cyrilzakka/clinical-trials huggingface dataset:
Phase II Safety and Efficacy Study of Single-agent AT-101 in Patients With Relapsed or Refractory B-cell Malignancies

This is an open-label, multicenter, phase II study to evaluate the safety and efficacy of single-agent AT-101 in patients with relapsed or refractory B-cell malignancies.

This is an open-label, multicenter, phase II study to evaluate the safety and efficacy of single-agent AT-101 in patients with relapsed or refractory B-cell malignancies. For the purpose of this study, B-cell malignancies can include one of the following disease sub-types: follicular lymphoma (FL), diffuse large b-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), small lymphocytic lymphoma (SLL)/chronic lymphocytic leukemia. Patients will be enrolled according to disease subtype into one of four groups in two stages. The first stage of each group will enrolled 13 patients. If patients within any group experience disease response, an additional 14 patients will be enrolled into that group.

Eligibility Criteria:
Inclusion Criteria:

* Must have a histologically confirmed B-cell malignancy (defined as FL \[any grade\], DLBCL, MCL or SLL/CLL);
* Male or non-pregnant, non-lactating females age ≥18 years;
* Ability to swallow and retain oral medication.;
* Have failed at least one prior therapy and have documentation of either, relapsed disease, or refractory disease (i.e., no response or stable disease on their last regimen of therapy);
* ECOG performance status 0 or 1;
* All clinically significant toxicities from prior therapy must have fully resolved;
* Must have discontinued treatment with monoclonal antibodies for a minimum of 90 days prior to first dose of AT-101, or have objective documentation of disease progression if within 90 days of monoclonal antibody administration;
* Patients with FL, DLBCL, MCL, and SLL with normal lymphocyte counts must have at least one bi-dimensional lesion that is radiographically measurable (skin lesions, palpable lymph nodes, and bone marrow as the only site of disease are not considered measurable disease);
* Patients with SLL whose lymphocytes are elevated at baseline or CLL must have palpable lymph nodes and/or disease localized to the bone marrow per the NCI-Sponsored Working Group Guidelines for CLL.

Exclusion Criteria:

* Requirement of systemic corticosteroids within 7 days prior to and during AT-101 administration;
* Must not have received anti-cancer therapy within 28 days of first dose of AT-101. Cannot have received hormonal agents or biologic dose modifiers (with the exception of HRT) or any investigational treatments within 28 days of treatment with AT-101;
* Patients with CNS lymphoma, HIV-related lymphoma, symptoms suggesting HIV infection or active auto-immune hemolytic anemia are excluded;
* Previous treatment with gossypol, or are hypersensitive to its excipient are excluded;
* Patients who have an uncontrolled, concurrent illness are also excluded.
Safety Evaluation of a New Preservative in a Lubricating Eye Drop

This study is to evaluate the safety of a new preservative in a lubricant eye drop used four times a day in healthy adults and subjects diagnosed with dry eye.

Single-site, open-labeled study. Twenty two subjects will be enrolled into the healthy adult group and twenty two subjects into the dry eye group. Each subject will be in the study for approximately 2 weeks (treatment) and seen at three study Visits: Visit 1 (Day 0, Baseline), Visit 2 (Day 7 +/- 1) and Visit 3 (Day 14 +/- 1). Dosing regimen is 1-2 drops into each eye, four times daily, for two weeks. Assessments will be comprised of visual acuity, slit lamp biomicroscopy, fluorescein corneal staining, and product comfort.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Able to follow all study instructions and attend all required study visits
* Provide written informed consent
* Visual health and eye comfort within protocol-specified parameters
* Women of child-bearing potential must have a negative urine pregnancy test at screening, not be breast-feeding, and agree to use a protocol-specified acceptable form of birth control throughout the study

Exclusion Criteria:

* Any medical condition or history, or ocular scores, or use of any drug, device or medication that, per protocol or in the opinion of the investigator, might compromise the safety of the subject or analysis of the study results.
* Use of contact lenses outside protocol allowance
* Self-reported pregnancy, positive urine pregnancy test, breast-feeding; intends to become pregnant or breast-feed during the duration of the study, refuses protocol-specified urine pregnancy testing, and/or does not use protocol-specified birth control methods and agree to continue doing so for the duration of the study.
* Participated in an investigational drug or device trial within 30 days of entering the study.
Vitamin D Supplementation in Episodic and Chronic Tension-type Headache

The goal of this clinical trial is to learn about the effect of vitamin D in patients with prophylactic therapy for episodic and chronic tension-type headache in amitriptyline or topiramate treatment. The main question it aims to answer are:

• What is the effect of vitamin D in patients with prophylactic therapy for episodic and chronic tension-type headache?

Patients will have the next selection criteria:

* Patients diagnosed by a neurologist in the headache clinic
* Criteria for episodic and chronic tension-type headache
* Poor clinical response to prophylactic treatment (amitriptyline, topiramate)
* Use of at least 1 prophylactic medication or a history of having used them.
* Onset of disease between the ages of 18 and 60
* Signature of informed consent

The population will be randomly divided into the following 3 treatment groups:

* Participants amitriptyline or topiramate treatment.
* Patients with placebo (Calcium) + topiramate/amitriptyline,
* Participants with vitamin D3/calcium+topiramate/amitriptyline. Researchers will compare the groups to see if vitamin D can decrease the intensity of your headache and therefore have a new therapeutic option.

It will be a 4 month study. Each month a package containing treatment will be delivered, which may be conventional medication or tablets with conventional medication added with vitamins.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed by a neurologist in the headache clinic
* Criteria for episodic and chronic tension-type headache
* Poor clinical response to prophylactic treatment (amitriptyline, topiramate)
* Use of at least 1 prophylactic medication or a history of having used them.
* Onset of disease between the ages of 18 and 60
* Signature of informed consent

Exclusion Criteria:

* Patients with secondary headache (cranioencephalic trauma, cerebral infarction)
* Patients with primary headache other than tension headache
* Suffer heart, liver, and kidney diseases.
* Medications: thiazides
* Pregnant women
* They do not want to participate
Preconceptional Thyroid Screening and Childhood Nerocognitive Function

To assess the effect of universal preconception hypothyroidism for maternal pregnancy outcome, and 0-3yrs offspring neurocognitive ability and IQ score.

Epidemic evidence and animal studies suggested that hypothyroidism is related with maternal pregnancy outcome, offspring cognitive ability. Negro's study found improved maternal health in those screened in early trimester; while Lazarus et al. reported no significant offspring IQ score at 3yrs in universal screening in early trimester. Currently, it lacks evidence of universal pre-conception screening for maternal pregnancy outcome and offspring cognitive development, motivation ability, attention. China Governmental Health Department has included thyroid function screening into preconception in 2011. The investigators hypothesize that pre-conception effective treatment may be helpful for decrease possible negative effects on maternal and offspring health, instead of early trimester.

Eligibility Criteria:
Inclusion Criteria:

1. Preconceptional group：TSH ≥ 97.5%th and/or FT4 ≤ 2.5%th
2. age: 18-55
3. those who can obey the rules of this study and assign the consent

Exclusion Criteria:

1. age: less than 18 or more than 55
2. multiple pregnancy
3. thyroid tumor disease history
4. those who cannot obey the rules of this study
Influence of Supervised Stabilization Exercises on Postural Control in Patients After Spine Surgery.

The aim of the study is to determine the impact of early rehabilitation in patients after lumbar spine surgery using microdiscectomy on balance, postural stability and foot pressure distribution. The tests will be carried out at the Physical Effort Laboratory in Gdańsk.

Back pain (LBP) has become a major public health problem. In the case of pain in the lumbar spine, conservative or surgical treatment is used. In conservative treatment, patients undergo an appropriate rehabilitation program or use painkillers / anti-inflammatory drugs. When conservative treatment is unsuccessful, patients based on the MRI image and neurosurgical consultation are referred to the lumbar spine microdiscectomy. Therefore, patients consciously and voluntarily can start research on the effect of supervised exercises to stabilize the lumbar spine after single-level lumbar spine microdiscectomy on pain reduction, pressure distribution, balance, posture control, and basic functional tests.

Before the operation, during the first examinations, patients are informed about the ergonomic and behavioral procedure after the operation, and rehabilitation program. After surgery, a supervised exercise program begins three times a week for a month, lead by a qualified physiotherapist. Supervision is carried out online using generally available applications, including WhatsApp, messenger. After one month, patients are re-examined in the same way as before the surgery. The rehabilitation program after the microdiscectomy of the lumbar spine enables the voluntary extension of rehabilitation for another two months. During subsequent meetings with a physiotherapist, patients are taught new exercises that differ from week to week in terms of difficulty in performing, the number of repetitions, and the time to maintain tension.

Moreover, in the third month of the rehabilitation program, exercises with the use of a sensorimotor disc are planned. After completing the rehabilitation program, patients are invited for follow-up examinations six months and one year after the end of rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

* age 20 to 65 years, neurosurgical assessment and MRI imagine,discopathy, pernament low back pain with or without radiating to the lower limb.

Exclusion Criteria:

* patients beyond the age range, a previous lumbar spinal operation, spinal tumors, new fractures, intolerance of rehabilitation programs.
Bilateral Erector Spinae Plane Block in Paediateric Cardiac Surgery

ultrasound guided erector spinae plane block will be done for childern under going midline sternotomy for cardiac surgery. It is a novel block which is suspected to give powerful analgesia, decrease anaesthetic consumption and decrease awareness on cardiac bypass


Eligibility Criteria:
Inclusion Criteria:

* elective surgery
* childern between 4 and 10 years

Exclusion Criteria:

* emergency
* infection at injection site
* allergy to local anaestheics
TACE Combined Surgery for the Resectable Huge HCC

Huge hepatocellular carcinoma (HCC) is defined as a tumor with a maximum diameter greater than 10 cm. With advancements in surgical techniques, hepatectomy can be performed safely in some patients with huge HCC without vascular invasion or distant metastasis and with preserved liver function. The high risk of recurrence after surgery is another challenge for surgeons. Neoadjuvant TACE has been shown to improve the clinical outcomes of patients with HCC, especially those with a high risk of recurrence, such as those with multinodular tumors, large tumors, and tumor thrombus. The present multicenter study aimed to evaluate the efficacy of neoadjuvant TACE in patients with huge HCC who underwent liver resection.

Huge hepatocellular carcinoma (HCC) is defined as a tumor with a maximum diameter greater than 10 cm. With advancements in surgical techniques, hepatectomy can be performed safely in some patients with huge HCC without vascular invasion or distant metastasis and with preserved liver function. However, the 2-year recurrence rate in such cases is as high as 70%, indicating the need for more effective interventions to improve outcomes. Neoadjuvant TACE has been shown to improve the clinical outcomes of patients with HCC, especially those with a high risk of recurrence, such as those with multinodular tumors, large tumors, and tumor thrombus. The impact of neoadjuvant TACE on the long-term oncological outcomes of huge HCC requires investigation. The present multicenter study aimed to evaluate the efficacy of neoadjuvant TACE in patients with huge HCC who underwent liver resection.

Eligibility Criteria:
Inclusion Criteria:

1. clinical or pathological diagnosis of primary HCC;
2. tumor diameter \> 10 cm on images before inclusion;
3. age 18 to 75 years;
4. no macrovascular invasion or extrahepatic metastasis;
5. liver resection with complete removal of the tumor and adequate remnant liver volume;
6. albumin-bilirubin (ALBI) grade I and II;
7. Eastern Cooperative Oncology Group performance status (ECOG) score of 0-1;
8. hemoglobin level ≥ 8.5 g/dL, total bilirubin level ≤ 30 mmol/L, alanine transaminase (ALT) and aspartate aminotransferase (AST) levels ≤ 5 × upper limit of normal, serum creatinine level ≤ 1.5 × upper limit of normal;
9. prothrombin time ≤ 18 s or international normalized ratio \< 1.7.

Exclusion Criteria:

1. HCC with macrovascular invasion or extrahepatic metastasis;
2. tumor with a maximum diameter ≤ 10 cm on images before inclusion;
3. recurrent HCC;
4. serious medical comorbidities;
5. portal hypertension, including presence of either esophageal varices or splenomegaly with a platelet count less than 109/L;
6. cardiac ventricular arrhythmias requiring anti-arrhythmic therapy;
7. incomplete data or lost to follow-up within three months.
REnal TRansplant Outcomes After CARdiac Surgery (RETROCAR)

In this retrospective study, the authors assess long term renal outcome in renal transplant recipients after cardiac surgery with cardiopulmonary bypass, and research factors associated with poor long term renal outcome.

Post-operative mortality after cardiac surgery is increased in renal transplant recipients, compared with general population of cardiac surgery, or with kidney transplant recipients not undergoing cardiac surgery. If the survival of this specific population is now well studied, the long-term renal outcome is much less studied. Previous studies show a trend for increased risk of allograft dysfunction and need for permanent dialysis. This study proposes to compare long term renal outcome between renal transplant recipients and non-renal transplant recipients.

Eligibility Criteria:
Inclusion Criteria for Renal Transplant Recipients group:

* Previous renal transplantation
* Who underwent cardiac surgery with CPB

Inclusion Criteria for Non Renal Transplant Récipients group:

* No previous renal transplantation
* Who underwent cardiac surgery with CPB
* Apparied with Renal Transplant récipients with the 5 following criteria : age, sex, previous diagnosis of diabete, type of cardiac surgery (isolated coronary artery bypass graft, valvular surgery, aorta surgery, combined surgery), best glomerular filtration rate with CKD-EPI formula at +/- 15 ml/min, in the 3 pre-operative months

Exclusion Criteria:

* Patients requiring mechanical circulatory support (Extracorporeal Membrane Oxygenation)
* Pre-operative permanent dialysis
* Aorta dissection extended to renal arteries
* Non-elective surgery for infective endocarditis
* Previous hepatic, pancreatic or cardiac transplantation
* Death in the 30 first days after cardiac surgery
* Patient not meeting the inclusion criteria
Project 3: ACHIEVE- CHD

This project is part of the ACHIEVE GREATER (Addressing Cardiometabolic Health Inequities by Early PreVEntion in the GREAT LakEs Region) Center (IRB 100221MP2A), the purpose of which is to reduce cardiometabolic health disparities and downstream Black-White lifespan inequality in two cities: Detroit, Michigan, and Cleveland, Ohio. The ACHIEVE GREATER Center will involve three separate but related projects that aim to mitigate health disparities in risk factor control for three chronic conditions, hypertension (HTN, Project 1), heart failure (HF, Project 2) and coronary heart disease (CHD, Project 3), which drive downstream lifespan inequality. All three projects will involve the use of Community Health Workers (CHWs) to deliver an evidence-based practice intervention program called PAL2. All three projects will also utilize the PAL2 Implementation Intervention (PAL2-II), which is a set of structured training and evaluation strategies designed to optimize CHW competence and adherence (i.e., fidelity) to the PAL2 intervention program. The present study is Project 3 of the ACHIEVE GREATER Center.


Eligibility Criteria:
Inclusion Criteria:

1. 40 to 75 years of age
2. Self-identified as Black or African American
3. Residence in the Cleveland Metro Area
4. Must have at least two of the following risk factors identified at a UH health fair screenings, with one risk factor being with SBP, A1c, or LDL:

   1. BMI≥30 mg/dL
   2. History of smoking
   3. Elevated blood pressure defined as SBP\>140 or DBP\>80 mmHg
   4. HbA1c≥5.7%
   5. LDL≥130
5. Able to complete a coronary artery calcium score test (CAC)
6. Willing and able to consent
7. Willing to have a UH provider and UH care
8. Currently insured for standard of care procedures

Exclusion Criteria:

1. Established documented cardiovascular disease (coronary artery disease, peripheral artery disease, myocardial infarction, stroke).
2. Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg
3. Lung disease requiring supplemental oxygen therapy
4. Individuals receiving treatment for cancer related disease
5. Pregnant or nursing mothers
Aspirin Use and Postoperative Bleeding From Dental Extractions in a Healthy Population

The purpose of this study is to determine if aspirin is associated with bleeding complications following a single tooth extraction

Aspirin is a common chronically administered preventive treatment for cardiovascular disease, but is often discontinued prior to invasive dental procedures because of concern of bleeding complications. As the goal of aspirin is often to prevent MI and stroke, the risk of these CVD outcomes with discontinuation of aspirin must be weighed against the perceived adverse event of bleeding during or following an invasive dental procedure with continuation of aspirin. The current study is a randomized controlled trial evaluating bleeding complications of aspirin vs. placebo in healthy patients schedule for a single tooth extraction.

Eligibility Criteria:
Inclusion Criteria:

* Healthy
* Require a simple tooth extraction

Exclusion Criteria:

* Use of previous aspirin or NSAID
ENdometrial Cancer SURvivors' Follow-up carE (ENSURE): Less is More?

Background: It has often been hypothesized that the frequency of follow-up for patients with early-stage endometrial cancer could be decreased. However, studies evaluating effects of a reduced follow-up schedule among this patient group are lacking.

Objective: Assess patient satisfaction and cost-effectiveness of a less frequent follow-up schedule compared to the schedule according to the Dutch guideline.

Study design: Dutch multicentre randomized controlled trial with a 5 year follow-up. Patients (n=282) are randomized in an intervention group with 4 follow-up visits during 3 years, and a control group with 10-13 follow-up visits during 5 years, according to the Dutch guideline. Patients are asked to fill out a questionnaire at baseline, 6, 12, 36 and 60 months. Patient inclusion will take two years (if 60% of the patients participate).

Outcomes: Primary: Patient satisfaction with follow-up care and cost-effectiveness.

Secondary: health care use, adherence to schedule, health-related quality of life, fear of recurrence, anxiety and depression, information provision, recurrence, survival

Patients: Stage 1A and 1B low-risk endometrial cancer patients, for whom adjuvant radiotherapy is not indicated

Statistics: linear regression analyses to assess differences in patient satisfaction with follow-up care between intervention and control group adjusted for potential pre-defined confounders.

Expected results: Patients in the intervention arm have a similar satisfaction with follow-up care and overall outcomes, but lower health care use and costs than patients in the control arm. No effects are expected on QALY differences (losses) and satisfaction, but the reduced schedule is expected to save 144.000 per year in the Netherlands.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with Endometrioïd type endometrial carcinoma with stage 1 (FIGO, 2009) disease, with the following combination of stage, age and grade:

   Stage 1A, any age, grade 1 or 2; Stage 1B, \< 60 years, grade 1 or 2 without LVSI;
2. Written informed consent;
3. Sufficient oral and written command of the Dutch language.

Exclusion Criteria:

1. Any other stage and type of endometrial carcinoma
2. Histological types papillary serous carcinoma or clear cell carcinoma
3. Uterine sarcoma (including carcinosarcoma)
4. Radiotherapy for current endometrial carcinoma
5. Previous malignancy (except for non-melanomatous skin cancer) \< 5 yrs
6. Confirmed Lynch syndrome
7. Previous pelvic radiotherapy
Implantation of an Advanced Practice Nurse in the Complex Care Pathway of Patients With AML

Advanced Practice Nurse (APN) is a new contributor in the French healthcare system. APN is part of a multidisciplinary team and aim to monitor patients under the coordination of the doctor particularly in onco-hematology. The aim of the study is to describe the different perceptions and expectations of APN monitoring according to patients with acute myeloid leukemia (AML) and their care team.

This study will involve 10 patients, recruited over a provisional period of 5 months and 25 member of care team. Patients and their care team will be asked about their perceptions and expectations of APN participation in (AML monitoring) during a semi-structured interviews.


Eligibility Criteria:
Inclusion Criteria:

* Patient with AML
* Treated with a new targeted oral therapy as monotherapy or in combination:

  * Venetoclax\* in combination with ivosidenib (IDH1 inhibitor)
  * Onureg\* (azacitin: pyrimidine analogue)
  * Venetoclax (BCL-2 protein inhibitor) in combination with subcutaneous azacitin
* Whose follow-up is provided alternately by a hematologist and an IPA.
* Affiliated to a social security scheme

Exclusion Criteria:

* Moderate or severe cognitive impairment
* Language barrier
* Other communication disorders
Phase II Trial of CHOP-R Followed by Zevalin and Rituxan in Follicular Lymphoma

The purpose of this study is to determine the complete response rate when CHOP-R chemotherapy in followed by Zevalin in previous untreated patients with follicular lymphoma

Patients with follicular lymphoma who require therapy and have been previously untreated are eligible for this non-randomized, phase II study evaluating up front therapy with CHOP-R x 3 cycles followed by zevalin and 4 additional weeks of rituxan.The complete response will be determined by combining IWC criteria and PET scanning.Secondary objectives include PET-CT conversion rate, frequency and severity of adverse events, duration of complete remission and time to next lymphoma therapy.

Eligibility Criteria:
Inclusion Criteria:

* Conformed diagnosis of follicular lymphoma, grades 1,2 or 3
* No prior chemotherapy
* No prior monoclonal antibody therapy
* Bulky or symptomatic disease, stage II-IV
* Performance status 0-2

Exclusion Criteria:

* Impaired bone marrow reserve
* Presence of CNS lymphoma
* Serious nonmalignant disease or active infection