cyrilzakka/clinical-trials huggingface dataset:
Insulin Resistance And End Stage Renal Disease: The Role Of Retinol Binding Protein 4

The purpose of this study is to determine whether Retinol binding protein 4 has a role in insulin resistance development in patients suffering from end stage renal disease on hemodialysis.


Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis for "End Stage Renal Disease group"
* Normal Renal Function for "Control group"

Exclusion Criteria:

* Diabetes
* Malnutrition
* Malignancy
* Acute Infection
* Chronic Active Infection
Preoperative Gabapentin for Chronic Pain After Thoracotomy (GABATHOMIE).

To assess the effects of prolonged preoperative gabapentin treatment (10 days) on chronic pain after thoracotomy.

Randomized, double blind study enrolling 200 adults undergoing thoracotomy. Patients receive either 75 mg hydroxyzine before surgery and placebo 3 times daily for 10 days or 1200 mg gabapentin before surgery continued for 10 days. All patients receive also a thoracic epidural analgesia.

Assessment of chronic pain at 3 month with an evaluation by a physician (pain intensity, pain quality and analgesia requirement).

Assessment of acute pain in the early postoperative period (pain intensity, pain quality and analgesia requirement).

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* elective lung resection via thoracotomy

Exclusion Criteria:

* extended pleurectomy and chest wall resection
* previous ipsilateral thoracotomy
* previous ipsilateral radiotherapy
* thoracotomy for pyothorax
* chest injury
* palliative surgery
* contraindicated placement of a thoracic epidural catheter
* allergy to medications on protocol
* pre-existing pain syndrome
* current treatment with morphine, gabapentin, pregabalin, anticonvulsivants or tricyclic antidepressants
* a history of past or current drug addiction
* severe hepatic, renal or cardiovascular disorders
* inability to understand the study protocol or to answer the questionnaires on pain and quality of life
* severe psychiatric disorders
* incompetent adults under some form of guardianship
* refusal of the protocol
* persons without social security coverage
* pregnant or lactating woman
Evaluation of Neuroendocrine Differentiation as a Potential Mechanism of Tumor Recurrence Following Radiotherapy

This is a pilot study to test a hypothesis that a greater increase in serum chromogranin A (CgA) after a definitive radiotherapy (RT) with or without androgen deprivation therapy (ADT) is associated with a higher risk of prostate cancer recurrence after RT. Serum CgA level is measured before the start of RT and/or the start of neoadjuvant ADT for patients undergoing a definitive RT with or without ADT. CgA is also measured at various pre-defined post-RT time points. The study will analyze the followings: 1. Change in CgA level at various pre-defined post-RT time points from the baseline, 2. Correlation between the extent of post-therapy CgA change and Gleason score of malignancy, 3. Correlation between the extent of post-therapy CgA change and treatment outcome.

Neuroendocrine differentiation (NED) in prostate cancer is a well-recognized phenotypic change by which prostate cancer cells transdifferentiate into neuroendocrine-like (NE-like) cells. Accumulated evidences have suggested that the prevalence of NE-like cells is associated with disease progression and poor prognosis.

NED can be induced by a therapeutic agent. Such therapeutic agents include RT and ADT. RT-induced NED represents a novel pathway by which prostate cancer cells survive radiotherapy and contribute to treatment failure and tumor recurrence. Chromogranin A is the serum biomarker for NED and correlates well with CgA-positive staining in biopsy specimens. It has been reported that elevated serum CgA is associated with poor therapeutic response, androgen-independent growth, and biochemical recurrence.

The study tests whether the extent of serum CgA increase by RT +/- ADT, which reflects radiation-induced NED, is correlated with the risk of prostate cancer recurrence following RT and a Gleason score of prostate carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Clinically localized prostate carcinoma, T1-T4 N0M0, any Gleason Score, any prostate-specific antigen (PSA), or Biochemical relapse with clinically suspicious (based on MRI or clinical examination) or biopsy-proven local recurrence in the prostatic fossa after a radical prostatectomy
* ≥18 years old
* Histologic diagnosis of prostate adenocarcinoma
* Signed informed consent

Exclusion Criteria:

* Biochemical relapse alone without clinically suspicious (i.e. no suspicious lesion on MRI of the prostatic bed) or biopsy-proven local recurrence in the prostatic fossa
* Regional pelvic node metastasis (N1)
* Distant metastasis (M1)
* Concurrent or previous cytotoxic medications
* Medical or psychological conditions that in the opinion of the investigator would not allow follow-up
Preventing Drug Abuse Among Sexual Minority Youth

The planned randomized clinical trial will longitudinally test a tailored, web-based drug abuse prevention program with a nationwide sample of 15- to 17-year-old sexual minority youth (youth who identify as gay, lesbian, bisexual, or unsure of their sexual orientation).

The randomized controlled trial will include at least 890 sexual-minority youth from the United States. Study participants will be 15- to 17-year-old youth recruited from Facebook/Instagram. All youth will complete pretest measures online. Intervention-arm youth will then interact with the 9-session program; youth in the control arm will have access to an attention-placebo website. All youth will then complete posttest measures (immediately following intervention completion and estimated to be approximately 5 months after study onset) and 1-, 2-, and 3-year follow-up measures.

Across posttest and annual follow-up measurement occasions, data analyses will examine rates of 30-day drug use between study arms. The investigators will also examine intervention effects on mediator variables associated with drug use and assess the extent to which changes in mediator variables explain differences in drug use between arms.

Youth assigned to the intervention arm will have access to 9 intervention sessions delivered online. The sessions will be housed on a website with entertainment features youth seek: life hacks, features on LGBTQ leaders, fortunes, horoscopes, inspiring quotes, and health-related resources.

To ensure that youths' expectations for study participation are equivalent across arms and to account for the non-active components of the experimental intervention, the investigators designed the attention-placebo arm. Youth assigned to the attention-placebo arm will have access to the website with entertainment features: life hacks, features on LGBTQ leaders, fortunes, horoscopes, inspiring quotes, and health-related resources.

Eligibility Criteria:
Inclusion Criteria:

* teenagers between the ages of 15-17 years old
* identify as lesbian, gay, bisexual, or unsure of sexual orientation
* speak and read English
* access to a private desktop, laptop, or tablet with broadband internet access

Exclusion:

- Lives outside the United States of America
Clinical Evaluation, Organic Response in Obesity Patients Subjected to Vertical Videolaparoscopy Gastroplasty With or Without Perioperative Cares Recommended by the Acerto Project. Randomized Study.

Background To evaluate clinical results, insulin resistance and inflammatory response to trauma in morbidly obese patients undergoing laparoscopic Sleeve gastrectomy who received either traditional preoperative care or treatment following the ACERTO protocol.

Methods The population of the study consisted of morbidly obese patients, who were operated on with the Sleeve procedure, from Cuiaba, MT, between April and October 2012. We studied the inflammatory response and insulin resistance by measuring levels of glucose, insulin, Homa IR, reactive C protein, albumin, pre-albumin, alpha 1 acid glicoprotein, interleukin 6 and glycosylated hemoglobin. We also studied hydration, nausea and vomiting, hypertension, and length of hospital stay.

Eligibility Criteria:
Inclusion Criteria: We included patients who are between 18 and 45 years of age, from both sexes, with an initial BMI (Body Mass Index) which is equal to or greater than 40 kg/m2, candidates for the sleeve surgery procedure through laparoscopy.

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Exclusion Criteria: We excluded the patients who didn't follow the fasting protocol and also those whose laboratory exams were lost.

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Impact of the Financial Inclusion Improves Sanitation and Health

The goal of this interventional study is to evaluate the impacts of Financial Inclusion improvement sanitation and Health (FINISH) interventions in Kenya's Homa Bay County and Uganda's Kamwenge District among children under five. The main questions it aims to answer are:

1. What is the estimated impact of the FINISH model on health outcomes (diarrhoea occurrence and hygienic behaviour) as well as social (school attendance and sanitation) in the intervention groups?
2. What are the perspectives, attitudes, and practices of various stakeholders (communities, governments, entrepreneurs, and financiers) regarding the FINISH model?
3. What is the cost-effectiveness of the FINISH model, including the amount of leverage funds generated?

The FINISH model postulates that countries will be supported to improve the enabling business environment for sanitation, markets to offer improved safely managed services and products at an affordable price, and formal and informal financial institutions will offer more funding to businesses and households for satiation and hygiene.

Researchers will then compare intervention areas (Homa Bay in Kenya and Kamwenge in Uganda) with control areas (Siaya and Bushenyi in Kenya and Uganda, respectively) to see if the FINISH intervention leads to improved sanitation, health outcomes, and economic benefits.


Eligibility Criteria:
Inclusion Criteria:

* The inclusion criteria for the intervention study involve communities within specific geographic locations (Homa Bay County in Kenya and Kamwenge District in Uganda) targeted by the FINISH Mondial initiative.

Exclusion Criteria:

* to be updated
Binding of Foliglurax to Regions in the Brain in Healthy Participants and in Patients With Parkinson's Disease (PD)

A study to learn how foliglurax binds in regions of the brain

To study binding of foliglurax to mGlu4 receptors in human brain, up to 9 healthy subjects (Part A) and up to 8 patients with Parkinson's disease (Part B) will be injected with a liquid dose of a radiolabelled tracer that allows measurement of foliglurax binding in the brain to determine to which degree foliglurax binds to regions of the brain.

Eligibility Criteria:
Inclusion Criteria:

Part A:

* Healthy subjects
* The subject has a normal structural MRI (sMRI) scan performed in the screening period, as judged by the investigator.
* The subject is, in the opinion of the investigator, generally healthy based on the assessment of medical history, physical examination, vital signs, body weight, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests.
* The subject can tolerate confined spaces for prolonged periods of time.
* The subject is suitable for radial and/or brachial artery blood sampling and cannulation.

Part B:

* Patients with Parkinson's disease
* The subject has a normal sMRI scan performed in the screening period, as judged by the investigator.
* The patient is, in the opinion of the investigator, fit for enrolment in the study based on the assessment of medical history, physical examination, vital signs, body weight, ECG, and the results of the haematology, clinical chemistry, urinalysis, serology, and other laboratory tests.
* The patient has been diagnosed with idiopathic Parkinson's disease for ≥3 years, with a current disease severity of 2 to 4 on the modified Hoehn and Yahr scale in the OFF state.
* The patient has dyskinesia that is not too severe to cause discomfort for the patient during PET imaging and predictable OFF time
* In addition to the above criteria, the patient must, in the opinion of the investigator, also be suitable for the study and the included PET imaging sessions.
* The patient has been receiving a stable regimen of levodopa-containing therapy (total levodopa dose ≤1600 mg per day) (≥3 doses per day of standard levodopa or ≥3 doses per day of carbidopa and levodopa, sustained-release tablets or extended-release capsules of carbidopa and levodopa or benserazide and levodopa), and be on a stable regimen of permitted anti-Parkinsonian drugs (peripheral decarboxylase inhibitors, dopamine agonists \[except apomorphine\], monoamine oxidase type B \[MAO-B\] inhibitors \[except safinamide\], or catechol-O-methyl transferase \[COMT\] inhibitors) for ≥4 weeks prior to foliglurax dosing
* The patient can tolerate confined spaces for prolonged periods of time
* The patient is suitable for radial and/or brachial artery blood sampling and cannulation

Exclusion Criteria:

* The subject has any concurrent disorder that may affect the particular target or absorption, distribution, or elimination of the IMP

Other inclusion and exclusion criteria may apply.
Test Uniformity of Transdermal Drug Delivery to Breast Using Diclofenac Epolamine

The purpose of this study is to look for ways to improve breast cancer treatment by giving breast cancer drugs through the skin of the breast.

The drug used in this study is a diclofenac epolamine patch and is a nonsteroid anti-inflammatory pain reliever. The drug amount that gathers in the breast, after application of a patch to the skin of the breast, will be measured and compared to the amount that is found in the breast when the patch is applied to the skin of the belly.

This is a randomized study where participants in group 1 will apply the diclofenac epolamine patch to the breast and participants in group 2 will apply the same drug to her abdomen. Participants are instructed to apply a new patch every 12 hours for 3 days. Total participation in this study will be for three days, ending on the day of surgery. On the day of surgery, participants will have blood drawn to measure the level of diclofenac epolamine in the body, and the final patch will be removed.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 18 and 80 years, undergoing total mastectomy for, with or without axillary surgery for diagnosis or prevention of breast cancer.
* ECOG performance status less than 2.
* Ability to understand and the willingness to sign a written informed consent.
* Participants must have normal organ and marrow function

Exclusion Criteria:

* Prior history of ipsilateral breast radiotherapy.
* Pregnant women and those who will be actively breast-feeding in the preoperative period will be excluded.
* Inability to discontinue aspirin or warfarin use during the period of participation.
* Known allergy to diclofenac epolamine, or aspirin, diclofenac (Cataflam, Voltaren), or another non-steroidal anti-inflammatory drug (NSAID).
* Renal failure
Test Up Now Education Program

This study will test the effectiveness of an outreach strategy to increase colorectal cancer screening in African Americans. The investigators will recruit 250 African Americans ages 45-64 years who are not up-to-date with colorectal cancer screening or have never been screened, with the goal to evaluate screening knowledge, behavior, and intervention effects on colorectal cancer screening outcomes. Participants will be randomly assigned to the TUNE-UP intervention or a control group. The TUNE-UP intervention arm will utilize a community health advisor to encourage return of stool blood testing kits through cell phone outreach. The control group will receive educational materials about colorectal cancer screening plus a resource list but no community health advisor counseling support or cellphone / text contact. The primary study outcome is receipt of colorectal cancer screening (colonoscopy or Fecal Immunochemical Test) following the intervention. The secondary outcomes will include colorectal cancer screening knowledge, self-efficacy (confidence to receive colorectal cancer screening), intention to screen, and follow-up in the case of an abnormal test result. The research objective is to test the community health advisor intervention effectiveness for promoting stool blood testing as a preferred screening test in an under-screened African American population.


Eligibility Criteria:
Inclusion Criteria:

1. are 45 years to 64 years of age
2. self-identify as African American
3. have a working cellphone or telephone
4. are a resident of Florida
5. are non-adherent with colorectal cancer screening guidelines (i.e., no stool-based tests \> 9 months, no colonoscopy within 9 years, and no flexible sigmoidoscopy within 4 years)
6. have no personal history of colorectal cancer, precancerous colorectal polyps, or inflammatory bowel disease (ulcerative colitis or Crohn's disease).

Exclusion Criteria:

1. under 45 years or over 64 years of age
2. do not self-identify as African American
3. do not have a working cellphone or telephone
4. not a resident of Florida
5. are adherent with colorectal cancer screening guidelines (i.e., stool-based tests \< 9 months, colonoscopy within 9 years, and flexible sigmoidoscopy within 4 years) or
6. have a personal history of colorectal cancer, precancerous colorectal polyps, or inflammatory bowel disease (ulcerative colitis or Crohn's disease).
A Controlled Study of Olanzapine in Children With Autism

This is a 12-week study which investigates the use of olanzapine to decrease disruptive behaviors sometimes associated with Autism in children, aged 3 to 12 years old. The first six weeks of the study are double-blind and placebo controlled, meaning that patients receive either placebo or olanzapine, and that neither the researchers nor the patients know whether or not they are receiving placebo or olanzapine. In the second six weeks all of the patients receive olanzapine. The purpose in using placebo is that it is otherwise impossible to know how effective the drug is or whether or not the drug causes side effects. Patients treated with placebo can have improvement and can have side effects. In the study patients receive a psychiatric evaluation, physical examination, laboratory tests, and study medication (olanzapine or placebo), free of charge.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females, Aged between 3 and 12 years.
2. Autistic disorder - DSM-IV criteria.
3. A score of at least moderately impaired on the CGI-Severity item.
4. Clinical judgment that medication treatment for autism is indicated.

Exclusion Criteria:

1. Rett's disorder, childhood disintegrative disorder, Asperger's disorder, and PDD, NOS.
2. Psychotic disorder (DSM-IV) (including schizophreniform disorder and schizophrenia).
3. Major depressive disorder (DSM-IV).
4. Bipolar disorder (DSM-IV).
5. History of psychoactive drug in the previous 2 weeks prior to phase 1.
6. A history of treatment with olanzapine for a cumulative period of greater than 2 weeks prior to entering phase 1.
7. Systemic diseases such as cardiac, renal, thyroid diseases, uncontrolled seizure disorder (seizure disorder that is not controlled by anti-epileptic medication - a child who is seizure free for a period of 6 months on a stable dose of antiepileptic drug would be considered controlled), or diabetes mellitus.
8. Children with a known medical cause for autistic disorder.
9. Abnormal fasting blood glucose or history of diabetes.
10. Baseline body mass index (BMI) greater than the 90th percentile for age and gender (CDC growth charts, Kuczmarski et al, 2000) (because of risk of weight gain).
11. Baseline QTc \>450 msec. Note: Historically, patients we evaluate do not have QTc values \>450.
12. Dyskinesias at baseline (per the criteria of Schooler and Kane, 1982).
Diagnostic and Monitoring Significance of ctDNA Methylation Analysis by NGS in Benign and Malignant Pulmonary Nodules

AnchorDx is using circulating tumor DNA (ctDNA) methylation analysis by next-generation sequencing (NGS) to develop a blood-based assay for differentiating benign and malignant pulmonary nodules early. The purpose of this study is to evaluate the diagnostic performance of this assay in patients with pulmonary nodules.

This is a prospective, multi-center, observational cohort study and seeks to enroll 10,560 participants with pulmonary nodules smaller than 3 cm in diameter from 21 hospitals in China. All participants will be followed up with chest CT or low-dose computed tomography (LDCT) scans for 2-3 years ( baseline, 3 months, 6 months, 12 months, 24 months and 36 months). Their blood samples, CT or LDCT scans data, and clinical data will be collected at each visit and Formalin-fixed paraffin-embedded (FFPE) tissues will be collected when participants who receive pneumonectomy or percutaneous lung biopsy.

Eligibility Criteria:
Inclusion Criteria:

* 18 Years and older
* pulmonary nodules diagnosed by chest CT or low-dose computed tomography (LDCT) scans

  * non-calcified pulmonary nodules with the diameter between 5mm to 30mm
  * including solid nodules, mixed ground-glass opacity nodules and pure ground-glass opacity lung modules
* new cases of pulmonary nodules or diagnosed within 60 days prior to enrollment
* agree to finish the Patient Pulmonary History Questionnaire
* agree to be followed up for 2-3 years
* agree to provide a written informed consent

Exclusion Criteria:

* pregnant or lactating women
* received any pneumonectomy or percutaneous lung biopsy before enrollment
* recipients of blood transfusions within 30 days prior to enrollment
* patients with tumors identified within 2 years prior to enrollment except non-melanoma skin cancer
* fail to understand or provide a written informed consent