cyrilzakka/clinical-trials huggingface dataset:
Establishing the Microcirculatory Effects of Ticagrelor on Tissue Perfusion in Critical Limb Ischemia

This is a single center, prospective, randomized, unblinded, open-label, active controlled pilot study to evaluate the efficacy and safety of ticagrelor plus aspirin versus clopidogrel plus aspirin in patients with Rutherford Stage IV to VI PAD that have undergone a percutaneous transluminal angioplasty (PTA) of the lower extremities in the past 2 weeks.

Enrollment into the study will require severe symptomatic CLI without wounds (Rutherford Stage IV) or CLI with concomitant vascular insufficiency wounds (Rutherford Stage V-VI PAD).

Potential participants will be identified and screened prior to discharge or at the time of the first out-patient visit (within 2 weeks after discharge) after a percutaneous lower extremity arterial angiography with arterial intervention (stent or balloon angioplasty) for the presence of lower extremity vascular insufficiency. Participants will be classified as Rutherford Class IV - VI (with or without ulcerations). A total of 60 patients will be randomized into 2 treatment groups in a 1:1 ratio (ticagrelor to clopidogrel). Patients are placed on clopidogrel after their arterial intervention per standard of care. They will remain on clopidogrel up to the time that randomization occurs. For patients that are randomized to ticagrelor, the clopidogrel will be stopped.

Patients will be randomized to either ticagrelor 90mg by mouth twice daily or clopidogrel 75mg by mouth daily.

Eligibility Criteria:
Inclusion Criteria:

1. Adults age 18-100 years with Rutherford Classification Stage IV through VI PAD with a recent percutaneous lower extremity arterial angiography with arterial intervention in the past 2 weeks
2. Willingness to sign informed consent
3. Ability to return for follow up visits
4. A female patient of childbearing potential who is sexually active must agree to use adequate contraception from screening until 30 days after receiving the last dose of study drug. Women not of childbearing potential are defined as those who have surgically sterilized (hysterectomy, bilateral oophorectomy, or tubal ligation) or who are post menopausal (defined as at least 2 years since last regular menses). The female patient should not be lactating and must have a negative pregnancy test at screening.

Exclusion Criteria:

Patients will be ineligible for this study if they meet any one of the following criteria:

1. Intolerance to thienopyridines
2. Hypersensitivity to ticagrelor or any component of the product.
3. Concomitant use of oral anticoagulation with vitamin K antagonist, factor Xa inhibitor, or direct thrombin inhibitor
4. History of intracranial hemorrhage
5. History of severe hepatic impairment defined by baseline transaminase greater than or equal to 3x ULN or any elevation in bilirubin
6. Active bleeding
7. Allergy to aspirin
8. Baseline TcPO2 \< 10 mmHg post angiography
9. Resting, pre- procedure heart rate \<50 beats-per-minute without a permanent pacemaker and not on an atrioventricular nodal blocking agent
10. Severe COPD on home oxygen therapy -
Incremental Hemodialysis: The TwoPlus Trial

This study is to prospectively compare clinical effectiveness between clinically- matched incremental hemodialysis and conventional hemodialysis in patients with incident kidney dysfunction requiring dialysis and residual kidney function.

The study will enroll 350 patients on chronic hemodialysis and 140 caregivers of enrolled patients. Patients will be randomized in 1:1 ratio to either incremental start hemodialysis or conventional hemodialysis. Caregivers will be followed along with patients for an average period of 2 years post randomization.

This study will analyze the effects of differentiated care with individualized hemodialysis on patient health related quality of life, fatigue, employment, and caregiver burden in patients with Kidney dysfunction requiring dialysis (KDRD) and appreciable kidney function.

This study will compare the outcomes in survival, hospitalization, preservation of the kidney function and quality of life between hemodialysis tailored to each patient needs (incremental) and conventional hemodialysis.

Eligibility Criteria:
Patient eligibility Criteria:

Inclusion Criteria:

* Clinical Inclusion Criteria:
* Age ≥ 18 years
* Incident kidney dysfunction requiring dialysis (KDRD) started on maintenance, in-center hemodialysis (HD), or anticipated to be started on maintenance, in-center HD within the next 12 weeks
* Has received ≤36 sessions of intermittent HD (i.e., on HD for ≤12 weeks) at the time patient is approached for potential study participation

Residual Kidney Function Inclusion Criteria:

* Kidney urea clearance \<2.0 mL/min
* Urine volume# of ≥500 mL/24 h

Exclusion Criteria:

* Pre-HD serum K ≥5.8 mEq/L, Na ≤125 mEq/L, or bicarbonate level ≤17 mEq/L
* Requirement or anticipated requirement of high-volume ultrafiltration
* Unable or unwilling to follow the study protocol for any reason
* Known pregnancy or planning to attempt to become pregnant or lactating women
* Estimated survival or dialysis modality change or center transfer \<6 months

Caregiver Eligibility Criteria:

* be at least 18 years old
* be the main caregiver (at patient's choice)
* be a close relative of the patient (spouse, child, sibling, parent, grandchild)
* have no known psychiatric and neurologic disorders (through direct inquiry from the person)
* not be a member of the medical or healthcare team
* not be the caregiver for another patient with chronic illness
* not have experienced severe life events within prior 3 months of enrollment (through direct inquiry from the person)
Validity, Reliability and Feasibility of an Automated Photographic Measurement/Assessment of Food Intake in the Hospitalized Elderly

Malnutrition affects 50% to 70% of hospitalized elderly people, and is all the more worrying in the elderly because of its clinical impact. A measurement of food consumption is essential to recognize needs, monitor the nutritional status of the elderly in hospital and implement specific therapeutic action such as supplements or an increase in energy-protein to combat malnutrition or the risk of malnourishment. Unfortunately, this measure is rarely done effectively in practice, keeping the patient in nutritional deficit, contributing to a risk of increased morbidity and mortality.

Although weighing food intake is the reference method, it is a routine burden for healthcare teams. To overcome these constraints in hospital environments, intake is estimated by food readings over three consecutive days using a semi-quantitative method. It should be noted that this method remains complex, imprecise and reserved only for the most malnourished patients. In recent years, the development of photographic methods has become an interesting alternative to the measurement by weight. Based on photographs taken before and after the meal in order to deduce what is actually ingested, these methods obtain results comparable to the weighing method, though there is still a number of limitations (need for human intervention, constraint to have standardized menus in weight and lack of nutritional management adapted to patients). To overcome these limitations, an automated photographic method based on modern techniques for automatic processing of 2D and 3D images coupled with techniques derived from artificial intelligence has recently been developed in the investigator's unit, but has not yet been validated.

The originality and innovation of this project lies in the automated analysis of the photos taken and the conversion into percentage of remaining food thanks to the design of algorithms for image preprocessing and neural classification by a 2D and 3D software (patent pending).


Eligibility Criteria:
Inclusion Criteria:

* patient who has given oral consent to participate
* adult patient
* inpatient geriatric rehabilitation follow-up care (SSRG) and acute geriatric units
* patient eating alone or with help

Exclusion Criteria:

* patient with enteral or parenteral nutrition
* patient not affiliated to a social security scheme
* end-of-life patient or palliative care
Investigation of the Acute Cognitive, Mood and Autonomic Effects of Hops in Healthy Participants

Hops have been used for many years for their supposed sedative and anxiety reducing properties and can be found in many natural remedies for stress, anxiety and sleeping that are already available to buy.

However, human trials investigating the effects of hops have so far been limited to the effects of the combination of hops and valerian in relation to sleep. Such studies have identified that a valerian-hops mixture can result in improved sleep but Valerian alone has no effect.

The current study aims to investigate the effect of hops alone in healthy human participants aged 18-35 years.


Eligibility Criteria:
Inclusion Criteria:

* Male/female,
* Healthy
* Age 18-35 years old
* Non smoker
* Proficient in English
* Not taking any herbal or prescription medications
* Not pregnant seeking to become pregnant or breastfeeding

Exclusion Criteria:

* Allergy or hypersensitivity to any of the ingredients contained in the investigational product or any other foodstuff.
* Vegetarian (as the capsules contain gelatine).
* Have a history of neurological, vascular or psychiatric illness (including depressive illness and anxiety).
* Have a current/ history of drug or alcohol abuse.
* Currently take medication (excluding the contraceptive pill).
* High Blood Pressure (\>140/90)
* BMI outside of the range 18- 34.9
A Follow-up Evaluation for Safety in Subjects Who Participated in a Phase 1 Study With BMS-986094 (INX-08189)

The purpose of this study is to determine the rate of kidney or heart impairment, if any, in subjects who received BMS-986094 (INX-08189) in Phase 1 clinical trials


Eligibility Criteria:
Inclusion Criteria:

* Healthy and hepatitis C virus (HCV)-infected subjects who participated in prior Phase 1 trial with BMS-986094/INX-08189 and:

  1. Received at least 1 dose of INX-08189 or
  2. Received placebo in studies for HCV-infected subjects (INH-189-002 or INH-189-006)
* Age 18 or older

Exclusion Criteria:

-
Bendamustine in Combination With Bortezomib and Pegylated Liposomal Doxorubicin for Multiple Myeloma

This is an open label phase I/II trial to determine the safety and the biologic activity of the bendamustine, bortezomib and pegylated liposomal doxorubicin combination.

Phase I component Bortezomib 1.3 mg/m2 IV bolus, Days 1, 4, 8, and 11 Doxorubicin 30 mg/m2 IV over 1 hour, Day 4 Bendamustine escalating cohorts IV over 1 hour, Days 1 and 4 1 Cycle = 28 days

Phase II component Bortezomib 1.3 mg/m2 IV bolus, Days 1, 4, 8, and 11 Doxorubicin 30 mg/m2 IV over 1 hour, Day 4 Bendamustine at MTD IV over 1 hour, Days 1 and 4 Filgrastim (if defined in MTD) 5 µg/kg/day SC, Starting day 6 until neutrophil recovery to ANC \>1000

1 Cycle = 28 days; Patients will continue treatment for a total of up to 8 cycles.

ECOG Performance Status: 0-2

Hematopoietic:

* Absolute neutrophil count (ANC) ≥ 1.2 x K/mm3
* Platelets ≥ 75 x K/mm3

Hepatic:

* Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
* AST ≤ 2.5 x ULN
* ALT ≤ 2.5 x ULN

Renal:

* Serum creatinine \< 3.0 mg/dL

Cardiovascular:

* LVEF \>45% corrected by MUGA scan or echocardiogram.
* No unstable angina pectoris or recent myocardial infarction (within 6 months)

Eligibility Criteria:
Inclusion Criteria:

* A histologically established diagnosis of multiple myeloma with evidence of relapse or refractory disease.
* Must have a detectable serum or urine M-Protein by protein electrophoresis that is at least 500 mg/dL (serum) or 1 gm/24 hours (urine), respectively, or serum free light chain level \>100 mg/l for the involved free light chain.
* Must have received at least one (1) prior line of systemic treatment that has included either lenalidomide or thalidomide.
* Must be willing to provide correlative blood samples.

Exclusion Criteria:

* Must not have received an excessive cumulative dose of anthracycline
* No ≥ grade 2 peripheral neuropathy.
* No cytotoxic chemotherapy within 30 days prior to registration for protocol therapy.
* No autologous stem cell transplant within 6 months prior to registration for protocol therapy
* No prior radiation therapy to \> 25% of bone marrow forming bones (i.e., pelvis) within 30 days prior to registration for protocol therapy. See Study Procedures Manual to calculate percent of prior radiation.
* No current corticosteroid therapy in doses greater than 10 mg daily of prednisone (or equivalent) if given for management of co-morbid conditions.
* No known central nervous system involvement by myeloma.
* No poorly controlled intercurrent illness including, but not limited to, ongoing or active infection, poorly controlled diabetes, symptomatic congestive heart failure, cardiac arrhythmia, or psychiatric illness/social climate that in the opinion of the investigator would limit compliance with study requirements.
* No patients known to be positive for HIV, or active Hepatitis A, B, or C.
* No major surgery within 30 days prior to registration for protocol therapy. Placement of a venous access device within 30 days prior to registration for protocol therapy is allowed.
VCare Versus SecuFix Uterine Manipulator for Total Laparoscopic Hysterectomy

Hysterectomy, the most commonly performed gynecological operation, can be carried out through various methods using a wide array of instruments and energy techniques. Minimally invasive procedures such as robotic or laparoscopic approaches are linked to lower perioperative complications and quicker recovery when compared to abdominal hysterectomy. Furthermore, recent advancements in surgical tools and methodologies have facilitated endoscopic surgeries. Uterine manipulation plays a crucial role in laparoscopic hysterectomy by facilitating bladder dissection, positioning the ureters, and exposing the anterior and posterior vaginal fornices. It also prevents pneumoperitoneum loss by closing off the vaginal space. Despite these apparent benefits, there is no existing report comparing different types of uterine manipulators. Therefore, the purpose of this study was to compare the Vcare and SecuFix uterine manipulators used in laparoscopic hysterectomy based on operative time, length of hospital stay, estimated blood loss, perioperative complications, and subjective performance.

Introduction Hysterectomy is the most commonly performed gynecological operation and can be carried out through various methods using a wide array of instruments and energy techniques. Although the methods have advantages and disadvantages over each other, minimally invasive procedures are associated with less morbidity and perioperative recovery. Recent advancements in surgical tools and methodologies have facilitated endoscopic surgeries. Uterine manipulation is crucial in laparoscopic hysterectomy as it facilitates bladder dissection, positioning the ureters, and exposing the anterior and posterior vaginal fornices. It also maintains pneumoperitoneum. Currently, many uterine manipulators are available, but the evidence for their efficacy and safety is still unclear. The purpose of utilizing a uterine manipulator is to enhance surgical outcomes and reduce intraoperative complications, particularly concerning the bladder and ureter. It is important to visualize the anterior and posterior fornices and ensure maintenance of the pneumoperitoneum. Therefore, uterine manipulators play a crucial role in laparoscopic hysterectomy. However, none of the manipulators currently available possess all the characteristics of an ideal manipulator. Therefore, the investigators aimed to compare the Vcare and SecuFix uterine manipulators used in laparoscopic hysterectomy with regard to operative time, length of hospital stay, estimated blood loss, and perioperative complications.

Eligibility Criteria:
Inclusion Criteria:

* aged 35-65 years
* hysterectomy for benign gynecological indications

Exclusion Criteria:

* history of urogynecologic procedures
* suspected gynecological malignancy,
* endometriosis,
* pelvic inflammatory disease,
* pelvic organ prolapse,
* unavailibility of operative records
Prophylaxis of Hepatitis B Virus Recurrence After Liver Transplantation

Entecavir demonstrated superior virologic and biochemical benefits over lamivudine and adefovir. The investigators evaluated the effect of entecavir combined Hepatitis B immune globulin (HBIG) with lamivudine or adefovir or both combined HBIG in Chinese liver transplantation patients with Hepatitis B Virus (HBV) related diseases.


Eligibility Criteria:
Inclusion Criteria:

1. patients into the transplant waiting list with HBV-related liver disease.
2. HBsAg-positive.
3. serum HBV-DNA negative.
4. no HCV, HDV and HIV co-infection.
5. without renal dysfunction.
6. No lamivudine, adefovir and entecavir drug allergy history.
7. no HBV-YMDD mutation for patients who have a long-term use of lamivudine.

Exclusion Criteria:

1. patients with HBV-related hepatocellular carcinoma beyond Milan criteria.
2. HBsAg-negative.
3. serum HBV-DNA positive.
4. HCV, HDV and HIV co-infection.
5. patients with severe renal dysfunction or failure.
6. lamivudine, adefovir and entecavir drug allergy history.
7. HBV-YMDD mutation for patients who have a long-term use of lamivudine.
Sickle Cell Anemia and Cerebral Microcirculation : Multimodal Exploration

The aim of this study is to evaluate determinants of cerebral oxygenation and perfusion at the microcirculatory level in children with sickle cell anemia (SCA) using combined novel investigational tools: Arterial Spin Labeling (ASL) perfusion MR (Magnetic Resonnance) imaging, brain Near Infra-Red Spectroscopy (NIRS) and red blood cell (RBC) rheological properties.

The investigators hypothesize that brain perfusion and/or oxygenation modifications may be evidenced in SCA children who have no microarteriopathy and may correlate with hemorheological abnormalities and impaired vasomotion. A multimodal approach designed to study a. cerebral perfusion and oxygenation, b. flow motion properties and c. blood rheological parameters might help to describe the different processes involved in cerebral ischemia.

Eligibility Criteria:
Inclusion Criteria:

* SS or S-beta° genotype;
* age 6-16 years;
* steady state;
* normal TCD (Transcranial Doppler);
* parental study approval and written informed consent.

Exclusion Criteria:

* SC, Sbeta+, SD Punjab genotype
* history of overt stroke,
* intracranial or cervical arterial stenosis,
* abnormal TCD at the time of the study.
The Effectiveness of Using Preventive Multimedia Teaching Program in Lung Cancer Women Receiving Targeted Therapy on Skin-Related Quality of Life

The Effectiveness of Using Preventive Multimedia Teaching Program in Lung Cancer Women Receiving Targeted Therapy on Skin-Related Quality of Life


Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 20 years of age.
2. The first time to accept the target drug treatment (Iressa, Tarceva) treatment, diagnosis of lung cancer third or fourth stage of the women.
3. There are computer equipment at home to play the disc.
4. can speak, write, read Chinese, clear consciousness, no cognitive impairment.
5. In the medical center of Taipei, a medical department, medical or surgical clinic for treatment.

Exclusion Criteria:

* none
Nutritional Supplementation in Sarcopenic Obesity

The obese patient presents a quantitative and qualitative deficit of muscle mass as occurs in the elderly subject that was named Sarcopenic Obesity (SO). The use of a diet that includes protein supplements and / or essential amino acids seems to improve this condition in the elderly; there are no similar studies in obese subjects, in particular during a low-calorie diet and physical activity program that can produce further loss of muscle mass. This study aims to verify whether the administration of these supplements (protein or amino acid) in the obese patient are effective in improving anthropometric and functional parameters and some serum markers of muscle metabolism. The results obtained could represent new therapeutic protocols in the treatment of obesity.

Several studies have confirmed that adequate nutrition, especially protein intake, including at breakfast, or supplementation with amino acids, in association with adequate physical activity plays an important role in the treatment of SO.

The supplementation of protein or amino acid preparations (in particular with the 9 essential amino acids including, the branched - leucine, isoleucine, valine), marketed in different formulations, has already allowed to document a significant therapeutic efficacy in the treatment of elderly sarcopenic subjects. In fact, the use of these preparations improves physical performance and muscle strength by inducing the synthesis of proteins involved in the biogenesis and functionality of mitochondria - that is, the cellular organelles responsible for the production of energy in the form of ATP - and of myofibrillar proteins (which constitute the large percentage of muscle mass), both in laboratory animals and in humans.

Eligibility Criteria:
Inclusion Criteria:

* patients with obesity (BMI\> 35kg / m2)
* sarcopenia (criteria described in Coltorti A et al).

Exclusion Criteria:

* renal insufficiency
* diabetes
* muscular pathologies
* neurological-neurodegenerative pathologies
* cognitive decline
Effect of Pelvic Organ Prolapse Surgeries on Female Sexual Function in Egyptian Women

study on female sexual function after different prolapse surgeries


Eligibility Criteria:
Inclusion Criteria:

* sex active prolapse surgery

Exclusion Criteria:

* not sex active any psychiatric problem
Oxidative Stress in Response to Electroacupuncture Against Physical Activity in Diabetic Patients

OS is an important pathogenetic mechanism for the development of T2DM and its complications.

Oxidative stress is an imbalance of the generation of free radicals or known as reactive oxygen species (ROS) and reactive nitrogen species \[RNS\]) and their neutralization by the antioxidant mechanisms.

Increased levels of ROS and RNS lead to damage of lipids, proteins, and DNA, ultimately causing the destruction of the islet cells of pancreas through apoptosis . Elliptical trainer device is a relatively new modality of exercise and is advertised to be superior to a treadmill because of the low joint impact and the more reasonable costs of an elliptical trainer compared to a treadmill . Additional quantative research is needed to further evaluate the effectiveness of elliptical trainers and the physiological and perceptual responses to the machine Electroacupuncture (EA) is a treatment form of traditional acupuncture in which small electrical currents are passed through needles inserted into the subject's skin using EA stimulator. It seems to have more acceptable results and effects on many important clinical applications and medical research sets .

60 diabetic patients will be randomly divided to electroacupucture group (30 patients) and high intensity elliptical training (30 patients). the treatment will be done for 5 sessions per week for 12 weeks

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetic elderly
* Body mass index less than 30 kg/m2.
* Fasting blood more than 126 mg/dl

Exclusion Criteria:

* cardiac patients
* renal patients
* respiratory patients
* liver patients
* patients who received any complementary therapies within 3 past months
A Comparison of SLx-4090 in Combination With Metformin Versus Metformin Therapy Alone in Patients With Type 2 Diabetes

The purpose of this study is to determine whether SLx-4090 in combination with metformin therapy will reduce HbA1c in patients with Type 2 Diabetes more effectively than metformin therapy alone.

1. HbA1c after 12 weeks
2. FPG after 12 weeks
3. Safety and tolerability
4. Plasma levels of SLx-4090

Eligibility Criteria:
Inclusion Criteria:

* HbA1c 7-11%
* On a stable dose of metformin for at least 6 weeks

Exclusion Criteria:

* Type 1 Diabetes
* Antidiabetic medication other than or in addition to metformin
* FPG \> 270 mg/dL