cyrilzakka/clinical-trials huggingface dataset:
Hepatitis C Among Opioid Addicts in Opioid Maintenance Treatment in Zurich, Switzerland

Hepatitis C viral infection is common among opioid addicts in Zurich, Switzerland. The majority undergoes a maintenance treatment with methadone, heroin or buprenorphine. While stabilized by an opioid maintenance treatment (OMT)chronic hepatitis C can be treated with pegylated interferon plus ribavirin. As not sufficiently known, the results are comparable to the results of the treatment of nonaddicts.

Our crossectional study investigates how many patients undergoing OMT are adequately investigated concerning hepatitis C. If not, why are they not adequately investigated and treated? Representative data are collected in the local clinics and medical practices involved in OMT in the Kanton of Zurich. The patients files are revised and the involved doctors are asked through a structured interview.

www.seidenberg.ch/hepcop.pdf

Eligibility Criteria:
Inclusion Criteria:

* Medical practices and clinics involved in opioid maintenance treatment in the Kanton of Zurich, Switzerland
Preoperative Panitumumab and Radiotherapy in Rectal Cancer

The purpose of this study is to investigate the activity of panitumumab in combination with standard preoperative radiotherapy in locally advanced rectal cancer, followed by complete surgery and adjuvant chemotherapy.

The main hypothesis of the study is that the association of EGFR-targeting agent and radiation therapy could be as effective or even improve the rate of pathological complete tumoral response with fewer toxicities in comparison to the standard of care using chemoradiation therapy.

Anti-EGFR monoclonal antibodies have radiosensitizing properties. In particular, cetuximab in combination with curative-intent radiotherapy has been reported to increase median overall survival over radiation therapy alone in locally advanced head and neck carcinoma.

Similar benefit in rectal cancer is expected. However, preliminary studies revealed that the combination of chemoradiation and cetuximab did not seem to improve the pathological tumor response. However, in the past studies, the selection of patients' population was not optimal since KRAS mutational status was not considered during recruitments.

Therefore, new trials to investigate EGFR-targeting therapies in combination with radiotherapy in wild-type KRAS patients are required.

Adjuvant chemotherapy has also shown to decrease the risk of local relapse in patients who did not receive chemotherapy during radiotherapy. In our study, since there will be no chemotherapy given during the preoperative setting, the administration of adjuvant chemotherapy postoperatively is highly recommended.

Eligibility Criteria:
Inclusion Criteria:

* ECOG Performance Status 0-1
* Histologically proven adenocarcinoma of the rectum, T3-T4 and/or N+ M0
* Wild-type KRAS
* No prior pelvic irradiation
* Normal bone marrow, hepatic, renal, cardiac functions
* No secondary malignancy
* No other active, uncontrolled disease
* Signed informed consent

Exclusion Criteria:

* KRAS mutation
* Established or suspected metastasis
* Prior pelvic irradiation
* Previous exposure to EGFR-targeting therapies
* Patients under any other investigational agent(s)
* Concurrent systemic immune therapy, chemotherapy, hormone therapy
* Drug and/or alcohol abuse
* Grade 3 to 4 allergic reaction to any of the components of the treatment
* History or presence of interstitial lung disease
* Active, uncontrolled cardiovascular disease
Glove-loaded Foley's Catheter Tamponade for Cesarean Section for Placenta Previa

Objective: To investigate the effect of A glove-loaded Foley's catheter tamponade versus stepwise uterine devascularization on blood loss during cesarean section (CS) in patients with complete placenta previa.

Postpartum hemorrhage (PPH) due to placenta previa is usually from the placental bed at the lower uterine segment and it occurs after the placenta separation.

Despite placenta previa can be diagnosed by obstetrician before delivery nowadays, still a leading etiology of maternal mortality and morbidity.

Placenta previa is an obstetric condition that is closely linked with massive obstetric hemorrhage. Is not only associated with increased chance of requiring massive transfusion (\> 3 units of packed red blood cells) but also a is now the leading etiology of the cesarean hysterectomies. The incidence has progressively risen worldwide, mainly due to the increasing rates of cesarean section.

Uterine tamponade can be considered as a line of treatment before performing surgical procedures in PPH resulting from the placental site bleeding. It can save the life, avoid laparotomy and preserve fertility.

Nowadays, the use of intrauterine balloons has been developed and become effective for the control of placental site bleeding not responding to medical treatment.

The 2-way Foley's catheter has many advantages over the gauze packing; first, it allows drainage of blood, so no occult bleeding could be accumulated inside the uterus as in uterine gauze, second the removal of the Foley's catheter balloon is easy and not painful, third, the removal of 2-way Foley's catheter could be gradual as a test of its effectiveness before complete removal.

Bakri intrauterine balloon tamponade is used for the treatment of obstetric hemorrhage during cesarean delivery and many recent reports had described the successful use of balloon tamponade to manage hemorrhage due to placenta previa- with an overall success rate of 80%. However; its price is high so in our country, its availability and use are difficult.

So, the aims of this study to assess the effect of A glove-loaded Foley's catheter tamponade versus stepwise uterine devascularization on blood loss during cesarean section (CS) in patients with complete placenta previa.

The study will be single blinded randomized controlled trial carried out in a tertiary University Hospital between June 2018to June 2021. The included patients will be scheduled for CS due to complete placenta previa. They will be randomly allocated to the group (I) managed by stepwise uterine devascularization, group (II) managed by A glove-loaded Foley's catheter tamponade. The primary outcome will be the amount of intraoperative estimated blood loss.

Eligibility Criteria:
Inclusion Criteria:

* all pregnant women with a single-term fetus scheduled for elective CD for complete placenta previa

Exclusion Criteria:

* • Patients with the cardiac, hepatic, renal, or thromboembolic disease;

  * patients with the high possibility of morbid adherent placenta;
  * known coagulopathy, and
  * those presented with severe antepartum hemorrhage were excluded.
Psychosocial Approach and Sedation Practices

This study aims to explore deeply the representations and emotional impact of MS on caregivers (doctors and nurses) and relatives of cancer patients. It also aims to describe their collaboration modalities, roles and responsibilities during the decision-making process, implementation and "control" of MS. The project is a multi-center psychosocial study (home, hospitals and palliative care unit) that will take the form of a comprehensive qualitative study, both prospective (participant observation) and retrospective (interview), of patients with and without cancer, for which MS has been administered.

Scientific Background: Physicians have an ethical obligation to relieve the refractory symptoms of patients with advanced cancer. In some situations, in the face of physical symptoms and psycho-existential distress, usual treatment is not effective and palliative sedation (PS) is one of the only acceptable options. The carers, but also the relatives of the patient, are particularly involved in the process of decision-making, information and management of sedation. Despite the interest of MS practice and its impact on different levels (relational, emotional, professional, ethical), and contrary to the important development of international studies in this field, there is a lack of research in France.

Objectives of the project and a brief description of the methods: This study aims to explore in depth the representations and emotional impact of MS on carers (doctors and nurses) and relatives of cancer patients. It also aims to describe their collaboration modalities, roles and responsibilities during the decision-making process, implementation and "control" of MS. The project is a multi-center psychosocial study (home, hospitals and palliative care unit) that will take the form of a comprehensive qualitative study, both prospective (participant observation) and retrospective (interview), of patients with and without cancer, for which MS has been administered.

Expected Outcomes: The expected results are the production of original knowledge about the practice of MS in different clinical settings (hospital, home), a better understanding of the psychosocial determinants of palliative sedation decision-making, an update of knowledge transferable to develop palliative care programs that integrate the experiential, emotional, and contextual dimensions of palliative sedation, a better understanding of the communication skills needed to cope with this practice, and an awareness of health care teams and advocates. public health on this subject.

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Anyone from the team during the observation period
* Having accepted the presence of the observer
* Aged over 18

Exclusion Criteria:

* Members of the health care team not present during the observation period
* Member of the team refusing the presence of the observer
Nitrate Supplementation in Chronic Obstructive Pulmonary Disease (COPD)

Each subject will consume (in a randomized fashion) both the intervention beverage (nitrate solution) and the placebo, separated by a 1 wk washout period. The investigators will test the hypothesis that 7 days of dietary nitrate supplementation will improve metabolic efficiency in patients with COPD compared to the placebo.


Eligibility Criteria:
Inclusion Criteria:

* COPD
* Indication metabolic inefficiency

Exclusion Criteria:

* Sodium intake limitation
* Long-term oxygen therapy
* Severe renal impairment
* Use of medications that may interact with nitrate
* Contra-indications for performing (sub)maximal cycle ergometry
The Degree of Adherence of Pre-anesthetic Tests at Kasr Alaini Hospital to the NICE-Uk Guidelines

The aim of this study is to assess the effectiveness and usefulness of the current practice of various examinations ordered by anesthesiologists during the pre-anesthetic evaluation in patients who are intended for elective surgery in our hospital. We will also evaluate the effect of delay \& its value to predict postoperative complications.

For each preoperative requested test, we will determine whether the test is indicated based on the National Institute for Health and Clinical Excellence (NICE) guidelines and whether it was effective for adverse effects management or unnecessarily requested.

An adherent test was defined as a test that followed NICE, while a non-adherent test was defined as a test that included an over or under test. Normal test results are based on the laboratory reference range of normal values.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients that will be scheduled for an elective general surgical operation during our study time frame.

Exclusion Criteria:

* Patients that are operated on an emergency basis.
* Pregnant females.
* patients scheduled for cardiothoracic and neurosurgical procedures.
Vaccine Hesitancy Intervention--Provider (VHIP)

The primary aim of this trial is to test the effectiveness of an intervention to train primary care physicians to determine if it leads to decreased parental vaccine hesitancy.

The primary aim of this trial is to test the effectiveness of an intervention to train primary care physicians to determine if it leads to decreased parental vaccine hesitancy. The investigators will train primary care teams with an initial training followed by telephone coaching and follow-up visits, and assess the outcomes of parental vaccine hesitancy (primary) and physician self-efficacy (secondary) at baseline and 6 months.

Eligibility Criteria:
Study population:

* Eligible pediatric and family medicine practices in three counties in Washington State; King, Pierce and Snohomish Counties.
* Mothers whose infants will receive care in participating clinics.

Inclusion Clinics:

* Located in King, Snohomish, Pierce Counties, WA;
* Family practice clinics;
* Pediatric practice clinics;
* Order \> 1000 doses of vaccine in 2009 from State of Washington Department of Health.

Exclusion Clinics: Not willing to be randomized.

Inclusion Mothers:

* Babies born at participating hospitals;
* Mother can be recruited before discharged post-birth;
* Mothers declare pediatric care at one of participating clinics;
* Singleton or twin pregnancies.

Exclusion Mothers:

* Babies born \< 36 weeks gestational age;
* Known medical vaccine contraindications;
* Parental age \< 18;
* NICU;
* Triplet or more;
* Maternal complications.
Efficacy of Actos Lipitor Pegasys & Ribavirin in CHC GT 1 Patients Who Relapsed or Nonresponded to Peg/Riba

The aim of the study will be to determine if an insulin sensitizing thiazolidinedione plus a lipid lowering agent (statin) improves sustained virologic response rates in patients who have previously not responded or relapsed on standard pegylated interferon and ribavirin therapy.

The study will evaluate the use of atorvastatin and pioglitazone in the pre-treatment of insulin resistance and lipid levels prior to the addition of pegylated interferon and ribavirin for chronic hepatitis C (CHC). If improvement is seen in insulin resistance patients may then be in a position to respond more favorably to current antiviral therapy consisting of pegylated interferon and ribavirin.

This study could demonstrate the value of pretreating and continuing treatment for insulin resistance with pioglitazone in CHC, genotype 1 patients who have previously not responded or relapsed to prior pegylated interferon and ribavirin treatment. Changes in lipids are not a primary or secondary endpoint in this study.

Eligibility Criteria:
Inclusion Criteria:

* GT 1 previously treated with pegylated interferon \& ribavirin \& either non-responded or relapsed after cessation of therapy
* Insulin resistance
* Compensated liver disease

  * WBC \< 3,000/ mm3
  * Neutrophil count \< 1,500/mm3
  * Platelets \< 65,000/ mm3
  * Albumin \> 3 gm/dL

Exclusion Criteria:

* Participants on metformin or other thiazolidinedione must have 3month wash-out period
* Women who are pregnant or breast-feeding
* Males with pregnant partners
* Co-infection with HAV, HBV, or HIV
* Ophthalmic abnormalities such as severe retinopathy
* Poorly controlled thyroid dysfunction
* Serum creatinine concentration \> 1.5 times ULN
* Severe psychiatric or neuropsychiatric disorders
* History of alcoholism or drug addiction 1 year prior to screening
* Seizure disorders not controlled with medication
* Significant cardiovascular dysfunction within the past 12 months
* Chronic pulmonary disease
Long-term Treatment Study of Certolizumab Pegol Without Coadministration of Methotrexate in Japanese Rheumatoid Arthritis (RA) Patients

The objectives of this study are to evaluate the safety and efficacy of certolizumab pegol when administered without coadministration of methotrexate over the long term in Japanese RA patients who transferred from Study 275-08-003 (NCT00791921), and to evaluate the effects of different dosing regimens on the safety and efficacy of certolizumab pegol in American College of Rheumatology 20% (ACR20) responders who completed Study 275-08-003.

This study was initiated by Otsuka Pharmaceutical Co., Ltd and transferred to Astellas on 12/04/2012.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who participated in Study 275-08-003 and meet all of the criteria described below.

  * Patients who did not reach ACR20, and prematurely discontinued Study 275-08-003 at Week 16 or completed Study 275-08-003 by Week 24.

Exclusion Criteria:

* Patients who experienced an important protocol deviation as mentioned below during Study 275-08-003.
* Patients who received live or attenuated vaccines during Study 275-08-003 (Except for influenza or pneumococcal vaccines).
* Patients who were found to have tuberculosis on a chest X-ray during Study 275-08-003.
* Patients who required treatment for the same infection at two or more different times during Study 275-08-003
* Women who are pregnant, are lactating, of childbearing potential and wish to conceive during the study and post-study 3 months.
* Patients whom the investigator has decided to be inappropriate for participation in the study
Impact of OFA During LPV on Postoperative Oxygen Saturation

Opioids used intra operative increase the amount of opioids needed post operative to control post operative pain. if opioids are given post operative, we assume that more atelectasis and hypoxia takes place even after lung protective ventilation. These postoperative lower oxygen saturations will require giving more frequent oxygen therapy.

This is an observational study where the attending anesthesiologist decides to use opioid free or opioid general anesthesia based on his/her expertise.

Every patient gets a lung protective ventilation and emergence from anesthesia using the principles set forward in the consensus meeting by Young C BJA 2019.

A lung recruitment followed by high PEEP is given when lung compliance decreases below 40 ML/cmH20. The lowest oxygen saturation without adding oxygen therapy is noted post extubation at moment of admission in PACU, after having given an opioid as analgesic and at moment of discharge from PACU..

If post operative satuation drops below 94% oxygen therapy is given and noted.

Eligibility Criteria:
Inclusion Criteria:

* major surgery where intubation with mechanical ventilation is required
* obese patients with BMI \> 35

Exclusion Criteria:

* spontaneous breathing during procedure
* allergic to any of the drugs used in both groups
* severe liver, renal, cardiac or pulmonary disease
Evaluation of the Effects of Etifoxine 100 mg and Lorazepam 2 mg on Vigilance and Cognitive Functions in the Elderly

The purpose of this study is to evaluate the effects of etifoxine (an anxiolytic) compared to lorazepam (a benzodiazepine anxiolytic) on vigilance and cognitive functions in the elderly.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman aged from 65 to 75 years
* Right-handed subject (Edinburgh Handedness inventory)
* Subject having signed the consent form
* Subject having agreed to be listed on the French National Healthy Volunteers database
* Subject affiliated or beneficiary to French social insurance

Exclusion Criteria:

* Subject presenting a neurological or psychiatric disease notably cognitive, progressing
* Anxious subject (Hamilton score \> 7 and/or Spielberger score \> 51 for a man or \> 61 for a woman)
* Left-handed subject (Edinburgh Handedness inventory)
* Subject presenting a not corrected visual disease or a motor function disease that could interfere with tests realization
* Smoker
* Subject taking one or more psychotropics or apparent products
* Subject having taken, during the previous month, one or more drugs that could interfere with study drugs metabolism
* Subject drinking too much coffee or tea (\> 4 cups per day) or alcohol (\>½ liter of wine or equivalent per day)
* Subject presenting contra-indication to one of the drugs used in the study
* Subject with past history of intolerance to drugs used in the study
* Subject not capable to use the CANTAB cognitive evaluation system
* Subject which may not be able to participate to the whole study
* Subject under tutelage or guardianship
* Subject not able to well-understand French and so to understand cognitive tests
* Subject not capable to swallow capsules
* Subject participating to another study or in exclusion period (3 months after a previous trial).
Prospective Randomized Optical Coherence Tomography Oslo tRial

Coronary artery intervention with stents is a routine procedure with several clinical indications. A stentfailure, ie stentrestenosis and/or stentthrombosis will occur in some patients. Several different mechanisms have been suggested. Stentfailure may be caused by mechanical properties of the stent. This may be secondary to suboptimal stentimplantation, ie over/undersizing or acquired ie malapposition or stentfracture. These stentproperties may be difficult to identify with conventional coronary angiography due to low image resolution. The hypothesis of the study is that high resolution imaging with optical coherence tomography (oct) will improve diagnosis and enable a more specific or tailored treatment with a subsequent reduction in later stentfailure.

The hypothesis of the PROCTOR study is that high resolution imaging with optical coherence tomography (oct) will improve diagnosis and enable a more specific or tailored treatment in stent failure. However, the prevalence of stentfailure (ie stent malapposition, stentfracture, stentedgedissections etc) not causing clinical endpoints is not known. In a subset of patients (n=100) with previously implanted stents performing a new coronary angiography based on clinical indication, functional or patent stents (decided by Heart team) will be characterized with OCT and the patients followed for 5 years. The purpose of this substudy, OCT IPS (OCT In Patent Stents), is to estimate the prevalence of stentpathology in patent or functional stents and compare findings with the active arm of PROCTOR.

Eligibility Criteria:
Inclusion Criteria:

Clinical indication for coronary angiography and intervention due to stentfailure, both stentrestenosis and stentthrombosis in stable patients or unstable patients with acute coronary syndrome.

Exclusion Criteria:

* Patient not able to give informed consent.
* Unwillingness.
* Life expectancy \< 5 years.
* Reduced kidney function with GRF\<45.
* Coronary artery diameter \< 2.5mm.
* Pregnancy.
* Patients without 11-digit Norwegian personal number.
Weekly Topotecan in Patients Treated for Metastatic Colorectal Cancer

This non-randomized phase II study is designed to assess the response rate and toxicity of weekly topotecan as second-line treatment in patients with relapsed or refractory metastatic colorectal cancer.

Upon determination of eligibility, patients will be receive:

* Topotecan

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Metastatic colorectal cancer
* One previous chemotherapy for metastatic disease
* Measurable or evaluable disease
* Able to perform activities of daily living with assistance
* Adequate bone marrow, liver, and kidney function
* All patients must give written informed consent prior to study entry.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Brain or meningeal involvement
* Serious active infection or underlying medical conditions
* Other active neoplasms are ineligible
* Pregnant or lactating

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.