cyrilzakka/clinical-trials huggingface dataset:
Homeostatic and Non-homeostatic Processing of Food Cues in Anorexia Nervosa

The goal of the present study is to investigate metabolic gut-brain signaling and the neural correlates of distraction from visual food cues in patients with Anorexia nervosa and healthy controls.

Anorexia nervosa (AN) is an eating disorder with high morbidity and lifetime mortality. This eating disorder is mainly characterized by restricted food intake despite a severely low body weight. Given the pronounced self-starvation in AN, the investigation of homeostatic food processing, and its interaction with the reward system is of great scientific interest. Previous research in AN patients has almost exclusively focused on cortical, non-homeostatic (e.g., reward related) food processing. Therefore, the primary aim of the present study is to investigate metabolic gut-brain signaling by focusing on the responsivity of the hypothalamus (i.e., the core region of homeostatic control) and the mesocorticolimbic reward system. A secondary aim is to study the interaction between the mesocorticolimbic reward system and the homeostatic (i.e., hypothalamus) system. Metabolic gut-brain signaling will be assessed by applying a single-blind, randomized, crossover design of intragastric infusion of glucose or water. This approach allows the study of gut-brain signaling to the hypothalamus and the reward system by controlling for sensory aspects of food intake (sight, smell, and taste) in AN patients and healthy controls. Furthermore, we will measure how cognitive strategies to control the desire for visual food cues (top-down control) affect the mesocorticolimbic and hypothalamic systems in AN patients differently than in healthy controls. The interaction between the hypothalamus and the mesocorticolimbic reward system will be investigated using an effective connectivity analysis. Functional magnetic resonance imaging with high spatial resolution and with an optimized protocol for the investigation of the hypothalamus and the mesocorticolimbic reward system will be used to study for the first time homeostatic and non-homeostatic food cue processing in AN patients.

Eligibility Criteria:
Inclusion Criteria:

* patients that meet the diagnostic criteria for AN (DSM-V criteria)
* Medically stable patients with a BMI \< 17.5 kg/m² and \> 13 kg/m²; Healthy controls with a BMI \<25 kg/m² and \>18.5 kg/m²
* Over Age of 18 years
* no other lifetimes or current medical illness that could potentially affect appetite or body weight
* right-handedness
* normal or corrected-to-normal vision

Exclusion Criteria:

* history of head injury or surgery
* history of neurological disorder
* severe psychiatric comorbidity (psychosis, bipolar disorder, substance abuse)
* smoking
* borderline personality disorder
* current psychotropic medication
* inability to undergo fMRI scanning (e.g. metallic implants, claustrophobia, Pacemakers)
* pregnancy
Clinical and Biological Markers of Response to Cognitive Behavioural Therapy for Depression

The purpose of this study is to locate clinical markers (for example, interviews, questionnaires, and computer tasks) and biological markers (for example, physiological, blood-based, or electroencephalography measurements) that predict response to cognitive behavioral therapy for depression.

Forty adult outpatients with major depressive disorder or persistent depressive disorder will receive up to 20 sessions of cognitive behavioral therapy for depression over 16 weeks. Participants will complete clinical measures (interviews, questionnaires, and computer-based tasks) and biological measures (blood tests, physiological measurements, electroencephalography ) before, during, and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Major Depressive Disorder or Persistent Depressive Disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition
* Must be fluent in English
* Must be capable to give informed consent

Exclusion Criteria:

* Lifetime diagnosis of Schizophrenia, Schizoaffective Disorder, Bipolar Disorder
* Current Alcohol or Drug Use Disorder (except tobacco or caffeine)
* Current psychotic symptoms
* Acute suicide risk
* Psychological treatment for depression initiated during the past three months
* Pharmacological treatment for depression initiated/changed during the past three months
* Previous non-response to two or more adequate trials of pharmacotherapy
* Current significant neurological disorder, head trauma, or unstable medical conditions.
Denosumab (AMG 162) in Bisphosphonate Naive Metastatic Breast Cancer

This study is to evaluate various doses and schedules for denosumab administration and characterize the safety profile in this indication.


Eligibility Criteria:
Inclusion Criteria: - Histologically or cytologically confirmed breast adenocarcinoma

* At least one bone metastasis
Spartan Cube CYP2C19 Method Comparison Study

The aim of the study is to demonstrate concordance (percent agreement) between results produced by the Spartan CYP2C19 system and bi-directional sequencing. In addition, this study will evaluate the concordance of buccal samples stored prior to running on the Spartan Cube CYP2C19 system and bi-directional sequencing.

Sample holding time - two parts

1. Sample tested in less than one-hour

   a.In the first part, buccal samples will be collected from subjects and tested using the Spartan Cube CYP2C19 system. These samples will be run immediately (within 1 h) after collection from the subject (\<1 h sample holding time). All results will be compared to bi-directional sequencing to determine percent agreement.
2. Sample tested greater than 21 hours a.In the second part (sample holding portion), samples will be tested using the Spartan Cube CYP2C19 product. These samples will be run after storage at ambient temperature. All results will be compared to bi-directional sequencing to determine the percent agreement.

Eligibility Criteria:
Inclusion Criteria:

* Participants who will provide buccal samples and a saliva sample who have not eaten drank or smoked in the past 30 minutes.

Exclusion Criteria:

* Participants who have eaten drank or smoked in the past 30 minutes prior to collection.
Evaluation of the Safety and Efficacy of Ketotifen 4.0% Patch as Compared to Placebo Patch, Olopatadine 0.2% Ophthalmic Solution, and Artificial Tears in the Conjunctival Allergen Challenge (CAC) Model of Acute Allergic Conjunctivitis

This is a phase 2 study that will consist of 4 visits over a 5 week period. Drug will be evaluated using the conjunctival allergen challenge model of allergic conjunctivitis.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age of either sex and any race
* positive history of ocular allergies and a positive skin test reaction to cat hair, cat dander, dog dander, grasses, ragweed, trees, dust mites, and/or cockroaches within the past 24 months
* able and willing to avoid all disallowed medication for the washout period and during the study

Exclusion Criteria:

* active ocular infection or skin condition
* ocular surgery within the past 3 months
* pregnancy or nursing
The Added Value of DBT Over Mammography in Local Tumor Staging in Patients With BIRADS 4 or 5 Lesions

Compare the diagnostic accuracy of tomosynthesis with 2D mammography in cases with suspected BI-RADS 4 or 5 to determine its potential benefit for staging

Digital breast tomosynthesis (DBT) is a promising 3D imaging technique for breast imaging that use in breast cancer detection. it acquires reconstructed volume data , the data is reconstructed secondarily in mammary slices from several radiographs acquired from different angles of view (-15◦ to +15◦ for Fuji). It theoretically improves the sensitivity of detection by enabling enhanced delimitation of the lesion margins, and the specificity by avoiding the problem of glandular superimposition, By separating overlapping breast tissues \& it enhances detection of abnormalities located in different planes. DBT has higher breast cancer detection rates and lower recall rates compared with digital mammography (DM). There is also evidence of the diagnostic efficacy of DBT in women with clinical symptoms and women with screen-detected findings who have been recalled for work-up. Consequently, recommendations have been made about the role of DBT in screening asymptomatic women according to their risk levels, in evaluation of symptomatic women, and in work-up of suspicious DM findings. The main objective of this study was to compare tomosynthesis with 2D mammography in cases with suspected BI-RADS 4 or 5 anomalies, to determine its potential benefit for staging.

Eligibility Criteria:
Inclusion Criteria:

1. BI-RADS 4 OR 5 LESION that pathologically proved to be breast cancer.
2. No history of previous operations
3. No history of chemotherapy or radiotherapy

Exclusion Criteria:

1. BI-RADS 1 ,2,3 lesions
2. History of previous operation
Effect of Beraprost Sodium (Berasil) on Hemodialysis

There is no randomized control study to determine if the beneficial effects of beraprost sodium could improve the patency of arteriovenous fistula in hemodialysis patients. Therefore, this study is aimed to demonstrate the use of beraprost sodium can improve the patency of arteriovenous fistula in patients undergoing hemodialysis. This study is prospectively randomize controlled open-label trials in patients who newly made artificial arteriovenous fistula for hemodialysis. This study is a pilot study, and the target number of subjects is 60 in total, 30 in the treatment group and 30 in the control group.

After randomization, the treatment group takes a beraprost sodium for 6 months and the control group does not take placebo.

Treatment lasts for 6 months after dosing but continues until the patient changes the renal-replacement therapy method or falls under the exclusion criteria.

The patient should visit at 1, 3, and 6 months after arteriovenous graft surgery to check the access site after graft surgery. The doppler ultrasound test is performed to measure the access blood flow rate and patency of arteriovenous fistula.

This study is a prospective randomized controlled open-labeled trial of patients undergoing hemodialysis under the diagnosis of end stage renal disease. The subjects were divided into the treatment group and the control group through random assignment under the condition of receiving hemodialysis steadily and followed up for 6 months. After randomization, the treatment group received beraprost sodium (Berasil) for 6 months (24 weeks) and beraprost sodium will be provided by Astellas Pharma Korea, Inc. Patients were randomly assigned within 2 days after successful arteriovenous graft surgery, and the treatment group started taking 120 mcg of Berasil, while the control group did not take placebo to replace beraprost sodium.

Eligibility Criteria:
Inclusion Criteria:

* Patients who meet all of the following criteria

  1. Patient who newly made artificial arteriovenous fistula for hemodialysis
  2. Patients who agree to participate in the test and sign a consent form
  3. Patients who had diabetes

Exclusion Criteria:

* Patients under 18 years old, 80 years old or older
* Patients with a high risk of bleeding (hemophilia, capillary weakness, upper gastrointestinal bleeding, urinary tract bleeding, hemoptysis, vitreous hemorrhage, etc.)
* Women who are pregnant or have a possibility of pregnancy
* Platelet count ≤ 75000
* Patients taking anticoagulants or antithrombotics
* Patients with galactose intolerance, lactase deficiency or glucose-galactose malabsorption
DELTA Trial: Does Embolization With Larger Coils Lead to Better Treatment of Aneurysms Trial

Endovascular treatment with platinum coils is safe and effective in preventing rebleeding of intracranial aneurysms. Unfortunately, endovascular treatment of aneurysms with coils has been associated with incomplete occlusion at initial treatment (remnant) or at follow-up (recurrence). This in some studies has been as high as 20%. While many such aneurysm remnants or recurrences exhibit benign behavior, many require retreatment to prevent future hemorrhage.

A recent randomized controlled trial of aneurysm coiling revealed that aneurysms between 2 and 9.9 mm diameter were more likely to have an improved angiographic and composite clinical outcome when treated with hydrogel-coated coils, an improvement inferred to result from higher packing density afforded by hydrogel expansion(1). The use of hydrogel coils is associated with technical difficulties related to expansion and limited time for deployment. The investigators theorize that similar results could be achieved by using more voluminous bare platinum coils, leading to improved packing density compared to smaller caliber coils, and thus result in lower incidence of remnants or residuals. The relationship between packing densities and composite clinical endpoints having never been shown in a robust fashion, the investigators therefore propose a randomized clinical trial opposing coiling with soft 15-caliber coils to 10-caliber bare platinum coils in aneurysms varying in size from 3 to 9.9 mm.

To test the hypothesis that 15-caliber coiling systems are superior to standard 10-caliber coils in achieving better composite outcomes, the investigators propose the DELTA trial: Does Embolization with Larger coils lead to better Treatment of Aneurysms trial, a randomized controlled blinded trial with 2 subgroups of 282 patients each, 564 total:

Subgroup 1: Coiled with a maximum proportion of 15-caliber coils as conditions allow Subgroup 2: Coiled with 10-caliber coils.


Eligibility Criteria:
Inclusion Criteria:

* At least one ruptured or unruptured aneurysms with a dimension ≥ 10 mm (longest axis)
* for ruptured lesions, patients should be in World Federation of Neurosurgical Societies (WFNS) grade \< IV.
* The anatomy of the lesion is such that endovascular treatment is possible with both types of coils (not necessarily certain or probable)
* Patient is 18 or older
* Life expectancy is more than 2 years (able to complete follow-up)

Exclusion Criteria:

* Patients with planned treatment of an associated cerebral arteriovenous malformations
* When parent vessel occlusion, without simultaneous endosaccular coiling of the aneurysm, is the primary intent of the procedure
* Any absolute contraindication to endovascular treatment, angiography, or anaesthesia such as severe allergies to contrast or medications
Indirect Assessment and Intervention for Perinatal Drug Use

The purpose of this study is to assess the validity of an indirect computer-delivered screener for drug use and assess the efficacy of a computer-delivered brief intervention with urban post-partum women at-risk for substance abuse and HIV during the post-partum period.

Two factors limit the potential of brief interventions for the reduction of substance abuse and HIV risk. First, the ability to conduct such interventions is dependent upon willingness to disclose drug use and risky sexual behaviors. This is a significant obstacle given evidence that as few as half of drug-positive individuals-particularly women in the perinatal period-report that use. Second, there are logistic and financial obstacles to implementing even brief intervention programs, particularly with regard to time, training and provider willingness. In response to these limitations, and with NIDA support (DA018975), the Parent Health Lab at the Wayne State University School of Medicine developed and validated a sensitive indirect screener that evaluates correlates of illicit drug use rather than drug use itself. The Lab also developed a brief computer-delivered intervention designed to build change motivation without presuming the presence of risks to accompany the screener. This intervention demonstrated excellent feasibility and acceptability in Phase I testing. Following NIDA's Stage Model of Behavioral Therapy Development, the proposed study will take the next step of validating the computer-delivered indirect screening and intervention process in a Phase II/Stage IIb trial with women determined to be at risk by the indirect drug use screener. In addition, given that 47.8% of the prior sample's participants had an STI at some point in their lives, the proposed study will also further expand the existing focus on HIV risk. Specifically, we plan to: (a) continue development and validation of the WIDUS screener via concomitant collection of WIDUS protocols and hair/urine samples, as well as by building its ability to indirectly predict HIV risk; (b) revise and upgrade the draft indirect intervention based on expert and participant informant feedback; (c) recruit 500 at-risk women from an urban obstetric hospital; and (d) randomly assign participants into intervention and control conditions, with blinded follow-up assessments at 3- and 6-months. If proven efficacious, this logistically feasible, replicable, and low-cost approach could allow a dramatic increase in the reach--and therefore the population impact--of brief interventions for drug use among at-risk post-partum women. Further, any impact on maternal drug use would be further multiplied by indirect effects on the at-risk child.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* able to communicate in English
* recently gave birth to healthy infant

Exclusion Criteria:

* received narcotic pain medication in past 3 hours
* no sleep since giving birth
* infant deceased or in intensive care
* psychosis or other clear cognitive impairment
Adjuvant Tislelizumab Plus Lenvatinib for Patients at High-risk of HCC Recurrence After Curative Resection or Ablation

Though hepatic resection and ablation are the curative treatments for patients with hepatocellular carcinoma (HCC), the 5-years recurrence-free survival is lower than 30%. In recent years, several immune checkpoint inhibitors have been approved in advanced or unresectable HCC. No study about the safety and efficacy of adjuvant immune checkpoint inhibitors for patients with HCC after hepatectomy is reported.

Hepatic resection and ablation are the best treatments for patients with early stage hepatocellular carcinoma (HCC) or selected intermediate or advanced disease. However, the postoperative 5-years recurrent rate is up to 70%, for whom recurrence is a major cause of death. In recent years, several immune checkpoint inhibitors have been approved in advanced HCC by official guidelines. At the same time, four randomizead controlled trials about adjvuant immune checkpoint inhibitors for postoperative HCC are ongoing. A prospective cohort study found adjuvant immune checkpoint inhibitors with or without tyrosine kinase inhibitors may improve recurrence-free survival of patients at high-risk of HCC recurrence after curative resection (DOI: 10.1200/JCO.2023.41.16_suppl.4119. Journal of Clinical Oncology 41, no. 16_suppl. 4119). Therefore, the investigators plan to compare the safety and efficacy of adjuvant Tislelizumab plus lenvatinib to Tislelizumab monotherapy for patients with high-risk factor of HCC recurrence after curative resection and ablation in a multicentric, prospective study.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 75 years (inclusive);
* Diagnosis of HCC confirmed by postoperative histopathology;
* Underwent curative resection, as defined based on intra- and postoperative criteria;
* With high-risk factors of recurrence after curative treatment, based on preoperative radiological imaging or pathology reports indicating a tumor at least 5 cm in diameter, micro- or macrovascular invasion (Vp1/Vp2), satellite or multinodular tumors, and/or Grade 3/4 pathology;
* No residual cancer detected by radiological imaging in the liver within 8 weeks after curative resection;
* Child-Pugh 5-7 scores liver function;
* Eastern Cooperative Oncology Group performance status of 0 or 1.

Exclusion Criteria:

* Received neoadjuvant immune checkpoint inhibitors or tyrosine kinase inhibitors before resection or ablation;
* A history of other malignancies;
* History of active autoimmune or immunodeficiency diseases;
* Concurrent cardiac, pulmonary, cerebral, or renal dysfunction;
* Loss to follow-up within six months.
Validity and Reliability of the PhysioMaster Application in Measuring Wrist Range of Motion (ROM) Among Healthy Adults

The Universal Goniometer (UG) is a well-established tool for measuring joint range of motion (ROM). However, it presents limitations, including dependence on examiner skill, which can introduce error. With advances in digital technology, smartphone-based applications, such as PhysioMaster, now offer an alternative approach that potentially reduces human error and increases measurement precision

Measuring Wrist ROM Using the electronic Goniometer

The following protocol will be implemented to measure wrist ROM for the enrolled female participants:

Wrist Flexion-Extension Testing Position: Elbow flexed at 90 degrees, with the wrist positioned over the edge of a table and the forearm in full pronation.

Goniometer Axis: Lateral placement over the triquetrum. Stationary Arm: Aligned with the lateral midline of the ulna, directed toward the olecranon process.

Moving Arm: Aligned with the lateral midline of the 5th metacarpal. Wrist Radial-Ulnar Deviation Testing Position: Elbow flexed at 90 degrees, wrist positioned over the edge of a table with the forearm in full pronation.

Goniometer Axis: Positioned over the dorsal capitate. Stationary Arm: Aligned with the dorsal midline of the forearm. Moving Arm: Positioned parallel to the longitudinal axis of the third metacarpal (Surangsrirat et al., 2022).

Measurement using the smartphone inclinometer-based application For measurements using the smartphone inclinometer application, the smartphone was placed on the participant's wrist, with elbows and upper arms positioned against a wall and flat along their torsos for each movement. This standardized setup ensured consistent smartphone positioning across all ROM measurements .

Eligibility Criteria:
Inclusion Criteria:

- A sample of 30 female participants, aged 19 to 50 years, was selected for this study. Inclusion criteria required participants to be within this age range

Exclusion Criteria:

* any wrist pain, rheumatoid conditions, trauma, prior hand surgeries, deformities in either hand, or pregnancy
Effect Of A Treatment Optimization Program To Improve Satisfaction With Viagra

This study will demonstrate if a treatment optimization program has an impact on the satisfaction with Viagra treatment in men with erectile dysfunction


Eligibility Criteria:
Inclusion Criteria:

* Male subjects above age of majority for whom sildenafil is prescribed for the first time within the usual practice of medicine

Exclusion Criteria:

* Male subjects who have used any ED medical treatments over the last month, with the exception of testosterone and/or herbal therapies
* Subjects who do not have the possibility of viewing the video either through a computer, VCR or a DVD