cyrilzakka/clinical-trials huggingface dataset:
Comprehensive Geriatric Assessment and Complications Following Lung Resection for Lung Cancer

schema : Prospective prognostic study The main objective is to study the value of the Comprehensive Geriatric Assessment in predicting the risk of post operative complications after lung resection for cancer.

Primary outcome :

Post-operative morbidity at 30-day :

Post operative complications occurred during 30 days post surgery, evaluated with CTCAE V3.0, and Complications grade 2.3.4 will be analyzed from day 1, at day 20 up to day 30.

Evaluation :

Pre operative : Day -30 to Day 0, Post operative : Day 10, Day 30, Day 90, Day 360.

Secondary outcome :

Post-operative mortality, Length of post operative hospital stay, Length of intensive care unit stay, QOL assessment, One year survival.

Eligibility Criteria:
Inclusion Criteria:

* Patient 70 years and more
* Lung tumour of clinical staging I to IIIB receiving curative lung resection

Exclusion Criteria:

* Diagnosis of non small lung cancer invalidated by the histological findings of the operative sample
* psychological conditions, social support or geographical conditions not allowing the study follow up
* Pre operative chemotherapy or radiotherapy
Plantar Fasciitis Treated With Dynamic Splinting

The purpose of this study is to determine if the Ankle Dorsiflexion Dynasplint System (DS) is effective in reducing pain from Plantar Fasciitis (Fasciopathy).

To determine the efficacy of Ankle Dorsiflexion Dynasplint System (DS) in treating patients with plantar fasciopathy, in a multi-centered, randomized, controlled, cross-over study.

Eligibility Criteria:
Inclusion Criteria:

Patients enrolled will have been DIAGNOSED with Plantar Fasciitis which is associated with significant pain and includes the following:

* Pain on the bottom of the heel
* Pain that is usually worse upon arising or after long periods of non weight bearing
* Pain that increases over a period of months
* Pain is worsened by walking barefoot on hard surfaces or by walking up stairs
* Morning mobility limitations
* Preference of patients to "walk on their toes"
* Paresthesias after non weight bearing (while sitting or lying down or both)
* Nocturnal pain
* Patients must be willing and able to sign the informed consent

Exclusion Criteria:

* Achilles tendon injury
* Acute traumatic rupture of the plantar fascia
* Calcaneal bursitis
* Calcaneal neuritis
* Calcaneal stress fracture
* Lumbosacral radiculopathy of S1 nerve root
* Retrocalcaneal bursitis
* Tarsal tunnel syndrome
Assessment of the Impact of Body Position on Diaphragmatic Excursion in Obese Patients to Improve Proactice in Respiratory Kinesitherapy

The EXDECHO study is the first randomized study evaluating the effect of four body positions on diaphragmatic excursion in obese patients by ultrasound.

The investigators suppose that the course of the right diaphragmatic hemicupola would be increased by an increasingly horizontal position (gradual increase in the diaphragmatic excursion from standing to lying down).

If this hypothesis is confirmed, kinesitherapists will have more informed positioning choices to improve the effectiveness of respiratory rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* to have a BMI greater than or equal to 30;
* to have not had intense physical activity during the hour preceding the measurements;
* to be enrolled in a social security plan;
* to give a written consent;
* to have underwent a pre-inclusion medicalexamination.

Exclusion Criteria:

* to have a respiratory pathology unrelated to obesity (sleep apnea syndrome, obesity-hypoventilation syndrome, restrictive ventilatory syndrome with no other known cause);
* to have a cardiac pathology not stabilized by drug treatment and/or resulting in heart failure and/or requiring the fitting of a pacemaker or defibrillator;
* to have a chronic inflammatory disease (rheumatoid arthritis, Crohn's disease, cirrhosis, etc.);
* to have a chest deformity (kyphoscoliosis, funnel chest, etc.);
* to be anactive smoking or former smoker (stopped for less than 3 months and total consumption \> 10 pack-years);
* to have an history of major surgery, surgery under general anesthesia for less than 3 months, or minimally invasive surgery for less than 1 year of the thoraco-abdomino-pelvic compartments;
* to have a known sensitivity to monopropylene glycol (substance present in the sterile ultrasound gel);
* temperature of the room in which the ultrasound measurements are carried out below 20°C or above 25°C;
* subject under a measure of legal protection.
Effect of EPD on the Lumbar Acoustic Window at Term Pregnancy

The purpose of this study is to assess whether application of an epidural positioning device to a parturient seated for neuraxial anaesthesia increase the size of the paramedian target area for neuraxial needle insertion. Lumbar ultrasonography will be performed in 30 pregnant women in two seated positions: (P1), lumbar flexion; and (P2), as in P1 with the epidural positioning device applied. For each position, the size of the 'target area', defined as the visible length of the posterior longitudinal ligament will be measured at the L3-L4 interspace.

Thirty term pregnant women will be recruited. Signed informed consent will be obtained from all subjects and demographic details, including age, weight, height and body mass index (BMI) will be documented. Randomization and blinding: Randomization will not be performed in this study, because each patient is their own control Interventions: Two experienced operators who have previously performed several hundred landmark-guided and ultrasound-assisted neuraxial blocks will perform the clinical and ultrasound examination.. The patient will then be placed in each of the positions described below. While in each of the positions an ultrasound (US) probe will be placed at level L3- L4 at the paramedian position to visualize the paravertebral longitudinal ligament (PLL) . These measurements will be recorded by an observer. In both phases (first US operator and second US operator ), 2 ultrasound measurements will be made for each of the following positions at 1 lumbar level in the paramedian view. These measurements will be made with the patient in the following positions: • Sitting position, feet supported with back flexed. • Sitting position, feet supported and arms supported through the application of an epidural positioning device. All images will be assigned a number based on a random number generator to remove any identifying data, including volunteer number, date, time, and position. The PLL will be remeasured on every saved image by two separate anesthesiologists ('readers') who are not involved with any previous data collection but are members of the study team. Both will be blinded to the number allocation and each other's measured values. This aim to remove any bias by the 'scanning' anesthesiologists and test for reproducibility in the measurement of the PLL, between 'readers'. A statistician calculated a minimum sample size of 30 subjects, in order to demonstrate significant change in the mean length of the PLL (acoustic target area), in any of the two positions. This estimation was based on data derived from a similar study, which had used a minimum sample size of 16 subjects, with a 1 mm mean change in 'needle target area' dimensions, a 1 mm standard deviation (SD), and an alpha of 0.05 with a power of 90 % \[1, 2\].

Eligibility Criteria:
Inclusion Criteria:

* Female Patients
* Term Pregnancy (\>37 weeks)
* 18 years or older
* Non-labouring patients, admitted for a cesarean delivery

Exclusion Criteria:

* Allergy to ultrasound jelly
* Spinal Deformities
* Active Labour
* Presence of Epidural Catheter for Labour Analgesia
Determination of the Efficacy and Safety of Psoralait Versus Placebo in the Treatment of Psoriasis

The purpose of this study is to determine the safety and efficacy of a new product, Psoralait, as compared to a placebo in the treatment of psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have been clinically diagnosed as suffering from psoriasis and are or aren't scheduled for Narrow Band Ultraviolet B (UVB)phototherapy of affected areas,excluding face and genitalia.

Exclusion Criteria:

* Women who are pregnant, lactating, planning to become pregnant, or women of child-bearing potential who have not successfully been using the same medically acceptable contraceptive methods over the previous 3 months, e.g., oral contraceptive agents, intrauterine device (IUD) and barrier method plus spermicide.
* Use of topical anti psoriatic therapy (including topical retinoids, corticosteroids, or vitamin D analogs) on the areas to be treated within 2 weeks prior to the beginning of the study.
* Received systemic biologic therapy to treat psoriasis (for example: alefacept, etanercept, infliximab, adalimumab) within 12 weeks prior to the beginning of the study.
* Received systemic psoriasis therapy (for example: methotrexate, cyclosporine, systemic corticosteroids, retinoids such as acitretin) within 4 weeks prior to the beginning of the study.
* Received phototherapy (including laser), photo chemotherapy or climatotherapy within 4 weeks prior to the beginning of the study.
* Recent history (within past 12 months) of alcohol or substance abuse. Alcohol abuse will be defined as \>14 drinks per week (1 drink = 12 oz beer, 4 oz wine, or 1.5 oz distilled spirits).
* History of noncompliance to medical regimens or unwilling to comply with the study protocol.
* Participation in an investigational drug study within 30 days prior to the beginning of the study.
* Serious or unstable medical or psychological conditions that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study.
Efficacy and Safety of the Administration of Ondansetron Versus Habitual Clinical Practice for the Treatment of Vomiting in Children With Mild and Moderate Dehydration: Randomized Clinical Trial

This clinical trial is intended to evaluate the efficacy and safety of the administration of ondansetron in children with mild-moderate dehydration.

The target population will be children between 4 and 13 years old who present vomiting.


Eligibility Criteria:
Inclusion Criteria:

* Presence of at least 2 vomits in the last 4 hours.
* Negative tolerance test.
* Signature of the informed consent by the parents or legal guardians.
* Diagnosis of vomiting or diagnosis of acute gastroenteritis with vomiting.
* Patients weighing 15 kg or more.

Exclusion Criteria:

* Altered conciousness.
* Sospected acute abdomen (appendicitis, invaginations...).
* Suspicion or presence of obstructive disease.
* Known severe digestive disease (Chron´s disease, ulcerative colitis...).
* Suspected food poisoning.
* Allergy to any of the drugs used in the study.
* Severe dehydration.
* Bilious vomiting.
* Previous abdominal surgery.
* Pathology that may affective degree of hydration of the patient (kidney failure, hypoalbuminemia..).
* Admission requirement or intravenous rehydration for any reason.
* Concomitant use of apomorphine.
* In relation to the possible lengthening of the QT, patients with problems of previous arrhythmia should be excluded or that they are receiving concomitant medication that can lengthen the QT, that have electrolyte disturbances.
* Patients receiving other serotonergic drugs.
* Patients who have undergone a previous adenotonsillectomy.
* Patients with hypocalcemia and/or hypomagnesemia.
* Patients with hereditary fructose intolerance.
* Diabetes patients.
* Lactose intolerant patients.
* Patients with indication of the low sodium diets.
* Hypersensitivity to ondansetron or other antagonists of the 5-HT3.
To Evaluate the Safety, Local Tolerability, PK and PD of LDE225 on Sporadic Superficial and Nodular Skin Basal Cell Carcinomas (sBCC)

This was a double-blinded, randomized, vehicle-controlled study in sporadic superficial BCC (sBCC) and nodular BCC (nBCC) patients which consisted of a 21-day screening period, a treatment period of 6 weeks (topical 0.75% LDE225 cream application b.i.d) ending with post treatment biopsies, as safety visit one week after final study drug administration (Day 50), a visit on Day 83 for excision of the treated BCC, and an end of study evaluation (Day 90).


Eligibility Criteria:
Inclusion Criteria:

* Patients with one histologically confirmed superficial and nodular basal cell carcinoma (8-20 mm) eligible for surgical excision on selected body areas (scalp, arm, frontal trunk, posterior trunk, upper legs)

Exclusion Criteria:

* Previous treatment of the sBCC that are selected for treatment.
* Any systemic treatment which is known to affect BCCs esp. cytostatic treatments, retinoids and photodynamic treatments.
* Dark-skinned persons whose skin color prevents readily assessment of skin reactions

Other protocol defined Incl./Excl. criteria may apply.
Implications of Stress Management Program

Previous studies indicated that patients with diabetes mellitus and hypertension had higher level of perceived stress, used maladaptive coping strategies and poor health-related quality of life. Therefore, stress management program was applied to reduce their perceived stress, improve their coping strategies, improve their health-related quality of life and psychological health of the patients with type 2 diabetes mellitus and hypertension in current study. The main objectives of the current study were to observe the effects of stress management program on perceived stress, coping strategies and health-related quality of life using pre-experimental research design. Patients with diabetes mellitus type 2 and hypertension were selected through purposive sampling technique to apply the eclectic approach of the stress management program. Total 110 patients with type 2 diabetes and hypertension completed the program from 114 patients who gave inform consent for participation in the first session. Perceived stress scale, WHOQOL and Coping strategies questionnaire were administered at the pre and post-levels of the program. Further, base line of targeted domains variables was also filled from the participants at pre, mid and post-levels to access the efficacy of the program which was formulated according to previous research data by the researcher. The stress Management program consisted of 10 session which were delivered to eight groups (diabetic and Hypertensive) in five weeks. Each session had the duration 90 minutes and two sessions were conducted in one week.


Eligibility Criteria:
Inclusion Criteria:

* patients with type II diabetes or hypertension with at least three months duration of illness
* had not attended any psychological intervention or stress management program earlier

Exclusion Criteria:

* Patients who had any other physical/ mental illnesses along with diabetes or hypertension
* Patients with type I diabetes
* Patients with gestational diabetes or hypertension
* Had diabetes or hypertensive condition from less than three month
* Had co morbidity of diabetes and hypertensive chronic conditions
Using Tests in Preschool Children With Wheeze to Determine the Need for Inhaled Corticosteroid Therapy.

Wheezing is common in preschool children and affects quality of life. Although asthma treatments such as inhaled steroids (ICS), which reduce swelling (inflammation) in the airways are used in this age group, they are often ineffective. That is because only some preschool children have the type of inflammation (known as Type 2 inflammation) that responds to ICS, thus many children are being unnecessarily exposed to side effects. It is difficult diagnosing Type 2 inflammation through history and examination, thus other indicators are needed to ensure ICS are only given to children who will benefit. These indicators are commonly known as biomarkers, and we are trying to find out if they are useful. We want to measure three biomarkers, without changing children's treatment. The first is blood eosinophils. which can be measured using a finger prick sample (like the blood drop used for measuring sugar levels in diabetic children). The second is to determine if allergic sensitization is present to allergens that are breathed in; these will be house dust mite, grass pollen, tree pollen, cat and dog hair. The final biomarker is a molecule that is produced in the airways of preschool children with Type 2 inflammation, called nitric oxide (NO). This is easily obtained, by having children breathe through a mask and collecting their breath in a bag, measuring NO later on. The children will be followed up with monthly electronic questionnaires and 3-monthly visits (virtual or face-to-face) for a year to evaluate whether these markers individually or in combination relate to subsequent wheezing outcomes, and how acceptable the measurements are to families using a questionnaire and focus group approach. The results will form the basis of the design of a national trial of biomarker-driven therapy in such children.


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged one to five years old presenting to primary care or emergency department or urgent care centre or identified from primary care records and have been diagnosed with wheezing by their GP or paediatrician who has decided to prescribe any bronchodilator, ICS or montelukast on clinical grounds
2. Parents/Carers able to understand and familiarize themselves with the study and are willing to provide informed consent

Exclusion Criteria:

1. Inability to understand and cooperate with study procedures
2. Significant co-morbidity (respiratory or otherwise), for example cystic fibrosis (excluding atopic disorders such as eczema, allergic rhinitis and food allergy)
3. Withholding or withdrawal of informed consent
4. Severe procedural anxiety (needle phobia)
5. Child is already enrolled in another study involving investigational medicinal product (CTIMP)
6. History of anaphylaxis or near-fatal asthma that resulted in intubation / assisted ventilation.
Augmenting Reactive Stepping With FES After SCI

Up to 25 individuals living with chronic incomplete spinal cord injury (iSCI) who can stand but have limited ability to elicit a step without physical assistance or upper limb (U/L) support will be recruited for this study. The first objective of the study will aim to investigate the orthotic effect (i.e., immediate effect) of FES on the reactive stepping response. The second objective is to investigate the therapeutic effect of a novel balance intervention, perturbation-based balance training (PBT) combined with FES (i.e., PBT+FES) on reactive stepping ability, measures of postural sway during quiet standing (i.e., biomechanical measures), and scores on clinical measures of balance and walking.


Eligibility Criteria:
Inclusion Criteria:

1. have a motor incomplete SCI (i.e., AIS grade C or D) that is non-progressive;
2. be at least one year post-injury (i.e., chronic injury);
3. ≥ 18 years old;
4. be able to stand independently for 60 sec;
5. unable to take a step bilaterally without physical assistance or upper extremity support;
6. able to understand spoken English;
7. free of any other condition besides SCI that significantly affects walking or balance (e.g., no vestibular disorder, significant vision loss, stroke);
8. be able to provide informed, written consent.

Exclusion Criteria:

1. Contraindications for EMS. Electrical stimulation will not be used if:

   * it will be applied to areas where it could cause malfunction of electronic devices, including cardiac pacemakers;
   * a woman is pregnant;
   * the applied region has known or suspected malignancy;
   * the person has active deep vein thrombosis or thrombophlebitis;
   * there are active bleeding tissues, or the person has untreated hemorrhagic disorders;
   * there are infected tissues, tuberculosis, or wounds with underlying osteomyelitis;
   * tissues have been radiated in the past six months;
   * there are damaged skin areas or at-risk skin areas that would result in uneven conduction of current;
2. severe spasticity is present in the legs;
3. the person has contractures in the lower limbs that prevent achieving a neutral hip and ankle position, or extended knee;
4. there is a history of prior lower limbs fragility fracture;
5. the leg muscles are unresponsive to electrical stimulation (i.e., peripheral nerve damage in the legs).
6. Pressure sores on pelvis or trunk, where safety harness will be donned.
Developing and Validating the Caring Questionnaire of Service Learning Courses

Research purposes: 1. Construct the caring scale in service learning courses. 2. Verify the reliability and validity of caring scale in service learning curriculum.

Background: The core value of healthcare education is caring. However, caring traits are learned and acquired. Service learning advocates learning by doing. Through experience learning, students are guided to learn caring attitude or caring behaviour. Thus, teachers should construct appropriate assessments to understand caring traits as a transformative process from students' learning. Teachers should also adjust the pace of teaching continuously and design appropriate courses to facilitate students' achievement of their learning goals.

Eligibility Criteria:
Inclusion Criteria:

* undergraduate students after attending a service learning course

Exclusion Criteria:

* undergraduate students who refuse or are unwilling to participate in service learning courses.
Effect of Estrogen Treatment on Drug Metabolism and Transport

This project will evaluate the effect of gender-affirming estrogen treatment on how other medications are processed by the body.

Gender-affirming hormone therapy may include estradiol, a hormone that the body creates and uses naturally. Estradiol is prepared as a medication that patients may take to increase hormone levels. Changes in estradiol concentrations in the body may affect how the body processes other medicines. The purpose of this study is to find out how estradiol therapy affects a single tracer dose of approved medicines in the blood (midazolam, digoxin, and acetaminophen) and to confirm estradiol treatment does not affect natural bacterial in the gut.

Eligibility Criteria:
Inclusion Criteria:

* Self-identified trans\* adult 18-55 years of age.
* Not taking estradiol treatment currently.
* Planning to start injectable estradiol or estradiol tablets for gender-affirming medical care.

Exclusion Criteria:

* Unwilling/unable to return for project follow-up visits.
* Unwilling/unable to provide written informed consent.
Consistency Between Measures of Renal Function in ICU Patients

This study aim to compare different measures of renal function (glomerular filtration rate) in ICU patients.

The study uses a large dataset of prospectively collected data according to clinical routines.

Eligibility Criteria:
Inclusion Criteria:

* ICU patients with at least one measurement of urinary creatinine clearance

Exclusion Criteria:

* Renal replacement therapy initiated before the measurement of creatinine clerance