cyrilzakka/clinical-trials huggingface dataset:
Examining the Benefit of Graduated Compression Stockings in the Prevention of vEnous Thromboembolism in Low-risk Surgical Patients

Hospital acquired thrombosis describes blood clots that form in the legs and lungs after someone is treated in hospital. Clots in the leg can cause swelling, pain and other problems. If a clot in the leg travels to the lungs, it may be life threatening. Having surgery increases the risk of developing blood clots.

People having short-stay surgery (who either go home the same day or who stay overnight but go home shortly afterwards) are at a much lower risk of developing a blood clot than those who stay in hospital for longer. These low-risk people are often given elastic stockings (which squeeze the leg muscles) to reduce the chance of a blood clot.

The risks of wearing the stockings are low but they can be uncomfortable. In the UK, there are over a million short stay surgeries performed each year and most of these people are given elastic stockings to wear. Stockings cost the NHS a lot of money and it remains unknown if they work.

This study will investigate if it is worthwhile to continue using elastic stockings in people having surgery where the risk of developing blood clots is low. Adults (over 18-years) who are at low risk of developing blood clots (assessed using a nationally recognised tool) will be included.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18-59 years of age) scheduled to undergo a surgical procedure with a hospital stay \<48 hours
* Individuals assessed as being at low-risk of developing VTE as per the DHRA Tool (i.e. no assessed thrombosis risk factors / scoring 0)

Exclusion Criteria:

* Individuals with a contraindication to GCS
* Individuals assessed as being at moderate or high-risk of VTE as per the DHRA tool
* Individuals requiring therapeutic anticoagulation
* Individuals with thrombophilia/ thrombogenic disorder
* Individuals with a previous history of VTE
* Individuals requiring intermittent pneumatic compression therapy beyond theatre and recovery
* Individuals requiring extended thromboprophylaxis beyond discharge
* Female patients of childbearing age who have a positive pregnancy test
* Individuals with lower limb immobilisation
* Inability to provide informed consent
Aprepitant, Granisetron, & Dexamethasone in Preventing Nausea & Vomiting in Pts. Receiving Cyclophosphamide Before a Stem Cell Transplant

RATIONALE: Antiemetic drugs, such as aprepitant, granisetron, and dexamethasone, may help lessen or prevent nausea and vomiting in patients treated with chemotherapy.

PURPOSE: This clinical trial is studying how well giving aprepitant together with granisetron and dexamethasone works in preventing nausea and vomiting in patients receiving cyclophosphamide before undergoing an autologous stem cell transplant.

OBJECTIVES:

Primary

* Evaluate the efficacy of the addition of aprepitant in controlling acute vomiting with the standard prophylactic anti-emetic combination of granisetron hydrochloride and dexamethasone in patients receiving therapy comprising high-dose cyclophosphamide to mobilize stem cells prior to leukapheresis for autologous stem cell transplantation.

Secondary

* Evaluate the efficacy of the addition of aprepitant in controlling delayed vomiting in these patients.
* Evaluate the efficacy of the addition of aprepitant in controlling overall nausea in these patients.
* Identify side effects of the addition of aprepitant to this regimen in these patients.

OUTLINE: Patients receive granisetron hydrochloride orally or IV and oral dexamethasone, followed 1 hour later by cyclophosphamide IV over 2 hours on day 1. Patients also receive oral aprepitant once daily on days 1-3. Treatment continues in absence of unacceptable toxicity.

After completion of study treatment, patients are followed for 30 days.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Undergoing autologous peripheral blood stem cell transplantation and stem cell mobilization using cyclophosphamide
* Candidate (per institutional requirements) for autologous peripheral blood stem cell transplantation

  * No psychiatric illness or multi-system organ failure
* No nausea at baseline

PATIENT CHARACTERISTICS:

* SWOG performance status 0-2
* Fewer than 5 alcoholic drinks per day within the past year
* No current illness requiring chronic systemic steroids or requirement for chronic use of anti-emetics
* No gastrointestinal obstruction or active peptic ulcer disease
* AST and ALT ≤ 3 times upper limit of normal (ULN)
* Bilirubin ≤ 3 times ULN
* Alkaline phosphatase ≤ 3 times ULN
* Creatinine ≤ 2 mg/dL
* No known hypersensitivity to any component of the study regimen
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective barrier contraception
* No unrelenting hiccups

PRIOR CONCURRENT THERAPY:

* No chronic therapeutic warfarin \> 1 mg dose per day
* No other concurrent investigational agents
* No concurrent oral contraceptives (except for stopping menses), tolbutamide, phenytoin, midazolam, ketoconazole, rifampin, paroxetine hydrochloride, or diltiazem hydrochloride
* No concurrent illegal drugs
Evaluate the Efficacy and Safety of Genexol®-PM Compared to Genexol® in Recurrent or Metastatic Breast Cancer

Phase III trial to evaluate the efficacy and safety of Genexol®-PM compared to Genexol® in subjects with recurrent or metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

Subjects should meet all of the following criteria to participate in the trial.

1. Subjects who aged 18 years or older.
2. Subjects whose written informed consent was obtained complying with the local regulatory requirements prior to their participation in the trial.
3. Subjects who have histologically or cytologically confirmed breast cancer with evidence of recurrence or metastasis.
4. If subjects have received Taxanes as neo-adjuvant or adjuvant therapy, the subjects should have relapsed with breast cancer after 12 months of completing neo-adjuvant or adjuvant therapy with Taxanes.
5. Subjects who have measurable disease in accordance with the RECIST criteria
Validation Durability Adenosine Effect in Verification Pulmonary Vein Isolation

Adenosine is used clinically to assess permanency of electrical isolation of pulmonary veins during atrial fibrillation ablation, however, the methodology has not been validated either in terms of the reproducibility of the adenosine response or the effect on clinical outcomes, namely whether using pulmonary vein reconnection to guide additional ablation lowers rate recurrent atrial fibrillation post ablation. Study will test the hypothesis that the response to adenosine used in this manner is reproducible over time.

Patients undergoing pulmonary vein isolation as part of atrial fibrillation ablation will be randomized to treatment and control groups. Treatment group subjects will received 12 mg IV adenosine to evaluate pulmonary vein reconnection after initial electrical isolation is documented. If electrical reconnection is not observed at 5 minutes, a second dose of adenosine will be administered, monitoring again for electrical reconnection. Control patients will be observed for 10 minutes post initial electrical isolation of the pulmonary vein for spontaneous electrical reconnection. If reconnection is observed, veins will be re-isolated per standard clinical practice. This procedure will be repeated for each of a patient's pulmonary veins. Patients will be followed up at clinical visits to examine for adverse effects of procedure and/or adenosine administration as well as atrial fibrillation recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing atrial fibrillation ablation, pulmonary vein isolation by catheter for standard clinical indications

Exclusion Criteria:

* allergy or contraindication to adenosine,
* inability to give informed consent,
* currently taking dipyridamole,
* verapamil or theophylline and
* breast-feeding mothers.
Evaluating the Efficacy of Opti-Speech for Speech Treatment

The purpose of this study is to determine if feedback from a three-dimensional real-time visualization of the tongue, a program called Opti-Speech, can be used to improve speech.

Participants will be asked to complete the Goldman Fristoe Test of Articulation along with several other assessment tests. Then speech treatment, guided by Opti-Speech, will be provided to the participant for up to 10 treatment sessions. The participant will be asked to come back after the final treatment for a 2-month follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

* English speaking individuals with speech errors resulting from persistent speech sound disorder, individuals with dysarthria resulting from neurological disorders and individuals with pre-lingual or congenital deafness.

Exclusion Criteria:

* Cognitive impairments that affect their ability to understand and follow instructions by the treating speech language pathologists
NPC Staged N2-3M0:Adjuvant Chemotherapy or Just Observation After Concurrent Chemoradiation

By this clinical trial, the investigators are trying to give an answer to such a question. Whether NPC patients staged N2-3M0 need adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation?

Recent research (Lancet Oncology 2012)shows that no survival benefits were achieved by adding adjuvant chemotherapy after concurrent chemoradiation in patients with locoregionally advanced NPC. But in patients with even high risk of distant metastasis(staged N2-3M0),is adjuvant chemotherapy necessary?

Eligibility Criteria:
Inclusion Criteria:

1. pathologically confirmed untreated NPC patients staged N2-3M0
2. age: 18y - 65y
3. with MRI examinations
4. ECOG≤2
5. with written consent

Exclusion Criteria:

1. without a second cancer
2. pregnancy
3. with other severe diseases(blood,liver ,kidney or heart diseases)
4. could not staged properly
5. without written consent
A Clinical Study to Evaluate Safety and Performance of PEEK-OPTIMA™ HA Enhanced.

The purpose of this trial is to collect clinical outcomes including radiographic and CT outcomes in patients who undergo spinal fusion using the Keos Lumbar Interbody Fusion Device.

This prospective, non-comparative, single-center, post-market trial will evaluate the safety and efficacy of the PEEK-OPTIMA ™ HA Enhanced Keos Lumbar Interbody Fusion Device in patients suffering from degenerative disc disease, spondylolisthesis and retrolisthesis in the lumbar spine. The trial will capture clinical outcomes, radiographic and CT outcomes over a 24 month period post operatively. One centre will be involved in the recruitment of 30 patients the clinic involved will focus on this type of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years of age or older.
2. Primary diagnosis of symptomatic degenerative disc disease (DDD) or symptomatic degenerative disc disease (DDD) with spondylolisthesis (Grade 1), or retrolisthesis, at one or two contiguous levels from L2 to S1.
3. Have discogenic back pain.
4. Suitable for transforaminal lumbar interbody fusion (TLIF) surgery.
5. Indicated for surgical treatment with the Keos Lumbar IBFD with autologous bone graft.
6. Completed at least 6 months of conservative non-operative treatment.
7. Female subjects of childbearing age must have a negative pregnancy test.
8. Able to understand this clinical study, co-operate with procedures.
9. Able to give voluntary, written informed consent to participate.

Exclusion Criteria:

1. Not undergone previous spinal surgery at the affected disc level(s).
2. Evidence of tumour and/or malignant disease.
3. Known osteoporosis or severe osteopenia.
4. Known rheumatoid arthritis, ankylosing spondylitis or who are immunocompromised.
5. Known allergy to the material used in the instrumentation.
6. Evidence of an active infection.
7. Any conditions outlined as contraindicated in the Instructions for Use.
8. Receiving any drug treatment that may affect bone metabolism.
9. Female subjects who are pregnant or lactating.
10. Current smokers or have stopped smoking less than 6 months ago.
11. Known drug or alcohol abusers.
12. Currently enrolled in a clinical study.
A Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Monotherapy in Patients With Rheumatoid Arthritis (MONACO)

This multi-center observational study will evaluate the use of RoActemra/Actemra (tocilizumab) in monotherapy in patients with rheumatoid arthritis. Eligible patients initiated on RoActemra/Actemra treatment according to the licensed label will be followed for 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Moderate to severe rheumatoid arthritis according to the revised (1987) ACR criteria
* Patients in whom the treating physician has made the decision to commence RoActemra/Actemra treatment in monotherapy, in case of methotrexate intolerance or when continuous methotrexate treatment is inadequate (in accordance with the local label), and who have received (or started) RoActemra/Actemra monotherapy treatment within 8 weeks prior to the enrolment visit.
* Concomitant corticosteroids (oral or intra-articular) or non-steroidal anti-inflammatory drugs (NSAIDs) are allowed

Exclusion Criteria:

* Patients in whom RoActemra/Actemra is contraindicated according to the approved Summary of Product Characteristics
* Patients who have received RoActemra/Actemra more than 8 weeks prior to the enrolment visit
* Patients who have previously received RoActemra/Actemra in a clinical trial or for compassionate use
* Concomitant DMARD treatment for rheumatoid arthritis (e.g. hydroxychloroquine, sulfasalazine, methotrexate, leflunomide, gold compounds, cyclosporine) when starting treatment with RoActemra/Actemra
* Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra
* History of autoimmune disease or any joint inflammatory disease other than rheumatoid arthritis
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology

This three parallel-arms, randomized, multicenter trial is aimed at investigating the value of AI-assisted optical biopsy for differentiating between neoplastic and non-neoplastic polyps which will lead to the implementation of cost-saving strategies in screening programs. A cost-effectiveness analyses with the use of modern trial emulation analyses of large observational and clinical trial datasets and real-cost data will be conducted. To improve personalized treatment with a novel colonoscopy CADx risk-prediction tool, the investigators will even develop a novel deep learning algorithm for the optical biopsy of the alternative pathway of colorectal cancer carcinogenesis, namely the serrated pathway and develop cost-effectiveness models of AI-assisted optical biopsy in colorectal cancer screening that provides reliable information to identify cancer risk regardless of physicians' skill.


Eligibility Criteria:
Inclusion Criteria:

* All \>40 years-old patients undergoing colonoscopy for selected indications

Exclusion Criteria:

* patients with personal history of CRC, or IBD
* patients affected with Lynch syndrome or Familiar Adenomatous Polyposis.
* patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale \<2 in any colonic segment).
* patients with previous colonic resection.
* patients on antithrombotic therapy, precluding polyp resection.
* patients who were not able or refused to give informed written consent.
Peer Support for Increasing Physical Activity in People With Serious Mental Illnesses

This study will determine the effectiveness of a peer support system in increasing physical activity and effecting health behavior change in people with serious mental illnesses.

People with serious mental illnesses (SMIs) are, by definition, significantly functionally impaired by the illness for an indefinite period of time. Schizophrenia, major depression, and bipolar disorder are considered SMIs. Severe anxiety disorders, cognitive disorders, and some personality disorders are sometimes categorized as SMIs, as well. The rate of obesity among people with SMIs is higher than that of people without mental illnesses. This disparity may be due to the negative symptoms that people with SMIs experience, such as vulnerability to stress, extreme dependency, and lack of motivation. This study will design and test a culturally appropriate physical activity intervention based on a peer support model for people with SMIs in an urban community psychiatry program. The intervention will be evaluated to determine its effectiveness in increasing physical activity and effecting health behavior change in people with SMIs.

Participants in this 4-month, open-label study will be randomly assigned to participate in either a physical activity intervention with peer support (PA+PS) or a physical activity intervention without peer support (PA). Participants in the PA+PS group will have three exercise sessions each week, which will include group exercise classes and open gym hours for supervised individual exercise. They will also meet with a peer educator once a week for 15 minutes. Peer educators will provide emotional, informational, instrumental, and appraisal support that is aimed to motivate participants to partake in the exercise sessions. Participants in the PA group will attend the three weekly exercise sessions but will not attend meetings with the peer educator. All outcomes will be assessed at a follow-up visit at the end of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patient at the Johns Hopkins Community Psychiatry program
* Plans to remain in Baltimore for 8 months after study entry
* If currently breastfeeding, has received approval from a physician to participate in the study

Exclusion Criteria:

* Any condition that would make weight loss medically inadvisable
* Diagnosis of or treatment for cancer (except non-melanoma skin cancer) within 2 years prior to study entry
* Liver failure
* History of anorexia nervosa
* Pregnant or planning to become pregnant during the study
* Inability to walk or participate in an exercise class
* Consumes more than 14 alcoholic drinks per week
* Symptoms of angina or a cardiovascular event within 6 months prior to study entry
Blood Loss During Cesarean Section. Comparing Two Techniques of Blunt Expansion of Uterine Incision: Transversal vs. Cephalad-caudad,

Obstetrical blood loss is an important reason of maternal morbidity and mortality. Because of the increase in the rate of cesarean section, any procedure that could help reduce blood loss during cesarean section should be investigated. The purpose of this study was to compare 2 methods of blunt expansion of the uterine incision at the time of cesarean delivery: transversal vs. cephalad-caudad.


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancies
* Gestational age: 34 weeks or more
* Delivery by cesarean section
* Presurgical hemoglobin \> 10.5 g/dL

Exclusion Criteria:

* Two or more previous cesarean sections
* History of uterine rupture in a previous pregnancy
* History of myomectomy
* History of abdominal trauma with an uterine lesion
* Blood dyscrasia
* Multiple pregnancy
* Placenta previa
* Abruptio placenta
* Stillbirth
* Sharp uterine expansion
High-dose Antioxidants for Central Serous Chorioretinopathy

Central serous chorioretinopathy (CSC) is the serous neurosensory detachment that usually involves the macular area. It is common in patients between 30-50 years old and effects male more often than female with the ratio of 5-10. The common risk factors are psychologic stress, type A personality, systemic steroid use, hypertension and pregnancy. The treatment is usually observation especially in the first three-months. The laser or photodynamic therapy should be considered when the condition does not improve after that time. Nevertheless, the pathogenesis of CSC is still not well understood but the study from indocyanine green angiography showed the choroidal vascular hyperpermeability and abnormal leakage. The causes of this abnormality are supposed to be from nitric oxide, prostaglandins or even free oxidative radicals. From this hypothesis, the oxidative process might be involved in the pathogenesis of the disease especially in the early stage. This study is to determine the effect of antioxidants drugs in the acute stage of CSC and to determine whether they can improve the outcomes of the disease.


Eligibility Criteria:
Inclusion Criteria:

1. patients with acute central serous chorioretinopathy within 6 weeks of onset
2. age between 30-50 years
3. new or recurrent attack (the symptom-free period should longer than 6 months)
4. fluorescein angiography (FA) confirmed the diagnosis with the inkblot or smoke-stack leakage and the optical coherence tomography (OCT) showed definite subretinal fluid
5. patients' ability for proper follow up.

Exclusion Criteria:

1. chronic central serous chorioretinopathy(longer than 6 weeks)
2. complicated central serous chorioretinopathy such as secondary choroidal neovascularization (CNV) that detected from FA
3. pregnancy, steroid user and patients that contraindicated for high dose antioxidants therapy such as heavy smokers, lung cancer, thyrotoxicosis, renal stone and anemia (hematocrit less than 30%).