cyrilzakka/clinical-trials huggingface dataset:
T Cell Receptor Based Therapy of Metastatic Colorectal Cancer

T Cell Receptor Based Therapy of Metastatic Colorectal Cancer With mRNA-engineered T Cells Targeting Transforming Growth Factor Beta Receptor Type II (TGFβII)

Patients with advanced metastatic colorectal cancer who have no other effective treatment options will be offered the treatment. These patients have a poor prognosis, and there is a strong need for improved therapy.

The patients will be given adoptive cell therapy (ACT) with Radium-1 TCR+ T cells transiently redirected against the TGFβRII frameshift antigen which is expressed in MSI+ colon cancer. The first report on TCR therapy in colon cancer was targeting carcinoembryonic antigen (CEA) where some evidence of clinical response was seen, but the T-cell function may have been inhibited due to the necessity to resolve the severe colitis which occurred due to the presence of CEA in normal cells in the colon. This demonstrates the feasibility of T-cell therapy in metastatic colon cancer, but also the limitations of targeting CEA as an antigen.

Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic colon cancer which is MSI+ with the presence of the -1A deletion in TGFβRII gene, and positive for HLA-A02 genotype
* Measurable disease
* Female or male patients. Fertile females must have a negative pregnancy test before inclusion in the trial. Both fertile men and women must be ready and able to use highly effective methods of contraception, defined as use of oral, implanted, injectable, and mechanical or barrier products for the prevention of pregnancy during participation of the trial
* Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1
* Age 18 years and older
* Life expectancy of at least 3 months
* Signed informed consent (by the subject or subject's legal representative) obtained before any trial-related procedures.
* Adequate organ function, measured by pre-defined laboratory values

Exclusion criteria

* Other metastatic malignancies
* Any other anti-tumour treatment within 4 weeks prior to first administration of cells.
* Steroid treatment, except substitution dose
* Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina or serious cardiac arrhythmia
* Active infection requiring antibiotic therapy
* Pregnancy or lactation
* Known hypersensitivity to any of the components of the investigational product
* Patients who test positive for hepatitis B, C, HIV or syphilis
* Any reason why, in the opinion of the investigator, the patient should not participate
txt2protect: Using Text Messaging to Increase HPV Vaccination Among Young Sexual Minority Men

Human Papillomavirus (HPV) is a common sexually transmitted infection that can cause cancer (anal, penile, oropharyngeal) and genital warts in men. Due to their sexual practices (e.g., receptive anal intercourse), men who have sex with men (MSM) are at particularly high risk for HPV infection and are disproportionately affected by HPV-related cancers. A safe and effective vaccine is available to prevent HPV infection, yet HPV vaccination rates in the U.S. have been low, particularly among males. To remedy this gap, the goal of this study is to develop and pilot test a text messaging intervention to increase HPV vaccination in young MSM.

The study has two specific aims:

1. Develop, iteratively refine, and pre-test messages using a formative research procedure for designing targeted health interventions. The procedure consists of the following steps: 1) conduct online focus groups, an online survey, and in-depth interviews to inform message content, 2) draft initial messages based on focus group findings and pilot data, 3) refine message content and assess acceptability using content advisory teams, 4) conduct internal alpha testing to ensure software functionality, and 5) beta test the protocol.
2. Test the feasibility, acceptability, and preliminary efficacy of the txt2protect (t2p) text messaging intervention in a pilot randomized controlled trial (RCT). To achieve this aim, 460 unvaccinated MSM (ages 18-25) who live in the Chicago metro area will be randomly assigned to the treatment (t2p) or control condition. The treatment condition will receive a culturally appropriate text messaging-based HPV vaccination intervention based on the Information, Motivation, and Behavioral Skills model, whereas the control condition will receive a text messaging-based sexual health intervention that includes basic facts about HPV vaccination readily accessible online.

Primary outcome measures include intervention feasibility (e.g., retention in the trial), acceptability (satisfaction with the intervention), and preliminary efficacy as determined by initiation (receipt of the first dose) and completion of the 3-dose HPV vaccine series at the end of the 9-month trial.

The study team hypothesizes that participants in the t2p condition (vs. control) will report greater acceptability of the intervention and will be significantly more likely to initiate and complete the 3-dose HPV vaccine series by the end of the trial.


Eligibility Criteria:
Inclusion Criteria

Participants must:

1. Be male (sex at birth and gender identity)
2. Self-identify as gay, bisexual, or queer; ever had sex with a man; or be physically attracted to men
3. Be English speaking
4. Live in the Chicago metro area
5. Be the exclusive owner of a cell phone
6. Have used text messaging for at least 6 months
7. Plan to have the same cell phone number for the next 9 months
8. Be enrolled in an unlimited text messaging plan

Exclusion Criteria

* Participants must not have been previously vaccinated for HPV.
The Evolutionary Model of Mild-to-moderate Myopia in China

Myopia has emerged as a major health issue in east Asia, because of its increasingly high prevalence in the past few decades (now 80-90% in school-leavers), and because of the sight-threatening pathologies associated with high myopia, which now aff ects 10-20% of those completing secondary schooling in this part of the world. Similar, but less marked, changes are occurring in other parts of the world. The higher prevalence of myopia in east Asian cities seems to be associated with increasing educational pressures, combined with life-style changes, which have reduced the time children spend outside.

Myopia has emerged as a major health issue in east Asia, because of its increasingly high prevalence in the past few decades (now 80-90% in school-leavers), and because of the sight-threatening pathologies associated with high myopia, which now aff ects 10-20% of those completing secondary schooling in this part of the world. Similar, but less marked, changes are occurring in other parts of the world. The higher prevalence of myopia in east Asian cities seems to be associated with increasing educational pressures, combined with life-style changes, which have reduced the time children spend outside.

In this trial, the investigators aim to study the evolutionary model of myopia in China, which could provide new insight into the social development and human adaptation.

Eligibility Criteria:
Inclusion Criteria:

* Patients complete the examination of Refractive error from 2005 to 2015 year.

Exclusion Criteria:

* Patients could not complete the examination of Refractive error
Transcranial Direct Current Stimulation (tDCS) Cost-utility-analysis in Medical Care on Depressive Episode With One Drug Therapy Failure.

The purpose of this study is to determine the transcranial direct current stimulation (tDCS) cost-utility in the depression therapy.

This is a 3 years medico-economics study with 1 year follow-up period involving patients with 1 or 2 depression treatment(s) failed.

Eligible subject will be randomized in 2 groups, usual care with tDCS cure (arm A) or only usual care (arm B).

Transcranial direct current stimulation is a non-invasive brain neuromodulation technique. tDCS can be a new therapy in depression.

This study focuses on tDCS cost-utility-analysis. Each patient is following during 12 months. Patients are randomized in 2 arms. Arm A usual care with tDCS cure or arm B usual care without tDCS.

Patient in arm A get a initial tDCS cure one week after randomization. If these patients are answering to the treatment, they can have a new cure in case of relapse. This new cure can start from the second month following initial treatment.

Eligibility Criteria:
Inclusion Criteria:

* Depression according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) with 1 or 2 failed antidepressant treatments for the current episode.
* MADRS score superior or equal to 15.
* Patient agreeing to participate in the study
* Patient able to answer questionnaires and able to go at research center for follow-up visit.
* Patient with social insurance

Exclusion Criteria:

* Electroconvulsive therapy or repetitive transcranial magnetic stimulation for current depressive episode.
* Depressive episode with psychotic symptoms or mixed.
* Schizophrenia or addiction to another substance than nicotine
* Severe neurological disorder (like epilepsy, neurological affect, neurological disease)
* Severe and / or progressive somatic pathology (leave to the investigator judgment) preventing from participation in the study.
* tDCS specific contraindications (intracerebral metallic implant, pacemaker)
* Pregnancy or breast feeding.
* Woman of childbearing age without contraception (hormonal or with medical device).
* Participation in another interventional clinical trial
* legal protection
* Persons incarcerated or in obligation of treatment / medical treatment order.
Validation of the Sickle Cell Disease Pain Burden Interview

The purpose of this study is to validate a brief survey tool, the SCD Pain Burden Interview (SCPBI), which can be used in the clinical and/or research settings to assess the impact of pain on children with sickle cell disease.


Eligibility Criteria:
Inclusion Criteria:

* Documented sickle cell disease
* 7 years old or greater
* Primary caregiver present at the first visit for children \< 18 years of age

Exclusion Criteria:

* Primary language spoken other than English
* Patient is in acute pain episode at time of initial visit
Simulation-Based Study of Adding Video Communication to Dispatch Instruction

The purpose of this study is to determine whether adding interactive video communication to dispatch instruction improves the quality of bystander cardiopulmonary resuscitation in simulated cardiac arrests.

Sudden cardiac death (SCD) is a leading cause of adult death and bystander cardiopulmonary resuscitation (CPR) significantly improves survival. Dispatch assistance increases the chance of bystander CPR but the quality of dispatcher-assisted CPR (DA-CPR) remains unsatisfactory. This study is conducted to assess the effect of adding interactive video communication to dispatch instruction on the quality of bystander CPR, including chest compressions and rescue breathing, in simulated cardiac arrests.

Eligibility Criteria:
Inclusion Criteria:

* Volunteers above 16 years of age who have not received any CPR training within the last 5 years were recruited.

Exclusion Criteria:

* Healthcare providers, non-Mandarin speaking individuals, and those with illness/physical conditions that prevent them from receiving telephone instructions or performing CPR were excluded.
The Effect of High Dose Vitamin C on the Liver Function in Chronic Hepatitis Patients

The investigators will evaluate the efficacy of high dose vitamin C in chronic hepatitis patients whose serum liver enzymes are elevated more than upper limit.

The changes of laboratory findings including serum transaminase levels, serum albumin levels, Child-Pugh score, MELD score, and APRI score will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Chronic hepatitis C patients

   * positive anti-HCV antibody more than 6 months
   * serum alanine aminotransferase 40 - 80 IU/L for more than 6 months
   * not indicated for antiviral therapy with interferon and ribavirin
2. Chronic alcoholic hepatitis

   * significant alcohol drinking history and no other cause of chronic hepatitis
   * serum alanine aminotransferase 40 - 80 IU/L for more than 6 months

Exclusion Criteria:

* Chronic hepatitis B, autoimmune hepatitis, primary biliary cirrhosis, Wilson's disease, hemochromatosis, other chronic hepatitis except chronic hepatitis C or alcoholic hepatitis
* decompensated liver cirrhosis
* platelet \< 50,000/uL or white blood cell \< 1,500/uL
* need and willing for antiviral therapy
* significant renal dysfunction (GFR \< 30 mL/min/kg) or history of renal stone
* hepatotonic drug (i.e. silymarin, garlic oil, aronamin gold) usage within 2 weeks
* pregnancy, lactating woman
Early Catheter-directed Treatment of High Risk Pulmonary Embolism

Prospective, multicenter, open label, randomized controlled clinical trial to compare the effects of an early catheter-directed treatment plus conventional care with conventional care in patients with high-risk pulmonary embolism


Eligibility Criteria:
Inclusion Criteria:

1. Pulmonary embolism as confirmed by CT angiogram with high mortality risk as defined by ESC guidelines:

   a) One of the following: i. Cardiac arrest or ii. obstructive shock (systolic BP \<90 mmHg or vasopressors required to achieve a BP ≥90 mmHg despite an adequate filling status), in combination with end-organ hypoperfusion (cold, clammy skin, oliguria or serum lactate ≥2 mmol/L) and b) Signs of right-ventricular dysfunction on transthoracic echocardiogram or CT scan
2. Age ≥18 years

Exclusion Criteria:

1. Contraindications for catheter-based treatment
2. Contraindications to systemic fibrinolytic treatment or anticoagulation\*

   1. Active, potentially life-threatening bleeding
   2. Surgery within 24h before screening
   3. Cranial or spinal surgery within 14d before screening
   4. Stroke within 14d before screening
   5. Intracranial tumor
   6. Any condition not listed here but estimated as clinically relevant as judged by the treating investigator
3. Pregnancy

   * Patients with contraindications to systemic fibrinolysis or anticoagulation can be enrolled in a third study arm (registry) and undergo catheter-directed therapy.
Study to Compare the Effect of a Combination of Dipyridamole With Sustained Release and Acetyl Salicylic Acid (Aggrenox®) on the Performance Relevant to Safety and on the General Condition of Healthy Volunteers

Study to investigate whether psychomotor performance which is necessary for safety driving a car or operating machinery and safely participating in daily life is changed by Aggrenox®. Also to investigate whether Aggrenox® impairs performance in combination with alcohol more than alcohol alone. Derived from this: Statement on whether a warning for drivers is necessary


Eligibility Criteria:
Inclusion Criteria:

* Race: Caucasian
* Men and women aged between 40 and 65 years
* Written and spoken command of German
* Ability to understand the nature and significance of the study
* Written informed consent to participate in the study

Exclusion Criteria:

* Acute disease at the beginning of the study
* Any chronic disease in particular:

  * Diseases for which the administration of the test drug was contraindicated:
  * Severe coronary heart disease (e.g. unstable angina pectoris or recent myocardial infarction)
  * Subvalvular aortic stenosis or hemodynamic instability, myocardial decompensation
  * Severe hypotension, hypotonic collapse
  * Any other cardiac disease (or case history of)
  * Chronic obstructive lung disease
  * Hepatic and renal dysfunction
  * Diseases of the gastrointestinal tract
  * Mental or neurologic diseases
  * Alcoholism, alcohol abuse
  * Case history of clinically relevant allergies (particularly against one of the ingredients of the test substance incl. paracetamol)
  * Participation in another clinical study during the last two months preceding the study
* Women while pregnant or breastfeeding
* Women of childbearing age without safe contraception
* Psychotropic drugs during the last four weeks before the beginning of and during the study
* taking other medicaments regularly during the last two weeks before the beginning of and during the study (except for oral contraceptives, hormone replacement in women)
* Body weight outside the Body-Mass-Index (BMI) +- 4
* Habits of life style having a presumable negative effect on the results of the performance test (e.g. shift work, extreme sports, blood donation within the last 4 weeks, \> 8 cups/glasses of caffeine-containing beverages/day, \> 40 g alcohol/day, \>40 cigarettes/day)
* positive or no drug screening for barbiturates, benzodiazepines, tricyclic antidepressants and cannabinoids, amphetamines, cocaine, opiates
* Persons having been detained in an institution by judicial or official order
* Persons incapacitated or placed under provisional guardianship
Observational of PNH Type Cells in Korean Patients With Bone Marrow Failure Syndrome and Having Hemolytic PNH

Patients who are positive of PNH-type cells are followed up for the percentage of PNH-type cells regularly for examining how it change.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Commbs' test - negative
* Any patients meeting any of Idiopathic AA/MDS/Patients who had PNH clone size \<10%

Exclusion Criteria:
Prospective Observational Study Of Patients With Polycythemia Vera In US Clinical Practices (REVEAL)

This is a Phase IV, multicenter, non-interventional, non-randomized, prospective, observational study in an adult population (patients \>18 years old) of men and women who have been diagnosed with clinically overt PV and are being followed in either community or academic medical centers in the United States who will be enrolled over a 12-month period and observed for 36 months from the date the last patient is enrolled.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Diagnosis of Polycythemia Vera (PV)
* Willing and able to provide written informed consent
* Willing and able to complete patient assessment questionnaires either alone or with minimal assistance from a caregiver and/or trained site personnel
* Under the supervision of a physician for the current care of PV including but not limited to watchful waiting, acetylsalicylic acid (ASA) 81mg or greater, antithrombotic therapy, Phlebotomy (PHL), Hydroxyurea (HU), interferon (recombinant or pegylated), busulfan, anagrelide

Exclusion Criteria:

* Participation in an active clinical trial in which the study treatment is blinded
* Life expectancy \<6 months
* Diagnosis of myelofibrosis (MF) \[including primary MF, post-PV MF, or post-essential thrombocythemia MF (post-ET MF)\]
* Diagnosis of secondary Acute Myeloid Leukemia (AML)
* Diagnosis of Myelodysplastic Syndrome (MDS)
* History of or active plan to proceed to allogeneic hematopoietic stem cell transplant in next 3 months
* Splenectomy
A Revised Tafenoquine Dose to Improve Radical Cure for Vivax Malaria

The goal of this clinical trial is to assess the efficacy and safety or a revised weight band tafenoquine dose in vivax malaria patients. The main question\[s\] it aims to answer are:

* is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) non-inferior to high dose primaquine (7mg/kg over 7 days)
* is a revised weight-based TQ regimen (TQRevised: target dose 7.5mg/kg) superior to fixed dose tafenoquine (300mg)
* is the tolerability and safety of TQRevised acceptable
* is TQRevised acceptable and feasible Participants will receive a tafenoquine target dose 7.5mg/kg in weight bands. Researchers will compare this to patients receiving a fixed dose tafenoquine and high dose primaquine to see if safe and effective.


Eligibility Criteria:
Inclusion Criteria:

* P. vivax peripheral parasitaemia (mono-infection)
* G6PD normal status (G6PD activity ≥70% of the adjusted male median as determined by the Standard G6PD (SDBioline, ROK))
* Fever (temperature ≥37.5⁰C) or history of fever in the preceding 48 hours
* Written informed consent
* Living in the study area and willing to be followed for six months

Exclusion Criteria:

* Danger signs or symptoms of severe malaria
* Anaemia (defined as Hb \<8g/dl)
* Pregnant or lactating females
* Regular use of drugs with haemolytic potential
* Known hypersensitivity to any of the study drugs.
The SleepTrackTXT2 Randomized Trial With Air-medical Personnel

The overarching goal of this proposal is to address the MedEvac foundation priority of educational techniques and technologies and improve Helicopter Emergency Medical Services (HEMS) safety by determining if overall sleep quality and intra-shift fatigue of HEMS clinicians can be improved with real-time assessment and intervention.

Aim 1: To determine the short-term impact of an enhanced SleepTrackTXT intervention on HEMS clinician fatigue reported in real-time during and at the end of shift work.

Aim 2: To determine the long-term impact of the SleepTrackTXT intervention on sleep quality and sleep health indicators including hours of sleep and recovery between shift work.

The investigators will examine short term impact by examining self-reported fatigue captured at the start, during, and end of scheduled shifts.

The investigators will determine longer-term impact on sleep quality by comparing scores on the Pittsburgh Sleep Quality Index (PSQI) taken at baseline and then again at 4 months.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older
* working clinically at a study site
* currently working in shifts
* has a smart phone and
* willing to take part in a research study that requires the sending and receiving of multiple text messages daily over 4-months

Exclusion Criteria:

* does not meet inclusion criteria
Identifying Saliva Markers in Inflammatory Bowel Disease

Under normal conditions intestinal mucosa presents a baseline "physiological inflammation" caused by a controlled immune response that eliminates offending dietary and microbial antigens. This inflammation disappears once the cause is eradicated. In case of inappropriate immunological response, the inflammation becomes chronic and harmful, resulting in anatomical and functional abnormalities, namely inflammatory bowel disease (IBD).

Although it is critical for the IBD patients to undergo early diagnosis and management before the development of severe complications, but as IBD has vague and non-pathognomonic clinical features, the clinician is usually mislead into late suspicion and detection of IBD.

Diagnosis traditionally depended on a combination of pathologic evaluation together with the histological, clinical, radiological, endoscopic, surgical, laboratory (serological) features. Recently, serological markers were identified and became of special interest as they do not only detect the occurrence of IBD but also the potential of its development and may be used as prognostic tools. More recently, stool markers were detected and used for diagnosis.

Up to now, the market is still lacking a definitive, simple and non-invasive diagnostic tool. Saliva can present an alternative form of body fluids that simplify diagnostic procedures.

Our hypothesis is that IBD patients have special salivary biomarkers that may be identified through salivary analysis, where later on a simple non-invasive test can be applied in the form of an easy-to-use kit, being available at the clinician's clinic for the establishment of an immediate and early diagnosis of the destructive inflammatory bowel disease.


Eligibility Criteria:
Inclusion Criteria:

* Identified with inflammatory bowel disease

Exclusion Criteria:

* medically compromised children
* congenital syndromes
* children on medication chronically or on the day of the examination
* children treated with radiotherapy or chemotherapy.