bioihbjkbjnl/mcl2 huggingface dataset:
ACVBP Plus Rituximab Versus CHOP Plus Rituximab in Patients With Diffuse Large B-cell Lymphoma and Age-adjusted IPI of 1
Condition: Diffuse Large-Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a multicentric randomized trial evaluating the efficacy of the combination
      ACVBP+rituximab compared to the combination of CHOP+rituximab in patients aged from 18 to 59
      years with diffuse large B-cell lymphoma and one factor of the age-adjusted international
      prognostic index (IPI).
    

Detailed description: 
      This phase III multicentric open label randomized study is based on the results of previous
      LNH 93-5 and LNH98-5 studies.

      The LNH93-5 study has shown that the ACVBP regimen gave a longer EFS (39% vs 29% at 5 years,
      p=0.005) and a longer overall survival (46% vs 38% at 5 years, p=0.036) than CHOP in patients
      aged between 61 and 69 with an IPI score ≥1. However ACVBP had a more important toxicity and
      a higher treatment related mortality (13% vs 7%, p<0.01), specially after 65 years. In
      younger patients ACVBP is better tolerated.

      The addition of Rituximab to standard CHOP (R-CHOP) has been shown in LNH98-5 study to
      improve complete remission rate (CR), event-free survival (EFS) and overall survival (OS) in
      elderly patients with B-DLCL. Considering only patients with an aa-IPI score of 1, the 2 year
      EFS was 75% in the R-CHOP group as compared with 42% in the CHOP group.

      This study is designed to test whether addition of rituximab to ACVBP is better than R-CHOP
      in patients younger than 60. Primary endpoint is event-free survival, we expect a gain in 2
      years-EFS of 10% in R-ACVBP group as compared with R-CHOP group.

      This study is a multicentric, phase III open-label, randomized trial evaluating the efficacy
      of ACVBP+rituximab compared to CHOP+rituximab in patients aged from 18 to 59 years with non
      previously treated diffuse large B-cell lymphoma and one factor of the age-adjusted
      international prognostic index
    

Intervention name(s): rituximab; doxorubicin; cyclophosphamide
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Cyclophosphamide; Rituximab; Doxorubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lymphoma, diffuse large B-cell; rituximab; chemotherapy
BE of Torrent's Esomeprazole Mg DR Capsules
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Subjects to compare the single dose bioavailability of Torrent's Esomeprazole Mg DR Capsule
      1×40 mg and Nexium 40 mg DR Capsule containing Esomeprazole 40 mg of AastraZeneca LP, USA.
      Dosing periods of studies were separated by a washout period of 5 days.
    

Detailed description: 
      An open Label, Randomized, 2-Period, 2-Treatment,2-Sequence, Crossover, Single-Dose
      Bioequivalence Study of Esomeprazole Mg DR Capsule containing Esomeprazole Mg 40 mg [ Test
      Formulation, Torrent Pharmaceutical Ltd., India] Versus Nexium 40 mg DR Capsule containing
      Esomeprazole 40 mg [Reference Formulation, AastraZeneca LP, USA] Under administered as the
      contents of capsule sprinkled over apple sauce in Healthy Human Volunteers Under Fasting
      Condition.
    

Intervention name(s): Nexium 40 mg DR Capsules of AstraZeneca LP, USA.; Torrent's Esomeprazole Magnesium DR Capsules 40 mg
Intervention type(s): Drug; Drug
Intervention description(s): oral, crossover; oral, crossover
Other intervention name(s): esomeprazole magnesium delayed release capsules; esomeprazole magnesium delayed release capsules
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Emotion Awareness and Skills Enhancement Program
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This project will address impaired emotion regulation in adolescents with ASD (autism
      spectrum disorder). There are no evidence-based interventions to improve emotion regulation
      (ER) in this population, yet poor emotion regulation often leads to maladaptive behavior and
      substantially impedes capacity to learn and function across all life settings, and reduce
      their quality of life and that of their families. The primary objective of this study is to
      formally evaluate efficacy of EASE via a sufficiently powered, two-site randomized-controlled
      trial (RCT).
    

Detailed description: 
      The current study is to test a new intervention called Emotional Awareness and Skills
      Enhancement (EASE). This program was designed to address ASD-specific obstacles to effective
      emotion regulation, such as reduced awareness concerning others' intentions, a limited
      repertoire of behavioral responses, and inadequate language for understanding emotional
      experiences. This new program is based on an acceptance-based approach in which awareness of
      emotion is developed, emotions (whether negative or positive) are accepted, and behavior is
      regulated in the face of intense emotion. The goal is not to learn to avoid negative
      emotions, but rather to develop a collection of abilities which allow the individual to
      manage stress and act in ways that are more adaptive. The investigators expect to find that
      participants' emotion dysregulation will decrease and their adaptive function will increase
      following completion of the EASE program.
    

Intervention name(s): EASE; Supportive Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Weekly behavioral sessions with therapist to work on emotional control through measures such as mindfulness.; Weekly behavioral sessions with a therapist to work on emotional control
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: per protocol analysis versus intent to treat analytic approach due to the pandemic
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Myocardial Oedema in ST Segment Elevation Myocardial Infarction Myocardial
Condition: ST Segment Elevation Myocardial Infarction; Myocardial Oedema
MeSH terms: Myocardial Infarction; ST Elevation Myocardial Infarction; Infarction; Edema
Study type: Observational

Summary: 
      Cardiac magnetic resonance imaging (CMR) is a non invasive technique used to obtain
      functional and anatomical information on the heart. Several CMR parameters measured after
      primary percutaneous coronary intervention (PPCI) have been shown to have prognostic value
      and are increasingly being used as surrogate endpoints in clinical trials. Myocardial oedema
      is a prognostic indicator following myocardial infarction1. Myocardial salvage is calculated
      as the myocardial oedema minus infarct size; this again is a prognostic indicator following
      STEMI. However, myocardial oedema imaging is controversial. There are multiple sequences
      available, with no standardisation of sequences used to assess this surrogate endpoint. The
      investigators propose to conduct a study to measure the myocardial oedema by all available
      techniques to determine the agreement between these methods.
    


Intervention name(s): Cardiac magnetic resonance imaging
Intervention type(s): Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        30 patients will be undergo a CMR scan day 2 following STEMI
      
Keywords: STEMI; Myocardial edema; Cardiovascular magnetic resonance
The Use of the Hem-o-lok Clip in Appendectomy: Single or Double?
Condition: Acute Appendicitis
MeSH terms: Appendicitis
Study type: Observational [Patient Registry]

Summary: 
      Stump safety is provided by different methods in laparoscopic appendectomy. Stapler use,
      binding with endoloop and nonabsorbable clip are the most common methods. Although the
      stapler is safe, it creates a significant cost increase. In connecting with the endoloop, the
      learning curve and surgical time are longer. Nonabsorbable clip application which has been
      used recently; Urethra was also used in appendectomy after its safety has been proven by
      large studies to close cystic ducts and vascular structures. Its advantages such as low cost,
      no need for a learning curve and shortening the surgical time have increased the frequency of
      use.In this prospective observational study; It will be aimed to investigate the effects of
      stump closure methods applied in laparoscopic appendectomy on short-term clinical results. In
      addition, the factors that determine the surgeon's stump closure method and cost results will
      be tried to be determined.
    

Detailed description: 
      Detailed explanation will be made later if necessary.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients operated on for acute appendicitis
      
Keywords: Laparoscopic appendectomy; Hem-o-lok clip; stump closure
Dietary Advanced Glycation End Products and Migraine
Condition: Nutrition Disorders; Migraine Disorders
MeSH terms: Migraine Disorders; Nutrition Disorders
Study type: Observational

Summary: 
      Is dietary intake of advanced glycation different between individuals with and without
      migraine? Is there a difference between the groups in terms of energy and nutrients? The
      answers to these questions are sought.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adult individuals aged 19-64 who applied to Karabuk University Training and Research
        Hospital Neurology Clinic Headache Outpatient Clinic
A Multiple Dose Study to Evaluate the Effect of SHR-1222 Injection in Postmenopausal Osteoporosis Patients
Condition: Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Multi-Center, Randomized, Double-Blind, Dose Escalation, Placebo Parallel
      Controlled PhaseⅠClinical study to Evaluate the Safety, Tolerability and Pharmacokinetics,
      Pharmacodynamics, Immunogenicity with Multiple Subcutaneous Injections of SHR-1222 in
      Postmenopausal Osteoporosis Patients.

      The primary objective of this study is to investigate the safety and tolerability of a range
      of subcutaneous SHR-1222 in postmenopausal osteoporosis patients. Secondary objectives are to
      determine the pharmacokinetics (PK), pharmacodynamics (PD) profile of SHR-1222 in
      postmenopausal osteoporosis patients including assessment of immunogenicity.
    


Intervention name(s): SHR-1222; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: water injection Route of administration: subcutaneous injection; Pharmaceutical form: water injection Route of administration: subcutaneous injection
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Transversus Abdominis Plane Block With or Without Buprenorphine After Inguinal Hernia Surgery
Condition: Inguinal Hernia; Pain, Postoperative
MeSH terms: Hernia; Pain, Postoperative; Hernia, Inguinal
Study type: Interventional
Phase: Phase 1

Summary: 
      Buprenorphine intravenous, sublingual, and transdermal patches have been researched for their
      antihyperalgesic effects, although peripherally mediated effects have not been examined in
      Egypt surprisingly
    

Detailed description: 
      This prospective, randomized, double-blind controlled trial involved 88 patients who were
      scheduled for inguinal hernia surgery followed by a TAP block. Patients were allocated into
      group B (n= 44) received 20 ml of 0.25% Ropivacaine for TAP block; group BR (n= 44) received
      20 ml of 0.25% Ropivacaine containing 300 μg of buprenorphine for TAP Block. The primary
      outcome of the study was the analgesic and antihyperalgesic effect of buprenorphine compared
      to the control group. The duration of analgesia, analgesic consumption, postoperative pain
      scores at rest and sitting up to 48 hrs, and effect on wound hyperalgesia at 24 and 48 hrs
      were evaluated. Secondary outcomes of the study include incidence of side effects and TAP
      block-related complications were recorded. Effect of buprenorphine on patients with predicted
      high pain scores and incidence of persistent postoperative pain were also determined.

      A transversus abdominis plane (TAP) block provides analgesia of the anterior and lateral
      abdominal wall below the umbilicus by blocking the T6-L1 segmental nerves as they lie within
      the fascial plane between the transversus abdominis and internal oblique muscles: bilateral
      block for midline abdominal incision. It was first described in 2001 by Rafi as a traditional
      blind landmark technique using the lumbar triangle of Petit. Local anesthetic is then
      injected between the internal oblique and transverse abdominis muscles just deep the fascial
      plane, the plane through which the sensory nerves pass
    

Intervention name(s): Ropivacaine 0.25%-NaCl 0.9% Injectable Solution
Intervention type(s): Drug
Intervention description(s): The pain level of the cases is evaluated by means of the digital pain (numeric rating) scale from 0 to 10 in which 0 means "no pain" and 10 means "the worst pain" as well as the duration of pain relief and the need for another dose of the same analgesic or other. The pain level is evaluated again if it is present.
Other intervention name(s): buprenorphine 300 μg
Intervention MeSH terms: Buprenorphine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: to determine if TAP block treatment, either with or without buprenorphine, affected patients having inguinal hernias repaired
Masking: Single (Participant)
Primary purpose: Treatment
A Comparison Between the Intubating Laryngeal Tube Suction and the Ambu AuraGain
Condition: Difficult Intubation
Study type: Interventional

Summary: 
      The intubating Laryngeal Tube Suction-Disposable is a new version of the Laryngeal
      Tube-Suction. It has a ventilator channel with a 13.5mm internal diameter, which enables the
      passage of an Endotracheal Tube with fiberoptic guidance. This study was designed to assess
      the Time fiberoptic endotracheal intubation using iLTS-D, in comparison with the and Ambu®
      AuraGain™ in adult patients.
    

Detailed description: 
      The intubating Laryngeal Tube Suction-Disposable is a new version of the Laryngeal
      Tube-Suction. It has a ventilator channel with a 13.5mm internal diameter, which enables the
      passage of an Endotracheal Tube with fiberoptic guidance. This study was designed to assess
      the Time of fiberoptic endotracheal intubation using iLTS-D, in comparison with the and Ambu®
      AuraGain™ in adult patients.

      Detailed Description: The intubating Laryngeal Tube Suction-Disposable (iLTS-D) (VBM
      Medizintechnik GmbH, Sulz, Germany) is a new updated version of the Laryngeal Tube-Suction
      Disposable (LTS-D) It has a ventilator channel with a 13.5mm internal diameter, which enables
      the passage of an Endotracheal Tube (ETT) with fiberoptic guidance. Similarly as in to the
      LTS-D, the iLTS-D also has a separate channel for the purpose of placement of gastric tubes
      placement up to a size of 18 Fr.

      The iLTS-D comes in one size. According to the depth of insertion, this device is equivalent
      to size 4 for patients height 175 to 190 cm tall, or size 5 for patients taller than 190 cm.
      The iLTS-D is provided by the manufacturer with a compatible 7.5 mm ETT and with a plastic
      stabilizer for removal of the device.

      The current randomized study was designed to assess the success rate fiberoptic endotracheal
      intubation using iLTS-D, in comparison with the and Ambu® AuraGain™ in adult patients under
      general anesthesia
    

Intervention name(s): Intubating Laryngeal Tube Suction; Ambu AuraGain Laryngeal Mask
Intervention type(s): Device; Device
Intervention description(s): Intubating Laryngeal Tube Suction; Ambu AuraGain Laryngeal Mask
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: fiberoptic; supraglottic; Laryngeal Tube; intubation
Clinical Usability of Nasal Glucagon in Treatment of Hypoglycemia in Children and Adolescents
Condition: Hypoglycemia; Diabetes Mellitus
MeSH terms: Hypoglycemia
Study type: Interventional
Phase: Phase 3

Summary: 
      Up to fifty (50) children and adolescents with type 1 diabetes (T1D) aged 4 to ˂18 years at
      time of enrolment will be selected for inclusion in the study. The target is to obtain
      treatment response and user-experience data following use of Nasal Glucagon (LY900018) in
      treating episodes of hypoglycemia.
    

Detailed description: 
      This study is designed to evaluate the effectiveness of nasal glucagon (NG) administered
      under clinical use conditions in treating episodes of moderate or severe hypoglycemia in
      persons with T1D.

      This study also aims to assess the ease with which caregivers can administer the experimental
      medication in treatment of hypoglycemic events.
    

Intervention name(s): Nasal Glucagon
Intervention type(s): Drug
Intervention description(s): 3 mg nasal glucagon powder
Other intervention name(s): Dry-Mist nasal glucagon; AMG504-1; LY900018
Intervention MeSH terms: Glucagon; Glucagon-Like Peptide 1
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dexmedetomidine Versus General Anesthesia on the Diagnosis of Endobronchial US-Guided Transbronchial Needle Aspiration
Condition: Sedation; Dexmedetomidine; EBUS Guided Transbronchial Needle Aspiration
Study type: Interventional

Summary: 
      The aim of this study is to compare dexmedetomidine as moderate sedation versus general
      anathesia on the diagnostic yield of Endobronchial Ultrasound-Guided Transbronchial Needle
      Aspiration
    

Detailed description: 
      Endobronchial ultrasound (EBUS)-guided transbronchial needle aspiration (EBUS-TBNA) has
      emerged as a highly effective, minimally invasive technique for sampling peribronchial,
      mediastinal, and lung masses for pathologic examination with low rate of complications, and
      costs.

      Dexmedetomidine, is a high-affinity adrenergic agonist of the alpha 2 receptor, is a
      potential alternative sedative.

      The use of dexmedetomidine does not lead to respiratory depression, or to a decline in
      cognitive skills or patient cooperation. This is because dexmedetomidine acts on the alpha-2
      receptors in the locus coeruleus, in contrast to other sedatives (midazolam and propofol)
      which act on GABA receptors/cerebral cortex.
    

Intervention name(s): dexmedetomidine; general anesthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): patients will recieve moderate sedation by dexmedetomidine as study group; general anesthesia with neuromuscular blockade under controlled ventilation as control group.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Psychological, Physiological, Endocrine, and Pharmacokinetic Effects of LSD in a Controlled Study
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The purpose of this study is to characterize the acute psychological, physiological,
      endocrine, and pharmacokinetic, as well as long-term psychological effects of LSD in humans.
    

Detailed description: 
      Lysergic acid diethylamide (LSD) is the prototype hallucinogen used recreationally worldwide.
      In the 50-70s, LSD was also used to study psychotic-like states in normals ("model
      psychosis") and in "psycholytic psychotherapy". Potential research and therapeutic uses of
      LSD are now re-recognized and may include its use in brain research, treatment of cluster
      headache, and aid in psychotherapy and in terminally ill patients. A better and contemporary
      understanding of the pharmacology of LSD is important in the light of its widespread
      recreational, and potential scientific and therapeutic uses. The study has no primary
      therapeutic intentions but aims for a solid account of the clinical pharmacological
      characteristics of the drug. To characterize the acute physiological, psychological,
      endocrine, and pharmacological response to the administration of a single dose of LSD in
      healthy subjects the investigators use a randomized double-blind placebo-controlled
      cross-over design with two experimental sessions. Subjects will participate in a placebo and
      a LSD session. Subjective and cardiovascular responses will be repeatedly assessed throughout
      the experiments and plasma samples are collected for pharmacokinetics and endocrine
      measurements.Additionally long-term psychological changes associated with the LSD experience
      are assessed.
    

Intervention name(s): Placebo; LSD
Intervention type(s): Drug; Drug
Intervention description(s): Capsules containing mannitol looking identical to LSD
per os; 200µg per os, single dose
Other intervention name(s): Lysergic acid diethylamide
Intervention MeSH terms: Lysergic Acid Diethylamide
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: LSD; Pharmacology; Pharmacokinetics; Pharmacodynamics; Mechanism of action; Psychedelic; Serotonin; Prepulse inhibition; LSD-induced neuroendocrine effects; Long-term psychological effects
Computer Guided Versus Freehand Dental Implant Surgery
Condition: Dental Implant
Study type: Interventional

Summary: 
      This study's goal is to evaluate the efficacy of traditional rehabilitation with freehand
      implant implantation of partly or totally edentulous patients utilizing flapless or mini-flap
      procedures vs. 3D implant design software and specialized surgical templates.
    

Detailed description: 
      Patients with at least 7 mm of height and 4 mm of breadth in their bones, who needed at least
      two implants to be restored with a single prosthesis, were recruited one after the other.
      Patients were randomly assigned to two groups in a parallel group trial design. : Group I:
      consisted of 6 patients where computer guided dental implant placement and Group II: included
      six people who had dental implants placed manually. A temporary prosthesis was inserted into
      the implants right away, and four to six months later, a permanent prosthesis took its place.

      Implant failures, marginal bone loss, number of therapy sessions, length of treatment,
      post-surgical pain and swelling, use of painkillers, surgical time, time needed to resolve
      problems, and patient satisfaction were among the outcome variables evaluated by a blinded,
      independent assessor. Patients were tracked for a full year.
    

Intervention name(s): dental implant
Intervention type(s): Procedure
Intervention description(s): consisted of 6 patients where computer guided dental implant placement
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: virtual planning;; computer guided implants;; freehand implant;; dental implant