cyrilzakka/clinical-trials huggingface dataset:
Sun Protection Factor Assay (SPF Assay 200/2016)

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose).

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
Ultrasonographic Parameters in Stroke Patients With Dysphagia

ultrasonographic parameters in stroke patients with dysphagia


Eligibility Criteria:
Inclusion Criteria: Diagnosis of stroke,

* Agreeing to participate in the study,
* Cognitive competence to understand the test instructions
* Communication skills to respond to the test instructions.

Exclusion Criteria:

* Presence of a neurological disease other than stroke that will cause difficulty in swallowing, -Being illiterate,
* refusing to participate in the study,
* jaw joint problem,
* surgical intervention in the neck area that will affect ultrasound measurements,
* infected open wound
Effect of Colchicine on the Progression of Aortic Valve Stenosis - a Pilot Study

COPAS pilot is a pilot single center double blinded randomized study to determine the effect of targeted anti-inflammation therapy using colchicine, on valvular calcification activity using imaging, i.e. aortic valvular NaF uptake. The current proposal uses a randomized design to evaluate the effect of colchicine vs. placebo on valvular calcification activity over 6 months measured using NaF PET

COPAS pilot is a pilot single center double blinded randomized study. The investigators will compare the effect of colchicine (0.6 mg daily - intervention arm) vs. placebo (control group) on the 18F NaF aortic valve uptake in patients with mild to moderate AS defined by a mean pressure gradient measured using transthoracic echocardiography (TTE) between 15-25 mm Hg after a 6-month period of treatment. The investigators plan to enroll 12 patients (6 males/6 females) in each arm (total sample size: 24 patients). Primary endpoint is the change in 18FNaF aortic valve uptake between baseline and 6 months in each arm. Parameters of interest are the maximal and total standard uptake values (SUVs) and tissue-to background ratios (TBRs) at the level of the aortic valve.

Eligibility Criteria:
Inclusion Criteria:

1. mild to moderate aortic stenosis defined by a mean pressure gradient using transthoracic echocardiography (TTE) between 15-25mmHg.
2. age greater than18 years;
3. given informed consent.

Exclusion Criteria:

1. bicuspid aortic valve
2. associated moderate to severe aortic regurgitation
3. associated other valvular pathology of moderate or greater severity
4. LV dysfunction (EF\<50%);
5. decompensated heart failure;
6. active infection (e.g. pneumonia, active skin infections, and on antibiotics);
7. chronic diarrhea;
8. immune compromise (e.g. recurrent infection);
9. history of cancer within the last 3 years (other than a successfully treated cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix).
10. active inflammatory conditions (e.g. rheumatoid arthritis, chronic inflammatory bowel disease, SLE, systemic anti-inflammatory therapy (e.g. prednisone, methotrexate));
11. pregnancy (all women of child bearing potential will have a negative BHCG test;
12. breastfeeding;
13. Women of childbearing potential who refuse to use two forms of contraception (this includes at least one form of highly effective and one effective method of contraception) throughout the study OR men capable of fathering a child who refuse to use contraception.
14. glomerular filtration rate (GFR) \<50 ml/min/1.72m2;
15. Use of p-glycoprotein inhibitor (e.g. cyclosporine, verapamil, or quinidine) or a strong CYP3A4 inhibitor (e.g. ritonavir, clarithromycin, or ketoconazole);
16. Hemoglobin \< 105(women) \<110 (men) g/L; WBC \< 3.0x 10(9)/L, platelet count\< 110x 10(9)/L;
17. Patient with a history of cirrhosis, chronic active hepatitis or severe hepatic disease or with alanine aminotransferase (ALT) levels greater than 3 times the upper limit of normal.
18. unable to give informed consent
Atrial Fibrillation Ablation Device Comparison Study

Atrial fibrillation is an irregular heart rhythm which requires long term anticoagulation to prevent risk of stroke and long term poor outcomes. At the same time one have heart surgery, a small additional procedure can be done to treat atrial fibrillation. Surgeons have a choice of six different devices that he or she can use to treat your atrial fibrillation. It is not known at this point which device is best at treating you, as each device seems to have the same success rate at curing atrial fibrillation. One of the six devices will be selected randomly by card pulled out at the time of enrollment. It is therefore the purpose of this study to compare the devices to each other and to follow up after surgery to determine if any one device is best. This information will be valuable to surgeons and to patients as the treatment for atrial fibrillation develops in the future.

Surgery has been used as a treatment for atrial fibrillation (AF) for more than 20 years. Although highly successful, it has not been widely adopted because operations designed to cure AF require extensive cutting and suturing of the heart, inflicting a significant risk on the patient. Newer technologies now permit the surgeon to create similar scars on the heart as cutting, but much more quickly and safely than before.

Over the last ten years at least six different devices have been developed, each of which can scar the heart: Microwave, radiofrequency, ultrasound, laser and cold are some of them. Although there are many papers in the literature studying these devices, each seems to cure about 80% of patients with very low risk of morbidity and/or mortality. This leaves the surgeon with almost no basis upon which to base his or her selection of a device: Which is the best? Which should be used? Therefore, a comparison study is like this is desperately needed.

At the time of the surgery, surgeon who perform the AF treatment, he or she will select one of the six devices mentioned above at randomly assigned earlier, at the time of the enrollment. The device will be used to make scars on your heart exactly as described in the manufacturer's instructions and according to the surgeon's experience. The operation will then be completed per routine. In other words, the only part of the procedure that will be done differently from any other is that the actual device chosen to perform the ablation will vary from one study subject to another.

Patients will be followed up upto one year with EKGs, Holter monitors, MRI's, 6 minute walk tests, echocardiograms, blood tests like bNP and quality of life questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing concomitant cardiac surgery who also have AF.

Exclusion Criteria:

* Patients undergoing re-do or emergency procedures
* Females of child-bearing age who are pregnant
* Age less than 19 and more than 75 years old
Osteofibrous Dysplasia (Kempson-Campanacci's Disease)

The aim of the present study is to obtain long term follow-up in patients with osteofibrous dysplasia, to assess natural history of the disease, late results of treatment and in particular the potential and risk of progression to adamantinoma.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients treated at Rizzoli Institute from 01 Jan 1943 to 31 Dic 2011
* Diagnosis of osteofibrous dysplasia pathologically confirmed
* Written informed consent prior to any study-specific analysis and/or data collection

Exclusion Criteria:

* Patients with histological diagnosis different from osteofibrous dysplasia
A Study of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy (0431-054)(COMPLETED)

The clinical study determines the safety and efficacy of Sitagliptin (MK0431) in patients with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients have type 2 diabetes mellitus on diet/exercise therapy

Exclusion Criteria:

* Patients have type 1 diabetes mellitus
Post-Operative Pain Scores and Analgesic Requirements After Elective Inguinal Herniorrhaphy

The study will investigate the effects of single dose pre-operative oral dose of gabapentin (1200) on post -operative pain scores and oral analgesic requirements.

The study will benefit patients in reducing post-operative pain scores as well as reduction in oral analgesic consumption. Gabapentin has been shown to reduce post operative pain pain scores in breast surgery, hysterectomy , spinal surgery, orthopedic and thyroid surgery

Eligibility Criteria:
Inclusion Criteria:

* Subjects having elective surgery with open unilateral Inguinal herniorraphy

Exclusion Criteria:

* Non elective surgery
* Patients currently on gabapentin therapy
* Patient hypersensitive to gabapentin surgery
* History of alcohol or drug abuse
* Patients who are pregnant or who are nursing
Multiple Instrumentation for ACL Reconstruction Regarding Bacterial Contamination

To determine the Effect of multiple instrumentation regarding bacterial contamination in transportal and transtibial techniques in ACL reconstruction .A Randomized controlled study

Infection is a catastrophic and one of the most dreaded complications in orthopaedic surgery. Several measures have been undertaken to reduce the risk of infection, one of which is the use of systemic prophylactic antibiotics.

The purpose of this study is to determine the effect of multiple instrumentation regarding bacterial contamination in transportal and transtibial techniques in ACL reconstruction . About Eighty consecutive patients having surgical indication for ACL-R will be included, the cases will be divided into two groups, 35 cases will undergo for the transtibial technique and the other 45 cases will undergo for the transportal technique. After preparation, swabs will be obtained from subcutaneous tissue at antromedial portal track in transportal technique (femoral tunnel drilling) and in transtibial technique before and after the instrumentation and femoral screw insertion, a control sample will be taken at antrolateral track in both techniques, then samples will be sended to the lab to be studied.

Eligibility Criteria:
Inclusion Criteria:

1. Isolated ACL Injury.
2. Non deformed knee.

Exclusion Criteria:

1. Associated knee injury (eg. PCL).
2. Deformed knee ( eg. genu varus , genu valgus more than 4 degree )
3. patient with medical history of being immune compromized patient eg,DM
Assessment of the Effect of Output on New Adhesives

The study investigates the impact real output has on adhesion of new adhesives


Eligibility Criteria:
Inclusion Criteria:

* Have given written informed consent
* Be at least 18 years of age and have full legal capacity
* Have had a stoma for more than one year
* Have intact skin on the area used in the evaluation
* Has a stoma with a diameter up to (≤) 35 mm
* Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist)

Exclusion Criteria:

* Currently receiving or have within the past 2 month received radio- and/or chemotherapy
* Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment.
* Are pregnant or breastfeeding
* Having dermatological problems in the peri-stomal- or abdominal area (assessed by investigating scientist)
* Actively participating in other interventional clinical investigations or have previously participated in this investigation.
Safety Study of Clinical and Immune Effects of Phosphodiesterase 4 (PDE-4) Inhibitor in Cutaneous Lupus Patients

The purpose of this study is to determine the clinical and immunological effects of the phosphodiesterase type 4 inhibitor, CC-10004, on skin inflammation associated with cutaneous lupus erythematosus.

Discoid cutaneous lupus is the most common cutaneous manifestation of lupus erythematosus, a chronic, immune mediated disease of unknown etiology. The immune processes underlying cutaneous lupus remain largely unexplored, but recent evidence suggests a role for dendritic cells (DCs), type 1 interferons (IFN) and Th1-type immune processes. Treatment of cutaneous lupus remains limited primarily to anti-malarials, with thalidomide an effective secondary agent. However, side effects associated with these treatments are potentially problematic with chronic use. Phosphodiesterases (PDE) are critical enzymes that degrade cAMP. In particular, PDE type 4 (PDE4) activity is found in inflammatory and immune cells, including DCs. The immune modulator CC-10004 is a PDE4 inhibitor with demonstrated low toxicity in phase I and II clinical studies with potential efficacy in cutaneous lupus. CC-10004 is a well-tolerated, selective PDE4 inhibitor with demonstrated inhibitory effects on Th1-type cytokines and other inflammatory mediators and is under development for the treatment of inflammatory and immune mediated conditions. Prior studies include pilot trials in psoriasis and exercise-induced asthma, with results suggesting clinical efficacy in the former study. This open label, pilot study of 16 weeks duration will explore the clinical and immune-modulating effects of CC-10004 in 10 cutaneous discoid lupus patients. Patients meeting study criteria will receive the drug for 12 weeks, followed by a 4-week washout period. Study visit time points will include weeks 0, 1, 2, 4, 6, 8, 10, 12 and 16, during which we will measure outcomes for clinical, immunological and safety parameters. To investigate early immunological changes occurring in response to treatment, we will also perform skin punch biopsies of lesional sites at week 0 and week 4 for immunohistochemical and molecular analysis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cutaneous discoid lupus by clinical and histopathological exam

Exclusion Criteria:

* Systemic lupus involving the internal organs
* Systemic vasculitis
* History of other clinically significant disease process
* History of HIV, hepatitis B or C
* Concurrent use of immune modulating therapy
* Evidence of incompletely treated tuberculosis
* Pregnant or lactating female
Comparison of Metal and Plastic Stents for Preoperative Biliary Decompression

Covered self expandable metal stents (CSEMS) are three times larger in diameter than 10 Fr plastic stents. When compared to plastic stents, randomized trials have shown longer patency and fewer stent-related complications for CSEMS. The investigators hypothesize that placement of CSEMS would be a better treatment option for preoperative biliary decompression in patients with pancreatic cancer.

Covered self expandable metal stents (CSEMS) are three times larger in diameter than 10 Fr plastic stents. When compared to plastic stents, randomized trials have shown longer patency and fewer stent-related complications for CSEMS. The investigators hypothesize that placement of CSEMS would be a better treatment option for preoperative biliary decompression in patients with pancreatic cancer as there will be better drainage of the obstructed biliary system with fewer adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pancreatic cancer and mass in the head of pancreas causing jaundice.
* Patients 19 yrs of age and older
* Serum bilirubin \> 2mg/dl
* CT: No evidence of distant metastasis or local vascular invasion (tumor surrounding portal or mesenteric vessels for more than 180 degrees of their circumference or an irregular vessel margin).

Exclusion Criteria:

* Karnofsky score \< 60
* Prior (ERCP or PTC) attempts at biliary decompression for the same indication
* Tumor-related gastric outlet obstruction (vomiting and oral intake of \< 1L/day)
* Ongoing or planned neoadjuvant therapy
* Cholangitis at presentation or coagulopathy needing reversal medication
* Post-surgical anatomy
* Multiple extra-hepatic biliary strictures or concomitant stricture in liver hilum
* Failed ERCP's (Definition: Inability to deploy a biliary stent thereby requiring a PTC or surgery).
Biofeedback Rehabilitation in Parkinson's Disease

Background: In this study, a new biofeedback system for balance and gait rehabilitation (Gamepad) was developed. The system, based on wearable inertial sensors, provides users with real-time visual and acoustic feedback about their movement during functional tasks. Gamepad was applied on subjects with Parkinson's disease (PD) in a pilot randomized controlled trial to investigate its feasibility and efficacy versus conventional physiotherapy. The investigators hypothesized that Gamepad system can be easily applied in clinical settings and that biofeedback training with Gamepad provides larger improvements of balance and gait in PD subjects, respect to conventional physiotherapy.

Methods: Forty-two PD patients underwent a 20-session training for balance and gait (45 minutes per session, 3 sessions per week). Participants were randomized into Gamepad Group (biofeedback rehabilitation with Gamepad system), and Control Group (conventional physiotherapy). Clinical and instrumental assessments were performed by a blind examiner pre-, post-intervention and at 1-month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Hoehn-Yahr stage 2 to 4.
* Ability to stand up more than 10 s and inability to stand on one foot more than 10 s.
* Ability to walk for at least 6 m even with an assistive device.
* Stable drug usage.

Exclusion Criteria:

* Mini-Mental State Examination \< 24.
* Implanted deep brain stimulator.
Knowing and Remembering: Cognitive and Neural Influences of Familiarity on Recognition Memory in Early Alzheimer's Disease

Unrandomized, unblinded, monocentric comparative Functional Magnetic Resonance Imaging study.

Prospective functional Magnetic Resonance Imaging study involving a group of participants with Mild Cognitive Impairment due to AD and a control participants group matched for age, education level, verbal Intelligence Quotient as assessed through the French version of the National Adult Reading Test and income group following National Institute of Statistics and Economics Studies classification.

Eligibility Criteria:
Inclusion Criteria:

Volunteers (pilot phase)

* Aged 25 - 75
* French native speakers
* Right-handed
* Education level equal or superior to primary school leaving certificate
* Free from any medical or psychiatric condition that may impact cognition
* Having given written informed consent

Volunteers (experimental phase)

* Aged 60 - 75
* French native speakers
* Right-handed
* Education level equal or superior to primary school leaving certificate
* Free from any medical or psychiatric condition that may impact cognition
* Having given written informed consent

AD-MCI participants

* Aged 60 - 75
* French native speakers
* Right-handed
* Education level equal or superior to primary school leaving certificate
* Fulfilling criteria for " AD-MCI " (Albert et al., 2011)
* Have been seen in a memory medical center or in Memory Resources and Research Medical Center for cognitive symptoms
* Free from any medical or psychiatric condition that may impact cognition
* Able to understand and consent
* Having given written informed consent

Exclusion Criteria:

MRI contraindications (all participants)

* Claustrophobia
* Wearing of any metal implant such as:

  * Heart pacemaker
  * Iron-magnetic surgical clips
  * Any metallic foreign body in the eye or brain

Other criteria (all participants)

* Significant history of neurological or psychiatric disorders
* Ongoing medication that may affect cognitive performances
* Sensory deficit that may interfere with the experimental design (e.g. uncorrected visual impairment)
* Lack of sufficient cooperation during the cognitive tasks
* Persons under major legal protection and/or deprived of liberty

Other criteria (control participants)

- Global cognitive impairment attested by Mattis Dementia Rating Scale or Mini-Mental State Examination, according to available normative data

Other criteria (AD-MCI participants)

* 7 items modified Hachinski ischemic score \> 2 (Hachinski et al., 2012)
* Dementia (McKahn, et al., 2011)
Self-efficacy Scale for Mothers of Premature Babies

The aim of this study is to develop a scale to determine the self-efficacy of mothers of premature infants in individualized developmental care practices.

This study consists of two stages. In the first stage, it is planned to develop a scale to determine the self-efficacy levels of mothers of premature babies based on individualized developmental care. In the second stage, the scale will be applied. At this stage, families will be trained for individualized developmental care and the effectiveness of the education will be evaluated through the developed scale.

For the first stage of the study, it is stated in the literature that at least 5 times the number of items should be taken in determining the sample size during the scale development stage, and 10 times in order to increase the reliability of the scale. In this study, after creating the scale items, a pilot application will be made with 3 mothers. Feedback will be received from mothers regarding the clarity of the questions and the scale will be finalized according to the feedback received. Then, the scale will be applied to the participant with a size of at least 10 times the number of scale items.

For the second phase of the study, firstly, a preliminary application will be made with 10 mothers who meet the inclusion criteria and agree to participate in the study. The number of samples to be taken for the second stage of the research will be determined by performing power analysis with the findings obtained. Mothers included in the preliminary application will not be included in the study. It is planned to use stratified block randomization method in the study. First, mothers will be stratified according to their education level and the total number of children they have, then an equal number of (blocking) mothers will be assigned to each group.

Data will be collected after obtaining written permission from the institution where the research will be conducted. "Descriptive Information Form", "Informed Voluntary Consent Form" prepared by the researchers and "Individualized Developmental Care Based Premature Baby Mothers' Self-Efficacy Scale" will be used in data collection.


Eligibility Criteria:
Inclusion Criteria:

* Mothers of premature babies whose babies were discharged from the Neonatal Intensive Care Unit (NICU) (training will be given immediately after the baby is discharged),
* Continuing prematurity of the baby according to the corrected age,
* Full-time care of the baby at home by the mother,
* Mothers can speak and understand Turkish,
* Voluntary written and verbal informed consent was obtained from the mothers.

Exclusion Criteria:

* Being a term baby
* The mother has an ongoing psychological diagnosis,
* The mothers' unwillingness to continue working at any stage of the study.