louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00041548: Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation
Official title: Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Lung Disease
Hypoxemia
Respiratory Acidosis
Lead sponsor: Mallinckrodt
Sponsor class: INDUSTRY
First posted: 2002-07-11
Enrollment: 7
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to evaluate whether administration of nitric oxide (NO)gas by oxygen hood at 20 ppm significantly increases PaO2, as compared to placebo gas (oxygen), within one hour of initiation and with no significant adverse effects.

Detailed description: It is possible that administration of inhaled NO to neonates with abnormal gas exchange earlier, rather than later as a rescue therapy in a moribund state, might accelerate the transition of the circulation from the fetal to neonatal physiology and improve oxygenation. This may in turn decrease the need for mechanical ventilation, its associated morbidity and perhaps even ECMO.

This study is designed as a pilot study to evaluate the physiologic efficacy (rather than effect on clinical outcomes) of NO administered by hood in improving oxygenation of neonates with elevated A-a DO2.

Eligibility criteria: Inclusion criteria:

* Gestational age \>34 completed weeks (\>=35)
* Age \<48 hours
* A-a DO2 400 to 600, on two post-ductal arterial blood gases one hour apart, while on 100% O2 by oxygen hood
* Post-ductal arterial access
* Admitted to The University of Alabama Birmingham Regional NICU

Exclusion criteria:

* Cardiac disease (structural disease with right to left or mixing lesions), not including patent ductus arteriosus (PDA) or patent foramen ovale (PFO)
* Rapid deterioration requiring mechanical ventilation before entry into the study
* Major malformations
* Major neurologic or metabolic disorder or other illness leading to hypoventilation and hypercarbia

Primary outcomes:
measure: PaO2 level
timeFrame: at baseline, then every hour for 6 hours
Secondary outcomes:
measure: Methemoglobin level
timeFrame: at baseline then every hour of treatment
measure: Alveolar-arterial oxygen gradient and ratio
timeFrame: after 1 hour of treatment
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Waldemar Carlo, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ambalavanan N, El-Ferzli GT, Roane C, Johnson R, Carlo WA. Nitric oxide administration using an oxygen hood: a pilot trial. PLoS One. 2009;4(2):e4312. doi: 10.1371/journal.pone.0004312. Epub 2009 Feb 2.
Clinical trial NCT03708848: Tailored Therapy for Helicobacter Pylori Treatment in Patients With Penicillin Allergy
Official title: Antibiotic Susceptibility-based Tailored Therapy for Helicobacter Pylori Treatment in Patients With Penicillin Allergy: a Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
Tailored therapy
Penicillin allergy
Antimicrobial susceptibility testing
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2018-10-17
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: After antimicrobial susceptibility testing of Helicobacter pylori from biopsy samples, according to antibiotic resistance pattern of each one, give esomeprazole 20mg bid, bismuth potassium citrate 600mg bid and two sensitive ones of clarithromycin, metronidazole,levofloxacin and tetracycline.
Primary purpose: TREATMENT

Brief summary: Increasing drug resistance presents a significant challenge to the efficacies of common empiric eradication regimens for Helicobacter pylori treatment in the mainland of China. Tailored therapy may be the best choice to achieve good efficacy, especially in patients with penicillin allergy. Few studies had evaluated the patients with penicillin allergy.This study is designed to evaluate the efficacy and safety of antibiotic sensitivity-based tailored therapy for Helicobacter pylori treatment in the patients with penicillin allergy.


Eligibility criteria: Inclusion Criteria:

* Participants with penicillin allergy who have non-ulcer functional dyspepsia or scarred peptic ulcer disease
* Ability and willingness to participate in the study and to sign and give informed consent
* confirmed H. pylori infection

Exclusion Criteria:

* Patients without penicillin allergy
* Less than 18 years old
* With previous gastric surgery
* Major systemic diseases
* Pregnancy or lactation
* Allergy to any of the study drugs
* Administration of antibiotics, bismuth, antisecretory drugs in 8 weeks prior to inclusion

Primary outcomes:
measure: Helicobacter pylori eradication rate
timeFrame: Six weeks after completion of therapy
Secondary outcomes:
measure: Rate of adverse effects
timeFrame: Within 7 days after completion of therapy
measure: Compliance rate
timeFrame: Within 7 days after completion of therapy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Hong Lu, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Luo L, Huang Y, Liang X, Ji Y, Yu L, Lu H. Susceptibility-guided therapy for Helicobacter pylori-infected penicillin-allergic patients: A prospective clinical trial of first-line and rescue therapies. Helicobacter. 2020 Aug;25(4):e12699. doi: 10.1111/hel.12699. Epub 2020 May 19.
Clinical trial NCT04525248: Resection Location of Rectum in Laparoscopic Surgery for Slow Transit Constipation
Official title: High Resection vs. Low Resection of Rectum in Laparoscopic Total Colectomy for Slow Transit Constipation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Slow Transit
Constipation
Lead sponsor: Shanghai Minimally Invasive Surgery Center
Sponsor class: OTHER
First posted: 2020-08-25
Enrollment: 78
Sex: ALL
Minimum age (years): 15
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study the recurrence rate of constipation after laparoscopic total colectomy with high resection or low resection of rectum

Detailed description: The investigators are going to study the recurrence rate of constipation after laparoscopic total colectomy with high resection or low resection of rectum. High resection is defined as resection at 12\~15cm from anus and low resection as 6\~8cm.

Eligibility criteria: Inclusion Criteria:

* Diagnosed as constipation according to Rome IV criteria
* Diagnosed as slow transit constipation
* With more than 2 years' drug treatment or with outlet obstruction or with surgical history

Exclusion Criteria:

* Colon cancer
* History of colon, rectum, anus surgery
* With severe cardio, renal, neural disease
* Pregnant patients

Primary outcomes:
measure: 1-year recurrence rate of constipation
timeFrame: 1 year
Secondary outcomes:
measure: 1-year rate of diarrhea
timeFrame: 1 year
measure: perioperative complications
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai MISC
name: Minhua Zheng
role: STUDY_CHAIR
References:
Clinical trial NCT02237248: Function and Scoliosis Surgery
Official title: Functional Testing, and Biomechanics Before and After Scoliosis Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adolescent Idiopathic Scoliosis
Keywords: Adolescent Idiopathic Scoliosis
Functional Movement Screen
Y Balance Test
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-09-11
Enrollment: 15
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that are undergoing spinal fusion surgery to treat idiopathic scoliosis.

Brief summary: The purpose of the study is to examine the changes in function and performance biomechanics in patients undergoing spinal fusion corrective surgery for adolescent idiopathic scoliosis (AIS).

Detailed description: Methods will consist of movement studies, questionnaires, and chart review. The recruited subjects will be followed at the usual clinical schedule of pre-op, 6-week, 3 -, 6- and 12-month post-operative follow-up visits. After signing informed consent, age at time of surgery, height, weight, body composition, leg length will be recorded to be used during data processing. Chart review will further yield data on Cobb angle, Lenke Scoliosis classification, instrumentation used during surgery, and level of spinal fusion. All subjects will be asked to complete assessments of activity level (Marx Score, Tegner Activity Score), general health (EQ-5D), and a validated scoliosis survey (Scoliosis Research Study questionnaire SRS-22). Movement studies will consist of the Lower Quarter Y Balance Test (YBT-LQ), and Functional Movement Screen (FMS), and measures of forward flexion, right and left lateral bending, and right and left trunk rotation. These measures will be assessed preoperatively and at postoperative follow-up visits.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of idiopathic scoliosis
* Patients identified to undergo spinal fusion surgery
* Treated at Duke University Medical Center

Exclusion Criteria:

* Neuromuscular or congenital scoliosis

Primary outcomes:
measure: Change in Lower Quarter Y-Balance Test (YBT-LQ)
timeFrame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
measure: Change in Functional Movement Screen (FMS)
timeFrame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
Secondary outcomes:
measure: Change in Tegner Activity Scale
timeFrame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
measure: Change in Marx Activity Scale
timeFrame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
measure: Change in EQ-5D
timeFrame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
measure: Change in SRS-22
timeFrame: Preoperatively; 6wks, 3mos, 6mos, and 12mos Postoperatively
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Robert K Lark, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05808348: Effects of COVID-19 on the Elderly
Official title: Effect of COVID-19 On Pain, Fear of Falling, Fall Frequency, and Physical Activity Level in the Elderly
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Fear
Falling
Physical Activity
COVID-19
Aged
Keywords: COVID-19
Pain
Fear
Falling
Physical Activity
Aged
Lead sponsor: Kırklareli University
Sponsor class: OTHER
First posted: 2023-04-11
Enrollment: 114
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will be carried out with people aged 65 and over living in Kırklareli/Turkey. Individuals will be divided into 2 groups as the COVID-19 group and the control group, according to whether they have had COVID-19 infection in the last 1 year.

Brief summary: The goal of this observational study is to learn about in former COVID-19 patients. The main questions it aims to answer are:

* are there any association among pain, fear of falling, fall frequency, and physical activity level
* are there any difference between former COVID-19 elders and non-COVID-19 elderly population


Eligibility criteria: Inclusion Criteria:

* Being 65 years or older
* Being cooperative

Exclusion Criteria:

* Refusing to participate in the study
* Having significant vision and hearing problems
* Not completing the study questions

Primary outcomes:
measure: Fear of Falling
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Pain Regions and Pain Severity
timeFrame: through study completion, an average of 6 months
measure: Fall Frequency
timeFrame: through study completion, an average of 6 months
measure: Physical Activity Level
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Kırklareli
country: Turkey
facility: Kırklareli University
Study officials:
References:
Clinical trial NCT00543348: RCT of the Cutting Balloon Versus a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses
Official title: A Randomised-Controlled Study Comparing the Peripheral Cutting BalloonTM (Boston Scientific Co.) With a High Pressure Balloon for the Treatment of Arteriovenous Fistula Stenoses
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stenosis
Keywords: BALLOON ANGIOPLASTY
AUTOGENOUS FISTULA
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2007-10-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The proposed study will investigate the efficacy of the peripheral cutting balloon (PBC) compared to the high pressure balloon in dilating venous stenosis in hemodialysis fistulas.

2. SPECIFIC AIMS

Study endpoints will be:

Primary Endpoint

1. Primary and assisted patency at 6 months

Secondary Endpoints:

1. Procedure effectiveness/residual stenosis
2. Procedure-related complications
3. Primary patency and primary assisted patency 12 months
4. Secondary patency at 6 and 12 months
5. Number/type of secondary interventions.


Eligibility criteria: Inclusion Criteria:

* Dysfunctional fistulas will be recruited based on the presence of clinical and hemodialysis parameters

Exclusion Criteria:

* Arteriovenous prosthetic grafts

Primary outcomes:
measure: Primary and assisted patency
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: GEORGES HADDAD, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01999348: A Study of GANFORT® UD in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT) in a Medical Setting
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma, Primary Open Angle
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-12-03
Enrollment: 1553
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary open-angle glaucoma or ocular hypertension

Brief summary: The study will evaluate patients diagnosed with POAG or OHT who are switched to GANFORT® UD (unit dose of fixed combination bimatoprost and timolol) therapy for medical reasons in accordance with physician standard clinical practice. All treatment decisions lie with the physician.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with primary open-angle glaucoma or ocular hypertension
* Previously prescribed intraocular pressure (IOP)-lowering medication with insufficient IOP control and is now being switched to GANFORT® UD for medical reasons

Exclusion Criteria:

* None

Primary outcomes:
measure: Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
timeFrame: Baseline, Final Visit (Week 8 to 12)
Secondary outcomes:
measure: Physician Assessment of IOP-Lowering Effect in the Study Eye Using a 3-Point Scale
timeFrame: Baseline, Final Visit (Week 8 to 12)
measure: Patient Assessment of Tolerability on a 4-Point Scale
timeFrame: Final Visit (Week 8 to 12)
measure: Physician Assessment of Tolerability on a 4-Point Scale
timeFrame: Final Visit (Week 8 to 12)
measure: Percentage of Patients Who Discontinued Treatment
timeFrame: 12 Weeks
measure: Percentage of Patients Prescribed by the Physician to Continue Treatment
timeFrame: Final Visit (Week 8 to 12)
measure: Physician Assessment of Patient Compliance Compared to Previous Treatment on a 3-Point Scale
timeFrame: Final Visit (Week 8 to 12)
Other outcomes:
Locations:
city: Wiesloch
country: Germany
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Pfennigsdorf S, Eschstruth P, Hasemeyer S, Feuerhake C, Brief G, Grobeiu I, Shirlaw A. Preservative-free bimatoprost 0.03%/timolol 0.5% fixed combination in patients with glaucoma in clinical practice. Clin Ophthalmol. 2016 Sep 20;10:1837-1846. doi: 10.2147/OPTH.S106159. eCollection 2016.
Clinical trial NCT01017848: Urine pH as a Predictor of Diabetes
Official title: Urine pH as a Predictor of Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Keywords: diabetes
urine pH
insulin resistance
metabolic syndrome
development of diabetes
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: Staten Island University Hospital
First posted: 2009-11-23
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult inpatients, nondiabetic, no CKD, no urine infection, no UTO

Brief summary: Urine pH has been lately linked to insulin resistance. The early phase of Diabetes Mellitus involves insulin resistance. Thus, the investigators want to check if a simple cheap study like a urine analysis that can predict diabetes.


Eligibility criteria: Inclusion Criteria:

* age \> 18

Exclusion Criteria:

* diabetes
* CKD
* urine infection
* UTO
* bladder dysfunction

Primary outcomes:
measure: development of diabetes using a predicting formula
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
Study officials:
affiliation: SIUH
name: Suzanne El-Sayegh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01757548: The Effect and Prognosis of Different Operations on Varicocele - a Single-center Clinical Study
Official title: The Effect and Prognosis of Different Operations on Varicocele - a Single-center Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Varicocele; Male Infertile;Varicocelectomy
Keywords: varicocele; male infertile;varicocelectomy
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2012-12-31
Enrollment: 1000
Sex: MALE
Minimum age (years): 10
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether high ligation of spermatic vein by open operation and microsurgery for patients with are effective in the treatment of varicocele and to determine which surgical option is better.


Eligibility criteria: Inclusion Criteria:

* 1.infertile patient suffering from varicocele 2.severe varicocele patient with obvious symptoms 3.adolescents suffering from severe varicocele with or without orchiatrophy

Exclusion Criteria:

* 1.varicocele patient with abdominal infection 2.varicocele patient who has massive adhesion of pelvic tissue due to pelvic surgery history 3.mild varicocele 4.varicocele patient has no obvious symptoms if has have born children, suffer from idiopathic azoospermia，or their partner can't bear children

Primary outcomes:
measure: the quality of semen and the level of sexual hormone
timeFrame: before and three and six months after surgery
measure: complications
timeFrame: one, three and six months postoperation
Secondary outcomes:
measure: If there was pain, visual analogue scale,Numerical rating scale and verbal rating scale would be used to evaluate pain intensity. pain intensity
timeFrame: before and one,three and six months after surgery
Other outcomes:
measure: general information
timeFrame: before surgery
Locations:
city: Guangzhou
country: China
facility: First Affiliated hospital，Sun Yat-Sen University.
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Xiang Zhou Sun, MD，PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06923748: Comparison of Two Interdental Devices for Peri-Implant Plaque Control
Official title: Comparison of Two Different Interproximal Cleaning Devices Around Dental Implants: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peri-implant Mucositis
Peri-Implantitis
Keywords: Peri-implant mucositis
Peri-implantitis
Interproximal devices
Prevention
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized clinical trial aims to compare the efficacy of two interproximal cleaning devices-superfloss and interdental brushes- in patients diagnosed with peri-implant diseases. The study evaluates plaque control and bleeding scores. Patients will be randomly assigned to one of two oral hygiene protocols and will be monitored through clinical examinations and validated questionnaires assessing both clinical and radiographic parameters and patient-reported outcomes.

Detailed description: This single-center, randomized, parallel-arm clinical trial aims to compare the efficacy of superfloss and interdental brushes, used in combination with an electronic toothbrush, in patients with peri-implant diseases. Participants will be randomly assigned to one of two oral hygiene protocols. Clinical assessments will be performed at baseline, 6 weeks, and 3 months, including plaque index, bleeding scores, and probing depth. Radiographic measurements and standardized patient-reported questionnaires (food impaction and oral hygiene self-efficacy) will also be used. The primary outcome is the reduction of plaque and gingival inflammatory scores at implant sites.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 70 years
* Presence of at least one implant loaded for ≥1 year
* Presence of bleeding (≥1 site or line/profuse bleeding) and/or suppuration on gentle probing around the implant
* Systemically healthy adults
* Able to provide written informed consent

Exclusion Criteria:

* Use of anticoagulants, anti-aggregants, antibiotics, or corticosteroids in the past 3 months
* Pregnant or lactating women
* Inability to perform adequate oral hygiene

Primary outcomes:
measure: Change in plaque score at implant sites
timeFrame: through study completion, an average of 3 months
measure: Change in bleeding score at implant sites
timeFrame: through study completion, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Siena
country: Italy
facility: AOUS
Study officials:
References: