louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00867204: Short Versus Long Wire ERCP Systems
Official title: Prospective Randomized Blinded Comparison of a Short-wire ERCP System to Traditional Long-wire Devices
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endoscopic Retrograde Cholangiopancreatography
Keywords: ERCP
Study focus was to compare the performance of the ERCP short-wire device versus the Long-wire device.
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2009-03-23
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with the clinical indication for an ERCP.

Brief summary: This study looked at short-wire ERCP devices versus Long-wire ERCP devices. The study hypothesis is to compare the performance of the Fusion ERCP short-wire system to the traditional Long-wire system.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing ERCP.

Exclusion Criteria:

* Age less than 18 years, pregnant women, patients unable to provide informed concent, prior surgery causing a significant change in the anatomy of the papilla (Billroth II or Roux-en-Y)

Primary outcomes:
measure: Time for device exchange and stent insertion
timeFrame: during the ERCP
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida/Shands UF Endoscopy Center
state: Florida
Study officials:
affiliation: University of Florida
name: Peter V Draganov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01458704: Cancer Genome Analysis
Official title: Cancer Genome Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malignant Tumor
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-10-25
Enrollment: 100
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 with malignant tumor receiving or planning to receive chemotherapy with fresh frozen tumor tissue with informed consent

Brief summary: Next generation sequencing (including targeted gene seqeuncing, exome and transcriptome sequencing) will be performed from fresh frozen tumor samples to understand the genetic alteration of tumors and to aid in optimal selection of further therapeutic agents.


Eligibility criteria: Inclusion Criteria:

* patients with malignant tumor
* receiving or planning to receive chemotherapy
* with fresh frozen tumor tissue
* with informed consent

Primary outcomes:
measure: targeted sequencing of cancer-relate genes
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Tae-You Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03100604: The Effect of General Anesthesia on the Middle Ear Pressure
Official title: Prospective, Single-blind Study Investigating the Effect of Sevoflurane and Desflurane, Agents Used in Patients on the MEP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ear Deformities, Acquired
Keywords: middle ear pressure
sevoflurane
desflurane
Lead sponsor: Trakya University
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aimed to examine the effect of sevoflurane and desflurane, agents used in patients who do not have any ear pathology and undergo surgery under general anesthesia, on the MEP.

Detailed description: Studies reported that inhalation agents are more likely to have impacts on the middle ear pressure compared to intravenous anesthetic agents. Despite numerous studies comparing the effects of inhalation agents on the middle ear pressure, this is the first clinical trial in which end tidal carbon dioxide and effects of sevoflurane and desflurane, along with other anesthetic analgesic agents used, on the middle ear pressure were compared. Our purpose in this study was to investigate the effect of sevoflurane and desflurane, inhalation agents used in patients who do not have any ear pathology and undergo non-ear surgery under general anesthesia, on the middle ear pressure.

Eligibility criteria: Inclusion Criteria:

* (ASA) II-III physical status
* elective inguinal hernia
* lower extremity surgery
* general anesthesia
* supine position

Exclusion Criteria:

* nasal septum,
* adenotonsillar hypertrophy,
* perforated tympanic membrane,
* middle ear pathology
* receive medications for middle ear pressure .

Primary outcomes:
measure: Middle ear pressure
timeFrame: postoperative 30th minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02736604: Evaluation of Impact of Nitrous Oxide on PONV in Breast Surgeries
Official title: Evaluation of Impact of Nitrous Oxide on PONV in Breast Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Tata Memorial Hospital
Sponsor class: OTHER_GOV
First posted: 2016-04-13
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postoperative nausea and vomiting (PONV) is considered one of the most unpleasant postoperative discomforts and lead to serious complications of aspiration of gastric contents, suture dehiscence, esophageal rupture, subcutaneous emphysema, or pneumothorax. The incidence of PONV is 30-40% in normal population and touches a peak of 75-80% in certain high-risk groups. PONV is associated with delayed recovery and prolonged hospital stay and is associated with significant morbidity. It may also result in delayed discharge, which is particularly significant after potentially ambulatory surgery. Women are 2 to 3 times more susceptible to PONV than men and breast surgery, which is primarily done in an outpatient setting, is associated with high incidence of PONV, ranging between 15% and 84% in the absence of prophylactic treatment.

Nitrous oxide (N2O) has analgesic and sedative properties but may potentially increase the incidence of PONV. N2O might increase the incidence of PONV by several potential mechanisms: (1) increase in middle ear pressure (2) bowel distension, (3) activation of the dopaminergic system in the chemoreceptor trigger zone and (4) interaction with opioid receptors. N2O has been demonstrated to increase the incidence of PONV in some studies but not in others. The present study is undertaken to evaluate the effect of nitrous oxide- free general anesthesia on the undesirable clinical outcome of PONV.


Eligibility criteria: Inclusion Criteria:

1. ASA I and II female patients aged 18 years or over posted for Breast Surgeries under General Anesthesia in the main operating rooms

Exclusion Criteria:

1. ASA III, IV, V female patients
2. Age less than 18 years
3. Patients undergoing Breast Reconstructive Surgery
4. Patients with contraindications to Fentanyl, Diclofenac, Paracetamol, Atracurium
5. Chronic pain patients on long-term opioid medication
6. Use of regional anesthetic technique (e.g. Paravertebral Block)

Primary outcomes:
measure: incidence and severity of post operative nausea and vomiting
timeFrame: up to 24 hours after surgery
Secondary outcomes:
measure: measurement of pain score and analgesic requirements
timeFrame: up to 24 hours after surgery
measure: Airway device cuff pressures
timeFrame: During the surgery
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Tata Memorial Hospital
state: Maharashtra
Study officials:
affiliation: Department of Anaesthesia, Critical Care and Pain, Tata Memorial Hospital, parel, mumbai, India
name: vijaya p patil, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04048304: Short Post-surgical Antibiotic Therapy in Spine Infections - a Prospective, Randomized, Unblinded, Non-inferiority Trial
Official title: Short Post-surgical Antibiotic Therapy in Spine Infections - a Pro-spective, Randomized, Unblinded, Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infection
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2019-08-07
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomization
Primary purpose: TREATMENT

Brief summary: We implement a prospective, randomized, unblinded, non-inferiority trial regarding the duration of systemic, targeted antibiotic therapy after the first surgical debridement for spine infection; randomizing 1:1 between

1. Six and twelve weeks of antibiotic therapy if there is an implant left in place
2. Three and six weeks of antibiotic therapy if there is no implant left


Eligibility criteria: Inclusion Criteria:

* Spine surgery and intraoperative debridement with any technique
* At least 12 months of scheduled follow-up from hospitalization
* Bacterial spine infection of any nature, independently of implants or co-morbidities

Exclusion Criteria:

* Mycobacterial, fungal, nocardial, and Actinomyces infections in the spine
* Non-resected cancer in the infection site
* Bone marrow or recent solid organ transplant patient (Recent: \<5 years)
* Any other infection in the patient requiring more than 6 weeks of antibiotic therapy
* More than three intraoperative debridements performed for spine infection
* Absence of at least one surgical intraoperative debridement of infection

Primary outcomes:
measure: Remission of infection at 12 months after treatment
timeFrame: 12 months after treatment
Secondary outcomes:
measure: costs
timeFrame: up to 12 months
measure: duration of sick leave
timeFrame: up to 12 months
measure: length of hospital stay
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Balgrist University Hospital
state: Zurich
Study officials:
affiliation: Balgrist University Hospital
name: Ilker Uckay, PD Dr med
role: STUDY_DIRECTOR
References:
citation: Betz M, Uckay I, Schupbach R, Grober T, Botter SM, Burkhard J, Holy D, Achermann Y, Farshad M. Short postsurgical antibiotic therapy for spinal infections: protocol of prospective, randomized, unblinded, noninferiority trials (SASI trials). Trials. 2020 Feb 6;21(1):144. doi: 10.1186/s13063-020-4047-3.
Clinical trial NCT05626504: Outcome Study of the Pipeline Embolization Device With Vantage Technology in Unruptured Aneurysms
Official title: Outcome Study of the Pipeline Embolization Device With Vantage Technology in Unruptured Aneurysms
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Brain Aneurysm
Intracranial Hemorrhages
Stroke
Lead sponsor: King's College Hospital NHS Trust
Sponsor class: OTHER
First posted: 2022-11-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients Treated with pipeline embolization devices during 2021 and 2022

Brief summary: In this project the investigators study the safety and efficacy of the pipeline embolization device with vantage technology in treatment of unruptured brain aneurysms


Eligibility criteria: Inclusion Criteria:

* All patients treated with Pipeline Embolization Device with Vantage Technology (PEDV)
* MRA and/or DSA (or tomographic angiography) available for follow up

Exclusion Criteria:

* Insufficient background data available e.g., to determine size of aneurysm and pipeline device
* PEDV used for causes other than aneurysms, e.g., fistulas and dissection.

Primary outcomes:
measure: Evaluate 30-day morbidity rates
timeFrame: Done at 30 days post procedural
measure: Evaluate 30-day mortality rates
timeFrame: Done at 30 days post procedural
Secondary outcomes:
measure: Evaluate 1-year morbidity rates
timeFrame: Done at >30days up to 1 year post procedural
measure: Evaluate 1-year mortality rates
timeFrame: Done at >30days up to 1 year post procedural
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Kings College Hospital
Study officials:
References:
citation: Atasoy D, Kandasamy N, Hart J, Lynch J, Yang SH, Walsh D, Tolias C, Booth TC. Outcome Study of the Pipeline Embolization Device with Shield Technology in Unruptured Aneurysms (PEDSU). AJNR Am J Neuroradiol. 2019 Dec;40(12):2094-2101. doi: 10.3174/ajnr.A6314. Epub 2019 Nov 14.
Clinical trial NCT03020004: Efficacy and Safety of Danoprevir/r + PR 12-week Triple Therapy in Treatment-Naive, Non-Cirrhotic, G1 CHC China II
Official title: A Phase 2,Multicenter,Open-Label Study to Investigate the Efficacy, Safety and Pharmacokinetics of Ritonavir-boosted Danoprevir in Combination With Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis GT1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Keywords: Danoprevir
SVR12
Chinese HCV G1
non-cirrhotic
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
First posted: 2017-01-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the Efficacy, Safety and Pharmacokinetics of Ritonavir-boosted Danoprevir (ASC08) in Combination with Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1.


Eligibility criteria: Inclusion Criteria:

* Willing and able to provide written informed consent
* Chronic HCV infection (≥ 6 months) ;
* Positive HCV antibody
* Serum HCV RNA of ≥ 1 × 104 IU/mL
* Hepatitis C virus GT1
* Never received prior-treatment for HCV with interferon, RBV, or other direct-acting or host-targeting antivirals for HCV
* The liver biopsy methods in the protocol (non-cirrhosis is defined as: Metavir score ˂ 4), or as determined by Fibroscan defined as: ˂ 14.6 kPa. Patients who have not obtained a liver biopsy or Fibroscan in the last 1 years will have a study related Fibroscan performed in order to confirm the diagnosis
* Others as specified in the detailed protocol

Exclusion Criteria:

* Patients with Fibroscan detection value \> 12.9 kPa, or histologic examination for liver cirrhosis patients
* Presence or history of non-hepatitis C chronic liver disease, including but not limited to, autoimmune hepatitis, α-1-antitrypsin deficiency, C282Y homozygous hemochromatosis, Wilson's disease, drug- or toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis, sclerosing cholangitis, and porphyria cutanea tarda causing liver pathology or requiring phlebotomy
* Patients with a history of liver cell cancer, screening before or screening suspected hepatocellular carcinoma (HCC) patients, or imaging studies found suspicious nodules, or AFP \> 50 ng/mL
* Positive hepatitis A antibody，positive hepatitis B surface antigen，syphilis antibody or HIV antibody at screening
* Others as specified in the detailed protocol

Primary outcomes:
measure: Percentage of Subjects With Sustained Virologic Response (SVR12) 12 Weeks Post-treatment
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ascletis Pharmaceuticals Co., Ltd.
name: Huoling Tang, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02757404: Meditoxin® Treatment in Patients With Post Stroke Upper Limb Spasticity
Official title: Impact of Injection Techniques on the Effectiveness of Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Muscle Spasticity
Keywords: botulinum toxin
spasticity
injection technique
neuronox
meditoxin
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2016-05-02
Enrollment: 59
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity.

Detailed description: This study is "A Multicenter, Prospective, Randomized, Evaluator Blinded, Comparing Phase 4 Study to Evaluate the Impact of Injection Techniques on the Effectiveness of Botulinum Toxin for the Treatment of Post Stroke Upper Limb Spasticity".

Eligibility criteria: Inclusion Criteria:

1. Male or female subject aged over 20.
2. Subjects who has grade 1 + and more spasticity at least one of upper limb muscles as measured on Modified Ashworth Scale after stroke.
3. Subjects who was diagnosed stroke at least 1 month prior to study participation.
4. Subjects or legal representatives who voluntarily decided the participation of the study and signed the informed consent.

Exclusion Criteria:

1. Subjects who had spinal injuries to be a factor of spasticity except for stroke prior to study enrollment.
2. Subjects with allergy or hypersensitivity to the Botulinum Toxin.
3. Subjects who have changed the muscle relaxant taking for treatment within past 4 weeks prior to study participation.
4. Subjects who have taken injection treatments using alcohol or phenol in upper limb within past 6 months prior to study participation.
5. Subjects with general neuromuscular synaptic disorder(e.g. Myasthenia gravis, Lambert-Eaton syndrome, Amyotrophic lateral sclerosis).
6. Subjects who have been injected with botulinum toxin within past 3 months before the injection.
7. Subjects who are pregnant or lactating of disagreed to avoid pregnancy during 3 months study period.
8. Subjects who are scheduled to take part in other clinical trial during the study period.
9. Patients who are not eligible for this study at the medical discretion of the investigator.

Primary outcomes:
measure: Comparison evaluation on improvement rate of spasticity assessed by Modified Ashworth Scale between 3 arms.
timeFrame: 4 weeks
Secondary outcomes:
measure: Comparison evaluation on improvement rate of spasticity assessed by Modified Tardieu Scale between 3 arms.
timeFrame: 4 weeks
measure: Comparison evaluation on improvement rate of range of motion on each joint between 3 arms.
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: St. Paul's Hospital, The Catholic University of Korea
name: MyungEun Chung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02177604: Can Brief High-intensity Interval Training Mitigate the Adverse Consequences of High-fat Overfeeding?
Official title: Can Brief High-intensity Interval Training Mitigate the Adverse Consequences of High-fat Overfeeding?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Insulin Resistance
Lead sponsor: University of Adelaide
Sponsor class: OTHER
Collaborators: name: Royal Adelaide Hospital
name: University of South Australia
First posted: 2014-06-27
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Previous research has shown that indulging in 50% more calories than required for as little as 3 days can significantly impact markers of metabolic health in lean and overweight individuals. Here, the investigators will determine if 3 brief sessions of high-intensity interval training can mitigate the adverse consequences of 7 days high-fat overfeeding in sedentary, overweight males.


Eligibility criteria: Inclusion Criteria:

* Sedentary (no more than 2 sessions of structured moderate intensity aerobic exercise or resistance training per week)
* Overweight (BMI 25-29.9 kg/m2)

Exclusion Criteria:

* Personal history of any major illness (i.e. cardiovascular disease, diabetes, hypertension, cancer, renal/liver impairments, major psychiatric disorders, eating disorders etc.)
* History of chest pain (either at rest or during exercise.)
* Abnormal resting ECG at screening visit
* Chronic use of any prescribed or non-prescribed medications (i.e. anti-hypertensive, statins, metformin, anti-inflammatories, antidepressants etc.)
* Blood pressure or blood lipids outside of reference ranges
* Serum ferritin \<30ng/mL
* Uncontrolled asthma, current fever, or upper respiratory infection
* Current intake of \> 140g alcohol/week
* Current smokers of cigarettes/cigars/marijuana
* Current intake of any illicit substance
* Experience claustrophobia in confined spaces
* Donated blood in the past 3 months
* Migraines
* Unable to comprehend study protocol
* Unable to perform exercise on a cycle ergometer at second screening visit

Primary outcomes:
measure: Change in glucose metabolism
timeFrame: 1 week
Secondary outcomes:
measure: Change in plasma levels of cytokines
timeFrame: 1 week
Other outcomes:
measure: Change in mitochondrial metabolism
timeFrame: 1 week
measure: Change in resting energy expenditure
timeFrame: 1 week
measure: Change in cognitive function
timeFrame: 1 week
Locations:
city: Adelaide
country: Australia
facility: South Australian Health & Medical Research Institute
state: South Australia
Study officials:
affiliation: University of Adelaide
name: Leonie Heilbronn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05553704: Metformin in Patients With Ulcerative Colitis Treated With Mesalamine
Official title: Clinical Study to Compare the Possible Efficacy of Metformin in Patients With Ulcerative Colitis Treated With Mesalamine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Inflammatory Bowel Diseases
Lead sponsor: Tanta University
Sponsor class: OTHER
Collaborators: name: Mounir Hussein Bahgat Internal Medicine Department Mansoura University
name: Maha Mohamed Maher Internal Medicine Department Mansoura University
First posted: 2022-09-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ulcerative colitis (UC) is an idiopathic, chronic inflammatory disease characterized by diffused inflammation of the colon and rectum mucosa, however, the exact underlying mechanisms of UC remain poorly understood.UC is strongly dependent on cellular immune reaction and exaggerated inflammatory response due to genetic, immune and environmental factors.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Both males and females will be included
* Negative pregnancy test and effective contraception

Exclusion Criteria:

* •

  * Breast feeding
  * Significant liver and kidney function abnormalities
  * Diabetic patients
  * Colorectal cancer patients
  * Patients with severe UC
  * Patients taking rectal or systemic steroids
  * Patients taking immunosuppressives or biological therapies
  * Addiction to alcohol and / or drugs
  * Known allergy to the studied medications

Primary outcomes:
measure: The primary endpoint is the change in partial mayo score index
timeFrame: 6 months
Secondary outcomes:
measure: The secondary endpoint is estimated by changes in serum IL-6 and TNF-alpha
timeFrame: 6 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Medicine, Mansoura University
Study officials:
References: