louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00543556: MK0767 in Type 2 Diabetes (0767-012)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-15
Enrollment: 514
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a clinical trial in patients with Type 2 Diabetes to test the safety of MK0767. This study will also see how effective MK0767 is in lowering markers of glucose metabolism and improving the lipid profile and non-HDL cholesterol when compared with placebo and pioglitazone.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes Mellitus patients between the ages of 21 and 75 inclusive
* Patient is willing to discontinue current therapy for the duration of the study
* Patient is not a heavy drinker

Exclusion Criteria:

* Patient has a history of Type 1 diabetes and/or ketoacidosis
* Patient has severe diabetic retinopathy, or nephropathy, or neuropath
* Patient has has anti-hyperglycemic therapy including insulin, or rosiglitazone and pioglitazone or 2 or more oral agents in combination within 8 weeks prior to visit 1
* Patient has a history of, allergy to, intolerance or hypersensitive to troglitazone, rosiglitazone, or pioglitazone including history of elevated liver function test, jaundice, or hepatotoxicity associated with these treatments

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03668756: Comparison of Computer-Assisted Navigation and Conventional Instrumentation for Bilateral Total Knee Arthroplasty
Official title: Comparison of Computer-Assisted Navigation and Conventional Instrumentation for Bilateral Total Knee Arthroplasty: The Functional Outcome of Mid-Term Follow-up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthropathy of Knee Joint
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 56
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who were scheduled to undergo staged bilateral TKA and randomly assigned to receive CAS TKA in one limb and conventional TKA in the other at the 8-year follow-up.

Brief summary: To compare the functional outcomes of Computer-Assisted Navigation (CAS) and Conventional Instrumentation TKA at the 8-year follow-up.

Detailed description: The data of the present study was collected from the review of the medical chart of the patients who were scheduled to undergo staged bilateral TKA and randomly assigned to receive Computer-Assisted Navigation (CAS) TKA in one limb and conventional TKA. Then, comparing the functional outcomes of CAS and Conventional Instrumentation was performed by statistical software.

Eligibility criteria: Inclusion Criteria:

* The patients who were scheduled to undergo staged bilateral TKA and randomly assigned to receive CAS TKA in one limb and conventional TKA in the other at the 8-year follow-up.

Exclusion Criteria:

-

Primary outcomes:
measure: International Knee Society (IKS)
timeFrame: up to 8-year follow-up
Secondary outcomes:
measure: Radiographic evaluation
timeFrame: Baseline and 3 months after operation
measure: Hospital for Special Surgery (HSS) Questionnaire
timeFrame: Baseline, 8-year follow-up
measure: Western Ontario and McMaster University Osteoarthritis Index (WOMAC)
timeFrame: Baseline, 8-year follow-up
measure: Short Form-36 (SF-36) Health Survey
timeFrame: Baseline, 8-year follow-up
Other outcomes:
Locations:
city: Pizi
country: Taiwan
facility: Sports Medicine Center, Chang Gung Memorial Hospital
Study officials:
affiliation: Sports Medicine Center, Chang Gung Memorial Hospital, Chiayi
name: Robert Wen-Wei HSU, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00347256: Chemoradiotherapy Followed by Surgery for Advanced Paranasal Sinus Cancer
Official title: Preoperative Radiotherapy and Concomitant Chemotherapy Followed by Surgery for Advanced Paranasal Sinus Carcinoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Paranasal Sinus Neoplasms
Lead sponsor: University of Tennessee
Sponsor class: OTHER
Collaborators: name: North American Skull Base Society
First posted: 2006-07-04
Enrollment: 60
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: The purpose of this study is to determine the efficacy of concurrent chemotherapy and radiotherapy pre-operatively in patients with advanced paranasal sinus cancer. The main objectives of this study are: 1) to measure the rate of complete response to preoperative chemoradiation and 2) to study the efficacy of combining preoperative chemoradiation and surgery in terms of local control of the cancer two years post treatment.


Eligibility criteria: Inclusion Criteria:

* Karnofsky Performance Score: \>= 60
* Creatinin clearance \>= 50 ml/min or serum creatinine =\<1.5 mg/dl
* Total bilirubin, AST, ALT =\< 1.5 X laboratory uln
* ANC \>= 2000/mm3, platelets \>= 100,000/mm3
* Serum calcium within normal range
* T3 or T4 state tumors of paranasal sinuses
* Squamous cell carcinoma, adenocarcinoma, high-grade mucoepidermoid carcinoma, sinonasal undifferentiated carcinoma

Exclusion Criteria:

* History of other malignancy in the last 3 years
* Other serious comorbidity that may significantly reduce the survival in next 5 years
* Pregnant or lactating women
* History of radiation to the head and neck region
* Paranasal sinus tumor is recurrent after prior treatment
* Presence of cervical node metastasis
* Presence of distant metastasis
* Advanced nasopharyngeal malignancy with sphenoid or posterior ethmoid invasion

Primary outcomes:
measure: Local control of cancer at two years post treatment
measure: Response to preoperative chemoradiation
Secondary outcomes:
measure: Estimation of the proportion of the inoperable tumors which become operable after chemoradiation
measure: Identification of factors that are associated with inoperability
measure: Estimation of the overall survival and cumulative incidence of death due to disease at 2 years
measure: Determination of the acute and long-term toxicity, particularly ophthalmologic complications, and surgical morbidity associated with this regimen
measure: Measurement of the accuracy of conventional imaging techniques (CT, MRI) compared with the addition of PET imaging in predicting the response to chemoradiation therapy.
Other outcomes:
Locations:
Study officials:
affiliation: University of Tennessee
name: Sandeep Samant, MS, FRCS
role: STUDY_CHAIR
affiliation: University of Tennessee
name: Sandeep Samant, MS, FRCS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00638456: Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis
Official title: Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis, a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Eosinophilic Esophagitis
Keywords: Eosinophils
Esophagitis
Microscopy
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Meritage Pharma, Inc.
First posted: 2008-03-19
Enrollment: 32
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to evaluate whether or not oral viscous budesonide is effective in treating children with Eosinophilic Esophagitis.


Eligibility criteria: Inclusion Criteria:

* Histologic evidence of EE defined as greater than 20 eosinophils per hpf on esophageal biopsy
* Ages 1 yrs and older
* Ability to continue the same diet that the patient was on at the time of EGD with biopsy

Exclusion Criteria:

* Adverse reaction or allergy to budesonide
* Pregnancy
* Chronic diseases requiring immunomodulatory therapy
* Use of swallowed topical corticosteroids for EE within the past 3 months
* Use of systemic steroids 2 months prior to study entry
* Upper gastrointestinal bleed within 4 months of study entry
* Chronic use of medications that predispose to upper gastrointestinal bleeding including non-steroidal anti-inflammatory medications or anticoagulants
* Evidence of adrenal suppression prior to study entry
* Evidence of concurrent eosinophilic gastritis, enteritis, colitis, or proctitis
* Recent changes in asthma or allergic rhinitis therapy for 3 months

Primary outcomes:
measure: Number of Participants With Improvement of Espohageal Eosinophilia
timeFrame: 3 Months
Secondary outcomes:
measure: Upper Gastrointestinal Endoscopy Score
timeFrame: Baseline and 3 Months
measure: Symptom Score
timeFrame: Baseline and 3 Months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Rady Children's Hospital, San Diego
state: California
Study officials:
affiliation: UCSD
name: Ranjan Dohil, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dohil R, Newbury R, Fox L, Bastian J, Aceves S. Oral viscous budesonide is effective in children with eosinophilic esophagitis in a randomized, placebo-controlled trial. Gastroenterology. 2010 Aug;139(2):418-29. doi: 10.1053/j.gastro.2010.05.001. Epub 2010 May 7.
Clinical trial NCT02891356: Bone Mass Changes in Anorexia Nervosa Patient Followed During 4 Years
Official title: Bone Mass Changes in Anorexia Nervosa Patient Followed During 4 Years and Relationship Between Bone Loss and Adipokines.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anorexia Nervosa
Osteoporosis
Keywords: Adiponectin
Bone remodelling markers
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anorexia patient recruted in psychiatric unit ( hospitalisation and consultation visit)

Brief summary: The mechanism of bone loss in anorexia nervosa is complex. Marrow adipose tissue seems to play a role in the regulation of bone metabolism. Adipocytes secrete cytokines and adipokines that either stimulate or inhibit adjacent osteoblasts. This study consist to explore the relationship in anorexia nervosa patients with change in bone mineral density and adipokines like leptin, adiponectin and Préf-1 Bone mineral densities will be measure in 180 anorexia nervosa patients at inclusion and every two years during 6 years.It is assessed blood and urinary calcium and phosphate levels, bone remodelling markers and adipokines (leptin, adiponectin and Préf-1)


Eligibility criteria: Inclusion Criteria:

* anorexia patient defined by DSM IV diagnostic criteria

Exclusion Criteria:

* patient with other psychiatric disease
* patient with other a metabolic bone disease

Primary outcomes:
measure: Bone mineral density by Dual Energy X-ray Absorptiometry (DEXA)
timeFrame: 4 years
Secondary outcomes:
measure: Incidence of osteoporotic fractures
timeFrame: at 2,4 and 6 years
measure: Adiponectin plasma concentration by ELISA
timeFrame: at 2,4 and 6 years
measure: Interleukin-7 plasma concentration by ELISA
timeFrame: at 2,4 and 6 years
Other outcomes:
Locations:
city: Lille
country: France
facility: Hôpital Roger Salengro, CHRU de Lille
Study officials:
affiliation: University Hospital, Lille
name: Isabelle LEGROUX, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05328856: Effects of Vital Shower on Quality of Life, Immune Function, Cardiovascular Regulation and Well-being
Official title: An Randomised Controlled Trial on the Effects of Vital Shower (Hansgrohe) on Quality of Life, Immune Function, Cardiovascular Regulation and Well-being
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: General Population
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this exploratory randomized controlled clinical study is to evaluate the health-promoting effects of Kneipp hydrotherapy, in the form of the Vital Shower in a four-week daily application.


Eligibility criteria: Inclusion Criteria:

* Female and male patients between 18 and 70 years of age

Exclusion Criteria:

* Bad general condition
* Serious acute or chronic comorbidity
* Pregnancy and breast feeding period/ in the next 6 months
* Participation in a clinical trial within the last 3 months before enrollment
* Simultaneous participation in another clinical trial
* Raynaud's disease or cold agglutinin disease
* Severe mental illness
* Insufficiently treated dermatological diseases (e.g. neurodermatitis, psoriasis)
* Non-compatible sanitary shower or bath devices

Primary outcomes:
measure: Immunological laboratory
timeFrame: Change from Baseline and after 4 weeks
measure: Blood pressure at rest (systolic and diastolic)
timeFrame: Change from Baseline and after 4 weeks
measure: Hospital Anxiety and Depression Scale (HADS-D)
timeFrame: Change from HADS-D Baseline, after 4 weeks and 12 weeks
measure: Self-Efficacy Scale (ASKU)
timeFrame: Change from ASKU Baseline, after 4 weeks and 12 weeks
measure: WHO-Five Well-Being Index (WHO-5)
timeFrame: Change from WHO-5 Baseline, after 4 weeks and 12 weeks
measure: Perceived Stress Scale (PSS-10)
timeFrame: Change from PSS-10 Baseline, after 4 weeks and 12 weeks
measure: Flourishing Scale (FS-D)
timeFrame: Change from FS-D Baseline, after 4 weeks and 12 weeks
measure: Insomnia Severity Index (ISI-D)
timeFrame: Change from ISI-D Baseline, after 4 weeks and 12 weeks
measure: Short Form (SF-36)
timeFrame: Change from SF-36 Baseline, after 4 weeks and 12 weeks
measure: Von Zerssen somatic complaint list (B-LR and B-LR')
timeFrame: Change from B-LR and B-LR' Baseline, after 4 weeks and 12 weeks
measure: Heart rate variability
timeFrame: Change from Baseline and after 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Hochschulambulanz für Naturheilkunde am Immanuel Krankenhaus
Study officials:
References:
Clinical trial NCT01076309: Corneal Endothelium Cell Loss After Cataract Extraction in Patients Taking Tamsulosin
Official title: Corneal Endothelium Cell Loss After Cataract Extraction in Patients Taking Systemic Sympathetic Alfa-1-a-antagonist Medication (Tamsulosin)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: cataract surgery
tamsulosin
endothelium cell
Lead sponsor: Frederiksberg University Hospital
Sponsor class: OTHER
First posted: 2010-02-26
Enrollment: 60
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for catarct surgery.

Brief summary: The purpose of this study is to determine whether corneal endothelium cell loss during cataract surgery is higher in patients taking Tamsulosin.

Detailed description: Cataract surgery in patients taking Tamsulosin is regarded as more challenging for the surgeon because Intraoperative Floppy Iris Syndrome (IFIS) might occur. However, the question is whether this has any practical implication for the outcomes of surgery. In this study we investigate whether cornea is damage during surgery on Tamsulosin patient. In an observational study 30 cataract patients taking Tamsulosin is compared to 30 patients not taking Tamsulosin, but otherwise similar. Number of patients is based on power calculation.

Cornea is examined by specular microscopy.

Eligibility criteria: Inclusion Criteria:

* cataract needing surgery

Exclusion Criteria:

* glaucoma
* corneal scarring
* diabetes
* uveitis

Primary outcomes:
measure: corneal endothelium cell loss
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Frederiksberg University Hospital
Study officials:
References:
Clinical trial NCT04403256: Bone-biomarkers of Spinal Cord Injury Patients
Official title: Changes of Bone-biomarker According to the Severity of Spinal Cord Injury.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injuries
Bone Resorption
Osteoporosis
Keywords: Sclerostin
osteoporosis
Spinal cord injury
Unloading
Lead sponsor: Yeungnam University Hospital
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with spinal cord injury difficult to walk

Brief summary: Patients with spinal cord injury have a high prevalence of osteoporosis due to chronic skeletal unloading. Recently, various treatment drugs for osteoporosis have been developed. In particular, romosozumab, a sclerostin inhibitor, has been reported to have a high therapeutic effect as an inhibitor of bone resorption while promoting bone formation. However, there are a few research concerning sclerostin of spinal cord injuries patients. Therefore we want to analyze the change of sclerostin as well as factors indicating bone formation and absorption marker in spinal cord injury patient.


Eligibility criteria: Inclusion Criteria:

* spinal cord injury patients
* Functional ambulatory category index of 3 or less

Exclusion Criteria:

* history of using bone absorption medication within the effective period

Primary outcomes:
measure: Serum sclerostin level
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
Study officials:
References:
Clinical trial NCT04845009: Relaxation Therapy for Pain, Fatigue and Vital Signs in Post-operation With Head and Neck Cancer
Official title: The Effectiveness of Progressive Muscle Relaxation on Postoperative Pain, Fatigue, and Vital Signs in Patients With Head and Neck Cancers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Progressive Muscle Relaxation on Postoperative Pain, Fatigue, and Vital Signs in Patients With Head and Neck Cancers
Keywords: progressive muscle relaxation
head and neck cancer
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2021-04-14
Enrollment: 67
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to investigate the effects of progressive muscle relaxation (PMR) on postoperative pain, fatigue, and vital signs in patients with head and neck cancers.


Eligibility criteria: Inclusion Criteria:

- Head and neck cancer, need for surgery.

(1) clear consciousness; (2) \>= 20 years; (3) no history of surgery for head and neck cancer, regardless of cancer staging, tracheostomy tubing, degree of primary tumor resection, neck dissection, modified radical neck dissection, resection of cervical nerve root branches, and flap reconstruction (including free flap and transposition flap); (4) plan to undergo surgery; (5) willingness to participate in this study and provide informed consent; (6) physically capable of participation the study, as determined by the physician in charge; (7) ability to communicate in Mandarin or Taiwanese, with no reading, listening, or writing disability, and complete the questionnaire alone or with the assistance of the researchers.

Exclusion Criteria:

- Head and neck cancer, not for surgery.

(1) use of hypnotics or record of a sleep disorder within 3 months prior to admission; (2) difficulty hearing, external auditory canal trauma, or hearing impairment; (3) diagnosis of a psychotic disorder or cognitive impairment; (4) experience practicing Jacobson's PMR.

Primary outcomes:
measure: Pain level change
timeFrame: preoperative day to postoperative day 10
measure: muscle tightness level change
timeFrame: preoperative day to postoperative day 10
measure: Fatigue levels change
timeFrame: preoperative day to postoperative day 10
Secondary outcomes:
measure: Heart rate change
timeFrame: preoperative day to postoperative day 10
measure: Systolic blood pressure change
timeFrame: preoperative day to postoperative day 10
measure: Diastolic blood pressure change
timeFrame: preoperative day to postoperative day 10
measure: Anxiety level
timeFrame: preoperative day to postoperative day 10
measure: depression level
timeFrame: preoperative day to postoperative day 10
measure: sleep disturbance level
timeFrame: preoperative day to postoperative day 10
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01962909: Phase 0 Biodistribution of Novel Imaging for Resectable Pancreatic Cancer
Official title: A Phase 0, Open Label Study to Evaluate the Biodistribution and Pharmacokinetics of a Single Intravenous Bolus Dose of PTP-01 in Subjects With Resectable Pancreatic Ductal Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Pancreatic Ductal Adenocarcinoma
Keywords: Pancreatic Resection
Lead sponsor: University of Virginia
Sponsor class: OTHER
First posted: 2013-10-14
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this clinical trial is to study an experimental drug called PTP-01 that is being used as an imaging agent to diagnosis pancreatic cancer. Currently, pancreatic cancer is diagnosed using CT or MRI scans which miss small pancreatic cancers, particularly early stage disease. Researchers at the University of Virginia have identified a biomarker for pancreatic cancer called plectin, which is very specific for pancreatic cancer and not other, non-cancerous conditions involving the pancreas. These researchers have also developed PTP-01, an experimental drug that may be used with SPECT imaging to detect pancreatic cancer cells in humans.


Eligibility criteria: Inclusion Criteria:

* subject is undergoing resection of pancreas for pancreatic ductal adenocarcinoma (PDAC)
* subject must have adequate renal function
* ECOG performance status of 0-2
* women of child-bearing age and men must agree to use contraception prior to and during the study

Exclusion Criteria:

* subjects receiving any other investigational agents
* significant history of uncontrolled cardiac disease or central nervous system (CNS) disease
* pregnant or breastfeeding women

Primary outcomes:
measure: Ability of PTP-01 to detect pancreatic ductal adenocarcinoma
timeFrame: up to 72 hours post dose
Secondary outcomes:
measure: Biodistribution and Binding Characteristics of PTP-01
timeFrame: up to 7 days post dose
measure: Clearance of PTP-01
timeFrame: up to 7 days post dose
measure: Safety and Tolerability of PTP-01
timeFrame: up to 30 days post dose
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Reid Adams, MD
role: PRINCIPAL_INVESTIGATOR
References: