cyrilzakka/clinical-trials huggingface dataset:
Duration of Dual Antiretroviral Therapy in Virologically Suppressed People Living With HIV and Factors Associated With Switching to Tritherapy : a Real-life Cohort

HIV infection requires lifelong continuous antiretroviral (ARV) treatment. The efficacy of current ARV treatments makes it possible to propose strategies for reducing the cumulative exposure to ARVs, side effects and costs. And so improve the quality of life of people living with HIV (PLHIV). However, in the real world, less regular adherence to treatment, more heavily pre-treated patients and resistance to treatment make these dual therapies prescribed beyond the strict framework of clinical trials. This can lead to undesirable side effects. From the perspective of personalized medicine, it seems to be important to determine which patients are receiving dual ARV therapy, and which patients remain on it for a long time. Identifying prognostic factors would enable us to adapt therapeutic management.


Eligibility Criteria:
Inclusion Criteria:

* hiv patient
* viral load \< 50copies/ml
* patient treated with dual therapy
* patients with hospital follow-up between 2011 and 2023

Exclusion Criteria:

* adults under legal protection
* underage
Transplantation of HUC-MSCs With Injectable Collagen Scaffold for POF

Cellular therapies are rapidly progressing fields and have shown immense promise in the treatment of damaged ovarian function. The purpose of this study is to determine safety and efficacy of intra-ovarian injection of allogeneic HUC-MSCs with injectable collagen scaffold in women with Premature Ovarian Failure (POF) and to study the preliminary efficacy of HUC-MSCs with injectable collagen scaffold injection on ovarian function improvement.

The purpose of this study was to explore the therapeutic potency of the HUC-MSCs with injectable collagen scaffold transvaginal injection for POF women. The serum of each patient was kept and sent for laboratory test before the surgery. HUC-MSCs were isolated and cultured in vitro and the biomarkers of HUC-MSCs were detected using Flow cytometry detection. The HUC-MSCs with injectable collagen scaffold were then injected directly into bilateral ovaries. The outcomes of patients were examined after the injection. The patients are monitored for signs of follicle growth and growing follicles are stimulated with exogenous hormones, followed by oocyte retrieval and In Vitro Fertilization (IVF).

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with Premature Ovarian Failure.
2. Patients show no response to drug treatment
3. Women between 20 and 39 years.
4. Willing to sign the Informed Consent Form.

Exclusion Criteria:

1. Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome).
2. Congenital ovarian malformation.
3. Severe endometriosis.
4. Thyroid dysfunction.
5. Contraindications for pregnancy.
6. Contraindications for hormone replacement therapy.
7. Prior personal history of ovarian cancer or after radiotherapy.
8. Unwilling to comply with follow-up schedule or want to take other treatment during the follow-up period.
A Group Therapy Based on the Bio-psycho-social Treatment Approach for Women With Chronic Pelvic and Chronic Belly Pain

The project investigates the situation of patients with chronic pelvic and chronic belly pain before and after our group therapy.

To treat patients with chronic pelvic and belly pain in an interdisciplinary way, we developped a group therapy consisting of twelve sessions and a booster session. The therapy is based on the bio-psycho-social model of pain and includes group sessions of psychotherapy as well as physiotherapy.

All patients fill in questionnaires (concerning pain impact, pain chronicity, depression, anxiety, stress, well-being and sexuality) before and after the therapy as well as three and twelve months after.

Eligibility Criteria:
Inclusion Criteria:

Women with chronic pelvic pain or belly pain participating in our group therapy who give their consent to the analysis of their data for the study

Exclusion Criteria:

* No participation in the group therapy
* Finishing the group therapy prematurely (\>3 missed sessions)
Menier's Disease - Bone Density Study

Meniere's disease is a progressive and debilitating inner ear disease characterised by vertigo and hearing loss. Several studies have linked Menierws disease with lower bone density and lower vitamin D levels. In the current prospective study definite Meniere's patients will be followed over a period of 2 year, during which repetitive measurements of bone density, vitamin D plasma levels, blood pressure as well as hearing and vestibular tests will be made. Results will be compared to healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* Definite Meniere's disease

Exclusion Criteria:

* hyperthyroidism
* hyperparathyroidism
* acromegaly
* hypogonadism
* diabetes melitus
* chronic renal failure
* alcoholism
* cushing syndrome
* rheumatoid arthritis
* systemic lupus erythematosus
* ankylosing spondylitis
* inflammatory bowel disease
* obstructive lung disease
* sarcoidosis
* amyloidosis
* celiac disease.
* chronic treatment with bisphosphonates
* chronic treatment with glucocorticoids
* chronic treatment with androgen deprivation therapy
* chronic treatment with gonadotropin releasing hormone agonist chronic treatment with aromatase inhibitor chronic treatment with loop diuretics chronic treatment with proton pump inhibitors chronic treatment with anti-seizure drugs chronic treatment with warfarin chronic treatment with SSRI chronic treatment with alpha or beta-blockers
Prospective Randomized Study Comparing Laparoscopic Versus Open Partial Nephrectomy

Partial nephrectomy is considered the standard treatment for renal tumors smaller than 7 cm. With the evolution of image diagnostic tools and dissemination of its use, smaller tumors are being commonly diagnosed and treated. The partial open nephrectomy is still considered the gold standard technique for nephron sparing surgery, especially when the surgeon is not experienced with the minimally invasive surgery. In the last 15 years, uncountable minimally invasive techniques were developed, including the laparoscopic partial nephrectomy. The objective of this study is compare the partial laparoscopic nephrectomy to open partial nephrectomy in terms of perioperative, oncologic and functional outcomes. A balanced randomized prospective trial will be conducted. One group of patients will be submitted to to open partial nephrectomy while the other group of patients will be submitted to laparoscopic partial nephrectomy. A randomized prospective trial comparing the two techniques is necessary to determine the differences in outcomes between them and if the laparoscopic partial nephrectomy can be performed without harms to the patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with renal tumor cT1N0M0; (\<7 cm)
* Normal renal function (serum creatinine \<1.2 and glomerular filtration rate\> 60mL/min/1.73m2)
* Tumor only

Exclusion Criteria:

* Functional or anatomical solitary kidney
* Horseshoe kidney, ectopic or malformed
* Clinical contraindication to surgery
* Contraindication to laparoscopic surgery
* Association with other renal pathologies
* Evidence of lymph node or systemic disease in preoperative staging
Collaborative Lifestyle Intervention Program in Knee Osteoarthritis Patients

The Collaborative Lifestyle Intervention Program in Knee OsteoArthritis Patients (CLIP-OA) compares a novel community-based exercise and dietary weight loss program to the Arthritis Foundation's Walk with Ease intervention on improved mobility in knee osteoarthritis (OA) patients.

Knee OA is a chronic, progressive, degenerative disease that affects over 20 million Americans, and is cited as the primary cause for activity restriction and physical disability in older adults. The joint damage and symptoms (i.e., pain, stiffness, and fatigue) accompanying symptomatic knee OA result in activity restriction, muscle atrophy, reduced quality of life and difficulty in performance of functional tasks.

Despite the well-established benefits of the Arthritis Foundation's (AF) exercise programs, recent evidence suggests that lifestyle interventions combining Exercise and Dietary Weight Loss (EX+DWL) results in superior improvements in key clinical outcomes in older, overweight or obese knee OA patients.

Primary Aim: To compare the effects of a novel community-based EX+DWL program to AF's Walk with Ease (WWE) EX intervention on improved mobility in knee osteoarthritis (OA) patients.

Secondary Aim: To compare the cost effectiveness and effects of the EX+DWL and WWE interventions on weight loss, pain, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with knee OA: physician documented radiographic tibiofemoral OA of one or both knees
* Overweight or Obese: BMI \>25 and \<40
* Knee Pain and Risk for Mobility Disability: self-reported difficulty walking ¼ mile, climbing stairs, lifting or carrying groceries, or performing other household activities due to knee pain
* Sedentary: sedentary lifestyle defined as currently participating \< 20 minutes of weekly structured moderate intensity exercise occurring in bouts \>10 min
* Health Status: all participants must be free of severe heart or systemic disease that would make moderate intensity exercise participation unsafe
* Age: \> 50 years of age
* Stability of Residence: does not plan to move out of the Columbus metropolitan area for the duration of the study
* Consents: willing to give an informed consent and sign a HIPPA authorization form; (9) Physician Consent: treating rheumatologist and primary care physician provide medical consent for participation
* Agreeableness: willing to accept randomization and complete all assessment and intervention procedures

Exclusion Criteria:

* Health Status: any serious medical condition that precludes safe participation in an exercise program
* Study Staff Judgment: Inability to complete the study protocol, in the opinion of the study staff, due to frailty, illness, or other reasons
Extension Study With Tosedostat in Relapsed/Refractory Acute Myeloid Leukemia

The purpose of this study is to evaluate the long-term efficacy and safety profile of tosedostat in elderly patients suffering from refractory or relapsed Acute Myeloid Leukemia.

Extension protocol to the OPAL Study (CHR-2797-038).

Study mimics normal clinical practice; few procedures and visits are therefore mandated by the protocol. Timing of bone marrow assessment is also left at the investigator's discretion.

Eligibility Criteria:
Inclusion Criteria:

* Signed, informed consent
* Completion of Visit 11 in the OPAL Study (Month 6 Visit)
* Investigator's opinion that the subject would benefit from continued therapy with tosedostat.

Exclusion Criteria:

* Any co-existing medical condition that in the Investigator's opinion will substantially increase the risk associated with the subject's participation in the study
* Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of the necessary studies
* Administration of any (other) investigational agent within 14 days of entry into TOPAZ.
A Study to Determine the Prevalence of Inflammatory Dry Eye Disease in Patients Prior to Cataract Removal

This study will evaluate the prevalence of inflammatory dry eye disease in patients prior to cataract surgery. No treatment is administered in this study.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo cataract removal surgery

Exclusion Criteria:

* Current use of eye drops or oral medications for allergic conjunctivitis
* Serious ocular injury, intraocular surgery, or refractive surgery within 6 months in the study eye
* Use of a contact lens within 4 weeks
Snodgrass Versus Grafted Snodgrass Repair in Narrow Urethral Plate in Distal Penile Hypospadias

We aime to compare between Snodgrass and grafted Snodgrass repair in the outcome in distal penile hypospadias with urethral plate less than 8mm

The main goal for hypospadias repair is to achieve both cosmetic and functional normality.

Several surgical techniques for hypospadias repair have been developed that depend on the site of the urethral meatus in children The effect of the urethral plate characteristics on the surgical outcome of Snodgrass repair has been studied in many series. Some documented that urethral plate width has a significant impact on the complication rates Holland and Smith reported a high complication rate in Snodgrass repair with a urethral plate width of less than 8 mm 7 The augmentation of the urethral plate either with inlay graft (DIGU, Snodgraft, or G-TIP), Onlay preputial flap, or other flaps carries a better outcome than the original TIP in many studies Others denied any effect of the narrow urethral plate on the success rate We aim in this study to determine which is better in narrow urethral plate in distal penile hypospadias, as regarding surgical and cosmetic outcomes; Snodgrass or combined inner preputial graft with Snodgrass

Eligibility Criteria:
Inclusion Criteria:

Children age: \> 6m up to 16y

* Distal penile hypospadias(distal shaft,coronal,subcoronal )
* mid penile hypospadias with mild chordae les 30 degree
* Urethral plate \<8 mm in maximum transverse diameter before the midline urethral plate incision .Primary non-circumcised cases of hypospadias

Exclusion Criteria:

* Proximal and mid penile hypospadias with marked chordae
* previous hypospadias repair
Long Term Maintenance of Drug Abstinence

The purpose of this study is to develop a model for long-term maintenance of behavior change by examining the effects of extending the duration of contingency management (CM) for drug abuse on long-term abstinence outcomes. The primary hypothesis is that the Extended (36 week) CM group will have better long-term outcomes as exhibited by greater rates of abstinence at each follow-up assessment as compared to the Standard (12 week) CM group.

This protocol examines the effects of extending the duration of contingency management (CM) for drug abuse and dependence on long-term abstinence outcomes. Following the tenets of basic behavioral research, we have outlined a model for long-term behavior maintenance that suggests that successful long-term behavior change does not focus on undoing old behaviors, but concentrates on developing new behaviors in a wide variety of new contexts, and provides enduring reinforcement for the new behaviors. The implication of this model is that in order to develop strategies for supporting long-term behavior change we need to determine the optimal duration of continuing treatment-arranged contingencies, better specify incompatible behaviors that emerge for patients who are successful in sustaining periods of continuous drug abstinence, and determine which incompatible behaviors are most likely to have naturally-occurring sustaining contingencies of reinforcement. This research will examine the model by randomly assigning cocaine-dependent or cocaine-abusing methadone maintenance patients to either a Standard (12 week) or Extended (36 week) period of contrived contingencies. We will be conducting a 2 year follow-up in order to investigate whether providing a longer duration of CM will result in a greater proportion of abstinent individuals during this time, how long the abstinence will last and to discover if longer durations of drug abstinence during the first year after treatment entry will predict better longer-term abstinence outcomes. We also compare outcomes on abstinence-related behaviors to see if provision of an extended voucher program leads to an increase in non-drug using natural reinforcers and activities. This study participates in the NIH-sponsored Health Maintenance Consortium designed to promote interchange of concepts, methods and measures related to the maintenance of long-term behavior change.

Eligibility Criteria:
Inclusion Criteria:

* Meet DSM-IV criteria for current cocaine dependence or abuse
* Be willing and able to give valid contact information
* Be receiving a stable dose of 40 milligrams or more of methadone

Exclusion Criteria:

* Are unable to give informed consent (fails simple open-ended consent quiz)
* Answer yes to the question "Are you in recovery from gambling? That is, have you stopped gambling because of previous problems with gambling?"
* Report that they have a romantic partner who is already participating in the study
Implementing IntelliCare in Collaborative Care: A Quality Improvement Evaluation

The overarching aim of the proposed project is to conduct a pragmatic, quality improvement evaluation of the IntelliCare Platform for improving processes of care in the Rush Collaborative Care program, and improving patient population depression outcomes, to determine the long-term utility of IntelliCare for Rush.

This study is a pragmatic, system-wide rollout quality improvement evaluation design displayed in Figure 1. The Rush IRB has waived consent for this quality improvement trial. Data from the EHR will be used beginning December 1, 2019. The first care manager (CM) will begin enrolling patients into IntelliCare in September, 2020. Additional CMs will begin using IntelliCare at approximately 3 month intervals. In September 2021, support for IntelliCare from the evaluation team will be withdrawn, to examine the sustainability of the IntelliCare Platform.

Patients Data from all patients, aged 18 or older, enrolled collaborative care from December 1, 2019 through August 31, 2022 will be used to evaluate the IntelliCare service. All CCT patients who are 18 or older, and have a smartphone will be offered enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in Rush Collaborative Care service
* Owns a personal smartphone

Exclusion Criteria:

* None
Lactobacillus Reuteri Feasibility Study on Probiotic Treatment and Perinatal Microbiome

Investigators want to investigate if the Lactobacillus Reuteri (probiotic bacteria) given to pregnant women can be found in different maternal compartments and in the first stool and oral swab collected immediately after birth of a newborn delivered by cesarean delivery. Investigators also want to explore if exposure to this Lactobacillus Reuteri alters the level of inflammation in different compartments of the mother and the infant.

The purpose of this project is to better understand the following issues:

1. How does bacteria transmit from the mother to the fetus and placenta during pregnancy and to the infant during the first 2-6 weeks after birth?
2. Does colonization of the pregnant mother and fetus/Child occur? How and when?
3. Can orally given probiotic bacteria be found in the newborn 2-6 weeks after birth, and if so where?
4. How is bacteria transported from the mother's intestinal lumen to the Child/fetus gut?
5. What impact has these bacteria on the level of inflammation in maternal and fetal compartments, especially that normally seen in the intestine of all newborns?
6. What impact has these bacteria in the bowel on a normal intestinal flora establishment?

Eligibility Criteria:
Inclusion Criteria:

* Single or multiple gestation
* Maternal age \> or = 18 y

Exclusion Criteria:

* Known structural or chromosomal fetal malformation or abnormality
* Occlusive placenta previa, placenta previa in the anterior wall of the uterus, suspicion of accreta/increta/percreta infiltration
* Unable to understand information about the study due to language or severe mental disease
* Known Hepatitis B, C, HIV
* Known immunosuppressive illness if they are under treatment
* Treatment with cytokine, methotrexate or immunosuppresses cytotoxics in the last 6 months before the study.
* Gastro-intestinal surgery including gastric bypass or huge intestinal resection.
* Anaphylactic shock
* Uterus malformation that occludes cervical Canal or uterus segment.
Multimodal Imaging Analysis, SD-OCT and OCT Angiography, Retinal Variations Observed in Dialysis Patients

Little knowledge exist on the short and long-term ophthalmological effect of the dialysis. Some studies stated a variation of the thickness subfoveal choroidal before and after a session of dialyse as well as variations of the coat of optical fibers measured in OCT.

The Optical Coherence Tomography angiography OCT is a not invasive imaging technique which is now a part of examinations of investigation in imaging of retina. This technique allows to study the retinal macula vascularization without injection of contrast agent and thus allows to deepen the knowledge in medical domains where the exploration was to limited because of the invasive character of the examinations.

The hypothesis of this project is that hemodynamic change during the hemodialysis may lead fine variations of the retinal vascularization in the short-term (the day of the dialysis) but also in the longer term (over 1 year).


Eligibility Criteria:
Inclusion Criteria:

* Indication of treatment by hemodialysis
* First session of dialysis
* Hemodialysis planned for 1 minimum year

Exclusion Criteria:

* particular ophthalmological Histories: vitreo-retinal surgery, strong nearsightedness, chronic glaucoma
* Unaffiliated in a national insurance scheme
COMPASSION S3 Post-Approval Study

This study will monitor device performance and outcomes of the SAPIEN 3 Transcatheter Heart Valve (THV) System in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted surgical valve in the pulmonic position with a clinical indication for intervention.

This is a single arm, prospective, multicenter post-approval study.

Eligibility Criteria:
Inclusion Criteria:

1. Dysfunctional RVOT conduit or previously implanted surgical valve
2. RVOT/PV with ≥ moderate regurgitation and/or a mean RVOT/PV gradient of ≥ 35 mmHg

Exclusion Criteria:

1. Inability to tolerate an anticoagulation/antiplatelet regimen
2. Active bacterial endocarditis or other active infections
A Training Software (SJ-RS-WL2015) Rehabilitating Intermittent Exotropia Binocular Functions

Evaluating the effect of SJ-RS-WL2015 visual training program in children with intermittent exotropia after eye surgery, including the improvement of simultaneous perception (I binocular function), fusion (II binocular function), stereopsis (III binocular function).

All the patients are after eye surgery for intermittent exotropia. All the participants with 20/20 or better visual acuity.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Intermittent Exotropia
* Must be after eye surgery for Intermittent Exotropia
* Baseline Deviation Range: Esotropia\<=5△ or Exotropia\<15△ after Eye Surgery
* Visual Acuity: \>=20/20

Exclusion Criteria:

* A-V patterns deviations
* Abnormal oblique or vertical rectus
* Nystagmus
* Ophthalmoplegia
* Anisometropia \>2.5D
* With other eye surgery history
* Mental disorder
* Neural disease
* Tumor
* Heart disease
* Hypertension
* Epilepsy
* Severe systemic disease
* With vision therapy history within 4 weeks
* Implanted electronic device
* In other researches within 4 weeks