cyrilzakka/clinical-trials huggingface dataset:
Study of Safety,Efficacy and Pharmacokinetics of CT-1530 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia

This is a phase I study of BTK inhibitor CT-1530 in patients with relapsed or refractory B cell non-Hodgkin lymphoma (B-NHL), chronic lymphocytic leukemia (CLL) or Waldenstrom's macroglobulinemia (WM).

The purpose of the study is to determine the MTD/RP2D of CT-1530, and evaluate its safety and tolerability as monotherapy in subjects with relapsed or refractory B cell non-Hodgkin lymphoma (B-NHL), chronic lymphocytic leukemia (CLL) or Waldenstrom's macroglobulinemia (WM).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of B cell Non-Hodgkin Lymphoma(according to World Health Organization \[WHO\] classification)including Chronic Lymphocytic Leukemia/Small cell Lymphocytic Leukemia (International Workshop),or Waldenstrom's Macroglobulinemia(Second International Workshop).
* Have failed ≥1 previous treatment for B-NHL/CLL/WM, and have relapsed or refractory disease following last prior treatment.
* Eastern Cooperative Oncology Group performance status of ≤ 1 and a life expectancy of at least 3 months.
* Measurable disease as per RECIST v1.1
* Availability of tumor sample
* Adequate hematologic function, as defined by neutrophils ≥ 1.0 x 10\^9/L and platelets ≥ 50 x 10\^9/L; patients with neutrophils \< 1.0 x 10\^9/L due to marrow infiltration are allowed to receive growth factors to bring pre-treatment neutrophils to ≥ 1.0 x 10\^9/L.
* Adequate renal function, as defined by creatinine clearance of ≥ 50 ml/min (as estimated by the Cockcroft-Gault equation or as measured by nuclear medicine scan or 24 hour urine collection).
* Adequate liver function, as defined by AST and ALT ≤ 3 x ULN, and bilirubin ≤ 1.5 x ULN (unless documented Gilbert's syndrome).

Exclusion Criteria:

* Prior allogeneic bone marrow transplant
* Autologous stem cell transplant within 3 months of screening
* Active central nervous system involvement
* Subjects with autoimmune hemolytic anemia or immune thrombocytopenia
* Prior treatment with a Btk inhibitor
* Active uncontrolled infection
* History of malabsorption
* Uncontrolled illness, i.e cardiac, endocrine, respiratory, etc.
* History of myocardial infarction, acute coronary syndromes, coronary angioplasty and/or stenting with in the previous 6 months
* History of another currently active cancer
* History of major surgery within 4 weeks or minor surgery within 1 week
* Other medical or psychiatric illness or organ dysfunction
* HIV positive
* Positive for Hepatitis B surface antigen or Hepatitis C-virus

Other protocol-defined inclusion/exclusion criteria may apply
Evaluation of Clinical and Pathological Characteristics and Routine Treatment of Patients With Prostate Cancer

To evaluate clinical and pathological characteristics and treatment protocol and outcomes of patients with prostate cancer in 2 centers of Asyut from 2013 to 2023

Inclusion criteria :

* Male patient , Age ≥ 40 yo
* Diagnosed as prostate cancer from ( 2013- 2023 ) proved by biopsy in South Egypt Cancer Institute "SECI" \& Asyut clinical oncology department
* Newly diagnosed/ metastatic at presentation
* ECOG 0-4

  • Exclusion criteria:
* Having Other types of malignancy.

Eligibility Criteria:
Inclusion Criteria:

* Male patient , Age ≥ 40 yo
* Diagnosed as prostate cancer from ( 2013- 2023 ) proved by biopsy
* Newly diagnosed/ metastatic at presentation
* ECOG 0-4

Exclusion Criteria:

* Having Other types of malignancy.
Study of HPN536 in Patients With Advanced Cancers Associated With Mesothelin Expression

An open-label, Phase 1/2a study of HPN536 as monotherapy to assess the safety, tolerability and PK in patients with advanced cancers associated with mesothelin expression.(Phase 2 portion of the study was not conducted.)


Eligibility Criteria:
1. One of the following progressive advanced or metastatic cancers:

   1. Epithelial ovarian, fallopian tube, or primary peritoneal cancer that is platinum refractory or platinum resistant
   2. Pancreatic adenocarcinoma that is locally advanced, and now with progressive disease on or after front-line treatment
   3. Malignant mesothelioma with epithelioid histology, pleural or peritoneal
2. For Part 2 only - Measurable disease according to RECIST v1.1 for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer, pancreatic adenocarcinoma, and peritoneal mesothelioma, and mRECIST v1.1 for patients with pleural mesothelioma
3. Available archival tissue sample, or fresh biopsy tissue sample must be obtained prior to enrollment. For Part 2 only- a fresh biopsy tissue sample is required.
4. Adequate bone marrow function, including:

   1. Absolute neutrophil count (ANC) ≥1500/mm3 or ≥1.5 x 109/L
   2. Platelets ≥100,000/mm3 or ≥100 x 109/L
   3. Hemoglobin (Hgb) ≥9 g/dL
5. Adequate renal function, including estimated creatinine clearance ≥30 mL/min
6. Adequate liver function, including:

   1. Total serum bilirubin ≤1.5 x upper limit of normal (ULN) unless the patient has documented Gilbert syndrome in which case the maximum total serum bilirubin should be \<5 mg/dL
   2. Aspartate and alanine transaminase (AST and ALT) ≤2.5 x ULN or AST/ALT ≤5 x ULN for patients with liver metastases
7. Serum albumin ≥30 mg/mL

Key Exclusion Criteria:

1. Brain metastases unless previously treated. Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry, and have no evidence of new or enlarging brain metastases
2. Evidence of retroperitoneal fibrosis, mesothelial surface (pleura, pericardium, peritoneum) thickening of ≥4 mm; significant or increasing pleural/pericardial effusions, ascites or pericarditis at baseline deemed unrelated to the underlying malignancy based on computed tomography (CT), magnetic resonance imaging (MRI), or echocardiogram (ECHO); or prior history of pleurodesis, retroperitoneal fibrosis or mediastinal fibrosis.
3. Previous Grade 3/4 infusion or hypersensitivity reaction (not immunotoxicity) to treatment with another monoclonal antibody.
4. For patients with tumor types other than pleural mesothelioma: Ascites requiring \>1 paracentesis for therapeutic purposes (i.e., not for diagnosis) within 1 month prior to Cycle 1 Day 1.
Study of Eribulin in Combination With Anti-PD-1 Antibody in Patients With Metastatic Triple-Negative Breast Cancer

To evaluate the efficacy of Eribulin in Combination With Anti-PD-1 Antibody in Patients With Metastatic Triple-Negative Breast Cancer.


Eligibility Criteria:
Inclusion Criteria:

1. The patients sign the written informed consent.
2. Women aged 18-75.
3. The pathologic diagnosis of unresectable recurrent or metastatic triple-negative breast cancer ［ER-negative(IHC\<1%), PR-negative(IHC\<1%), HER2-negative（IHC-/+ or IHC++ and FISH/CISH-）］. Patients with at least one measuring lesion that was conformed to RECIST v1.1 standard.
4. PD-1/PD-L1positive or TMB≥5.
5. Prior therapy (adjuvant/neoadjuvant/advanced) must have included an anthracycline and/or a taxane in any combination or order and either in the early or metastatic disease setting unless contraindicated for a given patient.
6. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
7. The results of patient's blood tests are as follows:

   • Hb≥90g/L; • Plt≥100\^9/L; • Serum albumin ≥3g/dL;• Neutrophils≥1.5\^9/L; TSH≤ normal upper limit (ULN);• ALT and AST ≤1.5 ULN (liver metastases ≤3 ULN); • TBIL ≤ULN (total bilirubin ≤1.5 ULN in Gilbert's syndrome or liver metastasis subjects);• ALT and AST ≤1.5 ULN (liver metastases ≤3 ULN);• AKP≤ 2.5 ULN; • Renal function within 7 days before the first administration: serum creatinine ≤1.5 ULN or creatinine clearance ≥60mL/min
8. Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose and must be willing to use very efficient barrier methods of contraception for the course of the study through 6 months after the last dose of study treatment.

Exclusion Criteria:

1. The subjects had a central nervous system metastases with clinical symptoms.
2. Subjects with treatment history of PD-1 / PD-L1 inhibitors;
3. Peripheral neuropathy ≥ grade 2; Cardiac dysfunction, hyperthyroidism or hypothyroidism, type 1 diabetes, active hepatitis and tuberculosis; Autoimmune diseases requiring systemic treatment, and a history of pneumonia (requiring corticosteroid treatment) or interstitial lung disease.
4. Pregnant or lactating women.
5. Other clinical trials of drugs were used in the first four weeks before the first dose.
6. The subjects had any history of autoimmune disease or any use of systemic glucocorticoid or immunosuppressive medications.
7. Hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.).
8. Congenital or acquired immune deficiency (such as HIV infection);
9. Receive live vaccine within 4 weeks before or during the study period;
10. Patients who are allergic to or contraindicated to the experimental drugs.
11. Other malignant tumors in the past, except cervical cancer and non melanoma skin cancer, which have survived for 5 years without disease.
12. Subjects with any other diseases that are unfit for the treatment.
Orgasmic Meditation and Sleep Quality

The primary purpose of this study is to use an observational design to examine whether the practice of orgasmic meditation (OM) is associated with app-based measures of sleep quality. A secondary purpose of this study is to examine whether the occurrence of physiological orgasm during OM practice is associated with app-based measures of sleep quality. It is hypothesized that the practice of OM will have a positive impact on sleep quality.


Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old, males and females, no exclusion by race, ethnicity or sexual orientation
2. Experienced in OM practice ("experienced" defined as \>10 OM sessions in lifetime)
3. Currently practicing OM and participating in ≥1 OM session per week on average
4. Willingness to calibrate the Sleep Cycle app and use it for 30 continuous nights
5. Ability to charge phone by bed overnight during sleep
6. Ability to place phone near the bed, such as on a nightstand table overnight during sleep

Exclusion Criteria:

1. Inability to speak English
Efficacy and Safety Study of Bimatoprost Sustained-Release (SR) in Participants With Open-angle Glaucoma or Ocular Hypertension

This study will evaluate the efficacy and safety of bimatoprost SR in participants with open-angle glaucoma or ocular hypertension. The study includes a 12-month treatment period with an 8-month extended follow-up.


Eligibility Criteria:
Inclusion Criteria:

-Diagnosis of either open-angle glaucoma or ocular hypertension in each eye and both eyes require IOP-lowering treatment.

Exclusion Criteria:

* Previous enrollment in another Allergan Bimatoprost SR Study.
* Eye surgery (including cataract surgery) and/or any eye laser surgery within the past 6 months in the study eye
* Anticipated need for laser eye surgery in either eye within the first 52 weeks of the study duration
* History of glaucoma surgery
Effects of BRACE Protocol on Fall Risk Among Elderly Population

The objective of this study is to compare the effects of Balance Resistance Aerobic Cognitive Exercises (BRACE) and Otago's exercises on fall risk among elderly population. And to determine the effects of BRACE and Otago's exercise on static and Dynamic balance in elderly population. the study will be randomized control trial including experimental and control group with estimated 17 individual in each group. Balance resistance aerobic resistance exercises will be performed by experimental group and Otago's protocol will be performed by control group.

Balance control is the foundation of a person's ability to move and function independently. However, balance control declines with age, and impaired balance is a major risk factor for falls among older adults. Training balance during dual-task conditions appears to be necessary to improve balance control under situations with divided attention.

Balance training program for older adults, including dual- and multi-task exercises, was designed and developed based on well-established principles of exercise and on the knowledge that balance control relies on the interaction of several physiological systems, as well as interaction with environmental factors and the performed task.

Many studies reported that prevention of fall is possible by adopting a healthy lifestyle, environmental modification, exercise and education. Exercise plays a very important role in fall prevention e.g exercise and tai chi training target balance, flexibility and strength can reduce fall and harm related to fall. Although it does not show a marked difference enjoyable exercise program training is beneficial to achieve healthy outcomes.

A new tool has been designed for fall risk reduction and to mobility in elderly is BRACE (Balance, Resistance, Aerobic, Cognition Exercises). Limited work was done on BRACE protocol so in this study we will do further work on this innovative protocol. The aim of our study is to compare the effects of Balance Resistance Aerobic Cognitive Exercises (BRACE) and Otago's exercises on mobility and fall risk reduction in the elderly

Eligibility Criteria:
Inclusion Criteria:

* berg and balance 0-39

MOCA score not less than 22

Exclusion Criteria:

* • Severe cognitive impairment that prevented them from understanding instructions.

  * Serious musculoskeletal, neurological and visual impairment that might affect measurement.
  * Involvement in other exercise programs.
  * Patients have vertebrobasilar insufficiency
  * Atlanto-axial instability
  * Osteoporosis
  * Rheumatoid arthritis
Precise Treatment System of Biliary Malignancies Based on Special Disease Database

Malignant tumors of biliary system lack standard treatment and precise prognosis assessment methods. This study including 12 hospitals, collecting clinical and follow-up data of patients with biliary malignant tumors including cholangiocarcinoma and gallbladder carcinoma in recent 10 years, aim to build a special disease database, then use Bayesian networks and importance theory to establish a mathematical model to assess treatment strategies and prognosis accurately. At the same time, data on biliary malignant tumors newly treated by multicenters from 2018 to 2020 will be included to validate, adjust and refine the models to guide clinical individualized precise treatment.


Eligibility Criteria:
Inclusion Criteria：

* Clinical diagnosis of biliary malignancy including gallbladder carcinoma or cholangiocarcinoma verified by pathological results
* Must be able to undergo surgery
* Undergoing radical surgery for biliary malignancy (R0 or R1 resection)
* Not complicated with other malignancy
* No other treatments before and during surgery, such as radiotherapy and chemotherapy.

Exclusion Criteria:

* Non-primary gallbladder or cholangiocarcinoma
* With distant metastasis (M1 phase)
* Incomplete follow-up data
* Died within 30 days after surgery.
Use of Eye Tracking to Aid in Autism Risk Detection

The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series of eye-tracking measures.

The study will use a non-invasive remote eye-tracking system (Eyelink Portable Duo) to acquire a short series (less than 15 mins) of eye-tracking measures (e.g., looking time, pupil diameter, oculomotor dynamics), which may be associated with autism in young children ages 12-48 months. We will recruit children from Riley Hospital for Children at Indiana University Health clinics to determine whether these measures may help determine autism risk.

Eligibility Criteria:
Inclusion Criteria:

* Young children ages 12-48 months scheduled for health care visits at Riley Hospital for Children at Indiana University Health clinics (e.g., Pediatric Care Center clinics).
* Children must have English- or Spanish-speaking caregivers.
* Children must have a legal guardian that is able to provide consent.

Exclusion Criteria:

* Child is younger than 12 months or older than 48 months.
* Child's caregiver(s) is not English- or Spanish-speaking.
PET / CT With 18F-FDG: Does it Optimize the I 123-MIBG Imaging Results in the Search for Discriminating Factors for the Implementation of an Implantable Defibrillator?

The main objective of this study is to determine among the patients included a subpopulation that does not need a defibrillator.

This will be done by comparing the number of discordant segments (mismatch) between patients who have a severe arrhythmia (ventricular tachycardia or ventricular fibrillation) with appropriate electrical therapy within 3 years of monitoring and others. "Mismatch" in the definition of this objective is the usual definition: score 3.4 in I123-MIBG (Iodine 123 metaiodobenzylguanidine) and PET at 0,1,2.


Eligibility Criteria:
Inclusion Criteria:

* Patient with ischemic heart disease with heart failure
* Patients who received myocardial perfusion scintigraphy
* Indication for the implantation of an ICD installed according to current recommendations : LVEF \<30% and NYHA (New York Heart Association) stage II, III.
* The subject must have given his informed consent and signed consent
* The subject must be a member or beneficiary of a social security system

Exclusion Criteria:

* Pregnant or lactating women
* History of "open heart" cardiovascular surgery
* Inability to sign informed consent (patient under guardianship)
* Patients with diabetes mellitus
* Patient with proven dementia
* Person refusing to sign the consent
* Someone who already has an ICD at baseline
* Life expectancy less than one year (NYHA IV, other diseases such as neoplastic disease in an advanced stage)
COVID-19 : Pulmonary Ultrasound in Primary Care

COVID-19 infection are characterized by fever and signs of acute respiratory infection. A worsening of respiratory symptoms that can lead to respiratory failure. The decompensation can then be brutal and require rapid recourse to respiratory assistance. The contribution of clinical examination (auscultation and monitoring of oxygen saturation in particular) remains unsatisfactory in predicting an unfavorable course. The interest of pulmonary ultrasound is known in the management of pulmonary infections. However, estimating the severity of lung damage at an early stage could be of great help in monitoring and caring for patients. Ultrasound could meet this need in general practice, the chest scanner is often unavailable in these situations.

Ultrasound signs are associated with severe forms. The contribution of pulmonary ultrasound seems particularly interesting in the context of the reassessment of patients during the worsening phase of symptoms (D5-D10).

Estimate the prevalence of ultrasound signs in patients with an acute respiratory infection suspected or confirmed to be COVID-19, at the time of the worsening phase (between D5 and D10 of the onset of symptoms).

The prevalence of ultrasound lung lesions under COVID-19 may be essential to consider the development of the ultrasound tool in primary care. Indeed, if the contribution of ultrasound is now recognized in intensive care or emergency, its place in general medicine still raises questions.


Eligibility Criteria:
Inclusion Criteria:

1. Patients over 18 years of age with :

   * a clinical symptomatology suggesting an acute respiratory infection linked to COVID-19 defined by the following two categories of symptoms:

     * Sudden fever (or a feeling of fever)
     * Respiratory signs (cough, dyspnea, chest tightness) Or
   * an acute respiratory infection confirmed to COVID-19 by the result of RT-PCR screening tests.
2. And presenting, at the time of inclusion between the 5th and 10th day of infection, one of the respiratory signs of severity felt:

   * Dyspnea, shortness of breath or difficulty in breathing
   * Chest pain or tightness

Exclusion Criteria:

1. The presence of a severe form during the initial consultation. A severe form is defined by the presence of the following signs:

   * Polypnea\> 22 / min
   * systolic BP \<90 mmHg
   * Sp02 \<90%
   * Altered consciousness, confusion, drowsiness
   * Dehydration
   * Alteration of the general condition in the elderly
2. The presence of acute respiratory signs clearly having a cause other than a COVID-19 infection.
Point of Care Ultrasound to Confirm Endotracheal Tube Cuff Position in Relationship to the Cricoid in Pediatric Population.

Anatomically, the infra-glottic area (subglottis) and the cricoid ring are the narrowest part of the larynx. In order to limit the incidence of damage related to mucosal pressure injuries from the presence of an endotracheal tube (ETT), the cuff of the ETT should lie below the cricoid in children. Previously, no clinical or imaging method has been used in real time at the bedside to determine the exact location of the ETT cuff after endotracheal intubation. Point-of-care ultrasound (POCUS) may provide an option for a safe and rapid means of visualizing the cuff of the ETT and its relationship to the cricoid ring in real-time thereby allowing ideal ETT positioning.

Airway below vocal cords until the distal end of the cricoid referred to as subglottis or infraglottis is considered to be the narrowest part of the airway. An optimal endotracheal tube (ETT) placement with cuffed ETT is to ensure the cuff position below the cricoid ring (cuff free glottis): as well have sufficient distance between ETT tip and carina. Various modalities including clinical examination, ETCO2, imaging (X-ray and ultrasound) are routinely used to verify the position and the tip of the ETT in the airway, however verification of the cuff position remains obscure.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing general anesthesia requiring endotracheal intubation

Exclusion Criteria:

* Patients with any anatomical airway deformity or mass
Fistulotomy With or Without Marsupialization for Treatment of Simple Anal Fistula

Patients with simple anal fistula will undergo fistulotomy operation and will be divided into two groups: the first will undergo marsupialization of the laid open fistula track and second group will not undergo marsupialization. The effect of marsupialization on healing of anal fistula will be compared postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* Both genders
* Age: 18-65 years
* All Patients with primary simple anal fistula (subcutaneous, intersphincteric, or low trans-sphicnteric involving less than 25% of external anal sphincter fibers).

Exclusion Criteria:

* High trans-sphincteric, extra-sphincteric, supra-sphincteric, secondary.
* Recurrent anal fistulas.
* Patients associated with anorectal pathology such as anal fissure, hemorrhoids, rectal prolapse, neoplasm, solitary rectal ulcer, inflammatory bowel diseases and TB.
* High risk patients according to ASA (American society of anesthesiologists )
* Any degree of incontinence.
* Patients with previous anal surgery.