cyrilzakka/clinical-trials huggingface dataset:
Micropulse Laser Trabeculoplasty as Adjunctive Treatment in Patients With Pseudoexfoliation Glaucoma

This study aims to evaluate the effect of a single session of micropulse laser trabeculoplasty (MLT) on cornea in eyes with primary open glaucoma (POAG) and pseudoexfoliation glaucoma (PEXG).

Patients with PEXG under prostaglandine analogue monotherapy with inadequate IOP control are treated with 360-degrees 532nm MLT.

Patients are evaluated at 1 day, 1 month, 3 months, 6 months and 12 months post-MLT. After trabeculoplasty patients are maintained in treatment with the same drug regimen as pre-MLT.

Eligibility Criteria:
Inclusion Criteria:

* Patients with POAG or PEXG under treatment with glaucoma agents requiring additional reduction of IOP, age older than 18 years, patients willing to provide informed consent to participate in the study and to adhere to the follow-up schedule.

Exclusion Criteria:

* pre-existing corneal pathology or scar, history of any previous ocular surgery or any planned ocular surgery during the study, history of prior laser trabeculoplasty, end-stage glaucoma with advanced visual field defect, monocular patients, history of trauma, and concurrent systemic or topical steroid use
* patients unable to present for follow up
Endometrial Markers and Response of Endometriosis Patients to Prolonged GnRH Agonist Prior to IVF

This prospective randomized trial evaluates whether one can predict which infertile women with endometriosis who are candidates for in vitro fertilization will benefit from prolonged therapy with a GnRH agonist by the determination of the absence of endometrial expression of the integrin, alpha v, beta 3 vitronectin. This is a prospective randomized trial in which all patients will undergo endometrial biopsy prior to initiation of ovarian stimulation for in vitro fertilization and then undergo randomization to a three month course of a depot preparation of the GnRH agonist leuprolide acetate in depot suspension prior to ovarian stimulation or standard therapy. prio

See summary

Eligibility Criteria:
Inclusion Criteria:

* Infertility
* Surgical diagnosis of endometriosis
* Normal ovarian reserve testing
* Regular menses

Exclusion Criteria:

* Irregular menses
* Undiagnosed abnormal uterine bleeding
* Pregnancy
* Prior adverse reaction to any GnRH agonist
* Ovarian cystic or solid mass \> 3cm in mean diameter at study entry
* Use of a depot preparation of a GnRh agonist or any hormonal therapy for endometriosis within 6 months of study entry
* Current hepatic, renal, hematologic or psychiatric disorder
A Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Oral PTH (1-34) Formulations in Healthy Subjects

This study will have one stage consisting of multiple treatment visits. The study is designed to assess the safety and bioavailability of Entera's oral PTH(1 - 34) in adult male healthy volunteers in various formulation. The study is also designed to assess the reproducibility of pharmacokinetic profiles with various formulations.


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed consent to the study.
2. Males ,aged 18 - 50 years, BMI 18-30 kg/m2, inclusive,
3. Subjects able to adhere to the visit schedule and protocol requirements
4. Hematology ,Chemistry and Urinalysis values with no clinical significance or do not reflect a medical condition which according to the physicians' judgment might confound the results of the study or pose additional risk to the subject by participation in the study.
5. Hemoglobin level \> 12.5 g/dl
6. Blood pressure levels with no clinical significance.
7. Negative serology to HIV, Hepatitis B, Hepatitis C.
8. No known drug and alcohol abuse
9. Negative urinary drugs of abuse at screening
10. No sensitivity to dairy products
11. No allergy to soy bean products.
12. No prescription medications taken within one month to enrollment
13. Over-the-counter drugs (including vitamins) taken within 14 days prior to visit 2 are subject to the investigators' discretion for inclusion.
14. No subjects with previous urolithiasis.
15. Non-smoking In good health as determined by past medical history, physical examination, vital signs, electrocardiogram and laboratory tests at screening

Exclusion Criteria:

1. Concurrent therapy that, in the Investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study medication.
2. Treatment with any investigational product within the last 30 days, enrollment or intention to enroll in any active study involving the use of investigational devices or drugs.
3. Presence of any other condition or circumstance that, in the judgment of the Investigator, might increase the risk to the patient or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
4. Active infections
5. History of drug or alcohol abuse
6. Known allergies or sensitivities to components of study treatment or study procedures, including Soy.
7. Clinically diagnosed psychiatric disorders that may interfere with patient study participation
8. Medical history known or suspected to increase risks of AEs related to study drug, up to the investigator's discretion
9. Chronic illnesses, up to the investigator's discretion
The CORE Buprenorphine Project - An HIV Primary Care Program Demonstration

The goal of this study is to develop and evaluate an innovative model of care to better serve patients who are both HIV-infected and opioid-dependent.

Hypothesis: HIV, opioid dependent patients provided agonist therapy at the site of their primary care will have better retention, utilization of services, health, social and quality of care measures and psychiatric treatment outcomes.

The Buprenorphine Project is an examination of two methods of service delivery. The purpose of this study is to assess the feasibility, cost and effectiveness of an intervention designed to integrate buprenorphine treatment for opioid dependence into HIV primary care at the CORE Center. For this project we will provide buprenorphine to 60 opioid dependent patients at any one time and will compare this on-site treatment group to 60 opioid dependent HIV+ patients who select off-site methadone or no agonist treatment at the time of enrollment.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Patient of the CORE Center
* HIV-infected (confirmed by HIV assay results)
* Opioid-dependent (by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision \[DSM-IV-TR\] criteria)
* Fluent in English or Spanish
* Planning to stay in Chicago area for the next 12 months

Exclusion Criteria:

* Liver function tests (LFTs) (transaminase only) at 5 times or higher than normal
* DSM-IV-TR criteria for benzodiazepine abuse or dependence within the past 6 months
* DSM-IV-TR criteria for alcohol dependence within the past 6 months or actively suicidal
* Psychiatric impairment that impedes ability to consent
* Methadone dose exceeds level allowing for safe transition to buprenorphine
* Pregnant women or women actively trying to become pregnant
* Clinical judgement that patient is inappropriate for medical or psychiatric reasons
Edessy Stem Cell Score (ESS), Endometrium, Endometrioma

Purpose of this study is to evaluate stem cell expression (SCE) in endometriotic (E) and non endometriotic ovarian and endometrial tissues.

This study was conducted on 40 women at Al-Azhar University Hospitals. They are divided into two equal groups, group 1 with ovarian endometrioma and group 2 with normal ovary. Ovarian and endometrial samples were evaluated by hematoxlin \& eosin for histopathology (HP) and of oct-4 for immunohistochemistry (IH) for SCE.

Evaluation of IH parameters revealed that the most important factors for evaluating SC were arranged as score ( Edessy Stem Cell Score=ESS).

Eligibility Criteria:
Inclusion Criteria:

* 20 to 40 years and did not receive hormonal treatment for three month

Exclusion Criteria:

* Diabetes mellitus, cardiovascular and kidney diseases, adenomyosis, Uterine fibroid Endometrial carcinoma and Poly cystic ovary
Pharmacokinetics of AP214 Acetate in Patients Undergoing Cardiac Surgery

The purpose of the present research study is to investigate the pharmacokinetics, as well as safety, tolerability and pharmacodynamics of different ascending dosing regimens of AP214 in patients undergoing cardiac surgery. AP214, the investigational drug, is being developed to potentially prevent post-surgical kidney injury after thoracic aortic aneurysm repair.


Eligibility Criteria:
Inclusion Criteria:

1. Has signed the trial-specific informed consent form.
2. Patients ≥ 18 years old, male or female, not of childbearing potential (postmenopausal or permanently sterilized, e.g. tubal ligation, hysterectomy, bilateral salpingectomy), regardless of ethnicity.
3. Patients undergoing CABG, valve(s), CABG/valve(s) and/or aortic root or ascending aortic aneurysm repair surgery.
4. Cleveland Clinic Renal Score ≥ 2 (higher than average risk for AKI).
5. EF ≥ 30%, evaluated within 2 months prior to screening visit.

Exclusion Criteria:

1. Cardiac surgery to be performed "off pump" without cardiopulmonary bypass.
2. Circulatory arrest in connection with aortic root or ascending aortic aneurysm repair surgery.
3. Confirmed or suspected endocarditis.
4. Requiring a reoperation on one of the valves within 3 months following the original valve surgical procedure.
5. Receiving Aprotinin during the trial, from Screening to Day 90.
6. Having undergone cardiovascular catheterization ≤ 48 hours prior to scheduled surgery.
7. Active peptic ulcer disease and gastritis.
8. Hemoccult positive stools, hematological, bleeding, and coagulation disorders.
9. Receiving dopamine at renal doses (2-4 mcg/kg/min), from Screening to Day of surgery.
10. S-Creatinine greater than 2.1 mg/dl.
11. Known or suspected hypersensitivity to the investigational medicinal product.
12. Known or suspected hypersensitivity to Ondansetron or other selective 5-hydroxytryptamine 3 (5-HT3) receptor antagonists.
13. Current participation in any other interventional clinical trial.
14. Previously dosed with AP214.
15. Use of investigational medicinal products within the previous 6 months.
16. Body weight above 140 kg.
17. History of any organ transplant.
18. Women who are of childbearing potential, pregnant, or breast-feeding.
19. Current abuse of alcohol or substance, according to the investigator's medical judgment.
20. Has a mental incapacity or language barriers precluding adequate understanding of trial procedures.
21. Is considered by the Investigator unsuitable to participate in the trial for any other reason, for instance due to a significant serious underlying condition.
Effects of Ecological Rythmic-acoustic Stimulation (E-RAS) on Motor Skills in Individuals With Parkinson's Disease

The use of rhythmic auditory stimulation (RAS) has been proven useful in the management of gait disturbances induced by Parkinson's disease (PD). Typically, the stimuli used to provide RAS consist of metronome or music-based sounds, which are not related with the auditory experience of walking. Based on previous laboratory research, it is hypothesized that the use of ecological sounds deriving from biological motion (i.e., footstep sounds) could have a greater impact compared to artificial sounds (i.e., metronome sounds), within a rehabilitation program. In a double-blind experiment, it was investigated the effects of 5 weeks of supervised rehabilitation integrated with RAS. Thirty-two individuals affected by PD (age 68.2 ± 10.5, Hoehn and Yahr 1,5-3) were randomly assigned to one of the two conditions (artificial vs. ecological sounds). Spatio-temporal parameters of gait and clinical variables were assessed before the rehabilitation period, at its end, and after a 3-month follow-up. The results revealed that the rehabilitation program integrated with RAS had positive effects on the majority of objective and subjective measures, independently of the type of sound. However, when the two groups were examined separately, the patients assigned to the ecological RAS condition were the only who improved both in terms of cadence and gait speed. Overall, the hypothesized greater effect of the ecological sounds compared to artificial sounds was only partially supported by data.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of PD according to the UK Brain Bank criteria;
* ability to walk independently;
* absence of relevant hearing impairments which could prevent the correct perception of the auditory cues;
* absence of significant cognitive impairment (i.e., Mini-Mental Status Examination (MMSE) \> 24; Frontal Assessment Battery (FAB) \> 13);
* absence of psychiatric or severe systemic illnesses;
* mild-to-moderate disability assessed by means of the modified Hoehn and Yahr (H\&Y) staging scale (1,5 ≤ H\&Y ≤ 3);
* no engagement in any rehabilitative program in the 3 months before the beginning of the study

Exclusion Criteria:

-
Pancreatic Intraepithelial Neoplasia (PanIN) and the Association With Recurrence of Pancreatic Adenocarcinoma

The research purpose of this project is to create a registry, and blood and tissue bank for individuals at high-risk for pancreatic cancer. We plan to conduct histopathological and molecular analysis of resected pancreatic tissue prospectively collected from a cohort of pancreatic cancer patients.

Pancreatic cancer is the fifth leading cause of cancer-related death in the United States. In order to improve outcomes of this disease, significant research efforts have focused on understanding the changes that occur in the pancreas prior to tumor occurrence. The types of changes most often associated with tumor have been named pancreatic intraepithelial neoplasia (PanIN). It is not yet clear how to identify the PanIN lesions most likely to develop into cancer and the length of time required for this progression. In order to evaluate these questions, we are interested in examining the microscopic and genetic characteristics of PanIN lesions in two "high-risk" patients: 1) patients who underwent surgery for pancreatic cancer and developed tumor recurrence after surgery and 2) patients with a strong family history of pancreatic cancer or with a genetic syndrome that puts them at risk for pancreas cancer. The surgical specimens from these patients will be evaluated by a pathologist for evidence of widespread PanIN lesions. In addition, PanIN lesions will be tested for abnormalities in several major genes that are known to be important in pancreatic cancer.

Eligibility Criteria:
Inclusion Criteria:

* Tissue-confirmed diagnosis of pancreatic adenocarcinoma.
* Underwent surgical resection for adenocarcinoma at Columbia-Presbyterian Medical Center with pathologically negative surgical margins.
* Enrolled in our Pancreatic Cancer Registry and Tissue Bank protocol (AAAA-6154).
* Have at least 2 relatives (of whom one must be first-degree relative) with pancreatic cancer, or have been diagnosed with a a genetic syndrome which is associated with pancreatic cancer (among the included syndromes include BRCA1/2, FAMMM, Peutz-Jeghers, HNPCC, Hereditary Pancreatitis) -OR- Have radiological or pathological (fine needle aspirate or surgical biopsy) evidence of local tumor recurrence following surgery.

Exclusion Criteria:

* Metastatic disease discovered at presentation or on recurrence (exception is the familial PDC patients)
* Positive surgical margins.
* Lack of clinical followup at one year following surgery
Treatment of Patients With Major Depressive Disorder With MK0869 (0869-061)

A clinical study to determine the efficacy and safety of an Treatment of MK0869

in the treatment of depression.

The duration of treatment is 8 weeks.

Eligibility Criteria:
Patients with Major Depressive Disorder
Study of Ombitasvir/Paritaprevir/Ritonavir in Japanese Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection With End Stage Renal Disease (ESRD) on Hemodialysis (HD)

The purpose of this multicenter, single-arm, combination-drug study, which includes 12 weeks of treatment and 24 weeks of follow-up, is to evaluate the safety, efficacy and pharmacokinetics of ombitasvir/paritaprevir/ritonavir in Japanese adults infected with HCV GT1b, who are treatment-naïve or treatment-experienced to an IFN-based regimen and who have ESRD on HD.


Eligibility Criteria:
Inclusion Criteria:

* Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
* Hepatitis C Virus (HCV) Ribonucleic acid (RNA) greater than 10,000 IU/mL at Screening
* Chronic HCV, Genotype (GT)1b infection
* Treatment-naive or treatment-experienced with an interferon (IFN)-containing regimen (IFN or pegylated-IFN with or without ribavirin).
* A fibrosis assessment test result equivalent to Metavir F0-F2.

Exclusion Criteria:

* Presence of Y93H variant at Screening
* Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human immunodeficiency virus antibody (HIV Ab)
* Significant liver disease with any cause other than chronic HCV infection
* On peritoneal dialysis
* On hemodialysis for more than 15 years
Absorption of Zinc (Zn) From Zn-biofortified and Zn-fortified Maize in Young Zambian Children Between 24-36 Months

The objective of this study is to compare the quantity of Zn absorbed from an accurately weighed quantity (\~100 g) of minimally milled control maize (\~15 µg Zn/g maize), from biofortified maize (\~30 µg Zn/g) and from the same control maize that has been fortified (total level of \~60 µg Zn/g) when fed to young children age 24-36 months whose major habitual food staple is maize.

Participating children were randomized to receive an accurately weighed quantity of \~100g/day of either the control, fortified or biofortified study maize for 1 day.

On day 1, mothers brought their child to the health center before breakfast. All meals were extrinsically labeled with a zinc stable isotope (70Zn). Meals on this day were consumed in the presence of the research staff. The quantities of nshima or porridge prepared and eaten were accurately weighed and duplicate meals were collected for subsequent mineral analyses.

Between lunch and dinner on day 1 at the Health Center, a blood sample was collected for Hb and plasma Zn analyses and, immediately after and through the same needle, a stable isotope of zinc was intravenously administered into a forearm vein over 1-2 minutes. The family then returned home.

Morning spot urine samples were collected twice daily starting on day 5 and continuing through day 8. Once these collections were finished, the study for this child was complete.

Dietary Zn was measured from laboratory assays of the duplicate test meals. Fractional absorption of Zn (FAZ) was measured by dual isotope tracer ratio methods in urine. Absorbed Zn was calculated by multiplying dietary Zn by FAZ.

Eligibility Criteria:
Inclusion Criteria:

* Children age 24 to 36 months
* Maize meal accounts for at least 75% energy intake
* Able to consume 100 g maize flour/day
* Clinically healthy (stunting is acceptable)
* Lives in target community

Exclusion Criteria:

* Children with chronic or other known chronic disease
* If children are receiving zinc-fortified products, these products will need to be withheld for 2 weeks prior to the study
Taste Assessment Study of SHP429 in Healthy Adult Subjects

The purpose of this study is to compare the palatability of SHP429 capsule contents delivered via 3 means of administration (sprinkled on yogurt, sprinkled on applesauce, and emptied into a cup and administered with water).


Eligibility Criteria:
Inclusion Criteria:

* normal, healthy, adult male and female volunteers, without evidence of active or chronic disease
Pre- and Post-prandial Levels of Appetite Regulatory Hormones in Adults

The present study aims to evaluate in adults with normal weight and with overweight or obesity who live in the city of La Plata the circulating levels of various hormones that regulate appetite and the gene expression of their receptors in peripheral blood mononuclear cells before and after food intake.

the investigators plan a single test meal study in males and females with normal weight (NW) or overweight/obesity (OW/OB) assessing whether plasma appetite regulatory hormones levels are associated with different metabolic and anthropometric variables as well as with appetite sensations.

Eligibility Criteria:
Inclusion Criteria:

* adult individuals body mass index\> 18.5 kg∙m-2

Exclusion Criteria:

* chronic medical illness, personal history of diabetes, history of medical condition, or medication related to obesity or diabetes risk status.

Pregnancy
Imaging of Tumour Microenvironment in Patients With Oropharyngeal Head and Neck Squamous Cell Carcinoma Using RGD PET/CT Imaging

Known risk factors inducing squamous cell carcinomas of the head and neck are tabacco and alcohol intake. However, the incidence of human papillomavirus (HPV) related oropharyngeal carcinomas is increasing. It is known that HPV+ and HPV- tumors have a different reaction to (chemo)radiotherapy. The exact mechanisms underlying these differences is not yet known but might be caused by changes in vascularity. Therefore the vasculature is imaged with the help of a study specific Gallium-68-DOTA-(RGD)2 PET/CT scan and a CT perfusion scan.

The incidence of Human Papilloma Virus positive (HPV+) oropharyngeal Head and Neck Squamous Cell Carcinoma (HNSCC) is rising and it has become evident that this type of cancer represents a subgroup of HNSCC that is characterized by a more favourable prognosis, mediated by a distinct tumour microenvironment, compared to patients with HPV negative (HPV-) tumours. However, the exact mechanisms underlying this improved treatment outcome and the potential role of the tumour microenvironment are not fully understood yet. Imaging of αvβ3 integrin expression will obtain more insight in the differences in tumour microenvironment between HPV+ and HPV- oropharyngeal HNSCC. CT perfusion provides additional characterisation of this tumour microenvironment. Therefore, these techniques may have the potential to predict response to treatment and might possibly steer treatment decisions in future clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Proven squamous cell carcinoma of the oropharynx
* p-16 immunohistochemistry analysis
* Tumour lesion of at least 1.0 cm in diameter
* Planned chemoradiotherapy as primary treatment
* Ability to provide written informed consent

Exclusion Criteria:

* Contra-indications for PET
* Contra-indications for administration of iodine-containing contrast agents
* Other serious illness that can affect the scans