louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02563249: Influence of Gravity on Dexterity, Hand-eye Coordination and Perception of Orientation and Distances
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2015-09-30
Enrollment: 90
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: BASIC_SCIENCE

Brief summary: If investigators know that the anticipatory mechanisms involved in precision grip take into account the gravity, however it is unclear how they adapt to changes in the gravitational level. The objectives of this study are to study and model the movement control and the mechanisms underlying learning and adapting to the condition of weightlessness. Specifically, i) investigators will determine if a change in the level of gravity is taken into account when controlling grip force and ii) investigators will examine the effects of gravity change on hand-eye coordination.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers, male or female
* 18 to 65 years
* Affiliated with a Social Security plan or holder of a European Health Insurance Card (EHIC - European Health Insurance Card - EHIC).
* Having an aeronautical medical certificate of fitness for flight personnel unprofessional functions in civil aviation.
* Agreeing to participate in the study
* Having given informed consent

Exclusion Criteria:

* person not affiliated to a Social Security Inssurance,
* person who participated in a clinical trial within the trial below the exclusion period,
* person with a medical history or any acute or chronic condition that can affect the test results, or by running a risk on during the protocol, especially topics: past or present history of neurological disease, rheumatologic or otologic (hearing or equilibration) OR person with a corrected visual acuity of less than 5 / 10th.
* pregnant women.

Primary outcomes:
measure: Gravity induced changes in grip strength (newton) exerted between the fingers measured with strain gauges
timeFrame: baseline
measure: Gravity induced changes in oculo-manual coordination measured by the latency (ms) of anticipatory eye movement measurement with videooculography
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Caen CEDEX
country: France
facility: Umr Ucbn/Inserm U1075 Comete
state: Basse-Normandie
Study officials:
References:
Clinical trial NCT06575049: Seroma and Hematoma Rates: MAXIGESIC IV vs. Ketorolac in Breast Cancer Surgery
Official title: Comparative Analysis of Seroma and Hematoma Rates: MAXIGESIC vs. Ketorolac in Breast Cancer Surgery Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Breast Cancer
Post-Operative Hematoma
Seroma as Procedural Complication
Post-Op Complication
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Among patients who underwent breast cancer surgery at Seoul National University Hospital from January 1, 2023 to December 31, 2023, 127 patients were prescribed ketorolac and wore compression dressings. The number of patients was calculated to be approximately 60 to collect basic data to confirm the feasibility of conducting the main study.

Brief summary: The investigators aim to compare the incidence rates of seroma (fluid collection) and hematoma (blood clot) following breast cancer surgery between the conventional non-steroidal anti-inflammatory drug (NSAID) Ketorolac and MAXIGESIC. The investigators seek to determine the complication rates in patients receiving MAXIGESIC post-surgery, hypothesizing that the higher dosage of ibuprofen in MAXIGESIC compared to Ketorolac will result in lower complication rates.


Eligibility criteria: Inclusion Criteria:

* Systemic performance status 0-2 according to ECOG criteria
* Patients with adequate renal function: serum Cr 1.4 mg/dL or less
* Patients with adequate liver function Bilirubin, AST/ALT: 1.5 times or less of the upper limit of normal, Alkaline phosphatase: 1.8 times or less of the upper limit of normal
* Patients undergoing total mastectomy with SLNB or ALND (mastectomy and axillary sentinel lymph node dissection)
* Patients undergoing breast-conserving surgery with ALND (mastectomy and axillary dissection)
* Patients who voluntarily decided to participate in this study and signed a written informed consent form

Exclusion Criteria:

* Patients undergoing immediate reconstruction operation
* Patients with drug allergies to painkillers and anti-inflammatory drugs
* Patients with a physical condition that would interfere with understanding and submitting the consent form

Primary outcomes:
measure: Postoperative hemovac or JP total drainage amount
timeFrame: within 3 months
measure: hematoma incidence
timeFrame: within 3 months
measure: Seroma incidence
timeFrame: within 3 months
Secondary outcomes:
measure: Length of hospital stay
timeFrame: within 3 months
measure: Complication
timeFrame: within 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03937349: Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients
Official title: Impact of Parathyroidectomy on Cardiovascular Calcification in Dialysis-dependent Patients: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Secondary Hyperparathyroidism
Chronic Kidney Disease Mineral and Bone Disorder
Vascular Calcification
Dialysis
Lead sponsor: Saint Petersburg State University, Russia
Sponsor class: OTHER
First posted: 2019-05-03
Enrollment: 63
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: Patients receiving long-term dialysis treatment, met the criteria for parathyroidectomy due to severe SHPT

Brief summary: This is a prospective cohort study aimed to evaluate change of cardiovascular calcification after parathyroidectomy in patients with end-stage renal disease on dialysis compared with control group on conservative treatment.


Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years
2. ESRD patients receiving long-term hemodialysis or peritoneal dialysis treatment
3. Severe secondary hyperparathyroidism defined as iPTH level \> 800 pg/ml, followed with hypercalcemia and/or hyperphosphatemia; with presence of one or more nodular or diffuse parathyroid hyperplasia confirmed with CT

Exclusion Criteria:

1. Primary hyperparathyroidosis as a cause of ESRD

Primary outcomes:
measure: Change in coronary artery calcium score measured with CT
timeFrame: 18 months
measure: Change in vascular calcification score measured with semi-quantitative (Kauppila) test
timeFrame: 18 months
Secondary outcomes:
measure: Change in heart valve calcium score
timeFrame: 18 months
measure: Change in intact parathyroid hormone (iPTH) level
timeFrame: 18 months
measure: Change in serum calcium level
timeFrame: 18 months
measure: Change in serum phosphate level
timeFrame: 18weeks
measure: Change in alkaline phosphatase
timeFrame: 18 months
measure: Serious adverse events (cardiovascular events, death, fractures, emergency hospital admissions) during the follow-up period
timeFrame: 18 months
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: Saint-Petersburg State University, Clinic of advanced medical technologies n.a. N.I.Pirogov
Study officials:
affiliation: Saint Petersburg State University, Russia
name: Ekaterina Parshina, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03267849: Lamina Cribrosa Depth Change With Change in Eye Pressure
Official title: Lamina Cribrosa Depth Change With Change in Eye Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma, Open-Angle
Keywords: biomarker
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Topcon Corporation
First posted: 2017-08-30
Enrollment: 309
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a study of the compliance of the lamina cribrosa with change in eye pressure.

Detailed description: Glaucoma patients and control subjects will have their internal eye structure (lamina cribrosa) imaged by optical coherence tomography (OCT) standard images at two different eye pressures. In some participants, the eye pressure will be changed by one of two interventions, wearing goggles or having laser suturelysis

Eligibility criteria: Inclusion Criteria:

* persons who consent to drink water and be imaged

Exclusion Criteria:

* non-consenting persons
* those who cannot be imaged

Primary outcomes:
measure: Change in anterior lamina cribrosa depth
timeFrame: Up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Professor
name: Harry A Quigley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Czerpak CA, Kashaf MS, Zimmerman BK, Quigley HA, Nguyen TD. The Strain Response to Intraocular Pressure Decrease in the Lamina Cribrosa of Patients with Glaucoma. Ophthalmol Glaucoma. 2023 Jan-Feb;6(1):11-22. doi: 10.1016/j.ogla.2022.07.005. Epub 2022 Jul 19.
Clinical trial NCT02162706: Salivary Cortisol Measurements by Mass Spectrometry
Official title: Pilot Study of Salivary Cortisol Measurements by Mass Spectrometry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endocrine Disorders
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2014-06-13
Enrollment: 50
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with possible endocrine disorders seen during outpatient pediatric endocrinology visit or inpatient consultations. Healthy controls were open to the general public in California.

Brief summary: Cortisol is a hormone critical for survival in times of stress. Currently most measurements are done with blood samples. The hypothesis of this study is cortisol measured from saliva using mass spectrometry can be used to replace measurements by blood.

Detailed description: Cortisol levels change depending on the time of day. Salivary samples were collected from health controls at bedtime, midnight and first morning waking on two consecutive nights and salivary cortisol levels were measured using mass spectrometry. In a patients with possible endocrine disorders who were going through an adrenocortiotropin stimulation test for adrenal insufficiency, salivary cortisol was measured prior to giving cosyntropin and 30-40 minutes after cosyntropin.

Eligibility criteria: Inclusion Criteria:

* Normal subjects
* Subjects with possible endocrine disorder

Exclusion Criteria:

* Tracheostomy or ventilator dependent
* Gastrotomy tubed dependent or unable to eat/drink by mouth

Primary outcomes:
measure: Salivary Cortisol
timeFrame: All collections are done within 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Lucile Packard Children's Hospital and Stanford Clinics
state: California
Study officials:
affiliation: Stanford University
name: Tandy Aye, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Deutschbein T, Unger N, Mann K, Petersenn S. Diagnosis of secondary adrenal insufficiency: unstimulated early morning cortisol in saliva and serum in comparison with the insulin tolerance test. Horm Metab Res. 2009 Nov;41(11):834-9. doi: 10.1055/s-0029-1225630. Epub 2009 Jul 7.
citation: Baid SK, Sinaii N, Wade M, Rubino D, Nieman LK. Radioimmunoassay and tandem mass spectrometry measurement of bedtime salivary cortisol levels: a comparison of assays to establish hypercortisolism. J Clin Endocrinol Metab. 2007 Aug;92(8):3102-7. doi: 10.1210/jc.2006-2861. Epub 2007 Jun 5.
citation: Chao CS, Shi RZ, Kumar RB, Aye T. Salivary cortisol levels by tandem mass spectrometry during high dose ACTH stimulation test for adrenal insufficiency in children. Endocrine. 2020 Jan;67(1):190-197. doi: 10.1007/s12020-019-02084-8. Epub 2019 Sep 18.
Clinical trial NCT04485806: Culture Media Microdroplet Geometry With Different Oil Overlay and Its Effect on Embryonic Development.
Official title: The Effect of Culture Media Microdroplet Geometry and Different Oil Overlay on Pre Implantation Embryonic Development in Dry Incubators: Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Embryonic Development
Infertility
Keywords: dry incubator
Osmolality
Oil overlay
Microdrops
Lead sponsor: Ganin Fertility Center
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Effect of two different culture dishes with two different oil overlay which used in human embryos culturing through ICSI procedures on the pre implantaion embryonic development.
Primary purpose: OTHER

Brief summary: A prospective randomized study included 1695 MII sibling oocytes collected from 100 patients undergoing ICSI.

Detailed description: Purpose:

to determine the effect of culture media microdroplet geometry of different culture dishes and oil overlay on the pre implantation embryo development in dry incubators

Method:

We used sibling oocytes splits between two different dishes : GPS (life global, USA) and SPL (life science, Korea) with two different oils : light mineral oil (LM)(Irvine, USA) and paraffin oil (PO)(Vitro life, Sweden). All embryos cultured in dry incubators at the same conditions.

statistical analysis done using SPSS version 23

Eligibility criteria: Inclusion Criteria:

* Female age is ≤ 37 years old with ≥ 8 MII oocytes
* Males with normal semen parameters (WHO 2010).
* We conducted three experiments all with Siblings oocytes splits and all embryos

Exclusion Criteria:

* Oocyte or sperm donation.
* Sever male factor.
* Any contradictions to undergoing in vitro fertilization or goandotropin stimulation.

Primary outcomes:
measure: Blastulation rate
timeFrame: 5-6 days after ICSI
measure: High quality blast rate
timeFrame: 5-6 days after ICSI
Secondary outcomes:
measure: Fertilization rate
timeFrame: 16-19 hours of ICSI
measure: Cleavage rate
timeFrame: 72 hours of ICSI
measure: High quality D3 embryos
timeFrame: 72 hours of ICSI
measure: Good quality trophectoderm/inner cell mass
timeFrame: 5-6 days after ICSI
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ganin Fertility Center
Study officials:
affiliation: Ganin Fertility Center
name: Manar M Hozyen, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Amr Elshimy, BSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Hanaa Elkhader, BSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ganin Fertility Center
name: Hosam Zaki, MSc.
role: STUDY_CHAIR
References:
Clinical trial NCT03080506: Abdominal Binder Following Cesarean Delivery
Official title: Effect of Elastic Abdominal Binder on Pain and Functional Recovery After Cesarean Delivery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section Complications
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2017-03-15
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cesarean delivery is a common obstetrical procedure and is associated with increased maternal morbidity and mortality. Pain and limited mobilization are major contributing factors that result in delayed functional recovery and complications. Elastic abdominal binder, a wide elastic belt that is wore around the patient's abdomen to support surgical incision after surgery, has been employed by clinicians for pain relief, wound complications prevention, improved pulmonary function, and stabilization. Benefits of the abdominal binder use have not been properly examined.

The aim of this study is to examine the effect of postcesarean elastic abdominal binder use on recovery by comparing pain scores and mobility function (through the 6-minute walk test \[6MWT\]) in postcesarean mothers who use versus do not use the elastic abdominal binder to support incisional site.


Eligibility criteria: Inclusion Criteria:

* Pregnant women undergoing cesarean delivery

Exclusion Criteria:

* Cesarean hysterectomy
* Intraoperative accidental injury to urinary or gastrointestinal organs
* Postoperative admission to intensive care unit (ICU)
* Postoperative intraperitoneal drain placement
* Unable to understand and follow oral/written instructions
* Severe neuromuscular or circulatory disorders
* Pulmonary diseases

Primary outcomes:
measure: Daily average postoperative pain scores
timeFrame: An average of pain scores at 8:00 am and 4:00 pm, up to 7 days postoperation
measure: Postoperative functional recovery
timeFrame: In the morning of postoperative day 3
Secondary outcomes:
measure: Quality of life
timeFrame: In the morning of postoperative day 3
measure: Postoperative complications
timeFrame: In the morning, up to 7 days postoperation
Other outcomes:
Locations:
city: Chiang Mai
country: Thailand
facility: Department of OB-GYN, Faculty of Medicine, Chiang Mai University
Study officials:
affiliation: Chiang Mai University
name: Kittipat Charoenkwan, MD, MSc
role: STUDY_CHAIR
References:
citation: Zimpel SA, Torloni MR, Porfirio GJ, Flumignan RL, da Silva EM. Complementary and alternative therapies for post-caesarean pain. Cochrane Database Syst Rev. 2020 Sep 1;9(9):CD011216. doi: 10.1002/14651858.CD011216.pub2.
Clinical trial NCT03205306: Myasthenia Gravis and Psyche
Official title: Myasthenia Gravis and Psyche
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myasthenia Gravis
Keywords: Myasthenia Gravis
Psyche
Depression
Anxiety Disorder
Posttraumatic Stress Disorder
Disease Processing
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: NeuroCure Clinical Research Center, Charite, Berlin
First posted: 2017-07-02
Enrollment: 1399
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Myasthenia Gravis and their relatives

Brief summary: The purpose of the study is to systematically capture and characterize mental comorbidities for patients with myasthenia gravis. Anxiety disorders and depression for example, can negatively affect the quality of life and lead to e.g. unemployment and early retirement especially in young patients.

Additionally the researchers want to find out in what way certain aspects of the disease have an influence on the quality of life, and whether different concepts of coping with the disease have different effects on the quality of life for patients with myasthenia gravis.

During the study, close relatives of patients will also be asked to provide input about their current stress situation in the context of supporting their relative.

Based on the results, the investigators want to improve and supplement established treatment concepts, to ensure a more comprehensive and individual treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with Myasthenia Gravis
* Age ≥18 years

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Questionnaire Survey (Patient)
timeFrame: directly after inclusion in the study
Secondary outcomes:
measure: "Häusliche Pflegeskala" (HPS)
timeFrame: directly after inclusion in the study
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: NeuroCure Clinical Research Center (NCRC), Charité
Study officials:
affiliation: Charite University, Berlin, Germany
name: Andreas Meisel, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Marbin D, Piper SK, Lehnerer S, Harms U, Meisel A. Mental health in myasthenia gravis patients and its impact on caregiver burden. Sci Rep. 2022 Nov 11;12(1):19275. doi: 10.1038/s41598-022-22078-3.
Clinical trial NCT02920606: Pulpotomy as a Treatment of Irreversible Pulpitis
Official title: Pulpotomy as a Permanent Treatment of Irreversible Pulpitis on Mature Molar Teeth - a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Irreversible Pulpitis
Keywords: pulpotomy
pulpitis
mature tooth
tricalcium silicate
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2016-09-30
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The procedure currently recommended for the treatment of irreversible pulpitis is the endodontic treatment, i.e. the complete elimination of the pulp, disinfection and obturation of the whole root canal system. The emergency procedure consists of a pulpotomy, followed at an ulterior appointment by the root canal treatment. The purpose of the present pilot study is to evaluate the feasibility of performing the pulpotomy as a permanent treatment in mature molars. If hemostasis can be achieved after removing the coronal part of the pulp, a tricalcium silicate cement will be directly applied on the remaining pulp at the root canal entrances. A short-term follow-up will be performed at one week by evaluating the pain relief of the patient. Long-term success will then be evaluated every year by verifying the absence of periapical radiolucency on the x-ray as well as the absence of clinical symptoms and signs. A standard root canal procedure will serve as control. During the pulpotomy treatment, blood sample with microcapillary will be performed. We will analyze a ratio of pro-inflammatory and anti-inflammatory cytokines.


Eligibility criteria: Inclusion Criteria:

* Good general health
* Not pregnant women
* At least one permanent molar in irreversible pulpitis
* Adult patient
* Mentally competent

Exclusion Criteria:

* Periapical radiolucency
* Periodontical probing
* Root fracture
* Sinus tract
* Swelling or mobility
* External or/and internal resorption
* Open apicies
* A non restorable tooth

Primary outcomes:
measure: Evaluation of the success rate (%) at 1 year
timeFrame: Follow up at 1 year for all patients included in the study
Secondary outcomes:
measure: Evaluation of the correlation between pro/anti-inflammatory cytokines and the success of pulpotomy
timeFrame: Follow up at 1 year for all patients included in the study
Other outcomes:
measure: Evaluation of the success rate (%) up to 4 years
timeFrame: Follow up at 4 years for all patients included in the test group
Locations:
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Julian G Leprince, Professor
role: STUDY_CHAIR
References: