louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06062667: The Effect of Fathers' Birth Experience on Paternal Attachment and Parenting Perception: Randomized Controlled Trial
Official title: Effect Of Fathers' Bırth Experıence On Paternal Attachment And Parentıng Perceptıon: A Randomızed Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Birth, First
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 100
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In recent years, fathers have become increasingly involved in research, but research on fathers still lags behind research on mothers. During the transition to parenthood, a complex network of relationships emerges between father, mother and baby. During the process of becoming parents, mothers and fathers begin to bond with their unborn children. The prenatal period is hypothesized to be predictive of later postnatal attachment and perception of parenting. Paternal involvement at birth is associated with positive child health outcomes and parental well-being.


Eligibility criteria: Inclusion Criteria:

* Spouses of primiparous pregnant women who had spontaneous pregnancies and were admitted to the delivery room for normal labor were included in the study.

Exclusion Criteria:

* women without husbands

Primary outcomes:
measure: The father-baby bonding of fathers who accompany their spouses in the delivery room is higher than fathers who do not accompany their spouses in the delivery room.
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Betül Uncu
Study officials:
References:
Clinical trial NCT01893567: Subject Reported Target-lesion Numeric Rating Scale Evaluation by Subjects With Plaque Psoriasis Treated With Clobex® (Clobetasol Propionate) Spray 0.05%
Official title: Subject Reported Target-lesion Numeric Rating Scale Evaluation by Subjects With Plaque Psoriasis Treated With Clobex® (Clobetasol Propionate) Spray 0.05%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Plaque Psoriasis
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2013-07-09
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the utility of a technological based rating scale for assessing improvement in plaque psoriasis with Clobex spray treatment.


Eligibility criteria: Inclusion Criteria:

* Subjects 18 years of age or older.
* Subjects with a board certified dermatologist clinical diagnosis of active moderate to severe psoriasis lesions affecting up to 20% of the body surface area at the baseline visit, and in the opinion of the investigator, is otherwise a good candidate for treatment with clobetasol propionate 0.05% spray.
* Subjects with a target lesion of at least 1 cm x 1 cm
* Subjects who agree to be photographed at each visit

Exclusion Criteria:

* Subjects with any condition or presentation that may, in the opinion of the investigator, may put the subject at risk, may confound study results, or may interfere with participation in the study.
* Subjects with any known allergies to any of the ingredients listed on the test article label or surgical ink.
* Subjects who are pregnant or breast-feeding, or who plan to become pregnant or breast feed during the course of the trial.
* Subjects that are relatives of the investigator, or are themselves or a relative of any study staff or any Galderma employee.
* Subjects who have participated in an investigational study within 30 days of enrollment; participated in biologic investigational studies within 90 days of enrollment, or subjects planning to participate in any other interventional clinical research study while enrolled in this trial.

Primary outcomes:
measure: Subject Reported Target Lesion Severity Score.
timeFrame: 2 weeks
Secondary outcomes:
measure: Investigator Reported Target Lesion Severity Score
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Fort Gratiot
country: United States
facility: Hamzavi Dermatology
state: Michigan
Study officials:
affiliation: Hamzavi Dermatology
name: Fasahat Hamzavi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01126567: Exploratory Biomarker Study of Cerebrospinal Fluid in Healthy Volunteers
Official title: A Study of the Effects of Sampling Rate on Cerebrospinal Fluid (CSF) Biomarker Levels in Healthy Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Phase 1 Clinical Trials, Cerebrospinal Fluid, Biomarker
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2010-05-19
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

Brief summary: The objective of this study is to determine the effects of cerebrospinal fluid sampling rate on biomarker levels of young, healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Age is between 18 and 50 years, inclusive
* Judged to be in general good health based on medical history, physical exam, neuro exam, vital signs, lab profile and ECG

Exclusion Criteria:

* Positive urine drug screen for drugs of abuse
* History of bleeding disorder or deep vein thrombosis
* History of migraine or other types of headache more than twice/month, history of spinal disc disease or chronic significant low back pain
* Use of blood thinning compounds within 10 days of lumbar drain placement
* Finding on head CT that contraindicates lumbar puncture
* History of spinal surgery
* Use of tobacco/nicotine containing products within 6 month period prior to initial lumbar drain placement

Primary outcomes:
measure: Multiple Exploratory Biomarkers
timeFrame: Day 1 (at 0, 1, 4, 8, 12, 18, and 24 hours)
measure: Multiple Exploratory Biomarkers
timeFrame: Day 1 (at 0, 1.2.3.4.5.6.7.8.9.10,12,14,16,18,20,22,and 24 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
state: California
Study officials:
affiliation: Abbott
name: Robert Lenz, M.D., Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02306967: Fluorescent Visualization in Early Oral Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Squamous Cell Carcinoma or Severe Dysplasia
Keywords: oral cancer
oral dysplasia
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Terry Fox Research Institute
First posted: 2014-12-03
Enrollment: 40
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: Studies from Vancouver show that fluorescent visualization (FV) is a useful method of controlling surgical margins. This early finding will now be confirmed in a national randomized controlled trial.


Eligibility criteria: Inclusion Criteria:

* biopsy proven invasive oral cancer or severe dysplasia / Cis
* invasive cancer must be T1 or T2
* no prior history of oral cancer / treatment of oral cancer

Exclusion Criteria:

* prior history of oral cancer
* unable to provide informed consent
* lesion not able to be completely visualized by FV

Primary outcomes:
measure: disease specific survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Hospital
state: Alberta
Study officials:
References:
Clinical trial NCT05112367: Epidemiology and Management of Pediatric Anaphylaxis and Allergy in the Pediatric Emergency Department of Montpellier
Official title: Retrospective Study on the Management of Pediatric Anaphylaxis and Clinical Signs of Allergy in the Pediatric Emergency Department of Montpellier University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anaphylaxis
Allergy
Keywords: Children
Emergency
Epinephrine
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 2500
Sex: ALL
Minimum age (years): 2
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children consulting in the paediatric emergency department of Montpellier for suspected allergy from 2016 to 2020

Brief summary: Anaphylaxis is a severe life-threatening reaction following exposure to an antigen. Its incidence is progressively increasing in the general population over years, especially among children. The diagnosis can be difficult, and recommendations for follow up and prescription for an emergency kit are rarely provided after emergency visit. The Investigators will evaluate the management of pediatric anaphylaxis and clinical signs of allergy in the pediatric emergency department of Montpellier University Hospital


Eligibility criteria: Inclusion criteria:

* Patients evaluated at the Montpellier University Hospital, Allergy Unit ;
* Children consulting for suspected allergy from 2016 to 2020

Exclusion criteria:

- Patients under legal protection, under guardianship or under curatorship;

Primary outcomes:
measure: Evaluation of the management of pediatric anaphylaxis of allergy
timeFrame: day 1
measure: Evaluation of the management of pediatric clinical signs evocative of allergy in the pediatric emergency department of Montpellier University Hospital.
timeFrame: day 1
Secondary outcomes:
measure: Evaluation of an appropriate use of epinephrine
timeFrame: day 1
measure: Evaluation of an appropriate use of a possible follow-up of patients after the episode
timeFrame: day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Davide CAIMMI
role: STUDY_DIRECTOR
References:
Clinical trial NCT00876967: Comparison of Three Laryngoscope Blades for Orotracheal Intubation in the Operating Room
Official title: Comparison of Performance of Three Laryngoscope Blades: Plastic Single Use, Metallic Single Use and Metallic Reusable Blades.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intubation
Keywords: anesthesiology
randomized
laryngoscope
intubation
laryngeal exposition
laryngoscope blades
plastic single use blade
metallic single use blade
metallic reusable blade
success to intubation at first attempt
Cormack and lehanne modify grade
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2009-04-07
Enrollment: 1040
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determinate if there is a difference in performance provided by three laryngoscope blades: plastic single use, metallic single use and metallic reusable blades.

Detailed description: Primary outcome: success of intubation at the first attempt

Secondary outcomes: quality of laryngeal exposition (Cormack and Lehanne modify grade), duration to success intubation, Intubation difficult Scale and result of intubation procedure

Eligibility criteria: Inclusion Criteria:

* patient age over 18 who need general anesthesia with orothracheal intubation

Exclusion Criteria:

* patient age under 18 or major assist
* presence of upper airway malformation or abnormality
* cervical or facial trauma
* previous difficult intubation known
* no use of curare
* Body Mass Index over 30kg/m2 if crush induction use

Primary outcomes:
measure: success of intubation at the first attempt
timeFrame: immediately
Secondary outcomes:
measure: quality of laryngeal exposition (Cormack and Lehanne modify grade)
timeFrame: immediately
measure: duration to success intubation
timeFrame: immediately
measure: Intubation difficult Scale
timeFrame: Immediately
measure: result of intubation procedure
timeFrame: immediately
Other outcomes:
Locations:
city: Caen
country: France
facility: University Hospital Caen
state: Basse-Normandie
Study officials:
affiliation: Anesthesiology critical care SAMU departement, University Hospital of Caen
name: HANOUZ Jean-Luc, PHD
role: STUDY_DIRECTOR
References:
citation: Buleon C, Parienti JJ, Lesage A, Grandin W, Pouliquen E, Flais F, Simonet T, Gerard JL, Hanouz JL. Comparison of plastic and metallic single-use and metallic reusable laryngoscope blades: a randomised controlled trial. Eur J Anaesthesiol. 2013 Apr;30(4):163-9. doi: 10.1097/EJA.0b013e32835c1cdb.
Clinical trial NCT00258167: Family Involvement in The Treatment Of a Mentally Ill Relative
Official title: Family Involvement in The Treatment Of a Mentally Ill Relative
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Families of Mentally Ill
Keywords: Family members
Illness burden
Mental Disorders
Family intervention
Lead sponsor: Lev-Hasharon Mental Healtlh Center
Sponsor class: OTHER_GOV
First posted: 2005-11-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: * Research demonstrates that the families of the seriously mentally ill are burdened by this caregiving role and by their responsibilities
* Research also demonstrates that family interventions are effective and that they have a potential to reduce family burden, as well as to improve the condition of the mentally ill patients.
* We assume that the sibling group intervention would be effective in reducing the family burden of the siblings, and that this reduction would be reflected in their replies to the "Experience of Caregiving Inventory".

Detailed description: * The group for siblings is an intervention which is carried out in the outpatient clinic of Lev HaSharon Mental Health Center in cycles which last eight weeks;
* Every group cycle will include between 10-14 participants, all siblings of persons with mental illness. The patients themselves (ill siblings) are either hospitalized in Lev HaSharon Mental Health Center, or are outpatients in the Lev HaSharon Mental Health Outpatient Unit, or in the community at large.
* The group is an ongoing group: short term intensive group intervention in a dynamic orientation. Veteran participants of each cycle are welcome to re-join at following cycles, and at the same time new participants can join at the beginning of each cycle.
* Participants will be asked to fill the "Experience of Caregiving Inventory" twice: first time before the first meeting of a particular cycle of sibling group and second time: after the last (eighth) meeting of this group cycle.

Eligibility criteria: Inclusion Criteria:

* siblings of persons with mental illness

Exclusion Criteria:

* persons junior then 18 years old

Primary outcomes:
measure: Score on the "Experience of Caregiving Inventory" following 8 weeks of participation in the group.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: Lev-HasharonMHC
Study officials:
affiliation: Lev-Hasharon Mental Healtlh Center
name: Igor Oyffe, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Melamed, S. Permission: A conceptual tool for treating mentally ill patients and their families. Journal of Family Psychotherapy. 12 (2). Pp. 29-42, 2001.
citation: Dixon L, McFarlane WR, Lefley H, Lucksted A, Cohen M, Falloon I, Mueser K, Miklowitz D, Solomon P, Sondheimer D. Evidence-based practices for services to families of people with psychiatric disabilities. Psychiatr Serv. 2001 Jul;52(7):903-10. doi: 10.1176/appi.ps.52.7.903.
Clinical trial NCT05836467: Is Myocardial Revascularization Really Necessary in Patients With ≥50-70% Coronary Stenosis Undergoing Valvular Surgery?
Official title: Is Myocardial Revascularization Really Necessary in Patients With ≥50-70% Coronary Stenosis Undergoing Valvular Surgery?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Heart Valve Diseases
Lead sponsor: Ospedale San Raffaele
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with any valvulopathy requiring sugery, with also critical coronary stenosis of 50-70% or more.

Brief summary: It is well documented in the literature that myocardial revascularization during valve surgery increases the risk of early mortality and morbidity.

According to the most recent version of the European Guidelines, the possibility of myocardial revascularization via coronary artery bypass should be evaluated in patients with an indication for surgical treatment of heart valve disease but with coronary artery stenosis ≥ 50-70%.

In this study, patients hospitalized for surgical heart valve disease, with occasional pre-operative finding of ≥ 50-70% coronary artery stenosis, without angina, are examined. After interdisciplinary discussion in the Heart Team, it was decided not to treat coronary artery disease during valve surgery. The aim is to evaluate the short and medium-term results of this "conscious omission".


Eligibility criteria: Inclusion Criteria:

* adult patients
* Presence of valve disease of surgical interest.
* Occasional pre-operative finding of coronary stenosis \>= 50-70%.

Exclusion Criteria:

* angina

Primary outcomes:
measure: Survival
timeFrame: through study completion, a minimum of 18 months
measure: Percutaneous revascularization risk
timeFrame: through study completion, a minimum of 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale San Raffaele - Cardiac Surgery Department
Study officials:
References:
Clinical trial NCT05801367: Allium Sativum Oil as Alternative Non-vital Pulpotomy Medicament in Primary Teeth
Official title: Allium Sativum Oil as Alternative Non-vital Pulpotomy Medicament in Primary Teeth- A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Non-Vital Tooth
Lead sponsor: University of Health Sciences Lahore
Sponsor class: OTHER
Collaborators: name: Lahore General Hospital
First posted: 2023-04-06
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized controlled clinical trial is to use Allium sativum oil as non-vital Pulpotomy medicament compared to Formocresol in primary teeth by evaluating its antibacterial effect against Streptococcus mutans and Lactobacillus acidophilus. It is hypothesized that there is no difference in the antibacterial effect of Allium sativum oil compared with Formocresol, when used as non-vital Pulpotomy medicaments.

Detailed description: It is a multi-arm parallel Randomized Controlled Trial in which forty patients aged between 4 to 8 years, each containing at-least one non-vital primary molar, will be selected and randomly divided into Group A (Formocresol) and Group B (Allium sativum oil). Non-vital Pulpotomy will be performed by removing the coronal necrotic pulp. Sterile paper point will be dipped in the root canals and taken to the laboratory. Cotton pellets soaked in the respective medicaments will be placed over the root canal orifices and filled temporarily. Patients will be recalled after one week. Samples will be again taken, and tooth restored. Comparison between bacterial count at baseline and after one week of treatment will be made and expressed as Colony-Forming Units/ml (CFU/ml).

Eligibility criteria: Inclusion Criteria:

1. Cooperation of patients and consent of parents.
2. Patients with ASA classification I and II (mild to moderate systemic disease).
3. Non-traumatic extensively carious hence restorable primary molars.
4. No history of antibiotic use for 2 weeks.
5. Presence of following clinical signs or symptoms suggestive of non-vital tooth such as tenderness on percussion, non-responsive to cold test, periapical/furcal radiolucency, localized gingival/mucosal soreness/redness/swelling, and/or slight mobility-grade I.

Exclusion Criteria:

1. History of allergy to anesthetics and latex.
2. Radiographic evidence of pulpal floor opening into the furcation area.
3. More than half of the roots resorbed.

Primary outcomes:
measure: Antibacterial effect
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: de' Montmorency College of dentistry
state: Punjab
Study officials:
affiliation: Assistant professor operative dentistry de, Montmorency College of Dentistry
name: Shazia Naz, BDS, MDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01572467: Studying Genes in Samples From Younger Patients With Ovarian or Testicular Sex Cord Stromal Tumors
Official title: DICER1 Mutations and miRNA in Ovarian and Testicular Sex Cord Stromal Tumors of Childhood
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Germ Cell Tumor
Leydig Cell Tumor
Ovarian Cancer
Keywords: Leydig cell tumor
ovarian stromal cancer
childhood malignant testicular germ cell tumor
childhood malignant ovarian germ cell tumor
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-04-06
Enrollment: 50
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients With Ovarian or Testicular Sex Cord Stromal Tumors

Brief summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify biomarkers related to cancer.

PURPOSE: This research trial is studying genes in tumor samples from younger patients with ovarian or testicular sex cord stromal tumors.

Detailed description: OBJECTIVES:

* To assess the role of DICER1 mutations and miRNA pathways in the etiology and progression of ovarian or testicular sex cord stromal tumors.

OUTLINE: Archived tumor tissue samples are analyzed for D1CER1 mutation and mRNA expression by reverse-transcriptase polymerase chain reaction (RT-PCR) and laser micro dissector. Results are then correlated with medical data, including age at diagnosis, diagnosis, pathology report, presenting symptoms, family history, treatment, outcome, and length of follow-up, when available.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Fixed and frozen tissue samples from the ATBR01 B1 tissue bank and from the International Pleuropulmonary Blastoma Registry, Children's Hospital of Boston, and Massachusetts General Hospital
* Tissue samples from patients diagnosed with:

  * Ovarian

    * Sertoli-Leydig cell tumor
    * Juvenile granulosa cell tumor
    * Adult granulosa cell tumor
    * Gynandroblastoma
    * Sex cord stromal tumor with annular tubules
    * Sex cord stromal tumor, undifferentiated
    * Sertoli tumor
    * Leydig tumor
  * Testicular:

    * Granulosa cell tumor
    * Sertoli tumor
    * Leydig tumor
    * Sertoli-Leydig
    * Undifferentiated stromal tumor

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Correlation between DICER1 mutations and miRNA pathways with outcomes using descriptive analysis
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Children's National Research Institute
name: Dana A. Hill, MD
role: PRINCIPAL_INVESTIGATOR
References: