bioihbjkbjnl/mcl2 huggingface dataset:
Short-term Outcome After Ventral Hernia Repair
Condition: Short-term Outcome After Ventral Hernia Repair
MeSH terms: Hernia; Hernia, Ventral
Study type: Observational

Summary: 
      Hernia repair in sublay technique is widely accepted for ventral hernias, as it appears to be
      advantageous in terms of complication and recurrence rates. Recently, self-gripping meshes
      are increasingly used for hernia repair with retromuscular mesh positioning. However,
      real-life data on the safe use in that specific indication are still lacking. Therefore, this
      study evaluated short-term postoperative outcome of self-gripping versus conventional
      non-self-gripping meshes in sublay hernia repair.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        A retrospective single-centre cohort study was performed for the time period of January
        2011 to July 2018. All patients, receiving a ventral hernia repair (including incisional,
        umbilical or epigastric hernias) in Rives-Stoppa retromuscular mesh placement technique
        (sublay), were included into the final analysis.
Study of NGM395 in Adult Participants
Condition: Obesity; NAFLD
MeSH terms: Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Study of NGM395 in adult participants.
    


Intervention name(s): NGM395; NGM395; NGM395; NGM395; NGM395; NGM395; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Other
Intervention description(s): NGM395 Dose 1; NGM395 Dose 2; NGM395 Dose 3; NGM395 Dose 4; NGM395 Dose 5; NGM395 Dose 6; Placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Assess the Immunogenicity and Safety of GSK's Investigational Vaccine (GSK3277511A) When Given to Healthy Smokers and Ex-smokers After Administration of Shingrix Vaccine
Condition: Respiratory Disorders
MeSH terms: Respiration Disorders; Respiratory Tract Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will provide information regarding the sequential administration of two vaccines
      adjuvanted with AS01.

      The aim of this study is to understand immunogenicity and safety of NTHi-Mcat vaccine when
      administered sequentially after Shingrix vaccine and to compare to the immunogenicity of
      NTHi-Mcat vaccine administered alone. This study will also provide information regarding
      whether a specific time period is required between the administration of these two different
      vaccines containing the same adjuvant- AS01 components.

      The population of this study will include healthy smokers and ex-smokers of 50 to 80 years of
      age which will be used as a proxy for the COPD population.
    


Intervention name(s): GSK's investigational non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) multi-antigen vaccine (GSK3277511A) adjuvanted with AS01E; Shingrix GSK's lyophilized formulation of the herpes zoster (HZ) vaccine (GSK1437173A)
Intervention type(s): Biological; Biological
Intervention description(s): 2 doses of the investigational NTHi-Mcat vaccine will be administered 2 months apart to all subjects in all the groups. The vaccine will be given intramuscularly (IM) in the upper deltoid of non-dominant arm; 2 doses of the Shingrix vaccine will be administered at days 1 and 61 to all subjects in groups Sh_NTHi-Mcat_1, 3 and 6. The vaccine will be given intramuscularly (IM) in the upper deltoid of the non-dominant arm
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Immunogenicity; Chronic obstructive pulmonary disease (COPD); Non-typeable Haemophilus influenza; Moraxella catarrhalis; Shingrix; Herpes Zoster; Adjuvanted vaccines; Safety
The Safety, Tolerability and Pharmacokinetic Study of Yimitasvir in Healthy Adults Subjects
Condition: Chronic Hepatitis c
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The Safety, Tolerability and Pharmacokinetic Study of Chronic Hepatitis C Treatment Drug
      Yimitasvir in Healthy Adults Subjects.
    

Detailed description: 
      This was a Randomized，Double-blind, Placebo-controlled, Single Ascending Dose, Single-center
      Study to Assess the Safety, Tolerability and Pharmacokinetic of Yimitasvir in Healthy Adults
      Subjects

      A total of 56 healthy subjects were divided into 7 groups, with each group consisting of 8
      subjects. Six of the subjects received the investigational drug, and two received placebo.
      All of the subjects received a single dose.
    

Intervention name(s): yimitasvir; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsule administered orally once daily; Matching Placebo Capsule
Other intervention name(s): DAG181; DAG181 placebo
Intervention MeSH terms: Yimitasvir
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate the Effect of Food Intake on the Plasma Concentration Changes of Quetiapine After Oral Administration of FK949E in Healthy Volunteers
Condition: Healthy; Plasma Concentration Change of Quetiapine
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to evaluate the effect of food on the plasma concentration changes of quetiapine
      after oral administration of FK949E (extended release formulation of quetiapine) in healthy
      male subjects.
    

Detailed description: 
      This is a 3-way cross-over study.
    

Intervention name(s): FK949E
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): extended release formulation of quetiapine
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: FK949E; Quetiapine; Antipsychotic
Heart Transplant Patients, Health Status and Physical Activity
Condition: Disease, Chronic
MeSH terms: Chronic Disease
Study type: Observational

Summary: 
      The aim of this cross-sectional observational study is (1) to assess the health status of a
      group of heart transplant patients and their level of physical activity, (2) and to compare
      the health status of a group of heart transplant patients with different levels of physical
      activity, with a group of healthy people classified as sedentary (due to their level of
      physical activity).
    


Intervention name(s): Diagnostic tests
Intervention type(s): Diagnostic Test
Intervention description(s): No intervention will be carried out. Participants of the whole groups will be underwent the same tests.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Active and sedentary heart transplant patients and sedentary healthy people.
Enhanced Recovery After Surgery in Laparoscopic Sleeve Gastrectomy
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      While laparoscopic sleeve gastrectomy (LSG) has become the most commonly performed bariatric
      surgery procedure in the US and worldwide, it is associated with significant postoperative
      nausea and vomiting (PONV), which can lead to patient readmission for rehydration and symptom
      control. Enhanced recovery after surgery (ERAS) is an approach that aligns the practice of
      anesthesia with the care given by the surgical team before, during, and after surgery. A
      number of prospective series, retrospective analyses and one randomized clinical trial of
      ERAS use in bariatric patients support the idea that ERAS in this population is feasible,
      effective and safe and that it is associated with shorter lengths of stay, fewer readmissions
      and decreased costs. In this protocol, the investigators will conduct a prospective,
      randomized control study using a structured and integrative perioperative plan (ERAS; n = 64)
      vs. current standard of care (SOC; n = 64) for patients undergoing LSG at Hartford Hospital.
      The investigators are guided by the idea that an enhanced recovery protocol can potentially
      serve to enhance the early patient experience and set the stage for a more rapid transition
      out of the recovery phase and into the weight loss phase of the patient's care. The
      investigators will incorporate a postoperative multidrug strategy targeting multiple
      receptors to decrease PONV and pain, similar to ERAS Society recommendations for bariatric
      patients.

      Specific Aims and Hypotheses The central hypothesis is that the introduction of an ERAS
      pathway in patients undergoing LSG is feasible and will lead to better clinical outcomes.

      Aim 1. To evaluate the effect that introducing an ERAS pathway will have on the use of
      narcotic medication for the management of postoperative pain, PONV, readiness for discharge,
      and overall length of stay in patients undergoing LSG.

      Aim 2. To evaluate the safety of the ERAS protocol by measuring inpatient and 30-day adverse
      events, emergency department (ED) visits, outpatient hydration, readmission rates and
      delirium.

      Participants will be recruited through fliers posted at Surgical Weight Loss Center locations
      (Glastonbury, Enfield, Hartford, Farmington, Manchester and South Windsor).
    


Intervention name(s): Enhanced recovery after surgery protocol
Intervention type(s): Other
Intervention description(s): Experimental enhanced recovery protocol for pre-surgery and post surgery
Other intervention name(s): ERAS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: obesity; bariatric surgery; enhanced recovery after surgery; sleeve gastrectomy; gastric bypass
Strength Training for Chronic Stroke Patients
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      The study aims to investigate the effects of strength training on maximal strength, walking
      ability and neural function in chronic stroke patients. The strength training intervention in
      this study is different to all previous interventions for stroke patients.

      Maximal Strength Training (MST) involves weights of up to 90% of the participants 1
      repetition maximum and has a focus on the explosive development of force. This study will use
      these principles for unilateral leg press and plantarflexion exercises. Only 2 previous
      studies have investigated high intensity strength training for stroke patients and they used
      intensities of 80% 1RM. Previous MST interventions have shown large increases in strength,
      rate of force development and this has transferred to improved walking economy.

      The investigators predict that MST will give large increases in strength, improved rate of
      force development (RFD) and walking economy. The investigators expect that better neural
      function will account for the improvements. This study could provide evidence for the
      adoption of a completely different method of strength rehabilitation for stroke survivors.
    


Intervention name(s): Maximal strength training
Intervention type(s): Behavioral
Intervention description(s): Training will be carried out 3 times a week for 8 weeks. Each session will include a warm up, strength training and warm down. The total time will be approximately 1 hour. The training will consist 2 exercises (leg press and plantarflexion). Participants will train each leg individually with 4 sets of 4 repetitions at 90% of the 1 repetition maximum.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stroke; Strength training; exercise therapy
Study of a Device to Relieve Mosquito Bite Itching.
Condition: Mosquito Bites
MeSH terms: Pruritus
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether over-the-counter (OTC) use of the
      ZapperClick device employing the piezo-electricity principle is effective in reducing itching
      associated with mosquito bites.
    

Detailed description: 
      The ZapperClick is a therapeutic device that employs the piezo-electricity principle to
      soothe itching and ease the swelling from mosquito and horsefly bites as well as jellyfish
      and nettle stings. It accomplishes this by discharging 13KV at 0.7mA for 10 microseconds over
      the area of the bite or sting each time it is activated. In this clinical study, only the
      indication of reducing itching from mosquito bites will be evaluated. The theory behind the
      device's effectiveness is that multiple high voltage, low current electrical discharges over
      a bug bite or sting generates warmth over the immediate area of the bite or sting which
      inhibits the histamine release, thus relieving the symptoms of itching and swelling arising
      from the bite or sting. The device is a quick, simple and painless means of reducing the
      annoying symptoms of mosquito bites.
    

Intervention name(s): ZapperClick
Intervention type(s): Device
Intervention description(s): The ZapperClick is a therapeutic device that employs the piezo-electricity principle to soothe itching and ease the swelling from mosquito and horsefly bites as well as jellyfish and nettle stings. It accomplishes this by discharging 13KV at 0.7mA for 10 microseconds over the area of the bite or sting each time it is activated.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: mosquito bites; itching
AutoVPAP Versus VPAP; Assessment of Sleep and Ventilation
Condition: Chest Wall Disorder; Neuromuscular Disease
MeSH terms: Neuromuscular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study is to compare the effects of a modified form (AutoVPAP) of the VPAP
      non-invasive ventilator versus standard VPAP ventilation on sleep quality and breathing
      during sleep in stable patients with nocturnal hypoventilation due to restrictive ventilatory
      disorders (eg. neuromuscular disease or chest wall disorder).
    


Intervention name(s): VPAP non-invasive ventilator; AutoVPAP non-invasive ventilator
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Imaging of Islet Transplantation With PET and MRT
Condition: Islet Transplantation; Diabetes Type 1
MeSH terms: Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      Islets of Langerhans intended for clinical transplantation are labelled with a radioactive
      tracer. The tracer is retained in viable cells of the transplant. At infusion
      (transplantation) of the islets into the portal vein the tracer can be followed for two hours
      with positron emission tomography (PET). Imaging and calculations can give estimates of the
      proportion of surveying islets and the rate of early destruction. Also the distribution of
      the islets into the liver can be viewed.
    

Detailed description: 
      Background:

      It is suspected that the current need for repeated islets transplantation to treat diabetes
      type I is dependent on an early destruction of the islets when infused into the portal vein.

      Aim:

      To trace the fate of the islet at and after infusion into the portal vein.

      Method:

      Islets are labelled in vitro with a radioactive tracer that can be measured with positron
      emission tomography. 10-20 percent of the graft is labelled. Just prior to start of infusion
      labelled islets are mixed with unlabelled islets (80-90 percent of the graft). The tracer
      used is FDG and stands for 2-[18F]-2-deoxy-D-glucose. At infusion the patient is placed in
      the combined computer tomography and PET camera to follow the infusion. The imaging is almost
      continuous for 2 h at and after infusion.

      Expected results:

      Calculations of proportion of surviving islets and rate of destruction. Localisation and
      distribution of islets in the liver of the recipient.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients referred to islet transplantation in the Nordic countries (Scandinavia)
      
Keywords: Islet transplantation,; coagulation,; graft destruction,; islet imaging
Sleep in Pediatric HSCT
Condition: Sleep; Stem Cell Transplant Complications
Study type: Interventional

Summary: 
      Through an aggregated N=1 randomized controlled design (each patient will serve as their own
      control, with the 5-day intervention period determined by randomization), the current study
      will test the acceptability, feasibility, and impact on sleep and supportive care engagement
      of protecting one 6-hour window for nighttime sleep (intervention) relative to regular vitals
      checks (observation only periods) during Hematopoietic Stem Cell Transplant (HSCT) recovery.
    

Detailed description: 
      Context: Patients undergoing treatment for cancer face disease, treatment, and environmental
      obstacles to sufficient, sound sleep. Hospitalizations can further worsen sleep quality and
      quantity due to overnight vitals checks, medication administration, blood draws, and
      environmental noise and light. For patients undergoing hematopoietic stem cell transplant
      (HSCT), the risk for poor sleep is especially high due to protracted hospitalization,
      frequent vitals checks resulting in multiple night awakenings, and high symptom burden
      peaking approximately 10 days post-transplant.

      Objectives:

      Primary: Test the acceptability and feasibility of protecting one 6-hour window for nighttime
      sleep (intervention) relative to regular vitals checks (observation only periods) during HSCT
      recovery.

      Secondary: Assess the effect of one 6-hour window for nighttime sleep on subject sleep and
      engagement in supportive care on the oncology unit.

      Study Design:

      Aggregated N=1 randomized controlled design. All participants will undergo a 5 day
      observation and then be randomized to receive the 5 day intervention (extended vitals checks)
      during either nights of days +5-+9 or days +10-+14.

      Setting/Participants:

      Inpatients on the HSCT Unit at the Children's Hospital of Philadelphia (CHOP)

      Study Interventions and Measures:

      Intervention-increasing time between vitals checks from every 4 hours to one 6-hour period at
      night.

      Subjects will wear an actigraph for the duration of the study, complete a daily sleep diary,
      and complete self- and parent-proxy psychosocial measures (symptom burden, health related
      quality of life, sleep) and acceptability. Medical record review will also be conducted to
      assess vitals check frequency.
    

Intervention name(s): Extended time between vitals check
Intervention type(s): Behavioral
Intervention description(s): Participants will have 6 hours protected sleep time (vitals checks moved from every 4 to every 6 hours)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Aggregated N of 1 design (ABA or AAB)
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Multicenter Clinical Trial of Buprenorphine - 3
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test the efficacy and safety of buprenorphine.
    

Detailed description: 
      12 different sites for a total of 736 subjects (60 at Pizarro, 70 at West LA Tx center, 15 in
      the 1 year extension)
    

Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: Buprenorphine; Opioid
The Use of Midazolam as Adjuvant to Bupivacaine Intrathecal Anesthesia for Children Undergoing Lower Abdominal Surgeries.
Condition: Analgesia; Children, Only; Bupivacaine; Midazolam
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The study will be carried on children undergoing lower abdominal surgeries. Patients will be
      randomly categorized into two study groups. Group A will include patients who will receive
      bupivacaine intrathecal injection without adjuvant. Group B will include patients who will
      receive bupivacaine and preservative-free midazolam.
    


Intervention name(s): intrathecal bupivacaine; midazolam
Intervention type(s): Drug; Drug
Intervention description(s): The use of intrathecal bupivacaine will be compared to the use of intrathecal bupivacaine and midazolam.; midazolam
Other intervention name(s): intrathecal bupivacaine and midazolam
Intervention MeSH terms: Midazolam; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
Efficacy, Safety and Tolerability of Telbivudine in HBeAg Positive Chronic Hepatitis B Pregnant Women With Elevated Alanine Aminotransferase Levels
Condition: Chronic Hepatitis B; Pregnancy Complications; High Viral Load; Elevated Alanine Aminotransferase Levels
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic; Pregnancy Complications
Study type: Interventional
Phase: Phase 4

Summary: 
      Telbivudine reduces DNA and normalizes alanine aminotransferase levels (ALT) in chronic
      hepatitis B patients with few adverse effects, but its use during pregnancy has not been
      explored. In this open-label, prospective study from the second trimester to post-partum week
      28. This trial is to study the efficacy, safety and tolerability of Telbivudine in HBeAg
      Positive Chronic Hepatitis B Pregnant Women with high level of serum HBV DNA and elevated
      alanine aminotransferase levels.
    


Intervention name(s): Telbivudine treatment
Intervention type(s): Drug
Intervention description(s): Two arms in this study, One is Telbivudine 600 mg by mouth daily from late pregnancy to 28 weeks of post partum. Another arm is clinical observation only without telbivudine treatment
Intervention MeSH terms: Telbivudine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chronic hepatitis B; hepatitis B virus; perinatal transmission; Telbivudine