louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06172530: Observational Study on the Improvement of Dry Eye Syndrome, Treatment Satisfaction, and Intraocular Tolerance With Diquasol Eye Drops
Official title: Observational Study on the Improvement of Dry Eye Syndrome, Treatment Satisfaction, and Intraocular Tolerance With Diquasol Eye Drops and Hyaluron/Hyaluronmax Eye Drops in Patients Over 19 Years Old With Dry Eye Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dry Eye Syndrome
Lead sponsor: Hanlim Pharm. Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-12-15
Enrollment: 2000
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Dry eye syndrom patients aged 19 years or older

Brief summary: This study is to verify the efficacy and safety in the treatment of dry eye syndrome in patients prescribed with Diquasol eye drops as a monotherapy, or in combination with Hyaluron eye drops, or in combination with Hyaluronmax eye drops.

Detailed description: This study is to observe the prescription patterns in routine clinical practice and assess the changes in dry eye symptoms, treatment satisfaction, and intraocular tolerance over a 12-week period in patients prescribed with Diquasol eye drops as a monotherapy or in combination with Hyaluron eye drops or Hyaluronmax eye drops for the treatment of dry eye syndrome.

Eligibility criteria: Inclusion Criteria:

* Adults aged 19 years and older
* Patients with dry eye syndrome with TBUT of 10 or less
* Individuals scheduled to receive either Diquasol eye drops as a monotherapy or a combination therapy of Diquasol eye drops with Hyaluron eye drops or Diquasol eye drops with Hyaluronmax eye drops, based on clinical judgment for the treatment of dry eye syndrome
* Individuals who have voluntarily provided written consent for participation in this study

Exclusion Criteria:

* Pregnant or lactating women
* Individuals contraindicated according to the approval conditions of Diquasol eye drops, Hyaluron eye drops, and Hyaluronmax eye drops
* Cases where the principal investigator or study personnel deem the individual unsuitable for participation in this clinical study

Primary outcomes:
measure: Primary Assessment Variables
timeFrame: after 12 weeks of prescription for Diquasol eye drops and Hyaluron/Hyaluronmax eye drops compared to baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: CK St. Mary's Eye Clinic
Study officials:
affiliation: CK st. Mary's Eye Clinic
name: ChounKi Joo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01522430: Study of Catheter Based Renal Denervation Therapy in Hypertension
Official title: DENERVATION OF RENAL SYMPATHETIC ACTIVITY AND HYPERTENSION STUDY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Resistant Hypertension
Renal Denervation
Ambulatory Blood Pressure
Renal Function
Keywords: Resistant hypertension
Renal denervation
Ambulatory blood pressure
Renal function
Simplicity catheter
Sham procedure
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2012-01-31
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The DEPART study end points are to provide conclusive evidence, using a randomized, double blinded, sham procedure controlled study design, that radiofrequency renal denervation:

1. reduces daytime ambulatory blood pressure,
2. improves nocturnal dipping in blood pressure at the ambulatory blood pressure recording.


Eligibility criteria: Inclusion Criteria:

* They have a mandatory \> 3 antihypertensive medication therapy, including a thiazide or a loop diuretic (according to the patient's renal function, unless documented side-effects) and at least one attempt to treat with spironolactone, given at usual recommended dose since at least 8 weeks, before inclusion,
* A mandatory check list of secondary cause of hypertension has been excluded
* They succeed the pill count test.
* They have a mandatory ambulatory blood pressure monitoring before inclusion with at least 70% of valid readings during daytime (08:00 am 08:00 pm, using a sampling frequency of 20 minutes, only devices validated according to http://www.dableducational.org are permitted), where daytime ambulatory blood pressure of systolic and/or diastolic blood pressure exceeds 135 mmHg and/or 85 mmHg, respectively. Daytime ambulatory blood pressure of systolic and/or diastolic blood pressure below 135 mmHg and/or 85 mmHg, respectively, is acceptable for inclusion in the study if the patient takes four or more antihypertensive medication (3).

Exclusion Criteria:

* Patients with an eGFR \<30ml/min/m² are excluded,
* patients with known renal atherosclerotic lesions,
* previous procedures in the renal arteries,
* known unsuitable anatomy for the procedure,
* previous nephrectomy,
* contrast agent allergy,
* hyperthyroidia.

Primary outcomes:
measure: glomerular filtration rate
timeFrame: 6 month
measure: Ambulatory systolic and diastolic blood pressure
timeFrame: 6 month
Secondary outcomes:
measure: Baroreflex sensitivity
timeFrame: 6 month
measure: Biological markers of acute kidney injury
timeFrame: baseline, H2, H6, 1, 3 and 6 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme Hospital
Study officials:
affiliation: Erasme hospital
name: Jean-François ARGACHA, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01281930: Abscess Packing Versus Wick Placement After Incision and Drainage
Official title: Abscess Packing Versus Wick Placement After Incision and Drainage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Superficial Abscess Packing
Keywords: Superficial abscess
packing material
wick
incision and drainage
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2011-01-24
Enrollment: 156
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Abscesses or "boils" are becoming more common every year and are a common reason children come to the Emergency Department. For the abscess to heal the skin needs to be opened to let the pus come out. Often doctors put something called "packing material" or gauze into the abscess space to help aid in healing. It is not known if the type of "packing" that is done is necessary or if a more simple treatment is as good or better. With informed consent we randomly place a child into one (1) of two (2) groups in this study that will say if the child's abscess/boil is packed with gauze in the traditional way or if a wick (small piece) of gauze is placed after the abscess/boil is opened and the fluid is drained. After treatment in the emergency department the child will be scheduled to follow-up in the Pediatric Acute Wound Service (PAWS) clinic as all other children with this infection are scheduled. At this visit the healing of the wound will be checked by the staff in the clinic and will be scored. With this evaluation of the wound the hypothesis that for a simple superficial (skin) abscess/boil a gauze wick placement into the abscess/boil is as effective as placement of traditional gauze packing.


Eligibility criteria: Inclusion Criteria:

* Well appearing patient
* Abscesses restricted to the superficial areas of the extremities, buttocks, abdominal and thoracic walls, and back
* Patients presenting Saturday-Wednesday

Exclusion Criteria:

* Fever \>38 degrees celsius
* Ill appearing patient
* Underlying immunodeficiency or disorder leading to chronic abscess formation
* Any reason for admission to hospital beyond the need for sedation at the time of follow-up
* Thursday-Friday

Primary outcomes:
measure: Abscess healing based upon clinical criteria and clinical judgement
timeFrame: 24-72 hours
Secondary outcomes:
measure: Pain since abscess drainage
timeFrame: 24-72 hours
measure: Parent/guardian comfort with removing the packing material or wick from the abscess cavity
timeFrame: 24-72 hours
measure: Parent/guardian assessment of the abscess wound at 2 weeks
timeFrame: 2 weeks
measure: Parent/guardian assessment of pus drainage at 2 weeks
timeFrame: 2 weeks
measure: Need for further treatment of same abscess within 2 weeks
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
Study officials:
References:
Clinical trial NCT00676325: Surgical Treatment To Greater Anterior Vaginal Prolapse
Official title: A Randomized Controlled Trial Study, To Compare Colporrhaphy Versus NAZCA TC™ ,Macroporous Polypropylene Mesh, In Surgical Treatment To Greater Anterior Vaginal Prolapse .
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hernia
Cystocele
Keywords: anterior vaginal prolapse
traditional treatment
mesh, graft
NAZCA TC™ POP REPAIR SYSTEM
colporrhaphy
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2008-05-13
Enrollment: 70
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A RCT study to compare traditional colporrhaphy versus polypropylene mesh in treatment of the anterior vaginal wall prolapse.

Detailed description: Seventy patients with greater anterior vaginal prolapse, whit stress incontinence or not, were randomly assigned to either colporrhaphy or polypropylene mesh repair( NAZCA TC™ POP REPAIR SYSTEM) . The primary outcome was recurrent anterior vaginal prolapse, and secondary outcomes were effects on quality of life and sexual symptom scores, operative time, length of hospitalization, and adverse events.

Eligibility criteria: Inclusion Criteria:

* Women 50 years and older with greater anterior vaginal prolapse,whit stress incontinence or not,point (Ba)ics96, below hymenal ring requiring surgical correction were eligible for participation.

Exclusion Criteria:

Patients were excluded if they had:

* Stage 0 or I (ics96) anterior vaginal support
* Declined participation
* Were pregnant or contemplating future pregnancy
* Had prior anterior vaginal prolapse repair with biologic or synthetic graft
* Active or latent systemic infection
* Compromised immune system
* Uncontrolled diabetes mellitus,
* Previous pelvic irradiation or cancer
* Known hypersensitivity to polypropylene.

Primary outcomes:
measure: The primary outcome measure is recurrent anterior vaginal prolapse
timeFrame: 1 year
Secondary outcomes:
measure: Secondary outcomes are, first, operative time (from first incision to closure of last incision), blood loss (preoperative minus postoperative day one hemoglobin), length of hospitalization, adverse events, PQol , FSFI and Dyspareunia .
timeFrame: 1 year
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Sao Paulo Hospital
Study officials:
affiliation: Federal University of São Paulo
name: carlos a del roy, M D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Riccetto C, Miyaoka R, de Fraga R, Barbosa R, Dambros M, Teixeira A, Palma P. Impact of the structure of polypropylene meshes in local tissue reaction: in vivo stereological study. Int Urogynecol J Pelvic Floor Dysfunct. 2008 Aug;19(8):1117-23. doi: 10.1007/s00192-008-0582-2. Epub 2008 Mar 20.
Clinical trial NCT00140725: Lamivudine Plus Interferon Versus Lamivudine For The Treatment Of HBeAg Positive Chronic Hepatitis B Virus (HBV)
Official title: A Randomised Trial of Lamivudine Plus Interferon Versus Lamivudine for the Treatment of HBeAg Positive Chronic Hepatitis B Virus (HBV)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis B
Keywords: HBeAg-positive
chronic
Hepatitis B
lamivudine
seroconversion
Chronic Hepatitis B
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 160
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: TREATMENT

Brief summary: This is a single-centre prospective randomised study comparing the virological and histological response of HBV infection to lamivudine in combination with interferon versus lamivudine alone.


Eligibility criteria: Inclusion criteria:

* Untreated chronic hepatitis B patients with evidence of HBV replication as documented by serum HNV-DNA positive within 3 months prior to entry and serum HBeAg positive at screening.
* Documented presence of abnormal alanine aminotransferase (ALT) (1.3 - 5X upper limit normal (ULN)) within 1 month prior to entry and signs of compensated liver disease.

Exclusion criteria:

* Patients with any cause for liver disease other than chronic hepatitis B and evidence or history of decompensated liver disease.

Primary outcomes:
measure: Proportion of patients with HBeAg seroconversion to anti-HBe
Secondary outcomes:
measure: Normalization of alanine aminotransferase (ALT)
measure: Undetectable HBV DNA
measure: Histologic improvement
measure: Tyrosine, methionine, aspartate, aspartate (YMDD) mutants among the viremic relapsers at the end of therapy and safety of treatment
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06798025: Three Different Modalities for Treatment of Inflammatory Punctal Stenosis
Official title: Comparative Study Between Three Different Modalities for Treatment of Inflammatory Punctal Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Modalities
Treatment
Inflammatory Punctal Stenosis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 60
Sex: ALL
Minimum age (years): 33
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to compare the efficacy of three various modalities of treatment of inflammatory punctal stenosis (Punctal dilatation alone, combined punctal dilatation with topical medications, or peri-punctal injection of Triamcinolone acetonide)

Detailed description: Acquired punctal stenosis is a condition in which the external opening of the lacrimal canaliculus, located in the nasal part of the palpebral margin, is narrowed or occluded. This condition results from chronic inflammation of the external punctum, leading to gradual fibrotic changes in the ostium, followed by progressive occlusion of the duct.

Different modalities were described for the treatment of acquired punctual stenosis. Repeated dilatation of the stenotic punctum is a simple procedure that may provide temporary improvement of the symptoms, but restenosis is common unless additional procedures are performed. Many other methods were used to augment punctual size, including 1-snip, 2-snip, and 3-snip punctoplasty, supplemented with adding sutures or Mini-Monoka insertion and punch punctoplasty.

Eligibility criteria: Inclusion Criteria:

* Age from 33 to 75.
* Both sexes.
* Patients with inflammatory punctal stenosis or occlusion complaining of symptomatic epiphora.

Exclusion Criteria:

* Subjects with previous lacrimal surgeries.
* Subjects with lid margin malposition such as ectropion, entropion, or lid retraction.
* Subjects with medial lid masses obscuring the punctum.
* Subjects with a history of ocular trauma involving the medial aspect of the lid margin.

Primary outcomes:
measure: Degree of patient satisfaction
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: Punctal diameter
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT06011525: Prevention of Alopecia in Patients With Localised Breast Cancer
Official title: Prevention of Alopecia in Patients With Localised Breast Cancer by Scalp cooLing vs Cooling Mask: a Randomised Controlled Trial With Medico-economic Evaluation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chemotherapy-induced Alopecia
Keywords: alopecia
chemotherapy-induced
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 196
Sex: FEMALE
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The prevention of chemotherapy-induced alopecia (CIA) is still imperfectly managed in France. Strengthening the evidence base on the benefits of strategies to prevent CIA, based on robust methodologies, remains a prerequisite for better integration of appropriate supportive care for patients receiving chemotherapy.

This research should provide new knowledge on the benefits of scalp refrigeration during anthracycline- and taxane-based chemotherapy in preventing ACI, for each of the 2 refrigeration techniques. In addition to effectiveness in preventing ACI, quality of life, self-image and satisfaction with care will be assessed by patients during and after chemotherapy. The medico-economic aspects will also be assessed for each of the two refrigeration modalities. The results of the various proposed assessments will be used to guide the choice between these two techniques for preventing ACI.


Eligibility criteria: Inclusion Criteria:

* Age \>18
* Female
* Histologically proven diagnosis of localised, non-metastatic breast cancer
* Indication for neo-adjuvant or adjuvant anthracycline and taxane chemotherapy (3 EC100 followed by 3 Docetaxel or 3 EC100 plus 12 Paclitaxel); HER-positive status is not a non-inclusion criterion.
* Patient willing to be photographed to assess IFA
* Fluency in French
* Patient affiliated to a social security scheme
* Signature of informed consent

Exclusion Criteria:

* History of neck pain
* Pre-existing alopecia
* Participation in another trial
* Dermatosis of the scalp
* Contraindication to scalp cooling
* History of migraines, stroke or hyperthyroidism
* History of scalp metastases
* Sensitivity to cold, cold agglutinin disease, cryoglobulinaemia, cryofibrinogenaemia or post-traumatic cold dystrophy.
* Malignant haemopathies
* History of chemotherapy treatment
* Indication for cerebral irradiation
* Pregnant or breast-feeding patient
* Raynaud's syndrome

Primary outcomes:
measure: Compare the grade of the patient alopecia.
timeFrame: At 6 months after treatment start
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: centre François Baclesse
city: Lille
country: France
facility: Centre Oscar Lambret
Study officials:
References:
Clinical trial NCT02205125: Cold Polypectomy Site Study
Official title: Prospective Characterization of the Mucosal Defect After Cold Snare Polypectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colonic Polyps
Keywords: polyp
colon
polypectomy
snare
Lead sponsor: Western Sydney Local Health District
Sponsor class: OTHER
First posted: 2014-07-31
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing colonoscopy at a tertiary endoscopy unit.

Brief summary: Removal of polyps at colonoscopy reduces colon cancer. Snare polypectomy is the conventional method for removal however the snared area after removal can occasionally appear uneven raising the possibility that complete removal has not occurred. The significance of this irregularity has not be studied. This study aims to separately sample the irregular area and determine the constituents while recording how frequently this occurs during routine colonoscopy and polypectomy. We hypothesize that the irregular areas are submucosal tissue and do not represent polyp tissue left behind.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing colonoscopy with at least one polyp identified where polypectomy is planned.

Exclusion Criteria:

* Age \< 18 years
* Patients where polypectomy is not planned to be undertaken (patients scheduled for diagnostic colonoscopy only).

Primary outcomes:
measure: Frequency and constituents of stalk projections in cold snare polypectomy sites
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Westmead Hospital Endoscopy Unit
state: New South Wales
Study officials:
affiliation: WSLHD
name: Michael Bourke, MBBS, FRACP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06604325: Prophylactic Tranexamic Acid To Reduce Blood Loss During Caesarean Delivery.
Official title: Prophylactic Role Of Tranexamic Acid To Reduce Blood Loss During Caesarean Delivery : A Prospective Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Partum Hemorrhage
Lead sponsor: Aligarh Muslim University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postpartum hemorrhage continues to be the leading cause of maternal morbidity and mortality. Globally, it is responsible for 25% of all pregnancy-related deaths. PPH is unpredictable and may occur in the absence of risk factors. Tranexamic acid is an antifibrinolytic proven to reduce blood loss and transfusion requirements for various surgeries. This study aims to explore the effectiveness of tranexamic acid as an adjunct to other uterotonics before the Caesarian Section.


Eligibility criteria: Inclusion Criteria:

1. The women undergoing cesarean delivery (both elective and emergency) during the study period.
2. Willing to participate in the study after understanding the concept.

Exclusion Criteria:

1. Critically ill patient.
2. Not willing to give consent to participate in the study
3. Cases diagnosed with a ruptured uterus or undergoing caesarian hysterectomy during operation.

Primary outcomes:
measure: Perioperative blood loss
timeFrame: Amount of blood loss from starting from surgical incision till 24 hours post caesarean section.
Secondary outcomes:
Other outcomes:
Locations:
city: Fatehpur
country: India
facility: ASJSATDS Medical College
state: Uttar Pradesh
Study officials:
affiliation: AMU
name: MUAZZAM HASAN, MD
role: PRINCIPAL_INVESTIGATOR
References: