louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02306499: Outcome of ICSI Using Cryopreserved Testicular Sperm From Infertile Men With Varicocele-associated Azoospermia
Official title: Outcome of ICSI Using Cryopreserved Testicular Sperm From Infertile Men With Varicocele-associated Azoospermia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ICSI AZOOSPERMIA VARICOCELE
Keywords: VARICOCELE-AZOOSPERMIA-ICSI
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 16
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will include cryopreserved sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical \& sonographic), which will be used for ICSI in an ART program in Sohag. Patients personal and medical history and socio-demographic data will be retrieved from their saved medical files.

Detailed description: Study approval: The study will be submitted for approval by Research and Ethical committees at Faculty of Medicine, Sohag University.

This study will include cryopreserved sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical \& sonographic), which will be used for ICSI in an ART program in Sohag .

Patients personal and medical history and socio-demographic data will be retrieved from their saved medical files.

Study design: Prospective, controlled clinical study. Control group: ICSI cases using cryopreserved sperms from infertile azoospermic men due to etiologies other than varicocele. Cases with known female factor infertility will be excluded.

Outcome Measures: fertilization rate, embryo quality, chemical pregnancy and clinical pregnancy.

Eligibility criteria: Inclusion Criteria:

* cryopreserved sperm from infertile azoospermic men, with proven diagnosis of varicocele (clinical \& sonographic), which will be used for ICSI in aى ART program.
* ICSI cases using cryopreserved sperms from infertile azoospermic men due to etiologies other than varicocele.

Exclusion Criteria:

* Cases with known female factor infertility

Primary outcomes:
measure: Clinical pregnancy: documentation of gestational sac and fetal pulsation by transvaginal US 15 days after B-HCG assessment.
timeFrame: 6/2014 up to one year.
Secondary outcomes:
measure: Fertilization Rate: percentage of fertilized oocyte.
timeFrame: 6/2014 up to one year.
measure: Embryo Quality: morphological assessment of the developing embryo.
timeFrame: 6/2014 up to one year.
measure: Chemical pregnancy: B-human chorionic gonadotropin (B-HCG) at day 15 after embryo transfer.
timeFrame: 6/2014 up to one year.
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Ajyal Hospital
Study officials:
affiliation: Sohag University
name: Ramadan Saleh, MD
role: STUDY_DIRECTOR
affiliation: Sohag University
name: Reham Ezz-Eldawla, MD
role: STUDY_DIRECTOR
affiliation: Sohag University
name: Mohamed Yahya, MD
role: STUDY_DIRECTOR
affiliation: Ibn Sina Hospital
name: Muhammed Fawzy
role: STUDY_DIRECTOR
References:
Clinical trial NCT00273299: Valsartan/Hydrochlorothiazide Combination in the Treatment of Severe Hypertension
Official title: A 6-Week Study to Evaluate the Combination of Valsartan/HCTZ (160/12.5mg With Forced Titration to Maximum Dose of 320/25mg) Compared to Valsartan Monotherapy (160mg With Forced Titration to 320mg) as Initial Therapy in Patients With Severe Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: hypertension
high blood pressure
valsartan/hydrochlorozide
severe hypertension
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-01-09
Enrollment: 607
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the potential of using valsartan/HCTZ as initial therapy in patients with severe hypertension compared to valsartan alone as initial therapy, and to determine whether a greater proportion of patients achieve blood pressure control with the combination compared to the monotherapy without producing an unacceptable adverse event profile.


Eligibility criteria: Inclusion Criteria:

* Diagnosed severe hypertension

Exclusion Criteria:

* Inability to discontinue all prior antihypertensive medications
* Heart failure of any kind
* History of stroke, transient ischemic attack, myocardial infarction, chest pain, abnormal heart rhythm Liver, kidney, or pancreas disease
* Diabetes with poor glucose control
* Allergy to certain medications used to treat high blood pressure

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Blood pressure less than 140/90 mmHg after 4 weeks
Secondary outcomes:
measure: Blood pressure less than 140/90 mmHg after 6 weeks
measure: Diastolic blood pressure less than 90 mmHg after 4 and 6 weeks
measure: Systolic blood pressure less than 140 mmHg after 4 and 6 weeks
measure: Change from baseline in systolic and diastolic blood pressure after 4 and 6 weeks
measure: Adverse events and serious adverse events at each study visit for 6 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Calhoun DA, Glazer RD, Pettyjohn FS, Coenen PD, Zhao Y, Grosso A. Efficacy and tolerability of combination therapy with valsartan/hydrochlorothiazide in the initial treatment of severe hypertension. Curr Med Res Opin. 2008 Aug;24(8):2303-11. doi: 10.1185/03007990802271946. Epub 2008 Jun 28.
Clinical trial NCT05144399: Accelerated Treatment of Endocarditis
Official title: Accelerated Treatment of Endocarditis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Endocarditis
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 475
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Existing guidelines recommend a duration of antibiotic treatment of endocarditis of 4-6 weeks one or more types of intravenously administered antibiotics. The long hospitalization increases several risks for the patient, including mental strain and increased loss of function. Furthermore, it poses a significant financial burden on the health systems. Current guidelines fail to use available clinical and paraclinical, data collected from patients (echo, temperature, CRP, leukocytes, procalcitonin etc.) to determine duration of treatment. A strategy including these data in treatment algorithms ensures an individualized treatment, targeting the individual patient's course and response to treatment. Thus, the purpose of this open-label, prospective, non-inferiority, RCT study is to investigate the safety and effectiveness of shortening treatment of endocarditis based on the individual patient's initial treatment response, sampling 475 patients, approx. 125 patients with each type of bacteria (Streptococci; Enterococcus faecalis; Staphylococcus aureus).


Eligibility criteria: Inclusion Criteria:

* Admitted with left-sided infectious endocarditis (duke criteria)
* \< 14 days of relevant antibiotic treatment for endocarditis
* One of the following bacteria: Streptococci, enterococcus faecalis, staphylococcus aureus
* \> 18 years old

Exclusion Criteria:

* Known immune incompetency,
* Relapse endocarditis with 6 months,
* Unable to give informed concent

Primary outcomes:
measure: Combined safety endpoint of: All cause mortality, embolic episodes, not planned Heart surgery
timeFrame: 6 months after randomization
measure: Primary efficacy endpoint: Difference in number of days alive without antibiotic treatment for endocarditits and/or bacteremia between the two study groups
timeFrame: 6 months after randomization
Secondary outcomes:
measure: Expenses associated with admission and treatment
timeFrame: 6 months after randomization
measure: Duration of admission
timeFrame: 6 months after randomization
measure: Duration of antibiotic treatment
timeFrame: 6 months after randomization
measure: Frequency of catheter complication
timeFrame: 6 months after randomization
measure: Unplanned Heart surgery
timeFrame: 6 months after randomization
measure: All cause mortality
timeFrame: 6 months after randomization
measure: Embolic events
timeFrame: 6 months after randomization
measure: Re-bacteremia with the primary pathogen
timeFrame: 6 months after randomization
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshositalet
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
References:
Clinical trial NCT05564299: Rapid Diagnostic Assay for Gonorrhea and Chlamydia
Official title: Impact of a Rapid Test for Gonorrhea and Chlamydia on the Clinical Management of Urethritis and Cervicitis in a Sexual Health Clinic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urethritis
Cervicitis
Sexually Transmitted Infections
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: American Sexually Transmitted Diseases Association
First posted: 2022-10-03
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study is a pilot randomized controlled trial evaluating the use of either a) rapid 30-minute desktop assay or b) point-of-care gram stain (current standard of care) to guide the clinical management of patients with symptomatic urethritis or cervicitis evaluated in the Massachusetts General Hospital Sexual Health Clinic. Patients presenting with symptoms of urethritis or cervicitis and meeting inclusion criteria will be randomized to have diagnostic specimens tested during the clinical encounter using either the 30-minute desktop assay or point-of-care gram stain. Patients randomized to the intervention arm of the study will also have a gram stain created, which will be held for interpretation by the clinician following the clinical encounter. Patients will not be followed longitudinally. Recruitment will conclude when 100 participants enroll in the study.


Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* Presenting with symptoms of acute urethritis or cervicitis
* Willing to provide urine or additional vaginal swab specimen

Exclusion Criteria:

* Younger than 18 years old
* Presenting with symptoms not consistent with urethritis or cervicitis
* Unwilling or unable to provide urine or vaginal swab specimen
* Pregnant
* Contact of index patients with Gonorrhea or Chlamydia
* Known exposure to Gonorrhea or Chlamydia
* Reporting concurrent symptoms at a non-genital site
* Suspected or confirmed to have Monkeypox

Primary outcomes:
measure: Mean number of antibiotic doses administered per patient with symptomatic urethritis or cervicitis
timeFrame: Day 1
Secondary outcomes:
measure: Participant Visit Duration
timeFrame: Day 1
measure: Sample Processing Time
timeFrame: Day 1
measure: Time to result
timeFrame: Day 1
measure: Test-concordant antibiotic use
timeFrame: Day 1
measure: Diagnosis-concordant antibiotic use
timeFrame: Day 1
measure: Rate of invalid test results
timeFrame: Day 1
Other outcomes:
measure: Clinic provider perspectives on rapid STI testing
timeFrame: at study completion: 12 months
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Ingrid V. Bassett, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05156749: Short and Long-arm Fiberglass Cast Immobilization for Distal Salter Harris I and II Forearm Fractures in Children
Official title: Unterarm-Combicast Versus Oberarm-Combicast Bei Gelenknahen Distalen (Salter Harris I/II) Radius- Und Vorderarmfrakturen Im Kindesalter
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fracture Forearm
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2021-12-14
Enrollment: 120
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate whether short-arm fiberglass cast (SAC) immobilization provides fracture stabilization comparable to that of long-arm cast (LAC) treatment of displaced and non-displaced distal Salter Harris I/II forearm fractures in paediatric patients.

Detailed description: The patients are allocated randomly into the two groups(short-arm cast, long-arm cast). After confirming study participation, patients draw a sealed envelope enclosing a numbered card, which assignes them to one group or other. After choosing the envelope, neither the ED staff nor the parents and their childrenare blinded for the treatment groups. However, the data are going to be analyzed under blinded conditions

Eligibility criteria: Inclusion Criteria:

* Salter Harris I or II fracture of the distal radius or a forearm fracture
* informed consent

Exclusion Criteria:

* open/instable/intraarticular fracture
* age \<4 years or \> 16years
* no informed consent

Primary outcomes:
measure: Rate of fracture displacement
timeFrame: in the first four weeks after trauma
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Children's Hospital Zurich
Study officials:
affiliation: University Children's Hospital, Zurich
name: Michelle Seiler, PD
role: STUDY_CHAIR
References:
Clinical trial NCT00238849: Phase II Study of Oxaliplatin and Navelbine for Second-Line Treatment of Advanced NSCLC.
Official title: Phase II Study of Oxaliplatin in Combination With Navelbine for the Second-Line Treatment of Advanced and Metastatic Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Previously Treated Metastatic Non-Small Cell Lung Cancer
Keywords: Non-small cell lung cancer
Lead sponsor: Integrated Community Oncology Network
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2005-10-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the response rate to treatment with oxaliplatin and Navelbine in patients with previously treated NSCLC. Oxaliplatin and Navelbine have not been clinically evaluated yet. However, Navelbine has been safely administered with other platinum compounds.

Detailed description: This is a non-randomized trial for patients with previously treated Non-small cell lung cancer. Each patient will receive 6 cycles of chemotherapy consisting of Oxaliplatin and Navelbine. Oxaliplatin is given intravenously every 21 days and Navelbine is administered Intravenously on day 1 and day 8 every 21 days.

Eligibility criteria: Inclusion Criteria:

* Locally advanced or metastatic non-small cell lung cancer that has recurred, progressed, or failed to respond to previous systemic chemo.
* Measurable disease
* Good performance status (ECOG 0,1 or 2)

Exclusion Criteria:

* Previously treated with Oxaliplatin or Navelbine
* Symptomatic CNS metastases

Primary outcomes:
measure: Efficacy
Secondary outcomes:
measure: Time to progression
measure: Duration of response
measure: Survival
measure: Toxicity profile
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Integrated Community Oncology Network
state: Florida
city: Orange Park
country: United States
facility: Integrated Community Oncology Network
state: Florida
Study officials:
affiliation: Integrated Community Oncology Network
name: Thomas A Marsland, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03217149: Heliox for Neonate With Acute Respiratory Distress Syndrome (ARDS)
Official title: Heliox for Neonate With Acute Respiratory Distress Syndrome (ARDS): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ARDS
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
First posted: 2017-07-13
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute respiratory distress syndrome (ARDS) in neonates has been defined, the role of heliox is not clear.This study aimed to determine whether ARDS neonate would benefit from heliox when oxygenation deteriorated on mechanical ventilation and to identify any potential risk factors related to mortality.

Detailed description: Acute respiratory distress syndrome (ARDS) can result in severe hypoxemia refractory to mechanical ventilation, mechanical ventilation including high frequency oscillation ventilation is the main method. But it is partial unuseful.

Eligibility criteria: Inclusion Criteria:

1. infant less than 28 days
2. diagnosis of ARDS
3. informed parental consent has been obtained

Exclusion Criteria:

1. major congenital malformations or complex congenital heart disease
2. transferred out of the neonatal intensive care unit without treatment

Primary outcomes:
measure: death
timeFrame: within 100 days
Secondary outcomes:
measure: Bayley Scales of Infant Development
timeFrame: at 2 months old and 2 years old
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Department of Pediatrics, Daping Hospital, Third Military Medical University
state: Chongqing
Study officials:
affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
name: Shi Yuan, PhD,MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05109949: Acute Effect of Empagliflozin vs Dapagliflozin Over Pulse Wave Velocity in Type Two Diabetes
Official title: Acute Effect of Empagliflozin vs Dapagliflozin vs Placebo Administration Over Pulse Wave Velocity in Patients With Type Two Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetes Mellitus Type 2 Without Complication
Lead sponsor: Centro Universitario de Ciencias de la Salud, Mexico
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 72
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To date one of the main independent biomarkers of cardiovascular disease is the arterial stiffness parameters measured by carotid-femoral pulse wave velocity. It is known that SGLT2 inhibitors develop cardiac protection over long term administration, but there's not enough studies about acute effects in early administration.

Detailed description: Measure basal carotid-femoral Pulse Wave Velocity through a Pulse Pen tonometer by DiaTecne among basic physical examination, blood test, anthropometric and hemodynamic measurements; then administrate randomly dapagliflozin 10 mg, empagliflozin 25 mg or placebo for 7 days and then perform all of the measurements and blood test again.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of T2DM
* HbA1c \> 7 y \< 10
* BMI 25 - 34.9 kg/m2
* Signature of consent under information

Exclusion Criteria:

* Hypertension
* Treated with insulin and / or loop diuretics and thiazides
* T1DM
* Hypotension
* Any autoimmune disease
* Liver disease
* Women whitout birth control method
* Women taking oral birth control or under hormone replacement therapy
* Woman pregnant or breastfeeding
* Untreated thyroid disease
* Patients with a cardiovascular disease that contraindicates the use of this pharmacological class
* Glomerular filtration rate \<60ml/min (Cockcroft-Gault)

Primary outcomes:
measure: Pulse wave velocity
timeFrame: 7 days
Secondary outcomes:
measure: Fasting plasma glucose
timeFrame: 7 days
measure: Total cholesterol
timeFrame: 7 days
measure: Triglycerides
timeFrame: 7 days
measure: High-density lipoprotein cholesterol
timeFrame: 7 days
measure: Low-density lipoprotein cholesterol
timeFrame: 7 days
measure: Creatinine
timeFrame: 7 days
measure: Blood pressure
timeFrame: 7 days
Other outcomes:
Locations:
city: Guadalajara
country: Mexico
facility: Institute of Experimental and Clinical Therapeutics (INTEC), CUCS, University of Guadalajara
state: Jalisco
Study officials:
affiliation: Institute of Experimental and Clinical Therapeutics (INTEC), CUCS
name: Fernando Grover-Páez, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01187849: Metformin to Prevent Metabolic Complications in Glucocorticoid Excess
Official title: Metformin to Prevent Metabolic Complications in Glucocorticoid Excess
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Patients With Glucocorticoid Treatment
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2010-08-24
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate if a treatment with metformin compared to placebo reduces metabolic side-effects in patients with glucocorticoid treatment over three months time.


Eligibility criteria: Inclusion Criteria:

* Glucocorticoid treatment for ≥ 3 months with a prednisone dose of ≥ 7.5mg/d or equivalent glucocorticoid

Exclusion Criteria:

* Refusal of informed consent
* Prior therapy with metformin during the last 6 month
* Preexisting diabetes
* Pregnancy or current malignancy
* Renal insufficiency with a creatinine clearance lower than 30ml/min

Primary outcomes:
measure: 2 hours glucose level after a standardized 75g oral glucose tolerance test (OGTT)
timeFrame: 0 months, 3 months
Secondary outcomes:
measure: homeostasis model assessment (HOMA)-index
timeFrame: 0 months, 3 months
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
state: Basel-Stadt
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Mirjam Christ-Crain, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References: