louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02584166: Intervention of Psychological and Ethical Professionals of Human Science in Obstetrical Morbidity and Mortality Conferences (OPERA)
Official title: Intervention of Psychological and Ethical Professionals of Human Science in Obstetrical Morbidity and Mortality Conferences
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Newborns
Keywords: Morbidity
Mortality
conferences
human science
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-10-22
Enrollment: 4929
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All newborns born between 1er october 2008 and 30 November 2010 (in one of the 95 maternity units which belongs to one of the 5 perinatal networks).

Brief summary: This cluster-randomised controlled trial will test the hypothesis that a multifaceted program with psychological intervention in morbidity mortality conferences (MMC) improve care quality and reduce the rate of morbidity mortality perinatal in diverse obstetric care settings.


Eligibility criteria: Inclusion Criteria:

* all newborns born between 1er october 2008 and 30 November 2010 (minimum : 22 weeks of gestation)

Exclusion Criteria:

* newborns died in context of abortion

Primary outcomes:
measure: the rate of non conform management of morbidity and mortality cases
timeFrame: at 26th month
Secondary outcomes:
measure: the rate of avoidable mortality and morbidity cases
timeFrame: at 26th month
measure: the incidence of mortality and morbidity among number of births
timeFrame: at 26th month
Other outcomes:
Locations:
Study officials:
References:
citation: Dupont C, Winer N, Rabilloud M, Touzet S, Branger B, Lansac J, Gaucher L, Duclos A, Huissoud C, Boutitie F, Rudigoz RC, Colin C; OPERA group. Multifaceted intervention to improve obstetric practices: The OPERA cluster-randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2017 Aug;215:206-212. doi: 10.1016/j.ejogrb.2017.06.026. Epub 2017 Jun 19.
Clinical trial NCT01889966: VasoREACTivity Testing With Intravenous SILdenafil in Patients With Precapillary Pulmonary Hypertension
Official title: Vasoreactivity Testing With Intravenous Sildenafil in Patients With Precapillary Pulmonary Hypertension (Treatment Optimisation Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Hypertension Associated With Connective Tissue Disease
Keywords: vasoreactivity testing
Sildenafil
precapillary pulmonary hypertension
connective tissue disease
mean pressure in the pulmonary artery 25 mmHg or more
mean pulmonary capillary wedge pressure below 16 mmHg
Lead sponsor: Kerckhoff Heart Center
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2013-07-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Sildenafil is a selective pulmonary vasodilator; in patients with a special kind of pulmonary hypertension it is approved for treatment. The trial seeks to find out, whether the acute response to this treatment (= vasoreactivity testing) given intravenously is effective and allows prediction of therapy success during a following oral treatment.


Eligibility criteria: Inclusion Criteria:

* Precapillary pulmonary hypertension associated with connective tissue disease
* resting mean pressure in the pulmonary artery of \> 24 mmHg
* resting mean pulmonary capillary wedge pressure (PCWP) of \< 16 mmHg
* age 18 to 80 years
* women of childbearing potential must have a negative pregnancy test (ß-HCG in urine) and must use effective methods of contraception
* women must not be breastfeeding
* ability to understand and sign the informed consent, correctly signed informed consent

Exclusion Criteria:

* pretreatment with Sildenafil
* contraindications for Sildenafil treatment:

  * known intolerance to Sildenafil,
  * optic neuropathy (NAION),
  * known hereditary retina disease,
  * need of nitrate therapy
* advanced liver cirrhosis - CHILD C
* severely reduced renal function with GFR \< 30 ml/min/1,73 m²
* stroke or myocardial infarction within the last 6 months

Primary outcomes:
measure: efficacy of Sildenafil I.V. for vasoreactivity testing
timeFrame: 1.5 hours
Secondary outcomes:
measure: clinical efficacy of sildenafil per os predicted by testing it intravenously in the course of oral therapy
timeFrame: 90 days
Other outcomes:
Locations:
city: Bad Nauheim
country: Germany
facility: Kerckhoff Heart Center
Study officials:
affiliation: Kerckhoff Heart Center
name: Andreas J Rieth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rieth AJ, Richter MJ, Berkowitsch A, Frerix M, Tarner IH, Mitrovic V, Hamm CW. Intravenous sildenafil acutely improves hemodynamic response to exercise in patients with connective tissue disease. PLoS One. 2018 Sep 20;13(9):e0203947. doi: 10.1371/journal.pone.0203947. eCollection 2018.
Clinical trial NCT06278766: A Study to Assess the Mass Balance of [14C] ABBV-552 in Healthy Male Participants Following Single Oral Dose Administration
Official title: Mass Balance Study of [14C] ABBV-552 in Healthy Male Volunteers Following Single Oral Dose Administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Healthy Volunteer
ABBV-552
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-02-26
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate mass balance, pharmacokinetics and safety of \[14C\] ABBV-552 in healthy, male volunteers following administration of a single oral dose.


Eligibility criteria: Inclusion Criteria:

- Male volunteers in general good health at Screening.

Exclusion Criteria:

- Considering fathering a child or donating sperm during the study and for 100 days after study drug administration.

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to approximately 30 days
measure: Maximum observed concentration (Cmax) of ABBV-552
timeFrame: Up to approximately Day 15
measure: Time to Cmax (peak time, Tmax) of ABBV-552
timeFrame: Up to approximately 15 days
measure: Terminal phase elimination rate constant (λz) of ABBV-552
timeFrame: Up to approximately 15 days
measure: Terminal phase elimination half-life (t1/2) of ABBV-552
timeFrame: Up to approximately 15 days
measure: Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration (AUCt) of ABBV-552
timeFrame: Up to approximately 15 days
measure: Area under the plasma concentration-time curve (AUC) from time 0 to infinite time (AUCinf) of ABBV-552
timeFrame: Up to approximately 15 days
measure: Amount of ABBV-552 excreted in the urine over the sampling period (Aeu)
timeFrame: Up to approximately 15 days
measure: Percent of ABBV-552 excreted in the urine
timeFrame: Up to approximately 15 days
measure: Renal clearance ABBV-552 (CLr)
timeFrame: Up to approximately 15 days
measure: Amount of ABBV-552 excreted in the feces over the sampling period (Aef)
timeFrame: Up to approximately 15 days
measure: Percent radioactivity excreted in the feces
timeFrame: Up to approximately 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: Fortrea Clinical Research Unit Inc /ID# 262684
state: Wisconsin
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06482866: Synechie Afrer Rhinosug. Proc. 2024
Official title: Risk Factors Leading to the Formation of Intranasal Synechiae in Patients After Endonasal Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication of Surgical Procedure
Lead sponsor: Multidisciplinary Regional Hospital in Gorzow
Sponsor class: OTHER
First posted: 2024-07-01
Enrollment: 243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who were operated in Polish hospital (Gorzów Wlkp).

Brief summary: Analyze the factors influencing the development of intranasal adhesions (synechiae), with particular emphasis on the use of nasal septal separators, and to suggest a solution to reduce this complication in the future.

Analyze of the medical documentation. It was not an experimental examination.


Eligibility criteria: Inclusion Criteria:

* septo or septoconchoplasty

Exclusion Criteria:

* incompleted documentation

Primary outcomes:
measure: Synechie
timeFrame: Between 2 weeks to 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Gorzów Wielkopolski
country: Poland
facility: Multidisciplinary Regional Hospital
state: Woj. Lubuskie
Study officials:
References:
Clinical trial NCT04313166: Treatment Continuation Study for Patients With ALS/MND Who Completed Study CMD-2019-001
Official title: A Treatment Continuation Study for Patients With Amyotrophic Lateral Sclerosis/Motor Neuron Disease Who Have Successfully Complete Study CMD-2019-001
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: Collaborative Medicinal Development Pty Limited
Sponsor class: INDUSTRY
First posted: 2020-03-18
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Provides up to six months treatment with CuATSM for subjects who have successfully completed study CMD-2019-001

Detailed description: Provides up to six months treatment with CuATSM for subjects who have successffulyl completed study CMD-2019-001. \[This allows subjects randomized to placebo on study CMD-2019-001 to receive up to six months treatment with CuATSM and provides an up to an additional six months treatment with CuATSM for subjects randomized to CuATSM on study CMD-2019-001\]

Eligibility criteria: Inclusion Criteria:

* signed informed consent prior to initiation of any study-specific procedures and treatment
* documented completion of protocol-specified assessments following completion of 24 weeks treatment on study CMD-2019-002
* Investigator considers patient has been tolerating treatment on study CMD-2019-001 and may benefit from continued treatment with CuATSM

Exclusion Criteria:

* not dependent on mechanical ventilation

Primary outcomes:
measure: Treatment-related changes in disease severity
timeFrame: 24 weeks
Secondary outcomes:
measure: Treatment-related changes in cognitive function
timeFrame: 24 weeks
measure: Treatment-related changed in respiratory function
timeFrame: SVC
measure: Treatment tolerance
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Macquarie Park
country: Australia
facility: Macquarie University
state: New South Wales
Study officials:
affiliation: Macquarie University
name: Dominic Rowe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06733766: Ultrasound-guided Thermal Ablation for Recurrent Thyroid Cancer
Official title: Ultrasound-guided Thermal Ablation for Recurrent Thyroid Cancer: A Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Recurrent Thyroid Cancer
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-12-13
Enrollment: 300
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 recurrent thyroid cancer

Brief summary: To evaluate the long-term outcomes of ultrasound-guided thermal ablation for recurrent thyroid cancer

Detailed description: To evaluate and predict the long-term outcomes of ultrasound-guided thermal ablation for recurrent thyroid cancer by a multicenter study

Eligibility criteria: Inclusion Criteria:

1. patient received thyroidectomy for thyroid cancer
2. recurrent lesions were pathologically proven to be malignant by core-needle biopsy or fine needle aspiration
3. no evidence of distant metastases.
4. follow-up period ≥12 months

Exclusion Criteria:

1. coagulation disorder, serious heart, respiratory, liver, or renal failure
2. dysfunction of the vocal cord on the opposite side

Primary outcomes:
measure: rate of disease progression
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: rate of complications
timeFrame: 1 week
measure: rate of volume reduction
timeFrame: through study completion, an average of 6 months
measure: rate of tumor disappearance
timeFrame: through study completion, an average of 6 months
measure: Tg level
timeFrame: through study completion, an average of 6 months
measure: rate of delayed surgery
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Yukun Luo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03110666: Treatment for Knee Osteoarthritis With Injections of BMC at the Bone-cartilage Interface. Pilot Study
Official title: Treatment for Knee Osteoarthritis With Injections of Autologous Concentrated Bone Marrow Aspirate at the Bone-cartilage Interface Via Percutaneous. Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis ,
bone marrow aspirate
injections
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2017-04-12
Enrollment: 17
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: autologous concentrated bone marrow aspirate
Primary purpose: TREATMENT

Brief summary: This pilot study will evaluate the clinica! and radiological results of a treatment for knee osteoarthritis with injections of autologous concentrated bone marrow aspirate at the bone-cartilage interface via percutaneous.

Detailed description: This pilot study (N=30) patients will evaluate the clinica! and radiological results of a treatment for knee osteoarthritis with injections of bone marrow concentrate (BMC),obtained from the Bone Marrow Aspirate Concentration System (BioCUE) at the bone-cartilage interface via percutaneous injections. The PerFuse system will also be evaluated to determine if it can be used to deliver the BMC to the osseous sites. Follow-up is 1, 3, 6, 12, and 24 months.

Eligibility criteria: Inclusion Criteria:

* age ranging from 40 to 75
* Osteoarthritis of the medial or lateral compartment (2-3-4 grade according to the Kellgren-Lawrence score);
* Failure after at least 6 months of conservative treatment (drug therapy with NSAIDs,hyaluronic acid,platelet-rich plasma and corticosteroids injections);
* Signature of informed consent.

Exclusion Criteria:

* Patients with trauma in the 6 months prior to the intervention;
* Patients with malignancies;
* Patients with rheumatic diseases;
* Patients with diabetes;
* Patients suffering from metabolic disorders of the thyroid;
* Patients being abuse of alcohol, drugs or medications;
* Body Mass Index\> 35;

Primary outcomes:
measure: improvement of the International Knee Documentation Committee (IKDC) subjective score
timeFrame: Time Frame: 1,3,6, 12, 24 months evaluation
Secondary outcomes:
measure: improvement of the Knee Injury and osteoarthritis Outcome Score (KOOS)
timeFrame: Time Frame: 1,3,6, 12, 24 months evaluation
measure: evaluation of WORMS score for MRI
timeFrame: Time Frame: 6, 12, 24 months evaluation
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Rizzoli Orthopaedic Institute
Study officials:
affiliation: Rizzoli Orthopedic Institute
name: Elizaveta Kon, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03778866: Comparing HEPES-buffered With Bicarbonate-buffered as Handling Media During the ICSI Procedure on Live Birth Rate
Official title: Whether the Use of HEPES-buffered Medium Would Affect Live Birth Rate After ICSI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Ibn Sina Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Banoon IVF Center
name: Quena IVF Center
First posted: 2018-12-19
Enrollment: 1057
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The pH stability during human gamete handling for intracytoplasmic sperm injection (ICSI) is physiologically sound. As the pH change for bicarbonate-buffered medium, scientists assumed whether the use of HEPES or MOPS buffered medium would provide more stable pH, thereby better outcomes. However, the oil use and time frame outside the incubators have not been accounted for. This study is to evaluate the use of HEPES buffered medium compared with the bicarbonate-buffered medium on ICSI outcomes.


Eligibility criteria: Inclusion Criteria:

* ICSI indicated cycles

Exclusion Criteria:

* severe medical illness

Primary outcomes:
measure: live birth rate
timeFrame: 40 weeks
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: 12 weeks
measure: biochemical pregnancy rate
timeFrame: two weeks
measure: embryo developmental rates
timeFrame: 6 days of culture
measure: Ongoing pregnancy rate
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Banon Assiut
city: Qena
country: Egypt
facility: Qena Fertility Center
city: Sohag
country: Egypt
facility: IbnSina IVF Center
Study officials:
References:
Clinical trial NCT00285766: Safety, Tolerability and Efficacy of the Transdermal System in Elderly Subjects With Major Depression
Official title: A Phase III, Open-Label Study of the Safety, Tolerability and Efficacy of the Selegiline Transdermal System in Elderly Subjects With Major Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depression
Keywords: Depression
Lead sponsor: Somerset Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2006-02-02
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objective of this 16-week, open-label study is to assess the safety and tolerability of once daily application of three doses of STS during continuous dosing in the treatment of elderly subjects with major depression. Subjects will have study visits (clinic visits) at beginning of study (baseline) and study weeks 1, 3, 5, 8, 12, and 16.


Eligibility criteria: * Men/Women in good health 65 years or older
* Ability to read, understand and sign study informed consent
* Major depression- mild to severe based on rating scale

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Mohammed Bari, M.D.
state: California
city: San Diego
country: United States
facility: Charles Meredith, M.D.
state: California
city: Upland
country: United States
facility: Daniel Zimbroff, M.D.
state: California
city: Walnut Creek
country: United States
facility: Kathleen Toups, M.D.
state: California
city: Boynton Beach
country: United States
facility: Abbey Strauss, M.D.
state: Florida
city: Miami Beach
country: United States
facility: Barry Baumel, M.D.
state: Florida
city: St. Petersburg
country: United States
facility: Margarita Nunez, M.D.
state: Florida
city: St. Petersburg
country: United States
facility: Mildred Farmer, M.D.
state: Florida
city: Tamarack
country: United States
facility: Larry Eisner, M.D.
state: Florida
city: Winter Park
country: United States
facility: Andrew Cutler, M.D.
state: Florida
city: Atlanta
country: United States
facility: Robert Riesenberg, M.D.
state: Georgia
city: Florence
country: United States
facility: James Hartford, M.D.
state: Kentucky
city: Baltimore
country: United States
facility: Mitchel Kling, M.D.
state: Maryland
city: Oklahoma City
country: United States
facility: Louise Beckett, M.D.
state: Oklahoma
city: Wichita Falls
country: United States
facility: Penny Barnhart, M.D.
state: Texas
Study officials:
References:
Clinical trial NCT06736366: Study With Two Coenzyme Q10 Products
Official title: Comparative Single-dose Bioavailability Clinical Study of Two Different Coenzyme Q10 Products
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coenzyme Q Deficiency
Keywords: single dose bioavailability
Coenzyme Q10
Lead sponsor: University of Primorska
Sponsor class: OTHER
Collaborators: name: Biostile d.o.o.
name: QFarm s.r.l.
First posted: 2024-12-16
Enrollment: 35
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief summary: The randomized, open-label, two period crossover single-dose bioavailability study with two coenzyme Q10 products

Detailed description: The randomized, open-label, two period crossover single-dose bioavailability study with two coenzyme Q10 products will include 35 subjects who will test two different coenzyme Q10 products. Plasma concentration of coenzyme Q10 will be measured.

Eligibility criteria: Inclusion Criteria:

* subject informed consent form
* aged between 50 and 65 years old
* body mass for women 70± 5 kg and for men 85± 5 kg
* non-smoking
* healthy, without cardio-vascular diseases, diabetes, neurodegenerative diseases
* absence of any prescribed medication during the study
* willing to avoid a consumption of any food supplements at least 2 weeks before and during the study

Exclusion Criteria:

* cardio-vascular diseases, diabetes, neurodegenerative diseases, gastrointestinal disorders, pregnancy, breast-feeding
* intake of any food supplements within two week of the beginning of the study
* drug or alcohol abuse

Primary outcomes:
measure: Plasma levels of Coenzyme Q10
timeFrame: At Baseline
measure: Plasma levels of Coenzyme Q10
timeFrame: Four hours after consumption
measure: Plasma levels of Coenzyme Q10
timeFrame: Six hours after consumption
measure: Plasma levels of Coenzyme Q10
timeFrame: Twelve hours after consumption
measure: Plasma levels of Coenzyme Q10
timeFrame: Twenty-four hours after consumption
measure: Plasma levels of Coenzyme Q10
timeFrame: Forthy-eight hours after consumption
Secondary outcomes:
Other outcomes:
Locations:
city: Izola
country: Slovenia
facility: University of Primorska, Faculty of Health Sciences
Study officials:
affiliation: University of Primorska, Faculty of Health Sciences
name: Ana Petelin, phD
role: PRINCIPAL_INVESTIGATOR
References: