cyrilzakka/clinical-trials huggingface dataset:
A Study of Tadalafil in Men With Benign Prostatic Hyperplasia Symptoms Who Are Being Treated With Alpha Blockers

The purpose of this study is to evaluate the safety and efficacy of tadalafil when given to men who are currently taking a medication called an alpha blocker for the treatment of benign prostatic hyperplasia (BPH) symptoms (such as urinary frequency, urgency, and a feeling that the bladder is not completely emptied after urination).


Eligibility Criteria:
Inclusion Criteria:

* Stable on alpha blocker therapy for the treatment of BPH for at least 4 weeks prior to starting the study.
* Have not taken the following treatments within the indicated duration and agree not to use at any time during the study:

  1. All other Benign Prostatic Hyperplasia therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
  2. Overactive Bladder therapy (including antimuscarinics) for at least 4 weeks prior to receiving study medication.
  3. Erectile Dysfunction therapy (including herbal preparations) for at least 4 weeks prior to receiving study medication.
* If taking finasteride or dutasteride, must have been taking treatment for at least 6 months.

Exclusion Criteria:

* Currently receiving alpha-blocker therapy for the treatment of hypertension.
* History of symptoms associated with orthostasis, including recurrent episodes of dizziness, lightheadedness, loss of consciousness, or syncope.
* Treated with nitrates for any cardiac conditions.
* Have had any of the following in the past 90 days: Heart attack, also known as a myocardial infarction (MI); Heart bypass surgery (called coronary artery bypass graft surgery); Had a procedure to open up blood vessels in the heart known as angioplasty or stent placement (percutaneous coronary intervention).
* Have problems with kidneys, liver, or nervous system
* Have uncontrolled diabetes
* Have prostate cancer, are being treated for cancer or have clinical evidence of prostate cancer (PSA greater than 10 ng/ml at the start of study).
* Have had a stroke or a significant injury to brain or spinal cord.
A Pharmacodynamic and Safety Study of BCS in Healthy Volunteers

To compare pharmacodynamics among the different concentrations of BCS and NS.

2 times mouthwash in the morning and at night. To collect bacterium samples to assess the pharmacodynamics among the different concentrations of BCS and NS: observe the changes of aerobic bacterial colonization in oropharyngeal over time during 24 hours, and assess the improvement of oral healthy status and the subjective feelings after 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, males or females.
* Females with U-HCG negative.
* Signed ICFs, and could conduct this study with investigators.

Exclusion Criteria:

* History of mouthwash allergies, allergic rhinitis or dermatitis.
* Volunteers with oral ulcers, severe periodontal disease, oral mucosal lesions or oral cancer.
* Volunteers with removable denture.
* Had received special oral clean.
A Phase 1b/2 Study of ADG116, ADG116 Combined With Anti-PD-1 Antibody or Anti-CD137 Antibody in Solid Tumors Patients

This is a Phase 1, open-label, dose escalation study in patients with advanced/metastatic solid tumors. Study drug, ADG116, is an anti -CTLA-4 fully human monoclonal antibody that specifically binds to human CTLA-4. ADG106, a fully human ligand-blocking agonistic anti-CD137 IgG4 mAb, is expected to enhance the activity of activated T cells. The enhanced antitumor efficacy results observed from the preclinical studies of ADG116 in combination with ADG106 or anti-PD-1 provided further support to explore such combinations in clinical settings for better patient responses.


Eligibility Criteria:
Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for participation in this study:

1. ≥ 18 years of age at the time of informed consent.
2. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
3. Patients with advanced or metastatic solid tumors, who have progressed after all standard therapies, or for whom no further standard therapy exists.
4. At least 1 measurable lesion at baseline according to the definition of RECIST v1.1.
5. Adequate organ function.

Exclusion Criteria:

• Patients who meet any of the following criteria cannot be enrolled:

1. Pregnant or breastfeeding females.
2. Childbearing potential who does not agree to the use of contraception during the treatment period..
3. Treatment with any investigational drug within washout period.
4. Grade ≥ 3 immune-related AEs (irAEs) or irAE that lead to discontinuation of prior immunotherapy.
5. Central nervous system disease involvement
6. History or risk of autoimmune disease.
7. History of life-threatening hypersensitivity or known to be allergic to protein drugs or recombinant proteins or any ingredients contained in the ADG116 drug formulation.
8. Patients requiring systemic treatment with corticosteroids
9. Patients receiving granulocyte colony stimulating factor (G-CSF), within 14 days prior to the first dose of the study drug.
10. Any uncontrolled active infections requiring systemic antimicrobial treatment (viral, bacterial, or other), or uncontrolled or poorly controlled, asthma, chronic obstructive pulmonary disease (COPD).
11. Major surgery within 4 weeks prior to the first dose of the study drug.
12. Has had an allogeneic tissue/solid organ transplant.
Clinical Significance and Coexistence of Polymorphisms of Individual Collagen-coding Genes

The purpose of this study is to assess correlation between recurrent patella dislocation and genetic polymorphism rs1800012 of the COL1A1 Gene and rs12722 of the COL5A1 Gene.

After being informed about the study and potential risk all of participants were performed phisical examination and genetic test. In the study we established two groups: In first group- 50 patients with recurrent patellar dislocation and without any genetic disorders. In the second one 200 patients without recurrent patellar dislocation and genetic disorders. All pediatric patients were between 7 and 17 years old in two groups respectivly.

Eligibility Criteria:
Inclusion Criteria:

• First-time diagnosed or recurrent patellar dislocation patient from 7 to 17 age years old.

Exclusion Criteria:

* Patient's age under 7.
* Presence of genetic diseases such as: Down's syndrome or Marfan's syndrome.
* Metabolic disorders.
* Previous knee surgeries.
* Cartilage and bone fractures in the knee.
* No consent for examination from the legal guardian.
Flexible Tip Bougie vs Tube With Stylet for Intubation With Videolaryngoscopy.

Although VLs improve glottic visualization, on many occasions it may not be accompanied by intubation at the first attempt, because the endotracheal tube has to pass a sharp angle to enter the trachea. To avoid this limitation, a new flexible tip bougie is designed to flexibly navigate the distal tip and help facilitate precise insertion of the endotracheal tube in the trachea. The flexible tip bougie has an integrated slider along the surface which moves the tip anterior and posterior while the pre-curved distal portion of shaft allows the angulation to provide anterior flexion. This new flexible tip bougie could be used as a rescue when first intubation failure using the videolaryngoscopy, or as a first option to improve the percentage of patients intubated at the first attempt.

The purpose of this prospective randomized study is to compare successful intubation on the first attempt with the new flexible tip bougie versus endotracheal tube with stylet during awake intubation with videolaryngoscopy in patients with anticipated difficult airway.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Patients with anticipated difficult airway requiring intubation under with a videolaryngoscopy
* Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.

Exclusion Criteria:

* Pregnancy
* age \<18 years
* refusal of the patient
* patient's respiratory failure
Mechanisms for Restoration of Hypoglycemia Awareness

To assess if using the hypoglycemic clamp and functional magnetic resonance imaging (fMRI) scanning in hypoglycemia unaware and aware T1DM patients and healthy controls have showed distinct differences in patterns of brain responses. In particular, T1DM patients who are aware of hypoglycemia (T1DM-Aware) have greater activity in sensory integration brain regions (e.g. parietal lobe and caudate nucleus) in response to hypoglycemia, whereas hypoglycemia unaware T1DM patients (T1DM-Unaware) show no detectable changes in brain reward regions during hypoglycemia.

To assess the following: 1) if these differences are driven purely by recurrent hypoglycemia or by other closely linked factors (e.g. glycemic variability); 2) the molecular and metabolic mechanisms by which unawareness leads to the suppression of central nervous system (CNS) activity in the context of hypoglycemia; and 3) whether hypoglycemia avoidance using continuous glucose monitor restores central nervous system (CNS) activation and metabolism toward normal levels and offers a therapeutic approach to more effectively combat neurocognitive dysfunction associated with intensive treatment of T1DM patients.

Eligibility Criteria:
Inclusion Criteria:

* Ages \> 18 years
* Healthy, non-diabetic control or T1DM
* BMI \> 18.0

Exclusion Criteria:

* Creatinine \> 1.5 mg/dL
* Hct \< 35% for females, \< 39% for males
* ALT \> 2.5 X ULN
* untreated thyroid disease
* uncontrolled hypertension
* neurologic disorders
* untreated depression or change in antidepressant regimen in last 3 months
* use of any anxiolytic medications (benzodiazepine) or antipsychotic medications
* greater than 5% change in weight in last 3 months
* malignancy
* current or recent steroid use in last 3 months
* illicit drug use
* significant complications related to diabetes (peripheral neuropathy, proliferative retinopathy)
* inability to enter MRI (per standard MRI safety guidelines)
* for women: pregnancy or breastfeeding
A New Biomarker for the Non-invasive Diagnosis of Rejection After Heart Transplantation

This study is a prospective, observational multi-center cohort study. The study will consist of patients undergoing heart transplantation. The main purpose is to test a new biomarker for rejection against the gold-standard, the endomyocardial biopsy (EMB). 80 patients will be included, both children and adults.

The primary objective is a comparison of an the established, invasive diagnostic test, the endomyocardial biopsy (EMB) against a new, non-invasive test. The new test is the measurement of donor-derived cell-free DNA (dd-cfDNA) circulating in the blood stream of the recipient, quantified by droplet digital PCR (polymerase-chain reaction) after targeted multiplex preamplification. Sensitivity is calculated with EMB as the gold standard. The patients will be followed during one year post-transplantation with simultaneous blood samples and EMB. The patients will further be followed clinically for 5 years. A suitable cut-off for the ratio of dd-cfDNA will be calculated using receiver operating characteristic (ROC) analysis.

Secondary objectives are description of patient outcomes with respect to organ function, quality of life and adverse events.

Secondary objectives are the calculation of the costs related to the transplantation process as well as to the follow-up with EMB. A simulation will be done with respect to possible savings achieved if the new biomarker could be implemented.

The study consists of two cohorts: all adult recipients of heart transplantation at Sahlgrenska University Hospital (one of two center conducting heart transplantation in Sweden): regional study. The other cohort consists of all children undergoing heart transplantation in Sweden:national study. Patients will undergo transplantation at Sahlgrenska University Hospital in Gothenburg as well as at Skåne University Hospital in Lund. Follow-up with blood samples and EMB of these patients will be in Gothenburg, Lund and at Karolinska University Hospital in Stockholm.

Eligibility Criteria:
Inclusion Criteria:

1. Patient on waiting list for heart transplantation
2. Signed informed consent

Exclusion Criteria:

1. Follow-up outside Sweden
Oxidant-antioxidant Activity, Free Radicle Activity, Immune Response and Biomarkers in Extracorporeal Membrane Oxygenation (ECMO) Patients

We would like to investigate novel diagnostic methods or biomarkers to early predict the success of ECMO therapy for cardiogenic shock patients during the early stage after ECMO treatment.

In the investigators previous study (Ann Thorac Surg 2002, 73: 538-545), the investigators knew that for those adult patients receiving ECMO support for post-cardiotomy cardiogenic shock, 1/3 of them would survive to discharge, 1/3 could not be weaned from ECMO and died on the ECMO support, and 1/3 could be weaned from ECMO support, but finally died of multiple organ failure. However, by clinical observation in the first few days of ECMO support, it would be very difficult to predict the outcome of a specified individual patient. Therefore, the investigators usually wait for four to six days to know whether the ECMO treatment is successful or not. If the investigators could predict the result one or two days earlier, this would give physicians enough time to make medical decision. Therefore, the early parameters that could be used to predict the outcome of ECMO treatment would be very valuable. The investigators also found that despite obscure clinical presentation, there was a significant difference in serum cytokines' concentration on the 3rd day of ECMO support between "ECMO successful" and "ECMO failure" patients.

In this study, the investigators will further investigate leukocyte free radical activity, oxidation damage marker (8-OHdG concentration) in serum, whole blood glutathione peroxidase activity for antioxidation, serum IL-6, IL-12, IL-8, IL-10, transforming growth factor-β and other biochemical concentrations and immune cellular changes during the period of ECMO treatment. Patient's blood samples before and 2, 6, 12, 24, 48, 72 hours after ECMO support treatment, at ECMO removal and ICU discharge will be collected and used for the study. The measured factors and the final outcome will be compared. The investigators hope to find early factors change during ECMO treatment among biochemical, immunological and clinical parameters.

Eligibility Criteria:
Inclusion Criteria:

* 1. ≧ 18 yr. 2. cardiogenic shock, needing ECMO support

Exclusion Criteria:

* 1. pre-existing sepsis 2. pre-existing chronic renal failure (dialysis dependent), liver failure, multiple organ failure
Intensity of Physical Activity Measured by Activity Monitors in Elderly Persons

Aim of this study is to identify intensity cut off points for physical activity in a population over the age of 70.

Activity monitors measure activity in counts. The higher the counts, the higher the intensity of the measured activity. In this study the count cut off points for low, moderate and high intensity activity will be investigated in a population of elderly people over the age of 70. This information will subsequently (in future studies) be used to investigate the physical activity patterns in a population of elderly over the age of 70 who have worn an activity monitor for a duration of 7 days.

Eligibility Criteria:
Inclusion Criteria:

* ability to walk at least 1km,
* born in 1938,1939,1940,1941 or 1942
* Sufficiently good health to be able to take part in the study, as determined by the researchers

Exclusion Criteria:

* Illness or disability that precludes exercise or hinders completion of the study
* Uncontrolled hypertension
* Symptomatic valve disease
* hyper tropic cardio-myopathy
* unstable angina
* Active cancer
* Test results indicating that study participation is unsafe
* Inclusion in other studies conflicting with participation in this one
Electrical Impedance Tomography for Optimization of Positive End-Expiratory Pressure: Acute Respiratory Distress Syndrome

Doctors follow a standard ventilator management strategy when making adjustments to the breathing machine to optimize the amount of oxygen into the lungs. The purpose of this study is to assess whether the EIT (electrical impedance tomography) device can be an additional useful tool for ventilator management and identifying the ideal positive end-expiratory pressure (PEEP).


Eligibility Criteria:
Inclusion Criteria:

* Endotracheal ventilation for \< 1 week (168 hours)
* Presence of all of the following conditions for \< 48 hours i. Partial pressure of oxygen to percentage of inspired oxygen (PaO2/FiO2) \< 150 with PEEP \> 5 cm water for \> 30 min.

ii. bilateral opacities not fully explained by effusions, lobar/lung collapse, or nodules iii. respiratory failure not fully explained by cardiac failure or fluid overload

-All criteria listed in (3) developed within 1 week of a known clinical insult or new or worsening respiratory symptoms

Exclusion Criteria:

* Lack of informed consent
* Known pregnancy
* Extracorporeal membrane oxygenation (ECMO) use
* Severe chronic respiratory disease requiring home oxygen therapy or ventilation
* Calculated BMI of greater than 50
An Exploratory Study to Evaluate the Safety of Brimonidine Intravitreal Implant in Patients With Retinitis Pigmentosa

This exploratory, 12-month, ascending-dose study will evaluate the safety and effects on visual function of a single injection of Brimonidine intravitreal implant in one eye of patients with Retinitis Pigmentosa.


Eligibility Criteria:
Inclusion Criteria:

* Retinitis Pigmentosa in both eyes
* Visual acuity between 20/40 to count fingers

Exclusion Criteria:

* Growth of new blood vessels in the eye
* Any intraocular surgery or laser in either eye in the last 6 months prior to Screening visit or between the Screening visit and Day 1
* Any ocular disease that can interfere with diagnosis and or assessment of disease progression
* Significant near-sightedness
* HIV
* Female patients who are pregnant, nursing, or planning pregnancy
Rationalisation of Polypharmacy by the RASP-instrument and Discharge Counselling of Geriatric Inpatients

Systematic evaluation of polypharmacy in geriatric patients, through a validated list by a clinical pharmacist. The goal is reduction of potentially inappropriate medications (PIMs). A brief counseling session with the patient and/or his/her caregiver will be part of the intervention.

This project is focused on the systematic evaluation of polypharmacy in older patients admitted to the acute geriatric wards of a university hospital. Polypharmacy will be identified through a validated list by a clinical pharmacist. The goal is reduction of potentially inappropriate medications (PIMs). Before hospital discharge the hospital pharmacist will have a brief counseling session with the patient and/or his/her caregiver in order to discuss the medication list and to enhance compliance.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent by the patient and/or his/her caregiver
* Admission through the emergency department of patients coming from home or a residential care facility

Exclusion Criteria:

* Patients not speaking Dutch
* Patients admitted for end of life care
* Patients not taking any drugs on admission
Study to Determine if There Are Specific Clinical Factors to Determine Stent Encrustation

Ureteral stent placement is one of the most common procedures performed within urology. The stents are generally placed for relief of obstruction or to prevent obstruction following a urological procedure. Most patients with ureteral stents will eventually form stent encrustations. However, patients form these encrustations at dramatically different degrees and rates ranging from no encrustation at 1 year of stenting to severe encrustation in just a few weeks. The purpose of this study is to determine if the degree of encrustation on a stent for any given patient can be predicted based on 24 hour urine parameters prior to stent placement, with the stent in place and after stent removal.

Patients who will be receiving stents for other urological reasons will have a 24 hour urine sample collected before stent placement, while the stent is in place and after the stent has been removed. The parameters examined in the 24 hour urine collected will then be compared to the amount of encrustation there is on the stent to see if there is any correlation between the two.


Eligibility Criteria:
Inclusion Criteria:

* Patient at UCI
* Scheduled to undergo surgery (standard of care) where ureteral stent will be placed

Exclusion Criteria:

* minors
Oral Health for Healthy Cognitive Aging

Oral health is a critical factor of systemic health, although usually forgotten. A potential relation between cognitive deficits and oral diseases has been suggested. Adult cognitive dysfunctions have a high impact, not only economic, but social and in the family environment. Based on anatomical connectivity between the oral cavity and the central nervous system, the proposed study hypothesizes that masticatory function is a relevant determinant of human cognitive health. The restoration of canonical masticatory function and masticatory training could help to delay the development of such conditions. This project will also test if restoring phasic masticatory function improves the execution of cognitive tasks.

Objective 1: To determine volumetric and anatomical changes of subcortical structures and cortical areas involved in the masticatory circuit and superior cognitive functions.

Objective 2: To determine the functional and brain connectivity changes associated with malocclusion and oral health.

Objective 3: To correlate the anatomic and functional changes associated with malocclusion and oral health with the performance of cognitive tasks representative of those executed in daily life.

Eligibility Criteria:
Inclusion Criteria:

* For Dental occlusion restoration groups: Need of, at least, two molar teeth replacement in the same quadrant.
* For Orthodontic treatment of malocclusion groups: Class I, II or III malocclusion.

Exclusion Criteria:

* Psychoactive drug.
* Central nervous system depressor.
* Patients not willing or not able to consent.
Regional Anesthesia for Knee Prothesis Surgery

Comparison of the analgesics blocks (femoral, adductor canal and sciatic subgluteal nerve) for total replacement knee surgery.

Adductor canal block shows a beneficial effect for knee surgery. Mainly because he prevent for muscular weakness; adverse effect meet with femoral block and delaying the early active mobilization.

The investigators want to compare the efficacy and safety of this block compared to the femoral and sciatic block.

Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for total knee replacement surgery.

Exclusion Criteria:

* refusal to study,
* coagulation disorder,
* infection at the puncture site,
* preexisting neuropathy,
* allergy to local anesthetics,
* renal or hepatocellular insufficiency,
* context of chronic pain,
* drugs abuse,
* pregnant patient.