louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05629806: Effect of Acarbose and Mixture of Pioglitazone and Metformin in Patients With Type 2 Diabetes
Official title: Effect of Acarbose and Fixed Mixture of Pioglitazone and Metformin in Patients With Type 2 Diabetes Receiving Anti-diabetic Monotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Type 2 Diabetes
Blood Glucose Fluctuation
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-11-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Monotherapy with DPP-IV inhibitors, SGLT-2 inhibitors or insulin secretagogues frequently failed to maintain blood glucose in patients with type 2 diabtes. It was critical to determine which was more suitable of acarbose versus metformin plus pioglitazone.


Eligibility criteria: Inclusion Criteria:

* Willing to participate in this present study;
* Patients with type 2 diabetes receiving stable monotherapy of DPP-IV inhibitors, SGLT-2 inhibitors or insulin secretagogues for more than 3 months;
* Screening glycated hemoglobin (HbA1c) between 7.0% and 10.0%;
* Regular diet and exercise;
* Body mass index (BMI) ≥ 18.5 kg/m2

Exclusion Criteria:

* Intolerance of metformin, pioglitazone and acarbose;
* Severe liver disease or elevated transaminases (2.5-fold the upper limit);
* Renal dysfunction or elevated creatinine (1.3-fold the upper limit);
* Systemic steroids therapy or other medication influencing cholesterol metabolism in the past 3 months;
* Infection or stress state in the past 4 weeks;
* Pregnancy or lactation;
* Patients otherwise adjudged by the investigator to be inappropriate for inclusion into the study.

Primary outcomes:
measure: Blood glucose fluctuation
timeFrame: week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital, Nanjing Medical Univesity
Study officials:
References:
Clinical trial NCT03556306: Intraoperative Findings and Complications in Bariatric Surgery
Official title: Unexpected Intraoperative Findings and Complications in Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bariatric Surgery
Complication of Surgical Procedure
Obesity, Morbid
Lead sponsor: Hospital General Tlahuac
Sponsor class: OTHER_GOV
First posted: 2018-06-14
Enrollment: 405
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with obesity submitted to bariatric surgery (LGBP, LSG, and revisional surgery) in a single institution between January 2013 and March 2016.

Brief summary: Retrospective study with patients submitted to bariatric surgery between 2013 and 2016 at a single Institution. The objective was to analyze the incidence and causes of unexpected intraoperative findings and complications, change in surgical plan, extra surgeries and procedure interruption. All operative information was collected prospectively and aimed to describe any of the previous situations. Secondarily, a morbidity analysis was performed, correlating intraoperative complications with postoperative complications and length of stay.


Eligibility criteria: Inclusion Criteria:

* Patient submitted to bariatric surgery
* All patients met the guidelines defined by the National Institutes of Health (NIH) consensus: BMI equal or greater to 40kg/m2 or BMI 35 - 40 kg/m2 with some comorbidity

Exclusion Criteria:

* Patients with incomplete surgery data sheet and those subject to another type of bariatric surgery

Primary outcomes:
measure: Intraoperative Complications
timeFrame: During surgical time
measure: Intraoperative unexpected findings, change in surgical technique, surgery interruption
timeFrame: During surgical time
Secondary outcomes:
measure: Postoperative complications
timeFrame: 0-30 days
measure: Length of Hospital Stay
timeFrame: 0-30 days
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: The Obesity Clinic at Hospital General Tlahuac
Study officials:
affiliation: The Obesity Clinic at Hospital General Tlahuac
name: CARLOS ZERRWECK, MD
role: STUDY_DIRECTOR
affiliation: The Obesity Cklinic at Hospital General Tlahuac
name: Paul Joo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05735106: NC/TMD Ratio As a Difficult Airway Predictor in Obese Patients
Official title: Neck Circumference to Thyromental Distance Ratio As a Reliable Indicator for Predicting Difficult Intubation in Obese Patients for Elective Surgery Under General Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Difficult / Failed Intubation
Keywords: difficult intubation
NC/TM distance ratio
intubation difficulty score
Lead sponsor: KRL Hospital, Islamabad
Sponsor class: OTHER
First posted: 2023-02-21
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obese patients (BMI ≥30Kg/m2) of all genders, between age of 18 to 65 years, belonging to ASA class I-III, Undergoing elective surgery under general anesthesia

Brief summary: To assess accuracy of NC/TM distance ratio in terms of sensitivity, specificity, negative predictive value (NPV) and positive predictive value (PPV) for predicting difficult intubation in obese patient with Intubation difficulty score (IDS) as gold standard.

Detailed description: At Preanaesthesia clinic patients , neck circumference to Thyromental distance ratios of obese patients with BMI \>30Kg/m2 will be calculated and patients will be divided into two groups on the basis of Nc/TMD ratio as anticipated easy intubation ( NC/TMD\<5) And anticipated difficult intubation ( NC/TMD ≥5).

Intra-operatively, patients Intubation difficulty scale score will calculated and the data obtained from IDS score will be compared with NC/TMD ratio as a predictor of difficult Intubation and diagnostic accuracy of NC/TMD as a reliable indicator of difficult intubation in obese patients will be calculated by statistical analysis.

Eligibility criteria: Inclusion Criteria:

1. ASA physical status I to III
2. Body Mass Index (BMI) of 30kg/m2 or more
3. age 18-65 years

Exclusion Criteria:

1. non consenting
2. ASA class greater than III,
3. patients undergoing general anesthesia without tracheal intubation or under regional anesthesia,
4. patients with upper airway pathology such as maxillofacial fractures, upper airway tumors or cervical spine fracture, obstetric patients, refusal of the patient, previous head and neck surgery or radiotherapy.

Primary outcomes:
measure: Predictability of difficult airway
timeFrame: During anaesthesia induction
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: KRL Hospital
state: ICT
Study officials:
affiliation: KrlH Islamabad
name: Mahnoor Shabbir
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02013206: A Study of Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer Naive to Chemotherapy
Official title: An Parallel Phase II Study of Tarceva (Erlotinib) in Patients With Advanced Non-small Cell Lung Cancer (Stage IIIB/IV) Not Pre-treated by Chemotherapy Including Dose Escalation to Toxicity in Current and Former Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-12-17
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of Tarceva in two groups of patients with non-small cell lung cancer who have not been pre-treated with chemotherapy. One group, consisting of patients who have never smoked, will receive Tarceva 150 mg/day, and the other group, consisting of current/former smokers, will receive Tarceva 150 mg/day increasing to a maximum of 300 mg/day. The anticipated time on study treatment is 1-2 years.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* histologically documented advanced non-small cell lung cancer (stage IIIB/IV);
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
* no previous chemotherapy.

Exclusion Criteria:

* previous therapy which acts on Epidermal Growth Factor Receptor (EGFR) axis;
* clinical evidence of brain metastasis;
* any unstable systemic disease;
* unable to take oral medication;
* any significant ophthalmological abnormality.

Primary outcomes:
measure: Non-Progression Rate (NPR) at 8 Weeks
timeFrame: Week 8
Secondary outcomes:
measure: Objective Response Rate
timeFrame: Up to 2 years
measure: Disease Control Rate
timeFrame: Up to 2 years
measure: Duration of Response
timeFrame: Up to 2 years
measure: Time to Progression
timeFrame: Up to 2 years
measure: Progression-Free Survival
timeFrame: Up to 2 years
measure: Overall Survival
timeFrame: Up to 2 years
measure: Safety: Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Marseille
country: France
city: Villejuif
country: France
city: Hamburg
country: Germany
city: Milano
country: Italy
city: Rozzano
country: Italy
city: Amsterdam
country: Netherlands
city: Maastricht
country: Netherlands
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Manchester
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT01163006: Soluble Dietary Fibres in the Prevention of Type 2 Diabetes Mellitus
Official title: Soluble Dietary Fibres as Dietetic Aid to Reduce the Risks of Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Obesity
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Tate and Lyle Ingredients France
First posted: 2010-07-15
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: Controlling the glycemic impact of foodstuffs (by reducing the glycemic load of the diet by using soluble dietary fibres) may reduce the glycemic or insulinemic response. This may in turn result in a reduced inhibition of postprandial fat oxidation rate and a lower plasma triacylglycerol concentration A higher postprandial fat oxidation may result in less lipid accumulation in non-adipose tissue thereby improving insulin sensitivity and the metabolic profile in the longer term.


Eligibility criteria: Inclusion Criteria:

* Overweight men and women

Exclusion Criteria:

* regular smokers, athletes, diabetes mellitus

Primary outcomes:
measure: fat oxidation
Secondary outcomes:
measure: 24h glucose pattern
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University
Study officials:
References:
Clinical trial NCT02525406: Models for Improving Operating Room Productivity: Delays, Cancellations and Pre-admission Testing
Official title: Models for Improving Operating Room Productivity: Delays, Cancellations and Pre-admission Testing
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Other Surgical Procedures
Lead sponsor: University of Toledo
Sponsor class: OTHER
First posted: 2015-08-17
Enrollment: 9240
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients scheduled for surgery at UTMC from Jan 01,2010 to August 31, 2020

Brief summary: The goal of the study is to identify factors that enhance productivity and increase value delivered by hospitals drawing on concepts used in industry for quality and productivity in production and operations management literature. The investigators intend to look at surgeon experience, patient characteristics and pre-admission testing on operating room productivity.


Eligibility criteria: Inclusion Criteria:

* All scheduled surgical patients' information gathered in Surgery database from January 2010 thru August 2020 will be included.

Exclusion Criteria:

* Any case type where less than 5 surgeries were performed by a surgeon would be excluded and if the surgeon in question had less than 3 months of data available.

Primary outcomes:
measure: Surgical Experience vs Average Completion times of surgical procedures
timeFrame: intraoperative
Secondary outcomes:
measure: Variability in Completion times of surgical procedures to predict scheduling difficulties.
timeFrame: intraoperative
measure: Preadmission Testing and how it relates to the surgical procedure: time to completion, delays in starting time and/or cancellation.
timeFrame: Day 1
measure: Patient Acuity vs Complexity of surgical procedure
timeFrame: Day 1
Other outcomes:
Locations:
city: Toledo
country: United States
facility: University of Toledo
state: Ohio
Study officials:
affiliation: University of Toledo
name: Andrew B. Casabianca, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00672906: Group Parent Training for Adolescent Eating Disorders
Official title: Group Parent Training for Adolescent Eating Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Anorexia Nervosa
Subthreshold Anorexia Nervosa
Keywords: anorexia nervosa
group parent training
caregiver burden
eating disorders
treatment
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2008-05-06
Enrollment: 124
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: While parents are considered essential for the effective treatment of adolescents with anorexia nervosa, the most effective manner to involve parents in treatment is unknown. Given reports of high caregiver burden among parents of this clinical group, finding treatments that minimize parent burden while improving the child's eating disorder symptoms is essential.

This investigation will examine the preliminary effectiveness of a parent skills group and adolescent skills group compared to family therapy for the treatment of adolescent anorexia nervosa. The target of this intervention is the improvement of eating disorder symptoms in the child and improving self-efficacy, emotion regulation, and perceived burden in the parent.

The effectiveness of this experimental treatment group (Group Parent Training for the parents/Adolescent Skills Training for the adolescent) will be compared to the Maudsley model of family therapy. The effectiveness of the group program will be examined by exploring changes within individuals over time as well as via comparisons across treatment conditions. Results from this investigation will be used to calculate treatment effect sizes in the design of a larger, fully powered, randomized clinical trial.


Eligibility criteria: Inclusion Criteria:

* age 11-18 years old
* living at home
* meet criteria for anorexia nervosa or subthreshold anorexia nervosa

Exclusion Criteria:

* no active psychosis
* no current suicidality
* medically safe for outpatient treatment

Primary outcomes:
measure: Body Mass Index
timeFrame: 12 months
Secondary outcomes:
measure: Eating disorder symptoms other than body weight.
timeFrame: 12 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References:
Clinical trial NCT02443506: A Study to Examine the Safety, Pharmacokinetics and Pharmacodynamics of Single Dose of AMG 623 in Subjects With Systemic Lupus Erythematosus
Official title: A Randomized Double-blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 623 Following Single Dose Administration in Subjects With Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Systemic Lupus Erythematosus
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2015-05-14
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to evaluate the safety of AMG 623 in subjects with systemic lupus erythematosus. The study consists of a 21 day screening period followed by administration of the investigational product and up to 70 day follow up period.


Eligibility criteria: Inclusion Criteria:

* Men and women, between the ages of 18 and 55
* Diagnosis of SLE
* Have had a disease duration of at least 1 year, as diagnosed by a physician

Exclusion Criteria:

* Have a disorder (including psychiatric), condition or clinically significant disease (other than a diagnosis of SLE) that would interfere with the study evaluation, completion and/or procedures per the investigator's discretion
* Have active vasculitis, active CNS lupus requiring therapy, active acute renal disease, uncontrolled hypertension, uncontrolled diabetes or active systemic infection
* Have had signs or symptoms of viral or bacterial infection within 30 days of enrollment
* Have received a daily dose of greater than 10 mg prednisone (or equivalent) in the prior 30 days

Primary outcomes:
measure: Incidence of treatment emergent adverse events
timeFrame: up to 70 days
measure: Incidence of abnormal clinically significant vital signs
timeFrame: up to 70 days
measure: Incidence of abnormal clinically significant chemistry, hematology and urinalysis test results
timeFrame: up to 70 days
measure: Incidence of abnormal clinically significant ECG results
timeFrame: up to 70 days
Secondary outcomes:
measure: Pharmacokinetics profile of AMG 623 including Tmax, AUClast and Cmax
timeFrame: up to 70 days
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
citation: Stohl W, Merrill JT, Looney RJ, Buyon J, Wallace DJ, Weisman MH, Ginzler EM, Cooke B, Holloway D, Kaliyaperumal A, Kuchimanchi KR, Cheah TC, Rasmussen E, Ferbas J, Belouski SS, Tsuji W, Zack DJ. Treatment of systemic lupus erythematosus patients with the BAFF antagonist "peptibody" blisibimod (AMG 623/A-623): results from randomized, double-blind phase 1a and phase 1b trials. Arthritis Res Ther. 2015 Aug 20;17(1):215. doi: 10.1186/s13075-015-0741-z.
Clinical trial NCT00688506: Combined Sono-electro-magnetic Therapy for Treatment of Refractory Chronic Pelvic Pain Syndrome
Official title: Combined Sono-electro-magnetic Therapy for Treatment of Refractory Chronic Pelvic Pain Syndrome: A Prospective, Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pelvic Pain Syndrome
Keywords: Chronic pelvic pain syndrome
Neuromodulation
Brain effects
Neuroimaging
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2008-06-03
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of chronic pelvic pain syndrome (CPPS) is challenging for patients and physicians once conventional therapies fail.

We hypothesize that combined sono-electro-magnetic therapy can improve refractory CPPS in men. In addition, we postulate that combined sono-electro-magnetic therapy as well as placebo therapy has a significant effect on brain activity detectable by functional MRI.


Eligibility criteria: Inclusion Criteria:

* CPSS III
* symptomatic \>3 months
* NIH-CPSI total score =/\>15
* NIH-CPSI pain =/\>8

Exclusion Criteria:

* post void residual \>100mL
* urinary tract infection
* urethral stricture
* prostate cancer
* age \<18 years
* claustrophobia
* pacemaker, neurostimulator, insulin / pain pump

Primary outcomes:
measure: National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI)
timeFrame: before treatment, after 6 and 12 weeks of treatment as well as 4 weeks after stop of treatment
Secondary outcomes:
measure: Brain activity assessed by functional MRI
timeFrame: before treatment, after 12 weeks of treatment
measure: Comparison of MRI of CPPS patients versus MRI of age-/sex-matched controls of the local neuro-radiology MRI database
timeFrame: before treatment
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Urology, University of Bern
Study officials:
affiliation: Department of Urology, University of Bern, 3010 Switzerland
name: Thomas M Kessler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kessler TM, Mordasini L, Weisstanner C, Juni P, da Costa BR, Wiest R, Thalmann GN. Sono-electro-magnetic therapy for treating chronic pelvic pain syndrome in men: a randomized, placebo-controlled, double-blind trial. PLoS One. 2014 Dec 29;9(12):e113368. doi: 10.1371/journal.pone.0113368. eCollection 2014.