louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01348321: Comparison of Efficacy of Azithromycin and Levamisole Versus of Azithromycin in in the Treatment of Acne
Official title: Superior Efficacy of Azithromycin and Levamisole Versus of Azithromycin Alone in the Treatment of Inflammatory Acne Vulgaris: An Investigator Blind Randomized Clinical Trial on 169 Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acne
Lead sponsor: Ahvaz Jundishapur University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-05-05
Enrollment: 169
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Different immunologic mechanisms contribute to development of inflammation in acne vulgaris and immunologic effect of levamisole has been demonstrated.

Objective: The aim of this study was to compare azithromycin and levamisole with azithromycin alone in the treatment of acne vulgaris.

Detailed description: An investigator blind clinical randomized prospective two months study was designed. One hundred sixty nine acne patients presenting in our outpatients clinic were randomly allocated to two treatment groups: azithromycin and levamisole ( group 1 ) and azithromycin alone ( group 2 ) .One hundred forty eight patients completed the duration of the study and their clinical responses were evaluated and compared by using monthly photographic records .

Eligibility criteria: Inclusion Criteria:

1. Patients who had at least 20 papules and/or pustules,
2. Patients with nodule and/or cyst disregarding the number of papules of pustules, were included the study. There was not any age limit

Exclusion Criteria:

1. were using any type of systemic treatment for their acne at the time of visit or during the last month;
2. had any hematological, renal or hepatic disease
3. were pregnant or lactating;
4. had drug-induced acne;
5. were using alcohol, anti-convulsants or anti-coagulants.

Primary outcomes:
measure: Number of Participants with Adverse Events
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Ahvaz
country: Iran, Islamic Republic of
facility: Azadegan Street,Imam Hospital,Department of Dermatology
state: Khoozestan
Study officials:
affiliation: Jundishapur University of Medical Sciences
name: Sima Rasaii, Dermtologist
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haneke E. [Levamisole treatment of acne fulminans (author's transl)]. Z Hautkr. 1981 Sep 1;56(17):1160-6. German.
citation: Ansarin H, Savabynasab S, Behzadi AH, Sadigh N, Hasanloo J. Doxycycline plus levamisole: combination treatment for severe nodulocystic acne. J Drugs Dermatol. 2008 Aug;7(8):737-40.
citation: Rassai S, Mehri M, Yaghoobi R, Sina N, Mohebbipour A, Feily A. Superior efficacy of azithromycin and levamisole vs. azithromycin in the treatment of inflammatory acne vulgaris: an investigator blind randomized clinical trial on 169 patients. Int J Clin Pharmacol Ther. 2013 Jun;51(6):490-4. doi: 10.5414/CP201861.
Clinical trial NCT00775021: A Clinical Comparison of Two Daily Disposable Contact Lenses.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2008-10-17
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the clinical performance of two daily disposable contact lenses.


Eligibility criteria: Inclusion Criteria:

* Age: 18 years to 45 years
* Current daily soft contact lens as habitual optical correction:
* Refraction:

  * Best sphere (corrected for back vertex distance) -1.00 to -6.00D
  * Cylinder 0.00 to - 0.75D
* Best spectacle corrected visual acuity of 6/9 or better in each eye
* Willingness to adhere to the instructions set in the clinical protocol
* Signature of the subject on the informed consent form

Exclusion Criteria:

* Systemic or ocular allergies which might interfere with contact lens wear
* Systemic disease which might interfere with contact lens wear
* Ocular disease which might interfere with contact lens wear (e.g. hypoesthesia, insufficient lacrimal secretion)
* Use of medication which might interfere with contact lens wear
* Active ocular infection
* Use of ocular medication
* Significant ocular anomaly
* Presence of two or more corneal scars in either eye
* Pregnancy or lactation
* Any medical condition that might be prejudicial to the study
* Participated in any other clinical studies in the past month
* Currently wears monovision

Primary outcomes:
measure: Overall Comfort
timeFrame: 1 week
Secondary outcomes:
measure: Inferior Region Corneal Staining
timeFrame: 1 week
measure: End of the Day Comfort
timeFrame: 1 week
measure: Initial Comfort
timeFrame: 1 Week
measure: Overall Lens Handling
timeFrame: 1 week
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Otometry Technology Group, Ltd.
Study officials:
References:
Clinical trial NCT06077721: Milrinone on Right Ventricular Strain in Cardiac Surgery
Official title: Effect of Milrinone on the Right Ventricular Strain in Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischemic Heart Disease
Valvular Heart Disease
Keywords: Milrinone
strain
systolic function
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 41
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: valvular heart disease, coronary heart disease

Brief summary: The purpose of this study is to analyze the changes in right ventricular strain before and after milrinone administration in order to find out whether milrinone improves RV systolic performance in patients undergoing cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* patient agree and provide written informed consent.
* patient undergoing elective cardiac surgery
* preoperative LV EF\>50% (TTE)

Exclusion Criteria:

* preoperative cardiac dysrhythmia
* preoperative IABP
* use of other inotropic agents

Primary outcomes:
measure: 1. Right ventricular strain
timeFrame: 15 min after milrinone administration
Secondary outcomes:
measure: Left ventricular strain
timeFrame: 15 min after milrinone administration
measure: Left ventricular ejection fraction
timeFrame: 15 min after milrinone administration
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
Study officials:
affiliation: Konkuk University Medical Center
name: Soi Lee
role: STUDY_DIRECTOR
References:
Clinical trial NCT06279221: Litfulo Capsules Special Investigation
Official title: Litfulo® Capsules Special Investigation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Alopecia Areata
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2024-02-28
Enrollment: 191
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with alopecia areata who received LITFULO

Brief summary: The objective of this Study is to confirm the safety during the long-term use of this drug and the effectiveness during the use of this drug under the actual use in the patients treated with this drug.

Detailed description: This study is an open-label, multi-center, one arm prospective observational cohort study of patients receiving this drug. The investigators complete the CRF based on the information extracted from the medical record created in daily medical practice.

Eligibility criteria: Inclusion Criteria:

Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:

* Patients with alopecia areata who start receiving this drug for the first time after the contract date of this study
* Patients who have not participated in a clinical trial (clinical study) of this drug

Exclusion Criteria:

Patients meeting any of the following criteria will not be included in the study:

* Patients previously enrolled in this study
* Patients with a history of treatment with this drug (including investigational product)

Primary outcomes:
measure: Proportion of participants with adverse events (AEs)
timeFrame: Baseline through year 3
measure: Percentage of patients achieving SALT≤20 [SALT score (absolute value) 20 or less]
timeFrame: Baseline, evaluation at Week 12, Week 24 , Week 48, Week 78 , Week 104 , Week 130 , and Week 156 after the start of administration.
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04573621: Pelvic Drain After Rectal Resection for Mid-low Rectal Cancer
Official title: Pelvic Drain After Rectal Resection for Mid-low Rectal Cancer: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 518
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This RCT aims at assessing the effects of a pelvic drain after total mesorectal excision for mid-low rectal cancer on the rates of pelvic sepsis and anastomotic leaks.

Detailed description: This is a 2-arm, non-inferiority RCT. Patients undergoing total mesorectal excision for mid-low rectal cancer will be randomly assigned into two groups:

* pelvic drain
* no pelvic drain. Patients will be followed-up to assess the rates of anastomotic leaks, pelvic sepsis and secondary outcomes.

Eligibility criteria: Inclusion Criteria:

* Male or Female, 18 year-of-age or above
* Mid or low rectal cancer
* Anastomosis below the peritoneal reflection
* Total mesorectal excision (TME)
* Capability to understand the study
* Informed consent

Exclusion Criteria:

* For women, pregnancy
* Chronic kidney failure or hepatic failure, immunodepression, malnoutrition
* Life expectancy \< 6 months
* Partial mesorectal excision
* Abdominoperineal excision
* Multivisceral resections
* Emergency surgery

Primary outcomes:
measure: Number of participants with pelvic sepsis
timeFrame: 0-30 days postoperatively
Secondary outcomes:
measure: Management of pelvic sepsis
timeFrame: 0-30 days postoperatively
measure: Postoperative complications
timeFrame: 0-30 days postoperatively
measure: CT scan or imaging needed
timeFrame: 0-30 days postoperatively
measure: Number of participants with postoperative ileus
timeFrame: 0-30 days postoperatively
measure: Diagnostic delay for a leak
timeFrame: 0-30 days postoperatively
measure: Length of postperative stay
timeFrame: 0-30 days postoperatively or until discharge
measure: Time to flatus and bowel movement
timeFrame: 0-30 days postoperatively
measure: Stoma presence at 1-year follow-up
timeFrame: 12 months after surgery
measure: Late pelvic collections
timeFrame: up to 60 days after surgery
measure: Small bowel obstruction
timeFrame: up to 60 days after surgery
measure: Quality of life associated with a drain
timeFrame: 30 days postoperatively
measure: Any complications associated with drain removal after surgery
timeFrame: up to 60 days after surgery
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital General Universitario Vall d´Hebron
state: Barcelona, Spain
Study officials:
References:
Clinical trial NCT01265121: Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism.
Official title: Sleep Apnea Syndrome on Acromegaly: Impact of the Treatment on the Carbohydrates Metabolism.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acromegaly
Obstructive Sleep Apnea
Insulin Resistance
Keywords: Acromegaly
Insulin resistance
Euglycemic Clamp
Somatostatin analogues
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: InCor Heart Institute
First posted: 2010-12-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Sleep apnea is a common situation that affects up to 80% of acromegalic patients. This disease is linked to disturbance on the carbohydrate metabolism increasing the rates of diabetes. The objective of this trial is to assess (with the euglycemic hyperinsulinemic clamp) the impact of the treatment of sleep apnea, with a continuous positive air pressure device (CPAP), on the insulin resistance.


Eligibility criteria: Inclusion Criteria:

* Acromegalic patients
* Moderate to severe sleep apnea
* Using somatostatin analogues at maximum dosage possible for at least 6 month

Exclusion Criteria:

* Unstable angina or high risk for stroke
* Hepatic or renal insufficiency
* Uncontrolled diabetes
* Seizures
* Steroids use
* Uncontrolled hormonal deficiencies

Primary outcomes:
measure: Assess the insulin resistance
timeFrame: At the beginning of the study and after 90 days.
Secondary outcomes:
measure: Assess lipids profile and weight
timeFrame: At the beginning of the study and after 90 days.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: General Hospital of the University of São Paulo
Study officials:
affiliation: Unit of neuroendocrinology, discipline of endocrinology, General Hospital of the University of São Paulo
name: Felipe HG Duarte, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Amaro AC, Duarte FH, Jallad RS, Bronstein MD, Redline S, Lorenzi-Filho G. The use of nasal dilator strips as a placebo for trials evaluating continuous positive airway pressure. Clinics (Sao Paulo). 2012;67(5):469-74. doi: 10.6061/clinics/2012(05)11.
Clinical trial NCT05274321: Efficacy of the Nanodropper Device on Pupillary Dilation
Official title: Efficacy of the Nanodropper Device on Pupillary Dilation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dilation
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Nanodropper, Inc.
First posted: 2022-03-10
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Prescription eye drop bottles elute drops that exceed the capacity of the human eye by five times. This study describes performing in clinic dilation using a novel solution for combating medical waste with Nanodropper, an eye drop bottle adapter that creates smaller eye drops.


Eligibility criteria: Inclusion Criteria:

* Participants under the age of 18 years old

Exclusion Criteria:

* Participants 18 years and older
* Pupillary or anterior segment abnormality
* Participants with pre-existing health conditions that would prevent pupillary dilation.

Primary outcomes:
measure: Spherical Equivalent
timeFrame: Before dilation and 30 minutes after dilation
measure: Maximum Pupil Diameter
timeFrame: Before dilation and 30 minutes after dilation
measure: Constriction Percentage
timeFrame: Before and 30 minutes after dilation
Secondary outcomes:
measure: Change in Intraocular Pressure
timeFrame: Before and 30 minutes After Dilation
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Julius Oatts, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01318421: A Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis
Official title: An Open-Label, Long-Term, Follow-Up Study of Subcutaneous ELND002 in Patients With Relapsing Forms of Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Multiple Sclerosis
Keywords: Relapsing forms of secondary progressive multiple sclerosis (SPMS)or relapsing-remitting multiple sclerosis (RRMS)
Lead sponsor: Elan Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2011-03-18
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the long-term safety and tolerability of ELND002 in patients with multiple sclerosis (MS) after participation in study MS103.


Eligibility criteria: Inclusion Criteria:

* This study is open only to subjects who have completed the week 12 visit in study ELND002-MS103 while taking their assigned dose of study drug.

Exclusion Criteria:

* Subject has no new medical contraindications to continue participation in the study.

Primary outcomes:
measure: To determine the safety and tolerability of ELND002 including the identification of dose-limiting toxicity(ies) (DLT).
timeFrame: 1 year
Secondary outcomes:
measure: To evaluate the PK/PD/BM measurement of ELND002 in patients with MS.
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03824821: Assessing Associations Between IBS Symptoms, Nutrition and QoL in IBS Patients Using a Questionnaire
Official title: Assessing Associations Between IBS Symptoms, Nutrition and QoL in IBS Patients Using a Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irritable Bowel Syndrome
Keywords: Nutrition
Irritable Bowel Syndrome
Quality of Life
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: Netherlands: Ministry of Health, Welfare and Sports
name: Ingredia S.A.
name: Nexira
name: Naturex
name: Bioiberica
name: Wecare
name: Roquette Freres
name: Darling
name: Winclove Probiotics B.V.
First posted: 2019-01-31
Enrollment: 2076
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: There were no strict inclusion and exclusion criteria, since many IBS patients do not have an official diagnosis of IBS. therefore, the ROME IV diagnostic criteria were included in the questionnaire, to assess whether subjects fit within the IBS profile.

Brief summary: This study is a cross-sectional observational study design that aimed to include 2000 IBS patients. We used several validated questionnaires, to assess IBS characteristics (such as subtype, severity), psychological features (QoL, anxiety and depression) and assess nutritional triggers.

Subjects filled in the questionnaire online, and was spread across the Netherlands.


Eligibility criteria: Inclusion Criteria:

* IBS-like symptoms

Exclusion Criteria:

* younger than 18 years

Primary outcomes:
measure: IBS subtype
timeFrame: 1 day (once )
measure: IBS severity
timeFrame: 1 day (once )
measure: Nutrition questionnaire
timeFrame: 1 day (once )
measure: Birmingham symptom questionnaire
timeFrame: 1 day (once )
Secondary outcomes:
measure: Irritable bowel syndrome Quality of Life questionnaire
timeFrame: 1 day (once )
measure: Hospital Anxiety and Depression Score (HADS)
timeFrame: 1 day (once )
measure: treatment options currently used
timeFrame: 1 day (once )
measure: Rome IV criteria
timeFrame: 1 day (once )
Other outcomes:
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University & Research
Study officials:
References:
Clinical trial NCT01016821: Oxycodone for Labor Pain - Pharmacokinetics (PK), Safety and Efficacy
Official title: The Efficacy and Safety of Intravenous Oxycodone and Plasma Oxycodone Concentrations in Labour Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Keywords: Oxycodone
Labour pain
Pregnancy
Pregnant women
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
First posted: 2009-11-20
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Childbirth is one of the most painful events that a woman is likely to experience, and thus is a major concern for most parturient. Severe pain releases stress mediators and may thus compromise fetus well-being if placental perfusion is decreased. Epidural analgesia is the golden standard for the management of severe labor pain. However, it could not always be used both due the parturient related factors and the organizational reasons.However, the knowledge on safety and efficacy of oxycodone involving mother, fetus and newborn is limited.

Aim of the study is firstly, to evaluate the efficacy and safety of oxycodone in labor pain healthy parturients. Secondly, to measure parturient's blood oxycodone concentration during labour and fetal concentration from placental umbilical vein and artery right after birth.


Eligibility criteria: Inclusion Criteria:

* Labouring healthy women
* Early labour
* Age 18-45 years

Exclusion Criteria:

* Sleep apnea or other central deficit affecting breathing
* Pulmonary insufficiency
* Liver of kidney insufficiency
* Use of mono amine oxidase medication
* Thyroid, pituitary insufficiency
* Paralytic ileus
* Other contraindication specified by the investigator

Primary outcomes:
measure: The efficacy and safety of oxycodone in labor pain
timeFrame: 24 hours
Secondary outcomes:
measure: The parturient's blood oxycodone concentration during labour and fetal concentration from placental umbilical vein and artery right after birth
timeFrame: 24 hours
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University Hospital
Study officials:
affiliation: Kuopio University Hospital
name: Merja Kokki, PhD
role: PRINCIPAL_INVESTIGATOR
References: