cyrilzakka/clinical-trials huggingface dataset:
White Blood Cell SPECT/CT and Diabetic Foot Osteomyelitis

Osteomyelitis is a risk factor for lower extremity amputation in diabetic people. Antibiotic therapy allows a remission in 60 to 80% of cases. However the optimal duration of antibiotic therapy remains controversy due to the absence of validated marker of osteomyelitis remission. We have previously shown that the negativity of white blood cell SPECT/CT (Single Photon Emission Computed Tomography/Computed Tomography) imaging at the end of treatment allowed to predict remission of osteomyelitis at 1 year in all cases. A positive imaging was associated with recurrence in 70% of cases. The aim of our study was to evaluate prospectively the interest of white blood cell SPECT/CT to set the duration of antibiotic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Diabetes
* Osteomyelitis defined by soft tissue infection and/or positive probe-to-bone test and suggestive signs of osteomyelitis on plain-X-Ray

Exclusion Criteria:

- Indication for acute surgical bone resection or amputation
The Influence of Perioperative Administration of Dexmedetomidine on Inflammation Response and Postoperative Outcomes in Patients Undergoing Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Cytoreductive Surgery; Double Blind Randomized Controlled Trial

Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) has been reported to be an effective treatment approach for peritoneal cancer, however, the stress response to HIPEC is major neuroendocrine and cytokine response, which has been considered as the homeostatic defense mechanism. Recently, dexmedetomidine has been suggested to exhibit anti-inflammatory properties. This study was designed to evaluate the effect of perioperative administration of dexmedetomidine on inflammation response and postoperative outcomes in patients undergoing hyperthermic intraperitoneal chemotherapy (HIPEC) cytoreductive surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients between 20 and 70 years old
* obtaining written informed consent from the patients who were undergoing hyperthermic intraperitoneal chemotherapy (HIPEC) cytoreductive surgery
* weights under 90 kg and BMI under 32

Exclusion Criteria:

* emergency operation
* re-operations
* combined surgery over 4 departments.
* cardiac disease (unstable angina, congestive heart failure, valvular heart disease)
* Ventricular conduction abnormality
* prior pacemaker insertion
* uncontrolled hypertension (diastolic blood pressure \> 110mmHg)
* bradycardia (HR \< 40 Bpm)
* cerebral vascular disease (cerebral hemorrhage, cerebral ischemia)
* hepatic or renal failure
* patients who take antiarrythmic agent
* neurological or psychiatric illnesses
* foreigner and patient who can not read the letter
A Study of HS135 for the Treatment of Pulmonary Arterial Hypertension in Adults

A Study of HS135 for the Treatment of Pulmonary Arterial Hypertension in Adults

Phase 1b, Multicenter, Open-Label, Multiple Ascending Dose Study Assessing the Pharmacokinetics, Safety, Pharmacodynamics, and Efficacy of HS135 Added to Background Pulmonary Arterial Hypertension (PAH) Therapy

Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients, 18 years of age and older.
2. Body Mass Index (BMI) 18.5 and 40 kg/m2 and body weight at or below 120 kg
3. Documented diagnostic RHC at any time prior to screening.
4. Diagnosis of WHO PAH Group 1.
5. Symptomatic PAH classified as WHO FC II to IV.
6. Baseline RHC performed during the Screening Period documenting a minimum PVR of ≥ 5 Wood units (WU) or ≥ 400 dyn・sec・cm-5 and a pulmonary artery wedge pressure (PAWP) of ≤ 15 mmHg.
7. On stable doses of at least 2 background PAH therapies.

Exclusion Criteria:

1. Left ventricular ejection fraction \< 50% at screening.
2. Any symptomatic coronary disease events within 6 months of the screening visit.
3. Uncontrolled systemic hypertension.
4. History of restrictive, constrictive or congestive cardiomyopathy.
5. History of atrial septostomy.
6. Patients who have an abnormality in the Echocardiogram or in the 12-lead ECG that, in the opinion of the Investigator, increases the risk of participating in the study.
7. Pulmonary function test (PFT) values of forced vital capacity (FVC) and or FEV1 \< 60% predicted at the screening visit or within 6 months prior to the screening visit.
A Study to Assess the Rate of Hospitalization in Participants With Schizophrenia Treated With Antipsychotics

The primary purpose of the study is to compare the rate of hospitalization associated with psychotic relapse in participants with schizophrenia treated one year before with oral antipsychotics and one year after with long acting injectable atypical antipsychotics.

This is a retrospective (take a look back at events that already have taken place), observational, multicenter (when more than one hospital or medical school team work on a medical research study) study to review medical records of adults with a diagnosis of Schizophrenia during the time period from 01 January 2009 through 31-December-2013 (only for Mexican population). Data will be collected from clinical practice. The medical records of participants will be screened and eligible participants data will be collected. The period of observation will span from 12 months before initial Long Acting Injectable (LAI) use and in 12 months after the initial LAIs use. The rate of hospitalization will be primarily evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Out-Patients with the main diagnosis of schizophrenia with Diagnostic and Statistical Manual of Mental Disorders (DSM-4 criteria)
* Only clinical records with complete information during the 2 years period selected for data analysis will be included
* Participants treated with oral antipsychotics then switched to Long Acting Injectable (LAI) due to poor adherence, lack of efficacy (no significant symptom reduction, judged by physician, at maximum recommended dose of an antipsychotic for 6 weeks), or participants choice, (Excluding for the Brazil population, when the switch has not been clearly justified or the switch has not been done during hospitalization)
* Being regularly treated with LAI atypical antipsychotics for at least 1 year after the initial use of LAI atypical antipsychotics

Exclusion Criteria:

* Participants with refractory schizophrenia (RS)
* Participants that started LAI treatment as in-patients and patients that switched to LAI during hospitalization (only for Mexican population).
Growth Hormone, Cardiovascular Risk, and Visceral Adiposity

This study will compare growth hormone levels and cardiovascular risk markers in normal weight and overweight women and men. In women and men with increased abdominal weight, growth hormone (GH) versus placebo will be administered and effects on cardiovascular risk, insulin resistance and body composition will be measured.

The purpose of this study is to measure growth hormone levels in women and men who are normal weight, overweight, and obese. Growth hormone levels will be correlated with body weight, body composition, and markers of cardiovascular risk. In overweight or obese women and men with increased visceral adiposity and below average IGF-1 levels, growth hormone versus placebo will be given for 6 months. Effects of growth hormone treatment on weight, body composition, insulin resistance, lipids, and cardiovascular risk markers will then be assessed. Study subjects will be followed for an additional six months for these endpoints.

Eligibility Criteria:
Inclusion Criteria:

* For growth hormone measurement part (for men and women):

  1. For visceral adiposity arm: waist circumference greater than or equal to 88 cm for women or 102 cm for men, and BMI greater than or equal to 25 kg/m2
  2. For lean controls: BMI 18.5 to 24.9 kg/m2
* For growth hormone treatment part (for men and women):

  1. Visceral adiposity (waist circumference greater than or equal to 88 cm for women and 102 for men, BMI greater than or equal to 25 kg/m2)
  2. IGF-I within the lowest 2 quartiles for age and gender
  3. Willingness to maintain current activity level and diet

Exclusion Criteria:

* Diabetes mellitus (fasting plasma glucose greater than 126 mg/dL or 2-hour post-oral glucose tolerance test \[OGTT\] plasma glucose greater than 200)
* Taking the following medications in the last 3 months: weight loss or lipid-lowering agents, medications to treat diabetes mellitus or "pre-diabetes", oral contraceptives or estrogen-containing medications, other medications known to significantly affect weight
* Smoking
* Hematocrit below the lower limit of normal
* Amenorrhea for 3 months (in women)
* Pregnant or breastfeeding (in women)
* Polycystic ovary syndrome (in women)
* Weight that exceeds 280 pounds
* SGPT greater than 2 times the upper limit of normal
* History of malignancy, except for fully resolved basal cell carcinomas of the skin (Specific Aim 2 only)
* Radiation exposure greater than 1000 mrem over the last 12 months
* Previous diagnosis of cardiovascular disease
* History of pituitary or hypothalamic disease, brain radiation, or childhood growth hormone deficiency
* History of carpal tunnel syndrome that has not been surgically treated
Naltrexone and Memantine Effects on Alcohol Drinking Behaviors

The purpose of this study is to evaluate the combined effects of the study medications naltrexone and memantine on alcohol drinking behaviors.

Participants will be randomized to receive a combination of naltrexone/memantine over a one week period and then participate in a laboratory session. During this session, participants are given an initial drink of alcohol followed by the choice to drink up to 12 more drinks over a three-hour period. These medications are hypothesized to reduce craving and number of drinks consumed prior to and after exposure to the initial drink of alcohol and during the three hour drinking period.

Eligibility Criteria:
Inclusion Criteria:

* Ages 21-55
* Able to read English at 6th grade level or higher and to complete study evaluations
* Regular alcohol drinker

Exclusion Criteria:

* Individuals who are seeking alcohol treatment
* Medical conditions that would contraindicate the use of study medication
* Regular use of other substances
Study of Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer

This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer.

This study will examine a sequence of treatments including pre-operative chemotherapy and radiation, surgery and post-operative chemotherapy for resectable pancreatic cancer. This research treatment will evaluate the combination of two chemotherapy agents, oxaliplatin and gemcitabine with radiation therapy. The researchers have already done studies using oxaliplatin, gemcitabine and radiation therapy together for pancreatic cancer. They want to build on the information they have from this previous research and do the research at multiple sites. They will use this study to determine how well people do who are treated with gemcitabine, oxaliplatin, and radiation therapy prior to having surgery for their pancreatic cancer. The researchers will also gather more information about what type of side effects occur with this treatment.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have cytologic or histologic confirmation of carcinoma arising in the pancreas.
* Patients must be deemed resectable or borderline resectable based on criteria in section 4.2 prior to registration.
* Patients must have an expected life expectancy of at least 12 weeks and a Zubrod performance status of \< 2.
* Patients must have adequate organ function defined as follows: absolute neutrophil count of \> 1500/mm3, platelets \> 100,000/mm3, serum Cr \< 1.5 mg/dl, total bilirubin \< 3.0 mg/dl with relief of biliary obstruction if present (PTC tube or endobiliary stent).
* Patients must be free of other active systemic malignancy, ongoing infection, including HIV infection, or any other serious uncontrolled, concomitant systemic disorders or psychiatric condition that would interfere with the safe delivery of protocol therapy.
* Patients must be aware of the investigational nature of the therapy and provide written informed consent.
* Patients must have no history of previous chemotherapy for pancreatic cancer or any abdominal radiation therapy.
* Patients must not have used any investigational agent in the month before enrollment into the study.

Exclusion Criteria:

* Patients with neuroendocrine tumors are excluded.
* Patients with preexisting peripheral neuropathy \> grade 2 are ineligible.
* Pregnant or nursing women are ineligible and patients of reproductive potential must agree to use an effective contraceptive method during participation in this trial and for 6 months after trial.
Continuous Positive Airway Pressure for the Treatment of Stroke

New stroke therapies are needed. This study seeks to provide the preliminary data needed to plan a future study that will evaluate the efficacy of using continuous positive airway pressure (CPAP) to treat stroke patients who have sleep apnea. Our goal is to use this therapy to reduce stroke symptom severity.

BACKGROUND Sleep apnea occurs in 60-96% of stroke survivors and is associated with poor functional recovery and higher post-stroke mortality. Among patients without stroke, continuous positive airway pressure (CPAP) is a safe and effective treatment for sleep apnea. This feasibility pilot study is a step in planning a future efficacy trial of CPAP for patients with acute ischemic stroke.

OBJECTIVES The primary objectives are, among acute ischemic stroke patients, to: (1) determine the feasibility of performing polysomnography; (2) refine the process for providing CPAP within 48-hours of stroke onset; and (3) determine the effect of CPAP on blood pressure.

METHODS This randomized controlled feasibility study will enroll 100 acute ischemic stroke patients. Intervention patients (N=60) receive CPAP within 48 hours of stroke onset and continuing for up to 30 days. At 30 days post-enrollment, the intervention patients undergo unattended polysomnography. Control (N=40) patients receive unattended polysomnography at baseline and after 30 days.

SIGNIFICANCE CPAP represents an important new potential therapy for acute stroke. CPAP may reduce both the neurological symptom severity of the acute stroke and prevent stroke recurrence.

Eligibility Criteria:
Inclusion Criteria: acute ischemic stroke with NIH Stroke Scale \>=2 -

Exclusion Criteria: respiratory distress; COPD requiring oxygen; primary intracranial hemorrhage on admission brain imaging; time from symptom onset to sleep study or CPAP treatment \>72 hours or time from hospital admission to sleep study or CPAP treatment \>48 hours; life expectancy less than 6 months; inability to provide informed consent; inability to communicate in English; residence outside the greater New Haven area; or any condition where the monitoring required by the study would constitute a risk to the patient or impair his or her care.

-
Wei Nasal Jet Tube vs Gastro Laryngeal Tube in Endoscopic Retrograde Cholangiopancreatography

The most common adverse event in endoscopic procedures is hypoxia. Different airway devices have been investigated in the literature to prevent hypoxia. This study aimed to compare the efficacy and procedural performance of two different airway (GLT and WNJ) devices in ERCP procedures.

ERCP is a procedure that requires intolerable positioning, prolonged air insufflation, and deep levels of anesthesia. The procedure can be performed under general anesthesia or with deep sedation. It becomes more difficult to maintain airway patency in the prone position under deep sedation. Clinicians prefer supraglottic airway devices developed for endoscopic procedures. GLT requires a deeper level of anesthesia. WNJ, on the other hand, can be tolerated with less depth levels of anesthesia. It has been reported in the literature that GLT and WNJ are effective in maintaining patent airway and preventing hypoxia in ERCP procedures. However, both airway devices have not been compared for airway efficiency and ERCP procedure condition.

In this study, the investigators aimed to compare airway efficiency and procedure condition using GLT and WNJ.

Eligibility Criteria:
Inclusion Criteria:

* ASA Physical Status 1-2
* Elective Procedures
* Body mass index 18.5 - 35 kg/m2

Exclusion Criteria:

* High risk of pulmonary aspiration
* Pregnancy
* Anesthesic drug allergies
* Difficult airway or facial deformities
* Height \<155 cm
* Alcohol or narcotic drug usage
* Restrictive or obstructive pulmonary diseases
* Hepatic cardiac or renal failure
* Neurologic or cognitive deficiencies.
* Previous cervical surgery or cervical radiotherapy
* Previous esophagus surgery
* Psychotic problems
Weight Variation on Cop

This study will be conducted to investigate the impact of variant weights in adolescents during unperturbed standing conditions.

200 adolescents from both sexes will be assigned to this study. They will be selected randomly from a secondary school student and first level university students. They will be assigned into four group of equal numbers according to (BMI) body mass index for age percentile obese group (n=50), overweight group (n=50), underweight group (n=50) and normal group weight (n=50).The FREEMED platform and FREESTEP software were used to assess the following parameters for each subject:

1. Sway length (mm).
2. The Maximum (peak) Oscillation of COP.
3. The minimum Oscillation of COP.

Eligibility Criteria:
Inclusion criteria:

* Their age will be ranging from 16 to 18 years.
* The sample will be selected according to (BMI-for Age percentile) growth charts according to CDC (Centers for Disease Control and Prevention) (appendix-1) (NCHS, 2014)
* All participant will be free from any musculoskeletal deformities.
* All participant are free of peripheral neuropathic diseases.
* They have no visual or auditory or vestibular disorders.
* They will able to understand, follow and execute instructions included in the testing analysis procedures.

Exclusion criteria:

* All adolescent associated with any musculoskeletal deformities.
* All adolescent associated with any foot deformity.
* All adolescent had a previous foot orthopedic procedure.
* All adolescent has visual or auditory or vestibular disorder.
* All adolescent has peripheral neuropathy.
* Adolescent with morbid obesity BMI \>99th for age percentile (Barlow, 2007).
Study of Clinical and Immune Severity Profiles of Patients Infected With SARS-Cov2 (COVID-19)

The SARS-CoV2 virus causes severe or even fatal disease in a fraction of infected people. The clinical severity is based on a complicated pneumopathy with acute respiratory distress syndrome that can lead to multi-visceral failure. The underlying mechanism is a cytokinergic storm, an emerging facet of immunological dysregulation.

This clinical trial is aimed to understand the mechanisms of this immunological dysregulation in order to identify therapeutic levers.

The main objective is to understand the relationships between clinical severity, death or morbidity of resuscitation management, and immune status (i.e., immune pathways activated or not). Immune status will be investigated at many levels of organization (i.e., circulating leukocytes, cytokines and chemokines, transcripts).

The secondary objectives are :

* to understand what is responsible for clinical severity, viral load, or immune activation;
* to highlight the consequences of immunological dysregulation on associated risks (i.e., immunosuppression leading to the emergence of infectious comorbidities) as well as the functioning of neurotransmission through metabolic pathway diversions. The impact of dysimmunity on these biological pathways will be assessed with a metabolomic analysis;
* to understand the mechanisms of vulnerability related to the field. Moreover, while co-morbidities are likely to be a risk factor for severe disease progression, there are many situations in which they do not occur. Stress, with its neurovegetative and endocrinological dimensions, modulates the immune response. It is essential to know whether the stress response plays a role in immunological dysregulation. This analysis is a prerequisite for understanding the conditions of treatment with glucocorticoids.

Angiotensin converting enzyme type 2 (ACE2) also plays a likely role in host viral infection. It is also thought to play an important role in the emergence of severe syndromes by affecting the quality of vascular response.


Eligibility Criteria:
Inclusion Criteria:

* Patient admitted to intensive care unit with confirmed SARS-CoV2 infection
* Patient older than 18 years old

Exclusion Criteria:

* Patient coming from another intensive care unit after more than 5 days in the intensive care unit
* Known immunosuppression:

  * Known or suspected HIV
  * Known or suspected immunosuppression :
  * Organ transplantation
  * Marrow transplant
  * Congenital deficit
  * Received immunosuppressive therapy within 30 days (azathioprine, methotrexate, tacrolimus, cyclosporine, sirolimus, cyclophosphamide, rituximab, anti-TNF, JAK inhibitors, corticosteroids \>10mg/day over the last 30 days, recent covid-19 corticosteroid therapy \>1mg/kg prednisolone or equivalent \>5 days)
  * Administration of chemotherapy within the last 3 months
* Current pregnancy or breastfeeding
* Patient under 18 years of age
* Incapacitated adults and persons deprived of their liberty
* Refusal by the patient or his/her support person
Study to Evaluate an Aflibercept (EYLEA®) Prefilled Syringe

The primary objective of the study is to determine if the pre-filled syringe (PFS) supports successful preparation and accurate administration of an aflibercept injection.

The secondary objective of the study is to assess ocular safety in the study eye.


Eligibility Criteria:
Key Inclusion Criteria:

* Participants who have neovascular age-related macular degeneration (AMD), diabetic macular edema (DME), retinal vein occlusion (RVO), or diabetic retinopathy (DR) with diabetic macular edema (DME) in the study eye

Key Exclusion Criteria:

* Evidence of active infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye
* Any active intraocular inflammation or infection in either eye or history of intraocular inflammation or infection after past intravitreal injection treatment (IVT) injections with any agent in either eye
* History of or any current indication of excessive bleeding and recurrent hemorrhages, including any prior excessive intraocular (including subconjunctival) bleeding or hemorrhages after IVT injection or intraocular procedures in either eye
* Any intraocular surgery in the study eye at any time during the past 3 months
* Current systemic infectious disease or a therapy for active infectious disease
* Pregnant or breastfeeding women

Note: Other inclusion/ exclusion apply
Evaluation of Covid 19 Anxiety in Endometriosis Patients

It is aimed to measure the general anxiety and lifestyle information of endometriosis patients about covid 19 pandemic, to evaluate anxiety levels in this period.


Eligibility Criteria:
Inclusion Criteria:

* endometriosis patients
* no psychiatric illness
* no antidepressant use

Exclusion Criteria:

* women who had not endometriosis
* no extra health conditions
* women younger than 18 and older than 45