cyrilzakka/clinical-trials huggingface dataset:
IDP-023 as a Single Agent and in Combination With Antibody Therapies in Patients With Advanced Hematologic Cancers

This is an open label, Phase 1/2, first-in-human, multiple ascending dose, and dose-expansion study of IDP-023 administered as a single agent and in combination with or without interleukin-2 (IL-2), and with or without isatuximab, daratumumab or rituximab to evaluate the safety, tolerability and preliminary antitumor activity in patients with advanced hematologic cancers.

IDP-023 is an off-the-shelf, allogeneic cell product made of "natural killer" cells, also called NK cells. White blood cells are part of the immune system and NK cells are a type of white blood cell that are known to kill cancer cells.

This is an open label, Phase 1/2, first-in-human, multiple ascending dose, and dose-expansion study of IDP-023 administered as a single agent and in combination with or without interleukin-2 (IL-2), and with or without isatuximab, daratumumab or rituximab to evaluate the safety, tolerability, and preliminary antitumor activity in patients with relapsed and/or refractory advanced multiple myeloma (MM) or non-Hodgkin's lymphoma (NHL), respectively.

The study is divided into a phase 1 dose escalation phase and a phase 2 expansion phase.

Phase 1 (Escalation Phase): The primary objectives of Phase 1 are to define the safety of different IDP-023 containing regimens and to define the recommended regimen and Phase 2 doses (RP2D) of IDP-023.

Phase 2 (Expansion Phase): The objective of the Phase 2 expansion cohort is to evaluate the safety and efficacy of IDP-023 in advanced MM in combination with isatuximab or daratumumab and advanced NHL in combination with rituximab.

Eligibility Criteria:
Key Inclusion Criteria:

* For MM patients: Documented diagnosis of MM requiring systemic therapy and relapsed and/or refractory (R/R) disease after ≥ 3 prior lines of therapy.
* For NHL patients: R/R disease and failed ≥ 2 lines of systemic chemotherapy.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy of greater than 12 weeks per the Investigator.

Key Exclusion Criteria:

* Impaired cardiac function or history of clinical significant cardiac disease.
* Human immunodeficiency virus (HIV) infection, active hepatitis B infection, or hepatitis C infection.
* Active SARS-CoV-2 infection.
* Has untreated central nervous system, epidural tumor metastasis, or brain metastasis.
A Randomized Controlled Study of Postoperative Adjuvant Chemotherapy of Uracil- Tegafur (UFT) Compared With Surgery Alone (NSAS-GC)

This is a controlled study designed to evaluate the efficacy of UFT on survival compared with surgery alone. Patients will be randomly assigned to receive either surgery alone or surgery followed by UFT within 6 weeks after curative resection. To assess treatment response, data on recurrence and survival will be collected for 5 years after enrollment of the last patient. To evaluate safety, data on adverse events will be collected for 16 months after the start of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age 20 to 75
* Performance status 0 , 1, or 2 (ECOG)
* Hematopoietic WBC ≥ 4,000/mm\^3 Platelet ≥ 100,000/mm\^3
* Hepatic AST and ALT ≤ 2 times upper limit of normal(ULN) Total bilirubin ≤ 1.5 times ULN
* Renal BUN ≤1.5 times ULN Creatinine ≤ 1.5 times ULN

Exclusion Criteria:

* Prior anticancer treatment
Indications and Related Factors for Caesarean Delivery, 1996 to 2002.

To study the effect of elective pain relief analgesia in labor on mode of delivery.


Eligibility Criteria:
Inclusion Criteria:

- women in labor

Exclusion Criteria:

* women with special conditions
Diagnostic Evaluation of Urine DNA Methylation/Somatic Mutation Profiling for Upper Tract Urothelial Carcinoma Detection

Clinical trial to determine the efficacy (sensitivity and specificity) of Anchordx's urine DNA methylation/somatic mutation assay for detecting upper tract urothelial carcinoma compared to pathology in patients.

This is a prospective study that involves 8 centers in China and 490 participants. The test analyzes the DNA methylation/somatic mutation profiles of urothelial cancer-specific biomarkers non-invasively using urine specimens collected before invasive diagnosis/treatment. The efficacy (sensitivity and specificity) of the assay for detection of upper tract urothelial carcinoma is evaluated in comparison to pathology or cystoscopy.

Eligibility Criteria:
Inclusion Criteria:

Case group:

* 1.Any male or female patient aged 18 or older.
* 2.Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments.
* 3.Diagnosed with incident upper tract urothelial carcinoma (including renal pelvis carcinoma and ureteral carcinoma) by surgery.
* 4.Able to provide legally effective informed consent.

Control group:

* 1.Any male or female patient aged 18 or older.
* 2.Able to provide urine specimen (100ml for both first void and non-first-void urine) before treatments.
* 3.Diagnosed with urinary disease such as ureteral/renal calculi, ureteral stricture, upper urinary tract polyps, pyelonephritis, urinary tuberculosis.
* 4.Able to provide legally effective informed consent.

Exclusion Criteria:

* 1.Patients had been diagnosed with cancer history.
* 2.Patients diagnosed with cancers unmatched with inclusion criteria cancers.
A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency

The purpose of this study is to determine how participants with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib versus treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.


Eligibility Criteria:
Inclusion Criteria:

* Be 18 years old at the time the informed consent is signed
* Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate that is metastatic
* Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM)
* Be eligible for treatment with physician's choice of comparator treatment (abiraterone acetate, enzalutamide or docetaxel)
* Experienced disease progression after having received 1 prior next generation androgen receptor-targeted therapy
* Have a deleterious mutation in a BRCA1/2 or ATM gene

Exclusion Criteria:

* Active second malignancy, with the exception of curatively treated non melanoma skin cancer, carcinoma in situ, or superficial bladder cancer
* Prior treatment with any PARP inhibitor
* Prior treatment with chemotherapy for metastatic castration-resistant prostate cancer
* Symptomatic and/or untreated central nervous system metastases
* Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would, in the opinion of the investigator, interfere with absorption of study drug
A Prospective Study to Evaluate Continuous Positive Airway Pressure Devices to Reduce Pulmonary Dose

Data collection and assessment on patients with left-sided breast cancer or undergoing lung stereotactic body radiation therapy (SBRT) utilizing continuous positive airway pressure (CPAP) devices.

Lung stereotactic body radiation therapy (SBRT) has emerged as a definitive treatment for patients with early-stage lung cancers as well as for patients with limited metastases to the lung. One challenge with the treatment of the lung is the risk of pulmonary toxicity, particularly for early-stage lungs cancers that are inoperable (those receiving primary lung SBRT) or those with metastatic cancers receiving systemic therapy that may impact pulmonary function (those receiving lung SBRT for metastatic cancers).

Continuous positive airway pressure (CPAP) devices are commonly utilized for patients with obstructive sleep apnea. However, through the use of continuous pressure, lung volumes are increased. Preliminary data in patients undergoing breast radiation as well as lung radiation has demonstrated the safety and feasibility of such an approach, demonstrating increased lung volumes with decreases in heart dose6-8. Additional potential advantages of CPAP include increased ease of use for patients and the potential for cost savings as compared to traditional respiratory management techniques.

This prospective study is to allow for the collection and assessment of data on patients with left-sided breast cancer or undergoing lung SBRT utilizing CPAP. This will allow for the assessment of lung doses with and without CPAP as well as cardiac doses. No additional changes to our standard of care breast or lung radiation will occur. With respect to the safety profile, CPAP is commonly used with limited toxicity concerns. The potential benefit of CPAP has reduced lung and heart doses and, consequently, radiation-related toxicities.

Eligibility Criteria:
Inclusion Criteria:

* Patients with left-sided breast cancers

  * Patients must be undergoing left breast/chest wall radiation with or without regional nodal irradiation
* Patients undergoing lung SBRT

  * Primary lung cancers
  * Metastatic lung tumors

Exclusion Criteria:

* Patients with right side breast cancer
* Patients who are unable to tolerate the CPAP device
Incidence and Risk Factor of Post-ERCP Pancreatitis in Chronic Pancreatitis

The purpose of this study is to compare the incidence of post-ERCP pancreatitis (PEP) in chronic pancreatitis (CP) patients to that in biliary disease patients, to determine whether CP patients in early clinical stage have a higher PEP incidence, and to identify the predictive and protective factors for PEP in chronic pancreatitis patients.

Analysis of patients with chronic pancreatitis (CP group) and biliary disease (BD group) in Changhai Hospital from January 2011 to May 2015 were conducted. Difference of PEP incidences between BD group and CP group, as well as between M-ANNHEIM subcategories were calculated by chi-square test or Fisher's exact test. The predictive and protective factors for PEP were investigated by univariate and multivariate analysis.

Eligibility Criteria:
Inclusion Criteria:

* patients with an endoscope inserted to cannulate the pancreatic/biliary duct were included.

Exclusion Criteria:

* patients in whom the papilla of Vater was not reached;
* patients who underwent stent removal procedures without ductal cannulation;
* patients in whom the intubation was failed.
School-Based Tele-Physiatry Assistance for Rehabilitative and Therapeutic Services

Using a randomized trial design, the goal of this project is to prospectively compare outcomes from a telemedicine-based model of care to two cohorts: patients who receive in-person pediatric physiatrist medical direction (the "gold standard"), and those who receive medical oversight from non-specialist community providers. This project will determine the impact of this new model of care using telemedicine on parent/guardian satisfaction, adherence rates to an evidence-based hip surveillance program, and economic efficiency.

During this study, a novel model of care will be developed and tested using telehealth technologies to bring necessary medical expertise to children with special health care needs living in rural and underserved communities. This model of care will be implemented in eight school-based Medical Therapy Units (MTUs) in northern California using a randomized design. The investigators hypothesize that this model of care will result in 1) equal satisfaction of the care received in-person from pediatric physiatrists and increased satisfaction of the care received from non-pediatric specialists; 2) equal adherence rates to an evidence-based hip surveillance program when compared to children who receive care from in-person pediatric physiatry care and better adherence than children who receive care from non-pediatric specialists; and 3) cost savings when compared to medical direction provided in-person by pediatric physiatrists and non-pediatric specialist providers.

The first 6 months of the project will be a "ramp-up" period during which the protocol will be re-reviewed during MTU site visits and necessary contracts and approvals will be in place. The last 6 months will be reserved for data analysis, study closeout, and manuscript preparation. The intervention phase will include various designs of implementation. For those schools currently without pediatric physiatry services, the investigators will provide MTU services using telemedicine and add in-person clinics. For those schools where medical direction is provided by non-pediatric physiatrists, the investigators will augment current services using telemedicine to provide medical direction to some children using pediatric physiatrists. For those schools where pediatric physiatrists travel long distances to provide medical direction during scheduled clinics, the investigators will similarly add additional telemedicine services such that an augmented mixed model of in-person and telemedicine pediatric physiatrist medical direction will be provided.

Eligibility Criteria:
Inclusion Criteria:

* Participants will include children with special health care needs enrolled in the CCS Medical Therapy Program receiving care at one of the participating sites during the study period.

Exclusion Criteria:

* Children with special health care needs not enrolled in the CCS Medical Therapy Program.
Suprasorb® A + Ag in the Treatment of Wounds at Risk of Infection and Infected Wounds

The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Suprasorb® A + Ag wound dressing and rope, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated with use of Suprasorb® A + Ag wound dressing and rope within the certified indications and under the conditions of routine use.

This clinical investigation will be conducted as 3 weeks, multicentre, open, single-arm cohort study on patients presenting wounds at risk of infection or infected wounds. All wounds of the included patients will be treated with Suprasorb® A +Ag Antimicrobial Calcium Alginate Wound Dressings (and Suprasorb® A + Ag Antimicrobial Calcium Packing Rope - if required by the depth of the wound).

At inclusion visit (V1, day 0), interim visit (V2, after 10 days ±3 days) and termination visit (V3 after 21 days ±3 days or earlier; as soon as the wound is epithelialized completely) patients will have clinical examination and wound area measurements.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient is legally capable
* Presence of a heavily exuding wound
* Presence of one of the following wounds:

  * pressure ulcers
  * arterial ulcers
  * venous lower leg ulcers
  * diabetic ulcers OR
  * postoperative wound
  * skin graft and donor sites
* Infected wound (TILI Score ≥ 5) or a wound with risk of infection (W.A.R. Score ≥ 3)
* Wound area between 4 and 100 cm2
* It must be possible to display the entire wound area on one photo from a distance of 25-30 cm
* Patient has signed a written Informed Consent

Exclusion Criteria:

* Treatment with Suprasorb® A + Ag Antimicrobial Calcium Algi-nate Wound Dressing and Rope or any silver containing dressing or topical drug during the last 3 weeks
* Known sensitivity to Suprasorb® A + Ag Antimicrobial Calcium Alginate Wound Dressing and Rope or any of their components
* Malignant wounds (tumor related wounds)
* Critical limb ischemia
* Infected wounds requiring systemic antibiotic therapy at baseline visit or infected wounds with surrounding skin requiring local an-tibiotics at baseline visit and/or during study conduct.
* Severe sensitive neuropathy (9-10 points on the Neuropathie-Symptom-Score (Diagnose und Therapie der sensomotorischen diabetischen Neuropathien. Diabetes und Stoffwechsel, 11, Suppl.2 (2002))
* Planned amputation within the next 1 months
* A planned surgical operation in the region of the study wound within the next 4 weeks following inclusion
* Patient is not compliant regarding treatment of the underlying disease (e.g. compression)
* Dry wound
* Pregnancy or breast feeding
* Reliable severe malnutrition
* Patient is analphabet
* Participation in any clinical trial within the last 1 month and during participation in this study
* Legal incapacity
Tongue Morphology and Posterior Airway Space as Predictors of Response in Patientswith Hypoglossal Nerve Stimulation Therapy

Hypoglossal nerve stimulation (HNS) plays an increasingly important role in managing patients with obstructive sleep apnea (OSA) who do not tolerate CPAP therapy and are not eligible for other alternative treatment options, such as mandibular advancement devices or positional therapy. The posterior upper airway space dimensions are crucial in managing patients with HNS in the patient selection process and therapy control. The lateral collapse of the upper airway is of crucial importance. Lateral collapse at the palatal level and of the oropharyngeal walls is a well-established negative predictive factor for therapeutic success. Patients with complete concentric collapse at the palatal level (pCCC) in drug-induced sedation endoscopy (DISE) must be excluded from the implantation of HNS, which is cumbersome and invasive. Endoscopy has the inherent limitation that only one level can be observed at a given time, and assessment is possibly hampered by phlegm.

During activation and titration of HNS, tongue protrusion is observed in the awake patient. However, this method does not allow for assessing the opening of the retroglossal (RG) and retropalatal (RP) airway space, which is the ultimate therapeutic goal. Insufficient opening of the airway is the reason for non-responders with HNS. Insufficient upper airway opening can be either at the retropalatal or retroglossal level. The study aims to identify insufficient airway openings better using sub-mental ultrasonography. Sub-mental standardized and orientated ultrasonography offers a quantitative, reproducible way of assessing transverse upper airway dimensions and anatomic features of the upper airway in a rapid and non-invasive manner. In addition, anatomic characteristics of the airway's adjacent tissue, such as the size and shape of the tongue, may also have an impact on the effectiveness of HNS. Tongue morphology and posterior airway space assessment could be used in preoperative evaluation and during therapeutic titration of HNS. The clinical routine could be included tongue morphology and posterior airway space assessment without additional patient risks. However, the clinical value of assessing posterior airway space and tongue morphology in patients with HNS is yet unknown.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 year
* patients with a hypoglossal nerve implantation
* control group: 15 subjects without OSA (AHI\<10/h)
* written informed consent
* sufficient knowledge of German or French to understand informed consent

Exclusion Criteria:

* Patients younger than 18 years
* unwillingness to give informed consent
* incapable of performing Müller's maneuver
* history of head and neck surgery other than HNS, tonsillectomy, and maxillomandibular advancement
* diagnosis of congestive heart failure or chronic pulmonary disease
* diagnosis of co-morbid sleep disorders, including central sleep apnea
* pregnancy
MOON Shoulder Instability-Cohort of Patients Undergoing Operative Treatment.

This project will be a multi-center, prospective longitudinal cohort for all patients undergoing primary shoulder instability surgery, excluding isolated SLAP repairs. We will be looking for risk factors for recurrent instability, revision surgery, and poor outcomes. Patients will be asked to complete the RAND-36, ASES, Shoulder Activity, EQ-5D and WOSI outcome measures, as well as demographic and socioeconomic information. Surgeons will complete a form after surgery with information on radiographic findings, physical exam, surgical findings, and the repair. Patients will wear a sling post-operatively, and follow standardized rehabilitation protocols, including physical therapy.

Patients will be sent outcome questionnaires at 2, 6, 10, and 20 years after surgery.

The objective of this prospective multicenter cohort study of patients undergoing surgery for glenohumeral instability is to identify the outcomes, and more importantly, the previously unknown predictors of sports function, activity level, general health, recurrent instability symptoms, and surgical failures following surgery. Patient information at the time of the surgery (demographics, validated outcome measures), in addition to the physical exam findings, shoulder pathology at the time of surgery, and surgical treatment will be obtained. The validated outcome instruments are American Shoulder and Elbow Surgeons Score, Western Ontario Shoulder Instability, Kerlan Jobe Overhand Athlete Score, Shoulder Activity Score, and RAND-36. Post-operative physical exam data will be obtained at 6 months after surgery. Patient reported outcomes will be repeated at 2, 6, 10, and 20 years post-operatively. Our multivariable analysis will identify which of the many factors related to the injury, intra-operative treatment, postoperative care, physical patient characteristics, and behavioral patient characteristics contribute to recurrence and poor outcome.

Eligibility Criteria:
Inclusion Criteria:

This is a prospective cohort study; there is no control group. Subjects that are included are all patients undergoing surgery for shoulder instability.

Inclusion criteria:

* Anterior, posterior, and inferior instability
* Ages 12-99
* Open and arthroscopic repair
* Revision of a previous shoulder instability repair
* Latarjet/bone augmentation

Exclusion Criteria:

* Workers compensation patients
* Prisoners
* Non-English speaker
* Not mentally competent
* Unable/unwilling to return for clinical follow-up
* Arthroplasty patients
* Rotator cuff tears
* Fractures