cyrilzakka/clinical-trials huggingface dataset:
Effect of Antifibrotic Therapy on Regression of Myocardial Fibrosis After Transcatheter Aortic Valve Implantation (TAVI) in Aortic Stenosis Patients With High Fibrotic Burden

The aim of the study is to evaluate the effect of antifibrotic therapy on regression of myocardial fibrosis after TAVI in patients with baseline high fibrotic burden. Therefore, patients will be treated with Spironolactone in addition to standard of care, Spioronolactone + Dihydralazine in addition to standard of care or according to standard of care alone without any study medication. First, differences between patients in the control arm and patients randomized to anti-fibrotic therapy will be analyzed. The second analysis will determine, whether dihydralazine medication in addition to spironolactone is able to increase a potential antifibrotic effect. Myocardial fibrosis will be assessed by cardiac magnetic resonance imaging (CMR) before TAVI and 1 year after. Quantification of potentially irreversible replacement fibrosis will be carried out by late gadolinium enhancement (LGE), and quantification of the potentially reversible diffuse interstitial fibrosis will be performed by measurement of the extracellular volume fraction (ECV), thereby deriving matrix volume and cell volume.


Eligibility Criteria:
Inclusion Criteria:

* Male, female age ≥ 60
* Diagnosis of severe symptomatic aortic stenosis
* Transcatheter aortic valve implantation (TAVI) scheduled
* Written informed consent

Exclusion Criteria:

* 1. Pre-existing dilative or ischemic heart disease with EF\<35% and guideline indication for spironolactone
* Patient on current medication with spironolactone, eplerenone, or dihydralazine
* Presence of coexistent myocardial pathology such as cardiac amyloidosis, hypertrophic cardiomyopathy, or myocarditis
* Presence of coexistent severe aortic regurgitation or severe mitral stenosis
* Previous surgical valve replacement or repair
* Pacemaker or ICD implanted
* Renal impairment (serum creatinine \> 1,8 mg/dl and/ or GFR \< 30 ml/min/1,73 m² BSA)
* Significant hypotension (blood pressure \< 90 mm Hg systolic and/or \< 50 mm Hg diastolic
* Serum potassium \> 5,1 mmol/l
* Contraindications for Spironolactone (anuria, acute renal failure, serum creatinine \> 1.8 mg/dl, hyperkalemia, pregnancy)
* Contraindications for Dihydralazine (known allergy or hypersensitivity, systemic lupus erythematodes, adrenocortical disorders)
* Known active malignant disease with life expectancy \< 1 year
* Women with child-bearing potential
* Simultaneous participation (including a waiting period of 4 weeks) in other interventional clinical trials
* Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial
* Person who is in a relationship of dependence/employment with the sponsor or the investigator
The Effect of Exercise on Mood After Traumatic Brain Injury

We proposed to examine the effect of an aerobic exercise intervention on depression in persons with Traumatic Brain Injury (TBI). We will compare persons with chronic brain injury who are assigned to receive the exercise intervention with those in the control group to determine the effect of exercise on levels of depression and specific symptoms related to depression including anxiety, pain, sleep, and cognition. In addition, the effect of exercise on activity, participation level, and quality of life will be examined.

HYPOTHESES:

1. Participation in an aerobic exercise intervention will decrease the severity of depression in persons with chronic TBI.
2. Participation in an aerobic exercise intervention will lead to improvements in negative symptoms associated with depression including anxiety, insomnia, pain, and impaired cognitive functioning.
3. Participation in an aerobic exercise intervention will be related to improvements in activity and participation for patients with TBI.
4. Participation in an aerobic exercise intervention will lead to improvements in perceptions of quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Traumatic brain injury 1-5 years prior to enrollment
* Current depression as measured by a score of 5 or greater on the depression portion of the Physician Health Questionnaire (PHQ).
* Sufficient cognitive ability to maintain participation in the study
* Sufficient English language ability to allow participation without an interpreter

Exclusion Criteria:

* Current suicidal ideation with intent or plan
* Currently pregnant
* History of significant cardiovascular or respiratory disease
* History of significant cardiovascular or respiratory disease
* Physical barriers to the use of standard aerobic exercise equipment
Study of Phasix™ Mesh for VHWG Grade 3 Midline Hernia Repair

The purpose of this study is to collect additional data on safety and performance of Phasix™ Mesh in subjects requiring Ventral Hernia Working Group (VHWG) Grade 3 midline hernia repair.

Approximately 85 subjects, at approximately 12 sites across Europe will be enrolled and treated to study the use of Phasix™ Mesh. All treated subjects will be followed for 2 years post-implantation.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be diagnosed with incisional midline hernia.
* Subject has a VHWG Grade 3 hernia (as defined in the protocol).
* Size of hernia ≥ 10 cm2.
* Subject must be willing to undergo a planned retro-rectus hernia repair (onlay allowed as an exception when retro-rectus placement cannot be achieved; using absorbable suture) with or without Component Separation Technique.

Exclusion Criteria:

* Subject with \> 4 previous repairs of the hernia under observation.
* Body Mass Index (BMI) \> 35 kg/m2.
* The subject is on, or suspected to be placed on, chemotherapy medications during any part of the study.
* The subject has peritonitis.
* Known human immunodeficiency virus (HIV) infection (if documented in the subject's record).
* The subject has cirrhosis of the liver and/or ascites.
* Subject is American Society of Anesthesiology Class 4 or 5.
* Complete removal of existing mesh from a prior hernia repair (in the same affected area) is not possible.
* The hernia repair requires more than a single piece mesh (with adequate overlap beyond the margins of the defect on all sides).
* Subject has intact permanent mesh adjacent to the current hernia to be repaired.
* Subject's hernia repair requires intraabdominal mesh placement.
* Surgical technique requires surgical bridge repair as the sole repair.
* Subject has any condition that, in the opinion of the Investigator, would preclude the use of the study device, or preclude the subject from completing the follow-up requirements.
* Subject is pregnant or has plans to become pregnant during the study period or is currently breastfeeding.
* Subject has an alcohol/substance abuse problem or has had a relapse within 12 months of the screening visit.
* Subject was involved in another interventional clinical study in the last 30 days prior to Informed Consent Form (ICF) signature.
* Subject is part of the site personnel directly involved with this study.
* Subject has a life expectancy of less than 2 years at the time of enrollment.
* Subject has a known sensitivity to Phasix™ Mesh or component materials (patients with known allergies to tetracycline hydrochloride or kanamycin sulfate should be avoided).
PERformance of Multi-Cancer Early-detectIon Based on Various Biomarkers in fEmale Cancers, PERCEIVE-I

This study is a prospective study aimed to develop and validate the performance of combined multi-omitcs assays for early detection of gynecologic cancers. Biomarkers of cfDNA methylation, ctDNA mutation and blood miRNA markers will be evaluated. The study will enroll approximately 495 female participants, including participants with gynecologic cancers or benign diseases.


Eligibility Criteria:
Inclusion Criteria for Cancer Arm Participants:

* Age 18 years or older
* Able to provide a written informed consent
* Confirmed diagnosis or highly suspicious cases of gynecologic malignancies
* No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw

Exclusion Criteria for Cancer Arm Participants:

* Pregnancy or lactating women
* Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant
* Recipients of blood transfusion within 7 days prior to study blood draw
* Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer

Inclusion Criteria for Benign Arm Participants:

* Age 18 years or older
* Able to provide a written informed consent
* Confirmed diagnosis of benign gynecologic diseases
* No prior radical treatment of the benign diseases prior to study blood draw

Exclusion Criteria for Benign Arm Participants:

* Pregnancy or lactating women
* Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant
* Recipients of blood transfusion within 7 days prior to study blood draw
* Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer
A Randomized, Prospective Clinical Trial of Immediate Flap Closure Versus Wound Care for Management of Late-stage Pressure Ulcers

The purpose of this study is to compare the number of and degree of pressure ulcers healed, as measured by intact skin at the original ulcer site at 6 months of follow-up in patients randomized to immediate operative closure versus those who are maintained in a wound care program in patients with Stage 3 and 4 sacral and peri-sacral decubitus ulcers.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old;
* Stage III or IV pressure ulcers on or near trochanter, ischium, sacrum or buttocks;
* Receiving treatment at the Center for Wound Management - Goleta Valley Cottage Hospital; Santa Barbara Cottage Hospital or Santa Ynez Cottage Hospital, all part of Cottage Health System;
* Underlying etiology for immobility secondary to spinal cord injury (SCI) or other neuromuscular condition not expected to become progressive in next 12 months;
* No contraindications to undergo surgical intervention, including medical ability to tolerate surgical procedure with general anesthesia.

Exclusion Criteria:

* Unable or unwilling to provide informed consent;
* Underlying cause of immobility secondary to chronic medical disease outside of nonprogressive SCI or neuromuscular disease as described above;
* Patients requiring immediate surgical closure determined by physician judgment;
* Those deemed inappropriate to consider for surgery outside of study; potential reasons normally include medical comorbidities, inability to comply with post-operative care, and lack of funding source for elective procedure, peri-operative, and / or wound care.
* Patients who have already been receiving active, professionally supervised wound care for \> 2 week period prior to presentation
* Patient is pregnant or breastfeeding.
Imaginal Exposure II Study: In-Vivo

The purpose of this study is to test if imaginal exposure therapy can decrease symptoms of eating disorders and anxiety.

An initial meeting consisting of a screening, questionnaires, and a brief psychoeducation on imaginal exposure therapy, followed by 8-10 sessions with a licensed psychologist (the PI) or a clinical psychology graduate student who is supervised and trained by the PI. In Session 1, patients will create a script with the therapist on an eating disorder fear. In sessions 2-10 the therapist and patient will then imagine this eating disorder related fear based on the script. Each session will be modified to focus on "hot spots" or the most feared aspect of the script. Sessions will be audiotaped and videotaped and participants will be asked to listen to the sessions nightly for homework. Sessions will be weekly or twice per week for 8-10 weeks after the initial screening session.

Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years of age (no age limit)
* Must currently meet criteria for anorexia, sub-clinical anorexia, bulimia, or sub-clinical bulimia (using the eating disorder diagnostic scale), OR have met criteria for one of these eating disorders in the last year, OR endorse significant eating disorder fears
* Must have at least one significant eating disorder related fear.

Exclusion Criteria:

* Under 18 years of age
* Individuals who have binge eating disorder or an unspecified eating disorder, OR who do not meet eating disorder related criteria
* Individuals who meet criteria for mania, psychosis, or suicidal ideation
* Participants who are not able to secure transportation to complete therapy sessions
Combination Regimen With Sodium Valproate for Severe Hemophilia: a Single-arm, Phase 1, Pilot Trial.

The goal of this clinical trial is to determine the clinical efficacy and toxic effects of sodium valproate, sirolimus and calcitriol in the treatment of severe haemophilia in participants with severe haemophilia . The main questions it aims to answer are the possibility of adding a combination regimen to primary treatment for severe haemophilia . Patients will receive oral sodium valproate extended-release tablets 0.5g/day, sirolimus tablets 1mg/day and osteopontin capsules 0.25μg/day.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with clinically confirmed severe haemophilia;
2. Expected survival of ≥ 24 weeks with an ECOG score of 0-2;
3. Not having participated in another clinical trial within four weeks;
4. Informed consent signed by the patient or an immediate family member.

Exclusion Criteria:

1. Those with other types of blood disorders diagnosed at the morphological or molecular level of the bone marrow;
2. Significantly abnormal cardiopulmonary function;
3. Hepatic or renal insufficiency;
4. Pregnancy or lactation, or inability to use contraception during the trial and for three months before the test and one year after administration
5. Persons who are allergic to the drugs likely to be used or where there is a contraindication to their use;
6. Those with severe uncontrollable infectious diseases or uncontrolled hypertension, malignancy, etc.;
7. Inability to cooperate with a regular follow-up due to psychological, social, family and other geographical circumstances;
8. Any other condition that, in the investigator's opinion, makes participation in this trial inappropriate.
Assessment of Oral and Nasal Breathing With Sensors Analyzing Algorithm

The goal of this observational study is to learn about the agreement between sensors analyzing algorithm and body plethysmography in measuring oral and nasal breathing in healthy adults, and in patients with chronic rhinosinusitis, asthma and chronic obstructive pulmonary disease. The main question it aims to answer is: • Is the algorithm-based method accurate enough in analyzing respiratory obstruction as compared to body plethysmography (reference method)? Participants will perform a short breathing protocol (oral and nasal breathing with different masks) during which time their breathing is monitored with both methods.

The data collected in the Patient Registry include: Parameters on general health, like previous illnesses, medications, height, weight, answers to symptoms queries and queries on quality of life (Asthma test, COPD test, Sinonasal Outcome Test 22) as well as results from the examined medical devices (body plethysmography, spirometry, sensors analyzing algorithm).

Eligibility Criteria:
Inclusion Criteria:

* 5 healthy and asymptomatic volunteers with regard to lungs and nose
* 5 patients with allergic rhinitis or nasal polyps (diagnosis of allergic rhinitis confirmed by a PRICK test or specific Ig E antibody tests and Nasal polyposis diagnosed by an ENT specialist, with endoscopy)
* 5 patients with asthma (diagnosis of asthma based on peak expiratory flow (PEF) monitoring, spirometry, or other appropriate objective measurement methods performed by a pulmonologist
* 5 patients with Chronic Obstructive Pumonary Disease (diagnosis of COPD based on spirometry (post-bronchodilator Forced Expiratory Volume/ Forced Vital Capacity (FEV1/FVC) ratio below 0.70)

Exclusion Criteria:

* Pregnancy.
* History of surgical procedures in the chest, larynx, throat (excluding tonsillectomy), or nasal area.
* Recent illnesses or surgeries that pose a risk to the patient or prevent proper measurement (common contraindications for spirometry):
* Recent (\<1 month) myocardial infarction.
* Severe coronary artery disease with easily triggered symptoms.
* Cerebral artery aneurysm.
* Recent brain (\<4 weeks) or eye (\<1 week) surgery.
* Severe cardiac arrhythmias.
* Pulmonary tuberculosis.
* Pneumothorax
* Immediate postoperative period of lung surgery (\<1 day).
* Dementia or confusion.
Biospecimen Analysis in Determining Effects of Chemotherapy on Fertility in Osteosarcoma Survivors

This research trial studies saliva, semen, and blood samples to determine effects of chemotherapy on fertility in osteosarcoma survivors. Study biospecimen samples from osteosarcoma survivors in the laboratory may help doctors learn whether chemotherapy causes fertility problems and to learn more about the long term effects.

PRIMARY OBJECTIVES:

I. Determine whether infertility and/or biomarkers of spermatogenesis and steroidogenesis differ in male osteosarcoma survivors treated with cisplatin with or without ifosfamide compared to male controls without a history of cancer.

II. Evaluate whether cisplatin with or without ifosfamide for the treatment of osteosarcoma alters sperm deoxyribonucleic acid (DNA) methylation.

EXPLORATORY OBJECTIVES:

I. Evaluate the role of genetic susceptibility in the development of impairments in spermatogenesis or steroidogenesis with contemporary regimens for the treatment of osteosarcoma.

OUTLINE:

Participants complete a health questionnaire over 30-45 minutes. Patients also provide saliva and semen samples and undergo collection of blood.

Eligibility Criteria:
Inclusion Criteria:

* Received upfront therapies for osteosarcoma, which included cisplatin, (with or without other agents)
* Patient must have completed cancer treatment \>= 2 years prior to study enrollment
* Osteosarcoma survivors without a systemically treated relapse or subsequent malignancy

  * Note: History of relapse or second malignancy is permitted if treated with local therapy only (e.g. surgery, radiation)
* Able to speak, read and write in English, French or Spanish
* All patients and/or their parents or legal guardians must sign a written informed consent
* All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Slowing the Degenerative Process, Long Lasting Effect of Hyperbaric Oxygen Therapy in Retinitis Pigmentosa

Our aim was to assess the role and usefulness of Hyperbaric oxygen therapy in a long lasting period, assessing its efficacy on rescuing retinal photoreceptors and preserving visual function in retinitis pigmentosa.


Eligibility Criteria:
Inclusion Criteria:

* Patients with clearly hereditary RP (we performed to all of them genetic analysis for rhodopsin, and peripherin genes, only 4 patient with ADRP showed point mutation 3 on codon 135 and 1 on codon 347); best corrected visual acuity (BCVA) ≥ 0.50 logMAR; visual field ≥ 3 degree diameter circle; recordable ERG.

Exclusion Criteria:

* Exclusion criteria were: patients with sporadic RP; BCVA ≤ 0.50 logMAR; visual field ≤ 3 degree diameter circle; not recordable ERG.
The Prevent Anal Cancer Self-Swab Study

The purpose of this research study is to find ways to screen for anal cancer among gay, bisexual, and other men who have sex with men (MSM) and transgender persons. This study will try to find out if persons will do annual anal cancer screening, what factors are associated with repeated screening, and how this affects a person's decision to have high-resolution anoscopy.

This is a prospective, randomized, two-arm clinical study to evaluate compliance with annual home-based vs clinic-based DNA screening of anal canal exfoliated cells among Milwaukee HIV+ and HIV- men who have sex with men (MSM) and transgender persons aged ≥25 years. At study entry, persons randomized to arm 1 will receive a home-based collection kit in the mail at 0 and 12 months and those in arm 2 will attend a clinic where a clinician will collect the exfoliated cell specimen at 0 and 12 months. Then, persons will receive high-resolution anoscopy (HRA)-directed biopsy to assess precancerous lesions by study arm. We hypothesize that a majority of persons will comply with annual screening with increased compliance among persons in the home-based arm vs clinic-based arm. The proposed research could indicate that annual HPV DNA screening and subsequent HRA are acceptable to MSM and transgender persons; thus, we will determine how high-risk persons are identified for HRA in light of limited HRA resources. The duration of each participant's activities is expected to be 12 months. The study is expected have participant activity from 2019 to 2023.

Eligibility Criteria:
Inclusion Criteria:

* Be \> 25 years of age
* Sex at birth is male or gender identity is a transgender person
* Acknowledge sex with men in the last 5 years, or identify as gay or bisexual
* Understand and be willing to give informed consent
* Be willing to be randomized and able to comply with the protocol
* Spanish and/or English speakers/readers, and
* HIV+ or HIV-

Exclusion Criteria:

* Not acknowledge sex with men in the past five years and not identify as gay or bisexual
* Use of anticoagulants other than Aspirin or NSAIDS
* Prior diagnosis of anal cancer
* Plans to move within 12 months
* Not Milwaukee metro residents
* Not willing to attend one of the designated study clinics at baseline, or
* Inability to give informed consent