cyrilzakka/clinical-trials huggingface dataset:
Parallel Arm Trial of AD109 and AD504 In Patients With OSA

This is a phase 2 randomized double-blind placebo-controlled parallel-arm dose finding study to compare fixed dose combinations of AD109 and AD504 to atomoxetine or placebo in Obstructive Sleep Apnea.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 to 65 years of age for men and 18-75 for women, inclusive, at the Screening Visit.
* Mean AHI 10 to 45 events/h, inclusive
* PGI-S: \>1

Exclusion Criteria:

* Current clinically significant sleep disorder other than OSA
* Clinically significant craniofacial malformation.
* Clinically significant cardiac disease (e.g. rhythm disturbances, coronary artery disease or heart failure or hypertension requiring more than 2 medications for control).
* Participants with a history of using devices for OSA treatment, including CPAP, oral or nasal devices, or positional devices, may enroll as long as the devices have not been used for at least 2 weeks prior to first PSG and are not used during participation in the study
An Extension Protocol for Virologically Suppressed Subjects Who Successfully Completed PRO140_CD03 Study

This study is a Phase 2b/3 multi-center extension study designed to evaluate the long term antiviral activity, safety, and tolerability of the strategy of continuing PRO 140 350mg, 525mg, or 700mg SC monotherapy to maintain viral suppression after initial 48 weeks in virologically suppressed subjects.

Consenting subjects will continue weekly PRO 140 350mg, 525mg, or 700mg monotherapy during the Treatment Extension Phase with the one week overlap of existing retroviral regimen and PRO 140 350mg, 525mg, or 700 mg at the end of the treatment in subjects who do not experience virologic failure.

The objective is to assess the long-term safety of using PRO 140 350mg, 525mg, or 700mg SC as single-agent maintenance therapy for the chronic suppression of CCR5-tropic HIV-1 infection.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects who have completed 48 weeks of treatment in PRO140_CD03 study.
2. Last known Plasma HIV-1 RNA \< 50 copies/mL within PRO140_CD03 study.
3. Both male and female patients and their partners of childbearing potential must agree to use 2 medically accepted methods of contraception (e.g., barrier contraceptives \[male condom, female condom, or diaphragm with a spermicidal gel\], hormonal contraceptives \[implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings\], and intrauterine devices) during the course of the study (excluding women who are not of childbearing potential and men who have been sterilized). Females of childbearing potential must have a negative serum pregnancy test at Screening visit and negative urine pregnancy test prior to receiving the first dose of study drug.
4. Willing and able to participate in all aspects of the study, including use of SC medication, completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing written informed consent.

Exclusion Criteria:

1. Not currently enrolled in PRO140_CD03 study.
2. Any active infection or malignancy requiring acute therapy (with the exception of local cutaneous Kaposi's sarcoma).
3. Females who are pregnant, lactating, or breastfeeding, or who plan to become pregnant during the study.
4. Subjects weighing \< 35kg.
5. History of anaphylaxis to any oral or parenteral drugs.
6. History of Bleeding Disorder or patients on anti-coagulant therapy (except aspirin).

   Note: Subjects with well-controlled bleeding disorder while on stable anti-coagulant therapy dose with documented stable INRs can be enrolled as per discretion of the Investigator.
7. Any other clinical condition that, in the Investigator's judgment, would potentially compromise study compliance or the ability to evaluate safety/efficacy.
Telenursing and Remote Monitoring in Idiopathic Pulmonary Fibrosis (IPF)

Numerous studies show that remote monitoring and/or telenursing improves outcomes for patients especially those with chronic diseases. It is proposed that structured telenursing with non-invasive home monitoring of forced vital capacity and oxygen saturation in newly diagnosed patients with IPF will decrease hospitalizations for respiratory illness, increase compliance with therapies, and ultimately increase quality of life.

Patients undergoing evaluation for and who are diagnosed with Idiopathic Pulmonary Fibrosis at Vanderbilt Medical Center from August 1, 2018, will be asked to participate. If agrees, and after signing the consent form, patients will be randomized into one of three arms: Usual Care, Usual Care with Telenursing, or Usual Care with Telenursing and Remote Monitoring. Patients will be asked to remain in the study for a minimum of three years.

Eligibility Criteria:
Inclusion Criteria:

1. Patient must be newly diagnosed with IPF by a Vanderbilt pulmonologist according to the 2011 American Thoracic Society Guidelines. If the patient has been diagnosed by local pulmonologist and started on FDA-approved treatment, then must have been started on treatment within 6 months of Vanderbilt University Medical Center-based diagnosis.
2. Willingness to complete Quality of Life and Compliance Questionnaires at 6-month intervals either via an on-line process (RED Cap survey) or paper-based.
3. Willingness to participate in phone calls/video calls with the nurse practitioner or nurse case manager, if assigned to Arm 2 or Arm 3.
4. Willingness to complete and monitor daily health assessments, if assigned to Arm 3.
5. Willingness to share objective data via a provided electronic web-based portal, electronically via email, fax, or regular mail.
6. Willingness to notify, or allow notification, of study involvement with local pulmonary practices.

Exclusion Criteria:

1. Diagnosed with any other interstitial lung disease.
2. Diagnosed and began treatment \> 6 months before the VUMC-based diagnosis date.
Path2Quit Tobacco Intervention For African Americans

The purpose of this research is to study a smoking cessation program for adult smokers in Northeast Ohio. The study will also look at how different people respond to the program.

The study includes completing surveys and receiving text messages to help participants become tobacco free.

OBJECTIVES Specific Aim 1: Translate a culturally specific video-based tobacco use intervention into a scalable mobile health (mhealth) format.

Specific Aim 2: Conduct a pilot study of the video-text intervention.

Study Design:

2-arm semi-pragmatic randomized design among current tobacco users

Cuyahoga Metropolitan Housing Authority residents will be randomly assigned to receive (1) the newly translated Path2Quit or (2) SmokeFreeText (NCI's publicly available, standard text messaging program) combined with brief behavioral counseling session plus 2 weeks of nicotine replacement therapy (NRT). Primary outcomes will include intervention evaluations (content and format), acceptability, coping strategies, engagement, and NRT adherence. Secondary variables will include 24-hour quit attempts and biochemically verified tobacco use abstinence at the 1-month follow-up. Exploratory mediational analyses will examine the roles of urban hassles, acculturation, neighborhood environment, ethnic discrimination, and psychological distress in intervention effects.

Eligibility Criteria:
Inclusion Criteria:

* Self-identify as African American
* Either smoke at least 1 cigarettes/day or have a carbon monoxide (CO) reading of at least 4 ppm
* Consistent with SmokefreeTXT, be willing to set a quit date within the next 14 days.
* Recruited from Cleveland metropolitan housing authority or who report low income based on federal guidelines

Exclusion Criteria:

* Does not meet all of the above inclusion criteria
Study of Esophageal Squamous Dysplasia Prevalence at Tenwek Hospital

Esophageal squamous cell cancer (ESCC) is common in the developing world, and is the leading cancer diagnosis at Tenwek Hospital in southwestern Kenya. The investigators long-term goal is to understand the pathogenesis and risk factors for ESCC in Kenya, and to establish effective screening and prevention programs. The investigators hypothesize that asymptomatic esophageal squamous dysplasia (ESD) is common in their region, and the current protocol is designed to determine the prevalence of ESD in residents of southwestern Kenya.

The prevalence of esophageal squamous dysplasia will be determined after evaluating pathology reports from unstained lesions and normal biopsies after staining with Lugol's iodine.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 20 years
* No dysphagia (subjects will be asked "do you have trouble swallowing food or water? Do they get stuck inside after you swallow?" in their primary language

Exclusion Criteria:

* Cardiac, respiratory, or metabolic disease that would increase the risk of endoscopy: history of myocardial infarction, arrhythmias, chronic obstructive pulmonary disease, diabetes, allergy to lidocaine.
* Unable or unwilling to provide informed consent.
Interest of Relaxation From Patients With Pain Due to Migraine

The purpose of this study is to determine whether relaxation (autogenic training of Schultz) is effective in treatment for migraine.

This randomized, multicenter study compares 2 parallel groups of patients with migraine :

* I: patients are treated with relaxation + medical treatment (beta-bloquant or Oxetorone)+ patients' education
* II: patients are treated only with medical treatment + patients' education.

Visit 1 : 1 month before randomization for patient's selection and baseline data

Visit 2 (J0): inclusion (randomization) During the first 2 months patients from group I benefit from relaxation consultations.

Visit 3 (2 months after randomization)and visit 4 (4 months after randomization) : evaluation of the efficacy of the two treatment strategies.

Primary endpoint :

- number of days with migraine per month from J0 to visit 4.

Secondary endpoints :

* monthly drug consumption
* percentage of patients who respond (50 % frequency reduction)
* quality of life (SF 36)

Each day, patients note in a notebook if a migraine appears and its intensity.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* 5 to 14 days of migraines per month

Exclusion Criteria:

* Headache by medication abuse
* Patients who already know relaxation technics
* Depression
* Contra indication of using beta-bloquant or Oxetorone
Laparoscopic Surgery Equivalent to Open Surgery in Right Colon Cancer Surgery?

The primary goal of this study is to compare in the long-term costs of laparoscopic or open right colectomy in patients sustaining a colon cancer controling for the carcinologic equivalence of the two surgical strategies. The secondary goals to compare long-term mortality, morbidity as well as quality of life of the two groups.The present study is an prospective multicentric observational trial taking into account the usual surgical strategy of every centers

The aim of the present study is to compare in the long-term costs of laparoscopic and open right cancer colectomy as well as the mortality the morbidity and the quality of life of the operated patients.

The number of patients need to get a 54% power is 300. The average number of patients/surgical center is approximately 27 in 14 surgical centers.

The proposed undertaking of every patient is fully identical to that which is usually proposed by the surgical center in charge of the patient (i.d. 7 centers will perform laparoscopic procedures and 7 centers open procedure according to their usual practice).

A complete information leaflet will be given to the patients during the first consultation which will correspond to the enrollment day.

The preoperative, intraoperative and postoperative period will be in complete accordance with the usual care of the center.

The baseline demographics and conditions as well as the perioperative items and the postoperative occurrences will be recorded through a prior designed e-questionnaire.

The follow-up encompass 5 postoperative consultations:1 month, 6 ,12 ,18 and 24 months.

On every consultation the patient will fill a very simple validated quality of life questionnaire (EORTC,QLQ.C30) an give back a weekly journal reporting the potentially arising medical and surgical events.

Globally the comparative analysis of the costs ,the mortality ,the morbidity, the quality of life ot the patients undergoing either a laparoscopic or a open right colectomy for cancer will be performed controling for the carcinologic equivalence of the two surgical strategies.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old \<= 80 years old
* Right colon cancer \< T4 without metastasis
* \<T4 N0M0

Exclusion Criteria:

* Pregnant patient
* T4 cancer
* Metastasis
Pilot Voice Sample Collection From People With Asthma

Human speech is as unique as a fingerprint and analysing speech had advanced so much that speech can now be used instead of PIN numbers in banking.

The investigators want to find out whether changes in everyday speech can signal the worsening of asthma.

The investigators are planning to collect voice samples from people as their asthma gets better and worse in order to analyse the changes in voice quality - if any.

The participants donating the voice samples will remain anonymous and the voice files will be transferred securely to our analytic system.

Over 18 users of the Smart Asthma app (by Smart Respiratory Products Ltd) will be asked if they wish to participate in the study by recording voice samples. The question will be posed within the app and can be answered with a tap.

Those interested in participating will be shown a short plain English description of the goals and methodology of the project before enrolled.

A maximum of 9 voice sample recording session will be carried out on the phones of participants and take less than 2 minutes each, so participants will spend a total of fewer than 18 minutes during the entire trial.

Sessions will be offered after participants have recorded their asthma symptoms, lung function and inhaler use in the normal course of using the app. Participants may accept or decline each individual offer to record their voice.

Participants will have a chance to play each voice recording before sharing it anonymously with the investigators. Participants can discontinue their participation at any time and can ask investigators to delete all their data.

The investigators will be analyse collected voice samples for changes in voice quality. The changes in voice quality will be compared against changes in lung function and asthma symptoms to determine what changes in voice quality, if any, are indicative of a change in asthma control.

Eligibility Criteria:
Inclusion Criteria:

* Current user of the Smart Asthma app
* Over 18
* Volunteers to participate
* Agrees to terms

Exclusion Criteria:

* None
Comparison of the Efficacy of Ultrasound Guided vs Non-guided Suprascapular Nerve Block Treatment in Stroke Patients

The aim of this study is to compare the effectiveness of ultrasound-guided and non-guided suprascapular nerve block in the treatment of patients with hemiplegic shoulder pain, which is one of the most common post-stroke complications.

Hemiplegic shoulder pain is a general term used to describe shoulder pain that occurs after a stroke. It is one of the complications that significantly affects the rehabilitation of patients.The suprascapular nerve takes up 70% of the sensation of the shoulder joint. For this reason, suprascapular nerve block treatment is applied in the treatment of hemiplegic shoulder pain.In patients with hemiplegic shoulder pain, suprascapular nerve block therapy can be performed under ultrasound guidance or using anatomical landmarks. However, there is no study in the literature comparing the effectiveness of ultrasound-guided and unguided suprascapular nerve block in the treatment of hemiplegic shoulder pain Patients with hemiplegic shoulder pain among the patients who received routine conservative rehabilitation treatment in the physical therapy and rehabilitation clinic with the diagnosis of post-stroke hemiplegia will be included in the study.

Hemiplegic patients aged 25-75 years, with shoulder pain lasting for 3 months and with a Visual Analogue Scale (VAS) value \> 3 during passive shoulder joint movement will be included in the study.

Exclusion criteria from the study will be determined as mini mental test score \< 24, uncontrolled diabetes, coagulopathy, botulinum toxin administration in the last six months, any injection from the shoulder region in the last six months, and hypersensitivity to injection agents.

It will be organized as a prospective randomized study. It is planned to include 50 patients in the study. Patients will be randomized into two groups in equal numbers, stratified by age and sex.

Patients in group 1 will be applied with ultrasound-guided suprascapular nerve block.

Patients in Group 2 will be applied with suprascapular nerve block using defined anatomical points without ultrasound guidance.

Initially, demographic data, medical history, stroke etiology, duration of stroke, body mass index, hemiplegic side information of the patients will be obtained.

Patients in both groups will be evaluated in terms of shoulder joint range of motion, Visual Analogue Scale, Brunnstrom Stages of Stroke Recovery, Barthel Index, Modified Ashworth Scale, The Beck Depression Inventory before the treatment, at the 1st week, 1st month and 3rd month after the injection.

Eligibility Criteria:
Inclusion Criteria:

* Having hemiplegic shoulder pain for 3 months
* Visual analogue scale score \> 3 during passive shoulder joint movement on the hemiplegic side

Exclusion Criteria:

* Mini mental test score \<24
* Patients with uncontrolled diabetes, coagulopathy
* Botulinum toxin administration in the past six months,
* Any injection in the shoulder region in the last six months
* Having hypersensitivity to injection agents
A Genotype-Phenotype Urothelial Cancer Registry

This study is being done to create a registry to help us learn more about urinary and other cancers. This will let us look at large groups of people who do and do not have this kind of cancer.

The investigators will look at risk factors to learn more about how these impact cancer. The investigators will also look at genetic markers. These are genes that are found in a known place. They are often associated with a particular trait. If the gene changes in some way, it may predict cancer or response to treatment. The investigators will look for markers in your saliva.

This registry will help us develop better methods of:

Preventing these cancers. Diagnosing these cancers. Treating these cancers.


Eligibility Criteria:
Inclusion Criteria:

Urothelial Cancer Cases

* Must be ≥ 18 years of age AND
* Must have a diagnosis of urothelial cancer AND
* Must be an English-speaker

Non-Cancer Control Group

* Must be ≥ 18 years of age AND
* Must not have cancer or a personal history of cancer, with the exception of skin cancer. AND
* Must not be a blood relative of cases AND
* Must not be a blood relative of another control AND
* Must be an English-speaker

Family Member Control Group:

In select kindreds with a high prevalence of bladder cancer and/or very early onset bladder cancer, first- and second-degree family members of probands may be contacted by the MSKCC study team and invited to complete the questionnaire and submit a saliva sample.

* Must be ≥ 18 years of age AND
* Must be a blood relative of a case participant AND
* Must be an English-speaker

Exclusion Criteria:

* Have any condition, which in the opinion of the primary MSKCC clinician or investigators precludes their ability to provide informed consent.
Utility of Vancomycin Loading: A Pharmacokinetic Analysis in Critically Ill Patients

The goal of this clinical research study is to learn if giving a larger than normal "loading dose" of the antibiotic vancomycin before starting standard vancomycin dosing can help patients reach and maintain the needed blood-level of the antibiotic during treatment.

The Study Drug:

Vancomycin is an antibiotic used to treat serious, life-threatening infections caused by bacteria. Researchers want to find the best and most effective dose and blood-level of the drug that may have the best effect against bacteria.

Study Drug Administration:

If your doctor believes you are eligible, and you agree to take part in this study, you will be given a "loading dose" of vancomycin that is about twice as large as the standard dose. The dose amounts will be based on your body weight. Doses can be given every 8-12 hours, depending on your level of kidney function.

Study Procedures:

Blood (about 1 teaspoon each time) will be drawn for pharmacokinetic (PK) testing and to check your kidney function. PK testing measures the amount of study drug in the body at different time points. PK blood samples will be drawn just after the loading dose, and then just before each standard dose of vancomycin (up to 5 samples total). When possible, the PK sample may be drawn through a central venous catheter or line you already have placed, to avoid extra "needle sticks."

The study staff will collect information about your health and any side effects you may be having for 7 days.

Length of Study:

Treatment with vancomycin may be stopped early if you experience intolerable side effects or the doctor thinks you can stop taking the drug early.

This is an investigational study. Vancomycin is FDA approved and commercially available for use in treating bacterial infection. The use of a loading dose for vancomycin is investigational.

Up to 10 patients will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Admission to MD Anderson Cancer Center Surgical Intensive Care Unit (SICU) under the Thoracic Surgery physician group
2. Intravenous vancomycin therapy deemed necessary

Exclusion Criteria:

1. Age less than 18 years
2. History of hypersensitivity to vancomycin
3. Patient weight greater than 150 kg
4. Receival of 1 or more doses of the following agents within 72 hours prior to screening: amphotericin B (lipid, liposomal, or conventional formulation), aminoglycosides, foscarnet and/or intravenous contrast dye.
5. Prior exposure (within 7 days) to intravenous vancomycin
6. Current renal insufficiency defined as baseline Scr \>/= 1.5 mg/dL, or increase in baseline serum creatinine (SCr) by \>/= 0.5 mg/dL within the last 2 days, or estimated creatinine clearance (CrCl) \</= 30 mL/min by Cockcroft-Gault equation.
7. Current need for hemodialysis or continuous renal replacement therapy
Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE)

The purpose of this study is to see if bempedoic acid (ETC-1002) is safe and well-tolerated in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately controlled by their current therapy.


Eligibility Criteria:
Inclusion Criteria:

* Successfully completed CLEAR Harmony (1002-040) parent study

Exclusion Criteria:

* Experienced a treatment-related SAE that led to study drug discontinuation in the CLEAR Harmony (1002-040) parent study.
* Medical condition requires lipid measurement and/or adjustment of background lipid-regulating therapy.