louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01172574: Motor Control Exercise in Osteoporotic Women
Official title: Motor Control Exercise Can Reduce Pain and Improve Postural Alignment in Osteoporotic Women With Vertebral Fractures: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Postmenopausal
Keywords: Osteoporosis
Pain
Kyphosis
Posture
Exercise therapy
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2010-07-30
Enrollment: 20
Sex: FEMALE
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study was to explore the effectiveness of Motor Control Exercise on pain, postural alignment and spinal curvatures in women with osteoporotic vertebral fractures.

Detailed description: Osteoporosis is a common metabolic bone disease that usually affects the aging population. It is an important public health problem, due to its association with vertebral and nonvertebral fractures leading to increased morbidity. Vertebral fractures are accompanied by kyphosis, reduced pulmonary function, loss of height, and are often associated with elevated pain while they may also lead to subsequent vertebral fractures. Osteoporotic individuals exhibit kyphosis in the erect standing position, which, in turn, is compensated by the deformation of other parts of the body. Improvement of postural alignment may lead to less stress on the spine, facilitate posture and proper body mechanics and may improve balance. The aim of the present study was to assess the effectiveness of Motor Control Exercise on pain, postural alignment and spinal curvatures in women with osteoporotic vertebral fracture against the results of a control group that received the basic therapies for osteoporosis.

Eligibility criteria: Inclusion Criteria:

* Postmenopausal osteoporosis
* Osteoporotic vertebral fractures
* Pain
* Under medical osteoporotic treatment

Exclusion Criteria:

* osteoporosis other than primary postmenopausal
* vertebral collapse with neurological deficits
* more than 5 fractured vertebrae
* major respiratory conditions
* receiving pain reducing agents, teriparatide or calcitonin

Primary outcomes:
measure: Pain
timeFrame: Baseline
measure: Pain
timeFrame: 3 months
measure: Pain
timeFrame: 6 months
Secondary outcomes:
measure: Photographic measurements
timeFrame: Baseline
measure: Spinal curvatures
timeFrame: Baseline
measure: Photographic measurements
timeFrame: 3 months
measure: Spinal curvatures
timeFrame: 3 months
measure: Photographic measurements
timeFrame: 6 months
measure: Spinal curvatures
timeFrame: 6 month
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Hospital Thias Pronoias 'I Pammakaristos'
state: Attica
Study officials:
References:
Clinical trial NCT04280874: Induction of Labor in Term Pregnancies With Unfavourable Cervix
Official title: Comparison of Intracervical and Intravaginal Application of Prostaglandin E2 for Induction of Labour in Term Pregnancies With Unfavourable Cervix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Induction of Labor Affected Fetus / Newborn
Prostaglandins Causing Adverse Effects in Therapeutic Use
Keywords: dinoprostone
Bishop score
labor induction
term pregnancy
Lead sponsor: Clinical Hospital Merkur
Sponsor class: OTHER
First posted: 2020-02-21
Enrollment: 212
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 212 pregnant women are randomly assigned into 2 groups for application of one of two dinoprostone agents used for labor induction (intravaginal or intracervical dinoprostone)
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized trial comparing two prostaglandin E2 (dinoprostone) agents used for labor induction in pregnant women with term pregnancies and unfavorable cervix.

Detailed description: This prospective randomized trial includes pregnant women with term pregnancies, indication for labor induction and an unfavorable cervix. These women are randomized into two groups: one group is induced using an intracervical prostaglandin E2 (PGE2, dinoprostone) formulation, the other using an intravaginal PGE2 formulation. Main outcome is time period between beginning of labor induction to delivery, and a reduction of four hours is considered clinically significant.

Eligibility criteria: Inclusion Criteria:

* term pregnancies (\> 37 weeks gestation)
* unfavourable cervix (Bishop score \<6)
* indication for labor induction
* absence of uterine contractions
* reassuring cardiotocography

Exclusion Criteria:

* ruptured membranes
* scar uterus (previous caesarean section or uterus surgery)
* pregnancy complications: intrauterine growth restriction; oligohydramnios, pre-eclampsia, non-reassuring/pathological cardiotocography, cholestasis in pregnancy, diabetes mellitus, multifetal pregnancy, breech presentation

Primary outcomes:
measure: time period between beginning of labor induction to delivery
timeFrame: 5 days
Secondary outcomes:
measure: number of births within 24h of start of labor induction
timeFrame: 7 days
measure: number of deliveries by caesarean section or instrumental deliveries
timeFrame: 7 days
measure: number of uterus hyperstimulation
timeFrame: 7 days
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: Clinical Hospital Merkur
Study officials:
affiliation: Clinical Hospital Merkur
name: Katja Vince, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02807974: Study of CS-3150 in Hypertensive Patients With Type 2 Diabetes and Albuminuria
Official title: A Study of CS-3150 to Evaluate Efficacy and Safety in Hypertensive Patients With Type 2 Diabetes and Albuminuria.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension with Type 2 Diabetes and Albuminuria
Diabetic nephropathy
Diabetic renal disease
Albuminuria
Mineralocorticoid receptor antagonist
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2016-06-21
Enrollment: 51
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To examine antihypertensive effect and safety of administration of CS-3150 in combination with ARB or ACE inhibitor in hypertensive patients with type 2 diabetes and albuminuria.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects aged 20 to 80 years at informed consent
* Subjects with type 2 diabetes and albuminuria (urine albumin-to-creatinine ratio ≥ 30, \< 1000 mg/g/Cr)
* Subjects with hypertension (Sitting SBP ≥ 140 mmHg, \<180 mmHg and Sitting DBP ≥ 80 mmHg, \<110 mmHg
* Treatment with an ARB or ACE inhibitor
* eGFR ≥ 30 mL/min/1.73m\^2

Exclusion Criteria:

* Secondary hypertension or malignant hypertension
* Type 1 diabetes
* Secondary glucose intolerance
* Diagnosed with non-diabetic nephropathy
* Serum potassium level \< 3.5 or ≥ 4.8 mEq/L

Primary outcomes:
measure: Change from baseline in sitting systolic and diastolic blood pressure
timeFrame: Baseline to end of Week 12
Secondary outcomes:
measure: Time course of systolic and diastolic blood pressure
timeFrame: Baseline to end of Week 12
measure: Proportion of patients achieving blood pressure control
timeFrame: Baseline to end of Week 12
measure: Change rate from baseline in urine-albumin-to-creatinine ratio
timeFrame: Baseline to end of Week 12
measure: Time course of urine-albumin-to-creatinine ratio
timeFrame: Baseline to end of Week 12
Other outcomes:
Locations:
city: Sanuki-shi
country: Japan
state: Kagawa
Study officials:
References:
Clinical trial NCT00649974: Fasting Study of Valacyclovir Hydrochloride Tablets 1000 mg and Valtrex® Tablets 1000 mg
Official title: Single-Dose Fasting In Vivo Bioequivalence Study of Valacyclovir Hydrochloride Tablets (1000 mg; Mylan) to Valtrex® Tablets (1000 mg; GlaxoSmithKline) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The objective of this study was to investigate the bioequivalence of Mylan's valacyclovir hydrochloride 1000 mg tablets to GlaxoSmithKline's Valtrex® 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose administered under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria:

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study

Primary outcomes:
measure: The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
timeFrame: blood collections through 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Kendle International Inc.
state: West Virginia
Study officials:
affiliation: Kendle International Inc.
name: Dorian Williams, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03171974: Ultrasound Guided Treatment of Steroids for Capsular Contracture in Patients With Reconstructed/Augmented Breast
Official title: Ultrasound Guided Treatment of Steroids for Capsular Contracture in Patients With Reconstructed/Augmented Breast
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Capsular Contracture, Implant
Keywords: breast capsular contructure
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: one treatment group
Primary purpose: TREATMENT

Brief summary: Ultrasound guided treatment of steroids for capsular contracture in patients with reconstructed/augmented breast

Detailed description: The aim of this study is to evaluate ultrasound (US)-guided treatment of capsular contracture (CC) in patients with reconstructed/ augmented breast.

Capsular contraction is the one of the most common complications of both esthetic and reconstructive breast surgery with an incidence of 0.5-30% and 1-38%, respectively. In irradiated patients the incidence is higher, in the range of 30-67%. It appears most commonly in the first year but in some patients, belated capsular contracture has been noticed. The more severe forms of contraction, Baker grades 3 and 4 with a firm often deformed and painful breast, have been shown to recur as often as 67% after capsulotomy

steroid injection has been demonstrated to be effective for the treatment of this condition.

20-30 female with grade III\\IV CC will be included. Patients will be treated with peri-implant US-guided injection of Dexamethasone

The purpose of our study is to use a longer acting steroid (Dexamethasone) injected intra capsular with US-guide. By that getting a better effect on the level of fibrosis.

This Clinical study will be conducted in the tertiary academic Rabin Medical Center.

Several measures will be taken, including: capsular contracture grading by two plastic surgeons, a VAS-score of breast pain, maximal capsular thickness (MCT) in sonography

Eligibility criteria: Inclusion Criteria:

• female patient with grade 3-4 capsular contraction after alloplastic breast reconstruction\\ augmentation

Exclusion Criteria:

* intake of steroids, anti-inflammatory, anti-coagulate or immunomodulatory medications on a regular basis
* Patients with skin atrophy of the breast

Primary outcomes:
measure: reducing maximum capsular thickness (MCT)
timeFrame: 3.5 years
measure: reduce pain
timeFrame: 3.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
state: IL
Study officials:
affiliation: Rabin Medical Center
name: Muhammad Mansour, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05725174: Volatile Non-Invasive Biomarkers of Epileptic Seizures
Official title: Volatile Non-Invasive Biomarkers of Epileptic Seizures
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epilepsy
Non-Epileptic Seizure
Lead sponsor: University College London Hospitals
Sponsor class: OTHER
Collaborators: name: Imperial College London
First posted: 2023-02-13
Enrollment: 270
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: People with a diagnosis of epileptic or non-epileptic seizures

Brief summary: Breath and sweat samples will be collected from people who have been admitted to hospital after a potential seizure and analysed by the team. The researchers then hope to identify a pattern of small molecules that can distinguish seizures from other events, and perhaps determine the severity of the seizure.

Detailed description: Determining whether someone has had an epileptic seizure, or another event, can be challenging and result in the wrong diagnosis. A 'seizure test' used after the event would therefore be very helpful.

Researchers have used small molecules released from the body in breath and sweat to detect cancers and other diseases; this study will determine whether a similar method can be used to detect whether someone has had an epileptic seizure.

Eligibility criteria: Inclusion Criteria:

1. Patients who have been admitted to either University College London's Queen's Square EEG-telemetry unit or Chalfont Centre for Epilepsy, for diagnosis of seizure events.
2. Patients aged 18 years or above

Exclusion Criteria:

1. Patients with active infection or who have taken antibiotics within 4 weeks
2. Patients on immunosuppressive medications
3. Patients with co-morbidities preventing breath collection
4. Patients unable to provide informed consent.

Primary outcomes:
measure: Distinguishing epileptic from non-epileptic seizures
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Chalfont Centre for Epilepsy
state: Buckinghamshire
city: London
country: United Kingdom
facility: National Hospital for Neurology and Neurosurgery
Study officials:
affiliation: Professor
name: Matthew Walker, MB BChir FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04906174: Effect of Materials for Subcuticular Suture (Quill vs. Monocryl) on Complications After Liver Resection
Official title: Effect of Materials for Subcuticular Suture (Quill® vs. Monocryl®) on Complications After Liver Resection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver and Intrahepatic Bile Duct Neoplasm
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2021-05-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing liver resection at MD Anderson Cancer Center from June 1, 2020 through January 31, 2021

Brief summary: This study investigates the effect of materials used in subcuticular suture on patients' outcomes after surgery. The prevention of surgical site wound infection is important to decrease the length of hospital stay and the post-operative risk of incisional hernia, especially in patients undergoing open hepatectomy (surgical removal of the liver). The purpose of this study is to compare the impact of the use of Quill versus Monocryl for subcuticular suture on patients' outcomes after surgery.

Detailed description: PRIMARY OBJECTIVE:

I. To investigate the impact of materials for subcuticular suture (Quill versus \[vs.\] Monocryl) on complications after liver resection.

OUTLINE:

Patients' medical records are reviewed retrospectively.

Eligibility criteria: Inclusion Criteria:

* Patients \>= 18 years of age undergoing liver resection at MD Anderson Cancer Center from June 1, 2020 through January 31, 2021

Exclusion Criteria:

* Patients who have a history of previous abdominal surgery will be excluded
* Pregnant women will not be included in this chart review

Primary outcomes:
measure: Incidence of complications after liver resection
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Jean-Nicolas Vauthey
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01238874: Latin America Cardiac Resynchronization Therapy Study
Official title: Latin America Cardiac Resynchronization Therapy Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Heart Failure.
Lead sponsor: Medtronic Latin America
Sponsor class: INDUSTRY
First posted: 2010-11-11
Enrollment: 200
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Latin America CRT Study is a prospective, multicenter, interventional post-market release study conducted in Latin America. The geography includes Puerto Rico and the Caribbean, Mexico and Central America, and South America.

Detailed description: The purpose of this study is to provide local evidence regarding Cardiac Resynchronization Therapy (CRT), in both pacing and defibrillation devices across Latin America. The primary objective will focus on changes in left ventricular heart size and function measurements in subjects receiving CRT therapy. The following additional parameters will also be collected:

* Data on referral patterns in Latin America;
* Data on device implant (including delivery system, device information, and lead information);
* Clinical data on subject outcomes and changes (improved, unchanged, or worsened) in heart failure status as assessed by heart failure (HF) hospitalizations, New York Heart Association (NYHA) class, mortality, and Quality of Life (QOL) measured by the Patient Global Assessment;

Eligibility criteria: Inclusion Criteria: Implant of new CRT-D or CRT-P device (first-time implant), ACC/AHA/HRS/ESC guidelines for implant, NYHA Class II, III or IV, QRS duration \>120 ms, LVEF \< 35%, Receiving optimal medical/drug therapy, Able to give written informed consent, Are \> 21 years of age, Must be able to return for follow-up visits as required, Are not pregnant or do not plan to get pregnant within the next 6 months, Have no physical limitations to perform Echo studies

Exclusion Criteria: Previous or existing CRT system implanted, Unwilling or unable to comply with specified follow-up schedule, Enrolled or intending to participate in another device study during the course of this study that requires specific treatment or device programming, Medical condition that may limit life expectancy to \< 6 months

Primary outcomes:
measure: Measure heart size and function changes as assessed by Doppler echocardiogram (Echo).
timeFrame: 6 Months
Secondary outcomes:
measure: referral patterns; Report on device implant; Analyze subject clinical status as it pertains to heart failure (HF) hospitalizations, changes in NYHA class, mortality and QOL (Patient Global Assessment);
timeFrame: 6 Months
Other outcomes:
Locations:
city: Tijuana
country: Mexico
facility: Hospital Angeles Tijuana
state: Baja California
city: Leon
country: Mexico
facility: Hospital Angeles Leon
state: Guanajuato
Study officials:
References:
Clinical trial NCT03877874: The Impact of Anti- Asthmatic Medications on Salivary pH and Dental Caries Pattern in a Group of Egyptian Children With Bronchial Asthma
Official title: The Impact of Anti- Asthmatic Medications on Salivary pH and Dental Caries Pattern in a Group of Egyptian Children With Bronchial Asthma: A Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: pH
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-03-18
Enrollment: 58
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All patients presented to the Asthma and Allergy Outpatients Clinic of Abu El-Reesh Japanese hospital for kids will be included in the study according to the following criteria.

-Control group: All patients attending the pediatric dentistry department of faculty of dentistry of Cairo University will be included in the study according to the following criteria.

Brief summary: The impact of Anti- Asthmatic medications on salivary pH and dental caries pattern in a Group of Egyptian Children with Bronchial Asthma.

Detailed description: Due to lack of published studies about the impact of anti-asthmatic medications on salivary pH and dental caries pattern among the Egyptian children diagnosed with Bronchial Asthma, this study will be conducted to cover this point.

Eligibility criteria: Inclusion Criteria:

* - Children aged 6-12 years old diagnosed with Bronchial asthma (Mixed dentition stage).
* Control group : a matched group aged 6-12 years old
* Patients taking regular medications for the treatment of Bronchial asthma at least for 1 year back
* Both male and female patients will be included.

Exclusion Criteria:

* No other systemic Diseases.

Primary outcomes:
measure: pH of Saliva
timeFrame: 1year
Secondary outcomes:
measure: pattern of Dental caries
timeFrame: 1year
Other outcomes:
measure: Drug composition(pH and total sugar content)
timeFrame: 2 minutes
Locations:
Study officials:
References:
Clinical trial NCT00518674: Local Anesthetics After Total Knee Arthroplasty
Official title: Local Anesthetics After Total Knee Arthroplasty: Intra- vs. Extraarticular Administration? A Randomized, Double-Blind, Placebo-Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Keywords: pain
local infiltration analgesia
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2007-08-21
Enrollment: 32
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 aim of this randomized, double-blind and placebo-controlled study is to evaluate the specific role of injection of local anesthetic into the intra- vs. extraarticular tissues after toal knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

* Able to give informed oral and written consent to participate
* Able to speak Danish

Exclusion Criteria:

* Treatment with opioids
* Body Mass Index \> 40

Primary outcomes:
measure: Visual Analogue Scale pain score
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hvidovre University Hospital, Copenhagen, Denmark
name: Lasse Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andersen LO, Kristensen BB, Madsen JL, Otte KS, Husted H, Kehlet H. Wound spread of radiolabeled saline with multi- versus few-hole catheters. Reg Anesth Pain Med. 2010 Mar-Apr;35(2):200-2. doi: 10.1097/aap.0b013e3181c7733d.