cyrilzakka/clinical-trials huggingface dataset:
A Multicenter Study of Iomeron®-400 Used With Multi-detector Computed Tomography Angiography (MDCTA)

This is a Phase IV multicenter, open-label study and is being implemented in order to assess diagnostic image quality of MDCTA in subjects undergoing computed tomography angiography (CTA) of the thoraco-abdominal aorta, and the carotid, pulmonary and peripheral arteries with IOMERON.

This is a Phase IV multicenter, open-label study and is being implemented in order to assess diagnostic image quality of MDCTA in subjects undergoing computed tomography angiography (CTA) of the thoraco-abdominal aorta, and the carotid, pulmonary and peripheral arteries with IOMERON. The hypothesis is that IOMERON used at a high concentration will provide good diagnostic image quality. The Investigators will also function as readers and evaluate the images on-site. Efficacy analysis will be based on the on-site evaluations.

Imaging conditions will be representative of those used in routine clinical practice. The study will be conducted at approximately 10-20 sites in China. Each site may enroll approximately 40 subjects in this study. Approximately 400 subjects will be enrolled in order to obtain 360 evaluable subjects who undergo elective MDCTA of the thoraco-abdominal aorta, or carotid, pulmonary or peripheral arteries.

Eligibility Criteria:
Inclusion Criteria:

1. Provides written Informed Consent and is willing to comply with protocol requirements
2. Is at least 18 years of age.
3. Is scheduled to undergo an elective thoraco-abdominal aorta, carotid, pulmonary or peripheral MDCTA examination.

Exclusion Criteria:

1. Is a pregnant or lactating female. Exclude the possibility of pregnancy:

   by testing on site at the institution (serum or urine βHCG) within 24 hours prior to the start of investigational product administration, by surgical history (e.g., tubal ligation or hysterectomy),post-menopausal with a minimum 1 year without menses;
2. Has any known allergy to one or more of the ingredients of IOMERON or a history of hypersensitivity to iodinated contrast agents;
3. Has moderate to severe renal impairment;
4. Has received an investigational compound and/or medical device within 30 days before admission into this study;
5. Has been enrolled previously to this study
6. Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.
PVE/PVL Combined With DEB-TACE in the Treatment of Patients With Large and Unresectable Liver Cancer

This is a multicenter, randomized, positive parallel controlled clinical study to evaluate the short-term and long-term efficacy and safety of PVL/PVE combined with DEB-TACE in the treatment of unresectable patients with large or large tumors in the right lobe of the liver.

Most guidelines recommend transarterial chemoembolization (TACE) as the standard of treatment for hepatocellular carcinoma（HCC）which is limited to the right half of the liver, single large or multiple, with / without tumor thrombus of the right branch of the portal vein.While a number of studies demonstrate poor effect of TACE for patients with large hepatocellular carcinoma. Portal vein embolization(PVE)/portal vein ligation(PVL) is the main means to increase the future liver remnant (FLR), which can reduce the complications after hepatectomy. TACE on the basis of PVE/PVL can not only increase FLR, but also can effectively control the progression of tumor by sequential TACE. This study intends to conduct a multicenter, randomized, positive parallel-controlled clinical study to objectively and scientifically evaluate the short-term and long-term efficacy and safety of ligation of the right portal vein combined with Drug-eluting bead transarterial chemoembolization(DEB-TACE) technique in the treatment of patients with large or large tumors of the right lobe who cannot be resected in I-stage.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed as large or giant hepatocellular carcinoma of the right lobe of the liver;
* Child-Pugh liver function grade A,
* ECOG PS 0-1
* If the tumor is resected with R0, the remaining liver volume is insufficient
* ICG-15R \< 30%
* No serious organic diseases of heart, lung, brain and other organs;
* No history of other malignant tumors;
* The patient's survival time is expected to be more than 3 months.

Exclusion Criteria:

* Pregnant and lactating women
* History of organ transplant
* Tumor thrombus with portal vein trunk or left branch involved;
* distant metastasis;
* Patients with obvious liver cirrhosis (Plt \< 100 × 10 \^ 9 / L at admission or gastroscopy suggested esophageal and gastric varices);
* Active bleeding caused by various causes;
* Suffering from severe acute or chronic diseases or infectious diseases;
* History of hepatectomy or TACE treatment.
Clinical Evaluation of the APTIMA® COMBO 2® Assay Using the PANTHER™ System

The objectives of this study are to establish the performance characteristics of the AC2 (APTIMA Combo 2) Assay on the PANTHER System for the sample types cleared for use on the TIGRIS and DTS (Direct Tube Sampling) Systems and to demonstrate the repeatability and reproducibility of the AC2 Assay on the PANTHER System.

The results of this protocol AC2PS-US11-001 (NCT01733069) are based on samples collected from protocol ACTPS-US10-001(NCT01358799).

The registration for NCT01358799 was withdrawn because the samples were not tested under protocol ACTPS-US10-001, instead they were tested under the protocol registered here AC2PS-US11-001 (NCT01733069).

Eligibility Criteria:
Inclusion Criteria:

•The subject is at least 14 years of age at the time of informed consent and is sexually active

* The subject reports symptoms consistent with a suspected STD (sexually transmitted disease) such as abnormal discharge, genital itching, pain/discomfort during sexual intercourse or urination, and/or lower abdominal discomfort.
* If the subject is asymptomatic, the subject is known to be partners with, or a contact of, a person with a confirmed or suspected STD(s), is undergoing screening evaluation for a possible STD(s), and/or is scheduled for a routine exam that may include a pelvic exam
* The subject and/or legally authorized representative is willing to undergo the informed consent process prior to study participation (a minor will need the documented consent of his/her parent or legal guardian, unless the site has an IRB (institutional review board) approved waiver for parental consent for minors)

Exclusion Criteria:

•A potential subject will be ineligible for clinical trial enrollment if the subject, clinician, or medical record reports any of the following:

* The subject took antibiotic medications within the last 21 days
* The subject is underage (as defined by the IRB (institutional review board) or state law), without the documented consent of her/his parent or legal guardian (exception: sites that have an IRBapproved waiver for parental consent for minors)
* The subject is determined by the investigator to be medically unsuitable for participation in this study (eg, medical history of concurrent illness that could result in an unacceptable risk to the subject) Concurrent participation in other clinical study(ies) may be acceptable, with approval by the investigator and sponsor.
Cognitive Impairments in Children With Epilepsy

Since the proportion of language and attentional difficulties in patients with epilepsy is recognized, both in the literature and in the clinical experience of practitioners, it is appropriate to propose a complete speech-language assessment of oral language and attention.This study investigates these impairments through the taking of specific tests.

The general objective of this study is to observe possible oral language and attention disorders in children with epilepsy, by age and etiology of epilepsy.

The objective of this work is to study therapeutic apheresis (including plasma exchange and immunoadsorption) among french neuropediatric tertiary centers and to prove that this treatment modality is effective and well tolerated in pediatric neurology diseases.


Eligibility Criteria:
Inclusion criteria:

The subjects should :

* Be at least 3 years old and at most 15 years old
* Be French speaker
* Be in a regular class
* Have a diagnosis of epilepsy

Exclusion criteria:

* Subjects schooled in IEM
* Subjects diagnosed with austim spectrum disorder
* Subjects with a motor or visual handicap
* Subjects with psychiatric disorders
Gastrectomy With or Without Drainage (ADiGe)?

Prophylactic use of anastomotic drain in upper gastrointestinal surgery has been questioned in the last 15 years but only small studies have been conducted. In 2015 a Cochrane meta analysis on four Randomized Controlled Trials (RCT) concluded that there was no convincing evidence to the routine drain placement in gastrectomy. Nevertheless the Authors evidenced the moderate/low methodological quality of the included studies and highlighted how 3 out of four came from Eastern countries. Despite the above mentioned limits, Enhanced Recovery After Surgery (ERAS) society published the guidelines for gastrectomy that strongly recommend, with high evidence level, to avoid routine use of drain in gastric surgery. After 2015 some other retrospective studies have been published, all with inconsistent results. Our objective is to perform a multicentre prospective trial in a large western cohort of patients to establish wether avoid routine use of anastomotic drain does not led to an increasing of postoperative invasive procedure.


Eligibility Criteria:
Inclusion Criteria:

* all consecutive patients that undergo total or subtotal gastrectomy with a curative intent, for histologically proven gastric cancer or esophago-gastric junction cancer Siewert type II or III, in surgical investigator centres from the beginning of the study until reaching the accrual number
* esophageal involvement \<= 2 cm
* patients undergoing upfront surgery or treated with a neoadjuvant/perioperative chemotherapy
* open, hybrid, laparoscopic or robotic approach
* all types of anastomosis (circular stapled, linear stapled, hand sewn)

Exclusion Criteria:

* refuse to sign informed consent
* age \<18
* Heart failure New York Heart Association (NYHA) class IV
* severe liver disease (Child \>= 7)
* pregnancy
* metastatic disease
* emergency surgery
* palliative surgery
* operation different from total or subtotal oncological gastrectomies (e.g. pylorus preserving, proximal gastrectomy)
* lymphnodal dissection \<D1
* reconstruction different from Roux-en-Y or Billroth II
* multiple organ resections (except for cholecystectomy)
* gastric cancer with duodenal involvement
* intraoperative Hyperthermic Intraperitoneal Chemotherapy (HIPEC)
How to Reduce Suicidal Thoughts and Impulsivity in Depression

The study aims at investigating if tDCS applied to left DLPFC or to right OFC to treatment as usual is effective in reducing severe suicidal ideas in major depressive episode.

Depressive disorders are one of the most frequent pathologies in psychiatry. The lifetime prevalence of the characterized depressive episode is indeed particularly high, between 16.6% in the United States and 24.1% in France. Because of this high prevalence, and because they constitute a pathology with a high risk of suicidal behavior (SC), depressive disorders are a major target of medical strategies for suicide prevention. In addition to suicidal ideation, impulsivity, considered as the tendency to express spontaneous, excessive and/or unplanned behaviors, is recognized as being a major factor precipitating SCs.

With a pilot, prospective, multicenter design, the perspectives of DEPIMPULSE include being able to develop an innovative therapeutic approach in the reduction of risky behaviors, in particular suicidal ideation, associated impulsivity, suicidal risk in patients suffering from depression, while improving our understanding of the behavioral aspects and associated cognitions.

The treatment will be delivered during 5 consecutive days (D1 to D5).

Baseline measures (D0) will be compared to those obtained after the treatment administration (last day of treatment (D5) and 2 weeks (+W2) and 1 month (+W4) after the end of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Man or woman older than 18 years oldRight-handed
* Signed Informed Consent form
* Subject affiliated to or beneficiary from a French social security regime
* Inpatient or outpatient at the Adult Psychiatry Service
* Diagnosis of Major Depressive Disorder according to the 5th edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria and confirmation by the MINI Structured Clinical Interview
* MADRS score ≥ 18
* Beck Scale for Suicide Ideation (BSS) score ≥8
* Under antidepressant treatment
* Absence of severe progressive neurologic and/or somatic pathologies (specially tumors, degenerative diseases)

Exclusion Criteria:

* tDCS contraindication
* Younger than 18 years old
* Left-handed
* under mood stabilizer and/or antiepileptic
* treated by ECT or rTMS or tDCS for the current eposide
* Subject under measure of protection or guardianship of justice
* Presence of other psychiatric pahtologies
* Subject beneficiary from a legal protection regime
* Subject unlikely to cooperate or low cooperation stated by investigator
* Subject not covered by social security
* Pregnant woman
* Subject being in the exclusion period of another study or provided for by the "National Volunteer File"
The Effects of Pelvic Floor Muscle Training in Women With Overactive Bladdder

The aim of our study is to investigate the effects of pelvic floor muscle training (PFMT) on pelvic floor muscle strength, sexual functions, bladder symptoms and quality of life in women with overactive bladder (OAB).

Overactive bladder (OAB) is defined by the International Continence Association as an "urgency with or without urge urinary incontinence, often accompanied by frequency and nocturia." Accordingly, pelvic floor muscle training (PFMT) plays an important role in the management of OAB. However, a recent systematic review suggests that PFMT is insufficient against OAB.

Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of overactive bladder
* Being volunteer

Exclusion Criteria:

* have a neurological disorder
* only those with stress urinary incontinence
* presence of advanced pelvic organ prolapse (stage 3-4)
* Having a mental problem that will prevent cooperation in evaluation and / or applications
* Women with the presence of malignant condition
Nutritional Intake and Bone Health in Celiac Disease

Celiac disease leads to malnutrition and secondary conditions including osteoporosis. The dietary habits of adults with untreated, undiagnosed celiac disease has not yet been observed, but presents a critical piece in understanding the effects of the disease on bone health. Objective was to evaluate differences in nutritional intake of calcium, vitamin D, and phosphorus; serologic indices of these nutrients; and bone health among adults with and without celiac disease. Cross-sectional data from What We Eat in America (WWEIA) and the National Health and Nutrition Examination Survey (NHANES) 2009-14 was analyzed.

Celiac disease leads to malnutrition and secondary conditions including osteoporosis. The dietary habits of adults with untreated, undiagnosed celiac disease has not yet been observed, but presents a critical piece in understanding the effects of the disease on bone health. Objective was to evaluate differences in nutritional intake of calcium, vitamin D, and phosphorus; serologic indices of these nutrients; and bone health among adults with and without celiac disease.

Cross-sectional data from What We Eat in America (WWEIA) and the National Health and Nutrition Examination Survey (NHANES) 2009-14 was analyzed, including self-reported dietary and supplement intake from one day of 24-hour recalls, serologic indicators, and dual x-ray absorptiometry (DXA) scans were analyzed in adults (n=49) testing positive for celiac disease to the tissue transglutaminase endomysial antibody assay (tTG-EMA). Statistical analysis included multiple linear regression modelling controlled for age, sex, race/ethnicity, energy intake, and poverty income ratio.

Eligibility Criteria:
Inclusion Criteria:

Adults aged 18+ years with a complete 24-hour recall in WWEIA and a completed celiac disease serologic test. Two groups were used in the analysis. The control group consisted of a normal adult population without celiac disease, as indicated by a negative serologic test for celiac disease and no self-reported celiac disease. The serologically positive group were considered to have undiagnosed, untreated celiac disease based on a positive serologic test for celiac disease (EMA+), no self-reported celiac disease, and no adherence to a gluten-free diet. NHANES employs two steps of serologic tests for selected participants to screen for celiac disease antibodies that develop as a T-cell-mediated response to gluten.

Exclusion Criteria:

* Adults were excluded if they were pregnant or breastfeeding at the time of the study, or if they reported any history of celiac disease.
Feedback, Motor Sequence Learning, and Brain Connectivity

Feedback delivered during motor practice can help promote motor skill learning, enhance confidence, and alter brain connectivity. However, the optimal way to provide feedback to promote learning, confidence and brain connectivity is unknown. This project will study how the feedback that is provided during practice of a movement skill can help people learn and build confidence and whether these correspond to changes in brain function. The investigators will measure motor skill performance, confidence, and resting state brain connectivity before and after a session of motor practice.

Positive social comparative feedback, which indicate to the learner that they are performing above average, is one way to enhance a learner's expectancies about future performance. Expectancies include the learners' perceived competence about their ability to perform the task, expectations about task outcome (success or failure), and predictions of extrinsic reward or positive experiences related to performance. Positive feedback during motor practice enhances expectancies, which is hypothesized to be rewarding to the learner, leading to better skill performance and learning. Reward is a powerful shaper of behavior. However, while social comparative feedback supports motor skill learning, it is unclear whether positive social comparative feedback induces a response in the dopamine reward network. Therefore, the purpose of this study is to determine the effects of social comparative feedback during motor practice on the functional connectivity of the reward neural network. The study aims to recruit 40 participants who will be randomized into 1 of 2 feedback groups (performance feedback or performance plus positive feedback). Participants will practice a motor sequence task on a single day and then return for retention performance testing about 24 hours later. Measures of brain function and brain structure will be collected before and after practice on day 1. Changes in performance (response time to complete a sequence) and self-efficacy will be measured from baseline to 24 hours later at retention. Changes in brain functional connectivity over practice on day 1 will be assessed in the reward network and the motor network.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 40 years
* Right-hand dominant

Exclusion Criteria:

* Medical diagnosis or medication that affects dopamine (e.g. dopamine reuptake inhibitors)
* Musculoskeletal issues that limit upper extremity movement
* Contraindications for magnetic resonance imaging (MRI)
Effectiveness of Physical Therapy in Stem Cell Transplant Recipients for Knee Osteoarthritis

Knee osteoarthritis has been considered as 11th highest contributor factor to nonfatal burdens in the world. It is considered one of the most common degenerative diseases of synovial joint and major cause of muscle impairment with limited functional activities. Recent efforts to investigate the possibility of stem cell therapies in the treatment of symptomatic osteoarthritis have seen an increase in interest in regenerative medicine, fueled a better understanding of the role of mesenchymal stem cells. Knee osteoarthritis is mostly managed by physical therapy, focused on managing pain, increasing the restricted range of motion and muscle strengthening. Therefore, the hypothesis is that combining both treatments will be beneficial for patients. The aim of this randomized controlled trial is to evaluate the effectiveness of physiotherapy in mesenchymal stem cell recipient in improving pain, quadriceps muscle strength and functional status of knee osteoarthritis patients.

A single blinded RCT will be conducted at Ortho Stem Cell Department, AlKhaleej Clinics. Collection of data will be started after the scientific and ethical approval from Dow University, Karachi. After screening by physician and fulfilling the inclusion and exclusion criteria, patients (n=48) will be enrolled. After briefing about the objectives and obtaining formal consent, data will be collected. Participants will be randomized and equally distributed into two groups i.e., twenty-four in control group '1' and twenty-four in treatment group '2'. The control group '1' will receive forward walking in home program after mesenchymal stem cell treatment while the treatment group '2' will be receiving quadriceps isometric exercise, straight limb raises (SLR), hip isometric adductor, knee terminal extension, semi wall squat, quadriceps drill exercises for knee osteoarthritis after mesenchymal stem cell therapy. Treatment plan will be of 8 weeks with 3 sessions in one week for 30 minutes. A physical therapist will do the assessment at baseline and at the end of treatment, other than the principal investigator to measure outcomes by using KOOS score, manual muscle testing and VAS scale. For the completion of the study 6 months are required after synopsis approval.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of age 40 years and above.
* Male and female both will be included.
* Patients with single or both knee OA.
* Patients who had mesenchymal stem cell transplantation.
* Kellgren and Lawrence grade II, III on radiological findings.

Exclusion Criteria:

* Patients with any neurological disorder.
* Any musculoskeletal deformity (varus/valgus).
* Patients who have had any type of lower limb internal fixation.
* Patients who have had any type of lower limb arthroplasty or other knee surgery in the past.
* Patients with a history of any infectious or malignant condition.