cyrilzakka/clinical-trials huggingface dataset:
Optimal Interval Between Consecutive Cesarean Sections

The goal of this observational study is to determine the best time interval between consecutive cesarean sections and compare maternal and neonatal outcomes in women with a history of previous cesarean sections. The main questions it aims to answer are:

* What is the optimal time interval between consecutive cesarean sections for minimizing maternal intraoperative complications, blood transfusions, and intra- and postoperative bleeding?
* What are the differences in fetal and neonatal outcomes based on different time intervals between cesarean sections?

Participants will be divided into five subgroups based on the time interval since their last cesarean section: 0-12 months, 12-24 months, 25-36 months, 37-48 months, and more than 48 months. Each participant will undergo an elective cesarean section and provide data on maternal and neonatal outcomes.

Researchers will compare these subgroups to see if varying time intervals between consecutive cesarean sections affect maternal and neonatal outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20-40 years.
* Full-term pregnant women more than 37 weeks gestation.
* Women with a history of at least one previous cesarean section, planning an elective repeated cesarean section.

Exclusion Criteria:

* Women with contraindications to cesarean section
* Those with emergency indications
* Multiple pregnancies
* Pre-existing maternal or fetal conditions affecting outcomes.
Primary Vaccination With Either Synflorix™ or Prevenar 13™ or Both Vaccines and Booster Vaccination With Synflorix™

The primary aim of this study is to assess the reactogenicity of Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. In addition, this study aims at assessing the safety, reactogenicity, immunogenicity and antibody persistence (approximately 8-11 months following primary vaccination) of the Synflorix vaccine and Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. This study also aims at assessing the safety, reactogenicity and immunogenicity of the Synflorix vaccine when given as a booster dose at 12-15 months of age following primary vaccination at 2 and 4 months of age with either Synflorix vaccine or Prevenar 13 vaccine or Prevenar 13 and Synflorix respectively.

This study is partially blinded as the primary phase will be conducted in an observer-blind method and booster phase will be open method.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that parent(s)/Legally Acceptable Representative(s) \[LAR(s)\] can and will comply with the requirements of the protocol.
* A male or female between, and including, 6-12 weeks of age at the time of the first vaccination.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Born after a gestation period of at least 36 weeks.
* Written informed consent obtained from the parent(s)/LAR(s) of the subject.

Exclusion Criteria:

* Child in care.
* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccines, or planned use during the entire study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs since birth or planned use during the study.
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine.
* Major congenital defects or serious chronic illness.
* History of any seizures or progressive neurological disease.
* Administration of immunoglobulins and/or blood products since birth or planned use during the study.
* Acute disease and/or fever at the time of enrolment.
* Previous vaccination or planned vaccination during the study with any pneumococcal vaccine.
Remote Rehabilitation Via the Internet in Patients After a Stroke - Physical Rehabilitation Using Biofeedback Systems to Improve Upper Extremity Function

The objective of this study is to examine monitored rehabilitation therapy over the internet to improve upper limb function for stroke patients. Home rehabilitation for stroke patients will avoid the burden of arrival to the health facilities, making it easier on them and improve their quality of life and the lives of their caregivers. To achieve this goal the investigators will examine the effectiveness and feasibility of home rehabilitation system of upper limb, consisting of ergonomic accessories (hand and arm tutors).

The quantitative indices will be based on the quantitative clinical measures that are used in regular evaluations of stroke patients and function and range of motion indices as received from the system.


Eligibility Criteria:
Inclusion Criteria:

* Stroke patients who had at least eight conventional rehabilitation treatments lasted at least until a month before the start of the experiment,
* not affected cognitively (to be determined by the score on the mini mental exam greater than 23).
* patients have daily access to a computer and the Internet, and use a personal caregiver or family member can supervise the use of the system.

Exclusion Criteria:

* Global or sensory aphasia, unilateral spatial neglect, apraxia and other acute neurological or orthopedic conditions.
Collection of Blood in Studying Metabolites in Patients With Prostate Cancer

This pilot research trial utilizes the collection of blood in studying metabolites in patients with prostate cancer. Metabolites are the small molecule products of cellular metabolism that are produced naturally in all living cells. Collecting blood in order to study metabolites may help doctors monitor and treat prostate cancer more effectively.

PRIMARY OBJECTIVES:

I. Develop blood sample collection and preparation procedures for reliable, meaningful metabolomic profiling of peripheral blood mononuclear cells (PBMCs) by liquid chromatography/quadruple-time of flight/mass spectrometry (LC/Q-TOF/MS) that can be implemented in a clinical setting.

II. Optimize data analysis methods and software usage to create a metabolic profile for patients at the time of blood collection.

III. Compare metabolite profiles of isolated PBMCs versus (vs.) other blood fractions (plasma, red blood cells \[RBCs\], and whole blood).

IV. Identify elements of the PBMC metabolite profile that may correlate to patient disease state.

OUTLINE:

Patients undergo collection of blood for metabolic profiling via LC/Q-TOF/MS.

Eligibility Criteria:
Inclusion Criteria:

* All subjects will have histologically confirmed prostate cancer
* Provide written consent/authorization to participate in this study
* Have no signs or symptoms of active infection
* Exhibit a willingness to comply with the experimental procedures as outlined in this protocol
Expression Analysis of Urinary Exosome in Type 2 Diabetic Nephropathy and Evaluation of Its Clinical Diagnostic Value

Expression analysis of urinary exosome miR-142-3p in type 2 diabetic nephropathy and evaluation of its clinical diagnostic value

1. Preliminary screening of miRNAs: Through GEO database and reading related literature, miRNAs differentially expressed in type 2 diabetes and diabetic nephropathy were selected as potential candidate biomarkers for follow-up verification.
2. Collection and treatment of clinical samples: Urine of diabetic patients was collected from the First Affiliated Hospital of Shandong First Medical University in strict accordance with the drainage standard, and the basic information of patients was registered. Meanwhile, the collected samples were divided into type 2 diabetes group and diabetic nephropathy group according to whether the urine was accompanied by UACR≥30/g. Subsequently, the collected samples were centrifuged and retained for supernatant.
3. Isolation and identification of urinary exosomes: Ultrafast centrifugation method was used to separate the treated urine samples of exosomes, and then identified by transmission electron microscopy, nanoparticle analysis and Western blot respectively.
4. Real-time PCR was used to detect the changes in urinary exosomal miRNA expression levels of the two groups of patients, and statistical analysis and correlation analysis of clinical indicators of the differentially expressed mirnas were performed.

Target gene prediction and enrichment pathway analysis of differentially expressed mirnas were performed to screen out pathways that might be related to the occurrence and development of DKD, and then the relevant pathways were verified by immunofluorescence, immunocoprecipitate, Western blot, Real-time PCR and other methods.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old;
2. Previously diagnosed with type 2 diabetes;
3. Typical diabetic symptoms (polydipsia, polydipsia, polyuria and weight loss) plus random blood glucose ≥11.1mmol/l;
4. Fasting blood glucose ≥7.0mmol/l, fasting is defined as at least 8 hours without intake of calories;
5. Oral glucose tolerance test (OGTT) 2-hour blood glucose ≥11.1mmol/l, using a glucose load equivalent to 75 grams of anhydrous glucose dissolved in water (venous blood was drawn in all patients;
6. With or without UACR≥30mg/g.

Exclusion Criteria:

(1) Refused to enroll patients; （2）Type 1 diabetic nephropathy and other special types of diabetic nephropathy; （3）Patients with kidney stones and urinary system infection; （4）Patients with autoimmune system diseases, malignant tumors, and blood system diseases; （5）Patients with severe chronic cardiopulmonary disease, chronic liver and kidney disease; （6）Patients with severe infectious diseases; （7）Use of glucocorticoids, immunosuppressants or cytotoxic drugs.
'OLAP' (OLAparib Regulatory Post-marketing Surveillance)

The objectives of this study are to assess safety and effectiveness of Lynparza tablet (olaparib, hereinafter "the study drug") in a real world setting in patients who are prescribed with the study drug according to the approved indications in South Korea

Primary Objective: To assess the safety of the study drug for patients prescribed with the study drug under the approved indications in South Korea Secondary Objective: To assess effectiveness of the study drug for patients prescribed with the study drug under the approved indication in South Korea Exploratory Objective: To assess effectiveness of the study drug for ovarian cancer patients diagnosed as Homologous Recombination Deficiency (HRD) positive via locally available validated HRD test and prescribed with the study drug under the approved indication in South Korea

Eligibility Criteria:
Inclusion Criteria:

1. Eligible for the study drug treatment according to the approved label in South Korea
2. Provision of signed and dated written informed consent by the patient or legally acceptable representative

Exclusion Criteria:

1. History of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug
2. Prior exposure to any Polyadenosine 5'diphosphoribose polymerase (PARP) inhibitors, including the study drug
3. Pregnant and/or breast feeding
4. Current participation in any interventional trial
5. Other off-label indications according to the approved label
Evaluation of Next-Generation Sequencing-based Metabarcoding Versus Culturing for Microbiological Assessment in Infectious Keratitis

Infectious keratitis is a potential sight threatening condition. In conventional clinical practice culturing is performed in order to identify the causative microbial organism; however in recent years Next Generation Sequencing for the presence of ribosomal DNA from bacteria, fungi, or amoeba has become available. The present study aims to compare conventional culturing with Next Generation Sequencing for identifying microorganism causing keratitis.

Patients admitted with microbial keratitis to the department of ophthalmology at Aarhus University Hospital is evaluated with both conventional culturing at agar plates, broth culture, and Next Generation Sequencing for ribosomal DNA.

Only patients with a corneal infiltrate of a minimum of 2 mm or of 1 mm within the central 6 mm of the cornea will be included in the study.

Sampling includes two samples from the contralateral healthy eye to control for the patient's normal microbiome, evaluated with culturing in broth and with NGS.

From the infiltrate, samples include culturing on Sabouraud agar, chocolate agar, and blood agar, culturing in broth medium, and samples for NGS.

A total of 100 patients will be included.

Eligibility Criteria:
Inclusion Criteria:

- Patients with a corneal infiltrate of minimum 2 mm in diameter or of 1 mm diameter within the central 6 mm of the cornea

Exclusion Criteria:

- Patients below 18 years of age
Study of Clinical and Laboratory Variables Associated With a Direct Oral Anticoagulant Bioassay Higher Among Those Aged Over 75 Years

The objective of this study was to investigate whether there is a link between clinical and biological variables and bioassay high xaban in elderly patients as part of an unscheduled hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 75 years
* Entering SAU or MPG (Nantes University Hospital) as part of an unscheduled hospitalization for acute or subacute disease (About MPG, will be included patients admitted to the department within 48 hours of calling the doctor)
* In xaban to entry (dabigatran, rivaroxaban, Apixaban) for non-valvular atrial fibrillation
* In whom hemostasis tests will be prescribed as part of usual care
* Patient has given its verbal agreement

Exclusion criteria

Patients with the following criteria may not be included:

* Patients refusing to participate in the study
* Patients under guardianship
* Inability to obtain the date and time of the last dose of xaban
Prostate Cancer Patient Management With 18F-DCFPyL PET/CT

This is a multi-center, single-arm, open-label, phase III trial in patients with biopsy-proven prostate cancer. Patients will receive regular standard of clinical care. The only study-specific procedures will the administration of 18F-DCFPyL followed by a PET/CT scan. Differences in theoretical optimal clinical management based on a review of clinical, biochemical and radiographic subject data before and after 18F-DCFPyL PET/CT imaging by a central panel of experts will be captured at study completion.

Objectives: The primary objective of this study is to assess the differences in theoretical optimal clinical management afforded by 18F-DCFPyL PET/CT in prostate cancer patients as proposed by a central panel of experts.

Primary endpoint:

1. Differences in theoretical optimal clinical management based on a review of clinical, histopathological, biochemical and radiographic subject data both before and after 18F-DCFPyL PET/CT imaging retrospectively by a central panel of experts.

Secondary endpoints:

1. 18F-DCFPyL PET/CT scan positivity fraction in patients with biochemically recurrent prostate cancer, stratified by PSA.
2. Immediate AE up to 90 minutes post-administration of 18F-DCFPyL.

Eligibility Criteria:
Inclusion Criteria:

* Male sex
* Age 18 years or older
* Previously diagnosed with prostate cancer, under referring physician's care
* ECOG performance status 0 - 3, inclusive
* Able to understand and provide written informed consent
* Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 40 minutes and tolerating intravenous cannulation for injection

Cohort A - High risk staging (HRS): Staging of high risk not previously treated patients as defined by any one of the following:

* Gleason score \> 7
* Serum PSA \> 15 ng/ml
* T stage of T3 or greater on TNM staging
* Equivocal/inconclusive conventional staging such as CT, MRI or bone scan
* Clinical suspicion of advance stage disease (e.g. bone pain)

Cohort B - Biochemical recurrence: Restaging of biochemically recurrent prostate cancer patients as defined by increasing serum PSA on serial measurements and current PSA above 0.1 ng/ml following any treatment for prostate cancer.

Exclusion Criteria:

* Patients who are medically unstable (e.g. acute cardiac or respiratory distress or hypotensive)
* Patients who exceed the safe weight limit of the PET/CT bed (usually approximately 400 lbs.) or who cannot fit through the PET/CT bore (usually approximately 70 cm diameter)
* Patients with unmanageable claustrophobia
Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion

Minimally invasive (MIS) lumbar decompression and fusion is a new procedure that aims to reduce post-operative pain, opioid consumption and related side effects, and length of hospital stay. Current research demonstrates a modest improvement in these areas beginning on the third post-operative day. MIS fusion, however, incurs significant cost as the average time of the procedure is approximately one third greater (from 148 minutes to 191 on average). Epidural analgesia has clearly demonstrated benefits for conventional open laminectomy. In order to fully maximize the benefits of an MIS technique, early post-operative analgesia/pain must be improved. The aim of this study is to combine two techniques to ultimately improve patient outcomes and satisfaction. This will be a randomized trial involving 32 patients undergoing MIS decompression and fusion with half the study group receiving active epidural and IV-PCA and the other half receiving epidural placebo and IV-PCA.

The hypothesis is that epidural analgesia will reduce post-operative opioid consumption, improve pain scores, and decrease time to ambulation as well as discharge from hospital after MIS decompression and fusion.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled to undergo minimally invasive lumbar decompression and fusion at the Toronto Western Hospital
* both genders
* ASA I to III
* BMI less than 35

Exclusion Criteria:

* refuses treatment randomization
* inability to give informed consent
* language barrier
* local anesthetic allergy
* allergy to shellfish or eggs
* bleeding diathesis
* sickle cell disease or trait
* pregnancy
* drug addiction
* psychiatric history
* severe intercurrent illness (ASA IV or V)
* patients requiring anesthesia of other surgical sites
Effects of a Health Workforce Capacity Building and Quality Improvement Intervention in Kinshasa

The aim of the study is to evaluate a health workforce capacity building and quality improvement intervention focused on integrated day-of-birth and post-pregnancy care at 16 hospitals in Kinshasa, Democratic Republic of Congo. The intervention package consists of a low-dose, high-frequency (LDHF) training of health workers, support for quality improvement teams, and provision of critical equipment, supplies and drugs within a quality improvement (QI) framework.

The health workforce capacity building and quality improvement intervention will be implemented in two phases: eight facilities will receive the intervention in phase 1 and the remaining eight facilities will receive the intervention in phase 2.

Objective 1: For objective 2 on facility-based health outcomes, the study design is a cluster-randomized evaluation in phase 1. The intervention's effects will be assessed by comparing an intervention group and a control group of facilities. These will be selected from 16 Kinshasa health facilities. Intervention and control facilities' monthly reported health outcomes will be compared in a 12-month baseline period and 12-month period during and after the intervention implementation (Phase 1) in a difference-in-difference analysis. In Phase 2, all facilities will have their monthly service statistics and health outcomes reviewed for trends in improvement.

Overall, in Phase 1, eight intervention sites will be matched to eight sites serving as controls. In Phase 2, the eight Phase 1 control sites will then receive the same package as the intervention sites in Phase 1. Sites will be stratified by case load, low and high (over 90 births per month), and funding (public or private funding). Within each stratum, prior to start of the intervention, there will be random selection to intervention and control groups to allow for baseline comparability between groups.

Eligibility Criteria:
Inclusion Criteria:

* Health providers:

  * Currently on the roster of maternity ward providers working at one of the 16 selected facilities at the time of the training module.
  * Willing to attend a Jhpiego clinical training workshop and offer consent as study participant.
  * Age 18 or older.

Exclusion Criteria:

* there are no exclusion criteria
A Study to Evaluate Retisert in the Treatment of Patients With the "Wet" Form of Age-Related Macular Degeneration

A study evaluating Retisert in patients with age-related macular degeneration


Eligibility Criteria:
KeraStat(R) Cream for Radiation Dermatitis

The primary objectives of the proposed research are to evaluate patient use of KeraStat Cream and collect data to inform a larger future trial.

The primary objectives of the proposed research are to evaluate patient use of KeraStat Cream and collect data to inform a larger future trial.

The secondary objectives are to assess the safety and tolerability of KeraStat Cream in subjects at risk of radiation dermatitis, to assess the effectiveness of KeraStat Cream and how that compares to the current standard of care, and to estimate the amount of KeraStat Cream used per patient and coverage on skin.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 to 70
2. Female
3. Diagnosis of breast cancer and scheduled to receive 4 to 6 weeks of radiation therapy (radiation dose of 42 Gy or more)
4. Able and willing to sign protocol consent form
5. Able and willing to document symptoms and treatment details as often as needed, not to exceed daily notes
6. Able and willing to have photographs of the affected area taken regularly

Exclusion Criteria:

1. Women who are pregnant, lactating/nursing or plan to become pregnant
2. Previous radiation therapy to the area to be treated with radiation therapy
3. Receiving palliative radiation therapy
4. Unhealed or infected surgical sites in the irradiation area
5. Patients undergoing cytotoxic chemotherapy or concurrent Herceptin as part of overall treatment plan (tamoxifen/aromatase inhibitor allowed)
6. Use of oral corticosteroids or topical corticosteroids in the irradiation area
7. Autoimmune disease
8. Skin disease in target irradiation area
9. Known allergy to the standard of care or ingredients in KeraStat Cream