cyrilzakka/clinical-trials huggingface dataset:
Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

The objective of this retrospective observational study is to compare commonly prescribed bipolar disorder medications for their impact on: (1) hospitalization; (2) suicide attempts and self-harm; and (3) risk of drug-induced adverse effects such as kidney disease and diabetes mellitus. In addition, the investigators will examine heterogeneity of treatment effect by co-morbidity within pediatric, adult, and elderly sub-populations. Patient focus groups are convened to elicit additional questions and provide feedback on results.

Funded by PCORI, the objective of this retrospective observational study is to perform several safety and effectiveness comparisons on commonly prescribed bipolar disorder medications, engaging patient focus groups in generating additional questions and interpreting results.

The study will be a retrospective cohort study conducted with administrative claims data from the Truven MarketScan Commerical Claims and Encounters and Medicare database from 2010-2016.

The database contains approximately 140 million patients within the US population in every state and nearly every county in the nation, across all ages, ethnicities and socioeconomic categories, including privately insured, and Medicare patients. The study will focus on approximately one million patients with two or more diagnoses of bipolar disorder in the claims records according to ICD-9 and/or ICD-10 coding.

The treatments that will be compared are lithium carbonate; first generation antipsychotics: haloperidol and perphenazine; second generation antipsychotics: clozapine, risperidone, olanzapine, aripiprazole, quetiapine, ziprasidone, asenapine, lurasidone, and paliperidone; mood stabilizing anticonvulsants: valproate, lamotrigine, carbamazepine, and oxcarbazepine; antidepressants: mirtazapine, bupropion, desvenlafaxine, duloxetine, venlafaxine, citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, vilazodone, and doxepin.

The investigators will perform cross-sectional and survival based analysis using regression, propensity scoring, and local control to perform bias-corrected comparisons of the above treatments for for their impact on: (1) hospitalization; (2) suicide attempts and self-harm; and (3) risk of drug-induced adverse effects such as kidney disease and diabetes mellitus. In addition, the investigators will examine heterogeneity of treatment effect by co-morbidity within pediatric, adult, and elderly sub-populations.

Eligibility Criteria:
Inclusion Criteria:

* Two or more instances of bipolar disorder diagnoses within administrative claims records

Exclusion Criteria:

* Patients with less than 1 year of history in the database
Study To Understand Efficacy And Safety Of Investigational Agent (PF-04937319) Compared To Approved Agent (Glimepiride) In Patients With Diabetes On Metformin

This is a study to understand efficacy and safety of investigational agent (PF-04937319) compared to approved agent (glimepiride) in patients with diabetes on metformin


Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 yrs, male and females, with T2DM, on metformin alone or in combination with 1 other oral agent

Exclusion Criteria:

* Subjects with recent cardiovascular events, those with evidence of diabetic complications
COPE With COPD Trial

The overall objective of this study is to evaluate a collaborative self-management intervention in patients with moderate to severe COPD in a primary care population. To achieve this objective the investigators developed a diagnostic and treatment pathway for the management of COPD in primary care that is based on national guidelines and focused on patient self-management.

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Eligibility Criteria:
Inclusion Criteria:

* Current or Ex-smokers
* 40 years of age or over
* Minimum 10 pack year smoking history
* Post-bronchodilator FEV1 of 70% or less (4 puffs of Salbutamol) and Forced Expiratory Volume at 1sec to Forced Vital Capacity (FEV1/FVC) ratio 70% or less
* A history of two exacerbations (involving treatment and/or visit to a health care practitioner) in the past 3 years OR 1 exacerbation in the past year
* Provides informed consent

Exclusion Criteria:

* COPD exacerbation in the past 4 weeks
* Diagnosis of asthma prior to the age of 40 years
* Co-existing illness that could interfere with study results (ie. Congestive Heart Failure with exacerbation of symptoms)
* Scheduled for COPD rehabilitation
* A terminal illness
Early Versus Expectant Treatment of Ureaplasma Infection in Very Low Birth Weight Neonates

Our hypothesis is that treatment of known Ureaplasma spp. infection of the airways in very low birth weight (VLBW) infants with azithromycin will eradicate the organisms and lessen the proinflammatory state caused by infection that puts them at risk for Bronchopulmonary Dysplasia (BPD). We propose to conduct a randomized trial of early (less than 3 days of age) treatment with intravenous azithromycin versus expectant management for VLBW infants with Ureaplasma spp. respiratory tract infection with the following specific aims: (1) Determine microbiological efficacy, pharmacokinetics, and safety of azithromycin treatment for eradication of Ureaplasma spp. in preterm infants, (2) Determine the respiratory outcomes of infants in the two treatment groups and those without respiratory tract Ureaplasma spp. infection


Eligibility Criteria:
Inclusion Criteria:

* Infants weighing \<1250 grams at birth with respiratory distress syndrome who have respiratory infection with Ureaplasma sp organisms.

Exclusion Criteria:

* Severe respiratory distress syndrome with survival unlikely \>7 days, Congenital malformations
Postoperative Analgesic Efficacy of Tetracaine Hydrochloride Gel

This study was taken out to assess the postoperative analgesic efficacy of tetracaine hydrochloride gel in patients with intrauterine adhesion treating with intrauterine balloon.Participates were assigned into two groups by randomly-tetracaine hydrochloride gel group and control group.

Tetracaine hydrochloride gel contains 1% tetracaine hydrochloride, and a fair dose of fungicide, lubricants, remove foam agent, as the long-term local anesthetics. Patients in getracaine hydrochloride gel group were covered with a gauze of tetracaine hydrochloride gel on the external cervical orifice after insert an utrauterine balloon in the uterine cavity. While patients in the control group were covered with a blank gauze after hysteroscopic adhesiolysis. Compare the postoperative analgesic scor and patients' analgesic satisfaction of the two groups and asess the analgesic efficacy of tetracaine hydrochloride gel.

Eligibility Criteria:
Inclusion Criteria:

* no previous history of hysteroscopic adhesiolysis or surgery on the cervix
* inserted intrauterine balloon in the uterine cavity after hysteroscopic adhesiolysis
* no other diseases

Exclusion Criteria:

* Allergy to local anesthetics
* Patients with chronic pain
* Patients with abnormal blood coagulation function
* Patients with mental illness that can not cooperate
* Patients with previous hysteroscopic adhesiolysis or cervical surgery
Ibuprofen in Migraine Patients

In this study, the investigators planned to compare the effectiveness of an intravenous ibuprofen against an intravenous dexketoprofen among patients (18-65 years) who were admitted to the emergency department (ED) with acute migraine-related headaches and diagnosed migraine without aura.

In this study, patients who presented with migraine-related headache to emergency departments will be included in this study. Two different therapy option are created; first, 400mg intravenous ibuprofen with 10mg intravenous metoclopramide Hcl , second, 50 mg intravenous dexketoprofen with 10mg intravenous metoclopramide Hcl.

Patients's headache scores will be measured with visual analog score (VAS) at the pretreatment and post-treatment periods (0. minutes, 30. minutes, and 60. minutes.) 60 minutes after treatment, as a rescue therapy, 100mg tramadol will be given to patients whose headache score does not decrease by more than 50% from pretreatment-VAS score.


Eligibility Criteria:
Inclusion Criteria:

* All the patients aged 18-65 years who had been admitted to the ED for headaches and diagnosed acute migraine-related headache according to the International Classification of Headache Disorders-2018 edition
* Patients whose pre-treatment VAS scores are more than 40 point.
* Patients who give written and verbal consent to include study.

Exclusion Criteria:

* Patients had taken any analgesic drugs or drugs for migraine prophylaxis in the last 6 hours
* Patients had a history of allergy to any of the drugs used in this study
* Patients used any anticoagulant-agents,
* Patients had bleeding diathesis
* patients were pregnant,
* patients were breastfeeding mothers
* Patients who had chronic heart disease, chronic liver disease, and chronic kidney disease
* Patients had peptic ulcer
* Patients had a history of acute akathisia or acute dystonia to metoclopramide hcl
Fludarabine, Cyclophosphamide, and Alemtuzumab in Patients With B-cell Chronic Lymphatic Leukemia (B-CLL)

This study aims to assess the short term efficacy of a combination immunochemotherapy in patients with relapsed B-cell chronic lymphatic leukemia.


Eligibility Criteria:
Inclusion Criteria:

* B-CLL in need of treatment
* One or two prior prior therapies
* WHO performance status 0-2

Exclusion Criteria:

* Serum creatinine \> 1.5 ULN
* Major organ dysfunctions
* Pregnant or nursing
Fish Oil vs. Placebo on Subjective Effects of Alcohol

This project represents a first step in examining the potential use of fish oil for the treatment of alcohol use disorder (AUD). The investigators will be testing for attenuation of alcohol-induced sedative and stimulant effects, as well as cognitive effects and cerebellar effects in healthy social drinkers.

There have been no studies to date that have examined the relationship between fish oil and alcohol response in humans. The current study was designed to examine the relationship between fish oil and subjective alcohol effects in healthy social drinkers.

This project represents a first step in examining the potential use of fish oil for the treatment of alcohol use disorder (AUD). The investigators will evaluate responses to alcohol through administration of a steady state blood alcohol level (BAL) with an IV infusion using a method that employs an infusion that is titrated to a breathalyzer reading and clamped at a steady state. This approach allows direct comparisons of the acute effects of a specific dose of ethanol between groups, without the confounding factors of variable alcohol absorption and peak BAL's. This approach will allow the examiners to carefully examine if fish oil changes the acute effects of alcohol on a number of outcome domains including subjective drug effects, cognitive performance, and cerebellar effects.

As this study is a pilot study, it is not clear whether fish oil will attenuate alcohol induced subjective stimulation or sedation. Since this is the first study to evaluate fish oil's effects on alcohol-effects in the laboratory, the investigators will be testing for attenuation of alcohol-induced sedative and stimulant effects, as well as cognitive effects and cerebellar effects.

In this study, fish oil will be administered at 3 grams/day for 30-40 days (3 capsules twice a day). The investigators will use 3 grams/day for two reasons: 1) it is within the range of doses safely used in humans (1g to 6g) as a treatment for various psychiatric conditions (depression, anxiety, borderline personality disorder), and 2) is a dose that has shown efficacy in various clinical trials for psychiatric conditions.

Eligibility Criteria:
Inclusion Criteria:

1. Male and females, between the ages of 21 and 55;
2. No current drug use disorder of any drugs of abuse (except tobacco or marijuana);
3. No current medical problems and normal ECG;
4. For women, not pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods.

Exclusion Criteria:

1. Current major psychiatric illnesses including mood, psychotic, or anxiety disorders;
2. History of major medical illnesses; including liver diseases, heart disease, chronic pain or other medical conditions that the physician investigator deems contraindicated for the subject to be in the study;
3. Liver function tests (ALT or AST) greater than 3 times normal;
4. Allergy to seafood.
Exogenous Surfactant in Very Preterm Neonates in Prevention of Bronchopulmonary Dysplasia

Advances in perinatal care have made it possible to improve the survival of the most immature neonates, but at the cost of an increase in the population at risk of developing bronchopulmonary dysplasia (BPD). Measures that have attempted to limit the development of BPD are not always effective, or related to major side effects. The physiopathological factors that are identified in BPD should, in theory, respond to surfactant. Therefore, the use of an exogenous surfactant in neonates presenting with pulmonary disease requiring mechanical ventilation, leading to a significant risk of BPD, should allow earlier extubation and thus promote pulmonary healing and growth.


Eligibility Criteria:
Inclusion Criteria:

* any neonate of gestational age less than 33 weeks of amenorrhea still on conventional assisted ventilation or HFOV (High Frequency Oscillatory Ventilation), after 14 ± 2 days of life

Exclusion Criteria:

* active infection (CRP \> 30 mg/L) not controlled by appropriate antibiotic treatment
* use of corticosteroids in the postnatal period
* significant neurological or malformative disease
* surgical intervention \< 72 hours
* refusal of parental approval
Effects of m CIMT and Bilateral Arm Training on Upper Extremity Chronic Stroke Patients

To compare and evaluate the effects of Modified Constraint Induced Movement Therapy (mCIMT) \& Bilateral Arm Training on upper extremity in chronic stroke patients this study will be conducted

Stroke is the abrupt loss of neurological function, due to disturbance of the blood flow in the brain. There is variety of crucial sign and symptoms that can occur during stroke include changes in the level of consciousness and impairments of sensation and motor or cognitive function loss. It also includes changes in perceptual and language functions. Worldwide, 55 million people died of stroke in 2002, and approximately 20 percent of these deaths occurred in South Asia. Predicting amounts of deaths from stroke will increase to 63 million in 2015 and 78 million by 2030 with the mass occurring in the poor countries of the world. Rehabilitation plays a major role in minimizing activity limitation and participation restriction or to decrease extent of impairments. Stroke can cause variety of impairments which have greater impact on the patient quality of life. Hemiparesis is the common impairment, in which involvement of upper limb is commonly seen.

mCIMT and BAT techniques both play an important role in the treatment of stroke. In this research, both techniques will be use to evaluate which treatment technique is better for upper extremity chronic stroke patients. Written informed consent will be taken. Each participant will be requested to draw either number one or number two from a box. Number one will be allocated to Group A and number two will be allocated to group B. The A group will receive mCIMT after applying conservative management and Group B will receive BAT for 5 days a week for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Ability to follow instruction \& 2 steps command(Mini mental state score \> 22)
* At least 6 month after stroke

Exclusion Criteria:

* Spasticity, defined as a score of 3 or more on Modified As worth scale (MAS)
* Uncontrolled hypertension (190/110 mm Hg)
High Plasma Level of Long Pentraxin 3 is Associated With Insulin Resistance in Women With Polycystic Ovary Syndrome (PCOS)

In the present study, serum pentraxin 3 level and its relationship with insulin resistance were determined in patients with Polycystic Ovary Syndrome (PCOS. It was found that PTX3 level is increased in patients with PCOS and it is positively correlated with HOMA-IR.


Eligibility Criteria:
Inclusion Criteria:

* Absence of significant abnormalities on physical examination except hirsutism
* No lipid lowering, hypoglycemic, antihypertensive or hormone replacement therapy
* Normal thyroid function and prolactin level
* Absence of history or evidence of metabolic, cardiovascular, respiratory or hepatic disease

Exclusion Criteria:

* Pregnant
* Possible ovarian tumors,
* Congenital adrenal hyperplasia or
* BMI greater than 35 kg/m2
Early Verticalization in neuroICU With ERIGO: a Safety and Feasibility Study

Severe brain injuries induce alteration of state of consciousness. These functional limitations can be significantly alleviated by treatment neurorehabilitation, particularly if this is established early. It has been shown that treatment of vertical integration in patients in a vegetative state or minimally conscious state can improve the level of supervision and positive influence on rehabilitation. Therefore, there are sufficient indications that anticipate the treatment of vertical integration, since the phase of hospitalization in ICUs, may improve the functional outcome of the patient.

Early verticalization and stepping with the equipment Hocoma Erigo, during monitoring of vital parameters. The device Erigo is already CE marked and, for the purposes of the study, will be used in accordance with the intended use of the same mark (after-market clinical investigation).

Eligibility Criteria:
Inclusion Criteria:

1. Patient / a severe acquired brain injury occurred 3 to 30 days prior to enrollment
2. Age between 18 and 75 years
3. Glasgow Coma Scale ≤ 8 at entrance in ICUs
4. Adequate respiratory exchange with PaO2/FiO2 ≥ 250
5. Absence of sedation increased

Exclusion Criteria:

1. Major chest trauma with multiple rib fractures and / or pneumothorax
2. Presence of fractures, vascular lesions, skin lesions with loss of substance in the abdomen, pelvis or lower limb
3. Cardiovascular instability despite support with amines
4. Intracranial pressure (ICP)\> 25 mm / Hg
5. Cerebral Perfusion Pressure (PPC) \<60 mm / Hg
6. Severe kidney failure requiring replacement therapy
7. Decompensated liver disease
8. Hematocrit value of ≤ 30%
9. Body weight\> 135 kg or height\> 210 cm
10. Deep vein thrombosis
Effect of 1.8-mm Steep-axis Clear Corneal Incision on the Posterior Corneal Astigmatism in Candidates for Toric IOL Implantation

we aimed to analyze the effects of cataract surgery using a 1.8-mm steep-axis clear corneal incision (CCI) on the posterior corneal surfaces based on the keratometry from the rotating Scheimpflug imaging device (Pentacam HR) in candidates for toric intraocular lens (IOL) implantation

Preoperative and at least 1-month postoperative data measured by Pentacam HR were collected in patients for toric IOL implantation. Surgically induced astigmatism on the posterior cornea (P-SIA) was calculated based on the preoperative and postoperative keratometric data, and the related factors of P-SIA were analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. patients aged at least 45 years old who were scheduled for cataract surgery; (2) regular corneal astigmatism ≥ 1.0 D; (3) the imaging quality parameter (QS) of Pentacam HR was "OK"; and (4) follow-up time ≥1.0 month.

Exclusion Criteria:(1) irregular corneal astigmatism; (2) corneal scar, corneal degeneration, pterygium invading the optic zone; (3) corneal endothelium count\<1,000/mm2, corneal endothelial dystrophy, iritis, glaucoma and retinal disease; (4) history of eye surgery, such as corneal refractive surgery, corneal transplantation and retinal surgery; (5) the main incision was expanded or sutures were used during surgery; and (6) some postoperative complications, such as persistent corneal edema, Descemet's membrane detachment and poor wound healing, and any others that might affect the measurement results of the Pentacam HR during the follow-up period.

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Sentinel™ Trial: A Prospective Study Evaluating the Performance and Clinical Benefit of Personalized ctDNA-based MRD Testing to Detect Recurrence and Monitor Treatment Response in Patients With Solid Tumors

The Sentinel™ Trial is a non-randomized, large-scale observational trial designed to: 1) evaluate the ability of circulating tumor DNA (ctDNA)-based minimal residual disease (MRD) testing to detect recurrence in advance of standard-of-care techniques across solid tumors, and 2) determine the clinical benefit of therapy in ctDNA-positive participants.

The study offers the opportunity to 1) serially monitor participants for ctDNA changes, 2) define ctDNA kinetics across tumor and therapy types, 3) identify participants with ctDNA evidence of MRD, and 4) understand the clinical benefit of ctDNA status on treatment outcomes.

Patients with a confirmed diagnosis of a stage I through III solid tumor who have had definitive therapy or curative surgery within the last 5 years or are planning curative surgery may be eligible for the Sentinel Trial. Patients must have a surplus formalin-fixed paraffin-embedded tumor specimen available at screening, or a planned resection within 28 days of screening. To support ctDNA assessment, study procedures will be limited to serial blood draws repeated every 12 weeks until investigator determined recurrence. Upon recurrence, participants will remain on study for 3 years in survival follow-up.

Eligibility Criteria:
Study participants must meet all the inclusion criteria below to enroll:

1. Male or female participants ≥ 18 years of age;
2. Confirmed diagnosis of a stage 1-3 solid tumor;
3. Curative surgery or definitive therapy (e.g., chemoradiation, stereotactic body radiation therapy \[SBRT\]) completed \<5 years ago without any current evidence of radiographical or biochemical recurrence, or planned within 28 days of consent;
4. Surplus formalin fixed paraffin embedded tumor specimen available;
5. Able to tolerate venipuncture for blood draws;
6. Primary diagnosis is not glioma or CNS disease;
7. Both the tumor tissue sample and blood sample pass the quantity and quality parameters to allow for a successful MRD test result.