cyrilzakka/clinical-trials huggingface dataset:
The Gilenya Pregnancy Registry

The purpose of the Multi-National Gilenya Pregnancy Exposure Registry in Multiple Sclerosis (MS) is to continuously monitor, evaluate, and assess for major and minor teratogenic effects in the offspring of women exposed to fingolimod before (up to 8 weeks before last menstrual period (LMP)) and during pregnancy in routine clinical practice. The overall aim is to collect and evaluate data on maternal, fetal, and infant outcomes and compare it with reference populations.


Eligibility Criteria:
Inclusion Criteria:

* Any woman with a diagnosis of MS
* Any woman currently pregnant
* Exposure to fingolimod during pregnancy or up to 8 weeks before LMP
* Signed informed consent

Exclusion Criteria:

* There are no specific exclusion criteria for this registry.
HIV and Fat Accumulation

This is a research study to see whether fat accumulation either under the skin or in the body's organs, for example, the liver, improves in men and women who take a drug called telmisartan. The investigators will be looking at how the amount of fat in the body changes when HIV-positive persons on effective anti-HIV therapy take telmisartan. The investigators will be using a CT scan to make this comparison. Telmisartan is not an HIV medication. It is a medication used to treat blood pressure, but has been shown to decrease fat in the organs in people both with and without high blood pressure. The study involves 8 visits over a period of about 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* HIV positive men and women 18 years and older
* HIV-1 infection as documented by ELISA and confirmed by Western blot or plasma HIV-1 RNA \>2000 on two occasions
* Documented central fat accumulation
* HIV RNA documented to be less than 50 copies/mL at screening and undetectable by assay of choice for at least 12 weeks prior to entry
* Current antiretroviral therapy with a suppressive, highly active antiretroviral regimen.
* Systolic BP \>115mmHg.
* Ability and willingness to provide informed consent

Exclusion Criteria:

* Pregnancy (current or within the last 6 months) or nursing
* Uncontrolled hypertension
* Prohibited concomitant medications
* Subjects with untreated hyperlipidemia must be willing to abstain from initiating therapy for the 24 week duration fo the study.
* Subjects undergoing treatment for diabetes with oral hypoglycemic agents must be willing to remain on their current dose of insulin sensitizing agents for the duration of the study.
* Known, untreated renal artery stenosis
* Unstable coronary artery disease/angina or decompensated congestive heart failure.
* Any history of intolerance to any member of the angiotensin receptor blocker class of agents.
* Need for ongoing potassium supplementation.
* Screening laboratory values as follows ANC (absolute neutrophil count) \<750 cells/mm3 Hemoglobin \<10 gm/dL ClCr (creatinine clearance)\< 30 ml/min (estimated by Cockcroft-Gault equation) AST (aspartate aminotransferase) or ALT (alanine aminotransferase) \> 3 x ULN (upper limit of normal)
Autologous Bone Marrow-Derived Mononuclear Cell Transplantation in Accelerating Tissue Expansion and Skin Regeneration

The purpose of this study is to evaluating whether autologous bone marrow mononuclear cells transplantation is safe and/or effective to accelerating skin regeneration and soft tissue expansion.

Reconstruction of large scale skin defect is a challenge to clinical surgeons. Soft tissue expansion has won wide attention in recent years as it promotes skin regeneration with perfectly matched tissue. However, some patients with poor skin regenerative ability would suffer from skin flap over-thinned and even necrosis under the continuous stretching by silicone expander. Although, on some occasions, decelerating the expander inflation process could reduce the incidence of necrosis, this prolonged therapy circle is to be accompanied with increased complications, including infection and expander rupture, as well as the increased economic expenses by the longer hospitalization. This study is to observe the effects of autologous bone marrow mononuclear cell transplantation on accelerating skin regeneration and promoting tissue expansion process.

Patients aged between 18 to 60 years old who appear with deteriorated expanded skin will be enrolled and randomized into two groups, named as the experimental group and the control group. Patients from the experimental group will have a bone marrow aspiration and intradermal mononuclear cells transplantation. On the other side, Patients from the control group will have saline injection.

Eligibility Criteria:
Inclusion Criteria:

* Age of 18 to 60 years;
* Expanding skin donor site at the face, neck, anterior chest wall, abdominal wall or back;
* Implanted silicone expander of 80 to 600 ml in size;
* History of deterioration in the expanded skin texture that did not improve after the inflation procedure was suspended for more than 2 weeks;
* Persistent high level of expander internal pressure;
* Need for further skin expansion;

Exclusion Criteria:

* Not fit for soft tissue expansion treatment;
* Evidence of infection, ischemia, ulcer or other pathological changes within the targeting area which defined as not suitable for expansion; or history of delayed healing, radiational therapy;
* Significant renal, cardiovascular, hepatic and psychiatric diseases;
* Significant medical diseases or infection (including but not limited to the carrier of hepatitis B virus or HIV)
* BMI \>30;
* History of any hematological disease, including leukopenia , thrombocytopenia, or thrombocytosis;
* History of allogenic bone marrow transplantation;
* Long history of smoking;
* Evidence of malignant diseases or unwillingness to participate.
Stelara fOr ChRonic AntibioTic rEfractory pouchitiS

To evaluate the efficacy and safety of ustekinumab in the treatment of chronic antibiotic refractory and relapsing pouchitis.

This study is a Belgian prospective open label multicenter study to evaluate the efficacy and safety of ustekinumab in the treatment of relapsing or chronic antibiotic refractory pouchitis during a 48-week treatment period. Twenty subjects with a RPC and IPAA for UC who have developed relapsing or chronic antibiotic refractory pouchitis will be enrolled.

All patients will receive intravenously (IV) ustekinumab \~6mg/kg at baseline and subcutaneously (SC) ustekinumab 90mg every 8 weeks thereafter until Week 48. All subjects will receive concomitant antibiotic treatment with ciprofloxacin or metronidazole from baseline through Week 4. Intravenous induction doses will be 260mg for patients \<55kg, 390mg for patients between 55 and 85kg, and 520mg for patients with a body weight \>85 kg.

Clinical and biochemical evaluation will be planned every 8 weeks. Efficacy will be assessed at Week 16 and Week 48 using mPDAI and PDAI scores, therefor a pouchoscopy with biopsy sampling will be performed. Patients who do not achieve partial response (reduction of mPDAI score by ≥2 points from baseline) at Week 16 will be discontinued.

Eligibility Criteria:
Inclusion Criteria:

* The subject has a history of ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC)
* The subject has pouchitis that is (a) relapsing or (b) chronic antibiotic refractory, defined by an mPDAI score ≥5 assessed as the average from 3 days immediately prior to the baseline endoscopy visit and a minimum endoscopic subscore of 2 (outside the staple or suture line) with either (a) ≥3 recurrent episodes within the last year, each treated with ≥2 weeks of antibiotic or other prescription therapy, or (b) requiring maintenance antibiotic therapy taken continuously for ≥4 weeks immediately prior to the baseline endoscopy visit

Exclusion Criteria:

* Crohn's disease (CD), CD-related complications of the pouch (pouch fistula, pouch strictures, ulcerations in the pre-pouch ileum without pouchitis), irritable pouch syndrome (IPS), isolated or predominant cuffitis, infectiouw pouchitis, diverting ostomy or mechanical complications of the pouch
* Previous treatment with an anti-IL12/23 or an anti-IL23 antibody
* Any investigational or approved biologic agent within 30 days of baseline
* Nonbiologic investigational therapy or tofacitinib within 30 days prior to baseline
* Active or untreated latent tuberculosis (TB)
* Chronic hepatitis B virus (HBV) infection, chronic hepatitis C virus (HCV) infection, a known history of human immunodeficiency virus (HIV) infection (or is found to be seropositive at screening) or subject is immunodeficient
* Active severe infection (e.g. sepsis, cytomegalovirus, listeriosis or C. difficile)
* History of malignancy or current malignancy
Sexual Health and Breast Cancer: Developing Appropriate Education for Women Going Through Treatment

The purpose of this study is to assess the acceptability, appropriateness, and feasibility of a educational video series for patients going through breast cancer treatment.

This is a prospective, mixed methods pilot study to evaluate the acceptability, appropriateness, and feasibility of a novel educational video series for patients going through breast cancer treatment. The video series addresses topics such as what to expect from breast surgery, how to prepare for breast surgery, treatment effects of breast cancer therapies, and mitigation and communication strategies for navigating breast cancer treatment.

Eligibility Criteria:
Inclusion Criteria:

* Stage I-III invasive breast cancer within one month of initial multi-disciplinary clinic visit or surgical consultation
* Ability to complete survey material independently
* Able to read and speak English
* Willingness to comply with study material and procedures

Exclusion Criteria:

* Age \< 18 years old
* Stage 0 or IV breast cancer
* Non-breast cancer diagnoses
* History of anti-hormonal therapy, chemotherapy, or radiotherapy not related to breast cancer
* Prior breast cancer diagnosis
Assessment of a Specific Neurophysiological Brain Pattern in Patients Suffering From Chronic Back Pain

The purpose of this study is whether patients suffering from chronic back pain for more than one year will show a specific neurophysiological pattern in the EEG. This pattern is referred to as Thalamo-Cortical Dysrhythmia (TCD) and consists most likely of a self sustaining loop between the Cortex and Thalamus. This pattern has been found before in patients with very severe chronic pain. Specific lesions to the Thalamus result in a reduction of this pattern and decrease in pain. With this study the investigators will assess whether this pattern can be found in back pain patients of different types. Patients will be measured by EEG for the existence of TCD and will undergo detailed pain and psychological diagnostic.

The neurophysiological processing of chronic pain is despite large efforts in the recent years still not well understood. However the so called cortical pain matrix describes cortical areas associated with the perception and processing of pain stimuli. Most studies identify second somatic area (SII), the insular regions, the anterior cingulated cortex (ACC) as well as the contralateral thalamus and the primary somatic area (SI) (Peyron, Laurent \& Garcia-Larrea, 2000) as areas related to pain processing. In two recent publications by a Swiss research group (Sarnthein, Stern, Aufenberg, Rousson \& Jeanmonod, 2006; Stern, Jeanmonod \& Sarnthein, 2006) a dynamical EEG in the cortex pattern is described which is obvious related to chronic neurogenic pain. This pattern consists of an increase in EEG power and a shift of the dominant peak towards lower frequencies, mainly high theta (6-9 Hz). Source localization demonstrates that this overactivation mainly takes place in the areas of the cortical pain matrix. The authors argue that this pattern termed thalamocortical dysrhythmia is due to a thalamocortical loops initiated from the central lateral nucleus in the thalamus. This hypothesis is supported by the effects of a therapeutic lesion within the thalamus which led to (a) pain relief of 95% and to (b) the disappearance of the dysrhythmic pattern described above.

The investigators will set out to conduct a observational trial in order to determine pain related EEG characteristics in patients suffering from chonic back pain. Twenty four patients will be recruited for the study. A 64 channel high-resolution EEG and the following parameter will be recorded: Neuropathic Pain Questionnaire (Backonja and Krause 2003), EuroQol, BSI, Graded hronic pain scale(Klasen, Hallner, Schaub, Willburger \& Hasenbring, 2004)pain (McGill Pain Questionnaire, VAS pain), and generic quality of life (Fragebogen zur Lebenszufriedenheit, Henrich \& Herschbach, 1996).

An age and sex matched control group of healthy participants will be measured with the same method in order to compare whether the patients show a dysrhythmia pattern.

Eligibility Criteria:
Inclusion Criteria:

* Chronic back pain of at least one year duration
* Command of German language
* Age 18-70

Exclusion Criteria:

* Psychiatric disorders
* Immune suppression
Fear and Anxiety Level in Dental Patients During the COVID-19 Pandemic

Psychological support may be needed to help patients in the face of emotional disturbances that may be associated with the outbreak and to help them accomplish their fear and anxiety. Due to the increasing fear of COVID-19 transmission during the pandemic, patients may develop treatment avoidance behavior in dental practices. If the fear and anxiety levels of the patients can be determined, it may be easy to offer special approaches to them.

Officially, the first COVID-19 case in Turkey was diagnosed on March 10, 2020. To ensure social isolation, cities were locked down with residents to stay at home to prevent disease transmission. A very large part of the population may experience frustration, stress, and irritability while in isolation. Due to the prolonged lockdown and COVID-19 associated fear, the COVID-19 pandemic, which threatens people's physical health and lives, is likely to trigger a wide variety of psychological problems such as anxiety and depression by increasing their stress levels.

The risk of cross-infection in dentistry has been described as considerably high due to close physical contact between dental professionals and patients, and aerosols production during routine dental treatments. In this uncertain process, patients remain undecided about attending their dental appointments. Their concern is associated with the risk of getting infected and transmitting the disease to family members. All these factors may increase the mental stress of patients.

The essential purpose of this study is to evaluate the COVID-19 fear and anxiety level, COVID-19 knowledge status, and information sources in dental patients in Turkey during the pandemic period.

Eligibility Criteria:
Inclusion Criteria:

* willing to participate with providing informed consent;
* age ≥18 years
* able to understand and read \& write the Turkish language.

Exclusion Criteria:

* not willing to participate with providing informed consent;
* age\<18 years
* not able to understand and read \& write the Turkish language
Unwinding Anxiety for Migraine: Pilot

This is a pilot study that aims to understand the feasibility and acceptability of a mobile health educational app plus group-based mindfulness therapy on anxiety and migraine-related disability among people with migraine.


Eligibility Criteria:
Inclusion Criteria:

* 18 or older
* Meets diagnostic criteria for migraine
* Reports anxiety symptoms of 5 or more on GAD-7
* Has a smartphone

Exclusion Criteria:

* Under the age of 18
* Presence of suicidal ideation
* Reports severe depression on PHQ-9
* Lack of group readiness
Examining Variation in the Impact of School-Wide Positive Behavioral Interventions and Supports (PBIS)

To conduct a randomized controlled trial of School-Wide Positive Behavioral Interventions and Supports, which is a school-based prevention program aimed at reducing behavior problems in children.

To conduct a group randomized controlled trial of School-Wide Positive Behavioral Interventions and Supports. PBIS is a popular school-based prevention program aimed at reducing behavior problems in children. Staff are trained to implement behavioral focused prevention programs to address issues related to student conduct and discipline problems.

Eligibility Criteria:
Inclusion Criteria:

* Public Elementary Schools
* All children attending the schools and staff employed were eligible for inclusion

Exclusion Criteria:

• None
MR-based Hypofractionated Adaptive IGRT of Prostate Cancer (M-base HyPro 2.0)

Single-centre single-armed, non-randomized interventional phase II-study of hypofractionated image-guided radiotherapy "IGRT" with weekly magnetic resonance imagings "MRI" for personalized adaptation of the treatment plan depending on individual MR-anatomy of prostate/organ at risks "OAR" during course of IGRT.

IGRT-schedule: 20 fractions to a total dose of 60 Gy

Personalized adaption of treatment plan dependning on volume-/ and constraint-thresholds and evaluation of biomarkers (multiparametric MRI, blood, tissue, stool, urine).

Treatment at MR-Linac allowed

Eligibility Criteria:
Inclusion Criteria:

* biopsy-proven prostate cancer with indication for RT
* cT1b-cT3a cN0 cM0
* ECOG Performance score 0-2
* IPSS≤12 (before planning computed tomography i.e. reached after neoadjuvant androgen deprivation therapy or tamsulosin)
* age\>18 years
* Informed consent

Exclusion Criteria:

* not fulfilled inclusion criteria
* contraindication against curative RT
* age\<18 years
* previous pelvic radiotherapy or planned pelvic radiotherapy
* comorbidities interfering with image-guided radiotherapy
* contraindications against multiparametric MRI (like hio prosthesis, pacer, allergy against contrast media)
* prior transurethral resection, highly focussed ultrasound or other pre-treatment of prostate
Effect of Dietary Sodium Intake on Blood Pressure in Hypertensive Patients in Primary Care

There is strong evidence that our current consumption of salt is the major factor increasing blood pressure (BP). The current salt intake in most countries in the world is 9 to 12 grams per day (g/d), whil the World Health Organization's recommendation is \< 5 g/d.

The aims of the present study is to determine if the overconsumption of salt influences the bp in patients with uncontrolled hypertension or frequently elevated bp.

Each study subject will complete questionnaires, and their usual dietary salt intake is estimated from food composition on 3 completed food diaries. This is also compared with a 24-hour urine sample collection.

Based on these results, the study subject receives personal advice to decrease sodium consumption and will change the diet for at least 28 days. During this diet, bp will be measured and food diaries will be completed. After the intervention, a questionnaire and a 24-hour urine sample collection will be collected.


Eligibility Criteria:
Inclusion Criteria:

* adults, 50 years of age or older with changing blood pressure (bp) with or without drugs and patients with uncontrolled bp despite drugs
* An average systolic bp on 2 of the 3 previous visits of 140 mm Hg or more (130 mm Hg for diabetics) and an average diastolic bp of 80 to 100 mm Hg.
* Blood analysis (fasting glycaemia, creatinin, total cholesterol, high- density lipoprotein cholesterol) in the last 6 months
* At least 3 criteria of the following:

  * using table salt
  * 2-3/weeks consumption of prepared meals (butchery, warehouse...)
  * 2-3/weeks consumption of effervescent tablet
  * Daily consumption of cheese/cold cuts
  * Daily consumption of salted butter/margarine
  * 2-3/weeks consumption of smoked fish/meat
  * 2-3/weeks consumption of bouillon cube-soup (self-made or preserved)
  * 2-3/weeks consumption of cookies
  * 2-3/weeks consumption of vegetables preserved in jars
  * 2-3/weeks consumption of vegetable juice
  * 2-3/weeks consumption of snacks (chips, cheese, nuts...)

Exclusion Criteria:

* heart failure
* renal insufficiency
* secondary hypertension
* isolated systolic/diastolic hypertension
* bp difference of more than 10 mm Hg between left and right arm
* lactation or pregnancy
* active malignancy
* an active 'low in salt' diet
* changing the use of antihypertensive drugs or other medication that would affect bp for the last 4 weeks
* impaired cognitive functioning$
* planning a smoke cessation
Evaluation of Commonly Used Blood Glucose Meters in Vietnam

Rationale: Most BGM (blood glucose monitoring) devices in Vietnam are manufactured for home use only. However, they are commonly used in healthcare facility, primarily at point of care. We want to assess the validity of these devices by using CLSI (Clinical and Laboratory Standards Institute) POCT12-A3 to assess the accuracy.

Objective: To validate the accuracy and effect of hematocrit on these devices, along with the precision profile using CLSI EP15A3

Study design: This is a cross-sectional study.

Study population: Because we need a wide range of blood glucose level. We chose pregnant women who underwent 75g glucose tolerance test.

Most blood glucose monitors circulating the market are manufactured after ISO 15197:2013 standard, which is intended for self-measurement. Medical organizations need to verify blood glucose monitors if they are designed for prescription point-of-care use or validate blood glucose monitors if they are designed for over-the-counter use.

Pregnant women are selected after consent, their blood are then drawn by phlebotomist into an EDTA (ethylenediamine tetraacetic acid) with NaF (sodium flouride) blood tube. Samples are run on alinity h hematology analyzer, manufactured by Abbott, to measure hematocrit. The analyzers are verified by laboratory procedure, recommended by CLSI (Clinical and Laboratory Standards Institute) method and quality control is checked before in accordance to the laboratory procedure. After that, blood tube is mixed thoroughly before being pipetted. Each BGM device will measure blood glucose level of the pipetted whole blood. Finally, samples will be run on a cobas c 502 analyzer to measure plasma glucose level, which is a reference method for determining the accuracy of the BGM devices.

Statistical analysis: Meter performance is acceptable for use in hospitals when 95% of the individual results from the POC glucose meter system agree within 0.67 mmol/L (12 mg/dL) of the laboratory analyzer values at glucose concentrations below 5.55 mmol/L (100 mg/dL) and within 12.5% of the laboratory analyzer values at glucose concentrations at or above 5.55 mmol/L (100 mg/dL). In addition, the sum of the number of individual results with 1) errors that exceed 0.83 mmol/L (15 mg/dL) at glucose concentrations below 4.2 mmol/L (75 mg/dL) and 2) errors that exceed 20% at glucose concentrations at or above 4.2 mmol/L (75 mg/dL) should not exceed 2% of all results. An ordinary linear regression is performed to see how well the glucose level of BGM devices correlates with the reference method. Bland-Altman difference plots are used to describe the difference along with the hematocrit of each sample.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women undergo 75g glucose tolerance test

Exclusion Criteria:

* Usage of anticoagulant drug
* History of bleeding disorders.