louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01210326: The Comparison of Diagnostic TESE and TESA in Non-obstructive Azoospermic
Official title: The Comparison of Diagnostic Testicular Sperm Extraction(TESE) and Testicular Sperm Aspiration(TESA) in Non-obstructive Azoospermic Patients a Randomized Clinical Trial Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Infertility
Keywords: TESE
TESA
non obstructive
azoospermi
Lead sponsor: Royan Institute
Sponsor class: OTHER_GOV
First posted: 2010-09-28
Enrollment: 180
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Azoospermia , as the name suggests , refers to the condition in which there are no sperm in the semen. This diagnosis can come as a rude shock, because most men with a zero sperm count have normal libido; normal sexual function; and their semen looks completely normal too. The diagnosis can only be made by examining the semen under a microscope in the laboratory.Men with non-obstructive azoospermia have a normal passageway, but abnormal testicular function, and their testes do not produce sperm normally. Some of these men may have small testes on clinical examination. The testicular failure may be partial, which means that only a few areas of the testes produce sperm, but this sperm production is not enough for it to be ejaculated. Other men may have complete testicular failure, which means there is no sperm production at all in the entire testes. The only way to differentiate between complete and partial testicular failure is by doing multiple testicular micro-biopsies to sample different areas of the testes and send them for pathological examination. This technique is called TESA, or testicular sperm aspiration ( also known as TESE, or testicular sperm extraction) or mTESE ( micro-testicular sperm extraction).

Detailed description: This study was performed on 180 men with non-obstructive azoospermia (NOA), referring to royan infertility center, according to inclusion and exclusion criteria. Testis selection (right and left) and techniques (TESE or TESA) were performed randomly in patients. For every patient based on random order, TESA or TESE was performed as the following procedures. The testis was aspirated at three separated sites (upper, middle and lower pole), using 20 ml syringe and 18-gauge needle or testicular biopsy (TESE) was taken from the same 3 sites.

Eligibility criteria: Inclusion Criteria:

* Non obstructive Azoospermia
* No Previous biopsy

Exclusion Criteria:

* Atrophic testis
* FSH levels more than 4 times normal range

Primary outcomes:
measure: Sperm retrieval
timeFrame: 6 months
Secondary outcomes:
measure: Side effects
timeFrame: 6 months
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Royan Institute
Study officials:
affiliation: President of Royan Institute
name: hamid gourabi, PhD
role: STUDY_CHAIR
affiliation: urology investigator
name: Jalil Hosseini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05649826: Automated Ultrasound Cardiac Guidance Tool
Official title: Optimization of an Ultrasound Cardiac Guidance Tool
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ultrasound Imaging
Lead sponsor: UltraSight
Sponsor class: INDUSTRY
First posted: 2022-12-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 200 subjects will be enrolled in this study, at least 35% females and 35% males.

Brief summary: This research examines echocardiography images taken from cardiac patients in relation to the guidance tool developed

Detailed description: The study is an open label, single arm prospective study. This goal of the study is to learn about echocardiography images in relation to the developed guidance tool software in cardiac patients population. Participants will undergo one session of transthoracic echocardiography exam. The ultrasound will be performed by a sonographer for images acquiring purposes

Eligibility criteria: Inclusion Criteria:

1. Males and females, aged 18 years and older
2. Subject willing and able to give written informed consent

Exclusion Criteria:

1. Emergency (non-elective) admission within 24 h prior to participating in the study
2. Female subjects who are pregnant (women of childbearing potential will provide a statement that they are not pregnant incorporated in the ICF
3. Unable to lie as required in all the classic positions for standard TTE exam: supine on back / left decubitus
4. Subjects who currently participate in a clinical trial, involving interventional cardiac devices.
5. Subjects who have prior Echo exam with description of Low/Poor quality exam in the echo report.
6. Subjects with BMI above 40.
7. Subjects experiencing a known or suspected acute cardiac event.
8. Subjects with severe chest wall deformity as per previous medical records and physical examination.
9. Subjects who have undergone pneumonectomy.
10. Subjects whose anatomy does not lend itself to yield diagnosable standard echocardiography clips (i.e., situs inversus with dextrocardia, single ventricle anatomy due to congenital heart disease, etc.).

Primary outcomes:
measure: Acquisition of transthoracic echocardiography media from up to 200 subjects
timeFrame: up to 5 year
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Wayne University
state: Michigan
Study officials:
affiliation: Wayne University Emergency medicine
name: Robert Ehrman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: UltraSight
name: Noa Avisar, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06159426: Expert vs. Non-expert Abdominal Electromyographic Control in Vojta Therapy
Official title: Electromyographic Response Control in the Application of Vojta Therapy in the Abdominal Muscles of Healthy Young Adults: Expert vs Non-expert Comparison
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Abdominal Muscles
Keywords: Electromyography
Muscle Contraction
Expert Therapist
Outcome and Process Assessment
Health Care
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Randomized clinical trial on a cohort of healthy subjects of legal age, of both sexes, recruited from the university community and who will be randomly distributed into two groups (expert therapist vs. non-expert therapist). The objective will be to determine if there are differences in the muscular activation produced on the stabilizing muscles of the trunk (external oblique and internal oblique) if it is applied by an expert therapist versus if it is applied by a therapist not specialized in therapy and to know the effects produced on the muscles studied after performing the intervention.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old.
* Full cognitive capacity.

Exclusion Criteria:

* Subjects with neuro-muscular pathologies that affect the abdominal muscles, previous surgeries in the area or any chronic neurological or organic disorder that may alter the results.
* Vaccinated in the 10 days prior to the intervention
* Fever

Primary outcomes:
measure: Electromyographic activity in abdominal muscles
timeFrame: Change from Baseline electromyographic activity at 7 minutes.
Secondary outcomes:
measure: Date of birth
timeFrame: Baseline
measure: Sex
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03357926: Prospective Database for Prediction of Atrial Fibrillation in Pacemaker and ICD Patients
Official title: SAFE-ME - Prospective Database for Prediction of Atrial Fibrillation in Pacemaker and ICD Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atrial Fibrillation
Pacemaker Ddd
ICD
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2017-11-30
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with an implanted dual-chamber Pacemaker or an implantable cardioverter Defibrillator

Brief summary: Atrial fibrillation (AF) is associated with a five-fold increased risk of cerebrovascular stroke. While the risk of stroke in patients with known AF can be calculated via AF stroke prediction risk scores, the prediction of AF occurrence per se in individual patients remains difficult.

We will recruit 250 patients with an implanted dual-chamber Pacemaker (PM) or an implantable cardioverter Defibrillator (ICD) with atrial lead to ensure continuous rhythm monitoring during follow up. At baseline, we will gather clinical and device data of patients. For AF prediction based on surface Electrocardiography (ECG), 24-h Holter ECG monitoring will be performed. After 6 months, we will assess the occurrence of AF during the study period via interrogation of PM/ICD. The resulting data will be used to develop algorithms including clinical, device and ECG data for prediction of the development of AF in individual patients. If possible, we will develop a risk score of high accuracy by combination of demographical, clinical and technical parameters of device patients. The resulting risk score could potentially help to facilitate the decision if anticoagulation is necessary in patients with either risk of AF or embolic stroke of unknown origin. Furthermore, Hayn et al. (AIT Austrian Institute of Technology) are currently developing algorithms to predict the occurrence of AF surface ECG data. It is an additional aim of this project to support the development of this algorithm in pacemaker and ICD patients and to increase the accuracy of AF prediction with clinical parameters and other parameters available to patients with implanted pacemaker (PM) or implanted cardioverter-defibrillator (ICD).


Eligibility criteria: Inclusion Criteria:

* Implanted pacemaker or implanted cardioverter defibrillator (ICD) with atrial lead
* CHADS-VASc Score of 2 or more
* Sinus rhythm or atrial paced rhythm
* Atrial stimulation rate 50% or less
* ModeSwitch rate 50% or less since last pacemaker interrogation

Exclusion Criteria:

* pacemaker or ICD malfunction
* atrial fibrillation (AF) at time of pacemaker / ICD interrogation
* AF during 24-hour Holter ECG monitoring
* permanent AF

Primary outcomes:
measure: Frequency of occurrence of atrial high rate episodes
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
References:
Clinical trial NCT00832026: Trans Nasal Insufflation for the Treatment of Snoring
Official title: Trans Nasal Insufflation for the Treatment of Snoring and Obstructive Sleep Apnea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: sleep apnea
snoring
sleep apnea treatment
TNI
Trans nasal insufflation
Open CPAP
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2009-01-29
Enrollment: 11
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People with obstructive sleep apnea are eligbile to participate in this study.

Brief summary: This research is being done to examine if a nasal cannula can be used to keep the throat open during sleep, thereby treating sleep apnea.

People with sleep apnea and people who snore without sleep apnea may take part in this study. Sleep apnea is a disorder caused by pauses in breathing due to repetitive closure of the throat. The most common form of treatment for sleep apnea is continuous positive airway pressure (CPAP) therapy. While CPAP therapy remains the simplest and most effective treatment for snoring and sleep apnea, patients have to wear a nasal mask throughout the night. For this reason, patients often have difficulty sticking to therapy.

Participants enrolled in this study will spend 3-nights in a sleep laboratory. In all nights, the investigators will monitor your sleep and your breathing throughout the night. The investigators will apply several electrodes (sensors) to your scalp and face to monitor your sleep and breathing, and other sensors to your chest, abdomen, cheek, and a finger to monitor your breathing and oxygen level.


Eligibility criteria: Inclusion Criteria:

* Consenting adults over the age of 21
* Diagnosed obstructive sleep apnea

Exclusion Criteria:

* Unstable cardiovascular disease
* Uncontrolled hypertension (BP \> 190/110)
* Severe intrinsic lung diseases (supplemental O2 \> 2 L/min during the day)
* History of chronic renal insufficiency
* History of hepatic insufficiency
* Pregnancy
* Bleeding disorders or Coumadin use
* Sleep Disorders other than Obstructive Sleep Apnea (OSA)
* Tracheostomy
* Allergy to lidocaine

Primary outcomes:
measure: Change in inspiratory airflow
timeFrame: 2 nights
Secondary outcomes:
measure: Change in sleep apnea severity (AHI)
timeFrame: 2 nights
measure: Change in Ratio of apnea-to-hypopnea events
timeFrame: 2-nights
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
References:
citation: McGinley BM, Patil SP, Kirkness JP, Smith PL, Schwartz AR, Schneider H. A nasal cannula can be used to treat obstructive sleep apnea. Am J Respir Crit Care Med. 2007 Jul 15;176(2):194-200. doi: 10.1164/rccm.200609-1336OC. Epub 2007 Mar 15.
Clinical trial NCT01762826: Myo-inositol, D-chiro-inositol, and D-chiro/Myo-inositol in Gestational Diabetes
Official title: Adverse Obstetric Outcomes in Gestational Diabetes Mellitus and Inositol Stereoisomears
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: GDM
Keywords: Inositol
GDM
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
Collaborators: name: University of Chieti
First posted: 2013-01-08
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Non obese pregnant women during first trimester of pregnancy with scared fasting glucose (above 92 mg%)

Brief summary: Comparison of different inositol stereoisomears in preventing adverse obstetric outcomes in non-obese pregnant women at high risk for gestational diabetes mellitus.

Detailed description: The investigators compared outcomes from metabolic and obstetric point of view in GDM pregnant non-obese patient with different stereoisomears of inositol supply. Dietary control and placebo or inositol steroisomears were administered starting at the enrolling time (first fasting oral glucose above 92 mg%; usually before 20 weeks gestations') till the delivery and/or pregnancy end/termination. Oral glucose tolerance test results at 24-28 weeks' gestation was evaluated (as glucose values and oGTT screening). Fetal growth, delivery data, obstetric outcomes and necessity of insulin therapy were taken into account.

Eligibility criteria: Inclusion Criteria:

* pregnancy below 20 weeks gestation BMI below 30 Fasting glucose between 92 and 126 mg% Singleton pregnancy Naturally conceived

Exclusion Criteria:

* obese patient Fasti g glucose above 126 or below 92

Primary outcomes:
measure: OGTT result
timeFrame: 24-28 weeks' gestation
Secondary outcomes:
measure: Fetal measurements at third trimester
timeFrame: 28 weeks
measure: Delivery data
timeFrame: 25-42 weeks gestations'
measure: Adverse obstetric outcome
timeFrame: from first elevated oral fasting glucose (above 92 mg%) till the end/termination of pregnancy (latter 42 weeks gestation)
Other outcomes:
Locations:
Study officials:
affiliation: ObGyn Dept University of Chieti
name: Claudio Celentano, MD
role: STUDY_DIRECTOR
affiliation: ObGyn Dept Univ of Chieti
name: Barbara Matarrelli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Diabetology Dept Univ of Chieti
name: Ester Vitacolonna, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02793726: The Effects of Large Head MoM Hip Prosthesis on Soft Tissue: Study With 3 Tesla NMR
Official title: The Effects of Large Head Metal on Metal (MOM) Hip Prosthesis on Soft Tissue: Study With 3 Tesla Nuclear Magnetic Resonance (NMR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostheses and Implants
Keywords: Hip Prosthesis
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2016-06-08
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients wearing MoM (Metal on Metal) hip prosthesis, head \>= 36 mm

Brief summary: Symptomatic and asymptomatic patients wearing Metal on Metal hip prosthesis will be enrolled in the study and periimplant pseudotumors will be searched by means of NMR (Nuclear Magnetic Resonance).


Eligibility criteria: Inclusion Criteria:

* Patients wearing MoM hip prosthesis
* Head \>= 36 mm

Exclusion Criteria:

* Presence of ferromagnetic implants and/or presence of clinical situations that are not compatible with NMR

Primary outcomes:
measure: Presence of pseudotumor
timeFrame: at first NMR, between 3 and 6 yrs from surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli - Laboratorio Tecnologia Medica
Study officials:
References:
Clinical trial NCT06588426: Clinical Readiness Skin Punch Biopsy Sample Collections
Official title: Clinical Readiness Skin Punch Biopsy Sample Collection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Heart Disease (CHD)
Congenital Heart Defect
Keywords: CHD
Congenital Heart Defect
Lead sponsor: HeartWorks, Inc.
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Congenital heart disease patients likely to qualify in the future for treatment using iPSC-CL in an approved clinical trial under IND 28611

Brief summary: This is a clinical readiness skin punch biopsy sample collection study. This will allow to reduce manufacturing time when patients are identified as eligible to receive product under separate interventional treatment protocol.

Detailed description: This is a clinical readiness skin punch biopsy sample collection study. This will allow to reduce manufacturing time when patients are identified as eligible to receive product under separate interventional treatment protocol.

Eligibility criteria: Inclusion Criteria:

* Age 18 and older
* Congenital heart disease
* Likely to qualify for an active clinical trial under IND 28611 in the future

Exclusion Criteria:

* Previous cardiac transplantation
* Unable or unwilling to consent
* HIV diagnosis
* Hepatitis diagnosis

Primary outcomes:
measure: Successful manufacture of induced pluripotent stem cells
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
Clinical trial NCT01047826: M.I.P.O. vs Intramedullary Nailing in Tibia Fractures
Official title: Intramedullary Nailing vs. M.I.P.O. in Fractures of the Tibia a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tibia Fracture
Keywords: Fractured Tibia
Expert Tibial Nail
Minimally Invasive Plate Osteosynthesis (M.I.P.O)
Intramedullary Nailing
Locked Plate
distal third
43-A
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
First posted: 2010-01-13
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators are comparing two methods of standard treatments in distal tibial fractures. locked plating (M.I.P.O. technique) with intramedullary nailing.

the investigators are hypothesizing that M.I.P.O group is superior to nailing in fractures of the distal third of the tibia.

Detailed description: The kind of plates the investigators are comparing are the Locked plates form Synthes ® using the minimally invasive technique vs the Expert Tibial Nail® from Synthes ®

Eligibility criteria: Inclusion Criteria:

* Males and Females aged from 18-60 years
* Closed Tibia Fracture
* Tibia Fracture Müller AO Class 43-A

Exclusion Criteria:

* Intra-articular Fractures
* Open fractures
* fracturesSubjects with documented Marfan's syndrome or Ehlers-Danlos syndrome or Hajdu-Cheney syndrome.
* Post organ transplant patients (except Cornea transplant)
* Subjects on immunosuppressive medications
* Subjects with diagnosed with

  * Osteogenesis imperfecta
  * Osteopetrosis
  * Paget disease of bone
  * Renal osteodystrophy
* Subjects with diagnosed neoplasms or mitotic illnesses
* Subjects receiving growth hormone
* Unable to comply with postoperative rehabilitation e.g. head injury
* Impending compartment syndrome

Primary outcomes:
measure: Rate Of Malunion
timeFrame: 6 months
Secondary outcomes:
measure: The Short Form (12) Health Score (SF-12v2®)
timeFrame: every 3 months till healing or 24 months
measure: Blood Loss
timeFrame: during the time of surgery
measure: Radiation exposure
timeFrame: During the time of Surgery
measure: Duration of Surgery
timeFrame: During the time of Surgery
measure: Infection Rate
timeFrame: every 3 months till healing or 24 months
measure: Hospital Stay
timeFrame: After Surgery
measure: Time Of Fracture Healing
timeFrame: 6 months
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Abdullah International Medical Research Center
state: Central
Study officials:
affiliation: National Guard Heath Affaires, Saudi Arabia
name: Husam A AL-Rumaih, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Guard Health Affairs
name: Wael S Taha, MD
role: STUDY_DIRECTOR
affiliation: National Guard Health Affairs
name: Sami I AL-Essia, MD
role: STUDY_CHAIR
References: