cyrilzakka/clinical-trials huggingface dataset:
German Stroke Registry - Endovascular Treatment

The German Stroke Registry (GSR) Endovascular Treatment is an academic, independent, prospective, multicentre, observational registry study. Consecutive patients treated with endovascular stroke treatment will be enrolled in German stroke centers. Patients receive regular care and data will be collected as part of clinical routine. Baseline clinical and procedural information as well clinical follow-up information during in-hospital stay, and up to 90 days of stroke onset are collected. Data collected include demographics, National Institute of Health Stroke Scale (NIHSS) on admission, pre-treatment ASPECTS, information on timing and success of interventional treatment, procedural complications, intracranial hemorrhage, and functional outcome.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute ischemic stroke
* Eligible for intravenous thrombolysis (IVT) and IVT initiated within 4.5 hours after stroke onset
* Confirmed diagnosis of persistent occlusion of terminal carotid artery, middle cerebral artery (M1 or M2), or basilar artery consistent with symptoms
* Age \>18 years
* Ethic approval in process

Exclusion Criteria: none
Impact of Prehabilitation in Total Knee Replacement

A study comparing the benefits of pre-habilitation exercise to standard care prior to total knee arthroplasy

Recovery post Total Knee Replacement Surgery ((TKA) has been a subject of interest. In a study of 379 patients who had hip or knee replacement surgery, it was reported that at 6 months post-surgery patients with better baseline function had superior functional ability and less pain than patients with lower function at baseline. Another study of 276 patients undergoing TKA reported that pre-operative joint function was a predictor of joint function and overall function at 6 months post-surgery. These findings suggest that prehabilitation to increase functional ability prior to TKA may have a positive effect in recovering post-surgery. In a randomized control trial of patients receiving TKA, the group receiving an Exercise Program (prehabilitation) made significant improvements in performance from baseline to before surgery, and at 1 and 3 months post surgery. For the group that did not receive the Exercise Program pre-surgery, significant improvement did not occur until 3 months post surgery. The overall objective of the proposed single-blinded randomized controlled trial is to demonstrate that a well designed prehabilitation program for patients receiving TKA surgery will significantly improve outcomes related to pain and function and may reduce utilization of health care services post surgery.

In this randomized control trial we hypothesize that the group of participants who receive a prehabilitation Exercise Program will recover quicker than patients who do not receive the Exercise Program based on several measures of performance including pain, quadriceps strength, range of motion and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo unilateral TKA surgery
* Ambulatory
* Community dwelling (living at home)
* Able to participate in moderate intensity exercise
* American Society of Anesthesiologists Physical Status Classification(ASA) 1 - 3
* Speaks English

Exclusion Criteria:

* Patients who are planning a second surgery of the lower limbs during the six months post-surgery
* Have the effect of peripheral vascular disease or stroke on walking
Sensory-motor Interactions in the Perception of Vowels: a Study in Repetition - Suppression

The aim of our study is to show by fMRI the involvement of the motor system in the perception of speech, and more particularly how this implication is modulated by the degree of prototypicity of the stimuli.

Each participant will undergo two visits:

Phase 1: The Gipsa-Lab Laboratory's Department of Speech and Cognition. This first visit will make it possible to make recordings of their vowel productions and to verify that the participants correspond to the criteria necessary for the study (passing the Edinburgh manual laterality test and auditory thresholds checked using a " An audiogram). It will also be an opportunity to provide them with the consent documents and the fact sheet, which will give them time to read it before the MRI exam. The duration of this first visit will be approximately 1 hour.

Phase 2: fMRI review in the 3Tesla MRI Unit at the Grenoble University Hospital Center. Participants will first undergo a medical examination in order to verify their absence of contraindication to the MRI examination. At the end of this medical examination, the consent of participation will be signed. The participants will then be able to carry out the MRI examination for a duration of about 1h15, then the behavioral judgment test of perceptual distance. The total duration of this second visit will be approximately 1h45.

Eligibility Criteria:
Inclusion Criteria:

* Medicall exam before MRI
* Pregnant Women
* Patients aged 18-45 years, Right-handed
* without neurologic and/or psychiatric troubles
* normal audition
* Audition normale
* French mother tongue
* Social security affiliation

Exclusion Criteria:

* protected person
* MRI contraindication
* claustrophobia
* respirtaory and cardiovascular pathology
* toxic substances taking
IL-2 PET Imaging in Advanced Solid Tumours

This is an investigator-initiated, single-center, open-label clinical trial designed to evaluate the safety and PK of the PET tracer \[18F\]AlF-RESCA-IL2 in patients prior to and during treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years at the time of signing informed consent.
2. Patients with histologically confirmed diagnosis of locally advanced or metastatic solid cancer, eligible for ICI therapy as part of routine care.
3. At least 1 lesion that is accessible per investigator's assessment and eligible for biopsy according to standard clinical care procedures.
4. Measurable disease, as defined by standard RECIST v1.1. Previously irradiated lesions should not be counted as target lesions except for lesions that have progressed after radiotherapy.
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Life expectancy ≥ 12 weeks.
7. Signed informed consent.
8. Willingness and ability to comply with all protocol required procedures.
9. For female patients of childbearing potential and male patients with partners of childbearing potential, agreement (by patient and/or partner) to use a highly effective form(s) of contraception (i.e., one that results in a low failure rate (\< 1% per year) when used consistently and correctly)).

Exclusion Criteria:

1. Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to \[18F\]AlF-RESCA-IL2 injection.
2. Evidence of an active infection that requires systemic antibiotics within 2 weeks prior to \[18F\]AlF-RESCA-IL2 injection.
3. Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of \[18F\]AlF-RESCA-IL2, or that may affect the interpretation of the results or render the patient at high risk from complications.
4. Altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
5. Sponsor employee/member of the clinical site study team and/or his or her immediate family
6. Pregnant or lactating females.
7. Concurrent use of systemic corticosteroids \> 10 mg daily prednisone equivalent.
PROM Project Urology

All patients undergoing urological surgery or treatment should receive standardized questionnaires on quality of life, satisfaction, pain and physical recovery. Indication-specific, individual pathways are set up, for example, for patients with localized prostate cancer, benign prostate enlargement, bladder dysfunction or erectile dysfunction. In combination with the clinical data, the PROM data should help to improve the quality of the results and, if necessary, adapt treatment pathways to patient needs.


Eligibility Criteria:
Inclusion Criteria:

1. Patients treated at the Department of Urology
2. ≥18 years of age
3. Active Mail-account, use of smartphone/tablet/PC
4. Written informed consent

Exclusion Criteria:

- Patients who cannot give written consent and/or do not have digital competence (e.g. no active e-mail account)
Cystatin C as an Early Marker of Contrast-Medium Nephropathy in Cardiac Catheterization Patients

Hypothesis:

Cystatin C compared with creatinine is a better and earlier marker of contrast-induced nephropathy in high and intermedium risk cardiac catheterization patients.

Primary Objective:

Establish if Cystatin C is superior detecting contrast-induced nephropathy than creatinine in high and intermedium risk cardiac catheterization patients.

Contrast induced-nephropathy is a complication that is underestimated in clinical practice after cardiac catheterization. During the last 30 years, because of the increasing use of contrast medium for diagnostic and therapeutic procedures, this has become the third in-hospital cause of acute renal failure (12%). That's why, it is necessary to establish an earlier marker of renal dysfunction that can help us in the diagnosis and allow us to initiate the appropriate therapeutics, because depending on the severity of the renal damage, it can increase the cardiovascular risk and morbidity.

The risk of contrast medium nephropathy is still present even with the use of low osmolarity contrast media, and many patients increase their in-hospital days, costs and hemodialysis requirement.

Cystatin C is a non glucosylated protein produced in nucleated cells in a constant rate, and because of its low molecular weight it's filtered through the glomerular membrane without restriction and it's fully reabsorbed in the proximal tubule, that's why it's considered an excellent marker evaluating the glomerular filtration rate in patients with acute renal failure during the first 24-48 hours.

We propose that Cystatin C can be useful as an earlier and superior marker of contrast-induced nephropathy in high and intermedium cardiac catheterization patients.

Eligibility Criteria:
Inclusion Criteria:

* Age over 20 years old
* Indication for coronariography and/or percutaneous coronary intervention
* Voluntary written consent for the realization of coronariography and/or percutaneous intervention and for the participation in this clinical trial
* A MEHRAN contrast-induced nephropathy score from six to fifteen.

Exclusion Criteria:

* N-Acetylcystein and Fenoldopam pre-medication
* Low risk patients according MEHRAN classification
* Cardiogenic and septic shock
* Acute renal failure by any other cause
* Patients with chronic kidney failure requiring any kind of dialysis
* Patients unable to complete follow-up
* Exposure to contrast media 48 hours prior to study
* Patients unable to give consent
* Receiving contrast media other than non-ionic
Severe Acute Respiratory Infection - Preparedness (COVID-19 and Influenza)

Severe Acute Respiratory Infection (SARI) is defined by the World Health Organization (WHO) as acute respiratory infection with a history of fever ≥38°C and cough for less than 10 days duration that requires hospital admission. SARI-PREP is a multi-center consortium funded by the CDC Foundation being assembled with the goal of providing the infrastructure to rapidly collect prospective data on clinical risks and outcomes, hospital-level stress, and biologic specimens that will aid in the rapid development of diagnostic and treatment approaches. A current example of a form of SARI to be targeted by SARI-PREP is COVID-19 the acute respiratory infectious disease caused by SARS-CoV-2 infection. COVID-19 has a broad set of manifestations and severity with a subset of affected patients developing severe disease leading to respiratory failure and other forms of organ dysfunction. As with many outbreaks of novel viral pathogens causing SARI there was no efficacious therapeutic intervention at the beginning of the COVID-19 pandemic. Furthermore, while there is emerging knowledge of clinical risks for severe COVID-19, there remains a paucity of information about the viral dynamics and host responses that might indicate a patient is at high risk for poor outcomes.

The COVID-19 pandemic will be the initial target of the SARI-PREP consortium with the overall goal of developing a multi-institutional collaborative network of Acute Care Hospitals that will rapidly enroll, sample, and follow patients admitted with severe COVID-19 and to develop research protocols to rapidly determine demographic, clinical, host molecular, virologic, and institutional correlates of outcome. Overall, the information gained from this effort will help to rapidly inform and improve clinical management of epidemic/pandemic SARI patients.


Eligibility Criteria:
Inclusion Criteria:

* Admission to an acute care or intensive care unit with a clinical syndrome of lower respiratory tract infection suspicious for viral SARI:
* fever
* cough
* AND (radiographic infiltrates by imaging (chest x-ray, CT scan, etc.) OR SpO2 ≤ 94% on room air OR requiring new supplemental oxygen (above baseline if preexisting) OR requiring invasive or non-invasive mechanical ventilation).
* confirmed viral cause for SARI by respiratory viral RT-PCR testing.

Exclusion Criteria:

* Prisoners or wards of the state
* Inability to consent or lack of availability of legal surrogate
* Do not attempt resuscitation/do not intubate status on admission
Clinical and Functional Results After Total Elbow Arthroplasty

Analysis of clinical and functional outcomes after a total elbow arthrosplasty, all indications combined, with a minimum follow up of 24 months The hypothesis is that there a significant improvement after an elbow replacement, no matter what the surgery indication is


Eligibility Criteria:
Inclusion Criteria:

* Total elbow arthroplasty, all indication combined

Exclusion Criteria:

* Less than 24 months of follow up
* Revision of total elbow arthroplasty
Trial of BMS-986012 in Combination With Platinum and Etoposide

The purpose of this this study is to administer BMS-986012 in Combination with Platinum and Etoposide as First-line Therapy in Extensive Small Cell Lung Cancer.


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Male and Females 18 years of age or older
* Pulmonary SCLC documented by histology or cytology
* Extensive disease (Stage IV) SCLC
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

* Prior systemic therapy for lung cancer
* Symptomatic brain metastases
* Grade 2 peripheral neuropathy
* Active or chronic infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV
* Other active malignancies or prior malignancy within 2 years

Other protocol defined inclusion/exclusion criteria could apply
A Study Comparing the Drug Exposure in Humans After Administration of a 50 mg Tablet of Sertraline Hydrochloride as Compared to a 50 mg Capsule of Sertraline Hydrochloride Under Fasted (Nonfed) Conditions

This study is designed to determine differences in drug exposure in subjects after being administered 50 mg tablets of sertraline hydrochloride as compared to drug exposure after administering 50 mg capsules of sertraline hydrochloride under fasted (nonfed) conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 21 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>45 kg (99 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy)
Ratio of ''Central Venous-to-Arterial Co2 Gap'' to ''Arterial-to-Central Venous O2 Content Gap'' in Septic Shock

The high ratio of "central venous to arterial carbon dioxide" to "arterial to central venous oxygen content " is associated with elevated lactate in patients with septic shock.

So, the aim of the present study is to evaluate the ratio of "central venous-to-arterial CO2 tension or content" to "arterial-to-venous O2 content'' as an indicator of anaerobic metabolism in septic shock.

This is a prospective single center observational study that will be conducted in adult intensive care unit of Ain Shams University After being approved by local institutional ethic committee (Ain Shams University, Egypt). Informed consent was obtained from each participant's next of kin. The investigator will study mechanically ventilated participants. the attending physician's decision is to give IV fluids to participants due to the presence of at least one clinical sign of inadequate tissue perfusion due to septic shock : (a) systolic arterial pressure \<90 mmHg, mean arterial pressure \<65 mmHg, or the need for vasopressor infusion; (b) skin mottling; (c) lactate level \>2 mmo/L; or (d) urinary output \<0.5 mL/kg/h for ≥2 h. Jugular central venous and arterial catheters will be in place by the attending physician. Investigator will confirm the position of the tip of the central venous catheter in the superior vena cava or upper part of the right atrium on chest radiograph. Participants will be monitored by Flo Trac device as a part of routine management in local ICU.

A first set of measurements will be performed, including hemodynamic and tissue oxygenation variables (heart rate, mean arterial pressure, cardiac index (CI), oxygen delivery (DO2), oxygen consumption (VO2), Central venous oxygen saturation (ScvO2), arterial lactic acid level, central venous to arterial carbon dioxide tension difference (∆PCO2), central venous to arterial CO2 content difference (∆ContCO2), arterial-to-central venous oxygen content difference (∆ContO2), ∆ContCO2/∆ContO2 ratio and ∆PCO2/∆ContO2 ratio. 500 ml of isotonic saline 0.9% will be infused to the participants via a specific venous line over 15 minutes. Immediately after volume expansion, a second set of the previous measurements will be recorded. Ventilation parameters, Norepinephrine dose and sedation drugs will be kept constant during the fluid challenge.

After fluid challenge, Participants with an increase in cardiac index ≥15% will be defined as fluid responders. Fluid responders will be divided into 2 groups based on increase in oxygen consumption (VO2) ( \< or ≥15%).

Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years.
2. Suspected infection focus
3. Mean blood pressure \<65 mmHg, or required vasopressor infusion.
4. Lactic acid level \>2 mmol/l.
5. Mechanically ventilated patients.

Exclusion Criteria:

1. Age equal or less than 18 years.
2. Pregnant women.
3. Liver cirrhosis Child-Pugh C.
4. Chronic obstructive pulmonary disease.
5. Previous episode of septic shock within the last 3 months.
6. Patients with a contraindication to volume expansion.
Investigating Veregen ™ 15% Ointment Treatment For Non-facial Verrucae in Pediatric Patients: A Pilot Study

The purpose of this study is to investigate topical treatment with Veregen™ 15% ointment as a single therapeutic agent and compare it to combination therapy with Veregen ™ 15% ointment and a single destructive treatment by cryotherapy for non-facial verruca vulgaris in the pediatric population. This novel treatment modality may be useful in the pediatric dermatology community offering a less invasive, painless option for treatment of non-facial verruca vulgaris.

The purpose of this study is to investigate topical treatment with Veregen™ 15% ointment as a single therapeutic agent and compare it to combination therapy with Veregen ™ 15% ointment and a single destructive treatment by cryotherapy for non-facial verruca vulgaris in the pediatric population. The investigators will compare the single and combination treatment modalities over identical time points in patients with non-facial verruca vulgaris. One of the current options for care for non-facial verruca includes cryotherapy, which is a painful and destructive method performed in the pediatric dermatology clinic. This study aims to establish the safety, non-invasivenature, efficiency, and efficacy of Veregen ™ 15% ointment as monotherapyfor non-facial verruca vulgaris in the pediatric population. The investigators hypothesize that Veregen ™ 15% ointment monotherapy will non-invasively treat non-facial verruca vulgaris with similar efficacy as combination therapy with a single cryotherapy treatment followed by topical application of Veregen ™ ointment. This novel treatment modality will be useful in the pediatric dermatology community offering a less invasive, painless option for treatment of non-facial verruca vulgaris.

Eligibility Criteria:
Inclusion Criteria:

* Male or female of any ethnic background
* Age between 6 years old and 16 years old
* A clinical diagnosis of non-facial verruca vulgaris
* Able to adhere to study visit schedule, Veregen ™ treatment requirements, and baseline cryotherapy treatment in half of patients
* Verruca size greater than 5 mm

Exclusion Criteria:

* Medically unstable patients
* Patients with immunosuppression
* Families who decline participation
* Verruca may not have been treated in preceding 4 weeks prior to enrollment
* Verruca may not be located on the face or genitalia
* Verruca size less than 5 mm
The Effects of Trichosanthes Root on Blood Sugar in Patients With Diabetes Mellitus

Diabetes mellitus (DM) locates fifth of ten leading death etiology, the population of diabetic patients has a tendency of increase. Trichosanthes root is called as Tian Hua Fen, According to traditional Chinese writing record that Trichosanthes root has the action of downbear fire, moisten dryness, and slippery phlegm, and release thirst. The Trichosanthes root may lower blood sugar levels in the modern study. The investigators designed a double blind, randomized controlled study, a total of 60 diabetic patients with high blood sugar were divided into treatment and control groups, and each group was 30 patients. In the treatment group, oral administration of Trichosanthes root 1.5 g, bid/day for 84 days continuously; in the control group, oral administration of Trichosanthes root placebo 1.5 g, bid/day for 84 days continuously. The main outcome measure was the changes of plasma blood sugar and Glycated hemoglobin A1c (HbA1c) levels changed before and after Trichosanthes root treatment. The investigators predict the results of the present study indicated that Trichosanthes root can improve plasma blood sugar and glycated hemoglobin A1c levels.


Eligibility Criteria:
Inclusion Criteria:

1. Early diagnosis Type Ⅱ Diabetic patients who Glycated hemoglobin A1c level between 7.0% and 9.0% (including) , and after three months of diet and exercise control.
2. The subject who was taking hypoglycemic drugs Metformin, the maximum total amount of ≦ 1500 mg / day.
3. Age ranged between 20 and 80 years (including).

Exclusion Criteria:

1. Pregnancy or breast-finding.
2. Allergy to test medicine.
3. Type I Diabetic patients.
4. Bleeding tendency.
5. The participants who suffered from serious disorders, such as congestive heart failure, myocardial infarction, chronic obstructive pulmonary disease, renal failure, cancer or stroke etc.
6. Irritable or anxious patients who cannot be assessed.
7. Refuse to sign the agreement.
8. The values of SGOT and SGPT levels were more than normal limit triple, or the value of creatinine level was more than normal limit.
9. Plasm glucose(Glucose AC) level in fasting state ≧ 300 mg / dL.