louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01863355: Comparison of Analgesic Efficacy and Occurrence of Emesis Among Different Background Infusion and Bolus Administration Regimens of Fentanyl Based Intravenous Patient-controlled Analgesia in Patients After Laparoscopic Assisted Gastrectomy - a Randomized Blind Study -
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: The Patients With Gastric Cancer Who Are Scheduled to Receive Laparoscopy Assisted Gastrectomy
Keywords: IntravenousPCA, fentanyl, postoperative pain, laparoscopic gastrectomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-05-27
Enrollment: 225
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: Fentanyl based intravenous patient controlled analgesia(PCA)is popular method for postoperative pain control, but information regarding optimal dose of fentanyl in IV PCA is currently lacking. We thus determine appropriate dose of fentanyl (bolus dose and background infusion rate) for effective pain control with minimal side effects such as nausea and vomiting


Eligibility criteria: Inclusion Criteria:

* Age between 20 and 70
* ASA class I and II
* Gastric cancer patients who are scheduled to receive laparoscopic gastrectomy

Exclusion Criteria:

* Cardiovascular disease(uncontrolled hypertension, unstable angina, congestive heart failure, etc.)
* Renal failure
* Liver failure
* Chronic drug or alcohol abuser
* Anti-cancer chemotherapy
* Chronic opioid use
* Use of antiemetics within 24hrs for nausea and vomiting

Primary outcomes:
measure: Pain score(VAS) within 48hrs after surgery
timeFrame: Pain socre after surgery 1) within 30min-6hrs, 2) within 6-24hrs, 3) within 24hrs-48hrs
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
Study officials:
References:
Clinical trial NCT00439855: Enoxaparin Versus Unfractionated Heparin in PCI
Official title: Enoxaparin Versus Unfractionated Heparin in PCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Enoxaparin, heparin, hemorrhages
Lead sponsor: Triemli Hospital
Sponsor class: OTHER
First posted: 2007-02-26
Enrollment: 2100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Enoxaparin 0.75mg/kg BW is not inferior to weight adjusted unfractionated heparin as anticoagulation for PCI


Eligibility criteria: Inclusion Criteria:

* PCI for stable ischemia or ACS

Exclusion Criteria:

* Cardiogenic shock,
* Pretreatment with study drugs,
* Lack of informed consent

Primary outcomes:
measure: Quadruple endpoint: death, MI, urgent TVR, major bleeding
Secondary outcomes:
measure: major bleeding, minor bleeding, thrombocytopenia
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Division of Cardiology Triemli Hospital Zurich
Study officials:
affiliation: Division of Cardiology Triemli Hospital Zurich
name: osmund bertel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03628755: Effectiveness of Digital Manipulation of Thyroid Cartilage and Fluency Shaping Therapy for the Management of Stuttering in Adult
Official title: Effectiveness of Digital Manipulation of Thyroid Cartilage and Fluency Shaping Therapy for the Management of Stuttering in Adult
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Developmental Stuttering
Keywords: Fluency shaping therapy
Digital Manipulation
Stuttering
communication
Lead sponsor: Isra University
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The three group were digital manipulation of thyroid cartilage(DMT) group,fluency shaping therapy (FST) group,combination of DMT,FST. the intervention period for each subject was three month and data was collected on day one and at the end of every 2 weeks. 4th week , 8th week, and 12th week which were aimed to reduce severity of stuttering and improve fluency
Primary purpose: PREVENTION

Brief summary: This study was conducted to determine the effectiveness of digital manipulation of thyroid cartilage for the management of stuttering in adult.There were three groups,Group A received Digital Manipulation of Thyroid cartilage (DMT),Group B received Fluency shaping Therapy(FST),Group C received combination of DMT,FST.

Detailed description: The purpose of speech therapy is to stop progression of stuttering while teaching the method to client how to cope efficiently his or her stuttering disorder.

The goal of fluency shaping therapy to eliminate the severity of stuttering by adopting the specific pattern of speech production and also reduce negative reaction to stuttering by default).

Digital manipulation of thyroid cartilage decreases tension in vocal fold and reduces severity of stuttering and improves production of speech. DMT reduces unnecessary amount of tension in vocal tract and participant speaks with relax respiration,phonation, articulation and facilitate more fluent.in DMT subject speaks in natural way rather than in specific method in every situation.

Eligibility criteria: Inclusion Criteria:

* Developmental stuttering
* Between age of 18 to 30 years
* Only male

Exclusion Criteria:

* Language disorders
* Cluttering
* Neurological stuttering

Primary outcomes:
measure: Scale for Rating the severity of stuttering
timeFrame: 12 weeks
measure: Modified Erickson scale of communication attitude(24)
timeFrame: 12week
measure: Assessment of Physiological Factors Associated with Stuttering
timeFrame: 12 week
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: National Institute of Rehabilitation Medicine (NIRM)
state: Federal
Study officials:
References:
Clinical trial NCT06308055: Abiomed Impella RT-DAQ - Observational Study
Official title: Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiogenic Shock
Lead sponsor: Abiomed Inc.
Sponsor class: INDUSTRY
First posted: 2024-03-13
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring cardiac Impella pump-support and intensive care therapy including cardiac output monitoring, eg. by pulmonary artery catheter at some point of therapy.

Initially, a collection of 250 patient days is aimed for. It is expected that each patient will be monitored by PAC for at least 48 hours, thus approximately 125 patients will be needed to achieve study objectives.

Brief summary: Abiomed IMPELLA-RT-DAQ - Impella Real Time Data AcQuisition

Detailed description: The objective of this study is to develop algorithms for determining the cardiac output through the synchronous acquisition of hemodynamic data from the pulmonary artery catheter or other pressure sensors and Impella using a network module, which can replace invasive hemodynamic monitoring in the future.

Eligibility criteria: Inclusion Criteria:

1. Ongoing or planned intensive care management with Impella support
2. Presence or planned placement of a cardiac output measurement

   1. Preferentially pulmonary catheter (including cardiac output (CO) preferred as continuous measurement)
   2. Other means of discontinuous CO measurement incl. echocardiography, other thermodilution methods

Exclusion Criteria:

1. Age \< 18 years
2. Pregnancy
3. Anticipated support duration \<24 h

Primary outcomes:
measure: Collection of hemodynamic parameters (Cardiac Output in l/min)
timeFrame: From Impella insertion unitl Impella support is permanently weaned, on average 2 days
measure: Collection of hemodynamic parameters (Blood Pressure in mmHg, Pulmonary Artery Pressure in mmHg, Central Venous Pressure in mmHg, Pulmonary Capillary Wedge Pressure in mmHg)
timeFrame: From Impella insertion unitl Impella support is permanently weaned, on average 2 days
measure: Collection of hemodynamic parameters (Mixed Venous Saturation in %)
timeFrame: From Impella insertion unitl Impella support is permanently weaned, on average 2 days
measure: Collection of hemodynamic parameters (Pulmonary Vascular Resistance in In dynes/sec/cm-5 )
timeFrame: From Impella insertion unitl Impella support is permanently weaned, on average 2 days
Secondary outcomes:
measure: Rate of Patient Survival
timeFrame: Once the Impella support is permanently weaned, on average 2 days
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitätsspital Basel
Study officials:
affiliation: Uniklinik RWTH Aachen, Klinik für Kardiologie, Angiologie und Internistische Intensivmedizin
name: Alexander Kersten, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00913055: Open Label Study of Octreotide Implant in Patients With Acromegaly
Official title: An Open-Label Study to Evaluate the Pharmacokinetic and Pharmacodynamic Response of a Hydrated and Non-Hydrated 84mg Octreotide Implant in Patients With Acromegaly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acromegaly
Keywords: S-LAR
Octreotide
Implant
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-06-03
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) response of a hydrated and non-hydrated 84 mg octreotide implant in patients with acromegaly in the first 6 weeks of treatment.

Detailed description: An open-label, randomized, multi-center, parallel-group, Phase I/II study conducted in 30 male and female patients with acromegaly. Eligible patients received 1 implant, either hydrated or non-hydrated, within 7 days of their Screening Visit. The octreotide implant was inserted subcutaneously in the inner aspect of their non-dominant arm under local anesthesia. Blood samples for the determination of insulin-like growth factor 1 (IGF-1), growth hormone (GH), and octreotide serum concentrations were collected at predetermined timepoints within the first 6 weeks after implantation.

Eligibility criteria: Inclusion Criteria:

* Male and female patients with acromegaly
* Must be at least 18 years old
* Confirmed diagnosis of a growth hormone -secreting tumor
* Must be either a full or partial responder to octreotide demonstrated by historical laboratory values

Exclusion Criteria:

* Women who are pregnant, lactating or of child-bearing potential who are not practicing a medically acceptable method of birth control
* Patients with liver disease
* Patients with symptomatic cholelithiasis
* Patients receiving radiotherapy for their pituitary tumor at any time before Screening

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02770755: Registry of Celution Device for Processing ADRCs and Healing in Muscle and Ligament Sports Injuries
Official title: Registry of Celution Device for the Processing of Adipose Derived Regenerative Cells (ADRCs) and Healing in Muscle and Ligament Sports Injuries (ACHILLES)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Muscle Tear
Lead sponsor: Cytori Therapeutics
Sponsor class: INDUSTRY
First posted: 2016-05-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are scheduled to receive or have received Adipose Derived Regenerative Cells (ADRCs) prepared by Celution device to treat muscle and ligament sports injuries.

Brief summary: This registry study will compile information about patients who are scheduled to receive or have received Adipose Derived Regenerative cells (ADRCs) prepared by Celution device to treat muscle and ligament sports injuries.


Eligibility criteria: Inclusion Criteria:

* Males or females \> 18 of age
* Patients with sports related muscle tear (≥5%) with or without ligament injury as confirmed by ultrasound or MRI with onset of injury in preceding year
* Pain in the affected area at rest and/or movement
* Weakness or inability to use affected muscle

Exclusion Criteria:

* Muscle tear \<5% or unrepaired complete tears or ruptures on ultrasound or MRI
* Known spine or disc disease or symptomatic impingement of nerve root
* Known neuromuscular disease (e.g., amyotrophic lateral sclerosis, muscular dystrophy)
* History of documented nerve damage in the affected limb
* Tears involving open wounds
* Tears requiring surgical repair
* Pregnant or lactating status. Pregnancy as determined by a positive pregnancy test at screening or baseline

Primary outcomes:
measure: Change in magnitude of muscle tear as assessed by ultrasound or MRI
timeFrame: 42 days
Secondary outcomes:
measure: Change in magnitude of muscle tear as assessed by ultrasound or MRI
timeFrame: 21 days
measure: % of patients with complete healing as measured by ultrasound or MRI
timeFrame: Days 7, 14, 21, 42 and 90
measure: Change in pain
timeFrame: Days 7, 14, 21, 42 and 90
measure: Change in function
timeFrame: Days 7, 14, 21, 42 and 90
Other outcomes:
measure: Recurrent muscle tears
timeFrame: Days 7, 14, 21, 42 and 90
Locations:
city: Wembley
country: United Kingdom
facility: The Football Association
Study officials:
affiliation: Cytori Therapeutics
name: Steven Kesten, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT04515355: Preventing Job Loss Using Acceptance and Commitment Therapy in Vocational Rehabilitation
Official title: Preventing Job Loss Using Acceptance and Commitment Therapy in Vocational Rehabilitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2020-08-17
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: About 60-70% of people with multiple sclerosis (PwMS) lose employment within 10 years of the diagnosis. This can be due to complex personal and work-based factors including psychological factors. MS-PROACTIVE aims to test an online self-help therapy to support PwMS to stay in work called 'READY for MS'. This is a type of Acceptance and Commitment therapy. It is a way to provide treatment in a flexible way without people having to go to see a psychologist.

The aim of the treatment is to improve self-efficacy which has been shown to be a significant factor for helping PwMS who want to work to stay in work.

The research team will initially develop an online version of READY for MS. We will ask 4 PwMS to test the online'READY for MS' and provide feedback and advice on any necessary changes. We will then recruit and randomise 88 PwMS in Leeds and London who are at risk of job loss. Participants in the active treatment group will use the online treatment in addition to their usual care; the control group will receive their usual care. The participants will complete questionnaires at the start of the study, at 8 weeks and 6 months measuring time off work and work instability (to measure risk of job loss), self-efficacy, mood, quality of life, fatigue and the impact of MS. The questionnaire data will be analysed to test the effectiveness of the treatment. The research team will also interview 4 PwMS at each site at the start of the study, at 8 weeks and 6 months to find out about their experience of using READY for MS in more detail. This will help to inform the use of READY for MS in a larger trial in the future.


Eligibility criteria: Inclusion Criteria:

* Employed people with a confirmed diagnosis of multiple sclerosis. Paid employment including full-time or part-time work and self-employed. Age 18 years and over Access to a computer or tablet for the on-line sessions. Ability to complete questionnaires at three time points.

Exclusion Criteria:

* Unpaid employment eg voluntary work. PwMS who are planning to retire or fully leave employment in the time period of the RCT. On sick leave or maternity leave at the time of recruitment.

Significant cognitive impairment.

Primary outcomes:
measure: Completing the Ready for MS programme
timeFrame: 7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
state: West Yorkshire
Study officials:
References:
Clinical trial NCT01855555: The Incidence and Nature of Adverse Events During Pediatric Sedation for MRI/CT in One Korean University Hospital: Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children Requiring Sedation for MRI/CT
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 2948
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children requiring sedation for MRI/CT

Brief summary: Sedation and anesthesia for which to perform diagnostic imaging represents a rapidly growing field of practice, especially in children. Propofol is the most common sedative drug administered for MRI/CT. However, this drug is associated with adverse events, including pulmonary complications, and there has been no report on these complications in Korea. In this prospective observation study, the investigators will report the nature and frequency of adverse events associated with propofol-based sedation for MRI/CT.


Eligibility criteria: Inclusion Criteria:

* Requiring sedation for MRI/CT, aged 0- 18 years

Exclusion Criteria:

* Parent refusal of participation

Primary outcomes:
measure: Frequency of Adverse Events
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Cravero JP, Beach ML, Blike GT, Gallagher SM, Hertzog JH; Pediatric Sedation Research Consortium. The incidence and nature of adverse events during pediatric sedation/anesthesia with propofol for procedures outside the operating room: a report from the Pediatric Sedation Research Consortium. Anesth Analg. 2009 Mar;108(3):795-804. doi: 10.1213/ane.0b013e31818fc334.
Clinical trial NCT04330755: Levosimendan Versus Combination With Magnesium Sulphate on Spine Protection by NIRS in Infants Undergoing Coarctectomy
Official title: The Effect of Levosimendan Versus Its Combination to Magnesium Sulphate on Spinal Cord Protection Guided by NIRS in Infants Undergoing Coarctectomy: A Randomized Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Aortic Coarctation
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2020-04-01
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In pediatric patients ,undergoing elective surgical correction of aortic coarcatation one of our main concern is spinal cord protection .Our aim to study the protective effect of levosimendan versus its combination with magnesium sulphate .

Detailed description: Effect of levosimendan and its combination with magnesium sulphate infusion as spinal cord protection using NIRS values before Aortic cross clamp and 10,20 min after cross clamp till the end of surgery .

Eligibility criteria: Inclusion Criteria:

Age group ranging from 0 to 12 months of both sexes. Aortic coarcatation eligible for correction

Exclusion Criteria:

Parents or guardian refusal. Age more than12 months. Significant left ventricular dysfunction Patient with Heart block Patient with pre-existing CNS disorder eg seizure Patient with renal or hepatic dysfunction

Primary outcomes:
measure: Near Infrared Spectroscopy value
timeFrame: Perioperative(immediately before cross clamp,10&20 min after cross clamping Aorta)
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Sara ABD El-Salam
Study officials:
affiliation: Cairo University
name: Amel HY Abelala, professor
role: STUDY_CHAIR
References:
Clinical trial NCT00728455: Examination of the Safety and Tolerability of NNC 0070-0002-0349 in Overweight/Obese Volunteers
Official title: Single Subcutaneous Dose Rising Study to Investigate the Safety, Tolerability, Efficacy and Pharmacokinetics of NNC 0070-0002-0349 in Overweight/Obese Male Subjects
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Metabolism and Nutrition Disorder
Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-08-05
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial will be conducted in the United States of America (USA). The aim of this clinical trial is to investigate whether NNC 0070-0002-0349 is safe and well tolerated.

Groups of eight subjects will be administered subcutaneous injections of NNC 0070-0002-0349 or placebo on Day 1 beginning with a low dose; after which laboratory and vital sign data as well as subject reported adverse events will be evaluated. If safe to proceed, the next group of subjects will be given a higher dose and the safety evaluation performed again before proceeding. In total, 5 dose levels will be evaluated.

Subjects will be administered a dose and remain in the clinic until the morning of Day 8 after dosing and vital signs and safety labs as well as blood drawn for pharmacokinetic samples taken. Subjects will return to the clinic on Days 10, 12, 14, 16, 18 and 22 for repeat blood draws and safety labs. Day 22 is the final study visit.


Eligibility criteria: Inclusion Criteria:

* BMI greater than 27.0 and less than 35.0 kg/m2

Exclusion Criteria:

* Systolic blood pressure greater than 140 mm Hg or diastolic greater than 90 mm Hg
* Depression or suicidal thoughts (Scoring on Patient Health Questionnaire-9-item)
* Eating disorders
* Unusual diets or eating habits
* Dieting, use of diet drugs or obesity surgery
* Diabetes history or abnormal fasting glucose

Primary outcomes:
measure: Safety and tolerability (adverse events, vital signs, blood chemistry, physical examination, ECG)
timeFrame: Including screening and evaluation: after approx. 7 weeks
Secondary outcomes:
measure: AUC (area under the curve)
timeFrame: 21 days following dosing
measure: Maximum plasma concentration
timeFrame: 21 days following dosing
measure: Time to maximum plasma concentration
timeFrame: 21 days following dosing
measure: Half life
timeFrame: 21 days following dosing
Other outcomes:
Locations:
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: