cyrilzakka/clinical-trials huggingface dataset:
A Multi-Center Cohort Study of Risk Factors and Outcomes of Encephalopathy of Prematurity in China

The purpose of this study is to explore the perinatal risk factors of encephalopathy of prematurity and the morbidity of the following neurodevelopmental impairments in preterm infants with gestational age \<32 weeks in China.

Recent years have witnessed an increase in survival of very or extremely low birth weight infants, with a corresponding increase of attention to encephalopathy of prematurity (EOP) and the following neurological disorders. Studies suggested that hypoxic-ischemic injury and perinatal infection might be the two main risk factors of EOP, including white matter injury, neuronal-axonal diseases and cerebellar hemorrhage, which have a strong impact on neurological outcomes. Sequelae like cerebral palsy or mental retardation become a burden to both the family and society. Therefore, the risk factors of brain injury become the critical issue of both Obstetrics and Neonatology. More importantly, little is known about the morbidity of neurodevelopmental impairment and its risk factors in China. Thus, the aim of our study is to explore the perinatal risk factors of encephalopathy of prematurity and the morbidity of the following neurodevelopmental impairments in preterm infants with gestational age \<32 weeks in China.

Eligibility Criteria:
Inclusion Criteria:

* preterm infants with gestational age less than 32 weeks

Exclusion Criteria:

* major congenital malformations
* chromosomal disorders
* metabolic diseases
Addictive Threshold of Nicotine

To determine the nicotine threshold dose(s) for discrimination, subjective-rewarding effects, -and reinforcement in smokers with different levels of dependence.

The purpose of this project is to determine the nicotine threshold dose(s) for discrimination, subjective-rewarding effects, and reinforcement in smokers with different levels of dependence. Participants will have an Adaptation Session followed by 4 Test Days. The Adaptation Session will familiarize the participants with study procedures. In each Test Day, a different nicotine dose (0.1, 0.05, 0.025, and 0.0125 mg nicotine/pulse) will be compared to saline for nicotine discrimination, subjective effects, and reinforcement. Participants will first sample the assigned nicotine dose and saline, followed by 4 trials to test their ability to discriminate it from saline. This will be followed by 4 Choice trials where participants will be able to choose between nicotine (at the session-assigned dose) or saline to be administered by the research staff.

Reinforcement will be assessed with the percentage of nicotine choices during the Choice trials. The discrimination is the percentage of correctly identified nicotine and saline infusions. Rewarding effects will be assessed with the "Pleasurable Effects" composite score of the Drug Effects Questionnaire (DEQ).

Eligibility Criteria:
Inclusion Criteria:

* to contact their primary care provider when necessary.
* Adults, aged 21 to 59 years. Individuals less than 21 will be excluded because the minimum age for purchasing tobacco products is 21 in our state. The upper age is set at 59 because there are no previous IV nicotine studies that enrolled smokers over the age of 59.
* Smoking at least for one year and more frequently than once a week, smoking status confirmed with a semi-quantitative urine nicotine test. Smokers will be stratified based on the level of dependence, assessed with the FTND scores (Heatherton et al. 1991) (low or no dependence 4 and moderate or high level of dependence 5.
* In good health as verified by medical history, screening examination, and screening laboratory tests.
* For women, report using acceptable birth control methods.

Exclusion Criteria:

* History of major medical or psychiatric disorders that the physician investigator deems as contraindicated for the participant to be in the study
* regular current use of certain psychotropic medications (such as mood stabilizers, antipsychotics, or anxiolytics being prescribed to treat bipolar disorder, psychosis or anxiety spectrum disorders, respectively)
* current untreated alcohol or substance use disorder for any other recreational or prescription drugs other than nicotine
* for women, pregnant as determined by pregnancy screening, or breastfeeding
* seeking (or undergoing) treatment for tobacco dependence or smoking.
Navelbine And Radiotherapy in Locally Advanced Lung Cancer

This study is an open label randomized multi-centre phase II trial in patients with inoperable locally advanced stage IIB-IIIB Non Small Cell Lung Cancer who fulfils the general criteria for curatively intended irradiation. The treatment plan consists of two courses of inductions chemotherapy followed of concomitant therapy chemo-radiotherapy 3 weeks after day 1 of the last induction chemotherapy has been given. The patients will be included in the study after completing the induction chemotherapy. Randomization will take place only if an acceptable dose plan can be obtained.

This study was an open label randomized multi-centre phase II trial in patients with inoperable locally advanced stage IIB-IIIB Non Small Cell Lung Cancer who fulfils the general criteria for curatively intended irradiation. The treatment plan consisted of two courses of inductions chemotherapy followed of concomitant therapy chemo-radiotherapy 3 weeks after day 1 of the last induction chemotherapy has been given. The patients was included in the study after completing the induction chemotherapy. Randomization took place only if an acceptable dose plan could be obtained.

Primary endpoint: local recurrence free interval

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Patients with histologically or cytologically documented diagnosis of locally advanced NSCLC stage IIB to IIIB without pleural effusion
* Performance status 0-1 on the ECOG scale
* Weight loss ≤10% during the last 6 months
* Adequate lung function measured as FEV1 ≥1.0
* Neutrophile count ≥1.5 x 109/L and platelet count ≥100 x 109/L
* Serum bilirubin ≤1.5 upper limit of normal (ULN)
* ALAT ≤2 x ULN
* Able to comply with study and follow-up procedures
* Patients with reproductive potential must use effective contraception
* Written (signed) informed consent to participate in the study

Exclusion Criteria:

* Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, severe hepatic, renal, or metabolic disease)
* Any other active malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer)
* Prior chemotherapy for lung cancer, including neo- and adjuvant chemotherapy
* Inability to take oral medication, or requirement of intravenous alimentation
* Active peptic ulcer disease
* Nursing mothers
Comparison of In-lab PSG to WP200 for Assessing Sleep Parameters

The WP200 and/or WP200U will be compared with a PSG system which is a digital physiological recorder system, cleared for use for clinical sleep studies. The manual scoring of the PSG data, performed by a trained and authorized scorer, according to the AASM (American Academy of Sleep Medicine) guidelines, serves as a "gold standard" for all determinations of efficacy.


Eligibility Criteria:
Inclusion Criteria:

* Age between 12-17
* Subjects with a legal guardian that is able to read understand and sign the informed consent form
* Willing to sleep with the WP200/WP200U and PSG simultaneously in the sleep lab

Exclusion Criteria:

* Permanent pacemaker: atrial pacing or VVI without sinus rhythm.
* Use of one of the following medications: alpha blockers, short acting nitrates (less than 3 hours before the study)
Fabry Outcome Survey (FOS)

The purpose of this study is to collect data that will increase understanding of Fabry disease history and progression, in treated and untreated patients with Fabry disease. The data from FOS may provide guidance to healthcare professionals about disease treatment options.


Eligibility Criteria:
Inclusion Criteria:

1. Participants must have a documented diagnosis of Fabry disease

   * This may include a genetic mutation analysis. The collection of the genetic mutation analysis result is optional and dependent on the participant providing their consent for this data to be used in the FOS registry.
   * Participants can be untreated, currently or previously treated with Replagal, or any other approved treatment for Fabry disease.
2. Signed and dated written informed consent from the participant

   * For participants aged less than (\<) 18 years (or as per local regulation), parent and/or participant's legally authorized representative (LAR), and assent of the minor, where applicable, is necessary.
   * If a participant is unable to read or if a legally acceptable representative is unable to read, an impartial witness should be present during the informed consent discussion and should sign and personally date the informed consent.
   * Informed consent must be obtained from LARs for cognitively impaired participants when applicable.

Exclusion Criteria:

1. Participants currently enrolled in ongoing blinded clinical trials (drugs or devices; includes all blinded trials) will be excluded from the Registry.
Effectiveness of a Cancer Exercise Program

The investigators are examining the impact of an 8-week multi-modal exercise program (resistance and cardiovascular training) delivered 2 times per week on physical function adults (\>18 years old) with cancer.


Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 diagnosed with cancer

Exclusion Criteria:

* unwilling to come to the on-site clinic for exercise sessions
* any neuromuscular, cardiovascular, or psychological condition precluding safe exercise
* unable to read/understand English.
Isotonic Solution Administration Logistical Testing

The administration of intravenous crystalloids is ubiquitous in the care of the critically ill. Commonly available crystalloid solutions contain a broad spectrum of electrolyte compositions including a range of chloride concentrations. Recent studies of associated higher fluid chloride content with acute kidney injury and mortality but no large, randomized trials have been conducted. In preparation for a large, cluster-randomized, multiple-crossover trial comparing 0.9% sodium chloride to physiologically-balanced isotonic crystalloids (Lactated Ringers or Plasmalyte-A) in intensive care unit patients, this pilot study will enroll all patients admitted to the medical intensive care unit at a single tertiary center for a sixth month period. The primary objective will be to test the ability of an electronic order entry tool to ensure administration of assigned study fluid or record contraindications to assigned study fluid. The pilot study will also demonstrate the feasibility of collecting demographic, severity of illness, fluid management, vital sign, laboratory, acute kidney injury and renal replacement therapy, and outcome data in an automated, electronic fashion.


Eligibility Criteria:
Inclusion Criteria:

* Admitted to the adult medical intensive care unit (MICU) at Vanderbilt University Medical Center

Exclusion Criteria:

* Age\<18 years old
Vibrotactile Coordinated Reset for the Treatment of Chronic Stroke

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on motor ability within stroke patients. vCR will be administered with a device called the Vibrotactile (VT) Brain Glove. vCR is expected to provide patients with a non-invasive therapy to aid in recovery from a stroke. This study will include a dedicated sham arm that will aid in understanding true treatment effects from vCR.


Eligibility Criteria:
Inclusion Criteria:

1. Age at the time of enrollment: 18-80 years
2. Diagnosis of ischemic or hemorrhagic stroke
3. Disease period of more than 6 months
4. Mini Mental State Examination of at least 24 points
5. No medications that affect balance
6. Motor deficit
7. Use of Motricity Arm and Leg index to include impaired individuals with some functioning
8. Modified Rankin Scale for Neurologic Disability: Scores 3 or 4

Exclusion Criteria:

1. Any significant psychiatric problems, including acute confusional state (delirium), ongoing psychosis, or clinically significant depression
2. Any current drug or alcohol abuse
3. History of recurrent or unprovoked seizures
4. Any neurological disorder treatments that involve intracranial surgery or device implantation
5. Participation in another drug, device or biologic trial concurrently or within the preceding days
6. Pregnancy, breastfeeding or wanting to become pregnant during the trial
7. History or presence of other major neurological or orthopedic diseases other than stroke that limits motor functioning or cognitive ability
8. More than 5 degrees of contracture at shoulder, elbow, wrist, finger, hip, knee, or ankle
9. Botox, baclofen or any other treatment for spasticity except for bracing or splinting within the previous 3 months
10. Must be able to communicate with staff
11. Severe sensory abnormalities of the fingers such as vibratory urticaria
Leg Length Discrepancy and Adolescent Idiopathic Scoliosis: Clinical and Radiological Characteristics

The aim of this retrospective study is to present clinical and radiological features and their relationships for differentiating functional scoliosis due to LLD and LLD concurrent with AIS.

This study was conducted as a single-center retrospective comparative study on 47 consecutive scoliosis patients detected LLD, aged 10-18 years, between 2018 and 2020. The scoliosis patients with a diagnosis of structural LLD were divided into two groups according to whether there was a concurrent AIS diagnosis or not. Demographic data were recorded. Limb length was clinically measured by direct, indirect evaluation method and new LLD-Scoliometer Test. Cobb degree, axial rotation, internal/external pelvic obliquity and LLD were obtained from posteroanterior spine radiographs measured by two blinded orthopaedic spine surgeons.

Eligibility Criteria:
Inclusion Criteria:

* Between December 2018-2020
* Scoliotic patients, who detected LLD
* Ages 10 to 18 years
* Patients who have two or more clinical records at least 6 months apart
* Who accepted to participate in the study.

Exclusion Criteria:

* Neurological disease
* A history of spinal surgery/tumors
* The diagnosis of AIS without LLD or trauma
To Establish the Traditional Chinese Medicine Based Intelligent Personal Health Care System

Development of a New Generation Chinese Medicine Constitution Assessment Scale

Development of a New Generation Chinese Medicine Constitution Assessment Scale:

A. Analyzing the existing CCMQ and BCQ questionnaire syntax. B. Redesigning the scale's question statements. C. Reintegrating the scale items and constitutional characteristics. D. Testing and evaluating the reliability and validity of the questionnaire, cross-assessing with diagnoses from experienced Chinese medicine practitioners.

E. Collecting feedback and reviewing modifications based on the responses from the general population questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Aged over 18 and under 85.
* Participants agreed to join the trial by fully understanding the purpose of the study and the entire trial process and then signed an informed consent.
* Able to fill out online questionnaire with any electronic device in person or under assistance

Exclusion Criteria:

* Age of subjects was under 18 or more than 85 years old.
* Participants who do not meet the above criteria
* Subjects were not willing sign the informed consent.
VR Exercise Intervention in a Workplace Setting

This research study is designed to better understand how a virtual reality (VR) exercise application may influence overall physical activity and well-being. VR games can make exercise more enjoyable and interactive, which has been shown to increase engagement in physical activity. Adult participants will do a progressive exercise program and report on overall physical activity, health, and psychological wellbeing. The intervention is expected to have a positive impact on these lifestyle factors.

irtual Reality (VR) fitness applications are promising interventions to promote exercise in a home setting. Multiplayer fitness games for virtual reality platforms, addresses several common challenges associated with decreased exercise adherence such as social accountability, transportation, weather, gym memberships, and self-consciousness. This study aims to assess the impact of regular usage of a commercially available virtual reality fitness application on quality of life measures, including physical activity, health, and well-being. This study will enroll healthy participants, age 18- 50 years old, and they will be issued a Quest 2 virtual reality headset and given access to the virtual reality fitness application (VRWorkout - VRW). Participants will be asked to use VRW on a regular and progressive basis over a six-week period and to complete surveys about physical activity and wellbeing over a 9-week period. The activity completed within VRW is based on participant choice. A suggested progression schedule will be provided, but not enforced. This study of healthy working individuals, is foundational to assessing whether immersive fitness applications may be used as a lifestyle intervention to increase overall physical activity and well-being.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* Individuals who have been advised by a healthcare provider that they should not participate in moderate to strenuous physical activity for any reason
* Individuals with history of seizures with photosensitivity
* Individuals with diagnosis of uncontrolled metabolic disorders
* Current lice infestation
* Current eye infection
* Body Mass Index above 30 (obese)
Helicobacter Pylori Eradication With Clostridum Butyricum Capsule and Bacillus Coagulans Tablets

This study aims at evaluating efficacy Clostridum Butyricum Capsule and Bacillus Coagulans Tablets in H. pylori eradication. It is hypothesized that Clostridum Butyricum Capsule , Bacillus Coagulans Tablets monotherapy or Clostridum Butyricum Capsule plus Bacillus Coagulans may have some positive effect on H. pylori eradication.

The study will include three phases: screening, treatment and follow-up. Screening: during this phase subjects eligibility will be evaluated after informed consent signature. Endoscopy and Urea Breath test will be performed in addition to the baseline routine evaluations.

Treatment: Subjects are randomly assigned to treatment and will be treated for 8weeks.

Follow-up: includes one visits. Eradication of H. Pylori will be confirmed through urea breath test(UBT).

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18\~70,both gender.
2. Patients with upper gastrointestinal symptoms and with documented H.pylori infection.
3. Patients are willing to receive eradication treatment.
4. Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter.

Exclusion Criteria:

1. Patients are excluded if they have previously used antibiotics to eradicate adequately recorded infection with H. pylori.
2. Contraindications to study drugs.
3. Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease.
4. Constant use of anti-ulcer drugs ( including taking proton-pump. inhibitors(PPI) within 2 weeks before the \[13C\] urea breath test), antibiotics or bismuth complexes (more than 3 times /1 month before screening).
5. Pregnant or lactating women.
6. Patients were diagnosed with gastroduodenal ulcer and MALT lymphoma.
7. Underwent upper gastrointestinal Surgery.
8. Patients with Barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia.
9. Evidence of bleeding or iron efficiency anemia.
10. A history of malignancy.
11. Drug or alcohol abuse history in the past 1 year.
12. Systemic use of corticosteroids, non steroidal anti-inflammatory drugs, anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
13. Enrolled in other clinical trials in the past 3 months.
14. Patients who has psychological problem or poor compliance.
15. Refuse to sign informed consent.
Atrial Pacing for Termination and Prevention of Atrial Fibrillation

Atrial fibrillation (AF) is the most common sustained arrhythmia and is associated with substantial morbidity and mortality. Present treatment strategies are aimed at termination of AF and prevention of AF recurrence using antiarrhythmic drugs or heart rate control drugs. Drugs are not always well tolerated, so atrial pacing as a strategy for prevention of atrial tachyarrhythmias is being explored.

The AT501 pacemaker has both "prevention" and "treatment" algorithms for atrial tachyarrhythmias. The investigators wish to determine whether these special features, over the long term, decrease the amount of time the person experiences AF.

There are some clinical and experimental data to suggest that atrial overdrive pacing should prevent AF. In our pacemaker population with tachy-brady syndrome, and in the PA3 study population, we observed that AF frequently clusters and may recur early following an episode of AF.

We are conducting a randomized trial of both prevention algorithms and antitachycardia pacing (ATP) therapies for the treatment of atrial tachyarrhythmias and thereby prevention of AF over the longterm.

Patients with a history of paroxysmal AF who received an AT501 pacemaker for the treatment of bradycardia will be randomized to having both the prevention and therapy algorithms "ON", both "OFF" or having only the therapy algorithms "ON". They will be followed every 3 months for 1 year, then every 6 months for an 2 additional years. Recurrence and frequency of AF will be determined over time based on data retrieved from the device at each follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Reason for pacing: symptomatic bradycardia
* Paroxysmal AF (\>5 min duration, \>3 episodes) post implant of AT501 pacemaker
* On stable antiarrhythmic drugs
* Life expectancy \>3 years

Exclusion Criteria:

* Life expectancy \<3 years
* Unable to give informed consent
* Unable to come for followup
* Chronic AF
Implemental Flutter Mucus Clearance Devices on Geriatric Lung Function

The purpose of this study is to evaluate the clinical outcome and safety of flutter mucus clearance devices in elders of gerocomium.

Respiratory diseases are still increasing in the elderly population. The fluttering mucus clearance technique is expected to be a physical assisting therapy enhancing airway secretion clearance but needs more clinical randomized, controlled trial evidence.

Eligibility Criteria:
Inclusion Criteria:

* available to perform the device, the elders in geracomium
* male and female
* aging 85 years or more

Exclusion Criteria:

* not available to perform the procedure
* untreated pneumothorax
* diffusion interstitial lung disease
* acute coronary syndrome
* third stage hypertension
* advanced cancer
* severe heart, liver, renal, blood system and endocrine system dysfunction
* noninvasive mechanical ventilation
* active hemoptysis