cyrilzakka/clinical-trials huggingface dataset:
Clinical Trial to Evaluate the Safety and Efficacy of IM19 CAR-T Cells in Patients With Relapsed and Refractory (R/R) B-cell Acute Lymphoblastic Leukemia

This is a open-label to assess the efficacy and safety of IM19 CAR-T cells in R/R B-cell Acute Lymphoblastic Leukemia.


Eligibility Criteria:
Inclusion Criteria:

* Relapsed or refractory B-ALL, defined as：1）Not chieving a CR after 1 cycle of standard chemotherapy for relapsed leukemia. 2）Any relapse after HSCT and must be ≥ 6 months from HSCT at the time of IM19 CAR-T cells infusion. 3）Primary refractory as defined by not achieving a CR after 2 cycles of a standard chemotherapy regimen.
* Patients with Ph+ ALL are eligible if they are intolerant to or have failed two lines of TKI ± chemotherapy ；Ph + all patients with T315I mutation are not required to receive at least two TKI ± chemotherapy in the absence of effective TKI therapy.
* Morphological evidence of disease in bone marrow (at least 5% blasts).
* Aged 3 to 70 years.
* Estimated life expectancy \>3 months.
* ECOG performance status of 0 or 1(age ≥ 16 years) or Lansky (age \< 16 years).
* Women of childbearing age who had a negative blood pregnancy test before the start of the trial and agreed to take effective contraceptive measures during the trial period until the last follow-up; male subjects with fertility partners agreed to take effective contraceptive measures during the trial period until the last follow-up.
* Adequate organ function.
* Volunteer to participate in this trial and sign on the informed consent.

Exclusion Criteria:

* Subjects with lsolated extramedullary disease relapse.
* Subjects with Burkitt's lymphoma.
* Subjects has obvious symptoms of central nervous system invasion and needs targeted treatment.
* Subjects has previously received gene product therapy.
* Subjects has graft-versus-host response（GVHD） and need to use immunosuppressants or GVHD ≥ grade 2 or being treated with anti GVHD or suffering from autoimmune diseases.
* Subjects has received chemotherapy or radiotherapy within 3 days before leukapheresis.
* Subjects received systemic steroids within 5 days prior to leukapheresis.
* Subjects received drugs that stimulated the production of hematopoietic cells in the bone marrow for 5 days prior to leucapheresis.
* Subjects has participated in other clinical studies within 1 month before screening or plan to participate in other drug clinical trials during this study.
* Subjects received allogeneic cell therapy within 6 weeks before leukapheresis.
* Subjects with History or presence of CNS disorder.
* Subjects with HBV, HCV, HIV ,EBV,ECV or syphilis infection at the time of screening.
* Pregnant or lactating, or planning pregnancy within 180 days after the end of CAR-T cells infusion, or male patients whose partners plan pregnancy 180 days after their CAR-T cell infusion.
* Subjects with other tumors in the past 5 years.
* Within 14 days before enrollment, there were active or uncontrollable infections requiring systemic treatment.
The ICU DElirium in Clinical PracTice Implementation Evaluation Study Screening and Treatment

Objective: Delirium is an important and frequently occurring complication in intensive care patients. However, screening and treatment of delirium is not in accordance with current national and international guidelines. The first objective of this prospective study is to describe the barriers and facilitators for guideline adherence. Second, investigators will develop a tailored implementation strategy. Finally, investigators will describe the effects of the tailored implementation on the adherence of the guideline in a pilot study. Design: Current practices, attitudes and deviations from a national (Dutch) delirium guideline will be assessed in a prospective before-measurement. Barriers and facilitators will be identified with surveys and focus group interviews. Adherence to the guideline will be studied in a before-after study in 7 ICUs in the Southwest of the Netherlands. Further, the effect of a multifaceted implementation strategy-guided implementation will be assessed with regard to important clinical outcomes, such as mortality and delirium incidence. Population: Professionals (Physicians/intensivists, nurses' and psychiatrists) and ICU patients. Intervention: The delirium guideline of the Netherlands Society of Intensive Care (NVIC) is implemented in this study. Implementation strategies: Barriers and facilitators will be determined in focus group interviews (n=7) with health care professionals resulting in a tailored guideline implementation strategy. In the development of the strategies specific attention will be paid to sustaining the guideline adherence. Main outcome: 1. Current practices; 2. Barriers and facilitators for guideline adherence; 3. Tailored implementation strategy; 4. Percentage of adherence to the guideline (early screening, prevention and treatment of delirium); 5. Effects of implementation on outcomes (economic, mortality, delirium incidence). Data analysis / power: The main effects, guideline adherence, will be evaluated by comparing the before and after measurements. Calculating from 90% power,2-sided alpha=0.01, 231 patients per periods will be sufficient to test the proposed adherence of 85%. Economic evaluation: The economic analysis will be performed from a health care perspective. Investigator will calculate and compare the direct medical costs of usual care (before) and care after implementation of the guideline. Additionally, the cost of the tailored guideline implementation process will be calculated. The economic analysis will be a cost-minimalization analysis.


Eligibility Criteria:
Inclusion Criteria:

* Screening delirium by all patients
* Measuring of guide line adherence for all professionals working on the ICU
* Implementation guideline: all professionals

Exclusion Criteria:

* no
Mesalamine 4 gm/60 mL Rectal Enema

The objective of this study is to evaluate the relative bioavailability of the test formulation of mesalamine suspension rectal enema with the already marketed reference formulation Rowasa® in healthy, adult subjects.

Criteria for Evaluation: FDA Bioequivalence Criteria

Statistical Methods: FDA bioequivalence statistical methods

Eligibility Criteria:
Inclusion Criteria:

* Males and females, 18 years or older, with a body mass index (BMI) of 30 or less.
* Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
* Signed informed consent form, which meets all criteria of current FDA regulations.
* If female and of child bearing potential prepared to abstain from sexual intercourse or use a reliable method of contraception during the study (e.g. condom, IUD, hormonal contraceptives).

Exclusion Criteria:

* If female pregnant, lactating, or likely to become pregnant during the study.
* History of allergy or sensitivity to mesalamine or other salicylic drugs (e.g. aspirin, sulfasalazine) or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
* Colitis, hemorrhoids, anal fissures, or other disease of the anus, rectum or colon.
* Significant history or current evidence of chronic infections disease, system disorder or organ disorder.
* History of psychiatric disorders occuring within the last two years that required hospitalization or medication.
* Presence of a medical condition requiring regular treatment with prescription drugs (other than contraceptives).
* Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to dosing.
* Receipt of any drug as part of a research study within 30 days prior to dosing.
* Drug or alcohol addiction requiring treatment in the past 12 months.
* Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma within 14 days prior to dosing.
* Positive test for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
* Positive test results for drugs of abuse at screening.
* Positive serum pregnancy test at screening.
* Unable or unwilling to tolerate multiple venipunctures.
A Study of CC-99677 in Participants With Active Ankylosing Spondylitis

This study is designed to learn about response to CC-99677 treatment by measuring signs and symptoms of Ankylosing Spondylitis (AS), objective measures of disease activity, quality of life assessments, pharmacokinetics, safety, and tolerability over a 12-week double-blind period.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Ankylosing Spondylitis (AS) fulfilling the modified New York criteria
* Active axial disease at Screening and Baseline defined by a Bath Ankylosing
* Spondylitis Disease Activity Index (BASDAI) score ≥ 4 and Total Back Pain ≥ 4
* Failed prior treatment with at least 2 NSAIDs for at least 4 weeks each
* Participant has never received a biologic therapy eg, tumor necrosis factor (TNF) antagonist or monoclonal antibody \[mAb\] against IL-17A (biologic naive main study), or have taken more than one biologic therapy (biologic-failure substudy) for the treatment of AS

Exclusion Criteria:

* Radiographic evidence of total ankylosis of the spine
* Clinically significant back pain caused by diseases other than AS
* Concurrent treatment or treatment within the 6 months prior to Baseline with cell depleting biologic agents
* Participation in any study of an investigational drug, including those for COVID-19
* History of malignancy
* Oral corticosteroids (prednisone or equivalent) \> 10 mg/day systemically for ≥ 2 weeks prior to Baseline Visit
A Manufacturing Transfer Study Comparing the Bioequivalence of a Single Oral Dose of Claritin-D 12-Hour Extended Release Tablet From 2 Different Manufactuers Under Fed Conditions in Healthy Adult Subjects

To evaluate the bioequivalence of one extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer HealthCare LLC by SAG Manufacturing, S.L.U. Madrid, Spain (test treatment) to the extended release combination (loratadine 5 mg/pseudoephedrine sulfate 120 mg) tablet manufactured for Bayer SA-NV by Schering- Plough Labo NV Heist (reference treatment) which is currently marketed in Europe.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult men or women
* Age 18 to 55 years inclusive
* Body mass index 18.5 to 30.0 kg/m\*2 inclusive
* Be willing and able to consume all contents of the standardized breakfast within 30 minutes of dosing

Exclusion Criteria:

* Positive alcohol or drug screen at Screening or on Day -1 of each dosing period;
* Use of within 1 month before first study drug administration, systemic or topical medicines or substances which might affect the study objectives, any drug known to induce cytochrome P3A4/5 or P Glycoprotein (e.g., rifampin, carbamazepine, St. John's wort); Any drug known to inhibit cytochrome P3A4/5 or P Glycoprotein (e.g., clarithromycin, chloramphenicol, ketoconazole);
* History of hypersensitivity symptoms with the use of loratadine, desloratadine (Clarinex), or pseudoephedrine;
* Females who are pregnant or lactating
* Known severe allergies (e.g., allergies to more than 3 allergens, allergies affecting the lower respiratory tract - allergic asthma, allergies requiring therapy with corticosteroids);
* More than moderate alcohol consumption (\>40 g of alcohol regularly per day);
* Any history or suspicion of barbiturate, amphetamine, benzodiazepine, cocaine, opiates, methamphetamine or cannabis abuse;
* Loss of blood of 50 mL to 499 mL within 30 days of the first dose of trial treatment, or in excess of 500 mL within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis or injury)
PET Scan Combined With CT Scan in Evaluating Treatment Response in Patients Undergoing Treatment for Bone Cancer or Soft Tissue Sarcoma

RATIONALE: Diagnostic procedures, such as PET scan and CT scan, may help doctors determine the extent of cancer and predict a patient's response to treatment and help plan the best treatment.

PURPOSE: This clinical trial is studying how well PET scan combined with CT scan evaluates treatment response in patients undergoing treatment for bone cancer or soft tissue sarcoma.

OBJECTIVES:

* Determine whether an FDA-approved device that combines fludeoxyglucose \^18F positron-emission tomography (FDG-PET) and CT scanning (FDG-PET/CT) can accurately locate and determine the extent of disease in patients who are undergoing treatment for bone or soft tissue sarcoma.
* Determine whether FDG-PET/CT scanning is effective in evaluating the response of sarcoma to treatment.
* Determine whether the new FDG-PET/CT device improves the ability to evaluate treatment response early and accurately.
* Correlate changes in glucose metabolic activity early and late after treatment with overall and progression-free survival.
* Correlate changes in glucose metabolic activity early and late after treatment with degree of tumor necrosis at the time of surgery.

OUTLINE: This is a prospective, pilot study. Patients are stratified according to disease (high-grade soft tissue sarcoma vs low-grade soft tissue sarcoma vs osteosarcoma).

Patients undergo fludeoxyglucose \^18F positron-emission tomography (FDG-PET)/CT scanning at baseline and then within 2 weeks and 12 weeks after the start of treatment (total of 3 scans).

PROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed bone or soft tissue sarcoma
* Scheduled to undergo treatment (i.e., chemotherapy and/or radiotherapy) for sarcoma
* Negative pregnancy test
* Fertile patients must use effective contraception
* Not claustrophobic
* Able to lie supine for 1 hour
* Patients with diabetes mellitus allowed provided serum glucose levels ≤ 200 mg/dL

Exclusion Criteria:

* pregnant
* other malignancies within the past 5 years (except completely resected cervical or nonmelanoma skin cancer) unless the malignancy was curatively treated and is at low risk for recurrence
A Study of Itraconazole in the Management of Superficial Fungal Infections in India

The purpose of this study is to estimate the proportion of participants prescribed itraconazole for Tinea cruris or Tinea corporis who have clinical response after 7 days of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed with Tinea cruris or Tinea corporis with or without history of treatment
* Are prescribed itraconazole at 200 milligram/day orally for the treatment of T. cruris or T. corporis and taken once a day
* A woman of childbearing potential must have a negative highly sensitive serum (beta human chorionic gonadotropin \[beta hCG\]) at screening on Day -3 to 0 before start of study drug
* A woman must be (a) not of childbearing potential (b) of childbearing potential and: Practicing a highly effective method of contraception (failure rate of less than \[\<\] 1 percentage \[%\] per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study drug and until 30 days after last dose (that is, the end of relevant systemic exposure)
* A male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person. A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last dose of study drug

Exclusion Criteria:

* History of ventricular dysfunction such as congestive heart failure (CHF) or receiving treatment for CHF, liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances at any time prior to the start of study
* Known achlorhydria or on treatment of gastric acidity
* Presence of other dermatoses, example. psoriasis, seborrhoeic or atopic dermatitis
* Infected with organism with known or established resistance to itraconazole
* Co-existing fungal infection of other body area
Age-related Clonal Haematopoiesis in an HIV Evaluation Cohort (ARCHIVE)

The ARCHIVE study is an observational longitudinal cohort study of people with and without HIV who are over the age of 55. The duration of the study is planned for 10 years, with study visits every 1-2 years. The objectives of the study are to evaluate genomic and other factors associated with aging, stratified by HIV status.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged \>55
* For participants without HIV: an HIV negative test within 12 months prior to enrolment. If no HIV-negative test result is available within 12 months prior to enrolment, then participants will be tested for HIV as part of standard of care, if indicated by the guidelines for HIV testing published by the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine14. This study will not conduct HIV testing; therefore, any participants without HIV being considered for participation in the study will need to have had a standard of care HIV negative test within the past 12 months. Some subjects at on-going risk for HIV are recommended to have periodic HIV testing and may be due for such testing as part of standard of care, at the time of enrolment into the study.
* Willing and able to provide written informed consent and willingness to participate in and comply with a longitudinal cohort study including 1) consent to providing blood samples for full blood count, inflammatory marker testing and genomics analysis 2) consent to linking their data to national and state-wide data registries (including consent to providing personally identifying information); and 3) consent to participate in future follow-up studies

Exclusion Criteria:

- Unwilling or unable to provide consent to participate
Dutch Acute HCV in HIV Study (DAHHS)

Prospective open label proof of concept feasibility interventional clinical trial in which 60 acute HCV genotype 1 patients co-infected with HIV will receive 12 weeks of boceprevir in addition to Standard Of Care Peginterferon + Ribavirin if they show a Rapid Viral Responds at week 4.

The primary hypothesis of this study is that the subset of patients with a Rapid Viral Responds after 4 weeks of triple therapy with boceprevir, peginterferon alpha-2b (P) and ribavirin (RVR4) can be successfully treated with a shorter 12-week triple therapy regimen.


Eligibility Criteria:
Inclusion Criteria:

1. Documented recent HCV genotype 1 infection (≤26 weeks old at the time of the baseline visit) according to definition mentioned below.
2. Plan to start a Standard Of Care therapy for acute HCV consisting of 24 weeks of Peginterferon + Ribavirin. HCV RNA plasma viral load at screening \>1000 IU/ml.
3. A previously performed HCV RNA plasma measurement can be used for screening if \<4 weeks old.
4. On HAART at the time of screening.
5. Minimum age 18 years.

Exclusion Criteria:

1. Disallowed co-medication that cannot be stopped or replaced: Several potentially life-threatening drug-drug interactions (DDI) are possible when boceprevir is combined with other drugs. Therefore ALL co-medication, including over-the-counter drugs should be checked for potential DDI with DDI table in the Dutch summary of product characteristics (SPC, appendix A). If the co-medication is not mentioned in the SPC DDI table, www.HCV-druginteractions.org should be used.
2. Contraindications for the use of full dose of peginterferon alpha-2b or ribavirin: neutrophils \<0,75×109/l or thrombocytes \< 100.000×109/l or a Hb \<6.2mmol/L, creatinine clearance \<50ml/min).
3. History of liver cirrhosis or \>F1 fibrosis on fibroscan. Inclusion of patients with a chronic well-controlled HBV (HBV-DNA below the limit of detection) with tenofovir, lamivudine or emtricitabine therapy is allowed if fibroscan excludes \>F1 fibrosis. Fibroscan reports \<2 years old can be used for screening. Fibroscan is not required for other patients at screening.
4. HAART was started \<4 weeks before baseline visit.
5. Inability to switch to a HAART regimen consisting of 2 nucleoside/tide reverse transcriptase inhibitors + Raltegravir (Isentress®) 400mg BID or rilpivirine 25mg QD or atazanavir (Reyataz®) 300mg QD + ritonavir (Norvir®) 100mg QD.
6. Patient that virologically failed HAART in the past
Computer Adaptation of Screening, Brief MET Intervention to Reduce Teen Drinking

The goal of this project is to evaluate the feasibility, acceptability, and effect size of a new computerized Motivational Enhancement Therapy (cMET) intervention for alcohol-involved adolescents in primary care.

The study aims are to:

1. Assess cMET feasibility and acceptability and estimate its effect size on underage drinking. Hypothesis: Among 14- to 20-yr-old primary care patients, those receiving cMET will have lower rates of any alcohol use, days of alcohol use, drinks per drinking day, and days of heavy episodic drinking, than those receiving treatment as usual.
2. Estimate effect sizes for tobacco, cannabis, and other drug use, and other substance-related risks and outcomes including substance-related driving/riding, and experience of substance-related problems.
3. Identify potential moderators and mediators of cMET's effect.

Eligibility Criteria:
Inclusion Criteria:

* 14- to 20- yr-olds
* arriving for routine care to one of our participating pediatric practices (Lexington Pediatrics, Lexington, MA; East Boston Community Health Center, Longwood Pediatrics, Tufts Medical Center Adolescent Clinic, Boston, MA; Cambridge Health Alliance Dept. of Pediatrics, Cambridge, MA)
* any alcohol use days in the past 90 days,
* have an email address and internet access at home, school, or library
* provide informed assent/consent.

Exclusion Criteria:

* unable to read or understand English,
* living away at college at the time of the recruitment visit,
* not available for computer/telephone follow-ups,
* judged by the provider to be medically or emotionally unstable at the time of the visit.
Association Between Chronic Headache and Back Pain With Childbirth

This study uses a single questionnaire to evaluate two separate primary outcomes:

1. To identify association between chronic headache in women who have given birth to children as compared to a control group of women who have raised children but have not given birth to them
2. To identify association between chronic back pain in women who have given birth to children as compared to a control group of women who have raised children but have not given birth to them

Chronic headache and back pain have an excess prevalence in women as compared to men. This study uses a single survey that uses logic to assess for association between childbirth and chronic headache and between childbirth and chronic back pain using screening questions. The questions are, "Do you suffer from chronic headaches" and "Do you suffer from chronic back pain". Depending on the answer to the screening question, the subject will be given further questions only related to the syndrome that they endorsed.

Arm 1) There is an association between chronic headache and childbirth over and above raising children. Secondary outcomes are temporal association between onset or worsening of headache and childbirth, association between migraine headache and childbirth, association between chronic headache and anesthetic complications.

Arm 2) There is an association between chronic back pain and childbirth over and above raising children. Secondary outcomes are temporal association between onset or worsening of back pain and childbirth, association between chronic headache and anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Female representation

Exclusion Criteria:

* None