cyrilzakka/clinical-trials huggingface dataset:
D5611C00003 - Food Interaction Study With AZD1722 Tablet in Healthy Subjects

Study to evaluate the effect of intake of food in comparison to fasting condition on pharmacodynamics of AZD1722 following a twice-daily administration of AZD1722 tablet formulation

A Phase I, Open-label, Randomized, Single-center, 3-way Crossover Study in Healthy Subjects to Evaluate the Pharmacodynamics Effects of AZD1722 Administered With and Without Food (Part A) plus a 2-way Crossover in Subjects to Evaluate the Pharmacodynamic Effect of AZD1722 Administered as an AZD1722 Free-base Tablet with and without Omeprazole (Part B)

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male and female volunteers aged 18 to 65 years
2. Females of childbearing potential had to have a negative pregnancy test and females of childbearing potential included in the study had to use 2 effective methods of avoiding pregnancy, females of nonchildbearing potential to fulfill 1 of the following criteria:

   1. Postmenopausal, defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatment and luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the postmenopausal range
   2. Documentation of irreversible surgical sterilization by hysterectomy, tubal occlusion, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation
3. Had a body mass index (BMI) of 18 and 30 kg/m2, inclusive, and weight at least 50 kg and no more than 100 kg
4. Regular bowel habits of at least 1 stool portion per day.

Exclusion Criteria:

(1) History of clinically-significant disease or disorder (2) History or presence of GI, hepatic, or renal disease, including GI surgery, or any condition known to interfere with absorption, distribution, metabolism, or excretion of drugs. (3) Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks (4) any clinically-significant abnormalities in clinical chemistry, hematology, or urinalysis.

(5) Abnormal vital signs after a 10-minute supine rest, any clinically-significant abnormalities in rhythm, conduction, or morphology of resting ECG (6) Prolonged QTcF greater than 450 ms or shortened QTcF less than 340 ms or family history of long QT syndrome.

(7) Loose stools (Bristol Stool Form Score \[BSFS\] of 6 or 7) 2 or more days during the 7 days prior to randomization (8) Use of medications that are known to affect stool consistency and/or GI motility, including fiber supplements, probiotic supplements, probiotic supplements in medication form, antidiarrheals, prokinetic drugs, enemas, probiotic medications or supplements (ie, Activia®); or salt or electrolyte supplements containing sodium, potassium, chloride, or bicarbonate formulations during the past 7 days before randomization
Accuracy of Various Advanced Treatment Planning Software for Static Computer Guided Surgery in Dental Implant

This study will be conducted to investigate the accuracy of Blue sky plan bio , exoplan ,and real guide advanced treatment planning software required for static computer guided surgery designing and manufacturing.


Eligibility Criteria:
Inclusion Criteria:

1. partially edentulous adults with at least three teeth remaining.
2. an expected sufficient bone volume to perform implant insertion with at least a 3.5mm Cybermed dental implant without simultaneous bone augmentation.
3. extractions performed at least 3 months earlier.
4. potential earlier sinus grafting was performed at least 6 months prior to implant placement.
5. Patients with absence of any periodontal problems in the adjacent teeth.

7- stable medical condition to undergo implant surgery (ASA 1 or 2).

Exclusion Criteria:

1. Physical or psychological disorders generally prohibiting implant therapy. After initial screening.
2. Patients with a history of bruxism
3. Patients with over eruption of the opposing tooth.
Monitoring Sleep, Wellbeing, and Glucose Metabolism in PGY1s

Overnight on-call schedules can impact sleep, wellbeing, and alertness, which can be detrimental on the performance, physical and mental health of residents. Moreover, rotating shift work may have a long-term negative health impact (e.g. increased risk of diabetes). Within the National University Hospital (NUH), two different systems of rotating on-call schedules are implemented. In the night float system, residents work from 8 pm to 8 am for 5 - 7 consecutive nights once every month, compared to the traditional overnight on-call system, where each resident is on call for 4-6 nights per month (7 am - 5 pm, followed by overnight call until 8 am the next morning). The aim of the current study is to track sleep, wellbeing, and glucose metabolism during the different phases of the night float and traditional on-call schedules.

Overnight on-call schedules can impact sleep, wellbeing, and alertness, which can be detrimental on the performance, physical and mental health of residents. Moreover, rotating shift work may have a long-term negative health impact (e.g. increased risk of diabetes). Within the National University Hospital (NUH), two different systems of rotating on-call schedules are implemented. In the night float system, residents work from 8 pm to 8 am for 5 - 7 consecutive nights once every month, compared to the traditional overnight on-call system, where each resident is on call for 4-6 nights per month (7 am - 5 pm, followed by overnight call until 8 am the next morning). The aim of the current study is to track sleep, wellbeing, and glucose metabolism during the different phases of the night float and traditional on-call schedules.

The availability of accurate mobile methodologies to monitor sleep and metabolic health provide new avenues for the improvement of sleep health and well-being. Wearable sleep tracking devices and smartphone apps provide remarkable opportunities for non-invasive, longitudinal sleep detection. Measurement of sleep during different stages of the shift schedule (baseline, on-call, recovery) can provide detailed insights into the temporal impact of the different schedules. Moreover, self-reported ratings of sleep quality, wellbeing, and time-use (delivered through phone-based e-diary methods) can further detail the mental health impact associated with these schedules.

Wearable continuous glucose monitoring systems (CGMS) provide a minimally invasive means of passively tracking ambulant interstitial fluid glucose levels in real time.

Eligibility Criteria:
Inclusion Criteria:

* NUHS Postgraduate year 1 doctors
* Above 21 years of age
* Completing their year 1 rotations in 2021 or 2022

Exclusion Criteria:

* As this is an observational study with minimal risk, in an restricted pool of participants, no further exclusion criteria will be applied for participation.
Pivotal Study of the iNAP® in Adults With OSA

A Prospective, Self-controlled, First-night Order Cross-over and Evaluator-blind Pivotal Study to Evaluate the Efficacy and Safety of iNAP® Sleep Therapy System in Adults with Obstructive Sleep Apnea (OSA)

Obstructive sleep apnea (OSA) impacts sleep quality of patients, which contributes significantly to hypertension, stroke, myocardial infarction and other health problems. Intraoral devices, such as tongue retaining devices, palatal lifting devices and mandibular repositioning devices designed to increase the patency of the airway and to decrease airway obstruction, are used to treat OSA. To this end, the investigators are conducting a prospective, self-controlled, first-night order cross-over and evaluator-blind pivotal study to evaluate the efficacy and safety of iNAP® Sleep Therapy System (iNAP®), a tongue and soft palate retaining intraoral device, in adults with OSA.

Eligibility Criteria:
Inclusion Criteria:

* Patients able to read and sign on the informed consent form and able to comply with study requirements.
* Body mass index (BMI) \<33 kg/m2
* AHI between 15\~55
* Pass a device feasibility test

Exclusion Criteria:

* Obstructed nasal passages
* Hypoxemia (SpO2 \<80%)
* Primary insomnia or other suspected sleep disorder other than OSA
* Muscle diseases, e.g. CSA
* Patients with potential complications of sleep apnea that, in the opinion of the Investigator, may affect the study interpretation or the health or safety of the patients
The Effect of Microneedle Pretreatment on Topical Anesthesia

This study evaluates the role of microneedle pretreatment in the speed at which anesthesia develops after application of topical 4% lidocaine.

This study evaluates whether the time to anesthesia with topical 4% lidocaine can be accelerated with the use of microneedle pretreatment. The study will evaluate the anesthesia as a randomized split-body study where each subject serves as their own control. The study will be performed on the volar forearm. Prior to application of the topical 4% lidocaine, one arm will be exposed to a microneedle pretreatment on a microneedle roller and the other arm will be exposed to sham microneedle treatment that will consist of a flat roller with no microneedles. Then pain will be assessed with the use of a spring loaded needle lancet that will be applied at 2 min, 5 min, 10 min, and 30 minutes after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Allergy to lidocaine
* Smokers
Hemodynamic Analysis for Intracranial Aneurysms Recanalization After Endovascular Treatment

This study was designed to collect a large series of patients with aneurysms treated endovascularly to analyze hemodynamic factors that affect aneurysm recanalization.

With the rapid development of endovascular technique, endovascular treatment has become the first line treatment for intracranial aneurysms (IAs). Compared to microsurgical clipping, less invasive and lower morbidity have been shown after endovascular treatment. However, the aneurysms recanalization is the drawback of such modality. It has been reported that many factors, including complete initial embolization, stent assisted coiling, dense packing and flow diverter, could reduce recanalization rate. Larger size, wide neck, rupture status and intraluminal thrombosis are reported as risk factors of aneurysm recanalization. However, no analysis of hemodynamic risk factors affecting the aneurysm recanalization has been conducted in a large prospective series of patients.

Hemodynamics is reported to play an important role in aneurysm initiation, growth and rupture. Previous studies have showed that the hemodynamics is associated with outcomes of aneurysms after endovascular treatment. High wall shear stress and flow velocity are risk factors of aneurysm recanalization. However, the relationship between hemodynamics and aneurysm outcomes is still unclear. To explore the hemodynamic predictors of aneurysm recanalization is of great value for clinical practice.

Hemodynamic analysis for intracranial aneurysms recanalization after endovascular treatment (HARET) is a prospective trial designed to collect a large series of patients with aneurysms treated endovascularly to analyze hemodynamic factors that affect aneurysm recanalization.

Eligibility Criteria:
Inclusion Criteria:

* Patients treated by endovascular approach for intracranial aneurysm(s)
* Patients older than 18 years
* Patients accepting to participate to the study

Exclusion Criteria:

* Patients already treated by endovascular approach for an intracranial aneurysm
* Patients having a brain arteriovenous malformation
* Patients having a fusiform aneurysm
* Patients having a dissecting aneurysm
* Patients treated by parent vessel occlusion
* Patients treated by covered stent
* Patients lacking 3-dimensional aneurysm images or the images not satisfied the simulation
EarGenie: Assessment of a Minimum Viable Product

The goal of this clinical trial is to evaluate safety and preliminary efficacy of a novel device (EarGenie MVP) to assess hearing function in infants, using a small number of infants with normal hearing. The main questions it aims to answer are:

* Is our device safe?
* Does the device provide preliminary results consistent with previous results from a commercial functional Near Infrared Spectroscopy (fNIRS) research device?

Participants will attend one test session and have their hearing assessed with the EarGenie MVP device.

This is a first-in-human study to evaluate safety and preliminary efficacy of our prototype hearing assessment system (EarGenie MVP). EarGenie MVP uses fNIRS technology to assess an infant's brain response to hearing speech sounds, or discriminating between different speech sounds. It includes software to automatically run analysis in real time, and has a user interface allowing clinicians to operate the tests and receive result reports. The test methods and analysis software have been developed using our commercial fNIRS research system, but the EarGenie MVP has been designed for easy use in paediatric audiology clinics.

10 infants with normal hearing will be recruited for the study, and undergo one test session each with the EarGenie MVP. Safety data will be documented and the results of the tests examined to see if they are consistent with the results expected from our experience using the commercial device in 36 infants with normal hearing.

Eligibility Criteria:
Inclusion Criteria:

* Is between the ages of 1 and 24 months at the time of fNIRS testing.
* Has no known hearing loss
* Has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.

Exclusion Criteria:

* There are no exclusion criteria other than not meeting the inclusion criteria.
Conventional Neck Exercise With and Without Scapular Corrective Exercises in Patients With Forward Head Posture

To determine the effects of conventional neck exercises with and without scapular corrective exercises on pain, cervical range of motion and disability in patients with forward head posture


Eligibility Criteria:
Inclusion Criteria:

* forward head posture
* complain of pain for at least 3months
* no history of any therapeutic interventions for the last 3months

Exclusion Criteria:

* history of whiplash injury
* any cervical surgery
* previous history of significant trauma
* fracture of cervical or scapula
* neurological impairments
* cervicogenic head ache
The Effects of Mulligan Mobilization Technique in Older Adults With Neck Pain

When the literature is examined, there is study investigating the effect of mulligan mobilization technique on older adults with neck pain. This study aims to investigate the effect of mulligan mobilization technique on pain, range of motion, functional level, kinesiophobia, fear of movement, depression and quality of life in older adults with neck pain.

Neck pain is common in older adults. There are a lot of approaches for treatment of neck pain such as soft tıssue mobilizations, electirical stimulations etc. Mulligan proposes mobilization with movement (MWM) technique for various musculoskeletal disorders. But there is no study related MWM for older adults with neck pain. The purpose of this study is to examine the effect of mulligan mobilization technique on pain, range of motion (ROM), functional level, kinesiophobia, depression and quality of life (QoL) in older adults with neck pain. The hypothesis of our study is MWM can be effective on ROM, kinesiophobia, depression and QoL in older adults with neck pain.

Eligibility Criteria:
Inclusion Criteria:

* Ongoing neck pain for at least 3 months,
* Having no neurological, rheumatological or musculoskeletal problems
* Having not taken any analgesic medication for neck pain for the last 3 months.

Exclusion Criteria:

* Neck pain originating from various pathologies
* Presence of cord compression,
* Vertebrobasilar artery insufficiency,
* Severe radiculopathy,
* Osteoporosis or osteopenia (t score\>-1),
* Long-term use of anticoagulant or corticosteroid drugs,
* Patients who had received any treatment for their neck pain.
A Phase 2 Multi-Center Study To Evaluate The Efficacy And Safety Of A Chemokine CCR2/5 Receptor Antagonist In Adults With Type 2 Diabetes And Overt Nephropathy

The study hypothesis under test is that administration of a CCR2/5 antagonist to subjects with type 2 diabetes and overt nephropathy will result in a reduction in urinary albumin, a surrogate for improved glomerular filtration.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 2 diabetes together with stages 2, 3a, 3b or 4 CKD, based on an eGFR of 20-75 mL/min/1.73m2.
* Evidence of persistent, overt albuminuria; defined as a UACR \>=300 mg/g (\>=33.9 mg/mmol) or UPCR \>=390 mg/g (44.1 mg/mmol), or equivalent, for 3 months or longer.
* Stable background therapy of RAAS inhibition (ie, an ACE inhibitor and/or an ARB, which may also include an aldosterone antagonist in double RAAS but not triple RAAS inhibitor therapy) for at least 3 months before screening and to be maintained for the duration of the study.

Exclusion Criteria:

* Subjects with CKD resulting from type 1 diabetes or non-diabetic CKD.
* Subjects who are diagnosed with autosomal dominant polycystic kidney disease (ADPCKD), severe peripheral vascular disease (PVD) or obstructive uropathy.
Combination Chemotherapy Plus Bevacizumab in Treating Patients With Advanced Colorectal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Bevacizumab may stop the growth of colorectal cancer by stopping blood flow to the tumor.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus bevacizumab in treating patients who have advanced colorectal cancer.

OBJECTIVES: I. Determine the progression-free survival at 7 months of patients with previously untreated advanced colorectal cancer treated with fluorouracil, leucovorin calcium, irinotecan, and bevacizumab. II. Determine the response rate and overall survival of this patient population treated with this regimen. III. Determine the toxicity of this treatment regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV once weekly for 4 weeks. Patients also receive bevacizumab IV over 30-90 minutes once every 2 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed advanced or metastatic adenocarcinoma of the colon and rectum Surgically unresectable disease Measurable disease Disease outside the prior radiotherapy port and/or progressive disease within the previously irradiated volume

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 No hemorrhagic events within the past 6 months Hepatic: Bilirubin normal SGOT normal INR no greater than 1.5 Renal: Creatinine no greater than 1.5 times upper limit of normal Cardiovascular: No thromboembolic events within the past 6 months Pulmonary: No evidence of pneumonia Other: No known hypersensitivity to recombinant humanized murine monoclonal antibodies No evidence of significant active infection (e.g., peritonitis or wound abscess) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent sargramostim (GM-CSF) Chemotherapy: At least 12 months since prior fluorouracil-based adjuvant chemotherapy No prior adjuvant irinotecan Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 2 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics Other: No prior therapy for advanced disease No concurrent therapeutic anticoagulation except for low-dose coumadin for maintenance of indwelling catheters
Efficacy of Conservative Treatments for Urinary Incontinence in Women

To conduct a retrospective study to examine the effect of these conservative treatments to the symptoms and quality of life of patients with urinary incontinence. The investigators will use both subjective and objective assessment parameters, such as self-report symptoms, bladder diary, pad test and urodynamic study to access the improvement.

Urinary incontinence is a common problem among women. The main types include stress incontinence, urge incontinence, and overflow incontinence. Other underlying pathology, such as cancer or neurologic disease can also cause urinary incontinence. To limit the medical expenses and possible complications of surgical treatment, the current treatment guidelines recommend conservative treatment as the first choice. According to American Urological Association (AUA)/Society of Urodynamics, Female Pelvic Medicine \& Urogenital Reconstruction (SUFU) guidelines, the first-line treatment for non-neurologic overactive bladder should be behavioral therapy, such as bladder training, water restriction, and pelvic floor muscle training, physiological feedback, pessary, etc. Bladder training aims to increase the time interval between voids, and to increase the bladder capacity by self-adjusted schedules. Pelvic floor muscle training strengthens the pelvic floor muscles to provide urethral support to prevent urine leakage and suppress urgency. There is strong evidence that pelvic floor muscle training is beneficial for stress urinary incontinence.

The second-line treatment is medication, including anticholinergic drugs and ß3 adrenoceptor-acting agents. Anticholinergic drugs can reduce bladder detrusor contraction, and ß3 adrenoceptor-acting agents can relax the detrusor and increase bladder capacity.

Eligibility Criteria:
Inclusion Criteria:

* Adult female patient diagnosed with urinary incontinence through clinical assessment
* Diagnosed at Mackay Memorial Hospital and underwent non-surgical treatment and subsequent follow-up.

Exclusion Criteria:

* Choosing invasive or surgical treatment options (such as bladder botulinum toxin injection, urethral sling surgery).
* Unable to comply with regular follow-up for at least one year.
* Pregnant women
* Patients with a history of neuromuscular disorders.
Immunotherapy of Hepatocellular Carcinoma by Induction of Anti-alpha Fetoprotein Response

The secretion by tumor cells of alpha fetoprotein (AFP) was observed in 50 to 60% of hepatocellular carcinoma. The AFP can be used as a marker for tumor recurrence after treatment and may be considered as a tumor antigen specific for hepatocellular carcinoma.The aim of the project is to use the alpha fetoprotein (AFP) as a tumor antigen and to propose an approach of immunotherapy for hepatocellular carcinoma based on the injection of autologous dendritic cells loaded with specific peptides of AFP.


Eligibility Criteria:
Pre-inclusion Criteria :

* Adults (men or women) aged between 18 and 80 years
* Patients affiliated to a social security reimbursement system
* Signed informed consent
* Hepatocellular carcinoma
* At least one dosage with Alpha-foeto-protein ≥ 40 ng/ml
* Patient already treated with chemoembolization, percutaneous destruction (alcohol or radiofrequency), surgery or Sorafenib.

Inclusion Criteria:

* Negative test for pregnancy or effective contraception
* Patient HIV-, Hep B-, Hep C-, HTLV1 and 2-, Syphilis-
* HLA A 0201 group

Exclusion Criteria:

* Life expectancy \< 3 months
* Pregnancy or breast-feeding
* Severe auto-immune disease
* Another malignant tumor except if considered as cured since more than 5 years
* History of uncontrolled psychiatric condition
* Risk factors of Creutzfeldt Jacobs disease
* Decompensated cirrhosis(ascites or Child-Pugh score greater than 8)
* Hepatic transplantation