cyrilzakka/clinical-trials huggingface dataset:
NIH-AARP Diet and Health Secondary Research Study Based on OH95CN025 Data

Background:

The NIH and the American Association of Retired Persons (AARP) conducted a Diet and Health Study. It studied the links between diet, cancer, and cause of death in a group of middle-aged people in the U.S. Researchers want to learn more about how diet and lifestyle can affect cancer and mortality.

Objective:

To clarify links between diet, lifestyle, cancer, death, and chronic diseases.

Eligibility:

AARP members ages 50 to 71 who took part in study #OH95CN025 and lived in California, Florida, Pennsylvania, New Jersey, North Carolina, Louisiana, Atlanta, or Detroit in 1995 1996.

Design:

This study will use existing data and samples. Participants will not be contacted.

Participants personal data, like name, date of birth, and address, will be used. This data will be kept private. Their data and samples will get a unique ID.

Data from other follow-up studies will be used.

Cancer outcome data will be obtained from the 8 sample areas. Many participants have moved to Arizona, Nevada, and Texas. Data will be obtained from those states as well.

Cause of death and date of death will be obtained from the National Death Index.

Cheek swab samples were gathered from 2004 to 2005. They will be used to study the oral microbiome.

The University of Washington (UW) will be added as a study site. UW will study air pollution.

The process of linking with the Virtual Pooled Registry Cancer Linkage System will be explored. It uses one system. Right now, 11 state systems are used to get and link data.

Paper records will be stored in locked file rooms. Electronic data will be stored on secure servers.

Study Description

The purpose of this study is to analyze the data that have been collected as part of NIH-AARP study (OH95CN025), a historical cohort; in this study we seek to continue to conduct research, but no new study activities will be requested from the study participants.

Objective

To examine relationships between diet, lifestyle, and cancers by means of a prospective cohort design

To examine relationships between diet, lifestyle, and mortality by means of a prospective cohort design

To examine relationships between diet, lifestyle, and chronic diseases

Study Population

Data and samples from 566,398 members of the AARP (formally the American Association of Retired Persons), aged 50-71 years, and who resided in one of six states (California, Florida, Pennsylvania, New Jersey, North Carolina, and Louisiana) or in two metropolitan areas (Atlanta, Georgia and Detroit, Michigan) in 1995-1996

Eligibility Criteria:
* INCLUSION CRITERIA:
* AARP members
* aged 50 to 71 years
* resided in one of six states (California, Florida, Pennsylvania, New Jersey, North Carolina, and Louisiana) or in two metropolitan areas (Atlanta, Georgia and Detroit, Michigan) in 1995-1996
Efficacy of Different Densities of Fractional Carbon Dioxide in Treatment of Post Burn Scars

This study aims to compare effectiveness of different densities of carbon dioxide fractional laser in the treatment of postburn scar.

The study included 25 Egyptian patients with burn scars recruited from the Out Patient Clinic, Dermatology Department, Cairo University. Each has three post burn scars, assigned to monthly fractional Carbon dioxide laser sessions with a total of 3 sessions. parameters are :

Lesion A or part A parameters: 20 W, 800-1000μs dwell time, 2 to 3 stacks according to scar thickness, 900µm spacing (7.4% density).

Lesion B or part B parameters: 20 W, 800-1000μs dwell time, 2 to 3 stacks according to scar thickness, 600µm spacing (12.6% density).

Lesion C or part C parameters: 20 W, 800-1000μs dwell time, 2 to 3 stacks according to scar thickness, 300 µm spacing (25.6% density).

3 mm punch biopsy is taken before and one month after last session for assessment of collagen via (Masson's trichrome strain). In addition clinical evaluation is done via Vancouver \& Patient and Observer Scar Assessment Scale .

Eligibility Criteria:
Inclusion Criteria:

* • Burn scars of at least 1 year duration.

  * Patients with three separate lesions each of them about 2 to 5cm or patients with single lesion equal or more than 8 to 10cm.

Exclusion Criteria:

* • Pregnancy.

  * Lactation.
  * Oral retinoid drugs within the past 6 months.
Elastic Compression in Chronic Venous Disease

Patients with chronic venous disease causing pain or ache will be randomised into two groups, active stockings (18-21 mmHg) or placebo stockings

Patients with chronic venous disease causing pain or ache satisfying the inclusion and exclusion criteria will be randomised into two groups, active stockings (18-21 mmHg) or placebo stockings. The primary outcome of the study (pain/ache scored using a visual analogue scale) and a number of secondary symptoms, signs and rVCSS (revised Venous Clinical Severity Score) will be obtained at baseline and after one week of wearing the active or placebo stocking.

Eligibility Criteria:
Inclusion Criteria:

* Primary varicose veins causing pain/ache located only at the calf level

Exclusion Criteria:

* Venous ulceration
* Dermatitis
* Itching
* Superficial vein thrombosis
* Peripheral arterial disease
* Symptoms of non-venous origin
* Previous use of elastic stockings
Clinical Trial on the Prevention of Thrombocytopenia After First-line Chemotherapy

To assess the efficacy and safety of administration of rhTPO at different time in the treatment of thrombocytopenia caused by first-line GC/GP regimen for non small cell lung cancer (NSCLC)

This is a randomized, controlled, open-labeled, multicenter clinical trial. The subjects are patients with NSCLC who are going to receive GC/GP regimen chemotherapy.

Vadhan-Raj et al conducted a study in which they administered rhTPO in various ways to patients with sarcoma receiving platinum-containing chemotherapy. The results demonstrated that timing of administration of rhTPO can be adjusted according to the occurrence time of nadir platelet values induced by chemotherapy. The timing of administration of rhTPO in this study was determined based on the above proofs.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients at the age of 18 to 75 years old
2. Histologically or cytologically diagnosed NSCLC cases
3. Thrombocytopenia occurred in the selected chemotherapy cycle confirmed by double test results with platelet count lower than 75×109/L
4. Fit for chemotherapy (WBC ≥ 4.0×109/L；neutrophil count\> 1.5×109/L；PLT ≥ 80×109/L；ALT ≤ 3 times the upper limit of normal range；AST ≤ 3 times the upper limit of normal range；TBil ≤ twice the upper limit of normal range；ECOG PS ≤ 2；without severe cardiopulmonary defects)
5. Expected lifespan over 12 weeks
6. With understanding ability and voluntarily sign informed consent form
7. Be able to comply with the study and follow-up process

Exclusion Criteria:

1. With any unstable systemic diseases including active infection, uncontrolled hypertension, liver diseases, renal diseases or metabolic diseases
2. With uncontrolled brain metastasis symptoms (patients whose brain metastasis controlled over 4 weeks without hormone therapy can still be enrolled)
3. With heart cerebrovascular diseases, congestive heart failure with NYHA above II degree, with unstable angina pectoris, with acute myocardial infarction or cerebral infarction within 6 months
4. Breast-feeding or pregnant women
5. Platelet count over 300×109/L
Effect of Yogurt on Minimal Hepatic Encephalopathy

The purpose of this study is to determine whether a special yogurt can improve performance on certain tests of intelligence and decrease liver inflammation in patients with cirrhosis.

Introduction: Cirrhosis is one of the leading causes of death in the United States. Minimal hepatic encephalopathy (MHE) is a significant complication of cirrhosis, which is often not treated because of perceived subclinical nature of this condition and the adverse effects and expense of available medications such as lactulose or rifaximin. There is evidence that small intestinal bacterial overgrowth can contribute to the development of MHE and cirrhosis in murine and human studies. Probiotics are live bacteria that can modify the indigenous intestinal bacterial flora and have been recently used in the treatment of hepatic encephalopathy in patients with cirrhosis.

Our aim is to evaluate the effect of probiotic supplementation via yogurt on liver function and inflammatory markers of bacterial translocation and psychometric test performance in cirrhotic patients with MHE in a prospective pilot trial.

Methods: 30 patients with MHE 2:1 i.e. 20 will be randomized into supplementation with yogurt to be taken 6 ounces twice a day for 60 days and 10 patients will be followed up without yogurt supplementation. All patients will undergo liver function tests, basic metabolic panel, INR, venous ammonia, IL-6 and TNF-alpha at baseline, 30 days and at 60 days. All patients will also undergo psychometric testing with number connection test A, digit symbol test, block design and inhibitory control test at baseline and 60 days. Regular questioning about adherence to yogurt. Collection of yogurt tops as proof of yogurt consumption and review of intake diary will be done at 30 and 60 days from patients randomized to yogurt supplementation.

Importance: There has been only one human study on the modification of gut flora as a therapeutic tool for improvement of MHE in cirrhosis, however that study included alcoholic liver disease and comprised of Chinese patients, therefore etiologies of liver diseases studied were different from those predominant in the United States. Since MHE can adversely affect quality of life and overall prognosis, simple, targeted therapies are needed to treat it. We believe that our pilot study will help delineate human gut flora as a definite target for therapy of cirrhosis and MHE and pave the way for future large-scale studies on this subject.

Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis diagnosed on clinical grounds (within 3 months of enrollment)
* MHE diagnosed by abnormalities in a psychometric battery (NCT-A,BDT,DST and ICT)

Exclusion criteria:

* Current or recent (\< 6 month) use of alcohol
* Co-existing cause of liver dysfunction
* Use of antibiotics within last 6 weeks
* Infection or gastrointestinal hemorrhage within the last 6 weeks
* Hepatocellular carcinoma
* Psychoactive drug use, including interferon concurrently
Evaluation of Respiratory Function During Self-induced Cognitive Trance

The goal of this Prospective, monocentric, non-randomized, open-label study aimed at evaluating the variation of FEV1 during a state of self-induced cognitive trance participant population: Person with expertise in the practice of TCAI can be inclued. (at least 6 months, in order to be able to control the depth of the trance and to have a motor control allowing the realization of a spirometry)

The main question:

Study the significant variation of FEV1 before, during, or after the state of self-induced cognitive trance

Primary objective : Study the significant variation of FEV1 before, during, or after the state of self-induced cognitive trance judgment criteria:

Significant variations in:

PEF PEF25 PEF50 PEF75 FVC Inspiratory capacity, SpO2 Respiratory rate before, during, or after the self-induced cognitive trance state Evolution of the feeling of self-efficacy, assessed by questionnaire

Eligibility Criteria:
Inclusion Criteria:

* Person over 18 years old
* Person with expertise in the practice of TCAI. (at least 6 months, in order to be able to control the depth of the trance and to have a motor control allowing the realization of a spirometry)
* Person affiliated with social security or beneficiary of such a scheme.
* Person having given, in writing, their free and informed consent to participate in the study

Exclusion Criteria:

* Person deprived of liberty by judicial or administrative decision, person subject to a measure of legal protection.
* Exclusion period for other studies
* Person likely, according to the investigator's assessment, not to be cooperative or respectful of the obligations inherent in participation in the study
* Person with a psychiatric, neurological or cardiovascular disease.
* Person with a chronic respiratory disease, for example: asthma, COPD, interstitial lung disease, bronchial dilation, cystic fibrosis,
* Person with a history of exercise-induced bronchospasm.
* Person taking inhaled treatments (corticotherapy, bronchodilators, anticholinergics)
* Pregnant woman (declarative).
The Prevalence of Erectile Dysfunction (ED) and ED Related Quality of Life of Diabetic Men

Adult diabetic patients aged above 20 attending the diabetic clinic of National Taiwan University Hospital are invited to attend a face to face screening and interview. After obtaining the informed consent, questionnaires including IIEF, DAN-PSS-SEX and erectile dysfunction effect on quality of lie are filled.Personal data, status of diabetes control and complications of diabetes are recorded.The results will be used to investigate the prevalence of erectile dysfunction of diabetic men in Taiwan and erectile dysfunction related quality of life change.

Adult diabetic patients aged above 20 attending the diabetic clinic of National Taiwan University Hospital are invited to attend a face to face screening and interview. After obtaining the informed consent, questionnaires including IIEF, DAN-PSS-SEX and erectile dysfunction effect on quality of lie are filled.Personal data, status of diabetes control and complications of diabetes are recorded.The results will be used to investigate the prevalence of erectile dysfunction of diabetic men in Taiwan and erectile dysfunction related quality of life change.

Eligibility Criteria:
Inclusion Criteria:

diabetic male age above 20

Exclusion Criteria:

men using any form of erectile dysfunction treatment-
Probiotics for Liver Cirrhosis With Portal Hypertension

Recent studies indicate that probiotics can stimulate intestinal immunity and tighten the junctions of epithelial cells. By these ways, probiotics can reduce bacterial translocation; hence, they can ameliorate systemic inflammatory status. Because cirrhotic patients with portal hypertension often suffer from infections from intestinal flora, the investigators speculate that probiotics will be beneficial to those patients.

The investigators will recruit appropriate patients, 120 in number, randomly allocate into control and experimental arms. They will be given GK#10 or placebo for 8 weeks. Clinical parameters, such as liver function, renal function, and general conditions will be evaluated at specific time points, week 0, 5, 9, and 13 weeks. Primary outcome measurement will be survival and major complications analysis, and secondary outcome measurement will be liver function evaluation.

The investigators anticipate providing our sponsor with useful results about GK#10. The investigators will make clear the impacts from individual strains, the investigators will validate our speculation that probiotics do no harm to cirrhotic patients with portal hypertension, even be beneficial to them. If the investigators can validate the anticipation, patients can enjoy benefits from our study, and the probiotics may have the potential to sell to the patients in the world.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with history of complications related to liver cirrhosis, including hepatic encephalopathy, variceal bleeding, and spontaneous bacterial peritonitis
2. Patients with evidences of portal hypertension, such as hepatosplenomegaly, thrombocytopenia (\< 100,000/ml)

Exclusion Criteria:

1. Active infection
2. Dialysis patients, myocardial infarction, life-threatening cardiac arrythmia and stroke
3. Hepatocellular carcinoma with life expectancy \< 6 months
4. Portal vein thrombosis
5. in hepatic encephalopathy or liver function ALT \> 3 x UNL, T-bilirubin \> 4.0 mg/dL
6. GI tract bleeding in recent 1 weeks
7. Drug abuser
8. No informed consent
M1 Schizophrenia PET Study

This exploratory study seeks to examine M1 receptor availability in SZ patients and to relate M1 receptor availability to proximal and distal measures of cognitive performance, namely evoked ɣ oscillations in the EEG and verbal memory. Furthermore, the relationship between hippocampal \[11C\]EMO availability (BPND), evoked ɣ oscillations, verbal memory, and measures of illness severity will be explored.

Converging lines of evidence from postmortem studies provide strong evidence that brain muscarinic M1 receptor deficit is present in a subset of schizophrenia (SZ) patients. M1 receptors are an important target for cognitive deficits in SZ. However, until now, it has not been possible to examine the heterogeneity of SZ with respect to M1 receptor availability in vivo. The development of a novel positron emission tomography (PET) ligand, \[11C\]EMO, at Yale PET Center provides a unique opportunity to, for the first time, examine in vivo brain muscarinic M1 receptor availability in SZ and, concurrently, elucidate the relationship of M1 receptors to cognitive deficits in SZ.

The investigators will compare M1 receptor availability in SZ patients and age-, gender-matched healthy controls using \[11C\]EMO and the High Resolution Research Tomograph (HRRT), a PET scanner with high sensitivity and resolution available for human brain imaging. This study will explore the relationship between: hippocampal \[11C\]EMO binding (as a measure of hippocampal M1 AChR availability), encoding-related γ power during a verbal memory task, verbal memory, gender, and serum acetylcholine level. This exploratory study will provide the necessary pilot data to conduct a larger study to fully investigate the heterogeneity of SZ with respect to M1 receptor availability.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18- 65 years that are physically and mentally healthy with the exception of DSM-5 schizophrenia or schizoaffective disorder diagnosis
* Subjects with no metal in the body that may pose a risk during MRI scanning
* No significant medical history, including head trauma and bleeding disorders

Exclusion Criteria:

* Men and women with a history or presence of clinically significant medical conditions
* People who suffer from claustrophobia, have MRI incompatible implants, or other contraindications for MRI and PET scans
Effect of Dopamine on Specific Processing of Shame and Embarrassment in Parkinson's Disease

Shame and embarrassment are two self-conscious emotions frequently experienced by Parkinson's disease (PD) patients. Shame and embarrassment scores strongly correlate with patient's quality of life, anxiety and depression ratings. However, the neurobiology of shame and embarrassment in PD and the influence of dopaminergic replacement therapy (DRT) is poorly understood.

The aim of this study is to characterize how brain structures and neuronal networks involved in Parkinson's disease-related shame, non-Parkinson's disease related shame and neutral control scenarios, are modulated by dopaminergic replacement therapy. For this purpose, functional MRI and connectivity measures between the basal ganglia and shame-related network will be analyzed while PD patients will perform a shame-induction task during both ON- (i.e. during the effect of DRT) and OFF-DRT (i.e. during the withdrawal of DRT) conditions. Correlation with clinical measures will be made.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's disease (PD) based on United Kingdom Parkinson's Disease Society Brain Bank Criteria
* Patients in the PD phase called "motor and non-motor fluctuations stage".
* Presence of motor and non-motor fluctuations are based on:

  1. For motor fluctuations: a score of 1 on item 4.1 and/or 1 on item 4.3 of the Movement Disorder Society Unified Parkinson's Disease Rating Scale IV
  2. For non-motor fluctuations: a score of 2 on item III of the Behavioral Assessment of Parkinson's Disease
* To be on dopaminergic replacement therapy.

Healthy controls:

subjects without any known central nervous system (CNS) lesion or CNS clinical signs on examination

Exclusion Criteria:

* Age greater than 80 years
* Dementia or mild cognitive impairment based on a score \<26 on the MOCA
* Ongoing depression with suicidal ideation
* Any clinically meaningful non-stable renal, hepatic, cardiovascular, respiratory cerebrovascular disease or other serious progressive physical diseases
* Participating in a pharmacological study
* Any MRI contraindications
* Intolerable "OFF" states when the effects of the PD medication wear off (e.g., severe pain, anxiety, depression at the end of the dose or in the morning upon waking)
* Inability to provide informed consent (legal guardianship)
* Inability to speak or read French.
Discontinuation of Primary and Secondary Prophylaxis for Opportunistic Infections in HIV-infected Patients

The purpose of this study is to compare the incidence of opportunistic infections between HIV-infected patients who continue and discontinue primary or secondary prophylaxis for opportunistic infections in whom receiving combination antiretroviral therapy and achieve undetectable HIV-1 RNA, but CD4 cell counts are less than 200 cells/mm3.

Currently, combination antiretroviral therapy (cART) has become the standard of care in the treatment of HIV infection in many parts of the world including Thailand. The benefits of cART represented by an increment of CD4 cell count and a suppression of HIV viral load have been reported worldwide. The National Institute of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the HIV Medicine Association of the Infectious Diseases Society of America (HIVMA/IDSA) recommended discontinuing primary and secondary prophylaxis for prevention of opportunistic infections (OIs) in HIV-infected adults and adolescents receiving cART, when the CD4 cell count increase to a certain level for a certain period of time. For instances, Pneumocystis jiroveci pneumonia (PCP) prophylaxis can be discontinued when patients receiving HAART and CD4 ≥ 200 cells/mm3 for at least 3 months (for primary prophylaxis) or at least 6 months (for secondary prophylaxis), prophylaxis for Cryptococcal meningitis, disseminated penicilliosis, cerebral toxoplasmosis, and disseminated mycobacterium avium complex can be discontinued when patients receiving HAART and CD4 ≥ 100 cells/mm3 for at least 6 months. Our practices follow this guideline. However, recently there are new data showing that there were no cases developed PCP after primary or secondary prophylaxis discontinuation even if CD4 cell count \< 200 cells/mm3. Discontinuation of secondary prophylaxis resulted in reduction in pill burdens that may improve HAART adherence, decrease drug-drug interactions, and also prevent drug adverse events that may happen.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. regularly receiving highly active antiretroviral therapy (HAART) during follow up
3. CD4 cell count \< 200 cells/mm3
4. HIV-1 RNA \< 50 copies/ml after receiving HAART
5. receiving primary or secondary prophylaxis for opportunistic infections including infections caused by Pneumocystis jiroveci, Cryptococcus neoformans, Penicilliosis marneffei, Histoplasma capsulatum, Toxoplasma gondii, Mycobacterium avium complex
6. given written informed consent

Exclusion Criteria:

1) pregnancy