cyrilzakka/clinical-trials huggingface dataset:
Korean Brain Aging Study for Early Diagnosis and Prediction of Alzheimer's Disease

This is a prospective cohort study for cognitively normal (young and old), mild cognitive impairment, and Alzheimer's disease people

The aim of the study is 1) to search new biomarkers and develop clinically applicable early diagnosis and prediction methods of Alzheimer's disease, and 2) to investigate how the proposed lifetime risk and protective factors for Alzheimer's disease contribute to pathological hallmarks of AD or other brain changes in living human through annual comprehensive clinical and neuropsychological evaluation and biannual brain imaging (MRI and MRA, Fluorodeoxyglucose(FDG)-PET, Pittsburgh compound B (PiB)-PET), AV--1451 PET, and body specimen (blood, gene, and hair) analysis.

\* Note: AV-1451 PET will not be applied to whole subjects, but to 210 subjects (30 young CN, 60 old CN, 60 MCI, and 60 AD).

Eligibility Criteria:
Participants will be classified as either Alzheimer's disease(AD) group, mild cognitive impairment(MCI) group, elderly normal controls or young normal controls. Specific inclusion criteria for each group is described below.

\[Inclusion criteria: AD\]

* Age : 55 - 90
* Clinical Dementia Rating (CDR)=0.5 or 1
* Diagnostic and Statistical Manual-IV(DSM-IV) criteria for dementia
* National Institute of Aging and the Alzheimer's Association (NIA-AA) Probable AD dementia
* Study partner or caregiver to accompany patient to all scheduled visits
* Written informed consent

\[Inclusion criteria: MCI (amnestic)\]

* Age : 55 - 90
* Clinical Dementia Rating (CDR)=0.5
* Concern regarding a change in cognition (obtained from the subject, from an informant who knows the subject, or from a skilled clinician observing the subject)
* Lower performance in episodic memory domains that is greater than would be expected for the subject's age and educational background
* Preservation of independence in functional abilities
* Study partner or caregiver to accompany subject to all scheduled visits
* Written informed consent

\[Inclusion criteria: Elderly normal controls\]

* Age : 55 - 90
* Clinical Dementia Rating (CDR)=0
* Those with contactable Informant
* Written informed consent

\[Inclusion criteria: Young normal controls\]

* Age : 20 - 55
* Clinical Dementia Rating (CDR)=0
* Written informed consent

\[Exclusion criteria: general\]

* Past history or presence of major psychiatric illness (e.g. schizophrenia, bipolar disorder, alcohol/substance abuse or dependence, delirium)
* Significant neurologic or medical condition that can influence the mental state
* Contraindications for MRI scan (e.g. pacemaker, claustrophobia)
* Illiteracy
* Significant visual or hearing difficulty
* Taking investigational drug
* In pregnancy or breast-feeding
High Dose and Low Dose of Atorvastatin in Patients With Unstable Angina and NSTEMI (Non ST Elevation MI)

The aim of this study is to compare the effect of high dose and low dose of Atorvastatin in reduction level of C-reactive protein (CRP) in patients with unstable angina and NSTEMI (Non ST Elevation MI) attending Shahid Mohammadi hospital in Bandar Abbas.

This study compare the effect of 80mg atorvastatin followed by two 20mg daily atorvastatin with three 80mg daily atorvastatin in reduction of CRP in patients with unstable angina and NSTEMI (Non ST Elevation MI) attending Shahid Mohammadi hospital in Bandar Abbas in 2009.

Eligibility Criteria:
Inclusion Criteria:

* Patients with unstable angina with chest discomfort at rest with normal EKG or St depression (at least 0.1mv) in two consecutive leads or new and deep T inversion (at least 0.2mv)

Exclusion Criteria:

* Myocardial Infarction with ST elevation
* Diabetes Mellitus
* Previous statin use
* Current infectious disease
Advanced Goal-Directed Impedancemetry Strategy for Lung Resection Surgery

High-risk patients scheduled for lung resection surgery are increasing and theoretically eligible to perioperative individualized goal-directed fluid therapy (GDFT). However, thoracic surgery is challenging for intraoperative stroke volume (SV) and/or cardiac output monitoring because it requires lateral positioning, one-lung ventilation, and open-chest condition. Pulse contour analysis and esophageal Doppler have been proposed with contrasting results, whereas dynamic indices have been shown useless for predicting fluid responsiveness in that specific setting. Besides, more invasive technologies like thermodilution are not routinely used at the bedside by careproviders.

Chest bioreactance seems to be a feasible, safe, rustic, easy-to-use, and plug-and-play method to non-invasively and continuously monitor SV and cardiac output in thoracic cancer surgery patients, able to detect significant spontaneous and pharmacologically-induced changes over time. The impact of chest bioreactance on patients 'outcome remains however to be demonstrated.

Indeed, the routine fluid management in patients undergoing lung resection surgery could be responsible of hypovolemia/hypoperfusion and/or hypervolemia/congestion leading to postoperative complications.

The present national prospective multicenter randomized simple blind study aims to demonstrate that an individualized goal-directed fluid therapy (GDFT) driven by chest bioreactance improves outcomes within 30 days in lung resection surgery patients when compared with a standard of care. As double blind is not possible, an adjudication committee, whose members will be unaware of the procedure assignments, will adjudicate all the clinical outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Adults (≥ 18 years old)
* High-risk patients (ASA score ≥ 3 and/or ventilatory deficit (defined as FEV1≤70% and/or VC≤70%) and/or AKI risk index ≥ III and/or modified clinical Lee Criteria ≥2) undergoing elective open-chest or video-assisted or robotic lung resection surgery
* Patients who have provided written informed consent to participate in the study
* Patients affiliated with a social health insurance

Exclusion Criteria:

* Pleural or mediastinal resection surgery
* Emergency surgery (Less than 24h)
* Patients unable to understand the purpose of the study
* Patients participating in another trial that would interfere with this study
* Female patients who are pregnant, lactating or women of child-bearing potential without effective methods of contraception
* Female patients with positive β-HCG blood test
* Patients under judicial protection (guardianship, curatorship)
Study of an Investigational Drug, RO7239361 (BMS-986089), in Ambulatory Boys With DMD

The purpose of this study is to determine the safety and tolerability of RO7239361 in boys with Duchenne Muscular Dystrophy with any genetic mutation.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with DMD
* Able to walk without assistance
* Able to walk up 4 stairs in 8 seconds or less
* Weigh at least 15 kg
* Taking corticosteroids for DMD

Exclusion Criteria:

* Ejection fraction \< 55% on echocardiogram, based on central read
* Any behavior or mental issue that will affect the ability to complete the required study procedures
* Previously or currently taking medications like androgens or human growth hormone
* Use of a ventilator during the day
* Unable to have blood samples collected or receive an injection under the skin
* Treatment with exon skipping therapies 6 months prior to study start
* Treatment with ataluren or any investigational drug currently or within 5 half-lives prior to study start
Gastrointestinal Tolerability of MMF vs EC-MPS in Maintenance Transplant Patients Treated With Calcineurin Inhibitors

The purpose of the study is to assess the gastrointestinal tolerability of EC-MPS compared to MMF in maintenance transplant patients on a calcineurin inhibitor regimen, who require MMF dose reductions of 25% or more due to GI complications. The tested hypothesis is that the EC-MPS treatment is superior to the MMF therapy in terms of tolerability and that patients on the EC-MPS formulation will be able to tolerate higher doses compared to those on MMF.

The use of mycophenolate mofetil (MMF) in combination with a calcineurin inhibitor (CNI: tacrolimus or cyclosporine) has been shown to improve graft survival in renal, cardiac and liver transplantation patients. However, its use has been associated with significant side effects, including gastrointestinal complications, causing dose reductions, interruption or termination of the therapy. An alternate formulation: enteric coated mycophenolate sodium (EC-MPS) was designed to alleviate the severity of upper gastrointestinal side effects. Several trials detailed in the protocol suggest a benefit in GI related health following conversion from MMF to EC-MPS, however we believe that robust data are lacking.

Eligibility Criteria:
Inclusion Criteria:

* recipients of liver or kidney or heart or lung or kidney/pancreas transplants
* at least 1 month post solid organ transplant
* on an immunosuppressive regimen which includes MMF in combination with cyclosporine A or tacrolimus
* previous MMF dose reduction of minimum of 25% of total dose due to at least one gastrointestinal complication with MMF therapy
* age of 18-75 years

Exclusion Criteria:

* less than 1 month post transplant
* allergy (hypersensitivity) to MPA, MMF, EC-MPS or to any ingredients of Myfortic or CellCept
* unwillingness or inability to give written consent
* pregnant or nursing women, or women planning to become pregnant
* patients with GI symptoms due to reasons other than related to MMF therapy
* active Post Transplant Lymphoproliferative Disease (PTLD)
* significant or uncontrolled concomitant infections or other serious medical problems
* active bacterial, viral or fungal infection
* inability to self-administer the Quality of Life questionnaires
Addictive Potential of LCCs in Dual Users

This study is about whether or not little cigars and cigarillos cause or maintain addiction, and if flavors, such as fruit, make them more addictive. The purpose of this study is to understand the addiction potential of little cigars and cigarillos compared to cigarettes in young adults who smoke both products. This study will also look at the differences between men and women. In the rest of this form, little cigars or cigarillos will be referred to as LCCs.


Eligibility Criteria:
Inclusion Criteria:

* Current regular dual user of little cigars/cigarillos (LCCs) and cigarettes, defined as: (a) report smoking cigarettes on ≥ 8 of the past 30 days, and (b) report smoking unaltered LCCs (without marijuana) on ≥ 8 of the past 30 days.
* Able to speak, read and understand English
* Age 18-34 years of age
* Stable residence (not planning to move during study period)
* Not intending to quit smoking cigarettes or LCCs within the next 2 weeks
* An expired carbon monoxide (CO) level of at least 4 ppm of expired air to verify smoking status

Exclusion Criteria:

* Pregnant for women (verified by urine pregnancy test at Visits 1 and 2)
* Current use of (or plans to use in the next 2-3 weeks) nicotine replacement products or cessation products (e.g., bupropion) to minimize confounding effects of another product)
* Positive breath alcohol screen (breath alcohol level (BAL) \> 0 g/ml; one re-test allowed; assessed at Visits 1, 2, and 3)
* Illicit drug use other than marijuana (verified by positive drug toxicology test at Visits 1 and 3; one re-test allowed)
* Met criteria for Cannabis Dependence assessed by the Cannabis Use Disorders Identification Test-Revised (CUDIT-R)
Effects of Taichi Exercises on Cardiorespiratory Fittness

Effects of tai chi exercises on cardiorespiratory fitness among scchool going childern. sample size is 30 .divided two groups into 15 15 members one group is giving hand and art crafts activity other is giving tai chi basics level exercises then check and compare cardiorespiratory fitness by time up and go test and 6 minutes walk test. compare the results.

This study will be a randomized controlled trial involving 30 participants, with data collected from the Sanai school system in Sargodha. The study will include school-aged children with normal weight between the ages of 10 and 14. Children with any cardiorespiratory conditions, hemophilia, muscular dystrophy, or a history of cardiovascular events will be excluded. The sample of 30 will be divided into two groups of 15 participants each. Group A will participate in tai chi exercises across three levels, while Group B will engage only in basic arts and crafts activities. The interventions will consist of 10 sessions, conducted at a rate of 5 sessions per week over 2 weeks. To assess the respiratory fitness of the children, data will be collected using the 6-minute walk test and the Timed Up and Go test. Data analysis will be performed using SPSS version 26.0.

Eligibility Criteria:
Inclusion Criteria:

* childerns with 10 to 14 years
* childerns with normal weight less than 30kg/m2

Exclusion Criteria:

* Childerns with any cardiorespiratory issues
* Childerns who have gone through CVA,hemophilia, dystrophy and conditions which impact cardiorespiratory status
NeoSAMBA: Neoadjuvant: Does the Sequence of Anthracycline and Taxane Matters: Before or After?

The purpose of this study is to evaluate the usual and the reverse sequence of an anthracycline followed by a taxane in locally advanced breast cancer.

Anthracylines and taxanes are the most active chemotherapy agents in the treatment of breast cancer. The usual sequence of an anthracycline followed by a taxane is due to the timing of their discovery and introduction in the treatment armamentarium. More recent evidence suggests that there is pre clinical as well as clinical rational for the reverse sequence.

The neoadjuvant approach allows quick evaluation of these different treatment strategies. At the same time, the study will collect tissue biopsies and blood at different time points in order to evaluate predictive biomarkers.

Eligibility Criteria:
Inclusion Criteria:

1. Stage IIB to IIIB HER-2 negative breast cancer
2. ECOG performance status ≤ 2
3. Neuropathy grade \<1 by the Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v 3.0)
4. Adequate hematologic function with:

   * Absolute neutrophil count (ANC) \>1500/μL
   * Platelets ≥100,000/μL
   * Hemoglobin ≥ 9 g/dL
5. Adequate hepatic and renal function with:

   * Serum bilirubin ≤ 1.5 x the institutional upper limit of normal (ULN)
   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 x institutional ULN
   * Alkaline phosphatase ≤2.5 x institutional ULN
   * Serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥ 50 mL/min
6. Adequate cardiac function

   * Left ventricular ejection fraction (LVEF) within institutional normal range
7. Knowledge of the investigational nature of the study and ability to provide consent for study participation

Exclusion criteria

1. Pregnancy
2. Bilateral, synchronous breast cancer
3. Previous diagnosis of breast or other cancer
4. Any other disease(s), psychiatric condition, metabolic dysfunction, that contraindicates the use of study drugs or that would make the patient inappropriate for this study
A Study to Determine the Efficacy, Safety, and Durability of Faricimab in Participants With Neovascular Age-Related Macular Degeneration

This study is a Phase IIIb/IV, multicenter, randomized, two-arm, open-label 100-week study to investigate the efficacy, safety, and durability of intravitreal 6-mg faricimab administered at up to 24-week intervals in patients with neovascular age-related macular degeneration (nAMD) that are treatment-naïve in the study eye.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy as determined by medical evaluation that includes medical history and physical examination
* Agreement to adhere to the contraception requirements described in the protocol

Ocular Inclusion Criteria for Study Eye:

* Active treatment-naïve macular neovascularization (MNV) secondary to age-related macular degeneration (AMD), confirmed by the investigator based on the presence of intraretinal fluid (IRF) or subretinal fluid (SRF) affecting the central subfield on optical coherence tomography (OCT)
* BCVA of 83 to 24 letters, inclusive (20/25 to 20/320 approximate Snellen equivalent, using the early treatment diabetic retinopathy study \[ETDRS\] protocol and addressed at the initial testing distance of 4 meters on Day 1)
* Sufficiently clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis

Exclusion Criteria:

Ocular Exclusion Criteria for Study Eye:

* MNV due to causes other than nAMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis
* Retinal pigment epithelial tear involving the macula on Day 1
* Current vitreous hemorrhage on Day 1
* Prior periocular pharmacological or IVT treatment (including faricimab, anti-vascular endothelial growth factor \[VEGF\], or complement inhibitor medication) for other retinal diseases

Ocular Exclusion Criteria for Fellow (Non-Study) Eye:

* Participants who have a nonfunctioning fellow (non-study) eye, defined as either BCVA of hand motion or worse, or no physical presence of non-study eye (i.e., monocular), at both the screening and study Day 1 visits

Ocular Exclusion for Both Eyes:

* History of idiopathic or autoimmune associated uveitis in either eye
* Active ocular inflammation or suspected or active ocular or periocular infection in either eye on study Day 1
Survey Study and Records Review of Treatment Outcomes in Freeman-Sheldon Syndrome

The purpose of this study is to evaluate the difference in diagnosis accuracy, treatment outcomes, patient perspectives, facial function and walking ability, emotional and social health, and respiratory complications between Freeman-Burian syndrome (formerly, Freeman-Sheldon or whistling face syndrome), Sheldon-Hall syndrome, and distal arthrogryposis types 3, and 1.

The approximate cumulative total time for study-related activities will be 3 hours, including email communication, survey completion, and a medical interview.

The study will involve completing 6 short ½ to 1-page surveys and participating in a medical interview. Participants may be asked to provide medical records for review. All study-related activities will take place remotely, and no travel is required.

According to the only study of patients and a recent study of individual case reports, Freeman-Burian syndrome (FBS) may be over-diagnosed by 33-66%, and it is most often confused with Sheldon-Hall syndrome and distal arthrogryposis (DA) types 3 and 1. Unfortunately, while these conditions are different from FBS, many think of them as being less severe versions of FBS. This is not true. FBS is a skull and face syndrome, while Sheldon-Hall syndrome and DA types 1 and 3 are syndromes of the arms, legs, hands, and feet that (except DA type 1) may have mild face deformities. It is important to understand this difference, FBS does not respond well to treatment. The other syndromes generally do respond well to treatment. To improve diagnosis and treatment, it is important to understand factors contributing to an accurate diagnosis and treatment outcome. To provide better evidence for these being very different syndromes, it also is important to compare the above areas of health between people with all of these syndromes. It is hoped the study will help improve treatment and identify areas for further research.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are able to provide informed consent or have a legally appointed representative who is able to provide informed consent
* Patients who have Freeman-Burian syndrome (formerly, Freeman-Sheldon syndrome), Sheldon-Hall syndrome, distal arthrogryposis type 1, or distal arthrogryposis type 3
* Persons who speak and read English, German, Russian, or Czech

Exclusion Criteria:

* Patients who are not able to provide informed consent or do not have a legally appointed representative who is able to provide informed consent
* Patients who do not have Freeman-Burian syndrome (formerly, Freeman-Sheldon syndrome), Sheldon-Hall syndrome, distal arthrogryposis type 1, or distal arthrogryposis type 3
* Persons who do not speak or read English, German, Russian, or Czech
Inaticabtagene Autoleucel Injection Treatment for Adult Relapsed or Refractory Acute Lymphocytic Leukemia

This clinical trial is a non-interventional, observational, multicenter, post-marketing real-world study to evaluate the efficacy and safety of Inaticabtagene Autoleucel Injection in Chinese adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia.

The study is a non-interventional, observational, multicenter, post-marketing real-world study, and its objective is to evaluate the efficacy and safety of Inaticabtagene Autoleucel Injection in the treatment of Relapsed or Refractory acute lymphoblastic leukemia. The study consists of screening period including leukapheresis, treatment period, and follow-up period (2 years at most).

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years;
2. Diagnosed with relapsed or refractory B-cell acute lymphoblastic leukemia;
3. Patients deemed eligible for receiving commercial Inaticabtagene Autoleucel injection treatment as determined by the investigator;
4. Patients voluntarily participate in this study and sign an informed consent form. For patients lacking full legal capacity, informed consent must be obtained from their legal guardian

Exclusion Criteria:

None
Can Recurrence of Cancer in the Oropharynx Be Detected by Blood Samples?

This study investigates if longitudinal analyses of cell-free HPV-DNA in blood samples can be utilized to detect recurrence in patients diagnosed and treated for HPV-positive oropharyngeal squamous cell carcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed HPV+ (or p16+) OPSCC carcinoma originating from the oropharynx
* Above 18 years of age
* Informed consent
* Patients offered curative treatment.

Exclusion Criteria:

* The patient does not speak or understand Danish
* The patient has another disease/condition considered a reason for exclusion
The Effect of Blood Flow Restriction Applied During Nordic Hamstring Exercise

The aim of this study is to investigate the effects of blood flow restriction applied during nordic hamstring exercise on neuromuscular activation and endothelial function.


Eligibility Criteria:
Inclusion Criteria: Ankle arm index above 0.9

-

Exclusion Criteria:

* Having chronic diseases such as coronary heart disease, kidney diseases, diabetes, uncontrollable hypertension
* Having a history of deep vein thrombosis
* Having a previous hamstring injury
* To smoke
* Having a Body Mass Index over 25
* Having a history of major surgery