louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00734812: Laparoscopic Supracervical Hysterectomy Versus Total Laparoscopic Hysterectomy
Official title: LSH vs. TLH, A Randomized Single Blind Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Gynecologic Diseases
Keywords: Hysterectomy
Laparoscopic
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2008-08-14
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to evaluate whether there is any difference in recovery time and return to normal activities following a laparoscopic supracervical hysterectomy (LSH) compared with total laparoscopic hysterectomy (TLH). Both types of hysterectomies are commonly performed at our institution.

Patients will be assigned by chance (like a coin toss) to have either a LSH or a TLH. Preoperatively, participants will complete a quality of life questionnaire (SF-36), a sexual function questionnaire (FSFI)and a 3 question questionnaire about urinary function (3IQ).

Following surgery participants will be asked to keep a diary of pain symptoms and use of narcotics. The diary will be filled out daily until patients have resumed normal activities from prior to the surgery. The SF-36 will be completed again 6 weeks following the original surgery.

6 months following surgery participants will receive a copy of the SF-36 and the FSFI in the mail. They will also be asked questions about urinary symptoms and persistent vaginal bleeding.


Eligibility criteria: Inclusion Criteria:

* Candidates for laparoscopic hysterectomy for benign indications

Exclusion Criteria:

* Malignancy of the uterus, cervix or adnexa
* pre-malignant changes of the uterus, cervix or adnexa
* history of severe cervical dysplasia (CIN II or above)

Primary outcomes:
measure: Return to normal activities
timeFrame: 3-6 weeks after surgery
Secondary outcomes:
measure: Sexual function
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Jon I. Einarsson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04474912: Serum IL-17 Correlated With Inflammatory Changes in Osteoarthritis and Rheumatoid Arthritis
Official title: Serum IL-17 Correlated With Inflammatory Changes But Not With Bony Changes in Both Hand Osteoarthritis and Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis (RA) and Osteoarthritis (OA)
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-07-17
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study participants will be recruited from attendants to Rheumatology and Rehabilitation outpatient clinic at Zagazig University Hospitals

Brief summary: The total number of the included subjects was 120 in 3 equal groups (RA, OA and control). All subject was subjected to serum IL17 level measurement. MSK US (of both wrists, MCPs, PIPs and DIPs) was done to all patients in RA and OA groups. Disease activity was measured by disease activity score (DAS28) for RA patients. Visual analogue scale for pain (VAS) was obtained from patients in RA and OA groups. Functional assessment was done using health assessment questionnaire (HAQ) for RA patients and the Australian/Canadian (AUSCAN) Osteoarthritis Hand Index for OA patients


Eligibility criteria: Inclusion Criteria:

* A patient is considered having definite RA if he/she scores at least 6 points in the established classification system
* A patient is considered having Hand OA if he /she Hand pain, aching, or stiffness plus 3 or 4 of hard tissue enlargement of 2 or more of 10 selected joints or hard tissue enlargement of 2 or more DIP joints or fewer than 3 swollen MCP joints, or deformity of at least 1 of 10 selected joints which are are the second and third distal interphalangeal (DIP), the second and third proximal interphalangeal, and the first carpometacarpal joints of both hands

Exclusion Criteria:

* Any subject with liver diseases, coronary artery diseases, kidney diseases or other inflammatory conditions was excluded from the study.

Primary outcomes:
measure: Clinical disease activity in Rheumatoid Arthritis (RA) and hand Osteoarthritis (OA) patients
timeFrame: 12 months
Secondary outcomes:
measure: IL-17 serum levels in RA and OA patients
timeFrame: 2 weeks
Other outcomes:
measure: Radiologic bony changes in RA and OA patients
timeFrame: 12 months
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Faculty of Medicine
state: Sharqia
Study officials:
References:
Clinical trial NCT03880812: Cost Information on Carpal Tunnel Syndrome Treatment Decisions
Official title: Does Societal Cost Information Affect Patient Decision-Making in Carpal Tunnel Syndrome: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
Collaborators: name: Stanford University
First posted: 2019-03-19
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were randomized in an intervention group that reviewed societal costs associated with carpal tunnel release and a control group that did not.
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine whether the provision of societal cost information affects patients' decisions whether or not to undergo surgical management in carpal tunnel syndrome, using a hypothetical scenario.

Detailed description: Given the large societal costs of carpal tunnel surgery and existence of a relatively inexpensive treatment option, carpal tunnel release provides fertile ground for testing whether societal costs can influence patient decision-making in hand surgery. Such work would inform future efforts to reduce societal healthcare costs by elucidating whether appeals to societal cost are effective at driving stewardship of limited healthcare resources at the patient level. In this study, the investigators aimed to answer this question by presenting participants with a hypothetical scenario in which the participants had to choose between surgery and wrist bracing for carpal tunnel syndrome. Participants were randomized into two cohorts and societal cost information was presented to the intervention group. The effect of societal cost information on treatment choice is assessed, along with participants' healthcare attitudes.

Eligibility criteria: Inclusion Criteria:

* English speaking upper extremity patients
* Nontraumatic condition

Exclusion Criteria:

* Traumatic condition

Primary outcomes:
measure: Number of participants choosing carpal tunnel release or splinting
timeFrame: Immediately after reading the hypothetical scenario
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Austin Regional Clinic
state: Texas
city: Austin
country: United States
facility: Texas Orthopedics
state: Texas
city: Austin
country: United States
facility: HTB Musculoskeletal Institute
state: Texas
city: Austin
country: United States
facility: Seton Institute for Plastic and Reconstructive Surgery
state: Texas
city: Austin
country: United States
facility: Orthopedic Specialists of Austin
state: Texas
city: Austin
country: United States
facility: ATX Ortho
state: Texas
Study officials:
References:
Clinical trial NCT01534312: Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)
Official title: Casein Glycomacropeptide in Active Distal Ulcerative Colitis (Pilot Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colitis, Ulcerative
Inflammatory Bowel Diseases
Keywords: Glycopeptides
Dietary proteins
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Arla Foods
First posted: 2012-02-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Casein glycomacropeptide (CGMP) has anti-inflammatory properties in experimental rodent colitis and using human in vitro inflammation models. Its use as a food ingredient has proven safe and with no influence on dietary intake. We hypothesize that orally administered CGMP has a beneficial effect comparable to that of mesalazine in active distal ulcerative colitis.

Detailed description: GCMP has mainly been used as food additive in patients with specific dietary needs, i.e. in infant formulas, adipositas, or in patient with phenylketonuria. Due to its antiinflammatory properties we hypothesize that it may be used alone or along with conventional therapy in inflammatory diseases such as ulcerative colitis.

Eligibility criteria: Inclusion Criteria:

* Age 18 years or more
* Diagnosed ulcerative colitis
* Signs of clinical activity with SCCAI of 3 or more
* Extension more than 10 cm and no more than 40 cm from anus

Exclusion Criteria:

* Rectal temperature more than 38 degrees Celcius
* Diagnosed celiac disease or lactose intolerance
* Unable to speak or understand Danish
* Prior biologics or systemic steroids 4 weeks up to inclusion

Primary outcomes:
measure: Fecal calprotectin reduction
timeFrame: 4 weeks
Secondary outcomes:
measure: Clinical activity index
timeFrame: 4 weeks
measure: Quality of life
timeFrame: 4 weeks
measure: Endoscopic Mayo score
timeFrame: 4 weeks
measure: Serial fecal calprotectin
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Department of medicine V (Hepatology and Gastroenterology)
Study officials:
affiliation: Professor, University of Aarhus
name: Hendrik Vilstrup, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01214512: Performance Evaluation of the Micromedic CD24 in Vitro Diagnostic Assay
Official title: Performance Evaluation of the Micromedic CD24 Western Blot and ELISA in Vitro Diagnostic Assay
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2010-10-05
Enrollment: 229
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects aged 50 years and above that are referred to colonoscopy assessment

Brief summary: This study is aimed to evaluate the performance of the Micromedic CD24 assay in identifying colorectal adenoma using Western blot and ELISA assays. These assays are designed to detect CD24 protein in peripheral blood leukocytes (PBL). Elevated levels of CD24 may be indicative of colorectal adenoma (inclusive of optically detectable early adenoma to late adenoma, and cancer).


Eligibility criteria: Inclusion Criteria:

* Subject is 50 years old and above
* Subject is asymptomatic and referred for regular recommended screening colonoscopy or subject is referred due to suspicion of colon cancer, prior to beginning of any treatment (enriched population)
* Subject signed the informed consent

Exclusion Criteria:

* Subject has been previously diagnosed with any type of cancer
* Subject has been previously diagnosed with a colorectal abnormality such as colorectal adenoma, hyperplastic polyp or carcinoma
* Blood sample was not collected on the day of colonoscopy and prior to colonoscopy
* Subject has first degree family history of colorectal cancer
* Subject has active infection or inflammation as determined clinically at screening
* Subject is currently taking medications related to the previous exclusion criteria
* Subject has participated in, or is participating in, any investigational drug or device study within 30 days prior the date of colonoscopy and any additional study required test
* Pregnant or lactating woman

Primary outcomes:
measure: Colonoscopy and CD24 assay correlation
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bat Yam
country: Israel
facility: Bat Yamon Gastroentrology Clinic
city: Tel Aviv
country: Israel
facility: Zamenhoff Gastroentrology Clinic
Study officials:
References:
Clinical trial NCT00567112: Study to Evaluate the Pharmacokinetics & Food Effect of MK-0941 in Adults With Type 2 Diabetes (MK-0941-009)
Official title: An Open-Label, Randomized, Partially Fixed-Sequence, 4-Period Crossover Study to Assess the Pharmacokinetics After Administration of the DFC and OCT Formulations and the Food Effect on the OCT Formulation of MK-0941 in Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-12-04
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A study to compare the pharmacokinetics (PK) of the dry filled capsule (DFC) \& oral compressed tablet (OCT) formulations of MK-0941-009 \& to assess the effect of food on the OCT formulation.


Eligibility criteria: Inclusion Criteria:

* Males or females (of non-childbearing potential) between the ages of 18 to 70
* Participants have been diagnosed with Type 2 Diabetes
* Participants are nonsmokers for at least 6 months

Exclusion Criteria:

* Participant should not be diagnosed with Type 1 diabetes
* Participant should not be receiving insulin or PPAR gamma agonists for 12 weeks prior to study start
* Participant has a recent history of eye infection or other inflammatory eye condition within 2 weeks prior to study start
* Participant has been diagnosed with glaucoma or is blind
* Participant has had trauma to one or both eyes
* Participant has had major surgery, donated blood or participated in another clinical study in the past 4 weeks
* Participant is a regular user of illicit drugs or has a history of drug, including alcohol, abuse in the past 6 months

Primary outcomes:
measure: Area Under the Curve (AUC)(0-∞) for Oral Compressed Tablet (OCT) (Fasted) and Dry Filled Capsule (DFC) (Fasted)
timeFrame: From study drug administration to 72 hours post-administration
measure: Maximum Concentration (Cmax) for OCT (Fasted) and DFC (Fasted)
timeFrame: From study drug administration to 72 hours post-administration
measure: Time to Reach Cmax (Tmax) for OCT (Fasted) and DFC (Fasted)
timeFrame: From study drug administration to 72 hours post-administration
measure: Half Life (t½) for OCT (Fasted) and DFC (Fasted)
timeFrame: From study drug administration to 72 hours post-administration
Secondary outcomes:
measure: AUC(0-∞) for OCT (Fasted) and OCT (After Meal)
timeFrame: From study drug administration to 72 hours post-administration
measure: Cmax of OCT (Fasted) and OCT (After Meal)
timeFrame: From study drug administration to 72 hours post-administration
measure: Tmax for OCT (Fasted) and OCT (After Meal)
timeFrame: From study drug administration to 72 hours post-administration
measure: t1/2 for OCT (Fasted) and OCT (After Meal)
timeFrame: From study drug administration to 72 hours post-administration
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00837512: Insulin Delivery Using Microneedles in Type 1 Diabetes
Official title: Insulin Delivery Using Microneedles in Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Type 1 Diabetes Mellitus
Keywords: microneedle continuous subcutaneous insulin infusion
Lead sponsor: Emory University
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
First posted: 2009-02-05
Enrollment: 16
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The goal of this study is to determine if microneedles can effectively and painlessly deliver insulin to children and young adults with type 1 diabetes.


Eligibility criteria: Inclusion Criteria:

* ≥ 8 years of age
* \<19 years of age
* Type 1 Diabetes for at least 2 years
* Uses a conventional, FDA-approved insulin pump for the past year
* Uses Lispro insulin
* Mean hemoglobin A1C ≤ 8.5 % for the past year
* Body mass index ≤ 85th percentile for age
* Understand and be willing to adhere to the study protocol

Exclusion Criteria:

* Type 2 Diabetes
* Acanthosis nigricans
* Clinically significant major organ system disease
* On glucocorticoid therapy
* Insulin requirement ≥ 150 U/day
* Illness on the day of the study
* Cognitive impairment (IQ \< 85 or \> 2 grades behind age-appropriate grade)
* Pregnant or breast-feeding (if female).

Primary outcomes:
measure: Onset Time (Tmax)
timeFrame: 0, 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
References:
citation: Norman JJ, Brown MR, Raviele NA, Prausnitz MR, Felner EI. Faster pharmacokinetics and increased patient acceptance of intradermal insulin delivery using a single hollow microneedle in children and adolescents with type 1 diabetes. Pediatr Diabetes. 2013 Sep;14(6):459-65. doi: 10.1111/pedi.12031. Epub 2013 Mar 21.
Clinical trial NCT02647112: Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma
Official title: Utility of Bladder EpiCheck for Detection of Recurrent Urothelial Carcinoma A Multicenter, Prospective Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: Bladder cancer
Urine
Methylation
Lead sponsor: Nucleix Ltd.
Sponsor class: INDUSTRY
First posted: 2016-01-06
Enrollment: 1050
Sex: ALL
Minimum age (years): 22
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Clinical trial to determine the performance characteristics (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology.

Detailed description: Clinical trial to determine the performance characteristics (sensitivity and specificity) of the Bladder EpiCheck test compared to the gold standard cystoscopy and pathology in patients under monitoring for reccurrence of bladder cancer.

Eligibility criteria: Inclusion Criteria:

* Patient diagnosed with incident or recurrent urothelial cell carcinoma and undergoing surveillance monitoring for urothelial cell carcinoma
* Has all urothelial cell carcinoma tumor resected within the past 12 months
* Has a plan for cystoscopic surveillance

Exclusion Criteria:

* Planning to undergo radical cystectomy or chemotherapy-radiation for UCC

Primary outcomes:
measure: Sensitivity (the proportion of positives that are correctly identified as such by the gold standard)
timeFrame: Day 1
measure: Specificity (the proportion of negatives that are correctly identified as such by the gold standard)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Tubingen
country: Germany
facility: Tubingen University Medical Center
city: Kfar Saba
country: Israel
facility: Meir Medical Center
city: Amsterdam
country: Netherlands
facility: AMC Medical Center
city: Hengelo
country: Netherlands
facility: ZGT Medical Center
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: Barcelona
country: Spain
facility: Vall D'Hebron Medical Center
Study officials:
affiliation: Nucleix Ltd.
name: Shmulik Adler
role: STUDY_DIRECTOR
affiliation: Radboud University Medical Center
name: Fred Witjes, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01452412: Alkali Therapy in Chronic Kidney Disease
Official title: Placebo-controlled Randomized Clinical Trial of Alkali Therapy in Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Chronic Kidney Disease
Metabolic Acidosis
Keywords: Alkali
Sodium bicarbonate
Kidney disease
Acidosis
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: National Institutes of Health (NIH)
First posted: 2011-10-14
Enrollment: 149
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Kidney disease is a common medical condition. Individuals with kidney disease develop a build-up of acid in their blood. This acid can affect their muscles, bones, glucose metabolism and kidneys. The investigators will test alkali treatment, to treat acid build-up, in a randomized placebo-controlled clinical trial to evaluate effects on muscles, bones, glucose metabolism and kidney.


Eligibility criteria: Inclusion Criteria:

* Estimate GFR \<= 45 and \>15 ml/min/1.73m2
* Age \>18

Exclusion Criteria:

* Previous chronic treatment with alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda)
* bicarbonate level \<20 or \>25 mEq/L
* New York Heart Association Class III or IV heart failure
* Systolic blood pressure \>180 mmHg
* Initiation of ESRD treatment planned within 6 months
* Kidney transplantation
* Treatment with immunosuppressives within the last 3 months

Primary outcomes:
measure: Sit to Stand to Sit Speed: Time Taken to Sit to Stand to Sit 10 Times
timeFrame: 2 year
measure: DEXA of Wrist
timeFrame: 2 year
Secondary outcomes:
measure: Hand-grip Strength
timeFrame: 2 year
measure: Estimated GFR
timeFrame: 2 year
measure: Quality of Life - Physical Function Domain
timeFrame: 2 year
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Thomas Hostetter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brightwell CR, Kulkarni AS, Paredes W, Zhang K, Perkins JB, Gatlin KJ, Custodio M, Farooq H, Zaidi B, Pai R, Buttar RS, Tang Y, Melamed ML, Hostetter TH, Pessin JE, Hawkins M, Fry CS, Abramowitz MK. Muscle fibrosis and maladaptation occur progressively in CKD and are rescued by dialysis. JCI Insight. 2021 Dec 22;6(24):e150112. doi: 10.1172/jci.insight.150112.
citation: Melamed ML, Horwitz EJ, Dobre MA, Abramowitz MK, Zhang L, Lo Y, Mitch WE, Hostetter TH. Effects of Sodium Bicarbonate in CKD Stages 3 and 4: A Randomized, Placebo-Controlled, Multicenter Clinical Trial. Am J Kidney Dis. 2020 Feb;75(2):225-234. doi: 10.1053/j.ajkd.2019.07.016. Epub 2019 Nov 5.