cyrilzakka/clinical-trials huggingface dataset:
Is Routine Postoperative Oxygen Therapy Still Necessary in 2020?

The purpose of this study by automated control of oxygen supply in the immediate postoperative period is to show the possibility of immediate weaning in the postoperative period in case of remifentanil use and complete reversion of curarization.

The main hypothesis of this study is that classical oxygen therapy at 3l/min is futile in the postoperative period of a so-called modern anaesthesia and that a total weaning within one hour after arrival in the ICU is possible whatever the postoperative position of the patient. The aim is therefore to include patients who have to undergo a scheduled surgery under anaesthetic sedation (analgesia with remifentanil) or general anaesthesia (combining remifentanil, propofol rocuronium) for ambulatory surgery. The trial is interventional, randomized, monocentric to demonstrate the absence of interest of prolonged postoperative oxygen therapy under specific intraoperative conditions.

Eligibility Criteria:
Inclusion Criteria:

* Patients managed by the Anesthesia Department of the Foch Hospital;
* Anesthetic sedation (analgesia with remifentanil) or general anesthesia (combining remifentanil, propofol and possibly rocuronium);
* Men or women over 18 and under 80 years of age;
* To benefit from a surgical intervention scheduled \> 48 hours in relation to the procedure;
* Scheduled outpatient surgery;
* Have signed a consent form;
* Be affiliated to a health insurance plan.

Exclusion Criteria:

* Pregnant or nursing patients;
* Oxygen dependent preoperatively or at risk of oxygen dependence postoperatively;
* Lung resection surgery;
* Brain surgery (intracerebral neurosurgery); ENT surgery requiring a half-seated position after the operation;
* Being deprived of liberty or under guardianship.
Treatment of Acyclovir-Resistant Mucocutaneous Herpes Simplex Disease in Patients With AIDS: Open Label Pilot Study of Topical Trifluridine

To determine the safety, effectiveness, and toxicity of topical (local) trifluridine in treating mucocutaneous (at the nasal, oral, vaginal, and anal openings) Herpes simplex virus ( HSV ) disease that has shown resistance to acyclovir in HIV-infected patients. HSV infection in patients with AIDS is often associated with skin sores and frequent recurrences. Treatment with the drug acyclovir results in healing for most patients, but repeated treatment sometimes results in resistance of the virus to acyclovir. Thus, when this happens, other treatments need to be used. Trifluridine is an antiviral drug that is used for the treatment of Herpes infections that occur in the eye. This study attempts to determine if trifluridine is useful for treating HSV sores that have not healed after treatment with acyclovir.

HSV infection in patients with AIDS is often associated with skin sores and frequent recurrences. Treatment with the drug acyclovir results in healing for most patients, but repeated treatment sometimes results in resistance of the virus to acyclovir. Thus, when this happens, other treatments need to be used. Trifluridine is an antiviral drug that is used for the treatment of Herpes infections that occur in the eye. This study attempts to determine if trifluridine is useful for treating HSV sores that have not healed after treatment with acyclovir.

Patients receive at least 10 days (and up to 42 days) of treatment with topical trifluridine. Trifluridine is applied in a thin fluid layer that overlaps the edges of the lesion. Polymyxin B sulfate/bacitracin zinc ointment is then applied over the trifluridine. Lesions are covered by a nonabsorbent dressing. Medication is applied every 8 hours.

Eligibility Criteria:
Inclusion Criteria

Concurrent Medication: Included:

* All medications deemed essential for best patient care, including zidovudine (AZT), Pneumocystis carinii pneumonia (PCP) prophylaxis, and acute or maintenance therapies for other opportunistic infections.

Patients must have the following:

* HIV infection or diagnosis of AIDS.
* Mucocutaneous Herpes simplex virus infection.
* Ability to give informed consent.

Allowed:

* Patients may be co-enrolled in other ACTG studies except for those in which treatments are expected to generate neutropenia. Subjects aged 13 - 17 may be enrolled with appropriate consent from parent or guardian.

Exclusion Criteria

Concurrent Medication:

Excluded:

* Acyclovir, ganciclovir, foscarnet, vidarabine or other investigational drugs with potential anti-Herpes simplex virus activity.

Patients with the following are excluded:

* Previous hypersensitivity reaction to trifluridine, polymyxin B or bacitracin.

Prior Medication:

Excluded:

* Immunomodulators, lymphocyte replacement therapy or biologic response modifiers within 14 days prior to study entry.
The Effect of Different Videolaryngoscopes on Intubation Success in Obese Patients

Obese patients may have difficulty in airway management.Patients who have body mass index \> 35 are challenging patients for anesthesiologist. Short neck, more adipose tissue may be reasons for airway difficulty. Videolaryngoscopes are devices that ease the management of difficult airway.This study is designed to evaluate the differences and the effects of different laryngoscopes.


Eligibility Criteria:
Inclusion Criteria:

* body mass index\> 35

Exclusion Criteria:

* emergency airway
ST2 for the Management of Heart Failure - STADE-HF

Heart failure (HF) is a severe disease, burdened with a poor prognosis (30% mortality at 2 years, 30% of rehospitalization within 1 month). It is also a major cause of health burden representing between 1.5 and 2 billions euros per year in France. Approximately 75% of these costs are due to hospitalization.

Besides physical examination and echocardiography, biology may help refine the diagnosis, but also could provide powerful prognostic parameters.

This study aims to assess the value of ST2 in the management of patients admitted for HF to reduce readmission at one month.

Background and rationale:

Heart failure (HF) is a severe disease, burdened with a poor prognosis (30% mortality at 2 years, 30% of rehospitalization within 1 month). It is also a major cause of health burden representing between 1.5 and 2 billions euros per year in France. Approximately 75% of these costs are due to hospitalization.

Besides physical examination and echocardiography, biology may help refine the diagnosis, but also could provide powerful prognostic parameters. The natriuretic peptides are already available and widely used to this purpose. Other biomarkers such as fibrosis markers are promising. In a recently published preliminary work of a cohort of 180 cardiac patients, ST2 is proving to be a powerful prognostic biomarker.

This study aims to assess the value of ST2 in the management of patients admitted for HF to reduce readmission at one month.

Primary and secondary endpoints:

Primary endpoint:

- Interest of ST2 to decrease rehospitalization at one month in patients admitted for HF in the cardiology department and / or Internal Medicine.

Secondary objective:

* economic evaluation
* Clinical Target: mortality, stay at hospital duration
* Impact on biological markers of HF, renal function Population: Any adult being hospitalized for any type of HF. A total of 300 patients will be over a period of 36 months, divided into 2 arms.

Methods: interventional, randomized, opened: the two strategies "ST2 available" versus "ST2 not available" will be compared The duration of patient participation is 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure hospitalization

Exclusion Criteria:

* Other study
* Pregnancy, feeding
* Refusal
* Not possible to perform information
Adaptive Radiotherapy Using Plan Selection for Bladder Cancer

This protocol describes a Phase 2 clinical trial of online adaptive Radiotherapy, using a library of 3 dose plans corresponding to Small, Medium and Large size bladder. The procedure includes 'Common Toxicity Criteria for Adverse Effects'(CTCAE) for registration of adverse effects (baseline, every 2'nd week during RT, 2 weeks, 3, 6, 12 and 24 month after RT) as well as cineMR for intra-fractional motion (baseline and every week during RT). Patients receive standard non-adaptive RT in the first week. Delineations of the bladder on the Cone-Beam scans (CBCT) from first week of treatment are used for planning the Small and Medium size bladder plans. Large size plan are the standard non-adaptive treatment plan used for the first week of treatment. A margin of 5 mm for intra fractional movement is used.

After inclusion patients are asked about their adverse effects by an oncologist using CTCAE (version 4.0) questionnaire. A planning CT-scan is acquired and for the first 10 patients also a MR-scan for intra fractional motion is acquired. The MR sequence is repeated every week during radiotherapy. The first week of treatment a standard non-adaptive IMRT-plan is used and CBCT-scans are acquired before and after treatment. The CBCT-scans are used for delineation of the bladder on the CBCT-scans from the first 4 fractions. The adaptive plans are generated from the union of the first 4 CBCT-bladders and the planning CT bladder (medium size) and the volume contained in at least 2 out of the 5 bladder volumes (small size). Details can be found in the reference list. From the 6'Th fraction the treatment is performed using the most appropriate size of treatment plan. CTCAE is repeated every other week during radiotherapy and 2 weeks, 3, 6, 12 and 24 month after radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven bladder cancer
* Age over 18 years
* Urothelial or planocellular carcinoma
* Stage T2 T4A
* Stage N0M0
* Suitable for radiotherapy
* ECOG/WHO performance status 0-2

Exclusion Criteria:

* Suspected or confirmed distant metastases
* Previous surgery in the small pelvis
* Inflammatory bowel disease
Substance Misuse To Psychiatric Disorders for Cannabis

With the recent availability of vortioxetine, and the surging phenomenon of cannabis misuses amongst young abusers, it is a timely opportunity to conduct an early pharmacotherapy intervention study to offer an evidence-based strategy aiming to stop individuals with cannabis use disorders with depressive or anxiety symptoms, to develop into a more chronic disabling dependence or co-morbid state.


Eligibility Criteria:
Inclusion Criteria:

• Cannabis use disorder with anxiety or depressive symptoms or disorders; or positive cannabis test results in 1 month with anxiety or depressive symptoms

Exclusion Criteria:

* Age \<16 years old
* Unable to read English or Chinese
* Unable to give informed consent
* Had been diagnosed to have Intellectual Disabilities (DSM-5) or Mental Retardation
* Had history of primary psychotic episode
* Had been diagnosed to have substance-induced mood disorder, other than cannabis
* Had been diagnosed to have mood disorders or anxiety disorders
* Had been taking maintenance therapeutic dose of antidepressant continuously \>= 6 months AND with depressive symptom or anxiety symptom being in remission
* Had known hypersensitivity to vortioxetine
* Had known history of serotonin syndrome
* Pregnant
* Mother currently breast-feeding
* Currently taking warfarin and/or having poorly controlled bleeding disorder
* Had history of prolonged QTc ≥500ms and/or known unstable or untreated cardiology disease
A Long-term Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

The objective of this study is to assess the long-term safety of Olumacostat Glasaretil gel, 5.0% in patients with acne vulgaris


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent or assent (for subjects under legal adult age)
* Completed Week 12 visit of either DRM01B-ACN03 or DRM01B-ACN04 studies.
* Willing to comply with the protocol. Subjects under legal adult age will be assessed by the investigator as to their ability to comply with the protocol
* Willing to refrain from using any treatments on the face for acne vulgaris, other than the investigational product, including topical or systemic antibiotics.

Exclusion Criteria:

* Abnormal clinically significant findings on physical exam, vital signs or ECG at Week 12 visit of either the DRM01-ACN03 or DMR01-ACN04 studies that would make further treatment with Olumacostat Glasaretil Gel contraindicated, as determined by the Investigator
* Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study
Double Foley Catheter For Cervical Ripening

To compare the efficacy of three mechanical devices for pre-induction of labour cervical ripening: the Single Foley Catheter, Double Foley Catheter (a new handmade device) and Cook cervical ripening balloon.

This prospective study Scheduled included 74 Double Foley Catheter, 74 Single Foley catheter group and 74 Cook cervical ripening catheter group. All pregnant women will be randomly allocated into three groups: the single Foley, Double Foley Catheter or Cook balloon catheter. Removal of the catheters is planned approximately 12 h after insertion if spontaneous expulsion occurred. The main outcome measures include changes in Bishop score, insertion to delivery time, mode of delivery and occurrence of adverse effects.

Double Foley Catheter is a new method for cervical ripening that Two 18-Fr Foley catheters are connected with sterile suture from the hole end and where the balloons borders end. Both catheters are pushed above the internal cervical os the uterus. One of 18-Fr Foley catheter full with 80 mL of normal saline. The other Foley catheter is pulled into the vagina by applying traction and full with 80 mL of normal saline. The cervix between two balloons of Foley catheters exposed to pressure from both sides from the Foley catheter's balloon's similar to Cook balloon.

Eligibility Criteria:
Inclusion Criteria:

* Women with term pregnancy,

Exclusion Criteria:

* Breech presentations, previous cesarean section, Cephalopelvic disproportion, previous uterine scars, estimated fetal weight above 4500
Laughter Yoga on Pain and Comfort in Individuals Diagnosed With Migraine

In individuals diagnosed with migraine, laughter yoga will be performed for 45 minutes, 3 times a week for 1 month. the other application group will watch funny videos for 45 minutes, 3 times a week for 1 month.


Eligibility Criteria:
Inclusion Criteria:

* Being older than 18 years of age
* Having been diagnosed with migraine for at least one year
* Having no mental disability

Exclusion Criteria:

* individuals using pain relievers
* individuals who have done laughter yoga before
Camp SMART Speech to Print Summer Literacy Camp

This project aims to explore the feasibility and efficacy of a 6-week, intensive summer literacy intervention provided to children in 1st-3rd grades.

1. Purpose/objective:

   To determine the feasibility and preliminary effectiveness of a 6-week literacy summer camp for improving language and literacy outcomes of children with identified language or literacy difficulties.
2. Methods:

   This intervention will be provided by students in the speech and hearing clinic on SDSU's campus. The summer clinical sessions last for 8 weeks. Week 1 will be used for the pre-testing of each participant's baseline language (morphological awareness, phonological awareness, morphosyntax, vocabulary, and narrative language skills) and reading (letter knowledge, nonword reading, reading fluency and reading comprehension). In weeks 2-7, the intervention will take place. This will consist of 3, 3-hour sessions per week. Finally, in week 8, the investigators will conduct post-testing of children's language and reading skills.
3. Subjects:

   The investigators will recruit a maximum of 12 students who are in the summer after Kindergarten, first, or second grade. The investigators will be recruiting students from the local community who either a) have IEPs with eligibility of SLI or SLD-reading or b) have documented parent or teacher concern for reading and/or language skills as determined by parent questionnaire.
4. Planned analyses:

Planned analyses will include analysis of improvement in each of the language and reading skills from pre-test to post-test. The investigators will also include probes of performance of reading skills to allow for single subject analysis. The investigators will develop fidelity rubrics to explore the fidelity of intervention implementation and will analyze how fidelity relates to individual-child-level improvement.

Eligibility Criteria:
Inclusion Criteria:

* Students who are in the summer after Kindergarten, first, or second grade.
* Students from the local community who either a) have IEPs with eligibility of SLI or SLD-reading or b) have documented parent or teacher concern for reading and/or language skills as determined by parent questionnaire.
* Children who fit the above criteria will additionally be determined eligible for the intervention based on language or reading composite skills one or more standard deviations below the mean on the Test of Integrated Language and Literacy Skills (TILLS).
* Children who are rising 4th, 5th, or 6th graders and who have an IEP with eligibility of SLI or SLD-Reading and who demonstrate composite scores one or more standard deviations below the mean on the TILLS may be considered if space remains after recruitment of 1st-3rd graders.

Exclusion Criteria:

* Students who do not either a) have an IEP or b) have documented parent or teacher concern based on parent questionnaire.
* Students who score within the typical range on the TILLS.
* Students who are deaf or blind.
Willingness to Pay for Patient-centred Care

The purpose of this study is to evaluate the monetary value of patient-centrednes in health care by determining a willingness-to-pay for more patient-centredness care for both patients and health insurers

We perform our study in the area of fertility care, as it is known that infertile patients suffer from a high physical and physiological burden during treatment and could especially benefit from patient-centred care. Moreover, previous studies have clearly identified the concept of patient-centred fertility care and have shown that improvement is needed.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing MAR-treatment (ovulation induction, intra-uterine inseminations, in vitro fertilization, or intra-cytoplasmic sperm injection)
* All healthcare purchasers working at one of the 5 large Dutch health insurer companies.

Exclusion Criteria:

* None
Postoperative Anxiety and Depression Among Older Chinese Patients

A multicenter, prospective observational study to describe the socioeconomic characteristics and the occurrence of postoperative anxiety and depression in the Chinese old population.

As China's population ages, the proportion of elderly people undergoing surgery increases. Perioperative anxiety and depression, particularly in elderly patients, is common and associated with multiple medical and social adversities. Previous studies have found a 31 percent risk of anxiety and 29 percent risk of depression in older perioperative patients. However, nationally representative epidemiological data for postoperative anxiety and depression, in particular elderly patients undergoing non-cardiac surgery, are unavailable in China. Therefore, providing nationwide epidemiological data on postoperative anxiety and depression in Chinese elderly patients provides a valuable opportunity for policy makers and health care professionals to optimize the management of geriatric mental health in China.

Eligibility Criteria:
Inclusion Criteria:

1. elderly patients (age ≥ 65 years)
2. undergoing elective surgery with a planned overnight hospital stay following surgery
3. non-cardiac surgery, non-neurosurgical surgery

Exclusion Criteria:

1. patients fully refused to participate in the study
2. patients with severe dementia, language disorder, severe hearing or visual impairment, coma, and end-stage status
3. patients whose surgeries were canceled
4. history of previous severe mental illness or long-term use of psychotropic medications
5. patients admitted to ICU immediately after surgery
6. patients who died within 7 days after surgery
7. patients who did not complete the scale assessment
CPRIT: Patient Adherence to Lung Cancer Screening

To understand participants' barriers to lung cancer screening and their experience with scheduling lung cancer screening.

Primary Objectives/Aims

1. Determine rates of lung cancer scheduling and screening at the UTMB and UT Tyler LCS programs.
2. Using state-of-the-art machine learning (ML) approaches, develop prediction models for adherence to screening guidelines for newly eligible and established patients. Investigators will leverage data from BRFSS, UT Tyler and UTMB to develop and validate the prediction model, ensuring its generalizability and accuracy.
3. Survey participants in the LCS programs about their impressions and experience with the scheduling and completing screening; conduct interviews with participants who receive an order for LCS but do not complete screening by their due date.
4. Interview LCS program directors and staff about barriers and facilitators of increasing screening rates in their programs.

Eligibility Criteria:
Inclusion Criteria:

* Current smoker or quit within the past 15 years
* A 20+ pack-year smoking history
* Healthy enough for treatment

Exclusion Criteria:

* Not applicable as our focus is on patients with an order for screening at the UTMB or UT Tyler
Post Market Observational, Prospective, Multi-center Study

This registry is a post market observational, prospective, multi-center registry.

It is designed to evaluate patient experience with the endobronchial coil system for the relief of the emphysema symptoms and the continued collection of safety and effectiveness data on this CE Mark product.


Eligibility Criteria:
Inclusion and exclusion criteria in the Registry are based on CE Mark approved indication and approved Instructions for Use. Patients enrolled and treated in the Registry study should meet the requirements of the PneumRx Endobronchial Coil System Instructions for Use.
Infrahepatic Inferior Vena Cava Clamping During Hepatectomy

Intraoperative blood loss is a major concern during hepatic resection, as it has been shown to adversely affect patients' perioperative outcome. Reduction of central venous pressure during parenchymal transection has been shown to effectively lower liver hemorrhage. While CVP reduction is mainly achieved via fluid restriction and diuretics, dehydration may impair organ function. Moreover, it may lead to hemodynamic instability, particularly in case of severe bleeding. For this reason the technique of infrahepatic inferior vena cava clamping has been suggested which is able to lower CVP without the need for fluid restriction.

In the present study the two strategies to reduce CVP and by this intraoperative bleeding, namely fluid restriction and inferior vena cava clamping are compared with intraoperative blood loss as primary endpoint.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years
* Scheduled for elective hepatic resection due to any reason
* American Society of Anesthesiologists (ASA) score I to III
* Written informed consent

Exclusion Criteria:

* Medical conditions exposing patient at increased risk for not tolerating liver resection:
* Cirrhosis (Child-Pugh B and C)
* (Hereditary) coagulopathy
* Medical conditions exposing patient at increased risk for not tolerating this trial's study interventions:
* Severe heart disease (e.g. severe CAD requiring intervention, NYHA IV)
* Pulmonary hypertension
* Renal insufficiency (serum creatinin \>2mg/dl or \>177µmol/l; conversion factor 88.4 or requiring dialysis)
* Severe hypernatremia (serum sodium \>155mmol/l)
* Severe hyperchloremia
* For female subjects: pregnancy and lactation
* Impaired mental state or language problems
* Participation in other clinical trials or observation period of competing trials interfering with the endpoints of this trial
* Former participation in the clinical trial
* Expected lack of compliance