cyrilzakka/clinical-trials huggingface dataset:
IntraVitreal Triamcinolone Acetonide: Preventing Raised Eye-pressure by Tracking Elevations After Topical Steroids

Intravitreal triamcinolone acetonide (IVTA) is a commonly employed treatment for various vitreoretinal disorders. However, approximately 23% to 50% of patients who receive IVTA develop ocular hypertension after the drug is injected into the eye. Similar to IVTA, topically administered corticosteroids eye drops result in ocular hypertension in approximately 33% of the population. It is unknown whether identifying patients who develop ocular hypertension from topical corticosteroids could be used to identify patients who are at risk for injectable IVTA. Therefore, the purpose of this study is to evaluate the efficacy of topical prednisolone 1% four times daily for one month as a screening test to reduce the incidence and severity of ocular hypertension after IVTA injection.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with vitreoretinal disease for which IVTA has been chosen as treatment

Exclusion Criteria:

* \< 18 years old
* Pregnancy
* Breast feeding
* hx of uveitis
* hx of neovascularization of the iris or anterior chamber angle
* hx of ocular herpes simplex keratitis
* hx of glaucoma
* Unable to provide informed consent
Incorporating ePrognosis for the Encouragement of Smarter Screening for Breast and Colorectal Cancer in Older Adults

This clinical trial assesses the feasibility and acceptability of a smarter screening intervention for breast and colorectal cancer in older adults. This study aims to learn more about how to support patients and physicians in making cancer screening decisions for older adults.

PRIMARY OBJECTIVES:

I. Complete development of and refine "Smarter Screening", a multi-component, patient-centered intervention centered around ePrognosis: Cancer Screening to facilitate shared decision-making screening discussions for breast and colorectal cancer in older adults.

II. Assess feasibility and acceptability of the "Smarter Screening" intervention and assess its impact versus usual care on shared decision-making about whether or not to continue breast and colorectal cancer (CRC) screening among multi-ethnic and socioeconomically diverse primary care patients.

EXPLORATORY OBJECTIVES:

I. Impact on breast and CRC screening versus usual care.

II. Risk perception, worry, and a patient-reported measure of decision quality.

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM I: Participants receive Passport to Health booklet and complete ePrognosis before scheduled primary care visit.

ARM II: Participants receive usual care before scheduled primary care visit.

After completion of study, participants are followed up at 1 week post primary care visit.

Eligibility Criteria:
Inclusion Criteria:

* Age 70 years and above
* Ability to understand study procedures and to comply with them for the entire length of the study
* Ability of individual to understand a written informed consent document, and the willingness to sign it
* Have no prior history of cancer
* Scheduled for an upcoming appointment in University of California, San Francisco (UCSF) General Internal Medicine or Women's Health Primary Care clinics
* English-speaking

Exclusion Criteria:

* Contraindication to any study-related procedure or assessment
* Non-English speaking
* Are under the current medical care of either the study primary investigator (PI) or co-investigator (Co-I)
Bioequivalence Study of Prednisolone and Dexamethasone

The purpose of this study is to compare two different glucocorticoids, prednisolone and dexamethasone at two different doses for their organ specific effects, utilizing modern day standards.

Study design: A randomised, double blind, cross-over clinical trial.

Study population: healthy human adult volunteers including 12 males and 12 females aged 18-75 years old.

Intervention: In random order, subjects will receive 7,5 mg prednisolone for one week, directly followed by 30 mg of prednisolone for one week. After a washout period of 4 weeks (or by exception 8 weeks), subjects will receive 1,125 mg dexamethasone for one week, directly followed by 4,5 mg dexamethasone for one week.

Main study parameters/endpoints: The main study endpoint is the difference in total urinary cortisol excretion as measured in 24h-urine between the lower doses of prednisolone and dexamethasone as well as between the higher doses of prednisolone and dexamethasone.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be healthy with no relevant medical history and no use of medication.
* Female participants aged \<50 years must be using oral contraceptives and female participants age ≥50 years must be in the postmenopausal state
* Command of the Dutch language
* Providing written IC
* BMI between 18.5 and 30 kg/m2
* Participants must be between 18 and 75 years of age

Exclusion Criteria:

* Potential participants who are unlikely to adhere to the study protocol (for instance subjects which have a history of substance abuse or non-compliance)
* Potential participants with a medical history of:

  1. Diseases affecting the HPA-axis: e.g. primary and secondary adrenal insufficiency, pituitary tumors, and nightshift workers
  2. Diseases affecting the HPG-axis: e.g. Cushing disease.
  3. Chronic inflammatory diseases: e.g. rheumatoid arthritis, polymyalgia rheumatic, and asthma
  4. Psychiatric diseases
  5. Diabetes
* Shift workers
* Potential participants with a kidney function \<60 ml/min/1.73m2, abnormalities in liver enzymes, and/or abnormalities in thyroid function
* Potential participants who are dependent on corticosteroids, e.g. asthmatic patients, and transplant recipients
The Safety and Efficay Investigation of CAR-T Cell Therapy for Patients with Hematological Malignancies

To evaluate the tolerability and safety of CAR-T technology in patients with relapsed or refractory hematolymphoid malignancies.

Main research purposes:

To evaluate the tolerability and safety of CAR-T technology in patients with relapsed or refractory hematolymphoid malignancies.

Secondary research purposes:

Objective Evaluation of Cytodynamic Characteristics of CAR-T in Different Types of Hematological Malignancies

Eligibility Criteria:
Inclusion Criteria:

* Sign the informed consent and be willing and able to comply with the visit, treatment protocol, laboratory examination, and other requirements of the study as specified in the study procedure sheet;
* Diagnosed as recurrent or refractory lymphoma, leukemia or myeloma;
* Tumor cells express targets for CAR-T cell therapy (results: flow cytometry or Immunohistochemical test confirmation);
* Age 14-75 (including threshold), gender unlimited;
* Eastern Cooperative Oncology Group (ECOG) score ≤2;
* HGB ≥ 70g/L (blood transfusion allowed);
* Liver and kidney functions, heart and lung functions meet the following requirements:

  1. Creatinine ≤ 1.5 × ULN;
  2. Left ventricular ejection fraction ≥ 50%;
  3. Blood oxygen saturation\>90%;
  4. Total bilirubin ≤ 1.5 × ULN； ALT and AST ≤ 2.5 × ULN;
* For T cell tumor patients, if tumor cells are detected in peripheral blood during screening, flow cytometry should be used to detect that the tumor cell surface immunophenotype is CD4 and CD8 double negative. If the immunophenotype of peripheral blood tumor cells is not double negative for CD4 and CD8, the condition that the proportion of peripheral blood tumor cells is ≤ 1% shall be met;
* Subjects with pregnancy plans must agree to use contraception before entering the study and after the study lasts for six months; If the subject is pregnant or suspected of being pregnant, the investigator shall be informed immediately;
* The subject or guardian understands and signs the informed consent form;
* Expected survival longer than 3 months.

Exclusion Criteria:

* Severe cardiac insufficiency;
* Have a history of severe lung impairment;
* Complicated with other advanced malignant tumors;
* Complicated with severe or persistent infection that cannot be effectively controlled;
* Complicated with severe autoimmune diseases or congenital immune deficiency;
* Active hepatitis (HBV DNA or HCV RNA positive);
* Human immunodeficiency virus (HIV) infection or syphilis infection;
* Have a history of severe allergy to biological products (including antibiotics);
* If there is a history of hematopoietic stem cell transplantation, it should be no more than 6 months before the patient receives allogeneic hematopoietic stem cell transplantation;
* Subjects who received CAR-T therapy or other gene modified cell therapy before screening;
* Conditions that the investigator believes may increase the risk to the subject or interfere with the outcome of the study.
Effect of CNSI vs. ICG in Lymph Node Tracing During Gastrectomy

The purpose of this study is to assess the efficacy and safety of carbon nanoparticle suspension injection and indocyanine green tracer-guided lymph node dissection during gastrectomy in patients with gastric cancer

Da Vinci robot surgery XI system has fluorescence imaging function, which can realize indocyanine green lymph node tracking navigation technology in the operation. At the same time, the lymph node tracking effect of nano carbon suspension injection is not affected by equipment. The flexible mechanical arm of Da Vinci robot combined with the application of lymph node tracing technology makes the lymph node dissection of gastric cancer surgery more thorough, and also reduces the difficulty of surgery. Indocyanine green navigational lymphadenectomy can also be performed by fluorescence laparoscopy. By comparing the two tracer techniques, the lymph node tracer technique which is more suitable for robot or laparoscopic surgery system is selected to provide help and choice for clinical surgeons.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 18 to 75 years
2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
3. clinical stage tumor 1-4a (cT1-4a), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
4. No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
5. Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
6. American Society of Anesthesiology score (ASA) class I, II, or III
7. Written informed consent

Exclusion Criteria:

1. Women during pregnancy or breast-feeding
2. Severe mental disorder
3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
4. History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
5. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
6. History of other malignant disease within past five years
7. History of previous neoadjuvant chemotherapy or radiotherapy
8. History of unstable angina or myocardial infarction within past six months
9. History of cerebrovascular accident within past six months
10. History of continuous systematic administration of corticosteroids within one month
11. Requirement of simultaneous surgery for other disease
12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
13. FEV1\<50% of predicted values
14. Diffuse; widespread; plastica
A Single-Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Ropinirole 0.25 mg Tablets Under Fed Conditions

The objective of this study was to assess the single dose bioequivalence of Roxane's Ropinirole tablets,0.25 mg, to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fed conditions using a single dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.

The objective of this study was to assess the single dose bioequivalence of Roxane's Ropinirole tablets,0.25 mg, to ReQuip Tablets, 0.25 mg (GlaxoSmithKline) under fed conditions using a single dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.

Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to ropinirole or any other comparable product.
Mortality in Cancer Patients Admitted to the Intensive Care Unit in a Resource-limited Setting

The purpose of this study is to determine 30 day mortality in cancer patients admitted to the intensive care unit in a resource limited setting.

The management of cancer patients in the intensive care unit (ICU) has changed dramatically during the last two decades. Initial experiences showed high rates of hospital mortality, reaching up to 75-85% in patients requiring life-sustaining treatments, particularly mechanical ventilation. An increasing number of clinical experiences has been reported pointing to a significant improvement in survival of these patients. However, it is not clear if this results are generalizable to settings with resource constraints. Therefore, the purpose of this study is to determine 30 day mortality in cancer patients admitted to the intensive care unit in a resource limited setting.

This study is a prospective cohort of cancer patients admitted to the ICU in which the investigators will evaluate the prognostic of cancer patients admitted for a ICU trial or treatment in ICU without limitations. This study will not consider any change in the treatment plan of the patients. The source of the data will be the clinical records of the patients during the admission and the records of the cancer unit. There will be no direct contact of the research team with the patients or their family.

Eligibility Criteria:
Inclusion Criteria:

* 18 years-old or older
* Histological diagnosis or high clinical suspicious of cancer (solid /hematological), with the exception of non-melanoma skin cancer.
* Functional classification state between 0-3, according to Eastern Cooperative Oncology Group.
* Admission to intensive care unit, because of one or more of the following criteria:

  1. Invasive or non-invasive ventilatory support due to acute respiratory failure.
  2. Use of vasopressor drugs due to hypotension defined as noradrenaline requirement higher than 0.1 microgram/Kg/min.
  3. Renal replacement therapy due to acute renal failure.

Exclusion Criteria:

* Absence of cancer recurrences in more than 5 years after diagnosis
* Functional classification state of 4, according to Eastern Cooperative Oncology Group.
Impact of Everolimus on HIV Persistence Post Kidney or Liver Transplant

Zortress (everolimus), the 40-O-(2-hydroxyethyl)-derivative of rapamycin, is an mTOR inhibitor approved for rejection prophylaxis in kidney transplant recipients. mTOR inhibition may favorably impact the HIV viral reservoir, and we hypothesize that adding everolimus to the transplant immunosuppressive regimen of HIV positive transplant recipients will decrease HIV persistence in CD4+ lymphocytes.

Open-label, single arm study that will enroll antiretroviral-treated HIV-infected adults who are doing well post-liver or post-kidney transplant who are eligible and willing to add everolimus to their immunosuppressive regimen (with a target trough level between 3-8 ng/ml). Calcineurin inhibitors will be decreased to obtain a 50% reduction in trough levels with the addition of everolimus. Subjects will be maintained on that regimen for 6 months.

Biologic specimens for intensive immunology and virology studies will be obtained before, during and after exposure to everolimus. Samples will be analyzed at screening, baseline (prior to addition of everolimus), and at weeks 8 and 26 (while on everolimus), and week 52 (6 months post everolimus discontinuation).

Eligibility Criteria:
Inclusion Criteria:

1. Solid organ (kidney, kidney/pancreas, or liver) transplant recipient
2. Male or female ≥ 18 years of age.
3. Documentation of HIV-1 infection diagnosis as evidenced by any licensed ELISA and confirmation by Western Blot, or documented history of detectable HIV-1 RNA)
4. HIV-1 plasma RNA \<50 copies/ml for at least 2 years with at least one measurement per year and most recent viral load within 16 weeks of enrollment and study drug initiation. Episodes of a single HIV plasma RNA 50 - 500 copies/ml will not exclude participation if the subsequent HIV plasma RNA was \<50 copies/ml.
5. CD4+ T cell counts greater than 200 cell/µl within 16 weeks of enrollment and study drug initiation.
6. Receiving combination antiretroviral therapy (at least 3 agents)
7. Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

1. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.
2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
3. Patients who are intending to modify antiretroviral therapy in the next 6 months for any reason.
4. Serious illness requiring hospitalization or parenteral antibiotics within preceding 3 months.
5. A screening hemoglobin below 11.5 g/dL.
6. A screening TSH consistent with hypothyroidism.
7. Significant renal disease (eGFR \< 60 ml/min) or acute nephritis
8. Clinically active hepatitis as evidenced by clinical jaundice or Grade 2 or higher liver function test abnormalities.
9. Hepatic cirrhosis or decompensated chronic liver disease.
10. Concurrent treatment with immunomodulatory drugs, such an interferon-alpha, or exposure to any immunomodulatory drug in past 16 weeks (outside of standard immunosuppression).
Peri-urethral Bulk Agent Injection of Bulkamid®

There are currently different treatment options in the management of stress urinary incontinence according to the latest recommendations \[1\]. Suburethral slings are currently considered the first surgical option due to an excellent cure rate of around 90%. Nevertheless, due to a risk of prosthetic complications and numerous current controversies over the placement of synthetic tissue, other therapeutic alternatives must be offered to patients \[2\].

Peri-urethral bulk agent injections have been used since 2006 in urinary incontinence and should be integrated into the therapeutic arsenal. This is a minimally invasive technique performed under local anesthesia on an outpatient basis. The mechanism of action is explained by better coaptation of the urethra and increased resistance to urine flow during the bladder filling phase. It also increases the strength of the striated sphincter thanks to a better arrangement of muscle fibers \[3\].

According to the European Association of Urology (EAU), the use of bulk agents is recommended for the management of urinary incontinence in elderly and/or frail patients whose comorbidities contraindicate surgical management. These peri-urethral injections can also be offered to patients with incontinence due to sphincter deficiency but also to young women with stress urinary incontinence who are ready to accept a partial improvement in their incontinence \[1\]. The personal choice of the patient is currently a decisive factor for the implementation of a treatment for functional disorders and in particular for urinary incontinence.


Eligibility Criteria:
* Inclusion Criteria :

  * women over 18
  * patients who received a first peri-urethral injection of Bulkamid® in the context of urinary incontinence
  * intervention between September 2020 and November 2022
  * person having expressed his non-opposition
* Exclusion Criteria :

  * inability to understand the information given
  * person deprived of liberty
  * person under guardianship
Assessment of Efficacy and Safety of Monalizumab Plus Cetuximab Compared to Placebo Plus Cetuximab in Recurrent or Metastatic Head and Neck Cancer

This is a randomized, double-blind, multicenter, global Phase 3 study to assess the efficacy and safety of monalizumab and cetuximab, compared to placebo and cetuximab, in Participants with recurrent or metastatic head and neck cancer.

Participants with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) who had prior immune checkpoint inhibitor and platinum-based chemotherapy treatment will be randomized in a 2:1 ratio to monalizumab and cetuximab or placebo and cetuximab. Efficacy and safety assessments will be performed periodically from the time of enrollment and throughout the study. Participants in all arms will continue therapy until progression, unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. All Participants will be followed for survival after progression is confirmed.

Eligibility Criteria:
Inclusion Criteria:

* Are aged 18 years and over
* Recurrent or metastatic squamous cell carcinoma of the SCCHN, oral cavity, oropharynx, hypopharynx, or larynx which has progressed on or after previous systemic cancer therapy and is not amenable to curative therapy
* Received prior treatment using a programmed cell death ligand-1 (PD-L1) inhibitor
* Prior platinum failure
* Received 1 or 2 prior systemic regimens for recurrent or metastatic SCCHN
* Has measurable disease per RECIST 1.1
* A fresh or recently acquired tumor tissue for the purpose of biomarker testing
* World Health Organization (WHO)/ Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

* Head and neck cancer of any primary anatomic location in the head and neck not specified in the inclusion criteria, including participants with SCCHN of unknown primary or non-squamous histologies
* Had prior cetuximab therapy (unless it was administered in curative locally advanced setting with radiotherapy and no disease progression for at least 6 months following the last cetuximab dose)
* Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[eg, colitis or Crohn's disease\], diverticulitis
* Any concurrent anticancer treatment, except for hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy)
A Pilot Study Using Text Messaging to Communicate With Adolescent Females in the Pediatric Emergency Department

The objective of this study is to develop and test an emergency department (ED)-based intervention which uses text messages to facilitate contraception initiation.

Our hypothesis is that adolescent females at high pregnancy risk who receive text message reminders and motivational messages that promote contraception and referral to the Family Planning Clinic are more likely to start effective contraception than those who receive standard paper-based referral to the Family Planning Clinic alone.

Eligibility Criteria:
Inclusion Criteria:

* Aged 14-19 years
* Sexually active with males in the past three months
* Presenting to the ED for a reproductive health complaint.

Exclusion Criteria:

* Presently pregnant
* Too ill for participation per the attending physician
* Cognitively impaired
* In foster care or a ward of the state
* Does not speak English or Spanish
* Does not own a cellular or mobile phone with text messaging capabilities
* Used contraception at last intercourse and/or is currently using any "highly effective" or "effective" form of contraception (as defined by the World Health Organization)
* Does not live in Manhattan or the Bronx