cyrilzakka/clinical-trials huggingface dataset:
Tamponade vs Partial Myometrial Resection of Lower Uterine Segment in Management of Placenta Accreta Spectrum Cases

To compare the efficacy of lower uterine tamponade and partial lower myometrial resection in the management of intraoperative bleeding in cases with placenta accreta spectrum .

Placenta accreta spectrum (PAS) represents the spectrum of clinical conditions when part or whole of the placenta becomes abnormally adherent or invades the myometrium (1-2). Over the last 40 years, caesarean delivery rates around the world have risen from less than 10% to over 30%, and almost simultaneously a 10-fold increase in the incidence of PAS (3). PAS is one of the most dangerous conditions of the pregnancy as it is significantly associated with maternal morbidity and mortality (4).

Ultrasound imaging is the most commonly used technique to diagnose PAS disorders prenatally. There is also wide variation globally on the management of PAS disorders, with some centres opting for a radical approach, whereas others have proposed a range of conservative approaches (5).

The conservative approaches include one-step conservative surgery, leaving the placenta in situ, the Triple-P procedure, and transverse B-Lynch suture (1). Several techniques have been described for controlling massive bleeding associated with placenta previa caesarean sections ,including uterine packing with gauze ,balloon tamponades ,the B-Lynch suture,insertion of parallel vertical compression sutures, a square suturing technique and embolization or ligation of the uterine and internal iliac arteries , but there is awide variation in the success rate of these maneuvers. Over-sewing of the bleeding site is the most common procedure used for PPH management, but in many cases, the bleeding points located in the lower segment and cervical canal are too deep and their locations are unclear because of the severity of the bleeding(

Eligibility Criteria:
Inclusion Criteria:

* 1-Pregnant women with placenta previa /PAS diagnosed before delivery (by ultrasound and Doppler examination) .

  2 - Gestational age starting from 28 weeks onwards. 3- Women with at least 1 previous hysterotomy (e.g. Caesarean deliveries, myomectomy) 4- Elective or emergent Caesarean deliveries

Exclusion Criteria:

* A pre-existing decision of performing intrapartum hysterectomy
Effect of Losartan on Retinal Endothelial Function in Patients With Essential Hypertension

Essential hypertension is commonly associated with impaired endothelial function. The retinal vasculature is morphologically and functionally related to the cerebral vessels because of the common origin from the internal carotid artery. A recent study in hypertensive patients demonstrated that endothelial function of the retinal vasculature is impaired in hypertensive patients and that it can be restored by treatment with an AT1-receptor antagonist. It is not clear whether this effect is due to blood pressure lowering or whether this is a blood pressure independent effect. The present randomized, double blind study with a cross over design addresses this issue by comparing the effects of losartan and metoprolol on retinal endothelial function in patients with essential hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 18-65 years with essential hypertension

Exclusion Criteria:

* Secondary forms of hypertension
* Advanced damage of vital organs (grade III and IV retinopathy)
* History of serious hypersensitivity reaction to AT1-receptor blockers
* Actual or anamnestic alcohol- or drug abuse.
* Smokers or ex-smokers \< 1 year.
* Patients with Diabetes mellitus (oral medication or insulin).
* Patients with arterial fibrillation or AV-Block (II° or more).
* Patients with anamnestic myocardial infarction.
* Patients with instable angina pectoris including EcG-aberrations or cardiac insufficiency NYHA III or IV.
* History of malignancy (unless a documented disease-free period exceeding 10 years is present) with teh exception of basal cell carcinoma of the skin
* History of allograft transplantation
* Therapy with not approved concomitant medication, or participation in a clinical study within 4 weeks preceding treatment start.
* Disease which interfere with the pharmacodynamics and pharmacokinetics of the study drug.
* Liver-or kidney disease with SGOT, GPT, g-GT, AP, bilirubin and creatinin or above 200% of standard.
* Patients, who are not sufficiently compliant, or patients, who are not capable or willing to appear for controlling vistas.
* Presumed risk of transmission of HIV or hepatitis via blood from the participant
Structured Mobile Technology Based Lifestyle Program vs Usual Care for Patients With Non-alcoholic Fatty Liver Disease

This study will look at physical activity and nutrition in patients with non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH). The researchers will see if providing patients with NAFLD/NASH with specific physical activity and nutrition feedback as an addition to their usual clinical care helps them to lose weight and improve liver-related parameters.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH)
* Access to mobile phone/tablet/ or computer compatible with FitBit application and ability to use said device and application
* Ability to participate in physical activity

Exclusion Criteria:

* Any other form of liver disease( Alcohol related liver disease; viral hepatitis, autoimmune liver disease, hereditary forms of liver disease, etc.)
* History of decompensated cirrhosis
* Plans for invasive procedures or other regimented lifestyle programs for weight reduction
* Cardiovascular event in the previous 3 months
Autologous Platelet-Rich Plasma Cream for Photoaging and Chronological Skin Aging

Human skin undergoes some morphological changes with the effects of chronological aging and photoaging, these are especially remarkable in the facial skin. Changes in pigmentation, sallowness, deep wrinkling, laxity and elastosis are the main changes seen in photoaging and chronologic aging of skin. With the increasing demand, it needs to provide new approach for the prevention and treatment of these morphological changes.

Fibroblasts have a key role on skin aging. It is known that platelet rich plasma activates the fibroblasts and increases the synthesis of collagen and other type of matrix components. Because of these specialities, platelet rich plasma is thought to be effective on skin aging.

Clinical evaluation of the patients will be done for five times during 3 months. 0th day (Basal), 7th day, 15th day, 45th day and 105th day.

Eligibility Criteria:
Inclusion Criteria:

* The patient has periorbital wrinkles with Glogau Scale 3 or more

Exclusion Criteria:

* Patients with precancerous lesions
* Patients with inflammatory skin disease like rosacea, psoriasis, seborrheic eczema
* Patients with connective tissue disease like lupus erythematosus
* Patients have a cosmetic intervention to their face, like chemical peel, infrared, radio frequency, laser, fillers or botulinum toxin injections in last 6 months
* Patients who use an anti aging cream containing retinoic acid, vitamin C and peptides in last 3 months
* Pregnant or lactating females
Effect of Stent Placement on Short Term Survival of Left Sided Obstructive Colorectal Cancers

The aim of this observational study is to determine effect of stent placement on survival results in first three years in a patient who applied to the emergency department with obstruction due to colorectal cancer. Eligible patients divided into two groups. Group A includes patients underwent emergency surgery directly. Patients underwent elective surgery following stent placement as bridge-to-surgery. Patients underwent elective surgery following bridge-to-surgery stent placement were accepted as Group B.

Patients who applied to emergency department of a single tertiary referral center between January 2016 and December 2020 and diagnosed as left sided obstructive colorectal cancer were included in this retrospective study. All patients were equal or older than 18 years and histopathologically found to have primary colorectal malignant neoplasms.

Patients were excluded from the analysis if they met any of the following criteria:

* Who underwent emergency surgery due to unsuccessful stent application intervention or stent-related complications developed,
* Those with middle and lower rectum tumors or received neoadjuvant treatment,
* Perforation,
* Who underwent subtotal or total colectomy (as a result of colon ischemia in the cecum, microperforation, etc.),
* Recurrent disease patients
* Patients have metastasis

Eligibility Criteria:
Inclusion Criteria:

* All patients were equal or older than 18 years and histopathologically found to have primary colorectal malignant neoplasms and diagnosed as left sided (descending colon, sigmoid colon and upper rectum) obstructive colorectal cancer were included

Exclusion Criteria:

* Who underwent emergency surgery due to unsuccessful stent placement intervention
* Who underwent emergency surgery due to stent-related complications
* Those with middle and lower rectum tumors
* Those received neoadjuvant treatment,
* Patients have perforation,
* Who underwent subtotal or total colectomy (as a result of colon ischemia in the cecum, microperforation, etc.),
* Who has a recurrent disease or metastasis.
Leveraging the Seasonal Malaria Chemoprevention Platform to Address Malaria and Malnutrition

In the Sahel, the malaria and malnutrition seasons overlap during the rainy season, from approximately July through October. Malaria transmission increases due to the rain and collection of standing water and malnutrition risk increases because this period is the growing season, leading up to the annual harvest in November. Seasonal malaria chemoprevention (SMC) is an antimalarial intervention that involves monthly distribution of sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ) to children aged 3-59 months during the high malaria transmission season. SMC is distributed to millions of children annually in 13 countries in the Sahel, including Burkina Faso. Although SMC distribution is highly effective against clinical malaria in children, malaria remains a major cause of childhood mortality and morbidity in Burkina Faso. The SMC platform, which involves monthly door-to-door delivery of SP-AQ, is an attractive platform for delivery of additional interventions that may augment child health during this vulnerable season. Malaria and malnutrition co-occur in children and communities, and interventions for one may affect the other. For example, previous work by our group and others has shown that antimalarial treatments may improve weight gain in children with malnutrition. Here, we propose a pilot trial designed to evaluate how the SMC platform may be leveraged to deliver co-interventions with SMC that may augment its efficacy and reduce the incidence of malaria and malnutrition. We anticipate that the results of this study will provide formative data for the development and implementation of a full-scale study evaluating the effects of integration of nutritional interventions on the SMC platform. We anticipate that such a strategy may provide optimal protection for children during the most vulnerable period of the year by delivering interventions monthly on an existing platform that directly reaches millions of children each month.


Eligibility Criteria:
Children will be eligible for inclusion in the trial if they meet all of the following criteria:

* Live in the study community
* Eligible for SMC
* No allergy to peanuts
* Able to orally feed
* Within the eligible age ranges:

  * 6-59 months for nutritional screening
  * 6-24 months for SQ-LNS provision
* Written informed consent from at least one caregiver
* Caregiver is at least 18 years of age

Children will be recruited during normal distribution (via door-to-door delivery) for SMC, which occurs monthly during the malaria season (July through October).

Children ages 3-6 months are eligible for SMC and will be included in nutritional screening and monitoring but will not be eligible for SQ-LNS, which is designed for children ages 6-24 months.

A random sample of children ages 6-24 months during the first month of distribution will be asked to participate in an active surveillance cohort. These children will be followed weekly for screening for malaria and monthly for hemoglobin and anthropometric measurements.
Study of Biological Markers in Children With Sickle Cell Disease

Sickle cell disease is associated with significant morbi-mortality hence the interest in an early and targeted care. At present, there is no plasmatic marker able to identify infants at higher risk of developping severe complications later in life. However, recent studies have demonstrated a correlation between certain complications of the disease and biomarkers of the endothelial dysfunction characterizing it.

Investigators prospectively followed a cohort of children diagnosed with SCD through the universal neonatal screening using inflammatory and haemostatic plasmatic markers to study their annual evolution. Investigators then will evaluate potential associations between these biological markers and the occurrence of SCD related complications. A secondary objective of this study is to evaluate the repercussions of therapeutic intervention on these markers.

.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged less than 6 months
* Sickle cell syndrome SS, Sβthal or SC confirmed by hemoglobin electrophoresis
* Subjects legal representatives must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to let participate their child in the study

Exclusion Criteria:

* Congenital abnormality other than sickle cell disease except for a glucose-6-phosphate-deshydrogenase
* Prematurity
* Initiation of the following therapies before enrollment: chronic transfusion regimen or bone marrow transplantation
Refractive and Topographic Changes After Strabismus Surgery

Strabismus, characterized by a misalignment of the eyes, is a common condition that can result in functional and cosmetic issues, often affecting vision and binocular coordination. Strabismus surgery aims to correct the alignment by adjusting the extraocular muscles, but while the primary goal of surgery is to restore ocular alignment, refractive changes may occur as a secondary effect (1).

The traditional view of strabismus surgery is that it is more difficult to plan than to perform. Nevertheless, some complications sometimes have some clinical significance and may affect the visual acuity, physical appearance, and future life of the patients (2).

Refractive changes are among the complications of strabismus surgery. This is mostly attributed to the fact that surgical interventions to the extraocular muscles change the vectorial forces transmitted to the cornea via the scleral pathway (3).

Other theories on this subject include postoperative scleral wound healing, edema in the orbit and eyelids, change in ciliary body blood flow, and change in crystalline lens shape and curvature. In addition, if the anterior ciliary arteries are damaged during strabismus surgery, the supply of the anterior segment may be disrupted and changes in parameters may occur accordingly (4).

Also, surface tension changes in adjacent tissues due to changes in muscle tension after surgery may result in changes in corneal and anterior segment measurements (5).

The timing of refractive changes after surgery also varies. Some patients experience changes in their refractive status shortly after surgery, while others may develop these changes months or even years later. This delayed onset can make it more challenging to identify the precise cause of the refractive shift, as it may not always be immediately apparent following the initial surgical correction (6).

Research shows that post-strabismus surgery can result in myopic shifts, especially in patients with esotropia, and hyperopic shifts in exotropia. Astigmatism can also develop due to corneal shape changes. Preexisting refractive errors, age, strabismus type, surgical technique, and surgeon experience also influence post-surgical changes .

To investigate the refractive changes that occur following strabismus surgery, with a focus on identifying the type and timing of refractive shifts (such as myopia, hyperopia, or astigmatism) and their association with the type of strabismus and surgical technique used.


Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed with concomitant strabismus requiring surgical correction.
* Clear ocular media.

Exclusion Criteria:

* Patients with significant ocular pathology (e.g., cataracts, glaucoma,posterior segment pathology).
* Patients who have undergone previous intraocular or strabismus surgeries.
The Value of 68Ga-grazytracer PET in Monitoring Responses to Immunotherapy of Advanced Hepatobiliary Malignancy

This study aims to investigate the value of 68Ga-grazytracer in predicting the efficacy of immunotherapy for advanced hepatobiliary malignancies.

The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. All participants will undergo a 68Ga-grazytracer PET/CT after 3 cycles of immunotherapy to evaluate response. The imaging response measurements will be compared with the histopathological or clinical assessment results as gold standard.

Eligibility Criteria:
Inclusion Criteria:

1. Pathological and clinical diagnosis of advanced hepatobiliary malignancy requiring immunotherapy or combination immunotherapy after evaluation according to clinical guidelines
2. Signed and dated informed consent form
3. Commitment to comply with research procedures and co-operation in the implementation of the full research process
4. aged 18-75 years old
5. The patient is in good general condition with an expected survival of \&gt; 6 months

Exclusion Criteria:

1. Patients with serious illnesses that researchers consider unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
2. Intestinal perforation, complete intestinal obstruction
3. Uncontrolled diabetes patients or fasting blood glucose levels ≥11 mmol/L on the day of the trial
4. Pregnant women and women who may be pregnant, women who are breastfeeding.
5. Non-compliant person
Oral Drug Study In Women With Refractory Metastatic Breast Cancer After First-line or Second-line Herceptin.

The purpose of this study is to determine the efficacy of an oral investigational drug for the treatment of metastatic breast cancer tumors that are known to overexpress HER2/neu.


Eligibility Criteria:
Inclusion Criteria: (The patient must meet the following criteria in order to be eligible for this study.)

* Signed informed consent
* No more than two prior regimens for metastatic breast cancer. Each regimen must have contained Herceptin.
* Refractory Stage IIIb or IV breast cancer
* HER2/neu tumor overexpression
* Disease progression while receiving a prior chemotherapy regimen with Herceptin alone or in combination with other chemotherapy.
* Tumor tissue available for testing.
* 2 weeks since treatment with Herceptin (alone or in combination).
* Able to swallow and retain oral medication
* Cardiac ejection fraction within the institutional range of normal as measured by MUGA (Multiple Gated Acquisition Scan).
* Adequate kidney and liver function
* Adequate bone marrow function

Exclusion Criteria: (The patient cannot meet any of the following criteria in order to be eligible for this study.)

* Prior regimens did not include Herceptin.
* Pregnant or lactating.
* Conditions that would affect absorption of an oral drug
* Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent.
* Severe cardiovascular disease or cardiac disease requiring a device.
* Active infection.
* Brain metastases.
* Concurrent cancer therapy or investigational therapy.
* Use of oral or IV steroids.
* Unresolved or unstable serious toxicity from prior therapy.
* Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor other than Herceptin.
Safety and Tolerability of 200mg and 100mg of Venofer Administered to Hemodialysis(HD) Patients

The Objective of this study is to assess the Safety and Tolerability of 200 mg and 100 mg of Venofer Administered to Hemodialysis(HD) Patients.

This is a randomized open label multi-center study of two parallel patient groups undergoing hemodialysis. Group A will receive 200 mg of iron sucrose, while Group B will receive 100 mg of iron sucrose during the study. The duration of the study for each patient will be approximately 3 weeks including a screening phase, a treatment visit and a follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Males or females over 18 years of age and able to give informed consent.
* Undergoing hemodialysis.
* If receiving epoetin α, then the dose was stable.
* Percentage serum transferrin saturation (TSAT) \<50% and serum ferritin \<800 ng/mL.
* Absence of infection, malignancy, or surgery in the month prior to study start.
* Intolerance of other iron products did not preclude participation in this study.

Exclusion Criteria:

* Known sensitivity to any component of Venofer®.
* Suffering from concomitant severe diseases of the liver, cardiovascular system, severe psychiatric disorders or other conditions which, in the opinion of the investigator, made participation unacceptable.
* Serious bacterial, viral infection, or other acute infectious illness (e.g., hepatitis) unless completely resolved at least 4 weeks prior to inclusion in the study.
* Pregnancy or lactation.
* HIV positive by medical history or laboratory test (optional), or active hepatitis.
* Anemia caused by diseases (including systemic lupus erythematosus (SLE), rheumatoid arthritis, myeloma, or hereditary hemoglobinopathies) other than chronic renal failure or iron deficiency.
* Asthma.
* Clinical evidence of gastrointestinal bleeding.
* Would probably require blood transfusion or might undergo a renal transplant during the study.
* Anticipated surgery of any kind during the study other than vascular access surgery.
* Received an investigational drug within 30 days prior to screening.
* Previously participated in another Venofer® study.