cyrilzakka/clinical-trials huggingface dataset:
Intra Testicular Artery Injection of Bone Marrow Stem Cell in Management of Azoospermia

Azoospermia due to low sperm production (non-obstructive azoospermia) affects approximately 1% of the male population and 10% of men who seek fertility evaluation. Testis biopsy reveals that these men have Sertoli cell-only pattern, maturation arrest, or hypospermatogenesis. Until recently, it was assumed that men with non-obstructive azoospermia were untreatable. Indeed, these patients were often referred to as being "sterile" or having "testicular failure." We start to use stem cell in treatment of such patients by injecting the stem cell at the testis and the testicular artery in one group and at the testis only in other group


Eligibility Criteria:
Inclusion Criteria:

- Azoospermia

Exclusion Criteria:

- Absent or surgical removed testes
A Study of LY3457263 Alone and in Combination With Dulaglutide (LY2189265) in Participants With Type 2 Diabetes

The main purpose of this study is to investigate the safety and tolerability of the study drug LY3457263 when administered alone or in combination with glucagon-like peptide 1 (GLP-1) receptor agonist (RA) in participants with type 2 diabetes. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. The study will last up to approximately 16 weeks excluding the screening period for each participant and include up to 17 visits.


Eligibility Criteria:
Inclusion Criteria:

* Participants with type 2 diabetes (T2D) at least 6 months before screening
* Participants treated for T2D with diet and exercise, with or without metformin
* Have a glycated hemoglobin A1c (HbA1c) value of ≥ 7.5% and ≤10.5%
* Have had a stable body weight for 3 months and body mass index (BMI) of 27.0 to 45.0 kilograms per meter squared (kg/m²)
* Male participants who agree to use effective methods of contraception and female participants not of childbearing potential

Exclusion Criteria:

* Have a history of or current cardiovascular, respiratory, hepatic, renal, GI, endocrine (apart from T2D), hematological, or neurological disorders capable of altering the absorption, metabolism, or elimination of drugs
* Have type 1 diabetes mellitus or latent autoimmune diabetes in adults or maturity-onset diabetes of the young
* Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy
* Have known allergies to GLP-1 receptor agonists
SOCKNLEG Compression Stocking Kit: Physical Properties

This study evaluates physical properties of a innovative leg compression stocking compared to a standard compression stocking of the same compression strength in patients with chronic venous insufficiency clinical stadium C3 and above, according to the CEAP classification for chronic venous insufficiency.

The physical properties can be measured through a series of measurements. The hypothesis is that the innovative compression stocking, although changed in design to be more easily donned, will perform as good as the standard compression stocking.

In each participant the examinations will be conducted with both stockings. A computer generated list will allocate each participant to either one of the stockings, with which the examinations will be conducted first.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent as documented by signature
* Male or post-menopausal women over the age of 65
* Diagnosed chronic venous insufficiency stage C3-C6 (according to CEAP classification)
* Indication of a compression therapy by medical compression stocking

Exclusion Criteria:

* Peripheral artery disease (PAD) or calcinosis (Ankle-Brachial-Index \<0.8 or \>1.3
* Suspected polyneuropathy with ≤4 sensible test areas measured with the Semmes- Weinstein-Monofilament-Test
* Advanced heart insufficiency (NYHA III-IV)
* Contraindications to compression therapy
* Known allergies to any components of the stocking material
* Inability to follow the procedures of the study
Investigation of 9 Consecutive Remicade Infusions in Ankylosing Spondylitis in Austria (Study P04044)(COMPLETED)

This is a prospective, open-label, 1-arm, multicenter observational study to determine the dose and time span of Remicade between infusions for ankylosing spondylitis (AS).

This study population was chosen from a non-probability sample.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with ankylosing spondylitis with severe axial symptoms and elevated serological markers of inflammatory activity.

Exclusion Criteria:

* Subjects with tuberculosis or other severe infections such as sepsis, abscesses, and opportunistic infections.
* Subjects with moderate or severe heart failure (New York Heart Association (NYHA) class III/IV).
* Subjects with a history of hypersensitivity to Remicade or to other murine proteins, or to any of the excipients.
Clinical Investigation of an Improved Two-piece Stoma Product for People Living With a Stoma

Open-label, randomized, controlled, comparative, cross-over study with 2 test sequences comparing a new 2-piece coupling system with SenSura Mio Click.

It will be a 1:1 randomization into the two possible treatment sequences

Each test period is 3 weeks (± 2 days), total study period is 6 weeks (± 4 days).

All visits will be performed as remote virtual calls. At the visits, the investigator will give instructions for the coming period and check that the trial is running as planned. At every bag change the subject will be asked to complete a questionnaire.

A follow-up call will be scheduled 7±1 days after each test visit to ensure compliance with the provided product and study procedures. Additional calls may be scheduled if needed.

Minimum 40 participants will be enrolled and randomized.

Eligibility Criteria:
Inclusion Criteria:

1. Has given written consent to participate by signing the Informed Consent Signature Form
2. Be at least 18 years of age and have full legal capacity
3. Is able to handle (apply, remove, cut, etc.) the product and do the assessments themselves
4. Has an ileostomy or colostomy with consistent liquid fecal output (for colostomy: 6-7 Bristol stool scale)
5. Currently use SenSura Mio Click 2p Click flat or concave with 50 mm coupling size
6. Have had their ostomy for at least 90 days
7. Be willing to change the bag at least twice per week
8. Is willing and suitable (determined by the Principal Investigator or designee) to use flat or concave 2p open product during the investigation
9. Is willing to use 2p maxi open bags during the investigation

Exclusion Criteria:

1. Is currently receiving or have within the past 60 days received radio-and/or chemotherapy

   - Low doses radio- and/or chemotherapy (assessed by Principal Investigator) is allowed for indications other than cancer.
2. Is currently receiving or have within the past 30 days received topical steroid treatment in the peristomal skin area, e.g., lotion or spray

   * Low dose systemic steroid treatment (e.g., inhalation) assessed by the investigator are allowed.
   * Other systemic steroid treatment (e.g., injection or tablet) are not allowed.
3. Is pregnant and/or breast-feeding
4. Have a loop ileostomy
5. Is currently using convex baseplate
6. Has known hypersensitivity towards any of the products used in the investigation
Biventricular Epicardial Pacing Post Cardiac Surgery in Patients With Left Ventricular Ejection Fractions Less Than 45%

Patients with reduced left ventricular function are at an increased perioperative risk and often need prolonged postoperative treatment on intensive care units. A significant portion of these patients require postoperative pacing. Right ventricular pacing has been shown to be hemodynamically deleterious The aim of this study is to determine which biventricular pacing after cardiac surgery, in patients with reduced left ventricular function (EF≤ 45%), is hemodynamically favourable.

Some patients with left ventricular systolic dysfunction (LVSD) have an inefficient pumping function. These patients have been shown to benefit from a device therapy known as biventricular pacing. Biventricular pacing causes a more coordinated contraction of the heart chambers resulting in improvement in the pumping ability of the heart and blood pressure. Cardiac Resynchronization Therapy (CRT) has established itself as a proven therapy for congestive heart failure in adults, patients showing improvement in exercise tolerance, quality of life, and survival.

In cardiac surgery, a significant number of these patients with left ventricular systolic dysfunction require postoperative pacing. Right ventricular pacing has been shown to be hemodynamically deleterious Whether biventricular pacing in patients with LVSD improves patient outcomes after heart surgery has not been investigated.

The aim of this crossover trial is to compare conventional ventricular pacing and DDD-biventricular in post operative patients with a pre operative ejection fraction less than 45%, in a prospective randomized setting.

We would like to determine whether biventricular pacing optimized by trans thoracic echocardiography of left ventricular, immediately after heart surgery in patients with LVSD will improve the heart function.

Immediately after surgery, the patients will receive atrio ventricular conventional right ventricular pacing, or biventricular pacing depending upon the treatment arm that they were randomized to.

The primary end point is a 15 % improvement in index cardiac measured by thermal dilution and/or echocardiography in intensive care unit.

Furthermore, Plasma N-terminal pro-brain natriuretic peptide (NT-proBNP), cardiac troponin T (cTnT), will be measured in patients undergoing elective cardiac surgery 12 h, 24 h, 48 h and 72 hours after.

This study is important because of a high probability of clinical benefit.

Eligibility Criteria:
Inclusion Criteria:

* Planned CABG and/or valve surgery
* Left ventricular dysfunction (EF≤ 45%)
* Age \> 18 years
* able to give written information consent

Exclusion Criteria:

* Existing permanent pace maker
* Atrial fibrillation
* Enrolment in other research protocols
* Inability to give written informed consent
* Heart transplant
* Pre operative cardiovascular instability
The ProGirls Study

Girls in the juvenile justice system who have high rates of delinquency, drug abuse, and trauma are particularly at risk for engaging in risky sexual behavior and for contracting HIV/AIDS or other sexually transmitted infections (STIs). No effective prevention programs for girls who have this combination of behaviors is known to exist at this time. Researchers are developing, assessing, and implementing a family-centered prevention program to decrease girls' participation in the risky behaviors associated with the spread of HIV and STIs. The program also includes a group-based training and support program for parents.

This study aims to test an intervention to reduce HIV/STI risk behavior among girls in the juvenile justice system with the triple-threat risk of delinquency, drug abuse, and trauma. This is a competing continuation of the ProTeens study (Preventing Drug Abuse \& HIV/AIDS in Delinquent Youths: An Integrated Intervention) which focused on testing a family-centered intervention for treating HIV risk, drug use, and delinquency in boys. The current study will adapt the ProTeens intervention for girls. Girls and their parent(s) will be randomly assigned to either a family-centered intervention condition (INT; n = 100) or to an active comparison condition (n = 100) consisting of group therapy and case management (GCM). The INT condition will consist of individually administered HIV preventive intervention for adolescent girls involved in the juvenile justice system that integrally addresses delinquency, drug abuse, and trauma exposure, along with group-based training and support for parents. The girl and parent components will run concurrently for three months. The GCM condition will consist of group therapy and case management for girls provided as usual by the juvenile justice department. We will examine intervention effects on proximal outcomes measured at 12 months, the effects of childhood adversity on proximal outcomes, and the mediation of intervention effects. Longer term outcomes will be measured at 24 months. Data will be collected through in-person interviews and questionnaires from focal participants and their parents, official arrest records, and urinary analysis.

Eligibility Criteria:
Inclusion Criteria:

* female, age 13-18 years
* living in Lane County, Oregon
* living at home (biological/adoptive, foster, or other relative care)
* at least one criminal referral and on probation or a formal accountability contract with the juvenile justice system
* documented drug use from juvenile justice risk assessment
* traumatic exposure
* no imminent plans to be placed in out-of-home care

Exclusion Criteria:

* meet criteria for posttraumatic stress disorder
The Effects of a Very Low Carbohydrate Diet Intervention on Weight Control in Overweight/Obese Patients in China

The study was designed to investigate the effects of a very low carbohydrate diet (VLCD) intervention on weight control in overweight/obese patients in China.All the subjects were randomly assigned to experiment group and control group. The experimental group was given individual instructions on how to follow the VLCD (very low carbohydrate diet). The control group was given an energy-restricted diet.The energy-restricted diet (ER diet) was designed in the traditional Chinese style with an initial target for a total energy intake of 1200 kcal/d (5021 kJ/d).

121 obese or overweight patients were enrolled in the study and 23 patients were dropped out (43 male, 55 female, aged≥18 years, BMI≥24 kg/m2) from the outpatient clinic of endocrinology and metabolism department of Southern Medical University Affiliated ZhuJiang Hospital. All the subjects were randomly assigned to experiment group and control group. The experimental group was given individual instructions on how to follow the VLCD (very low carbohydrate diet). Energy intake was restricted to less than 800kcal/day (3349kJ/d) (carbohydrate intake \< 20g/d). All daily meals were replaced as follows: a cup of soybean milk (200 mL) and a boiled egg at breakfast; a diet nutrition bar (106 Kcal: 2.8 g carbohydrate, 11.2 g protein and 5.6 g fat; Nutriease Health Technology Co., Ltd., Hangzhou, China), nonstarchy vegetables (\<200 kcal), and 50 g protein from meat (i.e., beef, lean pork, skinned chicken, fish) at lunch and dinner. Supplementation of multivitamins and minerals was provided per day. The energy-restricted diet (ER diet) was designed in the traditional Chinese style with an initial target for a total energy intake of 1200 kcal/d (5021 kJ/d). Subjects were also encouraged to drink at least 1.8 litres of water per day, and asked to maintain their habitual level of physical activity. Compliance with the diet and physical activity level was checked at weekly visits.

Eligibility Criteria:
Inclusion Criteria:

* overweight or obese healthy volunteers (43 male, 55 female, aged≥18years, BMI≥24 kg/m2)

Exclusion Criteria:

* pregnant or plan for pregnant
* lactation or postmenopausal women
* use of any prescription medication in previous 2 months
* had any weight loss diet or pill during the past 6 months
* consuming\>20 g/day of alcohol
* tobacco use within 6 month
* cardiovascular or endocrine disease history
* hypertension history or current elevated blood pressure (systolic blood pressure (SBP): ≥150 mmHg; diastolic blood pressure (DBP)≥90 mmHg; current treatment for hypertension)
* diabetes mellitus
* acute or chronic infections
* hepatopathy, kidney disease, gastrointestinal disease or any other acute or chronic diseases requiring treatment.
Clinical Outcome of Pacemaker paTIents According to Pacing Modality and Primary INDications

The study objective is to collect mid-term clinical outcome in a group of patients implanted with permanent pacemaker (PM) according to real-life clinical practice in a multicenter and international environment.

The principal objective of the OPTI-MIND study is to collect data on two-year all-cause mortality in a general population implanted with a PM according to current clinical practice. Additionally, the study aims to stratify the outcome by both known patient-related risk factors and by physiologic pacing mode setting (a specifically defined PM programming). Stratification will be done for pre-specified classes of patients on the basis of their primary rhythm disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients implanted with a current Boston Scientific pacemaker (all ALTRUA models) or any future commercially available Boston Scientific PM families according to international and local guidelines for pacemaker implantation;
* Patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational centre;
* Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.

Exclusion Criteria:

* Unable to be followed up by the participating centres for a period of two years;
* Current device implanted for more than 15 days;
* Women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion);
* Patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry or extensions/amendments of the current protocol. Each instance should be brought to the attention of the sponsor to determine eligibility.
Physical Therapists Identifying Patients With Opioid Misuse

The purpose of this study is to develop and operationalize key procedures for physical therapists (n = 12) to address patients who are at risk for or have opioid misuse (OM). The investigators will train physical therapists in procedures to: 1) engage patients at risk for OM in conversations about appropriate opioid use, 2) screen and 3) assess these patients for OM and, 4) refer patients for further treatment if OM is suspected. The investigators will employ a modified Delphi approach to iteratively refine and operationalize the procedures and to arrive at a finalized procedure manual followed by an evaluation of the implementation of these procedures.

The purpose of this study is to develop and operationalize key procedures for physical therapists (n = 12) to address patients who are at risk for or have OM. The investigators will train physical therapists in procedures to: 1) engage patients at risk for OM in conversations about appropriate opioid use, 2) screen and 3) assess these patients for OM and, 4) refer patients for further treatment if OM is suspected. The investigators will employ a modified Delphi approach to iteratively refine and operationalize the procedures and to arrive at a finalized procedure manual followed by an evaluation of the implementation of these procedures. Approximately 4 months following the development of the manual and the distribution of the finalized manual, the investigators will conduct semi-structured interviews to determine the barriers and facilitators to implementing the procedures learned in the training.

Our aims are:

1. Qualitatively evaluate physical therapists' perceptions and recommendations for implementing OM procedures.
2. Evaluate the implementation of the manualized OM procedures.

Eligibility Criteria:
Inclusion Criteria:

* University of Utah physical therapists with at least 0.5 full-time equivalent
* Self report managing patients with musculoskeletal pain

Exclusion Criteria:

* None
Short Course Radiation Therapy in Palliative Treatment of Complicated Bone Metastases

Aim of the study is to assess efficacy of a short course radiation treatment in patients with complicated bone metastases

Standard treatment for complicated bone metastases (3000 cGy in 10 daily fractions of 300 cGy each) is compared with experimental treatment (4000 cGy in 4 fractions of 500 cGy twice a day) to demonstrate non-inferiority of this scheme.

Eligibility Criteria:
Inclusion Criteria:

* complicated bone metastases from any solid tumor
* age \>18 years
* ECOG performance status 0-3
* symptomatic lesion (NRS \>1)
* no changes in analgesic treatment at least in the week before radiotherapy

Exclusion Criteria:

* pregnancy
* previously irradiation of the same region
Comparison of Pulse Wave and Blood Pressure Measurements Before, During and After Ergometry in Healthy Women

The objective of this randomized, controlled single blind study is to compare pulse wave and blood pressure measurements before, during and after exercise ergometry in healthy female subjects.

In a randomized single-blind study design the investigators explore how well blood pressure parameters calculated using a Pulse Transit Time-based method (device: SOMNOtouchTM RESP) match blood pressure parameters measured by a classic upper arm blood pressure cuff (BOSO-TM-2430 ) under standardized load conditions (ergometry).

In 30 healthy female subjects (age 18 - 40 years), cardiovascular parameters before, during and after a standardized load on a bicycle ergometer (half-lying position) are recorded with three different devices (BOSO-TM-2430 versus SOMNOtouchTM RESP versus GeTeMed Vitaguard 3100) and compared.

Primary outcome is the difference of the systolic blood pressure values between the devices BOSO-TM-2430 versus SOMNOtouchTM RESP during the three phases.

The BOSO-TM-2430 blood pressure cuff is applied randomized to the arm with the previously determined higher or lower systolic blood pressure mean difference. The subjects are blinded to the results of the measurements during ergometry.

After a pre-rest period of 12 minutes, the subjects are physically strained on the ergometer for 48 minutes (6 minutes loading phase followed by a 2-minute rest phase; 30 watts increase every 8 minutes up to a maximum load of 180 watts), followed by a 12-minute rest period. Measurements are taken every two minutes with the BOSO-TM-2430; data acquisition with the SOMNOtouchTM RESP and GeTeMed Vitaguard 3100 devices takes place continuously over a total duration of 72 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Healthy at the time of the examinations
* Inconspicuous anamnesis regarding cardiovascular diseases and bronchial asthma
* resting heart rate 50 to 100 beats per minute
* Normal blood pressure or appropriately treated and controlled hypertension (systolic blood pressure ≤ 140 mmHg and diastolic blood pressure ≤ 90 mmHg)

Exclusion Criteria:

* Acute or chronic (especially cardiovascular) diseases, including cardiac arrhythmia and vegetative regulatory disorders (recorded via anamnesis)
* Taking allopathic medication: digitalis, beta blockers, antiarrhythmics
* Bronchial asthma (recorded by anamnesis)
* Alcohol abuse
* Heart diseases NYHA class IV
* Blood pressure side difference ≥ 10mmHg
* Fever (\> 37,5°C)