cyrilzakka/clinical-trials huggingface dataset:
Remote Access to Care, Everywhere, for Parkinson Disease

The primary objective of this study is to evaluate the feasibility, efficacy and the value of providing care to individuals with Parkinson disease directly into their homes. The specific aims are:

1. To demonstrate the feasibility of conducting remote evaluations of patients with Parkinson disease nationally;
2. To measure the impact of remote care on each patient's ability to improve his or her quality of life (QoL) and better manage his or her Parkinson disease; and
3. To assess the long-term acceptability to patients in receiving ongoing care remotely via telemedicine.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 30
* Self reported diagnosis of idiopathic Parkinson disease
* Ability to converse in English
* Ability and willingness to provide informed consent and complete study requirements
* Access to a non-public computer or similar devices with broadband internet.
* Located in New York, Maryland, Delaware, California, or Florida at time of virtual visit (or veterans with Parkinson disease anywhere in the U.S.)

Exclusion Criteria:

* Any condition (e.g.prominent psychosis) that in the investigator's or coordinator's judgment would preclude participation.
* Concurrent enrollment in another telemedicine study.
A Study to Evaluate the Safety and Effectiveness of Trastuzumab Emtansine (T-DM1) as Therapy in Chinese Participants With HER2 Positive Advanced Breast Cancer

This study is a post-marketing, observational, multicenter, prospective study. It will investigate the the safety and effectiveness of T-DM1 in the Chinese population in real-world clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with HER2-positive, unresectable locally advanced or metastatic breast cancer before the start of T-DM1 treatment
* Had prior treatment for breast cancer which must contain a taxane and trastuzumab
* Get the treatment of T-DM1 for the first time after diagnosis of breast cancer

Exclusion Criteria:

* Patients not receiving treatment for HER2-positive breast cancer with T-DM1 according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling
* Has been previously treated with T-DM1 before current clinical visit
* Currently participating in any clinical trials
* Previously participated in any clinical trials investigating anti-HER2 drug within 1 year of the initiation of T-DM1
Effect of Breathing Maneuvers on Peripheral Glucose Metabolism

Two important mechanisms play a major role in the pathogenesis of type 2 diabetes: insulin resistance of the target tissues and the impaired insulin secretion from pancreatic β-cells. Postprandial factors (such as insulin) are perceived by the human brain and induce signals that regulate glucose metabolism via the parasympathetic nervous system.

Deep breathing exercise can increase parasympathetic nerve activity. Heart rate variability (HRV) in healthy people can be significantly increased by deep breathing maneuvers, indicating a shift from sympathetic activity to parasympathetic activity.

The hypothesis is that this postprandial shift results in a change in peripheral glucose metabolism. In turn, the increased parasympathetic activity could potentially result in a change in postprandial insulin sensitivity or secretion.

To test this hypothesis, this study investigates the effect of deep breathing exercise versus normal breathing on insulin sensitivity, on insulin secretion, glucose tolerance, resting energy expenditure, and on parasympathetic tone (analysis of heart rate variability).


Eligibility Criteria:
Inclusion Criteria:

* HbA1c \<6.5%
* Must be able to understand the explanations of the study and the instructions

Exclusion Criteria:

* Any relevant (according to investigator's judgment) cardiovascular disease
* Neurological and psychiatric disorders
* Diabetes mellitus
* Asthma
Microsleep 1, Micro-sleep During Maintenance Wakefulness Tests

During general anesthesia, intraoperative hypotension (IOH) is associated with increased morbidity and mortality. Mean arterial pressure (MAP) \< 65mmHg is the most common definition of hypotension. In order to reduce IOH, a complex method using machine learning called hypotensive prediction index (HPI) was shown to be superior to changes in MAP (ΔMAP) to predict hypotension (MAP between 65 and 75 excluded). Linear extrapolation of MAP (LepMAP) is also very simple and could be a better approach than ΔMAP. The main objective of the present study was to investigate whether LepMAP could predict IOH during anesthesia 1, 2 or 5 minutes before.

Hypothesis : the area under the ROC curves (ROC AUCs) at 1, 2 and 5 minutes of LepMAP would be superior to AMAP

Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from sleep pathologies (apneas, narcolepsy, etc.) hospitalized for polysomnography and MWT, in order to evaluate their sleepiness (usually before they resume driving)
* hospitalized in the Center for Sleep Medicine (Hôpital Lyon Croix Rousse) between September 2017 and January 2019

Exclusion Criteria:

* patient with active encephalopathy or epilepsy whose EEG was abnormal
* denial of study participation
* availability of all the recordings (n=4 tests) of the MWT
Transcutaneous Electrical Spinal Cord Stimulation for Lower Limbs

This study is to determine if non-invasive electrical stimulation of the spinal cord can be used to: 1) assess spared function following a spinal cord injury; and 2) be use for rehabilitation.

This study is to determine if non-invasive electrical stimulation of the spinal cord can be used to: 1) assess spared function following a spinal cord injury; and 2) be use for rehabilitation.

The investigators hypothesize that this type of stimulation can be used to locate and determine if any spinal (nerve) pathways or connections were spared following a spinal cord injury. We also hypothesize the same stimulation can help revive or recover function to muscles connected to these spared spinal (nerve) pathways in individuals who are clinically paralyzed. Our research has demonstrated that modifying the activation state of the spinal cord after an injury, or awakening the spinal cord, can benefit people with paralysis years after a spinal cord injury. This method and device have not yet been approved by the FDA for the treatment of paralysis and are under investigation. This study if successful will help provide further evidence that could be use to one day to gain FDA approval.

Eligibility Criteria:
Inclusion Criteria: SCI ASIA A, B, C

* Spinal cord injury 1 or more years prior
* Non progressive cervical or thoracic SCI
* Half of key muscles below neurological level having a motor score of less than 2/5
* Ability to commit to home exercises and 16 week participation
* Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate participation in lower extremity rehabilitation or testing activities
* Not dependent on ventilation support
* No painful musculoskeletal dysfunction, unhealed fracture, pressure sore, or urinary tract infection that might interfere with lower extremity rehabilitation or testing activities
* No clinically significant depression or ongoing drug abuse
* Adequate social support network to be able to participate in weekly training and assessment sessions for the duration of the 16 week study period
* No current anti-spasticity regimen
* Must not have received botox injections in the prior six months
* Be unable to use lower extremity for functional tasks

Exclusion Criteria:

* Pregnancy
* No functional segmental reflexes below the lesion
Comparison of Post-Operative Pain Occurrence After Single Visit Root Canal Treatment

The goal of this clinical trial is to compare the post-operative pain occurrence after single visit root canal treatment using Two NiTi Rotary Files. The main question it aims to answer is:

• Does an instrument design and instrumentation technique could affect postoperative pain incidence and intensity? Researchers will use ProTaper Universal rotary system or M-Pro rotary system for root canal preparation and compared postoperative pain intensity.

Participants will receive single visit endodontic treatment using either ProTaper or MPro systems for root canal preparation.

Participants will record Pain intensity at 24 hours and 7 days post-operative. Analgesics will be prescribed for the patients in need.

The main cause of patient fear is expecting pain during root canal treatment. It is considered a major concern for dentists as well. During root canal preparation, periapical extrusion of pulpal tissue remnants, microorganisms or dentin chips may be one of the causes of postoperative pain. Depending on the fact that, instrument design and instrumentation techniques have an impact on the amount of extruded debris apically, many studies proved the ability of some rotary systems to reduce debris extrusion, permitting to achieve less pain sensation.

Therefore, the present clinical study aims to compare the postoperative pain intensity in molars with symptomatic irreversible pulpitis after single endodontic treatment visit using a full-sequence rotary Ni-Ti system either ProTaper or MPro systems Eighty patients with symptomatic irreversible pulpitis in mandibular first molars will be assigned into two groups. In group A (n=40): root canal preparation will be performed in single visit using ProTaper Universal system and in group B (n=40): root canal preparation will be performed in single visit using M-Pro rotary system. Pain intensity will be recorded by the patient using Numerical Rating Scale (NRS) at 24 hours and 7 days postoperative. Analgesics will be prescribed for the patients in case of need.

Eligibility Criteria:
Inclusion Criteria:

* Patient's diagnosis is symptomatic irreversible pulpitis in mandibular first molar.
* Males and females patients in a good health.
* Aged from 25 to 45 years old.
* Pulp vitality is confirmed with cold pulp test and an electric pulp test.

Exclusion Criteria:

* Pregnant females.
* Patients complaining from pain in more than one molar on the same side.
* Patients whose teeth react positively to percussion test.
* Patients who receive analgesics 12 hours before the start of the root canal treatment.
* Teeth having grade 2 or 3 mobility.
* Presence of periapical radiolucency or teeth with extra oral or intraoral sinus tract or fistula.
Pacifiers and Breastfeeding Among Mothers at Risk for Postpartum Depression

We will enroll 40 mother-infant dyads in a randomized trial exploring the effect of distribution of pacifiers during the birth hospitalization to mothers at high risk for postpartum depression on pacifier use, infant feeding, and maternal stress.

This study is a pilot a randomized controlled trial to determine if pacifier distribution affects breastfeeding among mothers at high risk for postpartum depression. We will recruit 40 mothers of healthy singleton births in a U.S. hospital who are at high risk of postpartum depression and randomly assign them to receive a pacifier or not. We will ascertain pacifier use, maternal stress, and infant feeding behaviors with web-based surveys at 2, 4, 6, 12, 18, and 24 weeks. Mothers will also wear a wristband to detect maternal heart rate variability throughout the first 6 weeks as a marker of maternal stress.

Eligibility Criteria:
Inclusion Criteria:

* Breastfeeding mother/infant dyad, receiving postpartum care at UC Davis Medical Center, maternal personal or family history of depression or postpartum depression, mother 18-45 years of age, infant 12-72 hours of age

Exclusion Criteria:

* infant without congenital anomalies that could affect feeding (cleft lip/palate, chromosomal anomaly, micro or retrognathia), infant preterm (born prior to 37 weeks' gestation), mother unable to participate in English, infant admitted to the neonatal intensive care unit, No smart phone
Safety and Efficacy of BHV-3000 (Rimegepant) Orally Disintegrating Tablet for Acute Treatment of Temporomandibular Disorders

The purpose of this study is to compare the efficacy and safety of rimegepant versus placebo in the acute treatment of Temporomandibular Disorders (TMD), which are medical conditions involving the temporomandibular joint (the joint connecting the jawbone to the skull) and surrounding muscles and tissues.


Eligibility Criteria:
Inclusion Criteria:

\* Subject has a minimum 3-month to a maximum 5-year history of temporomandibular disorder diagnosed by a healthcare provider.

* At least one instance of pain ≥ 6 on a Numeric Rating Scale (NRS) (0-10) in the jaw and/or temple area on either side in the past 30 days prior to the Screening Visit.
* Subject agrees to study-required restrictions of new pain medication, injection therapy, oral devices, occlusal splint therapy or any other pain management techniques during the course of the study.
* Subject agrees to study-required birth control methods during the course of the study and female subjects must not be breastfeeding.
* No clinically significant abnormality identified on the medical or laboratory evaluation.

Exclusion Criteria:

\* Subject has an exclusionary headache, joint, pain, connective tissue, or developmental disorder.

* Subject has an exclusionary history of trauma, surgery, or radiation treatment to the head and neck.
* Body Mass Index ≥ 33kg/m2.
* Subject history of exclusionary medical conditions such as HIV disease, cardiovascular conditions, uncontrolled hypertension or diabetes, psychiatric conditions, drug or alcohol abuse, malignancies, drug allergies, or any significant and/or unstable medical conditions.
* Subjects taking/using excluded therapies.
* Participation in clinical trial with non-biological investigational agents or investigational interventional treatments.
* Subjects who have previously participated in any BHV-3000/ BMS-927711/ rimegepant study.
* Planned participation in any other investigational clinical trial while participating in this clinical trial.
Turkish Version of Lower Extremity Functional Scale in Elders

This study was conducted in order to analyze the validity and reliability, and psychometric properties of the Turkish version of the Lower Extremity Functional Scale (LEFS-T) in elder adults. The LEFS was translated and cross-culturally adapted to Turkish. Totally 214 elders were included in the study. The LEFS-T, Five-Times-Sit-to-Stand Test (FTSTS), and Falls Efficacy Scale International (FES-I) were applied to all older adults. Item-total correlations of factors and Cronbach alpha internal consistency coefficients were determined to examine the reliability. The relationship between the LEFS-T, FTSTS, and FES-I was analyzed. Exploratory (EFA) and confirmatory factor analysis (CFA) were used for construct validity. Spearman Correlation Analysis was used for concurrent validity. Davis technique was used to calculate the content validity index. Floor and ceiling effect were calculated. It has been concluded that the LEFS-T has good psychometric qualities and can be recommended as a choice of measurement tool to assess self-reported physical functioning in elder adults.

Purpose: This study was conducted in order to analyze the validity and reliability, and psychometric properties of the Turkish version of the Lower Extremity Functional Scale (LEFS-T) in elder adults.

Method: The LEFS was translated and cross-culturally adapted to Turkish. Totally 214 elders were included in the study. The LEFS-T, Five-Times-Sit-to-Stand Test (FTSTS), and Falls Efficacy Scale International (FES-I) were applied to all older adults. Item-total correlations of factors and Cronbach alpha internal consistency coefficients were determined to examine the reliability. The relationship between the LEFS-T, FTSTS, and FES-I was analyzed. Exploratory and confirmatory factor analysis were used for construct validity. Spearman Correlation Analysis was used for concurrent validity. Davis technique was used to calculate the content validity index. Floor and ceiling effect were calculated.

Eligibility Criteria:
Inclusion Criteria:

* Being 65 years old and older, and ability to speak and read Turkish fluently.

Exclusion Criteria:

* Having neurological, cognitive, and communication problems that can affect the lower extremity functionality severely, and elder adults who cannot answer questionnaires due to inability to understand.
Efficacy Of Pencil Pushup Exercise Vs Base Out Exercising Prism's In Patient With Convergence Insufficiency

Convergence insufficiency (CI) is a prevalent binocular vision disorder that leads to symptoms such as eye strain, headaches, and blurred vision during near work. This study aims to evaluate and compare the efficacy of pencil pushup exercises versus base-out exercising prisms in the management of CI. A Randomized Controlled Trial (RCT) will be conducted with 28 participants, using non-probability convenience sampling from SIGHTON Optix, Lahore. Participants will be randomly assigned to either the experimental group (receiving base-out exercising prisms) or the control group (receiving pencil push up exercises). The study will assess symptom improvement using the Convergence Insufficiency Symptom Survey (CISS), near point of convergence (NPC).

The study will also evaluate quality of life (QoL) using a vision-related QoL questionnaire. The total study duration is 3 months, with a primary goal of determining the relative efficacy of these two interventions. This study is expected to provide valuable insights into effective, evidence-based management options for convergence insufficiency, ultimately improving patient outcomes and guiding clinical practice. The collected data will be analysed by using SPSS.

Eligibility Criteria:
Inclusion Criteria:

* Patients having CISS score more than 16 or higher for children aged \<21 and 21 or higher for adults.
* Patients diagnosed with convergence insufficiency based on clinical tests (e.g., near point of convergence).
* Age group: 10-50
* Patients experiencing symptoms related to convergence insufficiency, such as eye strain, headaches, blurred vision, or double vision during near work.
* Able to perform pencil push-up exercises correctly after demonstration.
* No other significant ocular or neurological conditions that might affect vision or convergence.

Exclusion Criteria:

* Any type of strabismus.
* Amblyopia.
* Refractive error more than 6 diopters.
* Patients with history of prism prescription.
* History of strabismus surgery or refractive error surgery.
* History of eye trauma.
* Any systemic and neurological diseases affecting binocular vision such as diabetes, myasthenia gravis, Graves', and multiple sclerosis.
Computer-Based Therapy for Mild Cognitive Impairment

The purpose of this study is to determine the neuropsychological and neurophysiological impacts of a computer-based training program designed to improve the cognitive performance of patients with mild cognitive impairment (MCI).

The study is a randomized, double-blind, controlled trial of a computerized, cognitive intervention with three main goals: 1) to assess the magnitude of improvements in memory, language function, and cognitive function following computer training, 2) to investigate the neurophysiological mechanisms underlying such neuropsychological improvements, and 3) to demonstrate the feasibility of using this kind of computer-based therapy in older populations.

Eligibility Criteria:
Inclusion Criteria:

1)65 - 90 years of age 2)Meet definition for MCI including complaints of cognitive decline as indicated by patient report and/or informant report, and corroborated by clinician judgment and, the absence of dementia, defined as impairment of memory and at least one other domain of cognitive function.

3)Fluency in English 4)Willing to meet the time commitment of the study

-

Exclusion Criteria:

1. Clinically significant cerebrovascular disease
2. Individuals scheduled to begin acetylcholinesterase inhibitor (AChEI) therapy -
The Effect of Using Clinical Guidelines on Kangaroo Care on Newborn and Maternal Outcomes

The aim of this study was to determine the effect of the use of clinical guidelines in kangaroo care (KB) practice on neonatal and maternal outcomes in premature infants.

The study was a single-blind, parallel group (experimental-control), randomized controlled experimental design with pretest-posttest design.

It was carried out in the neonatal intensive care unit of Selçuk University Faculty of Medicine Hospital in Konya province. Study data were collected from 40 premature newborns between September 2022 and November 2022. Premature infants in the intervention (n = 20) and control groups (n = 20) were determined by randomization method.

Kangaroo care was applied to the intervention group with the Kangaroo Care Guide created by reviewing the current literature, and kangaroo care was applied to the control group with the standard kangaroo care method of the clinic. Data were collected using the Descriptive Information Form, Physiological Parameters Form, Neonatal Comfort Behavior Scale, Nurse-Parent Support Scale, Parental Satisfaction Scale and Kangaroo Care Guide/Checklist for Infants Without Respiratory Support.

Premature infants were followed up with skin-to-skin contact with their mothers in kangaroo care for 65 minutes. In the study, physiological parameters and Neonatal Comfort Behavior Scale scores of premature infants and Nurse-Parent Support Scale and Parental Satisfaction Scale scores of mothers were evaluated. Pearson Chi-Square Test, Yates Correction and Fisher's Exact Test were used to compare categorical data according to groups. Two Independent Sample t Test was used to compare normally distributed variables and Mann Whitney U Test was used to compare non-normally distributed variables. Statistical significance level was accepted as p˂0.05.

Eligibility Criteria:
Inclusion Criteria:

For premature infants;

* The baby is born before 36+6 weeks of gestation
* Stability of vital parameters at the time of application,
* Stable health status (cardiorespiratory stability, no congenital or chromosomal abnormalities, no history of intraventricular hemorrhage, no history of periventricular leukomalacia and NEC, no systemic and metabolic disorders),

For mothers;

* Willingness to participate in the research
* Being able to read and write Turkish

Exclusion Criteria:

For premature infants;

* Being connected to a mechanical ventilator
* Congenital or chromosomal abnormality
* Being with deprivation syndrome
* Having a history of intraventricular hemorrhage

For mothers; Not being willing to care for kangaroos

- Having a physical disability to care for kangaroos