cyrilzakka/clinical-trials huggingface dataset:
Assessment of Orthopedic Care of the Z-shaped Foot in Infant

Real-life, observational, monocentric, ambispective study, carried out in France. The aim of the study is to evaluate the success rate of orthopedic management of the Z-foot after at least 9 months of follow-up.

The study will include a single prospective data collection, which will make it possible to obtain prospective clinical data at the longest follow-up after treatment, with a minimum follow-up of 9 months. This collection will be done during a visit to the office or a phone call, depending on the preference of patients and their parents.

Early data (before the intervention, immediately after, and at 3 months of follow-up) will be collected retrospectively in medical records.

Eligibility Criteria:
Inclusion Criteria:

* Child having presented a congenital idiopathic malformation uni- or bilateral of foot in Z, defined by the presence of an angular adduction of the mid-forefoot and a dorsolateral hump;
* Orthopedic treatment with femoropedic plasters and slotted splints in 1st intention, having started at least 9 months before inclusion;
* Child aged 6 months to 2 years at the start of care;
* Authorization of the parents or the legal representative of the child to collect personal information about their child.

Exclusion Criteria:

* Child having presented a secondary Z foot;
* History of foot surgery;
* Lack of retrospective data to assess the convexity of the external edge of the foot before orthopedic care;
* Inability of the parents or the child's legal representative to understand the study protocol.
Association of Transcranial Alternating Current Stimulation with Digital Cognitive Training for Cognitive Remediation in Older Adults

BACKGROUND Cognitive decline in older adults, especially those who develop Mild Cognitive Impairment and Alzheimer's Disease, currently has limited options of pharmacological treatments, with modest efficacy.

Digital Cognitive Training (DCT) and Transcranial Alternating Current Stimulation (tACS) are two promising tools for cognitive remediation in this population. In this exploratory study, we investigate feasibility, tolerability and preliminary effects of the association of both interventions in older adults with cognitive complaints.

METHODS Older adults with cognitive complaints are being enrolled for this study, which comprises 5 daily sessions of 30 minutes of DCT using the BrainHQ platform while simultaneously receiving theta tACS (6Hz, 1.6mA) targeting the Left Dorsolateral Prefrontal Cortex.

Our goals in this study are:

* To investigate the feasibility and safety of transcranial direct current stimulation (tDCS) adjunctive to cognitive training (CT) in a cohort of individuals diagnosed with mild cognitive impairment (MCI), Subjective Cognitive Decline or Alzheimer's desease in it's initial phase (CDR 1).
* To assess the efficacy of this combined intervention in modulating cognitive function, as measured by a comprehensive neuropsychological battery.
* To explore the underlying neural mechanisms of this intervention by examining changes in event-related potentials (ERPs), specifically the N200 and P300 components, which are sensitive to cognitive processes and neural plasticity.
* To identify potential peripheral biomarkers in serum that may correlate with cognitive decline and response to the intervention.
* To determine whether the combined intervention can induce lasting changes in neurophysiological markers, as assessed by repeated ERP measurements.
* To examine the relationship between the observed cognitive improvements, alterations in neurophysiological measures, and changes in serum biomarker levels, with the aim of elucidating the biological mechanisms underlying the intervention's effects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects over 50 years old, with cognitive complaints

Exclusion Criteria:

* Estimated Intelligence Quotient \<80
* Dependence on psychoactive substances (DSM-V)
* Severe psychiatric or neurological disorders
* Uncorrected visual/hearing problems
* History of syncope for an unexplained reason or seizure less than a year ago
* Previous stroke
* Use of anticoagulants
* Intracranial metallic prosthesis or cardiac pacemaker
* Any contraindication to performing tACS
SleepFlexTM Treatment of Obstructive Sleep Apnea

The purpose of this study is to evaluate the safety and effectiveness of the SleepFlex program for treatment of mild to moderate OSA


Eligibility Criteria:
Inclusion Criteria:

* Age 21 years and older
* Mild to moderate OSA, defined as AHI \>10 - 30 events/hour, documented by polysomnogram or home sleep apnea test within 180 days prior to study enrollment
* Central or mixed disordered breathing events (≤25% of total number of events)
* Unable to tolerate or decline positive airway pressure therapy
* Body mass index ≤32 kg/m2
* Able to protrude tongue ≥20 mm beyond maxillary incisors
* Absence of markedly enlarged tonsils, defined as 3+ or 4+ according to the Brodsky classification
* No uncontrolled sleep disorder other than OSA such as narcolepsy, chronic insomnia, restless legs syndrome, or REM behavior disorder
* Absence of excessive daytime sleepiness, defined by Epworth Sleepiness Scale score \>10
* No uncontrolled nasal obstruction
* Absence of moderate to severe mandibular insufficiency
* No previous surgery involving the oral cavity or pharynx other than tonsillectomy
* No previous radiation therapy to the head and neck
* No known neurologic, cardiac (other than hypertension controlled with a single medication), pulmonary, renal, hepatic, or psychiatric disorders
* No psychiatric diagnoses other than treated depression or mild anxiety
* Stable medication regimen for ≥1 month
* No acute illness or infection
* Ownership of personal smartphone with iOS or Android operating system
* No known hypersensitivity to any material of the SleepFlex devices

Exclusion Criteria:

* Unwilling or unable to provide informed written consent in English
* Pregnancy, breastfeeding, or plans to become pregnant
* Smoker (tobacco or recreational drugs) in the past month
* Alcohol consumption, averaged over the previous month, greater than 2 alcoholic beverages per day
* Significant vision or hearing problems
* Unwilling or incapable of returning for all follow-up visits and conduct sleep studies at home, including the evaluation procedures and filling out questionnaires
* Any other reason the investigator determines as being unfit for study participation
A Study of NB004 As Monotherapy or Combination Therapy in Patients with Advanced Solid Tumors

This is a Phase 1, Open-label, Multicenter Study to Assess the Safety, Tolerability, and Pharmacokinetics of NB004 Administered as Monotherapy or Combination Therapy in Subjects with Advanced Solid Tumors

This study is a Phase 1, open-label, multicenter study of NB004 administered orally in patients with histologically and/or cytologically confirmed diagnosis of advanced solid tumors that are metastatic for which all standard treatment options have been given and are ineffective, or is no longer eligible for additional standard treatment options.

The study is comprised of a dose escalation phase to determine the maximum tolerated dose and the RP2D and an expansion phase to further explore the safety and preliminary antitumor activity of NB004.

Eligibility Criteria:
Inclusion Criteria:

1. males or females of any race\>(=)18 years age.
2. Histologically and/or cytologically confirmed diagnosis of advanced solid tumors that are without standard treatment options (part 1).

   Pathologically confirmed locally advanced or metastatic solid tumors with KRAS G12C mutation as determined by a test that has been approved by FDA or local health authority (part 2\&3).
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Life expectancy\>(=)12 weeks.
5. Adequate organ and marrow function.
6. Measurable or evaluable disease.

Exclusion Criteria:

1. Prior anti-cancer therapy within 2 weeks or at least 5 half-lives, whichever is longer, up to a maximum of 3 weeks, before the first dose.
2. Toxicities from previous anti-cancer therapy that have not recovered as required.
3. Brain metastatic disease, spinal cord compression, or leptomeningeal carcinomatosis.
4. Active infection including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV):
5. Female subjects who are pregnant, or breastfeeding, or planning to become pregnant while in this study or within 3 months after the last dose.
6. Male subjects who plan to father a child while enrolled in the study or within 3 months after the last dose.
7. Received prior treatment with a PIM kinase inhibitor.
A Study of LY2944876 in Healthy Japanese and Non-Japanese Participants

LY2944876 is an investigative drug for the treatment of Type 2 Diabetes Mellitus. Part A of the study will assess the safety and tolerability of single doses of LY2944876 in Japanese participants. Participation is expected to last up to about 7 weeks, not including screening.

Part B of the study will investigate the safety and tolerability of multiple doses of LY2944876 in non Japanese participants. Participation is expected to last up to about 8 weeks, not including screening.

All doses will be administered as injections into the fatty layer just beneath the skin.

Screening is required within 28 days prior to the start of the study. All participants will attend a post study safety assessment approximately 6 weeks after their final dose.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or female participants
* Are first generation Japanese participants (Part A) or non-Japanese participants (Part B)
* Have a body mass index (BMI) of 18.5 to 30 kilogram per meter square (kg/m\^2), inclusive, for Part A and a BMI of 25 to 40 kg/m\^2, inclusive, for Part B at screening
* Have normal blood pressure and heart rate (after approximately 5 minutes supine and approximately 2 minutes standing) as determined by the investigator at screening

Exclusion Criteria:

* Have known allergies to LY2944876, related compounds or any components of the formulation, or history of significant atopy
* Have an abnormality in the 12-lead electrocardiogram (ECG) at screening and/or baseline that, in the opinion of the investigator, increases the risks associated with participating in the study
* Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
* Have a history of acute or chronic pancreatitis or elevation in serum lipase and/or amylase greater than 2 times the upper limit of normal (ULN) at screening and/or baseline
* Have known or ongoing psychiatric disorders considered clinically significant in the opinion of the investigator
* Have undergone any form of bariatric surgery
* Have fasting blood glucose levels greater than or equal to (≥) 7 millimoles per liter (mmol/L) \[≥126 milligrams per deciliter (mg/dL)\] at screening
* Have fasting triglycerides levels ≥300 mg/dL (3.4 mmol/L) at screening
* Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or an alanine transaminase (ALT) or aspartate aminotransferase (AST) levels greater than (\>) 2.5 times the ULN at screening and/or baseline
* Have used or intend to use medications that promote weight loss, within 3 months prior to screening, for the duration of the study
Blood Flow Restriction Exercise in Patients With an Achilles Tendon Rupture

The goal of this clinical trial is to gain insights into the effects of Blood Flow Restriction Exercise (BFRE) in patients with an acute Achilles tendon Rupture. The main questions it aims to answer are:

Is BFRE an effective adjunct to usual care when compared with only usual care? When is the optimal timing for initiating BFRE: In the early treatment stage or at the later stage after hospital treatment? Participants will receive an intervention comprising 12 weeks of BFRE as an adjunct to usual care.

* Either in the initial 1-12 weeks after Achilles tendon rupture, or
* In the following 13-24 weeks after Achilles tendon rupture

Researchers will compare the two groups at 13 weeks (3 months) to compare BFRE to usual care, and at 25 weeks (6 months) to compare the two time points for initiating BFRE (early vs. late).

This is an assessor-blinded, randomized, controlled multicenter trial with patients allocated 1:1 to one of two parallel groups, with follow-up times at weeks 13 and 25 after allocation.

Patients with an acute Achilles tendon rupture treated non-surgically are eligible for inclusion. All patients will receive a 12-week BFRE program, either in weeks 1-12 or 13-24 post allocation, as an add-on to usual care.

The BFRE program is performed three times weekly on the injured leg at 80% of the limb occlusion pressure required to restrict the arterial blood flow fully.

Outcome measures are assessed at baseline, week 13, and week 25 after allocation. The primary outcome at the week 13 follow-up is the Single-Leg Heel-Raise test which assesses the patient's ability to raise the heel of the injured leg a minimum of 2 cm. The primary outcome at the week 25 follow-up is the Achilles Total Tendon Rupture Score which assesses the patient's self-reported symptoms and physical activity.

During most of the initial trial phase (weeks 1-12), patients are treated at local hospitals, where recruitment, assessment, and randomization occur. Usual care at the hospitals consists of ankle immobilization with a gradual return to weight-bearing in the following weeks. In the latter half of the trial phase (weeks 13-24), patients have transitioned to municipal care, where usual care includes diverse exercises performed at home or training facilities.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or older
* have started initial treatment within 72 hours of Achilles tendon rupture
* understand written and spoken Danish

Exclusion Criteria:

* bilateral Achilles tendon rupture
* previous Achilles tendon rupture in either leg
* decreased lower extremity function, caused by conditions other than Achilles tendon rupture
* treated with fluoroquinolones within the last six months
* treated with corticosteroid injection(s) in the area near the Achilles tendon within the last six months.
* diabetes
* previous diagnosed thrombosis
* Known atherosclerosis in the peripheral arteries of the lower limb
* other reasons for exclusion (cognitive deficits, inability to provide informed consent, requiring cast-treatment due to low compliance regarding gradual wedge removal, etc.)
Improving Signout Accuracy and Information Delivery in the Emergency Department

The investigators sought to determine if implementing a standardized sign out process would reduce the amount of medical errors related to patient sign out. The standardized process included the following interventions: implementation of a data resident to review patients lab values, vital signs, radiologist results, and orders in real time, conducting sign out in a standardized location and using the attending physician as an "interruption manager." The investigators defined medical errors related to sign out as any piece of information was incorrectly reported or omitted during sign out that caused a change in treatment or disposition discussed during sign out. The investigators hypothesis was that implementing a standardized sign out process would lead to a decrease in the amount of sign out related errors.


Eligibility Criteria:
Inclusion Criteria:

* ED transfers of care occurring at 0700 or 1900.

Exclusion Criteria:

* Attending only handovers (1500, 2300)
* Handovers including midlevel providers (Thursday 0700, 1300).
EndoTAG-1 / Gemcitabine Combination Therapy to Treat Locally Advanced and/or Metastatic Adenocarcinoma of the Pancreas

The intention of this trial is to evaluate safety and efficacy of a combination treatment of EndoTAG-1 with Gemcitabine versus Gemcitabine monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Inoperable adenocarcinoma of the pancreas
* Histologic or cytologic confirmation
* At least 18 years of age

Exclusion Criteria:

* Any chemotherapeutical treatment for pancreatic adenocarcinoma before enrollment
* Major surgery within 4 weeks prior to enrollment
* Major cardiovascular disease
Relationships Between Toddlers With Feeding Disorder and SPD and Their Parents

The researched attends to observe the relationships between toddlers that were diagnosed as SPD and as having feeding disorder (by DSM-R-IV)and their parents.


Eligibility Criteria:
Inclusion Criteria:

* Toddlers aged between one year to two and a half years
* Toddlers diagnosed as SPD by occupational therapist
* Toddlers diagnosed as having feeding disorder by psychiatric physician according to DSM-R-IV
* Toddlers that are normally developed as reported by pediatrician

Exclusion Criteria:

* Compliant families
* Toddlers with poor health
Validity and Reliability of Lower Extremity Position Test in Patients with Multiple Sclerosis

Sensory disorders are one of the most important problems in individuals with MS, and these disorders are among the first symptoms of MS. Loss of sense of proprioception is particularly common in patients with MS. Studies show that assessment methods for the quantitative measurement of sensory disorders are lacking. Especially in the clinic, there is no evaluation method that evaluates the sense of proprioception. Therefore, the aim of this study perform the validity and reliability study of the lower extremity position test to evaluate proprioception sense in individuals with MS.


Eligibility Criteria:
Inclusion Criteria:

* 20-65 years old
* EDSS score between 0-5
* Person who has not had an attack in the last 1 month or who is not in the attack period
* Person without systemic disease such as hypertension, heart disease, Diabetes Mellitus, hyperlipidemia, malignancy
* Person who has not undergone surgery that restricts balance function in the lower extremity.
* Person without hip, knee and ankle contracture
* Person who does not have additional neurological disease
* Person who does not use vestibulosupressants or drugs that may cause neuropathy and does not have a history of alcohol use
* To have full cooperation and adaptation to the work
* Individuals who agree to receive treatment will be included in the study.

Exclusion Criteria:

* Being younger than 20 years old and over 65 years old
* Being in the attack period
* Hip, knee or ankle contracture
* Being greater than EDSS 5
* Having systemic diseases such as hypertension, heart disease, Diabetes Mellitus, hyperlipidemia, malignancy
* Having an additional neurological disease
* Having a vestibulospressant or drug or alcohol use habit that causes neuropathy
* Not cooperating and adapting to the work
SARS CoV-2 Infection and Inflammatory Biomarkers

Early research suggests that inflammation plays a key role in the development of SARS CoV-2 infection. The immune response to respiratory infection is characterized by an influx of neutrophils to the lungs. This study ought to investigate the association of simple biomarkers such as NLR and PLR with the clinical outcome in SARS CoV-2 infection patients.

Early research suggests that inflammation plays a key role in the development of SARS CoV-2 infection. The immune response to respiratory infection is characterized by an influx of neutrophils to the lungs. Moreover, previous studies have demonstrated that a sustained release of anti-inflammatory cytokines may lead to high levels of circulating neutrophils and lymphocytes' apoptosis with subsequent lymphopenia and immune response imbalance. Therefore, circulating biomarkers that represent inflammation and immune status could serve as potential predictors for the prognosis of SARS CoV-2 patients. The neutrophil to lymphocyte ratio (NLR) and platelet to lymphocyte ratio (PLR) are cheap and simply calculated biomarkers which have been identified as markers of systemic inflammation, severity of the disease and prognosis in several patient populations.

This study ought to investigate the association of simple biomarkers such as NLR and PLR with the clinical outcome in SARS CoV-2 infection patients.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with polymerase chain reaction (PCR) confirmed SARS CoV-2 infection

Exclusion Criteria:

* Patients aged\<18 years
Treatment of Hypertension With Two Exercise Intensities

To determine whether exercise training could significantly replace medication as a treatment for mild essential hypertension.

BACKGROUND:

Arterial hypertension affects over 50 million Americans. While drug treatment is effective, exercise would be safer, might be cheaper, and would bring added health benefits if it could replace drugs in controlling hypertension.

DESIGN NARRATIVE:

Randomized, controlled trial. Known hypertensives (n=162) whose diastolic blood pressures rose to between 90 and 104 within four months of discontinuing medication under careful observation had their pressures controlled with enalapril. Oxygen consumption (V02) peak was measured during cycle ergometry. Eligible subjects were randomly assigned to 18 months participation in one of three groups: 1) high intensity endurance training (35 minutes three times/week at heart rate at 70-85 percent of V02 peak), 2) moderate intensity endurance training (35 minutes three times/week at heart rate of 50-70 of V02 peak), and 3) contact control. Enalapril was forward or back titrated or discontinued to maintain a normal blood pressure. After 12 months participation, medication was withdrawn under careful supervision from all subjects still taking it. The trial tested the hypotheses that: 1) a greater number of subjects undergoing either or both of the two 18 month exercise training programs would be able to stop anti-hypertensive medication than non-exercising controls, 2) moderate and high intensity endurance training were equally effective in replacing drugs in the treatment of mild essential hypertension, and 3) subjects that were successful at withdrawing anti-hypertensive medication would have: greater improvements in V02 peak, better initial psychological status or greater improvements in psychological status, and greater compliance with the exercise training program.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria