cyrilzakka/clinical-trials huggingface dataset:
Reducing Rate of Falls in Older People by Means of Vestibular Rehabilitation: Preliminary Study

The aim of this study is to evaluate the effectiveness of vestibular rehabilitation to improve the balance in older people and reduce the number of falls, comparing three arms with different vestibular rehabilitation strategies (dynamic posturography exercises, optokinetic stimuli and exercises at home) and a control group.

Vestibular rehabilitation has been shown to be effective in compensating patients with residual instability as a result of vestibular system disorders or Parkinson's disease. It is also useful for treating lack of balance in the elderly (presbivertigo). However, there is no systematic, controlled and prospective analysis of whether vestibular rehabilitation is effective in reducing the number of falls in the elderly, or whether its effects in this age group are temporary or persist over time.

This study compare vestibular rehabilitation with three different strategies (dynamic posturography exercises, optokinetic stimuli and exercises at home) and a control group, in people over 65 years. Balance tests are performed before vestibular rehabilitation and three weeks, six months and one year after it. Number of falls are quantified one year after vestibular rehabilitation.

Eligibility Criteria:
Inclusion Criteria:

Persons with a high risk of falling shall meet at least one of the following requirements:

* Having fallen at least once in the last 12 months.
* Using more than 15 seconds or needing support in the TUG test (normal limit calculated in previous studies).
* Obtaining a mean CDP SOT balance score of \< 68% (normal limit calculated in previous studies).
* Having fallen at least once in the CDP SOT.

Exclusion Criteria:

* Cognitive decline that prevents the patient from understanding the examinations and vestibular rehabilitation exercises.
* Organic conditions that prevent standing on two feet, necessary for assessment of balance and performance of vestibular rehabilitation exercises.
* Balance disorders caused by conditions other than age (neurologic, vestibular...).
* Reduced cultural level that prevents the patient from understanding the examinations and from granting informed consent.
Serum Pentraxin-3 in Non-alcoholic Fatty Liver Disease With or Without Hepatitis C Virus

This study included 70 subjects divided into 3 groups. Group I included 25 patients with NAFLD. Group II included 25 patients with NAFLD and chronic HCV. Group III: included 20 controls. Abdominal ultrasound was done to patients and controls. Plasma pentraxin-3 (PTX3) was measured using ELISA. Comparison between three groups was done regarding plasma pentraxin-3. Higher levels of plasma PTX3 were detected in NAFLD patients irrespective of presence or absence of chronic HCV infection. Plasma PTX3 could be used as a non-invasive test for prediction of metabolic syndrome in the high-risk population with high sensitivity and moderate specificity.


Eligibility Criteria:
Inclusion Criteria:

* Patients with NAFLD.
* Patients with NAFLD and chronic hepatitis C viral infection.

Exclusion Criteria:

* Current or past consumption of significant amount of alcohol more than 21 drinks and 14 drinks per week for men and women respectively.
* Patients receiving Drugs which cause fatty liver as amiodarone, diliazem, tamoxifen, steroids.
* Patients who take statins as it has lowering effect on plasma PTX3.
* Patients having any clinical evidence of hepatic decompensation, such as hepatic encephalopathy, ascites, variceal bleeding, elevated serum bilirubin level to more than two folds the upper limit of normal.
* Patients with heart failure.
* Patients with autoimmune rheumatic disease.
* Patients with chronic kidney diseases.
* Patients with sepsis.
Clinical Study on the Safety and Efficacy of CD7 CAR-T Cell Sequential Allo-HSCT and Kidney Transplantation in the Treatment of SIOD

A Clinical Study on the Safety and Effectiveness of CD7 CAR-T Cell Sequential Allo-HSCT and Kidney Transplantation in the treatment of Schimke immuno-osseous dysplasia

This is a single-arm, open-label, dose-escalation clinical trial to evaluate the safety and efficacy of CD7 CAR-T Cell Sequential Allo-HSCT and Kidney Transplantation in patients with Schimke immuno-osseous dysplasia. It is planned to enroll 20 participants in this trial.

Eligibility Criteria:
Inclusion Criteria:

* 1. Diagnosed as SIOD and was in stage 5 of chronic kidney disease
* 2. Having allogeneic HSCT indications, at least suitable donors (relatives) for haploidentical allogeneic transplantation and kidneys from stem cell transplantation donors;
* 3. serum total bilirubin ≤ 1.5 times the upper limit of normal, and serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were both ≤ 3 times the upper limit of the normal range.
* 4. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
* 5. There is no active pulmonary infection, and the oxygen saturation during air inhalation is more than 92%；
* 6. Estimated survival time ≥ 3 months;
* 7. ECOG performance status 0 to 1;
* 8. Pregnant/lactating women, or male or female patients who have fertility and are willing to take effective contraceptive measures at least 6 months after the last cell infusion during the study period;
* 9. Those who voluntarily participated in this trial and provided informed consent;

Exclusion Criteria:

* 1. Allergic to pretreatment measures
* 2. received any containing ATG/ALG such IST、alemtuzumab、high-dose cyclophosphamide (≥ 45mg/kg/day) , received CsA treatment within 6 months, or used thrombopoietin receptor (tpo-r) agonists in the past;
* 3. Patients with the history of epilepsy or other CNS disease;
* 4. Patients with prolonged QT interval time or severe heart disease;
* 5. Previous recipients of allogeneic hematopoietic stem cell transplantation or organ transplantation
* 6. People infected with HIV, active hepatitis B or hepatitis C virus, and patients with active infection who are not cured;
* 7. The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal;
* 8. Patients with malignant tumor;
* 9. People with other genetic diseases；
* 10. After receiving CD7 car-t treatment, patients who were unable to accept subsequent kidney transplantation due to severe infection or poor amplification of car-t in vivo.
* 11. Any situation that researchers believe may increase the risk to the subjects or interfere with the trial results.
Utilization of Target Ranges to Treat Persons With Parkinson's Disease by Objective Measurement Using the PKG

The main objective of this study is to evaluate whether persons with Parkinson's disease (PwP) whose Parkinson's disease (PD) symptoms are uncontrolled have improved clinical patient outcomes and quality of life when managed with the aid of objective measurement and use of PKG target ranges compared to PwP treated using only standard of care (SOC) (medical history, physical examination).

This is a randomized controlled trial (RCT) to compare the value of the Personal KinetiGraph® (PKG®) System and SOC vs. the SOC alone for treatment of PwP. The study aims to evaluate clinical outcomes, quality of life outcomes, health economic benefits, duration of controlled status, and need for additional PD treatment through 3 years follow-up of PwP specifically treated to a target range when using the PKG data in the clinical management of PD in routine clinical care compared to those managed with SOC alone. All subjects will be treated by Movement Disorder Specialists and General Neurologists with expertise in PD. Both groups will be recommended to undergo treatment changes until they reach a "controlled state" that is determined by either the clinician using SOC (PKG- Group) or using recommended target ranges for PKG scores and SOC assessments (PKG+ Group). Investigators will utilize standard available treatments to manage these PwP in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to sign a written informed consent for study participation and comply with all required follow-up visits
* Presumed to have levodopa responsive PD
* Taking levodopa for at least 30 days prior to screening visit
* Planning to continue using levodopa for PD throughout study participation
* Able to increase levodopa by a minimum of 100mg/day
* Age inclusive at the time of consent of 55-80 years
* Has not received a PKG in the last 12 months

Exclusion Criteria:

* Evidence of atypical or secondary parkinsonism
* Presence of any non-parkinsonian tremors
* Contraindication to increasing levodopa
* Requires the addition of or dose adjustment of an anti-dyskinesia medication within the next 4 months
* Those who have received advanced therapies including individuals no longer actively utilizing these therapies, or planning to receive advanced therapies in the next 6 months
* MoCA score \<23 at screening visit
* Bedridden, wheelchair confined, or requires the regular use of an assistive gait device
* Predominant sleep period is during the daytime hours of 9am to 6pm (e.g. third shift worker)
* In the investigator's or sponsor's opinion, subject has any unstable or clinically significant condition that would impair the participant's ability to comply with study requirements or interfere with interpretation of the study endpoints
Validation of the CLAD Score Ifor Renal Colic Pain

Renal colic is a frequent reason for recourse representing 1 to 2% of emergency room admissions.

This study would validate the performance of the CLAD score in predicting the need for surgical management within 7 days of patients admitted to the emergency department for renal colic pain.

Renal colic is a frequent reason for recourse representing 1 to 2% of emergency room admissions. It results clinically in a lumbo-abdominal pain syndrome radiating into the genitals. The origin of this pain is the tensioning of the urinary tract, most frequently by a lithiasis creating a transient obstruction

Toulouse medical team has developed the "Complicated uroLithiasis and Alternative Diagnosis" (CLAD) score, which predicts the risk of requiring surgery within 7 days of admission of patients to the emergency room for renal colic

The aim of this study is to validate this CLAD-V score by collecting the elements of the CLAD score and the clinician's intuition is made available to practitioners in the emergency department.

All patients presenting to the emergency room for renal colic pain are eligible. The doctor in charge of the patient will have to examine him and take care of him according to the service protocol. The doctor must then complete the questionnaire provided.

A reminder of the patient on D7 is carried out to collect information on the need for surgery after the emergency or not.

Each center ensures inclusions and reminders on D7 and will only transmit the database

Eligibility Criteria:
Inclusion Criteria:

* Adult patients admitted to the emergency room for suspected renal colic
* Patient not objecting to participation

Exclusion Criteria:

* Patients unable to express their non-objection
* Pregnant women
CyclASol for the Treatment of Moderate to Severe Dry-eye Disease (DED)

The objective of this study was to compare the safety, efficacy, and tolerability of two different dose levels of CyclASol Ophthalmic Solutions to placebo (vehicle) and Restasis for the treatment of the signs and symptoms of Dry Eye Disease (DED).

This phase 2 study explored the safety, efficacy and tolerability of two CyclASol concentrations as one drop twice daily versus vehicle (placebo). In addition to the masked vehicle control arm, an open-label comparator arm consisting of Restasis was included.

The study explored a range of signs and symptoms of DED to gain an understanding of the possible treatment effects in comparison to vehicle and estimation of effect sizes. In line with current treatment guidelines, the proposed phase 2 population consisted of patients suffering from moderate to severe DED.

The primary treatment comparisons in this study were between the two CyclASol concentrations versus vehicle for the sign variable total corneal fluorescein staining and the symptom variable dryness severity visual analogue scale at day 113. All other comparisons between treatments groups were considered secondary analyses.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form and HIPAA (Health Insurance Portability and Accountability Act ) document
* Patient-reported history of dry eye in both eyes
* Current use of over-the-counter and/or prescription eye drops for dry eye symptoms
* Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion Criteria:

* Women who are pregnant, nursing or planning a pregnancy
* Unwillingness to submit a blood pregnancy test at screening and at the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control
* Clinically significant slit-lamp findings or abnormal lid anatomy at screening
* DED secondary to scarring or ocular or periocular malignancy
* History of herpetic keratitis
* Active ocular allergies or ocular allergies that are expected to be active during the study period
* Ongoing ocular or systemic infection at screening or baseline
* Wear of contact lenses within 3 months prior to screening or anticipated use of contact lenses during the study
* History of no response to previous topical Cyclosporine A and/or use of topical Cyclosporine A within 6 months prior to screening
* Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have any planned ocular and/or lid surgeries over the study period
* Presence of an uncontrolled systemic disease
* Presence of a known allergy and/or sensitivity to the study drug or its components
Free Fatty Acids: Short Exposure Study

This study will examine whether or not short, daily exposures change a person's ability to detect free fatty acids in a solution by its taste. Repeated exposure should improve a person's ability to detect free fatty acids.

The possibility that humans can taste non-esterified fatty acids (NEFA) - so-called fat taste - is a relatively new area of research. Previous work suggests that subjects require an average of between two and three testing sessions of approximately an hour each before they can reliably detect NEFA, and the average number of visits to get the lowest threshold is six. Streamlining this process is of great interest to researchers who wish to test many people as quickly as possible. Other taste qualities, including umami and sweet, have shown improvement in detection sensitivity in subjects that have undergone ten second exposures to these taste qualities for 10 days upon subsequent re-testing. We seek to determine if the same improvements can be seen with fat taste.

Eligibility Criteria:
Inclusion Criteria:

* good health
* available for multiple testing visits

Exclusion Criteria:

* have participated in a fat taste study in the past 6 months
Improving Surgical Patient Outcomes Through Implementation of a SemiStructured Intraoperative Anesthesia Handoff Tool

The purpose of this study is to assess the impact of a semi-structured intraoperative anesthesia handoff tool on patient outcomes and to assess the validity of the 5-Factor Perceived Shared Mental Model Scale (5-PSMMS) in a healthcare setting and whether the perception of Shared Mental Model (SMM) mediates the effect of the intraoperative handoff tool on postoperative outcomes


Eligibility Criteria:
Inclusion Criteria:

* Undergoing non-cardiac surgery in the main operating rooms (e.g. not the endoscopy suite or labor and delivery ward)
* Undergoing at least one permanent (e.g. end of shift) anesthesia clinician handoff

Exclusion Criteria:

* American Society of Anesthesiologists (ASA) Physical Status 6 (organ donors)
Strength Training After Hip Fracture Surgery

The purpose of this study is to examine the effect of progressive strength training of the fractured limb in patients with hip fracture, during admittance in an acute orthopedic ward. The primary study hypothesis is that the training will reduce the strength deficit in the fractured limb in comparison with the non-fractured limb. Secondary, that patients following the intervention will present larger improvements in physical function compared to controls.


Eligibility Criteria:
Inclusion Criteria:

* Primary hip fracture surgery
* 65 years or older
* Speak and understand the Danish language
* Able to give informed consent
* Home-dwelling with and independent prefracture indoor walking ability equal to New Mobility Score \>=2

Exclusion Criteria:

* Multiple fractures
* Weightbearing restrictions
* Patient unwilling to participate in appropriate rehabilitation
* Not able to cooperate to tests
* Terminal illness
* Patients who want an observer present at the information interview, but where such one is not available.
* Patients with a cervical hip fracture treated with Total Hip Arthroplasty or hip pins, due to expected short length of hospital stay.
Impact of Photobiomodulation Bone Healing Following Cystic Enucleation

A well-known issues confronted by oral and maxillofacial specialists are the osseous defects and dead spaces and how can be obliterated and augmented in the facial regions. Unerupted tooth and bone loss after its removal, remaining roots and enucleation of cysts; all of which makes prosthetic rehabilitation and implant application more complicated

Bone is undergoes remodeling via cycles of bone resorption and bone formation which is considered a mineralized connective tissue, an inflammatory immune reaction which is triggered by local injury which is thought to highly influence the outcome of the bone healing process.

Low-Level Laser Therapy (LLLT) is a form of phototherapy that involves the application of low power monochromatic and coherent light to areas of injuries and lesions. It has been shown to induce wound healing in non-healing bone defects .

Bone healing is a multidimensional process of reconstruction of the bone tissue with an overlapping timeline. Because of the regeneration ability of the bone, bone defects can heal spontaneously under suitable physiological environmental conditions. The healing process of the bone defect is time consuming, and new bone generation takes place slowly because of diminished of blood supply to the defect site and insufficiency of calcium and phosphorus to strengthen and harden new bone.

The low-level laser therapy (LLLT) has a positive effect on bone tissue metabolism . Moreover it is beneficial for the initial stages of alveolar bone healing and for further calcification; An experimental animal study in both diabetic and normal rats under histological observations and gene expression analyses have confirmed this when applied at a dose of 13.95 J/cm2 for 60 sec .

Eligibility Criteria:
Inclusion Criteria:

- patients (class I category according to American society of anesthesiologists) over 20 years and under 50 years of age, of either gender who are seeking cyst enucleation of painful intra-body maxillary cystic lesions 3 x 4 cm in size.

Exclusion Criteria:

* any systemic disease that interferes with bone healing,
* patients with significant medical condition,
* alcoholic individuals,
* patients on drugs that affect the central nervous systems,
* patients who reported the use of drugs that might interfere with pain sensitivity
* pregnancy,
* lactation
Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of REGN3918 in Healthy Volunteers

To evaluate the safety and tolerability of single ascending intravenous (IV) and subcutaneous (SC) doses and a multiple dose regimen.

Participants will be randomized to single IV or SC or multiple dose treatment with REGN3918 or matched placebo.

Eligibility Criteria:
Key Inclusion Criteria:

A subject must meet the follow criteria to be eligible for inclusion in the study:

1. Males and females from 18 to 50 years of age.
2. Subject is judged to be in good health based on medical history, physical examination, vital sign measurements and laboratory safety tests performed at screening and/or prior to administration of initial dose of study drug
3. The subject has a body mass index less than 30 kg/m2
4. Willingness to undergo vaccination and antibiotic prophylaxis against N. meningitides.

Key Exclusion Criteria:

A subject who meets any of the following criteria will be excluded from the study:

1. Any clinically significant physical examination abnormalities observed during the screening visit.
2. Hospitalization for any reason within 30 days of the screening visit
3. Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals.
4. Subject has a history of meningococcal infection.
5. Carriers of Neisseria meningitides based on cultures from naso-pharyngeal swabs during screening.
6. Subject has had a splenectomy.
7. Known allergy to penicillin class antibiotics
8. Known or suspected complement deficiency, or abnormal complement C3, C4 or CH50 during screening.
9. Recent (within the previous 2 months) bacterial, protozoal, viral or parasite infection requiring systemic treatment.
10. History of tuberculosis or systemic fungal diseases
11. HIV infection or HIV seropositivity at the screening visit
12. Positive HBsAg, HBcAb, or hepatitis C antibody at the screening visit
13. History of malignancy (except non-melanoma skin cancer or cervical in-situ)
14. Pregnant or breastfeeding women
15. Women of childbearing potential and men who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose

Note: Other protocol defined Inclusion/Exclusion criteria may apply
Oculocardiac Reflex Brain Wave Monitor

Oculocardiac reflex during routine strabismus surgery was prospectively observed in association with routine brain wave monitoring.

Providence Hospital institutional review board (IRB) approved this observational study without need for consent.

Introduction: The oculocardiac reflex (OCR), bradycardia that occurs during strabismus surgery, is blocked by anticholinergics and enhanced by opioids and dexmedetomidine. Two recent studies suggest that deeper inhalational anesthesia monitored by bispectral index (BIS) protects against OCR; the investigators wondered if our data correlated similarly.

Methods: In an ongoing, prospective study of OCR elicited by 10-second, 200 gram square-wave traction on extraocular muscles (EOM) from 2009 to 2013, anesthetic depth was estimated in cohorts using either BIS or Narcotrend monitors. The depth of anesthesia was deliberately varied between first and second EOM tested.

Eligibility Criteria:
Inclusion Criteria:

* all

Exclusion Criteria:

* those receiving anticholinergic medications