cyrilzakka/clinical-trials huggingface dataset:
Prognostic Value of Aβ Imaging in NPH Prior to Shunt Placement

In this pilot study the investigators shall prospectively in a blinded fashion evaluate with Aβ PET in patients committed to shunt surgery and then investigate the relationship of these biomarkers with outcome on gait, cognition and urinary control improvement in the short term (3 months) and long term (1 year). The imaging agent will be provided by AVID.

Furthermore the study will standardize imaging studies using florbetapir F 18 PET to provide information on amyloid burden.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 60.
2. Visual and auditory acuity adequate for neuropsychological testing.
3. Completed six grades of education or has a good work history (sufficient to exclude mental retardation).
4. Must speak English fluently.
5. Willing to undergo one Amyloid imaging PET scan.
6. Agrees to at least one lumbar puncture for the collection of CSF.
7. Must agree to return for a Month 3 and Month 12 visit.
8. Participant, who in the opinion of the investigator, can tolerate the PET scan procedures

Exclusion Criteria:

1. History of schizophrenia (DSM IV criteria).
2. History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria).
3. Participation in clinical studies involving neuropsychological measures being collected more than one time per year.
4. Exclusion for amyloid imaging with 18F -AV-45: Current or recent participation in any procedures involving radioactive agents such that the total radiation dose exposure to the participant in any given year would exceed the limits of annual and total dose commitment set forth in the US Code of Federal Regulations (CFR) Title 21 Section 361.1.
5. Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances as indicated by history, which in the opinion of the investigator might pose a potential safety risk to the participant?
6. Current clinically significant cardiovascular disease, including one or more of:

   * cardiac surgery or myocardial infarction within the last 4 weeks;
   * unstable angina;
   * acute decompensated congestive heart failure or class IV heart failure
Effect of Tetracycline Pleurodesis on Prevention of Primary Spontaneous Pneumothorax Recurrence

Primary spontaneous pneumothorax (PSP) defines as presence of air in chest cavity occurs most commonly in young, tall, and smoker men without underlying lung disease.

Trends for PSP treatment tend toward more invasive procedures. Thoracotomy with pleurectomy and bullectomy is definitive treatment of PSP which significantly reduces recurrence probability. This procedure has been reported to cause high rate of morbidity and mortality. Thus video-assisted thoracoscopic surgery (VATS) has become the preferred method for treatment of PSP with recurrence rate of 5-10%. For persistent or recurrent cases, mechanical or chemical pleurodesis have been suggested.

Based on guidelines patients with large size of lesions in CT or with unstable condition should undergo surgical procedure for recurrence prevention but Patients with small lesion size and stable condition can be only observed. Conservative management of PSP is safe and effective, but as mentioned this method has high recurrence rate. On the other hand fear of recurrence can negatively affect patients' quality of life, so that some patients prefer surgical intervention to observation management. Also some studies recommend invasive treatments because of cost effectiveness of this methods.

As mentioned above, chemical pleurodesis is a usual method for treatment in patients with persistent or recurrent spontaneous pneumothorax. This method has been done using variety of chemical agents including tetracycline, minocycline, blood, and talc to irritate pleura. According to different studies tetracycline has the highest efficacy between irritant agents.

In current study, the investigators have aimed to assess tetracycline chemical pleurodesis through tube thoracostomy in prevention of spontaneous pneumothorax in symptom free patients with normal CT-scan following first episode of PSP.


Eligibility Criteria:
Inclusion Criteria:

* First episode of primary spontaneous pneumothorax
* Do not have bullae in CT-scan
* No history of chest trauma or thoracic surgery

Exclusion Criteria:

* History of chest trauma or thoracic surgery and start/quiting of smoking during past year.
* Not willing to participate in the study
Clinical Outcomes of Percutaneous Nephrolithotomy Following Retrograde Percutaneous Nephrostomy Access Using Novel Device in Comparison to Antegrade Access

The purpose of this study is to compare relevant clinical outcomes in patients requiring percutaneous nephrostomy for urolithiasis treatment between those who undergo an antegrade approach versus a retrograde approach and to determine which clinical characteristics predict success of lithotomy with anterograde or retrograde percutaneous nephrostomy approaches.


Eligibility Criteria:
Inclusion Criteria:

-Renal pelvis and proximal ureteral stones \>10 mm confirmed with non-contrast computed tomography

Exclusion Criteria:

* Suspected pyelonephritis.
* Prior percutaneous nephrolithotomy procedure in affected kidney.
* Mid-ureteral or distal ureteral stones.
* Pregnancy.
* Anatomical abnormal kidney, including:

  * Horseshoe
  * Ectopic
Evaluation of the Relationship Between Airway Measurements and Laryngoscopic View in Newborn and Infants

Background and Aim: The overall incidence of difficult laryngoscopy in pediatric anesthesia is lower than in adults, but this risk is higher in patients younger than one year of age. In the last decade, different measurements have been used to obtain difficult laryngoscopy markers in children. In this study, we aimed to evaluate the relationship between the airway measurements (some performed by using ultrasonography (USG)) and the difficult laryngoscopic view in neonates and infants.

Design: This is a prospective, single blinded, observational study. The number of patients was calculated as follows: A sample of 12 from the positive group (difficult laryngoscopy group) and 96 from the negative group (easy laryngoscopy group) achieve 80% power to detect a difference of 0.25 between the area under the ROC curve (AUC) under the null hypothesis of 0.50 and an AUC under the alternative hypothesis of 0,75 using a two-sided z-test at a significance level of 0.05.

Methods: All patients which is newborn and infant age group undergoing elective surgery requiring intubation under general anesthesia are assessed. Patients' age, body mass index (BMI), thyromental distance, mandibula length, the distance between the lip corner and ipsilateral ear tragus, and the transverse length (measured by hand sign-middle-ring fingers adjacent side by side) measurements are recorded. In thyromental distance measurement, "thyroid notch" are determined by USG.

The laryngoscopic view is graded by a different experienced anaesthetist who is blinded to the airway measurements.

Statistical analysis:

Receiver operating characteristic (ROC) curves are used to determine the best cut-off point for distance variables in the separation of difficult and easy laryngoscopy groups. Sensitivity, selectivity, positive predictive value and negative predictive values of lengths are calculated according to determined cut point.The difference between the two groups in terms of qualitative variables are evaluated by chi-square or Fisher's exact test. The normal distribution of the numerical variables are examined with the Shapiro-Wilk test. The difference between the two groups in terms of numerical variables are investigated by Mann Whitney U test. Values of p \<0.05 are considered as statistically significant.


Eligibility Criteria:
Inclusion Criteria:

* Newborn and infant age group
* Undergoing elective surgery requiring intubation under general anesthesia

Exclusion Criteria:

* History of congenital maxillofacial defect,
* History of upper airway pathology (tumor, cleft palate-lips, etc.)
* History of head and neck trauma (fracture, swelling, scar )
Trial of Perioperative Chemotherapy (Gemcitabine and Cisplatin) and Adjuvant Chemoradiotherapy (With Weekly Low Dose Gemcitabine) in Patients With Lung Cancer With Positive Nodes

The purpose of this study is to test feasibility, toxicity and efficacy of two different adjuvant treatment schedules in Stage II-IIIa Non-small cell lung cancer patients with positive lymph nodes.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of NSCLC (any subtype). For patients entering Arm B is also allowed to confirm histopathological diagnosis of NSCLC intraoperatively during this trial.
* Node positive (clinically or pathologically) stage II disease or Stage IIIA: T1N1 or T2N1 or T1N2 or T2N2 or T3N1 or T3 N2, according to the revision by Mountain CF of American Joint Committee on Cancer (Mountain CF 1997, Fleming ID et al. 1997). For patient entering Arm B (with N0 stage) confirmation of N1-N2 stage must be obtained from intraoperative or post-surgery pathology report.
* Tumor amenable to curative surgical resection.
* Patients with clinically measurable lesions will be enrolled in this study. Measurability is determined according to RECIST criteria.

  • Pathological evaluation is performed after mediastinoscopy or after surgery
* No prior tumor therapy (surgery, radiotherapy, chemotherapy, immunotherapy, molecular targeted therapy, or any other type of tumor therapy).

Exclusion Criteria:

* Treatment within the last 30 days with any investigational drug.
* Concurrent administration of any other tumor therapy, including radiotherapy, cytotoxic chemotherapy, immunotherapy, molecular target therapy.
* Serious concomitant disorders (for example, heart failure, poorly controlled diabetes) at the investigator's discretion.
* Presence of an uncontrolled, active infection requiring therapy (at the discretion of investigator.).
* Stage IIIb or IV.
Efficacy and Safety of Cinacalcet in Pediatric Patients With Secondary Hyperparathyroidism (SHPT) and Chronic Kidney Disease (CKD) on Dialysis

The primary objective was to evaluate the efficacy of cinacalcet for reducing the plasma intact parathyroid hormone (iPTH) level by ≥ 30%.

This was a 24-week, randomized, multicenter, open-label, controlled study. Participants were randomized into one of two treatment arms; oral administration of cinacalcet daily in addition to standard of care treatment, or standard of care alone. Randomization was stratified by age group (6 to \< 12 and 12 to \< 18 years of age). All participants received standard of care which could include therapy with Vitamin D sterols, calcium supplementation, and phosphate binders.

Participants in both treatment groups who completed the 20-week treatment period and those who ended the study due to study closure were eligible to enroll in an open-label extension study (20140159; NCT02341417) for further safety follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age 6 - \< 18 years
* Diagnosis of SHPT with the mean of the two consecutive central laboratory iPTH values ≥ 300 pg/mL during screening
* Corrected calcium value of ≥ 8.8 mg/dL during screening
* Diagnosis of CKD, receiving either hemodialysis or peritoneal dialysis, for ≥ 30 days prior to screening
* Parent or legally acceptable representative has provided written informed consent and subject has provided written assent when required by institutional guidelines

Exclusion Criteria:

* History of congenital long QT syndrome, second or third degree heart block, ventricular tachyarrhythmias or other conditions associated with prolonged QT interval
* Corrected QT interval (QTc) \> 500 ms, using Bazett's formula
* QTc ≥ 450 to ≤ 500 ms, using Bazett's formula, unless written permission to enroll is provided by the investigator after consultation with a pediatric cardiologist
* Use of grapefruit juice, herbal medications, or potent cytochrome P450 3A4 (CYP3A4) inhibitors (eg, erythromycin, clarithromycin, ketoconazole, itraconazole)
* Use of concomitant medications that may prolong the QTc interval (eg, ondansetron, albuterol)
GF-GS 01: Comparing Conventional Axillary Dissection Versus Sentinel Node Resection in Clinically Node-negative Operable Breast Cancer

Sentinel node resection appears as a promising advancement in the surgical treatment of breast cancer.

The GF-GS 01 study, sponsored by a National Hospital Research Program, compares this new surgical method with a classical method in patients having a negative sentinel node.

The duration of the follow-up is 5 years.


Eligibility Criteria:
Inclusion Criteria:

* Women older than 18 years with clinically node-negative operable unifocal N0 breast cancer (clinical tumour size \< 30 mm).
* Written consent is obtained from all patients before randomization.
Diagnostic Assessment of Amino Acid PET/MRI in the Evaluation of Glioma and Brain Metastases

MRI is used in clinical routine for diagnosing brain tumors, but has limitations in identifying tumor grade, true tumor extension and differentiate viable tumor tissue from treatment induced changes and recurrences.

Amino acid PET has demonstrated a great potential for defining true tumor volume, differentiate viable tumor tissue from postoperative changes or radiation necrosis, selection of biopsy site, non-invasive grading of gliomas and for treatment planning and therapy response assessment. By combining PET with MRI, the diagnostic accuracy can improve significantly for these patients. More research is however needed to compare the most promising amino acid PET tracers in patients with glioma, but also to assess the diagnostic value of amino acid PET in patients with different brain metastases, where the knowledge concerning the uptake characteristics is limited.

Three of the most promising amino acid tracers (\[11C\]-methyl-methionine (11C-MET), \[18F\] fluoro-ethyl-tyrosin (18F-FET) and anti-1-amino-3-\[18F\]fluorocyclobutane-1-carboxylic acid (18F-FACBC)) will be evaluated in 3 substudies in this project; WP1 Aminoacid PET/MRI in low and high grade glioma; WP2 Role of 11C-MET in high-grade glioma Gamma Knife® radiosurgery; and WP3 Amino acid PET in brain metastasis.

The main aim of the study is to improve diagnostic accuracy, histopathological tissue sampling, delineation of tumor extent and therapy response assessment in gliomas and brain metastases with amino acid PET/MRI.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria Glioma (LGG, HGG and recurrent HGG):

  * Planned treatment for WHO grade II-IV diffuse glioma
  * Adult patients (\>18 years)
  * Planned tissue sampling for histopathological diagnosis.
  * KPS \>60 (able to care for self)

Inclusion criteria Brain Metastasis:

* Indication of surgery or stereotactic radiosurgery for 1-4 brain metastases
* Planned surgery: Suspicion of brain metastasis or known diagnosis
* Stereotactic surgery: Known primary cancer
* Adult patients (\>18 years)
* Estimated survival at least 3 months after inclusion

Exclusion Criteria:

* Exclusion criteria (Glioma and Brain Metastasis):

  * Pacemakers or defibrillators not compatible with 3T MRI
  * No ability to obtain informed consent (e.g. due to severe dysphasia or cognitive deficits).
  * Pregnancy (pregnancy test for all women in fertile age when doubt about possible pregnancy exist)
  * Breastfeeding
  * Weight \> 120 kg
Post-discharge Outcomes of Pediatric Acute Respiratory Distress Syndrome

In this study, the investigators aim to better characterize the outcomes of pediatric acute respiratory distress syndrome (PARDS) survivors, to examine whether subgroups of children with PARDS can be identified, and to determine whether an earlier diagnosis of PARDS using a computerized decision support system will improve the care of these children.

Pediatric acute respiratory distress syndrome (PARDS), a heterogeneous clinical syndrome characterized by acute lung injury and hypoxemia, affects up to 10% of pediatric intensive care unit (ICU) patients and has a mortality rate of 18-27%. Because children who survived PARDS are still developing, long-term morbidities are highly relevant, although data on the outcomes of PARDS survivors is lacking. Previous studies were limited by their sample size, were outdated in PARDS management strategies, and used the adult ARDS diagnostic criteria. Some studies focused on pulmonary function but not on other patient-oriented outcomes such as respiratory symptoms, mental health issues, quality of life, and health care resource use, all of which have been identified as prevalent issues in adult ARDS survivors. Recently, adult studies have identified 2 distinct ARDS subphenotypes with differential responses to treatment using clinical and limited biological data, providing insight on the pathophysiology of ARDS. Whether these phenotypes are present in PARDS is unknown. Furthermore, integrating newer technologies such as transcriptomics in the identification of subphenotypes may improve our understanding of disease mechanisms. Finally, delays in ARDS diagnosis are common and compliance with current ARDS ventilation management guidelines is poor, ranging from 20-39% even in patients selected for clinical trials. Thus, novel methods such as decision support systems may play a role in the diagnosis and management of PARDS patients, although this remains to be evaluated.

Eligibility Criteria:
Inclusion criteria:

* clinical diagnosis of PARDS, as defined by PALICC
* aged less than 18 years
* admitted to the intensive care unit

Exclusion Criteria

- none
Local Infiltration Analgesia or Intrathecal Morphine in Total Knee Arthroplasty

The purpose of this study is to determine whether local infiltration analgesia is more effective than intrathecal morphine in reducing postoperative pain in total knee arthroplasty.

Postoperative pain is often severe following total knee arthroplasty. Spinal anesthesia is a common method in total knee arthroplasty. Adding morphine to the local anesthetic injected intrathecally prolongs the analgetic effect, but may give the usual opioid side effects. The Local Infiltration Analgesia (LIA) technique has proven effective in reducing postoperative pain in total knee arthroplasty. In the LIA technique a long-acting local anesthetic (ropivacaine), a nonsteroidal anti-inflammatory drug (ketorolac), and epinephrine are infiltrated intraoperatively and via an intraarticular catheter postoperatively.

The aim of this study is to evaluate if spinal anesthesia together with the LIA technique provide better postoperative pain relief and mobilization than spinal anesthesia with addition of morphine to the local anesthetic intrathecally. Primary end-point is morphine consumption the first 48 postoperative hours. Secondary end-points are pain intensity, knee function, time to home readiness, hospital stay, side effects and patient satisfaction. Patients are followed up to 3 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for total knee arthroplasty under spinal anesthesia.
* Aged 40-85 yrs.
* ASA physical status I-III and mobility indicating normal postoperative mobilization.

Exclusion Criteria:

* Known allergy or intolerance to one of the study drugs.
* Serious liver-, heart- or renal decease.
* Rheumatoid arthritis.
* Chronic pain or bleeding disorder.
A Study in Rheumatoid Arthritis Patients Who Have Completed a Preceding Study With ABBV-105 Given Alone or in Combination With Upadacitinib

This was a long-term extension (LTE) study to assess the safety, tolerability, and efficacy of ABBV-105 (elsubrutinib \[ELS\]) and ABBV-599 (ELS 60 mg and upadacitinib \[UPA\] 15 mg) in participants with rheumatoid arthritis (RA) who completed Study M16-063 (NCT03682705).

This was a Phase 2, double-blind, multicenter, long-term extension (LTE) study to assess the safety, tolerability, and efficacy of 3 doses of ABBV-105 (elsubrutinib \[ELS\] 5 mg, 20 mg, and 60 mg) and ABBV-599 (ELS 60 mg and upadacitinib \[UPA\] 15 mg) in adults with active rheumatoid arthritis with inadequate response or intolerance to biologic disease-modifying antirheumatic drugs (bDMARDs). Participants who successfully completed treatment in the feeder Study M16-063, a Phase 2 dose exploratory study, were eligible to participate in this study. Those who met eligibility criteria and entered this study receiving ELS, ABBV-599, or UPA from Study M16-063 continued on their previously assigned treatment through termination of this study. Participants originally randomized to placebo in Study M16-063 rolled over to ABBV-599 in a blinded fashion in this study.

Eligibility Criteria:
Inclusion Criteria:

* Participant has completed Study M16-063
* Participant has not developed any laboratory or clinical discontinuation criteria as defined in the Study M16-063 protocol
* Participant is willing and/or able to comply with procedures required in the current study protocol

Exclusion Criteria:

* Participant is currently enrolled or planning to enroll in another interventional clinical study while participating in this study (except the preceding study M16-063)
* Participant requires vaccination with any live vaccine during study participation, including at least 30 days after the last dose of study drug
Compassionate Use Study of Two Dose Levels of Thalidomide in Adults With HIV Wasting Syndrome

To allow patients with HIV-associated wasting to receive thalidomide treatment at 1 of 2 doses. To gain safety and efficacy data from a broader base of patients with HIV-associated wasting in order to support Celgene's pivotal placebo-controlled study.

Patients are randomized to receive thalidomide at 1 of 2 doses for 12 weeks initially, with response assessed at weeks 2, 4, 8, and 12. Patients failing the low dose will be eligible to increase the dose to the higher dose. Treatment may continue indefinitely. After 12 weeks, patients continuing treatment are evaluated every 2 months for up to 6 additional months, then every 6 months thereafter.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication:

Allowed:

* Antiretroviral therapy.
* Prophylaxis or treatment for opportunistic infection.

Patients must have:

HIV-associated wasting.

Prior Medication:

Allowed:

* Prior enrollment on Celgene's placebo-controlled thalidomide study, provided patient meets specified criteria for not continuing on that study.
Effects of Digital Therapeutic in Whole Process Management of Lung Cancer

This trial will randomize patients into two groups, the treatment group will use the digital therapeutic application named 'UHealth' for the whole process management and the control group will use regular follow-up. The trial aims to look into the difference between quality of life, anxiety/depression index, emergency treatment times, hospital admission rate, treatment compliance, OS, DFS and follow-up cost.


Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically or cytologically confirmed lung cancer;
* Patients have received surgery, neoadjuvant therapy, adjuvant therapy, radiotherapy or other chemotherapy, such as cytotoxic chemotherapy, targeted therapy and immunotherapy;
* ECOG (Performance status) 0-1;
* Patients aged \> 18 years and \< 70 years;
* The patients themselves or their family members are familiar with mobile and internet;

Exclusion Criteria:

* Patients have disease progression in the screening period;
* Patients with symptomatic brain metastasis;
* Patients with dementia, schizophrenia or other psychological diseases that may affect the cognitive behavior;
* Other medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information;
* Women who are pregnant or in the period of breastfeeding.