louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04970277: Efficacy of Drinking Water During Capsule Endoscopy
Official title: Efficacy of Drinking Water on Transit Time and Complete Examination Rate During Capsule Endoscopy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Capsule Endoscopy
Keywords: Capsule endoscopy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aims of this study are to evaluate the effect of early drinking water after the capsule ingestion on the gastrointestinal transit and image quality of capsule endoscopy.

Detailed description: Capsule endoscopy has been a significant technologic advancement that has allowed the direct examination of mucosa throughout the entire small intestine in a noninvasive fashion; and it has become the primary technique for imaging the small bowel. However, as imaging time is limited to about 8 hours, a prolonged transit of the capsule endoscope in the stomach may result in an incomplete small bowel transit (i.e. failure of the capsule to reach the cecum). Delayed transit time of stomach may be responsible for the failure of capsule endoscopy to visualize the distal portions of the small bowel, and potentially may result in the inability to identify small-bowel pathology in these areas. Previous study showed that drinking water might improve completion rate of capsule endoscopy. And bowel preparation of clear liquids may improve image quality of small bowel mucosa. The aim of this study was to assess the effect of drinking water on the transit time，completion rate and image quality of capsule endoscopy.

Eligibility criteria: Inclusion Criteria:

Patients aged 18-80 years undergoing capsule endoscopy

Exclusion Criteria:

1. Patients with suspected intestinal obstruction, intestinal diverticulum, stricture or fistula
2. previous gastric or small-bowel surgery
3. pregnancy

Primary outcomes:
measure: gastric transit time
timeFrame: 3 months
measure: small-bowel transit time
timeFrame: 3 months
Secondary outcomes:
measure: complete examination rate of the small bowel
timeFrame: 3 months
measure: image quality
timeFrame: 3 months
measure: diagnostic yields
timeFrame: 3 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Shandong University Qilu hosipital, China
name: Xiuli Zuo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04542577: PMCF Study on the Safety and Performance of PROSPACE 3D / PROSPACE 3D OBLIQUE / TSPACE 3D
Official title: Multicenter PMCF Study on the Safety and Performance of PROSPACE 3D / PROSPACE 3D OBLIQUE / TSPACE 3D - A Prospective Study on Total Indications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Instability
Spondylolisthesis
Post-discectomy Syndrome
Post-traumatic Instabilities
Keywords: Lumbar interbody Fusion
Intervertebral Implant
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
First posted: 2020-09-09
Enrollment: 208
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: All Patients undergoing PROSPACE 3D, PROSPACE 3D OBLIQUE or TSPACE 3D surgery in the participating Hospitals meeting the inclusion criteria are included in the study.

Brief summary: Prospective, pure data collection of all PROSPACE 3D, PROSPACE 3D Oblique, TSPACE 3D patients in selected centers (not interventional, multicenter

Detailed description: The study collects a data set for each patient receiving a PROSPACE 3D, PROSPACE 3D Oblique, or TSPACE 3D implant. It is intended to collect data preoperatively, intraoperatively and at one follow-up- assessment after a minimum of one year postoperatively containing

* Basic medical history
* Type of surgical procedure
* Treated segments
* Implant characteristics (including additional implants for anterior/posterior stabilization)
* Scores: ODI, Pain (VAS), EQ-5D
* Patient satisfaction

Eligibility criteria: Inclusion:

* Patient is minimum 18 years old
* Written informed consent for the documentation of clinical and radiological results
* Patient's indication according to IFU
* Patient is not pregnant

Exclusion:

- Patient is not willing or able to participate at the follow-up examination

Primary outcomes:
measure: Change of Spinal Disability measured by Oswestry Disability Index (ODI)
timeFrame: preoperatively, at 3 months postoperatively and at 12 months postoperatively
Secondary outcomes:
measure: Change of Pain (VAS)
timeFrame: preoperatively, at 3 months postoperatively and at 12 months postoperatively
measure: Change of Quality of Life (EQ-5D)
timeFrame: preoperatively, at 3 months postoperatively and at 12 months postoperatively
measure: Bone fusion
timeFrame: 12 Months postoperatively
measure: Side effects
timeFrame: up to 12 months postoperatively
Other outcomes:
Locations:
city: Koblenz
country: Germany
facility: Katholisches Klinikum Koblenz
city: Kremmen
country: Germany
facility: Sana Kliniken Sommerfeld
Study officials:
References:
Clinical trial NCT05096377: Hemi-diaphragmatic Paresis and Erector Spinae Plane Block
Official title: The Effect of Erector Spinae Plane Block on Hemidiaphragm Paresis in Shoulder Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, Regional
Shoulder
Keywords: Regional Anesthesia
Shoulder Surgery
Hemidiaphragmatic Paresis
Erector Spinae Plane Block
Lead sponsor: Antalya Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-10-27
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: PROBABILITY_SAMPLE
Study population: shoulder surgery

Brief summary: To assess the incidence of hemi-diaphragmatic paresis following ultrasound-guided erector spinae plane (ESP) block

Detailed description: The aim of the study is to assess the effect of hemi-diaphragmatic paresis following ultrasound-guided erector spinae plane block.

Eligibility criteria: Inclusion Criteria:

* 18 - 85 years
* American Society of Anesthesiology (ASA) I-III
* elective shoulder surgery

Exclusion Criteria:

* patient's refusal
* under 18 years of age or over 65 years of age
* ASA IV and above
* known allergy to local anaesthetic drugs
* the block cannot be applied due to bleeding disorders or localized skin infection at the injection site
* history of neurological and/or neuromucular disease
* history of severe bronchopulmonary disease
* a moderate to severe decrease in preoperative pulmonary function, or abnormality in preoperative chest radiography data (pleural effusion, pneumothorax, or hemidiaphragm elevation)

Primary outcomes:
measure: incidence of hemi-diaphragmatic paresis
timeFrame: 30 minutes
Secondary outcomes:
measure: intraoperative opioid consumption
timeFrame: 2 hour
Other outcomes:
Locations:
city: Muratpaşa
country: Turkey
facility: Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation
state: Antalya
Study officials:
affiliation: Antalya TRH
name: Arzu Karaveli
role: PRINCIPAL_INVESTIGATOR
affiliation: Antalya TRH
name: Ali Sait Kavaklı
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
citation: Sivashanmugam T, Maurya I, Kumar N, Karmakar MK. Ipsilateral hemidiaphragmatic paresis after a supraclavicular and costoclavicular brachial plexus block: A randomised observer blinded study. Eur J Anaesthesiol. 2019 Oct;36(10):787-795. doi: 10.1097/EJA.0000000000001069.
Clinical trial NCT02742077: Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease II
Official title: CorPath® 200 RAPID II Study (Robotic-Assisted Peripheral Intervention for Peripheral Arterial Disease)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Disease
Lead sponsor: Corindus Inc.
Sponsor class: INDUSTRY
First posted: 2016-04-18
Enrollment: 20
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 safety and performance of the CorPath 200 System in the remote delivery and manipulation of guidewires and rapid exchange catheters for use in percutaneous vascular interventions.

Detailed description: This is a prospective, single-arm, single center, non-randomized feasibility study of the CorPath 200 System to examine its performance during complete interventions (DCB, Stenting) of the femoropopliteal arteries and patient outcomes at 30 days.

Eligibility criteria: Inclusion Criteria:

General Inclusion Criteria

* At least 18 years of age;
* Symptomatic disease: presence of critical limb ischemia (including tissue loss or rest pain), or lifestyle-limiting claudication requiring intervention in the femoropopliteal arteries; and
* The subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent.

Angiographic Inclusion Criteria Femoropopliteal artery lesion(s) with stenosis (\>50%) or occlusion of up to 120 mm in length as determined by imaging (MRA or Angio) prior to index interventional procedure.

Exclusion Criteria:

General Exclusion Criteria

If any of the following criteria are met, the subject cannot be enrolled in this study:

* Failure/inability/unwillingness to provide informed consent;
* Target vessel has been previously treated with bypass; or
* Enrolled in concurrent clinical study.

Angiographic Exclusion Criteria

• Target vessel:

* Shows evidence of previous dissection or perforation, or
* Has adjacent acute thrombus; or
* Has a pre-existing target artery aneurysm or perforation or dissection of the target artery prior to initiation of the interventional procedure.

Primary outcomes:
measure: Clinical Success
timeFrame: 72 hours or hospital discharge, whichever comes first.
measure: Adverse Events
timeFrame: Procedure
Secondary outcomes:
measure: Operator Radiation Exposure Dose
timeFrame: Procedure
measure: Patient Radiation Exposure Dose
timeFrame: Procedure
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medizinische Univeristät Graz
Study officials:
affiliation: Medizinische Universtität Graz
name: Marianne Brodmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00894777: Study Evaluating Management of Patients With Moderate and Severe Psoriasis
Official title: Management of Patients With Moderate and Severe Psoriasis Under Treatment With Topical and/or Systemic Drugs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis
Keywords: Psoriasis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2009-05-07
Enrollment: 469
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with moderate and severe psoriasis under treatment with topical and/or systemic drugs in usual clinical practice

Brief summary: This is an observational, naturalistic, multicenter, retrospective study to describe the therapeutic management of patients with moderate and severe psoriasis under treatment with topical and/or systemic drugs in usual clinical practice in Spain.


Eligibility criteria: Main Inclusion Criteria:

·Over 18 years of age.·Diagnosed with moderate or severe psoriasis.·Initiated treatment with topical and/or systemic treatment between two and five years before enrollment in the study. ·Has a clinical record at the dermatologist office.

Main Exclusion Criteria:

·Currently participating in a clinical study. ·Clinical record lacks minimum data required for observational analysis.

Primary outcomes:
measure: Descriptive analysis of the therapeutic management of patients with moderate and severe psoriasis under treatment with topical and/or systemic drugs including sequence, doses and duration of treatment.
timeFrame: 4 months
Secondary outcomes:
measure: Comparison of therapeutic management depending on patients' disease severity, using absolute and relative frequencies for qualitative variables and centralization and dispersion measures (mean, SD, median, minimum, maximum..) for quantitative variables.
timeFrame: 4 months
Other outcomes:
Locations:
city: Madrid
country: Spain
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00002277: A Comparison of Fluconazole and Amphotericin B in the Treatment of Fungal Infections
Official title: Fluconazole Versus Amphotericin B: A Prospective, Randomized, Multicenter Study for Therapy of Fungal Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mycoses
HIV Infections
Keywords: Mycoses
Neoplasms
Neutropenia
Fluconazole
Amphotericin B
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To compare the safety, tolerance and efficacy of fluconazole and amphotericin B as treatment for biopsy proven fungal infections in major organs, disseminated infection, suspected fungal infection and fungemia in adult neutropenic and non-neutropenic patients without AIDS, AIDS related complex (ARC), or extensive burns. HIV seropositive patients are allowed only if they also have a malignancy.


Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Immunostimulants under studies carried out under an IRB approved protocol.
* Treatments of intercurrent non-fungal infection.
* Allowed but requires monitoring during fluconazole therapy:
* Barbiturates.
* Phenytoin.
* Oral hypoglycemics.
* Coumarin-type anticoagulants.

Patients must have the following:

* Diagnosis or presumption of fungal infection under defined conditions.
* Written informed consent either from the patient or the patient's legal guardian.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

* Burns \> 30 percent of the body.
* Diagnosis of AIDS or AIDS related complex (ARC).
* HIV positive unless they have a malignancy.
* History of allergy to or intolerance of imidazoles or azoles.
* Moderate to severe liver disease as defined by specific lab values.
* Unlikely to survive more than 24 hours.
* Evidence of previous amphotericin B sensitivity.

Concurrent Medication:

Excluded:

* Concomitant antifungal agents other than the study drugs.
* Immunostimulants, except for studies carried out under an IRB approved protocol.

Concurrent Treatment:

Excluded:

* Lymphocyte replacements.

Patients with the following are excluded:

* Defined disease conditions listed in Exclusion Co-Existing Conditions.
* Unlikely to survive more than 24 hours.
* Previous participation in this study; reentry for the same infection is not allowed.
* Known to be unable to take amphotericin B due to acute toxicities.

Prior Medication:

Excluded:

* Previous fluconazole therapy for this infection.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Dr Layne Gentry
state: Texas
city: Houston
country: United States
facility: Dr Temple Williams
state: Texas
city: Houston
country: United States
facility: M D Anderson Cancer Ctr
state: Texas
Study officials:
References:
Clinical trial NCT01934777: Efficacy and Tolerance of Treatment With DHA, Choline and Vitamin E in Children With Non-alcoholic Steatohepatitis
Official title: Study of Efficacy and Tolerance of Treatment With DHA, Choline and Vitamin E in Children With Non-alcoholic Steatohepatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Fatty Liver
Liver Fibrosis
Obesity
Metabolic Syndrome
Nonalcoholic Fatty Liver Disease
Keywords: NAFLD
NASH
fibrosis
Lead sponsor: Bambino Gesù Hospital and Research Institute
Sponsor class: OTHER
First posted: 2013-09-04
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this interventional study is to evaluate the efficacy and tolerability of docosahexaenoic acid (DHA), Vitamin E and Choline in children or adolescents with well-characterized and liver biopsy confirmed nonalcoholic fatty liver disease (NAFLD).

Detailed description: Sixty children or adolescents (4-16 years) with liver biopsy proven NAFLD will be enrolled. They will be randomized to treatment with DHA, VIT E and Choline (n=30)or an identical placebo (n=30) given orally for a period of 12 months. All patients will be included in a lifestyle intervention program consisting of a diet tailored on the individual requirements and physical exercise.

Patients will undergo a medical evaluation every three months during the 12-month study period. Liver biopsy will be performed at baseline and at 12 months. Anthropometric analysis, laboratory tests, including liver enzymes and lipids will be repeated at 3-month intervals during the 12-months study duration. Ultrasonography of the liver will be repeated after six months at the end of the study period.

Eligibility criteria: Inclusion Criteria:

* persistently elevated serum aminotransferase levels
* diffusely echogenic liver on imaging studies suggestive of fatty liver
* biopsy consistent with the diagnosis of NAFLD

Exclusion Criteria:

* hepatic virus infections (HCV RNA-PCR negative)
* Hepatitis A, B, C, D, E and G
* cytomegalovirus and Epstein-Barr virus
* alcohol consumption
* history of parenteral nutrition
* use of drugs known to induce steatosis or to affect body weight and carbohydrate metabolism
* autoimmune liver disease, metabolic liver disease, Wilson's disease, and a-1-antitrypsin-associated liver disease were ruled out using standard clinical, laboratory and histological criteria

Primary outcomes:
measure: Improvement in NAFLD Activity Score (NAS)
timeFrame: 12 months
Secondary outcomes:
measure: Improvement of serum alanine transferase levels, lipid profile, glico-insulinemic profile (all parameters of metabolic syndrome) and bright liver at ultrasonography
timeFrame: 6 and 12 months
Other outcomes:
measure: Safety
timeFrame: 6 and 12 months
Locations:
city: Rome
country: Italy
facility: Bambino Gesù Hospital and Research Institute
state: Rome, Italy
Study officials:
affiliation: Bambino Gesù Children Hospital
name: Valerio Nobili, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01430377: Side Branch Predilatation Strategy in Coronary Bifurcation Lesion Stenting (SBPS)
Official title: Side Branch Predilatation Strategy in Coronary Bifurcation Lesion Stenting (SBPS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Ostium Stenosis
Myonecrosis
Keywords: periprocedural myonecrosis
procedure time
fluoroscopy time
Lead sponsor: Medica Cor Heart Hospital
Sponsor class: OTHER
First posted: 2011-09-08
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The role of Side Branch (SB) predilatation during coronary bifurcation lesion percutaneous coronary intervention (PCI) is still not established. The predilatation could potentially damage SB ostium by vessel dissection, making subsequent wiring problematic. However, predilatation could eliminate SB ostial stenosis obviating need for further SB treatment after main vessel stent implantation. The aim of the study is to assess in random fashion the periprocedural myonecrosis, complication rates and time for SB rewiring in groups with and without SB predilatation.


Eligibility criteria: 1. Inclusion Criteria

   * Subject at least 18 years of age.
   * Subject able to verbally confirm understandings of risks, benefits of receiving PCI for true bifurcation lesions, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
   * Target main branch lesion(s) located in a native coronary artery with diameter of ≥ 2.5 mm and ≤ 4.5 mm. Target side branch lesion(s) located in a native coronary artery with diameter of ≥ 2.0 mm.
   * Target lesion(s) amenable for PCI with balloon angioplasty of the side branch.
2. Exclusion Criteria

   * ST-segment elevation myocardial infarction (STEMI)
   * Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
   * Subjects who refuse to give informed consent.
   * Subjects with left ventricle ejection fraction \<30%
   * Subjects with moderate or severe degree valvular heart disease or primary cardiomyopathy
   * Contraindications for 12 months double antiplatelet therapy

Primary outcomes:
measure: Time for rewiring SB
timeFrame: 24h
Secondary outcomes:
measure: Periprocedural myonecrosis
timeFrame: 24 h
measure: MACE
timeFrame: 12 months
Other outcomes:
Locations:
city: Ruse
country: Bulgaria
facility: Medica Cor Heart Hospital
Study officials:
References: