cyrilzakka/clinical-trials huggingface dataset:
Developing the Probability Algorithm for Pulmonary Hypertension Echocardiography

The goal of this observational study is to assess the efficacy that the addition of novel markers cardiac function, particularly of right ventricular (RV) function in echocardiography, and ECG have in detecting pulmonary hypertension.

The main questions it aims to answer are:

Can novel markers in ECG and echocardiography suggest the presence of PH? Can existing screening guidelines be improved with the addition of these markers?

Pulmonary Hypertension (PH) is a condition caused by high blood pressure in the blood vessels that carry blood to the lungs. It can cause severe breathlessness and failure of the right side of the heart. Sadly it is often fatal.

PH can be caused by a number of different conditions and life expectancy varies with the underlying cause, ranging from months to years. For some subtypes of PH, effective treatments exist which can significantly improve life expectancy and quality of life. Accurate tools for the assessment of PH are therefore essential, so that we can better understand and predict life expectancy and so that life-saving medications can be started earlier.

Once doctors suspect that somebody has PH, they refer them to a specialist PH centre for assessment and a procedure called right heart catheterisation (RHC), which will confirm the diagnosis. However, evidence for the suspicion of PH is frequently overlooked, leading to an average delay to diagnosis from onset of symptoms of two years. This late presentation negatively impacts survival for these patients and prevents them promptly starting the effective treatments which are available.

An electrocardiogram (ECG) is a recording of the heart's electrical signals, printed in waveforms. It is a painless, low-cost, and readily-available test used in PH assessment.

Echocardiography (echo) is a quick, safe and well-tolerated test often requested to investigate breathless patients and can provide useful information about the suspicion of PH. Echo has however been shown to lack accuracy in milder forms of the disease. It has been hypothesised that subtle markers of right ventricular function by echo, such as free wall strain (RVFWS) begin to deteriorate before the more established findings.

A large, cross-population study of ECG features and echo markers such as RVFWS both in isolation and in combination, in patients referred for PH assessment may help identify these markers, and improve detection of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients 18+ who have undergone TTE, ECG and RHC as part of their clinical care

Exclusion Criteria:

* Patients \<18 years old
* Known or suspected congenital heart disease
* Patient has opted-out of allowing their data to be used for research and planning (via the national data opt-out choice in England, or equivalent data protection scheme in Scotland)
Measurement of Hemodynamic Responses to Lower Body Negative Pressure

This study will be collecting data on participants undergoing lower body negative pressure (LBNP) to simulate progressive blood loss. The goal of the study is to collect data to allow for development of an algorithm with machine learning to predict blood pressure responses to hypovolemia by analyzing the arterial waveforms collected during LBNP.

Death from exsanguination continues to be a major problem in combat casualty care and the care of civilians subjected to trauma. The ability to detect significant blood loss using traditional vital signs (heart rate, blood pressure) is marginal due to a variety of compensatory mechanisms that maintain blood pressure in the face of marked reductions in circulating blood volume. Along these lines, it is critical to develop monitoring devices and algorithms to non-invasively assess central blood volume in humans for the purposes of facilitating more timely interventions. The standard way to simulate hemorrhage in humans is to use Lower Body Negative Pressure (LBNP). In this technique, the lower body of a supine volunteer is enclosed in an airtight container while suction is applied to cause venous pooling in the legs and reduce central blood volume. This technique generates many physiological adaptations that are similar to that observed during blood loss studies in animals and human volunteers. Thus, the purpose of this study is to obtain data for use in developing monitoring technology to detect hemorrhage and other surrogate markers of central blood volume in humans.

Eligibility Criteria:
Inclusion criteria:

18-55 year of age Non-smoker No history of hypertension No history of diabetes No history of coronary artery disease No history of neurologic disease

Exclusion criteria Prescribed medications other than birth control Inability to lie flat for two hours BMI \> 30 kg/m2
Effect of a Vitamin D Analogue vs Placebo on p-NT-proBNP in Patients With Type 1 DM and Diabetic Nephropathy

The primary objective is to assess the impact of three months of treatment with an active vitamin D analogue on a risk marker for excess overall mortality and cardiovascular morbidity/mortality in Type 1 diabetic patients with diabetic kidney disease. The hypothesis is that active vitamin D analogue treatment reduces the risk of cardiovascular morbidity and mortality in patients with type 1 diabetic kidney disease.


Eligibility Criteria:
Inclusion Criteria:

* 18-75 years of age
* Type 1 diabetes mellitus
* Diabetic nephropathy (defined by persistent albuminuria, \> 300 mg/24 hr or 200µg/min in 2 of 3 consecutive samples, presence of diabetic retinopathy and absence of clinical or laboratory evidence of other kidney or renal tract disease
* Chronic kidney disease stage 3 and 4
* S-Parathyroid hormone (s-PTH)\> 35pg/ml
* Stabile RAAS-blocking and diuretic treatment

Exclusion Criteria:

* Other kidney disease than diabetic nephropathy
* Myocardial infarction within the last three months prior to visit 1
* Coronary artery revascularization within the last three months prior to visit 1
* Transitional cerebral ischemia (TCI) or apoplexia within the last three months prior to visit 1
* Cardiac Failure (NYHA Class III or IV)
* Kidney Failure (GFR \<15ml/min), dialysis, kidney transplantation)
* Liver disease with serum alanine aminotransferase (ALT\>3 x the normal value
* Alcohol/drug abuse
* Hypercalcemia (serum ionized calcium \>1.35 mmol /L)
* Medication with phosphate and/or vitamin D-containing medications, which can not be paused during the study
* Clinical signs of vitamin D toxicity
* Pregnant or nursing women
* Fertile women not using chemical or mechanical (IUD) contraceptive methods
* Current disulfiram treatment
* Allergy to the study drug
* Patient unable to understand the informed consent
* Any other condition or therapy which, in the opinion of the investigator, makes the patient not suited for participation.
A Switch Study of BMS-337039 in Schizophrenic Out-patients

The purpose of this clinical research study is to evaluate the safety and tolerability of two switching strategies from risperidone to aripiprazole over a period of 12 weeks in out-patients who are treated in a general psychiatric practice setting and who are currently experiencing efficacy and/or safety/tolerability issues while on risperidone.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of schizophrenia as defined by DSM-IV-TR2 criteria
* Out-patients who have been taking Risperidone for minimum 6 weeks who are not optimally controlled and/or experiencing safety/tolerability issues with Risperidone
* Men and women, aged 18 - 65 years

Exclusion Criteria:

* Patients who are at risk for committing suicide
* Patients with a diagnosis of schizoaffective disorder, bipolar disorder, depression with psychotic symptoms, or organic brain syndromes
* Meeting DSM-IV-TR criteria for any significant Psychoactive Substance Use Disorder within the 3 months prior to Screening
* Treatment-resistant to antipsychotic medication
Risk of Ectopic Pregnancy and Variation of Luteal Estradiol and Progesterone Levels in IVF

This study evaluates the increased risk of ectopic pregnancy associated with marked variation of estradiol during the early luteal phase and high progesterone on hCG day in IVF.

This is a retrospective cohort study of 578 patients who had no risk of EP (672 fresh transfer IVF cycles) between January 2005 and December 2014. Few studies have reported the relation between hormonal levels and ectopic pregnancy (EP) in IVF. Investigators describe EP incidence according to estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7) or their variation between both days.

Eligibility Criteria:
Inclusion Criteria:

* Normal Fallopian tubes in HSG and /or laparoscopy
* Normal Uterus: Abscence of myomas and Müllerian anomalies .

Exclusion Criteria:

* Previous Ectopic Pregnancy .
* Recurrent Abortion .
* Tubal Factor : pelvic inflammatory disease, Hydrosalpinx
* Previous abdominal surgery (except laparoscopy) .
* Prior Peritonitis
* Smoking (at least 1 cigarette/day) .
Finger Feeding as a Method of HMF Supplementation After Discharge

Human Milk Fortifier (HMF) is designed to supply additional calories, protein, vitamins and minerals to infants less than 37 weeks gestation or those less than 1500 g at birth. Liquid and powder types of HMF are available in the commercial market. Usually, one packet of powdered HMF is mixed to 25-50 cc expressed breast milk. Fortification of human milk is technically difficult in fully breastfed infants and artificial teats such as bottle feedings are common used. A study reported lower breastfeeding rate in intervention group who used HMF in comparison with control. Finger feeding method is associated with a better breastfeeding rate in hospital use. A feasibility study in Vienna reports finger feeding method as a way to provide fortification at home was acceptable.We hypothesize that finger feeding is an easy way for HMF supplementation after discharge to increase successful breastfeeding and improve growth in preterm and or low birth weight infants.

For infants with very low birth weight (\<1500 g) convincing evidence indicates that providing multi-nutrients fortification including protein, long-chain polyunsaturated fatty acid, and micro-nutrients improves infant growth during hospitalization and health outcomes. A study of predominantly breastfed preterm infants with fortification after discharge shows better growth than unsupplemented counterparts at 3 months corrected age. Another study showed that post discharged growth of \< 1800 g infants with human milk fortifier (HMF) supplementation until 48 weeks gestational age improved. But without the intensive lactation counselling the breast milk in HMF group were lower than control group if artificial teats were used. 4. Finger feeding is an alternative method to feed infants to increase successful breastfeeding, but unpopular in Indonesia. Study on finger feeding are still limited and most study of them are not randomized trial. We evaluate the method of supplementation on breastfeeding rate, growth and safety. We also do in depth interview with those who have high or low compliance.

Eligibility Criteria:
Inclusion Criteria:

* birth weight \< 2500 g
* need HMF supplementation after discharge
* predominantly breastfed
* live in Jakarta city and its surrounding
* parents agree to follow study procedure with signed informed consent

Exclusion Criteria:

* major congenital anomaly or other conditions interfere with normal growth and oral feeding
Efficacy and Safety of Auto-FMT in Preventing aGVHD

To evaluation the efficacy and safety of autologous fecal bacteria transplantation in preventing acute graft versus host disease after haploidentical hematopoietic stem cell transplantation. Bone marrow transplant patients were recruited.


Eligibility Criteria:
Inclusion Criteria:

* Haplo-HSCT patients; Bacteroidetes \>0.1%; inverse Simpson diversity ≥2

Exclusion Criteria:

* Gastrointestinal diseases；Age\>60; or Age\<10；Probiotics or prebiotics were taken before enrollment
Comparison of the ProAdjuster Analysis to the Penning Method of Determining Intersegmental Motion of the Cervical Spine

The purpose of this study is to determine if the ProAdjuster system of analysis can be used to determine cervical spine instability using the Penning system of radiographic marking as a standard of comparison.

This study will utilize the ProAdjuster Device as a method of assessing the motion of the cervical spine in participants with instability as determined by a Penning Radiographic analysis. Only participants with existing radiographic studies will be included in the study. No additional Radiographic will be required.

Eligibility Criteria:
Inclusion Criteria: Logan student, staff, or faculty with no history of ankle injury; 2. Age 18 - 60 yoa.

Exclusion Criteria: 1. Logan student, staff, or faculty ; 2. Local infection, injury or other malignancy affecting the cervical spine; 3. Any unstable joints of the cervical spine than require immobilization ; 4. Any manipulation to cervical spine within 48 hours; 5. Pregnancy.
Physical Exercise Prehabilitation Program in MEtabolic SuRgery

The goal of this clinical trial is to learn if an exercise program before bariatric surgery works to treat obesity, could improve physical condition and weight loss before bariatric surgery and induce a lifestyle behavior change. The main questions it aims to answer are:

* Does a supervised exercise program lead to improved physical condition prior to bariatric surgery?
* Does a supervised exercise program prior to bariatric surgery lead to reduced surgery related complications?
* Does a supervised exercise program prior to bariatric surgery lead to maintained lifestyle changes after surgery?

Participants will:

* Receive either no training program or physical exercise training program twice a week, supervised by a physical therapist, for a duration of 8 weeks.
* Have their fitness measured at the start and at the end of the 8 weeks, measured with a six minute walking test.
* Fill in a survey on their perceived quality of life and exercise habits at the start of the trial, and at 1 year after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years)
* Body-Mass-Index (BMI) 40 kg/m2 or higher, or 35 kg/m2 or higher with the presence of at least one comorbidity (type 2 diabetes, high blood pressure, heart and/or vascular diseases, obstructive sleep apnea (OSA), dyslipidemia, or arthritis).
* Primary bariatric patients; without previous bariatric surgery. For inclusion the investigators will follow the National Guidelines on metabolic surgery.

Exclusion Criteria:

Patients with:

* mobility problems (patients who are not able to exercise)
* cognitive disabilities
* illiteracy (patients who are not able to read and understand the language of the country where the study will be performed)
A Communication Strategy for Families of Patients Dying in the ICU

Decisions to limit life sustaining treatments are made for most patients dying in the ICU, usually with input from the family. The well-being of the family may be jeopardized by involvement in the decision-making process and bereavement. We evaluated the ability of a proactive communication strategy (family conference and providing family members with a bereavement information leaflet) designed to improve family well-being.


Eligibility Criteria:
Inclusion Criteria:

* family of dying patient

Exclusion Criteria:

* family having no enough knowledge of French to respond to telephone interview
* patient alive on day 90
Serum Brain Natriuretic Peptide Levels and Pulmonary Hypertension in Pediatric Sickle Cell Patients

The purpose of this study is

1. To determine if Brain natriuretic peptide levels correlates with elevated tricuspid regurgitation flow velocity levels in pediatric patients with sickle cell disease
2. To determine the role of age, gender, steady state hemoglobin and disease type on Brain natriuretic peptide levels and pulmonary hypertension

Pulmonary hypertension is recognized as a significant cause of morbidity and mortality in patients with sickle cell disease. Doppler echocardiography is a recommended noninvasive screening tool for sickle cell disease patients with pulmonary hypertension. Brain natriuretic peptide levels have been found to be a possible serum screening marker. This research will offer the opportunity to determine if there is any possible relationship between magnitude of BNP concentration and degree of TRV, if it can be used as a screening test in SCD pediatric patients with PHT and form the basis for a future multicenter study

Eligibility Criteria:
Inclusion Criteria:

* Male and Female any age
* Diagnosis of SCD with PHT on echocardiogram
* Controls must have a diagnosis of sickle cell disease without Pulmonary hypertension, age, gender and disease type match to subjects with pulmonary hypertension
* Parent or Legal guardian willing to sign informed consent form

Exclusion Criteria:

* Abnormal echocardiograms not related to PHT
* Parent or Legal guardian unwilling or unable to give written informed consent
Avapritinib Rollover Study

The primary objective of the rollover study is to evaluate the long-term safety of avapritinib in participants who have completed a Blueprint Medicines sponsored study (parent study) and continued to benefit from avapritinib.


Eligibility Criteria:
Inclusion Criteria:

* Participated in a Blueprint Medicines sponsored avapritinib clinical study. The Sponsor reserves the right to not roll over patients who have been on drug hold for an extended time period.
* Completed End of Trial / End of Study (EOT/EOS) visit in the parent study and demonstrated compliance with the parent study requirements.
* Continue to clinically benefit from treatment with avapritinib.
* Able to give written informed consent.
* Agree to continue to use highly effective contraception as defined in this protocol.
* Female patients of childbearing potential must have negative highly sensitive serum pregnancy test within 20 days before the first dose of avapritinib. Women of nonchildbearing potential do not require this test.

Exclusion Criteria:

* Participant is participating in another interventional study.
* Participant is unwilling or unable to comply with study procedures and study restrictions.
* Participant is breastfeeding.

Other protocol-defined criteria apply.
Prophylactic Negative Pressure Wound Therapy for High Risk Laparotomy Wounds. A Randomized Prospective Clinical Trial.

Negative pressure wound closure technique (NPWT) has been widely introduced in different clinical settings. Most of the studies report it as an effective and cost-effective method to treat complicated surgical wounds or even open abdomen.

NPWT as a prophylactic effort to prevent complications of high risk surgical wounds has recently been introduced, but the concept is still lacking clinical evidence in terms of clinical effectiveness and cost effectiveness.

In this randomized, multi centric study investigators aim to compare prophylactic negative pressure wound closure (ciNPWT) with traditional, dry wound dressing at high infection risk laparotomy wounds.

The aim is to compare ciNPWT (closed incisional negative pressure wound dress) technique to the traditional, dry wound dressing technique at high infection risk laparotomy wounds.

Control arm will be treated "as usual": sterile gauze or high-absorbing surgical wound dress.

Experimental arm will be dressed with: one layer of silver-containing, impregnated mesh laxer (Atrauman® Ag - Hartmann) directly placed on the primary closed wound, one layer of alcohol-soaked foam (VivanoMed® White Foam - Hartmann) and sufficient-size sealant film (Hydrofilm® - Hartmann).

A negative pressure of -90 Hgmm will be administered in a continuous mode over 5 days postoperatively.

Surgical site infection and abdominal wall dehiscence rate will be assessed, as well as cost effectiveness will be calculated at both arms.

Eligibility Criteria:
Inclusion Criteria:

* High risk laparotomy patients. SSI risk at least 3x higher than normal rate (6-8%)
* Surgical wound type III or IV..

Exclusion Criteria:

* Patients not giving informed consent.
* Patients requiring open abdominal wound care.
* Patients with abdominal wall malignancy,
* Patients with peritoneal carcinomatosis,
* Patients who are planned for second look laparotomy within 5 days,
* Patients with less thank 3 month life expectancy.
* Patients who are operated with existing wound infection
Interest of Gentamicin-induced Readthrough in Cystic Fibrosis Patients

Suppression of stop mutations in the CFTR gene with parenteral gentamicin can be predicted in vitro and is associated with clinical benefit and significant modification of the CFTR-mediated chloride transport in nasal and sweat gland epithelium.

Background: This study was conducted to determine whether intravenous gentamicin can suppress stop codons in cystic fibrosis (CF) patients and, if so, whether it has any clinical benefits.

Methods: We first used a dual gene reporter system to determine the gentamicin-induced readthrough level of the most frequent CFTR stop mutations in the French population. We next investigated readthrough efficiency in response to 10 mg/kg once daily intravenous gentamicin perfusions in patients with stop mutations and in a control group of patients without stop mutations. Respiratory function, sweat chloride concentration, nasal potential difference (NPD) and CFTR expression in nasal epithelial cells were measured at baseline and after 15 days of treatment.

Results: After in vitro gentamicin incubation, the readthrough efficiency for the Y122X mutation was at least five times higher than that for G542X, R1162X, and W1282X. In six of the nine patients with the Y122X mutation, CFTR immunodetection showed protein expression at the membrane of the nasal ciliated cells and the CFTR-dependent chloride secretion in their NPD measurements increased significantly. Respiratory status also improved in these patients, irrespective of the gentamicin sensitivity of the germs present in the sputum. Mean sweat chloride concentration decreased significantly and normalized in two patients. These measurements did not change in the Y122X patients with no protein expression, in patients with the other stop mutations investigated in vitro (n=4) and those without stop mutations (n=5).

Conclusion: Suppression of stop mutations in the CFTR gene with parenteral gentamicin can be predicted in vitro and is associated with clinical benefit and significant modification of the CFTR-mediated chloride transport in nasal and sweat gland epithelium.

Eligibility Criteria:
Inclusion Criteria:

* cystic fibrosis with CFTR codon stop mutations

Exclusion Criteria:

* Rhinitis
* nasal polyposis
* passive or active smoking
* modification of basal treatments within the previous month
* treatments with aminoglycosides within three previous months
Pressure and Temperature Sensor for Therapeutic Compression Garments

Pilot study of a soft, flexible pressure and temperature sensor

Assessment of safety, and preliminary accuracy of a pressure and temperature sensor adherent to the skin. The pressure sensor includes a piezoresistive fabric coupled to a near-field communication chip with a built-in temperature sensor.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults over the age of 18 years old

Exclusion Criteria:

* Subjects with history of medical or surgical problems