cyrilzakka/clinical-trials huggingface dataset:
Exercise Testing in ICU Survivors to Evaluate ICU-acquired Weakness

This study aims to investigate how sepsis and shock can impair microcirculation in intensive care unit (ICU) patients, which can lead to long-lasting muscle weakness/dysfunction or ICU-Acquired Weakness (ICU-AW) and exercise limitations.

This longitudinal study will assess microvascular function through four (4) follow-ups after ICU discharge: at (i) 7 days, (ii) 3 months, (iii) 6 months, and (iv) 12 months. The goal is to understand how microvascular dysfunction contributes to ICU-AW and long-term exercise limitation in ICU survivors.

Specific goals are:

1. Characterize the natural trajectory of skeletal muscle microvascular function in ICU survivors using high-resolution NIRS.
2. Demonstrate an impairment in skeletal muscle microvascular oxygen delivery and cardiovascular blood flow regulation in ICU survivors.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have received mechanical ventilation for at least 7 days in the MICU or SICU and have subsequently been discharged.
* Patients enrolled in existing microvascular monitoring study in the ICU regardless of duration of mechanical ventilation.

Exclusion Criteria:

* Unable to provide consent
* Trajectory of health expected to be significantly limited in the upcoming 12 months
Effect of Dexamethasone Implant on Optic Disc

This study evaluates the effect of dexamethasone implant which is an intraocular corticosteroid on the optic nerve fibers. Retinal nerve fiber thicknesses and optic nerve head pitting rates were measured before and 6 months after the injection.

Diabetic macular edema is the most frequent ocular complication of diabetes resulting in irreversible loss of vision if untreated. Dexamethasone implant implant is used to treat macular edema due to diabetes. It stay in the vitreous for 6 months after intravitreal administration.

Dexamethasone implant can lead to retinal nerve fiber layer and optic nerve damage by both increasing intraocular pressure and its direct effect on neural tissue during the effective 6-month period.

Eligibility Criteria:
Inclusion Criteria

Patients who underwent first time intravitreal injection

Exclusion Criteria

Previously received any surgery

Proliferative diabetic retinopathy

Glaucoma or glaucoma suspicion

Optic disc fatigue

Optic disc edema

Uveitis and media opacity

Blurred of image clarity
Evaluating the Efficacy of Microneedling in the Treatment of Androgenetic Alopecia

Androgenetic Alopecia is the most common non scarring alopecia worldwide. Treatment of which has been limited with few options for medical and surgical treatment, the cost of the latter being prohibitive for many. Recently there have been several new modalities proposed as treatment, namely Microneedling and Platelet Rich Plasma.

Microneedling has been shown to overexpress hair growth factors which may enhance or stimulate miniaturized hairs to grow. It has also been shown to increase the absorption of topical products significantly. The exact mechanism of action of Microneedling is still being delineated.

In this study, we aim to do a half lesional study with global photographs and hair counts done at the start of , week four and week twelve. Patients would be needled once weekly after application of topical anaesthetic (5% EMLA). If by week six there is significant regrowth (\>30%), then total lesional needling will be done. Patients will only be using topical 5% Minoxidil throughout the study as this will prolong the effects of the regrowth.


Eligibility Criteria:
Inclusion Criteria:

1. Men between the ages 18-65.
2. Disease Stage: Norwood Hamilton IIIa-IV.
3. Length of time with disease \< 10 years.

Exclusion Criteria:

1. Must not have other concurrent hair disease.
2. Have not used any oral anti androgen (Finasteride or Dutasteride) in the past six months. If so, a washout period is needed. One month for Finasteride and three months for Dutasteride.
3. Patients under the age of 18.
4. Patients who are unable to offer consent.
Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment

This study aims to develop a standardized universal imaging protocol for ICG-guided fluorescent total thyroidectomy, including quantitative evaluations of the fluorescent signal. Therefore, patients will undergo thyroid surgery (total thyroidectomy) with the use of ICG fluorescence.

Background Thyroid surgery volume continues to increase worldwide over the past few decades. During a total thyroidectomy (TTx), the ultimate goal is to remove all thyroid tissue, whereas damage to adjacent tissue is prevented. However, iatrogenic hypoparathyroidism, as a result of surgical removal or damage to the parathyroid glands, occurs in approximately 30% of the cases. In 2016 near-infrared fluorescence guided surgery with indocyanine green (ICG) was proposed for visualizing viability and blood supply of parathyroid glands during TTx. ICG can visualize tissue perfusion, since it becomes completely and permanently fixed to plasma proteins once in the bloodstream, and circulates in the intravascular compartment only. However, one of the limitations of ICG imaging is the subjectivity of the interpretation of fluorescence, which makes the assessment of images inconsistent among studies. There is a clear need for standardization of the evaluation of the perfusion with ICG, since visual evaluation of the fluorescent signal of ICG is not sufficient to reliably predict the perfusion of parathyroid glands.

Main research question To develop a standardized universal imaging protocol for ICG-guided fluorescent total thyroidectomy including quantitative evaluations of the fluorescent signal.

Design This will be a proof-of-concept , prospective cohort study of patients undergoing a total thyroidectomy with ICG-guided fluorescent surgery to evaluate tissue perfusion The main study endpoint is quantification of the fluorescent signal of ICG. Secondary outcomes are data from surgery, postoperative lab values (including calcium, PTH, albumin) and postoperative medication use.

Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥ 18 years
2. Patients undergoing total thyroidectomy as surgical procedure for thyroid cancer, Graves' disease or goiter
3. Patients are eligible for surgery
4. Patients are mentally competent and are able and willing to comply with study procedures
5. Written informed consent

Exclusion Criteria:

1. Patients with a known allergy to ICG or iodinated contrast
2. Pregnant or lactating women
3. Patients with previous neck surgery
New Therapeutic Strategies for Inhibitory Control in Alcoholism

This experimental research studies the efficacy of two different treatments for inhibitory control improvement in alcohol-dependent individuals, one consisting of Retrieval-Extinction Learning ( alcohol AAT Task) and the other consisting in rTMS of the right dorsolateral prefrontal cortex.

The main purpose of this study is to demonstrate the efficacy of two different treatments for inhibitory control improvement (measured by the modified Stop signal task): a behavioral treatment based on Retrieval-Extinction Learning, through the AAT (Alcohol Approach Avoiding Task) and a treatment based on the neuromodulation of prefrontal cortex through the rTMS (repetitive transcraneal magnetic stimulation) technique. To carry out this study, 105 alcoholic patients will be compared for clinical variables (abstinence/relapses), self-informed (UPPS) and behvavioral impulsivity (Stop signal task), along with biological measures for polymorphism determinations. Alcohol-dependent individuals will be divided into 4 groups of study (1:1 proportion for Retrieval-Extinction Learning with AAT and 2:1 (double for the effective technique comparing to placebo/control) for rTMS): Group 1 (N=30): exposure to an alcohol-related video followed by AAT; Group 2 (N=30): neutral-content video followed by AAT; Group 4 (30): active stimulation rTMS (10 Hz) ; Group 4 (N=15): placebo stimulation SAM.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 50 years old.
* A minimum of 28 days of abstinence
* Consent to participate in the study.

Exclusion Criteria:

* Subjects with other substance dependence ( with the exception of tobacco)
* Subjects with a history of brain injury or neurological diseases
* Denial for study participation
* Non-spanish speakers
* rTMS selected participants with be assed in order to discard epilepsy, presence for metallic elements and CNS valves
A Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan

This study is conducted in Asia. The aim of the study is to evaluate the safety and efficacy of NovoSeven® (activated recombinant factor VII, eptacog alfa (activated)) during bleeding episodes and for the prevention of bleeding during surgery/delivery in patients with Glanzmann's thrombasthenia (GT)/Glanzmann's disease.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any study-related activities (Study related activity are any procedure related to recording of data according to the protocol).
* All-treated patients in the registration period

Exclusion Criteria:

* Known or suspected allergy to study product(s) or related products
* Septicaemia (especially, septicaemia followed severely infected patients caused by gram-negative bacteria \[The risk of DIC (disseminated intravascular coagulation) caused by endotoxemia could not denied\]
* Patients with a history of hypersensitivity to any of the product components
FA Clinical Outcome Measures

This multicenter natural history study aims to expand the network of clinical research centers in FA, and to provide a framework for facilitating therapeutic interventions. In addition, this study will lead to the development of valid yet sensitive clinical measures crucial to outcome assessment of patients with Friedreich's Ataxia. This study will support genetic modifier studies, biomarker studies, and frataxin protein level assessments by building a sample repository.

This natural history study is no longer recruiting under this protocol NCT03090789 but remains actively recruiting under the harmonized study (UNIFAI) NCT06016946.

Friedreich's ataxia (FA) is a rare autosomal recessive degenerative disorder characterized by ataxia, dysarthria, sensory loss, diabetes and cardiomyopathy. The discovery of the abnormal gene in FA and its product (frataxin) has provided insight into possible pathophysiological mechanisms and novel approaches to treatments in this disease. While such methods for assessing disease progression may be useful, evaluation in clinical trials will require specific clinical outcome measures.

This is a multicenter natural history study which aims to expand the network of clinical research centers specializing in Friedreich's Ataxia and to advance clinical care, research and therapeutic approaches in FA through the development and validation of clinical outcome measures. Study sites aim to collect quantitative serial clinical data on patients with FA and expand the existing research network. In addition, the study will support various genetic modifier studies, biomarker studies, and frataxin protein level assessments in patients with FA, in carriers, and in controls.

This study will recruit up to 2000 patients with Friedreich ataxia worldwide, to be assessed annually for up to 15 years. All individuals with a genetic or clinical diagnosis of FA can participate.

Study participation involves yearly assessments of a core set of clinical measures and quality of life assessment measures in addition to optional collection of a cheek swab and/or blood sample.

Eligibility Criteria:
Inclusion Criteria:

1. Males or females age 4 to 80 years.
2. Genetically confirmed diagnosis of FA (for carrier/control cheek swab and blood samples this is not required).
3. Clinically confirmed diagnosis of FA, pending confirmatory genetic testing through a commercial or research laboratory (for carrier/control cheek swab and blood samples this is not required).
4. Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion Criteria:

1) Signs or symptoms of severe cardiomyopathy (such as congestive heart failure)
Evaluation of the CardioSond Electronic Stethoscope in the Detection of Coronary Artery Disease

The study is designed to evaluate the predictive accuracy of the CardioSond digital electronic stethoscope in the detection of coronary artery disease (CAD) in patients with and without known disease who are referred to cardiac computed tomography angiography (CT scans).

The CardioSond is a noninvasive medical device which detects heart sounds using ultrasensitive acoustic technology. The CardioSond produces a flow micro bruit score which is used to determine the likelihood of coronary artery disease.

The CardioSond exam will be given to patients two times: once prior to administration of vasodilators and potential beta blockade agents as part of the normal cardiac CT angiography protocol and again immediately post CT angiography. No other data will be taken on the patient and the patients involvement in the study will cease after data collection.

CT angiography data will be analyzed at a core lab at Medstar Research Institute and withheld from SonoMedica until all CardioSond acoustic data is analyzed and flow micro bruit scores are determined.

A data review panel lead by the principal investigator will examine the results of both the CardioSond and CT angiography data to determine the comparative accuracy of the CardioSond in detecting CAD in the study population.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to sign an informed consent.

Exclusion Criteria:

* Inability to provide informed consent
* History of prior myocardial infarction, percutaneous coronary intervention (i.e. stents) or coronary artery bypass graft surgery
* Heart rate over 70 beats per minute post beta blockade
* Artery calcification resulting in non-diagnostic CT angiographic images
* Supraventricular or ventricular arrhythmias that would be expected to affect CT angiography image quality (e.g. atrial fibrillation, atrial flutter, ventricular tachycardia, bigeminy and trigeminy). Patients with isolated premature atrial contraction and premature ventricular contractions may enroll
* Any pulmonary condition that would create abnormal physical findings that would interfere with the fidelity of the cardiac sound recordings (e.g. obstructive pulmonary disease, such as asthma or COPD, with audible wheezing)
* Presence of audible aortic or pulmonic diastolic murmurs, tricuspid or mitral flow diastolic murmurs or continuous murmurs
* Any chest wall configuration preventing adequate contact between the CardioSond acoustic recording sensor and precordium
* Any medical condition that would be expected to affect CT angiography image quality
Preventive Arterial Wall Phenotype and Low-dose Fluvastatin/Valsartan Combination

The study was designed to test whether short-term treatment with a very low-dose combination of fluvastatin and valsartan could induce improvement of endothelial function, arterial stiffness, vascular inflammation, oxidative stress and expression of protective genes in subjects with moderate cardiovascular risk.

The largest population that suffers from cardiovascular events are subjects at moderate cardiovascular risk. However, no effective and safe preventive treatment is available for this population. This study aimed to investigate whether their arterial wall phenotype could be turned to a preventive direction by low-dose fluvastatin/valsartan combination (low-flu/val).

Twenty males at moderate cardiovascular risk (as classified by SCORE) were blindly randomised into the intervention group (n=10, low-flu/val: 10 mg/20mg) or control group (n=10, placebo). At inclusion and after 30 days of treatment, brachial flow-mediated dilatation (FMD), beta stiffness coefficient, carotid pulse wave velocity (c-PWV), carotid-femoral PWV, reactive hyperaemia index, high-sensitivity C-reactive protein (hs-CRP), interleukin 6, vascular cell adhesion molecule 1, total antioxidant status and expression of several protective genes (SIRT1, mTOR, NF-κB1, NFE2L2, PRKAA1) were followed.

Eligibility Criteria:
Inclusion Criteria:

* moderate cardiovascular risk according to Systematic Coronary Risk Estimation (SCORE) risk charts of the European Society of Cardiology
* males
* aged between 40 and 55 years

Exclusion Criteria:

* diabetes mellitus
* manifest peripheral artery disease or carotid artery disease
* acute infection
* chronic diseases
* present therapy with fluvastatin and/or valsartan
A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Combination Therapy of T-614 and Methotrexate in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate

The purpose of this study is to evaluate the efficacy and safety of T-614 versus placebo when added to ongoing, stable-dose methotrexate therapy in patients with persistently active rheumatoid arthritis


Eligibility Criteria:
Inclusion criteria:

* Subjects who have a diagnosis of Rheumatoid Arthritis by the ACR criteria
* Age greater or 20 years and less than 70 years old

Exclusion criteria:

* Subject who is considered by the investigator, for any reason, to be an unsuitable candidate for the study
* Women of childbearing potential who are not practicing a successful method of contraception, or wish to become pregnant
Pilot Study of 18F-DCFPyL PET/CT in the Evaluation of Men With an Elevated PSA Following Radical Prostatectomy

This pilot study aims to investigate the diagnostic utility of 18F-DCFPyL, a novel low-molecular weight PSMA PET/CT imaging agent, in men with an elevated PSA following radical prostatectomy.

18F-DCFPyL is a novel low-molecular weight PSMA imaging agent. A recent study of patients with metastatic prostate cancer found that PSMA PET/CT identified more sites of disease than conventional imaging with CT, MRI and bone scan. In this study we aim to investigate 18F-DCFPyL PET/CT in patients with an elevated PSA following radical prostatectomy. During the course of this study, patients will undergo two 18F-DCPyL PET/CT scans. The first scan will take place within 45 days of staging imaging and the second will take place following six months of standard of care therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* History of adenocarcinoma of the prostate treated with radical prostatectomy
* Serum PSA level ≥0.2 ng/mL at least 45 days prior to study enrollment
* Completed staging evaluation with bone scan as well as CT or MRI of the abdomen and pelvis at least 45 days prior to study enrollment

Exclusion Criteria:

* Intention to enroll in a blinded therapeutic clinical trial
* History of other malignancy diagnosed within the last three years (the exception of squamous cell or basal cell carcinoma of the skin)
Fluzoparib Combined With Dalpiciclib for Platinum Resistant Recurrent Ovarian Cancer

This study aims to investigate the safety and efficacy of combination therapy of Fluzoparib combined With Dalpiciclib for platinum-resistant recurrent ovarian cancer through a single-center, prospective, single-arm, phase II clinical trial, to improve the overall treatment level and prognosis of platinum-resistant ovarian cancer.

1. Overall Design: This trial is a single-center, prospective, single-arm, phase II clinical trial to evaluate the safety and efficacy of combination therapy of Fluzoparib combined With Dalpiciclib for platinum-resistant recurrent ovarian cancer.
2. Experimental observation indicators: 1) Main indicators: progression-free survival (PFS), 2) Other indicators: overall survival (OS), objective response rate (ORR), and adverse reactions.
3. Sample size calculation: The median PFS of platinum-resistant recurrent ovarian cancer patients is 3.8 months. In comparison, the experimental group is expected to have a median PFS of 7 months, with an alpha value of 0.05. Following up for 1 year and considering a 10% dropout rate, this study plans to include 30 platinum-resistant recurrent ovarian cancer patients.
4. Data Processing: Enter data and use SPSS statistical software for statistical analysis. Statistical analyst: Clinical Statistics Department of Fudan University Cancer Hospital. Mailing address: 270 Dong'an Road, Shanghai.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years old;
2. Sign the informed consent form;
3. Histologically-confirmed epithelial ovarian or fallopian-tube cancer or primary peritoneal cancer.
4. Tumor recurrence or progression within 6 months after using platinum-based drugs;

Exclusion Criteria:

1. Any uncontrolled medical condition that may put the patient at high risk during treatment .
2. Receipt of any other investigational medicinal product within the last 30 days before randomization.
3. Patients with ovarian cancer excluded by pathological or clinical diagnosis;
4. Physical intolerance patients;
5. Patients who are unwilling to participate in the clinical trial.
18F-Fluciclovine PET to Distinguish Tumor Progression From Radiation Necrosis

The purpose of this study is to evaluate whether 18F-fluciclovine PET/CT of the brain, is able to distinguish radiation necrosis from tumor progression in cases where MRI is inconclusive.

18F-fluciclovine is an FDA approved radioactive diagnostic agent and is injected into the participant and then taken up by cancer cells, which can then be visualized with a PET/CT scan. 18F-fluciclovine is FDA approved for the detection of recurrent prostate cancer, but is still investigational for the purposes of this study.

The primary objective of this study is to estimate the accuracy of 18F-fluciclovine PET in distinguishing radiation necrosis from tumor progression. Accuracy will be assessed via receiver operating characteristic curve analysis, as well as by calculating sensitivity and specificity.

Secondary objectives of this study are to assess which factors may influence accuracy of 18Ffluciclovine PET in distinguishing radiation necrosis from tumor progression and to compare the accuracy of each of the qualitative and quantitative metrics.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must have a confirmed diagnosis of brain metastases.
* Subjects must have received prior intracranial SRS at least once for brain metastases. Prior WBRT is allowed.
* Subjects must have had a clinical tumor protocol MRI of the brain including a DSC-MR perfusion sequence, which is equivocal for radiation necrosis versus tumor progression within 30 days of treatment scan. "Equivocal" will be defined as being inconclusive for radiation necrosis versus tumor progression as determined by the study neuroradiologist.
* Physician assessed life expectancy of ≥ 6 months.
* Subjects must have the ability to understand and the willingness to sign a written informed consent document.
* For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required.

Exclusion Criteria:

* Subjects who have experienced a prior anaphylaxis reaction to 18Ffluciclovine are not eligible.
* Females pregnant at the expected time of 18F-fluciclovine administration are not eligible due to potential harm to the fetus from exposure to radiation. Women who could be pregnant require a negative pregnancy test to be eligible.
* Women who are breast feeding at the expected time of 18F-fluciclovine administration are not eligible due to potential harm to the infant from exposure to radiation.
* Subjects contraindicated for MRI.
* Subjects unable or unwilling to comply with study requirements are not eligible.
* Major medical illness or psychiatric impairments, which in the investigator's opinion, will prevent completion of protocol therapy and/or preclude informed consent.
* Brain metastases from primary lymphoma, germ cell tumor, or small cell carcinoma.