cyrilzakka/clinical-trials huggingface dataset:
A Study of Freeze-dried Human Protein C Concentrate (TAK-662) in Participants with Congenital Protein C Deficiency

This study is conducted in Japan of Freeze-dried Human Protein C Concentrate (TAK-662) used to treat participants with congenital protein C deficiency.

The main aim of the study is to evaluate for adverse events and effectiveness of congenital protein C deficiency (TAK-662).

During the study, participants with congenital protein C deficiency will be administered with TAK-662 intravenous injection in under routine normal practice. The investigators will evaluate adverse events due to TAK-662 for 12 months. For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation, the investigator will evaluate for 24 months as a maximum. The study sponsor will not be involved in how the participants are administered but will be recorded what happens during the study.


Eligibility Criteria:
Inclusion Criteria:

- All participants with congenital protein C deficiency who are administered with Freeze-dried Human Protein C Concentrate (TAK-662).

Exclusion Criteria:

- None
Expression Levels of RISC and Microprocessor Complex Components in Epithelial Skin Cancer

MicroRNAs (miRNAs) are very small endogenous RNA molecules about 22-25 nucleotides in length, capable of post-transcriptional gene regulation. miRNAs bind to their target messenger RNAs (mRNAs), leading to cleavage or suppression of target mRNA translation based on the degree of complementarity. miRNAs have recently been shown to play pivotal roles in diverse developmental and cellular processes and linked to a variety of skin diseases and cancers. In the present study, the investigators examines the expression profiles of the microprocessor complex subunit DGCR8 and the RISC components TARBP1, TARBP2, argonaute-1, argonaute-2 and PACT in epithelial skin cancer and its premalignant stage.

Patients with premalignant actinic keratoses, basal cell carcinomas and squamous cell carcinomas were included in the study. Punch biopsies were harvested from the center of the tumors, from sites of healthy skin and a healthy control group. DGCR8, TARBP1, TARBP2, argonaute-1, argonaute-2 and PACT mRNA expression levels were detected by quantitative real-time reverse transcriptase polymerase chain reaction.

Eligibility Criteria:
Inclusion Criteria:

* epithelial skin cancer

Exclusion Criteria:

* other known previous malignancies
Validity, Reliability and Reproducibility of Plain Radiographic Measurements After Total Hip Arthroplasty

In total hip arthroplasty (THA), radiographic preoperative planning and postoperative evaluation of acetabular component, femoral offset (FO) and leg length discrepancy (LLD) require good validity, interobserver reliability and intraobserver reproducibility.

Questions/purposes: (1) Evaluate the validity of the Sundsvall method of FO measurement by comparing it to a standard FO measurement method. (2) Evaluate the interobserver reliability and intraobserver reproducibility of measurement of FO, LLD, acetabular cup inclination and anteversion.

90 patients with primary unilateral osteoarthritis (OA) were included in this prospective study. On postoperative radiographs FO by the Sundsvall method, FO by a standard method, LLD, acetabular cup inclination and anteversion were measured. The interobserver reliability and intraobserver reproducibility were made by three independent observers. The validity and degree of prediction of Sundsvall method are measured by comparing its results with the standard method.


Eligibility Criteria:
Inclusion Criteria:

* unilateral total hip replacement with either a cemented Lubinus SP II system (Link, Germany) or an uncemented CLS stem and Triology cup (Zimmer, U.S.A).

Exclusion Criteria:

* Patient with secondary (OA), previous spinal, pelvic, or lower limb injuries or fractures were excluded.
APOE in the Predisposition to, Protection From, and Prevention of Alzheimer's Disease

The purpose of this study is to track changes in the brain related to Alzheimer's disease. The results from this study will be used to develop new approaches to prevent or delay the onset of memory and thinking problems associated with Alzheimer's.

This study aims to establish, use, and extensively share a comprehensive longitudinal resource of genetic, non-genetic, and cognitive data, brain imaging and fluid biomarker measurements of amyloid-β, tau pathophysiology, neurodegeneration, and inflammation and biological samples to advance the study of cognitively unimpaired older adults at six levels of genetic risk for Alzheimer's disease due to their APOE genotype including understudied APOE2 and APOE4 homozygotes (HMs) at the lowest and highest risk and those APOE4 HMs and heterozygotes (HTs) who remain unimpaired at older ages due to unknown protective factors and spared pathophysiological effects despite their genetic risk.

Each participant will provide blood samples for clinical lab analysis, DNA, RNA, plasma, serum, and peripheral blood mononuclear cells (PBMCs) every 12 months; amyloid and tau PET scans, a nearly one hour battery of MRIs, a lumbar puncture (LP) for the collection of CSF samples, and a comprehensive battery of cognitive, behavioral, risk factor, and other assessments every 24 months. Extracted DNA will be used to characterize the participant's APOE genotype, screen for rare APOE variants that might make them eligible for other studies, and perform whole genome sequencing (WGS) and genome-wide genotyping.

Eligibility Criteria:
Inclusion Criteria:

* Male or female age 50 to 90 years old in good general health with no diseases expected to interfere with the study.
* Willing to undergo health and cognitive assessments, brain imaging sessions (MRI and PET), and collection and banking of blood with venipuncture and CSF by lumbar puncture for genetic research, biomarker research, and DNA banking.
* Determined to be cognitively unimpaired by PI (mechanisms may include verbal interview, participant or study partner reports or specific scores on cognitive assessments)

Exclusion Criteria:

* Participants with significant health issues or medical diseases that may interfere with participation, including infectious diseases that pose a risk to study personnel.
* For PET or MRI: Female participant who is pregnant, lactating, or of childbearing potential without a negative pregnancy test or being two years postmenopausal or surgically sterile.
* For MRI: Any contraindication for MRI including, but not limited to, pacemaker, aneurysm clips, artificial heart valves, ear implants, metal fragments or foreign objects in the eyes, skin, or body.
* For CSF collection: Medical or surgical contraindication for lumbar puncture (e.g. on anti-coagulant therapy or had prior lumbar spinal surgery).
Liver Cirrhosis Patients' Digital Health Literacy and Perspective on Digital Healthcare, a Multicenter Questionnaire Study

The goal of this study is to investigate digital health literacy in liver cirrhosis patients.

Participants will fill in two questionnaires by email or mail.


Eligibility Criteria:
Inclusion Criteria:

* Liver cirrhosis diagnosis, based on liver biopsy, fibroscan (elastography), radiographic imaging and/or clinical criteria according to applied guidelines at the time of inclusion
* Age 18 years or older
* Treated at Gastroenterology department

Exclusion Criteria:

* Objection to be approached for scientific studies requests, documented in electronic patient record
Arthroscopic Assisted Volar, Dorsal or Combined Capsulodesis in Scapholunate Ligament Injury.

The aim of this case series study is to test the efficacy of arthroscopic assisted volar, dorsal or combined scapholunate capsulodesis in the management of scapholunate ligament injuries.

The aim of this case series study is to test the efficacy of arthroscopic assisted volar, dorsal or combined scapholunate capsulodesis in the management of scapholunate ligament injuries. All patients will be assessed preoperatively by careful history taking , full general and local examination and radiological evaluation using wrist plain X-rays (Standard PA, clenched-fist PA , PA in ulnar deviation , lateral projection in neutral ,flexion and extension ) and wrist Magnetic resonance imaging.an informed written consent was taken before any surgery. The procedure starts with a standard radiocarpal and then midcarpal arthroscopy. During the arthroscopic examination ,several factors are assessed, including the location of the SLIL injury (volar, membranous, dorsal, or complete), the condition of the cartilage, the reducibility of the carpus, and other associated pathologies like TFCC injury. Classification is done using Geissler Classification, Garcia Elias Classification and EWAS classification.Volar capsulodesis using Hayman Lui et al or Del Pinal et al method and/or dorsal capsulodesis using original Mathoulin technique or combined capsulodesis were done.

Eligibility Criteria:
Inclusion Criteria:

* Sex: both sexes.
* Age: above 18 years
* Lesion: subacute or chronic scapholunate ligament injury
* partial and complete SLIL tears

Exclusion Criteria:

* Acute scapholunate ligament injury
* irreducible carpal malalignment
* posttraumatic arthritis
* associated fractures that could affect the functional outcome
Rehabilitation Outcomes Study

This pilot health services interventional study aims to prospectively assess the effectiveness of a pre-treatment rehabilitation (prehabilitation) program across a diverse cohort of adult cancer patients via a randomized pilot trial. Upon screening and identification of high-risk features through a central navigation process, patients referred to oncology clinics will be approached to participate in tailored prehabilitation interventions. The study will track and analyze functional outcomes and quality of life aiming to demonstrate the comprehensive benefits of prehabilitation on the cancer treatment continuum. We hypothesize that this referral program is feasible and that those randomized to the intervention arm will have superior functional outcomes and global health-related quality of life.

The rationale for this study is anchored in the urgent need to optimize the cancer care trajectory for high-risk patients whose treatment outcomes and quality of life are jeopardized by the multifaceted challenges of their disease. While prehabilitation has shown potential to mitigate these adverse effects, the optimal methods for identifying and connecting these high-risk individuals to appropriate prehabilitation resources remain underexplored. This study, with its systematic approach to enrolling a diverse adult cancer population, endeavors to investigate not only the benefits of prehabilitation interventions but also the effectiveness of a targeted referral process. By doing so, it aims to uncover novel strategies for efficiently allocating prehabilitation resources, thereby enhancing the precision and impact of supportive cancer care.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information.
* Subjects are willing and able to comply with study procedures based on the judgement of the investigator.
* Age ≥ 18 years at the time of consent.
* The subject has been screened by the Central Oncology Navigation Program and referred to cancer care at the University of North Carolina Medical Center.
* Answer "yes" to at least one of the following screening questions:

  1. Does your health interfere with any of your activities of daily living (ADLs)?
  2. Have you fallen, or do you feel unsteady while standing or walking?
  3. Do you use durable medical equipment (DME)?
  4. Are you interested in increasing the amount you exercise?

Exclusion Criteria:

* Inability to read and understand the English language.
* Psychological or other disability resulting in the inability to provide informed consent.
* Unstable medical comorbidity that precludes safe participation in an exercise program, in the judgment of the clinical investigator.
* Prisoners and other institutionalized individuals.
Effects of Emotional Processes on Speech Motor Control in Early Childhood Stuttering.

This study will compare speech variability between preschool-age children who stutter and typically fluent, age-matched peers. Differences in emotional reactivity, regulation and speech motor control have been implicated in stuttering development in children. This study seeks to understand further how these processes interact. Children will repeat a simple phrase after viewing age-appropriate images of either negative or neutral valence to assess speech motor control.

Stuttering is a developmental disorder that emerges in the preschool years as children are undergoing rapid development of their speech, language, and emotional regulation processes. This study aims to understand how speech motor control and emotional processes interact in young children who do and do not stutter.

In Aim 1, the investigators will be observing how speech motor control and learning are affected by emotional (physiological) arousal. High arousal (e.g., stress) has been shown to disrupt highly skilled performances such as in sports and music performance (Yoshie et al., 2009). Parents of children who stutter often report that that exciting or stressful situations lead to increased stuttering in their children. There is little research, however, on how excitement or stress affects fluency in children.

In Aim 2, the investigators will observe how behavioral inhibition plays a role in speech motor control and motor learning in the context of emotional processes. Behavioral inhibition is one aspect of a child's temperament. Temperament refers to self-regulation as well as emotional, motor, and attentional reactivity that differs among individuals. Children with high behavioral inhibition (BI) are hyper-vigilant and more sensitive to new stimuli and negative emotional states. Therefore, the purpose of Aim 2 is to see if children with high BI are more susceptible to contextual emotional processes, therefore affecting speech motor control and learning.

Outcomes will be measured by calculating the variability in speech motor movements (STI). The two groups, children who stutter and age-matched peers who do not stutter, will be compared to see how speech motor control varies between groups and conditions.

Eligibility Criteria:
Inclusion Criteria:

1. English as the primary language of communication.
2. No history of neurological diseases or diagnosed speech-language disorders apart from stuttering.
3. Parent report or direct observation of oral-facial structural abnormalities (such as cleft lip and/or cleft palate).
4. Free of any medications that may affect neural functions (e.g., medications of seizures).
5. Normal hearing acuity (must pass a hearing screening).
6. Normal vision per parent report.

Exclusion Criteria:

1. Failure to meet the inclusionary criteria listed above
2. Parental report of neurodevelopmental disorders (such as autism spectrum disorders)
3. Parental report of vision problems that are not corrected or corrected with glasses.
Tweens to Teens Project at Penn State

The goal of this study is to help investigators to understand more about the development of characteristics related to being male or female (what is called gender development). The investigators will study girls with congenital adrenal hyperplasia (CAH) aged 10 to 13 to learn more about the girls' interests and activities, thoughts and feeling about being female, and family relationships. This will help investigators to understand the ways in which gender development is shaped by hormones and family relationships.

Interviewers will visit girls in their home when it is convenient for the family. Girls will answer questions about the things they do and are interested in, how they think and feel, and complete some cognitive tasks. Girls will also provide saliva so we can examine their hormones and determine the CAH gene mutation they have. Parents will also be asked to complete questionnaires about their own activities and interests and about their daughter's behavior.

Shortly after the home visit, interviewers will telephone girls and their parents on several days and ask what the girls did during the day.

Eligibility Criteria:
Inclusion Criteria:

* Girls with classical or non-classical CAH due to 21-OHD
* Girls will be aged 10-13 years at initial recruitment
* Parents will include biological mothers and fathers as well as step-parents and/or other guardians/significant caregivers
* Parents/guardians may range in age from 18 years of age to 65 years of age.

Exclusion Criteria:

* Girls who are not within the age range of 10-13 years old at initial recruitment
* CAH not due to the 21-OHD form
Vivistim Registry for Paired VNS Therapy (GRASP)

The purpose of the Vivistim Registry for Paired VNS Therapy (GRASP) is to gather real-world information on patients with arm and hand deficits post-stroke who are considering Vivistim System treatment. Before and after Vivistim System implant, patient data will be collected and reported throughout the therapy process. Physicians or sites will receive appropriate remuneration for the effort and cost involved in collecting and transmitting this data to MicroTransponder Inc.

The registry is a data repository of information on patients considering implant of the Vivistim System. The Vivistim System is an FDA approved (P210007) device used to help improve upper limb motor deficits after a stroke. Most patients entered into the registry will go on to be implanted with the System although those who decide not to move forward with the implant procedure can still have data collected as a non-implant comparison group (as long as either or both FM-A / WMFT assessments were collected). The primary purpose of the registry is to provide real-world usage and outcomes data on the Vivistim System. The patient outcome registry will collect acute and long-term follow-up data on Vivistim implanted patients treated with Paired Vagus Nerve Stimulation (Paired VNS™) post-FDA approval.

Historical and implant information as well as quality of life information will be gathered on patients who consider implant of the Vivistim® System. Data will be collected at baseline, 3, 6, and 12 months after implantation, as well as yearly thereafter for up to three (3) years post-implant. Patients who decide not to have the Vivistim System implanted can continue to have data collected for comparison purposes.

Contributing sites and physicians will have access to their own site data and can have anonymized summary analyses on all aggregated data; sites will not have access to other sites' individual level data. Physicians can then use the above information to facilitate patient selection and treatment. Publication (oral or written) of data in the registry, other than individual site data, will not be permitted without the express written advance approval of MicroTransponder, Inc. and the other physicians contributing to the dataset.

Eligibility Criteria:
Inclusion Criteria:

* Patients implanted with the Vivistim System for upper limb deficits associated with an ischemic stroke

Exclusion Criteria:

* Not eligible for surgery
Evaluation of Digital Follow up of Preterm Infants

The aim is to study how a digital follow up tool can identify the preterm born children and their families who need further support or clinical interventions

This study runs a digital follow up parallel to clinical follow up, up to 2 years of corrected age of the child. It evaluates the ability of the digital follow up tool to identify the problems in growth and health, eating and feeding, neurodevelopment and parental wellbeing which require further support or interventions. This study includes all infants born under 34 weeks of gestation in Turku University Hospital during years 2019-2022 and those preterm children born under 32 weeks of gestation who turn to 2 years during years 2019-2021.

Parent satisfaction about the digital follow up tool is asked at each time point and anonymously once per year. The follow up age points are the expected day of birth, 1 month, 2 months, 4 months, 8 months, 12 months, 18 months and 24 months after the expected birth date.

Eligibility Criteria:
Inclusion Criteria:

* Children born before 34 weeks fo gestation and their parents
* Clinical follow up at Turku University Hospital

Exclusion Criteria:

* Parents do not speak Finnish, Swedish or English
Ipratropium Spray for Drooling Saliva in Parkinson's Disease

A phase II double blind clinical trial investigating the effects of ipratropium spray versus placebo spray in patients with Parkinson's disease.

Background: Excessive drooling of saliva (sialorrhoea) is a common complication of Parkinson's disease (PD). Unfortunately current medications, which rely on anticholinergic properties, often induce systemic side effects, such as confusion, hallucinations or urinary retention.

Aim: We therefore hypothesise that local application of an anticholinergic aerosol spray into the mouth would reduce sialorrhea in PD without inducing systemic side-effects.

Method: A double blind, randomised, placebo-controlled cross-over trial of the muscarinic antagonist, ipratropium bromide in patients with bothersome drooling in idiopathic Parkinson's disease. All patients are recruited from the Movement Disorders Clinic, Toronto Western Hospital and informed consent is obtained. Patients are randomised to receive ipratropium bromide, 1- 2 metered doses (sprays) of active drug (21 micorgram per metered dose) or matching placebo, up to a maximum of 4 times per day, in a double-blind, cross-over design using randomisation tables. Total treatment length is two weeks for each limb of the study with a 1-2 week wash out period. The primary outcome measure is an objective measure of saliva production. Dental rolls are inserted into the mouth for 5 min and the patient instructed not to swallow and sit upright. The weight of dental rolls before and after insertion is calculated as a measure of saliva production. The secondary outcome measures are subjective measure of saliva where patients or caregivers record the level of saliva production each day for the 2 weeks of each treatment using validated subjective rating scales which assess drooling severity and frequency. In addition, parkinsonism is rated using the UPDRS parts I - IV and adverse events are recorded. The scores for measured saliva production following ipratropium bromide and placebo treatment will be compared using appropriate paired t-tests. Results from the scales assessing the subjective measures of saliva production and UPDRS ratings will be compared via paired non-parametric Wilcoxon matched pairs test. 20 patients will be recruited.

Eligibility Criteria:
Inclusion Criteria:Male and female patients with idiopathic PD and who are currently experiencing bothersome drooling (United Parkinson's Disease Rating Scale (UPDRS) item 6, rating of 2 or higher) will be eligible for this study. Patients must be on a stable medication regimen for the preceding one-month run-in period. In addition, patients or a caregiver must be able to complete a daily record card, and patients must be able to tolerate an oral dental roll for 5-minute periods for saliva measurements.

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Exclusion Criteria:

Patients taking acetylcholinesterase inhibitors, cholinergic agents, or anticholinergic agents, history of glaucoma, clinically significant urinary outflow obstruction or urinary retention, active psychosis or hallucinations, and allergy to peanuts or soybeans. -