bioihbjkbjnl/mcl2 huggingface dataset:
Dexamethasone Added in Ultrasound-guided Transversus Abdominis Plain Block for Postoperative Analgesia
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      Dexamethasone Added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block
      Increased the Duration of Postoperative Analgesia After Laparoscopic Cholecystectomy.
    

Detailed description: 
      In the ultrasound-guided TAP-Block with Dexamethasone group, dexamethasone is added to
      Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block after Laparoscopic
      Cholecystectomy. In the ultrasound-guided TAP-Block with saline group, saline is added to
      Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block , after Laparoscopic
      Cholecystectomy. In the ultrasound-guided TAP-Block with intravenously dexamethasone group,
      dexamethasone is intravenously injected , after Laparoscopic Cholecystectomy. After surgery
      the extension of postoperative analgesia, incident and rest pain were evaluate in each group.
    

Intervention name(s): TAP Block and Dexamethasone; TAP Block and saline; TAP Block and Dexamethasone i.v.
Intervention type(s): Procedure; Other; Drug
Intervention description(s): After general anesthesia and before the beginning of surgery, the ultrasound-guided is performed between the internal oblique muscle and the transversus abdominis muscle and dexamethasone is added to levopubivacaine; After general anesthesia and before the beginning of surgery, the ultrasound-guided is performed between the internal oblique muscle and the transversus abdominis muscle and saline is added to levopubivacaine; After general anesthesia and before the beginning of surgery, the ultrasound-guided is performed between the internal oblique muscle and the transversus abdominis muscle and dexamethasone is injected intravenously
Other intervention name(s): TAP-Block under ultrasound guidance and dexamethasone; TAP-Block under ultrasound guidance and saline; TAP-Block under ultrasound guidance and i.v. dexamethasone
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Analgesia; Dexamethasone; Levobupivacaine; Ultrasound-guided; Tranversus Abdominis
Calcineurin Inhibitor Avoidance With Thymoglobulin and Sirolimus in Kidney Transplantation
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      A prospective, single center, open-label, randomized trial of Thymoglobulin induction and
      sirolimus, prednisone, and mycophenolate mofetil versus Thymoglobulin induction and
      tacrolimus, prednisone, and mycophenolate mofetil in non-HLA identical living or deceased
      donor kidney transplant recipients.
    

Detailed description: 
      Calcineurin inhibitor-associated nephrotoxicity may exacerbate chronic allograft nephropathy
      and reduce long-term kidney graft survival. Complete avoidance of calcineurin inhibitors may
      improve graft function as measured by serum creatinine and calculated GFR and improve
      long-term outcomes following kidney transplantation. We conducted a prospective, randomized,
      single-center study comparing sirolimus versus tacrolimus in kidney transplantation. Primary
      cadaver of non-HLA identical living donor recipients are randomized to received either
      sirolimus 5 mg QD (target level 8-12 ng/ml) or tacrolimus 0.075 mg/kg BID (target level 8-12
      ng/ml). All patients also received Thymoglobulin 1.5 mg/kg x 4 doses, mycophenolate 1 gm BID,
      and prednisone. Main outcome measures are patient and graft survival, biopsy-proven acute
      rejection, serum creatinine, hyperlipidemia, post-transplant diabetes, and surgical and wound
      complications.
    

Intervention name(s): Sirolimus
Intervention type(s): Drug
Intervention MeSH terms: Sirolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kidney transplantation; immunosuppression; sirolimus; Thymoglobulin
Brain Penetrance of 2-HOBA in Humans
Condition: Healthy Adults
Study type: Interventional

Summary: 
      The purpose of this study is to confirm that 2-HOBA crosses the blood brain barrier and to
      compare blood and cerebrospinal fluid levels of 2-HOBA after a single oral dose.
    

Detailed description: 
      Consenting volunteers between 40 and 70 years old with no morbidity, including males, and
      females who are not pregnant will be recruited for the study. Three volunteers will be
      enrolled with a reasonable sampling of ethnicities from the Nashville area, and an effort
      will be made to recruit males and females. The study will be conducted by the Vanderbilt
      Clinical Research Center (CRC).

      Briefly, the three volunteers will be studied at a single dose level. Baseline assessments
      will be performed, and then each volunteer will be given a single oral dose (550 mg) of
      2-HOBA. Ninety minutes after the dose, a lumbar puncture will be performed to obtain
      cerebrospinal fluid and a blood sample will be collected. 2-HOBA levels will be measured in
      cerebrospinal fluid and blood samples from this timepoint to assess the ability or orally
      ingested 2-HOBA to cross the blood brain barrier.
    

Intervention name(s): 2-HOBA
Intervention type(s): Dietary Supplement
Intervention description(s): 2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate
Other intervention name(s): 2-Hydroxybenzylamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Multiple Dosage
Exercise as an Adjuvant to Aphasia Therapy
Condition: Aphasia
MeSH terms: Aphasia
Study type: Interventional

Summary: 
      The purpose of the study is to reveal if individuals who participate in aerobic activity
      demonstrate greater improvement in language abilities than patients who do not participate in
      aerobic activity.
    

Detailed description: 
      The objective of this research project is to reveal if individuals who participate in aerobic
      activity demonstrate greater improvement in language abilities with treatment than patients
      who do not participate in aerobic activity. As secondary objectives, we will determine if
      there is a direct relationship between either brain efficiency or increases in Brain Derived
      Neurotrophic Factor (BDNF) after exercise and higher learning rates in aphasia.
    

Intervention name(s): Aerobic exercise; Stretching
Intervention type(s): Behavioral; Behavioral
Intervention description(s): An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.; Stretching will occur for 50 minutes a day, three days/week for 12 weeks.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The study used a single-subject, multiple-baseline design across behaviors. Following assessment and baseline procedures, participants completed 2 therapy periods: Block 1 was aphasia therapy alone, and Block 2 was aphasia therapy plus aerobic exercise or stretching.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rehabilitation; aphasia; exercise; BDNF
Oral Vitamin D Supplementation in Elderly Women
Condition: Optimal Vitamin D Administration
Study type: Interventional

Summary: 
      The aim of this study is to compare oral vitamin D supplementation administered in two
      different ways, namely either twice a day (800IU/d, 292000IU/y) or three times a year
      (97333IU every 4 months, 292000IU/y) in elderly women in combination with daily
      supplementation of calcium 1 gram. We will 1)compare the blood concentrations of 25 OH
      vitamin D in the two treatment groups amd monitor if a sufficient and safe concentration of
      25OH D in blood can be maintained with these two treatments.2) Find out seasonal variation in
      vitamin D concentrations in these treatments. 3) Find out safety of these treatments
    


Intervention name(s): vitamin D twice daily; Vitamin D3 oil three times in a year
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Kalsipos-D, vitamin D3 400 ID/tbl, 2 tbl/day for one year; Vigantol oil , D3 20000IU/ml, 4.9 ml every four months for one year
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: vitamin D; seasonal variation; PTH; bone markers
Study of Breast Cancer Prevention by Letrozole in High Risk Women
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-institution double-blind placebo-controlled trial whose main objective is to
      determine if 6 months of letrozole (2.5 mg daily) can reduce proliferation as assessed by
      Ki-67 in high risk postmenopausal women on systemic hormone replacement therapy who have
      random periareolar fine needle aspiration (RPFNA) evidence of hyperplasia with atypia or
      borderline atypia, and a minimum Ki-67 of >1.5%.

      The primary hypothesis is that proliferation and expression of other estrogen response genes
      will be favorably modulated by six months of letrozole relative to placebo without
      substantially increasing hot flashes or worsening overall quality of life.
    

Detailed description: 
      Subsequent to the 6 month RPFNA for assessment of biomarkers, toxicity and quality of life
      assessments, all women may receive optional open-label letrozole for an additional 6 months,
      followed by a third RPFNA and biomarker
    

Intervention name(s): Letrozole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Letrozole 2.5 mg tablet daily. Then optional open label letrozole for another 6 months.; Placebo tablet daily for 6 months then optional open label letrozole for 6 months.
Other intervention name(s): Letrozole(Femara)
Intervention MeSH terms: Letrozole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Efficacy and Safety of Nemonoxacin vs Levofloxacin in Adult Patients With Community-Acquired Pneumonia
Condition: Pneumonia, Bacterial
MeSH terms: Pneumonia; Pneumonia, Bacterial
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study was to evaluate the clinical efficacy of treatment with
      Nemonoxacin compared with Tavanic® in patients with community-acquired pneumonia (CAP).
    

Detailed description: 
      Treatment-naive patients with CAP and patients with treatment failure were screened and if
      met the eligible criteria were randomized to receive either treatment with investigational
      product or comparator. Patients started to receive intravenous therapy with Nemonoxacin or
      Tavanic® and then upon a decision of investigator patients were switched to oral therapy with
      the same product.

      Intravenous therapy included two consequence infusions (antibiotic solution and placebo
      solution) to maintain blinding. Intravenous therapy should have been given for at least 3
      days and could have been prolonged by a decision of investigator up to 7 days. Then
      investigator switched a patient from intravenous to oral therapy on Day 4(8) of the study if
      the specific criteria of clinical stability were achieved. To maintain blinding during oral
      antibiotic therapy each Tavanic® tablet was placed into a capsule shell (over-encapsulated),
      that was identical in appearance to a Nemonoxacin-containing capsules.

      The average duration of treatment (including intravenous and oral therapy) for each patient
      was 7(14) days and during this period patients should have stayed at hospital. After
      completion of the treatment patients could have been discharged from the hospital and
      returned for examinations within 1-2 days after the last dose (end of treatment visit). Then
      the patients attended the investigational site within 7-9 days after the last dose (test of
      cure visit). Then the investigator contacted the patients by phone within 21-23 days after
      the last dose (long-term follow-up visit).
    

Intervention name(s): Nemonoxacin; Nemonoxacin; Tavanic; Tavanic; Placebo (250 ml); Placebo (100 ml)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Solution for infusion, 500 mg (250 ml); Capsules, 250 mg; Solution for infusion, 500 mg (100 ml); Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg; 0.9% NaCl (250 ml), solution for infusion; 0.9% NaCl (100 ml), solution for infusion
Other intervention name(s): Levofloxacin; Levofloxacin
Intervention MeSH terms: Levofloxacin; Ofloxacin; Nemonoxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All eligible patients will be randomized to receive either treatment with Nemonoxacin or Tavanic® in a ratio of 1:1.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: nemonoxacin; community-acquired pneumonia; quinolones
Aspiration of Excessive Endometrial Fluid at the Day of Ovum Retrieval Plus Diosmin in (ICSI) Cycles
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      To notify the effect of aspiration of excessive endometrial fluid in addition to Diosmin in
      cases undergoing intracytoplasmic sperm injection (ICSI) cycles.
    

Detailed description: 
      Objectives: To notify the effect of aspiration of excessive endometrial fluid in addition to
      Diosmin in cases undergoing intracytoplasmic sperm injection (ICSI) cycles.

      Study design: Prospective randomized controlled clinical trial.

      Patients and Methods: 200 women with excessive endometrial fluid by transvaginal ultrasound
      during ICSI cycles are randomly scheduled into two equal groups. In group A, one tab every 8
      hs Diosmin ( 500mg) beginning from the day of ovum retrieval in addition to aspiration of the
      fluid by an IUI catheter ; while in group B (control group), no thing is given or done. The
      main outcome measures are presence of the fluid on the day of embryo transfer and the
      pregnancy rate on those patients.
    

Intervention name(s): group A
Intervention type(s): Other
Intervention description(s): one tab every 8 hs Diosmin ( 500mg) beginning from the day of ovum retrieval in addition to aspiration of the fluid by an IUI catheter
Other intervention name(s): Daflon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Cognitive Effects of Oral Oxybutynin and Oxybutynin Chloride Topical Gel in Older Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to explore the possible cognitive effects of oxybutynin tablets
      and oxybutynin gel.
    


Intervention name(s): oxybutynin chloride immediate-release; oxybutynin chloride topical gel; placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): capsule containing oxybutynin chloride immediate-release 5 mg tablet administered three times daily, and placebo gel administered once daily; oxybutynin chloride topical gel applied once daily, and capsule containing placebo tablet administered three times daily; capsule containing placebo tablet administered three times daily, and placebo gel administered once daily
Intervention MeSH terms: Mandelic Acids; Oxybutynin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
To Evaluate the Impact of Treatment Interruption on Re-initiation of Bifeprunox
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate a safe treatment interruption interval(s) for
      re-initiation of bifeprunox at a therapeutic dose. The study duration is approximately 7 to
      10 weeks.
    


Intervention name(s): Bifeprunox
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Treatment interruption on reinitiation; Schizophrenia; Schizoaffective disorder
Efficacy of New Alcohol Free Mouthrinses
Condition: Gum Disease
MeSH terms: Gingival Diseases; Periodontal Diseases
Study type: Interventional

Summary: 
      Background To evaluate the efficacy of two alcohol-free antimicrobial mouthrinses in reducing
      plaque and gingivitis compared to an alcohol-containing rinse and toothbrushing alone.

      Methods 160 healthy volunteers were enrolled in the parallel-design examiner-blind study.
      After screening and stratification by sex and papillary bleeding index (PBI), participants
      were randomly and equally assigned to four groups: (1) toothbrushing + rinsing (0.06% CHX +
      0.025% NaF, alcohol-containing rinse, Corsodyl® Daily Defence Mouthwash; positive control);
      (2) toothbrushing + rinsing (0.06% CHX + 0.025% NaF, alcohol-free experimental rinse); (3)
      toothbrushing + rinsing (0.06% CHX + 0.03% CPC + 0.025% NaF, alcohol-free experimental
      rinse); (4) toothbrushing alone (negative control). At baseline, Quigley-Hein plaque index
      (QHI), the modified proximal plaque index (MPPI), and PBI were recorded. All subjects were
      advised to brush their teeth as usual during the eight weeks study period. Additionally,
      groups 1-3 were instructed to rinse twice daily (30 sec. each). All participants used Dr.
      Best multi aktiv toothpaste and Dr. Best plus toothbrush (medium stiffness). Eight weeks
      after baseline, indices were recorded again. Anova with Bonferroni adjustment was used for
      statistical analysis.
    


Intervention name(s): alcohol-free experimental mouth rinse; alcohol-containing mouth rinsing
Intervention type(s): Other; Other
Intervention MeSH terms: Ethanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
A Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis
Condition: Osteoporosis in Men
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is designed to evaluate if treatment with romosozumab once a month for 12 months
      compared with placebo is effective in increasing bone mineral density (BMD) at the lumbar
      spine. Additionally, the study will assess the effect of treatment with romosozumab for 12
      months compared with placebo on BMD at the femoral neck and total hip.
    


Intervention name(s): Romosozumab; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): Administered by subcutaneous injection once a month.; Administered by subcutaneous injection once a month.
Other intervention name(s): AMG 785; EVENITY™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Osteoporosis in men
Dyslipidemia-related Risk Factors in Dialysis
Condition: Chronic Renal Disease; Cardiovascular Disease; Dyslipidemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Cardiovascular Diseases; Dyslipidemias
Study type: Observational

Summary: 
      In this study, we studied lipoprotein abnormalities-related variables as risk factors for the
      development of cardiovascular disease in patients on renal replacement therapies.We studied
      96 dialyzed patients, 62 males and 34 females, on mean age 62.1 years old and 24 healthy
      controls.We concluded that metabolic acidosis activating the inflammation and lipoprotein
      oxidation influences the dyslipidemia and cardiovascular morbidity of patients on renal
      replacement therapies.Dialysis adequacy was positively associated to cardioprotective
      HDL.Peritoneal dialysis holds a better acidosis level and lower oxidized lipids than
      hemodialysis modalities.
    

Detailed description: 
      Blood samples were obtained by venipuncture in the peritoneal dialyzed patients and control
      group in a twelve hours fasting state.In hemodialyzed patients blood was drawn just before
      the start of the mean weekly dialysis session also in a twelve hours fasting state from the
      vascular access.

      All samples were received once at baseline time ( in the start of the study ). Peripheral
      systolic and diastolic blood pressures were calculated as an average of 10 measurements
      during a renal replacement treatment month in the starting time of the study.

      Also, electrocardiographic examination, echocardiography and the calculation of
      ankle-brachial blood pressure index became once in the start of the study.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        We studied 96 dialyzed patients at Nephrology Department of "Laiko, University General
        Hospital of Athens" and Renal Unit of "Diagnostic and Therapeutic Center of Athens Hygeia
        SA". 62 males and 34 females participated in this study.The treatment modalities which were
        applied were : regular haemodialysis (HD, n=34), predilution haemodiafiltration (HDF, n=42)
        and peritoneal dialysis (PD, n=20).
      
Keywords: hemodialysis, dyslipidemia, cardiovascular disease
A Safety and Pharmakokinetic Study of A4250 Alone or in Combination With A3384
Condition: Orphan Cholestatic Liver Diseases; Primary Biliary Cirrhosis; Progressive Familial Intrahepatic Cholestasis; Alagille Syndrome
MeSH terms: Liver Diseases; Cholestasis; Liver Cirrhosis, Biliary; Cholestasis, Intrahepatic; Alagille Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of the study are to evaluate the safety, tolerability and
      pharmacokinetics of A4250 after single or multiple oral doses in healthy subjects. In
      addition, will evaluate A4250 in combination with cholestyramine.
    


Intervention name(s): A4250; CRC (A3384); Questran; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Cholestyramine Resin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment