cyrilzakka/clinical-trials huggingface dataset:
Anticoagulation in Critically Ill Patients With COVID-19 (The IMPACT Trial)

The purpose of this study is to determine if therapeutic dose anticoagulation (experimental group) improves 30-day mortality in participants with COVID-19 compared to those patients receiving the intermediate dose prophylaxis (control group). Following screening, subjects will be randomized 1:1 to intermediate dose prophylaxis or therapeutic dose anticoagulation treatment arms.Treatment will continue for 28 days, followed by a 6 month follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old
* COVID-19 positive on (RT-PCR) nasopharyngeal swab, or suspected COVID-19 infection with detectable SARS-CoV-2 IgG or IgM.
* Intensive care unit (ICU) patient or non-ICU patient on invasive mechanical ventilation, BiPAP, 100% non-rebreather mask, or high flow oxygen or supplemental oxygen of at least 4 liters per minute nasal cannula.
* D dimer level greater than 700 ng/mL (3 times the upper limit of normal).

Exclusion Criteria:

* Objectively documented deep vein thrombosis or pulmonary embolism
* Patients in whom there is very high suspicion for pulmonary embolism and are on full-dose anticoagulation as per the treating physician
* Platelets \<30,000 not due to disseminated intravascular coagulation (DIC), based on the International Society of Thrombosis and Haemostasis (ISTH) criteria and American Society of Hematology (ASH) Frequently Asked Questions
* Active bleeding that poses a contraindication to therapeutic anticoagulation in the opinion of the investigator.
* History of bleeding diathesis (e.g., hemophilia, severe von Willebrand disease, severe thrombocytopathy)
* History of intracranial hemorrhage in the last 90 days
* History of ischemic stroke in the past 2 weeks
* Major neurosurgical procedure in the past 30 days
* Cardiothoracic surgery in the past 30 days
* Intra-abdominal surgery in the past 30 days
* Intracranial malignancy
* Patients who require therapeutic anticoagulation for other reasons like atrial fibrillation, deep venous thrombosis, pulmonary embolism, or antiphospholipid syndrome.
Sensorimotor Dysfunction in Achalasia

This study is being done to assess the esophageal muscle (swallowing tube) in patients with and without achalasia to further understand and help direct the treatment for patients with achalasia.

Achalasia is currently defined solely on the basis of esophageal manometry. However, this fails to assess sensory function which may relate more to symptoms such as chest pain and heartburn. To date, the importance of sensory dysfunction in achalasia is poorly understood. The investigators want to define the relationship between esophageal sensory and motor dysfunction and symptoms in achalasia.

Following standard diagnostic evaluation including esophagogastroduodenoscopy (EGD), barium esophagram, and esophageal manometry, symptoms will be assessed utilizing a standardized questionnaire. The subjects will then undergo transoral placement of an esophageal barostat. Following a standard protocol of esophageal distension, esophageal body compliance will be recorded with esophageal body pressure and volume. Mechanosensitivity will then be assessed utilizing a stepwise esophageal distension, with patients reporting symptoms utilizing a Likert scale. Patients will then undergo conventional achalasia treatment with either pneumatic dilation or Heller myotomy at the discretion of the treating gastroenterologist. Thereafter patients will be followed via a standardized phone survey at 3 months, 6 months, 2 years, and 4 years after treatment to assess symptoms and treatment response. Patients will have standard clinical follow ups, including barium esophagram, at 1 year, 3 years, and 5 years following treatment. Outcomes: From 100 new patients with achalasia seen yearly at Mayo, the investigators anticipate recruitment of 40 eligible patients over 12 months and 10 healthy volunteers. The correlation between mechanosensitivity and esophageal body compliance with symptoms such as dysphagia, chest pain, and heartburn will be measured in Types I, II and III achalasia. The association of these parameters with conventional manometrically defined achalasia subtypes will also be measured. Finally, the relationship between sensorimotor dysfunction in achalasia and therapeutic outcomes will be assessed with development of predictive models to assess symptomatic outcome by barostat measurements.

Eligibility Criteria:
Inclusion Criteria:

* Adults ages 18-90
* Patients with achalasia, defined by an esophageal manometry study consistent with the diagnosis

Exclusion Criteria:

* Patients with EGD or esophagram findings suggestive of pseudoachalasia
* Previous history of pneumatic dilation, Heller myotomy, or botulinum toxin injection to the distal esophagus
* Esophageal diameter greater than 6 cm
* Previous history of upper gastrointestinal surgery
* Medical conditions such as severe heart or lung disease that preclude safe performance barostat
* Inability to read due to: Blindness, cognitive dysfunction, or English language illiteracy
Tui-na and Oral Chinese Medicine on KOA

The study aims to evaluate the therapeutic effect of the Tui-na and oral Chinese medicine on the treatment of KOA.

This is a prospective, randomized wait-list controlled trial in patients with knee osteoarthritis (KOA). After 2 weeks screening period, eligible subjects will be randomly assigned to the treatment group and wait-list control group in 1:1 ratio. Subjects will have 4-week of treatment, and then a 4-week follow-up.

The subjects will come for a screening visit at week 0 (baseline), then at week 2, week 4, and week 8 for Chinese medicine practitioner (CMP) investigators assessments. The Western Ontario and McMaster University Osteoarthritis index (WOMAC) and EQ-5D-5L will be assessed and filled up at different timepoints. The treatment group will receive both Tui-na and study medication and the wait-list control group will receive Tui-na alone. CMPs will provide consultation under Chinese medicine theory. Study medication compliance and adverse events will also be assessed at each visit.

Eligibility Criteria:
Inclusion Criteria:

1. of either gender (female must have either sterilization done or menopause)
2. ≥50years of age
3. meet the criteria of KOA according to the American College of Rheumatology

   * Knee pain, and
   * Any 4 of the following,

     * ≥ 50 years of age
     * Less than 30 minutes of morning stiffness
     * Crepitus on active motion
     * Bony tenderness
     * Bony enlargement
     * No palpable warmth of synovium
     * Osteophytes (Radiographic findings)
4. with WOMAC score ≥ 39
5. with written informed consentform signed (for illiterate subjects, their next-of-kin or an impartial witness will sign with subjects' permission)

Exclusion Criteria:

1. Known knee pain caused by infection, malignant or autoimmune diseases
2. Knee surgery or arthroscopy in the past year
3. Chondroprotective or intra-articular injection in the past 4 months
4. Systemic corticoid treatment in the past 4 months
5. Taking anticoagulants, antiplatelets, corticosteroids, psychiatric drugs, hormones, antiarrhythmic drugs or diuretics drugs
6. Subject with uncontrolled hypertension
7. Local antiphlogistic treatment, acupuncture, physiotherapy in the past 2 weeks
8. Known history of mental disorder
9. Known history of serious acute organic disease
10. Renal or liver function impairment
11. Known allergy to or have drug interaction with the study herb
A 4-Arm Efficacy and Safety Study of RT001 for the Treatment of Moderate to Severe Lateral Canthal Lines in Adults

The purpose of this study is to find out if an investigational drug, called RT001 Topical Gel, is safe and useful in minimizing the wrinkles between the eye and hairline called lateral canthal lines, also known as crow's feet wrinkles.

RT001, a new drug, may be effective for the temporary improvement in the appearance of moderate to severe lateral canthal lines (crow's feet wrinkles) in adults. In this study, researchers want to find out if RT001 is more effective than three comparator groups by examining the effect on the improvement of crow's feet by both the patient and physician.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent including authorization to release health information
* Female or male, 18 to 65 years of age and in good general health
* Willing and able to follow study instructions and likely to complete all study requirements
* Moderate to severe lateral canthal lines (crow's feet wrinkles)

Exclusion Criteria:

* Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A, including peripheral motor neuropathic diseases such as amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional disorders such as Lambert-Eaton syndrome and myasthenia gravis
* Muscle weakness or paralysis, particularly in the area receiving study treatment
* Active disease or irritation at the treatment areas including the eye and the skin
* Pregnant, nursing, or planning a pregnancy during the study; or is a women of child bearing potential (WOCBP) but is not willing to use an effective method of birth control
* Previous participation in a RT001 clinical study
A Clinical Study of KLH-2109 in Uterine Fibroids Patient With Menorrhagia and Pain

Multi-center, randomized, double-blind, parallel-group study to confirm superiority of KLH-2109 to placebo in uterine fibroids patient with menorrhagia and pain


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal Japanese woman diagnosed with uterine fibroids
* Patients confirmed by transvaginal ultrasonography to have at least 1 myoma that meet all of the following conditions:
* Larger than a certain standard
* No calcification
* Not receiving surgical treatment
* Patients with a normal menstrual cycle
* Patients diagnosed with menorrhagia
* Patients with pain symptoms associated with uterine fibroids

Exclusion Criteria:

* Patients with complication or history of blood system diseases (salasemia, sickle erythrocyte anemia, folic acid deficiency, coagulation disorder, etc.) (excluding iron deficiency anemia and latent iron deficiency anemia)
* Patients with lower abdominal pain due to irritable bowel syndrome or lower abdominal pain due to severe interstitial cystitis
* Patients with undiagnosed abnormal genital bleeding
Bilateral and Unilateral Amblyopia Treatment Study

The purpose for this study is to investigate spectacle compliance and treatment outcome in bilateral and unilateral refractive amblyopia in children age 3 to \<10 years old. Specifically, how frequently and for what duration is spectacle wear necessary to maximize best-corrected visual acuity by spectacle correction alone.

The purpose for this study is to investigate spectacle compliance and treatment outcome in bilateral and unilateral refractive amblyopia in children age 3 to \<10 years old. Specifically, how frequently and for what duration is spectacle wear necessary to maximize best-corrected visual acuity by spectacle correction alone.

Eligibility Criteria:
Inclusion Criteria:

* Age 3 to \< 10 years
* Subjects and their parent/guardian speak and understand English adequately to complete the study protocol and give informed consent. Subjects have the ability to adhere to the study visit schedule.
* All refractive error measures below will be determined by cycloplegic retinoscopy by one of the study investigators during the comprehensive eye exam. Measures are in minus cylinder spectacle prescription format.

Inclusion criteria for bilateral amblyopia:

The major eligibility criteria include:

* Best-corrected visual acuity of \<20/30 each eye.
* For hypermetropia:

  * Spherical equivalent \>+2.00 D each eye.
  * Spherical equivalent difference between eyes \<1.25 D.
* For astigmatism without hypermetropia criteria above or myopia criteria below:

  * \>1.75 D each eye
  * Difference between eyes \<1.25 D
* For myopia:

  * Spherical equivalent \<-5.00.
  * Spherical equivalent difference between eyes \<1.25 D.

Inclusion criteria for unilateral amblyopia:

The major eligibility criteria include:

* Presence of anisometropia or constant unilateral strabismus.
* Best-corrected visual acuity in the amblyopic eye \<20/30; and interocular difference of best-corrected visual acuity at least two logMAR lines.
* For anisometropia:

  * Spherical equivalent ≥ 1.00 D interocular difference
  * Astigmatism \>1.75 D interocular difference
* For constant unilateral strabismus where spectacle prescription is indicated. Examples where spectacle prescription is indicated include esotropia caused at least in part by an accommodative component or where significant refractive error in either eye warrants spectacle prescription for improved vision.

Exclusion Criteria:

* History of spectacle wear
* Previous treatment for amblyopia
* Active amblyopia treatment planned other than spectacles at enrollment
* Prior intraocular or refractive surgery
* Ocular or systemic abnormalities that the examining investigator deems could impact prognosis for visual improvement. Examples could include birth history that may have affected brain development, extremely low birth weight (\<1.5 lbs), seizure disorders, cerebral palsy, optic nerve hypoplasia, cranial nerve palsy. Examples that would usually not exclude are off axis media opacity, low birth weight (2.0-3.5 lbs) without complication, mild limitation of extraocular muscle. Cognitive impairment that prohibits accurate data collection
Lifestyle Intervention for Cardiovascular Disease Risk Factors Among Female Residents at the National Guard Residential City, Jeddah, Saudi Arabia

Cardiovascular disease (CVD) remains the major cause of mortality globally. Applying a comprehensive interventional program based on the individual's risk may reduce the incidence and complications of CVD; thus, helping to decrease the burden on the healthcare system. This study compared the effects of a 3-month intervention involving lifestyle modification and physical activity with standard care in women ≥30 years having a moderate-to-high risk of CVD, with respect to improving physical activity and cardiovascular disease risk factors at the National Guard Residential City in Jeddah, Saudi Arabia, in 2015. The effects of this community-based lifestyle program were assessed through a randomized controlled trial. Women in the intervention group (n=31) received health education, exercise training, and diet counselling as individuals and in groups according to the participant's risk. Women in the control group (n=28) received one health education session at the screening site. The Framingham risk score (FRS) was calculated at baseline and at 3 months for both groups. The mean participant age was 42±8 years.


Eligibility Criteria:
Inclusion Criteria:

1. Women aged ≥ 30 years.
2. The participants must be at moderate to high-risk of CVD according to FRS.

Exclusion Criteria:

1. Women aged \< 30 years.
2. Women aged ≥ 30 years with low risk of CVD according to FRS.
3. Pregnant women.
4. Female patients diagnosed with CVD.
Sleep and Cognition After Ambulatory Hip and Knee Arthroplasty

Sleep and rest are key elements in postoperative rehabilitation and recovery. There are complex relations between major surgery, sleep disturbance and complications. Major surgery leeds to severe postoperative sleep disturbances, initially reducing REM sleep time and disturbing the remaining sleep stages. Major surgery is again a risk factor for postoperative delirium and other cognitive impairment. The underlying mechanisms includes pain, opioid medication, sleep disturbances and neuroinflammation, along with external factors as noise during hospitalisation. The physiologic stress from sleep disturbances and sleep deprivation is associated with blood-brain barrier impairment, inflammation, decreased restitution, altered nociceptive function. Likewise, undiagnosed and untreated sleep apnea is a risk for postoperative complications and is itself affected by anesthesia and some analgesics (i.a. opioids).

Fast-track surgery development has led to restitution period shortening, optimized pain management reducing opioid use, postoperative inflammatory stress response reduction and less delirium. Evolution of hip and knee arthroplasty(THA/TKA), organisation, optimized pain management and pharmacologic modification of inflammatory response by high dose steroid has permitted to perform these surgeries in an outpatient setting.

Previous studies of fast-track THA/TKA using multimodal opioid-sparring analgesia, however neither using high dose steroids nor in an out patient setting, have demonstrated REM sleep period reduction from a normal range of 18% preoperatively to 1% postoperatively. However, changes in sleep architecture after THA/TKA in at setting attempting to minimise abnormal sleep by means of ambulatory surgery added to perioperative reduction of inflammatory response to surgery, pain and opioid use by high dose steroid, haven't been studied.

The purpose of this study is to investigate how much an optimized ambulatory THA/TKA , reducing pain and inflammatory response to surgery and opioid use by high doses steroid can conserve the preoperative sleep architecture.


Eligibility Criteria:
Inclusion Criteria:

* ASA classification I or II
* Scheduled hospital discharge same day after surgery
* Adult person following the patient 24 hours at the patients habitation
* Informed consent and signature.
* Patient speaks and understands Danish

Exclusion Criteria:

* Hospital discharge later than same day after surgery
* No consent form patient
* Alcohol or drug abuse
* Anxiolytic og antipsychotic treatment
* Preoperative opioid treatment
* Soporific treatment
Immunological Follow-up After Allogeneic Hematopoietic Stem Cell Transplantation

Description of the evolution of the biological characteristics of immune blood populations and biomarkers of interest in patients who have received allogeneic hematopoietic stem cell transplantation.

a more in-depth analysis of the different immune cell sub-populations as well as serum markers (cytokines) would provide a better understanding of post-allograft immune reconstitution mechanisms and identify potential immunologic biomarkers predictive of GVH or relapse.

Eligibility Criteria:
Inclusion Criteria:

1. Allogeneic hematopoietic stem cell transplant for hematological malignancy
2. Patients 18 years of age or older
3. Signed consent to participation
4. Membership in a social security scheme, or beneficiary of such a scheme.

Exclusion Criteria:

* A person of legal age subject to a legal protection measure (major under guardianship, curatorship or court bail), or unable to express consent (language criteria included).
Endoscopic Resection of Papillary Adenomas; a Novel Treatment Algorithm to Prevent Recurrence - a Pilot-study (ERASE-pilot)

Recurrence after endoscopic papillectomy is described in up to 33% of the cases (range 12-33%). This leads to re-interventions, a cumulative risk of adverse events, and the need for long-term follow-up. Recurrences most likely originate from either the biliary orifice or lateral resection margins. Ablative methods such as radiofrequency ablation (RFA) and thermal ablation by cystotome inside the bile duct have been described to treat intraductal extension of which the use of a cystotome seems to have a more favorable safety profile. However, no studies focusing on the preventive use of these ablative methods in patient with papillary adenomas have been performed. It is hypothesized that the curative resection rate can be increased and recurrence prevented by using a combination of snare tip soft coagulation (STSC) of the resection margins and thermal ablation by cystotome of the biliary orifice in patients with and without the suggestion of intraductal extension.

Therefore, aim of this study is to assess the safety and feasibility of endoscopic papillectomy combined with thermal ablation of the biliary orifice by cystotome and STSC of the lateral resection margins.


Eligibility Criteria:
Inclusion Criteria:

* Papillary adenoma which seems suitable for curative endoscopic resection.
* 18 years or older.
* Capable of providing written and oral informed consent.

Exclusion Criteria:

* Patients with intraductal extension of \>1 cm beyond the duodenal wall or adenocarcinoma will be excluded since surgical resection is considered the preferred treatment in these cases.
* Failure to place a PD stent in patients with normal pancreatic duct anatomy.
* Refusal to provide informed consent.
Postoperative Pain Management After Total Knee Arthroplasty

The study compares three different analgesic techniques in order to determine which one serves as the optimal method for postoperative pain management after Total Knee Arthroplasty in patients suffering from Osteoarthritis

Prospective, randomized, controlled study. Approval of the study from the University Hospital of Patras Ethics Committee. The Total Knee Arthroplasty procedure is performed always from the same team of Orthopedic surgeons who follow the same technique in each patient for the arthroplasty and the placement of the intraarticular catheter as well. The same team of Anesthesiologists (two Anesthesiologists) performs always the same technique for each analgesic method and is responsible for the patients' perioperative condition concerning anesthesia and analgesia.

Preoperatively, one hour prior to the surgery, all patients receive preemptive multimodal analgesia in the following way; 40mg Parecoxib (iv), 1gr Paracetamol (iv), 150mg Pregabalin (po), 8mg Dexamethasone (iv) και 50mg Ranitidine (iv).

All patients receive subarachnoid anesthesia with Ropivacaine 0.75% (7,5mg/ml) in a dosage of 2-3ml titrated according to patient's age and height.

Three groups

1. Continuous epidural infusion (control group) with Ropivacaine 0.2% + clonidine 150μg.
2. Continuous femoral nerve blockade infusion with Ropivacaine 0.2% + clonidine 150μg.
3. Continuous intraarticular infusion with Ropivacaine 0.2% + clonidine 150μg.

All the catheters remain for 48 hours while the infusion rate is 2ml/h + PCA with 0,5ml/15min and lock-out maximum dose 4/h in total volume of 150ml.

Postoperatively all patients also receive; Parecoxib, Paracetamol, Pregabalin, and Ranitidine up to the third postoperative day (doses titrated).

Rescue analgesia: Tramadol Chloride 50-100mg x 2 /24h depending on patient's age and medical history.

Eligibility Criteria:
Inclusion Criteria:

1. Patients scheduled for unilateral total knee arthroplasty (TKA) to treat knee osteoarthritis (OA)
2. Fully conversant in the Greek language
3. Written informed consent to participate in the trial

Exclusion Criteria:

1. Age less than 50 years and greater than 85 years.
2. ASA score \>III
3. Pregnancy
4. Subarachnoid anesthesia failure
5. Hypersensitivity/ allergy to certain agent used
6. Participation in other research/ study
7. Severe mental disease (schizophrenia, major depression, severe bipolar disorder, substance abuse)
Incidental Finding of Gastrointestinal Stromal Tumors (GISTs) During Laparoscopic Sleeve Gastrectomy, How to Deal? How Much Safety Margin

LSG is thought to be the best choice for obese patients with conincidental GISTs, as a tumour can be resected along with resecting the stomach within the same procedure. The primary endpoint is that, how much does GIST suppose to be far from a staple line to do safe laparoscopic sleeve gastrectomy

The incidence of unsuspected GIST in LSG specimens in our series was high in comparison to cases reported in the literature.

GISTs could be safely removed laparoscopically during LSG surgery with negative microscopic resection margins, with 1-2cm safety margin. Margins less than 1cm, high mitotic rate are adverse prognostic factors.

Examining the whole stomach before resection is mandatory and can easily be done during LSG, GIST can be removed safely with LSG

Eligibility Criteria:
Inclusion Criteria:

All morbid obese patients with BMI more than 35

Exclusion Criteria:

* previous gastric surgery
* patients with hiatus hernia
* age under 21 years