cyrilzakka/clinical-trials huggingface dataset:
Observing Changes in Ventilation Pattern During Procedural Sedation

The ventilation (respiratory rate, tidal volume and end-tidal CO2) was monitored for patients receiving procedural sedation during endoscopy procedures in order to observe what changes commonly occur.

The literature does not currently describe which ventilation changes a clinician should watch for to keep a patient safe during procedural sedation provided by fentanyl and propofol. This observational study aimed to record the breath-by-breath respiratory rate, tidal volume and end-tidal CO2 for each patient during procedural sedation for each endoscopy procedure. Data analysis offline will aim to identify any patterns in ventilation which may precede apnea or blood oxygen desaturation. The patterns in ventilation preceding apnea or blood oxygen saturation will be compared and contrasted with the patterns of ventilation during normal ventilation periods.

Eligibility Criteria:
Inclusion Criteria:

* (i) ASA I, II, or III
* (ii) patients older than eighteen
* (iii) English speaking
* (iv) undergoing a colonoscopy procedure and receiving procedural sedation

Exclusion Criteria:

* (i) inability/refusal of subject to provide informed consent
* (ii) standard colonoscopy exclusion criteria used at the GI lab at the University of Utah
* (iii) patients with severe medical conditions that in the view of the acting physician prohibits participation in the study
Pulmonary Artery Doppler in Preeclamptic Mothers

Evaluation of Pulmonary artery Doppler parameters in fetuses of mothers with severe preeclampsia

Preclampsia (PE) represent a major concern in public health, affecting 2-8% of all pregnancies and considered one of the leading causes of perinatal morbidity and mortality. fetal growth restriction (FGR) ia also a common health problem affecting about 5-10% of all pregnancies and commonly associates with preeclampsia . It is estimated that 20% of cases of PE present with FGR and about 50% of early-onset FGR cases will eventually coexist with PE.

Preeclampsia affects about 5% of pregnancies and hypertensive disorders of pregnancy cause over 60,000 maternal fatalities each year around the world .The decision to deliver a woman with severe pre-eclampsia that is far from the term \[mid-trimester\] is difficult for the obstetrician.In most cases of highly premature pre-eclamptic gestation, certain institutions propose continuing pregnancy until one of the following occurs development of fetal lung maturity, development of fetal or maternal discomfort, or accomplishment of gestational age of 34 to 36-week of gestation .

Numerous tests have been developed in an attempt to identify if fetal lung maturation has reached a level sufficient to prevent the development of fetal RDS. These tests are based on four core themes: biochemical testing for active surfactant components, biophysical testing for surfactant functionality, physical testing of amniotic fluid opacity, and ultrasound examination of the fetuses and their tissues . Neonatal RDS has been predicted using fetal pulmonary artery Doppler. Kim and colleagues discovered that a high PAT/ET was linked to newborn RDS .The development of RDS in preterm newborns is linked to an increased acceleration time to ejection time \[AT/ET\] ratio in the fetal pulmonary artery .

Eligibility Criteria:
Inclusion Criteria:

* preeclampsia patients Pregnant 28 -37 weeks

Exclusion Criteria:

* fetal death Congenital fetal anomalies Fetal Cardiac arrhythmia
Intravenous Cannulation In Children During Sevoflurane Induction

The early placement of an intravenous (iv) line in children anesthetized with halothane has been shown safe and acceptable compared with later placement. However, there's not well known with sevoflurane use (2). The aim of the investigator's study is to determine whether one should make iv attempts during the early induction period (at 60seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane inhalation anesthesia

the investigators conducted a prospective randomized study, after obtaining Institutional review board approval, which didn't require written parental consent. Children age 1-12 years, undergoing elective general anesthesia via an inhalation induction were randomized to one of three groups of 30 patients each one, for iv placement, either 60s (group E), 90 or 120 s (group L) following loss of lid reflex. Movement on iv placement and incidence of laryngospasm were determined. Difficulty with iv placement was also recorded. Statistical analysis included contingency testing, ANOVA, and non parametric testing. A P-value \<0.05 was considered significant.

Eligibility Criteria:
Inclusion Criteria:

* ASA I, II
* Age from 1 to 12 years old
* Ambulatory surgery under general anesthesia.

Exclusion Criteria:

* Age \<1 year or\> 12 years
* non-ambulatory surgery,
* contraindication for induction with sevoflurane
Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer

Tissue Expander/Implant Reconstruction: The purpose of this study is to determine how and when nerve sensation to the breast skin returns after mastectomy.

Autologous Tissue Reconstruction: The purpose of this study is to determine whether the tissue being used to reconstruct your breast can provide sensation by using your own nerves. Typically all sensation is lost immediately after this type of surgery and returns to varying degrees. We are hoping to demonstrate that by connecting the two nerves (one from abdomen and one from the chest wall) together, we can attain meaningful sensation in the transferred tissues thereby improving your quality of life following surgery.

To determine the timing and distribution of sensation recovery of breast after mastectomy and breast reconstruction, both with autologous and implant-based reconstruction. Also, to determine the role of innervated free tissue transfer in breast reconstruction.

Specific Aims

1. Determine the timing and degree of return of breast in women who underwent mastectomy with autologous tissue or with implant based reconstruction.
2. Determine sensation following neurotized free flap reconstruction
3. Determine whether neurotization has an impact on quality of life measures post operatively

Study Design Patients will be enrolled prospectively in this data collection study in which they will receive the standard of care for breast cancer resection and oncologically safe and accepted means of breast reconstruction with tissue expander and/or prosthetic implants. Patients will receive additional, non-invasive sensory testing, performed at standard follow up intervals in clinic by their reconstructive team. All patients participating in the study will be consented for enrollment at the pre-operative visit by either the surgeon or physician assistant. As this is a prospective study, all women fitting inclusion criteria over a 6-month minimal, but projected goal 12-month period will be included.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing unilateral or bilateral skin sparing mastectomy for breast cancer
* Patient must have one of the following reconstructions in planned:

  * Immediate tissue expander placement
  * Immediate implant placement
  * Immediate autologous breast reconstruction
* All patients participating in the study must be willing to be consented for enrollment at the pre-operative visit.

Exclusion Criteria:

* Pre-operative radiation therapy
* Any pre-excising
* Patients with absent or prior damaged nipple areola-complex (NAC) on the "non-surgical breast"
TRIM: Danish Form and Dose Study on Vitamin B12

The study investigates the absorption of different doses of hydroxocobalamin and cyanocobalamin in a vitamin B12-replete Danish population.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old

Exclusion Criteria:

* Use of vitamin pills with vitamin B12 within the last two weeks of the study
* Treatment with vitamin B12 injections within the last year
* Known chronic systemic disease
* Not able to give informed consent.
Quality Assessment of Orotracheal Intubation Without Neuromuscular Blocking Agents in Obese Patients

This study will assess the condition of orotracheal intubation in obese patients undergoing an elective bariatric surgery without the use of neuromuscular blocking agents.

During the induction of general anesthesia, Propofol - Remifentanil combination will be used.

The patients will be randomized in 2 groups with different doses of Remifentanil.

The prevalence of obesity increases steadily. For anesthesiologists, the airway management of obese patients is known to be difficult and at risk. Tracheal intubation needs to be successful quickly. Neuromuscular blocking agents allow this option but with a risk of anaphylaxis and respiratory complications. In fact, for many surgical procedures those drugs are not necessary.

Numerous studies in non-obese patients with the combination of Remifentanil and Propofol have shown adequate conditions for tracheal intubation without neuromuscular blocking drugs. This combination has never been studied in obese patient.

After randomization, induction of general anesthesia will be performed with 2,5 mg/kg of Propofol in association with either 3 µg/kg of Ideal Body Weight of Remifentanil, or 3 µg/kg + 30% of Ideal Body Weight of Remifentanil.

Minutes after the induction, orotracheal intubation will be performed, and the Intubation Difficulty Scale recorded.

Other data on hemodynamic, respiratory and airway management will be are collected during the surgery.

In the Post Anaesthetic Care Unit (PACU),Any symptoms of traumatic airway management or aspiration are collected.

Those data will be again looked for and collected on the day of the patient's discharge.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 and under 60 years old.
* ASA score ≤ 3
* Elective bariatric surgery for patient with BMI between 35 and 60 or elective revision of a bariatric surgery for patient with a BMI over 30.
* Patient with a written consent obtained with accurate information.

Exclusion Criteria:

* Patient with risk of aspiration
* Difficult airway known (Cormack score 3 ou 4).
* Opioids addiction.
* Alcoholism
* Chronic use of Opioids
* Confirmed Allergy to Propofol or Remifentanil
* Severe chronic hepatic, kidney or respiratory failure
* Patient already enrolled in another clinical study interfering with this study.
Safety and Feasibility of Dasatinib and Quercetin in Adults at Risk for Alzheimer's Disease

The purpose of this pilot study is to demonstrate the safety and feasibility of administering intermittent doses of Dasatinib and Quercetin (D+Q) in older adults at risk of Alzheimer's disease (AD). The study will evaluate whether giving D+Q may improve cerebral blood flow regulation, mobility, and cognition in older adults, and thus may prevent progression to Alzheimer's disease.

The investigators will conduct a 12-week single arm, open label, pre-post pilot study in 12 adults aged 65 or older with slow gait speed (\<1.0 m/sec) and Mild Cognitive Impairment (MCI, defined as a Telephone Montreal Cognitive Assessment Score (MoCA) \<19). Participants will be asked to take 100mg of Dasatinib and 1,250mg of Quercetin for 2 consecutive days, every two weeks over a period of 12 weeks (12 doses in total, given over 6 cycles).

At baseline, enrolled participants will undergo gait speed and neurocognitive testing, and provide blood and urine to evaluate biomarkers of senescence. At visits 3,4, 6, and 7, participants will have safety labs drawn, and the study team will assess medication adherence and adverse events. At visits 2, 5, and 8, participants will undergo cognitive assessments, gait speed testing, cerebral blood flow and neurovascular coupling testing. At the final study visit, participants will again provide blood and urine to assess biomarkers of senescence.

Eligibility Criteria:
Inclusion Criteria:

* Men and women \>/= 65 years
* Ambulatory,
* Community dwelling,
* Slow gait speed (\<1 m/second),
* Mild Cognitive Impairment (Telephone MoCA score \<21, which is indicative of cognitive impairment)

Exclusion Criteria, or as per clinical judgment:

* Telephone MoCA score \<10 points
* Unwilling to take study medications or follow study protocol
* Inability to independently perform Katz Activities of Daily Living (ADLs),
* Allergies to Dasatinib or Quercetin,
* Hospitalization within 6 months,
* Unstable coronary artery disease (myocardial infarction within 6 months or angina),
* Stroke or transient ischemic attack in the past 6 months,
* Chronic heart failure,
* Current or chronic history of liver disease,
* Neurodegenerative disease including Parkinson's disease,
* Anemia,
* Chronic renal disease,
* Drug or alcohol abuse in the last 5 years,
* QTc prolongation,
* Thrombocytopenia,
* Neutropenia,
* Prolonged prothrombin time or INR,
* Indications of current fluid retention,
* History or current diagnosis of pulmonary hypertension,
* Inability to insonate the middle cerebral artery through a temporal bone window on at least one side using transcranial Doppler ultrasound, or
* Chronic use of any of the following medications: anti-arrhythmic medications, antipsychotics, anxiolytics, anti-platelet or anti-coagulant medications other than aspirin, quinolone antibiotics, or drugs metabolized by the same liver enzymes as Quercetin or Dasatinib.
Regional Anesthesia and Analgesia Techniques in Obese Patients

Obesity is a health problem throughout the world and has increasingly become a widespread epidemic all over the world and also in Turkey. Anesthesia management of obese patients is challenging because of difficult airway, increased drug doses, co-morbidities, loss of anatomical landmarks and difficulties in positioning.

Neuroaxial and peripheral nerve blocks are widely used in anesthesia practice in both obese and non-obese patients undergoing different surgical operations.

In this prospective observational study, the investigators plan to enroll all patients that are applied neuroaxial or peripheral blocks during the study period. The aim of this study is to compare the differences and difficulties of regional anesthesia/analgesia techniques in obese and non-obese patients.

Obesity is a health problem throughout the world and has increasingly become a widespread epidemic all over the world and also in Turkey. Anesthesia management of obese patients is challenging because of difficult airway, increased drug doses, co-morbidities, loss of anatomical landmarks and difficulties in positioning.

On the other hand, neuroaxial and peripheral nerve blocks are widely used in anesthesia practice in both obese and non-obese patients undergoing different surgical operations.

In this prospective observational study, the investigators plan to enroll all patients that are applied neuroaxial or peripheral blocks during the study period. The difficulty of block performance, its relationship with experience, the requirement of changing hands with more experienced clinician, the requirement of changing patient position, regional anesthesia approach or needle (size and length), the requirement of adding rescue block, block success, performance duration, the number of needle direction (multiple attempts), the requirement of changing anesthesia or analgesia technique (conversion to general anesthesia), the requirement of adding another block monitorisation technique, adverse effect/complication, patient satisfaction and patient's request for a similar technique next time are all recorded both in obese and non-obese patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for regional anesthesia/analgesia
* \> 18 years old
* ASA 1-3

Exclusion Criteria:

* \< 18 years old
* Patient refusal for regional anesthesia/analgesia
* Patient refusal to participate in the study
* Allergic to local anesthetics
* Psychiatric diseases
* Incapable to communicate
SKOLKONTAKT - Social Skills Training in a School Setting

The study investigates the behavioral effects of an adapted manual-based social skills training program (SKOLKONTAKT) for the mainstream education plan delivered by school personnel, with pupils (15-20 years) with social-communication needs; either formally diagnosed (i.e. autism spectrum disorders or ADHD) or teacher-reported subclinical difficulties. N=40 are recruited from a community school in the Stockholm area (Sweden).

So far, research has failed to consider the effectiveness of social skills training in school settings, and has instead focused on clinical or laboratory settings. This approach presents an interesting paradox given that the primary goal of social skills training is to affect change in the child's behavior in everyday life including school. Research undertaken in authentic everyday environments is not only more likely to result in real world outcomes for children and adolescents with ASD and ADHD, but greater utility in guiding models of service delivery. The objective of the current line of research is to adapt and evaluate methods originally designed to support children and adolescents with ASD and ADHD in clinical settings ("KONTAKT"), to be feasible and effective in school settings, that can be conducted by school personnel, and are are applicable to children with autistic and inattentive, hyperactive-impulsive disorders, as well as other less defined special social needs ("SKOLKONTAKT").

Eligibility Criteria:
Inclusion Criteria:

* Formally diagnosed autism spectrum disorder
* Formally diagnosed attention deficit hyperactivity disorder
* Teacher-reported subclinical social-communication special needs

Exclusion Criteria:

* Severe psychiatric comorbidity that challenges administration of the group-intervention, including but not limited to severe oppositional defiant disorder
* Severe psychiatric comorbidity that makes the participant to vulnerable to participate in the group-intervention, including but not limited to suicidality, severe depression
Prophylactic Trimethoprim/Sulfamethoxazole to Prevent Severe Infections in Patients With Lupus Erythematous

The purpose of this study is to determine whether trimethoprim/sulfamethoxazole is effective in preventing serious infectious complications (those that require hospitalization or lead to death) in patients with lupus erythematosus that receive intermediate or high dose steroids.


Eligibility Criteria:
Inclusion Criteria:

* Systemic Lupus Erythematosus according to the American College of Rheumatology Criteria
* On a daily dose of prednisone of ≥ 15 mg/d or equivalent, and that are expected to remain on the this dose for at least 1 month.
* Have signed an informed consent

Exclusion Criteria:

* Absolute contraindication to receive TMP-SMX (known allergy to TMP-SMX or sulfa drugs; TMP-SMX induced thrombocytopenia)
* Received TMP-SMX treatment in the previous month
* Creatinine clearance \<30ml/min/m2
* Chronic viral infection (Hepatitis C virus, Hepatitis B virus, Human immunodeficiency virus)
* Malignant neoplasm, except for skin neoplasm
* Primary immune deficiencies
* Solid organ or hematopoietic stem cell transplant recipients
* Pregnancy or Breastfeeding
* Current active infection, except mild active infections that to the judgement of the primary investigator do not jeopardize the study outcomes (e.g. tinea).
* Uncontrolled chronic infection (e.g. tuberculosis- intensive phase treatment), except mild active chronic infections that to the judgement of the primary investigator do not jeopardize the study outcomes (e.g. onychomycosis).
* Controlled chronic infection, that needs to be treated or prevented with TMP-SMX.
* Absolute Neutrophil Count \< 750/mm3, platelets \<30x10\^9/L, o hemoglobin \<7 g/dL
* Patients receiving Methotrexate
* Patients participating in another research study that to the judgement of the principal investigator could jeopardize the safety or efficacy of the study drug.
Effect of Exercise on the Absorption of Inhaled Human Insulin in Subjects With Type 1 Diabetes

The trial is conducted in Europe. This clinical pharmacology trial investigates the effect of exercise on the pharmacokinetics and pharmacodynamics of inhaled insulin in subjects with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes more than or equal to 12 months
* Baseline HbA1c less than or equal to 11%
* Body mass index (BMI) less than or equal to 29 kg/m2
* Normal lung volumes
* Treatment with intensified insulin therapy for at least 3 months

Exclusion Criteria:

* Any present or history of pulmonary disease
* Any findings from the cardiopulmonary exercise test compromising safety of moderate exercise
* Impaired hepatic or renal function
* Cardiac problems
* Uncontrolled hypertension
* Current proliferative retinopathy or maculopathy
* Treatment with drugs, which may interfere with insulin action, glucose metabolism or recovery from hypoglycaemia (judged by investigator)
* Current smoking or smoking within the last 6 months
* Blood donation (more than 500 mL) within the last nine weeks
Effects of Whole-body Vibration Exercise on Stroke Patients

The purpose of this study is to investigate the effect of the whole body vibration exercise on cortical activity and gait function in patients with chronic stroke.

Whole body vibration exercise can provide proper somatosensory stimulation and improve muscle strength and postural control in stroke patients. However, there has not yet been a report on the cortical activity changes induced by whole body vibration exercise.

Patients will be randomly assigned to one of the two groups. One group will go through whole body vibration with exercise and the other will only perform exercise. The primary outcome measurement of this study was cerebral cortex activity based on changes in oxygenated hemoglobin concentration using functional near-infrared spectroscopy. Behavioral assessments were performed before and after the intervention session using the 10-meter walk test, timed up and go test, Fugl-Meyer Assessment, and Tinetti Performance Oriented Mobility Assessment.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral stroke with hemiplegia
* 3 months after stroke onset
* Able to walk at least 10 meters without assistive devices

Exclusion Criteria:

* Subjects under 18 years and above 80 years old,
* Unable to perform a half squat on a vibrator (eg. visual field defects, fracture, and severe muscle paralysis)
* Musculoskeletal disorders
* Risk of falling due to dizziness
* Pregnant women