cyrilzakka/clinical-trials huggingface dataset:
Prospective Comparative Study Evaluating the Early Complications of Robot-assisted Radical Prostatectomy Performed As an Outpatient Versus an Inpatient Procedure.

The goal of this clinical trial is to demonstrate that outpatient management for robotic-assisted radical prostatectomy is not inferior to inpatient management in terms of the occurrence of early post-operative complications.

Researchers will compare outpatient robot-assisted radical prostatectomy to inpatient procedure.

Participants will:

* Visit the clinic after the operation once at 45 days, 6 months and once a year for up to 5 years for check-ups and tests.
* Answer survey questions about urinary and erectil functions, stress and anxiety, satisfaction, quality of life for 6 months
* Keep a diary to record procedures and treatments related to the care provided


Eligibility Criteria:
Inclusion Criteria:

* Male, aged 18 and over
* Patient with prostate cancer for which the multidisciplinary meeting has proposed radical prostatectomy as a therapeutic option (with or without lymphadenectomy)
* Patient eligible for outpatient treatment :

  1. The patient undertakes to comply with all medical instructions given during surgical consultations and the anaesthetic consultation.
  2. The patient has access to personal transport allowing, if necessary, return to the facility or another approved facility (transport time and distance from the facility are not exclusion factors)
  3. The patient has access to telephone communication facilities.
  4. The patient undertakes not to drive a vehicle and to be accompanied on his return home and for the next 24 hours by a responsible person who will be familiar with the monitoring instructions.
  5. The patient plans to remain in hospital overnight if this is deemed necessary by the department's doctors (operator and anaesthetist). The patient accepts this mode of care and its constraints.
* Participant affiliated to or benefiting from a social security scheme
* The participant has been informed and has given his/her free, informed and written consent (at the latest on the day of inclusion and before any examination required by the research).

Exclusion Criteria:

* Patient already treated for prostatic carcinoma with brachytherapy, radiotherapy or focal therapy
* Patient participating in ongoing research or in a period of exclusion at the time of inclusion
* Refusal or inability to comply with the study protocol for any reason whatsoever
* Protected participant: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
Study of Alvimopan for the Management of Opioid-induced Postoperative Bowel Dysfunction/Postoperative Ileus

Patients undergoing major abdominal surgery are at highest risk for developing postoperative ileus (POI), occurring in nearly all cases. Signs and symptoms of POI may include abdominal distention, bloating, persistent abdominal pain; nausea and/or vomiting; delayed passage or inability to pass flatus or stool; and inability to tolerate a solid diet. This study will test the ability of alvimopan 6 mg or 12 mg given 2 hours before the scheduled start of surgery to hasten the recovery of GI function in patients undergoing major abdominal surgery (bowel resection or abdominal hysterectomy).

Postoperative ileus (POI) is temporary slowing down or stopping of bowel function and a slowing down of movement of contents of the intestines. This functional impairment persists for a variable duration following surgery, usually resolving within 1 day in the small intestine, 1 to 3 days in the stomach and 3 to 5 days in the colon. When POI persists for more than 5 days, it is generally considered severe, sometimes referred to as complicated or prolonged POI, and increases the risk for related morbidity. No drug therapy has been shown to consistently shorten the duration of POI. This study is designed to demonstrate that alvimopan, a novel, peripherally acting mu opioid receptor antagonist, accelerates the recovery of GI function in patients undergoing bowel resection of hysterectomy.

Eligibility Criteria:
Inclusion Criteria:

* Subject is scheduled for a partial small/large bowel resection of primary anastomosis or total abdominal hysterectomy (simple or radical) via laparotomy
* Subject is scheduled to receive primary postoperative pain management with intravenous (i.v.) patient-controlled analgesia (PCA) opioids

Exclusion Criteria:

* Subject is scheduled for a total colectomy, colostomy, ileostomy
* Subject has complete bowel obstruction
* Subject is currently taking opioid analgesics or has taken opioid analgesics within 4 weeks prior to surgery
BEAM COPD: Breathing, Education, Awareness and Movement in Chronic Obstructive Pulmonary Disease (COPD)

The main purpose of this study is to determine feasibility and effects of tai chi and mind-body breathing in patients with COPD.


Eligibility Criteria:
Inclusion Criteria:

1. Moderate-severe COPD
2. Age ≥ 40 years

Exclusion Criteria:

1. Subjects with respiratory failure or GOLD stage 4 who are unable to safely perform a 6 minute walk test or otherwise safely exercise as deemed by a physician.
2. COPD exacerbation requiring steroids, antibiotics, ED visit or hospitalization within the past 2 weeks unless physician deems subject at baseline
3. Planned major pulmonary intervention within the next 3 months
4. Hypoxemia on walk test or cardiopulmonary exercise test
5. Inability to ambulate due to vascular or other neuromuscular conditions that would preclude a walk test
6. Clinical signs of unstable cardiovascular disease
7. Severe cognitive dysfunction
8. Non-English speaking
9. Current active participation in pulmonary rehabilitation program or current regular practice of tai chi
10. Physician diagnosis of unstable/untreated clinical depression
11. History of lung cancer
Long-term Outcomes of Early-stage Nasopharyngeal Carcinoma Patients Treated with Radiotherapy Alone

Nasopharyngeal carcinoma (NPC) is a malignant tumor primarily originating in the nasopharynx, commonly found in populations in southern China, certain regions of Asia, and North Africa. The main treatment for NPC is primarily radiotherapy, with some patients receiving combined chemotherapy. Early-stage NPC patients can achieve adequate tumor control with radiation therapy alone. Various studies report that the 5-year survival rate for very early-stage NPC exceeds 90%. However, some stage I patients experience local recurrence or distant metastasis after treatment, indicating treatment failure. This study aims to retrospectively analyze the factors contributing to treatment failure and prognostic factors in this group of early-stage NPC patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with nasopharyngeal carcinoma based on endoscopic pathological reports.
* Included early-stage patients classified as cT1-2, cN0-1, M0.
* Had baseline imaging (CT or MRI) prior to treatment.
* Received definitive radiotherapy at our institution and had long-term follow-up with complete medical records.

Exclusion Criteria:

* Excluded from the study are patients with local lymph node metastasis or distant metastasis (cN ≥ 2, M = 1) as determined by imaging studies.
* Patients who did not receive definitive radiotherapy at our institution or had incomplete medical records during long-term follow-up are also excluded.
* Patients diagnosed with any other primary cancer within five years prior to the diagnosis of nasopharyngeal carcinoma (excluding DCIS and skin cancer) are excluded from the study.
Low Von Willebrand in Ireland Cohort Study

The Low Von Willebrand in Ireland Cohort (LoVIC) study focuses on the bleeding phenotype and biological mechanisms underlying low Von Willebrand Factor (VWF) levels.

All patients with bleeding disorders in Ireland are registered on a national bleeding disorder database and attend the National Coagulation Centre in St. James's Hospital, Dublin, Ireland or the paediatric centre, Our Lady's Children's Hospital Crumlin for annual review. At review eligible patients will be invited to participate in the Low Von Willebrand in Ireland Cohort (LOVIC) study.

Following consent, an extensive bleeding assessment tool will be administered by a coagulation haematologist to all participants from which the International Society of Thrombosis and Haemostasis Bleeding Assessment Tool (ISTH BAT) and the Condensed Molecular and Clinical Markers for the Diagnosis and Management of Type 1 Von Willebrands Disease (MCMDM-1 VWD) scores can be derived. In addition, blood will be drawn for von Willebrand factor (VWF) measurements, VWF propeptide, platelet VWF. Citrated plasma and DNA will be stored for each patient. The relationship between laboratory parameters, (including von Willebrand factor, platelet VWF, FVIII and concomitant coagulation disorders) and the clinical phenotype in patients with low VWF will be studied. We will assess the effect of the laboratory parameters on the severity of bleeding tendency. In the future mutation analysis of the VWF gene will be performed in all participants in the LOVIC study.

Historical patient records and laboratory results will be reviewed and DDAVP (1-desamino-8-D-arginine vasopressin) fall off studies documented where available. If no previous DDAVP fall off study has been performed patients will be invited to attend.

Eligibility Criteria:
Inclusion Criteria:

* Two lowest VWF levels (VWF Antigen and/or VWF Ristocetin cofactor activity and/or VWF Collagen Binding) \>30 IU/dL \<50 IU/dL.

Exclusion Criteria:

* Pregnant patients
* Hospitalised patients/acutely unwell patients
Oseltamivir Infant Influenza Safety Study

In June 2009, the World Health Organization (WHO) declared a global pandemic of influenza A (H1N1). Although little is known about the pandemic influenza strain in children, during previous pandemics and influenza seasons children less than one year of age were shown to be at higher risk of influenza complications than older children. In light of the 2009 H1N1 pandemic situation, the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Health Canada issued emergency authorizations for oseltamivir to be used to treat and prevent influenza in infants under 1 year of age. It is anticipated that oseltamivir use in infants will dramatically increase due to the new authorizations for use in this population and high prevalence of H1N1 influenza circulating in the population. Ongoing safety surveillance is critical and this study will provide further data for evaluating the risk/benefit ratio of prescribing oseltamivir to this population in the current milieu of both seasonal and pandemic influenza viruses circulating in the population. The study will also provide useful information on the dose and duration of treatment used in clinical practice and their relationship to adverse events.

This study is a prospective, observational, multicenter short-term safety study of the use of oseltamivir (prophylaxis or treatment) in children 24 months of age or younger. An internal comparator group of children diagnosed with influenza and not treated with antiviral medications will be enrolled. The study includes a 30-day follow-up period and will be conducted in multiple sites in multiple countries within the European Union. The study will cover two consecutive influenza seasons: 01 October 2009 - 31 May 2010 and 01 October 2010 - 31 May 2011. Data collection may be interrupted in the interim period between influenza seasons (June 1, 2010 - September 30, 2010), depending on whether the influenza season follows the expected cycle.

Eligibility Criteria:
Inclusion Criteria:

* 24 months of age or younger at time of enrollment
* Diagnosis of influenza A or B (suspected\* or confirmed by viral testing) either treated with oseltamivir or with no antivirals OR prescribed oseltamivir for post-exposure influenza prophylaxis
* Parent/legal guardian willing to provide informed consent and be contacted by telephone as part of follow-up

Exclusion Criteria:

* Patients will be excluded if treated with an influenza antiviral other than oseltamivir, including amantadine, rimantadine, or zanamivir.

  * Suspected influenza is defined as an acute febrile illness characterized by the presence of fever and 1 or more of the following symptoms: cough, coryza/nasal congestion or sore throat.
Securing the Immediate Perioperative Walk: Creating and Validating a Score.

The aim of this study is to set up a pre and postoperative ambulation score on a population of adult patients and undergoing outpatient surgery operated under locoregional anesthesia and sedation.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years-old
* Patient undergoing sedation with or without associated local anesthesia
* Patient having giver their consent
* Patient are benefiting from a social protection insurance
* Patient hospitalized as part of the outpatient for ophthalmologic surgery or upper limb surgery, plastic surgery or surgery for implantation of a vascular access device

Exclusion Criteria:

* Patient whose surgery is performed on the lower limbs
* Patient with psychiatric disorders
* Patient with dementia
* Patient who has already participated in this same study (ex: cataract the second eye is made a few weeks after the first)
* Patient's refusal to participate in the study
* Protected patients: Adults under guardianship, curatorship or other legal protection, deprived of their liberty by judicial or administrative decision; Pregnant, breastfeeding or parturient woman; Hospitalized without consent.
Erythromycin Versus Gastric Lavage to Improve Quality of Endoscopy in Patients With Upper Gastrointestinal Bleeding

The researchers will investigate whether erythromycin infusion is better than gastric lavage prior to emergency endoscopy to improve the quality of examination in patients with upper gastrointestinal bleeding.

The researchers will investigate whether erythromycin infusion is better than gastric lavage prior to emergency endoscopy to improve the quality of examination in patients with upper gastrointestinal bleeding.

One hundred and twenty-two patients admitted within 12 hours after hematemesis will be randomly assigned to receive erythromycin infusion or gastric lavage by nasogastric tube prior to emergency endoscopy. The endoscopic procedures will be recorded on Digital Video Disc (DVD). Two endoscopists blinded to the cleansing strategy will assess the quality of examination of the upper gastrointestinal tract by using scales designed by Frossard and Avgerinos .

Secondary endpoints will be the need for a second-look endoscopy, the mean number of blood units transfused, the need of surgery or arteriography, and the mean duration of hospitalization

Eligibility Criteria:
Inclusion Criteria:

* recent hematemesis (\<12 hours)

Exclusion Criteria:

* macrolides allergy
* pregnancy or lactation
* treatment with terfenadine, astemizole or cyclosporine
* prior gastrectomy
El Paso Public Health Biorepository

The prevalence of tooth decay and other oral diseases are overlooked indicators of overall public health. To improve the understanding of oral health in El Paso, the City of El Paso Health Department will work with Texas Tech University Health Sciences Center at El Paso to determine factors that contribute to poor oral health, and lead to cavities and periodontitis. The team will collect saliva from children and young adults to study oral infections, markers of inflammation, and other contributors to oral illnesses in Mexican-American individuals.

As per summary above.

Eligibility Criteria:
Inclusion Criteria:

* Individuals seen at the City of El Paso dental or pediatric clinics ages 10-21
* Healthy children and patients that are likely to be seen in the clinics within the predetermined follow-up time of 6 months

Exclusion Criteria:

* Patients under 10 years of age and over 21 years of age.
Stool Transplant to Control Treatment-related Diarrhea

This study will test the safety, effectiveness, and feasibility of a treatment called fecal microbiota transplantation (FMT) to reduce the symptoms of ICI-related diarrhea.

FMT uses a liquid preparation of stool collected from a healthy donor with normal (healthy) bacteria; this liquid is infused into the small or large intestine of a recipient during a colonoscopy procedure. The study researchers think that the healthy bacteria in the transplanted stool will grow and replace the unhealthy bacteria and return the intestines and colon of the recipient to a healthy state.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Patient has been treated with immune checkpoint inhibitors (ICI), including anti-CTLA-4, anti-PD-1 and anti-PDL-1 therapy for any malignant indication
* Patient has developed diarrhea ≥ Grade 2 attributed to ICI
* Patient has diarrhea ≥ Grade 2 attributed to ICI, that persists despite treatment with corticosteroids for at least 72 hours and/or at least one dose of a biologic medication, such as infliximab or vedolizumab, with symptoms that persist or recur at least 72 hours post-infusion ° If no to the above, patient has a contraindictation to immunosuppressive treatment

Exclusion Criteria:

* Active GI infection, including untreated viral, bacterial or fungal or alternative identified cause(s) of diarrhea.
* Antibiotic exposure within 48 hours prior to FMT
* Expected prolonged compromised immunity indicated by at least one of the below:

  * Known HIV infection with CD4 count \<240
  * ANC \<1000/mm3 (use of growth factors to raise ANC is acceptable)
* Seronegative for EBV or CMV (i.e. EBV IgG negative or CMV IgG negative)
* Contraindications to anesthesia for procedure indicated by at least one of the below:

  * Serious cardiopulmonary comorbidities
  * Inability to tolerate anesthesia
* Pregnancy

  * Patient is pregnant
  * Women of childbearing potential should not have plans to became pregnant or breastfeed an infant and must agree to use a highly effective method of birth control until 2 months after treatment with FMT (e.g. barrier method, oral or parenteral contraceptives, a vasectomized partner, or abstinence from sexual intercourse)
* Severe food allergies
Efficacy and Safety of AL-4943A Ophthalmic Solution in Patients With Allergic Conjunctivitis Using the Conjunctival Allergen Challenge (CAC) Model

The purpose of this study was to assess the safety and efficacy of AL-4943A ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis using the Conjunctival Allergen Challenge (CAC) model.

This study consisted of 5 Visits. Eligible patients underwent allergy testing using the Conjunctival Allergen Challenge (CAC) model, which reproduces the signs and symptoms of Seasonal Allergic Conjunctivitis by replicating the natural disease process. Patients demonstrating a positive reaction to the CAC at Visit 1 (screening) and Visit 2 (confirmatory) were randomized to treatment at Visit 3 (Day 0). The test article was instilled at Visit 3, with treatment efficacy CAC performed at 24 hours duration of action. The test article was instilled again at Visit 4 (Day 14), with treatment efficacy CAC performed at 16 hours duration of action. The test article was instilled a final time at Visit 5 (Day 21), with treatment efficacy performed at onset of action.

Eligibility Criteria:
Inclusion Criteria:

* Able to be dosed in both eyes, able and willing to make the required study visits and to follow instructions.
* Diagnostic skin test indicative of allergy for cat hair, cat dander, grasses, ragweed, dust mite, dog dander, cockroach and/or trees within 24 months of Visit 1.
* History of seasonal or perennial allergic conjunctivitis for at least 1 year prior to Visit 1.
* Positive bilateral CAC response at Visit 1 and Visit 2.
* Willing to discontinue contact lens wear for at least 72 hours prior to Visit 1 and throughout the study.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Known history or presence of persistent dry eye syndrome, or currently requiring frequent use (\> 4 days per week) of artificial tears, gels or lubricants, presence of punctal plugs, use of Restasis®, or topical ocular corticosteroids for dryness of eyes.
* Presence of active blepharitis, active meibomian gland dysfunction, active rosacea affecting the ocular adnexa, follicular conjunctivitis, iritis, preauricular lymphadenopathy, ocular irritation not due to ocular allergy, or any other clinically significant ophthalmic abnormality that may affect the study outcomes.
* Presumed or actual ocular infection (bacterial, viral or fungal) or history of ocular herpes in either eye as determined by patient history and/or examination within 30 days of Visit 1.
* Presence of any chronic ocular degenerative condition or active intra-ocular inflammation in either eye that in the opinion of the Investigator is likely to advance/worsen during the time course of the study.
* Any contraindications or hypersensitivities to the use of the study medication or their components.
* Other protocol-defined exclusion criteria may apply.
Buprenorphine Maintenance for Opiate Dependence - 6

The purpose of this study is to determine the efficacy of buprenorphine as a substitution pharmacotherapy for opiate dependence.


Eligibility Criteria:
Please contact site for information.
A Phase II Study of Icotinib in Treating Patients With Advanced Nasopharyngeal Carcinoma

This is a phase 2 study to evaluate the efficacy of single-agent icotinib in patients with advanced nasopharyngeal carcinoma.

This phase 2 study is aimed to evaluate the efficacy of single-agent icotinib in patients with pretreated, advanced nasopharyngeal carcinoma. The primary endpoint is disease control rate (DCR).

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed advanced NPC
* Patients must be platinum-resistant defined as recurrence or progression of disease \<6 months since previous treatment with a platinum based treatment regimen.
* Measurable disease per RECIST
* Adequate organ and marrow function
* Capable of understanding and complying with the protocol, and written informed consent

Exclusion Criteria:

* Prior treatment with gefitinib, erlotinib, or other drugs that target EGFR
* Patients must not be receiving any other investigational agents
* Other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), or active uncontrolled infection
* Women who are pregnant or breast-feeding