cyrilzakka/clinical-trials huggingface dataset:
A Phase I, Open Label Dose Escalation Study to Evaluate Safety of iHIVARNA-01 in Chronically HIV-infected Patients Under Stable Combined Antiretroviral Therapy

The mai purpose of the study is to evaluate the safety and to establish the recommended dose of iHIVARNA-01 as a new therapeutic vaccine against HIV


Eligibility Criteria:
Inclusion Criteria:

1. Patient is ≥ 18 years of age
2. Voluntarily signed informed consent
3. Patient is male, or female with negative pregnancy test prior to enrolment
4. Patient has a proven HIV-1 infection (with positive antibodies against HIV-1 and a detectable plasma HIV-1 RNA before cART)
5. Patient must be on stable treatment with cART for at least 6 months (cART is defined as an antiretroviral regimen consisting of at least three registered antiretroviral agents)
6. Nadir CD4+ cell counts must be above or equal to 350 cells/μl (1 or 2 occasional determinations below 350 will be allowed)
7. Current CD4+ cell count must be at least 450 cells/μl
8. HIV-RNA must be below 50 copies/ mL for the last 6 months prior to inclusion, during at least two measurements (occasional so called 'blips' up to 50 copies/mL are permitted)

Exclusion Criteria:

1. Treatment with a non-cART regimen of antiretroviral agents prior to the start of cART;
2. History of a CDC class C event (see Appendix V);
3. Patient is female and has a positive pregnancy test or the wish of pregnancy:
4. Active opportunistic infection, or any active infection or malignancy within 30 days prior to screening visit;
5. Therapy with immunomodulatory agents, including cytokines (e.g. IL2) and gamma globulin, or cytostatic chemotherapy within 90 days prior to screening visit;
6. Use of anti-coagulant medication;
7. Use of any investigational drug during the 90 days prior to study entry;
8. Previous failure to antiretroviral and/or mutations conferring genotypic resistance to antiretroviral therapy EudraCT No. 2014-004591-32 33 Protocol version 1.1, dated 10 February 2015
9. Any other condition which, in the opinion of the investigator, may interfere with the evaluation of the study objectives.
10. Active hepatitis C virus or hepatitis B virus co-infection
11. Non-subtype B HIV infection
Case Management - Active Telephone Support to Patients With COLD

To investigate the effects of patient counseling by telephone on Quality of Life and the use of Health care system.

By analyzing patient data, patients with risk of high consumption of the Health system are identified.

These patients are invited to take part in the study. If the patient accept the invitation, oral and written information of the study is given. If the patient give informed consent to participate, the inclusion and exclusion criteria and the patient record are examined.

If the patient meet the criteria the patient is randomized to active treatment or control 1:1.

Patient in the Intervention Group have a in depth interview of Health and social status and possible interventions are planned. Following that, the patient is contacted by telephone on weekly intervals for 6 to 9 months.

Patients in both Groups fill out questionaire Short-Form Health Survey-36 (SF-36) and COPD Assessment Test (COPD) and the consumption of Health care is monitored.

Eligibility Criteria:
Inclusion Criteria:

* Patient living in The Zealand Region.
* A COLD-related contact with hospital with-in 6 months.
* Predicted to be in high risk of new hospital admission.

Exclusion Criteria:

* Dementia.
* Psychosis.
* Drug-addiction.
* Cancer with metastasis.
* Terminal illness.
* Language difficulties demanding translator.
The Effect of Mandala Activity-Based Breastfeeding Program on Breastfeeding Self-Efficacy and Maternal-Infant Attachment of Primiparous Mothers

This study will be conducted to determine the effect of breastfeeding program integrated with art therapy such as mandala painting on postpartum breastfeeding self-efficacy, breastfeeding rates, and mother-infant attachment of primiparous mothers.

Training on breastfeeding and mother-baby bonding and mandala drawings supporting the training will be sent online to primiparous pregnant women who are at 32-36 weeks of gestation and agree to participate in the study. Telephone follow-up and counseling will continue in the postpartum period. In the postpartum period, follow-up and counseling will continue until the second month.

In this study, a mandala-based breastfeeding program will be applied to primiparous mothers at 32-36 weeks of gestation. The study will be conducted to determine the effect of mandala-based breastfeeding programs on postpartum breastfeeding self-efficacy, breastfeeding rates, and maternal-infant attachment of primiparous mothers. Training on breastfeeding and mother-baby bonding and mandala drawings supporting training will be sent online to primiparous pregnant women who are at 32-36 weeks of gestation and agree to participate in the study. The study is planned to be conducted with 72 pregnant women (intervention group=36, control group=36). Telephone follow-up and counseling will continue in the postpartum period. In the postpartum period, follow-up and counseling will continue until the second month.

Eligibility Criteria:
Inclusion Criteria:

* Primiparous pregnancy,
* Being at 32-33 weeks of gestation,
* Being over 18 years old,
* To be at least a primary school graduate,
* Owning a phone,
* Having internet access at home or at work,
* Using the internet,
* Being able to speak Turkish,
* Mothers who agreed to participate in the study

For infants;

* Born at 37-42 weeks of gestation,
* Birth weight between 2500-4000 g,
* Infants without any health problems or congenital anomalies were included in the study.

Exclusion Criteria:

* pregnant women and infants with health problems
The Evaluation of the Lower Limb Function After Femur Fracture's Operation Treatment

The goal of this study is the evaluation of lower limb function and the quaility of life of the patients after femur fracture operation treatment. LLTQ (Lower-Limb Tasks Questionnaire), LEFS (Lower Extremity Funcional Scale), LLFI-10 (Lower Limb Functional Index - 10) and LLFI (Lower Limb Functional Index) will be used for all the patients.

All four questionnaires (LLTQ, LEFS LLFI-10 and LLFI) will be translated and adopted to the Polish conditions. The detailed medical/ epidemiological history will be collected in each patient. The fracture will be assessed based on the x-ray examination and will be qualified according to AO classification. NRS (Numerical Rating Scale) will be used to assess the pain intensity. SF36, QoL, CSQ, COPE and HADS questionnaire will be used to evaluate patient's the quality of life (subjective assessment). First assessment will be done before operation and then after 3, 6, 12, 24 month postoperation treatment.

With this main study, there is a plan to assess not only femur fractures patients, but the investigators would like to have addtional groups of the patients with hip and knee allopasty and knee arthroscopy with slightly different follow-up period: before the oparation, 1 and 12 month after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* Signed Patient Informed Consent
* Patients planned for the surgical treatment

Exclusion Criteria: n.a.
E-health Care Process Support for Diabetes Type II Patients

The purpose of the study is to clinically evaluate a new approach to treatment of patients with diabetes mellitus type II by using specially developed mobile-internet software solution.

The effect of information and communication technologies (ICT) to improve the integrated care of people with diabetes will be identified, developed, introduced and clinically evaluated.

The investigators expect that usage of an e-Health application in health care of patients with diabetes mellitus type II could improve the following healthcare outcomes: results of the laboratory tests (with emphasis on HbA1C value), regular medication usage, blood pressure values, Body mass index (BMI) values, diet, regular exercise and quality of life.

Diabetes mellitus (DM) is defined as a "group of common metabolic disorders that share the phenotype of hyperglycemia". It is generally agreed that in Caucasian populations the prevalence rate is between 2% and 6%. Prevalence rate of DM in SLovenia is about 5%. Type 2 DM accounts for 90% to 95% of all diabetes cases.

Results of many clinical studies demonstrated the great potential of information and communication technology (ICT) applications to improve health care of patients with chronic diseases including diabetes mellitus.

In this study an ICT mobile environment to improve the process of an integrated care of people with Diabetes mellitus will be identified, developed, introduced and clinically evaluated. The study will include 140 patients diagnosed with diabetes mellitus type II who are managed in primary care. The study will use and evaluation questionnaire that will cover issues regarding the patient quality of life.

Subjects with a blood pressure meter and a scale, will be able to enter the value of the systolic and diastolic blood pressure and the body weight.

Subjects will be motivated to regularly enter data about their blood pressure, body weight, dietary misconducts and to complete available questioners. In addition to this, users can enter values about their physical activity (type, duration, intensity).

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes, treated with non-pharmacological interventions or/and tablets (Non-Insulin-Dependent Diabetes Mellitus)
* Internet connection and personal computer /lap-top computer
* Mobile phone
* Sufficient level of Internet and e-mail usage - checked by short questionnaire
* Age \>18 or \<75 years

Exclusion Criteria:

* significant co-morbidity
* Type 1 diabetes
* Insulin-dependent type 2 diabetes
Assessment of Hemodynamic Response in Surgery of Circumcision in Children

The surgery stress relives systemic inflammatory response by hormones and adrenergic receptors. When the pro-inflammatory mediator is higher than anti-inflammatory response, the physiologic status is impaired and the patient is more susceptible an infection and cardiovascular collapse. The anesthesia can abolish or minimize the surgery stress, improved more safety to the patient.

This study is a double blind controlled trial with 40 patients divided in two groups (EMLA and Dorsal Penile Nerve Block - DPNB) submitted a standard inhalator anesthesia and postectomy surgery by Plastbell®. The investigators will be observe heart rate, respiratory rate, arterial pressure, involuntary movements during the surgery and pain in the pos-operatory.

With this study, the investigators can define what tactic (EMLA or DPNB) associated a general anesthesia is more effective to relive the pain when children are submitted a postectomy by Plastbell®.


Eligibility Criteria:
Inclusion Criteria:

ASA status physical 1 children between 3 and 13 years old

Exclusion Criteria:

* parents don't accept the study classic circumcision
High Dose Therapy and Peripheral Blood Stem Cell Transplantation in HIV Related Non Hodgkin Lymphoma (NHL) at High Risk

The purpose of the study is to evaluate the efficacy of an intensified first-line treatment, with conventional chemotherapy (CHOP) plus monoclonal antibody anti CD20, followed by high dose chemotherapy and PBSC transplantation in HIV-related aggressive non-Hodgkin lymphoma at "high risk" , according to the international prognostic index (IPI).

HIV associated NHL show particularly aggressive clinical features and a worse prognosis compared to the general population. The recent introduction of highly active antiretroviral therapy (HAART)has improved HIV positive patients' clinical conditions and reduced the risk of opportunistic infections, thus making HIV+ patients more similar to HIV- patients. Several studies have shown that the early use (as first line treatment) of high dose chemotherapy (HDT) with peripheral blood stem cell transplantation (PBSCT) is superior in the HIV negative setting to conventional dose chemotherapy, at least in patients with poor prognostic factors at diagnosis. Recently, several experiences have shown the feasibility, safety and efficacy of HDT and PBSCT, in association with HAART, as salvage therapy in HIV positive patients with lymphoma who maintain a chemosensitive disease after first-line treatment failure. It is rationale therefore to explore the use of this treatment strategy earlier, within the upfront treatment of HIV-associated lymphoma, in those patients with poor prognostic factors at diagnosis, according to the international prognostic score (IPI).

Eligibility Criteria:
Inclusion Criteria:

* HIV positivity
* "Large cell"histology (DLBCL, Immunoblastic, Plasmablastic, Anaplastic lymphoma)
* Age 18-60 years
* Age-adjusted IPI 2-3
* Ann Arbor stage I B-IV
* Written informed consent.

Exclusion Criteria:

* Burkitt lymphoma
* Lymphoblastic lymphoma
* Primary effusion lymphoma
* Age-adjusted IPI 0-1
* Performance Status (WHO) \>2 (if not related to lymphoma)
* Inadequate cardiac function (V.E.F. \< 50%) or clinically evident cardiac disease
* Inadequate pulmonary function (DLCO \< 50% and/or O2 \< 96%)
* Inadequate renal function (creatinine \> 2 mg/dl)
* Inadequate liver function (AST/ALT \> 3 ULN and/or PT \< 70%, if not related to lymphoma)
* Inadequate marrow function (neutrophils \< 1500/cmm; platelets \< 100.000/cmm, if not related to lymphoma)
* Virologic failure to HAART (including at least one NRTI, one NNRTI and two PI) and/or CD4 count \< 50/cmm.
* CNS or meningeal lymphoma
* Active opportunistic infections
* Pregnancy
* Other evolutive malignancy (except of localized non-melanoma skin cancer and in situ portio carcinoma)
* Any other condition that contraindicates this treatment program at discretion of physician
* HBsAg positivity with active viral replication (HBV-DNA positivity)
A Retrospective Study of the Effects of Molecular Diagnostics on Wound Care Outcomes

A retrospective molecular diagnostic review on wound care outcomes between two time periods. The time periods include June, July, August of 2008 and June, July, August of 2009. The retrospective review would analyze the days of healing during those two timeframes, upon the introduction of molecular diagnostic testing.


Eligibility Criteria:
Inclusion Criteria:

* A patient record captured during June, July, August 2008 and June, July, or August of 2009.

Exclusion Criteria:

* A patient record captured outside the time frame of June, July August 2008 or June, July, August of 2009.
Statin and Post-interventional Coronary Microcirculation Dysfunction

The purpose of this study is to evaluate the effect of statin on the coronary microcirculation dysfunction measured after percutaneous coronary intervention.

Development of peri-procedural myocardial infarction following percutaneous coronary intervention (PCI) is not uncommon and affects long-term prognosis. Clinical studies have shown that pre-treatment with atorvastatin reduced peri-procedural myocardial infarction in patients with stable angina. The mechanism of peri-procedural myocardial infarction is presumed to be microvascular embolization. However the direct causal relationship between statin pretreatment and prevention of microvascular dysfunction has not been investigated yet.

In this study, we will recruit symptomatic angina patients who have clinical indication of coronary angiography. At the time of enrollment, patients will be randomly assigned to pre-treatment group (atorvastatin 80 mg/d for 4 days) or control group. Percutaneous coronary intervention (PCI) will be perfomed based on the result of diagnostic coronary angiography by decision of attending physician. When PCI is performed, fractional flow reserve (FFR) and index of microvascular resistance (IMR) will be measured before and after the procedure. Periprocedural myocardial infarction will be defined by post-PCI cardiac biomarker. All patients will be followed for adverse cardiac events for 1 year.

Eligibility Criteria:
Inclusion Criteria:

* A. Finished informed consent
* B. Stable angina with clinical indication of coronary angiography
* C. Age ≥ 21 year and ≤ 80 year

Exclusion Criteria:

* A.Without informed consent
* B.PCI target lesion is not adequate or not indicated for FFR/IMR study
* C.Prior myocardial infarction or interventional procedure for PCI target vessel
* D.Myocardial infarction within 30 days
* E.Usage of statin, current or within 1 month
* F.Prior bypass surgery
* G.Impaired renal function (Creatinine \> 2.0 mg/dL)
* H.Impaired left ventricular function (ejection fraction \< 40%)
* I.Active hepatitis or abnormal hepatic transaminase level (\> 3 ULN)
* J.Contraindication for long-term antiplatelet agent or statin
* K.Planning or potential of pregnancy
* L.Neoplastic disease without evidence of treatment completion
* M.Impaired general condition
A Study of the Implementation of an Electronic Consultation ("eConsult") Platform

The purpose of this study is to evaluate the implementation of an electronic consultation model for specialty services (eConsults) to improve quality of care and reduce health system costs. An eConsult is a non-face-to-face consultation between a primary care provider and a specialist that takes place via secure messaging.

The study is a randomized, controlled trial where the intervention is the evidence-based eConsult model in which consults are submitted by electronic, secure messaging to a specialist for review and "virtual" consultation. Primary Care Providers will be randomized to the control or intervention group. In the intervention group, ALL new, non urgent, adult cardiology referrals will be submitted to the eConsult Cardiology team for an eConsult. Consults for children (age \<18) and consults for patients who already have an established relationship with another cardiologist will not be eligible for an eConsult. Urgent consults, such as those for patients with active chest pain or other acute conditions, will not be submitted for eConsult and should instead be handled by the on-site care team as per the standard protocol. For eConsults, the consult will be submitted using the eConsult pathway within the electronic health record. eConsults will be created in the same way that standard referrals are created, with attachment of a treatment summary, EKG, relevant results, and specification of the consultative question. The eConsult will be received by the intervention Cardiology team and reviewed within 2 business days. One cardiologist per day will be assigned to review and respond to eConsults.

The result will be received by the primary care provider who will be responsible for acting appropriately on the cardiologist's recommendations. Recommendations will be case specific and may include one of three broad areas of suggestion: 1) suggestions for ongoing management by the primary care provider, 2) suggestions for additional testing in advance of a cardiology face to face appointment or to better determine a next course of action, and 3) immediate cardiology referral.

For each of these options, the primary care provider will be responsible for following up and implementing the recommendations made by the Cardiologist. When referral is recommended the primary care provider will refer the patient to the cardiologist of their choice based on their location and the patient's preference. While not required, they may refer the patient to the eConsult cardiology team at University of Connecticut for face to face care if desirable, but may also refer to other Cardiologists. The intervention will last one year. Providers randomized to the control group will provide standard care which involves a traditional referral for an in-person cardiology visit.

Eligibility Criteria:
Inclusion Criteria:

* Primary Care Provider at Community Health Center, Inc who work at least 30 hours per week and see adult patients

Exclusion Criteria:

-
Lipid Efficacy Study (0524B-022)(COMPLETED)

This is a 12-week clinical trial in patients with primary hypercholesterolemia or mixed hyperlipidemia, studying the effects of coadministered MK0524B on lipids. There will be 6 scheduled clinic visits, and 7 treatment arms.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 to 85 years of age with primary hypercholesterolemia or mixed hyperlipidemia
* LDL-C between 130 and 190 mg/L (Category I) and 130 and 160 mg/L (Category II) and triglycerides \</= 350 mg/dL.

Exclusion Criteria:

* A condition which, in the opinion of the investigator, might pose a risk to the patient or interfere with participating in the study
* Patients with \<80% compliance
* Patients with certain medical conditions
* Patients taking certain concomitant medications and/or with unstable doses of medications
* Or those with a history of CHD/CHD equivalent or diabetes
Does Laparoscopic Sleeve Gastrectomy Lead to Barrett's Esophagus, 5-year Esophagogastroduodenoscopy Findings: A Retrospective Cohort Study

Introduction Laparoscopic Sleeve Gastrectomy (LSG) is one of the most prevalent approaches to tackle obesity and its co-morbidities. The main complication following the LSG is Gastro-esophageal reflux disease (GERD), with most patients developing worsening symptoms of GERD, and a small number progressing to Barrett's esophagus. This retrospective analysis aims to assess the rate of GERD pre- and post- LSG as well as the rate of progression to Barrett's.

Methods Data was collected from 1639 patients. 92 patients fit our inclusion criteria. Data was then analyzed and summarized against similar literature


Eligibility Criteria:
Inclusion Criteria:

* patients eligible to sleeve gastrectomy that had an EGD pre and 5 years post-op

Exclusion Criteria:

* missing or implausible data, had multiple surgeries, and suffered from the common post-sleeve complications, such as leaks, strictures and hiatal hernias
Robotic Trans-Abdominal Retromuscular Umbilical Prosthesis (r-TARUP)

Combining the advantage of minimally invasive surgery with laparoscopy to reduce postoperative complications and the placement of a retromuscular prosthesis with closure of the defect in order to reduce the risk of adhesion and restore normal anatomy in the treatment of primary and incisional ventral hernias, is made possible through robotic assistance.

The challenge of this study concerns the evaluation of quality of life, postoperative pain and recurrence at 6 months in the management of primary and incisional ventral hernias by robot-assisted laparoscopic approach.

The robotic-assisted laparoscopic approach for the treatment of primary and secondary ventral hernias is already used in the visceral department of Nancy in France. This technique seems to reduce post operative pain, to improve quality of live and to reduce recurrence. The goal of the study is to evaluate the benefices of this technique. The quality of life, postoperative pain and recurrence will be evaluated at one and six months postoperatively. The recurrence will be evaluated by clinical examination and a computed tomography scan performed at sixth month postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* major patients undergoing a robotic-assisted laparoscopy procedure for the treatment of ventral hernia repair

Exclusion Criteria:

* patient minor