louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06491992: Chitosan Phonophresis on Cervical IN Smartphone Addicted Users
Official title: Effect of Chitosan Phonophresis on Cervical Pain and Disability in Smartphone Addicted Users
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervical Pain
Lead sponsor: October 6 University
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A phonophoresis-based drug delivery system is a synchronous approach to improve local drug penetration in neuromuscular diseases associated with neuronal damage, excruciating pain, and local inflammation. Chitosan, a semi-synthetic material, is obtained by partial deacetylation of chitin amines, resulting in copolymers of N-acetylglucosamine and N-glucosamine. Its use has been explored in various biomaterial and medical applications. Chitosan has emerged as a cost-effective, biocompatible, and biodegradable material with many desirable biological properties, improvement of homeostasis and antiviral potential. Chitosan was found to suppress pro-inflammatory cytokines and decreased peripheral nerve edema, the polycationic nature of chitosan allows it to absorb protons, which reduces inflammation and provides an analgesic effect.

Detailed description: The patients will randomly be divided into two equal groups; the control group which will receive the selected exercise program and the study group will receive the same exercise training program in addition to Chitosan Phonophresis, three times per week for four weeks.

Eligibility criteria: Inclusion Criteria:

* Their age will be ranged from 16-18 years
* body mass index will be 26.58 kg/m2.
* used a smart phone for more than 1 year for at least 2 hours per day
* complaining of neck pain after using a smart phone, addiction to smart phone in accordance with the smart phone addiction scale (SAS)

Exclusion Criteria:

* any previous head and neck injuries or surgeries
* any congenital abnormalities or symptomatic deformity in either the cervical or the lumbar spine
* any uncorrected visual or auditory problems, dizziness, vertigo and headache
* any systematic diseases, any addiction to alcohol, any additive drugs and sedatives within 48 hours previous to tests
* body mass index of subjects over25 kg/m2.

Primary outcomes:
measure: Smartphone Addiction Scale-Short Version (SAS-SV)
timeFrame: four weeks
measure: The visual analogue scale
timeFrame: four weeks
measure: Neck disability index
timeFrame: four weeks
Secondary outcomes:
measure: Cervical ROM
timeFrame: four weeks
Other outcomes:
Locations:
city: Al Jīzah
country: Egypt
facility: Lama S Mahmoud
state: Select State
Study officials:
References:
Clinical trial NCT01723592: Orall Administered Probiotics to Improve the Quality of the Vaginal Flora of Women With Breast Cancer and Chemotherapy.
Official title: The Ability of an Orally Administered Preparation of Four Lactobacillus Species to Improve the Quality of the Vaginal Flora of Women With Breast Cancer and Chemotherapy. A Prospective Randomized Placebo-controlled, Double-blind Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: chemotherapy
vaginal flora
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
Collaborators: name: University of Natural Resources and Life Sciences, Vienna, Austria
First posted: 2012-11-08
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is the improvement of the vaginal flora by at least two grades of the Nugent scale after application of oral probiotics.

Detailed description: The aim of this study is the improvement of the vaginal flora by at least two grades of the Nugent scale. Improvement of Nugent scores should be considered the primary end point of the study. The outcome of the study would be considered positive if significantly more women in the verum cohort achieve such improvement than in the placebo cohort.

Eligibility criteria: Inclusion Criteria:

Only women with breast cancer and neoadjuvant / adjuvant chemotherapy, at least 4 weeks postoperative, without vaginal bleeding without abnormal vaginal discharge, Only women with Nugent scores between 4 and 6

Exclusion Criteria:

Patients with diarrhoea, constipation, vaginal or urinary tract infection requiring antibacterial treatment and women receiving antibiotic therapy in the previous 4 weeks.

Primary outcomes:
measure: change in Nugent score between baseline and end of treatment (improvement or no improvement)
timeFrame: day 0, 7 and day 14 of oral probiotic application
Secondary outcomes:
measure: Isolation of specific Lactobacilli from vaginal microbiologic cultures after oral administration of probiotic
timeFrame: day 0, 7 and day 14 after oral probiotic application
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna - Department of Obstetrics and Gynecology
Study officials:
affiliation: Medical University of Vienna, Dept. of Obstetrics and Gynecology
name: Herbert Kiss, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00655044: Evaluation of Levemir® for the Treatment of Type 1 and 2 Diabetes
Official title: Observational, Safety Study in Subjects Using Levemir® (Insulin Detemir) for the Treatment of Type 1 or Type 2 Diabetes Mellitus
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: 2008-04-09
Enrollment: 3637
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 1 and type 2 diabetes patients

Brief summary: This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using Levemir® under normal clinical practice conditions.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes
* Type 2 diabetes
* Candidates of use of a basal insulin as part of their diabetes regimen

Exclusion Criteria:

* Unwilling to adhere to therapy or follow up
* Pregnancy

Primary outcomes:
measure: HbA1C
timeFrame: after 12 weeks
Secondary outcomes:
measure: Safety
timeFrame: during treatment
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06750744: Predictors of Antimicrobial Resistance in the Respiratory Intensive Care Unit of Alexandria Main University Hospital
Official title: Predictors of Antimicrobial Resistance in the Respiratory Intensive Care Unit of Alexandria Main University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Identify the Predictors of Antibiotic Resistance
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The current study aims to identify the predictors of antibiotic resistance in the respiratory intensive care unit of Alexandria main university hospital

Brief summary: The goal of this clinical trial is to identify the predictors of antibiotic resistance whether clinical or laboratory or radiological or all

Detailed description: The goal of this clinical trial is to identify the predictors of antibiotic resistance like the history of previous antibiotic ,the antibiogram of the centre , comorbidities,..etc to decide the suitable antibiotic

Eligibility criteria: Inclusion Criteria:

* Adult patient admitted to the respiratory ICU due to bacterial infection.

  * Recent antibiotic intake in the past three months.
  * Intercostal tube insertion for empyema.
  * Shocked patients with inserted central venous catheter.
  * Intubated or tracheostomized patients.
  * Patients with grade two to four bed sores.

Exclusion Criteria:

* . Inability to provide written informed consent for the study.

  * Non sterile sample collection technique.
  * Inability to provide antibiogram.
  * Isolated patients due to suspected tuberculosis

Primary outcomes:
measure: antibiogram
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
measure: resistance rates in the antibiogram
timeFrame: 3 months
Locations:
city: Alexandria
country: Egypt
facility: Chest Department -Faculty of Medicine
state: Azarita
Study officials:
affiliation: Alexandria University
name: mohamed sabry eltarhony, lecturer
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00653744: Rosuvastatin Versus Atorvastatin in the Treatment of Hypercholesterolaemia in African American Subjects(ARIES)
Official title: A 6-Week, Randomized, Open-Label, Comparative Study to Evaluate the Efficacy and Safety of Rosuvastatin Versus Atorvastatin in the Treatment of Hypercholesterolaemia in African American Subjects. (ARIES)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Dyslipidaemia
Keywords: Cholesterol
low density lipoproteins
dyslipidaemia
Rosuvastatin
Crestor
Atorvastatin
Lipitor
African American
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-04-07
Enrollment: 1700
Sex: ALL
Minimum age (years): 18
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 compare the effect of 6 weeks of treatment with Rosuvastatin with 6 weeks of treatment with Atorvastatin in African American subjects with hypercholesterolemia.


Eligibility criteria: Inclusion Criteria:

* Fasting low density lipoprotein level as defined by the protocol.
* Self described African American race
* Fasting triglyceride level as defined by the protocol.

Exclusion Criteria:

* The use of lipid lowering drugs or dietary supplements after Visit 1.
* Active arterial disease eg Unstable angina, or recent arterial surgery
* Blood lipid levels above the limits defined in the protocol.
* Uncontrolled hypertension, hypothyroidism, alcohol or drug abuse.

Primary outcomes:
measure: Low density lipoproteins cholesterol levels
timeFrame: 6 weeks
Secondary outcomes:
measure: Other blood lipid level changes
timeFrame: 6 weeks
measure: Safety: adverse events & abnormal laboratory markers
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Heartbeats Life Centre, New Orleans, USA
name: Keith Ferdinand
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca
name: Russell Esterline
role: STUDY_DIRECTOR
References:
Clinical trial NCT05808244: Tele-group Cognitive Behavioural Family Intervention (tgCBFI) for People With Schizophrenia and Their Families
Official title: A Randomised Controlled Study on Feasibility of Tele-group Cognitive Behavioural Family Intervention (tgCBFI) for People With Schizophrenia and Their Families
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Psychosis
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: The University of Hong Kong
name: Queen Mary Hospital, Hong Kong
name: Kowloon Hospital, Hong Kong
name: Nethersole Institute of Continuing Holistic Health Education
First posted: 2023-04-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This mixed-method study aims to examine the feasibility of delivering tgCBFI programme to dyads of people with schizophrenia and their family caregivers, and generate preliminary evidence on the effectiveness of tgCBFI in reducing expressed emotion. The research questions are as follows.

1. What are the feasibility, acceptability, and safety of conducting a tele-group CBFI programme for people with schizophrenia and their family caregivers?
2. What effect does tgCBFI have on the expressed emotion experienced by adults with schizophrenia and the caregiving experience of their family caregivers at posttreatment and 12-week after completion of the programme?
3. What effect does tgCBFI have on the positive and negative symptoms of adults with schizophrenia and the perceived care burden and level of mood disturbance of their family caregivers at posttreatment, and 12-week after completion of the programme?


Eligibility criteria: Inclusion Criteria:

Service users

* diagnosis of schizophrenia-spectrum disorders, based on ICD-10 made by the treating clinicians
* aged 18 to 64
* able to communicate in Cantonese

Family caregivers

* aged 18 or above
* able to communicate in Cantonese
* live with service users

Exclusion Criteria:

Service users

* have co-morbidity of learning disability, organic/neurological conditions, or substance misuse disorder
* live in hostel

Family caregivers

-have active psychiatric conditions

Primary outcomes:
measure: Level of service satisfaction of service users and family caregivers
timeFrame: Immediate posttreatment
measure: Feasibility, acceptability, and safety of the programme
timeFrame: Throughout the whole programme
Secondary outcomes:
measure: Perceived expressed emotion of service users
timeFrame: up to 12-week follow up
measure: Positive and negative symptoms of service users
timeFrame: up to 12-week follow up
measure: Mood disturbance of family caregivers
timeFrame: up to 12-week follow up
measure: Perceived care burden of family caregivers
timeFrame: up to 12-week follow up
measure: Qualitative feedback from service users and family caregivers
timeFrame: Immediate posttreatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01351844: The CEASE Study: Computer Based Educational Module for the Reduction of Arthralgia Syndrome Associated With Endocrine Therapy for Breast Cancer
Official title: Computer Based Educational Module for the Reduction of Arthralgia Syndrome Associated With Endocrine Therapy for Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Arthralgia
Keywords: Aromatase inhibitor
Arthralgia Syndrome
Exercise
Lead sponsor: George Washington University
Sponsor class: OTHER
First posted: 2011-05-11
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients have been asked to participate in the CEASE study because their treating oncologist has recommended that they start an aromatase inhibitor medication. These medications are associated with joint complaints. The purpose of this study is to see whether a computer-based educational module is a feasible intervention to help address these symptoms. If the patients agree to participate, a research coordinator will test their grip strength and give them a computer log-on code. They will be shown how to log-on to complete the educational module and a few simple questionnaires. Patients have the option to do this from home if they wish. In 3 months time, the investigators will ask patients to return to the clinic and have another grip strength evaluation and complete some additional questionnaires. The computer module and the follow up visit will each take about 30 minutes of time.


Eligibility criteria: Inclusion Criteria:

* Post-menopausal stage I-III breast cancer patients
* Starting or about to start aromatase inhibitor
* English speaking with ability to read, write and use a computer to watch and listen to an educational module.
* Able to give informed consent

Exclusion Criteria:

* Aromatase inhibitor (AI) use for more than 6 months
* Metastatic breast cancer
* Non-English speaking, or unable to read, write or use a computer to watch and listen to an educational module.
* Unable to give informed consent

Primary outcomes:
measure: Feasibility
timeFrame: 3 months
Secondary outcomes:
measure: Grip Strength
timeFrame: 3 months
Other outcomes:
Locations:
city: Washington, D.C.
country: United States
facility: Victoria Shanmugam
state: District of Columbia
Study officials:
affiliation: Georgetown University Hospital
name: Victoria K Shanmugam, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02814344: Comparative Study of the Propagation of Uterine Electrical Activity (EHG) in Pregnant Women During Pregnancy and During Labour
Official title: Comparative Study of the Propagation of Uterine Electrical Activity (EHG) in Pregnant Women During Pregnancy and During Labour
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Uterine Contraction
Pregnancy
Delivery, Obstetric
Keywords: labour
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 27
Sex: FEMALE
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: pregnant women

Brief summary: The original aspect of the methodology proposed for this study concerns the use of as many as 16 electrodes to study the propagation and coordination (or synchronization) of uterine contraction. Over the last two years, the Compiègne University of Technology and the University of Reykjavik (Iceland) teams have developed the tools required to obtain good quality signals during electrohysterography and have worked on filtering and mapping of uterine electrical activity derived from these signals.


Eligibility criteria: Inclusion Criteria:

* singleton pregnancy

Exclusion Criteria:

* Minor patient
* twin pregnancy or more

Primary outcomes:
measure: parameter H2
timeFrame: H2 value measured at each contraction during 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Jean GONDRY, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02365844: Multispectral Imaging to Characterize Patterns of Vascular Supply Within Lymphoepithelial Mucosa in Oropharyngeal Cancer
Official title: Multispectral Imaging to Characterize Patterns of Vascular Supply Within the Lymphoepithelial Mucosa of Patients With Known or Suspected Oropharyngeal Carcinoma (OPC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oropharyngeal Carcinoma
Oropharynx Cancer
Keywords: Narrow Band Imaging
oropharyngeal carcinoma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2015-02-19
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stanford Cancer Center patients with oropharyngeal carcinoma

Brief summary: The purpose of this study is to characterize the blood supply at the base of the tongue and within the tonsil region. We hypothesize that high-resolution Narrow Band Imaging (NBI) will improve the diagnosis of oropharyngeal carcinoma (OPC). The goal is to provide the better assessment of tumor and thus providing better preoperative expectations to patients with OPC or tumor extent prior to radiation therapy.


Eligibility criteria: Inclusion Criteria:

* age 18 years or older
* Written informed consent
* Patients with oropharyngeal carcinoma

Exclusion Criteria:

* Tumors of the oral cavity or nasopharynx

Primary outcomes:
measure: assessment of differential vascularity between normal and clinically apparent tumor with in the specified sites of oropharynx, using standard white-light endoscopy and narrow-band imaging
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Chris Holsinger
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01011244: Safety and Efficacy Study of Autologous Cultured Adipose -Derived Stem Cells for the Crohn's Fistula
Official title: A Phase II Clinical Study of ADIPOPLUS (Autologous Cultured Adipose-derived Stem Cell) for the Treatment of Crohn's Fistula to Evaluate Safety and Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Crohn's Fistula
Lead sponsor: Anterogen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-11-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Up to date, a sure cure for Crohn's fistula does not known and the fistula recurrence rate is high. On 15 October 2008, orphan designation was granted by Korea FDA for human adipose-derived stem cell (ADIPOPLUS) for the treatment of Crohn's fistula. In this study, patients are given injection of ADIPOPLUS in fistula site and followed for 8 weeks to evaluate the safety and efficacy.


Eligibility criteria: Inclusion Criteria:

* Older than 18 years
* Prior diagnosis of Crohn's disease
* patients who have Crohn's fistula
* negative for serum beta-HCG for woman of childbearing age
* agreement to participate, with signed informed-consent

Exclusion Criteria:

* patients who have allergy to bovine-derived materials or an anesthetic
* patients with a diagnosis of auto immune disease except for Crohn's disease
* Diagnosis of HBV, HCV, HIV and other infectious disease
* Patients who have a symptom of septicemia
* Patients with a diagnosis of active Tuberculosis
* Patient who are pregnant or breast-feeding
* Patients who are unwilling to use an "effective" method of contraception during the study
* Patients with a diagnosis of Inflammatory Bowel Disease except for Crohn's disease
* Patients who are sensitive to Fibrin glue
* Patients who have a clinically relevant history of abuse of alcohol or drugs, habitual smoker
* Insufficient adipose tissue for manufacturing of ADIPOPLUS
* Patients who are considered not suitable for the study by investigator
* Patients with a diagnosis of active refractory Crohn's disease
* Patients who have history of surgery for malignant cancer in the past 5 years
* Patients who have \> 2 cm diameter of fistula

Primary outcomes:
measure: Efficacy: complete closure of fistula at week 8
timeFrame: 8 weeks
measure: number of patients with any adverse event
timeFrame: Day 0, Week 8
Secondary outcomes:
measure: Photo of target fistula
timeFrame: 8 weeks
measure: number of patients with any adverse events
timeFrame: 8 weeks
measure: number of patients with complete closure of fistula
timeFrame: 8 weeks
measure: Investigator's satisfaction
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan medical center
Study officials:
affiliation: Asan Medical Center
name: CS Yu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: