cyrilzakka/clinical-trials huggingface dataset:
CART-19 T Cell in CD19 Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)

This is a single center, open-label phase 1/2 study to evaluate the safety and efficacy of targeted CD19 chimeric antigen receptor engineered T cell immunotherapy (CART) in the treatment of CD19 positive relapsed or refractory acute myeloid leukemia.

The patients will receive infusion of CART cells targeting CD19 to confirm the safety and efficacy of CD19 CART Cells in relapsed or refractory acute myeloid leukemia.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients with CD19+ relapsed/refractory acute myeloid leukemia
* Age 6-65 years.
* Left ventricular ejection fractions≥ 0.5 by echocardiography.
* Creatinine \< 1.6 mg/dL.
* Aspartate aminotransferase/aspartate aminotransferase \< 3x upper limit of normal.
* Bilirubin \<2.0 mg/dL.
* Karnofsky performance status ≥ 60
* Expected survival time ≥ 3 months (according to investigator's judgement)

Exclusion Criteria:

* Pregnant or lactating women.
* Uncontrolled active infection.
* Active hepatitis B or hepatitis C infection.
* Class III/IV cardiovascular disability according to the New York Heart Association Classification.
* HIV infection.
* Patients with history of seizure
* Active central nervous system leukemia
Chromatic Retinal Stimulation to Reduce Chronic Pain and Pain Sensitivity

Participants with chronic pain conditions including chronic low back pain and fibromyalgia may benefit from light stimuli presented to the retina to reduce chronic pain severity and pain sensitivity. Participants will be recruited into this study and will be presented with one of three uniform light stimuli via a wide-field ganzfeld in three conditions to determine the retinal mechanisms that reduce pain. This work will lead to a greater understanding of retinal mechanisms that contribute to pain and will assist the design of future studies to harness the potential of light based pain therapies.


Eligibility Criteria:
Inclusion Criteria:

* Adults greater than or equal to 18 and less than or equal to 65.
* Individuals who have been diagnosed with fibromyalgia or chronic low back pain by their physician.
* Individuals who experience an average pain severity greater than 4/10 in intensity at baseline.
* Willingness to wear a battery-operated portable ganzfeld light stimulator device for 2 hours per day at the same time each day (ideally complete the light therapy session between 5 am-10 am each morning) for 5 days.
* Alert and oriented, and able to provide informed consent
* Ability to read and speak English to complete validated questionnaires.

Exclusion Criteria:

* Vision disorders or conditions resulting in severe vision impairment or blindness
* Individuals with self-report of color blindness
* Prisoner Status
* Pregnancy
* No other history or condition that would, in the investigator's judgment, indicate that the patient would very likely be non-compliant with the study or unsuitable for the study (e.g., might interfere with the study, confound interpretation, or endanger the patient).
* History of seizure disorder
HYPID (Pulmonary Hypertension in Interstitial Lung Disease) EXTENSION

HYPID-2 study is an extension of HYPID study (NCT01443598) :

HYPID-2 is also an observational and prospective study of patients with interstitial lung disease and pre capillary hypertension diagnosed by right heart sided catheterization.

It concerns only incident patients (i.e patients included within 6 months after PH diagnosis) whereas HYPID concerned prevalent and incident cases.

The primary aim is the same than HYPID : identify prognostic factors

Pre capillary pulmonary hypertension (PH) may be present in patients with diffuse interstitial lung disease.

In this context, PH represents an important factor of morbidity and mortality for these patients.

As in HYPID, the main purpose of HYPID-2 is to determine predictive factors of mortality within this cohort of incident patients (i.e patients included within 6 months after PH diagnosis).

In order to reach that aim,the study includes an evaluation based on exams conducted for the routine follow-up of incident patients.

Each incident patient will be followed during 2 years at least.

Eligibility Criteria:
Inclusion Criteria:

Patients newly diagnosed with:

* Pre capillary pulmonary hypertension at right heart sided catheterization with: mPAP \> or = 25 mmHg, PCWP \< or = 15 mmHg
* Interstitial lung disease with diffuse infiltrative opacities on chest CT scan

Exclusion Criteria:

* Pulmonary hypertension related to a thromboembolic disease
* Respiratory disease other than diffuse interstitial lung disease
* Any etiological factor of pulmonary arterial hypertension based on NICE 2013 classification other than diffuse interstitial lung disease
* Any progressive disease associated to a life expectancy less than 6 months other than pulmonary hypertension, diffuse interstitial lung disease and respiratory insufficiency
Effect of Artemisinin-based Combination Therapies on Schistosomiasis on Malaria Co-infection

Open labelled, non randomized study to evaluate the effects of Artemisinin based Combined Therapies(ACTs) on schistosomiasis since Praziquantel (PZQ) which is presently the drug of choice for treating Schistosomiasis (STS), is ineffective on immature stages and there is known parasite resistance. ACTs when combined with PZQ, targeting different stages of the life cycle has shown some effectivity.

Study population included all subjects in study area who signed a written Informed Consent Form diagnosed with Malaria- STS co-infection. Those excluded were treated with PZQ prior 6 weeks, have drug intolerance or pregnant. At Inclusion, Basic Demographic data was recorded and urine samples analysed. During the follow up visits, urine samples were collected on D28 and D42 (6 weeks post treatment). Post treatment assessment was done on urine samples collected on at least two consecutive days and at the end of follow up, all subjects were treated with a single dose pf PZQ (40 mg/kg) as recommended by WHO.

Eligibility Criteria:
Inclusion Criteria:

* Malaria infection diagnosed by Rapid Diagnostic Tests (RDTs) or thick blood smear
* Urinary schistosomiasis diagnosed by presence of Schistosoma haematobium eggs in the urine before malaria treatment
* Written informed consent

Exclusion Criteria:

* Patients treated with PZQ during the previous 6 weeks
* Known intolerance /allergy to any study drug
* Pregnancy
Accuracy of 3DPrinted Windowed Bracket- Positioning Guide Compared To Thermoformed Indirect Bonding Tray

this study was aimed to evaluate of accuracy of 3DPrinted windowed Bracket- Positioning Guide in compare to Thermoformed Transfer Tray For Orthodontic Indirect Bonding


Eligibility Criteria:
Inclusion Criteria:

1. Age: above 13 years.
2. Complete set of permanent teeth including second molar.
3. No sex predilection.
4. Class I Mild to moderate crowding (4-6 mm).

Exclusion Criteria:

1. Surface enamel defect that compromise bonding
2. No or poor patient's compliance.
3. Psychological problems.
4. Pathology at the site of intervention.
5. Insufficient crown height that contradicts bonding of brackets.
6. Labial and buccal Restorations.
7. Poor oral hygiene.
8. Severely rotated teeth
Cognitive Stimulation Therapy for Dementia

Aim:

The aim of this study is to reveal the effectiveness of cognitive stimulation therapy on activities of daily living, depression and life satisfaction in individuals with mild dementia living in nursing homes.

This randomized controlled experimental study was conducted between 30 March-27 May 2022, with a total of 60 individuals (30 in control and 30 in intervention group) living in Adana and Seyhan Nursing Home Elderly Care and Rehabilitation Centers. The data of the study were collected with the Personal Information Form based on the literature, the Standardized Mini Mental Test (SMMT), the Barthel Activities of Daily Living Index, the Lawton and Brody Instrumental Activities of Daily Living (IADL) Scale, the Cornell Dementia in Dementia Scale (CDS) and the Satisfaction with Life Scale. In order to conduct the study, the approval of the Clinical Research Ethics Committee, written institutional permission and written permission from the participants were obtained. The individuals in the intervention group started with the introduction and pre-test application in the first week and applied CST for 45 minutes twice a week for the next 7 weeks, while the individuals in the control group started with the introduction and pre-test application in the first week and performed two sessions for one week and two days and continued their daily lives in the following weeks. The study was terminated in 9 weeks by applying the post-test to both groups in the last week. Due to the 3-month follow-up study, measurements will be made for the last time in September with the SMMT, BADL, IADL, CDS and LDL measurement tools.After being informed about the study, all individuals with dementia were given written informed consent form.

Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with dementia according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM V) by a physician
* Agree to participate in the study
* Being literate and speaking Turkish fluently
* Have communication and understanding skills
* Standardized Mini Mental Test result being between 18-23 points
* Having adequate vision and hearing functions for group participation

Exclusion Criteria:

* Presence of any sensory impairment
* Having a physical health problem that may impair group cohesion and integrity
Combined Microbiota and Metabolic Signature in Ulcerative Colitis Predicts Anti-Inflammatory Therapy Success

The primary goal of the study is to develop an early (within 4 weeks) combined microbiota/metabolic signature predicting clinical response upon anti-inflammatory treatment in UC patients.

The investigators perform a longitudinal prospective multi-center study for ulcerative colitis (UC) patients with a flare at/and after the time of starting a new treatment and healthy household controls. They will perform intense longitudinal bio-sampling and deep clinical characterization.

With this information the aim is to develop a predictive signature regarding the success of a new ly started anti-inflammatory therapy after an UC flare.

Eligibility Criteria:
Inclusion criteria ulcerative colitis:

1. Signed informed consent
2. Age 18-80 years
3. General ability to understand and follow study procedures, fluency in German, French, or English
4. Diagnosis of ulcerative colitis since ≥3 months
5. Confirmed flare of ulcerative colitis with partial SCCAI score ≥5 points and at least one biomarker supporting intestinal inflammation
6. Planned start with ozanimod, steroids (prednisone ≥20mg/d or equivalent), or a biological (vedolizumab, infliximab, adalimumab, golimumab, ustekinumab)

Exclusion criteria ulcerative colitis

1. Confirmed cytomegalovirus (CMV) reactivation within the previous 2 weeks (tested as part of standard medical practice at the discretion of the responsible physician)
2. C. difficile related diarrhea, or other confirmed infectious diarrhea in the last 4 weeks (tested as part of standard medical practice at the discretion of the responsible physician)
3. Diagnosis of Crohn's disease
4. Current pouch or ileostomy/ colostomy
5. Severe medical, surgical, or psychiatric comorbidities interfering with study procedures

Inclusion criteria controls

1. Signed informed consent
2. Age 18-80 years
3. General ability to understand and follow study procedures, fluency in German, French, or English
4. No current or past diagnosis of inflammatory bowel disease (IBD)
5. No current medical complaints typic for IBD e.g.

   * Diarrhea, severe constipation, abdominal pain, blood in stool, weight loss
   * Slight symptoms (without impact onto daily activities) are permitted
6. No other current relevant gastrointestinal disease or condition plausibly interfering with microbiota assessment according to the discretion of the study physician

Exclusion criteria controls

1. Confirmed cytomegalovirus (CMV) reactivation within the previous 2 weeks
2. C. difficile related diarrhea, or other confirmed infectious diarrhea in the last 4 weeks
3. Diagnosis of Crohn's disease, ulcerative colitis
4. Current pouch or ileostomy/ colostomy
5. Severe medical, surgical, or psychiatric comorbidities interfering with study procedures
MEDI5752 in Combination With Carboplatin Plus Pemetrexed in Unresectable Pleural Mesothelioma

This is a phase III, randomized, open-label, multicenter, global study to determine the efficacy and safety of Volrustomig (MEDI5752) + Carboplatin + Pemetrexed vs the investigator's choice of platinum + Pemetrexed or Nivolumab + Ipilimumab in participants with unresectable pleural mesothelioma.

Adult patients with histologically proven diagnosis of pleural mesothelioma with advanced unresectable disease are eligible to be enrolled. Patients will be randomized 1:1 to receive Volrustomig (MEDI5752) + Carboplatin + Pemetrexed or the investigator's choice of platinum+Pemetrexed or Nivolumab+Ipilimumab, based on their histology.

Eligibility Criteria:
Key Inclusion Criteria:

* Participant must be ≥ 18 years at the time of screening
* Histologically proven diagnosis of pleural mesothelioma with known histology (epithelioid vs. non-epithelioid)
* Advanced unresectable disease that cannot be treated with curative surgery (with or without chemotherapy)
* WHO/ECOG performance status of 0 or 1 with no deterioration (that is, ECOG PS\>1) over the previous 2 weeks prior to day of first dosing
* Has measurable disease per modified RECIST1.1
* Has adequate bone marrow reserve and organ function at baseline

Key Exclusion Criteria:

* As judged by the investigator, any condition that would interfere with evaluation of the investigational product or interpretation of participant safety or study results.
* Active or prior documented autoimmune or inflammatory disorders
* History of another primary malignancy with exceptions.
* Uncontrolled intercurrent illness
* Tuberculosis, hepatitis B (HBV) or hepatitis C (HCV), human immunodeficiency virus (HIV) infection that is not well controlled
* Any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment
* Untreated or progressive CNS metastatic disease
Immunogenicity and Interchangeability of Two Inactivated Hepatitis A Vaccines

This is a randomized, double-blind clinical trial of two inactivated hepatitis A vaccines in healthy children, immunogenicity and interchangeability of the two inactivated hepatitis A vaccines were evaluated.

This was a monocenter, comparative trial in which healthy children were randomized to receive two doses of hepatitis A vaccine 6 months apart. The trial was conducted in accordance with the Edinburgh version of the Declaration of Helsinki. The study was approved by the Ethics Committee. Parents or legal guardians of all participants gave written informed consent prior to study entry. Eligible subjects were between 18m and 6 years of age, When enrolled, children were randomized to four equal groups with different intervention. Immunogenicity and interchangeability of two inactivated hepatitis A vaccines were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children aged between 1.5 and 5 years, with no history of hepatitis A virus infection or hepatitis A vaccine vaccination
* Provided birth certification or vaccination card
* Parent(s) or legal guardian(s) are able to understand and sign the informed consent

Exclusion Criteria:

* Axillary temperature \> 37.0 centigrade at the time of dosing
* Subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine
* Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
* Autoimmune disease or immunodeficiency
* Congenital malformation, developmental disorders or serious chronic diseases (such as Down's syndrome, diabetes, sickle cell anemia or neurological disorders)
* Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
* History or family history of convulsions, epilepsy, brain disease and psychiatric
* History of any blood products within 3 months
* Administration of any other investigational research agents within 30 days
* Administration of any live attenuated vaccine within 30 days
* Administration of subunit or inactivated vaccines within 14 days
* Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
Effectiveness of Music Practical Examinations

College student anxiety is rising alarmingly and directly affects academics, occupations, and well-being. Occupational therapy (OT) students encounter a rigorous workload and pressure to become entry-level practitioners. Higher education faculty strive for evidence-based teaching strategies and effective classroom management and are often challenged to promote a positive classroom culture. This quasi-experimental study explored the effect of listening to music during a lab practical examination on the performance of OT graduate students.

Through convenience sampling, 68 graduate students in an occupational therapy program were recruited to participate. The quasi-experimental study was conducted at Russell Sage College, in Troy, New York, with approval from the International Review Board Inclusion criteria were male and female first and second-year students, ages 19-34, enrolled in Functional Anatomy and Kinesiology or Physical Agent Modalities. The data was collected during lab practicals in December 2021 and June 2023. Forty-three students signed consent forms to participate. Students sign up for 20-minute time slots in pairs for the practical exam. Each student randomly selects confidential assessment cards and takes turns independently completing their assignment. Each practical contains a grading rubric, and a score of 80 is required to pass. Students either had one private room when an examiner during the practical, and either it was quiet or low 60 bpm music played in the background. Pre and post-outcome measures evaluated each student's state, trait, test anxiety, blood pressure, and heart rate outside the assessment room. State and trait anxiety was measured using the State-Trait Anxiety Inventory for Adults™ by Charles D. Spielberger and the Test Anxiety Inventory by Charles D. Spielberger \& Associates. State-Trait Anxiety is cited in over 20,000 articles and is the primary assessment used most often for individuals susceptible to anxiety. The reliability of the State-Trait Anxiety is .86 - .95, and substantial evidence confirms its validity. Mean S-anxiety .59, T- T-anxiety .57 college students of both sexes. The Test Anxiety Inventory measures individual situational anxiety of symptom frequency throughout an exam, like apprehension and nervousness. Remote online survey licenses were purchased to administer the State-Trait Anxiety Adult and Test Anxiety Inventory on each student's laptop. Mind Garden's Transform System collected raw scaled scores. The research team recorded blood pressure and heart rate with the digital Blood Pressure monitor with an upper arm cuff.

Eligibility Criteria:
Inclusion Criteria:

* Graduate occupational therapy students enrolled in Functional Anatomy and Kinesiology or Physical Agent Modalities

Exclusion Criteria:

* Students not registered for Functional Anatomy and Kinesiology or Physical Agent Modalities
Comparison Between Custom and Non-custom Serious Games Poststroke

Serious games for rehabilitation are delivered through systems that are either customised or non-customised. Custom serious games allow for control of feedback, setting of game speed and difficulty, while non-custom games are less adaptable but provide attractive graphics and sounds. The study compared the activity intensity and user experience of persons after stroke while playing custom and non-custom virtual reality balance games that were both game- and self-paced.

Persons in chronic phase poststroke will play 12 games (6 self- and 6 game-paced games) over two sessions (in randomised order). Within each game-type, custom and non-custom games will be played in random order. All games will be played on a balance board, whereby each pair of a custom and non-custom game will require comparable movement directions of the center of pressure. The custom system will be compared to the non-custom system in terms of number of repetitions, movement amplitude, users' enjoyment, flow state, likeability and perception of exertion.

Eligibility Criteria:
Inclusion Criteria:

* chronic phase (\>6 months) after stroke
* ability to walk with supervision or independently with or without walking aid on flat ground or all surfaces
* stable health condition
* ability to follow simple instructions

Exclusion Criteria:

* additional neurological condition
* musculoskeletal impairments that would interfere with execution of the required tasks or completing the questionnaires
Pre-emptive Topical Lidocaine 5% Plaster for Prevention of Post-craniotomy Pain

Postcraniotomy pain remains a common phenomenon in the neurosurgery field. Managements for postcraniotomy pain are to be standardised and optimized. In the proposed study, the investigators aim to provide a novel regional non-invasive prophylactic strategy for postcraniotomy pain by utilizing Lidocaine 5% plaster.

Postcraniotomy pain remains a common phenomenon in the neurosurgery field. Insufficient control of postcraniotomy pain may lead to unexpected clinical outcomes. The current management for postcraniotomy pain mainly involves systemic intravenous or oral medication and regional anaesthetic injection.

The investigators intend to compare pre-emptive lidocaine 5% plaster incision covering to a placebo for prophylaxis of postcraniotomy pain. In the proposed study, the effectiveness and safety of lidocaine 5% plaster for postcraniotomy pain control will be examined compared with those of placebo. The investigators aim to provide a novel regional non-invasive prophylactic strategy for postcraniotomy pain.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 or older
* American Society of Anesthesiologists status I or II
* Registered for elective craniotomy
* Informed consent for participation in the trial

Exclusion Criteria:

* Allergy to lidocaine or the hydrogel plaster
* Chronic headache, craniofacial pain or neuralgia
* Glasgow Coma Scale less than 15
* Current or previous cardiovascular or cerebrovascular accident
* Expected delayed recovery or extubation
* Uncontrolled arrhythmia
* History of intracranial operation
* Emergency or revision craniotomy
* Mental illness, psychiatric drug use or alcohol abuse
* Failure to understand the use of a 100 mm VAS or the PCA
Additional Metabolic and Vascular Effects of Exercise in Patients on Diet-based Weight Loss Programs

This study tests the hypothesis that exercise training can confer additional benefit to patients in weight-loss programs in the form of improvements in either metabolic or vascular parameters or both. Patients will be randomized to either diet plus conventional physical activity or diet plus a planned exercise training. The interventions will be carried out until the patients lose between 5% and 7.5% of their initial weight. At entry and at the end, all subjects will be evaluated for outcomes such as blood glucose, lipid profile, insulin, c-reactive protein, fibrinogen, vascular reactivity (doppler ultrasound) and total and abdominal visceral fat (CT-scan). Both groups will be compared.


Eligibility Criteria:
Inclusion Criteria:

* BMI\> 30 and \<40

Exclusion Criteria:

* Diabetes mellitus
* Active endocrine disease
* Active heart disease
* Active smoking
* Medical contra-indications for exercise
* Using anti-obesity drugs