cyrilzakka/clinical-trials huggingface dataset:
Validation of a Preclinical Model Based on Patient-derived Organoids for the Study of the Gut-joint Axis in Spondyloarthritis

This project aims to develop and validate a model of human organoids derived from patients with Spondyloarthritis, focusing on synovial and intestinal tissues as targets of the gut-joint axis. The tissue marker profile of patient-derived organoids studied by gene expression, immunohistochemistry, and cytokine production profile will be compared with that of controls in order to test for the presence of specific biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* More than 18 years of age;
* Ability to understand and sign an informed consent form;
* Clinical indication for intestinal and/or synovial biopsy;
* Only for SpA patients group: meeting ASAS classification criteria.

Exclusion Criteria:

* Actively treated cancer;
* Severe comorbidities that, in the investigator\&#39;s opinion, may affect the quality of samples for planned experimental applications;
* Only for patients undergoing ileal-colic biopsy: history of colorectal cancer disease, celiac disease;
* Only for patients undergoing a synovial biopsy: septic arthritis.
Gluten Free Diet in IBS

Patients with irritable bowel syndrome (IBS) often benefit from dietary changes. The effect of a gluten-free diet (GFD) on clinical symptom improvement and psychological well-being will be checked in patients with IBS. In addition, the stimulatory potential of gluten on peripheral blood monocytes will be determined. Responders will be provoked with gluten containing bars or placebo bars to confirm the diagnosis of non-celiac glutensenstitivity.

Patients with irritable bowel syndrome (IBS) often benefit from dietary changes. Since it has been shown that a gluten free diet (GFD) often alleviates the clinical symptoms, an overlap between patients with IBS and non-celiac glutensensitivity is assumed. The study includes 25 healthy individuals and 150 patients with IBS taking a six week GFD. Participants fill in questionnaires to determine clinical symptoms and psychological well being at the beginning and end of the dietary intervention. Patients with symptom relief under diet are further provoked in a double-blind placebo-controlled study with gluten or placebo containing bars for three weeks, separated by two weeks of washout to diagnosis of NCGS.

In addition, peripheral mononuclear cells are isolated at the beginning and end of the diet and the stimulating potential of wheat gluten is analyzed.

Eligibility Criteria:
Inclusion Criteria:

* healthy controls without gastrointestinal Symptoms
* patients with irritable bowel Syndrome (Rome IV criteria)

Exclusion Criteria:

* inflammatory bowel disease (Crohn's disease, Ulcerative colitis)
* celiac disease
* wheat allergy
* pregnancy
Whole Transcriptome Profiling and Metabolic Phenotyping in Children With ROHHAD Syndrome

Rapid onset Obesity, Hypoventilation, Hypothalamic dysfunction and Autonomic Dysregulation (ROHHAD) is a syndrome named in 2007. The hallmark of the syndrome is the rapid onset obesity and dysregulation of central ventilation. There is little information about the metabolic changes that lead to the rapid onset obesity in these children. The investigators would like to study the metabolic phenotype of these children to understand the disturbances in energy balance that lead to the rapid onset obesity.

Late-onset hypoventilation syndrome with hypothalamic dysfunction was first described in 1965 and renamed to ROHHAD syndrome in 2007 by Ize-Ludlow et al.

The hallmark of ROHHAD syndrome is rapid-onset obesity starting at approximately 1.5 years of age with weight gain of 12-20 kg/year, central hypoventilation distinct from the obstructive hypoventilation caused by obesity, hyperphagia, a spectrum of pituitary hormonal dysfunction, and autonomic disturbances including temperature, blood pressure, and nociception abnormalities. Some children have been noted with developmental and behavioral abnormalities. Tumors of neural crest origin have been identified in 25-33% of the patients. The etiology of ROHHAD syndrome and the cause of rapid onset obesity is unknown.

The aims of this study are to understand the whole transcriptome profiling of patient specific induced pluripotent cell (iPSC) derived hypothalamic neurons to understand the transcriptional level changes that give rise to the manifestations seen in ROHHAD syndrome.

Aim 1. Generate patient specific iPSC-derived hypothalamic neurons from children with ROHHAD syndrome and their unaffected first degree relatives.

Aim 2: Compare the whole transcriptome profiling of the patient derived cells compared to those of unaffected relatives and reference datasets to understand the differences in transcriptome that gives rise to ROHHAD syndrome.

Aim 3: Selected patients may be invited to participate for detailed metabolic phenotyping to understand the mechanisms of excessive weight gain.

Eligibility Criteria:
Inclusion Criteria:

* Children with ROHHAD syndrome

Exclusion Criteria:

* Children with known genetic causes of obesity
Detect Fluid Early From Intra-thoracic Impedance Monitoring

To demonstrate the safety and effectiveness of the Impedance Monitoring Feature in St Jude Medical cardiac devices.


Eligibility Criteria:
Inclusion Criteria:

* Must have a St. Jude Medical (SJM) ICD or CRT-D for at least 31 days
* Must have had an episode of acute decompensated heart failure (ADHF) within the past 6 months

Exclusion Criteria:

* History of kidney disease requiring hemodialysis
* Refractory end stage heart failure
Clinical Study of GPA33-specific PET/CT for the Diagnosis of Colorectal Cancer

In this study, we will first investigate the imaging safety and feasibility of \[68Ga\]Ga-NOTA-WWH347 and \[18F\]F-H3RESCA-WWH347 PET/CT in patients with primary and/or metastatic colorectal cancers. The second goal of the study is to preliminarily investigate the diagnostic efficacy (e.g., sensitivity and specificity) of \[68Ga\]Ga-NOTA-WWH347 and \[18F\]F-H3RESCA-WWH347 PET/CT in patients with primary and/or metastatic colorectal cancers. This study will provide a new method for the noninvasive target-specific diagnosis of colorectal cancer, and provide an intuitive and clear imaging basis for clinical diagnosis, differential diagnosis and treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Be between 18 and 65 years of age and of either sex.
2. Patients with colorectal cancer confirmed by puncture or surgical pathology.
3. Written informed consent signed by the subject or legal guardian or caregiver.
4. Willingness and ability to cooperate with all programs of this study.

Exclusion Criteria:

1. Severe hepatic or renal insufficiency;
2. Targeted therapy before radiotherapy or PET/CT scan. Renal function: serum creatinine less than or equal to the upper limit of the normal range;
3. Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range.
4. History of serious surgery in the last month.
5. Those who have participated in other clinical trials during the same period.
Viral Activation Transfusion Study (VATS)

The purpose of the trial was to determine if transfusion of allogeneic blood to HIV-1 infected persons led to immune activation and consequent induction of HIV-1 or /or Cytomegalovirus (CMV) replication, and whether this adversely affected clinical prognosis.

BACKGROUND:

The initiative was approved by the NHLBI AIDS Ad Hoc Working Group and given concept clearance by the September 1993 National Heart, Lung, and Blood Advisory Council. The initiative was released in January 1994.

DESIGN NARRATIVE:

Patient enrollment started in August 1995. Patients scheduled for transfusion were entered into the study at the time of their first transfusion and randomized to receive leukopoor red cells filtered within 24 hours of collection or unmanipulated blood components. Patients received blood as per their treatment arm as needed for one or two years. Patients were stratified to those with CD4 counts below 50 /MM3 (most patients) and those with CD4 counts above that level. Primary endpoints were overall survival and a change in HIV viremia after the 1st transfusion. The secondary endpoint was the occurrence of a new AIDS-defining complication. A substudy looked at donor lymphocytes in the immunosuppressed recipients to help determine why AIDS patients don't seem to get post-transfusion graft-vs-host disease. The patient recruitment time was extended for one year because of low accrual. With new drugs, especially protease inhibitors, the proportion of patients needing transfusion has decreased. The patients are less severely ill and their disease produces less anemia. Furthermore, the new drugs don't have anemia as a side effect. The trial ended in January, 2000.

The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).

Eligibility Criteria:
HIV-infected patients with CD4 counts below 250 who clinically needed red blood cell transfusions.
Study to Treat Uveitis Associated Macular Edema

The purpose of this study is to determine whether denufosol tetrasodium (INS37217) Intravitreal Injection is well tolerated and has the potential to treat uveitis associated macular edema.

Denufosol tetrasodium (INS37217) Intravitreal Injection may provide clinical benefit in treatment of uveitis associated macular edema (UME) by reducing retinal thickness as measured by OCT and possibly enabling recovery of vision loss associated with UME. Denufosol tetrasodium may also reverse the fluid accumulation of UME.

Eligibility Criteria:
Inclusion Criteria:

* Have anterior uveitis, intermediate uveitis, posterior uveitis or panuveitis in at least one eye
* Have persistent macular edema and uveitis whose conditions are stable
* Have no change in medication regimen for at least 3 months prior to randomization if currently taking medications such as immunosuppressive or anti-inflammatory agents; steroidal or non-steroidal agents (drops, oral or injected)
* Have an OCT scan with a qualifying retinal thickness in the study eye
* Have evidence of macular edema on OCT scan
* Have at lease one eligible eye to be treated in the study based on visual acuity.

Exclusion Criteria:

* Have proliferative vitreoretinopathy greater than grade B
* Have subretinal or vitreous hemorrhage, corneal opacity, or other conditions, which limit the view of the retina or obscure FA
* Have uncontrollable elevated IOP, advanced, previous filtration surgery, or any current evidence of endophthalmitis in the study eye
* Have ocular disorders in the study eye that may confound interpretation of study results
* Have had cataract surgery in the study eye within 3 months, YAG laser capsulotomy within the past 1 month, or any other intraocular surgery within the past 90 days
* Have pre-operative spherical equivalent refractive error of more than -10 diopters of myopia in the study eye
* Have had any intravitreal or periocular injection or corticosteroids in the study eye during the 3 months prior to screening
* Have any ocular implant device for the delivery of therapeutic agents to the eye
* Be taking any excluded medications that could obscure or confound study results
Shanghai Non-pharmacological Intervention of Mild Cognitive Impairment

This study evaluates the effects of "computerized cognitive training" and "cognitive training plus exercise training" on different cognitive domains in mild cognitive impairment (MCI) patients. Patients will be randomized into the computerized training group, cognitive training plus exercise training group and the control group.

Mild cognitive impairment (MCI) is an early stage of Alzheimer Disease (AD). Increasing evidence has indicated that cognitive trainings improve cognition functions of MCI patients in multiple cognitive domains, making it a promising therapy for MCI. However, the effect of long-time training has not been widely explored. It is also necessary to evaluate the extent of its function in reducing the conversion rate from MCI to AD.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 50-85;
* MCI diagnosed according to the National Institute on Aging-Alzheimer's Association (NIA-AA) workgroups\[1\];
* 24≤Mini-Mental State Examination (MMSE) ≤28；
* The Hamilton Depression Scale/17-item (HAMD) score ≤10;
* Not on medication for dementia;
* MRI T2 weighted image (T2WI) scan: aged ≤70 , Fazeca scale for White Matter lesions rating level≤1; \>70 years, white matter damage rating scale ≤2. The number of lacunar infarcts larger than 2 cm in diameter ≤2. No infarcts in hypothalamus, entorhinal cortex, para-hypothalamus, cortical and subcortical cavity infarction near gray matter nuclei. The medial temporal lobe atrophy (MTA) score: Grade II or above.
* Accompanied by reliable caregivers (at least intensive contact of 4 days every week and 2 hours every day) who are expected to participate in the follow-up visits and provide useful information for scores of scales like ADCS-ADL;
* Education level: primary school (grade 6) or above.
* Expected good compliance with the therapy and follow-up. Each patient gives a written informed consent, and the study has been approved by Ruijin Hospital's ethical committees.

Exclusion Criteria:

* Cognitive decline caused by other diseases (cerebrovascular disease, central nervous system infections, Parkinson's disease, metabolic encephalopathy, intracranial space-occupying lesions, deficiency of folic acid/vitamin B12 and hypothyroidism);
* Medical history of other neurological disorders (including stroke, Neuromyelitis optica, Parkinson's disease, epilepsy, etc.);
* Psychiatric disorders defined by (Diagnostic and Statistical Manual of Mental Disorders) DSM-IV criteria;
* Unstable or severe disease of heart, lung, liver, kidney or hematopoietic system;
* History of alcohol or drug abuse;
* Participation in other clinical trial less than 30 days before the screening of this study;
* Inability to complete the study.
Global Trial in APG2575 for Patients With CLL/SLL

This is a global multicenter, open label, randomized, registrational phase III study to investigate the efficacy and safety of lisaftoclax in combination with BTK inhibitors in CLL/SLL patients who previously treated with BTK inhibitors

Approximately 440 patients will be enrolled, the patients who meet the eligibility criteria will be randomized in a 1:1 ratio to investigational arm (lisaftoclax in combination with a BTK inhibitor) or the control arm (BTK inhibitor alone). These patients with CLL/SLL have been on BTKi monotherapy and meet all other protocol required eligibility criteria.

Eligibility Criteria:
Inclusion Criteria:

1. - Age ≥ 18 years.
2. . Patients that have documented CLL/SLL who meet iwCLL 2018 criteria for CLL treatment guidelines are eligible for treatment and must be receiving BTKi monotherapy for at least 12 months
3. ECOG Performance Status grade 0-2
4. Adequate bone marrow function independent of growth factor or transfusion support within 2 weeks of screening initiation as follows:

   * Absolute neutrophil count ≥ 1.0 × 109/L
   * Platelet counts ≥ 75 × 109/L; in cases of thrombocytopenia
   * Total hemoglobin ≥ 9 g/dL,
5. Adequate renal function

   * Creatinine clearance must be \> 50 ml/min directly measured with 24hr urine collection or calculated according to the modified formula of Cockcroft and Gault (for men: GFR ≈ ((140 - age) x actual body weight)/(72 x creatinine), for women x 0.85) or an equally accurate method.
   * For patients with creatinine values within the normal range, the calculation of clearance is not necessary. Dehydrated patients with an estimated creatinine clearance less than 50 ml/min may be eligible if a repeat estimate after adequate hydration is \> 50 ml/min.
6. Adequate liver function as indicated by:

   * Total bilirubin ≤ 1.5 x ULN, except patients with known Gilbert's Syndrome
   * Aspartate aminotransferase (AST) ≤ 2.5 x the institutional ULN value
   * Alanine aminotransferase (ALT) ≤ 2.5 x the institutional ULN value,
   * International normalized Ratio (INR), Prothrombin Time (PT) or Activated Partial Thromboplastin time (APTT) ≤ 1.5×ULN.
7. Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements
Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacodynamics of Entospletinib in Adults With Relapsed or Refractory Hematologic Malignancies

The primary objective of the study is to evaluate efficacy of entospletinib in participants with relapsed or refractory hematologic malignancies. Participants with the following relapsed or refractory hematologic malignancies will be enrolled into the study: relapsed or refractory chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), or non-FL indolent non-Hodgkin lymphomas (iNHL; including lymphoplasmacytoid lymphoma/ Waldenström macroglobulinemia \[LPL/WM\], small lymphocytic lymphoma \[SLL\], or marginal zone lymphoma \[MZL\]).


Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosis of B-cell iNHL, DLBCL, MCL, or CLL as documented by medical records and with histology based on criteria established by the World Health Organization
* For institutions that have Phase 3 or Phase 4 protocols studying idelalisib (Zydelig®) ; individuals with malignancies being studied in these protocols must have failed screening in the respective idelalisib protocol
* Prior treatment for lymphoid malignancy requiring treatment for progressive disease
* Presence of radiographically measurable lymphadenopathy or extranodal lymphoid malignancy
* All acute toxic effects of any prior antitumor therapy resolved to Grade ≤ 1 before the start of study drug
* Karnofsky performance status of ≥ 60
* Life expectancy of at least 3 months

Key Exclusion Criteria:

* Known histological transformation from iNHL or CLL to an aggressive form of non-Hodgkin lymphoma (ie, Richter transformation) except if the CLL participant is enrolling in the BCR previously treated cohort
* Known active central nervous system or leptomeningeal lymphoma
* Presence of known intermediate- or high-grade myelodysplastic syndrome
* Evidence of ongoing systemic bacterial, fungal, or viral infection at the time of start of study drug
* Ongoing liver injury
* Ongoing or recent hepatic encephalopathy
* Ongoing drug-induced pneumonitis
* Ongoing inflammatory bowel disease
* Ongoing alcohol or drug addiction
* Pregnancy or breastfeeding
* History of prior allogeneic bone marrow progenitor cell or solid organ transplantation
* Ongoing immunosuppressive therapy
* Concurrent participation in an investigational drug trial with therapeutic intent

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
An Open-Label Study of JZP-458 (RC-P) in Patients With Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)

This is an open-label, multicenter, dose confirmation, and PK study of JZP-458 in patients (of any age) with ALL/LBL who are hypersensitive to E. coli-derived asparaginases (allergic reaction or silent inactivation). This study is designed to assess the tolerability and efficacy of JZP-458 (only in patients who develop hypersensitivity to an E. coli-derived asparaginase), as measured by asparaginase activity.


Eligibility Criteria:
Inclusion Criteria:

1. Pediatric and adult patients with a diagnosis of ALL or LBL.
2. Have had an allergic reaction to a long-acting E. coli-derived asparaginase OR have silent inactivation.
3. Have 1 or more courses of E. coli-derived asparaginase remaining in his/her treatment plan.
4. Patients must have, in the opinion of the Investigator, fully recovered from their prior allergic reaction to E. coli-derived asparaginase.

Exclusion Criteria:

1. Have previously received asparaginase Erwinia chrysanthemi or JZP-458.
2. Have relapsed ALL or LBL.
3. Are concurrently receiving another investigational agent and/or treated with an investigational device at the same time as JZP-458 (within 48 hours) during Course 1 of JZP-458.
4. Have a history of ≥ Grade 3 pancreatitis.
5. Prior history of asparaginase-associated ≥ Grade 3 hemorrhagic event or asparaginase-associated thrombus requiring anticoagulation therapy, excluding catheter-related thrombotic events.
China Registry of Non-disabling Ischemic Cerebrovascular Events

The burden of non-disabling ischemic cerebrovascular events (NICE) is significantly increased. In order to achieve accurate risk stratification and effective treatments, developing new diagnostic, therapeutic, and prognostic strategies is indispensable. Chinese registry of NICE is a national multi-center prospective study aimed to explore the epidemiology, new biomarkers, risk factors and prognostic models.

The pathophysiology of transient ischemic attack (TIA) and minor stroke is a continuous progression. TIA and minor stroke exhibit the common substantial risk factors for early stroke recurrence and epidemiological characteristic. Since TIA and minor stroke may leave impermanent or mild neurological deficit, they are termed as non-disabling ischemic cerebrovascular disease (NICE).

The results of the China Chronic Disease and Risk Factor Surveillance (CCDRFS) 2010 showed that the age-standardized prevalence of TIA is 2.27%. Estimated 23.9 million people may have experienced a TIA in China. The TIA knowing-rate is approximately 3.08% in Chinese adults, only 5.02% received treatment and 4.07% received guideline recommended therapy. The Second China National Stroke Registry (CNSR-II) indicated that minor stroke accounted for 42.23% of all the hospitalized patients of ischemic stroke, which is much higher than that showed in CNSR-I (2007-2008). Thus, it is imperative to develop new strategies to improve the diagnosis, risk prediction and appropriate management of NICE.

NICE is an attractive researching area globally. According to the large quantities of NICE patients in China and the low standardized therapeutic rate, the awareness of NICE is largely insufficient. The purpose of the present study is to establish a multi-center national prospective database of NICE, including clinical information and biological samples library and, to further explore the epidemiology, new biomarkers, risk factors, and prognostic models.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old
2. elapsed time from last episode to registry \<48 hours

Exclusion Criteria:

1. patients who refused to participate in the research, and patients who failed to complete the follow-up protocol.
2. patients with malignant tumors, or patients with severe liver or kidney disease, whose life expectancy is less than 1 year.
3. patients who received endovascular or thrombolytic therapy.
Effect Of Myofascial Release Technique With Ultrasound Therapy in Adults With Nonspecific Low Back Pain.

Low back pain is common problem the purpose of this research will be to determine the comparison of ultrasound therapy and myofascial release technique for treatment of low back pain in adults.

Low back pain is common problem the purpose of this research will be to determine the comparison of ultrasound therapy and myofascial release technique for treatment of low back pain in adults. To increase lumbar spine range of motion chest wall mobility and flexibility, reduction in level of lumbar disability

Eligibility Criteria:
Inclusion Criteria:

* Both male and female
* between age of 18 and 60 reported with chronic low back pain (lasting more than 3 months)

Exclusion Criteria:

* unresponsive psychologically disturbed patient
* people under 18
* Following coexisting conditions cancer, diabetes, pregnancy, cardiovascular system, gynecological disease.
* Neurological conditions, spine injury contraindicated to MFR treatment (infectious disease, viral and bacterial infections, active malignant disease, aneurysm
* Arthrodesis