (PaO2) rating
      from 0 to 1. There are growing evidences in ORi that it might be helpful to reduce hyperoxia
      in general anesthesia. Continuous ORi monitoring can be used for detecting and preventing
      hyperoxia. The ability to perform FiO2 titration with ORi may be an appropriate monitoring
      management to prevent the harmful effects of hyperoxia.

      In this study, it was aimed to investigate the effectiveness of ORi-guided FiO2 titration in
      preventing hyperoxia in patients undergoing mechanical ventilation in the intensive care unit
      and to determine the incidence of hyperoxia.
    

Intervention name(s): Titration of fraction of inspired oxygen (FiO2) guided by ORI and oxygen saturation
Intervention type(s): Procedure
Intervention description(s): FiO2 will be titrated by reducing 10% if Ori>0.01 and oxygen saturation ≥ 98% until Ori is 0.00.
FiO2 will not be changed if Ori is 0.00 and %95<oxygen saturation≤%98 FiO2 will be increased by 10% if oxygen saturation <95 or PaO2<60 mmHg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Hyperoxia; Fraction of inspired oxygen; Intensive care unit
Effect of Kinesio Taping on Muscle Strength in Lower Trapezius
Condition: Shoulder Pain; Muscle Weakness
MeSH terms: Shoulder Pain; Muscle Weakness
Study type: Interventional

Summary: 
      The purpose of this project is to investigate the effect of Kinesio tape on muscle strength
      of the lower trapezius in people with shoulder symptoms and decreased muscle strength in the
      lower trapezius - a randomized controlled trial.
    

Detailed description: 
      The aim of the study is to investigate the effect of recoil tape with 0-30% tension, by using
      one application of Kinesio tape over the muscle fibers of the lower trapezius from its origin
      to its insertion. The participants will be divided into intervention group (taping) and
      control group (no intervention). Muscle strength test will be performed before and
      immediately after taping (20-30 minutes) for both groups using hand-held dynamometer
      measurements (MicroFET 3).

      Work is based on the following hypothesis: "Kinesio taping using recoil taping provides
      increased isometric muscle strength in lower trapezius immediately after application".
    

Intervention name(s): Kinesio tape
Intervention type(s): Other
Intervention description(s): Application of one Kinesio tape with 0-30 % tension over the muscle fibers of the lower trapezius in a stretched position. The tape can be divided into one, two or three tails to cover the whole muscle from origin to insertion
Other intervention name(s): Kinesio taping; Kinesio tex tape
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lower trapezius; Kinesio taping
Safety and Pharmacokinetics of Alpha-1 Proteinase Inhibitor in Subjects With Alpha1-Antitrypsin Deficiency
Condition: Emphysema; Alpha 1-antitrypsin Deficiency (AATD)
MeSH terms: Alpha 1-Antitrypsin Deficiency; Pulmonary Emphysema; Emphysema
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to assess the safety and pharmacokinetics of weekly infusions of 120 mg/kg of
      Prolastin-C (alpha1-proteinase inhibitor [alpha1-PI] [Human]), compared to weekly infusions
      of 60 mg/kg of Prolastin-C in patients with alpha 1-antitrypsin deficiency (AATD).
    

Detailed description: 
      The question of whether higher doses of alpha1-PI (>60 mg/kg) are able to provide better
      protection to patients with alpha 1-antitrypsin deficiency is currently unknown. As a first
      step to address this question, the present study has been undertaken. This is a multi-center,
      randomized, double-blind, crossover study to assess the safety and pharmacokinetics of weekly
      infusions of 120 mg/kg of Prolastin-C, compared to weekly infusions of 60 mg/kg of
      Prolastin-C in patients with alpha 1-antitrypsin deficiency. This study is a crossover design
      with 2 treatment sequences:

      Treatment Sequence 1: 60 mg/kg weekly infusion of Prolastin-C for 8 weeks followed by 120
      mg/kg weekly infusion of Prolastin-C for 8 weeks (starting at Week 1) (total of 16 treatment
      weeks)

      Treatment Sequence 2: 120 mg/kg weekly infusion of Prolastin-C for 8 weeks followed by 60
      mg/kg weekly infusion of Prolastin-C for 8 weeks (starting at Week 11) (total of 16 treatment
      weeks)

      Approximately 15 subjects are planned to be entered into each treatment sequence.

      At Weeks 8 to 11 and Weeks 18 to 21, a total of 15 serial blood samples for each subject will
      be drawn for pharmacokinetic analysis. The expected duration of the study subject's
      participation will be approximately 25 weeks (which includes a 3-Week Screening Phase, 2-Week
      Washout Period [between different alpha-1 PI treatment doses], and a 4-Week Follow-up
      Period). The following safety parameters will be assessed: adverse events, pulmonary
      exacerbations, vital signs, pulmonary function tests, and clinical laboratory tests.
    

Intervention name(s): Prolastin-C, 60 mg/kg; Prolastin-C, 120 mg/kg
Intervention type(s): Biological; Biological
Intervention description(s): 60 mg/kg weekly infusion of Prolastin-C for 8 weeks; 120 mg/kg weekly infusion of Prolastin-C for 8 weeks
Other intervention name(s): Alpha1-Proteinase Inhibitor; Alpha1-Proteinase Inhibitor (Human), Modified Process; Alpha-1 MP; Alpha1-Proteinase Inhibitor; Alpha1-Proteinase Inhibitor (Human), Modified Process; Alpha-1 MP
Intervention MeSH terms: Protease Inhibitors; Alpha 1-Antitrypsin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: emphysema; alpha 1-antitrypsin; alpha 1-antitrypsin deficiency (AATD); alpha 1-proteinase inhibitor (Alpha-1 PI)
Neuromodulation in Professional Dancers
Condition: Rehabilitation; Sports Physical Therapy; Sport Performance; Dance
Study type: Interventional

Summary: 
      Tendinopathy of the flexor hallucis longus (FHL), colloquially referred to as "dancer's
      tendinitis," is a common condition in dancers and attributed to high demand on this muscle in
      positions of extreme ankle plantarflexion and metatarsophalangeal (MTP) flexion and
      extension. Tradicional conservative treatment includes rest from pain-inducing activities
      including pointe work and jumping, physical therapy a focusing on movilization of the joints
      of the first ray and subtalar joint, and antiinflamatory medications. Unfortunately, dancer
      frecuently do not follow recommendations to rest due to the competitive nature of the field.
      Those who do not respond to conservative treatment undergo more serious interventions
      including steroid injections or surgery, each with additional risks and recovery time. To
      develop experimental protocols aimed at prevention and nonsurgical interventions are needed.
      Therefore, the aim of this study was To investigate the effects of one shot of low-frequency
      percutaneous electrical nerve stimulation (PENS) vs. one shot of transcutaneous electrical
      nerve stimulation (TENS) in performance of the Flexor Hallucis Longus muscle in young
      dancers.
    


Intervention name(s): PENS; TENS
Intervention type(s): Other; Other
Intervention description(s): This intervention consisted in the application of an asymmetric biphasic rectangular current of 150 microseconds and 10 Hz using a specifically developed medically certified device (Physio Invasive, Enraf Nonius, Prim, SPAIN). This is an invasive intervention by ultrasound and needles.; This intervention consisted in the application of an asymmetric biphasic rectangular current of 150 microseconds and 10 Hz using a specifically developed medically certified device (Physio Invasive, Enraf Nonius, Prim, SPAIN). This is a non-invasive intervention by self-adhesive electrodes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment