cyrilzakka/clinical-trials huggingface dataset:
Translating Research: Patient Decision Support/Coaching

The purpose of the study was to test a telephone counseling intervention for patients after leaving the hospital for a heart attack to use medication, exercise, healthy eating and smoking cessation to prevent further heart attacks.

BACKGROUND: Efficacy of brief individual telephone coaching for secondary prevention behavior has been shown. However, the independent contribution of personal counseling to system-level intervention is untested. We tested a multiple-risk factor brief counseling intervention in acute coronary syndrome (ACS) following hospital-based quality improvement (QI) program.

METHODS: Patient-level randomized trial of hospital quality improvement (QI-only) versus quality improvement plus brief telephone coaching in the first three months post-hospitalization (QI-plus) for patients hospitalized for ACS. Data collection: medical record review, state vital records, and post-hospital surveys (baseline, 3 and 8 months post hospitalization). Main outcomes: secondary prevention behaviors, physical functioning, and quality of life.

RESULTS: QI-plus patients reported statistically significant independent improvements in physical activity (OR = 1.62; p = .01) during the intervention, and were more likely to participate in formal cardiac rehabilitation (OR = 2.51; p = .02). Smoking cessation was not statistically different (OR = 1.31; p = .68); functional status and quality of life were not different at 8 months. Medication use was high in QI and QI-plus groups, and improved over prior cohorts in the same hospitals.

CONCLUSION: QI improved physician and patient adherence to guidelines and improved medical therapy in-hospital continued in the outpatient setting. Brief telephone coaching was modestly effective in accomplishing short-term, but not long-term life-style behavior change. Patient life-style behavior change appears to require sustained intervention. QI-based improvement in medication use improves survival and appears to be the most efficient route to improved outcomes for all patients.

Eligibility Criteria:
Inclusion Criteria:

1. age of 21 years or older,
2. a documented serum Troponin I level of greater than, or equal to the upper limits of normal in each hospital, and
3. a working diagnosis of ACS in the medical record.

Exclusion Criteria:

1. inability to speak English or to complete the enrollment interview, and
2. discharge to a non-home setting.
A Phase Ib/III Clinical Study to Evaluate the Efficacy and Safety of IBI318 in Combination With Paclitaxel Versus Placebo in Combination With Paclitaxel in Patients With Small Cell Lung Cancer Who Have Failed First-line or Above Chemotherapies

This study is a phase Ib/III clinical study to evaluate the efficacy and safety of recombinant fully human anti-programmed cell death receptor 1 (PD-1) and anti-programmed cell death ligand 1 (PD-L1) bispecific antibody injection (IBI318) in combination with paclitaxel versus placebo in combination with paclitaxel in subjects with small cell lung cancer who have failed first-line or above chemotherapies.


Eligibility Criteria:
Inclusion Criteria:

1. Signed the Informed Consent Form;
2. Male or female ≥ 18 and≤75 years of age;
3. Life expectancy ≥ 12 weeks;
4. Pathologically confirmed limited or extensive stage small cell lung cancer according to Veterans Lung Administration Lung Study Group (VALG) staging;
5. At least had progressive disease during or after platinum-based first-line chemotherapy or chemoradiotherapy, and with clear evidence of radiographic progression.

Exclusion Criteria:

1. Previous exposure to immune-mediated therapy; previous use of taxane chemotherapy;
2. Received the last anti-tumor therapy (chemotherapy, radiotherapy) within 4 weeks prior to the first dose of study drug;
3. Received any investigational agent within 4 weeks prior to the first dose of study drug;
4. Received systemic treatment with Chinese herbal medicine indicated for cancer or drugs used for immunoregulation (including thymosin, interferon, interleukin, except for local use for pleural effusion) within 2 weeks before the first dose;
5. Are participating in another interventional clinical study, or observational (non-interventional) clinical study or in the follow-up phase of an interventional study;
6. Pregnant or breastfeeding woman.
Intraoperative Lung-Protective Ventilation in Neurosurgery

The purpose of this study is to explore the effectiveness of lung-protective ventilation during general anesthesia for neurosurgical procedures on postoperative pulmonary outcome, compared with traditional ventilation.

After screened for preoperative risk classification of postoperative respiratory complications,360 patients undergoing elective neurosurgery are randomly assigned to two groups, lung-protective ventilation (L) and traditional ventilation(T).Patients are mechanical ventilated with either a tidal volume of 10-12 ml/kg ideal body weight (IBW,T) or 6-8ml/kg IBW with 6-8 cm H2O PEEP(L),both with recruitment maneuver (RM).Each RM consists of applying a continuous positive airway pressure of 30 cmH2O for 30 seconds. Postoperative pulmonary complications are compared between groups.

Eligibility Criteria:
Inclusion Criteria:

1. \> 40 years ,and \< 80 years
2. Scheduled for neurosurgery
3. After informed consent has been obtained
4. With an expected duration of ≥ 4 hours
5. preoperative risk index for pulmonary complications≥ 2
6. Glasgow Coma Scale \>8

Exclusion Criteria:

1. Mechanical ventilation of \> 1 hour within the last 2 weeks before surgery
2. Body mass index ≥ 35 kg/m2
3. Acute respiratory failure (pneumonia, acute lung injury or acute respiratory distress syndrome)
4. Emergency surgery
5. Severe cardiac disease
6. Progressive neuromuscular illness
7. Pregnancy
8. Refusal to participate
Gastroparesis Registry

The Gastroparesis Registry (GpR) is an observational study to clarify the epidemiology, natural history, clinical course, and other outcomes of gastroparesis.

The Gastroparesis Registry (GpR) is an observational study to clarify the epidemiology, natural history, clinical course, and other outcomes of gastroparesis. The Gastroparesis Registry will also provide a resource to inform the development of clinical trials and ancillary studies of the epidemiology, etiology, pathophysiology, and impact of gastroparesis.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms of gastroparesis of at least 12 weeks duration (do not have to be contiguous) with varying degrees of nausea, vomiting, abdominal pain, early satiety, post-prandial fullness,
* Completion of a 4-hour scintigraphic low fat Egg Beaters gastric emptying study
* Patients with either or both abnormal 2 hour (\>60% retention) and 4 hour (\>10% retention) gastric emptying will be enrolled and classified as definite gastroparesis (Gp)
* Patients with normal gastric emptying, but with symptoms of gastroparesis may be enrolled and classified as possible gastroparesis or gastroparesis-like with normal gastric emptying (GLNGE)
* Age at least 18 years at initial screening visit
* Ability and willingness to participate in follow-up

Exclusion Criteria:

* Inability to comply with or complete the gastric emptying scintigraphy
* Presence of other conditions that could explain the patient's symptoms:
* Pyloric or intestinal obstruction
* Active inflammatory bowel disease
* Eosinophilic gastroenteritis
* Neurological conditions such as increased intracranial pressure, space occupying or inflammatory/infectious lesions
* Acute liver failure
* Advanced liver disease (Child's B or C)
* Acute renal failure
* Untreated chronic renal failure (serum creatinine \>3 mg/dL)
* Total or subtotal gastric resection (patients with prior fundoplication or postvagotomy gastroparesis after pyloroplasty or antrectomy with Billroth I, Billroth II, or Roux-en-Y gastrojejunostomy will be eligible for enrollment)
* Any other plausible structural or metabolic cause
* Any other condition, which in the opinion of the investigator would interfere with study requirements
* Inability to obtain informed consent
Adjunct Targeted Temperature Management in Acute Severe Carbon Monoxide Poisoning

This randomized trial will investigate important neurocognitive clinical outcomes of patients with acute severe carbon monoxide poisoning (ASCOP) randomized to receive either therapeutic hypothermia or normothermia combined with hyperbaric oxygen therapy (HBO).

CO-poisoned patients are identified by medical history and carboxyhemoglobin (CO-Hb) value \>5% (\>10% in smokers). Patients presenting with acute CO poisoning will receive one HBO. ASCOP is defined as mental status showing response to painful stimulus or unresponsiveness requiring intubation for airway protection and ventilation support at the emerency department, and persistence of depressed mental status despite the HBO. After HBO treatment, eligible patients who provide consent will be randomly allocated to receive hypothermia, or normothermia treatment administered in a open label fashion except for blinding of outcome assessor.

Outcome measures will be administered at 1 month and 6 months after CO exposure. In addition, we will examine the differences in serum markers and mortality between the hypothermia and normothermia groups.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 19 years.
* Patients who received HBO within 24 hours for acute CO poisoning.
* Patients who meet the definition of ASCOP (Patients incapable verbal obey after HBO).
* Signed informed consent prior to study entry.

Exclusion Criteria:

* Cardiac arrest before HBO
* Previous neurocognitive disorders
* Life-threatening underlying disease (ex: advanced cancer)
* Evidence of co-ingestion of sedative or hypnotics confirmed by intravenous flumazenil administration or history taking at the emergency department
* Absolute contraindication for TH (active severe bleeding and profound shock not controlled by vasoactive drugs)
* No admission
* The significant co-ingested drug levels, which are alter the consciousness, is confirmed from the drug analysis lab
* Pregnancy
* Burns
* More than moderate burn or Inhalation burn
* Burns complicated by other trauma
* Electrical burn
* Burns in high risk patients (Patients with chronic underlying diseases (i.e DM, ESRD, liver cirrhosis, etc) which may cause delays or aggravate the wound healing)
Study to Evaluate the Pharmacokinetics (PK) of E7090 (Herein Referred to as Tasurgratinib) and Its Metabolite in Participants With Mild and Moderate Hepatic Impairment Compared to Healthy Participants

The primary purpose of the study is to evaluate the effects of mild and moderate hepatic impairment on PK of tasurgratinib after a single dose administration.


Eligibility Criteria:
Inclusion Criteria:

1. Body mass index (BMI) between 18 to 40 kilogram per square meter (kg/m\^2).
2. For Cohorts A and B: stable hepatic impairment conforming to Child-Pugh classification A and B.
3. For Cohort C: healthy participants matched to participants with hepatic impairment with regard to age (+/-10 years), body weight (+/-20 percent \[%\]), race and gender, and as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram (ECG), and clinical laboratory determinations.

Exclusion Criteria:

Key Exclusion for all Participants:

1. Following ocular disorders

   1. Current evidence of Grade 2 or higher corneal disorder
   2. Current evidence of active macular disorder (example, Age-related macular degeneration, central serous chorioretinal disease)
2. Known to be human immunodeficiency virus (HIV) positive at Screening.
3. A prolonged QT/QTc interval (\[QT interval using Fridericia's formula\] QTcF greater than (\>) 480 millisecond \[ms\]) demonstrated on ECG.

Additional Exclusion Criteria for Hepatically Impaired Participants (Cohorts A and B)

In addition to the Exclusion Criteria above for all participants, other standard exclusion criteria for participants with hepatic impairment will be used. These include:

1. Any significant acute medical illness (such as new conditions or exacerbation of pre-existing conditions) within 8 weeks of dosing.
2. Presence of severe ascites, edema, or uncontrolled hepatic encephalopathy
3. The participant's standard therapy/concomitant medication for diseases related to hepatic disease has not remained stable/unchanged for at least two weeks before dosing of study drug.

Additional Exclusion Criteria for Healthy participants (Cohort C)

In addition to the Exclusion Criteria for all participants, other standard exclusion criteria for healthy participants in Phase 1 studies will be used. These include:

1. Syphilis as demonstrated by positive serology at Screening.
2. Any abnormal finding based on physical examination, assessment of vital signs, ECG, or laboratory test results that requires treatment or clinical follow up based on investigators opinion.
Adrenaline During Resuscitation From Pulseless Electrical Activity

This is a prospective observational study at St. Olavs hospital in Norway. Data are gathered from defibrillators that have been in use during resuscitation from cardiac arrest. Aim is to investigate the changes in electrocardiograms (ECG) during resuscitation from pulseless electrical activity (PEA), which is a type of cardiac arrest. ECG changes may be useful as a prognostic marker during resuscitation from PEA. In addition the researchers will describe the effect of adrenaline and chest compressions on clinical state transitions during resuscitation from pulseless electrical activity. Clinical state transitions are changes between different types of cardiac arrest. This study is expected to increase our understanding of the dynamics during treatment of cardiac arrest.


Eligibility Criteria:
Inclusion Criteria: Cardiac arrest among hospitalized patients presenting with PEA as the primary rhythm.
Navigated αTMS in Treatment-resistant Schizophrenia

Since 1990s, stimulation of prefrontal cortex (PFC) has shown therapeutic effects on auditory hallucinations as well as negative symptoms of schizophrenia. However, previous studies have reported mixed or negative results. Majority of the repetitive transcranial magnetic stimulation (rTMS) studies to date has set the target of cortical stimulation based on scalp site. Recently introduced method, navigated transcranial magnetic stimulation (nTMS) integrates the individual MRI data, and thus allows more precise targeting on brain cortical regions enhancing the efficacy of rTMS. Previous EEG studies have suggested reduced alpha band activity in patients with schizophrenia. Some recent studies using alpha (α) EEG guided TMS for treating positive and negative symptoms of schizophrenia have demonstrated promising results.

The aim of the study is to investigate the efficacy of navigated individualized αTMS in treatment-resistant patients with schizophrenia. Approximately fifty patients with DSM-IV schizophrenia will be enrolled in this randomized, double-blind, sham-controlled study. The patients will receive 13 - 15 session of αTMS to the left dorsolateral prefrontal cortex (DLPFC), as adjunctive therapy, for 3 weeks. We assess patients via the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression (CGI) and neurocognitive test battery at baseline, 5 days after and 3 months after treatment. Serum and plasma levels of brain derived neurotrophic factor (BDNF) are assayed at pre and post treatment weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male righthanded inpatients, 18 to 64 years of age
* The diagnosis of Schizophrenia or Schizoaffective Disorder according to DSM-IV
* Capacity and willingness to give informed consent
* Patient is treatment-resistant, CGI-S 4 or more
* Patient is not requiring a change in antipsychotic medication 2 weeks prior to or during treatment
* No foreseeable changes in patient's smoking habits during treatment

Exclusion Criteria:

* Serious somatic illness
* Progressive neurological illness, recent brain damage (less than 3 months ago) or sequela of serious brain damage
* Unstable epilepsy
* Electro convulsive therapy (ECT) less than 3 months prior to treatment
Corneal Astigmatism Measurement Study

To assess which commercially available measurement device is most accurate in measuring low (\< 1.0 D) degrees of corneal astigmatism.


Eligibility Criteria:
Inclusion Criteria:

* 50 years of age and older
* Proof of eye exam within the last 3 months
* Corneal astigmatism of \<1.0 diopter

Exclusion Criteria:

* Prior history of refractive or corneal surgery
* Corneal trauma/disease
* Intraocular surgery
Systematic IPP VS Symptomatic IPP in GERD Prevention After POEM for Achalasia. . A Comparative Retrospective Analysis

POEM is a minimally invasive endoscopic therapy that is highly efficacy in the treatment of achalasia of any type. POEM has an increased risk of GERD. Systematic PPI therapy has never been studied for the prevention of post-POEM GERD.

The investigators wish to retrospectively compare patients who have received routine PPI therapy vs. patients who don't.


Eligibility Criteria:
Inclusion criteria:

* \> 18 years old
* Consent given
* Achalasia all types with eckhardt score \> 3

Exclusion criteria:

* Patient who is a minor or under judicial protection
* Pregnant or breastfeeding woman
* Contraindication to PPIs
* Carrier of mediastinal and exogastric neoplasia
* Patient on PPIs prior to the procedure for indication that does not allow for their discontinuation
* Peptic esophagitis (Grade B, C or D) before or at the time of the procedure
* Previous treatment with Heller myotomy
Combined Use of a Novel Cardioplegic Formula With MPS ® Using the MiECC in Isolated CABG Versus OPCABG

A patient group receiving a novel cardioplegic formula with MPS ® (Myocardial protection system) and using the MiECC (Minimal extracorporeal circulation system) when undergoing coronary artery bypass grafting is compared to a retrospective patient group undergoing Off-pump coronary artery bypass grafting.


Eligibility Criteria:
Inclusion Criteria:

* CABG using MPS® or OPCABG

Exclusion Criteria:

* use of other colloid solution than Cardioplexol ® for MPS®
* other inventions than CABG
* myocardial infarction \<7 days before CABG
* patients denial of data use
Antimicrobial Resistance During the SARS-CoV-2 (COVID-19) Pandemic

Assess the incidence and rates of resistant pathogens prior to and during the COVID-19 pandemic.

The COVID-19 pandemic accelerated/exacerbated resistance rates for key pathogens. Specifically, incidence of extended-spectrum beta-lactamase producing Enterobacteriaceae (ESBLPE), carbapenem-resistant bacteria (CRB), methicillin-resistant Staphyloccoccus aureus (MRSA), vancomycin-resistant Enterococci (VRE), and C. difficile infections (CDI) will be higher in the pandemic time period (Pandemic, March 2020 - February 2025) compared to the pre-pandemic period (Pre-Pandemic, March 2018 - February 2020).

Eligibility Criteria:
Inclusion Criteria:

* • Patients admitted to Methodist Richardson, Methodist Mansfield, Methodist Charlton, or Methodist Dallas Medical Centers between March 2018 and August 2021.

  * \>18 years old

Exclusion Criteria:

* • Outpatient visit

  * Not admitted to an inpatient or observation status
Treatment of Post-Ocriplasmin Therapy Vitreolysis Induced Subretinal Fluid With Eplerenone (Mineralocorticoid Antagonists)

Evaluate the efficacy of eplerenone as an adjunctive treatment to intravitreal ocriplasmin for subretinal fluid in comparison to a control group of only receiving intravitreal ocriplasmin in patients with symptomatic vitreomacular adhesion.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years of age
* Symptomatic VMA, VMT, or macular hole
* BCVA 20/30 - CF 3' Snellen equivalent
* Willing and able to provide signed informed consent and willing to undertake all scheduled study-related assessments, visits, and treatments
* JETREA® treatment naïve

Exclusion Criteria:

* Patients who are pregnant, planning to become pregnant, or breastfeeding a child
* Uncontrolled ocular hypertension or glaucoma in study (defined as IOP ≥ 25mm Hg or a cup to disc ratio (CDR) \> 0.8 despite treatment with anti-glaucoma medication)
* Active malignancies within the last 12 months except appropriately treated carcinoma in situ of the crevices, melanoma, and prostate cancers treated with a curative intent
* Inability to comply with study or follow-up procedures
* Women who may become pregnant or lactating or intend to become pregnant during the study
* Known drug allergy to ocriplasmin or eplerenone
* Patients with known contraindications Eplerenone as outlined in the package insert
Safety Study of a Sensitive Sensual Touch and Personal Lubricant

This is a one week study designed to test the safety of a personal lubricant during in-home use for subjects who perceive themselves as having sensitive skin.

This is a single-center, medically supervised, single-arm study to evaluate the safety of an all over 2-in-1 sensual touch lotion and personal lubricant product in home-use conditions via clinical assessment. The study will consist of two visits. Subjects who meet the entrance criteria will receive investigational product (IP) and four subjective questionnaires for at-home completion. The subjects will be required to use the IP at least two times on each application site, as instructed over the 1-week home-use period. At the end of the study (Visit 2) subjects will return to the study site, at which time all unused IP and questionnaires will be returned and a final clinical assessment will be performed.

Eligibility Criteria:
Inclusion Criteria:

* Normal, healthy adults in a stable, monogamous, ongoing heterosexual relationship with current partner for at least 6 months
* Subjects comfortable discussing sensitive topics such as personal hygiene, menstruation and sexuality
* At least one partner in the couple has sensitive skin per protocol-defined criteria
* Able to read and understand English
* Voluntarily signs an Informed Consent document after the trial has been explained
* Willing to follow all study procedures, including birth control requirements

Exclusion Criteria:

* Any medical or mental health history or condition, or use of any product, drug or medication that per protocol (or in the opinion of the Investigator) might compromise the participant's safety or the analysis of results
* Participation as a research subject within timelines dictated by protocol
* Participants with relationships or employment outside protocol-defined parameters