cyrilzakka/clinical-trials huggingface dataset:
Effects of Succinylcholine on Nonintubated Thoracoscopic Surgery

A safe and effective surgical environment is important for nonintubated thoracoscopic surgery. The investigators hypothesize that mini-dose succinylcholine can induce ultra-short period of apnea, by which the ventilatory responses to open pneumothorax were abolished and may facilitate rapid and satisfying collapse of the operated lung during nonintubated thoracoscopic surgery.

Background: Nonintubated thoracoscopic surgery is the frontier of modern minimal invasive thoracic surgery. A safe and effective surgical environment is established via an iatrogenic open pneumothorax producing the operated lung fully collapsed. However, the initial respiratory response to open pneumothorax is both tachypnea and carbon dioxide rebreathing, which would jeopardize the quality of collapse of the operated lung and delay the performance of intrathoracic vagal block. Intravenous opioid is effective to attenuate ventilatory responses but herein with risk of persistent respiratory depression.

Methods: The investigators hypothesize that mini-dose succinylcholine 0.15 mg/kg can induce ultra-short period of apnea, by which the ventilatory responses to open pneumothorax were abolished and may facilitate rapid and satisfying collapse of the operated lung during nonintubated thoracoscopic surgery. In a prospective, randomized, double-blind study design, 30 patients will be allocated to receive either succinylcholine (n=15) or placebo (n=15) in the beginning of open pneumothorax. The effectiveness of succinylcholine will be measured by the surgeon's evaluation of the quality of lung collapse, while the safety will be evaluated by determination of arterial blood gases within 20 minutes of one-lung spontaneous breathing.

Expected results: Mini-dose succinylcholine can facilitate early lung collapse without jeopardizing the ventilatory function during nonintubated thoracoscopic surgery with one-lung spontaneous breathing, which may make nonintubated thoracoscopic surgery easier and safer.

Eligibility Criteria:
Inclusion Criteria:

* Adults patients with lung tumors and elective for unilateral thoracoscopic surgery.

Exclusion Criteria:

* Over weighted, body mass index \> 26 kg/m2.
* Previous thoracic surgery on the attempted operative side.
* Hypoventilation syndrome requiring positive pressure ventilatory support or oxygen at home.
* Relevant systemic disease, including heart failure, liver failure, renal failure with an American Society of Anesthesiologists (ASA) class above 3.
* Difficult airway management.
* Pregnancy.
* Contraindications for succinylcholine, including family history of suspicious malignant hyperthermia, hyperkalemia, or other neuromuscular diseases.
OCAST Cessation Study

The long-term goal is to improve the quality of life of children and their parents who smoke tobacco by facilitating parental smoking cessation in a way that is easy to administer yet effective. We aim to accomplish this goal by administering an interactive computer-based program that will facilitate motivation and readiness to engage in smoking cessation by providing personalized feedback about the financial and health effects of the parent's smoking. We will compare the changes in motivation and readiness to quit smoking after the parent has taken the computer-based program and compare them to the changes in motivation and readiness to quit in parents who receive only information about the Oklahoma Tobacco Helpline. We will also measure salivary cotinine levels in both parents and children, to objectively measure changes in smoking habits and secondhand smoke exposure. Our hypothesis is that our computer-based program will cause a greater increase in motivation and confidence to quit smoking in the group that receives the customized feedback than the group that receives only information about the Tobacco Helpline. We also predict that both parent and child cotinine levels will show a greater decrease in the group randomized to receive personalized feedback.


Eligibility Criteria:
Inclusion Criteria:

* Parent or primary caregiver of a child patient at the OU Children's Physicians General Pediatrics clinics
* Current cigarette user
* Able to read study forms and verbally communicate with the study staff in English

Exclusion Criteria:

* Nonsmokers
* Unable to read or speak English well enough to complete the survey and study tasks
Antifungal Prophylaxis in Intensive Care Unit (ICU) Patients

Purpose. Oral chemoprophylaxis has been advocated to reduce the incidence of Candida colonization and infection. However, Candida prophylaxis in intensive care unit (ICU) is still a matter of debate.

Methods. Randomized, single-center trial studying single drug (nystatin) versus control in surgical ICU patients. Multiple-site testing for fungi were performed in each patient at ICU admission (T0) and subsequently every 3 days (T3, T6, T9...). The primary evaluation criterion was the time course of colonization index (CI) during ICU stay.

Multiple-site testing for fungi included: tracheal secretions, pharingael swab, stomach contents, rectal swab, groin skin fold swab, urine, and blood. These tests will be performed in each patient at ICU admission (T0) and subsequently every 3 days throughout the ICU stay (T3, T6, T9...), as routine in our ICU.The specimens were placed in a dry medium and taken to the Mycology Laboratory. Group assignment was not indicated on specimens, the mycologists were therefore blinded to treatment allocation.

Each specimen was directly microscopically examined and cultured on Sabouraud media.

Eligibility Criteria:
Inclusion Criteria:

* surgical patients admitted to our ICU older than 18 years of age and expected to require invasive mechanical ventilation for more than 48 h.

Exclusion Criteria:

* pregnancy,
* proven Candida infection,
* prophylactic or curative antifungal treatment within the last 2 months,
* contraindication to oral drug administration,
* known allergy to nystatin or its derivatives, and prior inclusion in the study
Stereotactic Ablative Radiotherapy for Oligo-Progressive Non Small Cell Lung Cancer

A registry-based randomized screening phase II trial. A total of 68 patients with metastatic non small cell lung cancer on systemic therapy with oligoprogression to 1-5 extracranial lesions will be randomized using a 1:1 ratio to standard of care (begin next-line systemic therapy, best supportive care, continue current systemic line, based on treating physician decision) vs. receive stereotactic ablative radiotherapy to all oligoprogressive lesions while continuing their current systemic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Metastatic NSCLC enrolled in our CRCHUM Lung Cancer Registry and co-enrolled to the PERa registry
* Ability to provide written informed consent
* Eastern Cooperative Oncology Group (ECOG) performance status 0-3
* Oligoprogression to 1-5 extracranial lesions ≤ 5cm and involving ≤ 3 organs. Progression at the primary tumor site should be counted within the total of 5 lesions. For patients with lymph node metastases, each node is counted as one site of metastasis.
* Oligoprogression while on ICI or TKI (any line)
* Patients with brain metastasis are allowed; brain metastasis are not counted in the maximum number of lesions and should be treated as per standard of care
* All sites of disease can, in the opinion of the investigator, be safely treated and targetable with SABR (taking into account prior local therapy, organ function and underlying medical condition such as inflammatory bowel disease, pulmonary fibrosis, etc.)
* Patients with prior metastases that have been treated with ablative therapies (e.g. radiotherapy, surgery or radiofrequency ablation) before their current line of systemic therapy, are eligible.

Exclusion Criteria:

* Any lesion beyond 5 cm
* Pregnancy or breastfeeding
* Any medical condition that could, in the opinion of the investigator, preclude radiotherapy or prevent follow-up after radiotherapy.
* Presence of spinal cord compression Metastatic disease that invades the GI tract (including esophagus, stomach, small or large bowel)
Clinical Efficacy in Relief of Dyspnea by HVNI: Evaluation of New Device Equivalence

This study will evaluate the ability of a new High Velocity Nasal Insufflation \[HVNI\] device design to effect ventilation and related physiological responses relative to the current HVNI device design.

The objective of this study is to evaluate the ability of a new HVNI device to improve ventilation, dyspnea, and related physiological responses relative to the conventional Precision Flow device design, with which there are published clinical outcomes data. It is hypothesized that the new HVNI device design (V2.0) will be comparable at relieving patient dyspnea when compared to the conventional HVNI device design (Precision Flow).

Eligibility Criteria:
Inclusion Criteria:

* Adult inpatients (18 years of age and older)
* Demonstrated severe dyspnea at baseline (Borg Rated Perceived Dyspnea \[RPD\] (scale 0-10) of 3 or higher)
* Severe baseline hypercarbia/hypercapnia of 55 mmHg or higher as measured by TcPCo2 or arterial or venous blood gas

Exclusion Criteria:

* Patient has unstable cardiovascular condition
* Significant unilateral or bilateral nasal occlusion
* Inability to provide informed consent
* Pregnancy
* Known contraindication to perform steps of the protocol
* Absence of spontaneous respiration or known contraindication to HVNI
* Inability to use HVNI therapy
* Agitation or uncooperativeness
* Determined by the clinician to be sufficiently unstable or unsuitable for this study
Estrogens Effect on Pain in Postmenopausal Women Suffering of Fibromyalgia

In order to evaluate the potential effects of estrogen treatment in postmenopausal women with fibromyalgia, the investigators used quantitative sensory tests before and after eight weeks of estrogen treatment as compared with placebo treatment.

Fibromyalgia is a condition that preferentially affects women. Sex hormones, and in particular estrogens, have been shown to affect pain processing and pain sensitivity, and estrogen deficit has been considered a potential promoting factor for fibromyalgia. However, the effects of estrogen treatment in patients suffering from fibromyalgia have not been studied. Twenty-nine postmenopausal women were randomized to either eight weeks of treatment with transdermal 17β-estradiol (50 ug daily) or placebo according to a double-blind protocol. A self-estimation of pain, a set of quantitative sensory tests measuring thresholds to temperature, thermal pain, cold pain and pressure pain, and a cold pressor test were performed at three occasions: before treatment, after eight weeks of treatment, and twenty weeks after cessation of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Between 49-60 years
* Body mass index (BMI) of \< 30
* Met the ACR-90 criteria for the diagnosis of fibromyalgia
* Postmenopausal state since at least six months
* Not been using any hormonal treatments for the past three months
* Had normal mammography screenings

Exclusion Criteria:

* Using psychotropic drugs or having a history of thromboembolism
* Diabetes mellitus, polyneuropathy, chronic liver disease,
* Alcohol or substance abuse, hemoglobinopathy,
* Endometrial adenomatous hyperplasia, or malignancy.
* Presence of untreated hypertension (\>160/95).
* Undiagnosed vaginal bleedings
The Effect of Central Blood Pressure on Clinical Outcome in Diabetic Hypertensive Patients in Assiut University Hospitals

In recent decades, some observational studies suggest that peripheral BP measured by brachial artery may not necessarily represent BP measured in the aortic artery which is known as central BP .In addition, some clinical trials also revealed that despite with comparable peripheral BP, patients with high central BP had significantly higher cardiovascular risk compared with those with low central BP indicating that central BP might be an independent predictor for CVD

Diabetes mellitus (DM) is amajor risk factor for cardiovascular and renal diseases\[1\] .It is known about two thirds of diabetic patients died from these complication .Numerous epidemiological studies demonstrate that DM is commonly accompanied with hypertension and patients with diabetes and hypertension have higher renal and cardiovascular risks compared with those with either hypertension or diabetes. Therefore, better evaluating and managing BP in diabetic patients with hypertension is clinically relevant.

Hypertension also is a major risk factor for cardiovascular diseases (CVD) and all-cause mortality . Numerous randomized controlled trials using antihypertensive drugs and meta-analysis demonstrate that lowering peripheral blood pressure (BP) is beneficial for reducing cardiovascular and renal events.

In recent decades, some observational studies suggest that peripheral BP measured by brachial artery may not necessarily represent BP measured in the aortic artery which is known as central BP.

In addition, some clinical trials also revealed that despite with comparable peripheral BP, patients with high central BP had significantly higher cardiovascular risk compared with those with low central BP indicating that central BP might be an independent predictor for CVD

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 40 - 60 years old
* Patients in group A and B are documented to have type 2 DM
* Patients in group A are documented to have essential hypertension .
* Hypertensive patients enrolled must be compliant on their treatment for at least one month

Exclusion Criteria:

* Pregnancy or breastfeeding .
* Concomitant therapy of digoxin, lithium, non-depolarizing skeletal muscle relaxants, sex hormone .
* Documented rheumatic diseases such as systemic lupus erythematosus .
Functional Bioactive Supplement Effect in Lost Weight Treatment

The purpose this study is to evaluate the therapeutic effect of a functional bioactive supplement associated with a hypocaloric equilibrated diet to treat obese and overweight individuals. The functional bioactive supplement, containing antioxidant extracted from rosemary, oligosaccharides derived from lactulose and bioactive peptides, was developed to satiety control, improves of anti-inflammatory response and antioxidant defense mechanisms as well as to weight loss.

A randomized, parallel, double-blind, controlled was performed to evaluate the therapeutic effect of a functional bioactive supplement associated with a hypocaloric equilibrated diet to treatment of obesity and overweight.

Women aged between 18 and 65 years with obesity and overweight diagnosis (IMC \>25\<35 kg/m2) were included in the study. The clinical trial will be performed in the Clinical Nutrition Department of La Paz University Hospital, in Madrid. All of the volunteers will receive a dietetic treatment with 1500 Kcal/day and physical activity recommendations during the study.

Eligibility Criteria:
Inclusion Criteria:

* Women from 45 to 75 years old;
* Overweight (IMC ≥25\<30 Kg/m2) or obese (IMC ≥30\<35 Kg/m2) volunteers
* Signed informed consent.

Exclusion Criteria:

* Subjects with drug consumption (lipid-lowering, oral hypoglycemic agents and / or hypertensive) in less than one month period;
* Subjects with Diabetes Mellitus insulin dependent;
* Individuals that stop smoking in the next 12 weeks (during the study);
* Subjects with increased alcohol consumption (\> 1 glass of vine);
* Subjects that consume drugs, vitamins, minerals, prebiotics or/and probiotics that interfere with the body's response to the extracts in the 2 weeks before to baseline;
* Subjects with drugs consumption special diet due to disease as celiac disease, chronic renal failure, etc;
* Subjects with disorders associated with eating behaviour;
* Subjects with drugs or supplements consumption to weight lost;
* Subjects with physical problems complying with the recommendations of physical activity and diet indicated;
* Subjects who refuse to perform the indicated dietary changes throughout the study;
* Subjects with diseases that could be involucrate in weight lost (not controlled hypothyroidism, serious psychiatric illness, etc.);
* Subjects with mental disease or low cognitive function;
* Subjects with severe diseases (hepatic, kidney, cancer...);
* Pregnant women or lactating;
* Subjects with physical problems complying with the recommendations of physical activity.
* Subjects with intensive physical activity;
Exercise in Asymptomatic Pre-Alzheimer's Disease Pilot Study

Researchers are trying to determine if cognitively normal subjects undergoing a moderate aerobic exercise program will accumulate less amyloid-ß (Aβ) concentration in their brain than subjects undergoing a non-aerobic exercise program, and further evaluating the safety and imaging characteristics of florbetapir F 18, the radioactive drug that will allow us to image changes in the brain amyloid-ß (Aβ).

After screening assessments have been completed, subjects will be randomized into one of two groups: aerobic exercise group and non-aerobic exercise group. All subjects will be trained on the Physical Activity Scale for the Elderly (PASE), using the Body Media armband, and exercise diary. Subjects will also complete an online food questionnaire.

Subjects assigned to the aerobic exercise group will work with an exercise trainer who will provide individual training (six half hour sessions) until they are proficient at the use of the equipment and understand goals. Subjects will return to Brooks Family YMCA at their convenience, but at a minimum of four times per week. Subjects will complete the exercise journal daily and the Physical Activity Scale for the Elderly (PASE) questionnaire on a monthly basis.

Subjects assigned to the non-aerobic exercise group will attend supervised classes on toning and stretching at a minimum of four times per week. Subjects will complete the exercise journal daily and the Physical Activity Scale for the Elderly (PASE) questionnaire on a monthly basis.

Eligibility Criteria:
* 65 years of age or older.
* Not diagnosed with memory problems.
* Do not exercise in which you sweat and/or raise your pulse rate more than 30 minutes two times per week.
* Able to walk ten blocks (about one mile).
* Willing to participate in weekly exercise classes at the Brooks YMCA for six months.
* Able to have an MRI and CT/PET scan.
Efficacy of Steroids on Functional Outcomes After Musculoskeletal Injuries of the Hand

Steroids are often prescribed for their anti-inflammatory effects in patients with musculoskeletal injuries. Studies have shown that steroids may reduce pain and swelling, but their effects on range of motion and functional outcomes have not been illustrated. With this study, we aim to evaluate the effect of steroids on range of motion and functional outcomes in non-operatively managed musculoskeletal injuries of the hand.

Previous studies have investigated the effect of steroids on bone healing, edema reduction and postoperative pain. However, there seems to be a lack of literature on whether the use of steroids for their anti-inflammatory effects actually lead to improved range of motion and functional capacity. If the data shows that steroids do indeed help patients achieve increased functional outcomes, they may be used with higher confidence in their beneficial contribution to patient treatment and quality of life. If, however, the data show that steroids do not confer a significant benefit, they can be disregarded as they will avoid the risks associated with steroid use. We aim to investigate if the use of methylprednisolone will result in significantly improved ranges of motion and self-reported function compared to a control group at each measurement time point.

Eligibility Criteria:
Inclusion Criteria:

* Patients with soft tissue injuries and stable fractures from the metacarpophalangeal joint to the distal phalanx

Exclusion Criteria:

* Patients at increased risk of serious side effects of steroid administration.
* Patients unable to provide consent
* Unable to swallow oral medications
* Pregnant women
* ages less than 18 years old
CALLSAS Study: Effect of Continuous Positive Airway Pressure Treatment for Obstructive Apnea on Phone Usage Habits

Continuous positive airway pressure (CPAP) treatment improves sleepiness, depression and social activities in patients with obstructive sleep apnea (OSA). This evolution can be captured from changes in phone usage habits coupled with a mobile-based services. The aim of this study is to assess the impact of CPAP treatment on phone usage habits in OSA patients.

Callsas is a prospective study embarking newly diagnosed obstructive sleep apnea patients initiated to CPAP treatment.

The primary objective is to analyze the modifications in phone usage habits before and after CPAP treatment.

Secondary objectives:

* Correlation between changes in phone usage habits and evolution of sleepiness
* Correlation between changes in phone usage habits and evolution of depression scale
* Correlation between changes in phone usage habits and evolution of quality of life
* Correlation between changes in physical activity measured by phones and evolution of physical activity objectively measured by actigraphy and gait platform
* Correlation between phone usage habits and CPAP adherence

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed OSA patients initiated on CPAP
* Follow-up at home by AGIR à dom
* Customers of Orange (or Sosh) for mobile and/or fixed-line telephony for at least 6 months
* Patient who signed a written consent to participate in the study
* Patient affiliated to social security

Exclusion Criteria:

* Pregnant women
* Patients with disease not allowing to realize functional and locomotion tests
* Person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure (patient under guardianship or curatorship)
* Patient who, in the judgment of the investigator, may not be cooperative or respectful of the obligations inherent to participation in the study