cyrilzakka/clinical-trials huggingface dataset:
A Case Control Study to Evaluate the Cognitive and Brain Function of β-thalassemia Patients.

β-thalassemia syndromes are a group of hereditary disorders characterized by a genetic deficiency in the synthesis of beta-globin chains.

In recent studies done in β-thalassemia major patients abnormal iron deposition was evident using MRI in brain structures, cortex, putamen, and caudate nucleus . In most of the cases the neurological involvement is subclinical. Cognitive functioning was evaluated in beta thalassemia major, compared with healthy controls, using a neuropsychological battery including tests of abstract reasoning, attention, executive functions, language, constructional/visuospatial skills, and memory. Patients with beta thalassemia major, in particular those showing signs of hemosiderosis, had significantly impaired function in all neuropsychological tests. There was no relationship between cognitive performances and signs of deferoxamine toxicity, deferoxamine dosage, and levels of hemoglobin and ferritin. Event-related potentials (ERPs) are one of the most informative and dynamic methods of monitoring the information stream in the living brain. ERPs are linked in time with a physical or mental event, and are typically extracted from the scalp-recorded electroencephalogram (EEG) by means of signal averaging.

ERPs have been used in the assessment of cognitive function in several disorders, including anemia and iron deficiency anemia. However, literature regarding cognitive function and ERP activity in thalassemia patients is extremely limited, especially in adults.

The purpose of this study is to evaluate the cognitive and brain function in a group of 60 thalassemia patients and compare the results to healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* Thalassemia major and intermedia patients older than 6 years treated at Emek Medical Center Afula Israel.
* healthy controls matched for age and ethnicity.

Exclusion Criteria:

* patients suffering from acute diseases.
DREAM Project Community Health Worker Intervention

The DREAM (Diabetes Research, Education, and Action for Minorities) Project is a Community Health Worker (CHW) intervention to improve diabetic management and control among Bangladeshis with diabetes in New York City (NYC).

The DREAM (Diabetes Research, Education, and Action for Minorities) Project is a Community Health Worker (CHW) intervention to improve diabetic management and control among Bangladeshis with diabetes in New York City (NYC). For a two-arm, randomized controlled trial (RCT), investigators will recruit a sample of 256 participants, all of whom are 1) of Bangladeshi descent, 2) residing in NYC, 3) diagnosed with Type 2 diabetes mellitus (T2DM) and a recent Hemoglobin A1c (HbA1c) of ≥ 6.5, and 4) between the ages of 21-85. The treatment group receives a six-month CHW-led intervention consisting of five monthly group educational sessions, two one-on-one visits, and follow-up phone calls as needed from a CHW. The control group receives an introductory educational session only. Primary and secondary outcomes include clinical and behavioral measures, such as HbA1c and weight change, access to and utilization of care (i.e. appointment keeping and use of specialty care), and knowledge and practice of physical activity and healthful eating. Additionally, information regarding CHW characteristics, the processes and mechanisms for influencing healthful behavior change, and fidelity of the intervention are collected. Outcomes are measured at Baseline, 3-Months, 6-Months for both groups, and at 12-Months for the treatment group.

Eligibility Criteria:
Inclusion Criteria:

* confirmed clinical diagnosis of T2DM with a Hemoglobin A1c (HbA1c) of ≥ 6.5%; and
* male or female between the ages of 21-85 years old; and
* willingness to be randomized to either treatment or control groups.

Exclusion Criteria:

* is or was on renal dialysis;
* experiencing an acute or terminal illness or serious mental illness;
* had a history of recent coronary event within the last 3 months of recruitment;
* is pregnant at the time of recruitment;
* experienced other severe medical conditions that might preclude participation;
* has poor short-term prognosis (expected death in \<2 years); or
* is participating in another research study.
A Study to Compare the Pharmacokinetics of Lafutidine and Irsogladine Maleate Tablet

An Open-Label, Randomized, Single-dose, 2x2 Crossover Study to Compare the Pharmacokinetics of BRI-1501 Tablet and Coadministration of Lafutidine and Irsogladine maleate as Individual Tablets in Healthy Adult Volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy subject, aged 19- 50 years

Exclusion Criteria:

* History of clinically significant and active disease
* History of gastrointestinal disease
* History of clinically significant hypersensitivity to study drug, any other drug
* Laboratory test serum AST or ALT \> 1.25 times of upper normal range serum total bilirubin \> 1.5 times of upper normal range eGFR \< 60 ml/min/1.73m² serological test(HBsAg, HCV Ab, HIV Ag/Ab, Syphilis reagin) positive
* Hypotension or hypertension
* Pregnant or nursing women
* Participation in any other study within 90 days
A Trial of Tisotumab Vedotin in Cervical Cancer

A Single arm, Multicenter, International Trial of Tisotumab Vedotin (HuMax®-TF-ADC) in Previously Treated, Recurrent or Metastatic Cervical Cancer.

The purpose of the trial is to evaluate the efficacy and safety/tolerability of tisotumab vedotin in patients with previously treated, recurrent or metastatic cervical cancer. Tisotumab vedotin is an antibody-drug conjugate (ADC) targeting tissue factor (TF), a protein aberrantly expressed in a wide number of tumors including cervical cancer. Preliminary safety and efficacy data observed in a cohort of previously treated cervical cancer patients suggest a positive benefit risk profile for this population of high unmet need.

Eligibility Criteria:
Inclusion Criteria

* Patients with extra-pelvic metastatic or recurrent cervical cancer including squamous cell, adenocarcinoma or adenosquamous histology who have experienced disease progressed on standard of care chemotherapy in combination with bevacizumab, if eligible.
* Measurable disease according to RECIST v1.1 as assessed by IRC.
* Age ≥ 18 years.
* Acceptable renal function
* Acceptable liver function
* Acceptable hematological status
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* A negative serum pregnancy test for patients of reproductive potential.
* All patients must provide a fresh or archival biopsy during screening.
* Following receipt of verbal and written information about the trial, patients must provide signed informed consent before any trial-related activity is carried out.

Exclusion Criteria

* Have received no more than 2 prior systemic treatment regimens for recurrent or metastatic cervical cancer.
* Known past or current coagulation defects leading to an increased risk of bleeding;
* Ongoing major bleeding
* Active ocular surface disease
* Known past or current malignancy other than the inclusion diagnosis.
* Peripheral neuropathy grade ≥ 2
Genetic Mutational Analysis of Saliva or Buccal Mucosa Samples From Patients With Embryonal or Alveolar Rhabdomyosarcoma

This research trial studies genetic mutations in saliva or buccal mucosa samples from patients with embryonal or alveolar rhabdomyosarcoma. Identifying gene mutations may help doctors learn about the prognosis of patients with embryonal or alveolar rhabdomyosarcoma.

PRIMARY OBJECTIVES:

I. To identify novel recurrent de novo germline mutations among rhabdomyosarcoma (RMS) case-parent trios.

II. To identify the frequency of de novo germline mutations in cancer predisposition genes among RMS case-parent trios.

SECONDARY OBJECTIVES:

I. To conduct ?deep phenotyping? of children diagnosed with RMS utilizing questionnaire data and information from medical records.

OUTLINE:

Patients and their parents undergo collection of saliva or buccal mucosa samples for genetic mutational analysis. Germline deoxyribonucleic acid (DNA) from saliva or buccal mucosa is evaluated via whole exome sequencing.

Eligibility Criteria:
Inclusion Criteria:

* The patient must be enrolled on ACCRN07 and/or APEC14B1 and registered with COG by a North American member institution
* The patient must have a diagnosis of embryonal rhabdomyosarcoma or alveolar rhabdomyosarcoma
* The patient must be diagnosed with rhabdomyosarcoma between January 1, 2012 and November 30, 2019
* Concomitant treatment on a therapeutic trial is not required
* The patient must have at least one biological parent alive and willing to participate
* All questionnaire respondents must understand English or Spanish
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
XH001 Combination With Immunocheckpoint Inhibitor and Chemotherapy for Patients With Resected Pancreatic Cancer

This is a single-center, open label, single-arm, investigator-initiated study to evaluate the efficacy and safety of XH001 (neoantigen cancer vaccine) sequential combination with immunocheckpoint inhibitor and chemotherapy in pancreatic cancer patients following surgical resection.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form;
* Aged 18 to 75 years old;
* Histologically or cytologically confirmed diagnosis of pancreatic adenocarcinoma;
* Completed an R0 or R1 surgical resection as determined by pathology；
* Have not received any prior neoadjuvant therapy;
* ECOG score is 0 or 1;
* Life expectancy of greater than 12 months;
* CA19-9 \<100U/mL before initial chemotherapy;
* Patients must have adequate organ and marrow function defined by study-specified laboratory tests prior to initial study drug.
* Woman of childbearing potential must have a negative pregnancy test and follow contraceptive guidelines as defined per protocol.

Exclusion Criteria:

* Borderline resectable pancreatic cancer;
* Evidence of disease recurrence or metastasis following surgical resection at any time;
* Evidence of malignant ascites;
* Pre-existing inflammatory bowel disease or the presence of complete or partial bowel obstruction, or persistent severe diarrhea after surgery;
* Needs to receive long-term systemic anti-allergic drug or known hypersensitivity to any component of the study treatment;
* History of autoimmune disease;
* New cerebrovascular accident (including ischemic stroke, hemorrhagic stroke, and transient ischemic attack) within 6 months before screening;
* Acute myocardial infarction within 6 months before screening, or uncontrolled angina, uncontrolled arrhythmia, severe heart failure (see Appendix 3, New York Heart Association Heart Failure Classification Criteria NYHA Class ≥ III) and other cardiovascular diseases;
* Received immunomodulatory medications within 4 weeks prior to the date of the first dose (D1) of XH001, including but not limited to: IL-2, CTLA-4 inhibitors, CD40 agonists, CD137 agonists, IFN-α;
* Received blood transfusion, erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) within 7 days prior to the first dose of XH001;
* Received therapeutic tumor vaccines;
* With congenital or acquired immunodeficiency;
* Participating in other clinical trials and not enrolled at the screening period;
* Unable or unwilling to comply with the study protocol due to potential health, mental or social conditions in the opinion of the investigator;
* Other conditions that, in the opinion of the investigator, would make participation in this study inappropriate.
Effect of Cognitive Stimulating Interventions on Cognitive Self-Efficacy and Sense of Happiness Among Older Adults

The present study aims to determine the effect of cognitive stimulation interventions on cognitive self-efficacy and sense of happiness among older adults.

Research hypothesis:

Older adults who receive the cognitive stimulation interventions exhibit higher cognitive self-efficacy and sense of happiness than those who do not receive it.

A convenient sample of eighty (80) older adults will be used according Epi info V 7.0 program calculation based on the following statistical parameters ; Population size: 250, expected frequency: 50%, confidence coefficient: 95%, acceptable error: 10%, minimum sample size = 70.

The study will include eighty (80) older adults aged 60 years and more and fulfilling the following criteria:

Inclusion criteria

1. Aged 60 years and old.
2. Able to read and write.
3. Have mild cognitive impairment: score of score of 18-23 based on the Mini Mental State Examination Scale (MMSE).
4. Have no depression: score of 0 to 4 using the Geriatric Depression Scale Short Form (GDS_SF).
5. Accept participation in the study. 6. Available at the selected setting during the time of data collection. 7. Have no pronounced impairment of their visual and auditory abilities could affect their participation in the group and make use of most of the materials in the sessions, as determined by the researchers.

The selected study subjects (80) will be randomly assigned to two equal groups of 40 older adults each as flows; Group 1, study group: include older adults who will receive the proposed interventions, cognitive stimulation interventions.

Group 2, control group: include older adults who will receive the routine activities of the elderly club.

Eligibility Criteria:
Inclusion Criteria:1. Aged 60 years and old. 2. Able to read and write. 3. Have mild cognitive impairment: score of score of 18-23 based on the Mini Mental State Examination Scale (MMSE).

4. Have no depression: score of 0 to 4 using the Geriatric Depression Scale Short Form (GDS_SF).

5. Accept participation in the study. 6. Available at the selected setting during the time of data collection.

Exclusion Criteria:

* 7. Have pronounced impairment of their visual and auditory abilities could affect their participation in the group and make use of most of the materials in the sessions, as determined by the researchers.
Effect of Nebulized Milrinone on Right Ventricular Hemodynamics in Adult Cardiac Surgery

The primary aim of this study was to investigate the effect inhaled milrinone given before CPB on improving the right ventricular function measured by transesophageal echocardiography (TEE) at time of CPB separation.

The investigator will include (70) patients planned for elective adult cardiac surgery (Coronary revascularization surgery, Mitral valve surgery, Aortic valve surgery or complex surgery (either two or more valves or valves and coronary revascularization surgery). All surgery should be with CPB. All patients will be diagnosed with preoperative PH. After separation of CPB the patients evaluated as regard the hemodynamics (MAP, HR), the inotropic score as additional intravenous milrinone in the case of low cardiac output or presence of post-CPB PH or RV failure with reduced contractility documented using TEE. Left ventricular EF, and right ventricular hemodynamics represented by RV function measured by (tricuspid annulus plane systolic excursion (TAPSE), fractional area change FAC), and right ventricular systolic pressure by doppler (RVSP) which represent the pulmonary artery pressure all data will be assessed by transesophageal ECHO after anesthesia, immediately before CPB and immediately after separation from CPB all these data will be recorded in the study.

Eligibility Criteria:
Eligibility criteria:

* elective adult cardiac surgery (Coronary revascularization surgery, Mitral valve surgery, Aortic valve surgery or complex surgery (either two or more valves or valves and coronary revascularization surgery).
* All surgery should be with CPB.
* All patients will be diagnosed with preoperative PH. PH was defined as a mean pulmonary artery pressure (MPAP) 30 mmHg or a systolic pulmonary artery pressure (SPAP) 40 mmHg, measured during preoperative right-sided catheterization or estimated by using doppler transthoracic echocardiography.

Exclusion Criteria:

* Cardiac surgery without CPB.
* Hemodynamic instability in the preoperative time (defined as acute requirement for vasoactive support or mechanical device).
* Adult congenital heart disease planned for corrective surgery.
* Contraindication to transesophageal echocardiography (TEE).
* Any surgery involves tricuspid valve annulus as it will compromise the accuracy of RV function assessment by TEE.
The Study of Serum Melatonin Rhythm Levels in Patients With Major Depressive Disorder

One of the main points in the biological trends is, the circadian rhythm and disturbance in this cycle, which cause mood disorders and irregularity in this bio clock, to get depression. The pineal gland with the precise regulation of circadian rhythm of melatonin regulates the brain haemostasis. The abnormal function of this gland gives rise to psychiatric disorders.

In the period of youth and early of middle-age cause biochemical changes and disturbance in biorhythm including melatonin secretion.

This process can change the peak of melatonin phase. In addition, a decrease in the level of serum melatonin, can change the function of immune system of depressed patients. This function facilitates the process of cancerous cell formation and tumor growth.

With respect to the conflicting results and that the positive and negative roles of melatonin in the creation of depression is unknown, the aim of this study was to compare the morning and nocturnal serum melatonin rhythm levels in the patients with Major Depressive Disorder. The second purpose was to measure the morning and nocturnal serum melatonin levels in the depressed and healthy men and women.


Eligibility Criteria:
Inclusion Criteria:

1. age: 22-48 years old
2. gender: male, female
3. who got a depressive score above 20, were included in the depressed group
4. those who obtained a depressive score below 9, were chosen and they were included in the healthy control group.
5. the healthy control group to match to the depressed patients for education, social occasion, occupational and economical situation.
6. the depression disorder was confirmed on the basis of the DSM criteria

Exclusion Criteria:

1. present or past psychiatric
2. physical diagnoses
3. drug consumption
4. use of narcotic substances
5. physical and psychosomatic disorders
6. the stressor
7. malfunction of thyroid gland
8. shift working
Intranasal Dexmedetomidine Versus Oral Paracetamol as a Pre-anaesthetic Medication in Pediatric Age Group

Pre-operative anxiety is a major problem in children because it produces undesired results on induction and postoperative outcome. Dexmedetomidine is a highly specific alpha 2 adrenergic receptor agonist. Studies suggest that Dexmetomidine administration is safe as it is less invasive and have a short half-life.

Paracetamol is a potent physical pain killer. It also reduces psychological reactivity and blunts physical and social pain.

Adenotonsillectomy is one of the most common surgeries performed in pediatric age groups, so it is important to reduce pre-operative anxiety in those children.

Pre-operative anxiety is a major problem in children because it produces undesired results on induction and postoperative outcome. Dexmedetomidine is a highly specific alpha 2 adrenergic receptor agonist. Studies suggest that Dexmetomidine administration is safe as it is less invasive and have a short half-life.

Paracetamol is a potent physical pain killer. It also reduces psychological reactivity and blunts physical and social pain.

Adenotonsillectomy is one of the most common surgeries performed in pediatric age groups, so it is important to reduce pre-operative anxiety in those children.

The objective of this descriptive study is to compare the efficacy of dexmedetomidine and paracetamol premedication, measuring the degree of anxiety in the children prepared for adenotonsillectomy when they are separated from their parents.

Eligibility Criteria:
Inclusion Criteria:

* The patients who are clinically free or with controlled medical condition \[ASA I or ASA II\].
* Age between 2 to 8 years.

Exclusion Criteria:

* ASA III or ASA IV.
* Age greater than 8 years.
* Parents' refusal to participate in the study.
* Patients with obstructive sleep apnea.
* Patients with known allergy or hypersensitivity reaction to any of the drugs used in the study.
* Patients with nasal infection or nasal pathology.
Virtual Reality vs Standard-of-Care for Comfort During Intravenous Catheterization

Children often need an intravenous catheter placement for delivery of fluids and medications, a procedure associated with pain and anxiety. In the Emergency Department topical anesthetics are frequently used.

Virtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain.

This study will randomize children (6 - 16 years old) to receive Virtual Reality or standard of care in addition to topical anaesthetics during IV placement procedure. Investigators will measure pain, anxiety and satisfaction, amount of analgesics used and the level of success in placing the IV and compare between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* Children age 6 - \<17
* The managing physician determines a need for an intravenous catheterization (IV) procedure
* Parents will sign a consent form and children will sign an assent form

Exclusion Criteria:

* Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay, autism, others)
* Triage Category 1 (resuscitation)
* Facial features or injury prohibiting wearing the VR goggles
B-catenin in Cutaneous Squamous Cell Carcinoma and Its Mimickers

Examine the role of B-catenin in differentiation of cutaneous squamous cell carcinoma from other lesions that may be similar to it

Skin cancer is one of the most common form of cancer worldwide. Cutaneous squamous cell carcinoma is one of most common skin tumers that caused by many factors as ultra violet ,ionizing radiation and others . It was an advanced spectrum ranging from actinic keratosis to invasive and metastatic squmous cell carcinoma. Correct identification of cutaneous squamous cell carcinoma is a challenge as it has both clinically and histopathologically mimickers.

So the aim of this study is to identify the expression of B-catenin in cutaneous Squamous cell carcinoma and its mimickers.

Eligibility Criteria:
Inclusion Criteria:

* tissue blocks with sufficient materials Cases with sufficient data

Exclusion Criteria:

* tissue blocks with insufficient and necrotic materials. Casas with insufficient data