louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00002175: Epicutaneous 1-Chloro-2, 4-Dinitrobenzene (DNCB) Patch in HIV Infection.
Official title: Epicutaneous 1-Chloro-2, 4-Dinitrobenzene (DNCB) Patch in HIV Infection.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: Cohort Studies
RNA, Viral
Administration, Cutaneous
Anti-HIV Agents
Dinitrobenzenes
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of dinitrochlorobenzene (DNCB) in patients with early HIV infection by monitoring immunologic parameters and serum HIV RNA. To facilitate the understanding of possible alterations in the immunological status of the HIV+ patient cohort.


Eligibility criteria: Inclusion Criteria

Patients must have:

* EITHER HIV negative or documented HIV+ by both the ELISA and Western blot tests.

For HIV+ patients:

* Patients must fail to meet the AIDS-defining criteria.
* CD4 lymphocyte count between 200 - 500 cells/mm3.

Exclusion Criteria

Co-existing Condition:

Excluded:

Patients with obvious ultra violet(UV)-irradiated skin damage in the treatment sites.

Concurrent Medication:

Excluded:

* Patients who are likely to commence antiretrovirals within the 6-month study period.
* Patients using other immunomodulator therapies or other alternative therapies.
* Patients likely to require chemotherapy during the course of the study.

Concurrent Treatment:

Excluded:

* Patients who are likely to require significant UV light exposure during the study period.
* Patients who are likely to require radiation therapy during the course of the study.

Prior Medication:

Excluded:

* Prior exposure to DNCB.
* Patients who have used antiretroviral medications within the previous 3 months.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Queen Emma Clinics / The Queen's Med Ctr
state: Hawaii
Study officials:
References:
Clinical trial NCT00978575: Iron Substitution After Upper Gastro-Intestinal Bleeding
Official title: Comparison of the Efficacy of Compliant Oral Iron Treatment (FerroDuretter ®) for 3 Months After Discharge Versus Single-dose of Intravenous Iron (Ferinject ®) Before Discharge in Patients With Acute Bleeding From Upper Gastrointestinal Tract. A Double Blinded Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastrointestinal Hemorrhage
Anemia
Keywords: Iron treatment
Upper gastrointestinal bleeding
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: GCP-unit at Aarhus University Hospital, Aarhus, Denmark
name: Vifor Pharma
First posted: 2009-09-17
Enrollment: 97
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 trial is a double-blind randomized trial designed to examine whether compliant iron therapy (intravenous or oral) for 3 months after discharge increases hemoglobin levels more and faster than no treatment - in patients with acute bleeding from upper gastrointestinal tract. The trial will include 126 patients at Aarhus University Hospital. In addition to efficacy assessment quality of life assessment and health economic calculations between the treatments will be compared.


Eligibility criteria: Inclusion Criteria:

* Acute upper gastrointestinal bleeding
* Anemia

Exclusion Criteria:

* Liver disease
* Terminal cancer
* Kidney disease
* variceal bleeding
* Pregnancy

Primary outcomes:
measure: haemoglobin
timeFrame: 13 weeks
Secondary outcomes:
measure: Quality of life Health economics
timeFrame: 13 weeks, 6 and 12 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: Aarhus University Hospital
name: Hendrik Vilstrup, Professor
role: STUDY_CHAIR
References:
citation: Bager P, Dahlerup JF. Randomised clinical trial: oral vs. intravenous iron after upper gastrointestinal haemorrhage--a placebo-controlled study. Aliment Pharmacol Ther. 2014 Jan;39(2):176-87. doi: 10.1111/apt.12556. Epub 2013 Nov 19.
Clinical trial NCT06595875: Modified Thoracoabdominal Nerve Block With Perichondrial Approach in Laparoscopic Cholecystectomy Surgery
Official title: Modified Thoracoabdominal Nerve Block With Perichondrial Approach in Laparoscopic Cholecystectomy Surgery: A Prospective, Randomized, Controlled, Double-Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Lead sponsor: Konya City Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 60
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: PREVENTION

Brief summary: Our primary objective is to evaluate the postoperative numerical rating scale scores in patients undergoing laparoscopic cholecystectomy with an m-TAPA block. Our secondary objectives are to assess the total amount of rescue analgesia consumed, the time to first rescue analgesia, patient satisfaction, and the occurrence of complications.

Detailed description: Patients aged 18-65 with American Society of Anesthesiologists physical status I-III, undergoing laparoscopic cholecystectomy under general anesthesia, were included in the study. Patients with contraindications to regional anesthesia, impaired consciousness, coagulopathy, those using anticoagulants, those with infection at the procedure site, those with allergies to local anesthetics, pregnant women, and emergency cases were excluded from the study.

The primary outcome measures were the numerical rating scale pain scores (0-10, 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain) at 0, 2, 4, 8, 12, and 24 hours postoperatively. The secondary outcome measures included the total amount of rescue analgesic consumed, the time to first rescue analgesia, the occurrence of complications (such as infection, hematoma formation, and local anesthetic systemic toxicity), and patient satisfaction. The age, gender, weight, height, surgery duration of patients in both groups were recorded. A Likert scale (1 = not satisfied at all, 2 = not satisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied) was used to assess patient satisfaction.

Eligibility criteria: Inclusion Criteria:

* 18-65 years
* American Society of Anesthesiologists physical status I-III
* Laparoscopic cholecystectomy under general anesthesia

Exclusion Criteria:

* Patients with contraindications to regional anesthesia
* Impaired consciousness
* Coagulopathy
* Using anticoagulants
* Infection at the procedure site
* Allergies to local anesthetics
* Pregnant women
* Emergency cases

Primary outcomes:
measure: Postoperative analgesia
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Konya City Hospital
Study officials:
References:
Clinical trial NCT02275975: Drug-Drug Interaction Study in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Adult Volunteers
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to assess the effects of fluconazole on the pharmacokinetics of K 877 in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening.
* Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
* Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges or is showing no clinically relevant deviations, as judged by the investigator at Screening.

Exclusion Criteria:

* Subject has clinically relevant abnormalities in the screening or check in assessments.
* Subject has a blood pressure (as measured at Screening during the collection of vital signs) after resting supine for at least 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic (for males) and 50 mm Hg diastolic (for females).
* Subject has a supine pulse rate (as measured at Screening during collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute.

Primary outcomes:
measure: Maximum concentration (Cmax)
timeFrame: 72 hours
Secondary outcomes:
measure: Area under concentration curve (AUC)
timeFrame: 72 hours
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD
state: Texas
Study officials:
affiliation: Kowa Research Institute, Inc.
name: Stuart Campbell
role: STUDY_DIRECTOR
References:
Clinical trial NCT03265275: Why Still in Hospital After Hip Fracture Surgery?
Official title: Why Still in Hospital After Hip Fracture Surgery?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Fractures
Keywords: Fast track
Lead sponsor: University Hospital, Akershus
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2017-08-29
Enrollment: 182
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years of age, who have been operated for a hip fracture at the orthopedic department, Akershus University Hospital.

Brief summary: At our institution, hip fracture patients are admitted and treated according to a fast track patient pathway. The aim of this study is to identify areas of this patient pathway that can be improved. To achieve this, the study will investigate the underlying reasons for the continued need for hospitalization on the consecutive days after hip fracture surgery.

Detailed description: The study will be conducted at the orthopedic department, Akershus University Hospital, as a prospective observational study and will include approximately 200 consecutive hip fracture patients. The patients will be evaluated once daily for the fulfillment of predefined discharge criteria. If the discharge criteria are not met or if the criteria are met but the patient is not discharged in spite of this the underlying reason(s) are recorded.

Eligibility criteria: Inclusion Criteria:

* Operated at the orthopedic department, Akershus University Hospital, for a hip fracture

Exclusion Criteria:

* Lack of written informed consent

Primary outcomes:
measure: Factors necessitating hospitalization after hip fracture surgery
timeFrame: Recorded using a check-list once daily from first day after hip fracture surgery until discharge from the orthopedic department, typically between 1 to 14 days after hip fracture surgery
Secondary outcomes:
measure: Percentage of patients discharged to their preoperative level of care
timeFrame: At hospital discharge, typically between 1 to 14 days after hip fracture surgery
measure: Length of hospital stay
timeFrame: At hospital discharge, typically between 1 to 14 days after hip fracture surgery
Other outcomes:
Locations:
city: Lørenskog
country: Norway
facility: Akershus University hospital
Study officials:
affiliation: University Hospital, Akershus
name: Asbjorn Aaroen, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02314975: Intermittent Vibrational Force and Orthodontic Tooth Movement
Official title: Intermittent Vibrational Force and Orthodontic Tooth Movement: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Crowding
Vibrational Force
Fixed Orthodontic Appliances
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2014-12-11
Enrollment: 81
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the clinical efficiency of conventional fixed appliance orthodontic treatment with that supplemented by the daily application of cyclic forces to the dentition via a removable (AcceleDent) vibrational appliance. The primary outcome measure is rapidity of tooth alignment; whilst secondary outcome measures include pain and discomfort during treatment, rapidity of orthodontic space closure, changes in arch dimensions and root length.


Eligibility criteria: Inclusion Criteria:

* Subjects will be recruited from a sample of consecutive cases attending for routine fixed appliance orthodontic treatment with conventional pre-adjusted edgewise brackets that satisfy the following criteria: in the permanent dentition; a requirement for extraction of a premolar unit in each quadrant; incisor irregularity between 5-12 mm.

Exclusion Criteria:

* no medical contraindications; no craniofacial anomalies or cleft lip/palate;

Primary outcomes:
measure: Orthodontic tooth movement (incisor alignment)
timeFrame: 2-12 months from start
Secondary outcomes:
measure: Discomfort during initial orthodontic tooth movement
timeFrame: 1 week from start
measure: Orthodontic space closure
timeFrame: 6-30 months from start
measure: Root resorption
timeFrame: 6-12 months from start
Other outcomes:
Locations:
Study officials:
References:
citation: DiBiase AT, Woodhouse NR, Papageorgiou SN, Johnson N, Slipper C, Grant J, Alsaleh M, Khaja Y, Cobourne MT. Effects of supplemental vibrational force on space closure, treatment duration, and occlusal outcome: A multicenter randomized clinical trial. Am J Orthod Dentofacial Orthop. 2018 Apr;153(4):469-480.e4. doi: 10.1016/j.ajodo.2017.10.021.
citation: DiBiase AT, Woodhouse NR, Papageorgiou SN, Johnson N, Slipper C, Grant J, Alsaleh M, Cobourne MT. Effect of supplemental vibrational force on orthodontically induced inflammatory root resorption: A multicenter randomized clinical trial. Am J Orthod Dentofacial Orthop. 2016 Dec;150(6):918-927. doi: 10.1016/j.ajodo.2016.06.025.
citation: Woodhouse NR, DiBiase AT, Johnson N, Slipper C, Grant J, Alsaleh M, Donaldson AN, Cobourne MT. Supplemental vibrational force during orthodontic alignment: a randomized trial. J Dent Res. 2015 May;94(5):682-9. doi: 10.1177/0022034515576195. Epub 2015 Mar 10.
Clinical trial NCT00384475: A Study of Ciclesonide Nasal Spray in Patients 18 Years and Older With Seasonal Allergic Rhinitis (BY9010/M1-413)
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study Using the Environmental Exposure Chamber (EEC) to Assess the Onset of Action of Ciclesonide, Applied as a Nasal Spray (200 mcg, Once Daily), in the Treatment of Seasonal Allergic Rhinitis (SAR) in Patients 18 Years and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Seasonal
Hay Fever
Keywords: Seasonal Allergic Rhinitis
Ciclesonide
Hay Fever
SAR
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-10-06
Enrollment: 500
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 purpose of this study is to investigate the safety and effectiveness of ciclesonide nasal spray as compared with placebo (inactive substance) nasal spray in relieving symptoms of seasonal allergic rhinitis caused by pollen. Ciclesonide will be administered once during the exposure to ragweed pollen in a controlled environment. The study duration consists of a baseline period (up to 5 days) and a treatment period (1 day). The study will provide further data on safety and tolerability of ciclesonide.


Eligibility criteria: Main Inclusion Criteria:

* Written informed consent
* General good health
* History of SAR to short ragweed pollen for 2 years immediately preceding the study
* Demonstrated sensitivity to short ragweed known to induce SAR through a standard skin prick test

Main Exclusion Criteria:

* Clinically significant physical finding of nasal anatomical deformities causing greater than 50% obstruction, including but not limited to nasal polyps, septal defects, respiratory tract malformations, nasal trauma or surgery
* Known hypersensitivity to any corticosteroid
* History of a respiratory infection or disorder including but not limited to bronchitis, pneumonia, chronic sinusitis, influenza or SARS (severe acute respiratory syndrome) within 14 days preceding the Screening Visit
* History of alcohol or drug abuse within 2 years preceding the Screening Visit
* Active asthma requiring treatment of inhaled or systemic corticosteroids and/or routine use of beta-agonists or any controller drugs
* Use of antibiotic therapy for acute conditions within 14 days preceding the Screening Visit
* Exposure to systemic corticosteroids for any indication, chronic or intermittent within 60 days preceding the Screening Visit

Primary outcomes:
measure: Onset of action, measured by change from baseline in Total Nasal Symptom Score.
Secondary outcomes:
measure: changes in symptoms, safety.
Other outcomes:
Locations:
city: Ontario, Mississauga
country: Canada
facility: Altana Pharma/Nycomed
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References:
Clinical trial NCT04363775: Comparison of VieScope vs. Macintosh Laryngoscope for Intubation in Level Cpersonal Protective Equipment Conditions
Official title: Comparison of VieScope Versus Macintosh Laryngoscope for Emergency Intubation Under Level C Personal Protective Equipment Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheal Intubation
Infection
Projection
Keywords: SARS-CoV-2
COVID-19
tracheal intubation
laryngoscope
personal protective equipment
Lead sponsor: Lazarski University
Sponsor class: OTHER
Collaborators: name: Poznan University of Medical Sciences
name: Wroclaw Medical University
name: Medical University of Bialystok
First posted: 2020-04-27
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The current COVID-19 pandemic, this is especially since the transmission of SARS-CoV-2 is thought to occur mainly through respiratory droplets generated by coughing and sneezing, by direct contact with contaminated surfaces and because in a large number of patients COVID-19 disease may be asymptomatic. As recommended by the CDC for aerosol-generating procedures (AGP), medical personnel should be equipped with full personal protective equipment (PPE) for AGP. Therefore, it is reasonable to search for the most effective methods of intubation in those conditions.


Eligibility criteria: Inclusion Criteria:

* paramedic
* consent voluntary participation in the study
* none experience in Vie Scope
* none experience in intubation with personal protective equipment

Exclusion Criteria:

* refusal to participate in the study

Primary outcomes:
measure: time to intubation
timeFrame: 1 day
Secondary outcomes:
measure: success of intubation
timeFrame: 1 day
measure: Number of optimalization maneuvers
timeFrame: 1 day
measure: Procedure Ease of use
timeFrame: 1 day
measure: the degree of visibility of the glottis
timeFrame: 1 day
measure: Cormack - Lehane grade
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Lazarski Univeristy
Study officials:
References:
Clinical trial NCT06230575: Locoregional Blocks for Breast Cancer Surgeries
Official title: Locoregional Blocks for Breast Cancer Surgeries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Analgesia
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Breast surgeries are common operative procedures that require appropriate postoperative analgesia.

Detailed description: Numerous pain relief techniques, including several new regional anesthesia techniques, are available for control of acute pain after breast surgery.

Eligibility criteria: Inclusion Criteria:

* female cancer breast patient
* age from 18- 65

Exclusion Criteria:

* coagulation defect
* Patient refusal
* abnormal kidney and or liver function tests

Primary outcomes:
measure: time to receive first postoperative analgesic
timeFrame: First 24 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Walaa Y Elsabeeny
Study officials:
affiliation: Assistant professor of Anesthesia, Surgical critical care and Pain Management, National Cancer Institute, Cairo University
name: Walaa Y Elsabeeny, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00047775: African-American Heart Failure Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Congestive Heart Failure
Lead sponsor: Nitromed
Sponsor class: INDUSTRY
First posted: 2002-10-21
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A placebo-controlled trial of BiDil added to standard therapy in African-American patients with heart failure.

Detailed description: The overall objective is confirmation of BiDil's Safety and Efficacy in African-American (AFA) Patients with Moderate to Severe Symptomatic Heart Failure.

Eligibility criteria: * African American male or female 18 years or older.
* NYHA Class 3 \& 4.
* Have either a resting LVEF less than or equal to 35% (by any method) or a resting LVIDD greater than 2.9 cm/m2 BSA (or greater than 6.5 cm) with LVEF less than 45% (by echocardiogram).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Cooper Green Hospital
state: Alabama
city: Little Rock
country: United States
facility: Cardiology and Medicine Clinic
state: Arkansas
city: Washington
country: United States
facility: Howard University Hospital
state: District of Columbia
city: Aventura
country: United States
facility: Miami International Cardiology Consultants
state: Florida
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: Minneapolis VA Medical Center
state: Minnesota
city: New York
country: United States
facility: Saint Vincents Hospital and Medical Center
state: New York
Study officials:
affiliation: University of Minnesota
name: Anne L. Taylor, M.D.
role: STUDY_CHAIR
References:
citation: Anand IS, Win S, Rector TS, Cohn JN, Taylor AL. Effect of fixed-dose combination of isosorbide dinitrate and hydralazine on all hospitalizations and on 30-day readmission rates in patients with heart failure: results from the African-American Heart Failure Trial. Circ Heart Fail. 2014 Sep;7(5):759-65. doi: 10.1161/CIRCHEARTFAILURE.114.001360. Epub 2014 Jun 26.
citation: Mitchell JE, Tam SW, Trivedi K, Taylor AL, O'Neal W, Cohn JN, Worcel M. Atrial fibrillation and mortality in African American patients with heart failure: results from the African American Heart Failure Trial (A-HeFT). Am Heart J. 2011 Jul;162(1):154-9. doi: 10.1016/j.ahj.2011.04.022.