cyrilzakka/clinical-trials huggingface dataset:
Effect of Stretching Exercises Applied to Diabetes Patients Physiological Parameters

This research will be carried out as a pretest-posttest randomized controlled study to determine the effect of stretching exercises performed 2 days a week for 12 weeks for one hour each session on physiological parameters and treatment compliance in individuals with diabetes.

This research will be carried out as a pretest-posttest randomized controlled study to determine the effect of stretching exercises performed 2 days a week for 12 weeks for one hour each session on physiological parameters and treatment compliance in individuals with diabetes.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Those who have been diagnosed with diabetes and have been on the same diabetes treatment for at least three months
3. Non-pregnant
4. Those who agreed to participate in the research
5. Those without any physical exercise disability

Exclusion Criteria:

1. Illiterate
2. Persons with severe mental disorders
3. Those who do not wish to answer the survey questions
4. Those who do not agree to participate in the research
Decision Aid for Gastroesophageal Reflux Disease Management

The study is to test a decision aid that is designed to help patients make decision regarding management of their gastroesophageal reflux disease (GERD). Once the decision aid is constructed we will test and assess the aid on \~100 patients who have GERD to assess effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* Patients with GERD,
* Age at least 18,
* Able to give consent

Exclusion Criteria:

* Unable to perform decision aid on a computer
BIS and Entropy in Deep Brain Simulation

The main objective of the study is to determine whether depth of anesthesia (DOA) monitoring such as Bispectral Index (BIS) and entropy are accurate in patients with neuro-psychological conditions such as Parkinson's disease by comparing these monitoring with standard clinical monitoring like heart rate, blood pressure and respiratory rate.

Deep brain simulation (DBS) is an increasingly popular treatment for movement and psychiatric disorders such as Parkinson's disease and dystonia. These patients are quite sensitive to anesthetics and use of depth of anesthesia monitors are often needed to titrate the anesthetics. The calibration of BIS and entropy monitors has been done only on subjects with no neurological diseases. The investigators plan to record BIS and entropy readings during general anesthesia (GA) for the internalization of DBS electrodes. This would be useful as there are very few studies in this subset of patients with regards to DOA monitoring. Ashraf argued that the EEG may be altered under these circumstances and hence produce invalid BIS readings. Pemberton et al. studied patients undergoing tumour surgery using a sleep- awake-sleep anaesthesia technique. They found a poor correlation between BIS values and the observer's assessment of anesthesia level, suggesting that BIS is not a reliable tool for patients with brain abnormalities. The purpose of this study was to investigate whether BIS and entropy are helpful in titrating DOA in patients undergoing neurosurgical procedures or suffering from neurological diseases as they were frequently excluded from validation studies of the BIS monitoring device.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients older than 18 years of age scheduled for elective internalisation of DBS electrodes under general anesthesia.

Exclusion Criteria:

* lack of informed consent
* language barrier
* those that are transferred to an intensive care unit postoperatively.
Efficacy Study of TKcell in Advanced Colorectal Cancer

The purpose of this study is to determine efficacy of NKCell in colorectal cancer


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Diagnosis of histologically confirmed adenocarcinoma of the colorectal
* ECOG performance status of 0 - 2
* At least one definite measurable lesion(s): ≥ 1 cm on spiral CT scan or ≥2cm in physical examination
* Adequate liver, renal, bone marrow functions as evidence by the following;
* Absolute neutrophil count \> 1.5 x 109/L; platelets \> 7.5 x 109/L; Bilirubin less than 2 mg/dL ASAT and/or ALAT \< 5 UNL; serum creatinine ≤ 2 ULN
* Minimum life expectancy of 12 weeks
* Effective contraception for both male and female subjects if the risk of conception exists

Exclusion Criteria:

* Brain metastasis and/or leptomeningeal disease (known or suspected)
* Previous chemotherapy for gastric cancer except adjuvant treatment with progression of disease documented \> 6 months after end of adjuvant treatment.
* Previous oxaliplatin-based chemotherapy
* Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to randomization and chemotherapy
* HIV antibody (+), Chronic hepatitis
* Uncontrolled infection
* Concurrent or previous chronic systemic immune therapy, targeted therapy, hormonal therapy not indicated in the study protocol except for contraception
* Clinically relevant coronary artery disease, history of myocardial infarction, high risk of uncontrolled arrhythmia
* Known hypersensitivity reaction to any of the components of the treatment.
* Pregnancy (absence to be confirmed by ß-hCG test) or lactation period
* Participation in another clinical study within the 30 days before randomization
* Significant disease which, in the investigator's opinion, would exclude the subject from the study
Effect of DASH Eating Pattern on Heart Failure Outcomes

The objective of the study is to examine the effect of nutritional intake on cardiometabolic, inflammation, and physical function markers in advanced heart failure patients using a one-group pre-post test design feeding trial. Effects on hemodynamic markers will be assessed in a subsample of patients with implanted hemodynamic monitoring devices (CardioMEMS). The pre-test condition is represented by participants' self-selected diet, and the post-test condition is represented by a prescribed Dietary Approaches to Stop Hypertension (DASH) diet.


Eligibility Criteria:
Inclusion Criteria:

1. 18+ years of age
2. English language literacy
3. Diagnosis of HF ≥ 3 months
4. Diagnosis of NYHA Class III HF (historical assessment)
5. Subjects must be stable on HF medication regimen for one month prior to study entry
6. At least 1 HF hospitalization within 24 months of enrollment
7. BNP \>200 pg/ml

Exclusion Criteria:

1. Subjects who have had an unplanned HF-related hospitalization within 2 months of enrollment
2. Subjects with a Glomerular Filtration Rate (GFR) \<25 ml/min who are nonresponsive to diuretic therapy or who are on chronic renal dialysis
3. Subjects likely to undergo heart transplantation within 2 months of enrollment
4. Subjects with severe conditions limiting 6-month survival
5. Unavailability during scheduled data collection points
6. Cognitive impairment
The Renin-Angiotensin System in Essential Hypertension

Although ACE Inhibitors and Angiotensin Receptor Blockers are effective blood pressure lowering agents, the exact mechanisms by which these agents lower BP are still not fully understood. This study aims to compare the blood pressure and hormonal responses (plasma renin activity and aldosterone) to the ACE inhibitor enalapril and ARB candesartan in individuals with mild essential hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Essential Hypertension
* SBP 140-159 mmHg
* DBP 90-99 mmHg

Exclusion Criteria:

* Intolerance of or allergy to ACE Inhibitors or ARBS
* Pregnant or Breastfeeding
* Pre-menopausal women
* Uncontrolled cardiac or renal failure
* Diabetes mellitus
Simplification to Atazanavir/Ritonavir + Lamivudine as Maintenance Therapy

A switch to a regimen consisting of ATV/RTV 300/100 mg QD + 3TC 300 mg QD in HIV-1 infected subjects in their first antiretroviral regimen and who are virologically suppressed on a regimen which consists of 2 NRTIs + any 3rd agent, is non-inferior to continue or switch to ATV/RTV 300/100 mg QD + 2 optimized NRTIs for maintenance of virological suppression.

Clinical Trial, phase IV, randomized, open label, multicenter with approved drugs in their use conditions.

A switch to a regimen consisting of ATV/RTV 300/100 mg QD + 3TC 300 mg QD in HIV-1 infected subjects in their first antiretroviral regimen and who are virologically suppressed on a regimen which consists of 2 NRTIs + any 3rd agent, is non-inferior to continue or switch to ATV/RTV 300/100 mg QD + 2 optimized NRTIs for maintenance of virological suppression.

Eligibility Criteria:
Inclusion Criteria:

* Signature of informed consent
* At least 18 years old
* Patients on their 1st ARV treatment consisting on 2 NRTIs + 1 third agent for at least 1 year
* Undetectable viral load for at least 6 months prior to inclusion in the study (VL\<50 c/mL in 2 determinations 6 months apart; blips are not allowed).
* Requirement of ARV treatment change due to toxicity, intolerance or simplification.
* Clinically stable.

Exclusion Criteria:

* Pregnant women or women who plan to get pregnant during the study.
* Breast feeding
* History of change of any ARV treatment component for any reason 4 months prior to the inclusion in the trial
* History of ARV treatment change due to virological failure
* History of confirmed virological failure defined as one single VL \>400 c/mL or at least 2 VL between 50 and 400 c/mL one year after an indetectable VL was achieved.
* Absence of HIV genotype prior to ARV treatment initiation.
* Resistance mutation to any of the study drugs (ATV, RTV, 3TC)
* HBV infection.
* History of toxicity or intolerance to ATV, RTV or 3TC.
* Gilbert's syndrome.
* Use of contraindicated drugs.
* Lab abnormalities grade 4.
Physical Activity of Staff on Medical Duty in a Department of Anesthesia and Critical Care During Guards

On-call work is an integral part of senior and junior patricians in a critical care department.

Several studies have examined the effect of sleep deprivation on physicians on call and the impact of sleep deprivation on the quality of patient care.

Some of these studies have shown that practitioners' concentration capacities have deteriorated as the guard progresses.

However, few studies have looked at the physical activity of practitioners over a period of on-call time (distance covered, number of steps,...), as well as other parameters than the time spent in communication over the telephone.

The age and seniority of practitioners seem to be factors that can influence these different parameters, and there are few figures in the literature.

Practitioners and juniors will be informed of the study. If they agree to participate in the study, each volunteer will receive an assessment of their cognitive functions before taking up their duties via the Montréal Cognitive Assessment (MOCA) version 7.1.

The place of exercise (emergencies, anaesthesia and ICU Each participant will be equipped with a connected watch with pedometer and cardiofrequencemeter function (Fitness Tracker F07Max).

During his on-call period a questionnaire will be given to him, with socio-demographic data, sleep duration and quality and the number of acts during the on-call period.

The telephone data will be analysed by querying the internal telephone system of the Reims University Hospital.

At the end of the on-call period, the analysis of the data from the connected watch will be analyzed and each volunteer will benefit from an evaluation of his cognitive functions via the Montreal Cognitive Assessment (MOCA) version 7.3 after taking up his duties.

Data will be collected during 2 shifts for each practitioner and junior

Eligibility Criteria:
inclusion criteria :

- voluntary practitioners and residents of the critical care department (intensive care, emergencies and anaesthesia)

exclusion criteria :

* refusal to participate
* musculoskeletal disorders
* a significant medical history that prevents normal physical activity for age
A Study To Examine The Effects Of PF-04958242 On Ketamine-Induced Cognitive Impairment In Healthy Volunteers

To assess if PF-04958242 can attenuate the ketamine-induced cognitive impairment in verbal learning and memory, episodic memory and spatial working memory in healthy volunteers.

This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects 21 - 45 years old.
* Able to read and write English as primary language.
* Subjects who are willing to comply with study procedures.

Exclusion Criteria:

* History of any substance abuse or dependence disorder meeting DSM-IV criteria and/or by SCID-NP within the past 12 months, with the exception of nicotine.
* Known sensitivity to ketamine
* Any history of DSM-IV Axis I psychiatric disorders, determined by SCID-NP interview or diagnoses in the view of the investigator.
Intensive Postpartum Antihypertensive Treatment

The long-term goal of our work is to evaluate the effect of intensive postpartum blood pressure control on maternal cardiovascular health, risk of chronic hypertension, and reversal of vascular dysfunction generated by hypertensive disorders of pregnancy, thus attenuating the lifelong trajectory of cardiovascular disease risk.

The IPAT will randomize 60 postpartum patients with HDP at the Medical College of Wisconsin (MCW) to intensive BP control with Nifedipine extended release (ER) (target BP \<140/90 mmHg) versus usual care (target BP \<150/100 mmHg). Oversampling of Black patients with HDP will be done to ensure they comprise 50% of study participants. Patients enrolled in both arms will undergo education on healthy lifestyle following AHA "Life's Essential 8" (LE8) of tobacco cessation, physical activity, healthy sleep, and healthy diet with detailed overview of DASH throughout the first year postpartum with monthly virtual educational session delivered by a registered dietician and a life coach. Assessment of LE8 CVH score will be done after delivery, 6 weeks postpartum, and 12 months postpartum. Participants will also undergo vascular function assessment: endothelial dysfunction with brachial artery flow mediated dilation (FMD), arterial stiffness with carotid-femoral pulse wave velocity (cfPWV) and anti-angiogenic and inflammatory CVD biomarker with soluble fms-like tyrosine kinase (sFlt-1), at baseline, 6 weeks, and 12 months postpartum. The primary outcome is feasibility of all study procedures, including recruitment, retention, and adherence. Secondary outcomes are change in BP, CVH score, FMD, PWV, and sFlt-1 from baseline to 12 months postpartum.

Eligibility Criteria:
Inclusion Criteria:

* HDP diagnosis (gestational hypertension or preeclampsia) according to ACOG guidelines
* Postpartum day 0-3 and prior to discharge
* Able to communicate in English or in Spanish
* Age 18 - 45

Exclusion Criteria:

* Pre-gestational hypertension
* Pre-gestational diabetes ( type 1 or type 2)
* Intent to transfer postpartum to an outside institution of the participating centers
* Known allergy to nifedipine or other significant contraindication to nifedipine
* Inability or unwillingness to provide informed consent
DNA Analysis of Tissue Samples From Patients With Head and Neck Cancer

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at DNA in tissue samples from patients with head and neck cancer.

OBJECTIVES:

* Assess common genetic mutations in tumor and germline DNA samples from patients with head and neck squamous cell carcinoma (HNSCC).
* Search for viral DNAs and relate this information to demographics, tumor characteristics, and patient prognosis.
* Search for novel viral sequences and cancer-associated gene mutations in young nonsmoking HNSCC patients and in other distinct head and neck cancers.
* Determine tumor suppressor gene mutations in HNSCC patients and relate this information to gene expression data.
* Validate gene expression information using independent techniques such as real-time PCR on expressed sequences and immunohistochemistry.

OUTLINE: Genetic mutation analysis and gene expression studies are performed on tissue samples from patients with head and neck squamous cell carcinoma. Techniques used include real time-PCR and immunohistochemistry.

Eligibility Criteria:
Inclusion Criteria:

* Patient with head and neck squamous cell carcinoma (HNSCC) enrolled in the Head and Neck Tissue Repository

  * Sufficient biological material collected to perform study tests
* Historical material available from excess tissues at the Vanderbilt Pathology Department

Exclusion Criteria:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Gene Polymorphism Associated With Macroangiopathy in Type 2 Diabetes Patients

To explore the possible implications of HLA-DRB1\*04 alleles in patients with type 2 DM and macroangiopathy

Previous studies examining the molecular etiology of diabetes mellitus in China and abroad have mainly focused on the relationship between HLA and type 1 diabetes mellitus (DM) (1-3). Due to the complexity of type 2 DM heredity, few researchers have studied the correlation between type 2 DM and HLA. In recent years, it has been suggested that the development of coronary heart disease (CHD) in diabetic individuals is not merely a complication of diabetic macroangiopathy. CHD and diabetic macroangiopathy share some genetic associations. Previous studies have demonstrated that certain HLA\*DRB1\*04 subtypes are associated with an increased risk of cardiovascular disease.

Experimental methods: For genomic DNA extraction, 3-5ml venous blood samples were collected from all patients. Coagulation was prevented using EDTA.

The procedure for PCR amplification was as follows: denaturing for 100s at 96°C, annealing for 60s at 63°C, 1 cycle; denaturing for 10s at 96°C, annealing for 60s at 63°C, 9 cycles; denaturing for 10 s at 96°C, annealing for 30 s at 59°C; extending for 30 s at 72°C, 20 cycles; maintaining at 4°C. Analyzing PCR products stained by Ethidium Bromide on 2.5% agarose gel electrophoresis. Bands were observed using an ultraviolet light and a biological imaging system.

Statistical method: The degree of agreement with Hardy-Weinberg equilibrium was determined using the χ2 test. A t-test was employed for comparison of CRP levels (M ± s) and a χ2 test was performed to compare allelic frequencies. The relative risk rate (RR) was calculated as (Number of patients with the gene×Number of people in control group without the gene) divided by (Number of people in control group with the gene×Number of the patients without the gene). PC was calculated using Fisher's method if χ2 \> 3.84.

Eligibility Criteria:
Inclusion Criteria:

* clinical CHD (such as angina pectoris, myocardial infarction) diagnosed by dynamic electrocardiogram and ultrasonic cardiogram;
* coronary atherosclerosis confirmed by coronary angiographic examination;
* cerebral infarction diagnosed by cerebral CT;
* common carotid artery intimal-media thickness (IMT) ≥1.2 mm measured by Doppler ultrasonic examination;
* extensive irregular stenosis of a lower extremity artery (diameter \< 3mm) or segmentally obstructed.

Exclusion Criteria:

* age \< 20 years
* age \> 60 years
Pilot Testing the Check Up

We propose to pilot test an adapted version of the Teen Marijuana Check Up (TMCU) for persistent cannabis users with first episode psychosis (FEP) in Coordinated Specialty Care (CSC). The adapted version of the TMCU will include tailoring to risks of persistent cannabis use in FEP, providing education on lower risk cannabis use, and adding a session to address collaborative planning to maintain CSC engagement and antipsychotic adherence and to reduce harm associated with cannabis use.

We propose to adapt the Teen Marijuana Check Up for persistent cannabis users with FEP in CSC. Dr. Walker, the developer of the TMCU, will be a consultant. Adaptations will include tailoring content of assessment and feedback to risks of persistent cannabis use in FEP, providing education on lower risk cannabis use, and adding a session to address collaborative planning to maintain CSC engagement and antipsychotic adherence and to reduce harm associated with cannabis use. We will also develop guidelines for integrating continued collaborative, harm-reduction focused discussion of cannabis use into CSC, consider adding booster or check-in sessions, and specify how family members can be brought into the check-up process. To inform these adaptations, we will collect quantitative data from cannabis-using FEP patients (n of 40) and conduct qualitative interviews with cannabis-using patients, family members, and CSC clinicians (15 of each) about their perspectives on cannabis use and CSC participation (Aim 1). We will use these data as part of an iterative process to specify the adapted intervention that will integrate information gathered from team discussion and focus groups with FEP patients and family members and vetting of intervention components by key stakeholders (Aim 2). Finally, we will conduct a pilot of the adapted intervention (n of 40 cannabis-using FEP patients compared to matched controls) to examine feasibility, acceptability, fidelity, and preliminary impact on intervention targets and outcomes (Aim 3). If results are promising, the intervention can be tested in a large RCT across the EPINET.

Eligibility Criteria:
Inclusion Criteria:

1. Age 13-35
2. DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, delusional disorder, other specified schizophrenia spectrum and other psychotic disorder, and unspecified schizophrenia spectrum and other psychotic disorder
3. Duration of illness: ≤ 2 years
4. Enrolled at a Coordinated Specialty Care program
5. Report current use of cannabis
6. Ability and willingness to provide informed consent to participate

Exclusion Criteria:

1. Individuals who do not meet all inclusion criteria are excluded.
Normal Saline Versus Heparin Intermittent Flushing for the Prevention of Occlusion in Port-a-Cath

Purpose:

An evidence implementation of a randomized controlled trial for whether there is the difference in intermittent flushing 0.9% normal saline and heparin? Design: a single-blind randomized controlled trial

Method:

This study is based on the 5A (Ask, Acquire, Appraise, Apply, Audit) of evidence health care step, and design randomized controlled trial for evidence implementation.

We will include inpatients over 20 years-old adults in New Taipei City TuCheng Hospital, Taiwan, who need administration medicine by port-a-catcher. The sample size is 192 according to G-power software. Random allocation software has using for block randomization, would assign to group A: flushing with 0.9% normal saline 10ml, group B: flushing with 0.9% normal saline 20ml, and group C: flushing with heparin 100 USP/ml. SPSS 20.0 software for statistical analysis, mean or standard deviation, one- way ANOVA would use.


Eligibility Criteria:
Inclusion Criteria:

Non-pediatric inpatients over 20 years of age with PAC placed for any disease and who need medication during hospitalization.

Exclusion Criteria:

History of PAC obstruction, continuous high volume drip via PAC, taking anticoagulant or antiplatelet agents, abnormal blood coagulation, pregnancy or contraceptive use, specified flushing solution by case