bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 2 Study to Evaluate the Efficacy and Safety of TNX-102 SL in Patients With Multi-Site Pain Associated With Post-Acute Sequelae of SARS-CoV-2 Infection
Condition: Post-Acute Sequelae of SARS-CoV-2 (PASC) Infection; COVID-19; Long COVID; Long Haul COVID
MeSH terms: Infections; Communicable Diseases; COVID-19; Post-Acute COVID-19 Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, randomized, parallel-group, double-blind, placebo-controlled, 14-week
      study designed to evaluate the efficacy and safety of TNX-102 SL 5.6 mg (2 x 2.8 mg tablets)
      taken once daily at bedtime for the management of multi-site pain associated with Long COVID.
    


Intervention name(s): TNX-102 SL; Placebo SL Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.; Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multi-site pain; Sleep disturbance; PASC; COVID-19; Long COVID; Coronavirus infections
Comparison of Tramadol Orally Versus an Optimized Dose of Intravenous Tramadol for Postoperative Pain Relief in Ambulatory Surgery
Condition: Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the administration of 1 unit dose of 50 mg tramadol
      perorally given in 3 unit dosages versus tramadol IV given in 3 unit dosage of 35 mg during
      the first 6 hours postoperatively and to investigate the time course and accuracy of pain
      relief versus the onset and duration of side effects. The first unit dose will be
      administered at arrival at the PACU when a Visual Analogue Pain (VAS) score of more than 3 is
      reached. The second and third unit dose will be administered after 1 and 2 hours,
      respectively, when a VAS of more than 3 is observed.
    


Intervention name(s): Tramadol per os (Tradonal Odis® orodispersible tablets); Tramadol IV (Tradonal® IV)
Intervention type(s): Drug; Drug
Intervention description(s): Administration of 1 unit dose of 50 mg tramadol perorally given in 3 unit dosages; Administration of tramadol IV given in 3 unit dosage of 35 mg
Intervention MeSH terms: Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Patients who will undergo a general anesthesia for a procedure in short stay
Abuse Potential of Single Doses of Lorcaserin in Healthy Recreational Polydrug Users
Condition: Drug Abuse; Healthy
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the abuse potential of lorcaserin in healthy
      recreational polydrug users.
    


Intervention name(s): Placebo; Active Comparator #1; Active Comparator #2; Active Comparator #3; Lorcaserin Dose #1; Lorcaserin Dose #2; Lorcaserin Dose #3
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Abuse potential
Effect of KYG0395 on Primary Dysmenorrhea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to further assess the efficacy, safety and dose-response of
      KYG0395 in the treatment of primary dysmenorrhea.
    

Detailed description: 
      Compare the effect and safety of the investigational drug and placebo on dysmenorrhea in
      adult otherwise healthy women.
    

Intervention name(s): high dose KYG0395; lower dose KYG0395; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3 KYG0395 capsules tid (morning, midday, and evening); 3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday); 3 capsules of placebo tid (morning, midday, and evening)
Other intervention name(s): KYG0395 high dose; KYG0395 low dose; Placebo oral capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Noninterventional Genotype/Phenotype Study of mGluR Mutations in Children and Adolescents With ADHD
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      This noninterventional study will assess genomic changes in the metabotropic glutamate
      receptor (mGluR) network in children and adolescents with ADHD.
    

Detailed description: 
      Male and female subjects 6 to 17 years of age with a primary psychiatric diagnosis of ADHD
      will be enrolled in this study. The subject and his or her parent/guardian must agree to
      genotyping to determine whether the subject has disruptive mutations within any of the
      approximately 274 mGluR-network genes, and complete an interview that will include
      information about the subject's ADHD history, treatment, and co-morbidities.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Subjects between the ages of 6 years and 17 years of age with a previously established
        diagnosis of ADHD will be eligible for screening.
      
Biospecimen description: 
      Saliva
Stress and Gingival Inflammation in Non-pregnant and Pregnant Women
Condition: Periodontal Diseases; Pregnancy Gingivitis
MeSH terms: Gingivitis; Periodontal Diseases; Inflammation
Study type: Interventional

Summary: 
      Background: The purpose of the present study is to research whether stress scale scores alter
      with relationship to gingival inflammation and examine the impact of non-surgical periodontal
      therapy during pregnancy on the levels of cytokines in gingival crevicular fluid (GCF) and on
      salivary stress-related hormones.

      Methods: 30 non-pregnant (control group) and 30 pregnant women (test group) who fulfilled the
      study inclusion criteria were chosen. The participants with moderate/severe gingivitis were
      included. Clinical data and samples of GCF and salivary were collected at baseline and after
      periodontal therapy. The levels of cytokines interleukin-1 beta (IL-1β) and IL-10, and
      concentration of salivary chromogranin A (Cg A) hormone were analyzed by enzyme-linked
      immunosorbent assay kits.
    

Detailed description: 
      Periodontal clinical measurements and periodontal treatment were applied by a previously
      trained and calibrated examiner. Clinical parameters measurements including; probing pocket
      depths (PPD; the distance from the gingival margin to the base of the gingival sulcus),
      clinical attachment level (CAL), full mouth gingival index (GI)21 and plaque index (PI)20
      scores using a periodontal probe were registered following saliva and GCF sample collection.
      Then, non-surgical periodontal therapy (NPT) consisted of scaling, root planning, and oral
      hygiene instruction was applied. Clinical measurements, recruitment of GCF, and saliva
      samples were repeated after three weeks.

      Gingival Crevicular Fluid and Saliva Sample Collection Selected anterior teeth for GCF
      sampling were isolated from saliva using cotton rolls, a gentle stream of air was conducted
      parallel to the root surface for 5 to 10 seconds to dry the area.

      The periopaper strips were gently inserted into the gingival crevice until resistance was
      felt and were left in place for 30 s and were collected from mesio-buccal sulcus of teeth in
      the anterior region of each patient (two samples per patient and per visit). The samples
      containing blood were discarded and were placed in sterile Eppendorf tubes and were stored at
      -20°C until the assay procedure.
    

Intervention name(s): periodontal treatment
Intervention type(s): Procedure
Intervention description(s): non-surgical periodontal therapy (NPT) consisted of scaling, root planning, and oral hygiene instruction
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: chromogranin A, stress, gingivitis, pregnancy
Effectiveness of Parenting Programs on Child Development and Maternal Well-being in Rural Uganda
Condition: Child Development; Depression
MeSH terms: Depression
Study type: Interventional

Summary: 
      The purpose of the current study involves the development, implementation and evaluation of a
      parenting program to target maternal well-being and child health, growth and development in
      Lira, Uganda. The current study aims to address maternal care within a parenting program as
      well as parenting practices emphasizing nutrition, hygiene, and psychosocial stimulation
      through peer-support, practice and problem-solving. Outcomes include child health, growth and
      development, maternal mental health, mother-child interactions, and maternal-spousal
      relations.

      We hypothesize that:

        1. Children of parents who attend the parenting program will have better health, height and
           cognitive/language development at post-test, than children whose parents did not have
           the opportunity to attend parenting sessions.

        2. Parents who attend the parenting program will have more knowledge about child
           development and provide more home stimulation, dietary diversity and preventive health
           practices than parents who do not have the opportunity to attend parenting sessions.

        3. Mothers who attend the parenting program will have improved well-being compared to
           mothers who do not have the opportunity to attend parenting sessions.
    


Intervention name(s): Parenting Program
Intervention type(s): Behavioral
Intervention description(s): A manualized, community-based 12 session group parenting program, facilitated by a locally recruited volunteer
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: child nutritional status; child development; maternal depression
Evaluation of Preimplantation Portal Vein and Hepatic Artery Flushing With Tacrolimus
Condition: Early Allograft Dysfunction; Ischemic Reperfusion Injury; Liver Transplantation; Hyperfibrinolysis
MeSH terms: Reperfusion Injury; Flushing
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the Tacrolimus added to
      histidine-tryptophan-ketoglutarate (HTK) solution given through intraportal and intraarterial
      infusion during back-table procedure is capable of reducing the degree of early allograft
      liver dysfunction, as assessed by postoperative levels of aspartate aminotransferase (AST),
      alanine aminotransferase (ALT), during first 7 postoperative days and by serum and
      histochemical markers of liver injury and inflammation.
    

Detailed description: 
      Early allograft liver dysfunction remains a significant complication of cadaveric liver
      transplantation with resource consuming and costly treatment, increased risk of multiorgan
      failure and 6-months mortality.

      Ischemic reperfusion injury (IRI) is a main reason for early allograft liver dysfunction.
      Inflammatory response to brain death in donor can precipitate the extent of dysfunction after
      reperfusion in recipient (1). Clear inflammatory pathways in response to IRI have been
      reported to be associated with early allograft liver dysfunction (2,3). It was shown that ex
      vivo intraportal tacrolimus perfusion suppressed inflammation and immune response in the
      transplanted liver on a genome-wide basis (4).

      We hypothesize that Tacrolimus added to HTK solution given through intraportal and
      intraarterial back-table infusion is capable of reducing the degree of early allograft liver
      dysfunction, as assessed by incidence of postreperfusion hyperfibrinolysis, postoperative
      levels of AST,ALT, during 1-7 postoperative days as well as serum and histochemical markers
      of liver injury and inflammation compared to no intraportal and intraarterial back-table
      infusion.
    

Intervention name(s): Tacrolimus
Intervention type(s): Drug
Intervention description(s): 1000 ml of HTK solution (Custodiol, Dr. Franz Köhler Chemie GmBH) cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O.
Other intervention name(s): Tacrolimus, Astellas Pharma Europe; Custodiol, Dr. Franz Köhler Chemie GmBH
Intervention MeSH terms: Tacrolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Liver transplantation; Early allograft dysfunction; Ischemic reperfusion injury; Portal and arterial ex vivo HTK flush
Post Acute Coronary Event Smoking Study
Condition: Smoking Cessation; Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome
Study type: Interventional

Summary: 
      Smoking and depressed mood are both predictive of mortality following Acute Coronary
      Syndrome. However, to date, no counseling treatment has been designed to target smoking
      cessation and manage mood in this population. This trial will test such a treatment based on
      Behavioral Activation, an approach that has shown promise as an integrated treatment for
      smoking and mood management in other populations.
    

Detailed description: 
      The occurrence of Acute Coronary Syndrome (ACS; unstable angina, ST and non-ST elevation
      myocardial infarction) can be conceptualized as a "teachable moment," whereby patients may be
      more receptive to smoking cessation messages. Continued smoking following ACS is an
      independent predictor of mortality. Depressed mood post-ACS is also predictive of mortality,
      and smokers with depressed mood are less likely to abstain from smoking following an ACS
      hospitalization. Thus, a single, integrated treatment that targets both depressed mood and
      smoking could be highly effective in reducing post-ACS mortality. Behavioral Activation (BA)
      may be an ideal treatment for this population as BA can easily integrate both mood and
      smoking cessation related goals and it focuses on addressing restriction of valued
      activities, which is common in the post-ACS population.

      Thus, the overall aim of the current study is test a BA treatment manual that integrates
      smoking cessation and mood management for post-ACS smokers (Behavioral Activation Treatment
      for cardiac patients who smoke; BAT-CS). We will conduct an RCT (N=72) comparing BAT-CS (1
      in-hospital session and 5-9 post-discharge sessions) to Standard Care (SC; 1 in-hospital
      session and 5 mailed packets of printed self-help materials). Differences in smoking
      cessation, depressed mood, and positive affect will be compared between conditions.
    

Intervention name(s): Behavioral Activation (BA); Standard Smoking Cessation Counseling; Nicotine patch; Printed Self-help materials for Smoking Cessation
Intervention type(s): Behavioral; Behavioral; Drug; Other
Intervention description(s): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.; 1 hour of in hospital counseling based on clinical guidelines; An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Smoking; Mood Management; Depression; Behavioral Activation; Acute Coronary Syndrome; Myocardial Infarction
Weight Loss Study-Mechanism Underlying the Improvement of Insulin Resistance in Response to Weight Loss
Condition: Obesity; Weight Loss
MeSH terms: Insulin Resistance; Body Weight; Weight Loss
Study type: Interventional

Summary: 
      The main purpose of this study is to assess factors mediating the changes in insulin
      sensitivity and glucose tolerance before and after 10 lbs ± or 2% weight loss reduction as
      well as 2, 3, 6, 12, and 24 months after initiation of a low calorie diet.

      The investigators will also study the following:

        1. The impact of diet induced weight loss on hormones/adipokine levels

        2. The impact of diet induced weight loss on leptin tolerance
    


Intervention name(s): Weight loss group (Full meal replacement products)
Intervention type(s): Dietary Supplement
Intervention description(s): In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase
Other intervention name(s): Full meal replacement products (1280-1320 kcal/day)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Overweight; Obesity; Obese; Weight loss
Single Rising Peroral Doses of BI 1744 CL in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to investigate safety, tolerability, and pharmacokinetics of single rising peroral
      doses of BI 1744 CL.
    


Intervention name(s): BI 1744 CL; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Olodaterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Effect of Pursed-Lip Breathing on Blood Pressure and Heart Rate
Condition: Hypertensive Urgency
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      Hypertensive urgency (HT urgency) is an alarm sign of uncontrolled hypertension. It can be
      aggravated by nonadherent to medication and psychosocial stress. Mindfulness is beneficial
      for reducing stress, while deep and slow breathing is effective for blood pressure (BP)
      lowering. The objective of the study was to assess the effect of pursed-lip breathing with
      number counting (PLB with NC) that promotes mindfulness and a deep/slow breathing pattern on
      BP and heart rate (HR) in the HT urgency patients.
    

Detailed description: 
      This was a single-blinded randomized controlled trial. Patients aged between 18-80 years old,
      diagnosed with HT urgency, who presented at the emergency room of Srinagarind hospital (a
      1000-bed, tertiary-care level university hospital), Khon Kaen University between September
      1st, 2019 to June 30th, 2020, were enrolled. Those with cardiac arrhythmias, acute HF, acute
      coronary syndromes, acute stroke, acute respiratory failure, alteration of consciousness, and
      pregnant women were excluded. This study was approved by the Khon Kaen University Ethical
      Review Board in Human Research (HE611586). All patients gave their written informed consent
      before the enrollment.HT urgency was defined as SBP >180 mmHg and/or DBP >110 mmHg without
      any signs or symptoms of target organ damages.
    

Intervention name(s): Non-pharmacologic treatment; Pursed-Lip Breathing Combined with Number Counting
Intervention type(s): Other
Intervention description(s): Pursed-lip breathing and number counting "one and two" during inspiration, and then number counting, "one, two, three, and four" during exhalation. The nurse advised the patient to continue pursed-lip breathing with number counting for the first 15 minutes (min) of each hour to prevent the patient from being exhausted, total study time was 3 hours, or until the patient was discharged from the ER, or was withdrawn from the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a single-blinded randomized controlled trial.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypertensive crisis; Uncontrolled hypertension; Mindfulness; Slow breathing; Emergency room
Chronic Dosing Cross-Over Study to Assess the Efficacy and Safety of Glycopyrronium (PT001) in Adult Subjects With Intermittent Asthma or Mild to Moderate Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      A Randomized, Double-Blind, Chronic Dosing (14 days), 5-Period, 7-Treatment,
      Placebo-Controlled, Incomplete Block, Cross-Over, Multi-center, Dose-ranging Study to Assess
      the Efficacy and Safety of Glycopyrronium MDI (PT001) Relative to Placebo MDI and Open-Label
      Serevent Diskus in Adult Subjects With Intermittent Asthma or Mild to Moderate Persistent
      Asthma
    


Intervention name(s): Glycopyrronium MDI; Serevent Diskus 50 μg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): GP MDI
Intervention MeSH terms: Glycopyrrolate; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment