cyrilzakka/clinical-trials huggingface dataset:
Study Evaluating the Safety and Efficacy of JWCAR029 in Adult Subjects With Relapsed and Refractory B-cell Non-Hodgkin Lymphoma

This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infusion of autologous CD19-targeted chimeric antigen receptor (CD19 CAR) T cells in adult subjects with relapsed and refractory B-cell Non-Hodgkin lymphoma.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must meet all of the following criteria to be enrolled in this study:

  1. Age ≥ 18 years at the time of consent
  2. Signed written informed consent obtained prior to any study procedures
  3. Relapsed or refractory B-cell NHL.
  4. PET-positive disease BY Lugano classification
  5. Archived tumor biopsy tissue available from the last relapse and corresponding pathology report available or, if at least one tumor-involved site is deemed accessible at time of screening, willing to undergo pre-treatment biopsy (excisional when possible) for disease confirmation. If a subject has never had a complete response, a sample from the most recent biopsy is acceptable.
  6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  7. Adequate bone marrow, renal, hepatic, pulmonary and cardiac function
  8. Adequate vascular access for leukapheresis procedure
  9. Subjects who have received previous CD19-targeted therapy must have CD19-positive lymphoma confirmed on a biopsy since completing the prior CD19-targeted therapy
  10. Subjects must agree to use appropriate contraception.

Exclusion Criteria:

* Subjects who meet any of the following criteria will be excluded from participation in this study:

  1. Subjects with central nervous system (CNS)-only involvement by malignancy (note: subjects with secondary CNS involvement are allowed on study)
  2. History of another primary malignancy that has not been in remission for at least 2 years.
  3. Treatment with alemtuzumab within 6 months of leukapheresis, or treatment with fludarabine or cladribine within 3 months of leukapheresis
  4. Active hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection at the time of screening
  5. Subjects with uncontrolled systemic fungal, bacterial, viral or other infection despite appropriate antibiotics or other treatment at the time of leukapheresis or JWCAR029 administration
  6. Presence of acute or chronic graft-versus-host disease (GVHD)
  7. History of cardiovascular disease
  8. History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
  9. Pregnant or nursing women.
  10. Prior CAR T-cell or other genetically-modified T-cell therapy, with the exception of prior JWCAR029 treatment in this protocol for subjects receiving retreatment
The Effect of Endotracheal Tube With Stylet in Morbidly Obese Patients

The investigators aimed to compare the effects of using enotracheal tube with stylet versus endotracheal tube alone in morbidly obese patients undergoing sleeve gastrectomy.

Different intubation techniques have been used in morbidly obese patients undergoing general anesthesia. No study comparing the use of endotracheal tube with or without stylet was found in literature. Thus, the investigators aimed to compare the effects of using enotracheal tube with stylet versus endotracheal tube alone in morbidly obese patients undergoing sleeve gastrectomy.

Eligibility Criteria:
Inclusion Criteria:

Body mass index over 30 ASA physical status I-III Undergoing laparoscopic sleeve gastrectomy -

Exclusion Criteria:

Body mass index under 30 ASA physical status IV Unable to cooperate Refused to give writtten informed consent-
Timing Carotid Stent Clinical Study for the Treatment of Carotid Artery Stenosis（Timing Trial）

Evaluate the safety and efficacy of the Timing Carotid Stent for the treatment of carotid artery stenosis in patients.

This is a prospective, randomized, concurrent controlled, multi-center study. Patients with carotid artery stenosis will be assigned to either the Timing Carotid Stent or Carotid Wallstent. Each treated patient will be followed and assessed for 12 months after randomization. The hypothesis to be tested is that the safety and effectiveness of the Timing Carotid Stent is not inferior to the Carotid Wallstent.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-85 years;
2. Patient is either symptomatic with carotid stenosis ≥50% OR asymptomatic with carotid stenosis ≥70% ;
3. Target lesion 3.5- 5.5 mm;
4. Signed informed consent.

Exclusion Criteria:

1. Target lesion is not caused by atherosclerotic disease；
2. Target lesion is located at the opening of the common carotid artery；
3. Patient has severe lesion calcification that may restrict the full deployment of the carotid
4. Patient has a total occlusion of the target carotid arteries
5. Patient has a large number of acute or subacute thrombi and arteriovenous malformations near the target lesion
6. Patient has a severe stenosis or occlusion in series with target lesions
7. Patient has known severe carotid stenosis contralateral to the target lesion
8. Patient need angioplasty in other parts (including intracranial and extracranial) at the same time or within 30 days after procedure
9. Patient has a symptomatic severe stenosis of other blood vessels (including intracranial and extracranial) except carotid artery
10. Patient is experiencing (or has experienced) an evolving, acute, or recent disabling stroke or intracranial hemorrhage
11. Patient has a massive stroke or myocardial infarction
12. Patient has a intracranial aneurysm
13. Patient has a coagulation dysfunction or abnormal bleeding, or contraindications to heparin and antiplatelet drugs
14. Patient has known sensitivity to contrast agent
15. Patient has a platelet \< 90 × 109 / L, severe liver and kidney injury, and severe dysfunction of important organs such as heart, lung, liver and kidney
16. Patient has a uncontrollable severe hyperemia
17. Patient has a bradycardia
18. mRS≥3
19. Patient has life expectancy of less than one year
20. Patient is currently enrolled in another investigational study protocol
21. Females who are pregnant or in lactation
22. Other conditions not suitable for inclusion judged by the researcher -
Effects of Diet Selection Based on Genetic Screening on Success to a Weight Loss Program

The purpose of this study is to determine the effects of diet type selection based on response to a Carbohydrate Intolerance Questionnaire (CIQ) and genetic screening on success to a weight loss and exercise program.

The purpose of this study is to determine if stratification of individuals based on responses to a Carbohydrate Intolerance Questionnaire (CIQ), genetic screening, and/or DNA methylation affects weight loss success and/or health outcomes of women following the Curves moderate carbohydrate, high protein, low fat diet (30% carbohydrate, 45% protein, 25% fat) or the Curves carbohydrate restricted, high protein, moderate fat diet (20% carbohydrate, 45% protein, 35% fat).

Eligibility Criteria:
Inclusion Criteria:

* The participant is an apparently healthy female
* The participant is between the ages of 18 and 60

Exclusion Criteria:

* The participant is pregnant or nursing, or plans to become pregnant during the next 12 months or has been pregnant in the past 12 months
* The participant has uncontrolled metabolic disorder including known electrolyte abnormalities; heart disease, arrhythmias, diabetes, thyroid disease, or hypogonadism; a history of hypertension, hepatorenal, musculoskeletal, autoimmune, or neurological disease
* The participant is currently taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, or androgenic medications
* The participant has taken ergogenic levels of nutritional supplements that may affect muscle mass (e.g., creatine, HMB), anabolic/catabolic hormone levels (androstenedione, DHEA, etc.) or weight loss (e.g., ephedra, thermogenics, etc.) within the past three months
* The participant is willing to take participate in a regular moderate exercise program
Use of Automated Office Blood Pressure Monitoring

Blood pressure measurements by three methods Office Blood Pressure Measurement (OBPM), Automated Office Blood Pressure Measurement (AOBPM), and Home Blood Pressure Measurement (HBPM) were collected retrospectively across three visits for patients (N=28) referred to a specialty hypertension (HTN) clinic. Demographic data were analyzed using summary statistics. The differences between AOBPM, HBPM, and OBPM were examined using mixed models repeated measures analysis for time and method for each visit.


Eligibility Criteria:
Inclusion Criteria:

* 19 years and older
* Uncontrolled BP
* Prescribed three or more antihypertensive medications at the time of referral
* Higher risk for poor CV outcomes than patients with essential HTN
* OBPM systolic BP of greater than 140 mmHg and diastolic BP of greater than or equal to 90 mm Hg upon initial clinic assessment.

Exclusion Criteria:

* Less than 19 years old
* Had a systolic BP of less than 140 mm Hg and diastolic BP of less than 90 mmHg upon initial clinic assessment.
* Also, patients on less than three antihypertensive medications, with less than three visits, and who have controlled OBPM were excluded.
Post Marketing Observational Study (PMOS) to Assess Quality of Life in Swedish Hidradenitis Suppurativa (HS) Patients

The objective of this study is to assess quality of life (QoL), skin pain, work productivity/activity and health related problems in Swedish patients with moderate to severe HS before and after 6 months treatment with Adalimumab. Participants will be treated in accordance with normal routine clinical care.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Hidradenitis Suppurativa
* Prescribed Adalimumab according to the Summary of Product Characteristics (SmPC)
* Willingness to sign and date a Patient Information/Informed Consent Form

Exclusion Criteria:

* Prior biologic treatment discontinued \<6 months before the baseline visit
* Patient not able to understand the language of the provided patient questionnaires
* History of non-compliance with medication or a medical history that could enhance non-compliance with medication, as determined by the investigator
Study of Safety, Tolerability, and Efficacy of Secukinumab in Subjects With Moderate to Severe Palmoplantar Psoriasis

Purpose of the study was to demonstrate the efficacy of secukinumab versus placebo on palmoplantar psoriasis and to assess the long term efficacy, safety and tolerability of secukinumab.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with chronic, moderate to severe plaque type psoriasis for at least 6 months prior to randomization and significant involvement of the palms and soles at baseline, defined as palmoplantar Investigator's Global Assessment (ppIGA) score of ≥ 3 on a 5-point scale, as well as at least one skin plaque at baseline which is not in the palmoplantar area
* Candidates for systemic therapy, i.e. psoriasis inadequately controlled by topical treatment (including super potent topical corticosteroids) and/or phototherapy and/or previous systemic therapy

Exclusion Criteria:

* Forms of psoriasis other than chronic plaque type psoriasis (e.g., pustular psoriasis, palmoplantar pustulosis, acrodermatitis of Hallopeau, erythrodermic and guttate psoriasis)
* Drug-induced psoriasis (e.g. new onset or current exacerbation from β-blockers, calcium channel inhibitors or lithium)
* Ongoing use of prohibited treatments (e.g. topical or systemic corticosteroids (CS), UV therapy). Washout periods do apply.
* Prior exposure to secukinumab (AIN457) or any other biological drug directly targeting IL-17 or the IL-17 receptor
* Use of any investigational drugs within 4 weeks prior to study treatment initiation or within a period of 5 half-lives of the investigational treatment, whichever is longer
* Active ongoing inflammatory diseases other than psoriasis that might confound the evaluation of the benefit of secukinumab therapy
* History of hypersensitivity to constituents of the study treatment
Comparison of Blood Pressure Lowering Effect Between Fimasartan and Losartan

Comparison of blood pressure lowering effect between Fimasartan and Losartan in the hypertensive patient during night and early morning time


Eligibility Criteria:
Inclusion Criteria:

* Subject don't have Anti-hypertensive drug or who stop Anti-hypertensive drug during 2 weeks
* Office BP: over siSBP 140mmHg or si DBP 90mmHg
* 24hr ABPM: SBP 130mmHg or DBP 80mmHg (24 hour Average)

Exclusion Criteria:

* Pregnant, trying to become pregnant or breast feeding
* Subject has Secondary Hypertension
* White coat Blood Pressure (Normal result of 24 hour ABPM)
Efficacy of One or Two Botulinum Toxin Injections in the Treatment of Chronic Lateral Epicondylalgia: a Retrospective Study (EPITOX)

Despite being a self-limiting injury, lateral epicondylitis (LE) can be difficult to manage. In cases of refractory LE, conservative treatment fails and symptoms persist over 6 months. Previous studies have investigated the role of botulinum Toxin Type A (BoNT-A) injections in LE with controversial results. There is some evidence that repeating the BoNT-A injection could be beneficial for refractory cases.

The objective is to assess the success rate of one or two BoNT-A injections for refractory LE.


Eligibility Criteria:
Inclusion Criteria:

lateral epicondylitis at least one botulinum injection

Exclusion Criteria:

* none
Long-term Results After Endoscopic Total Extraperitoneal Repair of Recurrent Inguinal Hernia

Evaluation of long-term results for chronic pain and impairment of daily activities after endoscopic total extraperitoneal repair of recurrent inguinal hernia with inguinal pain questionnaire (IPQ).

Evaluation of long-term results for chronic pain and impairment of daily activities after endoscopic total extraperitoneal repair of recurrent inguinal hernia with inguinal pain questionnaire (IPQ).

All patients, who had a endoscopic preperitoneal mesh repair of a recurrent inguinal hernia between 1995 and 2008 were prospectively recorded and will be sent the IPQ via mail.

Eligibility Criteria:
Inclusion Criteria:

* patients, who had endoscopic total extraperitoneal repair of recurrent inguinal hernia at our institution between 1995 and 2008

Exclusion Criteria:

* none
Assessment of Tele-expertise for Second Medical Opinion on Pathological Diagnosis

The purpose of this study is to determine whether digitalizing pathological slides and let it accessible on a server for a second medical opinion (tele-expertise) would reduce the time to diagnosis.


Eligibility Criteria:
Inclusion Criteria:

* All patients in need for a second medical opinion on a pathological sample

Exclusion Criteria:

* None
The Effects of Mirror-Based Virtual Reality Systems and Recalibration Software on Upper Extremity Function in Individuals Experiencing Hemiparesis Post-Stroke

The goal of this study is to learn about the benefits of using a virtual reality gaming system that can be adjusted for a person who has upper arm weakness from stroke. The main question it aims to answer is whether strength and movement in the upper arm be improved by use of the gaming system.

Participants will be asked to complete initial measurements of upper arm function, play a video game for one hour, four times a week for five weeks, and repeat the measurements of upper arm function at the end.


Eligibility Criteria:
Inclusion Criteria:

* Self-reported diagnosis of stroke
* Greater than 2 years post-stroke
* Access to reliable transportation
* History of weakness/hemiparesis of one upper limb

Exclusion Criteria:

* Significant vision impairment or blindness
* Non-English speaking
* History of seizure or seizure disorder
* Health conditions which would be exacerbated by low-intensity exercise
* Inability to use arms independently for exercise
Ceftobiprole in the Treatment of Patients With Staphylococcus Aureus Bacteremia

The purpose of this study was to compare the efficacy and safety of ceftobiprole medocaril versus a comparator in the treatment of patients with complicated Staphylococcus aureus bacteremia (SAB).

Patients were randomized 1:1 to ceftobiprole or the comparator regimen. Randomization was stratified by study site, dialysis status, and prior antibacterial treatment use within 7 days before randomization.

The three phases of the study were:

1. Screening assessments of up to 72 hours prior to randomization
2. Randomization and subsequent active treatment with intravenous (i.v.) study drug (ceftobiprole or daptomycin ± aztreonam).
3. Post-treatment, comprising an end of trial (EOT) visit (within 72 hours of last study-drug administration), Day 35 (± 3 days), Day 42 (± 3 days), and a post-treatment evaluation (PTE) visit on Day 70 (± 5 days) post-randomization.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age
* Staphylococcus aureus bacteremia (SAB), based on at least one positive blood culture obtained within the 72 h prior to randomization
* At least one of the following signs or symptoms of bacteremia:

  1. fever (e.g.≥ 38 °C/100.4 °F measured orally)
  2. white blood cell count \> 10,000 or \< 4,000 cells/µL, or \> 10% immature neutrophils (bands)
  3. tachycardia (heart rate \> 90 bpm)
  4. hypotension (systolic blood pressure \< 90 mmHg)
* At least one of the following:

  1. SAB in patients undergoing chronic intermittent hemodialysis or peritoneal dialysis
  2. Persistent SAB
  3. Definite native-valve right-sided infective endocarditis by Modified Duke's Criteria
  4. Other forms of complicated SAB
  5. Osteomyelitis (including vertebral, sternal, or long-bone osteomyelitis)
  6. Epidural or cerebral abscess
* Other inclusion criteria have been applied

Exclusion Criteria:

* Treatment with potentially effective (anti-staphylococcal) systemic antibacterial treatment for more than 48 h within the 7 days prior to randomization; Exception: Documented failure of bloodstream clearance
* Bloodstream or non-bloodstream concomitant infections with Gram-negative bacteria that are known to be non-susceptible to either ceftobiprole or aztreonam
* Left-sided infective endocarditis
* Prosthetic cardiac valves or valve support rings, cardiac pacemakers, automatic implantable cardioverter-defibrillator, or left-ventricular assist devices
* Community- or hospital-acquired pneumonia
* Opportunistic infections within 30 days prior to randomization, where the underlying cause of these infections is still active
* Requirement for continuous renal-replacement therapy
* Women who are pregnant or nursing
* Other exclusion criteria have been applied
Safety and Efficacy of Laparoscopic Truncal Vagotomy for the Treatment of Obesity

This two site study will evaluate the safety and effectiveness of laparoscopic truncal vagotomy for the treatment of obesity with baseline study and 18 month post op follow up.

30 morbidly obese patients evenly enrolled at The University of California San Francisco and at the University of Rochester will be selected for study on a voluntary basis. They will have a BMI of \>35 with at least one obesity related comorbidity or a BMI between 40 and 45. Subjects will undergo specific tests of vagal function and baseline metabolic evaluation at baseline.

Thereafter they will undergo a laparoscopic truncal vagotomy. Over 18 months, post operative tests of adequate vagotomy, weight loss, change in body composition and metabolism will be studied.

Eligibility Criteria:
Inclusion Criteria:

* male or female age 25-55
* BMI 35-40 with comorbidity and BMI 40-45 with or without comorbidity
* Stable weight for the last 3 months
* willing to use contraceptives
* motivated to lose weight
* a personal history of at least one professionally supervised 6 month attempt or more than 2 serious attempts to loose weight
* fully ambulatory

Exclusion Criteria:

* sign of prior major abdominal surgery
* history of or signs and /or symptoms of gastro-duodenal ulcer disease
* abnormal vagus nerve testing
* current use of a list of medication
Effectiveness of Endocuff Vision in Improving ADR

The goal of distal attachment devices is to enhance an endoscopist's adenoma detection rate (ADR). A device called EndoCuff Vision (ECV) has been introduced that employs a single row of flexible arms to evert colonic folds, thus optimizing mucosal visualization and enhancing ADR. ECV has been shown to be efficacious in improving ADR within the context of randomized trials. However, no 'real-world' studies have been published assessing the effectiveness of ECV in non-trial settings. The primary objective of this study is to assess the effect of ECV use on ADR in a routine screening-related population.


Eligibility Criteria:
Inclusion Criteria:

adult patients undergoing colonoscopy.

Exclusion Criteria:

* single balloon- or double balloon-assisted colonoscopy;
* planned advanced polypectomy or endoscopic mucosal resection (EMR);
* planned endoscopic post-polypectomy or post-EMR surveillance;
* known active diverticulitis;
* known colonic stricture.
Integrative Analysis of Pulmonary Sarcomatoid Carcinoma (PSC)

Integrative Analysis of pulmonary sarcomatoid carcinoma (PSC)

The investigators will analyzed proteomes of paired normal lung tissues and pulmonary sarcomatoid carcinoma with or without metastasis, sequenced transcriptomes, perform whole exome sequencing, and single nucleotide polymorphism (SNP) array profiling for triplets, each comprising normal lung tissue, primary pulmonary sarcomatoid carcinoma, and its synchronous matched metastasis, as well as analyzed genomics of lung cancer characterized previously by The Cancer Genome Atlas (TCGA) to conduct integrated proteogenomic analyses.

Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 70 years with histologically proven LCLC
* No severe major organ dysfunction
* World Health Organization (WHO) performance status of 0 or 1
* No prior cancer chemotherapy

Exclusion Criteria:

* Age ≥ 70
* Severe major organ dysfunction
* WHO performance status of \>1
* Prior cancer chemotherapy