cyrilzakka/clinical-trials huggingface dataset:
S9700 Combination Chemotherapy in Treating Patients With Stage II or Stage III Pancreatic Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Chemotherapy following surgery may be an effective treatment for pancreatic cancer.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with stage II or stage III pancreatic cancer that has not been surgically removed.

OBJECTIVES: I. Assess the one year overall survival rate of patients with advanced, unresectable pancreatic cancer treated with fluorouracil, leucovorin, mitomycin and dipyridamole. II. Assess the response rate in this group of patients. III. Evaluate the frequency and severity of the toxic effects associated with this therapy. IV. Assess the rate of resectability in patients who respond to therapy.

OUTLINE: All patients undergo surgical placement of an indwelling central venous line. Patients receive fluorouracil IV by continuous infusion on days 1-28, leucovorin calcium IV on days 1, 8, 15, and 22, oral dipyridamole on days 1-28, and mitomycin IV every 6 weeks starting on day 1. Treatment repeats every 6 weeks for 4 courses. Patients with a partial or complete response are reevaluated for possible surgical resection. Resected patients resume chemotherapy 4-8 weeks after surgery for an additional 16 weeks. Patients are followed every 6 months for 2 years, then annually until death.

PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically proven stage II or III pancreatic adenocarcinoma Ductal adenocarcinoma Mucinous noncystic carcinoma Signet ring cell carcinoma Adenosquamous carcinoma Undifferentiated (anaplastic) carcinoma Mixed ductal-endocrine carcinoma Well differentiated adenocarcinoma Moderately well or poorly differentiated adenocarcinoma Undifferentiated ductal carcinoma Must have unresectable and localized disease Measurable or evaluable disease

PATIENT CHARACTERISTICS: Age: Not specified Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: Not pregnant or nursing Fertile patients must use effective contraception Loss of no greater than 15% of actual body weight Oral intake of greater than 1,200 calories per day No other malignancy within the past 5 years except adequately treated basal or squamous cell skin cancer, carcinoma in situ of the cervix, or any stage I or II cancer that is currently in complete remission

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior systemic chemotherapy for pancreatic cancer Endocrine therapy: Not specified Radiotherapy: No prior radiation therapy for pancreatic cancer Surgery: At least 2 weeks since prior surgical bypass procedure and recovered
Newer Versus Older Antihypertensive Agents in African Hypertensive Patients (NOAAH) Trial

The purpose of this study is to compare the blood pressure lowering efficacy of a treatment regimen based on a dihydropyridine calcium-channel blocker combined with an angiotensin II type-1 receptor blocker with the recommended treatment regimen based on a low-dose thiazide diuretic combined with a beta-blocker.

Primary objective:

Sitting systolic blood pressure (average of three readings) will be the primary outcome variable.

Secondary

1. To compare the time interval between the two treatment groups, which after randomisation will be required, to reach and maintain the target defined as a blood pressure below 140 mm Hg systolic and 90 mm Hg diastolic;
2. To compare the duration of follow-up, during which a steady blood pressure control will be achieved;
3. To evaluate the incidence of adverse events, symptoms, biochemical abnormalities and ECG changes in the two treatment groups;
4. To assess the adherence to antihypertensive treatment as well as the rate of drop-outs in both treatment arms during a six-month period.

Eligibility Criteria:
Inclusion Criteria:

* Women or men within an age range from 30 to 69 years with uncomplicated hypertension.
* Blood pressure measured in the sitting position after at least 5 minutes rest (average of three readings at the last run-in-visit) should range from 140 to 179 mm Hg systolic or from 90 to 109 mm Hg diastolic (grades 1 or 2 of hypertension). Patients must have uncomplicated hypertension with a maximum of two additional risk factors, as defined in the 2007 guidelines of the European Societies of Hypertension and Cardiology.
* Systolic blood pressure in the upright position must be at least 110 mm Hg (mean of three readings obtained immediately after the patient has assumed a standing position).
* Patients who have never been treated for hypertension or in whom previous antihypertensive drug treatment has been discontinued for at least four weeks before the last run-in visit can be randomised. If two weeks after discontinuation of previous antihypertensive treatment the blood pressure is higher than 160 mm Hg systolic or higher than 100 mm Hg diastolic and if the patient has complaints, the patient can be randomised immediately to active blood pressure lowering treatment with either the newer or older antihypertensive drugs.
* The patient must provide informed written consent.

Exclusion Criteria:

* Premenopausal women not applying anticonception.
* A history of cardiovascular disease.
* Secondary hypertension.
* Electrocardiographic left ventricular hypertrophy.
* More than two cardiovascular risk factors in addition to hypertension.
* Diabetes mellitus.
* Renal dysfunction.
* Recent treatment with two or more antihypertensive drugs or a contra-indication to discontinue blood pressure lowering agents for 4 weeks.
* Severe non-cardiovascular disease.
* Known contra indications for the first-line study medications.
Post-marketing Study to Collect Safety Data in Heart Transplant Patients Receiving Everolimus

The purpose of this observational protocol is to evaluate the use of everolimus in routine clinical practice for heart transplants.

Primary outcome measures: incidence of acute rejection episodes Secondary outcomes: safety


Eligibility Criteria:
Inclusion Criteria:

* Cardiac transplant recipients
* Discharged alive from hospital
* Must be receiving everolimus

Exclusion Criteria:

* Patients not treated with everolimus beginning within 2 weeks after receiving a heart transplant

Other inclusion/exclusion criteria may apply.
Study to Improve the Treatment of Epilepsy (SITE)

The purpose of this study is to assess whether changing antiepileptic medication can reduce side effects and improve the quality of life in patients with epileptic seizures that are well controlled with antiepileptic drugs.

Background. The aim of the treatment with antiepileptic drugs (AEDs) is to achieve seizure freedom without causing side effects. Assessment of side effects is difficult. They may start insidiously, the patient may not associate certain complaints with the use of AEDs, or the treating physician does not take enough time to discuss this topic during the limited time of a visit in the outpatient department. We know from clinical trials that side effects occur in a substantial group of patients. We do not know whether we deal with this possible complication in an adequate way in clinical practice.

Study objective. To study whether adjustment of medication will reduce the occurrence of side effects and improve quality of life.

Study design. A randomised clinical trial comparing adjustment of treatment in case of relevant side effects to continuing treatment unchanged. Relevant side effects are defined as at least one moderate or serious problem scored on a questionnaire to assess complaints in people with epilepsy.

Patients who do not report relevant side effects will be followed for 13 months (arm A) in which two visits are scheduled, after 7 and 13 months respectively.

The patients who do report relevant side effects will be randomised to either discussion of the questionnaire results and adjustment of treatment if appropriate (arm B) or to ignore the results of the questionnaire and continue treatment unchanged (arm C). Investigations will be repeated in both groups after 7 and 13 months after the initial visit.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Treatment: antiepileptic drugs for epilepsy
* No change in medication during last 6 months
* No obvious clinical reason to change medication immediately

Exclusion Criteria:

* Concurrent disease or disorder that might interfere with the conduct of the study
* Inability to comply to the protocol
* Impaired intellectual functioning, leading to inability to comply to the protocol and complete the necessary questionnaires
Emotional Proactive Processing in Bipolar Disorder

The main objective of this project is to identify behavioral specificities of the proactive emotional brain among bipolar patients, compared to healthy subjects. These could contribute to some of the emotional processing biases that can be observed in these patients. To achieve this goal, two behavioral tasks will be administer (emotional stroop and emotional stimuli categorization task) to bipolar patients and control subjects, and their performances will be compared.

This is a case-control non-interventional study comparing bipolar patients to matched healthy controls during one assessment visit at the University Hospital of Grenoble.

The experimentation phase takes place in three stages: first, the experimenter collects demographic data (age and level of study, lack of medical history and treatments that may interfere with the task). For bipolar subjects, it also collects the type of bipolarity, the type and date of the last episode, the age of the onset of the disease and the treatment.

Secondly, the subject performs a classic Stroop task lasting 3 to 5 minutes, including instructions.

Finally, the subject performs the two main tasks: the emotional Stroop task lasting about 20 minutes and then the task of emotional stimuli categorization lasting about 15 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Right-handed
* Francophones
* Bipolar disorder diagnosis (for patients) according to DSM-5 / CIM-10 criteria
* Affiliation to the French social security insurance

Exclusion Criteria:

* uncorrected perceptual disturbance
* psychiatric disorders other than bipolarity as the main psychiatric disorder or a condition which may affect the tasks proposed for the patients' group
* subject under legal protection
* subject deprived of freedoms by a judicial or administrative decision
* drug abuse less than 12 hours before the assessment
Supporting Traumatic Brain Injury (TBI) Caregivers

This randomized trial tested a 6 month intervention of computer network vs a control group (standard care) to improve quality of life and health status for traumatic brain injury (TBI) patients and their caregivers. The network, termed the Trauma Recovery Support System (TRSS), consisted of a central computer system connected via modem to a personal computer in the caregiver's home. Users could access via the Internet special modules and communication services to help them cope with their new roles as caregivers and with accompanying social isolation. These modules were an on-line discussion group, an "ask an expert questions" function, a database of previously asked questions with answers, a database of community resources, and a reference library.

Traumatic brain injury (TBI) has long-term and often devastating impacts on a family. The spouse or partner caring for an individual with TBI experiences significant emotional distress, and psychological and physical morbidity. Clinical experience indicates that patients with strong family support progress further than those without family involvement. There is strong evidence that support provided to caregivers improves their well being, as well as that of the care recipient. The trial was designed to lessen her morbidity, improve her support for the TBI partner, and improve recovery of the TBI person.

The effectiveness of a newly developed Trauma Recovery Support System (TRSS) was evaluated using a randomized controlled experimental design. Sixty-four patient/caregiver pairs were recruited, and those (randomly) assigned to the experimental group received access to the centralized TRSS via a personal computer in their homes including access via Internet to special modules and communication services to help them cope with their new roles as caregivers and with accompanying social isolation. Modules consist of an on-line discussion group, an "ask an expert questions" function, a database of previously asked questions with answers, a database of community resources, and a reference library. Controls received standard care. All participants (experimental and control) were interviewed at 0, 3, and 6 months from time of patient discharge, initially in person and later by phone to evaluate the status of the caregiver (quality of life and health status) and TBI patient recovery. Sociodemographic and other background data was collected.

Eligibility Criteria:
Inclusion Criteria:

* Male/female pairs (both at least 18 years of age), where male is recovering from traumatic brain injury (Ranchos Los Amigos Scale class of 1-8) and female spouse/partner is the caregiver

Exclusion Criteria:

* Caregiver (female) not able to read and write English well enough to answer review's questions
* Patients cared for by children, siblings or parents (as opposed to spouse/partner)
* Patients discharged to locations other than home
* Female patients with male caregivers
A Study of ZW191 in Participants With Solid Tumors

The purpose of this study is to find out if ZW191 is safe and can treat participants with advanced cancers, including ovarian, endometrial, and non-small cell lung cancers.

Part 1 of the study will evaluate the safety and tolerability of ZW191. Part 2 of the study will further evaluate safety and explore the potential anti-tumor activity of ZW191.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically or cytologically confirmed diagnosis of cancers with evidence of locally advanced (unresectable), recurrent and/or metastatic disease.
* Measurable disease per RECIST v1.1.
* Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
* Adequate cardiac function: Cardiac left ventricular function, as defined by left ventricular ejection fraction (LVEF) ≥ 50% as determined by either echocardiogram (ECHO) or multigated acquisition scan (MUGA).
* Other adequate organ function.

Exclusion Criteria:

* Known additional malignancy that is progressing or requires active treatment or may interfere with study endpoints.
* Has received prior Topoisomerase I inhibitor(TOPO1i) antibody drug conjugate treatment, regardless of washout period.
* Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease.
* Severe chronic or active infections (including known active SARS-CoV-2 infection) requiring systemic therapy, including antibacterial, antifungal, or antiviral therapy.
Validation of Surrogate Measures in Irritable Bowel Syndrome (IBS)

Visceral and somatic hypersensitivity as evidence of central sensory sensitization occur in the majority of Irritable Bowel Syndrome (IBS) patients. We recently demonstrated abnormal endogenous pain modulation as a cause of the sensitization in IBS and identified the underlying dysfunctional neuromatrix using functional MR-imaging (fMRI). Endogenous pain mechanisms regulate, fine-tune and integrate sensory and homeostatic, including neuroendocrine, immune and autonomic nervous system processes. Specific measures of sensitization and endogenous pain modulation correlate with clinical measures of somatic and neuropathic pain, suggesting usefulness as surrogate markers for clinical pain outcomes. Validation of experimental measures as surrogate markers in IBS would provide a considerable advance in pathophysiological and therapeutic research in this pharmacoeconomically burdensome disease.


Eligibility Criteria:
Inclusion Criteria:

IBS patients:

* One hundred fifty male and female IBS patients (Rome III criteria), aged 18 to 70 years, recruited from primary and secondary care via advertisements and referral networks.
* Minimum IBS symptom rating of 75 in IBS severity scoring system (IBS-SSS) in last two weeks.
* IBS discomfort or pain must have been patient's most prominent symptom.
* A minimum of 40 patients each IBS-constipated (IBS-C) and IBS-diarrhoeic (IBS-D) (Rome III) to be included.
* Patients must have been off all IBS and analgesic medication and any drugs potentially influencing sensory function for at least two weeks before study start.

Healthy controls:

* Fifteen healthy controls aged 18 to 70 years without any gastrointestinal pathology or history of significant abdominal pain, bowel disorders, bloating or discomfort during the last 3 months.

Exclusion Criteria:

Exclusion criteria for both IBS patients and healthy controls:

* Organic gastrointestinal or other significant systemic disease, including cardiovascular, psychiatric, neurological and endocrine diseases, as judged by investigator
* Chronic or acute pain, except related to other functional syndromes (functional dyspepsia, chronic pelvic pain, fibromyalgia, migrane)
* Bowel resections (except appendectomy)
* Multiple abdominal operations, excluding hysterectomy
* History of brain disease or brain surgery
* Ongoing treatment with any anticoagulants, antidiabetics, antimigraine drugs, antispasmodics, analgesics, psychoactive agents including antidepressants, Zelmac®, TCM or acupuncture for IBS and any drugs affecting nociception as judged by investigator within last 14 days
* Treatment with any investigational drug during the preceding 30 days
* Pregnancy or lactation.
* Claustrophobia
* Metal implants in body (fMRI exclusion criterion)
* No written informed consent obtained from subject
Left Atrial Appendage Occlusion With WATCHMAN® Device in Patients With Non-valvular Atrial Fibrillation and End-stage Chronic Kidney Disease on Hemodialysis

Atrial fibrillation (AF) is more common in patients with renal disease compared to the general population an risk increase to as much as 10 times in patients on hemodialysis (HD). Stroke is an important cause of morbidity, mortality and suffering for patients with end-stage chronic kidney disease (ESCKD) on hemodialysis.The risk of bleeding in these patients can be roughly 5-fold higher that without it. Current guidelines recommend the use of oral anticoagulants (AO) to prevent stroke or systemic thromboembolism in high-risk patients with AF. Left atrial appendage occlusion (LAAO) reduces the risk of bleeding while allows thromboembolic stroke prevention. The aim of the study is to assess the procedural safety on stroke and bleeding prevention of LAAC in patients with non-valvular atrial fibrillation (NVAF) and ESCKD on HD.

Atrial fibrillation (AF) is more common in patients with renal disease compared to the general population an risk increase to as much as 10 times in patients on hemodialysis (HD). Stroke is an important cause of morbidity, mortality and suffering for patients with end-stage chronic kidney disease (ESCKD) on hemodialysis.The risk of bleeding in these patients can be roughly 5-fold higher that without it. Current guidelines recommend the use of oral anticoagulants (AO) to prevent stroke or systemic thromboembolism in high-risk patients with AF. Left atrial appendage occlusion (LAAO) reduces the risk of bleeding while allows thromboembolic stroke prevention.

Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years.
* Stage V chronic kidney disease (GFR \<15 ml / min) in hemodialysis at the time of left atrial appendage closure.
* History of atrial or valvular fibrillation (paroxysmal, persistent, permanent).
* Less moderate embolic risk (CHA2DS2-VASc ≥2) or active oral anticoagulant therapy due to atrial fibrillation.
* High associated hemorrhagic risk (HASBLED ≥ 3) or a history of major bleeding (BARC\> 2).
* The patient has been informed of the characteristics of the study and has provided written informed consent.

Exclusion Criteria:

* Life expectancy \< 2 years.
* Indication for OA different from NVAF.
* Severe pericardial effusion.
* Previous percutaneous closure of atrial septal defect.
* Intracardiac thrombus.
* Severe hepatic dysfunction with spontaneous INR (International Normalized Ratio) \> 1.5.
* The patient refuses to participate in the study.
Study of Nitazoxanide, Peginterferon Alfa-2a and Ribavirin for the Treatment of Hepatitis C

The purpose of this study is to determine if nitazoxanide in combination with peginterferon alfa-2a and ribavirin is safe and effective in treating chronic hepatitis C in patients that have previously failed to respond to treatment with peginterferon and ribavirin.


Eligibility Criteria:
Inclusion Criteria:

* Chronic hepatitis C genotype 1.
* Failed to respond to ≥12 weeks of peginterferon and ribavirin (\<2 log10 drop in Hepatitis C Virus Ribonucleic Acid (HCV RNA) at week 12 or detectable Hepatitis C Virus Ribonucleic Acid (HCV RNA) at week 24).

Exclusion Criteria:

* Females of child-bearing age who are either pregnant, breast-feeding or not using birth control and are sexually active.
* Males whose female partners are either pregnant or of child-bearing potential or not using birth control and are sexually active.
* Other causes of liver disease including autoimmune hepatitis.
* Transplant recipients receiving immune suppression therapy.
* Screening tests positive for Anti-Hepatitis A Virus Immunoglobulin M Antibody (anti-HAV IgM Ab), Hepatitis B's antigen (HBsAg), Anti-Hepatitis B core antigen Immunoglobulin M Antibody (anti-HBc IgM Ab) or Anti-Human Immunodeficiency Virus Antibody (anti-HIV Ab).
* Decompensated cirrhosis, history of variceal bleeding, ascites, hepatic encephalopathy, Child-Turcotte-Pugh (CTP) score \>6 or Model for End-stage Liver Disease (MELD) score \>8.
* Alcohol consumption of \>40 grams per day or an alcohol use pattern that will interfere with the study.
* Absolute neutrophil count \<1500 cells/mm3; platelet count \<135,000 cells/mm3; hemoglobin \<12 g/dL for women and \<13 g/dL for men; or serum creatinine concentration ≥1.5 times Upper Limit of Normal (ULN).
* Hypothyroidism or hyperthyroidism not effectively treated with medication.
* Hemoglobin A1C (HgbA1c) \>7.5 or history of diabetes mellitus.
* Body Mass Index (BMI) \>28.
* History or other clinical evidence of significant or unstable cardiac disease.
* History or other clinical evidence of chronic pulmonary disease associated with functional impairment.
* Serious or severe bacterial infection(s).
* Ulcerative or hemorrhagic/ischemic colitis.
* Pancreatitis.
* History of severe or uncontrolled psychiatric disease, including severe depression, history of suicidal ideation, suicidal attempts or psychosis requiring medication and/or hospitalization.
* History of uncontrolled severe seizure disorder.
* Requires concomitant theophylline or methadone.
* History of immunologically mediated disease requiring more than intermittent anti-inflammatory medications for management or that requires frequent or prolonged use of corticosteroids.
* History or other evidence of severe retinopathy or clinically relevant ophthalmological disorder due to diabetes mellitus or hypertension.
* Hemoglobinopathies.
* History of hypersensitivity or intolerance to nitazoxanide or any of the excipients comprising the nitazoxanide tablets, peginterferon alfa-2a injectable solution or ribavirin tablets.