louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00609986: IV Insulin Protocol in Diabetes and Renal Transplantation
Official title: Intravenous Insulin Protocol in Diabetes and Renal Transplantation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Transplantation
Diabetes
Hyperglycemia
Keywords: Kidney
Transplantation
Diabetes
Hyperglycemia
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2008-02-07
Enrollment: 104
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: Purpose: The purpose of this study is to provide tight blood sugar control using insulin given through the veins at the time of kidney transplantation and up to 3 days after surgery. After release from the hospital, the patient will control blood sugar with subcutaneous insulin injections or pills. With this approach, outcomes should improve for diabetic transplant patients such as longer life of the new kidney, fewer hospital readmissions, decreased associated infections, and other advantages.

Hypothesis: It is hypothesized that intensive glycemic control will lead to better clinical and biochemical outcomes and improved long-term graft survival.

Detailed description: Research Design: A randomized control trial comparing intensive intravenous insulin (IVI) for use in the hospital followed by intensive subcutaneous (sc) insulin use for in-patient and out-patient glycemic control will be conducted.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and greater,
* Diabetes diagnosis (Type 1 and Type 2, awaiting a living or cadaveric renal transplant, renal transplant candidates admitted to MUSC medical center for a donor kidney, FBG \>100 mg/dL per admission screening labs, random BG \>120mg/dL per admission screening labs, and
* Willing and able to provide informed consent

Exclusion Criteria:

* History of an active GI bleed in the previous 3 mos,
* Scheduled to receive a simultaneous pancreas transplant,
* History of a functioning pancreatic transplant,
* Patient currently managed on an insulin pump,
* Unable or unwilling to provide informed consent, and
* Unable to commit to the study protocol including the outpatient follow-up phase of care

Primary outcomes:
measure: Delayed Graft Function
timeFrame: 10 days
measure: Acute/Active Rejection
timeFrame: 30 months
Secondary outcomes:
measure: Severe Hypoglycemia
timeFrame: 30 months
measure: Severe Hyperglycemia
timeFrame: 30 months
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina, Division of Endocrinology
name: Kathie L. Hermayer, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lo C, Toyama T, Oshima M, Jun M, Chin KL, Hawley CM, Zoungas S. Glucose-lowering agents for treating pre-existing and new-onset diabetes in kidney transplant recipients. Cochrane Database Syst Rev. 2020 Jul 30;8(8):CD009966. doi: 10.1002/14651858.CD009966.pub3.
Clinical trial NCT06292286: Secondary Interval Cytoreductive Surgery in Platinum-sensitive Recurrent Epithelial Ovarian Cancer
Official title: Secondary Neoadjuvant Chemotherapy and Interval Cytoreductive Surgery in Platinum-sensitive Recurrent Epithelial Ovarian Cancer Patients - a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Recurrent Ovarian Carcinoma
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-03-05
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Neoadjuvant carboplatin and paclitaxel followed by cytoreductive surgery
Primary purpose: TREATMENT

Brief summary: About 80% of advanced ovarian cancer patients recurred in 2-3 years. Secondary cytoreduction benefits selected patients who have high chance of complete resection. Whether secondary interval surgery can be used at recurrence is not known.

Detailed description: Our study aims to evaluate the complete resection rate at interval cytoreductive surgery for recurrent ovarian cancer patients, and to determine the safety and survival outcomes of this approach.

Eligibility criteria: Inclusion Criteria:

* Histologically diagnosed EOC, fallopian tube or primary peritoneal carcinoma
* \>= 3 cycles of platinum-based chemotherapy, with or without bevacizumab and / or PARPi, at primary setting
* Platinum-free interval should be \>=6 months from the last dose of platinum-based chemotherapy
* Upfront SCR not feasible
* Patients should have Eastern Cooperative Oncology Group (ECOG) performance score 0 to 2 within 28 days prior to recruitment.
* Patients must have adequate bone marrow, renal, hepatic and neurological function within 28 days prior to the start of treatment.

Exclusion Criteria:

* Non-epithelial or borderline tumors are excluded
* Patients who have with concurrent malignancy within five years (except for basal or squamous cell skin cancer, in-situ breast cancer, stage 1a grade 1-2 endometrioid endometrial carcinoma without lymphovascular invasion) are excluded.
* Patients using more than one line of chemotherapy are excluded.
* Patients who have platinum-resistant or refractory recurrence are excluded.
* Patients having second relapse or beyond are excluded.
* Patients who have contraindications to operation, e.g., unresolved thrombocytopenia, bowel obstruction in the last 4 weeks prior to enrolment

Primary outcomes:
measure: Complete resection rate
timeFrame: 12 months
Secondary outcomes:
measure: 12-month progression-free survival rate
timeFrame: 12 months
measure: 12-month overall survival rate
timeFrame: 12 months
measure: Surgical complication rate
timeFrame: 12 months
measure: Quality of life scale
timeFrame: 12 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Ka Yu Tse
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00756886: Does Atorvastatin Prevent Post Operative Atrial Fibrillation After Pulmonary Resection: A Randomized Clinical Study
Official title: Does Atorvastatin Prevent Post Operative Atrial Fibrillation After Pulmonary Resection: A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arrhythmia
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-09-22
Enrollment: 73
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if atorvastatin (Lipitor) reduces the occurence of abnormal heart rhythm (atrial arrhythmia) following non cardiac thoracic surgery.

Detailed description: The incidence of atrial arrhythmia after thoracic, non-cardiac procedures is exceedingly common and has been reported to occur in between 10-39% of patients. It has been shown to increase majority morbidity and also delay hospital discharge. Recent studies suggest that one week of pre-operative atorvastatin may reduce the incidence of post-operative atrial arrhythmia in patients who undergo cardiac surgery and a multi-institutional study is currently underway to further examine this concept. However, there are no published prospective randomized studies to date that have evaluated the effectiveness of atorvastatin to reduce atrial arrhythmia in patients who undergo thoracic, non-cardiac operations such as esophagectomy or pulmonary resection. The object of this study is to determine if atorvastatin reduces the incidence of atrial arrhythmia (atrial fibrillation or flutter) following non-cardiac thoracic surgery, specifically pulmonary resections.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective non-cardiac thoracic surgery requiring thoracotomy for resection

Exclusion Criteria:

* Past medical history of pacemaker implantation
* Pregnancy or lactating
* History of Atrial arrhythmia within the past year
* Elevated liver enzymes pre-operatively
* Past medical history of any liver disease or history of liver transplantation
* Use of statins or any anti-arrhythmics (including beta-blockers, calcium channel blockers, digoxin) within 3 months prior to surgery
* Pre-op EKG showing atrial arrhythmia

Primary outcomes:
measure: Atrial Fibrillation
timeFrame: 0-21 days post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham, Department of Surgery
name: Robert J Cerfolio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05694286: A Prospective Evaluation of Infraorbital Filler Injection
Official title: A Prospective Evaluation of Infraorbital Filler Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dermal Filler
Rejuvenation
Keywords: injectables
tear trough rejuvenation
aesthetic improvement
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 11
Sex: FEMALE
Minimum age (years): 22
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 goal of this clinical trial is to measure the facial volumetric changes over time in patients injected with hyaluronic acid dermal filler (Juvéderm Volbella XC) in the infraorbital (under eye) region. Participants will be injected with Juvéderm Volbella XC filler and asked to return for 3D photography at 2 weeks, 1 month, and 3 months post-injection.

Detailed description: Undereye or infraorbital hollowing is a result of a loss of volume causing shadowing and darkness of the infraorbital region often interpreted as a tired, stressed, and aged appearance.

The goal of this clinical trial is to measure the facial volumetric changes over time in patients injected with hyaluronic acid dermal filler (Juvéderm Volbella XC) in the infraorbital (under eye) region. Participants will be injected with Juvéderm Volbella XC filler and asked to return for 3D photography and to complete a validated patient satisfaction questionnaire at 2 weeks, 1 month, and 3 months post-injection. 3D photogrammetry technology allows for high level feature enhancement and microscopic anatomical evaluation that was not previously possible and can be used to make volumetric measurements at injection sites to evaluating minimally invasive injection efficacy.

Eligibility criteria: Inclusion Criteria:

* female
* age 22 to 65
* interested in filler injections to reduce undereye volume loss

Exclusion Criteria:

* male
* age \<22 or \>65
* prior undereye filler
* filler/neurotoxin injection within the past 12 months
* prior facial cosmetic surgery
* prior facial trauma
* planned dental work within next 2 weeks
* travel 1 week prior or 2 weeks after injection

Primary outcomes:
measure: Volumetric Change in Infraorbital Treatment Baseline to Each Post-intervention Timepoint Day 14, Day 30, and Day 90
timeFrame: Post-intervention, Day 14, Day 30, Day 90
Secondary outcomes:
measure: Patient Satisfaction With Validated the Questionnaire FACE-Q
timeFrame: Day 0 pre-intervention, Day 0 post-intervention, Day 14, Day 30, Day 90
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Medicine
state: Pennsylvania
Study officials:
affiliation: Penn Medicine
name: Ivona Percec, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05061186: Resistive Expiratory Muscle Training in COPD Patients
Official title: Effects of Resistive Expiratory Muscle Training on Pulmonary Functions in Patients With COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
Keywords: Resistive Expiratory Muscle training
Breathing Exercise
Pulmonary Function
Quality of Life
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2021-09-29
Enrollment: 74
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: * To determine effects of resistive expiratory muscle training on pulmonary functions in Chronic obstructive pulmonary disease (COPD) patients
* To determine effects of resistive expiratory muscle training on maximum expiratory pressure in COPD patients
* To determine effects of resistive expiratory muscle training on quality of life in COPD patients


Eligibility criteria: Inclusion Criteria:

* COPD patients (GOLD criteria - moderate, moderately severe)
* Borg scale \< 4

Exclusion Criteria:

* Patients with Orthopedic disease
* Neurological disease,
* Cognitive impairment (Mini-Mental State Examination \< 22) ,
* Heart diseases,
* Pulmonary fibrosis
* Obstructive sleep apnea syndrome.
* Acute and chronic infections

Primary outcomes:
measure: Maximum expiratory pressure
timeFrame: 6 weeks
measure: St George's Respiratory Questionnaire
timeFrame: 6 Week
measure: Forced Expiratory Volume in 1 second (FEV1)
timeFrame: 6 Week
measure: Forced vital Capacity (FVC)
timeFrame: 6 week
measure: Peak Expiratory Flow (PEF)
timeFrame: 6 Week
measure: Volume of Lungs inflation
timeFrame: 6 week
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Holy Family Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Iqbal Tariq, MSCPPT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05072886: Study of Efficacy and Safety of Investigational Treatment in Patients With Nail Psoriasis
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase 1b Study Followed by an Open-Label Extension to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Topical AT193 in the Treatment of Patients With Nail Psoriasis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Nail Psoriasis
Plaque Psoriasis
Lead sponsor: Azora Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2021-10-11
Enrollment: 34
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: Part 1 is a randomized, double-blind, placebo-controlled phase 1b study to evaluate AT193 in approximately 34 patients with nail psoriasis for 16 weeks. Part 2 is an open-label extension phase where all patients will receive active drug for an additional 16 weeks followed by a 2 week nontreatment period.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of nail psoriasis for at least 3 months preceding study entry
* Diagnosis or history of plaque psoriasis or psoriatic arthritis
* A female participant of childbearing potential must use appropriate contraceptive measures during the study period
* A female participant of childbearing potential must have a negative urine pregnancy test result at screening
* Written informed consent must be obtained before any study procedure is performed

Exclusion Criteria:

* Pregnant or breastfeeding
* Diagnosis of other active skin or nail diseases or skin or nail infections (bacterial, fungal, or viral) that may interfere with evaluation of skin or fingernail psoriasis
* History or evidence of a clinically significant disorder, condition, or disease that would pose a risk to patient safety or interfere with the study evaluation, procedures, or completion in the judgment of the investigator

Primary outcomes:
measure: Incidence of treatment-emergent adverse events
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: East Melbourne
country: Australia
facility: Sinclair Dermatology
state: Victoria
Study officials:
References:
Clinical trial NCT00253786: Study for the Effectiveness of Intensive Therapy Aiming at a Remission of Diabetic Nephropathy
Official title: Study for the Effectiveness of Intensive Therapy for Diabetic Nephropathy in Unblinded, Randomized Intergroup Comparison Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Diabetic Nephropathy
Keywords: diabetes
nephropathy
Lead sponsor: Okayama University
Sponsor class: OTHER
First posted: 2005-11-15
Enrollment: 312
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study for the effectiveness of intensive therapy aiming at the remission of diabetic nephropathy

Detailed description: Study for the effectiveness of intensive therapy for diabetic nephropathy in unblinded, randomized intergroup comparison study.

Eligibility criteria: Inclusion Criteria:

1. Patients with type 2 diabetes
2. Urinary albumin-to-creatinine ratio: \>=300 mg/g creatinine twice in the first morning urine sample
3. Serum creatinine level: =\<2.5 mg/dl
4. Patients aged 20-75 years

Exclusion Criteria:

1. Type 1 diabetes
2. Hereditary diabetes or secondary diabetes
3. Non-diabetic nephropathy
4. Familial hypercholesterolemia
5. Secondary hypertension
6. Unstable angina pectoris or history of myocardial infarction/stroke within 6 months prior to consent acquisition
7. Malignant tumor or life threatening disease
8. History of angioedema
9. Patients undergoing LDL apheresis
10. Biliary system obstruction or severe liver injury
11. Liver dysfunction
12. Allergy for ACE-Is, ARBs or HMG-CoA reductase inhibitors
13. Pregnant or nursing patients
14. Others: patients who are not suitable for this trial

Primary outcomes:
measure: Urinary protein/creatinine ratio (in the first morning urine sample) in Protocol A
timeFrame: 5 years
measure: Composite endpoint of time to first occurrence of (1) Doubling of serum creatinine, (2) Need for chronic dialysis or renal transplantation, or (3) Death in Protocol B
timeFrame: 5 years
Secondary outcomes:
measure: GFR in Protocol A
timeFrame: 5 years
measure: Cardiovascular event in Protocol A
timeFrame: 5 years
measure: Progression of retinopathy in Protocol A
timeFrame: 5 years
measure: Urinary albumin/creatinine ratio in Protocol A
timeFrame: 5 years
measure: Proteinuria (24 h collection sample) in Protocol A
timeFrame: 5 years
measure: GFR in Protocol B
timeFrame: 5 years
measure: Cardiovascular event in Protocol B
timeFrame: 5 years
measure: Progression of retinopathy in Protocol B
timeFrame: 5 years
measure: Urinary albumin/creatinine ratio in Protocol B
timeFrame: 5 years
measure: Urinary protein/creatinine ratio in Protocol B
timeFrame: 5 years
Other outcomes:
Locations:
city: Okayama
country: Japan
facility: Okayama University Hospital
Study officials:
affiliation: Okayama University, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
name: Hirofumi Makino, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05624086: Hepatic Enzymes, Psychological Measures, and Sexual Dysfunction Responses to Aerobic Exercise in Hepatitis-C Men
Official title: Is There a Response of Hepatic Enzymes, Psychological Measures, and Sexual Dysfunction to Aerobic Exercise in Men With Sexual Dysfunction Complaint and Hepatitis C
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatitis C
Erectile Dysfunction
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-11-21
Enrollment: 46
Sex: MALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic hepatitis C virus (HCV) infection is a systematic disease that affects several aspects of patients' well-being, including physical, mental, social, and sexual quality of life. In recent years, this clinical trial aims to search the Response of Hepatic Enzymes, Psychological Measures, and Sexual Dysfunction to Aerobic Exercise in Hepatitis Men With Sexual Dysfunction Complaint

Detailed description: Hepatitis Men With Sexual Dysfunction (erectile dysfunction) Complaint (n=46) will be randomized randomly to 23-men exercise-training (one hour walking on treadmill, for 3 months, three walking sessions per the week) hepatitis-C group or 23-men waiting-hepatitis-C group.

Eligibility criteria: Inclusion Criteria:

* men with hepatitis C men diagnosis
* men with sexual dysfunction (erectile dysfunction)

Exclusion Criteria:

* obesity , men with cardiac/thoracic/systemic diseases, drugs for sexual dysfunction (erectile dysfunction)

Primary outcomes:
measure: International Index of Erectile Function (IIEF-5)
timeFrame: It will be measured after 12 weeks of training
Secondary outcomes:
measure: alanine transaminase
timeFrame: It will be measured after 12 weeks of training
measure: aspartate transaminase
timeFrame: It will be measured after 12 weeks of training
measure: Rosenberg Self-Esteem Scale
timeFrame: It will be measured after 12 weeks of training
measure: Profile of Mood States
timeFrame: It will be measured after 12 weeks of training
measure: depression inventory of Beck
timeFrame: It will be measured after 12 weeks of training
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo Unoversity
Study officials:
affiliation: Cairo University
name: Ali Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References: