cyrilzakka/clinical-trials huggingface dataset:
Precision Medicine Offers Belatacept Monotherapy

The purpose of this study is to determine the safety and feasibility of converting patients to Belatacept monotherapy (receiving just one immunosuppression drug), and to see what percentage of those patients can be safely converted to once every 8 week administration of Belatacept. Belatacept has been approved by the Food and Drug Administration (FDA) for kidney transplant recipients.

Patients on belatacept who fulfill the entry criteria will be screened to determine if they have a quiescent molecular immunologic profile with kSORT and uCRM. Patients who screen negative on all 2 tests will undergo stepwise withdrawal first of steroids then of MMF or mTor inhibitors. Prior to each withdrawal the 2 screening molecular tests will be performed and advancement to the next withdrawal phase will be performed if both are negative. Patients who are maintained on belatacept monotherapy with quiescent kSORT and uCRM and elevated kSPOT will be transitioned to q 8 weeks belatacept administration.

Forty patients who are previously enrolled in belatacept based regimens with a minimum of 7 years of follow up at 4 transplant centers and who are maintained on belatacept, an antiproliferative ± steroids will be approached for enrollment.

Drug withdrawal of steroids (in patients on steroids) and of antiproliferatives (MPAs or mTor inhibitors) will follow the design shown in the Study Schema. Patients who continue to be stable for 3 months on belatacept monotherapy will be converted from q 4 weeks to q 8 weeks belatacept administrations.

Eligibility Criteria:
Inclusion Criteria:

* Stable renal function with a GFR ≥ 35 ml/min
* No history of acute rejection
* A spot urine protein creatinine ratio of 0.5 or less
* No DSA

Entry: Biomarker criteria

* Blood kSORT and urine CRM tests that are quiescent at entry and following each drug withdrawal.
* A third biomarker KSPOT will be used to assess if any patients has achieved tolerance.

Eligibility for 8 week Belatacept Administration

* Trough levels of belatacept at 4 weeks of greater than 2 µg/ml
* Trough levels of belatacept at 8 weeks of equal or greater than 1 µg/ml

Exclusion Criteria:

* Patients with \< eGFR (35 ml/min)
* History of rejection
* Protein/creatinine rate \>0.5
* Presence of DSA
Arch Bars vs. IMF (Intermaxillary Fixation) Screws: Cost Effectiveness Based on Time Duration of Device Placement.

Determining the cost effectiveness, based on the time duration of application, of two methods of wiring the jaws together during surgery to repair mandible fractures. One technique is more expensive but faster in application, while the other is less expensive and takes more time to apply.

Purpose:

To identify which option of wiring the jaws together during treatment of mandible fractures is more cost effective to the patient, Erich arch bars or IMF (Intermaxillary Fixation) screws. Patients who sustain mandible fractures that meet the inclusion criteria will be randomized to one of the two treatment types listed above. The overall treatment in both categories is consistent with the standard of care, the only difference being the method utilized to achieve intermaxillary fixation during the course of the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-70
* Patients with no greater than one (1) open fracture of the tooth-bearing mandible
* Mandibular angle fractures ± Ramus or subcondylar fracture
* Body/symphysis ± subcondylar
* Isolated angle fracture
* Isolate subcondylar fractures
* Bilateral subcondylar fractures
* Any condylar head/neck fracture requiring treatment
* Patients who are candidates for treatment of their fractures in the operating room setting

Exclusion Criteria:

* Patients younger than 18 or older than 70
* Patients with developing tooth buds anterior to the second molars
* Patients with inadequate stability of occlusion
* Edentulism
* Unstable vertical and horizontal stops to the occlusion
* Patients with disorders affecting bone healing, metabolism and turnover
* Those patients on bisphosphonates, oral or IV
* Patients with evidence of intrabony pathology of the mandible or maxilla
* The presence of any of the following:
* Greater than one (1) open fracture of the tooth-bearing mandible
* Bilateral angle fractures are exempt from this
* Comminuted fractures of the mandible
* Concomitant infection, or osteomyelitis of the mandible
* Mechanism of injury
* Pathologic fracture
* Gun-shot wounds
Brentuximab Vedotin Followed by ABVD in Patients With Previously Untreated Hodgkin Lymphoma

The purpose of this study is to assess the efficacy of two three-weekly 1.8 mg/kg Brentuximab vedotin administrations in untreated patients with Hodgkin Lymphoma (HL).

This is a multicenter pilot phase II trial assessing 2 administrations of Brentuximab vedotin followed by PET scan and subsequent standard treatment with ABVD ± Radiotherapy. 12 patients defined by inclusion and exclusion criteria will be enrolled in one year. All subjects will be followed for disease evaluation every 3 months for one year after end of therapy until disease progression, death, initiation of alternative therapy, withdrawal of consent, or end of study. For all study procedures patient will be assigned a Unique Subject Identifier (SID) number that will be used to identify the subject during the screening process and throughout study participation. A master log will be maintained of all consented subjects and will document all screening failures (i.e. subjects who are consented but do not meet study eligibility criteria). Study records such as case report forms (CRFs) may be maintained electronically and require the same security and confidentiality as paper. Clinical information will not be released without written permission of the subject/legal representative, except as specified in the informed consent form

Eligibility Criteria:
Inclusion Criteria:

* Previously-untreated patients with classical Hodgkin Lymphoma according to the World Health Organisation (WHO) classification
* Histologically confirmed CD30+ HL
* Stage IA, IIA, IIIA
* Absence of bulky disease
* FDG-PET at baseline
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
* Life expectancy \> 6 months.
* Age 18-70 years.
* Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution.
* Females of childbearing potential must have a negative pregnancy test result within three days of enrollment. All patients must agree to use effective contraceptive methods (one for male and two for female) during the course of the study and for 6 months following the end of full treatment (Brentuximab vedotin + ABVD +/- Radiotherapy).
* Written informed consent.
* Required baseline laboratory data:

Absolute neutrophil count ≥ 1000/μl Platelet count ≥ 50.000/ μl Serum bilirubin ≤ 1.5 times ULN Serum creatinine ≤ 1.5 times ULN Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN

Exclusion Criteria:

* Peripheral neuropathy \> Grade 1
* Histologic diagnosis different from Hodgkin Lymphoma
* Compressive symptoms
* Patients previously treated with any anti-CD30 antibody
* Known human immunodeficiency virus (HIV) positive
* Known hepatitis B surface antigen-positive, or known or suspected infection active hepatitis C
* Patients with signs or symptoms of progressive multifocal leukoencephalopathy (PML)
* Patients with known cerebral/meningeal disease.
Return of Continence Following Robot-Assisted Radical Prostatectomy With or Without a Urethrovesical Sling

The purpose of this study is to determine the impact of an absorbable urethrovesical sling on the post-operative return of urinary continence after robot-assisted radical prostatectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have organ confined prostate cancer.
* Patients must have PSA\< 15.
* Patients must have clinical stage prostate cancer \< cT3.
* Patients must be scheduled for robot assisted transperitoneal laparoscopic radical prostatectomy.
* Patients must be able to provide written informed consent and HIPAA authorization for release of personal health information.
* Patients must be at least 18 years of age.

Exclusion Criteria:

* Patients must not have previously undergone transurethral resection, laser therapy, microwave therapy, radiofrequency ablation, or other surgery of the prostate.
* Patients must not have previously undergone incision of urethral stricture or incision of bladder neck contracture.
* Patients must not have previously been diagnosed with urethral stricture, bladder neck contracture or urinary incontinence.
* Patients must not have previously been diagnosed with atonic bladder or neurogenic bladder.
* Patients must not have significant pre-operative voiding symptoms as defined by an American Urologic Association symptom score of greater than 19.
* Patients must not have a prior history of radiation to the pelvis.
* Patients must not have persistent bacteriuria that cannot be cleared, as demonstrated by a negative urinalysis or urine culture, within 1 month of surgery.
* Patients must not have allergies to pig tissue or pig products or have religious or cultural objection to the use of pig tissue.
Evaluation of the Performance of MAgnetic Gastrointestinal Universal Septotome for Treatment of Candy Cane Syndrome

Candy cane syndrome (CCS) is an adverse event (AE) from gastrectomy or gastric bypass and end-to-side anastomosis to a jejunal loop. It seems to be predominantly mechanical, the afferent blind loop enlarge and becomes preferential passage of food. This food accumulated in the blind loop increase luminal pressure, causing dilatation, early satiety, fullness, pain, reflux, regurgitation, postprandial vomiting, weight loss, and, ultimately, inability to eat, leading to cachexia.Up to now, main treatment is laparoscopic revision which is invasive. Adverse events related this surgical procedure occurred in 13,3% of cases and substantial improvement only in 73.9%.

A first clinical study with MAGUS including oesophageal diverticulum (n=2) and CCS (n=14) has been performed to assess safety and feasibility of this new device. MAGUS is an implantable device which is placed endoscopically and which, by using pressure necrosis, entailed the marsupialization of the blind loop in less than 30 days. Substantial improvement was observed in all patient and only 7,1% of patients experience an adverse event possibly related to the device. This study aim therefore to assess the safety and performance of the endoscopic treatment of CCS using a new medical device: MAGUS.

This will be a single-center, open-label prospective, safety and performance study on 51 patients with Candy Cane Syndrome (CCS). Patients will be followed for 12 months after the procedure, with an enrolment period of 3 years.

After the screening, the following data will be collected and examinations and tests performed : physical Exam, medical history including CCS cause and treatment(s) history, weight, Eckart and dysphagia score, Quality of Life questionnaire (SF 12 and GERD HRQL), Main symptom selection (Nausea, Vomiting/regurgitation or pain), nausea VAS, vomiting, regurgitation VAS, pain VAS, barium swallow X-ray or endoscopic assessment of Candy Cane. Follow-up visits will be performed at 14 days, 28 days, 3 months and 12 months post-procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patient is diagnosed with candy cane syndrome based on clinical and endoscopic and/or radiologic assessment
* Patient has at least one of this 3 symptoms associated to CCS: pain, nausea, vomiting, regurgitation
* Patient agrees and is able to comply with the study procedures and provide written informed consent to participate in the study

Exclusion Criteria:

* Refractory stenosis of the UGI proximal to the septum
* Septum height smaller than 2 cm or higher than 8 cm
* Coagulation disorders.

  • Previous implantation of a magnetic-sensitive medical device (including active electronic implant, metallic stent, ...).
* Dysphagia related to motility disorder
* Planned MRI in the following month (30 days) of intervention
* Condition that could compromise patient safety
* Patient who went through an abdominal surgery less than 8 weeks before implantation of the magnets
* Patient pregnant, breastfeeding or incapacitated
* Patient currently enrolled in another clinical trial
Intraoperative Warming During Major Surgical Procedures Using the Esophageal Temperature Management System

The aim of this study is to assess the effectiveness of EnsoETM as a supplemental warming device compared to the standard of care warming practice in patients having major surgery.

Maintaining patient's body temperature is of major importance in patients undergoing surgical procedures and existing methods to warm patients to maintain perioperative normothermia have limitations. This results in as many as half of patients undergoing surgery developing inadvertent hypothermia during and/or after their procedure. The EnsoETM is an Esophageal Temperature Management (ETM) device consisting of a multi-chambered silicone tube connected to a heat exchanger and placed in the esophagus, providing highly efficient heat transfer to a patient. The EnsoETM potentially improves the ability to control patient temperature by eliminating the disadvantages of existing methods while maintaining the functionality of the orogastric tube that it replaces.

The primary objective of this study is to measure the number of degree-hours spent below 37°C intraoperatively and until recovery in the PACU. This measure will be compared between patients having standard management of body temperature to patients having the EnsoETM placed as an additional warming device.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Male or female, ages 18 years and older
* Scheduled for major surgical procedures requiring general anesthesia and with no known contraindication to having an orogastric tube placed for the duration of the surgery
* The time in the OR is expected to last at least 180 minutes

Exclusion Criteria:

* Esophageal strictures (risk of perforation)
* Patients with known esophageal deformity or evidence of esophageal trauma (for example history of esophagectomy, previous swallowing disorders, achalasia, etc.)
* Known ingestion of acidic or caustic poisons within the prior 24 hours.
* Patients with \<40 kg of body mass
* Coagulopathy
* Severe facial trauma
* Surgical procedures lasting less than 3 hours
PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370)

The objective of this study is to determine the effectiveness of PEG-Intron 1.5 ug/kg/wk plus REBETOL (ribavirin) 800-1400 mg/day in adults with chronic hepatitis C with moderate to severe liver fibrosis or cirrhosis who failed to respond to previous treatment with an alpha interferon in combination with ribavirin. Patients who do not respond to PEG-Intron plus REBETOL (ribavirin) will be enrolled in a long-term maintenance study to evaluate the effectiveness of PEG-Intron monotherapy versus no treatment for the prevention of disease progression (Protocols P02569 and P02570).


Eligibility Criteria:
Inclusion Criteria:

* Age at entry 18-65
* Positive for Hepatitis C
* Nonresponder to previous treatment (minimum of 3 months) with an alpha Interferon plus ribavirin
* Liver biopsy demonstrating moderate to severe fibrosis or cirrhosis

Exclusion Criteria:

* Any cause for the liver disease other than chronic hepatitis C
* History or presence of complications of cirrhosis
* Alcohol or illicit drug use or methadone treatment within the past 2 years
* Treatment for chronic hepatitis C within the previous 6 months
* Diseases or conditions that could interfere with the subject's participation in and completion of the study
Prevalence Study and Regular Practice Among General Practitioners in Populations at Risk of Chronic Obstructive Pulmonary Disease (COPD) in Latin America

PUMA is an observational, multicentre, multinational, cross-sectional study with primary care physicians (primary care, general and family physicians). Participants will be selected sequentially among patients at risk for Chronic Obstructive Pulmonary Disease (COPD) who attend primary care consultation (primary care, general and family physicians). The inclusion visit will be a regularly scheduled or spontaneous consultation for patients, and this appointment with the physician will not depend on the study. During the appointment, data will be collected from the patient and the physician.

PREVALENCE STUDY AND REGULAR PRACTICE (DIAGNOSIS AND TREATMENT) AMONG GENERAL PRACTICIONERS IN POPULATIONS AT RISK OF COPD IN LATIN AMERICA

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged more or equal than 40
* Current or former smokers and/or patients exposed to biomass combustion:

Cigarettes: more or equal than 10 packs/year; Pipes: more or equal than 50 pipes/year; Cigars: more or equal than 50 cigars/year; Combustion: more or equal 100 hours/firewood/year

Exclusion Criteria:

* Pregnancy
* Patients with contraindications for spirometry
* Physical or mental disability rendering the patient unable to undergo a spirometry test and to contribute data to the study
* Heart rate ≥ 120 beats by minute
* Patients currently undergoing treatment for tuberculosis
* A patient who is participating in an interventional clinical trial or was previously included in this study
The Gastric Cancer Foundation: A Gastric Cancer Registry

The Gastric Cancer Registry will combine data acquired directly from patients with gastric cancer; with a family history of gastric cancer in a first or second degree relative; or persons with a known germline mutation in their CDH1 (E-Cadherin) gene via an online questionnaire with genomic data obtained from saliva, blood and tissue samples. The purpose of this registry is to gain better understanding of the causes of gastric cancer, both environmental and genetic; whether certain genomic data can predict outcomes of treatment and survival.

Collect detailed clinical and epidemiological information on eligible patients via an online registry and a detailed patient questionnaire. Participants can opt in to contribute a blood or saliva sample and paraffin block samples from a previous gastric surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Patients are eligible if they have a histologically proven gastric tumor including gastroesophageal tumors; OR they have a family history of gastric cancer in a first or second degree relative; OR persons with a known germline mutation in their CDH1 (E-Cadherin) gene.
2. 18 years of age or older
3. Adequate English proficiency to complete online consent and questionnaire. Spanish-language proficiency as an alternative to English-language proficiency.

Exclusion Criteria:

1. Under 18 years of age
2. No history of gastric cancer or gastric cancer in a family member or a known germline mutation in their CDH1 gene.
Hepatoprotective for Children and Adolescent With Acute Lymphoblastic Leukemia

This current study will implement a proposed whole program of monitoring and prevention acute hepatic injury during the time of induction chemotherapy in children and adolescent with ALL.

Children and adolescent with acute lymphoblastic leukemia (ALL) can exhibit a wide spectrum of hepatotoxicity ranging from asymptomatic to clinically significant during induction chemotherapy. Unmonitored hepatic status can lead to a hepatic toxicity that might result in unwarranted interruption of the aimed delivery of dose dense chemotherapy to induce remission and consequent treatment.

To evaluate the effect of chemotherapy in children and adolescent with ALL during induction phase, through recording liver function tests before, during and after induction chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

Children and adolescents aged from 2 to 18 years newly diagnosed with acute lymphoblastic leukemia during induction phase of chemotherapy treated at Ain Shams

Exclusion Criteria:

Known chronic liver disease.
Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients

The purpose of this study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, mycophenolate mofetil (MMF) and a rapid steroid withdrawal.

A 2 arm (1 Active, 1 Active Control) study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, MMF and a rapid steroid withdrawal.

Eligibility Criteria:
Inclusion Criteria:

* Recipient of a primary or re-transplanted deceased donor kidney or a primary or re-transplanted non-human leukocyte antigen (HLA) living donor kidney (ie., HLA identical or 0 antigen mismatch deceased donor kidneys are allowed).

Exclusion Criteria:

* Patient has previously received an organ transplant other than a kidney
* Patient receiving chronic steroid therapy at time of transplant
Dynamic 68Ga-PSMA and 18F-FDG PET/CT Analysis Prior to 177Lu-PSMA

Prostate cancer is a significant health issue, representing 21.8% of male cancer cases in France with over 449,000 new cases in 2018. It's the cause of 10% of cancer deaths in Europe.

The PSMA is a target for mCRPC treatment, with therapies like 177Lu-PSMA-617 delivering radiation to cancer cells. The Vision study showed that 177Lu-PSMA-617, combined with standard care, improved survival rates significantly compared to standard care alone.The French ANSM authorized 177Lu-PSMA-617 for mCRPC under certain conditions. Patients must have histologically confirmed mCRPC, be progressive despite treatment, and have PSMA-positive imaging.

Imaging assessments include PSMA PET/CT and 18F-FDG PET/CT to identify FDG-positive and PSMA-negative sites, which are associated with a poorer prognosis.

Parametric analysis using dynamic PET could improve lesion characterization, aiding in treatment decisions. This is the focus of the PyPET study.

The main objective focuses on a comparative analysis of data from dynamic parametric analysis (metabolic influx rate Ki, volume of distribution Vd) and static analysis (standard at 1 hour) using 18F-FDG and 68Ga-PSMA PET/CT for diagnosing metastases, especially in the liver, lymph nodes, and bones. It aims to assess the effectiveness of these imaging techniques in accurately identifying metastatic sites.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* Progressive metastatic castration-resistant prostate adenocarcinoma, which has been treated with taxane chemotherapy and at least one anti-androgen hormone therapy.
* Evaluated by 18F-FDG and 68Ga-PSMA PET/CT prior to potential treatment with 177Lu-PSMA.
* Affiliated with or beneficiary of a social protection scheme.
* WHO stage 0 or 1.

Exclusion Criteria:

* Patients unable to understand the study for any reason or comply with the trial requirements (due to language barriers, psychological issues, geographical constraints, etc.).
* Patients unable to undergo the examinations and/or maintain a prolonged lying position (due to back pain, etc.).