louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00138541: Extension to a Study to Assess the Efficacy and Safety of Three Doses of Vildagliptin in Patients With Type 2 Diabetes
Official title: Extension to a Study to Assess the Efficacy and Safety of Three Doses of Vildagliptin 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: 440
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: This is a 28-week extension to a study of the safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar. The purpose of the extension study is to gather long-term safety and efficacy data for vildagliptin in people with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Only patients successfully completing study CLAF237A2301 are eligible
* Written informed consent
* Ability to comply with all study requirements

Exclusion Criteria:

* Premature discontinuation from study CLAF237A2301
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Safety of vildagliptin 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 NCT05775341: INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Surgery
Official title: Analysis of INtestinal Dysbiosis and TRanslocation of Bacteria in Patients Undergoing Abdominal Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgical Site Infection
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing elective abdominal surgery

Brief summary: The goal of this observational study is to contribute to a better understanding of the perioperative kinetics of intestinal microbial composition and association with surgical site infections.

The main question this study aims to determine if:

* Patients undergoing surgery develop transient intestinal dysbiosis
* Such transient dysbiosis is associated with translocation to the systemic circulation and surgical site infection

Patients undergoing elective abdominal surgery will be included prospectively. Informed consent will be obtained. From patients the following information and samples will be collected:

* Perioperative: Baseline health data, nutrition data, measurement body composition, glucose monitoring
* Intraoperatively:

  * Mucosal swabs
  * Blood from central venous catheter and portal vein
  * Mesenteric lymph node
  * Intestinal specimen
  * Bile
  * Subcutaneous biopsy
* Postoperatively:

  * If a surgical site infection occurs samples from infected site


Eligibility criteria: Inclusion criteria:

* Patients undergoing laparoscopic colorectal resection with anastomosis or patients undergoing duodeno-pancreatectomy.
* Elective surgery
* Informed consent
* Age \> 18 years

Exclusion criteria:

* Emergency surgery
* Other surgery 30 days prior to colorectal surgery
* BMI \<18 or \>50kg/m2
* Planed simultaneous second procedure with involvement of the intestinal tract
* Cholestasis with cholangitis, hepatic disease (defined as cirrhosis Child B or C) or renal disease (acute or chronic renal failure defined as eGFR≤ 30ml/min)
* Severe active enteritis or colitis, malabsorption, enteric infections
* Pancreatitis

Primary outcomes:
measure: Changes of the intestinal microbiome between start and end of surgery
timeFrame: Day 0 (Day of Surgery)
Secondary outcomes:
measure: Bacterial taxonomy in the intestine
timeFrame: Day 0 (Day of Surgery)
measure: Bacterial taxonomy MLN
timeFrame: Day 0 (Day of Surgery)
measure: Bacterial taxonomy mucosal swabs
timeFrame: Day 0 (Day of Surgery)
measure: Bacterial taxonomy in the blood
timeFrame: Day 0 (Day of Surgery)
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Beldi Guido
Study officials:
affiliation: Department of Visceral Surgery and Medicine, Bern University Hospital
name: Guido Beldi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00925041: Clinical Evaluation of the Vedera KXS for the Treatment of Spherical Myopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2009-06-19
Enrollment: 40
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: The objective of this clinical investigation is to evaluate the safety and efficacy of the Vedera KXS in sighted eyes for the correction of spherical myopia.


Eligibility criteria: Inclusion Criteria:

* Must be undergoing surgery for the correction of myopia
* Intended treatment from -0.5 to -6.0 D of spherical myopia
* Must have 0.50 D or less astigmatic component.
* Must have bilateral physiologic myopia
* BSCVA of 20/25 or better in each eye
* Must have had a stable refraction (0.5 D or less change in spheroequivalent) for at least one year, objectively documented (by previous clinical records, eyeglass prescriptions, etc. over one year old)
* Patients who are contact lens wearers must have hard or gas permeable lenses discontinued for two weeks and soft lenses discontinued for three days prior to the preoperative evaluation
* Must be at least 18 years of age
* Corneal topography must be normal, as judged by the investigator
* Must have a minimal corneal thickness of 475 microns
* Must sign a written Informed Consent form acknowledging their awareness of their participation in this study, the alternative treatments available, the risks involved, and the investigative nature of the procedure, and other issues which conform to the standard of care for Informed Consent practices
* Must be willing and capable of returning for scheduled follow-up examinations for 24 months after treatment

Exclusion Criteria:

* Patients who are unable or unwilling to sign the informed consent form.
* Anterior segment pathology
* Residual, recurrent or active ocular disease
* Patients who have undergone previous intraocular or corneal surgery involving the stroma in the eye to be operated.
* History of herpes keratitis
* Patients with diagnosed autoimmune disease, systemic connective tissue diseases or atopic syndrome, diabetes mellitus, or taking systemic medications (i.e., corticosteroids or antimetabolites) likely to affect wound healing.
* Irregular central keratometry/topography readings with irregular topography patterns or keratometry mires, including signs of keratoconus.
* Patients with known sensitivity to study medications.
* Intraocular pressure of \> 23 mm Hg by Goldmann applanation tonometry, a history of glaucoma, or glaucoma suspect.
* Women who are pregnant or nursing or who plan to become pregnant over the course of their participation in this investigation.
* Participation in other ophthalmic clinical trials during this clinical investigation.

Primary outcomes:
measure: UCVA 20/40 or better
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Beyoglu Eye Research and Education Hospital
Study officials:
References:
Clinical trial NCT01003041: The Influence of Hearing Discrete Phonemes in Mother's Voice in the Infant's Natural Environment and With Natural Melody on Developing Phonetic Categories Between 4-10 Months Old
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: healthy normal infants
Lead sponsor: Maaynei Hayesha Medical Center
Sponsor class: OTHER
First posted: 2009-10-28
Enrollment: 50
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: normal newborn infants

Brief summary: The purpose of this study is to record voice samples of infant's mothers, process in samples to a phonetic musical piece, play the phonetic musical piece to 4-10 month old infants, and then test the infants in a conditioned head turning test in lab, and to analyze the results.


Eligibility criteria: Inclusion Criteria:

* normal newborn infants
* males and females
* age 4 months to 10 months old

Exclusion Criteria:

* chronic illness
* hearing loss
* history of otitis media
* serious otitis media

Primary outcomes:
measure: Response by head-turning test to familiar and unfamiliar phonetic categories
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05359341: Which is Better to Start With DPP-4 Inhibitors or SGLT-2 Inhibitors in Egyptian Diabetic Patients?
Official title: Comparative Study of DPP-4 Inhibitors and SGLT-2 Inhibitors in Egyptian Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabete Type 2
Lead sponsor: Sadat City University
Sponsor class: OTHER
Collaborators: name: Beni-Suef University
First posted: 2022-05-03
Enrollment: 175
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Our trial goal is to determine the efficacy and safety of sitagliptin in comparison with empagliflozin in type 2 diabetic Egyptian patients.


Eligibility criteria: Inclusion Criteria:

* Type 2 male/female diabetic patients
* Age 20-70 years
* A1C less than 10.5%

Exclusion Criteria:

* Type 1 diabetes; HbA1c \> 10.5%
* Pregnancy
* Chronic liver disease
* Elevated (more than twofold the upper limit of normal) ALT, AST and CPK.
* High bilirubin
* Albumin \< 3.5 g/dl
* INR \>1-2 Diabetic ketoacidosis
* Urinary tract infection (UTI)
* Pancreatitis \< 6 months prior to enrolment
* Renal impairment (creatinine clearance ≤50 ml/min)
* Treatment with anti-obesity drugs or glucagon-like peptide-1 receptor agonists (GLP-1RAs) 3 months prior to enrolment
* Non-compliance with follow-up visits.

Primary outcomes:
measure: Proportion of cured patients in the sitagliptin group versus the proportion of cured patients in the empagliflozin group
timeFrame: After completion of the study (One year anticipated)
Secondary outcomes:
measure: The decrease in the body weight in patients in sitagliptin group versus empagliflozin group
timeFrame: After completion of the study (One year anticipated)
measure: The decrease in blood pressure in patients in sitagliptin group versus empagliflozin group
timeFrame: After completion of the study (One year anticipated)
measure: The change in lipid profile in patients in sitagliptin group versus empagliflozin group
timeFrame: After completion of the study (One year anticipated)
Other outcomes:
measure: Percentage of adverse effects appeared in patients in sitagliptin group versus percentage of adverse effects appear in patients in the empagliflozin group.
timeFrame: After completion of the study (One year anticipated)
Locations:
city: El Sadat
country: Egypt
facility: University of Sadat City
Study officials:
References:
Clinical trial NCT04007341: Effect of Dexmedetomidine on the Inflammatory Response After One-lung Ventilation
Official title: Effect of Dexmedetomidine on the Inflammatory Response in Patients Undergoing Lung Resection Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 40
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 postoperative inflammatory response is significant in lung resection surgery because of major operation and one-lung ventilation. Dexmedetomidine has been shown to reduce pro-inflammatory cytokine levels and improve clinical outcomes. The aim of this study was to determine the effects of dexmedetomidine on inflammatory responses after lung resection surgery.


Eligibility criteria: Inclusion Criteria:

* elective video-assisted thoracoscopic surgery (VATS) lobectomy
* 20 \< age \< 75
* American Society of Anesthesiologists (ASA) classification I\~II

Exclusion Criteria:

* preoperative inflammation (CRP\>10ng/#, WBC\>10,000/mm3, body temperature \>38#)
* steroid administration within 1 month
* hematologic / autoimmune disease
* congestive heart failure (NYHA class III\~IV) or significant arrhythmia
* severe obstructive / restrictive pulmonary disease
* previous history of thoracic surgery

Primary outcomes:
measure: Interleukin (IL)-6
timeFrame: 24 hours after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul St.Mary's Hospital
Study officials:
References:
Clinical trial NCT04620941: Use of Reticulocyte Ratio and Neutrophil / Lymphocyte Ratio in the Diagnosis of Ventilator-associated Pneumonia
Official title: Use of Reticulocyte Ratio and Neutrophil / Lymphocyte Ratio in the Diagnosis of Ventilator-associated Pneumonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventilator-associated Pneumonia (VAP)
Keywords: Ventilator-associated pneumonia
reticulocyte/hemoglobin ratio
neutrophil/lymphocyte ratio
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2020-11-09
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who need mechanical ventilation for longer than 48 hours for a noninfectious reason in the intensive care unit

Brief summary: In this study, the utility of changes in the ratio of Ret-He and NLR as an early inflammation marker for VAP will be evaluated.

Detailed description: Ventilator-associated pneumonia (VAP) is one of the most common nosocomial infections in the intensive care unit, affecting one third of patients requiring mechanical ventilation for a noninfectious reason. In the case of inflammation, iron retention increases in the reticuloendothelial system cells; hemoglobin (Hb) synthesis is reduced. It has been reported that the ratio of reticulocyte / hemoglobin (Ret-He) decreases in the early period in community-acquired pneumonia patients and may be a guide as a marker of inflammation. In addition, the neutrophil / lymphocyte ratio (NLR) is a parameter studied in the hemogram panel. It provides a clue to both the presence of infection and the focus of the infection.

In this study, the utility of changes in the ratio of Ret-He and NLR as an early inflammation marker for VAP will be evaluated.

Eligibility criteria: Inclusion Criteria:

-Patients who need mechanical ventilation for longer than 48 hours for a noninfectious reason in the intensive care unit

Exclusion Criteria:

* Pulmonary or extrapulmonary infection before mechanical ventilation,
* severe immunosuppression,
* bleeding in the gastrointestinal system,
* using corticosteroids,
* neoplastic disease history

Primary outcomes:
measure: Early inflammation markers for VAP
timeFrame: 7 days
Secondary outcomes:
measure: morbidity and mortality
timeFrame: 7 days
Other outcomes:
Locations:
city: Muğla
country: Turkey
facility: Mugla Sitki Kocman Universty
state: Kötekli
Study officials:
affiliation: Mugla Sitki Kocman Universty Department of Infection Disease
name: turhan togan
role: STUDY_CHAIR
affiliation: Mugla Sitki Kocma University Department of Intensive Care
name: Canan Gursoy
role: STUDY_CHAIR
affiliation: Mugla Sitki Kocman Universty Department of Anesthesia
name: Semra Demirbilek
role: STUDY_CHAIR
References:
Clinical trial NCT06477341: The Effect of Active Nutritional Support On Quality Of Life In Patients With Head And Neck Cancer Receiving Radiotherapy
Official title: The Effect of Active Nutritional Support On The Incidence Of Mucositis And Quality Of Life In Patients With Head And Neck Cancer Receiving Radiotherapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Neoplasms
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-06-27
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: note effect of appropriate nutrition on head and neck cancer patients receiving radiotherapy

Detailed description: Head and neck cancer (HNC) is the sixth most common cancer worldwide with more than half a million new cases diagnosed each year . Because of the limitations imposed by the complicated anatomical structure of the head and neck to the operation, radiotherapy (RT) has become the main treatment method for HNC. However, damage to the normal tissue surrounding the tumor is inevitable. The most common manifestations of injury caused by RT are mucositis with the dry mouth, loss of taste, and dysphagia. The severe dysphagia leads to a definitive total impossibility of eating through the mouth in 20-30% of patients. Radiation-induced oral mucositis (RIOM) is a common side effect after radiotherapy (RT) in head and neck cancer (HNC) patients. RIOM patients with severe pain have difficulty in eating, which increases the incidence of malnutrition and affects patients' quality of life and the process of RT.

Eligibility criteria: Inclusion Criteria:

* head and neck cancer patients with age \>18
* Newly diagnosed head and neck cancer patients
* histological proven HNC cancer
* head and neck cancer patients treated with radiotherapy or chemo radiotherapy

Exclusion Criteria:

* Advanced and Metastatic head and neck cancer patients
* head and neck cancer patients treated with chemotherapy only

Primary outcomes:
measure: nutritional status of patients
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Reham mohamed
Study officials:
affiliation: Assiut University
name: Asmaa Abdehtawab, lecturer
role: STUDY_CHAIR
References:
Clinical trial NCT04511741: Epidemiological Survey of Children With Prolonged Mechanical Ventilation.
Official title: Epidemiological Survey of Children With Prolonged Mechanical Ventilation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prolonged Mechanical Ventilation
Keywords: prolonged mechanical ventilation
Children
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2020-08-13
Enrollment: 346
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients who need prolonged mechanical ventilation aged from one month to 18 years old.

Brief summary: Mechanical ventilation is an effective treatment for respiratory failure, no more than ten percent of patients with respiratory failure need long-term mechanical ventilation.

Detailed description: Mechanical ventilation is an effective treatment for respiratory failure, no more than ten percent of patients with respiratory failure need long-term mechanical ventilation. There is a lack of data on children with long-term mechanical ventilation in China.The investigators conducted this study to investigate the clinical characteristics of children with long-term mechanical ventilation in China. The investigators conducted a multicenter clinical epidemiological survey.The study included PICU wards in major children's hospitals in China and investigated the causes of prolonged mechanical ventilation, the outcome of long-term mechanical ventilation.PMV definition: continuous invasive or noninvasive ventilation time ≥ 21 days, daily ≥ 6 hours.

Eligibility criteria: Inclusion Criteria: patients who need prolonged mechanical ventilation aged from one month to 18 years old.

-

Exclusion Criteria: Other clinical conditions not suitable to participate considered by investigator.

-

Primary outcomes:
measure: the cause of prolonged mechanical ventilation
timeFrame: At enrollment
Secondary outcomes:
measure: mortality rate
timeFrame: During the procedure (about 2 years)
measure: the length of prolonged mechanical ventilaton
timeFrame: During the procedure (about 2 years)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children' hospital of Fudan university
state: Shanghai
Study officials:
affiliation: children' hospital of Fudan university
name: Chen Weiming
role: STUDY_DIRECTOR
References:
citation: Racca F, Berta G, Sequi M, Bignamini E, Capello E, Cutrera R, Ottonello G, Ranieri VM, Salvo I, Testa R, Wolfler A, Bonati M; LTV Pediatric Italian Network. Long-term home ventilation of children in Italy: a national survey. Pediatr Pulmonol. 2011 Jun;46(6):566-72. doi: 10.1002/ppul.21401. Epub 2010 Dec 30.