cyrilzakka/clinical-trials huggingface dataset:
A Study of Tazemetostat in Combination With HMPL-689 in Patients With Relapsed/Refractory Lymphoma

A phase II clinical study of tazemetostat combined with HMPL-689 in patients with R/R lymphoma. The study includes 2 phases: dose escalation phase (phase IIa) and expansion phase (phase IIb).

Dose Escalation Phase (Phase IIa ):Including 10-20 patients for dose escalation, the enrollment will continue until about 10 patients in the dose group with response, as to determine Recommended Phase II dose (RP2D).

Dose Expansion Phase (Phase IIb):Multiple expansion cohorts will be set up according to different tumor types, and about 15-20 patients will be enrolled in each cohort to further observe the anti-tumor effect of Tazemetostat combined with HMPL-689 in different pathological types of R/R lymphoma.

This study is expected to enroll 85-140 patients total in Phase IIa and phase IIb.

Eligibility Criteria:
Criteria: Inclusion Criteria:

1. Willing and able to give informed consent, as documented by signed ICF
2. Age ≥ 18 years
3. Patients with histologically confirmed R/R lymphoma:

   • Phase IIa （dose escalation study）: patients with relapsed or refractory lymphoma who have failed standard treatment and have no standard treatment options

   • Phase IIb（ expansion Study ）: Cohort 1 (DLBCL, FL 3b) Histologically confirmed DLBCL, FL 3b (including primary mediastinal B-cell lymphoma) with relapsed/refractory disease

   Cohort 2 (FL) patients with histologically confirmed R/R FL (Grade 1, 2, 3a)

   Cohort 3 (MCL): Patients with R/R MCL who had prior therapies

   Cohort 4 (PTCL): Patients with histologically confirmed R/R PTCL who have failed or cannot tolerate standard therapy
4. Patients must have at least one measurable lesion
5. Life expectancy ≥ 12 weeks
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
7. Adequate bone marrow function, renal function and hepatic function:
8. Currently human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or cytomegalovirus (CMV) is inactive
9. Female patients of childbearing potential must agree to use a double contraception method and male patients with partners of childbearing potential must also use an effective double contraception method during the study period and for 3 months after the final dose

Exclusion Criteria:

1. Patients who have previously used EZH2 inhibitors and PI3K inhibitors, or previously could not tolerate EZH2 inhibitors or PI3K inhibitors
2. Patients with brain metastases or leptomeningeal invasion
3. Has thrombocytopenia, neutropenia, or anemia of Grade ≥3 (per CTCAE 5.0 criteria) and any prior history of myeloid malignancies, including myelodysplastic syndrome (MDS / AML/MPN)
4. Has abnormalities known to be associated with MDS (e.g. del 5q, chr 7 abn) and multiple primary neoplasms (MPN) (e.g. JAK2 V617F) observed in cytogenetic testing and DNA sequencing
Positive Changes in Quality of Life of Older Cancer Patients and Their Caregivers

RATIONALE: Gathering information about the positive changes in quality of life of older patients with cancer and their care givers may help doctors learn more about the disease and plan better treatment.

PURPOSE: This research study is looking at positive changes in the quality of life of older cancer patients and their caregivers.

OBJECTIVES:

Primary

* To use prior data from an existing registry (Quality of Life Survey Registry for Persons With Cancer and Family Caregivers protocol CASE-8Z05) and to expand upon these data by adding measures that capture the particularly salient concepts of the patient/caregiver dyadic relationship and posttraumatic growth.
* To identify rates and psychosocial correlates of posttraumatic growth among older adult cancer patient/spouse or partner dyads.

OUTLINE: Patients and their caregivers complete three questionnaires that will take approximately 20 minutes either by mail or telephone. The questionnaires comprise of demographic and psychosocial correlates of posttraumatic growth including age, ethnicity, socioeconomic status, education, anxiety, relationship quality, coping style, social support, and cultural beliefs about caring for elders.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Patient must meet the following criteria:

  * Confirmed cancer of any type
  * Currently receiving medical care at the Ireland Cancer Center at University Hospitals of Cleveland
  * Must have enrolled and participated in CASE-8Z05
* Identified available family caregiver of a patient diagnosed with stage III or IV cancer

PATIENT CHARACTERISTICS:

* Patients must meet the following criteria:

  * ECOG performance status 0-3
  * Cognitively competent to be interviewed
  * Able to speak and comprehend English
* Caregivers must be able to speak and comprehend English

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Evaluation of Fluid Resuscitation in Children With Cancer With Severe Sepsis / Septic Shock

Retrospective study to evaluate the characteristics of patients and of fluid resuscitation during intensive care unit hospitalization of patients under septic chock.


Eligibility Criteria:
Inclusion Criteria:

* patients admitted between Jan/2009 and Dec/2010
* patients with septic chock diagnosis

Exclusion Criteria:

-
Visual Function After Implantation of Bilateral AcrySof ReSTOR Aspheric +3

A prospective evaluation of the visual parameters in a series of patients bilaterally implanted with AcrySof ReSTOR +3 Intraocular Lens (IOL).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cataracts

Exclusion Criteria:

* Pre-existing conditions that could skew the results or are contraindications for the ReSTOR intraocular lens;
* \<1 diopter astigmatism by keratometry readings.
Developing a Telehealth Model to Improve Treatment Access for Rural Veterans With Substance Use Disorders

This project will pilot-test and obtain stakeholder input on a telehealth-delivered substance use disorder (SUD) care model (with initial engagement and ongoing MI-CBT treatment) with the goal of increasing treatment utilization and improving outcomes for rural and non-rural Veterans with SUDs.


Eligibility Criteria:
Inclusion Criteria:

* Veteran patients at the Ann Arbor VA Healthcare System
* Diagnostic and Statistical Manual of Mental Disorders (DSM-5) SUD diagnosis and/or substance use on average of 2 days a week over the past month
* Telephone access
* Able to provide informed consent

Exclusion Criteria:

* Receiving SUD psychotherapy
* Inability to speak or understand English
* Substantial mental health instability or conditions that preclude informed consent (e.g., acute psychosis, cognitive deficits) or understanding of assessment or program content
* Prior alcohol withdrawal seizures or delirium tremens
A Cohort Study on the Safety of Laparoscopic Resection of 5cm or Larger Gastric Gastrointestinal Stromal Tumors

The purpose of this study is to explore the safety of laparoscopic resection of 5cm or larger gastric gastrointestinal stromal tumors

There is a lack of high-quality evidence on the efficacy and safety of laparoscopic resection of gastric GIST over 5cm. A multicenter, prospective cohort study was conducted to evaluate the clinical efficacy of laparoscopic resection of 5cm or larger gastric gastrointestinal stromal tumors (GIST) compared to laparoscopic resection of GIST of less than 5cm. The primary evaluation parameter is overall postoperative morbidity.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years \< age \< 75 years
2. Primary gastric lesion diagnosed as gastric GSIT by endoscopic biopsy histopathology or suspected gastric GIST by preoperative endoscopy, ultrasound endoscopy, or CT or MR, and confirmed as primary gastric GIST by postoperative pathology
3. Patient informed consent and willingness to undergo laparoscopic resection
4. Expected laparoscopic outcome of R0 resection
5. Performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2, Preoperative American Society of Anesthesiologists（ASA） score I-III

Exclusion Criteria:

1. Women during pregnancy or breast-feeding
2. Severe mental disorder
3. History of upper abdominal surgery (except the history of laparoscopic cholecystectomy)
4. History of gastric surgery (except ESD/EMR for gastric cancer)
5. History of other malignant diseases within the past five years
6. History of unstable angina or myocardial infarction within the past six months
7. History of a cerebrovascular accident within the past six months
8. History of continuous systematic administration of corticosteroids within one month
9. Requirement of simultaneous surgery for other diseases
10. Emergency surgery due to complications (bleeding, obstruction, or perforation) caused by gastric cancer
Ultrasonographic Assessment of Stomach in Two Different Fasting Guidelines

Oral carbohydrate loading until 2 h before surgery is well known to be effective in facilitating postoperative recovery and reducing complications, by maintaining homeostasis. However, there are still concerns in implementing this as a universal fasting guideline, because of the risk of pulmonary aspiration. Therefore, we designed this study to compare the two preoperative fasting guideline: (1) keep fasted from midnight until surgery, and (2) oral carbohydrate beverage 800 mL from midnight until 2 h before surgery.


Eligibility Criteria:
Inclusion Criteria:

* adult aged from 18 to 70
* American Society of Anesthesiologists (ASA) class I or II
* absence of pregnancy
* not on lactation at the time of surgery

Exclusion Criteria:

* delayed gastric emptying (GERD, gastrointestinal disease, diabetes)
* contraindicated to NSAID or opioid
* mental disorders
* alcoholism
* drug abuse
Longitudinal Assessment of Bariatric Surgery Sub-Study

The goal of this project is to examine the physical mechanisms that contribute to improvements of glucose tolerance in type 2 diabetes mellitus (DM) following certain types of bariatric surgery.

The goal of this project is to examine the physiological mechanisms that contribute to improvements of glucose homeostasis in type 2 diabetes mellitus (DM) following gastric bypass Roux-en-Y bariatric surgery (GBP). The central hypotheses are: 1) that surgical changes in the anatomy of nutrient absorption achieved by GBP change incretin hormone secretion which in turn improves pancreatic islet function; and 2) that improvement in insulin secretion induced by the changes in incretin function, together with improvement in insulin resistance induced by weight loss, normalize glucose homeostasis in type 2 DM.

Funds are not available to pay for the surgery for patients, only to address research questions.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are at least 18 years of age and undergo bariatric surgery by a LABS certified surgeon.
* Enrollment in LABS-1 or LABS-2.
* Documented type 2 diabetes (fasting plasma glucose greater than 125 mg/dl) that is treated with lifestyle efforts (drug naïve) or taking acceptable oral medications (see appendix) with a HgA1c less than or equal to 8.5% and a fasting blood glucose less than or equal to 180 mg/dL. This will be one group.
* Non-diabetic (ND) with normal values for fasting glucose and HbA1c. This will be the second group.
* Adequate IV access.

Exclusion Criteria:

* Informed consent not obtained.
* Patient with diabetes with an HbA1c greater than 8.5% or a fasting blood glucose greater than 180 mg/dL.
* Creatinine greater than 1.7.
* Unlikely to comply with the 6 month follow-up (post-surgical) protocol (i.e. geographically inaccessible for study visits) or unable to communicate with local study staff.
* Use of unacceptable diabetic medications (see appendix) at baseline (see appendix).
Data Collection Protocol for the Development of CHLOE-OQ, an AI Model for Assessing Oocytes Quality.

This data collection protocol is aimed to allow the reliable and robust development (training, verification, and validations) of CHLOE technology-based applications as well as improve the machine learning stage of released devices/applications. Additionally, a simulated use assessments will be conducted to ensure the correct and easy use of the CHLOE applications.

The CHLOE-OQ Data Collection Protocol is designed to support the reliable and robust development of the CHLOE technology-based application, ensuring their accuracy and effectiveness in assessing oocyte quality. This protocol facilitates the entire AI model development lifecycle, including training, verification, and validation, to enhance the performance and reliability of machine learning algorithms integrated into the CHLOE application.

Additionally, the protocol aims to refine the machine learning stage of the already released OQ applications by incorporating new data and improving model performance over time. A key component of this process includes simulated use assessments, which are conducted to evaluate the usability, accuracy, and overall functionality of CHLOE applications in real-world clinical settings by means of a questionnaire for embryologist using CHLOE. These assessments ensure that the technology is not only scientifically sound but also user-friendly, making it easier for embryologists to integrate CHLOE applications into their workflow efficiently.

By adhering to this structured data collection protocol, the CHLOE application can continuously evolve, maintaining high standards of performance and usability in the assessment of oocyte quality.

Eligibility Criteria:
Inclusion Criteria:

* Women at least 18 years of age.
* Embryos or eggs cultured in a time-lapse incubator connected to CHLOE Embryo Viewer.

Exclusion Criteria:

* Women with autologous eggs
Bleb Vascularity Change After Subconjunctival Injection Bevacizumab

The occurrence of conjunctival scarring finally leads to the obstruction of the fistula tract created by the filtering surgery. Vascular endothelial growth factor is thought to be a key role in the formation of conjunctival scar, which play a pivotal role in the wound-healing process. So it seems that the recombinant human anti-VEGF antibody could inhibit angiogenesis, and reduce the conjunctival vascular formation in the wound-healing process after glaucoma filtering surgery.


Eligibility Criteria:
Inclusion Criteria:

* Glaucoma patients after trabeculectomy whose bleb is hyperaemia

Exclusion Criteria:

* Affected eye has normal IOP
* Not allergic with Avastin
Body Weight and Carb Metabolism

Whilst theoretically, body size should influence the capacity for intestinal carbohydrate absorption and thus exogenous oxidation rates during exercise, there is currently little empirical evidence to support this hypothesis. Accordingly, current nutrition guidelines for carbohydrate intake during exercise do not take body mass into account. Therefore, there is a need to establish whether body mass is related to exogenous carbohydrate oxidation rates during exercise. If such a relationship is established, this would lay the foundation to revise the current sports nutrition guidelines regarding carbohydrate intake during exercise.

The aims of this study are, therefore, to: 1) establish whether larger individuals display higher rates of exogenous carbohydrate oxidation than smaller individuals; and 2) establish if such a difference can be explained by the higher absolute exercise intensity, and thus the energy demand of exercise. It is hypothesised that larger individuals will demonstrate higher exogenous carbohydrate oxidation rates than smaller individuals, and that this difference will be partly (but not completely) diminished when the absolute intensity of exercise is matched.


Eligibility Criteria:
Inclusion Criteria:

* Able to cycle continuously for 2 hours at a moderate intensity
* VO2max of between 40-75 mL/kg/min
* Fat-mass index (determined by dual energy x-ray absorptiometry) \< 5.5 kg·m-2

Exclusion Criteria:

* Diagnosed disorders of the gastrointestinal tract (e.g. crohn's, colitis etc.)
* People following a low-carbohydrate, high-fat diet
* Pregnant or lactating
* Diagnosed cardiovascular disease
* Possible symptoms of cardiovascular disease
* Diagnosis of diabetes of any type
* Hypercholesterolaemia (total cholesterol ≥ 6.2 mmol/L
* Hypertension (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg)
* Current smoker
* Family history of coronary artery disease (first-degree relative \<60 years)
* Prevalence of vascular disease
* Autonomic neuropathy
* Kidney disease
* Diagnosed pulmonary disease (e.g. chronic obstructive pulmonary disease, asthma, interstitial lung disease or cystic fibrosis)
* Blood borne disease or infection
* Osteoporosis
* Osteoarthritis
* Blood clotting disorders
* Food intolerances/allergies (these may not specifically exclude you- please talk to the investigator)
* Sensitivity or allergy to anaesthetic
A Multi-Center Study Of CD07743 for the Improvement of Lateral Canthal Lines (CROW'S FEET)

This double-blind study has two parts for each subject (same population):

Part A: initial treatment in Lateral Canthal Lines (LCL) (placebo-controlled):

* To assess the efficacy and safety of Azzalure® compared to placebo in the improvement of moderate to severe LCLs.
* To assess the subjects' level of satisfaction with the appearance of their LCLs compared to placebo.

Part B: repeated treatment in LCL with or without Glabellar Lines (GL) (active treatment, up to 1 year):

* To assess safety of Azzalure® following repeated administration in the improvement of moderate to severe LCLs.
* To assess the safety of Azzalure® when used concomitantly for improvement of moderate to severe LCLs and GLs.
* To assess the subjects' level of satisfaction with the appearance of their LCLs.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects, 18 to 65 years of age (Screening visit),
* Moderate or severe (grade 2 or 3, Hund 2006) Lateral Canthal Lines "at maximum smile" determined by investigator at screening and baseline
* Mild to severe (grade 1, 2 or 3, Hund 2006) Lateral Canthal Lines "at rest" determined by investigator at screening and baseline
* The subject is a female of childbearing potential and has a negative urine pregnancy test (UPT) at screening and baseline
* Subjects who are not satisfied with their appearance at screening and baseline
* The subject is willing and able to comply with the requirements of the protocol and agree to adhere to the visit schedule, concomitant therapy prohibitions and must be compliant to the study instruction.
* The subject agrees to participate in the study, verified by dating and signing an approved written Informed Consent Form (ICF) and Photography Consent Form (PCF) (selected sites only if applicable) at the enrolment visit before any study procedures at screening

Exclusion Criteria:

* Any prior surgery affecting the orbicularis oculi muscle, prior blepharoplasty or brow lift, or any prior cosmetic procedures or scars that may interfere with the evaluation of the investigator.
* Previous insertion of any permanent, semi-permanent or biodegradable material in the periorbital region or facial treatment with augmentation material (e.g. silicon injections, collagen type implants, hyaluronic acid, lactic acid, etc.) within 12 months prior to screening.
* Any prior treatment with botulinum toxin (of any serotype)
* Previous treatment with lasers for skin resurfacing (e.g. CO2 (carbon dioxide)-laser) or treatment with deep chemical peels and any other esthetic or dermatologic treatments or procedures in any area of the face within 12 months prior to screening.
* Any planned facial cosmetic surgery or procedures during the study period.
* Presence of any bleeding disorders
* Pregnant or lactating women or women who are planning pregnancy during the study.
* Known hypersensitivity to any of the test materials or related compounds.
Comparative Clinical Trial of Efficacy and Safety of BCD-055 and Remicade® in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis

BCD-055-3 is international multi-center comparative double-blind randomized clinical trial of efficacy and safety of BCD-055 (JSC "BIOCAD", Russia) and Remicade® in combination with methotrexate in patients with active rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Active rheumatoid arthritis according to criteria of American College of Rheumatologists (2010), that was diagnosed at least 6 months prior to screening.
* Active rheumatoid arthritis at screening despite of therapy with methotrexate for 3 last months.
* Use of methotrexate in stable dose for at least 4 weeks before screening (10-25 mg per week).
* History of ineffective treatment with basic antiinflammatory drugs (including methotrexate).

Exclusion Criteria:

* Previous therapy of rheumatoid arthritis with monoclonal antibodies (including anti-tumor necrosis factor drugs)
* Felty's syndrome
* Functional status - class IV according to ACR classification (1991)
* Low activity of rheumatoid arthritis (DAS28-CRP(4) index less than 3.2)
* Patient needs corticosteroids in a dose more than 10 mg (recalculated to prednisolone) before signing informed consent.
* Patients needs equal of less than 10 mg prednisolone but the dose was not stable for last 4 weeks prior to infliximab treatment
* Prior use of disease-modifying antirheumatic drugs including methotrexate, sulfasalazin, chloroquine or hydroxychloroquine for up to 4 weeks before randomization.
* Prior use of alkylating agents for up to 12 months prior to signing informed consent.
* Intraarticular use of corticosteroids for up to 4 weeks before randomization.
* Prior use of live or attenuated vaccines for up to 8 weeks before signing informed consent.
* Diagnosis of tuberculosis.
* Body mass more than 130 kg.
Group B Streptococcus (GBS) Associated Stillbirths in a High Burden Setting

This is a descriptive study to determine the role of fetal GBS disease as a cause for stillbirths

A prospective, descriptive study will be undertaken involving mothers who have a stillbirth at Chris Hani Baragwanath Academic Hospital (CHBAH), a secondary-tertiary care hospital, from 2014 up until 2016.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women delivering a stillbirth at CHBAH
* Participants aged ≥18 years
* Able to understand and comply with planned study procedures
* Provides written informed consent (either generic ICF or V98_28OBTP)

Exclusion Criteria:

* Refuses to consent to study participation