louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02889185: Multimodal Imaging in Central Serous Chorioretinopathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Central Serous Chorioretinopathy
Keywords: Optical Coherence Tomography
Retinal camera
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-09-05
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims to assess the contribution of the multimodal imaging, combining a routine examination using Optical Coherence Tomography (OCT) with an imaging procedure using adaptive optics retinal camera.

This is a feasibility study with a limited number of patients.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent form
* Beneficiary/affiliated to French social security/social healthcare
* Active ou chronic Central Serous Chorioretinopathy on at least one eye
* Absence of other known ophthalmological pathology or of any ophthalmological conditions revealed during the examination

Exclusion Criteria:

* Legal incapacity or limited legal capacity
* Predictable poor adherence
* Subject without health insurance
* Pregnant or breatfeeding women
* Sujet étant dans la période d'exclusion d'une autre étude ou prévue par le "fichier national des volontaires"
* Presence of transparent medium opacity damaging images quality
* Previous photosensitivity
* Recent treatment with PhotoDynamic Therapy (PDT)
* Use of drugs inducing photosensitivity

Primary outcomes:
measure: Workability of images of RTX1 IMAGIN EYE retinal camera
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU Besançon
Study officials:
affiliation: CHU Besançon
name: Maher Saleh, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00788385: Multi-Center Study of ShuntCheck
Official title: Multi-Center Study of ShuntCheck
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Blocked Ventricular Shunts
Keywords: Hydrocephalus
High Pressure
Shunt Blockage
Lead sponsor: NeuroDx Development
Sponsor class: INDUSTRY
First posted: 2008-11-10
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Multi-Center Study of ShuntCheck


Eligibility criteria: Inclusion Criteria:

Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02932085: Pilot Study for the Effects of Transcranial Magnetic Stimulation on the Brain Using an Electronic Medical Device
Official title: Pilot Study for the Effects of Transcranial Magnetic Stimulation on the Brain Using an Electronic Medical Device: A Single Institution, Randomized, Double-blind, Sham-controlled Study Using Multimodal Neuroimaging in Healthy Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Transcranial magnetic stimulation
Magnetic resonance imaging
Magnetic resonance spectroscopy
Lead sponsor: Ewha Womans University Mokdong Hospital
Sponsor class: OTHER
First posted: 2016-10-13
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is a randomized, double-blind, and sham-controlled trial to examine the effects of transcranial magnetic stimulation on the brain of health individuals.

Detailed description: The efficacy of repetitive transcranial magnetic stimulation on the brain will be assessed by multimodal neuroimaging in healthy individuals.

Eligibility criteria: Inclusion Criteria:

* Aged 19-39 years
* Informed consent

Exclusion Criteria:

* Pregnancy or breastfeeding
* High fever patient
* Current and past history of seizure or epilepsy
* Evidence of epilepsy on EEG
* Pregnancy or possibility of pregnancy during period
* Major medical or neurological illnesses
* Evidence of alcohol intake on alcohol breath test
* Contraindications to MRI scans and transcranial magnetic stimulation
* Risk of skin burns
* Use of medications that could have influenced on the study

Primary outcomes:
measure: Metabolic brain changes in magnetic resonance imaging by computational approaches
timeFrame: after 5 sessions (1 session/day) equals 5 days
Secondary outcomes:
measure: Functional brain changes in magnetic resonance imaging by computational approaches
timeFrame: after 5 sessions (1 session/day) equals 5 days
measure: Standardized scores on a neuropsychological test battery
timeFrame: after 5 sessions (1 session/day) equals 5 days
measure: Analysis of EEG activity
timeFrame: after 5 sessions (1 session/day) equals 5 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
Study officials:
References:
citation: Hong H, Kim RY, Song Y, Suh C, Lee H, Lyoo IK, Yoon S, Lim SM, Lee S. Genetic profile for dopamine signaling predicts brain functional reactivity to repetitive transcranial magnetic stimulation. Eur Arch Psychiatry Clin Neurosci. 2023 Feb;273(1):99-111. doi: 10.1007/s00406-022-01436-2. Epub 2022 Aug 11.
Clinical trial NCT01842685: Bladder Thermal Distention for Patients With Refractory Overactive Bladder
Official title: Bladder Thermal Distention for Patients With Refractory Overactive Bladder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Overactive Bladder
Keywords: Overactive Bladder
Bladder Distention
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2013-04-30
Enrollment: 20
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: In this study, the investigators will evaluate the efficacy of Bladder Thermal Distention (BTD) in patients with overactive bladder syndrome who failed previous treatment of anticholinergic drugs.

The investigators' hypothesis is that it will improve the storage symptoms.

Detailed description: Inclusion criteria:

1. Patients with overactive bladder syndrome
2. Detrusor Overactivity proven in urodynamic test

Exclusion criteria:

1. Mixed urinary incontinence
2. Active urinary tract infection
3. Urethral Stricture

Outcome measures:

1. Bladder Diaries
2. Urgency questionnaire

Eligibility criteria: Inclusion Criteria:

* Patients with overactive bladder syndrome
* Detrusor Overactivity proven in urodynamic test

Exclusion criteria:

* Mixed urinary incontinence
* Active urinary tract infection
* Urethral Stricture

Primary outcomes:
measure: Urgency Questionnaire
timeFrame: up to 1 year
Secondary outcomes:
measure: Daily frequency of micturitions on Bladder Diary
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Tel Aviv Region
country: Israel
facility: Assaf Harofe MC
state: Zeriffin
Study officials:
affiliation: Assaf Harofe MC
name: Kobi Stav, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02536885: The Effect of Blood Pressure on the Postoperative Cognitive Dysfunction
Official title: The Effect of the Perioperative Blood Pressure on the Onset of Postoperative Cognitive Dysfunction in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Postoperative cognitive dysfunction
Blood pressure
Anesthesia
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
First posted: 2015-09-01
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Permanent and temporary cognitive impairment in the perioperative period is of great importance to patients. Hypoperfusion due to the intraoperative hypotension is often mentioned as a possible cause of postoperative cognitive dysfunction.

Detailed description: All patients aged above 60 years undergoing planned spinal surgery in the prone position in the duration of 1-3 hours under general anesthesia will be included in the study. In group L (liberal), the value of blood pressure will be corrected with the change of mean arterial pressure (MAP) ± 25% patient's mean arterial pressure, and group R (restrictive) with the change of MAP ± 10%. Cognitive dysfunction tests will be executed on the day before the surgery, two hours after the surgery and on the third postoperative day. Anesthesia will be managed according to the standardised protocol. Concentration of desflurane will be adjusted according to entropy values (target 40-50). Analgetics will be applied according to surgical pleth index (SPI) values. Sufentanil will not be applied in the last 15 minutes. Extubation will be performed at the operating theatre when meeting all extubation criteria including train of four ratio (TOFR) above 92%. Neither syntophyllin, nor pharmacological decurarization (syntostigmin) will be applied to the patients.

Eligibility criteria: Inclusion Criteria:

* GCS 15
* ASA risk I - III
* planned spinal surgery in the prone position
* duration of the procedure of 1-3 hours

Exclusion Criteria:

* hypertension above 180/100 torr preoperatively
* blood pressure below 130/80 torr preoperatively

Primary outcomes:
measure: Change in cognitive behavior
timeFrame: within the first 3 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Hradec Kralove
country: Czechia
facility: University Hospital Hradec Kralove
Study officials:
affiliation: University Hospital Hradec Kralove
name: Vlasta Dostalova, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05395585: The Effect of Placental Spontaneous Delivery Versus Manual Removal on Blood Loss During Cesarean Section. A Comparative Study
Official title: The Effect of Placental Spontaneous Delivery Versus Manual Removal on Blood Loss During Cesarean Section. A Comparative Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section Complications
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-05-27
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The mode of placental delivery may contribute to an increase or decrease in the morbidity associated with CS, and many studies have shown it to be a key role in determining the blood loss during CS. Manual removal of the placenta has been implicated in increased blood loss during CS. However, other researchers concluded that it had no detrimental effect on blood loss


Eligibility criteria: Inclusion Criteria:

* Age (18 - 35) years.
* Primigravida.
* Unscarred uterus.
* Singleton pregnancy.
* Living baby.
* Body mass index (18 - 30) 37-40 weeks

Exclusion Criteria:

* Emergency cesarean section due to possibility of maternal distress and blood loss.
* Cesarean hysterectomy as the placenta will be removed with the uterus.
* Abnormally adherent placenta: Placenta accrete, percreta or placenta previa due to failure of placental separation.
* Previous cesarean section as the previous scar may affect placental separation.
* Body mass index less than 18 and more than 30 as extremes of body weight may be associated with increased risks of anemia, bleeding and/or infection.
* Suspected chorioamnionitis to decrease the risk of disseminated infection.
* Bleeding disorders to decrease blood loss.
* Multiple pregnancy due to larger placental volume and blood loss compared with singleton.
* Any pelvic surgery (Appendix - Ovarian cyst. - Ectopic Pregnancy - pelvic abscess)
* Women with medical illness e.g. pre-eclampsia, anemia (Hb less than 11 gm/dl), DM, Cardiac, Renal ...etc. to decrease the risk of maternal morbidity.

Primary outcomes:
measure: Blood loss
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
state: Cairo/القاهرة
Study officials:
affiliation: Ain Shams University
name: Maii Nawara
role: STUDY_DIRECTOR
References:
Clinical trial NCT05069285: A Self-help Book for Insomnia Compared With Sleep Hygiene Advice in Patients Using Sleep Medications
Official title: A Randomized Controlled Trial Comparing a Self-help Book Focusing on Cognitive Behavioral Therapy for Insomnia With Standard Sleep Hygiene Advice Among Patients Using Hypnotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypnotic; Sleep Disorder
Lead sponsor: University of Bergen
Sponsor class: OTHER
First posted: 2021-10-06
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim is to assess whether a self-help book for insomnia will improve sleep and reduce hypnotic use among patients on sleep medications.

Detailed description: This study is a randomized controlled trial evaluating the effect of a self-help book for insomnia compared to the effect of sleep hygiene advice in patients using sleep medications. 150 patients will be randomized to receive either the book (75 patients) or the sleep hygiene advice (75 patients). Patients will fill questionnaires about sleep and health problems at baseline and after 3-6 months after receiving the written material. The main aims are to assess whether a self-help book is more effective in reducing sleep medication use and sleep problems.

Eligibility criteria: Inclusion Criteria:

- Use of sleep medications on prescription or OTC during the last 6 months

Exclusion Criteria:

- Below 18 years of age

Primary outcomes:
measure: Use of hypnotics assessed as days per week
timeFrame: 3-6 months
measure: Insomnia severity assessed with Insomnia Severity Index
timeFrame: 3-6 months
measure: Insomnia severity assessed with Bergen Insomnia Scale
timeFrame: 3-6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: University of Bergen
state: Vestland
Study officials:
affiliation: University of Bergen
name: Bjørn Bjorvatn, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04687956: Primary Surgical Prevention of Breast Cancer-related Lymphedema
Official title: Effect of Lymphatic Microsurgical Preventing Healing Approach (LYMPHA) for Primary Surgical Prevention of Breast Cancer-related Lymphedema
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lymphedema
Mastectomy
Breast Cancer
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2020-12-29
Enrollment: 72
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Lymphedema refers to edema caused by insufficient drainage of interstitial fluid through the lymphatic circulation system. It occurs mainly in the upper and lower extremities and causes chronic inflammation, and finally fibrous adipose tissue is replaced. In this study, the'LYMPHA' (Lymphatic microsurgical preventing healing approach) procedure, which connects lymphatic vessels drained from the arm to the side branches of the axillary vein, contributes to the prevention of lymphedema in patients undergoing axillary lymph node dissection for breast cancer. Investigator aim to help patients' quality of life by prospectively analyzing the effects and applying them to clinical practice, reducing the incidence of lymphedema.

Detailed description: Patients in the LYMPHA group undergo Axillary reverse mapping before the start of surgery, and after axillary lymph node resection, LYMPHA procedure is performed in which the lymphatic vessels drained from the arm and the axillary vein are micro-bonded to the side branches.

Eligibility criteria: Inclusion Criteria:

1. Age over 19 years old
2. Patients who are expected to undergo surgery under the diagnosis of breast cancer, and are determined to undergo axillary lymph node dissection before surgery.

Exclusion Criteria:

1. Patients with vascular and lymph-related diseases
2. Patients with a history of surgical treatment or trauma to both arms and axillary
3. Patients with a history of receiving radiation treatment in both arms, chest, and axilla
4. Patients with confirmed systemic metastasis with stage 4 breast cancer
5. Pregnant and lactating patients

Primary outcomes:
measure: Incidence of lymphedema
timeFrame: 2 years after surgery
Secondary outcomes:
measure: UEL index
timeFrame: 2 years after surgery
measure: Changes in Lymphoscintigraphy
timeFrame: 2 years after surgery
measure: Incidence of lymphedema
timeFrame: 5 years after surgery
measure: 5-year recurrence rate
timeFrame: 5 years after surgery
measure: 5-year overall survival rate
timeFrame: 5 years after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT01478256: Comparative Study in the Efficacy of Topical Besifloxocin With Erythromycin for the Management of Acute Blepharitis
Official title: A Comparative Study in the Clinical and Microbial Efficacy of Topical Besifloxocin Ophthalmic Suspension 0.6% With Erythromycin Ophthalmic Ointment 0.5% BID for the Management of Acute Blepharitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blepharitis
Keywords: blepharitis
topical erythromycin
topical besifloxocin
Lead sponsor: John, George, M.D.
Sponsor class: INDUSTRY
Collaborators: name: Bausch & Lomb Incorporated
First posted: 2011-11-23
Enrollment: 30
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 study looks at the improvements in signs and symptoms in patients with inflammation of the lids, blepharitis, using two different FDA approved topical antibiotic agents, Besifloxocin and Erythromycin. It also evaluates the bacterial cultures in these patients for microbiologic evidence of improvement.

Detailed description: This is a pilot project involving thirty patients with a specific form of inflammtion of the lids called anterior blepharitis. The patients are graded for their signs a symptoms and then randomized to receive either topical Besifloxocin or Erythromycin in addition to standard lid hygiene measures. All patients have cultures of their eyelids performed prior to initiating therapy and are followed for four weeks. The antibiotics are used for two weeks following which repeat cultures of the lids are obtained. The patients are followed for one additional week to ensure that there is no recurrence of their symptoms once the antibiotics are discontinued.

Only adult patients (age 18-100)and women who are not of child bearing potential are included in this study. Then patients have to have symptoms and signs of the disease, blepharitis. Patient who are on unstable antibiotic or steroid regimens and those who cannot discontinue contact lens use are not included in this study.

Eligibility criteria: Inclusion Criteria:Acute blepharitis, age 18-100, Signs and symptoms of blepharitis -

Exclusion Criteria: women of child bearing potential, eye surgery within three months of study, contact lens wear, use of topical or antibacterial agents in past two weeks, use of topical or oral steroids in past two weeks unless stable dosage

-

Primary outcomes:
measure: Improvement in Signs and Symptoms of Blepharitis
timeFrame: Four weeks
Secondary outcomes:
measure: Evaluate Improvement of Bacterial Cultures With Two Different Topical Antibiotics
timeFrame: Three weeks
Other outcomes:
Locations:
city: Louisville
country: United States
facility: George John, M.D.
state: Kentucky
Study officials:
References:
Clinical trial NCT05760456: Safety and Efficacy of DIDALA Monotherapy in Patients With Type 2 Diabetes Compared With Metformin.
Official title: An Open-label, Randomized, Parallel-controlled Study to Evaluate the Safety and Efficacy of DIDALA Monotherapy in Patients With Type 2 Diabetes Compared With Metformin
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Centre of Clinical Pharmacology, Hanoi Medical University
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 140
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 an open-label, two-group parallel study, comparing before and after treatment within the same group and between the two groups. This study is designed to collect data on the safety and efficacy of a marketed pharmaceutical product (DIDALA) compared with Metformin. The efficacy data of DIDALA will be directly compared with Metformin 1000mg/day monotherapy in this study.


Eligibility criteria: Inclusion Criteria:

* 18 years or older at the time of enrollment in the study.
* Diagnosed with type 2 diabetes according to the Guidelines for the diagnosis of type 2 diabetes of the Ministry of Health (2011).
* Fasting blood glucose ≤ 10.0 mmol/L.
* No previous treatment with metformin or other antidiabetic drugs.
* Ability and willingness to provide written informed consent and comply with the protocol's requirements.
* Subject who, in the judgment of the Investigator, is likely to be compliant or cooperative during the study.

Exclusion Criteria:

* The patient has been diagnosed with diabetes and has been previously treated with metformin or other antidiabetic agents.
* Patients with indications for insulin therapy or combination therapy of two or more drugs according to the guidelines for diagnosis and treatment of type 2 diabetes of the Ministry of Health.
* Pregnancy or lactation.
* Patients with contraindications to Metformin include severe liver and/or kidney disease, congestive heart failure, cardiovascular collapse, acute myocardial infarction, severe infection, and sepsis.
* Patients with conditions and circumstances that, in the investigator's opinion, are difficult to ensure adherence to study protocol.

Primary outcomes:
measure: Change from Baseline at Week 12 in Hemoglobin A1c (HbA1c)
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from Baseline at Week 12 in Fasting Plasma Glucose
timeFrame: 12 weeks
measure: Safety assessments
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Hanoi Hospital of Traditional Medical
city: Hanoi
country: Vietnam
facility: National Hospital of Traditional Medicine
Study officials:
References: