louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05838976: Validity and Reliability of CTQ-SSS in Carpal Tunnel Syndrome.
Official title: Validity and Reliability of the Shorter Version of the CTQ-SSS in Patients With Carpal Tunnel Syndrome: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Ahram Canadian University
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of patients with carpal tunnel syndrome who are undergoing nonsurgical management.

Brief summary: To determine the validity and reliability of the shorter version of the CTQ-SSS in patients with carpal tunnel syndrome (CTS) undergoing nonsurgical management.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with carpal tunnel syndrome based on clinical presentation and/or nerve conduction studies.
* Patients aged 18 years to 60 years old.
* Patients who are undergoing nonsurgical management for carpal tunnel syndrome.

Exclusion Criteria:

* Patients with a history of hand or wrist surgery within the past 6 months.
* Patients with severe hand or wrist pain that would prevent completion of the outcome measures or interfere with their ability to participate in the study.
* Patients with severe cognitive impairment or language barrier that would prevent understanding of the study instructions or interfere with their ability to participate in the study.
* Patients with any other medical condition that could affect hand function or interfere with test completion.

Primary outcomes:
measure: Validity and Reliability of the Shorter Version of the CTQ-SSS
timeFrame: Outcome measures will be assessed within 2-4 weeks of the initial CTQ-SSS administration.
Secondary outcomes:
Other outcomes:
Locations:
city: Al Ḩayy Ath Thāmin
country: Egypt
facility: Outpatient clinic of faculty of physical therapy, Ahram Canadian University
state: Giza
Study officials:
affiliation: Faculty of Physical Therapy, Ahram Canadian University
name: Amal Fawzy, Ph.d
role: STUDY_CHAIR
References:
Clinical trial NCT05702476: Marfan Syndrome (MFS) and Facial Dysmorphism: Non-invasive 3D Assessment
Official title: Marfan Syndrome (MFS) and Facial Dysmorphism: Non-invasive 3D Assessment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rare Diseases
Marfan Syndrome
Keywords: Rare Diseases
Marfan syndrome
Facial features
Lead sponsor: IRCCS Policlinico S. Donato
Sponsor class: OTHER
Collaborators: name: University of Milan
First posted: 2023-01-27
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with clinical and/or genetic diagnosis of MFS currently in follow-up at Cardiovascular Genetic Cenrte, IRCCS Policlinico San Donato.

Brief summary: The goal of this study observational prospective study is to define the facial morphological features associated with Marfan syndrome (MFS). The main qustion it aims to answer are:

1. To describe the facial morphological features associated with MFS and their evolution over time;
2. To study the association between facial morphology and the features of reference for the diagnosis of MFS.

Detailed description: Marfan syndrome (MFS, OMIM # 154700) is a rare connective tissue disorder caused by mutations in the gene encoding fibrillin-1 glycoprotein (FBN1), involved in the development of microfibrils. Since FBN1 is a constituent of the connective tissue present at a systemic level, mutations in its gene lead to alterations of the connective tissue, even with pleiotropic effects. The clinical manifestations of MFS are heterogeneous and can occur at any time, from neonatal onset to infancy or adolescence. In this sense, the presence of facial dysmorphism could help in early diagnosis of the disease. Considering the craniofacial features, the phenotypic manifestation related to the syndrome MFS are: dolichocephaly, eyelid down-slanting, malar hypoplasia and retrognathia. However, Few studies have so far studied the facial features associated with MFS. Morevoer, there is a gap in the literature for the evaluation of the progression of facial morphology in the pediatric MFS population as well as potential correlations between facial dysmorphism and other manifestations of the disease.

Eligibility criteria: Inclusion Criteria:

* White european ethnicity;
* Signed informed consent;

Exclusion Criteria:

* Previous relevant traumas affecting the craniofacial district or maxillofacial surgery;
* Presence of beard and mustache;
* Pregnancy

Primary outcomes:
measure: Disease Progression
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Donato Milanese
country: Italy
facility: IRCCS Policlinico San Donato
state: Lombardia
Study officials:
affiliation: Cardiovascular-Gentic Centre, IRCCS Policlinico San Donato
name: Alessandro Pini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00670176: Pre- and Postoperative Cardiopulmonary Rehabilitation Reduces Complications After Coronary Artery Bypass Surgery: A Randomized Trial
Official title: Pre- and Postoperative Cardiopulmonary Rehabilitation Reduces Complications After Coronary Artery Bypass Surgery: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Bypass Surgery
Lead sponsor: Universidade do Sul de Santa Catarina
Sponsor class: OTHER_GOV
Collaborators: name: ICSC
First posted: 2008-05-01
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Pre- and postoperative cardiopulmonary rehabilitation reduces complications after coronary artery bypass surgery. This study was conducted as a randomized trial to verify this hypothesis in our institution. ICSC


Eligibility criteria: Inclusion Criteria:

* All CAB patients

Exclusion Criteria:

* SCA in the previous 24h and incapacity of doing light exercise. Valvular patients

Primary outcomes:
measure: length of stay in the ICU (in minutes); days on the ward after ICU until hospital discharge; pneumonia with the need for antibiotic treatment; and atrial fibrillation or flutter detected on daily-performed electrocardiograms
Secondary outcomes:
measure: time until oro-tracheal tube (OTT) removal, occurrence of pleural effusion, atelectasis, change in peak-flow (baseline vs. 2 hours after extubation vs. discharge), and changes in the 6-minute-walking distance between enrollment and hospital discharge.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05901376: MicroRNAs From Blood Samples as Biomarkers for Gastric Cancer Detection
Official title: MicroRNAs From Blood Samples as Biomarkers for Gastric Cancer Detection: a Diagnostic Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gastric Cancer
MicroRNAs
Lead sponsor: King Chulalongkorn Memorial Hospital
Sponsor class: OTHER
First posted: 2023-06-13
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients from King Chulalongkorn Memorial Hospital

Inclusion Criteria for Gastric Cancer group:

* Recently diagnosed gastric cancer
* Never received any treatment for gastric cancer

Inclusion Criteria for Control group:

* Age 50 or above
* Underwent elective upper gastrointestinal endoscopy and negative for gastric cancer
* No prior history of gastric dysplasia or cancer

Exclusion Criteria:

* Patients who cannot give informed consent
* Pregnancy
* Lymphoma

Brief summary: The goal of this observational study is to compare specific microRNA levels from the plasma of gastric cancer patients and healthy volunteers to see if there is an upregulated expression in gastric cancer patients.

The main question it aims to answer is:

- Can microRNAs be effectively used as diagnostic biomarkers for gastric cancer?

Participants will be asked for their consent to obtain 5 cc of blood.


Eligibility criteria: Inclusion Criteria for Gastric Cancer group:

* Recently diagnosed gastric cancer
* Never received any treatment for gastric cancer

Inclusion Criteria for Control group:

* Age 50 or above
* Underwent elective upper gastrointestinal endoscopy and negative for gastric cancer
* No prior history of gastric dysplasia or cancer

Exclusion Criteria:

* Patients who cannot give informed consent
* Pregnancy
* Lymphoma

Primary outcomes:
measure: The different of MiR-20a level between gastric cancer and control group
timeFrame: Day 1
measure: The different of MiR-21 level between gastric cancer and control group
timeFrame: Day 1
measure: The different of MiR-106b level between gastric cancer and control group
timeFrame: Day 1
measure: The different of MiR-199a level between gastric cancer and control group
timeFrame: Day 1
measure: The different of MiR-223 level between gastric cancer and control group
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
state: Not Required For This Country
Study officials:
References:
Clinical trial NCT00931476: A Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Somatropin
Official title: A Single-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group, Single Dose Trial in Healthy Caucasians and Japanese Subjects Investigating the Pharmacokinetics of Norditropin® (Norditropin® PenSet® 24)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Growth Hormone Disorder
Adult Growth Hormone Deficiency
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2009-07-02
Enrollment: 86
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial was conducted in the United States of America (USA). The aim of this clinical trial was to investigate the pharmacokinetics of somatropin in healthy Japanese and Caucasian subjects, and to identify somatostatin-related adverse events.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent before any trial related activities
* Japanese and Caucasian males respectively
* Healthy subjects based upon medical history, physical examination, vital signs, ECG, serum biochemistry and haematology and urinalysis
* Body Mass Index (BMI) between 17 and 30 m2/kg, inclusive

Primary outcomes:
measure: Area under the hGH concentration-time curve (GH AUC0-24h)
timeFrame: from 0 to 24 hours following injection
measure: Maximum hGH concentration (GH Cmax)
timeFrame: from 0 to 24 hours following injection
measure: Treatment Emergent Adverse Events
timeFrame: from 0 to 24 hours following injection
Secondary outcomes:
measure: Time to maximum hGH concentration (GH tmax)
measure: Area under the hGH concentration-time curve GH AUC0-∞)
measure: Elimination half-life (GH t½)
measure: Growth Factors (IGF-I and IGFBP-3)
measure: Non-treatment Emergent Adverse Events
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Novo Nordisk Investigational Site
state: Hawaii
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03550976: The Effect of Early Nutrition Intervention on the Incidence of High-risk Patients With Gestational Diabetes
Official title: The Effect of Early Nutrition Intervention on the Incidence of High-risk Patients With Gestational Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gestational Diabetes
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2018-06-11
Enrollment: 400
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The incidence of gestational diabetes increased.The multidisciplinary management of GDM during pregnancy is helpful to improve the pregnancy outcome, but it will occupy huge medical resources.Early prediction, diet and exercise interventions can reduce the incidence of gestational diabetes, but there is no reliable way to predict and intervene early.This study is a randomized controlled trials, and aims to use comprehensive prediction method (genetic screening, body composition, clinical risk factors screening) screening the subjects with high GDM risk in early pregnancy, conducting diet and exercise intervention in second trimester and observing the effect on the incidence of GDM and perinatal outcomes.


Eligibility criteria: Inclusion Criteria:

* early pregnant women (\< 12 weeks)
* fasting blood glucose \< / = 5.6 mmol/L and glycosylated hemoglobin \< / = 5.6%
* prepregnancy overweight (BMI \> 23.9) or body fat content more than 30% (based on body composition analysis)
* no history of major diseases or long-term drug treatment
* no obvious physical disabilities, the ability of physical activity is normal
* dietary behavior and mental is normal
* resident in Beijing, early and middle stage pregnancy can be in Beijing area to receive regular obstetric examinations
* signed informed consent
* the following at least one

  * first-degree relatives family history of diabetes
  * history of abnormal lipid metabolism or abnormal lipid metabolism
  * history of polycystic ovary syndrome
  * history of large for gestational age infant or macrosomia deliver

Exclusion Criteria:

* history of gestational diabetes mellitus
* clinical glucose metabolism abnormalities
* once taking diabetes drugs or insulin injections
* a variety of food allergies or food choices serious limitations
* exercise during pregnancy contraindication

Primary outcomes:
measure: Incidence of gestational diabetes
timeFrame: 12-28 weeks of pregnancy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03446976: CT-P13 (Infliximab) Subcutaneous Administration by Pre-filled Syringe and Auto-injector in Healthy Subjects
Official title: A Phase 1, Randomized, Open-label, Single-dose, Two-arm, Parallel Group Study to Compare the Pharmacokinetics and Safety of the Pre-filled Syringe and Auto-injector of CT-P13 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Health, Subjective
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2018-02-27
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study compares two administration methods of CT-P13. Half of participants will receive CT-P13 by pre-filled syringe while the other half will receive CT-P13 by auto-injector.

Detailed description: This is a Phase I Study to Compare Pharmacokinetics and Safety between CT-P13 SC Pre-filled Syringe and CT-P13 SC Auto-injector in Healthy Subjects. A total of 218 healthy subjects will be enrolled.

Eligibility criteria: Inclusion Criteria:

* Healthy male and female subject
* Subject voluntarily agrees to participate in this study

Exclusion Criteria:

* Subject with medical history and/or condition
* Female who is pregnant or breastfeeding, or childbearing potential.

Primary outcomes:
measure: To demonstrate comparable pharmacokinetics (PK) of CT-P13 subcutaneous (SC) administered by auto-injector (AI) versus pre-filled syringe (PFS) in healhty subjects.
timeFrame: over 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Development, LP
state: Texas
Study officials:
affiliation: Celltrion
name: SuEun Song
role: STUDY_CHAIR
References:
Clinical trial NCT01149876: Study to Evaluate the Effect of a Nu Skin Product and Device for Brown Spots
Official title: A Single Blind, Placebo Controlled Trial to Evaluate Effects of a Study Medication, a Nu Skin Lightening Product With and Without Iontophoresis vs Tretinoin Cream vs Vehicle Control for Facial Hyperpigmentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hyperpigmentation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2010-06-24
Enrollment: 80
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a topical Nu Skin product with or without a galvanic spa device improves brown spots on the face. The Nu Skin product will be compared to an over the counter moisturizer and tretinoin cream.


Eligibility criteria: Inclusion Criteria:

* Able to understand and sign informed consent.
* Able to complete study and comply with study procedures.
* Caucasian female ages 25-55.
* Presence of photodamage and lentigines of II-III on the Glogau Photoaging
* Must be willing to avoid laser and light treatments, treatments with filler, chemical peels, microdermabrasion, Botox or any other cosmetic treatment to the face during the duration of the study.
* Must be willing to avoid changing topical moisturizers and cosmetics during the study.
* Able to stop any alpha or beta hydroxy acids, topical retinol or retinoid derivatives, topical antioxidants, or any topical product that may interfere with the study 2 weeks prior to the study.

Exclusion Criteria:

* Cosmetic treatment of face, such as laser or light treatment, filler, Botox, microdermabrasion, or chemical peels 6 months prior to study or during study.
* Current smoker.
* Pregnant, nursing, or planning to become pregnant during study.
* Currently taking drugs including oral retinoids or any other medication with a known clinically significant drug interaction with topical tretinoin.
* Known hypersensitivity to retinoids. History of severe retinoid dermatitis.
* History of substance abuse, mental dysfunction, or other factors limiting ability to cooperate with study.
* Concurrent participation in another clinical study or participation 30 days prior to enrollment that includes exposure to an investigational drug that would interfere with this study.
* Any disease or condition which would interfere with study participation or unduly increase risk.
* Presence of an electrically sensitive support system such as a pacemaker.
* Known history of epilepsy.
* Presence of metal implants or metal braces on teeth.

Primary outcomes:
measure: Change in Hyperpigmentation of the Face
timeFrame: baseline to 16 weeks
Secondary outcomes:
measure: Change in Rhytides
timeFrame: baseline to week 16
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: MGH
name: Molly Wanner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06403176: Arteriovenous Plasma Multiomics in Patients With Disorders of Consciousness
Official title: Arteriovenous Plasma Multiomics and Inflammatory Factors in Patients With Disorders of Consciousness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorders of Consciousness
Transient Ischemic Attack
Keywords: Plasma metabolism
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with consciousness disorder caused by various severe brain injuries were recruited at Intensive care unit of The First Affiliated Hospital of Zhejiang University and Intensive care unit of the Second Affiliated Hospital of Zhejiang University

Brief summary: In order to determine the abnormal cerebral metabolism in the pathological state, we compared the blood of internal jugular vein, superior vena cava and radial artery during central venous catheterization. Metabonomics, proteomics and inflammatory factor microarray were used to detect the material differences in arteriovenous blood of patients with disorders of consciousness. At the same time, we concurrently compared it with the peripheral plasma metabolome of two additional patient cohorts: those in-stent restenosis and non-restenosis.

Detailed description: Background:It is unclear what substances the brain needs to ingest for its activity under pathological conditions

Method:The uptake and release of substances by the brain were observed by comparing arterial blood with internal jugular vein blood;The characteristics of brain metabolites were observed by comparing internal jugular vein blood with superior vena cava blood. Compared it with the peripheral plasma metabolome of two additional patient cohorts: those in-stent restenosis and non-restenosis.

Objective:By analyzing different substances, this paper briefly describes the pathological mechanism of patients with disorders of consciousness, and looks for potential prognostic biomarkers.

Eligibility criteria: Inclusion Criteria:

1.Patients with consciousness disorder caused by various severe brain injuries

Exclusion Criteria:

1. Patients who have been judged brain dead
2. There are persistent epileptic activity, inhibition or seizure inhibition patterns
3. Recent fever, abnormal liver and kidney function
4. Previous history of neurological or mental illness
5. Have a history of tumor
6. Inflammatory bowel diseases, hyperlipidemia, gastritis

Primary outcomes:
measure: Patient clinical outcome
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT03190876: Seroma Prevention After Body Contouring Procedures
Official title: Prevention of Seroma Formation After Body Contouring Procedures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Seroma
Abdominoplasty
Complication of Surgical Procedure
Keywords: Drain usage
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2017-06-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: With a prevalence of up to 25%, seroma formation is among the most common complications of body contouring procedures such as abdominoplasty. Small amounts of fluid are reabsorbed by the body spontaneously, however, larger seroma volumes need to be evacuated via puncture aspiration to prevent wound healing disturbances and infection, leading to major patient discomfort and a prolonged hospital stay. There is increasing controversy regarding the efficacy of surgical drains in seroma prevention. This study compares the incidence rate of seroma in three study arms with different usage of drains.


Eligibility criteria: Inclusion Criteria:

* All full-aged patients requiring body contouring procedures in our department who provide oral and written informed consent indicating that they agree to participate in the study

Exclusion Criteria:

* Minors or patients with a designated health care proxy, revision surgeries, morbid obesity

Primary outcomes:
measure: Rate of seroma formation
timeFrame: Weekly follow-up until postoperative week 6.
Secondary outcomes:
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Department of Plastic Surgery, University Hospital of Regensburg
state: Bayern
Study officials:
References: