louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06327165: Predictability of ANI (Analgesia Nociception Index) for Spinal Hypotension
Official title: Predictability of ANI (Analgesia Nociception Index) for Hypotension After Spinal Anesthesia in Patients Undergoing Cesarean Section
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cesarean Section
Spinal Anesthesia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-03-25
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ANI monitor will be applied to all patients, but will be covered with black papar so that it could not be observed during anesthesia. ANI data recorded at 1 second intervals will be downloaded at the end of anesthesia.

Brief summary: Spinal anesthesia is widely accepted as the anesthetic method of choice for Cesarean section. However, the incidence of spinal hypotension is 50-70%, and the decrease in blood pressure is often rapid and severe. Heart rate variability is influenced by various factors such as the sympathetic nervous system, parasympathetic nervous system, temperature regulation, baroreflex, and endocrine regulation, but high frequency heart rate variability above 0.15 Hz very specifically reflects the parasympathetic nervous system. The ANI monitor calculates heart rate variability mediated by changes in the parasympathetic nervous system. This study aims to determine whether ANI monitor can predict hypotension in patients undergoing a caesarean section under spinal anaesthesia while applying the preemptive vasopressor phenylephrine infusion protocol.


Eligibility criteria: Inclusion Criteria:

* full-term parturients undergoing cesarean delivery

Exclusion Criteria:

* emergent surgery, placenta previa, Morbid obesity with a BMI ≥ 40 kg/m2, Gestational age \< 36 or ≥ 41 weeks, Contraindications to spinal anesthesia, cardiac arrhythmia, implantable pacemaker, diseases affecting the autoimmune system (such as immune disease or diabetic neuropathy), use of medications affecting ANI monitoring (antimuscarinics, alpha-agonists, beta blockers), illiteracy, or foreigners

Primary outcomes:
measure: predictive value of ANI monitor for spinal hypotension during cesarean delivery
timeFrame: the occurence of hypotension at (within) 1 hour after spinal anesthesia
Secondary outcomes:
measure: Optimal cutoff value of ANI level for predicting occurrence of hypotension
timeFrame: the occurence of hypotension at (within) 1 hour after spinal anesthesia
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health system, Severance Hospital
Study officials:
References:
Clinical trial NCT00265265: Assessment of Potential Interactions Between Intravenous Cocaine and Atomoxetine - 1
Official title: Phase 1, Double-Blind, Placebo-Controlled Multiple Dose Assessment of Potential Interactions Between Intravenous Cocaine and Atomoxetine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cocaine-Related Disorders
Keywords: Cocaine Dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2005-12-14
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess potential interactions between intravenous (i.v.) cocaine and atomoxetine (Strattera) administered orally in four escalating doses.


Eligibility criteria: Inclusion Criteria:

* 18-45 years of age who are not seeking treatment at the time of the study
* Must be able to provide written informed consent
* Must be within 20 percent of ideal body weight and weigh at least 45 kg
* Must meet DSM0IV diagnostic criteria for cocaine abuse or dependence
* Must currently be using cocaine as confirmed by a positive BE
* If female and of child bearing potential, must agree to the use of birth control

Exclusion Criteria:

- please contact the site directly for more information

Primary outcomes:
measure: Safety
measure: Cardiovascular responses
Secondary outcomes:
measure: Cocaine craving
measure: pharmacokinetic assessment
measure: Psychological Effects of Cocaine
measure: Abuse Liability
measure: Mood and personality assessments
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Uniformed Services University of Health Science
state: Maryland
Study officials:
affiliation: Uniformed Services University of Health Science
name: Louis Cantilena, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cantilena L, Kahn R, Duncan CC, Li SH, Anderson A, Elkashef A. Safety of atomoxetine in combination with intravenous cocaine in cocaine-experienced participants. J Addict Med. 2012 Dec;6(4):265-73. doi: 10.1097/ADM.0b013e31826b767f.
Clinical trial NCT01372865: A Clinical Trial About Treatment of Mild to Moderate Persistent Alergic Rhinnitis With Test or Reference Mometasone (PUMA)
Official title: A Phase III, Non-inferiority, Open-label, Multicenter and Randomized Clinical Trial About the Treatment of Mild to Moderate Persistent Allergic Rhinitis With Eurofarma Mometasone or Reference Mometasone.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mild to Moderate Persistent Allergic Rhinitis
Lead sponsor: Eurofarma Laboratorios S.A.
Sponsor class: INDUSTRY
First posted: 2011-06-14
Enrollment: 364
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective will be to compare the impact of the study formulations on alergic rhinitis carriers.


Eligibility criteria: Inclusion Criteria:

* Sign and date the informed consent form or, in case of subjects younger than 18 years, the document must also be signed by a legal guardian;
* ≥ 12 years old;
* Suffer from mild to moderated persistent alergic rhinitis;
* Total NIS scale score ≥ 4 points at the screening visit and within at least 4 of the 7 days before the randomization visit;
* Indication for use nasal corticosteroid;
* Present with alergic rhinitis symptoms for at least 2 years;
* May undergo a washout period of at least 2 weeks

Exclusion Criteria:

* Patients with severe alergic rhinitis;
* Patients with severe co-morbidities (at the investigator's criteria);
* Patients with mild to severe persistent asthma;
* Clinical history of infection of the airways 30 days before the study entry;
* Patients with structural changes causing nasal obstruction, such as pronounced nasal septum deviation, nasal polyps or any other type of nasal malformation;
* For female subjects, be pregnant or breastfeeding or planning to become pregnant or unwilling to use safe birth control methods during the study;
* subjects in need of other drugs to treat alergic rhinitis, such as anti-immunoglobulin E, immunotherapy, anti-leukotrienes, oral corticosteroids, inhalant corticosteroids, or any administration route other than cutaneous;
* Active smokers (use of cigarette, pipe, cigar or any other form of tobacco in any amount within the past 3 months before the study entry);
* Participation in another clinical study within the past 12 months;

Primary outcomes:
measure: Nasal Index Score (NIS) scale that evaluates nasal obstruction, coryza, and sneezing
timeFrame: 04 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
Study officials:
References:
citation: Antila MA, Castro FM, Sano F, Machado A, Fernandes F, Rosario Filho NA, Stelmach R. Mometasone furoate in the treatment of mild, moderate, or severe persistent allergic rhinitis: a non-inferiority study (PUMA). Braz J Otorhinolaryngol. 2016 Sep-Oct;82(5):580-8. doi: 10.1016/j.bjorl.2015.11.009. Epub 2016 Feb 15.
Clinical trial NCT05093465: A Comparison of Two Behavioral Sleep Interventions Among College Students (ProjectTECH)
Official title: A Comparison Trial of Two Behavioral Sleep Interventions to Improve Sleep-related Outcomes and Reduce Technology Usage Among College Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Sleep Hygiene
Lead sponsor: Oakland University
Sponsor class: OTHER
Collaborators: name: Florida State University
First posted: 2021-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was a randomized controlled trial designed to examine whether augmenting traditional sleep hygiene and stimulus control procedures with technology use reduction stimulus control procedures would produce better sleep and technology usage outcomes.

Detailed description: Sixty college students were randomized to a 4-week sleep hygiene and stimulus control intervention (ACI) or an enhanced intervention including technology stimulus control instructions (TI).

Eligibility criteria: Inclusion Criteria:

* Participants must be at least 18 years old, enrolled at Oakland University, and reside in an on-campus dormitory to participate.

Exclusion Criteria:

* None

Primary outcomes:
measure: Sleep Quality
timeFrame: From baseline to posttest, approximately 5 weeks
measure: Technology Usage
timeFrame: From baseline to posttest, approximately 5 weeks
Secondary outcomes:
measure: Sleep Hygiene
timeFrame: From baseline to posttest, approximately 5 weeks
measure: Sleep Control
timeFrame: From baseline to posttest, approximately 5 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Oakland University
state: Michigan
Study officials:
affiliation: Oakland University
name: Andrea T Kozak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06433765: A Study Evaluating the Effect of BRIUMVI® (Ublituximab) on Pregnancy and Infant Outcomes in Participants With Multiple Sclerosis (MS)
Official title: BRIUMVI® Pregnancy Registry: A Prospective Study of Pregnancy and Infant Outcomes in Patients Treated With BRIUMVI®
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Multiple Sclerosis
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-30
Enrollment: 728
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include pregnant participants with MS who are either exposed or not exposed to BRIUMVI®.

Brief summary: The primary objective of the study is to compare the prevalence rate of major congenital malformations (MCM) between 2 cohorts of pregnant participants with MS who are exposed to BRIUMVI® and who are unexposed to BRIUMVI®.


Eligibility criteria: Inclusion Criteria:

1. For exposed cohort: Participant exposed to at least 1 dose of BRIUMVI®.
2. For unexposed cohort: Participants not exposed to BRIUMVI® at any time during the pregnancy.
3. Diagnosis of MS.
4. Currently or recently (within 1 year of pregnancy outcome) pregnant.
5. Authorization from healthcare provider to provide data to registry.

Exclusion Criteria:

1. Prior to enrollment, participant has exposure to anti-CD20 monoclonal antibodies at any time during pregnancy.
2. Occurrence of pregnancy outcome prior to first contact with the virtual research coordination center (VRCC) (retrospectively enrolled).
3. Exposure to known teratogens and/or investigational medications during pregnancy.

Primary outcomes:
measure: Percentage of Participants with Major Congenital Malformations (MCMs)
timeFrame: Up to 52 weeks post-delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: BRIUMVI® Pregnancy Registry Virtual Research Coordination Center
state: North Carolina
Study officials:
References:
Clinical trial NCT00139165: Long-Term Treatment of Collagenous Colitis With Budesonide
Official title: Long-Term Treatment of Collagenous Colitis With Budesonide. Prospective, Doubleblind Placebo-Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Collagenous Colitis
Keywords: Collagenous colitis
Budesonide treatment
Diarrhea
Lead sponsor: Bonderup, Ole K., M.D.
Sponsor class: INDIV
Collaborators: name: AstraZeneca
First posted: 2005-08-31
Enrollment: 36
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: The aim of the trial is to examine the effect of budesonide treatment on collagenous colitis. All patients is treated for 6 weeks with budesonide and thereafter randomised to 24 weeks treatment with placebo or continued budesonide. The end poit is effect on clinical symptoms (number of daily stools)


Eligibility criteria: Inclusion Criteria:

* Histological criteria of Collagenous colitis
* Clinical activity (\> 3 stools/day)

Exclusion Criteria:

* Treatment of Collagenous colitis within the last 3 months

Primary outcomes:
measure: Clinical symptoms
Secondary outcomes:
measure: Histological changes
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Dept. of medical gastroenterology
city: Aarhus
country: Denmark
facility: Dept. of medical gastroenterology
Study officials:
name: Ole K Bonderup, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01478165: Comparison of TIVA (Total Intravenous Anesthesia) and TIVA Plus Palonosetron in Preventing Postoperative Nausea and Vomiting
Official title: Comparative Study of TIVA(Total Intravenous Anesthesia) and TIVA Plus Palonosetron in Preventing PONV(Postoperative Nausea and Vomiting)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Keywords: Palonosetron
PONV(postoperative nausea and vomiting)
TIVA(Total intravenous anesthesia)
Lead sponsor: Incheon St.Mary's Hospital
Sponsor class: OTHER
First posted: 2011-11-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A total intravenous anesthesia (TIVA) is a useful anesthetic technique that reduces the incidence of postoperative nausea and vomiting (PONV).

Investigator hypothesized the incidence of PONV can be further reduced when palonosetron is added to TIVA.


Eligibility criteria: Inclusion Criteria:

* ASA Physical Status 1 or 2
* Elective gynaecological laparoscopic surgery of ≥ 1h duration

Exclusion Criteria:

* Anti-emetics, steroids, or psychoactive medications within 24 h of study initiation
* Vomiting or retching in the 24 h preceding surgery
* Cancer chemotherapy within 4 weeks or emetogenic radiotherapy within 8 weeks before study entry
* Ongoing vomiting from gastrointestinal disease

Primary outcomes:
measure: Incidence of postoperative nausea and vomiting
timeFrame: For 24 hours after surgery
Secondary outcomes:
measure: Severity of nausea
timeFrame: For 24 hours after surgery
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Incheon St. Mary's hospital
Study officials:
affiliation: Incheon St.Mary's Hospital
name: Soo Kyoung Park
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01600365: Evaluate the Use of Ganciclovir Gel 0.3% for the Treatment of Conjunctivitis Caused by Adenovirus
Official title: "Prospective, Interventional, Randomized, Double-masked With the Use of Ganciclovir Gel 0.3% for Treatment of Conjunctivitis Caused by Adenovirus."
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Conjunctivitis
Adenovirus.
Keywords: Conjunctivitis
adenovirus.
Lead sponsor: Adapt Produtos Oftalmológicos Ltda.
Sponsor class: INDUSTRY
First posted: 2012-05-17
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study the use of ganciclovir gel 0.3% for treatment of conjunctivitis caused by adenovirus.

Detailed description: To evaluate the efficacy and tolerability of ganciclovir ophthalmic gel for the treatment of conjunctivitis comparing to placebo (ophthalmic gel). Visual acuity test and slit lamp examination (biomicroscopy) will be performed at each visit to assess the signs/symptoms and the regression of the disease.

Eligibility criteria: Inclusion Criteria:

* Patients with eye disease with a clinical diagnosis of adenovirus conjunctivitis.
* Patients of both gender aged over 18 years.
* Patients who are not pregnant or nursing.
* Patients able (legally and mentally) to understand and sign informed consent had been signed.

Exclusion Criteria:

* Patients who are in the presence of corticosteroids, either by topical ocular, periocular, intraocular or systemic, for less than 30 days of enrollment and who can not make a drug suspension.
* Patients with serious systemic diseases like AIDS, cancer, etc., which in the opinion of the investigator, may put the patient at risk.
* Patient with a single eye or vision in one eye.

Primary outcomes:
measure: time to regression of the ocular symptomatology
timeFrame: 10 days
Secondary outcomes:
measure: Development of sub-epithelial infiltrates
timeFrame: 10 days
measure: Degree of Bulbar conjunctival Injection
timeFrame: 10 days
measure: Involvement of the second eye
timeFrame: 10 days
measure: Patient Dairy - intensity of ocular pain
timeFrame: 10 days
Other outcomes:
Locations:
Study officials:
affiliation: Federal University of São Paulo
name: Rubens Belfort, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04850365: Abdominal Sacral Hysteropexy Versus Vaginal Sacrospinous Hysteropexy
Official title: Comparison Between Abdominal Sacral Hysteropexy and Vaginal Sacrospinous Hysteropexy for Management of Women With Apical Uterine Descent : a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-04-20
Enrollment: 70
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the current study is to compare abdominal sacral cervicopexy with vaginal sacrospinous cervicopexy in women with apical prolapse in terms of operative time, procedures safety and efficacy.

Detailed description: According to Cochrane group trials , abdominal approaches centered on sacral colpopexy is associated with lower risk of awareness of prolapse, repeat surgery for prolapse and dyspareunia than a variety of vaginal interventions. However, these trials weren't statistically significant and have focused on the effects in terms of anatomy and lacked the effect on functional outcomes, the quality of life, perioperative complications and the operative duration.

In this study, We hypothesize that prolonged operative duration will be associated with a greater risk of developing complications and so may guide us to a minimally invasive approach with better functional outcomes.

Eligibility criteria: Inclusion Criteria:

* In order to be eligible to participate in this study, a subject must meet all of the following criteria:

  1. Symptomatic apical descent stage II or more.
  2. Eligible for both surgical procedures
  3. No uterine or cervical pathology.
  4. Able to consent to participate in the trial.

Exclusion Criteria:

1. Women with contraindication to any surgical procedures.
2. Women with previous apical prolapse surgery.
3. One of the two surgical approaches is not feasible.
4. Women with concomitant surgical procedures apart from correction of the prolapse.
5. Women who prefer to have hysterectomy.

Primary outcomes:
measure: Operative time
timeFrame: intraoperative
Secondary outcomes:
measure: a_clinical effectiveness assessed by the pelvic organ prolapse quantification system (POP_Q).
timeFrame: From 6 months to 1 year follow up
measure: b_Number of participants with treatment_related adverse events as assessed by CTCAE v4.0
timeFrame: From 6 months to 1 year follow up
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams university
Study officials:
affiliation: Ain Shams University
name: Asmaa Ragab Mady
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01823965: Intravitreal Injections of Ranibizumab With Deferred Laser Grid Laser Photocoagulation for Treatment of Diabetic Macular Edema With Visual Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Macular Edema
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In the prospective monocentric open label trial patients with diabetic macular edema will be treated with intravitreal injections of ranibizumab given for 3 months then with laser grid at month 4. During follow-up a ranibizumab injection will be performed every 2 months in case of best-corrected visual acuity decreased more than 5 letters.


Eligibility criteria: Inclusion Criteria:

* diabetes mellitus (1 or2)
* decreased vision from Diabetic Macular Edema (study eye Best Corrected Visual Acuity\<69 letters using E.T.D.R.S testing)
* macular edema

Exclusion Criteria:

* history of severe cardiac disease
* stroke within 12 months
* intraocular inflammation

Primary outcomes:
measure: Number of intravitreal injections of ranibizumab
timeFrame: 1 years
Secondary outcomes:
measure: best-corrected visual acuity
timeFrame: 1 years
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Chu de Poitiers
Study officials:
References: