louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02479022: A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Insulin 320 in Healthy Subjects
Official title: A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Insulin 320 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2015-06-23
Enrollment: 84
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of the trial is to investigate the safety, tolerability, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of insulin 320 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Male, aged 18-55 years (both inclusive) at the time of signing informed consent
* Body mass index 18.5-28.0 kg/m\^2 (both inclusive)
* Subject who is considered to be healthy based on the medical history, physical examination, and the results of vital signs, electrocardiograms and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

* Known or suspected hypersensitivity to trial products or related products
* Previous participation in this trial. Participation is defined as signed informed consent
* Any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol
* Presence of clinically significant acute and chronic gastrointestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) as judged by the investigator

Primary outcomes:
measure: Number of treatment-emergent adverse events
timeFrame: From the time of trial product administration and until 12 days after trial product administration
Secondary outcomes:
measure: Area under the serum insulin concentration-time curve
timeFrame: From 0 to 288 hours after a single dose (SD)
measure: Area under the glucose infusion rate-time curve
timeFrame: From 0 to 24 hours after a single dose
Other outcomes:
Locations:
city: Neuss
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06395922: Blockbuster LMA Versus Baska Mask in Laparoscopic Cholecystectomy
Official title: Blockbuster LMA Versus Baska Mask in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blockbuster LMA
Baska Mask
Laparoscopic Cholecystectomy
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-05-02
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aimed to compare the performance and safety profiles of two supraglottic airway devices (SADs), the Blockbuster laryngeal mask airway (LMA) and the Baska Mask (BM), in patients underwent laparoscopic cholecystectomy (LC).

Detailed description: Laparoscopic surgery has become increasingly prevalent across numerous surgical disciplines due to the well-established benefits it offers over traditional open procedures. Laparoscopic cholecystectomy (LC), the surgical removal of the gallbladder, stands out as one of the most frequently performed laparoscopic operations worldwide.

Supraglottic airway devices (SADs) play a crucial role in airway management algorithms, serving as viable alternatives in both anticipated and unanticipated difficult airway situations.

The laryngeal mask airway (LMA) can be utilized to establish a routine airway during general anesthesia or, less frequently, as a conduit for tracheal intubation. Newer, improved LMA designs incorporate cuffs that provide higher sealing pressures than classic LMAs, while also allowing for the venting of gastric contents through a dedicated drain tube.

The Baska Mask (BM), a second-generation SAD, features a non-inflatable cuff that is continuous with the airway channel, thereby inflating with positive pressure ventilation to improve cuff seal.

Eligibility criteria: Inclusion Criteria:

* Aged 18-60 years
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status I-II.
* Scheduled for elective LC under general anesthesia.

Exclusion Criteria:

* Anticipated difficult airway.
* Renal dysfunction.
* Hiatus hernia.
* Obesity.
* Pregnancy.
* Patients taking rate-controlling medications, steroids, opioids, or regular antacids.

Primary outcomes:
measure: Oropharyngeal leak pressure
timeFrame: 30 min after insertion
Secondary outcomes:
measure: Device insertion time
timeFrame: 5 min after insertion
measure: The incidence of successful gastric tube placement
timeFrame: 10 min after insertion
measure: Complications
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El-Gharbia
Study officials:
References:
Clinical trial NCT06345222: Examining the Effect of Prolotherapy on Quality of Life and Painkiller Use in Patients With Knee Pain
Official title: Examining the Effect of Prolotherapy on Quality of Life and Painkiller Use in Patients With Knee Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: The Aim of This Research is to Investigate the Effect of Prolotherapy on Quality of Life and Painkiller Use in Patients With Chronic Knee Pain
Lead sponsor: Bursa Yüksek İhtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-04-03
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Case control study
Primary purpose: TREATMENT

Brief summary: 92 patients with a diagnosis of primary knee pain of unknown cause followed at the family medicine outpatient clinic and who met our exclusion criteria were invited to the study. When creating patient list, the examination of patients, interviews with patients, as well as their medical records and examinations were used. Patients were divided into two groups: prolotherapy (n=46) and control group (n=46) by simple randomization method. However, when the study started, 32 people in the prolotherapy group and 33 people in the control group of these patients participated in the study. Prior to the research, detailed information was provided about the research in the experimental and control groups and signed consent was obtained from all participants that they volunteered to participate in the research. 5% dectrose was applied to the prolotherapy group by injection method to the pain area. In the control group, existing medical treatments were continued and no injection procedure was performed. Before the research, all participants were evaluated with Case Report Form, Visual Analog Scale (VAS) and Quality of Life Scale Short Form (SF-36). The cases in the experimental and control groups were re-evaluated with the VAS and SF-36 scales at the first month.


Eligibility criteria: Inclusion Criteria:

* patients who suffer from primary knee osteoarthritis

Exclusion Criteria:

* Inflammatory knee pain
* Cellulitis
* Septic arthritis
* Local abscess
* Bleeding disorders
* Patient on anticoagulant medication
* Patients allergic to dextrose
* Diabetes Mellitus
* breathing problems
* Electrolyte imbalance
* Kidney or liver disease

Primary outcomes:
measure: change in knee pain with prolotherapy application
timeFrame: 1 month
measure: change in quality of life
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Yuksek Ihtisas Training and Research Hospital
state: Türkiye
Study officials:
affiliation: Bursa Yuksek Ihtisas Training and Research Hospital
name: Hakan Demirci, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT02954822: Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5mg and Glimepiride 4mg
Official title: A Randomized, Open-label, Multiple Dosing, Cross-over Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5mg and Glimepiride 4mg After Oral Administration in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type2 Diabetes
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-11-03
Enrollment: 36
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A randomized, open-label, multiple dosing, three treatment, three period, two sequence clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and glimepiride 4 mg after oral administration in healthy male subjects

Detailed description: A randomized, open-label, multiple-dose, three-treatment, three-period, two-sequence, crossover study

Eligibility criteria: Inclusion Criteria:

* Healthy Male Volunteers (Age: 19\~45years)
* 55\<Body Weight\<90, 18\<BMI\<27
* FPG: 70-125 mg/dL

Exclusion Criteria:

* galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* Clinically significant Medical History
* Allergy or Drug Hypersensitivity
* AST(SGOT), ALT(SGPT) \> Upper Normal Range\*1.5, eGFR\<80 mL/min
* Drink during clinical trial period
* Smoking during clinical trial period
* Grapefruit/Caffeine intake during clinical trial period
* No Contraception

Primary outcomes:
measure: AUCτ,ss for Evogliptin and Glimepiride
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Trials Center, Seoul National University Hospital
Study officials:
affiliation: Clinical Trial Center, Seoul National University Hospital
name: Kyung-Sang Yu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03079622: Manual Versus Electric Vacuum Aspiration for Pregnancy Termination Between 10-14 Weeks
Official title: Manual Versus Electric Vacuum Aspiration for Pregnancy Termination Between 10-14 Weeks: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abortion in First Trimester
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2017-03-14
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study titled, Manual Versus Electric Vacuum Aspiration for Pregnancy Termination Between 10-14 weeks: A Randomized Trial, is a randomized trial to compare procedure times for manual and electric vacuum aspiration for surgical abortion between 10 0/7 and 13 6/7 weeks gestation. Women presenting for surgical abortion between 10 0/7 and 13 6/7 weeks gestation will be randomized to either undergo manual vacuum aspiration (MVA) or electric vacuum aspiration (EVA). The investigators hypothesize that operative times will be increased when using manual vacuum aspiration, as compared to electric vacuum aspiration, for surgical abortion performed in the late first trimester (10 0/7 and-13 6/7 weeks).


Eligibility criteria: Inclusion Criteria:

* Between 10 0/7 and 13 6/7 weeks of gestation
* Documented intra-uterine pregnancy
* Presenting for surgical induced abortion at RHS
* English-speaking
* Age 18 or older

Exclusion Criteria:

* Spontaneous abortion
* Failed medical abortion
* Multiple gestation
* Uterine anomalies
* Lower uterine segment or cervical myomas
* History of 3 or more prior cesarean deliveries
* BMI \> 40
* Having the abortion procedure performed by a provider who does not perform MVA and EVA between 10 0/7 and 13 6/7 weeks

Primary outcomes:
measure: Operative time
timeFrame: Perioperative
Secondary outcomes:
measure: Conversion from electric to manual vacuum aspiration (or vice versa) during the procedure
timeFrame: Perioperative
measure: Provider acceptability
timeFrame: Perioperative
measure: Patient acceptability
timeFrame: Perioperative and 2 weeks postoperatively
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Jaclyn M Grentzer, MD, MSCI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00038922: Study Evaluating rhIL-11 in Left-Sided Ulcerative Colitis
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalating, Safety and Exploratory Pharmacogenomic Study of Orally Administered Recombinant Human Interleukin Eleven (rhIL-11) in Patients With Mild to Moderate Left-Sided Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Ulcerative Colitis
Inflammatory Bowel Disease
Keywords: Left-Sided
Ulcerative
Colitis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2002-06-07
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To explore the safety of orally delivered rhIL-11 in patients with mild to moderate left-sided ulcerative colitis.

To explore the effects of orally administered rhIL-11 on pharmacogenomics in blood samples and in colonic biopsy tissue samples.


Eligibility criteria: Inclusion Criteria:

* Documented, signed informed consent to participate in this study
* Age greater than or equal to 18 years
* Documented diagnosis of ulcerative colitis by standard clinical criteria, including endoscopy (either flexible sigmoidoscopy or colonoscopy, sufficient to define the proximal limit of disease) with biopsy

Exclusion Criteria:

* Crohn's disease
* Ulcerative proctitis
* Ulcerative colitis extending beyond the splenic flexure

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00568022: A Phase I Study of Ixabepilone in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer
Official title: A Phase I Study of Ixabepilone in Combination With Capecitabine in Japanese Patients With Metastatic Breast Cancer Previously Treated With an Anthracycline and a Taxane
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: R-Pharm
Sponsor class: INDUSTRY
First posted: 2007-12-05
Enrollment: 9
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended Phase II dose of ixabepilone in combination with capecitabine in Japanese participants with metastatic breast cancer.


Eligibility criteria: Inclusion Criteria:

* Women ≥ 20 years
* Histologically or cytologically confirmed diagnosis of adenocarcinoma originating in the breast

Exclusion Criteria:

* Number of prior chemotherapy lines of treatment in the metastatic setting ≥3

Primary outcomes:
measure: Participants Experiencing Dose Limiting Toxicity (DLT)
timeFrame: From initiation of drug through last day of Cycle 2 (Day 42)
measure: Participants Achieving the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
timeFrame: At the end of Cycle 2 (Day 42)
Secondary outcomes:
measure: Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline to Day 42, continuously
measure: Participant Tumor Response at Study Endpoint
timeFrame: At baseline and after every 42 days (every 2 21-day cycles) after baseline
measure: Mean Ixabepilone Maximum Plasma Concentration (Cmax) in One Dosing Interval
timeFrame: During Cycle 1 at specified timepoints (Day 1 to Day 8).
measure: Mean Ixabepilone Area Under the Concentration Curve (AUC INF) in One Dosing Interval
timeFrame: During Cycle 1 at specified timepoints (Day 1 to Day 8).
measure: Mean Ixabepilone Terminal Elimination Half Life (T 1/2) in One Dosing Interval
timeFrame: During Cycle 1 at specified timepoints (Day 1 to Day 8).
measure: Mean Ixabepilone Volume of Distribution at Steady State (Vss) in One Dosing Interval
timeFrame: During Cycle 1 at specified timepoints (Day 1 to Day 8).
measure: Mean Ixabepilone Total Body Clearance (CLT) in One Dosing Interval
timeFrame: During Cycle 1 at specified timepoints (Day 1 to Day 8).
Other outcomes:
Locations:
city: Matsuyama-Shi
country: Japan
facility: Local Institution
state: Ehime
city: Maebashi-Shi
country: Japan
facility: Local Institution
state: Gunma
city: Sunto-Gun
country: Japan
facility: Local Institution
state: Shizuoka
city: Osaka
country: Japan
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05864222: Aromatherapy and Happiness
Official title: Impact of Aromatherapy on Happiness and Job Satisfaction in Nurses Working in an Academic Health System (AHS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Happiness
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2023-05-18
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to explore the impact that aromatherapy has on nurses' self-perception of happiness and workplace satisfaction. After completing the informed consent process, participants will complete a demographic survey, the Oxford Happiness Questionnaire (OHQ), and the Nursing Job Satisfaction Survey (NJSS). Aromatherapy (AT), via AT stickers on employee badges, will begin after baseline measurements. OHQ and NJSS will be measured again at 3 months and 6 months of AT. After completion of the intervention, participants will also complete a qualitative survey addressing overall self-reported impact of AT. Analysis will occur after final data is collected.


Eligibility criteria: Inclusion Criteria:

1. A Registered Nurse at NYULH
2. Willing to provide an email address of choice
3. Willing to wear an aromatherapy badge sticker during every work shift
4. Not allergic or otherwise sensitive to aromatherapy scent

Exclusion Criteria:

1. Not a Registered Nurse at NYULH
2. Not willing to provide an email of choice
3. Not willing to wear an aromatherapy badge sticker during every work shift
4. Allergic or otherwise sensitive to aromatherapy scent

Primary outcomes:
measure: Change in Nursing Job Satisfaction Survey (NJSS) Score
timeFrame: Baseline, Month 6
measure: Change in Oxford Happiness Questionnaire (OHQ) Score
timeFrame: Baseline, Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Kathleen E Zavotsky
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00544622: Structured Stroke Management Improves Outcome at 6 Months
Official title: Structured Stroke Management Improves Outcome at 6 Months
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Stroke treatment
Rehabilitation
Stroke chain
Stroke unit
Lead sponsor: Kantonsspital Baden
Sponsor class: OTHER
Collaborators: name: 407 Doctors
First posted: 2007-10-16
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: Background/Aim of the study: To further reduce the 6 months stroke morbidity and mortality in a high volume stroke hospital and to compare the results with national and international data.

Methods: 204 consecutive stroke patients are analyzed in a prospective study in a single center teaching institution. The intervention consists of a structured therapeutic chain of 290 collaborating GPs, a standardised acute hospital proceeding overlapping with an early integrated neurovascular rehabilitation within the same institution. Primary endpoints include death and dependence at 6 months, secondary endpoints are the length of hospital stay (LOS) and the quantitative analysis of physical and psychosocial impairments. The data are directly compared with the same endpoints of the Swiss subgroup of the international stroke trial (IST).


Eligibility criteria: Inclusion Criteria:

* An acute cerebrovascular event (ischemic stroke or intra-cerebral bleeding (ICB)) with the signs and symptoms of an acute stroke according to the World Health Organisation definition of acute stroke14 within the last 12 hours without the need or possibility of a neurosurgical intervention
* No thrombolytic therapy within the first 3 hours (in order to allow the correct comparison with the Swiss cohort of the IST trial
* The informed consent of the patient or, if not possible, of the relatives
* Living at home before the event
* Lack of participation in another trial.

Exclusion Criteria:

* Thrombolytic therapy within the first 3 hours (in order to allow the correct comparison with the Swiss cohort of the IST trial
* No informed consent of the patient or, if not possible, of the relatives
* Not living at home before the event
* Participation in another trial (26 patients were excluded because of TIA with full recovery within 24 hours after the event)

Primary outcomes:
measure: Mortality, dependence, psychoscial outcome
measure: Mortality, dependence and psychosocial outcome
timeFrame: 6 months endpoint
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department of Medicine
name: Juerg H. Beer, MD
role: STUDY_CHAIR
References:
citation: Langhorne P, Ramachandra S; Stroke Unit Trialists' Collaboration. Organised inpatient (stroke unit) care for stroke: network meta-analysis. Cochrane Database Syst Rev. 2020 Apr 23;4(4):CD000197. doi: 10.1002/14651858.CD000197.pub4.