bioihbjkbjnl/mcl2 huggingface dataset:
Prevalence of Gynecological Pathologies and Use of Hormonal Treatments in Women Hospitalized for a Venous Thromboembolic Episode
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Study type: Observational

Summary: 
      The incidence of venous thrombosis (venous thromboembolic disease: VTE) in women of
      childbearing age in France is in the order of 0.3 to 0.5 / 1000 women / year. It is a rare
      disease, but the majority of events occurring in women of childbearing age are associated
      with a particular hormonal context (mainly pregnancy and hormonal contraception). VTE is a
      multifactorial disease and the risk depends on the simultaneous presence of several triggers.
    

Detailed description: 
      Certain frequent gynecological pathologies are emerging in the literature as new venous
      thrombotic risk factors independently of hormonal treatment. Indeed, in endometriosis, the
      prevalence of which is estimated to be around 10%, biological data are in favor of
      hypercoagulability. Only one epidemiological study has analyzed this parameter. It is a
      Japanese cohort study in 103,070 pregnant women including 77 VTE during pregnancy.
      Endometriosis and recurrent pregnancy loss (RPL) were identified as risk factors for VTE (OR:
      2.70 (95%CI, 1.21-6.00) for endometriosis and 6.13 (95% 2.48-15.16) for RPL. In polycystic
      ovary syndrome (PCOS), whose prevalence is estimated at 7-12%, the associated risk of VTE is
      better known (OR 1.89, 95%CI 1.60-2.24) and was the subject of a recently published
      meta-analysis in which the principal investigator collaborated. To the investigators
      knowledge, no study describes the prevalence of gynecological pathologies in women with VTE.

      Concerning hormonal contraception, estrogen-progestin contraception (EPC) is widely used in
      France and is associated with an increase in the risk of VTE of a factor of 3 to 6. After a
      venous thrombotic episode, EPC is contraindicated, and non-hormonal or progestin-only
      contraception (POC) can be used. Nevertheless, to date, few studies have focused on the
      management of hormonal contraceptive treatment at the time of a VTE episode. Moreover, the
      contraceptive options presented to patients are often based on multiple actors (vascular
      physicians, gynaecologists, midwives, general practitioners, etc.) and the experience of the
      VTE episode, for both patients and prescribers, may influence the contraceptive options
      proposed or chosen, as well as their compliance.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women aged 18 to 50 years hospitalized at Saint Joseph Hospital between 01/01/2016 and
        12/31/2020 for VTE
Study to Determine D-amino Acid Oxidase Brain Enzyme Occupancy of TAK-831 After Single-dose Oral Administration
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the relationship between TAK-831 dose, plasma
      exposure, extent and duration of brain D-amino acid oxidase (DAO) enzyme occupancy following
      single oral dosing of TAK-831 in healthy participants.
    

Detailed description: 
      The drug being tested in this study is called TAK-831. TAK-831 is a highly selective and
      potent inhibitor of DAO, a peroxisomal enzyme active towards neutral D-amino acids which
      potentially effects cerebellar dysfunction. This study will look at the relationship between
      TAK-831 plasma exposure and the extent and duration of brain DAO enzyme occupancy after
      single oral dosing of TAK-831 in healthy male participants using [18F]PGM299 radioactive
      tracer injection and PET imaging.

      The study will enroll up to 22 participants in two different sets. Up to 16 participants will
      be enrolled in Set A. Within that total, up to 5 dose levels of TAK-831 may be evaluated,
      with up to 6 participants per dose level, although typically, there will be 2 to 3
      participants per dose level. All participants in Set A will also receive up to 3 doses of
      [18F]PGM299. Up to 6 participants will be enrolled in Set B. All participants in Set B will
      be assigned to single treatment group to receive 2 doses of [18F]PGM299.

      All participants in Set A will be asked to take single oral dose of TAK-831 suspension on Day
      1. In Set A, each of the participant will receive a maximum of 3 PET scans with [18F]PGM299;
      1 at baseline 2 following a single oral dose of TAK-831 on Days 1 and 2. In Set B, each of
      the participant will receive 2 PET scans with [18F]PGM299 on Days 1 and 10. Set B will be
      conducted after the confirmation of blockade of [18F]PGM299 binding by TAK-831 in 2 to 4
      participants of Set A.

      This multi-center trial will be conducted in the United Kingdom. The overall time to
      participate in this study is 62 days. Participants in Set A will make 4 visits to the clinic,
      and participants in Set B will make 3 visits to the clinic and all will be contacted by
      telephone on Day 15 (Set A) and Day 12 (Set B) of treatment period for a follow-up
      assessment.
    

Intervention name(s): TAK-831; [18F]PGM299
Intervention type(s): Drug; Drug
Intervention description(s): TAK-831 oral suspension.; [18F]PGM299 injection
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Drug therapy
The Effect of Mindfulness Programs on Postoperative Pain
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Participants undergoing hand surgery will be assessed and compared for postoperative pain.
      The patients' experience of going through surgery will be evaluated. The patient satisfaction
      and patient assessed outcomes will be measured.
    

Detailed description: 
      Participants undergoing hand surgery will be randomized into either a control group or one of
      two groups that undergo mindfulness training during the perioperative period. One of the
      treatment groups will be enrolled in the program "Prepare for Surgery, Heal Faster" provided
      by NYU. The other treatment group will be enrolled in Wim Hof Method, a meditation program.
      This program is not provided by NYU, but instructions will be provided to the patient on how
      to complete the meditative exercises involved in this established method. Postop pain
      medication and pain scores will be monitored.
    

Intervention name(s): "Prepare for Surgery, Heal Faster" Program; Wim Hof Method
Intervention type(s): Behavioral; Behavioral
Intervention description(s): This NYU program teaches patients how to feel calmer before surgery. Patients are taught relaxation techniques by phone or in person by trained NYU personnel. The program uses five steps to ease stress-related symptoms prior to surgery and improve help recovery time. By practicing deep relaxation, it is possible to reduce anxiety and promote a feeling of calmness. The patient swill be enrolled in the course preoperatively and will be ask to continue these meditations for ten weeks.; Patients will be enrolled in Wim Hof Method, a breathing/meditation program. This is a free online program, developed by a man named Wim Hof and his techniques. On this website, he explains the origins and methods behind his teachings ( https://www.wimhofmethod.com/iceman-wim-hof. ). Patients in this group will take the online free course provided by the Wim Hof Method. The patients will be introduced to the online course preoperatively. The three pillars of the WHM are 1) breathing/meditation, 2) stretching exercises and 3) gradual cold exposure. The patients will be told to concentrate on the breathing and meditation component, they may not be able to participate in the cold exposure (cold showers, ice baths) in the immediate post op period because of the open wounds.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
The Efficacy and Safety of AChE Inhibitor Donepezil As Adjunctive Treatment to Mood Stabilizers in Acute Mania
Condition: Bipolar Disorder; Mania
MeSH terms: Mania; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      There is a high rate of partial response to standard thymoleptic medication. In this study
      the investigators want to evaluate the safety and efficacy of donepezil as adjunctive
      treatment to mood stabilizers in bipolar disorder with acute mania. The investigators
      hypotheses were that there would be greater mean reduction in manic symptoms with donepezil
      augmentation of lithium compared with placebo.
    

Detailed description: 
      Bipolar disorder is a chronic mental illness that affects 1-2% of the general population.
      Lithium and valproate are effective for treatment of acute mania for many patients. However
      up to half of patients do not respond adequately to currently approved treatments in the
      acute phase of mania. More effective treatment for mania are need. Imbalance in cholinergic
      and adrenergic tone has long been postulated in the pathophysiology of bipolar disorder. In
      the pathophysiology of mania,relative cholinergic hypoactivity was being implicated.
      Donepezil is a centrally acting reversible acetylcholinesterase inhibitor. It is approved for
      the treatment of Alzheimer's disease. In an open case series with standardized ratings,
      addition of donepezil 5-10 mg/day to ongoing mood-stabilizer treatment was associated with
      marked improvement in treatment-resistant mania. We want to conduct a 4-week randomized,
      double-blind, placebo-controlled trial of donepezil as augmentation of lithium in patients
      with acute manic episode to evaluate the safety and efficacy of donepezil as adjunctive
      treatment to mood stabilizers in bipolar disorder with acute mania.
    

Intervention name(s): Donepezil and Lithium; Placebo plus Lithium
Intervention type(s): Drug; Drug
Intervention description(s): Donepezil dose will be started at 5mg/d and increased to 10 mg/d in 1 week.
Other intervention name(s): Aricept
Intervention MeSH terms: Lithium Carbonate; Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acetylcholinesterase inhibitor; donepezil; bipolar disorder; mania; lithium
Effects of Autogenic and Reciprocal Inhibition Techniques With Conventional Therapy in Mechanical Neck Pain
Condition: Mechanical Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The objective of this randomized control trial is to determine the effectiveness of Autogenic
      and Reciprocal Inhibition techniques with conventional therapy in mechanical neck pain to
      improve Pain, Range of Motion, and Functional Disability in long term. This study is being
      conducted at the Physiotherapy department of Sindh Institute of Physical Medicine and
      Rehabilitation, Karachi (former institute of Dow University of Health Sciences) among 80
      patients with mechanical neck pain on the basis of non-probability purposive sample technique
      with screening for study criteria through a consultant physician (blinded) . After taking
      informed consent all participants will be randomly allocated in two groups through second
      researcher who is not involved in screening, baseline assessment and providing intervention.
      Group 1 will receive Autogenic Inhibition muscle energy technique (MET) with conventional
      therapy and Group 2 will receive Reciprocal inhibition MET with conventional therapy. A total
      of 12 sessions will be provided. Outcomes will be assessed at baseline, after 1st session,
      and at last session.
    


Intervention name(s): Autogenic Inhibition MET; Reciprocal Inhibition MET
Intervention type(s): Other; Other
Intervention description(s): If a sub-maximal contraction of the muscle is followed by stretching of the same muscle it is known as Autogenic Inhibition MET.; If a submaximal contraction of a muscle is followed by stretching of the opposite muscle then this is known as Reciprocal Inhibition MET.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: It is a randomized control trial. Total 80 patients will be recruited, 40 in each group that includes 10 patients as a dropout in both groups. There will be one interventional group and one active comparator group. Treatment will be allocated using a random number sheet generated by statistician. Participants are assigned to one of two groups in parallel for the duration of the study.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Neck Pain; Manual Therapies; Therapy-Soft Tissue; Muscle Stretching exercises
Training Study to Evaluate the Benefit of Exercise for Patients With Chronic Heart Failure
Condition: Dilated Cardiomyopathy; Chronic Heart Failure
MeSH terms: Heart Failure; Cardiomyopathies; Cardiomyopathy, Dilated
Study type: Interventional

Summary: 
      The study investigates the safety and effectiveness of a 12 week endurance training program
      for patients with chronic heart failure
    


Intervention name(s): Endurance training
Intervention type(s): Behavioral
Intervention description(s): 45 min ergometer cycling at the ventilatory anaerobic threshold 4 times per week for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise; heart failure; dilated cardiomyopathy; Endurance training
A Home-Based Walking Program and rTMS in Helping Breast Cancer Survivors Get More Physical Activity
Condition: Cancer Survivor; Invasive Breast Carcinoma
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This trial studies how well a home-based walking program, with or without repetitive
      transcranial magnetic stimulation, works in helping breast cancer survivors get more physical
      activity. Physical activity has been shown to improve health outcomes and quality of life
      among breast cancer survivors and can help lessen certain side effects of treatment such as
      fatigue, depression, and treatment-related weight gain. Repetitive transcranial magnetic
      stimulation is a procedure that uses electromagnets to stimulate brain activity. Using rTMS
      with a home-based walking program may help breast cancer survivors get more physical
      activity.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To examine the effects of 20 hertz (Hz) repetitive transcranial magnetic stimulation
      (rTMS) on delay discounting rates and multiple measures of self-regulation and walking.

      OUTLINE: Patients are randomized to 1 of 2 groups.

      GROUP I: Patients participate in a home-based exercise program of at least 10,000 steps per
      day (about 30 minutes of daily exercise) for 5 days weekly (150 minutes per week) for 12
      weeks. Patients also undergo repetitive transcranial magnetic stimulation over 1 hour for 8
      sessions during the first 2 weeks of the walking program.

      GROUP II: Patients participate in a home-based exercise program of at least 10,000 steps per
      day (about 30 minutes of daily exercise) for 5 days weekly (150 minutes per week) for 12
      weeks. Patients also undergo sham repetitive transcranial magnetic stimulation over 1 hour
      for 8 sessions during the first 2 weeks of the walking program.
    

Intervention name(s): Physical Activity; Questionnaire Administration; Repetitive Transcranial Magnetic Stimulation; Sham Intervention
Intervention type(s): Other; Other; Procedure; Procedure
Intervention description(s): Participate in home-based walking program; Ancillary studies; Undergo rTMS; Undergo sham rTMS
Other intervention name(s): rTMS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies.
Condition: Cirrhosis
MeSH terms: Fibrosis
Study type: Interventional

Summary: 
      The project will improve scientific knowledge regarding a recent law applying potentially to
      every french driver. It will give for the first time an indication on the impact of alerting
      treatments on driving risks. It will reinforce the links between different research
      environments (sleep physiopathology, clinical research, cognitive neurosciences, drivers
      supervision, virtual reality, pharmacology) among the "Réseau Eveil Sommeil Attention et
      Transports" (RESAT) network.
    

Detailed description: 
      Excessive daytime sleepiness is responsible of 20% of traffic accidents and 2/3 of truck
      accidents on French Freeways. Since the publication of a new law (2005 december 28th -
      Official Journal) regulating fitness to drive, the Maintenance of Wakefulness Test (MWT) is
      now mandatory to evaluate driving skills of patients suffering of excessive daytime
      sleepiness. The MWT has shown a good predictability of driving handicap on simulators in
      patients suffering from obstructive sleep apnea syndrome. Nevertheless no study has proven
      yet the predictability of the MWT regarding real and simulated driving in patients suffering
      from hepatic encephalopathy. Furthermore, even if therapeutic drugs significantly improve MWT
      scores there is no data available concerning the impact of these drugs on fitness to drive.
      Lactulose, a treatment of hepatic encephalopathy, has not been tested as a counter measure to
      driving impairment. This lack of knowledge is a major handicap to evaluate driving skills of
      treated patients suffering from excessive daytime sleepiness. The main objective of our
      project is to test the predictive value of the MWT on real and simulated driving performances
      in untreated and treated sleepy patients suffering from hepatic encephalopathy.
    

Intervention name(s): L-carnitine; Lactulose
Intervention type(s): Drug; Drug
Intervention description(s): L-carnitine 4g per day (4 bottles of 10ml).; Lactulose (30-60 ml per day)
Other intervention name(s): Levocarnil.; Duphalac.
Intervention MeSH terms: Lactulose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: sleep; cirrhosis; encephalopathy; simulated driving; sleep disorders
Lornoxicam Versus Etodolac After Third Molar Surgery
Condition: Pain, Acute; Edema; Trismus
MeSH terms: Trismus; Acute Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Our study aimed to compare the effect of lornoxicam and etodolac on postoperative pain, edema
      and trismus following lower third molar extraction
    

Detailed description: 
      20 patients included in study (4 male, 16 female). Lornoxicam and etodolac was given
      following lower third molar extraction. Pain was evaluated 2., 6., 12., 24., and 48. hours
      using VAS. Edema was evaluated by measuring tragus-labial commissure, angulus- lateral
      canthus of eye and angulus mandible-labial commissure. Trismus was evaluated measuring mouth
      opening by caliper. Edema and Trismus was evaluated by 48. and 168. hours
    

Intervention name(s): Lornoxicam 8 Mg Oral Tablet
Intervention type(s): Drug
Intervention description(s): Lornoxicam is a oxicam grup non-steroid antiinflamatuar drug
Other intervention name(s): Etodolac
Intervention MeSH terms: Etodolac; Lornoxicam
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Vitamin D Supplementation on in Major Orthopedic Surgery
Condition: Hypovitaminosis D; Cardiovascular Diseases
MeSH terms: Rickets; Cardiovascular Diseases; Avitaminosis; Vitamin D Deficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      Prospective, monocentric study in open, aimed at evaluating the effects of supplementation
      with calcifediol on left ventricular function parameters in cardiopathic subjects undergoing
      major orthopedic surgery.
    

Detailed description: 
      Population of the study: 47 cardiopathic patients with hypovitaminosis D supplemented with
      calcifediol to reach vitamin D levels> 30 ng / ml within 6 months. The purpose of this study
      is to evaluate the improvement of the ejection fraction or GLS (global longitudinal strain)
      calculated by speckle tracking at 6 months in cardiopathic patients with vitamin D deficiency
      during functional recovery after major orthopedic surgery.
    

Intervention name(s): Didrogyl
Intervention type(s): Drug
Intervention description(s): Calcifediol will be administered at a dose of 10 drops per day (as indicated for use) for 6 months or until vitamin D levels> 30 ng / ml are obtained.
Once these values have been obtained, the dosage can be reduced to a dosage of 4/5 drops of calcifediol (1 drop contains 5mcg of calcifediol) with the aim to maintain the plasma values of 25 (OH) D in a optimal range between 30-60 ng / ml during the 6 month of the duration of the study.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Online Education and Counseling Regarding Gynecological Examination
Condition: Gynecological Disease
MeSH terms: Genital Diseases, Female
Study type: Interventional

Summary: 
      This research was carried out to determine the effect of online education and counseling on
      women's attitudes and anxiety levels regarding gynecological examination.

      The research is a pre-test-post-test, randomized controlled experimental study.
    

Detailed description: 
      The research is a pre-test-post-test, randomized controlled experimental study. Simple
      randomization method was used to assign the participants to the groups. The sample consisted
      of a total of 100 women (experimental group: 50 women and control group: 50 women). The study
      was carried out with women who applied to Aydın Adnan Menderes University Application and
      Research Hospital, Gynecology Clinic, Gynecology Outpatient Clinic and met the study
      criteria.
    

Intervention name(s): Online education and counseling
Intervention type(s): Behavioral
Intervention description(s): Online education and counseling regarding gynecological examination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: gynecological examination; attitude; anxiety; online; education; counseling