cyrilzakka/clinical-trials huggingface dataset:
The Optimal Dose of Mannitol for Intraoperative Brain Relaxation During the Operation of Aneurysmal Subarachnoid Hemorrhage

Aneurysmal subarachnoid hemorrhage (aSAH) tended to lead to a sudden increase in intracerebral pressure (ICP), which can cause decreased cerebral perfusion and transient global cerebral ischemia. Early clipping and coiling of aneurysms and surgical evacuation of intracerebral hematoma were recommended for aSAH patients. However, the high ICP made it difficult to separate the subarachnoid space during the operation. Effective reduction of ICP was the key to the succession of the operation. But there is a lack of consensus on the management of raised ICP in aSAH. Mannitol is widely used to reduce ICP in patients with cerebral edema. The potential mechanism including decreasing the viscosity of the blood improving regional cerebral microvascular flow and oxygenation and increasing intravascular volume due to increased plasma osmolality. The magnitude of the pressure reduction was correlated with the intact intracranial automatic adjustment function. However, the hypochloremic metabolic alkalosis, hypernatremia, hypokalemia and renal failure associated with mannitol overdose must be considered and the effective dose and the duration of its administration were still unknown. The aims of this study were to determine the most appropriate mannitol dose to provide adequate brain relaxation in aSAH patients with the fewest adverse effects.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute subarachnoid hemorrhage
* Patients who underwent frontal-temporal craniotomy pterional approach aneurysm clipping surgery under general anesthesia.
* Patients operated by the same surgeon (Dr. Chen Xiaolin).

Exclusion Criteria:

* Patients who do not agree to the surgery.
* Patients who have congestive heart failure and kidney insufficiency.
* Patients who have pre-operative electrolyte imbalance.
* Patients who did not take the frontotemporal pterygoid approach.
* Patients with contraindications to mannitol due to low blood pressure.
* Patients who have had more than 3 days from bleeding to surgery.
* Patients with intracranial hematoma.
* Patients with Hunt-Hess grades 4-5.
* Patients who received intravenous mannitol within 6 hours before surgery.
* Patients who underwent ventricle puncture and drainage surgery before surgery.
Treatment of Patients With Advanced Rectum Cancer With Capecitabine and Oxaliplatin Before, Under and After Radiation and With Adding Cetuximab to K-RAS Wild-type Patients

response rate to adding cetuximab, oxaliplatin and capecitabine to radiation for advanced rectum cancer

Dynamic MRI will be used to monitor the effect of the treatment and will be compared to pathologic results.

Eligibility Criteria:
Inclusion Criteria:

* advanced rectum cancer

Exclusion Criteria:

* prior radiation
Impact of Intravenous Methylprednisolone Treatment on Blood Pressure

Hypertension is common side effect of Cushing Syndrome (CS): in patients with endogenous CS and those treated with glucocorticosteroids (GCs). The impact of the intravenous GCs therapy on blood pressure (BP) remains unclear. According to the European Group On Graves' Orbitopathy (EUGOGO), patients with active, severely symptomatic and sight-threatening Graves' orbitopathy (GO) should be treated with high dose intravenous methylprednisolone (IVMP) pulses. There are, however, reports of fatal side effects that may be associated with this therapy (e.g.: pulmonary embolism, myocardial infarction, severe cerebrovascular events, acute liver damage and sudden death). For this reason, the cumulative dose of IVMP should not exceed 8 g within each treatment course, and pulses should not be given on consecutive or alternate days, except for the case of dysthyroid optic neuropathy. A consensus on the monitoring of patients during and after IVMP pulse administration is not yet established. What is more, there is lack of paper regarding pattern of blood pressure at various time points during and after ivGCs administration. Thus, the investigators decided to evaluate acute changes of N-terminal pro-brain natriuretic peptide (NT-proBNP) as a marker of hemodynamic stress and to monitor BP before, during and after IVMP pulse administration. All of patients were treated routinely according to EUGOGO recommendations with standard doses of methylprednisolone with standard recommended schedule. Inclusion criterion for the therapy was according to EUGOGO guidelines active, moderate-to-severe and active GO (12 pulses of IVMP 6x0.5g followed by 6x0.25g every week).

Laboratory tests such as NT-proBNP, troponin I (TnI) and high - sensitivity C - reactive protein (hs-CRP) were performed before, 24 h and 48 h after IVMP during the following pulses: 1st, 6th and 12th. Patients underwent echocardiographic examination before 1st and after 12th pulse. 48-hours ambulatory blood pressure monitoring (ABPM) (for 24 hours before and 24 hours after IVMP) was done during the following pulses: 1st, 6th and 12th.

Eligibility Criteria:
Inclusion Criteria:

* active, moderate-to-severe GO according to EUGOGO classification
* euthyroidism
* completion of at least first six IVMP pulses.

Exclusion Criteria:

* cardiovascular morbidity (such as chronic heart failure and/or coronary heart disease)
* uncontrolled hypertension (defined as systolic blood pressure (SBP) more than 140 mmHg and/or diastolic blood pressure (DBP) more than 90 mmHg)
* contraindications to IVMP therapy
* previous GCs treatment in the last 6 months.
Non-pharmacological Methods in Pain Managment During Heel Stick in Preterm Infants

Aims and objectives: This study was performed to examine the effects of Non-nutritive sucking, breast milk odor, and Facilitated tucking on preterm infant pain before, during, and after heel-stick procedures.

Design: A randomized clinical trial in a single center.

Methods:

The study was conducted on 144 premature infants with a gestational age of 31 to 36 weeks and 6 days hospitalized in the neonatal intensive care unit of Shahid Sayad Shirazi Hospital in Iran. Neonates were randomly assigned to four groups: 36 babies were included in the Non-nutritive sucking(1st Group), 36 in breast milk odor (2nd Group), 36 in Facilitated tucking (3rd Group), and 36 in the control group (4th Group). Pain score, heart rate, oxygen saturation, and respiratory rate of the babies in all groups before, during, and after the procedure were evaluated by two nurses independently.

Aim: Due to the necessity of various painful procedures and their side effects on infants, pharmacological and non-pharmacological methods are adopted to reduce the pain. Since pharmacological methods can be associated with several side effects, it is better to use non-pharmacological methods for pain control in newborns. Therefore, the purposes of this study were to compare the effects of three different methods (including Non-nutritive sucking, breast milk odor, and Facilitated tucking) on preterm infant pain before, during, and after heel-stick procedures.

Method: The study was conducted on 144 premature infants with a gestational age of 31 to 36 weeks and 6 days hospitalized in the neonatal intensive care unit of Shahid Sayad Shirazi Hospital, Iran. Initially, neonates are divided into two groups according to gestational age (including neonates between 31-33 weeks and 34-36 weeks) to moderate the confounding effect of the age, and then the allocation of neonates to four groups was performed.

Using the stratification block randomization method, 36 babies were included in the Non-nutritive sucking(1st Group), 36 in breast milk odor (2nd Group), 36 in Facilitated tucking (3rd Group), and 36 in the control group (4th Group). Two researchers viewed the recorded videos independently and evaluate the heart rate, oxygen saturation, respiratory rate, and neonatal pain at 1st,2nd,3rd minute before the procedure, during, and at 1st,2nd,3rd minutes after the procedure according to the Premature Infant Pain Profile (PIPP).

Eligibility Criteria:
Inclusion Criteria:

1. Week of gestation is between 31 and 36 weeks
2. Not being exposed to a painful procedure at least 1 hour before the interventions
3. At least 1 hour has passed since feeding
4. Not taking analgesics and/or sedatives in the last 4 hours
5. Body weight of 1000 grams or more
6. Having mother's milk
7. Not exceeding the 10th day of postnatal age

Exclusion Criteria:

1. Having ventilator support
2. Having a congenital anomaly
3. Using analgesic / narcotic analgesic drugs
4. Continuous sedative treatment
5. Having a congenital malformation that may cause asphyxia and affect respiration
6. Having intracranial bleeding
Pharmacists Intervention to Improve Hypertension Management in Primary Care

Arterial hypertension is the single largest contributor to mortality world-wide, and only 30-50% of diagnosed and treated patients achieve their blood pressure goal. The APOTHECARE trial is designed to identify treated patients with uncontrolled hypertension in community pharmacies in order to improve blood pressure control through intensification of antihypertensive therapy.

Patients with medically treated arterial hypertension, who attend a pharmacy in order to obtain their antihypertensive medication are invited to participate in the trial.

The main inclusion criteria is uncontrolled hypertension, as determined by an automated office blood pressure measurement at a threshold of 135/85 mmHg.

Main exclusion criteria include a first-ever prescription of an antihypertensive agent, resistant hypertension, systolic blood pressure ≥ 180 mmHg and dialysis.

Randomization occurs on the level of pharmacies (cluster randomization).

Patients in the interventional arm are immediately referred to their treating physician for up-titration of antihypertensive therapy. Re-examination of automated automated office blood-pressure occurs in the respective pharmacy, and patients are referred to their treating physician again if required. These measures are accompanied by a structured and educational blood pressure record card.

Patients in the observational arm undergo periodic automated office blood pressure measurements and are referred to their treating physician at the end of the trial in case of persistently uncontrolled blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age \> 18 years
* Medically pre-treated arterial hypertension
* Automated office blood pressure ≥ 135 mmHg systolic or ≥ 85 mmHg diastolic

Exclusion Criteria:

* First ever prescription of antihypertensive medication
* First prescription of a new antihypertensive substance or dose adjustment
* Prior therapy with 4 or more different antihypertensive substances
* Systolic blood pressure ≥ 180 mmHg
* Dialysis
* Adherence to the study protocol not to be anticipated
* Inclusion into the study at another study site
Study in Healthy Volunteers to Investigate the Safety, Tolerability and Pharmacokinetics of VM-1500

A randomized single dose, drug-drug interaction study in healthy volunteers for VM - 1500 given alone or in combination with Raltegravir or Darunavir in a 3 arm approach. The parallel design is used due to the long half life for VM-1500.

This drug-drug interaction study will not be done as a cross-over study due to the extreme long half life of the drug. The 24 healthy subjects participating will be randomized to VM-1500 alone or VM-1500 in combination with Raltegravir or Darunavir in parallel arms.

For the cohort taking VM-1500 40 mg only just 4 subject will be enrolled as 6 subjects have been already on the same regimen in the trial before. Based on the parallel design it seems appropriate not to expose more healthy subjects than necessary. This means the available data of 6 subjects dosed with 40 mg VM-1500 alone will be matched.

Three groups of healthy subjects will be randomized to VM-1500 alone or VM-1500 in combination with Raltegravir or Darunavir (4:10:10). The healthy subjects will stay at the unit and receive 40 mg VM-1500 alone or VM1500 in combination with Raltegravir or Darunavir one time and PK blood samples at several time points will be collected. PK (trough level) blood samples will also be collected at visits on Days 2, 4,7, 14, 21, and on Day 36.

Eligibility Criteria:
Inclusion Criteria:

1. Male subjects age between 18-45 years
2. Has been determined healthy by physical examination, assessment of drug abuse, medical history and vital signs
3. Has normal or acceptable results for the following screening tests: complete blood count (CBC), blood urea nitrogen (BUN), serum creatinine (Cr), fasting blood sugar (FBS), total bilirubin, aspartate aminotransferase (AST or SGOT), alanine aminotransferase (ALT or SGPT), alkaline phosphatase (ALP) and urinalysis.
4. Negative result for hepatitis A, hepatitis B, hepatitis C and HIV antibodies
5. Willing to participate and signed the informed consent form

Exclusion Criteria:

1. Hepatic or kidney disorders or any other disease or disorder which may in the opinion of the Investigator interfere with the results of the study or threaten the health of volunteers;
2. Drug intake (including herbal drugs) during the last month;
3. Active alcohol and/or drug abuse that, in the opinion of the site investigator, would interfere with adherence to study requirements;
4. Volunteers have taken any investigational drug at least 3 month prior to the start of the study;
5. Inability to understand the Protocol or follow its instructions.
Brain Stimulation and Cognitive Training - Efficacy

People with serious mental illness often experience difficulties with thinking skills like memory. These difficulties can make it harder to perform day-to-day activities. The purpose of this study is to test whether combining a type of non-invasive brain stimulation with computerized cognitive exercises is helpful in improving a specific type of memory skill in people who have mental health conditions.

The study is a randomized clinical trial, meaning that participants will be randomly assigned to receive either 'active' or 'inactive' brain stimulation. All participants will complete computerized cognitive exercises, also known as cognitive training.

Overall, participants will be in the study for 6-8 weeks. The study involves 10 visits to the clinic over 2-4 weeks for cognitive training and either active or inactive brain stimulation. Participants will also complete paper-and-pencil assessments at the beginning and end of treatment, and one month after treatment ends.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bipolar disorder I or II, schizoaffective disorder, or schizophrenia
* Willingness to participate in study procedures

Exclusion Criteria:

* History of neurological illness or injury (e.g., stroke)
* History of loss of consciousness
* Diagnosed intellectual disability
* Current substance use disorder
* Current mania or moderate depression or severe psychosis
* Current serious suicidal ideation/behavior
* Pregnant or trying to become pregnant, or currently lactating
Clitoral Reconstruction (CR) in FGM/C Patients

Surgical interventions to reconstruct the vulva together with psychosexual care have been proposed as a multidisciplinary care concept for women who have undergone female genital mutilation/cutting (FGM/C).

This cross-sectional study is to assess the experiences of multidisciplinary care of women who request CR at Geneva University Hospital (HUG) in order to analyze the expectations and motivations for clitoral reconstruction, to study the reasons for deciding against or in favor of CR and to study the outcome of the care received (CR+ psychosexual care versus psychosexual care alone) in sexual response, eventual dyspareunia, genital self-image and overall satisfaction through questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent of the present study
* French and / or English speaking

Exclusion Criteria:

* Insufficient knowledge of project language (French/English)
* No informed consent
* Inability to sign consent
Study of Web-based Decision Aids for Increasing Breast Cancer Chemoprevention in the Primary Care Setting

The purpose of this randomized controlled trial (RCT) is to evaluate a decision support website (RealRisks) designed to inform patients about breast cancer prevention options. It is coupled with a physician-centered (BNAV) decision support website as part of clinical workflow in the primary care setting. The investigators hypothesize that improving accuracy of breast cancer risk perception and understanding of the risks and benefits of breast cancer risk lowering drugs, also known as chemoprevention, will increase the uptake of chemoprevention in the primary care setting.

Breast cancer is the most common malignancy among women in the U.S. and the primary prevention of this disease is a major public health issue. The U.S. Preventive Services Task Force and other professional organizations recommend that clinicians discuss chemoprevention with high-risk women. Breast cancer chemoprevention with anti-estrogens, such as tamoxifen, raloxifene, exemestane, and anastrozole, is under-utilized, despite several randomized controlled trials demonstrating a 40-65% decrease in breast cancer incidence among high-risk women. Compounding this underutilization is the fact that a large proportion of women may be unaware of their high-risk status due to the investigators' inability to adequately screen them in the primary care setting. Further research is needed to determine how knowledge about breast cancer, actual/perceived risk, and risks/benefits of chemoprevention are best communicated to women in order to promote breast cancer prevention strategies.

The investigators hypothesize that combining a patient-centered decision aid with a physician-centered decision support tool integrated into clinic workflow will improve accuracy of breast cancer risk perception, facilitate referrals for specialized risk counseling, and increase chemoprevention uptake. We anticipate that the BNAV tool will facilitate referrals to the breast clinic by primary care providers (PCPs) and that the RealRisks decision aid will prime high-risk women to seek these referrals. The primary endpoint is uptake of a selective estrogen receptor modulator (SERM) or Aromatase inhibitor (AI) for breast cancer chemoprevention at 6 months (after the next primary care appointment) in the active arm compared to usual care.

Eligibility Criteria:
Inclusion Criteria:

* 5-year breast cancer risk ≥ to 1.67% or lifetime risk ≥ to 20% according to the Gail risk model; or a 5-year breast cancer risk ≥ 1.67% according to the Breast Cancer Surveillance Consortium (BCSC) model
* The participant understands and is willing to provide informed consent in English or Spanish
* Has a primary care provider at Columbia University Medical Center (CUMC) / New York-Presbyterian Hospital

Exclusion Criteria:

* Prior use of a selective estrogen receptor modulator (SERM) or aromatase inhibitor (AI) for chemoprevention
* Prior history of breast cancer
A Research Platform to Screen Healthcare Workers- Coordinated Approach to Pandemic Trials of COVID-19

Recent studies have shown that some individuals may be asymptomatic but continue to shed the COVID-19 virus. These individuals may represent a population that can unknowingly transmit the virus. Healthcare workers (HCW) may acquire COVID-19 from the community or from possibly infected patients. It is important to gather data with respect to this to further understand the prevalence of asymptomatic carriage in individuals who work in research facilities, offices and clinical areas of hospitals and research facilities/institutes since this has important implications for infection control, as well as staff and patient safety. The purpose of this study is to test whether a proportion of these individuals may be asymptomatic shedders of the COVID-19 virus.

Healthcare workers of participating institutions who agree to be participants will:

* Fill out some information about participants into a database portal system. Participants will have the ability to check their COVID-19 test results via the portal.
* Have nasopharyngeal (NP) swabs done for COVID-19 testing. This can be done about once a week for up to 8 weeks (about 1-8 swabs total).
* Provide optional blood samples to look for COVID-19 specific antibodies and/or proteins at the time of enrollment and after 8 weeks.
* Fill out questionnaires about participant exposures and travel history, occupation category, any symptoms in the past 21 days, whether they have provided any face-to-face care of a known COVID-19 positive patients in past 14 days or if participants have any children at home who are less than 12 years of age.
* Fill out an optional questionnaire about their mental health
* Be contacted by telephone if participants are tested positive, to determine whether participants have symptoms of COVID-19, and for the results of any follow-up COVID-19 testing that may have been done.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who work within a food production, healthcare, research or clinical organization.
* Asymptomatic as per daily screening.
* No contraindication to performing a NP swab.

Exclusion Criteria:

* Any individual with fever, respiratory or flu-like symptoms will not be eligible. Symptom positive individuals who were not picked up at entry screening will be referred to their Occupational Health. Specific symptoms include:

  * Fever, chills or headache
  * New or worsening cough
  * Shortness of breath, difficulty breathing, sore throat or difficulty swallowing
  * Runny nose or stuffy nose without another cause (e.g. allergies)
  * Nausea/vomiting, diarrhea, stomach pain
  * Decrease/loss of taste or smell
  * Unexplained fatigue, malaise, muscle aches
  * Eye pain or pink eye In addition to those symptoms listed above, individuals should also be screened for symptoms as per their institutional requirements.
* Enrolled in a COVID-related interventional study (eg. Behavioural or drug study).