cyrilzakka/clinical-trials huggingface dataset:
Randomized, Double-blind Study to Evaluate the Tolerability of 2 Different Titration Methods of Rivastigmine Patch in AD Patients (MMSE 10-20)

To evaluate the tolerability, safety and efficacy of 3-step titration versus 1-step titration of Rivastigmine patch in the Japanese population.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of dementia of the Alzheimer's type according to the DSM-IV criteria
* A clinical diagnosis of probable AD according to NINCDS/ADRDA criteria
* An MMSE score of ≥ 10 and ≤ 20 at baseline

Exclusion Criteria:

* Any medical or neurological conditions other than AD that could explain the patient's dementia
* A current diagnosis of probable or possible vascular dementia
* A score of \> 5 on the Modified Hachinski Ischemic Scale (MHIS)
* A current DSM-IV Axis 1 diagnosis that may interfere with the evaluation of the patient's response to study medication.
* Treated with donepezil or galantamine within last 4 weeks before the efficacy assessment at baseline.
* an advanced severe progressive or unstable disease of any type that may interfere with efficacy and safety assessments or put the patient's at special risk
* Other protocol-defined inclusion/exclusion criteria may apply.
Safety and Efficacy of Remote Ischemic Conditioning Treatment for Community-based Essential Hypertension

The purpose of this study is to explore the efficacy and safety of remote ischemic conditioning for essential hypertension in the community population.

At present, stroke has become the leading cause of death in China, with hypertension being the primary risk factor and one of the controllable risk factors. Current studies have shown that remote ischemic conditioning can improve vascular endothelial function, inhibit sympathetic nervous system activity and regulate immune and inflammatory reactions. Thus it may exert anti-hypertensive effects through multiple mechanisms. The purpose of this study is to investigate the efficacy and safety of remote ischemic conditioning for essential hypertension in the community population.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥40 years, ≤ 75 years, regardless of sex;
2. Having the history of essential hypertension and the systolic blood pressure of at least 140 mm Hg on two consective days;
3. Signed and dated informed consent is obtained

Exclusion Criteria:

1. Blood pressure ≥ 180/110mmHg;
2. Planned adjustment of antihypertensive drugs in the next month;
3. Severe hematologic disorders or significant coagulation abnormalities;
4. Individuals who had contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury in the upper limb, acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc;
5. Pregnant or lactating women;
6. Severe hepatic and renal dysfunction, or ALT/AST \>3 times upper limit of normal, or serum creatinine \>265umol/l (\>3mg/dl);
7. Patients being enrolled or having been enrolled in another clinical trial within the 3 months prior to this clinical trial;
8. Patients unsuitable for enrollment in the clinical trial according to the investigator's discretion.
MESA Rail™ AIS Study - Preservation of Curve Correction

To evaluate the restoration and maintenance of thoracic kyphosis and coronal curve correction demonstrated through the surgical implantation of the K2M MESA Rail™ Deformity System as compared to literature reported outcomes for standard Cobalt Chrome (CoCr) rod systems in the treatment of Adolescent Idiopathic Scoliosis (AIS).

Patients treated with the Ø5.5mm or Ø4.5mm MESA Rail™ Deformity System that had:

Diagnosis of AIS requiring surgical treatment for selective non-cervical fusion with a minimum of five (5) instrumented vertebrae between T1-S1 as confirmed by patient history and radiographic studies.

AIS cases must be classified as a Lenke type 1 or type 2 curve (lumbar modifiers and thoracic sagittal profiles will be noted but not restrictive).

Age at time of surgery of ≥ 11 years old and ≤ 21 years old.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AIS requiring surgical treatment for selective thoracic/lumbar fusion with a minimum of five (5) instrumented vertebrae between T1-S1 as confirmed by patient history and radiographic studies. AIS cases must be classified as a Lenke type 1 or type 2 curve. No cervical vertebrae are to be incorporated into the construct.
* Willingness and ability to comply with the requirements of the protocol including follow-up requirements.
* Willing and able to sign a study specific informed consent form or, in the case of a patient who is a minor, provide assent and the minor patient's parent/legal guardian provides written consent to participate.
* Age range of ≥ 11 years old and ≤ 21 years old at time of surgery.

Exclusion Criteria:

* Previous anterior or posterior spine surgery at the index levels.
* Previous posterior spine surgery (e.g., posterior element decompression) that destabilizes the cervical/thoracic/lumbar spine.
* Active systemic infection or infection at the operative site.
* Co-morbid medical conditions of the spine or upper/lower extremities that may affect the thoracic or lumbar spine neurological and/or pain assessment.
* Metabolic bone disease such as osteoporosis that contradicts spinal surgery.
* History of an osteoporotic fracture.
* History of an endocrine or metabolic disorder (e.g., Paget's disease) known to affect bone and mineral metabolism.
* Taking medications that may interfere with bony/soft tissue healing including chronic steroid use.
* Known allergy to titanium or cobalt chrome.
* Rheumatoid arthritis or other autoimmune disease or a systemic disorder such as HIV, active hepatitis B or C or fibromyalgia.
* Insulin-dependent type 1 or type 2 diabetes.
* Medical condition (e.g., unstable cardiac disease, cancer) that may result in patient death or have an effect on outcomes prior to study completion.
* Pregnant, or intend to become pregnant, during the course of the study.
* Severe obesity (Body Mass Index \> 40).
Comparison of General Characteristics of Patients Diagnosed COVID-19 (Coronavirus )Positive Followed In Service

comparison of general characteristics of patients diagnosed COVID-19 positive followed In service

After the explanation about the study is made, informed consent form will be obtained from the pregnant women who were hospitalized in the pandemic gynecology service (D block 10th floor pandemic obstetrics service) due to COVID-19 and who agreed to participate in the study. In our study, the clinical status of pregnant patients with COVID-19 positive test results, who were followed up and treated in the pandemic service in Basaksehir City Hospital, will be obtained by asking the patient about the symptoms and vaccination status in the patient follow-up form prepared in advance. Laboratory findings and imaging results ( CT/ anteroposterior X-ray) will be obtained from the recorded data.

Eligibility Criteria:
Inclusion Criteria: Pregnant patients positive COVID-19 test results followed up and treated in the pandemic service of Çam and Sakura City Hospital.

Exclusion Criteria: no exclusion criteria

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A Study to Evaluate ITCA 650 for the Treatment of Type 2 Diabetes in Patients With High Baseline HbA1c

An 39-week plus extensions, open-label study to estimate the reduction in HbA1c in patients with initial HbA1c \>10% \</=12% who are treated with ITCA 650 20 mcg/day for 13 weeks followed by ITCA 650 60 mcg/day for 26 weeks plus optional 26-week extensions with continued treatment with ITCA 650 60 mcg/day


Eligibility Criteria:
Inclusion Criteria:

* Men or women age 18 to 80 years with type 2 diabetes
* On stable treatment regimen of diet and exercise alone or in combination with a stable \& optimal or near-optimal dose of metformin, sulfonylurea, TZD or combination of these drugs
* HbA1c \>10.0% and ≤12.0%

Exclusion Criteria:

* Prior treatment with any GLP-1 receptor agonist
* History of hypersensitivity to exenatide or liraglutide
* FPG \>300 mg/dL
* History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2
* Taking DPP-4 inhibitors, incretin mimetics, alpha glucosidase inhibitors, meglitinides or insulin within last 3 months
* history of pancreatitis
Physical Activity Pathway for Patients With Osteoarthritis in Primary Care (OA-PCP)

This is a multi-phase study that will develop and test an osteoarthritis (OA) primary care Physical activity Care Pathway (OA-PCP), a scalable intervention that includes: 1) a practical process for physical inactivity screening in primary care, 2) a brief, tailored physical activity (PA) counseling intervention via telephone, 3) connection of patients with community programs and other resources to support PA, and 4) follow-up with patients to deliver additional appropriate counseling and referrals to PA resources.

This study will be a single group pilot trial of the OA-PCP. The feasibility and acceptability of the OA-PCP will be assessed among n=60 patients with hip and knee OA in two primary care clinics. All patients in the trial will participate in the OA-PCP and will complete assessments at baseline and 4-month follow-up. Feasibility metrics will include rates of recruitment, intervention engagement and retention; acceptability will be assessed from both patients and health care providers.

Eligibility Criteria:
Inclusion Criteria:

* Physician diagnosis of knee or hip OA
* Current Joint Symptoms
* Current Weekly Physical Activity \<150 minutes per week.

Exclusion Criteria:

* Pain in chest when performing physical activity
* Pain in chest when not performing physical activity
* Loss of balance because of dizziness or loss of consciousness
* Recommendation from doctor to only perform physical activity under medical supervision
* No documented diagnosis of knee or hip OA
* Dementia or other memory loss condition
* Active diagnosis of psychosis
* Active Substance abuse disorder
* Total knee or hip replacement surgery, meniscus tear, ligament tear, or other significant lower extremity injury or surgery in the last 6 months
* Severe hearing or visual impairment
* Serious/terminal illness as indicated by referral to hospice or palliative care
* Unstable angina
* Hospitalization for cardiovascular event in last 6 months
* History of ventricular tachycardia
* Unstable chronic obstructive pulmonary disease (2 hospitalizations within the previous 6 months and/or on oxygen)
* Stroke with moderate to severe aphasia
* Recent history (last 6 months) of three or more falls
The Efficacy of Cervical Lordosis Rehabilitation for Nerve Root Function and Pain in Cervical Spondylotic Radiculopathy

To test the hypothesis that improvement of cervical lordosis (CL) in cervical spondylotic radiculopathy (CSR) will improve clinical features in a population suffering from CSR. Thirty chronic lower CSR patients with CL \< 25° will be included. Patients will be assigned randomly into two equal groups, study and control . Both groups will receive neck stretching and exercises and infrared; additionally the study group will receive cervical extension traction. Treatments will be applied 3 time per week for 10 weeks after which groups will be followed for 3-months and 2-years. Amplitude of dermatomal somatosensory evoked potentials (DSSEPS), Cervical lordosis, and pain scales (NRS) will be measured.

Previous studies testing the effects of 3-point bending types of cervical traction, have not clarified exactly what impact the sagittal cervical curve correction has on nerve root function and pain responses associated with improving an abnormal cervical lordosis in cervical spondylotic patients. The present randomized controlled trial will be undertaken to investigate the neurophysiological and pain response outcomes of 3-point bending (2-way) traction compared to standard care in patient cases with lower cervical spine CSR, chronic pain, and with a verified hypo-lordosis of the cervical spine. The primary hypothesis of this study will be that cervical lordosis restoration will have short- and long-term effects on DSSEPs and pain outcomes in CSR patients.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral radiculopathy due to spondylotic changes of the lower cervical spine
* Absolute rotatory angle is less than 20°
* side to side amplitude differences of 50% or more in dermatomal somatosensory evoked potentials measurement

Exclusion Criteria:

* Central spinal canal stenosis
* Rheumatoid arthritis
* Vestibulobasilar insufficiency
* Osteoporosis
* Inability to tolerate the cervical extension position
Prospective Evaluation of Interscalene Nerve Catheters vs. Single Injection Blocks

The primary hypothesis is that those patients who choose an interscalene catheter will have less pain postoperatively than those with single injection blocks. Secondary hypotheses examine physical therapy outcomes and incidence of parasthesia or pain following surgery for up to 3 months.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status 1-3
* 18-79 years of age, inclusive
* body mass index of \< 36 kg/m2.
* The ability to understand local anesthetic related complications and care of a CPNB
* Presence of a caretaker with them during the first 24 hours of local anesthetic infusion, and on a daily basis.
* The ability to communicate with the practitioner managing the catheter.
* Residence within 2 hours of University of Wisconsin Hospital and Clinics

Exclusion Criteria:

* Any contraindication to a continuous interscalene catheter placement
* Clinically significant pulmonary disease
* Clinically significant cardiac disease
* Allergy to ropivacaine
* Peripheral or central nervous system disease
* Current (or planned) anticoagulation therapy or disease
* Local infection over area of catheter placement
* Renal or hepatic failure
* History of opioid dependence
* Significant psychiatric disease
* Pregnancy or lactation (Subjects will be asked if it is possible they could be pregnant. If a subject responds in the affirmative, a pregnancy test will be done.)
* Seizure Disorder
Association of Mood With Risk for Atherosclerosis

The investigators will aim to determine the association of mood disorders (MDO) with preclinical and clinical cardiovascular (CVD) risk factors among children.

The investigators will also aim to identify traditional and non traditional predictors of CVD risk among children with MDO.

This research is being done to determine if mood disorders in children have an impact on stiffness of arteries and/or cause the arteries to not work as well and if MDOs impact blood pressure over a 24 hour period of time.The investigators also want to determine if children with mood disorders have any risk factors or blood tests that can predict how stiff arteries are or how well arteries function and if these are associated with cardiovascular disease risk. The investigators also want to determine if children with mood disorders have greater adverse childhood experiences, worse emotional regulation and poorer quality of sleep. The investigators hope that information from this study could help in earlier detection of cardiovascular disease risk in children.

Eligibility Criteria:
Inclusion Criteria:

* Children Ages ≤ 22 years old
* Enrolled in the CHAMPION Trial and have agreed to be contacted for future studies or children who visit PMP clinic and have MDO and a healthy weight or participants in the Be-HealthY Cohort whose data indicate no history of MDO.

Exclusion Criteria:

* Not able to speak English
* Unable to lie supine
* Significant Arrhythmia
* If participant has used vaso-active drugs the morning of the test (tobacco, caffeine decongestants, or asthma medications).
Hypothyroidism, Metabolism and Quality of Life - Focus on QOL, REE, Cognitive Function and Body Composition

This project has the following primary aims:

The main objective is to delineate the association between changes in Resting energy expenditure (REE) and QOL in hypothyroid patients before and after one year of L-T4 treatment. To achieve this, the investigators plan to compare newly diagnosed hypothyroid patients soon after diagnosis before L-T4 therapy has been initiated after 6 months and after 1 year of treatment.

Primary endpoint is changes in REE compared to changes in QOL Secondary endpoint is changes in cognitive function and changes in body composition before and after one year of treatment and furthermore changes in insulin resistance following changes in body composition and free fatty acids (FFA).

Subjects and Methods:

74 newly diagnosed hypothyroid patients of both genders and age between 20 and 75 years will be recruited from the out-patients clinic in Herlev and Gentofte Hospital and the general practitioners before start of substitution therapy. Participants will get an appointment immediately after diagnosis to avoid unnecessary delay of treatment. Shortly after diagnosis patients will undergo a test panel at the first experimental day, where patients arrives fasting.

* Psychological test using:

  * ThyPRO a thyroid-specific quality of life questionnaire(18),
  * Cognitive function by CALCAP® Abbreviated Test Battery,
  * Perceived cognitive deficit questionnaire (Perceived Deficits Questionaire)
  * Major Depression Inventory (MDI) questionnaire
* REE will be measured by a CCM-express calorimeter,
* DEXA-scan
* Blood samples will be taken and patients will be characterized through basic information.
* Insulin resistance will be assess through an oral glucose tolerance test (OGTT) At end of the first experimental day patients will start L-T4 therapy following national guidelines, with regular control of thyroid hormones to ensure optimal treatment. When patients are euthyroid and TSH is below 4 \* 10-3 International Units pr liter (mU/l) patients will have blood samples monitored every 3 months for the rest of the trial.

After 6 and 12 months of treatment patients will undergo a similar experimental day and return to their general practitioner or outpatient clinic.

A control group of 18 matched healthy persons will undergo the first experimental day in the same way as the hypothyroid patients, except they do not start any kind of therapy and they only participate in the first experimental day.

Eligibility Criteria:
Inclusion Criteria:

* TSH \> 10 mU/liter

Exclusion Criteria:

* Serious competing illness
* Pregnancy or planning to become pregnant
* Thyroidectomized patients
* Unable to speak and understand danish
Short Implant Versus Crestal Standard Length Implant to Retain Class 1 Removable Partial Denture.

Objective: To report the implant survival rates, clinical, and radiographic outcomes of subcrestal short implant versus crestal standard length implant supported removable partial denture (RPD).

30 individuals with at least 2 adjacent missing teeth bilaterally were included.to support class Ι RPD with conventional loading protocol were chosen for this research. Each participant received 2 implants in a split mouth design, one side received 1 subcrestal short implant and the contralateral side crestal standard length implant. Plaque index (PI), bleeding on probing (BOP), probing depth (PD), radiographic crestal bone level (CBL) and implant survival rate were evaluated. at implant placement (T0), restoration delivery (T1), and 3-year follow-up after loading (T2). MBL was calculated as the change in distance from the implant-abutment interface to the first radiographically visible bone-implant contact. A repeated-measures mixed ANOVA followed by a paired Student's t-test with the Bonferroni correction was used for statistical analysis. p \< 0.05 was considered statistically significant

Eligibility Criteria:
Inclusion Criteria

* adult patients aged 50 years or older with class 1 RPD with missing mandibular molars at least and complaining from instability of the prosthesis were recruited.
* Medical history revealed no contraindication to implant therapy.
* Patients have an amount of bone nearly equal to 8 mm length above the inferior alveolar canal to receive a 6 mm short implant with 2 mm subcrestal to the bone level with sufficient bone width ≥ 8mm on one side and an amount of bone equal to or more than 8 mm to receive a standard-length implant of 7.5, 9, or 10.5 mm placed at crestal bone level with sufficient bone width ≥ 8mm on the contralateral side which was examined by CBCT.

Exclusion Criteria:

* Presence of active infection or inflammation in the areas intended for implant placement; \*systemic diseases such as diabetes.
* Pregnant and lactating patients.
* Habit of severe bruxism or clenching.
* Treatment with therapeutic radiation to the head within the past 12 months.
* Treatment with bisphosphonate within the past 12 months.
* More than 10 cigarettes/day smoking habit.
Giant Cell Tumor of the Extremities Treated With Surgery and/or Medical Treatment

The purpose of this project is to present the outcomes of patients with giant cell tumor of bone (GCTB) who were treated with surgery and/or medical treatment in a single institution.

The investigators retrospectively review patients treated for GCTB of the extremities between 1990 and 2013 in a single institution. We evaluate the recurrence free survival rate after surgical and medical treatment of patients with GCTB of the extremities to determine the influence of the surgical approach, denosumab therapy, local tumor presentation, and demographic factors on the risk of recurrence.

Eligibility Criteria:
Inclusion Criteria:

* giant cell tumors of the extremities

Exclusion Criteria:

* giant cell tumors of the spine and pelvis
Daily Chlorexidine Bath for Health Care Associated Infection Prevention

Cluster randomized controlled trial comparing two bathing strategies in critically ill patients. The intervention group will receive daily bathing with chlorhexidine. The control group will receive usual care.

Healthcare-associated infections (HAI) are common complications in critically ill patients and are associated with increased costs, higher length of stay, and higher morbimortality. Data shows that daily chlorhexidine baths might be associated with lower HAI rates in a broad population of critically ill patients. The purpose of this trial is to evaluate the effect of daily bathing with chlorhexidine compared to usual baths (soap and water) on HAI in critically ill patients.

Eligibility Criteria:
Inclusion Criteria:

* All patients ≥ 18 years/old admitted to the participants's ICUs

Exclusion Criteria:

* History of chlorhexidine allergy
Mandala Intervention on Mental Distress in Nurses Working With Terminally Ill Patients

Mandala application intervention of mental distress in nurses working with terminally ill patients

Questionnaires were applied to the control and experimental groups. Mandala painting was done to the experimental group. Questionnaires were applied to the control and experimental groups again. Distress, anxiety, depression, death anxiety, death depression and psychological well-being of the experimental and control groups were evaluated.

Eligibility Criteria:
Inclusion Criteria:

volunteer

* active employee
* year of study

Exclusion Criteria:

* paint allergy
* use of psychiatric drugs Loss of loved one in the last six months