cyrilzakka/clinical-trials huggingface dataset:
Reliability of a Body-worn Sensor System for Gait Analysis in Children With CP

Cerebral palsy (CP) is caused by a non-progressive injury in the developing brain, which leads to problems in functional mobility, posture, neuro musculoskeletal functions and gait. Around 75% of children with CP are ambulatory however they have gait problems such as excessive knee flexion, stiff knee, crouch gait or equinus which affects the quality of gait. When constructing an effective treatment plan in children with CP, a comprehensive assessment should be performed. One of the most essential assessments is gait analysis. Gait analysis is used in the quantitative assessment of gait disturbances providing functional diagnosis, assessment for treatment, planning, and monitoring of progress.

Gait analysis aims to determine the factors leading to gait disturbances. To reach this aim, a large amount of quantitative data concerning the gait characteristics of a patient is analyzed. The assessment of these data can be performed via standardized clinical videos, recorded with numerical video cameras used in conjunction with optical 3D systems. The purpose of this study was to confirm the test-retest reliability of a commercially available body-worn sensor- G-Walk® sensor system-for spatiotemporal gait parameters in children with CP.

The G-Walk determines spatiotemporal parameters as well as pelvic rotations during gait and allows objective and precise analysis of movements with its wearable inertial sensor. It also enables 3D kinematic analysis of the pelvis, providing a functional analysis of disorders in gait caused by neuromuscular diseases The device is placed on an elastic belt and worn on the waist of the person being evaluated, with the center of the device at the fifth lumbar vertebrae. To ensure correct placement of the device, the L4-L5 intervertebral space was palpated via the posterior superior iliac spines (SIPS).

After the accelerometer was placed, the children were asked to walk calmly at normal speed, on a 10 m track, whose boundaries were determined with colored lines and to return to the starting position.

The values and gait characteristics of acceleration in the anteroposterior (AP) and mediolateral (ML) axes were transferred to the computer software program.

The tilt of the pelvis in the sagittal plane in the flexion-extension direction, the oblique displacement in the coronal plane, the angles of the rotation of movement in the transverse plane and the symmetry values of the right and left sides are obtained. While the symmetry index ranges from 0 to 100, a value closer to 100 indicates that the gait is more symmetrical

Eligibility Criteria:
Inclusion Criteria:

* Accepting to participate in the study,
* Being between 5-15 years old,
* Having a diagnosis of Spastic Cerebral Palsy,
* Being level I-II according to GMFCS

Exclusion Criteria:

* Having limited cooperation which prevents participation in the study,
* Refusing to participate in the study,
* Having an orthopedic disorder or systemic illness which prevents movement in the lower extremities,
* Having a Botulinum toxin application in the last 3 month
St. Barbara Specialised Regional Hospital No. 5: Surveillance of Healthcare-Associated Infections

Retrospective laboratory-based data collection study of surgical site infections: Surveillance of Healthcare-Associated Infections in Orthopaedic and Trauma Surgery Unit in Sosnowiec, Poland;


Eligibility Criteria:
Inclusion Criteria:

* patient being treated in the Department and Clinic of Orthopaedic and Trauma Surgery, St. Barbara Specialised Regional Hospital No. 5, Sosnowiec
* patients undergoing surgery in studied unit

Exclusion Criteria:

* under 18 years of age
* surgery of a different type than orthopedics
* non-surgical treatment
Tools to Assess Medication Adherence

The issue of medication adherence (MA) has long been undestimated but is now growing interest due to both the increase of patients with chronic diseases and the aging of the population. According to the World Health Organization, only 50% of patients with chronic illnesses correctly follow physician's prescriptions in developed countries. Beyond the individual consequences that failure to adherence can engender (increased morbidity, mortality and hospitalizations), this concept also encompasses a collective dimension (risk of transmission of infectious diseases and increased health care costs). Today, improving MA would have more impact on human health than developping new medical therapies. That's why detecting non-adherence constitutes a major public health issue in which pharmacists play a significant role through medication reconciliation and patients' education.

The methods wildly used are based on indirect measurement: questionnaires completed by the patient himself or the Medication Possession Ratio (MPR). Each method has its own advantages and disadvantages, but none is considered as the gold standard. The Montpellier University Hospital set up a MA self-report scale ranging from 0 (low) to 10 (high adherence) in the various care units where the clinical pharmacy activity is deployed.

The purpose of this study was to assess the MA according to this numerical scale and the MPR calculation, and evaluate the correlation between these two methods.


Eligibility Criteria:
Inclusion criteria:

- Subjects aged over 18 years old, admitted in a care unit of Montpellier University Hospital where the clinical pharmacy activity is deployed

Exclusion criteria:

- Subjects without any medication therapy at home
Gabapentin Pretreatment for Staged Bilateral Cataract Operations

To evaluate the effect of oral gabapentin premedication on hyperalgesia in elderly patients undergoing staged bilateral cataract operations under monitored anesthesia care

It has been reported that patients with bilateral cataract complained more pain and discomfort during the second consecutive eye surgery compared to the first eye surgery.

Gabapentin is an anticonvulsant drug, which has been extended the use to perioperative analgesia, and anxiolysis.

Therefore, the investigators conducted this randomized, controlled study to evaluate the effects of gabapentin premedication on patients' subjective sensations, including intraoperative anxiety, perceptions of pain, and light sensitivity, in the second cataract operations.

Eligibility Criteria:
Inclusion Criteria:

* patients aged over 60 years, who undergoing staged bilateral cataract operations under monitored anesthesia care
* ASA physical status of I, II, and III

Exclusion Criteria:

* undergoing other eye operations together besides cataract operation
* patients with creatinin clearance lower than 30ml/min
* patients with CNS inhibitors medication
* patients with previous gabapentin medication
* pregnancy
The Coronavirus Impact Scale Validity and Reliability Study

This research; The Turkish validity and reliability study of the "Coronavirus Impact Scale" developed by Stoddard and Kaufman (2020) will be conducted in order to bring a new measurement tool to our country.

This research; The Turkish validity and reliability study of the "Coronavirus Impact Scale" developed by Stoddard and Kaufman (2020) will be conducted in order to bring a new measurement tool to our country.

Method: This research was planned as a methodological study. Research Question: Is the "Coronavirus Impact Scale" a valid and reliable measurement tool for Turkish society?

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old,
* At least primary school graduate,
* Able to communicate verbally and
* Persons who agree to participate in the research will be included in the research.

Exclusion Criteria:

* Psychiatric illness and unable to communicate,
* Having a language problem
* Persons who do not have the skills to read and understand the questionnaire will be excluded from the research.
Echocardiographic Assessment of Function During ECMO Support

The purpose of this study is to evaluate echocardiographic markers of cardiac function to assess the ability of patients to successfully end VA-ECMO support.

1. What is the major problem being addressed by this study?

   Extracorporeal membrane oxygenation (ECMO) is a machine used to do the work of the heart and lungs when children's hearts or lungs are too sick to perform normally. Veno-arterial (VA) ECMO therapy for poor heart function provides support that can lead to patient recovery, transplantation if appropriate and eligible, or complications of ECMO therapy lead to stopping care. Each day a patient is on ECMO, complications can occur that require stopping support, and attempting to get off ECMO as quickly as possible is important. There is currently no consistent way of assessing heart function while patients are supported by VA-ECMO to help guide when children's hearts have improved enough to survive without the help of ECMO.
2. What specific questions are you asking and how will you attempt to answer them?

The specific question we are asking is whether newer ultrasound measures of heart function can predict which patient may be well enough to be able to come off of ECMO support. We are following critically ill patients and performing multiple measurements at specific time points to look for changes in those patients whose heart function recovers and in those patients who do not recover function. The ultrasound measurements will be performed during changes in the amount of support provided by the ECMO machine.

* 3. What is the long-term biomedical significance of your work, particularly as it pertains to the cardiovascular area? What major therapeutic advance(s) do you anticipate that it will lead to? For instance, new drug(s), a surgical technique/procedure, a diagnostic tool/test, a previously undetected risk factor, etc.

Our long term goal is to develop non-invasive, quantitative measures of cardiac function for patients needing ECMO support to help guide care. Ultimately if deemed successful, these measurements could be used by all physicians who care for these patients. This study could lead to more efficient prediction of who needs to stay on ECMO and who could be removed. This could help to improve survival and decrease complications in some of the sickest children. These measurements may also help us to identify, at an early stage, those patients whose hearts are too sick to recover and will need a heart transplant evaluation.

Eligibility Criteria:
Inclusion Criteria:

* VA ECMO (all cannulation sites)
* Primary Cardiac Failure
* Septic Shock

Exclusion Criteria:

* VV ECMO
* Primary Respiratory Failure
* Congenital Diaphragmatic Hernia
* Persistent pulmonary hypertension of the newborn
* greater than 1 source of systemic perfusion
Testing a Medication Risk Communication and Surveillance Strategy: The EMC2 Trial

This study evaluates the effectiveness of an electronic health record based educational intervention (the EMC2 strategy) to improve patient understanding and use of higher-risk medications. Half of the participants will receive the intervention, while the other half will receive the usual amount of information (usual care).

Research has repeatedly demonstrated that individuals lack essential information on how to safely take prescribed (Rx) medications. A risk communication and surveillance strategy is needed in primary care to ensure that patients are adequately informed about medication risks and are taking prescribed regimens safely.

The investigators devised an Electronic health record-based Medication Complete Communication (EMC2) Strategy that leverages electronic health record (EHR) and interactive voice response (IVR) technologies to:

1. prompt and guide provider counseling,
2. automate the delivery of Medication Guides at prescribing,
3. follow patients post-visit to confirm prescription understanding and use, and
4. deliver a care alert back to providers to inform them of any potential harms.

Eligibility Criteria:
Inclusion Criteria:

* 21 and older
* English or spanish speaking
* Primarily responsible for administering own medications
* New prescription of one of 66 study medications on day of recruitment
* Has a personal mobile or land line phone

Exclusion Criteria:

* Severe, uncorrectable vision
* Hearing or cognitive impairments
A National Registry For Patients With Hidradenitis Suppurativa

The goal of this study is to get a better understanding of the skin condition, Hidradenitis Suppurativa, and to find out how the disease affects quality of life. The investigators hope this information will help improve treatment for this skin condition.

The goal of this study is to get a better understanding of the skin condition, Hidradenitis Suppurativa, and to find out how the disease affects quality of life. The investigators will utilize a compilation of validated questionnaires including the Beck Depression Inventory form, Dermatology Life Quality Index (DLQI), Skindex, SF-36 health survey, the Quality of Life Enjoyment and Satisfaction Questionnaire- short form (Q-LES-Q-SF) and the Employment/Productivity Health Economic Questionnaire as well as other relevant clinical data. The investigators will additionally collect a modified Hidradenitis Suppurativa Lesion, Area, and Severity Index (HS-LASI) (or other appropriate disease severity score as determined by the team) from the physician of each enrollee. The investigators hope this information will help improve treatment for this skin condition.

Eligibility Criteria:
Inclusion Criteria:

* Subjects 18-99 years of age who have a diagnosis of Hidradenitis Suppurativa (as deemed by a physician at the Montefiore Hidradenitis Suppurativa Treatment Center)

Exclusion Criteria:

* Patients without a diagnosis of Hidradenitis Suppurativa or under the age of 18
* Patients who are unable to answer given questions within the 6 surveys
* Patient who are unable to be clinically evaluated by a Montefiore physician
Immersive Virtual Reality in Orthopedics

Interventions may be a particular source of anxiety for some patients, and the management of surgical pain is still a real challenge. In order to avoid the side effects of medications, a lot of caregivers are turning to complementary medicines.

The prosthetic knee surgeries are painful and anxiety-provoking acts. At the hospital of Montauban, to relieve patients' pain, we offer them a therapeutic regimen with regional anesthesia (spinal anesthesia). We also use accompaniment hypnotic virtual reality to the management of anxiety and pain patients.

Interventions may be a particular source of anxiety for some patients, and the management of surgical pain is still a real challenge. In order to avoid the side effects of medications, a lot of caregivers are turning to complementary medicines.

The prosthetic knee surgeries are painful and anxiety-provoking acts. At the hospital of Montauban, to relieve patients' pain, we offer them a therapeutic regimen with regional anesthesia (spinal anesthesia). We also use accompaniment hypnotic virtual reality to the management of anxiety and pain patients.

Despite a high level of approval of patients (according our satisfaction surveys) concerning hypnotic virtual reality, we want to evaluate our practice. Thus, in the future, we can invest in this type of material and make it available to a larger number of patients, but only if complementary care proves its effectiveness.

The purpose of this study is to evaluate the effectiveness of hypnotic virtual reality support on the patient's state of anxiety before and after prosthetic knee surgeries under spinal anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients for prosthetic knee surgery under spinal anesthesia
* Patient who has received appropriate information and has provided informed consent
* Patient with French social security system

Exclusion Criteria:

* Patient under general anaesthesia
* Patients treated in conventional inpatient care or in the traditional ambulatory circuit
* Patient under guardianship or trusteeship
* Minor patient \< 18 years of age
* Patient who has not provided informed consent or who cannot submit to the study protocol
* Patient suffering from cognitive disorders (ex: Alzheimer's disease)
* Patients who are deaf or hearing-impaired or epilepsy
* Infected patient or identified as carrier of an infectious agent
Stem Cell Related Donor Safety Study

The study tests the hypothesis that related hematopoietic stem cell donors are at a higher risk for acute medical and psychological toxicity associated with the donation process compared to adult unrelated hematopoietic stem cell donors.

The study will also assess the hypothesis that young (\<18 years) and older (\>60 years) related donors are at increased risk for toxicity associated with donation compared to younger adult donors by describing the adverse events reported in these populations.

An ancillary study of the psychological impact of donation on health-related quality of life (HRQoL) will enroll related donors and compare them to an age-matched normative cohort.


Eligibility Criteria:
Inclusion Criteria:

* Donors of any age providing either a first or second BM or PBSC donation
* Meet donation criteria per institution policies and procedures
* Willing to receive phone follow-up at 1, 6, and 12 months
* Signed informed consent for study participation

For the HRQoL ancillary study, inclusion criteria:

* Related donors age greater than or equal to 5, eligible and consented to the primary trial by the above listed inclusion criteria
* Donors competent to answer psychological assessment questions by themselves, or if a child, should be able to respond to psychological assessment questions and have an appropriate proxy also able to complete the HRQoL proxy interview
* English speaking
* Access to a telephone
* Willing to participate in pre-donation, 1 month and 1 year follow-up interviews
* Signed informed consent for study participation in ancillary study

Exclusion Criteria:

* Per institutional guidelines
* Donors providing unstimulated peripheral blood stem cells or lymphocytes

For the HRQoL ancillary study, exclusion criteria:

* Children less than or equal to 4 years of age
A Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ABT-333

The purpose of this study is to determine multiple dose safety, tolerability and pharmacokinetics of ABT-333 under nonfasting conditions in healthy adult subjects, and to determine the effect of single dose administration of ketoconazole on steady state ABT-333 pharmacokinetics

Phase 1, Blinded, Randomized, Placebo-controlled Study in Healthy Adult Subjects to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Multiple Doses of ABT-333

Eligibility Criteria:
Inclusion Criteria:

* Main Selection Criteria for Healthy Volunteers:

  * Subject has provided written consent.
  * Subject is in general good health.
* If female, subject is postmenopausal for at least 2 years or surgically sterile.
* If female, subject is not pregnant and is not breast-feeding.
* Male or female between 18 and 55 years old, inclusive.
* If male, subject must be surgically sterile or practicing at least 1 method of birth control.
* Body Mass Index (BMI) is 18 to 29, inclusive.

Exclusion Criteria:

* See above for main selection criteria
Molecular Profiling of Advanced Biliary Tract Cancers

Biliary tract cancer (BTC) accounts for \<1% of all cancers, but remains a highly fatal malignancy. Surgical resection is the only hope for cure, but most patients present with advanced disease when curative-intent surgery is not possible. The therapeutic options for patients with advanced disease are limited, primarily to chemotherapeutic regimens, which are based on empiric evidence without the use of biomarkers. These current treatment strategies have been largely ineffective in controlling the disease, resulting in poor survival outcomes of less than 1 year. An understanding of the molecular characteristics of biliary tract cancer may enable stratification of patients into therapies that target specific molecular alterations with greater efficacies and improved clinical outcomes. This study aims to investigate the feasibility and clinical utility of prospective molecular profiling of advanced biliary tract cancer. The primary endpoint of this study is to demonstrate the feasibility of returning whole genome sequencing results within 8 weeks of tumour biopsy for second-line treatment consideration (n=30 patients). In parallel, tumour whole transcriptome sequencing will be performed to identify actionable molecular alterations (e.g., fusion transcripts). Once the primary endpoint is met, the study will be expanded. Current funding allows expansion to 40 patients in total.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have a histological or radiological diagnosis of inoperable or metastatic BTC.
* Patient must have a tumour that is amenable to a core needle biopsy.
* Patients must have a measurable lesion by RECIST 1.1 in addition to the lesion that is going to be biopsied.
* Patients must be fit to safely undergo a tumour biopsy as judged by the investigator.
* Eastern Cooperative Group (ECOG) performance status ≤ 1.
* Life expectancy of greater than 90 days.
* Within 14 days of the proposed biopsy date, patients must have normal organ and marrow function.
* Patients must undergo systemic treatment with gemcitabine-based regimens as first-line standard systemic palliative treatment with or without other investigational agents within a clinical trial.
* Ability to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Patients with one or more contraindications to tumour biopsy.
* Patients who have had any prior chemotherapy or other anti-cancer agent in the advanced stage setting.
* Patients who are currently on anti-cancer treatment.
* Patients with known brain metastases.
* Uncontrolled concurrent illness that would limit compliance with study requirements.
* Any other condition that would contraindicate the patient's participation due to safety concerns or compliance with clinical study procedures.
PEACe: Ivy, Thyme and Cisti Extract (Phytus) Efficacy in Acute Cough

The purpose of this study is to investigate the efficacy of Phytus in Acute Cough

Common colds are the most frequently encountered human diseases worldwide. Common cold is a conventional term used for mild upper respiratory illnesses, which comprises a heterogeneous group of self-limited diseases caused by numerous viruses. The frequency is age-specific with fewer episodes in adults than in younger children. Cough due to the common cold is probably the most common cause of acute cough. In a significant subset of patients with "post infectious" cough, the etiology is probably an inflammatory response triggered by a viral upper respiratory infection (ie, the common cold). The resultant sub-acute or chronic cough can be considered to be due to an upper airway cough syndrome, previously referred to as postnasal drip syndrome.

Thyme leaf (Thymus vulgaris) expels phlegm and relieves congestion . It is antiseptic and an immune stimulant. The primary chemical constituents of Thyme include essential oil (borneol, carvacrol, cymol, linalool, thymol), bitter principle, tannin, flavonoids (apigenin, luteolin), saponins, and triterpenic acids. Thyme warms and stimulates the lungs, expels mucus, and relieves congestion. It also helps deter bacterial, fungal, and viral infections. The thymol content of thyme works as an expectorant and cough suppressant and is frequently used in cough syrups.

Eligibility Criteria:
Inclusion Criteria:

* Cough attributed to URTI such as the common cold
* Moderate to severe day cough according to questionnaire (score at least 3 on all 3 questions relating to day cough) considering the day prior to enrollment.
* Moderate to severe night cough score according to questionnaire (score at least 3 of 2 of the three questions relating to the evaluation of nocturnal cough

Exclusion Criteria:

* Diagnosis of chronic cardiac condition, or cystic fibrosis or any anatomical respiratory tract anomalies,
* Received antihistamines or any cough medicine the day prior to study entry,Known sensitivity to any component of Phytus