louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00095368: APC-111 Once a Day (QD) for 7 Days vs. Penicillin Taken Four Times a Day (QID) for 10 Days in Patients With Strep Throat
Official title: A Phase III, Randomized, Double-Blind, Double-Dummy Multicenter Study to Evaluate the Efficacy and Safety of 775 mg APC-111 MP Tablet QD for 7 Days vs Penicillin VK 250 mg QID for 10 Days in Patients With Streptococcus Pyogenes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pharyngitis
Tonsillitis
Keywords: Pharyngitis
Tonsillitis
Lead sponsor: Advancis Pharmaceutical Corporation
Sponsor class: INDUSTRY
First posted: 2004-11-04
Enrollment: 500
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 purpose of the this study is to evaluate the safety of efficacy of APC-111 775 mg MP tablet once daily dosing for 7 days for treating patients with strep throat. The evaluation will look to confirm if APC-111 eliminates the bacterial infection (Streptococcus pyogenes).


Eligibility criteria: Inclusion Criteria:

* Give informed consent, assent and patient authorization
* Age 12 and over
* A clinical diagnosis of acute pharyngitis or tonsillitis
* A positive rapid Strep test
* Can swallow the oral study dosage forms
* Females must have a negative urine pregnancy test and be using acceptable birth control if sexually active

Exclusion Criteria:

* Chronic or recurrent odynophagia
* Need for hospitalization or IV antimicrobial therapy
* Pharyngitis known or suspected due to a pathogen resistant to beta-lactam antimicrobials
* Known carrier of S. pyogenes
* Allergies to penicillin or other beta-lactam antibiotics
* Any serious illness or concomitant condition that the investigator judges will preclude inclusion to the study
* Seizure disorder
* Pregnant or nursing
* Expectation of additional systemic antibacterials would be required for another condition
* Current drug or alcohol abuse
* Any experimental drug or device within the last 30 days
* Prior systemic antibiotic therapy within the last 30 days
* Hospitalization within the last month which included antibacterial therapy
* The presence of clinically significant hematologic conditions, etc
* Probenecid treatment

Primary outcomes:
measure: Bacteriological outcome at the Test of Cure Visit
Secondary outcomes:
measure: Bacteriological outcome at the Late Post Therapy Visit
measure: Clinical Outcome
measure: Safety
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Manford Gooch, MD
state: Utah
Study officials:
References:
Clinical trial NCT05693168: Accuracy of Pulse Oximeter With Profound Hypoxia
Official title: Accuracy of Pulse Oximeter With Profound Hypoxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia
Lead sponsor: Sibel Health Inc.
Sponsor class: INDUSTRY
First posted: 2023-01-20
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Clinical evaluation of the accuracy of SpO2 measurements with the ANNE Limb Sensor compared to blood gas analysis in healthy, adult subjects. Hypoxia is induced in patients to different and stable levels of SaO2 over the range of 70-100%.


Eligibility criteria: Inclusion Criteria:

* The subject is male or female, between the ages of 18 and 55 years.
* The subject is in good general health with no evidence of any medical problems
* The subject is fluent in both written and spoken English
* The subject has provided informed consent and is willing to comply with the study procedures.

Exclusion Criteria:

* Known history of heart disease, lung disease, kidney or liver disease
* Diagnosis of asthma, sleep apnea, or use of CPAP
* Subject has diabetes
* Subject has a clotting disorder
* The subject has a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation
* The subject has any other serious systemic illness
* Th subject is a current smoker
* Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators would interfere with the sensors working correctly
* The subject has a history of fainting or vasovagal response
* The subject has a history of sensitivity to local anesthesia
* The subject has a diagnosis of Raynaud's disease
* The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test)
* The subject is pregnant, lactating, or trying to get pregnant
* The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures
* The subject has any other condition, which in the opinion of the investigators would make them unsuitable for the study

Primary outcomes:
measure: ARMS of SpO2 Measurements with ANNE Limb compared to SaO2
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Hypoxia Research Laboratory Department of Anesthesia and Perioperative Care University of California, San Francisco
state: California
Study officials:
References:
Clinical trial NCT04987268: CHIP and Residual Cardiovascular Event Tendency After Smoking Cessation
Official title: Clonal Hematopoiesis of Indeterminate Potential and Residual Cardiovascular Event Tendency After Smoking Cessation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ACS
Clonal Hematopoiesis of Indeterminate Potential
Smoking Cessation
Lead sponsor: Shenyang Northern Hospital
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 1029
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ACS patients undergoing complete revascularization

Brief summary: In order to identify the association between clonal hematopoiesis of indeterminate potential (CHIP) and cardiovascular risks after smoking cessation, this study intends to recruit ACS patients undergoing complete revascularization and perform whole-exome sequencing for enrolled patients to identify the prevalence of CHIP mutations. After 1-year follow-up, the relationship of presence of CHIP mutations and the occurrence of MACCEs will be explored, irrespective of smoking cessation or not. CHIP may be a potential risk factor of poor prognosis of ACS.


Eligibility criteria: Inclusion Criteria:

* 1. In-patients with acute coronary syndrome to undergo PCI 2. Complete revascularization during the index hospitalization 3. Written informed consent

Exclusion Criteria:

* 1. Periprocedural complications (coronary artery dissection, perforation, myocardial infarction, stroke, death) 2. Planned coronary revascularization at discharge 3. Patients with severe chronic disease (uremia, liver cirrhosis, COPD (chronic obstructive pulmonary disease) 4. Abnormal blood counts caused by hematological diseases 5. Diagnosed malignancy

Primary outcomes:
measure: prevalence of CHIP mutations
timeFrame: 24 hours
Secondary outcomes:
measure: MACCE
timeFrame: 1 year
Other outcomes:
Locations:
city: Shenyang
country: China
facility: General Hospital of Shenyang Military Region
state: Liaoning
Study officials:
affiliation: The General Hospital of Northern Theater Command
name: Yaling Han, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05325268: Monteggia Fractures: Analysis of Patient Reported Outcome Measurements in Correlation to Ulnar Fracture Localization
Official title: Monteggia Fractures: Analysis of Patient Reported Outcome Measurements in Correlation to Ulnar Fracture Localization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Monteggia's Fracture
Keywords: elbow
fracture
patient reported outcome
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 35
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated at the University Hospital Dresden.

Brief summary: Patients who had suffered a Monteggia fracture (lesion of the elbow) will be assessed regarding clinical and functional outcome (PROM) after treatment with osteosynthesis.

Detailed description: A retrospective, monocentric study will be performed. Patients who underwent surgical treatment after suffering a Monteggia injury or a Monteggia like lesion between 2012 and 2018 will be included. Fractures will classified after Bado and Jupiter, according to the fracture location of the proximal ulna, as well as regarding the potential accompanying ligamentary injury.

In a follow-up examination validated patient-reported outcome measures (Disabilities of Arm, Shoulder and Hand Score \[DASH\], MEPS \[Mayo Elbow Performance Score\], Oxford Elbow Score \[OES\], Pain, Subjective Elbow Score) and functionality (range of motion \[ROM\], posterolateral instability, strength, valgus-/varus-stress) will be evaluated. In addition, treatment strategy and complications will be analysed.

Eligibility criteria: Inclusion Criteria:

* Patients with Monteggia fractures treated with osteosynthesis between 2012 and 2018
* understanding of German language (written and oral)
* informed consent

Exclusion Criteria:

* Patients not meeting the above criteria

Primary outcomes:
measure: Disabilities of Arm, Shoulder and Hand Score (DASH)
timeFrame: Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months
measure: Oxford Elbow Score (OES)
timeFrame: Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months
measure: Mayo Elbow Performance Score (MEPS)
timeFrame: Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months
measure: Range of Motion (ROM)
timeFrame: Time of Follow-Up assesment, approx. 3-7 years after surgery, avg. 50months
Secondary outcomes:
measure: Ulnar fracture localization (Radiologically)
timeFrame: baseline (timepoint of injury)
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus
Study officials:
References:
citation: Tille E, Seidel L, Schlussler A, Beyer F, Kasten P, Bota O, Biewener A, Nowotny J. Monteggia fractures: analysis of patient-reported outcome measurements in correlation with ulnar fracture localization. J Orthop Surg Res. 2022 Jun 7;17(1):303. doi: 10.1186/s13018-022-03195-1.
Clinical trial NCT00439868: A Study To Evaluate The Effect Of WELLBUTRIN XL On Intraocular Pressure
Official title: A Cross-over Study to Evaluate the Effect of WELLBUTRIN XL on Intraocular Pressure in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depressive Disorder
Keywords: WELLBUTRIN XL, intraocular pressure, healthy volunteers
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-02-26
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: This study will be conducted in healthy volunteers to investigate the effect on intraocular pressure of 2 weeks of treatment with 300mg WELLBUTRIN XL/day.


Eligibility criteria: Inclusion Criteria:

* Healthy males or females.
* Non-smokers
* Agree to remain in the clinic for the time defined in the protocol.
* Normal ECG.

Exclusion Criteria:

* Any serious medical disorder or condition.
* Any history of an endocrine disorder.
* Any clinically significant laboratory abnormality.
* History of psychiatric illness.
* Any history of suicidal attempts or behavior.
* Risk factors for precipitation of angle closure glaucoma or elevated IOP.
* Inability to refrain from use of contact lenses during the study days, if correction is required.
* Self-administered Beck Depression Inventory II scale total score greater than 9, and a suicide question score of greater than zero.
* Current or past history of seizure disorder or brain injury (traumatic or disease-related); or any condition which, in the opinion of the investigator, predisposes to seizure - Women having a positive serum HCG pregnancy test at screening, a positive urine pregnancy test before admission to the Unit during the in-house periods, who are not willing to use acceptable methods of contraception or who are lactating or planning to become pregnant within the three months following the screening visit.

Primary outcomes:
measure: Intraocular pressure at Day -1, Days 1 & 14.
timeFrame: at Day -1, Days 1 & 14.
Secondary outcomes:
measure: Intraocular pressure,Pupil diameter, anterior chamber angle
timeFrame: Days-1,1&14
measure: Wellbutrin XL plasma level
timeFrame: Days1,12-14
measure: adverse events
timeFrame: each visit
measure: lab tests,ECG,vital signs:
timeFrame: screening,followup
measure: lab tests:
timeFrame: Days-2,13-14
measure: ECG:
timeFrame: Day 14
measure: vital signs:
timeFrame: Days-2,-1,1,14
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: GSK Investigational Site
state: Florida
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT06759168: Impact of Cataract Surgery on the Incidence and Progression of Dry Eye Disease
Official title: Impact of Cataract Surgery on the Incidence and Progression of Dry Eye Disease
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Dry Eye
Keywords: Dry eye
Cataract surgery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-01-06
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Both males and females above 40- year old going cataract surgery

Brief summary: Relation between dry eye and cataract

Detailed description: Study the impact of cataract surgery on the incidence and progression of dry eye disease

Eligibility criteria: Inclusion Criteria:

* patients aged above 40-years old undergoing cataract surgery
* patients without dry eye disease
* patients with mild to moderate degree of dry eye disease Both gender, male and female

Exclusion Criteria:

* patients aged less 40-year old undergoing cataract surgery
* patients with severe degrees of dry eye disease
* patients with autoimmune disease
* patients with chronic blepharitis

Primary outcomes:
measure: Dry eye after cataract surgery
timeFrame: 1 week, 1 month and 3 months
Secondary outcomes:
measure: risk factors to dry eye
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
citation: Ram J, Gupta A, Brar G, Kaushik S, Gupta A. Outcomes of phacoemulsification in patients with dry eye. J Cataract Refract Surg. 2002 Aug;28(8):1386-9. doi: 10.1016/s0886-3350(02)01387-1.
citation: Shaaban YM, Aziz BF. Tear film assessment before and after phacoemulsification in patients with age-related cataracts. BMC Ophthalmol. 2024 Jul 11;24(1):280. doi: 10.1186/s12886-024-03542-2.
Clinical trial NCT00294268: Cognitive Behavioural Therapy for Obesity
Official title: A Maintenance-Oriented Cognitive Behavioural Therapy in the Treatment of Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: obesity
CBT
motivational enhancement therapy
weight loss maintenance
Lead sponsor: University of Sydney
Sponsor class: OTHER
First posted: 2006-02-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness of a cognitive behavioural treatment (CBT) designed to help obese patients lose weight and to maintain their weight losses over time. It is hypothesized that CBT will result in greater sustained weight loss.

Detailed description: The primary aim of the present study is to improve the maintenance of weight loss, and hence the physical, psychological and social well-being, of obese patients who have sought weight loss treatment. To do so, it will implement a cognitive-behavioural treatment (CBT) with motivational enhancement strategies specifically designed to target weight maintenance. It is hypothesized that the maintenance-oriented CBT approach will result in sustained weight loss, as well as improved physical, psychological and social well-being.

Eligibility criteria: Inclusion Criteria:

* The participants will be recruited from among patients referred to the Metabolism and Obesity Service of Royal Prince Alfred Hospital.
* The inclusion criteria include: 18-65 years of age and a body mass index (BMI: kg/m2) between 30-45.

Exclusion Criteria:

* psychiatric conditions (i.e., current psychosis, severe depression, mental retardation, and drug or alcohol abuse)
* or physical conditions (i.e., significant hepatic or renal dysfunction and significant cardiovascular disease such as heart failure, stroke and transient ischaemic attacks) that would preclude full participation in the study;
* current treatment for obesity;
* current treatments known to affect eating or weight (e.g., medications);
* pregnancy.

Primary outcomes:
measure: Weight
timeFrame: baseline, post-treatment, one-year follow-up
Secondary outcomes:
measure: obesity-specific quality of life, mood disturbance, eating disturbance, cognitive disturbance
timeFrame: baseline, post-treatment, one-year follow-up
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Metabolism and Obesity Services, Royal Prince Alfred Hospital
state: New South Wales
Study officials:
affiliation: University of Sydney
name: Elizabeth Rieger, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05424146: Efficacy of Evidence-Based PTSD Treatment Via Prebiotic Supplementation
Official title: Enhancing the Efficacy of Evidence-Based PTSD Treatment Via Microbiota-Directed Prebiotic Supplementation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Disorder
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: Cures Within Reach
First posted: 2022-06-21
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Posttraumatic stress disorder (PTSD) is a debilitating psychiatric disorder, which results from exposure to traumatic events. Veterans are more than twice as likely to suffer from PTSD compared to civilians. Current interventions for the treatment of PTSD are evidence-based psychotherapies, such as Cognitive Processing Therapy (CPT). Therefore, we plan to compare Cognitive Processing Therapy (CPT) with and without a novel prebiotic bar designed to beneficially modulate the microbiota to determine the utility of this combined approach to positively impact PTSD symptoms. We will conduct a 12-week randomized, double-blind, placebo-controlled, cross-sectional trial in veterans with PTSD. Participants will be randomized to receive CPT + prebiotic or CPT + placebo. They will be provided a supply of prebiotic or non prebiotic bars for 12 weeks. At three different time points, participants will complete questionnaires and complete questionnaires and produce a stool sample ( weeks 1,2, and 12). All participants will be recruited from the two-week in-person Intensive Outpatient Program (IOP) at the Rush Road Home Program, where they will be receiving CPT.


Eligibility criteria: Inclusion Criteria:

* Veterans who are participating in the Rush Road Home Program 2-week Intensive Outpatient Program (IOP) and have the ability to consent.
* Ability and willingness to consume up to two prebiotic bars daily and collect stool samples.

Exclusion Criteria:

* Active suicidality or homicidality, current engagement in significant non-suicidal self harm, history of mania or psychosis, current eating disorders, and/or current substance use that would require medical observation if discontinued.
* Gastrointestinal disease: (1) prior intestinal resection, (2) history of GI disease (except for hiatal hernia, nonproton pump inhibitor requiring gastroesophageal reflux disease, or hemorrhoids), (3) known renal disease or abnormal liver function, (4) antibiotic use within the previous 12 weeks, (5) a plan to have a major change in dietary habits during the study.
* Allergy to almonds, flax seed or coconuts

Primary outcomes:
measure: Change in PTSD symptoms scores
timeFrame: 12 weeks
measure: Changes in microbiota community structure & function
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References: