cyrilzakka/clinical-trials huggingface dataset:
Modeling the Effects of Chronic Marijuana Use on Neuroinflammation and HIV-related Neuronal Injury

This study applies a hypothesis-driven approach to examine the effects of chronic marijuana use on HIV-associated inflammation and its subsequent impacts on central nervous system function, with the goal of identifying the mechanisms through which cannabinoids modulate neurological disorders and other comorbidities in persons with HIV.


Eligibility Criteria:
Inclusion Criteria:

* verified HIV status
* Current marijuana use (MJ+ groups only)
* No current marijuana use (MJ- groups only)
* current engagement in HIV care (HIV+ participants only)
* receipt of cART as first-line of treatment (HIV+ participants only)
* stable cART regimen (HIV+ participants only)
* undetectable HIV RNA viral load for \>1 year (HIV+ participants only)

Exclusion Criteria:

* Lifetime abuse for any illicit drug other than marijuana
* \<9th grade education; illiteracy or lack of fluency in English
* history of moderate or severe head trauma
* unstable or serious neurological disorders
* severe mental illness
* systemic autoimmune diseases
* immunotherapy
* MRI contraindications
Preadmission Skin Wipe Use for Surgical Site Infection Prophylaxis in Adult Orthopaedic Surgery Patients

Intervention: This study will involve three different study arms with different interventions prior to surgery: (1) shower only, (2) shower plus Theraworx wipes, (3) shower plus chlorhexidine wipes

Study Design: Single center RCT

Sample Size: 500 patients, aged 18+

Objectives: Primary Objectives:

1. Monitor for safety and adverse effects.
2. Evaluate for differences in peri-operative skin cultures between treatment groups;
3. Compare surgical site infection rates between groups.

Secondary Objectives:

1. Assess for patient compliance for each different treatment arms.
2. Measure patient satisfaction.
3. Measure nurse satisfaction.
4. Visual assessment of wound healing

Expected Results: We expect no statistically significant difference in peri-operative cultures or surgical site infection rates between groups.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient between ages 18-64
* Scheduled and deemed healthy enough to undergo orthopaedic surgery
* Willing and able to comply with protocol

Exclusion Criteria:

* Clinical signs of infection
* Contraindication to CHG or Theraworx
* Previous allergic reaction to CHG or Theraworx
* Surgeon's Discretion
Food and Alcohol Behavior Study: Meaningful Enhancement

This study will determine how folate supplementation affects both serum and red blood cell folate status in females ages 18 -24 years old. Additionally, this study will determine the effect of folate supplementation on mood, cognition, and sleep patterns. This study will fill a crucial gap in understanding how folate status affects a variety of health behaviors in order to better inform public health practice and prevention.

Preliminary studies conducted by the investigator's team indicate that 95.7% of previous participants (all alcohol consuming, ages 14-24), were below the threshold for red blood cell (RBC) folate status for women of childbearing potential. Understanding how the interaction of behaviors (alcohol use, nutrient supplementation, diet) contribute to sub-optimal folate status is critical to developing and expanding upon evidence-based FASD prevention programs. Notably, how nutrient supplementation might improve overall folate status in a group with poor folate status and other behaviors that confound the absorption of folate. Because the participants do not view themselves as being at risk for unwanted pregnancy, their motivation to take a supplement for a future pregnancy is very low. This team seeks to collect data on how folate supplementation might improve individually measured outcomes, like cognition and mood, so that interventions might be developed focusing on these individual outcomes.

After becoming aware of the study, prospective participants will undergo a screening questionnaire for inclusion/exclusion criteria. Once the participant meets the inclusion criteria, the study will be fully explained and written informed consent will be handed out. Participants will be randomized in a single-blind manner (participant) in a 1:1 ratio to the Methyl Folate supplement (1,000 mcg, once daily) or placebo (once daily).

Eligibility Criteria:
Inclusion Criteria:

* Females restricted to those living in the United States
* Not currently using hormonal birth control
* Must experience menses
* Must begin the study exactly one week after the start of their menstrual cycle
* Folate consumption must be less than or equal to 250 micrograms of dietary folate equivalents (DFEs)

Exclusion Criteria:

* Current use of a folate supplement
Rouviere Sulcus Plane and Hepatic Hilum Plane, Which is Better as a Landmark in Laparoscopic Bile Duct Surgerys

RS and the RS plane are important anatomical markers in laparoscopic cholecystectomy. However, there are many variations in the shape and orientation of the RS, and the RS plane is an imaginary plane, which can be misjudged by different surgeons. The purpose of this study is to introduce a more intuitive anatomical marker and anatomical plane, hilum plane, and discuss the application value of hilum plane in laparoscopic biliary surgery by comparing it with RS and RS plane.

Hepatic hilum plane is the hepatoduodenal serosa plane that extends from the base of the liver IVa segment down to the first segment of the gallbladder triangle.

During the operation, first pulling the gallbladder to the head side, using the separating forceps to slide down horizontally from the hilum (the basement of hepatic segment Ⅳ), and along the serous of hepatoduodenal ligament, that is so called "hilum plane".

It forms a "neck-shoulder" structure when the hilar plane meets the tent-like hepatobiliary triangle. the serosa of hepatobiliary triangle was dissected on the neck area and ventral side of hilar plane, and the serosa of posterior triangle of the gallbladder was also cutted on the same extension line . In this process, the type and orientation of RS, the relationship between the plane of the RS sulcus and the plane of the hilar plane were also recorded and compared with hilum plane.

Eligibility Criteria:
Inclusion Criteria:

Benign disease of the gallbladder requires surgery

Exclusion Criteria:

Patients with severe cirrhosis or had a history of partial hepatectomy were excluded from the statistics .

patients with unexpected gallbladder carcinoma.
MPP Narrow QRS:Pilot Study on Multipoint Pacing in Patients With QRS Beetwen 100 and 130 Msec

The purpose of this study is to assess the impact of the Multi Point Pacing (MPP) feature in the treatment of patients with QRS beetwen 100 and 130 msec in patients candidate to ICD implant.


Eligibility Criteria:
Inclusion Criteria:

* Patients with EF \< 35% on OPT at least 3 months and candidate to ICD
* QRS duration: 100-130 ms
* Patients willing and able to comply with study requirements
* Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form
* Successful quadripolar LV lead implant (only for Treatment Group)

Exclusion Criteria:

* Myocardial Infarction, unstable angina within 40 days prior the enrollment
* Patients with no left ventricular contractile reserve after low dose dobutamine stress echocardiography test
* Recent cardiac revascularization (PTCA, Stent or CABG) in the 4 weeks prior to enrollment or planned for the 3 months following
* Cerebrovascular Accident (CVA) or Transient Ischemic Attack (TIA) in the 3 months prior the enrollment
* Primary valvular disease
* Unable to comply with the follow up schedule
* Less than 18 years of age
* Pregnant or are planning to become pregnant during the duration of the investigation
* Classification of Status 1 for cardiac transplantation or consideration for transplantation over the next 12 months
* Undergone a cardiac transplantation
* Life expectancy \< 12 months
* Patients with permanent Atrial fibrillation
* Patients with Nyha 1
Is the Concentration of Anti-Muellerian Hormon (AMH) Depending on the Menstrual Cycle?

The developement of a new, stable measurement of the Antimuellerian Hormon (AMH) together with Roche Diagnostics International (Rotkreuz, CH) shall enable an automized and timely measurement of AMH values in blood samples.

An important requirement for the use of the new measurement to determine the AMH concentration is the stability of the AMH level over the menstrual cycle. So far the unbiased AMH concentration is the most important argument to manage this parameter.

There are several studies, which give different professional opinions of the AMH concentration depending on the phase of the menstrual cycle. Some authors came to the conclusion that the AMH concentration over the menstrual cycle is constant, others described significant fluctuations. It is unclear, if the described fluctuation is relevant for the interpretation of the ovarian reserve. Recently it could be shown, that intraindividual fluctuations of joung women during the menstrual cycle is stronger, which means that the measurement of AMH in this age is less secure.

The primary goal of the study is to evaluate, if the new AMH measurement with the ElecSys method delivers stable values over the menstrual cycle.

The secondary goal of the study is to determine whether there are any fluctuations in the number of antral follicles as given by 3D ultrasound.

For this reason we are recruiting a group of 50 women within two categories of age to measure eventually changes in AMH- concentration during their menstrual cycle.

Eligibility Criteria:
Inclusion Criteria:

* Regular natural menstrual cycle between 24 and 32 days
* Body Mass Index (BMI) between 19 and 26 kg/m2
* Negative serum titer for HIV, Hepatitis B and Hepatitis C
* Non-smoker
* Willingness to visit the clinic every second day of two non-consecutive menstrual cycles.

Exclusion Criteria:

* Intake of hormonal medication like contraceptives
* Pregnancy/breast feeding
* Known infertility
* Known former or actual hormonal disorder
* Polycystic ovarial syndrom (PCOS)
* Participation on another clinical trial during the last 3 months.
POstoperative Negative-pressure Incision Therapy Following LIver TRANSplant:a Randomized Controlled Trial

This study is to evaluate whether the prophylactic use of a negativa pressure therapy device (PICOⓇ) on the closed wound of the liver transplant, reduces the postoperative complications of surgical wounds, compared to the use of dressings conventional postoperative

Postoperative complications of surgical wounds are frequent after surgical procedures, even more in the context of liver transplantation given the necessary immunosuppression, high surgical time, high hospital stay and intensive care, politransfusions, etc. Negative pressure therapy is well established for the treatment of open wounds, its use having been recently indicated on closed surgical wounds. The evidence to justify this intervention is still limited.

The objective of our clinical trial is to evaluate whether the prophylactic use of a negative pressure therapy device (PICOⓇ) on the closed wound of the liver transplant, reduces the postoperative complications of surgical wounds, compared to the use of dressings conventional postoperative After signing the informed consent of those patients who meet the inclusion criteria, they will be randomized into two groups to install the PICOⓇ device or conventional dressings on the wound. After 7 days, the PICOⓇ device will be removed and both preoperative and postoperative variables will be studied in terms of incidence of surgical site events, stay, etc.

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes aged between 18 and 70 years included in the waiting list for liver transplantation by the committee of the Virgen de la Arrixaca University Hospital.

Exclusion Criteria:

* To have been rejected for liver transplantation by said committee
Treatment as Prevention for Hepatitis C in Iceland

The main aim of this study is to test in the Icelandic population the hypothesis that a nationwide treatment program which offers effective treatment to all known cases of Hepatitis C with the aim of halting HCV (Hepatitis C virus) transmission will lead to a reduction in incidence and disease burden associated with chronic HCV infection.

In Iceland, a nationwide effort is planned where all patients with HCV infection will be offered treatment using direct acting antiviral agents. The aim of the initiative, besides offering cure to patients, is to substantially reduce domestic transmission of HCV and thereby lower the incidence. Ultimately, with these intense efforts the long-term complications of chronic HCV infection could potentially be nearly eliminated. In Iceland, there is mandatory reporting of all new cases of hepatitis C to the State Epidemiologist.

In the study, short term and long term outcomes of this initiative will be investigated. In an initial treatment phase which will last for up to three years, all patients diagnosed with hepatitis C in Iceland will be offered treatment with direct acting antiviral agents. Virological response rate and compliance will be monitored. Long term, the incidence of HCV infection acquired in Iceland will be monitored for up to 15 years, and the incidence rates of cirrhosis and hepatocellular carcinoma due to HCV will be monitored for up to 15 years.

Eligibility Criteria:
Inclusion Criteria:

* HCV positive subjects 18 years and older, living in Iceland and covered by the Icelandic Health Insurance.

Exclusion Criteria:

* Age under 18 years
* Inability to sign informed consent.
Effect of Nature Based Sounds' Intervention on Agitation and Anxiety of Patients Admitted in Intensive Care Units.

Effect of nature based sounds' intervention on Agitation and Anxiety of patients admitted in Intensive Care Units of MMIMS\&R Hospital, Mullana, Ambala

INTRODUCTION: Continue stay in ICU can lead to sleep disturbances and poor stress management that may result in client's inability to adjust with the situations and use of medical support. This experience may lead to increase agitation, anxiety as well as physiological stress of client, decrease comfort level and increase recovery time as well as hospital stay. There has been great emphasis on non-pharmacological methods that decrease anxiety and stress since they are very appropriate and affordable.

OBJECTIVES: The objective of the study was to assess the effect of Nature Based Sounds on Agitation and Anxiety of patients admitted in Intensive Care Units.

METHODOLOGY: A Randomized Controlled Trial with pretest posttest control group design was used. Sixty patients from Surgical Intensive care unit and were selected conveniently and randomly assigned into experimental and control group using lottery method. Data was collected by Agitation Behavior Assessment Scale and Beck Anxiety Inventory.

Eligibility Criteria:
Inclusion Criteria:

1. Willing to participate in the study.
2. In age group of 18 -75 years.

Exclusion Criteria:

1. Patients who were not having agitated behavior, normal anxiety and normal physiologic stress scores.
2. Patients who were taking anti-hypertensive drugs, anti-depressants drugs and sedatives.
3. Who could not response verbally or non-verbally in response to Sample Characteristics Performa and Beck Anxiety Inventory.
4. Patients who were having psychiatric or neurological illness.
TNT to Increase the Clinical Complete Response Rate for Distal LARC

This is a open-label, single-arm study to investigate the safety and efficacy of total neoadjuvant treatment (TNT) in patients with locally advanced resectable rectal cancer.

Standard treatment of rectal cancer is neoadjuvant capecitabine chemotherapy with radiotherapy, followed by total mesorectal excision.

A new concept suggests organ preservation as an alternative to rectal excision in good responders after neoadjuvant radiochemotherapy to decrease surgical morbidity and increase quality of life.

The rational is the fact that 15%-20% of patients have sterilized tumours after chemoradiotherpay for locally advanced rectal cancer. As compared to capecitabine alone, oxaliplatin and more intensified chemotherapy have been shown to increase tumor regression in the neoadjuvant chemoradiation setting. Meanwhile, prolong of time interval from the end of radiotherapy to assessment of tumor response could further increase pathologic complete response rate and complete clinical response rate.

The objective of this trial is to increase the rate of clinical complete response for distal rectal cancer patients by optimizing tumour response. The investigators expect to increase chance of clinical complete response by using total neoadjuvant treatment regimen as compared to conventional chemoradiotherapy alone.

Eligibility Criteria:
Inclusion Criteria:

* Rectal adenocarcinoma
* cT3-4aNany or cTanyN+
* Location ≤5 cm from the anal verge
* No distant metastasis
* No gastrointestinal obstruction or relieved obstruction
* No previous surgery of the rectum, no previous chemotherapy, no previous pelvic radiation, no previous biotherapy
* ECOG 0-1
* Expected survival length ≥ 2 years
* Age 18-70
* Sufficient bone marrow, kidney and liver function
* Effective contraception during the study
* Patient and doctor have signed informed consent

Exclusion Criteria:

* Distant metastasis
* Chronic intestinal inflammation and/or bowel obstruction
* Contra indication for chemotherapy and/or radiotherapy
* Previous pelvic radiotherapy or chemotherapy
* Severe renal, hepatic insufficiency (serum creatinine\<30ml/min)
* Peripheral neuropathy \> grade 1
* Pregnant or breast-feeding woman
* Certain or suspicious allergy to research drug
* Cachexia, organ dysfunction
* Active severe infection
* Multiple primary cancers
* Epileptic seizures
* Malignant history within 5 years, except cervical carcinoma in situ or cutaneous basal cell carcinoma
* Severe arrhythmia, cardiac dysfunction (NYHA grade III or IV )
* Uncontollable severe hypertesion
* Persons deprived of liberty or under guardianship
* Impossibility for compliance to follow-up
A Mass Balance Study to Investigate the Absorption, Metabolism, and Excretion of [14C]Sulfatinib

This is a single-center, open label and single-dose clinical trail, to explore the body mass balance and identify the major metabolites in Chinese adult male healthy volunteers after a single oral dose of \[14C\]Sulfatinib, to obtain the pharmacokinetic parameters of plasma and observe the safety of healthy volunteers after a single oral dose of \[14C\]Sulfatinib.

In order to determine the optimal time point for sample collection, this study will be divided into two stages: the first stage, two volunteers will be enrolled, the volunteers should stop collecting the corresponding samples by the investigators based on radioactive test results, safety results combined with the actual comprehensive situation. And in the second stage sample collection time for another four volunteers will be determined and adjusted according to the results of the first stage.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of written Informed Consent Form (ICF)
2. Age of 18-50 (inclusive)；
3. Body weight over 50 kg and body mass index (BMI) between 19-26 kg / m2 (inclusive)；

Exclusion Criteria:

1. Laboratory tests (blood tests, blood biochemical tests \[fasting\], coagulation tests, thyroid function tests, urinalysis, fecal occult blood) judged as clinically significant abnormal by investigators；
2. Clinically significant abnormal ECG at screening and before screening；
3. Hepatitis B surface antigen (HBsAg), e antigen (HBeAg) or hepatitis C antibody (HCV Ab) test positive；
4. Human immunodeficiency virus (HIV) antibody positive；
5. Treponema pallidum antibody positive.
Technical Performance of a New Cardiac Technology "IQ-SPECT" Applied to SCINTI-CT Myocardial Imaging With 99mTc-Sestamibi in Coronary Patients

Cardiological examination is one of the major directions in nuclear medicine for detection of myocardial ischemia in patients with suspected coronary artery disease. In Caen, they constitute 20% of the activity of nuclear medicine. It is evaluating a new versatile innovative technology (IQ-SPECT) for performing rapid nuclear cardiological examinations (4 minutes) and quality on a SCINTI-CT camera for correcting the mitigation. This technical solution IQ-SPECT was made available to the nuclear medicine department in August 2011. To date, apart from the work on heart ghosts and one publication in abstract form in 2009, no other study have been published.

The goal of the study is to study the technical performance of the innovative technology IQ-SPECT during a SCINTI-CT imaging in patients suspected of coronary disease .


Eligibility Criteria:
Inclusion Criteria:

* age over 18 years (except major patients under guardianship)
* free and informed consent signed
* written and spoken French
* beneficiaries of the social security system
* coronary insufficiency detection needed for patients with signs or symptoms suggestive of coronary insufficiency; or in symptomatic patients, but with a high risk of coronary heart disease: diabetes and / or with multiple cardiovascular risk factors and / or having a peripheral vascular disease

Exclusion Criteria:

* Patients with a recent history (\<21 days) acute coronary failure (myocardial infarction, unstable angina);
* Patients with an irregular heartbeat, because of the impossibility of achieving a good quality ECG synchronization (atrial fibrillation, ventricular extra-systole or supraventricular over 25% of cardiac cycles);
* Patients with a pacemaker with a permanent electro-drive at rest;
* Patients with non-ischemic heart disease: primitive dilated cardiomyopathy, severe hypertrophic cardiomyopathy, severe valvular cardiomyopathy (aortic stenosis, aortic or mitral leakage grade\> 2), congenital heart disease;
* Patients with severe extra-cardiac disease may interfere with treatment decisions (cancer, severe hepatic or renal impairment);
* Major patients under guardianship;
* Pregnant or lactating women;
* Women in age and condition of childbearing;
* Patients unable to understand the purpose of the study.

Cons-indications to physical stress test:

* Uncontrolled heart failure,
* Pulmonary embolism, phlebitis evolution,
* Myocarditis, pericarditis, endocarditis evolving
* Physical disability,
* Thrombus
* Asthma
* contra-indication for exercise testing as dipyridamole:
* Severe Asthma