cyrilzakka/clinical-trials huggingface dataset:
Minimally Invasive Surgery of the Hip Versus Standard Approach

The purpose of this study is to determine if there is a difference in terms of length of hospital stay and post-operative outcomes between patients whose total hip replacement surgery is performed with a minimally invasive versus standard surgical approach.

Traditional techniques for total hip arthroplasty (THA) require complete visualization of the acetabulum and proximal femur since anatomic landmarks are crucial for correct orientation of the prosthetic components. All surgeons are taught that a wide surgical exposure is one of the most important factors in performing successful THA. Traditionally, it was impossible to achieve accurate fixation and orientation of the components without complete visualization of bony landmarks. These extensile exposures facilitate accurate implant alignment, but at the expense of more extensive soft tissue dissection. Little clinical research has been undertaken to relate the surgical approach to postoperative complications or patient function. Furthermore, despite the good overall results of THA, the recovery time to improved function can be lengthy. Blood loss is expected to be directly related to the extent of the surgical exposure and to influence patients outcomes. Based upon these facts, an important principle of arthroplasty surgery is to minimize the amount of soft tissue trauma while being able to achieve the surgical goal of reconstructing the arthritic hip joint. By definition, minimally invasive surgical (MIS) procedures result in less soft tissue disruption, which in turn should reduce pain, expedite healing, decrease recovery time, and potentially reduce the number of associated complications.

Eligibility Criteria:
Inclusion Criteria:

BMI \> 30 kg/m2 No prior ipsilateral hip surgery Osteoarthritis

Exclusion Criteria:

Patients with grossly distorted bony anatomy whereby standard implants are contraindicated; i.e. congenital dysplasia of the hip, proximal femoral abnormalities, etc

Rheumatoid Arthritis
Exploration of the Parameters Influencing the Effort Limitation of Patients Suffering From Homozygous Sickle Cell Anemia

The cardiovascular complications of sickle cell disease are associated with major morbidity and mortality, as well as impaired quality of life. Stratifying the cardiovascular risk of these patients solely on resting parameters (blood pressure, cardiac ultrasound) is limited. The hypothesis that an exhaustive analysis of the physiological parameters of exercise is launched allows more relevant phenotyping and therefore much better stratification of the individual risk of these patients..

Recent studies have shown a paradigm shift in the use of physical activity. Hitherto inadvisable (acidosis, vaso-occlusive crises), if adapted, moderate and regular, it can lead to functional improvement and a reduction in crises. As a result, cardiovascular exercise rehabilitation is becoming increasingly popular in this population.

It's easy to see how effort assessment, particularly through cardiorespiratory exchanges, will become more common in this pathology, making its analysis accessible and interesting.

The cardiovascular complications of sickle cell disease are associated with major morbidity and mortality, as well as impaired quality of life. Stratifying the cardiovascular risk of these patients solely on resting parameters (blood pressure, cardiac ultrasound) is limited. The hypothesis that an exhaustive analysis of the physiological parameters of exercise is launched allows more relevant phenotyping and therefore much better stratification of the individual risk of these patients.

Recent studies have shown a paradigm shift in the use of physical activity. Hitherto inadvisable (acidosis, vaso-occlusive crises), if adapted, moderate and regular, it can lead to functional improvement and a reduction in crises. As a result, cardiovascular exercise rehabilitation is becoming increasingly popular in this population.

It's easy to see how effort assessment, particularly through cardiorespiratory exchanges, will become more common in this pathology, making its analysis accessible and interesting.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient ≥ 18 years old
* Affiliated with a social security scheme (beneficiary or beneficiary's beneficiary)

Exclusion Criteria:

* Pregnant or breast-feeding women
* Patients under guardianship, curatorship or legal protection
* Patient under AME
* Patient with a contraindication or unsuitability for physical activity on a cycloergometer
Cognitive Behavioral Therapy for Mechanical Ventilation Wean

The purpose of this study is to use CBT strategies in assisting patients hospitalized in intensive care units in ventilation wean through a case series of 2 patients.

Approximately a third of patients in intensive care are mechanically ventilated. The current weaning standard of care leaves much to be desired in both patient anxiety and time to wean. Cognitive behavioral therapy (CBT) is the gold standard treatment for anxiety. The purpose of this study is to use CBT strategies in assisting patients hospitalized in intensive care units in ventilation wean through a case series of 2 patients.

Eligibility Criteria:
Inclusion Criteria:

* Receiving mechanical ventilation and Failed 3 spontaneous breathing trials

Exclusion Criteria:

* Delirium
Health Coaching for Glaucoma Patients

The study will be conducted to examine the feasibility of using a Health Coach for improving the ophthalmic care of glaucoma patients. Patients taking glaucoma medications will have a coaching intervention and adherence to glaucoma drops will be monitored using a dose-recording device. The dosing data will be analyzed to examine the effect on adherence and qualitative interviews at the conclusion of the study will be used to examine which elements of the coaching experience were most helpful in the glaucoma patient population.

Glaucoma medication adherence will be tracked using a dose recording device to record eye drop usage.

Eligibility Criteria:
Inclusion Criteria:

* Adult whose age is \>18 years
* Diagnosed with glaucoma
* Patient of Duke Glaucoma Service
* Prescribed or using topical glaucoma eye medication for at least 6 months
* Primarily self-administering his or her eye drops
* English speaking
* Patient should be able to use the telephone for the coaching intervention,
* Patient should be available by phone to complete the coaching intervention
* Patient should be willing and able to use the MEMS (Medication Event Monitoring System) device for recording medication use
* Patient must be willing and able to come to the Eye Center for an exit interview and to return the MEMS device
* Patient must be able to give consent

Exclusion Criteria:

* Patient should be excluded if he or she may need glaucoma surgery or laser during the 6 months of the study period
Everyday Activity Supports You (EASY) Pilot Study

The investigators propose a 6-month, parallel, single-blind randomized controlled trial (RCT) feasibility study of a self-management program to reduce sedentary time and increase physical activity (Sit Less to Move More) in women aged 55-70 years. The primary aim is to determine feasibility and acceptability of the intervention; and the secondary aim is to test the effect of the intervention on the primary health outcome, physical activity (mean daily step count by accelerometry) at 6 months. The investigators will also conduct an economic evaluation and a process evaluation to guide a future larger study and to inform a scaled-up implementation plan.


Eligibility Criteria:
Inclusion Criteria:

* Healthy community-dwelling women aged 55-70 years who (via self-report) are not currently engaging (or in the previous 3 months) in any strength training, or \<30 minutes brisk walking or moderate exercise/week
* are able to climb stairs and walk 400 meters (e.g., do not have a mobility disability).

Exclusion Criteria:

* Participants who receive treatment for medical conditions that preclude participation in a walking program
Levetiracetam to Prevent Post-Traumatic Epilepsy

Head injury is the cause of approximately 5% of all epilepsy in the US. Past attempts at preventing epilepsy by treatment with older antiepileptic drugs have been unsuccessful. Levetiracetam is a novel AED with potent antiepileptogenic properties in animal models of epilepsy. It has a favorable side effect and pharmacokinetic profile. It is therefore a strong candidate for a clinical trial of epilepsy prevention following traumatic brain injury (TBI). However, there has been no experience in administering levetiracetam rapidly to individuals with acute TBI. The investigators propose to initiate the evaluation of levetiracetam in prevention of post-traumatic epilepsy by determining the safety, tolerability, pharmacokinetics and feasibility of acute and chronic administration of levetiracetam to individuals with head injury with a high risk for developing post-traumatic epilepsy. Further, the investigators will follow subjects for 2 years after injury in order to obtain pilot data about effect of levetiracetam on PTE. This pilot study is the first step in evaluation of levetiracetam in prevention of post-traumatic epilepsy.


Eligibility Criteria:
Inclusion Criteria:

* Acute head injury associated with one of the following:

Intracranial hemorrhage, including epidural, subdural and intracerebral hemorrhage or with cerebral contusion(s) of any size; Penetrating (foreign body) head injury; Skull fracture and dural tear; Seizure within 8 hours of head injury

* Onset of head injury within 8-hours of proposed treatment initiation.
* Glasgow Coma Scale 6-15.

Exclusion Criteria:

* Clinical contraindications:

  * Previous epilepsy or status epilepticus.
  * Any systemic illness or unstable medical condition that might pose additional risk, including: renal insufficiency, other unstable metabolic or endocrine disturbances, and active systemic cancer.
  * Psychosis within six months of enrollment as determined by history of hospitalization for psychosis or medications for psychosis.
  * Moderate to severe mental retardation (IQ\< 55 or\>2 school grade levels below the expected for age \[expected age = grade level +5\]).
* Clinical/Laboratory Indicators:

  * Serum creatinine \> 1.5 on the day of treatment initiation for adults.
  * Serum creatinine ≥1.5 for subjects ≥17 years old, ≥1.0 for subjects 13-17 years old and ≥0.7 for subjects 6-12 years old.
  * Pregnancy
  * Use of any CNS-active investigational drugs within 3 months of enrollment.
  * Use of Antiepileptic Drugs (AEDs) within two months of enrollment, for any indication.
  * Allergy/sensitivity to study drugs or their formulations:
  * Active drug or alcohol dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements:
  * Inability or unwillingness of subject or legal guardian/representative to give written informed consent.
Efficacy of a Single Dose of Aspirin vs. Acetaminophen in Tension Type Headache

The purpose of this trial is to determine if a single, oral dose of a fast release aspirin 1000 mg provides relief compared to acetaminophen 1000 mg and placebo in subjects with tension-type headache pain.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, ambulatory, male and female volunteers ages 18-65 years old
* History of an onset of tension type headaches before age 50
* Experiencing over the last year ≥ 4 tension type headaches of at least moderate intensity per month and with the majority of headaches lasting greater than three hours, that meet commonly recognized criteria for diagnosis per the International Headache Society
* History of response to treatment with over-the-counter (OTC) analgesics
* Understand the pain rating scales (as judged by the trial coordinator)
* Present with at least moderate headache pain on a 0-10 point numerical rating scale (a score of at least 4 on an 11 point scale ranging from 0 to 10) at the Treatment Visit
* Onset of pain within three hours of the Treatment Visit
* Confirmation by a physician of acute tension type headache symptoms as described by the International Headache Society diagnostic criteria

Exclusion Criteria:

* History of hypersensitivity to aspirin, salicylates, other NSAIDs, acetaminophen, and similar pharmacological agents or components of the investigational products, including the placebo
* Use of any immediate release analgesic/anti-pyretic within four hours or use of any sustained release or long acting analgesic/anti-pyretic within 12 hours proceeding administration of Investigational Product
* Presence of symptoms that are consistent with menstrual headache or migraine headache as described by the International Headache Society diagnostic criteria
* History of migraine headaches more than once per month
* Relevant concomitant disease such as asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than 50 percent obstruction (polyposis nasi, marked septal deviation) that can interfere with the conduct of the trial in the judgment of the Investigator
* Current or past history of bleeding disorder(s)
* History of gastrointestinal bleeding or perforation, related to previous Nonsteroidal Anti-inflammatory Drugs (NSAID) therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding)
* Recent head or neck trauma (within 2 weeks)
* Current use of blood thinning (anticoagulant), low dose aspirin, or steroid drug
The Diagnosis of Beta-lactam Hypersensitivity in Thailand

The true prevalence of drug allergy in patients with a history of beta-lactam hypersensitivity will be determined by using commercially available standard skin test reagents and the diagnostic agents available in Thailand. We hypothesize that only minority of patients with such a history are truly allergic.

Patients with a history of beta-lactam hypersensitivity will be evaluated by the standard skin test reagents (major and minor determinants of penicillin, amoxicillin, and clavulanic if applicable), and intravenous forms of beta-lactam antibiotics .

Diagnostic values of the measurement of specific Immunoglobulin E to penicillin/aminopenicillin and skin test reagents currently available in Thailand will be comparatively analyzed with the standard skin test reagents.

The measurement of drug-induced interferon-gamma releasing cells will be measured in patients with a history of non-immediate reaction.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a history of beta-lactam hypersensitivity

Exclusion Criteria:

* Being pregnant
* Having serious medical illnesses
Study of Program Interest "Bouge" to Improve the Daily Physical Activity in Processings Treatment of Non-metastatic Breast Cancer

Evaluate the "Bouge" digital program (smartphone application) to increase the daily physical activity of breast cancer patients

Controlled, randomized, open, prospective, multicentric study, 214 volunteer patients aged between 18 and 70, with breast cancer, at the start of TAXOL treatment, possessing a smartphone, will be recruited and randomized into two groups:

107 in the control group (smartphone application "placebo" = number of steps) 107 will be equipped with the application "Bouge" = coached group

For three months, the patients do their daily physical activity. The "coached" group, through the smartphone application "Bouge", receives computer coaching to increase their physical activity (no direct medical intervention, only notifications and computer pusch).

The control group is not coached by the application (simple display of the number of step)

Eligibility Criteria:
Inclusion Criteria:

non-metastatic breast cancer start of treatment with TAXOL compatible smartphone

Exclusion Criteria:

age metastatic breast cancer
Meta-Analysis of Cell-based CaRdiac stUdiEs: ACCRUE

Numerous human cardiac stem cell studies have been published, including relatively small number of patients. Meta-analysis of randomized trials have reported safety and a 3-6% increase in global left ventricular performance after intracoronary stem cell therapy in patients with acute myocardial infarction. Since most of the studies used different type of stem cells, delivery modes, and patient population, the results are heterogenous, therefore the comparison of the results is biased regarding generalizable conclusions about the effect of treatment. The present comparative meta-analysis is based on individual patient data, and gathers and pools the raw data, and analyzes the clinical outcome, safety and efficacy of the cardiac stem cell therapy.

* Background: Many clinical trials and meta-analyses presented moderate but significant improvement of the left ventricular ejection fraction (LVEF) after intracoronary autologous bone-marrow (BM) or peripheral blood origin stem cells transfer. However, it remains controversial, whether this beneficial effects is comparable with the intramyocardial delivery of the stem cells, or could be maintained during moderate and long term follow-up. The BOOST trial suggested that cardiac stem cell therapy did not improve LVEF at 5-year follow-up. By contrast, BALANCE study showed a long sustained benefit of BM-stem cells treatment. Due to these divergent outcomes of the presented trials, the aim of the present meta-analysis is to compare the safety and effectiveness of the cardiac stem cell therapy in different patient population, delivery mode and cell type, to find out, which patients with which therapy mode can have the greatest benefit from cardiac stem cell therapy.
* Study design: individual patient data meta-analysis
* Data sources: European Centre performing human cardiac stem cell therapy have been contacted calling for participation.
* Methods: Individual data gathering and entering into the database for a pooled analysis. The meta-analysis will be done in line with recommendation from the Cochrane Collaboration and the Quality of Reporting of Meta-analyses guidelines with Review Manager 5.0. Fixed-effect model will be used.

Eligibility Criteria:
Inclusion Criteria:

* patient included in one of the registered cell-based cardiac therapy of the participating center

Exclusion Criteria:

* none
Intraoperative "p50" Measurement in Liver Transplant Surgeries

The aim of this study is to compare the p50 value in routine blood gas measurements taken during liver transplant surgery follow-up with other follow-up parameters and clinical findings on the monitors, and to investigate whether there is a predictive parameter that can predict the rapidly changing clinical findings of the patients.

Blood gas monitoring is the most commonly method used by anesthetists during liver transplant surgeries. We evaluated the blood gas p50 value according to the stages in these heart transplant operations. We tried to find out how the blood gas p50 value would guide the patient's clinical findings in the dissection phase, anhepatic phase and neohepatic phase. For this purpose, we compared arterial and venous blood gas p50 values with the patient's vital signs at certain stages in liver transplant surgeries.

Eligibility Criteria:
Inclusion Criteria:

* Liver transplant recipients who will undergo Elective Liver Transplant surgery at İnönü University Faculty of Medicine Liver Transplant Institute, ASA (American Society of Anesthesiology) score III-IV, patients between the ages of 18-65

Exclusion Criteria:

* Patients with fulminant liver failure,
* hepatic encephalopathy,
* hepatorenal,
* hepatopulmonary syndrome,
* uncontrolled diabetes mellitus,
* cardiovascular, pulmonary disease,
* sepsis
* and patients who refuse consent in the informed consent form will be excluded from the study.
Post-Vent, the Sequelae: Personalized Prognostic Modeling for Consequences of Neonatal Intermittent Hypoxemia in Preterm Infants at Pre-School Age

Despite improved survival of extremely premature infants in recent decades, neonatal intensive care unit (NICU) graduates are diagnosed with asthma, sleep disordered breathing (SDB) in childhood, and neurodevelopmental impairments (NDI) at significant rates, disproportionate to their term peers. Early detection and intervention are critical to mitigate the impact of these impairments. Mechanisms leading from premature birth to these undesirable outcomes remain unclear, and accurate prognostic measures are lacking.

This study wants to learn if these problems are related to certain patterns of breathing that babies had while they were in the NICU.

Asthma, SDB, and NDI are common consequences of preterm birth with significant impact on child and family quality of life and public health. To date, the mechanisms leading to these outcomes remain unclear, and improvements in neonatal care have not improved these outcomes. While early detection and intervention can reduce the burden of these outcomes, methods for early identification of infants destined for these morbidities is currently lacking. Utilizing the Pre-Vent cohort to investigate potential underlying causes and identify predictors for these conditions as we propose here is essential to inform future prevention and intervention strategies that promote optimal health and development.

Recent compelling data indicate that early postnatal intermittent hypoxemia (IH) events may play a role in undesirable outcomes. Early postnatal IH events in extremely preterm infants are associated with bronchopulmonary dysplasia (BPD), asthma medication at 2 years, and NDI at 18 months. The ability of IH to perturb maturation of long-term respiratory control has been demonstrated in neonatal rodents consistent with preterm infants being at heightened risk for childhood SDB. Although evidence is emerging that IH events are linked to poor outcomes in premature infants, the specific relationship between distinct IH patterns (e.g. duration, timing, frequency, and nadir) and longer-term respiratory and neurologic function remains to be elucidated.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in any Institutional Review Board (IRB) protocol of the Pre-Vent Study that had signed consent, or in any IRB protocol of the Pre-Vent Study that authorized re-contact for future research
* Born \<29 weeks gestational age
* Age at enrollment less than 7 years old

Exclusion Criteria:

* Subject was withdrawn from the Pre-Vent study after signing Pre-Vent consent form, for any reason
* Subject had no physiological data recorded as part of Pre-Vent
* Lack of regulatory approval from local IRB or Department of Children and Family Services (DCFS) to recontact subjects
* Adopted by non-consenting family
* Parent refused further contact, prior to approach for Post-Vent
* Infant enrolled in Pre-Vent at Washington University St Louis, which is not a Post-Vent participating site.