bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of The Surgical Drain Placement With Use of Kinesiologic Tape
Condition: Impacted Third Molar Tooth
MeSH terms: Tooth, Impacted
Study type: Interventional

Summary: 
      The investigator's purpose was to compare the effects of the surgical drain and kinesiologic
      tape applications on postoperative morbidity after mandibular third molar surgery.
    

Detailed description: 
      A total of 90 patients will be scheduled for impacted third molar surgery. The patients will
      be divided into 3 groups.All surgeries will be carried out by the same surgeon. Group A will
      be treated with kinesiologic tape, Group B will be treated with a surgical drainage tube and
      Group C will be control group. After surgery in control group, routine surgical extraction
      will be performed.The investigators will compare postoperative pain, swelling, trismus and
      patients' comfort.

      The duration of each procedure from the start of the incision to the time of last suture
      placement will be noted.

      Patients are recalled on days 2, 7, 14 postoperative pain, facial swelling, maximum mouth
      opening, wound dehiscence. For the assesment of the pain, visual analog scale will be used.
      For the swelling evaluation, measurement will be done from the different three region on the
      face:

        -  Tragus-Pogonion

        -  Tragus-Labial Commissura

        -  Angulus Mandible-Lateral canthus

      Maximum mouth opening will be noted before and after (one week later) the surgery.
    

Intervention name(s): Kinesiologic Tape Group; Drain Group; Control Group
Intervention type(s): Procedure; Procedure; Other
Intervention description(s): A mucoperiosteal flap will be raised, a conventional rotary handpiece will be used under irrigation for removing the third molar.Primary wound closure will be accomplished using 3-0 silk sutures.The kinesiologic tape will be prepared individually for each patient; it will be cut into three equal strips (approximately 1.6 cm in width) and placed between the clavicle and the tragus-commissura line. The patients will be invited after one week for removing the sutures.; A mucoperiosteal flap will be raised, a conventional rotary handpiece will be used under irrigation for removing the third molar.Primary wound closure will be accomplished using 3-0 silk sutures. A plastic non-customised drain tube (2-cm long, 2-mm diameter) will be inserted into a vertical incision between the first and second molars and sutured to the vestibular mucosa. The patients will be invited after one week for removing the sutures.; Routine third molar extraction will be performed. No extra procedures will be done after surgery.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Kinesiology tape; Surgical drain; Pain; Swelling; Trismus
A Long-Term Safety and Tolerability Study of ALKS 3831 in Adults With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the long term safety and tolerability of
      ALKS 3831 in subjects with schizophrenia.
    


Intervention name(s): ALKS 3831
Intervention type(s): Drug
Intervention description(s): Tablets were administered for daily dosing
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alkermes; ALKS 3831; Samidorphan; Schizophrenia; Safety
Rivaroxaban for Patients With Antiphospholipid Syndrome
Condition: Antiphospholipid Syndrome
MeSH terms: Antiphospholipid Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      Long-term anticoagulation is widely used for secondary thromboprophylaxis in the
      antiphospholipid syndrome (APS) due to the high risk of recurrent events. Currently
      anticoagulation with vitamin K antagonists (VKAs) is the standard of care but have
      unpredictable pharmacodynamic properties that requiere monitoring for dose adjustment.
      Rivaroxaban, an orally active direct factor Xa inhibitor, has been shown to be effective and
      safe compared with warfarin for the treatment of venous thromboembolism and non valvular
      atrial fibrillation in major RCTs. No studies had been published in APS.The aim of the study
      is to investigate the efficacy and safety of rivaroxaban in preventing recurrent thrombosis
      in patients with APS compared with acenocoumarol
    

Detailed description: 
      This is a phase 3 randomized, multicenter, non-inferiority open-label RCT. 190 eligible APS
      patients with arterial or venous thrombotic history receiving acenocoumarol will be
      stratified according the presence of SLE and venous/arterial thrombotic history and
      randomized (1:1) either to continue vitamin K antagonists (standard of care, normalized ratio
      (INR) 2-3 or 2.5 to 3.5 in those with recurrent thrombotic episodes) or to switch to
      rivaroxaban (20 mg/day). The primary efficacy outcome is the development of any thrombotic
      event during the study period. Secondary efficacy outcomes include time to thrombosis, type
      of thrombosis (arterial or venous), overall causes of death, evaluation of a prognostic
      biomarker panel of recurrent thrombosis. The primary safety outcome will be major bleeding.
      Secondary safety outcomes include any adverse event and minor bleeding.
    

Intervention name(s): Rivaroxaban; acenocumarol
Intervention type(s): Drug; Drug
Intervention description(s): Rivaroxaban will be started at 20 mg/day. Dose will be adjusted according to Cr Clearance. Cr Clearance 30-49 ml/min will receive 15 mg/day.; Doses will be adjusted according to INR
Other intervention name(s): XARELTO; SINTROM
Intervention MeSH terms: Rivaroxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Implementation of a Structured Lifestyle Program in Primary Care. Changes in Lifestyle Habits and Cardiovascular Risk.
Condition: Cardiovascular Risk Factor; Lifestyle Risk Reduction; Primary Care
Study type: Interventional

Summary: 
      The aim of the present study is to describe and evaluate the effect of a structured lifestyle
      intervention program, focusing on lifestyle habits, in a primary care setting in patients
      with high cardiovascular risk. Furthermore, we want to explore the patient´s experience of
      lifestyle change and counseling after participation in the intervention program and to
      investigate the cost-effectiveness of the program.
    

Detailed description: 
      Intervention The intervention program comprises five individual visits to the same nurse,
      specialised in diabetes care and the metabolic syndrome every three month during one year.
      The nurse led a person centered dialog based on the answers from a questionnaire. At every
      visit, focus was primarily on lifestyle habits, using motivational interviewing to strengthen
      the patient's ability to modify one or more lifestyle habits. Dietary counselling was in
      accordance with the Swedish recommendation in nutrition. If the patient were in need of
      extended counseling regarding one or more lifestyle habits, he or she could be referred
      within the primary care unit to a specialist. During the 12-month period, all patients where
      offered to participate in evening group sessions at three different occasions. Topics were
      physical activity, fatty acids, healthy food, tobacco and alcohol, stress, sleep and methods
      of how to change behavior".
    

Intervention name(s): structured lifestyle program
Intervention type(s): Behavioral
Intervention description(s): Intensive Lifestyle counseling during one year
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
A Study in Healthy Volunteers to Assess the Relative Bioavailability and Tolerability of Two Crenezumab Formulations Following Administration of a Single Subcutaneous Dose
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the relative bioavailability and tolerability of two different formulations of
      crenezumab in approximately 60 healthy volunteers.
    


Intervention name(s): Crenezumab; Crenezumab
Intervention type(s): Drug; Drug
Other intervention name(s): RO5490245 or MABT5102A (formerly); RO5490245 or MABT5102A (formerly)
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial to Investigate the Efficacy and Safety of Orally Administered Tolvaptan (OPC-41061) in Patients With Chronic Renal Failure Undergoing Hemodialysis or Hemodiafiltration
Condition: Chronic Renal Failure
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study to investigate the efficacy and safety of OPC-41061 by 24-week oral
      administration of OPC-41061 at 15-mg or 30-mg or placebo in patients with chronic renal
      failure who are undergoing hemodialysis or hemodiafiltration and who have daily urine volume
      of at least 500 mL/day.
    


Intervention name(s): OPC-41061; OPC-41061; Placebo
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Tolvaptan; Tolvaptan; Blank Tablet
Intervention MeSH terms: Tolvaptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Undergoing Hemodialysis; Undergoing Hemodiafiltration
Wake Therapy in the Treatment of Depression
Condition: Major Depressive Disorder; Bipolar Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder
Study type: Interventional

Summary: 
      This pilot study seeks to replicate previous findings that sleep deprivation results in
      marked improvement in depression symptoms, as well as to test whether concurrent treatment
      with Light Therapy and Lithium are successful in locking in and maintaining therapeutic
      effects in both bipolar and unipolar depressed subjects.
    

Detailed description: 
      Both refractory depression and bipolar depression are difficult to treat. A night of complete
      sleep deprivation has been shown to result in marked improvement in 60% of depressed
      patients, although maintenance of therapeutic effects have not been sustained with wake
      therapy alone. This pilot study will assess the effectiveness of wake therapy in treating
      both bipolar depression (5 participants)and major depression (5 participants), as well as the
      effectiveness of concomitant light therapy and lithium in maintaining the therapeutic
      effects. Participants will undergo direct observation in the hospital for one week during
      initial treatment with alternating nights of sleep deprivation, light therapy and lithium
      treatment, and then will be seen weekly as outpatients for 6 weeks.
    

Intervention name(s): Wake Therapy; light box; Lithium
Intervention type(s): Behavioral; Device; Drug
Intervention description(s): Maintaining wakefulness on alternating nights over 7 days, with continued sleep deprivation the next day.; use of a lightbox titrated between 15-60 minutes (typically 30 minutes), timed according to chronotype score on the Morningness-Eveningness Questionnaire; For patients not already taking lithium, dose will start at 600 mg daily (all in the evening) and be adjusted in 300 mg/d increments according to weekly blood levels (i.e., lithium dose may be changed once a week if most recent blood level is too low; if too high, it will be decreased or temporarily discontinued as clinically indicated; 150 mg increments will be utilized if multiples of 300 mg result in intolerance or blood levels outside the target range (0.6 - 1.0 mEq/L)
Other intervention name(s): Day Light; Lithobid, lithium carbonate
Intervention MeSH terms: Lithium Carbonate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Depression
Correlation Between Neck Pain and Postural Abnormalities Among Female Office Workers at University of Dammam
Condition: NECK PAIN
MeSH terms: Neck Pain
Study type: Observational

Summary: 
      This study is a cross sectional study conducted to find out the Correlation between neck pain
      and postural abnormalities among female office workers at University of Dammam by objective
      assessments methods.

      Eligible participants will sign the consent form followed by filling up demographic data,
      visual analog scale & neck disability index.

      After that, Forward Head posture and Thoracic Kyphosis posture will take place by valid and
      reliable methods.
    

Detailed description: 
      The study population and sampling were calculated by Raosoft sample size calculator using an
      estimated average of population size 200 and allowing a 5% tolerable error, based on a 95%
      confidence interval (CI).

      About 140 female office workers were targeted from the medical colleges of University of
      Dammam (UoD); Medicine, Applied Medical Science, Nursing, Dentistry, Clinical Pharmacology
      and Health Track of preparatory year were recruited into the study (N=140).

      The study was approved by the Institutional Review Board (IRB) at the University of Dammam
      (IRB-PGS-2015-03-194).

      Eligible individuals for this study were informed of the risks and benefits and were asked to
      read and sign a written consent form.

      Participants' confidentiality was maintained by using a code (number) instead of the
      participant's name on the data collection form.

      All data collection forms were saved in a file and secured in a locker & the electronic file
      saved with password. Only the researcher and the supervisor had an access to them.
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        participants been recruited from the medical collages at university of Dammam
      
Keywords: NECK PAIN, OFFICE WORKERS
Effects of Green Tea Extract on Obese Women With High Level of LDL
Condition: Obese; Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      Green tea is one of the most popular beverages in the world. It is believed to have
      beneficial effect in prevention and treatment of many diseases, one of which is reducing
      LDL-C. The aim of the study is to examine the effect of supplement containing GTE on obese
      with high LDL level.
    

Detailed description: 
      Randomized, double-blind, crossover placebo-controlled clinical trial
    

Intervention name(s): green tea extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 500 mg three times per day; cellulose 500mg three times a day for 6 weeks
Other intervention name(s): EGCG; cellulose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: obese women; high LDL-C
Acceptance of Complementary Medicine in Germany
Condition: General Population
Study type: Observational

Summary: 
      Complementary medicine is widely practiced in Germany and worldwide. The aim of this study is
      to explore how many people use complementary medicine methods in Germany, for which
      health-related issues they do and for which they would not.
    


Intervention name(s): Cross-sectional survey
Intervention type(s): Other
Intervention description(s): No intervention.
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Respondents are recruited from Respondi institute's pool of test persons, but remain
        completely anonymous with regard to their personal data and answers; they are also not
        subsequently or indirectly identifiable.
Voiding Disorders in Children After Sacrococcygeal Teratoma Resection
Condition: Sacrococcygeal Teratoma; Neurogenic Bladder; Voiding Disorders
MeSH terms: Teratoma; Urinary Bladder, Neurogenic
Study type: Observational

Summary: 
      Sacrococcygeal teratomas are the most common neonatal tumors and require rapid and complete
      resection. Tumor nerve compression and pelvic surgical sequelae may lead to many and varied
      voiding disorders. Data concerning long-term vesico-sphincteric disorders are conflicting.
      Some studies find good functional results [Cozzi et al., 2008; Draper et al., 2009]. However
      other authors reveal neurologic bladder with detrusor sphincter dyssynergia [Hambraeus et
      al., 2018] and rise concerned about long-term renal function [Khanna et al., 2019; Rehfuss et
      al., 2020] even in the absence of clinical voiding disorders. Most of studies include young
      patients with other malformations such as anorectal malformations or dysraphisms which may
      impact the results. The main objective is to assess bladder dysfunction in children aged 6 to
      18 years after isolated sacrococcygeal teratoma resection.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who underwent surgical treatment of a sacrococcygeal teratoma, without ano rectal
        malformation or any other neurological pathology
      
Keywords: Teratoma; sacrococcygeal region; urinary incontinence; neurogenic bladder; children
The Effects of Modafinil to Counteract the Adverse Metabolic Consequences of Sleep Restriction
Condition: Sleep Restriction; Impaired Glucose Metabolism
Study type: Interventional

Summary: 
      The purpose of the study is to examine the effects of sleep and modafinil on how the body
      processes glucose.
    

Detailed description: 
      The occurrence and diagnosis of DM2 and its complications is increasing, leading to rising
      treatment costs that represent a considerable portion of the U.S. health care budget.
      Although treatment of impaired glucose tolerance (IGT) is not common, an IGT diagnosis
      increases the likelihood of progression to DM2. Careful attention to glycemic control is a
      primary treatment goal for DM2 patients, as glucose control reduces the severity of
      microvascular, macrovascular, and other complications.

      Recent research has indicated that sleep loss could be a previously unrecognized risk factor
      for DM2. As sleep restriction has become an endemic condition in developed countries, it is
      possible that sleep loss contributes to the recent epidemic of DM2. Protecting sleep by
      increasing sleep duration and quality in DM2 and IGT patients may provide an inexpensive,
      relatively easy to implement intervention to reduce the risk of disease onset or delay
      disease progression by improving glucose tolerance. Furthermore, measurement of endocrine,
      metabolic, and cardiovascular parameters in the proposed studies may provide insights into
      the mechanisms by which sleep extension improves glucose tolerance under pathophysiological
      conditions.

      The proposed study examines and quantifies in adults the link between insufficient sleep and
      increased insulin resistance, impaired insulin secretion, and reduced non-insulin-dependent
      glucose utilization by the sleepy brain. The proposed study capitalizes upon the unique
      pharmacological characteristics of modafinil to reverse excessive sleepiness to address the
      mechanisms by which sleep restriction may impact metabolism via excessive sleepiness. This
      study may lead to countermeasures to the adverse health impact of chronic insufficient sleep,
      an increasingly common lifestyle that may ultimately contribute to the development of the
      Metabolic Syndrome or DM2 via alterations of glucose metabolism and brain glucose
      utilization.
    

Intervention name(s): modafinil; placebo
Intervention type(s): Drug; Drug
Intervention description(s): During each day of the 7-day sleep restriction phase of the study modafinil was administered (200 mg tablet at 0600, and a second dose of 100 mg tablet at 1300).; During each day of the 7-day sleep restriction phase of the study a sugar pill was administered.
Other intervention name(s): Provigil
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: sleep restriction; glucose metabolism; modafinil; euglycemic clamp; insulin sensitivity; insulin release
Prevention of Chemotherapy Induced Ovarian Failure With Goserelin in BC Patients (ZORO)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Study done in young breast cancer patients to prevent chemotherapy induced ovarian failure
    

Detailed description: 
      Study Design:

      Prospective, randomized, open phase II trial

      Schedule:

      All patients will receive an anthracycline-containing polychemotherapy.

      Patients randomized to Goserelin will receive their first injection of 3.6 mg at least 2
      weeks before start of chemotherapy. Goserelin will be given as a subcutaneous injection in
      the abdominal wall every 4 weeks (28 ± 3 days) until the end of the last chemotherapy cycle.

      Primary objective:

      •To increase the percentage of patients with normal ovarian function at 6 months after
      application of (neo)adjuvant, anthracycline-containing polychemotherapy in parallel with
      Goserelin compared to chemotherapy alone.

      Secondary objectives:

      To compare the two treatment groups regarding

        -  Compliance to treatment

        -  Toxicity

        -  Quality of life

        -  Menopausal Symptoms Score

        -  Ovarian function at 6, 12, 18 and 24 months

        -  Duration until recovery of regular menstrual period

        -  Pregnancy rate
    

Intervention name(s): Goserelin
Intervention type(s): Drug
Intervention MeSH terms: Goserelin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hormone insensitive breast cancer; Prevention of Chemotherapy induced ovarian failure; P.O.F.; GnRH-Agonist Goserelin