cyrilzakka/clinical-trials huggingface dataset:
TCR-T Cells for the Treatment NY-ESO-1-positive Advanced Solid Tumors

New York Esophageal Squamous Cell Carcinoma 1 (NY-ESO-1) is a Cancer-Testis Antigen (CTA) which is expressed in various tumors. After selected the high affinity TCR gene to NY-ESO-1, the researchers insert genes into the cell that expressing a kind of protein that targeting NY-ESO-1. Then the engineered cells are re-infused in the patients with tumors for curing the tumor patient or prolonging life.

This is a single-center, open-label, Phase I clinical study of TCR-T cells for the treatment of the recurrent/metastatic solid tumors patients who had failed standard therapy.

TCR-T cells are expanded from peripheral blood, and after ex vivo modification, and extensive expansion, are reinfused to patients after non-myeloablative lymphocyte-depleting preparative regimen.

The primary purpose of this study is to evaluate the safety and tolerability of TCR-T cells in patients with recurrent/metastatic solid tumors.

The second purpose of this study is to preliminarily explore the effectiveness of TCR-T cells in patients with recurrent/metastatic solid tumors.

Eligibility:

Adults aging 18-70 who were failed to standard treatment or have no standard treatment with recurrent/metastatic solid tumors.

Eligibility Criteria:
Inclusion Criteria:

1. Have the willingness to communicate with investigator, be able to understand and follow the trail requirements, and voluntarily to participate in the trail;
2. 18 \~70 years old (gender is not limited;)
3. The expected survival period is at least 3 months;
4. ECOG score of 0-1;
5. Patients with recurrent or metastatic solid tumors confirmed by histopathology;
6. Subjects who failed standard treatment in the past or have no standard treatment currently tor who are judged by the investigator to be unsuitable for current standard treatment for other reasons, and the objective imaging assessment is disease progression;
7. According to RECIST 1.1 standard, there is at least one measurable target lesion for efficacy evaluation;
8. NY-ESO-1 positive;
9. HLA type is HLA-A2 (except HLA-A\*0203);

Exclusion Criteria:

1. Female subjects who are pregnant or breastfeeding, or have a positive blood pregnancy test at baseline;
2. Subjects who have had severe allergic reactions to any drug or its components in this trial in the past;
3. Subjects who have received any investigational drug within 28 days before the infusion of TIL cells, or participated in another clinical study at the same time;
4. Subjects who have other known history of malignant tumors in the past 5 years, except for localized tumors that have been cured, including in situ cervical carcinoma, basal cell carcinoma of the skin, and in situ prostate carcinoma;
5. Patients who have received adoptive cell therapy in the past;
6. According to the judgment of the investigator, the condition of the subject is not suitable for this trial.
Anemia in Patients With a Non-Myeloid Malignancy

Chemotherapy can often cause anemia in patients with cancer. Anemia is a low number of red blood cells. The symptoms of anemia may include fatigue, dizziness, headache, chest pain, and shortness of breath. Erythropoietin is a hormone made by the kidneys that signals the bone marrow to produce more red blood cells. Recombinant human erythropoietin has been produced in the laboratory and has the same effect as the hormone produced by the body. Use of recombinant human erythropoietin allows the body to produce more red blood cells, possibly eliminating or decreasing your symptoms and the need for a red blood cell transfusion. Recombinant human erythropoietin is FDA approved to treat anemia in cancer patients receiving chemotherapy. This clinical study is investigating the effectiveness of darbepoetin alfa for the treatment of anemia in patients with non-myeloid malignancies who are receiving multicycle chemotherapy. Darbepoetin alfa is a recombinant erythropoietic protein that stimulates the production of red blood cells. This medication has not been approved to treat cancer patients with anemia, however it has been approved by the FDA to treat chronic renal failure patients with anemia.


Eligibility Criteria:
Inclusion Criteria:

* Men or women of legal age, diagnosed with a non-myeloid malignancy and scheduled to receive at least 12 additional weeks of cyclic cytotoxic chemotherapy from the time of first dose of study drug
* Screening hemoglobin concentration less than or equal to 11.0 g/dL
* ECOG performance status of 0 to 2 (inclusive)

Exclusion Criteria:

* History of seizure disorder
* Primary hematologic disorder that could cause anemia
* Unstable or uncontrolled disease/condition related to or affecting cardiac function
* Clinical evidence of chronic infection/inflammatory disease
* Positive test for HIV infection
* Previously confirmed neutralizing antibodies to rHuEPO
* Received rHuEPO or darbepoetin alfa therapy within 4 weeks of study day 1 or more than 2 RBC transfusion occurences
Perminova Respiratory Effort Accuracy Validation 09-12-2013-Rev 2

The purpose of this study is to validate the accuracy of the Perminova N4 Monitoring system Respiration Rate technology.

After IRB Approval, eighteen volunteer test subjects will be entered into an accuracy study that is designed to validate accuracy of the respiratory rate technology of the Perminova N4 Monitoring system (Device Under Test). The subjects will be selected to represent a range of body types including small, average, muscular, and large with a range of BMI's.

A range of stable respiratory rates will be elicited from each volunteer test subject. The rates will be approximately 5, 10, 15, 20, 25, 30, 35 and 40 breaths per minute; with some natural variation from these exact numbers.

Each subject will be instrumented with an open system mask that allows for measurement of the end tidal carbon dioxide (EtCO2) respiratory rate and tidal volume. The EtCO2 monitor will be used as the Accuracy Reference Device (Reference) in this study. Performance of the currently released ECG Impedance Respiratory Rate monitor (Acceptance Standard) will be used to establish the acceptance criteria in this study by comparing to Reference.

Eligibility Criteria:
Inclusion Criteria:

* male
* female
* 18-45
* range of physiques
* healthy

Exclusion Criteria:

* injury to sensor area
* skin inflammation
* implanted devices such as pacemakers
* pregnant
Isolation and Characterization of Blastocystis Hominis as Apotential Human Pathogen

* Detection of the presence of Blastocystis hominis among outpatients presented with GIT symptoms at Assiut University Hospitals in comparison with those in control group.
* Assessment of different culture techniques for detection, and isolation of Blastocystis hominis.
* Molecular identification of Blastocystis hominis using polymerase chain reaction (PCR).

Blastocystis is a genus of single-celled parasites belonging to a group of organisms that are known as the Stramenopiles . Blastocystis consists of several species, living in the gastrointestinal tracts of humans and farm animals. Many different species can infect humans and would be identified as Blastocystis hominis depending on the sequencing of the gene encoding the 18S rRNA . Among the subtypes recognized, ST1-8 could colonize humans as well as animals.

Infection with B. hominis has a worldwide distribution with infection rate reaches up to 60% in developing countries. Initially B.hominis was accepted as a harmless commensal in the intestinal tract, but recently it was implicated as a pathogen. As it able to produce a cysteine protease which breaks up the mucosal IgA antibody. B.hominis infection has been associated with several gastrointestinal symptoms, Even though most cases are asymptomatic, it is also play a significant role in some chronic gastrointestinal illnesses as irritable bowel syndrome (IBS).

Blastocystis spp. are polymorphic parasites with multiple morphological forms including vacuolar, multivacuolar, granular, ameboid, and cystic forms. At least two out of three infections may be missed during microscopic detection of B.hominis due to their polymorphic nature, and the possibility of confusion with yeast, Cyclospora spp. or fat globules. . Different studies suggested that it multiply rapidly in culture medium and considered it a sensitive method for diagnosis of B.hominis . Recently Molecular diagnosis by polymerase chain reaction (PCR) is considered the most sensitive method for the detection of B.hominis.

Eligibility Criteria:
Inclusion Criteria:

* The persons selected for the study are those who are:

  1. Suffering from any GIT manifestations, attending outpatient clinics of Internal Medicine and Tropical Medicine Departments at Assiut University Hospitals (case group)
  2. clinically free persons undergo routine stool analysis for any reasons other than GIT complaint.(control group)

Exclusion Criteria:

* We will exclude any patient who received antibiotic or anti-parasitic drugs the past 4 weeks prior to sample collection.
Esketamine and Perioperative Depressive Symptoms

Perioperative depressive symptoms (PDS) are common in population undergoing surgery, and this would be sharpened especially for complicated, high-risk major surgery. However, None of treatments could resolve this clinical problem during limited perioperative period. The remarkable effects of ketamine on treatment resistant depression have been verified by several clinical trials and the enantiomer S-ketamine (esketamine) showed similar antidepressant efficacy with better safety in recent studies. The efficacy and safety of esketamine administrated intra-operatively for PDS will be verified in this study. Other secondary outcomes such as anxiety, postoperative pain and psychiatric symptoms will also be investigated.


Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing elective major surgery
* Ages between 18 and 65 years old
* Moderate to severe depressive symptoms ( the Patient Health Questionnaire-9 scores equal to or more than 10 and Montgomery-Åsberg Depression Rating Scale scores equal to or more than 22 )
* Signed informed consent

Exclusion Criteria:

* Patients combined with aphasia or other conditions leads that patients inability to cooperate with the metal assessments;
* Tumor related injury of the 9th, 10th, 11th, 12th cranial nerve or patients need keeping intubation after surgery;
* Medical history of psychotic or bipolar disorder;
* Laboratory evidence of hormone levels disorder due to primary diseases;
* Body Mass Index more than 30 kg/㎡;
* Child-Pugh grade B or C;
* Major depressive disorder with antidepressant therapy in the past 2 weeks before screening;
* History of adverse events to ketamine or esketamine;
* Patients with repeated suicide attempts (QIDS-SR 12-item more than or equal to 3);
* History of drug abused;
* Pregnant or breastfeeding woman.
A Study to Learn About How Itraconazole Affects the Blood Level of Study Medicine (PF-07817883) in Healthy Adults.

The purpose of this study is to learn how Itraconazole affects the blood level of PF-07817883 in Healthy Adults.

This study is seeking participants who are:

* male and female aged 18 to 65 years old,
* overtly healthy. This can be determined my medical evaluation, medical history, lab tests etc.

This study will consist of 2 parts, Period 1 and Period 2.

Period 1: participants will take PF-07817883 one time by mouth at the study clinic.

Period 2: participants will take PF-07817883 one time by mouth at the study clinic. They will also take daily itraconazole by mouth for 7 days.

Participants will stay at the study clinic for 2 weeks in total. The study doctors will collect blood and urine samples from everyone. The study doctors will check participants' reactions to the study medicine for safety measures. There is a follow-up call at 28 to 35 days from the last dose of PF-07817883.

Itraconazole is an approved medicine. It is also a metabolism inhibitor. When taken with some medicines, it affects the actual level of these medicines in the body. This study will compare blood levels of PF-07817883 given with and without Itraconazole. This will help decide safety and right amount for PF-07817883 when given with metabolism inhibitors.

This is a Phase 1, open-label, 2-period, fixed sequence study to estimate the effect of itraconazole, a strong CYP3A4 inhibitor, on the plasma PK of PF-07817883 in healthy adults. The study will consist of 2 treatments: a single oral dose of PF-07817883 alone and a single oral dose of PF-07817883 in combination with multiple oral doses of itraconazole. The PK and safety will be assessed and compared for single dose of PF-07817883 in period 1 and period 2.

Eligibility Criteria:
Inclusion Criteria:

* Male and female participants aged 18 to 65 years of age, inclusive, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and standard 12-lead ECG.
* BMI of 17.5 to 32 kg/m2; and a total body weight \>50 kg (110 lb).
* Capable of giving signed informed consent.

Exclusion Criteria:

* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, CV, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing) and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
* Positive test result for SARS-CoV-2 infection at admission.
Study to Investigate Dosage, Efficacy, and Safety of Fycompa in Routine Clinical Care of Patients With Epilepsy

This study is conducted to assess the retention rate of Fycompa when given in routine clinical care.


Eligibility Criteria:
Inclusion Criteria:

* Participants must have met all of the following criteria to be included in this study:

  1. Diagnosis of epilepsy
  2. Initiated treatment with Fycompa at any time after 01 Jan 2014
  3. Provided written informed consent by the participant or the participant's legally authorized representative signed for the use of medical records (if required by an Institutional Review Board \[IRB\] or Independent Ethics Committee \[IEC\], or by regulatory authorities).

Exclusion Criteria:

* Not applicable
The Effect of Probiotic Supported Yogurt Consumption on Gastrointestinal Symptoms

Probiotics have beneficial effect on Gastrointestinal Symptoms. The aim of this study is to determine the effect of probiotic yogurt consumptions on the people who have gastrointestinal symptoms mainly constipation.

In the beginning of the study Constipation Severity Scale and Bristol Stool Scale was applied to the all people who accepted to participate in this study. According to the student T test analysis (α= 0.05, β=0.20 ) 102 people with gastrointestinal symtoms should be included in the study. When 102 people are found with gastrointestinal symptoms second stage of the study will begin. In this stage of the study 102 people are randomly divided into 2 homogeneous groups. 3 day food record will be taken from 102 people at the beginning and again at the end of the study. Probiotic yogurt (Activia Probiotic Yogurt without any aroma-125 g) will be given to one group for 1 month and nothing will be given to the other group (control group).

Eligibility Criteria:
Inclusion Criteria:

* Living in Izmir
* Individuals who are having BMI between 18.5-24.9 kg / m2
* Having gastrointestinal symptoms according to Constipation Severity Scale and Bristol Stool Scale

Exclusion Criteria:

* Having diagnosed gastrointestinal disease
* Regular consumption of probiotic
* Using of drug that affects gastrointestinal system
* Presence of mental illness
Cellular precOnditioning for Post-Surgical Myocardial Ischemic Complications - Observational Study

The goal of this observational study is to collect health data on people who are at high risk of having heart complications and are having a surgery that is not on the heart. The main questions it aims to answer are:

* Is this study feasible in terms of recruiting enough people to participate in this study?
* How often do heart complications happen in people who are at high risk of heart complications and are having a surgery that is not on the heart?

Participants will have their usual care and will also be asked to:

* Have extra bloodwork done
* Complete some surveys
* Have two echocardiograms (ultrasounds of the heart)
* Continue to follow-up with the research team for one year after their surgery

Researchers will compare how often heart complications occur in this high risk population to a future study where participants will receive stem cells before their surgery.

This observational trial protocol is to collect baseline health data from participants undergoing intermediate to high-risk surgery and at high risk of developing perioperative myocardial ischemic complications for an upcoming Phase 1 trial that determines the feasibility of intravenous delivery of umbilical cord-derived (UC) mesenchymal stromal cells (MSCs) in the same patient population. Participants enrolled in this protocol, however, will not receive cell product; they will receive standard of care and serve as a lead in control group for the interventional study.

Eligibility Criteria:
Inclusion Criteria:

A participant must meet all 5 inclusion criteria to be eligible:

* Referred for elective intermediate to high risk noncardiac surgery as defined by the American Heart Association guidelines (e.g., intrathoracic, open intraabdominal, or open vascular surgery)
* 45 years of age or older
* Revised cardiac risk index ≥ 2
* NT-proBNP level of ≥ 200 pg/mL
* Able to provide informed consent

Exclusion Criteria:

* Experience an acute coronary syndrome, myocardial infarction, heart failure, or stroke within preceding 3 months
* Coronary revascularization anticipated during the study period
* Severe mitral/aortic valve stenosis
* Evidence of clinically significant arrhythmia in last three months.
* Major surgical procedure in previous 3 months
* History of malignancy requiring surgery, chemotherapy, immunotherapy, or radiation within previous 5 years
* Ongoing malignancy requiring surgical resection
* Women who are pregnant, breastfeeding, or of childbearing potential who are unable to use a medically acceptable form of contraception throughout the study
* Received any experimental cell therapy previously
* Unable to provide written informed consent
Objective, Passive Assessment of LRRK2 Carriers

The goal of this project is to identify objective, sensitive, and convenient measures for assessing early signs of Parkinson's disease in an at-risk population at home. We will do so by using a wireless sensor and analyzing the radio signals that bounce off patients' bodies, while patients go about their normal life without needing to wear sensors, answer questionnaires, or actively perform any tests.


Eligibility Criteria:
Inclusion Criteria:

* At least 50 years of age
* Able and willing to provide informed consent
* English fluency
* U.S. resident
* LRRK2 G2019S gene carrier, determined by participation in VALOR-PD
* Mild parkinsonian signs, determined by modified Movement Disorder Society-Unifeid Parkinson's Disease Rating Scale (MDS-UPDRS) score from the most recent VALOR-PD visit
* Have WiFi in their residence
* Access to a smartphone or tablet

Exclusion Criteria:

* Inability to complete study activities, as determined by the study team
* Any medical or psychiatric condition that, in the study team's judgement, would preclude participation
* Self-reported or VALOR-PD investigator determined Parkinson's disease
* Any movement disorder (e.g. essential tremor)
* Currently taking neuroleptics or other drugs known to cause parkinsonism
* Pregnancy
* Non-ambulatory status
* More than one ambulatory pet in the household\*
* More than two individuals in the household (not including participant)\*

  * these criteria can be waived at the discretion of the investigators
Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part B)

This intraoperative study is a prospective study analyzing specimens from fifty subjects. Patients scheduled to undergo breast-conserving surgery will be recruited in accordance with the inclusion and exclusion criteria. The study period per subject is the time it takes to assess the ex vivo breast tissue sample using the study device. Image review will be conducted during surgery and compared to the margin status findings in the post-operative pathology report.


Eligibility Criteria:
Inclusion Criteria:

1. Women 18 years of age or older
2. Signed informed consent form
3. Women who have been histologically diagnosed with carcinoma of the breast prior to surgery
4. Patients planning breast preservation and undergoing lumpectomy (partial mastectomy) procedure

Exclusion Criteria:

1. Multicentric disease (histologically diagnosed cancer in two different quadrants of the breast)
2. Neoadjuvant systemic therapy
3. All T4 tumors
4. Previous radiation in the operated breast
5. Prior surgical procedure in the same quadrant
6. Implants in the operated breast
7. Pregnancy
8. Lactation
9. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study