louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05627284: A Prospective Clinical Trial of Colostomy-replacement Combined With Bio-mesh Placement in the Prevention of SSIH
Official title: A Prospective Clinical Trial of Colostomy-replacement Combined With Bio-mesh Placement in the Prevention of SSIH
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stoma Site Incisional Hernia
Keywords: Stoma Site Incisional Hernia
Colon cancer
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2022-11-25
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to explore the safety and effectiveness of stoma reversal combining bio-mesh placement in patients with high risk of stoma site incisional hernia (SSIH). The main questions it aims to answer are:

* Whether bio-mesh placement is safe for patients with a high risk of SSIH.
* Whether stoma reversal combining bio-mesh placement is a preventive strategy for patients with high risk of SSIH.
* Whether stoma reversal combining bio-mesh placement will trigger other complications.

Participants who are eligible and are enrolled in this study will receive stoma reversal combining bio-mesh placement surgery. After that, they will be followed up for one year to evaluate the occurrence of SSIH and other complications.


Eligibility criteria: Inclusion Criteria:

* Age: 18-75 years old;
* Patients should have colonic prophylactic stoma and have not received reversal yet;
* There are no obvious signs of tumor recurrence or metastasis in tumor patients before stoma resection;
* No serious underlying diseases, can tolerate general anesthesia surgery
* Preoperative ECOG (Eastern Cooperative Oncology Group) physical status score 0/1;
* Preoperative ASA (American Society of Anesthesiologists) grade I-III;
* Without vital organs function failure;
* All patients and their families signed informed consent before surgery.

Exclusion Criteria:

* Incapacitated persons;
* With a history of other types of hernia;
* Those who have had hernia mesh implantation before;
* Those who are allergic to bio-mesh or their components before;
* Combined with other surgeries;
* Severe mental illness;
* Severe respiratory disease;
* Severe liver and kidney insufficiency;
* Those who have absolute contraindications to surgery;
* Suffering from severe bleeding disorders or obvious abnormal coagulation function;
* History of unstable angina or myocardial infarction within 6 months;
* History of cerebral infarction or cerebral hemorrhage within 6 months;
* Continuous intravenous application of glucocorticoid within 1 month;
* The patient has participated or is participating in other clinical studies (within 6 months).

Primary outcomes:
measure: stoma site incisional hernia
timeFrame: one-year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT02239484: Evaluating a Pharmacokinetic Drug Interaction Between Tadalafil and Tamsulosin
Official title: An Open-label, Randomized, Multiple-dose Crossover Study to Evaluate a Pharmacokinetic Drug Interaction Between Tadalafil and Tamsulosin in Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Erectile Dysfunction
Benign Prostatic Hyperplasia
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2014-09-12
Enrollment: 30
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: We investigate the potential pharmacokinetic drug-drug interaction between Tadalafil and Tamsulosin in healthy male volunteers who receive Tadalafil alone, Tamsulosin alone, and both together in a 3 period repeatedly.


Eligibility criteria: Inclusion Criteria:

1. Healthy male volunteers, age 20 to 55 years.
2. The result of Body Mass Index(BMI) is not less than 19 kg/m2 , no more than 27 kg/m2
3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
2. Liver enzyme (AST, ALT) level exceeds one and a half times more than maximum normal range.
3. Systolic blood pressure \<90mmHg or Diastolic blood pressure \< 70 mmHg, systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg(Sitting blood pressure) during the screening procedure.

Primary outcomes:
measure: Tadalafil,Tamsulosin Cmax,ss
timeFrame: 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)
measure: Tadalafil,Tamsulosin AUCτ
timeFrame: 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)
Secondary outcomes:
measure: Tadalafil,Tamsulosin tmax,ss
timeFrame: 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)
measure: Tadalafil,Tamsulosin t1/2
timeFrame: 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)
measure: Tadalafil,Tamsulosin CL/Fss
timeFrame: 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)
measure: Tadalafil,Tamsulosin Vd/Fss
timeFrame: 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)
measure: Tadalafil,Tamsulosin Cav
timeFrame: 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)
measure: Tadalafil,Tamsulosin Cmin,ss
timeFrame: 6day 0h(predose), 0.5, 1, 2, 3, 4, 6, 7, 8, 10, 12, 24, 48, 72 hours (Total 14)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samgsung Seoul Hospital
Study officials:
References:
Clinical trial NCT04279184: Urinary Incontinence and Endocrine Factors. A Part of Lolland-Falster Health Study (LOFUS).
Official title: Urinary Incontinence and Endocrine Factors.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Incontinence
Diabetes
Thyroid Diseases
Lead sponsor: Nykøbing Falster County Hospital
Sponsor class: OTHER
Collaborators: name: Region Zealand
name: Zealand University Hospital
name: University of Southern Denmark
First posted: 2020-02-21
Enrollment: 6000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population of Lolland and Guldborgsund municipalities in Denmark.

Brief summary: Previous studies have shown an increase in the prevalence of urgency and urgency incontinence in women with diabetes. Regarding the condition urinary stress incontinence, the literature is diverted.

The purpose of the PhD project is investigate the prevalence of urinary incontinence and the association to diabetes and thyroid disease in a mainly rual population in Lolland and Falster. Further to investigate if there is any difference in the bladder function in incontinent women with and without diabetes.

Psychometric validation of the questionnaire used to assess urinary incontinence was also performed.


Eligibility criteria: Inclusion Criteria:

* woman
* 18 years or above
* participating i The Lolland-Falster Health Study (NCT02482896)

Exclusion Criteria:

* male
* below 18 years
* non-participating i The Lolland-Falster Health Study

Primary outcomes:
measure: Prevalence of urinary incontinence
timeFrame: 4 years
measure: Psychometric validation of ICIQ-UI SF (questionnaire used to assess urinary incontinence)
timeFrame: 2 years
Secondary outcomes:
measure: Association between urinary incontinence and diabetes
timeFrame: 4 years
measure: Participants demographics
timeFrame: 4 years
measure: Objective characterization of urinary incontinence in women with and without diabetes
timeFrame: 2 years
Other outcomes:
Locations:
city: Nykøbing Falster
country: Denmark
facility: Randi Jepsen
state: Danmark
Study officials:
affiliation: Zealand University Hospital
name: Helga Gimbel
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02562079: Vasculopathy, Inflammation and Systemic Sclerosis
Official title: Vasculopathy, Inflammation and Systemic Sclerosis: The Role of Endothelial Cell Activation and OX40/OX40L in Modulation of T Lymphocyte Activation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Sclerosis
Keywords: T lymphocyte
OX40/OX40L
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
Collaborators: name: Societe Francaise de Rhumatologie
First posted: 2015-09-29
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: It is a study of basic research with mechanistically objectives and including clinical biological samples.

Detailed description: Systemic sclerosis (SSc) is a rare and severe disease characterised by a fibrotic process and an incompletely elucidate physiopathology. Several shared featured have been identified between SSc and another autoimmune disease, the systemic lupus erythematous (SLE) as an interferon-alpha signature, the role of platelets and the polymorphism of OX40 ligand (OX40L). In SLE, OX40L has been shown highly linked to the active form of the disease, was increased by the CD40L of platelets and induced the CD8 cytotoxicity while inhibiting the suppressive functions of regulator T lymphocytes. The third main factor of the SSc physiopathology apart from autoimmunity and fibrosis is the vasculopathy with an important role of endothelial cells (EC). They turned out to be half-professional antigen presenting cells and can modulate the adaptive immunity.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 75.
* SSc diagnosed according to the American College of Rheumatology (ACR) criteria.
* With skin manifestations since less than 10 years.
* Localised sclerosis (LSc) diagnosed, morphea type.

Exclusion Criteria:

* Age inferior to 18 or upper than 75.
* Skin manifestations since more than 10 years.
* Haemostasis diseases (independent from treatments).
* Stem cell transplant.
* Immunosuppressive treatments in the last 6 months.
* Associate autoimmune disease.

Primary outcomes:
measure: Assessment of OX40L expression in endothelial cells and skin biopsies.
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Service de Rhumatologie - Tripode - Hôpital Pellegrin
Study officials:
affiliation: University Hospital Bordeaux, France
name: Marie-Elise TRUCHETET, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03845179: GA 6: The Blood Glucose-lowering Effect of Glucose-dependent Insulinotropic Polypeptide
Official title: The Blood Glucose-lowering Effect of Glucose-dependent Insulinotropic Polypeptide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type2 Diabetes
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2019-02-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, placebo-controlled, cross-over.
Primary purpose: BASIC_SCIENCE

Brief summary: This study will investigate if the effect of DPP-4 inhibitors is mediated in part by Glucose-dependent insulinotropic polypeptide.

Detailed description: A randomized, placebo controlled study. Using a GIP receptor antagonist, we will investigate the glucose lowering effect of GIP during treatment with DPP-4 inhibitors.

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes, treatment: lifestyle changes or metformin
* HbA1c \< 75 mmol/mol

Exclusion Criteria:

* diagnosed liver disease
* eGFR \< 60 ml/min/1,73m2
* NYHA III or IV
* anemia.

Primary outcomes:
measure: C-peptide
timeFrame: 5 hours
Secondary outcomes:
measure: Plasma glucose
timeFrame: 5 hours
measure: Insulin
timeFrame: 5 hours
measure: Total and intact GIP
timeFrame: 5 hours
measure: Total and intact GLP-1
timeFrame: 5 hours
measure: Glucagon
timeFrame: 5 hours
measure: CTX
timeFrame: 5 hours
measure: Lipids
timeFrame: 5 hours
Other outcomes:
measure: Gallbladder volume
timeFrame: 5 hours
measure: Systolic and diastolic blood pressure
timeFrame: 5 hours
measure: heart rate
timeFrame: 5 hours
Locations:
city: Copenhagen
country: Denmark
facility: Center for Clinical Metabolic Research
state: Hellerup
Study officials:
References:
citation: Stensen S, Gasbjerg LS, Rosenkilde MM, Vilsboll T, Holst JJ, Hartmann B, Christensen MB, Knop FK. Endogenous Glucose-Dependent Insulinotropic Polypeptide Contributes to Sitagliptin-Mediated Improvement in beta-Cell Function in Patients With Type 2 Diabetes. Diabetes. 2022 Oct 1;71(10):2209-2221. doi: 10.2337/db22-0059.
Clinical trial NCT03530579: Community Health Worker Diabetes Prevention Intervention
Official title: Community Health Worker Diabetes Prevention Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Prevention
Keywords: Diabetes Prevention
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-05-21
Enrollment: 954
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary goal of this study is to develop, implement, and test a community health worker (CHW) program designed to promote diabetes prevention among Korean and South Asian Americans in New York City.

In particular, the specific aims of this study are:

1. To utilize community based participatory research (CBPR) methods to expand upon an existing campus-community partnership to develop and implement a CHW program among Korean and South Asian Americans that promotes diabetes prevention;
2. To develop, implement, and assess the efficacy of a CHW intervention to promote diabetes prevention and access to care among NYC Koreans and South Asians.


Eligibility criteria: Inclusion Criteria:

* is a South Asian or Korean American immigrant;
* is identified as at-risk by a diabetes risk assessment
* is between 18-75 years of age; and
* is willing to be randomized to either treatment or control groups.

Exclusion Criteria:

* is a confirmed diabetic;
* is on renal dialysis;
* has an acute or terminal illness or serious mental illness;
* has a history of recent coronary event within the last 12 months;
* has a recent history of acute medical problem or admission to hospital;
* has any other severe medical conditions that might make it difficult to attend educational sessions;
* has poor short-term prognosis (expected death in \<2 years);
* is planning to travel for longer than 6 weeks during the 6-month intervention period; or
* is participating in another CVD study.

Primary outcomes:
measure: Change in weight
timeFrame: 3 Months, 6 Months, 12 Months
measure: Change in Body Mass Index
timeFrame: 3 Months, 6 Months, 12 Months
measure: Change in hip-to-waist ratio measurements
timeFrame: 3 Months, 6 Months, 12 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: NYU Langone Health
name: Nadia Islam, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wyatt LC, Katigbak C, Riley L, Zanowiak JM, Ursua R, Kwon SC, Trinh-Shevrin C, Islam NS. Promoting Physical Activity Among Immigrant Asian Americans: Results from Four Community Health Worker Studies. J Immigr Minor Health. 2023 Apr;25(2):291-305. doi: 10.1007/s10903-022-01411-y. Epub 2022 Oct 23.
Clinical trial NCT06384079: Duration of Ureteral Rest Prior to Ureteral Reconstruction Surgery
Official title: Study to Assess Duration of Ureteral Rest Prior to Ureteral Reconstruction Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ureteral Stricture
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects over 18 years of age undergoing surgery to fix the ureter.

Brief summary: Our objective is to assess the effect of duration of ureteral rest, defined as time from conversion of ureteral stent to percutaneous nephrostomy, on stricture length prior to ureteral reconstruction surgery.


Eligibility criteria: Inclusion Criteria:

* \>18 years of age
* Undergoing ureteral reconstruction surgery for ureteral stricture with conversion of an indwelling stent to a percutaneous nephrostomy tube for ureteral rest
* Willing to sign informed consent form
* Able to read and understand informed consent form

Exclusion Criteria:

* \<18 years of age
* Inability to provide informed consent
* Members of vulnerable patient populations

Primary outcomes:
measure: Ureteral stricture length measured by antegrade or retrograde pyelogram
timeFrame: 2 weeks and 6 weeks post procedure
Secondary outcomes:
measure: Ureteral Stricture Quality will be graded as either narrowed or obliterated segment.
timeFrame: 2 weeks and 6 weeks post procedure
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References:
Clinical trial NCT01329679: Impact of Energy Drinks on Cardiovascular Endpoints
Official title: Effects of Single and Multiple Energy Shots on Blood Pressure and Electrocardiographic Parameters: A Randomized, Double Blind, Crossover, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: David Grant U.S. Air Force Medical Center
Sponsor class: FED
First posted: 2011-04-06
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Objective: To assess the cardiac effects of a an energy drink on blood pressure and heart rhythm in healthy subjects.

Study design: Double blind, placebo controlled, cross-over

Study population: Healthy human volunteers (active-duty) between age 18 to 40 years with no other medical conditions.

Intervention: Energy drink or Placebo

Primary outcome: Change in office systolic blood pressure


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers between ages 18-40 years
* ONLY "as needed" use of ibuprofen or acetamenophen
* Active duty military
* DoD beneficiary or Civilian Government Employees

Exclusion Criteria:

* No other co-morbid conditions
* No active prescription or OTC drug use
* Not pregnant or planning to become pregnant during study participation

Primary outcomes:
measure: Change in Office Systolic Blood Pressure
timeFrame: At baseline and 7 days post energy drink and placebo consumption
Secondary outcomes:
measure: Office DBP After a Single Energy Shot and After Chronic Consumption
timeFrame: At baseline and 7 days post energy drink and placebo consumption
measure: Max Heart Rate After a Single Shot and After Chronic Consumption
timeFrame: At baseline and 7 days post energy drink and placebo consumption
measure: Max PR-interval After a Single Shot and After Chronic Consumption
timeFrame: At baseline and 7 days post energy drink and placebo consumption
measure: Max QRS Duration After a Single Shot and After Chronic Consumption
timeFrame: At baseline and 7 days post energy drink and placebo consumption
measure: Max QT Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7
timeFrame: At baseline and 7 days post energy drink and placebo consumption
measure: Max QTc Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7
timeFrame: At baseline and 7 days post energy drink and placebo consumption
Other outcomes:
Locations:
Study officials:
affiliation: David Grant Medical Center
name: Shah Sachin, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00861679: Therapy Protocol Acute Lymphoblastic Leukemia Stem Cell Transplantation International
Official title: Therapy Protocol ALL SCT BFM International-open, Multicenter, Controlled, Prospective Study for Therapy and Therapy Optimisation in Patients With Acute Lymphoblastic Leukemia (ALL) and an Indication for Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Lymphoblastic Leukemia
Keywords: HSCT
ALL
GvHD
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-03-13
Enrollment: 552
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate whether HSCT from matched family or unrelated donors (MD) is equivalent to the HSCT from matched sibling donors (MSD). To evaluate the efficacy of HSCT from mismatched family or unrelated donors (MMD) as compared to HSCT from MSD/MD. To determine whether therapy has been carried out according to the main HSCT protocol recommendations. The standardisation of the treatment options during HSCT from different donor types aims at the achievement of an optimal comparison of survival after HSCT with survival after chemotherapy only. To prospectively evaluate and compare the incidence of acute and chronic GvHD after HSCT from MSD, from MD and from MMD.


Eligibility criteria: Inclusion Criteria:

all patients with ALL (except for patients with B-ALL) who fulfil the following criteria:

* age at time of initial diagnosis or relapse diagnosis, respectively

  ≤18 years
* indication for allogeneic HSCT
* complete remission (CR) is achieved before SCT
* written consent of the parents (legal guardian) and, if indicated, the minor patient via "Informed Consent Form"
* no pregnancy
* no secondary malignancy
* no previous HSCT
* HSCT is performed in a study participating centre.

Exclusion Criteria:

* not signed inform consent of the parents (legal guardian)
* pregnancy
* secondary malignancy
* previous HSCT

Primary outcomes:
measure: event-free and overall survival after allogeneic HSCT, occurrence of acute and chronic Graft-versus-Host-Disease (GvHD), occurrence and course of late effects after chemotherapy with subsequent allogeneic HSCT
timeFrame: 11 years
Secondary outcomes:
Other outcomes:
Locations:
city: Petach Tikvah
country: Israel
facility: Schneider Children's Medical Center of Israel
Study officials:
References: