cyrilzakka/clinical-trials huggingface dataset:
Adipose-derived SVF for Treatment of Erectile Dysfunction (ED)

This study will examine the safety and feasibility of a single injection of autologous adipose-derived stromal vascular fraction to treat erectile dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* history of ED of at least 3 months' duration
* have been taking a Phosphodiesterase type 5 (PDE5) inhibitor for at least 1 month prior and willing to stop taking any PDE5 inhibitor for duration of study
* have an IIEF-EF domain score that is ≥11 and ≤25
* have the same sexual partner for the duration of the study
* subject and partner willing to voluntarily give consent
* speak, read and understand English

Exclusion Criteria:

* non-responders to PDE5 inhibitor
* radical prostatectomy or other pelvic surgery or penile implant
* currently taking blood thinners, cancer drugs or HIV drugs
* allergic to lidocaine, epinephrine, valium
* diminished decision-making capacity
* use of tobacco
* previous pelvic or abdominal radiation therapy
* anti-androgen therapy
* untreated hypogonadism
* uncontrolled hypertension or hypotension
* unstable cardiovascular disease
* systemic autoimmune disorder
The Effects of Tai Chi and Pilates for Individuals With Prediabetes

The purpose of this study; To investigate the effects of Clinical Pilates and Tai Chi exercises on glycemic control, body composition, balance function and physical activity level in individuals with prediabetes.

The purpose of this study; To investigate the effects of Clinical Pilates and Tai Chi exercises on glycemic control, body composition, balance function and physical activity level in individuals with prediabetes. Method: 54 individuals diagnosed with Prediabetes in the Endocrinology and Metabolic Diseases Polyclinic at Niğde Ömer Halisdemir Training and Research Hospital will participate in our study. Individuals will be divided into 3 groups: Clinical Pilates group, Tai Chi group and control group. Before exercise, routine blood tests of individuals will be performed and their fasting and postprandial blood glucose and HbA1C (Glycosized Hemoglobin) levels will be checked. Bioelectrical Impedance Device will be used to evaluate body composition. Timed Up and Go Test and Berg Balance Scale will be used to evaluate individuals' balance functions. Physical Activity level of individuals will be measured using the International Physical Activity Level Scale (IPAQ) and the Accelerometer device. Evaluations will be repeated in all groups at the end of the 12-week exercise application. SPSS (Statistical Package Program for Social Science) software will be used to analyze the data. Statistical analysis of the study will be done with Wilcoxon related two-sample test for intra-group measurements, and Man Whitney U test for inter-group evaluations. For the significance level, p value will be accepted as p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent biochemistry analysis for their glycemic control as part of routine checks at the Endocrinology and Metabolic Diseases Polyclinic.
* Patients who do not use any medication related to prediabetes
* Being able to walk independently
* Volunteering to exercise at least 3 days a week within the scope of the research

Exclusion Criteria:

* Those diagnosed with type 1 diabetes, Latent Autoimmune Diabetes in Adults (LADA)
* Going into a diabetic ketoacidosis coma,
* Having an orthopedic problem that prevents walking and exercising
* Having an orthopedic or vascular problem with the foot
* Having any neurological disease
* Cardiac, pulmonary or systemic disease that would prevent exercise have
* Losing more than 4 kg of weight per month
LGBT Internet Based Smoking Treatment - 1

The overall goals of this line of research are to develop and evaluate innovative treatments for lesbian, gay, bisexual, and transgender (LGBT) cigarette smokers and to understand the processes related to smoking and relapse in this previously unstudied population of smokers. In this study, participants are randomly assigned to one of two Internet-based smoking cessation treatments: 1) a self-help intervention tailored LGBT smokers plus social support plus email-based counseling, or 2) a standard self-help condition alone, similar to other general smoking cessation treatments. Before starting the program, participants will complete measures of smoking, nicotine dependence, depression diagnosis, demographics, mood, motivation to change, and alcohol use. Smoking status will be determined at 1, 3, 6, and 12 months following the start of treatment. Data will be analyzed to compare the quit rates of the two Internet-based treatment groups. Also, we will complete exploratory analyses to determine those variables that best predict quitting for LGBT smokers.


Eligibility Criteria:
Must identify as a lesbian, gay male, bisexual male or female or a transgender individual. Must smoke most days during the preceding month. Must have a valid email address.
Induction Chemotherapy for Locally Recurrent Rectal Cancer

This is a multicentre, open-label, parallel arms, phase IIII study that randomises patients with locally recurrent rectal cancer in a 1:1 ratio to receive either induction chemotherapy followed by neoadjuvant chemoradiotherapy and surgery (experimental arm) or neoadjuvant chemoradiotherapy and surgery alone (control arm)


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Confirmed locally recurrent rectal cancer after total or partial mesorectal resection for rectal or distal sigmoidal cancer either by histopathology ór clinically proven (evidence on imaging in combination with clinical findings, with consensus in MDT)
* Resectable disease determined by magnetic resonance imaging (MRI) or deemed resectable after neoadjuvant treatment with chemoradiotherapy.
* WHO performance score 0-1
* Written informed consent

Exclusion Criteria:

* Radiological evidence of metastatic disease (e.g. liver, lung) at time of randomisation or in the six months prior to randomisation.
* Known homozygous DPD deficiency
* Any chemotherapy in the past 6 months.
* Any contraindication for the planned chemotherapy, as determined by the medical oncologist.
* Radiotherapy in the past 6 months for primary rectal cancer.
* Any contraindication for the planned chemoradiotherapy, as determined by the medical oncologist and/or radiation oncologist.
* Any contraindication for surgery, as determined by the surgeon and/or anaesthesiologist.
* Concurrent malignancies that interfere with the planned study treatment or the prognosis of resected LRRC.
Routine Hysteroscopy in IVF/ICSI Cycles in Patients With Primary Unexplained Infertility

The aim of the present study is to evaluate the impact of hysteroscopy prior to starting the IVF (in vitro fertilisation) cycle on treatment outcome in women with unexplained primary infertility.

Proper history, examination and investigations are carried out to diagnose causes of infertility. Office hysteroscopy will be performed during the Luteal phase of the proceeding menstrual cycle using a rigid hysteroscope. Controlled ovarian hyper stimulation-embryo transfer (COH-ET) using the standard long protocol of induction used in Ain Shams University Maternity Hospitals ART (assisted reproductive techniques) unit.

Biochemical pregnancy will be determined by a positive pregnancy test performed 2 weeks after embryo transfer and clinical pregnancy will be defined by the presence of a gestational sac using transvaginal ultrasound performed 6 weeks after embryo transfer.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing IVF/ICSI using the standard long GnRH-a (gonadotropin-releasing hormone-a) protocol.
* No evidence of uterine pathology by transvaginal ultrasound and hysterosalpingography during the follicular phase.
* Patients with unexplained primary infertility.

Exclusion Criteria:

* Patients undergoing IVF using other protocols of induction.
* Patients with evidence of uterine pathology by transvaginal ultrasound or hysterosalpingography during the follicular phase.
* Other causes of infertility rather than unexplained factor.
* Unexplained poor responders during the pending ICSI cycle.
* Patients with abnormal findings at hysteroscopy.
Machine Learning Assisted Recognition of Out-of-Hospital Cardiac Arrest During Emergency Calls.

Emergency medical Services Copenhagen has developed a machine learning model that analyzes the calls to 1-1-2 (9-1-1) in real time. The model are able to recognize calls where a cardiac arrest is suspected. The aim of the study is to investigate the effect of a computer generated alert in calls where cardiac arrest is suspected.

The study will investigate

1. whether a potential increase in recognitions is due to machine alerts or the increased focus of the medical dispatcher on recognizing Out-of-Hospital cardiac Arrest (OHCA) when implementing the machine
2. if a machine learning model based on neural networks, when alerting medical dispatchers will increase overall recognition of OHCA and increase dispatch of citizen responders.
3. increased use of automated external defibrillators (AED), cardiopulmonary resuscitation (CPR) or dispatch of citizen responders in cases of OHCA on machine recognised OHCA vs. medical dispatcher recognised OHCA.

Chances of survival after out-of-hospital cardiac arrest decrease 10% per minute from collapse until CPR is initiated. dispatcher assisted telephone CPR will be initiated only in cases where the dispatcher recognizes the cardiac arrest.

In a previous project "Can a computer through machine learning recognise of Out-of-Hospital Cardiac Arrest during emergency calls" (supported by TrygFoundation), the investigators found, it was possible to create a Machine Learning (ML) model, which could recognise OHCA with higher precision than medical dispatchers at the Emergency Medical Dispatch Center (EMDC-Copenhagen).

In this study the model andt is effect is to be documented in the EMDC-Copenhagen. For this purpose, a computer server running the ML-model are created. This server is integrated in the network at EMDC-Copenhagen, making it possible to push alerts to the medical dispatcher, when a cardiac arrest is recognised by the model.

With aid of machine learning, the hypothesis is, that recognition of OHCA is improved, and happen both more frequent and faster than present.

An instruction for the medical dispatchers is developed, which guides the medical dispatcher in instance of an alert from the machine.

Eligibility Criteria:
Inclusion Criteria:

* Call regarding a cardiac arrest registered in the national Danish Cardiac Arrest Registry
* OHCA is recognized by machine-learning model
* Call originates from 1-1-2

Exclusion Criteria:

* OHCA Emergency Medical Services - witnessed
* Call is from another authority (police or fire brigade)
* Call is a repeat call
* Call has been on hold for conference
Capillary Refill Time Calculated With a Video-assisted Method Has a Better Reproducibility Than Visual Method in Critically Ill Patients

Capillary refill time is the time it takes for the skin to regain its initial colour after moderate pressure. It is usually performed on the patient index finger, middle finger or ring finger with the examiner's thumb and index finger for five seconds, three measurements having to be averaged. Capillary refill time has a dependent operator character, but it has been shown to be accurately correlated with 14-day mortality in septic shock, hospitalisation need in pediatric population.

The purpose of this project is to show that capillary refill time obtained by a video-assisted method has a better inter- and intra-observer reproducibility than capillary refill time obtained by a visual method.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* hospitalized in ICU
* Patient or Family /relative with Inclusion Authorization

Exclusion Criteria:

* Pregnant or lactating women
* Under protection (guardianship, curators, reinforced curators)
Prevalence of Flexor Hallucis Longus Tears, Associated Os Trigonum Excision, and Return to Play

The study's aim is to determine the incidence of flexor hallucis tendon tears associated with os trigonum excision. The study will then compare the length until functional return to play of the patients who had flexor hallucis tendon tears with concomitant os trigonum excision versus those without flexor hallucis tendon tears who underwent os trigonum excision. Lastly, the study will be evaluating the patient complaints and physical exam findings before and after surgery and compare those without flexor hallucis tendon tears to those with flexor hallucis tendon repair.

Posterior ankle pain syndrome has many etiologies. Two main causes of this are flexor hallucis tendon tear and os trigonum impingement. The current teaching is that patients with flexor hallucis longus tear complain of posterior medial ankle pain and those with posterior lateral ankle pain have an os trigonum impingement. It is also classically understood that patients with flexor hallucis tendon tears take longer to return to their pre-injury level of function. Our clinical experience refutes these reports and our study looks to further evaluate it.

This study brings back patients who were treated by the study doctor. The patient's preoperative evaluation will be reviewed including clinic notes and imaging. The operative reports for these patients will be reviewed to verify the surgery procedure performed. These patients will be included in the study and we will utilize the American Academy of Orthopedic Surgeons Foot, Ankle, and Lower Limb module that they have completed postoperatively. This measure of patient's functional and subjective satisfaction has already been completed by patients at their regularly scheduled follow up appointments and is available for review.

Prospectively, patients will be asked to return to the clinic for a follow-up evaluation, which includes a standard x-ray. All patients will be consented prior to data collection, minors included in this study will be asked to sign an assent as well. Many factors will be assessed such as; a range of motion test of the ankle utilizing goniometric technique, nerve path and function, stability ankle grading, radiologic findings, and patient-reported outcomes filled out pre and postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Os trigonum excision with or without a flexor hallucis longus tear in an athletic population (recreational to competitive)
* Males and females ages 11-50 at time of surgery

Exclusion Criteria:

* Any other injury that will affect their return to play or recovery process
* Individuals not actively involved in athletic sport/activity
* Pregnant women
* Any other concomitant injuries
Levetiracetam Versus Topiramate as Adjunctive Therapy to Evaluate Efficacy and Safety in Subjects With Refractory Partial Onset Seizures

To assess the long-term effects of levetiracetam on retention rate in subjects with refractory partial onset seizure that are not fully controlled with 1 to 3 concomitant antiepileptic drugs, compared to topiramate as add-on therapy during 52 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects from 16 to 80 years, inclusive. Subjects under 20 years may only be included where legally permitted and ethically accepted
* Subjects with refractory epilepsy with partial onset seizure classifiable according to the International League Against Epilepsy (ILAE).
* Subjects having at least 2 partial onset seizures whether or not secondarily generalized during the 8 weeks historical baseline preceding V1 according to ILAE classification
* Subjects having at least 1 partial onset seizures whether or not secondarily generalized per 4 weeks preceding V2 according to ILAE classification
* Subjects with each interval of partial onset seizures less than 6 weeks during entire 12 weeks (8 weeks preceding V1 and 4 weeks preceding V2)
* Subjects being uncontrolled while treated by 1 to 3 permitted concomitant AEDs.
* Permitted concomitant AEDs having been stable and at optimal dosage for the subject from at least 4 week before V1 and during 4 weeks preceding V2 and expected to be kept stable during the Treatment Period.

Exclusion Criteria:

* Subjects presenting any generalized epilepsies classified as type II according to the ILAE classification (ref to publication from 1981)
* Subjects suffering from epilepsies and syndromes undetermined whether focal or generalized (classification III according to the ILAE classification)
* Subjects suffering from special syndromes (classification IV according to the ILAE classification)
* History or occurring only in clusters (too frequently or indistinctly separated to be reliably counted) before V2.
* Presence of exclusively type IA non-motor seizures.
* History or presence of status epilepticus within last 3 months preceding V1 or during Baseline
* History or presence of known pseudo-seizures
* Subjects who are currently on vigabatrin. (Subjects who received vigabatrin in the past and have a normal visual field test are allowed.)
* Subject taking 1 or more of the following medications on a regular basis within 28 days prior to Visit 1: antipsychotics drugs, and psychostimulant (amphetamine derivatives)
Anterior Cruciate Ligament Rupture

The assess results of Anterior Cruciate Ligament (ACL) repair with the Ligamys® surgical technique versus standard technique.

The aim of the study is to compare (laxity, instability, and safety) these two types of treatment by using a prospective, randomised multicenter analysis.

The treatment of acute ruptures of the anterior cruciate ligament is surgical in some cases with ligamentoplasty technique.

Contrary to the classic ligamentoplasty, the treatment with Ligamys consists of promoting heating of the ligament itself by controlling mechanical environment.

It allows a "dynamic" stabilization of the torn Anterior Cruciate Ligament with in the 3 weekly following traumatism. These techniques may improve the recovery process, proprioceptive results, decrease morbidity of transplant harvesting and faster for the patients. It's all these issues we would like to assess with a randomised multicenter study.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 35 years
* Primary Anterior Cruciate Ligament rupture
* signed patient consent
* surgery 21 days or less after traumatism for Ligamys technique

Exclusion Criteria:

* infection of the operating site
* previous osseous disease
* pregnant or nursing woman.
Testing the Effectiveness of the Her Health Program to Add Healthcare Value in the Fourth Trimester

The goal of this clinical trial is to learn if a program Woman's Hospital has made, called the Her Health Program, can help women be healthy and get healthcare in the first year after having a baby.

The main question\[s\] the study aims to answer are:

* Can the Her Health program increase access to healthcare in the first year postpartum?
* Can the Her Health program increase knowledge about healthcare and change feelings toward the healthcare system?

Participants will complete one research visit in which they will be enrolled and told which group they will be in- "Her Health Program" group or "Usual Care" group. If they are placed in the "Her Health Program" group, they will receive their usual care + the addition of an extra healthcare team member(called a community health navigator) to to work with patients and care team for a year postpartum.

Researchers will compare those who receive the Her Health Program and those who do not receive the program to see if the Her Health Program can help women get healthcare in the first year after having a baby.


Eligibility Criteria:
Inclusion Criteria:

* At least 16 years old at the time of consent.
* Gave birth within 7 days before randomization
* Medicaid enrolled
* Address of residence within a disadvantaged area (ADI\>5).
* Clearly understands the study procedures and visit schedule, alternative treatments, and risks involved with the study, and voluntarily agrees to participate by giving verbal and written informed consent

Exclusion Criteria:

* Use of private health insurance exclusively
* Does not speak English.
* Plans to move out of state during the study time period
* Unwilling to provide permission to link study records, medical records, and Medicaid and Vital Records Database records.
* Unwilling to provide informed consent
* Unwilling to be randomized.
Effectiveness and Safety of 25-Gauge Needle-Assisted Phacoemulsification of Dislocated Intravitreal Lens Nucleus

The goal of this observational study is to learn about the effects of 25-gauge (G) needle-assisted phacoemulsification to remove dislocated intravitreal lens nuclei.

Patients with dislocated intravitreal lens nuclei who underwent 23G pars plana vitrectomy (PPV) and 25G needle-assisted phacoemulsification between July 2022 and September 2024 were included. Primary outcomes included best-corrected visual acuity (BCVA) and intraocular pressure (IOP). Secondary outcomes included corneal endothelial cell count (CECC) and the incidence of intraoperative and postoperative complications. These outcomes were statistically analyzed both preoperatively and postoperatively. A minimum follow-up of 6 months was completed for all eyes.

Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of dislocated intravitreal lens nuclei Signed informed consent

Exclusion Criteria:

Surgical contraindications
An Investigational Study of a Histone Deacetylase (HDAC) Inhibitor Plus Targretin in Cutaneous T-Cell Lymphoma Patients (0683-016)(TERMINATED)

This is an investigational study that increases the dosage to determine the safety/tolerability, and efficacy of a histone deacetylase inhibitor in combination with Targretin in patients with cutaneous T-cell lymphoma in patients who have failed at least one prior systemic therapy.


Eligibility Criteria:
Inclusion Criteria:

* Women or men greater than or equal to 18 years of age
* Advanced cutaneous T-cell lymphoma, stage IB or higher including Sezary Syndrome with progressive, persistent, or recurrent disease
* Failure of at least one systemic therapy, not including Bexarotene (Targretin)
* Eastern Cooperative Oncology Group (ECOG) status less than or equal to 2 (measurement to determine your ability to perform daily activities)

Exclusion Criteria:

* Patient has had investigational treatment in the preceding 30 days
* Active hepatitis B or C, history of HIV
* Prior treatment with any HDAC inhibitor
* Patients must be disease free from prior malignancies for greater than 5 years, except for curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in-situ of the cervix