cyrilzakka/clinical-trials huggingface dataset:
Estimate Rate of the Women Who Have Gestational Diabetes

Retrospective study to estimate screening of the type 2 diabetes of women who had childbirth in the Hospital center Rene Dubos and having gestational diabetes.

It is recognized that pregnant women who had gestational diabetes (DG) multiplied by 7 subsequent risk of developing type 2 diabetes and this during 25 years. There is at present no formal recommendation of the High Authority for Health (HAS) as an organization of a long term screening for those women. However the recommendations of CNGOF (French Council of Gynaecologists and Obstetricians) and SFD (French society of diabetes) recommend screening for type 2 diabetes after a gestational diabetes in the postnatal consultation. But today how many women views due to a gestational diabetes have realized their screening? It is likely that the rate of occurrence of type 2 diabetes after gestational diabetes is underestimated today. Otherwise it is possible that the occurrence of type 2 diabetes is associated with some risk factors such as high BMI, insulin therapy during pregnancy. Another interrogation is the role of the doctor to reduce the number of women who do not realize their screening at 3 months postpartum. Better awareness of the importance of long term monitoring would reduce the proportion of women who do not realize their screening.

Eligibility Criteria:
Inclusion Criteria:

* Participants aged over 18 years
* Participants who deliver between 01/01/2013 and 30/06/2015
* Participants who have had a gestational diabetes
* Participants who have been informed and have returned the questionary

Exclusion Criteria:

* Participants who do not wishing to participate in the study
Comparing Pain and Bruising of Subcutaneous Heparin Injection

Subcutaneous heparin injection is one of the most frequent nurses' clinical care. This study aimed to Identify and compare the effects of four different injection duration on pain and bruising associated with subcutaneous injection of heparin in 90 patients. Four injection methods were used for them:

A: 10s injections duration

B: 10s injection duration and waiting 10s before withdrawing the needle

C: 15s injection duration and waiting 5s before withdrawing the needle

D: 5s injection duration and waiting 15s before withdrawing the needle.

Bruising was measured by a flexible millimeter ruler 48h after each injection; and pain was measured by pain visual analogue scale immediately after the injection. Data will be analyzed by SPSS.


Eligibility Criteria:
Inclusion Criteria:

* Inclination to participate in the study; filling out the form of conscious satisfaction
* Ability to answer the questions and determining the rate of pain
* Not being affected by blood clotting difficulties, tissue damages, injuries, and bruises in the site of injection.

Exclusion Criteria:

* Death,
* Discharge
sFlt1: a Biomarker of Organ Dysfunction in Critically-ill Patients With COVID-19?

Short description of the protocol intended for the lay public. Include a brief statement of the study hypothesis (Limit : 5000 characters) The management of critically-ill patients with organ failure due to COVID-19 represents a major healthcare burden. While endothelial inflammation has been reported in these patients, the pathophysiological mechanisms remain incompletely elucidated.

Extended description of the protocol, including more technical information (as compared to the Brief Summary) if desired. Do not include the entire protocol; do not duplicate information recorded in other data elements, such as eligibility criteria or outcome measures. (Limit : 32 000 characters)

The soluble fms-like tyrosine kinase 1 (SFlt1) is the soluble form of VEGF-A receptor 1 (VEGFR1). By linking VEGF-A with a high affinity, sFlt1 blocks the VEGF-A / VEFR1 axis and impairs endothelial homeostasis. Its production increases during inflammation. We hypothesize that sFlt1 is upregulated and correlates with endothelial dysfunction and outcomes in critically-ill patients with COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Patient with documented COVID-19 (positive PCR)
* Hospitalized in University Hospital of Reims
* Patient or family who have previously consented

Exclusion Criteria:

* Patient \<18 yo
* Patient not insured under the French social security
Data Base Project for Acquisition of Cancer Patient Data in Practices and Ambulant Therapy

The purpose of this registry is to evaluate the situation regarding ambulant therapy of cancer patients in different practices in Germany. It should provide insight into the implementation of schemes for cancer therapy predefined in the guidelines, the treatment of diverse adverse reactions and the counter measures taken. Thereby, potential differences in treatment and with that differences in quality amongst individual practices might be identified. The medium to long term aim is to contribute to positively influence the quality of medical care of cancer patients in Germany.


Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Tumor disease (carcinoma of either breast, ovary, lung, colon, stomach, pancreas, rectum or plasmacytoma)
* Written informed consent

Exclusion Criteria: none
Effects of Proteins in Patients With Cirrhosis and Prior Hepatic Encephalopathy

The purpose of this study is to compare a normal-protein diet containing branched-chain amino acids to a low-protein diet in patients with non-terminal cirrhosis (MELD \< 25) who have developed an episode of hepatic encephalopathy within two months prior to inclusion.

Hepatic encephalopathy is a major complication of cirrhosis associated with poor prognosis and poor quality of life. Appearance of HE occurs in the setting of precipitating factors that increase plasma ammonia. The gastrointestinal tract is the primary source of ammonia, which is produced by enterocytes from glutamine and by colonic bacterial catabolism of nitrogenous sources, such as ingested proteins. This is the rationale for proposing low-protein diet as strategy to reduce ammonia production and as standard diet in patients with cirrhosis and hepatic encephalopathy. However, low-protein diet could cause wasting muscle and predispose to recurrence of hepatic encephalopathy, since muscle is an important site for extrahepatic ammonia removal.

Branched-chain amino acids have shown beneficial effects on mental state of patients with chronic hepatic encephalopathy. The possible mechanism of action may be improvement of nutritional status through induction of protein synthesis. However, role of branched-chain amino acids in treatment and prevention of acute hepatic encephalopathy is not established.

Administration of a normal-protein diet containing oral branched-chain amino acids may reduce recurrence of hepatic encephalopathy as compared to a low-protein diet.

Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis of the liver.
* Recovery from an episode of hepatic encephalopathy within two months prior to inclusion.
* Compliance with a standard diet during two weeks prior to inclusion.

Exclusion Criteria:

* End-stage cirrhosis (MELD score \> 25).
* Marked cognitive disorder (mini-mental test \< 27).
* Non-treatable hepatocarcinoma in accordance with Milan criteria.
* Comorbid conditions with a life expectancy less than 6 months.
* Neurological conditions that difficult assessment of treatment of hepatic encephalopathy (dementia, encephalitis, severe depression).
* Diseases requiring administration of a specific diet (malabsorption, chronic diarrhea, chronic pancreatic insufficiency, severe obesity).
* No acceptation of written consent.
Advanced Diffusion Imaging in Renal Cancer Patients

The objective of this study is to apply advanced diffusion imaging in a two-pronged assessment of renal mass patients: (1) characterization of lesion malignancy and subtype, and (2) prediction of renal function stability or decline following partial nephrectomy.


Eligibility Criteria:
Inclusion Criteria:

* Renal mass patients scheduled for laparoscopic partial nephrectomy.
* eGFR above 30 ml/min/m2.
* Ages 21 to 85
* Must be willing and able to provide consent.

Exclusion Criteria:

* All metal implants and dental implants that have ferromagnetic properties and are unsafe at 3.0 T.
* Pregnant women are not eligible for participating in this study.
* Acute claustrophobia
hiSG Sleep Health Study

The hiSG Sleep Health Study seeks to investigate the efficacy of education + goal-based programmes for the promotion of healthy sleep habits and to evaluate its impact on daytime sleepiness and mental health.

This study is a sub-study under the existing Health Insights Singapore study (hiSG). The hiSG study is a longitudinal cohort study among working adults (aged 21-42y), monitoring health parameters through a Fitbit tracker and mobile phone-based questionnaires.

The hiSG Sleep Health Study (hiSG SHS) sub-study, will evaluate the efficacy of two goal-based interventions for improving sleep. Participants will be recruited from the existing hiSG subject pool (target N=300), and should have a habitual sleep duration below the recommended 7h (as determined from the currently available hiSG data). Following informed consent, participants will be randomized by the study team into two groups, a) Goal-Setting and b) Tracking, based on a 2:1 ratio, i.e. in the event 300 participants are enrolled, 200 will be allocated to Goal-Setting and 100 to Tracking.

The study is 22 weeks long and will proceed in 3 main phases, namely, 1) Baseline (Week 1-2) 2) Intervention (Week 3-12), and 3) Follow-up (Week 13-22).

Throughout the study, participants in both groups will be rewarded for logging their nightly sleep sessions regularly on their study wearable device, based on a weekly completion bonus for a minimum of 3 nights of sleep preceding weekdays (Sunday - Thursday nights) per week.

Daily questionnaires probing daytime sleepiness, mood, and stress levels as well as once-per-study phase sleep health, sleep hygiene, work-related stress and mental wellbeing questionnaires will be pushed to participants during the baseline (Week 1-2), intervention (Week 11-12) and follow-up periods (Week 21-22) via the hiSG mobile application. Participants will also be reimbursed for completion of these questionnaires.

Both groups will also receive sleep education tips before the intervention period. During the intervention phase, the Goal-Setting group will be additionally rewarded for achieving sleep goals, i.e. 30 mins longer than their habitual sleep duration and sleeping before midnight.

In addition, given the pervasive telecommuting arrangements presently enforced in many workplaces to curb spread of the COVID-19 pandemic, a work-life balance, burnout and work engagement questionnaire will be administered to better understand reasons that could contribute to poor sleep health and mental wellbeing.

Eligibility Criteria:
Inclusion Criteria:

* Existing participants in the hiSG study
* Aged 21-42y
* Sleep \<7h habitually on weekdays

Exclusion Criteria:

* Shift workers
* Those required to work in different time zones
* Currently Pregnant
* Nursing mothers
CATHETER ANALGESIA TRIAL Phenazopyrdine vs. Placebo: a Randomized Controlled Trial

The primary aim of this randomized clinical trial is to compare the utility of phenazopyridine HCl vs. placebo in reducing catheter-associated discomfort during the post-operative period in the gynecologic patient using mean VAS measurments.

This is a randomized clinical trial to determine whether phenazopyridine HCl reduces catheter-related bladder discomfort, using mean VAS scores and overall pain medicine requirements in women catheterized following in-patient gynecologic surgery.

Hypothesis and Aims:

We plan to test the null hypothesis that there is no difference in post-operative pain as measured by VAS pain scores and pain medication requirements in women with a Foley catheter following gynecologic surgery that are given phenazopyridine HCl vs. placebo.

The primary aim of this randomized clinical trial is to compare the utility of phenazopyridine HCl vs. placebo in reducing catheter-associated discomfort during the post-operative period in the gynecologic patient using mean VAS measurements.

Eligibility Criteria:
Inclusion Criteria:

1. Adult women undergoing gynecologic surgery who are expected to tolerate oral medication within 12 post-operative hours and require an indwelling catheter for a minimum of 12 post operative hours after start of oral medication.

Exclusion Criteria:

1. Hypersensitivity to phenazopyridine products (Defined as a having a previous anaphylaxis reaction to phenazopyridine products).
2. Known contraindications to phenazopyridine HCl:

   * Renal failure or insufficiency (Defined as having abnormal renal function on previous laboratory testing (BUN/Cr) or as having a known renal disease).
   * History of hepatic disease or failure (Defined as having known liver disease or having elevated LFTs on previous laboratory testing. Patients who would not otherwise have such testing are not required to undergo special study labs).
   * Known glucose-6-phosphate dehydrogenase deficiency.
3. Simultaneous suprapubic catheterization.
4. Inability to take oral medication within 12 hours after surgery.
5. Pregnant women.
Evaluation of Thromboprophylaxis Appropriateness in Hospitalized Medical Patients

Considering observational studies that suggested a relationship between acutely ill medical patients and venous thromboembolism (VTE), interventional studies with anticoagulant medications indicated a marked decline in VTE during and after hospitalization. Despite the therapeutic value of lowering this result, there is a low inclination to utilize anticoagulants in patients hospitalized for acute medical diseases. This observational research aims to assess the appropriateness of venous thromboprophylaxis offered to patients admitted to internal medicine wards.

Epidemiological studies have shown a significant prevalence of thromboembolism in patients admitted to medical wards.

Based on this, various clinical studies using anticoagulants such as unfractionated heparin (UFH), low-molecular-weight heparin (LMWH), and fondaparinux to prevent thromboembolism have been conducted in patients hospitalized for acute medical illness.

Interventional studies have repeatedly shown that anticoagulant prophylaxis lowers the incidence of deep venous thrombosis (DVT), pulmonary embolism (PE), and DVT-related mortality.

These findings led to recommendations to employ anticoagulant prophylaxis in patients hospitalized for acute medical disease; yet, anticoagulant prophylaxis is often underutilized in-hospital medical wards.

This study's primary objective is to assess the adequacy of venous thromboprophylaxis delivered to medical inpatients who need pharmacologic intervention in accordance with the American College of Chest Physicians (ACCP) guideline using the Padua prediction score.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Hospitalized for any cause in the internal medicine ward
* Ability to give informed consent, as informed by the physicians in charge of the patient

Exclusion Criteria:

* Expected hospital stay \< 48 h
* Patients unable to give informed consent, as informed by the physicians in charge of the patient
* Patients with therapeutic anticoagulation at hospital admission
* Patients admitted for a disease requiring therapeutic anticoagulation
* Patients admitted to non-medical hospital wards
A Prospective Randomized Double-Blind Trial Comparing 3 Doses of Intravenous Ketorolac for Pain Management

Hypothesis: Intravenous administration of Ketorolac in a dose of 10 mg is as effective in treating severe acute pain in patients presenting to the ED as 15 mg and 30 mg.

Ketorolac tromethamine is a non-steroidal anti-inflammatory drug (NSAID) that is widely used in the Emergency Department (ED) for the treatment of moderate-to-severe pain. Ketorolac is available in both oral and parenteral forms and possess significant analgesic potency. However, ketorolac provides few advantages over other currently available analgesics and its use is limited by a virtue of having an "analgesic ceiling" with the dose being 10mg as well as having a range of severe side effects, of which gastrointestinal hemorrhage is most concerning.The concept of an analgesic ceiling is that doses beyond this value (10mg) do not provide additional analgesia and do contribute to side effects. In spite of this, the majority of research conducted on ketorolac in the ED and recommendations in Tintinalli's Emergency Medicine Textbook advocating for use of three-to-six fold higher dosages.

Hypothesis: Intravenous administration of Ketorolac in a dose of 10 mg is as effective in treating severe acute pain in patients presenting to the ED as 15 mg and 30 mg.

Eligibility Criteria:
Inclusion Criteria:

Severe flank and abdominal pain, severe musculoskeletal pain (traumatic and non-traumatic in origin), headache, dental pain.

Exclusion Criteria:

Age \>65, Active Peptic Ulcer disease, Acute Gastrointestinal Hemorrhage, Known Hx of Renal or Hepatic insufficiency, Hx of allergies to NSAIDS.
Preventing Cardiovascular Collapse With Vasopressors During Tracheal Intubation

Tracheal intubation (TI) is associated with a high risk of adverse events in critically ill patients and peri-intubation hemodynamic collapse is the most commonly observed. The primary aim of the PREVENTION trial is to compare the effect of the pre-emptive use of noradrenaline versus no peri-intubation use of noradrenaline on incidence of cardiovascular collapse following TI in adult critically ill patients. Patients with absolute indication or contraindication to vasopressor support will be excluded from this trial. Patients will be randomized 1:1 to a continuous infusion of noradrenaline started before induction titrated according to baseline mean arterial pressure. The primary outcome will be the incidence of cardiovascular collapse. Secondary outcomes will include lowest systolic blood pressure and cardiac arrest within 30 minutes from intubation.

PREVENTION trial is a pragmatic, multi-center, un-blinded, parallel group, randomized study comparing the pre-emptive use of noradrenaline to no-vasopressors during the peri-intubation period of adult critically ill patients. Investigators hypothesize that the pre-emptive administration of noradrenaline would mitigate the incidence and severity of peri-intubation cardiovascular collapse. The study will include adult (18 yrs or older) critically ill patients needing in-hospital intubation, excluding patients with absolute indication or contraindication to vasopressors. Patients will be randomized to receive either a continuous infusion of noradrenaline started at least 8 minutes before induction vs no vasopressors during the peri-intubation period. All co-interventions will be provided according to clinician's judgement. The primary outcome of the study will be a composite of MAP \< 60 mmHg or cardiac arrest. Secondary outcomes will include lowest systolic blood pressure \< 30 minutes from induction, change in systolic blood pressure from baseline to the lowest value within 30 minutes from induction and cardiac arrest.

Eligibility Criteria:
Inclusion Criteria:

* Patient is admitted or scheduled for admission to a participating study hospital
* Planned procedure is tracheal intubation and planned operator is a provider expected to routinely perform endotracheal intubation in the participating unit
* Critical illness (i.e. life-threatening condition with intubation required for cardiorespiratory failure or neurological impairment)
* Administration of sedation (with or without neuromuscular blockade) is planned
* Age 18 years or older

Exclusion Criteria:

* No vasopressors/inotropes at the moment of screening for eligibility
* MAP \< 60 mmHg or \> 120 mmHg at the moment of screening for eligibility
* Urgency of intubation precludes safe performance of study procedures
* Intubation performed during cardiopulmonary resuscitation of a patient in cardiac arrest
* Enrolled in another clinical trial that is unapproved for co-enrollment
* Pregnant or suspected pregnancy
Irinotecan in Treating Young Patients With Refractory or Recurrent Hepatoblastoma

RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well irinotecan works in treating young patients with refractory or recurrent hepatoblastoma.

OBJECTIVES:

Primary

* Determine the biological activity of irinotecan hydrochloride, when given on a prolonged schedule, in terms of response rate and rate of early progression, in young patients with refractory or recurrent hepatoblastoma.

Secondary

* Determine the duration of response in patients showing stable disease or an objective response (partial or complete response) to this drug.
* Determine the time to progression and overall survival of patients treated with this drug.
* Determine the rate of resectability in patients treated with this drug.
* Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive irinotecan IV over 1 hour on days 1-5 and 8-12. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

Patients undergo evaluation for tumor resectability after courses 2, 3, or 4. Patients whose disease is considered resectable at any of these time points proceed to surgery.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of hepatoblastoma

  * Refractory or recurrent disease

    * Failed prior first-line or second-line treatment
  * Metastatic disease allowed
* Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan

  * Elevated serum alpha-fetoprotein (AFP) allowed
* No hepatocellular carcinoma

PATIENT CHARACTERISTICS:

* Lansky performance status 50-100% in patients ≤ 10 years of age OR Karnofsky performance status 50-100% in patients \> 10 years of age
* Life expectancy \> 8 weeks
* Hemoglobin \> 8 g/dL
* Absolute neutrophil count \> 1,000/mm\^3
* Platelet count \> 100,000/mm\^3
* Serum bilirubin ≤ 2 times normal
* AST/ALT ≤ 2 times normal
* Serum creatinine ≤ 3 times normal
* Normal metabolic parameters (i.e., serum electrolytes, glucose, calcium, and phosphate)
* Not pregnant or nursing
* No severe uncontrolled infection or enterocolitis

PRIOR CONCURRENT THERAPY:

* Recovered from toxicity of prior therapy
* No chemotherapy within 3 weeks prior to study entry
* No prior irinotecan
* No other concurrent anticancer therapy