cyrilzakka/clinical-trials huggingface dataset:
Unidos Contra El VPH

The purpose of the Unidos Contra el VPH study is to help find options to screen, or check, for cervical cancer that individuals can do at home to help prevent and detect cervical cancer early. Usually, people get screened for cervical cancer with a Pap smear and human papillomavirus (HPV) test by a health care provider. This is not always easy for individuals who are not able to get to a clinic or feel uncomfortable having the procedure done. That is why we want to find other ways that may be easier and more comfortable for people to be screened for cervical cancer.

The two main questions the study aims to answer are:

1. How do the following three cervical cancer screening methods compare for improving screening completion rates?

   o In-home HPV self-sampling with a vaginal swab
   * In-home HPV self-sampling with urine testing
   * In-clinic traditional Pap smear with HPV test
2. What are participant beliefs and preferences regarding these three screening methods?

   Participants in the study will be randomly assigned to one of three groups. This means each person has an equal chance of being placed in any group. They will also complete two surveys as part of the study. The three screening method groups are described below:

   Group 1: Urine Self-Sampling
   * Participants in this group will receive a kit with a urine sample cup to use at home, instructions explaining how to take the sample and a pre-paid mailing box to mail the urine sample to the lab.

   Group 2: Vaginal Swab Self-Sampling o Participants in this group will receive a kit with a vaginal swab and collection tube to use at home, instructions explaining how to take the sample and a pre-paid mailing box to mail the sample to the lab.

   Group 3: In-Clinic Screening
   * An in-clinic co-testing appointment is scheduled for a Pap smear and HPV test done together at Project Vida Health Center.

   By comparing these approaches, this study aims to improve access to cervical cancer screening and provide better options for those who face barriers to clinic-based screening.


Eligibility Criteria:
Inclusion Criteria:

* Individuals with a cervix who are 30-65 years and have not undergone a Pap test in at least three years.

Exclusion Criteria:

* Having had a hysterectomy or a personal history of cervical cancer.
A Study to Evaluate the Efficacy and Safety of IBI302 inSubjects With Diabetic Macular Edema（DME）

The study is designed for multi-center,randomized,double-masked,active-contralledstudy to evaluate effective and security of intravitrealinjection of IBI302 in subjects with Diabetic Macular Oedema.


Eligibility Criteria:
Inclusion criteria： Informed Consent Form (ICF) must be signed before participating in the study, compliance is good, and willing to complete the visit as planned; Subjects aged 18-80 years (inclusive) at the time of screening, and diagnosed with type I or type II diabetes; DME involved the macular fovea at screening; CST≥320 μm as confirmed by OCT in the study eye at screening. At baseline, visual acuity loss in the study eye due to DME with BCVA ranging from 19 to 78 ETDRS letters (inclusive); Currently use of insulin, or other injectable drugs, or oral hypoglycemic agents to treat diabetes, HbA1c ≤10% at screening;

Exclusion criteria： Eye disease High-risk PDR in the study eye; Dense hard exudation that destroyed the fovea structure of the macula in the study eye; Iris neovascularization in the study eye; Other systemic/ocular disease associated with the study eye may cause subjects fail to respond to study treatment or confuse the interpretation of study findings; Uncontrolled glaucoma in the study eye; Eye treatment Any previous treatment with IBI302 in the study eye before baseline; Intravitreal injection of anti-VEGF or anti-complement agents in the study eye within 90 days prior to baseline; Panretinal photocoagulation or macular laser (focal, grid or micropulse) in the study eye within 90 days prior to baseline; Cataract surgery was performed in the study eye within 90 days prior to baseline; YAG laser capsulotomy or YAG laser peripheral iridotomy were performed in the study eye within 90 days prior to baseline.

Any other intraocular surgery (eg, corneal transplantation, glaucoma filtration, pars plana vitrectomy, or radiotherapy) Systemic diseases/treatments Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable antidiabetic medication \<90 days prior to administration.

Uncontrolled hypertension. Systemic use of anti-VEGF or anti-complement agents within 90 days prior to baseline The presence of any other pre-existing disease, metabolic disorder, abnormal results on a physical examination or clinical laboratory examination that may reasonably be suspected of causing contraindications with the investigational drug, or affecting the interpretation of study results, or placing subjects at high risk of treatment complications (e.g., coagulation dysfunction, history of acute cardiovascular and cerebrovascular disease, history of treated or untreated malignancies within the past 5 years, etc.) Systemic treatment for suspected or active systemic infection (e.g., tuberculosis, hepatitis B, hepatitis C, etc.); Pregnant or lactating women.
Development of a NIPTT for Detecting Copy Number Variations

To collect whole blood samples from pregnant women for the purpose of developing, optimizing and evaluating laboratory-developed noninvasive prenatal test (NIPT) for the detection of fetal chromosomal abnormalities of interest defined as microinsertions, microdeletions and other copy number variations (CNVs). The NIPT result will be compared to the test results obtained by microarray analysis of fetal cellular material obtained by amniocentesis or chorionic villus sampling.

This is a single center specimen collection study. Eligible subjects from across the USA will be referred to the single center for participation.

This study will evaluate whether the test methods being developed for the detection of fetal chromosomal abnormalities of interest in maternal whole blood samples can be used in clinical practice.

Enrollment of study subjects will be done in two phases - an initial pilot study phase to collect samples for research and development activities, followed by a larger single-blinded sample collection phase for NIPT evaluation. For both phases, study subjects will be enrolled in a prospective manner until the predetermined sample size is attained. Each study subject will be asked to provide one 20mL blood sample.

Eligibility Criteria:
Inclusion Criteria:

* Subject is female
* Subject is 18 years of age or older
* Subject is pregnant at no less than 10 weeks and no more than 36 weeks gestation
* Subject provides a signed and dated informed consent
* Subject has a current pregnancy in which the fetus is determined to have a chormosomal abnormality of interest (microinsertions, microdeletions and other CNVs) as determined by microarray analysis of fetal cellular material obtained by IP

Exclusion Criteria:

* Subject has experienced fetal demise in the current pregnancy
Different Modes of Ventilation During Cardiopulmonary Bypass

66 patients divided into 3 groups with different modes of ventilation.

Sixty-six patients going through open-heart surgeries were included in the study, divided into 3 groups (P: pressure controlled ventilation, V: volume controlled ventilation, C: control) in accordance with the mode of ventilation. Patients studied for chest x-ray, lung ultrasound, arterial oxygen partial pressure to fractional inspired oxygen ratio (PaO2/FiO2), Alveolar-arterial oxygen gradient, static lung compliance and dynamic lung compliance, taken after induction of anesthesia, 1h post cardiopulmonary bypass, 1h after arrival to cardiac surgical unit.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoingvalve surgeries
* Patients undergoing coronary artery bypass grafting surgeries

Exclusion Criteria:

* Emergency cases.
* Off-pump surgeries.
* Patients with chronic lung diseases with forced expiratory volume in first second (FEV1) or forced vital capacity (FVC) less than 40% of the predicted value.
* Massive blood transfusion during surgery.
* Complicated surgeries.
* Redo surgeries.
* Patients with decompensated heart failure prior to surgery.
* Patients refusal
Single Ascending Dose of AMG 609 in Participants With Non-alcoholic Fatty Liver Disease

This study aims to assess the safety and tolerability of AMG 609 when administered subcutaneously as single doses in participants with non-alcoholic fatty liver disease (NAFLD).


Eligibility Criteria:
* Inclusion Criteria

  * Men and women age ≥ 18 to ≤ 70 years of age at the time of signing the informed consent
  * Body mass index (BMI) of ≥ 27 kg/m2 to ≤ 45.0 kg/m2
  * Liver steatosis, measured by MRI-PDFF, greater than 8%
* Exclusion Criteria

  * Evidence of other liver disease (eg, viral hepatitis, primary sclerosing cholangitis, primary biliary cholangitis, autoimmune chronic hepatitis, Wilson's disease, alpha-1 anti-trypsin deficiency, haemochromatosis, drug-induced liver injury, bile duct obstruction, known or suspected hepatocellular carcinoma).
  * Significantly elevated LFTs (more than 1.5x ULN)
  * Uncontrolled diabetes (HgbA1c \> 9%) or uncontrolled hypertension.
  * History of malignancy of any type, other than in situ cervical cancer or surgically excised non-melanomatous skin cancers occurring more than 5 years prior to randomization or 3 years prior to randomization for basal cell carcinoma.
  * Females of reproductive potential.
A Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Participants Undergoing Elective Total Knee Replacement Surgery

The primary purpose of Part 1 in this study is to assess the safety and tolerability of JNJ-64179375 for each dose level for dose escalation and any bleeding events (the composite of major, clinically relevant non-major, and minimal bleeding events) for the selection of doses for Part 2. The primary purpose of Part 2 is to assess the efficacy dose response of JNJ-64179375 for the prevention of total venous thromboembolism (VTE) (proximal and/or distal deep vein thrombosis \[DVT\] \[asymptomatic confirmed by venography assessment of the operated leg or objectively confirmed symptomatic\], nonfatal pulmonary embolism \[PE\], or any death).

This study has 2 parts, dose escalation and dose-response evaluation, and will be conducted in participants undergoing primary unilateral elective Total Knee Replacement (TKR) surgery. Participants will participate in either Part 1 or Part 2 of study only. The study will be conducted in 3 phases: an up to 30-day screening phase before surgery, a 14-day double-blind dosing phase, and a 16-week follow-up phase. Safety evaluations will include monitoring of all nonserious and serious adverse events, clinical laboratory tests, vital signs measurements, and physical examinations. Pharmacokinetics (dense and sparse), pharmacodynamic (PD), health resource utilization, and immunogenicity samples will also be assessed. The total study duration of participant's participation in Part 1 or part 2 after randomization will be approximately 18 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Weight greater than or equal to (\>=) 40 kg to less than or equal to (\<=) 150 kilogram (kg)
* Medically appropriate for postoperative anticoagulant prophylaxis as determined by the investigator
* Has undergone an elective primary unilateral total knee replacement (TKR)
* Before randomization, a woman must not be of childbearing potential defined as postmenopausal (defined as no menses for 12 months without an alternative medical cause) and/ or permanently sterile (include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy)
* Contraceptive use by men should be consistent with local regulations regarding the use of contraceptive methods for participant participating in clinical studies

Exclusion Criteria:

* Any condition for which the use of apixaban is not recommended in the opinion of the investigator
* Bilateral, revision or unicompartmental procedure
* Known or suspected hypersensitivity or intolerance to any biologic medication or known allergies or clinically significant reactions to murine, chimeric, or human proteins, monoclonal antibodies or antibody fragments, or any of the excipients of JNJ-64179375
* Unable to undergo venography
* Known previous deep vein thrombosis (DVT) in either lower extremity
Quantitative Studies of Urinary Bladder Sensation

The purpose of this study is to determine whether more than one subpopulation exists of patients with the diagnosis of Interstitial Cystitis (IC) based on sensory testing and to determine if subjects with IC have normal counterirritation-related modulatory systems.

To determine whether more than one subpopulation exists of patients with the diagnosis of Interstitial Cystitis (IC) based on sensory testing and to determine if subjects with IC have normal counterirritation-related modulatory systems. Previous studies by the PI suggest that two populations of subjects are present in the IC population but a larger number of subjects with IC would need to be tested in order to determine if this were indeed true. Other studies have demonstrated that counterirritation-related effects are absent in several chronic pain populations including fibromyalgia and chronic headaches. Identification of a subset of IC patients or the identification of a failure of counterirritation-related effects may predict responses to therapeutic interventions.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to read and speak English
* 19 years or older
* IC Diagnosis

Exclusion Criteria:

* Over 65 years old
* Pregnant
* Children younger than 19
* Significant cardiac disease
The Use of Etanercept (Enbrel®) in the Treatment of Acute Graft-Versus-Host Disease

Etanercept (Enbrel) will be added to standard therapy for acute Graft-versus-Host Disease to see if the effectiveness of standard therapy can be improved.

Partial Funding Source- FDA OOPD

The standard treatment for acute graft-versus-host disease is a combination of steroids and tacrolimus or cyclosporine. Previous work has shown that less than 50% of patients respond fully to GVHD. Without a good response, patients often have a prolonged treatment for this disease, often involving hospitalization and sometimes even death.

Etanercept is a drug that blocks a chemical called Tumor Necrosis Factor (TNF) from causing damage to tissue. Etanercept (Enbrel) will be added to help improve the response to standard treatment for graft-versus-host disease (GVHD).

This is an experimental research project. It is not known whether the etanercept will actually improve the body's response to graft-versus-host disease. This treatment is meant to determine if etanercept will improve your response to treatment of GVHD.

Eligibility Criteria:
Inclusion Criteria:

* Patient may be transplanted with stem cells from any source using either a myeloablative or nonmyeloablative preparative regimen
* Patient may be any age
* Patient must have biopsy proven new onset of aGVHD; Clinical Grading must be II-IV and may occur after stem cell transplant or donor leukocyte infusion (DLI). Patients may begin Etanercept treatment prior to biopsy confirmation of GVHD. Acute GVHD will be determined by clinical presentation and not timing from stem cell infusion
* Patient must be on solumedrol at a dose of 2mg/kg/day of actual body weight for no more than 72 hours prior to the initiation of etanercept
* Patient must have evidence of neutrophil engraftment with an ANC of \> 500 for three consecutive days
* Pulse ox \> 90% on room air

Exclusion Criteria:

* Pregnancy or nursing mother
* Intolerance or allergic reaction to etanercept
* Previous use of steroids for treatment of acute GVHD
* Active infection, chronic or localized, not responding to antibiotics, with continued signs of infection (patients with a positive C. Difficile test will not be excluded from the study)
* Condition that might predispose to developing serious infections (i.e. active and uncontrolled diabetes mellitus, sickle cell anemia)
* Other investigational agents for the treatment or prophylaxis of graft-vs-host disease within the past 2 weeks
* Serum creatinine \> 2.0mg/dl
* Patients being treated for acute pulmonary dysfunction (IPS) study using etanercept
* Patients with hypotension believed to be secondary to sepsis syndrome or heart failure requiring \> 1 inotropic agent, or dopamine \>5mcg/kg/minute for blood pressure support
* Evidence of congestive heart failure on clinical exam
* Evidence of hepatic dysfunction with an ALT or AST \> 2.5 x ULN, not due to GVHD
Study to Evaluate Whether BLI-489 Can be Safely Tolerated by Healthy Subjects Given Multiple Doses

To determine the safety, tolerability, and drug absorption profile of multiple IV doses of BLI 489 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Men or women of non-childbearing potential (WONCBP) aged 18 to 50 years inclusive at screening;
* Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight ≥50 kg.;
* Healthy as determined by the investigator on the basis of screening evaluations;
* Calculated creatinine clearance within normal limits using the Cockcroft-Gault formula;
* Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history, and if a smoker must be able to abstain from smoking during the inpatient stay;
* Have a high probability for compliance with and completion of the study.

Exclusion Criteria:

* Presence or history of any disorder that may prevent the successful completion of the study;
* Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease;
* Any surgical or medical condition that may interfere with the distribution, metabolism, or excretion of the investigational product;
* Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before study day 1;
* History of drug abuse within 1 year before study day 1;
* Admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements.
Retrospective Review a Comprehensive Case Database of HoLEP Procedure Performed by a Single Surgeon

Persistent detrusor overactivity (DO) after transurethral prostatectomy results in symptomatic failure in more than one third of the patients. Storage symptoms are major complaints in the early postoperative period after Holmium Laser Enucleation of the Prostate (HoLEP). To investigate the effect of DO in the patients with Benign Prostatic Obstruction (BPO), the investigators evaluated the changes in the storage symptoms following HoLEP in conjunction with the prescription of the anticholinergic drugs.

Eighty men with urodynamically proven BPO underwent HoLEP at our hospital. All patients were evaluated preoperatively with International Prostate Symptom Score (IPSS), International Continence Society male questionnaire short form (ICS-SF), 3-day frequency - volume charts (FVC), transrectal ultrasonography, and uroflowmetry with postvoid residual urine volume. The patients were divided into two groups; BPO without DO (Non-DO group) and BPO with DO (DO group). We assessed the patients postoperatively at 2 weeks, 1, 3 and 6 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* 50 yrs or greater
* International prostatic symptom score \>= 12
* Bladder outlet obstruction confirmed by pressure-flow study (BOOI \> 20)

Exclusion Criteria:

* Patients with urologic malignancies such as prostate cancer and bladder cancer
* Patients underwent urethral, prostate surgery
* Patients with urethral stricture or bladder diverticulum or bladder neck contracture
Duodenal Jejunal Bypass for Type 2 Diabetes (DJBD)

Study the effect of Duodenal jejunal bypass on human adults with type 2 diabetes.

Adults non obese ( BMI less than 34 ) will undergo duodenal jejunal bypass. The Outcome measures: Blood Sugar, Insulin,HbA1c, CCK,Gastrin, GIP1and 2, Ghrelin, Cholesterol, Triglycerides,FFA, C-Peptide.

Eligibility Criteria:
Inclusion Criteria:

* Adults age 20-65
* Clinical diagnosis of type 2 diabetes
* Non obese with BMI less than 34.
* Oral agents or insulin to control T2DM.
* Inadequate control of diabetes as defined as HbA1c\>/7.5
* Understanding of the mechanisms of action of the treatment

Exclusion Criteria:

* Children with type 1 diabetes
* Obese with BMI over 34
* Coagulopathy
* Liver cirrhosis
* Unable to comply with study requirements, follow-up or give valid consent
* Currently pregnant
* Previous upper abdominal surgery
* Inabilty to tolerate general anesthesia
Neurotoxicity and Cardiotoxicity in Total Joint Arthroplasty

The purpose of this research is to understand whether patients who previously had total hip or total knee replacement experience memory, thinking or heart problems. This study will help us determine if and how often these problems occur.

At your first visit you will be asked to do the following.

* Sign this informed consent document.
* Questionnaire: You will be asked to complete a questionnaire about your family history of neurological diseases and current and past physical thinking activities.
* Interview: The interview will be performed by the study coordinator who is a member of the research team. It will take about 20-30 minutes to complete. You will be asked to answer questions about your general health, surgeries, medications, and your memory and thinking skills.
* Memory Interview: You will have an evaluation of your memory and thinking skills. You will answer questions and perform tasks that evaluate various thinking abilities such as concentration, memory, reasoning, and learning.
* Blood draw: Have a sample of blood drawn (4.2-5 tablespoons) for clinical and research tests.
* Magnetic Resonance Imaging (MRI) of your brain (optional): If you agree to participate, you will be asked to have MR imaging of your brain.
* Echocardiogram: You will be asked to have an echocardiogram of your heart.
* Follow-up visit in 2-3 years: You will be asked to return to Mayo for your second study visit in 2-3 years. At this visit, you will be asked to complete the same memory and thinking tests described for the first visit. You will also be asked to repeat the echocardiogram.

Eligibility Criteria:
Inclusion Criteria:

* Patient is willing to sign consent
* Patients scheduled for revision surgery for osteolysis, aseptic loosening, or wear of TJA implants/ALTR.

OR

-MCSA (Mayo Clinic Study of Aging) patients with THA or TKA with at least 10 years since surgery.

Exclusion Criteria:

* History of dementia
* History of cardiomyopathy or heart failure
* Revision for infection or fracture
* Patient is pregnant
* Patient has medication patches on
* Patient has a pacemaker or defibrillator (ICD)
* Patient has a deep brain stimulator (DBS)
* Patient has a vagal neuro stimulator (VNS)
* Patient has any other kind of neuro stimulator
* Patient has aneurysm clips in their head
* Patient has a tissue expander
* Patient has had a gastrointestinal clip or pill camera inserted in the last 90 days
* Patient has an esophageal reflux management system (LINX)
* Patient has a cochlear (ear) or auditory implant
* Patient has any implanted device (electronic or not) with magnets
* Patient has an eye injury involving metal
* Patient has allergy to contrast or dye