cyrilzakka/clinical-trials huggingface dataset:
Cerebrovascular Reserve Measurements in Sickle Cell Disease

The primary aim of this study is to evaluate MRI-based cerebrovascular reserve (CVR) measurements in adult patients with Sickle Cell Disease (SCD).

The primary objective is to assess whether there is a correlation between CVR and silent cerebral infarcts (SCIs).

CVR is hypothesized to be impaired in SCD patients and could account for the white matter hyperintensities seen on MRI in these patients. Cerebral blood flow (CBF) alone is not sufficient to provide insight into the hemodynamic status of the brain. CVR allows us to gain insight into the capacity of the cerebrovasculature to respond to increased CBF. Vasculopathy is common in SCD and the caliber of the vessels can be assessed with 4D Flow MRI in response to actue and chronic changes in the velocity and wall shear stress on the intracranial arteries in the Circle of Willis.

This study will be performed as a single center, patient-control, cross-sectional, observational study in patients with steady-state SCD and controls. The investigators expect that patients with impaired CVR will have a greater number and/or volume of SCIs.

Eligibility Criteria:
Inclusion Criteria Patient group:

* Sickle cell disease; either homozygous sickle cell disease (HbSS), or HbSβ0 thalassemia
* 18 years of age or older
* Informed consent

Inclusion Criteria Control group:

* Similar ethnic background as Patient group
* 18 years of age or older
* Informed consent

Exclusion Criteria Patient group and Control group:

* Inability of the patient to provide informed consent or legally incompetent/incapacitated to do so
* Contraindications for MRI, such as pregnancy, claustrophobia or the presence of metal in the body
* Sickle cell crisis at the moment of participation
* History of cerebral pathology that compromises measurements, such as cerebral palsy, brain tumour,meningitis, overt infarct
* Brain surgery performed in the last 3 months
* Severe liver, heart or renal dysfunction (clearance \< 10 mL/min)
* Allergy to sulphonamide
* Breastfeeding
* Use of phenytoin, procaine or acetylsacylic acid ("Ascal/aspirin")
* Risk of hypokalaemia (use of diuretics, primary hyperaldosteronism)
* Addison's Disease
* Severe asthma or emphysema
Topical Tranexamic Acid Application in Rhinoplasty

The aim of this study is to examine the effectiveness of topical Tranexamic acid application in overcoming periorbital ecchymosis and edema after rhinoplasty, which are common and do not have a standard treatment.

All patients were informed individually about the procedures and written informed consent was obtained before the study. Patients who underwent rhinoplasty / septorhinoplasty operation between June 2021 and September 2021 with open technique were included in the study. Two groups with at least 25 individuals in each group were included in the study. Patients were appointed to either the control or TA group in a randomized-consecutive fashion. Patients younger than 18 years or older than 60 years, patients with a history of previous nasal operations, chronic medical conditions, hematologic disorders, fibrinolytic disorders and known allergy to tranexamic acid were excluded from the study. In group TA, TA-soaked pledgets were placed under the skin flap in such a way that both sides reach the osteotomy area and left for 5 minutes. In control group, isotonic saline-soaked pledgets were placed under the skin flap in the same way and left for 5 minutes. Surgical pledgets were prepared by nurse and given to the surgeon who did not know which group the pledget belonged to. Digital photographs were obtained by the surgeon who performed the operation on the first, third and seventh postoperative days. Eyelid edema and periorbital ecchymosis were scored via digital photographs separately by two expert surgeons at our institution independently using a graded scale ranging from 0 to 4. Digital photographs of the patients were shown to the examiners in alphabetical order, and information on which groups the patients belonged to was not given. The scores obtained from two different examiners were averaged. Statistical analyses were performed using IBM SPSS for Windows (IBM Corp., version 26.0, Armonk, NY, USA). The gender distribution of the groups was presented by number and percentage. Age, ecchymosis and edema degrees were presented by mean ± SD and median (minimum-maximum) values. The Chi-square test was used to compare the gender distribution of the groups. The patients' ecchymosis and edema scores were compared among groups using a Mann-Whitney U test. Comparisons within each group was evaluated with repeated measures analysis of variance test (Friedman test); if a difference was detected, the Wilcoxon signed rank test with Bonferroni correction was used to determine the group that made a difference. P ≤ .05 was considered statistically significant.

Eligibility Criteria:
Inclusion Criteria:

* primary open approach rhinoplasty under general anesthesia
* bilateral lateral osteotomies

Exclusion Criteria:

* Patients younger than 18 years
* Patients older than 60 years
* history of previous nasal operations
* chronic medical conditions,
* hematologic disorders
* known allergy to tranexamic acid
EBUS-GS-TBLB With or Without Fluoroscopy for the Diagnosis of PPLs

The purpose of this study is to evaluate the efficacy and safety of endobronchial ultrasound-guide sheath(EBUS-GS) for the diagnosis of peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.

The investigators evaluated the efficacy and safety of transbronchial biopsy (TBB) and bronchial brushing by endobronchial ultrasonography (EBUS) with a guide sheath (GS) as a guide for diagnosing peripheral pulmonary lesions (PPLs) without radiographic fluoroscopy.The study is designed as a two-center prospective randomized controlled trial. The participating centers are Department of pulmonary medicine and endoscope center, Shanghai chest Hospital affiliated to Shanghai JiaoTong University School, China. Department of pulmonary medicine, Fukushima Medical University, Japan.Patients are divided into two groups, EBUS-GS-X-ray group and EBUS-GS group.Each subject will be randomized to each group.The study is expected to enroll 100 patients at 2 centers (China:75, Fukushima:25).

Eligibility Criteria:
Inclusion Criteria:

1. Individuals eligible for inclusion are patients that the CT scan appearance of the PPLs showed the longest diameter was more than 2 cm and solid lesions.

Exclusion Criteria:

1. The lesion is close to the pleural membrane
2. Refusal of participation
3. Severe cardiopulmonary dysfunction and other indications that can't receive bronchoscopy
Pelvic Floor Exercise Before Surgery in Women With Pelvic Organ Prolapse

The lifetime risk for a woman to undergo surgery for either vaginal prolapse or urinary incontinence is high. There are many different surgical techniques for treatment of prolapse, but there is a lack of knowledge about factors that contribute to objective result and patient satisfaction after surgery.

The aim of the study is to investigate factors that could be related to patient satisfaction and objective result such as pelvic floor muscle contractility/strength and muscle injury, objective measures of prolapse and women's symptoms. This study will investigate whether systematic pelvic floor exercise and life style advise before surgery can improve outcomes after surgery for either vaginal prolapse. Another aim is to determine an ultrasound scale for measure of pelvic floor muscle contraction.


Eligibility Criteria:
Inclusion Criteria:

* referred to surgery for urogenital prolapse
* informed consent

Exclusion Criteria:

* not able to communicate in Norwegian or English
* not able or willing to sign informed consent
Polidocanol Endovenous Microfoam (PEM) Versus Vehicle for the Treatment of Saphenofemoral Junction (SFJ) Incompetence

Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and may cause discomfort. In this study, patients with varicose veins in the legs will be participating. The purpose of this research study is to evaluate the safety and effectiveness of three different concentrations of an investigational drug, Polidocanol Endovenous Microfoam (PEM) compared to vehicle (inactive solution) in treating the symptoms and appearance of varicose veins.


Eligibility Criteria:
Inclusion Criteria:

* Incompetence of SFJ associated with incompetence of the GSV or other major accessory vein
* Ability to comprehend and sign an informed consent document and complete study questionnaires in English
* Ability to record symptoms in accordance with the protocol
* Symptomatic varicose veins
* Visible varicose veins

Exclusion Criteria:

* Patients who only have telangiectatic or reticular veins (Clinical Finding C1, as assessed by CEAP Classification of Venous Disorders).
* Leg obesity impairing the ability to access the vein to be treated and/or to apply post-procedure compression bandaging and stockings
* Ultrasonographic or other evidence of current or previous deep vein thrombosis or occlusion
* Deep vein reflux unless clinically insignificant in comparison to superficial reflux
* Peripheral arterial disease precluding the wearing of post-procedure compression bandaging and stockings
* Reduced mobility
* Major surgery, prolonged hospitalization or pregnancy within 3 months of screening
* Major co-existing disease (e.g. malignancy; pulmonary disease; renal or hepatic insufficiency; serious skin disease/condition that may compromise the ability of the patient to comply with the compression protocol, etc.)
* Known allergic response to polidocanol or heparin, including history of heparin-induced thrombocytopenia, and/or multiple allergic reactions
* Current alcohol or drug abuse
* Pregnant or lactating women
* Women of childbearing potential not using effective contraception
* History of DVT, pulmonary embolism, or stroke
Breaks From Sedentary Behavior With Dual Tasks in Elderly

The aim of this project will be to compare the acute effects of breaks from sedentary behavior using dual-tasking on cerebral blood flow, vascular function, cognitive functions and blood pressure in elderly people. Participants will perform, in random order, three experimental sessions (control, break with dual-task and standard break (\[walk\]). All sessions will have a period of 4 hours in sedentary behavior. In the standard break session and in the break session with dual-task participants will take walking and dual-task breaks every 30 minutes, and in the control session they will remain seated without breaks. Before and after this period, cerebral blood flow, vascular function, cognitive functions and blood pressure will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* aged 60 years or over
* be physically independent based on the Katz Test
* have no history of heart attack
* not having suffered a stroke
* not have heart failure
* do not have joint problems that prevent them from carrying out experimental sessions
* do not have a history of neurodegenerative diseases
* obtain ≥ 26 points in the Montreal Cognitive Assessment (MoCA)
* are not involved in the practice of regular, systematic physical activity more than once a week over the last six months prior to the start of the study
* not be smokers and morbidly obese.
Genetic Epidemiology of CHD Risk Factors in Blacks

To determine the genetic epidemiology of coronary heart disease (CHD) risk factors in Blacks.

DESIGN NARRATIVE:

The study used two well defined African populations from Nigeria to determine the contribution of 14 polymorphic genes involved in lipid metabolism in determining quantitative lipoprotein-lipid and apolipoprotein levels as these are major risk factors for coronary heart disease. The study also investigated how differences in life styles and dietary habits modulate the genetic contribution of these quantitative risk factors. Phenotypes in the gene products of APOs A-IV, C-II, D, H, J and (a) were determined by IEF and SDS/immunoblotting. Genotypes at the B,E, AI-CIII- AIV cluster, lipoprotein lipase, hepatic lipase, LDL-receptor, and cholesterol ester transfer protein were determined by polymerase chain reaction protocols. The quantitative levels of total cholesterol, HDL-cholesterol and its subfractions, HDL2- and HDL3-cholesterol, triglycerides and LP(a) were used in the genetic analyses. Estimates of the effect of alleles at each of the candidate loci on quantitative lipoprotein-lipid levels employed the measured genotype approach. The effect of multisite haplotypes for RFLP at various loci, where applicable, was also estimated using the same method. The interaction of alleles at various independent loci in determining quantitative lipoprotein-lipid and apolipoprotein levels was estimated. In addition to the measurements of environmental effects, measurements were also made of the genotype-environmental interaction in determining quantitative risk factor traits.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Nebulized Dexmedetomidine or Lidocaine for Treatment of Post Dural Puncture Headache in Parturients Undergoing Elective Cesarean Section Under Spinal Anesthesia

Post-dural puncture headache (PDPH) is a well-recognized and potentially serious complication of subarachnoid block. While advancements in spinal needle design have reduced its incidence in recent years, PDPH still affects a notable percentage of post-partum patients undergoing spinal anaesthesia, with rates ranging from 0.5% to 2%. Factors such as female gender, pregnancy, young age, low body mass index, dilutional anemia, and the preference for neuraxial anaesthesia during caesarean section (CS) increase the vulnerability of obstetric patients to PDPH. Therefore, managing this complication is critically important in obstetric anaesthesia.

The exact cause of PDPH remains unclear, but there is substantial evidence suggesting that it stems from reduced cerebrospinal fluid (CSF) pressure due to continuous leakage through a dural tear, which exceeds the rate of CSF production. This imbalance can lead to PDPH, as even a modest loss of CSF volume (as little as 10%) can trigger traction on pain-sensitive intracranial structures when in an upright position, compounded by reflexive vasodilation.

Various treatment strategies have been proposed, typically including bed rest in a supine position, fluid therapy, analgesics, and medications such as sumatriptan and caffeine.

Dexmedetomidine (DEX) is a highly specific agonist of α2-adrenoreceptors known for inducing cooperative sedation, anxiolysis, and analgesia while minimizing respiratory depression. Additionally, it has been shown to mitigate the stress and inflammatory response triggered by surgical and anaesthetic procedures. Activation of α2-receptors in the substantia gelatinosa of the dorsal horn suppresses the firing of nociceptive neurons and inhibits the release of substance P. Furthermore, stimulation of these receptors in the locus coeruleus, a key modulator of nociceptive transmission, interrupts the transmission of pain signals, resulting in analgesia. Dexmedetomidine has been administered via intranasal and inhalational routes for various purposes, including premedication, sedation, and post-operative analgesia.

Lidocaine nebulized is a novel method used recently for PDPH. Intranasal lidocaine can offer sphenopalatine ganglion block which can facilitate acute pain reduction in PDPH.


Eligibility Criteria:
Inclusion Criteria:

* Post partum headache for parturient with elective CS under spinal anesthesia with visual analog score (VAS) ≥ 4 \[14\] and Lybecker classification score ≥ 2

Exclusion Criteria:

* Emergency caesarean section.
* Pregnancy induced hypertension
* Contraindications for sub-arachinoid block ( coagulopathy, infection )
* History of chronic headache, migraine, trigeminal neuralgia
* Refusal to participate
* History of cerebrovascular stroke
* BMI\> 35
* History of obstructive sleep apnea.
Integrating Supportive Care in Cystic Fibrosis

Individuals living with cystic fibrosis (CF) commonly report high symptom burden, poor quality of life, and additional psychosocial stressors; these burdens are particularly heightened in advanced stages of the disease. Although supportive care (aka palliative care) has been shown to improve many of these outcomes among patients with illnesses such as cancer, no clinical trials to date have tested the impact of supportive care for patients with CF. The purpose of this pilot randomized clinical trial study is to evaluate the feasibility, acceptability, and perceived effectiveness of an embedded supportive care intervention, whereby a supportive care specialist will be integrated within the usual care experience of patients with advanced CF. The investigators will enroll 50 patients with advanced CF, who will be equally randomized to receive this embedded supportive care intervention or usual care. Secondary measures include: patient quality of life, mood, coping style, satisfaction with care, and symptom burden. This study will provide preliminary data to support the development of a larger, definitive, Phase III randomized clinical trial.

As described above.

Eligibility Criteria:
Inclusion Criteria:

* Ability to comprehend English
* Advanced CF

(Any of the following criteria will be indicative of "Advanced CF")

* Baseline supplemental oxygen requirement
* FEV1 ≤ 50%
* Baseline non-invasive mechanical ventilation requirement
* ≥ 2 hospitalizations in the past 12 months for respiratory complications related to CF

Exclusion Criteria:

* Prisoners
* Females who are pregnant
* Prior receipt of specialist SC services
* Cognitive impairments
* Patients younger than 18 years of age
Safety and Efficacy of Endocuff-assisted Colonoscopy for Adenoma Detection.

This study investigated the impact of Endocuff-assisted colonoscopy on the adenoma detection rate at colonoscopy. This study involved patients undergoing elective screening or surveillance colonoscopy.

Patients were randomized to undergo Endocuff or regular, high-definition colonoscopy before undergoing a second colonoscopy by the alternate method. The primary outcome measure was the detection rate for adenomas between patients who underwent Endocuff first and patients who underwent regular colonoscopy first.


Eligibility Criteria:
Inclusion Criteria:

* Colonoscopy: Screening , Surveillance, Diagnostic

Exclusion Criteria:

* Pregnancy
* age\<18 years
* age \> 80 years
* known colonic strictures
* chronic inflammatory bowel disease
* active inflammation
Primary Chemotherapy With Anthracycline Followed by Nab-paclitaxel and Trastuzumab

The purpose of this study is to evaluate the efficacy in terms of the pathological complete response (pCR) rate and the efficacy to preoperative administration of Anthracycline-based regimen followed by Nab-paclitaxel and Trastuzumab in patients with HER2 positive operable breast cancer.

Four cycles of anthracycline-based regimen followed by four cycles of Nab-paclitaxel and Trastuzumab are administrated.

Anthracycline-based regimen (d1, q3w):

EC (Epirubicin 90mg/m2 and Cyclophosphamide 600mg/m2) AC (Doxorubicin 60mg/m2 and Cyclophosphamide 600mg/m2) FEC (Fluorouracil 500mg/m2, Epirubicin 100mg/m2 and Cyclophosphamide 500mg/m2)

Nab-paclitaxel 260mg/m2 (d1, q3w)

Trastuzumab (d1, q3w) is given at a dose of 8 mg/kg IV on day 1 of the first treatment cycle over 90 min, and subsequently given at a dose of 6 mg/kg over 30 min.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed invasive breast cancer
* T1c-3 N0-2a
* Confirmed of hormonal receptor status
* HER2 positive confirmed by IHC 3+ or FISH+
* LVEF \> 50% by echocardiogram or MUGA
* Adequate EKG
* No prior treatment for breast cancer
* PS 0-1
* Required baseline laboratory data WBC \> 4,000/mm3 and Neut \> 2,000/mm3 PLT \> 100,000/mm3 Hb \> 9.0g/dl AST and ALT \< ULNx2.5 T-Bil \< 1.5mg/dl Serum creatinin \< 1.5mg/dl
* Written informed consent

Exclusion Criteria:

* With history of hypersensitivity reaction for important drug in this study
* With history of invasive breast cancer
* Bilateral invasive breast cancer
* Patients with medical conditions that renders them intolerant to primary chemotherapy and related treatment, including infection, diarrhea, intestinal paralysis, severe Diabetes Mellitus
* Positive for HBs antigen and with history of HVB
* With history of congestive heart failure, uncontrolled or symptomatic angina pectoris, arrhythmia or myocardial infarction, poorly controlled hypertension
* With severe edema
* With severe peripheral neuropathy
* With severe psychiatric disorder
* Pregnant or nursing women
* Cases who physician judged improper to entry this trial
Environment and Childhood Project Based on a Multicentric Mother-child Cohort of Spain

INMA - INfancia y Medio Ambiente \[Environment and Childhood\] Project is a research network of several Spanish groups that created a project with the aim to study the paper of the more relevant environmental pollutants in the air, water and diet during the pregnancy and beginning of life, and their effects in the growth and development.

The INMA Project is based on the experience acquired by groups that studied several cohorts with different objectives: the cohort of Riera d'Ebre (n=102), an area with high levels of organochlorine compounds and mercury, evaluated the relationship between these exposures and the neurological development of the children; the cohort of Menorca (n=492), studied the relationship between the early exposure to irritating of the air and allergens with the development of allergy and asthma; and the cohort of Granada (n=668), that studied the incidence of reproductive disorders in men in relation to the exposure to endocrine disruptors.

Based on the experience of these previous cohorts, other 4 new cohorts were designed to evaluate the impact of environmental exposures in children's health: Valencia (n=787), Sabadell (n=622), Asturias (n=485) and Gipuzkoa (n=612), that followed the same protocol. The population of the study are pregnant women of the general population who lived in each area of study (Ribera d' Ebre, Menorca, Granada, Valencia, Sabadell, Asturias, and Gipuzkoa and their children. Each cohort had different periods and types from recruitment. In the cohorts of Ribera d'Ebre and Granada, the mothers were recruited during the admission to the hospital at the moment of the childbirth. In Ribera d'Ebre, the recruitment was between March 1997 and December 1999, whereas in Granada it was between October 2000 and July 2002. In Menorca, all the eligible women who went to the prenatal visit in some of the sanitary centres of the island (private or public) were invited to participate in the study, and the recruitment lasted a year starting in July 1997. In the 4 new cohorts the recruitment took place during the first prenatal visit (between weeks 10 and 13 of gestation) in the public hospital of reference or in the health centre of the area. The periods of recruitment went from February 2004 to June 2005 in Valencia, from July 2004 to July 2006 and May 2007 to July 2007 (there was an additional round of recruitment) in Sabadell, from May 2004 to June 2007 in Asturias, and from April 2006 to January 2008 in Gipuzkoa.


Eligibility Criteria:
Inclusion Criteria:

To belong to the study area (specific of each cohort). To be minimum 16 years. To have a unique pregnancy To give birth in the reference hospital

Exclusion Criteria:

To have followed any program of assisted reproduction To have communication problems