cyrilzakka/clinical-trials huggingface dataset:
A Study of Intratumoral KL340399 in Patients with Advanced Solid Tumors

This is a single center, open-label, dose increasing study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and antitumor efficacy of KL340399 intratumoral in patients with advanced solid tumors.

This is a single center, open-label, dose increasing study to evaluate the safety, tolerability, pharmacokinetic(PK) profile, and antitumor efficacy of KL340399 intratumoral in patients with advanced solid tumors.The dose increasing method of "BLRM" is used to explore the safety, tolerance and determine the maximum tolerated dose(MTD).

Eligibility Criteria:
Inclusion Criteria:

1. Patient is at least ≥18 years of age (male or female);
2. Patients with histologically and/or cytologically confirmed advanced solid tumors who have failed standard of care, or who have no available standard of care regimen, or who are unqualified for standard of care. Presence of at least one measurable lesion for intratumoral ;
3. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1, estimated survival ≥ 3 months;
4. Adequate organ and bone marrow function (no blood components and cytokines are allowed within 14 days prior to the first dose) ;
5. More than 4 weeks from the last radiotherapy, chemotherapy, surgery, hormone treatment, target therapy, and toxicity from previous antitumor therapy returned to baseline or CTCAE≤ grade 1;
6. Patients of childbearing potential (male or female) must use effective medical contraception during the study and for 3 months after the end of dosing;
7. Patients voluntarily participate in the study, sign the ICF, and will be able to comply with the protocol-specified visits and relevant procedures.

Exclusion Criteria:

1. Known history of severe allergies, or allergy to any component of KL340399;
2. Received any previous therapy of STING-activating, or received any immunostimulant therapy within 28 days;
3. Have other malignancies within 5 years;
4. Concomitant or known metastases to brain or central nervous system;
5. Active autoimmune disease;
6. History of major cardiovascular diseases;
7. Uncontrolled systemic diseases;
8. Known of coagulation disorders, hemorrhagic disease;
9. Confirmed serious lung disease or lung disease;
10. Subjects with third space fluid that can not be controled by drainage or other methods;
11. Known active infection;
12. Known HIV, active hepatitis B/C virus;
13. Pregnant or lactating women;
14. Received immunotherapy and had immune related adverse reactions ≥ grade 3;
15. Have received stem cell transplantation or organ transplantation;
16. Receive any live or attenuated live vaccine within 4 weeks;
17. History of serious dementia, altered mental status, or any psychiatric disorder;
18. Evidence of alcohol or drug abuse;
19. Participated in any other clinical trials and received treatment within 4 weeks;
20. Have other factors based on which the investigator considers that the subjects are not appropriate to participate in the study.
Post-Treatment Surveillance in Breast Cancer: Bringing CER to the Alliance

Nearly three million living women have survived breast cancer. Physicians rely on clinical practice guidelines to make decisions on follow-up care. Among other things, the goal is to monitor for recurrence or side effects of treatment among survivors. It is unclear whether these guidelines represent the best approach for any given patient as they do not account for differences in disease or patient preferences and may not consider recent advances in imaging and treatment options. We seek to develop a new approach to surveillance following breast cancer treatment which will be more patient-centered and effective than the existing one-size-fits-all approach and will consider individual risk factors.

Our project involves three primary goals:

1. Use existing data from clinical trials sponsored by one of the leading cancer cooperative groups to evaluate how risk of recurrence and side effects of treatment vary based on patient and cancer characteristics.
2. Use existing data to evaluate the effectiveness of the latest imaging technology for improving survival in patients previously treated for breast cancer.
3. Engage cancer survivors, providers, and health outcomes researchers in the development of an improved patient-centered approach to guide post-treatment care, as well as identification of the highest priority strategies for prospective randomized trials.

Methods Our methods have been developed based on input from patients and other stakeholders who identified the need for a large-scale observational study. The goal is to produce timely results, and guide the development of an improved approach to surveillance that recognizes individual patient risk factors and allows for design of future prospective studies. This study analyzes recurrence data and treatment side effects on over 22,000 patients involved in past clinical trials on breast cancer care. The project also involves the analysis of existing data (n=15,000 patients) from a national cancer registry (National Cancer Database) to evaluate whether new imaging technology, beyond mammography, are able to detect recurrence earlier and improve survival. Finally, we will engage cancer survivors, health care providers, and researchers to develop new guidance for the care and monitoring of breast cancer survivors, and to guide and prioritize future prospective trials.

Eligibility Criteria:
Inclusion Criteria:

* Women (all Aims)
* Diagnosis of breast cancer (Aims 1 \& 2)
* American Joint Committee on Cancer (AJCC) stages I-III (Aim 1) AJCC stages II-III (Aim 2)
* Patient, health care provider, and researcher stakeholders (Aim 3)

Exclusion Criteria:

* None
Long-term Follow-up of Subjects With Transfusion-Dependent β-Thalassemia (TDT) Treated With Ex Vivo Gene Therapy

This is a multi-center, long-term safety and efficacy follow-up study for subjects with transfusion-dependent β-thalassemia (TDT) who have been treated with ex vivo gene therapy drug product in bluebird bio-sponsored parent clinical studies. After completing the parent clinical studies (approximately 2 years), eligible subjects will be followed for an additional 13 years for a total of 15 years post-drug product infusion. No investigational drug product will be administered in this study.


Eligibility Criteria:
Inclusion Criteria:

* Provision of written informed consent for this study by subjects, or as applicable, subject's parent(s)/legal guardian(s)
* Treated with drug product for therapy of transfusion-dependent β-thalassemia in a bluebird bio-sponsored clinical study

Exclusion Criteria:

* There are no exclusion criteria for this study
Gadofosveset Trisodium (Ablavar, Gdfos) in Distinguishing Hemangiomas and Metastases: A Prospective Trial

The purpose of this study is to determine if Gadofosveset Trisodium (Gdfos, Ablavar) is a useful magnetic resonance imaging (MRI) contrast agent in accurately diagnosing liver metastases compared to the standard agent gadobutrol (EcGd, Gadovist).

The proposed study will be a single centre, prospective trial comparing the sensitivity and specificity of using Gadofosveset Trisodium (Gdfos, Ablavar) as the MRI contrast agent as compared to gadobutrol (EcGd, Gadovist).

The study population will include cancer patient's referred for an MRI study of the liver to rule out metastases. Those who meet the inclusion/exclusion criteria will their routine (clinical) MRI of the liver with EcGd. They will also receive an additional MRI with Gdfos within 4 weeks of the original study.

The patient data will be anonymized and the imaging will be read by radiologists and radiology residents and comparison will be made between the diagnostic accuracy of the EcGd-enhanced study and the Gdfos-enhanced study.

Eligibility Criteria:
Inclusion Criteria:

* known cancer
* referred for MRI of liver to rule out metastases
* has focal liver lesions
* age \> 18 yo

Exclusion Criteria:

* contraindication to MRI or MR contrast agents
* pregnancy
* unable to obtain all sequences and/or acceptable quality imaging
Ovarian Stimulation and Intrauterine Insemination in Women With Polycystic Ovarian Syndrome

The study null hypothethesis is: intrauterine insemination (IUI) does not improve pregnancy rates in women with polycystic ovary syndrome. Infertile women with pcos will receive gonadotropins for ovarian stimulation and then randomize to either IUI or timed intercourse (TI)


Eligibility Criteria:
Inclusion Criteria:

- women who failed to get pregnant after 6 ovulation induction cycles with clomiphene citrate (cc) alone, despite of being ovulating with cc, having patent Fallopian tubes as confirmed by hysterosalpingography and their partners had fertile semen parameters according to criteria of World Health Organization (WHO 2010)

Exclusion Criteria:

male factor infertility
Mycoprotein and Pea Protein Blend and Muscle Protein Synthetic Response

Dietary protein is vital for the preservation of health and optimal adaptation to training. Plant proteins are considered inferior to animal proteins with respect to their ability to stimulate an acute muscle building response and therefore support long-term muscle reconditioning. Pea protein is a highly commercially available plant proteins source (available as supplements, food ingredients etc.), yet there is no research investigating its ability to stimulate a muscle building response. The investigators aim to assess the effect of consuming pea protein on muscle protein synthesis rates and compare these results to mycoprotein, a source known to elicit a robust anabolic response.

Pea protein is lower in some of the essential amino acids, namely methionine, which could mean it is less effective compared with mycoprotein which has a more complete amino acid profile. So in addition to comparing pea with mycoprotein, the investigators also want to compare to a blend of pea and mycoprotein to see if replenishing the amino acid content in pea 'rescues' the anabolic response.


Eligibility Criteria:
Inclusion Criteria:

* BMI between 18 and 30
* Resistance trained

Exclusion Criteria:

* Any metabolic impairment
* Smoking
* Use of over the counter pharmaceuticals (excluding oral contraceptives and contraceptive devices).
* A personal family history of epilepsy, seizures or schizophrenia.
* Allergic to Quorn/mycoprotein/edible fungi/environmental mould products.
* Any motor disorder.
Trial of AD113 and Atomoxetine in OSA Patients With Hypertension

This is a randomized, double blind, 2-period, non placebo-controlled crossover study in patients with moderate to severe OSA and controlled hypertension, comparing atomoxetine with AD113

The study is designed to examine the efficacy and safety of AD113 to treat obstructive sleep apnea with hypertension. The study is a two-period multi-dose randomized crossover design in which patients will undergo overnight polysomnographic (PSG) testing with dosing of one of the following 2 treatments: AD113 for 10 days or Atomoxetine for 10 days. Participants will return 1 week after their final crossover PSG for an end of study (EOS) Visit.

Eligibility Criteria:
Inclusion Criteria:

* Between 25 to 65 years of age, inclusive, at the Screening Visit.
* AHI 10 to 50 (hypopneas defined by 4% oxygen desaturation)
* History of hypertension or blood pressure at Visit 1 ≥130/80 mmHg

Exclusion Criteria:

* History of narcolepsy.
* Clinically significant craniofacial malformation.
* Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. A medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication
* CPAP should not be used for at least 2 weeks prior to first study PSG
* History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.
HbA1c and Outcomes in the Critically Ill

Background: Glycated hemoglobin A1c (HbA1c) has been linked to poor outcomes in the cardiac surgery, septic and critically ill patient population. It is a promising test to understand the complex relationship between glycemia, diabetes and outcomes in patients admitted to the intensive care unit.

Hypothesis: An elevated HbA1c value on admission to an intensive care unit (ICU) is associated with poor outcomes.

Objectives: The primary objective of this study is to determine hospital mortality of all newcomers admitted to the ICU, and to compare it between patients with HbA1c \<6.5% and ≥6.5%. Other outcomes that will be measured include ICU and one year mortality, ICU and hospital length of stay (LOS), days on mechanical ventilation, serious infection during hospitalization and renal failure requiring dialysis during hospitalization and at 6 months. The investigators will also determine the prevalence of pre-diabetes (HbA1c 6.0-6.4%) and diabetes (≥6.5%) in the critically ill population based on HbA1c levels and monitor glucose control and insulin requirements during the first three days of ICU admission.

Methods: This project is a prospective observational study at the McGill University Health Center adult medical and surgical ICUs. HbA1c is measured at the admission to the ICU. The data are being collected prospectively using Microsoft access data entry. The following parameters will be recorded on admission: admitting diagnosis, sex, age, height, weight, body mass index (BMI), Acute Physiology and Chronic Health Evaluation (APACHE) II score, previous diagnosis of DM, whole blood HbA1c level, blood and plasma glucose levels. With power 80%, type I error 5% and with an expected 25% mortality difference between patients with HbA1c≥6.5 and \<6.5, the required sample size is 1800 patients. The data will be presented as mean ± SD unless otherwise specified and statistical significance will be set as P \< 0.05. All p-values presented will be 2-tailed.

Significance: The investigators want to demonstrate that HbA1c ≥6.5 on admission to an intensive care unit is associated with increased 6 month mortality and worse outcomes. The investigators will also determine the prevalence of pre-diabetes and diabetes in the critically ill based on HbA1c.

Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to an intensive care unit within 48 hours

Exclusion Criteria:

* Patients with known hemoglobinopathy(ies)
* Patients that have received ≥2 units of packed red blood cells 48 hours prior to HbA1c sampling
Computer-assisted Psychosocial Risk Assessment (CaPRA) for Refugee Health and Settlement

The purpose of this study was to examine preliminary effect of Computer-assisted Psychosocial Risk Assessment tool (CaPRA) among Afghan refugees visiting medical professionals (family physicians or nurse practitioners) at a Community Health Center. The investigators examined the tool's acceptability among patients and its impact on patient satisfaction and patient intention to visit a psychosocial counselor as a proxy of potential to integrate medical and social care.

The recent waves of refugees to Canada belong to regions of prolonged conflict and, thus arrive in compromised state of mental, physical, and social health. This complexity asks for provision of integrated medical and social care to newly arrived refugees. With this aim, a university-community initiative developed a Computer-assisted Psychosocial Risk Assessment tool (CaPRA) in Dari/Farsi for Afghan refugees. This innovative eHealth approach is first of its kind for Canadian refugees accessing primary care. In this model of care, patients complete an interactive multi-risk iPad computer survey in their own language before seeing the provider. The computer then generates individualized recommendation sheet for patients and a risk-report for providers at the point of care. The tool was developed through a collaborative process by working with Access Alliance Multicultural Health and Community Services and advisory board with community representatives.

Eligibility Criteria:
Inclusion Criteria:

* Afghan refugee patients
* Over 18 years of age
* Speak and read Dari /Farsi or English language
* Eligible for federal or provincial health care program
* Visiting a participating medical practitioner

Exclusion Criteria:

* Patient visiting a provider who has not consented for the study
* Patient accompanied by a family member for interpretation
* New patients
* Patients unable to receive study details due to logistical issue (e.g, no private room)
Family Check-Up Online

The goal of this clinical trial is to test the benefits of the Family Check-Up Online Program for parents of middle school students in Arizona. Participants will complete an online pre-survey, gain access to the online parenting program Family Check-Up, and have the option to meet with a coach to discuss the program. The participants will also complete a post-survey 3 months after enrollment.

The lingering impact of the COVID-19 pandemic has impacted families adversely in multiple ways, including economic stressors, mental health-related functioning, and social/familial functioning. Given the scale of the pandemic's impact on families with school-aged children, the implementation of effective family-focused programs that target core mechanisms of change with a broad range of benefits for parents and youth across diverse populations, and that can be brought to scale rapidly and with fidelity, represents critical public health goals.

Toward this end, this project is designed to further examine the efficacy of a web-based version of the universal Family Check-Up prevention program, which is an empirically-supported, parent-focused program designed to promote resilience and improve family functioning among parents of middle school-aged youth (grades 6-8th). A randomized control trial conducted through the University of Oregon found that parents who completed the Family Check-up Online program (FCO) either with or without supplemental support coaching exhibited significant increases in confidence and effortful control related to implementing skills and strategies that promote positive emotional and behavioral health among teens. This suggests that parents who complete the program feel more empowered to help guide their child's positive decision making and more effectively manage family challenges.

This project will examine whether the FCO program produces improvements in positive parenting practices, reductions in parental emotional distress, and reductions in youth emotional/behavioral problems when delivered as a universal prevention program targeting parents of 6-8th grade students attending Title 1 public schools (\>50% students eligible for free/reduced lunch). The investigators will also examine whether the structured parent coaching support component of the program (i.e., Guidance Coaching) helps to improve the program's effectiveness relative to a parent-initiated informational support condition.

Eligibility Criteria:
Inclusion Criteria:

* All parents with a child enrolled in grades 6-8 at participating Title 1 public schools will be invited to take part in the study.

Exclusion Criteria:

* N/A
Deep Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease

The primary objective of this trial is to assess the ability of Transcranial Magnetic Stimulation with H2 coil to prefrontal and parieto-temporal cortex to improve cognitive performance in patients with Alzheimer's disease which received drug treatment. This study is a single-center, double-blind 4 months duration trial.

Primary outcome measure: ADAS-COG (time frame baseline, 2 months, 4 months) Secondary outcome measure: CGI-C, Neuropsychological computerized test (Mindstream), FAB,ADL, Beck Depression Inventory-time frame baseline,1 month (visit 12) 2 months (visit 16), 4 months (visit 17).

Estimated enrollment: 45 patients Estimated Study start Date: November 2008 Estimated Study Completion date: November 2012 Number of arms: 3 Interventions details: H2 coil device for Transcranial Magnetic Stimulation with MAGSTIM to prefrontal and parieto-temporal regions bilaterally with frequency 10Hz in one arm, 1Hz in the second arm, and sham-stimulation with frequency 10Hz/1Hz in third arm.

Ages: 50-80 Genders: both

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent will be obtained
* diagnostic evidence of probable AD consistent with DSM IV
* stable treatment with Acetylcholine-Esterase Inhibitors or/and Memantine for 5 weeks prior to screening
* stable dose treatment with other drugs
* MMSE \<25

Exclusion Criteria:

* Patients with neurological or psychiatric disorders that affect cognition but are distinguishable from AD
* Patients who are unwilling or unable to fulfill the requirements of the study
* Severe personality disorder
* Malignant or untreated Hypertension
* History of Epilepsy
* History of Head trauma
* Metal implant in head, cardiac pacemaker, medical pump
* Drug or alcohol addiction
* Involvement in any other clinical trial during the preceding 3 month
* Patient who are unwilling or unable to give Informed Consent
The Efficacy of KIDNET in the Treatment of Traumatized Refugee Children in Germany

The purpose of the study is to assess the effectiveness of KIDNET in treating traumatized refugee children in Germany


Eligibility Criteria:
Inclusion Criteria:

* refugee children
* age range: 7-16
* PTSD-Diagnosis

Exclusion Criteria:

* none
ULTRAPREP Used to Perform Skin Antisepsis Outside the Operating Room

Testing ULTRAPREP (consists of a clear bag sealed on one end with the other end enclosing the patients extremity) for safety and efficacy to perform skin antisepsis outside the operating room.

The purpose of the study is to determine if ULTRAPREP is equal to or better than the conventional methods of preoperative skin antisepsis (the technique of cleansing the skin to help prevent infection) in surgical cases. The study will also help determine if ULTRAPREP will decrease the total amount of time in the operating room. The study will focus on whether or not using ULTRAPREP provides better patient flow and patient safety while improving a surgical staff's workload and workflow. The study includes 2 study arms:

Study Arm #1: the conventional method (or standard of care) will use an accepted skin disinfectant solution with ChloraPrep (70% isopropyl alcohol and 2% chlorhexidine). The solution is "painted" on the patient's skin using a sponge on a stick. The application time is with this method is 3 minutes plus 3 minutes for solution to evaporate. This is a widely-accepted method used in ORs. The preparation process is performed by surgical staff in the OR prior to surgery.

Study Arm #2: using ULTRAPREP bag containing ChloraPrep (70% isopropyl alcohol and 2% chlorhexidine). The bag will be placed on the patient's lower extremity in the holding area. The lower extremity will be scrubbed for 3 minutes. Once the patient is transferred to the OR, the solution will be suctioned out of the bag and the bag removed from the lower extremity to allow the solution to evaporate, this process take 3 minutes. the patient is then draped for surgery.

This study consists of 57 patients in each arm.

Sterile culture swabs will be taken from toenail beds and between toes or from fingernail beds and between fingers, depending on surgery site. The cultures will be taken preoperative before any disinfecting has begun and just before patient extremity is draped (after allowing 3 minutes for alcohol in disinfectant to evaporate). These sterile swabs will be taken to the lab for aliquot culturing to yield 6 pitre dishes for each swab. The CFUs (colony forming units) from each pitre dish will be counted and analyzed at 48 and 72 hours. A comparison will be made using the cultures in Arm 1 and Arm 2 to determine if the parameters of the study has been met.

Eligibility Criteria:
Inclusion Criteria:

* 18 or older
* Class 1 clean (as defined by The American College of Surgeons)
* Hand and Feet extremities

Exclusion Criteria:

* Open wounds
* Pregnant
* Emergency surgeries
* Class 2-4 (as defined by The American College of Surgeons)