louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05264402: Comparison of Early Phase Infections Risk Between Midline and Piccline Caheters: MIDLINE AND PICCLINE CATHETERS
Official title: Comparison of Early Phase Infections Risk Between Midline and Piccline Caheters: MIDLINE AND PICCLINE CATHETERS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Catheter-related Bloodstream Infection
Keywords: venous access
Midline
PICC line
catheter-related bloodstream infections
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2022-03-03
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring a vascular approach using PICCline or Midline catheters

Brief summary: A long-term venous access is frequently required in patient management. Currently, it is ensured by using the long peripheral intravenous catheters (Midline) or peripheral inserted central catheters (PICC line). Either is inserted into a peripheral vein of the upper arm and extends to the distal axillary vein.

If the indications for the two catheters can sometimes be debated, the Midline catheter seems to be more and more used. The complications related to the use of PICC lines have been well described in literature, whereas the comparison of the two catheter-related complications has been less analysed.

The aim of this study is to compare the incidences of catheter-related bloodstream infections linked to PICCs and Midlines.

Detailed description: This single-center observational study will record and compare Midline and PICC line catheter-related bloodstream infections in the first 30 days after placement, catheter-related bloodstream infections being defined as clinical signs associated with a positive catheter culture (bacterial culture finding more than 103 CFU/mL) without any other infectious entry points.

Catheter indications, insertion conditions, incidence of haemorrhagic and thrombotic complications during the first 30 days will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Major ≥ 18 years old
* opposition formulated

Exclusion Criteria:

* Refusal of participation
* Patients under legal protection (guardianship, curatorship, etc.)

Primary outcomes:
measure: Compared rate of catheter-related bloodstream infections in the first 30 days in Midline and PICCline group. Catheter-related bloodstream infections are defined as clinical signs with a positive catheter culture without any other infectious entry points.
timeFrame: first 30 days after placement
Secondary outcomes:
measure: catheter placement time will be evaluated in days
timeFrame: first 30 days after placement
measure: rate of no infection complications like obstruction, accidental removal, thrombosis, hemorrhagic complications
timeFrame: first 30 days
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
Clinical trial NCT00351221: Research Study Using Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 for Children With Noonan Syndrome
Official title: A Phase 2, Open-Label, Multicenter, Clinical Trial to Evaluate the Pharmacokinetics, Safety and Efficacy of Recombinant Human Insulin-Like Growth Factor-1/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 in Children With Growth Failure Due to Noonan Syndrome
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Noonan Syndrome
Lead sponsor: Insmed Incorporated
Sponsor class: INDUSTRY
First posted: 2006-07-12
Enrollment: 24
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The trial will investigate the treatment of growth failure in children with Noonan syndrome. Abnormalities in the growth hormone (GH) - insulin-like growth factor-I (IGF-I) axis resulting in low IGF-I levels have been suggested as a possible cause of short stature seen in Noonan syndrome children. Administration of our investigational product is intended to bypass the abnormalities in the GH-IGF axis, and hopefully improve body growth.


Eligibility criteria: Inclusion Criteria:

1. A diagnosis of Noonan syndrome
2. Height less than the 3rd percentile for age and sex (height SDS \< -1.88)
3. Basal IGF-I less than the mean for age and sex (IGF-I SDS \< 0)
4. Chronological age greater than 2 years
5. Bone age ≤ 11 years for boys, and ≤ 10 years for girls
6. Pre-pubertal
7. Documented pre-treatment height velocity less than the mean for age and sex

Exclusion Criteria:

1. Clinically significant diseases
2. Chronic illnesses
3. Prior treatment with rhIGF-1

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Hyde Park
country: United States
facility: Schneider Children's Hospital
state: New York
city: Columbus
country: United States
facility: Columbus Children's Hospital
state: Ohio
Study officials:
affiliation: Insmed, Inc.
name: Kenneth Attie, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06062121: Pilot Study of Motor-cable-driven System for Stroke Wrist and Forearm Rehabilitation
Official title: Pilot Study of Motor-cable-driven System for Stroke Wrist and Forearm Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-10-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The research purpose is to investigate the feasibility of using a motor-cable-driven system for wrist and forearm recovery of hemiplegic subjects suffered from stroke, where assistive force would be generated from cables connected to pulleys and electrical motors. The system may use EMG signal to control the movements.


Eligibility criteria: Inclusion Criteria:

* Sub-acute and chronic stroke patients (ischemic or hemorrhagic).
* Sufficient cognition to follow simple instructions as well as understand the content and purpose of the study.

Exclusion criteria:

1. Patients with severe dysphasia (either expressive or comprehensive) with inadequate communication.
2. Any additional medical or psychological condition affecting their ability to comply with the study protocol.

Primary outcomes:
measure: Forearm's Assisted Range of Motion
timeFrame: Baseline
measure: Wrist's Assisted Range of Motion
timeFrame: Baseline
Secondary outcomes:
measure: Upper limb Fugl-Meyer Assessment (FMA)
timeFrame: Baseline
measure: Motor Assessment Scale (MAS)
timeFrame: Baseline
measure: Modified Ashworth Scale
timeFrame: Baseline
measure: Forearm's Active Range of Movement
timeFrame: Baseline
measure: Forearm's Passive Range of Motion
timeFrame: Baseline
measure: Wrist's active range of motion
timeFrame: Baseline
measure: Wrist's Passive Range of Motion
timeFrame: Baseline
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Biomedical Engineering, The Chinese University of Hong Kong
Study officials:
affiliation: Department of Biomedical Engineering, The Chinese University of Hong Kong
name: Raymond Kai-yu Tong
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04812821: Statement of Care of Anemia in Delivering Patients at Nord Franche-Comte Hospital
Official title: Statement of Care of Anemia in Delivering Patients at Nord Franche-Comte Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Anemia
Lead sponsor: Hopital Nord Franche-Comte
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 1177
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting eligibility criteria and giving birth at NFC Hospital

Brief summary: Anemia is a common pregnancy condition that has multiple origins. Its frequency and severity seem to be increasing, despite the existing management recommendations and the awareness of health professionals. The objective of this study is to make a statement of this pathology within our establishment, to evaluate the proportion of patients presenting this pathology and to highlight possible risk factors.


Eligibility criteria: Inclusion Criteria:

* \> 18 years
* Delivery at Nord Franche-Comte Hospital
* Delivery ≥ 32 weeks of amenorrhea
* Informed patient and non-opposition of participation

Exclusion Criteria:

* Protected adults (Patients under guardianship, curatorship, safeguard of justice or under family authorization)
* Medical interruption of pregnancy
* Patients with fetal death in utero or neonatal death
* Minor patients
* Premature delivery before 32 weeks

Primary outcomes:
measure: Estimation of the proportion of patients presenting anemia during delivery
timeFrame: 6 month
Secondary outcomes:
measure: Risk factors underlying anemia during delivery with a large questionnaire
timeFrame: 6 month
Other outcomes:
Locations:
city: Trévenans
country: France
facility: Hôpital Nord Franche-Comté
Study officials:
References:
Clinical trial NCT03783221: Effect of Previous Diet
Official title: Factors That Determine the Responses to Meal Ingestion: Effect of Previous Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: meal ingestion
diet
postprandial responses
hedonic sensations
homeostatic sensations
intestinal gas production
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Meal ingestion induces digestive responses associated to homeostatic and hedonic sensations. The responses to meal ingestion are modulated by conditioning factors. Single-centre, cross-over, random, open label study comparing the effect of a high-fat/low-residue diet versus low-fat/high residue diet on the responses to meal ingestion. In 20 healthy subjects each diet will be administered during 2 weeks in random order; each diet will be preceded by 2 weeks washout, balanced diet. The aim of the study is to compare the effects of each diet on the responses to comfort and flatulogenic meals, intestinal gas production and digestive sensations.


Eligibility criteria: Inclusion Criteria:

* non-obese

Exclusion Criteria:

* history of gastrointestinal symptoms
* prior obesity
* use of medications
* history of anosmia and ageusia
* current dieting
* alcohol abuse
* psychological disorders
* eating disorders

Primary outcomes:
measure: Change in digestive well-being induced by comfort meal
timeFrame: 1 day
Secondary outcomes:
measure: Change in fullness sensation induced by comfort meal
timeFrame: 1 day
measure: Change in mood induced by comfort meal
timeFrame: 1 day
measure: Change in hunger/satiety induced by comfort meal
timeFrame: 1 day
measure: Intestinal gas evacuation in response to a flatulogenic meal.
timeFrame: 1 day
measure: Intestinal gas production
timeFrame: 2 days
measure: Sensation of flatulence
timeFrame: 2 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: University Hospital Vall d'Hebron
Study officials:
References:
citation: Pribic T, Azpiroz F. Biogastronomy: Factors that determine the biological response to meal ingestion. Neurogastroenterol Motil. 2018 Jul;30(7):e13309. doi: 10.1111/nmo.13309. Epub 2018 Feb 2.
Clinical trial NCT05878821: Effect of Shockwave Therapy on Cervical Myofascial Syndrome in Lactating Women
Official title: Effect of Shockwave Therapy on Cervical Myofascial Pain Syndrome in Lactating Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Myofascial Pain Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 30
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups,one group will be treated by shockwave therapy and postural correction exercise and other group will be treated by postural correction exercise
Primary purpose: TREATMENT

Brief summary: the aim of the study is to determine the effect of shockwave therapy on cervical myofascial pain syndrome in lactating women

Detailed description: Neck and shoulder pain was 73,1%,one fourth of which occurred after birth.the most common area was the superior part of the trapezius.the symptoms of patients are pain, stiffness and limited range of motion (ROM).

Eligibility criteria: Inclusion Criteria:

* Multipara two months after labor.
* number of parity not more than 3.
* age range 25_35.BMI less than 35 Kg/m2

Exclusion Criteria:

* Diabetic women
* Women with malignancy
* Neck pain from other conditions such as(spinal
* instability, spinal fracture, spinal cord compression,inflammatory disease, spinal infection, congenital postural deformity

Primary outcomes:
measure: Visual analogue scale
timeFrame: 4 weeks
measure: Pressure Algometer
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of physical therapy
Study officials:
References:
Clinical trial NCT00625521: Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions
Official title: Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Patients With Newly Developed Discoid Lupus Erythematosus (DLE) Lesions. An International Multi-Centre Clinical Phase 2, Placebo Controlled and Double Blind Proof of Concept Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Discoid Lupus Erythematosus
Keywords: Discoid lupus erythematosus
Lead sponsor: Astion Pharma A/S
Sponsor class: INDUSTRY
First posted: 2008-02-28
Enrollment: 32
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: Lupus Erythematosus (LE) is an autoimmune disorder that includes a broad spectrum of clinical forms. One of these forms, Discoid Lupus Erythematosus (DLE) is a chronic disfiguring disease confined to the skin.

The aim of this pivotal trial is to investigate the efficacy and safety of ASF-1096 cream 0.5% in the treatment of patients with DLE or SLE presenting newly developed discoid lesions.


Eligibility criteria: Inclusion Criteria:

* A clinical diagnosis of either DLE or SLE
* Histological results from biopsy confirming the diagnosis (biopsy can be taken at screening)
* Is prepared to grant authorised persons access to the medical records
* Has signed informed consent

Exclusion Criteria:

* Has an active skin disease other than DLE or another progressive or serious disease that interferes with the study outcome
* Has scarring at the target lesion
* Systemic treatment of SLE

Primary outcomes:
measure: Safety profile, CLASI score, GIA and GPA.
Secondary outcomes:
Other outcomes:
Locations:
city: Danderyd Stockholm
country: Sweden
facility: Filippa Nyberg
Study officials:
References:
Clinical trial NCT02959021: Partnership Optimizes Weight Management in Primary Care
Official title: Primary Care Obesity Management in the Southeast_PROMISE
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Obesity
Keywords: weight loss
behavioral
primary care
lifestyle
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2016-11-08
Enrollment: 375
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
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 examine whether a primary care weight management intervention delivered by peer coaches produces greater weight loss than a self-directed program without peer coach support.


Eligibility criteria: Inclusion Criteria:

* Age 21-75 years
* Body mass index (BMI) 30-50 kg/m2
* Receiving primary care services at one of the practices participating in this study

Exclusion Criteria:

* Uncontrolled hypertension (blood pressure \>160/100 mm Hg at screening)
* Any of the following other medical conditions: myocardial infarction or cerebrovascular accident within the last six months; unstable angina within the past six months; NYHA Class III or IV congestive heart failure; type 1 diabetes; cancer requiring treatment in past five years (exception: non-melanoma skin cancer); and chronic lung diseases that limit physical activity
* Current use of any of the following medications: antipsychotic agents, monoamine oxidase inhibitors, systemic corticosteroids, or chemotherapeutic drugs; prescription weight loss medications (past six months)
* Unwilling or unable to do any of the following: give informed consent; read/understand English; accept random assignment; travel to the intervention site
* Likely to relocate out of the area in the next 2 years
* Participation in another randomized research project
* Weight loss \> 10 pounds in past six months
* History of bariatric surgery

Primary outcomes:
measure: body weight
timeFrame: 6, 12, and 18 months
Secondary outcomes:
measure: physical activity
timeFrame: 6, 12, and 18 months
measure: treatment adherence
timeFrame: 6, 12, and 18 months
measure: treatment burden
timeFrame: 6, 12, and 18 months
measure: treatment satisfaction
timeFrame: 6, 12, and 18 months
measure: side effects
timeFrame: 6, 12, and 18 months
measure: quality of life
timeFrame: 6, 12, and 18 months
measure: physical and social functioning
timeFrame: 6, 12, and 18 months
measure: mood
timeFrame: 6, 12, and 18 months
measure: healthcare utilization
timeFrame: 6, 12, and 18 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Gareth Dutton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01634321: The Clinical Trial to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide Acetate 3.75mg) in Patients With Precocious Puberty
Official title: The Phase 4 Clinical Trial to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide Acetate 3.75mg) in Patients With Precocious Puberty; A Single, Open, Multi-center, Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Central Precocious Puberty
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2012-07-06
Enrollment: 63
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this Clinical Trial was to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide acetate 3.75mg) in patients with precocious puberty.


Eligibility criteria: Inclusion Criteria:

* 4\~8 years \& tanner stage ≥ 2

Exclusion Criteria:

* Previous treatment with GnRH analog therapy

Primary outcomes:
measure: At 24 weeks, percentage of subjects with suppression of peak-stimulated Luteinizing Hormone (LH) concentrations
timeFrame: At 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Soo-won
country: Korea, Republic of
facility: Ajou University medical center
Study officials:
References:
Clinical trial NCT05241821: Acute STROke Complicating TAVI - Management and Outcomes
Official title: Management and Outcomes of Acute STROke Complicating Transcatheter Aortic Valve Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Aortic Valve Stenosis
Periprocedural Complication
Keywords: periprocedural stroke
transcatheter aortic valve implantation
transcatheter aortic valve replacement
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 484
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with periprocedural stroke complicating TAVI

Brief summary: Periprocedural complications of trans catheter aortic valve implantation, and particularly the occurrence of stroke has a marked impact on survival and quality of life. The characteristics of periprocedural stroke complicating TAVI, and particularly of interventions aimed to treat stroke complicating TAVI have not been systematically described. We therefore aimed is to explore the incidence and characteristics of acute stroke complicating TAVI and to describe the safety and efficacy of emergent interventions to treat acute stroke complicating TAVI.


Eligibility criteria: Inclusion Criteria:

* patients who have had a stroke within 30 days of TAVI

Exclusion Criteria:

* none

Primary outcomes:
measure: All cause mortality
timeFrame: 1-year
measure: Neurologic disability free survival
timeFrame: 90 days
Secondary outcomes:
measure: Bleeding complications
timeFrame: 30 days
Other outcomes:
Locations:
city: Petah tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Head of cardiology
name: Ran Kornowski, MD
role: PRINCIPAL_INVESTIGATOR
References: