cyrilzakka/clinical-trials huggingface dataset:
Comparison Airway Devices in Nasotracheal Intubation in Manikin

Nasotracheal intubation is usually required in oral surgery to allow an unrestricted surgical approach. The standard method is generally performed using the Macintosh laryngoscope supported by Magill forceps. However, it is recommended to perform awake tracheal intubation in situations where a difficult airway is predicted, a scenario where this technique may be poorly tolerated by the patient. Although fibreoptic intubation is considered the "gold standard", sometimes it is difficult to perform and,therefore, alternatives are necessary. The hypothesis is that optical laryngoscopes as the Airtraq nasotracheal and Mcgrath can improve the time and/or success of nasotracheal intubation in a manikin.


Eligibility Criteria:
Inclusion Criteria:

* Be Component of service of anesthesiology C.H.U. A Coruña
* Give voluntary consent to participate in the study

Exclusion Criteria:

* Not meet the above criteria
Impact of Drains on Postoperative Nausea and Vomiting After Thyroid Surgery

Wound Drains after Thyroid- and Parathyroid Surgery Impact on Postoperative Nausea and Vomiting (PONV)

Postoperative nausea and vomiting (PONV) is common after thyroid surgery. Many patients describe PONV as more irritant in the postoperative course than the endured pain. Postoperative drains are put after thyroid surgery to early recognize bleeding and to collect wound secretion to avoid pressure on the trachea. Whether wound drains do impact on PONV is not known. Therefore, we tested the impact of wound drains on PONV after thyroid- and parathyroid surgery in a randomized controlled clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years of age
* informed consent
* planed thyroid- or parathyroid resection
* euthyreostatic preoperative condition

Exclusion Criteria:

* younger than 18 years of age
* pregnancy
* no informed consent
* retrosternal struma
* known postoperative nausea and vomiting prior to surgery
* severe and life threatening systemic health issues
Evaluation of Home Treatment for Acute Psychiatric Care

The study's goal is to evaluate whether home treatment is an effective and efficient alternative to inpatient care for people with acute mental illness. Patients who meet the study's inclusion criteria are randomly assigned to either the condition home treatment or inpatient care (treatment-as-usual), during one year. Following two years, the two treatment modalities will be analyzed in terms of inpatient days, cost effectiveness, rehospitalization rate, severity of symptoms and sociodemographics.

The study's goal is to evaluate whether home treatment is an effective and efficient alternative to inpatient care for people with acute mental illness. Therefore, psychiatric patients in need of hospitalization who meet the study's inclusion criteria are randomly assigned to either the condition home treatment or inpatient care (treatment-as-usual) during one year. Home treatment patients are visited by a mobile and multiprofessional care team at their homes. Additionally, patients without a health insurance for home treatment and patients who are directly assigned to home treatment are included in separate study groups. Following two years, it will be checked whether home treatment leads to a reduction of inpatient days as a primary outcome. Further outcomes such as cost effectiveness, rehospitalization rate, severity of symptoms and sociodemographics will be also analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Need for acute psychiatric inpatient care
* Residence in Zurich city
* Health insurance for Home Treatment

Exclusion Criteria:

* none
Vitamin D3 Supplementation in Pediatric IBD: Weely vs Daily Dosing Regimens

The purpose of this prospecitve randomized controlled trial is to compare effectiveness and patient/family adherence of weekly or daily Vitamin D-3 dosing regimens in children with Inflammatory Bowel Disease (IBD) who are 25-hydroxyvitamin D \[25(OH)D\] insufficient or deficient. The primary aim of this pilot study is to evaluate the effectiveness of once weekly verses daily D-3 dosing regimens based on the most current IBD supplementation guidelines in improving 25(OH)D levels. A seconary aim is to determine if there is difference in adherence between dosing regimns.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 5 to 17 years with a diagnosis of Inflammatory Bowel Disease, who have a 25(OH)D level below 30 ng/ml within 2 weeks of enrollment
* Subject/family must be able and willing to take oral medications, complete a 3 day dietary record, and return for 8 week concluding visit or clinicl visit

Exclusion Criteria:

* Subjects will not be eligible if they are intolerant of vitamin supplementation or any ingredients in the chosen supplment, are unable or unwilling to take oral supplements, or are on specific medical therapy for diminished bone mineral density
* Children with parathryoid disease, granulomatous disorders or William's syndrome will also be excluded from the study
Intra Hospital Mortality Risk Factors in Patients Admitted to Cardiac Intensive Care Units in 2017 in France

Retrospective, observational cohort study.

Objectives:

To identify intra hospital mortality risk factors in patients admitted admitted to cardiac intensive care units (CICU). The clinical main endpoint will be the observed percentage of deaths that occured during the year 2017 in french CICU.

To identify the length of stay key determiners of patients admitted in french CICU.

The study will use data from one of the french nationwide healthcare systems database (SNDS) : the national hospital discharge database (PMSI) to be precise.


Eligibility Criteria:
Inclusion criteria:

* Being admitted at least one time in a french CICU in 2017
* Being covered by the mandatory french national health insurance plan in 2017 without discontinuity

Exclusion criteria:

* Being older than 18 years of age
Electrical Acupuncture and Laser Therapy for Low Back Pain

This is a treatment for low back pain using electrical stimulation and laser for 6 weeks.

The purpose of the study is to investigate the effects of electroacupuncture and laser therapy to treat chronic low back pain.

Eligibility Criteria:
Inclusion Criteria:

* Low back pain for over 6 weeks

Exclusion Criteria:

* Individuals with cancer
* Tuberculosis
* Pacemakers
* Pregnancy
* Osteoporosis
* Heart disease
* Kidney failure
* Thyroid disorders
* Diabetes
* Chronic disease
* Neurological diseases
* Skin or bleeding disorders
* Currently taking drugs or medications
* A health history questionnaire will be used to screen subjects
Trial on Safety and Efficacy of Velmanase Alfa Treatment in Pediatric Patients With Alpha-Mannosidosis

The main objectives of the study are to evaluate safety and efficacy of repeated treatment with recombinant human alfa-mannosidase of patients with alfa-mannosidosis aged less than 6 years

The Primary endpoints of the study include:

* Safety and tolerability of velmanase alfa as per Adverse events (AEs, including IRR), vital signs, laboratory parameters (hematology, biochemistry and urinanalysis)
* Detection of anti-velmanase alfa antibodies and neutralizing/inhibitory antibodies

The Secondary endpoints include changes from baseline to 24 months for the following parameters. Efficacy outcomes:

* Serum oligosaccharides
* Functional capacity: Peabody Developmental Motor Scale - 2nd edition (PDMS-2) scores, Mullen's Scale of Early Learning (MSEL) scores, Bruininks-Oseretsky Test Of Motor Proficiency-2nd Edition (BOT-2), when applicable by age (from 4 years) or upon the judgment of the physician
* Endurance: 3-Minute Stair Climb Test (3MSCT) and 6-Minute Walk Test (6MWT) in pediatric patients from 4 years of age, or when applicable according to the judgment of the physician, 2-Minute Walk Test (2MWT) in pediatric patients below 4 years of age, or when applicable according to the judgment of the physician
* Hearing evaluation: Otoacoustic Emissions (OAE) testing, Automatic Auditory Brainstem Response (A-ABR) audiometry
* Immunological profile, when applicable upon the judgment of the physician:
* CSF biomarkers: Tau protein (Tau), Neurofilament Protein Light (NFL), Glial Fibrillary Acidic Protein (GFAp), Oligosaccharides
* Assessment of quality of life via Questionnaire to parents
* Assessment of mannose-rich oligosaccharides in brain tissue, MRI
* Pharmacokinetic parameters

Eligibility Criteria:
Inclusion Criteria:

1. Patient's custodial parent(s) must provide signed ICF prior to the involvement of the patient in any trial-related activities
2. The subject's custodial parent(s) must have the ability to comply with the protocol
3. The subject must have a confirmed diagnosis of alpha-mannosidosis as defined by alpha-mannosidase activity in leukocytes or fibroblasts \< 10% of normal activity (historical data)
4. The subject must have an age at the time of screening \< 6 years.

Exclusion Criteria:

1. The subject's diagnosis cannot be confirmed by alpha-mannosidase activity \< 10% of normal activity
2. Presence of known chromosomal abnormality and syndromes affecting psychomotor development, other than alpha-mannosidosis
3. History of BMT
4. Presence of known clinically significant cardiovascular, hepatic, pulmonary, or renal disease or other medical conditions that, in the opinion of the Investigator, would preclude participation in the trial
5. Any other medical condition or serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the trial
6. Planned major surgery that, in the opinion of the Investigator, would preclude participation in the trial
7. Participation in other interventional trials testing the IMP within the last 3 months.
Long-Term Outcome in Congenital Undescended Testis After Surgical Treatment by Orchidopexy

The purpose of this study is to determine the long-term outcome in congenital undescended testis after surgical treatment by orchidopexy and to what extent orchidopexy is the treatment for congenital undescended testis.


Eligibility Criteria:
Inclusion Criteria:

* The orchidopexy has taken place in the Medical Center Alkmaar between 1986-2004
* The indication concerned a congenital undescended testis
* It concerns a first orchidopexy to the concerning testis

Exclusion Criteria:

* Orchidopexy has taken place on an other reason than congenital undescended testis (for example: torsio testis)
* It concerns re-orchidopexy
Evaluation of Anterior Cruciate Ligament Tears Using Diffusion Tractography

Knees injuries commonly affect the ACL. French current methodology is based on MRI focused on the knee with morphological sequences (T1, DP fat sat) allowing the study of ACL as follows: No lesion / Partial tear / Complete tear.

The treatment (kinesitherapy, surgery, no intervention) is defined taking into account several factors such as age, knee laxity, physical activity and outcome of the radiology analysis (partial or complete tear). However, if the classification is straightforward in case of complete tear, it is not possible to establish a quantitative impact on the ACL in case of partial tear. As a consequence, the investigators will analyze the anisotropy coefficient with diffusion tractography. Any patient who undergo a posttraumatic knee MRI at the CHU Amiens Picardie will have an appointment at the 3T "Signa" MRI that has the knee-centric diffusion tractography sequence.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old,
* Patient referred for non-enhanced knee MRI for traumatism.
* Affiliation to a social security program,

Exclusion Criteria:

* Person under guardianship or curators,
* Any contraindications to MRI
Measuring Sensitivity to Nonignorability

To develop a new statistical index that measures sensitivity to non-ignorability (index of sensitivity to nonignorability, or ISNI) for model-based inferences.

BACKGROUND:

Despite a considerable number of recent developments, missing data and associated methodology continues to be an important topic of research in biostatistics, medicine and public health. As investigators begin to understand the limitations of model-based inferences under the assumption of non-ignorable missingness, recent attention has turned to the formulation and implementation of sensitivity analyses. Having a general-purpose index to assess sensitivity to departures from ignorability would be extremely useful to researchers in a variety of fields in the health sciences. This is especially true if the index is relatively easy to compute and interpret.

DESIGN NARRATIVE:

It would be useful to have a general, easily computed diagnostic that characterizes data sets with respect to their potential for sensitivity to nonignorability. The investigators have developed a diagnostic that measures the effect of small perturbations from ignorability on coefficient estimates in the univariate linear model with missing observations.They will extend their analysis in a number of directions: i) They will develop a general class of diagnostics for Bayes and direct- likelihood inferences, and demonstrate its application to a number of important special cases. ii) They will develop an analogous theory for sensitivity to nonignorability in frequentist estimation and testing. iii) They will develop a general form of the diagnostic for the coarse-date model, a generalization of missing data that includes censoring and rounding as special cases. iv) They will analyze a number of real- world data sets that represent important cases where nonignorability is of interest, including dropout in longitudinal data, censored survival data, and cross-over in clinical trials.

Eligibility Criteria:
No eligibility criteria
Assessment of the Safety, Tolerability and Efficacy of MEDI8968 in Subjects With Moderate to Severe Hidradenitis Suppurativa

The purpose of this study is to gain initial evidence for the safety, tolerability and efficacy of MEDI8968 for the treatment of subjects with moderate to severe hidradenitis suppurativa


Eligibility Criteria:
Inclusion Criteria:

* Hidradenitis suppurativa (HS) (moderate to severe)
* Diagnosis of HS for at least 1 year
* At least 5 active inflammatory lesions in at least 2 locations
* On a stable dose of antibiotics and/or analgesics for at least 4 weeks (if already taking these medications)
* Average pain score of 3-9.

Exclusion Criteria:

* History of cyclic neutropenia
* Laboratory assessment abnormalities
* Underlying disorder considered unsuitable for inclusion
* Other skin diseases that may interfere with HS assessment
* Pregnancy or planning for pregnancy
Study of Pazopanib, Paclitaxel, and Carboplatin in Patients With Advanced Solid Tumors

This is an open label, dose escalation study to determine the safety and tolerability and maximum tolerated dose of pazopanib combined with weekly paclitaxel and carboplatin in patients with advanced solid tumors.

This is an open label, dose escalation study to determine the maximum tolerated dose (MTD) of pazopanib combined with weekly paclitaxel and carboplatin in patients with advanced solid tumors. There will be a dose expansion cohort of thirty patients to assess detailed pharmacokinetics and to assess any signal of activity in patients with solid tumors and in a portion who have breast cancer that is triple negative (ER-negative, PR-negative, and HER2-negative).

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of a solid malignancy with advanced disease that has relapsed, that is refractory to standard therapies, or for which there is not standard therapy, or for which the patient opts not to receive standard therapy.
* At the recommended phase II dose level, triple-negative breast cancer defined as ER-negative, PR-negative, and HER2-negative, will be enrolled and another 10 patients with a solid malignancy who would benefit from a paclitaxel and carboplatin-based regimen, will also be enrolled.
* Male or female ≥ 18 years of age
* Able to swallow and retain oral medications

Exclusion Criteria:

* Major surgery within last 28 days or cytotoxic chemotherapy, biologic therapy, investigational agents, or radiotherapy within last 21 days. Patients who have completed therapy with mitomycin C or nitrosurea will have to wait 42 days.
* More than 3 prior lines of cytotoxic chemotherapy for metastatic disease
Prone Versus Left-sided Colonoscopy in Obese Patients

For obese patients, a randomized trial aimed at determining whether colonoscopy performance and patient comfort is improved if a patient is in the prone position (lay on their abdomen) versus the traditional left-sided position.


Eligibility Criteria:
Inclusion Criteria:

* BMI \>30kg/m2
* Elective Colonoscopy

Exclusion Criteria:

* Patients with prior colonic resection, strictures, or known colonic or intra-abdominal malignancy.
* Patients who are scheduled to have monitored or general anesthesia for their procedure.
* Emergency colonoscopy
* Inadequate preparation of the colon as assessed during colonoscopy
The Effect of Fasudil on Vascular Function in Humans

The purpose of the study is to evaluate how the rho kinase inhibitor, fasudil, affects vascular function in patients with atherosclerosis and hyperlipidemia.


Eligibility Criteria:
Inclusion Criteria:

* Coronary artery disease
* Hyperlipidemia -OR-
* Healthy adults

Exclusion Criteria:

* Unstable angina, myocardial infarction or revascularization within 3 months
* Symptomatic heart failure
* Creatinine \> 3.0 mg/dl
* Liver enzymes \> 3X upper limit of normal
* Chronic hypoxia
* Significant anemia
* Chronic inflammatory disease
* Pregnancy
* Willing to withdraw statins for duration of study
Combination of RAD001 With Carboplatin, Paclitaxel and Bevacizumab in Non-small-cell Lung Cancer (NSCLC) Patients

This 2 step study aims to establish a tolerable dose level and regimen of RAD001 in patients with advanced NCLC not previously treated with systemic therapy. In step 1 of this study, RAD 001 is given in combination with carboplatin and paclitaxel and in Step 2 RAD001 is given in combination with carboplatin, paclitaxel and bevacizumab

This is a two-step, open-label, multi-center, dose escalation Phase 1 study in which RAD001 is administered in combination with carboplatin and paclitaxel (CP) in Step 1 as well as carboplatin, paclitaxel, and bevacizumab (CPB) in Step 2 in patients with advanced (unresectable or metastatic) NSCLC not treated previously with systemic therapy for advanced disease

Eligibility Criteria:
Inclusion criteria:

* Age over 18 years
* Advanced Non Small Cell Lung Cancer (Stage IIIB/IV)
* Ability to perform normal daily functions

Exclusion criteria:

* Chronic steroid treatment
* Prior treatment with chemotherapy for advanced lung cancer
* Prior treatment with mTOR inhibitors
* Active bleeding conditions, skin conditions, gastrointestinal disorders, mouth ulcers, eye conditions, chronic liver or kidney disorders, uncontrolled diabetes, infections or other severe medical conditions
* Known sensitivity to platinum compounds, taxanes or bevacizumab
* Other cancers within the past 5 years
* Pregnant or breastfeeding women Other protocol-defined inclusion/exclusion criteria may apply
Using Online Tools to Increase Weight Loss in Primary Care

The goal of the proposed project is to test the effectiveness of an intervention (Connect4Health Engage) focused on motivating and guiding patients to use empirically supported, freely available online tools for weight loss. A randomized trial will be conducted in primary care clinics. Fifteen to twenty PCPs will be recruited, followed by 453 patients. Patients will complete either the 52-week Connect4Health Engage intervention or Connect4Health Discover, an educational control.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* BMI ≥ 30 kg/m2 based on self-report body weight and height, OR BMI 27-29.9 kg/m2 with a weight related comorbidity of hypertension, type 2 diabetes, pre-diabetes, dyslipidemia, or obstructive sleep apnea, gastroesophageal reflux disease, or coronary artery disease.
* Self-report weight ≤ 375 lbs (the maximum weight that BodyTrace scales can accurately detect is 397 lbs, thus 375 lbs provides a buffer to allow detection of at least 20 lbs weight gain).
* Has valid email address in EHR
* Has an appointment scheduled with enrolled PCP about 30-45 days after IDR query
* Speaks and reads English
* Has either WiFi internet access at home or a phone or tablet with a data plan.

Exclusion Criteria:

* BMI≥ 45 kg/m2.
* Currently enrolled in structured weight loss treatment
* In past month, has been actively participating in a weight loss focused online community (i.e., posting or reading content).
* Currently tracking food intake 3 days per week
* Pregnant or planning to become pregnant in the next 6 months
* Currently breastfeeding (or pumping breastmilk) 3 times per day or more.
* Currently undergoing treatment for cancer or has active cancer
* Had cardiovascular event in the past 60 days
* Inpatient psychiatric treatment in the past 6 months
* Eating disorder in past 5 years
* Congestive heart failure resulting in recent (past 6 months) hospitalization or contributing to difficulty breathing or difficulty doing daily activities.
* Dementia diagnosis
* Bariatric surgery in the past year or currently undergoing evaluation for bariatric surgery
* Type 1 Diabetes
* Currently taking prescription medication for weight loss
* Inability to stand on body weight scale independently
* Impaired hearing
* Unable to read content on websites without assistance
* Planning to move out of the region in the next 12 months.