cyrilzakka/clinical-trials huggingface dataset:
Home Semen Testing in Men Beginning Attempts to Conceive

The overall objective of the proposed study is to enhance early detection of male factor infertility and reduce cost and morbidity associated with delayed diagnosis through development of a universal screening model based on home semen testing. The advent of inexpensive and accurate home semen testing has enabled a potential paradigm shift in the approach to male fertility evaluation. The investigator's central hypothesis is that universal home semen testing prior to attempts to conceive is easy for participants and can lead to reduced fertility-related anxiety and early detection of male factor infertility, thereby expediting evaluation and treatment for the couple while minimizing unnecessary cost and morbidity.

This study is specifically designed to assess the feasibility and utility of home semen testing for couples who are beginning attempts to conceive. First, the investigator will assess participants' ability to complete the home semen testing, ease of use, and obstacles encountered in doing so. Second, the investigator will examine the impact of home semen testing in fertility-related quality of life among couples beginning attempts to conceive, as well as ability of home semen testing to increase the diagnosis and treatment of male infertility in these couples.


Eligibility Criteria:
Inclusion Criteria:

* Natal males over the age of 18 with no prior children who are interested in future fertility
* Current female partner
* Not attempting to conceive for more than 3 months
* Willing to sign the Informed Consent Form
* Able to read, understand, and complete patient questionnaires, pain texts, and medication diary.
* Ownership or accessibility of a smart phone or electronic device that is compatible with the YoSperm® device

Exclusion Criteria

* Prior semen testing
* History of male infertility, Klinefelter syndrome, undescended testis, or chemotherapy
* Female partner with history of infertility
* Female partner with irregular menstrual periods
Cyanoacrylate With or Without Suture?

An epithelialized gingival graft will be harvested from the palate for the treatment of various mucogingival deformities. The donor site will be treated with either a combination of a collagen sponge and cyanoacrylate or a collagen sponge, cyanoacrylate, and suspending sutures. Intraoperatively, measurements will be taken for palatal tissue thickness, graft dimensions, working time, and primary bleeding time. Data regarding pain perception will be gauged using a visual analog scale, and the number of analgesics, secondary bleeding, epithelization level, and color match will be assessed prospectively. These outcomes will be evaluated on the first 7 days and subsequently on the 14th, 21st, and 28th days. Patient-reported outcomes will be recorded using the Oral Health Impact Profile-14 questionnaire.


Eligibility Criteria:
Inclusion Criteria: Inclusion Criteria:

* age ≥18;
* mucogingival surgical treatment indication that needs connective tissue graft in the anterior mandible;
* stable periodontium after phase I therapy;
* full-mouth plaque and bleeding scores \<15%

Exclusion Criteria:

* previous palatal harvesting history;
* unstable endodontic conditions;
* tooth mobility at the surgical site;
* systemic disease;
* pregnancy;
* use of medications with potential adverse effects on periodontal tissues
Evaluation of Halitosis After Treatment With Photodynamic Therapy Associated With Periodontal Treatment

The aim of this randomized, controlled clinical trial was to treat oral halitosis in healthy adults with photodynamic therapy associated with periodontal treatment and follow them up for 3 months. The participants with halitosis will be randomized into two groups: G1-treatment with photodynamic therapy or G2-cleaning of the tongue with a tongue scraper . Halitosis were evaluated measuring volatile sulfur compounds using gas chromatography After the treatments, a second evaluation will be performed, along with a microbiological analysis (qPCR) for the identification of the bacteria T. denticola

Halitosis is an unpleasant odor that emanating from the mouth. A recent metanalysis shows worldwide trend towards a rise in halitosis prevalence. Studies show halitosis returns in a week after treatment with photodynamic therapy (PDT). Probably, bacteria residing in the periodontal sulcus could recolonize the dorsum of the tongue. To date, there are no study in adult population that associate halitosis and periodontal treatment with follow-up evaluation. The aim of this randomized, controlled clinical trial was to treat oral halitosis in healthy adults with photodynamic therapy associated with periodontal treatment and follow them up for 3 months. The participants (n=40) with halitosis will be randomized into two groups: G1-treatment with photodynamic therapy (n = 20) or G2-cleaning of the tongue with a tongue scraper (n = 20). Halitosis were evaluated measuring volatile sulfur compounds using gas chromatography After the treatments, a second evaluation will be performed, along with a microbiological analysis (qPCR) for the identification of the bacteria T. denticola. The evaluation of halitosis and the microbiological analysis will be repeated. After that, patients will receive periodontal treatment. The participants will return after 1 week and three months for an additional evaluation. Quality of life will be measured by Oral Health Impact Profile (OHIP-14) Comparisons will be made with ANOVA test, with the level of significance of 5 %. This protocol will determine the effectiveness of phototherapy regarding the reduction of halitosis in adults.

Eligibility Criteria:
Inclusion Criteria:

* Both genders
* with at least 10 teeth
* Periodontal screening and recording (PSR) 0, 1 or 2
* without any changes in the anatomy of the back of the tongue (geographical or fissured tongue)
* positive halitosis (SH2 level higher than 112 ppb).

Exclusion Criteria:

* smokers
* ex-smokers for less than 5 years
* patients with hypersensitivity to the photosensitizer.
Mechanically Optimizing Cardiac Preload in Heart Failure Patients

The purpose of the current study is to determine if partial balloon occlusion of the inferior vena cava can optimize cardiac pre-load and subsequently pulmonary pressures and cardiac output as a novel method to unload pulmonary edema and other symptoms of decompensated congestive heart failure. All products in this study are FDA approved and adhere to the specifications of the intended use.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects scheduled to undergo a right heart catheterization at Saint Thomas Hospital.
2. New York Heart Association (NYHA) II or III.
3. Subjects must be last least 18 years of age.
4. A left ventricular ejection fraction \>= 20%.
5. Pulmonary artery occlusion pressure, or pulmonary wedge pressure \>20 mmHg.

Exclusion Criteria:

1. Subjects without sinus rhythm.
2. Evidence of right heart failure.
3. Patients with primary pulmonary hypertension
4. Pulmonary wedge pressure \<15mmHg.
5. Significant lung disease, such as prior diagnosis of COPD.
6. Resting or dynamic outflow tract gradient
7. Patients with left bundle branch block
Shared Decision Making in Dialysis

Older patients ≥65 years with chronic kidney disease (CKD) face challenges in decision making about dialysis. These patients report little effort by physicians to elicit treatment preferences, discuss prognoses, or explain the burdens/benefits of dialysis options including conservative management. Older patients with CKD often prefer maintaining the quality of life over prolonging life, and many regret their decision to start dialysis: nearly one quarter withdraw from dialysis each year. Shared dialysis decision-making requires active engagement between nephrologists and patients to align patient, caregiver, and physician communication around common goals. The proposed study is a pilot randomized cluster trial of a dialysis shared decision-making (DIAL-SDM) intervention for nephrologists (n=20) and their patients ≥65 years old (n=60) with an estimated glomerular filtration rate (eGFR) of ≤ 20 ml/min/ /1.73 m2. Nephrologists in the Intervention Group will receive 3 communication training sessions, delivered by a standardized patient instructor (SPI) who enact clinical scenarios and offer feedback. In parallel, patients (and caregivers, if available) will receive 2 coaching sessions provided by health coaches, who will explore each patient's relevant contextual information (values, preferences, and goals), and help them identify and practice important questions for their nephrologist. Nephrologists in the Control Group will provide their patients with usual care. The study outcomes will be assessed during two nephrology office visits and at 6 months.


Eligibility Criteria:
Inclusion Criteria:

For nephrologist:

* Member of Strong nephrology group working at Strong Memorial Hospital
* Treat patients with CKD

For patients:

* Age ≥65 years old
* Presence of advanced CKD stage 4 or 5 (i.e. e GFR ≤ 20 ml/min)
* Patient's nephrologist is enrolled in the study, and has seen that nephrologist at least once
* Speaks English
* Have not attended a dialysis education class or met with the dialysis education coordinator.
* Have not made a dialysis decision

For Caregivers:

* Self-identified caregiver (per definition:"family member, partner, friend or someone else who is involved with your health care issues, for example, someone who you talk to about personal issues including medical decisions or who comes to doctor appointments with you. This person may also help with routine day-to-day activities, like transportation or paperwork.")
* 21 years of age or older.

Exclusion Criteria:

For Nephrologists:

- Expecting to leave in six months.

For Patients:

* Patient has already been seen by a palliative care clinician or is enrolled in hospice
* Is already on dialysis
* Hospitalized at the time of recruitment
* Cognitive impairment
* Does not speak English

For Caregivers:

* If Support is offered primarily in a professional role (e.g., clergy).
* Cognitive impairment
Safety Study Looking at the Effects of Stendra on Vision

The purpose of this study is to see if Stendra causes any changes in vision, eye pressure, pupil dilation, and color vision in healthy males.

The objectives of this study are to assess the effect of Stendra on visual acuity, intraocular pressure, pupillometry, and color vision discrimination in healthy male subjects.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males 18 to 45 years of age, inclusive
* Non-tobacco user for at least 6 months prior to first dose

Exclusion Criteria:

* History or presence of retinal disease or any vision defects including color vision
* Intraocular pressure value ≥ 22mm Hg
* Resting heart rate \< 45 or \> 90 beats per minute (3 rechecks)
* Systolic blood pressure \< 90 or \> 140 mm Hg or Diastolic blood pressure \< 50 or \>90 mm Hg (3 rechecks)
* Initiation or change in dose of any α-blockers 14 days prior to randomization
Hepatitis C in Renal Transplant Recipients

The aim of the present trial is to evaluate whether the conversion of immunosuppression from tacrolimus to cyclosporine A induces changes in (i) hepatitis C-virus load, (ii) parameters of hepatic function and (iii) parameters of glucose tolerance in hepatitis C-positive renal transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* prior renal transplantation
* current tacrolimus-based immunosuppressive regimen
* hepatitis C-infection
* age 18-70 years

Exclusion Criteria:

* current hemodialysis or peritoneal dialysis
* pregnancy or breastfeeding
* known contraindication for cyclosporine A-treatment
Distinguishing Non-Specific Low Back Pain from Scoliosis-Related Pain Via Quality of Life Questionnaires

Vertebral deformities, such as scoliosis, can have a significant impact on the physical and psychological health of patients. Over time, specific tools have been developed to investigate the extent of this impact; the SRS-22 (Scoliosis Research Society) questionnaire is the most commonly used instrument for assessing quality of life (QoL) in patients with idiopathic scoliosis. The Oswestry Disability Index (ODI), on the other hand, was developed to evaluate the quality of life in adult patients with chronic non-specific low back pain.

The clinical protocols at our institute involve the regular and continuous evaluation of the quality of life in patients undergoing treatment and monitoring for scoliosis and other vertebral deformities. To this end, the SRS-22 questionnaire and the ODI questionnaire are employed, along with other measures such as the COMI (Core Outcome Measure Index) and ISYQoL (Italian Spine Youth Quality of Life).

The aim of this study is to compare the properties of the ODI with those of the SRS-22 questionnaire in adults, by analyzing differences between individuals with non-specific low back pain and those with scoliosis. The secondary objective involves a sub-analysis based on the severity of scoliosis, dividing curves into major (30° Cobb or higher) and minor (below 30° Cobb). Finally, if sufficient data are available, the study will also evaluate other commonly used questionnaires (COMI and ISYQoL).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Diagnosis of idiopathic or degenerative scoliosis with a curve \>10° Cobb and
* low back pain
* Diagnosis of non-specific low back pain

Exclusion Criteria:

* Previous spinal surgery
* Significant past illnesses, surgeries, or trauma
* Secondary scoliosis
* Other deformities such as spondylolisthesis and spinal canal stenosis
* Incomplete ODI and SRS-22 data
Treatment for Early Memory Loss

The purpose of this study is to evaluate the effectiveness of donepezil (Aricept) for the treatment of mild cognitive impairment (MCI) in elderly adults. This study will also determine whether adding ginkgo biloba extract (GBE) enhances the effects of donepezil.

Cognition involves important thinking processes such as perception, learning, and reasoning. There are currently no definitive treatments for cognitive deterioration. This study focuses on elderly individuals with MCI because people at a pre-dementia stage may sustain the greatest and most lasting benefit from cognitive-enhancing agents.

Patients receive either donepezil or placebo for the first 6 months of the study. In the second 6 months of the study, patients are randomized to receive either donepezil plus GBE or donepezil alone. Positron Emission Tomography (PET), which provides a color-coded image of the brain's blood flow in a particular area, is used to assess brain activity during memory tasks. A PET scan is performed at study entry, 6 months, and 1 year. A vasodilator (a drug that dilates the blood vessels) is administered during the PET imaging procedure to determine whether vascular disease affects memory function. A magnetic resonance imaging (MRI) scan is also taken to view the brain.

Eligibility Criteria:
Inclusion Criteria:

* Display impairment on at least 2 of 3 memory tests
* Meet the following criteria for mild cognitive impairment: subjective complaint of memory problems; no impairment in activities of daily living; general cognitive function in the normal age-adjusted range; abnormal memory function for age; and lacking full DSM criteria for dementia

Exclusion Criteria:

* Have a history of major neurological, metabolic, psychiatric or cardiovascular disease (patients with a history of non-CNS oncologic disease treated surgically and currently in remission will not be excluded)
* Have a cerebrovascular condition
* Abuse alcohol or drugs
* Have renal or hepatic disease, diabetes mellitus, gout, or adrenocortical insufficiency
* Are sensitive to carbonic anhydrase inhibitors, antibacterial sulfonamides, thiazide diuretics, or other sulfonamide-derivative diuretics
* Have taken donepezil or GBE products prior to enrollment
* Have taken medications, including herbal agents (exceptions will be made for routine health maintenance medications such as alendronate \[Fosamax\] for osteoporosis, vitamin therapy \[not to exceed 200 percent RDA for any particular vitamin\], thyroid replacement therapy, hormone replacement, and ophthalmic medications for glaucoma and other eye disorders)
Effect of Sensory Integration Therapy on Balance and Functional Mobility

Purpose: to investigate the effect of sensory integration therapy on balance and functional mobility in children with spastic diplegic cerebral palsy. Methods: children with spastic cerebral palsy, the children were assigned to a control group and a study group. Balance was assessed using the Biodex balance system and functional mobility was assessed using the Timed Up and Go test.

Purpose: to investigate the effect of sensory integration therapy on balance and functional mobility in children with spastic diplegic cerebral palsy. Methods: children with spastic cerebral palsy, the children were assigned to a control group and a study group. Balance was assessed using the Biodex balance system and functional mobility was assessed using the Timed Up and Go test. The control group received selected physical therapy, while the study group received the previously mentioned selected physical therapy program modified to increase sensory input. Treatment sessions for both groups were conducted for both groups for 1 hour once a day, three times per week for two successive months.

Eligibility Criteria:
Inclusion Criteria:

Ages from 6-10 years old. The degree of spasticity was 1 to 1+ Level II according to the Gross motor function classification system

Exclusion Criteria:

Visual or auditory problems. Fixed deformities of lower limbs.
Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH) (IMPACT Trial)

Purpose of this study is to assess the effects of pemvidutide on NASH resolution and NASH fibrosis.

A Phase 2, multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in NASH.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent
2. Male or female 18-75 years
3. Histologic diagnosis of NASH and/or histologic confirmation of NASH based on central pathology evaluation of a liver biopsy during screening

   1. A histologic NAFLD Activity Score (NAS) ≥ 4 with a score of at least 1 on each subcomponent score based on central pathology evaluation (steatosis \[0-3\], lobular inflammation \[0-3\], and hepatocyte ballooning \[0-2\])
   2. NASH fibrosis stages 2 through 3 according to the NASH CRN fibrosis staging system based on central pathology evaluation
4. Subject agrees to have a liver biopsy performed during the screening period (if no biopsy within the preceding 6 months is available) and at 24 weeks of treatment
5. BMI ≥ 27.0 kg/m2
6. Subjects with Type 2 diabetes mellitus (T2D) should be on a stable treatment regimen for their T2D for at least 90 days prior to screening
7. Subject meets at least 3 of the 5 criteria of Metabolic Syndrome (American Heart Association 2005)
8. Liver fat content by MRI-PDFF ≥ 8%

Exclusion Criteria:

1. Weight gain or loss \> 5% in the 3 months prior to randomization or \> 10% in the 6 months prior to screening
2. History or clinical evidence of Type 1 diabetes mellitus
3. Hemoglobin A1c (HbA1c) \> 9.5% or clinically significant persistent hyperglycemia
4. Liver conditions:

   1. History of cirrhosis or complications of cirrhosis, including but not limited to variceal bleeding, encephalopathy, or ascites
   2. Documented causes of chronic liver disease other than NASH
   3. ALT or AST laboratory values \> 5 × ULN
Family Procedural Presence

This study seeks to determine the effect of a quality improvement policy regarding allowing family members to remain in a patient's room during ICU procedures. The investigators hypothesized that our change in policy to invite family members to remain during procedures will improve patient \& family engagement and improve long term psychological outcomes after an ICU admission. The study also seeks to determine if inviting family members to remain in a patient's room during ICU procedures will not increase clinician stress.

This is a research study about the effect of a quality improvement policy change regarding family presence at ICU procedures on family and patient engagement, psychological outcomes and stress levels in clinicians. In the study, ICU patients, their family members and ICU clinicians will be surveyed regarding these outcomes, with some surveys obtained prior to a policy change and a second set during a second time period after policy change. The patients and family members will be asked survey questions after the procedure and 3 months later. This study will also evaluate the change in clinician stress related to this policy change, and clinicians will also answer survey questions.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Able to read \& speak English
* Family member of a patient or a patient that has undergone one of these procedures at any point during the ICU stay (if the procedure occurs from Sunday at 8 am to Friday at 12 pm): intubation, central line placement, arterial line placement, bronchoscopy, thoracentesis, chest tube placement, paracentesis and lumbar puncture
* Physician (both attending physicians and trainees) and nurses who work in the ICU during the study period.

Exclusion Criteria:

* Patients for whom no family member can be identified
* Non-English speaking individuals
* Children (\<18 years of age)
* Participants with dementia, psychiatric disorder with psychosis, schizophrenia or known cognitive dysfunction (established from chart review, report and/or score greater than or equal to 3 on IQ Code screening).
* Provider who does not want to participate