cyrilzakka/clinical-trials huggingface dataset:
UBX-303061 in Subjects with Relapsed/Refractory B-Cell Malignancies

This is a first-in-human Phase 1a/1b multicenter, open-label study designed to evaluate the safety and anti-cancer activity of UBX-303061 in patients with relapsed/refractory B-cell malignancies.


Eligibility Criteria:
Key Inclusion Criteria

* Capable of giving signed informed consent
* Age ≥18 years
* ECOG performance status ≤2.
* Phase Ia (dose-escalation part only): Subjects with relapsed and/or refractory B-cell malignancies (CLL/SLL, DLBCL, FL, MCL, WM or MZL) who have received at least 2 prior therapies and for subjects with no available treatment options as per the Investigator's discretion.
* Phase Ib (dose-expansion only): Subjects with relapsed and/or refractory B-cell malignancies who have received at least 2 prior therapies and for subjects with no available treatment options as per the Investigator's discretion, and fit into one of the following groups: CLL/SLL or DLBCL or MCL or FL, WM, MZL
* All subjects must have evaluable or measurable disease based on the appropriate tumor type criteria
* Adequate organ and bone marrow function

Key Exclusion Criteria

* For subjects with lymphoma:

  * Systemic antineoplastic therapy or any experimental therapy within 3 weeks or 5 half-lives, whichever is shorter, before the first dose of study treatment.
  * Therapy with tyrosine kinase inhibitor within 5 half-lives before the first dose of study treatment.
  * Unconjugated monoclonal antibody therapies \<6 weeks before the first dose of study treatment.
  * Subjects that have undergone autologous stem cell rescue within 100 days prior to the first dose of study treatment.
  * Subjects that have undergone allogeneic stem cell transplant within 6 months prior to the first dose of study treatment.
  * Subjects with active graft-versus-host disease (GVHD) or on anti-GVHD treatment or prophylaxis.
  * History of chimeric antigen receptor T cell (CAR-T) therapy within 100 days prior to start of study drug.
  * Any immunotherapy within 4 weeks of first dose of study drug.
  * The time from the last dose of the most recent chemotherapy or experimental therapy to the first dose of study drug is \<5 times the t1/2 of the previously administered agent(s).
* Previously exposed to BTK degradation therapy
* Malignant disease, other than that being treated in this study.
* Radiotherapy within 2 weeks of the first dose of study treatment
* Known hypersensitivity to BTK degraders or any of the ingredients.
* Impaired cardiac function or clinically significant cardiac disease
* Subjects with history of severe bleeding disorders and known/suspected other autoimmune disease
* Major surgery within 4 weeks of the first dose of study treatment
A Pilot Surveillance Study to Monitor Natural Killer Cells and Circulating Tumor Cells in Women With Previously Treated Non-metastatic Triple Negative Breast Cancer and Women With Previously Treated Non-metastatic Breast Cancer With a Confirmed BRCA Mutation.

The purpose of this research study is:

* To test blood for the presence of tumor derived circulating tumor cells (CTCs) or circulating tumor DNA (ctDNA) using an investigational medical device called the LiquidBiopsy®. Using the LiquidBiopsy® platform, recovered cells or DNA can also be investigated to obtain genetic information that may be useful to treating physicians in understanding disease.
* To test blood for natural killer cells (NK cells), which are part of the body's natural immune defense against tumors. A device called the NK VueTM Kit will be used for this test.

The LiquidBiopsy® is a new investigational device. An investigational device is one that is not approved by the United States Food and Drug Administration (FDA). The NK VueTM Kit is an investigational device in the United States but is approved in Canada and South Korea as a class II device.

If a tumor is present, very tiny numbers of tumor cells or the contents of these tumor cells can get dislodged from the tumor and swept into the bloodstream. The LiquidBiopsy® device is able to purify the tiny numbers of tumor cells or ctDNA in the blood. Even if a tumor is too small to be found by other means such as an x-ray, it is possible that ctDNA or CTCs may be found in the blood. Genetic information can then be recovered from these cells or DNA to look for genetic changes that are related to the abnormal growth in a tumor. This will potentially allow researchers to study tumor cells or tumor DNA from a blood sample instead of a biopsy sample. This may influence cancer diagnosis, treatment and drug selection in the future.

NK cells occur naturally in the body and kill tumor cells. This study will measure the activity of the NK cells in blood. A strong correlation between low NK cell activity and increased circulating tumor cells in blood has been reported.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form.
* Female.
* Over 18 years of age.
* Previously Treated Non-metastatic Triple Negative Breast Cancer or Women with Previously Treated Non-metastatic Breast Cancer With a confirmed BRCA Mutation who have completed therapy within three years of enrollment in this study.
* Subject may be invited to annual review of the Subject Information and Donation Schedule by email or mail follow up for five years after sampling.
* Subject provides written authorization for use and disclosure of protected health information (PHI).

Exclusion Criteria:

* Any conditions inappropriate for blood drawing.
* Known active viral or bacterial infection at time of blood draw.
* Known HIV, Hepatitis B, or Hepatitis C infection.
MRI DWI None-Gaussian Model Predicting Early Response to Immunotherapy in Digestive System Malignancies: a Prospective Observational Study

This is a prospective two cohorts observational study aimed to investigate the predicting value of MRI none-Gaussian model in digestive malignancies patients who received single agent PD-1/PD-L1 inhibitor or combined immunotherapy.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years, ECOG 0-1, expected survival ≥3 months;
* pathologically confirmed digestive system adenocarcinoma, including but not restricted to gastric adenocarcinoma, colorectal cancer, pancreatic adenocarcinoma et al;
* pathologically confirmed PD-L1 expression, or MMR-deficient (dMMR)/microsatellite instability (MSI-H) or high tumor mutation burden (TMB-H) or other indication for immunotherapy;
* at least one target lesion, if there is no target lesion the thickness of cavity viscera lesion should exceed 1cm;
* patients will receive single agent PD-1/PD-L1 inhibitor, or combined immunotherapy such as: lenvatinib, enrotinib or herceptin;
* screening laboratory values must meet the following criteria: hemoglobin ≥ 9.0 g/dL; neutrophils ≥ 1500 cells/ μL; platelets ≥ 100 x 10\^3/ μL; total bilirubin ≤ 2.0 x upper limit of normal (ULN); aspartic transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN without, and ≤ 5 x ULN with hepatic metastasis; serum creatinine ≤1.5 x ULN, and serum creatinine rate \>50μmol/L; activated partial thromboplastin time (APTT)、international normalized ratio (INR), prothrombin lime (PT)≤1.5×ULN;
* echocardiography: left ventricular ejection fraction≥50%
* volunteer participate, signed written informed consent form.

Exclusion Criteria:

* claustrophobia or other contraindication for MRI testing;
* received prior anti-PD-1/PD-L1 or other immune checkpoint inhibitors;
* combined immunotherapy contains chemotherapy agent;
* contain other histology component except adenocarcinoma；
* hypersensitivity after other monoclonal antibody infusion；
* coexist other malignancy in last five years;
* active autoimmune disease, or who received systemic treatment with corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 2 weeks of first dose;
* Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage;
* obvious bleeding tendency or had CTCAE≥3 grade；
* subjects are eligible with clinically controlled and stable neurologic function ≥ 4 weeks, which is no evidence of CNS disease progression; subjects with spinal cord compression and cancerous meningitis are not eligible；
* vaccination within 28 days of the first administration of trial treatment.
Surgical Approach in Hemiarthroplasty. A Randomized Clinical Trial Comparing Posterior and Anterior Approach

Dislocated femoral neck fractures are routinely treated with cemented hemiartroplasty and the direct lateral approach (Hardinge) has commonly been used in Norway. The investigators have lately witnessed a significant change in the prefered surgical approaches in total hip arthroplasty (THA) in favor of the posterior and anterior approaches. The direct lateral approach has in THA, more or less, been abandoned in Norway. Numerous studies have reported superior results using the posterior and anterior approahes compared to the lateral approach.

The investigators have witnessed a marked change in preferred anatomical route to the hip joint when performing total hip artrhroplasty (THA) for osteoarthritis in Norway. The direct lateral approach, which 10 years ago dominated, is today more or less abandoned. Several studies have reported inferior results in patients operated with the lateral approach compared to the posterior and anterior approaches, the latter approaches used in approximately 95 % of all THA´s i Norway. Many approaches are known for hip arthroplasty in trauma patients, but there is little consensus on the preferred method. The preferred surgical approach varies among hospitals and surgeons. Identifying the best possible approach for HA could lead to shorter hospital admission, faster rehabilitation, better functional outcomes, lower morbidity and mortality and improvement in patient independence. Consequently healthcare costs related to a hip fracture could be reduced.

As of today the clinical results, reoperation rate and the morbidity have improved significantly in hemiarthroplasty treatment for dislocated femoral neck fractures. However, patients are primarily operated with the lateral approach, although inferior results are reported compared to posterior and anterior approaches. RCT´s from Ugland et al and Mjaaland have shown increased incidence of limping, lateral thigh pain and inferior PROM´s in patients operated with the direct lateral approach compared to patients operated with anterior approaches.

A meta-analysis regarding hemiarthroplasty and surgical approaches from 2018 concluded that high-quality comparative studies are needed to further substantiate the preferred anatomic route for hemiarthroplasty in older femoral neck fracture patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 70 and 90 years of age
* Displaced FNF
* Ability to walk with or without a walking aid prior to falling
* Patients having Sorlandet Hospital as primary service provider for orthopaedic trauma
* Provision of informed consent by patient or proxy
* Low energy fracture (fall from standing height, no other major trauma)

Exclusion Criteria:

* Dementia
* Fractures in pathologic bone
* Patients not suited for HA (i.e., inflammatory arthritis, severe osteoarthritis)
* Associated major injuries of the lower extremity ( i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula or femur)
* Retained hardware around the affected hip that will interfere with arthroplasty
* Sepsis or local infection
Efficacy of Home Blood Pressure Monitoring (MONITOR Study)

High blood pressure is the main risk factor for cardiovascular disease worldwide,but its control rate is unsatisfactory. Home Blood Pressure Monitoring (HBPM) with automatic oscillometric devices and pharmaceutical care have been proposed as interventions to increase therapeutic compliance and to guide treatment decisions.

The purpose of this study is to evaluate the effect of HBPM and of pharmaceutical care in blood pressure control measured through 24h ambulatory blood pressure monitoring (ABPM).

Home Blood Pressure Monitoring (HBPM) and Pharmaceutical care have been proposed to improve therapeutic compliance and to guide treatment decisions, but their effects on BP control are still under debate.

This is a factorial randomized controlled trial including adult hypertensive patients under drug treatment but with office BP and 24h ABPM uncontrolled. Participants will be allocated to one of four groups: HBPM; HBPM and Pharmaceutical care; Pharmaceutical care; or control. All participants will receive usual care for high blood pressure. Participants will be followed for 60 days.

Eligibility Criteria:
Inclusion Criteria:

* Office BP ≥140/90 mm Hg
* 24h ABPM hypertension BP ≥130/80 mm Hg
* using at least one antihypertensive drug

Exclusion Criteria:

* BP ≥ 180 / 110 mmHg)
* major cardiovascular events in the last six months
* acute or chronic diseases limiting the capacity to understand and to participate in the trial
* masked hypertension
* white-coat hypertension
* secondary hypertension
* pregnancy
* breastfeeding
* concurrent participation in another trial
The Effect of Iyengar Yoga Practice on Patients with Multiple Sclerosis

The aim of this work is to find out what effect the practice of Iyengar yoga has on patients with multiple sclerosis on the EDSS 5 and more, specifically in the field of mobility, self-sufficiency and anxiety.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 years
* diagnosis of multiple sclerosis
* EDSS grade 5 or higher

Exclusion Criteria:

* age less than 18 years
* the patient is not diagnosed with multiple sclerosis EDSS grade less than 5
* refusal of the subject to participate in the study
Knee Steroid Injection and Blood Sugar Signatur

A prospective, observational study assessing the relationship between HbA1c level and the post-injection blood glucose signature. Participants will be non-diabetic, pre-diabetic, non-insulin dependent and insulin dependent type 2 diabetic patients who will be receiving a knee steroid injection. All of them will be consented a week prior to the injection, when the CGM sensor will be applied to the back of the upper arm. This will be removed a week after the injection. KOOS survey as well as VAS will be administered. Adverse events (e.g., change in medication or hospitalization) will be monitored throughout the study.


Eligibility Criteria:
Inclusion Criteria:

* Patients at the Parkland Outpatient Clinic
* Indication for unilateral knee joint steroid injection for the treatment of knee joint osteoarthritis

Exclusion Criteria:

* Less than 18 years old
* HbA1c \> 12.0%
* steroid exposure in the 3 months prior to Visit 1
* 3 or more steroid injections in the preceding 12 months
* known contraindication to steroid injection (adverse reaction or allergy, active infection, INR \> 3.0)
* lack of improvement with prior knee steroid injection
* change in diabetic medication regimen in the last 1 month
* significant change in diet within the last 1 month
* current use of aspirin
* allergy to adhesive
* planned MRI, XR, or CT during the 2-week study period
Nutritional Deficiency After Bariatric Surgeries

comparing micro-nutrient deficiencies in postoperative morbid obese patients who will be undergoing gastric bypass and sleeve gastrectomy with regards to vit B 12, vitamin D,iron studies and calcium .

The General surgery department will be reviewed for a period of six months duration. All patients who admitted to the department and subjected to laparoscopic GP and SG during the study period will be included in the study after securing an informed consent; both written and verbal consent approved by the Sohag Ethics Committee will be taken from all patients included in the study.

Patients will be followed for one year by laboratory testing of CBC, serum ferritin, and vitamin B 12, vitamin D and ionized serum calcium after the 1st month, 3rd month, 6th month, and then after one year postoperative.

The pre-operative and post-operative measures will be compared in patients who will be subjected to Laparoscopic Sleeve Gastrectomy versus Laparoscopic Gastric Bypass.

Eligibility Criteria:
Inclusion Criteria:

1. Age from 18 to 65.
2. BMI more than 40 and more than 30 with co morbidities
3. Both sexes with history of failed weight loss attempts in the past for two years and good motivation for surgery.

Exclusion Criteria:

1. Age less than 18, more than 65.
2. Revisional bariatric surgery.
3. Previous gastric surgery
4. Patients with endocrinal disturbance except hypothyroidism and DM
5. Psychological disturbed patients
6. Females during pregnancy
Post Extubation Delirium and End-tidal Sevoflurane Concentration

The purpose of this study is to determine whether the incidence of emergence delirium will be reduced when end-tidal concentration of sevoflurane decreases.

Sevoflurane induction and maintenance were selected. Intubation was performed after lidocaine spray on vocal cord. After that, an effective caudal or brachial plexus block was performed. End-tidal concentration of sevoflurane was maintained at 2.5%. Spontaneous respiratory was maintained. Sevoflurane was stopped after the end of surgery. Patients were randomly assigned to 2 groups: high concentration group (Group HC, end-tidal concentration of sevoflurane when extubating \>=0.5%) and low concentration group (Group LC, end-tidal concentration of sevoflurane when extubating \<0.5%). Patients in Group LC were extubated when they coughed or purposeful movement appeared. The patients whose end-tidal concentration of sevoflurane \>= 0.5% were excluded. Patients in Group HC were extubated when any of the criteria was met: 1.the patient coughed or purposeful movement appeared 2.end-tidal concentration of sevoflurane decreased to 0.5%. A trained nurse (blind to groups) recorded PAEDs scores in PACU.

Eligibility Criteria:
Inclusion Criteria:

* Age 2-7 years
* ASA I - II
* Estimated surgery time \< 2 hours
* Sevoflurane induction and maintenance along with caudal block or Axillary Block

Exclusion Criteria:

* Craniofacial anomalies
* Difficult exposure of the vocal cordS
* Obesity
* Asthma
* Invalid caudal block or axillary block
Women Helping Women - Lung Cancer Screening

The Women Helping Women Lung Cancer Screening (WHW-L) Study will be conducted to develop a scalable, easy to apply community-based intervention to increase rates of lung cancer screening and follow-up in high-need/low-resource populations, based on a Transtheoretical Stages of Change theoretical model. The investigators will test the feasibility of using Community Health Workers to recruit (Aim 1) and partner with 60 community members (Aim 2) within 6 months, to take the steps to consult with a doctor, schedule screening, and/or attend screening (Aim 3) \[84 people may be screened for the study assuming some don't continue}.CHWs will use the HealthStreet 12,000+ cohort to identify current or former female smokers (adults 50 to 77 years old) with a smoking history of 25 pack-years who could benefit from LDCT screening for lung cancer and will facilitate steps in their screening receipt. All participants will benefit from the Standard Intervention; additionally, a random sample of 30 will receive the Enhanced CHW Intervention (E-CHW-I). The investigators hypothesize that women who may be at higher risk of lung cancer due to lack of knowledge, access, and resources will take steps to receipt of LDCT in both interventions, with those receiving the Enhanced Intervention more likely to take these steps. Ultimately, such an intervention could lead to a lower lung cancer burden in the target population


Eligibility Criteria:
Inclusion Criteria:

* women who are 50 to 80 years old
* 20+ pack-years of smoking history
* live within 45 miles of UF Health Shands Hospital or in Duval County, specifically the 12,000+ HealthStreet cohort

Exclusion Criteria:

* women outside the acceptable age range
* insufficient smoking history
* women who live outside the 45 miles of UF Health Shands Hosptial or not in Duval County not in the HealthStreet system
Study of HS-10384 in Participants of Chinese Postmenopausal Women

A randomized, double-blind, placebo-controlled phase Ib clinical study to evaluate the safety, tolerability and pharmacokinetics characteristics of HS-10384 in Chinese postmenopausal women.

Phase Ib is consisted with 3\~4 multiple ascending doses.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects should fully understand the content, process and possible adverse reactions of the study, and voluntarily sign the informed consent form;
2. Age between 40 and 65 years old (including the critical value);
3. The body mass index (BMI=body weight \[kg\]/height2 \[m2\]) at screening is 19\~28 kg/m2 (including the critical value of 19), and the weight is ≥ 40 kg;
4. Subjects are postmenopausal women at screening as qualified by any of the following criteria: spontaneous amenorrhea ≥ 12 months, or spontaneous amenorrhea ≥ 6 months and FSH\>40 IU/L (without other obvious pathological or physiological reasonsbefore screening), or documented surgical sterilization (such as hysterectomy, bilateral salpingectomy or bilateral oophorectomy, etc.);
5. From 48 hours before taking drug to the end of the study, subjects should avoid taking tobacco products, alcohol and other foods or drinks that might affect drug metabolism (such as coffee, tea, cola or other caffeinated drinks);
6. The blood pregnancy test of female subjects at baseline period is negative.

Exclusion Criteria:

1. Participants with disease history of uterine bleeding, uterine ovarian tumor, pituitary tumor, or other diseases evaluated by the principal investigator as not suitable for this study;
2. Have a history of migraine within 3 months before screening;
3. Participants with clinically significant diseases (such as neuropsychiatric system, cardiovascular system, urinary system, digestive system, respiratory system, skeletal muscle system, endocrine and metabolic system, blood system, skin disease, immune system, tumor, etc.) were evaluated by the researcher as not suitable for this study;
4. Within 2 weeks before screening, participants have suffered from VMS that inducing the interrupt of daily activities;
5. Within 30 days before taking drug, participants have taken hormonal treatment or other therapy due to VMS;
6. Within 4 weeks or 5 half-lives (whichever is longer) before screening, and during the whole study period, it is expected to take any medicine and health care products, including prescription drugs, immunomodulator or Chinese herbal medicine, etc.;
7. Within 3 months before screening, participants have taken hormonal contraceptive;
8. Participants have participated in any clinical study or taken study drugs within 3 months before screening;