louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03007706: Role of Skin Cleansing and Prophylactic Antibiotic in Preventing Infectious Morbidity After Cesarean Section Delivery
Official title: Role of Skin Cleansing and Prophylactic Antibiotic in Preventing Infectious Morbidity After Cesarean Section Delivery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postpartum Infectious Morbidity in Cesarean Section Delivery
Lead sponsor: Minia Maternity University Hospital
Sponsor class: OTHER
First posted: 2017-01-02
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women undergo cesarean section delivery whether elective or emergency

Brief summary: This study aims to determine the effectiveness of skin cleansing and prophylactic antibiotics given to women undergoing a cesarean section for reducing the incidence of postpartum infectious morbidity and to assess potential maternal adverse effects and any impact on the infant.


Eligibility criteria: Inclusion Criteria:

1. Women undergoing cesarean delivery, both elective and non-elective.
2. Rupture of membranes and labor contractions will be allowed.

Exclusion Criteria:

1. Unknown outcome from the patient.
2. Refusing to participate in the study from the admission conse
3. Allergy to antibiotics.
4. Any visible infection.

Primary outcomes:
measure: role of skin cleansing and prophylactic antibiotics given to women undergoing a cesarean section for reducing the incidence of postpartum infectious morbidity
timeFrame: 2 weeks following cesarean section
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05048706: SP TLF Versus Ho:YAG Laser
Official title: Comparative Effectiveness of the Super Pulse Thulium Fiber Laser (SP TLF) for Laser Lithotripsy of Urinary Calculi
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Calculi
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2021-09-17
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects eligible for this study will be identified via eRecord in the Urology Department (routine access) of patients who were diagnosed with upper urinary tract calculi who underwent surgery utilizing either high powered Ho:YAG or TL-SPL lasers.

Brief summary: The investigators aim to compare the performance of the Super Pulse Thulium fiber laser (SP TFL) with that of the standard Holmium: Yttrium-Aluminium-Garnet (Ho:YAG) laser. The investigators hypothesize that the electronically-modulated laser diodes, of the TFL offers the most comprehensive and flexible range of laser parameters among laser lithotripters leading to more efficient (4 times more) and effective stone dusting resulting in production of finer dust particles obviating the need for postoperative ureteric stenting which remains a major source of patient discomfort.


Eligibility criteria: Inclusion Criteria:

* Patient is scheduled to undergo mini-PCNL and/or RIRS surgery at the University of Rochester Medical Center for the management of upper urinary tract calculi (i.e. kidney and proximal ureter)
* Stones located in the kidney and proximal ureter
* Stones measuring 10-30mm
* Ability to give informed consent
* Any racial or ethnic origin
* Age 18 years and older

Exclusion Criteria:

* Active kidney infection
* Patients with prior stenting
* Pregnant patients
* Patients with solitary kidney
* Patients with ureteral tumor or stricture
* Inability to give informed consent
* Not age 18 and older

Primary outcomes:
measure: To determine the efficiency of SP TFL in dusting stones
timeFrame: 6 months
measure: Mean ablation energy needed to ablate stone volume
timeFrame: 6 months
Secondary outcomes:
measure: Number of stones cleared.
timeFrame: 9 months
measure: Number of participants reporting complications.
timeFrame: 9 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: Associate Professor
name: Ahmed Ghazi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03555006: Tele-ultrasound Experimentation: Cooperation Protocol Between Electro-radiology Assistant and Remote Radiologist
Official title: Tele-ultrasound Experimentation: Cooperation Protocol Between Electro-radiology Assistant and Remote Radiologist for the Realization of Some Exploration Indications by Ultrasound
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tele-ultrasound
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2018-06-13
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study tries to evaluate the non-inferiority quality and safety of ultrasound examinations realise by electro-radiology assistant with a remote radiologist compared to those realize by electro-radiology assistant with a referent radiologist on site.

Detailed description: The number of requests for medical imaging examinations is clearly growing while there is an understaffing among the radiologists. The solution is the amelioration of information transmission technologies, for organize a territorial teleradiology in order to care duty. Currently, in the ultrasound field, the investigators can't realize image transfer because analyse and expertise are made during examination and only reading of fixed images can't be enough for the examination interpretation.

The most part of other developed countries recognize a paramedical job devoted to ultrasound. Tele-ultrasound is used in expert resort, for example during high-risk pregnancy.

A French society commercializes tele-ultrasound robots, arranged by a caregiver beside sick person and a tele-radiologist realize acquisition of information and images with remote commands from robot.

The CHR Metz-Thionville has a cooperation protocol between electro-radiology assistants and radiologists for the ultrasound practical, endorsed by Lorraine ARS and HAS (French health organizations) since 2012, and currently national impact.

This study purpose to evaluation the non-inferiority of agreement between two interpretations of the same ultrasound realize by an electro-radiology assistant on the one hand by two radiologists present in the radiology service and on the other hand, one radiologist in by the radiology service and one remote radiologist.

Eligibility criteria: Inclusion Criteria:

* Major patient
* Who needs abdomino-pelvic ultrasound, except emergency cases
* With no substitutable examination

Exclusion Criteria:

* Pregnant and nursing women
* Patient in the incapacity to express his consent
* Unavailability of a remote radiologist or a second local radiologist during the examination realization
* Patient opposed to use data

Primary outcomes:
measure: Percentage of consistency between the reports
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz Thionville
Study officials:
affiliation: CHR Metz Thionville
name: Elisabeth PARIZEL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00831506: Dimebon (PF-01913539)-Digoxin Drug-Drug Interaction Study In Healthy Subjects
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Two-Way Crossover Study To Evaluate The Steady-State Effect Of Dimebon (PF-01913539) On The Safety, Tolerability, And Steady-State Pharmacokinetics Of Digoxin In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer Disease
Huntington Disease
Keywords: digoxin dimebon drug-drug interaction study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Medivation, Inc.
First posted: 2009-01-29
Enrollment: 12
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: This study has been designed to confirm, in healthy subjects, the lack of a clinically important pharmacokinetic interaction between Dimebon, at the proposed maximum commercial dose of 20 mg TID (administered every 8 hours), and digoxin (Lanoxin®) 0.125 mg QD, a sensitive P-gp substrate recommended by FDA.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* A known history of hypersensitivity or previous intolerance to Dimebon or digoxin.
* Evidence or history of clinically significant hematological, renal, endocrine,pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic,seasonal allergies at time of dosing) disease or clinical findings at screening.
* Pregnant or nursing women; women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception as outlined in the protocol from at least 14 days prior to the first dose of study medication.

Primary outcomes:
measure: AUC24 and Cmin of digoxin on Day 14
timeFrame: Day 14
Secondary outcomes:
measure: Cmax, Tmax, Ae, and renal clearance of digoxin on Day 14
timeFrame: Day 14
measure: Adverse event monitoring through Day 14 including physical/neurological examination findings
timeFrame: Day 14
measure: Clinical safety assessments through Day 14 including chemistry, hematology, and vital signs
timeFrame: Day 14
measure: 12-lead ECGs through Day 14
timeFrame: Day 14
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00139906: Twice Daily Titration Study of Bifeprunox in Subjects With Schizophrenia
Official title: A Randomized, Double-Blind, Placebo-Controlled, Twice Daily Titration Study of the Safety and Tolerability of Bifeprunox in Subjects With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Titration Study
Schizophrenia
BID dosing
Pharmacokinetic
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2005-08-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is to assess the safety and tolerability of a five-day titration schedule (using twice daily dosing for the first three days) to achieve the highest proposed dose of 40 mg daily. The study duration is two months.


Eligibility criteria: Inclusion Criteria:

* Subjects who have current diagnosis of Schizophrenia or Schizoaffective disorder
* Body weight of 100-250 lbs
* Male or females
* 18-55 years of age

Exclusion Criteria:

* Subjects who are acutely psychotic
* Subjects with current Axis I primary psychiatric diagnosis other than schizophrenia, at significant risk of suicide

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: National City
country: United States
facility: Site 1
state: California
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References:
Clinical trial NCT01042106: Safety, Pharmacokinetics and Pharmacodynamics of DSP-8658 in Patients With Type 2 Diabetes Mellitus and Healthy Adults
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple Ascending Oral Dose Study to Evaulate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of DSP-8658 in Type 2 Diabetic and Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2010-01-05
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple ascending doses of DSP-8658 in patients with Type 2 diabetes mellitus and healthy adults.


Eligibility criteria: Inclusion Criteria: Diabetic subjects

* Age ≥ 18 and ≤ 65 years
* Body Mass Index ≤45
* Drug naive type 2 diabetes or type 2 diabetes previously treated with an oral antidiabetic drug

Inclusion Criteria: Healthy subjects

* Age ≥ 18 and ≤ 65 years
* Body Mass Index ≥ 18 and ≤ 29
* Good health as determined by medical history, ECG, clinical chemistry, hematology, urinalysis, virology, and a physical examination.

Exclusion Criteria: Diabetic subjects

* Have a current or expected requirement for any antidiabetic or lipid-lowering drug

Exclusion Criteria: Healthy subjects

* Have, or have had a history of clinically significant neurological, urological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, or other major disorders including cancer

Primary outcomes:
measure: Safety assessments include physical examination, laboratory variables and ECG.
timeFrame: 20 days
Secondary outcomes:
measure: Pharmacokinetics of DSP-8658 and its metabolites: levels of DSP-8658 and its metabolites will be measured and analyzed at various time points throughout the study.
timeFrame: 20 days
measure: Pharmacodynamics of DSP-8658 (how DSP-8658 acts in the body to affect glucose and lipid control): glucose and lipid levels will be measured at various time points throughout the study.
timeFrame: 18 days
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Cetero Research
state: Texas
Study officials:
affiliation: Sumitomo Pharma America, Inc.
name: Medical Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04765306: Fascial Closure Technique After Gynecologic Laparoscopic Surgery and Postoperative Pain
Official title: Fascial Closure Technique After Gynecologic Laparoscopic Surgery and Postoperative Pain: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 123
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our study aims to determine postoperative pain outcomes when comparing port site \> 10 mm fascial closure with traditional direct closure versus use of laparoscopic fascial closure device in patients undergoing minimally invasive gynecologic surgery via laparoscopic or robotic techniques. Pain outcomes will be measured using the visual analog scale.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 or older.
* Any patient undergoing laparoscopic gynecologic surgery with one left upper quadrant port site \> 10 mm via either robotic or traditional laparoscopic techniques for any indication including abnormal bleeding, pelvic pain, gynecologic cancer, uterine fibroids, etc. Procedures performed will include but not be limited to hysterectomy, bilateral or unilateral salpingoophorectomy, ovarian cystectomy, and pelvic floor support procedures.
* Patients willing and able to give informed consent.
* Patients capable and willing to return for follow up and complete pain diaries.

Exclusion Criteria:

* Patients unable to return for follow up.
* Patients undergoing laparoscopic surgery that requires conversion to laparotomy.
* Patients undergoing laparoscopic surgery that does not require a port site \>10 mm.

Primary outcomes:
measure: Postoperative pain scores via Visual Analog Scale
timeFrame: Through 2 weeks postoperatively
Secondary outcomes:
measure: Quantity of narcotics consumed in postoperative period
timeFrame: Through 2 weeks postoperatively
measure: Length of hospital stay
timeFrame: Through study completion, up to 6 months
measure: Postoperative complication
timeFrame: Through 6 weeks postoperatively
measure: Fascial closure operating time
timeFrame: Duration of fascial closure operating time
Other outcomes:
Locations:
city: Chattanooga
country: United States
facility: Erlanger Baroness Hospital
state: Tennessee
Study officials:
affiliation: University of Tennessee College of Medicine Gynecology Oncology
name: Todd Boren, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tennessee Chattanooga Minimally Invasive Gynecologic Surgery Fellow
name: Jessica G Putman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00695006: Manual Therapy, Exercise and Traction for Patients With Cervical Radiculopathy: A RCT
Official title: Manual Therapy, Exercise and Traction for Patients With Cervical Radiculopathy: A RCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Radiculopathy
Keywords: manual therapy, cervical traction, cervical radiculopathy
Lead sponsor: Rocky Mountain University of Health Professions
Sponsor class: OTHER
First posted: 2008-06-11
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To date, optimal strategies for the management of patients with Cervical Radiculopathy (CR) remain elusive. The purpose of this study was to compare the effects of manual therapy, exercise, and cervical traction to manual therapy, exercise, and sham traction on pain, function and disability in patients with CR.


Eligibility criteria: Inclusion Criteria:

* 3 of 4 positive on CPR, 18-70yrs

Exclusion Criteria:

* history of previous cervical or thoracic spine surgery
* bilateral upper extremity symptoms
* signs or symptoms of UMN disease
* medical "red flags"(tumor, fracture, rheumatoid arthritis, osteoporosis, prolonged steroid use)
* cervical spine injections (steroidal) in the past two weeks
* current use of steroidal medication prescribed for their radiculopathy symptoms

Primary outcomes:
measure: Neck Disability Index
timeFrame: 2wk, 4wk, 3mo, 6mo
measure: Patient Specific Functional Scale
timeFrame: 2wk, 4wk, 3mo, 6mo
measure: Numeric Pain Rating Scale
timeFrame: 2wk, 4wk, 3mo, 6mo
Secondary outcomes:
measure: Global Rating Of Change
timeFrame: 2wk, 4wk, 3mo, 6mo
measure: Body Diagram
timeFrame: 2wk, 4wk, 3mo, 6mo
measure: Fear Avoidance Belief Questionnaire
timeFrame: 2wk, 4wk, 3mo, 6mo
measure: Satisfaction
timeFrame: 2wk, 4wk, 3mo, 6mo
measure: Grip Strength
timeFrame: 2wk, 4wk
Other outcomes:
Locations:
city: Fredericksburg
country: United States
facility: Advance Rehab at Fredericksburg Orthopaedics
state: Virginia
Study officials:
affiliation: Advance Rehab at Fredericksburg Orthopaedics
name: Ian A Young, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06512506: Prospective Cohort Study of Arthroscopic Treatment of Hip Dysplasia
Official title: Prospective Cohort Study of Arthroscopic Treatment of Hip Dysplasia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Developmental Dysplasia of the Hip
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 47
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of borderline hip dysplasia with glenolabial injury. (For example, there are no clinical symptoms of simple critical hip dysplasia, and hip pain may occur when combined with glenolabial injury

Brief summary: On the basis of the database established in the previous stage, a cohort analysis was conducted on patients with BDDH complicated by hip arthroscopy for minimally invasive treatment of glenoid and lip injury, according to which the indications of minimally invasive surgery for BDDH patients were optimized and surgical measures were improved. Achieve accurate and rapid repair, rehabilitation and functional recovery, serve national fitness, and treat people's injuries

Detailed description: Based on the work of the previous research group, we prospective constructed a bidirectional cohort of patients with critical hip dysplasia, and summarized the influencing factors for the surgical prognosis of patients with BDDH, so as to continuously optimize patient selection. On this basis, the cohort size was extended to analyze the difference in efficacy between arthroscopic glenolabial repair and glenolabial repair combined with soft tissue enhancement, and further improve the minimally invasive surgery to promote the efficacy of minimally invasive surgery in BDDH patients

Eligibility criteria: Inclusion Criteria:

- Diagnosis of borderline hip dysplasia with glenolabial injury.

Exclusion Criteria:

-

Primary outcomes:
measure: Improved Harris hip score
timeFrame: Preoperative, 24 months after surgery
measure: PRO rating
timeFrame: Preoperative, 24 months after surgery
measure: Cartilage damage outerbridge grading
timeFrame: Preoperative, 24 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital Medicial Science Research Ethics Committee
Study officials:
affiliation: Peking University Third Hospital
name: Jianquan J Wang, M.D.
role: STUDY_CHAIR
References: