cyrilzakka/clinical-trials huggingface dataset:
Dysvascular Amputation Self-Management of Health

The purpose of this study is to determine if walking biobehavioral intervention improves physical activity after dysvascular lower limb amputation.

Sedentary lifestyles and high levels of disability are relevant public and personal health issues resulting from the chronic comorbid condition of dysvascular lower limb amputation. This study examines the use of an evidence-based walking biobehavioral intervention to increase physical activity after dysvascular amputation. The proposed intervention leverages successes in conventional prosthetic rehabilitation, while addressing the complex health conditions and chronic sedentary behaviors that underlie dysvascular amputation, with the ultimate goal of improved physical activity self-management to minimize disability.

Eligibility Criteria:
Inclusion Criteria:

* Within the age range of 50-85 years
* Confirmed diagnosis of Type II Diabetes Mellitus (DM) and/or Peripheral Artery Disease (PAD)
* Transtibial, knee disarticulation, or transfemoral lower-limb amputation (LLA) (or re-amputation) within the past 12 months
* Participant goal of household walking or better using a prosthesis

Exclusion Criteria:

* Trauma or cancer-related etiology of the LLA
* Decisionally challenged individuals (MMSE score below 24)
* Prisoners
* Active cancer treatment
* Recent stroke (within 2 years)
* Clinical discretion of principal investigator to exclude patients who are determined to be unsafe and/or inappropriate to participate in the described intervention.
Effect of Warm Saline Irrigation on Bleeding in Mandibular Third Molar Surgery

The objective of this research is to compare the effect of irrigation during impacted mandibular third molar surgery, with normal saline of 25 ± 2 ° C and 37 ± 1 ° C for control and experimental sides, respectively.

The objective of this research is to compare the effect of irrigation during impacted mandibular third molar surgery, with normal saline of 25 ± 2 ° C and 37 ± 1 ° C for control and experimental sides, respectively. For this purpose, 40 mandibular impacted third molars will be randomly allocated to two groups and surgically removed with the abovementioned saline temperatures. Finally, the suctioned liquids and duration of the surgeries will be carefully measured and compared between both sides.

Eligibility Criteria:
Inclusion criteria

* Being a candidate for bilateral mandibular third molar surgery
* Both mandibular third molars must have a similar inclination to the second molar
* Both mandibular third molars must have same Pell \& Gregory's classification

Exclusion criteria

* Presence of any systemic condition or using any type of medication
* History of allergy to local anesthetic (LA) solutions
* Patients with an active gag reflex
* Pregnant and post-menopause women
* Patients with pericoronitis or any local inflammation
Preliminary Investigation of ViaShield™ Amnion Patch as an Anti-Adhesive Barrier in Hemicraniectomies

The goal of this study is to demonstrate that ViaShield™ amnion patch is effective in preventing fibroblast activity and hence soft tissue adhesions after a hemicraniectomy.

A hemicraniectomy is a surgical procedure in which part of the skull is temporarily removed to relieve pressure on the underlying brain. Hemicraniectomies are typically performed on patients experiencing severe brain injury, usually due to stroke or trauma. In these cases, the brain injury and swelling is so severe that it can lead to brain compression and brain death. As a result, a surgeon will remove the bone flap to help with brain swelling and increased intracranial pressure. After the patient heals, a cranioplasty will be performed to restore the bone flap to its original location.

When the central nervous system is deprived of its normal covering, as is the case with hemicraniectomies, the exposed area becomes the site of cellular reaction from surrounding tissue1 and soft tissue adhesions frequently develop between the skin flap and the dura mater or exposed brain, which may lead to less than optimal clinical outcome.

ViaShield™ is an amnion patch produced from human amniotic membrane. Because of its inherent anti-adhesive properties, amnion serves as an ideal barrier against scarring and soft tissue adhesions to the neural elements, anterior vessels and hardware.

Eligibility Criteria:
Inclusion Criteria:

18 years of age minimum Informed consent signed by patient or next of kin

Exclusion Criteria:

Immunosuppressive disorder
Stem Cell Therapy in Autism Spectrum Disorders

The purpose of this study was to study the effect of stem cell therapy on common symptoms in patients with autism spectrum disorders


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed cases of any type of autism spectrum disorders
* age above 6 months

Exclusion Criteria:

* presence of acute infections such as Human immunodeficiency virus/Hepatitis B Virus/Hepatitis C Virus
* malignancies
* bleeding tendencies
* pneumonia
* renal failure
* severe liver dysfunction
* severe anemia \[Hemoglobin \< 8\]
* any bone marrow disorder
* space occupying lesion in brain
* other acute medical conditions such as respiratory infection and pyrexia
Effect of Carotid Ultrasound-guided Fluid Management on Anesthetic-induced Hypotension in Elderly Patients Undergoing Gastrointestinal Surgery

The goal of this clinical trial is to learn about Whether carotid ultrasound guided fluid management can reduce the incidence of hypotension after general anesthesia induction in elderly patients undergoing gastrointestinal surgery.

The main question\[s\] it aims to answer are:

Whether fluid therapy reduces the incidence of general anaesthesia induced hypotension in elderly patients undergoing gastrointestinal surgery.

Whether carotid ultrasound can guide fluid management in elderly patients undergoing gastrointestinal surgery.

Participants will use carotid ultrasound to assess volume status. If volume is insufficient, fluid therapy will be selected until volume is sufficient, anesthesia will be then induced. If volume is sufficient, anesthesia will be directly induced. There is a comparison group: No carotid ultrasound will be used to assess the volume status of the patients, and anesthesia will be directly induced.


Eligibility Criteria:
Inclusion Criteria:

* Age 60-80 years old
* gender unlimited
* ASA: Grade I-Ⅲ
* BMI:18-30kg/㎡
* Patients undergoing elective gastrointestinal surgery under general anesthesia Informed consent

Exclusion Criteria:

* Carotid artery stenosis ≥50%
* Patients with heart valve disease
* Patients with left ventricular ejection fraction \< 50%
* Patients with cardiac dysfunction (NYHA grade Ⅲ-Ⅳ and/or NTproBNP≥900pg/ml)
* Patients Combined with renal insufficiency (creatinine ≥178μmol/L, and/or blood urea nitrogen \> 9mmol/L)
* Preoperative systolic blood pressure\> 160mmHg or diastolic blood pressure \> 100mmHg
* Refuse to participate in the test
* Patients participating in other clinical trials
Evaluation of Vitrase as an Adjuvant to Increase Absorption and Dispersion of Other Injected Anesthetics

The purpose of this study is to evaluate Vitrase as an adjuvant to increase absorption and dispersion of other injected anesthetics


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for an ophthalmic surgical procedure

Exclusion Criteria:

* Known allergy to bee venom
Comparison of Proton and Carbon Ion Radiotherapy With Advanced Photon Radiotherapy in Skull Base Meningiomas: The PINOCCHIO Trial.

In PINOCCHIO-Triayl, carbon ion radiotherapy is compared to proton and advanced photon radiotherapy in patients with skull base meningiomas. There will be two treatment arms with photons, one arm with hypofractionated photon radiotherapy, and one arm with conventional fractionation. The study is designed as descriptive study on feasibility of the investigated therapies aiming at a comparison of toxicities. The study will serve as a basis for further larger randomized protocols comparing efficacy of the therapies, assuming toxicity is comparable in all four treatment arms. Primary endpoint is toxicity, secondary endpoints are overall survival, progression-free survival and quality of life.


Eligibility Criteria:
Inclusion Criteria

Patients meeting all of the following criteria will be considered for admission to the trial:

* Histologically or imaging confirmed skull base meningioma
* macroscopic tumor - Simpson Grade 4 or 5
* age ≥ 18 years of age
* Karnofsky Performance Score \>=60
* For women with childbearing potential, (and men) adequate contraception (sexual abstinence, estrogen- or gestagen containing contraceptive medication etc.)
* Female participants: No pregnancy present (pregnancy test required)
* Ability of subject to understand character and individual consequences of the clinical trial
* Written informed consent (must be available before enrolment in the trial)

Exclusion criteria:

Patients presenting with any of the following criteria will not be included in the trial:

* refusal of the patients to take part in the study
* previous radiotherapy of the brain
* histologically confirmed atypical or anaplastic meningioma
* optic nerve sheath meningioma (ONSM)
* Patients who have not yet recovered from acute toxicities of prior therapies
* Known carcinoma \< 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
* Pregnant or lactating women
* Participation in another clinical study or observation period of competing trials, respectively.
Research of the Correlation Between Metabolic Syndrome, Retinal Thickness and Visual Acuity

Purpose: To investigate the relationship between retinal thickness (RT) and metabolic risks (MRs) in patients without retinal lesion.

Methods: Fifty-two patients over 60 y/o were divided into four groups according to their MRs of hypertension, hyperlipidemia or hyperglyceremia. After complete ophthalmic examination, optical coherence tomography was performed to measure RT.


Eligibility Criteria:
Inclusion Criteria:

* We enrolled the patients included age more than 60 years old, no positive finding during dilated fundus examination.

Exclusion Criteria:

* The exclusion criteria were as followed:

  * systemic disease that will affect visual acuity evaluation (for example: CVA), \*opaque cornea and vitreous
  * glaucoma
  * uvietis and other clinically established ocular disease.
* According to the LOCS III11, those who had nuclear opalescence, nuclear color more than grade 3 or any grade of cortical cataract and posterior subcapsular cataract were also eliminated.
Double vs Single Intrauterine Insemination in Male Factor Infertility

The aim of the study is to compare the pregnancy outcomes of single vs double intrauterine insemination (IUI) in couples with male factor infertility.

The principle behind double intrauterine insemination in male factor infertility couples is to create a longer time frame for fertilization and to increase motile sperm number in female genital tract in order to increase pregnancy rates. There's a clinical equipoise on the benefits of performing double IUI in couples following ovarian hyperstimulation with daily follicle stimulating hormone injections in male factor subfertility. As it is stated in Cochrane database, there's a need for adequately powered, randomized, high-quality studies on this subject.

In this study, as a result of a-priori power analysis 132 participants in each study arm is planned to be recruited in the study. Male factor infertility included in the study is defined as total motile sperm count (TPMSC) less than 10 million. TPMSC less than 1 million, female age greater than 40, uterine anomaly, no patent tubes shown in hysterosalpingography, history of ovarian surgery and known endometriosis will be excluded. Couples with two basal semen analysis with TPMSC between 1-10 million will be randomized to single or double IUI procedure. To accomplish this in approximately 1 year period, the study is planned as a multi-center study.

The objective of the study is to compare the pregnancy outcomes of single and double intrauterine insemination groups, following ovarian hyperstimulation in couples with male factor subfertility.

Eligibility Criteria:
Inclusion Criteria:

* Couples trying to conceive for at least 6 months despite of regular sexual intercourse
* Female partner between 18-40 years old
* Male partner sperm analysis total motile sperm count between 1-10 million in at least 2 sperm analysis on different days.

Exclusion Criteria:

* No patent fallopian tubes shown in hystero-salpingography
* Female partner with a uterine anomaly
* History of a previous ovarian surgery
* Known or suspected endometriosis in female partner
* Body-mass index (BMI) \> 40 kg/m2
A Phase 1b/2 Study of Serabelisib in Combination With Canagliflozin in Patients With Advanced Solid Tumors

This study aims to test the hypothesis that combining serabelisib, a PI3K alpha isoform inhibitor, with an SGLT2 inhibitor, canagliflozin will improve efficacy in the treatment of patients with advanced solid tumors.

This study aims to test the hypothesis that controlling the glucose/insulin feedback will enhance the efficacy of PI3K inhibition in treating solid tumors. The treatment consists of serabelisib, a PI3K alpha isoform (PI3Kα) inhibitor, combined with the sodium-glucose cotransporter-2 (SGLT2) inhibitor canagliflozin. The study will assess the safety and efficacy of the combination in adult patients with advanced solid tumors harboring mutations that may be dependent on PI3Kα activity: PIK3CA mutations and KRAS mutations.

Eligibility Criteria:
Inclusion Criteria:

1. Have histologically or cytologically confirmed locally advanced or metastatic solid tumors.
2. Have a tumor harboring a mutation in PIK3CA or KRAS genes.
3. Have received prior therapy and have recurrent or persistent disease without standard therapies available, or are ineligible to receive standard therapies.
4. Have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
5. Have Eastern Cooperative Oncology Group performance status (ECOG PS) of ≤2
6. Have adequate organ function.
7. Have adequate birth control during the course of the study.

12. Are able to receive canagliflozin

Exclusion Criteria:

1. Diagnosis of primary brain tumor
2. Untreated brain metastasis or history of leptomeningeal disease
3. Have received prior chemotherapy within 28 days or other anticancer agents within 28 days of 5 half lives (whichever is the shorter duration) before the first administration of study drug. The exception is patients in Cohort 4 (PIK3CA-mutated breast cancer) are allowed to receive ongoing endocrine therapy.
4. Have diabetes mellitus requiring insulin therapy
5. Have diabetes mellitus requiring insulin secretagogue therapy
6. Have poorly controlled diabetes mellitus defined as glycosylated hemoglobin A1c (HbA1c) \>7.5%
7. Have a secondary malignancy requiring therapy or are unstable without therapy.
8. Known impaired cardiac function or clinically significant cardiac disease.
9. Myocardial infarction or unstable angina within 6 months before the first administration of study drug.
10. Pregnant (positive serum pregnancy test) or breastfeeding
Clinical Markers of Dysphagia in Cardiac Surgical Patients

Although dysphagia is a known complication of cardiac surgery, risk factors and sensitive bedside clinical markers of dysphagia have not yet been identified. This longitudinal study will enroll 380 cardiac surgical patients and identify contributing risk factors of incident cases of dysphagia and identify sensitive bedside markers of dysphagia. Statistical modeling will produce two pragmatic clinical tools - a risk prediction model and a beside screening tool to improve care models.

Swallowing impairment and VFMI are common, yet often overlooked, complications of cardiovascular surgical procedures. The true incidence of both dysphagia and VFMI in this patient population is unclear due to a lack of rigorous study using instrumental assessment techniques and validated outcomes in all patients undergoing cardiovascular surgery. The study is therefore aimed to determine the incidence of dysphagia and VFMI in this patient population and to characterize impairment profiles related to swallowing safety and efficiency. In addition, the study is also aimed to assess the relative impact of VFMI and dysphagia on health-related outcomes such as length of hospital stay, pneumonia, sepsis, reintubation, and discharge status. The study will identify risk factors for postoperative dysphagia and VFMI in cardiovascular patients to build a practical electronic risk-stratification tool. The study will also aim to identify sensitive bedside clinical markers of dysphagia in postoperative cardiovascular patients to develop a bedside screening tool. All participants with planned surgeries will undergo two research visits (one preoperatively and one postoperatively) where they will undergo an instrumental swallowing test and complete several patient report outcomes and clinical tests. If they are found to have dysphagia after surgery, they will be offered no-cost follow-up swallow tests at months 1 and 6. For those without planned surgeries, the same course of tests with the exception of the preoperative research visit will be completed. Finally, health-related outcomes will be indexed in enrolled participants to determine the impact of dysphagia.

Eligibility Criteria:
Inclusion Criteria:

* Individuals 18-90 years of age
* Undergoing planned or emergent cardiothoracic surgery via sternotomy and/or extended thoracotomy at the University of Florida Heart and Vascular Hospital
* Not pregnant
* Willing to participate in research exams.

Exclusion Criteria:

* Pregnant women
* Those unwilling to participate in research exams.
Effects of Whole-body Vibration Exercise in Brain Injury Patients With Minimally Conscious State

The purpose of this study is to investigate the effect of the whole body vibration exercise on cortical activity and consciousness Level in brain injury patients with minimally conscious state.

Whole body vibration exercise can provide proper somatosensory stimulation and improve muscle strength and postural control. However, there has not yet been a report on the cortical activity changes induced by whole body vibration exercise in brain injury patients with minimally conscious state.

Patients will be randomly assigned to one of the two groups. One group will go through whole body vibration with exercise and the other will only perform exercise. The primary outcome measurement of this study was cerebral cortex activity based on changes in oxygenated hemoglobin concentration using functional near-infrared spectroscopy. Behavioral assessment were performed using the coma recovery scale-revised and modified ashworth scale.

Eligibility Criteria:
Inclusion Criteria:

* Patients whose consciousness level was assessed as minimally conscious state by traumatic brain injury, stroke, and hypoxic brain injury
* Patients who had more than 3 months after brain injury

Exclusion Criteria:

* Patients under 18 years of age and older patients over 80 years
* Pregnant women
* In cases of uncontrolled internal or external disease
* Patients with severe heart, musculoskeletal problems and disabilities, and those with severe neurological lesions prior to brain injury
* Acute or chronic venous thrombosis or hemorrhage
* Person wearing an implant on the spine
* People with severe osteoporosis
Osteoporotic Precisely Screening Using Chest Radiograph and Artificial Neural Network (OPSCAN)

Artificial Intelligence-assisted Diagnosis and Prognostication in Osteoporosis Using Chest X-ray


Eligibility Criteria:
Inclusion Criteria:

* Patients recieved at least 1 chest X-ray examination in 2022
* More than 66% chest X-ray identified as high risk of osteoporosis by AI-CXR

Exclusion Criteria:

* Patients with history of at least 1 dual energy x-ray absorptiometry (DXA)
* Patients with history of osteoporosis or osteoportic fracture
* Patients recieved prescription anti-osteoporotic treatment (excluding vitamin D or calcium)
* Patients died before 01 Jan 2023
Disparities in Myocardial Infarction Remodeling According to Gender

Following myocardial infarction, female individuals demonstrate a poorer prognosis, characterized by elevated rates of mortality and heart failure. A primary hypothesis suggests unfavorable cardiac remodeling in women. This remodeling, defined as alterations in cardiac size and shape post-infarction, necessitates repeated non-invasive imaging for study.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* First myocardial infarction with ST-segment elevation during the hospital phase
* Coronary angiography performed within 72 hours of the infarction
* Inclusion in the RIMA registry
* Patient affiliated or beneficiary of a social security scheme; Signature of informed consent

Exclusion Criteria:

* Patients already enrolled in the study
* Poor understanding of the French language
* Pregnant, breastfeeding, or postpartum women
* Individuals deprived of liberty by judicial or administrative decision; Individuals receiving psychiatric care under coercion
* Individuals subject to a legal protection measure; Individuals incapable of giving consent
High-Dose Multivitamins Compared to a Placebo in Preventing the Recurrence of Cancer in Patients With Early Stage Bladder Cancer

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of high-dose multivitamins may be an effective way to prevent the recurrence of early stage bladder cancer. It is not yet known whether high-dose vitamins are more effective than no further therapy in decreasing the risk of early-stage bladder cancer.

PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of high-dose multivitamins with a placebo in preventing the recurrence of cancer in patients with early stage bladder cancer.

OBJECTIVE: I. Determine whether high dose multivitamins have chemopreventive efficacy beyond standard therapy in reducing the risk of recurrence in patients with resected stage 0 and I (Ta, T1, and Tis) transitional cell carcinoma of the bladder.

OUTLINE: This is a randomized, double blind study. Patients are randomized to receive multivitamins or placebo orally once daily for 3 years. Patients are followed every 3 months for 2 years, then every 6 months for 1 year, and then annually thereafter.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed stage 0 and I (Ta, T1 or Tis) resected transitional cell carcinoma of the bladder No advanced disease or muscle invasion No history of transitional cell carcinoma of the prostate

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Greater than 3 years Hematopoietic: WBC at least 3500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 10 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN SGOT no greater than 3 times ULN Renal: Creatinine no greater than 1.5 times ULN Other: Not pregnant or nursing Fertile patients must use effective contraception At least 5 years since prior malignancy except nonmetastatic squamous cell or basal cell carcinoma of the skin No history of drug interactions which could affect therapy No immunodeficiency

PRIOR CONCURRENT THERAPY: Biologic therapy: Prior intravesical BCG required (if T1 or Tis pathology and negative cytology PAB) Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the pelvis Surgery: Not specified Other: Intravesical therapy within 30 days allowed At least 30 days since greater than 2 multivitamins daily