louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00972088: Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease
Official title: Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Disease
Perianal Fistula
Perianal Abscess
Keywords: inflammation of the small bowel
Lead sponsor: Bikkur Holim Hospital
Sponsor class: OTHER
First posted: 2009-09-04
Enrollment: 26
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To show that prevalence of inflammation of the small bowel in patients with anorectal disease is under-diagnosed based on colonoscopy ileoscopy alone.

Detailed description: IBD of the small bowel is associated with perianal disease such as ano-rectal abscesses and fistulas. Colonoscopy with ileoscopy and small bowel series are relied upon to document the presence of Crohn's disease of the small bowel. We suspect that the prevalence of inflammatory small bowel disease is underestimated.

In my practice I have cases that had negative colonoscopy ileoscopy and positive findings at capsule endoscopy. These patients are receiving therapy for Crohn's disease. It is important to prove that the prevalence is higher.

Capsule Endoscopy (CE) is the "first line tool" diagnostic procedure for the examination of the small bowel. It is performed today in more than 2,900 GI clinics in hospitals, outpatient departments and physicians' offices all over the world using the PillCam® Platform. Over 500,000 CE procedures with the Given PillCam SB have been completed to date.

Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 10 - 80
* Patients with anorectal abscess of anorectal fistula
* Patient is male or female
* Within three months prior to enrollment, patient has normal test results for at least one of the following tests:

  1. Colonoscopy with Ileoscopy, and/or
  2. Colonoscopy with small bowel series, and/or
  3. Colonoscopy with CT enterography
* Within three months prior to enrollment patient has the following lab tests: Blood count, sedimentation rate, CRP. IBD serology is optional.
* Sign informed consent

Exclusion Criteria:

* Can not sign informed consent
* Contraindications to colonoscopy ileoscopy or capsule endoscopy
* History of established IBD

Primary outcomes:
measure: Prevalence of Inflammation as Diagnosed by Capsule Endoscopy
timeFrame: up to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Assaf Harofeh Medical Center
state: Zrifin
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Bikur Cholim Hospital
Study officials:
affiliation: Bikur Cholim Hospital, Jerusalem
name: Samuel Adler, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06231888: Difference Between Pressing and Vacuum Techniques in Fabrication of Orthodontic Aligners in Cases With Crowding: A Cross-sectional Study
Official title: Difference Between Pressing and Vacuum Techniques in Fabrication of Orthodontic Aligners in Cases With Crowding: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Orthodontic Aligners
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Maxillary arch with moderate crowding.

Brief summary: This cross sectional study is aiming to compare 2 methods of clear aligner fabrication.


Eligibility criteria: Inclusion Criteria:

* Maxillary arch with crowding.
* Full permanent dentition.

Exclusion Criteria:

* Missing teeth.
* Dental restorations.

Primary outcomes:
measure: Maxillary arch dimensions
timeFrame: 6 months
Secondary outcomes:
measure: Model superimposition
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
References:
Clinical trial NCT00129688: Once-Daily Amikacin Plus Cloxacillin in Febrile Neutropenic Children
Official title: Comparison of Efficacy, Safety and Economic Outcomes Between Once-Daily Versus Twice-Daily Amikacin in Combination With Cloxacillin in Febrile Neutropenic Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neutropenia
Cancer
Fever
Keywords: febrile neutropenia
once-daily
amikacin
cloxacillin
children
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
Collaborators: name: National Research Council of Thailand
First posted: 2005-08-12
Enrollment: 166
Sex: ALL
Minimum age (years): 1
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Once-daily dose administration of aminoglycoside in adults is effective and economical. However, its value in febrile neutropenic children, especially in Thailand, is less well researched. In the area where Pseudomonas aeruginosa prevalence in febrile neutropenic children is low, the combination of cloxacillin and amikacin is an appropriate approach. This study would like to compare the efficacy and safety including cost between these two amikacin administrations (once-daily or twice-daily) in combination with cloxacillin as an empirical therapy in febrile neutropenic children.

Hypothesis: Once-daily amikacin plus cloxacillin can be used to treat febrile neutropenic children in Khon Kaen, Thailand.

Detailed description: Fever: a single oral temperature of \>/= 38.3 degrees C; or \>/= 38.0 degrees C for \>/= 1 hour.

Neutropenia: neutrophil count, \< 500/cu mm or \<1,000/cu mm with a predicted decrease to \<500/mm3.

Eligibility criteria: Inclusion Criteria:

* Aged 1 year - 14 years
* A single oral temperature of \>/= 38.3 degrees C; or \>/= 38.0 degrees C for \>/= 1 hour.
* Neutropenia: neutrophil count, \< 500/cu mm or \<1,000/cu mm with a predicted decrease to \<500/mm3.
* During the course of chemotherapy

Exclusion Criteria:

* History of amikacin or cloxacillin allergy
* Creatinine clearance \< 30 ml/min/m2
* Central nervous system infection: meningitis or brain abscess
* History of hearing abnormality
* Severely ill: shock
* Chronic liver diseases or SGPT \> 10 times of upper normal limit
* Received aminoglycoside within 14 days prior to enrolment
* Received any intravenous antibiotics within 7 days
* Cancer which is newly diagnosed or relapsed

Primary outcomes:
measure: Afebrile within 5 days of the initial treatment regimen
measure: Nephrotoxicity and ototoxicity
Secondary outcomes:
measure: Cost difference
measure: Pharmacokinetic parameters of amikacin in these children
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Medicine, Khon Kaen University
name: Pope - Kosalaraksa, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03243578: Relationship Between Dietary Protein Intake and Fatal and Non-fatal Health Outcomes
Official title: Relationship Between Dietary Protein Intake and Fatal and Non-fatal Health Outcomes in 180,031 UK Biobank Participants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Cancer
All-cause Mortality
Lead sponsor: University of Glasgow
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 502628
Sex: ALL
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Recruitment from the general population

Brief summary: The aim of the current study was to clarify the relationship between protein intake and health by using a very large, general population cohort study, UK Biobank, to study the associations between reported protein intake (expressed in g/day, g/kg/day and % of total energy intake) and three health outcomes (all-cause mortality, incidence CVD and cancer).


Eligibility criteria: Inclusion Criteria:

* None

Exclusion Criteria:

* None

Primary outcomes:
measure: All-cause mortality
timeFrame: Mean of 7 years
measure: CVD incidence
timeFrame: Mean of 6.1 years
measure: cancer incidence
timeFrame: Mean of 6.1 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00518778: Fusariosis in Solid-Organ Transplant Recipients
Official title: Fusariosis in Solid-Organ Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Solid Organ Transplant
Fusariosis
Keywords: fusariosis
solid organ transplants
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2007-08-21
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Solid organ transplant patients diagnosed with fusariosis

Brief summary: This exempt chart review study will try to determine the clinical presentation, prognostic factors, response to different treatment modalities and mortality among patients diagnosed with fusariosis after solid-organ transplantation.

Detailed description: This exempt chart review study will try to determine the clinical presentation, prognostic factors, response to different treatment modalities and mortality among patients diagnosed with fusariosis after solid-organ transplantation.This will help determine prognostic factors, response to different treatment modalities and mortality among patients diagnosed with fusariosis after solid-organ transplantation.

Eligibility criteria: Inclusion Criteria:

* Solid-organ transplants (liver, kidney, lung, heart, pancreas, small bowel transplant) diagnosed with fusariosis or infections due to Fusarium, species in our institution

Exclusion Criteria:

* Those subjects that do not meet inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Adarsh Bhimraj, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03416478: The Implication of ctDNA in the Recurrence Surveillance of Stage II and III Colorectal Cancer
Official title: The Implication of Plasma Circulating Tumor DNA (ctDNA) in the Recurrence Surveillance of Stage II and III Colorectal Cancer: a Prospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
ctDNA
Surveillance
Keywords: Colorectal Cancer
ctDNA
Surveillance
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-01-31
Enrollment: 50
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 stage II or stage III colorectal cancer must have baseline evaluations performed prior to the study and must meet all inclusion and exclusion criteria.

Brief summary: This study is to evaluate circulating tumor DNA (ctDNA) as a predictive and surveillant method for tumor recurrence in stage II and III colorectal cancer (CRC).

Detailed description: This study will evaluate circulating tumor DNA (ctDNA) as a prognostic marker and as a monitor of a short-term disease recurrence in surgical resective stage II and stage III colorectal cancer (CRC). The investigators will recruit newly diagnosed CRC patients, systematically collect their blood samples at the following time point: before surgery, one week after surgery, every three months for the first year and every six months for the second year, which are coincidence with the recommended clinical follow-up. Patients' outcome and survival will be tracked. These study will permit assessment of ctDNA as a predictive and surveillant method for a short-term (two years) tumor recurrence in comparison with other parameters.

Eligibility criteria: Inclusion Criteria:

* Male or female ≥ 18 years of age on the day of signing informed consent.
* Patients must have histologically confirmed stage II or IIIcolorectal cancer.
* Patients must receive radical resection.
* Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study.

Exclusion Criteria:

* Patient has severe anemia.
* Patients received neoadjuvant treatment.
* Patients received blood transfusion two weeks before or during the surgical resection.
* Patient has any other conditions, which, in the opinion of the Investigator, would interfere with the evaluation of the subject

Primary outcomes:
measure: Disease Free Survival
timeFrame: Two years
Secondary outcomes:
measure: Overall survival
timeFrame: Two years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: the Sixth Affiliated Hospital, Sun Yet-sen University
Study officials:
affiliation: Sixth Affiliated Hospital, Sun Yet-sen University
name: Xiaojian Wu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03571178: Quantitative Ultrasound of Trapezius Muscle in Cervical Myofascial Syndrome
Official title: Quantitative Ultrasound of Trapezius Muscle in Cervical Myofascial Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myofascial Pain Syndrome
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2018-06-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The myofascial points within the trapezius muscle are hypoechogenic regions that can be depicted via ultrasound imaging. In this study we aimed to demonstrate the hypoechogenic regions within the trapezius muscle and to determine if physical therapy modalities change the appearance and size of these areas. We also wanted to explore if the presence of these areas correlate with pain.


Eligibility criteria: Inclusion Criteria:

* Patients with myofascial pain syndrome in the cervical region

Exclusion Criteria:

* Presence of cervical radiculopathies
* Previous history of cervical injusy
* Presence of rheumatologic diseases

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Ozge Kenis Coskun
state: Kadikoy
Study officials:
References:
citation: Sancar M, Kenis-Coskun O, Gunduz OH, Kumbhare D. Quantitative Ultrasound Texture Feature Changes With Conservative Treatment of the Trapezius Muscle in Female Patients With Myofascial Pain Syndrome. Am J Phys Med Rehabil. 2021 Nov 1;100(11):1054-1061. doi: 10.1097/PHM.0000000000001697.
Clinical trial NCT03603132: A Study to Evaluate Different Intervals Between Dosing and Feeding on the Pharmacokinetics
Official title: Effects of Different Dosing and Feeding Intervals on the Pharmacokinetic Parameters of Herombopag Olamine Tablets
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Immune Thrombocytopenia
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-07-27
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study use a single-center, randomized, open, three-cycle, self-control trial design. It is planning to enroll 15 healthy adult male subjects. Fifteen subjects will randomize into 3 test groups which corresponding to 3 different dosing sequences. Subjects will be giving a single oral dose in per cycle, and there will have three types of breakfast administration after each treatment. Washing period is 10 days during the cycle.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old
2. The subject's body weight was ≥ 50.0 kg, BMI was between 19 and 26 kg/m2
3. Signed informed consent.

Exclusion Criteria:

1. Any clinically serious disease that has or is currently suffering from circulatory, endocrine, nervous, digestive, respiratory, hematological, immunological, psychiatric, and metabolic abnormalities, or any other disease that can interfere with the test results
2. Having deep vein thrombosis or other thrombotic diseases.
3. Having thrombocytopenia, mitral valve prolapse, obvious heart murmur, or murmur.
4. Extended QT interval during the screening period (calculated in Bazett's method, males \>450 msec)
5. Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody positive.
6. Those who have a history of allergies to drugs , food or test drugs or similar drugs;
7. Those who have undergone surgery within 4 weeks prior to the trial or plan to perform surgery during the study
8. Those who took any drug within 14 days before the test (including Chinese herbal medicine)
9. Any drug that inhibits or induces liver drug metabolism within 30 days before the test
10. Subjects have participated in other clinical trial within the 3 months prior to study entry.
11. One or more non-pharmacological contraceptive measures cannot be used during the trial, or it is planned to have birth within six months.

Primary outcomes:
measure: Adverse events
timeFrame: from baseline up to Day 26
Secondary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: pre-dose ,0.5 h、 1 h、 2 h、 4 h、 6 h、 7 h、 8 h、 10 h、 12 h、 24 h、 48 h、 72 h、 96 h、 120 h after giving dose in each group
measure: Area under the plasma concentration versus time curve (AUC)
timeFrame: pre-dose ,0.5 h、 1 h、 2 h、 4 h、 6 h、 7 h、 8 h、 10 h、 12 h、 24 h、 48 h、 72 h、 96 h、 120 h after giving dose in each group
Other outcomes:
Locations:
city: Changsha
country: China
facility: The third xiangya hospital Hospital,of central south university
state: Hunan
Study officials:
References:
Clinical trial NCT06444932: SUPPLEMENTARY EFFECTS OF RESISTANCE TRAINING IN ADDITION TO JOINT MOBILIZATION IN PERSONS WITH KNEE OSTEOARTHRITIS
Official title: SUPPLEMENTARY EFFECTS OF RESISTANCE TRAINING IN ADDITION TO JOINT MOBILIZATION IN PERSONS WITH KNEE OSTEOARTHRITIS
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 44
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double arm parallel design RCT
Primary purpose: TREATMENT

Brief summary: Joint mobilization and resistance exercise training are effective conservative treatment options for the management of osteoarthritis. However, currently no study has highlighted the supplementary effects of resistance training in addition to joint mobilization in people suffering from knee osteoarthritis. The current study is aimed at bridging the gap in literature and providing evidence regarding the additive impact of resistance training to joint mobilization in knee osteoarthritis.


Eligibility criteria: Inclusion Criteria:

* Knee OA grade I-III
* Individuals of either gender aged 40-70 years
* Knee OA history of no less than 3 months
* Knee pain no more than 8/10 cm on the visual analogue scale (VAS)
* Radiological evidence of grade III or less on Kellgren classification.

Exclusion Criteria:

* Those with signs of serious pathology such as malignancy, inflammatory disorder or infection.
* History of trauma or fractures in lower extremity
* Signs of lumbar radiculopathy or myelopathy
* History of knee surgery or replacement and/or receiving intra-articular steroid therapy in the preceding two months

Primary outcomes:
measure: Walking related performance fatigability
timeFrame: 4 weeks
measure: Stride Length
timeFrame: 4 weeks
measure: Gait velocity
timeFrame: 4 weeks
measure: Knee Pain
timeFrame: 4 weeks
measure: Knee range of motion
timeFrame: 4 weeks
measure: Functional Disability
timeFrame: 4 weeks
measure: Isometric Muscle Strength
timeFrame: 4 weeks
measure: Functional capacity
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation Univeristy Islamabad
Study officials:
affiliation: Foundation University Islamabad
name: Wania Maheen, DPT
role: PRINCIPAL_INVESTIGATOR
affiliation: Foundation University Islamabad
name: Muhammad Osama, PhD*
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01300832: The Incidence of Perioperative Deep Venous Thromboses of the Lower Extremities
Official title: The Incidence of Perioperative Deep Venous Thromboses of the Lower Extremities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perioperative DVTs
Keywords: Surgery
Deep Vein Thrombosis
Preoperative
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2011-02-23
Enrollment: 271
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The study's hypothesis is that there are some patients who come for surgery who have asymptomatic clots in their lower extremities upon their arrival to the hospital for their surgical admission. We will be performing duplex studies of the subjects' legs before their surgery to determine how often clots are present. We will also perform duplex scans of the legs after the subjects' surgeries to determine what factors (surgical, anesthetic, co-morbidities)are correlated with the development of DVTs.


Eligibility criteria: Inclusion Criteria:

* Age 18+ and consentable

Exclusion Criteria:

* Anticoagulation therapy or known DVT

Primary outcomes:
measure: The incidence of preoperative DVTs
timeFrame: Day of surgery
measure: Incidence of post-operative DVTs
timeFrame: Within 48 hours of surgery
Secondary outcomes:
measure: Risk factors associated with the development of perioperative DVTs
timeFrame: Within 180 days of surgery
measure: Distribution and laterality
timeFrame: Within 180 days of surgery
measure: Risks associated with perioperative DVTs
timeFrame: Within 180 days of surgery
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Hospitals
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago, Department of Anesthesiology
name: David Glick, MD
role: PRINCIPAL_INVESTIGATOR
References: