cyrilzakka/clinical-trials huggingface dataset:
Magnevist® Injection Enhanced MRA Compared to Non Contrast MRA for the Detection of Structural Abnormalities of the Aortic Arch and Cerebral Branches

The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Magnevist (the study drug) used for MRI of the aortic arch and cerebral branches. The results will be compared to the results of MRI taken without Magnevist, and with the results of your X-ray angiography.

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Eligibility Criteria:
Inclusion Criteria:

* Has known or suspected disease of the aortic arch and cerebral branches
* Is scheduled for X-ray angiography

Exclusion Criteria:

* Has any contraindication to magnetic resonance imaging
* Is scheduled for any procedure before the X-ray angiography
* Had previous bilateral intervention (surgery, bypass) of the arteries of interest
68Ga-FAPI PET/CT in Patients With Various Fibrotic Disease

To evaluate the potential value of 68Ga-FAPI-04 positron emission tomography/ computed tomography (PET/CT) for the diagnosis and prognosis in fibrotic disease

Subjects with fibrotic disease underwent 68Ga-FAPI-04 PET/CT scanning. Fibrosis lesion uptake was quantified by the maximum standard uptake value (SUVmax). Subjects also received the conventional clinical assessment for liver fibrosis, such as magnetic resonance imaging(MRI) , biopsy and blood biochemical indexes (BBI) testing. The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga-FAPI-04 PET/CT, MRI and BBI were calculated and compared to evaluate the diagnostic efficacy.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (aged 18 years or order)
* patients with suspected or new diagnosed fibrotic disease (supporting evidence may include , BBI, MRI, CT and pathology report)
* patients who had scheduled 68Ga-FAPI-04 PET/CT scan
* patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee

Exclusion Criteria:

* patients with pregnancy
* the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent
Bone Development in Adolescent Girls: Effects of Calcium and Exercise

Osteoporosis is a major public health problem. Prevention of osteoporosis depends in part on good bone development in childhood and adolescence. This study will evaluate a weight-bearing exercise program and high-calcium diet on bone development in adolescent girls.

There are currently few safe and effective methods for restoring lost bone to the osteoporotic skeleton. Therefore, prevention of osteoporosis is crucial. If skeletal development can be maximized during growth, young people will begin adulthood with optimal bone mass and will be less likely to develop osteoporosis in later years. This study will determine the effects of weight-bearing physical activity and a high-calcium diet on bone mass in adolescent girls.

Participants in this study will be randomized to one of three study arms. Girls in Arm 1 will consume their usual diets and will participate in a weight-bearing exercise program that meets 3 times per week. Girls in Arm 2 will also participate in a weight-bearing exercise program that meets 3 times per week and will be given high calcium foods to supply 1500 mg of calcium per day. Girls in Arm 3 will consume their usual diet and maintain their customary activity level. Study visits occur every 6 months; participants will be followed for 4 ½ years. Assessments will include a medical and social history and measurements of spine, hip, radius, and total body bone mineral content (BMC); calcaneal speed of sound (SOS); height; weight; and Tanner stage.

Eligibility Criteria:
Inclusion Criteria

* Tanner Stage of Development: Stage 1

Exclusion Criteria

* History of lactose intolerance, milk allergy, corticosteroid or anticonvulsant therapy, familial hypercholesterolemia, mental or physical handicaps, cancer, rheumatoid arthritis, asthma, or any other significant health problem
* Body mass index (BMI) \>= 85th percentile for age and gender
* Regularly have more than two practice sessions per week of dance, gymnastics, or organized team sports
Quality of Postpartum Cesarean Recovery Score Validity Reliability

In order to provide the best care of patients after cesarean section, to help solve all their biopsychosocial problems in the recovery process, and to shorten the hospitalization period, it should be measured with appropriate measurement tools for various evaluations. The Scale of Post-cesarean Healing Quality You will provide in adapting the ObsQoR-11 questionnaire to Turkish.

In order to provide the best care of patients after cesarean section, to help solve all their biopsychosocial problems in the recovery process, and to shorten the hospitalization period, it should be measured with appropriate measurement tools for various evaluations. We will provide the Scale of Post-Cesarean Healing Quality in adapting the ObsQoR-11 questionnaire to Turkish.It is important to define well the recovery after cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* Must be Over 18 age,
* Must be literate women,
* Must be no neurological disease

Exclusion Criteria:

* Must be unwilling to participate in the study
* Must be under 18 years old women
Adjuvant Treatment of Gastric Cancer With Chemotherapy and Chemoradiotherapy (TRACE)

Post-operative radio-chemotherapy decrease the recurrence risk of gastric cancer(N Engl J Med 2001). However the chemotherapy regimen (5 fluorouracil IV bolus) used was toxic and suboptimal. We propose to evaluate in adjuvant situation an active and well tolerate chemotherapy regimen (FOLFIRI)in patients with metastatic gastric cancer. During the radiotherapy we will use 5 FU continue infusion as previously reported. The global design of adjuvant treatment will be four FOLFIRI courses, radiotherapy (45 Gy)with 5FU IV continue then four FOLFIRI.


Eligibility Criteria:
Inclusion Criteria:

* gastric adenocarcinoma histologically confirmed
* tumor T3 or N+ at the pretherapeutic staging (Scanner and endoscopic ultrasound)
* performance status WHO\<2
* serum albumin \>30 gr/l
* weight loss \< 10% in the next 6 months
* signed informed consent form

Exclusion Criteria:

* metastatic disease
* prior abdominal radiotherapy
Validation of 99mTc- EDDA - HYNIC -TOC Kits for Diagnosis of Neuroendocrine Tumors

Evaluation of the properties of the image capture test using 99m Tc - HYNIC -TOC EDDA (octreotide labeled with 99mTc) for the diagnosis of neuroendocrine tumors compared to the 111In - DTPA-octreotide.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histological diagnosis of neuroendocrine tumors
* Patients with indication for the staging exam with 11In
* Patients diagnosed in any tumor stage
* Patients with \> 18 years
* Male and female patients
* Patients not receiving somatostatin analogues for at least 1 month before image capturing

Exclusion Criteria:

* Pregnant women
* Patients with previous tumor resection of the primary tumor without metastatic disease
Osteonecrosis in Children With Acute Lymphoblastic Leukemia

Acute lymphoblastic leukemia is the most common form of childhood cancer with current treatment survival rates approaching 80%. Improved outcomes show an increased number of survivors at risk for long-term treatment related side effects including osteonecrosis. Osteonecrosis, or bone death, is caused by blood supply loss to the bone causing pain and poor quality of life. The hips, shoulders, knees and ankles may be affected. Pain is the usual presenting symptom and may become severe requiring surgical decompression or replacement of the affected joint. Long-term effects including arthritis and progressive joint difficulties will not be known for decades. This study aims to determine the risk factors for developing osteonecrosis that will lead to information for earlier detection and prevention. The study will be the basis for future intervention and prevention trials.


Eligibility Criteria:
Inclusion Criteria:

* Enrollment in the STOPP-CIS study
* Informed consent of patient or care givers
* \>5 years of age at MRI assessment

Exclusion Criteria:

* Individuals with a history of claustrophobia precluding MRI assessment
Metformin Versus Vildagliptin in Reducing Risk of Metabolic Syndrome Complications Progression

Several crosssectional and prospective studies have shown that metabolic syndrome and its related components are associated with both prevalent and incident CKD .

Although the mechanisms for these cardiovascular benefits of Metformin and vildagliptin remain unclear, they extend well beyond glycemic lowering, and therefore are probably best considered diverse "cardiometabolic" pharmaceuticals rather than simply type 2 diabetes drugs.

Metformin and vildagliptin have known vasculoprotective actions, but the value of these drugs on drug-naïve diabetic patients during 24 week use warrants investigation. The investigator's purpose was to observe their effects on weight control, Cardiometabolic Risk Factors, Metabolic Syndrome risk, and diabetic nephrooathy Progression.

the current study is investigating the relation betweeneach componant of metabolic syndrome and kidney injury incidence or prevalence, and the mechanism of its occurence. the kidney protective effect of metformin and vildagliptin and the mechanism of this action whether it is related to their glucose lowering mechanism or not is also one of the important points to be investigated in the study

Eligibility Criteria:
Inclusion Criteria:

1. men or women 40-70 years of age
2. body mass index be-tween≥22 and ≤40 kg/m2.
3. DM with an HbA1c ≥ 7

Exclusion Criteria:

(1) pregnant or nursing women; (2) chronic (\>7 consecutive days) oral, parenteral or intra-articular corticosteroid treatment within 8 weeks prior to Visit 1 (3) history or evidence of major hepatopathy (aspartate aminotransferase or alanineaminotransferase activities \> 2.5 times the upper limit of normal) (4) ischemic heart disease or cerebrovascular disease (5) creatinine level \> 0.133 mmol/L (6) major diabetes complications (chronic renal insufficiency, proliferative retinopathy and stroke); (7) extreme dyslipidemia, such as familial hypercholesterolaemia

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Ginkgo Biloba Vs Desmopressin in Treatment of Children with Monosymptomatic Nocturnal Enuresis

the efficacy of Ginkgo Biloba versus desmopressin in treatment of children with monosymptomatic nocturnal enuresis

Bedwetting among children is a common disorder, affecting 30% at age 4, 10% at age 6, 3% at age 12, and 1% at age. Untreated, the spontaneous cure rate is about 15% a year. Treatment is dominated by two approaches, enuresis alarm and drugs.

Treatment with drugs has largely been focused on tricyclic antidepressants especially imipramine or, more recently, antidiuretic agents such as desmopressin. For imipramine the proportion of total remission is 10-50% during treatment and a long term cure in 5-40%. However, numerous reports of side effects, some lethal, have led to a decline in its use.

One of theory of nocturnal enuresis is deep sleep in children, this the main cornerstone in using Alarm as line of management.

On the other hand drugs used in re-habitation of sleep rhythm seems to be with great benefits in management as GINKGO BILOBA.

Ginkgo biloba leave extract is among the most widely sold herbal dietary supplements in the United States. Its purported biological effects include: scavenging free radical; lowering oxidative stress; reducing neural damages, reducing platelets aggregation; anti-inflammation; anti-tumor activities; anti-aging, and improve night sleep rhythm.

the aim of this study is to evaluate the effect of Ginkgo Biloba versus desmopressin in treatment of children with monosymptomatic nocturnal enuresis.

Eligibility Criteria:
Inclusion Criteria:

* all children with monosymptomatic nocturnal enuresis.

Exclusion Criteria:

* children with day and night wetting.
Web-Based and Tailored Asthma Management Intervention (Puff City) in Teens With Asthma Attending Urban Clinics

The purpose of this study is to evaluate the Puff City web-based behavioral intervention of asthma management program in a clinical setting. This study also examines and evaluates the cost and efficiency of patient eligibility determination methods, patient recruitment, study monitoring (compliance with study regimen, participant retention and follow-up), and the collection of clinical endpoints.

Asthma continues to be a major public health problem in the US with high economic and social costs. Vulnerable ethnic communities are disproportionately affected by asthma as demonstrated by higher morbidity and mortality for these groups. We have completed two school-based, randomized trials of a web-based, computer-tailored asthma management intervention that targets urban teens (Puff City).

The current study, Puff City in the Clinic, will be evaluated as a clinical tool by initiating the web-based behavioral intervention of asthma management in a clinical setting. However, the current paradigm for conducting such a trial is costly with respect to patient recruitment, intervention delivery, and data collection and management. To address these high costs, the study utilizes comparative effectiveness research (CER) pragmatic approaches to design a randomized controlled trial for patient recruitment and determination of eligibility, study monitoring (compliance with study regimen, participant retention and follow-up), and collection of clinical endpoints.

Eligibility Criteria:
Inclusion Criteria:

* 13-19 years of age
* Must be able to provide electronic assent and have consent from a parent/guardian if applicable
* Diagnosis of asthma by meeting one of the following criteria within the last 12 months:

  * At least one emergency department diagnosis of asthma or
  * At least one acute inpatient encounter with asthma as the principal diagnosis or
  * At least four outpatient visits with an asthma diagnosis and at least 2 asthma medications dispensed or
  * At least four asthma medications dispensed

Exclusion Criteria:

* Inability to provide informed consent/assent
* Lack of physician diagnosis of asthma
* Other co-morbidities that make it impossible for the individual to participate.
STRIBILD in Non-Nucleoside Resistant Patients (SINNR STUDY)

The SINNR study will evaluate the virologic efficacy (viral load \<50 copies/mL)and safety of STRIBILD administered for 48 weeks to HIV-infected current or recent illicit drug users.

The SINNR study is a pilot, observational, open label study. It will evaluate the virologic efficacy (viral load \<50 copies/mL), safety, and immunologic response of STRIBILD administered for 48 weeks to HIV-infected current or recent illicit drug users.

Approximately 30 HIV-infected current or recent illicit drug users (≥19y.o.,\<70y.o.) from Vancouver Infectious Diseases Centre and Regina General Hospital, University of Saskatchewan will be taking an oral 1 STRIBILD tablet once a day for 48 weeks.

Additionally, adherence to STRIBILD over 48 weeks and quality of life will be measured in this population.

Eligibility Criteria:
Inclusion Criteria:

1. Participant is at least 19 years of age and less than 70 years of age infected with HIV and requiring antiretroviral therapy on medical grounds and who has acquired HIV infection through illicit drug use.
2. Participant has documented resistance to NNRTIs, with the presence of one or more primary resistance mutations (Stanford database), on current or previous therapy.
3. The primary care provider decides to prescribe STRIBILD.
4. Participant has no ongoing issues that would lead to significant non-compliance with the study procedures even in the presence of optimal adherence support structures.
5. Participant is able to read and write in the language of the questionnaires and give informed consent.
6. Participant must not be taking any medication that could interact with STRIBILD.
7. If female, participant must have a negative pregnancy test and agree to use, for the duration of the study, a method of birth control that has a history of proven reliability as judged by the investigator.

Exclusion Criteria:

1. Participant has previous exposure to STRIBILD.
2. Participant has documented resistance to any of the components of STRIBILD.
3. Participant is pregnant or breast-feeding.
4. Participant has a contraindication to the use of STRIBILD for any reason.
5. Participant has active hepatitis B (HbsAg positive).
6. Participant has any of the following abnormal laboratory test results at screening:

   Hemoglobin less than 10.0 g/dL, Absolute neutrophil count less than 750 cells/mL, Platelet count less than 50,000/mL, ALT or AST less than 5x Upper Limit of Normal (ULN), Creatinine less than 1.5 x ULN.
7. Participant, in the opinion of the principal investigator, is unlikely to comply with the study protocol or is unsuitable for any other reason.
Cerebral Resonance Magnetic Imaging During Rectal Distention

Irritable bowel syndrome is responsible for chronic abdominal pain, diarrhea and/or constipation. It is a very frequent problem. However, the exact cause of irritable bowel syndrome remains unknown. The purpose of this study is to look for a different cerebral response by magnetic resonance imaging after rectal stimulation in patients with irritable bowel syndrome compared to healthy subjects and to patients with digestive organic disease. Our hypothesis is that irritable bowel syndrome could be a problem of cerebral integration of visceral stimulation.


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects irritable bowel syndrome (Rome II criteria) colitis ulcerative

Exclusion Criteria:

pregnant or breast feeding metallic material implanted good tolerance of rectal distension acute phase of ulcerative colitis
Transfer Accuracy of Indirectly Bonded Orthodontic Braces With Different Transfer Trays

The aim of this study is to comparatively investigate the performances of two different and widely used transfer trays during indirect bonding of the orthodontic braces.

The aim of the study is to compare the accuracy of orthodontic bracket and tube transfer between double layer silicone and double layer vacuum formed trays. The sample included 368 attachments bonded in 16 patients. Each patient received one silicone and one vacuum formed tray which were randomly allocated to provide 8 trays of each type for the upper and lower arches. 3D scan data and local best-fit alignments were used to calculate the translational and rotational movements of the orthodontic attachments. Chi-square and Mann-Whitney U tests were used to compare transfer accuracy and success between the groups.

Eligibility Criteria:
Inclusion Criteria:

* The presence of indication for both arches to be bonded in the same appointment

Exclusion Criteria:

* Presence of restorations, hypoplasia or decalcification on vestibular tooth surfaces
* Abnormal crown morphology
DETECTion of the Prevalence of Silent Atherosclerosis Across Adult Life

Atherosclerosis is preventable, yet it continues to significantly contribute to global morbidity and mortality. Atherosclerosis may occur early in life and may present in all vascular territories. The DETECT study's main aim is to determine the prevalence of asymptomatic atherosclerosis (silent) in an adult population of a wide age range of European ancestry through vascular ultrasound (VUS) of peripheral arteries (carotid and femoral territories), as well as establishing the relationship between atherosclerosis in peripheral arteries, coronary arteries, and other vascular territories assessed by computed tomography angiography (CTA).

The DETECT study also aims to identify risk factors for development of subclinical atherosclerosis that can hopefully improve the detection of the risk for development of atherosclerotic cardiovascular disease (ASCVD) with far higher precision than currently. In future research, the findings in this descriptive study may eventually be used as part of an age-adapted imaging-based screening for subclinical atherosclerosis.

The investigators hypothesize that a precision medicine-based approach to identify candidates likely to benefit from primary prevention against atherosclerosis, may improve medical decision making, by combining traditional risk factors, including lifestyle and psychological factors, phenotypic findings and findings on vascular imaging, and patterns of circulating biomarkers to identify risk of atherosclerosis especially in young individuals and at earlier disease stages (the ultimate population target of REACT project, phase II), maximizing the potential for prevention long before overt disease occurs. An essential aspect of this approach is to pinpoint the specific risk factors in each individual that primarily drive atherosclerosis throughout their life and could serve as therapeutic targets.

Thus, the overall purpose of this study is to establish the necessary knowledge, including extensive characterisation of atherosclerosis across life and thus add to the rational foundation for future development of a far more efficient and precise prophylaxis against ASCVD as compared with the presently applied methods.


Eligibility Criteria:
Inclusion Criteria:

* The study will include adults ≥18 to ≤70 years of age (1:1 sex ratio in each 10 years age strata).
* Have not been diagnosed with ASCVD prior to inclusion into the study (participants with other cardiovascular diseases or predisposing factors are not excluded).
* The participants will be recruited from sites in Denmark (n \~ 8,000) (and Spain (n \~ 8,000)).
* Participants need to be capable and be able to read and understand Danish, English, Spanish or Arabic.

Exclusion Criteria:

* The participants will be excluded from the CTA with contrast if they have severe renal disease (eGFR \<30 ml), contrast allergies, pregnancy or other conditions excluding the performance of a CT-scan.