cyrilzakka/clinical-trials huggingface dataset:
Philippine Neurological Association One Database - Stroke

This is a pragmatic, multi-center, prospective, observational, non-interventional study and standing database of patients hospitalized for transient ischemic attack (TIA) or stroke in the 11 accredited adult neurology training institutions in the Philippines. Data will be collected from each patient while admitted in the hospital and until hospital discharge. Data collection for this study will span 3 years from study initiation, after which the utility of an extension or a re-implementation of the study will be assessed.

Primary objective is to prospectively collect data on demographics, medical history, in-hospital management, and outcomes among patients with first or recurrent TIA or ischemic or hemorrhagic stroke admitted in accredited adult neurology training institutions in the Philippines.

Secondary objectives are:

1. To determine the in-patient case load of first and recurrent TIA and stroke.
2. To determine the profile of patients admitted for first or recurrent TIA or stroke.
3. To determine the types of diagnostic and therapeutic management received by patients with first or recurrent TIA or stroke.
4. To determine the outcomes of patients with first or recurrent TIA or stroke at the time of hospital discharge.
5. To evaluate factors that predict outcome among patients with first or recurrent TIA or stroke.
6. To assess and audit the overall quality of care received by patients admitted for first or recurrent TIA or stroke.
7. To perform other future analyses, sanctioned by the Philippine Neurological Association (PNA), that may improve knowledge on the care of patients with first and/or recurrent TIA or stroke.

All eligible patients will be assigned a study identification (ID) number and included in the site log kept confidentially in each site. Corresponding anonymized data on demographics, medical history, stroke sub-type, in-hospital management and discharge outcomes will be collected from each patient and entered in the database using a secure online data collection tool.

Collective data will be extracted, summarized, and analyzed for the secondary objectives every year with oversight provided by the Philippine Neurological Association.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of first or recurrent TIA, ischemic or hemorrhagic stroke, or cerebral venous thrombosis (CVT)
2. 18 years old or older
3. Admitted in the participating hospital
4. If required by the institutional review board/ethics committee, signed or verbal informed consent for participation in the study from the patient or a legal representative

Exclusion Criteria:

1. Patients with previous TIA or stroke who are admitted to the hospital for medical conditions other than an acute stroke, e.g., patient with non-acute stroke admitted for pneumonia, rehabilitation, or procedures, such as gastric tube insertion, etc.
2. Any condition which, in the study investigator's opinion, may jeopardize the patient by his/her participation in this study or affect the validity of the study results
ONO-7436 Phase II Study in Japan

The purpose of this study is to examine the efficacy and safety of ONO-7436 for the prevention of cancer chemotherapy-induced nausea and vomiting in patients with malignant tumor


Eligibility Criteria:
Inclusion Criteria:

1. Patients age 20 years or older
2. Patients with malignant tumor who are to be intravenously administered cisplatin as a single dose of 70 mg/m2 or more in under 3 hours
3. Patients whose performance status is 0 to 2
4. Other inclusion criteria as specified in the study protocol

Exclusion Criteria:

1. In case of patients who are previously treated with cisplatin, those having no past history of vomiting as of administration of cisplatin
2. Patients who had vomiting or dry vomiting within 24 hours before the initial administration of the moderate or severe emetic chemotherapy (including cisplatin) on Day 1 of the study
3. Pregnant women, nursing women, women of child-bearing potential, women who wish to become pregnant or women using oral contraception
4. Other exclusion criteria as specified in the study protocol
Educational Program Through Video Conference for Inhaled Therapies in Cystic Fibrosis Patients

Educational programs are essential for cystic fibrosis patients who need to take several different drugs every day. Compliance is often klow in these patients, and clinicals and paramedics try to increase it, through educational programs. As for inhaled therapies, the CF center of Montpellier uses a video conference tool to educate patients. The program may involve either the physiotherapist or the doctor or both. Through the present study, the investigators would like to evaluate the current practice at the CF center of Montpellier and verify if patients feel that the physiotherapist could handle the program on his own, without the support of a physician.


Eligibility Criteria:
Inclusion criteria:

* CF patients
* patient regularly assessed at the CF center of Montpellier
* major patients
* patients who recently enrolled a video conference educational program or who will soon be part of it

Exclusion criteria:

* patients not able to participate to a video conference educational program, due to lack of tools at their home
Comparison of the Incidence of Inadequate Epidural Analgesia Between Protocol Based and Current Practice

Epidural analgesia is the recommended analgesic technique in patients having surgery with severe postoperative pain such as thoracic and upper abdominal surgery. However, from the previous study, the incidence of inadequate pain control in patients receiving epidural analgesia is very high 48.6% in our hospital.

A high incidence of inadequate epidural analgesia may result from variety of epidural techniques and epidural drug administrations. The protocol based practice has been developed from acute pain service which founded for more than 10 years. By using protocol based practice, the investigators believed that the incidence of inadequate epidural analgesia will be less compared with the current practice.

Eligibility Criteria:
Inclusion Criteria:

* All patients age ≥ 18 years old undergo surgery with epidural catheter insertion at Siriraj hospital.

Exclusion Criteria:

* Coagulopathy
* Allergy to study drugs: local anesthetics and opioids
* History of chronic pain
Clinical Outcomes of Patients With Deferred Revascularization Based on FFR and iFR Negative Coronary Artery Lesions.

The objective is to assess long-term clinical outcomes of patients in whom intervention of coronary lesions was deferred due to negative fractional flow reserve (FFR) and negative Instantaneous wave-free ratio (iFR) in a real-world patient population and to identify factors associated with deferred target lesion failure.

Fractional flow Reserve (FFR) evaluates functional significance of stenosis in intermediate coronary lesions. Instantaneous wave-free ratio (iFR) is considered noninferior to FFR and does not require adenosine administration.

This study was done to assess long-term clinical outcomes and factors associated with target vessel revascularization (TVR) in patients with deferred revascularization based on negative FFR and iFR.

Retrospective analysis of medical records of 345 patients with deferred revascularization at a tertiary care hospital , from January 2012 to January 2020 will be done.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had intermediate to severe coronary lesions on coronary angiogram.
* Patients who had negative FFR \>0.80 or iFR \>0.89 and did not undergo immediate or planned revascularization on basis of negative physiologic assessment.

Exclusion Criteria:

* Patients younger than 18 years of age or those having positive FFR/iFR values irrespective of revascularization status were excluded.
* Similarly, those who were lost to follow up and could not be traced via telephonic or were also excluded.
Testing a Novel Instagram Intervention for Heavy Alcohol Use

This project aims to test the efficacy of an Instagram-based intervention for reducing heavy alcohol use. More specifically, the investigators will use a randomized controlled design to analyze differences in alcohol use and alcohol-related outcomes (e.g., alcohol-related consequences, etc.) as well as differences in the use of protective behavioral strategies and mindfulness practices. Participants (80 Prolific users who report binge drinking) will be randomly assigned to 1 of 3 conditions: intervention or control. Those who are randomized to the intervention condition will be invited to follow study Instagram pages, and those who are randomized to the control condition will be invited to complete the assessments only. The investigators hypothesize that there will be greater reductions in alcohol use, frequency, and consequences and greater frequency of use of mindfulness exercises and protective behavioral strategies among those in the intervention condition as compared to those in the control condition.


Eligibility Criteria:
Inclusion Criteria:

* Ages 18-30
* Report regular Instagram usage (i.e., at least a few times a week)
* Report having met the NIAAA's criteria for a binge-drinking episode (4+ drinks in a sitting for cisgender women, 5+ drinks in a sitting for all other genders) at least twice a month for the past three month

Exclusion Criteria:

* No exclusion criteria
Mechanical Cardiopulmonary Resuscitation During Treatment of Acute Respiratory Failure Through Extracorporeal Membrane Oxygenation.

In-hospital cardiovascular arrest is associated with poor outcome despite prompt treatment and optimal on-site resources. The population of patients treated by venovenous extracorporeal membrane oxygenation (vv-ECMO) due to pulmonary failure is a very challenging group of patients. To date, the frequency, causes and outcome of cardiovascular arrest in these patients have not been studied. We are aiming to conduct a retrospective observational study of all vv-ECMO patients treated at our ARDS centre.


Eligibility Criteria:
Inclusion Criteria:

Patients treated with veno-venous extracorporeal membrane oxygenation (vv-ECMO) due to respiratory failure during acute respiratory distress syndrome (ARDS).

Exclusion Criteria:

Patients treated with veno-arterial extracorporeal membrane oxygenation (va-ECMO)
Educational and Supportive Interventions to Prevent Cardiopulmonary Rehospitalization

This study will use a comprehensive hospital discharge toolkit to implement up-to-date guidelines for cardiopulmonary diseases. The study will also include a computer-based patient-education program and a telephone-based post-discharge program, both designed for individuals with limited health literacy. The purpose of this study is to reduce early hospital readmission.

BACKGROUND:

Limited health literacy is prevalent in America and has been identified as a cross-cutting priority area for transforming health care quality. This study will explore the effect of innovative patient-education and self-management systems on early rehospitalization for patients admitted to a general medical service.

DESIGN NARRATIVE:

This is a two-armed randomized study of patients with chronic cardiopulmonary diseases in three levels of health literacy. Patients will be tested with the 66 word version of the Rapid Estimate of Adult Literacy in Medicine (REALM) test to allow us to analyze the data according to literacy categories ( 6th grade, 7th-8th grade, and 9th grade). Patients will be randomized to one of the following groups: 1) standard discharge (control group); 2) a experimental group receiving both the case management intervention plus educational and self-management support by Embodied Conversational Agents (ECAs) and post-discharge reinforcement of the discharge plan using a computerized telephone system

Eligibility Criteria:
Inclusion Criteria:

* Admitted to the general medical service at Boston Medical Center (BMC)
* Desires to be hospitalized in the future if there is a clinical need
* Able to communicate in English with health providers

Exclusion Criteria:

* Transferred from an outside hospital or a specialty services at BMC (e.g., orthopedic surgery, obstetrics and gynecology, otolaryngology, general surgery, or psychiatry)
* Requires hospice, nursing home, or other institutional settings
* Vision that is inadequate to discern the computer-based education and self-management support system
* Hearing that is inadequate to use a telephone
* Unable to independently consent
* Scheduled admission (e.g. for surgery)
* Has sickle cell disease
L-Carnitine L-Tartrate in Preventing Peripheral Neuropathy Caused By Chemotherapy in Women With Metastatic Breast Cancer

RATIONALE: L-carnitine L-tartrate may prevent peripheral neuropathy caused by chemotherapy.

PURPOSE: This randomized clinical trial is studying how well L-carnitine L-tartrate works in preventing peripheral neuropathy caused by chemotherapy in women with metastatic breast cancer.

OBJECTIVES:

* To evaluate the tolerability and usefulness of the dietary supplement, L-carnitine L-tartrate, in the prevention of chemotherapy-induced peripheral neuropathy in women with metastatic breast cancer.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral L-carnitine L-tartrate twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.
* Arm II: Patients receive oral placebo twice daily beginning on day 2 of the first course of chemotherapy and continuing until after completion of 4 courses of chemotherapy.

Patients complete questionnaires periodically to assess neuropathy, pain, fatigue, sleep, and activities of daily living.

After completion of study treatment, patients are followed at 4 weeks and then every 3 months thereafter.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer

  * Metastatic disease
* Scheduled to receive ≥ 1 of the following chemotherapy drugs:

  * Paclitaxel
  * Docetaxel
  * Capecitabine
  * Gemcitabine hydrochloride

    * Concurrent enrollment in the University of Minnesota study "Population Pharmacokinetics and Pharmacogenetics of Gemcitabine in Adult Patients with Solid Tumors" (Human Subjects Code 0508M72989) required
  * Albumin-bound paclitaxel (Abraxane)
  * Doxorubicin hydrochloride

PATIENT CHARACTERISTICS:

* Life expectancy ≥ 6 months
* Serum creatinine \< 2.0 mg/dL
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No history of seizures
* No uncontrolled hypertension
* No history of stroke
* No malabsorption syndrome
* No cognitive impairment
* No history of psychiatric disability affecting informed consent or compliance with drug intake
* Able to take oral medication
* Able to complete questionnaire(s) alone or with assistance

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No concurrent warfarin
* No concurrent radiotherapy
Comparing Differing Financial Incentive Structures for Increasing Antidepressant Adherence Among Adults

The investigators will test using financial incentives by leveraging decision-making biases to improve adherence to antidepressants among adults newly prescribed antidepressants. This study will compare the effects of usual care, increasing financial incentives, and decreasing financial incentives on daily antidepressant medication adherence and depression symptom control of non-elderly adults with Major Depressive Disorder.

A three arm randomized controlled trial will compare interventions to promote antidepressant adherence. One hundred twenty adults with major depressive disorder (MDD) who are initiating antidepressant treatment will be randomized in equal proportion to 1) usual care, 2) usual care and an escalating daily financial incentive for 6 weeks, or 3) usual care and a de-escalating financial incentive for daily antidepressant adherence for 6 weeks. Study patients will participate in three assessments over a 12 week period as well as passive monitoring of antidepressant daily adherence through a wireless electronic pill bottle over the same 12 week period. The primary outcome will be the number of antidepressant daily doses taken during the initial six weeks of treatment. The secondary outcome will be daily adherence during the next six weeks following the discontinuation of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Prescribed antidepressant
* Plan to take antidepressant as prescribed
* Working cell phone that allows texting
* Score on PHQ-9 ≥ 10

Exclusion Criteria:

* No antidepressant use in last 90 days
* Never been diagnosed with bipolar disorder, schizophrenia, or schizoaffective disorder
* Not currently pregnant or breastfeeding
* No other serious medical condition
Acute Pain and Inflammation After Surgery

The purpose of this study is

1. to observe acute pain after surgery and measure the natural course of inflammatory mediators
2. study pain relieving effects and local anti-inflammatory effects of systemically administered ketorolac

Randomizized controlled trial

Eligibility Criteria:
Inclusion Criteria:

* Day case surgical patients above 18 years old
* Non pregnant

Exclusion Criteria:

-
Pain AND Opioids After Surgery

The aim of this study is to document the perioperative opioid use and its safety in the UK and countries in Europe and to describe its association with surgical complications, persistent pain and quality of life. In an international, prospective, observational cohort study, data about the perioperative pain management will be collected in all eligible hospitalised adult patients who undergo surgery in a designated "study week" in as many hospitals as possible in Europe. Baseline data will be collected, and participants followed up at one week, and at three and twelve months post-operatively. The primary outcome will be opioid use at three months after surgery. Secondary outcomes will include opioid use during the preoperative month (preoperative use), during surgery and up to one week after surgery (or discharge, whichever is earlier), and up to the end of the postoperative year. Additional secondary outcomes are the incidence of preoperative pain, persistent pain with/without the presence of neuropathic components, quality of life and surgical complications. The potential association between opioid use and pain outcomes will be investigated. This study could help to develop strategies to improve quality of care, through pain management, for patients undergoing surgery.

PANDOS is an international, prospective, observational cohort study. In a one week period (the designated "study week"), data will be collected in all eligible hospitalised adult patients who undergo surgery in as many hospitals as possible in the UK and Europe. Participants will be followed up for 12 months

Eligibility Criteria:
Inclusion Criteria:

* hospitalised adult patients (18 years and older) undergoing any inpatient surgery (elective or emergency) during the designated study week where an anaesthetist is involved (general anaesthetic, sedation, local anaesthetic).

Able to understand and has capacity to give written informed consent

Exclusion Criteria:

* American Society of Anaesthesiologists (ASA) grade V or VI
* Refusal to participate.
* Lack of comprehension of validated questionnaires or inability to complete the follow-up for any reason.
* Lack of capacity to give written informed consent
Myocardial Infarction and Current Oral Contraceptive Use

To assess whether current oral contraceptive (OC) use (within the previous month) increased the risk of myocardial infarction. Also, to assess the combined effects of cigarette smoking and oral contraceptive use.

BACKGROUND:

It has been established that oral contraceptive formulations used in the 1960s and 1970s increased the risks of myocardial infarction, venous thromboembolism, and stroke. Oral contraceptive formulations have changed, as have prescribing practices, and there was a need for information on the effects of the newer formulations in use. Myocardial infarction is the most important cardiovascular disease in terms of the incidence and mortality attributed to use of oral contraceptives; although the overall incidence of myocardial infarction is relatively low in women of childbearing ages, the incidence is not low in smokers.

DESIGN NARRATIVE:

A case-control design was used. The case series consisted of women 18 to 44 years of age admitted for a documented first myocardial infarction to any of 100 collaborating hospitals in Massachusetts, Rhode Island, and Pennsylvania. Nurse interviewers administered standard structured questionnaires to cases and controls on drug use, race, religion, medical history and myocardial infarction risk factors. Information was collected on: cigarette smoking; histories of hypertension, diabetes mellitus, angina, abnormal plasma lipids; reproductive and menstrual histories; alcohol and coffee consumption; personality type using the Framingham Type A scale; family history of myocardial infarction; exercise; education and occupation of the patient and her spouse. Information was also obtained on the timing and duration of oral contraceptive use. The effect of oral contraceptive use was considered among nonsmokers, light smokers, and heavy smokers. Individual oral contraceptive formulations were classified according to dosage and type of estrogen, formulation type, and other groupings. Multiple logistic regression analysis with fitting of the regression equations by the method of maximum likelihood was used for simultaneous control of all potential confounding factors.

The study was renewed in 1995 to continue data collection to establish the effect of triphasic OCs on MI risk, with particular attention to the joint effect with heavy smoking. The new data collection also permitted more definitive analysis of the effect of monophasic OCs. Triphasic formulations have become popular and in 1995 accounted for about half of OC use. There were not enough users of triphasic OCs in the present study for informative analysis, nor were there any data from other studies on this issue. The study ended in December, 1999.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Therapeutic Effects of Berberine in Patients With Type 2 Diabetes

The purpose of this study is to determine whether berberine is effective in the treatment of type 2 diabetes.

Type 2 diabetes is health threats worldwide. However, treatment of this disease is limited by availability of effective medicines. All of the existing oral hypoglycemic agents have secondary failure after long term administration. Thus, new oral medicines are needed for long term control of blood glucose in patients with type 2 diabetes. In diabetes care, dietary approaches have drawn more and more attention in the prevention and treatment of hyperglycemia. Generally regarded as safe (GRAS) plants have been widely used for their benefits in antioxidation, anti-inflammation, anticancer, anti-obesity and anti-diabetes. Numerous botanical products such as pigments that include anthocyanins and flavonoids have been consumed or studied for anti-obesity and anti-diabetes. However, most of these botanical products are mixtures of multiple compounds. It is difficult to control their quality in the study or production. Up to now, as a single purified compound, berberine is demonstrated to have hypoglycemic effect in vitro and in vivo. Berberine is the main active component of Coptis chinensis French, which was used for thousands of years in China in the treatment of human diseases including diabetes.

Comparison(s): Effects of berberine compared with metformin in newly diagnosed type 2 diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes
* HbA1c \> 7.0% or FBG \> 7.0 mmol/L
* Stable or worsening glycemic control for at least 3 months

Exclusion Criteria:

* Liver damage
* Kidney damage