louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01833793: Descriptive, Prospective, Non-interventional Study (NIS) to Describe Mirena and Amenorrhea Related Acceptability in Contraception Indication in Medical Practice
Official title: Mirena and Amenorrhea Related acceptabILity in Contraception indIcAtion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Female Contraception
Keywords: Mirena
Contraception
Amenorrhea
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-04-17
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who have been prescribed Mirena for contraception.

Brief summary: MARILIA is a prospective, non-interventional, multicenter study. The purpose of this study is to describe the acceptability of Amenorrhea in contraception indication of Mirena users during one year follow up in medical practice. 500 patients in 20 centers will be enrolled in the study. Bleeding profile, removal or non-removal of the IUS (IntraUterine System) will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Age 19-40 years at the time of Mirena IUD insertion
* Using Mirena only for contraception indication
* Never having used the product before
* No heavy menstrual bleeding diagnosed
* Have signed informed consent to participate in this study

Exclusion Criteria:

* Nulliparous
* Pregnancy
* Mirena's contre-indication
* Mirena for HMB
* Abnormal bleeding pattern

Primary outcomes:
measure: Proportion of Mirena users who have at least one period of Amenorrhea of at least three months
timeFrame: 12 months
measure: Cumulative incidence rate of Amenorrhea over the duration of follow up period in Mirena users
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of Mirena users who have menstrual disorders
timeFrame: 12 months
measure: Proportion of Mirena users with menorrhagia
timeFrame: 12 months
measure: Cumulative rate of satisfaction in Mirena users
timeFrame: 12 months
Other outcomes:
Locations:
city: Many Locations
country: Algeria
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01250093: Acupuncture Compared With "Sham" Acupuncture for Treatment of Chronic Neck Myofascial Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Neck Myofascial Pain Syndrome
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2010-11-30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: In order to investigate the therapeutic effect of acupuncture on chronic neck myofacial pain syndrome, the investigaotrs designed a pilot study of a single-blind randomized controlled trial. A total of 34 chronic neck myofacial pain syndrome patients were selected from Department of Neurology of Nantou Hospital, Department of Health. The age ranged from 18 to 85, and all subjects were full informed consent and volunteers. They were divided into two groups of 17 subjects randomly as follows: acupuncture group, acupuncture stainless needles were inserted into bilateral Fenhchi, Jianliao and Houxi acupoints, respectively. The acupuncture needles then were manual twist and de Qi, and remain for 20 min; sham acupuncture group, the methods were identical the acupuncture group, but acupuncture stainless needles were inserted into subcutaneous tissue only. All the subjects were treated with acupuncture two times per week and continuously three weeks, i.e. Six times acupuncture treatment. The therapeutic effect of acupuncture was assessed before and finishing six times acupuncture treatment, and four weeks and twelve weeks after stopping acupuncture, respectively. The index of acupuncture therapeutic effect was according to the range of motion (ROM) of the cervical spine, the intensity of pain (Short-Form McGill Pain Questionnaire; SF-MPQ) and quality of life (SF-36). The investigators expect acupuncture apply to bilateral Fenhchi, Jianliao and Houxi acupoints may relief the pain and motion of chronic neck facial pain syndrome patient, and also improves the life quality.


Eligibility criteria: Inclusion Criteria:

* 18-85 year-old patients with neck myofascial pain for more than one month; not received any treatment in the two weeks before participating this study

Exclusion Criteria:

* Fracture or surgery of the cervical spine; Cervical radiculopathy or myelopathy; Any rheumatic disorder; Systemic disorders; Major psychiatric disorder, alcoholism or substance abuse; Coagulation dysfunction, or related medicines; Pregnancy; Contraindications to acupuncture; Refused to sign consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05670093: Neural Pressure Support, Synchrony and Respiratory Muscle Unloading
Official title: Neural Pressure Support, a Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Respiratory Failure
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Interventional prospective study. Each participant is ventilated both on PS and NPS at 3 different support levels.
Primary purpose: TREATMENT

Brief summary: In this study patients who are intubated and on ventilator for more than 24h will be ventilated at three different level of support in Pressure Support and Neural Pressure Support to study patient-ventilator synchrony and muscle unloading.

Detailed description: This study is an interventional randomized crossover study in intubated and mechanically ventilated patients for more than 24h. Eligible patients from whom informed consent is obtained and Pes and Edi catheter are successfully positioned are enrolled in the study. Patients will be ventilated in Pressure Support and Neural Pressure Support at three different level of assist (baseline, 50% and 150% of baseline respectively) in randomized order. Ventilator curves will be recorded and bloodgas obtained at the end of each study step, each lasting 20min.

Eligibility criteria: Inclusion Criteria:

-Patients intubated for more than 24 hours in the weaning phase from the ventilator.

Exclusion Criteria:

* bleeding disorders (PK INR\>1,5 or APTT\>50s or platelet count \<50000/µL)
* unstable circulation (requiring high vasopressor dose, for example Noradrenalin \>0,2µg/kg/min)
* severe lung disease (PFI ≤ 13,3 kPa)
* fever\> 38,5°C
* pregnancy.

Primary outcomes:
measure: Patient-ventilator asynchronies
timeFrame: 20 minutes ventilatory traces recording
Secondary outcomes:
measure: respiratory muscle unloading
timeFrame: 20 minutes ventilatory traces recording
Other outcomes:
Locations:
city: Solna
country: Sweden
facility: Karolinska University Hospital
Study officials:
affiliation: Department of Molecular Medicine and Surgery, Karolinska Institutet, Stockholm, Sweden.
name: Francesca Campoccia Jalde
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05642793: Effect of Postvitrectomy Proactive Use of Conbercept on Postoperative Complications in PDR Patients
Official title: Effect of Postvitrectomy Proactive Use of Conbercept on Postoperative Complications in PDR Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Proliferative Diabetic Retinopathy
Keywords: vitrectomy
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is an unmasking randomized clinical trial. the main purpose of this study is to analyze whether posvitrectomy proactive use of conbercept can reduce the rate of postoperative complication in PDR patients.


Eligibility criteria: Inclusion Criteria:

* PDR patients undergoing vitrectomy

Exclusion Criteria:

* patients who had received intravitreal injection or systemic use of all types of anti-VEGF agents in the recent three months before vitrectomy
* patients who had received intravitreal injection or systemic use of all types of steroid in the recent one month before vitrectomy
* patients who had received complete PRP before vitrectomy
* patients who are pregnant

Primary outcomes:
measure: rate of postvitrectomy complication
timeFrame: 6 months
Secondary outcomes:
measure: postvitrectomy BCVA
timeFrame: 6 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Huijin Chen, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02852993: Survival After Blood Transfusion in the French Administrative Regions of Burgundy and Franche-Comté
Official title: Survival After Blood Transfusion in the French Administrative Regions of Burgundy and Franche-Comté
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erythrocyte Transfusion for All Conditions
Keywords: Erythrocyte Transfusion
Survival
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire Dijon
name: Etablissement Français du Sang
First posted: 2016-08-02
Enrollment: 16099
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The eligible patients consisted of all adult patients transfused for the first time (defined as patients with no known history of RBC unit use in the transfusion register), at the university hospitals of Besançon or Dijon, between January 2007 and December 2011.

Brief summary: Red blood cell transfusion (RBC) is the main symptomatic treatment for severe anemia. RBC transfusion has proven its efficacy regarding mortality and morbidity, but it is not without side effects. The infectious side effects of transfusion are largely considered under control, non-infectious side effects are taking center stage. Seeking explanations for the beneficial and deleterious effects of RBC transfusions is necessary to ensure the safe and optimal use of this precious resource.

The investigators aim to study the impact of donor and RBC characteristics on patient survival.


Eligibility criteria: Inclusion Criteria:

* Aged 18 and over
* Erythrocyte Transfusion between 2007 and 2011
* Performed at the University Hospital of Besançon or Dijon

Exclusion Criteria:

* Transfusion of any blood product prior to January 1st, 2007

Primary outcomes:
measure: Survival
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre d'Investigation Clinique, CHU de Besançon
city: Dijon
country: France
facility: Département d'information Médicale, CHU Dijon
Study officials:
affiliation: Centre d'Investigation Clinique; CHU Besançon
name: Maxime Desmarets, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Desmarets M, Bardiaux L, Benzenine E, Dussaucy A, Binda D, Tiberghien P, Quantin C, Monnet E. Effect of storage time and donor sex of transfused red blood cells on 1-year survival in patients undergoing cardiac surgery: an observational study. Transfusion. 2016 May;56(5):1213-22. doi: 10.1111/trf.13537. Epub 2016 Mar 2.
Clinical trial NCT01347593: Prophylactic Ceftizoxime (Cefizox) for Elective Cesarean Delivery
Official title: Prophylactic Ceftizoxime (Cefizox) for Elective Cesarean Delivery in Soba Hospital Sudan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Caesarean
Keywords: ceftizoxime
Cesarean
post caesarean febrile morbidity
Lead sponsor: University of Khartoum
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Sudan
First posted: 2011-05-04
Enrollment: 220
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ceftizoxime (Cefizox) will reduce post Cesarean delivery febrile morbidity.


Eligibility criteria: Inclusion Criteria:

* Elective Cesarean section

Exclusion Criteria:

* Diabetes severe anaemia allergy

Primary outcomes:
measure: reducing post Cesarean section febrile morbidity
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Khartoum
country: Sudan
facility: Soba Hospital
Study officials:
References:
citation: Osman B, Abbas A, Ahmed MA, Abubaker MS, Adam I. Prophylactic ceftizoxime for elective cesarean delivery at Soba Hospital, Sudan. BMC Res Notes. 2013 Feb 8;6:57. doi: 10.1186/1756-0500-6-57.
Clinical trial NCT00584493: Treatment Use Study for Advanced Melanoma.
Official title: Treatment Use Study of CP-675,206 for Advanced Melanoma
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Advanced Unresectable Melanoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-01-02
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to provide access to CP-675,206 for patients with advanced unresectable melanoma and who have the potential to gain benefit from this treatment and who are not eligible for participation in other CP-675,206 studies.

Detailed description: This is an expanded access trial that canceled prior to enrolling patients.

Eligibility criteria: Inclusion Criteria:

* Advanced melanoma with life expectancy of at least 6 months.
* Melanoma must be considered unresectable.
* Patients with stable, treated brain mets must be stable clinically and radiographically and off steroids for at least one month.

Exclusion Criteria:

* Patients must not be eligible for participation in any ongoing CP-675,206 clinical studies currently open for enrollment.
* History of chronic inflammatory or autoimmune disease.
* History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea, active colitis, history of diverticulitis.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00952393: Nicotinic Receptors and Schizophrenia
Official title: Nicotinic Receptors and Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: receptors nicotinic
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-08-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study determines if a new preparation of a drug designed to treat schizophrenia is more slowly released into the body.

Detailed description: 3-2,4 dimethoxybenzylidene will be compounded with a methyallose compound in doses of 150 and 300 mg. The capsules will be administered singly and eventually bid to determine if sustained blood levels comparable to steady state blood levels seen in previous studies can be determined. Safety and EEG effects will be measured.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers: males and females who are incapable of pregnancy

Exclusion Criteria:

* Medical illnesses requiring acute treatment
* History of seizures
* Substance abuse including nicotine

Primary outcomes:
measure: Blood Levels of Drug
timeFrame: 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: VA Eastern Colorado Health Care System, Denver
state: Colorado
Study officials:
affiliation: VA Eastern Colorado Health Care System, Denver
name: Robert Freedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06902493: Impact of Prior SGLT2 Inhibitors Use on the Development and Progression of Sepsis-Associated Acute Kidney Injury
Official title: Impact of Prior Sodium-Glucose Co-Transporter 2 Inhibitor Use on the Development and Progression of Sepsis-Associated Acute Kidney Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Septic Shock
Acute Kidney Injury
Keywords: Sepsis
Acute Kidney Injury
Sepsis-associated acute kidney injury
SGLT2i
Lead sponsor: University of Jazan
Sponsor class: OTHER_GOV
First posted: 2025-03-30
Enrollment: 664
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult (≥ 18 year) patients who were admitted to ICU with sepsis syndromes (sepsis or septic shock), according to sepsis-3 definition.

Brief summary: The primary objective of this study is to investigate whether using SGLT2i may be associated with decreased incidence of sepsis-induced AKI or not.

Detailed description: The primary objective of this study is to investigate whether using SGLT2i may be associated with decreased incidence of sepsis-induced AKI or not.

Eligibility criteria: Inclusion Criteria:

* All adult (≥ 18 year) patients who were admitted to ICU with sepsis syndromes (sepsis or septic shock), according to sepsis-3 definition.

Exclusion Criteria:

* Missing data
* Renal transplant or tumor
* Solitary kidney
* Established CKD
* Obstructive uropathy
* Renal artery stenosis
* Pregnancy

Primary outcomes:
measure: Odds of sepsis-associated acute kidney injury (AKI) in patients with prior use of SGLT2 inhibitors (SGLT2i)
timeFrame: The exposure window for SGLT2i use will be defined as any use within 90 days prior to the onset of sepsis. The outcome (sepsis-associated AKI) will be evaluated during the index hospitalization for sepsis.
Secondary outcomes:
measure: ICU length of stay
timeFrame: During ICU stay (from ICU admission to discharge), Maximum 6 months stay
measure: The need for RRT
timeFrame: During ICU stay (from ICU admission to discharge), Maximum 6 months stay
measure: 28-day mortality
timeFrame: Up to day-28 from ICU admission
Other outcomes:
Locations:
city: Al 'Usaylah
country: Saudi Arabia
facility: King Fahd Central Hospital
Study officials:
affiliation: Armed Forces Hospitals, Southern Region, Saudi Arabia
name: Mohammed Alshrahili, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03090893: Response of Continuous Recombinant Antithrombin Infusion in Postcardiotomy ECMO Patients
Official title: A Pilot Study, Prospective, Non-Randomized, Non-Blinded, Single-Center Study Evaluating the Response of Continuous Recombinant Antithrombin (ATryn) Infusion in Postcardiotomy ECMO Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Antithrombin Deficiency Type 2
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: rEVO Biologics
First posted: 2017-03-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this study will be to prospectively evaluate the response of a continuous infusion of recombinant human antithrombin concentrate (rhAT) (ATRYN®) to achieve and maintain the AT activity within a specified range in adult patients that require extracorporeal membrane oxygenation (ECMO) following cardiopulmonary bypass (CPB) and cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* Completed cardiac surgery with Cardiopulmonary Bypass and subsequently placed on venoarterial (VA) Extracorporeal Membrane Oxygenation (ECMO) support at any point during the ongoing hospitalization
* Serum Antithrombin \< 60%.

Exclusion Criteria:

* Heart transplantation during ongoing hospitalization
* Excessive bleeding (300 ml/hr of chest tube drainage for 2 consecutive hours)
* Weight \< 40 kg
* Allergy to goat products
* Anticoagulation with a direct thrombin inhibitor
* Religious exception to blood products
* Hypothermia (\< 34°C)

Primary outcomes:
measure: Percentage of time within the serum AT level target range of 80-100%
timeFrame: 72 hour infusion period
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: William C. Oliver, Jr., MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02288793: Focused Assessment With Sonography in Trauma
Official title: Prepared for Focused Assessment With Sonography in Trauma Examination?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Trauma
Ultrasonography
Keywords: attitudes
knowledge
examination
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-11-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical staff: medical doctors, nurses, paramedics Medical students: PhD students, medicine students, nursing and paramedics studies

Brief summary: The study evaluates the knowledge and attitude about Focused Assessment with Sonography in Trauma examination among medical students and medical staff in Poland.


Eligibility criteria: Inclusion Criteria:

* Give voluntary consent to participate in the study

Exclusion Criteria:

* not meet the above criteria

Primary outcomes:
measure: Results of the Medical Knowledge Tool (Questionnaire)
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovia
Study officials:
References: