cyrilzakka/clinical-trials huggingface dataset:
Comparison of Three Treatment in Children With Cerebral Palsy

In this study, considering the importance of walking and balance functions in improving the quality of life and achieving independence in children with cerebral palsy, it was aimed to examine whether core stabilization exercises specifically designed for children with cerebral palsy have an impact on improving balance and walking functions as well as quality of life. Additionally, the study sought to determine whether this approach has superiority over conventional balance exercises.

Children with cerebral palsy included in the study were randomized into three groups using block randomization based on age, type of cerebral palsy and the Gross Motor Function Classification System (GMFCS). Children with cerebral palsy aged 7-18 years were included. Group 1 (study group, n=12) received neurodevelopmental therapy (NDT) combined with core stabilization exercises (CSE). Group 2 (study group, n=12) received NDT combined with balance exercises (BE). The control group (n=12) received only NDT. Treatments were conducted for 60 minutes per session, three times a week, over 8 weeks, for a total of 24 sessions, with an equal duration across groups. Participants' balance was evaluated using the Pediatric Balance Scale (PBS) and the SportKat 550® device. The Trunk Involvement Scale (TIS) was used to measure trunk impairment, the Six-Minute Walk Test (6MWT) to assess functional mobility and walking capacity and the Pediatric Outcome Data Collection Instrument (PODCI) to evaluate quality of life. All assessments were performed by the same physiotherapist before and after treatment

Eligibility Criteria:
Inclusion Criteria:

* Cases between the ages of 7-18
* Cases with GMFCS level I and II
* Cases diagnosed with hemiparetic and diparetic CP

Exclusion Criteria:

* Cases with levels III, IV and V according to GMFCS
* Having an intellectual disability that would prevent participation in assessment and exercise training
* Having had Botulinum Toxin (BOTOX) Type A application within the last 6 months
* Having undergone any surgical operation within the last 6 months
* Hearing and vision problems
ILM Inverted Flap Size in Macular Hole

In the current study, the investigators described the results of a randomized, comparative clinical trial that was conducted to study the impact of the size of internal limiting membrane (ILM) inverted flap on rate and timing of idiopathic macular hole closure.

A prospective randomized comparative study included patients with idiopathic macular hole (MH) attending outpatient clinic.Eligible eyes were divided into 2 groups based on the narrowest diameter of the MH measured by spectral domain optical coherence tomography (SD-OCT). MHs from 250 to 400µm were classified as Medium-sized MHs and MHs \> 400 µm were classified as Large-sized MHs. Within each group, eyes were randomly assigned to either small-flap (1-2DD) or large flap (from \>2 to 4DD).

Eligibility Criteria:
Inclusion Criteria:

* Eyes with stage 4 idiopathic MHs with a diameter \>250µm on spectral domain optical coherence tomography (SD-OCT)

Exclusion Criteria:

* traumatic MH
* myopic MHs,
* MH secondary to retinal detachment,
* long-standing MH\> 12 months
* previous retinal surgeries
* high myopia with an axial length \> 26.0 mm
* other ocular pathologies interfering with the interpretation of the OCT reports.
Analysis of Lung Cancer Tissue With Spatial Frequency Domain Imaging

This study investigates if a new imaging device can detect different types of lung tissue using spatial frequency domain imaging (SFDI). Specifically, this study aims to detect lung nodules within normal lung tissue and determine if lung nodules are cancerous. Patients who have confirmed or suspected lung nodules and who are undergoing resection of those nodules will be recruited for the study. Study participants will undergo standard of care lung nodule resection in the operating room, and the resected specimen will be imaged using the SFDI device immediately after removal from the surgical field. The data captured from the SFDI images will then be compared to the pathology findings to identify optical properties of normal and cancerous lung tissue. Because the intervention is conducted on resected biospecimens, this study yields minimal risk to participants.


Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 18 years old
* Suspected or confirmed lung nodule on diagnostic imaging
* Undergoing lung resection using an open, endoscopic, or robotic approach
* Standard of care orders placed for a pathology assessment of resected lung tissue
* Adults undergoing lung resection for a lung mass

Exclusion Criteria:

* \<18 years old
* Pregnant females and incarcerated individuals
* No standard of care orders to obtain a pathology assessment
* RUSH pathology order for resected lung tissue
* Any condition where the principal investigator determines to impact patient safety or quality of care
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Total Hip Replacement Surgery

The primary objective was to compare the efficacy of once daily \[q.d.\] subcutaneous \[s.c.\] injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of enoxaparin for the prevention of Venous Thromboembolic Events \[VTE\] in patients undergoing elective total hip replacement surgery.

The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing elective total hip replacement surgery, and to document AVE5026 exposure in this population.

Randomization had to take place just prior the first study drug injection (randomization ratio 1:1).

The total duration of observation per participant was 35-42 days from surgery broken down as follows:

* 7 to 10-day double-blind treatment period;
* 28 to 35-day follow-up period.

Mandatory bilateral venography of the lower limbs had to be performed 7 to 11 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Elective total hip replacement surgery or a revision of at least one component of a prosthesis implanted ≥ 6 months prior to study entry.

Exclusion Criteria:

* Any major orthopedic surgery in the 3 months prior to study start;
* Deep vein thrombosis or pulmonary embolism within the last 12 months or known post-phlebitic syndrome;
* High risk of bleeding;
* Known allergy to heparin or enoxaparin;
* Any contra-indications to the performance of venography;
* End stage renal disease or patient on dialysis.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study to Evaluate the Effect of ALNA® (Tamsulosin) on the Primary Symptoms of Benign Prostatic Hyperplasia

The aims of this observational study are to identify the primary BPH symptoms responsible for the patients to consult a urologic practice, resulting in the prescription of ALNA®, to assess the clincial efficacy on an improved occupational performance of the patients being still employed. Additionally to obtain relevant information for the 5-year report of experience with this product according to the requirements in § 49, para 6 of the German Medicines Act.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from symptomatic benign prostatic hyperplasia (BPH) symptoms and receiving ALNA® treatment are to be included in the observation according to the prescribing information

Exclusion Criteria:

No exclusion criteria is defined, prescribing information is to be considered
One-Leg Standing Radiograph: A Novel Technique to Evaluate the Severity of OA Knee

The purpose of this study is assess the severity of osteoarthritic knee between one-leg and both-leg standing radiograph in primary OA knee

All patients were performed digital radiographs which one-leg and both-leg standing anteroposterior view. Medial and lateral joint space width were measured. The severity of OA knee was identified by the Kellgren-Lawrence (KL) classification.

Eligibility Criteria:
Inclusion Criteria:

* Bilateral knee pain more than 3 months

Exclusion Criteria:

* Inflammatory OA knee
* previous knee injury
* previous knee infection
* previous knee surgery
* pregnant women
* unable to bear weight on one leg
Reduction of Asthma Exacerbation Rate in Children by Non-invasive Monitoring of Inflammatory Markers in Exhaled Breath (Condensate): the RASTER Study

The purpose of the present proposal was to investigate the predictive properties of markers in exhaled breath to predict an asthma exacerbation. In addition, the reliability of home monitor assessments to measure asthma control will be examined.


Eligibility Criteria:
Inclusion Criteria:

1. already known with a diagnosis of asthma during at least 6 months
2. age between 6 and 17 years
3. reversibility to a bronchodilator (increase in FEV1 \> 9% of predicted value and/or
4. bronchial hyperresponsiveness to histamine \< 8 mg/ml.

Exclusion Criteria:

1. cardiac abnormalities
2. mental retardation, congenital abnormalities or existence of a syndrome
3. active smoking
4. no technical satisfactory performance of measurements
5. no phone line or internet assess available at home.
Gastric Volume After Ingestion of Carbohydrate Drink vs Water in Obese Volunteers

This randomized crossover study compares gastric residual volume after ingestion of carbohydrate drinks and water in obese volunteers. The main question\[s\] it aims to answer are:

* Is it safe for obese patients to shorten their fasting by allowing preoperative drinks?
* How long is the gastric emptying time in obese patients? Participants also will be evaluated the level of thirst/hungry and blood sugar.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers
* Age 18 - 65 years old
* BMI ≥ 30 kg/m2
* NPO for at least 6 hours before the study

Exclusion Criteria:

* Diabetes Mellitus
* Chronic kidney disease or End-stage renal disease
* Use of any medication that affects gastric secretion or emptying (Histamine 2 receptor antagonist eg. Ranitidine/Proton pump inhibitor eg. Omeprazole/Acid neutralization eg. Aluminium hydroxide/Prokinetic eg. Domperidone) within the past 24 hours
* Gastroesophageal reflux disease
* Pregnancy
* History of upper gastrointestinal surgery
* In diet program or use appetite suppressant drug (eg. Liraglutide, Naltrexone, Phentermine, Diethylpropion) within the past 24 hours
The Distribution of Gingival Display and Possible Related Factors Resulting in Gummy Smile

This study primarily aimed to evaluate smile line distribution and prevalence of gummy smile in patients. The secondary purpose was to examine parameters that might be risk factors for gummy smile.

this study primarily aimed to evaluate smile line distribution and prevalence of gummy smile in patients. The secondary purpose was to examine parameters that might be risk factors for gummy smile.Age, gender, marital status, medical history, and medication status of the patients were recorded. All individuals were instructed to sit on a dental chair and the measurments were made by using a millimetric ruler.Next, the patients were grouped according to Liebart's classification by gingival display at maximum smile as follows: Class 1.Excessive gingival display (Gummy smile): ≥ 3mm gingival display Class 2.High smile line: 0-2 mm of gingival display Class 3. Average smile line: Dental papilla is visible. Class 4. Low smile line: Gingival margin, dental papilla is not visible at all. Presence of altered passive eruption, short lip and hypermobile upper lip were also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* presence of teeth in upper jaw
* Age between 18-65 years

Exclusion Criteria:

* Patients who have received and/or are receiving orthodontic treatment and patients who received gummy smile treatment were excluded.
Impact of Nuclear Human Sperm Quality on Embryo Development

To date, none study shows the impact of human spermatozoa nuclear alteration on embryonic development kinetic with morpho-kinetics tools. In this study, Investigator analyze the possible influence of sperm nuclear quality on embryonic development kinetics. Moreover, Investigator will evaluate possible new sperm biomarkers and try to better understand the pathophysiology of male infertility.

In recent years, there has clearly been a significant decline in male fertility in industrialized countries, particularly sperm quality. Furthermore, it is known that the quality of sperm DNA affects embryonic development and pregnancy outcomes. However, few elements are known about the effects of spermatozoa nuclear alterations on the embryonic development kinetics.

Thus, the aim of this study is to analyze the possible influence of sperm nuclear quality on the embryonic development kinetics. In order to answer this question, Investigator will study the spermatozoa quality of patients whose torque is supported by ICSI.

On these spermatozoa, Investigator will analyze DNA fragmentation, oxidation by measuring the 8-OHdG residues, chromatin compaction and nuclear methylation degree. This will allow to determine the spermatic nuclear parameters in relation to an ICSI fertilization rate (normal\> 60%) and a good blastocyst rate (≥ B3 in the Gardner classification).

And finally, by this study, Investigator will probably find new biological markers spermatic. Moreover, the data will help to better understand the physiopathology of male infertility.

Eligibility Criteria:
Inclusion Criteria:

* Couple whose wife is younger than 37
* First or second ICSI attempt at Clermont-Ferrand University hospital
* Spermatozoa's concentration after Percoll gradients discontinuous technique is greater than or equal 0.5 million of spermatozoa
* Number of oocytes injected in ICSI greater than or equal to 6

Exclusion Criteria:

* If ICSI performed with testicular, epididymal or frozen spermatozoa
* If one or both of the couple take antioxidant treatments
From Structural to Functional Characteristics of the Lumbar Multifidus in Low Back Pain

To delineate the underlying mechanisms that contribute to chronic low back pain, by extending our knowledge on structural characteristics of the lumbar multifidus muscle using ultrasound muscle imaging, and by examining the association of structural features with functional performance, more precisely proprioceptive control.


Eligibility Criteria:
Inclusion criteria for chronic low back pain group:

* Non-specific low back pain, during 3 or more months, without radicular leg pain
* Modified Low Back Pain Disability Questionnaire \> 20%
* Indication for MRI of the lumbar spine
* No contra-indications for MRI
* Informed consent to participate

Inclusion criteria for healthy control group:

* No history of low back pain needing medical treatment or resulting in limited activity level
* Any low back pain in the previous 3 months
* Informed consent to participate

Exclusion criteria for all subjects:

* Pregnancy
* Previous trauma or surgery to spine, abdomen or pelvis
* Structural deformity (e.g. scoliosis)
* Neurological/neuromuscular/systemic disease
* Inability to lie prone for 20 minutes
Pilot Study: Complementary Therapies in Geriatric Patients

In a randomized controlled pilot study the investigators include geriatric patients living in a geriatric residential community. Two interventions are compared:

1. a complex intervention containing exercise therapy, nutritional advice, homeopathy and naturopathy in addition to routine therapy by the general practitioner
2. routine care by general practitioner

The investigators assess the effect of the complex intervention on activities of daily living (AMPS, Barthel Index, Nosger), quality of life (Qualidem, Profile of Wellbeing), risk of falls (Tinetti), falls, cognition (Minimental Status Test), hospital admissions, medication use.

The results of this exploratory study are needed to plan a randomized controlled trial (RCT) with confirmatory design in the future.


Eligibility Criteria:
Inclusion Criteria:

* living in shared flat/residential community
* informed consent of patient or authorized representative

Exclusion Criteria:

* participation in another study within the last 6 months
* acute or chronic disease condition that does not allow participation
* actual use of complementary therapies
NMBA Reversal and Postoperative Urinary Retention

In this single-center retrospective cohort study of adult patients who underwent surgery under general anesthesia at Beth Israel Deaconess Medical Center between September 2016 and January 2024, the association between the choice of neuromuscular blocking agent (NMBA) reversal strategy, comparing sugammadex with neostigmine (combined with a muscarinic antagonist), and postoperative urinary retention (POUR) will be evaluated. In secondary analyses, the effects of NMBA reversal strategy and POUR on costs of care and unplanned hospital visits will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* Non-urinary system surgery
* General anesthesia
* Use of rocuronium or vecuronium for neuromuscular blockade
* Neuromuscular blockade reversal with sugammadex or neostigmine (with atropine and/or glycopyrrolate)
* Postoperative admission to the post-anesthesia care unit (PACU)

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status ≥ V
* Emergency reversal with sugammadex (≥ 16 mg/kg of sugammadex)
* Presence of foley or suprapubic catheter before or after the procedure
* Prior history of bladder resection surgery
* Observations with missing data for pre-specified confounding variables
Dysphagia and Cervical Spine Disorders in Patients With Brain Lesions

The research is about a prospective study conducted in patients suffering from dysphagia and cervical spine disorders and how they are interrelated. Three questionnaires have been given to patients with neurologic deficits, the first of these investigates the occurence of dysphagia in the three stages of swallowing, the second looks into the quality of life following a stroke or other neurologic damage and the third analyses how cervical spine disorders can affect every day life. After the bedside examination, VFSS or FEES, the patients are submitted to swallowing and cervical resistance exercises in fixed time periods after their hospitalisation. The results will be collected and evaluated using the statistical programme SPSS.


Eligibility Criteria:
Inclusion Criteria:

* brain lesions and cervical spine disorders

Exclusion Criteria:

* age
* peripheral damages
Connection Between Tongue Signs and Bile Reflux Analysed With Artificial Intelligence

By introducing artificial intelligence into Chinese medicine tongue diagnosis, we collated and collected tongue images, anxiety and depression scales and gastroscopy reports, mined and analysed the correlation between tongue images and bile reflux and anxiety and depression and constructed a prediction model to analyse the possibility of predicting bile reflux and anxiety and depression in patients based on tongue images.

Firstly, after the patient signs the informed consent form, the researcher will collect pictures of the patient's tongue and obtain basic information about the patient.

Second, the patients are scored on the Anxiety and Depression Scale.

Thirdly, after the patient undergoes gastroscopy, the patient's gastroscopy report is obtained.

Finally, the patient's tongue image, information and gastroscopy report are matched to construct an artificial intelligence model of tongue image and bile reflux and anxiety and depression, and the quality of the model is assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 80 years who wish to undergo gastroscopy.
* Patients have given their informed consent and signed the informed consent form.

Exclusion Criteria:

* Serious heart, liver, kidney or other underlying illness, or mental illness.
* Patients taking anti-anxiety or depression medication within 3 months.
* Current H. pylori infection.
* History of surgery on the digestive or biliary tract.
* Peptic ulcer, malignant tumour of the digestive tract, etc.
* Patients taking bismuth or other staining medications.
* Pregnant or lactating women.
LIquid Biopsy to prEdict Responses To First-line immunotherapY in Metastatic Non-small Cell LUNG Cancer. LIBERTY LUNG

Patient with histologically proven NSCLC in a metastatic stage, treatment naïve and eligible for first-line treatment with immune checkpoint inhibitor. Combination with chemotherapy is possible. Presence of a mutation after NGS analysis is required for ctDNA follow-up.

A pre-screening consent will be obtained for NGS analysis on tumor tissue. Only patients with at least 1 mutation at NGS on the tumor tissue will ultimately be enrolled in the study, to have the possibility to follow the mutation using ctDNA. Main consent will be obtained after results of the NGS and before initiation of pembrolizumab. Computed Tomography (CT)-scan imaging will be done every 9 weeks as part of routine care practice. Blood specimens will be taken with EDTA tubes or streck tubes at the time of puncture for pembrolizumab infusion at baseline before starting treatment, at 3 weeks, 6 weeks and then every 6 weeks. Blood immunomonitoring will be done before starting the treatment, at 6 weeks and at 18 week. An additional measurement will be performed if treatment is stopped before the end of the study.

- Optional blood samples will be realized to analyse the degree of activity of the plasmatic lymphocytes.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically-proven NSCLC.
2. Age ≥ 18 years.
3. Advanced or metastatic stage IV.
4. Treatment-naïve patient.
5. Eligibility to first-line treatment with immune checkpoint inhibitor.
6. Measurable disease according to RECIST 1.1 criteria on CT-Scan.
7. Availability of expression of PD-L1 at immunohistochemistry analysis of the tumor biopsy.
8. No ALK or EGFR gene alteration.
9. Availability of tumor tissue for NGS analysis (7 slides).
10. PS 0 or 1.
11. Signed informed consent of the patient.

Exclusion Criteria:

1. No social security affiliation.
2. Person under legal protection.
3. Pregnant and breastfeeding women.

Patients can participate to another clinical trial that is not modifying immunotherapy or immunotherapy/chemotherapy treatment nor study follow-up ; after investigator's information