louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00313937: SAM - Skip a Meal - Insulin Glargine, Diabetes Mellitus Type 1
Official title: Single Centre, Open, Controlled, Randomised (1:1), Parallel Group: Insulin Glargine vs. NPH: FPG (Fasting Plasma Glucose) in Patients With DM Type 1 Who Skip the Morning Meal During Treatment With MDI (Multiple Daily Injection) Basal/Bolus Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-04-12
Enrollment: 91
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: Primary objective:

To compare metabolic control as measured by Blood Glucose (BG) upon arising from bed (7:00 am - 12:00 pm) in type 1 Diabetes mellitus patients who skip the morning meal during treatment with MDI basal/bolus insulin: Difference of change of blood glucose between 7:00 am and 11:00 am between patients on Insulin glargine and NPH insulin.

Secondary objective:

To perform an evaluation between the two patient groups for BG (10:00 pm and 12:00 pm) as well as for serum insulin, free fatty acid levels and β-hydroxybutyrate (7:00 am - 12:00 pm).


Eligibility criteria: Inclusion Criteria:

Patients with type 1 Diabetes mellitus who have been treated with MDI (Multiple Daily Injection) basal/bolus insulin, regular insulin/short acting insulin analogue + NPH insulin on a stable dose (no change more than 10 %) for at least 4 weeks prior to study entry, who have an HBA1c smaller/equal 9 % (measured at visit 1) and a BMI smaller/equal 35 kg/m2. In addition, patients must have a FBG value at day 1 before skipping meal (6:00 am - 07:00 am) between 90 - 120 mg/dl (5.0 - 6.5 mmol/l).

Exclusion Criteria:

* Breast-feeding
* History of hypersensitivity to the study medication or to drugs with similar chemical structures
* Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol
* Treatment with any investigational drug in the last 30 days before study entry
* Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
* History of drug or alcohol abuse

No subjects who have previously been treated with Insulin glargine will be enrolled in this study.

Primary outcomes:
measure: Difference of change of blood glucose between patients on Insulin glargine and NPH insulin.
timeFrame: between 7:00 am and 11:00 am
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Wolfgang Landgraf, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02877537: Measurement of Respiratory Admittance for Pediatric Asthma Diagnosis
Official title: Measurements of Change of Respiratory Admittance Induced by Salbutamol for Pediatric Asthma Diagnosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 177
Sex: ALL
Minimum age (years): 3
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose is to characterize the change of respiratory admittance induced by salbutamol inhalation in children and young adults. A variation threshold will be fixed to distinguish asthmatic and healthy subjects.

This project could allow a better identification of asthmatic individuals needing a treatment, a reduction of morbidity of asthma, a reduction of unnecessary treatments administered in individuals with respiratory but not asthmatic symptoms, a better comprehension of bronchial hyperreactivity and its role in asthmatic disease.


Eligibility criteria: Inclusion Criteria:

Asthmatic children group:

* Several episodes of paroxysmal wheezes, spontaneous or after exercise, without bronchial-pulmonary infection
* Absence of bronchodilator taking during last 12 hours
* Absence of reported intolerance to adrenergic substances
* Parental authorization and consent of child to participate to the study

Control children group:

- Parental authorization and consent of child to participate to the study

Control adult group:

- Consent to participate to the study

Exclusion Criteria:

Control children and adult groups:

* At least 2 episodes of wheezes during breathing
* Several wheezes, abnormal breathlessness, cough during physical exercise
* Asthma diagnosed by family doctor
* Administration of drugs to treat asthma
* Eczema or food allergy at inclusion
* Episode of cough for longer than 6 weeks, without bronchial infection
* Bronchitis, throat infection, rhino-pharyngitis during last 15 days
* Paleness or cyanosis with loss of consciousness when the child was a baby or during an exercise

Primary outcomes:
measure: Ventilatory mechanical impedance
timeFrame: day 0
measure: Thoracic gas volume
timeFrame: day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: CHU de Nancy - Hôpital BRABOIS Enfants - Explorations fonctionnelles pédiatriques
Study officials:
affiliation: CHU de Nancy - Hôpital BRABOIS Enfants - Explorations fonctionnelles pédiatriques
name: François MARCHAL
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04398537: The Role of Pre-deployment Retraction in Decreasing Biopsy Clip Migration During Stereotactic Breast Biopsies
Official title: The Role of Pre-deployment Retraction in Decreasing Biopsy Clip Migration During Stereotactic Breast Biopsies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Biopsy
Keywords: stereostatic procedure
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 245
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This will be a single-center prospective randomized control trial that is Institutional Review Board (IRB) approved. The study plans to enroll 250 female patients presenting to the University of Alabama at Birmingham (UAB) for stereotactic biopsy. This study is a prospective and will target approximately 250 patients. This will be a HIPPA-compliant randomized control trial planned on spanning approximately six months' time. Patients will be entered into the study only based on their already scheduled stereotactic biopsy procedure. Patients will be informed of the study and they will be offered the opportunity to participate or not participate in the study. Their participation is completely voluntary. This study will not involve any intervention that is not already a part of standard care. Patients will be randomized to two groups, one group that will undergo clip placement with approximately with a 5 mm retraction of the biopsy clip post-placement and one that will involve no retraction prior to deployment.


Eligibility criteria: Inclusion Criteria:

- Females 18-99 of age with recommendation for stereotactic biopsy.

Exclusion Criteria:

* Non-female patients
* Patients \< 18 years old
* Women who are pregnant

Primary outcomes:
measure: Number of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site.
timeFrame: baseline through 1 hour (post biopsy mammogram/procedure)
measure: Percentage of Breast Biopsy Patients Whose Clip Migrated Greater Than 10mm From the Biopsy Site.
timeFrame: baseline through 1 hour (post biopsy mammogram/procedure)
measure: Average Distance of Clip Migration for the Arm That Received 5mm Retraction.
timeFrame: baseline through 1 hour (post biopsy mammogram/procedure)
measure: Average Distance of Clip Migration for the Arm That Did Not Receive Clip Retraction.
timeFrame: baseline through 1 hour (post biopsy mammogram/procedure)
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Stefanie Woodard, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05064137: Clinical Efficacy of Different Remineralizing Agents in Treatment of White Spot Lesions
Official title: Clinical Efficacy of Different Remineralizing Agents in Treatment of White Spot Lesions Among a Group of Egyptian Children : A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Remineralization
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 30
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the present study is to evaluate the efficiency of Self-assembling Peptide P11-4, Tricalcium Phosphate Fluoride Varnish, 5% F- and 5% fluoride varnish in remineralization of WSLs in primary dentition among a group of Egyptian children.


Eligibility criteria: Inclusion Criteria:

* Apparently healthy cooperative children
* Aging from 3-5 years old child
* Both genders
* Primary teeth with active WSLs on buccal or labial surfaces
* Patient and parent acceptance to treatment and maintenance of good oral hygiene

Exclusion Criteria:

* Restored teeth
* White spot lesions due to fluorosis
* Teeth with hypoplasia
* Lesions that require an invasive treatment
* Any pathology or concomitant medication affecting salivary flow or causing dry mouth

Primary outcomes:
measure: Size of WSL ( white spot lesion )
timeFrame: through study completion, an average of 8 months
Secondary outcomes:
measure: Regression of caries
timeFrame: through study completion, an average of 8 months
measure: Inactivation of active carious lesions
timeFrame: through study completion, an average of 8 months
measure: Mineral content of WSL
timeFrame: through study completion, an average of 8 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01818037: Long-term Postoperative Outcomes After Bilateral Congenital Cataract Surgery in Eyes With Microphthalmos
Official title: A Long-term Postoperative Outcome After Bilateral Congenital Cataract Surgery in Eyes With Microphthalmos
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Microphthalmos With Congenital Cataracts
Lead sponsor: Iladevi Cataract and IOL Research Center
Sponsor class: OTHER
First posted: 2013-03-26
Enrollment: 36
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 72 eyes of 36 patients with microphthalmos who underwent bilateral congenital cataract surgery between January 2003 and June 2008.

Brief summary: Cataract surgery in infantile eyes, which are microphthalmic, can be even more demanding.

In addition, the frequent presence of other ocular and systemic anomalies such as nystagmus, glaucoma, amblyopia, and higher rate of postoperative complications may limit the success of cataract surgery.

In our previous study, the investigators examined the intraoperative performance and postoperative outcomes of bilateral cataract surgery in microphthalmic eyes of patients before their first birthday. At 1 year, the postoperative results showed that good visual outcomes could be obtained in microphthalmic eyes.

Since only a few studies have reported outcomes, and that too only short term of cataract surgery on microphthalmic eyes, in this prospective observational study we evaluated the long-term impact of bilateral cataract surgery on eyes with microphthalmos. The investigators examined the outcomes, complication rates, influence of age at surgery on pattern of axial growth and central corneal thickness and visual and orthoptic assessment in these eyes.


Eligibility criteria: Inclusion Criteria:

* Presence of microphthalmos and congenital cataract.
* Microphthalmos was defined as an eye with an axial length (AL) that is more than 2 SD smaller than the normal for that age group according to Gordon and Donzes

Exclusion Criteria:

- Children with congenital anomalies such as posterior persistent fetal vasculature causing stretching of the ciliary processes or a tractional retinal detachment, aniridia, and chorioretinal coloboma were excluded.

Primary outcomes:
measure: Glaucoma following cataract surgery
timeFrame: 45 months postoperative
Secondary outcomes:
measure: Posterior synechiae
timeFrame: 45 months postoperatively
measure: visual axis obscuration
timeFrame: 45 months
measure: axial length rate of growth
timeFrame: 45 months postoperatively
measure: central corneal thickness
timeFrame: 45 months postoperatively
measure: visual acuity
timeFrame: 45 months postoperatively
Other outcomes:
Locations:
city: Ahmedabad
country: India
facility: Iladevi Cataract & IOL Research Center
state: Gujarat
Study officials:
References:
Clinical trial NCT00232037: Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
Official title: Extension Study to Assess the Long-Term Safety of Tegaserod in Women With Symptoms of Dyspepsia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dyspepsia
Keywords: Dyspepsia, gastrointestinal, tegaserod
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-04
Enrollment: 359
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is being done to evaluate the long-term safety of tegaserod in women with symptoms of dyspepsia who have completed the core study. Tegaserod will be evaluated at 6 mg twice daily.


Eligibility criteria: Inclusion Criteria:

* Female, 18 years and older
* Fulfilled eligibility criteria in CHTF919D2301 (double blind study) and successfully completed the double-blind study

Exclusion Criteria:

- Early discontinuation from the double-blind study

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Long term safety at 6 months.
Secondary outcomes:
measure: Long term safety at 1 year.
measure: Quality of life : Nepean Dyspepsia Index, WPAI, patient perception of study medication-dyspepsia questionaire.
measure: Efficacy on satisfactory relief at month 6 and 12.
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: East Hanover NJ
name: Novartis
role: STUDY_CHAIR
References:
Clinical trial NCT05932537: Ablation of Subcutaneous Contraceptive Implants in the Operating Room
Official title: Technical Description of the Ablation of Subcutaneous Contraceptive Implants in the Operating Room
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Contraceptive Usage
Keywords: subcutaneous contraceptive implants
ablation
operating room
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 50
Sex: FEMALE
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: This study covers all patients who underwent explantation of a subcutaneous contraceptive implant in the gynecology operating room of the Hôpital Femme Mère Enfant, between 2018 and 2022.

Brief summary: The ablation of subcutaneous contraceptive implants is usually performed in consultation under local anesthesia. However, it happens that the implant was placed too deeply or that it migrated too deeply making it impossible to remove it in consultation. These patients should then be referred to reference centers so that the explantation takes place in the operating room. The investigators propose to describe their techniques for preoperative visualization of the implant and their techniques for surgical explantation for educational purposes.


Eligibility criteria: Inclusion Criteria:

* women over 18
* patient who underwent explantation of a subcutaneous contraceptive implant in the gynecology operating room
* intervention between 2018 and 2022
* person having expressed his non-opposition

Exclusion Criteria:

* explantation outside the operating room
* inability to understand the information given
* person deprived of liberty
* person under guardianship

Primary outcomes:
measure: Ultrasound for visualization of implants
timeFrame: preoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Gynaecology Department, Hôpital Femme Mère Enfant, Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT04815837: An Online Intervention Promoting HPV Vaccination Among Chinese MSM
Official title: An Evidence-based Knowledge Transfer Program Promoting Human Papillomavirus (HPV) Vaccination Among Men Who Have Sex With Men in Hong Kong
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaccine Refusal
Keywords: HPV vaccination
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-03-25
Enrollment: 350
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Hong Kong Chinese speaking men who have sex with men completed a baseline survey, and then received an online intervention promoting uptake of Human Papillomavirus (HPV) vaccination. All participants are followed up by telephone 12 months after the completion of baseline survey.

Detailed description: The primary objective of this study is to investigate prevalence of uptake of Human Papillomavirus (HPV) vaccination after exposure to health promotion among men who have sex with men in Hong Kong within a 12-month project period.

Inclusion criteria are Hong Kong Chinese speaking males aged 18-45 years old and self-reported having had oral or anal intercourse with at least one man in the last six months. Those who have ever received HPV vaccination are excluded.

Participants are recruited through outreaching in gay venues, online advertisement and referral made by peers and non-governmental organization. With verbal informed consent, participants completed a baseline survey through telephone. They are then exposed to online interventions including: 1) watching an online video, 2) receiving a discount coupon to receive HPV vaccination at collaborative private clinics, 3) visiting the project webpage, and 4) receiving follow-up reminders 1, 2, 4, 6, and 8 months after the baseline survey.

All participants are followed up by telephone 12 months after the baseline survey to access the primary outcome.

Eligibility criteria: Inclusion Criteria:

* Hong Kong Chinese speaking males aged 18-45 years old and self-reported having had oral or anal intercourse with at least one man in the last six months

Exclusion Criteria:

* Have received any HPV vaccination

Primary outcomes:
measure: Taking up at least one dose of Human Papillomavirus (HPV) vaccination in the past year
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Centre for Health Behaviours Research, the Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Zixin Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06847737: Prediction of Hypotension After Spinal Anesthesia in Cesarean Sections Using Non-Invasive Measurement Methods
Official title: Prediction of Hypotension After Spinal Anesthesia in Cesarean Sections Using Non-Invasive Measurement Methods: Comparative Analysis of Perfusion Index, Pulse Variability Index, Tissue Oxygen Saturation and Tissue Hemoglobin Index
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Postspinal Hypotension
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2025-02-26
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Fifty pregnant women over the age of 18 who underwent elective cesarean section, were American Society of Anesthesia I and II, and agreed to participate in the study.

Brief summary: To compare the incidence of hypotension after spinal anesthesia and the values of perfusion index, pleth variability index, tissue oxygen saturation and tissue hemoglobin index between those who developed hypotension and those who did not develop hypotension over time.


Eligibility criteria: Inclusion Criteria:

* Those who underwent elective cesarean section over the age of 18,
* American Society of Anesthesia I and II,
* Agree to participate in the study,

Exclusion Criteria:

* \<18 or \>45 years,
* preeclampsia,
* cardiovascular disorders,
* fetal abnormalities,
* not undergoing spinal anesthesia or undergoing general anesthesia during surgery,
* not agreeing to participate in the study

Primary outcomes:
measure: tissue oxygen saturation
timeFrame: 4 month
measure: tissue hemoglobin index
timeFrame: 4 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istinye Üniversity
state: Merkez Mahallesi
Study officials:
References:
citation: Ilies C, Kiskalt H, Siedenhans D, Meybohm P, Steinfath M, Bein B, Hanss R. Detection of hypotension during Caesarean section with continuous non-invasive arterial pressure device or intermittent oscillometric arterial pressure measurement. Br J Anaesth. 2012 Sep;109(3):413-9. doi: 10.1093/bja/aes224. Epub 2012 Jul 12.
citation: Kuwata S, Suehiro K, Juri T, Tsujimoto S, Mukai A, Tanaka K, Yamada T, Mori T, Nishikawa K. Pleth variability index can predict spinal anaesthesia-induced hypotension in patients undergoing caesarean delivery. Acta Anaesthesiol Scand. 2018 Jan;62(1):75-84. doi: 10.1111/aas.13012. Epub 2017 Oct 16.
citation: Duggappa DR, Lokesh M, Dixit A, Paul R, Raghavendra Rao RS, Prabha P. Perfusion index as a predictor of hypotension following spinal anaesthesia in lower segment caesarean section. Indian J Anaesth. 2017 Aug;61(8):649-654. doi: 10.4103/ija.IJA_429_16.