cyrilzakka/clinical-trials huggingface dataset:
Long-term Outcomes and Life Satisfaction of Adults With Pediatric-Onset Spinal Cord Injuries

The purpose of this study is to assess life satisfaction and long-term outcomes (i.e., medical and psychosocial) of adults who sustained spinal cord injuries (SCI) as children or adolescents.

The ultimate goal of rehabilitation for children and adolescents with spinal cord injuries (SCIs) is to assure that they can grow up to have as productive and satisfying lives as their peers. Understanding factors associated with these outcomes of our patients after they have become adults may help to identify interventions and rehabilitation strategies that will optimize long-term outcomes. Long-term studies of adults with pediatric-onset SCI are needed to identify important outcomes, including survival, participation, health status and health-related quality of life, and life-satisfaction. Further, these outcomes need to be compared to population norms. Predictive models of important outcomes will be developed using independent factors, including demographic, impairment, functional limitation, participation, and environmental and personal factors. In addition, the impact of age at injury, upper extremity reconstruction or functional electrical stimulation implants, and the Mitrofanoff procedure on adult outcomes will be assessed. The stability of selected outcomes in comparison to normative and census data will be determined and factors associated with changes in these outcomes will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Individuals who are 19 years of age and older
* Were injured at the age of 18 years or younger
* Received care at Shriners Hospitals for Children in Chicago, Philadelphia, or Northern California

Exclusion Criteria:

* Non-English speaking individuals due to lack of measures in languages other than English and lack of foreign-speaking research assistants
* severe brain injury
SJOV vs. HFNO for Hypoxia During Procedural Sedation at High Altitudes

This study aims to compare the effect of the use of supraglottic jet oxygenation and ventilation (SJOV) with high-flow nasal oxygen therapy (HFNO) on reducing the rate of hypoxia during gastrointestinal endoscopic procedures in deeply sedated patients at high altitudes.

The participants will be randomly allocated to either SJOV or HFNO in a 1:1 ratio using block randomization with variable block sizes of four or six randomized. In the HFNO group, oxygen supplementation is delivered at 35 liters min-1 with a fraction of inspired oxygen (FiO2) of 100%. In the SJOV group, SJOV is conducted using a Wei nasal jet tube (WNJ, Well Lead Medical Co. Ltd, Guangzhou, China) which is connected to a manual jet ventilator (Well Lead Medical Co. Ltd, Guangzhou, China) via its jet port. The initial settings of SJOV were as follows: driving pressure (DP) 15 psi; respiratory rate (RR) 20 bpm; inspiratory-to-expiratory (I/E) ratio 1:2, and gas supply, 100% oxygen.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years or older;
2. underwent routine gastrointestinal endoscopy under procedural sedation;
3. consented to participate in this trial.

Exclusion Criteria:

1. infection of the upper airway;
2. anatomical abnormalities of the face, nose, and upper airway;
3. coagulopathies;
4. anticipated or known difficult airway;
5. known allergy against propofol, soybeans, and egg;
6. absence from the high-altitude environment during the past 3 months.
Flow-Restorative Yoga to Decrease Pain and Inflammation

The Restorative Flow Yoga Study is a pilot project looking at whether restorative flow yoga will reduce inflammation and pain in women 60 and older who experience chronic pain.

The aims of the study are to (1) evaluate the feasibility of implementing a restorative-flow yoga randomized trial (24 classes, held twice per week) for women aged 60 or older who experience chronic pain; and (2) evaluate the preliminary efficacy of restorative-flow yoga to decrease pain and inflammation among women aged 60 or older. Feasibility measures will include three areas of focus (a) acceptability, (b) implementation, and (c) demand and use, evaluated using recruitment rate, retention rate, class and home practice adherence rates, resource utilization, and safety. With a sample size of 40, this pilot feasibility study is likely under-powered to determine intervention effects. However, the study will evaluate preliminary efficacy of the yoga intervention. The study will measure BMI, blood pressure, resting heart rate, physical function measures, and inflammatory markers C-reactive protein, IL-2, IL-1β, TNF-α, IL-6, IL-4, and IL-10) at baseline and outcome assessments (after 24 class sequence).

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 60 or older
* Report AVERAGE severity of 3 or higher on the brief pain inventory
* Blood pressure is less than 160/100 mm Hg
* Heart rate is between 55-110 bpm
* Able and willing to obtain physician's approval to participate

Exclusion Criteria:

* Currently practicing yoga two or more times per week
* Cognitively impaired
Impact of SPEAC® System Data on Therapeutic Decisions Related to Convulsive Seizure Patient's Refractory to AEDs

This is an open label, randomized, prospective study of the impact on healthcare utilization of a surface Electromyography (sEMG) based seizure monitoring and alerting system for Veterans with seizures with upper extremity motor involvement, that are refractory to three or more antiepileptic drugs.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is a veteran with a reported history of motor seizures (epileptic, non-epileptic or unknown) with upper extremity motor involvement, presenting with questionable spell characterization.
2. Subjects suspected of experiencing one or more spells per month.
3. Subjects has failed at least 3 anti-epileptic drugs (single or combination).
4. Male or Female between the ages 22 to 99.
5. If female and of childbearing potential, subject must agree to not become pregnant during the trial.
6. Can understand and sign written informed consent or will have a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments.
7. Subject or Primary Caregiver must be competent to follow all study procedures.
8. Subject must be willing to use the Seizure Monitoring and Alerting System for a prolonged period (up to five months), for a minimum of 30 hours/ week.

Exclusion Criteria:

1. The subject cannot be pregnant, or nursing.
2. The subject cannot be sensitive or allergic to adhesives or tapes.
3. The subject may not be enrolled in another Clinical Trial.
4. The subject is homeless or in a home without a power supply.
Study of the Psychometric Properties and a Measure of Utility Determinants ( the SF- 6D) in Patients With Early Inflammatory Low Back Pain

The general main objective of our study is to investigate the psychometric properties, the levels and determinants of the extent of SF- 6D utility in patients followed for recent back pain inflammatory disease.

The specific objectives are :

* Study the feasibility of the tool considering missing data, distribution, construct validity, reproducibility, sensitivity to change or clinically different groups (discriminative ability) the extent of SF -6D utility .
* Study the impact of socio-demographic characteristics, disease characteristics and quality of life, comorbidities at baseline on the measurement of utility and sensitivity to change.


Eligibility Criteria:
Inclusion Criteria:

* The patient should be given free and informed consent and signed the consent

  * The patient must be affiliated or beneficiary of a health insurance plan
  * patients aged 18 years and under 50
  * inflammatory back pain (buttocks , lumbar or thoracic spine )
  * fulfilling the criteria of Calin or Berlin (30,31)
  * duration of symptoms than three months and less than three years
  * symptoms suggestive of spondyloarthritis as assessed by the local investigator ( score≥5 on a numerical scale from 0 to 10 where 0 = no evocative and 10 = very suggestive of spondyloarthritis ) .

Exclusion Criteria:

* Another clearly defined spinal disease (eg discarthrose )

  * history of treatment with biotherapy
  * taking glucocorticoids allowed only in low dose of less than 10mg of prednisone daily and stable for at least four weeks before inclusion
  * Current or history anomalies that could interfere with the validity of informed consent and / or prevent a patient's optimal adhesion to the cohort (eg , alcoholism , mental illness) .
Treatment of Severe Peanut Allergy With Xolair (Omalizumab) and Oral Immunotherapy

Severe peanut allergy is different from other allergic reactions because it can lead to fatal reactions and is an invisible disability. There is no cure today. The purpose of this study is to treat children and adolescents with severe peanut allergy with oral immunotherapy with peanuts under the protection of anti-IgE (immunoglobulin E) antibodies (omalizumab), and thereby inducing tolerance to peanuts. The treatment will be monitored by basophil cell stimulation (CD-sens).

Oral immunotherapy (OIT), where the food protein is consumed in increasing amounts, have been studied with good results, but allergic reactions has been a major problem. Anti-IgE antibodies (omalizumab) block allergy antibodies so that the allergic reaction is absent. A new test in which basophil cells stimulated with allergen in vitro, CD-sens, showing cell sensitivity, correlates well to peanut challenges.

Twenty children/adolescents, 12 to 22 years, with severe peanut allergy will be treated with omalizumab and the effect evaluated with CD-sens. If the CD-sens is negative a peanut challenge will be performed. If the challenge is negative the OIT will start: 1, 2, 4, 8 g peanuts/day in two-week intervals followed by a maintenance dose of 10 g peanuts/day while continuing treatment with omalizumab. If the CD-sens is still negative the withdrawal of omalizumab will start by halving the dose in several steps.

The study is independent of pharmaceutical companies. Omalizumab is dosed according to body mass and the amount of total IgE antibodies and therefore every individual has an individual study duration. In average the duration of the study is estimated to 52 weeks +/-40/20 weeks. Inclusion in the study is expected to last for the 2 coming years.

A treatment without serious side effects for those with severe food allergies would give a great benefit with reduced anxiety and fear, but also major health economic benefits in the form of fewer hospitalizations, sick leave, and to a greater extent completed school and education.

Eligibility Criteria:
Inclusion Criteria:

* IgE to peanut, Ara h 1, Ara h 2 and Ara h 3
* IgE to an airborne allergen i.e. cat, dog, horse, birch, grass etc.
* Clinical allergic reactions to peanut the last 5 years
* Positive conjunctival challenge to the selected airborne allergen
* Positive CD-sens to peanut and the selected airborne allergen
* IgE according to the recommendations of the manufacturer
* Written consent

Exclusion Criteria:

* No severe diseases like renal failure, hart disease, immunodeficiency, diabetes or other severe chronic diseases
* Pregnancy
* No previous hypersensitivity reactions to sucrose, histidine, polysorbat 20 or omalizumab
A Comparison Between Two Post-operative Dressings

Surgical site infections are one of the leading causes of post-operative morbidity and mortality worldwide. The ideal post-operative dressing is impermeable and remains intact preventing contamination of the incision with microorganisms. In addition, it is often difficult for the patient to identify breaks in dressing integrity. This trial compares a post-operative dressing (DrySee® Inc. Houston Tx) with moisture detection allowing the patient to recognize when the dressing is compromised to a standard post-operative dressing (Tegaderm® + Pad, 3M, St. Paul, MN). The ideal dressing also allows the patient to shower without removing the dressing.

Healthy subjects drawn from the general population. will undergo a 1.5cm incision on the volar forearm of each arm. The incision will be closed with streriostrips. The subject's incisions will then be randomized to receive either a Tegaderm® + Pad transparent film dressing or DrySee® dressing with moisture detection. The incisions will be photographed three times per week. Data on dressing wear time, integrity and adverse events will be collected every two days in the clinic.

Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years old.
2. Subject has read, understood, and signed approved consent, and is willing to participate and comply with the study procedures and requirements.

Exclusion Criteria:

1. Subject on an investigational drug or therapeutic device within 30 days of the study visit.
2. Presence of a condition that PI considers will compromise the subject's ability to participate in the study.
3. Known allergy to any of the dressings or their components.
4. The subject has a history of excessive bleeding.
5. The subject has a history of keloid formation.
TRE in Type 2 Diabetes (See Food Study 3)

Hyperglycemia in patients with Type 2 Diabetes Mellitus is initially treated with metformin coupled with intentional caloric restriction, which is difficult to sustain due to multiple barriers, including acquiring the necessary knowledge, teaching the intervention, cost of delivery and potential burden on quality of life. In contrast to intentionally restricting calories, time restricted eating (TRE), presents a simplified view of eating focused on restricting the eating window, which allows ad libitum intake per a person's dietary preferences during a daily fixed eating window. This study proposes a 24 week feasibility study to test if TRE is a viable alternative to Caloric Restriction in improving glycemic measures while accounting for weight loss in overweight/obese patients \[BMI:25-45 kg/m2\] with metformin-only treated Type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Overweight/obese adults with metformin-only treated type 2 diabetes
* 18-65 years old
* BMI:25-45 kg/m2
* HbA1c: 6.5-8.5%
* Self-reported weight must be stable \[±5 pounds\] for at least 3 months prior to the study
* Owns a smartphone.

Exclusion Criteria:

* Active or anticipated pregnancy during the study
* type 2 diabetes treated with medications other than metformin
* presence of eating disorders as noted by screening survey.
Visual Performance of New Apodized Diffractive Multifocal IOL With Addition of Plus Three

The purpose of the study is to determine whether implantation of a multifocal IOL with a modified addition at lens plane(Restor +3) results in better intermediate visual acuity with similar performance at distance and near compared to other multifocal IOL with similar design but with higher addition at lens plane. Patient's contrast sensitivity of vision and best reading distance following Restor +3 implantation were also assessed.

Study hypothesis: the implantation of an intraocular lens (IOL) with a modified addition at lens plane (restor +3, Alcon Laboratories,Inc) results in better intermediate visual acuity with similar distance and near visual acuity after cataract surgery.

Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D (diopters) will be eligible for inclusion in the study. Exclusion criteria will be any ocular diseases, such as corneal opacities or irregularity, dry eye, amblyopia, anisometropia, glaucoma, retinal abnormalities, surgical complications, IOL tilt, IOL decentration greater than 0.4 mm (estimated by retroillumination), or incomplete follow-up.

Patients will be examined before surgery and at 1, 7, 30, 90 days and 3and 6 months after surgery.

Eligibility Criteria:
Inclusion Criteria:

* •Patients with bilateral visually significant cataract with corneal astigmatism lower than 1.0D (diopters)

Exclusion Criteria:

* Ocular diseases, such as corneal opacities or irregularity, dry eye amblyopia, anisometropia, glaucoma, retinal abnormalities
* Surgical complications
* Intraocular lens (IOL) tilt, IOL decentration greater than 0.4 mm (estimated by retroillumination)
* Incomplete follow-up.
Effect of ERIG Injection on Day 7 After First Dose of Rabies Vaccination to Rabies Immune Response

No study was conducted to evaluate the rabies neutralizing antibody titers after RIG injection on day 7. The only study that has supported the delay of RIG administration was done in 1996 by our institute, of which RIG was given on day 5 with the original Thai Red Cross intradermal regimen (2-2-2-0-1-1).

Rabies immunoglobulin (RIG) should be administered as soon as possible after the initiation of post-exposure prophylaxis. RIG should not be given after day 7 following the first rabies vaccine dose, because circulating neutralizing antibody will have begun to appear. Nevertheless, no study was conducted to evaluate the rabies neutralizing antibody titers after RIG injection on day 7.

The only study that has supported the delay of RIG administration was done in 1996 by our institute, of which RIG was given on day 5 with the original Thai Red Cross intradermal regimen (2-2-2-0-1-1). The ongoing study would prove the validity of the recommendation and eliminate the controversies in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 60 years
* WHO category III rabies exposure
* Received rabies vaccination on day 0 and 3.

Exclusion Criteria:

* Received RIG
* Immunocompromised hosts or receiving immunosuppressive therapy
* Received blood or blood product within 3 months
* Received anti-malarial drugs
Deep Brain Stimulation for the Treatment of Alzheimer's Disease

The purpose of this clinical study is to investigate the safety and efficacy of deep brain stimulation (DBS)as a treatment option for patients with cognitive, behavioral, and functional disability of Alzheimer's disease.

Open label pilot study

* Expected direct benefit on the modulation of neuronal networks.
* Expected indirect benefit via potential enhancements of memory, executive functions, cognition behavioral control, and functional abilities.

Up to 10 subjects will be implanted with bilateral DBS systems, participants are expected to be on study for about 23 months.

* Develop a multidisciplinary clinical research protocol to evaluate the efficacy of ventral striatum, nucleus accumbens, and internal capsule for the amelioration of disability caused by Alzheimer's Disease.
* Enroll up to 10 patients into an open label study to evaluate the safety and efficacy of DBS for Alzheimer's Disease patients with mild to moderate disability.
* Determine an initial DBS titration and stimulation settings protocol for use in subsequent controlled trials.
* Evaluate the outcomes of this study based on clinical, laboratory, biomarker, imaging, cognitive, behavioral, and functional assessments.
* Determine what domains of cognitive, behavioral and functioning impairment show the greatest response to DBS.
* Examine the potential benefit of stimulation combined with behavioral and rehabilitation interventions in comparison to stimulation alone.
* Evaluate the influence of DBS on physiological and functional changes in cortical and subcortical networks.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable AD according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria

Exclusion Criteria:

* Has significant neurological disease, other than Alzheimer's disease, e.g., multiple sclerosis, Parkinson's disease and ischemic stroke, or severe brain atrophy or the presence of subdural hygromas or subdural hematomas.
* Evidence of substance abuse (alcohol or other drug) abuse or dependence during the previous 12 months (DSM-IV Criteria).
Urdu Version Of Cumberland Ankle Instability Tool: Reliability And Validity Study

The purpose of this study is to check reliability and validity, of translated Urdu version of the Cumberland Ankle Instability Tool develop and test its psychometric properties and responsiveness in Urdu speaking population in Pakistan endure with Ankle sprain and ankle instability complaints.

The Urdu version of the Cumberland Ankle Instability Tool will be translated and dignified for internal reliability test-retest consistency and cross cultural guidelines of self-reported measures, to evaluate validity (convergent and discrimination)of the sample of 125 participants who experience ankle sprain, participants choose by convenience sampling technique reinforced on already elaborated inclusion/exclusion criteria.Evaluation Form will be filled by a patient twice an day by observer for inter observer assessment , with an interval of 30 minutes to 2 hours between the first and second application. Third assessment will be carried out after 7 days obtained by 1st Observer (re-testing),they completed Cumberland Ankle Instability Tool Urdu version who had ankle sprain in past 3 months and also its correlation checked with lower extremity functional scale, visual analogue scale, and Short Form - 36 short form health survey participant also completed these scales, In general population with ankle sprain and ankle instability in this study we intended to translate the original version of Cumberland Ankle Instability Tool into Urdu cross- culturally adaptation and examine psychometric properties and cut-off score of the Cumberland Ankle Instability Tool Urdu version.

Eligibility Criteria:
Inclusion Criteria:

* Participants who are 18 years of age and
* Participants who were able to understand and complete the self-reported questionnaires (native Urdu speakers, with at least 8 years of education).

Exclusion Criteria:

* People who have ankle sprain episode and/or lower extremity injury within the last 2 months and/or any neurological or neuromuscular disease.
* Participants were also excluded if they did not fill out 2 or more questions of the Urdu Version Of Cumberland Ankle Instability Tool
Zevalin Post-marketing Surveillance in Japan

This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Zevalin for relapsed or refractory, CD20+, low grade B-cell non-Hodgkin's lymphoma and Mantle cell lymphoma. The objective of this study is to assess safety and efficacy of using Zevalin in clinical practice. This study is also all case investigation of which the enrollment period is five years, and all patients who received Zevalin will be recruited and followed 13 weeks after the administration.


Eligibility Criteria:
Inclusion Criteria:

Patients who received Zevalin for relapsed or refractory:

* CD20+
* low grade B-cell non-Hodgkin's lymphoma
* Mantle cell lymphoma

Exclusion Criteria:

* Patients who are contraindicated based on the product label
Improved Management and in-Hospital Mortality

The study intend to evaluate whether the use of standardised malaria case management protocol plus financial incentives added to the availability of free drugs reduce the case-fatality at the paediatric ward.

Mortality at the national paediatric ward in Guinea-Bissau is very high. During a civil war in 1998/1999 the hospital case fatality (CF) decreased by more than 40%, increasing again after the the war. This was attributed to the available free drugs from the humanitarian aid and food incentives to the personnel. Free emergency kits for treatment of severe malaria was introduced, however the CF did not decline. Therefore, the ward was split into two groups of rooms: intervention and control. All the staff of the ward was trained in the use of a standardised guideline for treatment of severe malaria and randomly assigned to one of the groups. All children hospitalised for malaria received the drug emergency kits. The only difference in the intervention group were the small financial incentives and supervision for strict adherence to the guidelines procedures.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalization due to malaria
* Non per os

Exclusion Criteria:

* Consent from parent/caretaker declined