cyrilzakka/clinical-trials huggingface dataset:
REST Study: Left Ventricular Regression European Study

The purpose of this study is to obtain data regarding the left ventricular mass (LVM) regression 6 months after the implant of an SJM Epic™ and SJM Epic™ Supra valve by comparing LVM regression measured with magnetic resonance imaging (MRI) to LVM regression measured with echocardiography (2-dimensional \[2D\] mandatory; 3-dimensional \[3D\] in sites where the technology is available).


Eligibility Criteria:
Inclusion Criteria:

* Patient requires, for the first time, isolated aortic valve replacement due to aortic stenosis or mixed aortic stenosis disease etiology when aortic stenosis is predominant and aortic regurgitation is mild.
* Patient is of legal age in the host country.
* Patient (or legal guardian) has signed a study specific informed consent form

Exclusion Criteria:

* Patient was previously operated on with any heart surgery including heart valve replacement or coronary artery bypass graft (CABG); or underwent any form of myocardial revascularization in the past (including stents), etc.
* Patient requires any concomitant heart surgery other than the isolated native aortic heart valve replacement and concomitant ascending aortic replacement (e.g not allowed are: multiple valve replacements or concomitant CABG, pacemaker insertions, or severe septal hypertrophy needing surgical excision, etc.)
* Patient has unstable angina
* Patient is in New York Heart Association functional class IV
* Patient has significant abnormality in wall motion
* Patient is affected by active endocarditis.
* Patient has a cardiac pacemaker or automatic implanted cardiac defibrillator
* Patient is affected by acute aortic dissection.
* Patient is in chronic and persistent atrial fibrillation
* Patient receives hemodialysis therapy
* Patient has a medical condition which contraindicates implantation of the SJM Epic and Epic™ Supra Porcine Bioprosthetic Heart Valve (e.g. renal failure or abnormal calcium metabolism).
* Patient has aneurysmal clips or carotid artery vascular stents
* Patient has a neurostimulator
* Patient has an implanted or external drug infusion device (e.g. insulin pump)
* Patient has a bone growth/fusion stimulator
* Patient has a cochlear, otologic, or ear implant
* Patients with severe claustrophobia in which medical sedation is contraindicated or unable to resolve anxiety sufficiently
* Patients with ocular foreign body (e.g. metal shavings)
* Patient is pregnant or nursing
Sequential Immunization With Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine in Health Adults Based on 3 Doses Inactivated COVID-19 Vaccine

COVID-19 is a novel coronavirus infection caused by respiratory droplets and contact transmission. With the spread of the epidemic, it has become a serious threat to global public health. China has launched a full range of vaccination including the third dose of homologous and sequential booster immunization. To further improve COVID-19 vaccine immunization strategy, we start the clinic research about sequential Immunization With Recombinant Adenovirus Type-5-vectored COVID-19 Vaccine in Health Adults Based on 3 Doses Inactivated COVID-19 Vaccine in Zhejiang province.


Eligibility Criteria:
Inclusion Criteria:

1. Volunteers aged 18 and above at the time of screening;
2. Obtain the informed consent of the volunteers and sign the informed consent;
3. Volunteers are able and willing to comply with the requirements of the clinical trial protocol and complete the 6-month study follow-up;
4. Have received 3 doses of Sinovac/Beijing Biological Novel Coronavirus inactivated vaccine with an interval of 6-9 months.

Exclusion Criteria:

1. Patients with history or family history of convulsion, epilepsy, encephalopathy and mental illness;
2. Those who are allergic to any of the components of the study vaccine, have had a severe allergic reaction to the vaccine in the past, a history of allergy or asthma;
3. Serious adverse events related to vaccination occurred after previous vaccination; 4) Positive urine pregnancy test in women during lactation or childbearing age;

5) Acute febrile disease, infectious disease, SARS history; 6) Axillary body temperature \> 37.0℃; 7) Suffering from serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and uncontrolled medication (systolic blood pressure ≥180mmHg and/or diastolic blood pressure ≥110mmHg when measured on site); 8) Patients with serious chronic diseases that are in the advanced stage and cannot be controlled smoothly, such as diabetes and thyroid diseases; 9) Congenital or acquired angioedema/neuroedema; 10) Urticaria 1 year before receiving the test vaccine; 11) No spleen or functional no spleen; 12) Patients with chronic obstructive pulmonary disease, pulmonary fibrosis and other pulmonary abnormalities; 13) History of novel coronavirus infection/illness; 14) Have traveled to medium or high risk areas or left the country in the past 21 days; have a history of novel Coronavirus 2019-epidemiological contact; 15) The researcher made a judgment based on various medical, psychological, social or other conditions that might be contrary to the test protocol or affect the subjects to sign informed consent.
Study of Diclofenac Capsules to Treat Pain Following Bunionectomy

The purpose of this study is to determine whether Diclofenac \[Test\] Capsules are safe and effective for the treatment of bunionectomy pain.


Eligibility Criteria:
Inclusion Criteria:

* Patient is male or female between 18 and 65 years of age
* For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
* Has undergone primary, unilateral, first metatarsal bunionectomy with no additional collateral procedures
* Patient must be willing to stay at the study site ≥ 72 hours

Exclusion Criteria:

* Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
* Patient has a current disease or history of a disease that will impact the study or the patient's well-being
* Patient has used or intends to use any of the medications that are prohibited by the protocol
* Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
* Patient has taken another investigational drug within 30 days prior to screening
Safety of Lung Cryobiopsy in People With Cancer

The purpose of this study is to find out whether a biopsy technique called transbronchial cryobiopsy (TBCB) is a safe alternative to the standard biopsy procedure (transbronchial forceps biopsy; TBFB). The study researchers think that TBCB may provide better biopsy samples to help diagnose lung disease.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or greater
* Patients with known or suspected diagnosis of cancer and indeterminant pulmonary nodules or diffuse parenchymal lung disease with non-diagnostic clinical profiles for whom a lung biopsy is deemed useful for diagnosis.

Exclusion Criteria:

* Patients with pulse oximetry less than 92% on oxygen delivery up to 2 L nasal cannula.
* Uncorrectable coagulopathy defined as:

  * Platelet count \<50,000 x 10\^9/L or
  * prothrombin time international normalized ratio \>1.5
* Known pulmonary hypertension or echocardiographic pulmonary artery systolic pressure \>50mmHg
* A secure diagnosis based on clinical and high-resolution CT scan data.
* Antiplatelet therapy that cannot be held for more than 5 days.
* Any patient deemed unfit to undergo bronchoscopy by the proceduralist
* Female patients with a positive pregnancy test within 30 days of the planned study procedure
Evaluating the Role of Inflammation in Neonatal Epileptogenesis

The purpose of this study evaluate the relationship between inflammation and epilepsy in neonates with seizures after birth.

Seizures are a common symptom of neurologic dysfunction in the neonatal period, affecting more than 16,000 newborns in the United States per year. Over 25% of neonates with acute symptomatic seizures develop post- neonatal epilepsy (PNE), which is often resistant to medical therapies. There is a critical need to identify those patients most at risk for PNE and understand the mechanisms by which early seizures increase the propensity for recurrent seizures, in hopes of identifying novel therapeutic targets in this population. There is increasing evidence for the role of neuro-inflammation in the development of epilepsy. Levels of cytokines and micro-RNA (miRNA) may serve as markers of disease severity and have been implicated in epileptogenesis in animal models. The purpose of this study is to evaluate plasma cytokine and miRNA levels after neonatal-onset acute symptomatic seizures and determine their association with acute seizure severity and PNE.

Eligibility Criteria:
For participants in the acute symptomatic seizure group:

Inclusion Criteria:

* Neonates \<44 weeks corrected age at seizure onset
* Seizures due to acute brain injury
* Parent(s) who are English or Spanish literate (with assistance of interpreter)

Exclusion Criteria:

* Neonates at risk for adverse outcome independent of seizures and underlying brain injury
* Neonates with mild, temporary causes for seizures
* Newborns with neonatal-onset epilepsy syndromes
* Neonates who do not survive the initial hospital admission
* Neonates will not be excluded based on race, ethnicity, gender or gestational age

For participants in the control group:

Inclusion Criteria:

* Neonates that are born \> 37 weeks and \<44 weeks postmenstrual age at enrollment
* Consultation by the pediatric neurology inpatient service due neonatal paroxysmal events, with normal neurologic examination and ultimate diagnosis of non-epileptic spells on continuous video-EEG (ordered for clinical purposes, not for research) OR consultation for hypoxic ischemic encephalopathy in neonates undergoing therapeutic hypothermia, with early exit from therapy owing to normal neurologic examination, normal continuous video-EEG and uncertain diagnosis of encephalopathy.
* Neonates requiring neurologic consultation for mild hypoxic-ischemic encephalopathy (HIE) undergoing therapeutic hypothermia, with normal examination, cEEG, and neuroimaging upon rewarming.
Routine Preoperative Antibiotic Prophylaxis in Modified Radical Mastectomy

This is a randomized, double blinded, placebo-controlled trial on the routine use of preoperative antibiotic prophylaxis in modified radical mastectomy to evaluate the efficacy of preoperative prophylactic antibiotics in the prevention of surgical site infection (SSI) in patients undergoing modified radical mastectomy (MRM) for breast care.

A randomized, double blinded, placebo-controlled trial on the routine use of preoperative antibiotic prophylaxis in modified radical mastectomy to evaluate the efficacy of preoperative prophylactic antibiotics in the prevention of surgical site infection (SSI) in patients undergoing modified radical mastectomy (MRM) for breast care.

Women with breast cancer who will undergo elective MRM were recruited for the study. Excluded were patients with significant co-morbid factors, for simultaneous breast reconstruction or bilateral oophorectomy, with intake of antibiotics within one week, with known allergy to cephalosporins, and those with local infection. Patients were randomized to receive either transvenous cefazolin 1 gram or sterile water only within 30 minutes prior to skin incision. Standard skin preparation and operative technique for MRM were carried out. Wounds were assessed for the presence of SSI and other complications weekly for 30 days.

Eligibility Criteria:
Inclusion Criteria:

* Women with histologically diagnosed breast cancer of age group 18-80 years old, ECOG 0-1, clinical stage I to IIIB, admitted to the surgery ward, who were scheduled for elective MRM.

Exclusion Criteria:

* Women with significant co-morbid factors (diabetes mellitus, severe malnutrition, corticosteroid therapy), those scheduled for simultaneous breast reconstruction or bilateral oophorectomy, with intake of antibiotics within one week prior to surgery, with known allergy to cephalosporins, and those with local infection.
Effectiveness of Enhanced Treatments for Drug Dependence

The purpose of this challenge grant is to conduct an initial test of a new, enhanced version of this protocol (telephone monitoring and counseling - enhanced, or TMAC-E), which has been modified to include the elements of our existing continuing care intervention plus patient-centered changes to boost patient involvement and community linkages. The investigators will recruit 150 cocaine dependent patients in publicly funded, community-based programs and randomize them to treatment as usual or the TMAC-E and follow them for 12 months.


Eligibility Criteria:
Inclusion Criteria:

* (1) qualify for a DSM-IV diagnosis of cocaine dependence, with some cocaine use in the prior 6 months;
* (2) be 18 to 75 years of age;
* (3) have no current psychotic disorder or evidence of dementia severe enough to prevent participation in outpatient treatment;
* (4) have no acute medical problem requiring immediate inpatient treatment;
* (5) not be in methadone or other modes of Drug and Alcohol treatment, other than Intensive Outpatient Program;
* (6) be willing to be randomized and participate in research;
* (7) because of study follow-up requirements, subjects will be able to provide the name, verified telephone number, and address of at least one contact who can provide locator information on the patient during follow-up. We will include patients with dependence on other substances, provided that they are cocaine dependent and meet other inclusion criteria.

Exclusion Criteria:

* have a current psychotic disorder or evidence of dementia severe enough to prevent participation in outpatient treatment;
* have acute medical problem requiring immediate inpatient treatment;
* are in methadone or other modes of DA treatment, other than IOP;
* or cannot provide names of people who can get messages to them for follow up, in the event we cannot locate the participant at their original address and number. Also, if they are court mandated to treatment or otherwise considered a prisoner, they will be ineligible for the study as we have not applied for Subpart C approval.
Learning Skills in Young Specialists and Residents in Operative Vaginal Delivery Using Simulator Models

Evaluation of different learning programs on persistence of skills in operative vaginal delivery

Investigators enrolled residents and young specialist randomly exposed to simulation of operative vaginal delivery or a lecture before and after experience on simulator program. The two groups were exposed after 8-12 weeks to a second experience of simulator program due to evaluate the improve, deterioration of skills in operative vaginal delivery.

12-months persistence of skills were evaluated

Eligibility Criteria:
Inclusion Criteria: residents or young specialists (less than 5 years after ending of residency) -

Exclusion Criteria: medical students before MD

-
Study Evaluating the Utility of 18F-FDG PET in Assessing Early Response to Neoadjuvant Chemotherapy in Patients With Mammary Gland Cancer

Neoadjuvant chemotherapy is frequently proposed to patients with mammary gland cancer. The aim is to reduce tumor volume before surgical therapy. Obtaining a pathologic Complete Response (pCR) is regarded as a good prognostic factor with less risk of recurrence. The rate of pCR is about 20%, although there are important variations according to tumor subtype and the type of treatment. The objective of the new therapeutic strategies is to increase this response rate.

The purpose of this study is to investigate the possibility of early evaluation of neoadjuvant chemotherapy response after one cycle of neoadjuvant chemotherapy by positron emission tomography (PET) with (18) F-fluorodeoxyglucose (FDG) in patients.


Eligibility Criteria:
Inclusion Criteria:

* patient having been informed of the study
* patient affiliated to a social health insurance
* ≥ 18 years
* patient presenting a breast cancer histologically confirmed
* indication of neoadjuvant chemotherapy treatment (classification UICC: II or III)
* patient agrees with exploitation of his clinical, biological and image data

Exclusion Criteria:

* distant metastasis
* contraindications to chemotherapy
* contraindications to surgery
* refusal
* serious illness not balanced, subjacent infection
* pregnancy or breast feeding
* diabetes not controlled (glycemia\> 8 mmol/L)
* psychiatric disease
* patient under supervision, trusteeship or safeguard of justice
A Health Economic Trial in Adult Patients Undergoing Ileostomy Reversal MA402S23B501

This study is designed to compare the standard of care against EXPAREL (bupivacaine liposome injectable suspension) to determine if total opioid consumption is reduced when using EXPAREL, therefore possibly reducing total hospitalization costs.

This is a phase 4, prospective, sequential, open-label study designed to evaluate the efficacy, safety, and health economic benefits of intraoperative local wound infiltration with EXPAREL (bupivacaine liposome injectable suspension) compared with postsurgical administration of standardized intravenous (IV) morphine sulfate or Sponsor-approved equivalent for postsurgical analgesia in adult patients undergoing ileostomy reversal with general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years of age or older.
* Patients scheduled to undergo ileostomy reversal.
* Ability to provide informed consent, adhere to study visit schedule, and complete all assessments.

Exclusion Criteria:

* Patients with a history of hypersensitivity or idiosyncratic reactions or intolerance to any local anesthetic, opioid, or propofol.
* Patients who abuse alcohol or other drug substance.
* Patients with severe hepatic impairment.
* Patients currently pregnant or who may become pregnant during the course of the study or who are unwilling to use acceptable means of contraception for at least one month before and one month after dosing.
* Patients with any psychiatric, psychological, or other condition that the Investigator feels may make the patient an inappropriate candidate for this clinical study.
* Patients who have participated in an EXPAREL study within the last 30 days.
* Patients who have received an investigational drug within 30 days prior to study drug administration, or planned administration of another investigational product or procedure during the patient's participation in this study.

In addition, the patient will be ineligible if he/she meets the following criteria during surgery:

* Patients who have any concurrent surgical procedure.
* Patients who receive intraoperative administration of opioids (other than fentanyl or analogs) or any other analgesic, local anesthetics, or anti-inflammatory agents.
* Patients who receive Entereg(R).
Thalamic Deep Brain Stimulation for Tourette Syndrome

In this single-center trial, we aim to include 8 patients with severe and medically refractory Tourette's syndrome. All patients undergo deep brain stimulation surgery with two electrodes located in the centromedian-parafascicular complex. Tic severity and secondary outcome measurements are assessed six and twelve months after surgery. Additionally, a short randomized, double-blinded sham controlled crossover sequence of 24 to 48 hours in either active or sham stimulation is implemented after both 6 and 12 months assesments. Subjects and clinicians are blinded to treatment allocation.


Eligibility Criteria:
Inclusion Criteria:

* Das Tourette-Syndrom (ICD-10: F 95.2; DSM IV: 307.23) als Hauptdiagnose. Bei dem Patienten ist aufgrund einer chronischen, schwergradigen und therapieresistenten Verlaufsform des TS eine Behandlung mittels THS thalamischer Strukturen im Sinne einer ultima ratio vorgesehen.
* Alter des Patienten 18 bis 65 Jahre
* Sicher im Verstehen der deutschen Sprache
* Unterzeichnete Einverständniserklärung

Exclusion Criteria:

* Klinisch manifeste Psychose
* Schwangerschaft und Stillzeit
* Unterbringung nach PsychKG
* Kontraindikationen einer MRT-Untersuchung wie z. B. implantierter Herzschrittmacher / Defibrillator
* Neoplastische neurologische Erkrankungen
* Kontraindikationen einer stereotaktischen Operation, wie z. B.: erhöhte Blutungsneigung, cerebrovaskuläre Erkrankungen (z. B. arteriovenöse Malformationen, Aneurysmata, systemische Gefäßerkrankungen, die auf das Cerebrum übergreifen).
* Teilnahme an einer anderen klinischen Studie
* Hirnassoziierte Kriterien, die eine OP ausschließen (Gefäßanomalien, große arteriovenöse Malformationen, Hirnmetastasen, Neoplasien des ZNS (Ausnahme asymptomatisches inzidentielles Meningeom))
* Antikoagulationtherapie, die in der perioperativen Phase nicht ausgesetzt werden kann
* OP am Gehirn in der Anamnese, die mit der Platzierung/Funktion des MP interferieren
* Med. Gegebenheiten, die mit der Studienprozedur interferieren oder Evaluation der Studienparameter beeinträchtigen inkl. Erkrankungen im terminalen Stadium (Lebenserwartung \< 12 Monate)
* Akute Suizidalität
* Abhängigkeit von Alkohol oder Drogen (exklusive Cannabis, da es von schwer betroffenen Patienten teilweise zur Ticreduktion im Sinne einer Selbstmedikation eingesetzt wird sowie exklusive Opioide und Benzodiazepine, wenn diese initial zur Ticreduktion im Sinne einer Selbstmedikation eingesetzt wurden)
* Klinisch relevante internistische oder neurologische Erkrankungen
* Intelligenzminderung
* Alle aktiv implantierten Medizinprodukte
* Schweres Schädel-Hirn-Trauma in der Anamnese
* Metallimplantate im Kopfbereich ( Bsp. Aneurysmaclips)
Study for Pre-Surgical Weight Loss in Type II Diabetes Patients

The purpose of this study is to determine whether the GI Sleeve is safe and effective in treating Type II diabetes patients

Patients with obesity are at significantly greater risk of developing complications such as pulmonary dysfunction, diabetes, hypertension, and other co-morbid risks. NIH panel recommendations state that even a 10% short-weight loss would greatly reduce these risks. GI Dynamics' GI Sleeve represents a viable alternative to other short-term pre-surgical weight loss methods. GI Sleeve is a device that can be implanted and removed through minimal invasive endoscopic techniques. This endoscopic procedure brings potential benefits to patients in that it is minimally invasive, efficacious, and allows patients to recover faster with less morbidity and mortality.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65
* BMI 40 to 60
* Type II Diabetes
* Candidates for bariatric surgery

Exclusion Criteria:

Patients with

* hepatitis B or C
* gastroesophageal reflux disease (GERD)
* HIV Positive diagnosis
* pancreatitis
* conditions of gastrointestinal tract, such as ulcers or Crohn's
* an infection or who are H. Pylori positive