cyrilzakka/clinical-trials huggingface dataset:
Immunotherapy With CD22 CAR T-cells for B-Cell Lymphoma, ALL and CLL

This study aims to evaluate the safety, efficacy and duration of response of CD22 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD22+ haematological malignancies.

This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD22 Chimeric Antigen Receptor (CAR) T-cells (CD22 CAR T-cells) in patients with high risk, relapsed CD22+ haematological malignancies (Leukemia and lymphoma). Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD22 CAR Tcells. Patients will receive the CD22CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD22 CAR T-cells in patients with high risk relapsed CD22+ malignancies

Eligibility Criteria:
Inclusion Criteria:

1. Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphoblastic leukemia(CLL) and non-hodgkin lymphoma.
2. KPS\>60.
3. Life expectancy\>3 months.
4. Gender unlimited, age from 2 years to 70 years.
5. CD22 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry.
6. Patients who have failed at least one line of a standard treatment.
7. No serious mental disorder.
8. Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(Cr≤133umol/L).
9. No other serious diseases(autoimmune disease, immunodeficiency etc.).
10. No other tumors.
11. Patients volunteer to participate in the research.
12. Patients with history of allogeneic stem cell transplantation are eligible if at least 100 days post-transplant, if there is no evidence of active GVHD and no longer taking immunosuppressive agents for at least 30 days prior to

Exclusion Criteria:

1. KPS\<50.
2. Patients are allergic to cytokines.
3. Central nervous system leukemia within 28 days.
4. Uncontrolled active infection.
5. Acute or chronic GVHD.
6. Treated with T cell inhibitor.
7. Pregnancy and nursing females.
8. HIV/HBV/HCV Infection.
9. Other situations we think improper for the research.
A Study of the Safety of Individualized Combination Therapy With Copegus (Ribavirin) and Pegasys (Peginterferon Alfa-2a) in Patients With Chronic Hepatitis C (MASTER)

This open-label, non-comparative study will assess the safety and tolerability of individualized combination therapy with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients with hepatitis C virus (HCV) genotype 1 (Group A) will receive Copegus 1'000 mg or 1'200 mg daily orally for 24-72 weeks. For patients with genotype 2 or 3 HCV (Group B) the Copegus dose will be 800 mg daily for 16-48 weeks. Patients who had previously received standard or pegylated interferons but were non-responders or with relapse (Group C) will receive Copegus 1'000 mg or 1'200 mg daily for up to 72 weeks. Concomitant therapy with Pegasys 180 mcg subcutaneously weekly will be given to all patients. Anticipated time on study treatment is up to 72 weeks with a 24-week follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Chronic hepatitis C
* Measurable serum HVC RNA levels
* Compensated liver disease (Child-Pugh class A)
* Treatment-naive for standard or pegylated interferons, or non-responder or relapsing

Exclusion Criteria:

* Concomitant hepatitis A or B
* History of chronic liver disease not caused by hepatitis C virus
* Hepatocellular carcinoma
* History or signs of esophageal varices haemorrhage or other conditions indicative of decompensated liver disease
* Treatment with any systemic anti-tumor or immunomodulatory agent (including steroids at doses exceeding physiological ones, and radiotherapy) within 6 months prior to first dose of study drug
* Pregnant or lactating women, or men whose partners are pregnant
A Study of How the Body Breaks Down and Eliminates LY2623091

This type of study is called a radiolabeled study. For this study, LY2623091 (study drug) has been specially prepared to contain radiolabeled carbon \[\^14C\]. \[\^14C\] is a naturally occurring radioactive form of the element, carbon. This study will increase understanding about how the drug appears in the blood, urine, and stool after it is administered to healthy participants. Information about any side effects that may occur will also be collected. This study will last up to 22 days for each participant, not including screening. Screening is required within 28 days prior to enrollment


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy males; as determined by physical examination, clinical laboratory tests, medical history and electrocardiograms (ECGs).
* With a body mass index of 18.5 to 32.0 kilogram per square meter (kg/m\^2), inclusive.

Exclusion Criteria:
Peer Support in Alcohol Dependence

Alcohol use disorder (AUD) affects between 4% and 6% of French adults, and requires appropriate medical treatment.

However, 20-40% of patients with AUD are lost to follow-up at an early stage. Consequently, it is important for addiction departments to implement and evaluate innovative tools and interventions, including the involvement of peer support, to help patients remain in care, and to assess whether peer support has a positive impact on their clinical outcome.

Addiction peer support specialists (APSSs) are individuals who have personally experienced addiction, and who have decided to use their experience to assist other people going through a similar situation, after completing a specific official graduation.

Compared to other caregivers, APSSs may induce in patients a sense of identification which could improve the patient motivation to engage and remain in care.

This is the main hypothesis and the main scientific objective of the PEERSIAD study, which will aim to confirm that accompanying patients with AUD using APSSs after alcohol detoxification, reduces the rate of lost-to-follow-up and improves the overall clinical outcome.


Eligibility Criteria:
Inclusion Criteria:

* Aged ≥ 18
* Socially insured
* Meeting DSM-5 criteria for alcohol use disorder (AUD)
* Abstinent from alcohol and involved in supervised alcohol withdrawal for at least 5 days and no more than 21 days (outpatient or inpatient)
* Starting a post-detoxification outpatient program

Exclusion Criteria:

* Other severe substance use disorder, i.e. DSM-5 criteria ≥ 6 (excluding tobacco)
* Patient under protective measure (safeguard measure, guardianship) or deprived of liberty or in ordered care and hospitalization measures without consent.
* Inability to communicate and express oneself orally in French, compromising the possibility of exchanges between the Peer support and the patient.
* Psychiatric or cognitive comorbidities making inclusion impossible, at the investigator's discretion.
* Individual accompaniment by a Peer support in the 15 days prior to inclusion.
Comparison of Patients' Postpartum Recovery Using ObsQoR-10 Score in Pregnant Women in Vaginal Delivery With and Without Neuraxial Labor Analgesia

The aim of this study was to compare the postpartum recovery of pregnant women who had vaginal delivery with and without neuraxial labor analgesia using the ObsQoR-10 scoring system.

In this study, we planned to conduct a study to compare the postpartum recovery of pregnant women according to patient-reported outcome measures using the ObsQoR-10 score in vaginal deliveries with and without neuraxial labor analgesia (dural puncture epidural or combined spino epidural analgesia).

In this study, after obtaining the approval of the ethics committee of Atatürk University Faculty of Medicine Hospital and written informed consent of the patients, 40 pregnant women who will deliver vaginally with or without neuraxial analgesia will be prospectively enrolled.

Patients will be randomized by a statistician using a computerized random numbers table and divided into 2 equal groups as Group A and Group B. Pregnant women in Group A will receive neuraxial labor analgesia (dural puncture epidural or combined spino epidural analgesia), while Group B will not. If postpartum analgesic needs arise, patients in Group A will receive 0.0625% bupivacaine via epidural route, while pregnant women in Group B will receive iboprufen and acetaminophen if needed.

ObsQoR-10 scores of the postpartum patients will be evaluated and recorded at discharge. In addition, basic demographic information and medical, analgesic and obstetric parameters related to the peripartum period will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Being ≥18 years old
* Pregnant women consenting to neuraxial analgesia for labor
* Being ≥37 weeks gestation

Exclusion Criteria:

* Patients in whom neuraxial analgesia is contraindicated
* Being \<18 years old
* Being \<37 weeks gestation
Analgesia-Based Sedation During Mechanical Ventilation

Hypothesis: A protocolized algorithm for sedation in critically ill patients on mechanical ventilation can decrease ventilator days, costs and improve outcome.

This is a multicenter observational-interventional study on critically ill patients who require mechanical ventilation for more than 48 hours, involving 13 ICU in Chile. There are two periods (groups): a descriptive phase of sedation practices, and an interventional period in which an analgesia-based, goal-directed, nurse-driven sedation is applied.

Main outcome: ventilator-free days between both periods.

This is a multicenter observational-interventional study on critically ill patients who require mechanical ventilation for more than 48 hours, involving 13 ICU in Chile.

Main exclusion criteria are neurologic impairment, previous chronic cardiac, liver and renal failure, second period of mechanical ventilation during hospitalization, short term expected mortality.

There is an initial descriptive phase of sedation practice, involving sedative drugs, sedation level assessment, and outcome: ventilator-free days, ICU stay, costs and mortality.

After a period of analysis and training, an analgesia-based, goal-directed, nurse-driven sedation protocol is applied. Fentanyl infusion is started and titrated to obtain a patient calm and cooperative or mildly sedated while on mechanical ventilation. Hypnotics and opiates i.v. boluses are allowed during the first hours of mechanical ventilation. Midazolam infusion is started if ventilatory distress continue despite fentanyl 1.8 µg/kg/min. Haldol, muscle relaxants and other sedative drugs are allowed depending on patient condition. After 48 hours of mechanical ventilation, sedative drugs are discontinued in the morning.

Main outcome: ventilator-free days. Secondary outcome: ICU stay, costs, and sedation quality. At 6 moths SF-36. Each period is planned to included at least 140 patients, for a 20% difference in ventilator-free days, with 80% power and a 0.05 type I error.

Eligibility Criteria:
Inclusion Criteria:

* Patients who require mechanical ventilation for more than 48 hours

Exclusion Criteria:

* Nervous system diseases
* Previous liver or renal failure
* Second episode of MV during same hospitalization
* Expected MV shorter than 48 hours
* Short term expected mortality.
A Study of BIIB022 in Combination With Paclitaxel and Carboplatin in Subjects With Non-Small Cell Lung Cancer

The purpose of this study is to determine whether BIIB022, Paclitaxel and Carboplatin are effective in the treatment of Treatment-Naive, Stage IIIB/IV Non-Small Cell Lung Cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age \>/= 18 years old
* Treatment-naive Stage IIIB/IV Non-Small Cell Lung Cancer
* ECOG Performance Status 0 or 1

Exclusion Criteria:

* History of another primary cancer within 3 years
* Any prior or concurrent investigational or standard therapy for treatment of NSCLC
* Prior anti-IGF-1R therapy
* Unstable diabetes
Sensory Training to Treat Focal Dystonia

This study will examine the effectiveness of Braille reading as a sensory training program for improving symptoms of focal (localized) dystonia, a movement disorder caused by sustained muscle contractions. Musicians, writers, typists, athletes and others whose work involves frequent repetitive movements may develop focal dystonia of the hand. Dystonia patients have an impaired sense of touch, and it is thought that symptoms may improve with sensory tactile (touch) training.

Patients with task-specific dystonia and healthy normal volunteers may be eligible for this 8-week study. Patients will undergo evaluation of their dystonia and a complete neurologic examination. Healthy volunteers will have a complete physical examination.

On the first day of the study, after 4 weeks and after 8 weeks, all participants will have a gap detection test for sensory perception testing. The test uses eight plastic devices called JVP-Domes with ridges of different widths on the surface. The subject's arm and hand are held in palm-up position and the right index finger is tested for about 1 second 20 times with each dome. The subject is asked to report whether the direction of the dome is vertical or horizontal. The test takes about 30 minutes. Patients with dystonia will also have a their symptoms evaluated at these visits. The evaluation involves completing a written questionnaire and writing a paragraph.

All participants will be trained in Braille reading at NIH. Sessions will be given every day the first week, twice a week the second and third weeks, and once a week the following weeks.

It has been hypothesized that dystonia may be a sensory disorder. Animal studies as well as physiological studies of patients with focal dystonia have demonstrated sensory dysfunction. It has also been shown that patients with dystonia have impaired sensory perception including when assessed with the JVP gap detection test. This could possibly result from enlargement and dedifferentiation of representations in the sensory cortex. We therefore hypothesize that sensory training could improve the impaired sensory perception and hence improve the dystonia. This study will examine if Braille reading as a sensory training program can correct the sensory perception and the dystonia. The primary outcome is improvement in the JVP gap detection test.

Eligibility Criteria:
Patients with idiopathic task specific dystonia and healthy normal volunteers.

Patients must not be receiving botulinum-toxin treatment or other medications for the past three months prior to entering the study.

Patients must be able to keep their hand in a pronated 'reading' position for one hour.
A Potential Role for Oxygen in the Development of Mental Fatigue and the Subsequent Decline in Cognitive Performance

Introduction Both Mental Fatigue (MF) and hypoxia impair multiple aspects of cognitive functioning. The decline in cognitive functioning in hypoxic conditions is associated with alterations in brain oxygenation and hemodynamic responses. These hemodynamic responses are preferably measured at the prefrontal cortex, an area of the brain that is known for its executive function and role in decision making, planning, attention and (short-term) memory. This study will investigate the role of prefrontal cortex oxygenation during the development of mental fatigue and during cognitive performances by altering the ambient oxygen availability through normobaric hypoxia (3800m; 12,9% O2) and normoxia.

Methods Subjects will perform four trials in a sound-insulated climate chamber (20°C and 40% RH). Upon entry in the climatic chamber participants will adapt to the environment for 30 minutes. Next, they will perform a modified cognitive test battery "cognition", a fine motor task "Motor Performance Series" and a visuomotor-fitlight task before and after a 60-minute individualized Stroop task or control task (randomized. blinded, placebo controlled, counter-balanced, cross-over design). Nearinfrared spectroscopy (NIRS) will be used to assess hemodynamic changes (oxygenated hemoglobin (O2Hb), deoxygenated-hemoglobin (HHb) and total hemoglobin (tHb)) at the PFC.

Hypotheses 1) MF will lead to earlier changes in the prefrontal NIRS-parameters (O2Hb, HHb, tHb) with lower oxygen availability. 2) The effects of MF on cognitive performance manifest itself to a greater extent with lower oxygen availability.3) Visuomotor performance declines to a greater extent due to MF with lower oxygen availability.


Eligibility Criteria:
Inclusion Criteria:

* Healthy (No neurological or cardiovascular disorders)
* Male or female
* No medication
* Non-smoker
* Between 18 and 35 years old
* Recreational athlete population; performance level 2 or 3 for men according to De Pauw et al. (2013)\[29\] and performance level 2 or 3 for woman according to Decroix et al. (2015)
* Non-acclimatized to altitude (at least 2 months)

Exclusion Criteria:

* Injuries
* Acclimated to altitude
* Use of medication
* Use of caffeine and heavy efforts 24 hours prior each trial
* Not eating a standardized meal, the morning of each trial
Malignant Wounds, Wound Treatment, Psycho-Social Support and Relaxation Therapy

The purpose of this study is to investigate whether treatment for cancer patients with malignant wounds can improve (wound healing/wound size, odor, infection, seepage, pain) through comparing the effects of two multidimensional interventions including wound treatment, psycho-social support and relaxation therapy.

Objective: To investigate whether treatment for cancer patients with malignant wounds can improve (wound healing/wound size, odor, infection, seepage, pain) through comparing the effects of two multidimensional interventions:

1. wound treatment (silver product, alginate and foam dressing \>\< honey product, alginate and foam dressing) in combination with,
2. psycho-social support (based on the structure in cognitive therapy) and
3. relaxation therapy.

Furthermore to investigate coping strategies, body image, stigma and quality of life in cancer patients with malignant wounds.

Design: A hypothesis testing prospective randomized clinical intervention study (n=70) and an explorative qualitative interview study

Method: Digital photographing, measurement of wound size with Quantify-Image-One, wound morphology registration (the extent of malodour, infection, seepage, bleeding, pain, the healing process), grafting, VAS-score, quality of life questionnaire (EORTC-QLQ-C30, DLQI), Hospital Anxiety and Depression Scale (HAD), Mental Adjustment to Cancer (MAC), interview.

Patients will fill out a diary focusing on wound related problems.

Perspectives: The results will determine whether the honey treatment is an improvement, and whether the silver treatment has statistical and clinical significance.

The qualitative study will contribute new knowledge about conditions of life for cancer patients with cancer wounds, their feelings and impositions.

In spite of proving positive effect, the project will contribute with new required knowledge on treatment and support for cancer patients suffering from malignant wounds.

Eligibility Criteria:
Inclusion Criteria:

* Cancer with evidence of disease.
* Cancer wound \>2 cm.
* Receiving antineoplasm treatment.
* \> 18 years.
* Receiving antineoplasm treatment in out-patient clinic.
* Read, speak and write Danish.

Exclusion Criteria:

* No radiation therapy the last 6 month (on the wound).
* Life expectancy \> 3 month.
* Not psychotic.
An Optional Investigation of Biomarkers of Efficacy

House Dust Mites (HDM) are arachnids that infest bedding, carpet, upholstered furniture and fabric. Like many other allergens, exposure to HDMA in sensitised patients is associated with poorer lung function, greater medication requirements and more asthma symptoms as well as chronic rhinosinusitis symptoms. In contrast to other allergens, there is evidence that HDMA leads to the development of asthma, in addition to exacerbating pre-existing asthma in HDM-sensitised patients.

ToleroMune House Dust Mite (TM-HDM) is being developed for the treatment of HDM allergy.

Study TH002 evaluated the efficacy, safety and tolerability of TM-HDM. This study will identify cellular, proteomic or genetic biomarkers of efficacy to TM-HDM treatment in TH002 study participants


Eligibility Criteria:
Inclusion Criteria:

* Previously randomised into study TH002, completed the study and received either placebo or the 12 nmol dose in TH002.

Exclusion Criteria:

* Subjects who have received allergen or peptide immunotherapy during the last 12 months (other than TM-HDM)
Virtual Reality Relaxation to Decrease Dental Anxiety

The aim is to apply short-term virtual reality relaxation to examine if it is effective in reducing pre-operative dental anxiety in primary health care using an RCT.

Randomized controlled single-center trial with two parallel arms: Virtual Reality Relaxation (VRR) and Treatment As Usual (TAU) in a public oral health care unit. VRR group receiving a 1-3.5 minute 360° video immersing them in peaceful virtual landscape with audio features and sound supporting the relaxing experience. TAU groups remaining seated for 3 minutes in similar setting.

Eligibility Criteria:
Inclusion Criteria:

* attending for dental treatment
* consenting
* able to complete Finnish questionnaire without assistance
* age 18 years or older

Exclusion Criteria:

* those not meeting inclusion criteria
Will Cap-Assisted Colonoscopy Improve Performance of Colonoscopy: A Randomized Clinical Trial

Observing the effects of an Olympus cap on the visibility and in adenoma detection during colonoscopy.

To see if Colonoscopy with the CAP is able to give more visibility and to see if detection rate for adenomas, polyps are easier to detect.

Eligibility Criteria:
Inclusion Criteria:

* Patients already booked for a colonoscopy

Exclusion Criteria:

* History of Colorectal Cancer
* Severe colitis
* Cancer
* poor bowel prep
The Effect of Recruiting Inactive Blood Donors Using Different Means

14098 inactive donors were randomly divided into three groups according to age, sex, blood donation frequency,time of last donation and blood donation site, one group acted as the control group, one will be recruited by telephone recruitment on "need", and one will just be called for improvement suggestions of blood donor service.


Eligibility Criteria:
Inclusion Criteria:

* inactive donors during 2016-2018

Exclusion Criteria:

* inactive donors during 2016-2018 but not eligible to donate