bioihbjkbjnl/mcl2 huggingface dataset:
Does Coronary Angiography Cause Cognitive Dysfunction?
Condition: Coronary Heart Disease; Heart Valve Diseases
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Heart Valve Diseases
Study type: Observational

Summary: 
      The purpose of the study is to study if coronary angiography cause cognitive dysfunction.
    

Detailed description: 
      We have previously shown, using transcranial doppler, that coronary angiography cause
      cerebral microembolism. Cerebral microemboli were more common using the radial than femoral
      approach. Previously, cerebral microembolism has been associated with new cerebral lesions on
      MRI. The clinical significance of these new lesions is not determined. The primary aim of
      this pilot study is to see if coronary angiography cause cognitive dysfunction determined by
      the MoCA-test. A secondary aim is to relate cognitive dysfunction to cerebral microembolism
      measured by transcranial doppler. A third aim is to study potential differences between the
      femoral and radial approaches.
    

Intervention name(s): Arterial approach
Intervention type(s): Procedure
Intervention description(s): Randomization to right radial or femoral approach
Other intervention name(s): Coronary arteriography
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients scheduled for elective coronary angiography at one center
The Effects of IASTM and Proprioception
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The research design will be single group pretest-posttest design. The subject will be
      instructed to position the knee joint to a position previously set by the experimenter.
      Intervention will be 10 minutes of GT1 instrument application at anterior thigh using sweep
      technique.
    


Intervention name(s): Instrument Assisted Soft Tissue Mobilization
Intervention type(s): Other
Intervention description(s): Intervention will be 10 minutes of GT1 instrument application at anterior thigh using sweep technique.
Other intervention name(s): IASTM
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Effectiveness and Safety Study of CONCERTA* vs. Immediate Release Methylphenidate (IR MPH) in Attention Deficit Hyperactivity Disorder Children
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the effectiveness and safety of
      OROS*methylphenidate/CONCERTA* vs. immediate release methylphenidate as a treatment for ADHD
      specifically for those children who have behavioural difficulties in the
      afternoon/after-school and evening periods.
    

Detailed description: 
      Methylphenidate, namely immediate release methylphenidate is the primary stimulant used in
      the treatment of children with Attention Deficit Hyperactivity Disorder (ADHD). Immediate
      release methylphenidate has limitations related to its time course of action.As the morning
      dose wears off, inattention may increase during late-morning classes. Similarly, when the
      midday dose is wearing off, the child may experience difficulty concentrating on homework.
      The second problem relates to compliance with midday and late afternoon dosing. Children feel
      stigmatized or embarrassed by trips to the nurse's office for medication and may skip doses
      as a result. In other cases, a school nurse may not be available or policies prohibit staff
      from administering drugs so children may be required to self-administer drug. CONCERTA® was
      developed to overcome these limitations. The purpose of this study is to see how effective
      and safe Concerta* is vs. immediate release methylphenidate in children with ADHD.

      Patients will take either Concerta* (18, 27, 36, or 54 mg) or Immediate Release
      Methylphenidate tablets (maximum 60mg/day) orally every morning for 8 weeks.
    

Intervention name(s): OROS*-Methylphenidate
Intervention type(s): Drug
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder; OROS* Methylphenidate
Effect of Visceral Manipulation on PCOS
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The study was conducted to determine the effect of visceral manipulation on menstrual
      irregularities and hormonal profile in women with polycystic ovarian syndrome. Thirty women
      were randomly and equally assigned into the group (A) (Control group), who received a low
      caloric diet (1200 Kcal/day) only for 3 months, and the group (B) (Study group), who received
      visceral manipulation to the pelvic organs and the related structures in addition to the same
      low-calorie diet as the group (A). Evaluations pre and post-study were done for body weight,
      BMI, female reproductive hormones, and menstruation-related problems.
    

Detailed description: 
      The current study was conducted to determine the effect of visceral manipulation on menstrual
      irregularities and hormonal profile in women with polycystic ovarian syndrome (PCOS). Thirty
      women having PCOS were chosen from the outpatient clinic of the faculty of physical therapy,
      Cairo University. Patients were randomly assigned into two groups equal in number. Group (A)
      (Control group), 15 PCOS women received a low caloric diet (1200 Kcal/day) for 3 months,
      while group (B) (Study group), 15 PCOS women received visceral manipulation to the pelvic
      organs and the related structures (8 sessions, once per week in the first month then once
      every other week for two months) in addition to the same low-calorie diet as the group (A).
      Evaluations pre and post-study for body weight, body mass index, female reproductive hormones
      [luteinizinghormone (LH), follicle-stimulating hormone (FSH) and LH/FSH ratio] and
      menstruation-related problems were done by weight- height scale, blood analysis, and
      menstruation-specific domain of polycystic ovary syndrome health-related quality of life
      questionnaire (PCOSQ), respectively.
    

Intervention name(s): Low-calorie diet; Visceral manipulation with diet
Intervention type(s): Other; Other
Intervention description(s): Low-calorie diet of 1200 kcal for 3 months, modified every two weeks.; Visceral manipulation to the pelvic organs and their related structures (8 sessions, once per week in the first month then once every other week for two months) added to the same low-calorie diet as the group (A).
Other intervention name(s): Control group; Group (A); Study group; Group (B)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Polycystic ovarian women were assigned to either group (A), receiving a low-calorie diet for three months, or group (B), receiving the same diet as group (A) together with visceral manipulation of the pelvic organs and their related structures for the same study period (three months).
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Polycystic Ovary Syndrome; Menstruation Disturbances; Caloric Restriction; Manipulation Therapy
Efficacy and Safety of Lacidofil® STRONG as an Adjuvant for Helicobacter Pylori Treatment in Non-ulcer Dyspepsia
Condition: Helicobacter Pylori Infection
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Treatment for H. pylori eradication includes antibiotics. The treatment has decreased its
      efficiency (lower capability to eradicate the infection) due to increasing antibiotic
      resistance in the population. But the addition of probiotics to the treatment has been
      observed to increase efficiency, and decreasing the antibiotics' side effects. We set to
      evaluate whether Lacidofil® STRONG improves efficacy when added to the standard therapy to
      eradicate H. pylori.
    

Detailed description: 
      This study aims at evaluating the efficacy of Lacidofil® STRONG as an adjuvant therapy to a
      standard 14-day H. pylori eradication treatment among H. pylori-positive participants with
      non-ulcer dyspepsia.

      This is a randomized, placebo-controlled trial, with two parallel arms. Participants will be
      randomized to receive probiotic or placebo as adjuvant to the standard anti-H. pylori
      treatment. Each participant will be enrolled in the study for 12 weeks, during which they
      will receive the anti-H. pylori treatment and co-administration of investigational product
      (IP; for two weeks), followed by IP supplementation alone (for four weeks), and they will be
      followed-up 4 weeks after last IP administration.
    

Intervention name(s): Lacidofil; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Investigational product intake daily for 6 weeks. Co-administration of H. pylori treatment with investigational product the first two weeks only.; Investigational product intake daily for 6 weeks. Co-administration of H. pylori treatment with investigational product the first two weeks only.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, placebo-controlled, double-blind trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Injection of Cyanoacrylate+Lipiodol vs Cyanoacrylate+Lauromacrogol in Gastric Varices
Condition: Gastric Varices; Portal Hypertension
MeSH terms: Hypertension, Portal; Esophageal and Gastric Varices; Varicose Veins
Study type: Interventional

Summary: 
      The purpose of this randomized study to compare effect of endoscopic injection of a mixture
      of cyanoacrylate and lipiodol versus cyanoacrylate and lauromacrogol in gastric varices.
    

Detailed description: 
      Gastroesophageal variceal bleeding is known as one of the most frequent death causes of
      patients with portal hypertension. When a patient has a bleeding episode, if no further
      prophylactic treatments is given, it's very likely that he/she will develop another
      rebleeding event in the future and maybe a terminal event. Gastric varices occur in 18-70% of
      patients with portal hypertension, which appear to be more severe, to require more
      transfusion and to have a higher mortality rate than esophageal variceal bleeding, with a
      high rate of rebleeding(38-89%). It has been recommended to use endoscopic cyanoacrylate
      injection as the first line treatment for hemostasis and secondary prophylaxis for gastric
      varices by general consensus. However, the efficacy and prevalence of complications between
      mixture of cyanoacrylate + lipiodol and cyanoacrylate + lauromacrogol have not yet been
      explored and reported. We conducted this study to evaluate the effect of endoscopic injection
      of a mixture of cyanoacrylate and lipiodol versus cyanoacrylate and lauromacrogol in gastric
      varices.
    

Intervention name(s): Lipiodol; Lauromacrogol
Intervention type(s): Drug; Drug
Intervention description(s): endoscopic injection of lipiodol + cyanoacrylate + lipiodol for gastric varices; endoscopic injection of lauromacrogol + cyanoacrylate + lauromacrogol for gastric varices
Intervention MeSH terms: Ethiodized Oil; Polidocanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of PROVIGIL ® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Obstructive Sleep Apnea/Hypopnea Syndrome
Condition: Sleep Apnea, Obstructive
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleepiness
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objectives of the study are to determine the effectiveness of PROVIGIL treatment,
      compared to placebo treatment, in children and adolescents with excessive sleepiness (ES)
      associated with obstructive sleep apnea/hypopnea syndrome (OSAHS), as assessed by:

        -  mean sleep latency from the Multiple Sleep Latency Test (MSLT) (average of 4 naps
           performed at 0900, 1100, 1300, and 1500) at the last post baseline observation (week 6
           or early termination)

        -  the Clinical Global Impression of Change (CGI-C) ratings for ES, at the last post
           baseline observation (week 6 or early termination).
    

Detailed description: 
      PROVIGIL is a trademark of Genelco, SA, licensed to Cephalon, Inc.
    

Intervention name(s): Modafinil
Intervention type(s): Drug
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Pediatric Obstructive sleep Apnea; Excessive sleepiness; CPAP; Pediatric OSAHS
A Study of Patients Treated With the Journey Deuce Bicompartmental Knee System
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      This is a prospective, multicenter, consecutive clinical study of the Journey Deuce Knee
      System and is intended to evaluate the safety and effectiveness of the new device.
    

Detailed description: 
      The objectives of this study are to assess the safety and effectiveness of the Journey Deuce
      Bicompartmental Knee System. Patients will be examined clinically at time intervals
      throughout the study duration. Exams will include completion of clinical assessment, x-rays,
      and completion of patient questionnaires.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patients eligible for this study are non-inflammatory degenerative joint disease
        patients requiring a primary unilateral knee surgery. The affected areas must be limited to
        the medial and patellofemoral compartments.
      
Keywords: Deuce; Journey Deuce; Knee pain; Osteoarthritis; Bicompartmental; Femoral; Medial
Assessing the Benefits of the Vibraject Attachment
Condition: Pain
Study type: Interventional

Summary: 
      Behavioral and physiologic observations suggest that the injection of local anesthetic is
      among the most feared or anxiety producing procedures during dental intervention. Discomfort
      during the injection is currently reduced by pharmacologic or mechanical methods. No
      technique has proven to be effective for every patient. The VibraJect LLC (USA) was first
      introduced in 1995 and was developed under the hypothesis that a vibrating needle would
      stimulate large diameter nerve fibers and thereby close the gate to smaller nerves carrying
      the pain signal from the injection site. Studies on adult patients have been promising. The
      purpose of this study is to investigate the efficacy of the VibraJect dental syringe
      attachment in reducing injection discomfort and procedural anxiety in the pediatric dental
      population.
    

Detailed description: 
      One hundred children will be recruited from the UNMC Pediatric Dentistry clinic. Eligible
      children will be selected from the 4-6 year group who are scheduled for routine dental
      restorative treatment and who have or have never received a dental injection. Each patient
      will randomly participate in either a control or experimental condition. The device will be
      attached for both conditions. During the control injection, the dentist will perform the
      dental injection as usual. During the experimental injection, the dentist will activate the
      attached device and perform the injection. Immediately following each injection, the patient
      will rate the pain on a visual analog scale and a trained observer will rate the child's
      behavior on a Frankl behavior scale. A videotape of the procedure will be reviewed by an
      independent dentist who will evaluate the child's response and any perceived disruptive
      behavior. This observer will be blind to whether the instrument is functioning.
    

Intervention name(s): Vibraject
Intervention type(s): Device
Intervention description(s): The VibraJect clips onto the barrel of a conventional and intraligamentary dental syringe (and some disposable syringes) and vibrates the needle at a high frequency while injections are administered.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of HSK3486 Compared to Propofol for Adults Undergoing Elective Surgery With General Anesthesia
Condition: General Anesthesia
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate HSK3486 0.4/0.2 mg/kg (0.4 mg/kg intravenous [IV] slow injection over 30 [±5]
      seconds for the first dose, an additional 0.2 mg/kg if needed) is non-inferior to propofol
      2.0/1.0 mg/kg (2.0 mg/kg IV slow injection over 30 [±5] seconds for first dose, an additional
      1.0 mg/kg if needed) in success of induction of general anesthesia in adults undergoing
      elective surgery.
    

Detailed description: 
      This is a multicenter, randomized, double-blinded, propofol-controlled, phase 3 clinical
      study to evaluate the efficacy and safety of HSK3486 for induction of general anesthesia in
      adults undergoing elective surgery with endotracheal intubation.

      After screening, eligible subjects will be randomized in a 2:1 ratio to receive either
      HSK3486 0.4/0.2 mg/kg (i.e., 0.4 mg/kg IV slow injection over 30 [±5] seconds followed by an
      additional 0.2 mg/kg dose over 10 [±2] seconds if needed) or propofol 2.0/1.0 mg/kg (i.e.,
      2.0 mg/kg IV slow injection over 30 [±5] seconds followed by an additional 1.0 mg/kg dose
      over 10 [±2]seconds if needed) in a blinded manner. Enrolled subjects will be stratified by
      American Society of Anesthesiologists Physical Status (ASA-PS; I-II and III-IV), age (<65 and
      ≥65 years), and Body Mass Index (BMI <35 and ≥35 kg/m2). Endotracheal intubation will be
      performed after adequate anesthetic induction (Modified Observer's Assessment of
      Awareness/Sedation [MOAA/S] ≤1) (Appendix 1) has been achieved and administration of
      neuromuscular blocking agent.

      Before surgery, premedication is allowed except for sedative-hypnotic or analgesic drugs.
      Premedication should be recorded if used.

      Prior to administration of the study drug in the operating room, the preoperative readiness
      of each subject will be confirmed. Oxygen will be supplied through a facemask (oxygen flow
      rate: ≥4 L/min) at least 2 minutes before study drug administration. Subsequently, the
      investigator can adjust the oxygen flow according to the specific situation of the subject
      and maintenance IV solution (normal saline [NS], lactated ringer's [LR], or 5% dextrose) will
      be administrated through IV infusion. Throughout the preinduction and induction periods, a
      timing device must be used to allow accuracy and sequencing of necessary assessments.
    

Intervention name(s): HSK3486; Propofol
Intervention type(s): Drug; Drug
Intervention description(s): HSK3486 for induction of general anesthesia; Propofol for induction of general anesthesia.
Other intervention name(s): Diprivan
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Surgical pre-induction analgesia
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Transversus Abdominis Plane (TAP) Block After Laparoscopic Colon Surgery
Condition: Laparoscopic Colon Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the effectiveness of Transversus Abdominis Plane
      (TAP) block as a part of a multimodal postoperative pain management after laparoscopic
      surgery on colon.
    


Intervention name(s): Transversus abdominis plane (TAP) block; Placebo TAP block
Intervention type(s): Procedure; Procedure
Intervention description(s): Bilateral UL-guided TAP block with 20 ml of ropivacaine 0,5%; Bilateral placement of 20 ml of saline 0,9% in the transversus abdominis plane
Other intervention name(s): Naropin; Placebo block
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Capecitabine and Paclitaxel in Treating Patients With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase I/II trial to determine the effectiveness of combining capecitabine and
      paclitaxel in treating patients who have metastatic breast cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose (MTD) of capecitabine when combined with paclitaxel
           in patients with metastatic adenocarcinoma of the breast.

        -  Determine the clinical efficacy of the dose immediately preceding the MTD identified in
           phase I, in terms of response rate, time to treatment failure, time to disease
           progression, and overall survival, in these patients.

        -  Determine the toxicity of this regimen in these patients.

        -  Determine a well-tolerated drug combination for these patients.

      OUTLINE: This is a dose-escalation, multicenter study of capecitabine.

      Patients receive oral capecitabine twice daily on days 1-14 and paclitaxel IV over 1 hour on
      days 1, 8, and 15. Treatment repeats every 21 days for a maximum of 6 courses in the absence
      of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of capecitabine until the maximum tolerated
      dose (MTD) is determined. The MTD is defined as the dose at which 2 or more of 6 patients
      experience dose-limiting toxicity. Once the MTD is determined, additional patients are
      treated at the dose level immediately preceding the MTD.

      Patients are followed every 3 months.

      PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for phase I and 15-46 patients
      will be accrued for phase II of this study.
    

Intervention name(s): capecitabine; paclitaxel
Intervention type(s): Drug; Drug
Intervention MeSH terms: Paclitaxel; Capecitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV breast cancer; recurrent breast cancer