cyrilzakka/clinical-trials huggingface dataset:
IRDye800CW-BBN PET-NIRF Imaging Guiding Surgery in Patients With Lower Grade Glioma

This is an open-label positron emission tomography/near infrared (PET/NIRF) study to investigate the imaging navigation performance and evaluation efficacy of dual modality imaging probe 68Ga-BBN-IRDye800CW in patients with lower grade glioma. A single dose of 40μg/111-148 Mega-Becquerel (MBq) 68Ga-NOTA-BBN and 1.0- or 2.0- mg/ml IRDye800CW-BBN will be injected intravenously before the operation and intraoperative respectively. Visual and semiquantitative method will be used to assess the PET images and real-time margins localization for surgical navigation.

Lower grade gliomas (WHO grades II and III) are currently diffused disease with variability of tumor behaviors and of challenge to distinguish the margins in white-light microscope during the surgery. An integrated dual-modality approach combining preoperative positron emission tomography imaging with intraoperative optical guidance that target the same tumor biomarker would be of grade help to solve this problem. BBN, with the amino acid sequence of Gln-Trp-Ala-Val-Gly-His-Leu-Met-NH2, has been extensively used for the development of molecular probes for the imaging of gastrin-releasing peptide receptor (GRPR), a member of the G protein-coupled receptor family of bombesin receptors that over-expressed in various types of cancer cells including glioma. For interests in clinical translation of GRPR targeting dual modality probe, an open label dual modality imaging PET/ NIRF study was designed to investigate the imaging guiding performance in lower grade glioma patients. To investigate whether the preoperative PET with BBN can predict the success of the fluorescence guided surgery with same peptide intraoperatively. The sensitivity, specificity and accuracy of fluorescence guided sampling intraoperatively according to the final pathology will be assessed as well.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to provide a written informed consent
* suspected lower grade gliomas on contrast-enhanced MRI

Exclusion Criteria:

* Consisted of conditions of mental illness
* Severe liver or kidney disease with serum creatinine \> 3.0 mg/dl (270 μΜ)
* Any hepatic enzyme level 5 times or more than normal upper limit
* Severe allergy or hypersensitivity to IV radiographic contrast
* Claustrophobia to accept the PET/CT or PET/MRI scanning
* Pregnancy or breast feeding
Distribution of Smooth Muscle In Dartos In The Non Conspicuous Penis

Non-conspicuous penis (congenital megaprepuce, occult penis) is a symptomatic malformation that includes phimosis and excessively baggy, urine-filled prepuce with alteration of the appearance of the penis. A redundant and enlarged foreskin is the main feature of this entity.This congenital anomaly is difficult to diagnose and may have association with other pathologies such as buried penis.

Currently, part of the megaprepuce skin is used to correct the defect. A recent study shows that patients with this pathology and hypospadias present mostly defects in the muscle dartos. The investigators do not know the physiological bases of the megaprepuce, neither the clinical and aesthetics implications of this abnormal tissue for the patient, and how this affects the postoperative evolution. With the present study the investigators intended to answer these questions and to open paths for future research in this area.

After informed consent, patients will be labeled with a research record number other than the identity document or the number of the attention. The urologist who perform the correction of the megaprepuce, will take a segment of the dartos and send it for histopathological analysis: staining with hematoxylin-eosin, smooth muscle actin marker, associated with the research record number. Same procedure will be performed with the controls and hypospadias group. Only the principal investigator will know the assignment of medical record and their respective group (congenital megaprepuce, hypospadias or controls). The samples will be sent to pathology without any clinical data, and they will be analyzed by two pathologists, both blind.

Eligibility Criteria:
Inclusion Criteria:

* Male patients scheduled for correction of congenital megaprepuce
* Male patients scheduled for correction of hypospadias
* Male patients scheduled for circumcision for non-medical reasons.

Exclusion Criteria:

* Patients with a history of hypospadias correction.
Strategic Ingestion of Creatine Supplementation and Resistance Training in Trained Young Adults

Creatine supplementation improves measures of muscle accretion and performance compared to placebo during a resistance training program. However, the optimal creatine supplementation protocol for maximizing these improvements is unknown.

Creatine is a naturally occurring nitrogen containing compound endogenously produced in the body through reactions involving the amino acids arginine, glycine and methionine. Alternatively, creatine can be consumed in the diet (primarily from red meat and seafood) or through commercially manufactured creatine. It has been proposed that the strategic ingestion of creatine supplementation may be an important factor to consider during a resistance training program to increase muscle growth and performance. There is evidence that creatine supplementation only on training days has greater muscle benefits compared to placebo in healthy older adults. However, the effects of creatine on training days (compared to creatine on non-training days or placebo) in healthy young adults is unknown. Further, pre- and post-exercise creatine supplementation appears to produce similar muscle benefits (compared to placebo) in healthy older adults. It remains to be determined whether the timing of creatine ingestion (immediately before vs. immediately following training sessions) influences the physiological adaptations from resistance training compared to placebo in young healthy adults. It is also unknown whether differences exist in supplementing with creatine immediately before, during or immediately following resistance training sessions in young healthy adults.

Eligibility Criteria:
Inclusion Criteria:

* Physically active (performing structured resistance training \> 2x/week for ≥ 4 weeks)
* Males and females (age 18-39)

Exclusion Criteria:

* Pregnant or nursing
* Have consumed creatine monohydrate within 30 days prior to the start of the study
* Pre-existing allergies to the placebo
Evaluation of a Primary Prevention Program for Anxiety Disorders Using Story Books

The purpose of this study is to assess the impact of a primary prevention program for anxiety disorders.

This study was completed between 2000 and 2002, with the final report transmitted to the Quebec ministry of health in 2003.

This study reports the results of a study evaluating a book-supported prevention program "Dominique's Handy Tricks" for anxiety disorders in children aged 9 to 12 years of age. This cognitive-behavioural program is delivered using a combination of story-based books and workshop sessions. The originality of the program comes from the use of story books that were not developed for anxiety management specifically. Every session is based on a story describing characters facing common stressors in childhood and how they managed to cope with their daily problems. In our randomized control trial with 46 children, participation in the program lead to a significant improvement in coping skills, self-efficacy, anxiety sensitivity, signs of anxiety and phobic avoidance. The theoretical and practical elements underlying the delivery of this primary prevention programs are described. It is suggested that such an approach, without any labelling specific to anxiety disorders, can be useful in universal primary prevention programs.

Eligibility Criteria:
Inclusion criteria:

* Recruitment for this study was open to every child in the school and was carried out with the help of staff from schools in Gatineau and Saint-André Avelin, Quebec.
* A total of 73 children aged between 9 and 12 years of age were screened.

Exclusion criteria:

Since the program does not target a clinical population, the following exclusion criteria were used:

* (1) a global score \> 75 on the Child Behavior Checklist;
* (2) a score \> 60 on the Screen for Child Anxiety Related Emotional Disorders (SCARED, child version);
* (3) outliers on outcome measures administered at pre-test; and
* (4) children who did not show up for the first workshop. The final enrolled study sample consisted of 59 children.
PET Imaging of Cancer Patients Using 124I-PUH71: A Pilot Study

The purpose of this study is to see how a new drug, named PUH71, accumulates in the different parts of the body \& inside tumors and how long PUH71 lasts in the blood, when given to study participants in tiny amounts. The results of this study will help researchers (1) plan how they will use PUH71 as an experimental new drug (at much-higher doses) for the treatment of cancer, in clinical trials; and (2) know whether PUH71 might be used as a drug for detecting tumors with scanner machines.


Eligibility Criteria:
Inclusion Criteria:

* Patients with solid malignancy, myeloproliferative neoplasm, myeloma, and/or lymphoma (histology confirmed by MSKCC Department of Pathology)
* Disease is measurable or evaluable as defined by RECIST (1.1 or original version) or other tumor response criteria from an MSKCC IRB-approved clinical research protocol.
* This does not apply to patients with myeloproliferative neoplasm. The presence of active myeloproliferative neoplasm will be determined by applicable disease specific diagnostic criteria and patient assessment by the patient's oncologist and trial investigators (eg, manifestations of active MPN such as splenomegaly, abnormal blood counts, etc).
* Age between 18-90
* Negative serum pregnancy test for females of childbearing age (11-55 years) and/or lack child-bearing potential
* No breast-feeding

Exclusion Criteria:

* Previous allergic reaction to contrast medium.
* Hypersensitivity to iodide products.
* Known hyperthyroidism

Hepatic:

* Bilirubin \> 1.5 x institutional upper limit of normal (ULN)
* AST/ALT \>2.5 x ULN
* Albumin \< 2 g/dl
* GGT \> 2.5 x ULN IF Alkaline phosphatase \> 2.5 x ULN. Renal: Creatinine \>1.5 x ULN or creatinine clearance \< 60 mL/min.
* Positive serum pregnancy test for females
* Acute major illness (e.g., infection, unstable cardiovascular condition, etc.)
Social Media Use During COVID-19

The investigators plan to conduct a cross-sectional survey to examine how social media use during COVID-19 relates to: (1) information management, (2) assessment of the situation, and (3) affect.


Eligibility Criteria:
Inclusion Criteria:

* At least 21 years
* Has stayed in Singapore for at least 2 years

Exclusion Criteria:

* Below 21 years
* Has stayed in Singapore for less than 2 years
Interscalene Brachial Plexus Block Combined With Suprascapular Nerve Block

The investigators compared the results of sono-guided interscalene brachial plexus block (ISB) combined with arthroscopy-guided suprascapular nerve block (SSNB) with those of ISB alone within the first 48 h after arthroscopic rotator cuff repair.

Forty-eight patients with rotator cuff tears who had undergone arthroscopic rotator cuff repair were enrolled. The 24 patients randomly allocated to group 1 received ISB and SSNB; the remaining 24 patients in group 2 underwent ISB alone. VAS pain score, patient's satisfaction (SAT) were checked postoperative 1, 3, 6, 12, 18, 24, 36, and 48 hours. VAS pain score was selected from 0 to 10 was no pain and 10 was severe pain that the patient had ever experienced. SAT was also selected from 0 to 10 was unsatisfactory and 10 was very satisfactory. Rebound of postoperative pain was confirmed if there had been an increase of VAS pain score after postoperative 1 hour.

Eligibility Criteria:
Inclusion Criteria:

1. definite rotator cuff tear on preoperative MRI, which needed repair;
2. acceptance of arthroscopic surgery including rotator cuff repair;
3. \> 20 years old; and
4. acceptance of routine regional blocks and patient-controlled analgesia.

Exclusion Criteria:

1. did not want arthroscopic rotator cuff repair;
2. stopped PCA before 48 h postoperatively due to side effects;
3. history of shoulder operation or fracture;
4. concomitant neurological disorder around the shoulder;
5. conversion to open surgery from the arthroscopy; and
6. contraindication to the routine regional blocks in this study
Ketamine for Postoperative Pain in Bariatric Surgery

The aim of this study was to evaluate an effect of pre - incisional single injection of low-dose ketamine on postoperative pain after remifentanil infusion in patients undergoing laparoscopic gastric bypass and gastric plication surgery. Ketamine is an old general anaesthetic. Low doses of it might be used as a adjunct in postoperative analgesia.The investigators expect that the low-dose ketamine reduces postoperative pain after bariatric surgeries.

Effective postoperative pain management enhances early postoperative rehabilitation and may improve outcomes of surgical treatment. New analgetic medications and combinations of these are sought for optimal analgesia with lowest possible incidence of side effects. One of the method of multimodal analgesia is a combination of opioids and adjuvant agents, such as ketamine. To our knowledge, the role of ketamine in the treatment of postoperative pain after bariatric surgeries is poorly researched. The investigators hypothesize that ketamine, acting through the N-methyl-D-aspartate receptor (NMDA) and opioid receptors, provides favourable conditions for adequate post-operative pain management.

Eligibility Criteria:
Inclusion Criteria:

* II or III The American Society of Anesthesiologists (ASA) physical status
* age \> 18 years
* bariatric surgery with general remifentanil anesthesia

Exclusion Criteria:

* anamnesis of using opioids for the treatment of chronic pain
* opioid dependence
* younger than 18 years
Periampullary Lesions Via ERCP in Assuit University Hospital

A periampullary lesion may be begin as duodenal adenoma, ampullary adenoma, gall stone pregnant ampulla, Stricture, or periampullary lipoma, or malignant as pancreatic ductal adenocarcinoma, distal CBD cholangiocarcinoma, ampullary carcinoma and periampullary duodenal adenocarcinoma, pancreatic carcinoma.

The aim of the study is to detect incidence of different types of periampullary lesions detected by ERCP in Assuit University Hospital and the role of ERCP in early detection, diagnosis and management and diagnostic accuracy and sensitivity of biopsy and brush cytology taken by ERCP in a period of 1 years starting from June 2017 to June 2018.

Periampullary lesion is defined as lesion located in 2CM around the ampulla of Vater. Periampullary lesions, identified during endoscopic retrograde cholangiopancreatography (ERCP), duodenoscopy or endoscopic ultrasonography (EUS) often present a diagnostic dilemma. Although some of these lesions represent a benign lesion, they also occur in case of malignancy. Therefore, management of periampullary lesions widely varies from observation for low-grade dysplasia to pancreaticoduodenectomy in case of invasive carcinoma. Unfortunately, endoscopic biopsies are by definition superficial and, therefore, the risk of a sample errors exists. On the other hand the similarity in presentation and the difficulty in accurate location of the origin of these lesions often leads to a diagnostic challenge. ERCP in addition to its diagnostic value it allows therapeutic procedures, such as sphincterotomy, stenting, and nasobiliary drainage. It permits sampling of pancreatic juice, bile, and brush or grasp biopsy, but endoscopic biopsies are by definition superficial and, therefore, the risk of a sample errors exists .

ERCP is an invasive procedure that requires an expert endoscopist/radiologist and a cooperative patient.

Very small tumors (\< 1 cm) can be missed. A periampullary lesion may be begin as duodenal adenoma, ampullary adenoma, gall stone pregnant ampulla, Stricture, or periampullary lipoma, or malignant as pancreatic ductal adenocarcinoma, distal CBD cholangiocarcinoma, ampullary carcinoma and periampullary duodenal adenocarcinoma, pancreatic carcinoma.

The aim of the study is to detect incidence of different types of periampullary lesions detected by ERCP in Assuit University Hospital and the role of ERCP in early detection, diagnosis and management and diagnostic accuracy and sensitivity of biopsy and brush cytology taken by ERCP in a period of 1 years starting from June 2017 to June 2018.

Eligibility Criteria:
Inclusion Criteria:

* All cases admitted in Assuit university hospital with periampullary lesions detected by ERCP within the period of the study.

Exclusion Criteria:

* Cases diagnosed to have periampullary lesion and managed without ERCP
Capecitabine as Radiosensitising Agent in Neoadjuvant Treatment of Locally Advanced Resectable Rectal Cancer

A Phase II study aimed to evaluate the efficacy and toxicity of preoperative chemoradiotherapy with capecitabine in locally advanced resectable rectal cancer.

Preoperative chemoradiation has become a standard part of treatment protocols in stage II and III rectal cancer. Compared to postoperative chemoradiotherapy, the advantage of preoperative application of chemotherapeutics and irradiation includes improved compliance, reduced toxicity and downstaging of the tumour in a substantial number of patients. The latter may enhance the rate of curative surgery, permit sphincter preservation in patients with low-sited tumours and have a positive impact on the quality of life of these patients. Orally administered capecitabine (Xeloda®, Hoffmann - La Roche Ltd, Basel, Switzerland) mimics the pharmacokinetics of continuous 5-FU infusion and makes chemoradiotherapy more patient-friendly. The mechanism of capecitabine activation, preferably in tumour cells, may further enhance its efficacy and tolerability, offering the potential for an enhanced therapeutic ratio.The aim of the present phase II study was to evaluate the efficacy and toxicity of preoperative chemoradiotherapy with capecitabine in patients with locally advanced rectal cancer. The primary endpoint of the study is a pathologically determined complete remission rate (pCR) of the disease locally and regionally. Secondly, the rate of sphincter preservation in low-sited tumours, overall downstaging rate,toxicity and survival parameters will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* histologically verified adenocarcinoma of the rectum,
* resectable clinical stage II or III (IUCC TNM classification 2002);
* no prior radiotherapy and/or chemotherapy;
* World Health Organisation (WHO) performance status \< 2;
* age at diagnosis of 18 or older;
* and adequate bone marrow, liver, renal and cardiac function (no history of ischemic heart disease).

Exclusion Criteria:

* A history of prior malignancy other than non-melanoma skin cancer or in situ carcinoma of the cervix
An Extension Study of Duloxetine in Fibromyalgia (Extension of F1J-JE-HMGZ, NCT01552057)

The purpose of the study is to assess the safety and efficacy of duloxetine in participants with fibromyalgia at long-term use.


Eligibility Criteria:
Inclusion Criteria:

* Participants who have completed the 15-week treatment in the preceding study HMGZ
* Participants who wish continuous treatment with duloxetine after the preceding study
* Participants are able to give their own written consent

Exclusion Criteria:

* Participants with serious cardiovascular, hepatic, renal, respiratory, or hematological disease, or clinically significant laboratory or electrocardiogram abnormality which indicate a serious medical problem or require significant intervention in the judgment of the investigators
* Participants with alanine aminotransferase/aspartate aminotransferase of not less than 100 International Units/Liter (IU/L) or total bilirubin of not less than 1.6 milligrams/deciliter (mg/dL) at Week 0 (Visit 8 of the preceding study)
* Participants with serum creatinine level of not less than 2.0 mg/dL, participant who has undergone kidney transplantation or hemodialysis at Week 0 (Visit 8 of the preceding study)
* Participants with pain difficult to discriminate from pain associated with fibromyalgia or disease which disturbs the assessment
* Participants with thyroidal dysfunction, excluding those assessed by the investigator that the disorder is controlled as appropriate by three-month or longer drug therapy
* Participants with present or past history of rheumatoid arthritis, inflammatory arthritis, infectious arthritis, or auto immune disease rather than thyroid deficiency
* Participants with uncontrolled angle closure glaucoma
* Participants who received monoamine oxidase (MAO) inhibitors within 14 days before Week 0 (Visit 8 of the preceding study) or need to receive a MAO inhibitor within 5 days after study discontinuation
* Participants who have experienced suicidal ideation or suicide attempt during the preceding study
* Participants answering "yes" to any of the questions about active suicidal ideation/intent/behaviors occurring in the preceding study (Columbia Suicide Severity Rating Scale, Suicide Ideation section - Questions 4 and 5; Suicidal Behavior section)
* Female participants who are pregnant, lactating, or who want to get pregnant during the study period. Male participants who want his partner to get pregnant
* Females of child-bearing potential who cannot agree to utilize medically acceptable and reliable means of birth control during the study and for 1 month following the last dose of the study
* Participants assessed ineligible by the investigator (sub-investigator) for other reasons
Efficacy of Magnesium Sulfate Bolus in Pediatric Patients With Bronchiolitis

The purpose of this study is to more rigorously evaluate the response to a single bolus of magnesium sulfate in a population of patients with moderate to severe bronchiolitis. The primary outcome will be to evaluate the effect of this therapy on clinical respiratory status. Secondary outcomes of interest will include the incidence of adverse effects and safety profile of magnesium bolus use in this population.

This randomized placebo-controlled pilot study is designed to evaluate the above referenced outcomes. Study drug initiation will occur in the local pediatric intensive care unit in patients with a clinical diagnosis of bronchiolitis and whose parent/LAR consents for their participation. Our goal is to enroll and evaluate a total of 40 patients.

Upon obtaining informed consent, the participant will receive an enrollment history and physical to include: baseline Modified Pulmonary Index Score (MPIS), blood pressure, vital signs, and epidemiologic data. The participant will then receive either a bolus of 50mg/kg Magnesium Sulfate (MgSO4) or normal saline as placebo medication over twenty minutes. Vital signs and MPIS will be monitored according to the study schedule, for a total of six hours. During the period of monitoring subjects will not receive additional bronchodilators unless otherwise deemed clinically necessary by the subject's attending physician. If administered, these will be recorded by investigative team.

Eligibility Criteria:
Inclusion Criteria:

* Infants under 12 months of age
* Admitted to the pediatric intensive care unit
* Moderate/severe bronchiolitis using MPIS
* Less than 24 hours of admission to the PICU
* Parent/LAR consents for infant to participate

Exclusion Criteria:

* Patients with the following conditions are ineligible: chronic lung disease, unrepaired congenital heart disease, and cyanotic heart disease.