cyrilzakka/clinical-trials huggingface dataset:
Ziconotide for Non-cancer Pain by Intrathecal Administration

Although ziconotide's marketing authorization does not restrict its use to a given type of pain, the drug has been used mainly in cancer patients. Most data on ziconotide-based intrathecal (IT) treatment has therefore been obtained in this population, for whom the drug's place is clearly documented (national and international recommendations).

In contrast the management of non-cancer pain is less straightforward, partly because of the very large range of possible clinical conditions, and the utilization of ziconotide is poorly documented, mainly described in single-centre small series.

Due to the lack of data, physicians are often reluctant to undertake this type of treatment, which may represent a loss of opportunity for patients.

This registry aims at providing information on patients suffering from non-cancer pain refractory to standard therapy, treated by ziconotide-based intrathecal analgesia.

Patients suffering from all types of non-malignant pain will be eligible for the study, including but not limited to spinal cord injury, radiculopathy, failed back surgery, diabetic neuropathy, central pain syndrome, complex regional pain syndrome, chemotherapy-induced neuropathy, fibromyalgia.

The collected data will cover the first 2 years of treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years,
2. Chronic non-cancer pain requiring interventional techniques, and eligible to ziconotide-containing intrathecal therapy,
3. Having received information on and not opposed to data collection,

Inclusion criteria specific for the retrospective cohort:

Currently treated by ziconotide-based ITA according to SmPC whatever the duration of treatment

Inclusion criteria specific for the prospective cohort:

Naïve of ITA and candidate to ziconotide-based ITA or already treated by IT route without ziconotide, scheduled for addition of ziconotide in the pump

Exclusion Criteria:

1. Contraindication to intrathecal therapy or to ziconotide
2. Any condition that may jeopardize appropriate follow-up of the treatment
3. Patient under guardianship or deprived of liberty by a judicial or administrative decision or unable to express opposition to data collection.
Radiotherapy Combined With Thymosin for Metastatic NSCLC Patients Who Showed Stable Disease After First Line TKI Therapy

The investigators postulated that the exploitation of the pro-immunogenic effects of radiotherapy with thymosin might result in abscopal responses among patients with metastatic cancer. The research is designed to evaluate the efficacy and toxicity of patients treated with hypofractionated radiotherapy combined with thymosin alpha 1. An exploratory biomarker analysis in blood and tumor samples is also planned.


Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed metastatic lung adenocarcinoma harboring sensitizing EGFR mutations (L858R, exon 19 deletion), and showed stable disease after 3 months TKI, evaluated twice by PET/CT scan, brain MRI, and abdomen ultrasound (≥3 measurable lesions, and these lesions haven't received local therapy)
* Age 18 years or older
* ECOG Performance Status 0-2
* Adequate bone marrow, liver and renal function, as specified below: Absolute Neutrophil Count (ANC) ≥ 1.5 x 109/L; Hemoglobin ≥ 8 g/dL; Platelets ≥ 100 x 109/L; Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN) ; AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN if liver metastases are present; Serum creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60ml/min for patients with creatinine levels above institutional normal
* For women of child-bearing potential, negative pregnancy test within 14 days prior to starting treatment
* Men and women of childbearing age must be willing to use effective contraception while on treatment and for at least 3 months thereafter
* Patients and their family signed the informed consents

Exclusion Criteria:

* Received chemotherapy before TKI therapy
* Brain parenchyma or leptomeningeal disease
* Concurrent malignancies other than non-melanoma skin cancer that require active ongoing treatment
* Any medical co-morbidities that would preclude radiation therapy.
Impact on Elderly Skin Due to Wet Pad Application.

The clinical study aims to measure the changes in the stratum corneum on older healthy participants due to the application of a wet pad on the forearm. Participants are subject to baseline measures of TransEpidermalWaterLoss (TEWL), skin hydration (SH), pH and water profile (raman spectroscopy). Dry or wet pads are then added to the skin and worn for two hours. After a recovery period, the SkinSurfaceWaterLoss (SSWL) and skin hydration and water profile is measured. The study is conducted over a single visit. Pads on the arms consist of incontinence product cutouts and are loaded to 50% or 100% capacity. The endpoints are the changes in stratum corneum as measured by the instruments during the visit.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women ≥ 65 years.
2. Mentally and physically able to participate in this study.
3. Written informed consent to participate in this study.
4. Intact skin on the volar forearms without skin irritation.

Exclusion Criteria:

1. Have any known allergies or intolerances to one or several components of the absorbing incontinence product.
2. Suffer from excessive sweating, hyperhidrosis.
3. Have any other condition that makes participation in the clinical investigation inappropriate, as judged by investigator.
4. Not be of childbearing potential.
5. Have an alcohol and/or drug dependency.
PALS for Nutrition Education

The overall goal of this inquiry is to determine whether PALS is more effective than comparable online resources at educating patients in the outpatient clinic setting about nutrition. Participants will be randomly assigned to view either a PALS article or WebMD article on the same nutrition topic. Participants will then fill out a post-survey to assess knowledge uptake and attitudes regarding healthy eating.


Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years of age.
* Ability to speak and read in English.
* Passing the screener - Mini-Mental Status Examination.
* Patient at WCIMA clinic on Upper East Side of Manhattan, NY.

Exclusion Criteria:

* Non-English speakers
* Inability to read in English
* Being younger than 18
* Not passing the screener
* Not a patient at WCIMA clinic on Upper East Side of Manhattan, NY.
Kinesiology Taping Technique in Post-mastectomy Breast Cancer Related Lymphedema

Generally, Breast cancer related to lymphedema is commonly found in the female population after mastectomy. It has many complications which affects the normal functions of an individual and quality of life. This randomized control trial will be conducted on patients who are admitted as patients after mastectomy to determine the effects of kinesiology taping technique in post mastectomy breast cancer related lymphedema on swelling, upper limb function and strength.

Generally, Breast cancer related to lymphedema is commonly found in the female population after mastectomy. It has many complications which affects the normal functions of an individual and quality of life. Traditional therapies like compression decongestive therapies and kinesiology taping techniques are used for the management of post mastectomy breast cancer related lymphedema.This randomized control trial will be conducted on patients who are admitted as patients after mastectomy to determine the effects of kinesiology taping technique in post mastectomy breast cancer related lymphedema on swelling, upper limb function and strength. Total 50 patients with post mastectomy who fulfill the inclusion criteria will be selected after taking consent. The subjects will be allocated into two groups through simple random sampling. Subjects ingroup A will be given kinesiology taping technique and exercise therapy whereas; patients in group B will be given compression decongestive therapy (manual lymphatic drainage, short stretch bandage and exercise therapy). All subjects will be assessed using assessment form, upper limb functional index, dynamometer, pinch meter and tape measure. Assessment will be conducted at base line, after 2 \& 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Age 30 to 65
* Patient undergoing Unilateral Modified Radical Mastectomy
* Within 1 week post Mastectomy
* Subjects without swelling or with mild swelling

Exclusion Criteria:

* active cancer or disease that might lead to swelling
* subjects taking anticoagulant therapy
* diagnose skin disease and skin allergies
* vascular insufficiency
* sensory impairments
* open wound and scars which have not healed
* Functional limitations of upper limb before mastectomy e.g. adhesive capsulitis.
Effect of High-calcium Intake on Substrate Metabolism During Exercise

A high-calcium intake can accelerate fat loss under energy-restricted diets. Part of this may be due to a shift in substrate metabolism where there is an increase in the rate of fat oxidation. However, whether high-calcium intake can influence substrate metabolism during exercise is not known. Accordingly, we aim to investigate the effect of 2 weeks of high-calcium intake on substrate metabolism during exercise.


Eligibility Criteria:
Inclusion Criteria:

* Physically active (moderate-vigorous exercise \>3 time per week)
* Male
* 18-40 yrs of age

Exclusion Criteria:

* Smoker
* Known Food Allergies
* Metabolic disorders
Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer

Multicenter open label, uncontrolled study that enrolled men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. The study was divided into Active and Long Term Follow-up (LTFU) Phases.

Multicenter open label, uncontrolled study that enrolled men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. The study was divided into Active and Long Term Follow-up (LTFU) Phases.

During the Active Phase eligible subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions. Subjects returned to the clinic for Week 6, Week 10, Month 6, and Month 12 visits. After the Month 12 visit, subjects were to enter the Long Term Follow-up Phase, in which they were contacted every 6 months via telephone.

Study Objectives:

Primary: Evaluate the immune response generated by sipuleucel-T.

Secondary: Evaluate the safety of sipuleucel-T and explore the correlation between sipuleucel-T immune response and overall survival.

Eligibility Criteria:
Inclusion Criteria:

* Previously randomized in Dendreon's P-11 study (NCT00779402) and received at least one infusion of sipuleucel-T
* Radiologic evidence of metastasis
* Castrate resistant prostate cancer. Subjects must have current or historical evidence of disease progression concomitant with surgical or medical castration, as demonstrated by PSA progression OR progression of measurable disease OR progression of non-measurable disease
* Castrate level of testosterone (\< 50 ng/dL) achieved via medical or surgical castration
* Adequate hematologic function

Exclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) performance status \> 2
* Treatment with chemotherapy within 3 months prior to registration
* Treatment with systemic corticosteroids, abiraterone acetate, external beam radiation therapy, or any investigational product for prostate cancer within 28 days prior to registration
* Treatment with commercial sipuleucel-T (Provenge®)
* Current or imminent pathologic long-bone fracture or spinal cord compression
* Known malignancies other than prostate cancer likely to require treatment within 6 months following registration
* A requirement for systemic immunosuppressive therapy for any reason
* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T or GM-CSF
* Any infection requiring antibiotic therapy or causing fever within 1 week prior to registration
* Any surgery requiring general anesthetic within 28 days prior to registration
The Therapeutic Role of Intravenous Albumin Administration for Peptic Ulcer Bleeding Patients With Hypoalbuminemia

To test whether intravenous albumin can decrease the rebleeding rate or shorten the duration of hospitalization in patients with peptic ulcer bleeding and hypoalbuminemia.

Peptic ulcer bleeding is a common but potentially lethal disease. Recurrent bleeding is an independent risk factor for mortality. Inhibition of gastric acid secretion by intravenous proton pump inhibitor infusion can have a positive impact on the prevention of ulcer rebleeding after successful endoscopic therapy. However, the rebleeding rate can still be high in patients with comorbid illnesses even after proton pump inhibitor usage. Hypoalbuminemia has been reported to be a significant predictor of poor prognosis in patients with comorbid illnesses. Low serum albumin levels are associated with poor prognosis of wound healing and peptic ulcer bleeding; therefore, it is worthy to conduct a head-to-head comparison to validate whether administration of albumin can be helpful in improving the control of bleeding peptic ulcers, especially in patients with comorbid illnesses.

The albumin level may reflect upstream pathologic processes, such as stress or co-morbidities. Albumin administration may interrupt the downstream chain of poor outcome and thus maintain a favorable homeostasis in critically ill patients, and reduce morbidity. However, the clinical benefit of controlling peptic ulcer bleeding with exogenous albumin remains uncertain, and thus administration of albumin is not widely applied. Accordingly, the investigators conducted this pilot intervention to test whether short-term exogenous albumin administration can improve the control of peptic ulcer bleeding in hypoalbuminemic patients, who are at high risk of recurrent bleeding.

Eligibility Criteria:
Inclusion Criteria:

* Clinical presentations of melena, hematochezia, or hematemesis
* Gastroscopy confirmed peptic ulcers and major stigmata of recent hemorrhage
* A Rockal score ≥ 6

Exclusion Criteria:

* Gastric or esophageal, or duodenal tumor bleeding
* Ulcer due to mechanical factors
* Warfarin use
* Failure to establish hemostasis under gastroscopy
* Hypersensitivity to omeprazole, esomeprazole, albumin or any component of the formulation.
Identification and Verification of Neutrophil Extracellular Trap Net Related Markers in Acute-on-chronic Liver Failure

Acute-on-chronic liver failure (ACLF) refers to the acute deterioration of liver function in patients with chronic liver disease. Neutrophils are a major component of the innate immune system, and previous studies have revealed enhanced production of neutrophil extracellular traps (NETs) in ACLF. However, there is still a lack of systematic research on the correlation between NETs and the prognosis of ACLF. We screened NETs related biomarkers through bioinformatics analysis, which play an important role in the diagnosis of ACLF. This study will explore whether these NETs related biomarkers also play an important role in the prognosis of ACLF and further investigate their role in the pathogenesis of ACLF.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who meet the diagnostic criteria of Chinese Group on the Study of Severe Hepatitis B (COSSH) for acute-on-chronic liver failure

Exclusion Criteria:

1. Age greater than 75 years old
2. liver cancer
3. previous liver transplantation
4. other serious extrahepatic organ diseases
5. uncontrolled bacterial infections.
Patient Acceptance And Satisfaction of Teledermoscopy In General Practice In a Belgian Rural Area

The aim objective of this work is to assess the characteristics of patients for whom teledermoscopy could be suitable for the detection of potential skin cancers, within a population of rural general medicine in the South of Hainaut, by means of a mixed quantitative and qualitative study corresponding respectively:

* To identify patients' knowledge of skin cancers, their skin monitoring habits, and their acceptability of new telemedicine tools such as teledermoscopy ("Part 1").
* To evaluate the satisfaction and expectations of those who benefit from teledermoscopy ("Part 2").


Eligibility Criteria:
Inclusion Criteria:

* Adults ( \> 18y)
* French Speaking Patient

Exclusion Criteria:

* Illiterate Patients
* Demented Patients
* Non-French speaking patients
* Minors.
Jordan Diabetes Microclinic Project

The purpose of the study is to provide participants in economically depressed areas of Jordan essential knowledge, practical skills, and intimate support groups-called microclinics-for managing their diabetes. Microclinics consist of 2-8 individuals from pre-existing social networks (friends, relatives, coworkers, neighbors, etc) that voluntarily participate in ongoing education and medical monitoring from local health care professionals, learning and practicing diabetes management strategies, sharing much-needed medical supplies, and exchanging social support in the form of regular micro-clinic meetings.

The Global Microclinic Project seeks to empower people to prevent and manage diseases in economically depressed areas Jordan. The project seeks to more broadly link health education opportunities in the form of lectures and seminars with practical experience through workshops and hands-on learning, ultimately resulting in the creation of microclinics. Microclinics are intimate support groups of diabetic patients (2-8 per clinic) who meet in their homes and businesses in order to share the costs of maintaining medical monitoring equipment and supplies, come together to support one another in the management of diabetes, collectively utilize vital treatment options, and receive personalized screening, education and management tools from medical professionals.

The microclinics concept is ideal for the management of chronic disorders such as diabetes, a disease which requires ongoing education about diet and exercise and regular monitoring of health indices such as blood glucose levels and weight change. Indeed, the microclinics model has been established successfully in the West Bank specifically to combat diabetes. The goal here is to extend the model to Jordan and to establish microclinics in a collaborative effort with the Royal Health Awareness Society (RHAS) and the Jordanian Ministry of Health (MoH).

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Mentally competent
* Have diabetes or pre-diabetes or brought a family member who was diabetic/pre-diabetic (Diabetes: Fasting blood glucose higher than 125 mg/dl; Pre-diabetes: Fasting blood glucose between 100 and 124 mg/dl.)

Exclusion Criteria:

* They do not meet the above criteria
* They are pregnant
* They have significant medical complications that prevent them from making changes to diet or level of physical activity.
Budesonide Versus Placebo for the Treatment of Lymphocytic Colitis

Patients will receive budesonide or placebo for the treatment of active lymphocytic colitis. This study includes stool collections, blood draws, weekly questionnaires and a sigmoidoscopy. The study hypothesis is that budesonide will be safe and effective compared with placebo for the treatment of diarrhea in lymphocytic colitis.

Microscopic colitis is an increasingly diagnosed cause of chronic diarrhea, with two main subtypes: collagenous and lymphocytic colitis. Uncontrolled reports have suggested that various drugs can be beneficial in treating microscopic colitis, but few treatments have been evaluated in randomized controlled trials. Thus, treatment is guided mostly by anecdotal reports, case series, and physicians' experience. In our uncontrolled experience, corticosteroids are one of the most effective therapies for microscopic colitis, but are not typically used as a first line therapy because of toxicity. Budesonide has been reported to be of clinical benefit in small, uncontrolled series of patients with microscopic colitis, and recent controlled trials showed that it is superior to placebo in collagenous colitis. We propose a study of budesonide in patients with the lymphocytic type of microscopic colitis.

Patients will have stool specimen and blood drawn at the start of the study. Patient will take either Budesonide or placebo for 8 weeks. At the end of treatment, patient will have stool collection and sigmoidoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Diarrhea, defined as greater than 4 bowel movements per day and greater than "mild"; currently on no treatment or active despite treatment.
* Lymphocytic colitis confirmed histologically within one year of enrollment

Exclusion Criteria:

* Previous unsuccessful treatment with corticosteroids or immunosuppressive drugs
* History of severe corticosteroid side effects
* Corticosteroid, ticlopidine, or flutamide use within the previous 4 weeks
* Antibiotic, mesalamine or bismuth subsalicylate use within two weeks
* Current use of anticholinergics, cholestyramine, narcotics, ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, or grapefruit juice
* Known active medical conditions, including cancer, infection, uncontrolled hypertension or diabetes, osteoporosis, peptic ulcer disease, glaucoma, cataracts, liver cirrhosis or history of tuberculosis
* Other diarrheal conditions (sprue, infection, hyperthyroidism, lactose intolerance)
* Pregnant or nursing females
* Patients without a telephone or unable to communicate in English over the telephone, or unable or unwilling to give consent
* Known hypersensitivity to or intolerance of budesonide.
Study Describing the Coverage, Cares and the Fertility of Patients of Less Than 45 Years With a Borderline Ovarian Tumor

Retrospective and prospective multi-center study

Indication: Fertility-sparing surgery for patients with borderline ovarian tumor and fertility

Objectives:

* Description of the characteristics of the patients of less than 45 years having a fertility-sparing surgery for borderline ovarian tumors, the modalities of care and their fertility.
* Validation of a nomogram as an information medium to the patients concerned on their chance of alive birth according to their personal characteristics

Origin and nature of the specific data:

* Extraction from the database " Tumeurs Malignes Rares de l'Ovaire " (TMRO)
* Collection of retrospective further informations in the participating centers
* Data collection from the patients (questionnaires) The data will be identified by the TMRO number allocated to every participant of the TMRO study .

Data traffic :

TMRO database extraction for the patients with BOT and corresponding to the inclusion criteria, supplied by Arcagy-Gineco.

The database will be managed by the coordination team in an anonymous way by means of the patient identifiers of the TMRO base.

Enrichment of the base by the anonymous questionnaires filled by the patients and the complementary data transmissions of the centers on anonymised files.


Eligibility Criteria:
Inclusion Criteria:

* Women with history of Borderline Ovarian Tumor (BOT).
* Women who have had first a fertility-sparing surgery.
* Women old enough to procreate (= 45 years) during their first surgery.
* Women having agreed to participate in the previous study "Observatoire sur les Tumeurs Malignes Rares de l'Ovaire" (TMRO).
* Women who have not expressed their opposition to the research.

Exclusion Criteria:

* The patients who are not corresponding to the selection criteria are straightaway excluded from the retrospective database selected for the study (TMRO).