cyrilzakka/clinical-trials huggingface dataset:
Clinical Evaluation of the Click Sexual Health Test for the Detection of Neisseria Gonorrhoeae (NG), Trichomonas Vaginalis (TV), and Chlamydia Trachomatis (CT) in Women

This study is a multi-center study with a minimum of three CLIA-waived intended operator sites in the United States in which prospectively self-collected vaginal specimens obtained from subjects who are symptomatic or asymptomatic for CT, NG, or TV will be evaluated with the Click Sexual Health Test in a Clinical Laboratory Improvement Amendments (CLIA) waived setting. Subjects interested in participating in this study will be assessed for eligibility and asked to give informed consent and assent, if applicable, by the Investigational Review Board (IRB). Only those subjects who meet the inclusion and exclusion criteria may be enrolled in the study.


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to give voluntary written informed consent and assent form (or the parental/legal guardian will provide parental permission) before any study-related procedure is performed.
2. Female at birth. (Pregnant and breastfeeding women are eligible).
3. Age greater than or equal to 14 years at the time of enrollment
4. Able to read and understand the procedural information provided for the study.
5. Able and willing to follow all study procedures, including performing self-collection of one vaginal swab and permitting a HCP to collect three additional vaginal swabs.

Exclusion Criteria:

1. Have a medical condition, serious intercurrent illness, or other circumstance that, in the Investigator's judgement, could jeopardize the subjects's safety, or could interfere with study procedures.
2. Enrollment in the DMID 18-0024 and this study previously.
3. Use of antiperspirants and deodorants or the following vaginal products: douches, washes, lubricants, vaginal wipes, vaginal moisturizers, or feminine hygiene spray in the genital area, within 48 hours prior to enrollment.
Safety and Efficacy of Desferasirox in Chinese Patients With Iron Overload and Aplastic Anemia

The study is designed to collect safety and efficacy of Desferasirox in Chinese patients with Iron Overload and Aplastic Anemia.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting with transfusion-related IOL as shown by a SF level of ≥ 1000 ng/mL at start of study
* History of transfusion \>20 international units or 100 mL/kg of red blood cells
* Underlying transfusion-dependent illness:

  * AA: Clinically diagnosed AA with bone marrow confirmation of the diagnosis
* Age ≥ 18 years, male or female
* Written informed consent obtained from patient prior to any screening procedures.

Exclusion Criteria:

* Patients with serum creatinine \> ULN or with significant proteinuria as indicated by a urinary protein/creatinine ratio (UPCR) ≥ 1.0 mg/mg in a non-first void urine sample at baseline. If serum creatinine is found to be \> ULN or UPCR is found to be ≥ 1 mg/mg the test can be repeated after 1 month.
* Creatinine Clearance \<40 ml/min
* Patients with other than AA transfusion-dependent underlying illnesses
* Patients with a previous history of clinically relevant ocular and/or auditory toxicity related to iron chelation
* Any other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug. The investigator should be guided by evidence of any of the following:
* history of inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding
* history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
* history of pancreatic injury or pancreatitis; indications of impaired pancreatic function/injury as indicated by abnormal lipase or amylase
* history or presence of impaired renal function as indicated by creatinine or blood urea nitrogen (BUN) values equal or above ULN
* history of urinary obstruction or difficulty in voiding

Other protocol-defined inclusion/exclusion criteria may apply
Randomized Trial of Enteral Vitamin D Supplementation in Infants < 28 Weeks Gestational Age or <1000 Grams Birth Weight

The objective of the study is to compare supplementation with vitamin D at 800 IU/day to usual care for the first 28 days after birth with respect to 25 (OH) vitamin D levels and indicators of likely or plausible effects of vitamin D supplementation on the function or structure of the lung, bones, immune system, and brain in extremely premature (EP) infants who are \<28 weeks gestational age (GA) or \<1000 grams of birth weight (BW). The study results will be analyzed as intention to treat Bayesian analyses (Frequentist analyses will also be performed).


Eligibility Criteria:
Inclusion Criteria:

* Infants born at \< 28 weeks gestational age (GA) or \<1000 grams birth weight (BW)
* Inborn
* Informed written consent in an Institutional Review Board (IRB)-approved manner

Exclusion Criteria:

* GA \>32 weeks regardless of birth weight (BW)
* Any major congenital anomaly
* An known congenital nonbacterial infection
* Prenatal diagnosis of disorders that affect vitamin D absorption (e.g, cystic fibrosis)
* Such severe illness or immaturity that the attending neonatologist judges intensive care to be unjustified.
Role of Chronic Endometritis in Postoperative Recurrence of Severe Intrauterine Adhesions

This study is to evaluate the prevalence of chronic endometritis (CE) in women with severe intrauterine adhesions and compare recurrence of adhesion in women with and without CE.

Chronic endometritis (CE) is a persistent in endometrium that is characterized by the presence of plasma cells. Recently, there has been increasing interest in the role of CE in recurrent pregnancy loss (RPL). One of the most common uterine abnormalities for RPL is Intrauterine adhesion (IUA).Intrauterine adhesion, also known as Asherman's syndrome, is the partial or complete occlusion of the uterine cavity as a result of endometrium damage. Most intrauterine adhesions patients manifest amenorrhea, reduced menstrual pattern, infertility, and intrauterine growth restriction, which seriously affect their reproductive health.It is well established that the formation of IUA likely involves hypoxia, reduced neovascularization, and altered expression of adhesion-associated cytokines, but the exact mechanisms are not well understood. Although excessive curettage is considered the primary cause, intrauterine adhesion is known to be associated with diverse non-traumatic factors, such as postabortal sepsis, puerperal sepsis and infections. It is therefore possible to hypothesize that Intrauterine adhesion may be related to chronic endometritis. To the best of researchers knowledge,there have been no reports investigating this relationship. The aim of this study was to clarify the hypothesis by evaluating the prevalence of chronic endometritis (CE) in women with severe intrauterine adhesions and compare recurrence of adhesion in women with and without chronic endometritis (CE).

Eligibility Criteria:
Inclusion Criteria:

* Pre-operative adhesion score was ≥5
* The prior menstrual cycle was regular, and the sex hormone was normal
* with informed consent
* absence of other uterine abnormality at transvaginal ultrasound
* There were no severe systemic diseases, and no contradictions to aspirin, estrogen and surgery.

Exclusion Criteria:

* Pre-operative adhesion score was \<5
* Prior menstrual cycle was irregular and sex hormone was abnormal, or patients had endocrine factors that caused amenorrhea, menstrual reduction and infertility
* other uterine abnormality at transvaginal ultrasound
* without informed consent
* Patients had contradictions to estrogen and aspirin such as cancers (breast cancer and endometrial cancer), thrombotic diseases, allergy to antipyretic analgesics, severe liver injury, hypoprothrombinemia, vitamin K deficiency, hemophilia, thrombocytopenia, gastric or duodenal ulcer and asthma
* refuse Endometrial biopsy
* Vaginal discharge abnormal, or Suspected vaginitis or pelvic inflammatory disease, or using antibiotics.
Effect of Normothermia Care Bundle in Knee Replacement Surgery

Osteoarthritis is a disease characterized by disruption of the integrity of articular cartilage as a result of erosion of articular cartilage. Knee osteoarthritis causes muscle weakness, crepitation and deformities in the knee joint, limiting the individual's movement and causing loss of function. The most prominent feature is pain. Therefore, knee replacement surgery is performed in advanced cases where pharmacologic treatment is not effective. Many complications can be seen during the operation process and some of them may occur due to hypothermia. Studies have reported that warming during the operation prevents hypothermia and reduces complications. In this study, it was aimed to examine the effect of active and passive heating applied before, during and after surgery on hypothermia, surgical site infections and bleeding. The population of the study will consist of patients who underwent knee replacement surgery in the Orthopedics and Traumatology Clinic of Üsküdar State Hospital between April 2024 and April 2025. Data will be collected using the patient identification form, normothermia care package observation form, preoperative follow-up form, postoperative follow-up form and postoperative long-term follow-up form. A randomization list generated from a computer-based random numbers table will be used to determine which group of patients will be included in the study. Patients will be followed up in 3 periods: preoperative, intraoperative and postoperative periods. The postoperative period will be evaluated in five stages as day 1, day 2, day 3, day 10 and day 30. The purpose of the study and the intervention to be applied will be explained to all groups to be included in the study by the researcher and written and verbal consent will be obtained from the volunteers. The groups included in the study will be subjected to the heating protocol according to the normothermia care package. Group A will receive active heating with the heating method using a hot air blowing device. Group B will receive passive heating using a reflective blanket. Group C was planned as a control group to be heated by applying the routine heating procedure of the hospital without any intervention. Body temperature and vital signs will be checked preoperatively and warming will be performed 30 minutes before surgery, and warming will be started 15 minutes before anesthesia induction during surgery and body temperature and vital signs will be checked. After the operation and in the ward, warming will be performed until the body temperature reaches 37 C°. The data obtained will be analyzed using SPSS (Statistical Package for Social Sciences) for Windows 22.0 program.


Eligibility Criteria:
Inclusion Criteria:

18 years or older Planned elective knee arthroplasty surgery Patients planned for neuraxial block anesthesia ASA (American Society of Anesthesiologists) class I-III

Exclusion Criteria:

Alcohol and drug addiction, Patients who cannot be contacted Preoperative body temperature \<36 C° or ≥37.5 C°
Lifestyle Intervention Program for Cognitive Impairment

The purpose of the Lifestyle Intervention Study is to investigate the influence of a micronutrient supplement in combination with a comprehensive lifestyle intervention program on retinal amyloid, among patients with Mild Cognitive Impairment (MCI). Patients will be placed on supplement or placebo throughout their 18-month study participation. Patients will also be given lifestyle training on nutrition, physical activity, cognitive and social activity, meditation and sleep, which have all been proven to positively affect cognition over time. Throughout their participation, patients' cognitive functioning will be monitored with comprehensive imaging, neuropsychological testing, blood testing and study compliance.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 55 years of age
* Experiencing memory, or cognitive problems

Exclusion Criteria:

* Patients \< 55 years of age
* Previously diagnosed dementia; suspected dementia after clinical assessment by study physician at screening visit
* Mini Mental State Examination (MMSE) score less than 20 points
* Disorders affecting safe engagement in the intervention (e.g., malignant disease, major depression, psychiatric disease, symptomatic cardiovascular disease, revascularization within 1 year previously)
* Unable to safely change diet
* Patients without the means to visit the clinic on the assigned dates
* Patients that cannot comply with the data gathering needs of the study
* Severe loss of vision, hearing, or communicative ability
* Disorders preventing cooperation as judged by the study physician
* Coincident participation in another intervention trial
* Allergy to any ingredient in the supplement or placebo (i.e. soybean oil)
* Patients with gallstones due to possible interactions with turmeric
* Participants who are unable to provide clearance from their physician to participate in the physical activity training, as well as confirmed by Dr. Sherzai during the neurological exam.
Prevalence of Sexual Dysfunction After Rectal Surgery and Patient Satisfaction of Preoperative Discussions

Sexual dysfunction after rectal surgery varies widely in the literature. Prevalence of sexual dysfunction before surgery and desire of patient to treat this condition is also not well established.

Objectives of this prospective cohort study were to determine prevalence of sexual dysfunction with a questionnaire before and after surgery. Patient's satisfaction and quality of life were also collected regarding preoperative information given.


Eligibility Criteria:
Inclusion Criteria:

* Male between 18 and 65 years old
* Will undergo one of the following surgeries in the 12 months after the initial visit:

  * Low anterior resection
  * Abdominoperineal resection with end colostomy
  * Total proctocolectomy with ileostomy
  * Total proctocolectomy with ileoanal reservoir
  * Proctectomy
* Having had a sexual intercourse in the 4 weeks prior to the initial visit
* Having the desire to maintain sexual activities in the post-operative period

Exclusion Criteria:

* Tadalafil allergy/hypersensitivity
* Having received treatment for erectile dysfunction or medical treatment in the 4 weeks prior to the initial visit
* Active consumption of nitrate derivatives (NO)
* History of non-arteritic ischemic optic neuropathy
* Severe renal or hepatic insufficiency
* Stroke in the last 6 months
* Myocardial infarction in the last 3 months
* Unstable angina pectoris or angina pectoris during sexual relations
* Cardiac insufficiency Class ≥ 2 in the last 6 months
* Uncontrolled arrhythmia, hypotension or hypertension
Observational Study of METALYSE® in Patients With Acute Myocardial Infarction In Russian Federation

Primary: To support the Regulatory Approval process of Metalyse® in Russian Federation. Secondary: To assess the efficacy and safety of single bolus of Metalyse® TNK-tissue plasminogen activator (TNK-tPA, Tenecteplase ) in patients with acute myocardial infarction in usual routine treatment after market launch


Eligibility Criteria:
Inclusion Criteria:

* onset of symptoms of AMI within 6 hours
* on a twelve-lead electrocardiogram (ECG), ST-segment elevation ≥ 0.1 millivolt (mV) in two or more limb leads, or \> 0.2 mV in two or more contiguous precordial leads indicative of AMI, or left bundle-branch block
* age ≥ 18

Exclusion Criteria:

* significant bleeding disorder at present or within the past 6 months, known hemorrhagic diathesis
* patients with current concomitant oral anticoagulant therapy with International Normalised Ratio (INR) \> 1.3
* any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)
* severe uncontrolled arterial hypertension (hypertension defined as blood pressure 180/110 mm Hg (systolic BP \> 180 mm Hg and/or diastolic BP \> 100 mm Hg) on one single reliable measurement during current admission prior to study enrolment
* major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with the current AMI), recent trauma to the head or cranium
* prolonged or traumatic cardiopulmonary resuscitation (\> 2 minutes) within the past 2 weeks
* severe hepatic dysfunction, including hepatic failure, cirrhosis, portal hypertension (esophageal varices) and active hepatitis
* diabetic hemorrhagic retinopathy or other hemorrhagic ophthalmic conditions
* active peptic ulceration
* arterial aneurysm and known arterial/venous malformation
* neoplasm with increased bleeding risk
* Acute pericarditis and/or subacute bacterial endocarditis
* Acute pancreatitis
* hypersensitivity to the active substance tenecteplase and to any of the excipients
* use of Abciximab (ReoPro®) or other marketed GPIIb/IIIa antagonists within the preceding 12 hours
* any minor head trauma and any other trauma occurring after onset of the current myocardial infarction
* any known history of stroke or transient ischemic attack or dementia
* pregnancy or lactation, parturition within the previous 30 days. Women of childbearing potential must have a negative pregnancy test
* any known active participation in another investigative drug study or device protocol in the past 30 days
* previous enrollment in this study
* inability to follow protocol and comply with follow-up requirements
* any other condition that the investigator feels would place the patient at increased risk if the investigational therapy is initiated
Regulatory T-cells in Psoriasis Patients as Targets for Therapy

The aim of this study is to understand which therapies will suppress effector cells and promote regulatory T cells and To test whether patients with a better response to therapy and longer psoriasis-free periods develop a higher numerical ratio of regulatory to effectors T-cells and/or regulatory cells more able to suppress the effectors.

This is an observational study for the effect of different treatment options of psorisis on regulatory T-cells. Patients in whom a decision to treat with one of the following therapies (Dovobet, neotigason, narrow-band UVB and anti TNF alpha therapy) and agreed to take part in the study will be selected. Allocation of different treatments to patients is not part of the study. We will enroll 40 patients with moderate to severe psoriasis in the age range from 18 to 70. patients must be treatment-free for at least 2 weeks for topical application and 4 weeks for systemic treatment of psoriasis. females of child bearing potential must be on reliable contraception. Children below 18 years, patients above 70 years, pregnant and lactating patients and immunosuppressed patients are excluded from this study. Blood and tissue samples will be taken before and after treatment. We will also invite 10 patients who are receiving ellipse excisions of naevi, and who known not to have psoriasis, to provide control samples of distal skin beyond the margins required to demonstrate complete removal and control donation of blood.

Eligibility Criteria:
Inclusion Criteria:

* • Male and female patients in the age range from 18 to 70 who are diagnosed with moderate to severe psoriasis.

  * Patients must be treatment free for at least 2 weeks for topical application and 4 weeks for systemic treatment of psoriasis.
  * Women of child bearing potential must be on reliable contraception.
  * Patients in whom a decision to treat with one of the following therapies has already been made based on normal clinical care:

    * Dovobet
    * Neotigason
    * Narrow-band UVB
    * Etanercept
    * Adalimumab
    * Infliximab
  * 10 normal controls

Exclusion Criteria:

* • Children below 18 years and patients over 70 years.

  * Pregnant and lactating patients.
  * Patients who are known to have immunosuppressive disease (e.g. HIV) or on any immunosuppressive therapy.
DNA Methylation and 1-C Metabolism Nutrient Intake

The present study used a sub-sample of the Melbourne Collaborative Cohort Study (MCCS) (Milne RL et al, Int J Epidemiol, 2017), who had valid data on dietary intakes (121-item food frequency questionnaire) and valid measures of DNA methylation using the HumanMethylation Infinium 450K Beadchip assay, or using LINE-1, Alu and Sat2 assays.

The investigators studied the association between nutrients involved in one-carbon metabolism and DNA methylation in peripheral blood.


Eligibility Criteria:
Inclusion Criteria:

* Selected into one of six case-control studies nested in the Melbourne Collaborative Cohort Study
* Completed a 121-item Food Frequency Questionnaire
* Had a blood DNA sample with a measure of methylation

Exclusion Criteria:

* Missing data in any of the outcome, exposure, or confounders (N=797 excluded)
Study of Chemotherapy With Adoptive Cellular Therapy With DC-CIK Cells in Triple Negative Breast Cancer Patients

To access the effectiveness of cyclophosphamide combined thiotepa and carboplatin chemotherapy combined with adoptive cellular therapy with dendritic and cytokine-induced killer cells in triple negative metastatic breast cancer patients

1. Metastatic breast cancer patients should be definitively diagnosis based on histopathology, with ER-negative and PR-negative, FISH testing for her-2-negative
2. All the patients enrolled will be given standard cyclophosphamide combined thiotepa and carboplatin chemotherapy and cellular therapy.Cellular therapy consisting of one cycle of chemotherapy followed by an apheresis and ex vivo cultures to generate DC and CIK, followed by low-dose Oral Cyclophosphamide .
3. The response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines.
4. Estimate time to progression, survival rates and clinical benefit response on patients.
5. Find biomarkers associated with drug response.

Eligibility Criteria:
Inclusion Criteria:

* Failure to anthracycline and/or taxol chemotherapy;
* metastatic tumor is histologically confirmed by immunohistochemical staining to be ER-negative and PR-negative. FISH testing for her-2-negative;
* Metastatic tumor can not be removed through surgery procedure;
* An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
* Normal cardiac, hepatic, renal and bone marrow functions;
* Life expectancy ≥3 months.

Exclusion Criteria:

* Central nervous system metastases;
* Serious or uncontrolled concurrent medical illness;
* History of other malignancies;
* Having been enrolled in some other clinal trials within a month;