cyrilzakka/clinical-trials huggingface dataset:
Epidemiology of Sexually Transmitted Infections and Its iMpAcT on fEmale Infertility

A longitudinal study to investigate the prevalence of sexually transmitted infections among young women and determine the role of the female genital tract microbiome in fertility


Eligibility Criteria:
Inclusion Criteria:

* 18-22 years
* informed consent

Exclusion Criteria:

* pregnancy
* sterilization
* not capable of giving informed consent
Induction Preoperative Chemotherapy for Patients With Locally Advanced Triple Negative Breast Cancer

The purpose of this study is to increase survival of patients with locally advanced triple-negative breast cancer using two consequent induction preoperative chemotherapy regimens.

Compared to other breast cancer subtypes, patients with triple-negative breast cancer have a lower recurrence-free and overall survival, regardless of disease stage at diagnosis. That's why new approaches to treatment of this aggressive breast cancer subtype are extremely anticipated.

One of the ways to improve the results of treatment of locally advanced triple-negative breast cancer is intensification of induction preoperative chemotherapy regimens. Elevation of the rate of pathological complete responses after completion of intensification induction preoperative chemotherapy enables to decrease the stage and increase survival of this aggressive breast cancer subtype. We hope to achieve more clinical and pathological treatment responses than with standard chemotherapy regimens and therefore to improve treatment outcomes of this extremely adverse group of patients.

Eligibility Criteria:
Inclusion Criteria:

* Female patients, age ≥18 years≤75
* Histologically confirmed invasive ER-, PR-, and HER2-negative (triple-negative) adenocarcinoma of the breast
* Stages Т2-4 N 2-3 M0
* Signed inform consent

Exclusion Criteria:

* Previous treatment for this breast cancer
* History of malignancy treated with curative intent within the previous 5 years with the exception of skin cancer, cervical carcinoma in situ, or follicular thyroid cancer. Patients with previous invasive cancers (including breast cancer) are eligible if the treatment was completed more than 5 years prior to initiating current study treatment, and there is no evidence of recurrent disease
* Pregnancy or breast-feeding
* Serious concurrent diseases or conditions that may alter chemotherapy conduction
AT247, NovoRapid® and Fiasp® in Glucose Clamp Study

A Phase I, randomised, single-centre, double-blind, single-dose, three period, balanced cross over study in a glucose clamp setting. The study compares the pharmacodynamic, pharmacokinetic and safety characteristics of AT247, NovoRapid® and Fiasp® in male participants with type I diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria include:

1. Diagnosis type I Diabetes Mellitus for at least 12 months
2. Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months
3. Fasting C-peptide concentration ≤8.5% (≤69 mmol/mol) at screening
4. BMI 18.5-35.0 kg/m2

Exclusion Criteria include:

1. known or suspected hypersensitivity to Investigational Medicinal Products
2. clinically significant concomitant disease or abnormal lab values
3. supine systolic BP outside range 95-140 mmHg and/or diastolic BP greater than 90 mmHg
Entamoeba Gingivalis and Periodontal Disease

This current study aims to clarify the relationship between the occurrence of Entamoeba gingivalis infection and the specter of gingivitis \& chronic periodontitis among Egyptian patients in comparison to healthy volunteers as a control group.

Three groups will be included in the current study. 40 Plaque samples will be collected from gingivitis patients (group 1), 40 from chronic periodontitis patients (group 2) plus 40 samples from healthy volunteers (group 3). Diagnosis of parasitic stages will rely on direct microscopic detection using permanent stains, Trichrome stain and haematoxylin and eosin stain in addition to direct wet mount examination.

Eligibility Criteria:
Inclusion Criteria:

* Chronic Gingivitis patients with signs of clinical inflammation with no clinical attachment loss.
* Chronic Periodontitis patients having probing depth of ≥3 mm and clinical attachment level ≥ 1 mm.
* The control group: healthy subjects who attend the restorative dental clinic and had clinically healthy gingiva.

Exclusion Criteria:

* Patients with any systemic diseases
Oral and Vaginal Misoprostol for Induction of Labor in Nulliparous Pregnant Women

The aim of this study is to compare the efficacy and the safety of vaginal misoprostol with oral misoprostol for induction of labor in nulliparous pregnant women at or beyond completed 41 weeks.

Induction of labor is carried out for maternal and fetal indications and one of the most common indications is prolonged pregnancy.

Recent studies have suggested that by continuing pregnancy beyond 41 weeks, there is statistically significantly higher perinatal morbidity and mortality as well as an increased risk to the mother. Thus, there is a growing body of evidence suggesting the elective induction of labor at 41 weeks of gestation instead of expectant management.

Misoprostol, a prostaglandin E1 analog, is indicated for protection against gastric ulcers, but when administered prenatally it causes uterine contractions. Research exploiting this adverse effect has shown misoprostol to be superior to conventional methods for induction, resulting in shorter induction-to-delivery intervals, without any increase in adverse outcomes. It has the advantage of being cheap, stable at room temperature, and easy to be administered by various routes i.e., vaginal, oral, sublingual, or rectal.

The differential outcomes of oral versus vaginal misoprostol may be secondary to different pharmacokinetics for oral compared with vaginal misoprostol. Oral misoprostol undergoes rapid absorption from the gastrointestinal tract and rapid and extensive de-esterification during first-pass metabolism to an active metabolite, misoprostol, peaking at 15 minutes with a half-life of 20-40 minutes. Misoprostol then undergoes early rapid elimination over 120 minutes, followed by slow elimination thereafter. The medication rapidly makes its way to the myometrium. ln contrast, after vaginal misoprostol administration, plasma concentration gradually increase, reaching a maximum level after 70-80 minutes before slowly being eliminated with plasma levels still detectable 6 hours after administration.

Eligibility Criteria:
Inclusion Criteria:

1. Maternal age: 18-40.
2. Nullipara: a woman who has never completed a pregnancy beyond 20 weeks gestation. She may not have been pregnant or may have had a spontaneous or elective abortion(s) or an ectopic pregnancy.
3. Single living pregnancy.
4. Gestational age: at or beyond completed 41 weeks (confirmed by a reliable date for the last menstrual period, regular cycle, or/and 1st trimesteric ultrasound scan).
5. Cephalic presentation.
6. Bishop score of 6 or less.
7. Reactive fetal non-stress test (NST).

Exclusion Criteria:

1. Any maternal chronic diseases or pregnancy-induced medical disorders.
2. Fetal anomalies.
3. Fetal macrosomia (\>4 Kg).
4. Intrauterine Growth Restriction (IUGR) (EFW below the 10th percentile for gestational age).
5. Rupture of membranes or oligohydramnios (AFI \< the fifth percentile).
6. Previous uterine scar.
7. Regular uterine contractions.
8. Any contraindication to vaginal delivery e.g., placenta previa (complete or partial covering of the internal os of the cervix with the placenta).
Platelet Count, Platelet, Mean Platelet Volume and Platelet Distribution Width in COVID-19

The study will aim to investigate the relation of platelet count (PLT), mean platelet volume (MPV) and platelet distribution width (PDW) with other acute phase reactant c-reactive protein(CRP) in Coronavirus(COVID-19).

As a methodology, patients will be selected in records in one month from the online hospital system. Two groups will be divided before as need for mechanical ventilation or not. The latter comparison will be about three groups as an ambulatory follow-up, hospital follow-up, and intensive care unit follow-up. Parameters will be analyzed according to the groups.

In this study, as a methodology, patients diagnosed with PCR test through the online system created for COVID-19 patients will be included in the study. These patients will be divided into 3 groups as outpatient follow-up, hospital follow-up and follow-up with a mechanical ventilator in intensive care. In addition, patients who have completed the 14-day treatment period, which is considered as the turning point time of the world health organization by looking at the patients 3 times, every 5-7 days, which is the accepted incubation period, will be included in the study. In these patients, hemoglobin, leukocyte, platelet, MPV, PDW and CRP values will be examined for 3 weekly measurements. Changes in COVID-19 disease follow-up and treatment of MPV and PDW values, which have not been studied so far, will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with COVID-19, both PCR tests and computed tomography, as well as control hemogram and CRP tests at one week intervals will be included.

Exclusion Criteria:

* Those with suspicion of COVID-19, those who do not perform hemogram and c-reactive protein tests 3 times with one week intervals, those who do not have standard drug treatment will be excluded from the study.
A Study of Eltrekibart (LY3041658) in Adult Participants With Moderate to Severe Hidradenitis Suppurativa

This study aims to find the appropriately safe and effective dose and dosing frequency for eltrekibart in adults with moderate-to-severe hidradenitis suppurativa (HS) for further clinical development. The study will last approximately 62 weeks and may include up to 31 visits.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of HS for at least 12 months.
* Have HS lesions in at least 2 distinct anatomical regions. At least 1 of the lesions must be at least Hurley Stage II or III.
* Have an (abscess plus inflammatory nodule) count of at least 5.
* Agree to use topical antiseptics daily.
* Had an inadequate response or intolerance to a 28-day course of oral antibiotics.

Exclusion Criteria:

* Have more than 20 draining fistulae.
* Have had surgical treatment for HS in the last 4 weeks before randomization.
* Have an active skin disease or condition, that could interfere with the assessment of HS.
* Have a current or recent acute, active infection.
* Are immunocompromised.
* Have a history of chronic alcohol abuse, IV drug abuse, or other illicit drug abuse within 1 year before screening.
Biomarkers of Benzene Exposure in Inner City Residents

This study compares air pollution exposures of residents in a South Baltimore community next to major industry with those in a comparison community with much less industry nearby. Parents and children as well as adults alone will be included. Air levels of 3 chemicals that have been found in increased amounts in the community as well as two urinary breakdown products of benzene will be measured. Participants will limit the amount of sorbate preserved foods they eat as this preservative interferes with one of the benzene breakdown products. Benzene air and urine exposure measurements will be compared in each community as well as between communities. By including children and parents we will gather exposure information on children who may be more sensitive that adults to these types of pollution. Lastly, by restricting the amount of food preserved with sorbates, we can decide if this improves the use of ttMA for people exposed to benzene from air pollution.

The current study focuses on an environmental exposure assessment of a South Baltimore community residing near a heavily industrialized area. Exposure differences between this community and a reference community that is demographically similar to South Baltimore but has limited industrial impact will be assessed. Participants will include both parent child study pairs and adults. Outdoor, indoor and personal 72 hour badge monitoring for benzene, 1,3-butadiene and carbon tetrachloride will be performed. Two urinary biomarkers for benzene exposure, trans,trans-muconic acid (ttMA) and s-phenylmercapturic acid (S-PMA) will be measured at 3 daily time points over the 3 day period. Past work indicates that ingestion of sorbate preserved foods causes substantial interference with the benzene biomarker, ttMA. Therefore, participants will restrict their intake of sorbate preserved foods during the study. On the day of greatest dietary restriction, a 24 hour benzene personal air measurement will be obtained. Data analysis will include correlations of benzene badge exposure measurements and urinary biomarkers. Air and biomarker benzene exposure data will be compared between communities. Linear regression modeling will be used to determine important explanatory factors of the biomarkers. The inclusion of parent child study pairs will also allow correlation of benzene air levels and urinary biomarkers between parents and children. This will provide exposure information on a potentially susceptible subpopulation, e.g. children, and allow assessment of potential for age-related differences in benzene metabolism. Finally, we will be able to determine if dietary restriction is practical and results in greater specificity of ttMA as a benzene biomarker.

Eligibility Criteria:
residence in one of the study communities
G3P-01 in Volunteers With Elevated Galectin-3

G3P-01 is an investigational pectin extracted, enriched and purified from commercial squash puree intended for human consumption. Pectins are an important constituent of fruits and vegetables, and health benefits are attributed to its intake. Some of the health benefits of pectins are attributed to inhibition of galectin-3. This study investigates if 30-days of G3P-01 intake in individuals with elevated galectin-3 induces biomarker changes that can be attributed to target engagement. Participants will be randomized into four groups (placebo, 100mg, 250mg and 1000mg G3P-01).


Eligibility Criteria:
Inclusion Criteria:

* Invited through cohort study.
* Plasma galectin-3 level of 16 ng/mL or higher
* Male and female subjects ≥45 and ≤75 years of age
* Females will be non-pregnant, non-lactating, and have no intent to become pregnant during the study period.
* Able to participate in the study in the opinion of the Investigator.
* Has the ability to understand the requirements of the study and is willing to comply with all study procedures.
* An Independent Ethics Committee or in Dutch Medisch- Ethische Toetsingscommissie (METC) -approved informed consent is signed and dated prior to any study-related activities.

Exclusion Criteria:

* Existing clinically significant concurrent medical condition which in the opinion of the Investigator may interfere with the study.
* Clinically significant abnormal laboratory test values, as determined by the Investigator, at Screening.
* Participation in a clinical trial of an investigational drug within 30 days prior to Screening, or is currently participating in another trial of an investigational drug, supplement or device.
Cognitive Behavioral and Faith Fellowship to Improve Thy Health

Investigators will examine the efficacy of a faith-based depression intervention, in reducing symptoms of depression among African American adults in Wisconsin. Twelve church groups, each with 10 people (N=120) will be invited to participate. This intervention will be the first evidence-based, faith-based intervention designed for African Americans if validated.

The randomized stepped wedge design (R-SWD) is a type of cluster randomized controlled trial in which the unit of randomization is a cluster (e.g., church groups with a group of 10 participants), not individual participants. At the start of a R-SWD, all clusters begin as control groups. At certain time points during the course of the trial, some of the clusters are randomly selected to be switched to the Cognitive Behavioral Faith Fellowship to Improve Thy Health (CB-FAITH) treatment, with all clusters eventually crossing over to receive the treatment.

Primary Aim 1: Examine efficacy of CB-FAITH in reducing symptoms of depression.

Secondary Aim 1: Examine moderating effects of religiosity on treatment effectiveness.

Secondary Aim 2: Evaluate satisfaction with CB-FAITH delivered in church settings.

Impact: CB-FAITH is poised to be the first evidence-based faith-based depression intervention designed for African American adults with depression. This community-prioritized research and transformative intervention has potential to reduce depression symptoms, reduce mental health disparities and advance health equity. Given the impact of COVID-19 pandemic, CB-FAITH is critically needed.

Eligibility Criteria:
Inclusion Criteria:

* self-identify as an African American man or woman
* are ages 18 and older
* have symptoms of major depressive disorder, as evidenced by score of 10 and higher from the Patient Health Questionnaire-9 (PHQ-9).

Exclusion Criteria:

* major psychotic illnesses, such as schizophrenia;
* current participation in psychotherapy
* current suicidal ideations (trained staff will conduct a suicide risk assessment and facilitate referral for appropriate care).
* Medication stabilization. Eligible participants who report recent changes to their psychiatric medications (i.e., initiation of a new medication, change in dose or type of medication) will delay their study enrollment for a stabilization period of 4 weeks. Baseline data collection will be re-administered
* alcohol or drug dependence - those with alcohol or other drug dependence who have been clean and sober for 3 months will not be excluded
Preemptive Oral Gabapentin and Tramadol on Postoperative Pain After Knee Arthroscopy

The aim of this study to evaluate the effect of preemptive oral gabapentin versus tramadol on postoperative pain after knee arthroscopy under spinal anesthesia.

Orthopedic surgeries are frequently associated with moderate-to-severe postoperative pain that can decrease mobility in the immediate postoperative period, interfere with postoperative rehabilitation, and delay hospital discharge. Pain may also become chronic.

Spinal anesthesia is the most popular anesthesia technique worldwide in orthopedic lower limb surgeries. However, its relatively short duration of action may limit the excellent postoperative analgesic effect. Thus, many adjuvants had been used to improve postoperative analgesia and decrease consumption of postoperative analgesics.

Gabapentin is a gamma aminobutyric acid analogue that is known as an anticonvulsant drug. This drug is tolerated well and has known effects on pain and anxiety.

Tramadol, a commonly used postoperative analgesic, is a synthetic centrally acting opioid analgesic. The various actions include inhibition of noradrenaline and serotonin reuptake, and also inhibition of M1 and M3 muscarinic receptors

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years old.
* Both sexes. American Society of Anesthesiologists (ASA) physical status I and II
* Undergoing knee arthroscopy procedures.
* under spinal anesthesia.

Exclusion Criteria:

* Cardiac patients.
* Patients with known allergy to drug of study.
* Prolonged administration of NSAIDS or other analgesics due to chronic pain of any reason.
* Cirrhosis.
Evaluation Of Cloumella Strut Effect In Tip Rotation

The role of strut in rhinoplasty has been debated for many years and many research has been made over this problem but there is no significant data for descision of surgeon, so this study was designed to evaluate the effect of columellar strut in tip projection and rotation.

In selected case of rhinoplasty use strut randomly and blindly evalute the effect of it in tip rotation and projection.

Eligibility Criteria:
Inclusion Criteria:

* RHINOPLASTIC PATIENTS

Exclusion Criteria:

* REVISION SURGERY,
* INCOMPLETE STRIP,
* FACIAL ANOMALY
Donor-Derived Cell-free DNA to DETect REjection in Cardiac Transplantation

The study objective is to demonstrate that rejection surveillance of heart transplant recipients with Prospera dd-cfDNA is non-inferior to rejection surveillance with endomyocardial biopsy and histology in the first post-transplant year.

Subjects will be enrolled into the study while on the transplant waiting list prior to heart transplantation. All subjects will follow the center's standard of care surveillance schedule from transplant through 4 weeks post-transplantation. EMB during this phase is expected to occur roughly weekly.

Subjects will be randomized in a 1:1 ratio 30 days (± 7 days) post-transplant to Prospera surveillance (Study Group) versus EMB surveillance (Control Group, standard clinical care). Rejection surveillance (Prospera testing in the Study Group and EMB in the Control Group) will be performed at times corresponding to the institutional standard of care schedule for rejection surveillance.

Study Group: Prospera Surveillance (300 Subjects) Subjects will undergo Prospera testing at times corresponding to the institution's graft surveillance schedule. Prospera test results will be provided to the clinical team. Prospera cfDNA level \< 0.15% will be interpreted as negative and a surveillance EMB will be omitted. Prospera cfDNA ≥ 0.15% will be followed by EMB. A for-cause EMB can be done per the clinical team's discretion at any time.

Control Group: EMB Surveillance (standard of care) (300 Subjects) Subjects will undergo surveillance EMB per the institution's standard clinical care.

The study intervention will be during the first 12 months post-transplant.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, age 18 years or older at the time of signing informed consent.
2. On the heart transplant waiting list and expected to receive a heart transplant.
3. Able to read, understand and provide written informed consent.
4. Able and willing to comply with the study visit schedule, study procedures and study requirements.

Exclusion Criteria:

1. Heart transplantation has been performed.
2. Concurrent multiple solid organ or tissue transplant
3. Prior history of any organ or cellular transplantation.
4. Planned use of other commercially available or investigational cfDNA or gene expression profile assays.
5. Pregnant.
6. Hemodynamically unstable or other serious medical condition that may adversely affect the subject's ability to participate in the study