cyrilzakka/clinical-trials huggingface dataset:
The Influence of Prone Position for Spinal Surgery on Visual Acuity

This study investigated the effect of desflurane and propofol anesthesia on visual acuity in patients in prone position for spinal surgery. Many trials have investigated the effects of different anesthetic agents on intraocular pressure, propofol may reduce intraocular pressure more than other intravenous anesthetics.

Perioperative increase in intraocular pressure can be caused by prone positioning. In addition to surgical factors, patients with glaucoma, uncontrolled hypertension, arthrosclerosis, and morbid obesity are at risk for potentially damaging optic nerve and loss of optic nerve function. Some studies found that intraocular pressure values were significantly lower in patients undergoing propofol total intravenous anesthesia than in patients undergoing desflurane anesthesia during intraoperative positional changes. Pronounced vasodilatation caused by desflurane might produced hyperaemia with higher intraocular pressure. Hemodynamic response to prone position measured by near-infrared spectroscopy (NIRS) on the prefrontal cortex could determine changes caused by prone position.

Eligibility Criteria:
Inclusion Criteria:

* Glasgow Coma scale 15
* American Society of Anesthesiologists (ASA) Physical Status Classification System I-III
* spinal surgery in duration less than 3 hours
* sinus rhythm

Exclusion Criteria:

* postoperative artificial ventilation
* serious neurological disease
* lung disease with hypercapnia
* propofol allergy
Rocket Study: A Study to Characterize Biomarkers and Disease Progression in Participants With Pelizaeus-Merzbacher Disease

The purpose of the study is to prospectively assess longitudinal changes in proteolipid protein 1 (PLP1) protein, disease-related biomarkers in cerebral spinal fluid (CSF) and blood, neuroimaging parameters relevant to Pelizaeus-Merzbacher disease (PMD) and longitudinal changes in performance on clinical, participant, and caregiver-reported outcome assessments to inform the development of therapies for PMD.

This is a multi-center, non-randomized, non-interventional integrated prospective and retrospective study in up to 32 participants with PMD who can undergo general anesthesia or conscious sedation (if necessary) to collect fluid biomarkers (CSF and blood), neuroimaging, and clinical assessments to be used in support of the development of therapies for PMD. The study duration for each participant will be approximately 26 months (Week 106).

Eligibility Criteria:
Inclusion Criteria:

1. Participant has a parent or caregiver capable of providing informed consent (signed and dated) and able to attend all scheduled study visits and provide feedback regarding the participant's symptoms and performance as described in the protocol and be able to comply with all study requirements
2. Participant has a diagnosis of Pelizaeus-Merzbacher Disease with genetic confirmation of PLP1 duplication
3. Male, 6 months-17 years old, inclusive, at the time of informed consent and phenotype consistent with classic PMD
4. No contraindications for lumbar punctures (LPs), blood draws, neuroimaging, sedation (if necessary) or other study procedures

Exclusion Criteria:

1. Clinically significant abnormalities in medical history or physical examination
2. \> 2 copies of the PLP1 gene
3. Have any other conditions, which, in the opinion of the investigator would make the participant unsuitable for inclusion, or could interfere with the participant taking part in or completing the study
DOC Utility: Screening of Depression, Obstructive Sleep Apnea and Cognitive Impairment

The primary objective of this study is to determine whether baseline DOC screening can add to clinical and demographic data to predict the occurrence of a composite negative outcome (any of: recurrent stroke, myocardial infarction, death, or admission to a long-term care (LTC) / complex continuing care (CCC) facility) within one year of screening, in stroke prevention clinic patients.

The DOC screen will be routinely applied to all patients presenting to three high volume Regional Stroke Prevention Clinics (combined first visits \>2,800 patients per year). Data will be abstracted from the patient chart using methodologies developed and validated in the Registry of the Ontario Stroke Network. The investigators have REB approval to collect this data and to link with administrative datasets through the Institute for Clinical and Evaluative Sciences (ICES). The investigators will use regression models to determine whether DOC screen scores add to baseline clinical and demographic data to predict the main negative outcomes. The investigators hope to identify which patients presenting to TIA/stroke prevention clinics are at highest risk of adverse long-term events so focused interventions can be developed to improve survival, outcomes and function of stroke prevention clinic patients.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients referred to regional stroke prevention clinics.
* This includes those discharged from hospital with a diagnosis of stroke or TIA, as well as emergency department referrals.
* The DOC CRF will also be completed for patients who are unable to complete the screen due to severe aphasia, severe motor dysfunction and language barriers (those who are not fluent in English without translation available).

Exclusion Criteria:

* Patients whose reason for referral to the clinic is neither Stroke nor TIA, as well as those who have been admitted to LTC/CCC facilities at the time of clinic visit.
Molecular Basis of Altered Drug Metabolism During Pregnancy

The objectives of this application are to provide mechanistic understanding of altered drug metabolism by hepatic cytochrome CYP3A4 and to translate the findings to human pregnancy. A drug metabolized by CYP3A4, Quetiapine, will be the drug of choice mechanism to understand the enzyme's induction. Pregnant women currently on Quetiapine will be recruited. If the women enroll, the women will participate in four pharmacokinetic (PK) studies (one per trimester, and one postpartum).

The purpose of this research is to understand changes in a woman's body during pregnancy, specifically how the body processes medication during pregnancy.

The investigators know that over 90% of women take at least one drug during pregnancy. Because of the changes in a pregnant women's body, processes such as the rate of drug metabolism can change over the course of the three trimesters.

Drug metabolism is sometimes controlled by certain genes in the body. This study will be examining the up-regulation, or "speeding up" of a certain gene called CYP3A4, a gene that helps the body process Quetiapine.

The primary goal of this research is to understand how drug metabolism changes across pregnancy. The secondary goal for this research is to define how enzymes in the liver act to up-regulate CYP3A4 during pregnancy. This research will help to build a knowledge base for the prediction of drug metabolism changes and the design of optimal individualized dosage regimens for pregnant women.

The results of this study are expected to have a positive impact, as they will lay a foundation for the design of individualized drug therapy during pregnancy. This foundation will minimize the risk of over- and under-dosing pregnant women.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-45 years
* Pregnant, prior to 16 weeks gestation
* No chronic diseases or chronically administered medication
* Singleton or multiple gestation
* Subject may take aspirin, folate/multivitamins and other approved concomitant medications
* Taking Quetiapine for any clinical indication during pregnancy and postpartum
* Has made decision for Quetiapine treatment with prescriber prior to study entry

Exclusion Criteria:

* Chronic use of prescription or over the counter durgs during pregnancy with the exceptions listed under inclusions
* Substance dependence in the last 6 months
* Suicidal ideation with intent or suicide attempt in the last 6 months
INBONE™ Total Ankle Prosthesis With Long Talar Stem

The primary objective of this study is to collect preoperative, operative and postoperative clinical assessments of patients that qualify for surgical implantation of the INBONE™ Total Ankle Prosthesis.

The FDA approved the "limited enrollment" registry to provide us with additional clinical data from which to design a pivotal IDE study. FDA has stated that their decision for this was based upon "adequate safety information" which was submitted to them as part of the original IDE submission. Therefore, the purpose of this "limited enrollment" registry study is to gather initial data on the device's performance, when used with a Calcaneal Stem.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has sufficient soft tissue and muscle strength to support stable, anatomic positioning and motion of arthroplasty components as determined by the investigator
2. Subject must have sufficient skin for wound coverage.
3. Subject demonstrates subtalar joint insufficiency as defined by any of the following:

(1)range of motion \<50 percent of the contralateral, non-diseased side (2)pain during physical examination of the subtalar joint (3)fusion

AND

Subject demonstrates tibio-talar joint insufficiency as defined by any of the following:

1. end stage arthritis as determined by the investigator on plain radiographs
2. pain during physical examination of the tibio-talar joint
3. fusion
4. non-union
5. failed Total Ankle Replacement 4.Subject has Body Mass Index (BMI) \< 40 5.Subject has sufficient calcaneal bone stock as determined by the investigator 6.Subject is able to or capable of providing consent to participate in the clinical investigation and has medical insurance to cover costs associated with their medical care or is willing to assume personal responsibility for costs 7.Subject agrees to comply with this protocol, including participating in required follow-up visits at the investigations site and completing study questionnaires

Exclusion Criteria:

1. Subject is skeletally immature and under 21 years of age
2. Subject has experienced local or systemic infection within the past twelve months
3. Subject has symptomatic ankle disease or has been treated operatively on the contralateral side
4. Subject has vascular and kidney insufficiencies
5. Subject is suspected to have neuropathy of the foot or ankle
6. Subject has impaired vascular circulation in the affected limb
7. Subject has skin condition that may impair wound healing
8. Subject has known allergy to cobalt, chromium, molybdenum, titanium, aluminum, vanadium, or nickel
9. Subjects on long term medications which may compromise bone stock (e.g. long term steroids, NSAIDS, etc., physicians discretion
10. Subject is unwilling or unable to comply with a rehabilitation program
11. Subject is known to be pregnant, a prisoner, mentally incompetent, and/or alcohol or drug abuser
12. Subject is currently participating in any investigational study not related to this study's preoperative and postoperative care.
13. Subject has rheumatoid arthritis (RA)
14. Subject has been diagnosed with osteoporosis as defined as a DXA t-score \>-2.5.
Isoniazid Prophylaxis Based on Risk Factors of Tuberculosis in Living Kidney Transplantation Recipients

Tuberculosis (TB) is a major and severe opportunistic infection among solid organ transplant recipients. Chemoprophylaxis is advised for those with latent tuberculosis infection (LTBI). However, the effectiveness of an isoniazid (INH) prophylactic approach based on TB risk factors, without relying on tuberculin skin test (TST) or interferon-gamma release assay (IGRA), remains uncertain. Therefore, the investigators conducted this retrospective study to evaluate the safety and efficacy of a 6-month INH prophylaxis regimen guided by TB risk factors in kidney transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

1. living-donor kidney transplant recipients
2. receiving standard triad immunosuppressive regimen

Exclusion Criteria:

1. active TB infection
2. multiorgan transplantation
3. liver cirrhosis
4. malignancy history in the donor and recipient
5. human immunodeficiency virus infection
6. those who had received a nine-month course of INH.
Study About Contrast Media

Patients hospitalized with adhesive small bowel obstruction (SBO) are randomized to 2 study groups at admission after signing an informed consent form. Water-soluble contrast media (CM) will be administered after 4 or after 24 hours of nasogastric- tube decompression.

Patients presenting with symptoms of small bowel obstruction (SBO) will be evaluated and if the diagnosis of adhesive small bowel obstruction is made it must be decided what is the treatment of choice.

If immediate surgery is needed- it will not be delayed If patients are eligible for conservative management- they will be randomized to 2 study groups- contrast media (CM) after 4 hours of nasogastric-tube decompression and after 24 hours of nasogastric-tube decompression.

Contrast media challenge acquires radiographs (X-rays) to be taken after an interval (common practice) decided by the surgeon.

If at any point patient needs surgery- it will not be delayed. The results are compared. The hypothesis is, that if CM is administered sooner- it will help SBO resolution

Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years or older
* Adhesive small bowel obstruction diagnosed (clinical, laboratory and radiologic evaluation
* No peritonitis present, no need for an emergent surgery
* Patients sign an informed consent

Exclusion Criteria:

* Patients younger than 18 yeas
* Patients with mechanical small bowel obstruction caused by incarcerated hernias
* Patients with mechanical small bowel obstruction caused by carcinomatosis
* Patients with paralytic small bowel obstruction
* Patients who have undergone surgery within 6 weeks
* Patients who do not want to be enrolled in the study
Evaluating Effectiveness of Educational Intervention to Help Physicians Address Inappropriate Patient Requests for Direct-to-Consumer Advertised Prescription Medications

The purpose of this study is to determine whether physicians can be educated to better handle inappropriate requests from patients for direct-to-consumer advertised prescription medications.

Since changes in FDA regulation direct-to-consumer advertising (DTCA), pharmaceutical companies have expended increasing resources to market their products to the public. This has led to increased awareness of diseases and potential treatments, but it has also created more public demand for medications that may not be appropriate for a patient's clinical presentation. This study aims to provide physicians with the knowledge and skills required to help them address inappropriate DTCA medication requests from patients.

Eligibility Criteria:
Inclusion Criteria:

* Resident physicians in internal medicine or family medicine specialties at participating study sites

Exclusion Criteria:

* Completed less than 10 months of residency
Follow-up in Rivaroxaban Patients in Setting of Thromboembolism

In patients with acute clots (deep vein thrombosis or pulmonary embolism) the investigators will collect real world data on their short and long term outcomes. The investigators hypothesise that in patients treated from the outset with rivaroxaban that: 1. treatment will be non-inferior to treatment with conventional anticoagulants (heparins and warfarin); 2. there will be less bleeding than when patients are on conventional anticoagulants; 3. there will be a lower long-term incidence of morbidity from chronic thromboembolic pulmonary hypertension and post-thrombotic limb syndrome.

United Kingdom-only prospective, non-interventional, investigator-led, multi-centre, single cohort, registry. The observation period for each patient covers the treatment period with rivaroxaban and follow up until study end. For each patient, the treating health care professional records patient demographics, medical history, signs and symptoms, diagnosis, treatment and safety parameters at an initial visit and subsequent follow-up visit(s). Data monitoring will be undertaken by the Sponsor.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years or older with an objectively verified diagnosis of DVT and/or PE and treated according to routine clinical practice with Rivaroxaban

Exclusion Criteria:

* Patients in whom follow-up is unlikely or impossible
* Patients unable to give consent
* Patients who receive heparin therapy for more than 48 hours
* Patients who receive more than one dose of warfarin
* Patients with an indication for anticoagulation other than DVT and/or PE
* All contraindications listed in the local product information (SmPC) will form part of the exclusion criteria
Multicenter AIDS Cohort Study (MACS)

This is a comprehensive observational study of HIV infection in homosexual and bisexual men.

The Multicenter AIDS Cohort Study (MACS) provides important information about the changing nature of HIV-mediated disease progression, the impact of antiretroviral treatment, the nature of HIV pathogenesis, and viral and host genetic factors. This study will also assess the long-term patterns of therapy use and risk-taking behaviors.

Patients will have study visits every 6 months. The visits will include interviews, specimen collection, and a physical examination.

Eligibility Criteria:
Inclusion Criteria:

* HIV negative, or
* HIV positive and no history or current use of highly active antiretroviral therapy (HAART), or
* HIV positive HAART recipient with documentation of HAART initiation, no AIDS diagnosis prior to HAART initiation, and a CD4 cell count and HIV-1 RNA measurement within 6 months prior to first HAART use.
* Sexual intercourse with men or at least 5 male or female partners in the 5 years prior to enrollment.

Exclusion Criteria:

* Injection drug use within 1 year of enrollment.
* Perinatally acquired HIV infection.
Finnish Vitamin D Trial (FIND)

The Finnish Vitamin D Trial (FIND) is a randomized, double-blind, placebo-controlled, 5-year supplementation study of the benefits and risks of vitamin D in the primary prevention of cardiovascular (CVD) and cancer among 18000 men 60 years or older and women 65 years or older.

\[Edit 25.3.2015: Due to difficulties in recruitment and funding, the study size is approximately 2500 subjects, with a 550 subject subgroup with more detailed examinations\]

The participants will be randomized to 3 groups with 6000 in each, with daily supplementation of either: 1) 40 µg/day (1600 IU) of vitamin D3, 2) 80 µg/day (3200 IU) of vitamin D3, or 3) placebo.

\[Edit 15.3.2015: The 2500 subjects are randomized in 3 groups, approximately 830 subjects per group.\]

Compliance, use of non-study drugs or supplements, diet, development of endpoints, and CVD and cancer risk factors will be assessed by questionnaires. Blood samples will be collected for assessment of effect modification by baseline 25-hydroxyvitamin D, as well as for future ancillary studies of genetic/biochemical hypotheses. Event data will be obtained by record linkage from the national computerized hospitalization registry.

More detailed description available upon request.

Eligibility Criteria:
Inclusion Criteria:

* Men 60 years or older
* Women 65 years or older

Exclusion Criteria:

* Cardiovascular disease (including myocardial infarction, stroke, transient ischemic attack, angina pectoris, coronary artery bypass grafting, or percutaneous coronary intervention).
* Cancer (except non-melanoma skin cancer).
* Any disease or state that raises a vitamin D related safety concern (such as chronic liver, thyroid or kidney disease, hypercalcemia, sarcoidosis or other granulomatous diseases such as active chronic tuberculosis or Wegener's granulomatosis).
* Use of supplements yielding vitamin D over 20 µg/day or calcium over 1200 mg/day and unwillingness to discontinue the use.
Effect Of Resistive Exercises Versus Aerobic Exercises On Varicose Veins In Postmenopausal Women

The purpose of this study will be to determine the effect of resistive exercises on varicose veins in postmenopausal women, the effect of aerobic exercise on varicose veins in postmenopausal women and to compare between the effect of resistive exercise versus aerobic exercise on varicose veins in post menopausal women.

Varicose veins in the lower extremities present a spectrum of symptoms from cosmetic issues to severe discomfort including telangiectases, reticular veins, edema, pigmentation, and venous ulceration. These veins lead to painful swelling, skin discoloration, and potential complications like thrombosis, and nerve injury, impacting an individual's efficiency and life quality. Exercise, particularly aerobic and resistance training, has shown promise in improving pain severity, functional ability, and venous blood flow.

So, the current study will be conducted to compare between the effect of resistive exercises versus aerobic exercises on varicose veins in postmenopausal women.

Eligibility Criteria:
Inclusion criteria:

* All women suffering from varicose veins.
* Their age will range from 50 to 65 years.
* Their body mass index will range from 25 to 29.9 kg/m2.
* Voluntary acceptance of participation in the study.

Exclusion Criteria:

* Had history of serious vascular disease as deep venous thrombosis.
* Sensory deficient
* Any dermatological condition that interferes with the procedure.
* Any musculoskeletal or neurological disorders.
* Acute or healed ulcer wounds.
* Any heart disease or pulmonary disease.
Prospective Registration Study of Robtic Laparoscopy Versus Laparoscopy Assisted Colon Cancer Surgery

The purpose of this study is to compare the clinical data of patients with colon cancer who received robotic or laparoscopic surgery, and to compare the short-term and long-term effects of robotic surgery in the treatment of colon cancer. To verify the safety and effectiveness of the corresponding surgical methods, and provide better guidance for the following clinical practice.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-80 years old, male or female;
2. Colon cancer (ascending colon, transverse colon, descending colon, sigmoid colon) is diagnosed by histology or cytology;
3. The clinical stage is T1-4aN0-2M0; 4 No multiple distant metastases;

5. ECOG score 0-2; 6. Heart, lung, liver, and kidney functions can tolerate surgery; 7. Patients and their families can understand and are willing to participate in this clinical study, and sign an informed consent.

Exclusion Criteria:

1. Past history of malignant colorectal tumors or recent diagnosis combined with other malignant tumors;
2. Patients with intestinal obstruction, intestinal perforation, intestinal bleeding, etc. who need emergency surgery;
3. Neighboring organs need to be combined with organ resection;
4. New adjuvant therapy before surgery;
5. ASA grade ≥ grade IV and/or ECOG physical status score\> 2 points;
6. Those who have severe liver and kidney function, cardiopulmonary function, blood coagulation dysfunction, or combined with serious underlying diseases that cannot tolerate surgery;
7. Have a history of severe mental illness;
8. Pregnant or lactating women;
9. Patients with other clinical and laboratory conditions considered by the investigator should not participate in the trial.