cyrilzakka/clinical-trials huggingface dataset:
Brain Activity, Cognitive Function, and Walking Ability in Parkinson's Disease

The dual-task automated walking performance in people with Parkinson\&#39;s disease (PD) is affected by their gait disturbances and impaired executive functions. Currently, the relationship between brain activity related to inhibitory control, executive functions, and dual-task walking performance in people with PD is not well understood. Therefore, this study aims to investigate the significance of different executive function domains on gait stability in healthy older adults and people with PD; whether brain activation related to inhibitory control is associated with gait stability in healthy older adults and people with PD.


Eligibility Criteria:
Inclusion Criteria:

* Diagnoses of idiopathic Parkinson disease
* Stable dopaminergic medicine ≥ 2 weeks
* Able to walk 10 meters without aid
* Mini-Mental Status Examination ≥ 24 points
* No uncorrected visual or auditory disorders
* Education at least junior high school
* No other disease may affect balance

Exclusion Criteria:

* Other medical diagnoses of neurological, musculoskeletal, or cardiopulmonary disorders
* History of brain surgery (e.g. deep brain stimulation)
A Noninferiority Study of Alglucosidase Alfa Manufactured at the 160 L and 4000 L Scales in Treatment Naïve Patients With Infantile-Onset Pompe Disease

A study to demonstrate comparable safety, efficacy, and pharmacokinetics (PK) of alglucosidase alfa manufactured at the 160 litre (L) and 4000 L scales in participants who had been diagnosed with infantile-onset Pompe disease. Participants were treated with alglucosidase alfa 160 L scale product in the United States (US) and 4000 L scale product in the regions outside the US.


Eligibility Criteria:
Inclusion Criteria:

* The participant's parent/legal guardian was willing and able to provide signed informed consent.
* The participant might be less than or equal to 12 months of age.
* The participant might have documented GAA enzyme deficiency from blood, skin, or muscle tissue.
* The participant might be naïve to treatment with alglucosidase alfa.

Exclusion Criteria:

* The participant was cross-reactive immunologic material negative.
* The participant required invasive ventilator support at the time of enrollment.
* The participant had decompensated clinical heart failure.
* The participant had a major congenital abnormality, excluding cardiac hypertrophy.
* The participant had a clinically significant organ disease (excluding the signs and symptoms of Pompe disease).
* The participant was currently receiving any investigational product.
* The participant was participating in another clinical study.
* The participant and/or the patient's parent/legal guardian was unable to adhere to the requirements of the study.
Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions

The purpose of this study is to compare the outcomes of two uterine-conserving treatment alternatives for symptomatic uterine fibroids: laparoscopic myomectomy (LM) and global fibroid ablation (GFA) using the Halt System. Laparoscopic ultrasound (LUS) is a standard step prior to the GFA procedure but has not been a standard step prior to LM. Incorporating laparoscopic ultrasound as a first step prior to both treatments allows the surgeon to have equal access to valuable imaging information and to plan treatment accordingly. By randomizing the subject immediately after laparoscopic ultrasound, selection bias toward one treatment or the other following the LUS is eliminated.


Eligibility Criteria:
Inclusion Criteria:

* Are ≥ 18 years old and menstruating
* Have symptomatic uterine fibroids
* Have a uterine size ≤16 gestational weeks as determined by pelvic exam
* Have fibroids that are less than 10 cm in any diameter
* Desire uterine conservation
* Have had a normal Papanicolaou test (PAP smear) (i.e. PAP I or PAP II) at the latest pre-study examination and no longer than 36 months before study entry.
* Are willing and able to comply with all study tests, procedures, and assessment tools
* Are capable of providing informed consent.

Exclusion Criteria:

* Have contraindications for laparoscopic surgery and/or general anesthesia.
* Are expected to be high risk for, or are known to have, significant intra-abdominal adhesions (defined as adhesions that would require extensive dissection to mobilize and view all surfaces of the uterus)
* Patients requiring major elective concomitant procedures (e.g., hernia repair, hysteroscopic resection, endometrial ablation, uterine artery ligation, etc.) that could confound the results of the study
* Are pregnant or lactating
* Have taken any depot Gonadotropin-releasing hormone (GnRh agonist within three months prior to the screening procedures
* Have an implanted intrauterine or fallopian tube device for contraception that cannot or will not be removed at least ten days prior to treatment
* Have chronic pelvic pain not due to uterine fibroids
* Have known or suspected endometriosis or adenomyosis
* Have active or history of pelvic inflammatory disease
* Have a history of, or evidence of, gynecologic malignancy or pre-malignancy within the past five years
* Have had pelvic radiation
* Have a non-uterine pelvic mass over 3 cm
* Have a cervical myoma
* Have one or more completely intracavitary submucous fibroids (Type 0) or only Type 0/1 submucous fibroids that are better treated via hysteroscopic methods
* In the medical judgment of the investigator should not participate in the study
* Are not willing to be randomized to treatment.
Project Movement/Daily Move Feasibility

The purpose of this study is to test the feasibility (acceptability and demand) of the Daily Move in a diverse sample of US adults. Acceptability benchmarks: 214 participants recruited within three months (60% will identify as a racial/ethnic minority; 30% African American, 30% Hispanic); At least 70% of participants rate the intervention as satisfactory. Demand benchmarks: At least 70% of participants complete 75% of prescribed Daily Move sessions per week across the 8-weeks; Dropouts not to exceed \>30% of participants. Aim 2 - explore the pre-post trends in change of: Stress - Perceived Stress Scale (PSS), Anxiety and Depression - Hospital Anxiety and Depression Scale (HADS), Mindfulness- Mindful Attention Awareness Scale (MAAS), and Mood- Profile of Mood States (POMS).

Generalized stress among adults is an increasingly problematic concern, particularly in recent years due to the COVID-19 pandemic. According to the Stress in America 2020 data, Americans are still struggling to cope with the disruptions that the pandemic has caused, and nearly 8 in 10 adults (78%) say that the COVID-19 pandemic is a significant source of stress in their life. This stress from the COVID-19 pandemic is in addition to previous sources of stress that impacted American adults, including things such as health care, mass shootings, global climate change, and more. Additionally, rising concerns over racism and racially-driven acts of violence has impacted racial-ethnic minorities and led to rising rates of stress over discrimination. In 2021, 44% of people of color said that discrimination was a significant source of stress in their life, compared with 38% back in 2019. The currently proposed study aims to include American adults with elevated levels of stress, with 60% of the recruited sample targeting racial-ethnic minorities.

The investigators have previously conducted multiple feasibility and pilot studies investigating the use of the mobile meditation app, Calm, on various mental health outcomes in a diverse range of adults (cancer patients, adults with sleep disturbances, etc.). The investigators have found the Calm meditation app to be both feasible and beneficial for adults on a range of mental health outcomes, including stress-related outcomes. Although there is a growing body of evidence to describe the benefits of short, daily meditations on stress and other mental health outcomes in adults, there are currently no investigations that have been done to examine the feasibility or impact of short, daily app-based mindful movement exercises on stress in adults. It is for these reasons that the primary purpose of this study is to test the feasibility of the Calm's "Daily Move" component on stressed adults.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Score of 6 or greater on the Perceived Stress Scale-4

Exclusion Criteria:

* Subscribe to Calm or use Calm
* Live outside of the United States of America
* Unable to read or understand English
A Pilot Study Examining the Efficacy of Biomodulator Treatment for Chronic Low Back Pain

The purpose of this study is to determine the efficacy of self treatment with the Biomodulator device to decrease chronic low back pain (LBP) in active duty service members. In addition, the study will track the use of pain medication and the impact of pain on symptoms of anxiety, depression and Post Traumatic Stress Syndrome (PTSD).


Eligibility Criteria:
Inclusion Criteria:

* active duty Service Members (SMs) between the ages of 18 and 62, inclusive
* history of chronic LBP (i.e. intermittent or continuous LBP symptoms present for 3 months or greater prior to entry into the study
* participants must be using narcotic and/or non-narcotic oral analgesic medications to treat their chronic LBP symptoms on a weekly basis
* must be able to speak and read English and understand the study procedures

Exclusion Criteria:

* pacemaker or implanted electronic device
* history of stroke, blood clots, or cardiac arrhythmias
* pregnancy
* no self-reported history of prescription medication abuse or sole-provider contract for prescribed narcotic medications
* open wound over site of chronic pain;
* history of spinal surgery
* participation in a clinical trial for an investigational drug/ treatment within last 30 days
* undergone treatment with TENS, biofeedback, or acupuncture within last 30 days
* prior treatment with the Biomodulator
* LBP "red flags": fever, trauma, progressive motor or sensory deficit, saddle anesthesia
* participation in the study would delay the medical board (MEB) processing of the service member off of active duty status or would delay a return to duty status to their home unit
Stress Response Pathways in Vitiligo

The purpose of this study is to investigate stress response pathways in tissues and melanocytes from patients with vitiligo. Investigators are collecting evidence of UPR and stress response activation in tissues and melanocytes from patients with vitiligo. Individuals with vitiligo will have punch biopsies to study stress response UPR activation and NF-κB signaling to test our hypothesis. In order to characterize differences between disease and normal states, a second arm of control individuals (Arm 2) will be recruited.

Identifying a role for NF-κB signaling in vitiligo may improve therapies for this disfiguring disorder. Current treatments vary in effectiveness and may not always be long lasting cases. The NF-κB pathway and IL-6 itself are the target of several FDA approved drugs, thus opening new therapeutic avenues.

Eligibility Criteria:
Inclusion Criteria:

* To be eligible for participation, subjects must meet all of the following criteria:
* Must have a clinical exam consistent with and diagnosis of non-segmental vitiligo
* Must be normally pigmented
* No clinical presentation of vitiligo

Exclusion Criteria:

* Outside of the specified age range
* No clinical diagnosis of vitiligo
* Use of systemic therapies, including but not limited to methotrexate, etretinate, or cyclosporine, calcineurin inhibitors and/ or vitamin D analogs within 4 weeks of enrollment
* Use of topical steroids or topical immunodilators at biopsy site within 4 weeks of enrollment
* History of keloids or hypertrophic scars
* Patients with pacemakers or defibrillators or heart valves
* Patients on Plavix, Warfarin or similar anticoagulation medicine
* Pregnant females
* Lactating women
* Allergies or sensitivity to lidocaine or epinephrine
* Outside of the specified age range
* Abnormally pigmented at potential biopsy sites (non-vitiligo)
* Clinical presentation of vitiligo
* Use of systemic therapies, including but not limited to methotrexate, etretinate, or cyclosporine, calcineuron inhibitors and/ or vitamin D analogs within 4 weeks of enrollment
* Use of topical steroids or topical immunodilators at biopsy site within 4 weeks of enrollment
* History of keloids or hypertrophic scars
Morphologic Study of the Intersegmental Plane After Fully Thoracoscopic Segmentectomy

The objective of this study is to determine whether stapling adversely affects the pulmonary parenchyma and the vascularisation of the adjacent segments. The aim of our work is to explore by thoracic densitometry with contrast the spared segments after stapling of the intersegmental plan following a thoracoscopic segmentectomy, 3 or 6 months post-surgery. the investigator will assess venous drainage and the arterial vascularisation of the remaining segments, possible modifications of the adjacent parenchyma and whether there is a defect of pleuro-pulmonary adhesion (residual pneumothorax).

Scheduled anatomical segmentectomies are increasingly popular, due to the development of minimally invasive techniques, the increased incidence of early-stage tumours, and the possibility of caring for patients with compromised health and/or limited respiratory function without compromising the oncological outcome, compared to current alternatives such as stereotactic ablative radiotherapy (1).

One of the challenges in the development of the thoracoscopic segmentectomy technique we have published (2-5) is the orientation (6-7) and the division of the intersegmental plane, by contrast to segmentectomy by thoracotomy where this is helped by palpation and the manual traction which can be used on the segment, along the intersegmental vein. The most commonly used technique to separate two adjacent segments remains stapling, despite its high cost and sometimes giving a less anatomical section, with a risk to encroach on the intersegmental vein. Moreover, there can be a partial plicator of the spared segment(s) which could in theory make them less functional.

We have however shown that the postoperative morbidity and mortality rates were much lower than that of patients who had a thoracotomy, dropping from 42% for thoracotomies to 16% for thoracoscopies, the surgical approach being an independent predictive factor for postoperative complications (8).

Eligibility Criteria:
Inclusion Criteria:

* Enrolment in the study will be offered to all patients having undergone a programmed scheduled video-assisted thoracoscopic segmentectomy, whatever the aetiology.
* Men or women aged 18 years or greater
* Absence of severe hepatic insufficiency
* signed and dated informed consent
* candidate for segmentectomy
* Registration in a national healthcare system.
* Women of child-bearing age using effective oral or barrier contraception

Exclusion Criteria:

* Proven intolerance to iodinated contrast agents
* Know allergy or non-controlled asthma - pregnancy
* Severe hepatic insufficiency (creatinine clearance \< 30ml/min, by Cockroft's method)
* Pregnant or breastfeeding women
* Patients under trusteeship or curators
* Diabetic patients or patients receiving oral antidiabetic medication
AI-Driven Genotype Prediction Using EHR and Multimodal Data

The goal of this clinical study is to explore the potential of using electronic health records (EHR) and multimodal data (such as imaging, lab results, and clinical history) to predict a patient's genotype. The study will evaluate whether predictive models based on this non-genetic data can accurately infer genetic information, which traditionally requires direct genetic testing.

This multi-center, retrospective clinical study aims to evaluate the use of electronic health records (EHR) and multimodal data (such as clinical lab results, imaging data, and medical history) in predicting a patient's genotype. The primary objective of the study is to develop an AI-based prediction model that can infer genetic information by analyzing available health data, eliminating the need for direct genetic testing.The AI model will be trained to process and integrate large datasets, including EHR, lab results, and imaging data such as X-rays, MRIs, and ultrasounds, in order to predict genotypic information. The study will compare the AI-based predictions to actual genetic testing results to evaluate the accuracy of the model. If successful, this method could provide a non-invasive, cost-effective tool for genotype prediction, which could be used in personalized medicine, early disease diagnosis, and risk stratification.Participants will not undergo any genetic testing as part of the study. Instead, their historical medical data will be analyzed by the AI system to predict genetic information and associated disease risks. The study will assess the model's ability to predict genetic predispositions to various health conditions based on the available health data. By doing so, the study aims to advance the use of AI in clinical decision-making and genetic diagnostics.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must have comprehensive electronic health records (EHR), including medical history, lab results, and relevant imaging data (e.g., X-rays, MRIs, CT scans).
2. Participants must have existing genetic testing data available for comparison, if applicable.
3. Participants must be willing to provide consent for the use of their health data in the study.
4. Participants must have no active intervention related to genetic testing or prediction during the study period.
5. Participants should have complete and verifiable health data to allow for accurate prediction by the AI model.

Exclusion Criteria:

1. Participants without available EHR, lab results, or imaging data.
2. Participants with ambiguous, inaccurate, or unverifiable genetic testing results that cannot be used for comparison.
3. Patients with significant discrepancies or missing data that would prevent the AI model from making accurate predictions.
Proof of Concept Trial to Confirm That the Recovery of Patients Treated in the Intensive Care Unit Requiring Mechanical Ventilation is Beneficially Affected by the Environmental Simulation of Daytime and Night Time Alternation as Well as by the Nutrition Protocol Corresponding to the Daily Rhythm

The purpose of this study is to determine whether the environmental simulation of daytime and night time alternation as well as by the nutrition protocol corresponding to the daily rhythm are beneficially affect the recovery of patients treated in the Intensive Care Unit (ICU) requiring mechanical ventilation.

The homeostasis of human body is significantly disturbed when organs' work-relax periods are not harmonized. Intensive Care Unit (ICU) patient's circadian rhythm is almost inevitably upset as a result of their disease and/or medical intervention. There are numerous animal studies prove that circadian rhythm and periodic dynamics are directly related to healing time and hence, mortality rate. Although, one of the main messengers of circadian synchronization is melatonin, it is overridden by temperature, and a number of other factors from e.g. the digestive tract. If the circadian rhythm is disturbed, the function of different organ systems becomes desynchronized and chaotic.

ICU environment and patient-care activities brings major drawbacks as well mainly by necessary presence of noise and light. It has been shown that ICU settings have an impact on patients' sleep, which can easily lead to delirium and circadian disruption. There are significant data showing strong correlation between delirium and ICU length of stay/ mortality.

The focus of this study is the environmental modulation at the ICU with controlled light, noise and nutrition conditions. Controlled light conditions are created with artificial light during daytime and sleeping mask during night time. Earplugs are used during night time for controlled noise conditions. Nutrition is carried out only during daytime both in case of enteral and parenteral feeding.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years or older
* Requiring treatment at the intensive care unit including mechanical ventilation
* Admission at the intensive care unit was done within 24 hours before randomization
* Written and signed patient information sheet and informed consent form obtained by the study participant or by his/her legal representative

Exclusion Criteria:

* Traumatic brain injury
* Multiple trauma
* Severe damage of the eye/optic nerve
* Blindness
* Post CPR
* Unlikely to survive 24 hours
* Involvement of the central nervous system (trauma, bleeding, infection, ischemia, etc.)
* Intracranial space occupying process
* Increased intracranial pressure
* Narcolepsy
* Huntington's disease
* Hypothermia
* Pregnancy
The Effect of Different Microprocessor Knee Prostheses on Mobility and Gait Parameters in Transfemoral Amputees

Microprocessor knee joints are prosthetic knee joints with an integrated processor or a computer that can analyze data. During walking, parameters such as step speed, joint angles, and weight transferred through sensors are analyzed by the computer inside the joint and determines the movement for the safest and most normal walking. They have different features from each other in terms of weight/height, sensor and processor frequency, load carrying capacity, phase control (hydraulic, pneumatic, magnetic), battery properties, water resistance, and special activity mode. C-Leg, Genium, Genium X3, Rheo Knee 3, Rheo Knee XC, Orion etc. prostheses of different companies are used as oscillating and compression phase microprocessor knee prostheses.

Publications on C-leg, Genium and Genium X3 prostheses are limited in international literature. Although there are existing studies comparing C-leg and Genium, there is no study comparing these three prostheses. The investigators think that our study is important because it is the first study in the literature to compare these three prostheses. In this study, the investigators aimed to examine the effects of different microprocessor knee prostheses on mobility and gait parameters in unilateral traumatic transfemoral amputees.

The study will be carried out with patients who applied to the outpatient clinic or who received inpatient treatment in the orthopedic rehabilitation (amputee) clinic. The patient's demographic information (age, gender, height, weight, body mass index, education level, occupation, marital status) and clinical characteristics (amputation date, cause of injury, amputation side, etc.) will be recorded with the evaluation to be made to the patient. The activity levels of the patients will be evaluated by the Amputee Mobility Predictor, the mobility of the patients by the Locomotor Capacity Index, the prosthesis satisfaction in general with the visual analog scale (VAS), the walking ability and capacity with the prosthesis will be evaluated by the 2 min walking test, and the gait analysis will be evaluated in the motion analysis laboratory.

Eligibility Criteria:
Inclusion Criteria:

1. be over 18 age
2. Having a unilateral traumatic transfemoral amputation for at least 3 months
3. Using prosthesis for at least 3 months
4. Not having cognitive problems
5. Using your current prosthesis for at least 4 hours a day
6. No concomitant orthopedic problem in the contralateral lower extremity

Exclusion Criteria:

1. Under the age of 18
2. Presence of neurological, cardiovascular and pulmonary disease that may affect walking performance
3. Being inadequate in Turkish communication
4. Residual extremity skin loss
5. Using a walking aid