cyrilzakka/clinical-trials huggingface dataset:
Indications for Osteochondral Allograft Transplantation

With IRB approval, a prospective single-cohort clinical trial will be performed to assess safety and efficacy of total biologic arthroplasty of the ankle. With informed consent, patients (n=10) who require tibio-talar arthroplasty based on physical examination and diagnostic imaging will be enrolled. Primary criteria for inclusion will be Grade IV changes in the articular cartilage of the tibial plafond and/or talar dome as determined by physical examination, diagnostic imaging and/or arthroscopy by the attending surgeon. Exclusion criteria include acute injury to any other part of the affected lower extremity or inability to comply with the protocol.

After enrollment, patients will undergo standard ankle radiography and complete assessments (described below). Size-matched (standard clinical methodology) MOPSTM allografts (Musculoskeletal Transplant Foundation, Edison, NJ) from the same donor will be obtained to treat the entire tibiotalar joint. The affected joint will be treated with OCA transplants using our current technique and instrumentation. Osteochondral grafts including MOPSTM OCAs are regulated under U.S. Food and Drug Administration (FDA) section 361 of the Public Health Service Act and 21 Code of Federal Regulation 1271 that defines human cells, tissues or cellular or tissue based products (HCT/P).

Patients will follow a managed post-operative rehabilitation protocol that is standard for those that have had an osteochondral allograft to their ankle.

Range of motion and patient-reported outcome measures (PROMs) including VAS pain score, AOFAS, and PROMIS Mobility as well as complete radiographs (XR) of the affected ankle will be obtained prior to surgery and at 6 weeks, 3 months, 6 months, and 12 months after surgery to evaluate healing, function and evidence for arthrosis. MRIs for cartilage composition (12 months after surgery, and serum and urine biomarkers for treatment monitoring (preop, 6 and 12 months after surgery) will be performed. We will document all adverse events and complications, including joint or incision infection, graft failure, hardware failure, and arthrofibrosis. Patients with a VAS pain score \>5 beyond 3 months postoperatively or clinical or diagnostic imaging evidence for nonunion or graft collapse will undergo MRI of the ankle to determine the appropriate clinical course of action. OCA survival will be determined based on maintenance of acceptable levels of pain (\<2 VAS) and function and/or need for revision surgery or total ankle arthroplasty, fusion, or amputation.


Eligibility Criteria:
Inclusion Criteria:

i. Grade IV changes in the articular cartilage of the tibial plafond and/or talar dome as determined by physical exam, diagnostic imaging, and/or arthroscopy by the attending surgeon ii. Between the age of 18-55

Exclusion Criteria:

i. Acute injury to any other part of the affected lower extremity ii. Inability to comply with protocol iii. BMI greater than 40 iv. The subject is either pregnant or a prisoner v. Currently involved in worker's compensation case at the time of enrollment
Evaluation of Practices of ECMO or ECLS and Ethical Implications in France

Short-term circulatory support (ECMO/ECLS) has become a common emergency resuscitation support.

Currently, the indication of the ECMO/ECLS relies more on clinic, biological and imagery arguments than on a real consensus.During the care of a patient under ECMO/ECLS, various stakeholders are involved in the implementation and its medical and paramedical management. Everyone, with their knowledge and experience, has an opinion on the relevance of this therapy.

A validated questionnaire, translated from an Anglo-Saxon study, will be used as a basis for work and adapted. After the publication of a memo, it is accessible anonymously on a platform (ASKABOX) whose link is distributed by email by the secretaries or nursing staff. The city and the exercise service will be requested in the preamble of the questionnaire. It is composed of six demographic questions: age, gender, occupation, participation in emergency care, number of ECMOs encountered, level of knowledge about ECMO. The other questions concern concrete ECMO situations and the answers are nuanced from definitely yes to definitely no to allow professionals to express their opinion as well as possible. The targeted professionals are all those involved in the management of patients on ECMO: emergency physicians, anesthesiologists, surgeons, perfusionists, nurses, orderlies, ASHs.

A monocentric feasibility study was carried out with satisfactory results in terms of participation.

AN INFORMATION NOTE WILL BE ATTACHED WITH THE EMAIL AND THE LINK FOR THE QUESTIONNAIRE (ANONYMOUS)

Eligibility Criteria:
Inclusion Criteria:

* All medical and paramedical personnel involved in decision making, installation, and monitoring of the ECMO

Exclusion Criteria:

* MEDICAL AND PARAMEDICAL STAFF NOT INVOLVED IN THE ESTABLISHMENT OR FOLLOW-UP OF THE ECMO
Telemetric Arrhythmia Diagnosis in Adults

The purpose of this study is to assess efficacy of prolonged Full Disclosure electrocardiogram (ECG) monitoring and signal analysis using advanced telemetric technology in comparison with a standard Holter ECG recording and an Event Holter recording to diagnose cardiac arrhythmia.

Irregular and/or rapid beating of the heart called heart palpitations can occur in individuals without heart disease and the reasons for their palpitations are unknown. Together with heart palpitations silent arrhythmia may be present that could lead to serious complications (eg. stroke). In others, palpitations result from heart rhythm disturbances, sometimes life threatening. Standard diagnostic methods such as 24 hours Holter ECG monitoring or Event Holter do not guarantee early diagnosis of the arrhythmia. Prolonged heart rhythm recording and analysis using an automatic full disclosure telemetric device increase probability of arrhythmia diagnosis and early administration of applicable treatment. Study patients will be diagnosed using standard Holter ECG monitoring and 14 days telemetric full disclosure ECG monitoring. The full disclosure signal will be subsequently analyzed in the Event Monitoring mode by an independent consultant. Efficacy of Telemetric Monitoring in diagnosis of cardiac arrhythmia will be assessed in comparison with the standard Holter monitoring and Event Monitoring.

Eligibility Criteria:
Inclusion Criteria:

* Age - between 18 and 80 years old
* History of symptoms potentially caused by arrhythmia
* Symptoms occuring at least monthly
* Patient informed consent
* Declarative and feasible compliance (patient understands basic instructions regarding device use)

Exclusion Criteria:

* Evidence of previously recorded arrhythmia
* Inability to comply with the study protocol
* Lack of patient cooperation
Ticagrelor Antiplatelet Therapy to Reduce Graft Events and Thrombosis

Saphenous vein graft disease remains an unresolved medical problem. Many vein grafts occlude in the first year after bypass surgery, leading to adverse cardiovascular outcomes, including recurrent angina, myocardial infarction, and the need for repeat coronary intervention. While aspirin is the standard antiplatelet treatment after CABG surgery, 10-20% of vein grafts continue to occlude despite contemporary secondary preventative therapy. Compared to aspirin and other antiplatelet therapies like clopidogrel, ticagrelor treatment leads to a more pronounced platelet inhibition, and may substantially improve graft patency following CABG compared to aspirin. No data has yet to be collected regarding the impact of ticagrelor on saphenous vein graft patency following CABG. In this context, the investigators seek to compare vein graft patency between patients randomized to receive aspirin therapy, the current standard of care, or ticagrelor treatment, starting in the early postoperative period, and continuing for 2 years after CABG.

This clinical trial will be a randomized double-blind study focusing on ticagrelor antiplatelet therapy as a means of improving vein graft patency after CABG. Patients will be eligible if they have received at least 1 vein bypass graft at time of surgery. Patients will be randomized to receive either aspirin 81 mg bid or ticagrelor 90 mg bid. The aspirin and ticagrelor medications will be prepared in blinded capsules. Patients recovering from surgery will be eligible for study randomization within the first 5 postoperative days. Treatment will continue for 1 year, at which time patients will undergo a CT coronary angiogram to assess graft patency. Patients will then be invited to continue participating in the trial for 1 more year, and a repeat CT coronary angiogram will be performed at the 2 year postoperative time-point.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures
2. Female and/or male patients aged 18-90 years
3. Patients undergoing first-time CABG with at least 1 saphenous vein graft, irrespective of concurrent valve surgery

Exclusion Criteria:

1. Inability to provide informed consent
2. Pregnancy or seeking pregnancy
3. Patients undergoing redo-CABG
4. Serum creatinine \>1.8 mg/dL (need for contrast with CT coronary angiogram)
5. Hypersensitivity or allergy to aspirin or ticagrelor
6. Anticipated need for postoperative anticoagulation with coumadin, dabigatran or rivaroxaban (mechanical valve, chronic atrial fibrillation, DVT/PE)
7. History of gastrointestinal hemorrhage
8. Active pathological bleeding
9. History of intracranial hemorrhage
10. Severe hepatic impairment
11. Current or anticipated use of strong CYP3A4 inhibitors (e.g. ketoconazole, clarithromycin, nefazadone, ritonavir, and atazanavir)
Gastric Outlet Obstructions Tailored Covered Stents for GOO

gastric outlet obstruction tailored versus standard stents for malignant gastric outlet obstruction treatments

To determine the shape of the GOOs, stomach opacifications were performed using contrast media before stenting. In the GOO tailored group (33 cases), the distal stents were semi-spherical with a length of 20 mm and a diameter of 28 mm. The middle stent segments had diameters of 20 mm. The proximal ends of large cup-shaped stents had 53.3 ± 5.5 mm diameters and were 15 or 20 mm long, whereas the large funnel-shaped stents had 33.6 ± 3.6 mm diameters and were 25 or 30 mm long. The control group (32 cases) received standard uncovered stents (semi-spherical, with diameters of 28 mm and 20 mm long).Our hypothesis was that unresectable GOO tailored covered stents are superior to the standard uncovered ones in terms of stent re-obstruction and stent migration. In the current study the efficacy and safety of GOO tailored covered stents for the treatment of non-resectable GOOs caused by distal gastric cancer was compared with standard uncovered stents.

Eligibility Criteria:
Inclusion Criteria:

GOO defined by symptoms resulting in decreased oral intake (nausea, vomiting and inability to eat),the obstruction was caused by primary distal stomach cancer and the site of stenosis was between the gastric body and duodenum bulb

Exclusion Criteria:

the presence of only mild symptoms in patients who could tolerate a liquid diet, clinical evidence of perforation or peritonitis, evidence of multiple small-bowel obstructions because of peritoneal seeding as well as diabetes or other diseases that affect gastric motility and use of promotility agents.
SVF Therapy for Human Knee Osteoarthritis

The purpose of the study is to asses the safety and efficacy of SVF for treatment of knee osteoarthritis, and establish a novel method to provide 3D MRI imaging for human knee cartilage to qualitatively and quantitatively evaluate cartilage regeneration.

Study participants voluntarily provided written informed consent to participate in the study. The two knees of each patient were randomly assigned to autologous SVF treatment group or non-treatment control group. The patients were evaluated every 4 weeks for safety and efficacy of autologous SVF therapy for 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Knee Osteoarthritis
* Articular cartilage defect grades I/II of both knee

Exclusion Criteria:

* autoimmune or inflammatory arthritis
* serious medical disorders
Intense Monitoring Study on Tyvyt

The study is a multi-center, prospective, non-interventional and observational study, and will collect data on the safety and efficacy of Tyvyt® in the treatment of Chinese patients with relapsed or refractory classical Hodgkin's lymphoma.


Eligibility Criteria:
Inclusion Criteria:

Patients must be able to understand and voluntarily sign the informed consent form (ICF).

Patients must provide reliable contact information, including home phone numbers or follow-up phone number, and be voluntary to be followed up.

Patients must have agreed to use Tyvyt® to treat the target indication.

Exclusion Criteria:

Patients refuse to be included in the study or refuse to cooperate.

Patients have participated in another interventional studies within 4 weeks prior to enrollment.
Application of Al18F-octreotide PET/CT in Neuroendocrine Tumor

This is an open-label whole-body PET/CT study for investigating the value of Al18F-octreotide PET/CT in patients with Neuroendocrine Tumor

Octreotide is an artificial replacement for the natural growth hormone inhibitor in humans. It is a small peptide hormone consisting of 14 amino acids and is widely distributed in neuroendocrine cells, with the highest density in the brain, peripheral neurons, endocrine pancreas and gastrointestinal tract. Under pathological conditions, some tumour cells show overexpression of growth inhibitory receptors, such as endocrine tumours of the pancreas, pituitary adenomas, pheochromocytomas, paragangliomas, carcinoid tumours, medullary thyroid carcinomas, small cell lung carcinomas and other neuroendocrine tumours. Therefore, the sensitivity and specificity of octreotide imaging is high.

This study will provide a visual, reproducible and non-invasive imaging method for the diagnosis of neuroendocrine tumours through Al18F-octreotide PCT/CT imaging, providing an intuitive and clear imaging basis for clinical diagnosis, differential diagnosis and treatment, contributing to the development of medicine and science in the field of positron imaging.

Eligibility Criteria:
Inclusion Criteria:

* Patients with suspected or clearly diagnosed Neuroendocrine Tumor
* signed written consent.
* Willing and able to cooperate with all projects in this study.

Exclusion Criteria:

* pregnancy;
* breastfeeding;
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance.
Follow up of Thai Adult Volunteers With Breakthrough HIV Infection After Participation in a Preventive HIV Vaccine Trial

This protocol will study the clinical course of HIV-infection among volunteers who have received either a placebo injection or the experimental vaccine combination of ALVAC-HIV and AIDSVAX B/E prior to HIV-1 infection in reference to study NCT00223080 RV144. The study will assess whether those who received the experimental vaccine combination have a slower progression of HIV disease compared to those who received the placebo injection.

Prospective cohort study of the clinical course of HIV-1 infection occurring after candidate HIV-1 vaccination (breakthrough infection) with ALVAC-HIV (vcP1521) and AIDSVAX B/E in reference to study NCT00223080 RV144. This study will enroll volunteers who become HIV-infected during the course of follow up in a phase III preventive HIV vaccine trial conducted in Rayong and Chon Buri, Thailand. Volunteers will be enrolled in this protocol to provide additional long-term follow up to establish whether differences in viral load after infection (comparing vaccine to placebo) are associated with altered disease outcomes, as well as provide more detailed immunologic and virologic assessment of these volunteers.

After enrollment in RV152, follow-up visits were scheduled at 0, 1, 3, and 6 months, and every 3 months thereafter. After month 12, CD4+ T cell counts and viral load were obtained at 6-month intervals until the CD4+ T cell count declined to \<350/ul or highly-active antiretroviral therapy (HAART) was initiated, at which time CD4+ T cell counts and viral load were obtained every 3 months. Peripartum antiretroviral drugs given for prevention of mother-to-child-transmission was not considered a study endpoint, however HAART initiated during pregnancy and continued post-partum was counted. After a single CD4+ T-cell count \< 350/ul a second sample was requested about 2 weeks later, and if the confirmatory measurement was \>350/ul, a study endpoint was not registered and the volunteer resumed a normal visit schedule. A single genital fluid collection for viral load was obtained at the first RV152 visit. Clinical and laboratory data from RV144, including CD4+ T-cell and HIV-1 plasma viral load measurements, were linked to RV152 to inform primary and secondary protocol analyses as well as volunteer care and treatment.

Eligibility Criteria:
Inclusion Criteria:

* All individuals who become HIV-infected after receiving experimental vaccine or placebo in the RV144 clinical trial if they received at least one injection.
* The volunteer must give written, informed consent.

Exclusion Criteria:

* Persons who have a medical or psychiatric disorder, that in the judgment of the investigator(s), would interfere with or serve as a contraindication to adherence to the study protocol or ability to give informed consent.
* Persons who become HIV-infected after the completion of the RV144 protocol.
MiSaver® Stem Cell Treatment for Heart Attack (Acute Myocardial Infarction)

The objective of the present study is to establish the safety and efficacy of MiSaver® Stem Cell Treatment After a Heart Attack (Acute Myocardial Infarction)


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20\~80
* Acute Myocardial Infarction 1 to 10 days
* Cardiac enzyme CK-MB or Troponin \> 2X of high-end normal value
* ST-elevation on EKG (STEMI)
* Presence of regional wall motion abnormality
* Left ventricular ejection fraction (LVEF) of ≤40%
* Hemodynamically stable past 24 hour
* Participants with adequate pulmonary function
* Peripheral artery oxygen saturation ≥97%
* Karnofsky performance status scores of ≥60.

Exclusion Criteria:

* Age \<20 or \>80
* Pregnant or breast feeding
* Positive adventitious infections (such as HIV, hepatitis )
* Revascularization via coronary artery bypass surgery is required
* Coronary revascularization procedures is anticipated during the 6-month study period
* Severe aortic or mitral valve narrowing
* Evidence of life-threatening arrhythmia on baseline electrocardiogram (ECG)
* Short of breath unable to receive PCI examination or treatment
* Malignant tumor
* Hematopoietic dysplasia
* Severe organ disease
* With less than 1 year of life expectancy
* Chronic kidney disease with CCr\<20ml/min
* Kidney disease on renal dialysis
Efficacy of Adding LLL Therapy to Postural Correction Exercises on Postnatal SIJ Pain

the purpose of the study will be to to examine the effect of low level laser therapy on pain and function disability in postnatal women with sacroiliac joint pain.

Women are more susceptible to sacroiliac joint pain than men because the physiological changes associated with childbearing (e.g. pregnancy associated with weight gain, exaggerated lumber lordosis, hormone-induced ligamentous laxity and the mechanical trauma associated with childbirth) may result in sacroiliac joint pathology .

Low level laser is effective for treatment of various musculoskeletal pain disorders. It releases local neurotransmitters such as serotonin and endorphins. Additionally, the analgesic effect of LLLT is thought to be related to its anti-inflammatory action. Laser irradiations also relieve pain by alleviating and removing swelling and by increasing oxygenation of the tissues, thus results in reduction of the pain .

Eligibility Criteria:
Inclusion Criteria:

* Post natal women suffering from sacroiliac joint pain for at least 3 months.
* They should have moderate to severe pain in the sacroiliac joint region (visual analogue scale ≥ 4).
* They should have positive findings in at least three of five provocation sacroiliac joint tests (i.e., Patrick's sign, Gaenslen test, compression test, thigh thrust test and distraction test).
* Their age will range from 25 to 40 years old.
* Their Body mass index (BMI) will be ranged from 25 to 30 Kg /m2.
* They should not have any musculoskeletal disorders.

Exclusion Criteria:

* Lumber or hip joint pathology.
* Acute pelvic bacterial or viral infections or tumour.
* Taking nonsteroidal anti-inflammatory drugs, or hormonal treatments.
* Having positive straight leg raising test.
Use of Radiographic Contrast to Detect Dental Caries

The proposed test is intended to enable dentists to differentiate between cavitated and non-cavitated tooth decay in the areas where teeth are in contact (interproximal surfaces). In these areas, dentists cannot visually inspect for caries, and currently bitewing X-rays (BWs) only correctly detect the presence of enamel decay 15-25% of the time. This low sensitivity can lead to late treatment resulting in unnecessarily large fillings, crowns, pain, root canals, and possible later loss of teeth.

Hypothesis: Use of radiographic contrast on teeth will increase the accuracy of detection of early cavitation from 58% to 90%.

Tooth sites will be recorded by tooth number, type of surface (mesial, distal,occlusal), cavitated, non-cavitated, healthy. Radiographs will similarly be scored.Although contrast agents are classified as drugs this is not a study of drug properties or effect on cells since the properties of the agent are already well know and its safety record well established. This study will be recording the radiopacity of the contrast agent on healthy tooth surfaces, non-cavitated tooth surfaces and cavitated tooth surfaces. The outcome for each surface type will be presence or absence of a radiopacity on a radiograph which will be made at the one and only visit for each study subject. The radiograph contains the data from the intervention (placement of contrast agent) and the outcome will be assessed some weeks later after the completion of the data collection.

Eligibility Criteria:
Inclusion Criteria:

* must have a minimum of 2 adjacent teeth so that interproximal surfaces of interest are in contact and hidden from direct visual inspection.
* the occlusal plane should be normal so that the interproximal contact regions are normal.
* English or Spanish speaker.

Exclusion Criteria:

* pregnant women
* a person who has participated in a similar study involving dental radiography within the last 12 months.
* fillings must not be present in the regions of interest.