cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of Use of Prismocitrate 18 in Patients Undergoing Acute Continuous Renal Replacement Therapy (CRRT)

The purpose of this research is to determine if an investigational new drug solution called Prismocitrate 18 lengthens extracorporeal circuit life in patients treated with continuous renal replacement therapy (CRRT). Patients who receive CRRT treatment with Prismocitrate 18 as the anticoagulant will be compared to patients who receive CRRT treatment with no anticoagulation.


Eligibility Criteria:
Inclusion Criteria:

1. Patient must be receiving medical care in an intensive care unit (ICU) (e.g., medical ICU, surgical ICU, cardiothoracic ICU, Trauma ICU, Mixed ICU, other).
2. Adult patients with AKI or other serious conditions who require treatment with CRRT.
3. Patients are expected to remain in the ICU and on CRRT for at least 72 hours after randomization.
4. Patients already receiving standard-of-care CRRT must be randomized within 24 hours of initiation of their standard-of-care CRRT.

Exclusion Criteria:

1. Patients requiring systemic anticoagulation with antithrombotic agents for reasons other than CRRT. The exception is patients receiving subcutaneous heparin for deep vein thrombosis prophylaxis according to institutional practice or patients on aspirin may be enrolled.
2. Patients in whom citrate anticoagulation is contraindicated such as patients with a known allergy to citrate or who have experienced adverse events associated with citrate products including patients with a prior history of citrate toxicity or patients with uncorrected severe hypocalcemia (whether in the context of current citrate administration or due to the underlying disease state).
3. Patients who are not candidates for CRRT.
4. Patients who are receiving extracorporeal membrane oxygenation (ECMO) therapy.
5. Patients with severe coagulopathy \[i.e., platelets \< 30,000/mm3, international normalized ratio (INR) \> 2, partial thromboplastin time (PTT) \> 50 seconds\] including severe thrombocytopenia (platelets \< 30,000/mm3), HIT (heparin induced thrombocytopenia), ITP (idiopathic thrombocytopenia purpura), and TTP (thrombotic thrombocytopenia purpura) should not be enrolled in the trial.
6. Patients with fulminant acute liver failure or acute on chronic liver failure as documented by a Child-Pugh Liver Failure Score \> 10.
7. Patients with refractory shock associated persistent, worsening with lactic acidosis (lactate \> 4 mmol/L). However, patients with improving subsequent serum lactate levels may be enrolled.
8. Patients unlikely to survive at least 72 hours.
9. Female patients who are pregnant, lactating, or planning to become pregnant during the study period.
10. Patients who are currently participating in another interventional clinical study.
11. Patients with a medical condition that may interfere with the study objectives.
Impact of Formal Home Help on Quality of Life for Caregivers of Elderly Patients With Neurocognitive Impairment

The purpose of this prospective monocenter observational study is to assess the impact of the first introduction of formal home help (personalized autonomy allowance for seniors) on the quality of life of home caregivers of elderly patients with neurocognitive impairment.

An aging population is leading to an increase in neurodegenerative disorders that are responsible for loss of autonomy. In order to keep patients with neurocognitive impairment at home, the availability of home caregivers is essential. The neurocognitive deterioration of elderly patients is a significant burden for home caregivers and can affect their quality of life. The implementation of formal home help (personalized autonomy allowance for seniors) can relieve home caregivers and improve their quality of life.

Conduct of research:

Elderly patients followed in the geriatric department of the Mulhouse French hospital, and for whom a formal home help (personalized autonomy allowance for seniors) is initiated will be recruited. The evolution of home caregiver's quality of life, burden and vulnerability, will be assessed during three months.

Eligibility Criteria:
Inclusion criteria:

* Patient 60 years of age or older
* Diagnosis of neurocognitive disorders
* MMSE score less than or equal to 26
* GIR score inferior or equal to 4
* Introduction of formal home help (personalized autonomy allowance for seniors program)
* Patient living in Haut-Rhin department (France)
* Patient receiving regular informal help at home (at least once a week)
* Availability of the current home helper to participate in the sudy
* Non-opposition to participation in the study

Exclusion criteria:

* Introduction of formal home care not related to the personalized autonomy allowance program
* Patient under legal protection
Gender Discrimination Against Female Surgeons A Study in a Lower-Middle-Income Country

our study explores how GD is perceived and reported by surgeons in Pakistan.

Due to an increasing spotlight, gender discrimination (GD) is identified and reported in many aspects of surgical training and practice in the developed world 1, 2. In contrast, lower-middle-income countries like Pakistan lack awareness and strategies to counteract GD, which manifests as a lack of females in leadership and academic positions, and pay inequities. GD often occurs insidiously, as a result of complex interplay between societal norms, gender stereotypes and learned behaviors. Thus, our study identifies how GD is perceived and reported by surgeons in Pakistan.

Eligibility Criteria:
Inclusion Criteria:

* all consultants
* fellows
* instructors
* medical officers
* residents working in the Department of Surgery

Exclusion Criteria:

* all consultants
* fellows
* instructors
* medical officers
* residents not working in the Department of Surgery
Glycemic Optimization Treatment Study

To compare the frequency of severe hypoglycemia events for 5 dosing algorithms of Lantus®, each of varying intensity and defined by their end-of -study target for self monitored plasma glucose(SMPG), in patients with Type 2 diabetes mellitus, with inadequate glycemic control (A1C greater than or equal to 7.0%) on oral antidiabetic drug therapy(OAD).


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must give their signed informed consent.
2. Diagnosis of Type 2 DM for at least 6 months.
3. Males and females greater than or equal to 18 years of age.
4. A1c greater than or equal to 7.0%.
5. Current (last 2 months) diabetes therapy with oral anti-hyperglycemia agents only.
6. Demonstrated willingness and ability to inject insulin glargine.
7. Able to understand and willing to comply with procedures required by the protocol and have access to a phone.
8. Demonstrated ability and willingness to perform self-monitoring of blood glucose (SMBG) and use of the algorithm calculator (AL-CAL).
9. BMI greater than 25.0 kg/m2.
10. Subjects who, in the opinion of the investigator, should be initiated on insulin therapy.

Exclusion Criteria:

1. Cardiac status New York Heart Association (NYHA) III-IV (Appendix A).
2. For subjects treated with metformin (Glucophager, Glucophage XRr, Glucovancer, Metaglipr , or Avandametr) plus a serum creatinine greater than 1.5 mg/dL (133 μmol/L) for males or greater than 1.4 mg/dL (124 μmoL) for females, the inability or unwillingness to discontinue these medications, and to remain off them through the entire study.
3. For subjects on thiazolidinediones, the inability or unwillingness to discontinue these medications and to remain off them through the entire study.
4. Planned pregnancy, pregnancy, or lactation.
5. Serum creatinine greater than 3.0 mg/dL (266 μmol/L).
6. Serum glutamic pyruvic transaminase (SGPT) greater than 2.5 x the upper limit of normal range.
7. Any current malignancy or cancer within the past 5 years (except adequately treated basal cell carcinoma or cervical carcinoma in situ).
8. Diagnosis of dementia or mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
9. Hypersensitivity to Lantus® insulin or any of its components.
10. Any disease or condition, including the abuse of illicit drugs, prescription medicines, or alcohol that, in opinion of the sponsor/investigator, may interfere with the completion of the study.
11. Current (last 2 months) insulin therapy.
12. With the exception of thiazolidinediones (for all potential subjects) and for subjects who are taking metformin and have an exclusionary creatinine level, the ability or unwillingness to continue pre-study anti-hyperglycemia agents at pre-study dosages through the entire study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Brief Intervention to Reduce Drinking Among Batterers

The goal of this project is to examine whether, relative to standard care, violence and alcohol use outcomes can be improved by a brief, motivationally based adjunct alcohol treatment for men enrolled in batterer intervention programs. We hypothesize that men randomized to also receive the brief alcohol intervention will have better partner violence and alcohol use outcomes than men who are randomized to the batterer intervention program alone.


Eligibility Criteria:
Inclusion Criteria:

* Participation in a batterer intervention program
* Hazardous drinking
Pharmacokinetic and Pharmacodynamic Study of S-1 in Patients With Digestive Organ Cancer

S-1 is a novel oral fluorouracil antitumor drug that consists of tegafur which is a prodrug of 5-fluorouracil (5-FU); 5-chloro-2,4-dihydropyridine (CDHP), which inhibits dihydropyrimidine dehydrogenase (DPD) activity; and potassium oxonate (Oxo), which reduces gastrointestinal toxicity. 5-FU is metabolized by CYP2A6 and DPD. In this study, the researchers investigate the influences of differences in activities of CYP2A6 and DPD on pharmacokinetics and pharmacodynamics of S-1 and clinical outcomes in digestive organ cancer patients treated with S-1.


Eligibility Criteria:
Inclusion Criteria:

* Patients with digestive organ cancer

Exclusion Criteria:

* Patients without digestive organ cancer
Comparison Between Anterior Approach (Deltopectoral) and Lateral Approach (Deltoid Splitting) in Shoulder Reverse Arthroplasty for Proximal Humerus Fracture

The aim of the study consists in comparing two surgical approaches (deltopectoral versus lateral deltoid splitting) in the treatment of proximal humerus fractures treated with a reversed total shoulder arthroplasty The assessment will focus on clinical (clinical scores, efficacy, safety...) and radiological results, between these two types of surgical approaches by using a prospective, randomized analysis.

The 2 main surgical approaches in total shoulder arthroplasty (TSA) are the anterior approach (deltopectoral) and the lateral one (deltoid splitting) (18).

Their advantages and drawbacks have not been clearly evaluated in proximal humerus fracture treated with an arthroplasty.

The goal of the study is to compare the results between patients (older than 65yo) presenting a proximal humerus fracture treated with a reversed shoulder arthroplasty performed through an anterior approach or a lateral one.

Eligibility Criteria:
Inclusion Criteria:

* Patient older than 65yo with a proximal humerus fracture (Neer 3-4 and 2 dislcated)
* Patient registered to the national health system
* Patient able to understand information about the protocol and answer to questionnaire

Exclusion Criteria:

* Non-displaced fracture or no need of surgical treatment.
* Existing bone disease
* Infection
* Neurological deficit (axillary nerve)
* Multi-injured patients
* Patient no able to fulfill the questionnaire
* Patient refuses the study
Functional Characterization of Thrombopoietin/cMPL Receptor Mutations in Myeloproliferative Neoplasia

The MPL gene is implicated in two groups of hematological pathologies: congenital amegakaryocytic thrombocytopenia (CAMT) and Phi negative myeloproliferative neoplasia (MPN). Fifty germline mutations have been identified in CAMT, yet only a dozen activating mutations have been described in MPN. Most are somatic, distributed mainly in the transmembrane (TM) and juxtamembrane (JM) domains. However, a few rare germline mutations located in the extracellular domain (ECD) have also been reported: K39N, R102P and P106L.

Next generation sequencing technology has been used to study the complete MPL gene, identifying numerous variants, most of unknown significance. The study investigators have a series comprising 41 variants of unknown significance, whose allelic frequencies suggest a germline origin for 80% of them. Their distribution within the MPL gene is similar to that of inactivating mutations, except that they were discovered in the context of suspected myeloproliferative disease. Characterizing the activity of these variants would confirm the diagnosis of MPN, opening the door to specific treatment (cytoreductive, JAK2 inhibitor or interferon). It also has an important prognostic value, particularly in the case of MPN, for which life expectancy varies from 5 to 7 years, with terminal progression to acute myeloid leukemia (AML in 15 to 20% of cases) or bone marrow failure.

Using a battery of functional assays, this study aims to characterize these variants.


Eligibility Criteria:
Inclusion Criteria:

• Patient with suspected MPN

Exclusion Criteria:

• Patient with variant of cMPL already described in the literature.
Development of Assessment Method for Driving Ability Using Driving Simulator in Healthy Volunteers #2

The purpose of this study is to verify the intra-individual difference of the SDLP values in driving simulator.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) ≥18.5 and \<25.0 kg/m2 at screening inspection
* No visual impairment (enable to correct the vision with eyeglasses or contact lens)
* Receive a prior explanation on the study, able to accept its content, and capable to provide voluntary written consent for participation in this study

Exclusion Criteria:

* History of drug and food allergy
* Routinely drink alcohol before bedtime
* Inappropriate for enrollment in this study was judged by principal investigator or subinvestigator
Karenitecin in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer

Phase II trial to study the effectiveness of karenitecin in treating patients who have persistent or recurrent ovarian epithelial cancer or primary peritoneal cancer that has not responded to platinum-based treatment. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

OBJECTIVES:

I. Determine the antitumor activity of karenitecin in patients with persistent or recurrent platinum-resistant ovarian epithelial or primary peritoneal cancer.

II. Determine the toxicity of this drug in these patients.

OUTLINE: This is an open-label study.

Patients receive karenitecin IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed ovarian epithelial or primary peritoneal cancer

  * Recurrent or persistent disease
  * Platinum-resistant disease
* At least 1 unidimensionally measurable lesion

  * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
* At least 1 target lesion to assess response (tumors within a previously irradiated field are designated as non-target)
* Ineligible for a higher priority GOG study or other phase II cytotoxic study for platinum-resistant disease
* Performance status - GOG 0-2
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin no greater than 1.5 times upper limit of normal (ULN)
* ALT no greater than 2.5 times ULN
* Alkaline phosphatase no greater than 2.5 times ULN
* Creatinine no greater than 1.5 times ULN
* No myocardial infarction within the past 6 months
* No cerebrovascular accident within the past 6 months
* No transient ischemic attack within the past 6 months
* No uncontrolled hypertension
* No decompensated or uncontrolled chronic heart failure
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No neuropathy (sensory or motor) grade 2 or greater
* No other invasive malignancies within the past 5 years except nonmelanoma skin cancer
* No active infection requiring antibiotics
* At least 3 weeks since prior biological or immunological agents
* See Disease Characteristics
* At least 3 weeks since prior chemotherapy and recovered
* No more than 2 prior cytotoxic chemotherapy regimens, with no more than 1 non-platinum, non-taxane regimen
* No prior karenitecin or camptothecin analogue/derivative
* At least 1 week since prior hormonal therapy

  * Concurrent hormone replacement therapy allowed
* See Disease Characteristics
* At least 3 weeks since prior radiotherapy and recovered
* No prior radiotherapy to more than 25% of marrow-bearing areas
* Recovered from recent surgery
* At least 3 weeks since prior therapy directed at this malignancy
* No prior anticancer therapy that would preclude study therapy
* No concurrent amifostine or other protective reagents
Covid-19, Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) and Influenza Treatment System With Machine Learning

This is an open-tabled, one-arm observatory trial to assess the effectiveness and safety of the Autonomous Treatment System Based on Machine Learning in patients with Covid-19, Post-Acute Sequelae of SARS-CoV-2 infection and influenza.

This study has enrolled 27 patients diagnosed with Covid-19, Post-Acute Sequelae of SARS-CoV-2 infection, and influenza. Of these patients, 26 are outpatients, and 1 is hospitalized. After screening based on the inclusion and exclusion criteria, eligible patients will receive prescriptions recommended by the Autonomous Treatment System Based on Machine Learning in this observational trial.

The objectives of this study are:

1. To compare the classifications made by our machine learning system with those by physicians to assess the model's reliability and accuracy;
2. To evaluate Covid-19-related hospitalizations or deaths from any cause through day 28;
3. To determine if the machine learning system's recommended prescription alleviates symptoms of Covid-19, Post-Acute Sequelae of SARS-CoV-2 infection, and influenza;
4. To monitor participants who tested positive for the Covid-19 for 28 days after initiating treatment, looking for potential rebound cases.

Participants will use an online application to receive the recommended prescription results and will forward these results to a physician for verification. Patients are instructed to complete the online analysis every 3 days or whenever their symptoms change, whichever comes first. They are also asked to adhere to the prescribed medication regimen. Research physicians will conduct follow-ups with patients every 3 days via phone calls. The potential treatments patients may receive include any of the following Traditional Chinese Medicine formulas: LizCovidCure-1, LizCovidCure-2, LizCovidCure-3, LizCovidCure-4, and LizCovid-5.

Eligibility Criteria:
Inclusion Criteria:

* Either male or female (14 years or older), and their COVID-19 vaccination status was not a factor for inclusion.
* Subjects with any high-risk conditions
* Subjects with positive sars-cov-2 rapid antigen results in 30 days
* Subjects with post Covid-19 syndrome

Exclusion Criteria:

* pregnant individuals
* subjects with known histories of allergic reactions to medical herbs commonly used in Traditional Chinese Medicine (TCMs)
Post-Authorization Safety Study to Assess the Safety of Vimpat as add-on Therapy in Patients With Partial-onset Seizures

SP942 is a non-interventional post-authorization safety study (PASS) to evaluate the long-term safety and tolerability of Vimpat® (Lacosamide, LCM) as add-on treatment in patients with Epilepsy 16 years and older with partial-onset seizures who are uncontrolled on current therapy. Using reported adverse events, the incidence of certain cardiovascular and psychiatric events will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* This study includes any subject 16 years or older who has an Epilepsy diagnosis with Partial-Onset Seizures; and whose Seizure activity is uncontrolled on current therapy
* Patients who are prescribed Vimpat or any other add-on Antiepileptic Drug (AED) may be included in the study
* The initiation of an add-on AED therapy can not be more than 2 days before the patient's start of the study

Exclusion Criteria:

* N/A
Alberta Project Promoting Active Living and Healthy Eating in Schools

The objectives were to 1) make students eat healthier and be more active; and 2) prevent overweight and obesity. Children will therefore be less likely overweight or obese. Beginning in January 2008, the Alberta Project Promoting active Living and healthy Eating in Schools (APPLE Schools) was implemented in 10 schools throughout the Canadian Province, Alberta. Full-time School Health Facilitators were placed in each of the schools to implement what is know in Canada as Comprehensive School Health (CSH). In the United States, CSH is more commonly referred to as "Coordinated School Health", while the synonymous term "Health Promoting Schools" is often used in Australia and Europe. The project was evaluated annually in the spring from 2008 to 2011 and as of 2009 evaluations included the use of time-stamped pedometers. The comparison group included approximately 150 schools that were randomly selected to reflect the population of Alberta, Canada. Twenty of these randomly selected schools also participated in data collection which involved the use of time-stamped pedometers.

The Alberta Project Promoting active Living and healthy Eating in Schools (APPLE Schools) is a quasi-experimental pre-post trial with a non-equivalent parallel control group. The intervention began in January 2008 and lasted through June 2011 and was implemented school-wide. As out primary interest is to reduce the prevalence of overweight and obesity in schools, the essential comparisons were across grade five students in differing calendar years. At each survey all grade five students were invited to participate. The current design allowed intervention effects to be assessed over time at the school-level. Surveys were administered in the spring of 2008, 2009, 2010, and 2011 in intervention schools. And in the spring of 2008 and 2011 in control schools.

Eligibility Criteria:
Inclusion Criteria:

Intervention Schools:

* school located in a socioeconomically disadvantaged neighbourhood and a demonstrated need for health promotion
* Grade five students with parent consent, who also assented to participate were included in annual evaluations

Control Schools:

* Grade five students with parent consent, who also assented to participate were included in annual evaluations

Exclusion Criteria:

Intervention \& Control Schools:

* Schools that did not receive jurisdictional approval to participate
* Grade five students who did not receive parent consent or did not provide their assent were not included in annual evaluations