cyrilzakka/clinical-trials huggingface dataset:
A Prospective, Non-randomized Study to Evaluate the Safety and Performance of the NovaCross™ Microcatheter in Femoropopliteal Chronic Total Occlusion (CTO).

Trial is to evaluate the safety and performance of the NovaCross™micro-catheter in respect to providing additional guidewire support that is expected to allow easier crossing of femoropopliteal and infra-popliteal Chronic Total Occlusion (CTO) lesion. The procedure will be conducted on a patient diagnosed with a CTO in a peripheral vessel that requires revascularization.

This is an open label, single center, prospective, first in man pilot study in which the investigational device, NitiLoop micro-catheter, will be tested in up to 15 patients with symptomatic peripheral arterial occlusive disease scheduled to undergo CTO in an anterograde approach.

Eligibility Criteria:
Inclusion Criteria:

1. Adult aged 25-80
2. Patient understands and has signed the study informed consent form.
3. Patient has symptomatic peripheral artery disease (PAD) requiring endovascular revascularization of a CTO, evidenced by angiography, computed tomography or magnetic resonance angiography.
4. Patient has an occluded femoropopliteal or infra popliteal artery
5. Target femoropopliteal or infra-popliteal vessel is ≥ 2.5 mm and ≤5 mm in diameter.
6. Patient has Rutherford-Becker Classification of 2-5.

Exclusion Criteria:

1. Patient unable to give informed consent.
2. Current participation in another study with any investigational drug or device.
3. Patient has a known sensitivity or allergy to contrast materials that cannot be adequately pre-treated.
4. Patient has a known sensitivity or allergy to anti-platelet medications.
5. Patient is pregnant or lactating.
6. Patient has a co-existing disease or medical condition contraindicating percutaneous intervention.
7. Target lesion is in a bypass graft.
8. Target lesion is in a stent (i.e., in-stent restenosis).
9. Patient has had a procedure on the target limb within 7 days.
10. Patient had undergone attempted treatment of the CTO within the prior 3 months (to prevent a guidewire from entering dissection planes created by prior recanalization attempts.
11. Vasculitis and Buerger disease (thrombendarteritis obliterans)
12. Evidence of embolism
13. Peripheral vessel aneurysm
Deep Learning-based System and AIDS-related Cytomegalovirus Retinitis

Ophthalmological screening for cytomegalovirus retinitis (CMVR) for HIV/AIDS patients is important. However, the manual screening with fundus imaging is laborious and subjective.

Deep learning (DL) system has been developed for the automated detection of various eye diseases with high accuracy and efficiency, including diabetic retinopathy, glaucoma, age-related macular degeneration (AMD), papilledema, lattice degeneration and retinal breaks, from ocular fundus photographs. UWF imaging is a relatively new imaging modality for DL system but has also shown extraordinary talents in automatic retinal analysis With the press for routine CMVR screening in AIDS patients and the great capacity of DL system, the use of deep learning (DL) system to AIDS-related CMVR with Ultra-Widefield (UWF) fundus images is promising.

The investigators previously developed a DL system to detect AIDS-related CMVR. For further evaluating the applicability of the DL system, a prospective dataset is needed.


Eligibility Criteria:
Inclusion Criteria:

The UWF images from HIV/AIDS patients.

Exclusion Criteria:

1. The UWF images would be excluded if all three human graders gave different diagnosis.
2. The UWF images with poor quality would be excluded.
Perennial Allergic Rhinitis In Pediatric Subjects

To assess the safety of long-term use of cetirizine dry syrup in children with perennial allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* Children with perennial allergic rhinitis.
* Giving informed consent.
* Children with a positive response to specific IgE antibody test.
* Children assessed as positive in the nasal eosinophil count.
* Children whose severity score of nasal symptom is 4 or higher.

Exclusion criteria:

* have a history of drug hypersensitivity.
* are pregnant, lactating or possibly pregnant female children.
* Sensitivity to pollen as a duplicate allergen and whose treatment periods are thought in the pollen dispersion periods.
* have vasomotor rhinitis and eosinophilic rhinitis.
* have asthma that requires the treatment with corticosteroid.
* have inappropriate complication of nasal disorder that may influence on the evaluation of the study drugs.
* have complicated with atopic dermatitis or urticaria that requires the treatment with antihistamine preparation.
* have started specific desensitization treatment.
* nonspecific modulation treatment but who have not reached the maintenance level of treatment.
* have received surgical treatment for reduction and modulation of nasal mucosa.
* redintegration therapy of nasal cavity to improve the degree of nasal airway.
* surgical operation to improve rhinorrhea.
Sedation Influence on Delirium and Post-traumatic Stress-disorder as a Result of Hospitalization in Intensive Care

The aim of this study is to investigate if sedation of Intensive Care Unit (ICU) patients influences the development of delirium during their ICU stay and if incidences of delirium have an impact on the development of Post-traumatic Stress-Disorder (PTSD).

Hypothesis 1:

Patients who are minimally sedated, remember staying in ICU and experiences fewer episodes of delirium than patients that are heavily sedated

Hypothesis 2:

Former delirious patients are more likely to develop PTSD

Hypothesis 3:

Delirium decreases health-related quality (HRQoL) of life after discharge

Background:

It is known that ICU patients that experience delirium have longer hospital stay, higher mortality and morbidity. Other studies indicate that PTSD, dementia or depression may emerge after discharge from hospital.

Methods according to hypothesis 1:

During ICU stay: Measure sedation level \& delirium. First follow-up 1-2 weeks after ICU: Memories

Analyses:

Data will be analyzed descriptive via EPIDATA and Stata Delirium is endpoint, defined as CAM-ICU positive. Sedation level is exposure variable.

Confounders: priory antipsychotic treatment or hypertension,glasses or hearing aids,alcohol and tobacco abuse,degree of illness,age and sex.

Correlation between sedation level and memories will be calculated.

Methods according to hypothesis 2:

Screening for: PTSD, Depression, Anxiety

Analyses:

PTSD is endpoint, and delirium is the exposure variable. Main confounders: Anxiety and Depression Mean of PTSD will be calculated with Confidence Interval to test any difference between experienced delirium or not.

Methods according to hypothesis 3:

Method:Health-related quality of life is endpoint, Activities of daily living (ADL), Memories, and a Script Test (only after 2 month)

Analyses:

Mean of HRQoL will be calculated with Confidence Interval to test any difference between experienced delirium or not.

Confounders: Diary and/or Follow up

Eligibility Criteria:
Inclusion Criteria:

* ICU-stay \> 48 hours

Exclusion Criteria:

* Severe brain trauma
* Non-Danish-speaking
* Age \< 18 years
* Death (only hypothesis 2 and 3 in the study)
An Extension Study to Evaluate the Efficacy and Safety of HORIZANT in Adolescents With Moderate-to-Severe Primary RLS

The objectives of the trial are to evaluate the long-term efficacy and safety of HORIZANT (Gabapentin Enacarbil) 600 mg daily, for the treatment of RLS in adolescents (13 to 17 years of age) diagnosed with moderate-to-severe primary RLS.

Patients who complete the 12-week daily dosing efficacy and safety study (XP109) will be allowed to enroll in the open-label extension (OLE) study (XP110), thereby providing exposure to HORIZANT for up to 48 weeks. Enrolled patients will take open-label HORIZANT 600 mg tablets once a day at approximately 5 PM with food, beginning at Week 0 of the OLE study up to and including Week 36. After the end of the treatment period, a follow-up visit will be included 14 days (± 3 days) after the last dose of HORIZANT. Patients will visit the clinical site on 6 different occasions, including a follow-up visit 14 days (± 3 days) after the last dose of study drug.

Eligibility Criteria:
Inclusion Criteria:

Patients who completed participation in HORIZANT Study XP109.

* Negative pregnancy test for females of childbearing potential. Male patients able to father a child must agree to use a barrier method (male condom, female condom, diaphragm, or cervical cap) with spermicide for at least 30 days prior to dosing and throughout the study. Fertile, sexually active patients must agree to use 2 medically accepted methods of contraception
* Patients must be willing to refrain from using any drugs that are likely to affect RLS or sleep assessments for the duration of the study.
* Signed patient and parent (or legal guardian) Institutional Review Board (IRB)-approved assent and consent forms before any study procedures are carried out

Exclusion Criteria:

* Patients who, in the opinion of the investigator, would be noncompliant with the study visit schedule, procedures, or medication administration
* Patients who have developed clinically significant or unstable medical conditions, or who would otherwise be unsuitable for participation in a continuation study with gabapentin enacarbil
Characterization of Adalimumab Concentrations in Pediatric Patients With Inflammatory Rheumatic Disease With and Without Methotrexate

This study is to assess standardized Adalimumab (ADA) concentrations in Pediatric inflammatory rheumatic diseases (PiRD) patients treated with ADA for ≥ 12 weeks with and without concomitant methotrexate (MTX) therapy and to assess peak and trough ADA concentrations in ADA naïve patients after first ADA administration with and without MTX (pre-phase).


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of a juvenile idiopathic Arthritis (JIA), uveitis or chronic recurrent multifocal osteomyelitis (CRMO)
* Medical indication for initiation of ADA treatment or established ADA therapy for ≥ 12 weeks
* Exclusion of chronic infections
* No parallel treatment with other biologic medications
* Available patient history since ADA start
* No pregnancy
* Ability to comply with the entire study protocol
* Willingness to participate with signed informed consent

Exclusion Criteria:

* Other rheumatic inflammatory diseases
* Age \< 2 years or \>18 years
* PiRD patients and parents with cognitive impairments preventing to understand study requirements
* Additional severe chronic disease (kidney failure, liver insufficiency), malignancies or prior chemotherapy
Pulmonary Embolism Response to Fragmentation, Embolectomy, & Catheter Thrombolysis: PERFECT

A prospective observational study to evaluate the safety and effectiveness data of catheter-directed therapy (CDT) including percutaneous mechanical thrombectomy (PMT) for treatment of acute pulmonary embolism (PE)

The primary objective of this study is to capture high quality patient safety and effectiveness data on CDT for acute PE. The goal will be achieved by capturing a concise set of immediate and short-term functional and clinical outcome data for PE patients undergoing CDT.

Secondary study objectives include the following:

- To assess and benchmark clinical practice patterns (patient selection, optimal technique, use of procedure worldwide)

These objectives will be achieved through the capture of selected process data for patients included in the registry. Data collected in this study may also be used to develop and refine standards of care for use of CDT for PE and to facilitate the design of randomized clinical trials

Eligibility Criteria:
Inclusion Criteria:

* Must be Age greater than or equal to 18
* Obtain informed written consent.
* Diagnosed with acute pulmonary embolism (PE) (\< 14 days)
* Catheter-directed therapy (CDT) was performed to treat acute PE
Sequence of Vessel Interruption and Circulating Tumor Cells in Surgical Lung Cancer

This study aims to define the impact of the sequence of vessel interruption on change in CTC and CTC clusters density in the tumor-draining pulmonary vein between the period before surgical manipulation and before tumor-draining vein interruption.


Eligibility Criteria:
Inclusion Criteria:

* NSCLC with preoperative pathological evidence,
* Pure solid nodule or part-solid (\>50%) ground glass nodule on CT scan
* Clinical stage tumor-1 to 3, clinical stage node-0, clinical stage metastasis-0, (except clinical stage tumor-3 for chest wall, pericardium or phrenic nerve invasion)
* Video-assisted thoracoscopic lobectomy or bi-lobectomy

Exclusion Criteria:

* Pneumonectomy, segmentectomy, non anatomic resection
* History of thoracic surgery on the same side
* Necessity to perform a non-anatomic resection in addition to the lobectomy
* No preoperative histological diagnosis
* Pure ground glass nodule on CT scan
* Clinical stage tumor-4 or 3 for chest wall, pericardium or phrenic nerve invasion
* Clinical stage node ≥1
* Neoadjuvant therapy
* Second cancer or cancer in the past 5 years
* First approach through thoracotomy with ribs spreading
* Pregnancy, \<18 years of age
* Pulmonary adherences/symphysis found during surgery (impossible to perform the first blood sample without lung manipulation)
Fracture Risk After Pancreas Transplantation (FraPaT)

Individuals with type 1 diabetes (T1D) are at greater risk of fracture than non-diabetic subjects. Although the mechanisms underlying bone fragility in T1D are not completely understood, insulin deficiency seems to play a key role.

To date, no information is available on the effect of diabetes remission after pancreatic transplantation alone (PTA) on the risk of fractures in T1D individuals with preserved kidney function.

The overall objective of this retrospective cohort study is to evaluate the effect of T1D remission after PTA on fracture risk.

The primary endpoint will be the difference in fracture incidence (any fracture) between the PTA group and the control group. For the PTA group, the incidence of fractures after transplantation will be considered.

Data from patients who underwent PTA at IRCCS San Raffaele Hospital from January 2, 2005 to December 31, 2017 will be compared with age-, gender- and disease duration-matched controls from the pool of outpatients with T1D attending the Endocrinology Unit at the same Institution. Anthropometric, anamnestic, laboratory data and data on the history of fractures and past/current therapies will be collected.

With this study, for the first time we will be able to obtain information on the effects of diabetes remission on the risk of fracture. We expect that the remission of diabetes will result in a beneficial effect on the fracture risk.


Eligibility Criteria:
Inclusion Criteria (PTA group)

* T1D patients who received their first PTA, or second PTA only if their first graft was explanted within a week, between 2 January 2005 and 31 December 2017
* age ≥18 and \< 65 years
* willingness to participate in this observational study

Inclusion Criteria (control group)

* Type 1 diabetes
* age ≥18 years and \< 65 years
* willingness to participate in this observational study
* minimum disease duration of 5 years
* brittle diabetes, as defined by the occurrence of frequent acute complications (ketoacidosis or severe hypoglycaemic episodes requiring third-part assistance or unawareness despite well-conducted intensive insulin therapy)
* presence of at least one diabetes-related complication (either neuropathy, retinopathy, subclinical nephropathy).

Exclusion Criteria (both groups)

* conditions other than T1D known to affect bone health (i.e., non-compensated hypothyroidism, hyperthyroidism, hyperparathyroidism, inflammatory bowel disease, malignancy, rheumatoid arthritis, hypogonadism, severe chronic obstructive pulmonary disease, hepatic insufficiency, alcohol intake ≥ 3 units/day ),
* use of drugs that can affect bone metabolism (e.g., bisphosphonates, anticonvulsants, hormone replacement therapy) other than glucocorticoids and immunosuppressants
* recipients of simultaneous pancreas kidney transplantation, pancreatic islet transplantation, multiple PTAs, other transplants
* BMI \<18.5 or ≥ 30 kg/m2
Effect of Degranulation Needle With Different Diameters on the Rate Good Embryo in IVF

Good-quality embryos are critical for the success of in vitro fertilization (IVF). But, to date, there is no report of the effect of different diameters denuding pipette on the embryos quality. To investigate the effect of denuding pipette in IVF outcomes, we plan to recruit women undergoing IVF treatment cycles and classified them into two groups according to the different diameters. Consequently, the rate of fertilization, zygotes cleaved, top quality embryos on D3, and blastocysts obtained were recorded.

Good-quality embryos are critical for the success of in vitro fertilization (IVF). But, to date, there is no report of the effect of different diameters denuding pipette on the embryos quality. To investigate the effect of denuding pipette in IVF outcomes, we plan to recruit women undergoing IVF treatment cycles and classified them into two groups according to the different diameters. The participants were divided into two group. Odd-numbered days the zygotes were degranulated with the 140 microns needles. Even-numbered days the zygotes were degranulated with the 150 microns needles. Consequently, the rate of fertilization, zygotes cleaved, top quality embryos on D3, and blastocysts obtained were recorded.

Eligibility Criteria:
Inclusion Criteria:

* first cyele of IVF treatment

Exclusion Criteria:

* oocyte number less than 4
* oocyte number over than 25
The Incretin Effect in Patients With Gestational Diabetes Mellitus

The aim of this study is to evaluate the reduced incretin effect observed in patients with T2DM in relation to reversibility. The incretin effect will be measured by means of OGTT and iIVGTT in 12 women with GDM during pregnancy (third trimester), and again 2-3 months post partum. It is anticipated that the incretin effect in patients with GDM is reduced - like in patients with other forms of DM. The investigators estimate that approximately 90 % of the patients with GDM re-establish a NGT 2-3 months post partum. This particular group of patients provides a unique possibility for demonstrating the reversibility of the reduced incretin effect in relation to optimal glycaemic control.


Eligibility Criteria:
Inclusion Criteria:

* age above 18 years old
* GDM diagnosed according to WHO guidelines (GDM group) or ruled out by OGTT 75g (Control group)

Exclusion Criteria:

* Previous diagnosis of DM
* Positive GAD-65-autoantibodies and/or positive islet cell autoantibodies (ICA)
* Affected biochemical liver parameters (ALAT \> 2 times normal upper range)
* Affected biochemical kidney parameters (se-creatinine \> 130 µM)
* Treatment with medicine interacting with insulin secretion (e.g. steroids)
* Treatment with medicine that can not be paused for 16 hours
Study Evaluating Three Bazedoxifene/Conjugated Estrogens Combination Tablet Formulations Versus BZA Oral Solution

This study involves the experimental drug bazedoxifene acetate/conjugated estrogens (also called BZA/CE). This drug is not approved by the Food and Drug Administration (FDA).

About 24 subjects will take part in this study. Each subject's participation in this study will last for about 10 weeks. During this study, each subject will receive 3 different types of BZA/CE tablets plus an oral solution containing only BZA. The purpose of this study is to learn how the tablet dosage forms dissolve and are absorbed by the body compared to the BZA oral solution. In addition, information will also be learned about the safety and tolerability of these dosage forms given to healthy postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Generally healthy, nonsmoking (or smoker of less than 10 cigarettes/day)
* Postmenopausal women aged 35 to 70 years
* At least 12 months of spontaneous amenorrhea, OR 6 months of spontaneous amenorrhea with follicle-stimulating hormone (FSH) levels at least 38 mIU/mL
* Women 55 years of older must have at least 12 months of amenorrhea
* Body mass index in the range of 18.0 to 35.0, with a minimum body weight of 50 kg

Exclusion Criteria:

* A history or active presence of clinically important medical disease.
* History or alcoholism or drug abuse within 1 year before study start.
* Use of estrogen-, androgen-, or progestin-containing medication by a non-oral route of administration within 6 months before study day 1 must be approved by Wyeth Research
Secondary Intention Wound Healing Versus Micrografting in Patients Undergoing Mohs Surgery

This study evaluates a novel micrografting technique to see how it will influence the healing rate and cosmetic result of second intention wounds. The graft harvesting and micrografting process was designed by MoMelan Technologies The Epidermal Expansion System, which is composed of a commercially available Blister Generation Device and the Microblister Generation and Excision Device (MBGED), will generate an array of small microblisters and transfer the micrografts to a sterile dressing (Tegaderm™ - an FDA approved wound dressing) for application to the subject's surgical area. The investigators predict that applying expanded micrografts to wounds that otherwise would have healed by second intention alone will hasten healing and possible reduce scarring.

Participants with a scalp wound s/p Mohs procedure will be randomized to a micrografting technique intervention or to no intervention/heal with secondary intention alone (control). Intervention consists of harvesting skin micrografts (1.75mm) from pigmented skin using the Microblister generation and excision device and transfer the micrografts to a sterile dressing for application to the participants scalp wound. Percent wound re-epithelialization will be compared between two groups.

Eligibility Criteria:
Inclusion Criteria:

1. Between 40-75 years old
2. Status post Mohs procedure on the scalp with a wound that would otherwise be allowed to heal by second intention
3. Superficial would-at deepest of 2.0 mm or to superficial fat, but not deep to muscle
4. Area is less then 6 cm2 (wound diameter less than 2cm)

Exclusion Criteria:

1. Female patients who are breastfeeding, pregnant, or planning to become pregnant
2. Abnormal bleeding observed during initial Mohs procedure that would suggest a higher risk of post-operative bleeding
3. Subjects currently on immunosuppressive medications, chemotherapy or a cytotoxic agent
4. Participation in another interventional study with potential exposure to an investigational drug within past 30 days or planned study entry within 90 days after study entrance