cyrilzakka/clinical-trials huggingface dataset:
Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas

This study will assess changes in visual acuity and corneal symmetry after corneal collagen cross-linking (CXL) of asymmetric corneas.

This study will evaluate the results of Corneal Collagen Crosslinking (CXL) in patients with conditions that include keratoconus, forme fruste keratoconus, post-LASIK ectasia, pellucid marginal degeneration, forme fruste pellucid marginal degeneration, diurnal fluctuation post-radial keratotomy, or Terrien's marginal degeneration. This is an outcomes study, all patients receive treatment.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of at least one of the following conditions:

  1. Keratoconus
  2. Forme fruste keratoconus
  3. Post-LASIK ectasia
  4. Pellucid marginal degeneration
  5. Forme fruste pellucid marginal degeneration
  6. Diurnal fluctuation post-radial keratotomy
  7. Terrien's marginal degeneration

Exclusion Criteria:

1. Corneal thickness \< 375 microns measured by ultrasound or Pentacam.
2. Contraindications or hypersensitivities to any study medications or their components.
3. Pregnancy or breastfeeding.
4. Any history of herpes simplex corneal disease in an eye to be treated.
5. Nystagmus or any other condition that would, in the judgement of the investigator, prevent a steady gaze during the treatment.
6. Inability to cooperate with diagnostic tests.
7. Enrollment in another ophthalmic clinical trial.
An Observational Study to Understand Challenges Associated With Progression of Insulin Therapy in Type 2 Diabetes

The purpose of this study is to identify specific patient, physician, and health system related factors associated with the progression to a more intensive regimen from initial insulin therapy for patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Have been diagnosed with type 2 diabetes
* Have presented within the normal course of care
* Have been on their initial insulin therapy for ≥3 months (with or without any combination of approved non-insulin anti-diabetic medications)
* Are not simultaneously participating in a study that includes an investigational drug or procedure at entry into the study
* Have been fully informed and have given written consent for the use of their data
* Have a sufficient understanding of the primary language of the country such that they will be able to complete the questionnaires
* Have not initiated basal bolus therapy (three mealtime insulin injections)

Exclusion Criteria:

* None
Efficacy and Safety of Sirolimus Plus CNI Compared With MMF Plus CNI in ABO-i Kidney Transplant Recipients.

The purpose of this study is to evaluate the efficacy and safety of RaparoBell® Tablet Plus Calcineurin Inhibitors Compared with Mycophenolate Mofetil Plus Calcineurin Inhibitors in ABO incompatible De Novo Living Kidney Transplant Recipients.

This study is Multi-center, Open-label, Randomized Controlled Phase 4 Study to Evaluate the Efficacy and Safety of RaparoBell® Tablet Plus Calcineurin Inhibitors Compared with Mycophenolate Mofetil Plus Calcineurin Inhibitors in ABO incompatible De Novo Living Kidney Transplant Recipients.

Eligibility Criteria:
Inclusion Criteria:

\[Time of Screening\]

1. Patients who plan to be transplanted ABO incompatible living donor kidney or not past 35 days after kidney transplantation
2. More than the age of 19 years old
3. Agreement with written informed consent

\[Time of Randomization\]

1. Patients who have transplanted Kidney within 4 weeks(25 days to 35 days)
2. Patients who take CNI plus MMF after kidney transplantation

Exclusion Criteria:

\[Time of Screening\]

1. Patients who have transplanted non-kidney organs or have plan to be transplanted non-kidney organs
2. PRA \> 50% before desenitization or positive results of DSA
3. Receive a kidney from a related donor who showed HLA identical
4. Positive in serology test(HIV, HBsAg, HCV) in recipients and/or donor
5. Allergic/hypersensitivity reaction in the history of Investigational drugs or additives
6. Women who are pregnant or breast feeding or not agree to the proper use of contraception during the trial
7. Patient has conversation impairment because of mental illness within 6months
8. Participated in other trial within 4 weeks
9. In investigator's judgement

\[Time of Randomization\]

1. Patients with acute rejection who have been clinically treated after kidney transplantation
2. At the time of Randomization

   * Treatment with active liver disease or Liver function test(T-bilirubin, AST, ALT)is over 3 times than upper normal limit
   * WBC\< 2,500/mm\^3, or platelet \< 75,000/mm\^3, or ANC \< 1,300/mm\^3
3. Patients who had plasmapheresis within 1 week
4. Patents who had a record of taking mTOR inhibitor before
5. In investigator's judgement
Bergonie Institute Breast Cancer Database

A database of breast cancer patients was established at Institute Bergonié since the 90s , to assess patients' survival, assess practice, search for prognostic factors.


Eligibility Criteria:
Inclusion Criteria:

* Breast cancer
* Aged 18 years and over
* First treatment at Bergonie Institute

Exclusion Criteria:

-
Preventing Diabetic Foot Ulcers Through Cleaner Feet

Foot complications are among the most serious and costly complications of diabetes. People with diabetes have a 10-fold increased risk for a leg or foot amputation compared to those that do not have diabetes. Amputation of all or part of foot is usually preceded by a foot ulcer, which became infected. This is a clinical trial to test the effectiveness of a topical antiseptic, chlorhexidine, for daily foot cleaning on the occurrence of diabetic foot ulcers in Veterans at high risk of a diabetic foot ulcer.

Population: Up to 200 Veterans at high risk of a diabetic foot ulcer

Site: VA Maryland Health Care System (VAMHCS)

Study Duration: Approximately 5 years

Study Design: Randomized double-blind clinical trial comparing a) a daily foot care regimen with cloths containing 2% chlorhexidine to b) a daily foot care regimen with cloths not containing 2% chlorhexidine

Objectives:

Primary: To determine if chlorhexidine reduces the occurrence of foot complications including chronic foot ulcer, foot infection or foot amputation.

Secondary: To determine if chlorhexidine increases antibiotic resistance among bacterial pathogens on feet.

Exploratory: To describe changes in the microbiota of the feet with chlorhexidine and foot complications

Treatment Regimens: 2% Chlorhexidine Gluconate Cloths versus Bath Cloths

Route of Administration: Topical application on the feet

Dose and Interval: 1 cloth daily

Duration of Participant's Participation: Up to 13 months

Eligibility Criteria:
Inclusion Criteria:

* Adults \>=18 years
* Clinical diagnosis of diabetes
* At high risk for a new diabetic foot ulcer due to: 1)Past history of diabetic foot ulcer or 2)Past history of major foot surgery including partial foot amputation or 3)Past history of major foot infection or 4)Neuropathy and onychomycosis and hemoglobin A1C \>8% or 5)Neuropathy and peripheral vascular disease or 6)Dialysis or 7)Past history of Charcot foot or 8)Past history of peripheral vascular surgery or angiography with stent
* Two feet (can have amputation of part of the foot)
* At least one foot without a foot ulcer
* Permanent mailing address suitable for provision of specimen collection materials and telephone suitable for monthly follow-up
* Able to give written informed consent

Exclusion Criteria:

* Amputation of the foot planned to treat current foot ulcer or wound
* Current foot infection
* Use of topical chlorhexidine on feet 7 days prior to randomization
* History of an allergic reaction to chlorhexidine
* Unable to use wipes for foot care
* Inability to walk
* Life expectancy less than 12 months
* Plans to move out of the area in the next 13 months
* Requires equivalent of institutional care (e.g. nursing home)
* Any other criteria which, in the investigator's opinion, would compromise the safety of the study, the ability of a subject to participate, or the results of the study
First-in-Human Single Ascending Dose of GLPG0492

The purpose of the study is to evaluate the safety and tolerability of single ascending (SAD) oral dose of GLPG0492 compared to placebo in healthy subjects.

Also, pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0492 after single oral administration will be evaluated, and, if applicable, the maximum tolerated dose determined. Oral bioavailability (solution vs solid capsule fasting or fed) is evaluated in healthy elderly subjects.


Eligibility Criteria:
Inclusion Criteria:

* healthy male, age 18-50 years (young subjects) OR ≥60 years (elderly subjects)
* BMI between 18-30 kg/m², inclusive
* non-smoker

Exclusion Criteria:

* elevated PSA
* drug or alcohol abuse
IRDye800CW-BBN PET-NIRF Imaging Guiding Surgery in Patients With Glioblastoma

This is an open-label positron emission tomography/near infrared (PET/NIRF) study to investigate the imaging navigation performance and evaluation efficacy of dual modality imaging probe 68Ga-BBN-IRDye800CW in glioblastoma (GBM) patients. A single dose of 40μg/111-148 Mega-Becquerel (MBq) and 1.0 mg/ml 68Ga-BBN-IRDye800CW will be injected intravenously before the operation and intraoperative respectively. Visual and semiquantitative method will be used to assess the PET images and real-time margins localization for surgical navigation.

Non-invasive preoperative PET imaging evaluation and real-time fluorescence-guided surgery would be of great help in GBM patients. BBN, with the amino acid sequence of Gln-Trp-Ala-Val-Gly-His-Leu-Met-NH2, has been extensively used for the development of molecular probes for the imaging of gastrin-releasing peptide receptor (GRPR), a member of the G protein-coupled receptor family of bombesin receptors that over-expressed in various types of cancer cells including glioblastoma multiforme. For interests in clinical translation of GRPR targeting dual modality probe, an open label dual modality imaging PET/ NIFR study was designed to investigate the safety and imaging guiding performance of 68Ga-BBN-IRDye800CW in patients with GBM.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to provide a written informed consent
* MRI imaging and/or pathological evidence of Newly Diagnosed or recurrence GBM

Exclusion Criteria:

* Consisted of conditions of mental illness
* Severe liver or kidney disease with serum creatinine \> 3.0 mg/dl (270 μΜ)
* Any hepatic enzyme level 5 times or more than normal upper limit
* Severe allergy or hypersensitivity to IV radiographic contrast
* Claustrophobia to accept the PET/CT scanning
* Pregnancy or breast feeding
Using EMR Data and AI to Develop a Passive Digital Marker to Predict Postoperative Delirium

This study will be a pilot randomized controlled trial that will determine the effect of an indicator of delirium risk, which will be delivered either via a paper form or via the electronic medical record, on (1)postoperative delirium incidence; and (2)the development of long term cognitive decline and dementia.

Patients will be recruited from a large general, minimally invasive, colorectal, and oncologic, university-based surgical practice. English speaking individuals over the age of 65 with planned major abdominal surgery (encompassing abdominal wall, gastrointestinal and hepatobiliary procedures for benign and malignant diseases) will be screened for eligibility following an initial visit with their surgeon. Inclusion criteria will include a required inpatient stay for ≥ 24 hours following surgery and a scheduled preadmission testing and medical risk stratification visit with an internal medicine provider. Patients will be excluded if they have severe mental illness, hearing and visual impairment, alcohol intoxication or related delirium, central nervous disorder (e.g., stroke, traumatic brain injury), and pregnant or nursing status. Once enrolled, subjects will be randomized using a computer-generated scheme (permuted blocks of four and six) to the PDM or usual care, stratified according to type of surgery (hepatobiliary, gastrointestinal, abdominal wall).

Eligibility Criteria:
Inclusion Criteria:

65 years old Planned inpatient major surgery requiring inpatient stay ≥ 1 day

Exclusion Criteria:

* Baseline cognitive impairment or a diagnosis of Alzheimer's Disease/Alzheimer's Disease and Related Dementias (AD/ADRD)
* Alcohol or drug withdrawal
* Prisoner status
* Unable to communicate with research staff due to sensory impairments
* Not fluent in English
* Currently has a personal safety attendant
Enhancement of Connect to Protect® (C2P)

The proposed study seeks to continue Connect to Protect® (C2P) community mobilization efforts that have developed coalitions that plan for and bring about structural changes for purposes of reducing HIV incidence and prevalence among youth in targeted communities at nine sites.

Earlier phases of C2P have been outlined in ATN Protocols 016a, 016b, 040/040b. The C2P community mobilization model entails: determining a geographic area and population of focus for the coalitions to prioritize their planning and action (accomplished in an earlier phase of C2P); coalitions establishing a shared vision and mission; development of a strategic plan focused on structural changes to reduce risks associated with HIV; process documentation; and feedback as technical assistance to the coalitions. The National Coordinating Center (NCC), operating under the direction of the Protocol Chair, provides guidance, training, technical assistance and feedback to coalitions.

This protocol continues the C2P mobilization effort and includes enhanced strategic planning activities to assist the coalitions in identifying necessary and relevant structural changes. The evaluation of C2P includes both process evaluation (i.e., documentation of coalition actions and achievements of structural changes; and outcome evaluation to qualitatively assess (via Key Informant (KI) interviews) if and how C2P efforts, including completed structural changes, have influenced the risk environment within each community. In addition, local health surveillance data and HIV testing data will be used to evaluate changes in HIV testing patterns and HIV/Sexually Transmitted Infection (STI) morbidity among youth.

Eligibility Criteria:
Inclusion Criteria:

1. The intervention group = Community members who become engaged in the coalitions and in the broader mobilization effort; and
2. The evaluation group = Key Informants within each C2P community who either work or reside within the sectors or systems where structural changes have been accomplished and/or the coalition has focused their strategic planning efforts.
Acute Gastrointestinal Bleeding Peripheral Pulse Volume Changes

The purpose and aim of this study are to compare changes in pulse volume to non-invasively predict active bleeding or high-risk stigmata in patients undergoing a gastrointestinal endoscopy to assess feasibility of the flow meter clinically.

The maximum change in volume of a limb segment during the cardiac cycle - pulse volume - will be monitored non-invasively along with standard vitals in patients with a suspected gastrointestinal bleed undergoing endoscopy. Pulse volume and vitals will be collected prior to and following endoscopy up to the point of dismissal from the endoscopy unit so that the data may be correlated with the endoscopic and clinical findings.

Eligibility Criteria:
Inclusion Criteria:

- Adults (age \>18yr) undergoing emergent endoscopy for active GI bleeding.

Exclusion Criteria:

* Patients with pre-existing heart failure (ejection fraction \<40%), cardiac rhythm abnormalities and peripheral vascular disease.
* Patients with underlying implanted cardiac electrical devices and spinal cord stimulators.
Promoting Recovery Processes in Women With Borderline Personality Disorder Using a Dynamic Cognitive Intervention

The field of psychiatric rehabilitation focuses on creating a personal narrative and developing coping strategies and environmental supports. The concept of recovery is person-centered and emphasizes the person's ability to change and to live meaningful life. The strengths approach has a central role in the recovery concept, emphasizing the person's abilities and potential. A preserved cognitive ability can be a significant strength in the recovery process.

Research had shown growing support for the use of cognitive-behavioral approaches as the most effective therapy for people with borderline personality disorder, using structured interventions. A central focus in cognitive therapy is the change of maladaptive schemes. The dynamic-cognitive intervention (DCI) is based on the understanding of structural cognitive modifiability and suggests the use of mediated learning in order to enhance sense of competence and develop better psychological coping skills.

The present study will focus on women diagnosed with borderline personality disorder, with normative cognitive ability seen as a strength as opposed to their emotional ability. This study will examine the effects of a Dynamic Cognitive Intervention on recovery measures and on symptoms severity.

The study will include 30 women aged 18-45 years. Participants will be randomly assigned to an intervention group and a control group. All participants will be assessed before and after intervention using Recovery Assessment Scale, Hope Scale and The Brief Symptom Inventory.

The intervention designed for this study is based on the principles of the Dynamic Cognitive Intervention. The intervention tools that will be used include: a. Instrumental Enrichment tools. b. life events analysis. c. Stories, lyrics and movie clips. d. Worksheets. The intervention encompasses 12 sessions of 1.5 hours, with a routine structure.

The results are expected to contribute to the understanding of the impact of a dynamic cognitive intervention in women diagnosed with borderline personality disorder.


Eligibility Criteria:
Inclusion Criteria:

* Women
* Age 18 - 45
* Borderline Personality Disorder, by DSM-V

Exclusion Criteria:

* Current Acute Depressive Episode
* Current Psychotic Episode
* Less Than 12 school years
* Non Compliance with therapy
* Dual diagnosis
Study of the Effect of Food on the Pharmacokinetics of Mirabegron

The purpose of this study is to assess the effect of food on the pharmacokinetics of a single oral dose of mirabegron in healthy male and female subjects.

Subjects will be assigned in a random order to receive 3 dosing regimens:

1. a single oral dose under a fasting condition;
2. a single oral dose with food (low fat breakfast);
3. a single oral dose with food (high fat breakfast).

Eligibility Criteria:
Inclusion Criteria:

* The subject must weigh at least 45 kg and have a body mass index (BMI) between 20.0 and 32.0 kg/m2 , inclusive
* The subject must have a normal or clinically non-significant 12 lead ECG as well as normal or clinically non-significant laboratory test results
* Female subjects must be post-menopausal (defined as at least 2 years without menses), surgically sterile, or practicing effective contraception, and will continue to use effective contraception during the study period. All females must be non-lactating, and must have a negative pregnancy test result
* The subject must have negative test results for drugs of abuse and alcohol screens
* The subject must have good venous access in both arms

Exclusion Criteria:

* The subject has evidence of QTc interval \>430 msec for male, \>450 msec for female
* The subject has liver function test values (ALT, AST, or bilirubin) above the upper limit of normal
* The subject has a history or presence of psychiatric illness, serious active or recurrent infection, or any medical condition or disorder that precludes the subject from participating in the study
* The subject has a previous history of cancer other than basal cell carcinoma or Stage 1 squamous cell carcinoma that has not been in remission for at least 5 years
* The subject has donated or lost ≥ 450 mL blood within 56 days prior to study drug administration or has donated plasma within 7 days prior to study drug administration
* The subject has received or is anticipated to receive a prescription drug within 14 days prior to Day -1 of Period 1 (within 30 days 1 for any long acting treatments such as depot formulations). Subject has taken any over-the-counter (OTC) medications, including complementary and alternative medicines (except for oral contraceptives and occasional use of acetaminophen of up to 2000 mg/day but not more than 4 days per week) within 14 days
* The subject has consumed alcohol, xanthine derivative-containing food/beverages (tea, chocolate), grapefruit juice, grapefruit-containing products or Seville oranges (e.g., bitter marmalade) within 48 hours before admission into the unit
* The subject has used tobacco-containing products and nicotine-containing products within 6 months
* The subject consumes more than 5 units of alcoholic beverages (one unit is 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits) per week, or has a history of substance abuse, drug addiction, or alcoholism within past 2 years
* The subject is known to have hepatitis or HIV-1 and/or HIV-2, or is positive for hepatitis A antibody IgM, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody
68Ga-NODAGA-RGD PET/ CT for Tumoral Neoangiogenesis

This study will assess the potential of the 68Ga-NODAGA-RGD for the evaluation of neoangiogenesis in patients followed for a neoplastic pathology and for whom a18F-FDG (or 18F-FET for gliomas) is indicated for initial extension evaluation or suspicion of recurrent tumor.

The purpose of this study is to assess the value of 68Ga-NODAGA-RGD PET/CT for detection of neoangiogenesis at level of neoplastic processes, in patients, compared to 18F-FDG PET/CT (tumors other than glioma) or 18F-FET PET/CT (patients affected by glioma) and to determine the respective diagnostic contribution of every technique.

Every patient will undergo a routine 18F-FDG (or 18F-FET) PET/CT followed by a 68Ga-NODAGA-RGD PET / CT specific for the study within the next 7 days.

(each image procedure duration: 2h)

The criteria of primary evaluation for each of the techniques will be defined:

* On the images of PET/CT: SUVmax, SUVmoyen, VOI ( mL ), SUV41 % ratio \[mean SUV of pixels ≥ 41 % of the SUVmax\] of lesions / SUV
* On the images of CT: size of the lesions measured in 3D (axial, coronal and sagittal), density in Hounsfield unit (HU)

The 18F-FDG/18F-FET and 68Ga-NODAGA-RGD PET / CTs will be analyzed at first separately then will be compared according to the methods described in the analysis

Eligibility Criteria:
Inclusion Criteria:

* Age ≤ 85 years old
* Karnofsky index: ≥ 80%
* Patients presenting a neoplasic pathology, histologically proven, known to have expressed integrin αvβ3and for which a 18F-FDG (or a 18F-FETfor glioma) is indicated : (1) glioma (WHO I, II-IV), (2) malignant melanoma, (3) cancer of upper respiratory tract, (4) breast cancer,(5) bone metastasis, (6) ovarian cancer, (7) lung cancer,(8) non-Hodgkinian malignant lymphoma with extra- lymphatic nodes extension, (9) neuroendocrine tumors, (10) pancreatic cancer,(11) oesophagus cancer,(12) stomach cancer. 10 patients will be included per type of cancer.
* Informed consent signed

Exclusion Criteria:

* Incapacity to sign the informed consent
* Pregnancy, breastfeeding
* Age \<18 years