cyrilzakka/clinical-trials huggingface dataset:
EEG Studies of Induction and Recovery From Propofol Induced General Anesthesia

The purpose of this study is to investigate how the commonly used anesthetic drug propofol works in the brain to produce loss of consciousness. While under general anesthesia your brain waves will be measured using electroencephalogram (EEG). On a separate day, the patient's brain will be imaged using magnetic resonance imaging (MRI).


Eligibility Criteria:
Inclusion Criteria:

* Healthy, non-smoking male and female volunteers, ages 18-36 with normal body weight.
* American Society of Anesthesiologists (ASA) physical status I

Exclusion Criteria:

* History of head trauma
* Surgical aneurysm clips
* Cardiac pacemaker
* Prosthetic heart valve
* Neurostimulator
* Implanted pumps
* Cochlear implants
* Metal rods, plates
* Screws
* Intrauterine device
* Hearing aid
* Dentures (which might create NMR artifacts)
* Metal injury to eyes
The Effects of Pharmacotherapy on Brain Mechanisms Underlying Cocaine Dependence.

The overall aim of this project is to use an advanced brain imaging technique, PET, in order to monitor the progress of pharmacotherapy with modafinil or topiramate for cocaine dependence in methadone-maintained patients who use cocaine in addition. Comparisons will be made within the cocaine dependent methadone maintained subjects, between the start and end of treatment, and between the two medications. This is the first systematic research study of pharmacological treatment for cocaine dependence in Israel. This study is of major clinical use, with implications for the treatment of cocaine dependence in poly-drug abusers in Israel. Successful pharmacotherapy for cocaine dependence is expected in reduction in cue-induced subjective craving and in glucose metabolism in brain areas elicited by cocaine craving. Metabolic activity in regions that are activated by craving should be correlated with dopamine DRD2 receptor occupancy in all patients.

SPECIFIC AIMS

1. To try to elucidate the brain mechanisms underlying cocaine dependence and craving in co-morbid cocaine-dependent patients. For this purpose we shall trigger craving for cocaine by exposure to a videotape showing cocaine use and then measure brain metabolic activity using Positron Emission Tomography (PET) and \[18F\] Fluorodeoxyglucose (FDG)
2. To evaluate dopamine binding in the brain in the early stage, and at the end of treatment. For this purpose the patients will undergo brain imaging of the dopamine receptor DRD2 by using PET with \[11C\] raclopride. This is a well established procedure for quantifying the effects of drugs such as amphetamine and cocaine on the brain.
3. To investigate the association between subjective measures of craving for cocaine and the level of dopamine DRD2 receptor occupancy in the brain.

Eligibility Criteria:
Inclusion Criteria:

* Methadone-maintained cocaine-dependent patients use between 1g to 2g a day; 1 to 3 times a week

Exclusion Criteria:

* use more than 2g a day; 5 times a week to everyday
* Subjects who are diagnosed as suffering from psychotic illness according to DSM-IV (Axis 1)22, or with a history of CNS disease, a history of infection that might affect CNS (HIV, syphilis, cytomegalovirus, herpes), or a history of head injury with loss of consciousness,pregnant women.
Bioavailability of Carotenoids and Flavonoids From Fresh Oranges and Orange Juice.

The study was designed as a randomized 2-way cross-over study to assess the bioavailability of carotenoids and flavonoids from sweet oranges and orange juice. Volunteers followed a wash-out period for 2 weeks prior to eating either 400 g of fresh oranges or 719 g of orange juice. The amount of test food was adjusted to deliver an equal amount of β-cryptoxanthin (740 µg). After a consecutive wash-out period of 2 weeks, the procedure was repeated and the volunteers ingested the complementary test food. Blood samples were collected at 8 time points up to 9.5 h after test meal consumption. Additionally, 24 h-urine was collected to evaluate flavonoid recovery.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult men and women
* BMI: 17-60
* Age: 18-65

Exclusion Criteria:

* Women who are lactating or pregnant or plan to be pregnant
* Individuals using tobacco products
* Individuals with metabolic or malabsorption disorders
* Individuals with a history of cancer
* Individuals with a history of liver insufficiency
* Individuals with a history of chronic and lipid metabolism-related diseases
* Individuals with an allergy to oranges
* Obese individuals (BMI \> 30)
A Pilot Evaluation of BLI4700 Bowel Preparation in Adult Subjects

The objective of this study is to evaluate the safety and efficacy of BLI4700 as a bowel preparation prior to colonoscopy in adult patients.


Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female outpatients who are undergoing colonoscopy for a routinely accepted indication.
2. Have previously had a colonoscopy performed
3. At least 18 years of age
4. Subjects must be scheduled for a morning colonoscopy (prior to 12:00PM)
5. If female, and of child-bearing potential, is using an acceptable form of birth control.
6. Negative urine pregnancy test at screening, if applicable
7. In the Investigator's judgment, subject is mentally competent to provide informed consent to participate in the study

Key Exclusion Criteria:

1. Subjects with known or suspected ileus, severe ulcerative colitis, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or megacolon.
2. Subjects who had previous significant gastrointestinal surgeries.
3. Subjects with uncontrolled pre-existing electrolyte abnormalities, or those with clinically significant electrolyte abnormalities based on Visit 1 laboratory results.
4. Subjects with a prior history of renal, liver or cardiac insufficiency
5. Subjects with impaired consciousness that predisposes them to pulmonary aspiration.
6. Subjects undergoing colonoscopy for foreign body removal and/or decompression.
7. Subjects who are pregnant or lactating, or intending to become pregnant during the study.
8. Subjects of childbearing potential who refuse a pregnancy test.
9. Subjects allergic to any preparation components.
10. Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures.
11. Subjects who have participated in an investigational surgical, drug, or device study within the past 30 days.
Supporting Resilience Among Re-entered Seniors

The first goal (Aim 1) of this clinical trial is to learn about specific strengths, challenges, and desired areas of knowledge and skill-building among older adults who re-entered their communities from a period of incarceration and to then develop a new psychoeducational intervention tailored to these older adults. The second goal (Aim 2) of this clinical trial is to test if the intervention increases chronic disease management and whether the intervention is considered appropriate and acceptable by older adults who re-entered their communities from a period of incarceration.

Aim 1 participants will:

* complete a baseline survey
* participate in a focus group

Aim 2 participants will:

* complete a baseline survey
* participate in an 8-week once weekly intervention
* complete three follow up surveys

The protocol for Aim 2 will be developed once the focus group data is analyzed.

Eligibility Criteria:
Inclusion Criteria:

* at least 45 years old
* have re-entered the community from a period of incarceration from jail or prison
* have at least one chronic health condition
* able to speak and understand English

Exclusion Criteria:

* aged 44 or younger
* have not re-entered the community from a period of incarceration from jail or prison
* does not have at least one chronic health condition
* unable to speak and understand English
Evaluation of the Efficacy and Safety of Suppressive Therapy With DALBAVANCINE in Device Infections

The aim of this retrospective observational study is to evaluate the efficacy of antibiotic therapy with dalbavancin in patients presenting with infection on prosthetic devices. The main questions the study aims to answer are:

What is the proportion of patients with early discontinuation of dalbavancin therapy? What are the reasons for early discontinuation of antibiotic treatment? What adverse events do patients report? The study is based on data collected as part of routine care practices.

Translated with www.DeepL.com/Translator (free version)


Eligibility Criteria:
Inclusion Criteria:

* Patients with inextricable and/or inoperable osteoarticular or vascular prosthetic material.
* Patients requiring suppressive antibiotic therapy (\>6 months) with dalbavancin.

Exclusion Criteria:

* Patients who are protected adult;
* Patients who are minors;
* Patients having expressed their opposition
Electrolyte Imbalance Analysis at Intensive Care Unit Admission : Retrospective Study

The type and severity of electrolyte imbalance in patients admitted to the intensive care unit were analyzed.It was evaluated whether these results had an effect on mortality, length of hospital stay, APACHE II scores and ventilator days


Eligibility Criteria:
Inclusion Criteria: all of the ıcu patients -

Exclusion Criteria:

-
Pharmacokinetics of Everolimus and Enteric-Coated Mycophenolatesodium Before and After Withdrawal of Cyclosporine in Renal Transplant Patients

Cyclosporine (CNI), a potent immunosuppressive drug used in transplant recipients to prevent graft rejection, can cause renal impairment in some patients. The aims of this study are

* To determine the influence of CNI discontinuation on the drug exposure and key pharmacokinetic parameters of everolimus and enteric-coated mycophenolate sodium (EC-MPS)
* To determine the adequate dosing of everolimus and EC-MPS in a CNI-free regimen
* To investigate the CNI-free regimen with EC-MPS and everolimus with respect to safety (e.g. rejection rates) and tolerability
* To investigate renal function after CsA withdrawal


Eligibility Criteria:
Inclusion Criteria:

* Patients having a kidney transplant since at least 6 months but for no longer than 5 years.
* Patients in a stable condition in terms of graft function
* Patients currently receiving EC-MPS and CsA with or without corticosteroids as part of their immunosuppressive regimen for at least 1 month prior to Baseline
* Females of childbearing potential must have a negative serum pregnancy test prior to study inclusion. If positive, the patient will not be enrolled. Effective contraception must be used during the trial.

Exclusion Criteria:

* Patients with any known hypersensitivity to EC-MPS or everolimus or other components of the formulation (e.g., lactose)
* Patients with a history of severe rejection (according to BANFF criteria) within 3 months of enrollment in this trial.
* Changes to the immunosuppressive regimen during the last 3 months due to immunologic reasons.
* Patients with thrombocytopenia (platelets \<100,000/mm3), with an absolute neutrophil count of \<1,500/mm3 and/or leukocytopenia (leukocytes \<4,500/mm3), and/or hemoglobin \<9.0 g/dL at baseline.
* Patients with proteinuria at baseline (\> 1g/d)

Other protocol-defined inclusion/exclusion criteria may apply
An Investigation on the Effect of Candesartan on Early Diabetic Nephropathy

It is well understood that hypertension, dyslipidemia, and diabetes mellitus are the major risks of chronic kidney disease. Current guidelines recommend screening kidney estimated glomerular filtration function with serum creatinine. But it is not the utmost effective method and the GFR would be underestimated. Since good correlation was noticed between serum creatinine and chronic kidney disease, urinary microalbumin levels is better for patients with risks of chronic kidney diseases. With adequate and early education, or antihypertensive agents with angiotensin converting enzyme inhibitors (ACEi) or angiotensin II receptor blockers (ARB), all could alleviate renal function deterioration and the severity of proteinuria. As a result, high sensitive methods is urgent and needed for early screening and diseases following up under medication with ACEi and ARB in chronic kidney disease patients. In this project, the investigators are going to include the patients with typy II diabetes mellitus combining with hypertension who are treated with antihypertensive agents. Such volunteers will be treated with Candesartan 8-16mg/ day and maintain systolic blood pressure \<130 mm/Hg, diastolic blood pressure \< 80 mm/ Hg as the goal. Therefore, this project would make effort on correlation with urinary microalbumin and other biomarkers changes under Candesartan treatment- one of ARB medication for 12 weeks, and further exploration of new biomarkers that may be related to renal parenchymal injuries.


Eligibility Criteria:
Inclusion Criteria:

1. Type II Diabetic disease with hypertension (BP: systolic 140-160 mm/Hg, diastolic 80-100 mm/Hg) for 8 weeks.
2. HbA1c\< 8.0%
3. Cre. \<1.5 g/dL and eGFR: 89 - 30 mL/min/1.73 m2

Exclusion Criteria:

1. Pregnancy
2. During the observation, BP: systolic \>160 mm/Hg, diastolic \>100 mm/Hg).
ACCESS A Master Digital Surveillance Protocol for COVID-19

ACCESS enables individuals to contribute to critical research, via an iOS and Android smartphone mobile application. ACCESS combines patient reported outcomes, data from wearable devices and real-world data (such as claims, EHRs, etc), with an opt-in to participate in current and future studies for diagnostics, treatments and vaccines. The data that people share can be quickly and anonymously matched to research studies, providing researchers with a foundational framework for dynamic research at scale and participants a way to be personally matched and prescreened for future research.

In the urgency of the COVID-19 outbreak, Medable will enable an observational study protocol under which clinical trials can rapidly be conducted. The observational study protocol will include the conduct of smartphone based research to capture an essential dataset to improve our understanding of disease evolution, risk factors, and outcomes as well as enable population-based monitoring to reduce the spread of disease. Under this protocol, sub-studies and clinical trials can be conducted for interventions, including vaccine trials. The work may include new tools such as surface environmental or personal swabs to test for presence or absence of disease. Data collection efforts on behalf of rapidly evolving multiple study designs and participant opt-in data sharing, will enable the compilation of critical epidemiological and other data across the United States to accelerate the understanding for effective mitigation and treatment of COVID-19.

ACCESS (American COVID-19 Collaborative Enabling Seamless Science), a novel COVID-19 digital research infrastructure, provides a mobile app tool for participants to report specific data and facilitate remote access to accelerate critical research and clinical treatment development.

ACCESS leverages leading digital health technologies to facilitate at-home research, clinical trials, and population-based long-term outcome studies and data de-identification measures (data coding/tokenization). The infrastructure combines opt-in wearable sensors, patient reported data and outcomes, opt-in data aggregation and additional opportunities for users to participate in clinical trials and share their de-identified data based upon reported information.

Prior to COVID-19, the FDA expressed an interest in expediting drug development through developing trial designs that test multiple drugs and/or multiple subpopulations in parallel under a single protocol, without a need to develop new protocols for every trial. This has become even more important during the COVID-19 pandemic. This type of work will also be enabled under the ACCESS system.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years or older
2. Able to provide electronic informed consent
3. US Resident
4. Read and comprehend English

Exclusion Criteria:

1. Do not have a personal smartphone
Study of YM155 in Refractory Diffuse Large B-cell Lymphoma (DLBCL) Subjects

A study in subjects with a type of B cell lymphoma (DLBCL)to evaluate the response rate, efficacy, safety and tolerability of YM155

1 arm (Active), Phase 2 Study to evaluate response rate, efficacy, safety and tolerability of YM155

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged 18 years or older
* Histologically confirmed primary DLBCL of any stage
* Refractory to the last treatment regimen
* Previously treated with the following treatment regimens:
* Anthracycline-based combination chemotherapy with rituximab
* Second-line combination chemotherapy
* Autologous BMT if the subject was eligible and did not refuse the procedure
* At least one measurable lesion defined as \> 1.5 cm in the longest diameter
* No known central nervous system involvement
* ECOG performance status \< 2
* Life expectancy \> 12 weeks
* If female, non-pregnant and non-lactating
* IRB-approved consent and HIPAA Authorization

Exclusion Criteria:

* Transformed, composite or discordant lymphoma
* Therapy for lymphoma within 21 days prior to the first dose of YM155
* Within 4 weeks of the screening FDG-PET scan, receipt of the following:
* Radiation therapy
* Surgical procedures (except biopsies and central catheter / port placement)
* Active infection (bloodstream or deep tissue)
* Inadequate marrow, hepatic and/or renal function
* Serum creatinine \> 1.5 x ULN or calculated serum creatinine clearance \< 60 mL/min
* Absolute Neutrophil Count (ANC) \< 750/mm3
* Platelet \< 50,000/mm3
* Alanine Transaminase (ALT) and Aspartate Transaminase (AST) \> 2.5 x ULN; \> 5 x ULN if secondary to liver metastases
* Treated with \> 3 prior treatment regimens. The following should be considered:
* Planned maintenance therapy should be considered as part of the previous treatment regimen
* Any preparative treatment (salvage chemotherapy, high-dose chemotherapy, radiation therapy, etc.) should be included with the autologous BMT or PBSCT as one treatment
* Prior allogeneic BMT or PBSCT
* Previously treated with YM155
* Other investigational therapy or procedures within 28 days
* Known HIV, hepatitis B surface antigen, or hepatitis C antibody
* Other malignancy requiring treatment within 2 years
* Significant and/or uncontrolled cardiac, renal, hepatic, or other systemic disorders or significant psychological conditions that in the Investigator's judgment would jeopardize subject enrollment or compliance
LATAM Bif Registry

The LATAM Bif Registy is an international and prospective registry of percutaneous coronary interventions (PCI) in coronary bifurcation lesions. The main goal of the study is to investigate the current state and long-term outcomes of PCI in this complex subset of coronary lesions in Latin America.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years
* Any type of bifurcation lesion
* Side-branch reference diameter \>= 2 mm

Exclusion Criteria:

* Protected left main disease in patients with previous CABG
* Patients who refuse to be included in the registry
Dietary Salt Intake and Vascular Function

The purpose of this study is to look at the effects of high- and low-salt diets on blood vessel function in healthy subjects.

Healthy volunteers will be enrolled in a dietary sodium intervention to examine impact on vascular function.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male, African-American volunteers
2. 18-35 years of age,
3. No personal or first degree relative with hypertension or diabetes,
4. Blood pressure \<130/85 mmHg and \> 90/60 at the screening visit,
5. Body mass index \<30 kg/m2,
6. No clinically significant abnormalities on screening tests (complete blood count, serum electrolytes, liver enzymes, thyroid stimulating hormone, urinalysis and electrocardiogram).

Exclusion Criteria:

1. Alcohol intake \>2 beverage/night,
2. Smoking,
3. Recreational drug use,
4. Personal history of coronary disease, diabetes, hypertension, stroke, kidney disease, or illness requiring overnight hospitalization in the past 6 months,
5. Prescription or herbal medication use,
6. Ischemic changes on resting electrocardiogram,
7. Known hypersensitivity to any of the study drugs,
8. Other active medical problems detected by examination or laboratory testing.
The Registry Study of Genetic Alterations of Oropharyngeal Cancer in Taiwan

We will use the next-generation sequencing (NGS) technology to identify genomic alterations of Taiwanese HPV positive and negative oropharyngeal squamous cell carcinoma (OPSCC) for novel biomarker development and the study design of potential clinical trials or translational research.

In the past decade, next-generation sequencing (NGS) technology has enabled cancer genome sequencing in screening and searching for new cancer genes in an efficient manner. This massive sequencing technique not only help to identify new altered genes for novel biomarker development, but also reveal gene alterations sensitive or resistant to specific therapies. Because the difference of genomic profiling between Taiwanese HPV positive and negative OPSCC is not clear yet, we propose this multi-center research project to address this issue. In this study, we will collect tumor tissues and clinical information from patients with OPSCC and create a platform for data storage and sharing.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 20 and above
2. Pathological reported as squamous cell carcinoma of head and neck
3. Available p16 immunohistochemical staining status (restricted to the OPSCC subgroup)
4. Participants have both archival tumor tissues from the primary head and neck SCC and from the first recurrent tumor (for the recurrence subgroup)
5. Recurrence status is defined as the reappearance of the disease occurring more than 6 months following curative surgery and/or chemoradiotherapy in the recurrence subgroup
6. Willingness to provide archival or newly obtained tumor tissues for current study proposal
7. Life expectancy more than 3 months
8. Patients fully understand the protocol with the willingness to have regular follow-up

Exclusion criteria

1. Inability to cooperate by providing a complete medical history
2. No available tumor tissues for genetic testing
3. Undesirable compliance
4. Having a known additional malignancy that is progressing or has required active treatment within the past 3 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., cervical carcinoma in situ) that have undergone potentially curative therapy are not excluded
Gemeprost Versus Dinoprostone in First Trimester Miscarriages

Comparison between gemeprost and dinoprostone to evacuate first trimester miscarriages.

Women who are diagnosed with first trimester missed miscarriages are invited to participate in the study. They will be randomised to either gemeprost or dinoprostone.

Eligibility Criteria:
Inclusion Criteria:

* missed miscarriages
* incomplete miscarriages
* first trimester

Exclusion Criteria:

* coagulopathy
* Rhesus negative
* suspected ectopic pregnancy or pregnancy of unknown location
* on anticoagulation drug
* septic miscarriages
* hemodynamically unstable