cyrilzakka/clinical-trials huggingface dataset:
BCMA-targeted LCAR-BCDR Cells in Patients With Relapsed/Refractory Multiple Myeloma

This is a prospective, single-arm, open-label, dose-finding and dose-expansion study that evaluates the safety, tolerability, PK, and anti-tumor efficacy of LCAR-BCDR cell preparations in relapsed/refractory multiple myeloma subjects who received adequate standard therapy.


Eligibility Criteria:
Inclusion Criteria:

1. The subject voluntarily participates in the clinical study; Fully understand and be Informed of the study and sign the Informed consent (Informed Consent Form, ICF); Willing to follow and able to complete all test procedures; Informed consent must be obtained before initiating any tests or procedures related to the study that are not part of the standard treatment of the subject's disease;
2. Subjects ≥ 18 years of age.
3. Documented initial diagnosis of MM according to IMWG diagnostic criteria.
4. Presence of measurable disease at screening.
5. Received a PI and an IMiD (except thalidomide).
6. Received at least 3 prior lines of therapy for multiple myeloma, undergone at least 1 complete cycle of treatment for each line, unless progressive disease (PD) was documented by IMWG criteria as the best response to the regimen. Also, subjects refractory or intolerant to any PI and any IMiD in their previous treatment afterwards are eligible.
7. Expected survival ≥ 3 months.
8. Clinical laboratory values meet screening visit criteria
9. Fertile women must be negative using a highly sensitive serum pregnancy test (β human chorionic gonadotropin \[β -HCG\]) at screening time and before initial treatment with cyclophosphamide and fludarabine;

Exclusion Criteria:

1. No response to prior BCMA-targeted CAR-T therapy (except in subjects who relapsed after CR to prior CAR-T treatment).
2. Prior treatment with any antibody targeting BCMA.
3. Diagnosed or pretreated for an invasive malignancy other than multiple myeloma.
4. Prior anti-tumor treatment (before pretreatment) with insufficient washout period.
5. Known active, or prior history of central nervous system (CNS) involvement, or clinical signs of membrane/spinal membrane involvement of multiple myeloma.
6. Positive of any hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV DNA), hepatitis C antibody (HCV-Ab), hepatitis C virus ribonucleic acid (HCV RNA), human immunodeficiency virus antibody (HIV-Ab) at the time of screening.
7. Serious underlying medical conditions
8. Male subjects who have a birth plan during the study period or within 1 year after the study treatment.
9. Female subjects who are pregnant, breast-feeding, or plan to become pregnant during the study period or within 1 year after the study treatment.
10. The investigator considered that the subjects were not suitable for any conditions of participation in the study.
Efficacy and Safety of Vatelizumab in Patients With Relapsing-Remitting Multiple Sclerosis

Primary Objectives:

* To assess the efficacy of vatelizumab compared to placebo as measured by a reduction in new contrast-enhancing lesions (CELs) in relapsing remitting multiple sclerosis (RRMS) patients.
* To evaluate multiple doses of vatelizumab for a dose-response.

Secondary Objectives:

* To evaluate the safety and tolerability of vatelizumab compared to placebo.
* To evaluate the pharmacokinetics (PK) of vatelizumab.

The duration of study per patient will be up to 108 weeks, including a screening period of up to 4 weeks, a treatment period of 12 weeks and a post-treatment safety follow-up period of up to 92 weeks.

Patients completing the 12-week treatment period may enter an optional long-term extension study in which all subjects will receive vatelizumab.

Eligibility Criteria:
Inclusion criteria:

Diagnosis of relapsing-remitting multiple sclerosis (RRMS). At least 1 documented relapse in the past 12 months. At least 1 contrast-enhancing lesion (CEL) on magnetic resonance imaging (MRI) in the past 12 months and/or at screening.

At least 3 T2 lesions on screening MRI.

Exclusion criteria:

Diagnosis of primary progressive or secondary progressive MS. Expanded disability status scale (EDSS) score \>5.5. Relapse within 30 days prior to enrollment. Prior immunosuppressive treatment within protocol-specified time periods. Prior treatment with natalizumab (Tysabri®). History of bleeding/platelet disorders, malignancy, certain infections as defined in the protocol, or any other past or current medical conditions that would adversely affect the patient's participation in the study.

Pregnancy or breast-feeding. Other protocol-defined inclusion/exclusion criteria may apply.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Assesment of Hearing in Patients With Vestibular Migra

Evaluation of hearing in patients with vestibular migraine


Eligibility Criteria:
Inclusion Criteria:

* vertigo

Exclusion Criteria:

* hypertension
Use of Palliative Performance and Symptom Distress Scales in Older Patients With Advanced Ovarian Cancer

RATIONALE: Measuring changes in performance status and symptoms distress in patients with cancer may help doctors predict how patients will respond to treatment, and may help the study of cancer in the future.

PURPOSE: This clinical trial is studying changes in performance status and symptoms distress in older patients with advanced ovarian epithelial cancer undergoing surgery and/or chemotherapy.

OBJECTIVES:

Primary

* To evaluate the changes in performance status and symptom distress in older patients with presumed or advanced ovarian cancer undergoing surgery and/or chemotherapy.

Secondary

* To explore the association between these changes with chemotherapy drug change, dose reduction, or dose delay due to toxicity in these patients.
* To explore the association between these changes with the development of surgical complications in these patients.
* To observe the response in the Geriatric Assessment (GA) and report the individual item scores.

OUTLINE: Patients complete the Palliative Performance Scale and the McCorkle Symptom Distress Scale questionnaires at baseline, at 10-20 days after surgery\*, at 14-21 days after courses 3 and 6 of chemotherapy ( if applicable), and at approximately 2-3 months at the patient's first follow-up visit. The research team completes the Professional Geriatric Assessments. Patients' medical records are also reviewed for any surgical complications, chemotherapy toxicities, dose reductions or delays, or change in medications secondary to chemotherapy toxicities.

NOTE: \*Patients who complete the assessments and questionnaires at baseline but who are found not to have ovarian cancer during surgery will remain eligible for assessment of surgical complications.

Eligibility Criteria:
Inclusion Criteria:

* Clinical findings highly suggestive of advanced ovarian epithelial cancer undergoing surgery for definitive diagnosis and staging
* ≥ 65 years of age

Exclusion Criteria:

* Prior diagnosis of ovarian cancer
* Inability to read and speak English
* Inability to comply with study requirements
Refinement and Assessment of New MRI Technologies for Thoracic/ Cardiovascular Exams

The purpose of the study is to improve chest MRI exams, eventually resulting in improvements in patient care.

We will recruit patients to participate in the assessment of new MRI technologies designed to improve chest MRI exams that will result in improvements in patient care.

Several different MRI technologies will be evaluated. Specific evaluation of distinct technologies (eg. new head coil design, and new imaging sequence for the spine) may be evaluated simultaneously, or over non-overlapping periods in time.

Eligibility Criteria:
Inclusion Criteria:

* If you are a male or a non-pregnant female patient, age 18 years or older, of any ethnic background presenting to MRI for a clinically-ordered chest MRI exam, you are eligible to participate in this study.
* If you are a female of child bearing potential you will be questioned for the possibility of pregnancy. Pregnancy screening, if necessary, is performed routinely by ordering physicians prior to MRI scanning to confirm the patient is not pregnant.

Exclusion Criteria:

* Patients who have electrically, magnetically or mechanically activated implants such as heart pacemaker, magnetic surgical clips, prostheses or implanted neurological stimulator.
* Pregnant patients or patients who are nursing
* Patients who are claustrophobic.
A Clinical Study of JS005 in Patients With Ankylosing Spondylitis

This is a multicentre, randomized, double-blind, parallel, placebo-controlled Phase II clinical study of 261 adults with active ankylosing spondylitis to evaluate the efficacy and safety of JS005 in the treatment of active ankylosing spondylitis.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects voluntarily particpate in this clinical study and sign the informed consent form.
2. Male and female patients aged 18-75 years at the time of screening (both inclusive)
3. Meet the diagnosis of active Ankylosing Spondylitis(AS), have a record of radiological evidence consistent with the Modified New York Classification Criteria for ankylosing spondylitis as revised in 1984 4. Diagnosis of active AS (active AS is defined as: BASDAI \>= 4, total back pain score \>=4, and BASDAI second question spinal pain score \>=4)

Exclusion Criteria:

1. Pregnant or lactating women.
2. Active diseases that may confound the evaluation of JS005: other autoimmune inflammatory diseases (including but not limited to systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis, vasculitis, etc.) or chronic pain other than ankylosing spondylitis (including but not limited to fibromyalgia, osteoarthritis, etc.).

4. Active inflammatory bowel disease within 6 months prior to randomization. 5. Recurrent anterior uveitis or acute anterior uveitis within the last 4 weeks prior to randomization.

6. History or evidence of active or latent tuberculosis (TB), defined as a positive interferon gamma release assay (IGRA) or purified protein derivative (PPD) at the time of screening. 7. Positive hepatitis B virus test result 8. Prior exposure to JS005 or any other biologic that directly targets IL-17 or the IL-17 receptor.

9. use of \>= 2 TNF-α inhibitors.
Hepatocellular Carcinoma in HIV-infected Patients

Observational study. All HIV-infected patients who have been diagnosed of hepatocellular carcinoma (HCC), following the American Association for the Study of Liver Diseases (AASLD) criteria, in the participant centers are included. Epidemiological, clinical and laboratory data are collected. The clinical and epidemiological characteristics of HCC cases will be analyzed. The efficacy and outcomes after modalities of HCC therapy will be assessed. Mortality and its predictors will be also assessed. In those cases infected by hepatitis C virus (HCV), the impact of HCV therapy on outcomes will be analysed.


Eligibility Criteria:
Inclusion Criteria:

* HIV infection
* Diagnosis of hepatocellular carcinoma according to American Association for the Study of Liver Diseases (AASLD) criteria

Exclusion Criteria:

* None
Acid Base Balance of ICU Patients With Severe Hypoalbuminemia, Before and After an Albumin Infusion, Using Stewart Approach

The primary purpose was to describe the acid base balance of ICU patients with severe hypoalbuminemia using Stewart's approach for acid base disorders, before and after an human albumin perfusion.

Prospective study, for ICU patient with severe hypoalbuminemia \< 20g/L, determining biological parameters from Stewart approach for acid base disorders (pH, SIDe, SIDa, SIG, Atot, PaCO2) before, and at 1hour, 2hours and 24 hours after a 200mL 20% human albumin perfusion (the consensus conference ANAES of 1995 recommands to correct hypoalbuminemia below 20g/L).

Clinical parameters (respiratory, haemodynamic, neurologic) were also collected at the same times.

Eligibility Criteria:
Inclusion Criteria:

* serum albuminemia \< 20g/L
* adult ICU patient
* Arterial line

Exclusion Criteria:

* albumin allergy
* pregnancy
* congestive heart failure
Single Rising Dose Study of BI 144807 Powder in Bottle in Healthy Male Volunteers

This first-in-man trial forms the basis for potential clinical development of BI 144807 in the indications of asthma and allergic rhinitis. The safety, tolerability, pharmacokinetics, and pharmacodynamics of single rising doses of BI 144807 will be assessed in healthy male volunteers.


Eligibility Criteria:
Inclusion criteria:

1. healthy male subjects

Exclusion criteria:

1. any relevant deviation from healthy conditions
Riluzole in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery

RATIONALE: Riluzole may stop or slow the growth of tumor cells and may be an effective treatment for melanoma.

PURPOSE: This phase II trial is studying how well riluzole works in treating patients with stage III or stage IV melanoma that cannot be removed by surgery.

OBJECTIVES:

Primary

* Determine whether administration of a daily dose of riluzole results in tumor shrinkage, as measured by RECIST criteria, in patients with advanced melanoma.

Secondary

* Determine the long-term toxicity of riluzole when administered to these patients.
* Compare the survival of these patients with historical controls.

OUTLINE: Patients receive oral riluzole twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed malignant melanoma

  * Unresectable stage III or stage IV disease
* Measurable disease according to RECIST criteria, defined as ≥ 1 unidimensionally measurable lesion \> 20 mm by conventional techniques or \> 10 mm by spiral CT scan
* No known brain metastases unless treated and stable for ≥ 2 weeks by MRI evaluation

PATIENT CHARACTERISTICS:

* ECOG performance status 0-2
* ANC ≥ 1,000/μL
* Platelet count ≥ 50,000/μL
* Total bilirubin ≤ 2 times upper limit of normal (ULN)
* AST/ALT ≤ 3 times ULN
* INR ≤ 1.5 times ULN
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 2 weeks after completion of study treatment
* No second primary malignancy, except carcinoma in situ of the cervix, adequately treated nonmelanoma carcinoma of the skin, or other malignancy treated ≥ 5 years ago with no evidence of recurrence
* No concurrent serious systemic disorders (including active infections) that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study
* No history of allergic reactions attributed to riluzole
* No known history of hepatitis B or C

PRIOR CONCURRENT THERAPY:

* No more than 1 prior therapeutic chemotherapy regimen for advanced melanoma
* Prior treatment with riluzole on clinical trial CINJ-090603 allowed
* No other concurrent investigational or commercial agents or therapies for the treatment of the malignancy
EPIX, a Study to Gather More Information About Characteristics of Patients and Other Factors Which May Contribute to Survival Over a Long Period of Time in Patients With Metastatic Castration-resistant Prostate Cancer (mCRPC) Treated With Radium-223 (Xofigo)

In this observational study researchers want to gather more information about the characteristics of patients treated with Radium-223 (Xofigo) who had survived over a long period of time prostate cancer that had spread to other places in the body and keeps growing even when the amount of testosterone in the body is reduced to very low levels (metastatic castration-resistant prostate cancer, mCRPC). In addition researchers want to identify the factors which may contribute to survival over a long period of time in those patients. Radium-223 (Ra-223) is an alpha particle-emitting radioactive agent approved for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC).


Eligibility Criteria:
Inclusion criteria

* Adult patients with documented diagnosis of mCRPC (≥18 years at diagnosis), and
* Received Ra-223 as one of the therapies between Jan 1, 2013 and Jun 31, 2019 after diagnosis of mCRPC

Exclusion criteria

- Patients involved in clinical trials
EEG Results of Deep TMS in Patients With OCD

Obsessive Compulsive Disorder (OCD) is a psychiatric disorder in which involuntary thoughts and irresistible behaviors are seen and its prevalence affects 2%-3% of the general population. Deep TMS is a treatment method that provides stimulation of lower parts of the brain and larger brain volume, and in addition to drug treatment and psychotherapy approaches, magnetic stimulation of localized brain regions and disease symptoms are addressed. The presence of the medial prefrontal cortex and anterior cingulate cortex in the dysfunction on the specified cycle seen in OCD patients indicates that the stimulation of these regions is necessary for a meaningful result in the treatment of deep TMS; studies show that the effect of the deep TMS method emerges as a result of the stimulation of these regions. 30 patients with OCD will included into the study and dividen into 3 groups (DTMS (n=10), DTMS + Paroxetine (n=10), Control(n=10)). Patients will evaluated in terms of depression, quality of life, and EEG before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with Obsessive Compulsive Disorder within the framework of DSM-5 criteria

Exclusion Criteria:

* Not volunteering to comply with the research program
* Presence of a metal piece on the head
* Having a pacemaker inserted
* Having had a previous epileptic seizure
Liraglutide Effects on Memory in Healthy Subjects

This study examines the hypothesis, that subcutaneous administration of liraglutide, an analogue of the incretin glucagon-like peptide 1, over 5 weeks improves memory functions in healthy humans.


Eligibility Criteria:
Inclusion Criteria:

* Male sex
* Age 18-35 years
* Body mass index between 19 and 25 kg/m2
* Non-smoker

Exclusion Criteria:

* Receipt of any drug within 4 weeks prior to this trial
* Any known acute or chronic disease of the brain, heart, lung, kidney,liver, pancreas or gastrointestinal tract, any metabolic, endocrine or psychiatric disease.
* Brady- and Tachycardia, i.e. heart rate \< 50 and \> 90 beats per minute.
* Hypertension (systolic blood pressure \> 150 mmHg, diastolic blood pressure \> 90 mmHg).
* Hyperlipidemia (cholesterol, LDL, triglyceride \> two times the upper reference limit based on analysis from the central laboratory)
* Impaired hepatic function measured as alanine aminotransferase (ALAT) \> two times the upper reference limit based on analysis from the central laboratory
* Impaired renal function measured as creatinine \> 120 µmol/l based on analysis from the central laboratory
* Family history of diabetes
* History of any eating disorder
* Known or suspected allergy to trial products
* History of drug or alcohol abuse within the last five years prior to screening
The Findings of Magnetic Resonance Imaging in Subtypes of Tics-related Disorders

The findings of resting-state functional magnetic resonance imaging and diffusion spectrum imaging in subtypes of tics-related disorders


Eligibility Criteria:
Inclusion Criteria:

* Age less than 18 years old
* Diagnosed as Tourette syndrome or chronic tic disorders

Exclusion Criteria:

* History of neuropsychiatric disorders
* Already receive treatment for Tourette syndrome/chronic tics disorder
* Have some device not allowed for MRI scan
One Piece Drainable Pouch in Subjects With an Ileostomy

To assess the safety and performance of an enhanced one piece drainable pouch in subjects with an ileostomy.

This is a pre market study to assess safety and performance of a one piece drainable pouch. Twelve subjects will be recruited and will use the study pouch for 10 days. During this time data on skin and stoma condition will be collected along with questions related to ease of use comfort and overall pouch performance. The study will be conducted in the US in one single site.

Eligibility Criteria:
Inclusion Criteria

1. Of legal consenting age and able to provide written informed consent
2. Is able to read, write, and understand the primary language of the investigative site.
3. Have an ileostomy for more than 3 months
4. Currently a one or two piece drainable pouch user (all attempts will be made to include ConvaTec Active Life or Esteem Plus one piece closed pouch users)
5. Have unbroken peri-stomal skin (healthy normal skin to L1 on the SACs Instrument Scale # 1)
6. Have a stoma considered 'normal' in appearance in accordance with the stoma, color, moisture and structure rating scales
7. Be willing to wear a one piece drainable pouch with moldable wafer according to the usual wear pattern of this type of pouch
8. Be willing to participate in the trial for 10 days plus 1 visit prior to the in-residence study period.
9. Be willing to remain in residence for 3 days at a central location
10. Be willing to meet with the investigator for a total of nine scheduled visits.
11. Be willing to discontinue the use of pastes, adhesive strips and rings/seals used to seal the area between the skin barrier wafer and stoma during the use of the study device
12. Other than their ileostomy considered to have a healthy/stable health status Have good manual dexterity and be able to take care of their stoma independently Be willing and able to complete a diary card for the duration of the study. Be willing to take photographs of the stoma and pouch on pouch removal

Exclusion Criteria - The following subjects must not be included into the study:

1. Subjects with a history of sensitivity to any one of the ostomy products or the components being studied
2. Subjects with stoma duration of less than 3 months
3. Subjects who currently use a belt with their usual appliance
4. Subjects who have been entered into the study before, or who have previously taken part in a study in the last month.
5. Subjects who require convexity or other skin fillers (pastes, seals, or rings) to even undulations of the peristomal skin
6. Subjects undergoing chemotherapy or radiotherapy
7. Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study
A Study of Once Monthly Subcutaneous Mircera in Dialysis Patients With Chronic Renal Anemia

This single arm study will assess the efficacy, safety and tolerability of once monthly administration of subcutaneous Mircera for the maintenance of hemoglobin levels in dialysis patients with chronic renal anemia. Patients will receive subcutaneous Mircera at a starting dose of 120, 200 or 360 micrograms every 4 weeks, calculated from the last weekly dose of epoetin or darbepoetin alfa previously administered. Subsequent doses will be adjusted to maintain hemoglobin levels within the target range. Treatment duration is 56 weeks, and the target sample size is 200 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients \>=18 years of age;
* chronic renal anemia;
* regular long-term hemodialysis or peritoneal dialysis, with same mode of dialysis for \>=3 months;
* continuous iv maintenance epoetin alfa therapy with same dosing interval during previous 2 months.

Exclusion Criteria:

* transfusion of red blood cells during previous 2 months;
* poorly controlled hypertension;
* significant acute or chronic bleeding;
* active malignant disease (except non-melanoma skin cancer).