cyrilzakka/clinical-trials huggingface dataset:
Biomarkers and Validation of Selected Outcome Measures (CMTNSmod)

CMT is a rare disease for which novel treatments are being developed. Evaluation of intervention efficacy is hampered by slow progression and lack of sensitive outcome measures. Primary goal of the project is to identify and validate RNA and protein derived biomarkers in blood of CMT patients for selected outcome measures over 2 years. The investigators expect to develop more responsive outcome measures and circulating biomarkers to improve assessment of intervention efficacy in forthcoming therapeutic trials.

Novel treatments are being developed for CMT. Intervention efficacy evaluation is hampered by slow disease progression and lack of sensitive outcome measures. The investigators have previously shown that biomarkers from skin identified in a CMT1A rat model can be translated to CMT1A patients. Primary goal is to identify circulating biomarkers correlating with disease severity and progression. 210 young, adolescent and adult patients affected by genetically confirmed CMT1A, will be evaluated with different clinical outcome measures, assessing impairment, disability and quality of life: Patients will be re-evaluated at 12 (n=147) and 24 months (n=103) with the same measures to assess disease progression. A number of candidate markers correlating with disease severity have been identified in blood samples from the rat model of CMT1A. At 0-12-24 months a blood sample will be drawn from affected CMT1A patients. The investigators will purify total mRNA from blood samples, and validate the 10 strongest regulated markers identified in the rat model via qRTPCR in blood of CMT1A patients. Protein biomarkers will also be analysed. Marker expression at baseline and at follow up will be correlated with clinical severity and progression. In this translational project (rat/human) the investogators expect to develop more responsive outcome measures and circulating biomarkers to improve assessment of intervention efficacy in forthcoming therapeutic trials.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of CMT1A
* Genetic confirmation of PMP22 duplication (for adults patients)
* Children aged 3-11, adolescents aged 12-17 and adults aged 18-65 years
* Signed informed patient consent

Exclusion Criteria:

* Other causes of neurological and psychiatric disorders
* Severe internistic disease
* Patient known or suspected to be alcohol / drug abuser
* Pregnancy, breast feeding period
* Permanent Vitamin C intake
* Participation an interventional clinical study up to 4 weeks prior to inclusion
Feasibility of a Modular mHealth for Tailored Rehabilitation of Breast Cancer

This study investigated the feasibility of the novel modular mobile health (mHealth) for personalized rehabilitation and explored the participants' satisfaction and app data during treatment of breast cancer.

This is prospective, feasible, parallel study in post-operative patients with breast cancer and during treatment. Disability of Arm, Shoulder, Hands (DASH), Physical activity data (IPAQ-SF), Physical measurement such as hand grip strength, body mass index (BMI), muscle mass, and differences in arm circumference, PRO-CTCAE, Distress Thermometer, needs and satisfaction in app, personal health record of app (exercise, daily step count, etc.) Measure will be evaluated on 1-month, 2-month, 4-month, 6-month, 9-month, and 12-month after POD.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral breast cancer at TNM stage 0 \~ III
* Patients who will undergo the treatment (chemotherapy, radiation therapy, and hormone therapy) after surgery
* Patients who had a mobile phone (Android or iOS)

Exclusion Criteria:

- Patients who have metastases or recurrence to other organs were excluded
Neurocognitive and Neuroimaging Outcomes in Older Patients With Multiple Myeloma Treated With Autologous Stem Cell Transplantation

The purpose of this study is to learn about possible changes in thinking (cognitive) abilities, such as memory skills, and in brain anatomy and function, in adults with multiple myeloma who are treated with high-dose chemotherapy followed by ASCT.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with multiple myeloma and in complete, partial or very good partial remission at enrollment as per standard International Myeloma Working Group Criteria
* Scheduled to have high-dose chemotherapy and ASCT
* Age 60 - 75 years at study entry
* In the judgment of the consenting professional, fluent and able to communicate well enough in English to complete the study assessments and provide informed consent.

  * Patients who report that English is not their primary language will be asked the US Census English proficiency question "How well do you speak English" and the answer "very well" will be required

Exclusion Criteria:

* With signs and/or symptoms of central nervous system cancers (e.g., tumors, metastases, leptomeningial disease) as determined by their physician, medical records, or by a brain MRI, either at the time of enrollment or during the study period
* With current diagnosis of major Axis I psychiatric disorder (DSM-IV), major depression, bipolar disorder, or schizophrenia, as per medical records or patient report
* As per patient report or as confirmed by the medical record, if the patient is taking anti-depression or anti-anxiety medication, \< 2 months on these medications or a change in the prescribed dose in the past 2 months
* With history of a neurological disorder, neurodegenerative disease, or traumatic brain injury with loss of consciousness (\>60 minutes), as per medical records or patient report
* With a history of another cancer, except for non-melanoma skin cancer, as per medical records or patient report
* With current substance abuse and/or history of substance abuse, as per medical records or patient report
* With evidence of visual or auditory impairment that would preclude completion of the assessments, as per medical records or patient report
* With contraindications to MRI examinations as per standard screening guidelines used in the Department of Radiology (i.e., ferromagnetic material or implants, pacemakers or defibrillators, stents, claustrophobia)
Glaucoma HFA / OCT Specificity Study

Study consists of five visits over a one to three month time period.

Each visit consists of optical coherence tomography (OCT) scanning (4 scans ) and two HFA (Humphrey Field Analyzer) visual fields of the study eye only.

Eligibility Criteria:
Inclusion Criteria:

* Adult males or females 40 to 80 years old
* Able and willing to attend the required study visits
* Able and willing to provide consent and follow study instructions in English
* A diagnosis by the Principal Investigator or co-investigator of glaucoma, pre-perimetric glaucoma or glaucoma suspect
* Subjects must have experience in threshold automated perimetry, having performed a previous SITA (Swedish Interactive Thresholding Algorithm) threshold test within one year of enrolling to the study
* Ability to fixate that allows obtaining acceptable visual fields and OCT scans in the study eye

Exclusion Criteria:

* • Best-corrected visual acuity less than 20/40 (study eye only) on a Snellen chart or on a Snellen equivalent acuity chart

  * Spherical refraction outside -12.00 to +5.00 diopters (D) or cylinder correction outside 3.00 D (study eye only)
  * Amblyopia (either eye)
  * Narrow irido-corneal angles or a diagnosis of narrow angle glaucoma
  * Previous or current eye disease in the study eye, serious eye trauma or intraocular surgery (except cataracts with lens implants), or the presence of ocular findings that could affect the visual field, other than glaucoma
  * Cataract surgery in the study eye within six (6) months of first visit
  * Dx of any optic neuropathy other than glaucoma
  * Vitreoretinal traction or epiretinal membrane in the study eye
  * Diagnosis or history of any systemic disease / condition / treatment which is likely to affect the visual field outcome in the Study Eye other than glaucoma
  * History of diabetes, leukemia, AIDS, uncontrolled systemic high blood pressure, dementia or multiple sclerosis
  * Any disease that is likely to progress within the 3 month time period that might have visual field implications
  * A life threatening or debilitating disease
  * Participation in any study involving a non-FDA approved investigational drug (IND) within the past month, or ongoing participation in a study with a non-FDA approved or cleared investigational device (IDE)
  * Concomitant use of hydrochloroquine and/or chloroquine
A Study of Atezolizumab in Combination With Carboplatin Plus (+) Nab-Paclitaxel Compared With Carboplatin+Nab-Paclitaxel in Participants With Stage IV Non-Squamous Non-Small Cell Lung Cancer (NSCLC)

This randomized Phase III, multicenter, open-label study designed to evaluate the safety and efficacy of atezolizumab (an engineered anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with carboplatin+nab-paclitaxel compared with treatment with carboplatin+nab-paclitaxel in chemotherapy-naive participants with Stage IV non-squamous NSCLC. Participants were randomized in a 2:1 ratio to Arm A (Atezolizumab+Nab-Paclitaxel+Carboplatin) or Arm B (Nab-Paclitaxel+Carboplatin).


Eligibility Criteria:
Inclusion Criteria:

* Eastern Cooperative Oncology Group performance status of 0 or 1
* Histologically or cytologically confirmed, Stage IV non-squamous NSCLC
* Participants with no prior treatment for Stage IV non-squamous NSCLC
* Previously obtained archival tumor tissue or tissue obtained from fresh biopsy at screening
* Measurable disease, as defined by RECIST v1.1
* Adequate hematologic and end organ function

Exclusion Criteria:

Cancer-Specific Exclusions:

* Active or untreated central nervous system metastases
* Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome

General Medical Exclusions:

* Pregnant or lactating women
* History of autoimmune disease
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted
* Positive test for human immunodeficiency virus
* Active hepatitis B or hepatitis C
* Severe infection within 4 weeks prior to randomization
* Significant cardiovascular disease
* Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures

Exclusion Criteria Related to Medications:

* Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies
Searching for the Liver Cancer-Related Biomarkers

Hepatocellular carcinoma (HCC) has been the leading cause of cancer death in Taiwan. About 6000-8000 people died of this cancer every year in Taiwan. Though regular sonographic examination can early detect small HCC and there are many therapeutic modalities for HCC, the therapeutic results remains unsatisfactory. Though Alpha-fetoprotein (AFP) and des-γ-carboxy prothrombin (DCP) are used as the tumor markers for diagnosis of HCCs, these two markers are not good enough for the early detection of small HCCs. To improve the survival, further investigations of the early diagnostic markers are still needed. In this current project, we applied the proteomic method to identify the HCC biomarkers.

Cell lines Hep3B and Huh7 HCC cell lines will be cultured in (Dulbecco's modified Eagle medium) DMEM containing 10% fetal calf serum and incubated at 37 C in 5% CO2 incubator. The rationale of using HCC cell line instead of clinical HCC samples is that HCC tissues are heterogeneous and might contain some non-HCC cells. The cell will be harvested when cells reach 95% confluence.

Sera collection 20 mL of venous 20 mL of venous blood was collected from 20 HBV-related HCC and 20 HCV-related HCC patients before treatment. The venous blood was allowed to clot, centrifuged at 800 g for 5 min, and serum was aliquoted and stored at -80 0C. Control sera were obtained from 20 HBV carriers without HCC, 20 chronic hepatitis C patients without HCC, and 10 normal subjects without liver diseases.

Two-dimensional gel electrophoresis using patients' sera for immunoblotting will be done. Spots of interest will be identified by delayed extraction matrix-assisted laser desorption ionization.

Eligibility Criteria:
Inclusion Criteria:

* hepatocellular carcinoma

Exclusion Criteria:

* multiple cancers
Effect of Neuromuscular Electrical Stimulation in Patients With Chronic Low Back Pain

This study evaluates the effect of a 10-week long intervention with the StimaWELL 120MTRS system on multifidus morphology and function in individuals with chronic low back pain. Half the participants will receive muscle therapy at the device's phasic setting, while half will receive muscle therapy at the device's combined setting. This study also evaluates the acute effect of a single treatment with the StimaWELL 120MTRS on multifidus stiffness in individuals with chronic low back pain.


Eligibility Criteria:
Inclusion Criteria:

* Chronic non-specific LBP (\>3 months), defined as pain in the region between the lower ribs and gluteal folds, with or without leg pain.
* Aged between 18 to 60 years old.
* English or French speakers
* At least a 4/10 score on an 11-point Numerical Pain Rating Scale (NPRS) for pain intensity.

The score will be the average of current pain, and best and worst pain over the previous week.

* At least a 'moderate' Modified Oswestry Disability Index (ODI) score.
* Able to undergo MRI exam.

Exclusion Criteria:

* Currently undergoing or having received physical therapy treatment in the previous month
* Consistent motor control training for the low back and / or consistent weightlifting, power-lifting, bodybuilding, or strongman training in the previous 6 weeks
* History of lumbar surgery
* Presence of positive lumbosacral dermatomes or myotomes
* Presence of disease which could affect the stiffness of muscle tissue (collagen tissue disease, hemiplegia, multiple sclerosis, blood clots)
* Presence of systemic disease (cancer, metabolic syndrome)
* Presence of rheumatoid arthritis
* Presence of spinal stenosis, fracture, infection, or tumor
* Presence of lumbar scoliosis greater than 10 degrees
* Presence of cardiac arrhythmia
* Pregnant and breastfeeding women
* Individuals with epilepsy
* Individuals at risk for serious bleeding
* Individuals with pacemakers or metal implants
* Individuals with aneurysms or heart valve clips
* Individuals with tattoos or piercings in the lumbar spine
* Individuals who have taken prescribed muscle relaxants more than once a week over the past month
* BMI \> 30
The Impact of Intermittent Nutritional Tube Supplementation in Elderly Patients With Dysphagia

This is a prospective, randomized controlled clinical trail involved Elderly Patients With Dysphagia.The goal of this clinical trial is to compare the clinical effect of Intermittent Oro-esophageal Tube Feeding in Elderly Patients With Dysphagia. The main questions it aims to answer:

Can Intermittent Nutritional Tube Supplementation help improve the nutritional status in Elderly Patients With Dysphagia.

Participants will be divided into two groups randomly. All patients are given routine rehabilitation and the intervention group is given Intermittent Oro-esophageal Tube Feeding once a day.

The current situation of dysphagia in elderly individuals is characterized by difficulty or discomfort in swallowing. This condition can occur due to various factors such as muscle weakness, neurological disorders, or structural abnormalities in the throat or esophagus. Dysphagia can lead to complications such as malnutrition, dehydration, aspiration pneumonia, and reduced quality of life. It is important for healthcare professionals to assess and manage dysphagia in elderly patients to ensure proper nutrition and prevent potential health risks.

This is a prospective, randomized controlled clinical trail involved Elderly Patients With Dysphagia.The goal of this clinical trial is to compare the clinical effect of Intermittent Oro-esophageal Tube Feeding in Elderly Patients With Dysphagia. The main questions it aims to answer:

Can Intermittent Nutritional Tube Supplementation help improve the nutritional status in Elderly Patients With Dysphagia.

Participants will be divided into two groups randomly. All patients are given routine rehabilitation and the intervention group is given Intermittent Oro-esophageal Tube Feeding once a day.

Eligibility Criteria:
Inclusion Criteria:

* Age\>60 years.
* Dysphagia confirmed by Videofluoroscopic Swallowing Study.
* Clear consciousness.
* Stable vital signs.

Exclusion Criteria:

* Complicated with severe liver and kidney failure, tumors, or hematological disorders.
* Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
Hypertension and Controlled Hypotension in the Elderly

Comparision of Exposed Factors of Preoperative Hypertension and Intraoperative Controlled Hypotension on Postoperative Delirium in the Elderly under Radical Resection of Head, Neck and Maxillofacial Tumor

Postoperative delirium has a higher incidence in elderly patients after general anesthesia，and It is closely related to the type of surgery, the length of surgery, and the patient's physique.Because head and neck maxillofacial radical surgery requires free flap transplantation and longer duration,and hemorrhage is more when the primary focus is removed，Intraoperative blood pressure reduction is needed to reduce bleeding，therefore, hypoperfusion of craniocerebral blood flow will occur.Low cerebral perfusion is closely related to the occurrence of postoperative delirium.Patients undergoing this type of surgery have more preoperative complications，hypertension is particularly common.Therefore, this study mainly studied the correlation between the preoperative blood pressure level and the controlled hypotension level in patients with radical head and neck and maxillofacial tumors and the incidence of postoperative delirium.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who underwent radical anesthesia for oral and maxillofacial malignant tumors in our hospital
2. ASA grade is Ⅰ-Ⅱ
3. Patient is older than 60 years

Exclusion Criteria:

1. The patient has mental and mental disorders (eg schizophrenia, Alzheimer's disease)
2. There was severe anemia before operation (Hb\<80g/L)
3. Patients had cerebral vascular complications such as cerebral infarction and lacunar infarction before operation
4. Patients who do not cooperate with this trial
5. Long-term use of sedative drugs or analgesics
Frequency of Patho-morphological Classes of Gall Stones in Lahore, Pakistan

It is a cross sectional study in which we are tying to determine frequency of type of gall stones in our setup(Lahore, Pakistan).


Eligibility Criteria:
Inclusion Criteria:

1. Patients with any sex age 1
2. 5 years and above
3. presenting to OPD with cholelithiasis -

Exclusion Criteria:

1. patients who develop gallstones after bariatric surgery
2. less than 15 years of age
Prediction of Cerebral Hyperperfusion Syndrome After Carotid Revascularization Using Deep Learning

Cerebral hyperperfusion syndrome (CHS) was initially described as a clinical syndrome following carotid endarterectomy (CEA), but it may present in both CEA and carotid artery stenting, and is characterised by throbbing ipsilateral frontotemporal or periorbital headache, and sometimes diffuse headache, eye and face pain, vomiting, confusion, macular oedema, and visual disturbances, focal motor seizures with frequent secondary generalisation, focal neurological deficits, and intracerebral or subarachnoid haemorrhage.

Knowledge of CHS among physicians is limited. Most studies report incidences of CHS of 1-3% after carotid endarterectomy. CHS is most common in patients with increases of more than 100% in perfusion compared with baseline after carotid revascularization procedures and is rare in patients with increases in perfusion less than 100% compared with baseline.

The pathophysiological mechanism of CHS remains only partially understood. The chronic lowflow state induced by severe carotid disease results in a compensatory dilation of cerebral vessels distal to the stenosis, as part of the normal autoregulatory response, to maintain adequate cerebral blood flow (CBF). In this chronically dilated state, the vessels lose their ability to autoregulate vascular resistance in response to changes in blood pressure. In fact, it has been shown that this dysautoregulation is proportional to the duration and severity of chronic hypoperfusion. After revascularization and reperfusion, the impaired cerebral autoregulation could then contribute to a cascade of intracranial microcirculatory changes, as explained above, with an inability of reaction toward the augmentation of the CBF after the carotid recanalization.

Although most patients have mild symptoms and signs, progression to severe and life-threatening symptoms can occur if CHS is not recognised and treated adequately. Because CHS is a diagnosis based on several non-specific signs and symptoms, patients may be misdiagnosed as having one of the better-known causes of perioperative complications like thromboembolism.


Eligibility Criteria:
Inclusion Criteria:

1. Age from 30 to 80 years
2. Has a symptomatic (more than 60%) or a asymptomatic (more than 70%) carotid stenosis
3. Permanent residence in the Republic of Belarus

Exclusion Criteria:

1. Patient's unwillingness to continue participating in the study
2. Absence of a temporal window for transcranial dopplerography