cyrilzakka/clinical-trials huggingface dataset:
Differential Sensory Block During Labor Epidural Analgesia: a Prospective Observational Study to Investigate the Relationship of Lower and Upper Sensory Block Levels to Cold With Sensory Block to Pinprick and Light Touch

Epidural analgesia remains the gold standard for pain control during labor and delivery. Proper assessment of an epidural's level of blockade is important for providing safe and effective analgesia. Previous studies have established that the most commonly tested modality for adequacy of epidural blockade is a patient's sensory blockade to cold temperature. In a study performed at our institution, Soares et. al. (publication pending) documented two thresholds of sensory block to ice: one defined as the lower sensory block level, in which the patient is able to notice the cold sensation but perceives that it is not as cold as a control dermatome; the other defined as the upper sensory block level, in which the patient perceives that the cold sensation is at approximately the same temperature as if it were applied to a non-anesthetized area such as the neck or face. Although this a known finding to nurses and physicians assessing the sensory block to ice, this phenomenon and its magnitude has not been previously reported in epidural anesthesia. The goal of this study is to examine patients with labour epidurals and to determine the dermatomal relationship between the lower and upper sensory block levels to cold when compared with sensory blockade to both pinprick and light touch.


Eligibility Criteria:
Inclusion Criteria:

* ASA Physical Status Classification II and III parturients
* Requested and received a labour epidural
* Capable of consenting to the study
* Have no language barrier which may obfuscate the sensory block assessment
* Are receiving programmed intermittent epidural boluses (PIEB) for maintenance analgesia, which is the Mount Sinai Hospital default maintenance regimen

Exclusion Criteria:

* Medical comorbidities that could compromise the body's sensitivity to cold, pinprick, or touch
* Epidurals performed under a combined spinal-epidural (CSE) or dural puncture epidural (DPE) technique
* Epidurals with a documented unintentional dural puncture
* Inadequate epidural analgesia requiring either manually administered epidural boluses, an increase in the concentration of their maintenance local anesthetic, or a repeat of their epidural
Effectiveness and Tolerability of Phentermine in Patients Under Bariatric Surgery

Surgical management of Morbid Obesity is increasingly frequent. A low-calorie diet is recommended with the main goal of reducing intrahepatic fat infiltration, fat tissue and making easier the surgery. Information the use pharmacological interventions during the preoperative period in this population are rare.

This is a randomized, control trial to investigate the effect and safety of Phentermine in patients with obesity who need a bariatric surgery (BMI \>35 kg/m2 with comorbidities or BMI \> 40 kg/m2).

Screening will be made to select eligible participants before intervention. Participants were randomly assigned to one of two groups (low-calorie diet + phentermine 15 mg or low-calorie diet + placebo) for therapies during 6 weeks. Anthropometric measurements (weight, body composition, body mass index and waist-hip index), serum metabolic profile (glucose, total cholesterol, HDL-c, LDL-c, triglycerides, and HOMA-IR) markers of inflammation (IL-1, IL-6 and PCR) and hepatic ultrasound will be measured 2 times for each participant. Surgical complications (anastomosis filtration, intestinal obstruction or stenosis, need to perform open surgery and mortality) will be evaluated. Adverse events associated with phentermine (blood pressure, cardiac frequency, headache, gastrointestinal symptoms, euphoria, anxiety and insomnia) will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Women and men
* \>18 years and \<55 years old.
* Diagnosis of obesity grade II with comorbidities
* Diagnosis of obesity grade III with or without comorbidities
* Approved to bariatric surgery by an interdisciplinary committee
* Having signed the Informed consent form

Exclusion Criteria:

* Use of addictive substances

  * Inability or lack of understanding to achieve lifestyle and behaviour changes
  * Mental disease
  * Severe Pulmonary disease
  * Giant Hiatal hernia, gastric or duodenal ulcer
  * Unstable coronary artery disease
  * Portal hypertension or esophageal varices
  * Surgical or anesthetic high risk
Association Between the Results of Specific Genetic Tests and the Efficacy of Targeted Therapies in Patients

Our study aimed to evaluate the correlation between test reagent specific gene test results and the efficacy of relevant targeted drugs in patients with non-small cell lung cancer, and to support the continued registration of test reagents.


Eligibility Criteria:
Inclusion Criteria:

* 1)≥18，advanced non-small cell lung cancer confirmed by histopathology, and were previously or currently treated with gefitinib tablets (as the first-line treatment) or osimertinib (first-generation TKI resistance treatment) or crizotinib capsules monotherapy were evaluated for efficacy.
* 2) Able to provide FFPE samples with a storage life of 5 years: Large specimen 5 pieces in each case; 10 puncture specimens in each case

Exclusion Criteria:

* 1) Pathological evaluation of the tissue sample has too few tumor cells (total number of tumor cells \>20%);
* 2) Combination therapy with chemotherapy/radiotherapy/other targeted drugs/immunotherapy drugs;
* 3) Maintenance treatment when the disease does not progress after other anti-tumor treatments.
Long-Term Cognitive Decline After Coronary Artery Bypass Grafting: is Off-Pump Surgery Beneficial?

Coronary artery bypass surgery is associated with postoperative cognitive decline, which has largely been attributed to the use of the heart lung machine. We hypothesized that long-term cognitive outcome may improve by avoiding the heart lung machine. The objective of the present study is to compare the effect of coronary bypass surgery with and without heart lung machine on cognitive and clinical outcome, five years after surgery.

Background:

Coronary artery bypass surgery is associated with postoperative cognitive decline, which has largely been attributed to the use of cardiopulmonary bypass (CPB). A large recent study by Newman et al demonstrated that the incidence of cognitive decline was 24% at six months after surgery, but it increased to 42% at five years. In the recently conducted Octopus Randomized Trial, cognitive decline at three months after surgery was present in 29% of the patients operated with CPB. In the patients operated without CPB, the incidence was 21%, i.e. only slightly better.

Hypothesis:

Improvement of cognitive outcome by avoiding cardiopulmonary bypass will become more apparent five years after surgery, compared to three months after surgery.

Study objectives:

The objective of the present study is to compare the effect of coronary bypass surgery with and without cardiopulmonary bypass on cognitive and clinical outcome, five years after surgery.

Methods:

The 281 participants of the Octopus Study, who were operated on between March 1998 and August 2000 and randomized to off-pump or on-pump coronary bypass surgery, will be invited for an additional assessment of their cognitive and clinical status and quality of life, five years after surgery. Patients will undergo a battery of ten neuropsychologic tests to determine their cognitive status. Clinical status will be assessed by an interview. Questionnaires will be used to measure quality of life.

Eligibility Criteria:
Inclusion Criteria:

* indication for (first-time) coronary artery bypass surgery
* off-pump CABG considered technically possible

Exclusion Criteria:

* concomitant valve surgery
* unable to complete neuropsychological testing
* life expectancy less than 1 year
Clinical Trial to Assess Influence of MyCyFAPP Use on GI Related QOL in Children With Cystic Fibrosis

Interventional trial to study the influence of the use of MyCyFAPP (mobile application) on the gastro-intestinal related quality of life.

This mobile APP has been developed during previous workpackages of the Horizon2020 Project and contains several modules:

* mathematical prediction model to calculate the needed dose for pancreatic enzyme replacement therapy
* educational games and other educational material
* communication with doctor/dietician through professional webtool
* diary to register symptoms and data on nutrition.

The app will be introduced and used during 6 months. Primary outcome parameter will be change in modified PedsQL GI after 3 months. PedsQL GI is an existing questionnaire that evaluates gastro-intestinal related quality of life in children. We validated it for use in cystic fibrosis in a previous observational study.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of CF as evidenced by one or more clinical feature consistent with the CF phenotype or positive CF newborn screen AND one or more of the following criteria:

   1. A documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis (QPIT)
   2. A documented genotype with two disease-causing mutations in the CFTR gene
2. Having pancreatic insufficiency (stool elastase \< 200 mcg/g stool) and using PERT
3. Age ≥ 24 months and \< 18 years at screening visit
4. Informed consent by parent or legal guardian; assent for children from age 12 years on

6. Inclusion visit coincides with scheduled routine clinic visit 7. Ability and willingness to comply with APP use and evaluations at time of routine clinic visits as judged by the site investigator 8. Availability of wifi connection at home so that connection to the internet is feasible at home at least weekly.

Exclusion Criteria:

1. Acute infection associated with decreased appetite or fever at time of run-in visit
2. Acute abdominal pain necessitating an intervention at time of run-in visit
3. Physical findings that would compromise the safety of the participant or the quality of the study data as determined by site investigator
4. Investigational drug use within 30 days prior to run-in visit
5. Started with CFTR modulator treatment less than 3 months before start of run-in visit
6. Inability to use the APP due to patient specific factors such as language or learning difficulties
Pain Satisfaction Survey

The purpose of this study is to survey pain management satisfaction in patients with non-cancer pain.

This is a multi-center, Observational study consisting of a one time survey to assess pain management satisfaction for patients with non-cancer pain. The purpose of this study is to develop a large clinical database for the results of the pain management satisfaction questionnaire. All information collected from hospitals will be used to evaluate patient satisfaction of pain management and to improve the quality of life for patients with non-cancer pain Observational study - No study drug administered

Eligibility Criteria:
Inclusion Criteria:

* Patients who have visited out patient department (OPD) and who are actively treated for pain

Exclusion Criteria:

* Patients with cancer pain
* Patients with known or suspected psychotic disease or mental retardation
Electronic Archive of Internal Medicine for the Treatment of Severe Organ Failure and Liver Transplantation-MITIGO

ELECTRONIC ARCHIVE OF INTERNAL MEDICINE FOR THE TREATMENT OF SERIOUS ORGAN FAILURES AND LIVER TRANSPLANTATION

This is an observational, spontaneous, monocentric study with structured data collection from the medical records of patients diagnosed with acute or chronic liver failure. The study will involve both retrospective and prospective data collection:

Retrospective data collection: Patients diagnosed between 01/01/2013 and the start date of the study.

Prospective data collection: Patients diagnosed after the start of the study until the end of the recruitment period (10 years).

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute or chronic liver disease or LT
* Age ≥ 18 years
* Obtaining informed consent

Exclusion Criteria:

* no one
The Effect of Preoperational Hand Massage Anxiety Level And Hemodynamic Variables

The study was conducted randomly controlled experimental to determine the effect of hand massage applied to pre-operative children on anxiety level and physical symptoms of anxiety.

On operation morning, "Child and Parent Introduction Form", "State-Trait Anxiety Inventory for Children" were read to and "Physiological Symptoms of Anxiety Inspection Form" measurement was done on children in both groups, and their 1st measurement values were recorded. Routine treatment and nursing care applications of the service were done preoperationally. After the researcher and the children in study group sat on a chair facing each other, hand massage procedure, 8 minutes to both hands and a total of 16 minutes hand massage was applied with liquid petrolatum. No massage was applied to children in control group. Right 16 minutes after the 1st filled forms in each group, "State-Trait Anxiety Inventory for Children", "Physiological Symptoms of Anxiety Inspection Form" were read, measurement was done and 2nd measurement values were recorded. Furthermore, "Satisfaction Evaluation Scale" was marked by those in study group after the massage, and measurement values were recorded.

Eligibility Criteria:
Inclusion Criteria:

* Agreeing to participate in the study and obtaining written permission from the family,
* Able to speak and understand Turkish,
* Not taking any analgesic and anesthetic drugs before the procedure,
* Over 9 years old and under 12 years old,
* whose parents are literate,
* Poor general condition and not needing emergency surgery (cases such as acute abdomen, intestinal perforations, traumas, etc.),
* There is no open wound on the skin or an obstacle to massage (edema, abscess, skin infection with necrosis, etc.),
* Thrombophlebitis, occlusive artery disease, fever etc. who do not have a situation in which massage application is objectionable due to illness, He does not have conditions such as loss of sensation, mass, fracture and ingrown nails in his hand,
* Children who are conscious, fully oriented and cooperative and open to communication

Exclusion Criteria:

* Those who do not accept to participate in the research and do not get written permission from their families,
* Does not speak or understand Turkish
* Taking any analgesic and anesthetic drugs before the procedure,
* Less than 9 years old and over 12 years old,
* illiterate parents
* Poor general condition and emergency surgery (acute abdomen, intestinal perforations, traumas, etc.) cases) need,
* Open wound on the skin or an obstacle to massage (edema, abscess, necrosis has occurred) skin infection etc.)
* Thrombophlebitis, occlusive artery disease, fever etc. massage practice due to illness having a situation where it is objectionable,
* Having conditions such as loss of sensation in the hand, mass, fracture and ingrown nails,
* Children who are unconscious, oriented and cooperative and not open to communication
Cannabis Vs Opioids Pain Management Objective Testing Comparisons

Our purpose for the study is to find safer, less intrusive, better preforming non-addictive products, as an alternative therapy for pain relief and to help alleviate the opioid epidemic ongoing in America today.

The AASEM nationally Sponsored/ Physicians Clinical Trial Policy CTP (Medicare study) testing results will be concluded by the Principal Investigators (MDs and DOs) of the study at each site authorized to participate by the AASEM, within the highest of scientific mathematical standards, using Pain DX Neural Scan and/or AXON II testing systems, which include amplitude testing certified with Promethius potentiometers, for Small Pain Fiber (SpF) Nerve Conduction Testing, CMS Carrier CPT codes 95904 now 95909 through 95913 units, as needed.

It is expected that, at a later date, other products used for therapy and/or rehabilitation purposes will be added to the comparison protocol for the National Trial Number (NCT# TBA) assigned by the National Library of Medicine (NLM). Other products and/or DME equipment may include: infrared light therapy CPT code 97026, TENS therapy and home units CPT therapy code # 97032, as well as montmorillonite minerals for physical applications (montmorillonite is a natural mineral and has no CPT code - is not a CMS ordinarily payable event).

Eligibility Criteria:
Inclusion Criteria:

* In the investigator's judgment a high probability of 5 year survival.
* Patient is able to comply with the study visit schedule.
* Patient has the ability to comprehend and sign an informed consent document prior to study enrollment.

Exclusion Criteria:

* In the investigator's judgment not a high probability of 5 year survival.
* Patient is unable to comply with the study visit schedule.
* Patient does not have the ability to comprehend and sign an informed consent document prior to study enrollment.
Effect of Intravenous Amantadine Sulphate on Disorders of Consciousness

Double-blind, placebo-controlled, crossover ("within subjects") study with an A-B-A-B treatment scheme to investigate the neuromodulatory effects of intravenous amantadine sulphate at a single daily dose of 200 mg in patients with disorders of consciousness (unresponsive wakefulness syndrome and minimally conscious state) by integrating traditional neurobehavioral assessment with spectral analysis of electrocortical activity derived from 64-channel electroencephalography (EEG) recordings.

Research hypothesis Intravenous amantadine sulphate treatment (200 mg) over five days improves consciousness, defined as an increase in CRS-r score of at least 3 points, and changes the band powers of the EEG in patients with disorder of consciousness admitted in a Neurorehabilitation Department.

Eligibility Criteria:
Inclusion Criteria:

Adults with disorders of consciousness due to acquired brain injury classified according to international guidelines based on CRS-R evaluation as unresponsive wakefulness syndrome/vegetative state (UWS/VS) or minimally conscious state (MCS) either in the subacute or chronic stage

Exclusion Criteria:

* Age \< 18 years
* History of epileptic seizures/status epilepticus
* Scalp defects
* pregnancy
* Severe uncompensated heart failure (NYHA IV)
* Atrioventricular block (AV block) second-degree and third-degree
* Known bradycardia (below 55 beats/minute)
* Known long QT interval (QTc according to Bazett \> 420 ms
* History of serious ventricular arrhythmias
* Hypokalemia or hypomagnesemia
* Impaired renal function
A Study Comparing Perioperative Stress Reduction vs. Standard of Care in Ovarian Cancer (PRESERVE)

The purpose of this study is to see if propranolol and etodolac along with mind-body resilience training/MBRT and music therapy help participants who are experiencing physiological stress before, during, and after primary debulking surgery/PDS or IDS and also if it's better than the standard-of-care approach (no intervention for reducing stress).


Eligibility Criteria:
Inclusion Criteria:

* Advanced (stage II-IV) epithelial ovarian, fallopian tube, or primary peritoneal carcinoma diagnosed on the basis of imaging, CA125, and clinical assessment
* Scheduled to undergo exploratory laparotomy and PDS or IDS
* Scheduled for surgery with at least 10 days of lead time, to allow the participant to take the β-blocker and COX2 inhibitor 7 days preoperatively
* Age ≥18 years
* ASA score of 1 to 3
* Ability to understand the study objectives and procedures, comply with the protocol, and provide informed consent

Exclusion Criteria:

* Chronic treatment with any β-blocker or COX inhibitor
* Contraindication for β-blocker therapy (asthma, second- or third-degree atrioventricular block, sinus bradycardia, sick sinus syndrome, right-sided heart failure, pheochromocytoma, peripheral vascular disease)
* Contraindication for COX2 inhibitor therapy (renal failure \[creatinine level \>1.5 mg/dL\], significant liver failure \[known cirrhosis, bilirubin level \>2\], active peptic disease), or current use of oral anticoagulant)
* Contraindication for regional epidural anesthesia
* Chronic autoimmune disease
* Active infection
* Pregnant
* Minimally invasive procedure
* Participation in another clinical trial that interferes with this study
iParent2Parent Program for Parents of Pediatric Solid Organ Transplant Recipients

The iParent2Parent (iP2P) program is a new, innovative virtual mentorship program that will connect parents one-to-one with other parents of pediatric solid organ transplant (SOT) recipients who are trained to offer vital peer support and mentorship. Parents of children who received a SOT at The Hospital for Sick Children will be invited to participate as mentors and mentees (randomized into the iP2P or control group). The iP2P program can decrease feelings of isolation, improve mental health and have a long-term positive impact on patient health. This research will increase our understanding of one-to-one peer support and leverage eHealth technologies to improve the access to and acceptability of parent peer support interventions.


Eligibility Criteria:
Mentee Inclusion Criteria:

* Parent of a patient under 18 years of age who received a solid organ transplant and is at least two months post-transplant,
* Access to a device (e.g., smart phone, tablet, computer) capable of using free WhatsApp software, and
* English-speaking.

Mentor Inclusion Criteria:

* Parent of a patient under 21 years of age who received a solid organ transplant and is at least one year post-transplant,
* Nominated by their child's healthcare team as a good candidate to act in the mentor role (e.g., good communication skills, positive adaptation and adjustment post-transplant, strong support network),
* Access to a device (e.g., smart phone, tablet, computer) capable of using free WhatsApp software, and
* English-speaking.

Exclusion Criteria:

* Non-English speaking.