cyrilzakka/clinical-trials huggingface dataset:
Study of RP1 Monotherapy and RP1 in Combination With Nivolumab

RPL-001-16 is a Phase 1/2, open label, dose escalation and expansion clinical study of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors, to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), as well as to evaluate preliminary efficacy.

RP1 is a genetically modified herpes simplex type 1 virus that is designed to directly destroy tumors and to generate an anti-tumor immune response. This is a Phase 1/2, open label, multicenter, dose escalation and expansion, first-in-human (FIH) clinical study to evaluate the safety and tolerability, biodistribution, shedding, and preliminary efficacy of RP1 alone and in combination with nivolumab in adult subjects with advanced and/or refractory solid tumors. The study will include a dose escalation phase for single agent RP1, an expansion phase with a combination of RP1 and nivolumab and a Phase 2 portion in specified tumor types for the combination therapy.

Eligibility Criteria:
Inclusion Criteria:

* Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
* At least one measurable and injectable lesion
* Have provided a former tumor pathology specimen or be willing to supply a new tumor sample from a biopsy
* Have a predicted life expectancy of ≥ 3 months
* Measurable disease, according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
* Subjects with MSI-H or dMMR tumors: has diagnosis of MSI-H or metatstatic dMMR tumor (according to protocol definition) who has progressed on prior anti-PD1/PD-L1 therapy.
* Subjects with NMSC: has diagnosis of locally advanced or metastatic NMSC that are not considered treatable by surgery including basal cell carcinoma, cutaneous squamous cell carcinoma, basosquamous carcinoma, Merkel cell carcinoma and other non-melanoma skin cancers (per protocol). Patients must have received 8 weeks of anti-PD1/PD-L1 as their last line of therapy and progressed while on treatment.
* Subjects with anti-PD1 failed cutaneous melanoma: has confirmed progressive disease while on anti-PD1 treatment for at least 8 weeks and documented BRAF mutation status
* Subjects with anti-PD1 failed NSCLC: must have failed prior treatment, including PD1/PD-L1 directed therapy administered either as monotherapy or in combination with platinum-based chemotherapy or anti-CTLA-4. The most recent treatment given must have included an anti-PD1/PD-L1 directed therapy with radiologic disease progression on or after treatment.

Exclusion Criteria:

* Prior treatment with an oncolytic therapy
* History of viral infections according to the protocol
* Prior complications with herpes infections
* Chronic use of anti-virals
* Uncontrolled/untreated brain metastasis
* History of interstitial lung disease
* History of non-infectious pneumonitis
* History of clinically significant cardiovascular disease
Epidemiology of Merkel Carcinomas in the Bas-Rhin

The aim of this work is to study demographic, clinical, management (diagnostic and therapeutic) and survival data concerning patients with Merkel's carcinoma in the Lower Rhine, thus obtaining the first French data.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Diagnosis of primary Merkel carcinoma (topographic code C44 morphological code 8247/3)
* Diagnosis made between 1983 and 2011
* Patient residing in the Bas-Rhin at the date of diagnosis
* Patient who has given his consent for the use of his data for research purposes

Exclusion Criteria:

- Refusal to participate in research
Continuation of Anti-osteoporotic Treatment 1 Year After Initial Administration

The aim of this observational study is to assess the obstacles and levers to the continuation of anti-osteoporotic treatment, and to identify those where action could be taken to improve the quality of care for fractured patients.

The individual and collective stakes are high. Fracture is the most feared complication of osteoporosis. The current under-diagnosis and under-treatment of this chronic pathology exposes patients to a high risk of early re-fracture, with the associated morbidity and mortality.

General practitioners have a major role to play in monitoring and coordinating patients' healthcare pathways. The aim of this study is to assess ways of improving osteoporosis management in order to improve quality of life and disability-free life expectancy for individual patients. The public health and economic stakes are equally high. It is by identifying the obstacles that prospective work on the key elements to be implemented could help optimize osteoporosis management.

Selection of patients hospitalized at the Rocheplane Medical Center between June 2021 and May 2022, following a severe osteoporotic fracture and having received a first dose of antiosteoporotic treatment during their overall stay (initial admission department + CMR).

Sending of an information letter and request for non-objection from patients or their trusted support person, with a 1-month cooling-off period to express opposition.

Collection of variables of interest from CMR patients' medical records, followed by administration of a telephone hetero-questionnaire (transferred to Excel) to patients or their families 1 year after fracture occurrence.

If the patient or family did not answer the questionnaire, or if it was incomplete (missing data), the information could be sought by telephone from the attending physician.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalization in CMR's Geriatric Rehabilitation Department between 01/06/2021 and 31/05/2022
* Age: 75 and over
* Admitted with severe post-fracture osteoporosis
* Having received a first dose of antiosteoporotic treatment between the day the fracture occurred and discharge from CMR (either in an inpatient unit prior to CMR, or at CMR)

Exclusion Criteria:

* Having objected to the use of his/her data for research purposes
* Subject under guardianship or deprived of liberty.
* Pathological fracture
* Anti-osteoporotic treatment prior to fracture
* 1-year follow-up made impossible by lack of contact with patient, family or attending physician.
Wellness & Workforce Solution for Lupus/Lupus Nephritis

The investigators will test the hypothesis that culturally congruent coaching delivered via a technology application (Health360x) will improve the persistent disparities observed among women of color with lupus or lupus nephritis by addressing underlying psychosocial barriers to behavioral change.

The investigators' proposed intervention combines technology with culturally congruent coaching (C3) to increase access and engagement of women of color with lupus through remote instruction. The investigators will test the hypothesis that culturally congruent coaching delivered via a technology application (Health360x) will improve the persistent disparities observed among women of color with lupus or lupus nephritis by addressing underlying psychosocial barriers to behavioral change. The investigators will attain this by connecting patients to extensively trained coaches who have lived experiences that clinicians and providers often lack. These shared social and cultural experiences breeds trust and allows for more open communication that the coach can use to provide more appropriate guidance. Leveraging technology, the investigators' program is asynchronous, promotes engagement and retention of information through micro-learning, and allows the investigators to better understand patient experiences beyond structured surveys by capturing what is happening in the patient-coach relationship.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. females ; Age over 18yo
4. Self-reported diagnosis of Lupus or Lupus Nephritis, or documented diagnosis of Lupus or Lupus Nephritis
5. Willingness to adhere to the study intervention regimen
6. Access to necessary resources for participating in a technology-based intervention (i.e., computer, smart-phone, internet access)
7. Not currently practicing self-management behaviors and have not participated in a class or program on self-management behavior within the last 12 months

Adult women with lupus and lupus nephritis will be enrolled in the study. Eligibility: Adult women with lupus and lupus nephritis who are able to consent and participate in self-management support training. Access to the internet is required for this intervention. Ability to read English is required because all the materials are currently in English.

Coaches must meet all of the following criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for duration of study
3. Women of color with lupus or lupus nephritis with desire to help others
4. Ability to communicate in English
5. Secure access to Internet
6. Private space for conducting participant visits
7. Ability to use internet-based platform

Exclusion Criteria:

-Potential participants and coaches who are unable to speak or read English, access the internet, or complete data collection activities will be ineligible for participation.
School Response to Families Who Have Children With Cancer

The purpose of this research is to investigate school response to families who have children with cancer. It is anticipated that the results of this study will enhance the support that schools can give to the population of families who have a child with cancer. The study will involve the parents in these families, the principal and an educator in the school of the child with cancer. Measurement tools will include surveys, interviews, and other relevant educational and medical documents.


Eligibility Criteria:
Inclusion Criteria:

* Patients will not be recruited. Only parents, the school principals and the teachers will be recruited.
* Subjects will be 15 sets of parents who have had school-age children treated for cancer within the last 5 years.
Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial

The study will be double blind with respect to rifaximin, and randomization will be performed using tables of computer-generated random numbers. All subjects will be followed up till the recovery of HE (primary end point) or 10 days whichever is earlier. In the Lactulose group (group A) patients will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient passes 2-3 semisoft stools per day along with placebo . In the lactulose plus rifaximin group (group B) patients will receive cap rifaximin 400mg three times a day along with lactulose. Primary endpoints will be recovery of overt HE patients who will not recover from HE after 10 days will be continued on the same treatment. Total duration of the study is 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis
* Age 18-80
* Hepatic encephalopathy grade II-IV
* Informed consent

Exclusion Criteria:

1. Degenerative CNS disease or major psychiatric illness
2. Serum creatinine \> 1.5 mg/dl
3. Active alcohol intake \<4 weeks prior to present episode
4. Others metabolic encephalopathies
5. Hepatocellular Carcinoma
6. Severe comorbidity such as CHF, Pulmonary disease, Neurological \& Psychiatric problems impairing quality of life
Prostate Cancer Education in African American Men

This study evaluates the efficacy of a tailored telephone intervention to promote informed decision making about prostate cancer testing among predominantly immigrant black men.

African American and African-Caribbean men have the greatest prostate cancer incidence and mortality rate. Professional organizations provide conflicting recommendations regarding prostate cancer testing but generally agree that men learn about the risks and benefits of testing and share in decisions about testing based on their personal preferences. This study was designed to assess the effects of a decision support intervention on men's knowledge about prostate cancer testing, participation in medical decisions about testing, decision conflict related to testing, and the congruence between prostate cancer testing intentions and behaviors. A randomized controlled trial was conducted. Participants were randomized into one of two conditions: (a) tailored telephone education about prostate cancer testing (intervention group) or (b) tailored telephone education about national guidelines for fruit and vegetable consumption (attention control group).

Eligibility Criteria:
Inclusion Criteria:

* 45 to 70 year old
* African descent
* accessible by telephone
* have primary care physician

Exclusion Criteria:

* Prostate cancer test in 12 months prior to enrollment
* History of prostate cancer
Evaluating the Effectiveness of Interactive SMS Reminders on TB Treatment Outcomes

In this study, Interactive Research and Development (IRD) in Karachi, Pakistan is evaluating the impact of Interactive Reminders on drug compliance and treatment outcomes. Interactive Reminders is an interactive SMS reminder system to help patients remember to take their TB medication. In this system, patients receive daily SMS reminders for the duration of their treatment at a pre-specified time, reminding them to take their medication. Patients are asked to reply back to the system, either through SMS or a missed call, with the time they took their medicine that day. If a response is not received within two hours, a second reminder is sent. If a response is still not received in a further two hours, a third and final reminder for the day is sent. Non-responsive patients are followed up with phone calls and a list of non-responsive patients is shared with clinics based on the parameters of non-responsiveness that they specify.

IRD seeks to determine the impact of this system on treatment outcomes and compliance to prescribed medication through administering a randomized control trial among newly diagnosed TB patients in Karachi, Pakistan.


Eligibility Criteria:
Inclusion Criteria:

* New, smear-positive drug susceptible TB who have been on treatment for less than two weeks
* Access to a mobile phone (self-reported)
* Intending to reside in Karachi for the duration of their treatment

Exclusion Criteria:

* Patients who do not have regular access to a mobile phone
* Patients who have previously received TB treatment
* Patients who have another member in their household who is already a part of the study
Intravitreal Injection Versus Sub-Tenon's Infusion of Triamcinolone Acetonide for Refractory Diabetic Macular Edema During Cataract Surgery

Triamcinolone has already been used by different routes of administration to treat diabetic macular edema. In the present study, intravitreal injection (IVI) and posterior sub-Tenon's infusion (STI) of triamcinolone acetonide (TA) during phacoemulsification cataract surgery in eyes with refractory diffuse diabetic macular edema are tested.


Eligibility Criteria:
Inclusion Criteria:

* Refractory diffuse DME unresponsive to focal laser photocoagulation
* Best corrected visual acuity between 20/800 and 20/40; Central subfield macular thickness greater than 300 µm

Exclusion Criteria:

* Previous ocular surgery
* Glycosylated hemoglobin (Hb A1C) rate above 10%
* History of glaucoma or ocular hypertension
* Loss of vision as a result of other causes
* Systemic corticoid therapy
* Severe systemic disease
* Any condition affecting follow-up or documentation
Preemptive and Preventive Acetaminophen/Ibuprofen Fixed-dose Combination After Robot-assisted Radical Prostatectomy

This prospective, randomized, double-blinded study is designed to compare opioid-sparing effect of preemptive and preventive intravenous acetaminophen/ibuprofen fixed-dose combination in patients undergoing robot-assisted radical prostatectomy (RARP). We hypothesize that preemptive administration of intravenous acetaminophen/ibuprofen fixed-dose combination can significantly reduce postoperative opioid consumption and pain severity than preventive administration in patients undergoing RARP.

Adult patients undergoing elective robot-assisted radical prostatectomy are randomly allocated to receive preemptive administration of acetaminophen (1000 mg)/ibuprofen (300 mg) fixed-dose combination (n=77) or preventive administration (n=77). The preemptive administration group will receive intravenous acetaminophen (1000 mg)/ibuprofen (300 mg) for 15 minutes at the end of induction of anesthesia. The preventive administration group will receive same dosage of drug for same duration when surgical site closure starts.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo elective robot-assisted radical prostatectomy under general anesthesia
* American Society of Anesthesiologists (ASA) physical classification I-II
* Consent to IV-patient controlled analgesia use
* Willingness and ability to sign an informed consent document

Exclusion Criteria:

* Who do not understand or agree with our study
* American Society of Anesthesiologists (ASA) physical classification III-IV
* Chronic usage of opioid analgesics
* Moderate to severe pain with other cause before surgery
* Allergies to anesthetic or analgesic medications used in this study
* Anticipated blood loss larger than 2 liters
* Need for intensive care after surgery
* History of gastric ulcer or gastrointestinal bleeding
* History of liver failure, renal failure or heart failure
* Current alcoholism
* Taking anti-coagulation drugs or history of coagulation disease
* History of bronchial asthma
* Medical or psychological disease that can affect the treatment response
* Taking barbitutate or tricyclic antidepressant
Efficacy and Safety Study of a Steroid/Antibiotic Combination Eyedrop to Treat Non-Bacterial Blepharitis

The purpose of this study is to evaluate the clinical efficacy and safety of ISV-502 compared to AzaSite® alone, Dexamethasone alone, and vehicle in the treatment of subjects with Non-bacterial Blepharitis.


Eligibility Criteria:
Inclusion Criteria:

* Are at least 18 years of age at Visit 1 (Day 1, Baseline) of either sex and any race.
* Signature of the subject or legally authorized representative on the Informed Consent Form.
* Are willing and able to follow all instructions and attend all study visits.
* Are willing to avoid disallowed medication for the duration of the study.
* If female is of childbearing potential, agree to and submit a urine sample for pregnancy testing. Post menopausal is defined as having no menses for at least 12 consecutive months.
* Additional inclusion criteria also apply.

Exclusion Criteria:

* Have known sensitivity or poor tolerance to any component of the Investigational Drug.
* Have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation other than Blepharitis in the study eye.
* Have used topical corticosteroid medications or topical ophthalmic solutions that the investigator feels may interfere with the study parameters.
* Have used any non-diagnostic topical ophthalmic solutions in the study eye.
* Be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive urine pregnancy test.
* Currently suffer from alcohol and/or drug abuse.
* Have prior (within 30 days of beginning dosing) or anticipated concurrent use of an investigational drug or device.
* Have a condition or a situation which, in the Investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation.
* Additional exclusion criteria also apply.
64Cu/68Ga Labelled EB-ss-CPT PET/CT Scan in Colorectal Cancer

Positron labeled camptothecin based PET imaging is a new imaging technique that uses positron isotopes such as 68Ga/64Cu for PET/CT (MR) imaging. It is expected to have significant clinical significance in staging and detecting primary and metastatic head and neck cancer, oral cancer, and colorectal cancer tumors.

CPT, a botanical anticancer drug, is a mechanism that inhibits DNA synthesis and thus exerts anticancer effects by using topoisomerase I as its target of action, and has shown good efficacy in digestive system tumors and head and neck tumors, etc. Previous research result showed that amphiphilic EB-ss-CPT formed nanoparticles by self-assembly, bound to albumin in vivo and released CPT by breaking disulfide bonds under high GSH conditions in tumor tissues, effectively enhancing the pharmacokinetics and biodistribution of camptothecin, thereby improving therapeutic efficacy and In this study, the sensitivity of colorectal cancer cells to the drug was also demonstrated. In this study, 64Cu-NOTA-EB-ss-CPT (hereafter 64Cu-EB-CPT) was generated by posionuclide 64Cu-labelled EB-ss-CPT for PET/CT imaging alone and showed better tumour enrichment compared to the 64Cu-labelled CPT group. EB-CPT is expected to be more enriched in tumour tissue through the EPR effect of its nanoparticles, and 64Cu is also a promising radionuclide for quantitative analysis using PET/CT imaging. The formation of 64Cu-EB-CPT or 68Ga-EB-CPT by labelling EB-CPT with the positronium nuclide 64Cu or 68Ga is expected to be enhanced by the EPR effect of the precursors (the enhanced permeability and retention effect of solid tumours). The EPR effect (enhanced permeability and retention effect) refers to the tendency of molecules or particles of certain sizes to accumulate in tumour tissue relative to normal tissue) is expected to enrich the drug in the tumour area and allow early diagnosis of tumour patients by PET/CT imaging with the preceding positronuclide 64Cu or 68Ga, which can help in the staging of tumours and the development of treatment plans.

Eligibility Criteria:
Inclusion Criteria:

* In the near future (within 2 months), patients who plan to undergo puncture biopsy or undergo tumor surgical treatment or are clinically highly suspected of cancer (including primary and tumor recurrence and metastasis)
* Able to understand and voluntarily sign informed consent forms, with good compliance

Exclusion Criteria:

* Severe abnormalities in liver and kidney function
* Suffering from claustrophobia or other mental illnesses
* Pregnant, pregnant, and lactating women