louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03885895: Treatment of Freckles by Intradermal Tranexamic Acid Versus Q Switched KTP Laser.
Official title: Comparative Study for the Treatment of Freckles by Intradermal Tranexamic Acid Versus Q Switched KTP Laser (532nm)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Therapeutic Efficacy
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2019-03-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: Comparative split face study in which 30 patients with freckles are recruited.One side of the face will be treated with Q Switched (QS)KTP 532nm, and the other side will be treated with intradermal tranexamic acid (TXA).

Detailed description: One side of the face will receive QS KTPlaser at a wavelength of 532 nm, spot size 2-3 mm , power 1-1.5J/cm2 and the clinical end point is just frosting.Sessions will be every month for 2 months.

The other side of the face will be assigned to TXA intradermal microinjection in the same session using Kapron 500mg/5ml ampoules (Amoun Pharmaceutical Company), the dose of 1 ml syringe with 100mg/ml. TXA will prepared under sterile conditions. Injections will be applied intradermally on freckles area at.

The sessions of TXA will be every 2 weeks for 2 months.

Postoperatively, topical antibiotic ointment and steriod will be applied. Sunscreen then applied until the next treatment in order to minimize reactive hyperpigmentations.

Follow up after treatment monthly for 2 month.

Eligibility criteria: Inclusion Criteria:

* Both genders
* Age group \> 18years old.

Exclusion Criteria:

* Pregnant and lactating females.
* Keloid and scarring tendancy
* Usage of invasive or semi invasive procedures for treatment of freckles such as chemical peeling , dermaroller..etc. 2 months prior to the study.
* Oral Isotretinoin 6 months prior to the study.
* Active herpetic lesions.
* Any concurrent active skin disease within the treated area.
* Photosensitive skin conditions such as systemic lupus erythematous.
* History of delayed wound healing.
* Bleeding diathesis.
* Medical conditions such as autoimmune diseases.

Primary outcomes:
measure: Pigmentation and severity index by clinical evaluation
timeFrame: 6 months to 1 year
measure: Melanin Index change by spectrophotometer
timeFrame: 6 months to 1 year
measure: Blinded observers' evaluation
timeFrame: 6 months to 1 year
measure: Patient satisfaction rate
timeFrame: 6 months to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr El Ainy university hospital
Study officials:
References:
Clinical trial NCT04924595: Exercise Intervention in Liver Transplant Candidates
Official title: The Effect of a Personalised Training Programme on the Functional Ability and the Quality of Life of Candidates for Liver Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Diseases
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2021-06-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of the study is to investigate the effect of personalised exercise interventions in liver transplant candidates, aiming to prevent or limit sarcopenia and frailty, as well as improving their cardiorespiratory health.


Eligibility criteria: Inclusion Criteria:

* Liver transplant candidates, accepted in the waiting list of the Surgical Department of Transplantation A.U.Th., General Hospital of Thessaloniki "Ippokratio".

Exclusion Criteria:

* Recent (\<12 months) Acute Myocardial Infraction
* Recent (\<12 months) brain strokes
* Uncontrolled and/or untreated arrythmia
* Hepatic encephalopathy
* Bed-bound patient
* Liver Transplantation
* Death

Primary outcomes:
measure: Change from Baseline "Liver Frailty Index" value at 12 weeks
timeFrame: After 12-week exercise intervention
measure: Change from Baseline "6 Minute Walking Test" value at 12 weeks
timeFrame: After 12-week exercise intervention
Secondary outcomes:
measure: VO2max
timeFrame: Before intervention initiation and after 12-week exercise intervention
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: Surgical Department of Transplantation A.U.Th.
state: Thessaloniki
city: Thérmi
country: Greece
facility: Laboratory of Sports Medicine
state: Thessaloniki
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Ilias M Oikonomou, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02294695: Early Procalcitonin Kinetics During Empirical Antibiotic Therapy in Critically Ill Patients
Official title: Early Procalcitonin Kinetics May Indicate Effectiveness of the Empirical Antibiotic Therapy in Sepsis Within Hours
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacterial Infections
Keywords: Empiric antibiotic therapy
Lead sponsor: Szeged University
Sponsor class: OTHER
First posted: 2014-11-19
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients over 18 years with suspected infection on admission or during their stay on the intensive care unit were screened for eligibility. Patients were enrolled, when the attending intensive care specialist had a suspicion of infection and decided to start empirical antibiotic therapy.

Brief summary: To investigate the value of procalcitonin (PCT) kinetics between 0-8-16-24 hours after starting empirical antibiotic therapy in critically ill patients, to predict appropriate or inappropriate antibiotic treatment.


Eligibility criteria: Inclusion Criteria:

* Clinical signs of infection
* Suspected or proven acute infection requiring empiric antibiotic therapy as decided by the attending ICU physician
* Suspected site of infection has to be present and documented
* Microbiological sample sent for staining
* Inflammatory markers available at the start of the therapy

Exclusion Criteria:

* Patients younger than 18 years
* Who received prophylactic or empiric antibiotic therapy 48 hours before inclusion
* Whose receiving acute renal replacement therapy in the first 24 hours following antibiotic treatment
* Following cardiopulmonary resuscitation
* End stage diseases with a "do not resuscitate" order
* Immunocompromised patients (human immunodeficiency virus infection, bone marrow transplantation, malignant haematological disorders and chemotherapy)
* Post cardiac surgery patients

Primary outcomes:
measure: Procalcitonin kinetic
timeFrame: The first six days after starting empiric antibiotic treatment
Secondary outcomes:
measure: Sequential Organ Failure Assessment score
timeFrame: The first six days after starting empiric antibiotic treatment
Other outcomes:
measure: Length of Intensive Care Unit stay
timeFrame: Maximum 90 days after enrollment
measure: Intensive Care Unit mortality
timeFrame: Maximum 90 days after enrollment
measure: Length of hospital stay
timeFrame: Maximum 90 days after enrollment
measure: Hospital mortality
timeFrame: Maximum 90 days after enrollment
Locations:
city: Szeged
country: Hungary
facility: Department of Anaesthesiology and Intensive Therapy
state: Csongrád
Study officials:
References:
Clinical trial NCT04646850: Long-term Treatment With the Ketogenic Diet in Epilepsy
Official title: Long-term Treatment With the Ketogenic Diet in Epilepsy and Epilepsy-related Rare Diseases
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Epilepsy
GLUT1DS1
PDH Deficiency
Keywords: Ketogenic dieting
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2020-11-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with the ketogenic diet (classical or modified) for epilepsy, GLUT1 deficiency or PDHD at The National Centre for Epilepsy - SSE for 5 years or longer.

Brief summary: This study will provide a comprehensive assessment of long-term treatment with the ketogenic diet, a medical diet with high fat and low carbohydrate intake, focusing on safety and cardiovascular implications. We will assess patients with epilepsy or one of two rare metabolic diseases; glucose transporter type 1 deficiency syndrome (GLUT1 DS) or pyruvate dehydrogenase complex deficiency (PDHD).


Eligibility criteria: Inclusion Criteria:

* Treatment with the ketogenic diet at the National Centre for Epilepsy (SSE) for 5 years or more
* Able to travel from The National Centre for Epilepsy - SSE (Sandvika) to Rikshospitalet (Gaustad) to perform procedures to investigate cardiovascular risk factors
* Willing to draw extra blood for research purposes
* Willing to sign informed consent and participate in the study in accordance with the study protocol
* Willing to sign informed consent for blood samples to be included in research biobank at the Department of Neurology, Oslo University Hospital

Exclusion Criteria:

* Non-compliance with the dietary treatment for 6 months or longer or more than once per month
* Not possible to communicate with parents in Norwegian or English without interpreter
* Patient not able to cooperate and lie still for about ten minutes during the carotid ultrasound examination
* Psychiatric/mental illness, alcohol or drug abuse or other factors making it impossible to pursue the study protocol

Primary outcomes:
measure: Cardiovascular risk after long-term treatment with the ketogenic diet
timeFrame: 2018-2022
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Anette Ramm-Pettersen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00390650: A North-American Eight-week Study to Evaluate the Efficacy and Safety of Saredutant in Patients With Generalized Anxiety Disorder
Official title: An Eight-Week, Multicenter, Randomized, Double-blind, Placebo-controlled Study, With Escitalopram as an Active Control, to Evaluate the Efficacy, Safety and Tolerability of a Saredutant 100 mg Dose Once Daily, in Patients With Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anxiety
Keywords: Anxiety
clinical trials
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-10-20
Enrollment: 366
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 primary objective is to evaluate the efficacy of a 100 mg dose of saredutant compared to placebo in patients with generalized anxiety disorder. The secondary objectives are to evaluate the efficacy of saredutant on disability and quality of life in patients with generalized anxiety disorder, and to evaluate blood levels of saredutant.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of generalized anxiety disorder as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) Plus Generalized Anxiety Disorder module.

Exclusion Criteria:

* Total score of less than 22 on the HAM-A.
* Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than 18.
* Patients with a current history (within 6 months) of major depressive disorder or history or presence of bipolar disorders or psychotic disorders.
* Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence.
* Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, antidepressants including Monoamine Oxidase Inhibitors (MAOIs) within 1 month, anxiolytics within 2 weeks, mood-stabilizer (lithium, anticonvulsants) within 1 month, and/or high dose or prolonged benzodiazepine (continuous use for 3 months prior to admission) use.

The investigator will evaluate whether there are other reasons why a patient may not participate.

Primary outcomes:
measure: The primary outcome of the study is the change from baseline to Day 56 of treatment in the Hamilton Anxiety Rating Scale (HAM-A) total score.
Secondary outcomes:
measure: The key secondary efficacy outcome is change from baseline in the Clinical Global Impression Severity of Illness score.
Other outcomes:
Locations:
city: Bridgewater
country: United States
facility: Sanofi-Aventis
state: New Jersey
city: Laval
country: Canada
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Marie TRAD, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06704750: Correlation Between Physical Fitness Status and Quality of Postoperative Recovery in Gynaecological ERAS Patients
Official title: General Gynecology Center
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gynecology
Postoperative Recovery
Enhanced Recovery After Surgery
Six-minute Walk Test
EQ5D5L-VAS
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 146 patients were included in this study, and 114 patients completed full follow-up.The average age of the paticipants was 35.48 years old.

Brief summary: Investigate the current status of perioperative physical fitness.To compare the degree of agreement between the 6-minute walk test and the EQ5D5L-VAS score in assessing recovery after gynecological ERAS, and to provide a reference for a more scientific and comprehensive assessment of patients' physical recovery after gynecological ERAS.

Detailed description: 1. Investigate the current status of perioperative physical fitness and postoperative recovery quality of gynaecological ERAS patients
2. Explore the correlation between the physical fitness status of gynaecological ERAS patients and the quality of postoperative recovery.
3. Based on the correlation between patients' physical fitness status and the quality of postoperative recovery, to further determine the optimal threshold of the 6MWT distance

Eligibility criteria: Inclusion Criteria:

* age 18-50 years old;
* diagnosed with benign gynecological diseases and undergoing laparoscopic surgery;
* acceptance of ERAS modality;
* normal cognitive communication ability and proficiency in the use of smartphones;
* without motor disabilities.

Exclusion Criteria:

* unstable angina and myocardial infarction within 1 month;
* heart rate \>120 beats/minute at rest, systolic blood pressure \>180 mmHg, diastolic blood pressure \>100 mmHg;
* diagnosis of anxiety and depression;
* pregnancy.

Primary outcomes:
measure: Six-minute walk test
timeFrame: since the preoperative period, followed up until the patients' walk test was fully restored to their follow-up preoperative levels,at most 1 month
measure: EQ5D5L-VAS
timeFrame: since the preoperative period, followed up until the patients' walk test was fully restored to their follow-up preoperative levels, at most 1 month
measure: QoR-15
timeFrame: on the preoperative period, on the 1 day of discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences,Peking Union Medical College Hospital
Study officials:
References:
Clinical trial NCT03355950: ASA Levels in TEP and Lichtenstein Repair Patients
Official title: Comparison of Anti-sperm Antibody Levels in Inguinal Hernia Patients Who Undergo Totally Extra-peritoneal and Lichtenstein Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hernia, Inguinal
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 160
Sex: MALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine and compare the possible affects of two different inguinal hernia repair technique (TEP and Lichtenstein) on serum ASA levels.

Detailed description: Antisperm antibody levels are thought to be indirect indicators of spermatic duct injuries. The investigators' ultimate goal is to draw a conclusion about the effect of the type of surgery on spermatic duct integrity. The investigators are going to collect serum samples from inguinal hernia patients before and after surgery. The investigators aim to assess the effect of surgery on antisperm antibody levels of patients who undergo Licthenstein and TEP repair. Preoperative antisperm antibody levels will serve as control levels for each patient group.

Eligibility criteria: Inclusion Criteria:

* to accept the terms of the randomization and all study
* to have unilateral inguinal hernia and set for an inguinal hernia repair
* to be a father

Exclusion Criteria:

* to have any kind of autoimmune disorders
* any kind of infertility history
* to have a history of inguinal and/or genital surgery and/or trauma

Primary outcomes:
measure: Change from baseline Anti-sperm antibody levels after inguinal hernia surgery
timeFrame: Three months for each patient
Secondary outcomes:
measure: Comparison of Anti-sperm antibody levels between inguinal hernia patients who have undergone laparoscopic totally extraperitoneal repair and Lichtenstein repair techniques
timeFrame: 2 years anticipated
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Numune Training and Research Hospital
Study officials:
affiliation: Ankara Numune Research and Training Hospital
name: Faruk Coskun, MD, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT02161146: AGN-229666 Ophthalmic Solution in Japanese Patients With Allergic Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Conjunctivitis, Allergic
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2014-06-11
Enrollment: 240
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the safety and efficacy of AGN-229666 for the prevention of allergen-mediated conjunctivitis.


Eligibility criteria: Inclusion Criteria:

-Japanese patients living in Japan with a history of allergic conjunctivitis.

Exclusion Criteria:

* Presence of active eye infection (bacterial, viral, or fungal)
* History of an eye herpetic infection.

Primary outcomes:
measure: Ocular Itching Score
timeFrame: Days 1 and 15
Secondary outcomes:
measure: Conjunctival Hyperemia Score
timeFrame: Days 1 and 15
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Nakatani H, Gomes P, Bradford R, Guo Q, Safyan E, Hollander DA. Alcaftadine 0.25% versus Olopatadine 0.1% in Preventing Cedar Pollen Allergic Conjunctivitis in Japan: A Randomized Study. Ocul Immunol Inflamm. 2019;27(4):622-631. doi: 10.1080/09273948.2018.1432764. Epub 2018 Mar 15.
Clinical trial NCT06131346: Clinical Characterization and Outcome of Anti-IgLON5 Disease
Official title: Identification, Clinical Characterization, and Prognosis of Anti-IgLON5 Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anti-IgLON5 Disease
Keywords: Anti-IgLON5 disease, autoimmune encephalitis, neural antibodies
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-11-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients tested positive for anti-IgLON5 antibodies.

Brief summary: Anti-IgLON5 disease is a neurological disorder associated with antibodies to IgLON5, a neuronal cell adhesion protein of unknown function. Most patients develop a combination of significant sleep disturbances (non-rapid eye movement (NREM) and rapid eye movement parasomnias with obstructive sleep apnoea), bulbar dysfunction (dysarthria, dysphagia, vocal cord paralysis or episodes of respiratory failure) and gait instability. Early autopsy studies showed deposits of phosphorylated tau protein mainly in neurons of the brainstem tegmentum, suggesting a primary neurodegenerative disease. However, the results of subsequent studies have provided increasing support for an immune-mediated pathogenesis. First, there is a strong association with the human leukocyte antigen (HLA) haplotype DRB1\*10:01-DQB1\*05 : 01, which is present in \~60% of patients (compared to 2% in the normal population); secondly, recent autopsy studies have shown the absence of abnormal tau deposits; and thirdly, in live neurons in culture, IgLON5 antibodies cause irreversible loss of surface IgLON5 clusters and cytoskeletal changes such as dystrophic neurites and axonal bulges. Together, these studies suggest that antibody-mediated disruption of IgLON5 function leads to neurofilament and cytoskeletal alterations that can potentially result in tau accumulation.

Over the last two years, an increase in diagnoses of anti-IgLON5 disease has been observed in the French Reference centre of Autoimmune Encephalitis. This could be related to a better knowledge of the disease, or to other yet unknown factors. Clinical characterisation of these patients is essential to understand the underlying reasons for the increase in diagnoses and to improve knowledge of this disease. Furthermore, the response of these patients to immunosuppressive drugs and the long-term prognosis remain unknown.


Eligibility criteria: Inclusion Criteria:

* Patients \> 18 ans
* Anti-IgLON5 antibody positivity

Exclusion Criteria:

- Lack of clinical data

Primary outcomes:
measure: Prevalence of IGLON5 disorder
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
Study officials:
References: