cyrilzakka/clinical-trials huggingface dataset:
Head-to-pelvis Computed Tomography Evaluation of Sudden Death Survivors

Out-of-hospital arrest can occur from multiple etiologies. In patients without an obvious reason for the sudden-death event, diagnostic evaluation is not clear. This study is to determine if early imaging with a head-to-pelvis CT scan may improve diagnostic accuracy, speed of diagnosis and potentially clinical outcomes.

Best practices for survivors of out-of-hospital sudden death are underdeveloped and untested. Early diagnosis in sudden death survivors is challenging due to patient intubation and obtundation, limited history, and imprecise standard of care testing. Sudden death without an obvious cause (termed "idiopathic sudden death") is primarily caused by cardiovascular disease although a large number of cases result from non-cardiac disease. Improvements in computed tomography (CT) technologies provides a means to identify up to 86% of idiopathic causes of sudden death, including cardiovascular and coronary artery disease, cerebral disease, pulmonary embolism and abdominal catastrophe4 as well as secondary injury from cardiopulmonary resuscitation. To date, use of early CT scans on consecutive sudden death survivors has not been reported. The innovation of this pilot trial is to be first to test whether a comprehensive head-to-pelvis, ECG-gated contrast CT scan (CT-First) can identify the majority of causes for idiopathic sudden death. The significance of CT-First approach is potentially reducing diagnostic errors, treatment delays and inappropriate treatments to potentially improve clinical outcomes in this very high risk population. The expertise of the medical centers involved, combined with the highly respected Medic One service, provide an unusual opportunity to test this diagnostic paradigm with cutting edge CT technologies. The data generated from this study will be used to plan larger randomized trials of early contrast CT scanning versus invasive coronary angiography in sudden death survivors and may be extrapolated to other patient populations such as possible acute coronary syndrome or after trauma.

Eligibility Criteria:
Inclusion Criteria:

1. Patients reaching the Emergency Department within 6 hours of resuscitated sudden death.
2. No obvious cause for sudden death event with initial standard of care clinical evaluation
3. Clinically stable to have CT performed per treating physician
4. Candidates for continued intubation and sedation during the CT scan with or without therapeutic hypothermia protocol.

Exclusion Criteria:

1. Meets criteria for acute ST elevation myocardial infarction (ST elevation ≥1 contiguous lead or new or unknown duration left bundle branch block on ECG) or has other indication for ICA
2. Obvious cause of sudden death - Examples: witnessed trauma, drowning, suicide attempt
3. Known non-revascularized coronary artery disease or coronary stent \<2.5 mm.
4. Known severe renal dysfunction (eGFR\<30 ml/hr, creatinine \>1.7 mg/dl)
5. Implantable defibrillator, due to metal artifact from defibrillator coil
6. Known iodinated contrast allergy
7. Known hospice patient or terminal disease with expected \<3 months survival
Catheter Dislocation and the Influence of Different Catheter Fixation in Pediatric Patients

Insertion of intravenous or intra-arterial catheter is one of the most common procedures in anesthesiology and intensive care medicine. After successful insertion, proper catheter fixation is required to maintain the catheter correct position with the aim to preserve catheter patency, prevent excessive movements of catheter or even iatrogenic catheter extraction/dislocation. Beside the historically preferred surgical fixation to the skin of the patient (invasive method, repeated percutaneous punction), atraumatic fixation by special dressing is currently available in clinical practice. In pediatric patients, due to limited cooperation, higher risk of dislocation exists.

Pediatric patients with intravenous and/or intraarterial catheters with estimated length of insertion over 72 hours will be included into the trial.Type of catheter fixation (surgical versus atraumatic) will be evaluated. Demographic data, local and systemic complication between the group of surgical fixation and atraumatic fixation will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* pediatric patients with intravenous/intraarterial catheter secured at Departement of pediatric anesthesiology and intensive care medicine
* estimated length of catheter left in place longer than 72 hours

Exclusion Criteria:

* estimated length of catheter left in place shorter than 72 hours
* impossible patient´s evaluation after catheter insertion
Cohort Study to Determine the Long-Term Safety and Efficacy of Biogeneric Epoetin Treatment for Renal Anemia

The purpose of this study is to establish the long-term safety and efficacy of Biogeneric Epoetin, the attainability of therapeutic target for anaemia management, and the impact of Epoetin treatment on long-term health outcome and its cost effectiveness.

This study protocol is an elaboration of the original study protocol titled "A Randomized, Multi-center, Open label trial to establish the therapeutic equivalence between Biogeneric Epoetin and Eprex and to determine the long term safety profile of Biogeneric Epoetin in patients on Hemodialysis".

In the first stage, a biogeneric Epoetin shall be evaluated by a randomized trial designed to demonstrate therapeutic equivalence (TE) versus an innovator product (Eprex), the efficacy clinical end-point being Hb at 6 to 12 weeks on treatment.

When preliminary evidence of efficacy is established from above stage 1 TE trial, the product may proceed to be evaluated in a stage 2 single group cohort study designed to establish the long term safety, with particular emphasis on surveillance for occurrence of Pure Red Cell Aplasia (PRCA) and other immunogenicity related adverse event. To establish the long term efficacy, its emphasis on the potential impact of batch to batch variation in product content and potency (bioactivity) on Hb response.

This practical trial also designed to investigate the cost-effectiveness by estimating the optimal dosage for combination of Epoetin and Iron sucrose to achieve Hb target under unconstrained prescriptionas, and hence the budgetary requirement can be estimated to meet therapeutic target in this dialysis population under various pricing scenario in the presence of generic competition.

Eligibility Criteria:
Inclusion Criteria:

* Patient who has Chronic Kidney Disease with anaemia for which Epoetin treatment is indicated.
* Patient without known hypersensitivity to the mammalian cell-derived product or human albumin products.
Point-of-care Ultrasound in Prehospital Dyspnea

Point-of-care ultrasound in patients with dyspnoea has been shown to alter patient treatment and the time to correct treatment when performed in emergency departments. In Denmark, physician-staffed ambulances are sent to citizens with severe ABCD symptoms including dyspnoea. Hence, there is a potential for correct diagnostics and appropriate treatment already in the citizens' own home or en route to the hospital. This study aims to evaluate the clinical performance of prehospital point-of-care ultrasound in patients with dyspnoea.


Eligibility Criteria:
Inclusion Criteria:

* age \>/= 18 years
* dyspnea as a dominating complaint At least one of
* respiratory frequency \>25/minute
* oxygen saturation \< 95%
* oxygen therapy initiated

Exclusion Criteria:

* trama patients
* prior enrollment
Pregnenolone in the Management of Schizophrenia Patients

Pregnenolone is a "neurosteroid" and possesses intrinsic behavioral and brain effects in animals, affecting the GABA(A) and other receptors. Pregnenolone is serves as the precursor for dehydroepiandrosterone (DHEA) and its sulfate ester (DHEAS). There is evidence of efficacy of DHEA augmentation in schizophrenia, we therefore sought to examine the efficacy of augmentation of antipsychotic treatment of schizophrenia patients with pregnenolone. It is hypothesized that the combined effect of antipsychotic agents and pregnenolone would be beneficial in the treatment of negative,depressive, and cognitive symptoms.

Either pregnenolone (30 mg/d or 200 mg/d), DHEA (400 mg/d)or placebo will be added to regular treatment for 8 weeks. Subjects will be assessed at baseline and after 2, 4, 6 and 8 weeks of treatment. An extensive battery of research instruments will be used for assessment of the following domains of interest: psychopathology, insight, side effects, and cognitive functions. Plasma pregnenolone, DHEA(S), cortisol and other relevant steroids will be assayed at baseline, 2, 4, 6 and 8 weeks of treatment. Efficacy and safety of augmentation of antipsychotic treatment with pregnenolone will be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV criteria for schizophrenia or schizoaffective disorder
* Ability and willingness to sign informed consent for participation in the study

Exclusion Criteria:

* Evidence of organic brain damage, mental retardation, alcohol or drug abuse
* Prostate nodules or cancer.
* Moderate symptoms of benign prostatic hypertrophy such as hesitancy, urgency, frequent voiding and feeling of incomplete voiding.
* History of ischemic cardiac disease.
* Renal disease.
* Hepatic dysfunction.
* Women with a history of carcinoma of the breast, or any women with a family history of the following: premenopausal breast cancer or bilateral breast cancer in a first degree relative; multiple family members (greater than three relatives) with postmenopausal breast cancer.
* Women with a history of uterine cancer.
* Patients with a known hypersensitivity to androgens.
* Pregnant women.
Evaluation of the Kinesiology Taping Effectiveness in the Treatment of Lumbar Spine Pain

Lumbar spine pain syndromes are one of the most common pain conditions in our society.

The purpose of kinesiotaping is to normalize muscle function, improve blood and lymph flow, reduce pain, improve proprioception, promote tissue healing and restore normal tissue function. Today, this method is used in many fields of medicine. Its primary purpose is to support the musculoskeletal system by using various types of applications.

There is a lack of publications in the global literature on the effect of kinesiotaping of the external oblique muscles on lumbar spine pain. The main objective of this study is to evaluate the effectiveness of kinesiology taping in the treatment of lumbar spine pain in individuals under 30 years of age.

Back pain occurs in people of all ages, regardless of their job. Both blue-collar and white-collar workers are exposed to strain and pain in the lumbar spine. The presence of pain is also promoted by low physical activity, poor motor habits, as well as stress.

There are numerous factors affecting the quality of life in patients with lower back pain. These include degree of pain, physical fitness, individual factors, degree of social support, and a potential for adapting forces to match constantly changing conditions.

The contemporary functional model of lumbar spinal muscles divides them into local stabilizers, single-joint global stabilizers, and multi-joint global stabilizers. The abdominal external oblique muscles are classified as global stabilizers. They generate force to control range of motion and allow limitation of that range (eccentric control), and functionally control rotation in all movements, regardless of the load acting on the spine.

The main objective of this study is to evaluate the effectiveness of kinesiology taping in the treatment of lumbar spine pain in individuals under 30 years of age.

Eligibility Criteria:
Inclusion Criteria:

* participants' age between 18 and 30,
* the presence of pain in the lumbar region of the spine,
* participants who have not been using non-steroidal anti-inflammatory drugs (NSAIDs) for at least one week prior to study entry,
* no contraindications to the use of dynamic kinesiology taping patches,
* informed, written consent to participate in the study.

Exclusion Criteria:

* status of the post lumbar spine surgery,
* subjects who have had a spinal injury within 6 months prior to the start of the study,
* neoplastic diseases,
* congenital structural pathologies of the spine,
* allergy to the adhesive substance of kinesiology taping or paper patch,
* being a physiotherapy student.
Phase II Open Label Study Using Triheptanoin in Patients With Glucose Type 1 Transporter Deficiency GLUT1-DS

The purpose of this project is to study the efficacy of triheptanoin oil in patients with GLUT1 deficiency syndrome.

The primary objective of the study is:

- to evaluate the capacity of triheptanoïn to improve the condition of patients with GLUT1-DS

The secondary objectives of the study are:

* to confirm the short-term safety of triheptanoïn therapy in patients with GLUT1-DS
* to evaluate the short-term effects of triheptanoïn treatment on motor function, autonomy, quality of life and clinical signs of patients with GLUT1-DS
* to evaluate the effect of triheptanoïn on brain energy metabolism using non-invasive 31P-MRS spectroscopy after activation of the occipital cortex in order to measure the levels of high-energy phosphates (such as ATP and phosphocreatine)

Eligibility Criteria:
Inclusion Criteria:

* Mutation in SLC2A1 gene
* Age \> 3 years
* Patient with history/frequency of seizures or movement disorders documented at least 3 months prior to the beginning of the study
* Covered by french social security
* Patients who freely agree to participate in this study and understand the nature, risks and benefits of this study and give their written informed consent. (In addition to the requirement for the consent of parents or the legal representative, adolescents can provide additional informed consent to participate in clinical trials)

Exclusion Criteria:

* Evidence of psychiatric disorder
* Attendant neurological disorder
* Comorbid medical condition that would render them unsuitable for the study, e.g. HIV, diabetes
* Pregnant or parturient or lactating women
* Unwillingness to be informed in case of abnormal MRI
* Failure to give written informed consent
* Unable to understand the protocol
* Unable to participate to the whole study
* Absence of signed informed consent
* Persons deprived of their liberty by judicial or administrative decision
* Person subject to an exclusion period for another research
* Subjects with exclusion criteria required by french law
French Prospective Observational Study in Patients Eligible for Systemic Therapy for Atopic Dermatitis (AD)

The objective of the study is to describe the therapeutic management of patients more than or equal to 18 years old eligible for systemic therapy or treated by systemic therapy for atopic dermatitis (AD). This study will be proposed to a sample of French dermatologists experienced in the management of AD, practicing in hospital centers and/or office-based dermatologists. The study will be conducted in real conditions of practice, systemic treatment decisions will be taken at the sole initiative of the participating physician irrespective of the patient enrollment decision. Each patient will be followed-up in routine care setting for 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form.
* Patient with moderate to severe AD according to the Investigator's judgment and

  1. Patient eligible to systemic treatment as Atopic Dermatitis Control Tool (ADCT) more than or equal to (≥) 7 and/or use topical corticosteroids (TCS) more than (\>) 90 gram (g)/month and/or TCS are not advisable.

     or
  2. Patient currently under systemic treatment.
* Able to understand and complete study-related questionnaires.

Exclusion Criteria:

* Any condition that, in the opinion of the Investigator, may interfere with patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities that can predictably prevent the patient from adequately completing, as per routine care, the schedule of visits and assessments
* Patient receiving systemic therapy only for a disease other than AD.
* Patient participating in any interventional clinical trial at the time of enrolment.
* Patient is under tutorship or curatorship; patient under safeguard of justice or deprived of his/her liberty by an administrative or court decision
A Multi-Center, Open-label Study Evaluate the Efficacy and Tolerability of a Dual Skincare Regimen Treatment for Facial Hyperpigmentation and Photodamaged Skin in Patients Exposed to Extrinsic Factors of Aging

This open-label, multi-center clinical trial was conducted to evaluate the dual skincare regimen of vitamin C serum and moisturizing sunscreen SPF 45 to improve facial hyperpigmentation and photodamage after 12 weeks of twice daily use in healthy female subjects between 35 - 60 years old. A total of 33 subjects completed study participation.

This open-label, multi-center clinical trial was conducted to evaluate the dual skincare regimen of vitamin C serum and moisturizing sunscreen SPF 45 to improve facial hyperpigmentation and photodamage when used twice daily over the course of 12 weeks by healthy women with Fitzpatrick skin type I - V, moderate to severe global face hyperpigmentation and moderate global face photodamage.

Efficacy and tolerability will be assessed through clinical grading at baseline, weeks 4, 8 and 12. Efficacy evaluation for hyperpigmentation (mottled), hyperpigmentation (discrete), overall photodamage, clarity/brightness, overall appearance, skin tone evenness (redness), fine lines and wrinkles. Investigator and subject tolerability, self-assessment questionnaire and clinical VISIA photography will be completed at baseline, weeks 4, 8 and 12. Subject testimonials will be completed at week 12.

A total of 33 subjects completed study participation.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 35 and 60 years old.
* Women with Fitzpatrick skin type I-V.
* Subjects must have moderate to severe global face hyperpigmentation.
* Subjects must have moderate global face photodamage.
* Subjects must have no known medical conditions that, in the investigator's opinion, may interfere with study participation.
* Subjects must be willing to provide verbal understanding and written informed consent.

Exclusion Criteria:

* Subjects which had a health condition and/or pre-existent dormant dermatological disease on the face.
* Subjects that are unwilling to comply with the protocol.
* Female subjects who are pregnant, breast feeding, or planning a pregnancy.
* Subjects who have demonstrated a previous hypersensitivity reaction to any of the ingredients of the study products.
* Subjects who have a history of skin cancer.
* Subjects who have observable suntan, sunburn, scars, nevi, tattoo, excess hair, etc. or other dermatological condition on the face that might influence the test results in the opinion of the investigator.
* Subjects who have routinely used any anti-aging, anti-wrinkles, antioxidants treatments and skin-firming products less than 30 days prior to the study entry.
Community Opioid Innovation Network (JCOIN): TCU Clinical Research Center

There are two study periods for the TCU JCOIN project. The primary aims of Study 1 (approved by the TCU IRB) are (1) to gather information from staff on the current treatment referral process within participating communities and (2) to learn about the existing interrelationships between medical and community behavioral health (CBH) providers. TCU IRB granted approval for Phase 1 on 11/07/19, approval number: 1920-60-AM1. Study 2 (under current review by the TCU IRB) includes recruitment across 18 community collaboration sites across 3 states; these communities will participate in the TCU Opioid-Treatment Linkage Model (O-TLM) protocol. The O-TLM is focused on best practices for improving screening, identifying and linking to MOUD providers, reducing stigma, and addressing other important factors that impact justice-involved individuals returning to their communities. Along with their agency records, information collected from justice-involved individuals within the target communities will be examined to assess O-TLM impact on improving public health and public safety outcomes. Furthermore, stakeholder staff across community organizations, including criminal justice and treatment agencies, will be asked to complete surveys on the O-TLM regarding its acceptability and adoption, as well as on best training strategies.


Eligibility Criteria:
Inclusion Criteria:

* client level participant eligibility includes having a history of opioid use or at risk for opioid use; being released to a participating community while under supervision
* staff level participant eligibility includes being a key member of a participating community and involved in the service assessment and referral process of justice-involved individuals.

Exclusion Criteria:

* no history of opioid use or being at risk of opioid use; not being released to a participating community.
* staff level participant exclusion criteria include not being a key member of a participating community and not being involved in the service assessment and referral process of justice-involved individuals.
Effects of High Protein Diet on Muscle Mass, Strength, and Physical Performance in Postmenopausal Women

Despite the importance of preventing muscle mass loss during senescence, only a few studies have investigated the relationship between diet and muscle mass in postmenopausal women. Therefore, the aim of this study is to investigate whether controlled protein consumption at the current Recommended Daily Allowance (RDA = 0.8 g/kg body weight) or twice the RDA (1.6 g/kg body weight) affects skeletal muscle mass, strength, and physical performance in postmenopausal women. In this parallel-group trial, participants were randomized for 6 months to low glycemic index diets with controlled protein consumption at the current RDA or twice the RDA, aimed to balance energy needs.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women
* Without mobility aids, able to perform activities of daily living independently

Exclusion Criteria:

* Use of hormone therapy in the past 3 months
* Insulin therapy
* Previous diagnosis of heart disease
* Untreated thyroid diseases
* Conditions affecting neuromuscular function