cyrilzakka/clinical-trials huggingface dataset:
CD20-CD19 Compound CAR (cCAR) T Cells for Patients With Relapsed /Refractory B Cell Malignancies

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of CD20-CD19 cCAR in patients with relapsed and/or refractory B cell malignancies.

Clinical trials with CD19-directed CARs have achieved unprecedented remission rates as high as 90%. However, recent follow-up studies have shown a substantial portion of treated patients relapsed due to antigen escape. CD20-CD19 cCAR is a compound Chimeric Antigen Receptor (cCAR) immunotherapy with two distinct functional CAR molecules expressed on a T-cell, directed against the surface proteins CD20 and CD19. CD20-CD19 cCAR intends to target the mechanisms of single-CAR relapse, specifically antigen escape.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis based on the World Health Organization (WHO) 2008
2. Histologically demonstrate CD19 or CD20 expressing B cell lymphoma or B ALL
3. Patients have exhausted standard therapeutic options
4. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks
5. Female must be not pregnant during the study

Exclusion Criteria:

1. Patients declining to consent for treatment
2. Prior solid organ transplantation
3. Potentially curative therapy including chemotherapy or hematopoietic cell transplant
4. Prior treatment with CD20xCD3 or CD19x3 bispecific agents
Safety and Pharmacokinetics of Abicipar Pegol Intravitreal Injections in Patients With Neovascular AMD

This study will evaluate the safety and characterize the systemic pharmacokinetics (PK) of free and vascular endothelial growth factor (VEGF)-bound abicipar following single and multiple intravitreal injections of abicipar pegol in treatment-naïve patients with neovascular age-related macular degeneration (AMD).


Eligibility Criteria:
Inclusion Criteria:

-Presence of active subfoveal and/or juxtafoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).

Exclusion Criteria:

* History of or active periocular, ocular, or intraocular infection.
* Previous use of verteporfin photodynamic therapy (PDT) or any ocular anti-angiogenic therapy (eg, aflibercept, bevacizumab, ranibizumab, pegaptanib), approved or investigational, for the treatment of neovascular AMD or previous therapeutic radiation in the region.
* Prior use of ocular anti-VEGF agents for neovascular eye diseases other than AMD.
* Macular hemorrhage that involves the center of fovea in the study eye.
* Any prior or current systemic or ocular treatment (including surgery) for neovascular AMD in the study eye.
* Treatment with ocular corticosteroid injections or implants within 6 months in the study eye.
* History or evidence of eye surgery: Pars plana vitrectomy, Submacular surgery or other surgical interventions for AMD, Incisional glaucoma surgery or Cataract or refractive surgery within the last 3 months.
* AMD in the non-study eye that requires anti-VEGF treatment.
Rhythmic Sensory Stimulation on Fibromyalgia

The aim of this project is to further examine the effectiveness of Rhythmic Sensory Stimulation (RSS) with low-frequency sounds and somatosensory stimulation as a complementary therapy for fibromyalgia, and to investigate potential mechanisms underlying the effects of RSS on chronic pain.


Eligibility Criteria:
Inclusion Criteria:

* patients with clinical diagnosis of fibromyalgia
* able to read and write English adequately
* have satisfactory hearing bilaterally (self-reported)
* have the ability to operate the supplied device

Exclusion Criteria:

* acute and active inflammatory conditions (e.g., rheumatoid arthritis, osteoarthritis, autoimmune disease)
* medical or psychiatric illness
* history of psychosis, epilepsy, seizures
* pregnancy or breast feeding
* hemorrhaging or active bleeding
* thrombosis, angina pectoris
* heart disease, such as hypotension, arrhythmia, pacemaker
* substance abuse (harmful or hazardous use of psychoactive subtances, including alcohol and illicit drugs) in the last year
* suffering from a recently prolapsed vertebral disc
* recovering from a recent accident with back or neck injury.
Improved Ability to Cope With Everyday Life Through a Person-centered Training Program in Elderly Patients With Rheumatoid Arthritis - PEP-walk Study

The purpose of this study is to examine whether person-centered high-intense aerobic / strength training during five months reduces inflammation and disease activity, improve immune cell function, and increases muscle strength, fitness and ability of the individual independence in elderly patients with rheumatoid arthritis.


Eligibility Criteria:
Inclusion

* Patients 65 years or older with RA diagnosed according to the ACR / EULAR 1987/2010 criteria,
* disease duration 2 years or more,
* disease activity as measured by DAS28 \<5.1

Exclusion

* Comorbidities, such as unstable coronary artery disease, uncontrolled cardiac arrhythmia, or uncontrolled high blood pressure, which prevents moderate to intense exercise.
* Joint surgery completed within 6 months prior to study entry.
* Ongoing training at moderate to high level 2 or more times per week
The Effect of Sit-Stand Workstations on Physical Activity in Sedentary Office Workers

The purpose of this study was to determine whether the installation of sit-stand work stations could lead to decreased sedentary time and increased physical activity during the workday among sedentary office workers.


Eligibility Criteria:
Inclusion Criteria:

* Mostly sedentary (sitting ≥ 4 hour) during the workday.
* Age ≥ 18
* Anticipated using a single computer workstation for 20 hours or more per week

Exclusion Criteria:

* Unable to stand for at least two hours per workday (two hours over the whole workday, not consecutively)
* Reported severe musculoskeletal symptoms, specifically lower extremity or lower back pain.
* Diagnosed with or under treatment for diabetes, heart disease, cancer, orthostatic hypertension, varicose vein, autoimmune disease, or other chronic diseases.
* Pregnant women
Trial of Plasma Exchange for Severe Crescentic IgA Nephropathy

Crescentic IgA nephropathy (CreIgAN) has a poor prognosis despite aggressive immunosuppressive therapy. The efficacy of plasma exchange (PE) in CreIgAN is not well defined. This study will evaluate the efficacy and safety of plasma exchange as adjunctive therapy for severe crescentic IgA nephropathy compared to pulse methylprednisolone on a background of oral prednisolone and cyclophosphamide in prevent kidney failure.

IgA nephropathy (IgAN) is one of the most common glomerulonephritides and is characterized by a highly variable clinical course and diverse histopathological lesions. Although most affected individuals develop chronic, slowly progressive renal injury, a subgroup of patients (\<5% of all IgAN patients) with diffuse crescent formation, which is termed as crescentic IgA nephropathy (CreIgAN) and often leads to rapidly progressive kidney failure. The recent Kidney Disease: Improving Global Outcomes (KDIGO) guidelines suggest high-dose steroids and cyclophosphamide therapy for CreIgAN. However, this suggestion is mainly based on several small observational studies, and the 1- and 5-year renal survival rates of patients treated with this regimen were as low as 65% and 28%, respectively, in one large cohort of CreIgAN patients. The efficacy of plasma exchange (PE) in severe CreIgAN is not well evaluated, although several anecdotal reports have indicated benefit of PE in combination with immunosuppressive therapies in IgAN patients. Retrospective cohort study in our unite also supported the benefit of PE as additional therapy for CreIgAN patients. However, randomized controlled trial is needed to evaluate the efficacy and safety of plasma exchange as adjunctive therapy for crescentic IgA nephropathy compared to pulse methylprednisolone on a background of oral prednisolone and cyclophosphamide in prevent kidney failure.

Eligibility Criteria:
Inclusion Criteria:

1. Biopsy-proven within 3ws
2. Primary IgAN or Henoch-Schönlein Purpura nephritis of crescent \>50%(\>8 glomeruli)
3. Serum creatinine ≥ 200 μmol/l， rapidly deterioration of renal function

Exclusion Criteria:

1. \<14 or \>65 years old
2. With high Scr requiring dialysis for≥ 3w
3. Scr\>200μmol/L ≥1 yr before entry
4. Main of old crescent ; Fibrous crescent\>50%
5. Anti-glomerular basement membrane (GBM) or antineutrophil cytoplasmic antibody (ANCA) antibody positive
6. Women in gestational and lactational period
7. With diabetes or uncontrollable malignant hypertension or Thrombotic Microangiopathy
8. With Malignancy
9. Chronic active infection including HBV hepatitis C virus (HCV) HIV or active tuberculosis
10. Other autoimmune disease
11. A second clearly defined cause of renal failure
12. Contraindication of plasma exchange treatment or steroid pulse
13. Patients who are unlikely to comply with the study protocol in the view of the treating physician.
Bioequivalence Study of Telmisartan Between Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg (T80/A5/H12.5 mg) Fixed-dose Combination (FDC) Tablet and T80/H12.5 mg Tab and A5 mg (Encap A2.5 mg Tab x2) Concomitant Use

To investigate the steady state pharmacokinetics of different formulation of Telmisartan, Amlodipine, and Hydrochlorothiazide (HCTZ).


Eligibility Criteria:
Inclusion criteria:

* Healthy male subjects age \>=20 and \<=35 years; body weight: \>=50 kg and \<=80 kg; body mass index: \>=18.0 and \<=25.0 kg/m2
* Without any clinically significant findings and complications on the basis of a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR), body temperature)
* Signed and dated written informed consent prior to admission to the trial in accordance with the Good Clinical Practice (GCP) and the local legislation

Exclusion criteria:

- Any finding of the medical examination (including BP, PR and ECGs) deviating from normal and of clinical relevance
NMDA Modulation in Major Depressive Disorder in Late- Life

Major depressive disorder (MDD) is a complex and multi-factorial disorder. Most of the current antidepressants are based upon the monoamine hypothesis which cannot fully explain the etiology of depression. Many elderly patients have significant side effects after treatment with antidepressants which hamper the motivation for treatment and medication adherence. NMDA hypofunction has been implicated in the pathophysiology of depression. MDD in the elderly is often associated with cognitive deficits which are not necessarily recovered by current antidepressants. The NMDA receptor regulates synaptic plasticity, memory, and cognition. In our previous studies, cognitive improvement has been observed with treatment of NMDA enhancers. Therefore, this study will examine the efficacy and safety as well as cognitive function improvement of NMDAE in the treatment of MDD in the elderly by comparing with sertraline (a selective serotonin reuptake inhibitor \[SSRI\]) and placebo.

The investigator will enroll elderly patients with MDD for an 8-week treatment. All patients will be randomly assigned into three groups: NMDAE, sertraline, or placebo. The investigator will biweekly measure clinical performances. Cognitive functions will be assessed at baseline and at endpoint of treatment by a battery of tests. The investigator hypothesize that NMDAE can safely yield better efficacy than placebo and sertraline for elderly patients with MDD.


Eligibility Criteria:
Inclusion Criteria:

* Have a DSM-IV (American Psychiatric Association 1994) diagnosis of MDD
* 17-item Hamilton Rating Scale for Depression total score ≥ 18
* Free of psychotropic drugs for at least 2 weeks
* Have a Mini-Mental State Examination (Folstein, Folstein et al. 1975) score ≥ 20

Exclusion Criteria:

* Current substance abuse or history of substance dependence in the past 6 months
* Use of depot antipsychotics in the past 6 months
* History of epilepsy, head trauma, stroke or other serious medical or neurological illness
* Bipolar depression, schizophrenia or other psychotic disorder
* Moderate-severe suicidal risks
* Severe cognitive impairment
* Initiating or stopping formal psychotherapy within six weeks prior to enrollment
* A history of poor response to SSRIs or other antidepressants
* A history of previously received electroconvulsive therapy
* A history of severe adverse reaction to SSRIs or other antidepressants
* Inability to follow protocol
Is There a Link Between Anatomical Markers of Surgical Difficulty and Incapacity to Reverse Stoma After Low Rectal Cancer Surgery?

Anterior resection with total mesorectal excision (TME) is the standard procedure for mid and low rectal cancers . A colo-rectal anastomosis under peritoneal reflection is, most of the time, protected by a temporary loop stoma to decrease the risk and severity of anastomotic morbidity. This stoma, which is intended to be temporary, appears to be permanent in 6 to 32% of cases in the literature. The main risk factor being anastomotic leakage. Two major risk factors for anastomotic leakage after colorectal surgery are " male sex " and " Body mass index ", which are responsible of a higher anatomical difficulty (Narrow pelvis and bulky mesorectal fat) Therefore, the objective of this study is to look for a statistical link between permanent stoma and intraoperative difficulty represented by pelvic anatomical constraints.

Anterior resection with total mesorectal excision (TME) is the standard procedure for mid and low rectal cancers . A colo-rectal anastomosis under peritoneal reflection is, most of the time, protected by a temporary loop stoma to decrease the risk and severity of anastomotic morbidity. This stoma, which is intended to be temporary, appears to be permanent in 6 to 32% of cases in the literature. The main risk factor being anastomotic leakage. Two major risk factors for anastomotic leakage after colorectal surgery are " male sex " and " Body mass index ", which are responsible of a higher anatomical difficulty (Narrow pelvis and bulky mesorectal fat) Studies focused on surgical difficulties usually evaluated criteria such as, total surgery duration, blood loss or surgeon's subjective evaluation. The investigators of this retrospective study hypothesize that when a stoma,primarily intended to be temporary, is not reversed after a long (2 years) post operative delay, it all comes to surgical difficulties and that these surgical difficulties are essentially represented by anatomical constraints. Therefore, the objective of this study is to look for a statistical link between permanent stoma and intraoperative difficulty represented by pelvic anatomical constraints.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who underwent a sphincter saving resection for low rectal cancer between January 2019 and December 2017.

Exclusion Criteria:

* Minor patients.
* Patients who have undergone a cancer proctectomy with no restoration of continuity expected.
* Patients who did not have total Mesorectal excision
Effects of Agility and Perturbation Based Training in Addition to Routine Physical Therapy

Osteoarthritis is a degenerative joint disease. Knee OA patients sometimes report episodes of knee instability that limit their ADLs. The episodes of instability are similar to those reported in knee ligament injuries. It is believed that modifications of interventions that are used to promote knee stability in knee ligament injuries can be used in knee OA to enhance knee stability and function. The purpose of this study will be to determine the effects of agility and perturbation-based training in addition to routine physical therapy on pain, function, quality of life and disability in knee osteoarthritis.

A Randomized Clinical Trial will be conducted at Al Syed Touqeer Altaf Surgical Hospital through a convenience sampling technique on 26 patients, which will be allocated using computer-generated randomization into two groups. Group A will be treated with agility and perturbation training techniques in addition to the same routine physical therapy as Group B, and Group B will receive only routine physical therapy. Outcome measures will be conducted through NPRS, WOMAC, SF-36, and KOS-ADLs questionnaires. All the outcome measures will be assessed pre and post-treatment, and the assessor will be blind. Frequency of the treatment will be 3 sessions per week for 4 weeks. Data will be analyzed using SPSS software version 25.

Eligibility Criteria:
Inclusion Criteria:

* Both male and female.
* Subjects with Kellgren and Lawrence grade II and III osteoarthritis.
* OA diagnosed subjects according to American College of Rheumatology ACR criteria;

  * Morning stiffness ≤ 30 minutes.
  * Crepitus with active motion of the knee (while weight bearing).
  * Tenderness to palpation of the bony margins of the joint, bony enlargement, and no palpable warmth.

Exclusion Criteria:

* Ligament or meniscal injury around the knee.
* Suffering from acute synovitis
* Neuromuscular disorders.
* Cognitive impairments.
* Required use of an assistive device for ambulation.
* Reported a history of 2 or more falls within the previous year.
* Undergone total knee arthroplasty.
* Uncontrolled hypertension, history of cardiovascular disease, neurological disorders that affected lower extremity function.
* Severe visual problems.
Pharmacokinetics, Pharmacodynamics and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to investigate pharmacokinetics, pharmacodynamics and safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes for at least 12 months
* Treated with a combination of soluble/protracted human insulin in the ratio of 30/70 in a twice-daily regimen for at least 6 months
* BMI (body mass index) below 39 kg/m\^2
* HbA1c (glycosylated haemoglobin) below 12%
Efficacy and Safety In Poorly Controlled Type 2 Diabetics

The purpose of this study is to gain safety and efficacy information in patients with type 2 diabetes, who have not previously taken any oral antidiabetic medications, and who have an HbA1c value of greater than or equal to 10%, despite diet and exercise.


Eligibility Criteria:
Inclusion criteria:

* Type 2 diabetes
* Drug-naive.
* Laboratory test result for HbA1c of greater than or equal to 10%.
* Written informed consent.

Exclusion criteria:

* Prior use of antidiabetic medications within 3 months of screening.
* Fluid retention (edema).
* Significant liver disease.
* Low red blood cells (anemia).
* Severe or unstable angina (chest pain).
* Congestive heart failure.
* Severe high blood pressure.
* Alcohol or drug abuse.
* Other inclusion or exclusion criteria to be determined by the physician and study sponsor.
A Prospective Study of Cyclophosphamide Treatment for Idiopathic Retroperitoneal Fibrosis

This prospective, interventional, controlled study is aimed to evaluate the efficacy and safety of cyclophosphamide in the treatment of idiopathic retroperitoneal fibrosis, which refers to the chronic nonspecific inflammation of retroperitoneal fascia and adipose tissue that gradually evolves into fibroproliferative disease.

Idiopathic retroperitoneal fibrosis is a chronic disease that requires treatment for a few years. Patients with this disease respond well to glucocorticoid therapy, so you need to take glucocorticoid medication once the diagnosis is established. In addition, most patients need to use immunosuppressants when taking glucocorticoids. At present, the most commonly used immunosuppressants in the world are cyclophosphamide, azathioprine, methotrexate and mycophoranate, etc. The function of the above drugs is to improve the disorder of the immune system function, in order to restore the normal immune state, so that the inflammation and swelling of the affected organs disappear, restore the normal function. It should be emphasized that if the use of hormones and immunosuppressant is not standard or stopped too early, it can lead to disease recurrence. Therefore, after the disease is under control, long-term adherence to medication is needed to maintain a stable state of the disease.

At present, there is no clear treatment guideline for idiopathic retroperitoneal fibrosis in the world, and the addition of immunosuppressant is also out of debate. Therefore, a comprehensive evaluation of its pathogenesis, clinical characteristics and treatment response is needed.

Eligibility Criteria:
Inclusion Criteria:

* age 18-75 diagnosed as IRPF. The diagnosis of idiopathic retroperitoneal fibrosis is based on the following aspects :(1) the swelling of retroperitoneal tissue , which seems neoplastic; (2) A large number of lymphocytes proliferated and infiltrated in the affected tissues and organs, and tissues showed inflammation, fibrosis and sclerosis, in which IgG4-positive cells accounted for less than 50% of plasma cells; (3) Increased inflammatory markers, such as ESR and CRP; (4) Good response to glucocorticoid therapy.

Exclusion Criteria:

* malignancy retroperitoneal fibrosis secondary to other diseases or drugs or abdominal surgeries.
Variability of Impedance Pneumography Tidal Breathing Flow-volume Curves During Sleep in Healthy Children

This is an observational study for the assessment of normal overnight variation in small healthy children using the Ventica Lung Function Testing System. The study is carried out to establish reference ranges for overnight lung function variation using the Ventica test, and to assess the impact of the demographic factors on the Ventica results.


Eligibility Criteria:
Inclusion Criteria:

* 18 months-6 years, both sexes
* Healthy at the time of inclusion
* Laboratory analyses in the reference range or not clinically relevant according to the investigator judgement
* Lung function in the reference range with a negative bronchodilator test result
* Signed informed consent

Exclusion Criteria:

* Preterm birth
* Chronic respiratory disorder of prematurity
* Recurrent bronchitis or recurrent hospitalizations because of a respiratory illness (recurrent pneumonia)
* Primary immunodeficiency
* Chronic rhinosinusitis, synonasal polyposis
* Nasal congestion, adenotonsillar hypertrophy, signs and symptoms of sleep apnea or sleep disordered breathing
* Acute respiratory infection or hospitalization because of an acute illness within 4 weeks prior to inclusion
* Personal or family history or clinical evidence of asthma, atopy or other chronic respiratory disorders (high risk for asthma and allergy)
* Use of asthma rescue or maintenance medication within 4 weeks prior to inclusion
* Implanted or external active medical devices such as pacemakers
Gut Microbiota in Mood Disorders in Lebanese Population

This study aims to evaluate the pathophysiological aspects of the role of inflammation and gut microbiota in mood disorders, in particular in depression, and their therapeutic implications on a cohort of the Lebanese population. Specific objective: The evaluation of probiotic intake (CEREBIOME®, Lallemand Health Solutions Inc., Mirabel, Canada) on the inflammatory state, gut bacterial profile and the depressive state.

Evaluate the effect of oral intake of a probiotic agent on plasma inflammatory markers, gut bacterial profile and depressive state in a subgroup of target patients versus a subgroup treated with placebo, in combination with conventional treatment.


Eligibility Criteria:
Inclusion Criteria:

* Major depressive disorder: current depressive episode according to MINI (DSM-5) with a MADRS score of ≥ 20
* Males and females between ages 18 and 65
* Able to understand and comply with the requirements of the study
* Provision of written informed consent

Exclusion Criteria:

* Patients under anti-inflammatory drugs
* Patients under immuno-suppressants
* Use of any type of laxative
* Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
* Bipolar, schizophrenia, and addiction disorders
* Any antibiotic therapy in the past 4 weeks