cyrilzakka/clinical-trials huggingface dataset:
Analytical Validation of Wrist-Based Assessment of Nocturnal Scratch in Atopic Dermatitis and Psoriasis

Pruritis is a common symptom in patients with atopic dermatitis and psoriasis. Patients with atopic dermatitis and psoriasis often report pruritis-associated sleep impairments and scratching behaviors during nighttime and the negative impact on their quality of life. However, nocturnal scratch behavior and sleep impairment are poorly understood due to the difficulties in quantifying these symptoms in patients' daily lives. This study deploys multiple technologies (polysomnography, video capture, wrist sensors, clinician-reported outcomes, and patient-reported outcomes) to develop and validate a wrist-based solution to quantify nocturnal scratch.


Eligibility Criteria:
Inclusion criteria for participants with atopic dermatitis:

* At least 14 years old
* Less than 70 years old
* Clinical diagnosis of Atopic Dermatitis
* Peak Pruritis NRS score \> 1

Inclusion criteria for participants with psoriasis:

* At least 18 years old
* Less than 70 years old
* Clinical diagnosis of plaque psoriasis
* At least a peak pruritis PNRS of 4
* Itch is caused by psoriasis, as determined by clinician

Exclusion Criteria:

* Non-Atopic Dermatitis or Psoriasis-related sleep disorder (e.g., diagnosed sleep apnea, restless leg syndrome etc...)
* Movement disorder
* Flare or infection on the wrist
* Infected atopic dermatitis or psoriasis lesions
* Pregnant or lactating women
* Shift workers or participants with jetlag
* Current diagnosis of depression
Remodelling After Trampoline Fracture in Children

The anterior tilting of the proximal tibia epiphyseal plate is a radiological tool for the diagnosis of suspected trampoline fracture. The tibial fracture leads to a ventral tilting of the tibial Plateau. This study is to document the long-term follow-up of the anterior tilt angle and to verify, if there is an uplift of the tibia plateau with correction of the anterior tilt angle to normal values (= remodelling) in order to guarantee optimal treatment of this rare fracture.


Eligibility Criteria:
Inclusion Criteria:

* trampoline fracture of the proximal lower leg

Exclusion Criteria:

* proximal tibial fractures with unclear etiology
Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

A Randomized, Double-Blind, Parallel-Group, 52-Week, Chronic-Dosing, Multi-Center Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Eligibility Criteria:
Inclusion Criteria:

Given their signed written informed consent to participate. Must have agreed to participate in and complete the lead-in Study PT010006.(NCT02497001)

Exclusion Criteria:

Severe osteoporosis Unable to achieve an acceptable DEXA scan Inability to achieve pupil dilation to at least 6 mm Subjects with an implanted artificial intraocular lens or are scheduled to undergo cataract surgery
A Retrospective Study on Drug Induced Liver Injury in China

This is a multi-center, open-enrollment, retrospective, non-interventional epidemiologic study without any clinical treatment. Its primary objective is to understand 1) incidence of drug-induced liver injury, including incidences among all the hospitalized patient, among patients in department of hepatic diseases, digestive diseases, oncology, hematology etc., individually; 2) epidemiologic characteristics of drug-induced liver injury, including suspected medications, clinical types, histological characteristics, severity and outcomes.

This is a multi-center, open-enrollment, retrospective, non-interventional epidemiologic study without any clinical treatment. Its primary objective is to understand 1) incidence of drug-induced liver injury, including incidences among all the hospitalized patient, among patients in department of hepatic diseases, digestive diseases, oncology, hematology etc., individually; 2) epidemiologic characteristics of drug-induced liver injury, including suspected medications, clinical types, histological characteristics, severity and outcomes.

It investigates medical records of patients who were hospitalized during 2012 to 2014. Those patients should be diagnosed as drug-induced liver injury, drug-induced liver disease, drug-induced hepatitis, drug-induced hepatocirrhosis, drug-induced hepatic failure, or any other similar diagnosis of drug-induced liver injury nature.

Eligibility Criteria:
Inclusion Criteria:

* Any hospitalized patients who were diagnosed as drug-induced liver injury, drug-induced liver disease, drug-induced hepatitis, drug-induced hepatocirrhosis, drug-induced hepatic failure, or any other similar diagnosis of drug-induced liver injury nature.
* The drug-induced liver injury and similar diagnosis were not excluded the possibility of drug-induced nature.

Exclusion Criteria:

* Confirmed non-drug induced liver injury.
* Insufficient clinical data supporting the diagnosis of drug-induced liver injury.
* Liver injury resulted from poisons and chemicals.
Assessment of Cardiac Function, Microvascular Function and Cardiac Perfusion in Different Disease Stages of Hypertrophic Cardiomyopathy

Hypertrophic cardiomyopathy (HCM) is a genetic disorder characterized by asymmetric hypertrophy of the heart in absence of loading conditions like hypertension. The genetic mutation underlying HCM sets in motion a cascade of functional and metabolic changes ultimately leading to disease. HCM patients often have microvascular dysfunction and myocardial perfusion deficits, of which the aetiology has not been elucidated. Whether these changes are secondary to remodelling or primarily caused by endothelial dysfunction is unclear. As the pathomechanism of HCM is thought to be a cascade of changes, it is important to gain more insight in the perfusion and endothelial function changes throughout different stages of disease: no phenotype, mild phenotype, and advanced HCM phenotype. In this study we aim to investigate these changes in the two most common genetic mutations.


Eligibility Criteria:
Inclusion Criteria:

One of below:

* MYBPC3 mutation carrier
* MYH7 mutation carrier
* Genotype-negative first degree relative of a MYBPC3 or MYH7 mutation carrier

All of the following criteria:

* For the mutation carrier group: ≥18 years old
* For the genotype-negative group: ≥30 years old

MYBPC3 and MYH7 mutation carriers will be designated to one of three groups based on their maximum wall thickness, measured by echocardiography and MRI:

* No phenotype: MWT \<12mm
* Mild Phenotype: MWT ≥12 until \<15mm
* HCM phenotype: MWT ≥15mm

Exclusion Criteria:

* ≥70 years old
* Insulin-dependent diabetes mellitus
* Pregnancy
* Smoking
* Claustrophobia
* Pacemaker/ICD
* Renal insufficiency \<30 GFR
* Hypertension (systolic \>140mmHg or diastolic \>90mmHg)
* For the genotype negative group, no phenotype group, and mild phenotype group: the use of blood pressure medication (diuretics, beta-blockers, ACE-inhibitors, angiotensin II receptor blockers, calcium channel blockers, alpha blockers)
* For the HCM phenotype group: when it is unsafe to withhold from blood pressure medication (as specified above) for two days, as assessed by their own cardiologist
* Left ventricular outflow tract gradient \> 50mmHg
* Aortic valve disease
* Left bundle branch block
* (History of) Obstructive coronary artery disease
* Chronic atrial fibrillation
* Hormone replacement therapy
* Second or third-degree AV-block, sick-sinussyndrome, prolonged QT-interval
* Asthma and other obstructive pulmonary diseases
* Previous adverse reaction to adenosine or dotarem
Implications of the Human Microbiota for Health and Disease

The purpose of this study is to advance the understanding of human health and disease as it relates to environmental factors that may affect intestinal and non-intestinal microbiota.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years of age or older
* Able to provide informed consent

Exclusion Criteria:

* None
Is There a Relationship Between the Risk of Injury and Posture in Wrestlers?

This study was planned to investigate the relationship between the risk of injury and posture in wrestlers. The study will be included male wrestlers. The spine posture and flexibility of the athletes will be measured during standing position with the Idiag M360® brand Spinal Mouse (SM), while the overall body posture will be measured from the anterior and lateral sides using the New York Posture Analysis Method (NYPAM). Injury risks of the athletes will be evaluated by Functional Movement Screen (FMS) which was consisting of seven basic movement patterns.


Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18 and 40
* To be a professional wrestler who won medals in the Turkey championships

Exclusion Criteria:

* had injury for in the last 6 months
* had a history of surgery, or chronic and progressive disease
* had any orthopaedic or neurological problems
Evaluating the Efficacy and Safety of Oral Ranirestat (40 and 80 mg) in Mild to Moderate Diabetic Sensorimotor Polyneuropathy

The purpose of this study is to determine the effect of 40 mg and 80 mg ranirestat on peroneal motor nerve conduction velocity relative to placebo in subjects with mild to moderate diabetic sensorimotor polyneuropathy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with Type 1 or Type 2, insulin-dependent or non insulin-dependent diabetes mellitus.
* Subjects with a history of distal symmetric polyneuropathy, secondary to diabetes, diagnosed in accordance with the American Academy of Neurology criteria.
* Female subjects, who are of non-reproductive potential (\>=12 months post-menopausal or surgically sterile) or who are using adequate contraception which includes abstinence or double barrier methods (diaphragm and condom with spermicidal cream, intrauterine device and condom with spermicidal cream). Male subjects with partners of child-bearing potential must also use adequate contraception.
* Subjects must be able to read, understand, and provide written informed consent before enrolling in the study at screening.

Exclusion Criteria:

* History of diabetic foot ulcers or lower extremity amputation.
* Diabetic amyotrophy or non-diabetic cause of lower limb neuropathy/neuropathic symptoms.
* Clinically significant illness which, in the opinion of the investigator, would compromise a subject's suitability to participate in the study for reasons of safety or would confound the efficacy assessments.
Preoxygenation With High-flow Nasal Oxygen in Adult Trauma Patients During Rapid Sequence Induction Anaesthesia

Previous studies investigating apnoea oxygenation has shown that delivering oxygen via a high flow can maintain adequate oxygen saturation levels in a patient for over 30 minutes.

It has recently been demonstrated, in several studies, that High Flow Nasal Oxygen (HFNO) used during preoxygenation in patients undergoing emergency surgery is at least equally effective as preoxygenation with standard tight fitting mask. Data from these recent studies investigating arterial oxygen saturation levels during rapid sequence induction anaesthesia have not been able to detect any difference between the two methods. The mean apnea time among the patients in the previous studies have been relatively short.

Patients suffering traumatic injuries could be more prone to desaturate during prolonged apnea due to being hemodynamic unstable or suffering injuries to the respiratory tract.

Based on the above, the aim is now to conduct a trial where trauma patients are preoxygenated with high flow nasal oxygen before anaesthetised with rapid sequence induction (RSI) technique. The trial is set to be a before-and-after study. During approximately 6 to 9 months data will be registered from trauma patients undergoing emergency anaesthesia where preoxygenation is performed according to standard rutin, with traditional facemask. During the coming six to nine months trauma patients undergoing emergency anaesthesia will be preoxygenated with high flow nasal oxygen. Data will be registered and compared to the data collected from the patients preoxygenated with facemark.

The general purpose of this project is to compare the preoxygenation technique based on HFNO with traditional preoxygenation with a tight fitting mask, with the main focus being oxygen saturation levels, during rapid sequence induction (RSI) intubation in trauma patients in need of immediate anaesthesia.


Eligibility Criteria:
Inclusion Criteria:

* 1 Adult, ≥18 years old
* 2 Level 1 trauma with patients in need of emergency anaesthesia before leaving the trauma unit (trauma room or nearby operating theatre).

Exclusion Criteria:

* 1 Patients with or with risk of skull or facial injuries where application of nasal cannula is decided to be avoided by the trauma team.
Internet-Based Depression Screening for College Students

This study aims to determine whether using telecommunication tools, specifically web pages containing online screening instruments and real-time video chat, will be an efficient way to implement Major Depressive Disorder screening among college students. The study also aims to determine if proactive depression screening and free online consultation with a psychiatrist will increase the rate of help-seeking among college students with MDD.

Eligible participants will complete a demographics survey and depression screening assessment online. Those subjects who express suicidality or depressive symptoms will be offered the opportunity to complete a one-time psychiatric consultation with Skype video-conferencing.


Eligibility Criteria:
Inclusion criteria:

* All who consider themselves current undergraduate from Massachusetts colleges are encouraged to participate.
Multimodal Fetal and Placental Imaging and Biomarkers of Clinical Outcomes in Opioid Use Disorder

The goal of this observational study is to learn about the long term effects of prenatal opioid exposure. The main objectives are:

* Long term goal: to improve the safety and efficacy of maternal Opioid Use Disorder (OUD) and eliminate neonatal opioid withdrawal syndrome (NOWS) and poor childhood neurodevelopment.
* To characterize prenatal opioid exposure (POE) related placental and fetal brain structural and functional disruptions using longitudinal placenta-fetal brain magnetic resonance imaging (MRI) and determine proteomic, genomic, and epigenetic signatures of NOWS and poor infant neurodevelopment.

In this study participants will:

* Receive two placental-fetal MRIs, one during second trimester and one in third trimester.
* Answer surveys relating to their medical and social history.
* Have blood drawn during pregnancy and delivery.
* Child development follow up: answer surveys on their child's development milestones and at one year of life they will undergo a development assessment.


Eligibility Criteria:
Pregnant women with opioid use disorder

Inclusion Criteria:

* Age \>18 years
* Currently taking buprenorphine or methadone for OUD and are enrolled in a prenatal opioid maintenance program
* Singleton Pregnancy
* Planned delivery at Indiana University or University of Pittsburgh study sites

Exclusion Criteria:

* Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures
* Known or suspected major fetal/ neonatal congenital abnormalities
* HIV or AIDS

Infants with prenatal opioid exposure:

Inclusion:

1. Prenatal buprenorphine or methadone exposure
2. Born to mother enrolled in Opioid Use Disorder arm of study

Exclusion:

Major congenital anomalies or genetic syndromes affecting neurodevelopment

Control Pregnant Women:

Inclusion:

1. Women \>18 Years of age
2. Healthy singleton pregnancy
3. Planned delivery at Indiana University or University of Pittsburgh study sites

Exclusion:

1. Serious maternal medical illness as deemed by study physician investigators that would make it challenging to comply with study procedures
2. HIV or AIDS
3. Known or suspected major fetal congenital abnormalities
4. Any history of opioid misuse before or during pregnancy-per self-report and clinical notes.

Control infants:

Inclusion:

Born to control pregnant mother enrolled in study

Exclusion:

Any major congenital anomalies, genetic abnormalities, neurologic abnormalities, syndromes, or chronic medical conditions affecting neurodevelopment.
Safety and Tolerability of Dalfampridine in Subjects With Cerebral Palsy

A double-blind, placebo-controlled, crossover study in subjects with cerebral palsy (CP) to evaluate the safety and tolerability and the effect of dalfampridine extended release (ER) tablets on sensorimotor function


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of CP
* No previous use of any dalfampridine formulation
* Ability to perform all the required study procedures. Subjects should be capable of fully extending and flexing both hands

Exclusion Criteria:

* Presence of any progressive neurological disease
* Severe CP defined as the requirement to use a wheelchair at all times and a care taker for constant assistance in daily activities. This definition includes spastic quadriplegia
* Pregnant or breastfeeding
Pectoral Nerves Blocks for Chronic Pain

The purpose of this study is to determine whether pectoral nerves blocks（PECS） would reduce chronic pain at 3 months after modified radical mastectomy（MRM）surgery.

One hundred and forty adult female participants scheduled for elective unilateral modified radical mastectomy under general anesthesia are randomly allocated to receive either general anesthesia plus Pecs block(Pecs group, n=70) or general anesthesia alone (control group, n=70).

After arrived in the operating room，the participants in the control group are accepted the general anesthesia.Whereas，after anesthesia induction，the participants in the Pecs group receive an ultrasound-guided Pecs block and a 15 minute observation time prior before the start of the operation.

Pecs block technology： A broadband (5-12 hertz) linear array probe of Sonosite Edge portable ultrasound system (Sonosite Inc,Bethel,Washington) is used, with an imaging depth of 4 to 6 cm. After cleaning the infraclavicular and axillary regions with chlorhexidine, the probe is placed below the lateral third of the clavicle, similar to what is done when performing infraclavicular brachial plexus block. After recognition of the appropriate anatomical structures, the skin puncture point is infiltrated with 2% lignocaine, then the block is performed by using a 20-gauge Tuohy needle. The needle is advanced to the tissue plane between the pectoralis major and pectoralis minor muscle at the vicinity of the pectoral branch of the acromiothoracic artery, and 10 mL of 0.35% ropivacaine deposited. In a similar manner, 20 mL is deposited at the level of the third rib below the serratus anterior muscle with the intent of spreading injectate to the axilla.

Eligibility Criteria:
Inclusion Criteria:

* Modified radical mastectomy
* American Society of Anesthesiologists physical status 1-3
* BMI 18-35 kg/m2

Exclusion Criteria:

* Declining to give written informed consent；
* Uncontrolled hypertension；
* Allergy to local anesthetics；
* Pregnancy；
* Alcohol or drug abuse；
* Prior breast surgery except for diagnostic biopsies；
* Contraindication to the use of regional anesthesia；
* History of chronic pain or psychiatric disorder and pregnant patients；
* Consumption of NSAID, cyclooxygenase-2 inhibitors or paracetamol within 24 hours before the investigation；
* Infection at the needle site.
* Inability to properly describe postoperative pain to investigators (eg, language barrier, neuropsychiatric disorder)
Questionnaire for Obstetricians and Anesthesiologist

The research was planned as a face-to-face survey evaluation. The questionnaire will be applied to obstetricians and anesthesiologists working in public and private hospitals. The universe of the research will be selected by simple random sampling method, and the total number of people who will participate is planned to be 200, approximately 100 from each of the two branches. Our survey consists of 5 parts structurally. Demographic data, rate of cesarean section and postpartum hemorrhage, uterotonic agent preferences in low/high risk cesarean section surgeries, the preference for second-line uterotonic agents, and the dose preferences of uterotonic agents.


Eligibility Criteria:
Inclusion Criteria: obstetricians and anesthesiologists who want to participate in the survey

Exclusion Criteria: the ones who do not want to participate

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Blood Flow Restriction in Improving Muscle Strength of Patients With Hemophilic Knee Arthropathy

Background. The main physical sequela of patients with hemophilia is the development of a progressive, degenerative intra-articular lesion, known as hemophilic arthropathy). This sequela is manifested by chronic pain, limited range of motion, axial abnormalities, and periarticular muscle atrophy.

Objective. To assess the safety and effectiveness of an intervention through blood flow restriction, regarding the frequency of bleeding and the improvement in muscle activation and strength, range of motion, functionality, joint pain, joint status and the perception of quality of life in patients with hemophilic arthropathy. knee and ankle.

Study design. Randomized, multicenter, single-blind clinical study. Method. 60 patients with hemophilia A and B will be recruited in this study. Patients will be recruited in 6 regions of Spain. The dependent variables will be: bleeding frequency (self-registration), pain (measured with the visual analog scale and pressure algometer), quality of life (SF-36 scale), joint status (Hemophilia Joint Health Score scale), strength (dynamometer) and muscle activation (surface electromyograph), range of motion (goniometer) and functionality (Timed up and go test). Three evaluations will be carried out: pre-treatment, post-treatment and after a follow-up period of 4 weeks.

Expected results. Observe the safety of blood flow restriction in hemophilia patients. To analyze the efficacy of blood flow restriction in improving muscle strength and activation, range of motion, chronic pain, functionality, and the perception of quality of life in patients with hemophilic knee and ankle arthropathy.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with hemophilia A and B
* People with a medical diagnosis of hemophilic knee arthropathy
* Adults (\> 18 years)
* In prophylactic treatment regimen or on demand with FVIII/FIX concentrates.
* Failure to sign the informed consent document

Exclusion Criteria:

* Patients with neurological or cognitive alterations that prevent understanding of the questionnaires
* Amputee patients, epileptics or patients with severe vision problems
* Patients who are receiving physiotherapy treatment at the time of the study