cyrilzakka/clinical-trials huggingface dataset:
Cardiovascular Response to Isometric BFR Exercise

The goal of this interventional study is to evaluate the acute impact of isometric blood flow restriction (BFR) exercise on blood pressure and other cardiovascular functions in healthy young adult volunteers. The main question it aims to answer is:

The investigators hypothesize that isometric BFR exercise with a wide-rigid cuff would lead to greater blood pressure and other cardiovascular responses and that these cardiovascular responses would be greater under isometric BFR exercise with narrow-elastic bands compared with the control condition (no cuff).

Participants will perform isometric exercises in 3 laboratory visits with different exercise conditions) no cuff control 2) BFR with wide-rigid cuff 3) BFR with narrow-elastic band.


Eligibility Criteria:
Inclusion Criteria:

- Apparently healthy young adults aged between 18 - 40 years old and signed the informed consent.

Exclusion Criteria:

* Abnormal clotting times
* Acid-base imbalance/acidosis
* Arterial calcification
* Atherosclerotic vessels
* Cardiopulmonary conditions
* Diabetes
* Dialysis/central venous access
* General/local infection
* High intracranial pressure
* Hip, pelvis, or femur fracture
* History of venous thromboembolism
* Hypertension
* Immobility for greater than 48 hours in the past month
* Immobilizing cast
* Implanted medical device
* Lymphectomies
* Obesity
* Open fracture
* Open or unhealed soft tissue injuries
* Paralysis
* Peripheral vascular disease
* Pregnancy/postpartum
* Prior revascularization
* Renal compromise
* Severe crush injuries
* Sickle cell trait/anemia
* Skin grafts
* Stroke
* Temporary nerve damage
* Thrombophilia
* Tumor/cancer
* Varicose veins
* Vascular grafting
Chemotherapy With Raltitrexed and Fluorouracil in Treating Patients With Advanced Colorectal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of raltitrexed and fluorouracil in treating patients who have colorectal cancer that is metastatic, recurrent, or cannot be surgically removed.

OBJECTIVES: I. Determine the maximum tolerated dose of raltitrexed when administered with fluorouracil in patients with advanced colorectal carcinoma. II. Determine the toxicity and safety of this regimen in these patients. III. Assess, in a preliminary manner, the antitumor activity of this regimen in these patients.

OUTLINE: This is a dose-escalation study of raltitrexed. Patients receive raltitrexed IV over 15 minutes followed 24 hours later by fluorouracil IV. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of raltitrexed until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose immediately preceding that at which 2 of 6 patients experience dose-limiting toxicity. An additional 6-10 patients are treated at the MTD. Patients are followed for 6 weeks.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 5-20 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven metastatic, locally recurrent, or surgically unresectable colorectal carcinoma Measurable disease No CNS metastasis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-2 Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT no greater than 2.5 times normal (5 times normal if known liver metastases) Renal: Creatinine no greater than 1.5 mg/dL Other: No severe concurrent infection Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No more than 1 prior chemotherapy regimen Prior fluorouracil-based regimen for advanced colorectal cancer allowed Prior fluorouracil with radiotherapy not considered therapy for advanced disease At least 4 weeks since prior chemotherapy (8 weeks for mitomycin or nitrosoureas) and recovered Endocrine therapy: No concurrent steroids except for antiemesis or as replacement therapy Radiotherapy: See Chemotherapy No prior radiotherapy to more than 30% of bone marrow Surgery: See Disease Characteristics At least 4 weeks since prior surgery unless fully recovered Other: No concurrent vitamin supplements containing folic acid No other concurrent anticancer therapy
Long Latency Auditory Evoked Potentials (P300) Outcomes in Patients With Unilateral Cochlear Implants

Bilateral severe to profound hearing loss is a socially disabling handicap. Cochlear implants can be used to improve hearing in cases where conventional hearing aids are not effective. There are few studies about the long latency Auditory Evoked Potential (P300), in individuals with hearing loss and Cochlear Implant (CI) users. The aim of this project is to study the behavior of P300 in users of unilateral CI.

Bilateral severe to profound hearing loss is a socially disabling handicap. Cochlear implants can be used to improve hearing in cases where conventional hearing aids are not effective. There are few studies about the long latency Auditory Evoked Potential (P300), in individuals with hearing loss and Cochlear Implant (CI) users. The aim of this project is to study the behavior of P300 in users of unilateral CI. Twenty patients with bilateral severe and/or profound post-lingual deafness, all submitted to CI surgery, will be evaluated. Patients will be evaluated through P300 testing on the day before CI surgery, on the day of device activation and 6 months after device use. It is hoped that this study can contribute to the understanding of the mechanisms of brain plasticity involved in the recovery of hearing function after CI surgery. There are few studies on the behavior of P300 in CI users and there are no studies showing how central stimulation occurs after device implantation, during the phases of pre CI, CI activation and 6 months after CI.

Eligibility Criteria:
Inclusion Criteria:

* Patients with post-lingual hearing loss undergoing cochlear implant surgery

Exclusion Criteria:

* Prelingual hearing loss
Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of SKI2670

In this Phase I study, the primary objective is to investigate the safety and tolerability of SKI2670 after oral administration in healthy female subjects. And secondary objective is to investigate the pharmacokinetics and pharmacodynamics of SKI2670 after oral administration in healthy female subjects.

In this Phase I study, the primary objective is to investigate the safety and tolerability of SKI2670 after oral administration in healthy female subjects.

Secondary objective is to investigate the pharmacokinetics and pharmacodynamics of SKI2670 after oral administration in healthy female subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Female, 20 years of age and older
2. Weight between 40kg\~70kg
3. Women who agreed using double contraception method and spermicide, avoiding breast-feeding for at least 30days after IP(investigational product) dosing
4. A history of regular menstrual cycles (cycle: 28±7day, duration: 2\~7day) for at least 2 years and a positive ovulation test between day 11 and 21 in the preceding menstrual cycle of IP(investigational product) dosing

Exclusion Criteria:

1. Women who are pregnant or serum/urine hCG(human chorionic gonadotropin) positive or breast-feeding
2. A history of breast cancer, genital cancer or any estrogen dependent tumor
3. Specified or unspecified diagnosed infertility or history of natural abortion over three times
4. A history of taking other Investigational product within 60days before screening visit or taking ETC drug(Ethical drugs), oriental medicine or OTC drugs(Over-the-Counter drugs) within 14days before screening visit
5. Clinically significant Gynecological disease identified by ultrasonography including estrogen dependent tumor or lesion, sever inflammation or synechia
6. AST(Aspartate aminotransferase), ALT(Alanine aminotransferase) ≥ 2.5 times the upper limit of normal
7. QTc \> 450ms on electrocardiogram result
Left Atrial Appendage Closure Compared to Standard Antiplatelet Therapy in Patients With AF Who Underwent PCI

The objective of Left atrial appendage closure compared to standard antiplatelet therapy in patients with AF who underwent percutaneous coronary intervention (LLA-PCI) study is to evaluate the safety and efficacy of implantation of left atrial appendage closure compared to standard antiplatelet therapy for prevention of thromboembolic events and stent thrombosis in subjects with AF who underwent PCI.

This will be prospective randomized (1:1) open label pilot study. Patients with unstable angina and non-ST-elevation ACS and history of AF will be included in this study. After PCI and DES implantation TEE will be performed for assessing LAA anatomy and size eligible for left atrial appendage closure device implantation. After screening all patients will be randomized in two groups. The first (control) group will receive standard antiplatelet and anticoagulation therapy according to the guidelines (2), the second group of patients will undergo left atrial appendage closure device implantation. After the PCI the first group will take Triple therapy (warfarin + clopidogrel+aspirin) during 45 days and after combination of warfarin+clopidogrel to 6 months after procedure and then only warfarin. The second group will take Triple therapy (warfarin+clopidogrel+aspirin) during 45 days following PCI and after control TEE, warfarin will be discontinued. Then patients from the second group will take DAPT combination (clopidogrel+aspirin) to 6 months after procedure and then only aspirin. Patients will be followed at 45 day, and every 3 months during 12 months of follow up (Figure 1). At each follow-up visits the data regarding clinical events and healthcare utilization will be collected.

Eligibility Criteria:
Inclusion criteria:

* age \> 18 years old
* Acute coronary syndrome without ST elevation and unstable angina 2 weeks before enrolment
* Successful PCI procedure with DES
* History of atrial fibrillation (paroxysmal, persistent or permanent) with ECG documentation within previous 12 month
* CHA2DS2-VASC ≥ 2
* HAS-BLED ≥ 3
* LAA eligible for left atrial appendage closure device implantation (TEE data)

Exclusion criteria:

* age \<18 or \>80 years old
* INR \>3
* recurrent myocardial infarction
* myocardial infarction with ST elevation
* EF\<50%
* severe comorbidities
* Cardiogenic shock (within 72 hours of randomization), as defined by the need for intraaortic balloon support or the requirement for intravenous inotropic support.
* anemia \< 100 g/l
* uncontrolled hypertension
* thrombocytopenia
* oncology
* obesity, BMI\>40
* LAA thrombosis
* Women of childbearing potential (unless post-menopausal or surgically sterile)
Effect of Food-derived Active Components on Digestive Tract Health in Adults with Irritable Bowel Syndrome

The goal of this clinical trial is to learn if Bifidobacterium. animalis subsp.

Lactis A6 Strain or resveratrol to improve the symptoms of diarrhea-predominate irritable bowel syndromes (IBS-D). The main questions it aims to answer are:

1. Does Bifidobacterium animalis subsp.Lactis A6 Strain or resveratrol improve the symptoms of IBS-D.
2. What is the optimal intervention dose of Bifidobacterium. animalis subsp.Lactis A6 Strain or resveratrol to improve IBS-D

Researchers will compare Bifidobacterium. animalis subsp.Lactis A6 Strain or resveratrol interventions to placebo (one look-alike sunbstance that contains no interventions substance) to see if Bifidobacterium. animalis subsp.Lactis A6 Strain or resveratrol relief the symptoms of patients with IBS-D.

Participants will:

1. Take Bifidobacterium. animalis subsp.Lactis A6 Strain or resveratrol every day for 30 days.
2. Visit the clinic once every 15 days for checkups and tests.

We recruited patients with IBS-D. The subjects who met the inclusion criteria were randomly divided into placebo control group, Bifidobacterium. animalis subsp.Lactis A6 Strain group and resveratrol intervention. The intervention period lasted for 4 weeks, and the follow-up was conducted every 15 days. The main outcomes were: ① IBS Symptom Severity Scale (IBS-SSS), ② gut microbiota and their metabolites. The secondary outcomes were: ① IBS Quality of Life score (IBS-QOL), ② Bristol fecal traits score, ③hydrogen breath test; ④ Inflammatory markers. After the intervention, statistical analysis was performed on the experimental data to analyze and compare the differences in the main and secondary outcome indicators of the experimental groups, so as to clarify the intervention effect and effective intervention dose of probiotics and resveratrol on diarrheal IBS, and provide scientific basis for the formulation of relevant clinical treatment paths.

Eligibility Criteria:
Inclusion Criteria:

* met the Western Medicine Rome IV diagnostic criteria for diarrheal IBS
* 18 and 60 years old
* subjects voluntarily sign informed consent forms.

Exclusion Criteria:

* Having a disease that may affect the gut microbiome (e.g., inflammatory bowel disease, celiac disease, diabetes)
* Abdominal pain or diarrhea due to organic disease
* Patients with abdominal surgery
* Patients with serious mental illness and complications of heart, brain, liver, kidney and other systems
* Unable to communicate normally or skilled in the use of communication equipment
* Having serious mental problems or taking related drugs
* Drug or alcohol abusers
* People with special diets (such as vegetarians) or eating disorders or are receiving therapeutic dietary interventions
* Had used antibiotics, probiotics, other drugs that may affect the study
* Participants who are participating in other clinical trials
* Pregnant or lactating women
Difference of Tear Ferning Between Women with and Without Menopausal.

Application of tear ferning test for clinical dry eye diagnosis and menopause

Analyzing the difference in tear ferning structure between women pre and post-menopause with and without hormone replacement therapy (HRT). Tear and blood samples were collected for a menopause-related Enzyme-linked immunosorbent assay. Tear volume, tear osmolarity, intraocular pressure, and tear break-up time were also measured for comparison.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 20 and 65 years

Exclusion Criteria:

* No evident ocular diseases such as cornea, cataracts, vitreous degeneration, glaucoma, and retinopathy.
* Belong to vulnerable groups(pregnancy woman, prisoner, ethical minorities, economic or educationally disadvantaged subjects, disabled individuals such as those at terminal stage of tumorigenesis, blindness, terminal ill individuals)
Electrical Stimulation and Expression of VEGF, VEGFR-2, HIF and NO in the Diabetic Foot Ulcer

The purpose of this study is to determine whether electrical stimulation is effective in the expression of VEGF, VEGFR-2, HIF-1α and NO and healing in diabetic foot ulcer.

30 type 2 diabetic patients with ischemic foot ulceration were enrolled. Patients were randomly assigned to electrical stimulation (ES, n=15) or sham ES (placebo, n=15) groups. ES group received cathodal direct current for 1 h/day, 3 days/week, for 4 weeks (12 sessions). Wound fluid sample was collected for VEGF, VEGFR-2, HIF-1α and NO measurement in the first and last treatment sessions before and after intervention. Wound surface area (WSA) was measured at 1st, 6th, and 12th session.

Eligibility Criteria:
Inclusion Criteria:

* Ischemic diabetic foot ulcer
* Wagner classification DFU 2
* 0.5\<ABI\<0.9
* Mild to moderate diabetic neuropathy

Exclusion Criteria:

* Fracture in a lower limb
* A severe infection
* A malignancy
* Kidney failure
* Skin diseases
* Osteomyelitis
* Pregnancy
Detection and Automatic Segmentation of Liver Nodules in Patients With Colorectal Adenocarcinoma

Evaluation of the diagnostic performance of artificial intelligence-based software for the detection of liver nodules on scanner in patients at risk of liver metastases of colorectal cancer

The aim of this study is to evaluate the performance of a software for liver nodule detection in patients with colorectal cancer compared to the consensus of two radiologists analysis.

300 hepatic scanners will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* Patients consecutively treated for colorectal cancer a
* Availability of imaging by injected abdominal scanner including at least one portal phase
* Age over 18

Exclusion Criteria:

* Patients with treatment of the hepatic nodule by ablation or previous hepatic surgery
* Imaging follow-up \<12 months
* Non-interpretable scanner (artefact, injection quality, etc.)
* Patients with more than 10 liver metastases
The Impact of Lingual Frenotomy on Bottle Feeding Mechanics

Conservative estimates show that 3-5% of all infants have tongue tie. These studies only focus on visible, anterior tongue tie. Deeper, more visibly subtle cases of ankyloglossia have not been included in these incidence numbers, so the percentage of children with ankyloglossia is much higher than previously thought. Previous research by the investigators demonstrates that posterior tongue tie can be as problematic as anterior ties.

An available FDA-approved feeding solution allows for the measurement of infant sucking motions. This allows for detection of changes following surgical intervention. Previous ultrasound studies show the importance of the upward movement of the tongue, but further lingual movement parameters following frenotomy have not been reported.

The primary goal of this study is to record changes in lingual movement following lingual frenotomy. The investigators plan to compare improvements over time between a control, non-intervention group and a frenotomy group. Secondary goals include recording validated outcomes of reflux and feeding efficiency.


Eligibility Criteria:
Inclusion Criteria:

* Babies who are already fully or partially bottlefeeding
* Have already worked with lactation consultant prior to appointment
* Diagnosis of tongue tie

Exclusion Criteria:

* Severe neurologic/cardiac/pulmonary comorbid diseases
* Twins/Triplets
* Other oral pathology (ie cleft lip/palate)
Atrial Fibrillation Prediction Trial.

Atrial Fibrillation (AF) is a common arrhythmia with a prevalence of 1.5-2%. This prevalence increases significantly after 80 years of age. After the appearance of first episode(s) some of the patients will present frequent arrhythmia recurrences moving from the paroxysmal status to the persistent and the permanent status of the continuous spectrum of the natural time course of AF. In contrast some other will not present further relapses. To study and predict the dynamic evolution of AF is clinically important, furthermore, the detection of different sub populations risk for AF relapses will determine and different therapeutic approaches.

Atrial Fibrillation (AF) is a common arrhythmia with a prevalence of 1.5-2%. This prevalence increases significantly after 80 years of age. In the presence of the Arrhythmia the risk of stroke increases five fold while the congestive heart failure and the mortality rates are increasing significantly also.After the appearance of first episode(s) some of the patients will present frequent arrhythmia recurrences moving from the paroxysmal status to the persistent and the permanent status of the continuous spectrum of the natural time course of AF. In contrast some other will not present further relapses. To study and predict the dynamic evolution of AF is clinically important, furthermore, the detection of different sub populations risk for AF relapses will determine and different therapeutic approaches. The study will include \> 500 patients 30-80 years old. Inclusion criteria is one up to five paroxysmal AF (PAF) episodes during the last three years. Patients during screening must maintaining Sinus Rhythm. Exclusion criteria are substrate of severe valvular diseases, congenital heart disease, previous heart surgery, hyperthyroidism, severe diseases of the autonomic nervous system, alcoholism, diseases affecting seriously the survival and absence of adequate cooperation for the study. Screening will include 12 lead surface digital ECG, 30 min High Resolution (1000 Hz) ECG recording from 3 pseudo orthogonal x,y,z leads system, and complete ECHO study (2D, PWD, TDI, Strain).Among other indices will be analyzed: P duration, P index, P dispersion, P wave signal for Late potentials, for Wavelets, PQ/RR Dynamics, Heart Rate Dynamics and various markers for the autonomic nervous system status.Primary end point is one or more PAF relapse(s) during a period of 12 months after recruitment in study.Secondary end point is permanent AF during a period of 36 months after recruitment in study.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria is one up to five paroxysmal AF (PAF) episodes during the last three years. Patients during screening must maintaining Sinus Rhythm.

Exclusion Criteria:

* previous heart surgery, hyperthyroidism, severe diseases of the autonomic nervous system, alcoholism, diseases affecting seriously the survival and absence of adequate cooperation for the study
Phase I, Single Centre, Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD3043

Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability,Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 after aSingle Ascending Bolus Dose Followed by a Single Infusion Dose in Elderly(=65 years) Healthy Volunteers

Phase I, Single Centre, Open Label Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous AZD3043 after a Single Ascending Bolus Dose Followed by a Single Infusion Dose in Elderly (=65 years) Healthy Volunteers

Eligibility Criteria:
Inclusion Criteria:

* Pre-anaesthesia assessment judged without remarks by the investigator.
* ASA physical status category 1 to 2 (up to and including 3 depending on applicable patient category)

Exclusion Criteria:

* Lack of a normal range of enzyme activity for BuChE
* Known or suspected history of hypersensitivity to drugs with a similar chemical structure or class to AZD3043 (e.g., emulsion-based products like Diprivan,Intralipid), allergies to soybean or peanut products or any other drugs intended for use during th
* Prolonged QTcF \>450 ms or shortened QTcF \<350 ms or family history of long QT syndrome.
A Study for Optimization of 6% Hydroxyethyl Starch Based Indocyanine Green Near-infrared Fluorescence Navigated Sentinel Lymph Node Biopsy for Breast Cancer Patients

A study for dosage-image optimization of 6% hydroxyethyl starch diluted indocyanine green for near-infrared fluorescence navigated sentinel lymph node mapping for breast cancer patient.

Pre-clinical experiment has shown using 6% hydroxyethyl starch (Voluven®) as a solvent, compared with pure water, can improve brightness of indocyanine green particles at the same concentration. Similar findings have been addressed using human serum albumin as a solvent for indocyanine green in previous studies, but there was no report using 6% hydroxyethyl starch as a solvent till now. This study aims for clinical translation and optimization of 6% hydroxyethyl starch diluted indocyanine green in breast cancer patients undergoing sentinel lymph node biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer, adults

Exclusion Criteria:

* Patient aged \< 20 years old
* Primary lesion without indication of sentinel lymph node biopsy in current guidelines (Low-risk ductal carcinoma in situ or metastatic breast cancer)
* Patient who is allergic to primary tracers (including Tc99m and blue dye)
* Patient who is allergic to indocyanine green