cyrilzakka/clinical-trials huggingface dataset:
A Phase I/II Trial of AEZS-108 in Urothelial Cancer Patients Who Failed Platinum-chemotherapy

The purpose of this study is to determine the appropriate dose of AEZS-108 to treat patients with a tumor of the urinary system.

AEZS-108 is an investigational drug, combining luteinizing hormone-releasing hormone (LHRH), an hormone and doxorubicin (a drug approved to treat different types of cancer).

Some tumors, such as those found in the urinary system (also called urothelial carcinomas), have LHRH hormone receptors to which the LHRH hormone part of AEZS-108 is attracted.

AEZS-108 is expected to work by accumulating mostly on the surface of cancer cells that have LHRH hormone receptors and by delivering doxorubicin more directly into the cells to kill them. This would allow the use doxorubicin at lower doses and thus would cause less toxicity.

In the first part of the study, the appropriate dose of AEZS-108 will be determined based on its side effects. The best dose will be the highest one without severe side effects.

In the second part of the study, this best dose of AEZS-108 will be given to determine its efficacy to stop the tumor from progressing.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed locally advanced or metastatic urothelial carcinoma
* Expression of LHRH receptors confirmed by immunohistochemistry on archival cancer tissue
* Measurable disease on radiological studies
* Patients with Locally advanced unresectable or metastatic urothelial carcinoma
* Documented progression on at least one prior chemotherapy regimen which must have incorporated platinum based therapy
* Left ventricular ejection fraction (EF) \> 50%
* Eastern cooperative oncology group (ECOG) status of 0, 1 or 2
* Adequate bone marrow, renal and hepatic function

Exclusion Criteria:

* Prior treatment with or allergy to any components of AEZS-108
* Active second malignancies other than non-melanoma skin cancers
* Ongoing use of an LHRH agonist (or antagonist)
* Presence of an active infection or fever \> 38.5 C, parenchymal brain metastases or uncontrolled intercurrent illness
* Prior exposure to anthracyclines or anthracenediones including doxorubicin, daunorubicin, and mitoxantrone
* Patients who received radiotherapy within 4 weeks of entry
* Major surgery within the last 4 weeks and minor surgery in last 7 days
Feasibility Study of the Treatment of Acute Ischemic Stroke Using the NOVIS Transcarotid Neuroprotection System

Study Objective is to establish the feasibility and safety of the NOVIS Transcarotid Neuroprotection System when used for the transcarotid intervention of patients that have a failed transfemoral endovascular therapy in the case of anterior circulation strokes due to large vessel embolic occlusions.

This is a prospective, multi-center, single arm feasibility study for the endovascular treatment of patients with acute ischemic anterior circulation strokes due to large vessel embolic occlusions using the transcarotid approach with flow reversal. Patients enrolled into the NITE 1 Study will have failed transfemoral therapy and will be followed immediately from post-op to 90 days.

Eligibility Criteria:
Inclusion Criteria Summary:

* 1. Patients presenting with acute ischemic stroke of the anterior circulation with large vessel occlusions who are eligible for revascularization using endovascular therapies (stentrievers and/or aspiration devices)

  2. Occlusion of the intracranial ICA, MCA M1, proximal MCA M2, single-vessel MCA M2, dominant MCA M2, or co-dominant MCA M2 segments

  3. Patient has failed transfemoral therapy (see Appendix 4 for definition), and at least 15 minutes have elapsed from groin puncture

Exclusion Criteria Summary:

* 1. Significant disease of the ipsilateral common carotid artery on routine CTA

  2. Presence of a cervical ICA loop or other high-risk anatomical features of the ICA on routine CTA, that may preclude the use of the NOVIS NPS

  3. Any active or recent hemorrhage within the past 30 days

  4. Embolectomy contraindications

  a. Pre-stroke mRS ≥2 b. NIHSS ≤ 5 c. ASPECTS ≤ 5

  5. IV tPA has been or is being administered

  6. Last known well \> 24 hours ago
Clinical-pathological Characterization and Outcomes of Renal Cell Carcinoma in Latin American

Observational study, retrospective and prospective, of an analytical nature. Data will be collected from medical records and/or through contact with physicians and institutions (secondary data collection). Patients included retrospectively or prospectively will be followed during the data collection period for the evaluation of treatments and survival. No intervention is planned in this protocol.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years of age;
* Proven histology of renal cell carcinoma (any subtype);
* Pathological diagnosis of renal cell carcinoma in January 2015 or later and new cases diagnosed during the period of recruitment of each center;
* Have the medical record available and suitable for collecting data on patient characteristics, treatment and outcome.

Exclusion Criteria:

* Synchronous or other primary tumor within the last 3 years (except thyroid cancer or non melanoma skin).
Investigation of an Adaptive Treatment Algorithm for Post-op Thoracic Patients to Reduce the Length of Drainage

The purpose of this study is to reduce the length of drainage using a treatment protocol to control the manipulation of the applied vacuum to the pleural cavity.

In this prospective study, a treatment algorithm is tested in a subgroup of patients with postoperative pulmo-pleural fistula. The primary aim is to reduce the duration of pulmo-pleural fistulation. Secondary aim is to reduce the duration of chest tube therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a post operative air leak after 16 to 24 hours bigger than 50ml/min.

Exclusion Criteria:

* Patients with an empyema
* Patients with a spontaneous pneumothorax
HPV Screening (Human Papilloma Virus)

Examination of cervical \&urine samples for HPV

500 females attending colposcopy kasrelaini unit are included. History including age and parity is taken.urine samples are taken. Colposcopy will be done. Pap smear will be taken and sent for pathology.

Eligibility Criteria:
Inclusion Criteria:

* all females attending colposcopy kasrelaini unit aging 18_45 years

Exclusion Criteria:

* females with known cervical cancer
* females less than 18 or more than 45
PUMP STUDY MDI Lantus/Lispro vs Continuous Insulin+Lispro

Whether a once-daily basal injection of insulin glargine with mealtime injections of insulin lispro achieves equivalent glycaemic control (HbA1c) to administration of insulin lispro by continuous subcutaneous insulin infusion in Type 1 diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of type 1 diabetes mellitus for at least one year.
* Subjects with no previous experience with Continuous Subcutaneous Insulin Infusion (CSII) or insulin glargine,
* capable of managing a basal-bolus regimen and meeting glycaemic targets in accordance with the protocol.
* HbA1c \> than or = to 6.5 \< than or = to 9.0% at screening visit with evidence of lack of insulin secretion (e.g. fasting C-peptide concentration is \< 0.1 nmol/l with fasting blood glucose(FBG) \> 126 mg/dl).

Exclusion Criteria:

* Previous therapy using insulin glargine or continuous subcutaneous insulin infusion.
* Lipodystrophy preventing adequate use of CSII.
* Unwilling or unlikely to be able to use MiniMedr insulin pump with insulin lispro for CSII.
* Unwilling or unlikely to be able to use an MDI regimen with insulin glargine and insulin lispro in accordance with the protocol (for instance, subjects who routinely use a twice-daily mixed insulin regimen should not be included).
* History of more than two severe hypoglycaemic episodes in the past 6 months.
* Acute infection which, in the opinion of the investigator, could lead to increased insulin resistance.
* Acute or chronic metabolic acidosis.
* Episode of DKA (diabetic ketoacidosis) within the last three months.
* Active, uncontrolled, advanced diabetic retinopathy.
* Impaired hepatic function, as shown by \> 2.5 times the upper limit of normal range for AST.
* Impaired renal function, as shown by serum creatinine \> 1.5mg/dl.
* History of gastroparesis. Congestive heart failure requiring ongoing pharmacological treatment.
* Stroke, myocardial infarction (MI), coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) or angina pectoris within the last 12 months.
* Treatment with a non-selective beta blocker.
* Treatment with inhaled or systemic steroids.
* History of hypersensitivity to insulin lispro or to any drug with a similar chemical structure to insulin glargine or insulin lispro or to any of the excipients of the insulin glargine and insulin lispro preparations used in the study.
* Any malignancy within the last five years, except adequately treated basal cell carcinoma.
* History within the last two years or current addiction to substances of abuse including ethanol.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sleep Application Diary and Sleep Hygiene in Adolescents

The purpose of this study will be to see if adolescents can advance bedtime above what can be accomplished by counseling alone simply by inputting their information into a sleep application diary and reporting this information back to their sleep doctor.

Using a smart phone application, participants will record bedtime and wake up times as well as answer questions about their sleep throughout their participation in this study . Reaction time will also be measured through a smart phone application.

Eligibility Criteria:
Inclusion Criteria:

* Males \& Females age 12-17
* have access to a smart phone (iphone or android)
* present to a sleep disorder clinic with poor sleep hygiene and seen by a pediatric sleep specialist

Exclusion Criteria:

* significant developmental delays
* English is not the primary language spoken
Efficacy and Patient Satisfaction of Miralax and Gatorade Versus Movi Prep

This study will be comparing patient satisfaction, efficacy comparing miralax with gatorade versus Movi Prep for outpatient colonoscopy.

Study is the purpose of evaluating patient satisfaction and at the same time efficacy of the bowel regimen in cleansing the colon

Eligibility Criteria:
Inclusion Criteria:

* outpatient colonoscopy for screening for other Gi related problems

Exclusion Criteria:

* Severe Congestive Heart Failure (CHF),
* Chronic Kidney Disease (CKD),
* less than age 18 or more than 80 years
Armodafinil Treatment as Adjunctive Therapy in Adults With Major Depression Associated With Bipolar I Disorder

The primary objective of the study is to determine if armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy for adults who are experiencing a major depressive episode associated with Bipolar I Disorder and who are inadequately responsive to their current treatment for a current major depressive episode.


Eligibility Criteria:
Key Inclusion Criteria:

* The patient has a diagnosis of Bipolar I Disorder and is currently experiencing a major depressive episode.
* The patient is currently being treated with 1 or 2 of the following drugs: lithium, olanzapine, or valproic acid.

Key Exclusion Criteria:

* The patient has any Axis I disorder apart from Bipolar I Disorder that was the primary focus of treatment within 6 months before the screening visit (with the exception of nicotine dependence).
* The patient has any clinically significant uncontrolled medical or surgical condition.
* The patient has previously received modafinil or armodafinil, or the patient has a known sensitivity to any ingredients in the study drug tablets.
* The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
Virtual Body Project Groups Led by Peers Versus Clinicians

Eating disorders (EDs) are a group of illnesses associated with significant psychological and physiological consequences. Overall, only 20% of individuals with EDs receive treatment and treatment is effective for only about 25-35% for those who receive care. The development and implementation of effective prevention approaches for those at risk is therefore pivotal. The Body Project is the most effective ED prevention program for at-risk females according to meta-analyses, but reach has been limited since delivery has traditionally been in-person. Further research is warranted to examine cost-effective and easily accessible approaches to increase scalability and potential for broad implementation. With this application, the investigators therefore propose to examine the effectiveness of the Body Project in young females, a high-risk group, with the following main novel aspects: i) virtually-delivered Body Project groups to maximize reach; ii) peer-led versus clinician-led virtually-delivered Body Project groups; iii) the inclusion of objective measures to assess engagement of intervention targets (i.e., mediator).


Eligibility Criteria:
Inclusion Criteria:

* Age 16-25
* Female identifying
* Self-reported body image concerns

Exclusion Criteria:

* Ongoing eating disorder diagnosis requiring treatment or hospitalization
The Effect On Self-Care and Self-Efficacy of Inhaler Training in COPD

This study aims to evaluate the effect of planned inhaler medication training on self-care agency and self-efficacy level.

Pulmonary diseases are a major source of mortality and morbidity globally. The major symptom of COPD is dyspnea. Since dyspnea leads to activity limitation and inadequate self-care skills among individuals, it is often associated with major psychological comorbidity, social isolation and poor perceived quality of life. COPD patients with high self-efficacy are high enough to level of treatment adherence. On the other hand, the most preferred treatment method for the management and mitigation of COPD symptoms is by the use of inhaler medication. However, incorrect use of the inhaler would lead to failure in the control of COPD patients. Also, it fails to provide COPD patients with self-care agency and self-efficacy levels. In COPD, planned inhaler medication training has been shown in many studies to reduce dyspnoea, increase self-care and self-efficacy levels. Therefore, planned inhaler medication training increases quality of life in COPD patients.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who are literate,
* Diagnosed with COPD at least six months ago,
* Using inhaler medication since three or more months,
* Moderate or severe COPD, according to GOLD criteria,
* Incorrect use inhaler medication uses according to the list of inhaler medication use skills,
* No communication problems,
* No mental confusion or any psychiatric problem,
* Agrees to participate in the study.

Exclusion Criteria:

* Cognitive dysfunction,
* Severe pulmonary, cardiological or malignant disease,
* In a period of exacerbation,
* Correctly performs all steps for their prescribed inhaler medication(s), according to the list of inhaler skills.
Evaluation of a New Local Drug Delivery in the Nonsurgical Treatment of Periodontitis

The aim of the planned randomized clinical trial will be the clinical and microbiological evaluation of the new intracellular drug developed in cooperation with the Chair and Department of Drug Form Technology of the Medical University and the Department and Department of Pharmaceutical Microbiology and Parasitology of the Medical University in Wrocław.

Clinical trials will be conducted on 60 patients of the Department of Periodontology of the Medical University of Wrocław with 3rd or 4th degree generalized periodontitis, who will consent to participate in the research by signing the documentation approved by the Bioethics Committee of our University. The exclusion criteria will be: the presence of general diseases affecting the clinical condition of the periodontium, hypersensitivity to the drug used in the carrier system, lack of proper oral hygiene, active nicotinism and age over 65 years. The research will be carried out according to the scheme of parallel randomization and double-blinded trial in two groups of 30 people. All qualified patients will undergo an initial period of periodontal treatment and scaling / root planning.

In the first group, on one side of the dental arch, the drug under evaluation will be used, and on the other side, placebo with a change of side in every second patient. In the other group, the drug under evaluation or placebo will be used on one side, and the SRP treatment with alternation of sides on the other side for every second patient.

Eligibility Criteria:
Inclusion Criteria:

* stage- 3rd degree generalized periodontitis
* stage 4th degree generalized periodontitis

Exclusion Criteria:

* presence of general diseases affecting the clinical condition of the periodontium,
* hypersensitivity to the drug used in the carrier system,
* lack of proper oral hygiene
* active nicotinism
* age over 65 years
A Validation Study of Mobile Virtual Reality-Based Self-Care and Exposure Therapy Contents for the Treatment of Panic Disorder

The purpose of this study is to determine whether mobile-based virtual reality exposure treatement can reduce the symptoms of panic disorder and the symptoms of depression and anxiety than the waitlist group


Eligibility Criteria:
Inclusion Criteria:

- Meet Diagnostic Statistical Manual criteria for panic disorder(with or without agoraphobia) .

No change in drug dosage during the study period

Exclusion Criteria:

- Patients with a history of major neurological or significant medical illness, or met the diagnostic criteria of current substance misuse
Treatment Decision Intervention for Veterans With Prostate Cancer

Newly diagnosed localized prostate cancer patients face difficult decisions about treatment and management; including radiation therapy, radical prostatectomy, brachytherapy, and observation. Previous studies have cited patient preference and physician recommendation for treatment as major roles in treatment decisions.

Background:

Newly diagnosed localized prostate cancer patients face difficult decisions about treatment and management; including radiation therapy, radical prostatectomy, brachytherapy, and observation. Previous studies have cited patient preference and physician recommendation for treatment as major roles in treatment decisions.

Objectives:

This grant will be used to develop and evaluate a decision analysis based intervention to improve decision-making among veterans with newly diagnosed localized prostate cancer. While the ultimate goal of this study is to improve decision-making among these patients, factors influencing physician recommendations for treatment will be sought. The former will be achieved by evaluating the efficacy of providing physicians with information incorporating patient preference for alternative health states with probabilities of treatment outcomes. Factors influencing physician recommendations for treatment will be determined through qualitative interviews with physicians.

Methods:

Patients were accrued at the VA Chicago Health Care System Lakeside Urology Clinic. Upon consent for participation in the study, comorbidities, histologic grade of the biopsy, and age were obtained for 13 patients with newly diagnosed localized prostate cancer. Using a standard gamble technique, interviewers obtained patient utilities for 5 distinct health states related to prostate cancer treatment. Clinical and pathologic characteristics were incorporated into the decision analytic model, and the derived quality-adjusted life expectancies (QALEs) were shared with the treating urologist before patient-physician discussion of treatment options. The feasibility of the decision analytic intervention and unbiased estimates of the impact of the intervention was evaluated. The long-range objective of this proposal is to design an intervention for veterans that increases physician understanding of patient treatment preferences and patient understanding of choices in prostate cancer treatment.

Status:

Completed

Eligibility Criteria:
Inclusion Criteria:

1) biopsy confirmed diagnosis of localized prostate cancer; 2) newly diagnosed-no prior treatment (including watchful waiting) or discussion with their prior physicians about treatment options; 3) no previous neoplasms in the last five years, with the exception of basal cell cancer of the skin; 4) speak english; 5) no major psychiatric disorder that would preclude their participation; 6) be between 50 and 80 years of age.

Exclusion Criteria:
Effects of Visual Art Training on Dementia

The purpose of the proposed study is to better understand what benefits visual art has on reducing problematic symptoms in dementia patients, including those with Alzheimer's disease.

Participants:

Participants will be residents, attendees and/or members of assisted living locations and/or dementia (or related) day programs. There will be two groups: an art training group and a waitlist control group.

Data Analysis:

1. For primary measures, t-tests on pre-post difference scores comparing art training and waitlist groups.
2. For possible confounding effects, tests for confounds related to background factors (socioeconomic status, education level, gender, activity participation).

Procedure:

A randomized controlled trial design will be utilized to assess two groups of dementia patients: an art training experimental group and a structured usual-activity waitlist control group. The experimental group will participate in a visual art training program and the waitlist control group will participate in their usual structured group activities. The waitlist control group will receive the art training program once post-testing is complete. Before, during, and/or after the art programs and/or control activities, participants will be observed and complete assessments.

Eligibility Criteria:
Inclusion Criteria:

* Dementia

Exclusion Criteria:

* Inability to participate in the art training program due to physical or cognitive limitations
The Role of Oxytocin in Regulating Blood Glucose

Investigating the effect of oxytocin on pancreatic endocrine functions by determining insulin and glucagon secretion within physiological ranges of plasma glucose.

Insulinotropic effects of oxytocin will be examined in 20 healthy men with body mass index (BMI) \< 27 kg/m2, during a graded glucose infusion test with concomitant intravenous infusion of synthetic oxytocin or placebo in a randomized, double-blinded design. This will determine the effect of oxytocin on glucose-stimulated insulin and glucagon secretion. Additional changes in plasma/serum concentrations of C-peptide, glucose, glucose-dependent insulinotropic polypeptid (GIP), glucagon-like peptide 1 (GLP-1), and lipids will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* BMI 19-25 kg/m2

Exclusion Criteria:

* Diabetes
* Heart-, liver or kidney disease
* More than 14 units of alcohol weekly, or drug abuse
* Smoking or any kind of nicotine products
* Alanin aminotransferase (ALAT) ≥ 2 × normal range
* Estimated glomerular filtration rate (eGFR) \< 60 ml/min/1,73m2 or creatinine above normal range
* Blood pressure \> 140/90
* Hemoglobin \< normal range
* Corrected QT Interval (Qtc) \>0,45 sec. at electrocardiogram (ECG) at screening
* Known disease in the pituitary gland or previous pituitary surgery
* Any other disease/condition which the trial managers believe may affect participation in the trial