louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02107313: Phase 1 Study to Determine the Effects of Food on the Pharmacokinetic Profile of PBT2
Official title: A Phase 1, Single Centre, Randomised, 2 Period Crossover Study to Determine the Effect of Food on the Pharmacokinetic Profile of a Single Dose of PBT2 Administered Orally to Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Pranabio
Sponsor class: UNKNOWN
First posted: 2014-04-08
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to determine the pharmacokinetic (PK) profile of a single oral dose of PBT2 administered to healthy volunteers in the presence and absence of food.

Detailed description: The study will be conducted in 2 dosing periods, with participants being randomised to receive PBT2 250 mg with or without food in the first dosing period, followed by a 7 day washout period before receiving the opposite fed/fasted condition to that allocated in the first dosing period. Pharmacokinetic samples will be collected during each dosing period, along with safety monitoring assessments.

Eligibility criteria: Inclusion Criteria:

* Healthy male or females with a BMI between 19 and 30kg/m2
* No clinically significant abnormalities

Exclusion Criteria:

* Exposure to medications/drugs that interfere with metabolism of PBT2 including drugs that inhibit or induce CYP1A2)
* Use of caffeine-containing beverages, supplements or alcohol within 72 hours of study entry
* Significant history of depression or other psychiatric illness
* Surgical or medical conditions which could significantly alter drug absorption, distribution, metabolism or excretion
* unable to swallow capsules

Primary outcomes:
measure: Area Under the Concentration-Time Curve (AUC 0-t)
timeFrame: prior to the initial doses on day 1 and 8 and then 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 4.5, 5, 5.5, 6, 8,10,12,16, 24, 30, 36, 48 hours post each dose
Secondary outcomes:
measure: Safety and Tolerability of PBT2 in Healthy Volunteers Measured by the Number of Participants Reporting at Least One Treatment Emergent Adverse Events
timeFrame: Up to 15 days after the first dose of PBT2
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Centre for Clinical Studies - Nucleus Network
state: Victoria
Study officials:
affiliation: Prana Biotechnology
name: Caroline Herd
role: STUDY_DIRECTOR
References:
Clinical trial NCT02429713: The Effects of Tourniquet Use in Total Knee Arthroplasty
Official title: The Effects of Tourniquet Use in Total Knee Arthroplasty: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Loss
Keywords: tourniquet
total knee arthroplasty
blood loss
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2015-04-29
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Tourniquets are still widely used in total knee arthroplasty, but are associated with several adverse effects. Most of previous studies did not randomize the participants so the baseline difference of the patients might have influenced the outcome. Therefore, investigators conducted a randomized controlled trial, in which all the patients received staged bilateral TKA with two different durations of tourniquet use. Investigators aimed to quantify the effect of tourniquet use on reducing blood loss and to evaluate the impact of tourniquet use on functional and clinical outcome.

Detailed description: Fifty participants who underwent staged bilateral TKA were recruited in this study. On one side, the tourniquet was inflated immediately before incision and deflated after the hardening of the cement. On the other side the tourniquet was inflated immediately before cement application and deflated after its hardening. Blood loss, operating time, transfusion rate, postoperative pain, limb swelling, deep vein thrombosis (DVT) incidence and clinical outcomes were monitored for comparison.

Eligibility criteria: Inclusion Criteria:

* patients aged 50 years or over
* classified as American Society of Anesthesiologists ASA 1-2.

Exclusion Criteria:

* coagulopathy,
* uncontrolled hypertension,
* peripheral vascular disease and
* patients with BMI≥35

Primary outcomes:
measure: Intraoperative blood loss
timeFrame: within operation
Secondary outcomes:
measure: Thigh pain measured by Visual Analogue Scale/Score (VAS)
timeFrame: 1 day, 2 day, 1 week, 2 week and 6 week after surgery
measure: Thigh swelling measured by circumference 10 cm proximal to the patella
timeFrame: 1 day, 2 day, 1week, 2 week and 6 week after surgery
measure: Postoperative blood loss measured by drainage volume
timeFrame: 1 day and 2 day after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Peking University People's Hospital
name: Jianhao Lin, M.D.
role: STUDY_DIRECTOR
References:
citation: Tai TW, Lin CJ, Jou IM, Chang CW, Lai KA, Yang CY. Tourniquet use in total knee arthroplasty: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2011 Jul;19(7):1121-30. doi: 10.1007/s00167-010-1342-7. Epub 2010 Dec 15.
citation: Hernandez AJ, Almeida AM, Favaro E, Sguizzato GT. The influence of tourniquet use and operative time on the incidence of deep vein thrombosis in total knee arthroplasty. Clinics (Sao Paulo). 2012 Sep;67(9):1053-7. doi: 10.6061/clinics/2012(09)12.
Clinical trial NCT00969813: A Safety and Tolerability Study of CP-690,550 in Subjects With Hepatic Impairment and Normal Hepatic Function
Official title: A Phase 1, Non-Randomized, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CP-690,550 in Subjects With Hepatic Impairment and Normal Hepatic Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Insufficiency
Keywords: Hepatic impairment
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-09-01
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study is designed to evaluate how CP-690,550 is handled by the body in healthy volunteers who have mild and moderate hepatic impairment compared to healthy volunteers with normal hepatic function. This study will also evaluate the safety and tolerability of CP-690,550.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers who have normal liver function, and subjects who have either mild or moderate liver impairment.

Exclusion Criteria:

* Subjects with severe liver impairment
* Subjects who have weakened immune systems

Primary outcomes:
measure: Pharmacokinetics of CP-690,550 in subjects with hepatic impairment compared to subjects with normal hepatic function
timeFrame: 3 days
Secondary outcomes:
measure: Safety and tolerability of CP-690,550 in subjects with hepatic impairment compared to subjects with normal hepatic function
timeFrame: 10-14 days
Other outcomes:
Locations:
city: South Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Lawendy N, Lamba M, Chan G, Wang R, Alvey CW, Krishnaswami S. The effect of mild and moderate hepatic impairment on the pharmacokinetics of tofacitinib, an orally active Janus kinase inhibitor. Clin Pharmacol Drug Dev. 2014 Nov;3(6):421-7. doi: 10.1002/cpdd.143. Epub 2014 Oct 1.
Clinical trial NCT00640913: Early Reversal of Defunctioning Stoma Trial
Official title: Early Reversal of Defunctioning Stoma Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rectal Cancer
Keywords: Defunctioning stoma
Low anterior resection
TME surgery
Early stoma reversal
Lead sponsor: Rectal Cancer Trial on Defunctioning Stoma Study Group
Sponsor class: OTHER
First posted: 2008-03-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Twenty patients operated on with low anterior resection of the rectum for cancer and a defunctioning loop stoma.

Brief summary: In this trial will be investigated if a defunctioning loop stoma used in low anterior resection of the rectum for cancer can be reversed after 14 days instead of 3-12 months which is present clinical practise.

Detailed description: Patients undergoing low anterior resection of the the rectum for adenocarcinom (total mesorectal excision; TME) with a defunctioning loop stoma are assessed preoperatively and for 6 days postoperatively according to a trial protocol including daily clinical, physiological, and serological variables, and a rectal contrast study on day 6. If inclusion criteria are fulfilled, a decision is taken on day 7 to schedule reversal of the defunctioning loop stoma on postoperative day 14. This trial is considered a hypothesis generating pilot study of feasibility type and is no power calculation. The present trial will include 20 consecutive patients who accept participation.

Eligibility criteria: Inclusion Criteria:

* Written consent and fulfilled inclusion criteria preoperatively and during postoperative day 1-6.

Exclusion Criteria:

* Written consent and/or inclusion criteria not fulfilled preoperatively and during postoperative day 1-6.

Primary outcomes:
measure: Reversal of defunctioning loop stoma on postoperative day 14 following low anterior resection of the rectum for cancer with or without preoperative adjuvant treatment
timeFrame: Preoperatively, postoperative day 7, postoperative day 30 and at 6 months postoperatively
Secondary outcomes:
measure: Postoperative 30 day morbidity. Postoperative ano-rectal function at 1 and 6 months.
timeFrame: Postoperatively at 1 and 6 months.
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Department of Surgery, Örebro University Hospital
Study officials:
affiliation: Department of Surgery, Örebro University Hospital
name: Peter Matthiessen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05177913: Assessment of Factors Influencing Parents' Attendance Time During Feeding Time of Premature Infants Born Before 35 Weeks of Amenorrhea in Besançon University Hospital
Official title: Assessment of Factors Influencing Parents' Attendance Time During Feeding Time of Premature Infants Born Before 35 Weeks of Amenorrhea in Besançon University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Birth
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 75
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The premature newborn born before 35 weeks of amenorrhea at the Besançon University Hospital and his parents (birth couple).

Brief summary: The precise description of parental presence and the associated factors will make it possible to construct an intervention in order to correct potentially low parental participation. The demonstration of the effectiveness of such an intervention will be the subject of a larger study (PHRIP type). Ultimately, the investigators want to personalize the daily support for parents to offer optimal support for parenting.

Detailed description: Considering the importance of the bond of attachment, and in particular the emotional tuning between the adult and the premature baby and the particularly important interactions during feeding, it seemed essential to us to make an evaluation of the parental presence during the meals. , which sheds light on the factors influencing this presence.

The presence time seems to vary depending on: the child's background, the profile of the parents, the profile of the child and environmental factors.

Knowing the factors influencing this presence is essential in order to understand the obstacles to the arrival of parents, to think as a team and to offer personalized support in order to allow them to be more present with their baby.

Eligibility criteria: Inclusion Criteria:

* Premature newborn under 35 weeks of amenorrhea (AS), hospitalized at Besançon University Hospital,
* Newborn baby whose parents:

expressed their non-opposition to participate in the study, are affiliated to a social security scheme, are of age, express themselves easily in French.

Exclusion Criteria:

* Newborn baby whose parents object to participating in the study,
* Newborns presenting severe malformative anomalies, or malformations of the oral sphere,
* Newborn baby whose transfer is scheduled before the end of hospitalization (excluding birthing pool at the CHU de Besançon).

Primary outcomes:
measure: The time of parental presence
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besancon
Study officials:
References:
Clinical trial NCT01722513: Efficacy and Safety of Alprostadil Prevent Contrast Induced Nephropathy
Official title: Phase 4 Study of Alprostadil Prevent Contrast Induced Nephropathy in Patients Receiving a Cardiac Catheterization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Kidney Diseases
Diabetes Mellitus
Acute Kidney Injury
Kidney Failure, Chronic
Renal Insufficiency
Keywords: Contrast Induced Nephropathy
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2012-11-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this prospective, randomized, controlled study is to investigate the effect of pretreatment with intravenous Alprostadil on the incidence of CIN in a high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary angiography, and evaluate the influence of such potential benefit on short-term outcome.

Detailed description: The number of cardiac angiography and percutaneous coronary interventions (PCI) has increased steadily in recent years. This has resulted in the increasing incidence of contrast-induced nephropathy (CIN). Major risk factors for CIN include older age, diabetes mellitus (DM), chronic kidney disease (CKD).

The aim of this prospective, randomized, controlled study is to investigate the effect of pretreatment with intravenous Alprostadil on the incidence of CIN in a high-risk population of patients with both type 2 diabetes mellitus (T2DM) and CKD undergoing coronary angiography, and evaluate the influence of such potential benefit on short-term outcome.

Eligibility criteria: Inclusion Criteria:

* Patient that underwent coronary angiography
* T2DM
* CKD stages 2 and 3, eGFR 30 to 89ml/min per 1.73m2
* Alprostadil naive, or not on Alprostadil treatment for at least 14 days
* Withdrawal metformin or aminophylline for 48h before angiography

Exclusion Criteria:

* serum Cr. More than 3 mg/dl
* electrolyte and acid-base imbalance
* pulmonary edema
* allergy to Alprostadil

Primary outcomes:
measure: Primary Outcome
timeFrame: 72 h
Secondary outcomes:
measure: Secondary Outcome
timeFrame: 30 d
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Cardiology, Shanghai Tenth People's Hospital
state: Shanghai
Study officials:
affiliation: Department of Cardiology, Shanghai Tenth People's Hospital, Tongji University School of Medicine
name: Ya-Wei Xu, MD, FACC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koch JA, Plum J, Grabensee B, Modder U. Prostaglandin E1: a new agent for the prevention of renal dysfunction in high risk patients caused by radiocontrast media? PGE1 Study Group. Nephrol Dial Transplant. 2000 Jan;15(1):43-9. doi: 10.1093/ndt/15.1.43.
Clinical trial NCT02187913: Effects of Resistant Starch in a Baked Snack Bar on a Post-prandial Glycemic and Insulinemic Response
Official title: Effects of Resistant Starch in a Baked Snack Bar on a Post-prandial Glycemic and Insulinemic Response
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperglycemia, Diabetes, and Obesity
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2014-07-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: * About two-thirds of adults in the United States are overweight or obese which can cause adverse health consequences for those individuals. Post-prandial hyperglycemia is one of these possible consequences and is associated with a higher risk for Type 2 Diabetes. Controlling hyperglycemia is important in the prevention of the onset of diabetes and obesity. Resistant starch is a dietary carbohydrate which is not completely digested in the gut and produces energy for the body to use. The investigators are interested in assessing the effects of resistant starch on postprandial blood glucose and insulin concentrations.
* Aim: To assess the effects of a resistant starch on post-prandial blood glucose and insulin concentrations.
* Hypothesis: A baked snack bar with a resistant starch will blunt and sustain the post-prandial rise in blood glucose and insulin concentrations compared to a baked snack bar with maltodextrin (an easily digested carbohydrate).


Eligibility criteria: Inclusion Criteria:

* Thirty healthy men and women (aged 18-29y) will be recruited from the greater Lafayette, IN region with the expectation that ≥20 subjects will complete the study. Subjects must weigh \>110 pounds, with a BMI between 20.0 and 29.9.

Exclusion Criteria:

* Weight change \> 3kg in the past 3 months
* Exercising vigorously over the past 3 months as well as no exercise 3 days prior to testing day
* Intestinal disorders including lipid mal-absorption or lactose intolerance
* Abnormal liver or kidney function tests; fasting blood glucose \>100mg/dL
* Smoking
* Drinking more than 2 alcoholic drinks per day
* Taking lipid-lowering medications or dietary supplements affecting plasma cholesterol concentration.
* Subjects must not be pregnant or lactating.

Primary outcomes:
measure: resistant starch effects
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
References:
Clinical trial NCT05587413: Effectiveness of Periodontal Treatment for the Glycemic Conttrol of Type II Diabetes Mellitus
Official title: Effectiveness of Periodontal Treatment for the Glycemic Conttrol of Type II Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient Compliance
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 112
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The project is intended to find out the effect of Periodontal treatment for the glycemic control of type II diabetes mellitus patients.


Eligibility criteria: Inclusion Criteria:

1. Patients having Diabetes Mellitus and diagnosed with Periodontitis for last six months.
2. Aged between 30-60 years.
3. Patients with HbA1C level 7-9.5%, measured within three months prior to present study.

Exclusion Criteria:

1. Patients with acute oral infection
2. Need for immediate tooth extractions
3. Severe Hypertension (\>180/110 mm Hg)
4. Edentulous Patients
5. Patients with Diabetic Nephropathy
6. Patients with Diabetic Retinopathy

Primary outcomes:
measure: Change of HbA1C between the control group and interventional group.
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Uol
state: Punjab
Study officials:
References:
Clinical trial NCT03523013: The Outcome of CPAP Titration Under Sleep Endoscopy
Official title: The Outcome of CPAP Titration Under Sleep Endoscopy: A Randomized Controlled Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
CPAP
DISE
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 24
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: DIAGNOSTIC

Brief summary: The outcome of CPAP titration under sleep endoscopy: A randomized controlled crossover trial

Detailed description: This is the study entitled "The outcome of CPAP titration under sleep endoscopy: A randomized controlled crossover trial". CPAP is first line golden standard treatment for Obstructive sleep apnea (OSA). However, the overall CPAP compliance is about 50%. One of the reasons responsible for the poor compliance is the inadequate pressure setting initially. Therefore, it is crucial for us to find out the adequate pressure as soon as possible. Sleep endoscopy is the way to evaluate upper airway obstruction of OSA patients. Meanwhile, the investigators used CPAP to titrate the adequate pressure to keep upper airway open under sleep endoscopy guidance. While the investigators find out this adequate pressure, the investigators set this pressure into CPAP program, which OSA patient will use for 1 month. To compare the different effect of CPAP under either auto-CPAP titration pressure or sleep endoscopy guidance pressure, those OSA patients will use auto-titration CPAP for 1 month as well. Another highlight of this study is the sedative agent-dexmedetomidine. Dexmedetomidine is a α2 antogonist, which cause patients sedative but less respiratory drive suppression. The mechanism of dexmedetomidine is more physiological for nature sleep.

Eligibility criteria: Inclusion Criteria:

* moderate to severe OSA
* ESS \>10

Exclusion Criteria:

* ASA \> 3
* allergy to Dexmedetomidine
* second or third degree AVB
* severe heart failure Fc class IV
* asthma acute attack

Primary outcomes:
measure: complaince of CPAP use
timeFrame: the change of complaince between baseline, 1 month and 2 months
Secondary outcomes:
measure: sleepiness score
timeFrame: the change of ESS between baseline, 1 month and 2 months
Other outcomes:
measure: sleep quality
timeFrame: the change of PSQ between baseline, 1 month and 2 months
Locations:
city: Taipei
country: Taiwan
facility: Division of Thoracic Medicine, Chang Gung Memorial Hospital
Study officials:
References:
citation: Wang TY, Huang YC, Lin TY, Ni YL, Lo YL. Outcome of CPAP Titration for Moderate-to-Severe OSA Under Drug-Induced Sleep Endoscopy: A Randomized Controlled Crossover Trial. Front Neurol. 2022 Jun 13;13:882465. doi: 10.3389/fneur.2022.882465. eCollection 2022.