cyrilzakka/clinical-trials huggingface dataset:
Cerebral Microstructural Changes Following Mild Traumatic Brain Injury

This study examine the possible microstructural changes in the middle brain after mTBI using diffusion MRI

There is a need for clinical and biological markers at 2-3 month to screen people in risk of getting chronic post-concussion symptoms (PCS) but also biomarkers in the brain to find out if this group with prolonged symptoms has measurable changes in the brain which could explain the persisting symptoms.

Several biomarkers and brain areas have been investigated as possible sites of injury after mild traumatic brain injury (mTBI). The nature of the diffuse PCS makes corpus callosum (CC), thalamus (THA) and hippocampus (HIP) interesting because of their central position and connection to widespread motor, sensory and cognitive processes and other brain areas.

In most prior studies conventional magnetic resonance imaging (MRI) has failed to detect pathology especially in the later phase. Diffusional Kurtosis Imaging (DKI) and Diffusional Tensor Imaging (DTI) are more sensitive to microstructural changes and might serve as biomarkers in the middle brain after mTBI.

It is hypothesized that there will be a difference in the microstructure of the thalamus, corpus callosum and hippo campus as measured with DKI between two groups of mTBI subjects with and without PCS. Secondary it is hypothesized that DKI are more sensitive than DTI in the measure of microstructural changes.

Eligibility Criteria:
Inclusion Criteria:

* Concussion caused by a head trauma according to the diagnostic criteria recommended by the Danish Consensus Report on Commotio Cerebri within the last 2-5 months. The criteria are based recommendations by the WHO Task Force, but with the amendment, that there must have been a direct contact between the head and an object in order to rule out acceleration - deceleration traumas.
* Age 18 to 30 years at the time of the head trauma.
* Able to understand, speak and read Danish.
* Patients with symptoms at least three items on the Rivermead Post Concussion Symptoms Questionnaire (RPQ) rated as moderate or severe problem. PCS have to be subjectively rated as causing substantial impairment in daily life. Patients with out symptoms (controls) having no problems on the RPQ.

Exclusion Criteria:

* 1. Objective neurological findings from neurological examination and / or acute trauma CT scan, indicating neurological disease or brain damage.
* Previous concussion leading to persistent PCS within the last two years.
* Severe misuse of alcohol, prescription drugs and / or illegal drugs.
* Psychiatric morbidity or severe neurological disease that impedes participation in the treatment, i.e. Bipolar Disorder, autism, psychotic disorder (life time), multiple sclerosis etc..
* Suitable for MRI examination
How Smoking Causes COPD: Examination of Immune System Changes

A breathing condition known as "chronic obstructive pulmonary disease" (COPD) caused by cigarette smoking is a major health problem. The way by which smoking leads to lung disease is uncertain. Recent research done in animals provides a description of specific changes (that is a reduction) in these immune cell types as a result of cigarette smoke exposure. The study you have been asked to participate in is a pilot study to see if similar changes occur in humans who smoke. The purpose of this study is to evaluate this new method of testing blood in 3 groups of 10 people: normal non-smoking subjects, subjects who smoke with no history of lung disease and subjects who smoke and have smoking related COPD.

The mechanism by which smoking leads to damage to lung tissue in susceptible hosts, is uncertain. Recently there has been description of specific changes (that is reduction) in the number and activity of certain key immune cell types - dendritic cells- as a result of cigarette smoke exposure. This work was done in animal models and we would like to develop methods that will allow us to examine if similar changes occur in humans who smoke. Reduced number and activity of dendritic cells would be expected to lead to increased incidence of infection - a common problem in patients with COPD.

Since dendritic cells come to the lung from the bloodstream, and one can detect them in the circulation, we will look at the dendritic cells that are present in the peripheral blood.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 40 years
* Healthy Subjects - Non smokers
* FEV1/FVC \> 70% predicted
* Current Smokers - \> 10 pack year smoking history
* FEV1/FVC \> 70% predicted
* Current Smokers with COPD - \> 10 pack year smoking history
* FEV1/FVC \< 70% predicted
* Able to give informed consent

Exclusion Criteria:

* Healthy Subjects - Reside with smokers
* History of lung disease
* Current Smokers - History of lung disease
A Study of PTX-200 (Triciribine) Plus Cytarabine in Refractory or Relapsed Acute Leukemia

A phase I-II open label study of PTX-200 in combination with cytarabine in the treatment of relapsed or refractory acute leukemia.

Study design: Phase I/II study The Phase I study is open-label with four increasing dose levels for up to four 21-day cycles. Safety and activity will be evaluated at the end of each cycle.

The Phase II study is open label with administration of the recommended phase dose of PTX-200 for up to four 21-day cycles. PTX-200 will be co-administered with cytarabine in both the Phase I and Phase II parts of the study.

Eligibility Criteria:
Inclusion Criteria:

* Pathologic confirmation of the diagnosis of AML, ALL (acute lymphoblastic leukemia), or blast-phase CML (chronic myelogenous leukemia)
* Age ≥ 18 years
* ECOG Performance Status 0-2
* Patients must be able to give adequate informed consent

Exclusion Criteria:

* Hyperleukocytosis with ≥ 30,000 leukemic blasts/µL blood (hydroxyurea permitted up to 24 hours prior to beginning study drugs)
* Uncontrolled Disseminated Intravascular Coagulation (DIC)
* Uncontrolled diabetes mellitus
* Active, uncontrolled infection
Esophageal Temperature During PVI Using Q-DOT Micro

This study will assess how two different ablation strategies, using two different ablation catheters during catheter ablation for paroxysmal atrial fibrillation, affect the temperature of the esophagus during ablation, and the risk of injury to the esophagus.

This is a prospective randomized controlled trial, studying patients undergoing ablation involving pulmonary vein isolation for paroxysmal atrial fibrillation. Patients will be assigned to undergo conventional high-power short-duration ablation or temperature-controlled very-high-power short-duration ablation, and esophageal outcomes including temperature changes during ablation and esophageal injury as assessed by post-procedure capsule endoscopy will be compared between the groups. The hypothesis is that very-high-power short-duration ablation will lead to lower rises in esophageal temperature and lower rates of esophageal findings during capsule endoscopy.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged greater than or equal to 18 years
4. Diagnosed with paroxysmal atrial fibrillation
5. Undergoing RF catheter ablation for treatment of paroxysmal atrial fibrillation that will involve circumferential point-by-point radiofrequency ablation pulmonary vein isolation with no additional left atrial posterior wall ablation planned

Exclusion Criteria:

1. Patients who have undergone prior left atrial ablation procedures.
2. Patients where the use of the Q-DOT Micro ablation catheter in QMODE+ (i.e. temperature-controlled very-high-power short-duration ablation) is felt to be unsafe.
3. Patients who have contraindications to capsule endoscopy, or GI conditions that may increase the risks of capsule endoscopy (e.g. esophageal strictures, inflammatory bowel disease, etc)
4. Any records flagged "break the glass" or "research opt out."
The DEtermining Statin Intolerance FOr Rosuvastatin (DESIFOR) Trial

This study will enroll patients who previously were not able to tolerate being on a statin medication due to muscle-related side effects. Research has shown that many people who have muscle symptoms on statin therapy do not experience the same side effects if they try it again later. This study is part of a larger effort to:

* See how common it is for patients to still be intolerant of statin medication after trying it a second time; and
* For those patients who do tolerate being on a statin after trying it a second time, see how common it is for them to still be taking the statin 3 months after completing the main part of the study.

Patients who agree to participate will be given a 5 month randomly allocated supply of statin and placebo and track their symptoms weekly.

This study is a single center, double-blinded randomized controlled trial for patients eligible for statin therapy by current guidelines, but not on statin therapy due to a history of statin intolerance. Patients will be provided a "DESIFOR" kit which includes 5 randomly allocated 4-week blister packs of capsules containing either 20mg of rosuvastatin or placebo. While blinded to treatment, patients will document the severity of musculoskeletal symptoms every week using a numerical scale. The primary endpoint will be the difference between the mean musculoskeletal symptom score while randomized to statin therapy compared to the mean score while on placebo. After completion of the study, the results will be unblinded and reviewed at a 6 month follow-up visit with the patient and, for patients with symptoms found to not correlate with statin therapy, a trial of non-blinded statin therapy over the next 3 months will be recommended. This study will serve as a pilot study to determine the feasibility and potential benefits of a larger multicenter trial with similar aims.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 21-75 years old
* Statin eligible according to the 2013 ACC/AHA cholesterol guidelines, including individuals with:

  * Known ASCVD
  * Diabetes
  * LDL-C \> 190mg/dl
  * 10-year ASCVD risk \>7.5%
* Statin intolerant

  * Defined by discontinuation of at least 2 separate statins due to potential musculoskeletal side effects

Exclusion Criteria:

* Women who are pregnant, nursing or attempting to become pregnant.
* Individuals deemed to be at very high CVD risk and therefore appropriate for a PCSK9 inhibitor including:

  * Individuals with familial hypercholesterolemia with markedly elevated LDL-C levels
  * Individuals with known ASCVD and recurrent events
  * Individuals who are not otherwise clinically indicated to take 20mg rosuvastatin
* Individuals who experienced severe reactions in the past, including:

  * Rhabdomyolysis
  * Severe myositis
  * Anaphylaxis
Epidemiology and Management of Pediatric Anaphylaxis and Allergy in the Pediatric Emergency Department of Montpellier

Anaphylaxis is a severe life-threatening reaction following exposure to an antigen. Its incidence is progressively increasing in the general population over years, especially among children. The diagnosis can be difficult, and recommendations for follow up and prescription for an emergency kit are rarely provided after emergency visit. The Investigators will evaluate the management of pediatric anaphylaxis and clinical signs of allergy in the pediatric emergency department of Montpellier University Hospital


Eligibility Criteria:
Inclusion criteria:

* Patients evaluated at the Montpellier University Hospital, Allergy Unit ;
* Children consulting for suspected allergy from 2016 to 2020

Exclusion criteria:

- Patients under legal protection, under guardianship or under curatorship;
Comparative Study of Error Rates Between ELLIPTA® Dry Powder Inhaler (DPI) and Other DPIs

For effective drug delivery using inhalation route, it is important to use the inhalers correctly. This open-label study will evaluate the error rates during the use of ELLIPTA DPI, alone or in combination, in comparison with other DPIs. The study aims to provide clinical evidence in subjects with COPD that the reduced number of steps required to use the ELLIPTA DPI could result in fewer errors made by subjects, and therefore a more consistent treatment. Approximately 450 subjects prescribed with either of RELVAR® ELLIPTA, ANORO® ELLIPTA, INCRUSE® ELLIPTA, SYMBICORT® TURBUHALER®, SERETIDE® DISKUS®, SPIRIVA® HANDIHALER®, ULTIBRO® BREEZHALER® or SEEBRI® BREEZHALER will be included in the study and will have 2 clinical visits. At Visit 1, subjects will take their maintenance DPIs and the critical and overall errors made by subjects will be assessed. After the assessment, subjects will be instructed on correct use or informed of their correct use of their DPIs. The total duration of the study is approximately 6 weeks. ELLIPTA, SERETIDE and DISKUS are registered trademarks of the GSK group of companies. SYMBICORT and TURBUHALER are registered trademarks of the AstraZeneca group of companies. SPIRIVA and HANDIHALER are registered trademarks of Boehringer Ingelheim Pharmaceuticals. ULTIBRO, BREEZHALER and SEEBRI are registered trademarks of the Novartis group of companies.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with documented Physician's diagnosis of COPD, and currently receiving maintenance therapy.
* Aged \>=40 years of age at inclusion.
* Using one of the maintenance therapies of interest for at least 3 months prior to inclusion on the study.
* Males or females.
* Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in the protocol.

Exclusion Criteria:

* Asthma: Subjects with a current diagnosis of asthma. Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD.
* Drug/alcohol abuse: Subjects with a known or suspected alcohol or drug abuse history at screening (Visit 0) that in the opinion of the investigator could interfere with the subject's proper completion of the protocol requirement.
* Investigational product: Subjects who have received an investigational drug and/or medical device within 30 days of entry into this study (Screening/Visit 1), or within five half-lives of the investigational drug, whichever is longer.
* Investigational product: Subjects who have been trained during participation in any device study in the 6 months prior to entry into this study.
The Role and Mechanism of GPER-Hippo-CBS/H2S Pathway in Preeclampsia

The goal of this clinical trial is to learn about in health conditions. The main questions it aims to answer are:

* The pathological significance of GPER in uterine artery dilation in preeclampsia
* The Mechanism of GPER Hippo Pathway Regulating CBS/H2S in Human Uterine Artery Smooth Muscle Cells (hUASMC) This project intends to use GPER interfering RNA, YAP1 interfering RNA, in vivo perfusion experiments of human uterine artery tissue, and single cell patch clamp technology to study hypotheses under physiological/pathological pregnancy conditions at the tissue, cellular, and molecular levels, revealing a novel signal transduction pathway of estrogen stimulating vasodilation, providing new ideas for studying the mechanism of uterine artery blood flow regulation. This research result will provide new targets for intervention and treatment of diseases such as fetal intrauterine growth retardation and preeclampsia.

1. Measure the content of H2S in uterine arterial smooth muscle and circulation of normal pregnancy and PE pregnant women, and analyze the relationship between the content of H2S in uterine arterial smooth muscle and circulation of PE pregnant women and PE.
2. Knock down the GPER and overexpression of GPER in HTR-8 cells, and detect the expression of GPER, CBS, and Hippo pathway related proteins using Western blot and qRT-PCR to verify the efficiency of knockdown and overexpression. Use different concentrations of H2S donor (GYY4137) to interfere with HTR-8 cells after treatment, and use RT-PCR and Western blot to detect the mRNA and protein expression of downstream molecules YAP and TAZ in Hippo pathway in cells, respectively.

Eligibility Criteria:
Inclusion Criteria:

1. Full term pregnancy with clinical diagnosis of preeclampsia and normal pregnancy pregnant woman
2. Pregnant women undergoing lower segment cesarean section for delivery

Exclusion Criteria:

1. Combined with chronic hypertension, kidney disease, intrahepatic cholestasis, etc Other basic diseases;
2. Multiple pregnancy
3. Pregnant women undergoing vaginal delivery
4. Normal pregnant women who are\<37 weeks or\>40 weeks pregnant
A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT)

The purpose of the study was to evaluate the efficacy of ASP0113 compared with placebo as measured by a primary composite endpoint of overall mortality and CMV end organ disease (EOD) through 1 year post-transplant. Safety of ASP0113 in participants undergoing allogeneic HCT will also be evaluated.

Participants will be followed for 5.5 years post-transplant for long-term safety via an annual telephone contact.

Eligibility Criteria:
Inclusion Criteria:

* Participant is a CMV-seropositive HCT recipient
* Participant is planned to undergo either of the following:

  * Sibling Donor Transplant
  * Unrelated Donor Transplant
* Participant has one of the following underlying diseases:

  * Acute myeloid leukemia (AML)
  * Acute lymphoblastic leukemia (ALL)
  * Acute undifferentiated leukemia (AUL)
  * Acute biphenotypic leukemia
  * Chronic myelogenous leukemia (CML)
  * Chronic lymphocytic leukemia (CLL).
  * A defined myelodysplastic syndrome(s) (MDS)
  * Primary or secondary myelofibrosis
  * Lymphoma (including Hodgkin's)

Exclusion Criteria:

* Participant has active CMV disease or infection or has received treatment for active CMV disease or infection within 3 months (90 days) prior to transplant
* Participant has a modified hematopoietic cell transplant comorbidity index (HCT-CI) score ≥ 4
* Participant has received a prior HCT and has residual Chronic Graft-versus-host Disease (cGVHD)
* Participant who is scheduled to have a cord blood transplant or a haploidentical transplant
* Participant has a platelet count of less than 50,000 mm3 within 3 days prior to randomization (platelet transfusions are allowed)
* Participant has aplastic anemia or multiple myeloma
Neuropathic Pain and Traditional Medicine Syndromes in Herpes Zoster: a Cross-Sectional Study

This study investigates the relationship between neuropathic pain characteristics and Traditional Chinese Medicine (TCM) syndromes in patients with Herpes Zoster (HZ). The study aims to integrate objective pain assessment tools, such as the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale, with TCM diagnostic classifications to enhance individualized treatment strategies. Conducted at Le Van Thinh Hospital, Vietnam, this cross-sectional study includes 80 HZ patients, assessing their pain levels and corresponding TCM syndromes. The findings will contribute to a more comprehensive approach to pain management in Herpes Zoster.

This study is a cross-sectional and case series study conducted at Le Van Thinh Hospital, Ho Chi Minh City, Vietnam, between January and June 2024. It aims to evaluate the correlation between neuropathic pain characteristics and Traditional Chinese Medicine (TCM) syndromes in patients with Herpes Zoster (HZ). The study includes 80 participants diagnosed with HZ, whose pain severity is assessed using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) scale. The participants are classified into TCM syndromes based on standard diagnostic criteria, including Liver Meridian Depression and Heat Syndrome (LMD), Spleen Deficiency and Dampness Retention Syndrome (SDA), and Qi Stagnation and Blood Stasis Syndrome (QSA).

The primary objectives of the study are:

To determine the prevalence of different TCM syndromes in HZ patients. To analyze the correlation between LANSS scores and specific TCM syndromes. To provide insights into the integration of objective neuropathic pain assessment tools with traditional diagnostic frameworks.

Data collection includes demographic characteristics, medical history, pain characteristics, TCM diagnostic features, and clinical examination results. Statistical analyses include correlation tests and multinomial logistic regression to assess the relationship between LANSS pain scores and TCM syndromes.

The study findings will contribute to a better understanding of the relationship between neuropathic pain and TCM syndromes in Herpes Zoster. The results may help refine diagnostic approaches and optimize integrative treatment strategies for pain management in patients with HZ.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged ≥18 years
* Clinically diagnosed with Herpes Zoster (HZ) based on European Consensus Guidelines
* Experiencing neuropathic pain associated with HZ
* Willing to provide informed consent

Exclusion Criteria:

* History of chronic pain conditions unrelated to HZ
* Receiving immunosuppressive therapy or diagnosed with immunodeficiency disorders
* Patients who had already received antiviral or analgesic treatment before evaluation
* Patients unable or unwilling to provide informed consent
Exploratory Study of Danicamtiv in Patients With Primary Dilated Cardiomyopathy (DCM) Due to Genetic Variants or Other Causalities

The purpose of this Phase 2a study is to establish safety and preliminary efficacy of treatment with danicamtiv in patients with primary dilated cardiomyopathy (DCM) due to MYH7 or TTN variants or other causalities.


Eligibility Criteria:
Inclusion Criteria:

* For MYH7 and TTN cohorts, must have diagnosis of primary DCM (dilated cardiomyopathy), clinically stable and due to probably disease-causing variant of MYH7 or TTN
* Has adequate acoustic windows for echocardiography
* Maximum of 3 family members with same variant can be enrolled
* For the cohort of primary DCM due to causalities other than MYH7 and TTN, participant must have diagnosis of primary DCM with a cause not related to MYH7 or TTN variants

Exclusion Criteria:

* Significant structural cardiac abnormalities including valvar dysfunction on Screening transthoracic echo(s)
* Routinely scheduled outpatient intravenous (IV) infusions for heart failure (e.g., inotropes, afterload reduction, or diuretics)
* Presence of protocol specified laboratory abnormalities at Screening
* Recent acute coronary syndrome or angina pectoris (\<90 days)
* Recent hospitalization for heart failure (\<90 days)
Efficacy and Safety of Ranibizumab (Intravitreal Injections) Versus Laser Treatment in Patients With Visual Impairment Due to Diabetic Macular Edema

This study will assess the efficacy and safety of ranibizumab (intravitreal injections) versus laser treatment in patients with visual impairment due to diabetic macular edema.


Eligibility Criteria:
Inclusion Criteria:

1. Diabetes mellitus 1 or 2, HbA1c \< 11.0%, With: Clinically significant Diabetic Macular Edema in at least one eye.
2. Previous treatment with macular photocoagulation only should be considered if the investigator believes that the study eye may possibly benefit from additional photocoagulation.
3. Best corrected visual acuity score between 78 and 25 letters (Early Treatment Diabetic Retinopathy Study- ETDRS Chart - 4 meters).
4. Central foveal thickness \>250µm (Optical Coherence Tomography).
5. Diabetes medication stable in the 3 months prior.

Exclusion Criteria:

In the study eye:

1. Active intraocular inflammation.
2. Any active infection.
3. History of uveitis.
4. Structural damage within 500 microns of the center of the macula.
5. Neovascularization of the iris.
6. Uncontrolled glaucoma in either eye (Intraocular Pressure \> 24 mmHg).

Other protocol-defined inclusion/exclusion criteria may apply.