cyrilzakka/clinical-trials huggingface dataset:
Oral Care Study on Burn Patients

There have been multiple articles done regarding oral hygiene on patients in burn and intensive care patients. All articles agree the need for good oral hygiene in these special needs patients. They also note that more research needs to be done on this subject, yet have no direction of how to proceed in this research. Currently, no research has been done on the burn/intensive care patient to see if there is a difference form the non-hospitalized patient which oral hygiene protocol is based on.

BACKGROUND IMFORATION AND INTRODUCTION There have been multiple articles done regarding oral hygiene on patients in burn and intensive care patients. All articles agree the need for good oral hygiene in these special needs patients. They also note that more research needs to be done on this subject, yet have no direction of how to proceed in this research. Currently, no research has been done on the burn/intensive care patient to see if there is a difference form the non-hospitalized patient which oral hygiene protocol is based on.

OJECTIVE The primary purpose of this prospective study is to determine if the burn/intensive care patient's oral condition is similar or different from the normal standard.

PATIENT SELECTION CRITERIA

1. Patients age must be 19 and older.
2. Patients must be on a ventilator in the burn or intensive care unit.
3. The control group will be 19 years or older and be randomly picked from from volunteer staff at Saint Elizabeth Regional Medical Center.

DESIGN This is a prospective study that will look at the similarities and difference of both groups. This will help us determine if there is a need to improve oral hygiene protocol given to burn/intensive care patients. Each group will consist of 25 subjects

Eligibility Criteria:
Inclusion Criteria:PATIENT SELECTION CRITERIA

1. Patients age must be 19 and older.
2. Patients must be on a ventilator in the burn or intensive care unit.
3. The control group of Healthy Volunteers will be 19 years or older and be randomly picked from volunteer staff at Saint Elizabeth Regional Medical Center.

Exclusion Criteria:

* Unable to complete Informed Consent Process
Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder

To evaluate the efficacy and safety of quetiapine fumarate sustained release (Seroquel SR) in the treatment of Major Depressive Disorder.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 to 65 years
* A documented diagnosis of major depressive disorder

Exclusion Criteria:

* Patients with a DSM IV Axis I disorder other than MDD within 6 months of enrolment
* Patients with a diagnosis of DSM IV Axis II disorder which has a major impact on the patient's current psychiatric status
* Patients whose current episode of depression exceeds 12 months or is less than 4 weeks prior to enrolment
Safety and Performance Evaluation of the Epitomee Device for Enhancing Satiety and Weight Loss.

Study design to demonstrate the safety and performance of the Epitomee Device

Prospective, single center, open-labeled single arm study. The subjects will be enrolled in one investigational site. Subjects meeting eligibility criteria will receive multiple capsule intakes, 1 capsule twice daily for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. 21 ≤ Age \<65 years
2. 28 \< BMI ≤ 40 kg/m2
3. Healthy subject
4. Normal blood count and chemistry
5. Subject is able and willing to give informed consent
6. Subject is able and willing to participate in the study and follow protocol procedures

Exclusion Criteria:

A. General health and medication

1. Any history or evidence of significant cardiac, renal, neurologic, pulmonary, gastrointestinal, hematologic abnormality, chronic hepatic disease or any other disease or symptom which in the judgment of the investigator would interfere with the study or confound the results
2. Symptomatic or unbalanced metabolic syndrome, or, symptomatic or unbalanced type 2 diabetes - such patients with minor symptoms may be allowed according to the PI discretion
3. Intake of chronic medication which may affect the GI or interrupt with the treatment, unless approved by the PI discretion
4. Taking thyroid hormone deficiency drugs (such as L-thyroxine)
5. Hemoglobin level under 11 gm/dl

   B. Weight loss history and status
6. Currently using pharmaceutical agents or food supplements for weight loss
7. History of weight reduction of more than 5% of total body weight in the past 6 months
8. Eating disorder such as anorexia, bulimia compulsory overeating or emotional eating\*

   C. Specific GI history and status
9. History or evidence of any active liver disease. (abnormal liver functions: \>1.5 times upper limit)
10. Subject with Inflammatory Bowel Disease (IBD)
11. Significant swallowing disorders
12. Less than 3 natural bowel movements per week
13. Past history of any gastrointestinal surgery (excluding uncomplicated appendectomy)
14. Malabsorption disorders

    D. General
15. History of food allergy according to PI decision
16. Female subjects who are breastfeeding or have a positive pregnancy test at screening or at any time during the study
17. History of alcohol or drug abuse within 6 months of screening
18. Mental disorders
19. Currently participating in an ongoing clinical study
Genetic of SportS Induced Endofibrotic Remodeling

search for a genetic cause of vascular endofibrose

Perform a DNA analysis to mark the existence of mutations in one or more genes encoding proteins involved in vascular remodeling high.

5 patients or relatives of patients topics

Eligibility Criteria:
Inclusion Criteria:

* High level reached Cyclists vascular endofibrose
* Cyclist high level and not sick with a brother or sister is senior cyclist reaches the vascular endofibrose.

Exclusion Criteria:

* not obtaining consent
Effects of COVID 19 Vaccine on Egyptian Population

The aim of this study is to identify adverse events following vaccination by the COVID-19 vaccine by evaluating adverse side effects, hematological values; immunogenicity in the Egyptian candidates in response to COVID-19 vaccine, summarizing the which may occur following administration of COVID-19 vaccine.

Coronavirus disease 2019 (COVID-19) is an emerging respiratory infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) that had infected more than 100 million individuals and caused more than 2 million deaths worldwide by February 13, 2021. A safe and effective vaccination trials against COVID-19 is urgently needed. There are currently more than 160 COVID-19 candidate vaccines in development worldwide, and 25 are in different phases of clinical trials using different platforms.

The efficacy and immunogenicity of vaccines varies depending on the study cohort. Race and ethnicity were shown to affect the antibody responses to the rubella vaccine, which elicited significantly higher titers in children of African ethnicity compared to those of European descent or Hispanic ethnicity, likely, disparities in serologic responses to vaccines were also observed between different ethnic groups for the Haemophilus influenzae type b-tetanus toxoid conjugate vaccine , or the Haemophilus influenzae type b polysaccharide-Neisseria meningitidis outer membrane protein conjugate vaccine . thus keeping the race an important factor in studding its effect on immunogenicity of vaccine. Thus keeping the race an important factor in studding its effect on immunogenicity of vaccine, which pushed us to estimate immunogenicity in Egyptian population after vaccination with the inactivated COVID-19 vaccine.

Heamatological changes after vaccination had been detected in many researches; lecuocytosis was found shortly after vaccination of infants, which was primarily a neutrophilia but no participant received antibiotics and all remained well at follow-up . In a case series study, also leukocytosis with fever was detected following pneumococcal vaccine administration . On the other hand, neutropenia was detected following a new vaccine against Shigella sonnei . Platelets abnormalities also had been detected following vaccination, a previous example is idiopathic thrombocytopenic purpura, linked to the administration of measles-containing vaccines .

Eligibility Criteria:
Inclusion Criteria:

1. People aged 18-80 years.
2. Negative for serum-specific IgM/IgG antibodies against SARS-CoV-2, as measured by a commercial kit (Innovita, China) at the time of screening.

Exclusion Criteria:

1. A history of infection with SARS-CoV 3 months before the vaccine.
2. Fever, cough, runny nose, sore throat, diarrhoea, dyspnoea, or tachypnoea in the 14 days before vaccination.
3. Pregnancy.
4. A history of seizures or mental illness.
5. Being on immunosuppressive agents.
6. Being on anticoagulation therapy.
7. Being unable to comply with the study schedule.
Impact of Modifications to the Rendering of the Antibiogram on the Prescriptions of Meropenem in Pseudomonas Bacteremia

Modification of the rendering of the antibiogram at the Strasbourg University Hospital in November 2019 with the appearance of the concept of "standard dose" or "high dose" sensitivity.

This modification seems to have favored an inappropriate overprescription of Meropenem (the only antibiotic made "at standard dose") in Pseudomonas infections sensitive to other beta-lactams.

In June 2021, it was therefore decided to mask sensitivity to carbapenems by default in the rendering of Pseudomonas antibiograms when the strain was sensitive to a narrower spectrum beta-lactam ("restricted" antibiogram).

The aim of this study is to evaluate the impact of these changes in the antibiogram on antibiotic prescriptions.


Eligibility Criteria:
Inclusion Criteria:

* Major subject (≥18 years old)
* Subject with a positive blood culture result for Pseudomonas spp identified in the microbiology laboratory of Strasbourg University Hospital during the period from June 1, 2018 to November 30, 2022
* Subject not opposing the reuse of their data for the purposes of this research.

Exclusion Criteria:

* Subject having expressed opposition to participating in the study,
* Pseudomonas spp strain resistant to all first-line beta-lactams (Piperacillin-Tazobactam, Ceftazidime, Céfepime and Aztreonam).
* Pseudomonas spp strain resistant to Meropenem.
* Lack of information on the antibiotic treatment undertaken.
The Longitudinal Study of Stimulant Use Disorder

This research is a 5-year observational, longitudinal registry study with no treatment or medication provided as part of participation. Individuals with current or lifetime stimulant use disorder, in addition to healthy control individuals, may be eligible to participate in this study. A variety of assessments and tasks including Magnetic Resonance Imaging (MRI), Electroencephalography (EEG), blood draws, urine drug screens, and both self-report and clinician-rated assessments will be used to assess biomarkers in this population. This study has a visit schedule of four in-person visits and eight remote visits per year.

This project is a five-year observational study that will use a variety of assessments and tasks to phenotype participants with lifetime or current Stimulant Use Disorder as well as healthy control individuals. The data collection will include collecting urine samples for diagnostic tracking, socio-demographic and lifestyle factors, clinical and behavioral assessments, blood-based biomarkers, genomics, cell-based assays, EEG, and MRI to establish phenotypic biosignature subtypes over the longitudinal timeline.

Eligibility Criteria:
Inclusion Criteria:

1. Be an adult between the ages of 18-85, inclusive.
2. Be able to sufficiently understand, speak, and read English to provide informed consent and ask relevant questions.
3. For participants with current/history of Stimulant Use Disorder: Subjects must meet MINI International Neuropsychiatric Inventory (MINI) criteria for current stimulant use disorder or meet MINI supplemental criterial for lifetime stimulant use disorder. For Healthy control individuals: Subjects must meet criteria for a healthy control: No history of substance use disorder or other mental illness as defined by the MINI International Neuropsychiatric Inventory (MINI).
4. Be willing to provide consent and comply with all procedure instructions.
5. Be willing to provide blood samples and participate in EEGs and MRIs.

Exclusion Criteria:

1. For participants with stimulus use disorder cohort: Have a history of schizophrenia, schizoaffective disorders, or chronic psychotic disorders based on the MINI. For healthy control individuals: Have a history of substance use disorder or any other psychiatric disorder as defined by the MINI and supplemental questions.
2. Have any condition for which study participation would not be in their best interest (e.g., cognitive impairment, unstable general medical condition, intoxication, active psychosis) or that could prevent, limit, or confound the protocol-specified assessments, in the opinion of the investigator or their designee.
3. Require immediate hospitalization for psychiatric disorder or suicidal risk as assessed by a licensed study clinician.
IVM With Low Cost Priming, Enhanced Oocyte Recovery, and Delayed Transfer

A protocol was developed to improve pregnancy results after IVM compared to results from studies in the literature. Differences from most published protocols include the use of the Steiner-Tan needle to optimize oocyte environment during oocyte retrieval, use of oral medications and very low doses of FSH, and delayed embryo transfer during subsequent warmed cryo-preserved embryo transfer. Eligible patient have a PCO pattern in their ovaries during transvaginal ultrasound.

All participants are candidates for IVF having PCOS or having PCO patterns in their ovaries who wish to undertake IVM for the potential advantages that it holds. All cycles are proceeded by oral contraceptive use for cycle scheduling purposes. Priming is done with oral letrozole with the addition of 25-75 IU daily starting after 2 days of letrozole. HCG is given when several follicle have diameters 8 mm or greater and no follicles have diameters greater than 13 mm. Oocyte retrieval is done approximately 38 hours later. A Steiner-Tan needle is used for oocyte retrieval in a manner that minimizes the amount of time that an oocyte is out of the ovary and not in a controlled laboratory environment. Oocytes are assessed for maturity for up to 48 hours post retrieval. If mature, oocytes are injected with sperm using ICSI. Embryos are grown to blastocysts and all blastocyst are vitrified. Warmed cryo-preserved blastocyst are transferred using routine IVF protocols during a subsequent cycle.

Eligibility Criteria:
Inclusion Criteria:

* PCO pattern with \> 25 antral follicles
* AMH \> 3.5

Exclusion Criteria:

* BMI \> 35
* body morphology making transvaginal retrieval difficult or impossible
* complicating medical condition making pregnancy or IVF relatively contra-indicated
Insulin Glulisine, Diabetes Mellitus Type 1

To provide local data on efficacy and safety of insulin glulisine in patients with Type 1 Diabetes Mellitus receiving insulin glargine as basic insulin therapy


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus, Type 1
* HbA1c 6.5-11.0%
* BMI \<35 kg/m²

Exclusion Criteria:

* Diabetes mellitus, Type 2

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Multicenter Study to Compare Multiple Doses of Intravitreal Microplasmin Versus Sham Injection for Treatment of Patients With Diabetic Macular Edema (DME)

A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with DME.


Eligibility Criteria:
Inclusion Criteria include:

* patients \>18 years of age with Diabetic Macular Edema

Exclusion Criteria include:

* PVD present at baseline
* Vitreous hemorrhage
* Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR)
* Patients who have had a vitrectomy in the study eye at any time
A Clinical Trial to Prevent the Complications of Insulin Resistance (Including Type-2 Diabetes)

The goal of this study is to aggressively treat insulin resistance and its clinical manifestations when they first appear in childhood, and to prevent the subsequent progression towards impaired glucose tolerance and type-2 diabetes. In the process of this clinical trial, we will learn more about the early manifestations of insulin resistance, its treatment, and its relationship to obesity and type-2 diabetes through parallel in-vivo and in-vitro studies.


Eligibility Criteria:
Inclusion criteria:

1. Obese patients (wt \> 95th percentile for age, for adults increased BMI \> 27) greater than 5 years of age
2. And/or presence of complications of insulin resistance such as acanthosis nigricans, dyslipidemia, elevated blood pressure, hyperandrogenism
3. Siblings and parents of patients with insulin resistance. Siblings and parents will be included only in the case of documented insulin resistance in the index subject. Insulin resistance will be documented by OGTT and/or IVGTT.
4. Family history of type II diabetes.

Exclusion Criteria:

1. Critically ill patients, patients will congestive heart failure, renal or liver insufficiency
2. Inability to give consent.
3. History of poor compliance with physician's recommendations
Impact of Active Video Game on Cardiorespiratory, Macro and Microcirculation Function of Adolescents With Overweight

This study evaluates the effects of physical exercise through active videogame in the microcirculation, macrocirculation, cardiorespiratory function and physical fitness in overweight adolescents. For that, they will be randomized into two groups, one being a control group and the other intervention group. The randomization will be made by school. The intervention group will perform the physical exercise through the active video game, three times a week, for 50 minutes, during 8 weeks. Reassessments will be performed before and after the intervention to evaluate the outcome variables.


Eligibility Criteria:
Inclusion Criteria:

* Overweight or obese adolescent
* Students enrolled in public schools

Exclusion Criteria:

* Motor, cognitive or pulmonary limitation
* Genetic syndrome
* Pregnancy
* Use of medication that changes the lipid or glucose profile
* Not being treated for overweight
HighCycle: Effect of Acetazolamide on Pulmonary Artery Pressure in Women Compared to Men

Randomized clinical trial evaluating the effect of acetazolamide on pulmonary artery pressure in women compared to men travelling to 3600 m.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking men and women, age 18-44 years, without any diseases and need of regular medication (including oral contraceptives).
* BMI \>18 kg/m2 and \<30 kg/m2
* Born, raised and currently living at altitudes \<1000 m
* Written informed consent
* Premenopausal women with an eumenorrheic cycle

Exclusion Criteria:

* Other types of contraceptvies (hormonal intrauterine device, vaginal ring, subcutaneous injections or implants, among others)
* Pregnancy or nursing
* Anaemic (haemoglobin concentration \<10g/dl)
* Any altitude trip \<4 weks before the study
* Allergy to acetazolamide and other sulfonamides
Experiences and Perceived Needs Among Parents of Children Exposed to Potentially Traumatic Events: a Qualitative Inquiry

This study aims at exploring qualitatively experiences and perceived needs among parents of children exposed to potentially traumatic events, including their attitudes and understanding of trauma and resilience, their perceptions of their parental role in the peri-traumatic period, and their expectations of a family intervention for post-traumatic stress. This will ultimately guide future research to develop and design and intervention that would be tailored to their needs and expectations


Eligibility Criteria:
Inclusion criteria:

* Being a parent of a child aged 7-17
* exposed or who recently revealed a potentially traumatic event in the past six months

Exclusion criteria: Abusive parent Child and/or parent with intellectual deficiency
the Effect of Dexmedetomidine and Licodaine on Acute Postoperative Pain in Gynecological Laparoscopy

The aim of this study is to investigate the effect of opioid-free anesthesia using dexmedetomidine and lidocaine instead of remifentanil infusion, on the acute postoperative pain after the gynecological laparoscopy

This study is performed to investigate the effect of dexmedetomidine and lidocaine the postopeative pain, shivering, nausea and vomiting after the gynecological laparoscopy.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for elective gynecological laparoscopy

Exclusion Criteria:

* emergent surgery
* cancer surgery
* chronic pain requiring pain killers
* psychiatric disease
* preoperative bradycardia (HR \< 50 bpm)
* allergies
* pregnancy or breast feeding
The Associations Between Sedentary Behaviour and Impact Characteristics on Bone Health

To investigate associations between sedentary and active behaviour with bone health and functional ability, and to associate mechanical loading at the lumbar spine and hip in sedentary and active individuals with bone mineral density.

Significant proportions of adults engage in sedentary behaviour for prolonged periods of time which is generally regarded as having deleterious effects on health. However, far less is known about its specific effects on bone health. Exercise has been proposed as a method of improving bone health, as impact forces generated as the foot contacts the ground during physical activity have the potential to aid bone maintenance and development.

The properties of bone are regulated through the amount mechanical loading, frequency of loading and duration of loading endured, which can create an osteogenic effect. These variables can be quantified via accelerometry which records the magnitude, rate and duration of accelerations experienced at the site on the body where the accelerometer is worn. Although there is a vast amount of literature where accelerometers have been used to monitor physical activity, there is a lack of studies that use accelerometers to determine the most effective exercise for bone, especially in relation to the lumbar spine. Exploring the bone health and loading characteristics of sedentary and low and highly active non-sedentary individuals will provide evidence upon which to base future interventions that are likely to be of benefit for bone health in sedentary populations.

Eligibility Criteria:
Inclusion Criteria:

Male or female aged 30 - 60 years Individuals who are sedentary and do not participate in physical activities Individuals who participate in some physical activities Individuals who are highly active Must be free from injury or illness that will affects following typical weekly routines.

Exclusion Criteria:

Any medical condition that affects bone health, e.g. osteoporosis. Currently takes medication that affects bone health, e.g. long term steroid use.

Inability to participate in typical daily activity, e.g. severe arthritis, injury. Women who are post menopause Women who are on hormone replacement therapy Unable to participate in DXA scan, e.g. due to recent exposure to radiation, pregnancy status.
Safety and Effectiveness of Nivolumab in Recurring Kidney Cancer Participants

A non-interventional, medical record review of clinical data collected from Japanese participants with recurring kidney cancer


Eligibility Criteria:
Inclusion Criteria:

* A patient with RCC with distant metastasis treated for the first time with nivolumab

Exclusion Criteria:

* Patients who have participated in some trials with immuno-checkpoint blockade before or after treatment with nivolumab after diagnosis with RCC

Other protocol defined inclusion/exclusion criteria could apply