cyrilzakka/clinical-trials huggingface dataset:
The Detection of CTCs in Patients With Pancreatic Cancer Undergoing Cryosurgery Combined With DC-CIK Treatment.

Circulating tumor cells (CTCs) have the potential to provide a surrogate for'real-time biopsy' of tumor biological activity. Enumeration and molecular characterization of CTCs in pancreatic cancer could play an important role in diagnosis, predicting the risk for tumor recurrence, and providing novel target therapy biomarkers.In view of these facts, We wanted to demonstrate the value of multiparameter flow cytometry in detecting human tumor cells of pancreatic cancer in normal peripheral blood after cryosurgery with or without dendritic cell(DC)-cytokine-induced killers(CIK) treatment, and we also compared the specificity with reverse transcriptase polymerase chain reaction (RT-PCR) method.

1 day before and 2 days after cryosurgery with or without DC-CIK treatment，approximately 17-mL ethylene diamine tetraacetic acid(EDTA)-blood was drawn by vein puncture from patients with pancreatic cancer and healthy volunteers. The blood of the healthy volunteers will be used to evaluate the sensitivity and specificity and as negative control cells. To avoid contamination with skin cells, 2 mL blood will be discarded before the study samples will be taken.Briefly, the mononucleate cells will be separated from the blood over Ficoll- Paque for 20 min with 1800g at 4℃. The interface cells will be removed and washed, and the red blood cells(RBCs) will be removed using a lysis buffer followed by a repeated wash. The mononuclear cells will be counted and aliquot for RT-PCR and multiparameter flow cytometry on the basis of at least 2-3×106 cells for each methodology. The cell pellet will be resuspended in phosphate-buffered saline for multiparameter flow cytometry and in Trizol reagent for RT-PCR. Aim : Identification of CTCs may lead to better diagnosis and prognosis and could help to choose an adequate therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age:18-75
2. Karnofsky performance status \>60
3. Diagnosis of pancreatic cancer based on histology or the current accepted radiological measures.
4. Classification tumor,nodes,metastasis-classification(TNM) stage: Ⅱ,Ⅲ,Ⅳ
5. Will receive cryosurgery and/or DC-CIK treatment
6. Life expectancy: Greater than 3 months
7. Patients' routine blood test, liver function and kidney function have no obvious abnormalities
8. Ability to understand the study protocol and a willingness to sign a written informed consent document

Exclusion Criteria:

1. Patients with other primary tumor except pancreatic cancer
2. History of coagulation disorders or anemia
Adrenocorticotropic Hormone in Membranous Nephropathy

The purpose of this study is to evaluate the effect of adrenocorticotropic hormone (ACTH, Acthar) on the loss of proteins in the urine (proteinuria) in patients with membranous nephropathy. Acthar is a hormone that stimulates steroid production from small glands above the kidneys. It has direct protective effects on the kidney and is currently approved by the FDA to treat kidney disorders associated with proteins in the urine, but the mechanisms of action are not entirely understood and will be studied in the present trial.

Patients with membranous nephropathy and nephrotic syndrome will be treated with ACTH for 6 months. Proteinuria remission at 12 months will be the primary endpoint. Different biomarkers including anti-PLA2R autoantibodies, circulating regulatory T cells, and autoreactive memory B cells will be serially measured to identify predictors of response to therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 70 years
* Free of immunosuppression for at least 3 months
* Capability of understanding the purpose of the study
* Written informed consent

Exclusion Criteria:

* Epidermal growth factor receptor (eGFR) \< 30ml/min/1.73m2
* Kidney Transplant
* Secondary MN (defined on the basis of clinical criteria)
* Type 1 or Type 2 diabetes mellitus (prior diagnosis of gestational diabetes mellitus is not an exclusion)
* History of previous use of Acthar for treatment of nephrotic syndrome
* Prior sensitivity to Acthar or other porcine protein products
* Contraindication to Acthar per Prescribing Information
* Planned treatment with live or live attenuated vaccines once enrolled in the study
* More than three previous treatment regiments
* Participation to other clinical trials over the previous 12 months
* History of cancer, except carcinoma in situ and treated basal and squamous cell carcinomas
* Pregnancy
* Lactation
* Current substance abuse
* Any clinically relevant condition that might affect study participation and/or study results
Xiyanping Injection for the Treatment of New Coronavirus Infected Pneumonia

the investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of Xiyanping injection in patients with 2019-nCoV pneumonia.


Eligibility Criteria:
Inclusion Criteria:

1. Laboratory examination (RT-PCR) confirms the infection 2019-nCoV, which meets the diagnostic criteria for pneumonia (common type) in the New Coronavirus Infection Pneumonia Diagnosis and Treatment Program (Trial Version 6);
2. The patient has a complete hospitalization record that can be used for research.

Exclusion Criteria:

-

Subjects who meet any of the following criteria cannot be enrolled:

1. Suffering from diseases that need to be distinguished from pneumonia infected with new coronavirus, such as tuberculosis, bacterial or viral pneumonia other than new coronavirus pneumonia, hospital-acquired pneumonia, and other pathogenic microorganisms pneumonia;
2. People with basic diseases such as primary immunodeficiency disease, acquired immunodeficiency syndrome, congenital respiratory tract malformations, abnormal lung development, aspiration pneumonia, and lung malignant tumors;
3. According to the judgment of the investigator, the previous or current disease may affect the patient's participation in the trial or the outcome of the study, including: malignant disease, autoimmune disease, liver and kidney disease, blood disease, neurological disease, and endocrine Disease; presently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (HIV) infection, or blood system, or splenectomy, organ transplantation, etc;
4. Pneumonia diagnosed with severe, critically re-associated coronavirus infection or requiring mechanical ventilation or systemic anti-hormonal therapy;
5. Used Chinese patent medicines with similar efficacy as Xiyanping injection during the treatment.
6. The investigator judges that the relevant test or data is missing during the treatment process, which affects the research evaluation or analyst.
The Efficacy of Cranial Electrostimulating Therapy for Depression and Anxiety Among Homeless Adults

This is a trial of the use of cranial electrostimulating therapy for depression and anxiety among homeless adults.

Cranial Electrostimulating (CES) Therapy is a Food and Drug Administration (FDA) approved treatment for depression and anxiety. However, there are no known studies on the use of this device with homeless adults. The objectives of this study are as follows: 1) to evaluate the acceptability and feasibility of CES as a treatment for homeless adults; and 2) to evaluate the efficacy of CES for the treatment of anxiety and depressive symptoms among homeless adults. Participants will be randomly assigned to one of two treatments: sham (n=10) or CES (n=10). Changes in anxiety and depressive symptoms will be evaluated over time.

Eligibility Criteria:
Inclusion Criteria:

* Competent (no legal guardian) males and females between the ages of 18 to 64
* Currently homeless or recent experience of homelessness, and symptoms of anxiety or depression

Exclusion Criteria:

* Younger than 18 and older than 65
* Patients who have attempted suicide with within the past twelve months or have active suicidal ideation will be excluded for possible safety concerns
* Self-reported illegal substance use in the past 30 days. Recent use of nicotine and alcohol will be allowed. However, those with current intoxication will be excluded
* History of a seizure disorder.
* Current history of autoimmune or endocrine disorder affecting the brain, unstable cardiac disease, history of skull fracture, or craniotomy
* Patients with pacemakers or internal electronic devices like deep brain stimulation and cochlear implants
* Women who are pregnant, nursing or planning to become pregnant
* Diagnosis of Schizophrenia or Schizoaffective disorder
MCRcI® Stem Cell Treatment for Diffuse Coronary Artery Disease

Safety evaluation of Intra-Coronary Administration of MCRcI® stem cells in Patients with Diffuse Coronary Artery Disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Diffuse Coronary Artery Disease
* Age 20\~80
* Participants have received proper medication
* Canadian Cardiovascular Society class II- IV Angina.

Exclusion Criteria:

* Age \<20 or \>80
* Pregnant or breast feeding
* Positive adventitious infection (such as HIV, hepatitis )
* History of Myocardial Infarction within past 3 months
* Severe aortic or mitral valve narrowing
* Short of breath unable to receive PCI examination or treatment
* Malignant tumor
* Hematopoietic dysplasia
* Severe organ disease with less than 1 year of life expectancy
* Chronic kidney disease with CCr\<20ml/min
* Kiney disease on renal dialysis.
Patient Insights Following Use of LEO 90100 Aerosol Foam and Daivobet® Gel in Subjects With Psoriasis Vulgaris

To gather insight on how product attributes affect usability by investigating the factors that are thought to influence patient preference to topical anti-psoriatic treatments.

An international, multi-centre, prospective, open-label, randomised, 2-arm, cross-over study with 14-days once daily treatment in subjects with psoriasis vulgaris. To gather insight on how product attributes affect usability by investigating the factors that are thought to influence patient preference to topical anti-psoriatic treatments.

Eligibility Criteria:
Inclusion:

1. At Day 1 (Visit 1), a clinical diagnosis of psoriasis vulgaris of at least 6 months duration involving the trunk and/or limbs amenable to treatment with a maximum of 60 g of study medication per week
2. Psoriasis vulgaris on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) involving 2-30% of the Body Surface Area (BSA) at Day 1 (Visit 1)
3. A Physician's Global Assessment of disease severity (PGA) of at least mild on trunk and/or limbs at Day 1 (Visit 1)
4. A modified PASI (m-PASI) score of at least 2 on the trunk and/or limbs at Day 1 (Visit 1)

Exclusion:

1. Topical anti-psoriatic treatment on the trunk and limbs within 2 weeks prior to randomisation.
2. Any previous topical treatment with calcipotriol plus betamethasone gel (Daivobet® gel or Xamiol® gel).
3. Psoralen combined with Ultraviolet A (PUVA) therapy within 4 weeks prior to randomisation.
4. Ultraviolet B (UVB) therapy within 2 weeks prior to randomisation.
5. Planned excessive exposure of area(s) to be treated with study medication to either natural or artificial sunlight (including tanning booths, sun lamps etc.) during the trial.
6. Subjects who have received treatment with any non-marketed drug substance (i.e. a drug which has not yet been made available for clinical use following registration) within 4 weeks/5 half-lives (whichever is longer) prior to randomisation.
7. Previously randomised into a clinical trial involving LEO 90100.
8. Current participation in any other interventional clinical trial.
9. Previously randomised into this trial.
10. Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis.
11. Subjects with any of the following conditions present on the treatment area: viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections, skin manifestations in relation to syphilis or tuberculosis, acne vulgaris, atrophic skin, striae atrophicae, fragility of skin veins, ulcers and wounds.
12. Other inflammatory skin disorders (e.g. seborrhoeic dermatitis or contact dermatitis) on the treatment area that may confound the evaluation of psoriasis.
13. Known or suspected disorders of calcium metabolism associated with hypercalcaemia.
14. Known or suspected severe renal insufficiency or severe hepatic disorders.
Study of PRO 140 by Subcutaneous Administration in Adult Subjects With HIV -1 Infection

The purpose of this study is:

1. To assess the antiviral activity of PRO 140
2. To assess the safety and tolerability of PRO 140
3. To generate additional PK, PD and safety data of PRO 140


Eligibility Criteria:
Inclusion Criteria:

1. Males \& females, age ≥ 18 years (or minimum adult age as determined by local regulatory authorities)
2. Screening plasma HIV-1 RNA ≥ 5,000 copies/mL
3. CD4+ lymphocyte cell count ≥ 300 cells/mm3 and no documented count \< or = 250 cells/mm3
4. Has not taken any antiretroviral therapy (ART) w/in 12 wks of Early Screening Visit
5. Exclusive CCR5-tropic virus as determined by Trofile™ Assay at Early Screening Visit
6. Clinically normal or "not clinically significant (NCS)" resting electrocardiogram
7. Women of reproductive potential must have a negative serum pregnancy test at Late Screening Visit \& a negative urine pregnancy test w/in 72 hrs prior to first dose of study medication, \& be non-lactating. Male \& female subjects must agree not to participate in a conception process from Early Screening Visit through Day 59.

Exclusion Criteria:

1. CXCR4 tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ Assay.
2. Females who are pregnant, lactating or breastfeeding, or who plan to become pregnant during the study.
3. History of active hepatitis within the previous 24 wks
4. Prior use of any entry, attachment, CCR5 co-receptor or fusion inhibitor, including PRO 140, experimental or approved.
5. Any immunization or vaccination (including influenza vaccine) within 30 days prior to administration of study drug.
Treatment With Crizotinib Single Patient Expanded Access IND 134375

Two year old male with a new diagnosis of Inflammatory Myofibroblastic Tumour. The patient presented with 2 months of intermittent fever and 1-2 weeks of abdominal distention and constipation. An abdominal mass was palpable on exam and US concerning was for neoplasm of abdomen.

Treatment with Crizotinib will be utilized to reduce the size of the lesion and create more optimal tissue plains between vital structures prior to attempted surgical resection would greatly reduce potential morbidity for this patient.


Eligibility Criteria:
Inclusion Criteria:

* This treatment plan is intended for the use of Crizotinib in the treatment of a single patient with Inflammatory Myofibroblastic Tumour

Exclusion Criteria:

* Not applicable as Expanded Access only includes one patient
A Dietary Intervention to Modify Breast Milk Content in Obese Lactating Women

This study is a nutrition research study designed to look at how healthy meals can influence the content of breast milk. Moms will be provided with meals that follow a Mediterranean diet pattern for 4 weeks. The goal of the study is to see if breast milk content changes over the 4 week period. The infants of the moms will also be included in the study to measure any changes in growth.


Eligibility Criteria:
Inclusion Criteria:

* ≤4.5 months postpartum
* BMI 30 - 50 kg/m2
* ≥ 18 years of age
* Singleton pregnancy
* Exclusive breastfeeding and plans to exclusively breastfeed for at least 6 months postpartum
* Mother has a breast pump
* Mother is willing to collect breast milk for a 24 hour period.

Exclusion Criteria:

* Pre-existing conditions (e.g. diabetes, hypertension, heart disease)
* Use of recreational drugs, tobacco, or alcohol
* Use of medications or supplements for which breastfeeding is contraindicated
* Child has internal metal which may be an NMR safety concern
Safety and Feasibility Study of Robotic Assisted Transanal Total Mesorectal Excision for Rectal Cancer

Total mesorectal excision has greatly reduced the local recurrence rate of rectal cancer after colorectal surgery. Transanal total mesorectal excision(TaTME) is potentially a suitable option for patients with middle and low rectal cancer. Robotic systems are expected to develop the advantages of TaTME to overcome the limitations of laparoscopic surgery. This study aimed to investigate the safety and feasibility of robotic assisted transanal total mesorectal excision in patients with rectal cancer.

TaTME is potentially a suitable option for patients with middle or low rectal cancer, especially for males with obesity and a narrow pelvis.The da Vinci robotic system (Intuitive Surgical, Sunnyvale, CA, USA) is expected to overcome the limitations of the laparoscopic transanal approach for rectal surgery. Da Vinci Si Surgical System or da Vinci Xi Surgical System would be used to performed Transanal total mesorectal excision. And the surgery would performed by two-team approach. This study aimed to investigate the safety and feasibility of robotic assisted transanal total mesorectal excision in patients with rectal cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Pathological biopsy confirmed adenocarcinoma of the rectum.
2. Preoperative assessment of tolerance to surgery without major organ dysfunction.
3. Patients must be able to understand and voluntarily sign written informed consent.
4. The surgical method is robotic assisted transanal total mesorectal excision
5. Distance of the edge of the tumour within 8 cm

Exclusion Criteria:

1. The patient cannot tolerate the operation.
2. Refusal to sign informed consent.
3. Patients with distant metastasis of rectal cancer.
4. The surgical method was changed to miles or Hartman;
5. Unable to complete the follow - up
High Intensity Focused Ultrasound (HIFU) for Parathyroid Adenoma

This study aims to determine whether HIFU treatment is a safe and effective alternative to an operation to remove all or part of the affected gland. The objective is to achieve biochemical cure (assessed by normal calcium level in the blood at six weeks, six months and one year after therapy) without affecting the patient's voice or ability to swallow.

Primary hyperparathyroidism is a common endocrine condition in which one or more of the four parathyroid glands in the neck releases too much parathyroid hormone (PTH). this leads to excess calcium in the blood and if untreated it can cause osteoporosis, kidney stone formation, deterioration of kidney function and disturbance in heart rhythm. Surgery to remove all or part of the affected gland(s) is expected to cure 95% of such patients. In current practice all such patients undergo localisation techniques using sestamibi scanning and neck ultrasonography to demonstrate the position of the enlarged/overactive parathyroid gland. These radiological tests are positive in some two thirds of patients, who can be operated through a minimally invasive procedure focused on the exact localisation pinpointed by the scans.

This study uses a procedure that does not require a surgical incision. Precise imaging of the parathyroid glands allows the exact position of the tumour to be found from outside the body. A High Intensity Focused Ultrasound beam produces heat, but only in a small specific area. Exact positioning of the ultrasound beam targets the tumour cells and kills them without harming the surrounding healthy tissues.

Eligibility Criteria:
Inclusion Criteria:

* Primary Hyperparathyroidism (PHPT)
* Moderate/severe hypercalcaemia (Ca\>2.8mmol/L)
* Positive sestamibi scan demonstrating a cervical parathyroid adenoma
* Adenoma visible on ultrasound scan

Exclusion Criteria:

* Large adenoma (\>15mm)
* Deep adenoma (\>20mm from skin surface
* Familial disease (eg members of MEN-1 families)
* Inability to complete questionnaires in English without making mistakes or needing help with translation
Study to Evaluate Safety, Tolerance and Efficacy of ASC22 Combined With ART in Subjects With HIV

This study is a phase II, multicenter, randomized, blind, placebo-controlled to evaluate the safety, tolerance, efficacy of ASC22 injection in combination with anti-retroviral therapy to treat subjects living with human immunodeficiency virus type 1.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and ≤ 60 years old at screening.
* Treated with anti-retroviral medicine continuously for at least 12 months within 6 months of diagnosis of HIV-1 infection.
* Treated with anti-retroviral medicine continuously, contain integrase inhibitor, for at least months before screening.
* CD4+ Cell count ≥300 cells/μL and CD4+/ CD8+ratio ≤ 0.9 at screening.
* Weight ≥ 50 kg at screening.

Exclusion Criteria:

* Known allergy to the drug or excipients used in this trial.
* HIV-associated opportunistic infections in the past 5 years.
* Co-sensors of HBV, HCV, syphilis, etc.
* With bleeding disorders or on anticoagulant therapy.
Metacognitive Therapy for Obsessive-Compulsive Disorder

Cognitive behavior therapy is the most effective treatment of obsessive-compulsive disorder. However, the majority of treated patients remain symptomatic. The metacognitive therapy by Wells (1997) could achieve substantial gains in first pilot studies. The purpose of this study is to investigate this approach with a randomized controlled trial by comparing metacognitive therapy with exposure and response prevention for obsessive-compulsive disorder.

The purpose of this study is to investigate metacognitive therapy by Wells (1997) with a randomized controlled trial by comparing metacognitive therapy with exposure and response prevention for obsessive-compulsive disorder.

Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis: obsessive-compulsive disorder
* German-speaking
* Agreeing to participate, verified by completion of informed consent
* Stable medication (at least 4 weeks)

Exclusion Criteria:

* Current or past diagnosis of substance dependence, psychosis, neurological conditions
* Mental retardation
Patient Reported Outcome Instruments in Sarcoidosis

Evaluate change of quality of life of sarcoiodosis patients over a six months using various quality of life instruments including a monthly smart phone app.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of sarcoidosis by established criteria.
* Patient has completed pulmonary function tests (spirometry) as per standard of care at the enrollment visit.
* Ability to understand and read English at least at a 7th grade level.
* Have access to a computer, iPad, smart phone, or another electronic device that will support the on-line sarcoidosis assessment platform.
* The subject is willing to wear a daily activity and sleep tracker wristband (Fitbit ™ wristband) for 6 months.

Exclusion Criteria:

• Life expectancy of \< 1 year.