cyrilzakka/clinical-trials huggingface dataset:
Pharmacokinetic Study of Single Dose Dutasteride in Healthy Subjects

To monitor the inhibition of 5a-reductase (5AR) enzyme activity at 1, 3, 7, 14, 21, 28 and 42 days following administration of a single dose of dutasteride (2, 3, or 4 mg) by measuring the change in blood levels of 3a-androstanediol glucuronide (3a-diolG) and the ratio of dihydrotestosterone (DHT) to testosterone. To accomplish this aim, an open-label, between-subjects dose comparison study design will be employed with subjects receiving a 2, 3, or 4 mg dosage. Subjects (up to n=40 enrolled to allow a minimum of 24 completers) will be randomly assigned to one of the 3 dose levels. Results of this study will inform the dose selection for a subsequent placebo-controlled, within-subject, crossover study of dutasteride on the effects of alcohol.

A secondary aim of this study is to examine the correlation of a genetic variation in the type I 5AR gene and baseline DHT/T ratio and effect of dutasteride at day 3. A variation in this gene which is one of the targets of dutasteride has been reported to be associated with higher baseline levels of DHT.

Alcohol abuse and dependence remain important public health problems. The chemical mechanisms by which alcohol affects the nervous system are not well understood. Recent theories suggest that alcohol stimulates release of "neuroactive" steroid hormones which are important mediators of alcohol effects. This proposal seeks to identify the most appropriate dosage of an FDA approved medication, dutasteride, which blocks the metabolism of steroid hormones, so that we can use dutasteride as a pharmacologic probe of the biochemistry of alcohol effects in human subjects in a subsequent study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects will be healthy males volunteers who are 21-55 years old and have a BMI \>18.5 and \<32.5. All enrolled subjects will have signed IRB approved consent.

Exclusion Criteria:

* Subjects cannot have a current or past DSM-IV diagnosis of alcohol or drug dependence, current or past 12-months diagnosis of alcohol or drug abuse or major psychiatric disorder, neurological illness, have had a hypersensitivity reaction to dutasteride, physical exam evidence of liver dysfunction, currently be using psychotropic medications or medications that are known to influence steroid hormone levels or metabolism. Nicotine-dependent subjects will be excluded to avoid the confounding effects of nicotine withdrawal during day-long laboratory sessions which are part of the planned alcohol administration study as well as effects of tobacco use on metabolism. Subjects who do not agree to use barrier contraception for 1 week after administration of dutasteride will be excluded
Evaluation of PKU Sphere

A prospective, open-label study of PKU Sphere in patients with PKU following a phenylalanine restricted therapeutic diet.

The rationale for this study is to assess acceptability, adherence and metabolic control in individuals with PKU consuming PKU Sphere, a GMP-based medical food.

The sponsor developed PKU Sphere in response to growing interest in GMP medical foods for the purpose of improving adherence and quality of life by offering an alternative to amino acid based medical foods. PKU Sphere is a powdered, low phenylalanine medical food containing a balanced mix of casein glycomacropeptide (GMP) isolate, essential and non-essential amino acids, carbohydrate, fat, vitamins, minerals and the long chain polyunsaturated fatty acid (LCP); docosahexaenoic acid (DHA). PKU Sphere has been designed for use in the dietary management of Phenylketonuria. It is available in two flavors, Red Berry and Vanilla, packaged in individual serving sachets of 35g and containing 20g protein equivalent (PE).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PKU, identified by newborn screening (NBS) and treated since birth.
* Ages 3 years and above (this includes pregnant women who will be assessed on an individual basis by the Co-Principal Investigators).
* Currently or previously consuming a low phenylalanine diet supplemented with a medical food designed for the dietary management of PKU.
* English as primary language.
* Willingly given, written, informed consent from the participant, 18 or more years, or from the parent/caregiver for participants \< 18 years.
* Willingly given, written assent (if appropriate) for those \< 18 years.

Exclusion Criteria:

* Currently consuming 100% of the medical food component of the diet as PKU sphere.
* An inability, in the opinion of the investigator, to comply with the requirements of the protocol.
* Any other type of inherited metabolic disease.
Diagnosis of Lynch Syndrome Based on Next-generation Sequencing in Patients Meeting Chinese Lynch Syndrome Criteria

The purpose of this study is to find out the proportion of patients diagnosed with Lynch syndrome in colorectal cacner patients meeting Chinese Lynch syndrome criteria. Besides, this study is aimed to analyze the clinical characteristics and germline mutation of Lynch syndrome in Chinese population.

1. Detect germline mutation (by next-generation squencing) in probands.
2. Verify the germline mutation in blood relatives whose proband has known germline mutation(s).
3. Analyze the test data with clinical and family information. Diagnose Lynch syndrome in the included population.
4. Analyze the clinical characteristics and germline mutation of Lynch syndrome in Chinese population.

Eligibility Criteria:
For probands, the inclusion criteria： all of the following three points should be satisfied:

1. One of the colorectal cancer patients from families meeting Chinese Lynch syndrome criteria.

   Chinese Lynch syndrome criteria:

   In a pedigree, there were at least 2 patients with histological-proven colorectal cancer, and among these, at least two patients are first-degree relatives of each other. Besides, any one of the following three points should be satisfied in the pedigree:

   A. at least one patients with multiple primary colorectal carcinoma/adenoma, either synchronously or metachronously.

   B. at least one colorectal cancer diagnosed before 50 years old. C. in the pedigree, at least one patient diagnosed with other Lynch syndrome associated cancer (ie, gastric, endometrial, small bowel, ureter, or renal-pelvic, ovarian and hepatobiliary cancers).
2. With sufficient blood to test;
3. Agree to provide basic information, clinical information and family history of cancer information.

For probands, the exclusion criteria:

With at least one blood relative with known pathogenic germline mutation(s).

For blood relatives verifying germline mutation, the inclusion criteria： all of the following three points should be satisfied:

1. First- to second-degree blood relatives of probands with germline mutation(s).
2. With sufficient blood to test.
3. Agree to provide basic information, clinical information and family history of cancer information.

For blood relatives verifying germline mutation, the exclusion criteria:

Blood relatives who refuse to test.
Incretin and CRTd.

Incretin therapy is a treatment for type 2 diabetes (T2DM) affected by heart failure (HF). In this study the investigators will recruit T2DM patients affected by HF with depressed ejection fraction and treated by Cardiac resynchronization therapy (CRT). These patients will randomly be treated by incretin v/s conventional hypoglicemic drugs. In this patients investigators will report at follow up CRT-d responders rate, mortality, and hospital admission for HF worsening. Incretin may reduce hospital admissions for HF in T2DM v/s conventional hypoglicemic drugs.


Eligibility Criteria:
Inclusion Criteria:

* aged more than 18 years, with clinical hystory of T2DM non insulin dependent, and diagnosed failing heart with depressed ejection fraction; CRTd recipients.

Exclusion Criteria:

* T2DM in insuline therapy; renal impairment, chronic inflammatory and systemic diseases; neoplastic diseases.
This SCR-103 Protocol Will Permit Sites to Proactively Assess TAA, HLA and HPV-16 Status in Patients With Selected Solid Tumors to Determine Suitability for Repertoire Immune Medicines Treatment Protocols.

The purpose of this study is to obtain archived tumor tissue or pre-existing antigen expression data from patients with Head and Neck, Cervical, Melanoma and Non-Small Cell Lung Cancers to assess antigen expression and patient suitability for a Repertoire Immune Medicines Treatment Protocol.

This screening study is intended for men and women at least 18 years of age who have selected advanced solid tumors. The study will assess the patient's selected tumor antigens and/or HPV-16 E6/E7 expression profiles. Human leukocyte antigen (HLA) subtype will also be assessed.

Based on the results, it will be determined if a patient is eligible to be considered for a Repertoire Immune Medicines sponsored clinical trial(s) testing of the safety and efficacy of a multi-antigen cytokine-enhanced T cell therapy. No treatment intervention will occur as part of this screening study.

Upon enrollment, patients will be required to provide archival tumor tissue and saliva samples. Based upon the results of these diagnostic analyses, if eligible, patients may be enrolled in an appropriate interventional clinical trial(s) at the discretion of the Investigator.

Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to provide written informed consent
* Age ≥ 18 years
* Histologically- or cytologically-confirmed, relapsed/refractory, and metastatic or locally advanced head and neck, cervical, melanoma or non-small cell lung cancers. Other solid tumor types may be analyzed at the discretion of the Sponsor
* Able to provide archived tumor tissue or have existing data on TAAs, HPV status or HLA sub-type
* Willing to provide a saliva sample

Exclusion Criteria:

* There are no exclusion criteria for this study.
Efficacy of Cilostazol in Prevention of Peripheral Neuropathy

There are several mechanisms concerning pathophysiology of paclitaxel induced peripheral neuropathy. One of the main mechanisms is induction of Schwann cell dedifferentiation by paclitaxel. At the preclinical level, cilostazol potently inhibited paclitaxel-induced dedifferentiation of cultured Schwann cells, yet this positive effect have not been clinically investigated.


Eligibility Criteria:
Inclusion Criteria:

1. Breast cancer patients who will receive paclitaxel post-anthracycline therapy.
2. Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.
3. Adequate bone marrow function (white blood count ≥4,000/mm3, platelet count≥100,000/mm3), liver function (serum total bilirubin \<1.5 mg/dl), renal function (creatinine \< 1.5 mg/dl).

Exclusion Criteria:

1. Patients with signs and symptoms of clinical neuropathy at baseline.
2. Patients with diabetes mellitus or alcoholic disease.
3. Patients receiving vitamin/ supplementation drugs that interfere with the study intervention.
Evaluating the Effectiveness of a Family Heart Health Educational Program (The FIT-Heart Study)

The primary objective of the FIT Heart Study was to test the effectiveness of a hospital-based standardized screening and educational intervention targeted to family members of patients hospitalized with CVD, to increase adherence to CVD prevention guidelines.

FIT Heart was a randomized controlled trial that tested a novel systems approach to increase adherence to national prevention guidelines among family members of patients hospitalized with CVD. Participants were blood relatives or cohabitants of patients hospitalized with atherosclerotic cardiovascular disease, aged 20-79 years, did not have established cardiovascular disease or diabetes, and spoke English or Spanish. Participants randomized to a special intervention group received behavioral counseling and education on diet and physical activity; personalized risk factor screening and immediate feedback; and reinforcement and follow-up throughout the year. The control group received a brief CVD prevention message in the form of a handout. All participants received standardized assessments of diet, lifestyle, and CVD risk factors at baseline and 1 year (94% follow-up). The main findings have been published showing the mean percent change in LDL-cholesterol level from baseline to 1-year improved in both groups and was not significantly different in the special intervention vs. control group (-1% vs. -2%; p=.64).

Eligibility Criteria:
Inclusion Criteria:

* Life expectancy of at least 5 years after study entry
* Willing to return at Year 1 for a repeat study evaluation
* Family member was hospitalized with acute atherosclerotic cardiovascular disease, including catheter-based procedures and coronary artery bypass grafting
* Speaks either English or Spanish

Exclusion Criteria:

* Established cardiovascular disease, diabetes, active liver disease, or long-term kidney disease
* Life expectancy less than 5 years from study entry
* Prescription of a special diet that is not compatible with the TLC diet
* Participation in a clinical drug study in the 3 months before study entry
* Pregnant or planning to become pregnant
Comparison of Three Methods of Hemoglobin Monitoring

The purpose of this study is to compare the hemoglobin results obtained with 1) the HemoCue™, 2) the Masimo SpHb™, and 3) the UCSF Clinical Laboratory. The goal is to determine if these three values differ from each other during various levels of blood loss in the clinical care of patients for spine revision and hip revision surgery.

See above

Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant female 18 y/o or older
* American Society of Anesthesiology Classification 1, 2 or 3
* Scheduled to undergo spine or hip revision surgery

Exclusion Criteria:

* Pregnant or nursing
* Patients who in the study investigators clinical judgement would not be suitable for research.
Effect of Biological Disease Modifying Anti Rheumatic Drug (bDMARD) Treatment on Spinal Fracture Incidence in Patients With Ankylosing Spondylitis (AS)

Ankylosing spondylitis (AS) is a rheumatoid disease affecting all segments of the axial skeleton, leading to the complete fusion of all spinal segments - the bamboo-spine. During the last decade biological disease modifying anti-rheumatic drugs (bDMARD) have been successfully introduced to reduce the disease activity. It is unclear whether bDMARD treatment had an effect on spinal fracture risk related to AS. This national registry study will investigate the effect of bDMARD treatment on spinal fracture risk in a national cohort of patients with AS.


Eligibility Criteria:
Inclusion Criteria:

* age 30-60 years
* registered diagnosis of ankylosing spondylitis

Exclusion Criteria:

* age \<30 or \>60 years
Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 1 Diabetes Mellitus

Primary Objective:

* To compare the efficacy of a new formulation of insulin glargine and Lantus (overall, regardless the injection time) in terms of change of HbA1c from baseline to endpoint (scheduled Month 6) in participants with type 1 diabetes mellitus

Secondary Objective:

* To compare HOE901-U300 and Lantus when given in the morning or in the evening in terms of:
* Change of HbA1c from baseline to endpoint (scheduled Month 6)
* Change from baseline to endpoint (Month 6) in fasting plasma glucose (FPG), plasma glucose prior to injection of study drug, plasma glucose at 03:00 hours, mean plasma glucose (8-point profiles), glucose variability, treatment satisfaction and health related quality of life in participants with Type 1 Diabetes Mellitus (T1DM)
* Reaching target HbA1c values and controlled plasma glucose (all and reaching target without hypoglycemia)
* Frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (symptomatic, asymptomatic, nocturnal, severe, probable and relative)
* Safety and tolerability of HOE901-U300 including development of anti-insulin antibody (AIAs) during the 12-month study period

The maximum study duration was up to approximately 54 weeks per participants:

* Up to 2-week screening period
* 6-month open-label comparative efficacy and safety treatment period
* 6-month open-label comparative safety extension period
* 48-hour post-treatment safety follow-up period

Eligibility Criteria:
Inclusion criteria:

* Adult participants with type 1 diabetes mellitus

Exclusion criteria:

* HbA1c less than (\<) 7.0% (53 mmol/mol) or greater than (\>) 10% (86 mmol/mol) at screening
* Less than 1 year on any basal plus mealtime insulin and self-monitoring of blood glucose before screening visit
* Participants not on stable insulin dose (+/-20 percent total basal insulin dose) in the last 30 days prior to screening visit
* Participants using pre-mix insulins, human regular insulin as mealtime insulin and/or any glucose-lowering drugs other than basal insulin and mealtime analogue insulin in the last 3 months before screening visit
* Use of an insulin pump in the last 6 months before screening visit and no plan to switch to insulin pump in the next 12 months
* Not willing to inject insulin glargine as assigned by the randomization process once daily in the morning or evening;
* Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit
* Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (example laser, surgical treatment or injectable drugs) during the study period

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Laser InGaAlP (660Nm) to Prevent Radiodermatitis in Breast Cancer Patients Submitted to Radiation Therapy

Breast neoplasm is the second most common type in the world. Radiation therapy is a key component in the treatment of breast cancer. Acute skin reaction is one of the most common side effects of radiation therapy. Several studies were performed for prophylaxis of this adverse event, however, until this moment there is no consensus for clinical practice . Second meta-analysis , the ideal candidate for the radiodermatitis prevention would be an agent capable of repairing damage to DNA or agents that promote cell proliferation . The low power laser promotes tissue repair ( reduces inflammatory phase and induces collagen synthesis ) . Its use in the treatment of adverse events of cancer treatment is well established in two situations : in the prophylaxis and treatment of mucositis and in the treatment of lymphedema . The purpose of this study is to use the low power laser in patients with breast cancer undergoing radiotherapy treatment to evaluate the effects of Laser InGaAIP 660Nm in preventing radiodermatitis.

This study will be a prospective double- blind trial. Patients with breast cancer with stages I-III undergoing to radiotherapy will be included. The participants will be allocated into an intervention group (laser therapy in 26 patients) or a control group ( in 26 patients the laser will be disabled without affecting its apparent function) , five days a week before radiotherapy . The low level laser therapy used in this trial will be Photon Lase III (DMC, approved by ANVISA for medicinal purposes). This InGaAIP laser emits a pulsed 660 nanometer beam with an average output of 80 milliwatts and the average energy density delivered to the breast will be 3 J/cm2. Skin reactions will be graded weekly by a nurse, by a radiotherapist and by an oncologist using the common toxicity criteria (CTC -developed by the National Cancer Institute ) and Acute Radiation Morbidity Scoring Criteria (developed by Radiation Therapy Oncology Group). The patients will answer the modified visual analogue scale for pain (patient self-evaluation).

Eligibility Criteria:
Inclusion Criteria:

1. Age at least 18 years, female gender only.
2. Patients with histological diagnosis of breast cancer (invasive ductal carcinoma, invasive lobular and other types), stages I-III
3. Patients who underwent breast-conserving surgery or mastectomy without breast reconstruction
4. Patients undergoing to adjuvant radiotherapy with conventional dose according to Barretos Cancer's Hospital protocol
5. Patients in the radiotherapy planning , presenting :

   * In the central court : " Hot Spot " ( ICRU ) ≤ 107 %
   * At full volume : " Hot Spot " ( ICRU ) ≤ 110 %

Exclusion Criteria:

* Patients undergoing mastectomy with immediate breast reconstruction
* Patients without histological diagnosis of breast cancer
* Patients with indication for radiotherapy without conventional dose
* Patient with indication for treatment in supraclavicular fossa
* Patients suffering from collagen
* Patients who do not meet the criteria for planning radiotherapy
Improving KIdney Transplantation with Cellular Therapy Study

The i-KITCaT study aims to harness cellular therapies to favourably alter the immunological response to in AKI in transplantation. Kidney transplantation offers the best survival and quality of life outcomes for patients with end-stage kidney disease but requires life-long immunosuppression. Efforts to increase the donor organ pool means accepting kidneys which have been subjected to medical and surgical factors culminating in acute kidney injury (AKI).

There is no treatment to modify the maladaptive injury process following an AKI insult, and this subjects the new kidney to increased risk of needing dialysis in the first 7 days of transplantation, rejection, and shortened transplant survival.

Tolerogenic dendritic cells (TolDC) are currently used in phase I/II clinical trials and are safe for patients receiving a kidney transplant from the same donor as these cells. These trials focus on transplant tolerance, but we will re-purpose TolDCs to favorably alter the disease course following AKI and limit injury following transplantation.

Furthermore, if the patient's own cells (rather than from a third-party donor) can be used, this avoids supply limitations and potential sensitization risk. We will compare the functional characteristics of TolDC generated from control (healthy) and kidney disease (chronic kidney disease (CKD), dialysis and transplantation).

This observational, cohort study will be conducted at Westmead Hospital

* 3 visits over 24-months per participant.
* each consenting participant will donate 20 - 50ml of peripheral blood per visit.
* recruit n = 20 per study group (control, CKD, dialysis, and transplant).

Aims include:

1. Compare generation of therapeutic grade tolerogenic dendritic cells (TolDC) from peripheral blood mononuclear cells derived from controls (healthy) and patients with kidney disease (CKD, dialysis, or transplantation).
2. Perform testing of TolDC phenotype, tolerogenic capacity and yield.
3. Generate hypothesis for different mechanisms of TolDC function not yet described for further characterisation to support future research

Research plan:

* Peripheral blood mononuclear cells (PBMC) will be isolated from blood by Ficoll gradient and ultrapure magnetic bead sorting.
* PBMC will be tested for purity (other unwanted immune cells) and microbiological contaminants before added to specialized DC media to generate TolDC.
* TolDC will have in depth functional characterization including flow cytometry, cytokine expression, genomic sequencing, and in-vitro testing protocols.
* TolDCs will be co-cultured with human renal cells to test protective capabilities across different AKI stimuli/insults.

This allows selection of ideal PBMC donors to generate functionally desirable TolDC for subsequent use in i-KITCaT studies.

Eligibility Criteria:
Inclusion Criteria:

* able to consent, able to provide blood sample

Exclusion Criteria:

* unable to consent, life-expectancy less than 6 months