cyrilzakka/clinical-trials huggingface dataset:
Fetal Ebstein Anomaly and Tricuspid Valve Dysplasia Registry

Ebstein anomaly and tricuspid valve dysplasia (EA/TVD) are rare congenital tricuspid valve malformations that carry among the highest mortality of all congenital heart disease diagnosed in utero. Despite the high mortality associated with severe EA/TVD in the fetus, it has only been studied retrospectively. By prospectively enrolling a cohort across multiple centers, many questions may be answered in the perinatal period and beyond. The registry will allow us to understand perinatal and postnatal decision-making in this complex group of patients across centers.


Eligibility Criteria:
Inclusion Criteria:

1. Mothers of fetuses (ages 14-54) diagnosed with EA/TVD of any severity with normal segmental anatomy (AV and VA concordance)

   1. Mothers may be enrolled at any gestational age, up to the day of pregnancy outcome (elective termination of pregnancy, demise, or live-birth)
   2. Singletons, twins or higher order multiples may be included
2. Consent obtained at a participating site

Exclusion Criteria:

1. Mothers of fetuses diagnosed with EA/TVD in the context of abnormal segmental anatomy (AV and/or VA discordance) or other lesions, such as congenitally corrected transposition of the great arteries or pulmonary atresia with intact ventricular septum
2. Unable or unwilling to provide consent
Gender Dependent Difference in Lipemia After 6 x OFTT in Young Healthy Subjects

The investigators wanted to study the postprandial lipemia after six oral fat tolerance test with varying amounts of saturated fat in young healthy subjects.

With six different types of butter added in random order to potatoes the investigators studied postprandial lipemia (PPL), lipoprotein, glucose, and insulin increments for eight hours in 14 young, lean, healthy students, seven of each gender.

The six, isocaloric meals contained 55.1 g carbohydrate, 5.8 g protein, 82.3 g fat, and 4177 kJ. The potatoes, without skin, were boiled in 20 minutes in excess of water with 5 g of salt added, were blended in 4 minutes and served hot. The meals were ingested over 10 minutes, with 250 ml tap water. The following 8 hours the participants stayed at the clinic to watch television, read or take a short walk of 10 minutes.

Blood samples were drawn at -15, 0, 30, 60, 90,120,180,240,300,360, 420 and 480 minutes after the meals and processed after each drawing. After blood collection, plasma was immediately separated by centrifugation at 3000 rpm for 10 minutes at 4°C.

The area under the curve (AUC) were determined for TG, HDL, LDL, total cholesterol, FFA, insulin, and glucose concentrations by the trapezoid method. Multiple regression was performed to adjust for age, gender, meals, and BMI to the variance of postprandial responses. The difference between meals were tested with ANOVA. If p\<0.05 in ANOVA, post-hoc-testing with Student-Newman-Keul's test was performed to identify, which meal was significantly different from the other, and to minimize the risk of error by multiple testing.

Eligibility Criteria:
Inclusion Criteria:

* Accept healthy volunteers

Exclusion Criteria:

* hypercholesterolemia,
* hypertension,
* abuse of drugs or alcohol,
* known kidney, liver, heart and metabolic disease
* hormonal therapies including oral contraceptives
Intravenous Magnesium Sulfate in Aneurysmal Subarachnoid Haemorrhage (IMASH)

The IMASH trial is a simple, randomized, double-blinded, placebo-controlled, multi-center trial to answer the question: "Does intravenous magnesium sulfate improve clinical outcome after aneurysmal subarachnoid hemorrhage?"

Vasospasm worsen outcome in patients with aneurysmal subarachnoid hemorrhage (ASAH).

Magnesium is known to dilate cerebral arteries and to block N-methyl-D-aspartate receptors in the injured neurons.

Intravenous magnesium may prevent vasospasm after subarachnoid hemorrhage and may protect neurons against damage during established vasospasm.

The IMASH trial is a randomized, placebo-controlled, double-blinded, multi-center trial to evaluate the effect that intravenous magnesium sulfate infusion on the clinical outcome of patients with aneurysmal subarachnoid haemorrhage.

Methods:

After obtaining randomisation code:

* Start MgSO4 20 mmol over 30 minutes, followed by infusion of 80 mmol/day or equivalent volume of saline within 48 h after onset of symptom,
* Study drug to be infused for 14 days from the day of hemorrhage (regarded as day 0).
* Measure plasma magnesium concentration daily and perform transcranial Doppler to monitor blood flow velocities of both middle cerebral arteries and extracranial segment of the internal carotid arteries.
* Plasma magnesium concentration in the IV MgSO4 group should be raised to 2.0-2.5 mmol/L or twice the serum baseline level. Patients that are randomized to saline infusion will only have their magnesium levels normalized if there is a clinical indication to do so.

Outcome assessment Primary outcome: Extended Glasgow Outcome Scale at six months Secondary outcome: Incidence of clinical vasospasm, Barthel Index; modified Rankin score, modified National Institute of Health Stroke Score, MCA velocities, other major complications

Study duration:

6 years with a refined sample size of 340 after analysis of pilot study data; with planned interim analysis.

Eligibility Criteria:
Inclusion Criteria:

* ASAH (as indicated by CT scan or lumbar puncture and an intracranial aneurysm confirmed by computer tomographic or conventional angiography)
* Within 48 hrs of ictus (hemorrhage event)

Exclusion Criteria:

* Pregnancy
* Major renal, hepatic or pulmonary disease
* Major cardiac disease or recent myocardial infarct (\< 6 months)
* Age less than 18 years
* Moribund condition on admission (defined as a patient that is in such a poor clinical condition that further active neurosurgical management would not be anticipated)
The Pathogenesis of Chronic Diarrhoea After Treatment for Cancer in Cecum and the Ascending Colon

Many patients suffer from chronic diarrhoea after surgical treatment for cancer in the right side of the colon.

The investigators' main hypothesis is that colon cancer patients with chronic diarrhoea have a higher risk of bile acid malabsorption compared with colon cancer patients without diarrhoea.

The investigators also expect that a part of the cases of bile acid malabsorption is caused by underlying bacterial overgrowth in the small bowel.

The investigators assume that patients with severe bile acid malabsorption have a lower value of FGF19 in the blood compared to patients with moderate or none bile acid malabsorption.

Furthermore, it is assumed that patients with chronic diarrhoea and documented bile acid malabsorption after surgical treatment for right-sided colon cancer will get improved bowel function when treated with a bile acid binder, or antibiotics in case of bacterial overgrowth.

Patients with chronic diarrhoea after surgical treatment of right-sided colon cancer will be compared to patients without diarrhoea after right-sided colon cancer treatment.

All patients will be asked to answer a short questionnaire regarding bowel function, and they will all have standard blood tests taken to exclude non-cancer related causes of diarrhoea. Besides these standard tests, the value of FGF19 will be measured in a blood sample from the fasting participants. All participants will undergo SeHCAT scan to determine the presence of bile acid malabsorption among right-sided colon cancer patients with and without diarrhoea. In addition, a glucose breath test will be performed to examine, if the patients have small intestinal bacterial overgrowth.

Patients with a positive glucose breath test, and thus bacterial overgrowth, will be treated with antibiotics, followed by another SeHCAT scan, glucose breath test, and measurement of gastrointestinal transit time. In addition, they will be asked to complete the questionnaire regarding bowel function again. All cases with an abnormal SeHCAT scan will be treated with a bile acid binder, and the patients will be asked to complete the questionnaire one more time, and the GITT measurement will be repeated.

Eligibility Criteria:
Inclusion Criteria:

* Primary adenocarcinoma in cecum or the ascending colon
* Right-sided hemicolectomy
* Understanding, speaking and reading Danish

Exclusion Criteria:

* Previous major gastrointestinal, urological or gynaecological surgery or oncological treatment
* Radiation therapy
* Recurrence of colon cancer
* Metastasis
* Permanent stoma
* Pregnancy
* Reduced cognitive level that makes it plausible that the patient do not understand the study or is not capable of participation
Reminiscence Therapy in Individuals With Dementia

This research will be carried out with the aim of determining the effect of reminiscence therapy applied to individuals with dementia on cognitive functions, anxiety, depression and activities of daily living.

The research will be conducted with a pre-test post-test single group, quasi-experimental research design.

Dementia; It is a disease that requires intensive use of health services, has a high care burden, and has medical, social, psychological and economic burdens for the patient, family and society. Dementia is characterized by many disorders in cognitive functions, especially memory, thought and social skills. Progressive disorders in cognitive functions cause behavioral changes, decrease in activities of daily living, and neuropsychiatric symptoms such as anxiety and depression.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with mild to moderate dementia according to DSM-5 criteria (whether individuals have an official diagnosis of neurocognitive disorder according to DSM-5 criteria and their medical diagnosis will be verified from the health records at the institution),
* Getting a score between 13-23 for the educated (literate) and 10-23 for the uneducated (illiterate) on the mini mental state examination,
* Being 65 years of age or older,
* Being able to communicate,
* No vision or hearing problems,
* Consent to participate in the research.

Exclusion Criteria:

* Getting a score below 13 and above 23 for the educated (literate) and below 10 and above 23 for the uneducated (illiterate) from the mini mental state examination,
* Having an acute illness that prevents participation in intervention sessions,
* Having serious sensory and physical limitations that prevent participation,
* Having severe neuropsychiatric symptoms (agitation, psychosis, apathy, uncontrolled delirium, etc.),
* Having a traumatic life history,
* Having recently participated in a similar program.
Sealing of Initial Occlusal Caries Using Fissure Sealants

The purpose of this study is to compare the performance of newly introduced bioactive resin based pits and fissure sealant versus fluoride releasing resin based pits and fissure sealant in initial carious lesions of fissures in posterior molars in patients at risk of caries. Visual tactile examination and VistaCAM will be used for evaluation.

SmartCap™ Technology, which is used in the novel bioactive fissure sealant, is based on proprietary semi-permeable resin microcapsules. The rechargeable SmartCap microcapsules in BioCoat are packed with ionic fluoride, calcium, and phosphate solutions that diffuse in and out of the sealant. It is hypothesized that fluoride uptake is increased in the presence of calcium and phosphate ions.

With little evidence-based information in the literature about using bioactive fissure sealants to seal initial carious lesions, it was determined that a randomized controlled trial would be beneficial in testing the null hypothesis that bioactive resin pits and fissure sealant will have the same clinical performance as fluoride releasing resin-based pits and fissure sealant in fissures with initial caries.

Eligibility Criteria:
Inclusion Criteria:

* Patients with bilateral initial carious fissures in molars showing no signs of caries.
* Co-operative patients approving to participate in the trial.

Exclusion Criteria:

* Sound fissures.
* Pregnancy.
* Disabilities.
* Systemic disease or severe medical complications.
* Rampant caries.
* Heavy smoking.
* Xerostomia.
* Lack of compliance.
* Evidence of severe bruxism, clenching, or tempromandibular joint disorders.
Upper Limb Functional Testing in Athletes

The aim of this study is to elaborate sports-specific normative data for different upper limb functional tests.

About 250 sportspeople, aged between 14 and 35 years, and practicing an upper limb sport, will be recruited. They will performed some of the following tests, based on the sport they practice :

* Upper Quarter Y Balance Test
* Athletic Shoulder Test
* Single Arm Medicine Ball Throw
* Countermovement push-ups
* Closed Kinetic Chain Upper Extremity Stability Test
* Upper Limb Rotation Test
* Posterior Shoulder Endurance Test
* Seated Shot Put Test


Eligibility Criteria:
Inclusion Criteria:

* To practice an upper limb sport, at least 5 or 6 hours a week

Exclusion Criteria:

* Shoulder pain, injury or surgery during the last 6 months
Effect of Mediterranean and Hypolipemic Reduction Diet in Obese Patients

The purpose of this study is to evaluate the combined effect of physical activity and adherence to Mediterranean diet or Hypolipemic Reduction diet on parameters of oxidative stress in obese patients enrolled in the weight management reduction program.


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 30 kg/m2

Exclusion Criteria:

* newly diagnosed diabetes, hypertension or cardiovascular disease
* change in antihypertensive therapy and antidiabetic therapy in the period of 3 months prior to the commencement of the study
* insulin therapy
* alcohol consumption \>500 g of alcohol/week in the last year
* pregnancy or breast feeding
* use of drugs affecting weight control (eg. weight loss medication or systemic glucocorticoids)
Accelerating Motor Recovering in Patients With SMA Syndrome After Glioma Surgery by Using nrTMS

The goal of this randomized clinical controlled trial is to learn about whether neuro-navigation repetitive transcranial magnetic stimulation (nrTMS) was useful to accelerate the recovery in patients with SMA syndrome after glioma resection. The main questions aim to answer:

* Question 1: Whether the nrTMS was useful to accelerate the recovery of motor function back to the preoperative status in participants with SMA syndrome after glioma resection.
* Question 2: Whether the nrTMS was useful to improve postoperative motor function in participants with SMA syndrome after glioma resection.

Participants will continue to receive nrTMS treatment or nrTMS sham-treatment for 7 times on the 8th day after glioma resection to determine whether the TMS was helpful for exercise rehabilitation. The investigator will evaluate the effects of nrTMS treatment through the ratio of recovery of motor function and the time that was from the participants suffering SMA syndrome to totally recover the motor function to the status of motor function in pre-operation.

This study will use the 8-coil (Magstem, England, No.4150) and sham 8-coil (Magstem, England) The criteria of enrolled patients are： A. Inclusion time: from April 01 2023 to March 31 2025 (including the current month); B. Inpatients in neurosurgery oncology wards of Beijing Tiantan Hospital; C. Right-handed, age: 25-55 years old, tumor located in SMA, no previous treatment history of nervous system disease; D. The patient received wake-up surgery and applied direct cortical electrical stimulation during the operation to determine the location of the motor area; E. Postoperative pathology was low grade glioma; F. Can accept nrTMS rehabilitation treatment.

The excluding criteria are:

A. The tumor grows across the midline to the opposite side; B. When collecting rs-fMRI data, head movement exceeds 1mm and head deflection exceeds 1 °; C. The patient did not have SMA syndrome after operation; D. Vulnerable or special groups and protective measures, such as pregnant women.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients in neurosurgery oncology wards of Beijing Tiantan Hospital
* Right-handed, age: 25-55 years old
* Tumor located in supplementary motor area
* No previous treatment history of central nervous system disease
* The patient received awaken craniotomy
* Pathological diagnosis is low grade glioma
* Volunteer to accept nrTMS treatment

Exclusion Criteria:

* The tumor grows across the midline to the opposite side
* Regarding rs-fMRI data, head movement exceeds 1mm and head deflection exceeds 1 °
* The patient did not have SMA syndrome after operation
* Vulnerable or special groups and protective measures, such as pregnant women
Evaluation of Tumor Response to Ipilimumab in the Treatment of Melanoma With Brain Metastases

To assess the response of melanoma with brain metastases to ipilimumab treatment while maintaining acceptable tolerability.


Eligibility Criteria:
Key inclusion criteria

* Histologically confirmed malignant melanoma
* At least 1 measurable index brain metastasis \>0.5 cm and no larger than 3 cm in diameter that had not been previously irradiated, and/or 2 measurable lesions \>0.3 cm visible on contrast magnetic resonance
* Index brain lesion must have resolved consequences of prior therapy that could have confounded attribution of tumor response including edema and hemorrhage
* Participants in ipilimumab monotherapy arm (including the first 21 who were enrolled in Stage 1) were to be free of neurologic symptoms related to metastatic brain lesions and must not have required or received systemic corticosteroid therapy in the 10 days prior to beginning ipilimumab therapy
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Required values for initial laboratory tests:

  * White blood cell count ≥2000/μL
  * Absolute neutrophil count ≥1000/μL
  * Platelets ≥100\*10\^3/μL
  * Hemoglobin level ≥9 g/dL (may have been transfused)
  * Aspartate aminotransferase/alanine aminotransferase (AST/ALT) level ≤2.5\*ULN for participants without liver metastasis
  * AST/ALT level ≤5\*ULN for those with liver metastasis
  * Bilirubin level ≤2\*ULN (except participants with Gilbert's Syndrome, who must have had a total bilirubin level less than 3.0 mg/dL)
* Age 16 years and older
* Males and females
* Women of childbearing potential (WOBP) must be using an adequate method of contraception to avoid pregnancy throughout the study (and for up to 26 weeks after the last dose of investigational product) in such a manner that the risk of pregnancy is minimized. WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or is not postmenopausal.

Key exclusion criteria

* History of carcinomatous meningitis, with prior stereotactic or highly conformal radiotherapy and/or whole brain irradiation within 14 days before the first dose of ipilimumab, and documented history of autoimmune disease
* Prior stereotactic or highly conformal radiotherapy and/or whole brain irradiation within 14 days prior to start of ipilimumab dosing for this study. Note the stereotactic radiotherapy field must not have included the brain index lesion or the lesion must have been detected and confirmed to be active and progressing after receiving whole brain irradiation.
A Relative Bioavailability Study Measuring the Extent and Rate of Absorption of Different Tablet Formulations of AZD1656 in Type 2 Diabetes Mellitus (T2DM) Patients

The purpose of this study is to assess the relative bioavailability by measuring the extent and rate of absorption of different tablet formulations of AZD1656 in T2DM patients.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated, written informed consent prior to any study specific procedures.
* Males or females of non-childbearing potential (post-menopausal, and/or have undergone hysterectomy and/or bilateral oophorectomy or salpingectomy/ tubal ligation) aged ≥18 years. Females will be defined as post-menopausal if last menstruation period was \>1 year ago and serum follicle stimulating hormone (FSH) is within the post-menopausal range, or if age \>50 years and with last menstruation period \>2 years ago.
* A confirmed clinical diagnosis of T2DM for at least 1 year, treated with metformin as a single treatment or in combination with one other oral anti-diabetic (ie, DPPIV inhibitor or SU) for at least 2 months prior to screening. Doses of anti-diabetic treatment should have been stable for at least 1 month prior to screening.
* Treatment with at least 1000mg of Metformin for 2 months and being stable on the Metformin Therapy for 1 month
* Hb A1c \>6.5% (international standard) at enrolment.
* Body mass index (BMI) between ≥19 and ≤42 kg/m2.

Exclusion Criteria:

* Clinically significant illness or clinically relevant trauma, as judged by the Investigator, within 2 weeks prior to the first administration of AZD1656
* Participation in another clinical study during the 30 days prior to screening or intake of another investigational drug within 30 days (or at least 5 x t1/2 of the drug) prior to the first administration of AZD1656.
* History of, or ongoing, ischemic heart disease or heart failure. Stroke, transitory ischemic attack, or symptomatic peripheral arterial disease within the last 6 months.
* Clinically significant abnormalities in ECG, clinical chemistry, hematology or urinalysis results.
* Positive test for Hepatitis B surface antigen (HBsAg) or antibodies to human immunodeficiency virus (HIV) or Hepatitis C virus.
Effects of a Liquid Meal and Gut Hormones (GIP and GLP-2) on Bone Remodeling in Participants With Hypoparathyroidism.

Hypoparathyroidism (hypoPT) is characterized by low levels of PTH.

In this study we will test the effects of a liquid meal on the bone remodeling in participants with hypoparathyroidism. Furthermore, we will test the effects of the gut hormones GIP and GLP-2.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 76
* Hypoparathyroidism

Exclusion Criteria:

* Diabetes
* Disease in the gastrointestinal tract
* Antiosteoporotic drug
* Long term steroid treatment (within the last 12 months)
* Pregnancy
Phosphatidylcholine (LT-02) for Induction of Remission in Ulcerative Colitis

The purpose of this study is to compare two different dosing regimens of phosphatidylcholine versus placebo for the induction of remission in ulcerative colitis patients non-responsive to standard mesalamine treatment.


Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of ulcerative colitis
* Active ulcerative colitis disease extent ≥ 15 cm
* Active disease despite treatment with mesalamine

Exclusion Criteria:

* Crohn's disease, indeterminate colitis, ischemic colitis, radiation colitis, microscopic colitis, diverticular disease associated colitis,
* Toxic megacolon or fulminant colitis
* Colon resection
* Evidence of infectious colitis
* Celiac disease
* Bleeding hemorrhoids
* History or presence of ischemic heart disease, myocardial infarction, peripheral arterial disease, ischemic stroke, or transient ischemic attack
* Any severe concomitant renal, endocrine, or psychiatric disorder
* Any relevant known systemic disease
* History of cancer in the last five years
* Abnormal hepatic function or liver cirrhosis
* Abnormal HbA1c at screening visit
* Patients with known hypersensitivity to soy
* Known intolerance/hypersensitivity to Investigational Medicinal Product (IMP)
* Treatment with steroids/methotrexate/Tumor necrosis factor-alpha-antagonists/azathioprine/ 6-mercaptopurine/anti-integrin/coumarins
* Treatment with other investigational drug
* Existing or intended pregnancy or breast-feeding