cyrilzakka/clinical-trials huggingface dataset:
Do Text Message Reminders Increase Preoperative Exercise in Obesity Surgery Candidates?

Preoperative exercise has been shown to improve physiological and functional capacity in patients undergoing abdominal surgery to prepare them for the stress of surgery. Patients undergoing bariatric surgery are advised to partake in regular preoperative exercise. In the setting of bariatric surgery, as well as preparing patients for the stress of surgery, it is also thought to increase the likelihood that they will exercise postoperatively. However, compliance to this advice is extremely low. Text-message interventions have been shown to improve compliance to other lifestyle interventions. The investigators will compare the rate of compliance to preoperative exercise prior to bariatric surgery in patients who receive a daily text message to those who do not. The investigators will also compare weight loss.


Eligibility Criteria:
Inclusion Criteria:

* Patients having laparoscopic sleeve gastrectomy at Manukau Surgery Centre
* Operation used primarily for the treatment of morbid obesity

Exclusion Criteria:

* Operation not performed at Manukau Surgery Centre
* Patient does not have a mobile phone which can receive text messages
Retrospective Patient Satisfaction Survey in Subjects With Tecnis Intra Ocular Lenses and Cataracts Surgery

Define what factors correlate with higher degrees of patient satisfaction and dissatisfaction among patients who have recently undergone cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients with uncomplicated bilateral cataract surgery with a Tecnis Multifocal or monofocal implant completed at least 60 days before the survey date.
* Patient with and without astigmatic keratotomy will be included.

Exclusion Criteria:

* Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their satisfaction with surgery
* Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.)
* Patients with ≥ grade 1 posterior capsule opacity at their last visit
Metabolic Syndrome Observation on a Regional Basis

The aim of the study is to assess the prevalence of Metabolic Syndrome in Italy on a regional basis, defined according to NCEP/ATPIII Guidelines criteria.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged between 18 and 75 years
* Signed Informed consent
* Laboratory analysis (lipidic profile and glycemia) performed in the last year

Exclusion Criteria:

* Pregnancy or breast feeding
* Patients enrolled in clinical studies which the aim is to evaluate the efficacy and/or tolerability of anti-hypertensive and/or lipid lowering drugs
* Subjects with serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's successful participation in the study
Retrieval of Sperm from Men with Azoospermia Using Ultrasound-guided Rete Testis Aspiration

The objective of this study is to use ultrasound-guided rete testis flushing and aspiration technique to retrieve sperm, non-surgically, from the testes of azoospermic men. If sperm are retrieved by this method, it will provide a direct benefit to the infertile men. This protocol will also establish the safety and feasibility of the ultrasound-guided rete testis injection approach in consenting men before the approach is translated to teenage boys.

The aim of this study is to demonstrate that ultrasound-guided rete testis aspiration is a safe and effective method to flush and aspirate rare sperm from the testes of men with azoospermia (no sperm in the ejaculate). Current methods to recover sperm from men with azoospermia range from invasive and time consuming micro testicular sperm extraction (microTESE) to fine needle aspiration (FNA), which is less invasive and less time consuming, but also less effective because it is a blind approach. This approach is less invasive; it involves the percutaneous insertion of a hypodermic needle into the rete testis space. This approach is also not blind because the needle is accurately positioned under ultrasound guidance into the rete testis space that is contiguous with all seminiferous tubules (where sperm are made). The investigators will first perform the experimental ultrasound-guided rete testis flushing and aspiration on both testis. If sperm is found, no standard of care procedure (TESE, microTESE etc) will be performed. If sperm is not found, the participant can choose whether or not to proceed with a standard of care procedure. In cases were participants have previously tried a standard of care procedure, they may not want to do that again if the experimental procedure does not work. For the ultrasound-guided rete testis flushing and aspiration, the investigators will flush and aspirate the tubules with 500ul of physiological saline and Optison ultrasound contrast agent in sterile 0.9% saline (routinely used in clinics). Presence of sperm in the aspirate will be determined. The investigators hypothesize that sperm recovery using the ultrasound-guided rete testis injection/aspiration approach will at least as effective as the standard of care approach employed in the Magee male fertility clinic and it will be less invasive.

Eligibility Criteria:
Inclusion Criteria:

* Be a male over the age of 18
* Be diagnosed with azoospermia
* Have 2 testicles
* Sign an approved consent and authorization permitting the release of personal health information. The patient must acknowledge in writing that consent for sperm collection has been obtained, in accordance with institutional policies approved by the U.S. Department of Health and Human Services.

Exclusion Criteria:

* Diagnosed with psychological, psychiatric, or order conditions which prevent giving fully informed consent
* Diagnosed with underlying medical condition that significantly increases their risk of complications from this procedure
Popliteal Artery Entrapment Syndrome & TRanscutaneoUS Oxymetry

Aim of the study is to test the feasibility of transcutaneous oxygen pressure (TcPO2) recording in the diagnosis of popliteal entrapment syndrome (PES) in 30 patients with suspected PES and 30 asymptomatic control heathy subjects

Patients suspected of PES and healthy cpontrols after detailled explanation of the protocol will have a recording of tcpO2 on both calves and will perform a series of elevation on foot in the standing position.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Insurance company alffiliation Symptoms consistent with PES (patients) or absence of symptoms (controls)

Exclusion Criteria:

* Refuse to participate Exclusion period from another protocole
A Study Comparing Tretinoin Gel Microsphere, 0.1% and RETIN-A MICRO ® Gel Microsphere, 0.1% in the Treatment of Acne Vulgaris

To demonstrate the therapeutic equivalence and safety of Tretinoin Gel Microsphere, 0.1% (Taro Pharmaceuticals U.S.A, Inc.) and RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1% (Valeant) in the treatment of acne vulgaris.

A multi-center, double-blind, randomized, placebo controlled, parallel-group study, comparing Tretinoin Gel Microsphere, 0.1% (Taro Pharmaceuticals U.S.A, Inc.) and RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1% (Valeant) in the treatment of acne vulgaris.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
* Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. Subjects ages 12 to 17 years of age, inclusive, must have provided IRB approved written assent
* Subjects must have a definite clinical diagnosis of acne vulgaris of severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA)

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
* Subjects with a history of hypersensitivity or allergy to tretinoin, retinoids, or any of the study medication ingredients.
* Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
Toi Même: a Mobile System for Measuring Bipolar Illness

Bipolar disorder is a severe psychiatric illness with chronic course and it is associated with high risk of relapse and hospitalisation, and many patients do not recover to their previous psychosocial functioning. Major reasons for poor outcomes are delayed intervention for prodromal mood and behavioural symptoms as well as incomplete treatment responses. Current diagnostic approaches used to assess mood symptoms rely on symptom-based categories, which lack sensitivity to detect subtle mood and behavioural changes. Therefore, the ability to better characterizing bipolar patients may allow to detect possible differences in the illness activity.

On the other hand, there is a growing interest in the potential use of mobile technologies such as mobile apps, smartphone and internet in psychiatric care. Some projects have been testing the potential benefits of mobile apps to assess and treat individuals at-risk or suffering from mood and bipolar disorders, using online signs and symptoms monitoring, yet to the investigators knowledge, none of them have integrated a dimensional approach in a smartphone app to assess mood and behavioural alterations and bipolar illness activity, including subjective and objective data (e.g. physical activity, social activity, etc.).

In this feasibility study the investigators will evaluate the potential relevance of Toi Même app to self-monitoring mood and behavioural changes in bipolar patients with different mood phases compared to the gold-standard mood rating tools used in clinical practice. All patients will be followed for 3 months, with outcome assessments after 2 weeks, after 1 month, 2 months and after 3 months.


Eligibility Criteria:
Inclusion Criteria:

* patients with the current diagnosis of Bipolar disorder type I or type II according to the DSM-5 criteria
* having an iPhone with iOS version from 9.x with access to wireless Internet connectivity.

Exclusion Criteria:

* Current DSM-5 diagnosis of schizophrenia, psychotic disorders, dementia, or mental retardation.
* Active suicidal ideation or behaviours.
The Genetic Basis for Vulnerability to Substance Abuse

This investigation seeks to better define the genetic basis for vulnerability to substance abuse.

Dopamine (DA), a neurotransmitter helping to mediate reward and reinforcement, has been putatively linked to the development of substance abuse, alcohol abuse, and alcoholism. Identification of specific vulnerability-association alleles for receptors, other molecules within the reward mediating system, and other genes that may predispose individuals to the development of such disorders is the goal of the study.

This investigation will help elucidate the genetic underpinnings of substance abuse, potentially leading to the improved methods to diagnose those at risk and to help develop better therapeutic interventions.

Eligibility Criteria:
Inclusion Criteria:

* Substance abusers
* Allow for blood draw

Exclusion Criteria:

* Cognitively impaired
A Phase 1 Study of Givosiran (ALN-AS1) in Patients With Acute Intermittent Porphyria (AIP)

The purpose of this study is to evaluate the safety and tolerability of givosiran (ALN-AS1) in AIP patients as well as to characterize pharmacokinetics (PK) and pharmacodynamics (PD) of ALN-AS1 in AIP patients.


Eligibility Criteria:
Parts A and B

Inclusion Criteria:

* Diagnosis of AIP
* Urine PBG at Screening indicating patient is a high excreter
* No clinically significant health concerns
* Women of child bearing potential must have a negative pregnancy test, not be nursing, and use effective contraception
* Willing to provide written informed consent and willing to comply with study requirements.

Exclusion Criteria:

* Porphyria attack within 6 months of screening
* Started a new prescription medication within 3 months of screening
* Clinically significant abnormal laboratory results
* Received an investigational agent within 90 days before the first dose of study drug or are in follow-up of another clinical study
* History of multiple drug allergies or intolerance to subcutaneous injection

Part C

Inclusion Criteria:

* Diagnosis of AIP
* Patient experienced a porphyria attack or was taking medication to prevent attacks recently
* No clinically significant health concerns
* Women of child bearing potential must have a negative pregnancy test, not be nursing, and use effective contraception
* Willing to provide written informed consent and willing to comply with study requirements.

Exclusion Criteria:

* Stared a new prescription medication within 3 months of screening
* Clinically significant abnormal laboratory results
* Received an investigational agent within 90 days before the first dose of study drug or are in follow-up of another clinical study
* History of multiple drug allergies or intolerance to subcutaneous injection
A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise

During this study, your child will need to attend up to 5 office visits and maintain regular telephone contact with the clinic. Certain office visits will include physical exams, medical history review, exercise challenge test (walking/running on a treadmill), electrocardiogram (ECG) tests, and lung function tests. All study related medications and medical examinations are provided at no cost. All study drugs are currently available by prescription to patients 4 years and older.


Eligibility Criteria:
Inclusion criteria:

* Diagnosed with persistent asthma for 3 months or longer.
* Experienced worsened asthma symptoms during physical activity.
* Using an inhaled steroid for the previous 4 weeks or longer (such as Aerobid, Azmacort, Flovent, Pulmicort, QVAR, and Vanceril).

Exclusion criteria:

* Used systemic steroids as either liquids, pills, or injections to treat asthma within the previous 3 months.
* Have only intermittent, seasonal, or exercise-induced asthma, and not persistent asthma.
* Admitted to a hospital within the previous 6 months due to asthma symptoms.
* Any poorly controlled medical conditions that may make study participation unsafe or inappropriate in the opinion of the study physician (such as cystic fibrosis, congenital heart disease, insulin dependent diabetes, glaucoma, drug allergies, etc.)
* The study physician will evaluate other medical criteria.
To Evaluate the Use of Radiomics to Classify Between Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease

To investigate the ability of machine learning models based on radiomic features extracted from thin-section CT images to differentiate IPF patients from non-IPF interstitial lung diseases.


Eligibility Criteria:
Inclusion Criteria:

* UIP with final diagnosis in biopsy
* ILDs with final diagnosis in biopsy

Exclusion Criteria:

* patients with no biopsy confirmation
The Effect of Cinnamon Extract on Insulin Resistance Parameters in Polycystic Ovary Syndrome: A Pilot Study

The purpose of this study is to determine whether oral cinnamon extract are effective in reducing insulin resistance parameters in women with polycystic ovary syndrome.

Polycystic ovary syndrome (PCOS) is a very common condition found in women of childbearing age. PCOS patients often have irregular periods, extra hair growth, or difficulty becoming pregnant. The syndrome can also be associated with more serious conditions such as heart disease, diabetes, or cancer of the uterus.

Although no one knows the cause of the syndrome, scientific studies showed that having too much insulin can be one of the reasons. In fact, almost every overweight woman with PCOS has been found to have high insulin levels.

Medications that lower the body's insulin level used to treat people with diabetes mellitus have also been used very successfully to treat some of the symptoms of PCOS such as irregular periods.

Recently studies using rats and mice have shown that a commonly used spice, cinnamon, may also reduce the body's insulin level. Another study showed that daily use of cinnamon for forty days lowered the blood sugar level in patients with diabetes. The purpose of this study is to see if cinnamon can lower the insulin level in women with PCOS. If so, it can also be used as a treatment for irregular periods as well.

Half of the patients in the study will take premade cinnamon extract pills twice a day while the other half will take placebo pills (pills with no cinnamon extract) twice a day for eight weeks. Blood tests measuring insulin, substances important for insulin action, cholesterol, and glucose (sugar) will be taken before and after the eight weeks of medication. A total of three separate visits will be needed to finish the study. At the end of the study, we will then compare the blood glucose, insulin, and cholesterol levels between the patients that took cinnamon and the patients that took placebo.

Eligibility Criteria:
Inclusion Criteria:

* Polycystic ovary syndrome

Exclusion Criteria:

* Diabetes mellitus, hyperprolactinemia, thyroid disorders, and hypertension
Clinical Translation of a Novel Albumin-Binding PET Radiotracer 68Ga-NEB

This is an open-label whole-body PET/CT study for investigation of radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and diagnostic performance of 68Ga-NEB in healthy volunteers and patients with suspected infection. Changes of routine blood and urine tests and any adverse events will be collected from the volunteers. Adverse events will also be observed in the patients.

The labeling of albumin has advantages as drawing blood is unnecessary and the operator labeling is not exposed to potentially infectious material. Evans blue (EB) dye has high affinity for serum albumin, The final obtained products NEB (a NOTA conjugate of a truncated form of Evans blue for in vivo albumin labeling) was proceeded strict quality controls.

No fasting, hydration or other specific preparation was requested on the day of imaging.

Patients for blood pool imaging underwent whole-body PET/CT acquisitions 30-45 min after intravenous injection of 111-148 MBq (3-4 mCi) 68Ga-NEB with each bed position lasted for 2 min and a standard routine 18F-FDG PET/CT within one week.

Patients for lymph node imaging including the breast nodules patients underwent a standard routine 18F-FDG PET/CT first, and were locally injected 10\~20MBq 68Ga-NEB, followed by dynamic chest regional PET acquisitions.

A Siemens MMWP workstation was used for post-processing. Visual analysis was used to determine the general biodistribution and the temporal and intersubject stability. Semiquantitative methods were applied for image analysis.

Eligibility Criteria:
Inclusion Criteria:

* Must be able to provide a written informed consent
* Males and females, ≥18 years old；
* Diagnostic CT or MRI suggesting a diagnosis of liver focal lesion(s). In suspicion of arteriovenous malformations. Newly diagnosed breast cancer and lymph node metastasis is not clear. The tumor will be surgically removed and histological diagnosis will be available. Evaluation of cardiac function.

Exclusion Criteria:

* Females planning to bear a child recently or with childbearing potential；
* Known severe allergy or hypersensitivity to IV radiographic contrast；
* Inability to lie still for the entire imaging time because of cough, pain, etc.
* Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.
* Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.
Oxytocin Administration Prior Planned Caesarean Section

Spontaneous vaginal delivery of a healthy infant provokes a unique surge in stress hormone concentrations (e.g. AVP (arginine vasopressin) /copeptin) incommensurable with child or adult levels measured in any other situation. In contrast, infants delivered by primary caesarean section without preceding labour have low stress hormone concentrations at birth unless other stressors are present, including chorioamnionitis or intrauterine growth restriction. Infants delivered by caesarean section after a trial of labour show copeptin concentrations between these two extremes.

Objectives:1) To reduce neonatal respiratory morbidity and admission to the Neonatal Intensive Care Unit and increase bonding and breastfeeding by triggering uterine contractions prior to planned caesarean delivery.

2) To collect prospectively weight data of infants in the first 6 months of life to validate and expand our online neonatal weight calculator.

Study design: Open label; randomised, placebo controlled trail Intervention: Oxytocin challenge test (OCT): Infusion of oxytocin 5 IU/500 ml Ringer® lactate at a rate of 12 ml/h and doubled every 10 min until three uterine contractions per 10-min interval are induced, at which point it will be stopped.

Primary endpoint:

- Incidence of neonatal respiratory morbidity

Secondary endpoints:

* Umbilical cord blood copeptin levels
* Postnatal neonatal weight change
* Breastfeeding status


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy \>34 weeks
* primary caesarean section, that is without preceding contractions or rupture of the membranes,
* absence of a contraindication to oxytocin

Exclusion Criteria:

* Chromosomal aberration
* malformation,
* IUGR,
* Nonreassuring fetal heart rate pattern,
* Placenta praevia,
* maternal substance abuse,
* infections,
* hypertension,
* preeclampsia,
* diabetes type I or II,
* autoimmune disease (antiphospholipid syndrome, lupus erythematosus, etc.),
* renal disease,
* history of more than one previous caesarean section.