louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05057351: A Controlled Study to Evaluate the Efficacy and the Tolerability of a Cosmetic Active Ingredient Intended for Subjects With Atopic Dermatitis
Official title: Randomized, Double Blind, Clinical Study for Evaluating the Efficacy and the Tolerability of a Cosmetic Active Ingredient Intended for Subjects With Atopic Dermatitis. Controlled Study vs Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild to Moderate Atopic Dermatitis
Lead sponsor: Greenpharma S.A.S.
Sponsor class: OTHER
Collaborators: name: Complife Italia S.r.l
First posted: 2021-09-27
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center, randomized, double-blind, placebo-controlled, parallel group study, carried on 2 groups of 22 subjects.
Primary purpose: TREATMENT

Brief summary: Evaluation of safety and clinical efficacy of an active ingredient versus placebo for the treatment of mild to moderate Atopic Dermatitis (AD) adults.


Eligibility criteria: Main Inclusion Criteria:

* Good general health
* Phototype I to IV
* Mild to moderate SCORAD (between 15 and 25)

Main Exclusion Criteria:

* Pregnant/breastfeeding female or who have planned a pregnancy during the study period
* Positive history for atopy or hypersensitive skin
* Subjects under systemically pharmacological treatment
* Subjects under locally pharmacological treatment on the skin area monitored during the test
* Subjects with congenital or acquired immunodeficiency
* Subjects under treatment with food supplements which could interfere with the functionality of the product under study
* Subjects which show other skin alterations on the monitored area except for acne lesions
* Subjects with known or suspected sensitization to one or more test formulation ingredients

Primary outcomes:
measure: Change in severity of Atopic Dermatitis as assessed using the SCORing Atopic Dermatitis (SCORAD)
timeFrame: 7, 14 and 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: San Martino Siccomario
country: Italy
facility: Complife Italia S.r.l.
Study officials:
affiliation: Complife Italia S.r.l
name: Gloria Roveda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04307251: Comparative Outcomes Between Imageless Robotic-assisted and Conventional Total Knee Arthroplasty
Official title: Comparative Outcomes Between Imageless Robotic-assisted and Conventional Total Knee Arthroplasty : A Prospective, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis, Knee
Lead sponsor: Navamindradhiraj University
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 168
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare post-operative mechanical alignment (Hip-Knee-Ankle angle; HKA) between imageless robotic-assisted (Navio™ Robotics-assisted Surgical System) and Conventional Total Knee Arthroplasty


Eligibility criteria: Inclusion Criteria:

* Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty
* Age 50-80 year
* Patients with osteoarthritis who voluntarily participated in the project

Exclusion Criteria:

* Patients with osteoporosis
* History of inflammatory arthroplathy
* Previous fracture or open surgery on the same knee
* Patients with bilateral total knee arthroplasty
* Patients osteoarthritis with revision surgery

Primary outcomes:
measure: Mechanical axis
timeFrame: Change from baseline mechanical axis at 6 weeks after surgery
Secondary outcomes:
measure: Knee Society and Knee Society function score
timeFrame: Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery
measure: Range of motion of knee
timeFrame: Change from baseline Range of motion of knee at 3 months, 6 months, and 12 months after surgery
measure: Oxford knee score
timeFrame: Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery
Other outcomes:
Locations:
city: Dusit
country: Thailand
facility: Navamindradhiraj University
state: Bangkok
Study officials:
affiliation: Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
name: Satit Thiengwittayaporn, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01739751: Physical Activity Enhancement Using Pedometers in COPD
Official title: Effect of a Program of Physical Activity Enhancement Using Pedometers in Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Keywords: COPD
Physical activity
Pedometers
steps
non pharmacological treatment
rehabilitation
exercise
Lead sponsor: University of Chile
Sponsor class: OTHER
Collaborators: name: Comisión Nacional de Investigación Científica y Tecnológica
First posted: 2012-12-03
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Physical activity is reduced in COPD affecting morbidity and mortality and the usual advice is not good enough to increase the physical activity level. The aim of the study is to determine the effects of pedometers in the physical level in COPD patients.

Detailed description: Physical activity is reduced in COPD patients and has a negative effect in the morbidity and mortality of this condition. Unfortunately, usual advice is not good enough to reverse the sedentary condition in COPD patients. Pedometers are broadly used to measure and to enhance physical activity in COPD but their effects in COPD are not well known. The aim of the study is to determine the effects of a program using pedometers as a feedback in stable ex smokers COPD patients. Patients are recruited for a 3 months individual program promoting daily physical activity enhancement and are randomly assigned either to a pedometer-based program (experimental group) or to usual care (control group, the measurements at the beginning and at the end of the study are: anthropometrics, Spirometry, dyspnea, quality of life, exercise capacity and the average one week daily steps. Also the number of acute exacerbations during the follow up are recorded.

Eligibility criteria: Inclusion Criteria:

* COPD diagnosis according to GOLD guidelines
* Pack year Index equal or more than 10
* smoking suspended \> 2 months
* older than 40 years old,

Exclusion Criteria:

* any chronic condition that does not allow walking
* participation in a rehabilitation program
* Acute exacerbation in the last two months

Primary outcomes:
measure: effect in average steps walked daily
timeFrame: 3 months
Secondary outcomes:
measure: six minute walking distance
timeFrame: 3 months
measure: score in the Saint George Respiratory Questionnaire
timeFrame: 3 months
measure: Score of the COPD Assessment Test (CAT)
timeFrame: 3 months
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clínico Universidad de Chile
state: Región Metropolitana
Study officials:
affiliation: Hospital Clínico University of Chile
name: Laura Mendoza, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bravata DM, Smith-Spangler C, Sundaram V, Gienger AL, Lin N, Lewis R, Stave CD, Olkin I, Sirard JR. Using pedometers to increase physical activity and improve health: a systematic review. JAMA. 2007 Nov 21;298(19):2296-304. doi: 10.1001/jama.298.19.2296.
Clinical trial NCT04861051: Understanding Ketamine's Dissociative Effects (KD Study)
Official title: Understanding Ketamine's Dissociative Effects in Epilepsy (KD Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Epilepsy
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to understand how ketamine brings about dissociative symptoms.

Detailed description: The goal of this proposed research is to record the effects of ketamine on brain activity to understand the changes that occur during dissociation in epilepsy patients with stereoEEG.

Eligibility criteria: Inclusion Criteria:

* Patient in Stanford Epilepsy Monitoring Unit
* Age \>18 years old.

Exclusion Criteria:

* Lifetime psychotic or bipolar disorder
* Inability to speak, read or understand English
* Pregnant or nursing females
* Prior adverse ketamine response

Primary outcomes:
measure: Number of participants with dissociative events during ketamine infusion as assessed by CADSS (Clinician-Administered Dissociative State Scale)
timeFrame: up to 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Karl Deisseroth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04131751: Application of Clinical Metagenomics in the Diagnosis of Ascites
Official title: Establishing of Next Genaration Sequencing Methods for Microbiological Diagnostic of Ascitic Fluid Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ascites Infection
Keywords: Metagenomics
Lead sponsor: University Hospital Freiburg
Sponsor class: OTHER
First posted: 2019-10-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include adult consent intensive care patients who undergo parenthesis for diagnostic purposes to exclude ascitic infection, regardless of the clinical picture. The indication for puncture is provided by the attending clinician regardless of the study.

Brief summary: Infection of the ascitic fluid is a serious complication associated with high morbidity and mortality. This fluid is often colonized with bacteria that can cause infection of the peritoneum and possibly sepsis. Many bacteria of the human intestinal microbiome can't be cultured by standard methods; therefore it seems likely that many of the relevant bacteria are not discovered in routine diagnostics, but may be relevant to pathogenesis. Culture-independent approaches such as NGS (Next generation Sequencing) have in principle made it possible to study or prove complex microbial colonization. Because NGS is a relatively new technology, microbiological diagnostic protocols need to be further customized and refined to integrate with the standard diagnostic workflow, if necessary. For microbiological diagnostics, material is collected from the appropriate ascites patients and sent for microbiological diagnostics. Afterwards the cultural diagnostics are carried out as part of the patient care at the university hospital. In this study the investigators plan to use these samples to analyze and compare the presence of bacteria by NGS in parallel to the culture diagnostics, and then compare it to the patients' gut microbiome, to understand the possible effect of the microbiome on ascites pathogenesis and outcome.


Eligibility criteria: Inclusion Criteria:

* Male and female patients ≥ 18 years of age
* Samples from patients who have ascites puncture to exclude infection
* Written consent of the patient after clarification

Exclusion Criteria:

* Minor patients
* Non-consenting patients
* Samples without sufficient residual material after standard diagnostics
* Samples from patients who have not consented to the examination.

Primary outcomes:
measure: The comparative assessment of about 50 patients
timeFrame: 12-18 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Institute for Microbiology and Hygiene
state: Baden Württemberg
Study officials:
affiliation: Institute for Microbiology and Hygiene, Hermann-Herder-Str. 11, 79104 Freiburg
name: Mohamed Tarek Badr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03386851: Abilify Maintena PMS in Schizophrenia Patients or Bipolar 1 Disorder
Official title: Post-Marketing Surveillance of Safety and Effectiveness of Abilify Maintena® Injections in Korean Patients With Schizophrenia or Bipolar 1 Disorder Under the "New Drug Re-Examination"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Bipolar 1 Disorder
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-12-29
Enrollment: 1030
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Schizophrenia or bipolar 1 disorder

Brief summary: This is a Post-Marketing Surveillance (PMS) of Abilify Maintena® Injections in accordance with Korean regulations on New Drug Re-examination (i.e. New Drug Re-examination Standards: Ministry of Food and Drug Safety(MFDS) Notification).


Eligibility criteria: Inclusion Criteria:

* Adult patients with schizophrenia or bipolar 1 disorder
* Patients who are prescribed Abilify Maintena® Injections treatment as per investigator's medical judgment
* Patients giving written authorization to use their personal and health data and starting Abilify Maintena® Injections treatment after agreement is in place and investigators provide the explanation about objective and feature of the surveillance

Exclusion Criteria:

* Patients with known hypersensitivity to Aripiprazole or any excipients of Abilify Maintena® Injections
* Elderly patients with dementia related psychosis
* Patients who have been treated with Abilify Maintena® Injections
* Patients with score 0(Not assessed) or 1(Normal, not at all ill) in the Clinical Global Impression-Severity(CGI-S)
* Patients participating in other clinical trial
* All patients who in medical judgment of the investigator would not be appropriate for inclusion criteria in the surveillance

Primary outcomes:
measure: The incidence rate and the number of Adverse Events (AE)/ Adverse Drug Reactions (ADR), Serious AE/ADR, Unexpected AE/ADR
timeFrame: until 28 days after discontinuation
Secondary outcomes:
measure: Mean change from baseline to last visit in Clinical Global Impression - Severity of Illness scale (CGI-S) score.
timeFrame: at least 12, 24 weeks interval from baseline
measure: Clinical Global Impression - Improvement scale (CGI-I) score at the last visit
timeFrame: at least 12, 24 weeks interval from baseline
measure: Mean change from baseline to last visit inPersonal and Social Performance Scale (PSP) score.
timeFrame: at least 12, 24 weeks interval from baseline
measure: Overall judgement at last visit compared to baseline, judged holistically according to clinical symptoms: "Effective", "No effect", "Worsen"
timeFrame: at least 12, 24 weeks interval from baseline
Other outcomes:
Locations:
city: Gwangju
country: Korea, Republic of
facility: St.John of God Hospital
Study officials:
References:
Clinical trial NCT01120951: Clinical Assessment of the Use of the R8 Respiratory Rate Counter in Post-Operative Recovery in Adults and Adolescents
Official title: Clinical Assessment of the Use of the R8 Respiratory Rate Counter in Post-Operative Recovery in Adults and Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Rate Changes
Keywords: Respiratory rate R8 Anaxsys
Lead sponsor: Anaxsys Technology Ltd
Sponsor class: INDUSTRY
First posted: 2010-05-11
Enrollment: 220
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female patients aged 12 years and above following elective surgery under general anaesthesia

Brief summary: The study aims to to establish whether or not measurement of respiratory rate taken using the Anaxsys Technology Ltd Respiratory Counter (R8 Counter) are equivalent to manual respiratory rate counting methods in patients receiving oxygen via a face mask.


Eligibility criteria: Inclusion Criteria:

* Male or female patients aged 12 years and above following elective surgery under general anaesthesia

Exclusion Criteria:

* Patients admitted for emergency surgery
* Patients having ASA rating of 3 or greater
* Patients not receiving general anaesthesia
* Patients expected to be in post-operative recovery for less than 15 minutes

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Papworth Hospital NHS Foundation Trust
state: Cambridgeshire
city: Stoke-on-Trent
country: United Kingdom
facility: University Hospital of North Staffordshire
state: Staffordshire
city: Guildford
country: United Kingdom
facility: St. Peter's and Ashford Hospital NHS Trust
state: Surrey
city: Dudley
country: United Kingdom
facility: Russells Hall Hospital
state: West Midlands
Study officials:
References:
Clinical trial NCT01689051: Vasodilatory and Metabolic Effects of Glucagon-like Peptide-1 in Periphery Circulation in Patients With and Without Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Blod Pressure
Glucagon-like Peptide-1
Human Physiology
Blood Flow
Keywords: Type 2 diabetes
Blod pressure
Glucagon-like peptide-1
Human physiology
Blood flow
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
Collaborators: name: Danish Heart Foundation
First posted: 2012-09-20
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Diabetes and high blood pressure are risk factors for developing heart disease. An increase in the number of diabetes patients is expected. This increases the number of patients with heart disease, and since the vast majority with diabetes die from heart disease, it is extremely important to investigate how these diseases can be prevented and treated.

Studies in animals have shown that intestinal hormone glucagon-like peptide-1 (GLP-1) can expand blood vessels, thus lowering blood pressure, but it is not known whether the effects is found in humans, which we will investigate.

Studies have also shown that GLP-1 lowers blood sugar, but it is unclear whether this is solely due to increased insulin production, weight loss associated with GLP-1 intake or GLP-1 has an effect on the muscles which increases the uptake of sugar. We investigate whether GLP-1 enhances the absorption of sugar in the leg.

The investigators also examines whether these effects are greater in people with diabetes then in healthy.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* T2DM according to WHO's criteria (only T2DM subjects)

Exclusion Criteria:

* Anemia
* T1DM
* Severe liver or renal disease
* Severe heart disease
* Atrial fibrillation

Primary outcomes:
measure: Femoral artery blood flow
Secondary outcomes:
measure: Leg glucose uptake
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Gentofte Hospital, Department of Cardiology
Study officials:
affiliation: University Hospital, Gentofte, Copenhagen
name: Jacob C Sivertsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04380051: Evaluation of a Sensory-tonic Stimulation on Development of Parent-infant Interactions and Social Cognition in Very Premature Children
Official title: Evaluation of a Sensory-tonic Stimulation on Development of Parent-infant Interaction and Social Cognition in Very Premature Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Very Preterm Birth
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2020-05-08
Enrollment: 120
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: participants are assigned to one of two or more groups in parallel for the duration of the study
Primary purpose: TREATMENT

Brief summary: Attachment is built primarily on the first interactions of the first 9 months of a baby's life. These first interactions and their effects of stress, pleasure and displeasure are retained to establish some of the baby's attachment behaviours and future relationships with others.

Extreme prematurity strongly modify these first interactions between parents and child. Very preterm child is separated from his parents and is placed in a stressful, technical and potentially painful environment.

Early interventions stimulate neuroplasticity and can positively affect the neurological development of very preterm infant. Tactile stimuli such as skin-to-skin contact and massages carried out by parents can be pleasant experiences that can support early interactions between parents and child.

Detailed description: The aim of the study is to evaluate impact of a sensory-tonic stimulation on development of parent-infant interaction and on social cognition in very premature children.

Eligibility criteria: inclusion criteria :

* very preterm child (born before 32 weeks of amenorrhoea)
* parents agreeing to participate to the study

exclusion criteria :

* child born before 25 weeks of amenorrhoea
* child with a birth weight less than 600 grams
* child with congenital malformation
* child with hemodynamic instability

Primary outcomes:
measure: interactions between parents and child
timeFrame: 12 months
Secondary outcomes:
measure: Social cognition / Theory of mind
timeFrame: 6 years
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References:
Clinical trial NCT05400551: Craneofacial Injuries in Rink Hockey Athletes
Official title: Epidemiology of Craneofacial Injuries in Rink Hockey Athletes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head Injury
Face
Concussion, Brain
Keywords: rink hockey
injury
epidemiology
burden
Lead sponsor: University of Oviedo
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: athletes that compete in rink hockey, independently of their age or sex

Brief summary: To collect the number of injuries that affect the face and head in rink hockey athletes prospectively during a regular season.

Detailed description: To collect the number of injuries that affect the face and head in rink hockey athletes prospectively during a regular season, while collecting athlete´s exposure and specifical injury characteristics (Burden, mechanism, situation, etc)

Eligibility criteria: Inclusion Criteria:

* Compete in a spanish rink hockey league
* play at least in one game during ther regular season

Exclusion Criteria:

* do not accept the participation in the study

Primary outcomes:
measure: Number of participants injured
timeFrame: september 2022 to march 2023
measure: days lost due to injury
timeFrame: september 2022 to march 2023
Secondary outcomes:
measure: usage of helmet
timeFrame: september 2022 to march 2023
measure: situational characteristics of the injury
timeFrame: september 2022 to march 2023
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hugo Olmedillas
state: Asturias
city: Oviedo
country: Spain
facility: Universidad de Oviedo
state: Asturias
Study officials:
References: