cyrilzakka/clinical-trials huggingface dataset:
Temperature and Mortality

The investigators evaluated the spatial association between, cardiovascular diseases (CVD) and stroke mortality rate with average ambient temperature (Ta) , and then used this relationship to model future temporal trends in mortality from CVD and stroke till the end of century (2099) using different warming scenarios across the mainland USA.

the investigators used data on mortality rate (per 100,000 individuals) for CVD and stroke (between 2011 and 2013, age\>35years) from the publicly available Centers for disease prevention and control (CDC) web site (www.cdc.gov). CVD mortality was defined as the number of deaths per 100,000 personyears due to circulatory causes (International Statistical Classification of Diseases, Tenth Revision, codes I00-I99).Oak Ridge National laboratory was the source of the ambient temperature data (http://www.daac.ornl.gov: files B01, B02 and C07).The investigators obtained data on prevalence of HTN (HTN was defined as systolic blood pressure (BP) of at least 140 mm Hg, self-reported use of antihypertensive treatment, or both) from county health rankings and roadmaps organisation (www.countyhealthrankings.org), which were estimated based on National Health and Nutrition Examination Survey in five two-year waves from 1999-2008 including 26,349 adults aged 30 years and older and from the Behavioral Risk Factor Surveillance System (BRFSS) from 1997-2009 including 1,283,722 adults aged 30 years and older.

Eligibility Criteria:
Inclusion Criteria:

1. age\>35 years

Exclusion Criteria:

None
Analgesic Efficacy of the Novel Intra- Semispinal Fascial Plane Block in Posterior Cervical Spine Surgery

Posterior cervical spine surgery often requires a large posterior midline incision, resulting in poorly controlled postoperative pain, which arises from iatrogenic mechanical damage, intraoperative retraction, and resection to structures such as bone, ligaments, muscles, intervertebral discs, and zygapophysial joints.

Ultrasound-guided Inter-semispinal plane (ISP) block, was proposed as a novel technique for analgesia in posterior cervical spine surgeries. The ISP block involves an injection of local anesthetic into the fascial plane between the semispinalis cervicis and semispinal capitis muscles and results in blocking the dorsal rami of the cervical spinal nerves. ISP block can provide effective analgesia in posterior cervical spine surgery

Eligibility Criteria:
Inclusion Criteria:

* Patients' acceptance.
* ASA I , II andIII .
* Age between 18 years up to 70 years in both sexes.
* Patients with a BMI (body mass index) ranging from 18.5 to 30 kg/m2.
* Patients who scheduled for elective posterior cervical spine surgeries

Exclusion Criteria:

* Uncooperative patients
* Coagulopathy.
* Local tissue infection.
* Allergy to local anesthesia.
Trigger Points of Supraspinatus Muscle: Osteopaths' Palpation Reproductibility and Ultrasound Translation

Trigger points (TP) are described as "hard, palpable nodules located within the taut bands of skeletal muscle" (Bardoni, 2022).

The aim of this study is to evaluate the reproductibility of palpation of TP between osteopaths and to compare this perception to ultrasound measures of echogenicity.

Method:

A sample of 61 patients will be included in the study. An osteopath will determine the eligibility of the study. The supraclavicular area will be mark every 2 cm to establish a grid for all evaluations.

First an osteopath will evaluate with palpation the presence of TP at every box of the grid.

A second osteopath will evaluate the same boxes and will be blinded to the result of the first osteopath.

At each step of palpation, a pain assessment will be carried out at each box. Then, the ultrasound technician will evaluate the echogeneicity of every box and will be blinded to the prior results.

The protocol will be approve by a french ethic committee.

sensitivity and specificity of osteopathic tests will be conducted in comparaison to echograph results (a binary outcomes assessing the presence of an hypoechogenicity).

The reproductibility of osteopaths' tests will be be calculated using Cohen's kappa weighted by the distance between the TPs found.

Finally, the pain reported by patients on areas with a TP defined by the osteopath, and the pain reported by patients on areas without a TP defined by the osteopath will be compared using a student test.

Eligibility Criteria:
Inclusion Criteria:

* Adults (18 to 50 years old),
* affiliation to a social security scheme or beneficiary of such a scheme

Exclusion Criteria:

* pregnant and breastfeeding women,
* adults under guardianship and protected patients.
* History of integumentary or muscular involvement in the area of interest
* Allergic reaction
* wish to stop the study
SAFETIM-needs : Exploring Adolescent's and Parent's Needs During Transition in French CF Centers

prospective multicentric study protocol in french CF center, exploring adolescent avec parents needs during transition from pediatric CF center to adult CF center

Adolescent's and parent's needs will be studied, before the transition and their experiences of transition, in order to propose organizational national recommendations semi structured interview with adolescents and parents separately, before and after transition.

semi structured interviews will be conducted twice for each (adolescent and parents), the first in the 6 months before transition and the second in the 6 months after transition.

After their verbatims will be analyzed and the optimal organisation will be determined for the transition based according to their point of view.

At the end, the data from this study will be matched with data collected in a former study from care givers practices during transition in the french CF centers.

Eligibility Criteria:
Inclusion Criteria:

* CF adolescent and their parents , for whom the transition to the adult center is scheduled within six months and witch have freely agreed to participate in the interviews

Exclusion Criteria:

* none
Pre-operative Polysomnography Assessment of Cardiac Surgery Inpatients

The purpose of this study is to assess the prevalence and morbidity rates of sleep disordered breathing in cardiac surgery patients.


Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing major cardiovascular surgery (coronary artery bypass graft, valve replacement surgery, or aortic surgery) under general anesthesia.
* Subjects in whom surgery is planned for greater than 1 day but less than 60 days from the time of enrollment.

Exclusion Criteria:

* Subjects treated for sleep apnea with positive airway pressure (PAP) therapy or oral appliance in the past 30 days.
* Subjects undergoing Maze procedure for atrial fibrillation.
* Subjects unable to comply with study procedures.
Project CORE: Disseminating Eating Disorders Treatment

The goals of this project are to 1) develop training opportunities for master's-level and pre-doctoral psychology students in evidence-based assessment and treatment of adolescent EDs; 2) to provide the healthcare workforce, including licensed health professionals such as primary care physicians and behavioral health interventionists, with knowledge and competence to recognize early symptoms of and intervention strategies for EDs; and 3) to test the efficacy of delivering two evidence-based treatments for adolescent eating disorders, Family Based Treatment (FBT) and Enhanced Cognitive Behavioral Therapy (CBT-E), in the home-based setting.

The complete project will incorporate three phases. Phase I is designed to gather information from existing licensed health professionals in the community who serve Medicaid populations on their knowledge needs and priorities related to screening and intervening with patients with eating disorders. Phase I will comprise eating disorder psycho-education, implementation of workshops, and supervision among primary care professionals and mental health workers. Responses will inform the content of in-services and program development (e.g., monthly consultation services, ongoing multi-family support groups) provided in Phase II.

During Phase II, families containing a child with a restrictive-type eating disorder will be recruited to receive treatment from the clinicians assessed and trained during Phase I. Families will be assigned to receive either Family Based Treatment (FBT) or Enhanced Cognitive Behavioral Therapy (CBT-E) to treat their adolescent's eating disorder. Treatment will occur over 10-16 weeks, depending on the family's needs and availability. Families will be assessed at pre-treatment, post-treatment, and 1-year follow-up.

Phase III will consist of follow-up with the families and clinicians, and further development of training/education approaches for the Rhode Island healthcare workforce.

Eligibility Criteria:
Inclusion criteria include:

* meets criteria for AN, atypical AN, or BN according to DSM-5 diagnostic criteria
* is currently living at home
* is medically stable for outpatient treatment according to the recommended thresholds of the American Academy of Pediatrics and the Society of Adolescent Medicine (e.g., ≥75% of expected body weight, heartrate ≥50 beats per minute)
* if on a psychotropic medication, meets all eligibility criteria while on stable dose of psychotropic medication (8 weeks) for a co-morbid condition
* speaks English
* be available for long-term follow-up.

Exclusion criteria include:

* associated physical illness that necessitates hospitalization
* psychotic illness/other mental illness requiring hospitalization
* current dependence on drugs or alcohol
* physical conditions (e.g. diabetes mellitus, pregnancy) known to influence eating or weight
* concurrent involvement in other psychological treatment for an eating disorder
* developmental delay that would preclude participation in the intervention.
Cardio-protective Effect of Metformin in Patients Undergoing PCI

This is a two-arm randomized parallel study. Patients who will be meeting the above-mentioned criteria and agree to take part in the study, were asked to sign an informed consent prior conducting the study.

The whole study protocol were presented to the local institutional review board (IRB).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (age above 18)
* Undergoing elective PCI

Exclusion Criteria:

1. Hypersensitivity to metformin or any component of the formulation
2. Patients with current or any history taking metformin either for diabetes mellitus or any other reason such as polycystic ovarian syndrome.
3. Patients diagnosed with type 1 or 2 diabetes mellitus.
4. Any oral or injectable hypoglycemic therapy (e.g. insulin, sulfonylureas)
5. Severe renal dysfunction (eGFR less than 30 mL/minute/1.73 m2 ) from any cause, including shock or septicemia; acute or chronic metabolic acidosis with or without coma (including diabetic ketoacidosis).
6. Treatment with systemic glucocorticoids within 3 months of randomization (due to its potential effect on plasma glucose and HbA1c levels).
7. Metabolic acidosis (total CO 2 below the laboratory lower limit of normal on most recent blood chemistry panel).
8. Need for coronary artery bypass grafting.
9. Participation in other clinical trial in the 30 days before enrollment.
10. The existence of a life-threatening disease with a life-expectancy of less than 6 months.
MACOCHA Score Predicts Intubation Failure

Risk factors for difficult intubation are well described in anesthesiology. But intubation in the intensive care unit (ICU) is a challenging issue, associated with severe life-threatening complications. Non-anesthesiologist trainees performing ICU intubation may not fully appreciate the potential difficulty and complications.

Therefore in this retrospective analysis the MACOCHA score will be used to determine difficult intubation in the ICU and predict intubation failure.


Eligibility Criteria:
Inclusion Criteria:

* patients intubated in the ICU
* \>18 years of age

Exclusion Criteria:

* \<18 years of age
Modulation of Abeta Levels by GSK933776 in Alzheimer's Disease Patient

Modulation of beta-amyloid levels in CSF and plasma by GSK933776 in patients with mild Alzheimer's disease or mild cognitive impairment

This is a phase I, an open label, single dose and parallel group study to assess short term pharmacodynamics and safety of GSK933776. The effect on the beta amyloid levels will be assessed in early (MCI) and mild Alzheimer's disease (AD) patients after a single dose of GSK933776 by i.v. administration.

Eligibility Criteria:
Inclusion Criteria:

* Probable mild Alzheimer's disease (MMSE 20-26) or mild cognitive impairment
* Increase in total tau or p-tau in CSF
* Decrease in amyloid beta in CSF
* Stable dose of cholinesterase inhibitors, memantine or selegine or no treatment
* Body weight less than 120 kg
* Willingness to comply with contraceptive methods if self or partner is of child-bearing potential

Exclusion Criteria:

* Any other cause of dementia
* Other significant neurologic or psychiatric illness
* Hachinski Ischemia Score \>4
* More than 3 microbleeds on MRI
* Type 2 diabetes not controlled by diet
* Risk of cerebrovascular disease, cerebral haemorrhage or stroke
* History of systemic autoimmune disease
* Use of platelet anti-aggregates or anti-coagulants (Aspirin up to 325 mg/day is allowable)
* Use of chronic corticosteroids
* Uncontrolled hypertension in spite of antihypertensive medications
* Renal or hepatic insufficiency or clinically significant anaemia
* In nursing home care
* Contraindications to lumbar puncture or MRI
* Prior participation in therapeutic studies only after adequate wash-out period
Stroke Observatory of Caen-Normandie Metropole

Stroke Observatory of Caen-Normandy Metropole provides epidemiological data in prospective collection. The primary objective is to determinate incidence of Stroke in this area. Several data sources will be crossed to allow an exhaustive identification of the cases. No intervention will be carried. The data collected will correspond to those obtained in current practice. The number of participants is estimated at 800 per year. This Observatory aims to become a qualified population register after three years, according to requirement of the french registry evaluation committee.

Stroke is the second leading cause of death (the first in women in industrialized countries), the second cause of dementia and the third leading cause of disability. For a middle-aged person, the risk of developing a stroke is 1/5 in women and 1/6 in men over a lifetime. Moreover, stroke is a disease that can be considered chronic. Indeed, in France, the survival rate one month after a stroke is 80-90%. However, at least 50% of survivors retain a severe disability and almost all require long-term care. The medico-economic impact of stroke is therefore important in both the initial and chronic phases. Nevertheless, none of the French stroke registries consider the burden of post-stroke disability. In addition, there is limited data available on the impact of geographic disparities on the prognosis of stroke. Population studies are essential to accurately identify the incidence and burden of stroke, thereby supporting public health policy, guiding the allocation of resources, and evaluating the effectiveness of preventive strategies for a population. This is why we propose to create a Norman Observatory of Stroke. It will include an urban and rural population and will aim to become a population register.

Eligibility Criteria:
Inclusion Criteria:

* Any types of strokes (initial, recidivism)
* Place of residence in Caen-Normandie Metropole
* Age higher than 30 days (exclusion of perinatal stroke)

Exclusion Criteria:

* None, unless patient opposition
Aquamid Reconstruction for Osteoarthritis of the Knee

Osteoarthritis (OA) causes degradation and deformities of joints, including knees, hips, hands, and feet. Approximately more than 55% of populations above 45 years and more than 70% of population above 70 years will develop OA in at least one joint. The symptoms are dominated by pain but also stiffness and swelling occur. There is currently no cure for OA, and the ultimate treatment is joint replacement surgery. However, there is an unmet need to identify other treatment options that may delay or avoid surgery.

Aquamid Reconstruction (AR) is a polyacrylamide hydrogel (PAAG) which is a non-degradable, highly visco-elastic synthetic gel, which is atoxic with durable effect and tissue-compatibility and well tolerated by mammal tissue by allowing in vivo vessel and fibrous in-growth. Experimental studies supported by histopathological observations have shown that AR exerts its effect via integration over time within the soft tissues, through a combination of vessel in-growth and molecular water exchange. Intra-articular injection of AR is expected to provide permanent pain relief and improve the functional ability through a cushioning or padding effect on the joint and thereby reduce symptoms and improve patients' quality of life.

The purpose of this study is to obtain information of the safety and effectiveness of AR in patients with OA of the knee.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* WOMAC pain score \>/= 5
* Kellgren and Lawrence radiographic scoring \>/= 1
* Signed informed consent form

Exclusion Criteria:

* Other diseases affecting the joints such as rheumatoid arthritis
* Actual or recurrent infections requiring intravenous antibiotic treatment within the last 30 days or oral antibiotic treatment within the last 14 days before inclusion
* Less than 12 weeks since injection of HA or corticosteroids in study-knee joint before treatment
* Pregnancy or lactation
* Not able to comply with the requirements of the study
* Previous alloplasty
Magnesium Replacement and Hyperglycemia After Kidney Transplantation

The insulin receptor is dependent on magnesium and hypomagnesemia is associated with increased insulin resistance and decreased insulin secretion and action. Recent data suggest that hypomagnesemia may play a role in development of type 2 diabetes. Kidney transplantation patients have low plasma magnesium levels, partly due to treatment with calcineurin inhibitors. However, the role of magnesium in the development of post-transplant diabetes mellitus (PTDM) is unclear.

The present study addresses, whether hypomagnesemia is feasible to reverse by oral administration of magnesium.

The investigators wish to investigate whether oral magnesium supplementation is sufficient to increase magnesium levels in kidney transplant recipients, and if supplementation improves glycemic parameters as measured by an oral glucose tolerance test (OGTT).


Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant recipients more than one year after transplantation
* Hypomagnesemia (\< 0.7 mmol/L)
* Age ≥ 18 years and able to give written informed consent

Exclusion Criteria:

* Current treatment with magnesium containing medication or supplements
* Current medical treatment for diabetes
* Conditions impairing magnesium absorption from the gastrointestinal tract (e.g. short bowel syndrome, chronic pancreatitis)
* Subjects with primary non-graft function and subjects with need of dialysis therapy \>2 months or graftectomy at any time point after transplantation
Personality Style and Self Compassion in Postpartum Depression: An Online Prevention Study

The primary aim of this study is to assess the relationship between personality style, self-compassion and depression during pregnancy, to identify psychological risk factors, particularly personality styles, that may contribute to the onset of PPD. Additionally, the study will provide support for the effectiveness of Internet-based Compassionate-Mind Training (iCMT) as a prevention intervention for Postpartum Depression (PPD) for women in the 2nd and 3rd trimester of pregnancy. The study will also assess differences along personality predictors and depression severity as they relate to intervention outcomes (i.e. depression in postpartum and self-compassion) and engagement. The researchers hypothesize that women both at high and low risk for PPD will receive benefits from the intervention, however, those who endorse more maladaptive personality traits will likely engage and benefit less than those who do not endorse these traits.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women in the second and third trimester

Exclusion Criteria:

* Under 18 years of age
* Males
* Women who are not pregnant
* Pregnant women in the first trimester of pregnancy or over 36 weeks pregnant
* Women who likely meet criteria for a Major Depressive Episode
* Women currently in in-person psychological tx
ED90 of Norepinephrine and Phenylephrine Infusions Under Intensive Treatment in Preeclamptic Patients

The objective of this study is to investigate the ED90 of norepinephrine and phenylephrine infusions for preventing postspinal anesthesia hypotension under intensive treatment in preeclamptic patients during cesarean section

Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. The 2016 ASA guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage post-spinal anesthesia hypotension. The 2018 International Consensus in the United Kingdom and Northern Ireland recommends maintaining maternal systolic blood pressure above 90% of the baseline value following lumbar anesthesia, while avoiding dropping below 80% of the baseline value. Currently, the threshold for maintaining blood pressure above 80% of the baseline value is widely adopted as a standard; however, limited evidence supports the advantage of sustaining maternal blood pressure above 90% of the baseline value. The objective of this study is to investigate the ED90 of norepinephrine and phenylephrine infusions for preventing postspinal anesthesia hypotension under intensive treatment in preeclamptic patients during cesarean section

Eligibility Criteria:
Inclusion Criteria:

* 18-45 years
* Primipara or multipara
* Singleton pregnancy ≥32 weeks
* American Society of Anesthesiologists physical status classification I to III
* Scheduled for cesarean section under spinal anesthesia

Exclusion Criteria:

* Baseline blood pressure ≥160 mmHg
* Body height \< 150 cm
* Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
* Eclampsia or chronic hypertension
* Hemoglobin \< 7g/dl
* Fetal distress, or known fetal developmental anomaly
Prophylactic Lidocaine Spray for Pain Alleviation in Women Undergoing Osmotic Dilator Insertion for Second Trimester Dilatation and Evacuation

To examine whether application of lidocaine spray in cervical preparation for second trimester dilatation and evacuation alleviates pain and is superior to current protocol of preparation without analgesia and superior to placebo.

a double- blind, randomized, placebo- controlled trial, performed at a single tertiary medical center. Eligible participants aged 18 and older and about to undergo dilation \& evacuation of the uterus between 12 to 24 weeks of gestation. Participants will be randomized using computer generated allocation to receive 10% Xylocaine (lidocaine group) spray or normal saline 0.9% (placebo group), applied identically topically to the endocervix and ectocervix before laminaria insertion. The primary outcome will be the participant's reported pain score immediately after the first laminaria was inserted as measured on a 10 cm visual analog scale (VAS). Secondary outcomes wiil be reported pain scores at speculum removal, 15 minutes after speculum insertion and immediately before the D\&E procedure.


Eligibility Criteria:
Inclusion Criteria:

* • Informed consent

  * Women with a gestational age of 12-24 weeks by last menstrual period.

Exclusion Criteria:

* • CRL assesed by ultrasound as \<10 weeks

  * Clinical Uterine size \>24 weeks
  * Fetus Bi Parietal Diameter \> 50 mm
  * Known amide allergy