cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Kaletra Therapy Over the Long-term

Long term observation of patients under lopinavir/ritonavir containing therapy

Three to five year observation of lopinavir/ritonavir therapy. Reporting groups are 1) therapy-naïve patients (144 weeks), 2) therapy-experienced but protease inhibitor naïve patients (240 weeks,) and 3) non-B subtype infected patients (240 weeks).

These three groups of participants with HIV-1 infection were at first registered as three different studies: KAL1RO (this study, NCT01083810, n=137), KAL2RO /KAL5RO (NCT01083836, n=92), and KAL6RO (NCT01081470, n=55) but were now reconciled under KAL1RO (NCT01083810) as a single study with three reporting groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients infected by HIV-1
* Age greater than or equal to 18 years

Exclusion Criteria:

* as described in SmPC (summary of product characteristics) at the time of prescription
Neurodevelopmental Assessment of Infants With Cystic Fibrosis

Infants included in the study will be divided into two groups as healthy infants and cystic fibrosis infants . Demographic, natal and postnatal information of the infants will be available from patient files. 12 months infants with cystic fibrosis and healthy infants will be assessed by the Bayley-III Baby and Child Development Assessment Scale (Bayley III) and the Gross Motor Function Measure. The assessment outcomes of healthy and cystic fibrosis infants will be compared.


Eligibility Criteria:
Inclusion Criteria:

* having diagnosis of cystic fibrosis
* to be postterm24-36 months old

Exclusion Criteria:

* Having congenital anomalies,
* Having an acute infection,
* Risk of high or low neurological impairment due to perinatal stroke, perinatal asphyxia, intra / peri-ventricular hemorrhage (IVH / PVL), bronchopulmonary dysplasia,
* The baby's family not reluctant to involved in study.
Neurotoxin and Physical Therapy

This study aims to compare Botox injections without Physical Therapy sessions to Botox injections combined with Physical Therapy sessions for treatment of Cervical Dystonia. It is expected that Botox combined with Physical Therapy will improve Cervical Dystonia symptoms and quality of life more than Botox alone. It is also expected that Botox combined with Physical Therapy will enhance neuroplasticity, or the ability of the brain to make new connections, more than Botox alone at 4-5 weeks, and remain improved at 12 weeks, after Botox injection.

The study will recruit primary cervical dystonia patients (age 18-80) who are stable on Allergan botulinum toxin type A (Botox). Patients will be randomized to receive their typical Botox injection alone, or with physical therapy.

At Baseline, disease characteristics (as measured by the Toronto Western Spasmodic Torticollis Rating Scale, or TWSTRS, and the Clinical Global Impression of Severity, or CGIS) will be measured, along with quality of life (from the Short Health 36 Survey Form 36, or SF-36). One subscale of the TWSTRS will be videotaped to be later evaluated by blinded movement disorder specialists. A pain scale will also be completed and range of head motion will be measured using a device similar to a protractor (called a goniometer). An individualized Botox injection will be administered, as well as transcranial magnetic stimulation (TMS) to measure neuroplasticity, or the ability of the brain to make new connections. If randomized to receive physical therapy, participants will also receive instructions to perform physical therapy exercises five times per week by a physical therapist who specializes in movement disorders. The investigator will call weekly to check how the participant is doing with the exercise program.

The same procedures outlined above will also be performed at 5 weeks past baseline, and at 12 weeks (except for the Botox injection, which will only be given at baseline and 12 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-80 with a diagnosis of Cervical Dystonia, which will be confirmed by a movement disorders specialist
* Positive response to at least two prior treatments with Botox as indicated by an improvement in Clinical Global Improvement Scale.
* Received last dose of Botox a minimum of 12 weeks prior to baseline visit.

Exclusion Criteria:

* Any conditions that would contraindicate transcranial magnetic stimulation (for example, pregnancy or epilepsy)
* Any secondary, fixed, post-traumatic, or psychogenic dystonia
Post Market Registry Study of Intracranial Aneurysms Treated With Sugita Clipping Devices

The objective of this study is to verify the performance and safety of the Sugita Aneurysm Clips devices when used as intended and to identify possible risk factors. Data collected will be used to support the continuing performance and safety of the devices in the post-market use environment in Europe. Subjects who have an intracranial aneurysm that the physician intends to treat with the subject devices will be included in the study. Subjects will be followup as per hospital standard of care for 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Subject has an intracranial aneurysm (ruptured or unruptured) that can be treated with one of the proposed devices.
* Subject is adult, ≥18 years.
* As per national regulations, subject or subject's legally authorized representative (LAR) has signed written informed consent.
* Subject is willing to comply with scheduled visits and examinations per institutional standard of care.

Exclusion Criteria:

* Subject is currently enrolled in or plans to be enrolled in a concurrent drug or device randomized study.
* Subject has a condition which will not allow him/her to comply with his/her post-procedure follow up per the institutional standard of care (medical condition, subject living abroad and unable to return for follow- up, e.g.).
* Subject does not meet IFU criteria of the subject device.
* Subject is a child, \<18 years.
A Comparison of Laparoscopic Cholecystectomy Versus Ultrasonic Dissection Assisted Minilaparotomy Cholecystectomy

Minilaparatomy cholecystectomy with ultrasonic dissection (UsD) is rarely considered and therefore we investigate here the contributions of UsD in early recovery.


Eligibility Criteria:
Inclusion Criteria:- Uncomplicted symptomatic cholelithiasis cholecystitis confirmed by ultrasoud

* ASA physical status 1-3
* Body mass index 18-30
* AGE 18 - 75 years

Exclusion Criteria:

* Pregnancy or lactating
* common bile-duct stones
* acute cholecystitis
* previous upper abdominal operation
* Chirrosis
* Renal disease
* Pancreatitis
* ASA 4-5
* Participation of any other clinical trial within 30 days before the start of the screening period
* History of uncontrolled cardiovascular, epileptic disorder, psychosis.
Shanghai Registry of Acute Coronary Events

SRACE is an multicenter observational database of outcomes for patients who are hospitalized with an acute coronary events. SRACE includes over 20 hospitals in Shanghai China that have enrolled a total of more than 3,000 patients since 2005, with an annual enrollment of 500 patients. The major purpose of the SRACE program is to evaluate the prognosis of patients admitted to the hospital due to acute coronary events, comparing different therapeutic strategies, in-hospital transferring system, and so on. All participating physicians receive confidential quarterly reports showing ther outcomes side-by-side with the aggregate outcomes of all participating hospitals.

consecutive patients with STEMI who presented symptoms within 12 hours and treated by primary PCI in Shanghai, were enrolled in the prospective sysytem. Several strategies were applied in these patients, including physician vs. patient transfer strategy, upsteam vs. downstream strategy, Firebird stent vs. Excel stent (bio-absorbable SES), etc. Once the patient was randomized to one of these study, he will be denied to the others. Clinical and angiographic outcomes were compared, with the final purpose to find an optimal strategy in treating AMI patients.

Eligibility Criteria:
Inclusion Criteria:

* patients admitted to the hospital with acute coronary syndrome and received medical or interventional treatment

Exclusion Criteria:

* non ACS patients;
* complicated with other lethal disease
* predicted life span less than 12 months
* known allergy history to any anti-platelet or anti-thrombin medicine
* unconscious at the time of arrival at the hospital
Primary Palliative Care for Patients With Advanced Hematologic Malignancies

This study seeks to develop and pilot-test an oncology nurse-led care management intervention to meet the primary palliative care needs of patients with advanced hematologic malignancies.

Study investigators will develop and pilot-test an oncology nurse-led care management intervention to meet the primary palliative care needs of patients with advanced hematologic malignancies.

Aim 1 is a case series to develop and refine the intervention. During this time, we will develop initial interventionist training materials, study protocols, and a web-based outcomes database; train 2 hematology-oncology nurses; enroll 10 patients with advanced hematologic malignancies and their informal caregivers to receive intervention visits; conduct debriefing interviews; iteratively refine the intervention based on nurse, oncologist, patient, and caregiver feedback; and prepare the protocol for Aim 2. Aim 2 is a pilot study to assess the feasibility and acceptability of administering the intervention and assessing outcomes. We will recruit 30 patients and their informal caregivers to receive the intervention developed in Aim 1 and collect measures of quality of life, symptom burden, anxiety and depressive symptoms, caregiver burden, and healthcare utilization at baseline and monthly for up to three months. Trial outcomes will include: rates of enrollment, study completion, and outcome completion; intervention fidelity; and self-reported measures of study burdensomeness and effectiveness among patients, caregivers, and clinicians.

Eligibility Criteria:
Participants will be (1) patients with advanced hematologic malignancies receiving care at a participating clinic; (2) their caregivers; (3) participating clinicians.

Patient:

Inclusion Criteria:

* adults (≥ 21 years old)
* Refractory or Recurrent hematologic cancer: lymphoma, leukemia, myeloma, amyloidosis (secondary manifestation myeloma \& AL Amyloidosis), and CML (CML can only be accelerated or blast phase)
* planning to receive ongoing care from a participating oncologist and willing to be seen at least monthly.

Exclusion criteria:

* chronic myeloid leukemia (CML) OTHER THAN accelerated or blast phase
* unable to read and respond to questions in English
* lacks decision-making capacity, as determined by the patient's oncologist
* unable to complete baseline interview

Caregiver

Inclusion Criteria:

* adults (≥ 21 years old)
* family member or friend of an eligible patient

Exclusion criteria:

* unable to read and respond to questions in English
* unable to complete the baseline interview (patients will be asked to select as caregiver the person who is most likely to accompany them to visits or help with their care should they need it)

Eligible clinicians will be oncology nurses and oncologists practicing at participating clinics.
Kinetics of Response of Cytomegalovirus With Ganciclovir Treatment Using Quantitative Real-Time PCR

The overall purpose of this research is to develop and use a blood test to better understand how quickly the viral drug ganciclovir works to clear infection with the CMV virus (Cytomegalovirus) when it occurs. This test will potentially let doctors know early in the course of therapy when a virus is not responding well to the therapy and could therefore be resistant to the drug. The target population of this study will be primarily kidney and lung transplant patients with CMV detected in the blood, although other patients may also be included if they meet criteria. The study will be divided into two phases. Phase I will evaluate a small number of exploratory patients initiating ganciclovir therapy and will require frequent blood sampling to obtain detailed information regarding the kinetic response of the virus to therapy. This information will be analyzed to help guide decisions regarding the number and frequency of blood samples needed in the larger phase II portion of the study. Strains will be characterized using phenotypic and genotypic methods to determine the presence or absence of mutations potentially responsible for the resistance.


Eligibility Criteria:
Inclusion Criteria:

* Patients affiliated with Barnes-Jewish Hospital with CMV blood infection requiring antiviral therapy
* All patients will have a positive qualitative CMV PCR or viral culture before starting therapy
* Patients will receive treatment with ganciclovir at a dose and duration to be determined by the provider
* It is anticipated that most subjects will be organ transplant recipients but this is not a requirement of the study

Exclusion Criteria:

* Critically ill patients
* Patients with profound leukopenia or abnormal renal function that make a change in the antiviral drug dosage likely during the duration of the study
* Anemia (HGB \< 8 g/dl) that would contraindicate the extra blood draws required by this study
* Problems with vascular access that would interfere with obtaining blood samples required by this study
* Residence outside of the St. Louis metropolitan area during the period of ganciclovir therapy
* Patients who are unable to provide informed consent because of diminished capacity related to illness, dementia, or other reasons
Ambulatory Versus Home Blood Pressure Measurement

This is a prospective study comparing the three blood pressure monitoring methods on the diagnosis of arterial hypertension. Blood pressure of each subject will be evaluated with clinic, home and 24h ambulatory blood pressure measurements in three visits


Eligibility Criteria:
Inclusion Criteria:

* Age \> 20 yrs
* Patients referred to an outpatient clinic for high blood pressure
* Patients with no treatment or with antihypertensive treatment stable for at least 4 weeks.
* Patients capable of performing home blood pressure measurements.
* Signed informed consent

Exclusion Criteria:

* Hypertension stage III (SBP\>180 mmHg or DBP\>110mmHg)
* Secondary hypertension
* Resistant hypertension
* Arrhythmia
* Pregnancy
* Symptomatic heart disease
* Renal disease (Cr\>2mg/dl)
* Uncontrolled diabetes mellitus (HbA1c\>8.5%)
Efficacy and Safety Evaluation of Vi-sealer

This study's primary goal is to compare the efficacy and safety of the novel advanced hemostatic device(AHD), Vi-Sealer, with conventional AHDs in laparoscopic total hysterectomy for patients with benign gynecologic neoplasm.

Vi-Sealer is a reusable advanced bipolar electrode with an interchangeable blade. This study evaluates the efficacy and safety of the Vi-Sealer by comparing it with other advanced hemostatic devices, such as Ligasure, Enseal, Thunderbeat, Harmonic scalpel, etc. The economic evaluation of the device compared with other disposable devices would also be conducted.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 20 to 65 years
2. Clinically diagnosed with benign gynecologic neoplasms (eg. adenomyosis, uterine fibroids, etc.)
3. Eligible for hysterectomy
4. Signing an written consent form indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study prior to any other study-related assessments or procedure

Exclusion Criteria:

1. Large uterus size over 16 weeks of gestational age
2. Cervical or intraligamentary fibroids
3. Severe endometriosis (stage 3 or 4)
4. Suspected malignancy of the uterus or adnexa
5. Contraindicated for the use of energy devices (such as implantable cardioverter defibrillators, pacemakers)
6. Previous pelvic surgery ≥ 3 times
7. Not suitable for laparoscopic surgery
Samu Save Sepsis: Early Goal Directed Therapy in Pre Hospital Care of Patients With Severe Sepsis and/or Septic Shock

The purpose of this study is to determine whether an aggressive strategy of severe sepsis patients since pre hospital care, including early antibiotics administration, hemodynamic optimization, and opotherapy when indicated, could reduce mortality

Major prognostic factor in sepsis management is rapidity of treatments implementation. In 2001, Rivers observed a reduction in mortality through early hemodynamic optimization. In 2009, Arnold emphasizes that establishing more early antibiotic therapy allowed a further reduction of mortality.

In France, pre hospital care is based on mobile intensive care unit (MICU) called SMUR. SMUR is consisting of a driver, a nurse and an emergency physician.

Actually in France, management of severe septic syndrome (severe sepsis and septic shock) are not standardized and based on a "conventional" strategy at the discretion of the emergency physician. Antibiotics are given in only two cases: fulminans purpura and meningitis. Hemodynamic optimization is not a standard of care and no recommendation exist for hemodynamic targets.

An "aggressive" strategy based on early antibiotics administration, hemodynamic optimization and opotherapy when required could be initiated by SMUR since first contact with the patient before hospital admission.

We assume that an "aggressive" strategy initiated during the first 60 minutes of prehospital stage compared to "conventional" strategy could allow to reduce mortality in severe sepsis patients.

Eligibility Criteria:
Inclusion Criteria:

All patients fulfilling the following criteria:

* Age ≥ 18 years
* Patient with suspected severe infection defined by the existence of a suspected infection AND

  * Hypotension before vascular fluid loading AND/OR
  * Lactataemia greater than 4 mmol/l AND/OR
  * Glasgow scale lower than 13 AND/OR
  * Mottling score greater than 2
* Patient with a septic shock

Exclusion Criteria:

* Age \<18 years or Unable
* Pregnant
* Severe concomitant pathology requiring urgent care(i.e.epilepsy)
* Status "not to be reanimated" life expectancy less than 6 months with no indication of reanimation support ( prior decision on care limitation).
* Fulminans purpura
* True allergy to beta-lactam defined by an angioedema or by an anaphylactic shock during a prior exposure to beta-lactam.
* Patient who have already received hemodynamic optimization or antibiotic treatment before the MICU's (Mobile Intensive Care Unit) care.
Functional Assessment of the Infart-related Artery With Bioactive and Polymer-free Coronary Stents (The FUNCOMBO Trial)

A total of 50 patients with ST-elevation myocardial infarction (STEMI) undergoing primary-percutaneous coronary intervention (PPCI) will be randomized to two different coronary stents: BIOFREEDOM vs. COMBO stent.

All patients will undergo to 6-month scheduled coronary angiography to evaluate the endothelial function response of the distal coronary segment and other functional parameters.

The bioengineered COMBO stent (Orbus Neich, Fort Lauderdale, Florida, United States) has a dual-therapy strategy, which combines a sirolimus-eluting coating with an anti-CD34 antibody layer to promote vessel healing. Sirolimus release (5 μg/mm) is completed in 30 days, and the biodegradable polymer disappears within 90 days.

CD34 antibodies are immobilized on the surface of the stent and capture circulating endothelial progenitor cells (EPCs). The captured EPCs are triggered by sheer stress from the circulating blood and other cell signals to differentiate and mature into endothelial cells. COMBO Plus is the only stent with a biological coating that actively repairs the vessel morphology. However, little is known regarding the endothelial function after stent implantation.

Eligibility Criteria:
Inclusion Criteria:

* STEMI \< 12 hours undergoing primary PCI.
* ST-segment elevation of \> 1mm in \> 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of \>1mm in \>2 contiguous anterior leads.
* Presence of at least one acute infarct artery target vessel with one or more de-novo coronary artery stenosis in a native coronary artery within 2.75 - 3.75 mm reference vessel diameter and \< 24 mm length (visually estimated).

Exclusion Criteria:

* Inability to provide informed consent
* Female of childbearing potential (age \<50 years and last menstruation within the last 12 months), who did not undergo tubal ligation, ovariectomy or hysterectomy
* Known intolerance to aspirin, heparin, PLLA, everolimus, contrast material
* Cardiogenic Shock
* Unprotected left main coronary artery stenosis
* Distal occlusion of target vessel
* Acute myocardial infarction secondary to stent thrombosis
* Mechanical complications of acute myocardial infarction
* Severe tortuous, calcified or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal imaging or excessive risk of complication in the follow-up procedure
* Active bleeding or coagulopathy or patients at chronic anticoagulation therapy
* Chronic renal dysfunction with creatinine clearance \< 45 ml/minm2
* Subject is currently participating in another clinical trial that has not yet completed its primary endpoint
An Intervention to Improve Nutrition and Physical Activity in Preschoolers in Cuenca, Ecuador

The aim of this study is to design and evaluate an educational and behavioral intervention focused on improving nutrition and physical activity habits among preschoolers in Cuenca, Ecuador, with the overarching goal of preventing overweight/obesity and promoting the formation of healthy nutrition/physical activity habits.

In Ecuador and in the city of Cuenca, the prevalence of obesity is high (approximately 22% of the population). Simultaneously, there is high prevalence of chronic malnutrition (e.g., stunting). In a previous study in school-aged children in Cuenca, the prevalence of overweight or obese was 30%.

The objective of this study is to design an intervention to improve nutrition and physical activity habits and behaviors in preschoolers. The study will begin with a baseline survey that will be used to develop the educational and behavioral intervention. The intervention will consist of didactic material for teachers, educational material for parents, and activities for the children. The investigators will carry out the intervention over the course of the school year. The intervention will be primarily delivered in the preschool setting, but will also include workshops for parents.

The investigators hope that this study will help promote the health of children in Cuenca and can be a pilot study to test similar interventions in larger populations in Ecuador.

Eligibility Criteria:
Inclusion Criteria:

Any child attending a preschool of the municipality

Exclusion Criteria:

Any child whose parents decline inclusion in the study