cyrilzakka/clinical-trials huggingface dataset:
The Effect of Mask Combined With High Flow Oxygen on Preoxygenation During Induction of General Anesthesia in Obese Patients

There is a risk of airway-related incidents during anaesthesia associated with obesity. High-flow nasal oxygen is advocated for perioperative preoxygenation in obese patients to reduce airway adverse reactions. However, there have been no reports on whether smoking behaviors have an impact on obese men's Apnoeic oxygenation with high-flow nasal.This study compared the effects of smoking on the duration of safe apnoea times in obese males.

All patients were were divided into two groups based on smoking status: smokers(S groups), and never smokers(NS groups). Those in the smoking group were current smokers, while those in the nonsmoking group had never smoked. Both groups of patients were induced with intravenous anesthesia and received 5 minutes of high flow nasal oxygen (60 L min) prior to induction.After induction of anaesthesia, the patients were apnoeic until peripheral oxygen saturation decreased to 95 %.

Eligibility Criteria:
Inclusion Criteria:

1. Participants ranged in age from 18 to 80 with BMI≥30 kg/m2.
2. Participants are male obese patients undergoing elective non-thoracic surgery

Exclusion Criteria :

1. patients were kept awake during the intubation due to cervical spine pathology.
2. Patients with unstable hemodynamics.
3. Patients with airway inflammatory diseases, including asthma, chronic obstructive pulmonary disease (COPD), lung cancer, pulmonary fibrosis and cystic fibrosis.
4. Patients with upper respiratory infection and nasal blockage.
5. Patients with Hypersensitivity to the drug.
A Comparison of Temperature Measurement During Living Donor Liver Transplantation

The purpose of this study is to compare the temperature measured from the cuff surface of the endotracheal tube and core temperature measured at the esophagus in living donor liver transplantation recipients.

Hypothermia occurs frequently in patients undergoing surgery and is known to be related with many postoperative complications. Patients undergoing living donor liver transplantation are usually monitored using an esophageal stethoscope. However, because patients with liver cirrhosis have the risk of variceal bleeding, placement of an esophageal stethoscope can increase the risk of bleeding.

There have been previous reports that temperature monitoring at the cuff surface of an endotracheal tube is not only safe but also provides accurate and reliable data during mild hypothermia after cardiac arrest.

This study compares the temperature measured from the cuff surface of the endotracheal tube and core temperature measured at the esophagus and additionally core temperature measured by a pulmonary artery catheter. The study participants are intubated with an endotracheal tube that has a temperature sensor at the cuff surface of the tube. The rest of the procedure is done according to Seoul National University Hospital's protocol for liver transplantation: an esophageal stethoscope is placed for temperature monitoring and a central line is placed with a Multi-Access lumen Catheter and a pulmonary artery catheter is placed. The temperature measurements from the endotracheal tube and measurements from the esophageal stethoscope are compared at the following 5 phases: 1. preanhepatic phase, 2. anhepatic phase 1 (recipient hepatectomy - IVC clamping), 3. anhepatic phase 2 (IVC clamping - reperfusion), 4. Reperfusion phase, 5. Neohepatic phase.

Eligibility Criteria:
Inclusion Criteria:

* routine living donor liver transplantation recipients needing pulmonary artery catheterization who have been informed and given consent

Exclusion Criteria:

-
Internetbased Relapse Prevention for Partially Remitted Depression

The main purpose of the study is to test whether Internet-based relapse prevention plus medication has a better protective effect compared to medication only, for persons with residual depressive symptoms who are currently in paid employment or in education. We hypothesise that during the two years following the intervention:

* The persons in the group receiving Internet-based relapse prevention plus medication will be absent from work for fewer days due to sick-leave compared to those in the medication-only group.
* Fewer persons in the group receiving Internet-based relapse prevention + medication will experience long term sick-leave (60 days or more) compared to those in the medication-only group.
* The persons in the group receiving Internet-based relapse prevention plus medication will suffer fewer depressive relapses compared to those in the medication-only group.
* At follow-up, the persons in the group receiving Internet-based relapse prevention plus medication will have higher health related quality of life and lower levels of depressive symptoms compared to those in the medication-only group.


Eligibility Criteria:
Inclusion Criteria:

* Mild residual depressive symptoms (7-19 on the MADRS-S).
* A history of at least one episode of Major Depression.
* Currently in (at least) half-time employment, self-employment or education.
* Taking a stable (since one month) and therapeutic dosage of antidepressant medication
* Being able to read and write Swedish
* Having access to the internet

Exclusion Criteria:

* Fulfilling the criteria for Major depression
* Psychosis
* Substance abuse
* Suicidality
A Retrospective Analysis of Neck Dissection Following Complete Response to Chemoradiation in HNSCC

RATIONALE: Gathering disease-related information from medical charts of patients with primary head and neck cancer who have undergone neck dissection after complete response to chemotherapy and radiation therapy may help doctors learn more about the disease and find better methods of treatment.

PURPOSE: This clinical trial is evaluating the medical charts of patients with primary head and neck cancer who have undergone neck dissection after complete response to chemotherapy and radiation therapy.

OBJECTIVES:

* Perform a retrospective analysis, by medical chart review, of patients with primary squamous cell carcinoma of the head and neck who underwent neck dissection following complete response to chemoradiotherapy.
* Determine whether the role of a post-chemoradiotherapy neck dissection affects the outcome of the patient's disease, in terms of overall survival, disease-free survival, and recurrence rates.

OUTLINE: This is a pilot, retrospective study.

Patients who have undergone neck dissection after achieving a complete clinical and radiological response to chemoradiotherapy are compared to patients who did not. Data are gathered by medical chart review.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary squamous cell carcinoma of the head and neck at any of the following sites:

  * Oral cavity
  * Oropharynx
  * Hypopharynx
  * Larynx
* Complete response achieved after treatment with chemoradiotherapy

Exclusion Criteria:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Temozolomide in Association With Topotecan in Refractory or Relapsed Malignant Tumors in Children and Adolescents

Long term survival can now be achieved in 75% of cases of pediatric cancers. However, some types of tumors (ie CNS tumors) or advanced stages (metastatic sarcomas/neuroblastomas) cannot be cured by any treatment. Thus, evaluation of new drugs or combinations are strongly needed. The recommended doses have been defined in children for TMZ (200 mg/m2/d x 5 d) and TPT (1.5 mg/m2/d x 5 d). Some preclinical and clinical studies have shown activity of both drugs in some pediatric cancers. Nevertheless, the association of the two drugs has never been evaluated. The study aims to determine Maximum Tolerated Dose and dose limiting toxicities of each drug when associated and to assess efficacy of the combination.


Eligibility Criteria:
Inclusion Criteria:

* histologically documented malignant tumor
* refractory or relapsing after conventional treatments and for which there is no curative treatment available
* life expectancy \> 8 weeks
* no significant co-morbidity (NCI-CTC \< 2)
* No organ toxicity
* no chemotherapy within the 4 previous weeks, 6 weeks for nitrosurea or radiotherapy

Exclusion Criteria:

* Hypersensibility to Topotecan and/or Temozolomide or to one of their compounds
* Hypersensibility to Dacarbazine (DTIC)
* Galactosaemia, Glucose and galactose malabsorption syndrom, deficiency in lactase
Regional Blood Saturation Levels in Gastroschisis

Gastroschisis is one of the most common neonatal surgical conditions, and is increasing in incidence. Postnatal bowel ischemia leading to necrosis, bowel loss and short-bowel syndrome, occurs in a few instances, with significant impact. Intestinal gangrene occurs in up to 37%. The cause of the gangrene can be multifactorial. Contributing factors can be volvulus; venous engorgement with ensuing arterial compromise; constriction of the gut mesentery at the defect; and contribution of the hydrostatic effect of the column of bowel within a silo.

Theoretically, the increased hydrostatic pressure incurred by the bowel in a preformed silo, may decrease blood flow to the apex of the bowel and contribute to ischemia. However, this does not seem to be the norm, as most cases do well in the silo. Cases of intestinal ischaemia within the silo have been described in patients. Any objective measure of bowel perfusion and therefore viability which can aid clinical assessment and management may benefit patient outcome.

Near-infrared spectroscopy (NIRS) is used to noninvasively measure and monitor changes in the approximate regional haemoglobin oxygen saturation (SO2) in the blood. Measurement of oxygen saturation using NIRS is already in clinical application in other neonatal and paediatric medical and surgical diseases. NIRS has been recommended as a good trend indicator of changes in neonatal tissues oxygenation. NIRS-measured duration of cerebral oxygen desaturation is an accurate predictor of postoperative neurological injury in children undergoing cardiac surgery.

The investigators propose to use NIRS to measure SO2 in the intestinal bed in patients with gastroschisis and to ascertain if there is any clinical advantage to routine monitoring in these patients.

The aim of the study will be to:

1. Measure Gastrointestinal SO2 (GSO2) of the bowel within the silo of gastroschisis patients
2. Identify the clinical progress of patients with gastroschisis in the postnatal period
3. Identify any association of the measured GSO2 with the clinical outcome and any gastrointestinal complications


Eligibility Criteria:
Inclusion Criteria:

* Gastroschisis diagnosed antenatally or at birth

Exclusion Criteria:

* Associated congenital condition affecting respiratory system , cardiovascular system or global development
* Generalised sepsis
Pharmacokinetic Study of Clarithromycin in Very Low Birth Weight (VLBW)

The purpose of this study is to investigate the pharmacokinetics of clarithromycin which is used for premature infants with ureaplasma.


Eligibility Criteria:
Inclusion Criteria:

* birthweight \< 1500gm or GA \< 32 weeks
* transtracheal aspirate/gastric juice ; ureaplasma/mycoplasma(+)

Exclusion Criteria:

* sepsis, hypotension, shock
* major congenital anomaly
Smartphone-based Self-management in COPD Patients: A Needs Assessment Survey

COPD patients often experience multiple symptoms (e.g. dyspnea, cough, and deteriorating quality of life) and have imposed a substantial economic and social burden on health care.

The current proposal is to explore the information needs of COPD patients and to evaluate the feasibility and acceptability of a smartphone-based instant messaging self-management support program to improve the quality of life in patients with COPD.

Chronic obstructive pulmonary disease (COPD) is the number 3 killer globally by 2020. COPD patients often experience multiple symptoms (e.g. dyspnea, cough, and deteriorating quality of life) and have imposed a substantial economic and social burden on health care.

Current policy for the prevention and management of long-term conditions focuses on efforts to prevent the onset or slow progression of disease early in the disease trajectory. This prevention paradigm has only recently been adopted for COPD. Systematic reviews have shown self-management support for patients with COPD is effective in improving health-related quality of life and in reducing hospital admissions, but the evidence comes largely from patients with moderate or severe disease and is predominantly recruited from secondary care. Simple and systematic strategies are needed to improve out-of-hospital support and management for people living with COPD.

An instant messaging smartphone app, which allows texts, audio, pictures and video messages to be shared in chat groups, is already available to and is the most popular in the Hong Kong general public. Mobile instant messaging can be conducted through a daily use device to increase access and efficacy, which has been suggested as a feasible approach to delivering an intervention with positive effects on health behaviours and outcomes. Text messaging via mobile phones has been shown to be effective in helping promote lifestyle change in diabetes self-management, weight loss, physical activity, smoking cessation and medication adherence with quantitative and qualitative evidence. However, we have not found messaging intervention that was applied in people with COPD, except an ongoing study of using instant text message support for patients with chronic respiratory and cardiovascular diseases.

Hence, the current proposal is to use a quantitative survey and qualitative interview exploring the information needs of COPD patients and evaluating the feasibility and acceptability of a smartphone-based instant messaging self-management support program to improve the quality of life in patients with COPD.

Eligibility Criteria:
Inclusion criteria

* Aged 18 years and above
* Diagnosis with COPD
* Able to speak and read Chinese
* Able to complete the self-administered questionnaire
* Mental, cognitive and physically fit determined by the clinician or responsible investigator
* Signed informed consent

Exclusion criteria

* Serious active infection
* Severe respiratory insufficiency
Serum Markers as a Bioassay for Unipolar Depression

The goal of the study is to validate a biomarker assay for unipolar depression based on serum proteins involved in inflammation, metabolism, and stress response. The study will compare patients with a current major depressive episode to individuals with no history of depression. The hypothesis is that the assay can serve as a diagnostic tool that would be more objective than standard diagnostic questionnaires.


Eligibility Criteria:
Inclusion Criteria (Depressed):

* Aged 18 to 60.
* Meets DSM-IV criteria for Unipolar Major Depression, either single or recurrent.
* 21 item Hamilton Depression rating scale score greater than 18.
* Capable of providing informed consent.
* Has an established residence and phone number.

Exclusion Criteria:

* Meets DSM-IV criteria for Bipolar Disorder, Schizophrenia, Schizoaffective disorder or other major Axis I Psychiatric disorders (except for depression and phobia per above).
* Addison's Disease, Cushing's Disease, or other known dysfunction of the HPA-cortisol axis.
* Rheumatoid arthritis, lupus, or other condition associated with increased inflammation.
* Regular use of non-steroidal anti-inflammatory medications, steroids, or other medications know to interact with the inflammatory process of the HPA axis.
* A medical condition or regular use of a mediation, which I the opinion of the investigator is likely to influence the inflammatory or HPA responses.
* Pregnancy.
* Meets DSM-IV criteria for substance abuse or dependence in the last month.
* Regular cigarette smoking.
* History of fainting or other significant adverse event during blood drawing in the past.
Efficacy of Single Injection Femoral Nerve Block With Liposomal Bupivacaine for Total Knee Arthroplasty

The purpose of this study is to compare the quality and duration of pain relief after a total knee replacement provided by a single shot of standard bupivacaine versus a single shot of liposomal bupivacaine, at the site of the femoral nerve. It is hypothesized that the liposomal bupivacaine formulation will provide more effective pain relief than standard bupivacaine.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female, ≥18 years of age
2. Scheduled to undergo primary unilateral TKA under general anesthesia.
3. American Society of Anesthesiology (ASA) Physical Status I-III
4. Able to demonstrate motor function by performing a 20-meter walk, and sensory function by exhibiting sensitivity to cold.
5. Able to provide informed consent, adhere to the study visit schedule, and complete all study assessments.

Exclusion Criteria:

1. Currently pregnant, nursing, or planning to become pregnant during the study or within 1 month after study drug administration.
2. Planned concurrent surgical procedure (e.g., bilateral TKA).
3. Body weight \< 50 kg (110 pounds) or a body mass index ≥ 40 kg/m2.
4. Contraindication to any of the pain-control agents planned for postsurgical use (i.e., morphine, hydromorphone, oxycodone, bupivacaine).
5. Previous participation in a liposome bupivacaine study.
6. History of, suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
7. Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, could interfere with study assessments or compliance.
A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms

This study is being conducted to evaluate the safety, tolerability, and dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered as a monotherapy or in combination with ruxolitinib in participants with myeloproliferative neoplasms.


Eligibility Criteria:
Inclusion Criteria:

* Life expectancy \> 6 months.
* Willingness to undergo a pretreatment and regular on-study BM biopsies and aspirates (as appropriate to disease).
* Existing documentation from a qualified local laboratory of CALR exon-9 mutation.
* Participants with MF and ET as defined in the protocol.

Exclusion Criteria:

* Presence of any hematological malignancy other than ET, PMF, or post-ET MF.
* Active invasive malignancy over the previous 2 years.
* Active HBV/HCV, HIV.
* History of clinically significant or uncontrolled cardiac disease.
* Has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned.
* Laboratory values outside the Protocol-defined ranges.
* Participants undergoing treatment with G-CSF, GM-CSF, or TPO-R agonists at any time within 4 weeks before the first dose of study treatment.
* Prior history of major bleeding, or thrombosis within the last 3 months prior to study enrollment.
* Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody, or hypomethylating agent used to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
* For TGBs only: Undergoing treatment with a potent/strong inhibitor or inducer of CYP 3A4/5 within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment, or expected to receive such treatment during the study.

Other protocol-defined Inclusion/Exclusion Criteria may apply.
Clinical Trial of a Group Self-management Support Program for Anxiety Disorders

Background. Self-management support is a complementary approach to treatment that aims to educate participants on the nature of anxiety and to improve their strategies to manage symptoms and well-being, thus presenting the potential to enhance recovery, improve outcomes, reduce recurrence rates and lower health care costs. There is limited evidence to support the effectiveness of group self-management support for anxiety disorders in community-based care.

Objectives. This study aims at examining the effectiveness of a virtual group self-management support program (SMS) for anxiety disorders as an add-on to treatment-as-usual (TAU) in community-based care settings. We will also assess the incremental cost/effectiveness ratio and the implementability of the intervention.

Methods. The trial is a pragmatic randomized controlled trial with a pre-treatment, post-treatment (4-month post-randomization), and follow-ups at 8, 12 and 24-months. Intervention. The experimental condition will consist of a 10-week SMS program for anxiety disorders in addition to TAU. The control condition will receive TAU without restrictions for anxiety disorders. Inclusion criteria will comprise being 18 years old or older, French-speaking, and presenting symptoms of anxiety disorders based on self-reported validated assessment scales. Patients will be recruited in the province of Quebec (Canada). Outcome measures: The primary outcome measure is the Beck Anxiety Inventory (BAI). The secondary outcome measures include self-reported instruments for anxiety and depressive symptoms, recovery, self-management, quality of life, and service utilisation. Statistical analysis: Intention-to-treat analysis. A mixed effects regression model will be used to account for between and within-subject variations in the analysis of the longitudinal effects of the intervention.

Expected outcomes. The rigorous evaluation of the SMS intervention in the real world will provide information to decision makers, health care managers, clinicians and patients regarding the added value of group SMS for patients with anxiety disorders. Widespread implementation of this intervention could lead to more efficient mental health care services, to better long-term outcomes and to a significant reduction in the extensive social and economic burden of anxiety disorders.


Eligibility Criteria:
Inclusion Criteria:

* (1) aged 18 and over,
* (2) fluent in spoken and written French,
* (3) presence of symptoms of anxiety disorders based on self-reported validated assessment scales and semi-structured assessment interview,
* (4) access to a computer or tablet connected to the internet with microphone and video camera

Exclusion Criteria:

* (1) previous enrolment in the SMS intervention provided by Relief
* (2) active suicidal intentions,
* (3) severe depressive symptoms,
* (4) active substance-related and addictive disorder,
* (5) cognitive impairment
Metabolic Syndrome Criteria and the Effect of Testosterone Treatment in Young Men With Hypogonadism

The study is designed to answer the following questions:

1. Is hypogonadism a cause for the metabolic syndrome ?
2. What is the effect of testosterone replacement on the metabolic parameters ?

This is a retrospective design, which is performed by investigating the registrations of patients with hypogonadotrophic hypogonadism between the years 2002-2009.

Eligibility Criteria:
Inclusion Criteria:

* Men
* Congenital hypogonadism
* Treatment Naive

Exclusion Criteria:

* Previous history of androgen replacement
* Hypertension
* Diabetes mellitus