cyrilzakka/clinical-trials huggingface dataset:
Study to Reveal if Fibrinogen Treatment Effects Blood Clotting Better Than a Platelet Transfusion

Patients with need of platelet transfusion for any reason will participate in this study. Directly before the start of infusion and one hour after the end of platelet transfusion blood samples will be drawn and treated with different concentrations of Fibrinogen (a blood clotting factor) in-vitro. Blood samples with and without Fibrinogen/platelet transfusion will be compared. The study hypothesis is that treatment with Fibrinogen results in a better stabilisation of blood coagulation.

In total 300 patients with the need of platelet transfusion for whatever reason will be included when meeting the inclusion- and exclusion criteria.

For all patients three visits are planned, where blood samples will be taken. The first blood samples will be taken directly before the start of platelet transfusion, the second 1 hour after the end of the platelet transfusion and the third after 24 hours.

Untreated citrate and EDTA blood samples from Visit 1 will be serving as baseline for the coagulation testing. Further citrate blood samples from the first visit will be spiked with different concentrations of fibrinogen in vitro. Untreated citrate and EDTA blood samples will be taken 1 hour and 24 hours after platelet transfusion for comparison. Further citrate blood samples will be spiked with different concentrations of fibrinogen in vitro again 1 hour after platelet transfusion. In addition, randomly chosen samples will be analyzed using confocal microscopy. Routine coagulation analysis include activated partial thromboplastin time (aPTT), prothrombin time(PT), fibrinogen, blood coagulation factor thirteen (FXIII), thromboelastometry (ExTEM \& FibTEM) before and after platelet transfusion.

Eligibility Criteria:
Inclusion Criteria:

* patient with the clinical need for platelet transfusion
* age: 18 - 85 years

Exclusion Criteria:

* pregnant or nursing women
* patients who disagree to participate in the study

  * for emergency patients: patients with known refusal of a participation in this clinical trial
* active participation in a clinical trial
* any condition, including the presence of laboratory abnormalities, which would place confound in the ability to interpret data from the study
* any serious medical condition, laboratory abnormalities, or psychiatric illness, that would prevent the subject from signing the informed consent form
Periconceptional Surveillance in India

Women of reproductive age are a high-risk population for anaemia and micronutrient deficiencies. Evidence supports the role of periconceptional nutrition in the development of adverse pregnancy complications. However, in India, there are limited population-based data to guide evidence-based recommendations and priority setting. The objective of this study is to conduct a population-based biomarker survey of anaemia and vitamin B12 and folate status in women of reproductive age as part of a periconceptional surveillance program in Southern India.

Women of reproductive age are a high-risk population for anemia and micronutrient deficiencies due to social structures, and the physical demands of pregnancy and lactation particularly in South Asia. Inadequate periconceptional folate and vitamin B12 status are implicated in the development of birth defects and other pregnancy complications. Randomized trials established that periconceptional folic acid supplementation can prevent the occurrence and recurrence of neural tube defects, and fortification of staple foods with folic acid has been associated with decreasing neural tube defects in many countries around the globe. Red blood cell folate has been identified as a biomarker of neural tube defect risk at the population level, and increases in RBC folate concentrations predicted reductions in neural tube defect risk of up to 10-fold in USA, Chinese and Irish populations.

Emerging evidence has identified maternal vitamin B12 deficiency as a risk factor for neural tube defects, and vitamin B12 status may modify circulating folate biomarkers that predict neural tube defect risk. It is estimated that the burden of neural tube defects in India is among the highest in the world. However, there is little representative population-level data from Southern India. Surveillance programs are urgently needed to establish the burden of anaemia and key micronutrient deficiencies in settings such as Southern India to inform interventions for anemia and birth defects prevention.

The objective of this study is to conduct a biomarker survey of anemia and vitamin B12 and folate status in women of reproductive age as part of a periconceptional surveillance program in Southern India and to inform the development of a randomized trial for anemia and birth defects prevention. As part of this surveillance program, we are also establishing the World Health Organization-recommended microbiological assay for folate at our laboratory in Bangalore, India, and a WHO-SEARO site for birth defects surveillance in this setting. Findings from this pre-intervention biomarker survey will directly inform the development of a randomized efficacy trial of quadruple-fortified salt for the prevention of anemia and birth defects in Southern India and serve as the foundation for future public health programs to improve the health of women and young children in this population.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Aged 15 to 49 years
* Currently not pregnant or lactating

Exclusion Criteria:

* \<15 or \>49 years old
* Currently pregnant or lactating
A Study To Observe Safety And Blood Concentrations Of PF-04995274 During And Following the Administration of Multiple Doses Of PF-04995274 In Healthy Adult And Healthy Elderly Volunteers.

This study is designed to observe the safety and blood concentrations of PF-04995274 during and following the administration of multiple doses of PF-04995274 for a duration of 14 days, in healthy adult and healthy elderly.

To examine the safety and pharmacokinetics of PF-04995274 in healthy adult and healthy elderly subjects after multiple doses.

Eligibility Criteria:
Inclusion Criteria:

* For Healthy adult volunteers: healthy male and/or female subjects of non child bearing potential between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12 lead ECG and clinical laboratory tests.)
* For Healthy Elderly volunteers: healthy male and/or female subjects of non child bearing potential between the ages of 65 and 85 years, inclusive. Subjects must be in reasonably good health as determined by the investigator based on a detailed medical history, full physical examination (including blood pressure and pulse rate measurement), 12 lead ECG and clinical laboratory tests. Subjects with mild, chronic, stable disease (eg, controlled hypertension, non-insulin dependent diabetes, osteoarthritis) may be enrolled if deemed medically prudent by the investigator. In order to ensure an age range relevant to the Alzheimer's Disease (AD) population, no more than 30% of subjects enrolled in any cohort may be less than 70 years of age.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
Contrast-Enhanced Ultrasound in the Evaluation of Abdominal Injuries in Children

This study proposes to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in diagnosing abdominal solid organ injuries in pediatric patients. 146 subjects will be enrolled across approximately 8 sites in the US. All subjects will have had a Computerized Tomography (CT) scan as part of standard of care, confirming at least one solid organ abdominal injury. All subjects will have an abdominal ultrasound without contrast, followed by a contrast-enhanced ultrasound using the contrast agent Lumason. Ultrasound and contrast-enhanced ultrasound results will be compared to the CT scan results. The study procedures will take place within 48 hours of injury.

This is an interventional study proposes to evaluate the accuracy of contrast-enhanced ultrasound (CEUS) in diagnosing abdominal solid organ injuries in pediatric patients. 146 subjects will be enrolled across approximately 8 sites in the US. All subjects will have had a Computerized Tomography (CT) scan as part of standard of care, confirming at least one solid organ abdominal injury. All subjects will have an abdominal ultrasound without contrast, followed by a contrast-enhanced ultrasound using the contrast agent Lumason. Ultrasound and contrast-enhanced ultrasound results will be compared to the CT scan results. The study procedures will take place within 48 hours of injury. At conclusion of enrollment of all subjects a centralized review of CT vs. CEUS will occur to compare to real time readings.

Eligibility Criteria:
Inclusion Criteria:

* Hemodynamically stable, as determined by the trauma team
* Age 8 through 17 years
* Interpretable CT of the abdomen and pelvis that demonstrates at least one abdominal solid organ injury among the liver, spleen, pancreas, and kidneys
* Plan for observation or admission to the hospital
* Candidate for abdominal ultrasound based on body habitus
* Have a Glasgow Coma Score of 15
* Able to complete the study procedures within 48 hours of injury

Exclusion Criteria:

* Known cardiac abnormality
* Pulmonary hypertension
* Known sensitivity to sulfur hexafluoride, polyethylene glycol 4000, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), or palmitic acid
* Unable to roll over
* Unable to assent
* Pregnant
* Lactating
* CT images not available for transmission to central image repository
A Study of AAV2-GDNF in Adults With Moderate Parkinson's Disease (REGENERATE-PD)

The objective of this randomized, surgically controlled, double-blinded, Phase 2 study is to evaluate the safety and efficacy of AAV2-GDNF delivered to the putamen in subjects with moderate Parkinson's Disease.


Eligibility Criteria:
Inclusion Criteria:

Age

1. Male and female adults 45-75 years of age inclusive, at the time of signing of informed consent Type of Subject and Disease Characteristics
2. Diagnosed with Parkinson's Disease in the past 4-10 years (inclusive) as defined by the following:

   1. Presence of bradykinesia PLUS any of the following:

      * Rigidity
      * Rest Tremor
      * Postural instability
   2. Presence of motor fluctuations as measured by the PD Motor Diary
   3. Stable anti-parkinsonian medication regiment for \>/= 4 weeks prior to screening
   4. Must demonstrate responsiveness to levodopa therapy

Exclusion Criteria:

* Known history or current evidence of medical, genetic, or neurological conditions that may provide an alternative to idiopathic PD diagnosis
* Presence or history of significant vascular and/or cardiovascular disease
* Presence of significant cognitive impairment, poorly controlled depression/anxiety
* Presence or history of psychosis or impulse control disorder
* History of malignancy other than treated cutaneous squamous or basal cell carcinomas
* Presence of clinically relevant conditions that could compromise surgical suitability and/or subject safety
* Contraindication to magnetic resonance imaging and/or use gadolinium-based contrast agents
* Prior history of brain surgery including, but no limited: DBS, pallidotomy focused ultrasound thalamotomy, or other experimental neurosurgical procedure
* Chronic immunosuppressive therapy
Use of Molecular Breast Imaging (MBI) to Detect Additional Disease in Women With Breast Cancer Who Are About to go to Surgery

Conventional mammography is not a reliable method for determining the extent of disease in women with breast cancer. Molecular Breast Imaging (MBI) is a new nuclear medicine technique that allows the breast to be imaged in a manner similar to mammography, but without the pain of compression. Initial results with this method have shown it is very good at detecting small breast cancers (\~1/4 inch).

The purpose of this study is to see if MBI is a better method than mammography in determining how much cancer is present before a woman goes to surgery.

The study will comprise 120 women with breast cancer who are going to surgery. The investigators hope that this study will demonstrate that MBI will be more accurate in determining how much cancer is present.

The sensitivity of conventional mammography for evaluation of extent of disease, detection of multifocal breast cancers and contralateral breast cancers is poor. Molecular Breast Imaging (MBI) is a new nuclear medicine technique that permits the breast to be imaged in a manner similar to mammography, utilizing a Cadmium-Zinc-Telluride (CZT) gamma camera. We have developed the first dual-head MBI system in the world and preliminary results from this system indicate a high sensitivity (\~90%) for the detection of breast cancers \< 10mm.

The AIM of this study is to determine the sensitivity of MBI relative to mammography in the preoperative evaluation of the extent of disease in the ipsilateral and contralateral breasts in women with biopsy-proven breast cancer. We will test the HYPOTHESIS that MBI is more sensitive than mammography for preoperative evaluation and surgical planning.

The study will comprise 120 women with biopsy-proven breast cancer prior to surgery. All patients will have a diagnostic mammogram and an MBI study prior to operation. At the time of operation the pathologic findings will be correlated with both the mammogram and the MBI results.

This study will demonstrate the use of MBI in three aspects of breast cancer diagnosis: 1) detection of multifocal / multicentric disease elsewhere in the ipsilateral breast, 2) detection of contralateral breast cancer, and 3) correlation of index tumor size on MBI with pathologic size. These results may justify a role for MBI in the routine pre-operative evaluation of breast cancer patients.

Eligibility Criteria:
Inclusion Criteria:

* Women with biopsy-proven breast cancer (invasive breast cancer or ductal carcinoma in situ)

Exclusion Criteria:

* Unable to understand and sign the consent form
* Pregnant or lactating
* Physically unable to sit upright and still for 40 minutes
* Currently receiving neoadjuvant chemotherapy or hormonal therapy
* Currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor
* Previous mastectomy
* Previous excisional biopsy of the index breast cancer
DBT to Enhance Health Behaviour Change for Adolescents Living With Obesity

This research is being conducted to evaluate emotion-focused therapy that incorporates elements of mindfulness, distress tolerance, and relationship support. The investigators want to learn if this therapy, called Dialectical Behavioral Therapy (DBT) will help improve quality of life and weight management in youth at risk for type 2 diabetes. Individuals will be randomly assigned to weekly group based session in one of 3 intervention arms; lifestyle + DBT, lifestyle alone, or a control arm.


Eligibility Criteria:
Inclusion Criteria:

* 14-17 years old
* BMI z-score \>1.6
* signs of mild-moderate depression (PHQ-9 score 5-19)
* willing and able to comply with study procedures

Exclusion Criteria:

* more than one health co-morbidity
* being treated with medication for obesity
* taking steroids
* currently being treated for atypical antipsychotics
* have an orthopedic injury or chronic illness that would prevent them from performing the intervention
* experienced weight loss or enrolled in weight loss program in the six months prior to the study
* self reported history of alcoholism or drug abuse
* history of self-harm or suicide attempts in the past 12 months
* currently enrolled in psychotherapy or DBT
* parents do not approve of you participating
* unable/unwilling to give assent/consent
Comparison of Loading Dose Magnesium Sulphate With Prichard Regimen in the Management of Severe Preeclampsia and Eclampsia.

Preeclampsia/eclampsia is part of a spectrum of multi-systemic pregnancy disorder that contributes substantially to maternal and perinatal morbidity and mortality, especially in low resource setting. This study was done in Abakaliki, Ebonyi State, Southeast Nigeria.

To compare the efficacy of loading dose of magnesium sulphate with that of the Pritchard regimen in the prevention of eclampsia in severe preeclampsia and recurrent fits in eclampsia in a low resource setting.

A prospective, single blinded randomized controlled study of loading dose versus Pritchard regimens of MgSO4 at the Teaching Hospital Abakaliki. One hundred and twenty patients were recruited 60 to each arm using computer-generated numbers. Sociodemographic characteristics, efficacy and adverse effects of the drug on the mother and baby were noted.

Background: Preeclampsia/eclampsia is part of a spectrum of multi-systemic pregnancy disorder that contributes substantially to maternal and perinatal morbidity and mortality, especially in low resource setting. This study was done in Abakaliki, Ebonyi State, Southeast Nigeria.

Objectives: To compare the efficacy of loading dose of magnesium sulphate with that of the Pritchard regimen in the prevention of eclampsia in patients with severe preeclampsia and recurrent fits in eclampsia in a low resource setting like ours.

Methods: This was a prospective, single blinded randomized controlled study of loading dose versus Pritchard regimens of MgSO4 at Alex Ekwueme Federal University Teaching Hospital Abakaliki. One hundred and twenty patients were recruited 60 to each arm using computer-generated numbers. Social demographic characteristics, efficacy and adverse effects of the drug on the mother and baby were noted. Data were collated, tabulated and analyzed using the statistical package for social sciences (SPSS) software (version 22, Chicago II, USA)

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with severe preeclampsia
* Pregnant women with eclampsia
* Signing of informed consented to participate in the study.

Exclusion Criteria:

* Refusal of consent,
* Gestational age \< 28 weeks
* Received magnesium sulphate prior to presentation
* mild preeclampsia
* chronic hypertension in pregnancy
* Medical or Obstetrical complication of pregnancy.
Mesenchymal Stem Cells for Progressive Multiple Sclerosis_Sweden

To assess the safety of a single dose of IV infusion of bone-marrow derived autologous Mesenchymal Stem Cells (MSCs) in Multiple Sclerosis (MS) with progressive disease status.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of MS

   1. Active relapsing remitting MS (RRMS) as evidenced by presence of ≥ 1 clinically documented relapse in the past 12 months or ≥2 clinically documented relapses in the last 24 months.
   2. Secondary progressive MS with clinical progression as evidenced by an increase of 1 EDSS point (or 0,5 p if EDSS ≥ 5 at time for study start) in the last year or evidenced by ≥1 relapse or ≥ GEL at MRI performed within the last year.
   3. Primary progressive MS with clinical progression as evidenced by an increase of 1 EDSS point (or 0,5 p if EDSS ≥ 5 at time for study start) in the last year.
2. Age_ 18-65 years
3. Disease duration: 2-20 years
4. EDSS 3,0-7,0

Exclusion Criteria:

1. Subtype of MS not fulfilling inclusion criteria
2. Treatment with any immunosuppressive therapy, including natalizumab and fingolimod, within the 3 months prior to randomization
3. Treatment with interferon-beta or glatiramer acetate within the 30 days prior to randomization
4. Treatment with corticosteroids within the 30 days prior to randomization
5. Relapse occurred during the 60 days prior to randomization
6. Previous history of a malignancy other than basal cell carcinoma of the skin or carcinoma in situ that has been in remission for more than one year
7. Severely limited life expectancy by another co-morbid illness
8. Active or chronic severe infection.
9. History of previous diagnosis of myelodysplasia or previous hematologic disease or current clinically relevant abnormalities of white blood cell counts
10. Pregnancy or risk or pregnancy (this includes patients that are unwilling to practice active contraception during the duration of the study)
11. eGFR \< 60 mL/min/1.73m2 or known renal failure or inability to undergo MRI examination.
12. Inability to give written informed consent in accordance with research ethics board guidelines
Reno- and Vascular Protective Effect of a Vitamin-D-analogue in Moderate to Severe Chronic Kidney Disease

Recently it has been documented that vitamin D has important functions in the human body that are unrelated to its primary effects in calcium homeostasis and bone mineralization. In clinical studies, paricalcitol - a low-calcemic vitamin D analogue - has been shown to decrease proteinuria, a marker of disease progression and cardiovascular risk in patients with chronic kidney disease (CKD). The purpose of this study is to investigate the effect of a paricalcitol on renal and cardiovascular variables in patients with moderate to severe CKD.


Eligibility Criteria:
Inclusion Criteria:

* Kidney disease corresponding to eGFR: 15-59 ml/min
* Albuminuria \> 30 mg/l

Exclusion Criteria:

* Total parathyroidectomy
* Diabetes Mellitus
* Cancer
* Illicit drug or alcohol abuse
* Pregnancy og nursing
* Ongoing NSAID or corticosteroid treatment
* b-hemoglobin \< 6 mmol/l
* p-albumin \< 25 mmol/l
* Clinically significant hypercalcemia
* Office blood pressure \> 170/105 mmHg that despite antihypertensive treatment still is \> 170/105 mmHg when using home blood pressure measurements or 24-hour ambulatory blood pressure measurement.
Differential Effects of Milk Proteins on Postprandial Lipemia in Response to a Fat-Rich Meal in Type 2 Diabetes

Enhanced and prolonged postprandial triglyceride responses involve increased cardiovascular risk in type 2 diabetes. It has been demonstrated that dietary fat and carbohydrates profoundly influence postprandial hypertriglyceridemia in type 2 diabetes, whereas little information exists about the effect of proteins.

The purpose of this study is to compare the effects of the milk proteins casein, Whey Isolate, Whey Hydrolysate, and Alphalact-Albumin on postprandial lipid and incretin responses to a high-fat meal in type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes

Exclusion Criteria:

* Liver-, Kidney- and/or Heart Disease
* Serious Hypertension (160/110 mmHg)