cyrilzakka/clinical-trials huggingface dataset:
Clinical Calibration & Validation of a Next-Generation Blood Pressure Monitor for Patient Management

The objective of the Cloud DX Pulsewave Health Monitor study is to prospectively calibrate and validate a novel, non-invasive wrist cuff blood pressure device against the gold standard for hemodynamic monitoring (intra-arterial pressure) in voluntarily consented patient participants who are scheduled for an elective cardiac catheterization procedure for clinically valid reasons.

The Cloud DX Pulsewave Health Monitor is a non-invasive wrist cuff blood pressure device that is licensed by Health Canada with Food and Drug Administration approval. Systolic and diastolic pressures are measured via the arterial pulse waveform of the left radial artery. Initially, the blood pressure algorithm was created and calibrated using the auscultatory method. The purpose of this study is to calibrate the device to the clinical gold standard of peripheral and central intra-arterial pressures.

The device acquires a pulse signal in real-time, stores signal and measurement data, and displays stored signal and measurement data for interpretation via internet servers where it is accessible by end-users (physicians and/or patients). The system provides secure accounts for both in-patient and out-patient monitoring. Cloud DX's Pulsewave Health Monitor servers are housed in a secure data center. Privacy measures are to SSAE16 SOC-1 Type-II compliance: 1) restricted secure access, 2) dedicated firewall, 3) HTTPS channel communication via website, 4) self-encrypting hard-drives rendered useless if removed from the server.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 19 years of age
* Patients recommended by their cardiologist for a first-time, elective cardiac catheterization procedure
* Wrist circumference between 13.5cm - 23cm (5.3 - 9.1in.)
* Bilateral arm blood pressure equality (systolic within ±10mmHg; diastolic within ±5mmHg) on 2 separate readings (Nurse Associate \& TRA)
* Willing to volunteer to participate and to sign the study specific informed consent form

Exclusion Criteria:

* No history of peripheral vascular disease, no previous percutaneous coronary intervention, nor previous coronary artery bypass graft
* No arrhythmia
* No abdominal aortic aneurysm
* No hand/body tremor
Effect of Synthetic Oxytocin Administered During Labor on Breastfeedings

This study was designed as a retrospective cohort study where patients given synthetic oxytocin during labor induction were considered as the exposed cohort, and patients not given oxytocin formed the non-exposed cohort. Four hundred of the 7465 children born at our maternity during 2006 were randomly selected. Information about breast-feeding was available for 316 of these children. Eventual confounding or adjustment factors were analyzed using stratified and multivariate analysis (logistic regression

Study population consisted of children born in our center (Hospital Materno-Infantil in Malaga) during 2006. Our hospital is a tertiary center of the Spanish national health system where were born 7465 children, representing 41.2% of all babies born in our province, from 7246 deliveries during that year 21. Random sample size was estimated at 400, with a 95% confidence levels and a 20% power, considering an expected RR of 0.82 22, a ratio between exposed and unexposed groups of 1.5, and a 20% loss. The sample selection was done by random sampling with the SPSS random number generator.

Once approval was obtained from the ethics and research committee of the hospital, recruitment and monitoring of selected cases was started during 2011. Data were collected by review of clinical records and interviews with the mothers (particularly to record breast-feeding type and duration). Patients were referred to the hospital for a semi-structured interview in which data were collected for type and duration of feeding. Clinical records were used as information sources for obstetric variables. Both the interviews and the review of medical records were blinded and conducted by the study authors in different days

Eligibility Criteria:
Inclusion Criteria:

* children born in our center (Hospital Materno-Infantil in Malaga) during 2006

Exclusion Criteria:

-
Non Alcoholic Fatty Liver Disease: Nutritional Epidemiology and Lifestyle Medicine

The study is an open-label intervention non pharmacological Cohort Study without control arm in patients with Non Alcoholic Fatty Liver Disease (NAFLD) and in healthy subjects.

The intervention in patients with NAFLD is educational, providing personalized suggestions to improve diet and physical activity; the intervention in healthy subjects is educational, providing general suggestions to improve diet and physical activity.


Eligibility Criteria:
Inclusion Criteria:

* Presence of Fatty Liver at ultrasonography

Exclusion Criteria:

* Pregnancy;
* Breast Feeding
* Cirrhosis or End Stage Liver Disease
* Fatty Liver due to Hepatic Diseases other than Non Alcoholic Fatty Liver disease
* Concomitant severe clinical condition
Pilot Study of ONO-1101 in Patients Scheduled for Multi-slice CT

The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in patients scheduled for multi-slice CT.


Eligibility Criteria:
Inclusion Criteria:

1. 20-74 years old
2. Heart rate less than 90 beats/min more than 70 beats/min at entering the CT room

Exclusion Criteria:

1. Previous allergic reactions to contrast agent
2. Renal failure
3. Asthma
4. Other exclusion criteria as specified in the protocol
Post Operative Hemodynamic Function After Anesthetic Induction With Etomidate for Cardiac Surgery With ECC

Because of its hemodynamic safety, etomidate is widely used for anaesthesia induction of cardiac surgery. It can also cause adrenal insufficiency during the following 48 hours ( 11 betahydroxylase inhibition ). So it could increase hemodynamic dysfunction caused by the SIRS following cardiopulmonary bypass.

A previous observational study found more adrenal insufficiency and need for vasopressive support therapy in the etomidate group versus another propofol induced group.

The aim of our work is to compare hemodynamic dysfunction following induction with etomidate for cardiac surgery with ECC. The control group would be induced by Propofol. 94 patients would be included.

Information will be given at the anaesthetic consultation, few weeks before planed cardiac surgery. Eligibility and exclusion criteria will be checked. Patient will receive an informative written consent notice and all questions will be answered. A standard pre-operative blood collection will be sampled.

In order to minimize the potential confusing effect of daily cortisol variation, only surgical procedure performed early morning will be considered. The day before surgery definitive inclusion will be decided as the order of procedure is not known before. Only patients operated in the morning will be included because of cortisol daily variations. At this time, consent and information notice will be signed and checked in the medical record.

On the morning of surgery, during venous catheter insertion an additional blood sample will be collected to asses basal cortisolemia.

Randomisation will be carried out centrally after patient operative theatre admission, by phone call from ICU to randomisation office. Hypnotic drug will be prepared in the ICU department next to the operative room and blindly administered to patient ( same volume per weight ). All other anesthetic procedures will be standardised : opioid drugs, vasopressive support, antifibrinolytics and hemodynamic monitoring.

After surgery patients are admitted to surgical ICU. They will undergo standard post operative exams plus two corticotrophin tests and a dosage of SIRS markers ( IL6 and TNF alpha ). These results will only be known at the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* age superior to 18 years
* patient which had to be operated for aorto-coronary pass and/or valvular replacement

Exclusion Criteria:

* patient with aortics shrinking
* women pregnant or nursing
* contra-indication to etomidate or diprivan or synacthene
* patient with insufficiency kidney
* patient with infection
Prediction of Femoral Revascularization Quality Using the Somatic NIRS Signal

Despite effective femoral artery endarteriectomy, patients with occlusive arteritis may need complementary stenting of revascularization procedures within the 2 years after the primary surgery because of a poor blood supply in their lower limb extremity. The Near infrared spectrophotometry (NIRS) is a non-invasive monitoring of the brain or tissue oxygenation and provide information on the quality of the local oxygen supply. The aim of our observational study is to correlate the intraoperative NIRS variations at the calf and the soles and the one-year evolution of the arteritis.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing unilateral femoral endarteriectomy

Exclusion Criteria:

* emergency surgery, allergy to adhesive glues, skin abnormalities of the operated leg, multiple associated revascularization procedures other than endarteriectomy
Phase 1 Clinical Trial of DW340 and DW330SR + DW1030 Co-administration in Healthy Male Volunteers

A randomized, open-label, single-dose, crossover Phase I Study to investigate the relative bioavailability of DW340 and DW330SR + DW1030 co-administration in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Age at screening visit only 20 healthy men over the age of 40 years or less
* Screening visit, BMI measurement is more than 19 kg/m2 who are below 27 kg/m2
* Screening vist, 90 mmHg ≤ SBP ≤ 140 mmHg, 50 mmHg ≤ DBP ≤ 90 mmHg
* Fully understand the purpose of trial, test drug and follow the instructions of the trial, Those who voluntarily written consent that ability and decision to participate during the entire period of the test

Exclusion Criteria:

* Those with a clinically significant history or character; Liver, kidney, digestive, respiratory, musculoskeletal, endocrine, neuropsychiatric, blood • tumor type, cardiovascular disease
* Those with Gastrointestinal diseases that may affect the absorption of the IND or history of surgery
* Those who have a clinically significant history of hypersensitivity to drug and food
* Those with genetic problems, such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption
* Within 60 days those taking the other clinical trial drug
* Within 30 days those who take the drug metabolizing enzyme induction and inhibition drugs or prescription drugs
* Within 30 days those who take food abnormally, that may affect ADME of drug
* Within 60 days those who donate whole blood, within 30 days those who donate blood partially, receive transfusion
* Within 14 days those who take OTC drug
* Those who showing positive for drug abuse concerns in urine drug testing
* Those who drink excessive alcohol or have history of alcoholism
* Heavy smoker
* and so on
A Study to Determine the Absorption, Distribution, Metabolism, and Excretion of LBH589

This single center study will help determine the absorption, metabolism, and excretion of LBH589 and to assess the safety and efficacy of LBH589 in advanced cancer patients for whom no standard therapy exists.


Eligibility Criteria:
Inclusion criteria

* Histologically or cytologically confirmed cancer patients including solid tumors, lymphoma, or chronic hematological malignancies with progression on prior standard therapies.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of \< 2
* Normal renal and hepatic function

Exclusion criteria

* Patients with central nervous system (CNS) involvement or brain metastases
* Patients who have received chemotherapy, any investigational drug, undergone major surgery, or received wide field radiotherapy less than 4 weeks ago
* Patients with congenital long QT syndrome or uncontrolled hypertension
* Patients with a myocardial infarction or unstable angina within 6 months
* Congestive heart failure
* Impairment of gastrointestinal (GI) function
* Use of any anti-cancer therapy
* Female patients who are pregnant or breast feeding

Other protocol inclusion/exclusion criteria may apply.
Fecal Microbiota Transplantation for the Treatment of Metabolic Syndrome

Obesity is associated with changes in the composition and metabolic function of the gut microbiota. Fecal microbiota transplantation (FMT), also known as "fecal bacteriotherapy" or "fecal infusion", refers to the process of injecting a liquid suspension of stool from a healthy donor into the gastrointestinal (GI) tract of a patient to cure a specific disease. However, since the recently established concept of human gut microbiome and its significant role in health and disease has caught on in the medical scientific world, this procedure has gained a great pathophysiological strength, meaning not only the simple infusion of stools, but the transplantation of a healthy gut microbiota in a patient with a disrupted one. In a recent dutch experience, FMT from lean donors was able to increase the insulin sensitivity in patients with metabolic syndrome.

Our primary aim is to evaluate if FMT from lean healthy donors, in association to lifestyle changes, is able to reduce insulin-resistance more than lifestyle changes alone in patients with metabolic syndrome.

All the patients with metabolic syndrome will receive lifestyle counselling (1400 kilocalories diet and physical activity encouragement), than will be randomized to FMT from healthy lean donors by upper endoscopy (group A) or no treatment (group B)


Eligibility Criteria:
Inclusion Criteria:

* Both males and females between 30 and 60 years old
* BMI\>30 and \>35 kg/m2
* Diagnosis of Metabolic Syndrome according to National Cholesterol Education Program's Adult Treatment Panel III criteria
* No ongoing therapy for diabetes, hyperlipidemia or arterial hypertension
* Signature of written informed consent

Exclusion Criteria:

* recent (3 months) use of probiotic, antibiotics or other drugs
* Increase in triglycerides levels, (≥ 300 mg/dl), LDL levels (≥ 190 mg/dl, or modification of body weight (±5%) during the last 3 months
* Relevant cardiovascular diseases or kidney diseases
* Relevant gastrointestinal diseases (such as inflammatory bowel disease or celiac disease)
* Former gastrointestinal surgery
"Steroids and Azathioprine Versus Steroids Alone in IgAN"

In a previous trial the investigators found that the effect of steroids in IgA nephropathy diminish over time. The difference in renal survival is striking up till the third year, but then remains constant. A six-month course of steroid therapy may be not enough to ensure a stable remission. The investigators hypothesized that a more aggressive treatment may obtain long-term better results. The investigators conducted a randomised controlled trial to assess the utility of low-dose azathioprine added to steroids in adult IgAN patients.

In 1999, we published a multicenter, randomized, controlled trial, which compared a 6-month steroid course with supportive therapy in 86 patients with IgAN. After 5 years of follow-up, the risk of a 50% increase in plasma creatinine from baseline was significantly lower in the treated patients; proteinuria also decreased. However, the effect of steroids seemed to diminish over time. The difference in renal survival was particularly striking up till the third year, but then remained constant. We hypothesised that a six-month course of steroid therapy is not enough to ensure a stable remission, and a more aggressive treatment may be required to obtain long-term better results. At this regard, some studies of combined treatment with corticosteroids and azathioprine found that treatment was effective in preserving renal function and in reducing proteinuria. However, these studies did not clarify whether azathioprine added further benefit to steroids in the long term. We conducted a randomised controlled trial to assess the utility of low-dose azathioprine added to steroids in adult IgAN patients.

Eligibility Criteria:
Inclusion Criteria:

* biopsy proven IgA nephropathy
* creatinine ≤ 2.0 mg/dl for at least three months
* proteinuria ≥ 1.0 g/day for at least three months

Exclusion Criteria:

* treatment with steroids or cytotoxic drugs during the previous three years
* contraindications to steroids or azathioprine
* Henoch-Schöenlein purpura
* diabetes mellitus
* severe hypertension (diastolic blood pressure \> 120 mmHg)
* lupus erythematosus systemicus
* malignancies
* active peptic-ulcer disease
* pregnancy
* viral hepatitis or other infections
The Effectiveness of Motivational Interviewing in Reducing the Use of Household Chemicals and Personal Care Products During Pregnancy

Objective: The aim of the study is to examine the effect of motivational interviewing on reducing the use of household chemicals and personal care products during pregnancy.

Introduction :During pregnancy, women are exposed to cosmetic products and household chemicals frequently used in daily life.

Method: The research was conducted in a prospective pre-test, post-test based randomized controlled experimental research design.The sample of the study consisted of 140 pregnant women who applied to the Ministry of Health Istanbul Provincial Health Directorate and Sile State Hospital Gynecology and Obstetrics Polyclinics between May and December 2023, volunteered to participate in the study and met the inclusion criteria.

Firstly, the Informed Consent Form and Introductory Information Form were applied to the women, then the Personal Care Products Use Evaluation Form, Self-Efficacy Scale and Endocrine Disruptors Attitude Scale were applied. The experimental group was informed about the motivational interviewing technique and an appropriate plan was made. After the interviews, the Personal Care Products Use Evaluation Form, Self-Efficacy Scale and Endocrine Disruptors Attitude Scale were re-administered.

Eligibility Criteria:
Inclusion Criteria:

* Being at least 18 years old
* Education level must be at least primary school
* Speaking Turkish
* Having a single pregnancy between the 8th and 40th weeks
* Using household chemicals and personal care products (any product at least once a week)

Exclusion Criteria:

* Having a psychiatric illness that prevents communication,
* Having a chronic serious physical health problem
* Termination of pregnancy for any reason
* Having a risky pregnancy (preeclampsia, threat of premature birth)
* Intrauterine growth retardation, having a pregnancy with fetal anomalies
* Working in a job that requires heavy use of chemicals, such as hairdresser, dry cleaner, beautician.
Personalized Treatment

The Personalized Treatment Study creates an individualized network of symptoms for a participant with a current eating disorder. This network will be used to develop a personalized treatment intervention. This study aims to 1) determine if personalized treatments can be conducted using a network analysis of patient symptoms, and 2) to assess the effectiveness of network-informed personalized treatment for participants with eating disorders.

Cognitive behavioral theory proposes that cognitions, behaviors, affect, and physiological symptoms interact with each other to maintain and exacerbate psychiatric disorders (Beck, 2011). Network theory identifies core symptoms that maintain and promote the spread of ED psychopathology within individuals (Borsboom \& Cramer, 2013). Once identified, core "trigger" symptoms can be directly targeted to disrupt the spread or "activation" of ED behaviors, which would help patients achieve full recovery, and ultimately, prevent relapse. One of the main goals of the Personalized Treatment Study is to create an individualized network for a participant with a current eating disorder, which can be used to develop a personalized treatment intervention. Our research questions are: 1) Can a personalized treatment plan be conducted from a network analysis of patient symptoms, and 2) How effective is this personalized treatment based off of a network of symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Current eating disorder diagnosis
* at least 18 years of age,
* not actively suicidal,
* not manic,
* not psychotic

Exclusion Criteria:

* No current eating disorder diagnosis,
* younger than 18 years of age,
* active psychosis,
* active mania, or
* actively suicidal.
Different Preloads for Prevention of Hypotension in Patients Undergoing Elective CS Under Intrathecal Anesthesia

The aim of this study was to compare between crystalloid versus crystalloid and colloid combination preloads for prevention of hypotension following intrathecal anaesthesia in patients undergoing elective Caesarean section.

To examine weather baseline perfusion index could predict the incidence of intrathecal-induced hypotension during Caesarean section.

Intrathecal anesthesia is the most commonly used technique for elective Caesarean section all over the world.

One of the most common complications of this technique is hypotension. It's incidence is more than 80% without any prophylactic measures, this hypotension has adverse effects on both mother ( causing nausea and vomiting ) and foetus ( causing acidosis and neurological defects ).

This complication can be managed by several ways like fluid therapy, usage of vasopressors or combination between both of them.

Among the type of fluids ( crystalloid or colloid ) it's still not known which one of them is better. Crystalloid has a short intravascular half-life because of its rapid distribution into the interstitial space. On the other hand colloid remains longer within the intravascular space.

Change in baseline peripheral vascular tone due to pregnancy may affect the degree of such hypotension. The perfusion index ( PI ) derived from a pulse oximeter has been used for assessing peripheral perfusion dynamics due to changes in peripheral vascular tone.

Eligibility Criteria:
Inclusion Criteria:

* Age : 18-40 years
* ASA 1\&2

Exclusion Criteria:

* Patients with morbid obesity.
* Pre-existing or pregnancy-induced hypertension.
* Known cardiovascular or cerebrovascular disease.
* Abnormal CTG tracing.
* Any other contraindications for intrathecal anaesthesia.
Sleep Apnea and Refractory Hypertension: Prevalence and Effect of CPAP Treatment

A small number of uncontrolled studies have shown a high prevalence of sleep apnea in patients with refractory hypertension and that CPAP treatment achieves a significant reduction of blood pressure in the short term.

The purpose of this study is to assess the prevalence of sleep apnea in patients with refractory hypertension, and the effects of continuous positive pressure treatment on systemic blood pressure and on serum markers of endothelial dysfunction and angiogenesis.

We assess the prevalence of an apnea hypopnea index (AHI) \> 5 in patients with refractory hypertension referred from a hypertension clinic. Patients with an AHI \>15 are randomized to either continuing their usual pharmacological treatment alone or adding CPAP to their usual treatment, during a 3 month period.

The main endpoint is the comparison of the mean 24h systolic and diastolic blood pressure, as assessed by ambulatory blood pressure monitoring, between both treatment arms. The secondary endpoint is to assess changes in serum markers of endothelial dysfunction and angiogenesis

Eligibility Criteria:
Inclusion Criteria:

* Patients referred from a tertiary hospital hypertension clinic with a diagnosis of refractory hypertension on the basis of office blood pressure higher then 160/90 mmHg despite the recommended doses of at least 3 drugs, including a diuretic.

Exclusion Criteria:

* Causes of secondary hypertension, history of alcohol abuse , renal insufficiency, severe chronically illness.