louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01680458: Diflucan Research For Infant Evaluation Of Antifungal Treatment And Prophylaxis Medication
Official title: Special Investigation Of Fluconazole For Pediatric Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Deep Mycosis
Keywords: antifungal treatment
prophylaxis
administration
Japanese
infants
fluconazole
Diflucan
Regulatory Post Marketing Commitment Plan.
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-09-07
Enrollment: 30
Sex: ALL
Minimum age (years): 0
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients whom an investigator involving A0561022 prescribes the fluconazole (Diflucan).

Brief summary: To collect the efficacy and safety information of fluconazole on infant subjects related to their appropriate use in daily practice.


Eligibility criteria: Inclusion Criteria:

* Male or Female under age of seven patients who are prescribed fluconazole (Diflucan) for antifungal treatment or prophylaxis administration.

Exclusion Criteria:

* Subject of seven years or more who have been prescribed fluconazole.

Primary outcomes:
measure: Number of Participants With Treatment-Related Adverse Events
timeFrame: MAX 13 Weeks
measure: Number of Participants With Treatment-Related Serious Adverse Events
timeFrame: MAX 13 Weeks
measure: Number of Participants With Treatment-Related Adverse Events Unexpected From Japanese Package Insert
timeFrame: MAX 13 Weeks
Secondary outcomes:
measure: Clinical Efficacy Rate
timeFrame: MAX 13 Weeks
measure: Fungi Eradication Rate
timeFrame: MAX 13 Weeks
measure: Onset Rate of Deep Mycosis
timeFrame: MAX 13 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03400358: Uterocervical Angle in the Pregnancy Termination of Multiparous Women
Official title: Uterocervical Angle in the Termination of Second Trimester Pregnancy in Multiparous Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medical; Abortion, Fetus
Second Trimester Abortion
Keywords: uterocervical angle
multiparous
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 148
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiparous pregnant women undergoing medical abortion in the second trimester

Brief summary: To evaluate the uterocervical angle (UCA) in the prediction of second trimester termination success of multiparous women.

Detailed description: Medical termination of pregnancy is a common procedure in obstetrics. In recent years, uterocervical angle (UCA) emerged as a new ultrasound parameter in the prediction of labor. Dziadosz et al concluded that the performance of UCA was even better than the cervical length in their cohort. A wide UCA during second trimester shown to have an increased risk of preterm labor and narrow angle was less likely to have labor.

The investigators are aimed to investigate predictive role of both cervical length and UCA in the termination of second trimester pregnancy.The investigators focused on multiparous women who are taking Foley baloon for the cervical preparation and aim to measure their UCA.

Eligibility criteria: Inclusion Criteria:

* multiparous singleton pregnancy
* no previous systemic illnesses

Exclusion Criteria:

* abnormal Pap smear
* history of dilatation and curettage (D\&C)
* history of LEEP and cervical conization

Primary outcomes:
measure: uterocervical angle
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni SSTRH
Study officials:
References:
Clinical trial NCT03337958: Education With Inhalers in Patients With COPD Exacerbation
Official title: Evaluation of an Educational Intervention in the Management of Inhalers With Tablet and Ventilatory Reeducation: a Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Education
Dry Powder Inhalers
Metered Dose Inhalers
Pulmonary Disease
Chronic Obstructive
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2017-11-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized clinical trial.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Chronic obstructive pulmonary disease (COPD) is a public health problem with great morbidity. The main therapeutic strategy is inhalers. The objective of this study is to determine the efficacy of an educational intervention in the use of inhalers in patients with COPD including ventilatory re-education and video recordings of the patients themselves.

Detailed description: The importance of this pathology lies not only in its high prevalence, which is expected to increase due to the aging of society but also in its high mortality. In Europe, it is estimated that 50% of adult patients do not use the inhaler correctly. The clinical development of COPD includes periods of stability interspersed with symptomatic exacerbations, which usually involve hospitalization. During these hospitalizations, respiratory symptoms are worsening.Nevertheless, in Europe, it is estimated that 50% of adult patients do not use the inhaler correctly. Thus, it is very important the pharmacological education in this patients.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria were to be clinically diagnosed of exacerbation of COPD, to possess pharmacological treatment in the form of inhalers.

Exclusion Criteria:

* Exclusion criteria were inability to provide informed consent, presence of psychiatric or cognitive disorders, neurological disorders, organ failure, cancer or inability to cooperate. Patients who had experienced an exacerbation of prior COPD in less than one month were excluded.

Primary outcomes:
measure: Respiratory parameters
timeFrame: baseline, 12 months
Secondary outcomes:
measure: Knowledge of the disease
timeFrame: Baseline, 12 months
measure: Cognitive Level
timeFrame: Baseline
measure: Functional independence
timeFrame: Baseline
measure: Anxiety-depression level
timeFrame: Baseline
measure: Adhesion to inhalers
timeFrame: Baseline
measure: Dyspnea level
timeFrame: baseline, 12 months
measure: Physical fitness
timeFrame: baseline, 12 months
measure: Technique of the inhaler
timeFrame: baseline, 12 months
measure: Respiratory parameters
timeFrame: baseline, 12 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Department of Physical Therapy
Study officials:
affiliation: Universidad de Granada
name: Marie Carmen Valenza, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06240858: Clinical Study of Self-gripping Mesh in TAPP Versus Lichtenstein Hernia Repair
Official title: Clinical Study of Self-gripping Mesh in Transabdominal Preperitoneal (TAPP) Versus Lichtenstein Hernia Repair
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inguinal Hernia
Keywords: Self-gripping mesh
Laparoscopy
Herniorrhaphy
Lead sponsor: Second Hospital of Jilin University
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 130
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this prospective study is to compare the clinical efficacy of self-gripping mesh in laparoscopic transabdominal preperitoneal versus Lichtenstein hernia repair, in order to improve the outcome of inguinal hernia treatment. The main question it aims to answer is, in which procedure is the self-gripping mesh more effective.

Participants will be divided into the TAPP group and the Lichtenstein group by random number table method, the TAPP group underwent laparoscopic transperitoneal preperitoneal hernia repair, and the Lichtenstein group underwent Lichtenstein hernia repair, both groups used self-gripping meshes.

Researchers will compare the operation time, postoperative time out of bed, postoperative hospital stay, hospital costs and postoperative complications between the two groups to see the clinical efficacy of self-gripping mesh in laparoscopic transabdominal preperitoneal versus Lichtenstein hernia repair.


Eligibility criteria: Inclusion Criteria:

* Male patients aged 18 years and older.
* Patients with a definite diagnosis of unilateral primary inguinal hernia.
* Patients and their families were informed about the study protocol and agreed to participate in the study.

Exclusion Criteria:

* Patients with femoral, recurrent, bilateral, incarcerated and strangulated hernias.
* Patients with previous history of lower abdominal surgery.
* Patients with contraindications to anaesthesia.
* Patients with contraindications to laparoscopic surgery.
* Failure to follow up patients as scheduled.
* Patients with abdominal infections.
* Those who cannot tolerate general anaesthesia surgery due to serious coagulation disorders, cardiopulmonary disorders, etc.

Primary outcomes:
measure: Incidence of moderate to severe pain at 3 and 6 months after surgery.
timeFrame: 3 and 6 months after surgery.
Secondary outcomes:
measure: Incidence of recurrent inguinal hernia at 3 and 6 months after surgery.
timeFrame: 3 and 6 months after surgery.
Other outcomes:
Locations:
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
Study officials:
References:
Clinical trial NCT04757558: C-MAC Video-stylet for Double- Lumen Tracheal Intubation
Official title: C-MAC Video-stylet for Double- Lumen Tracheal Intubation: a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Single Lung Ventilation
Thoracic Anesthesia
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-02-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: C-MAC Video Stylet secures the airway. It is a completely new type of video endoscope, it combines the advantages of both rigid and flexible intubation endoscopes. Video allows everyone involved in the intubation to visualize the anatomy simultaneously which facilitates communication and teamwork.

Detailed description: It can be connected easily to the same C- MAC monitor and Pocket Monitor without requiring any additional light source and camera. Video allows everyone involved in the intubation to visualize the anatomy simultaneously which facilitates communication and teamwork. The device has no lumens so it's very easy to clean. Basically if you can get a tube between the cheek and teeth you can intubate the patient.

Eligibility criteria: Inclusion Criteria:

* aged 18-60 years,
* of both sex
* of American Society of Anesthesiologists (ASA) physical Status II and III
* undergoing elective intra-thoracic surgeries requiring double lumen intubation. BMI -\< 35 kg/m2,
* with Mallampati score of 1 or 2

Exclusion Criteria:

* Mallampati score \> =3;
* inter-incisor distance \< 3 cm;
* thyromental distance \< 6 cm;
* neck extension \< 80°from neck flexion;
* cervical spine instability;
* history of difficult endotracheal intubation
* r difficult mask ventilation; - severe pulmonary ventilation dysfunction
* risk of pulmonary aspiration.

Primary outcomes:
measure: the time taken for intubation (TTI) by C-MAC-VS
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: rehab Abd Elaziz
Study officials:
affiliation: Alexandria University
name: rehab A. Abd Elaziz, Ass.Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01020058: Randomized Study of Open Mesh Repair in Local Anesthesia Versus Cost-optimized Laparoscopic Repair for Inguinal Hernia
Official title: Randomized Controlled Trial Comparing Open Mesh Repair in Local Anesthesia to Cost-Optimized Laparoscopic Repair for Primary Inguinal Hernia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hernia, Inguinal
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
Collaborators: name: Uppsala County Council, Sweden
First posted: 2009-11-25
Enrollment: 384
Sex: MALE
Minimum age (years): 20
Maximum age (years): 80
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 compare the frequency of long-term post operative pain after an open mesh repair ad modum Lichtenstein performed in local anaesthesia to that after an totally extraperitoneal laparoscopic repair (TEP) for primary inguinal hernia. The investigators will also be assessing the cost for the procedures and hospital care as well as the cost for sick-leave depending on procedure performed. The study hypothesis is that the laparoscopic approach will be associated with less long term post operative pain.


Eligibility criteria: Inclusion Criteria:

* Unilateral inguinal hernia
* suitable for open mesh repair in local anesthesia as well as laparoscopic repair
* ASA score I-III
* informed consent

Exclusion Criteria:

* ASA score IV (not suitable for TEP)
* bilateral hernias (laparoscopic repair preferable)
* recurrent hernia (primary repair affects preferable treatment)
* large scrotal hernias (not suitable for local anesthesia)
* earlier open lower abdominal surgery, aside from appendectomy (scarring may be a hindrance for TEP)

Primary outcomes:
measure: long-term post operative pain
timeFrame: 6 wks, 1 year
Secondary outcomes:
measure: cost-effectiveness of the separate procedures
timeFrame: 6wks, 1year
Other outcomes:
Locations:
city: Enkoping
country: Sweden
facility: Enköping Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
Study officials:
affiliation: Uppsala University Hospital
name: Staffan Wollert, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Westin L, Wollert S, Ljungdahl M, Sandblom G, Gunnarsson U, Dahlstrand U. Less Pain 1 Year After Total Extra-peritoneal Repair Compared With Lichtenstein Using Local Anesthesia: Data From a Randomized Controlled Clinical Trial. Ann Surg. 2016 Feb;263(2):240-3. doi: 10.1097/SLA.0000000000001289.
citation: Dahlstrand U, Sandblom G, Ljungdahl M, Wollert S, Gunnarsson U. TEP under general anesthesia is superior to Lichtenstein under local anesthesia in terms of pain 6 weeks after surgery: results from a randomized clinical trial. Surg Endosc. 2013 Oct;27(10):3632-8. doi: 10.1007/s00464-013-2936-1. Epub 2013 Apr 10.
Clinical trial NCT00826358: Comparison of the Bioavailability of Fenofibric Acid and Rosuvastatin From 5/45 mg Strength of ABT-143 Relative to That From the Coadministration of ABT-335 (Fenofibric Acid) 45 mg and Rosuvastatin Calcium 5 mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Adverse events
Pharmacokinetic
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-01-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and compare the pharmacokinetic parameters from the fixed dose combination ABT-143 relative to that from the co-administration of the two monotherapies.


Eligibility criteria: Inclusion Criteria:

1. A condition of general good health
2. BMI 19 to 29

Exclusion Criteria:

1. Currently enrolled in another clinical study
2. Females who are pregnant or breast-feeding

Primary outcomes:
measure: To determine the safety and tolerability of ABT-143 (vs. ABT-335 + rosuvastatin) in healthy adults.
timeFrame: 7 days
measure: To determine the pharmacokinetic profile for ABT-143 (vs. ABT-335 + rosuvastatin) in healthy adults.
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 13441
state: Florida
Study officials:
affiliation: AstraZeneca
name: Torbjörn Lundström, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03638596: Leveraging Transdermal Alcohol Monitoring to Reduce Drinking Among DWI Defendants
Official title: Leveraging Transdermal Alcohol Monitoring to Reduce Drinking Among DWI Defendants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drunk Driving
Keywords: Alcohol Impaired Driving
Driving While Intoxicated
Driving Under the Influence
Driving While Impaired
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2018-08-20
Enrollment: 158
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: random assignment to treatment and control arms
Primary purpose: TREATMENT

Brief summary: The current study will evaluate the efficacy of contingency management (i.e., reinforcement for avoiding heavy drinking) among adults arrested for drunk driving and who are at risk for ongoing heavy drinking.

Detailed description: Individuals who have a drunk driving arrest and are at risk for ongoing heavy drinking will be recruited to test the efficacy of contingency management for reducing alcohol use and identifying mechanisms of change. We will recruit those arrested for drunk driving offenses, ≥ 21 years of age, who at risk for ongoing heavy alcohol use and randomize them to one of two groups: control or a contingency management. Participants experience 8 weekly assessments of current alcohol use and other variables associated with changes in alcohol use. Post-intervention, participants will return to the laboratory once per month at 3, 6, 9, and 12 months post-study entry for follow-up procedures to determine the mechanisms of drinking behavior change.

Eligibility criteria: Inclusion Criteria:

* arrested for drunk driving offense

Exclusion Criteria:

* significant alcohol withdrawal symptoms
* medical condition that would contraindicate participation (e.g., pregnancy, scheduled surgery)
* inability to comprehend the informed consent process or study instructions
* presence of a DSM-5 psychiatric disorder with symptoms of psychosis and/or delirium
* incarceration

Primary outcomes:
measure: Percent heavy drinking days
timeFrame: 8-weeks
Secondary outcomes:
measure: Percent drinking days
timeFrame: 8-weeks
measure: Follow-up percent heavy drinking days
timeFrame: 12-months
measure: Follow-up percent drinking days
timeFrame: 12-months
measure: Measurement of alcohol biomarker
timeFrame: Baseline to 8-weeks
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center San Antonio
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center San Antonio
name: Nathalie Hill-Kapturczak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06891196: Mixed-Methods Evaluation of Short-, Medium-, and Long-Term Outcomes Following Hip Treatment
Official title: Mixed-Methods Evaluation of Short-, Medium-, and Long-Term Outcomes Following Hip Treatment
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hip Dysplasia
Legg-Calvâe-Perthes Disease
Avascular Necrosis of Hip
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over the age of 18 seen for a concern of hip pathology at Mayo between 1975 and 2024.

Brief summary: This study, titled "Mixed-Methods Evaluation of Short-, Medium-, and Long-Term Outcomes Following Hip Treatment," aims to assess the long-term effectiveness of treatments for pediatric hip conditions, including hip dysplasia, Legg-Calve-Perthes disease, SCFE, and avascular necrosis.

Detailed description: Conducted at Mayo Clinic, the study combines retrospective chart reviews and prospective follow-up to gather data on clinical outcomes, radiographic measures, and patient-reported outcomes (PROs) like functional status, pain, and quality of life.

The retrospective component analyzes records from 1975 to 2024, while the prospective component includes follow-up surveys using validated PRO measures (e.g., HOOS, SF-12, VAS). This study seeks to identify recurrence rates and complications associated with hip treatments, providing insights to improve future care standards for pediatric hip conditions. Data will be securely stored, with confidentiality maintained throughout.

Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18 seen for a concern of hip pathology at Mayo between 1975 and 2024
* Patients over 18 who can be contacted for follow-up and are willing to participate.

Exclusion Criteria:

* Patients presenting over age 18 for hip dysplasia
* Patients who are unwilling to complete follow up surveys.

Primary outcomes:
measure: Revision surgery
timeFrame: 2 years
Secondary outcomes:
measure: Change in neck-shaft angle measurement
timeFrame: Baseline, 2 years
measure: Change in acetabular index
timeFrame: Baseline, 2 years
measure: Change in migration index
timeFrame: Baseline, 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Emmanouil Grigoriou, M.D.
role: PRINCIPAL_INVESTIGATOR
References: