cyrilzakka/clinical-trials huggingface dataset:
Stereotactic Radiotherapy for Oligometastatic Prostate Cancer

This is a study that assesses the safety and efficacy of using stereotactic radiotherapy in conjunction with hormone therapy for patients with metastatic prostate cancer where there are a limited number of metastatic tumours.

Patients will receive androgen deprivation therapy (ADT) for a minimum of 1 year. After this, an intermittent hormone therapy approach will be taken, where ADT will not be restarted until the prostate specific antigen (PSA) reaches a minimum of 10-15 ng/mL. Lupron 30 mg IM will be delivered every 4 months when on ADT.

The prostate (if not previously treated) will be treated to a dose of 35-40 Gy in 5 fractions. All visible nodal metastases will be treated to a dose of 30-35 Gy in 5 fractions. It is very likely that nodal metastases will shrink significantly (often completely) with ADT. In this scenario, the involved nodal regions will be treated to a more modest dose of 25 Gy in 5 fractions (roughly equivalent to a dose of 46 Gy in 23 fractions assuming an α/β value of 1.4). Non-spine bone metastases will be treated to a dose of 30-40 Gy in 5 fractions. Metastases in the brain, spine, lung, liver, and adrenal will be treated according to established stereotactic radiotherapy (SRT) policies at Sunnybrook Odette Cancer Centre. Comprehensive SRT should be delivered within 3 months of starting ADT.

During any "off" period of ADT (before the PSA rises above 10-15 ng/mL), comprehensive SRT can be repeated if there are new oligometastases that become visible. One month after initiation comprehensive SRT, patients will be contacted to assess for acute toxicities.

After completion of radiotherapy to all disease sites, patients will be followed every 3-4 months with PSA testing until the development of castrate resistant prostate cancer. At the same time points, late toxicity and quality of life will be collected for a minimum of 2 years. Computed tomography (CT) of the chest/abdo/pelvis +/- magnetic resonance imaging (MRI) of previously irradiated body sites and bone scan will be performed whenever the PSA reaches ≥ 10 ng/mL (prior to re-starting androgen deprivation therapy during intermittent hormone therapy approach), or at a minimum frequency of once per year.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent.
* ECOG performance status 0-1.
* Histologic confirmation of prostate adenocarcinoma.
* Stage IV disease, with up to 5 metastatic tumours outside of the prostate and pelvic lymph nodes.
* ≤ 3 tumours within any given organ system (e.g. up to 3 brain metastases, or 3 liver metastases).
* All sites of disease are amenable to stereotactic radiotherapy.

Exclusion Criteria:

* Castrate resistant prostate cancer.
* Evidence of spinal cord compression.
* Previous radiotherapy for current cancer (with the exception of upfront management of the primary prostate tumour, brain metastasis(es) prior to androgen deprivation therapy).
* Inability to safely treat all sites of visible disease.
* Prior malignancy within the past 5 years, excluding non-melanoma skin cancer, and in-situ cancer.
The Role of Epigenetic Modifications in Autism Spectrum Disorder

Autism Spectrum Disorder is a neurodevelopmental disorder characterized by impaired social communication and repetitive or stereotyped behaviors. According to the World Health Organization , the prevalence of Autism Spectrum Disorder is one person in 160.

Genetic and non-genetic factors would contribute to the development of autism. However, the molecular mechanisms of ASD are not clear and successful treatments are still under research. Autism Spectrum Disorder can occur due to exposure to environmental pollutants which lead to epigenetic changes like DNA methylation, acetylation and post-translational modifications. However, the role of epigenetic changes in Autism Spectrum Disorder is still debated.

Epigenetic mechanisms represent a link through which environmental factors interact with the genetic factors resulting in modification of Autism Spectrum Disorder risk through changes in gene expression. DNA methylation and histone deacetylation are two major epigenetic mechanisms that regulate the gene expression at successive stages of brain development.

Brain derived neurotrophic factor is responsible for brain development. Altered BDNF levels and expression may be closely associated with Autism Spectrum Disorder. . Glial fibrillary acidic protein is the hallmark intermediate filament protein in astrocytes, the main type of glial cells in the central nervous system. Interestingly, Glial fibrillary acidic protein is a marker of astroglial activation and the recent data indicated that Glial fibrillary acidic protein could be implicated in the pathophysiology of autism. However, the underlying mechanisms for the role of brain derived neurotrophic factor and glial fibrillary acidic protein in autism spectrum disorder are poorly understood.

Eligibility Criteria:
Inclusion Criteria:

1. - All enrolled children with Autism Spectrum Disorder will be:

   1. Exhibit symptoms within the typical triad of autistic traits: communication impairment, social deficits, and ritualistic interests.
   2. Drug-naïve.
2. Children with Autism Spectrum Disorder and controls will be 2-6 years old.

Exclusion Criteria:

The control subjects will also clinically examined by the psychiatrist to exclude any sub-clinical autistic features. Children with Autism Spectrum Disorder and controls will excluded from the study if

1. They receive treatment for any reason.
2. -Endocrinological disease, mental retardation, communication disorder, psychotic disorder, attention deficit hyperactivity disorder and learning disorders seen in the children or their family members.
The Plasma Metabolomics Profiling of Primary Aldosteronism

Primary aldosteronism (PA), characterized by overt renin-independent aldosterone production, is the most common form endocrine hypertension. Compared with blood pressure-matched cases of essential hypertension (EH), PA is associated with a higher risk of cardiovascular morbidity and mortality. It is estimated that PA affects at least 10% of hypertensive patients and up to 25% of treatment-resistant hypertension. The major subtypes of PA are comprised of bilateral idiopathic hyperaldosteronism (IHA) and unilateral aldosterone-producing adenoma (APA). The screening, confirmatory testing, and subtype differentiation of PA for therapeutic management is a multi-step and complex process, resulting in low screening rates and poor clinical recognition.

PA is an independent risk factor for metabolic morbidity. Metabolomic profiling is a relatively new strategy for the diagnosis and prognosis of disease through identification and quantification of various metabolites. In the current study, we aimed to investigate the potential biomakers for discriminating PA from EH, as well as subtype classification for PA, by untargeted metabolomics.


Eligibility Criteria:
Inclusion Criteria:

* According to 2010 Chinese guidelines for the management of Essential hypertension (EH), EH was defined as systolic blood pressure (SBP) ≥140 mm Hg, diastolic blood pressure (DBP) ≥90 mm Hg, and use of antihypertensive medicine within 2 weeks and excluded from PA through ARR or confirmatory testing.
* Patients were confirmed to be diagnosed with Primary aldosteronism (PA) in accordance with the Endocrine Society Clinical Practice Guideline criteria. Patients with an aldosterone-to-renin ratio (ARR) \> 3.7 (ng/dL) further conformed with one of the following confirmatory tests: saline infusion test or captopril-inhibition test. Adrenal CT scans and Adrenal venous sampling (AVS) were performed for PA subtype classification.
* Patients with idiopathic hyperaldosteronism (IHA) were determined based on the absence of obvious adenoma on adrenal CT and bilateral aldosterone overproduction.
* Patients with aldosterone-producing adenoma (APA) were identified based on macroadenoma \>1 cm on adrenal CT, unilateral hypersecretion of aldosterone, and pathological confirmation.
* Signed informed consent and agreed to participate in this study.

Exclusion Criteria:

* other subtypes of secondary hypertension, including renal hypertension, renovascular hypertension, and adrenal hypertension (i.e., pheochromocytoma and Cushing syndrome).
* adrenal cortical carcinoma
* acute infection at the time of assessment
* severe cardiovascular or cerebrovascular disease, liver or renal dysfunction, tumors, autoimmune disease or mental disorders.
* history of adrenalectomy
* alcohol abuse or pregnancy
Comparing Relative Motion Splint and Metacarpophalangeal Joint Blocking Splint for Trigger Finger

The purpose of this study is to compare the effectiveness of relative motion splint and metacarpophalangeal joint blocking splints in terms of sign and symptoms, hand function, occupational performance, and perception of splint wearability (comfort and satisfaction) after six weeks of TF management.


Eligibility Criteria:
Inclusion Criteria:

* single or multiple trigger finger
* unilateral or bilateral trigger finger
* neutral metacarpophalangeal joint position can be attained during passive isolated metacarpophalangeal joint extension of the affected finger

Exclusion Criteria:

* trigger thumb
* steroid injection of the affected finger within last six months
* A1 pulley release of the affected finger.
* history of fracture, tendon injury, nerve injury, Dupuytren's contracture, and other soft tissue injuries of the affected finger or adjacent fingers.
First-In-Human Study Of Single And Multiple Ascending Doses Of PF-06751979

The purpose of this study is to evaluate the safety, tolerability, PK and PD of PF-06751979 following oral doses in healthy adult and healthy elderly subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years or between the ages of 60 and 85 years, inclusive.
* Body Mass Index (BMI) of 17.5 to 32 kg/m2; and a total body weight \>50 kg (110 lbs) at Screening.
* Evidence of a personally signed and dated informed consent document indicating that the subject or a legally acceptable representative has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product.
* Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
* Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.
* Any severe acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
Temozolomide & RT Followed by Dose Dense vs Temozolomide & Retinoic Acid in Pts w/Glioblastoma

Patients have a newly diagnosed brain tumor called a malignant glioma and participate in the study to see if it is possible to increase the benefit of temozolomide when given after radiation. A recent study showed that patients with newly diagnosed glioblastoma lived longer when treated with both temozolomide and radiotherapy followed by 6 months of temozolomide than patients treated with radiotherapy alone. Patients will receive standard low dose temozolomide during radiation. After radiation, they will be randomized to receive either more intense temozolomide or continuous low dose temozolomide.

This is a randomized phase II study that will test two different adjuvant temozolomide regimens in patients with newly diagnosed glioblastoma multiforme. The goal of this study is to identify a regimen that would be appropriate to bring to a phase III trial and compare to the standard dosing regimen of temozolomide recently reported by Stupp et al. in the New England Journal of Medicine. Secondary goals of this study include: prospective analysis of the prognostic impact of MGMT status and generation of preliminary data regarding this treatment strategy for other types of malignant glioma.

The decision regarding which treatment patients receive is made randomly. Neither them or their doctor can select which treatment the patient will receive. There is reason to believe that both of these doses may benefit treating your brain tumor. After 6 months of chemotherapy, and assuming the brain tumor has not shown any sign of growth, they will begin receiving cis-retinoic acid. Cis retinoic acid has been shown in one study to possibly prevent or delay tumor recurrence.

Eligibility Criteria:
Inclusion Criteria:

* Pathologic evidence of a malignant glioma.
* Tissue block or unstained slides must be available for MGMT analysis.
* Age 18-70
* KPS \> 50
* Granulocyte count \>1.5 X 109/L
* Platelet count \>99 X 109/L
* SGOT \< 2.5X upper limit of normal (ULN).
* Serum creatinine \< 2X ULN.
* Bilirubin \< 2X ULN.
* All patients must sign written informed consent.

Exclusion Criteria:

* Any prior chemotherapy, radiotherapy and biologic therapy for glioma.
* Any prior experimental therapy for glioma.
* Other concurrent active malignancy (with the exception of cervical carcinoma in situ or basal cell ca of the skin).
* Serious medical or psychiatric illness that would in the opinion of the investigator would interfere with the prescribed treatment.
* Pregnant or breast feeding women.
* Refusal to use effective contraception.
Smoking and Body Weight: Analysis of HHANES

To evaluate the relationships between smoking rate, gender, and body weight in the Hispanic Health and Nutrition Examination I Survey (HHANES) I. Also, to evaluate the independent and additive contribution of smoking rate and fasting glucose on body weight in HHANES I and NHANES II.

BACKGROUND:

The study was supported by the Small Grants Program established by the National Heart, Lung, and Blood Institute in January 1990 to provide limited support to extend analyses of research data generated by clinical trials, population research, and demonstration and education research studies.

DESIGN NARRATIVE:

The first study used HHANES I data and analysis of variance to determine the possible body composition differences between subgroups of gender and smoking categories. Caloric differences in dietary intake were analyzed in a second ANOVA design.

The second study used data from HHANES I and NHANES II to evaluate the independent and additive or synergistic contribution of smoking rate and fasting glucose on body weight.

Eligibility Criteria:
No eligibility criteria
Mutation of the BTK Gene and Genotype-phenotype Correlation of Chinese Patients With X-Linked Agammaglobulinemia

X-linked agammaglobulinemia (XLA) is a humoral primary immunodeficiency in which affected patients have very low levels of peripheral B cells and a profound deficiency of all immunoglobulin isotypes. Mutations in the gene encoding for Bruton's tyrosine kinase (Btk) are responsible for most of the gammaglobulinemia.

We tend to investigate the gene mutation and clinical features of Chinese X-linked agammaglobulinemia (XLA) patients, and also examined the relationship between specific Btk gene mutations and severity of clinical presentation.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of XLA A.male patients with less than 2% CD19-positive B cells; B.recurrent bacterial infection; C.decreased or absent immunoglobulins in serum

Exclusion Criteria for all groups:

* Presence of other primary immunodeficiency syndromes that do not meet the clinical and laboratory criteria for XLA
Partially Covered and Uncovered Metal Stent for Malignant Distal Biliary Stricture

Endoscopic retrograde biliary drainage with a self-expandable metal stent (SEMS) has been used as a principle palliative method of distal biliary obstruction in patients with pancreaticobiliary cancers. With potentially curative surgical resection being impossible, the maintenance of successful biliary drainage through patent stent has been regarded as the key to improve the quality of life and survival of patient, because it could prevent biliary infection or liver failure, and give patients opportunities for anti-cancer chemotherapy and/or radiotherapy.

Although SEMSs have been reported to be superior to large bore plastic stents in terms of stent patency, they still have some controversial issues to resolve in relation to stent dysfunction and adverse event. It has been widely accepted that covered SEMSs designed to overcome the stent failure of uncovered SEMSs related to tumor ingrowth, have significant higher rate of stent migration as well as tumor overgrowth. Therefore covered SEMSs did not show the clear clinical excellence in the cumulative stent patency over uncovered SEMSs, despite some clinical results of randomized trials favor to covered SEMSs.

From the perspective of adverse events such as pancreatitis and cholecystitis, conflicting results have been produced. It was initially assumed that covered SEMSs could cause the higher incidence of pancreatitis and cholecystitis attributed to occlusion of pancreatic duct and cystic duct by covering materials. However, no significant difference was found with regard to the incidence of pancreatitis and cholecystitis between covered and uncovered SEMSs in several randomized trials and meta-analysis.

The aim of the current study is to compare the cumulative stent patency of partially covered and uncovered SEMS as a primary objective, and investigate overall patient survival, stent dysfunction-free patient survival, and incidence of adverse events including stent dysfunction as secondary objectives.


Eligibility Criteria:
Inclusion Criteria:

1. \> 20 years
2. malignant biliary obstruction, 2 cm distal to hilum
3. unsuitable for curative surgical resection owing to metastasis, locally advanced stage, high operation risk, or patient's refusal
4. expected survival \> 4 months based on Karnofsky performance score.

Exclusion Criteria:

1. history of biliary surgery except cholecystectomy
2. history of SEMS placement
3. coagulopathy (INR\>1.5, Platelet\<50000)
4. duodenal stricture
Effectiveness of Kinesiotaping in Primary Dysmenorrhea

Determine the effectiveness of kinesiotaping on pain in primary dysmenorrhea.

Primary dysmenorrhea is defined as cramping pain in the lower abdomen occurring just before or during menstruation, in the absence of other diseases.

Dysmenorrhea is estimated to occur in 45% to 90% of women of reproductive age. It is a common cause of absenteeism and reduced quality of life in women.

Treatment for dysmenorrhoea aims to relieve pain or symptoms either by affecting the physiological mechanisms behind menstrual pain (such as prostaglandin production) or by relieving symptoms.

First line treatment for dysmenorrhoea is oral contraceptives, non-steroidal anti-inflammatory drugs, paracetamol or aspirin. However these present side effects and some women have contraindications to these treatments. Consequently, it´s necessary to study alternative treatments to drug treatments. Alternative treatments like heat, massage therapy, acupuncture also are used.

The Kinesiotaping uses an adhesive elastic cotton tape color invented by Dr. Kase in the 1970s. It is water resistant and retains its properties up to 5 days.

It has the characteristic to cause elevation of the epidermis and thereby reduce the pressure on the mechanoreceptors below the dermis. This would have the effect of reducing nociceptive stimuli.

Eligibility Criteria:
Inclusion Criteria:

* Women presenting menstrual pain, 4 or more in VAS.
* Have attended gynecological examination in the past 18 months and had ever diagnosed as having a gynecological disorder different from primary dysmenorrhea
* Not have been diagnosed with secondary dysmenorrhea
* Regular menstrual cycles (cycle typical range of 21 to 35 days)
* Do not use an intrauterine contraceptive device (IUD) or taking oral contraceptive pills
* Nulliparous
* Ability to complete questionnaires in Spanish.

Exclusion Criteria:

* Women with mild dysmenorrhea (pain lower 4 in a numeric pain scale range 0-10);
* Women with irregular or infrequent menstrual cycles (outside the typical range of cycle 21 to 35 days);
* Women using an intrauterine contraceptive device (IUD) or taking oral contraceptive pills.
* Women who suffer from diseases diagnosed added
* Women to which it has undergone a surgical procedure for the treatment
* Provide skin lesions in the abdominal wall or in lumbar region
* Use or abuse of drugs or alcohol
Cell-based Assays for Antibody-mediated Transplant Rejection

Goal: The goal of this study is to validate blood tests, which can detect antibody-mediated rejection (ABMR) after renal transplantation. These cell based assays measure CD154-expressing alloantigen-specific B-cells and their subsets in peripheral blood of adult renal transplant recipients. Thirty recipients will be enrolled at two transplant centers, 10 each with ABMR, T-cell mediated rejection (TCMR), and no rejection. Each subject will be sample twice, before and after rejection. Donor-specific anti-HLA antibodies will also be measured with single antigen beads.

This cross-sectional open label study will evaluate whether alloantigen-specific B-cells and their subsets which express CD154 are associated with antibody-mediated rejection after first time renal transplantation in adult recipients.

Control groups include adult renal transplant recipients with T-cell-mediated rejection, and without rejection of any type.

Alloantigen-specific B-cells will be measured after stimulation of recipient peripheral blood leukocytes with those from corresponding donor and HLA-non-identical reference cells.

Thirty total subjects will be enrolled after IRB-approved informed consent, 15 at each of two sites. These subjects will include ten each with biopsy-proven ABMR and TCMR and ten with no rejection.

Each subject will be sampled twice, before and after treatment rejection, at intervals no less than 30 days, and not to exceed 90 days.

B-cells subsets will include those that also express cytokines, and those that are categorized as memory or naive, and their isotope switched or unswitched subsets, transitional B-cells or plasmablasts, etc.

Eligibility Criteria:
Inclusion Criteria:

* IRB-approved informed consent.
* Adults (\>18 yr to 70 years)
* Primary renal transplant recipients with biopsy-proven ABMR, TCMR or recipients with no rejection

Exclusion Criteria:

* Lack of informed consent
* Concomitant BK virus infection
* Vulnerable populations including children \<18 yr, pregnant women, and prisoners