louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06288854: Efficacy of Olanzapine on Weight Gain in Advanced Gynecologic Cancer with Paclitaxel and Carboplatin: a Double Blind, Placebo-controlled Randomized Trial
Official title: Efficacy of Olanzapine on Weight Gain in Women with Advanced Stage Gynecologic Cancer Receiving Paclitaxel and Carboplatin Combination Chemotherapy : a Double Blind, Placebo-controlled Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Weight Gain
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2024-03-01
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: olanzapine vs placebo
Primary purpose: PREVENTION

Brief summary: * Efficacy of olanzapine on weight gain in advanced stage gynecologic cancer
* Proprotion of pateints in advanced stage gynecologic cancer who recieving paclitaxel and carboplatin chemotherapy gain weight on olanzapine or placebo

Detailed description: -Proprotion of pateints in advanced stage gynecologic cancer who recieving paclitaxel and carboplatin chemotherapy gain weight on olanzapine or placebo

Eligibility criteria: Inclusion Criteria:

* Advanced stage gynecologic cancer receiving Paclitaxel and carboplatin chemotherapy
* ECOG 0-1
* Normal CBC,Liver, renal function
* Communication in Thai language or Thai caregiver
* Inform consent

Exclusion Criteria:

* Pregnancy
* Active infection
* Bowel obstruction or history of bowel surgery
* On dopamine receptor antagonists or psychiatric or anticonvulsant medication
* Olanzapine allery
* Abnormal function of liver and renal
* Diabetic melitus or morbid obesity
* patient can't selfcare

Primary outcomes:
measure: Efficacy of olanzapine on weight gain in advanzed stage gynecologic cancer recieving paclitexal and carboplatin chemotherapy
timeFrame: 12 weeks after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
References:
Clinical trial NCT04282954: Clinical Trial to Evaluate the Safety and Efficacy of JP-1366 in Patients With Erosive Gastroesophageal Reflux Disease
Official title: A Randomized, Double-blind, Active-controlled, Multi-center Phase II Clinical Trial to Evaluate the Safety and Efficacy of JP-1366 in Patients With Erosive Gastroesophageal Reflux Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: GERD
Lead sponsor: Onconic Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2020-02-25
Enrollment: 188
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical trial to evaluate the safety and efficacy of JP-1366 in patients with erosive gastroesophageal reflux disease


Eligibility criteria: Inclusion Criteria:

* Adults between 19 and 75 years old based on the date of written agreement
* Those who have been diagnosed with erosive gastroesophageal reflux disease(EGRD) of LA Grade A-D on the upper gastrointestinal endoscopy
* Those who experienced symptoms of heartburn or acid reflux within the last 7 days

Exclusion Criteria:

* Those who have undergone gastric acid suppression or gastric, esophageal surgery
* Those who with clinically significant liver, kidney, nervous system, respiratory, endocrine, hematologic, cardiovascular, urinary system disease
* Clinically significant abnormal laboratory values during screening

Primary outcomes:
measure: Accumulated mucosal defect cure rate*(%) at Week 8 following study drug administration (%)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital and 19 hospitals
Study officials:
References:
Clinical trial NCT00138554: Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes
Official title: Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2 diabetes
vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-08-30
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. This is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to pioglitazone in people with type 2 diabetes not at target blood glucose levels on pioglitazone or rosiglitazone alone. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Only patients successfully completing study CLAF237A2304 are eligible
* Written informed consent
* Ability to comply with all study requirements

Exclusion Criteria:

* Premature discontinuation from study CLAF237A2304
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Safety of vildagliptin in combination with pioglitazone during 52 weeks of treatment
measure: Change from baseline in HbA1c at 52 weeks
Secondary outcomes:
measure: Change in HbA1c between 24 weeks and 52 weeks
measure: Change from baseline in fasting plasma glucose at 52 weeks
measure: Change in fasting plasma glucose between 24 weeks and 52 weeks
measure: Change from baseline in HOMA B at 52 weeks
measure: Change from baseline in HOMA IR at 52 weeks
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Ligueros-Saylan M, Foley JE, Schweizer A, Couturier A, Kothny W. An assessment of adverse effects of vildagliptin versus comparators on the liver, the pancreas, the immune system, the skin and in patients with impaired renal function from a large pooled database of Phase II and III clinical trials. Diabetes Obes Metab. 2010 Jun;12(6):495-509. doi: 10.1111/j.1463-1326.2010.01214.x.
Clinical trial NCT02761954: Variation of Cerebral Blood Flow in Anterior Cerebral and Basilar Artery in Neonates and Infants in Genreal Anesthesia With Caudal Block
Official title: Variation of Cerebral Blood Flow in Anterior Cerebral and Basilar Artery in Neonates and Infants - a Prospective Study During Planed Surgery of the Infra Umbilical Region in Combined Anaesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pediatric Anesthesia
Keywords: regional anesthesia
caudal block
Lead sponsor: Bürgerhospital Frankfurt
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 50
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: infants and neonates undergoing a infraumbilical surgery in general anesthesia with caudal block

Brief summary: With this study we want to see how the blood flow in the anterior cerebral artery (ACA) and the basilar artery (BA) after the caudal block changes.


Eligibility criteria: Inclusion Criteria:

* opened big fontanella
* infraumbilical surgery

Exclusion Criteria:

* cardiac or cerebral disease
* prior operation on vertebra, heart or head/brain
* malforamtion of head or vertebra
* closed fontanella
* contraindication for caudal block (von-Willebrand-Syndrome, haemophilia,...)

Primary outcomes:
measure: depression of blood flow in ACA & basilar artery after caudal block
timeFrame: one hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06564454: Knowledge, Attitude and Practices Regarding Green Eco-Friendly Dentistry Among a Group of Dentists
Official title: Assessment of Knowledge, Attitude and Practices Regarding Green Eco-Friendly Dentistry Among a Group of Dentists: A Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knowledge, Attitudes, Practice
Keywords: Green Dentistry
Eco-friendly Dentistry
Knowledge
Attitude
Practice
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 302
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Graduated dentists.

Brief summary: Global warming, reduction in resources, increase in prices are all factors leading to more direction towards reuse, recycling, and reduction in use of materials. The World Dental Federation (FDI) considers sustainability to be an indispensable principle of Dentistry, which "must be practiced ethically, with high levels of quality and safety, in the pursuit of optimal oral health. Sustainability requires more attention from dental health professionals to reduce, recycle and reuse available resources.

Detailed description: The direction towards more reuse, recycling and reduction in the use of materials is a global direction. The Egyptian society needs to address the concepts, however, there is lack of knowledge on the knowledge, attitude, and practices of Egyptian dentists regarding green eco-friendly Dentistry.

Research question:

What is the knowledge, attitude, and practices of a group of dentists regarding green eco-friendly Dentistry?

Eligibility criteria: Inclusion Criteria:

* Graduated dentists.
* Dentists graduated from Egyptian universities.

Exclusion Criteria:

* Refusal of participation.

Primary outcomes:
measure: Knowledge, attitude, and practices regarding green eco-friendly Dentistry.
timeFrame: Immediately after the dentists complete the questionnaire
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
References:
Clinical trial NCT04705454: Loncastixumab Tesirine (ADCT-402) Expanded Access Program (EAP) for Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Relapsed or Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL)
Keywords: Expanded Access
Lymphoma
Large B-Cell
Relapsed
Refractory
Lead sponsor: ADC Therapeutics S.A.
Sponsor class: INDUSTRY
First posted: 2021-01-12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: The EAP is for patients with relapsed/refractory diffuse large b-cell lymphoma (R/R DLBCL) that cannot be treated by currently available drugs, cell therapy, or clinical trials. ADC Therapeutics will evaluate patients for approval into the program.


Eligibility criteria: Inclusion Criteria:

* Male or female patient aged 18 years or older
* Pathologic diagnosis of DLBCL
* Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL) that cannot be treated by currently available drugs, cell therapy, or clinical trials
* Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least six months after the last dose of loncastuximab tesirine. Men with female partners who are of childbearing potential must agree that they will use a highly effective method of contraception from the time of giving informed consent until at least six months after the patient receives his last dose of loncastuximab tesirine

Exclusion Criteria:

* Known history of hypersensitivity to or positive serum human Anti-Drug Antibodies to loncastuximab tesirine
* Total bilirubin \>1.5 x upper limit of normal (ULN)
* Active second primary malignancy other than non-melanoma skin cancers, nonmetastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that ADCT Head of Medical Affairs and/or designee, and treating physician agree and document should not be exclusionary
* Autologous Stem Cell Transplantation (SCT) within 30 days prior to start of loncastuximab tesirine
* Allogeneic SCT within 60 days prior to start of loncastuximab tesirine
* Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath)
* Lymphoma with active central nervous system involvement at the time of screening, including leptomeningeal disease
* Breastfeeding or pregnant
* Major surgery, radiotherapy, chemotherapy or other anti-neoplastic therapy within 14 days prior to starting loncastuximab tesirine, except shorter if approved by ADCT
* Use of any other experimental medication within 14 days prior to starting loncastuximab tesirine
* Any other significant medical illness, abnormality, or condition that would, in the treating physician's judgment, make the patient inappropriate to receive loncastuximab tesirine or put the patient at risk

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05476354: Clinical Efficacy and Safety Evaluation of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients
Official title: A Randomized, Double-blind, Multicenter, Placebo-control, Parallel Group Phase 3 Study to Evaluate the Efficacy and Safety of Irbesartan and Amlodipine Combined Therapy in Essential Hypertension Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Essential Hypertension
Lead sponsor: Handok Inc.
Sponsor class: INDUSTRY
First posted: 2022-07-27
Enrollment: 271
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate efficacy and safety of Irbesartan and Amlodipine combined therapy in patients with essential hypertension inadequately controlled on Irbesartan monotherapy


Eligibility criteria: Inclusion Criteria:

* Patients who are 19 years or older on screening
* Signed informed consent
* Patients with Essential Hypertension
* Other inclusion applied

Exclusion Criteria:

* Orthostatic hypotension
* Other exclusion applied

Primary outcomes:
measure: Change from baseline in mean sitting systolic blood pressure(mmHg)
timeFrame: Week8
Secondary outcomes:
measure: Change from baseline in mean sitting systolic blood pressure(mmHg)
timeFrame: Week 4
measure: 2.Change from baseline in mean sitting diastolic blood pressure(mmHg)
timeFrame: Week 4,8
measure: Responder rate
timeFrame: Week 4,8
measure: Target blood pressure reach rate
timeFrame: Week 4,8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT05036954: Observational Study on the Efficacy and Tolerance of EYEBRID Lenses
Official title: Observational Study on the Efficacy and Tolerance of EYEBRID Lenses
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Contact Lens Complication
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2021-09-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Contact lens wearers, cohort of 60 patients

Brief summary: Technical advances in lenses are continuous and materials are improved. We provide a prospective longitudinal observational study evaluating the efficacy and safety of new EyeBrid Excel hybrid lenses (LCS) in the treatment of severe ametropia and for patients with corneal irregularities.

This study should include 60 patients for a period of three months. The aim of this work is to assess the improvement in the best corrected visual acuity and the good tolerance of this lens.


Eligibility criteria: Inclusion Criteria:

* o Wear rigid lenses and complain about their lenses (discomfort, loss, poor vision) or

  * Wear rigid lenses and have objective intolerances (damage to surfaces related to rigid lenses) or
  * Are new wearers of lenses and presenting a strong ametropia (Strong myopia from -5.00 to -30.00d, strong hyperopia from + 4.50d to + 30.00d, strong astigmatism from 2.50d to 12.00d), with or without presbyopia (Addition of 0.75d to 3.50d)
* Any patient diagnosed with Keratoconus stages 1 to 3.
* Be affiliated to the social security system

Exclusion Criteria:

* Patient with contraindications to wearing contact lenses
* Pregnant or breastfeeding woman
* Any minor or over 80 years old
* Any infection, inflammation or abnormality of the anterior segments
* Progressive ocular disorder of the anterior segments for which the wearing of contact lenses would be discouraged;
* Use of systemic or ocular treatment products for which the wearing of contact lenses would be discouraged;
* History of any herpetic keratitis;
* History of any refractive surgery or any irregular cornea (except in cases where the contact lenses examined may be worn by a subject with an irregular cornea, suffering from keratoconus or having undergone refractive surgery);
* Slit lamp observations of greater than grade 1 gravity;
* Vascularization of the cornea with a penetration greater than 1 mm;
* Case of pathological dry eye;
* When a subject has participated in a clinical trial on contact lenses or contact lens care products within the past 30 days.

Primary outcomes:
measure: tolerance assesment
timeFrame: 3 month
Secondary outcomes:
measure: Improvement of visual acuity
timeFrame: 3 month
measure: Assessment and quantification of complications
timeFrame: 3 month
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
References:
Clinical trial NCT00303654: Loop Resectoscope in Treating Patients With Bladder Cancer or Benign Prostatic Hyperplasia Who Are Undergoing Transurethral Resection
Official title: Quality Assessment of the Roei Loop Resectoscope for Transurethral Resection of Bladder Neoplasm and BPH
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: recurrent bladder cancer
stage I bladder cancer
stage II bladder cancer
stage III bladder cancer
stage IV bladder cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2006-03-17
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: RATIONALE: Transurethral resection is a less invasive type of surgery for bladder cancer or benign prostatic hyperplasia. Transurethral resection using a loop resectoscope may have fewer side effects and improve recovery.

PURPOSE: This clinical trial is studying how well the loop resectoscope works in treating patients with bladder cancer or benign prostatic hyperplasia who are undergoing transurethral resection.

Detailed description: OBJECTIVES:

* Determine the efficacy, in terms of mechanical capabilities, of the Roei loop resectoscope in patients with bladder cancer or benign prostatic hyperplasia undergoing transurethral resection of bladder tumor or benign prostatic adenoma.
* Determine the quality of specimens submitted for histological analysis from patients undergoing this procedure.

OUTLINE: This is an open-label, pilot study.

Patients undergo transurethral resection using the Roei loop resectoscope. Surgeon satisfaction with the Roei loop resectoscope is measured by a self-assessment questionnaire. The quality of specimens submitted for histological study are also assessed.

PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of bladder cancer or benign prostatic hyperplasia

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Surgeon satisfaction with usage of Roei loop resectoscope measured by a questionnaire after the surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center at UCLA
state: California
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Allan Pantuck, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02923154: Efficacy and Safety of MT-3995 in Patients With Non-Alcoholic Steatohepatitis(NASH)
Official title: An Exploratory Study of MT-3995 in Patients With Non-Alcoholic Steatohepatitis(NASH) (Placebo-Controlled Double-Blind Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: NASH
Keywords: NASH
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2016-10-04
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy, safety, tolerability and pharmacokinetics of multiple oral administration of MT-3995 in patients with NASH.


Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed with NASH before randomization
* Subjects who conducts diet or exercise therapy at the beginning of run in period.
* Subjects who has given full and adequate information of the protocol and with written informed consent

Exclusion Criteria:

* Subjects with hepatic failure or previously diagnosed with hepatic cirrhosis
* Subjects with alcohol dependence or previously diagnosed with alcohol dependence
* Subjects with other chronic liver disease (e.g., primary sclerosing cholangitis, alcoholic liver damage, hemochromatosis, Wilson's disease)
* Presence, history, or family history of long QT syndrome or Torsades de Pointes
* Subjects with heart failure (New York Heart Association Class III-IV)

Primary outcomes:
measure: Percent change from baseline in ALT
timeFrame: 24 weeks
Secondary outcomes:
measure: Change from baseline in ALT
timeFrame: 24 weeks
measure: Adverse events
timeFrame: From baseline to 72 weeks
Other outcomes:
Locations:
city: Kanagawa
country: Japan
facility: Investigational site
city: Osaka
country: Japan
facility: Investigational site
Study officials:
affiliation: Mitsubishi Tanabe Pharma Corporation
name: General Manager
role: STUDY_DIRECTOR
References: