cyrilzakka/clinical-trials huggingface dataset:
Weight Loss Following Gastric Bypass or Sleeve Surgery

The overall aim is to study the multiple factors determining the variation of weight loss after Roux-en-Y Gastric Bypass (RYGB) and Sleeve surgery.

The specific aims are to evaluate:

a) what explains the large individual differences in weight loss seen after RYGB and Sleeve surgery, b) if it is possible pre-operatively to identify which patients will not obtain beneficial effects of bariatric surgery in relation to weight loss and quality of life and c) if patients in need of improved care can be identified pre- and/or early post-operatively.


Eligibility Criteria:
Inclusion Criteria:

* All patients approved for bariatric surgery at Bariatric Clinic, Køge Hospital, Denmark

Exclusion Criteria:

* Inability to comply with the study protocol
Comparing Bronchodilation of Symbicort With and Without Valved Holding Chamber (Aerochamber Plus)

This study will compare the amount of bronchial tube relaxation from the Formoterol medicine contained in the Symbicort pressure Metered Dose Inhaler(pMDI)(a combination of Budesonide, a steroid, and Formoterol, a drug which relaxes the bronchial smooth muscle. The comparison will be using the pMDI in the usual fashion to the pMDIs and a spacer which allows more time for breathing in the medication. Breathing tests will be measured over a 12 hour period for the comparison.

Sixteen subjects will receive treatment in a cross-over design. They will inhale Symbicort 160/4.5 two inhalations in the manner prescribed in the approved package insert. The second intervention will be the inhalation of Symbicort 160/4.5 two inhalations through a valved holding chamber (Aero Chamber Plus). Breathing tests including spirometry will be measured at various time periods over a 12-hour time frame in each intervention. Comparison will be made of the two periods to demonstrate that the use of the valved holding chamber does not adversely affect the bronchodilation of the formoterol component of the combination drug.

Eligibility Criteria:
Inclusion Criteria:

* Asthma with 15% or more increase in Forced expiratory volume at 1 second (FEV-1) after 180-360 mcg of albuterol pMDI

Exclusion Criteria:

* Any illness or condition which might place subject at risk in the study;e.g. some cardiovascular disorders Inability to understand and sign informed consent
Epidemiology of ST131 in Besançon University Hospital

The sequence type 131 (ST131) is a predominant lineage among extraintestinal pathogenic Escherichia coli. It plays a major role in the worldwide dissemination of E. coli that produce extended-spectrum beta-lactamase (ESBL). The aim of this study was to describe the epidemiology of ESBL producing ST131clonal group in our university hospital. All patients with an infection due to ESBL E. coli will be prospectively included for a 2-year period. ST131 isolates will be identified and risk factors associated to ST131 will be determined in comparison to non-ST131 ESBL E. coli.


Eligibility Criteria:
Inclusion Criteria:

* Patients infected with ESBL producing E. coli

Exclusion Criteria:

* Patients known to be carrier or infected in the previous year, patients only colonised with ESBL producing E. coli.
Efficacy of Behavioral Insomnia Treatment for Chronic Migraine

The purpose of this study is to test the efficacy of a brief behavioral insomnia intervention in reducing headache frequency and severity among patients with chronic migraine and insomnia. It is hypothesized that this intervention will produce greater changes in headache frequency and severity than will a comparison treatment involving non-sleep-specific general lifestyle modifications.

Chronic migraine (occurring 15 or more days per month) is a disabling disorder that engenders significant personal suffering and healthcare costs. Frequently, individuals with chronic migraine also suffer from symptoms of insomnia, the regulation of which has been shown to improve migraine. A variety of effective and well-validated behavioral treatments exist to reduce symptoms of insomnia but have not been widely applied to migraine patients. The goal of this study is to pilot test and compare the efficacy of 2 different behavioral (non-medication) treatments for chronic migraine, one of which addresses insomnia symptoms and one of which addresses general lifestyle changes, on headache and sleep parameters. Patients will be adults (18-65) diagnosed with chronic migraine and insomnia at the Oxford Neurology Clinic when they present for routine medical appointments. They will be maintained on usual medical care and referred to the Psychological Services Center for collection of baseline data and administration of the behavioral interventions. At baseline participants will be administered a structured interview and questionnaires pertaining to headache symptoms, sleep problems, and depression/anxiety. They will keep a daily diary of headache variables for 2 weeks and wear an actigraph on their wrist during baseline. Patients will be randomly assigned to receive either the a treatment focused on modifying general lifestyle behaviors (Lifestyle Modification; a replication of the instructions from Calhoun and Ford, 2007) or making changes to their sleep behaviors (Sleep Management) for 3 brief (20-30 min) sessions, spaced 2 weeks apart. Treatments will entail education/rationale about the intervention and a review of a set of instructions unique to each condition. Subsequent sessions will ensure compliance with the respective instructions. Daily monitoring of headache symptoms will continue throughout the trial. Participants will complete the aforementioned questionnaires at 2 posttreatment follow-up visits and wear the actigraph again for 2 week periods surrounding the 2 follow-up visits.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged 18-65 diagnosed with chronic migraine (15 or more days with headache per month, most of which must be migraine) and insomnia who present for routine medical care for migraine.

Exclusion Criteria:

* Currently pregnant or breastfeeding, being unable to read or speak English at a 6th grade level, alcohol or substance abuse or dependence, bipolar disorder or seizure disorder, psychiatric hospitalization within the last year, medication overuse headache, and patients not stable on current migraine medications.
Iv Amiodarone Versus Iv Procainamide to Treat Haemodynamically Well Tolerated Ventricular Tachycardia

The purpose of this study is to determine whether intravenous amiodarone has less cardiac significant adverse events compared to intravenous procainamide in the acute treatment of haemodynamically well tolerated wide QRS tachycardia, the majority of them of probably ventricular origen.

Multicenter, prospective and randomized study in phase IV. A total of 302 patients will be included in the study within 40-50 institutions in Spain. Patients with regular and monomorphic tachycardia ≥ 120 bpm, QRS ≥ 120 ms and haemodynamically well tolerated will be randomized to receive iv amiodarone (single dosage: 5 mg/kg in 20 minutes) vs iv procainamide (single dosage: 10 mg/kg in 20 minutes). The study period will be 40 minutes from infusion initiation. Study variables include the presence of clinically cardiac significant adverse events: hypotension, syncope, heart failure, symptomatic sinus bradycardia, AV block, proarrhythmia and tachycardia acceleration (\<20 lpm)and death. Total observation period will be 24 hours after the end of the infusion.

Eligibility Criteria:
Inclusion Criteria:

* Patients with stable tachycardia ≥120 lpm, QRS ≥120 ms and haemodynamically well tolerated defined as: 1)Systolic blood pressure ≥90 mmHg, 2) absence of dyspnea at rest, 3)absence of peripheric hypoperfusion signs and 4)no severe angina.
* Age \> 18 years
* Written inform consent obtained

Exclusion Criteria:

* Treatment with iv amiodarone or iv procainamide during the previous 24 hours
* QRS tachycardia \<120 ms
* Patients with QRS ≥120 ms tachycardia with haemodynamic compromise that requires urgent cardioversion for termination
* Irregular tachycardia
* Tachycardia that is considered as supraventricular due to physician criteria (adenosine and/or vagal manoeuvres response)
* Patient that do not want to cooperate
Molecular Epidemiology of Pediatric Germ Cell Tumors

A Non-Therapeutic Study that aims to establish a cohort of GCT survivors to understand short term and long-term adverse effects of treatment and to conduct molecular analyses to improve risk stratification.

PRIMARY OBJECTIVES:

I. Establish a survivorship cohort for pediatric and adolescent GCT comprised of participants from AEPI10N1 and APEC14B1 to assess short term and long-term adverse events associated with GCT treatment.

II. Compare somatic variation by tumor histology to identify molecular signatures that improve prognostic risk stratification.

III. Identify methylation patterns that predict poor clinical outcomes, including disease relapse and death.

OUTLINE:

Medical records from pediatric and adolescent Germ Cell Tumor (GCT) participants from AEPI10N1 and APEC14B1 will be used to obtain treatment information and validate self-reported outcomes. Paired normal and tumor samples will be used to evaluate single nucleotide variants, indels, copy number variations, and DNA methylation patterns. Ototoxicity will be determined by central review of audiogram files obtained from the treating institutions and self-reported based on questionnaire data.

Eligibility Criteria:
Inclusion Criteria:

* Cases will be eligible for the study if they have a primary diagnosis of GCT including germinoma (ICCC code105 9060-9065), teratoma (9080-9084), embryonal carcinoma (9070-9072), yolk sac tumor (9071), choriocarcinoma (9100, 9103, 9104), and mixed GCT (9085, 9101, 9102, 9105) in all sites including the brain.
* The patient must be enrolled on APEC14B1 with consent to future contact or enrolled in AEPI10N1 with consent for future contact (N=827). Patients enrolled in AEPI10N1 were recruited from ACCRN07. All patients must be registered with COG by a North American member institution. Note: (history of) treatment on a COG therapeutic trial is not required.
* Patients must be diagnosed at \< 20 years of age at the time of GCT diagnosis. Study participants will be followed over time in the survivorship study so there is no maximum age for participation.
* Participants must be able to complete study related documents in English or Spanish.
* All patients and/or their parents or legal guardians must provide informed consent. Assent will be obtained for participants between the ages of 8-17 years.
* All institutional, FDA, and NCI requirements for human studies must be met.

Exclusion Criteria:

* Participants from AEPI10N1 who did not consent to future contact. Patients who do not meet the eligibility criteria described above or cannot complete study materials in English or Spanish
Biweekly Versus Triweekly Raltitrexed With Oxaliplatin (With or Without Bevacizumab) in First-line Metastatic Colorectal Cancer

Raltitrexed is a potent thymidylate synthase (TS) inhibitor. Conversely to 5-fluorouracil (5FU), raltitrexed can be administered safely in patients with cardiovascular disease, as well as in patients with dihydropyrimidine dehydrogenase deficit. Since raltitrexed is administered in 15-minutes infusion, complications related to continuous infusion can be avoided, and it becomes a potential good candidate for locoregional treatments as hepatic intra-arterial or intra-peritoneal infusion. Despite these potential benefits over 5FU, clinical trials failed in their temptation to replace the 5FU in colorectal cancer patients, mainly due to raltitrexed toxicity at 3mg/m2 every 3 weeks. Oxaliplatin has demonstrated a synergic effect when combined with TS inhibitors, and its association with raltitrexed was evaluated at 130mg/m2 of oxaliplatin and 3mg/m2 of raltitrexed, every 3 weeks. Actually, one of the first-line standard regimens in metastatic colorectal cancer patients is the biweekly FOLFOX (85mg/m2 of oxaliplatin, and infusional 5FU) plus bevacizumab regimen, since a significant progression-free survival (PFS) benefit was observed over FOLFOX plus placebo. Biweekly administration of raltitrexed at 2mg/m2 demonstrated a favorable toxicity profile even in patients aged \>65 years. Besides, the association of raltitrexed, oxaliplatin and bevacizumab seems safe.

Then, the investigators decided to perform a randomized pharmacokinetic comparative study between biweekly TOMOX (raltitrexed 2 mg/m2 and oxaliplatin 85mg/m2) and triweekly TOMOX (raltitrexed 3 mg/m2 and oxaliplatin 130mg/m2) regimens in metastatic colorectal cancer patients, in a "ping-pong" crossover strategy to reduce the intra-individual variability. Bevacizumab was allowed at the dose of 5mg/kg or 7.5mg/kg, in biweekly and triweekly schedules, respectively. The secondary end-points were, objective response rate evaluated by RECIST 1.1 criteria, PFS, overall survival (OS), toxicity, and the comparison of toxicity between two arms for the first 2 cycles.


Eligibility Criteria:
Inclusion Criteria:

* performance status (ECOG-PS) of 0 or 1
* patient with histologically proven colorectal cancer with distant metastases
* measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
* life expectancy \> 12 months
* signed written informed consent

Exclusion Criteria:

* prior chemotherapy at metastatic stage
* presence of brain or meningeal metastases
* other malignancies in the past 5 years with the exception of adequately treated carcinoma in situ of the cervix and squamous or basal cell carcinoma of the skin
* preexisting peripheral neuropathy
* known hypersensitivity to any component of the study treatment
* any psychiatric condition compromising the understanding of information or conduct of the study
* pregnancy, breast-feeding or absence of adequate contraception for fertile patients
* patient under guardianship, curator or under the protection of justice
Robotic Top-down Intersphincteric Resection

The present study is to develop the novel robotic surgical technique and enhance the surgery quality for the treatment of distal rectal cancer.

The intersphincteric resection (ISR) for the treatment of distal rectal cancer has been a complex two-step surgical procedure consisting of transabdominal mobilization of the anorectum and transanal bowel resection with handsewn coloanal anastomosis. The availability of robotic systems may facilitate the transabdominal approach, simplify the surgical procedures, and achieve better anorectal function for patients with distal rectal cancer requiring an ISR. Consecutive 40 patients with distal rectal cancer undergoing the single-step robotic transabdominal ISR with the intent-to-treat principle will be recruited. The risk factors for a failed transabdominal ISR were identified from the prospectively maintained clinicopathologic data using univariate and multivariate analysis. The surgical outcomes, the anorectal function, and the tumor recurrence were compared between patients with a successful or failed robotic transabdominal ISR. The investigators believe that the present project can facilitate the development of the novel robotic surgical technique and enhance the surgery quality for the treatment of distal rectal cancer in our hospital and even in Taiwan.

Eligibility Criteria:
Inclusion Criteria:

* cT1-3 or yT 1-3 rectal adenocarcinoma whose low border was located below the anorectal sling (4 cm from anal verge), in which the required surgery meets the definition of ISR;
* Clinically Tumor-Node-Metastasis (TNM) stage I-III rectal adenocarcinoma;
* Curative and elective surgery;
* American Society of Anesthesiology (ASA) class Ⅰ to Ⅲ patients;
* Age between 20 and 75 years.

Exclusion Criteria:

* cT4 adenocarcinoma, i.e., the rectal cancer invaded to external sphincter or adjacent pelvic organs;
* Evidence of distant metastasis;
* Primary tumor mass≧8 cm in diameter;
* Morbidly obese patients, i.e., body mass index (BMI) ≧ 40 kg/m2 ;
* Previous major surgery of low upper abdomen;
* The adenocarcinoma has invaded to lateral pelvic side wall requiring a lateral pelvic lymph node dissection. (7) Patients with poor anorectal function (Wexner incontinence Score≧ 10)
Can the Femoral Nerve Block be Improved by Ultrasound Guidance?

Studies have suggested a link with effective pain relief and reduced illness and death in very unwell patients. This study will determine the most effective method of injecting local anaesthetic around the nerves which supply the hip joint. Local anaesthetic will be injected around the hips nerve supply using either ultrasound, loss of resistance or electrical nerve stimulator to guide the positioning of the needle on patients due for elective total hip replacement. The patient will then be observed for 30 minutes and the patient ability to move or feel the upper leg will recorded. A standard anaesthetic and a hip replacement operation will then be performed. Standard pain relief protocols will be used the operation and after the operation. After the operation we will record the amount of morphine used and how happy the patients have been with their treatment at 6 hours after the operation and at 24 hours after the operation. The first day the patient is able to walk on their new hip replacement will also be recorded.


Eligibility Criteria:
Inclusion Criteria:

* Elective primary total hip arthroplasty under general anaesthesia
* ASA\<=4
* Able to give informed consent
* Able to cooperate with sensory and motor testing of lower limb function

Exclusion Criteria:

* Abnormal clotting screen (coagulopathy) or thrombocytopenia (\<100,000)
* Acute mental test score of \<=7 at any time pre or post operatively
* Allergy to local anaesthetic
* Signs, symptoms or laboratory evidence of local infection or systemic sepsis
* No pre-existing neurological deficit (sensory or motor) affecting lower limb
* Patients with lower limb amputations
Rituximab or Zevalin - Efficacy Trial of Therapeutic Alternatives (RoZetta)

The purpose of this study is to evaluate the effect of consolidation treatment Zevalin® versus maintenance treatment with Rituxan® on progression-free survival (PFS) following response induction with chemotherapy plus rituximab in previously untreated participants with follicular lymphoma.

This is an open-label, multicenter and randomized study. Participants registered after response induction (PR/CR) to R-chemotherapy. Participants achieving either a partial response (PR) or complete response (CR) following R-chemotherapy eligible for randomization to either consolidation with 90Y-ibritumumab tiuxetan followed by observation for 24 months, or rituximab maintenance for 24 months. After the observation/maintenance period, patients follow up for 5 years.

This study was terminated early for business reasons. (Maximum duration of study was up to approximately 2.7 months).

Eligibility Criteria:
Inclusion Criteria:

* 18 to 75 years of age.
* Previously untreated with histologically confirmed grade 1, 2 or 3a cluster of differentiation-20 (CD20)-positive follicular lymphoma, with any of the GELF (Groupe d'Etude de Lymphomes Folliculaires) treatment criteria prior to induction.
* Achieved a response to induction treatment with either rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) (6 cycles of R-CHOP21 or R-CHOP14), rituximab-cyclophosphamide, vincristine and prednisone (R-CVP) (6 cycles), or rituximab-bendamustine (R-B) (4 to 6 cycles).
* Must have completed all doses of the induction treatment, except for the modifications allowed in the protocol.

Exclusion Criteria:

* Transformation to high grade lymphoma (secondary to "low grade" follicular lymphoma \[FL\]).
* Grade 3b follicular lymphoma.
* Primary follicular lymphoma of the skin or gastrointestinal tract.
* Previous treatment of follicular lymphoma.
* Altered renal and hepatic function.
* Known human immunodeficiency virus (HIV) infection and/or active hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection
* Serious co-morbid conditions (for example, ongoing infection, uncontrolled diabetes mellitus, gastric ulcers, active autoimmune disease).
* Life expectancy \< 6.
* Must have:

  * Platelet count ≥ 100x10\^9/L.
  * Bone marrow infiltration \<25%.
Dietary Calcium Intake in Premenstrual Syndrome

This study was planned and conducted to investigate effect of adequate calcium intake on Premenstrual Syndrome (PMS) symptoms in women with PMS who have inadequate calcium intake.

This study was planned and conducted to investigate effect of adequate calcium intake on Premenstrual Syndrome (PMS) symptoms in women with PMS who have inadequate calcium intake. Thirty one women, aged between 20-28 years, diagnosed with PMS and suitable for inclusion criteria, were participated in study. Participants were allocated to intervention (n=16) and control (n=15) groups randomly.

Eligibility Criteria:
Inclusion Criteria:

Women with;

* PMS who have inadequate calcium intake
* Regular menstrual cycle
* Menstrual flow which occurs every 22 to 35 days and last three to eight days

Exclusion Criteria:

* Having any of metabolic diseases
* Use oral contraceptive pill
* user vitamins and minerals supplements
* being smoker
Recurrence of Dyschezia in Rectal Prolapse, Rectocele and Elytrocele

Prolapse of the rectum is a pathology that preferentially affects older women with a significant impact on quality of life. A very large number of therapeutic approaches can be proposed (functional treatment, surgical techniques by perineal approach and surgical techniques by anterior approach).

D'Hoore and Pennix described Ventral Rectopexy with prosthetic reinforcement which is accepted as a standard of treatment in much of Europe for externalized prolapse but remains maligned in much of the world. Due to the relatively recent appearance of this technique and the great variability in the management methods, the long-term results of Ventral Rectopexy have been little studied.

This surgical technique is the preferred approach offered at CHU Grenoble Alpes. Pr Faucheron have internationally recognized experience in surgical grip with a very high patient volume in recent years.

Prolapse of the rectum is a pathology that preferentially affects older women with a significant impact on quality of life. A very large number of therapeutic approaches can be proposed (functional treatment, surgical techniques by perineal approach and surgical techniques by anterior approach).

D'Hoore and Pennix described Ventral Rectopexy with prosthetic reinforcement which is accepted as a standard of treatment in much of Europe for externalized prolapse but remains maligned in much of the world. Due to the relatively recent appearance of this technique and the great variability in the management methods, the long-term results of Ventral Rectopexy have been little studied.

This surgical technique is the preferred approach offered at CHU Grenoble Alpes. Pr Faucheron have internationally recognized experience in surgical grip with a very high patient volume in recent years.

The objective of this work is to describe the long-term results of this technique.

Eligibility Criteria:
Inclusion Criteria:

* Patient operated for rectal prolapse or enterocele for 10 or more
* Age 18 and over
* Patients informed

Exclusion Criteria:

- Patient opposition