cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of AV608 in Subjects With Idiopathic Detrusor Overactivity

The purpose of this study is to assess the effects of AV608, a neurokinin 1 (NK-1) antagonist, in subjects with Idiopathic Detrusor Overactivity.

This is a Phase 2, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of AV608 in subjects with idiopathic detrusor overactivity. Female subjects between 18 and 65 years of age with a diagnosis of Overactive Bladder Syndrome and urodynamic observation of involuntary detrusor contractions during the filling phase will be eligible for the trial.

Eligible subjects will complete a baseline urodynamic assessment. All subjects who participate in the study will receive 3 weeks of treatment with AV608 or placebo. At the end of the treatment period, subjects will complete a second urodynamic assessment.

Eligibility Criteria:
Inclusion Criteria:

* Female, 18 to 65 years of age, inclusive
* A current primary diagnosis of OAB
* Idiopathic detrusor overactivity, demonstrated by a urodynamic observation
* Evidence of frequency in combination with urinary urgency
* Written informed consent form
* Willingness to avoid pregnancy and practice adequate birth control
* Negative serum pregnancy test
* Agrees to refrain from blood donation during the course of the study

Exclusion Criteria:

* Subjects who are pregnant or lactating
* Clinically significant abnormality or clinically significant unstable medical condition
* QTc interval of 470 msec or greater at Visit 1
* Predominant stress urinary incontinence versus urge urinary incontinence based on subject history
* Neurogenic bladder (e.g. associated with spinal cord injury, multiple sclerosis, etc.)
* Anatomic or structural abnormalities possibly causing urinary incontinence or urgency, including but not limited to urogenital prolapse stage 2 or more according to the Pelvic Organ Prolapse Quantification (POP-Q) system
* Urological or gynecological surgery within 3 months of the baseline urodynamic assessment
* Current UTI or frequent UTIs (i.e., greater than or equal to 4 UTIs per year), interstitial cystitis, hematuria of unknown cause, or use of indwelling catheter
* Electro-stimulation therapy, bladder training, or physiotherapy for bladder control within 2 weeks of Visit 1
* History (within 1 year of Screening) of alcohol or substance dependence (except nicotine dependence) according to DSM-IV-TR criteria
* History of any kind of cancer within the last 2 years
* Existing non-malignant tumors that could compromise the function and/or anatomy of the lower urinary tract
Improving Vaccinations for Young Children (IVY)

The IVY project focuses on improving combination 10 vaccine rates for Tennessee children through an educational and quality improvement intervention rolled out through a stepped-wedge cluster randomized trial.

The proposed work seeks to improve Combination 10 vaccination rates for Tennessee children at 2 years of age through the development and implementation of a new program, Improving Vaccination for Young Children (IVY). Through a collaboration with the Cumberland Pediatrics Foundation (CPF), a non-profit company focused on improving health care services for Tennessee's children, investigators plan to adapt and disseminate existing CoVER educational materials for community pediatric providers and clinical staff, and develop and implement targeted quality improvement (QI) initiatives.

A.3. Specific Objectives:

1. Design interactive web-based modules individualized for two groups (pediatric providers and pediatric clinical staff) to educate on key vaccine topics. Modules will include information related to 1) diseases vaccines are targeting, including influenza 2) vaccine contraindications, common misconceptions, and vaccine safety, 3) communication techniques, 4) vaccine schedules and catch up rules, and 5) exemptions, school requirements, and practice dismissal.
2. Design an in-person QI coaching session incorporating key drivers for improved vaccination rates. The session will be developed using the 4Pillars™ Practice Transformation Program (4Pillars™) and will include introduction of 1) acute visits for vaccine catch up, 2) team-based care practices, 3) standing vaccination record review and vaccination orders, and 4) reminder/recall systems.
3. Implement educational modules and QI coaching session at specific time points within the context of a stepped wedge cluster randomized trial (SW-CRT). Combination 10 \[(Combo 10)\] vaccine rates will be collected monthly from the Electronic Health Record (EHR) of recruited practices for eligible children turning 2 years of age. Vaccine rates will be compared between practices monthly within the SW-CRT design. Rates will also be evaluated by practice over time.

Eligibility Criteria:
Inclusion Criteria:

* pediatric clinics
* serving children at minimum up to age 2
* located in Tennessee

Exclusion Criteria:

-none
Trial for Shoulder Pathology and Pain in Chronic SCI

This research study will investigate in a 12-week home exercise program to see whether it is effective in improving shoulder pathology and reducing shoulder pain in persons with chronic spinal cord injury. The research study will involve ultrasound shoulder examinations of your shoulders using a non-invasive medical ultrasound machine, as well as clinical shoulder examinations and completion of a number of pain questionnaires.


Eligibility Criteria:
Inclusion Criteria:

1. Candidates will be men or women, 18 years of age or older.
2. Candidates must have an SCI and be at least 1 year post-diagnosis
3. Candidates must use a wheelchair (manual or electric) for at least the majority of the time.
4. Candidates must be able to transfer themselves without the help of others.
5. The presence of at least moderate shoulder pain (rating of \>= 4 on a 0-10 rating scale for average pain intensity) for 3 or more months.

Exclusion Criteria:

1. Patients younger than 18 years of age.
2. Patients who have a history of pre-injury rotator cuff tears or shoulder injury.
3. Patients who do not use a wheelchair (manual or electric) at least 50% of the time.
Contagious Misinformation Trial

In the Contagious Misinformation Trial the investigators aim to debunk prevalent misinformation about an infectious disease using two evidence-based methods of debunking. The two debunking methods are packaged in two audio dramas of 4 episodes each, which will be sent to the WhatsApp of participants who are randomised to intervention group 1 or 2. The control group will receive audio messages about a different topic. The primary outcome is the reduction in belief in two misinformation statements about the infectious diseases.


Eligibility Criteria:
Inclusion Criteria:

* Adults
* Living in Freetown
* In possession of a mobile phone that has WhatsApp
* Fluent in Krio

Exclusion Criteria:

* Deafness
LEMTRADA Pregnancy Registry in Multiple Sclerosis

Primary Objective:

The primary goal of this registry is to assess the risk of spontaneous abortion in prospective enrolled women exposed to LEMTRADA for multiple sclerosis.

Secondary Objective:

The secondary goals of this registry is to assess maternal, fetal and infant outcome in women with multiple sclerosis, exposed to LEMTRADA.

From enrollment during pregnancy up to 1 year after delivery for infant follow-up (maximum approximatively 20 months)

Eligibility Criteria:
Inclusion criteria :

* Women with Multiple Sclerosis who were or became pregnant within the period of time between the first infusion of a course of treatment with LEMTRADA to 4 months after their last infusion for that course.
* Women able and willing to provide informed consent for study participation and the requirement of the study. Informed consent will be obtained at the time of enrollment in accordance with local regulatory requirements.

Exclusion criteria:

- Previous enrollment in this study for a previous pregnancy.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Mindful Yoga for Postpartum Depression

This is a parallel-group randomized controlled trial. A total of 198 postpartum women with depressive symptoms (EPDS scores≥8 at baseline) will be recruited and randomized into two groups: 10-week mindful yoga intervention and 10-week psychoeducation program. Clinical assessment of depression, self-report questionnaires and salivary cortisol tests will be performed at baseline, after 10-week intervention, and at 6-month and 12-month follow-ups. The investigators expected that the mindful yoga intervention will reduce depression after 10 weeks compared to psychoeducation. The mindful yoga intervention will further reduce anxiety, stress, improve quality of life and sleep, and steepen diurnal cortisol slopes. These effects will be maintained for at least six months.


Eligibility Criteria:
Inclusion Criteria:

* Postpartum women aged 18-60 years old.
* The scores of EPDS ≥ 10.
* At least 6 week and up to 1 year after childbirth.
* Giving birth to a single full-term healthy baby (gestation between 37-41 weeks, body weight \> 2.5kg, APGAR score at 5 minutes \> 7).
* Fewer than 10 hours of yoga/Qi gong/Tai Chi or mindfulness/meditation practice in the previous 3 months.

Exclusion Criteria:

* Severe complications after delivery, or their infants are admitted to NICU.
* Regular psychiatric follow-up.
* Currently taking antipsychotic drugs.
* Known pragnancy, or other contraindications to physical exercise (e.g., wound healing situation) according to the body examination by O\&G clinicians at 6 weeks after delivery.
Crystalloids Versus Colloids Versus Hypertonic Saline as a Co-load During Spinal Anesthesia.

Spinal anesthesia is commonly accompanied by hypotension due to vasodilation that follows sympathetic blockade and decreased systemic vascular resistance. Prevention of hypotension is usually achieved through administration of fluids and vasopressors .There is an ongoing debate concerning both the proper fluid timing, pre-load against co-load and fluid type crystalloids against colloids .This study aims at comparing the effectiveness of co-loading of crystalloids versus colloids versus hypertonic saline 3% in preventing hypotension induced by spinal anesthesia.

Spinal anesthesia is commonly accompanied by hypotension due to vasodilation that follows sympathetic blockade and decreased systemic vascular resistance. Prevention of hypotension is usually achieved through administration of fluids and vasopressors . Fluids are either administrated before initiation of spinal anesthesia which is defined as fluid pre-loading or at time of initiation of spinal anesthesia which is defined as fluid co-loading .There is an ongoing debate concerning both the proper fluid timing, pre-load against co-load and fluid type crystalloids against colloids. Fluid preloading with colloids appears to have superior effect on that of crystalloids as the later shows a shorter intravascular half-life. While both colloid and crystalloid co-loading show comparable results .Although crystalloid preloading has been the traditional regimen for long time, it failed to reduce the incidence of hypotension. This is because crystalloids rapidly distribute out of the intravascular compartment to the interstitial space. Superiority of fluid co-loading might be explained by decrease of the extravascular crystalloid redistribution secondary to the simultaneous vasodilatation response to sympathetic block.This study aims at comparing the effectiveness of co-loading of crystalloids versus colloids versus hypertonic saline 3% in preventing hypotension induced by spinal anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years
* ASA II-III
* Elective lower abdominal surgeries

Exclusion Criteria:

* Coagulation defects
* Abnormal kidney or liver functions
* Local infection at site of injection
* Uncontrolled hypertension
* Bone metastases
* Cardiac disease
* Elevated serum sodium level \> 145 mEq/L
PET Scan to Map the Areas of the Brain Involved in Planning

Positron Emission Tomography (PET) is a technique used to investigate the functional activity of the brain. The PET technique allows doctors to study the normal processes of the brain (central nervous system) of normal individuals and patients with neurologic illnesses without physical / structural damage to the brain.

When a region of the brain is active, it uses more fuel in the form of oxygen and sugar (glucose). As the brain uses more fuel it produces more waste products, carbon dioxide and water. Blood carries fuel to the brain and waste products away from the brain. As brain activity increases blood flow to and from the area of activity increases also. Knowing these facts, researchers can use radioactive water (H215O) and PET scans to observe what areas of the brain are receiving more blood flow.

This study will attempt to determine the areas of the brain activated by planning processes and decision making. Researchers will ask patients to participate in tests and games (chess) that will stimulate the areas of the brain involved with decision making and planning while undergoing the water PET blood flow technique.

This protocol will attempt to determine the topographical distribution in the brain of the cognitive components of planning using the \[150\] water PET blood flow technique. We will administer perception, motor, simple decision, and planning tasks using the game of chess and the Tower of Hanoi Test as paradigms. Utilizing a "subtraction technique" we hope to identify those areas of cerebral cortex which are most activated by planning processes. It is predicted that the dorsolateral frontal areas will be most prominently activated. It is also predicted that the essential components of the planning process will be the same regardless of the type of plans being executed. The data we collect will be of value in determining 1) the neural representation of planning processes and 2) in guiding cognitive models of the planning system.

Eligibility Criteria:
Normal Controls:

Males and female subjects from two age ranges: 18-30 and 50-65 years of age.

Individuals with a history of neurological or psychiatric disorder will not be included nor will individuals currently taking psychoactive medication.

Patients:

Patients with outstanding problems in planning.

Patients must have a diagnosed CNS disorder with lesion localization verified by MRI scanning available from the referring physician or completed at the NIH Clinical Center.

Patients with unilateral or bilateral lesions that meet the behavioral criteria for selection (planning disorder).

Patients will be medication free (or taking medication with no known central nervous system effects) and be able to understand instructions and task demands.
Effect of Premature Luteinization on the Oocyte Quality in Oocyte Donation Program.

Analyze the possible effect of the progesterone levels of the hCG administration on the oocyte embryo quality. The primary endpoint of this study is the pregnancy rate.


Eligibility Criteria:
Inclusion Criteria:

* Oocyte donors; age range: 18 - 34; BMI: 18 - 29; long protocol.

Exclusion Criteria:

* PCO syndrome;
Ribavirin for Patients With Recurrent/Metastatic (R/M) Human Papillomavirus (HPV)-Related Malignancies

The purpose of this study is to find out the effects, both good and bad, that a drug called ribavirin has on the patient and the cancer.

Ribavirin has also been studied in clinical trials for patients with various types of cancer. These studies demonstrated that ribavirin can be safely given at higher doses than the dosing that is used as part of the treatment of hepatitis C.

Ribavirin is known to target a protein called "4E" that turns on a central part which causes the cell to grow, called the ribosome. HPV-related cancers often have abnormally high levels of 4E. The purpose of this study is to evaluate if ribavirin may be a useful treatment for patients with advanced cancers that are related to HPV by blocking the activity of 4E.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent and/or metastatic HPV-related carcinoma of the cervix, anus, vagina, vulva, penis, or oropharynx. The cancer diagnosis must be confirmed by slide review in the MSKCC Department of Pathology. HPV positive status must be demonstrated by HPV in situ-hybridization (ISH) and/or by p16 immunohistochemistry (IHC).

Note: For cervix squamous cancer, HPV ISH test or p16 IHC test is not required, because all cervix squamous cancers are presumed to be HPV-associated.

* Adults (≥ 18 years of age)
* ECOG performance status of 1 or better
* Measurable disease according to RECIST 1.1 criteria
* Availability of archived tumor tissue for correlative studies (5 unstained slides)
* Adequate organ function, as follows:
* Adequate bone marrow reserve: absolute neutrophil count (ANC) ≥ 1.5 X 109/L, platelets ≥ 160 X 109/L, hemoglobin ≥ 10 g/dL
* Hepatic: total bilirubin within ULN (upper limit of normal); alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.0 X ULN
* Renal: Serum creatinine ≤ 1.3 mg/dL. Patients with serum creatinine \> 1.3 mg/dL may be eligible if creatinine clearance (CrCl) ≥ 55 mL/min based on the standard Cockroft and Gault formula.
* Ability to swallow oral medication.
* Patients of childbearing potential must have a negative serum pregnancy test within 14 days of treatment. Patients must agree to use a reliable method of birth control during and for 6 months following the last dose of study drug.
* At least one prior systemic therapy regimen for R/M HPV-related carcinoma

Exclusion Criteria:

* History of hemolytic anemia or thalassemia
* Current treatment or known prior treatment with ribavirin
* Active infection or serious underlying medical condition that would impair the patient's ability to receive protocol treatment.
* Current therapeutic anticoagulation with Coumadin (warfarin)
* Known brain metastases
Multidimensional Evaluation of Patients' Affected by Obstructive Apnea Syndrome (OSAS) Before and After Ventilotherapy

This observational study aims to evaluate multiple dimensions of health in patients with Obstructive Sleep Apnea Syndrome (OSAS), before and after three weeks of ventilotherapy.

Specifically, the study aims to identify pre- vs post-treatment differences in the following domains:

* cognitive performance
* blood expression of biomarkers related to neurodegeneration
* psychosocial wellbeing

Thus, patients will complete the following evaluations before (T0) and after (T1) ventilotherapy:

* neuropsychological standard assessment
* blood sampling
* psychosocial self-reported questionnaires

Obstructive Sleep Apnea Syndrome is associated with cognitive difficulties, low psychosocial wellbeing and quality of life; however, the possible beneficial contribution of ventilotherapy on these dimensions is not completely clear. Ventilotherapy restores brain oxygenation and improve rest, possibly increasing cognitive performances, psychosocial health and quality of life. Multidisciplinary approaches to the treatment of OSAS are rare, although recommended. Solid proof of OSAS comorbidities may encourage clinicians to adopt a holistic perspective of care, leading to better rehabilitative outcomes. Also, evidence of the beneficial effects of ventilotherapy could increase patients' compliance to ventilotherapy, which is generally low.

The study aims to evaluate multiple dimensions of patient's health before and after three weeks of ventilotherapy, focusing on the cognitive performance, the blood expression of biomarkers related to neurodegeneration, and individual's psychosocial wellbeing.

Overall, it is expected improved cognitive performances and psychosocial wellbeing after ventilotherapy. Also, a reduction in the blood expression of biomarkers related to neurodegeneration (if found before the treatment) is hypothesized, although the limited research in this field requires cautious predictions.

Comprehensive evidence about OSAS comorbidity, beyond breath and sleep difficulties, is mandatory to design innovative multidisciplinary rehabilitative approaches in line with a holistic perspective of care. Effective multidisciplinary approaches are considered the gold standard in medical care, leading to better treatment outcomes and higher patients' satisfaction.

Beyond the clear ethical implication of providing higher quality of treatment, multidisciplinary interventions also imply a shared responsibility of treatment, preventing from clinical misjudgments and professionals' burnout.

Eligibility Criteria:
Inclusion Criteria:

* OSAS diagnosis (AHI \> 5)
* handedness: right

Exclusion Criteria:

* previous ventilotherapy
* neurological and/or neurodegenerative conditions
* Personality disorders, autism spectrum disorders, schizophrenia, psychosis
* sleep disorders comorbidities (eg., narcolepsy)
Influence of the Design of the Transmucosal Abutment on the Periimplant Bone Level

The objective of this study is to evaluate the radiographic changes on the marginal peri-implant bone level on bone level implants with a narrower transmucosal abutment, in comparison to the conventional abutment, both of 3mm height

Patients will receive from one to eight bone-level implants according to their rehabilitation necessity and transmucosal abutments will be connected the day of the surgery. The control group will receive conventional transmucosal abutments while the test group will receive TCP abutments, with a narrower design.

Results will be evaluated initially 6 and 12 months after the connection of the definitive prostheses, and finally 3 years later.

Eligibility Criteria:
Inclusion Criteria:

* Absence of systemic and periodontal pathology, over 18 years of age, with a plaque index below 25%.
* Absence of at least one tooth, with natural adjacent teeth, allowing a prosthetic rehabilitation with an osseointegrated implant and a prosthetic unit.
* Adequate bone quality available, allowing placement of MOZO GRAU® implants InHex STD QUATTRO with diameters of 3.75 mm or 4.25 mm and lengths of 8, 10 and 11.5 mm.
* Natural teeth or implants with fixed restoration as antagonists.

Exclusion Criteria:

* Systemic factors:

  * Continuous administration of systemic medication that can interfere with the bone metabolism or medical conditions requiring prolonged use of steroids and / or medications that can interfere with bone metabolism.
  * History of leukocyte dysfunction and deficiency, immunodeficiency syndromes, kidney failure or bone metabolic disorders, such as osteoporosis.
  * Physical disability that may interfere with proper oral hygiene.
  * Use of any investigational medication or device within the previous 30 days to implant surgery in the study.
  * Alcoholism or drug addiction
  * Smoker of more than 10 cigarettes per day.
  * Conditions or circumstances that could prevent compliance with participation in study or interfere with the analysis of results, such as a history of breach or unreliability.

Local factors:

* History of local radiotherapy.
* Bruxism.
* Diseases that affect the oral mucosa, such as oral lichen planus.
* Untreated periodontitis.
* Persistent intraoral infection.
* Post-extraction alveoli not cured (less than 6 weeks after extraction).