louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03017664: Improvement Project To Optimizing Nutrition With Higher Protein and Calorie Pediatric Tube Feeding
Official title: An Improvement Project Towards Optimizing Nutrition Intervention With a Higher Protein and Calorie Pediatric Tube Feeding Formula
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Critically Ill Children
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2017-01-11
Enrollment: 28
Sex: ALL
Minimum age (years): 1
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children aged 1-13 years with enteral feeding access

Brief summary: This quality improvement project will include a practice change based on national guidelines for the nutritional management of PICU patients.

Detailed description: This quality improvement project will include a practice change based on national guidelines for the nutritional management of PICU patients. The primary aim of this quality improvement project is to better meet protein needs of ICU critically ill children

Eligibility criteria: Inclusion Criteria:

* Children aged 1-18 years old with enteral feeding access and anticipated to be fed for 5 days

Exclusion Criteria:

-

Primary outcomes:
measure: Enteral formula volume
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
measure: Protein modular
timeFrame: 5 days
measure: Enteral feeding interruptions
timeFrame: 5 days
measure: Diarrhea
timeFrame: 5 days
measure: Vomiting
timeFrame: 5 days
measure: Elevated gastric residuals
timeFrame: 5 days
measure: Abdominal distention/pain
timeFrame: 5 days
Locations:
city: Chicago
country: United States
facility: The University of Chicago, Comer Children's Hospital
state: Illinois
city: Memphis
country: United States
facility: Le Bonheur Children's Hospital
state: Tennessee
Study officials:
affiliation: Société des Produits Nestlé (SPN)
name: Krysmaru B AraujoTorres, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02176564: Inhaled Bronchodilator Association and Quality of Life in Patients With Chronic Obstructive Pulmonary Disease
Official title: COPD, Inhaled Bronchodilators Association, and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-27
Enrollment: 2639
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with COPD

Brief summary: A pharmaco-epidemiological, observational study that aimed at assessing in a prospective manner the evolution of Quality of Life (QOL) in chronic obstructive pulmonary disease (COPD) patients treated with inhaled bronchodilators


Eligibility criteria: Inclusion Criteria:

* Diagnosis of COPD confirmed by Pulmonary Function Test (PFTs)
* Recent treatment with a free or fixed association of inhaled bronchodilators

Primary outcomes:
measure: Assessment of health-related quality of life (Short-Form Health Survey)
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05202964: Compliance and Tolerance to Oral AntiBiotherapy in Osteoarticular Infections (OTABIO)
Official title: Compliance and Tolerance to Oral AntiBiotherapy in Osteoarticular Infections
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Drug-Related Side Effects and Adverse Reactions
Treatment Adherence and Compliance
Keywords: Tolerance
Adherence
Antibiotic
BJI
adverse effect
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients having a BJI treated by at least one oral antibiotic after a surgery

Brief summary: Bone and joint infections (BJI) are most often bacterial infections that can occur after surgery or de novo. They are rarely fatal in the short term, but are associated with significant morbidity, impaired quality of life and significant costs. Treatment of BJI is based on antibiotic therapy, often combined with surgery. Antibiotic therapy, at high doses, lasts a minimum of 6 weeks. It can be responsible for severe adverse effects. These characteristics (prolonged duration, multiple daily doses, and adverse effects) are known to negatively affect treatment adherence in general.


Eligibility criteria: Inclusion Criteria:

* ≥ 18 years
* Diagnosis of osteoarticular infection
* Treatment with at least one oral antibiotic for a minimum expected duration ≥ 6 weeks with an expected end of treatment date
* Patient who was informed and did not object to participate in the study

Exclusion Criteria:

* Treatment for BJI with oral antibiotic without end of treatment date
* treatment for BJI with parenteral antibiotic only
* patient who doesn't have a telephone number or who doesn't want to give it
* Adults subject to a legal protection measure
* Pregnant or breastfeeding women

Primary outcomes:
measure: Percentage of doses taken at 6 weeks
timeFrame: At 6 weeks after surgery
measure: Percentage of doses taken at 3 months
timeFrame: at 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Valérie MIRABET
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00824564: Study Of Tranexamic Acid For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture
Official title: Prospective Randomized Phase IV Open Label Comparative Study Of Tranexamic Acid Plus Standard Of Care Versus Standard Of Care For The Reduction Of Blood Loss In Patients Undergoing Surgery For Long Bone Fracture
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Femoral Fractures
Keywords: Tranexamic Acid
Blood Loss
Long Bone Fracture Surgery
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-16
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Tranexamic acid has been shown to reduce postoperative blood losses and transfusion requirements in a number of types of surgery. Most trials in orthopedic surgery have been conducted in arthroplasty, hip fracture and spine surgeries. This study would aim to see the effect of tranexamic acid in reduction of blood loss and transfusions for long bone fracture surgery, primarily fracture shaft of femur.


Eligibility criteria: Inclusion Criteria:

* Patient undergoing surgery for fracture shaft of femur

Exclusion Criteria:

* Patients with a platelet count less than 100, 000/mm3 or history of thrombocytopenia
* Patients with known coagulopathy
* Patients with anemia (hemoglobin levels less than 8 mg/dl or hematocrit \<24%)
* Patients with documented DVT or PE at screening or in past three months
* Patients having known hypersensitivity to tranexamic acid or any other constituent of the product
* Patients with any associated major illness (e.g., severe cardiac or respiratory disease)
* Anticoagulants (other than LMWH or heparin in prophylactic doses to prevent deep vein thrombosis), direct thrombin inhibitors or thrombolytic therapy administered or completed within last week

Primary outcomes:
measure: Total Blood Loss
timeFrame: Baseline through Day 7 post-surgery
Secondary outcomes:
measure: Intra-operative Blood Loss
timeFrame: Day 1 (End of surgery)
measure: Post-operative Blood Loss
timeFrame: 1, 4, 8 and 24 hours post-surgery
measure: Total Blood Loss Assessed by Gross' Formula
timeFrame: Day 7 post-surgery
measure: Number of Participants Receiving Transfusions
timeFrame: Up to day 7 post-surgery
measure: Change From Baseline in Hemoglobin Levels at End of Surgery, 1 hr Post-surgery, and Mornings of Day 1, Day 2, Day 4, Day 7 or Early Termination (ET) Post-surgery
timeFrame: Baseline through end of surgery, 1 hr post-surgery, and mornings of Day 1, Day 2, Day 4, Day 7 or ET post-surgery
measure: Number of Participants With Deep Vein Thrombosis (DVT) Post Surgery
timeFrame: Day 5 post-surgery
Other outcomes:
Locations:
city: Coimbatore
country: India
facility: Pfizer Investigational Site
state: Tamil Nadu
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02539264: Impact of Smoking, Benzodiazepine (BZD) Use and Obesity on Severe Obstructive Sleep Apnea (sOSA)
Official title: Impact of Smoking, BZD and Obesity on Severe Obstructive Sleep Apnea (sOSA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Obesity
Smoking
Keywords: All patients registered for A PSG
polysomnography
Lead sponsor: Astes
Sponsor class: OTHER
First posted: 2015-09-03
Enrollment: 920
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: All patients registered for an overnight PSG at Clinique Saint-Luc of Bouge

Brief summary: In this study the investigators will analyze the influence of smoking, benzodizepine use, and obesity among patients with severe Obstructive Sleep Apnea (sOSA).

Detailed description: This study is a retrospective study. Patients enrolled: all patients with a PSG (polysomnography) between 1st January 2014 and 30th June 2015.

First analysis: influence of smoking, benzodiazepine use, and obesity on the AHI (Apnea Hypopnea Index: the number of apnea and hypopnea per hour of sleep).

Second analysis: only among patients with sOSA: influence of smoking, benzodiazepine use, and obesity on sleep fragmentation and night oximetry.

Eligibility criteria: Inclusion Criteria:

* All patients registered for an overnight PSG at Clinique Saint-Luc of Bouge

Exclusion Criteria:

* None

Primary outcomes:
measure: Apnea Hypopnea Index
timeFrame: 1 day
Secondary outcomes:
measure: Sleep fragmentation defined by the percentage of time spent in each of the four stades of sleep (Stade 1, Stade 2, Slow wave sleep and Rapid Eye Movements)
timeFrame: 1 day
measure: Time spent under 90% of SpO2 during the night
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Astes
name: Eric DEFLANDRE, MD, FCCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02580864: Bologna IBD Markers
Official title: Predictive Factors of Anti-TNFalfa-induced Deep Remission in Crohn's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn's Disease
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2015-10-20
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 120 adult patients with moderate-severe active Crohns disease with indication for anti-TNF therapy according to the normal clinical practice

30 no-IBD controls with no GI disorders, as defined by medical history and standard clinical chemistry values, afferent to the out-patient clinic

Brief summary: Individuate possible predictive factors of anti-TNFalfa-induced deep remission in Crohn's disease.

Detailed description: This trial will be exploratory, open in vitro study on human tissues. 120 patients will be enrolled (Caucasian, male/female,18-65 years old) with moderate-severe active Crohns disease and with indication for anti-TNF therapy according to the normal clinical practice.

Simultaneously, 30 no-IBD controls with no GI disorders, as defined by medical history and standard clinical chemistry values, afferent to the out-patient clinic will be enrolled.

Eligibility criteria: Main Inclusion Criteria for IBD patients:

* Adult patients (Caucasian)
* Moderate-severe active Crohns disease (220≤ CDAI ≤450; blood CRP ≥5 mg/L and/or fecal calprotectin ≥250mg/L)
* Indication for anti-TNF therapy according to the normal clinical practice
* Informed consent signed

Main Exclusion Criteria for IBD patients:

* Changes of Crohns disease treatment gastrointestinal medication (including corticosteroids) within the previous 2 weeks prior to enrollment
* Pregnant or breast-feeding (at index date) female patients

Main Inclusion Criteria for no-IBD controls:

* No-IBD adult controls (Caucasian) with no GI disorders, as defined by medical history and standard clinical chemistry values, afferent to the out-patient clinic
* Informed consent signed

Main Exclusion criteria for no-IBD controls:

* Medical history of digestive diseases
* Digestive, renal or metabolic disease, as determined by the medical visit and sa blood chemistry analysis

Primary outcomes:
measure: Number of IBD patients in clinical remission at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Number of IBD patients requiring an escalation treatment to be in clinical remission at 12 months
timeFrame: Baseline vs Baseline + 12 months
measure: Assess phenotypic traits between IBD patients in clinical remission at 12 months and non-IBD subjects
timeFrame: Baseline vs Baseline + 12 months
measure: Assess healthy intra-individual variability of gut microbial activity and dietary behavior in relation to disease development and management
timeFrame: Baseline
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Bologna University
Study officials:
References:
Clinical trial NCT03269864: Use of Perforator Flaps for Leg and Foot Reconstruction
Official title: Use of Perforator Flaps for Leg and Foot Reconstruction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Traumatic Skin Defect in Leg and Foot
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-09-01
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two arms, one will be managed by pedicled perforator flaps the other will be managed by free perforator flaps
Primary purpose: TREATMENT

Brief summary: Perforator vessels are those where the source artery is deep and the branch that carries blood to the fasciocutaneous tissues passes through the overlying deep fascia.

Soft tissue defects in the lower extremity, especially distal third of leg, present a challenge to reconstructive surgeons due to lack of reliable local flaps, conventional reconstructive options include split skin grafting, local random fasciocutaneous flaps, cross leg fasciocutaneous flap, pedicled muscular or musculocutaneous flaps or microvascular free tissue transfer. All these procedures have their limitations and associated morbidity at donor site

Detailed description: Taylor and Palmer defined an angiosome as a three-dimensional vascular territory supplied by a source artery and vein through branches for all tissue layers between the skin and the bone, and showed that between neighboring angiosomes there are choked and true anastomotic arteries.

Koshima and Soeda in 1989, described an inferior epigastric artery skin flap without the rectus abdominis muscle for reconstruction of floor of mouth, began the era of perforator flaps.

The big popularity gained by the local perforator flaps was due to their main advantages: 1) Sparing of the source artery and underlying muscle and fascia, 2) Combining the very good blood supply of a musculocutaneous flap with the reduced donor-site morbidity of a skin flap, 3) Replacing like with like, 4) Limiting the donor-site to the same area, 5) Possibility of completely or partially primarily closure, 6) Technically less demanding, because they are microsurgical procedures, but without microvascular sutures, 7) Shorter operating time.

Eligibility criteria: Inclusion Criteria:

1. Traumatic soft tissue defects on foot and leg.
2. Simple defects i.e., soft tissue loss, with or without, tendon injury.
3. Patients from 6 years to 60 years old

Exclusion Criteria:

1. Other causes of soft tissue defects e.g. (Diabetic, Vascular, post malignant resection).
2. Complex defects (soft tissue with bone injury).
3. Patients below 6 years or above 60 years old.
4. Patients with debilitating diseases e.g chronic renal failure, diabetes mellitus....etc.

Primary outcomes:
measure: Assessment of the perforator flap
timeFrame: This will be assessed in the first week postoperative
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02924064: Efficacy and Safety of Teneligliptin in Combination With Metformin in Chinese Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2016-10-05
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed as a prospective, multi-centre, parallel group, double-blind randomized, placebo-controlled, phase 3 clinical study to evaluate the efficacy and safety of MP-513 (Teneligliptin) in combination with metformin.


Eligibility criteria: Inclusion Criteria:

* A signed and dated informed consent form obtained from the subject, in accordance.
* The subject is aged ≥18 years at signature of the informed consent form.
* Hospitalization status: outpatient.
* The subject has a documented diagnosis of type 2 diabetes mellitus for at least 3 months at the screening visit (Day -28).
* The subject's type 2 diabetes mellitus is managed by metformin monotherapy ≥1000 mg/day plus diet and exercise therapy, and the dosage or dose regimen of metformin and diet and exercise regimen has not been changed for at least 8 consecutive weeks at the screening visit (Day -28). Subjects who cannot do exercise due to complication are not limited to this criteria.
* The subject's HbA1c is ≥ 7.0% and \< 10.0% at the screening visit (Day -28) and on Day -14.

Exclusion Criteria:

* The subject has a history of type 1 diabetes mellitus or a secondary form of diabetes.
* The subject has received insulin within 1 year prior to the screening visit (Day -28), with the exception of insulin therapy during hospitalization or insulin therapy for medical conditions not requiring hospitalization (\< 2 weeks' duration).
* The subject has received an anti-diabetic drug within 8 weeks prior to the screening visit (Day -28).

Primary outcomes:
measure: The Changes in HbA1c at Week 24
timeFrame: at Day 1(baseline) and Week 24
Secondary outcomes:
measure: The Changes in Fasting Plasma Glucose (FPG) at Week 24
timeFrame: at Day 1(baseline) and Week 24
Other outcomes:
Locations:
city: Beijing
country: China
facility: Investigational center
Study officials:
affiliation: Mitsubishi Tanabe Pharma Corporation
name: General Manager
role: STUDY_DIRECTOR
References:
Clinical trial NCT00769964: VA111913 TS: First in Human Study
Official title: A First in Human Study Consisting of a Two-Part, Double-Blind, Placebo-Controlled, Escalating Single and Multiple Dose Study of VA111913 TS in Adult Non-Pregnant Women Volunteers With a Single Dose, Open, Fed vs. Fasting Crossover Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dysmenorrhea
Keywords: Healthy (Dysmenorrhea)
Lead sponsor: Vantia Ltd
Sponsor class: INDUSTRY
First posted: 2008-10-09
Enrollment: 98
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: TREATMENT

Brief summary: This is a first-in-human study of VA111913 TS, a new chemical entity being developed for the treatment of dysmenorrhea. This study is designed to investigate determine the safety, tolerability and pharmacokinetics of VA111913 TS after single and multiple doses in healthy non-pregnant female volunteers of child bearing age.

Detailed description: VA111913 TS is a selective V1a-receptor antagonist. The hypothesised mechanism of action of a V1a receptor antagonist in dysmenorrhea has been described in literature. Contractions of the uterine muscle are required for normal menstruation. Women with dysmenorrhea have increased uterine myometrial tone and contractions and decreased blood flow to the uterus. These abnormalities have been shown to lead to the pain experienced in dysmenorrhea. Thus, if a drug is able to reduce the hyperreactivity of the uterus to physiological levels then the pain experienced in dysmenorrhea may be controlled. In humans, vasopressin, via the V1a receptor, is able to potently induce contractions in both uterine smooth muscle and uterine blood vessels. Thus, a V1a receptor antagonist will potentially inhibit these contractions and in turn reduce the pain experienced in dysmenorrhea.

Eligibility criteria: Inclusion Criteria:

* Healthy females 18 to 45 years of age.
* Subjects must have a negative pregnancy test at screening and admission. Using acceptable form of contraceptive during and after study.

Exclusion Criteria:

* Administration of any IMP within 12 weeks before entry to the study or any prescribed medicine within 14days of the study.
* Any clinically important medical disease, condition or abnormal laboratory test results.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Charles River Clinical Services
Study officials:
References: