cyrilzakka/clinical-trials huggingface dataset:
A Clinical Research Study Evaluating Ropinirole Treatment For Restless Legs Syndrome (RLS)

A 12-week clinical research study to evaluate the tolerability, efficacy and safety of ropinirole compared to placebo(an inactive sugar pill) in the treatment of patients with RLS in the United States.


Eligibility Criteria:
Â Inclusion criteria:

* Patients diagnosed with Restless Legs Syndrome (RLS).
* Patients diagnosed with RLS (symptoms include an overwhelming urge to move legs usually accompanied by uncomfortable sensations in the legs; usually occur at rest; worse during the evening or night and generally relieved, at least temporarily, by movement).
* Patients must give written informed consent prior to any specific study procedures.

Exclusion criteria:

* Patients with a primary sleep disorder other than RLS.
* Patients with symptoms of secondary RLS (i.e., renal failure, iron deficient anemia, pregnancy) or other movement disorders (i.e., Parkinson's Disease).
* Other inclusion or exclusion criteria to be evaluated by the physician.
Biomarkers for Prognosis of Ambulatory Chronic Heart Failure Patients

Biomarkers representing distinct biological domains including neurohormonal, inflammatory, metabolic-nutritional, oxidative-nitrosative and myocardial injury, might alone or in combination provide prognostic information on mortality in heart failure patients with preserved or impaired systolic function.

Upon enrollment in the study, Troponin I (cTn I), BNP, norepinephrine, plasma renin activity, aldosterone, high-sensitivity C-reactive protein (hs-CRP), tumor necrosis factor-alpha (TNF-alpha), interleukin-6 (IL-6), soluble receptor of interleukin 2 (sIL-2R), leptin, prealbumin, free malondialdehyde, 15-F2t-isoprostane and protein-bound nitrotyrosine were measured in stable ambulatory, non diabetic, elderly heart failure patients. Patients were followed up until death or study termination (31st January 2009).

Eligibility Criteria:
Inclusion Criteria:

* symptomatic congestive heart failure lasting at least six months
* reduced exercise tolerance
* impaired or preserved left ventricular ejection fraction
* cardiomegaly

Exclusion Criteria:

* acute infection
* rheumatoid or other autoimmune diseases
* primary cachectic states (cancer, thyroid disease, severe liver disease)
* severe chronic lung disease
* neuromuscular disorders
* myocardial infarction within the previous 20 weeks
* diabetes mellitus
* chronic renal failure (serum creatinine level \> 2.0 mg/dl, \>177 micromol/L)
Influence of Variable Inflow Volume, Dwell Duration and Glucose Concentration on Ultrafiltration Volume in APD Patients

The purpose of the current investigation is to provide proof of concept for a future approach to improve UF prediction accuracy. While building on the ideas of the past, the concept is augmented by leveraging additional diagnostic technologies and digital data analytics methodologies.

The primary objective of this study is:

- UFV determined per defined dwells with variable dwell duration, dialysis fluid glucose composition and inflow volumes

The secondary objectives of this study are:

* Mean daily UFV
* Defined laboratory parameter like urea, creatinine, glucose, sodium determined in blood and dialysate during the extended PET (in dialysate additionally determination: phosphate, albumin removal)
* Treatment parameter: performed treatment duration and volume
* Fluid status measured by Body Composition Monitor (BCM)
* Manual IPP determination during the extended PET: At the first half of the dwell (during the first hour) for every 20 min and during the second half after 2h, 3h and 4h dwell time
* Residual renal function (RRF): renal urea and creatinine clearance, 24h urine output, Glomerular filtration rate (GFR)
* Extended PET
* 24 h batch collection (including e.g. total peritoneal clearance)
* Analysis of daily dietetic fluid intake, weight and further parameters documented by the patient in a patient diary

Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed and dated by study patient and investigator/ authorized physician
* Patients between 18-65 of age
* Chronic kidney disease (CKD) patients being treated with nocturnal APD for at least 3 months
* Ability to understand the nature and requirements of the study
* Total Kt/V ≥ 1.7 (counting from recruitment of the patient the measurement should not be older than 3 months)
* APD patients using sleep•safe PD-cycler or sleep•safe harmony PD-cycler with an IPP ≤ 18 cm H2O for the fill volume of 120%

Exclusion Criteria:

* Any condition which could interfere with the patient's ability to comply with the study
* Patients who have any condition prohibiting the use of BCM, like patients with major amputations (e.g. lower leg)
* Patients who have been subject to peritonitis/ exit site infection during the last 4 weeks
* Women of childbearing age without effective means of contraception, pregnancy (pregnancy test will be conducted at start and end of study) or lactation period
* Life expectancy \< 3 months
* Patients suffering from uncontrolled/ not well adjustable diabetes
* Recent history of drain related problems, catheter malfunction, or frequent alarms during treatment
* Patients with uncontrolled hypertension and/ or previous history of vascular instability during PD
* Patients treated with intermittent APD
* Participation in an interventional clinical study during the preceding 30 days
* Previous participation in the same study
* APD patients having dwell exchanges throughout the day ("day dwell")
ORACLE-NIRS: Lipid cORe Plaque Association With CLinical Events: a Near-InfraRed Spectroscopy Study

This is a multi-center, investigator initiated study that will prospectively examine treatment strategies and outcomes of patients who underwent clinically-indicated Near Infrared Spectroscopy (NIRS). The information collected will be used to determine the frequency of NIRS imaging performed at the participating sites and to examine the clinical outcomes of the NIRS-detected Lipid Core Plaques (LCPs).


Eligibility Criteria:
Inclusion Criteria:

1. Patients who have undergone/ will be undergoing NIRS imaging at each of the participating centers.

Exclusion Criteria:

None
Colorectal Cancer Associated Host and Microbiome Study

Recruit of healthy, precancer and colorectal cancer patients and record necessary information of demographic and also other messages. All the volunteers were asked to provide samples including stool, blood, urine and tissues. This protocol is performed with the permission of the ethics committee and all the participants were provided with informed consent.

Healthy subjects, precancer patients identified by colonoscopy or colonoscopy history and colorectal cancer patients identified by two independent pathologists will be enrolled. The demographic message including age, weight, height, drug history, family history of all participants will be recorded. Blood, stool and urine samples will be collected of all subjects. Tumor and adjacent tissue samples of colorectal cancer and precancer patients were collected, as well as normal tissue of healthy subjects.

Eligibility Criteria:
Inclusion Criteria

1. individuals who were clear and signed the informed consent.
2. Male and female.
3. Age \>18

Exclusion Criteria:

1. Any one who can not provide accurate information.
2. Any one who denies the study.
3. Younger than 18.
Prevalence of Wildtype Amyloid After TAVR

Those with abnormal vital signs after TAVR need to be willing to obtain a bone scan to evaluate for wildtype amyloidosis. Positive bone scan findings will require evaluation for primary amyloidosis with blood and urine monoclonal immunoglobulin testing. Primary amyloidosis is a different type of disease which requires different treatment.

This research is interested in determining how common wildtype amyloidosis is after transcatheter aortic valve replacement (TAVR). Amyloidosis is a condition characterized by abnormal protein which can accumulate and impair various organs, including the heart. Research suggests that amyloidosis might be common among TAVR patients, but it is a condition that is not routinely evaluated for. We suspect that wildtype amyloidosis may be especially common among patients with abnormal vital signs after their TAVR procedure.

Eligibility Criteria:
Inclusion Criteria

* Patients that underwent a TAVR procedure at the Malcolm Randall VA Medical Center.
* Implant of current generation TAVR (i.e. Sapien S3, Evolut R, or Evolut Pro).
* Willingness to obtain bone scintigraphy if evidence of impaired hemodynamics after valve deployment.
* Willingness to have blood drawn
* Willingness to complete SF12 quality of life KCCQ

Exclusion Criteria:

--Patient that do not qualify for a TAVR procedure as normal clinical care
Open Label Study of NVP+CBV Treatment in Women Who Have Received sdNVP for the pMTCT of HIV

To determine the response to treatment with NVP, ZDV and 3TC in HIV positive women, who previously received NVP for the prevention of mother to child transmission.

An open-label, single arm, multicentre study to determine the virologic and immunologic responsiveness of women, who previously received a regimen of nevirapine for the prevention of MTCT, to a regimen of nevirapine and ZDV+3TC treatment. As well as to evaluate the proportion of patients who fail this treatment at 24 and 48 weeks, and to evaluate the resistance profile of HIV isolates from patients who fail nevirapine and ZDV+3TC treatment.

Study Hypothesis:

When a drug leading to selection of a resistant viral population is withdrawn the original wildtype virus, over time, becomes the predominant virus again. However, low frequency (below level of detection) of drug resistant viral sub-populations may be retained which could mean that the drug resistant variant might reappear rapidly should the same drug be reintroduced as part of combination therapy at a later stage.Therefore this study is proposed to evaluate whether there is an impact of single dose nevirapine for the prevention of MTCT on the subsequent response to a standard HAART regimen that contains nevirapine.

Comparison(s):

trial 1100.1090

Eligibility Criteria:
INCLUSION CRITERIA

* HIV-1-infected non-pregnant women who received a nevirapine regimen, for the prevention of mother to child transmission, at least 12 months previously.
* Women of child-bearing potential must have a negative urine pregnancy test at the screening visit and ensure double barrier methods of contraception, which by definition will in all cases include the use of condoms, throughout the study period.
* CD4 cell count \< 350 cells/mm3 and viral load HIV-1 RNA \> 20,000 c/mL or any symptomatic individual (WHO stage 3) or the presence of any AIDS defining criteria.
* Documented HIV-1 positive status by a licensed HIV-1 ELISA test.

EXCLUSION CRITERIA

* Women who are pregnant or breastfeeding.
* Women with prior exposure to antiretroviral therapy, other than a nevirapine regimen for the prevention of mother to child transmission at least 12 months previously.
* Subjects who in the investigator's opinion are unlikely to complete the 48 week study period or unlikely to comply with the dosing schedule and protocol evaluations.
* Patients with a Karnofsky performance status score \< 70.
* Subjects who fail to meet the HIV treatment criteria (CD4 and viral load) indicated above.
Enduring Happiness and Continued Self-Enhancement (ENHANCE) for COVID-19

This study is a randomized controlled trial of an online, evidenced-based intervention (the ENHANCE program) that was modified to address the health and well-being challenges of COVID-19. Eligible participants will be randomized into the ENHANCE or Wait-List Control group over a 12-week period. ENHANCE participants will be introduced, and asked to practice, 10 evidenced-based principles and skills of happiness and well-being. Participants will complete an online survey about their health and well-being at baseline, midway (or 6 weeks), post-assessment (or at the end of the 12-week study), and 3-months following the end of the study.

The study is designed as a 12-week, two-armed, randomized controlled trail to assess the efficacy of a COVID-19-modified version of the Enduring Happiness and Continued Self-Enhancement (ENHANCE) program. The ENHANCE program represents a 12-week multi-construct, evidenced-based intervention for improving overall happiness and subjective well-being. The ENHANCE program was modified specifically to address the known health and well-being challenges of the COVID-19 pandemic.

Eligible participants will be randomized into either the ENHANCE program or Wait-List Control (WLC) group. ENHANCE participants will be introduced to 10 evidenced-based principles that have been shown to improve health and well-being outcomes. Participants will be further guided to systematically practice these principles in their daily lives using a small-changes approach. WLC participants will be asked to continue life a usual, and provided some additional health and well-being resources that can be accessed online to support current, ongoing distress, if needed.

Participants will be asked to complete an online survey about their emotional, social, and physical well-being at baseline (or at the start of the study), midway (or 6-weeks into the study), and at post-assessment (or at the end of the study period). At the end of the study period, all control participants will also be offered the full ENHANCE program.

Investigators expect that participants receiving the ENHANCE program will show improvements across all negative (e.g., depression, anxiety) and positive (e.g., life satisfaction, quality of life) variables from baseline to post-study. Investigators further expect there to be immediate positive health and economic outcomes linked to active participation in the ENHANCE program (versus the WLC group). Investigators believe the impacts of this research will include (a) mitigating the risk of a severe onset of mental health problems related to anxiety, depression, post-traumatic stress, and suicide, (b) increasing positive mental health and well-being, and (c) increasing physical health in participants across time.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who are fluent in English and are 19 years or older.

Exclusion Criteria:

* N/A
Transcatheter Heart Valve (THV) Sizing and Leakage After Transcatheter Aortic Valve Implantation (TAVI) Before and After Establishing Routine Preprocedure Multi Slice Computerized Tomography (MSCT) Aortic Assessment. A Retrospective Registry Study

The objective of this study is to evaluate the effect of annular sizing strategy (MDCT versus TEE) in transcatheter aortic valve implantation on the prevalence and severity of paravalvular regurgitation.


Eligibility Criteria:
Inclusion Criteria:

* Patients implanted with a THV at Aarhus University Hospital

Exclusion Criteria:

* Learning curve patients (the first 40 patients implanted with a THV device at Aarhus University Hospital, Skejby).
Sinusoidal Obstruction Syndrome for Stem Cell Transplant Patients Biomarker Study

The goal of this is to learn more about stem cell transplant and complications that some people have after their transplants, in particular sinusoidal obstruction syndrome (SOS), also called veno-occlusive disease of the liver.

This is a multicenter, prospective, observational trial. We will measure biomarkers and determine thresholds that will predict increased risk for SOS in pediatric patients receiving HCT or high intensity chemotherapy/irradiation with the future goal of a randomized, interventional, open-label, multicenter trial that will test the preemptive use of defibrotide for prevention of SOS in an enriched high-risk population.

Eligibility Criteria:
Inclusion Criteria:

Age ≤ 25 years undergoing HCT for any reason who fulfill any ONE (1) of the following criteria:

1. History of hepatic disease as defined by:

   1. Viral hepatitis (i.e., hepatitis C virus \[HCV\])
   2. Liver tumor before HCT
   3. Hepatic fibrosis or cirrhosis before HCT as proven by liver biopsy
   4. High aspartate aminotransferase (AST) (\> 2x ULN) before HCT (pre-transplant evaluation)
   5. High alanine transaminase (ALT) (\> 2x ULN) before HCT
   6. High bilirubin (\> 1.2x ULN) before HCT
2. HCT high-risk features including:

   a. Conditioning with high-risk modalities including: i. Busulfan (BU)-containing regimen particularly with oral BU + cyclophosphamide ii. TBI-containing regimen, particularly cyclophosphamide + total-body irradiation (TBI) b. ≥ 2 HCT c. Allo-HCT for leukemia \> or = second relapse d. Unrelated donor (URD) HCT e. Human leukocyte antigen (HLA) mismatch HCT (less than 10 of 10 for bone marrow/peripheral blood stem cell \[BM/PBSC\] or anything less than 6 of 6 for UCB) f. Use of sirolimus + tacrolimus prophylaxis for GVHD
3. High-risk disease states including:

   1. Juvenile myelo-monocytic chronic leukemia (JMML)
   2. Primary hemophagocytic lymphohistiocytosis (HLH)
   3. Adrenoleukodystrophy
   4. Osteopetrosis
4. Other high-risk features including:

   1. Prior treatment with gemtuzumab ozogamicin
   2. Use of hepatotoxic drugs 1 month before HCT and during HCT
   3. Iron overload (i.e., thalassemia/sickle cell) with serum ferritin \> 1000ng/ml
   4. Deficit of ATIII, T-PA (i.e., \< 30% normal values), and resistance to activated protein C if clinical indication (these values do not have to be specifically checked if no clinical history)
   5. Young age \< 2 years but more than 1 month

Exclusion Criteria:

Patients who are transplanted but do not fulfill any of the above mentioned criteria.
Community With Immigrants - a Step on the Road to Employment

The study will investigate if a standard integration programme in combination with a social and health promoting intervention can increase health and well-being among refugee families and influence success with education and employment.

Increased health and well-being can lead to stronger motivation and ability to get involved in education or employment and thereby improve integration of refugee families.

The aim of the study is to investigate the effect of various social and health promoting activities such as physical activity workshops, community gardening, entrepreneurship training, MindSpring course, family excursions and language education on health, well-being, social relations and success with job and education. Increased success with self-sufficiency can support action competence and play a key role in the integration process. Outcome measures are based on self-reporting, biological measures and municipal registry data.

Eligibility Criteria:
Inclusion Criteria:

* Adult refugees aged 18 years and above
* Young refugees aged 13 -17 years
* Must have obtained Danish asylum and live in Naestved Municipality

Exclusion Criteria:

* Physical and/or mental illness which prevents the individual from participating in the integration program offered by Naestved Municipality
* Illness which does not allow collection of a venous blood sample and saliva sample.
Samsung Medical Center-Lymphoma Cohort Study

The purpose of this study is to establish a model which can predict the treatment outcome and the risk of treatment-related morbidity in patients with lymphoma.

Although the cure rate of lymphoma has been increased due to the development of newer effective drugs, a substantial portion of patients is still suffered from relapse. Furthermore, the treatment-related morbidity is another factor which can make the treatment outcome worse in patients with lymphoma, especially elderly patients. Thus, this study is going to assess following factors which amy probably affect the treatment outcome and the risk of treatment-related morbidity.

1. Biologic factors associated with the aggressiveness of lymphoma

   * molecular markers in serum, cytogenetic markers
2. Factors associated with the risk of treatment-related morbidity

   * comorbidity, nutrition status, performance status, quality of life at diagnosis

Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed as lymphoma
* Over 15 years old
* Patients who agreed the enrollment of study
* Informed consent for sampling

Exclusion Criteria:

* Patients who do not want to join the study
IV Sedation Plus TAP Block for Placement of Percutaneous Endoscopic Gastrostomy Tube

Objective: To determine the effectiveness and safety of IV sedation combined with ultrasound-guided, left side transversus abdominis plane (TAP) block versus combination with local anesthetic (LA) infiltration for Percutaneous Endoscopic Gastrostomy (PEG) tube placement.

Background: The procedure used to be done with general anesthesia or IV sedation with LA infiltration, but the use of IV sedation with TAP block may be another option.

Patients and Methods: This was a prospective randomized study including 60 patients, requiring long-term nutritional support, underwent the PEG procedure at the GIT endoscopy unit at our Hospital. Patients were randomly allocated into two equal groups, in group A; procedures were performed with IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP block, while in group B; procedures were performed with IV midazolam and propofol-based sedation with LA infiltration.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring long-term nutritional support
* American Society of Anesthesiologists (ASA) physical status II-III
* Age ≥ 6 years

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status \> III
* Patients younger than 6 years
* Previous PEG placement
* Allergy to local anesthetics
* Patient refusal