cyrilzakka/clinical-trials huggingface dataset:
Two Cancers, One Gene. Why Some People in Families Develop Melanoma or Pancreas Cancer, While Still Others Never Develop Cancer.

Individuals who are affected with pancreas cancer and melanoma as well as those without either cancer who have been identified as 1st or 2nd degree relatives of family members with pancreas cancer and melanoma will be asked to participate. The participant will be asked to complete a survey about their health and family history of cancer and to give a blood sample for specific gene testing and storage for future research studies.The overall goal of this study is to understand the factors that increase susceptibility and expression of pancreatic cancer and melanoma in high risk families.


Eligibility Criteria:
Inclusion Criteria:

* Individuals who are affected with pancreas cancer and melanoma as well as those without either cancer who have been identified as 1st or 2nd degree relatives of family members with pancreas cancer and melanoma.

Exclusion Criteria:

* Under the age of 18, Non-English speaking or unable to provide informed consent, inmates.
Effectiveness of Automated Inpatient Endocrinology Consultation for Osteoporotic Hip Fracture

Osteoporosis has been called a "silent epidemic" whose prevalence is increasing. It often presents as a fragility fracture, with hospitalizations resulting from minimally traumatic hip fractures. While the fractures are treated appropriately, the underlying pathology is often ignored. Numerous studies have shown that prior fracture increases the risk for further fracture. In 2004 the Surgeon General released a report on osteoporosis, the details of which include multi-disciplinary treatment of osteoporotic fractures. Treatment of osteoporosis after hip fracture is also being targeted as a future hospital quality assessment measure. Hospitals which have no plan in place to address osteoporosis treatment after hip fracture may be cited, and may have medicare money withheld. The goal of the study is to create an automated in-patient endocrinology consultation for osteoporotic hip fractures. We plan to gather patient data in a prospective manner including the endocrinologist recommendations, adherence to medical therapy after discharge, and future fracture rates. Possible planned interventions include only appropriate medical therapy for osteoporosis, DEXA bone scanning, and regularly scheduled telephone follow-up.


Eligibility Criteria:
Inclusion:

1. over 55
2. non-traumatic hip fracture

Exclusion criteria:

1. currently on anti-osteoporosis pharmacotherapy including bisphosphonates, PTH, and calcitonin
2. high energy nature of fracture, including MVA, fall from height greater than 3 feet
3. severe dementia, lack of capacity
Self-Directed Online Training for Chinese Caregivers

The proposed project seeks to develop an online self-directed learning (SDL) intervention program that seeks to improve caregiving and self-care skills among ethnic Chinese dementia caregivers. The benefits of such a product may include improved psychological health in caregivers and a reduction in behavioral disturbances among elderly care recipients with dementia.

The objective of this Phase II application is to develop an online self-directed learning (SDL) intervention program that seeks to improve caregiving and self-care skills among ethnic Chinese dementia caregivers. The benefits of such a product may include improved psychological health in caregivers and a reduction in behavioral disturbances among elderly care recipients with dementia. While online dementia caregiver interventions are advantageous in reaching broad audiences, these individuals face significant challenges in engaging the target audience and keeping them engaged throughout the intervention program. The proposed online SDL skill training intervention addresses these challenges with a comprehensive engagement design to ensure retention and effective learning in the training program.

All Phase I Study Aims have been successfully completed. The prototype provides preliminary evidence that an SDL training intervention is able to successfully engage ethnic Chinese caregivers of elders with dementia, improving perceived self-efficacy to manage caregiving tasks, while reducing negative emotions in the caregiver. Phase II Specific Aims: The Phase II study will further develop the prototype into a fully-functioning online SDL skill training intervention for ethnic Chinese dementia caregivers, and evaluate it in a randomized control trial. In Specific Aim 1, the research team will develop additional multi-lingual training video clips to complete the training program, and make them available for Cantonese-, Mandarin-, and/or English-speaking caregivers from different Chinese cultural backgrounds. In Specific Aim 2, the research team will develop software that enables and integrates all engagement design functionalities. In Specific Aim 3, the research team will conduct a randomized controlled trial to evaluate the effectiveness of the SDL training intervention based on a comprehensive engagement design (intervention arm) compared to one that does not rely on a comprehensive engagement design (control arm).

Evidence of the effectiveness of the SDL intervention will contribute to the larger information and communication technology field, increasing the public's understanding and basic knowledge of effective engagement in the rapidly growing field of online health interventions. The comprehensive engagement approach developed through this research could be transferred to other ethnic minority groups facing dementia caregiving challenges, as well as other populations facing challenges related to the management of other chronic conditions.

Eligibility Criteria:
Inclusion Criteria:

* Ethnic Chinese Caregiver

Exclusion Criteria:

* Not Chinese or Caregiver
A Safety and Efficacy Study of LymphoStat-B™ (Monoclonal Anti-BLyS Antibody) in Subjects With Rheumatoid Arthritis (RA)

The purpose of this study is to evaluate the safety and efficacy of 3 different doses of belimumab, administered in addition to standard therapy, in patients with rheumatoid arthritis (RA).

The purpose of this study is to evaluate the safety and efficacy of three different doses of belimumab (1 mg/kg, 4 mg/kg, and 10 mg/kg), administered in addition to standard therapy, compared to placebo plus standard therapy in patients with RA. All patients were to be dosed on Days 0, 14, and 28, then every 28 days for the remainder of 24 weeks. Patients completing the 24-week period could enter a 24-week open-label extension; belimumab patients received the same dose or were switched to 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg.

Eligibility Criteria:
Primary Inclusion Criteria:

* Diagnosis of RA for at least 1 year
* Failed at least 1 disease modifying anti-rheumatic drug (DMARD) due to toxicity or lack of efficacy. These drugs must include 1 or more of the following: methotrexate, parenteral gold, sulfasalazine, leflunomide, and tumor necrosis factor-alpha (TNFα) inhibitors (infliximab, etanercept or adalimumab)
* Active RA disease of at least moderate disease activity
* Be on a stable RA treatment regimen for at least the past 60 days (for DMARDS); if on non-steroidal anti-inflammatory drugs (NSAIDs) or steroids these must be at a stable dose for the last 30 days

Primary Exclusion Criteria:

* Received a non-FDA approved investigational agent within the last 28 days
* Currently receiving or received within the last 60 days the following: TNFα-inhibitors (infliximab, etanercept, adalimumab) or interleukin-1 receptor antagonist (anakinra)
* Currently receiving or received within the last 6 months the following: anti-CD20 antibody (rituximab) or cyclophosphamide
* Steroid injection into any joint within the last 30 days
* History of hypogammaglobulinemia or immunoglobulin A (IgA) deficiency
* History of chronic infection that has been active within last 6 months, or herpes zoster within last 90 days, or any infection requiring hospitalization or intravenous medication within last 60 days
* Human immunodeficiency virus (HIV), Hepatitis-B, Hepatitis-C
Mucosal Barrier Defects in Functional Dyspepsia by Confocal Laser Endomicroscopy

There has been recent interest into the potential role of mucosal barrier defects in the pathophysiology of functional gastrointestinal disorders (FGIDs). There has been evidence of increased intestinal permeability in patients of IBS,and abnormal tissue resistance in NERD. Although the mucosa of Functional dyspepsia (FD) patients is endoscopically and histologically "normal," it contains ultrastructural changes, activated immune cells, along with evidence of an increased release of mediators leading to gastric dysfunction. There is now consistent evidence indicating that mucosal barrier defects allow the passage of an increased load of bacteria, antigens and toxins which, in turn evoke activation of mucosal immune responses involved in the FD symptom.

Confocal laser endomicrosopy is a newly developed device which allows in vivo and real time observation of gastrointestinal mucosa.In our pilot study we found that the contrast agent fluorescein sodium shew differences of leakage into intercellular spaces and crypt lumen among different patients of FD.

This study is aimed to determine if there is microscopic changes detectable in the gastric mucosal epithelium through confocal endomicroscopy of FD patients, and to evaluate the relationship among minimal changes(transmission electron microscopy and Confocal laser endomicrosopy ), FD symptoms(symptom index form) , neuropeptides and immune responses(immunohistochemistry).

Eligibility Criteria:
Inclusion Criteria:

* patients meeting IBS diagnosis criteria and indications for endoscopy investigation.
* Asymptomatic individuals for health surveillance or patients for follow up after polypectomy.

Exclusion Criteria:

* Esophageal, gastric or duodenal cancer or other malignancy
* History of esophagus, stomach, or duodenum surgery
* Conditions that preclude safe biopsies (coagulopathy, haemophilia, esophageal varices,and patients on warfarin and antiplatelets)
* A history of bronchial asthma, or known allergy to fluorescein
* Pregnant or breast-feeding (for females)
* Below 18 or above 75 years of age
* Severe co-morbidities
* Unable or unwilling to give informed consent
Docetaxel 2-weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer

A Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety of a Single Agent Docetaxel 2-Weeks Regimen in the Treatment of HER2 Negative Metastatic Breast Cancer to a 3-Weeks Regimen

Docetaxel 2-Weeks Regimen:Docetaxel 50mg/m2 Docetaxel 3-Weeks Regimen:Docetaxel 75mg/m2

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* The age is Above 18 years of age, \<70 years old
* The diagnosis of breast cancer was confirmed by cytological examination or pathological examination. HER2-negative
* Clinical stage was metastatic breast cancer or locally advanced breast cancer.
* Must have at least one measurable lesion, according to RECISTv1.1.
* Eastern Cooperative Oncology Group performance status (ECOG PS)=0\~2
* Docetaxel or paclitaxel can been used in initial treatment or in the past for locally advanced, recurrent or metastatic lesions,if used must been proved effective, and recent progress over 6 months.
* The basic function of normal bone marrow
* Functions of liver and kidney is normal
* Expectation of life is more than 3 months
* Agreed to take contraceptive measures during treatment

Exclusion Criteria:

* The patient had a history of allergy to taxanes or their components.
* Recent progress of taxanes in 6 months.
* In the elution period of other chemotherapy regimens.
* Severe coagulopathy.
* HER2 positive breast cancer
* Previous toxicity was not recovered to 0-1 degrees
* Central nervous system metastasis had not Controlled yet
* Pregnancy or lactation
* There are uncontrolled infection, myocardial infarction, thrombosis, etc.
* There are uncontrolled chronic diseases such as diabetes, hypertension, peptic ulcer, chronic hepatitis, mental disease;
* HIV infection
* Patients with other malignant tumor history, except the healed skin basal cell carcinoma and carcinoma of uterine cervix;
* Researchers believe that is not suitable for the study
68Ga-HA-DOTATATE Imaging of Suspected Somatostatin Receptor Positive Tumors

Somatostatin receptor (SSR) imaging is a critical component of clinical care for many patients being investigated for or with confirmed SSR positive tumors. In the past, 111In-octreotide imaging has been used for this purpose but it has been recently supplanted globally by SSR positron emission tomography (PET) imaging due to better image quality and higher diagnostic accuracy.

This study will assess the safety and diagnostic effectiveness of 68Ga-HA-DOTATATE produced a the Edmonton Radiopharmaceutical Centre (ERC).

A single centre non-randomized, non-blinded phase II prospective cohort study evaluating the safety and efficacy of 68Ga-HA-DOTATATE PET/CT imaging in patients with known or suspected somatostatin receptor positive tumors.

Up to 600 scans will be included over 6 years. All patient ages (pediatric and adult) will be included. Individual patients may have more than one scan during the study period.

Safety evaluation will consist of an adverse event assessment whil in the Nuclear Medicine department at the University of Alberta Hospital. Efficacy evaluation will consist of a comparison to CT and/or MRI accuracy based on 1 year follow-up clinical evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with known or clinically suspected somatostatin receptor positive tumors including but not limited to: gastrointestinal neuroendocrine tumors, pancreatic neuroendocrine tumors, pulmonary neuroendocrine tumors, neuroendocrine tumors - primary unknown, pheochromocytoma, paraganglioma, medullary thyroid cancer, medulloblastoma, meningioma
* A standard clinical CT or MRI is obtained within 6 months of enrollment
* Ability to provide written informed consent prior to participation in the study (participant or if required a legal medical decision maker)

Exclusion Criteria:

* Weight \> 225 kg (weight limit of the PET/CT scanner)
* Inability to scan (ie. extreme claustrophobia) or inability to lie still for imaging
* Any additional medical condition, serious inter-current illness, or other extenuating circumstance that, in the opinion of the investigator or attending department physician, may significantly interfere with study performance or interpretation
* Previous allergic reaction to DOTATATE or somatostatin analogues
* Lack of intravenous access
Study of the Nervous Control of the Anal Sphincter

Anal incontinence and constipation are frequently observed in patients with neurological disease. The purpose of this study is to evaluate the neurological control of the anal sphincter in healthy subjects, patients with neurological disease by a new electrophysiological technique. This technique consists in recordings of anal sphincter responses after magnetic stimulations of the cortex and the sacral nerves.


Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* patients with spinal lesion
* patients with cauda equina syndrome

Exclusion Criteria:

* pregnant women
* pacemaker or other metallic material implanted
* epileptic patients
* organic colorectal disease
* obese patients
* previous neurological surgery
Wearability, Saefty and Usability Assessment for the Upper Limb Exoskeleton BRIDGE/EMPATIA

The study is a feasibility study or pilot study, that is a clinical investigation to acquire the preliminary information on a motorized exoskeleton (BRIDGE / EMPATIA exoskeleton) for the movement of the upper limb in order to develop it, including design changes. The primary objective of the clinical trial is to assess the fit, safety and usability of the device in supporting the execution of daily activities for patients suffering from muscular dystrophy. The risk analysis for the BRIDGE / EMPATIA device does not present particular criticalities that preclude the use of the device in the target population. In any case, during the trial eventual adverse events are recorded for the verification of safety..


Eligibility Criteria:
Inclusion criteria:

1. Availability of the patient and/or caregiver at the signing of the informed consent for participation in a clinical trial study protocol
2. Defined diagnosis of Muscular Dystrophy (Duchenne, Becker, Cingoli type 2 and facio-scapulo-humeral). Biopsy will not be performed except in cases where a diagnostic need arises.
3. Wheelchair bounded
4. Significant weakness in the muscular districts of the shoulder girdle and the proximal upper limb portion detected by the MRC scale (between 0 and 2)
5. Cognitive skills that allow the understanding and management of the device
6. Arm length measured from the shoulder to the elbow between 26.5 cm and 28.7 cm; forearm length, measured between elbow and wrist, maximum 22.4 cm

Exclusion criteria:

1. Presence of important comorbidities (epilepsy, dependence 24/24 hours from non-invasive and invasive ventilation)
2. Behavioral and psychiatric disorders (e.g., emotional problems, depression)
3. Inability to maintain a sitting position in a wheelchair
Contrast-Enhanced Ultrasound Imaging in Diagnosing Liver Cancer in Patients With Cirrhosis

This clinical trial studies how well contrast-enhanced ultrasound imaging works in diagnosing liver cancer in patients with cirrhosis. Diagnostic procedures, such as contrast-enhanced ultrasound imaging, may help find and diagnose liver cancer.

PRIMARY OBJECTIVES:

I. To evaluate the sensitivity, specificity, positive and negative predictive values of contrast-enhanced ultrasound (CEUS) for diagnosis of hepatocellular carcinoma (HCC) in patients at risk for HCC in a multicenter setting.

SECONDARY OBJECTIVES:

I. To validate CEUS Liver Imaging Reporting and Data System (LI-RADS) and determine the prevalence of HCC in each CEUS LI-RADS category.

II. To evaluate inter-reader reliability of CEUS for HCC diagnosis. III. To evaluate covariates that might limit diagnostic performance of CEUS for HCC diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Capable of making informed decisions regarding his/her treatment
* Have known cirrhosis or other risk factors for HCC, based on American Association for the Study of Liver Diseases (AASLD) and European Association for the Study of the Liver (EASL) guidelines (applicable in each site jurisdictions)
* Patients with untreated focal liver observations on liver ultrasound or multiphase contrast-enhanced CT or MRI performed as part of clinical standard of care within 4 weeks before patient enrollment.

OR

• Patients with untreated focal liver observations scheduled for follow-up multiphase contrast-enhanced CT or MRI, biopsy or surgical excision as part of clinical standard of care. CEUS should be performed within 4 weeks before or after follow-up imaging or within 4 weeks before biopsy or surgical excision.

Exclusion Criteria:

* Patients who are pregnant or lactating
* Patients with focal liver observations less than 5 mm or greater than 5 cm in size
* Patients with contraindications to CEUS
* Patients with contraindications to both CT and MRI
* Patients who are medically unstable, terminally ill, or whose clinical course is unpredictable
* Liver nodule previously treated with trans-arterial or thermal ablation
* Patients who have received an investigational drug in the 30 days before CEUS, or will receive one within 72 hour after their CEUS exam
Synergistic Effect of Vitamin D Supplementation in Patients With Vitiligo and Vitamin D Deficiency

This prospective, randomized, controlled study was approved by the Institutional Review Board of Hallym University Kangnam Sacred Heart Hospital (IRB no. 2018-04-017). All study participants consented the study and agreed the written informed consent. All participants who are applicable to the inclusion criteria were randomly assigned to two groups: the control group and the study group. Both groups were treated with phototherapy including 308-nm excimer laser or narrowband ultraviolet B (NB-UVB). Study group had vitamin D supplementation through the injection additionally.


Eligibility Criteria:
Inclusion Criteria:

1. patients diagnosed with non-segmental vitiligo based on clinical diagnosis.
2. patients who were ≥ 18 years old.
3. patients with lower serum vitamin D level (\<20ng/mL).

Exclusion Criteria:

1. patients taking medicines such as thiazide, diuretics, lithium which can influence the serum vitamin D level.
2. pregnant or lactating women.
3. patients with diseases which can affect kidney such as chronic kidney disease, hyperparathyroidism, or hypoparathyroidism.
4. patients with uncontrolled chronic diseases like diabetes mellitus, hyperlipidemia, hypertension
5. patients whose spot urine calcium level was over 30mg/dL.
Intervention to Support the Reintegration of Former Combatants and Soldiers

The project aims to investigate if trauma-related disorders and appetitive aggression can be reduced in former ex-combatants in DR Congo when a specific intervention (Narrative Exposure Therapy for Forensic Offender Rehabilitation, FORNET) is delivered by trained local personnel (phase 1). In a second step, the project aims to investigates the treatment success if this specific therapy is carried out by local personnel who have been trained by other local personnel ("train the trainer", phase 2) under the supervision of experts of the University of Konstanz.

The reintegration of former child soldiers and ex-combatants is a big challenge in war-torn countries. Former child soldiers and ex-combatants often suffer from mental health problems and show enhanced levels of aggression. The present study focuses on the reduction of appetitive aggression and the improvement of mental health in former child soldiers and ex-combatants in DR Congo.

The project consists of four steps:

1. Training of selected DDRRR personnel(first generation)in FORNET (a variant of Narrative Exposure Therapy to treat trauma-related disorders and to reduce appetitive aggression)by experts from the University of Konstanz.
2. Treatment phase 1: Intervention will be carried out by therapists of the first generation. The trained therapists of the first generation will be supervised from the experts of the University of Konstanz.
3. Training of a second generation of DDRRR personnel in FORNET by the therapists of the first generation.
4. Treatment phase 2: Intervention will be carried out by therapists of the second generation. The trained therapists of the second generation will be supervised from the therapists of the first generation.

The study is conceived as a randomized controlled study. In phase 1 and in phase 2, study participants will be randomized allocated to the intervention group (FORNET) and the control group (no intervention). The treatment effect will be measured by pre-post and 6-months follow-up evaluations.

Eligibility Criteria:
Inclusion Criteria:

* Ex-combatants who live in a transit camp in Goma, Congo.

Exclusion Criteria: