cyrilzakka/clinical-trials huggingface dataset:
Three-pronged Centralized Molecular Analysis to Optimize Detection of NTRK1,2,3 Fusions in Thyroid Cancer

This multi-center study aims at NTRK fusion testing of all patients with advanced thyroid cancer (any histotype and regardless of stage). The primary objective of this study is to assess the frequency of NTRK fusions in thyroid cancer. The secondary objective of this study is to develop an effective tool (testing) strategy for the detection of NTRK fusions in thyroid tumors, comparing the diagnostic tecniques available (IHC, real-time PCR and NGS).

Thyroid cancer is the most common neoplasm of the endocrine system. Most thyroid carcinomas originate from the follicular epithelium and are distinguished in differentiated forms (DTC): papillary (PTC) and follicular (FTC) carcinomas. Both have a favorable prognosis and account for approximately 80% and 10% of all thyroid neoplasms, respectively. The undifferentiated form represented by the anaplastic thyroid carcinoma (ATC) is less frequent (about 2%) and represents one of the most aggressive human tumors with a survival that rarely exceeds 6-12 months. Medullary thyroid carcinoma (MTC), deriving from parafollicular C cells, is relatively rare (approximately 5%) and is associated with an intermediate prognosis between differentiated and poorly differentiated forms.

As to the prevalence of NTRK lesions, many authoritative papers and reviews claim very high (up to 75%) NTRK fusion frequencies, particularly in the common PTC. However, an extensive PubMed analysis back to year 1990 does not provide convincing support for this claim.Several techniques for NTRK fusion diagnosis exist, including pan-Trk IHC, FISH, reverse transcription PCR, DNA-based next-generation sequencing (NGS), and RNA-based NGS. Each of these assays has unique features, advantages, and limitations, and familiarity with these assays is critical to appropriately screen for NTRK fusions.

The aim of this study is to determine the frequency of NTRK fusions in advanced thyroid cancer patients and to compare the diagnostic tecniques available (IHC, real-time PCR and NGS).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced thyroid cancer (any histotype)
* Informed consent.

Exclusion Criteria:

* Patients with thyroid neoplasms without appropriate material for subsequent immunohistochemical and molecular studies;
* Patients with non-advanced thyroid cancer
Pharmacokinetics (PK) and Safety Evaluation of Daptomycin in Children Ages 3-24 Months With Proven or Suspected Gram-positive Infections or Peri-Operative Subjects Receiving Prophylactic Antibiotics

This is a research study designed to look at the pharmacokinetics (distribution, breakdown, and removal) and tolerability of a single dose of daptomycin in patients aged 3 months to 24 months who have proven or suspected infections that are caused by a specific group of bacteria (called Gram-positive bacteria)or perioperative subjects that are receiving prophylactic antibiotics .


Eligibility Criteria:
Inclusion Criteria:

1. Written parental (or appropriate legal representative) informed consent prior to any study-related procedure not part of normal medical care; 2.1 Male or female between the ages of 3 months and 24 months, inclusive; 3. Able to comply with the protocol for the duration of the study; 4.1 Clinically stable with no evidence of hemodynamic instability (defined as a requirement for inotropic or vasodilatory support to manage blood pressure) in the 24 hour window prior to first dose, and no history or evidence of renal or hepatic compromise; 5.1 Suspected or diagnosed bacterial infection for which the subject is receiving standard antibiotic therapy; including prophylactic use of antibiotics peri-operatively; 6. A calculated creatinine clearance rate (CLcr) ≥ 80 ml/min/1.73m2 as determined by the Schwartz equation at baseline; 7. Creatine phosphokinase (CPK) levels less than 2X ULN (upper limit of normal) at baseline; 8.1 Presence of two patent intravenous lines (or comparable means of venous or arterial access)prior to dosing on Study Day 1. A single intravenous line (or comparable means of venous access) is acceptable for both drug administration and sample collection if reasonable effort to gain a second line is unsuccessful. The line must be flushed as described in Appendix B of the protocol prior to obtaining PK samples. PK sample can be obtained from a peri-operatively placed arterial line. Arterial PK samples should be indicated on the CRF.

Exclusion Criteria:

1. Investigational drug use (including daptomycin) or participation in any experimental procedure in the 30 days preceding study entry;
2. Known allergy/ hypersensitivity to daptomycin; 3.1 History of clinically significant, renal, hepatic, autoimmune disease or primary immune deficiency;

4. Deleted 5. Subjects with clinically significant abnormal laboratory test results (including ECGs), as determined by Investigator; 6. Administration of rifampin within 7 days of study drug administration; 7. Deleted 8. Subjects in whom collection of the required blood volume would put them at risk of hemodynamic disturbance (at the discretion of Investigator); 9. Deleted; 10.1 Planned administration of intramuscular injection within 12 hours following study administration unless approved by the Medical Monitor; 11. Deleted 12.1 Guillian-Barre or spinal cord injury; 13. History of or current rhabdomyolysis.
Efficacy of Inspiratory Muscle Training on Respiratory Performance in Patients With Esophageal Cancer Receiving Combined Modality Therapy

The purpose of this study is to investigate the effectiveness of inspiratory muscle training (IMT) on respiratory performance in patients with esophageal cancer during combined modality therapy.

Background and Purpose: Incidence rates of esophageal cancer remain high in Eastern Asia. In 2012, esophageal cancer was the 9th leading cause of cancer deaths in Taiwan. Whether surgical resection is possible, combined modality therapy is usually required for the treatment of esophageal cancer. In clinical observation, patients underwent combined modality therapy usually demonstrated respiratory muscle dysfunction which might further impair physical activity and quality of life. The purpose of this study is to investigate the effectiveness of inspiratory muscle training (IMT) on respiratory performance in patients with esophageal cancer during combined modality therapy.

Methods: This is a prospective interventional study design. A total of 45 patients with newly diagnosed esophageal cancer will be recruited from the Mackay Memorial Hospital. All tests will be performed at baseline (prior to cancer treatment), weekly during treatment, prior to surgery, and one month after surgery. Tests will include demographic data collection, respiratory muscle performance (maximal inspiratory and expiratory pressure tests combined with diaphragmatic surface electromyography, and pulmonary functional test), dyspnea, and the functional exercise test (6-min walk test). IMT will start with an intensity of 30% of maximal inspiratory pressure, 15 times/set, 3 sets/day, 7 days/week and training will continue until surgery is scheduled or 2 weeks after the completion of treatment if surgery is not suitable. Repeated measure ANOVA will be used for analyzing difference of parameters among various time points.

Clinical relevance: The results of this study will help to better understand the clinical beneficial effects (e.g., better functional capacity) of an added inspiratory muscle training during combined modality therapy in patients with esophageal cancer.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed primary esophageal cancer, aged more than 20 years, communicate without difficulty.

Exclusion Criteria:

* inability to perform inspiratory muscle training, the presence of unstable angina or myocardial infarction in recently one month, cannot cooperate with training protocols, and pregnancy.
Stress Biomarkers Among Patients Undergoing Treatment for Excited Delirium and Severe Pain in the Emergency Department

The purpose of this project is to determine the levels of stress biomarkers associated with severe pain, agitation from intoxication or psychosis, and excited delirium at various levels of the disease in order to compare them to pre-clinical models of law enforcement encounters. We hypothesize that the serum catecholamines and markers of metabolic acidosis will worsen with the duration and severity of agitation among agitated patients and will not worsen among patients with severe pain who are not agitated.

Specific Aims

* To assess the prevalence of patients undergoing treatment for agitation from any cause requiring restraint or sedation.
* To assess the prevalence of excited delirium in the emergency department.
* To determine the difference in serum total catecholamines, serum dopamine, serum epinephrine, serum norepinephrine, heart rate, systolic blood pressure, mean arterial pressure, mortality, and disposition among patients with agitation requiring restraint, including excited delirium and patients with severe pain from extremity fractures.
* To describe changes in stress biomarkers among patients with changing levels of agitation as determined by the Altered Mental Status scale.

In this study, we propose to study Emergency Department patients under physiologic stress from severe pain, agitation, drug overdose, and excited delirium in order to compare markers of acidosis in patients at risk for unexplained-in-custody-death (UICD) in order to determine the relationship of these markers to what has been found in simulated law enforcement encounters. This information will help clarify the levels of stress associated with arrest and restraint conditions, allowing us to determine what aspects and levels of stress may be associated with the fatal mechanisms of UICD, and to identify markers that would inform death investigators of the mechanism of UICD. At the conclusion of this project, we will be able to report details explaining the relationship of the physiologic and metabolic effects of stress from restraint in excited delirium to other peri-arrest conditions and our previous work in simulated law enforcement encounters.

Eligibility Criteria:
Agitation Group Inclusion Criteria:

* Patients with agitation as defined by an Altered Mental Status Score of \>1, and who are in restraints or are given sedatives for treatment of agitation.

Agitation Group Exclusion Criteria:

* Less than 18 years of age
* Suspected or confirmed pregnancy

Pain Group Inclusion Criteria:

* Patients with an extremity fracture who report their pain as severe.

Pain Group Exclusion Criteria:

* Less than 18 years of age
* Suspected or confirmed pregnancy
* Prisoner
A Study of OV101 in Individuals With Angelman Syndrome (AS)

The purpose of this study is to assess the efficacy and safety of oral OV101 (gaboxadol) in pediatric subjects with Angelman syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Male or female and 2 to 12 years old (inclusive) at the time of informed consent
* Confirmed molecular diagnosis of AS
* Has a CGI-S-AS score of 3 or more at baseline.
* Meets the following age-appropriate body weight criterion:

  1. Subjects 2 to 3 years old must have a minimum body weight of 9 kg.
  2. Subjects 4 years and older must be between 17 kg and 64 kg (inclusive).
* Stable concomitant mediations for at least 4 weeks before study start

Exclusion Criteria:

* Any condition that would limit study participation
* Clinically significant lab or vital sign abnormalities at the time of screening
* Poorly controlled seizures (weekly seizures of any frequency with a duration more than 3 minutes, weekly seizures occurring more than 3 times per week, each with a duration of less than 3 minutes, or as defined by investigator assessment)
* Use of prescription medications for sleep, minocycline, or levodopa within the 4 weeks prior to Day 1 or during the study. Benzodiazepines chronically administered for seizure control are permitted.
* Cannot comply with protocol study assessments during screening or caregiver unable to comply with study requirements.
* Enrolled in any clinical trial or used any investigational agent within the 30 days before screening or concurrently with this study.
A Study of Onartuzumab (MetMAb) Versus Placebo in Combination With Paclitaxel Plus Platinum in Patients With Squamous Non-Small Cell Lung Cancer

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in patients with incurable Stage IIIB or Stage IV squamous non-small cell lung cancer (NSCLC). Patients will be randomized to receive either onartuzumab (MetMAb) 15 mg/kg iv or placebo on Day 1 of each 21-day cycle in combination with 4 cycles of paclitaxel 200 mg/m2 iv and platinum (carboplatin/cisplatin) iv on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will continue with either onartuzumab (MetMAb) or placebo as maintenance therapy until disease progression or unacceptable toxicity occurs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Histologically or cytologically confirmed Stage III B or Stage IV squamous non-small cell lung cancer (NSCLC)
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* No prior chemotherapy for squamous NSCLC
* Adequate tissue for central IHC assay of Met receptor, and EGFR testing if EGFR status is unknown
* Radiographic evidence of disease

Exclusion Criteria:

* Prior systemic treatment for Stage IIIB or IV squamous NSCLC
* NSCLC with histology classified as adenocarcinoma, large cell, mixed adenosquamous, or NSCLC not otherwise specified (NOS)
* Prior exposure to experimental treatment targeting either the HGF or Met pathway
* Patients with tumors confirmed to have EGFR-activating mutations who are suitable for anti-EGFR therapy (e.g. gefitinib or erlotinib), as determined by the investigator
* Uncontrolled brain metastases and treatment by neurosurgical resection or brain biopsy within 4 weeks prior to Day 1 of Cycle 1
* History of another malignancy in the previous 3 years except for prior history of in situ cancer or basal or squamous cell skin cancer
* Pregnant or lactating women
* Uncontrolled diabetes
* Impaired bone marrow, liver or renal function as defined by protocol
* Significant history of cardiovascular disease
* Positive for HIV infection
Clinical Relevance of the Salvage Treatment for Colorectal Neuroendocrine Tumors

we evaluated all related clinical and pathologic data of rectal NET cases, including the resection margin status, NET grading, and lymphovascular invasion status. Finally, the present study was aimed at (1) determining the risk factors for LN and distant metastases in colorectal NETs (2) clarifying the clinical significance of the salvage treatment for colorectal neuroendocrine tumors following initial endoscopic resection with positive resection margin status and (3) compare different salvage treatment of this uncommon disease through conducting a large, multi-center cohort study.


Eligibility Criteria:
Inclusion Criteria:

* within the age range of 18 to 65 years, diagnosed with rectal neuroendocrine tumors. Furthermore, patients were required to have a palpable tumor as determined by digital rectal examination or accessible through proctoscopy, with the distal border situated within 12 cm from the anal verge.

Exclusion Criteria:

* (1) muscularis propria invasion or NET grading = 3, (2)regional LN or distant organs metastasis at the time of diagnosis, (3) incomplete follow-up information, (4) the patient had multiple primary tumors, (5) patients with surgical excision or inappropriate methods such as forceps removal, and (6) the patient had a history of malignant tumors.
Correlation Between Dehydroepiandrosterone Sulfate and Sebum Level in Adult Female Acne Vulgaris

The aim of this study is to determine the correlation between Dehydroepiandrosterone sulfate (DHEAS) and sebum level in adult female acne. A cross sectional study was conducted with 50 samples, in June to October 2017.

Epidemiological studies have shown that number of adult female acne vulgaris (AV) increases. Hormone, sebum production, Propionibacterium acne and inflammatory process are factors involved in AV development. The aim of this study is to determine the correlation between Dehydroepiandrosterone sulfate (DHEAS) and sebum level in adult female acne. This research used cross sectional study with 50 samples, aged 25-49 years by consecutive sampling. The degree of acne vulgaris was evaluated using Lehman criteria , and then the sebum level and DHEAS were measured objectively using sebumeter and serum, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Female, age 25-29 years
* Diagnosed with mild to severe acne vulgaris
* Agree to participate

Exclusion Criteria:

* History of taking antiandrogen drugs
* History of taking oral and topical antibiotics, using topical retinoid and BPO in the last 4 weeks
* History of taking oral isotretinoin in the last 6 months
* Pregnancy or breastfeeding
ENDO-AID Assisted Tandem Colonoscopy RCT

This study hypothesizes that more adenomas will be detected using the ENDO-AID assisted Colonoscopy compared to conventional colonoscopy.

A single-centre, randomized, same-day, back-to-back tandem colonoscopy trial comparing Adenoma Missed Rate and Adenoma Detection Rate in ENDO-AID assisted colonoscopy and conventional colonoscopy.

Colorectal cancer is the third common cancer in the world and the commonest cancer in Hong Kong. Most sporadic colorectal cancers arise from benign polyps via adenoma-carcinoma sequence or the serrated polyp-carcinoma sequence. There are reports of unexpectedly high risk of interval carcinomas, as high as up to 9%, raising concerns about the effectiveness of colonoscopy in preventing colorectal cancers. Different techniques have been described to improve the area of mucosa visualised but lesions may still be missed due to failure of identification by the endoscopist.

Computer Aided diagnosis (CAD) assisted colonoscopy is becoming increasingly popular to address human error. Deep learning technology has surpassed human learning and advancement in technology now allows real-time Artificial Intelligence to assist colonoscopists in polyp detection.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18years or above
* Referred to endoscopy unit for diagnostic or surveillance colonoscopy

Exclusion Criteria:

* Familial history of Familial adenomatous polyposis / Hereditary non-polyposis colorectal cancer
* Known history of inflammatory bowel disease
* Known colitis or suspicion of colitis (inflammatory bowel disease, diverticulitis, infective colitis)
* Emergency endoscopy of any nature (eg gastrointestinal bleeding, colonic decompression)
* Previous incomplete colonoscopy (not including insufficient preparation) / difficult colonoscopy
* Patients referred for a therapeutic procedure or assessment of a known non-resected lesion
* Patients with known palliative colorectal malignancy
* Patient with coagulopathy
* Patient with colostomy
* Patient with multiple co-morbidities (American Society of Anaesthesiologist \>3)
* Inability to give informed consent
START - Early Thrombocyte Administration to Patients With Ruptured Abdominal Aortic Aneurism

The purpose of this study is to investigate the effect of platelet infusion prior to transfer to a vascular surgical department in patients with a ruptured abdominal aortic aneurism.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with rAAA either by clinical evaluation or CT or UL

Exclusion Criteria:

* formerly randomized in the study
* aneurism not ruptured during operation
Transfer of Feces in Ulcerative Colitis 2

The goal of this placebo-controlled randomised multicenter trial is to evaluate the efficacy and safety of anaerobic prepared donor fecal microbiota transplantation (FMT) compared to autologous FMT in patient with ulcerative colitis.

Participants will receive 4 treatments with frozen FMT via both upper and lower gastro-intestinal route (infusion via duodenal tube and enemas).

Donors are selected based on microbiota profile.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and \<70
* Ability to give informed consent
* Established ulcerative colitis with known involvement of the left colon according to the Lennard-Jones criteria
* Partial mayo score of ≥ 3 and calprotectin \> 250
* Full Mayo score 5-9
* Endoscopic Mayo score of ≥2 in either the rectum or sigmoid upon screening sigmoidoscopy
* Stable dose of thiopurines or , 5-ASA, or budesonide in preceding 8 weeks.
* Stable dose of budesonide in preceding 2 weeks.
* Prednisone use ≤15mg/day in preceding 2 weeks with a mandatory taper of 5 mg per week starting from week 4.
* Women need to use reliable contraceptives during participation in the study
* Alkaline phosphatase \> 1.5 x ULN in the subgroup of PSC/UC patients.

Exclusion Criteria:

* Condition leading to profound immunosuppression

  * For example: HIV, infectious diseases leading to immunosuppression, bone marrow malignancies
  * Use of systemic chemotherapy
  * Child-Pugh B liver cirrhosis
* Anti-TNFα treatment in preceding 2 months
* Vedolizumab treatment in preceding 2 months
* Tofacitinib treatment in preceding 2 months
* Ustekinumab treatment in preceding 2 months
* Cyclosporine treatment in preceding 4 weeks
* Use of Methotrexate in preceding 2 months
* Prednisolone dose \> 15 mg/day in preceding 2 weeks
* Use of topical therapy in preceding 2 weeks
* Life expectancy \< 12 months
* Difficulty with swallowing
* Use of systemic antibiotics in preceding 4 weeks
* Use of probiotic treatment in preceding 4 weeks
* Positive stool cultures for common enteric pathogens (Salmonella, Shigella, Yersinia, Campylobacter, enteropathogenic e coli)
* Positive C. Difficile stool test
* Positive dual faeces test for pathogenic parasites e.g. Dientamoeba histolytica, Giardia Lamblia, Dientamoeba fragilis, Blastocystis hominis only if microscopically many or very many blastocysts are seen.
* Positive serological test for HIV
* History of surgery:

  * presence of a pouch
  * presence of stoma
* Known intra-abdominal fistula
* Pregnancy or women who give breastfeeding
* Vasopressive medication, icu stay
* Signs of ileus, diminished passage
* Allergy to macrogol or substituents, eg peanuts, shellfish
* Known allergy to iv gadolinium in the subgroup of patients who would be scheduled for MRI liver
* Crohn's disease
* Subject who has any conditions that in the opinion of the investigator, would compromise the safety of the subject or the quality of the data and is an unsuitable candidate for the study