cyrilzakka/clinical-trials huggingface dataset:
National Acute Promyelocytic Leukemia (APL) Observational Study NAPOLEON-Registry of the German AML Intergroup

The registry aims to document epidemiologic data, treatment and long-term outcome as well as quality of life of patients with APL. Additionally, a biobanking project for further translational studies is integrated.

Prospective population-based non-interventional and non-randomized multicenter registry.

* collection of epidemiological data for APL: age distribution, prognostic factors, distribution of subgroups, incidence
* documentation of efficacy and safety of the first line and salvage therapy in APL including
* documentation of minimal residual disease (MRD)
* correlation of clinical outcomes with chosen therapy
* collection and evaluation of quality of life
* validation of published prognostic factors / new potential prognostic factors
* acquisition of bone marrow, peripheral blood and buccal swab samples for biobanking and translational studies under the umbrella of the specific study-group biobanking concepts

Eligibility Criteria:
Inclusion Criteria:

* newly-diagnosed APL (either de novo or therapy-related), within 12 months of diagnosis
* or relapsed APL, within 12 months of diagnosis of relapse

  1. confirmed by the presence of the translocation t(15; 17)
  2. and / or confirmed by the detection of the fusion transcript of PML/RARa

Exclusion Criteria:

* none
A Study to Evaluate the Safety of Electronic Vapor Products for 2 Years

Electronic Vapour Products (EVPs) is a relatively new class of consumer products that are otherwise known as electronic cigarettes devices/systems. These may look like conventional cigarettes but do not contain tobacco.

The 'vapour' produced by such devices typically consists of humectants (propylene glycol or glycerol), nicotine, water, and flavours.

This trial is to evaluate the safety and tolerability of an EVP over two years.


Eligibility Criteria:
Inclusion Criteria:

* Subject who participated in the EVP G1 S2 study (S2)
* Willingness to use the EVP provided by the sponsor for two years as the only nicotine containing product
* No clinically significant abnormalities during the S2 study

Exclusion Criteria:

* Subjects who have used nicotine replacement therapy during the S2 study
* Subjects with relevant illness history
* Subjects with history of drug or alcohol abuse
* Subjects with lung function test or vital signs considered unsuitable Subjects who are trying to stop smoking
* Female subjects who are pregnant, or unwilling to use acceptable contraceptive method for the duration of the study.
Post-marketing Surveillance to Assess the Safety of Boostrix Vaccine Given According to Prescribing Information in Korea

The purpose of this study is to collect safety information from pre-adolescents, adolescents and adults after Boostrix vaccination is administered according to the approved prescribing information in Korea.

Protocol amendment 3 rationale was as follows:

* Age for analysis set is specified.
* Subjects with pregnancy will be analyzed by their pregnancy status before/after vaccination.
* Pregnancy notifications must be done within 2 weeks

Eligibility Criteria:
Inclusion Criteria:

* Written or signed informed consent obtained from the subject/ subject's parent(s)/Legally Acceptable Representative(s) of the child. Korean male or female subjects who were recently vaccinated or eligible to receive Boostrix according to the locally approved Prescribing Information.

Exclusion Criteria:

* Those who are not eligible for vaccination according to the local Prescribing Information.
* Child in care.
Feasibility of the Integrative Medication Self-Management Intervention to Promote Medication Adherence

Many persons with chronic health conditions fail to take their medications as prescribed, resulting in declines in health and function. Unfortunately, current interventions for medication nonadherence are not very effective. This objective of this study is to test a new intervention, the Integrative Medication Self-management (IMedS) intervention to improve medication adherence in adults with chronic health conditions.

Many persons with chronic health conditions fail to take their medications as prescribed, resulting in declines in health and function. Objective: The purpose of this study was to perform a phase I feasibility study to understand if an integrated occupational therapy intervention could help people with chronic health conditions improve their adherence to medications. Method: Using a small-N design, we report single-subject analyses of the medication adherence, behavior counts, and perceptions of medication adherence of participants before and after either an occupational therapy intervention or standard of care intervention. We used a multiple baseline approach with inter-subject replication, and blinding.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with a chronic health condition
* Live in the community
* A medication regimen of 5 or more medications a day recommended by a health care professional
* Independently manage medications
* Difficulty taking medications as prescribed
* Live in the Milwaukee area

Exclusion Criteria:

* Significant cognitive impairment
A Prospective Longitudinal Study of Health-Related Quality of Life in Men With Clinically Localized Prostate Cancer

to prospectively assess the health-related quality of life (HRQOL) changes during the first year after different treatment modalities for localized prostate cancer.

Quality of life is of great concern to patients considering treatment options for prostate cancer. Patients with clinically localized prostate cancer treated with active surveillance, radical prostatectomy, external radiotherapy and high intensity focused ultrasound were included. All men completed the questionnaires of Functional Assessment of Cancer Therapy-Prostate (FACT-P) (version 4), International Prostate Symptom Score (IPSS) and International Index of Erectile Function (IIEF) before treatment and 1, 3, 6, 12 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with clinically localized prostate cancer

Exclusion Criteria:

* patients with another malignancies
Health of Young European Families and Fish Consumption

This is a controlled, randomized, intervention trial (CRIT) with 20-40 year old overweight individuals (n = 320) across Europe in order to distinguish between biologically active components of seafood, i.e., seafood proteins and n-3 lipids, regarding their effects on risk factors for metabolic syndrome, bone health, and weight management.

Subjects were recruited through advertisements from October 2004 until April 2005. Recruitment of 320 subjects (140 from Iceland, 120 from Spain, and 60 from Ireland). The inclusion criteria were body mass index (BMI) 27.5 to 32.5 kg/m2, age 20-40 years, and a waist circumference of equal or more than 94 cm and 80 cm for men and women, respectively. Exclusion criteria were weight change due to weight loss diet within 3 months before the start of the study, use of supplements giving n-3 fatty acids, calcium or vitamin-D during the last three months, drug treatment of diabetes mellitus, hypertension or hyperlipidemia and women's pregnancy or lactation. Each subject was instructed to follow a diet, energy-restricted by 30% from estimated energy expenditure (approximately 600 kcal/day), for 8 consecutive weeks. The subjects were randomly assigned to four diets varying in types of dietary protein and amount of n-3 fatty acids (especially very long chain n-3 fatty acids):

I: no seafood (control, including 6 placebo capsules/day)

II: lean fish (150 g cod x 3/week)

III: fatty fish (150 g salmon x 3/week)

IV: fish-oil capsules (6 capsules/day)

Risk factors for metabolic syndrome, bone health and weight management were analysed at baseline and endpoint.

Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) of 27.5 to 32.5 kg/m2
* Ages 20-40 years
* Waist circumference of equal or more than 94 cm and 80 cm for men and women, respectively

Exclusion Criteria:

* Weight change due to weight loss diet within 3 months before the start of the study
* Use of supplements giving n-3 fatty acids
* Calcium or vitamin D during the last three months
* Drug treatment for diabetes mellitus
* Hypertension or hyperlipidemia
* Women's pregnancy or lactation
Case Management Alternatives for African American Women at High Risk for HIV

The purpose of this study is to test two innovative case management approaches designed to increase linkages and engagement with drug abuse treatment, HIV-related care, and other health services among an underserved population of African American women at risk for HIV.

The study is fundamentally concerned with the implementation and evaluation of theoretically-based, culturally appropriate case management interventions targeting individual, social and environmental factors among highly vulnerable African American women. The research is designed to test innovative, comprehensive approaches to HIV prevention/intervention through case management driven service linkage and engagement. Testing new approaches to intervention with African-American women at high risk for HIV addresses a particularly urgent public health need in Miami, as well as other large metropolitan areas, where officials continue to document epidemic rates of HIV/AIDS clustered in urban, impoverished African-American communities.

Comparison: Participants will be randomly assigned to: a Strengths-Based / Professional Only Condition in which clients participate in a "strengths-based" case management approach; or, a Strengths-Based / Professional/Peer Condition in which a team composed of: a) a credentialed, professional case manager and b) a recovering addict peer - both trained in "strengths-based" case management techniques - develop and facilitate the implementation of a service plan.

Eligibility Criteria:
Inclusion Criteria:

* Current substance abuse
* Current high-risk sexual behavior
* African American racial identification

Exclusion Criteria:

* Non resident of Miami-Dade county
Comorbidities and Indirect Health State Utility in Hip and Knee Osteoarthritis

National cohort study aimed to investigate the impact of comorbidities (number and type of comorbidities) on health utility state change in lower lim osteoarthritis (hip and knee OA).

The concept of health utility state was developed by economists to explain individual choices and preferences for health states. It is expressed as the "desirability or preference that individuals exhibit for the condition". This health utility state can be measured indirectly using health-relation quality of life questionnaires.

Chronic diseases such as OA are known to be associated with impairment of quality of life. Given that OA prevalence increases with age, OA is often associated with other diseases (comorbidities). A cross-sectional study showed that comorbidities are associated with lower health utility state in OA. Investigation of longitudinal impact of comorbidities on health utility state change is need.

Main objective: Determine the impact of comorbidities on change in health utility state among patients with lower limb OA.

Secondary objective: Determine the Minimal Clinically important Difference in health utility state among patients with lower limb OA.

The COMUTAR study uses longitudinal data from the Knee and Hip Osteoarthritis Longitudinal Assessment (KHOALA) cohort study. Health utility state is measured indirectly using Medical Outcome Study Short Form-36 quality of life questionnaire Comorbidities are assessed using the Functional Comorbidity Index

Eligibility Criteria:
Inclusion Criteria:

* age: 40-75 years
* Uni or bilateral lower limb osteoarthritis (OA) according to the American College of Rheumatology (ACR) and European league against rheumatism (EULAR) criteria

Exclusion Criteria:

* Hip or knee prothesis
* Antecedent of osteotomy
* Severe comorbidity
* Adult under legal protection
The BIG Score and In-Hospital Trauma Mortality

This study investigated the efficacy and reliability of the BIG score, calculated based on the base deficit (BD), International Normalized Ratio (INR), and Glasgow coma scale (GCS), in comparison with the GCS, Revised trauma score (RTS), and Injury Severity Score (ISS) for predicting in-hospital mortality in adults with multiple-trauma presenting to the emergency department (ED).

This retrospective, observational, single-center study included 563 consecutive adults (≥ 18 years old) with multiple trauma who were admitted to our emergency department and hospitalized between January 2022 and December 2023. We assessed patient demographics (age and sex), vital signs on admission (systolic blood pressure \[SBP, mmHg\], heart rate \[HR, beats/min\], respiratory rate \[RR, breaths/min\], and peripheral oxygen saturation \[SpO2, %\]), complaints and symptoms on admission, anatomic region of injury, type of trauma (blunt or penetrating), mechanism of injury, BD measured in blood gases, INR, trauma scoring systems (e.g., GCS, RTS, ISS, and BIG score), and clinical outcomes (discharge, hospitalization, or death). The study cohort was divided into survivors and non-survivors. Survivors were defined as patients who were still alive after 28 days, while non-survivors had passed away within that time. The demographics, clinical characteristics, and trauma scoring systems were compared between survivors and non-survivors to determine the prognosis of patients with multiple trauma. Independent predictors of mortality were determined by multivariate logistic regression analysis of variables (demographic characteristics, clinical characteristics, and trauma scores) that differed significantly between survivors and non-survivors. Receiver operating characteristic (ROC) curve analysis was performed to establish cut-off values for the GCS, RTS, ISS, and BIG score, and then to assess the sensitivity and specificity of these scoring systems in terms of predicting in-hospital mortality.

Eligibility Criteria:
Inclusion Criteria:

* This study included 563 consecutive adults (≥ 18 years old) with multiple trauma who were admitted to our Emergency Department and hospitalized between January 2022 and December 2023.

Exclusion Criteria:

* Patients aged \< 18 years and adults who were discharged from the Emergency Department
* Patients with non-traumatic injuries and those who presented to the Emergency Department for reasons other than trauma
* Patients with missing Base Deficit and International Normalized Ratio levels
* Patients who had been admitted to the hospital more than 24 hours after the trauma
* Patients with single trauma (e.g., isolated extremity trauma, isolated head injury, etc.)
* Patients with chronic conditions such as chronic renal failure or hepatic, hematological, or neurological diseases
A Study Of BRL49653C For The Treatment Of Type 2 Diabetes (Combination Therapy With Sulfonyl Urea) -With Placebo Study

This study was designed to compare the efficacy and safety of BRL49653C versus placebo with concomitant use of sulfonyl urea (SU).


Eligibility Criteria:
Inclusion criteria:

* Patients with type 2 diabetes mellitus managed by SU will be candidate for this study. These candidates will be checked up on their clinical laboratory data, and must have adequate blood, liver and kidney function.

Exclusion criteria:

* Patient with serious cardiovascular disease or serious hepatic disease will not be eligible.
Benefits of a Bolus Calculator in Pediatric Patients on Multiple Daily Insulin Injections

It it hypothesized that children and adolescents with type 1 diabetes, who are counting carbohydrates can achieve better metabolic control by concurrent use of the Accu-Chek Aviva Expert. Additionally, it is proposed that carbohydrate counting in combination with the the Accu-Chek Aviva Expert will lead to better quality of life as a result of fewer restrictions when eating and less variation in blood glucose.

Carbohydrate (Carb) counting is a meal planning approach for patients with diabetes mellitus that focuses on carbohydrate as the primary nutrient affecting postprandial glycaemic response. In the early 1990's the Diabetes Control and Complications Trial (DCCT) used Carb counting as one of its education tools. More recently, short acting insulin analogues and insulin pumps have made the role of Carb counting important and popular. Carb counting can be used to estimate carbohydrate intake and adjust insulin around mixed meals and snacks using insulin to carbohydrate ratio. This effectively addresses the variable eating habits of most children and adolescents. Carb counting can make food planning more flexible and thus more acceptable for young patients with diabetes.

Roche has recently launched the Accu-Chek Aviva Expert recently preliminary tested in adults4, being a blood glucose meter with integrated bolus calculator and memory function. This bolus calculator estimates the dose of insulin to be administrated on the basis of the following parameters: Current blood glucose, grams of carbohydrate, carbohydrate to insulin ratio, insulin sensitivity, target blood glucose and insulin action time.

Hypothesis:

It is hypothesized that paediatric patients in MDI therapy with suboptimal regulated diabetes will achieve better glycemic control by using Accu-Chek Aviva Expert rather than carbohydrate counting alone without the use of an external calculator.

Eligibility Criteria:
Inclusion Criteria:

* - Patients with type 1 diabetes (n=120) Age \> 1 year and \< 18 years
* Diabetes duration \>12 months
* MDI therapy (fast acting analog for meals; long acting analog as basal)
* HbA1c \> 7.0% and \<11%

Exclusion Criteria:

* Insulin pump therapy
* Missing consent declaration
Use of Electropalatography to Improve Speech Sound Production

The purpose of this proposed study is to examine the benefits of using electropalatography (EPG) during speech therapy with adult individuals who are either congenitally deaf or adventitiously deaf and use a cochlear implant.

It has been established in numerous research studies that there is a definitive link between speech perception and speech production, in that what one can perceive, one can produce. Hearing loss disrupts this link and while cochlear implants make a significant difference in perception of sound, adults who are deaf and receive a cochlear implant (CI) do not gain the same perceptual benefits as children who are deaf and are implanted at a young age. Thus, the speech production of the adult CI user is reported to be less intelligible. The purpose of this proposed study is to examine the benefits of using electropalatography (EPG) during speech therapy with adult individuals who are either congenitally deaf or adventitiously deaf and use a cochlear implant. The investigators have proposed to study 10 CI users (5 in each etiological group) who will undergo speech intelligibility testing, and receive speech therapy (1x/week for 10 weeks) using EPG that provides both visual (biofeedback) and auditory feedback. It is hypothesized that the biofeedback in addition to the auditory feedback from the CI will result in an increase in articulation skills and thus the speech intelligibility in these individuals will improve significantly.

Eligibility Criteria:
Inclusion Criteria:

* All participants in this study will be at least 3 years post-implant and they must use the implants consistently.
* Participants who have adventitious/acquired hearing loss must have had normal hearing through their 18th year.
* Participants with congenital hearing loss will have received oral or total communication education, worn hearing aids and consider themselves to be "oral deaf" adults.

Exclusion Criteria:

* Individuals who do not meet this criteria will be excluded from the protocol.
Study of Household Purchasing Patterns, Eating and Recreation

This project examines behavioral and household characteristics associated with food purchasing patterns.


Eligibility Criteria:
Inclusion Criteria:

1. Adult individual who reports making at least 75% of household food purchases
2. Resides in City of Chicago, Illinois or surrounding suburbs

Exclusion Criteria:

1. Inability to provide informed consent in English
2. Living in transitional housing or on a college campus
3. Lack of a cellular or land line phone
4. Gang presence or illegal activity in the immediate vicinity of the home, or other factors jeopardizing researcher safety during home visits (e.g., extreme unsanitary conditions)
5. Having a household member, including the primary shopper, with a medical condition or food allergy that substantially influences household food choices (e.g., phenylketonuria, celiac disease)
Impact of Regional Anesthesia on Blood Pressure in Humeral Fracture Surgery

This study aims to compare the hemodynamic impact of two anaesthetic strategies : Regional anesthesia versus General anesthesia in proximal humeral fracture surgery.

Proximal humeral fracture surgery is frequently performed under General Anesthesia (GA).

GA is frequently associated with a high risk of hypotension with significant consequences.

Regional anesthesia could be an interesting alternative to GA in order to limit hemodynamic consequences, especially in elderly patients. Furthermore, in the current state of Covid 19 crisis, regional anesthesia could provide solutions in exposing less medical staff on patient's airway.

The investigators hypothesize that the use of Regional anesthesia reduces the use of intraoperative vasopressor during surgery.

After ethical committee approval, a retrospective cohort of patients with proximal humeral fracture, in Montpellier's University Hospital, was analyzed from 2016 to 2020. An informational note was given to all patients participating to the study.

Eligibility Criteria:
Inclusion Criteria:

* ASA I - IV
* Proximal humeral fracture
* Operated between january 2016 and december 2020
* Emergency surgery

Exclusion Criteria:

* Surgical revision or surgery for pre-existing infection, tumour
* Intubated patient / unconscious patient
* Haemostasis disorder
* Haemostasis disorder
* Refusal of the patient
The Evaluation of Ankle Joint Braces Efficiency

The project concerns the evaluation of commercially available ankle joint braces effectiveness used as orthopedic supply after ankle joint ligaments tear injury. Authors hypothesize that the restriction of range of motion may be not sufficient in the early healing process.


Eligibility Criteria:
Inclusion Criteria:

* age 18-35
* female or male
* good health condition
* chronic ankle joint instability (for chronic ankle instability group)

Exclusion Criteria:

* lower limb injuries (last 6 months)
* extreme sports athletes
* no chronic ankle joint instability (for chronic ankle instability group)