cyrilzakka/clinical-trials huggingface dataset:
Gallium-68 Labeled Pentixafor PET/CT in Adrenal Masses

The CXC chemokine receptor type 4 (CXCR4), which is a G protein-coupled receptor expressed on the surface of the cell membrane, contributes to the development and progression of malignancies and functional endocrine disorders. CXCR4 expression has been reported to be upregulated in aldosterone-producing adenomas and cortisol-producing adenomas; however, its expression is almost negligible in non-functioning adrenal adenomas. Besides, CXCR4 is also hardly expressed by the tumor cells in paragangliomas. 68Ga-pentixafor, a CXCR4-specific PET tracer, may therefore be effective for the evaluation of the functional lateralization of adrenal lesion and identification of functional adrenocortical adenomas. In this pilot study, we aimed to develop 68Ga-pentixafor PET/CT as a noninvasive test for the recognition of functional adrenocortical lesions and to help guide the management of patients with suspicious adrenal masses.

Identifying the functional distinctions between adrenal nodules remains challenging. It is imperative to employ the least invasive approach for the functional evaluation of adrenal masses (e.g., adrenal venous sampling) without compromising efficacy. The conventional functional diagnosis protocol of adrenal masses is based on a combination of clinical symptoms, the presence of adrenal hormonal disorders, and radiographic features. However, the clinical manifestations of endocrine diseases are diverse, and a lack of uniformity in diagnostic protocols and assay methods for determining hormonal activation in adrenal disorders results in a significant variability in measurements. Besides, conventional imaging provides information of the morphology of a lesion, but not its functional status. Thus, an effective and non-invasive workup is needed for the characterization of adrenal masses and their therapeutic management.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent.
* Patients with adrenal diseases.
* A diagnostic computed tomography (CT) or magnetic resonance imaging (MRI) of the adrenal region within the previous 6 months prior to dosing day is available

Exclusion Criteria:

* Pregnant or breast-feeding women.
* Prior or planned administration of a radiopharmaceutical within 8 half-lives of the radionuclide used on such radiopharmaceutical including at any time during the current study.
* Any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude
Esthetic Evaluation of Onlay Restorations Constructed From Vita Ambria Glass Ceramics

There is limited data available on VITA AMBRIA glass ceramic , so this study is conducted to investigate the esthetic parameters of this new glass press system.

This study will be randomized, double blinded, 1:1 parallel group, superiority clinical trial. including two research groups; VITA AMBRIA ( intervention) and IPS e.max press( Comprator). The total subjects in this study are 50, recruited from the faculty' out patient clinic. 50 partial coverage indirect restorations will fabricated and cemented for each subject. Clinical evaluations will be conducted at baseline, 6, and 12 months of follow-up according to FDI World Dental Federation criteria by two independent evaluators. The primary outcome is examining the color stability and translucency.

Eligibility Criteria:
Inclusion Criteria:

Participants in this trial should be Healthy, between 18-50 years old, have normal occlusion, well aligned teeth, and good oral hygiene. Both sexes will be included. Participants should present with one or more of their posterior teeth having moderate-size coronal decay or old filling. The target teeth should be free from any signs and symptoms and should have complete root apex with no fracture as determined by the radiograph.

Exclusion Criteria:

Incapable of self-care, mental illness, undergoing radiotherapy, epilepsy, diabetic patient, pregnancy, allergy to one of the materials used, smokers, parafunctional habits, poor oral hygiene, severe periodontitis, teeth need surgical crown lengthening or marginal elevation, teeth with enamel discoloration or enamel/dentin hypoplasia or hypocalcification, Malaligned or malformed teeth and adjacent or opposing teeth are missed. Third molars and teeth need vital pulp therapy will also be excluded.
Ambulatory Blood Pressure and Prognosis

To continue a prospective study of the ability of ambulatory blood pressure to predict cardiovascular morbidity in patients with mild hypertension.

BACKGROUND:

This was a continuation of a prospective study of the ability of ambulatory blood pressure to predict cardiovascular morbidity in patients with mild hypertension, which was first started in 1978.

DESIGN NARRATIVE:

Predictor variables evaluated at entry to the longitudinal study included clinic and ambulatory blood pressures (including measures of pressure level and variability in different settings), left ventricular mass index (LVMI, determined by echocardiography), renin-sodium profile, and other cardiovascular risk factors (e.g., cholesterol and smoking). During follow-up, blood pressure, treatment status, BMI, and clinical course were evaluated. Outcome measures were definite cardiovascular morbid events, defined as sudden cardiac death, myocardial infarction, stroke, congestive heart failure, and coronary artery revascularization. The main hypotheses tested were that ambulatory blood pressure would give a better prediction of outcome than clinic pressure, and that patients with white coat hypertension (defined as a high clinic pressure and normal ambulatory pressure) would be at low risk relative to patients with sustained hypertension. Initial results in 729 patients initially studied between 1978 and 1985 using Cox survival analysis showed that the four most significant predictors of morbid events were daytime blood pressure variability, age, male sex, and serum cholesterol. Patients with white coat hypertension appeared to be at a level of risk intermediate between normotensives and sustained hypertensives, but the differences were not yet significant. Expansion of the cohort size to include patients evaluated initially between 1985 and 1990 provided nearly 2,000 patients altogether, which together with the longer follow-up of the initial cohort provided a sufficient number of morbid events to identify the predictive significance of the different blood pressure measures, and their interaction with other risk factors.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Computer-based Tutorial as Supportive Means to Enhance the Informed Consent Process for Cataract Surgery

To assess whether a computer-based tutorial as supportive means enhances quality and efficiency of the informed consent process for cataract surgery focussing on the patients' attitude before and after surgery.

Informing the patient and obtaining informed consent is one of the major duties physicians perform before starting a medical treatment. The requirements concerning the informed consent process are high. The amount of information needed to be explained to the patient is growing, as procedures get more complex and the number of treatment options increase.

The CatInfo tool is a computer-based tutorial about cataract and cataract surgery run on a handheld device with headphones and presented in an audio-visual fashion. The patient gives feedback after each chapter using a traffic light system to ensure that the content has been understood (green - content understood, ready to continue; yellow - questions that require discussion with the physician and red - repetition of the module required). A printout that summarizes what the patient has selected after each chapter immediately tells the physician which topics have been poorly understood or were unclear.

It has been shown in a randomized triple-masked study that patients using the CatInfo tool were significantly better informed than patients only having a face-to-face interview. Satisfaction with the tool was high. This present study has the goal to assess the patients' attitude before and after surgery using validated questionnaires (decisional conflict scale, decision regret scale) as well as knowledge. Patients scheduled for their first eye cataract surgery are randomly allocated to two groups, receiving standard face-to-face informed consent (control group) or additionally using the interactive CatInfo tool (study group). Scores between the groups are compared.

Eligibility Criteria:
Inclusion Criteria:

* Cataract
* Age 18 and older
* First eye to be operated
* No previous ophthalmic surgery
* written informed consent to participation in the study

Exclusion Criteria:

* Visual acuity of less than 0.1 Snellen in the worse eye
* Severe hearing loss
* Inability to use touch screen device (e.g. severe tremor, etc.)
Effect of the Cardio First Angle Device on CPR Outcomes

The investigators conducted a randomized, controlled, single-blinded study of patients undergoing CPR for cardiac arrest in the mixed medical-surgical ICUs of four academic teaching hospitals in Tehran, Iran from June 1 to October 31, 2014. Patients were randomized to receive CPR with either standard manual compression, or compression with real-time audiovisual feedback using the Cardio First Angel™ device.

The investigators sought to determine if the addition of a CPR feedback device to routine manual CPR would impact the quality and consistency of chest compression and patient survival. We conducted a randomized, controlled, single-blinded study of patients undergoing CPR for cardiac arrest in the mixed medical-surgical ICUs of four academic teaching hospitals. Patients were randomized to receive either standard manual CPR or CPR using the Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) feedback device. Recorded variables included return of spontaneous circulation, adherence to CPR guidelines and quality of CPR, nurse satisfaction and CPR associated morbidity.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Admitted to the intensive care unit (ICU)
* Full-code status
* Informed consent was obtained from the patient, legal guardian, or healthcare surrogate upon ICU admission (prior to cardiac arrest event)

Exclusion Criteria:

* Patients with any limitation of code status including but not limited to "no code" or"do not resuscitate" (DNR) and"do not intubate" (DNI), were excluded from study participation
Short-term Glucocorticoid Combined with MMF for IgG4-RD

Comparison of short-term glucocorticoid monotherapy and short-term glucocorticoid combined with MMF in the treatment of IgG4 Related Disease

This is a monocenter, 72-week prospective, randomized controlled study to compare short-term glucocorticoid monotherapy and short-term glucocorticoid combined with MMF in the treatment of IgG4 Related Disease.

Eligibility Criteria:
Inclusion Criteria:

1. 18-80 years old;
2. All patients must meet the comprehensive diagnostic criteria of IgG4-RD revised in Japan in 2020 or the classification criteria of IgG4-RD formulated by ACR/EULAR in 2019;
3. Active IgG4-RD (at least one organ has an IgG4-RD reaction score \>=2 at the time of enrollment.)；
4. No previous medication or recurrence after withdrawal.

Exclusion Criteria:

1. Combined with other autoimmune diseases as the main diagnosis.
2. Pregnant or lactating women
3. Patients with malignant tumor
4. Active bacterial, fungal, viral or mycobacterial infections.
5. Severe complications of important organs, and the expected survival time is less than 6 months.
Impact of Differential and Systematic Diagnosis of Dengue, Chikungunya and Malaria on Patient Management and Antibiotic Use in West Africa

The differential and systematic diagnosis of malaria, dengue and chikungunya in patients with fever (≥38.5°C) of undetermined etiology would allow the identification of infection by these pathogens and thus limit the inappropriate use of antibiotics (discontinuation or non-initiation) and optimize the clinical management and prognosis of patients.

The research hypotheses are as follows:

* Systematic diagnosis of malaria, dengue and chikungunya using diagnostic tests would improve the clinical management of patients with fever of undetermined etiology and reduce the misuse of antibiotics (discontinuation or non-initiation) and associated resistance.
* Improved management is associated with a reduction in the use of hospital resources, professional inactivity and an improvement in the quality of life and satisfaction of patients.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged ≥ 18 years
* Patient with fever (≥38.5°C) and at least two of the following symptoms in the last 10 days:

  * Severe headache
  * Retro-orbital pain
  * Muscle and joint pain
  * Nausea
  * Vomiting
  * Adenopathy
  * Rash
  * Abdominal pain
  * Asthenia
  * Spontaneous bleeding (purpura, epistaxis, haematemesis, etc)
* Willingness and ability to provide two 4 mL blood samples
* Willingness to provide one drop of blood per capillary sample
* Informed and signed consent

Exclusion Criteria:

* Subjects aged \< 18 years
* Pregnant women
* Breastfeeding women
* Patient's refusal to participate in the study
Trial of Tibial Nerve Stimulation for Treating Sexual Dysfunction

The purpose of this study is to understand the efficacy of PTNS versus a placebo in the treatment of female sexual dysfunction syndrome.

The goal of this study is to evaluate the efficacy of PTNS in treating patients with FSD. We will be recruiting 66 patients, who will be randomized (1:1) to either the PTNS group or the Sham group. The patients in the PTNS group will receive one PTNS treatment per week for 12 weeks. The patients in the Sham group will receive one sham treatment per week for 12 weeks. Patients in both groups will be asked to complete questionnaires before the start of the treatment, as well as after 12-weeks of treatment to assess the changes in the severity of their symptoms

Aim 1: To evaluate the effect of percutaneous tibial nerve stimulation (PTNS), compared to a validated sham, on sexual functioning in women with female sexual dysfunction (FSD).

Aim 2: To compare the effect of PTNS on lower urinary tract symptoms versus sexual functioning in patient with FSD.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 or older
* FSFI score of ≤ 26.55
* Patients must be sexually active within one month prior to the study and plans to continue to be sexually active for the next 12 weeks (Sexual activity can include masturbating, vaginal intercourse, caressing, and foreplay)

Exclusion Criteria:

* Patients with anatomical limitations preventing successful placement of the electrode (bleeding disorders, peripheral vascular disease, ulcers, or lower leg cellulitis)
* Patients with medical disorders precluding stimulation (cardiac pacemakers, current use of Holter monitor, known history of neuropathy)
* Pregnant women or women intending to become pregnant during the course of the study.
Assessment of Energy Balance

The primary purpose of this study is to test different methods of measuring energy balance, including food intake and energy expenditure. Another primary purpose of this study is to see if energy expenditure predicts weight and change after a weight loss diet. A secondary aim will be to test the reliability and validity of the Actical accelerometer, SenseWear Armbands, and the Intelligent Device for Energy Expenditure and Activity (IDEAA) monitors at measuring activity energy expenditure (AEE) and total daily energy expenditure (TEE) against the gold standard, doubly-labeled water (DLW). Similarly, we will test whether the estimated energy expenditure or posture allocation from the 3 devices is associated with weight change during and following a low calorie diet (LCD).

The study will take place over a period of one year. Participants will spend 3 weeks completing Phase I, and eight weeks completing Phase II (the weight loss phase of the study). Then, participants will return to the center at months 6 and 12 for a follow-up visit. During these visits, body weight, blood pressure, and pulse will be recorded, and questionnaires about eating attitudes and habits will be collected and assessed.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years
* Body Mass Index 25-40
* Willing to eat foods provided for two days.
* Willing to wear the IDEEA( Intelligent Device for Energy Expenditure and Activity), which is a device that attaches to the body and records movement and activity.
* Willing to wear an accelerometer, which is similar to a pager that attaches to belt or clothing and measures activity.
* Willing to use a cell phone equipped with a digital camera to take pictures of foods for one week.
* Willing to undergo an 8 week weight loss diet, consisting of supplement or powdered shakes, portion-controlled entrees, or home-cooked meals.

Exclusion Criteria:

* A diagnosis of diabetes, cardiovascular disease, or cancer.
* Females who are pregnant or planning to become pregnant during the trail.
* Medications that influence appetite or body weight (weight loss medications such as sibutramine, antipsychotic medications such as olanzapine, or herbal weight loss products) taken during the previous three months.
Intravascular Lithotripsy and/or Mechanical Debulking for Severely Calcified Coronary Artery Lesions

To evaluate intra-procedural and long-term effects of intravascular lithotripsy with the ShockWave System and/or non-balloon mechanical debulking devices, prior and/or after coronary stenting in an angiographically well-defined group of patients with complex calcified coronary artery lesions.

At present age, there are few real-world data published about the use of intravascular lithotripsy. Its safety and possible procedural complications remain unclear, and the effects of combination with other plaque-modification devices are unknown. Finally, there are few data about long-term outcomes in the real-life setting.

Subject Population: Subjects ≥ 18 years of age with de novo, calcified coronary artery lesions presenting with Stable CAD or Acute Coronary Syndromes, that are suitable for percutaneous coronary intervention (PCI). Approximately 400 subjects at 20 sites will be enrolled. Subjects will be followed through discharge, 30 days, 6 and 12 months

Eligibility Criteria:
Inclusion Criteria:

General Inclusion Criteria:

1. ≥18 years of age;
2. Native coronary artery disease suitable for PCI;
3. Patients with stable ischemic heart disease or unstable ischemic heart disease (Unstable Angina, Non-ST Elevation Myocardial Infarction, ST-Elevation Myocardial Infarction), patients with concomitant cardiogenic shock.
4. Patient or legally authorized representative, signs a written Informed Consent form to participate in the study, prior to any study-mandated procedures;

Angiographic Inclusion Criteria:

1. The target vessel reference diameter must be ≥2.5 mm.
2. De novo coronary lesions or calcific in-stent restenosis or suboptimal stent expansion in a severely calcified coronary segment: Unprotected or Protected Left Main, LAD, LCfx, Ramus, RCA.
3. Angiographic stenosis \> 70% or stenosis \> 50% and \< 70% with FFR \< 0.80 or iFR \< 0.90 or IVUS or OCT minimum lumen area ≤4.0 mm²;
4. Evidence of calcification at the lesion site: angiographic calcifications (Mintz el al Classification) are described as : None/mild, Moderate (radio-opacities noted only during cardiac cycle prior to contrast injection) severe calcification: radio-opacities seen without cardiac motion prior to contrast injection, usually affecting both sides of the arterial lumen.

Exclusion Criteria:

1. Patient is participating in another research study involving an investigational agent (pharmaceutical, biologic, or medical device) that has not reached the primary endpoint;
2. Patient is pregnant or nursing (a negative pregnancy test is required for women of child-bearing potential within 7 days prior to enrollment);
3. Patient has an allergy to imaging contrast media which cannot be adequately pre-medicated;
4. Patient has an active systemic infection on the day of the index procedure with either fever, leukocytosis or requiring intravenous antibiotics;
Compare Elbow mNT-BBAVF With Wrist RCAVF for Hemodialysis Access

Investigator plan to conduct a multicenter, open-labelled, randomized study to compare the primary patency and safety of elbow mNT-BBAVF and wrist RCAVF in hemodialysis patients.

Although wrist radiocephalic arteriovenous fistula (RCAVF) has been recommended as first preferred fistula in many clinical practical guidelines for vascular access, there are no randomized controlled trials (RCTs) comparing the recommended anatomic order of distal-to-proximal access construction up to now. A modified non-transposed brachiobasilic arteriovenous fistula (mNT-BBAVF) that has a long length of suitable superficial vein for cannulation and a sufficient blood flow for effective dialysis has been introduced by investigator for several years. In addition, mNT-BBAVF has good primary patency and a low risk of complication and leave opportunities for further procedures in the event of failure. Investigator plan to conduct a multicenter, open-labelled, randomized study to compare the primary patency and safety of elbow mNT-BBAVF and wrist RCAVF in hemodialysis patients.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with chronic kidney disease (CKD) stage 5 requiring hemodialysis (including pre-dialysis patients) and eligible for a native arteriovenous fistula;
2. Adult (age ≥ 18 years old);
3. Preoperative Doppler ultrasonography showing target vein diameter(s) ≥ 2.0 mm and target artery diameter(s) ≥ 2.0 mm;
4. Estimated life expectancy \> 1 year;
5. Written informed consent obtained;
6. Patient is free of clinically significant conditions or illness that may compromise the procedure within 30 days prior to AVF creation

Exclusion Criteria:

1. Patients with a history of cerebral hemorrhage or gastrointestinal hemorrhage are excluded from the study;
2. New York Heart Association class III or IV heart failure;
3. Patients who are absent of median cubital vein and verified by preoperative Doppler ultrasonography are excluded from the study;
4. Known central venous stenosis, central vein narrowing \> 50% or deep vein thrombosis based on imaging on the same side as the planned AVF creation;
5. Prior arm surgically created access in the planned treatment arm;
6. Immunosuppression (i.e. use of immunosuppressive medications to treat an active condition).
Body Image Disorder in Anorexia Nervosa and Virtual Reality

Evaluation of the tolerance and acceptability of the virtual representation of its body image.


Eligibility Criteria:
Inclusion Criteria:

* Women, aged between 16 and 40
* Post-puberty
* Pure restrictive anorexia nervosa, diagnosis by the DSM-V
* BMI \<17.5
* Patient attending an outpatient clinic at the Bohars Psychiatric Hospital in France
* Having signed the Informed Consent Form
* For minor patients, signing the form of informed consent of both parents

Exclusion Criteria:

* Associated eating disorder (bulimia, or the binge eating / purging form of anorexia nervosa),
* Psychiatric disorders (characterized depressed, anxiety disorder)
* Neurological Disorders
* Mental retardation
* Abuse or addiction to alcohol
* Abuse or dependence on psychoactive substances in the previous year.
* Patient with a protective justice measure
Demographic, Clinical and Laboratory Characteristics of Children With Alpha Thalassemia in Northern Israel

The study intends to summarize the clinical and laboratory characteristics of children with hemolytic anemia diagnosed as having alpha thalassemia mutations.

Fifty children and adolescents diagnosed as having alpha thalassemia will be studied, the clinical characteristics and hematology analysis will be summarized.

Eligibility Criteria:
Inclusion Criteria:

* All the patients that were studied at the pediatric hematology unit ant the Ha'Emek Medical Center

Exclusion Criteria:

* None