cyrilzakka/clinical-trials huggingface dataset:
A CLinical Study to Evaluate the Safety And Effectiveness of the CeRene DevIce to Treat HeavY Menstrual Bleeding

The purpose of the study is to evaluate the safety and effectiveness of the Cerene Cryotherapy Device in reducing menstrual bleeding in women with heavy menstrual bleeding (menorrhagia) due to benign causes for whom child bearing is complete.


Eligibility Criteria:
Inclusion Criteria:

* Refractory heavy menstrual bleeding with no definable organic cause
* Female subject age 25 to 50 years, inclusive
* Sounded length of uterine cavity no greater than 10 cm and endometrial cavity no greater than 6.5 cm
* Sufficient myometrial thickness
* Documented excessive menstrual blood loss within 3 months of informed consent
* Premenopausal confirmed by follicle stimulating hormone (FSH) measurement
* Agrees to use a reliable form of contraception following ablation treatment
* Provides written informed consent using a form that has been approved by the reviewing ethics committee
* Agrees to follow-up exams and data collection requirements
* Demonstrates an understanding of how to record menstrual blood loss using a menstrual pictogram
* Has predictable, cyclic menstrual cycles

Exclusion Criteria:

* Pregnant or has a desire to conceive
* Endometrial hyperplasia as confirmed by histology
* Active endometritis
* Active pelvic inflammatory disease
* Active sexually transmitted disease (STD)
* Presence of bacteremia, sepsis, or other active systemic infection
* Active infection of the genitals, vagina, cervix, or uterus
* Known/suspected abdominal, pelvic, or gynecological malignancy within the past 5 years
* Known clotting defects or bleeding disorders
* Abnormal cytology on Human papillomavirus (HPV) testing not treated according to local standards.
* Prior uterine surgery that interrupts the integrity of the uterine wall (e.g., transmural myomectomy or classical cesarean section).
* Previous low transverse cesarean section where the myometrial wall thickness is insufficient
* Previous endometrial ablation procedure
* Clinically significant adenomyosis indicated by subject complaints, imaging, or clinician's judgment
* Presence of an implantable contraceptive device
* Currently on medications that could thin the myometrial muscle
* Currently on anticoagulants
* Abnormal or obstructed cavity
* Currently using an intrauterine device (IUD) and unwilling to remove the IUD
* Post-partum ≤ 6-months
* Considering participation in a research study of an investigational drug or device that would begin during the course of this investigational study
* Any general health or mental, or other situation or condition which, in the opinion of the Investigator, could represent an increased risk for the subject or impact the subject's ability to comply with protocol requirements
Interest of Rapid Typing in Adenovirus Infections.

Proposal of a "rapid typing" technique by a new real-time PCR method, simpler, faster and cheaper than nucleotide sequencing (reference method) for rapid typing in Adenovirus infections.

Adenoviruses cause many infections, mainly respiratory and gastroenteric, in pediatrics.

They also behave as opportunistic agents in 10% of hematopoietic stem cell recipients. In these immunocompromised persons, these infections are all the more frequent as the graft is of placental origin and the recipient a child (20%). They are then willingly disseminated and potentially deadly; their treatment is based on cidofovir, a viral agent that is very sensitive to handling.

Adenoviruses, which have a high genetic diversity, are classified into 7 types. According to some observations, still limited, some types of Adenovirus would show a higher pathogenicity (types C and A). Thus, viral typing may be prognostic for immunocompromised patients, justifying the initiation of an earlier specific treatment when identifying certain more pathogenic viral types, in addition to measuring the viral load, already performed by quantitative PCR.

For this purpose, this study proposes a "fast typing" technique by new real-time PCR method, simpler, faster and cheaper than nucleotide sequencing, reference method.

Eligibility Criteria:
Inclusion criteria:

- viral load greater than or equal to 10 \^ 4 copies / mL (blood and body fluids) or copies / gram of stool or copies / μg of DNA (biopsies).

Exclusion Criteria:

* Samples identified as positive in Adenovirus, not re-analyzable (insufficient sample quantity, alteration during thawing).
Randomized, Double-Blind, Placebo-Controlled, Crossover Study of Trans Sodium Crocetinate in Healthy Volunteers Exercising at Altitude

This is a randomized, placebo-controlled, crossover study of Trans Sodium Crocetinate (TSC) in healthy volunteers, age 18-40 (inclusive), exercising at altitude. The primary objective is to determine the effect of (TSC) on partial pressure of oxygen (PaO2) and maximal oxygen consumption (VO2 max); the secondary objective is to assess the effect of TSC on oxygen saturation (SpO2).


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males and females ages 18-40
2. Non-smoking
3. Able to provide informed consent and agree to adhere to all study visits and requirements.
4. Females of childbearing potential must have a negative blood pregnancy test at screening and agree to use one of the accepted contraceptive regimens, or a double method of birth control during the study and at least 30 days after the last dose of study drug.
5. Males who engage in sexual activity that has the risk of pregnancy must agree to use a double barrier method and agree not to donate sperm during the study and for at least 90 days after the last dose of study drug

Exclusion Criteria:

1. Allergy to study medication
2. Pregnant or breast feeding
3. Received investigational medicine (IMP) within past 30 days
4. VO2 max \< 35 mL/kg/min (male), \< 30 mL/kg/min (female) at screening
5. Abnormal pulmonary function testing at screening
6. Surgery or hospitalization in past 3 months determined by the PI to be clinically relevant
7. History of ongoing alcohol or substance abuse
8. Known cardiovascular disease, including treated or untreated hypertension
9. Respiratory disease and/or any other significant medical condition, including psychiatric disorders
10. Clinically significant abnormality on ECG per PI discretion
11. Blood donation (excluding plasma donation) of approximately 500 mL within 56 days prior to screening
12. Plasma donation within 7 days prior to screening
13. Treatment with an investigational drug within 30 days or 5 times the half-life (whichever is longer) prior to screening
14. History of smoking
15. Urine screen positive for drugs or positive breathalyzer for alcohol (at screening and Treatment Visit Day 1)
16. History of seizures
17. Previous pneumothorax or pneumomediastinum
18. Hypo/Hyperglycemia
19. Diabetes
20. Regularly taking medications which may alter heart rate, blood pressure or cardiac output
21. Previous history of middle ear equalization problems at discretion of PI
Safety and Efficacy of XJ-Procedure in Patients With Acute Type A Aortic Dissection Surgery

This is a national, multicenter, open-label, randomized, controlled, endpoint-blinded clinical trial of patients diagnosed with ATAAD and undergoing "Sun's procedure" coordinated by the First Affiliated Hospital of Xi'an Jiaotong University, China. Per the protocol, "Sun's procedure" combined with "XJ-Procedure" in the anastomosis of the aortic root and Sun's procedure combined with regular suturing methods of the aortic root will be compared.

In this study, the investigators will prospectively enroll patients diagnosed with ATAAD and undergo "Sun's procedure" from November 2024 to November 2027 in several centers, including the First Affiliated Hospital of Xi'an Jiaotong University, and will randomly divide them into XJ-procedure group and control group. "The patients in the XJ-procedure group will undergo "Sun's procedure", in which the anastomosis of the aortic root will be performed with the XJ-procedure. The patients in the control group will also undergo "Sun's procedure", in which the anastomosis of the aortic root will be performed with each center. The primary outcome event is all-cause mortality within 12 months after surgery. Secondary outcome events are (1) incidence of residual aortic root entrapment (during hospitalization, follow-up 3 months, 6 months, 12 months) (2) rate of secondary surgery for hemostasis due to root hemorrhage (during hospitalization) (3) incidence of anastomotic pseudoaneurysm (during hospitalization, follow-up 3 months, 6 months, 12 months) (4) rate of severe regurgitation of residual aortic valves (during hospitalization, follow-up 3 months, 6 months, 12 months) (5) Incidence of major adverse cardiovascular and cerebrovascular events (MACCE) (during hospitalization, follow-up 3 months, 6 months, 12 months).

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years;
* Patients with ATAAD attending the relevant department who have been assessed by a clinician as needing "Sun's procedure".

Exclusion Criteria:

* Severe aortic root involvement (root diameter \>45 mm, root tear, severe destruction of the aortic root, combined valve disease);
* Combined coronary artery disease requiring concomitant coronary revascularization;
* Prior aortic or cardiac surgery;
* Preoperative severe malperfusion syndromes such as: severe cerebral complications (acute cerebral infarction, cerebral hemorrhage, coma, etc.); malperfusion of abdominal organs or lower extremities \>12 h;
* Preoperative combination of severe single or multiple organ failure;
* Pregnant women;
* Refused to sign the informed consent form and refused to participate in this study.
Lifestyle Modification for Type 2 Diabetes Involving Reduction of After-meal Blood Glucose Elevations

The purpose of this study is to determine if a lifestyle modification program (GEM) that focuses on reducing after-meal blood glucose elevations can improve blood glucose control in people with type 2 diabetes. Half of the participants will continue their routine medical care, and half will receive five sessions of GEM in addition to their routine care. The two groups will be assessed using diabetes-relevant medical, behavioral and psychological measures.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with type 2 diabetes within the past 5 years
* Age \>24 and \<80 years
* HbA1c \>7.0%
* Approval of primary care physician to participate

Exclusion Criteria:

* Currently using, or used within the last 3 months, medications that directly lower BG (e.g., insulin, sulfonylureas, glinides, or DPP-4 inhibitors).
* Currently using, or used within the last 3 months, thiazides at doses above HCTZ 25 mg or equivalent, or loop diuretics above furosemide 20mg or equivalent.
* Currently pregnant or contemplating pregnancy in the coming year
* Currently using, or used within the last 3 months, medications that impede weight loss (e.g., prednisone)
* Having conditions that preclude increasing physical activity, e.g. severe neuropathy, active cardiovascular disease, emphysema, osteoarthritis, stroke.
* Undergoing cancer treatment
* History of lactic acidosis
* Diagnosed with renal impairment
A Study of GDC-0853 in Patients With Resistant B-Cell Lymphoma or Chronic Lymphocytic Leukemia.

This open-label, Phase I study will evaluate the safety, tolerability, and pharmacokinetics of increasing doses of GDC-0853 in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia. In a dose-expansion part, GDC-0853 will be assessed in subsets of patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years
* ECOG score of 0-1
* One of the following histologically-documented hematologic malignancies for which no effective standard therapy exists: indolent non Hodgkin's lymphoma (NHL), follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), or chronic lymphocytic leukemia (CLL)
* At least one site of disease that, as seen on CT scan, is \> 1.5 cm in the greatest transverse diameter or \> 1.0 cm in short axis diameter (except for patients with CLL)
* An available tumor specimen
* Adequate hematologic and organ function
* For female patients of childbearing potential and male patients with partners of childbearing potential, use of effective contraceptive(s) as defined by protocol for the duration of the study

Exclusion Criteria:

* Life expectancy \< 12 weeks
* \< 3 weeks since the last anti-tumor therapy, including chemotherapy, biologic, experimental, hormonal or radiotherapy (with the exception of leuprolide or similar medications for prostate cancer)
* Recent major surgical procedure or traumatic injury, or unhealed incisions or wounds
* Active infection requiring IV antibiotics
* Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis.
* Primary CNS malignancy or untreated/active CNS metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control)
* History of other malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin cancer, Stage I uterine cancer, or other cancers with a similar outcome
* Cardiovascular dysfunction, including ventricular dysrhythmias or risk factors for ventricular dysrhythmias
* Pregnancy, or lactation
* Any other diseases that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications
EGD vs EUS in Diagnosing Portal Hypertension in Cirrhotic Patients.

Liver cirrhosis with the further development of portal hypertension implies structural and vasculature alteration in the portosplenic circulation.

Esophagogastroduodenoscopy is the standard of care for the detection and treatment of esophageal varices, as esophageal varices serve as a surrogate for estimating a portal pressure gradient \> 10 mmHG.

Endoscopic ultrasound evaluation allows the detection of peri-esophageal collateral veins, perforating veins and para-esophageal collateral veins, which has demonstrated to be effective for the prediction of esophageal varices recurrence after variceal eradication.

The investigators aimed to compare esophagogastroduodenoscopy versus endoscopic ultrasound evaluation for the early diagnosis of portal hypertension in cirrhotic patients.

A randomized control trial of 70 cirrhotic patients randomly submitted for esophagogastroduodenoscopy (35 patients) or EUS evaluation (35 patients) for the diagnosis of portal hypertension.

The portal pressure gradient will be defined based on portal vein catheterization via interventional radiology.

Esophagogastroduodenoscopy will evaluate the presence and grade of esophageal varices, presence and type of gastric varices, presence and signs of hypertensive gastropathy.

Endoscopic ultrasound will evaluate the presence of esophageal varices, the presence of gastric varices and the EUS- signs og hypertensive gastropathy, Azygos vein diameter, mean velocity and blood flow volume index.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years old
* Willingness to participate in the study
* Compensated liver cirrhosis based on clinical and imaging findings
* Written informed consent provided

Exclusion Criteria:

* Decompensated liver cirrhosis: ascitis, encephalopathy, gastrointestinal bleeding, infection
* Hemodynamic instability
* Pregant or nursing patients
* Patients with history of esophageal, gastric, liver, pancreas and spleen tumors
* Severe uncontrolled coagulopathy
* Any contraindication for portal pressure gradient meassurement via radiological evaluation.
Peptide-pulsed vs. RNA-transfected Dendritic Cell Vaccines in Melanoma Patients

Dendritic cells (DCs)are the most potent antigen-presenting cells of the immune system, as such they are able to direct the immune system specifically against cancer cells. Currently DCs are used in clinical vaccination studies and immunological and clinical responses have been observed. For inducing anti-tumor immunity, the DCs have to be loaded with tumor antigen (i.e. molecular structures that are presented by the tumor, that are recognized by the immune system). Currently most studies use tumor peptides (small protein fragments) for this purpose. This approach has several disadvantages: only patients with a certain HLA-type can be treated and the immune response that is induced by the vaccine is limited to the used peptides. These disadvantages do not exist when the DCs present antigen which is endogenously processed, for example after RNA transfection. For this reason we investigate the immunogenicity of DCs that are pulsed with peptides or transfected with mRNA encoding melanoma associated antigens in stage III and IV melanoma patients.


Eligibility Criteria:
Inclusion Criteria:

For both stage III and IV

* Histological proof of cutaneous melanoma
* Melanoma expressing both gp100 and tyrosinase, each in approximately 20% or more of cells by immunohistochemistry staining,
* HLA type A2 and/or A3, with known HLA-DR4 expression,
* WBC \> 3.0 x 109/l, lymphocytes \> 0.8 x 109/l, platelets \> 100 x 109/l, serum creatinine \< 150 μmol/l, serum bilirubin \< 25 μmol/l.
* Expected adequacy of follow-up,
* Written informed consent.

For Stage III only

* Stage III melanoma according to the 2001 AJCC criteria.
* Start of treatment within 2 months of lymph node dissection for melanoma stage III

For stage IV only

-Stage IV melanoma according to the 2001 AJCC criteria. Limited tumor burden; LDH \< 2x upper limit of normal

Exclusion Criteria:

For both stage III and IV

* No autoimmune disorders, no concomitant use of immunosuppressive drugs,
* no serious concomitant disease, no serious active infections, no other malignancy in the past 5 years with the exception of curatively treated carcinoma in-situ of the cervix/squamous cell carcinoma of the skin,
* No known allergy to shell fish (contains KLH) are excluded.
* No pregnancy or lactation,

For stage III only:

* No signs or symptoms of distant metastases as defined by normal history, physical examination, chest X-ray and serum LDH.
* No concomitant or previous systemic treatment for melanoma

For stage IV only:

* No clinical signs of CNS metastases, in patients with a clinical suspicion of CNS metastases, a CT scan of the brain should be performed to exclude this.
* No prior chemotherapy, immunotherapy, or radiotherapy within three months before planned vaccination is allowed.
Exploratory Study of the Safety, Tolerability and Efficacy of Multiple Regimens of Natalizumab in Adult Participants With Relapsing Multiple Sclerosis (MS)

The primary objective of this study is to explore the effects of multiple regimens of natalizumab on disease activity and safety in participants with relapsing-remitting Multiple Sclerosis (RRMS).

This is a a dose and frequency (but not route of administration) blinded, prospective, randomized, dose-ranging study in patients with RRMS who have received natalizumab for at least 12 months according to the local prescribing guidelines. The study will explore dosing of natalizumab by subcutaneous and intravenous routes. Participants will be randomly assigned to 1 of 6 dosing regimens, blinded to natalizumab dose, but not route, for 60 weeks of treatment.

Eligibility Criteria:
Key Inclusion Criteria:

* Ability to provide written informed consent
* Subjects of childbearing potential must practice effective contraception during the study
* A documented diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS)
* Free of MS relapse for 12 months prior to randomization
* Treatment with natalizumab for a minimum of 12 months immediately prior to randomization.
* In the 12 months prior to commencing natalizumab, subject must have experienced a minimal level of disease activity as defined by 2 or more documented clinical relapses OR 1 relapse and documented MRI activity, defined by the presence of at least 1 Gd enhancing lesion on MRI, unrelated to the relapse.

Key Exclusion Criteria:

* Known history of Human Immunodeficiency Virus (HIV), hepatitis C and/or hepatitis B virus
* Positive for anti-natalizumab antibodies at screening
* MRI positive for Gd-enhancing lesions at study entry
* Subjects for whom MRI is contraindicated
* History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic (including diabetes), urologic, pulmonary, neurologic (except for RRMS), dermatologic, psychiatric, renal, or other major disease
* History of malignant disease, including solid tumors and hematologic malignancies (with the exception of cured basal cell and squamous cell carcinomas of the skin)
* History of transplantation or any anti-rejection therapy
* History of severe allergic or anaphylactic reactions or known hypersensitivity to any drug
* A clinically significant infectious illness within 30 days prior to screening or progressive multifocal leukoencephalopathy (PML) or other opportunistic infections at any time
* Signs or symptoms suggestive of any serious infection, based on medical history, physical examination or laboratory testing

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
MR-US Image Fusion Targeted Biopsy for Single-cell Prostate Cancer Research

The investigators hypothesize that this single-cell analysis can be used to evaluate prostate needle-core biopsies prospectively even in non-homogenous samples by providing profiles of proteomic and phenotypic signatures. These profiles will in turn enable better predictions of the malignant progression of prostate cancers in the settings of current clinical practice.

Current approaches for early detection and diagnosis include prostate-specific antigen (PSA) which is a useful, though not specific, biomarker for detecting prostate cancer. The suspected patients will be further sent for digital rectal examination(DRE), in which a doctor inserts a lubricated, gloved finger into the patient's rectum to feel for lumps, enlargements, or areas of hardness that might indicate prostate cancer. However, the only test that can fully confirm the diagnosis of prostate cancer is a biopsy - the removal of small pieces of the prostate for microscopic examination. If cancer is suspected using PSA test and DRE, more than 90% suspected patients choose undergo prostate biopsy. Prostate needle biopsies are routinely done on an outpatient basis and rarely require hospitalization. Markedly, the fine needle biopsy is minimally invasive and has currently been suggested for longitudinal monitoring of highly suspected patients or follow-up therapeutic responses. The large availability of biopsy samples for prostate cancer provides a cornerstone for the proposed patient specimen-based research. The investigators anticipate that comprehensive analysis rather than simple pathological examination of these samples will generate new insights to prostate tumor progression in human.

Eligibility Criteria:
Inclusion Criteria:

* Only subjects that have scheduled Artemis prostate biopsy with defined regions of interest will be included in this study

Exclusion Criteria:

* Any subjects that are unable to provide informed consent will be excluded