louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05659758: Is Effective Preoxygenation in Elderly Patients Related to Position?
Official title: Is Effective Preoxygenation in Elderly Patients Related to Position?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia Intubation Complication
Keywords: preoxygenation, elderly
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 156
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the effect of the head-up position of 20 and 30 degrees on the ETO2 reaching time of 85% and the desaturation time of 92% after intubation in elderly patients compared to the supine position.

Detailed description: Patients will be randomized into 3 groups. The patients will lay in the supine position, in the control group and 20 and 30 degrees head up position in other two groups. Each patient will be preoxygenated with well fitting anaesthesia face mask with FiO2 of 100% at least 6L of flow until the ETO2 reaches concentration of 85%. The angle (20 or 30 degrees) formed by the patients' bodies (hips and feet parallel to the ground, lifting the back from the ground plane) with the ground will be measured with a spirit level, angle meter, and confirmed with a smartphone application. The time to reach ETO2 85% by starting preoxygenation in patients will be measured and recorded with a stopwatch. When the target is reached, anesthesia induction will be performed and the patients will be intubated. After the start of the intubation attempt, the stopwatch will be started again, after intubation, the patient will be ventilated with a balloon once and the location of the tube will be confirmed, the circuit will be separated and SpO2 will be expected to go down to the level of 92 % and recorded during this time.

Eligibility criteria: Inclusion Criteria:

* Age above 65 years
* ASA 1-2

Exclusion Criteria:

* heart failure
* uncooperative
* patients refusing well fitting face mask before reaching EtO2 85%
* chronic lung disease
* anemia (hb\<8gr/dl)
* BMI\>40
* neurological sequela

Primary outcomes:
measure: Time ETO2 85%
timeFrame: Time between placement of face mask and end tidal oxygen concentration reaches 85 %
Secondary outcomes:
measure: Desaturation time
timeFrame: Time between initiation laryngoscopy for endotracheal intubation and peripheral oxygen saturation reaches 92 % measured by pulseoxymeter
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent City Hospital
Study officials:
References:
Clinical trial NCT01013558: New Options for Preoperative Anesthesia in Intrauterine Needling
Official title: NO PAIN: New Options for Preoperative Anesthesia in Intrauterine Needling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stress
Pain
Keywords: fetal pain
intrauterine
needling
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Leuven University Medical Center
First posted: 2009-11-13
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The concept of fetal pain is becoming increasingly relevant due to growing possibilities for invasive intrauterine treatment. There is much debate as to whether the fetus is mature enough to be able to perceive pain at all. Recent studies have suggested that the fetus is at least capable of exhibiting a stress response to intrauterine needling. Intrauterine transfusions are most commonly performed by inserting a needle either in the umbilical cord root at the placental surface, or in the intrahepatic portion of the umbilical vein of the fetus. Recently, intrauterine needling in the intrahepatic vein has been shown to result in alterations in fetal stress hormones, which has been interpreted as a reaction to pain. These changes were not observed in intrauterine needling in the umbilical cord root, or after administration of analgesics to the fetus. The investigators tested the hypothesis that remifentanil provides fetal analgesia, assessed by a reduced fetal stress response. The investigators performed a randomised controlled trial comparing fetal stress response between patients undergoing intrauterine transfusions for alloimmune fetal anemia receiving remifentanil, or placebo.


Eligibility criteria: Inclusion Criteria:

* singleton pregnancy
* clinically indicated intrauterine transfusion
* red cell alloimmunisation

Exclusion Criteria:

* severe adipositas
* suspicion of structural anomalies
* fetal hydrops
* contraindication for remifentanil

Primary outcomes:
measure: evidence of fetal stress response by changes in fetal stress hormones beta-endorphin, noradrenalin and cortisol
timeFrame: 15-60 minutes
Secondary outcomes:
measure: influence of analgesics (remifentanil) on the fetal stress response
timeFrame: 15-60 minutes
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
Study officials:
affiliation: Leiden University Medical Center
name: Frank P.H.A. Vandenbussche, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andrewartha K, Grivell RM. Perioperative pharmacological interventions for fetal immobilisation during fetal surgery and invasive procedures. Cochrane Database Syst Rev. 2022 May 13;5(5):CD011068. doi: 10.1002/14651858.CD011068.pub2.
Clinical trial NCT00047658: A Study of the Safety and Clinical Effects of Interferon Gamma-1b in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety, Biology, and Clinical Effects of Interferon Gamma-1b Administered Subcutaneously to Patients With IPF Followed by an Open-Label Extension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: InterMune
Sponsor class: INDUSTRY
First posted: 2002-10-11
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study GIPF-002 is a phase 2 study designed to characterize the biologic and clinical effects of IFN-g 1b. The objective of the Study is to characterize the biologic and clinical effects of IFN-g 1b administered to patients with idiopathic pulmonary fibrosis (IPF). The Study will be conducted at multiple sites and enroll 30 patients with IPF who have failed treatment with corticosteroids.


Eligibility criteria: Male or Female 20-79 years old

Primary outcomes:
measure: change in percent predicted FVC, resting arterial blood gas assessment of alveolar-arterial oxygen gradient, percent predicted DLCO, dyspnea scale, baseline dyspnea index/transition dyspnea index
timeFrame: 23 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA, Dept. of Medicine
state: California
Study officials:
affiliation: InterMune
name: Williamson Bradford, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01468558: Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole
Official title: A Phase I Evaluation of the Effect of Ketoconazole on the Pharmacokinetics and Safety of Dihydroergotamine Mesylate (DHE) Delivered by Oral Inhalation (MAP0004) in Healthy Volunteers Compared to DHE Delivered Intravenously (DHE 45®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Drug Drug Interaction Study in Normal Healthy Volunteers
Lead sponsor: Allergan
Sponsor class: INDUSTRY
Collaborators: name: MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan
First posted: 2011-11-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Compare the DHE pharmacokinetic profiles observed following administration of:

1. MAP0004 (oral inhalation DHE)
2. MAP0004 co-administered with oral Ketoconazole
3. Intravenous (IV) DHE (D.H.E.45®, the approved reference therapy)

Compare the tolerability of MAP0004, IV DHE, and MAP0004 with co-administration of Ketoconazole.


Eligibility criteria: Major Inclusion Criteria:

* Able to provide written Informed Consent
* Male or Female subjects 18 to 45 years old
* Female subjects who are practicing adequate contraception or who are sterile
* Stable cardiac status
* Normal rhythm or arrhythmia deemed clinically insignificant on ECG

Exclusion Criteria:

* Contraindication to dihydroergotamine mesylate (DHE)
* Use of any excluded concomitant medications within the 10 days prior to Visit 1
* History of hemiplegic or basilar migraine
* Participation in another investigational trial during the 12 weeks prior to Visit 1 or during this trial

Primary outcomes:
measure: Cmax of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration
timeFrame: 48 hours
measure: AUC(0-48) of Dihydroergotamine After MAP0004, MAP0004 Co-administered With Ketoconazole, and IV DHE Administration
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Merthyr Tydfil
country: United Kingdom
facility: Simbec Research Limited
Study officials:
References:
citation: Kellerman D, Kori S, Forst A, Chang J, Febbraro S, Wutann L, Thomas T, Taylor G, Dodick D. Lack of drug interaction between the migraine drug MAP0004 (orally inhaled dihydroergotamine) and a CYP3A4 inhibitor in humans. Cephalalgia. 2012 Jan;32(2):150-8. doi: 10.1177/0333102411432299. Epub 2011 Dec 15.
Clinical trial NCT02009358: Mental Health Promotion Interventions Among Migrant Workers in China
Official title: Mental Health Promotion Interventions for Reducing Self-reported Depression and Improving Rates of Early Detection of Depression Among Migrant Workers in China, a Cluster Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Keywords: mental health promotion
depression
migrant workers
China
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2013-12-12
Enrollment: 913
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goals of this research were to conduct a mental health intervention study for reducing self-reported depression and anxiety among migrant workers in a labor-intensive industry in China and to assess the effectiveness of the integrated mental health interventions aimed at promoting the mental health of migrant workers in labor-intensive industries in China.


Eligibility criteria: Inclusion Criteria:

* People who worked in the factory agreed to take participant in this study and could understand the questionnaire.

Exclusion Criteria:

* People who don't want to take participant in the study; People can not understand the questionnaire.

Primary outcomes:
measure: Reducing rate of self-reported depression in BDI
timeFrame: Change from baseline to one year after
Secondary outcomes:
measure: Reducing rate of early detection of depression
timeFrame: change from baseline to one year after
Other outcomes:
measure: Reducing rate of self-reported anxiety in BAI
timeFrame: change from baseline to one year after
Locations:
Study officials:
affiliation: +86 13910229255
name: Xin Yu, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05966558: Cesarean Section Scar Niche: The Impact on Assisted Reproductive Technology Outcome
Official title: Cesarean Section Scar Niche: The Impact on Assisted Reproductive Technology Outcome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cesarean Section Niche Impact on ART
Keywords: Cesarean Section niche
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2023-07-28
Enrollment: 266
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 37
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: It will be carried out in the department of Obstetrics and Gynecology, Zagazig University and in a private center.

Brief summary: the presence of cesarean section niche has adverse effects on success of ART outcome

Detailed description: A common finding by ultrasound in secondary infertility patients with previous cesarean sections is the presence of niche, which is formally defined as an indentation of the uterine myometrium of at least 2 mm at the site of the caesarean scar. The most common symptom of niche is abnormal uterine bleeding, other symptoms include dysmenorrhea, chronic pelvic pain, dyspareunia, and sub-fertility/infertility.

It has been reported that a niche can reduce the chances of embryo implantation and may lead to spontaneous miscarriages if the implantation is close to or in the niche. The presence of a niche may render the actual embryo transfer procedure technically more difficult, and clinicians need to be aware of its presence and perform the transfer under ultrasound guidance to ensure the catheter bypasses the niche and enters the uterine cavity. Still the impact of c.s niche and its characteristics on outcome of ART is not clear.

Eligibility criteria: Inclusion Criteria:

* All women should have the following:

  * Aged from 18 - 37 years old.
  * Undergoing fresh ICSI cycles.
  * A normal uterus with no anomalies or pathologies.
  * At least one good-quality embryo/blastocyst available for transfer (3 BB and more according to Gardner and Schoolcraft grading system).
  * Easy mockup embryo transfer (i.e. the catheter is smoothly inserted without touching the fundus, no cervix tenaculum is used and the catheter is clean of blood).

Exclusion Criteria:

* Younger than 18 or older than 37 years old.
* Congenital uterine abnormality or pathology.
* Presence of a hydrosalpinx.
* Chronic diseases which are not suitable for pregnancy.
* ICSI cycles with fresh or frozen TESE samples.

Primary outcomes:
measure: The Effect of cesarean section scar niche on ongoing pregnancy rate in ART cycles.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig university
Study officials:
References:
Clinical trial NCT01257958: Vitamin D Pilot Study in Patients With Multiple Sclerosis
Official title: Vitamin D Pilot Study in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Vitamin D, 19 nor Vitamin D, Multiple Sclerosis
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2010-12-10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Phase 1 study of 19-nor Vitamin D in relapsing-remitting MS. Primary measure is MRI.


Eligibility criteria: Inclusion Criteria:

* relapsing remitting MS

Exclusion Criteria:

* MRI contraindicated

Primary outcomes:
measure: MRI Measure of new active lesions, observation vs. treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW-Madison
state: Wisconsin
Study officials:
References:
Clinical trial NCT01898858: Effects of O2 and/or CO2 Inhalation on Rest and Exercise Pulmonary Hemodynamic
Official title: Effects of O2 and/or CO2 Inhalation on Rest and Exercise Pulmonary Hemodynamic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Vascular Sensibility in Hypoxia
Hypercapnia
Hypoxia and Hypercapnia
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2013-07-12
Enrollment: 8
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: The aim of this study is to describe the pulmonary hemodynamic evolution at rest and during a short constant load exercise in 4 conditions :

* normoxia
* hypoxia
* hypercapnia
* association hypoxia and hypercapnia


Eligibility criteria: Inclusion criteria:

* healthy male
* exercise capacity between 100 and 130 % of theorical values

Exclusion criteria:

* smoker
* headache
* impossibility to perform an exercise test
* no tricuspid regurgitation on the echocardiography

Primary outcomes:
measure: Systolic Artery Pulmonary Pressure(sPAP) (echocardiography, Cardiac output (impedancemetry), Cardiorespiratory parameters
timeFrame: at the end of the 30th minutes constant load exercise
Secondary outcomes:
measure: Dyspnea and muscle leg discomfort using a Borg Scale
timeFrame: at the end of the 30th minutes constant load exercise
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Physiologie et d'Explorations Fonctionnelles, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: PISTEA Cristina, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05113758: Sarcopenia Measured by Ultrasound in Hospitalized Older Adults
Official title: "SARCOPENIA MEASURED BY ULTRASOUND IN HOSPITALIZED OLDER ADULTS" (ECOSARC Study).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcopenia
Keywords: sarcopenia
ultrasound
aged
hospitalized
Lead sponsor: Complejo Hospitalario Universitario de Albacete
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Getafe
name: Hospital Infanta Sofia
name: Hospital Universitario Infanta Leonor
name: Hospital Universitario La Paz
name: Puerta de Hierro University Hospital
name: Hospital Virgen del Valle de Toledo
First posted: 2021-11-09
Enrollment: 161
Sex: ALL
Minimum age (years): 69
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 69 years of age admitted to Acute Geriatric Units.

Brief summary: Observational prospective study in older adults admitted to an Acute Geriatric Unit, in which sarcopenia will be evaluated by ultrasound in the anterior rectus femoris muscle.

Detailed description: The main objective of the study is to estimate, by means of portable ultrasound, parameters of muscle quantity and quality (anterior rectus femoris muscle area, width and echostructure ) in older adults hospitalized in Acute Geriatric Units for medical reasons.

Eligibility criteria: Inclusion Criteria:

* Patients over 69 years of age.
* Hospitalization for a medical cause in Acute Geriatric Units.
* Holden's Functional Ambulation Classification Scale at level 1 or higher.
* Informed consent signed by the patient or legal representative.

Exclusion Criteria:

* Terminal condition or life expectancy of less than 6 months.
* Impossibility or refusal to undergo muscle ultrasound.
* Refusal for follow-up
* Severe dementia stage Global Deteriorating Scale: 7
* Impossibility in the opinion of the investigators to complete the necessary data for the study.

Primary outcomes:
measure: Prevalence of sarcopenia on admission
timeFrame: 72 hours
measure: Incidence of sarcopenia between admission and discharge
timeFrame: 15 days
measure: Muscle mass (the anterior rectus femoris muscle)
timeFrame: 15 days
Secondary outcomes:
measure: Minimal nutritional assessment (MNA-SF) score
timeFrame: 72 hours
measure: Hand grip strength
timeFrame: 15 days
measure: 4-meter walking speed test
timeFrame: 15 days
measure: ADL (Activities of Daily Living) questionnaire
timeFrame: 3 months
measure: SPPB score (SHORT PHYSICAL PERFORMANCE BATTERY score)
timeFrame: 15 days
measure: Mortality
timeFrame: 3 months
measure: Length of stay, days
timeFrame: 15 days
measure: Readmission(s) after index hospitalization
timeFrame: 3 months
measure: Emergency department (ED) visit(s)
timeFrame: 3 months
Other outcomes:
Locations:
city: Albacete
country: Spain
facility: Complejo Hospitalario Universitario de Albacete
Study officials:
affiliation: Complejo Hospitalario Universitario de Albacete (SESCAM)
name: Pedro Abizanda, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04983758: 20-year Implant Survival in Periodontally Healthy and Compromised Patients
Official title: Long-term (20-year) Implant Survival and Success Rates in Patients Healthy and Compromised Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dental Implant Failed
Peri-Implantitis
Bone Loss
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2021-07-30
Enrollment: 149
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients attending the principle investigator (M.R.), a specialist in periodontology, for dental implant therapy between December 1998 and September 2001 were screened for possible inclusion in the study.

Brief summary: The aim of this study will be to compare the long-term outcomes of sandblasted and acid-etched (SLA) implants in patients previously treated for periodontitis and in periodontally healthy patients (PHP) after a follow-up of at least 20-years.


Eligibility criteria: Inclusion Criteria:

* complete edentulism;
* presence of an implant-supported overdenture;
* mucosal diseases;
* alcohol and drug abuse;
* pregnancy;
* uncontrolled metabolic disorders;
* aggressive periodontitis;
* no interest in participating in the study

Exclusion Criteria:

* Everything not as Inclusion Criteria

Primary outcomes:
measure: Implant survival rate
timeFrame: Baseline; 10-year at the 20-year follow-up examination
Secondary outcomes:
measure: Marginal Bone loss
timeFrame: Baseline; 10-year at the 20-year follow-up examination
Other outcomes:
Locations:
city: Torino
country: Italy
facility: University of Torino
Study officials:
References: