cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy Study of Etanercept (Enbrel®) In Children With Systemic Onset Juvenile Rheumatoid Arthritis

The primary objective of this study was to determine the efficacy of etanercept in pediatric patients with systemically active system onset juvenile rheumatoid arthritis (SOJRA).

Participants were to receive etanercept at a dose of 0.4 mg/kg twice weekly in Part 1A. Participants who had a partial response (not able to reduce prednisone dose by 50% of the baseline dose in 5 months) while on 0.4 mg/kg twice weekly etanercept in Part 1A were to enter Part 1B for up to 4 months and were to have the dose of etanercept increased to 0.8 mg/kg twice weekly. Participants who did not meet the response criteria in Part 1A or Part 1B of the study were to be withdrawn from the study as non-responders. Participants who responded in either Part 1A or Part 1B were randomized into Part 2, where they received etanercept or matching placebo in a double-blind manner twice weekly for up to 3 months. In Part 2, participants were stratified by the dosage of etanercept (0.4 mg/kg or 0.8 mg/kg) they were receiving in Part 1A or Part 1B. Participants could enter Part 3, the open-label re-treatment portion of the study, only if they had been entered into Part 2 of the study and had either flared in Part 2 or had completed 3 months of treatment in Part 2. The maximum time participants could receive etanercept in Part 2 and Part 3 combined was 12 months.

Eligibility Criteria:
INCLUSION CRITERIA:

* 2 - 18 years of age
* SOJRA for at least 3 months, with stable systemic features
* If taking methotrexate, hydroxychloroquine, or NSAIDs, dose must be stable
* Must take prednisone at a stable dose

EXCLUSION CRITERIA:

* Need for other DMARDs or prestudy requirements for oral or parenteral pulse steroids or intra-articular steroids
* Pregnant or nursing female
* Clinically significant abnormal laboratory test results for blood cells, liver or kidney function, or serology
* Previous receipt of any tumor necrosis factor (TNF) inhibitor
* Live virus vaccine within 12 weeks of study entry
* Participation in another study requiring informed consent within 12 weeks of entry
* Diabetes that requires insulin treatment
* Infection, chronic, recurrent, or currently active
* Any serious medical or psychiatric condition or history of alcohol or drug abuse
Relationship Between Dosage of Clopidogrel and Platelet Aggregation in Chinese With Different Genotype

This study is a prospective, observational study to estimate the relationship between dosage of clopidogrel and platelet aggregation in Chinese with different genotype. The investigators suppose both pretreatment dosage of clopidogrel before percutaneous coronary intervention (PCI) and CYP2C19 genotype may effect the platelet aggregation as well as clinical outcome.


Eligibility Criteria:
Inclusion Criteria:

* accept PCI in Chinese CHD patients
* expected dual antiplatelet therapy (DAPT) at least 6 months

Exclusion Criteria:

* another planned PCI within 6 months
Effect of Holly Mangrove Shower Gel in Atopic Dermatitis Patients

Atopic dermatitis is a chronic intermittent inflammatory skin disease. Currently, there are many cosmeceutical skin products in which their major action affects skin hydration and skin barrier function. In addition, there are some herbal medication remedies used for the treatment of skin diseases based on the knowledge of Thai traditional medicine. Patients with pruritic rash symptoms who attended the Center of Applied Thai Traditional Medicine, Siriraj Hospital, were prescribed the Holly Mangrove Shower Gel to use and on the follow-up appointment showed significant improvement. Nevertheless, the knowledge of using this herbal medication for treating pruritic skin rash so far has been categorized as folk wisdom and not been confirmed by any clinical-trial study on its efficacy and mechanism of action.

Research teams chose Holly Mangrove Shower Gel containing Acanthus ebracteatus Vahl to act as adjunctive for treating atopic dermatitis. Thus, for the purpose of studying the efficacy of Holly Mangrove Shower Gel containing Acanthus ebracteatus Vahl in improving the skin barrier function in atopic dermatitis.

The investigators team research with patients by separate patients into 2 groups and compare among each other. In the first group use placebo, the other group use Holly Mangrove Shower Gel. To compare outcomes, the investigators will measure transepidermal water loss, stratum corneum hydration, skin pH, sebum and wrinkles after using studied gel.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years old or above
* Diagnosed as atopic dermatitis (Hanafin and Rajka criteria)
* No active dermatitis within 2 weeks

Exclusion Criteria:

* Pregnancy or lactation
* Any other skin diseases on forearms
Sedative-Anxiolytic Effects on Simulated Driving Performance

This study evaluates the effect of anxiety drugs taken at night on the ability to drive a car the next day. Participants will receive alprazolam, placebo, or zolpidem at night before bed or in the morning before using a driving simulator to assess impairment.


Eligibility Criteria:
Inclusion Criteria:

* valid driver's license
* english-speaking and literate

Exclusion Criteria:

* using daily medication for chronic condition
* acute narrow angle glaucoma
* previous adverse experience with study drugs
* experiences motion sickness in response to driving simulator
* BMI \> 30
* women who are pregnant, lactating, or planning on becoming pregnant
* regular use of tobacco products
* current substance use disorder
* clinically significant ECG
* current ongoing psychiatric disorder
N-acetylcysteine (NAC) for Pediatric Obsessive-Compulsive Disorder

Pediatric Obsessive-Compulsive Disorder (OCD) affects 1-3% of children. The investigators currently have effective first-line interventions for pediatric OCD such as Cognitive Behavioral Therapy (CBT) and pharmacotherapy with serotonin reuptake inhibitors (SRIs). However, roughly half of children with OCD still have clinically significant OCD symptoms despite treatment with first-line pharmacological treatments and CBT interventions for OCD. Furthermore, all pharmacological treatments for OCD in children have an increased side effect burden when compared to adults. Novel treatments for children with OCD are needed.

N-acetylcysteine (NAC) is a natural supplement that acts as an antioxidant and a glutamate modulating agent. NAC has been used safely for decades in doses 20-40 times higher than in this trial as an antidote for acetaminophen overdose. The only side-effect commonly seen with NAC is nausea and this side-effect is seldom seen in the doses used in this trial.

NAC has recently been demonstrated to be effective in a double-blind, placebo-controlled trial in adults with trichotillomania (chronic hair pulling). Trichotillomania is an obsessive-compulsive spectrum disorder that is hypothesized to be closely related to OCD. In other trials NAC has evidence of some efficacy in treating diverse psychiatric conditions such as bipolar depression, schizophrenia and cocaine dependence.

The investigators are conducting this trial to determine if NAC is effective in treating OCD.


Eligibility Criteria:
Inclusion Criteria:

* Children aged 8-17 years.
* Primary diagnosis of OCD.
* Duration of OCD greater than 6 months.
* Significant Current OCD symptoms: Current CY-BOCS score \> or = 16.

Exclusion Criteria:

* Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or mental retardation (IQ\<70).
* Recent change (less than 4 weeks) in medications that have potential effects on OCD severity (such as Selective Serotonin Reuptake Inhibitors, clomipramine, naltrexone, lithium, psychostimulants, anxiolytics, or antipsychotics). Medication change is defined to include either dose changes or medication discontinuation.
* Recent change in behavioral treatment for OCD or comorbid conditions within the last 4 weeks or initiation of behavioral therapy for tics within the last 12 weeks.
* Asthma requiring medication use within the last 3 months (case reports have linked intravenous NAC administration with asthma exacerbation)
* Known hypersensitivity or previous anaphylactoid reaction to acetylcysteine or any components in its preparation.
* Positive pregnancy test or drug screening test.
* Previous use of N-acetylcysteine (dose greater than 600mg for more than 2 weeks).
* Previous history or suspicion of cystinuria because of a possibility of forming kidney stones.
Protecting the Corneal Endothelium During Cataract Surgery Using the Anterior Capsule

Cataract surgery is one of the most frequently performed surgical procedures worldwide. Since the introduction of phacoemulsification to remove the cataractous lens, risk and complication rates of cataract surgery decreased significantly.

The phacoemulsification technique utilizes a high-intensity ultrasound energy for the fragmentation and emulsification of the lens. One of the main complications during phacoemulsification, is damaging of the endothelium due to contact with lens fragments of the nucleus following turbulent flow of irrigating solution, resulting in corneal damage, inflammation of the endothelium and corneal edema.

In this study we want to evaluate the effect of the anterior capsule, gained by capsular rhexis, as a corneal shield during phacoemulsification on the corneal endothelium.


Eligibility Criteria:
Inclusion Criteria:

* Cataract
* Age 21 and older
* Written informed consent prior to surgery
* Moderate to severe nuclear or mixed cataract

Exclusion Criteria:

* Corneal pathologies
* Pregnancy
* Patients with an increased surgical risk (i.e. patients with pseudoexfoliation syndrome, patients with the potential risk of intra-operative floppy iris syndrome)
Individual Differences in Diabetes Risk: Role of Sleep Disturbances

The hypothesis for this study is that some individuals may be at much higher risk to develop type 2 diabetes and that the individual diabetes risk will be predicted by the individual level of slow wave sleep activity (SWA).


Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women with low Slow Wave Sleep Activity (SWA) or high SWA with the gender distribution in each group matching the gender distribution of active duty Army personnel (85% men; 15% women) based on the following inclusion criteria:

  * age 18 to 29 years,
  * normal weight or modestly overweight (BMI ≤ 27 kg/m2 for women, BMI ≤ 28 kg/m2 for men),
  * normal findings on clinical examination, normal routine laboratory tests results, normal EKG, no history of psychiatric, endocrine, cardiac or sleep disorders.
* Only subjects who have regular life styles (no shift work, no travel across time zone during the past 4 weeks), habitual bedtimes between 7.0-8.5 hours, and do not take medications will be recruited.
* An overnight polysomnography will be performed to rule out sleep-disordered breathing (apnea-hypopnea index \> 5/hour) and periodic limb movement disorder (PLM arousal index \>1/hour).
* Women taking hormonal contraceptive therapy and pregnant women will be excluded. In women, all studies will be initiated in the early follicular phase.

Exclusion Criteria:

* Tobacco use.
* Habitual alcohol use of more than 2 1 drink per day.
* Excessive caffeine intake of more than 300 mg per day and individuals with a metal implant or another metal object in their body.

We estimate that we will need to recruit at least 60-70 individuals to obtain two gender-matched groups of 16 individuals with either low or high SWA.
Study of the Effectiveness and Safety of SHR-1314 for Psoriatic Arthritis

This study is a randomized, double-blind, multicenter, placebo-controlled Phase II clinical study, consisting of a 4-week screening period, a 12-week core treatment period, a 12-week maintenance treatment period, and an 8-week safety follow-up period. It is planned to include 111 adult subjects with psoriatic arthritis.


Eligibility Criteria:
Inclusion Criteria:

1. The subject voluntarily signs an informed consent form before any procedures related to the research start;
2. Age ≥18 years old and ≤75 years old at the time of signing the informed consent form, regardless of gender;
3. At the time of screening, it met the 2006 psoriatic arthritis classification standard (CASPAR);
4. There is active PsA before randomization;
5. Have active plaque psoriasis (at least one plaque skin lesion) at the time of screening, or have a history of plaque psoriasis;

Exclusion Criteria:

1. Existence of any of the following medical history or comorbid diseases: drug-induced psoriasis; other active inflammatory diseases or autoimmune diseases; history of organ transplantation; history of lymphocytic proliferation; severe infections, etc.
2. Have received psoriatic arthritis or psoriasis drugs, such as intra-articular injections, plant preparations, etc. within a certain period of time in the past.
3. Those who are allergic to the drug ingredients or excipients in this study, or are allergic to other biological agents.
4. A history of alcohol abuse or illegal drug abuse in pregnant or breastfeeding women, etc.
Oncological and Functional Outcomes After Radical Prostatectomy for Prostate Cancer: Comparing Open With Robot-assisted Surgery

For primary surgical treatment of prostate cancer the investigators compare the classic open surgery (radical retropubic prostatectomy, RRP) versus robot-assisted laparoscopic surgery (RALP). Oncological results are obtained at standard follow-up consultations through Prostate-Specific Antigen (PSA) measurement to detect biochemical recurrence. Functional results (continence, potency, quality of life) are obtained through standardised questionnaires. Currently the investigators perform all of their prostatectomies in a robot-assisted manner. For results of the open surgery the investigators send questionnaires to patients who had the operation in the past.


Eligibility Criteria:
Inclusion Criteria:

* prostate cancer
* radical retropubic prostatectomy or
* robot-assisted laparoscopic surgery

Exclusion Criteria:

-
Potential Molecular Predictors of Response to Novel Therapies in Metastatic Pancreatic Neuroendocrine Tumors

Sunitinib and everolimus are two new treatments approved in 2011 for patients with pancreatic neuroendocrine tumors (NETs). In addition, some traditional chemotherapies are often used to treat pancreatic NETs. Traditional chemotherapy is also known as "cytotoxic therapy" and works by killing cells that are actively dividing. There have been no studies to compare the different types of treatment. Since the patient is eligible for treatment with either sunitinib, everolimus or traditional chemotherapy it can help us identify factors that may help future patients benefit from these therapies.


Eligibility Criteria:
Inclusion Criteria:

* Histopathologic evidence of well differentiated pancreatic NET
* Evidence of measurable disease by RECIST 1.1. Both patients with synchronous disease and those with prior resected primary cancers will be eligible.
* Patient ≥18 years of age on the day of signing informed consent.
* Planned initiation of active therapy with everolimus ,sunitinib or traditional cytotoxic chemotherapy.

Patients can be included in this study, regardless of prior therapy, but cannot undergo concurrent therapy, such as hepatic artery embolization

* Available archival tissue with adequate FFPE tissue for analysis verified by a pathologist (in cases of biopsies less than 2 cm and/or less than 70% tumor content 10 slides will be required for adequate DNA preparation. For larger biopsies and any resections, 5 slides are sufficient for DNA extraction).

Exclusion Criteria:

* Patient has a history of a second active malignancy with evidence of metastases. Patients with a history of resected prior malignancy are allowed.
* Patient has known psychiatric or substance abuse disorders that would, in the opinion of the treating investigator, interfere with cooperation with the requirements of the trial.
Objective Systolic Function Recuperation Assessed by Echocardiography

The purpose of this study is to evaluate left ventricular systolic ejection fraction and anterior or apical akinesis 1 month and 3 months after a myocardial infarction treated with primary PCI to determine whether improvement at 1 month differs from improvement at 3 months.


Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years old
* ST elevation myocardial infarction treated with primary PCI
* Anterior or apical akinesis and left ventricular ejection fraction ≤ 45% on early echocardiography (48hours - 7 days post myocardial infarction)
* Initial ECG showing at least 1 mm ST elevation in 2 leads corresponding to the same vascular territory

Exclusion Criteria:

* Known left ventricular systolic dysfunction before myocardial infarction
* Left bundle branch block
* Vital prognosis less than 6 months
* Cardiogenic shock
* Rescue PCI
* Sub-optimal echocardiographic imaging (contrast use is allowed)
* Significant valvular heart disease (moderate or severe)
* Surgical revascularization
* Pregnancy or breastfeeding
* Incapacity to provide informed consent
An Efficacy and Safety Study of MORAb-003 in Platinum-Resistant or Refractory Relapsed Ovarian Cancer

The study is being conducted to find out if paclitaxel works better when given together with an experimental drug called MORAb-003 (farletuzumab) or alone in patients with platinum-resistant or refractory relapsed ovarian cancer

Safety was assessed by the monitoring and recording of all adverse events (AEs), including drug hypersensitivity adverse events (DHAE), and serious adverse events (SAEs); clinical laboratory test (serum chemistry, hematology, urinalysis); tolerability (discontinuations, treatment delays, dose reductions); physical examinations (including vital signs assessment); 12-lead electrocardiograms (ECG) obtained in triplicate and reviewed by independent blinded cardiologist, and Karnofsky's performance status.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of non-mucinous epithelial ovarian cancer, including primary peritoneal and fallopian tube malignancies, measurable by CT or MRI scan assessed within 4 weeks prior to study entry
* Must have evidence of relapse by CA-125 (2xUpper Limit of Normal) or radiographically within 6 months of most recent platinum-containing chemotherapy. At least one of the lines of chemotherapy must have included a taxane.
* Must have been treated with debulking surgery and at least one line platinum-based chemotherapy;
* Subjects may have received up to four additional lines of chemotherapy after they developed platinum-resistance.
* Subjects must be candidate for repeat paclitaxel treatment

Exclusion Criteria:

* Clinical contraindications to use of paclitaxel, which include:

  1. persistent Grade 2 or greater peripheral neuropathy
  2. prior hypersensitivity reaction that persisted despite rechallenge with or without desensitization or resulted in bronchospasm or hemodynamic instability or was at least Grade 2 and resulted in medication discontinuation
* Current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas). Note: EOC with prior diagnosis of a low malignant potential tumor that has been surgically resected is acceptable provided the subject did
* Prior radiation therapy is excluded with the exception that it is allowable only if measurable disease for ovarian cancer is completely outside the radiation portal
* Known allergic reaction to a prior monoclonal antibody therapy or have any documented human anti-human antibody (HAHA).
* Previous treatment with MORAb-003 (farletuzumab).
Memory Changes in Patients With Major Depression Disorder Treated With ECT

The basic memory changes (impairment) present in patients with major depression and the influence of the treatment with ECT.

Current literature provides insufficient information on the degree of cognitive impairment during and after electroconvulsive therapy (ECT), mostly due to the fact that applied tests lacked sensitivity and flexibility. Our goal was to evaluate cognitive functioning in adult depressed patients treated with bi \& uni lateral \& ECT, using tests sensitive for detection of possible acute and medium-term memory changes.(9) Major depressive disorder (MDD) is estimated to affect around 16 million Americans (Substance Abuse and Mental Health Services Administration \[SAMHSA\], 2013) and, according to the World Health Organization, is the leading cause of disability worldwide (World Health Organization 2012). Among In the U.S. workforce, the prevalence of MDD has been estimated at 7.6% .(2) Electroconvulsive therapy (ECT) is an effective treatment for severe depression but entails cognitive adverse effects, particularly the effects on memory. ECT may cause a temporary deficit in the cognitive processes of information encoding, consolidation, and retrieval. Transient memory disturbances are regarded as an inevitable adverse effect of therapeutic convulsions. Various strategies have been tried to decrease the cognitive adverse effects while retaining the antidepressant effect, including the use of unilateral instead of bilateral electrode placement, changes in waveform, and reducing the electrical stimulus intensity, (4).

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed as having major depression according to DSM V.
2. Patients aged (18-50 years) of both sexes.

Exclusion Criteria:

1. History or current evidence of systemic medical illness, e.g.: hepatic, renal, cardiovascular, endocrinal, metabolic disorders or others.
2. History or current evidence of any Neurological disease.
3. Pregnant females.
4. Co-morbid psychiatric disorders other than depression.
5. Patients with mental subnormality.
In Utero Exposure to SARS-CoV-2 (COVID-19) and Cardiovascular and Metabolic Endpoints in Early Life

Since its initial outbreak in late 2019, coronavirus disease 2019 (COVID-19) caused by the novel coronavirus SARS-CoV-2 has ravaged the globe, causing illness characterized by inflammation and impaired oxygen levels. As a particularly vulnerable group, pregnant women have had a heightened prevalence and severity of infection. In this context, a new population of children has emerged who were exposed to maternal COVID-19 in the womb. As maternal diseases during pregnancy may impact the health of offspring over the life course, health outcomes among these individuals must be urgently evaluated. In the current study, the investigators will leverage a perinatal biorepository comprised of pregnant women with and without COVID-19 to delineate the metabolic and cardiovascular risk profiles of these offspring. This work stands to benefit the burgeoning population of children exposed to COVID-19 in the womb and to deepen the mechanistic understanding of developmental origins of cardiometabolic disease with respect to maternal infections.


Eligibility Criteria:
Inclusion Criteria:

* Mother with or without prenatal COVID-19 who was enrolled in the MGH COVID-19 Perinatal Biorepository and her child (9-24 months old)

Exclusion Criteria:

* Child with any history of documented COVID-19
* Mother who received the COVID-19 vaccine during pregnancy with her child
* Significant chronic illness in mother or child judged by the investigator to represent a contraindication to study participation