cyrilzakka/clinical-trials huggingface dataset:
A Smart Sleep Apnea Self-management Support Programme(4S) for Subjects With Sleep Apnea

OSA is a chronic disease with high prevalence that parallels with increasing obesity. Self-management programmes are perceived to be cost-effective in long-term OSA patient care and can supplement regular medical treatments. The current study attempt to examine the effectiveness of 4S on improving apnea severity, cardiovascular health and quality of life in 4S intervention (4S) group, compared to the general hygiene (GH) control group.

OSA is a chronic disease with high prevalence that parallels with increasing obesity. OSA affects around 12% and 24% of adults in Hong Kong and China Mainland, respectively. Chronic intermittent hypoxia and sleep fragmentation of OSA leads to cardiometabolic and neurocognitive sequelae (e.g. hypertension, diabetes, daytime sleepiness and depression). Long-term, multidisciplinary management involving patients in decision-making of treatment strategies, shifting from positive airway pressure (PAP) device-focused to the patient-centered chronic care model has been suggested.

Mobile instant messaging (such as WhatsApp/WeChat) are popular and inexpensive for interactive messaging. Smartphone-based self-management interventions were reported improved self-efficacy and clinical outcomes in patients with chronic diseases. The investigator only found one mobile health application to support CPAP therapy for OSA and one ongoing trial of OSA self-management telematic support to improve CPAP adherence. There is underutilization of mobile technology in patient-centered self-management programmes to improve PAP treatment and lifestyle modifications in OSA.

The current study attempt to examine the effectiveness of 4S on improving apnea severity, cardiovascular health and quality of life in 4S intervention (4S) group, compared to the general hygiene (GH) control group. Questionnaire and simple fitness assessment will be used to assess the effectivness of the intervention at 4-month and 12-month follow-up. Focus group interview will be conducted to collect qualiatative feedback on the intervention.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 years and above;
* diagnosis of moderate to severe obstructive sleep apnea (AHI≥15);
* physically inactive (self-reported moderate physical activity per week of \<150 minutes);
* overweight (BMI≥23 kg/m2);
* mentally, cognitively and physically fit to join the trial as determined by the doctor in-charge and responsible clinical investigators;
* able to speak and read Chinese;
* willing to complete the questionnaires and assessments;
* has a smartphone with instant messaging function (eg. WhatsApp/WeChat); and
* willing to give informed consent.

Exclusion Criteria:

* sleep disorder other than OSA;
* clinically significant psychiatric, neurological, or medical disorder other than OSA; and
* use of prescription drugs or clinically significant drugs affecting sleep.
Angiotensin-II Receptor Antibodies Blockade With Losartan in Patients With Lupus Nephritis

Antibodies directed against angiotensin-II receptor (AT1-Ab) are agonist antibodies previously studied in human diseases such as preeclampsia, transplantation and scleroderma. They act by binding to the AT1 receptor and their effects can be blocked with the use of angiotensin receptor blockers (ARB). In this randomized open clinical trial the investigators will study the effect of the blockade of AT1-Ab with losartan in carotid intima-media thickness progression in patients with lupus nephritis compared to patients treated with enalapril.

Angiotensin-II type 1 receptor antibodies (AT1R-Ab) are agonist antibodies directed against the second loop of the AT1 receptor. These antibodies have been studied in human diseases such as preeclampsia, transplantation and scleroderma. A previous study from the investigators' group found an elevated prevalence of AT1R-Ab in patients with lupus nephritis. As these antibodies have been linked to atherosclerosis development this open randomized clinical trial was designed to evaluate the effect of AT1R-Ab blockade with losartan compared to the use of enalapril in the progression of carotid intima-media thickness (CIMT) in patients with active lupus nephritis.

Biopsy-proven lupus nephritis patients who tested positive for AT1R-Ab will be performed a CIMT measurement by Doppler ultrasound at the time of the biopsy and then at 12-months follow up.

The primary outcome will be the change in the CIMT in the course of 12 months in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Signed consent form for the study
* Biopsy-proven lupus nephritis with proteinuria \> 1.5g/g by 24 hour urine protein to creatinine ratio
* Need for immunosuppressive induction to remission therapy according to the treatment physician
* Systemic lupus erythematosus diagnosis based on at least 4 American College of Rheumatology criteria
* Age between 16 and 50 years

Exclusion Criteria:

* Patient does not want to participate in the study
* Comorbid disease such as diabetes mellitus with macro/microangiopathy, previous diagnosis of hypertension \>5 years, scleroderma
* Comorbid findings in the histopathological analysis of the renal biopsy
The Protective Effect of Ginkgo Biloba Extract on Cisplatin-induced Ototoxicity in Humans

The proposal of this study was to evaluate in human beings, using distortion product otoacoustic emission (DPOAE) test, the action of ginkgo biloba extract (GBE761)as a possible ear protective against cisplatin (CDDP) induced hearing loss.

The ototoxicity is an alteration caused by drugs that compromises the auditory and vestibular functions. The cisplatin (CDDP) is a potent antineoplastic agent used for the treatment of cancer in both adults and children although it has several side effects. Current opinion is that cisplatin ototoxicity occurs due to alterations in the antioxidant system of the outer hair cells (OHC) of the cochlea. The distortion-product otoacoustic emissions (DPOAE) has been showed to be a sensitive test for diagnosis of OHC injury and has been used for monitoring treatment with ototoxic drugs. Because of their antioxidant properties, the ginkgo biloba extract (GBE761) was evaluated in human beings as a possible ear protective against cisplatin induced hearing loss, using DPOAE test.

Eligibility Criteria:
Inclusion Criteria:

* Over the age of eighteen
* Patients that will begin treatment with cisplatin
* No prior treatment with cisplatin

Exclusion Criteria:

* Individuals with middle ear, cochlear or retrocochlear disease
* Presence of changes in pure tone audiometry and/or distortion-product otoacoustic emissions
EUS-PPG vs HVPG in Portal Hypertension

The objective of this study is to evaluate the correlation of the calculated portal pressure gradient (PPG) obtained by direct portal and hepatic pressure measurements with a conventional 22 G needle guided by EUS and indirect portal vein pressure measurements using the interventional radiology based hepatic venous pressure gradient (HVPG) procedure.


Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* Undergoing evaluation for chronic liver disease or portal hypertension
* Signed informed consent

Exclusion Criteria:

* Uncorrectable coagulopathy (INR above 1.5)
* Uncorrectable thrombocytopenia (Platelets under 50,000)
* Anticoagulation or antiplatelet therapy that cannot be discontinued
* Biliary obstruction
* Grade II ascites or more
* Intrahepatic portal vein thrombosis
* Pregnancy
Comparative Study of Efficacy of 10 mg Dequalinium Chloride (Fluomizin) in the Local Treatment of Bacterial Vaginosis

The purpose of this clinical study was to evaluate whether vaginal tablets containing 10 mg dequalinium chloride (Fluomizin) are comparable in clinical efficacy and safety to clindamycin vaginal cream (2%) in patients suffering from bacterial vaginosis.

An international, multi-center, single-blind, randomized, active-controlled study with two parallel groups in patients with bacterial vaginosis. Eligible patients were randomized to receive Fluomizin vaginal tablets for 6 days or Clindamycin vaginal cream (2%) for 7 days. Control examinations were performed 3 to 14 days and 2 to 6 weeks after the end of the therapy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of bacterial vaginosis
* Women aged 18-55 years

Exclusion Criteria:

* Pregnancy or lactation
* Uterine bleeding (including menstruation but not including cervical contact bleeding on sampling) or vaginal bleeding of unknown origin
* Acute infections of the upper genital tract
* Clinical Symptoms of a vulvovaginal Candidiasis
* Use of anti-infectives (local or systemic) in the previous 14 days and/or during the study
The Effect of Head-Neck Stretching Exercises After Thyroidectomy on Postoperative Pain Level and Wound Healing

Background: Thyroid diseases are one of the most common health problems all over the world. After thyroidectomy, patients often experience discomfort such as neck pain, shoulder stiffness, shoulder movement difficulty, choking or pressing feeling. Head-neck stretching exercises provide neuromuscular coordination and flexibility in patients by reducing pain and muscle weakness.

Methods: This research was carried out as a pre-test / post-test control group experimental design study in 82 patients in the general surgery clinic of a university hospital in Istanbul

Thyroid hormones are responsible for many metabolic activities in human physiology. It increases the basal metabolic rate, affects protein synthesis and helps growth of long bones. However, when thyroid functions change in the human body, the individual can be negatively affected and some individuals may require surgical intervention. Thyroid surgery is a prominent treatment for goiter, hyperthyroidism, thyroid nodules or thyroid carcinoma.

It has been reported that the most important complications after thyroidectomy are laryngeal nerve damage and hypoparathyroidism. Therefore, patients generally suffer from uncomfortable symptoms such as neck pain, shoulder stiffness, difficulty moving shoulders, choking or pressing feeling. In addition, it is indicated that in the early postoperative period, patients experience limitation in neck movement and have a robotic walking style in order to prevent possible neck pain and protect the incision area. It is emphasized that these symptoms persist for a while after the operation and negatively affect the daily life of the patient.

Neck stretching exercises which include basic movements of the neck are simple and effective exercises. Stretching exercises provide neuromuscular coordination and flexibility in patients by reducing pain and muscle weakness. For this reason, neck stretching exercises should be performed in early postoperative period and a nurse should teach the patient the head-neck stretching exercises and ensure the patient's comfort after thyroidectomy.

Eligibility Criteria:
Inclusion Criteria:

* Having agreed to participate in the research verbally and in writing after being informed about the research,
* 18 years of age or older,
* Patients who were able to understand the information given, who could read, write and speak in Turkish, who have not any problems preventing verbal communication, and who underwent thyroid surgery were included in the study.

Exclusion Criteria:

- Patients who suffers from cervical problems before surgery were excluded from the study.
Nivolumab and Ipilimumab in Classical Kaposi Sarcoma (CKS)

A Phase 2 study of nivolumab plus ipilimumab in previously treated classical Kaposi Sarcoma (CKS)

A prospective, single arm, interventional study. All patients will receive IV nivolumab 3mg/kg every two weeks and ipilimumab 1mg/kg every 6 weeks. Patients will be treated until disease progression or intolerable toxicity for a maximal period of two years, with an option to re-initiate therapy upon progression in patients with prior documented response to investigational therapy (unless treatment was held for progression of disease).

Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed KS
* Age \> 18
* ECOG PS \< 2
* At least one prior treatment modality (palliative radiation or chemotherapy)
* Measurable disease as defined by RECIST version 1.1 by physical exam and/or PET-CT (previously irradiated lesions should not be counted as target lesions).

Exclusion Criteria:

* Patients with HIV-related KS or HIV positive serology.
* Ongoing immunosuppressive therapy
* Active autoimmune disease. Subjects with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
Effect of Alfacalcidol to Respiratory Infection and Immune Response of Indonesian Elderly

Vitamin D has been known to influence immune response through Vitamin D Receptor in Immune Cells, but only few has been known about the effect alfacalcidol, a vitamin D analog to immune system. In elderly, immune disregulation or immunosenecence have great impact to infection response. This study is aimed to determine the effect of alfacalcidol supplementation in vitro and in vivo to respiratory infection incidence and inflammatory markers, as well as T cell lymphocyte subset in Indonesian elderly patients.

This study consist of 2 designs. First is in vitro study to investigate the effect of alfacalcidol supplementation to IL-6, IL-10 and IFN gamma regulation in Peripheral Blood Mononuclear Cells (PBMC) of elderly and second design is randomised controlled trial to evaluate the effect of 3 months supplementation of alfacalcidol 0,5 mcg in respiratory infection, antibiotic use, inflammatory markers, CD4/CD8 ratio and CD8+ CD28+ in Indonesian elderly with various level of frailty syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Elderly age more than 60
* Willing to join research

Exclusion Criteria:

* In acute infection
* Using NSAID or steroid
* Liver failure
* Hypercalcemia
Effect of Buccal Fat Pad Derived Stem Cells in Maxillary Sinus Augmentation

In this study the buccal fat pad derived stem cells (BFPSCs) will be harvested from buccal fat pad tissue of patients receiving maxillary sinus augmentation. In the test group the patients receive a combination of platelet rich fibrin (PRF) and freeze dried bone allograft (FDBA) (SureOss, Hansbiomed, Korea) loaded with BFPSCs. The results will be evaluated by cone beam computed tomography (CBCT)and hematoxylin and eosin staining in 6 months.

The buccal fat pad derived stem cells (BFPSCs) is harvested from buccal fat pad tissues. The BFPSCs will be loaded on freeze dried bone allograft (FDBA) (SureOss, Hansbiomed, Korea). Furthermore, twenty milliliters of the venous blood is obtained, placed and collected in a sterile tube, and centrifuged (GAC medical) for 14 minutes at 2800 rpm (approximately 400 g). Following centrifugation, three layers are separated in the tube: cellular plasma at the top, platelet rich fibrin (PRF) clot in the middle and red blood cells at the bottom of the tube. The PRF clot is separated by a sterile pincette.

The patients in the test group receives BFPSCs loaded on DFDBA with PRF for sinus augmentation and the control group receives combination of PRF and DFDBA (lacking any cells).The results will be evaluated by cone beam computed tomography (CBCT) in 6 months and microscopic evaluation of the biopsies by hematoxylin and eosine staining.

Eligibility Criteria:
Inclusion Criteria:

1. patients with posterior maxillary edentulism
2. pneumatized sinus
3. less than 5mm bone height between the alveolar crest and sinus membrane

Exclusion Criteria:

1. smoking
2. history of malignancy
3. radiation
4. chemotherapy
5. pregnancy
6. systemic diseases contradicting dental and surgical treatments
7. conditions or drugs affecting bone remodeling or bone metabolism and connective tissue
8. allergy to collagen
Establishing Ambulatory Glucose Profiles for People Without Diabetes Using CGM Data

In a previous study we used the FreeStyle Navigator Continuous Glucose Monitoring (CGM) System to obtain 30 days of glucose measurements from 30 people with diabetes treated with insulin. The purpose of this study is to characterize glycemia (glucose) control in 30 people without diabetes and to compare these data to the 30 people with diabetes from a previous study. Through this approach it may be possible to develop a means of establishing a model of normal glucose patterns and a basis of comparison with glucose patterns in people with diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Within normal range for two hour OGTT glucose level (\<140 mg/dl)
* Within normal range for fasting glucose level (\<100 mg/dl)
* Within normal range for total insulin level as measured by radioimmunoassay
* BMI \<30kg/m2
* Age 21-75 years of age, inclusive (15 subjects in the 21-49 years of age group, 15 subjects in the 50-75 years of age group)
* Willing to give informed consent
* Capable of following the protocol and instructions of study staff
* Available for scheduled visits
* Access to telephone communications

Exclusion Criteria:

* Under 21 years of age or over 75 years of age
* Abnormal OGTT
* Previous history of diabetes
* Outside of normal insulin range
* BMI \> 30kg/m2
* Unable to follow protocol
* Unable to read and write in English
* Skin abnormalities at insertion sites
* Allergy to adhesives
* Any concomitant medical condition that would likely affect the evaluation of device performance
* Taken prednisone or cortisone medications in the previous 30 days
* Blood transfusion within the past 90 days
* Blood donation within the past 30 days
* Metabolic syndrome (NCEP ATP III guidelines)
* Any medical condition that would affect glucose (per investigator decision)
Telemedicine-Delivered Unified Protocol for Cognitive Behavioral Therapy for Anxiety and Depression

This project will evaluate a telemedicine-delivered, Unified Protocol for Cognitive-Behavioral Therapy (UP-CBT) enhanced with continuous glucose monitor (CGM) review to target anxiety and depressive symptoms and glycemic control in adults with type 1 diabetes.

The efficacy of the Unified Protocol for Cognitive Behavioral Therapy (UP-CBT) combined with commercial FDA-approved Continuous Glucose Monitoring (CGM) will be tested in comparison to CGM only in a randomized controlled clinical trial. The central hypothesis is that the addition of the UP-CBT intervention will yield clinically significant improvements in anxiety and depressive symptom severity and glycemic control relative to CGM alone. We will recruit 94 adults (age 18-64) with suboptimally controlled type 1 diabetes and an anxiety or depressive disorder from a national population for an entirely virtual 12-month study over five years, with targeted recruitment of racial/ethnic minorities. In addition to standard measurement of hemoglobin A1c (HbA1c) for glycemic control and validated patient-reported outcome (PRO) surveys, the study integrates momentary psychological and behavioral data via smartphone-based ecological momentary assessment (EMA) with CGM data to assess day-to-day changes in affect, self-management, and glycemia over the course of the trial.

Qualitative information will be collected from people with Type 1 Diabetes (T1D) ages 35-64 to solicit suggestions and inform future study decisions. We will create 2-4 focus groups to ask their impressions about our current study and to explore key factors like establishing adult care and attending medical appointments, disease self-management, and adjusting to chronic disease. We will compare interview responses from participant groups who have high vs. low social needs and poor vs. good glycemic control.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes (T1D) duration ≥ 6 months
* 18-64 years old
* HbA1c = 7.5-14%
* English- or Spanish-speaking
* Anxiety or depressive mood disorder as per structured diagnostic interview.

Exclusion Criteria:

* Developmental or sensory disability interfering with participation
* Current pregnancy
* Bipolar disorders, psychotic disorders, severe eating disorders, severe substance abuse disorders, or acute suicidal risk or self-harm
* Use of medications or recent medical procedures that would impact glycemic control or use of continuous glucose monitoring (CGM) over the study
* Received cognitive behavioral therapy (CBT) in last year or plans to initiate CBT; (6) temporary exclusion for recent initiation of psychotropic medication - must be on a stable dose for 6 weeks prior to enrollment.
Study to Evaluate Safety & Tolerability of BMS-906024 in Combination With Chemotherapy & to Define DLTs & MTD of BMS-906024 in Combination With One of the Following Chemotherapy Regimens; Weekly Paclitaxel, 5FU+Irinotecan or Carboplatin+Paclitaxel in Subjects With Advanced / Metastatic Solid Tumors

The purpose of this study is to identify a safe and tolerable dose of BMS-906024 in combination with each of the following three chemotherapy regimens: Paclitaxel, 5FU plus Irinotecan (FOLFIRI), or Carboplatin plus Paclitaxel in subjects with advanced or metastatic solid tumors

DLTs = dose-limiting toxicities

MTD = Maximum tolerated dose

Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.

Inclusion Criteria:

* Subjects with advanced or metastatic solid tumors for whom a chemotherapy regimen is considered appropriate
* Subjects with non-small cell lung cancer and triple-negative breast cancer are preferred
* Biopsy accessible tumor (may use archived tumor samples under certain circumstances)
* Life expectancy of at least 3 months
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
* Measurable disease

Exclusion Criteria:

* Uncontrolled brain metastases
* Infection
* Gastrointestinal (GI) disease with increased risk of diarrhea (e.g. inflammatory bowel disease)
* Uncontrolled or significant cardiovascular disease
* Subjects taking medications known to increase risk of Torsades de Pointes
I-ZIP Ocular Bandage Pivotal Study

To evaluate the safety and performance of the I-ZIP Ocular Bandage in subjects undergoing uneventful unilateral clear corneal phacoemulsification with foldable monofocal intraocular lens (IOL) implantation compared with the Oasis 24-hour Soft Shield Collagen Corneal Shield (Oasis Medical, Inc. Glendora, California) for providing ocular protection and relief of pain or discomfort in the acute post-operative period.


Eligibility Criteria:
Inclusion Criteria:

* Subject has a cataract and is expected to undergo unilateral clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber monofocal intraocular lens through an incision ≤ 3.5mm in width measured after IOL implantation using internal calipers.

Exclusion Criteria:

* Any intraocular inflammation in the study eye that was present during the screening slit-lamp examination or presence of ocular pain in the operative eye as rated on the pre-operative NRPS
* Previous surgery (laser or incisional) or ocular trauma to the operative eye or planned multiple procedures during cataract/IOL implantation surgery
* Potential BCVA in fellow eye worse than 20/40 as assessed by the clinical Investigator
* Active or history of chronic or recurrent inflammatory eye disease (iritis, scleritis, uveitis, iridocyclitis, rubeosis iritis), evidence of acute external ocular infections, intraocular infection, dysthyroid ophthalmopathy, nasolacrimal duct obstruction, active chalazion, uncontrolled blepharitis, uncontrolled and clinically significant dry eye syndrome, anything more than trace guttata (\>10 guttae in the central 6 mm of cornea), evidence of glaucoma/glaucoma suspect, corneal dystrophy or other ocular disease that would interfere with study evaluations
* Subject is currently receiving antineoplastic therapy
* Use of topical ocular steroids within 14 days and/or systemic steroids (excluding inhalants) within 30 days prior to surgery.
* Subject is an insulin-dependent diabetic or has background diabetic retinopathy (BDR), proliferative diabetic retinopathy (PDR) or compromised macular function