cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Effects of Multiple Doses of CK-2017357 in Patients With Amyotrophic Lateral Sclerosis (ALS)

The study will generate data on safety, tolerability and pharmacokinetics after multiple daily doses of CK-2017357 in patients with ALS. Patients will be randomized into one of four different treatment groups, receiving daily oral doses of either placebo, 125 mg, 250 mg, or 375 mg of CK-2017357 for 14 days.

In Part A, approximately 24 patients will be randomized to one of four different treatment groups. After a 7-day washout of riluzole, patients in each treatment group will receive daily oral doses of placebo, 125 mg, 250 mg, or 375 mg of CK-2017357 for 14 days. Patients will take daily doses of CK-2017357 or placebo (Day 1 through Day 14) and will return to the study site on Day 2, Day 8 and Day 15. All patients will return for a follow-up visit 7 days (± 2 days) after their last dose.

In Part B, approximately additional 24 patients will be randomized to one of four different treatment groups as in Part A. Patients in Part B will be required to decrease their riluzole dose to 50 mg once a day (QD) for 7 days prior to randomization. After this 7 day period, patients will take riluzole at 50 mg QD concurrently with their morning dose of blinded study drug.

Eligibility Criteria:
Key Inclusion Criteria:

1. Able to comprehend and willing to sign an Informed Consent Form (ICF)
2. Males or females 18 years of age or older
3. A diagnosis of familial or sporadic ALS (defined as meeting the possible, laboratory-supported probable, probable, or definite criteria for a diagnosis of ALS according to the World Federation of Neurology El Escorial criteria)
4. Maximum voluntary grip strength in at least one hand between 10 \& 40 pounds (females) and 10 \& 60 pounds (males)
5. Upright Slow Vital Capacity (SVC) \>50% of predicted for age, height, and sex
6. Able to swallow tablets with water
7. Willing and able to remain off riluzole for 4 weeks (Part A only)
8. Currently taking and tolerating a stable dose of 50 mg BID riluzole (Part B only)
9. Willing and able to reduce daily dose of riluzole to 50 mg for 4 weeks (Part B only)
10. Willing and able to refrain from caffeine-containing products during study participation
11. Willing and able to remain off warfarin and theophylline-containing medications during study participation
12. Has a caregiver who is capable of observing and reporting patient status, and also assisting in the proper use of nocturnal oximetry equipment
13. Able to perform pulmonary function tests

Key Exclusion Criteria:

1. Life expectancy \<3 months
2. Participation in any trial in which receipt of investigational study drug occurred within 30 days or 5 half-lives of the prior agent, whichever is greater, prior to dosing
3. Any prior treatment with CK-2017357
4. Use of non-invasive positive pressure ventilation (NIPPV) for any part of the day or night

Other protocol-defined inclusion/exclusion criteria may apply.
Penicillin and Metronidazole in Treatment of Peritonsillar Abscess

Treatment of peritonsillar abscess varies. To study whether broad spectrum antibiotics are required in addition to abscess drainage, a prospective, double blind, placebo-controlled, randomized study on 200 adult patients with peritonsillar abscess is performed. 100 patients are given penicillin and metronidazole and 100 patients get penicillin and placebo. Recovery and recurrence are analyzed.


Eligibility Criteria:
Inclusion Criteria:

* referring doctor suspects peritonsillar abscess
* patient is voluntary
* patient has daily access to his/her e-mail
* patient speaks and understands Finnish of Swedish
* female patients have adequate birth-control method
* patient has peritonsillar abscess

Exclusion Criteria:

* allergy to penicillin
* allergy to metronidazole
* use of metronidazole in preceding one month
* pregnancy
* breast-feeding
* renal insufficiency
* liver insufficiency
* alcoholism (drunk at least once a week)
* participant in another clinical trial at the moment
* treatment of peritonsillar abscess requires in-patient care
* tonsillectomy during the next 30 days
* army recruit
The Catholic University BIMA Grafting Study

The present study hypothesizes that the systematic use of bilateral internal mammary artery (BIMA) grafting is feasible in the practice of a University Cardiac Surgery Institution for the treatment of multivessel coronary artery disease (primary hypothesis). The secondary study hypothesis is that the BIMA grafting meets the safety endpoint compared with the conventional surgical strategy entailing left mammary artery grafting plus great saphenous vein grafts to revascularize the remaining coronary targets. The tertiary study hypothesis is that the BIMA grafting yields better follow-up results in terms of recurrence of symptoms related to coronary disease, of repeat revascularization and of cardiac mortality compared with patients treated with the conventional surgical strategy entailing left mammary artery grafting plus great saphenous vein grafts to revascularize the remaining coronary targets.


Eligibility Criteria:
Inclusion Criteria:

* Patiens undergoing primary or elective-urgent isolated multivessel Coronary Artery Bypass Grafting (CABG) Surgery

Exclusion Criteria:

* Emergency status
* Previous cardiac operation
* Any associated cardiac procedure other than CABG Surgery
* Left Ventricular Ejection Fraction \<20%
A Study of EGb 761® (Tanakan®) in Dementia of Alzheimer Type Onset in Patients Suffering From Memory Complaints

The purpose of this study is to determine whether Tanakan® is effective at slowing the progression from memory complaint to dementia of Alzheimer's type.


Eligibility Criteria:
Inclusion Criteria:

* Spontaneously reporting a memory complaint
* Short anxiety battery test \< 6, (only if patient screened at GP site)
* Geriatric depression scale \< 15
* Mini-mental state (MMS) \> 25 in GP's office (in hospital site MMS is done as complementary scale)

Exclusion Criteria:

* Objective memory impairment
* Clinician rated dementia staging system \> 0.5
* Mini-mental state \< 25
* Dementia, past history of seizures, Parkinson disease
Tissue Banking Study - Polycythemia Vera or Essential Thrombocythemia (PV & ET) Patients

The purpose of the study is to isolate and characterize stem cells of patients with Polycythemia Vera (PV) and Essential Thrombocythemia (ET) to find out why these cells are not working the way they should be and why they seem to be sensitive to regulatory factors in the blood, such as clotting.

Specific Aim 1: Assess the effects of RG7112 on MPN HSC/HPC p53 levels and study how it affects MPN stem cell function.

Specific Aim 2. Assess the effects of a combination of low doses of IFNα and RG7112 on MPN HSC/HPC.

Eligibility Criteria:
Inclusion Criteria:

* polycythemia vera or essential thrombocythemia
* agree to give blood for study

Exclusion Criteria:

* none
Flexiquit+: Web Program to Promote Smoking Cessation in Sexual and Gender Minority Young Adult Smokers

This phase I trial studies how well Flexiquit+ helps young adult smokers who identify as a sexual and/or gender minority to quit or cut down on smoking. Flexiquit+ is an avatar-led, web-based intervention that can help smokers quit or cut back on how much they smoke cigarettes and/or vape, reducing their chances of developing tobacco-related health conditions.

OUTLINE:

Individuals will be recruited to use the Flexiquit+ program consisting of 6 sessions, each lasting approximately 25 minutes. Participants will also receive text messages providing motivational messages and review information discussed in the program. At the end of the intervention, participants will receive an email with all of the session handouts.

Participants are followed up with at 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Participants must self-identify as a sexual and/or gender minority (i.e., a sexual orientation other than straight and/or gender that doesn't match sex assigned at birth)
* Participants must currently reside in the United States and anticipate remaining in the United States for the duration of the study (2 months)
* Participants must self-report smoking at least 1 cigarette per day in the 30 days prior to screening
* Participants must self-report having at least weekly internet access for the next two months
* Participants must self-report being willing and able to stream video online for this study
* Participants must self-report current use of a personal email account
* Participants must self-report current use of text messaging
* Participants must self-report that they are interested in participating in the study for themselves (versus \[vs\] someone else)
* Participants must self-report that they are not currently taking part in any other smoking cessation treatment such as the nicotine patch, nicotine gum, Zyban, in-person counseling, telephone counseling, using a web-based or app-based cessation program
* Participants must self-report that they have not participated in one of our prior smoking cessation studies, including the user-centered research conducted in the development of Flexiquit+
* Participants must self-report that they are comfortable reading, writing, and speaking English
* Participants must self-report that they understand and agree to the conditions of compensation
* Participants must self-report that they are not currently incarcerated in a prison
* Participants must be willing to use the Flexiquit+ program, complete the study assessments, and sign an online consent form
Clinical Study on a Novel Anti-adhesion Barrier Film

The aim of this clinical study was to verify the effectiveness and safety of the anti-adhesion diaphragm in preventing intrauterine adhesions.

The main questions it aims to answer are

* The efficacy of the anti-adhesion diaphragm in preventing intrauterine adhesions;
* The duration of placement of the anti-adhesion septum in the uterus. Participants will be asked to place an anti-adhesion diaphragm in the uterus for 3-7 days after the abortion procedure. The control group will receive conventional treatment with no other interventions.

The researchers will compare the two groups to see if it is effective in clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily participate in this trial and sign a written informed consent;
* Women aged 18 ≤ age ≤ 40 years;
* Those who had an abortion in early pregnancy, and those who had a cleanse.

Exclusion Criteria:

* Patients with scars;
* Patients with allergies;
* Patients with acute genitourinary tract infections;
* Patients with abnormalities of reproductive organs and abnormal uterine flexion after cesarean section;
* Patients with decreased menstrual flow after previous curettage;
* Patients with previous suspected or diagnosed uterine adhesions;
* Patients on immunosuppressive drugs;
* Patients with long-term use of antibiotics;
* Patients with malignant tumors of the reproductive organs;
* Patients with uterine adenomyosis, endometriosis, and uterine fibroids;
* Patients with severe systemic diseases;
* Patients with other conditions that are not suitable.
Safety, Tolerability, Pharmacokinetics (PK) and Preliminary Efficacy of Tor Kinase Inhibitor in Liver Cancer Patients

The main purpose of the study is to establish a safe dose of AZD8055 in patients with mild or moderate liver disease by providing information on any potential side effects this drug may cause and collecting data about how hepatocellular carcinoma responds to the drug.


Eligibility Criteria:
Inclusion Criteria:

* Advanced stage Hepatocellular Carcinoma (HCC) confirmed by cytology or histology
* Advanced stage Hepatocellular Carcinoma (HCC) or metastatic Hepatocellular Carcinoma (HCC) which is inoperable and incurable with standard available treatments
* Relatively good overall health other than cancer (WHO performance status (0-2)

Exclusion Criteria:

* Patients with severe heart conditions, or those who have had heart surgery such as coronary artery bypass graft within the last 6 months, or patients with uncontrolled high blood pressure despite medical management.
* Patients must not have received any other anti cancer therapy including TACE within 21 days of entering the trial
* Patients must not have received a liver transplant.
Bandage Contact Lenses Versus Eye Patching of Müller's Muscle-conjunctival Resection

Patients with blepharoptosis who are treated with Müller's muscle-conjunctival resection (MMCR) may experience postoperative pain and discomfort related to the suture material on the palpebral conjunctiva. This study aims to compare the postoperative subjective complaints, such as pain and discomfort, with a visual analog scale (VAS) and objectively evaluate the cornea with a tear break-up time (TBUT) test and fluorescein staining following MMCR that was managed by either a bandage contact lens (BCL) or eye patching.

Patients with blepharoptosis who are treated with Müller's muscle-conjunctival resection (MMCR) may experience postoperative pain and discomfort related to the suture material on the palpebral conjunctiva. This study aims to compare the postoperative subjective complaints, such as pain and discomfort, with a visual analog scale (VAS) and objectively evaluate the cornea with a tear break-up time (TBUT) test and fluorescein staining following MMCR that was managed by either a bandage contact lens (BCL) or eye patching.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had unilateral ptosis and underwent unilateral MMCR

Exclusion Criteria:

* Patients were excluded if they had previous eyelid surgery or had another known eye disease, such as ocular surface disorders, dry eye syndrome.
Duloxetine for Chronic Depression: a Double-blind Study

The investigators are studying a new antidepressant medicine, duloxetine, for the treatment of people with chronic depression. Duloxetine (trade name Cymbalta) was recently approved by the FDA for the treatment of major depression. The investigators are testing whether this medicine is also effective for adults with chronic depression (dysthymic disorder or dysthymia).

Chronic depression, lasting two or more years, often causes significant suffering and impairment. The investigators study involves a 6 to 10 week double-blind Initial Phase during which half of the participants will take the new medication and half will take a placebo (an inactive look-alike pill). After the Initial Phase, a 12-week Continuation Phase will begin, during which all subjects can be treated with an FDA-approved antidepressant medication.

Eligible subjects may also receive MRI scans, to help the investigators understand how antidepressants work in treating depression.

This is a 22-week study of the tolerability, dosing, and efficacy of duloxetine in chronically depressed outpatients. Participants can have Dysthymic Disorder (Dysthymia), or Depression, Not Otherwise Specified (Depression NOS).

The first 10 weeks (Acute Phase) are double blind, placebo-controlled, and the second 12 weeks (Continuation Phase) is open-label and all subjects will receive active medication.

Tests of cytokine functioning will be performed and analyzed for treatment and placebo effects.

In addition, a subset of patients will be enrolled into an Magnetic Resonance Imaging (MRI) sub-study, in which a variety of brain imaging techniques (including anatomical MRI, functional MRI (fMRI), MR Spectroscopy, and Diffusion Tensor Imaging) will be performed at baseline and week 10. Duloxetine responders will have a third MRI performed at week 22.

Eligibility Criteria:
Inclusion Criteria:

* age 20 to 75 years (ages 20 to 60 for MRI sub-study)
* diagnosis of dysthymic disorder (chronic depression) or depression NOS
* minimum of 2 years duration of current episode of depression

Exclusion Criteria:

* current major depression
* diagnoses including delirium, dementia, bipolar disorder, schizophrenia
* substance abuse or dependence in the past 6 months
* pregnant or nursing women
* serious risk of suicide
Correlation of FC Gamma RIIIA Receptor Response in Patients With Waldenstrom's Macroglobulinemia

The purpose of this study is to determine if the type of Fc gamma RIIIa receptor that a particular patient's immune cells possess influences how they respond to rituximab and other monoclonal antibodies.

* A medical data collection survey sheet will be filled out by the patient or doctor with medical information pertaining to how the patient responded to rituximab and other monoclonal antibodies for use in this study.
* Blood work will be performed to analyze the blood by molecular technology to find the kind of Fc gamna RIIIa receptor the patient possess and correlate these findings with the outcome of treatment with rituximab or other monoclonal antibodies.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated with rituximab or other monoclonal antibodies for Waldenstrom's macroglobulinemia
Celebrex vs Tramadol in the Treatment of Chronic Lower Back Pain.

This study investigates if Celebrex is as effective as tramadol hydrochloride (Ultram) for patients with chronic low back pain, when administered over a 6-week period.


Eligibility Criteria:
Inclusion Criteria:

* The subject presents with duration of chronic low back pain of \> 3 months requiring regular use of analgesics (\> 4 days/week), except for acetaminophen which cannot have been the sole analgesic used.

Exclusion Criteria:

* The subject has chronic low back pain, which is neurologic in etiology (i.e., radiculopathy, neuropathy, myelopathy)
Reducing Disparities in Chronic Pain Among an Underrepresented Population

Health inequalities in chronic pain exists in the US, with a greater burden of chronic pain and higher rate of misdiagnosis and undertreatment reported in minoritized groups compared to non-Hispanic Whites. Asian Americans (AA) are the fastest-growing racial/ethnic group in the US, yet despite the rapid growth in their numbers, AA remain under-represented in pain disparity research. Cultural norms of Asians may discourage reporting their pain to avoid burdening others or being seen as weak. Rather than seeking medical assistance, Asians have been reported to tend to accept the pain as natural or to suffer to maintain their independence. Very few evidence-based programs are available that can be implemented for this linguistically/socially isolated population in the US. This proposed study aims to fill critical knowledge gaps in pain disparity research by providing evidence of feasibility and acceptability of a culturally-tailored psychosocial pain education intervention for an underrepresented population using the KA community as an exemplar.

Chronic pain is a major population health issue affecting more than 100 million Americans and disparities in chronic pain have been widely documented, indicating minoritized racial and ethnic groups experience a higher burden of chronic pain and are at high risk for undertreatment of that pain. Asian Americans remain underrepresented in pain research; evidence regarding chronic pain experiences of Asian Americans is limited, as are resources and evidence-based programs for this group. This exploratory, developmental study will provide evidence of feasibility and acceptability of a culturally tailored psychosocial education intervention to reduce pain catastrophizing and improve pain outcomes for underrepresented and underserved minority populations.

Eligibility Criteria:
Inclusion Criteria:

1. Female and male
2. ≥ 18 years old
3. Self-reported foreign born Korean Americans
4. Self-reported pain most days of the month for at least 3 months
5. Pain must be non-malignant, but may have more than one pain source

Exclusion Criteria:

1. Having malignant pain (e.g., cancer or HIV-related)
2. Demonstrating significant cognitive impairment (based on results of a cognitive screener-Short Portable Mental Status Questionnaire)
3. Having current, uncontrolled serious psychological disturbance (e.g., schizophrenia, bipolar disorder) or active substance abuse based on self-report
4. Having low literacy skills in Korean or English (unable to understand the written consent and to sign)
5. Undergoing other psychosocial treatment for pain

   * If excluding a population or group that may benefit from the research, please provide justification: We will exclude children. The original intervention (LAMP) trial has established for efficacy in reducing chronic pain outcomes in adult population. Children are not our target population as we focus on developing a culturally tailored chronic pain management program based on LAMP.
Electronic Hand Hygiene Monitoring and ICU Infection Rates

If patients acquire a new infection whilst in hospital this can cause significant morbidity, prolonged hospitalisation and even death. Indeed, there is much public concern about infections such as MRSA. Patients who require intensive care are probably at the greatest risk.

Appropriate hand hygiene by healthcare workers can reduce infection rates and is a key goal of many patient safety initiatives. Worldwide, hand hygiene compliance has been estimated at only 38.7% despite the intervention being simple and cheap. Reasons for poor compliance include lack of time, skin irritation, lack of facilities, intensity of workload and forgetfulness. Furthermore, since cross infection may not be apparent for some days, staff may not associate their (lack of) actions with having caused harm.

Measuring compliance levels enables staff to understand whether they could improve. Direct observation of staff is labour intensive and is not continuous or universal. We will monitor hand hygiene compliance with a newly developed electronic system (MedSense, General Sensing Inc.). We will use the data to provide feedback to the staff in several ways. We hypothesise that comprehensive personalised feedback will reduce healthcare associated infections. We will undertake the study in three intensive care units.

All patients admitted to three intensive care units will be monitored for healthcare associated infections. In parallel the units will be cluster randomised to implement the electronic compliance monitoring in three different ways:

* Unit level feed back every week of current compliance for each of three staff groupings (doctors, nurses, allied health professionals)
* Personalised feedback in the form of an email at the end of a shift stating an individuals performance relative to the average for their professional grouping.
* Real time feedback in the form of a badge worn by the healthcare worker that vibrates when the system thinks they have missed or are about to miss an opportunity for hand hygiene.

All healthcare workers will receive the level of feedback defined in the randomisation for the duration of the three intervention periods. The units will cross-over with an interventing two week wash out period.

All personal feedback will be confidential and private to the individual.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the intensive care units
* All healthcare workers caring for the patients on the intensive care units.

Exclusion Criteria:

* Healthcare workers with skin sensitivity to both alcohol hand rub and soap