louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04797793: A Study Comparing Adapalene Gel 0.1% and to Differin Gel in the Treatment of Acne Vulgaris
Official title: A Double-blind, Randomized, Placebo Controlled Study to Compare Adapalene Gel 0.1% to Differin Gel and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Acne Vulgaris
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2021-03-15
Enrollment: 978
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate therapeutic equivalence and safety of adapalene gel 0.1% (Taro Pharmaceuticals U.S.A., Inc.) and Differin® Gel (Adapalene Gel 0.1%, Galderma) in the treatment of acne vulgaris.

Detailed description: A multi-center, double-blind, randomized, placebo controlled, parallel-group study, Adapalene Gel 0.1% (Taro Pharmaceuticals U.S.A, Inc.) and to Differin® Gel (Adapalene 0.1%, Galderma) and both active treatments to a placebo control in the treatment of acne vulgaris

Eligibility criteria: Inclusion Criteria:

* Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
* Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. Subjects ages 12 to 17 years of age inclusive must have provided IRB approved written assent;
* Subjects must have a definite clinical diagnosis of acne vulgaris of severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA)

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
* Subjects with a history of hypersensitivity or allergy to tretinoin, retinoids, or any of the study medication ingredients.
* Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).

Primary outcomes:
measure: The percentage change in the inflammatory and non-inflammatory lesion counts
timeFrame: Baseline to Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Catawba Research, LLC
state: North Carolina
Study officials:
affiliation: Catawba Research
name: Zaidoon A. Al-Zubaidy
role: STUDY_DIRECTOR
References:
Clinical trial NCT01029093: Effects of Sensory and Motor Deprivation on Brain Plasticity
Official title: Effects of Sensory and Motor Deprivation on Brain Plasticity After Injury and Immobilisation of Right Upper Extremity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Injury of the Right Upper Extremity
Keywords: extremity with immobilisation
brain platicity
deprivation
MRI
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Jaencke
First posted: 2009-12-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with injury of right upper extremity

Brief summary: Investigation of changes in gray and white matter during immoblisation after injury of the right upper extremity via two MR Investigations of the brain at two different times.

Detailed description: Investigation of changes in gray and white matter during immoblisation after injury of the right upper extremity via two MR Investigations of the brain at two different times. Immobilisation at least 12 days. Time between the 2 investigations: 12-14 d.

Eligibility criteria: Inclusion criteria:

* Right handed
* Injury of right upper extremity where immobilisation is needed

Exclusion criteria:

* TBI, neurological or psychatric deseases
* Other cerebral deseases
* Standard MRI Exclusion criterias such as pacemaker, epilepsia etc

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Devision of Traum
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT06760793: Deep Friction Massage in Children With Spastic Cerebral Palsy
Official title: Comparison of the Effectiveness of Static Stretching and Deep Friction Massage Applied to Plantar Flexors in Children With Spastic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spastic Cerebral Palsy (sCP)
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 46
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this clinical trial is to determine whether deep friction massage and stretching reduce muscle contraction in the calf muscle. The primary questions it seeks to answer are:

* Does deep friction massage or stretching reduce muscle contraction?
* Does deep friction massage or stretching improve walking?
* Does deep friction massage or stretching increase ankle joint range of motion?

Participants:

Participants will undergo either deep friction massage or stretching exercises for 10 minutes, three days a week, over a period of six weeks.


Eligibility criteria: Inclusion Criteria:

* a diagnosis of spastic diplegic or hemiparetic CP
* aged between 3 and 18 years
* classified as level I, II, or III according to the Gross Motor Function Classification System (GMFCS)
* possessing sufficient cognitive function to cooperate.

Exclusion Criteria:

* Botulinum toxin (BoNT) injections to the lower extremity muscles within the last six months
* undergoing any surgery such as muscle lengthening or joint contracture within the last six months
* non-participation in two consecutive exercise sessions
* experiencing illnesses such as infections or musculoskeletal injuries during the study period.

Primary outcomes:
measure: The Modified Ashworth Scale
timeFrame: before intervention and after 6 weeks
Secondary outcomes:
measure: The Modified Tardieu Scale
timeFrame: Before intervention and after 6 weeks
measure: Range of motion (ROM)
timeFrame: Before intervention and after 6 weeks
measure: The Modified Timed Up and Go Test (TUG)
timeFrame: Before intervention and after 6 weeks
Other outcomes:
Locations:
city: Muğla
country: Turkey
facility: Mugla Sitki Kocman University
state: Menteşe
Study officials:
References:
Clinical trial NCT04158193: Acupuncture for Breast Cancer Related Lymphedema
Official title: Effectiveness of Acupuncture for Breast Cancer Related Lymphedema Patients: a Multicenter, Randomized, Sham-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer Lymphedema
Lead sponsor: Tianjin University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Baokang Hospital Affiliated to Tianjin University of Traditional Chinese Medicine
name: Tianjin Medical University Cancer Institute and Hospital
name: Gansu Provincial Cancer Hospital
name: The Second Affiliated Hospital of Baotou Medical College
First posted: 2019-11-08
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical efficacy of acupuncture on chronic upper limb lymphedema in patients with breast cancer surgery


Eligibility criteria: Inclusion Criteria:

* At least 6 months after breast cancer surgery and presents with persistent breast cancer related upper extremity lymphedema for at least 3 months.
* Stage II lymphedema according to the 2016 consensus by the international society of lymphology.
* Women aged 18 to 80 years
* Out-patients
* Estimated life expectancy \> 6 months
* Upper extremity lymphedema is defined a more than 10% volume difference between the affected and unaffected arms

Exclusion Criteria:

* Bilateral breast cancer related lymphedema
* Tumor metastasis or recurrent patient
* Patients who is undergoing chemotherapy, radiation therapy or targeted therapy
* Taking diuretic
* Upper extremity lymphedema reached more than 80% volume difference between the affected and unaffected arms
* History of primary lymphedema
* A diagnosis of severe heart, liver, kidney or hematologic disease
* Edema caused by upper extremity disability or other conditions such as heart failure, kidney disease or malnutrition
* Have hypoproteinemia
* Inflammation, scar, or trauma at the site of operation, or other active skin infections
* Unable to self-care, had a history of psychological disorders, or unable to communicate
* Received lymphedema treatment within the past 1 month
* Pregnancy or breastfeeding
* The presence of electronic medical device implants
* Deny to sign the informed written consent, or unwilling to conform to randomization
* Participation in other clinical trials during the study period

Primary outcomes:
measure: Upper extremities volume
timeFrame: 7 weeks
Secondary outcomes:
measure: Upper extremities circumferences
timeFrame: 7 weeks
measure: VAS distension score
timeFrame: 7 weeks
measure: Common terminology criteria for adverse events (CTCAE 4.03) - edema limbs criteria
timeFrame: 7 weeks
measure: The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure
timeFrame: 7 weeks
measure: The MOS 36-Item Short-Form Health Survey (SF-36)
timeFrame: 7 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00856193: A Study to Investigate the Bronchodilatory Effect of NVA237 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Randomized, Double-blind, Placebo-controlled, Multi-center, Two-period Crossover Study to Investigate the Bronchodilatory Effect of 50 µg NVA237 Inhaled Once Daily in Patient With Chronic Obstructive Pulmonary Disease (COPD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Bronchodilator
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-03-05
Enrollment: 33
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study was intended to assess how well inhaled NVA237 opens up the airways of patients with mild, moderate or severe COPD over a 24 hour period after a 14 day treatment period.


Eligibility criteria: Inclusion Criteria:

* Male or female aged greater than 40 years with COPD Current or ex-smokers

Exclusion Criteria:

* Cardiac (heart) disorders, history of asthma, requiring oxygen therapy. Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-24 Hours on Day 14
timeFrame: From Day 1 to 0-24 hours after drug administration on Day 14
Secondary outcomes:
measure: Forced Expiratory Volume in One Second (FEV1) AUC 0-12 Hours on Day 14
timeFrame: From day 1 to 0 -12 hours after drug administration on Day 14
measure: Forced Expiratory Volume in One Second (FEV1) AUC 12-24 Hours on Day 14
timeFrame: From Day 1 to 12 hours-24 hours after drug administration on Day 14
measure: Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs)
timeFrame: Day 14
Other outcomes:
Locations:
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Albrechtstrasse 14
country: Germany
facility: Harrison Clinical Research Deutschland GmbH
state: Munich
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00178893: Hepatocellular Research Registry
Official title: CellzDirect: Hepatocellular Research Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocytes
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient having liver resection operation.

Brief summary: This is a registry of human hepatocytes (liver cells) for research purposes.

Detailed description: Patients scheduled for partial hepatectomy/liver surgery are asked permission to use their discarded liver tissue for purposes of studying:

1. how drugs/medicines affect the liver and
2. the effects of storing liver cells in the cold or freezing.

Eligibility criteria: Inclusion Criteria:

* Persons undergoing partial hepatectomy/liver surgery for any reason.

Exclusion Criteria:

* Persons with known HIV, hepatitis B virus (HBV), or hepatitis C virus (HCV)
* A diagnosis of hepatocellular carcinoma without negative serologies
* A diagnosis of cholangiocarcinoma, where the total bilirubin has ever been greater or equal to 3.0
* The presence of a biliary drainage tube
* Active sepsis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Sunil K Geevarghese, MD, MSCI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05879393: The Multistrain Probiotic OMNi-BiOTiC® Active for Upper Respiratory Tract Infections in Older People
Official title: The Effect of the Multistrain Probiotic OMNi-BiOTiC® Active for Upper Respiratory Tract Infections in Older People: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Upper Respiratory Tract Infection
Lead sponsor: University Maribor
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 95
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this randomised controlled trial is to determine the effect of consuming a multistrain probiotic OMNi-BiOTiC® Active to shorten the incidence and duration of acute upper respiratory tract infections (URTIs) in older people. The main questions it aims to answer is:

* Is the multistrain probiotic OMNi-BiOTiC® Active effective in reducing the incidence of URTIs in older people?
* Is the multistrain probiotic OMNi-BiOTiC® Active effective in reducing the duration of URTIs in older people?
* Is the multistrain probiotic OMNiBiOTiC® Active effective in changing selected immunological blood parameters in older people? Researchers will compare the probiotic group and the placebo group to see if the incidence or duration of URTIs are significant among the groups.


Eligibility criteria: Inclusion Criteria:

* 65 years or older at the signing of the written consent form
* ability of participant to eat independently
* ability of participant to adhere to all procedures of the clinical study

Exclusion Criteria:

* participants experienced an exacerbation of an existing chronic disease
* participants experienced an exacerbation of metabolic diseases,
* participants with mental incapacity to understand instructions
* participants were prescribed long-term usage of antibiotics.
* participants that changed their eating habits or consumed any probiotics 14 days
* participants with markedly abnormal results of blood tests were excluded.

Primary outcomes:
measure: Incidence of URTI
timeFrame: 12 weeks supplementation
Secondary outcomes:
measure: Duration of URTI
timeFrame: 12 weeks supplementation
measure: Changes in concentration of leukocytes, neutrophils segm., lymphocytes, monocytes, eosinophils, basophils in serum
timeFrame: 12 weeks supplementation
measure: Changes in concentration of Immunoglobulin A (IgA) in serum
timeFrame: 12 weeks supplementation
Other outcomes:
Locations:
city: Maribor
country: Slovenia
facility: University of Maribor, Faculty of Health Sciences
Study officials:
affiliation: University of Maribor, Faculty of Health Sciences
name: Sabina Fijan, Ph.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT00675493: Observational Study of Type 1 and Type 2 Diabetes Patients Having Switched From Human Premixes to NovoMix®30
Official title: A Prospective, Multicentre, Open Label, Non-controlled, Observational, 24-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) for Treatment of Type 1 and Type 2 Diabetes Mellitus in Romania
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-05-09
Enrollment: 942
Sex: ALL
Minimum age (years): 10
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 1 and type 2 diabetes patients inadequately controlled on human premixes

Brief summary: This trial is conducted in Europe. The aim of this observational study is to evaluate the blood glucose control (HbA1c) using NovoMix® 30 for treatment of type 1 and type 2 diabetes under normal clinical practice conditions in Romania.


Eligibility criteria: Inclusion Criteria:

* Type 1 and type 2 diabetics who are treated with human premix insulin (the selection of the subjects will be at the discretion of the individual physician).

Exclusion Criteria:

* Subjects currently being treated with biphasic insulin aspart 30
* Subjects who were previously enrolled in this study
* Subjects with a hypersensitivity to biphasic insulin aspart 30 or to any of the excipients
* Women who are pregnant or have the intention of becoming pregnant within next 6 months
* Children below 10 years of age

Primary outcomes:
measure: Change in HbA1c from baseline
timeFrame: For the duration of the study
Secondary outcomes:
measure: Percentage of subjects achieving HbA1c below 7.0% and below or equal to 6.5%
timeFrame: after 12 weeks and 24 weeks of treatment
measure: Change in FPG (glucose variability)
timeFrame: after 12 weeks and 24 weeks of treatment
measure: Change in PPG (postprandial control)
timeFrame: after 12 weeks and 24 weeks of treatment
measure: Change in insulin dose and number of injections
timeFrame: at 12 weeks and 24 weeks of treatment
measure: Change in oral antidiabetic drug therapy
timeFrame: after 12 weeks and 24 weeks of treatment
measure: Change in body weight
timeFrame: at 12 weeks and 24 weeks of treatment
measure: Change in number of hypoglycaemic events
timeFrame: during 4 weeks proceeding routine visits at 12 weeks and 24 weeks of treatment
measure: Number of adverse drug reactions (ADR)
timeFrame: after 12 weeks and 24 weeks of treatment
Other outcomes:
Locations:
city: Bucharest
country: Romania
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04520893: Ventilation Strategy for the Elderly Patients in Prone Position
Official title: Modification of Ventilation Strategy for the Elderly Patients During Spine Surgery in Prone Position
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ventilators, Mechanical
Keywords: geriatric medicine, protective ventilation, prone position
Lead sponsor: Hallym University Kangnam Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 45
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators compare three ventilation modes; volume controlled ventilation, volume guaranteed pressure controlled ventilation and volume controlled ventilation with pause during spine surgery for the elderly patients. The investigators can reveal that how lung collapse can be reduced by optimizing the inspiratory flow pattern under general anesthesia.

Detailed description: \<Protocol\>

1. All patients were ventilated by an anaesthesia ventilator (Zeus, Dräger, Lübeck, Germany) under general anesthesia.
2. Ventilation strategy:

   * Pressure controlled ventilation volume guaranteed (PCV-VG) mode or volume control ventilation (VCV) mode
   * tidal volume 6-8 mL/kg (predicted body weight)
   * Inspiratory/expiratory (I/E) ratio 1:1.5
   * Inspired oxygen concentration (FIO2) 0.5 with air
   * 3.0 L/min of inspiratory fresh gas flow
   * Positive end-expiratory pressure (PEEP) of 5 cm H2O
   * Respiratory rate (RR) of 10 to 14 min-1
3. After prone positioning and hemodynamic condition was stabilized, patients were ventilated with VCV, PCV-VG mode, VCV with pause following a randomized order, previously determined for each patient. Before each ventilator setting was started, lung recruitment maneuvers were performed to set the lungs to a defined baseline status.

   * ventilation order : one of the following examples is taken by randomization.

VCV 15 min -- VCV pause 15min -- PCV-VG 15min

VCV 15 min -- PCV-VG 15min -- VCV pause 15min

VCV pause 15min -- VCV 15 min -- PCV-VG 15min

VCV pause 15min -- PCV-VG 15min -- VCV 15 min

PCV-VG 15min -- VCV 15 min -- VCV pause 15min

PCV-VG 15min -- VCV pause 15min -- VCV 15 min

Eligibility criteria: Inclusion Criteria:

* patients undergoing elective spine surgery under general anesthesia

Exclusion Criteria:

* obesity (body mass index \>35 kg/m2)
* chronic obstructive pulmonary disease
* respiratory infection

Primary outcomes:
measure: MVCO2
timeFrame: ventilation 15 min later
Secondary outcomes:
measure: airway pressure
timeFrame: ventilation 15 min later
measure: airway compliance
timeFrame: ventilation 15 min later
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Hospital
Study officials:
affiliation: Hallym University Kangnam Sacred Heart Hospital
name: Eunhee Chun, MD.,PhD.
role: PRINCIPAL_INVESTIGATOR
References: