cyrilzakka/clinical-trials huggingface dataset:
Combined Bilateral Uterine Artery Ligation and Bakri Balloon During Cesarean Section

This study will be performed to compare the effectiveness of routine Bakri balloon tamponade and Bilateral Uterine Artery Ligation during cesarean section in patients with placenta previa

Intraoperative methods to control profuse bleeding during cesarean section in patients with placenta previa include uterine packing, balloon tamponade, uterine compression sutures, arterial ligation, uterine artery embolization, and hysterectomy.

Eligibility Criteria:
Inclusion Criteria:

* women undergoing elective cesarean delivery for complete placenta previa which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures

Exclusion Criteria:

* patients with the high possibility of morbid adherent placenta
* those presented with severe antepartum hemorrhage
* Patients with cardiac, hepatic, renal, or thromboembolic disease;
* patient refuses to consent
AR and ER Imaging in Metastatic Breast Cancer

Knowledge of breast cancer estrogen receptor (ER) expression is of major importance in treatment-decision making. Patients with ER-positive tumors can be treated with anti-oestrogen therapy, which has relatively few side effects compared to chemotherapy. Whole-body tumor ER-expression can be visualized by 18F-fluoroestradiol PET imaging (FES-PET). In addition to ER, the androgen receptor (AR) is a potential new target in breast cancer. PET imaging with 18F-fluorodihydrotestosterone (18F-FDHT) may allow visualization of tumor AR-expression. In the current study we will perform FES-PET and FDHT-PET in metastatic breast cancer patients and evaluate the concordance with concurrent biopsies. Molecular imaging of tumor AR- and ER-expression may well be of value for future treatment decision-making.


Eligibility Criteria:
Inclusion Criteria:

1. Metastatic breast cancer, with at least one known metastasis outside of the liver
2. Presence of a lesion that is safely accessible for tumor biopsy (may be liver lesion)
3. Postmenopausal status defined as one of the following:

   * age ≥60 years
   * previous bilateral oophorectomy
   * age \<60 years and amenorrhea for \>12 months in the absence of interfering hormonal therapies (such as LH-RH agonists and ER-antagonists)
   * patients age \<60 years using an ER-antagonist should have amenorrhea for \> 12 months and FSH \>24 U/L and LH \>14 U/L e. patient age \<60 years using LH-RH agonists should continue LH-RH-agonists until after the PET procedures
4. Initially ER-positive tumor histology.
5. ECOG performance status 0-2.
6. Signed written informed consent
7. Able to comply with the protocol

Exclusion Criteria:

1. Use of estrogen receptor ligands, including tamoxifen, fulvestrant or estrogens, or androgen receptor ligands, during the 6 weeks before entry into the study
2. Life-expectancy ≤ 3 months
The Effects of Spinomed Orthosis and Biofeedback Orthosis in Elderly Individuals With Thoracic Hyperkyphosis

Hyperkyphosis, defined as excessive sagittal curvature of the thoracic spine, is the most common spinal deformity in elderly individuals. The prevalence of hyperkyphosis in elderly individuals is reported to be between 20% and 40%. Hyperkyphosis affects the mobility, walking, and balance of the individual negatively and causes changes in the physical performance of elderly individuals. Therefore, it is important to evaluate and treat hyperkyphosis in elderly people. One of the approaches to treating people with hyperkyphosis is the use of spinal orthoses such as the Spinomed orthosis and Biofeedback orthosis. Regular use of spinal orthoses reduces the angle of kyphosis by 11%. In addition, spinal orthoses help increase walking speed and distance, improve balance, and prevent falls. Spinomed and Biofeedback soft posture orthoses are spinal orthoses used in the treatment of kyphotic posture. Studies on Spinomed orthosis have demonstrated that it strengthens postural muscles, and therefore also prevents falls. Soft orthoses, which provide feedback, provide a warning to the individual through sound or vibration when the spinal alignment of the individual is disturbed, and provide the correction of posture with active muscle strength. However, little evidence exists regarding the effect of these two orthoses on improving balance and walking performance in elderly people with thoracic hyperkyphosis. Therefore, this study was developed to enable a comparison of the effect of the Spinomed orthosis and the biofeedback orthosis on balance and walking performance in elderly people with thoracic hyperkyphosis.

Volunteer healthy elderly individuals between the ages of 60-80 will be recruited into our study and the individuals will be randomly divided into two groups Spinomed orthosis and postural orthosis which provides biofeedback. In both groups, balance and gait assessments with or without orthosis will be done twice.

Eligibility Criteria:
Inclusion Criteria:

* having an age of 60 years or above
* the ability to walk at least 10 meters independently
* thoracic hyperkyphosis angle above 40 degrees
* Mini-mental test score greater than 24

Exclusion Criteria:

* having fractures or surgery on the spine or lower limbs within the last 12 months
* having degenerative impairment in the spine, such as scoliosis and osteoarthritis
* having any neurological and cognitive impairment
The Relationship Between IRRIV and RFR Under Pathologic Conditions

The assessment of renal functional reserve (RFR) has been proposed for the risk stratification of patients undergoing potentially nephrotoxic procedures. The present pilot study is designed to explore the correlation between IRRIV and RFR under pathologic conditions.

Renal functional reserve (RFR) represents the capacity of the kidney to increase glomerular filtration rate (GFR) in response to certain physiological or pathological stimuli or conditions.

RFR is calculated as the difference between the measured maximum GFR achieved through a renal stress test and the baseline GFR measured in rest conditions. In clinical practice, the most common renal stress test is performed as a standardized protein loading test. Recently, in a pilot study, the investigators demonstrated a significant correlation between RFR and the intra-parenchymal renal resistive index variation (IRRIV) during an echo renal stress test in a cohort of healthy volunteers. IRRIV test has proven to be rapid, safe, bedside and easy to perform and it might represent a preliminary test in screening patients' RFR.The present pilot study is designed to explore the correlation between IRRIV and RFR under pathologic conditions.

Eligibility Criteria:
Inclusion Criteria:

* Estimated GFR (CKD-EPI) greater than or equal to 60 mL/min/1.73 m2
* Scheduled cardiac surgery with cardiopulmonary bypass (coronary artery bypass, valve replacements, combined or other operations).

Exclusion Criteria:

* Age less than 18 years old
* Pregnancy
* Ultrasound evidence of morphological kidney abnormalities and/or renal artery stenosis
* Nonsteroidal anti-inflammatory drugs (NSAIDs)
* Contrast media in the 2 days before the tests.
Peripheral Nerve Responses to Focal Vibration and Implications in Pain and Mobility for Patients With Diabetic Peripheral Neuropathy

The purpose of this study is to characterize the changes in peripheral nerve functions (sensory and motor) in patients with diabetic peripheral neuropathy, and examine the relations between the changes in nerve functions and changes in pain and mobility using focal vibration.

Peripheral nerve impairments are highly prevalent in patients with diabetic peripheral neuropathy (DPN) and are associated with pain and poor mobility. While peripheral sensorimotor nerve function is implicated in neuropathy, the mechanism associated with both pain and mobility is not well understood. Even less understood is the interplay between, and responses to, sensory and motor fibers of the affected peripheral nerve. In our previous study, focal vibration (FV) was effective in reducing pain and improving mobility for only a subgroup of participants with DPN. Because FV stimulates both motor and sensory peripheral nerve fibers, when combined with nerve conduction testing, it offers a unique opportunity to study both the sensory and motor peripheral nerve performance and their contribution to pain and mobility in patients with DPN. We are proposing a single group, repeated measured study to: characterize the changes in sensory and motor peripheral nerve functions; examine the association(s) between these changes and changes in pain and mobility, using FV. If successful, this study will provide us with a better understanding of the role played by sensory and motor nerve impairments in pain and mobility for DPN, and support larger clinical studies to optimize nerve function performance and the FV parameters. We will also explore how changes in the peripheral nerve function associate with severity of DPN.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetes for at least one year;
* Diabetic peripheral neuropathy as defined by failure to sense the 5.07 (10g) monofilament test in one or more of the six sites tested;
* Age 45-80 years old;
* Able to ambulate independently without assistive devices (e.g., walker or crutches) for 30 feet;
* No evidence of neurological (other than peripheral neuropathy) or orthopedic conditions;
* Able to understand English instructions;
* Have normal or corrected vision.

Exclusion Criteria:

* With other non-diabetic causes of neuropathy by history;
* Symptomatic peripheral vascular disease, joint pain, swelling and/or limited range of motion in the lower extremities that interfere with walking;
* Other systemic or local diseases that could interfere with walking assessment
* Amputation in the lower extremities;
* Clinically diagnosed with dementia greater than mild (screened using Montreal Cognitive Assessment (MOCA) \<24)
Long-term QoL in Acute Promyelocytic Leukemia Treated With ATO or Standard Chemotherapy

This is a prospective and international observational study run by the GIMEMA. All data will be centrally collected and analyzed at the GIMEMA Data Center in Rome (Italy). Patients reported outcomes will be collected using internationally validated questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* APL survivors enrolled in GIMEMA APL0406 clinical trial and in first molecular CR after third consolidation treatment
* Written informed consent.

Exclusion Criteria:

* APL patients previously enrolled in GIMEMA APL0406 trial who cannot be reached or who are lost to follow-up.
The Clinical Value of FA in AHLRI Patients

LRTI (Lower respiratory tract infection) is a severe disease in China. The fast and accurate diagnosis of pathogens, bacteria or viruses that cause the infection is critical for the therapy. In this study, investigators assume that the use of FilmArray Respiratory Panel will provide more rapid and comprehensive evidences to physicians to diagnose LRTI which is caused by viruses or atypical pathogens and then reduce the length of antibiotics use by 0.5-1.0 days as well as other hospital resources (length of hospital/ICU stay, take-away oral antibiotics, etc.). Secondly, investigators assume that in LRTI patients with viral infection and a low serum PCT level, fewer length of antibiotics use can be expected. Thirdly, the use of FilmArray Respiratory Panel will provide clearer epidemiology data of virus and atypical pathogens in hospitalized LRTI patients.


Eligibility Criteria:
Inclusion Criteria:

* Adults age \>= 18 years old
* Community acquired Pneumonia, acute exacerbation of chronic obstructive pulmonary disease \[AECOPD\], acute exacerbation of bronchiectasis.
* Hospitalization required
* Informed Consent Form signed

Exclusion Criteria:

* Age \< 18 years old
* Hospital acquired Pneumonia
* Patients with lung tuberculosis
* Pregnant women
* Patients with immunodeficiency
* Any conditions which may increase PCT levels
* Informed Consent Form not signed
Self-monitoring and Reminder Texts to Increase Physical Activity After Cancer: a Pilot Randomized Controlled Trial

Epidemiologic data consistently indicate that colorectal cancer survivors can improve their quality-of-life and prognosis by engaging in physical activity. This study aims to build on this epidemiologic work and translate the findings to inform and change patient behavior. The specific aims are to: (1) Develop a mobile technology physical activity intervention among colorectal cancer patients who have completed therapy. (2) Conduct a 3-month pilot randomized controlled trial utilizing mobile technology to increase physical activity among 40 men and women who have completed standard cytotoxic chemotherapy for primary stage I-III colorectal cancer at the UCSF Helen Diller Family Comprehensive Cancer Center. Participants in the intervention arm will receive a Fitbit® for self-monitoring, interactive text messages, and educational print materials; participants in the control arm will receive educational print materials at baseline and will be given a Fitbit® after completion of the 3-mo. follow-up assessment.


Eligibility Criteria:
Inclusion Criteria:

* stage I-III colon or rectal adenocarcinoma
* completed standard cytotoxic chemotherapy if medically indicated
* be considered disease-free at baseline
* be able to speak and read English
* have no contra-indication to moderate to vigorous aerobic exercise
* be able to walk unassisted
* be inactive at baseline (\<150 min/week of moderate physical activity)
* have access to a mobile phone
* be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet
An Efficacy and Tolerability Study of TRAVATAN® Versus LUMIGAN®

The purpose of this study is evaluate effects of TRAVATAN® versus LUMIGAN® on intraocular pressure (IOP) and ocular surface and inflammatory biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with either open-angle glaucoma or ocular hypertension in at least one eye and be treatment naïve to any glaucoma treatment.
* Intraocular pressure (IOP) between 19 mmHg and 35 mmHg in at least one eye, which would be the study eye.
* IOP considered to be safe (in the opinion of the investigator), in both eyes, in such a way that should assure clinical stability of vision and the optic nerve throughout the study period.
* Able to follow instructions and be willing and able to attend all study visits.
* Best corrected Snellen visual acuity of 6/60 (20/200, 1.0 LogMAR) or better in each eye.
* Must read, sign, and date an Ethics Committee-approved informed consent form.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Known medical history of allergy, hypersensitivity or poor tolerance to any components of the study medications to be used in this study that is deemed clinically significant in the opinion of the Principal Investigator.
* Any abnormality preventing reliable applanation tonometry in either eye.
* Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye.
* Prior treatment of dry eye with punctal plugs, punctal cautery, Restasis® or topical ocular corticosteroids.
* History of ocular surface disease (dry eye) or current/prior use of dry eye medications (either over-the counter or prescription medications).
* Contact lens wear.
* Intraocular conventional surgery or laser surgery in either eye that is less than three months prior to the Screening Visit.
* Use of any systemic medications known to affect IOP (e.g., oral beta-adrenergic blockers, alpha-agonists and blockers, angiotensin converting enzyme inhibitors and calcium channel blockers), which have not been on a stable course for at least 7 days prior to Screening Visit or an anticipated change in the dosage during the course of the study.
* Women of childbearing potential not using reliable means of birth control, are pregnant, or lactating.
* Unwilling to risk the possibility of darkened iris or eyelash changes.
* Participation in any other investigational study within 30 days prior to the Screening Visit.
* Other protocol-defined exclusion criteria may apply.
Effects of Butyrate on Colonic Health of Patients With Diarrhoea Predominant IBS and UC in Remission

Short chain fatty acids (mainly butyrate, acetate, and propionate) are produced in the large intestine by bacterial fermentation of undigested carbohydrates, such as dietary fibres. Butyrate is an important energy source of the intestinal epithelium and has a pivotal role in the regulation of epithelial cell proliferation and differentiation, immune function and mucosal protection.

Non-digestible carbohydrates (prebiotics) increase the concentrations of colonic butyrate, which has been proposed to be responsible for its beneficial effects. Furthermore, butyrate enemas have been proven to be effective in the treatment of active ulcerative colitis.

In the present study, the direct effects of butyrate on inflammation and parameters of colonic defence and mucosal integrity of the distal colon will be studied in 40 patients with diarrhoea predominant IBS (D-IBS) and 40 patients with ulcerative colitis in remission (UCrem) using rectal enemas. These patients groups were chosen because they have a low-grade inflammation in the large intestine, and can therefore be used as a model to study the mechanistic effects of butyrate. The design used to study the effects of butyrate in both patient groups will be a double blind randomized placebo-controlled parallel design.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of UC or Diarrhea predominant IBS
* Stable western diet
* Age between 18 and 65
* BMI between 18 and 35
* Written informed consent

Exclusion Criteria:

* All enemas and suppository during or 2 weeks prior to the study
* Use of corticosteroids during or 1 month prior to the study
* Use of antibiotics during or 3 months prior to the study
* Budesonide during or 2 weeks prior to the study
* Changes in medication during or 1 month prior to the study
* Lactation, pregnancy and planning of pregnancy
* Previous intestinal surgery
* Clinically significant systemic diseases
* Excessive drinking (\>20 alcoholic consumptions per week)
* Changes in prebiotic and/or probiotic use during and 2 weeks prior to the study
* Previous radiotherapy or chemotherapy
Liquid Biopsy Based Multiomics Study for Colorectal Cancer Early Screening

The primary objective is to determine the diagnostic sensitivity and specificity of the newly developed liquid biopsy based multiomics Colorectal Cancer (CRC) screening test (CRC-Appareo) for detecting advanced neoplasia (including colorectal cancer and advanced adenomas) in high risk patients and patients with confirmed CRC, using colonoscopy as the reference method. The secondary objective is to compare the screening performance of the multiomics Colorectal Cancer (CRC) screening test with commercially available FIT (Fecal Immunochemical Test) assay in detecting advanced neoplasia.

The study will be carried out in 5 hospitals throughout China. Patients who are at high risk of developing CRC or confirmed CRC and willing to conduct colonoscopy examination will be asked to collect blood prior to bowl preparation for multiomics CRC screening test which using Reduced Representation Bisulfite Sequencing (RRBS) technology to obtain multidimensional variation information on cell-free DNA (cfDNA) methylation, end sequence, fragment size distribution, and copy number variation in the blood, and integrate analysis through machine learning algorithms to accurately assess the risk of colorectal cancer and advanced adenoma. and will be asked to collect stool sample for commercially available FIT assay. Colonoscopy and histopathologic examination are used as reference. The diagnosis information of each sample was blind to the participants who conduct the multiomics profiling, as well as the informatics who perform the integrate analysis.

Eligibility Criteria:
Inclusion Criteria:

Willing to provide written consent Able to provide blood and stool samples

For high risk CRC screening group:

Scheduled for colonoscopy voluntarily or by physician prescription

CRC high risk profile as defined below:

History of FIT positivity Family history of CRC Any of two of the following clinical symptoms: chronic constipation/diarrhea, stool with mucous, chronic appendicitis, chronic bilary track diseases, mental stress

For CRC group:

Confirmed CRC patients No prior treatment with chemotherapy, radiotherapy, and prior to any surgical procedures

Exclusion Criteria:

Unwilling to provide blood samples FAP (familial adenomatous polyposis), Crohn's disease, ulcerative colitis Prior history of colonoscopy within the past 5 years and removal of lesions History of CRC other conditions deemed not suited for the study by investigators
Two Dose Epidural Morphine for Post-cesarean Analgesia

The investigators aim to assess the analgesic effect of a two-dose epidural morphine regimen for 2nd day post-cesarean pain, as part of a multimodal analgesia regimen, which includes scheduled Nonsteroidal anti-inflammatory drugs (NSAIDs). The investigators hypothesize that administration of a second dose of epidural morphine 3 mg, 24 hours after an initial intraoperative dose, will provide superior post-cesarean analgesia during the 2nd 24 hours after surgery, compared to a single epidural morphine dose regimen. The primary outcome will be the amount of intravenous morphine patients self-administer during the 2nd 24 hours post-surgery.

This will be a randomized, double-blinded placebo-controlled study. In this study, women who underwent cesarean section with epidural anesthesia will receive 3 mg of epidural morphine intraoperatively, and have the epidural catheter left in place. Patients will be randomized to receive either epidural saline or epidural morphine 3 mg at 18 - 24 hours after the first dose of epidural morphine, following which the epidural catheter will be removed. It is standard of care at our institution for women undergoing cesarean section with epidural anesthesia to receive epidural morphine 3 mg. What is not typically carried out is to give a second dose of epidural morphine 3mg.

The randomization will be carried out by a computerized block randomization table; the proportion for the 2 groups will be 1:1. The primary outcome will be the amount of intravenous morphine patients self-administer in the second 24 hours after surgery. Secondary outcomes will include pain scores every 6 hours, satisfaction with analgesia, side effects (itching, nausea/vomiting).

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing cesarean section under epidural anesthesia.

Exclusion Criteria:

* Emergent cesarean section
* Coagulopathy
* Failed epidural anesthesia or patchy block
* General anesthesia
* Use of epidural chloroprocaine
* Allergy or contraindication to Non-steroidal anti-inflammatory drug (NSAIDs)
* Severe opioid side effects
* History of chronic opioid use
* History of chronic pain
* History of obstructive sleep apnea
* Morbid obesity (Body Mass Index (BMI)\>45 kg/m2)
* Height under 4' 10" (147 cm)
* Documented dural puncture by the epidural (Tuohy) needle
* Preeclampsia
* Other significant medical disease (American Society of Anesthesiologists (ASA) 3 or more).
Retrospective Treatment Pattern Survey for the Patient With and Without History of Stroke

This study will compare hypertension treatment pattern of stroke patients with non-stroke patients receiving medical care from outpatient clinics at neurology specialty centers in Korea. It will evaluate target BP achievement rate in patients with stroke compared to patients without stroke and investigate factors affecting BP target goal efficacy in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Outpatients attending neurology specialty centers, either with or without history of stroke, receiving hypertension medication

Exclusion Criteria:

* Secondary hypertension patients
* Patients not receiving hypertension medication