cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of Web-Based Training (SERT)

The objective of this research study is to assess the effectiveness of an independent transfer training program (ITTP), and to determine methods which may increase overall success of an online training program.

Up to 200 individuals will be recruited for this research study. Investigators will recruit individuals who use a wheelchair for the majority of their mobility (over 40 hours per week), have the ability to transfer independently (may use equipment like sliding boards), use a seated pivot to transfer, and speak English as a primary a language. This study will be accessed entirely online and participation is expected to last approximately one year. Subjects will be randomized into three groups; one group that will receive transfer training immediately with no follow up, one group that will receive the transfer training immediately with 1 month and 6 month follow up, and one group that will receive the transfer training after 6 months. The transfer training program itself will take approximately 1 hour to complete.

After obtaining informed consent, participants in the first two groups will complete baseline questionnaires. They will then receive the transfer training program.

Participants in the third group (a wait-list control group) will complete the baseline questionnaires and be contacted one month later to complete a transfer assessment instrument questionnaire. They will then wait 5 months. After this period, participants will complete the baseline questionnaires a second time, and then receive the transfer training.

After completing the transfer training, all groups will be contacted immediately post training to complete additional questionnaires to assess the effectiveness of the remote transfer training program. Participants in the 2nd and 3rd group will be contacted 1 month and 6 months post-training to complete additional questionnaires.

Eligibility Criteria:
Inclusion Criteria:

1. Utilize a wheelchair for the majority of mobility (over 40 hours per week).
2. Ability to transfer independently (may use equipment like sliding boards).
3. Use of seated pivot transfer
4. Speak English as a primary a language

Exclusion Criteria:

1. Pain prohibiting transfers
2. Active use of the lower limb muscles during transfers
3. Current or recent history (last 3 months) of pressure sores
Screening for Atrial Fibrillation in Pulmonary Embolism Study -SAFE-PE Study

Patients with newly diagnosed pulmonary embolism and high thromboembolic risk will be randomized to screening for atrial fibrillation or standard of care using intermittent ECG registration for at least two weeks.

Patients included in the study might be referred for an ultrasound of deep vein thrombosis unless this has already been performed. Blood will be drawn in a subset of patients to assess cardiac biomarkers, and stored in a biobank for further analysis of thrombotic biomarkers. If a computed tomography (CT) angiogram was used as diagnostic method for pulmonary embolism a radiologic review will be performed to assess presence of right atrium thrombus, with the reviewer will be blinded to the presence of atrial fibrillation (AF). In addition, an echocardiogram of the heart will be performed.

Many patients with pulmonary embolism have prolonged symptoms of dyspnoea, and palpitations. These symptoms are also described in patients with atrial fibrillation. All participants will be asked to fill out a standardized quality of life (RAND-36)-, and a symptoms questionnaire (modified European Heart Rhythm association symptom scale). Upon inclusion all patients will be reviewed for factors predisposing to PE such as recent surgery, or illness requiring immobilisation within the past three months prior to index event.

After inclusion patients will be randomised to screening for atrial fibrillation or standard of care. Participants who get randomised into the screening arm will be screened for AF using a validated, handheld ECG device at least twice daily for two weeks. Participants who get AF diagnosed during the study will be referred for appropriate cardiology follow-up and the anticoagulant therapy will be changed from a fixed time to continued (subject to yearly reviews). Patients will then be followed for five years using the Swedish death registry, and the Swedish national patient registry, in combination with the national prescription registry for the outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Recent pulmonary embolism (within three months)

Fulfilling Chads-Vasc criteria for life-long oral anticoagulant therapy (2 points for men, and 3 points for women), or age \> 65 years

Exclusion Criteria:

* Known diagnosis of atrial fibrillation Contra-indication to oral anticoagulant therapy Provoked pulmonary embolism in sub-segmental artery only Active cancer therapy (on-going therapy, recent surgery or life-expectancy below 1 year)
Nitrocamptothecin in Treating Patients With Recurrent Non-small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of nitrocamptothecin in treating patients who have recurrent non-small cell lung cancer.

OBJECTIVES: I. Determine the response rate, time to progression and overall survival of patients with recurrent non-small cell lung cancer when treated with nitrocamptothecin. II. Assess the toxicities and pharmacokinetics of this regimen in these patients.

OUTLINE: Patients receive oral nitrocamptothecin daily on days 1-5. Treatment continues weekly in the absence of disease progression or unacceptable toxicity. Patients are followed for survival.

PROJECTED ACCRUAL: A total of 20-55 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed recurrent non-small cell lung cancer No more than one prior chemotherapy treatment Bidimensionally measurable disease No prior radiotherapy to target lesion OR Progression since prior radiotherapy

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2.0 mg/dL ALT/AST no greater than 3 times upper limit of normal (ULN) (no greater than 5 times ULN in case of liver metastases) Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 50 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No uncontrolled serious medical or psychiatric illness

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered No prior camptothecin Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy and recovered Surgery: At least 2 weeks since prior major surgery
Effect of Antigens or Therapeutic Agents on in Vitro Human Intestinal Organoids

The study evaluates the effect of nutrient antigens or therapeutic agents on human small intestinal organoids.

Small intestinal biopsies will be taken to establish human intestinal organoids in vitro. The organoids will be propagated and various antigens will be checked for their effects on proliferation, production of inflammatory components or signal cascade.

Eligibility Criteria:
Inclusion Criteria:

* patients with gastrointestinal disorders and therapeutical indication of gastroduodenoscopy or coloscopy
* healthy controls for preventive medical check-up

Exclusion Criteria:

* pregnant women
Multi-Center Study of the NDO Surgical Plicator Utilizing Multiple Implants for the Treatment of GERD

The purpose of this study was to evaluate the safety and efficacy of placing multiple transmural sutures for the treatment of GERD.

A prospective, multi-center, open-label trial was conducted at four centers in Germany to evaluate a modified Plicator technique for the treatment of patients with symptomatic GERD. Primary efficacy was based on analysis of the GERD Health Related Qualify of Life (HRQL) questionnaire at 6-months post-treatment. Additional efficacy outcomes assessed were heartburn and regurgitation symptoms scores, visual analog scale (VAS) score, GERD medication use, esophageal pH/manometry, and esophagitis. Trial sample size was chosen to provide 87% power in detecting a 50% median reduction in GERD-HRQL score at an alpha level of 0.05.


Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years of age or older.
* History of heartburn or regurgitation for at least 6 months.
* Esophageal manometry study (conducted within the previous 6 months) demonstrating an adequate resting pressure of the lower esophageal sphincter (LES) of at least 5 mm Hg.
* pH study (conducted within the previous 6 months) demonstrating pathological reflux (defined as the total % time of pH\<4.0 \> 4.5% or a DeMeester composite score \> 14.7).
* Symptoms requiring daily PPI therapy.
* GERD-HRQL scores must be \> 15 while Off Medication and Off Medication scores must be \> 6 points higher than On-Medication scores.
* Subject is a surgical candidate in the event of a complication related to this procedure, Class ASA I or II.
* Subject agrees to participate and signs consent form.

Exclusion Criteria:

* Patient is pregnant.
* Patient has hiatal hernia \> 3 cm.
* Presence of persistent dysphagia, weight loss, esophageal bleeding, vomiting (\>1 per week) or gas/bloat.
* Esophagitis grades III or IV by Savary criteria.or type C or D by Los Angeles classification .
* Barrett's esophagus with dysplasia.
* Patient has had a previous endoscopic (Endocinch, Stretta, Enteryx, etc.) or surgical repair (Nissen Fundoplication, etc.) performed to treat GERD.
* Active medical condition that would preclude the subject from finishing this study.
* Abnormal blood coagulation or the chronic use of anticoagulant or platelet anti-aggregation therapy (other than for cardiac prophylaxis).
* Pathological changes in soft tissue that would prevent secure fixation of the EPS Implant.
* Presence of esophageal or gastric varices.
* Esophageal dysmotility as determined by manometry studies.
* Esophageal stricture.
Assessment of the Development of Postoperative Persistent Postoperative Pain

During the postoperative period, it is possible to observe the development of acute pain, which lasts no longer than a week after surgery. However, sometimes some patients see the prolongation of this pain beyond the healing time of the tissue, turning into a chronic condition. Persistent postoperative pain is a disease with a complex and still unknown etiology, affecting between 5 and 75% of the population. The development of persistent postoperative pain is a rather important issue since the physician managing the patient must on the one hand ensure adequate analgesia, and on the other hand, minimize the risk of continued opioid use in the case of chronicization.

In a study conducted analyzing the prevalence of persistent postoperative pain in various surgeries it was seen to occur more frequently in limb amputation (prevalence \>85%), thoracotomy (prevalence 48%), knee arthroplasty (prevalence 44%), laminectomies, and spinal arthrodesis (prevalence 5-46%), and hip replacement (prevalence 27%) making this type of pain more frequent in the patient undergoing orthopedic surgery.

As the mechanisms behind its development have not yet been fully clarified, efforts to study the clinical factors associated with the onset of this pathology have been attempted.

As there is no way in the literature to stratify the risk of the population in order to prevent the development of postoperative pain, based on the variables reported by different studies, it was decided to administer in patients referred to the Orthopedics and Traumatology 1 U and Orthopedics and Traumatology 3 U department at the Orthopedic Trauma Center of Turin questionnaires to assess the development of chronic pain for screening purposes and to contribute to the improvement of the long-term management of these patients in the postoperative period.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing orthopedic surgery considered at high risk of developing persistent postoperative pain (i.e. knee prothesic surgery, hip prothesic surgery, spine fusion surgery)

Exclusion Criteria:

* Patients undergoing redo prothesic surgery
* Trauma patients
Clinical Investigation of the Freedom SOLO Stentless Heart Valve

This is a trial to demonstrate the safety and effectiveness of the Freedom SOLO heart valve when used to replace a diseased or dysfunctional aortic valve or aortic valve prosthesis.

Freedom SOLO study is a prospective, non-randomized, multicenter trial on the Freedom SOLOvalve implanted in patients requiring aortic valve replacement. The study was conducted at 18 centers in Europe.

The study was based on single sample hypothesis testing that allows comparison of observed morbid event rates to objective performance criteria (OPCs). Based on the guidelines established by the U.S. Food and Drug Administration (FDA), the minimum sample size for this study was 800 valve-years, which is the minimum amount of data needed to test against the OPC of 1.2 %/patient-year.

Eligibility Criteria:
Inclusion Criteria:

* The patient is male or female 18 years old or older.
* The patient is willing to sign the informed consent.
* The patient which preoperative evaluation indicated the need for native or prosthetic aortic valve replacement.
* Any patient amenable to aortic valve replacement with biological prosthesis should be enrolled in the study, even in conjunction with valve repair, coronary artery bypass grafting and other procedures.
* The patient is located in a geographic location that will enable the subject to return to the study site for all follow-up examinations (i.e. geographically stable).
* Patient will be available to the investigator(s) for postoperative follow-up beyond one year.

Exclusion Criteria:

* The patient has preexisting valve prosthesis in the mitral, pulmonary or tricuspid position.
* The patient requires a double or triple valve replacement (a valve repair is not considered an exclusion criterion).
* The patient has a previously implanted SOLO valve, within the clinical study, that requires replacement.
* The patient has active endocarditis.
* The patient is or will be participating in a concomitant research study of an investigational product.
* The patient is a minor, intravenous drug user, alcohol abuser, prisoner, institutionalized, or is unable to give informed consent.
* The patient has a major or progressive non-cardiac disease that, in the investigator's experience, results in a life expectancy of less than 1 year, or the implant of the device produces an unacceptable increased risk to the patient.
* The patient is pregnant or lactating.
* Patients with congenital bicuspid aortic valve.
* Patients are known to be noncompliant or are unlikely to complete the study.
The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer

This is a randomized, placebo-controlled, multi-center, double blinded, Phase III study to determine the efficacy and safety of TORIPALIMAB INJECTIO（JS001） in combination with gemcitabine/cisplatin compared with placebo in combination with gemcitabine/cisplatin as first-line treatment in patients with histological/cytological confirmation of recurrent or metastatic NPC. The primary endpoint is PFS in all patients. Approximately 280 patients who fulfill all of the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to one of the two treatment arms. patients will be randomly assigned to the combination of JS001 (Arm A) or placebo (Arm B) with gemcitabine and cisplatin given every 3 weeks (Q3W) in 3-week cycles.

Total 289 patients were enrolled and randomized in a 1:1 ratio to the group of JS001 (Arm A) with gemcitabine and cisplatin or placebo (Arm B) with gemcitabine and cisplatin every 3 weeks (Q3W) in the 'during chemotherapy' phase. During the 'post-chemotherapy' phase, patients randomized to Arm A or Arm B will continue treatment with JS001 or placebo as maintenance therapy Q3W until excessive toxicity or progressive disease, withdrawal of consent or Investigator's judgement or a maximum of 2 years. Tumor evaluation scans will be performed at screening (as baseline) then every 6weeks in the first 12 months then every 9 weeks thereafter until objective disease progression. The primary objective is to compare PFS as assessed by the IRC in ITT population (all randomized patients).

Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥ 18 years and ≤75 years.
* 2. Histological/cytological confirmation of NPC.
* 3. Primarily metastatic (stage IVB as defined by the International Union against Cancer and American Joint Committee on Cancer staging system for NPC, eighth edition) or recurrent NPC that is not amenable for local regional treatment or curative treatment.
* 4. At least 1 measurable lesion according to RECIST version 1.1.
* 5. Life expectancy ≥ 3 months

Exclusion Criteria:

* 1. History of severe hypersensitivity reactions to other mAbs or any ingredient of JS001.
* 2. Prior therapy targeting PD-1 receptor, or its ligand PD-L1, or cytotoxic T lymphocyte associated protein 4 (CTLA4) receptor.
* 3. Major surgical procedure other than for diagnosis of NPC within 28 days prior to randomization or anticipation of need for a major surgical procedure during the study
* 4. History of hypersensitivity to gemcitabine or cisplatin or to any of the excipients.
* 5. Female patients who are at pregnancy or lactation.
Plasma Disc Decompression Versus Conservative Care

The purpose of this study is to compare the plasma disc decompression (PDD) procedure to conservative care (physiotherapy) for the treatment of patients with radicular pain originating from a disc protrusion. Treatment efficacy and rate of improvement is evaluated at 8 weeks after treatment start and followed-up for 1 year after treatment start.


Eligibility Criteria:
Inclusion Criteria:

1. Patient has one symptomatic contained, focal herniated lumbar disc.
2. Patient's age should be at least 18 years old and no more than 65 years old.
3. A VAS score for radicular pain of 50 or greater on a scale of 0 to 100.
4. Radicular pain concordant with image findings (MRI/CT not older than 12 months).
5. Disc height greater or equal to 50% of expected height in the range of a patient's normal anatomic variations and expected changes due to age.
6. Patient signs informed consent.

Exclusion Criteria:

1. Patient is pregnant, or pregnancy is suspected or planned within the study timeframe.
2. Patient has a cardiac pacemaker, automatic defibrillator, or any peripheral stimulator leads in the lumbar area.
3. Allergy to contrast media or drugs to be used in the intended procedure.
4. Medical co-morbidities that preclude surgical intervention.
5. Patient is receiving anti-psychotic therapy.
6. Patient is a prisoner.
7. Patient is incapable of understanding or responding to the study questionnaires.
8. History of previous spinal surgery at, or directly adjacent to, the level to be treated.
9. Patient is morbidly obese (BMI ≥ 40).
10. Patient is simultaneously participating in another device or drug study related to limb/axial pain.
11. Patient has a spinal fracture, tumor or infection.
12. Radicular pain originating from more than one disc level.
13. Axial (back) pain greater than radicular (leg) pain.
14. Clinical evidence of cauda equina syndrome.
15. Progressive neurologic deficit.
16. Radiological evidence of spondylolisthesis at the level to be treated.
17. Radiological evidence of moderate/severe stenosis at the level to be treated.
18. Evidence of extruded or sequestered disc herniation on magnetic resonance imaging.
Withdrawal of Steroids, Cyclosporine A Dose Reduction and Switch to Mycophenolatmofetile After Heart Transplantation

The purpose of this study is first to improve or save renal function and second to decrease cardiac risk factors by optimising the immunosuppressive regimen by withdrawing steroids and reducing the Cyclosporine A dose. The concomitant administration of Mycophenolatmofetile, an effective immunosuppressive agent, will minimize the risk of acute rejection episodes.

The decrease of quality of life in patients after heart transplantation in the long-term is determined by an increasing incidence of transplant vasculopathy and by immunosuppression-related side effects. Calcineurin inhibitors are associated with chronic nephrotoxicity, while long-term administration of steroids results in an increased incidence of cardiovascular risk factors (e.g. hypertension, lipometabolic disorders, steroid induced diabetes, adipositas)and therefore, carries the potential of graft disfunction.

Eligibility Criteria:
Inclusion Criteria:

* Current immunosuppressive regimen: Cyclosporine A and corticosteroids for at least six month
* Heart transplantation above 3 years dated back
* Serum creatinine \< 3,5 mg/dl (310 µmol/l) and BUN \< 150 mg/dl
* Cyclosporine A blood level between 50 and 250 ng/ml during the last 12 month

Exclusion Criteria:

* Carcinoma within the last 3 years
* Acute rejection episodes during the last 6 month
* Infection requiring therapeutic intervention
* Hepatitis B, Hepatitis C or HIV infection
* WBC \< 3000/µl, haemoglobin \< 9g/dl, platelets \< 70.000/µl
* Florid gastrointestinal ulcer
* Haemodialysis within the last 4 weeks before study entry
* Pregnancy / lactation
* Administration of other immunosuppressive agents than prescribed
* Mycophenolatmofetile incompatibility
Differences in Morbidity Between a Necessity Endotracheal Suctioning Protocol Versus a Routine Endotracheal Suctioning

Morbidity frequency associated to a endotracheal suctioning is different between a necessity endotracheal suctioning protocol versus a routine endotracheal protocol.

Endotracheal aspiration is a very useful procedure. It has several adverse events every time that aspiration is practiced. This trials wants to identify which protocol (necessity versus routine) could be better to practice in pediatrics intensive care unit with less risk.

Eligibility Criteria:
Inclusion Criteria:

* Children older than 1 month until 14 years old requiring orotracheal intubation

Exclusion Criteria:

* High frequency ventilation mode