louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03966014: Different Amoxicillin Treatment Regimens in Erythema Migrans Patients
Official title: Different Duration and Dosing of Amoxicillin in Patients With Erythema Migrans. A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Erythema Migrans
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
Collaborators: name: University of Ljubljana School of Medicine, Slovenia
First posted: 2019-05-29
Enrollment: 510
Sex: ALL
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 study is to compare the efficacy of different amoxicilline treatment regimens in patients with erythema migrans.


Eligibility criteria: Inclusion Criteria:

* erythema migrans

Exclusion Criteria:

* pregnancy
* extracutaneous manifestations of Lyme borreliosis
* immunocompromising state
* serious adverse event to beta lactam antibiotic
* receiving antibiotic with antiborrelial activity within 10 days

Primary outcomes:
measure: Number (frequency) of patients with objective manifestations of Lyme borreliosis or subjective Lyme borreliosis-associated/post-Lyme borreliosis symptoms
timeFrame: One year follow-up
Secondary outcomes:
measure: Number (frequency) of patients with nonspecific symptoms
timeFrame: One year follow-up
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
city: Ljubljana
country: Slovenia
facility: University Medical Centre Ljubljana
Study officials:
affiliation: Department of Infectious Diseases, University Medical Centre Ljubljana, Slovenia
name: Daša Stupica, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04008914: Readmission Risk Factors and Heart Failure With Preserved Ejection Fraction
Official title: Readmission Risk Factors and Heart Failure With Preserved Ejection Fraction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Preserved Ejection Fraction
Keywords: Heart Failure
Readmission Risks
Lead sponsor: Ascension Macomb-Oakland Hospital
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 492
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All

Brief summary: Retrospective review of 492 patient from a small community hospital who did not qualify for participation in the Connect HF study sponsored by DCRI.

Detailed description: Retrospective review of adults above the age of 18 with a primary diagnosis of HFpEF between August 2017 and March 2018. Subjects had to fall into one of two classifications (NYHA Class II-IV or ACC/AHA Stage B-D) and had a life expectancy greater than 6 months are included. Individuals with a terminal illness other than HF, prior heart transplant or on a transplant list, or current/ planned left ventricular assist device excluded. The primary objective of this study is to identify risk factors for readmission in patients discharged with a diagnosis of HFpEF.

Eligibility criteria: Inclusion Criteria:

* History of Heart failure diagnosis admitted for treatment
* Ejection fraction \< 40% by echocardiogram

Exclusion Criteria:

* Ejection fraction \>40% by echocardiogram
* Chronic Kidney disease requiring dialysis
* Terminal illness
* New onset diagnosis of Heart Failure

Primary outcomes:
measure: Readmission Risk Factors and Heart Failure with Preserved Ejection Fraction
timeFrame: August 1, 2017 though March 1, 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Warren
country: United States
facility: Ascension Macomb-Oakland Hospital
state: Michigan
Study officials:
affiliation: Ascension Macomb-Oakland Hospital
name: Dustin Harmon, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01158014: Fibrin Glue vs. Suture in Pterygium Surgery
Official title: Fibrin Glue vs. Vicryl Suture in Pterygium Surgery With Conjunctival Auto-graft
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conjunctival Autograft
Keywords: pterygium
conjunctival graft
recurrence
primary pterygium
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-07-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of Fibrin glue to place conjunctival graft will be as effective as suturing the graft, but will require much less operative time and will be better tolerated by the patients.

Detailed description: Pterygium surgery requires removal of the pterygia from cornea and conjunctiva and an additional technique to prevent recurrence which may be as high as 50%.

Suturing a conjunctival auto-graft has become one of the most popular and effective methods in preventing recurrence. However suturing requires long operative time (10-20 minutes with removal alone less than 5 minutes) and requires sutures removal after 1-2 weeks which is very inconvenient to the patient.

Using Fibrin Glue (Quixil) has been used in several places in pterygium surgery and we believe it will be as effective as suturing the graft, will use much less OR time (reduce surgery time from 40 minutes to 20-25 minutes) and will be less expensive since 2 ml glue (around 80US$) suffice for 10 cases, while one vicryl suture costs around 34 US$.

Eligibility criteria: Inclusion Criteria:

* primary pterygium
* healthy subject
* ability to attend follow-up visits

Exclusion Criteria:

* recurrent pterygium
* underwent previous surgery / intervention to treat pterygium
* ocular surface disease 0 minor

Primary outcomes:
measure: Pterygium recurrence
timeFrame: one year
Secondary outcomes:
measure: operation time
timeFrame: one year
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba_Medical_Center
Study officials:
References:
citation: Ratnalingam V, Eu AL, Ng GL, Taharin R, John E. Fibrin adhesive is better than sutures in pterygium surgery. Cornea. 2010 May;29(5):485-9. doi: 10.1097/ICO.0b013e3181c29696.
citation: Por YM, Tan DT. Assessment of fibrin glue in pterygium surgery. Cornea. 2010 Jan;29(1):1-4. doi: 10.1097/ICO.0b013e3181a38fda.
citation: Hall RC, Logan AJ, Wells AP. Comparison of fibrin glue with sutures for pterygium excision surgery with conjunctival autografts. Clin Exp Ophthalmol. 2009 Aug;37(6):584-9. doi: 10.1111/j.1442-9071.2009.02105.x.
Clinical trial NCT00918814: Dose Ranging and Dose Frequency of LIPO-102
Official title: A Dose-Ranging and Dose Frequency Study Evaluating the Safety and Efficacy of LIPO-102 for the Reduction of Abdominal Subcutaneous Adipose Tissue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Subcutaneous Adipose Tissue Reduction
Lead sponsor: Neothetics, Inc
Sponsor class: INDUSTRY
First posted: 2009-06-11
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dose Ranging and Dose Frequency of LIPO-102


Eligibility criteria: Inclusion Criteria:

* Male or non pregnant female
* Good general health
* Sufficient abdominal fat for injections
* Signed informed consent

Exclusion Criteria:

* Known hypersensitivity to study drugs
* Treatment with an investigational agent within 30 days of first dose

Primary outcomes:
measure: Safety: physical examinations, laboratory tests, AE assessment
timeFrame: 4 weeks treatment and 4 weeks follow up
Secondary outcomes:
measure: Efficacy: change in subcutaneous abdominal adipose tissue thickness
timeFrame: 4 weeks treatment and 4 weeks follow up
Other outcomes:
Locations:
city: San Diego
country: United States
state: California
city: Baltimore
country: United States
state: Maryland
Study officials:
References:
Clinical trial NCT04588714: Feasibility and Preliminary Effects of the Resilience-based, Energy Management to Enhance Wellbeing in Systemic Sclerosis (RENEW) Intervention
Official title: Feasibility and Preliminary Effects of the Resilience-based, Energy Management to Enhance Wellbeing in Systemic Sclerosis (RENEW) Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Scleroderma
Keywords: Peer mentor
Web-based
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study, one arm, pre-test, post-test trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: Researchers are testing a web-based peer-led program to help manage energy and symptoms in people who have scleroderma. Resilience-based, Energy Management to Enhance Wellbeing (RENEW) was created by researchers, doctors, and patients with scleroderma. The goal is to help people with scleroderma feel better.


Eligibility criteria: Inclusion Criteria:

* Have a diagnosis of systemic sclerosis including:

  * Diffuse or limited cutaneous
* Have access to a reliable, internet-connected device (e.g. computer, tablet)
* Be able to read, speak, and understand English
* Participants need to report a score of at least 4 on a scale of 0 - 10 of fatigue severity, a cut-off for at least moderate fatigue in other fatiguing conditions.

Exclusion Criteria:

* Complex, unstable health issues that would preclude full participation in the study
* Planning to start new treatment for fatigue, pain, mood during the study period

Primary outcomes:
measure: Feasibility as assessed by intervention participant retention
timeFrame: 12 weeks
measure: Feasibility as assessed by the participation in intervention related phone calls
timeFrame: 12 weeks
Secondary outcomes:
measure: Feasibility as assessed by active participant involvement
timeFrame: 12 weeks
measure: Feasibility as assessed by the peer mentor health coach time
timeFrame: 12 weeks
measure: Feasibility as assessed by the time spent in preparation for intervention phone calls
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Susan Murphy, ScD, OTR/L
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Michigan
name: Dinesh Khanna, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00319514: Weekly Versus 3-Weekly Docetaxel Plus Cisplatin for Advanced NSCLC
Official title: Randomized Phase II Trial of Two Different Schedules of Docetaxel Plus Cisplatin as First-Line Therapy in Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Non-Small Cell Lung Cancer
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2006-04-27
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the toxicity and efficacy of docetaxel and cisplatin combination on two schedules in patients with previously untreated, advanced NSCLC.

Detailed description: The combination of docetaxel 75 mg/m2 and cisplatin 60-80 mg/m2 administered every 3 weeks is one of the most commonly used chemotherapy regimen in Korea for the first-line treatment of advanced NSCLC. Although the 3-weekly regimen is active and tolerated, it is associated with a significant incidence of severe neutropenia, often complicated by fever. Therefore, there has been increasing interest in the use of a weekly administration of docetaxel as a way of reducing its hematologic toxicity. We designed this randomized phase II trial to evaluate the safety profile and antitumor activity of two different schedules of docetaxel plus cisplatin given as first-line therapy in patients with advanced NSCLC.

Eligibility criteria: Inclusion Criteria:

* histologically or cytologically proven non-small cell lung cancer
* no prior chemotherapy or only adjuvant chemotherapy which had been completed \>6 months before registration
* ECOG performance status 0 to 2
* measurable lesion(s)
* normal marrow, hepatic and renal functions
* provision of written informed consent

Exclusion Criteria:

* active infection or severe comorbidities
* history of anaphylaxis of any origin

Primary outcomes:
measure: Objective response rate
Secondary outcomes:
measure: Progression-free survival
measure: Overall survival
measure: Safety
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
Study officials:
affiliation: Gachon University Gil Medical Center, Incheon, Korea
name: Se Hoon Park, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02733614: Proof-of-concept Study to Assess the Efficacy and Safety of SRX246 in Adults With PTSD
Official title: A Proof of Concept (POC) Clinical Trial for Post-Traumatic Stress Disorder (PTSD) With a First-In-Class Vasopressin 1a Receptor Antagonist (SRX246)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: PTSD
Lead sponsor: Azevan Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Weill Medical College of Cornell University
name: United States Department of Defense
name: U.S. Army Medical Research and Development Command
First posted: 2016-04-11
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 18-week, crossover, double-blind, randomized, placebo controlled proof-of-concept study to assess the efficacy and safety of SRX246 (160 mg bid) vs placebo in 52 adult veterans and civilians with a primary diagnosis of PTSD. Subjects will be randomly assigned in a double-blind fashion to 2 groups in a crossover design. The first group will receive SRX246 for 8 weeks followed by 8 weeks of placebo, while the second group will receive placebo for 8 weeks followed by 8 weeks of SRX246. Both groups will engage in a 7-day washout period between treatments. Subjects will be assessed at baseline and then every 2 weeks during the trial using the CAPS.


Eligibility criteria: Inclusion Criteria:

* Medically stable, current diagnosis of PTSD

Exclusion Criteria:

* Medically unstable

Primary outcomes:
measure: Assessment of overall clinical improvement
timeFrame: 18 weeks
Secondary outcomes:
measure: Number of participants with treatment-related adverse events
timeFrame: 18 weeks
measure: Reduction in depressive symptoms
timeFrame: 18 weeks
measure: Reduction in anger and aggression
timeFrame: 18 weeks
measure: Reduction in irritability
timeFrame: 18 weeks
measure: Improvement in overall functioning
timeFrame: 18 weeks
measure: Improvement in quality of life
timeFrame: 18 weeks
measure: Improvement in sleep quality
timeFrame: 18 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
Study officials:
References:
Clinical trial NCT04700514: Effect of Anesthetic Drugs on Neurocognitive Function in Children With Retinoblastoma Requiring Multiple Anesthetic Exposure - Preliminary Study
Official title: Effect of Anesthetic Drugs on Neurocognitive Function in Children With Retinoblastoma Requiring Multiple Anesthetic Exposure - Preliminary Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retinoblastoma
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2021-01-08
Enrollment: 60
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study evaluate the effect of dexmedetomidine on intelligence test in pediatric patients with multiple anesthesia exposure. Children who are diagnosed with retinoblastoma and receive first exam under general anesthesia before age of 2 are included. Intelligence test will performed when patients' age are 4.


Eligibility criteria: Inclusion Criteria:

* Patients who are first diagnosed as retinoblastoma and scheduled for EUA and treatment under general anesthesia before age of 2

Exclusion Criteria:

-

Primary outcomes:
measure: IQ score at age of 4
timeFrame: year 4
measure: Developmental Test
timeFrame: year 4
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT06718114: A Study on Early Removal of Urinary Catheter After Gastric Cancer Surgery Applying ERAS Protocols
Official title: A Study on Early Removal of Urinary Catheter After Gastric Cancer Surgery Applying ERAS Protocols
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Catheter Removal After Surgery
Lead sponsor: Affiliated Hospital of Nanjing University of Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
First posted: 2024-12-05
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compared the immediate removal of urinary catheter and early removal of urinary catheter after radical gastrectomy to explore the feasibility of immediate removal of urinary catheter after radical gastrectomy, especially in the incidence of urinary retention, whether immediate removal is not inferior to early removal.


Eligibility criteria: Inclusion Criteria:

* underwent elective radical gastrectomy
* applied ERAS protocols during perioperative period
* aged 18～80 years old

Exclusion Criteria:

* benign prostatic hyperplasia
* urinary system stones, tumors, strictures, deformities or surgeries
* pelvic surgery history
* abnormal preoperative urine routine
* medication intake that affects urination function

Primary outcomes:
measure: postoperative urinary retention incidence
timeFrame: From urinary catheter removed to 6 hours after removal
Secondary outcomes:
measure: postoperative urinary tract infection incidence
timeFrame: from postoperative day 1 to postoperative day 7
measure: anxious status
timeFrame: postoperative day 1
measure: comfort status
timeFrame: postoperative day 1
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Affiliated Hospital of Nanjing University of Chinese Medicine
state: Jiangsu
Study officials:
References:
Clinical trial NCT00600314: Measurements of Resting Energy Expenditure in Patients With or at Risk of Developing Graft Versus Host Disease
Official title: Measurements of Resting Energy Expenditure in Patients With or at Risk of Developing Graft Versus Host Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Graft-Versus-Host Disease
Keywords: Graft-Versus-Host Disease
Transplantation, Allogeneic
Transplantation, Hematopoietic Stem Cell
Calorimetry, Respiration
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
First posted: 2008-01-24
Enrollment: 20
Sex: ALL
Minimum age (years): 7
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: High risk population: patients who are at high risk of developing acute or chronic Graft versus Host Disease (GVHD) following an allogeneic transplant.

GVHD population: patients with active GHVD, either acute or chronic

Brief summary: This study aims to show that the MedGem indirect calorimetry measurement device will be feasible to use in children with GVHD. Also, it aims to show that children with chronic GVHD will have elevated REE that is not adequately predicted by standard equations.

Detailed description: Chronic Graft versus Host Disease (GVHD) is an important cause of morbidity and mortality in patients undergoing allogeneic bone marrow and hematopoietic progenitor cell transplantation. In adults, it has been shown that patients with acute or chronic GVHD have an increase in their resting energy expenditure (REE), likely as a result of chronic systemic inflammation. These studies have not yet been performed in children. This study's objective is to determine the REE of pediatric patients with acute and chronic GVHD after hematopoietic stem cell transplantation (HSCT).

Eligibility criteria: Inclusion Criteria:

* Subjects must be 7-30 years of age
* Signed informed consent
* One of the following three criteria must be met:

  * Presence of grade II or greater acute GVHD as defined by Keystone criteria
  * Presence of clinically extensive chronic GVHD as defined by the revised Seattle criteria
  * Any subject identified prior to allogeneic transplant, or following allogeneic transplant, who is at risk for acute or chronic GVHD

Exclusion Criteria:

* Inability to meet the requirements of the study procedures
* Any subject who is receiving supplemental oxygen
* Withdrawal of consent

Primary outcomes:
measure: Feasibility - can the procedure be adequately performed in a child?
timeFrame: Spring of 2010
Secondary outcomes:
measure: Measure of resting energy expenditure - kcal/day and oxygen consumption (VO2 mL/min)
timeFrame: Spring of 2012
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Children's Memorial Hospital
state: Illinois
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Morris Kletzel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03095014: Myomectomy During Cesarean Section
Official title: Cesarean Myomectomy : Safety and Risk of Intrauterine Synechiae
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Myomectomy
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2017-03-29
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cesarean Myomectomy
Primary purpose: TREATMENT

Brief summary: Cesarean Myomectomy, safety and effect on uterine cavity.

Detailed description: this study aims to compare between women who underwent Cesarean Myomectomy and those who underwent Cesarean section only regarding the procedure safety and whether uterine cavity was affected later on.

Eligibility criteria: Inclusion Criteria:

* pregnant
* full term
* had uterine myoma

Exclusion Criteria:

* history of coagulation disorder
* antepartum hemorrhage
* previous myomectomy
* where additional operative procedures were performed

Primary outcomes:
measure: Mean change in Haemoglobin in gm/dl
timeFrame: 24 hours
Secondary outcomes:
measure: Duration of operation in hours
timeFrame: 2 hours
measure: intrauterine adesion adhesions
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Zagazig University
name: ibrahim A el sharkwy
role: PRINCIPAL_INVESTIGATOR
References: