cyrilzakka/clinical-trials huggingface dataset:
Study to Assess the Longterm Safety of Sildenafil Citrate in Patients With Pulmonary Arterial Hypertension

Open label extension study to the pivotal efficacy study to assess the safety of sildenafil citrate in patients with pulmonary arterial hypertension


Eligibility Criteria:
Inclusion Criteria:

* Patients with PAH who had completed the 12 week pivotal study

Exclusion Criteria:

* Any other patients with PAH that had not been included into the pivotal study
The Influence of the Menstrual Cycle on Lithium and Sertraline Blood Levels

The aim of this study is to determine whether blood levels of lithium or sertraline are affected by different phases of the menstrual cycle and whether there is an effect on psychiatric symptoms. Subjects are seen for two visits: one visit during the luteal phase and one visit during the follicular phase of the menstrual cycle. On each visit, they will fill out a depression, anxiety and mania rating scale. Also at each visit a 20mL blood sample will be drawn to measure progesterone level and either a lithium or sertraline level, depending on which medication the patient takes. The primary hypothesis in this study is that blood levels of lithium and sertraline will be significantly lower in women during the luteal phase of the menstrual cycle than during the follicular phase. Examination will also be made of whether symptoms will increase in severity during the luteal phase as compared to the follicular phase. The investigators expect a negative linear association between symptom severity and blood level, i.e. expect symptom severity to worsen as blood levels of lithium or sertraline decrease.


Eligibility Criteria:
Inclusion Criteria:

* 18-40 year old female
* women currently taking Lithium or Sertraline

Exclusion Criteria:

* currently pregnant or breastfeeding
* concurrent use of any form of hormonal birth control, including oral contraceptive pills, Norplant or Depo-provera
* hepatic or renal disease
* irregular menstrual cycles.
Return to Work and QOL Following TBI. Impact of Rehabilitation Service.

The proportion of patients who return to work after surviving severe traumatic brain injury (TBI) has been estimated in number of studies but results do not agree.This may be due to complex interaction between many factors, including available rehabilitation services.

In Denmark rehabilitation services vary been regions and municipalities. Hospital based rehabilitation is organized by the regions. Rehabilitation outside the hospitals is organized by the municipalities

The first purpose of this study is to investigate a possible link between centralized hospital based rehabilitation and better return to work / quality of life.

The second purpose is to investigate whether municipality size affects quality of life and return to work after severe TBI.

Data on return to work are derived from a national register on labor market attachment. Data on quality of life are derived from a questionnaire.

The study population is identified from the Danish Head Trauma Database. The completeness and accuracy of the database will be investigated as the first part of the project.


Eligibility Criteria:
Inclusion Criteria:

* age 18-64

Exclusion Criteria:

-
Reassure Device: Measurement Accuracy of Continuous Respiration Rate

The aim of the trial is to prove that the Reassure10.5 GHz sensor is equivalent in performance to the SomnoScreen Plus RC in indicating the breathing rate of adult subjects over a number of hours when the subjects are lying still or in bed asleep

Each recording comprised at least 2 hours duration. The subject was lying on a bed, wearing the SomnoScreen and with the Reassure on a bed-side table in the recommended position: at arm's length, pointing at the subject's upper torso.

The subject was asked to lie in set positions on the bed for 20 minutes at a time. The data was recorded continuously for the duration of the trial and so encompassed the acts of turning from one position to another and any minor movement made by the subject. If the subject fell asleep during the trial, they were only woken when it came time for the next position change.

Key Duration Remarks Supine \>=20minutes Subject Lying on back Prone \>=20minutes Subject Lying face down Facing Left \>=20minutes Subject's Chest facing Reassure device Facing Right \>=20minutes Subject's Back facing Reassure device Foetal Left \>=20minutes Subject's Chest facing Reassure device Foetal Right \>=20minutes Subject's Back facing Reassure device

Eligibility Criteria:
Inclusion Criteria:

* Willing Volunteer

Exclusion Criteria:

* Restless leg syndrome
Transoral Incisionless Fundoplication Database Repository (TIF)

Collect data on individuals who have a transoral incisionless fundoplication (TIF) performed by physicians at Indiana University for the treatment of gastroesophageal reflux disease.

Collect patient information related to transoral incisionless fundoplication (TIF) done for gastroesophageal reflux disease. The database information with be used for research to assess trends improve patient care.

Eligibility Criteria:
Inclusion Criteria:

* Having a TIF procedure completed at Indiana University Health, University Hospital

Exclusion Criteria:

* under 13 years of age
A Registry Study on Hospitalized Patients With Community-acquired Pneumonia in Real-life of China

The purpose of this study is to evaluate the disease burden of hospitalized patients with CAP and HCAP in real life of China

In China, the data about current management of patients hospitalized with community acquired pneumonia (CAP) in the real-life setting is not available,type of pneumonia, selection of initial antibiotic, time to clinical stability, antibiotic choice anf modification,clinical outcomes and costs remain unclear.

In this study, we will collect comprehensive information on CAP and healthcare associated pneumonia (HCAP) management patterns to evaluate the disease burden of hospitalized patients with CAP and HCAP in real life of China .to analyze microbiological characteristics,clinical manifestations,antibiotic regimens ,adherences to guidelines and effect on outcome in different groups of patients with CAP (\> and = 65 years, different comorbidities ,risk factors) ,to investigate microbiological characteristics,clinical manifestations,antibiotic regimens ,adherences to guidelines and effect on outcome in different groups of disease severity with CAP ,to provide the difference on microbiological characteristics,clinical manifestations,antibiotic regimens ,and outcome between patients with CAP and HCAP ,to understand the current situation of antibiotic regimen ,to evaluate influence of different antibiotic regimens on prognosis.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> or = 14 years of age
* Patient meets the criteria of community acquired pneumonia
* Patient meets the criteria of healthcare-associated pneumonia
* Informed consent to participate in the study is provided

Exclusion Criteria:

* Patients participating in a clinical trial or other intervention studies
* Patients \<14 years of age
* Patient meets the criteria of hospital acquired pneumonia
* Known active tuberculosis or current treatment for tuberculosis
* Non-infectious pulmonary diseases （e.g. pulmonary embolism, pulmonary edema, pulmonary vasculitis, interstitial pneumonia）
* HIV positive
Non-pharmacological Prevention of Stroke in Patients With Non-valvular Atrial Fibrillation

Left atrial appendage (LAA) occlude devices are used for over ten years. According to current data efficiency and safety of this approach at least comparable with pharmacological prevention of stroke in patients with non-valvular atrial fibrillation.

However, to date, LAA occluder implantation is not recommended as an alternative for conservative therapy and reserved for patients with contraindications for oral anticoagulants only. In the same time, long-term follow-up of patients enrolled in clinical trials and data from registries showed that LAA occlude device implantation as an alternative to oral anticoagulation could reduce drug load, decrease complexity and cost of treatment and thus improve patients' quality of life, and potentially may reduce the risk of death. The aim of our study is to investigate the risk of all-cause death, stroke, and bleedings in patients with LAA occluder implanted as an alternative to anticoagulant therapy.

Three hundred patients with atrial fibrillation will undergo LAA occluder implantation. For LAA occluder sizing transesophageal echocardiography (TEE), CT and LAA angiography will be performed. The follow-up period will be 36 months. The incidence of all-cause death, stroke, bleeding BARC≥2, device-related complications and QOL will be investigated.

The patients will be followed in the clinic at three and six months, and then at 12, 24 and 36 months, the telephone calls for getting information about endpoints events will be done. Additional in clinic visits will be scheduled if the late complications will be suspected.

TEE will be performed at three and six months to check for device leak, displacement and thrombosis.


Eligibility Criteria:
Inclusion Criteria:

* Patient with paroxysmal/persistent/permanent atrial fibrillation
* CHA2DS2VASc score ≥2 for male and ≥3 for female
* Without contraindications to anticoagulation therapy

Exclusion Criteria:

* LAA thrombosis
* mechanical prosthetic heart valve
* moderate or severe mitral valve stenosis
The Effect of Alginate on Carbohydrate and Fat Digestion in a Mixed Meal

This study will investigate the effect of an extract of brown seaweed, called alginate, on fat digestion. The extract has been cooked into sausages and the alginate sausages will be compared to the same sausages that do not contain alginate. People taking part in the study will come to the study centre twice. Once to have the alginate sausage meal or the normal sausage meal and on the second visit they will have the other meal so then end up having had both types of sausages. The level of fat in their blood will be monitored over the four hours after the meal. The rate and amount of fat that moves into the blood after a meal is an indication of the amount of fat digestion. We believe that less fat will be digested and move into the blood when the volunteers eat the alginate sausages compared to the normal sausages.

Alginate is an extract of brown seaweed and has been shown to reduce lipase activity in vitro. Lipase is a valid target for anti-obesity products as shown by the pharmaceutical drug orlistat which targets the same enzyme. Reducing the amount of lipase activity will reduce the amount of triacylglycerol (TAG) that will be digested and therefore absorbed and will be seen as a reduction in the level of circulating TAG in the blood. Adding alginate to a range of food products that are simple to include into the diet could help with the management of obesity. In this study, sausages containing alginate have been manufactured for us along with matched control sausage. The circulating TAG in the blood will be measured via fingerpick blood samples every 30 minutes for four hours after the volunteers have eaten either alginate sausages or normal sausages. The volunteers will come for two visits and consume the other sausage meal at the second so they will have had both types of sausage.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* pregnant or lactating.
Radial Forearm Versus the Ulnar Forearm Free Flap

This study evaluates donor site outcomes in patients receiving radial forearm free flap reconstruction versus ulnar forearm free flap reconstruction. Patients who meet criteria for forearm free flap reconstruction are randomized to receiving either radial forearm free flap or ulnar forearm free flap reconstruction.

The radial forearm free flap and the ulnar forearm free flap are both well-described procedures used for free tissue transfer in reconstructive surgery. Although forearm free flaps are frequently performed, there is insufficient prospective data looking at the morbidity of the radial compared to ulnar forearm free flaps. The goal of this research study is to characterize the outcomes for each of these two flaps, and to determine if there is surgical equipoise, or if one flap is better than the other.

Eligibility Criteria:
Inclusion Criteria:

* Patients with planned forearm free flap reconstruction
* Patients who are deemed equal surgical candidates for radial forearm free flap and ulnar forearm free flap reconstruction
* Preoperative Allen's test completed and passed
* Patients have the capacity to complete the informed consent process

Exclusion Criteria:

* Patients that are not candidates for a forearm flap based on their physiology
* Clinically evident peripheral neuropathy (e.g., diabetic neuropathy, leprosy)
* Patients requiring concurrent forearm bone for reconstruction
* Child, prisoner, or other vulnerable group
A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With AML or MDS

This is the first study of the safety of increasing dose levels of AEB1102 in patients with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome. The study will also evaluate the amounts of AEB1102 in blood, the effects of AEB1102 on blood amino acid levels and the antitumor effects of AEB1102.


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide informed consent
* Age 18 and older
* Diagnosis of AML or MDS according to the WHO criteria
* AML relapsed or refractory to at least one attempt at induction or subjects not candidates for aggressive induction regimens
* MDS refractory to treatment with HMA therapy or with recurrence or progression of MDS following a response to an HMA
* Has adequate organ function: AST and ALT \< 3X the ULN, serum bilirubin \< 2X the ULN, serum creatinine of \< 2 mg/dL, or a calculated creatinine clearance of \> 50 mL/minute
* ECOG Performance Score of 0 -2
* Recovered from the effects of any prior systemic therapy, radiotherapy or surgery
* Willing to use physician approved birth control method

Exclusion Criteria:

* Current CNS Leukemia
* Acute promyelocytic leukemia or AML with a t(15;17) (q22;q12) cytogenetic abnormality or Bcr/Abl positive leukemia
* \< 60 days from ASCT; has chronic graft-versus host disease (GVHD) or requires continued treatment with systemic immunosuppressive agents
* Uncontrolled infection
* Known HIV, hepatitis B or hepatitis C.
* Other active malignancy that requires therapy
* If female, is lactating or breast feeding
* Hypersensitivity to PEG or other component of AEB1102 (Co-ArgI-PEG)
Combined NMES,FEES and Traditional Swallowing Rehabilitation in the Treatment of Stroke-related Dysphagia

The investigators aimed to evaluate effects of combined NMES, FEES and traditional swallowing rehabilitation in stroke patients with moderate-to-severe dysphagia.

Neuromuscular electrical stimulation (NMES)and Fiberoptic endoscopic evaluation of swallowing (FEES) are both promising approaches to enhance swallowing recovery for dysphagic patients. However, there is no literature on the effectiveness of combined application of these modalities in the treatment of patients with poststroke dysphagia. The purpose of this study was to prospectively investigate whether combined NMES, FEES and traditional swallowing rehabilitation can improve swallowing functions in patients with moderate-to-severe dysphagia after stroke.

Eligibility Criteria:
Inclusion Criteria:

* age between 20-85 years old
* first-time stroke confirmed by computed tomography or magnetic resonance image
* dysphagia \> 3 weeks, with preservation of the swallowing reflex
* currently on a restricted diet, with a Functional Oral Intake Scale (FOIS) score of 5 or less
* Mini-Mental State Examination (MMSE)\> 21
* no obvious mental depression, receptive aphasia or cognitive impairment

Exclusion Criteria:

* progressive cerebrovascular disease or other neurologic diseases
* unstable cardiopulmonary status, serious psychologic disorder or epilepsy;
* tumors, extensive surgery or radiotherapy of the head and neck region
* cardiac pacemakers
* swallowing therapy within 2 months before participation
Expanded Evaluation of the Survivorship Wellness Group Program in the Context of COVID-19 and Telehealth

This study evaluates the effects of the Survivorship Wellness Group Program following active treatment, as well as to learn from Survivorship Wellness participants about their concerns regarding the current COVID-19 pandemic. This study may help to evaluate the impact of the survivorship program on patient well-being, provide evidence for use in grant application and publications, and ultimately inform the continued improvement of survivorship care.

PRIMARY OBJECTIVES:

1. To examine the feasibility and acceptability of implementing an interdisciplinary goal-setting clinical group program focused on domains of physical, psychological, and spiritual wellness for survivors of cancer at University of California San Francisco (UCSF).
2. To determine preliminary efficacy of the Survivorship Wellness intervention in regards to:

   1. Increasing knowledge of and perceived confidence in execution of health behavior changes in domains of physical, emotional, and spiritual wellness for survivors of cancer.
   2. Increasing quality of life.
   3. Reducing symptoms of depression and anxiety.
   4. Increasing physical activity.
3. To assess differences in patient wellbeing and in the impact of the Survivorship Wellness program during the period of COVID-19 and telehealth classes.

OUTLINE:

Patients complete surveys over 5-10 minutes at baseline (i.e. before participating in the program), and at 9 and 15 weeks follow up on the impact of COVID-19 on survivorship. Patients also complete a survey assessing how patients rate telehealth classes in the Survivorship Wellness program.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Treated for any kind of cancer at UCSF, though finished with active treatments (defined as chemotherapy, radiation, or surgery) at time of enrollment, and without evidence of current active cancer
* Sufficient cognitive ability to participate in group activities as determined by their attending medical oncologist or surgeon

Exclusion Criteria:

* Non-English speaking
* Primary cancer treatment outside of UCSF
* Currently receiving non-maintenance therapies (chemotherapy or radiation) for active cancer
* Psychiatric illness that would affect the ability to participate in a group activity
Carpal Tunnel Syndrome Treatment: Surgery Vs. Injections

This prospective randomized controlled study included 68 patients (aged 18-70) with mild to moderate carpal tunnel syndrome (CTS), randomized into three groups: surgical treatment (25 patients, 25 wrists), corticosteroid (CS) treatment (20 patients, 32 wrists), and platelet-rich plasma (PRP) treatment (23 patients, 35 wrists). Diagnosis was confirmed through clinical evaluation and electrodiagnostic (EDX) testing, with assessments including the Visual Analog Scale (VAS), Boston Carpal Tunnel Questionnaire (BCTQ), ultrasonographic median nerve cross-sectional area (CSA) and flattening ratio (FR), and sensory/motor conduction parameters. Treatments were ultrasound-guided CS (1 mL triamcinolone, 40 mg/mL) or PRP (1 mL extracted from centrifuged venous blood) injections, while surgical treatment involved standard open carpal tunnel release using the WALANT (Wide Awake Local Anesthesia No Tourniquet) technique. Follow-ups were conducted at 1, 3, and 6 months, and the study was ethically approved with informed patient consent.


Eligibility Criteria:
Inclusion Criteria:

minimum of 3 months duration of symptoms and mild to moderate CTS

Exclusion Criteria:

* 1) Patients with severe CTS diagnosed with EMG or the presence of thenar atrophy, 2) Polyneuropathy, 3) Previous injection therapy for CTS, 4) Previous CTS surgery, 5) Pregnancy or lactation.
Elderly Primary Insomnia Polysomnographic Study (0928-002)(TERMINATED)

The purpose of the study is to test the safety and effectiveness of an Investigational Drug on insomnia in the elderly.


Eligibility Criteria:
Inclusion Criteria:

* Elderly patients with a diagnosis of primary insomnia and in good physical and mental health
Community Park-Based Programs for Health Promotion: the Fit2Lead Prospective Cohort Study

The Fit2Lead prospective cohort study examines the effects of a park-based youth mental health and resilience afterschool program on youth participant mental health, resilience, physical fitness, and violence prevention outcomes. Duke will perform a secondary analysis of the data collected as part of the Fit2Lead prospective cohort study run by Miami-Dade County Parks and Recreation.

The Fit2Lead prospective cohort study examines the effects of a park-based youth mental health and resilience afterschool program on youth physical and mental health and resilience, communication, and problem-solving skills training for underserved youth aged 12 to 17 years through an interdisciplinary collaboration among Miami-Dade Department of Parks, Recreation and Open Spaces (MDPROS) Miami-Dade County (MDC) Juvenile Services Department, MDC Public Schools, MDC Police Department, University of Miami, Florida International University, and other community-based partners.

Fit2Lead consists of 2 phases initiated simultaneously in 2015. For youth aged 12 to 14 years, Fit2Lead is offered after school Monday through Friday from 3:00 pm to 7:00 pm at 12 MDC parks for participants in under resourced neighborhoods and based on area-level youth crime and neighborhood poverty. Fit2Lead runs September through June at no charge, and provides daily academic support, sports and recreation, meditation, stress resilience, and life skills-focused workshops. Each park serves anywhere from 2 to 9 feeder schools within these neighborhoods (a target population of 34 000 youth residents aged 12-17 years), and transportation from schools to parks is provided at no cost within a 3-mile radius of a program park. Fit2Lead participants can also enroll in the MDPROS youth summer camp at no charge.

Phase II of Fit2Lead is for youth aged 15 to 17 years and entails a year-round paid internship and 3-hour weekly enrichment, resilience, and life skills workshops. Daily entry-level part-time interns receive $9 per hour (approximately 500 total paid hours per year; total salary approximately $4000 per participant, per year). Work assignments support MDPROS operations and recreation staff. Interns rotate every 8 weeks for exposure to different job opportunities, supervisors, and mentors. Phase 1 participants who reach age 15 years and are awaiting an internship placement can remain in phase 1 until a position opens or can be transferred to another internship program within the MDPROS.

Eligibility Criteria:
Inclusion Criteria:

* All participants enrolled in the Miami-Dade Fit2Lead study will be included in this secondary analysis
* Aged 12-17 years, residing in Miami-Dade County

Exclusion Criteria:

* Anyone not enrolled in the Miami-Dade Fit2Lead study will be excluded from this secondary analysis
* Aged \&lt;12 or \&gt;17 years, not residing in Miami-Dade County, cannot read and speak in English