cyrilzakka/clinical-trials huggingface dataset:
Trunk Balance and Functional Independence in Individuals with SCI

This study investigates the relationship between trunk balance, position sense, wheelchair skills, and functional independence in individuals with thoracic spinal cord injury. It aims to understand how these factors interact and influence daily activities and overall quality of life.

Sitting balance and wheelchair transfer activities are crucial for non-ambulatory spinal cord injury (SCI) patients to be able to perform activities of daily living. In addition, a comprehensive assessment of trunk balance is recommended in the literature to predict the risk of falls in these patients and to determine their functional independence. However, no study was found in the literature that included only patients with thoracic level involvement in terms of parameters such as trunk balance, fall risk, postural control abilities, functional activity and independence, which are closely related to the level of injury in patients with SCI. There is a need for a comprehensive evaluation of the patient in terms of trunk control and trunk balance, especially after a SCI defined in the thoracic segment of the medulla spinalis. In this study, male and female individuals between the ages of 18-65 years with SCI with thoracic level involvement who continue their routine treatment at the Neurological Rehabilitation Unit of Afyonkarahisar University of Health Sciences Health Application Center Department of Physical Therapy and Rehabilitation will be included. The aim of the study is to examine the relationship between trunk balance, trunk position sense, wheelchair skills and functional independence status of the participants. The findings to be obtained after the study will be analyzed in patients with SCI at the thoracic level.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with traumatic or nontraumatic spinal cord injury,
* Having a thoracic injury level (T1-T12),
* At least 6 months have passed since the SKY injury,
* To have 90 degrees of shoulder flexion and abduction in both upper extremities,
* Be over 18 years of age,
* To be able to sit in a wheelchair without support and use a manual wheelchair independently,
* Volunteering to participate in the study.

Exclusion Criteria:

* Having a systemic disease,
* Report a diagnosis of cardiovascular disease,
* Report musculoskeletal pain or pathology involving the upper extremity,
* Patients with intracardiac defibrillators,
* Presence of open wound.
Quality of Life Change in Patients Undergoing Parathyroidectomy With End-stage Renal Failure

The purpose of this study is to characterize the quality of life change in patients undergoing parathyroidectomy with secondary hyperparathyroidism due to end-stage renal failure.

Study participants will be asked questions about age, gender, education level, clinical symptoms, intensities of depression and anxiety, etc, and they will also be questioned regarding the prior quality of life score, as measured by the health-related quality of life 36-item Short-Form (SF-36) survey before surgery. Then, study participants will be contacted at one, three, six months, and 1 year after surgery, and asked questions about their SF-36 score, depression, and anxiety intensity.

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥18 years old;
* Patients scheduled for parathyroidectomy with secondary hyperparathyroidism due to end-stage renal failure

Exclusion Criteria:

• Patients refuse to participate
Assessment of Hematologic Parameters Before and After Bimaxillary Orthognathic Surgery

The purpose of the present study was to compare some hematologic parameters and operation time in patients who underwent esthetic bimaxillary surgery under hypotensive anesthesia.

Patients who underwent bimaxillary surgery were prospectively evaluated. Patients were divided into groups based on the surgical procedure and sex (predictor variables). Hemoglobin, red blood cells, hematocrit, and platelet were the primary outcome variables, operation time was the secondary outcome variable, and the patients' age and weight were the other variables.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients listed for elective bimaxillary osteotomies for orthognathic correction by one surgical team, and admitted from August 2010 until June 2012.

Exclusion Criteria:

* Patients who were having single maxillary osteotomies, Le Fort II and III osteotomies, those with general contraindications for extensive surgical intervention, syndromic patients, those with cleft palate, and those with general diseases or hematological disorders.
Continuous Endotracheal Cuff Pressure Control to Prevent Ventilator Associated Respiratory Infections

The purpose of the study is to determine whether automated cuff pressure control results in a reduction in the proportion of patients developing ventilator associated respiratory infections during their stay in intensive care.

The proposed study is a randomized controlled trial of tracheal cuff pressure control using continuous control via an automated electronic device as compared with intermittent pressure control for the prevention of ventilator associated respiratory infection in ICU.

The study will be conducted at multiple sites in Vietnam. Recruitment will be for 18 months at all centers. Patients experiencing any hospital acquired infection whilst at risk of Ventilator Associated Respiratory Infections will be evaluated in using a standardised investigation protocol to identify cases of VARI and other hospital acquired infections (HAI)s. Assessment of VARI will be based on published criteria and carried out by an endpoint review committee independent of patient care and blinded to the allocation of the patient. Antibiotic use data and duration of stay will be important secondary outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* About to be intubated or intubated for ≤ 24 hours (either oral or tracheostomy)
* For active treatment

Exclusion Criteria:

* previously enrolled in this study
* previously intubated within 14 days
* suffering from known tracheomalacia, tracheal stenosis or stridor relating to tracheal injury
Improvement of Peritoneal Catheter Placement in VPS With a Splitable Trocar

This study is a phase I/IIa, single-center, open-labeled, randomized, controlled clinical trial. The aim of this study is to evaluate the safety and efficacy of a modified ventriculoperitoneal catheter placement using a splitable trocar for ventriculoperitoneal shunt.

This study is a phase I/IIa, single-center, open-labeled, randomized, controlled clinical trial. Patients hospitalized with hydrocephalus will be enrolled and randomly allocated into open mini-laparotomy group (OLG) or abdominal puncture group (APG) for insertion of the peritoneal catheter. Observe will followed for up to at least 6 months after surgery. The primary endpoint is the rate of overall shunt complication or failure within the first 6 months after surgery, and duration of the abdominal catheterization. The secondary endpoints are rate of distal shunt failure, the overall incidence of various adverse reactions, abdominal incision size, analgesic use as evaluated on Day 5 postoperatively, duration of hospital stay. Moreover, neurological function of patients (mRS, maxillary hydrocephalus scale) and CT measurement of Even index will also be evaluated.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 years or older with new-onset hydrocephalus, including obstructive hydrocephalus, traffic hydrocephalus and special types of hydrocephalus, normal pressure hydrocephalus (NPH), idiopathic intracranial hypertension (IIH), benign intracranial hypertension, pseudotumor cerebri, etc., regardless of gender.
2. Initial diagnosis of hydrocephalus requiring ventriculoperitoneal shunt or shunt failure requiring secondary surgery to replace the shunt.
3. Provided written informed consent.

Exclusion Criteria:

1. Previous abdominal surgery (except ventriculoperitoneal shunt).
2. Pregnancy
3. Peritonitis
4. Patients with cognitive impairment and inability to communicate.
5. Expected survival less than 6 months
Music During Diagnostic Hysteroscopy

Office Hysteroscopy is associated with a level of anxiety that could condition tolerability of the procedure by the patient.

The aim of this study is to evaluate the impact of music on anxiety state, expected and received pain by patients during office hysteroscopy.


Eligibility Criteria:
Inclusion Criteria:

* Patients candidates for office hysteroscopy in menopausal status or in childbearing age

Exclusion Criteria:

* Previous diagnostic hysteroscopy and/or RCU
* Current or recent pelvic Inflammation
* Invasive cervix cancer
* Ongoing pregnancy
Interaction Between Smoking, GCF Periostin, IL17A, IL17E and Non-surgical Periodontal Therapy

It was aimed to evaluate the changes in the levels of Periostin, IL-17A and IL-17E cytokines in the gingival crevicular fluid (GCF) of periodontitis patients which non-surgical (Phase I) periodontal treatment applied to and their interactions with smoking. The study included systemic healthy smokers(SP)(n:11) and non-smokers(P)(n:11) with periodontitis, smokers (SS)(n:11) and non-smokers(S)(n:11) with periodontal healthy individuals Phase I periodontal treatment was applied to the groups with periodontitis. Before treatment (day 0), clinical measurements evaluating periodontal status were recorded and GCF samples were collected. GCF samples were collected from the same tooth regions on the 15th and 30th days after treatment and clinical measurements were repeated. GCF Periostin, IL-17A and IL-17E levels were determined by ELISA method. All data were evaluated statistically.

The SH and H groups' patients were instructed to visit for routine controls without receiving any periodontal treatment. However, after the GCF sampling, patients in the SP and P groups received Non-surgical periodontal treatment(NSPT) included detailed oral hygiene instruction and reinforcement in conjunction with scaling and root planning as a full mouth debridement protocol in a single session They were instructed to refrain from using any chemicals, including mouthwash, to remove plaque.

The periodontitis patients received a follow-up call on the 15th and 30th days following treatment. The GCF sampling procedure was first repeated on the teeth from which a previous GCF sample had been taken. Then, values for the clinical examination parameters (PI, GI, BOP, PD, and CAL) were once again measured and recorded. Daily plaque care efficacy or deficiency was checked and/or reinforced at every recall. All these procedures were performed by a single investigator.

Eligibility Criteria:
Inclusion Criteria:

* generalized stage 3 periodontitis or periodontally healthy;
* smoker ((≥10 cigarettes/day for \>5 years) or nonsmoker (never smoked in their lifetime);
* not have received any periodontal treatment in the last 6 months, took any antibiotics, anti-inflammatory drugs regularly and for female subjects, not to be pregnant, lactating, or menopause.

Exclusion Criteria:

* Under 18 years of age
* Those with a systemic disease
* Cancer patients, those with a history of chemotherapy and radiotherapy
* Pregnant and breastfeeding women
* Those who smoke less than 10 cigarettes a day and those who quit smoking
* Having received orthodontic treatment in the last 6 months
* Using antibiotics, anti-inflammatory or any medication in the last 6 months
* Those who do not consent voluntarily
Hip Abductor Function During Trendelenburg Test

This study will use electromyography and dynamometry to evaluate gluteal muscle activation during the Trendelenburg hip abduction test in different hip positions.

The Trendelenburg test is commonly used to assess hip abductor weakness. However, it is unclear which hip position during this test best isolates gluteal muscle function. This study will measure gluteus medius and minimus activation and hip abduction force in 30 healthy participants performing the Trendelenburg test. Different hip flexion, extension, adduction and abduction angles will be evaluated to determine which position optimally targets the gluteal muscles. Results may enhance utilization of the Trendelenburg test in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 18-45 years
* No history of hip disorders

Exclusion Criteria:

* Contraindications to EMG
* Neurological or muscular disorders
Daily Wear Comparison of Enhanced and Non-Enhanced Silicone Hydrogel Lenses

The purpose of this study is to compare an experimental contact lens with a currently marketed contact lens.


Eligibility Criteria:
Inclusion Criteria:

* Able to wear contact lenses for a minimum of 5 days a week, at least 8 hours a day
* On exam have ocular findings that are considered normal and would not prevent the safe wear of contact lenses
* Other protocol-defined inclusion/exclusion criteria may apply

Exclusion Criteria:

* Requires concurrent ocular medication
* Eye injury or surgery within twelve weeks immediately prior to enrollment
* Evidence of systemic or ocular abnormality, infection, or disease likely to affect successful wear of contact lenses or use of their accessory solutions
* Any active corneal infection
* Any use of medications for which contact lens wear would be contraindicated
* History of corneal refractive surgery
* Wears toric contact lenses
* Other protocol-defined inclusion/exclusion criteria may apply
Acute Oral Ketones or Carbohydrate Supplement Modify Heart Function in Heart Failure?

Does oral intake of exogenous ketone salt improve heart function measured by cardiac MRI in heart failure compared to oral intake of a carbohydrate placebo?

This study will help to quantify heart and kidney ketone uptake with or without an exogenous ketone salt in heart failure condition.

Participants will have 2 different cardiac MRI to perform:

1. Fasting with exogenous ketone salt supplement
2. Fasting with exogenous carbohydrate supplement

Eligibility Criteria:
Inclusion Criteria:

* Patients with heart failure with left ventricle ejection fraction of 40%
* Heart failure of ischemic or dilated etiology
* Ambulatory patient with a NYHA functional class of II-III;
* Stable symptoms and no change in medical therapy in the last month.

Exclusion Criteria:

* Diabetes
* Patients treated with any SGLT2i;
* Chronic kidney disease
* Acute coronary syndrome in the last 3 months;
* Use of parenteral inotropic agents;
* Persistent or permanent atrial fibrillation or atrial flutter;
* Presence of pacemaker or defibrillator;
* Medical condition that causes malabsorption of the test material;
* Under ketogenic diet, or using exogenous ketone supplements
* Use of nicotinamide adenine dinucleotide (NAD) precursor supplements
Assessment of Autonomic Regulation During the Listening of Mother Heart Beat in Newborns

Prematurity birth lead to an early breaking link with the in utero environment. A special attention is brought in the neonatal intensive care units to reduce noise and lighting surrounding aiming to protect the newborn.

During the uterine life fetus benefits previously of several auditory stimulations by the maternal voice, the mother's heartbeat. After birth the auditory environment is dramatically modified.

Aim of this study is to submit to the newborn an audio recording of his mother's heart beat to analyze the comfort, stress and autonomic response. Heart rate variability (HRV) analysis is a non-invasive tool able to consider autonomic nervous system activity. Previous studies have shown that pleasant feelings are associated with an increase of high frequencies variations index (HFnu index) reflecting a prevalence of parasympathetic activity in the sympathetic-parasympathetic balance. This one can be simply assess by a monitor named NIPΣ and can provide a comfort index by quantifying the parasympathetic tone.

The study will imply 40 preterm and term newborns hospitalized in neonatal intensive care units of the University Hospital of Saint-Etienne (France).

Eligibility Criteria:
Inclusion Criteria:

* Neonates between 28 and 40 Weeks of Gestational Age (wGA)
* Hospitalized in the neonatal intensive care units of the university hospital of Saint-Etienne (France)

Exclusion Criteria:

* Respiratory or hemodynamic instability
* Uncontrolled sepsis
* Sedation on going
* Treatment known to modify the sympathetic or parasympathetic activity of the autonomic nervous system
* Congenital disease
* Congenital ear pathology
A Study of Multi-electrode Circular Irreversible Electroporation (IRE) Catheter and Multi-Channel IRE Generator in Paroxysmal Atrial Fibrillation (AF)

The purpose of this study is to evaluate the long term off-Antiarrhythmic Drug (AAD) effectiveness of Biosense Webster, Inc. Irreversible Electroporation (BWI IRE) system in treatment of participants with symptomatic drug refractory paroxysmal atrial fibrillation (PAF).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with symptomatic paroxysmal atrial fibrillation (PAF) (Physician's note indicating recurrent self-terminating atrial fibrillation \[AF\]). At least one electrocardiographically documented AF episode within twelve (12) months prior to enrollment. Electrocardiographic documentation may include, but is not limited to, electrocardiogram (ECG), Holter monitor, or telemetry strip
* Failed at least one Class I or Class III antiarrhythmic drug (AAD) as evidenced by recurrent symptomatic AF, contraindicated or intolerable to both Class I and Class III AAD
* Able and willing to comply with all pre-procedure, post-procedure, and follow-up testing and visit requirements
* Willing and capable of providing consent

Exclusion Criteria:

* AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause (Example, untreated documented obstructive sleep apnea and acute alcohol toxicity)
* Previous left atrium (LA) ablation or surgery
* Participants known to require ablation outside the pulmonary vein (PV) region (atrioventricular reentrant tachycardia, atrioventricular nodal reentry tachycardia, atrial tachycardia, atrial flutter of unknown origin, ventricular tachycardia and Wolff-Parkinson-White)
* Previously diagnosed with persistent AF (greater than \[\>\] 7 days in duration)
* Severe dilatation of the LA (documented LAD \>50 millimeters \[mm\] antero-posterior diameter by transthoracic echocardiography (TTE) within 6 month prior to enrollment)
Evaluation of Immunological, Microbiological and Metabolomic Profiles in COPD

COPD is a significant health problem worldwide. It affects more than 10% of patients over the age of 40. According to the World Health Organization, it is the third most common cause of death among adults in the world, and the number of patients is continuously growing. Hence, all measures aimed at a better understanding of COPD pathogenesis, the course of the disease, and limitations in treatment efficacy seem critically important. Since 2008 our team has provided a substantial output in understanding the pathophysiology of airway inflammation in obstructive lung diseases. In our studies, we systematically evaluated selected cytokines concentrations in different respiratory samples to determine their mutual relations and to determine the role of cytokines in airway inflammation more precisely. However, there is still a large gap in our understanding of COPD. It is hypothesized that in COPD pathogenesis, additional factors, like genetics, autoimmune processes or deviated microbiota are involved. Each of the mentioned factors leads to a different type of immune response with a different effect on the airways. We believe that using more advanced laboratory methods (i.e. metabolomics and airway microbiome analysis) alongside the well-established ones (i.e. cellular and cytokine composition) will allow for an adequate characterization of inflammation.

The study will include 50 COPD subjects and 50 smokers without COPD and 20 control subjects (never smokers) who meet the inclusion and exclusion criteria (Table 1) and give an informed written consent to participate in the study. All study participants will undergo the following procedures: peripheral blood sample collection, chest HRCT imaging (without contrast), lung function assessment (spirometry with a bronchial obstruction reversibility test, bodyplethismography, diffusion lung capacity for carbon monoxide (DLCO), sputum induction with sterile hypertonic saline (NaCl).


Eligibility Criteria:
Inclusion Criteria:

* age ⩾ 40 years,
* written informed history of smoking ⩾ 10 pack-years
* COPD diagnosis (post- bronchodilator FEV1/FVC \< LLN)
* stable COPD (min. 3 months)

Exclusion Criteria:

* history of asthma or current lung disease (exception: solitary nodules), respiratory failure
* use of inhaled or oral steroids in the 3 months prior to the study,
* infection of the respiratory tract or exacerbation in the 3 months prior the study
* uncontrolled comorbidities such as: systemic connective tissue diseases, malignancy, uncontrolled cardiovascular diseases, chronic paranasal sinusitis,
* contraindications to sputum induction
Massive Mental Health Screening Using Smartphones in 24 Pre-graduate Education Centers in Mexico City: TEDUCA Survey Protocol

The objective of this study is to make a massive suicide risk and social behavior assessment in 24 pre-graduate education centers in Mexico City (approximately 30,000 students aged between 15 and 22 years), taking also into account other outcomes such as depression, anxiety, alcohol and drugs. For this, an app for Smartphone (MeMind) or a web platform (www.MeMind.net) will be used in which the participants will take a self-administered questionnaire, composed of several psychometric instruments.

Our main hypothesis is that identification of suicide risk in the Mexico City's student community is feasible using their own smartphones and can serve as both a population screening tool for early specialist referral, as well as a tool for evaluating social behavior strategies and their relation to suicide behavior.


Eligibility Criteria:
Inclusion Criteria:

1. Use a smartphone as personal or computer terminals enabled by the municipality of Milpa Alta or educational services.
2. Be able to understand the nature, purpose and methodology of the study.
3. Accept participation in the study and check the corresponding box in the app to verify that the informed consent has been expressly given.

Exclusion Criteria:

1. Subject deprived of liberty (by judicial or administrative decision)
2. Subject protected by law (guardianship or conservatorship)