cyrilzakka/clinical-trials huggingface dataset:
Highly Selective CDK7 Inhibitor Q901 in Selected Advanced Solid Tumors

Multicenter, open-label, dose-escalation, safety, tolerability, PK and pharmacodynamic study with a dose expansion at the RP2D to evaluate safety and potential antitumor activity of Q901 as a monotherapy and in combination with pembrolizumab


Eligibility Criteria:
Inclusion Criteria:

* Participants with histologically or cytologically confirmed advanced or metastatic ovarian, CRPC, HR+ HER2- breast, endometrial, colorectal, small-cell lung, or pancreatic cancer, who have progressed following standard-of-care therapy or for whom there is no standard therapy that confers clinical benefit
* Measurable disease per RECIST v 1.1
* ECOG performance status 0,1 or 2
* Life expectancy of at least 3 months
* Age ≥ 18 years
* Signed, written IRB-approved informed consent form

Exclusion Criteria:

* New York Heart Association Class III or IV cardiac disease, or myocardial infarction, severe unstable angina, coronary/peripheral artery bypass graft, congestive heart failure within the past 6 months
* Have a corrected QT interval (using Fridericia's correction formula) (QTcF) of \>470 msec (females) and \>450 msec (males)
* Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy
* Active, poorly controlled autoimmune or inflammatory diseases
A Regulatory Post Marketing Surveillance (rPMS) Study of Ryzodeg® FlexTouch® (Insulin Degludec /Insulin Aspart) to Evaluate Safety and Effectiveness in Patients With Diabetes Mellitus in Routine Clinical Practice in Korea

The purpose of this study is to collect information about safety and effectiveness of Ryzodeg® FlexTouch® in participants with diabetes mellitus requiring insulin therapy under routine clinical practice conditions with the aim of identifying or quantifying a safety hazard, early detection of unknown safety problems. Participants will attend the clinic/hospital/medical institution according to usual practice and receive medical care, as agreed with the study doctor.


Eligibility Criteria:
Inclusion Criteria: - The decision to initiate treatment with commercially available Ryzodeg® FlexTouch® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study - Signed informed consent obtained before any study related activities. Study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study - Age equals to or more than 2 years at the time of signing informed consent with diabetes mellitus (Type 1 or Type 2) and who is scheduled to start treatment with Ryzodeg® FlexTouch® based on the clinical judgment of their treating physician as specified in the Korean-Prescribing information (K-PI) Exclusion Criteria: - Patients who are or have previously been on Ryzodeg® FlexTouch® therapy - Known or suspected hypersensitivity to Ryzodeg® FlexTouch®, the active substance or any of the excipients - Previous participation in this study. Participation is defined as having given informed consent in this study - Female patient who is pregnant, breast-feeding or intends to become pregnant and is of childbearing potential and not using adequate contraceptive methods(adequate contraceptive measures as required by Korea regulation or practice) - Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
Travelling for Rights

This will be a retrospective cohort study comparing women obtaining an abortion in New Mexico and living in Texas and women obtaining an abortion in New Mexico and living in New Mexico .

This will be a retrospective cohort study comparing women obtaining an abortion in New Mexico and living in Texas and women obtaining an abortion in New Mexico and living in New Mexico in two different time periods (time period #1 is from January 1 2012-December 31 2012 and time period #2 is from May 1 2014-April 30 2015. Our exposure is a state in which a woman lives in (New Mexico or Texas). Our intervention is the change in Texan laws occurring from July 2013-January 2014.

Eligibility Criteria:
Inclusion Criteria:

* Women obtaining an induced abortion at one of the following clinics:

University of New Mexico's Center for Reproductive Health (UNM CRH), Planned Parenthood - Albuquerque Surgical Center or Southwestern Women's Options.

* Women residing in Texas or New Mexico. -Women obtaining an induced abortion between January 1 2012-

Exclusion Criteria:

* No chart available for data extraction
* Gestational age at time of abortion initiation ≥ 24 weeks gestation as determined by ultrasound imaging.
HBV Virions Bound Proteins

The emergence of hepatocellular carcinoma (HCC) has prompted a search for a thorough understanding of the biology of one of its major causative agents, the hepatitis B virus (HBV). HBV particles acquire via budding and encapsidation cellular proteins. There is mounting evidence on several viral species that virion-bound proteins are prone to be involved either at the replication, budding/egress or entry/release steps of the viral cycle.

Identifying such targets may yield ideal candidates for gaining insight on the dependence of HBV upon a restricted subset of host proteins, therefore providing refined sets of genetically stable targets for therapy. This project's goals are to set up adequate conditions for robust and reproducible purification of HBV virions in clinical samples, followed by the identification of their HBV-bound host proteins and the characterization of their functions. Proteomics profiling of HBV particles purified from clinical samples will be overlaid with proteins identified and characterized in cell culture grown HBV particles, using clinical biomarker discovery grade criteria. Targets identified in both samples sets will be subjected to in vitro investigations using HBV-replicating cells. Conventional biochemical and imaging methods will be used in order to: (i) ascertain their physical association with HBV virions; (ii) define the modalities of their interaction with HBV proteins; (iii) decipher the topology and subcellular localization of their association with HBV proteins and virions; (iv) quantitatively assess their functional involvement in particle budding, egress or secretion and infectivity. A candidate that yielded satisfactory results in these experiments will be disclosed and further investigated at the level of structural biology, in collaborative research programs.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria
* Adult\> 18 and \<60 years
* Infected with HBV.
* positive viremia for more than 6 months
* Viremia\> 106 IU / ml.
* Immunotolerant individuals, untreated
* Aviraemic individuals,

Exclusion Criteria:

* patient with against-indication for a blood sample of 150 ml
* immunosuppressive therapy patient
* Patient with liver disease other than hepatitis B.
* patient with hepatocellular carcinoma.
* Patients with one or more severe co-morbidities defined as:
* Co-infection with HIV or hepatitis C virus (HCV).
* hematological malignancies changing or aplasia
* Insulin-dependent diabetes
* dialyzed chronic renal failure
* Heart failure
* Persons subject to legal protection or the subject of a safeguard measure of justice
* not affiliated with a social security scheme or not beneficiaries of such a scheme
* Pregnant women
Comparison of 4-weeks of Motor Relearning Program and Mirror Therapy in Improving Upper Limb Motor Function in Stroke Patients.

Cerebrovascular accident(CVA) or stroke is one of common condition affecting people in developed and underdeveloped countries.

MRP is a therapy to regain particular motor function and neglecting accessory movements by engaging cognitive behavior.

Mirror therapy enhance functional activities in patient with hemiplegic stroke. For betterment of result high quality methodological studies and larger sample size is required.

Cerebrovascular accident(CVA) or stroke is one of common condition affecting people in developed and underdeveloped countries. Mostly patient with stroke face many disabilities and the most important one is upper limb motor impairment. For the optimization of upper extremity and prevention of patient from permanent disability it is essential to promotes Neuro-rehabilitation interventions. Physiotherapy techniques need to be monotonous, thorough and task oriented for neuroplasticity to generate better recovery. There is notable enhancement in ADLS when the rehabilitation program starts within 16 hours to 6 months after stroke In improving upper extremity motor functions there are tremendous types of techniques used i.e. Proprioceptive neuromuscular facilitation(PNF),Brunnstorm, Bobath therapy, Motor relearning program(MRP),Constraint induced movement therapy(CIMT) and Mirror therapy(MT).Out of which we are using two basic techniques i.e. motor relearning program(MRP) and mirror therapy(MT).Mirror therapy enhance functional activities in patient with hemiplegic stroke. For betterment of result high quality methodological studies and larger sample size is required. Mirror therapy enhance functional activities in patient with hemiplegic stroke. MRP is a therapy to regain particular motor function and neglecting accessory movements by engaging cognitive behavior .MRP is a therapy to regain particular motor function and neglecting accessory movements by engaging cognitive behavior.

Eligibility Criteria:
Inclusion Criteria

* Acute(hemiplegic attack within 1-2 weeks) and sub-acute stroke(hemiplegic attack within 3- 11 weeks).
* 20 to 80 years.
* No physical deformity prior to stroke
* No history of serious underlying pathology and structural deformities.

Exclusion Criteria:

* Patient with chronic hemiplegic stroke.
* Patient with congenital deformity.
Effects of Tai Chi Chuan in Patients After Recent Acute Myocardial Infarction

This is a randomized Clinical Trial to assess the effects of Tai Chi Chuan on blood pressure, respiratory muscle strength and functional capacity in patients after recent acute myocardial infarction.

Background:Patients with a recent myocardial infarction (MI) present a reduction in functional capacity expressed as a decrease in peak oxygen consumption (VO2 peak). The impact of a Tai Chi Chuan (TCC) cardiac rehabilitation program for patients recovering from recent MI has yet to be assessed. Our goal is to evaluate functional capacity after a TCC-based cardiac rehabilitation program in patients with recent MI.

Methods: A single-blind randomized clinical trial was conducted. The researchers who performed the tests were blinded to group allocation. Between the 14th and 21st days after hospital discharge, all patients performed a cardiopulmonary exercise testing and a laboratory blood workup. Mean age was similar (56 ± 9 years in the TCC group and 60 ± 9 years in the control group). Patients allocated to the intervention group performed 3 weekly sessions of TCC Beijin style for 12 weeks (n = 31). The control group participated in 3 weekly sessions of full-body stretching exercises (n = 30).

Eligibility Criteria:
Inclusion Criteria:

* Recent acute myocardial infarction
* Age 45 and 75 years.
* admission until 20 days after hospital discharge
* With physical conditions for a cardiac rehabilitation program with exercise.

Exclusion Criteria:

* Unstable angina
* Severe congestive heart failure
* Severe lung disease
* Altered response of blood pressure to stress
Feasibility Open Label Study Evaluating The Use Of Process-Instructed Self Neuro-Modulation (PRISM) For Post-Traumatic Stress Disorder

This is a single-arm, open-label feasibility study. A maximum of 15 participants will be enrolled. All participants will undergo a novel neurofeedback intervention, targeting down-regulation of deep limbic structures, specifically the amygdalae. Participants will complete 12 neurofeedback sessions delivered twice weekly over 6 consecutive weeks. The intervention will be delivered via the PRISM platform.


Eligibility Criteria:
Inclusion Criteria:

* Adults ages 18-65 years
* Able to provide signed informed consent
* Any gender
* Diagnosis of PTSD as established by DSM-V
* 1 to 15 years since index trauma
* Taking a stable dose of SSRI antidepressants for at least 3 months OR un-medicated for at least 2 months
* Normal or corrected-to-normal vision
* Normal or corrected-to-normal hearing
* No intention of changing medication or psychotherapy for the duration of the study at the time of recruitment

Exclusion Criteria:

* Concurrent substance abuse
* Use of any prescribed benzodiazepine
* Lifetime bipolar disorder, psychotic disorder, autism, mental retardation. Comorbid mood and anxiety disorders will be permitted if they are not the primary focus of clinical attention
* Active suicidality within past year, or history of suicide attempt in past 2 years
* Any history of severe past drug dependence (i.e., a focus of clinical attention or a cause of substantial social or occupational difficulty)
* Any unstable medical or neurological condition
* Any history of brain surgery, of penetrating, neurovascular, infectious, or other major brain injury, of epilepsy, or of other major neurological abnormality (including a history of traumatic brain injury \[TBI\] with loss of consciousness for more than 24 hours or posttraumatic amnesia for more than 7 days)
* Any psychotropic medication other than a stable dose of selective serotonin reuptake inhibitors (SSRIs)
* Any change in accepted psychotropic medication within the past 2 months
* Recent initiation (within the past 3 months) of cognitive-behavioral therapy or any evidence-based PTSD psychotherapy (Cognitive Processing Therapy \[CPT\], Prolonged Exposure \[PE\], Eye Movement -Desensitization and Reprocessing \[EMDR\]); continuation of established maintenance supportive therapy will be permitted
* Significant hearing loss or severe sensory impairment
* Enrollment in another research study testing an experimental, clinical, or behavioral intervention intended to affect symptoms initiated within the last 2 months, or intended enrollment within the next 2.5 months
The Effect of LY2409021 on Blood Sugar Levels When Glucagon Levels Are Increased in Healthy Male Participants

This is a study to measure the effect that various doses of LY2409021 have on blood sugar levels and on the amount of glucose released by the liver, when glucagon is given to increase these. Each participant may receive up to 2 single doses of LY2409021 in 2 different study periods, with a minimum 13-day washout between dosing periods. This study is approximately 9 weeks long, not including screening. A screening appointment is required within 6 weeks prior to the start of the study.


Eligibility Criteria:
Inclusion Criteria:

* Must be a healthy male
* Have a screening body mass index (BMI) of 18.5 to 29.9 kg/m\^2 inclusive
* Have a fasting blood glucose between 3.0-6.0 millimoles/liter (mmol/L) (inclusive) at screening

Exclusion Criteria:

* Are allergic to LY2409021, insulin, glucagon, somatostatin, or similar drugs
* Have a regular alcohol intake greater than 21 units/week, or are unwilling to stop alcohol as required by the study restrictions (1 unit = 360 mL of beer, or 150 mL of wine, or 45 mL of spirits)
* Are currently smokers or have used tobacco products on a regular basis in the 6 months prior to screening
* Have received any medication known to affect glucose metabolism in the 1 month before the study
* Have a significant blood disorder and/or donated blood (450 mL or more) in the last 3 months
Study to Evaluate the Safety and Efficacy of KITE-585 in Participants With Relapsed/Refractory Multiple Myeloma

The primary objective of the study is to evaluate the safety and tolerability of KITE-585, an autologous engineered chimeric antigen receptor (CAR) T-cell product targeting a protein commonly found on myeloma cells called B-cell maturation antigen (BCMA), as measured by the incidence of dose-limiting toxicities (DLTs). Participants will be given a 3 day course of conditioning chemotherapy followed by a single infusion of KITE-585.

Participants with relapsed/refractory multiple myeloma can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, ECG and echocardiogram of the heart, brain MRI, and blood draws. Eligible participants have white blood cells collected by leukapheresis. These cells are genetically modified to make the experimental treatment KITE-585. Participants receive conditioning chemotherapy prior to the KITE-585 infusion. After the KITE-585 infusion, participants will be followed for side effects and effect of KITE-585 on their myeloma. Study procedures may be performed while hospitalized and/or in the outpatient setting. Participants who received an infusion of KITE-585 will complete the remainder of the 15 year follow-up assessments in a separate long-term follow-up study, KT-US-982-5968

Eligibility Criteria:
Key Inclusion Criteria:

1. Measurable relapsed or refractory myeloma as defined by the International Myeloma Working Group (IMWG) Consensus Criteria following treatment with at least 3 lines of therapy including with both a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), or progressive myeloma that is refractory to a regimen containing both a PI and an IMiD.
2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
3. Adequate bone marrow, renal, hepatic, pulmonary, and cardiac function defined as:

   * Absolute neutrophil count (ANC) ≥ 1,000/µL
   * Platelet count ≥ 75,000/µL
   * Absolute lymphocyte count ≥ 100/µL
   * Creatinine clearance above limits set in the protocol for each cohort
   * Normal cardiac function as assessed by electrocardiogram (ECG) and echocardiogram
   * Baseline oxygen saturation \> 92% on room air and no clinically significant pleural effusion

Key Exclusion Criteria:

1. Plasma cell leukemia
2. Non-secretory multiple myeloma
3. History of Central nervous system (CNS) involvement by multiple myeloma
4. Prior CAR therapy or other genetically modified T cells
5. Inadequate washout from prior therapy
6. Autologous stem cell transplant within 6 weeks before enrollment or any history of allogenic transplant
7. History of active autoimmune disease
8. History of deep vein thrombosis or pulmonary embolism requiring systemic anticoagulation within 6 months before enrollment
9. Recent history of other (non multiple myeloma) cancer
10. Active viral, fungal, bacterial or other infection

Note: Other protocol defined Inclusion/Exclusion criteria may apply
Goal Management Training in Individuals With PTSD

This study will evaluate the effect of a manualized treatment (Goal Management Training, or GMT) on the cognitive impairments associated with PTSD (Post-Traumatic Stress Disorder), as well as any impact on PTSD symptems themselves. Participants will be randomized to either GMT group treatment, or a wait list condition.

PTSD has an emotional impact on individuals, but it is also associated with impaired cognitive functioning (e.g., processing speed, attention, executive functioning). This study is an effectiveness trial investigating a cognitive remediation intervention (Goal Management Training, or GMT) that has been shown to improve the cognitive impairment observed in other populations (e.g., older adults). The present study will investigate the impact of GMT in adults experiencing PTSD (including frontline healthcare workers suffering from PTSD related to the COVID-19 pandemic) and its associated cognitive impairment. Participants will be randomly assigned to one of two treatment conditions - GMT, or a wait list condition (in which GMT will be postponed for approximately 21 weeks). Due to the pandemic, this study will be conducted primarily online (i.e., online assessments and treatment, with optional fMRI scans - functional magnetic resonance imaging). Once all assessments are complete, participants in the wait list condition will be able to begin GMT thelmselves.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of PTSD as determined by our baseline assessment
* Due to online nature: must have access to (and ability to use) a computer/tablet with a working microphone and camera (or webcam), reliable access to a secure internet connection, and access to a quiet, private space for the assessments and group sessions.
* Ability to provide informed consent
* Fluency in written and spoken English
* must be resident of Ontario (due to restrictions of professional licenses)

Exclusion Criteria for those opting in to fMRI scan:

* any implants, conditions, etc. that do not comply with 7T (Tesla) fMRI research safety standards (e.g., pacemaker, pregnancy/possible pregnancy)

Exclusion Criteria for study in general:

* history of significant head injury/lengthy loss of consciousness (e.g., a Glasgow Coma Scale Score \< 15 at the time of incident as assessed retrospectively by participant)
* significant untreated medical illness
* history of neurological or neurodevelopmental disorder
* history of any pervasive developmental disorder
* any medical disorder known to adversely affect cognition within the last 12 months
* lifetime bipolar or psychotic disorder
* alcohol/substance abuse or dependence within the last 3 months
* extensive narcotic use (e.g., fentanyl, oxycodone, etc.), use of anti-cholinergics, anti-psychotics, psychostimulants, or benzodiazepines
* ECT (electroconvulsive therapy) within the last 12 months
* significant dissociative disorder (as determined by our baseline assessment)
* suicide attempt in last 6 months
* pregnancy (due to impact of hormones on cognitive abilities)
* hearing or vision issues that would interfere with effective online participation