cyrilzakka/clinical-trials huggingface dataset:
A Study to Learn About the Study Medicine (Nirmatrelvir Plus Ritonavir) in Pregnant Women With COVID-19

The purpose of this clinical trial is to learn about how study medicine (Paxlovid, which contains nirmatrelvir and ritonavir) is changed and eliminated from the body, as well as its safety, and the extent to which side effects can be tolerated for treatment of pregnant women with mild or moderate COVID-19 compared to non-pregnant women with mild or moderate COVID-19.

This study is seeking participants who:

* are expecting a healthy baby and are in their second or third trimester pregnancy and have mild or moderate COVID-19
* are not pregnant and have mild or moderate COVID-19.

All participants in this study will take Paxlovid by mouth every 12 hours for 5 days. We will study the experiences of people receiving the study medicine. This will help us decide if the study medicine is safe.

All participants will take part in this study for at least 34 days; pregnant participants will take part until their delivery, so that the study duration may be up to 6 months, depending on their delivery date.

During this time, participants will have 7to 8 visits and, if pregnant, a visit at delivery. Around 2 to 3 visits and the delivery visit will be done in person (at the clinic or at the participant's home). The other 5 visits may be done over the phone, unless in-person visit is necessary as decided by the doctor. Blood samples will be collected on the first 4 to 5 study visits (and at other study visits, if necessary).


Eligibility Criteria:
Inclusion Criteria:

* All cohorts: Mild-to-moderate COVID-19 infection confirmed in sample collected ≤5 days prior to enrollment; onset within 5 days prior to enrollment and presence of ≥1 sign/symptom on the day of enrollment.
* Cohorts 1\&2: Expecting single baby; Pregnant in 2nd trimester, 14 0/7 to 27 6/7 weeks of gestational age (Cohort 1) or 3rd trimester, ≥28 0/7 and ≤34 6/7 weeks of gestational age (Cohort 2), by ultrasound.
* All cohorts: Otherwise healthy participants who are determined by medical history, physical examination, and clinical judgment to be appropriate for inclusion in the study

Exclusion Criteria:

* All cohorts: Current need for hospitalization or anticipated need for hospitalization in the clinical opinion of the site investigator.
* Cohorts 1\&2: Prior/current major condition or illness of mother/fetus substantially increasing risk of study participation/completion or impacting pregnancy/fetal outcomes in investigator's judgement.
* All cohorts: Current use of any medications that are highly dependent on CYP3A4 for clearance, and which are contraindicated in combination with nirmatrelvir/ritonavir.
* All cohorts: Has received or is expected to receive monoclonal antibody treatment, convalescent COVID-19 plasma, or anti-viral treatment (eg, molnupiravir) for the current SARSCoV-2 infection.
* All cohorts: Participants with moderate to severe kidney impairment
Development of Quality Indicators and Quality Improvement Plan of Colonoscopy in Experienced Endoscopist

The purpose of this study is to determine clinical factors affecting quality indicators of colonoscopy including adenoma detection rate, and whether quality of colonoscopy could be elevated by improving related factors.

This study is an extension of quality assurance program in Seoul National University Hospital Healthcare System Gangnam Center. This study is composed of five periods. First, quality indicators of colonoscopy in experienced endoscopists will be analyzed retrospectively from January 2011 to december 2014. Individual differences and changes of quality indicators in every endoscopist will be verified. In second period, from January 2015 to March 2015, quality assurance program will be activated. Endoscopists will be educated by EQUIP (Endoscopic Quality Improvement Program). Also split-regimen bowel preparation instead of same-day regimen and Boston bowel preparation scale will be introduced to standardize disparity of grading. Third, prospective trial starts from April 2015 to March 2018. All endoscopists will receive feedbacks of their own adenoma detection rates in every 3 months. Changes of quality indicators for each endoscopist will be investigated, and annually monitored by institutional review board. If there is a significant improvement of quality indicators in interim assessment, prospective trial will be extended until April 2018. Fourth is wash-out period from April 2018 to march 2019. Feedbacks will be stopped and adenoma detection rates and quality indicators of endoscopists will be compared with those from prospective period. Finally, cumulative rate and mortality rate of colorectal cancers will be investigated until December 2019.

Eligibility Criteria:
Inclusion Criteria:

* Customers who received colonoscopy in Seoul National University Hospital Healthcare System Gangnam Center from 2011 to 2019.

Exclusion Criteria:

* Age \<18 years
* Customers who refused to offer their health check up data
* History of inflammatory bowel disease
* History of familial adenomatous polyposis
* Customers who received Incomplete colonoscopy
* History of previous colorectal resection
Registry of Patients With Acute/Subacute Type B Aortic Dissection Treated by Means of the STABILISE Technique (STABILISE)

The aim of the study is to evaluate results of patients treated with the STABILISE technique for acute/subacute aortic dissection. Results and postoperative events are reported in accordance with the current reporting standards for endovascular aortic repair prepared and revised by the Ad Hoc Committee for Standardized Reporting Practices in Vascular Surgery of The Society for Vascular Surgery/American Association for Vascular Surgery


Eligibility Criteria:
Inclusion Criteria:

* Patients with ≥ 18 years of age;
* Patients presenting with an acute (up to two weeks from the onset) and subacute (between 3 and 12 weeks from the onset) type B dissection with a proximal suitable non-dissected landing zone in the aortic arch or descending thoracic aorta (supra-aortic trunks debranching may be employed to obtain an adequate proximal landing zone);
* Total aortic diameter of the abdominal aorta (from supra-celiac to infra-renal level) must not exceed 42 mm;
* Patients able to sign specific informed consent for the study.

Exclusion Criteria:

* Patients with chronic type B aortic dissection (more than 12 weeks from the onset);
* Patients with acute type B aortic dissection not treated according to the following treatment protocol;
* Unwilling or unable to comply with the follow-up schedule;
* Inability or refusal to give informed consent;
* Simultaneously participating in another investigative device or drug study;
* Frank rupture;
* Systemic infection (eg, sepsis);
* Allergy to stainless steel, polyester, solder (tin, silver), polypropylene, nitinol, or gold;
* Untreatable reaction to contrast, which, in the opinion of the investigator, cannot be adequately premedicated;
* Surgical or endovascular AAA repair within 30 days before or after dissection repair;
* Previous placement of a thoracic endovascular graft;
* Prior open repair involving the descending thoracic aorta, including the supra-renal aorta and/or arch;
* Interventional and/or open surgical procedures (unrelated to dissection) within 30 days before or after dissection repair.
Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment

This PMPF study is proposed to evaluate in real life the reoperation rates (ROR) of breast cancer and/or DCIS surgery when including the use of the HLS in the context of breast lumpectomy margin assessment.


Eligibility Criteria:
Inclusion Criteria:

* Adult female Subject ≥18 years old.
* Subject Scheduled for breast conserving surgery of invasive and/or in-situ ductal carcinoma.
* Subject is able to read, understand and sign the informed consent.

Exclusion Criteria:

* Subject previously treated for ipsilateral breast cancer and/or ductal carcinoma in situ surgery.
* Subject with previous radiotherapy of the ipsilateral breast.
* Subject with multicentric/multilateral breast cancer.
* Subject with planned mastectomy, tumor-adapted breast reduction.
* Subject with pre-surgical/ preoperative neo-adjuvant treatment.
* Subject is pregnant/ lactating.
* Participation in any other clinical study that would affect data acquisition.
Yoga Intervention for Substance Use and ART Adherence in Community Reentry

People with HIV and a substance use disorder who are reentering the community from prison or jail face the dual risks of relapse and interruptions in adherence to antiretroviral therapy (ART) medication. This mixed-methods randomized controlled trial will compare the stress, substance use and ART adherence outcomes of participants in a 12-session, 90-minute weekly yoga group intervention with participants in a treatment as usual control group. All participants are re-entering the community, have HIV and experience substance use challenges.


Eligibility Criteria:
Inclusion Criteria:

* have HIV
* experience substance use challenges, within one year of reentry from prison or jail
Topical Cyclosporine and Disease Progression

The purpose of this study is to evaluate the effect Restasis has in regards to disease progression.


Eligibility Criteria:
Inclusion Criteria:

* Mild to Moderate dry eye symptoms

Exclusion Criteria:

* Current use of Restasis
Study of Retinfanlimab in Combination With INCAGN02385 and INCAGN02390 as First-Line Treatment in Participants With PD-L1-Positive (CPS ≥ 1) Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck

The purpose of this study is to evaluate the safety and efficacy of the combination of retifanlimab plus INCAGN02385 and retifanlimab plus INCAGN02385 and INCAGN02390 compared with retifanlimab alone as first-line treatment in PD-L1-positive and systemic therapy-naive recurrent/metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN).


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed R/M SCCHN that is not amenable to therapy with curative intent. Participants who refuse potentially curative salvage surgery for recurrent disease are ineligible.
* Eligible primary tumor locations are oropharynx, oral cavity, hypopharynx, and larynx.
* Participants must not have received prior systemic therapy for R/M SCCHN.
* PD-L1 positive tumor status defined by CPS ≥ 1% per central laboratory determination.
* For participants with primary oropharyngeal tumors, documentation of HPV p16 status based on local institutional standard is required. HPV p16 status is not required for other eligible SCCHN primary tumor sites.
* Participant must have at least 1 measurable tumor lesion per RECIST v1.1.
* Availability of archival tissue for biomarker analysis from a core or excisional biopsy or willingness to undergo a fresh biopsy.
* ECOG performance status of 0 or 1.
* Willingness to avoid pregnancy or fathering children.

Exclusion Criteria:

* Progressive or recurrent disease within 6 months of the last dose of systemic treatment for locally advanced SCCHN. Prior PD-(L)1, LAG-3, or TIM-3 directed therapy, or any other checkpoint inhibitor therapy, for SCCHN or any other malignancy.
* Treatment with anticancer therapies or participation in another interventional clinical study within 21 days before the first administration of study treatment.
* Presence of tumors that invade major blood vessels, as shown unequivocally by imaging, and with active bleeding.
* Participants with primary tumors of the nasopharynx, sinonasal cavity, or salivary and are excluded.
* Less than 3-month life expectancy.
* Participant has not recovered to ≤ Grade 1 or baseline from residual toxicities of prior therapy.
* Participant has not recovered adequately from toxicities and/or complications from surgical intervention before starting study treatment.
* Palliative radiation therapy administered within 1 week before the first dose of study treatment or radiation therapy in the thoracic region that is \> 30 Gy within 6 months before the first dose of study treatment.
* Known active CNS metastases and/or carcinomatous meningitis. Participants will be excluded if it has been \< 4 weeks since radiation therapy was delivered to the CNS.
Comparison Between Anterior Segment Optical Coherence Tomography and Ultrasound Bio Microscopy Parameters in Glaucoma Assessment

Study aiming to compare between anterior segment Optical Coherence Tomography and Ultrasound BioMicroscopy In Glaucoma aSSESMENT

Glaucoma is comprised of a group of optic neuropathies that share certain biological and clinical characteristics including progressive loss of the RGCs that causes specific, irreversible changes to the optic disc and visual field Visualization of the anterior chamber (AC) angle is a critical step in the diagnosis of glaucoma, especially angle-closure variants. .

UBM has been used in imaging and quantitative evaluation of anterior ocular segments since the 1990s. It allows in vivo observation of the anatomy and pathology of the anterior segments, from the conjunctiva and cornea to the iris and basal vitreous body, which provides significant information on glaucoma, cysts, neoplasms, trauma and foreign bodies. UBM also provides biometric information of anterior segment structures, such as anterior chamber (AC) depth, anterior chamber angle (ACA), and iris thickness. UBM provides more detailed information compared to slit-lamp, gonioscopy or B-scan examinations for diagnosis and follow-up of PAC eyes.In some cases UBM elucidates the mechanism of elevated intraocular pressure by showing the relationship between the peripheral iris and the trabecular meshwork. It can be used to study the causes of secondary glaucoma, for example, the pigment dispersion syndrome, lens-induced glaucoma, ciliary block, cysts, and solid tumors of the anterior segment. It can also assess the effects of various interventions such as laser iridotomy, trabeculectomy, and non-penetrating drainage surgery. Precise quantitative evaluation of the anterior chamber angle structures can help in diagnosis and management of various pathologies related to glaucoma . Optical coherence tomography (OCT) is a widely used non-invasive fundus imaging technique. Since the first application of OCT in the cornea in 2002\], anterior segment-optical coherence tomography (AS-OCT) has developed rapidly. There are two major OCT platforms on the market: time domain-optical coherence tomography (TD-OCT) and spectral (or Fourier) domain-optical coherence tomography (SD/FD-OCT) . With a higher imaging resolution than UBM, AS-OCT makes it easier for the operator and software to identify ACA structures. such as: the scleral spur (SS), iris surface, Schwalbe's line, even trabecular meshwork (TM), and Schlemm's canal. This provides more precise analysis of the angle opening distance (AOD) from the SS, ACA, trabecular iris angle (TIA), and trabecular iris space area (TISA)

Eligibility Criteria:
Inclusion Criteria:

* Patients with open and angle closure glaucoma. Male and female patients were included. Patient age: more than18 years old

Exclusion Criteria:

Previous glaucoma surgery. Previous cataract surgery. Media opacity. Associated ocular or intra ocular inflammation. Associated corneal pathology.
Primary Antibiotic Prophylaxis Using Co-trimoxazole to Prevent Spontaneous Bacterial Peritonitis in Cirrhosis

A multicentre, interventional, double-blind, placebo-controlled, parallel-arm, phase 3, randomised controlled trial to evaluate the use of co-trimoxazole as primary prophylaxis for spontaneous bacterial peritonitis to improve overall survival

See above

Eligibility Criteria:
Inclusion criteria:

1. Patients with Child-Pugh Class B or C cirrhosis and presence of ascites requiring any diuretic treatment or at least 1 or more paracentesis within 3 months prior to enrolment.
2. Patient at least 18 years of age
3. Documented informed consent to participate

Exclusion criteria:

1. Patients with current or previous Spontaneous Bacterial Peritonitis (defined as ascitic polymorphonuclear (PMN) cell count \>250/mm3 with either positive or negative ascitic fluid culture without evident intra-abdominal surgically treatable source of infection. A white cell count \>500 cell/mm2 or positive microbial culture may be considered as evidence of previous SBP if the site PI considers this was in the context of a likely clinical diagnosis of SBP).
2. Patients receiving palliative care with an expected life expectancy of \<8 weeks
3. Allergic to co-trimoxazole, trimethoprim or sulphonamides
4. Pregnant or lactating mothers
5. Patient enrolled in a clinical trial of investigational medicinal products (IMPs) that would impact on their participation in the study
6. Patients with serum potassium (\>5.5 mmol/L) related to pre-existing kidney disease which cannot be reduced\*
7. Patients receiving antibiotic prophylaxis (except for rifaximin)\*
8. Patients with long-term ascites drains\*
9. Women of child-bearing potential and males with a partner of child-bearing potential without effective contraception for the duration of trial treatment
10. Patients with pathological blood count changes

    1. Patients with haemoglobin (Hb) \<70g/L\*
    2. Granulocytopenia defined as absolute neutrophil counts of less than 500 cells per microliter\*
    3. Severe thrombocytopenia with a platelet count \<30 x109 /L\*
11. Patients with severe renal impairment, with eGFR \<15 ml/min\*
12. Patients with skin conditions: exudative erythema multiform, Stevens-Johnson syndrome, toxic epidermal necrolysis and drug eruption with eosinophilia and systemic symptoms
13. Patients with congenital conditions: congenital glucose-6-Phosphate dehydrogenase deficiency of the erythrocytes, haemoglobin anomalies such as Hb Köln and Hb Zürich
14. Patients with acute porphyria
15. Any clinical condition which the investigator considers would make the patient unsuitable for the trial.

    * It is common for these investigations to change in patients with cirrhosis and long-term ascitic drains may be removed. Patients can be re-screened for eligibility if this occurs.
Sonographic Hysterosalpingography: Oil vs Water Based Media (SHOW Trial)

Performing fluoroscopic HSG with oil based contrast medium has been shown to increase pregnancy rates in a subfertile population. This is a pilot study to test the efficacy of as well as the tolerability and safety of using lipid based oil medium for sonographic based hysterosalpingography (Sono HSG) compared to water based contrast (i.e. normal saline) for women seeking fertility. The double blind study will randomize 56 women at the time of Sono HSG in a 1:1 ratio to receive through the SHG catheter either up to 10 cc of Lipiodol UF® or normal saline. The investigators will collect subjective pain experience and follow the subjects for 6 months after the test for pregnancy and collect all adverse events during and after the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for Sono HSG for fertility testing
* In good general health
* Willing and capable of complying with the study procedures
* At least one patent tube and no endometrial pathology on Sono HSG
* Ready to undergo infertility treatment immediately after the test
* Not planning on IVF therapy in the next 6 mos

Exclusion Criteria:

* Known tubal or endometrial (polyp, submucous fibroid, etc.) pathology
* At high risk for tubal disease due to history of Pelvic Inflammatory Disease
* Known hypersensitivity to Lipiodol UF®or known allergy to iodine containing contrast media or shellfish
* Endometrial pathology on Sono HSG requiring further evaluation (as per the performing physician)
* Bilateral tubal occlusion on Sono HSG
* Unable to tolerate potential pain associated with the study.
* Requiring IVF due to severe male factor, known pelvic adhesions, etc.
* Couples with decreased male factor fertility rate (i.e., low sperm count or motility, i.e. less than 5 million/mL concentration on semen analysis
Aveir VR Coverage With Evidence Development Post-Approval Study

The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Single-Chamber Leadless Pacemaker device (Aveir VR LP).

This is a non-randomized, multi-center study leveraging real-world evidence methods that merge multiple real-world datasets from Abbott and the Center for Medicare Services to compare Aveir VR LP safety and health outcomes to those in patients implanted with single-chamber transvenous pacemakers in a large patient population.

The study will enroll all Medicare patients implanted with the Aveir VR LP and, as the control group, patients implanted with a single-chamber ventricular transvenous pacemaker from any manufacturer.

Eligibility Criteria:
The study cohort will include all Medicare patients with continuous claims data implanted with an Aveir VR leadless pacemaker or a full-system single-chamber ventricular transvenous pacemaker (from any manufacturer) in any US location

Inclusion Criteria:

Medicare beneficiaries implanted with an Aveir VR leadless pacemaker on or after the study start date (i.e., the date of Aveir VR market approval) will be included in the study.

OR

Medicare beneficiaries implanted with a full system (e.g. lead and generator) single-chamber ventricular transvenous pacemaker on or after the study start date

Exclusion Criteria:

None
Decision-making Regarding the Possibility of Medical Termination of Pregnancy

The aim of this study is to improve professional practices by better understanding parents who face the choice of medical termination of pregnancy.

The hypothesis of the study is that the decision to continue the pregnancy with a serious fetal pathology is more based on the belief and the representations of parents than on the diagnosis or prognosis criteria of the fetus.

A better understanding of the parents' motivations on their decision making by knowing what they expect from the caregivers would allow the division of representations, a better prenatal advice and a better perinatal support.


Eligibility Criteria:
Inclusion Criteria:

* Adults without age limit
* Couples or single mothers seen at hospital in 2019
* Couples or single mothers who have been taken care at the Antenatal Diagnosis Center
* Couples or single mothers whose file has been presented to a Multidisciplinary Prenatal Diagnosis Center (MPDC)
* MPDC's legal authorization of medical termination of pregnancy for severe fetal pathology (fetal reason)

Exclusion Criteria:

* MPDC's legal authorization of medical termination of pregnancy for maternal reason
* Parents who have requested an opinion on another MPDC (with continuation of care in another center)
* Fetal death in utero before couple's decision to continue or terminate the pregnancy
* Psychiatric pathology preceding the pregnancy
* Non-affiliation to health insurance plan
* No possible communication (language barrier)
* Participation refusal
* Adult patient protected under the terms of the law (Public Health Code)
CathOlic Medical Center percutAneous Coronary inTervention Registry (COACT)

COACT registry is a multicenter registry of consecutive patients undergoing coronary stent implantation at 8 centers in the Catholic University of Korea to evaluate the real world management of patients with coronary artery disease and to assess their in-hospital, medium and long-term outcomes.


Eligibility Criteria:
Inclusion Criteria:

* all consecutive patients who underwent percutaneous coronary intervention
* written informed consent for the DNA and serum databank

Exclusion Criteria:

* patients who did not agreed to participate