louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06825533: The Prevalence of Prediabetes in Primary Care Medicine in Tunisia
Official title: The Prevalence of Prediabetes in Primary Care Medicine in Tunisia. a National Descriptive Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Prediabetes
Keywords: Prediabetes
STMGF
Survey
Lead sponsor: Dacima Consulting
Sponsor class: OTHER
Collaborators: name: Société Tunisienne de Médecine Générale et de Médecine de Famille
First posted: 2025-02-13
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ambulatory patient consulting in primary care in a public or private structure, without patent diabetes

Brief summary: The study is national, observational and cross-sectional and aims to estimate the prevalence of prediabetes in primary care in Tunisia.

Detailed description: TN-PREDIAB is a Tunisian, descriptive, non-interventional, multicenter and cross-sectional clinical study performed in primary care facilities, of both public and private sectors. The study will screen ambulatory patients for at least 4 months to estimate the prevalence of prediabetes among enrolled subjects.

The objectives of the study are:

* Primary objective: to estimate the overall prevalence of prediabetes among Tunisian population
* Secondary objective:
* Describe the clinical and epidemiological profile of prediabetic subjects
* Describe nutritional factors associated with prediabetes

A Scientific Committee validates the scientific writing, a Steering Committee supervises the clinical operations of the project.

Collected data are managed by the DACIMA Clinical Suite®, the electronic data capture platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation).

Eligibility criteria: Inclusion Criteria:

* Ambulatory patient consulting in primary care in a public or private structure

Exclusion Criteria:

* Known diabetes
* Concomitant medication that may influence blood sugar (corticosteroids, metformin, GLP1 analogues, SGLT2 inhibitor)
* Severe, acute or chronic comorbidity (end-stage renal failure, severe liver disease, heart failure)
* Severe anemia
* Pregnancy

Primary outcomes:
measure: Prediabetes
timeFrame: At inclusion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Société Tunisienne de Médecine Générale et de Médecine de Famille
name: Mohamed Haithem Ben Haj Salah, MD
role: STUDY_CHAIR
affiliation: Société Tunisienne de Médecine Générale et de Médecine de Famille
name: Habib Jerbi, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01160133: To Evaluate the Physical Effects of Systane(R) Lubricant Eye Drops Compared to Refresh Tears(R) Lubricant Eye Drops
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Eye
Keywords: Systane
Refresh Tears
Dry Eye
Moderate to Severe Dry Eye
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-07-12
Enrollment: 78
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 is a multi-site, randomized, investigator-masked study to evaluate the physical effects of Systane(R) versus Refresh Tears(R) in subjects with moderate to severe dry eye. It is a 6-week, perspective, randomized, active-controlled, investigator-masked, parallel group study.


Eligibility criteria: Inclusion Criteria:

* Patient must be 18 years of age or older of any sex and any race, with a score of at least 2 (some of the time) on the subject-assessed Symptom Eligibility question.
* A sodium fluorescein corneal staining sum of ≥ 3 in either eye.
* A best-corrected visual acuity of 0.6 logMAR or better in each eye as assessed using an ETDRS chart.

Exclusion Criteria:

* A history or evidence of ocular or intraocular surgery in either eye within the past 6 months.
* Lasik patients can be included if lasik surgery was greater than 6 months prior to the initiation of the study.
* A history of intolerance or hypersensitivity to any component of the study medications.

Primary outcomes:
measure: To evaluate physical effects of Systane and Refresh Tears in subjects to moderate to severe dry eye.
timeFrame: Baseline to visit 3 (Day 42)
Secondary outcomes:
Other outcomes:
Locations:
city: Saidapet
country: India
facility: Vasan Eye Care Hospital
state: Channai
Study officials:
References:
Clinical trial NCT06815133: Effectiveness and Safety of Zilucoplan Treatment for French Patients with Myasthenia Gravis Over 3 Months
Official title: Multicenter Retrospective Study on the Short- and Medium-Term Efficacy and Tolerance of Zilucoplan Therapy in a Cohort of French Patients with Anti-AChR Myasthenia Gravis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Myasthenia Gravis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be selected from all the public hospitals in France where patients with confirmed myasthenia gravis with anti-AChR antibodies are given Zilucoplan as treatment under restricted access

Brief summary: This study called "Multicenter Retrospective Study on the Short- and Medium-Term Efficacy and Tolerance of Zilucoplan Therapy in a Cohort of French Patients with Anti-AChR Myasthenia Gravis", is investigating the effects of a new treatment called Zilucoplan (generic name: ZILBRYSQ) on patients in France with a condition known as myasthenia gravis. Myasthenia gravis is an autoimmune disease that causes muscle weakness that worsens throughout the day with activity and impacts the ability to work and perform daily activities. The study aims to see if Zilucoplan can improve muscle strength and quality of life over three months, while also assessing its tolerance and safety by monitoring side effects. Researchers hope this treatment will offer significant benefits for people with this challenging condition.


Eligibility criteria: Inclusion Criteria:

- Confirmed diagnosis of myasthenia gravis with anti-AChR antibodies in patients treated with Zilucoplan

Exclusion Criteria:

* None

Primary outcomes:
measure: MG-ADL scores
timeFrame: At 1 month and at 3 months
Secondary outcomes:
measure: Garches scale scores
timeFrame: At the Inclusion, at 1 Month and at 3 months
measure: Evaluation of tolerance (M3) through the description of type of Adverse events
timeFrame: At 3 months
measure: Evaluation of tolerance (M3) through the description of the frequency of Adverse event
timeFrame: At 3 months
measure: Adverse events possible association with the treatment (causality)
timeFrame: At 3 months
measure: Quality of life evaluation (MG-QoL15r)
timeFrame: At the inclusion, at 1 Month and at 3 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU NICE
state: Alpes Maritimes
Study officials:
References:
Clinical trial NCT01301833: Long-term Safety Study of MP-513 in Patients With Type 2 Diabetes
Official title: Long-term Safety Study of MP-513 as Monotherapy or in Combination With Oral Antihyperglycaemic Agent in Japanese Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: insulin resistance
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2011-02-23
Enrollment: 462
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of MP-513 (Teneligliptin) as monotherapy or in combination with oral antihyperglycaemic agent in patients with type 2 Diabetes for 52 weeks administration.


Eligibility criteria: Inclusion Criteria:

* Patients who has been receiving a stable dose and regimen of oral antihyperglycaemic agent (biguanide agent,α-glucosidase inhibitor,rapid insulin secretagogue) for diabetes over 12 weeks before administration of investigational drug
* Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug
* Patients whose HbA1c is between 6.5% - 10.0%
* Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug

Exclusion Criteria:

* Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)
* Patients who are accepting treatments of arrhythmias
* Patients with serious diabetic complications
* Patients who are habitual excessive alcohol consumption.
* Patients with severe hepatic disorder or severe renal disorder.
* Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception

Primary outcomes:
measure: Number of Participants With Adverse Events
timeFrame: 52 Weeks
Secondary outcomes:
measure: Change From Baseline in HbA1c at Week 52
timeFrame: Baseline and 52 weeks
measure: Change From Baseline in Fasting Plasma Glucose at Week 52
timeFrame: Baseline and 52 weeks
measure: Change From Baseline in Fasting Glucagon at Week 52
timeFrame: Baseline and 52 weeks
measure: Change From Baseline in Fasting Immuno Reactive Insulin (IRI) at Week 52
timeFrame: Baseline and 52 weeks
Other outcomes:
Locations:
city: Chitose-shi
country: Japan
state: Hokkaidou
Study officials:
affiliation: Tokyo University
name: Takashi Kadowaki, Professor
role: STUDY_DIRECTOR
affiliation: Mitsubishi Tanabe Pharma Corporation
name: Kazuoki Kondo, MD
role: STUDY_DIRECTOR
References:
citation: Kadowaki T, Marubayashi F, Yokota S, Katoh M, Iijima H. Safety and efficacy of teneligliptin in Japanese patients with type 2 diabetes mellitus: a pooled analysis of two Phase III clinical studies. Expert Opin Pharmacother. 2015 May;16(7):971-81. doi: 10.1517/14656566.2015.1032249. Epub 2015 Apr 10.
Clinical trial NCT02159833: Intranasal Diagnostics in Food Allergy: a Feasibility Study
Official title: Phase 1/2 Study to Determine the Intranasal Allergen Threshold to Food Proteins in Children With Food Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Food Allergy
Keywords: Food allergy
Diagnosis
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2014-06-10
Enrollment: 31
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The investigators will conduct low-dose intranasal allergen challenges on children/adolescents with a diagnosis of food allergy to egg/cow's milk/soya/wheat/peanut. The data will be used to determine the safety and potential utility of intranasal food challenges in the diagnosis of food allergy.


Eligibility criteria: Inclusion Criteria:

* Aged 6 - 17 years old
* Physician-diagnosis of food allergy on the basis of:

  * Positive oral food challenge to the causative food (conducted under medical supervision) within the last 12 months; OR
  * History of convincing clinical reaction to the causative food within the last 12 months AND positive skin prick test within last 12 months; OR
  * Evidence of \>95% likelihood of food allergy (on the basis of serum specific IgE or skin prick test (SPT) 8mm or above to the causative food allergen within past 12 months
* Written informed consent from parent/guardian, with assent from children aged 8 years and above wherever possible. Participants aged over 16 years will need to provide their owned informed consent.

Exclusion Criteria:

* Contraindicated as acutely unwell or current unstable asthma:

  * Acute wheeze in last 72 hours requiring treatment
  * Febrile ≥38.0oC in last 72 hours
  * Recent admission to hospital in last 2 weeks for acute asthma
* Current medication

  * Use of asthma reliever medication in last 72 hours
  * Recent administration of a medication containing antihistamine within the last 4 days
  * Current oral steroid for asthma exacerbation or course completed within last 2 weeks

Primary outcomes:
measure: Physiological response to intranasal challenge with a food protein
timeFrame: 20mins
Secondary outcomes:
measure: Intranasal threshold to food protein
timeFrame: 20 mins
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College London / Imperial College Healthcare NHS Trust
Study officials:
affiliation: Imperial College London
name: Paul J Turner, FRACP PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02053233: Robot-assisted Training for Stroke Recovery
Official title: Clinical Trial of Robot-assisted Training for Motor and Gait Recovery in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke
robot-assisted therapy
conventional therapy
motor function
Lead sponsor: Pusan National University
Sponsor class: OTHER
First posted: 2014-02-03
Enrollment: 26
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The robot assisted therapy is one of the new developed technologies for recovery after stroke. This study aimed to evaluating the effect of robotic gait therapy for motor recovery after stroke.

Detailed description: This study designed an assessor-blinded, randomized, controlled clinical study. The participations followed the study protocol and were randomly divided into the control group and Walkbot group. The control group received conventional functional rehabilitation for 40 min/session, 2 sessions/day, 5 days/week for 4 weeks, 40 sessions in all. Whereas the Walkbot group received conventional physical therapy (session I for 40 min/day) companied with Walkbot training (session II for 30 min/day) 5 days a week for 4 weeks, 40 session in all. After 4-week intervention all subjects received conventional physical therapy only, 40 min/day, 5 days/week for 4 weeks. During the test period, general rehabilitation and drug treatment can be done at the same time.

Eligibility criteria: Inclusion Criteria:

* The subjects (age\>19) with stroke 4 weeks after the onset but within 12 months were included.

Exclusion Criteria:

* Participated in the clinical studies, or received the rehabilitation therapy or therapy associated with the rehabilitation for the purpose of motor function improvement within thirty days before the start of this study.
* Cognitive disabilities or serious psychiatric illness.
* Difficulty in walking due to orthopedic problems.
* Ejection fraction less than 30% due to severe heart disease or with a diagnosis of unstable angina.
* Weight more than 135 kg or height less than 150 cm.
* Pregnancy subjects.

Primary outcomes:
measure: function ambulation category (FAC)
timeFrame: within 4 weeks after robot training
Secondary outcomes:
measure: Berg balance scale (BBS)
timeFrame: within 4 weeks after robot training
measure: Korean modified Barthel index (K-MBI)
timeFrame: within 4 weeks after robot training
Other outcomes:
measure: EuroQol-5 dimension (EQ-5D)
timeFrame: within 4 weeks after robot training
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Yong-Il Shin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06796933: Effect of Bioptron on Scar Formation After Cesarean Section
Official title: Effect of Bioptron on Scar Formation After Cesarean Section: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cesarean Section
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-01-28
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study will be to determine the effect of polarized light therapy (Bioptron) on scar formation after a cesarean section.

Detailed description: Cesarean deliveries are among the most frequently performed surgical procedures for women worldwide, with their prevalence increasing globally, especially in developing nations like Egypt.

A scar is a natural outcome of the healing process following a wound. Complaints associated with scars can lead to both physical discomfort and psychological challenges. Enhanced healing of CS scars could lead to better postoperative outcomes, reducing complications such as infection, pain, and restricted mobility. These aspects of recovery are often neglected, as noted by.

This study will be the first to specifically examine the effects of Bioptron light therapy on CS scar formation. While previous research has shown the benefits of this therapy on scars from various operations, none have focused on CS scars. By investigating this innovative, non-invasive treatment approach, the study aims to fill a critical gap in existing research and offer valuable insights into managing and improving postoperative recovery for CS patients.

Eligibility criteria: Inclusion Criteria:

* The participants' ages will be ranged from 20-30 years old.
* Their body mass index (BMI) will not exceed 30 kg/m2.
* They will be primipara and having abdominal scar after CS.
* The scar age will be extended from 6 weeks to 6 months.
* All women will be medically stable when attending the study.

Exclusion Criteria:

* Pregnant women or women planning to become pregnant during the study period.
* Women having diabetes mellitus.
* Women taking immunosuppressant drugs.

Primary outcomes:
measure: The Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: 4 weeks
measure: Vancouver scar scale
timeFrame: 4 weeks
Secondary outcomes:
measure: Adheremeter
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Ghadeer Abdelazim Mostafa
Study officials:
affiliation: Benha University
name: Tamer Assar, Professor
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Mohamed Awad, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT04432233: Intravenous Triple Therapy in the Treatment of Helicobacter Pylori Infection and Related Complications Caused by Active Peptic Ulcer Disease
Official title: Intravenous Administration of Metronidazole, Levofloxacin and Esomeprazole Triple Therapy in the Treatment of Helicobacter Pylori Infection and Related Complications Caused by Active Peptic Ulcer Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Intravenous Drug Usage
Keywords: Helicobacter Pylori Infection
Intravenous Drug Usage
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Helicobacter pylori infection causes active peptic ulcer disease and related complications like bleeding and pyloric obstruction. Usually, clinicians tended to treat Helicobacter pylori infection after active peptic ulcer disease and related complicaitons getting healed, which spent time and money. This study is designed to evaluate the efficacy and safety of intravenous administration of metronidazole, levofloxacin and esomeprazole triple therapy in the treatment of Helicobacter pylori infection combined with peptic ulcer disease related complications.


Eligibility criteria: Inclusion Criteria:

* Male or female aged between 18 and 75 years old
* Without previous Helicobacter pylori treatment
* Diagnosed with active peptic ulcer disease and related complications like bleeding and pyloric obstruction by endoscopy examination
* Ability and willingness to participate in the study and to sign and give informed consent
* Positive for Helicobacter pylori IgM antibody

Exclusion Criteria:

* With previous gastric surgery
* Major systemic diseases
* Pregnancy or lactation
* Allergy to any of the study drugs
* Decline to participate in the study

Primary outcomes:
measure: Helicobacter pylori eradication rate
timeFrame: Six weeks after completion of therapy
Secondary outcomes:
measure: Rate of adverse effects
timeFrame: Within 7 days after completion of therapy
measure: Rate of stop bleeding
timeFrame: Within 7 days after completion of therapy
measure: Rate of pyloric obstruction remission
timeFrame: Within 7 days after completion of therapy
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
state: Shanghai
Study officials:
affiliation: Renji Hospital, School of Medicine, Shanghai Jiao Tong University
name: Hong Lu, PHD,MD
role: PRINCIPAL_INVESTIGATOR
References: