cyrilzakka/clinical-trials huggingface dataset:
Brain Imaging of Psychotherapy for Posttraumatic Stress Disorder (PTSD)

The investigators are seeking people who have been exposed to a traumatic event in the past and have symptoms of posttraumatic stress disorder (PTSD) currently. A person with PTSD may feel significant distress when reminded of a traumatic event or feel depressed, anxious or jumpy.

As a part of this study, participants will receive brain MRIs and office assessments before and after psychotherapy. The investigators provide the gold-standard psychotherapy for PTSD, "Prolonged Exposure", free of charge; additionally participants are compensated for their time during assessment procedures. This study is exploring the brain circuitry involved in improvement in response to psychotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. age between 18 and 60 years;
2. fMRI scanning eligibility, including no evidence of any form of metal embedded in the body (e.g., metal wires, nuts, bolts, screws, plates, sutures), as these produce artifacts when brain imaging;
3. not currently involved in an exposure-based psychotherapy, in order to be able to measure and interpret the effects of PE on PTSD;
4. must comprehend English well and show non-impaired intellectual abilities to ensure adequate comprehension of the fMRI task instructions and PE treatment;
5. no history of neurological or cardiovascular disorders, brain surgery, electroconvulsive or radiation treatment, brain hemorrhage or tumor, stroke, seizures or epilepsy, diabetes, hypo- or hyperthyroidism, head trauma with loss of consciousness greater than thirty minutes;
6. no regular use of benzodiazepine, opiate, thyroid, anticonvulsant or antipsychotic medications. Patients on stable doses of antidepressant medications will be allowed. Patients for whom antidepressant dosing is being actively titrated will be required to be on a stable dose for 1 month prior to inclusion in the study.

Exclusion Criteria:

* Any contraindication to being scanned in the 3T or 1.5T scanners at the Lucas Center or CNI such as having a pacemaker or implanted device that has not been cleared for scanning at the Lucas Center or CNI.
* Participants will be excluded from the study if there is any lifetime evidence of psychosis, mania, hypomania, or bipolar disorders. Other axis I comorbidities will not be a cause for exclusion.

In addition, subjects will be excluded if they have a significant CNS neurological condition such as stroke, seizure, tumor, hemorrhage, multiple sclerosis, etc.

Patients who have current substance dependence will be excluded from the study. A recent diagnosis of substance abuse is allowable, however, as long as subjects have been abstinent for greater than three months.

* Subjects will be excluded if they are currently in an exposure-based psychotherapy for PTSD.
Study to Evaluate the Efficacy of HepaStem in Urea Cycle Disorders Paediatric Patients (HEP002)

The aim of the study is to assess the efficacy of HepaStem treatment in paediatric patients suffering from urea cycle disorders.


Eligibility Criteria:
Main Inclusion Criteria:

* Paediatric patients \< 12 years prior to infusion
* Patient presents with UCD
* Patient shows patency of the portal vein and branches, with normal flow velocity as confirmed by Doppler US and accessibility of the portal vein and /or affluants.

Main Exclusion Criteria:

* Patient has mild disease severity, easily controlled under standard of care therapy, with no recurrent metabolic crises.
* Patient is registered on a liver transplant waiting list or is scheduled for living donor liver transplantation before the end of the study.
* Patient presents acute liver failure.
* Patient presents clinical or radiological evidence of liver cirrhosis.
* Patient presents or has a history of hepatic or extrahepatic malignancy.
* Patient has a known clinically significant cardiac malformation.
* Patient has a personal history of venous thrombosis, or has a clinically significant abnormal value for protein S, protein C, anti-thrombin III, and /or activated Protein C Resistance (aPCR) at screening. In case of known family history, a complete coagulation work-up should be performed. In all above described cases, results need to be discussed with PB before enrolling the patient in the study.
* Patient had or has a renal insufficiency treated by dialysis.
Neurostimulation in Pudendal Nerve Block

The purpose of this study is to check whether the success rate of blind pudendal nerve block in penile surgery can be optimized by the search for a motor response during neurostimulation.


Eligibility Criteria:
Inclusion Criteria:

* Children scheduled for elective penile surgery (hypospadias / circumcision)

Non-inclusion Criteria:

* Association to further peripheral nerve blocks required
Community Salt Testing and Relation of Iodine Intake to Visual Information Processing of Ethiopian Infants

This study evaluated efficacy of iodized salt for mothers and their six-month-old infants' thyroid hormones and visual information processing. Half of the participants received 450 g iodized salt for the household each week, while the other half received 225 ug iodine daily as a potassium iodide capsule.

Iodine is essential for the synthesis of thyroid hormones, and thyroid hormones regulate the metabolic processes of most cells and play important roles in human growth and development. Iodine deficiency disorders can have serious consequences on brain and physical development. In neonates iodine deficiency and hence insufficient supply of thyroid hormones could cause neonatal goiter, neonatal hypothyroidism, and endemic mental retardation.

Iodine deficiency disorders can be prevented and controlled by providing iodine and iodine can be provided in different ways. However, the United Nations Children's Fund and the World Health Organization jointly recommended salt iodization where iodized salt is accessible. Iodized salt is a safe, cost effective and sustainable strategy to ensure sufficient intake of iodine by all individuals and to improve maternal and infant health. However, although the effect of iodine on human health is well established efficacy of iodized salt has not been studied.

Eligibility Criteria:
Inclusion Criteria:

* The women must be lactating and must have an infant less than or equal to one week old.
* Mothers had to volunteer to participate in the study.

Exclusion Criteria:

* Any hyperthyroidism symptoms manifested by nervousness, anxiety, heart palpitations, or rapid pulse.
* If infants had fever, cough or severe (\>3/day) diarrhea
* Any allergic reaction such as acne, weakness, or foul breath
Evaluating the Effectiveness of Axiostat Hemostatic Dressing Material Versus Conventional Method of Hemostasis and Healing of Extraction Wounds in Patients on Oral Anti-Platelet Drugs - A Comparative Study

The rationale of this study was to evaluate the efficacy of Axiostat hemostatic dental dressing in achieving hemostasis post-extraction and determining its effect on pain and healing of the extraction wound, compared to control, i.e. conventional method of extraction in patients on oral anti-platelet therapy.


Eligibility Criteria:
Inclusion criteria

* Patients undergoing multiple tooth extractions aged b/w 35- 70 years and with INR values ≤ 3.5 (1-3.5)
* If present, sugar level should be under control

Exclusion criteria

* Patients undergoing a single tooth or multiple extractions in same quadrant; and those with an allergy to seafood.
Signaling Mechanisms and Vascular Function in Patients With Diabetes Mellitus

The purpose of the study is to learn how blood vessel function is altered by diabetes. We are studying an investigational drug, Ebselen, to see if it can improve the ability of blood vessels to relax (widen).

A major cause of death and disability in patients with diabetes mellitus is atherosclerosis. Endothelial dysfunction is an important, if not primary, factor in atherogenesis. Nitric oxide is an important substance made and released by the endothelium. Many prior studies in animals and humans have shown that the ability of the blood vessel to dilate is impaired in diabetes. This process of vasodilation is mediated by a substance, nitric oxide, which is thought to be highly susceptible to destruction by oxidant molecules. In previous studies, we found that acute administration of the antioxidant, vitamin C, improves endothelium-dependent vasodilation in blood vessels of patients with type 1 and type 2 diabetes. This suggests that by scavenging oxidants, such as superoxide, vitamin C may reduce the destruction of nitric oxide and thereby preserve endothelial function. Additional mechanisms, including activation of a substance called protein kinase C, and oxidant stress from excess soluble peroxides may be present in diabetes and interact with oxidant stress to cause endothelial dysfunction in patients with diabetes. Accordingly, we would like to study both of these mechanisms to determine their contribution to endothelial dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with diabetes mellitus will be eligible if they are receiving dietary treatment for hyperglycemia, sulfonylureas, metformin or insulin

Exclusion Criteria:

* Any diabetic subject with a HgbA1C level of \<7% or \>11%
* Evidence of atherosclerosis
* symptoms of angina
* symptoms of claudication
* symptoms of cerebrovascular ischemia
* findings of arterial occlusive disease, as would be suggested by decreased pulses, asymmetric blood pressure, bruits or reduced limb pressure measurements
* hypertension defined as a systolic blood pressure \> = 150 mmHg and a diastolic blood pressure \>= 95 mmHg; (allowable blood pressure medications for diabetic subjects include calcium channel blockers, alpha and beta adrenergic blockers, and diuretics)
* hypercholesterolemia, defined as total cholesterol levels greater than 75th percentile for age and sex and LDL cholesterol levels \>130mg/dL.
* renal insufficiency (serum creatinine \>1.5 mg/dL for men; \>1.2 mg/dL for women)
* hepatic dysfunction defined as liver enzyme abnormalities \> two times the upper limit of normal
* chronic pulmonary disease
* congestive heart failure
* pregnancy (or subjects planning to become pregnant);
* history of cigarette smoking within the last five years;
* history of clinically significant coronary artery or cerebrovascular disease (defined as MI or stroke within 6 months, or presence of unstable angina)

  * use of any, vasoactive, cardioactive, or non-steroidal anti-inflammatory medications within 24 hours of vascular testing visits
Early Detection of and Intervention Towards Chronic Diseases Among Individuals Without Formal Education

In this randomized controlled study it is investigated if a proactive action by the general practitioner offering individuals without formal education a preventive health check will lead to a larger number of diagnoses in form of chronic obstructive pulmonary disease, cardiovascular diseases, and diabetes among participants in the intervention group compared to the control group. Furthermore it will be investigated if the proactive action by the general practitioner will be associated with a higher smoking cessation rate at 12 month follow-up.

The study will be conducted at Vesterbro and Amager in Copenhagen, Denmark, and general practitioners with a medical practice in this area will be invited to enter the study. From the patient lists of the participating general practitioners all persons aged 45-64 years will be identified and baseline questionnaires will be mailed to these persons.

The questionnaire information will be entered electronically into the general practitioners electronic chart system using the Danish Quality Unit of General Practice (DAK-E) system. Thus, the questionnaire information will provide the general practitioners with information in the electronic form on health behavior, symptoms and socioeconomic information on all his patients in this age group that would not normally have access to in a systematic way.

Persons who answer the baseline questionnaire and who do not have any formal education will randomly be divided into two groups - one intervention group and one control group.

All persons allocated to the intervention group will receive a personal invitation to an appointed health check from their general practitioner. The health check at the general practitioner includes measurement of weight, height, hip and waist circumference, blood pressure, lung function, blood sugar, total cholesterol, and thyroidal status.

Participants with abnormal screens at the health check will, depending of the severity, either receive the offer of the referral to the municipality health center for a lifestyle change program and/or follow the procedures for diagnostics and treatment. For individuals with abnormal screens or health behavior amenable to intervention at the first health check an additional health check will be scheduled six months after the first health check.

Persons allocated to the control group will receive a baseline questionnaire and other than that follow normal procedure in general practice.

At 12 month follow-up questionnaires will be send out to all participants at the intervention group as well as the control group.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be 45-64 years old with no formal education beyond secondary school
* Participants must live in Copenhagen
* Participants' general practitioner must be participating in the study

Exclusion Criteria:

-
Biodistribution of [11C]Acetoacetate/[18F]Fluorodeoxyglucose in Subjects With Risk Factors for Alzheimer's Disease

This is a single center imaging study that will recruit 60 participants who are enrolled in the Effect of a Ketogenic Diet on Alzheimer's Disease Biomarkers and Symptoms: Brain Energy for Amyloid Transformation in AD (BEAT-AD) Study protocol. This cohort of patients will receive a maximum of 3 \[11C\]Acetoacetate (AcAc)/\[18F\]Fluorodeoxyglucose (FDG) PET scans over 18 weeks as part of this supplemental trial.

The main objective of this study is to examine the brain biodistribution of \[11C\]AcAc/\[18F\]FDG, a proxy for acetoacetate (ketone body)/glucose metabolism in 3 study groups; 1) those without identifiable risk of Alzheimer's disease, 2) asymptomatic individuals with increased risk of Alzheimer's disease (such as pre diabetes),and 3) those with early Alzheimer's disease or MCI. Secondary objectives include determining the association between adipose tissue distribution/function and biomarkers of AD pathology.

Eligibility Criteria:
Inclusion Criteria:

* Mild cognitive impairment or subjective memory complaints
* Stable medical condition and medications
* Ability to complete baseline assessments

Exclusion Criteria:

* History of a clinically significant stroke
* Sensory impairment (visual, auditory)
* Diabetes requiring medication
* Current use of cholesterol/lipid lowering medications, anticonvulsants, drugs with potential interfering CNS effects (other than cholinesterase inhibitors or memantine), medications with significant anticholinergic activity, anti-parkinsonian medications or regular use of narcotic analgesics
* Untreated hypothyroidism or B12 deficiency
MD-Logic Artificial Pancreas for Automatic Type 1 Diabetes Meals Management

The MDLAP (MD-Logic Artificial Pancreas)system is as an automatic system to regulate glucose levels by delivery of insulin operable in clinical trial settings. The safety of the system was proved in previous inpatient and outpatient trials in large number of patients. In the current study we aim to optimize post-prandial closed-loop glycemic control by developing an automated MD-bolus calculator and to evaluate its safety and efficacy in controlling postprandial blood glucose when used together with the MD-Logic artificial pancreas system in type 1 diabetes patients.

The study will consist of a pilot study with two segments and a main study segment. The aim of each segment is detailed below:

1. Pilot Study - Segment 1 - Hybrid meal bolus ratio The aim of this segment is to evaluate the efficacy and safety of different pre-meal bolus dosing compared to full closed-loop operation with no meal announcement.
2. Pilot Study - Segment 2 - Insulin dosing during meal In this segment we would like to test the optimal distribution of insulin delivery during the meal.
3. Main study - Segment 3 - Automatic bolus calculator In this main segment of the study we will use the results and conclusions from the previous two pilot segments to develop the MD-Bolus Calculator for closed-loop control use. The safety and efficacy of this automated insulin bolus calculator will be tested in a randomized cross-over study that will compare postprandial glycemic control under MDLAP with and without the use of the MD-Bolus Calculator.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes type 1
* Age 14-25 years

  -\>1yr since diagnosis
* Insulin infusion pump therapy for at least 3 months
* HbA1c at inclusion ≤10%
* BMI \< 95th percentile for age and sex
* Patients willing to follow study instructions

Exclusion Criteria:

* Any condition that influence intestinal absorption or motility such as diabetic gastroparesis, celiac disease or malabsorptive states that could affect postprandial glucose absorption.
* any episode of diabetic ketoacidosis within the month prior to study entry and/or severe hypoglycaemia resulting in seizure or loss of consciousness in the month prior to enrolment
* any concomitant disease that may influence metabolic control
* participation in any other interventional study
* known or suspected allergy to trial products
* any significant diseases (such as preexisting seizures or epilepsy) or conditions including psychiatric disorders, eating disorder and substance abuse that in the opinion of the investigator is likely to affect the subjects ability to complete the study or compromise patients safety
* Female subject who is pregnant or planning to become pregnant within the planned study duration.
Short Course Radiotherapy Followed Intensive Chemotherapy With Delayed Surgery for Rectal Cancer With Synchronous Distant Metastasis

Radical treatment of primary rectal cancer with synchronous distant metastases includes surgical resection of primary and metastatic lesion. However, primary rectal cancer in case of metastasized disease are often locally advanced disease and need downsizing before surgery. It is reported that pelvic recurrence rates and distant metastasis rates outside liver are 30\~35% and 60%, respectively. Therefore, combined treatment with radiotherapy and chemotherapy is used. However, the sequence of treatment modalities is not yet definitely established and preoperative chemoradiotherapy and surgical resection is accepted as an option of treatment. Conventional long course chemoradiotherapy delays administration of full-dose chemotherapy, and metastatic lesion can be progressed during chemoradiotherapy. In present study, we evaluate the efficacy of short course radiotherapy (SCRT) followed by full-dose chemotherapy with delayed surgical resection of the primary tumor and metastases.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed adenocarcinoma of rectum
* Lower margin of tumor within 12 cm from anal verge
* Clinically locally advanced (T3-4 or N1-2) disease
* Potentially resectable and synchronous distant metastases in liver and/or lung. The resectability of metastatic lesions is determined by size, number, location, general condition, liver function, and lung function.
* Over 18 years
* Eastern Cooperative Oncology Group performance status 0-2
* Proper organ function (Hemoglobin ≥ 10 g/dl, Absolute neutrophil count (ANC) ≥ 1,500/mm3, Platelet ≥ 100,000/mm3, Creatinine ≤ 1.5 mg/dl, Clearance of creatinine \>50 ml/min using Cockcroft-Gault formula, Bilirubin ≤ 1.5 x upper limit of normal (ULN), Liver enzyme (Aspartate aminotransferase/Alanine transaminase/Alkaline phosphatase) ≤ 2.5 x ULN)
* Subject who should sign on the informed consent form before participate the trial.

Exclusion Criteria:

* Metastases in other organ except liver or lung
* History of other type of malignancies within 3 years other than non-melanoma of the skin or carcinoma in situ of cervix
* Hereditary colorectal cancer (FAP, HNPCC, and etc)
* Bowel obstruction or impending bowel obstruction
* Uncontrolled severe illness, unsuitable to chemoradiotherapy (within 6 months, myocardial infarct, unstable angina, heart failure, uncontrolled arrhythmia, uncontrolled epilepsy, central nervous system disease, psychological disorder, and etc)
* Subject pregnant or breast feeding, or incapable of appropriate contraception
* Unresected synchronous colorectal cancer
* History of prior pelvic radiotherapy
* History of prior chemotherapy for colorectal cancer
* Great surgery within 4 week before study enrollment
* Participant in other trial within 4 week before study enrollment
Preventing Pneumonia and Other Respiratory Problems in Persons With Spinal Cord Injury

It is known that individuals with spinal cord injury are at increased risk for respiratory tract infections like pneumonia. Part of this risk is due to weakened chest and abdominal muscles that are vital to deep breathing and the ability to cough. The purpose of this study is to look at the effectiveness of two different treatments in preventing pneumonia and other respiratory problems in persons with SCI.

This is a randomized controlled trial investigating the effectiveness of two different treatments. Participants will be randomly assigned to one of the two treatment groups. They will not be told the details of the other intervention since this could influence or change their activities during the study.


Eligibility Criteria:
Inclusion Criteria:

* Chronic spinal cord injury that occurred more than 6 months ago
* An impaired ability to cough (cough peak flow less than 300 L/min)
* Oxygen saturation greater than or equal to 95% when awake and not receiving supplemental oxygen
* End-tidal carbon dioxide level less than 43 mm Hg
* Without a fever or other signs of an acute illness for the previous 2 weeks
* Able to learn the treatment protocol and have someone available at home to assist if needed to help set-up and use the equipment

Exclusion Criteria:

* Under 18 years of age
* Currently have a tracheotomy tube
* Have a history of an acute illness in the last 2 weeks
* Have lung disease as seen on chest x-ray that results in a baseline oxygen saturation decreasing below 95% during daytime hours and cannot be normalized by usual way of coughing
* Already utilizing an oximetry protocol
* Have a significant medical complication and psychiatric condition that would interfere with the conduct of the study or interpretation of the study results.