cyrilzakka/clinical-trials huggingface dataset:
Use of Intraoral Suction and Its Effects on Obstructive Sleep Apnea

To learn whether stabilization of the tongue using intraoral suction is tolerable and what effects this approach has on sleep parameters in obstructive sleep apnea.

Patients who are newly diagnosed with moderate OSA or diagnosed with OSA in the past 5 years and who are not compliant with continuous positive airway pressure treatment will be identified from the Boston VA Healthcare Sleep Laboratory database and invited to participate in the study. Those patients interested in participating will be consented and then evaluated for adequate nasal patency and oral dentition to assess their eligibility for the study. This is a pilot study primarily assessing tolerability of using intraoral suction to stabilise the tongue at night as well as its effects on sleep parameters. Target enrollment is 40 patients. Those enrolled will have a digital intra-oral scan performed and a custom-fit mouthguard that can transmit low level intermittent suction fabricated. The participant will wear this mouthguard for up to five consecutive nights. They will complete a survey designed to assess tolerability following five nights of wearing the mouthguard. The participant will then have a two night in-hospital polysomnography performed one night with the mouthguard transmitting suction and a second night with no suction. The outcomes will be measured using the tolerability survey scores and the duration and quality of sleep as measured by polysomnography.

Eligibility Criteria:
Inclusion Criteria:

Age 18-80

Patients newly diagnosed with OSA (a diagnosis of OSA ≤6 months) who may or may not have started using their PAP yet

Patients diagnosed \> 6 months but within the past 5 years who are not compliant with positive airway pressure treatment. Non compliance is defined as use of device for an average of \<4 hours/night OR \< 5 nights/week

An AHI, REI or RDI or any synonymous term for AHI in the moderate to severe range (15-60)

A body mass index (BMI) less than \<=40 (BMI within 1 year of enrollment date)

Adequate dentition to support a dental retainer

Exclusion Criteria:

Evidence of central sleep apnea or concomitant sleep disorder other than OSA

Currently using MAD or other form of mouth prosthesis to treat OSA

Prior surgical treatment for OSA

History of anatomic nasal obstruction

Use of medications that may affect sleep (hypnotic medications for the treatment of insomnia)

Use of pacemaker or implantable cardioverter-defibrillator (ICD)

Immunocompromised (i.e., susceptible to infection)

Open soars/wounds in patient's mouth

Active alcohol abuse or IV drug use
Comparison of Postprandial Glucose Control Associated With BIOD-531 vs. Humalog Mix 75/25 vs. Humulin R U-500

The study is to compare meal time glucose control associated with BIOD-531, a rapidly absorbed concentrated insulin to that associated with Humalog Mix 75/25 and Humulin R U-500.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* BMI \> 25 kg/m2
* Type 2 Diabetes Mellitus
* HbA1c \< 10.0%
* Subject uses 50-200 units of insulin/day

Exclusion Criteria:

* Type 1 Diabetes Mellitus
* History of bariatric surgery
* Corticosteroid therapy
* Significant cardiovascular or other major organ disease
* Females who are breast feeding or pregnant
* A sexually active person not using adequate contraceptive methods
Differences in Immunologic Response to Cryoablation Versus Radiofrequency Ablation in the Treatment of Renal Cell Carcinoma

The purpose of this study is to compare changes in the body's self-defense (immune response) after two different treatments for small kidney tumors: 1) Cryoablation (freezing) therapy in which the tumor and a margin of normal kidney tissue are frozen and thawed twice with a needle probe and 2) radiofrequency ablation (RFA) in which radiofrequency energy delivered through a needle probe is used to heat tissue and thereby destroy a tumor.


Eligibility Criteria:
Inclusion Criteria:

* You are eligible to participate in this study if you are an adult (older than 18 years)
* Diagnosed with renal cell cancer 1-3 centimeters in size on the CT scan.

Exclusion Criteria:

* You are not eligible to participate in this study if you are immune compromised (chemotherapy,corticosteroid use, HIV \[as documented in your medical record\], etc.)
* Have an autoimmune disorders (Rheumatoid arthritis, Crohn's disease, etc)
* Have a tumor larger than 4 cm
* Are pregnant.
Safety and Efficacy of PG102P for Uremic Pruritus in HD Patients

In this study (SNUG trial), the investigators aim to investigate the anti-pruritic effect of PG102P in comparison with placebo in 80 patients undergoing HD.

This is a multicenter, randomized, double-blind, placebo-controlled trial in which one group will be treated with PG102P (1.5 g/day) and the other with a placebo. It is an investigator-initiated clinical trial. A superiority trial is planned to test the hypothesis that PG102P is effective in relieving pruritus for patients with ESRD undergoing HD.

Eligibility Criteria:
Inclusion Criteria:

1. Age over 19 years
2. Patients with adequate HD (Kt/V \> 1.2)
3. Maintenance patients undergoing HD with chronic pruritus
4. Mean visual analog scale (VAS) over 4 of the last 5 days in the 14-day pre-observation period
5. Participants who allowed to continue the anti-pruritic drug treatment at the same dosage and administration schedule as used at baseline throughout the study period
6. Patients who agreed to participate in this trial and had written an informed consent

Exclusion Criteria:

1. Intact parathyroid hormone (iPTH) \> 1000 pg/mL within 1 month
2. Serum potassium \> 7.0 mg/dL
3. HIV Ab (+)
4. Aspartate transaminase (AST) (glutamic oxaloacetic transaminase) or alanine transaminase (ALT) (glutamic pyruvic transaminase) \> 3 times the upper limit of normal
5. Scheduled to have kidney transplantation within 3 months
6. Cancer history with current treatment
7. Active infection with current treatment
8. Current itching with dermatologic diseases other than uremic pruritus
9. Pregnancy, childbearing potential during the study period, or breastfeeding
10. Allergy or hypersensitivity reaction to PG102P
11. History of participating another clinical trial within 2 months or planning to participate another clinical trial
12. Not eligible to participate this trial as researchers' decision
Dose Response Study of AL-37807 Ophthalmic Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension

The purpose of thie study is to compare the safety and IOP-lowering efficacy of AL-37807 Ophthalmic Solution 0.05%, 0.1% and 0.2% dosed QD AM to Xalatan dosed QD PM and Vehicle in patients with open-angle glaucoma or ocular hypertension


Eligibility Criteria:
Inclusion Criteria:

* Open-angle glaucoma
* ocular hypertension

Exclusion Criteria:

- VA worse than 0.60
Effect of Transcutaneous Electrical Nerve Stimulation and Cupping Therapy in The Treatment of Tennis Elbow: A Randomized Controlled Trial

One hundred and twenty patients (67 females and 53 males) with unilateral TE were included in the study from January 2020 to December 2020 and diagnosed by an orthopedist. Their ages ranged between 20 and 50 years old.

They were divided randomly into three groups by lottery method. Group A (n=30) received conventional therapy, group B (n=30) received TENS in addition to conventional therapy, group C received cupping therapy with conventional therapy and group D (n=30) received TENS and cupping therapy plus conventional therapy. All patients read and signed a consent form before participation in this trial. This study was approved by the Ethical Committee of the Faculty of Physical Therapy, October 6 University, Egypt. Patients with pain in the lateral epicondylar region, increased pain with pressure and resistance to wrist extension, persistence of symptoms for more than three months, no physical therapy interventions during the last three months were included in the study while patients with bilateral tennis elbow, proximal radio-ulnar joint synovitis, radial nerve entrapment, cervical spine radiculopathy, other diseases like medial epicondylitis, impaired sensibility and paralysis that may affect the outcome measurement and previous injury or surgery in the region of common extensor origin were excluded from this study.

Eligibility Criteria:
Inclusion Criteria:

- Patients with pain in the lateral epicondylar region, increased pain with pressure and resistance to wrist extension, persistence of symptoms for more than three months, no physical therapy interventions during the last three months

Exclusion Criteria:

* patients with bilateral tennis elbow, proximal radio-ulnar joint synovitis, radial nerve entrapment, cervical spine radiculopathy, other diseases like medial epicondylitis, impaired sensibility and paralysis that may affect the outcome measurement and previous injury or surgery in the region of common extensor origin
Electroporation for Cancer Treatment Real World Registry

This registry aims to assess real-world long-term disease outcomes for patients treated using reversible electroporation and a chemotherapeutic or calcium; in particular tumour response rates and recurrence rates. The study also aims to characterise side effects and the occurrence of Adverse Events and their relationship to the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Any patient who has been treated using Calcium Electroporation
* Any patient who has been treated using Electrochemotherapy
* Patients must be mentally capable of understanding the information given
* Patients must give written informed consent.

Exclusion Criteria:

* None
Sevoflurane Versus Propofol on Optic Nerve Sheath Diameter During Anesthesia in Steep Trendelenburg Position

We will prospectively compare change in ONSD during anesthesia with sevoflurane-only versus anesthesia with propofol-only in two groups of patients undergoing urologic and gynecologic surgery in the steep Trendelenburg position. We hypothesize that there will be a significant decrease in the size of ONSD during transition from sevoflurane-only anesthesia to propofol-only anesthesia.

Steep Trendelenburg positioning is required for optimal surgical exposure for certain procedures, including robotic assisted laparoscopic urologic and gynecologic procedures. The position is associated with increased intracranial pressure (ICP) and its complications such as post-operative vision loss (POVL) and post-op delirium \[Lee 2013\]. Therefore, it is essential to measure ICP intra-operatively in order to implement real time management. The gold standard for ICP measurement is an external ventricular drain (EVD). However, it is invasive and not practical for the majority of non-neurosurgical procedures. Trans-ocular ultrasound measurement of Optic nerve sheath diameter (ONSD) is a non-invasive alternative for ICP measurement \[Tayal et al 2007; Nash et al 2016\]. Compared to EVD it is non-invasive, less expensive and efficient. It has been validated as a screening tool for identification of patients with elevated ICP who required treatment in several larger studies \[Nash et al 2016; Blecha et al 2017\]. During these procedures prior pre-cautions to prevent increased ICP focused on fluid restriction/selection. Ultrasound measurement of ONSD has not been routinely employed. Furthermore, consideration has rarely been given to the benefits of total intravenous anesthesia (TIVA) rather than volatile anesthetics for anesthesia maintenance during these procedures. Considering the complications of increased ICP, sonographic measurement could prove to be a practical method to efficiently monitor the ICP surrogate \[Riaz et al 2016; Nash et al 2016; Banerjee et al 2017\]. This study will perform intra-operative sonographic ONSD measurements in order to compare the change in ONSD during transition from inhalational maintenance anesthesia (using sevoflurane) to total intravenous anesthesia (TIVA) using propofol.

While other studies have demonstrated that the use of pneumoperitoneum and steep Trendelenburg positioning can lead to an increase in ICP as determined by use of ONSD (Robba et al. 2016), this study describes the added role of ONSD measurement for guiding the choice of anesthesia maintenance (TIVA vs sevoflurane) during surgery in the steep-Trendelenburg position.

Eligibility Criteria:
Inclusion Criteria:

All patients scheduled to undergo surgery in the steep Trendelenburg position at SUNY Downstate Medical Center.

Exclusion Criteria:

\< 18 years old Pregnancy Pre-existing eye disease Prior ophthalmic surgery Inability to tolerate steep Trendelenburg position Patient refusal
Intranasal Versus Intravenous Dexmedetomidine for Hypotensive Anesthesia in FESS

Intranasal dexmedetomidine provided good pharmacokinetic profile. However, intravenous dexmedetomidine have been used in functional endoscopic sinus surgery for several outcomes, there is lack in studies that had compared the efficacy of intravenous and Intranasal Dexmedetomidine for improving quality of the operative field in functional endoscopic sinus surgery.

Therefore, we established this randomized study to compare intranasal dexmedetomidine with intravenous dexmedetomidine improving quality of the operative field in functional endoscopic sinus surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 21 years of age.
* Both genders.
* American Society of Anesthesiologists (ASA) physical status classification I - III who underwent functional endoscopic sinus surgery.

Exclusion Criteria:

* Patients with a body mass index \> 30 kg/m2
* Existing or recent significant disease.
* Contraindications to the use of dexmedetomidine.
* History or presence of a significant disease.
* Significant cardiovascular disease risk factors.
* Significant coronary artery disease.
* Any known genetic predisposition.
* History of any kind of drug allergy.
* Drug abuse.
* Psychological or other emotional problems.
* Special diet or lifestyle.
* Clinically significant abnormal findings in physical examination, electrocardiographic (ECG) or laboratory screening.
* Known systemic disease requiring the use of anticoagulants.
* Any nasal disorders that may hinder nasal administration of the drugs as repeated nasal bleeding or nasal tumors.
* Patients with a history of previous functional endoscopic sinus surgery.
A Study to Assess the Safety of Mavacamten in Korean Patients With Symptomatic Obstructive Hypertrophic Cardiomyopathy

The purpose of this observational post-marketing surveillance study is to assess the real-world safety of mavacamten for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adult participants in Korea. Participants who will receive at least 1 dose of mavacamten will be enrolled.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants 19 years of age or older
* Participants who receive mavacamten according to the approved product label
* Participants who sign the informed consent form

Exclusion Criteria:

* Participants who are prescribed mavacamten for therapeutic indications not approved in Korea
* Participants for whom mavacamten is contraindicated as clarified in Korean prescribing information approved by the Ministry of Food and Drug Safety
A Study of LY2484595 in Patients With High LDL-C or Low HDL-C

The primary purpose of your participation in this study is to help answer the following research question(s)

* Whether LY2484595 in combination with a statin drug (atorvastatin, simvastatin or rosuvastatin; currently used to treat abnormal fat or cholesterol in blood) improves the blood fat profile more than statins alone.
* Whether LY2484595 alone improves blood fats profile compared to sugar pills.
* Whether LY2484595 interferes with break down or functioning of statins.
* Whether LY2484595 has any side effects that would not support testing it in future studies.

Patients will be stratified according to baseline levels of serum triglycerides (\<150 or greater than or equal to 150 milligram/deciliter (mg/dL), HDL-C (\<45 or greater than or equal to 45 mg/dL for men; \<50 or greater than or equal to 50 mg/dL for women), and region (United States or Europe). After a diet lead-in and prior therapy washout phase, subjects meeting all entry criteria will be randomized to one of 10 double-blind treatment groups for a 12 week treatment phase. After randomization, patients will self-administer the study drugs once a day with a low fat meal as their first meal of the day.

Eligibility Criteria:
Inclusion Criteria:

• Diagnosed with Low High Density Lipoprotein Cholesterol (HDL-C) or hypercholesterolemia, after diet lead-in/washout of lipid therapies

Exclusion Criteria:

* History of coronary heart disease, or hardening of the arteries, or heart does not pump sufficiently well
* Hypertension or high blood pressure that is not under control or your study physician does not consider the electrical activity of heart (Electrocardiogram \[ECG\]) to be compatible with participation in the study
* History of a bad skin rash, a prior rash due to a drug or a history of chronic skin disorder (such as psoriasis or eczema)
* Intolerance to certain lipid modifying drugs (including statins and Cholesteryl Ester Transfer Protein (CETP) inhibitors)
* Not willing to stop taking prescription or over the counter drugs you use to control fats in your blood (like fish oil, niacin or statin) or pills to decrease your weight, including herbs
* Not willing to follow the diet (low-fat) that the study physician will recommend
* Have disease of liver, kidneys, muscles or other organs of body, a serious infection or cancer, or abnormal laboratory tests that study physician does not consider compatible with participation in the study
* Breastfeeding woman or a woman who can still become pregnant, but are not willing to use a valid birth control measure to prevent pregnancies
Prednisone in Chronic Rhinosinusitis Without Nasal Polyps

The purpose of this study is to determine whether prednisone is effective in the treatment of chronic rhinosinusitis without nasal polyps in adult patients.

General Objective:

1. Compare clinical improvement in adult patients with chronic rhinosinusitis without nasal polyps (CRSsNP) through application of SNOT 22 questionnaire and visual analogue scale of symptoms, sniff test, acoustic rhinometry and rhinomanometry and nasal endoscopy using Lund-Kennedy score, after 6 months of follow-up after treatment prednisone or placebo plus standard medical treatment for 21 days.

Specific Objectives:

1. Compare decreased in SNOT-22 questionnaire score and visual analog scale of symptoms after treatment with prednisone or placebo.
2. Compare decreased in nasal endoscopy findings, through application of Lund-Kennedy score, after treatment with prednisone or placebo.
3. Compare improvements in smell after treatment with prednisone or placebo.
4. Determine whether there are differences in nasal permeability measured by rhinomanometry and acoustic rhinometry after treatment with prednisone or placebo.
5. Determine whether there is a difference in the SNOT 22 questionnaire score, visual analogue scale of symptoms, score of smell and Lund-Kennedy score between CRSsNP patients and eosinophilia, and CRSsNP patients with normal eosinophils, receiving prednisone or placebo .
6. Determine if there is a difference in the SNOT 22 questionnaire score, visual analogue scale of symptoms, score of smell and Lund-Kennedy score between CRSsNP patients with elevated total immunoglobulin E and CRSsNP patients with normal total immunoglobulin E, receiving treatment with prednisone or placebo.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CRSsNP as recommended European Position Paper on Rhinosinusitis and Nasal Polyps 2012

Exclusion Criteria:

* Treatment with oral corticosteroids or topical corticosteroids the last 4 weeks.
* Previous surgical treatment for CRSsNP
* History of diabetes mellitus and / or glaucoma and / or decompensated hypertension and / or gastric ulcer.
* Pregnancy.
* History of cystic fibrosis, primary ciliary dyskinesia, immunodeficiency, allergic fungal sinusitis, nasal polyps, nasal tumors, hepatic or renal dysfunction.
* Hypersensitivity to prednisone
The Impact of Clinical Pharmacist in the Identification and Management of Treatment Related Problems in the Surgery Ward

Patients in the surgery ward are at risk of morbidity and mortality from various types of treatment-related problems (TRPs). The primary aim of this study is to assess the impact of the clinical pharmacist in the identification and management of TRPs in the surgery ward.

Patients were randomly assigned to intervention (n=50) and usual care (n=50) arms. The clinical pharmacist assessed the types, frequencies, and clinical significance of TRPs for all recruited patients at baseline. Patients and treating surgeons in the intervention arm received recommendations concerning the identified TRPs, while the usual care arm did not. The number of TRPs was reevaluated at follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Admission for elective, urgent, or emergency surgery
* age 18 years or older
* Expected length of stay of 3 days or more in the general surgical ward or the SICU

Exclusion Criteria:

* Pregnancy, breastfeeding, drug or alcohol abuse, active malignancy, or admission for plastic surgery
Audiological Benefit and Improved Quality of Life With Two Bone Conduction Systems: ADHEAR vs. Bonebridge in Experienced Users

Patients implanted with a Bonebridge will be asked to be part of the study. The study subjects are enrolled into the study according to inclusion criteria.

Patients will be asked to wear an adhesive bone conduction device an adapt to it for 30-60 min. After this time period patients will be asked to use the adhesive device instead of the Bonebridge for 3 weeks. Audiologic Tests and quality of life questionnaires will be assessed at the beginning of the study and at the end of three weeks.

Phase 1 Patients will be fitted with an adhesive bone conduction device and asked to fill out two questionnaires. They will then wear the device for 30-60 minutes and decide if they want to wear the device for the remaining study time of three weeks. Patients who do not have sufficient benefit from the device or do not feel comfortable with it do not enter the second study period of wearing the device for three weeks. Patients will be asked to comment on their experiences after 30 to 60 minutes explaining why they do not want to enter the second part of the study if they feel comfortable sharing this information. Phase 2 Patients, in the second study period, will be asked to wear the hearing device as long as comfortable to them every day and mark time of device usage, battery life, changes of the adhesive adapter, sound quality and comfort related remarks in a diary. After three weeks patients will return to the outpatient ́s department for an audiological assessment and a second set of quality of hearing and quality of life questionnaire.

No patients will be implanted with a Bonebridge as part of the study.

Audiologic testing consists of sound field audiometry, Freiburg monosyllables test and Oldenburg sentence test.

Questionnaires consist of the AQol-8D and the SSQ-12

Eligibility Criteria:
Inclusion Criteria:

* Patients implanted with a Bonebridge device and are active users
* Unilateral and/or bilateral conductive hearing loss (CHL)
* Subjects aged 13 years or older
* Capable of the German language
* Willingness and ability to perform all tests required for the study
* Signed, and dated informed consent before the start of any study specific procedure

Exclusion Criteria:

* Pregnancy or breastfeeding
* Patient is intolerant of the materials as described by Manufacturer's IFU
* Patient presents with a skin or scalp condition that may preclude the attachment of the adhesive adapter.
* Patient cannot perform the audiological tests or is unable to fill out the questionnaires.
* Patient presents with retrocochlear, or central auditory disorder.
* any physical, psychological, or emotional disorder that would interfere with the ability to perform on test and rehabilitation procedures