bioihbjkbjnl/mcl2 huggingface dataset:
Opioids and Esophageal Function
Condition: Pharyngeal Dysfunction; Esophageal Dysfunction
MeSH terms: Esophageal Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate if opioid-induced effects on the pharynx and
      esophagus is centrally or peripherally mediated.
    

Detailed description: 
      Opioids induce pharyngeal and esophageal dysfunction and reduce the lower esophageal
      sphincter (LES) pressure, and thereby decreases the barrier pressure between the stomach and
      esophagus. This contributes to an increased risk of regurgitation and aspiration during
      anaesthesia induction and in the postoperative period, when the patient is treated with
      opioids for pain relief. The effects of opioid antagonists on the opioid induced pharyngeal
      dysfunction and lower esophageal sphincter pressure are unknown. Therefore it is of great
      clinical value to evaluate if these negative effects are reversed by peripheral opioid
      antagonist, methylnaltrexone.

      Methylnaltrexone is one of the newer agents of peripherally acting opioid antagonists that
      act to reverse some of the side effects of opioid drugs, such as constipation, without
      affecting analgesia.

      If the opioid induced pharyngeal and esophageal dysfunction and reduction of the lower
      esophageal sphincter pressure is peripherally induced or mediated via peripheral opioid
      receptors, methylnaltrexone might reverse these effects and thereby reduce postoperative
      morbidity by reducing pulmonary complications. On the other hand, if the dysfunction is
      centrally induced and not mediated via peripheral opioid receptors there is no effect of
      methylnaltrexone.

      The pharyngeal and esophageal motility/function can be registered in an easy and objective
      way with the high resolution manometry, ManoScan 360. ManoScan 360 is an equipment with 36
      sensors at 1 cm spacing with 12 tip transducers at every sensor. The 36 closely spaced
      sensors automatically capture all relevant motor function from the pharynx to the stomach.
      The system collects reliable and consistent data records with improved diagnostic accuracy,
      and the data are analyzed using ManoView analyzes software. ManoScan 360 has a CE mark
      approval and has been used at Örebro University Hospital during the last two years.
    

Intervention name(s): methylnaltrexone
Intervention type(s): Drug
Intervention description(s): 0,15 mg/kg sc ( subcutaneously)once per volunteer
Other intervention name(s): Relistor
Intervention MeSH terms: Methylnaltrexone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: methylnaltrexone; upper esophageal sphincter; lower esophageal sphincter; high resolution solid state manometry; opioid induced pharyngeal and esophageal dysfunction
Massage Therapy for Chronic Low Back Pain
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether massage is effective in the treatment of
      low back pain and to optimize clinical therapeutic schedule of massage for low back pain.
    

Detailed description: 
      Chronic low back pain is a prevalent condition among adults. Large majority of the population
      suffer from Chronic low back pain in their lifetime. At present, there is still no standard
      treatment for chronic low back pain. Massage is commonly chose and widely used by sufferer as
      a complement to conventional treatment. However, its effectiveness is still not convinced.
      This trial is designed to assess the effectiveness of massage for chronic low back pain.
    

Intervention name(s): Massage; Ibuprofen
Intervention type(s): Other; Drug
Intervention description(s): Massage therapy is an intervention that can be used to relax muscle and regulate displaced joints by manual manipulation.; Ibuprofen is an common analgesics which has been widely used in regular control of various pain symptom.
Other intervention name(s): Tuina; Pain killer
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: massage; low back pain
The Effect of Bevacizumab on Corneal Neovascularization
Condition: Corneal Neovascularization
MeSH terms: Corneal Neovascularization; Neovascularization, Pathologic
Study type: Interventional
Phase: Phase 4

Summary: 
      Eight patients with corneal neovascularization were treated with subconjunctival injection of
      1.25 mg bevacizumab and had a follow-up of at least 2 months. All patients had persistent
      corneal neovascularization for at least 6 months unresponsive to other treatments. Patients
      were monitored by ophthalmic exam and anterior segment photography.
    

Detailed description: 
      To evaluate the effect of repeated subconjunctival bevacizumab (Avastin®, Roche, Rio de
      Janeiro, Brazil) on inflammatory corneal neovascularization.

      Eight patients with corneal neovascularization were treated with subconjunctival injection of
      1.25 mg bevacizumab and had a follow-up of at least 2 months. All patients had persistent
      corneal neovascularization for at least 6 months unresponsive to other treatments. Patients
      were monitored by ophthalmic exam and anterior segment photography.
    

Intervention name(s): Bevacizumab
Intervention type(s): Drug
Intervention description(s): subconjunctival injection of 1.25 mg bevacizumab and had a follow-up of at least 2 months
Intervention MeSH terms: Bevacizumab
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: bevacizumab; cornea; neovascularization
Effects of Short Duration High-intensity Interval Training on Peak Oxygen Consumption
Condition: Cardiovascular Fitness
Study type: Interventional

Summary: 
      High-intensity interval training (HIIT) is an effective tool to improve cardiovascular
      fitness and maximal anaerobic power. Different methods of HIIT have been studied but the
      effect of a maximal effort cycling and very short exercise time (i.e., 4-s) with short
      recovery time (15-30 s) and a high number of repetitions (i.e., 30 bouts) is unknown.
    

Detailed description: 
      The investigators examined the effects of training at maximal anaerobic power during cycling
      (PC) on maximal anaerobic power, peak oxygen consumption (VO2peak), and total blood volume in
      11 young healthy individuals (age: 21.3±0.5 y) (6 men, 5 women). Methods: Participants
      trained three times a week for eight weeks performing a PC program consisting of 30 bouts of
      4-s at an all-out intensity (i.e., 2 minutes of exercise per session). The cardiovascular
      stress progressively increased over the weeks by decreasing the recovery time between sprints
      (30 to 24 to 15-s) and thus session time decreased from 17 to < 10 min.
    

Intervention name(s): 4-s sprint inertial load training
Intervention type(s): Other
Intervention description(s): A program employing 30 bouts of 4s inertial load sprint training with progressively reduced recovery time (30 to 15 s) between sprints is effective for improving blood volume, VO2peak and maximal power.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exercise; cardiovascular fitness; sprinting; performance
Effect of a Liquid Toothpaste on Periodontal Disease
Condition: Periodontitis; Gingivitis
MeSH terms: Gingivitis; Periodontitis; Periodontal Diseases
Study type: Interventional

Summary: 
      The aim of the present clinical study is to evaluate the efficacy and safety of the novel
      toothpaste in patients diagnosed with gingivitis and/or periodontitis.
    

Detailed description: 
      The trial was a randomized, double-blind, placebo-controlled, parallel group,
      single-center(Department of periodontology, Yonsei University Dental Hospital) study.

      98 patients were assessed for eligibility. Since two patients did not meet the inclusion
      criteria, 96 subjects were randomly assigned to either the test group.The test group was
      provided a liquid toothpaste and a control group received placebo. At the end of the study,
      results were analyzed for 87 patients : 42 in the test group and 45 in the control group .

      The study protocol requested 4 visits- once every two weeks-of each subjects in the center.
      At the baseline, subjects were randomly allocated to the test group or the control group.
      Scaling and tooth brushing instruction were performed and all of the clinical parameters were
      evaluated. At the 2- and 4-week examinations, clinical parameters of GI, PI were evaluated
      and at the 6-week examination, all of the clinical parameters were evaluated.

      Also, Microbiological quantitative analysis of this procedure was performed at the baseline
      and 6-week examinations.
    

Intervention name(s): DA-5502 liquid toothpaste; placebo
Intervention type(s): Other; Other
Intervention description(s): 6 weeks study, brush three times daily, liquid toothpaste; same flavor solution, brush three times daily
Other intervention name(s): DA-5502, Gumguard
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study in Healthy Japanese Men to Test How Well Different Doses of BI 765845 Are Tolerated
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of this trial are to investigate safety, tolerability and
      pharmacokinetics (PK) of BI 765845 in healthy male Japanese subjects following intravenous
      administration of single rising doses.
    


Intervention name(s): BI 765845; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): BI 765845; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject
Condition: Diphtheria; Pertussis; Tetanus; Hepatitis B; Haemophilus Infections
MeSH terms: Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Haemophilus Infections; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to show that vaccination with three doses of Quinvaxem presented in Uniject
      is not inferior to vaccination with three doses of Quinvaxem presented in single dose vials,
      with respect to protection against all antibodies (anti-hepatitis B surface antibodies,
      anti-polyribosyl ribitol phosphate (PRP), anti-diphtheria, anti-tetanus and anti-Bordetella
      pertussis) one (1) month after completion of the 6-10-14 week vaccination course.
    


Intervention name(s): Quinvaxem in Uniject; Quinvaxem in single dose vials
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Vaccination; Immunisation; Virus; Diphtheria; Pertussis; Tetanus; Hepatitis B; Haemophilus Influenzae; Immunity
Evaluate Retention of an Orally Administered Device Using Gamma Scintigraphy Study 2
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Single usage, open label study in up to 40 adult healthy males. Eligible subjects will
      receive a single usage of the investigational or commercial device. Retention of the
      radiolabeled device will be monitored using gamma scintigraphy.
    


Intervention name(s): Polymer based lubricating liquid; Moi-Stir
Intervention type(s): Device; Device
Intervention description(s): 5 mls of radiolabeled polymer blend of carboxymethylcellulose, polyoxyl 40 stearate, and polyethylene oxide that coats and protects the mucus membrane; 2 sprays (0.35 mL) of the radiolabeled commercial device. A blend of Water, sorbitol, carboxymethylcellulose, sodium, methylparaben, propylparaben, potassium chloride, dibasic sodium phosphate, calcium chloride, magnesium chloride, sodium chloride, flavor.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Urinary Kallidinogenase in Acute Ischemic Stroke Patients With Abnormal Glucose Metabolism
Condition: Acute Ischemic Stroke; Abnormal Glucose Metabolism
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Observational

Summary: 
      Urinary kallidinogenase may assist recovery acute ischemic stroke. This study evaluated the
      impact of urinary kallidinogenase on NIHSS score, modified Rankin scale (mRS) score and
      fasting glucose levels in patients with AIS combined with diabetes mellitus and impaired
      fasting glucose.
    

Detailed description: 
      Patients with AIS and abnormal glucose metabolism were enrolled in this prospective cohort
      study and divided into two groups. The HUK group were treated with urinary kallidinogenase
      and standard treatment, the control group received standard treatment. NIHSS scores, mRS
      scores and fasting blood glucose were evaluated and compared.
    

Intervention name(s): Urinary Kallidinogenase
Intervention type(s): Drug
Other intervention name(s): Kai Li Kang
Intervention MeSH terms: Kallikreins
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with AIS combined with diabetes mellitus and impaired fasting glucose who was
        meets the Inclusion and Exclusion Criteria were enrolled in this prospective cohort study
        and divided into two groups.
Comparison of Laparoscopic Proximal Gastrectomy and Laparoscopic Total Gastrectomy
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      Experimental: Laparoscopic proximal gastrectomy Laparoscopy proximal gastrectomy with
      esophago-jejunostomy, gastro-jejunostomy and jejuno-jejunostomy (double tract
      reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should
      be negative for malignancy with intraoperative frozen biopsy.

      Active Comparator: Laparoscopic total gastrectomy Laparoscopic total gastrectomy with
      esophago-jejunostomy and jejuno-jejunostomy (Roux-en-Y reconstruction). Systemic en bloc
      lymph node dissection is mandatory. Resection margin should be negative for malignancy with
      intraoperative frozen biopsy.
    

Detailed description: 
      Participating Surgeons Prior to this clinical trial, only the surgeons who are considered to
      have the standardization by review committee participated.

      Patients Registration It is required to ensure that the patients meet the inclusion criteria
      for this clinical trial, are free from any items of exclusion criteria, are explained about
      the participation in the clinical trial along with the informed consent forms.

      After rechecking the patients with the registration check list by accessing the web-based
      randomized program provided from Seoul National University Bundang Hospital Medical Research
      Collaborating Center.

      Each group 69 patients, total 138 subjects will be enrolled. Randomization The registration
      randomization should be done with 1:1 ratio for each researcher.

      Baseline number (BN) should be provided to the subjects in the order of acquisition of
      informed consent form. Based on the subjects who are selected as the appropriate subjects in
      the end, the allocation number (AN) shall be provided in the order of randomized allocation
      table.

      Procedure Operations are performed according to the allocated group.
    

Intervention name(s): Laparoscopic proximal gastrectomy; Laparoscopic total gastrectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Laparoscopy proximal gastrectomy with esophago-jejunostomy, gastro-jejunostomy and jejuno-jejunostomy (double tract reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.; Laparoscopic total gastrectomy with esophago-jejunostomy and jejuno-jejunostomy (Roux-en-Y reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Skin Tape Harvesting for Transcriptomics Analysis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional

Summary: 
      Transcriptomics is the study of how RNA is expressed under specific conditions.
      Transcriptomic analyses of lesional skin biopsies can be a useful way to track how a patient
      responds to a drug and separate out drug responders from non-responders. However, biopsies
      are painful, carry risk of bleeding infections and scarring. A non-invasive approach, such as
      tape-harvesting, to obtain transcriptomic data from psoriatic skin would increase our
      capabilities to monitor patients on treatment and potentially help us predict if the drug
      will be effective sooner. However, it is not known how well tape-harvesting can capture
      transcriptomic changes that are occurring in psoriatic skin. The purpose of this study is to
      address how well tape-harvesting captures the transcriptomic changes that are occurring in
      psoriatic skin.
    


Intervention name(s): Skin Tape Stripping; Punch Biopsy
Intervention type(s): Procedure; Procedure
Intervention description(s): For psoriasis group, tape-stripping will be done in both involved and uninvolved skin. The tape-stripping will be performed within 2.5 cm of the first punch biopsy. For healthy control group, tape-stripping will be performed on normal skin, within 2.5. cm of the first punch biopsy.; For psoriasis group, one punch biopsy will be taken from each of the following areas: involved skin, tape-stripped involved skin, uninvolved skin, and tape-stripped uninvolved skin. For healthy control group, one punch biopsy will be taken from each of the following areas: normal skin and tape-stripped normal skin (within 2.5 cm of the first punch biopsy).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Trial to Assess Campath-1H and Tacrolimus Followed by Immunosuppression Withdrawal in Liver Transplantation
Condition: Transplantation, Liver
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a prospective, multicenter open-label single arm trial in which recipients of liver
      allograft will receive uniform immunosuppressive induction and maintenance regimens.
      Participants with end stage liver disease who meets the entry criteria will be consented and
      enrolled.

      Participants receive Campath-1H and maintenance immunosuppression with tacrolimus therapy.
      After one year of tacrolimus therapy, an assessment of the immunologic status including blood
      gene expression and geno-race studies will be performed which will include studies on the
      liver graft biopsy. At this time, patients will be selected to undergo immunosuppressive
      withdrawal. This will be made on an individual basis with definitive inclusion and exclusion
      criteria.

      The objectives of the study are to evaluate the safety and efficacy of immunosuppressive
      regimens comprising Campath-1H induction followed by maintenance immunosuppressive therapy
      with tacrolimus on allograft survival. However, secondary objectives will be to assess
      withdrawing tacrolimus after Campath-1H induction in an immune depletion and subsequent
      immune reconstitution. This study will evaluate whether a combination of anti-rejection
      medications (Campath-1H and tacrolimus) can prevent rejection and allow the body to develop
      tolerance to the transplanted liver.
    


Intervention name(s): Campath-1H and Tacrolimus
Intervention type(s): Drug
Intervention MeSH terms: Alemtuzumab; Tacrolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Orange Almond Potato Cookies Supplementation
Condition: Nutritional Stunting
MeSH terms: Growth Disorders
Study type: Interventional

Summary: 
      The goal of this clinical trial is to assess the effect of potato almond orange cookie
      supplementation on the nutritional status of stunted under-five children.

      The main questions aimed to answer are:

        -  Can cookie supplementation improve the weight of stunted under-five children?

        -  Can cookie supplementation improve the weight for age z score of stunted under-five
           children?

      Participants divided in the two groups i.e.:

        -  Treatment group received 50 g potato almond orange cookie each day during 4 weeks.

        -  Control group received 50 g potato orange cookie each day during 4 weeks.

        -  Mothers of both groups given balanced nutrition education for stunted under-five
           children twice at the second and third week of study.
    

Detailed description: 
      Treatment group received 50 g potato almond orange cookie each day during 4 weeks.

      Control group received 50 g potato orange cookie each day during 4 weeks.
    

Intervention name(s): Almond orange potato cookies for stunted under-five children
Intervention type(s): Dietary Supplement
Intervention description(s): Trained enumerator distributed 50 g cookies three times a week during 30 days to the treatment group.
Anthropometry measurement: weight and height measured at pre study, during study (once a week), and post study.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: One treatment group received almond orange potato cookies during 4 weeks. One control group received almond potato cookies during 4 weeks.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: COVID19; stunted under-five children; weight; HAZ score; orange almond potato cookies
Assess the Effect of Cangrelor at the Therapeutic Dose and a Supratherapeutic Dose Level on the QT/QTc Interval in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the safety of cangrelor on cardiac repolarization as measured by electrocardiogram
      (ECG) at therapeutic and supratherapeutic doses.
    


Intervention name(s): cangrelor; cangrelor; cangrelor; moxifloxacin; placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): IV bolus 60 mcg/kg; 8 mcg/kg x 3 hrs; 30 mcg/kg bolus; 4 mcg/kg/min x 3 hrs. Oral placebo capsule; 60 mcg/kg bolus; 8 mcg/kg/min x 3 hrs. Oral placebo capsule; 400 mg orally. Placebo IV bolus and infusion.; placebo IV and oral
Intervention MeSH terms: Moxifloxacin; Cangrelor
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Keywords: ECG; QT; Effect of study drug on healthy volunteers