cyrilzakka/clinical-trials huggingface dataset:
The Q in the Quality Adjusted Life Years (QALY): Exploring New Methods

Aim: The aim of this proposal is to investigate the potential use and value of experienced utility, as measured by the Experience Sampling Method and the Day Reconstruction Method, in the economic evaluation of health care.

Methods: Three samples of 46 patients with different conditions one sample of 46 healthy controls will be included in the study. The Experience Sampling Method (ESM) and the Day Reconstruction Method (DRM) will be adapted and subsequently used to measure experienced utility. Decision utilities will be elicited by traditional preference based methods.

Expected results: The expected results of this study are threefold. First, unified versions of the ESM and DRM for use in the economic evaluation of health care will be developed and applied. Second, a rich dataset will allow us to investigate the differences between the results of experienced utilities derived from these methods, with the traditional preference based measures. Third, the normative implications of the use of QALYs based on either decision utilities, experienced utilities, or a combination of the two, for health care resource allocation decisions, will be examined.

Keywords: experienced utility, decision utility, subjective well-being, experience sampling method, day reconstruction method

This study explores new methodology regarding the measurement of health state utilities. A new pharmaceutical is nowadays only reimbursed if there is evidence of cost-effectiveness. This can be determined by different types of economic evaluations, of which cost-utility analysis (CUA) is preferred in most guidelines. In CUA the health outcome of a technology is measured in quality adjusted life years (QALY). Utilities to calculate QALYs should be based on decisions under uncertainty (decision utilities). However, the health care literature describes several problems that lead to bias in the measurement of decision utilities. These biases lead to an inaccurate estimation of the value of a health state and can therefore cause policy makers to allocate resources inefficiently. To solve some of these problems, it was suggested to determine experiences associated with different health states by measuring well-being moment-to-moment (experienced utility) by the Experience Sampling Method or the Day Reconstruction Method.

Differences between the utilities measured using traditional preference based measures (decision utility), and using the new state-of-art methods ESM and DRM (experienced utility) in a range of populations with differing conditions and severity of health state will be investigated. Since somatic, psychosomatic and psychological conditions are likely to differ in the way they experience and affect well-being, we will involve patient groups from each category in this study as well as healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Diagnose on one of the diseases under investigation
* 18 years or older

Exclusion Criteria:

* not being able to read in Dutch
* not able to handle the ESM device because of impaired motor skills
Hypothermia and Circulatory Arrest During Surgery on the Ascending Aorta: A Comparison Between Two Cooling Methods

PURPOSE: To compare crash cooling versus gradient cooling methods for patients undergoing planned surgery on the ascending aorta in deep hypothermic circulatory arrest. To investigate the impact of hypothermia and circulatory arrest on the coagulation, stress-response, and cerebral outcome.

BACKGROUND: Cooling to 18 °C using extracorporeal circulation allows for circulatory arrest during surgery on the ascending aorta. Two different methods are used either lowering the temperature of the blood by 10 °C at a time, gradient cooling, or as cold as possible, crash cooling. The distribution of hypothermia is expected to be different for the two methods, the latter predominantly cooling the body core. The influence on the physiological response is expected to vary with the two methods. The surgical procedure and the cooling greatly elicit a stress response and the coagulation is profoundly influenced. There can be adverse effects on the neurological outcome due to the procedure. The two methods are considered equal, but have never been subjected to comparison. The surgery and circulatory changes can have a negative influence on the cerebral outcome .

METHODS: Twenty patients between 18 and 80 yrs randomized either to crash cooling or gradient cooling, ten patients in each group.. Patients with severe comorbidities or known coagulopathy are excluded. Anesthesia and operation as performed routinely in the department. The primary endpoint is duration of cooling, secondary endpoints include coagulation parameters (thromboelastography, clot stability), stress response parameters (adhesion molecule expression on endothelial cells, oxidative stress analysis, inflammatory markers), neuropsychological tests, MRI of the cerebrum, markers of cerebral ischemia, and ultrasound imaging of the great vessels for detection of air bubbles. Baseline values are obtained for all parameters.


Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for surgery on the ascending aorta
* Need for deep hypothermic circulatory arrest during the procedure

Exclusion Criteria:

* Known coagulopathy
* Ejection fraction less than 30 %
* Severe psychiatric or neurological disease
* Severe liver disease
* Severely reduced lung function
* Glomerular filtration rate less than 15 ml/min/1.73 m2
Non Invasive Neurostimulation Technology for the Treatment of Type I Complex Regional Pain Syndrome (CRPS I)

Complex Regional Pain Syndrome (CRPS) / Complex Regional Pain Syndrome (CRPS) is a chronic neurological disorder that affects the extremities and is characterized by disabling pain, swelling, vasomotor instability, sudomotor abnormality, and impaired motor function; the duration and clinical magnitude is greater than expected, being divided into three stages of progression over time: Stage I: acute (0-3 months); Stage II: dystrophic (3-9 months); Stage 3: atrophic (9-18 months).

The purpose of this study is to investigate the effect on complex pain syndrome using a conventional care protocol plus the application of non-invasive neuromodulation during compared to the effect of the same protocol plus placebo.

The design of this study is a randomised, triple blind clinical trial with placebo control.

The size of the sample will be 42 participants who come to referral hospitals. They will be randomized in two groups: control or experimental.

The variables of the study will be collected at three time points: before the intervention, during the intervention and at the end of the intervention.

The variables of the study will be collected at two time points: before the intervention and at the end of the intervention.

The statistical analysis will be an intention-to-treat analysis. For the main outcomes variables a two factor ANOVA will-be performed (intervention-time) with a post-hoc analysis with kruskal wallis correction correction. Statistical significance will be defined as p \<0.05

Eligibility Criteria:
Inclusion Criteria:

* Meet the Budapest criteria for the clinical diagnosis of CRPS type I.
* Age between 18 and 65.
* Period between 0 and 6 months after the onset of the clinical picture.
* Have signed the informed consent of their own free will.

Exclusion Criteria:

* Have a diagnosis of CRPS type II.
* Present type I CRPS in more than one limb.
* Patients who have suffered a recurrence of CRPS type I.
* Pregnancy or plans for it during the study.
* Previous sympathectomy in the affected limb.
Acne and Mood: Impact of Treatment on Depression, Anxiety, and Sexual Function

This study seeks to examine if there is any relationship between spironolactone use prescribed for acne vulgaris and depression, anxiety, and/or sexual function.


Eligibility Criteria:
Inclusion Criteria:

Female subjects between 18 and 65 years of age currently taking spironolactone for a diagnosis of acne vulgaris

OR

Female subjects between 18 and 65 years of age currently taking oral antibiotics for a diagnosis of acne vulgaris

AND Subjects able to complete an online survey in English

Exclusion Criteria:

Subjects less than 18 years of age or older than 65 years of age Subjects that have ever been diagnosed with any mood disorder by a clinician prior to starting spironolactone (history of mood disorder or current mood disorder) Subjects taking hormonal contraception (including but not limited to oral contraceptive pills) for a duration of less than 6 months Subjects that have ever been diagnosed with any type of sexual dysfunction prior to starting spironolactone Subjects not able to complete an online survey in English Subjects taking oral isotretinoin for a diagnosis of acne Subjects that are currently pregnant
Short Term Choline and Cardiovascular Health

Trimethylamine-N-oxide (TMAO), a metabolite produced by gut microbial metabolism of dietary choline, has recently been causally linked to atherosclerosis in animal models and has been shown to be predictive of cardiovascular disease (CVD) risk in some but not all cohort studies. The relevance of observations in animals to humans is unclear and little information is available on the mechanisms linking TMAO to increased CVD risk. Vascular dysfunction plays a critical role in the initiation and progression of atherothrombotic disease. Whether TMAO impairs vascular function in humans is not known. The purpose of this study is to determine if short term supplementation of dietary choline, which increase TMAO, impairs vascular function.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old, healthy, non-smoking weight stable for previous 6 months (±2.0 kg), BMI\<35 kg/m\^2, verbal and written informed consent, approved for participation by study medical director (Jose Rivero, M.D.)

Exclusion Criteria:

* Smoking, pregnancy, obese (BMI\>35 kg/m\^2), altered dietary patterns within the last month of recruitment, vegetarians, vegans, unstable heart disease or diabetes, untreated high blood pressure or high cholesterol, allergies to choline supplement, taking any medications that could affect the results (ex., aspirin, antibiotics, pre/probiotics 1 month prior to enrollment), those with trimethylaminuria
A Study Of Cisplatin (Or Carboplatin) And Etoposide With Or Without Figitumumab (CP-751,871) In Patients With Extensive-Stage Small Cell Lung Cancer

This study will summarize the safety of patients receiving figitumumab combined with etoposide and cisplatin (or carboplatin) vs. patients receiving etoposide and cisplatin (or carboplatin) alone as first line treatment for extensive stage disease Small Cell Lung Cancer.

The study prematurely discontinued on January 26, 2011 due to slow enrollment. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of extensive stage disease Small Cell Lung Cancer (SCLC), with tumor biopsy sample required.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. Total IGF-1 \> or = 120 ng/ml

Exclusion Criteria:

* Any prior systemic therapy for Small Cell Lung Cancer (SCLC)
* HbA1c \> or = 5.7%
Validity of the French Version of the Quality of Life Questionnaire COMQ12-FR

The World Health Organization estimates that chronic otitis media could reach between 65 and 350 million people worldwide and thus be an important cause of medical consultation and prescription drugs.

The medical care of chronic otitis is difficult, despite several medical and surgical treatment options. Moreover this pathology is gladly recurrent.

The completion of a standardized questionnaire to track symptoms objectively over time is fundamental to verify the efficacy of specific treatments and to compare treatments.

The quality of life measurement questionnaire related to chronic otitis media (COMQ-12) is a new questionnaire, validated in English, to assist the physician in evaluating chronic otitis media.

The objective of this study is to translate and validate the test in French in children.

The World Health Organization estimates that chronic otitis media could reach between 65 and 350 million people worldwide and thus be an important cause of medical consultation and prescription drugs.

The medical care of chronic otitis is difficult, despite several medical and surgical treatment options. Moreover this pathology is often recurrent.

The completion of a standardized questionnaire to track symptoms objectively over time is fundamental to verify the efficacy of specific treatments and to compare treatments.

The quality of life measurement questionnaire related to chronic otitis media (COMQ-12) is a new questionnaire, validated in English, to assist the physician in evaluating chronic otitis media.

The original version of the COMQ12 questionnaire, in English, was developed by Phillips et al.. The construction of this questionnaire was based on three other questionnaires : the Chronic Ear Survey (CES), the Chronic Otitis Media Outcome-15 (COMOT-15), and the Chronic Otitis Media-5 (COM-5). The initial validation of the English version of Phillips et al. was evaluated with an alpha value of Cronbach to 0.889, which shows high internal consistency and would allow its use in several reputed international centers of otology.

The objective of this study is to translate and validate the test in French in children.

Eligibility Criteria:
Inclusion Criteria:

* Minors aged 7 to 15 years (inclusive)
* Patients with chronic otitis media, united or bilateral
* Controls: subjects without chronic otitis media or any other pathology of the ear at the time of Inclusion or in background
* holders of parental authority not opposed to participation in the study

Exclusion Criteria:

- Non-comprehension of french
Mesh Fixation inTEP Inguinal Hernia Repair

Mesh fixation is used to prevent recurrence in TEP to the potential cost of pain. The aim was to evaluate the impact of permanent fixation (PF) versus non-permanent fixation (N-PF) of mesh in TEP repair for a primary inguinal hernia regarding chronic pain. A cohort of patients were studied for pain interfering with sexual activety. The hyopthesis is that fixation causes pain.

Mesh fixation is used to prevent recurrence in TEP to the potential cost of pain. The aim was to evaluate the impact of permanent fixation (PF) versus non-permanent fixation (N-PF) of mesh in TEP repair for a primary inguinal hernia regarding chronic pain.

Men between 30 and 75 years, consecutively registered in Swedish Hernia Register (SHR) for a TEP repair between 2005 and 2009 were included. A questionnaire was sent in 2010 including a general questionnaire, SF-36 and Inguinal Pain Questionnaire (IPQ). Primary endpoint was question two in IPQ, "worst pain you felt in the operated groin during this past week". Pain was defined as "pain present that could not be ignored". In adition a specific questionnair developed by the research group on pain and problems during sexual activiety were sent to patients between 30-60 years of age.

The register was checked for long term recurrent operations.

Eligibility Criteria:
Inclusion Criteria:

* Male between 30-75 years.
* Primary inguinal hernia

Exclusion Criteria:

* Emergency operation
* Operated for recurrence
* Deaths
A Randomized Controlled Trial of Routine Shave Margins Versus Standard Partial Mastectomy in Breast Cancer Patients

This research study is designed to look at whether the routine use of shave margins (by taking extra tissue at the time of partial mastectomy surgery) will reduce the chances of having positive surgical margins requiring another surgical procedure, and whether this affects the long-term chances of getting cancer back in your breast.


Eligibility Criteria:
Inclusion Criteria:

1. Breast cancer, stage 0-3, deemed a surgically appropriate candidate for partial mastectomy with planned procedure for the same.
2. Women ≥ 18 years of age.
3. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patients who have received previous neoadjuvant chemotherapy
2. Patients who require a total mastectomy
3. Known metastatic breast cancer.
Quality of Recovery Awake Versus Asleep Craniotomy

Awake craniotomy (AC) is an anesthetic and surgical technique commonly used to resect tumors involving or adjacent to the eloquent or motor cortices, those portions of the brain that are responsible for language and motor skills, respectively. By mapping those areas of the brain that are necessary for such functions, the neurosurgeon is able to avoid resection of cortical tissue that might compromise the patient's abilities to speak or move, hence preserving neurologic function. AC is often accomplished by direct cortical stimulation or inhibition, while maintaining the patient's ability to interact with the operative team. The anesthetic technique often involves a regional (scalp) block combined with intraoperative intravenous mild sedation. In some reported instances of AC, no cortical mapping is performed, and the technique is performed solely because it is thought that AC leads to a better recovery profile (less pain, better neurologic outcome, and shorter hospital stay) than craniotomy performed under general anesthesia.

The Quality of Recovery Score (QoR-40) is a validated, multi-parameter instrument that has been used in various postoperative populations to assess the overall satisfaction and well-being of patients having undergone anesthesia and surgery. Leslie et al. have reported that the QoR-40 is a valid tool in assessing neurosurgical patients, but a direct comparison between AC patients and general anesthesia craniotomy (GAC) patients using this tool has never been performed.

AC may also be associated with better 30 and 90 day multi-parameter outcomes than GAC. The well-validated Acute Short Form (SF-12) health survey, an abbreviated version of the SF-36, consists of 12 items. It measures two domains, including mental and physical component summaries (mental component summary and physical composite score, respectively).

Hypothesis:

Awake craniotomy for tumor resection is associated with a better multi-parameter quality of recovery in the immediate postoperative period, and better 30 and 90 day quality of life outcomes, than craniotomy performed under general anesthesia.


Eligibility Criteria:
Inclusion Criteria:

* Adult non-pregnant patients (age ≥ 18 years) undergoing AC or GAC for elective supratentorial tumor resection.

Exclusion Criteria:

* Patients under 18 years of age, non-English speaking, pregnancy, unable to obtain written informed consent, infratentorial tumors.
Trip HF Study: Triple Resynchronization in Paced Heeart Failure Patients

The purpose of this study is to evaluate the feasibility of permanent biventricular pacing using three ventricular leads, and its efficacy in terms of inter and intra-ventricular resynchronization, in patients with congestive heart failure and a non-functional atrium (chronic AF).


Eligibility Criteria:
Inclusion Criteria:

• NYHA class III-IV congestive heart failure, in spite of optimal medical treatment for their congestive heart failure for 1 month.

The medical treatment must include a 40 mg/day minimum dose of furosemide (or equivalent);

* Permanent atrial fibrillation (AF);
* Left ventricular ejection fraction (LVEF) ≤ 35%;
* Indication for a pacemaker implantation for a permanent and symptomatic bradycardia, or already implanted pacemaker under the condition that leads positioning corresponds to the criteria described in the protocol;
* Aortic pre-ejection delay at least equal to 140 ms.

Exclusion Criteria:

* Indication for a cardiac defibrillator;
* Having presented a myocardial infarct within the previous 3 months;
* Having undergone cardiac surgery or coronary revascularization procedure within the previous 3 months, or being scheduled for such procedures;
* Presenting chronic pulmonary insufficiency;
* Patients whose congestive heart failure requires the use of an intravenous inotropic support;
* Presenting a dysthyreosis;
* Having a life expectancy of less than one year, for other reasons than the congestive heart failure;
* Unable to be followed-up in the scope of the study for geographical reasons;
* Having refused to give their consent;
* Minors (age \< 18 years) and pregnant women.
Anti-CD19 U-CAR-T Cell Therapy for B Cell Hematologic Malignancies

The stunning response rate of anti-CD19(cluster of differentiation antigen 19) auto-CAR(chimeric antigen receptor)-T cell therapy brings hope to patients with relapsed or refractory B-cell hematologic malignancies. However, based on open clinical trials, using patients' T cells might encounter the failure of apheresis available T cells, even if successful, the time needed for the manufacture could also cause the irreversible disease progress. Furthermore, the cost of auto-CAR-T cells is not affordable for most patients. So to provide an accessible and affordable anti-CD19 CAR-T cell therapy for patients with B-cell hematologic malignancies, we launch such a trial that using the edited T cells from healthy donors to manufacture universal CAR-T cells and adapt it in patients with CD19+ B-cell leukemia or lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* 1. Diagnosis of recurrent B-cell acute lymphoblastic leukemia (B-ALL), B-cell acute lymphoblastic lymphoma (B-LLy), or B-non-Hodgkin lymphoma (B-NHL)

  2. CD19-positive tumor (≥20% CD19 positive blasts by flow cytometry or immunohistochemistry (tissue)）

  3. Hgb ≥ 7.0 (can be transfused)

  4. Life expectancy greater than 12 weeks

  5. Informed consent explained to, understood by and signed by the patient/guardian. The patient/guardian is given a copy of informed consent.

Exclusion Criteria:

1. Pregnant or lactating.
2. Tumor in a location where enlargement could cause airway obstruction (per investigator discretion).
3. Active infection with HIV or HTLV.
4. Clinically significant viral infection or uncontrolled viral reactivation of EBV(Epstein-Barr virus), CMV(cytomegalovirus), ADV(adenovirus), BK-virus, or HHV(human herpesvirus)-6.
5. Any of the following cardiac criteria: Atrial fibrillation/flutter; Myocardial infarction within the last 12 months; Prolonged QT syndrome or secondary prolonged QT, per investigator discretion. Cardiac echocardiography with LVSF (left ventricular shortening fraction)\<30% or LVEF(left ventricular ejection fraction)\<50%; or clinically significant pericardial effusion. Cardiac dysfunction NYHA(New York Heart Association) III or IV (Confirmation of absence of these conditions on echocardiogram within 12 months of treatment).
6. CNS abnormalities: Presence of CNS(central nervous system)-3 disease defined as detectable cerebrospinal blast cells in a sample of CSF(cerebrospinal fluid) with ≥ 5 WBC( white blood cell)s per mm3 (unless negative by the Steinherz/Bleyer algorithm); Presence of any CNS disorder such as an uncontrolled seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.