cyrilzakka/clinical-trials huggingface dataset:
Fusionless Treatment of Idiopathic Scoliosis With the SCOLI-TETHER System During The Growth Period

The goal of the study is to establish the safety and benefit of treatment of juvenile and adolescent idiopathic scoliosis (AIS) with the SCOLI-TETHER (MIScoli) System.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of juvenile or adolescent idiopathic scoliosis
2. Male and female subjects greater than 8 years of age with significant growth remaining
3. Risser Stage 0 or 1
4. Subjects should have at least three years of estimated growth remaining based on Risser staging
5. Major thoracic scoliosis with Cobb Angle \> 40° and \< 70° and Lenke I, II or V curve pattern. Cobb measurements refer to measures taken without a brace. Patients with curves greater than 30 degrees with attempted but failed brace treatment are also potential candidates for the procedure
6. Thoracic kyphosis (T5-T12) \< 50°
7. Instrumentation to be applied no more cephalad than T4 and no more caudal than L2 (inclusive)
8. Menses \< 4 months
9. Subject must be physically and mentally willing and able to comply with postoperative and routinely scheduled clinical and radiographic evaluations
10. Subject assent and parent/legal guardian consent obtained and documented.

Exclusion Criteria:

1. Scoliosis curve is less than 30° or more than 70°
2. Thoracic kyphosis is greater than or equal to 50° (T5-T12)
3. The vertebrae to be instrumented is less than 12mm in height (based on the staple size)
4. One of the vertebrae to be instrumented in less than 20.5mm in width (base on smallest screw length)
5. One of the vertebrae to be instrumented is more than 44mm in width (base on longest screw length)
6. Non-idiopathic scoliosis
7. Non-ambulatory
8. Subject with clinical diagnosis of osteoporosis, osteopenia, osteomalacia, Paget's disease and metabolic bone disease
9. Prior thoracic surgery
10. Abnormal neurological status at baseline
11. Any condition or therapy that the investigator believes might pose a risk to the participant or make participation in the study not in the participant's best interest
Forgotten Voices: Addressing Unmet Needs in Brain Tumor Caregivers

To conduct a mixed-method Phase Ia Define Trial of caregivers' participation in CALM therapy with post-session surveys and individual exit interviews in order to evaluate suitability and adapt the CALM intervention to the needs of caregivers in neuro-oncology.

Exploring caregivers' experiences of CALM intervention will inform more effective, targeted, supportive care for this traditionally underserved group in need of emotional support. We will use the data from this study to adapt the CALM intervention to the specific needs of caregivers in neuro-oncology

Eligibility Criteria:
Inclusion Criteria:

* Caregiver participants must be the caregiver of a brain cancer patient who is currently enrolled in DoD CA200896 (IRBHM20022755)
* Fluent in English
* Willing and able to attend a minimum of 3 CALM sessions via telehealth
* A caregiver is defined as the primary person who provides ongoing support to the brain cancer patient; it is not necessary that the caregiver lives with the patient or is related
* Patient participants must have enrolled in the linked HM20022755 study

Exclusion Criteria:

* Person does not consider themselves to be a caregiver of the patient
* Caregiver does not have a loved one (patient diagnosed with brain cancer) enrolled in DoDCA200896 (IRB HM20022755)
* Caregiver does not speak English
* Caregiver is unable to provide consent
* Caregiver does not have access to telehealth
* Caregiver is under the age of 18
* Professional caregivers who received financial compensation for their services are ineligible
Clinical and Radiographic Evaluation of Dental Implants Installed Between 2004 and 2010

The convenience sample to be included in the present study will consist of all individuals who had implants installed at the Dentistry Clinic of the University Santo Amaro, between the years 2004 and 2010. The following criteria will be evaluated: age; sex; presence of systemic disease; area in which the implant was installed; implant diameter and height; type of prosthesis installed; presence of bone resorption and annual maintenance.

The control of biofilm around implants is fundamental to the success of implant therapy, and it is the duty of the dentist to inform, guide and maintain patients in order to avoid pathological processes that may lead to the loss of the implanted component. The objective of the present study will be to evaluate by clinical and radiographic parameters the condition of oral implants placed for more than five years. The convenience sample to be included in this study will be composed of all individuals who had implants installed at the Dental Clinic of the University Santo Amaro, between 2004 and 2010. The following criteria will be evaluated: age; sex; presence of systemic disease; area in which the implant was installed; implant diameter and height; type of prosthesis installed; presence of bone resorption and annual maintenance. The success and survival rate of implants through the following parameters: pain; mobility; card index (IP); bleeding rate (IS); probing depth (PS); probing bleeding (SS) that will be measured on four faces by implant: mesial, buccal, distal and lingual / palatine. For the evaluation of bone loss, a conventional periapical radiograph will be performed at the moment of patient recall. Radiographs will be scanned and analyzed using Image Tool software to verify and determine the resulting linear distance between the implant shoulder and the bone crest. Factors such as smoking, annual maintenance appointments will be related to the presence of peri-implantitis.

Eligibility Criteria:
Inclusion Criteria:

* After evaluation, individuals may be allocated into groups according to the characteristics observed, for example: carriers of single implants, patients with overdentures, individuals with systemic diseases, smokers.

Exclusion Criteria:

* Individuals who need to use or suspend systemic medication to perform the proposed clinical exams will be excluded from the study.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 44847 Powder in Healthy Male Subjects

To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BI 44847


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males according to the following criteria:

   Based upon a complete medical history, including the physical examination, vital signs (BP, HR), 12-lead ECG, clinical laboratory tests
2. Age ≥ 18 and Age ≤ 50 years
3. BMI ≥ 18.5 and BMI ≤ 29.9 kg/m2 (Body Mass Index)
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria:

1. Any finding of the medical examination (including BP, pulse rate and ECG) deviating from normal and of clinical relevance
2. Any evidence of a clinically relevant concomitant disease
3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
5. History of relevant orthostatic hypotension, fainting spells or blackouts
6. Chronic or relevant acute infections
7. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
8. Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
9. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
10. Participation in another trial with an investigational drug within two months prior to administration or during the trial
11. Smoker (\> 10 cigarettes or \> 3 cigars or \> 3 pipes/day)
12. Inability to refrain from smoking on trial days
13. Alcohol abuse (more than 60 g/day)
14. Drug abuse
15. Blood donation (more than 100 mL) within four weeks prior to administration or during the trial
16. Excessive physical activities (within one week prior to administration or during the trial)
17. Any laboratory value outside the reference range that is of clinical relevance
18. Inability to comply with dietary regimen of study centre
19. Any ECG value outside of the reference range and of clinical relevance including, but not limited to QRS interval \> 120 ms. A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \> 450 ms or QT\> 500 ms).
20. A history of additional risk factors for Torsade des Pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)
21. The use of concomitant medications that prolong the QT/QTc interval
22. Elevated urinary glucose levels at screening (\> 15 mg/dl)
A Study to Evaluate the Safety and Efficacy of Paltusotine for the Treatment of Acromegaly (ACROBAT Evolve)

A Phase 2 double-blind, placebo-controlled, randomized withdrawal study is designed to evaluate the safety, efficacy, and pharmacokinetics of paltusotine (formerly CRN00808) in subjects with acromegaly that are responders to octreotide LAR or lanreotide depot.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects 18 to 75 years of age
2. Confirmed diagnosis of acromegaly that is controlled on stable doses of octreotide LAR or lanreotide depot
3. Females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control
4. Willing to provide signed informed consent

Exclusion Criteria:

1. Treatment naïve acromegaly subjects
2. Prior treatment with paltusotine
3. Pituitary surgery within 6 months prior to Screening or radiation therapy at any time prior to the study entry. Pituitary radiation therapy (within 3 to 4 years or more than 4 years prior to study entry) with recently documented elevated IGF-1 may be eligible.
4. History or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years.
5. Use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer
6. Positive test at Screening for HIV, hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV-Ab) or has a history of a positive result
7. History of alcohol or substance abuse in the past 12 months
8. Any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study
9. Cardiovascular conditions or medications associated with prolonged QT or those which predispose subjects to heart rhythm abnormalities.
10. Subjects with symptomatic cholelithiasis
11. Subjects with clinically significant abnormal findings during the Screening Period, and any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the subject's safety or ability to complete the study
12. Subjects who have been taking the following prior medications: pegvisomant (within the last 3 months), dopamine agonists (within the last 3 months) and pasireotide LAR (within the last 6 months)
13. Subjects taking octreotide LAR at a dose higher than 40 mg or lanreotide depot at a dose higher than 120 mg
14. Subjects who usually take octreotide LAR or lanreotide depot less frequently than every 4 weeks (e.g. every 6 weeks or 8 weeks)
Video Education: Capitalizing on Caregiver Time Spent in the Pediatric Emergency Department Waiting Room

The purpose of this study is to determine if video education is an effective means of caregiver education in the waiting room of a pediatric emergency department (ED). This will be tested with the showing of a child passenger safety video.


Eligibility Criteria:
Inclusion Criteria:

* caregivers of patients presenting to Children's Hospital of Wisconsin for treatment
* family use of automobile for transportation

Exclusion Criteria:

* non-English speaking caregivers
* triage level 1 or 2 or requiring immediate medical attention
Trial of Cannabidiol (CBD; GWP42003-P) for Infantile Spasms (GWPCARE7)

This trial consists of 3 parts: a pilot safety phase, a pivotal randomized controlled phase, and an open-label extension phase. The pilot phase only will be described in this record. 2 cohorts of 5 participants will be enrolled sequentially. All participants will receive GWP42003-P.


Eligibility Criteria:
Key Inclusion Criteria:

* Participant is aged 6- 24 months (inclusive) in the first cohort or aged 1-24 months (inclusive) in the second cohort, at the time of consent.
* Participant is diagnosed with IS and has failed to respond adequately following treatment with 1 or more approved IS therapies.
* To be considered hypsarrhythmia, as defined for use in the study, the electroencephalography (EEG) background must be slowed and have multifocal spikes. In addition, it must be either high voltage (above 300 µV) or have electrodecrement/discontinuity.

Key Exclusion Criteria:

* Participant is currently taking or has taken clobazam or any mammalian target of rapamycin (mTOR) inhibitor within the 2 weeks prior to the screening visit.
* Participant has a QT interval, corrected for heart rate with Bazett's formula (QTcB), of 460 msec or greater on ECG.
* Participant's caregiver is currently giving or has given recreational or medicinal cannabis, or synthetic cannabinoid-based medications, within the 1 month prior to the screening visit.
* Participant's caregiver is unwilling to abstain from giving the participant (including the participant's mother abstaining themselves, if breastfeeding)recreational or medicinal cannabis, or synthetic cannabinoid-based medications (other than the study drug) during the trial.
* Participant has any known or suspected hypersensitivity to cannabinoids or any of the excipients of the study drug, such as sesame oil.
* Participant has significantly impaired hepatic function at the screening visit.
* Participant has received an investigational medicinal product as part of a clinical trial within a minimum of 5 half-lives prior to the screening visit.
Daily Assessment of Mood and Social Media Behaviors Study

The purpose of this research study is to learn more about social media usage and its relation to emotions, biology, and mental health. Participants will complete daily assessments (5 times a day) over the course of 11 days in which they will report on their social media use, behaviors, and mood. During the first 4 days participants will be asked to continue using social media as typical. In the second half (7 days) participants will be randomized to social media usage groups (0 minutes, 30 minutes, 1 hour, 2 hour, 3 hours). There will be mental health and well-being measures provided at the beginning and end of the study. Lastly, to better understand how social media usage effects underlying mechanisms of stress, participants will be asked to provide saliva samples for 3 nights (pre, mid, and post) to assess for basal cortisol levels.


Eligibility Criteria:
Inclusion Criteria:

* Having a smartphone

Exclusion Criteria:

* Below age of 18
Reliability of Methods for Determining the Vibration Threshold

It is known that whole-body vibration (TVV) has beneficial neuromuscular effects such as muscle strength increase. These beneficial effects are explained by the muscular reflex response induced by TVV. Reflex latency measurement is frequently used in clinical and neurophysiological research. The latency of the reflex response induced by TVV is defined as the period between the onset of the vibration stimulus and the onset point of the spike in the EMG signal. The current research aimed to determine whether the cumulative average method is reliable for estimating the EST.

This is an experimental study for method development; a self-controlled (single group) study. Ten healthy male or female subjects between the ages of 18-45 will be included in the study. After obtaining informed consent from the subjects, 30 Hz low amplitude (2 mm) vibration for 30 seconds will be applied on the PowerPlate Pro5 device to meet TVV. After three minutes of rest, two sets of TVV will be applied for test purposes. For the test TVV, vibration will be applied at 25, 30, 35, 40, 45, 50 Hz frequencies, each lasting 30 seconds, with low amplitude.

Vibration stimuli detected by using an accelerometer fixed on the TVV platform will be recorded the Data acquisition (PowerLab data acquisition system (ADInstruments, Oxford, United Kingdom). Soleus EMG responses will be recorded using the superficial electrodes (Kendall Covidien). The sample rate for recordings will be 40KHz.

Latency calculation with Cumulative Average Method: It will be done. An 80-500 Hz band-pass filter and full-wave rectification will be applied to EMG recordings. The peak of reflex responses (spike) will be marked with the help of LabChart7 (ver 7.3.7, ADInstruments, Oxford, United Kingdom). According to this marked point, the averaging process covered 75 ms of the vibration data preceding the trigger and 15 ms after for each vibration frequency separately. Then, the average of the five vibration frequencies will be calculated for the accelerometer recordings and EMG recordings. The point where the standard error is lowest in the accelerometer recordings will be determined as the "effective stimulation point".

Eligibility Criteria:
Inclusion Criteria:

* Both gender
* 20-40 aged
* Healthy volunteer

Exclusion Criteria:

* People with any health problems
Northwest Adult Congenital Heart Disease Observatory

The incidence of congenital heart disease is about 8 per thousand live births. Thanks to advances in cardiac surgery, 90% of children born with heart defects reach adolescence and adulthood. Congenital heart defects are the leading cause of heart disease in young adults and expectant mothers in Western countries. The number of patients increases continuously as life expectancy increases. An increasing number of patients with complex heart defects survive to adulthood. The medico-surgical management of this highly specialized growing number of patients is difficult and requires a multidisciplinary collaboration. In France, an estimated 200,000 patients the number of carrier patients with congenital heart disease. Half of them will require monitoring, medical procedures, catheterizations and/or surgical re-intervention. No objective demographic data are currently available on the French patients. So, the investigators decided to set up an epidemiological project to better understand this cohort of patients. The main objective of this project is to obtain accurate epidemiological data needed to adapt the supply of care.


Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, aged 18 years
* Congenital heart disease operated or non-operated
* Followed by a cardiologist specializing in congenital heart disease in the inter northwest region of France

Exclusion Criteria:

* Patient refusal
Physiological Brain Atlas Development

Enrollment of candidates undergoing a deep brain stimulator (DBS) implant.

The study proposes the enrollment of candidates undergoing a deep brain stimulator (DBS) implant. Data will be collected before, during and after surgery and will be electronically entered into the Atlas database where it will be stored indefinitely.

The purpose of the study is to create an Atlas to store physiological information utilizing non-rigid MRI normalization algorithms. In addition to collating and analyzing the physiological atlas in a statistical manner that allows the surgeon to predict optimal targeting locations for DBS implants based on multiple physiological variables, including pre-operative severity of disease, intraoperative neurophysiological observations, and post-operative response to DBS stimulation therapy.

Eligibility Criteria:
Inclusion Criteria:

* Any patient between the age of 7-90
* Patients who have undergone deep brain stimulation (DBS) surgery as standard of care at The Ohio State University

Exclusion Criteria:

* None
Long-term Outcome After Gestational Diabetes and Diabetes in Pregnancy

The primary objectives of the proposed project are to assess the long-term effects of prenatal exposure to gestational diabetes or diabetes on the maturation and health of the offspring. In addition, the long-term changes on the health of the affected mothers will be investigated, taking into account the metabolic adjustment during index pregnancy. The expected results will help to establish possible prevention strategies to fight the epidemic of non-communicable diseases for the offspring and the mothers.

Investigation of the long-term outcome of mother-child pairs after diabetic pregnancies and a comparison group regarding metabolic, cardiovascular, neurocognitive and reproductive long-term changes as a function of the course of pregnancy and metabolic control

Eligibility Criteria:
Inclusion Criteria:

* For the pilot project: Initial participation in the preliminary study
* Written Informed Consent
* Singleton pregnancies
* Delivery at the University Hospital Jena

Exclusion criteria:

* Severe physical and mental illness
* Patients who refuse to participate in the study or drop out
* Premature birth, i.e. birth of the child \<37/0 weeks of gestation
* Serious pregnancy complications
* Prenatally known serious malformations
An Observational Study Evaluating Patient Satisfaction and Quality of Life Associated With Switching Insulin

The purpose of this study is to estimate the direct costs associated with switching, in either direction, between a rapid-acting analog therapy and short-acting human insulin therapy within the first year following the switch. The additional goals are: 1)to assess the impact of a switch from or to a rapid-acting analog insulin therapy on patient treatment satisfaction, 2) to assess the impact of a switch from or to a rapid-acting analog insulin therapy on patient quality of life, 3) to assess the impact of switch from or to the rapid-acting analog insulin therapy on the quality of metabolic control and, 4) to estimate the total costs (direct and indirect) associated with switching, in either direction between rapid-acting analog and short-acting human insulin within the first year following the switch.


Eligibility Criteria:
Inclusion Criteria:

* are at least 18 years of age
* according to the clinical judgement of the investigator have been diagnosed with type II diabetes
* have presented within the normal course of care
* at the baseline visit are being treated with any therapy including a rapid-acting analog insulin component or any therapy including a short-acting human insulin component and are switching from one form of therapy to the other
* are not simultaneously participating in a study that includes an investigational drug or procedure at entry into the study
* have been fully informed and have given their written consent for the use of their data
* have a sufficient understanding of the primary language of the country such that they will be able to complete the questionnaires

Exclusion Criteria:

* no specific exclusion criteria exist for this study