cyrilzakka/clinical-trials huggingface dataset:
Web-Based Program for Symptom Management in Fibromyalgia

Fibromyalgia is a complex chronic illness affecting 6-12 million Americans. Self-management strategies play a key role in reducing symptoms and maintaining functioning. The proposed project offers a web-based self management tool that enables FM sufferers to identify significant linkages between their personal symptom levels and their personal self-management efforts over time in order to plan their own optimal approach to disease management.

This Phase II project will complete development of the SMART (Self-Monitoring and Review Tool) Log program for symptom management and health promotion in FM and evaluate its efficacy in a large web-based trial that will closely emulate its planned application in Phase III. The SMARTLog program is an interactive web-based self-monitoring and feedback intervention that employs proprietary statistical analysis procedures to give the user personally optimized guidance on behavioral, lifestyle and coping strategies that yield effective symptom reduction for that individual. The program incorporates longitudinal collection and analysis of the individual's self-monitoring data followed by delivery of personalized feedback derived from those same personal data. The program helps FM sufferers discover and monitor linkages between specific personal health-related behaviors and management strategies and their symptom levels over time. Feasibility was demonstrated in Phase I by very high retention rates, ratings of satisfaction and perceived relevance, evidence of impact of utilization on improved well-being over the use period, and qualitative data indicating strong interest in continuation with the program.

Eligibility Criteria:
Inclusion Criteria:

* Self-reported presence of fibromyalgia

Exclusion Criteria:

* None
Effectiveness of Point of Care Blood Analysis Obtained From Skin Puncture Blood

This study aimed to evaluate the correlation between the point of care blood analysis obtained from skin puncture blood and conventional blood analysis obtained from venous and arterial blood.


Eligibility Criteria:
Inclusion Criteria:

* The patients who simultaneously require the venous blood test, skin puncture blood test and arterial blood gas analysis

Exclusion Criteria:

* Unstable patients
* Patients receiving the medications affecting the results of blood analysis.
Intra-arterial Versus Intravenous Chemotherapy for Locally Advanced Pancreatic Cancer

This study aims to explore the efficacy and safety of intra- arterial infusion of gemcitabine and oxaliplatin in locally advanced pancreatic cancer. This protocol is overseen by the Fudan University Institutional Review Board which has Federal Wide Assurance through the U.S. Department of Health \& Human Services (Approved: April 25, 2002).

Primary Outcome Measures:

To compare the overall survival (OS) in patients with locally advanced pancreatic cancer treated with transcatheter arterial infusion (TAI) of chemotherapeutics or systemic delivered chemotherapy.

Secondary Outcome Measures:

To compare the progression free survival (PFS), objective response rate (ORR), quality of life (QoL), and adverse effects of treating locally advanced pancreatic cancer patients with TAI or systemic chemotherapy.

Exploratory Outcome Measures:

To evaluate the correlation between prognosis and expression of serum microRNAs of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Histologically/cytologically confirmed unresectable locally advanced pancreatic adenocarcinoma.
* Measurable disease by RECIST criteria must be present.
* Karnofsky Performance Status ≥ 70
* Patients with adequate organ functions reflected by the laboratory criteria below:

Granulocytes ≥ 1,500/uL Hemoglobin ≥ 8.0 gm/dL Platelets ≥ 100,000/uL Serum creatinine \< 2.0 mg/dL Bilirubin \< 1.5 mg/dL SGPT \< 2.5 x normal Alk Phos \< 2.5 x normal

* Prior local therapy, e.g., radiation, is allowed provided that at least 4 weeks washout time is given.
* Patients with jaundice must have a biliary drainage decompression operation before recruitment.
* Patients must not be pregnant. Serum beta-HCG will be checked in all premenopausal patients.
* Ability to understand and the willingness to sign a written informed consent.

Exclusion Criteria:

* Subject with metastatic disease.
* Prior treatment with systemic chemotherapy.
* Known allergies to the gemcitabine, oxaliplatin or iodine contrast agent.
* Subject with Child-Pugh grade Class C hepatic impairment, active gastrointestinal bleeding, severe coagulation disorder that could not be corrected，or other contraindication for transcatheter infusion.
* Untreated or uncontrolled deep vein thrombosis, arterial thrombosis of lower extremity, or aneurysm.
* Concurrent infection requiring intravenous antibiotics.
* Skin injury or infection of groin area, or other situation that not appropriate for femoral artery puncture.
* Other serious illness or condition including cardiac disease including congestive heart failure (New York Heart Association Classification III or IV), active HIV infection/HIV disease, psychiatric disorders.
* Known central nervous system involvement and leptomeningeal disease
* Subject with previous or concurrent cancer that is distinct in primary site or histology from pancreatic adenocarcinoma except cervical carcinoma in situ, non-melanoma carcinoma of the skin or in situ carcinoma of the bladder. Any cancer curatively treated greater than 3 years prior to entry is permitted.
* Pregnant or lactating women.
Brilliant Blue Versus Indocyanine Green

A study of non-inferiority design comparing brilliant blue and indocyanine green as intraoperative dye in macular pucker and macular hole.


Eligibility Criteria:
Inclusion Criteria:

* age over 50
* macular pucker or macular hole with subjective disturbances
* All phakic or pseudophakic patients
* far visual acuity better than 20/400
* able to read, understand, and willing to sign the informed consent form

Exclusion Criteria:

* any other ocular disease or conditions compromising the visual acuity other than macular hole or macular pucker
* prior vitreoretinal surgery in the study eye
The Effects of Transcranial Direct Current Stimulation on Central Pain in Patients With Spinal Cord Injury

The purpose of this study is to evaluate the analgesic effect of transcranial direct current stimulation (tDCS) applied on motor cortex in patients with spinal cord injury who have chronic neuropathic pain.

* anodal stimulation of the primary motor cortex (M1)
* anode electrode: C3 (EEG 10/20 system)
* cathode electrode: contralateral supraorbital area
* constant current of 2mA intensity for 20 min
* twice a day with a more than 4 hours interval during of 2 weeks (from Monday to Friday, total 20 treatment session)

Eligibility Criteria:
Inclusion Criteria:

* elapsed time since spinal cord injury more than 6 months
* stable chronic pain for at least 3 preceding months
* pain that was not attributable to cause other that neuropathic pain
* pain that was resistant to various types of medications or physical or complementary medicine treatment

Exclusion Criteria:

* any kind of metal implant in the head
* heart disease including having a cardiac maker
* family or personal history of epilepsy, or neuropsychiatric illness
Nasal Endoscopic Screening and Risk Assessment for Early Gastric Cancer

Pepsinogens (PGs) can be used for gastric cancer (GC) screening, but the cutoff levels vary among studies, and PG levels are influenced by numerous factors. To examine the diagnostic value of PG levels and Helicobacter pylori (Hp) status for GC and precancerous lesions screening in asymptomatic individuals undergoing health checkup in China.

Pepsinogens (PGs) can be used for gastric cancer (GC) screening, but the cutoff levels vary among studies, and PG levels are influenced by numerous factors. To examine the diagnostic value of PG levels and Helicobacter pylori (Hp) status for GC and precancerous lesions screening in asymptomatic individuals undergoing health checkup in China. We operated a multicenter cross-sectional study of subjects who underwent health checkup at nine International Healthcare Centers in China. All participants underwent gastroscopy and pathological examination, serum PG, 13C-urea breath test, and/or Hp serological current infection marker rapid test, all on the same day. PG related parameters were analyzed in different Hp subgroups and regions.

Eligibility Criteria:
Inclusion Criteria:

intention to undergo gastroscopy during health checkup examination 25-75 years of age.

Exclusion Criteria:

a history of gastric ulcer, gastric polyp, or GC a history of gastrectomy treatment with a proton pump inhibitor in the last month contraindications to gastroscopy a history of Hp eradication a history of abdominal pain, abdominal distention, belching, acid reflux, nausea and other digestive tract symptoms within 1 month incomplete data.
Group Based Treatment for Persons With Social Communication Difficulties

A large proportion of patients with ABI have cognitive deficits that affect the way they communicate. Cognitive difficulties with attention, memory, executive functions and so on affect social communication. Without successful social skills, a person may engage in conflicts, become isolated and be denied access to social and vocational opportunities. Internationally, several group interventions have been developed for treating social communication difficulties during the last years.

Group Interactive Structured Treatment (GIST) is a validated holistic multidisciplinary group treatment targeting social communication skills after traumatic brain injury. The main aim of the present study is to examine the efficacy of GIST for improving social communication in persons with acquired brain injury, including TBI, stroke, tumor ect. Secondary the study aims to compare the standard GIST protocol to an newly developed intensive GIST protocol. Efficacy will be assessed immediately after intervention, but also three and six months after the intervention. The project is in line with international research efforts aimed to establish more knowledge about group treatment for persons with social communication disorders after ABI.


Eligibility Criteria:
Inclusion Criteria:

* traumatic brain injury (TBI), cerebrovascular accidents (stroke; CVA) patients with no concomitant diseases minimum 6 months post-injury
* The patient are experiencing social communication disorders
* The family member is experiencing the patients social communication disorders
* The patient is motivated and expresses a desire to change communication behavior
* One close family member is able to participate in the intervention process
* Adequate Norwegian language proficiency to participate in the group
* The patient experiences moderate to severe difficulties with minimum 3 aspects of communication assessed with La Trobe Questionnaire
* The patient have insight into their communication difficulties (minimum intellectual insight) assessed with Awareness Questionnaire

Exclusion Criteria:

* Age \<18 years
* Aphasia. Based on previous records.
* Major psychiatric disorder or reported ongoing alcohol or substance abuse
* Premorbid neurological disease or insult and/or comorbid neurological disease
* Impaired basic linguistic, mnemonic, motor, or perceptual function that can interfere with the ability to engage with the training or intelligence quotient (IQ) \< 85
Bringing of PET-TDM FDG in the Determination of the Characteristics of Primary Mammary Tumors TrIple Negatives

"Triple Negative" breast cancers are a heterogeneous group characterized by the absence of hormone receptors to estrogen, progesterone and the absence of expression or amplification of the HER-2 gene. This type of cancer is associated with an adverse clinical profile with a high risk of early metastatic relapse. Accurate identification of prognostic factors, as well as predictors of therapeutic response, and the contribution of targeted therapies are avenues for improving the management and survival of patients with these cancers. Such an approach requires optimal biological characterization, allowing us to understand the complexity of this group of tumors, and requires multidisciplinary collaboration in clinical trials involving anatomopathology, oncology and morpho-functional imaging.

The investigator's goal is to characterize by innovative methods (anatomo-pathological in particular Of Immunohistochemistry, and morpho-functional imaging (TEP-TDM FDG) semi-quantitative and texture) in a population of Triple Negative Breast Cancer scans better knowledge of this entity that can lead to the development of relevant therapeutic strategies and especially more adapted in the context of precision and personalized medicine.

120 consecutive patients with "Triple Negative" breast cancers operatable from the outset will be included in the study

* To assess the prognostic value of the texture parameters of PET-TDM FDG on event-free survival at 2 years.
* To assess the prognostic value of standard parameters (clinical, standard histology, conventional imaging), semi-quantitative PET-TDM FDG and innovative Immuno-histochemistry parameters for 2-year event-free survival .
* To assess correlations between continuous PET-TDM FDG texture parameters and Immuno-histochemistry.
* To assess the multivariate prognostic value of standard parameters, PET-TDM FDG imaging parameters and Immuno-histochemistry defined as relevant to 2-year event-free survival .
* Construction of an optimal prognostic nomogram combining independent parameters to isolate different prognostic subgroups.

Eligibility Criteria:
Inclusion Criteria:

* Patient with biopsy-proven triple-negative breast cancer, newly diagnosed, naïve from any treatment.
* Age - 18.
* Performance Status (PS) : 0 or 1.
* No metastasis on the extension balance.
* Treatment provided immediately by lumpectomy or mastectomy, and accepted by the patient.

Exclusion Criteria:

* Severe illness or comorbidity at risk.
* A history of cancer within 5 years, with the exception of skin carcinomas (other than melanoma) or in-situ cervical carcinomas.
* Patient candidate for neo-adjuvant therapy.
A Study of FCX-007 for Recessive Dystrophic Epidermolysis Bullosa

The purpose of this study is to determine whether administration of FCX-007 in addition to standard of care improves wound healing as compared to standard of care alone (control) in children, adolescents, and adults with Recessive Dystrophic Epidermolysis Bullosa.

Funding Source - FDA OOPD

DEFI-RDEB is a multi-center, intra-patient randomized, controlled, open-label, Phase 3 study of FCX-007 for the treatment of persistent non-healing and recurrent RDEB wounds in approximately 24 subjects. Each subject will serve as his/her own control. Each subject's target wounds will be paired then randomized to receive FCX-007 (treatment wound) or remain untreated (control wound). Up to three target wound pairs will be identified for each subject.

Subjects will receive intradermal injections of FCX-007 in each specified treatment wound in two or more treatment sessions. The first treatment session occurs at Day 1 and the second at Week 12/Month 3. Additional treatment sessions may occur at Week 24/Month 6 and Week 36/Month 9 when unclosed treatment wounds may be re-treated, and unclosed control wounds may be treated. Safety and efficacy assessments will occur at scheduled intervals through Week 48/Month 12, when the treatment period is completed, and a long-term safety follow-up period (through 15 years) commences for subjects who have received one or more FCX-007 injections.

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female ≥2 years of age at the Screening visit.
* Clinical diagnosis of RDEB with confirmation of COL7A1 genetic mutation.

Key Exclusion Criteria:

* Medical instability limiting ability to travel to the investigative site.
* Active infection with human immunodeficiency virus, hepatitis B or hepatitis C.
* The presence of COL7 antibodies.
* Evidence of systemic infection.
* Evidence or history of squamous cell carcinoma at the site to be injected.
* Evidence of or history of metastatic squamous cell carcinoma.
* Known allergy to any of the constituents of the product.
* Female who is pregnant or breastfeeding.
* Receipt of a chemical or biological intervention for the specific treatment of RDEB in the past three (3) months prior to screening or anticipated/planned during the screening and treatment period for this study.
Efficacy of Pain Neurophysiology Education in Combination With Motor Control Training for Unspecific Low Back Pain

The purpose of the present study is to evaluate whether the addition of two pain neurophysiology education sessions to motor control training may result in an improvement of the outcome measures of pain and disability, compared to motor control training alone.

Sixty-two subjects with unspecific low-back pain were randomly recruited for the present study. The subjects were randomly allocated to a control group (which received only motor control training) and an intervention group (which underwent two pain neurophysiology education sessions prior to motor control training). Primary outcome measures were pain (measured with the Visual Analogical Scale) and disability (measured with the Oswestry Disability Index). Secondary outcome measures are kinesiophobia (Tampa Scale for Kinesiophobia), the global perceived effect (Global Perceived Effect Scale) and quality of life (SF-12). These will be measured before the intervention, at the end of the intervention, and 3 and 6 months after ending the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Unspecific low back pain for at least 3 months
* Patients must be knowledgeable in the language in which the educational sessions will be provided (Spanish)

Exclusion Criteria:

* Specific low back pain (e.g. infection, tumor, fracture, radiculopathy).
* Signs and symptoms of neuropathic pain or generalized chronic pain.
* History of lumbar or cervical spine surgery.
* Pregnancy.
* Concomitant pathologies that impede the performance of exercises.
* Psychiatric treatment.
A Study of MK-0822 in Postmenopausal Women With Osteoporosis to Assess Fracture Risk (MK-0822-018)

The purpose of the event-driven base study is to determine the safety and efficacy, especially fracture risk reduction, of odanacatib in postmenopausal women diagnosed with osteoporosis. In a placebo-controlled extension of the base study, participants continued to receive the same blinded study medication for a total of up to 5 years of blinded study medication combined between the base study and the extension. After participants received 5 years of blinded study medication, they received open-label odanacatib through the end of the first extension. Participants were then invited to enroll in a second extension study in which they received open-label odanacatib for an additional 5 years. Two imaging substudies (PN032-Base/Extension and PN035) were conducted for participants in the MK-0822-018 Study. Additional safety information was collected for participants who discontinued from the base study or the blinded first extension in an observational follow-up study, MK-0822-083 (EudraCT number: 2007-002693-66) .


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women (for at least 5 years) who are ≥65 years of age and have low bone mineral density
* Ambulatory (able to walk)

Exclusion Criteria:

* Must not be taking osteoporosis therapy or have a metabolic bone disorder other than osteoporosis
* Has or has had a hip fracture
* Currently participating in another drug study
Observational Study to Assess Optimal ECPR Settings After Resuscitation

Rationale: Veno-arterial extracorporeal membrane oxygenation (vaECMO) during cardiopulmonary resuscitation (ECPR) might improve outcome after cardiac arrest. However, it is well established that reperfusion injury of the brain can cause microvascular and endothelial dysfunction, leading to cellular necrosis and apoptosis. While performing ECPR, following the European resuscitation guidelines, it is yet unknown how to set the ECMO settings in order to minimize ischemia-reperfusion injury of the brain.

Objective: In this study, we want to elaborate on the optimal ECMO settings in the first three hours after initiation of ECPR.

Study design: Prospective, multi-centre, observational study Study population: All patients receiving ECPR in the age between 18 and 70 years, with low flow duration\<60min and receiving cerebral oximetry monitoring Intervention: application of an adhesive regional oximetry sensor on the patient's forehead and withdrawal of 12 ml extra blood in all patients.

Main study parameters/endpoints: Cerebral Performance Category at 6 months. Neuron-specific enolase (NSE) will be determined from routine blood drawings.


Eligibility Criteria:
Inclusion Criteria:

* Witnessed cardiac arrest or signs of life during CPR (such as gasping or movement)
* Age\>18 and \< 70 years
* Duration of low-flow \< 60 min before decision to proceed with ECPR
* High quality CPR (defined as end-tidal carbon dioxide (CO2et) \>10 mmHg) provided for a minimum of 15 minutes without return of spontaneous circulation (ROSC)
* Presumed cardiac cause of cardiac arrest (such as Chest pain before collapse, ventricular tachycardia/ventricular fibrillation (VT/VF) as initial rhythm or ST-elevation on ECG)
* Cerebral oxymetry monitoring initiated during CPR preceding ECPR

Exclusion Criteria:

* Patients with a GCS\<15 before CPR.
* Known pre-arrest cerebral performance category CPC ≥ 3
* Presumed noncardiac cause
* Unwitnessed collapse
* Suspected or confirmed pregnancy
* ROSC within 5 minutes of Advanced cardiopulmonary life support (ACLS) performed by emergency medical service (EMS) team
* Conscious patient
* Known bleeding diathesis or suspected or confirmed acute or recent intracranial bleeding
* Suspected or confirmed acute stroke
* Known severe chronic organ dysfunction or other limitations to therapy
* "Do not resuscitate" order or other circumstances that make 180 day survival unlikely
An Observational Study on Renal Function in Kidney Transplant Participants on Immunosuppressive Therapy Containing Mycophenolate Mofetil

This observational study will evaluate renal function in participants who underwent renal allograft transplantation and are started on combined immunosuppressive treatment containing mycophenolate mofetil (CellCept). Eligible participants will be followed for 12 months following transplantation.

The participant sampling method used in the Orange study was consecutive sampling, a non-probability sampling method where each participant meeting the study's inclusion and exclusion criteria is selected and enrolled in the study until the pre-set sample size is achieved.

Thus, in the Orange study de novo kidney transplanted participants, who were on mycophenolate mofetil immunosuppressive combination therapy in routine clinical practice, were selected in a consecutive manner (a non-probability sampling method) if they met the inclusion/exclusion criteria until 128 participants were recruited to the study.

Eligibility Criteria:
Inclusion Criteria:

* Participants who underwent renal allograft transplantation and are started on combined immunosuppressive treatment containing mycophenolate mofetil in accordance with the indication provided by the SmPC of mycophenolate mofetil
* Date of study enrollment is the date of kidney transplantation

Exclusion Criteria:

* Contraindication included in the SmPC for capecitabine (Xeloda) prevailed, like: Hypersensitivity to active ingredient or any of the excipients of the product; Pregnancy and lactation