cyrilzakka/clinical-trials huggingface dataset:
Impact of Physical Activity and Diet on Symptom Experience in People Living With HIV

We will conduct a four-year, observational study of 850 participants to measure physical activity and diet, once a year for three years. All participants will also complete the standard Centers for AIDS Research (CFAR) Network of Integrated Clinical Systems (CNICS) patient-reported outcomes (PRO) and clinical assessment procedures. An enhanced PRO assessment (consisting measures of physical activity, diet intake and anthropomorphic factors) will be included after the routine patient clinic visit at four CNICS sites: Case Western Reserve University, University of Alabama at Birmingham, University of Washington, and Fenway Health.

PROSPER-HIV is a four-year, prospective, observational study of 850 CNICS participants who will complete an enhanced patient-reported outcome (PRO) assessment to measure physical activity and diet intake, once a year for three years. All participants will also complete the standard CNICS PRO and clinical assessment procedures. We propose to integrate the following measures, physical activity (triaxial accelerometery), dietary intake (24-hour diet recalls), and anthropomorphic factors (waist-hip-ratio), into an enhanced annual assessment of patient reported outcomes at four CNICS sites: Case Western Reserve University, University of Alabama at Birmingham, University of Washington, and Fenway Health. Our four primary objectives are to:

1. Identify and characterize longitudinal, objectively measured, physical activity and dietary patterns among PLHIV
2. Examine the relationship between objectively-measured physical activity and self-reported physical activity on the Lipid Research Clinics Physical Activity Questionnaire.
3. Determine which aspects of physical activity patterns and diet quality are associated with decreased symptom burden and intensity in PLHIV, and if this relationship is moderated by age and sex.
4. Explore the potential mediating effect of anthropomorphic and physical fitness variables on the relationships between physical activity, dietary patterns, and symptom burden and intensity in PLHIV.

We hypothesize that people living with HIV who 1) have more intense, frequent and longer physical activity bouts will have age- and sex-dependent reduced symptom burden; 2) eat better quality diets (e.g., more fiber and protein, fewer carbohydrates) will have reduced symptom burden and intensity and that this relationship will also vary by age and sex.

Eligibility Criteria:
Inclusion Criteria:

1. Be an active CNICS participant
2. aged ≥18 years
3. prescribed HIV antiretroviral therapy, and
4. have an undetectable HIV viral load: defined as the most recent HIV viral load \<200 copies/mL, checked within the past year.

Exclusion Criteria:

1) Did not complete the HIV Symptom Index in the PRO assessment (2) No reliable access to a telephone or internet-enable telephone services needed to complete the 24-diet recalls (3) Was pregnant, breast-feeding, or planning a pregnancy at the time of PRO assessment (4) Planning to move out of the area in the next 36 months, or (5) Non-English speaking.
Evaluation of the Efficacy of the BrainPort Vision Pro on the Performance of Daily Activities in the Profoundly Blind French Population

The purpose of the study is to evaluate the effectiveness and safety of the BrainPort® Vision Pro, an electronic oral assistive device, in the performance of daily tasks by French persons who have residual vision limited to light perception or less in both eyes.


Eligibility Criteria:
Inclusion Criteria:

1. 8 years of age or older
2. Diagnosis of profound blindness with residual vision limited to a perception of light or lower in both eyes.
3. Minimum post 12 months diagnosis of blindness
4. Previously completed conventional rehabilitation such as orientation and mobility training with a cane or guide dog.
5. Ability to be read and to understand the documentation and procedures of the study.
6. Ability to provide feedback on the use of the BrainPort Vision Pro device.
7. Ability to use basic computer and/or other technologies.
8. Willing and able to answer all questionnaires, carry out telephone follow-ups, undergo device training and carry out all study procedures, after having passed the orientation phase with the device.
9. Participant or his legal representative willing and able to sign informed consent.

Exclusion Criteria:

1. Ongoing oral disorders determined on the basis of the participant's medical history and/or by an examination of the oral cavity by a dental specialist.
2. History of tongue damage resulting in sensitivity problems or impaired language.
3. Visible open sores, herpes, abrasions, blisters or rashes on the tongue or numbness of the tongue.
4. Piercings on the tongue.
5. Planned or recent oral surgery (in the last 3 months) and/or dental care (excluding oral check-ups or routine scaling).
6. Known neuropathy of the language or sensory system.
7. History of seizures or epilepsy.
8. Pregnant woman, willing to be pregnant or lactating. Women of childbearing age should consent to the use of appropriate contraception to avoid pregnancy during the study period.
9. Implanted medical devices (e.g., pacemaker, deep brain stimulation device, cochlear implant).
10. Any hearing impairment that prevents you from hearing the device's announcements.
11. Cognitive impairment detected on the basis of medical history and/or during a cognitive impairment telephone interview.
12. Expected or ongoing participation in another clinical trial or any research that may interfere with this study.
13. Known allergy to nickel, gold or a stainless-steel component.
14. Any health condition that may interfere with the study's evaluations.
15. A person unable to assemble the device and/or interpret the device's signals or who refuses to continue to participate in the study after passing the initial training phase with the device.
16. Person deemed unfit to participate in the study by the lead investigator for any other previously cited reason.
17. Adults who do not have the ability to provide valid informed consent (under legal protection)
Emtricitabine for Naive Chinese Pregnant Chronic Hepatitis B Patients

This study evaluates generic emtricitabine(FTC) efficacy and safety in Chinese naive pregnant chronic hepatitis B patients. Single group patients were enrolled to receive emtricitabine till 48 weeks after delivery.

Single group patients were enrolled to receive emtricitabine till 48 weeks after delivery, which include HBeAg positive and negative patients.

Eligibility Criteria:
Inclusion Criteria:

* HBsAg positive for more than 6 months
* HBeAg positive patients: HBV DNA ≥ 5log10 copies/ml
* HBeAg postive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4
* HBeAg negative patients: HBV DNA ≥ 4log10 copies/ml
* HBeAg postive patients: ALT≥2×ULN;or liver biopsy G≥2;or liver biopsy S ≥2;or liver biopsy Knodell HAI ≥ 4
* Nucleoside/nucleotide naive patients
* Diagnosed as ≥ 12 weeks pregnancy

Exclusion Criteria:

* Diagnosed HCC with AFP and ultrasound, CT or MRI
* Creatine \>130μmol/L or Ccr \< 70mL/min
* Hemoglobin \<100g/L
* Coinfected with HAV,HEV,HCV,HDV or HIV
* ANA \> 1:100
* Uncontrolled cardiovascluar diseases, kidney diseases,lung diseases, neurological diseases, digestive diseases,metabolic disorders, immune-compromised diseases or cancer
* Drug abuse or alcohal addiction
* Previous history of taking agents of lamivudine, adefovir, tenofovir entecavir or telbivudine
* Long-term use of immunosuppressor or immunomodulator 6 months before enrollment to this trial
* Underwent liver transplantation or liver transplantation in schedule
* Allergic to nucleoside or nucleotide analogues
* Family history of genetic defects disease
* Abnormal results in fatal defects screening
* HBsAg positive sperm provider pregnancy
Open Label Extension Study of Epratuzumab in Japanese Systemic Lupus Erythematosus (SLE) Subjects

The study is an open-labeled extension study to continue to assess the safety and tolerability of Epratuzumab in moderate to severe SLE subjects who have previously participated in SL0026 \[NCT01449071\] phase I/II trial.


Eligibility Criteria:
Inclusion Criteria:

* Subject has completed the double-blind study SL0026 \[NCT01449071\] or terminated prematurely at Week 8 or later in SL0026 \[NCT01449071\] due to lack of efficacy
* Women of childbearing potential must agree to use an acceptable method of birth control/Written Informed Consent

Exclusion Criteria:

* Subjects with active, severe SLE disease activity which involves the renal system and active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring British Isles Lupus Assessment Group Index (BILAG) level A
* Subjects with concurrent relevant medical conditions like defined chronic infections or high risk of new significant infections
* Substance abuse or dependence
* Significant hematologic abnormalities
* History of malignant cancer
* Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion
TIPS for Variceal Rebleeding in Cirrhotic Patients With Occlusive Portal Vein Thrombosis and CTPV

To date, there is no treatment strategies for these patients according to American Association of the Study of Liver Disease (AASLD) practice guidelines and Baveno V consensus. Thus, we aim to compare the safety and efficacy of TIPS and conservative treatment (non-selective beta blockers, endoscopic therapy and/or anticoagulation) in patients with PVT and CPTV.

The incidence of portal vein thrombosis (PVT) is about 16% in cirrhotic patients. Chronic PVT often cause two main undesirable consequences: symptomatic portal hypertension (such as variceal bleeding or ascites) and cavernous transformation of portal vein (CPTV). The former could lead to death and the latter increases the difficulty of the transjugular intrahepatic portosystemic shunt (TIPS) treatment, which is considered as a main effective treatment for symptomatic portal hypertension. Some patients with CPTV and variceal bleeding only have to receive conservative treatment (non-selective beta blockers, endoscopic therapy and/or anticoagulation). With advances in technology, modified TIPS procedure could significantly improve the operation success rate of patients with CPTV. To date, the difference in safety and efficacy between TIPS and conservative treatment (non-selective beta blockers, endoscopic therapy and/or anticoagulation) in patients with PVT and CPTV is still unclear.

Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosis with portal vein thrombosis and cavernous transformation of portal vein and portal hypertension by contrast enhanced CT or MRI.
* History of variceal bleeding.
* Liver cirrhosis.
* Neutrophilous counts≥ 1.5×109/L, Platelet counts ≥ 50 × 109/L, Hemoglobin≥ 85g/L.
* Albumin ≥2.8 g/dL, total bilirubin \<51.3 umol/L; alanine aminotransferase (ALT) and aspartate transaminase（AST）\<5 times of upper limit.
* PT(Prothrombin time)-INR(international normalized ratio) \< 1.7.

Exclusion Criteria:

* Thrombosis involve superior mesenteric vein, splenic vein, or the whole portal vein system. Not suitable for TIPS (judged by principal investigator).
* Company with malignant tumors in liver or other organs.
* Patients with known severe dysfunction of heart, lung, brain or kidney.
* Active bleeding.
* Not eligible for anticoagulation therapy,non-selective beta blockers or endoscopic therapy.
* Uncontrolled infection.
* Pregnancy and breastfeeding.
* HIV infection.
TearLab Refractive Surgery Dry Eye Study

The primary objective of this study is to determine how pre \& post-operative tear osmolarity levels relate to rates of dry eye symptoms related to refractive surgery and if differences exist in patients who are pre-treated with ocular lubricants vs. those treated only post-operatively.

Dry eye disease is a common and major source of disability, whether occurring as a primary disorder or as a component of other diseases and its onset may be triggered or modified by exposure to systemic drugs, contact lens wear, ocular surgery and adverse environmental and work conditions. The development of a reliable, highly sensitive and specific test for the clinical diagnosis of dry eye is a major unmet clinical need, particularly to differentiate it from common conditions such as ocular allergy which exhibit similar presenting symptoms. Tear hyper-osmolarity is central to the dry eye disease process and the measurement of tear osmolarity could serve not only as a highly accurate diagnostic test but also as a measure of disease severity and a means to monitor treatment efficacy.

Recently, there have been reports in the literature regarding dry eye disease; both early and chronic following refractive surgery, with many cases potentially being previously inadvertently undiagnosed dry eye disease.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, twenty-one years of age or older.
* Confirmed diagnosis of refractive error receiving LASIK surgery.
* Patient motivation and willingness to cooperate with the investigator and ability to return for all visits during the study.

Exclusion Criteria:

* Compromised cognitive ability that may be expected to interfere with study compliance.
* Clinically significant eyelid deformity or eyelid movement disorder that is caused by conditions such as notch deformity, incomplete lid closure, entropion, ectropion, hordeola or chalazia.
* Previous ocular disease leaving sequelae or requiring current topical eye therapy other than for DED, including, but not limited to: active corneal or conjunctival infection of the eye and ocular surface scarring.
* Active ocular allergy
* Patients requiring punctual occlusion prior to surgery
* Patients requiring cyclosporine ophthalmic emulsion prior to surgery
* Standard exclusion criteria for refractive surgery used by each surgeon.
* Known hypersensitivity to any of the agents used in testing
* Ophthalmologic drop use within 2 hours of any visit
A Study of Safety and Effectiveness of Bendamustine Hydrochloride in Adult Filipino Patients With Chronic Lymphocytic Leukemia

The purpose of this study is to assess safety and effectiveness of extended bendamustine in the treatment of chronic lymphocytic leukemia (CLL).

This is a Phase IV, open label (all people know the identity of the intervention), multi-center, observational (a scientific study to make a clear and easy understanding of the cause and effect relationship) study of bendamustine. The study duration is of 24 Weeks to coincide with the 4 weeks-6 cycles bendamustine treatment. The study will run for three years, and will enroll 10 percent of patient who would use this product, as a requirement of the Philippine Food and Drug Administration (FDA). Approximately fifty patients will be enrolled in this study. Safety evaluations including adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination will be monitored throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* Adult Filipino patients with chronic lymphocytic leukemia
* Patients who are cytologically-diagnosed with chronic lymphocytic leukaemia (symptomatic Binet stage B or C) and for whom fludarabine combination chemotherapy is not appropriate
* World health organization performance Status of 0, 1, or 2
* Need-to-treat criteria in B-cell chronic lymphocytic leukemia

Exclusion Criteria:

* Had received previous treatment with other cytotoxic drugs
* Had a history of a second malignancy (except cured basal cell carcinoma or cured cervical cancer)
* Concomitant illnesses such as overt heart failure, cardiomyopathy, myocardial infarction within the last 6 months, severe uncontrolled diabetes mellitus, severe uncontrolled hypertension, active infection that required systemic antibiotic treatment in an investigational drug study within 30 days prior to selection
* Patients with severe renal and hepatic impairment
* Patients with severe bone marrow suppression and severe blood count alterations
* Pregnant women and lactating mothers
Validation of Chinese Version Appropriate Use Criteria for Coronary Revascularization

Coronary revascularization (CR) is increasing rapidly in China and varies significantly in proportion ( PCI:CABG=15:1). Few studies assess the appropriateness of CR in China. Recently, National Center for Cardiovascular Disease organized experts to release Chinese version appropriate use criteria(C-AUC) for coronary revascularization by RAND method aimed at regulating indications of CR. The criteria is considered to contribute to clinical practices, quality assessment and health insurance policy, however, the validation of C-AUC is unknown.

Thus the investigators study aims at assessing the validation of Chinese AUC by multi-center prospective registry. The investigators will recruit 4000 patients undergoing elective coronary angiography with positive outcome consecutively and collect baseline information. Sequently, one-year follow up will be done to collect the prognose, including death, rehospitalization, medicine, medical compliance and life quality etc. One hand, the investigators will compare the outcomes between different therapies in the same indications according to C-AUC to evaluate the validation of C-AUC. On the other hand, the investigators will evaluate the rationality of CAD therapy in Beijing by C-AUC.


Eligibility Criteria:
Inclusion Criteria:

* Undergo elective coronary angiography in department of cardiology in period of study
* Written informed consent

Exclusion Criteria:

* Age ≤18 years of age
* Illiteracy, vision/audition disorder, cognitive disorder etc
Neuropsychological Impairment and Quality of Life in Neurofibromatosis Type 1

The main objective of the study is to investigate the determinants of the quality of life in children and adults with Neurofibromatosis type 1 (NF1) and more particularly the specific impact of neuropsychological deficits. In fact, cognitive impairment is currently considered as one of the most pervasive features of this genetic disorder but its relationship with the worsening of quality of life found in this population has not been directly investigated to date.

Secondary objectives of this study are (i) to compare neuropsychological and quality of life measures between patients and healthy controls matched by age, gender and education level, (ii) to contrast neuropsychological deficits incidence between patients and controls, and (iii) to differentiate NF1 children's self versus hetero-assessment of quality of life.

The main hypothesis of this study is that the neuropsychological impairment classically identified in this clinical population will be associated to the quality of life's worsening both in children and adults.

The study cohort will consist of 150 patients with NF1 (100 adults and 50 children) recruited from the Neurofibromatosis Clinic at the University Hospital in Nantes and Créteil (France). A sample of 150 healthy controls (100 adults and 50 children) will also be recruited from sport and leisure clubs to serve as a normally developing control group.

The protocol assessment includes a standard and thorough neuropsychological examination specific to children and adults, to investigate the different aspects of cognitive domains: language, visuoperceptive and visuomotor abilities, memory, attention, executive function and intelligence skills. Quality of life is measured by a questionnaire specifically adapted to children and adults.

Other factors linked to the NF1 disease (familial or sporadic form, severity and visibility) and to demographic characteristics (sex, age, education level) will be taken into account to study their respective impact on quality of life, as compared with neuropsychological measures.

Eligibility Criteria:
Inclusion Criteria for Patients :

* NF1 diagnosis following National Institutes of Health criteria (1988)
* Age: 8-12 years for children, 18-59 years for adults
* Signed informed written consent (parent and patient for children, patient for adults)
* French speaking
* Resident in France

Inclusion Criteria for Healthy controls:

* Absence of NF1 diagnosis, learning disabilities, intellectual precocity
* Age: 8-12 years for children, 18-59 years for adults
* Signed informed written consent (parent and healthy control for children, healthy control for adults)
* French speaking
* Resident in France

Exclusion Criteria:

* Uncorrectable hearing of visual impairment
* History of psychiatric illness
* Neuropsychological investigation in the last 6 months
* Insufficient language usage
* Any other known history of central nervous system pathology or neuropathological complications of NF1
Periprosthetic Fracture Following Tibial Echinococcosis

Cystic Echinococcus in the bone is rare, comprising 0.5% to 2.5% of all human hydatidosis Association of Hydatid disease to pathologic fractures involving knee prosthesis have not yet been described A combined surgical and medical approach is of paramount importance to avoid recurrence Resulting osseus defects is challenging and require specific prosthesis when treating this entity.

Hydatid disease in humans caused by the parasitic tapeworm Echinococcus granulosus has an osseous involvement of about 0.5% to 2.5% of all cases in humans. The location of hydatid cysts in the tibia is seldom described in the medical literature, and its diagnosis and treatment is challenging.

This paper presents a patient, with a long term, well tolerated, bilateral total knee arthroplasty (TKA), treated at our clinic, with a recent history of pain and oedema in her left upper leg. After achieving a, radiologically and histopathologically, well documented, diagnosis of Echinococcosis lesion in her left proximal tibia, a surgical intervention was planed, a wide resection of the cyst performed, and a specific anti-helmintic therapy was instituted. Four years later the patient returns to the investigators observation complaining of pain and unable to bear weight on her left knee, from which a pathologic fracture, adjacent to the tibial component was diagnosed.

After surgical debridement of the newly advanced hydatid cyst growth, the TKA was revised, and due to the tibial component failure and the femoral implant loosening, a semi-constrained total knee revision arthroplasty was executed. Functional outcome was excellent.

Although challenges in treatment of musculoskeletal hydatid cysts (HC) lesions have been documented, data regarding the musculoskeletal HC lesions resembling tumor is scarce, and those resulting in a prosthetic failure haven't been published. The authors intend to add data concerning the therapeutic approach to this entity.

Eligibility Criteria:
Inclusion criteria

* Patients with echinococcus infection
* Patients which this infection compromises knee stability.

Exclusion criteria

* bacterial infection
* immunocompromised patients