bioihbjkbjnl/mcl2 huggingface dataset:
SPI-directed Analgesia for Vitreoretinal Surgeries
Condition: Vitreoretinal Surgeries; Postoperative Nausea and Vomiting; Postoperative Pain
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      The aim of this randomized trial is to assess the efficacy of SPI-directed analgesia for
      vitreoretinal surgeries (VRS), presence of PONV and oculocardiac reflex (OCR) and compare
      Numerical Rating Scale (NRS) with Surgical Pleth Index (SPI) for monitoring pain perception
      postoperatively.

      Patients received general anaesthesia alone or combined with either preemptive analgesia
      using topical solution of 0,5% proxymetacaine or peribulbar block (0,5% bupivacaine with 2%
      lidokaine) or preemptive intravenous infusion of 1,0 g of metamizol or preemptive intravenous
      infusion of acetaminophen in a doseof 10-15mg/kg of body weight.
    

Detailed description: 
      Monitoring depth of anaesthesia using spectral entropy (SE) and quality of neuromuscular
      block are routine in modern anaesthesia, whereas monitoring of analgesia still requires
      further studies. Recently, the Surgical Pleth Index (SPI) was added as a surrogate variable
      showing the nociception-antinociception balance into abovementioned parametres constituting a
      novel approach in monitoring patients intraoperatively, known as adequacy of anaesthesia
      (AoA) or tailor-made anaesthesia.
    

Intervention name(s): Metamizol; Acetaminophen; 0,5 % bupivacaine with of 2% lidocaine; Proxymetacaine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): in group A patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1-1,25 gram; in group P patients will receive pre-emptive analgesia using intravenous infusion of acetaminophen in a single dose of 10-15 mg per kg of body weight; in group PBB patients in group BF will receive regional peribulbar block using a solution of 0,5% bupivacaine (2,5 ml) with 2% lidocaine (2,5 ml); in group T patients will receive topical analgesia using a solution of 0,5% Alcaine
Other intervention name(s): paracetamol; Lidocaine; Alcaine
Intervention MeSH terms: Acetaminophen; Dipyrone; Lidocaine; Bupivacaine; Proxymetacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Keywords: Surgical Pleth Index (SPI); General Anaesthesia (GA),; Numerical Rating Scale (NRS); Adequacy of Anaesthesia (AoA); Peribulbar Block (PBB); Topical Analgesia (TA); Oculocardiac reflex (OCR); Postoperative nausea nad vomiting (PONV); paracetamol; metamizol
A Comparison of Electrical Ilioinguinal Nerve Stimulation With Intravesical Irrigation for Bladder Pain Syndrome
Condition: Painful Bladder Syndrome
MeSH terms: Cystitis, Interstitial; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether electrical ilioinguinal nerve stimulation
      (EINS) is more effective than intravesical irrigation (II) in treating bladder pain syndrome.
    

Detailed description: 
      The purpose of this study is to determine whether electrical ilioinguinal nerve stimulation
      (EINS) is more effective than intravesical irrigation (II) in treating bladder pain syndrome.
    

Intervention name(s): Electrical ilioinguinal nerve stimulation; Intravesical Irrigation
Intervention type(s): Device; Procedure
Intervention description(s): Four abdominal points are selected. The upper two points are located 2.5 cun bilateral to Guanyuan (Ren 4). The lower two points are located 1.5 cun bilateral to Zhongji (Ren 3). Four long needles are punctured obliquely 1~2 cun in depth (depending on the fat layer thickness of the patient) to the four points to make the needling sensation reaching the urethra or vulva.
After the needling sensation reach the above regions, each of two pairs of electrodes from a device are connected with the two ipsilaterally inserted needles. The parameters are continuous waves, a frequency of 2.5 Hz and intensity that the patient feels comfortable for 60 min, three times a week for at least four weeks.; The patient was asked to lie on a couch in a lithotomy position after urination. A catheter was passed through the urethra into the bladder and any residual urine drained. The Cystistat 50mL 40mg (sodium hyaluronate, Bioniche Teoranta, Ireland) solution is instilled through the catheter into the bladder. The catheter is then withdrawn leaving the Cystistat inside the bladder coating the lining. It was recommended the solution was retained for as long as possible, ideally at least 30 minutes. The instillation is once weekly for at least four weeks.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: electrical ilioinguinal nerve stimulation; bladder pain syndrome; intravesical irrigation
Effect of Rifampicin on the Pharmacokinetics of SHR6390 in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the effect of rifampicin on
      pharmacokinetics of healthy Chinese adult subjects after oral administration of SHR6390
      tablets. The secondary objective of the study is to evaluate the safety of SHR6390 alone and
      when co-administered with rifampicin.
    


Intervention name(s): SHR6390 tablet single oral dose of SHR6390 or co-administered with rifampicin
Intervention type(s): Drug
Intervention description(s): 600 mg rifampicin was administered in the morning.
Other intervention name(s): rifampicin
Intervention MeSH terms: Rifampin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Durvalumab and Tremelimumab in Combination With First-Line Chemotherapy in Advanced Solid Tumors
Condition: Small Cell Lung Carcinoma; Carcinoma, Squamous Cell of Head and Neck; Stomach Neoplasms; Triple Negative Breast Neoplasms; Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Esophagogastric Junction Neoplasms; Carcinoma, Pancreatic Ductal; Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Neoplasms; Carcinoma, Squamous Cell; Breast Neoplasms; Esophageal Squamous Cell Carcinoma; Ovarian Neoplasms; Stomach Neoplasms; Small Cell Lung Carcinoma; Peritoneal Neoplasms; Triple Negative Breast Neoplasms; Fallopian Tube Neoplasms; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Pancreatic Ductal
Study type: Interventional
Phase: Phase 1

Summary: 
      Durvalumab and Tremelimumab in combination with first-line chemotherapy in the following
      indications: Ovarian/peritoneal/fallopian tube cancer, SCCHN, TNBC, SCLC and gastric/GEJ
      cancer, PDAC, ESCC.
    

Detailed description: 
      7 cohorts of first-line chemotherapy regimens combined with durvalumab + tremelimumab.

      This study will evaluate the safety and tolerability of durvalumab (MEDI4736) + tremelimumab
      in combination with first line chemotherapy regimens in patients with locally advanced or
      metastatic solid tumors: ovarian/peritoneal/fallopian tube cancer, squamous cell carcinoma of
      the head and neck (SCCHN), triple negative breast cancer (TNBC), small cell lung carcinoma
      (SCLC), and gastric/gastro-esophageal junction (GEJ) cancer, pancreatic ductal adenocarcinoma
      (PDAC) and esophageal squamous cell carcinoma (ESCC).
    

Intervention name(s): paclitaxel + carboplatin; carboplatin + etoposide; gemcitabine + carboplatin; nab-paclitaxel (paclitaxel-albumin) + carboplatin; oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid); durvalumab; tremelimumab; nab-paclitaxel (paclitaxel-albumin) + gemcitabine; cisplatin + 5-fluorouracil (5FU)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Biological; Biological; Drug; Drug
Intervention description(s): IV infusion; IV infusion; IV infusion; IV infusion; IV infusion and bolus administration; IV infusion; IV infusion; IV infusion; IV infusion
Other intervention name(s): Platinum based Standard of Care Chemotherapy; Platinum based Standard of Care Chemotherapy; Platinum based Standard of Care Chemotherapy; Platinum based Standard of Care Chemotherapy; Platinum based Standard of Care Chemotherapy; MEDI4736; Standard of Care Chemotherapy; Platinum based Standard of Care Chemotherapy
Intervention MeSH terms: Leucovorin; Folic Acid; Paclitaxel; Etoposide; Albumin-Bound Paclitaxel; Carboplatin; Gemcitabine; Fluorouracil; Oxaliplatin; Durvalumab; Tremelimumab; Levoleucovorin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: durvalumab, tremelimumab, metastatic, solid tumors, immuno-oncology, first-line chemotherapy, esophageal, pancreatic
Phyllantus Amarus for the Protection of Liver Health
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a randomized, double-blind, placebo controlled crossover study. The purpose of
      this study is to assess the ability of Phyllantus amarus to protect the liver against
      temporary stress including oxidative stress induced by alcohol consumption.
    


Intervention name(s): Phyllantus amarus; Placebo
Intervention type(s): Dietary Supplement; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Liver Health; Hangover; Herbal supplement; Liver function
A Study to Evaluate the Mass Balance of [14C]SHR2554 in Healthy Adult Volunteers
Condition: Lymphoma
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluate the Mass Balance of [14C]SHR2554 in Healthy Adult Male Volunteers.
    


Intervention name(s): [14C]SHR2554
Intervention type(s): Drug
Intervention description(s): Patients will receive single dose of orally [14C]SHR2554 on Day 1.
Intervention model: Single Group Assignment
Intervention model description: Single oral dose of [14C]SHR2554
Masking: None (Open Label)
Primary purpose: Other
Measure the Serum Level of Homocysteine in Acne Patients Before and After Oral Isotretinoin.
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      Serum homocysteine level in Acne patients before and after oral Isotretinoin and Correlation
      between serum level of homocysteine in acne patients before and after Oral isotretinoin
      treatment
    

Detailed description: 
      Acne vulgaris is a common chronic inflammatory disease of the skin. It is found in about 80%
      of young adults and adolescents. It is a disease that affects the pilosebaceous units of the
      skin and may result in inflammatory or non-inflammatory lesions,Oral isotretinoin
      (13-cis-retinoic acid) is the only drug that counteracts all the pathogenetic mechanisms that
      contribute to the development of acne The standard dose of isotretinoin is 0.5 to 1 mg/kg per
      day for 4 months to a cumulative dose of 120-140 mg/kg is effective in the management of acne
      vulgaris The scope of our study is to detect serum homocysteine level in acne patient befor
      and after oral isotrtinoin treatment
    

Intervention name(s): Isotretinoin
Intervention type(s): Drug
Intervention description(s): Isotretinoin is a vitamin-A derivative for treatment of moderate to severe acne used in a dose from 20-40 mg for 3 months duration
Intervention MeSH terms: Isotretinoin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: group of patients and group of control
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Efficacy and Safety of a Purified Standardised Wasp Venom Preparation
Condition: Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The trial is performed to assess efficacy and safety of a purified standardised wasp venom
      preparation in wasp venom allergy
    


Intervention name(s): wasp venom
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Wasp venom allergy,; specific immunotherapy
Promising Initial Experience With Intra-operative Fluorescent Cholangiography
Condition: Gall Stone Disease
MeSH terms: Gallstones; Cholelithiasis; Cholecystolithiasis
Study type: Interventional

Summary: 
      Intraoperative fluorescent cholangiography (IFC) with concomitant fluorescent angiography is
      a recently developed method for non-invasive visualisation of the relevant anatomy during
      laparoscopic cholecystectomy. The objective of this study was to assess the time required by
      routine-use of IFC and to evaluate success-rate of the procedures.

      Methods Thirty-five patients scheduled for laparoscopic cholecystectomy and operated by the
      same surgeon were consecutively enrolled. A standardized protocol with IFC including
      concomitant angiography was performed during laparoscopic cholecystectomy. Intra-operative
      time-registration and exposure of predefined anatomical structures were recorded.
    


Intervention name(s): Intraoperative fluorescent cholangiography (IFC)
Intervention type(s): Procedure
Intervention description(s): A standardized protocol with IFC including concomitant angiography was performed during laparoscopic cholecystectomy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Fluorescent cholangiography; Laparoscopic cholecystectomy
Modified Sternal Precautions Versus Conventional Sternal Precautions in Physical Function After Sternotomy
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      This research study Effectiveness of modified sternal precautions versus conventional sternal
      precautions in improving physical function after sternotomy .After recruitment of the
      subjects, the intervention group will receive modified sternal precaution while the control
      group will receive conventional sternal precautions and they will be assess for their
      physical activity, kinesiophobia, quality of life and post sternotomy pain.
    

Detailed description: 
      This study will address the scarcity of research and the variations in recommendations
      regarding sternal precautions and restrictions of upper limb movement in cardiac patients and
      will help to evaluate the effect of modified sternal precautions on patients' pain and
      functional activity. As physical therapists are the ones who have maximum exposure to
      practice and teaching of sternal precautions, therefore this study will help to formulate the
      guidelines regarding the use of upper limb during cardiac rehabilitation exercises and making
      standards for sternal precautions and its management following cardiac surgery.
    

Intervention name(s): Modified sternal precautions; Conventional sternal precautions
Intervention type(s): Other; Other
Intervention description(s): Use pain and discomfort to guide the safe use of the arms Avoid pushing or pulling with one arm Use both arms close to the body during lifting Use of arms is possible, but keep them close to the body Avoid stretching one or both arms backwards at the same time Use a cushion or perform sternal preservation technique (crossing the arms in a 'self-hugging 'posture) when coughing.
When transferring, roll onto the side, ease the legs over the edge of the bed and carefully use the arms to sit up from a lying position; Avoid pushing or pulling through the arms Avoid one-arm (unilateral) activity Limit the elevation of the arms to 90 degrees Avoid lifting objects heavier than 2 kg Use a cushion or perform sternal preservation technique (crossing the arms in a 'self-hugging' posture) when coughing Limit the use of the arms when transferring from sitting to standing and getting out of bed Avoid placing the arms behind the back
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sternal precautions; Sternal restrictions; CABG
Sonographic Analysis of Nails in Psoriatic Arthritis and Healthy Controls
Condition: Psoriatic Arthritis; Psoriatic Nail
MeSH terms: Arthritis; Arthritis, Psoriatic
Study type: Observational

Summary: 
      This study aims to identify the nail ultrasonography (NUSG) properties in patients with
      psoriatic arthritis (PsA) and healthy controls by a participant-based evaluation; to assess
      feasibility, reliability, and discriminative performances; to explore final scorings; and to
      determine associations between the NUSG scores and participant characteristics, including
      demographics and disease-related factors.
    

Detailed description: 
      NUSG is a visualization method suitable for evaluating the subunits of the nail. The main
      purpose of this study is to identify NUSG properties in patients with PsA and healthy
      controls. The investigators recruited patients with PsA according to the CASPAR criteria and
      sex- and age-matched healthy controls into the study. NUSG parameters were examined by
      grayscale and power Doppler techniques for all of the fingernails and first toenails (12
      nails); and five scorings including nail plate impairment score (NPIs), nail plate thickness
      score (NPTs), nail bed thickness score (NBTs), nail thickness score (NTs), and the Doppler
      activity score (DAs) were calculated. The investigators compared the PsA and control groups
      in terms of the NUSG scorings and also documented the discriminative performances (with
      receiver operating characteristic curve analysis) of the scorings. Then, the feasibility and
      reliability analysis of the NUSG scorings were performed. Finally, the association between
      the NUSG scores and participant characteristics, including sex, age, body weight, height,
      labor market participation, smoking, hemoglobin, disease duration, history of dactylitis,
      current enthesitis, radiographic sacroiliitis, C reactive protein, minimal disease activity,
      Disease Activity Index for Psoriatic Arthritis, Nail Psoriasis Severity Index, and Psoriasis
      Area Severity Index were explored.
    

Intervention name(s): Nail Ultrasonography
Intervention type(s): Diagnostic Test
Intervention description(s): The MyLab 60 (Esaote Biomedica Genoa, Italy) device and linear probe were used. Nails were examined in B-mode grayscale and power Doppler.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All patients met the CASPAR criteria and healthy controls had no inflammatory or mechanical
        musculoskeletal disease. Participants in the age range of 18-70 were included.

        The control group was recruited from the healthy relatives of the hospital staff.

        The PsA group was recruited from Marmara University Physical Medicine and
        Rehabilitation/Rheumatology clinic.
      
Keywords: nail ultrasonography; psoriatic arthritis
The Effect of Sitting and Moderate Exercise on Plasma Triglyceride Elevation After a Meal
Condition: Atherosclerosis; Metabolic Syndrome
MeSH terms: Atherosclerosis; Metabolic Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effect of 4 days of sitting and moderate
      exercise on plasma triglyceride elevation after a meal.
    

Detailed description: 
      Subjects will undergo three weeks (two intervention, one washout) of testing during which
      they will participate in two conditions: 1) prolonged sitting (~14-hours/day) with a 1-hour
      bout of acute exercise at 65% of pre-intervention VO2max and 2) prolonged sitting
      (~14-hours/day) without an acute bout of exercise. During each intervention week, subjects
      will have 2 days of dietary and activity control, followed by 4 days during which prolonged
      sitting will occur. On the evening of the 4th day, subjects in the exercise group will
      perform the acute bout of exercise. On day 5, all subjects will undergo a lipid tolerance
      test to determine the body's ability to clear triglycerides from the blood as well as
      insulin/glucose response and substrate oxidation. Blood samples will be assayed for the
      previously mentioned substances and postprandial gas collection will be analyzed via indirect
      calorimetry.
    

Intervention name(s): Prolonged sitting with exercise; Prolonged sitting without exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects will have a 2-day control period during which step count and diet will be controlled for and recreated for the other trial. Following this 2-day period, they will undergo the prolonged sitting trial with the acute bout of exercise on day 4. Day 5 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides.; Subjects will have a 2-day control period during which step count and diet will be controlled for and recreated for the other trial. Following this 2-day period, they will undergo the prolonged sitting trial, but will not be asked to complete an acute bout of exercise on day 4. Day 5 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects will be randomly assigned to either the sitting plus exercise or the sitting without exercise group and then, after a one week washout period, complete the other task.
Masking: None (Open Label)
Primary purpose: Prevention