louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01797289: Prevalence of Pulmonary Embolism in Patients With Syncope
Official title: The Prevalence of Pulmonarym Embolism in Patients With the First Episode of Syncope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Syncope
Pulmonary Embolism
Keywords: syncope
pulmonary embolism
Lead sponsor: University of Padova
Sponsor class: OTHER
First posted: 2013-02-22
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: All patients consecutively referred with the first episode of transient and short-lasting loss of consciousness will have a diagnostic workup for the assessment of the most common causes of syncope, and will be evaluated for the presence of pulmonary embolism (PE) with the use of an internationally accepted algorithm including a pre-test clinical probability (PTP according to the method of Wells et al.) and a high-sensitivity quantitative D-dimer assay. If the PTP is low and D-dimer negative, PE will be excluded. All other patients will undergo confirmatory diagnostic tests (either computerized tomography or ventilation/perfusion lung scanning) in order to confirm or rule out the presence of PE.


Eligibility criteria: Inclusion Criteria:

* first episode of syncope

Exclusion Criteria:

* previous episodes of syncope
* ongoing anticoagulation
* age younger than 18 years
* pregnancy

Primary outcomes:
measure: To assess the prevalence of PE in a large series of consecutive patients presenting with the first episode of syncope
timeFrame: Up to 48 hours after hospital admission
Secondary outcomes:
measure: To assess the prevalence of pulmonary embolism in patients with apparently unexplained syncope
timeFrame: Up to one week after hospital admission
Other outcomes:
measure: To assess the prevalence of pulmonary embolism in patients with syncope with a high pre-test probability of PE and/or a positive D-dimer
timeFrame: Up to 48 hours after admission
Locations:
city: Padua
country: Italy
facility: Clinica Medica 2 University of Padua
Study officials:
References:
citation: Prandoni P, Lensing AW, Prins MH, Ciammaichella M, Perlati M, Mumoli N, Bucherini E, Visona A, Bova C, Imberti D, Campostrini S, Barbar S; PESIT Investigators. Prevalence of Pulmonary Embolism among Patients Hospitalized for Syncope. N Engl J Med. 2016 Oct 20;375(16):1524-1531. doi: 10.1056/NEJMoa1602172.
Clinical trial NCT01886989: Cocoa Polyphenols and Postprandial Metabolism in Type 2 Diabetes
Official title: Postprandial Effects of Polyphenol-rich Cocoa Beverage on Glucose, Insulin, Lipids, Oxidative Stress and Inflammation in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Keywords: diabetes
cocoa polyphenols
postprandial glycemia
postprandial lipemia
Lead sponsor: Oklahoma State University
Sponsor class: OTHER
First posted: 2013-06-26
Enrollment: 18
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study aims to investigate the postprandial effects of cocoa supplementation in glucose and lipids, and surrogate markers of atherosclerosis in patients with type 2 diabetes. The investigators aim to test the hypothesis that cocoa will lower high-fat mixed meal breakfast-induced postprandial rise of glucose, lipids and markers of atherosclerosis in patients with diabetes. Randomized cross-over controlled trial, in which participants will be assigned to the placebo or cocoa group with breakfast meal. Patients with type 2 diabetes(n=25) will qualify for the study. The participants will be asked to consume 2 cups cocoa or placebo beverage on 2 separate postprandial study days. Both groups will receive high-fat mixed meal breakfast on each day. Blood draws and blood pressure (including HDI) measurements will be conducted at fasting, 30 min, 1,2, 4 \& 6 hours postprandial each day for 2 days.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of type 2diabetes

Exclusion Criteria:

* on insulin therapy

Primary outcomes:
measure: Blood pressure (mm Hg)
timeFrame: 2.5 years
Secondary outcomes:
measure: Glucose (mg/dL)
timeFrame: 2.5 years
measure: Blood lipids
timeFrame: 2.5 years
measure: Inflammation
timeFrame: 2.5 years
Other outcomes:
Locations:
city: Stillwater
country: United States
facility: Department of Nutritional Sciences
state: Oklahoma
Study officials:
affiliation: Oklahoma State University
name: ARPITA BASU, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davis DW, Tallent R, Navalta JW, Salazar A, Lyons TJ, Basu A. Effects of Acute Cocoa Supplementation on Postprandial Apolipoproteins, Lipoprotein Subclasses, and Inflammatory Biomarkers in Adults with Type 2 Diabetes after a High-Fat Meal. Nutrients. 2020 Jun 27;12(7):1902. doi: 10.3390/nu12071902.
citation: Basu A, Betts NM, Leyva MJ, Fu D, Aston CE, Lyons TJ. Acute Cocoa Supplementation Increases Postprandial HDL Cholesterol and Insulin in Obese Adults with Type 2 Diabetes after Consumption of a High-Fat Breakfast. J Nutr. 2015 Oct;145(10):2325-32. doi: 10.3945/jn.115.215772. Epub 2015 Sep 2.
Clinical trial NCT01873989: Testosterone Replacement for Male Opioid Agonist Maintained Patients
Official title: Testosterone Replacement for Male Opioid Agonist Maintained Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Pain
Opioid Addiction
Symptomatic Hypogonadism
Keywords: Chronic pain
Opioid addiction
Symptomatic hypogonadism
Testosterone replacement
Opioid agonist maintenance
Methadone
Buprenorphine
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2013-06-10
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to develop an effective treatment intervention for chronic pain, symptomatic hypogonadism, and opioid addiction

Detailed description: This study aims to assess the initial efficacy of testosterone replacement in male opioid agonist patients with symptomatic hypogonadism and chronic pain.

The study has two specific aims:

1. To estimate, in male opioid agonist maintained patients, the prevalence of (a)symptomatic hypogonadism and (b) co-occurring symptomatic hypogonadism and chronic pain.
2. To conduct a pilot randomized clinical trial to obtain data regarding the feasibility, acceptability, and efficacy (compared to waitlist control) of testosterone replacement for male patients with chronic pain and opioid dependence, and symptomatic hypogonadism treated with opioid agonist maintenance treatment (N=40).

Eligibility criteria: Inclusion Criteria:

* Between 18 and 50 years of age
* Male buprenorphine- or methadone-maintained patients at the APT Foundation
* Moderate to severe chronic pain
* Meet criteria for symptomatic hypogonadism
* Understand English
* Interested in receiving testosterone replacement

Exclusion Criteria:

* Current suicide or homicide risk
* Life-threatening or unstable medical condition
* Known or suspected prostate or chest cancer or history of polycythemia

Primary outcomes:
measure: Number of Participants Demonstrating Abstinence
timeFrame: 8 weeks
measure: Change in Pain Ratings
timeFrame: 8 weeks
measure: Change in Sexual Dysfunction From Baseline to Week 8
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: MRU, APT Foundation, Inc
state: Connecticut
Study officials:
affiliation: Yale University
name: Christopher J Cutter, Ph.D.
role: STUDY_DIRECTOR
affiliation: Yale University
name: Declan T Barry, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00986089: Intrauterine Device (IUD) Placement at the Time of Cesarean Section
Official title: Pilot Study of Copper IUD Placement at the Time of Cesarean Section
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Intrauterine Device Placement
Keywords: post-placental
IUD
Copper IUD
cesarean section
immediate post-partum
continuation
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: Duramed Research
First posted: 2009-09-29
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women ages 18-40 who are undergoing a scheduled cesarean section, or women who are attempting to VBAC and want an IUD post partum will be eligible.

Brief summary: To evaluate the continuation of the Copper IUD at one year after placement through the cesarean incision into the uterus at the time of cesarean section.


Eligibility criteria: Inclusion Criteria:

* Desire an IUD post-partum and are willing to use the copper IUD.
* They will also need to be patients at one of our OBGYN clinics at the university of Kentucky.

Exclusion Criteria:

* Post-partum hemorrhage,
* Chorioamnionitis (or a fever \>101 at the time of cesarean),
* Women on antibiotic or immunosuppressive therapies,
* Cervical dilation \> 5 cm at the time of c-section, OR
* Excessive intraoperative blood loss.
* Also women with contraindications to a copper IUD: Wilson's disease, unusual uterine shape or known uterine anomaly.

Primary outcomes:
measure: Continuation at one year
timeFrame: 1 year
Secondary outcomes:
measure: satisfaction with placement at time of cesarean
timeFrame: 4-6 months and 1 year
measure: bleeding profile
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
citation: Hayes JL, Cwiak C, Goedken P, Zieman M. A pilot clinical trial of ultrasound-guided postplacental insertion of a levonorgestrel intrauterine device. Contraception. 2007 Oct;76(4):292-6. doi: 10.1016/j.contraception.2007.06.003. Epub 2007 Aug 6.
citation: Liu BH, Zhang LY, Zhang BR. Intrauterine contraceptive device insertion with suture fixation at cesarean section. Chin Med J (Engl). 1983 Feb;96(2):141-4.
citation: Eroglu K, Akkuzu G, Vural G, Dilbaz B, Akin A, Taskin L, Haberal A. Comparison of efficacy and complications of IUD insertion in immediate postplacental/early postpartum period with interval period: 1 year follow-up. Contraception. 2006 Nov;74(5):376-81. doi: 10.1016/j.contraception.2006.07.003. Epub 2006 Sep 15.
Clinical trial NCT01993589: Effect of Paracetamol, Dexketoprofen Trometamol, Lidocaine Spray, Pethidine and Diclofenac Sodium Application for Pain Relief During Fractional Curettage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain and Curettage
Keywords: Curettage; analgesia; paracetamol; lidocaine; Dexketoprofen trometamol; pethidine; diclofenac.
Lead sponsor: Kayseri Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2013-11-25
Enrollment: 144
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients frequently experience pain from moderate to severe during gynecologic procedures. This study is a prospective, randomized, placebo-controlled trial and aimed to investigate the analgesic efficacy of preoperative oral dexketoprofen trometamol, intravenous paracetamol, lidocaine spray, pethidine and diclofenac sodium on fractional curettage procedure.

Detailed description: A total of 144 mutiparous subjects randomly allocated one of six groups. The first group (control group) consisted of 22 participants and they did not receive any treatment. The second group consisted of 26 participants receiving oral 25 mg dexketoprofen trometamol. The third group consisted of 23 participants receiving 2 puff lidocaine sprays on cervical mucosa. The forth group consisted of 25 participants receiving 100 mg pethidine. The fifth group consisted of 23 participants receiving 1000 mg intravenous paracetamol and the sixth group consisted of 25 participants receiving diclofenac sodium.

Eligibility criteria: Inclusion Criteria:

* multiparous participants
* abnormal uterine bleeding
* postmenopausal bleeding
* myoma uteri causing menometrorrhagia
* cervical polyp
* tamoxifen treatment for breast cancer
* adnexial mass

Exclusion Criteria:

* abortions
* pregnancy
* primiparity
* diabetes mellitus
* tendency to bleed such as thrombocytopenia
* factor deficiency
* functional disorders of platelets

Primary outcomes:
measure: Pain
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Kayseri Education and Research Hospital of Medicine
Study officials:
References:
citation: Acmaz G, Bayraktar E, Aksoy H, Baser M, Yilmaz MO, Muderris II. Effect of paracetamol, dexketoprofen trometamol, lidocaine spray, pethidine & diclofenac sodium application for pain relief during fractional curettage: A randomized controlled trial. Indian J Med Res. 2015 Oct;142(4):399-404. doi: 10.4103/0971-5916.169197.
Clinical trial NCT03814889: Passive Tactile Stimulation for Stroke Rehabilitation
Official title: Passive Tactile Stimulation for Stroke Rehabilitation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Stroke, Ischemic
Stroke Hemorrhagic
Spasticity as Sequela of Stroke
Keywords: spasticity
tone
hemiplegia
hemiparesis
arm
hand
vibration
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2019-01-24
Enrollment: 35
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: Stroke can lead to weakness and spasticity in the arm or hand. The purpose of this study is to optimize the design of gentle vibratory stimulation delivered to the hands of individuals with chronic stroke, and explore the effect on range of movement and spasticity.


Eligibility criteria: Inclusion Criteria:

* Age 18 and older.
* diagnosis of stroke with upper extremity spasticity or other movement deficits that affect strength and range of movement.
* willing to participate in the vibrotactile stimulation sessions for consecutive days and willing to return for follow up visits as needed for the PHASE in progress.
* able to provide informed consent.

Exclusion Criteria:

* Patients with severe contracture that precludes Modified Ashworth Score (MAS) testing.

Primary outcomes:
measure: Change in Modified Ashworth at 12 Weeks
timeFrame: Change from Baseline Modified Ashworth at 12 weeks
measure: Change in Modified Ashworth at 8 Weeks
timeFrame: Change from Baseline Modified Ashworth at 8 weeks
measure: Change in Range of Motion at 8 Weeks
timeFrame: Change from Baseline Range of Motion at 8 weeks
measure: Change in Range of Motion at 12 Weeks
timeFrame: Change from Baseline Range of Motion at 12 weeks
measure: Change in Modified Ashworth During Stimulation (Pattern 1).
timeFrame: 20 minutes after stimulation start
measure: Change in Modified Ashworth During Stimulation (Pattern 2).
timeFrame: 20 minutes after stimulation start
measure: Change in Modified Ashworth During Stimulation (Pattern 3).
timeFrame: 20 minutes after stimulation start
measure: Change in Modified Ashworth During Stimulation (Sham Control).
timeFrame: 20 minutes after stimulation start
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford Neuroscience Health Center
state: California
Study officials:
affiliation: Stanford University
name: Allison M Okamura, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00477789: Effects of Allopurinol on Diastolic Function in Chronic Heart Failure Patients
Official title: Effects of Allopurinol on Diastolic Function in Chronic Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Heart Failure
Keywords: chronic heart failure
diastolic dysfunction
uric acid
Lead sponsor: Universita di Verona
Sponsor class: OTHER
First posted: 2007-05-24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In patients with chronic heart failure (CHF)due to dilated cardiomyopathy diastolic dysfunction occurs frequently and is related to a poor outcome. We have previously shown that parameters of diastolic function significantly correlate with uric acid levels, a marker of impaired oxidative metabolism. We aimed to determine whether inhibition of xanthine oxidase with allopurinol might affect diastolic function in patients with CHF.


Eligibility criteria: Inclusion Criteria:

* chronic heart failure;
* left ventricular systolic dysfunction (ejection fraction \<45%)
* stable clinical conditions in the previous three months
* optimal medical therapy for CHF
* normal sinus rhythm
* written informed consent
* age \>18 years

Exclusion Criteria:

* renal failure (s-creatinine \>2.5 mg/dl)
* already on allopurinol
* malignancies
* chronic inflammatory diseases

Primary outcomes:
measure: diastolic function uric acid levels BNP
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Verona
country: Italy
facility: Division of Cardiology, University Hospital of Verona
Study officials:
affiliation: Division of Cardiology, University of Verona, Italy
name: Mariantonietta Cicoira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00414089: Efficacy and Safety of Treatment With a Single Dose of 90Y-ibritumomab Tiuxetan in Patients With Low Tumor Burden Untreated or Indolent NHL
Official title: Efficacy and Safety of Treatment With a Single Dose of 90Y-ibritumomab Tiuxetan in Patients With Previously Untreated Low Tumor Burden Indolent Non-Hodgkin's Lymphoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Lymphoma
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
First posted: 2006-12-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see how well Zevalin works in the treatment of low grade indolent B-cell lymphoma when given to patients who have not had any previous treatment for their lymphoma and who otherwise would be followed on a "watch \& wait" policy.


Eligibility criteria: Inclusion Criteria:

* histologically confirmed indolent lymphoma including:

  * follicular grade 1 or 2
  * small lymphocytic
  * marginal zone (nodal)
  * marginal zone (splenic)
  * mucosa associated lymphoid tissue (MALT)
* no evidence of transformation
* Stage III or IV disease
* No prior therapy
* involvement by less than 25% of bone marrow on assessment of trephine biopsy
* absolute lymphocyte count ≤ x 109/L
* platelets ≥ 150 x 109/L
* hemoglobin ≥ 100g/L
* absolute neutrophil count ≥ 1.5 x 109/L
* at least one bidimensionally measurable lesion at least 2cm by CT scanning

Exclusion Criteria:

* any other anticancer treatment for NHL
* prior radiation therapy
* prior myeloablative therapy (bone marrow or peripheral blood stem cell transplant)
* no other malignancy within the past 10 years except adequately treated non-melanoma skin tumors or carcinoma in situ of the cervix
* presence of central nervous system lymphoma
* patients known to be HIV positive
* patients with known seropositivity for Hepatitis C virus, Hepatitis B virus or other active infection uncontrolled by treatment
* patients with abnormal liver function: total bilirubin \> 1.5X ULN or ALT \> 2.5X ULN
* patients with abnormal renal function: serum creatinine \> 2.5X ULN
* known hypersensitivity to murine antibodies or proteins
* immunotherapy during the preceding 6 months (including monoclonal antibodies, interleukins, interferon)

Primary outcomes:
measure: Response
Secondary outcomes:
measure: Progression free survival
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Andrew Belch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03374189: Prospective Study on a Novel Port-site Closure Device (EZ Close): Effectiveness and Comparison With Carter-Thomason
Official title: Single Blind Randomized Control Trial Evaluating Efficacy and Safety of EZ-Close Port-site Closure Device Versus Carter-Thomason Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Port Site Hernia
Lead sponsor: Saint Vincent's Hospital, Korea
Sponsor class: OTHER
First posted: 2017-12-15
Enrollment: 79
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to evaluate the efficacy and safety of a novel port-site closure device (EZ Close) by comparing it with the Carter-Thomason device.

Detailed description: Port-site closure is a critical procedure after every laparoscopic surgery. Complications such as visceral organ injury, port-site hernia, infection, ascitic fluid leakage may occur during and after the procedure. Many devices were developed and utilized for the procedure and Carter-Thomason is one of the most commonly used device and validated with several studies. This study aims to evaluate the efficacy and safety of a novel port-site closure device (EZ Close) by comparing it with the Carter-Thomason device.

Eligibility criteria: Inclusion Criteria:

* All patients with laparoscopic ports over 10mm

Exclusion Criteria:

* Patients with laparoscopic ports under 10mm
* Patients who refused the study
* Patients who received concurrent surgery for other reason

Primary outcomes:
measure: Time Taken to Complete Closure
timeFrame: At the time of surgery
Secondary outcomes:
measure: Number of Participants With Visceral Organ Injury
timeFrame: At the time of surgery
measure: Number of Participants With Need for Additional Instrument
timeFrame: At the time of surgery
measure: Number of Participants With Port-site Hernia
timeFrame: 3 days post-op and within one months of surgery
measure: Number of Participants With Port-site Infection
timeFrame: 3 days post-op and within one months of surgery
measure: Number of Participants With Ascitic Fluid Leakage
timeFrame: 3 days post-op and within one months of surgery
measure: Number of Participants With Wound Dehiscence
timeFrame: 3 days post-op and within one months of surgery
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: St. Vincent's Hospital
Study officials:
affiliation: St Vincent's Hospital
name: Hee Youn Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: del Junco M, Okhunov Z, Juncal S, Yoon R, Landman J. Evaluation of a novel trocar-site closure and comparison with a standard Carter-Thomason closure device. J Endourol. 2014 Jul;28(7):814-8. doi: 10.1089/end.2014.0069. Epub 2014 Apr 23.
citation: Shetty A, Adiyat KT. Comparison between hand suture and Carter-Thomason needle closure of port sites in laparoscopy. Urol J. 2014 Sep 2;11(4):1768-71.