cyrilzakka/clinical-trials huggingface dataset:
CAN008 Biomarker CD95 Ligand and CpG2 Methylation in Chinese Patients With Glioblastoma

This study was conducted on the post-operative tumor tissues from 62 GBM patients. 20 slices are necessary for all the CD95 and CpG2 test in the central lab by the methods of immunisation and DNA methylation.


Eligibility Criteria:
Inclusion Criteria:

* Chinese nationality
* No limits on Gender and age
* First diagnosed GBM
* Brain tumor tissue cytological diagnosis of glioblastoma (GBM, pleomorphic glioblastoma, WHO level IV)

Exclusion Criteria:

* Other types of glioma by histological diagnosis
* Tumor tissue not eligible for the central laboratory testing standard
* No enough tumor tissue for the central laboratory test
Efficacy of Dextenza Insert in Upper vs Lower Punctum Following Cataract Surgery With PCIOL.

To assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.

This is a randomized, controlled study to evaluate the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.

Eligibility Criteria:
Inclusion Criteria:

Subjects will be eligible for study participation if they:

1. Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes with or without iStent/Hydrus/Goniotomy.
2. Are willing and able to comply with clinic visits and study related procedures.
3. Are willing and able to sign the informed consent form.
4. Not pregnant.

Exclusion Criteria:

Subjects are not eligible for study participation if they:

1. Are currently being treated with corticosteroid implant (i.e. Ozurdex).
2. Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye.
3. Have a history of complete punctal occlusion in one or both punctum.
4. Currently use topical ophthalmic steroid medications.
5. Are unwilling or unable to comply with the study protocol.
6. Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular disease/abnormality) or if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment.
7. Have active infectious systemic disease.
8. Have active infectious ocular or extraocular disease.
9. Have unobstructed nasolacrimal duct in the study eye(s) (dacrocystitis).
10. Have known hypersensitivity to dexamethasone or are a known steroid responder.
11. Have a history of ocular inflammation or macular edema.
12. Are currently being treated with immunomodulating agents in the study eye(s).
13. Are currently being treated with immunosuppressants an/or oral steroids.
14. Are Pregnant or breast-feeding or wish to become pregnant during the length of study participation.
Diagnostic Evaluation of Patients With Neuromuscular Disease

The objectives of this protocol are to: 1) screen patients with various neuromuscular disorders and facilitate their entry into appropriate research protocols; 2) help resolve puzzling diagnostic neuromuscular problems and train fellows in the evaluation and treatment of Neuromuscular Diseases; and 3) provide follow up to patients who finished their participation in a previous study but they are not currently entered in another research protocol. No investigational treatments will be performed on this protocol but the tissues collected can be used for future research studies.

The objectives of this protocol are to: 1) screen patients with various neuromuscular disorders and facilitate their entry into appropriate research protocols; 2) help resolve puzzling diagnostic neuromuscular problems and train fellows in the evaluation and treatment of Neuromuscular Diseases; and 3) provide follow up to patients who finished their participation in a previous study but they are not currently entered in another research protocol. No investigational treatments will be performed on this protocol but the tissues collected can be used for future research studies.

Eligibility Criteria:
* INCLUSION CRITERIA:

Research patients will be studied under this protocol if they fulfill the following criteria:

Have an identifiable neuromuscular disorder that may be suitable for a specific current or future protocol;

Present a diagnostic puzzle in spite of the previously performed diagnostic work-up;

Have unusual manifestation of a more usual neuromuscular disease;

Have a disorder useful for teaching purposes.

Patients should be referred by a physician who will continue their care after our evaluation. A report of the patients' visit and tests, along with suggestions or recommendations will be sent to each referring physician. There is a wide spectrum of neuromuscular diseases to be studied, among them are: peripheral neuropathies, myopathies, dystrophies, myasthenia, stiff person syndrome, muscle cramps, myotonias, motor neuron diseases, post-polio syndrome, and certain demyelinating disorders affecting both the central and the peripheral nervous system.
COgnitive and Physical Exercise (COPE) Prehabilitation Pilot Feasibility Study

Cognitive and functional impairment are debilitating problems for survivors of major surgery. Efforts to modify medical treatments to prevent such impairment are ongoing and may yet yield significant benefits. An area in need of study is whether building patients' cognitive and physical reserve through a prescribed program of cognitive and physical exercise before the physiological insult (a prehabilitation effort) can improve long-term outcomes. Prehabilitation efforts before surgery thus far have focused on preemptive physical therapy to improve post-surgical functional outcomes. No work, however, has been done to attenuate the cognitive decline commonly seen after surgical illness by exercising the brain before the surgical insult. Cognitive prehabilitation is a novel therapeutic approach that applies well-understood techniques derived from brain plasticity research. Our approach is bolstered by data that demonstrate that cognitive training programs are effective and have a very high likelihood of fostering improvement in patient outcomes across a range of populations. It is not yet known if these programs can improve cognitive reserve, allowing patients' minds to better manage the acute stress of surgery and hospitalization. The primary aim of this pilot study is to evaluate the feasibility of cognitive and physical prehabilitation training in adult patients undergoing major non-cardiac surgery who are at risk for postoperative cognitive and functional decline. The secondary aim is to study the effects of cognitive and physical prehabilitation training on cognitive abilities, functional status, and quality of life after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Adults undergoing major surgery with the likelihood of prolonged hospitalization or critical illness among the following surgical services: general surgery, surgical oncology, otolaryngology, hepatobiliary, thoracic, and vascular surgery

Exclusion Criteria:

* Blind, deaf, or unable to speak English, as these conditions would preclude our ability to perform the proposed cognitive and physical program
* Pregnancy
* Prisoners
* Severe frailty or physical impairment that prohibits participation in prehabilitation program
* Patients with documented dementia or cognitive impairment that precludes ability to self-consent for surgery and study participation
* Less than 2 weeks from scheduled surgery
* Patients without home internet access
Prognostic Value of Androgen Receptor Expression and Mutations Within Oncogenes and Tumor Suppressor Genes in Patients Treated for High Risk Prostate Cancer With Proton Therapy (PRX32)

Retrospective Review Study for Prognostic Transcriptional Output Related to Androgen Receptor Expression in Patients Treated for High Risk Prostate Cancer with Proton Therapy


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (older than 18 years at time of treatment) with high risk prostate cancer who were treated with proton therapy at UFHPTI/Department of Radiation Oncology
* Patients treated between 6/10/2010 through 4/26/17 with at least 2 years follow up
Efficacy of TAK-438 Compared to Placebo in the Treatment of Non-Erosive Gastroesophageal Reflux Disease

The purpose of this study is to investigate the superiority of efficacy of TAK-438, once daily (QD), to placebo in patients with non-erosive gastroesophageal reflux disease.


Eligibility Criteria:
Inclusion Criteria:

1. Participants with grade N or M in the modified LA classification system confirmed by endoscopy at initiation of the pre-observation period (VISIT 1).
2. Participants with repeated acid reflux symptoms (heartburn or regurgitation) for 2 days or more in one week in the 3 weeks before initiation of initiation of the pre-observation period (VISIT 1).
3. Participants with severity\* of moderate or higher for acid reflux symptoms (heartburn or regurgitation) in the 3 weeks before initiation of the pre-observation period (VISIT 1)

   \* Severity: No symptoms, very mild (symptoms present but often forgotten), mild (not so painful), moderate (rather painful), severe (painful) and very severe (painful enough to affect night time sleep or daily activities)
4. Outpatients (hospitalization for testing possible)

Exclusion Criteria:

1. Participants with an esophagus-related complication \[Barrett's esophagus (3 cm or more, LSBE), eosinophilic esophagitis, esophageal varices, scleroderma, viral or fungal infections, esophageal stenosis, etc.\], or a history of radiotherapy or cryotherapy of the esophagus, a caustic or physiochemical trauma (esophageal sclerotherapy, etc.). However, participants with Barrett's esophagus (less than 3 cm, SSBE) or Schatzki's ring (mucosal tissue ring around inferior esophageal sphincter) are allowed to be included.
2. Participants who have received surgery or treatment affecting gastroesophageal reflux (cardioplasty, dilation of esophageal stenosis \[excluding Schatzki's ring\], etc.), or who have a history of surgery of stomach or duodenum (excluding removal of benign polyp under endoscopy)
3. Participants who have acute upper gastrointestinal bleeding, gastric ulcers (mucosal defects associated with white coating) or duodenal ulcers (mucosal defect with white coating) within 30 days before initiation of the pre-observation period (VISIT 1) However, participants with gastric or duodenal erosions are allowed to be included.
4. Participants with acute gastritis or acute exacerbation of chronic gastritis as a complication
5. Participants with a previous or current history of the Zollinger-Ellison syndrome or other gastric acid hypersecretion disorders
6. Participants with a history of chest pain due to heart disease or with chest pains suspected of being caused by heart disease within one year before initiation of the pre-observation period (VISIT 1)
Immune Reconstitution to CMV After HSCT: Impact of Clinical Factors and Therapy Strategies

Cytomegalovirus (CMV) remains a significant cause of morbidity and mortality after hematopoietic stem cell transplantation (HSCT). The course and outcome of CMV infection are different clinically, and the mechanism of CMV infection after transplantation has not been clarified. Reconstitution of cellular immunity after HSCT is a critical determinant of the control of CMV infection.

Investigators will dynamically monitor the CMV-specific cellular immune reconstitution after HSCT，and analyze the clinical factors and therapy strategies affecting recovery of CMV-specific immunity during 1 year after HSCT.

Cytomegalovirus (CMV) remains a significant cause of morbidity and mortality after hematopoietic stem cell transplantation (HSCT). The course and outcome of CMV infection are different clinically, and the mechanism of CMV infection after transplantation has not been clarified. Reconstitution of cellular immunity after HSCT is a critical determinant of the control of CMV infection.

Investigators will collect peripheral blood at 1 month, 2 month, 3 month, and 6 month after HSCT from the participated patients, and dynamically monitor the CMV-specific T and NK cellular immune reconstitution.

Investigators will also analyze the clinical factors and therapy strategies affecting recovery of CMV-specific immunity during 1 year after HSCT.

Eligibility Criteria:
Inclusion Criteria:

* Be receiving a first allogeneic HSCT.
* Is male or female, from 14 years to any years of age inclusive.
* The participant (or legally acceptable representative) agree for cellular immune investigation and has provided documented informed consent/assent for the study.

Exclusion Criteria:

* Received a previous allogeneic HSCT (Note: Receipt of a previous autologous HSCT is acceptable).
* Has a history of CMV end-organ disease within 6 months prior to allocation.
* Has severe organ (hepatic , renal, cardical) insufficiency within 5 days prior to allocation.
* Any rapidly-progressing disease or immediately life-threatening illness.
Sleep Architecture and Factors Associated With Definitive Diagnosis of Sleep Bruxism

This case-control study will evaluates the association between the definitive sleep bruxism diagnosis by gold-standard polysomnography examination obtained at Pelotas Sleep Institute and the sociodemographic, occupational, clinical conditions, sleep quality, sleep structure and Epworth sleepiness scale variables.

Currently, as sleep and awake bruxism are generally considered as different behaviours observed during sleep and wakefulness, respectively, the single definition for bruxism is recommended be "retired" in favour of 2 separate definitions. In this sense, the sleep bruxism is a masticatory muscle activity during sleep that is characterised as rhythmic (phasic) or non-rhythmic (tonic) and is not a movement disorder or a sleep disorder in otherwise healthy individuals .The diagnosis of sleep bruxism often is challenging and despite the use of questionnaires, clinical exams and portable devices, based on current knowledge, the polysomnography with audio-video recordings emerges as the gold-standard criteria for a definite sleep bruxism diagnosis.

Included on the questionnaire there is a registration form, which contains: Sociodemographic: self-reported ethnicity, marital status, education level; Occupational: individuals were asked about work outside home, working hours; Clinical condition: body mass index, smoking; alcohol consumption; use of sleeping pills.

Sleep Quality, was evaluated with the following questions: Sleep behavioral, how long does it take to sleep; restless sleep; nightmares; heartburn, obstructive sleep apnea by polysomnography. Bedtime, sleep time. Waking during the night, insomnia. Morning wake up, headache on waking; Lastly, Sleep structure data: sleep onset latency, rapid eye movement, sleep latency, wake time after sleep onset, total sleep time, sleep efficiency, non-rapid eye movement, sleep time in stages N1, N2, and N3, REM sleep time, arousal, arousal per hour, respiratory disturbance index, apnea-hypopnea index; and Epworth Sleepiness Scale.

Eligibility Criteria:
Inclusion Criteria:

* Adults (aged 20 to 60 years) and elderly (aged \> 60 years) (WHO-World Health Organization, 2015) who were undergone to polysomnography (PSG) at the Pelotas Sleep Institute (PSI);
* Adequate cognitive capacity to understand and answer the questionnaire.

Exclusion Criteria:

• Those which the participants were unable to answer the questionnaires and who presented a history of epilepsy that could interfere in the results of PSG.
Study Evaluating Desvenlafaxine Succinate Sustained-Release (DVS SR) in Adult Outpatients With Major Depressive Disorder (MDD)

A multicenter, 8-week study to evaluate the efficacy of 2 doses (50 and 100 mg/day) of desvenlafaxine succinate sustained-release (DVS SR) versus placebo in adult outpatients with major depressive disorder.


Eligibility Criteria:
Inclusion Criteria:

* Male or female outpatients aged 18 years or older who are fluent in written and spoken English.
* A primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM- IV-TR), single or recurrent episode, without psychotic features.
* A HAM-D17 total score ≥20 at the screening and baseline (study day -1) visits and no more than a 4-point improvement from screening to baseline.

Exclusion Criteria:

* Significant risk of suicide based on clinical judgment.
* Current (within 12 months before baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder.
* Current generalized anxiety disorder, panic disorder, or social anxiety disorder.
* History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs.
* Any unstable hepatic, renal, pulmonary, cardiovascular, ophthalmologic, neurologic, or other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results.
Safety and Efficacy of NTX-001 Compared to SOC in Acute Single Peripheral Nerve Injuries

NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of severed nerves in patients between 16 and 80 years of age.

NTX-001 (Product) is a surgical product that consists of an active solution (drug), an isolation chamber medical device (chamber or device) and two (2) other sterile solutions.

NTX-001 has been developed as a surgical product to be used in conjunction with standard suture neurorrhaphy of a severed nerve. Use of NTX-001 is intended to safely accelerate the often slow and diminished return of function in repaired nerves. It often takes months and/or years to determine if function will be restored. By that point, restoration is often incomplete and can result in lifelong motor and/or sensory deficits. By reconnecting (PEG-fusion) a substantial number of axons within a severed nerve, the degeneration-regeneration cycle and subsequent atrophy may be reduced or even prevented for those axons and their targets, respectively. NTX-001 (PEG-fusion) has the potential to avoid the consequences of protracted denervation of distal target tissues by eliminating the period of total denervation thus reducing the time to stable recovery and providing greater innervation to affected tissues.

Eligibility Criteria:
Inclusion Criteria:

* The subject is at least 12 years of age and not older than 80.
* The subject has sustained a confirmed (intra-op assessment) single transected peripheral nerve injury.
* The subject's nerve injury is classified as Sunderland's Fourth and Fifth Degree (Class III)
* The subject's nerve injury is amenable to minimal or acceptable tension, in direct, end-to-end repair.
* The surgical repair will occur within 48 hours of injury.

Exclusion Criteria:

* The subject has a PNI with a segmental loss (gap) that cannot be repaired with minimal or acceptable tension.
* Other treatments known to affect the growth and/or physiology of the neural and vascular system.
* The nerve injury has vascular damage that cannot be repaired to provide adequate perfusion of the injured site.
* The subject is pregnant and/or is breastfeeding.
* The subject has a significant medical comorbidity precluding immediate repair.
VISmodegib for ORbital and Periocular Basal Cell Carcinoma

Basal cell carcinoma (BCCA) is the most common human cancer, and frequently affects facial structures. While rarely fatal, facial BCCA can be disfiguring and expensive to treat.

Vismodegib is a small molecule inhibitor of SMO developed for the treatment of tumors in which the Hh signaling pathway appears to contribute to the development and maintenance of tumorigenesis. Vismodegib was recently approved by the Food and Drug Administration (FDA) for treatment of metastatic and locally advanced BCCA. Recent reports have suggested that vismodegib treatment for orbital BCCA may facilitate eye preservation even if surgery is eventually required

In order to assess the potential of vismodegib to improve the ophthalmic outcomes following treatment for orbital and/or periocular BCCA, this study will follow patients with globe-threatening orbital and lacrimal-threatening periocular BCCA who are being treated with vismodegib as standard of care.

Patients with tumors that do not respond to treatment with Vismodegib, and those who have a good response but poor tolerance of Vismodegib, will be offered surgical excision of the tumor. Patients with a good response and good tolerance of Vismodegib may continue the treatment as long as clinically indicated.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients over 18 years of age with locally advanced or recurrent orbital or periorbital basal cell carcinoma (BCCA), or a medial canthal BCCA that threatens the lacrimal drainage system.
* Clinical assessment score obtained at baseline.
* Medical Oncology screening performed at baseline.
* Adequate BCCA size and location.
* Adequate hematopoietic capacity, hepatic and renal function.
* Male patients must agree to use condoms during treatment and for 3 months after last dose.
* Male patients must agree to not donate sperm during treatment and for 3 months after last dose.
* Participant must agree not to donate blood during the study and for 7 months after last dose.
* Informed consent signed.
* If the patient consents to enroll, then blood will be drawn and stored for biomarker analysis.

Exclusion Criteria:

* Inability or unwillingness to swallow capsules.
* Inability or unwillingness to comply with study procedures.
* Pregnant, lactating, or breast feeding women.
* Women of childbearing potential.
* Uncontrolled medical illness.
* Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
* Age under 18 years.
Determining the Depth of Endotracheal Tube Insertion

1. Airway length from the medial incisor to carina is divided into four segments ; the length from medial incisor to mouth angle, mouth angle to epiglottis, epiglottis to vocal cords and vocal cords to carina.
2. Determining the mean length of each segments with the direct laryngoscope, videolaryngoscope and fiberoptic bronchoscope at the time of endotracheal intubation.
3. Making a new formula to determine the proper individualized depth of intubation on the basis of the length of segments
4. Virtual experiment : comparing the new formula with conventional method of determining the depth of endotracheal intubation


Eligibility Criteria:
Inclusion Criteria:

* Patients who are scheduled to take general anesthesia with endotracheal intubation

Exclusion Criteria:

* Patients undergoing general anesthesia with face mask ventilation or laryngeal mask airway