louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00057590: Outreach and Treatment for Depression in the Labor Force
Official title: Outreach and Treatment for Depression in the Labor Force
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Harvard Medical School (HMS and HSDM)
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-04-08
Enrollment: 590
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: This study will assess the effects of depression treatment on employee productivity. This study will also evaluate the impact of depression screening and outreach on employees' receptivity to treatment.

Detailed description: This study is conducted in three phases. In the first phase, employees from various companies participate in an on-line Health Risk Assessment survey at a secure website. Those who display symptoms of depression participate in a brief telephone interview to confirm the depression diagnosis.

In the second phase, depressed participants are randomly assigned to receive either intervention treatment or usual care for 18 months. The intervention consists of periodic telephone contact with a mental health clinician who provides education regarding depression and its treatment. Participants receiving the intervention are also provided with resources to obtain psychotherapy and/or pharmacotherapy. Those who do not seek treatment are monitored and supported. Participants in the usual care arm are informed of their possible depression and are encouraged to seek professional treatment.

The final phase of the study involves data analysis and dissemination of aggregated results. Surveys and questionnaires are used to assess participants.

Eligibility criteria: Inclusion Criteria:

* Major depressive episode
* Employed

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard Medical School
state: Massachusetts
Study officials:
References:
citation: Wang PS, Simon GE, Avorn J, Azocar F, Ludman EJ, McCulloch J, Petukhova MZ, Kessler RC. Telephone screening, outreach, and care management for depressed workers and impact on clinical and work productivity outcomes: a randomized controlled trial. JAMA. 2007 Sep 26;298(12):1401-11. doi: 10.1001/jama.298.12.1401.
Clinical trial NCT02933190: Fertility After Transvaginal Surgery or Uterine Artery Embolization Combined With Uterine Curettage in Patients With Cesarean Scar Pregnancy
Official title: Fertility After Transvaginal Surgery or Uterine Artery Embolization Combined With Uterine Curettage in Patients With Cesarean Scar Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Magnetic Resonance Imaging
Ovarian Function
Menstruation
Lead sponsor: Shanghai First Maternity and Infant Hospital
Sponsor class: OTHER
First posted: 2016-10-14
Enrollment: 50
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the fertility in patients after treatment by transvaginal surgery or uterine artery embolization combined with uterine curettage


Eligibility criteria: Inclusion Criteria:

* increased levels of serum β-hCG and ultrasonography findings. The criteria for diagnosis by ultrasonography was the presence of the following: (1) an empty uterine cavity and endocervical canal; (2) detection of the placenta and/or a gestational sac embedded in the hysterectomy scar; (3) the presence of the gestation sac with or without a fetal pole and with or without fetal cardiac activity (depending on the gestational age) in the anterior part of the uterine isthmus; and (4) a thin (1-3 mm) or absent myometrial layer between the gestational sac and the bladder(24). All patients had taken Magnetic Resonance Imaging (MRI) to clarify the diagnosis . Pregnancy tissues were identified by histopathology examinations of the surgical tissues.

Exclusion Criteria:

* All enrolled patients had no contraindications for transvaginal surgery or UAE, including renal failure, active pelvic infection, clotting disorders, or known allergy to the contrast material.

Primary outcomes:
measure: Duration of menstruation by questionnaire (days)
timeFrame: six months after treatment
measure: Endocrine level by blood examination (FSH in IU/L)
timeFrame: six months after treatment
measure: Volume of menstruation by questionnaire (in pictorial blood loss score)
timeFrame: six months after treatment
Secondary outcomes:
measure: The length of the CSD by MRI (millimeter)
timeFrame: six months after treatment
measure: The width of the CSD by MRI (millimeter)
timeFrame: six months after treatment
measure: The depth of the CSD by MRI (millimeter)
timeFrame: six months after treatment
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
state: Shanghai
Study officials:
affiliation: Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University
name: Xipeng Wang
role: STUDY_CHAIR
References:
Clinical trial NCT03382990: Stent Placement and the Risk of New-onset AF in Patients With AMI
Official title: The Impacts of Different Stent Types in Acute Myocardial Infarction on the Risk of Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation New Onset
Acute Myocardial Infarction
Keywords: Atrial fibrillation
Acute myocardial infarction
Drug-eluting stent
Lead sponsor: Mackay Memorial Hospital
Sponsor class: OTHER
First posted: 2017-12-26
Enrollment: 40000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Within the retrospective cohort, we include patients who had received a primary diagnosis of AMI based on the discharge claim between 2007 and 2013. After the exclusion by the mentioned criteria, patients with AMI treated with PCI and stent placement are intended to be analyzed in the present study.

Brief summary: The benefit of a drug-eluting stent (DES) in patients with acute myocardial infarction (AMI) is controversial. This study will aim to observe the effect of a DES on the risk of new-onset AF in patients with AMI.

Detailed description: Acute myocardial infarction (AMI) is the leading cause of mortality in the world. Early invasive strategy with percutaneous coronary intervention (PCI) has been demonstrated to be the most effective strategy to treat AMI. Although drug-eluting stent (DES) has not shown benefits to reduce mortality rate among AMI patients compared with bare-metal stent (BMS), the use of DES in real-world is increasing because of reduced restenosis rates. AMI patients are at higher risk to develop atrial fibrillation (AF) than general population. However, whether early PCI with DES implantation is related to a reduced risk of AF still remains unclear. The purpose of this study is to investigate the association of DES implantation and the risk of AF among patients with AMI treated by early PCI.

Eligibility criteria: Inclusion Criteria:

* Patients were enrolled by primary diagnostic coding as acute myocardial infarction and treatment coding as receiving PCI between 2007 and 2013 in Taiwan National Health Insurance Research Database (NHIRD)

Exclusion Criteria:

1. Less than 20-years-old; Unknown sex and age
2. Not residents in Taiwan
3. Died during AMI admission
4. Previous history of AF
5. Receiving coronary artery bypass grafting (CABG), ventricular assist device (VAD), extracorporeal membrane oxygenation (ECMO), and heart transplantation during observational and/or database period
6. No stent implantation during PCI
7. Unknown stent types

Primary outcomes:
measure: new-onset atrial fibrillation
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Taipei Medical University
name: Li-Nien Chien, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01024790: Exercise Study to Help Patients Who Have Type 2 Diabetes and Depression.
Official title: Behavioral Activation Enhanced Exercise Intervention:Pre-Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2009-12-03
Enrollment: 29
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test an exercise treatment that includes behavioral strategies to improve blood sugar control in women with type 2 diabetes who are depressed and overweight.This research study may lead to a potentially useful treatment for diabetes management when depression is present.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes, depression, BMI \<44,ages between 21-65, female

Exclusion Criteria:

* BMI \>44, \>100 min. of exercise per week, Type 1 diabetes, no diabetes,MI,Stroke, Catheterization, unstable angina in previous 6 months,pregnancy,glucocorticosteroid therapy in last 3 months,bipolar, psychotic disorder or post-traumatic disorder,moving out of area within next 6 weeks

Primary outcomes:
measure: This research study may lead to a potentially useful treatment for diabetes management when depression is present.
timeFrame: 6 weeks
measure: HbA1c
timeFrame: 3-,6-, and 9-months
measure: Depression
timeFrame: 3-, 6- and 9-months
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Medical School
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Kristin Schneider, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schneider KL, Pagoto SL, Handschin B, Panza E, Bakke S, Liu Q, Blendea M, Ockene IS, Ma Y. Design and methods for a pilot randomized clinical trial involving exercise and behavioral activation to treat comorbid type 2 diabetes and major depressive disorder. Ment Health Phys Act. 2011 Jun 1;4(1):13-21. doi: 10.1016/j.mhpa.2011.04.001.
Clinical trial NCT00543790: Study Evaluating PRA-027 Multiple Ascending Doses In Cycling And Postmenopausal Women
Official title: A Randomized, Placebo-Controlled, Double-Blind, Sponsor-Unblinded, Multiple-Dose Study Of The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of PRA-027 Administered Orally To Cycling Or Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Uterine Leiomyomata (Fibroids)
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-10-15
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is the first multiple-dose study in humans with PRA-027. This study will provide an assessment of the safety, tolerability, pharmacokinetics (how the drug is absorbed, metabolized and excreted by the body) and pharmacodynamics (a measure of whether the drug is active in the body) of PRA-027 after administration of 28 days of oral doses in women of childbearing potential (cycling) or postmenopausal women.


Eligibility criteria: Inclusion Criteria:

Inclusion Criteria - All Women

* Healthy, nonsmoker or smoker of fewer than 10 cigarettes (half a pack) per day and able to abstain from tobacco throughout all times when in the clinical facility.

Inclusion Criteria - Cycling Women

* Aged 18 to 45 years, must not be breastfeeding, pregnant, or have a recent (within 90 days before pretreatment period day 1) history of pregnancy, with a history of regular menstrual cycles (21 to 35 days in duration).

Inclusion Criteria - Postmenopausal Women

* Aged 35 to 65 years, menopause may be natural or due to surgery, natural amenorrhea must have begun by age of 55 years and have initiated at least 6 months before study day 1.

Exclusion Criteria:

* Women with hysterectomy or complex or simple ovarian cysts greater than 3 cm in diameter.
* History of drug abuse (within 6 months) or alcoholism (within 12 months).
* History of female infertility.

Primary outcomes:
measure: To assess the safety and tolerability of ascending, multiple, oral doses of PRA-027 in cycling and postmenopausal women.
timeFrame: 28 days
Secondary outcomes:
measure: To provide the PK and PD profile of multiple oral doses of PRA-027 in cycling and postmenopausal women.
timeFrame: 28 days
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04997590: Clinical Study of Umbilical Cord Blood Mononuclear Cells (UCB-MNCs) in the Treatment of Traumatic Fracture Healing
Official title: Clinical Study of Umbilical Cord Blood Mononuclear Cells (UCB-MNCs) in Promoting Traumatic Fracture Healing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Nonunion
Keywords: Umbilical cord blood mononuclear cells
Traumatic fracture healing
Bone nonunion
Lead sponsor: Qianfoshan Hospital
Sponsor class: OTHER
Collaborators: name: Shandong Qilu Stem Cells Engineering Co., Ltd.
First posted: 2021-08-09
Enrollment: 40
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: The aim of this study is to explore the effectiveness and safety of umbilical cord blood mononuclear cells in promoting traumatic fracture healing.

Detailed description: Umbilical cord blood mononuclear cells are a type of cell group containing hematopoietic stem cells, mesenchymal stem cells, neural stem cells, endothelial cells, immune cells, etc.In this study ,umbilical cord blood mononuclear cells will be used in promoting traumatic fracture healing,and the effectiveness and safety of the treatment plan was evaluated by twelve months of follow-up after treatment.

Eligibility criteria: Inclusion Criteria:

* Traumatic long bone fracture.
* Noninfectious bone nonunion, delayed bone union.
* 3 months after the operation of the fracture, the examination showed no callus growth, no signs of progressive repair at the fracture site, fracture piece space \< 5mm.
* No shortening, angulation and displacement.
* There was no obvious callus growth 8 months after local bone grafting.

Exclusion Criteria:

* There are infection foci at and near the fracture end after fracture.
* 3 months after the fracture, tests showed partial callus growth.
* Combining shortening, angulation and displacement phenomena.
* Partial callus grew 8 months after local bone grafting.

Primary outcomes:
measure: Bone formation
timeFrame: 1 month to 1 year after treatment
measure: Bone defect connection
timeFrame: 1 month to 1 year after treatment
measure: Bone reconstruction
timeFrame: 1 month to 1 year after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: China, Shandong Qianfoshan Hospital
state: Shandong
Study officials:
affiliation: Qianfoshan Hospital
name: Jing Liang, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04120090: Ruxolitinib as a Salvage Therapy for Hemophagocytic Lymphohistiocytosis
Official title: Clinical Study of Different Doses of Ruxolitinib as a Salvage Therapy for Refractory/Relapsed Hemophagocytic Lymphohistiocytosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hemophagocytic Lymphohistiocytosis
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aimed to investigate the efficacy and safety of different doses of ruxolitinib as a salvage therapy for refractory/relapsed hemophagocytic lymphohistiocytosis(HLH).


Eligibility criteria: Inclusion Criteria:

1. meet hemophagocytic lymphohistiocytosis (HLH)-04 diagnostic criteria;
2. treated with HLH-94 no less than 2 weeks before enrollment and did not achieve at least PR; or relapsed patients after remission；
3. Life expectancy exceeds 1 month;
4. Age≥1 year old and ≤75 years old, gender is not limited；
5. Before the start of the study, total bilirubin ≤ 10 times the upper limit of normal; serum creatinine ≤ 1.5 times normal；
6. Serum human immunodeficiency virus(HIV) antigen or antibody negative；
7. Hepatitis C virus (HCV) antibody is negative, or HCV antibody is positive, but HCV RNA is negative；
8. Both hepatitis B virus (HBV) surface antigen and HBV core antibody were negative. If any of the above is positive, peripheral blood hepatitis B virus DNA titer should be detected, and less than 1×103 copies/ml can enter the group；
9. Informed consent.

Exclusion Criteria:

1. Pregnancy or lactating Women；
2. Allergic to ruxolitinib；
3. Active bleeding of the internal organs；
4. uncontrollable infection；
5. Serious mental illness;
6. Non-melanoma skin cancer history;
7. Patients unable to comply during the trial and/or follow-up phase;
8. Participate in other clinical research at the same time.

Primary outcomes:
measure: Response rate
timeFrame: 1 years
measure: Progression Free Survival
timeFrame: 1 years
Secondary outcomes:
measure: Overall Survival
timeFrame: 1 years
measure: Adverse events
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
Study officials:
References:
Clinical trial NCT05277090: Bowel Preparation May Lead to a Higher Feasibility of Intestinal Infection
Official title: Bowel Preparation for Colonoscopy May Lead to a Higher Feasibility of Intestinal Infection: a Clinical and Basic Research
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Healthy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2022-03-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: An adequate bowel preparation is essential for a high quality of colonscopy. Nowdays, polyethyleneglyco is considered the most safe drug for bowel preparation, and is widely used around the world. However, previous study illustrated that bowel preparation by polyethyleneglyco could lead to qualitative changes in the intestinal microbiota both in mice and human. This study is aimed to investigate wether the changes in the intestinal microbiota could lead to a higher rate of intestinal infection.


Eligibility criteria: Inclusion Criteria:

* patients who agree to participant in the study

Exclusion Criteria:

* patients who couldn't stand polyethyleneglycol or inulin patients couldn't provide Informed consent patients who are suffering from sever heart disease, pulmonary disease or renal dysfunction.

Primary outcomes:
measure: Polyethyleneglycol could lead to changes in the intestinal flora
timeFrame: one year(from 15/3/2022 to 15/3/2023)
Secondary outcomes:
measure: inulin and probiotics could improve the recovery of gut microbiota
timeFrame: one year(from 15/3/2022 to 15/3/2023)
Other outcomes:
Locations:
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Guanjun Kou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04533503: Vis-Rx Post-Market Evaluation
Official title: Post-Market Clinical Evaluation of the Gentuity High-Frequency Optical Coherence Tomography Imaging System and Vis-Rx Micro-Imaging Catheter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: Gentuity, LLC
Sponsor class: INDUSTRY
First posted: 2020-08-31
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the cardiac catheterization lab who are candidates for transluminal interventional procedures

Brief summary: Post-market clinical evaluation of the Gentuity High-Frequency Optical Coherence Tomography (HF-OCT) System and the Vis-Rx Micro-Imaging Catheter for use in Percutaneous Coronary Intervention (PCI) procedures.

Detailed description: Prospective, single-arm, unblinded, multi-center, post-market clinical evaluation assessing the imaging capabilities of the Gentuity HF-OCT System and the Vis-Rx Micro-Imaging Catheter for use in PCI procedures. Objectives are to evaluate the clinical and technical performance in the target patient population.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Willing and able to provide written informed consent to participate
* Transluminal interventional procedure for their coronary arteries

General Exclusion Criteria:

* Bacteremia or sepsis
* Major coagulation system abnormalities
* Severe hemodynamic instability or shock
* Acute renal failure
* Disqualified for Coronary Artery Bypass Graft (CABG) surgery
* Disqualified for PCI procedure
* Currently enrolled in another study to evaluate an investigational device or medication

Lesion-Specific Exclusion Criteria:

* Total occlusion
* Coronary artery spasm
* Large thrombus (visible under angiography)
* Any target vessel which has undergone a bypass procedure

Primary outcomes:
measure: Clinical performance
timeFrame: Immediately after the procedure
measure: Technical performance
timeFrame: Up to 3 months following the procedure
Secondary outcomes:
measure: Complete pullbacks
timeFrame: Up to 3 months following the procedure
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
References: