louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04740619: Natural Orifice Specimen Extraction in Sigmoid Volvulus
Official title: Natural Orifice Specimen Extraction in Sigmoid Volvulus Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mortality
Morbidity
Keywords: colon
volvulus
natural orifice
laparoscopy
sigmoid
Lead sponsor: Dr. Ersin Arslan Education and Training Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Inonu University
First posted: 2021-02-05
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: sigmoid volvulus patients

Brief summary: Sigmoid resection can be performed using conventional and laparoscopic methods. There are few publications in the literature reporting specimen removal from the natural hole in patients with a diagnosis of sigmoid volvulus. Here, the investigators aimed to present the literature that transanal specimen removal is a technically feasible method after laparoscopic surgery in patients with sigmoid volvulus.

Detailed description: Sigmoid resection can be performed using conventional and laparoscopic methods. There are few publications in the literature reporting specimen removal from the natural hole in patients with a diagnosis of sigmoid volvulus. Here, the investigators aimed to present the literature that transanal specimen removal is a technically feasible method after laparoscopic surgery in patients with sigmoid volvulus. The documents of patients who were operated on for sigmoid volvulus between 2018 and 2019 were retrospectively reviewed. Patients who had been used transanal for specimen extraction by elective laparoscopic sigmoid colon resection were included in the study. Patients' gender, age, comorbidity, operation time, operative difficulties, complications, length of stay, and mortality findings were analyzed. Laparoscopic sigmoid resection and transanal specimen removal were performed in eight patients. Specimen extraction surgery from the natural hole is increasingly preferred. the investigators think that natural hole surgery can be performed more easily and reliably in sigmoid volvulus due to the large diameter of the colon.

Eligibility criteria: Inclusion Criteria:

* transanal for specimen extraction by elective laparoscopic sigmoid colon resection

Exclusion Criteria:

* emergency surgery
* conventional open sigmoid resection
* conventional laparoscopic sigmoid resection

Primary outcomes:
measure: mortality
timeFrame: 1 year
measure: morbidity
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Dr. Ersin Arslan Training and Resource Hospital
Study officials:
References:
Clinical trial NCT01026519: A Safety and Tolerability Study of REGN88(SAR153191) in Subjects With Rheumatoid Arthritis
Official title: A Single-dose, Double-Blind, Placebo-Controlled, Parallel Group Safety, Tolerability and Pharmacodynamic Study of Subcutaneous REGN88 in Subjects With Rheumatoid Arthritis Receiving Concomitant Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2009-12-04
Enrollment: 32
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 is a single-dose, double-blind, placebo-controlled, parallel group safety, tolerability and pharmacodynamic study of subcutaneously (SC) administered REGN88 in rheumatoid arthritis patients who are receiving concomitant methotrexate. Four (4) parallel groups of 8 subjects each with active rheumatoid arthritis will be dosed SC.


Eligibility criteria: Inclusion Criteria:

1. Male or female ≥18 years of age
2. Subjects must weigh \>50 and \<100 kg
3. Diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) criteria with disease duration of no less than 6 months and ACR class I-III

Exclusion Criteria:

1. A history of Listeriosis or active tuberculosis (TB)
2. Persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the Screening Visit
3. History of prior articular or prosthetic joint infection
4. History of a hypersensitivity reaction, other than localized injection site reaction (ISR), to any biological molecule
5. Significant concomitant illness such as, but not limited to cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease that would adversely affect the subject's participation in this study

Primary outcomes:
measure: hs-C reactive protein (hs-CRP)
timeFrame: 43 Days
Secondary outcomes:
measure: Subject's Assessment of Pain and Subject's Global Assessment of Disease activity
timeFrame: 43 Days
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Institute of Rheumatology under the Russian Academy of Medical Sciences
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Allen Radin, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06773819: A Study on the Pathogenesis and Determinants of Intravenous Leiomyomatosis
Official title: A Study on the Pathogenesis and Determinants of Intravenous Leiomyomatosis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Intravenous Leiomyomatosis
HPV Infection
Keywords: Intravenous leiomyomatosis
HPV
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult female patients with suspected IVL

Brief summary: The goal of this observational study is to learn about the impact of HPV infection in women with intravenous leiomyomatosis(IVL). The main question it aims to answer is:

Does HPV infection promote the development of IVL from uterine leiomyoma? Surgical sections and HPV-DNA test results will be collected in participants diagnosed with IVL or uterine leiomyoma.

Detailed description: Previous proteomic studies have demonstrated that HPV infection-related proteins are more highly expressed in intravenous leiomyomatosis (IVL) compared to uterine leiomyoma (uML). Consequently, we conducted a case-control study to investigate the association between HPV and the development of IVL. We recruited adult patients diagnosed with either IVL or uML, collected their medical histories, surgical specimens from various sites, and HPV-DNA test results from cervical exfoliated cells, and performed subsequent statistical analyses and mechanistic investigations.

Eligibility criteria: Inclusion Criteria:

* Adult female patients with suspected IVL or uterine leiomyoma who receive surgery at PUMCH
* Be able to understand and sign the informed consent

Exclusion Criteria:

* Patients with other concurrent malignant tumors
* Pregnant or lactating female
* Postoperative pathology do not include IVL or uterine leiomyoma

Primary outcomes:
measure: HPV-DNA test result
timeFrame: From date of enrollment until the date of surgery at PUMCH or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01828619: Study of New RIC Regimen of BuFlu in Older and/or Intolerable Patients
Official title: The Study of New RIC Regimen of BuFlu in Older or Intolerable Patients With Hematologic Malignant Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Leukemia
Myelodysplastic Syndrome
Keywords: Hematopoietic Stem Cell Transplantation
Busulfan
Fludarabine
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2013-04-10
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is patients with hematologic malignant diseases, who will undergo HLA matched HSCT.

Brief summary: The purpose of this study is to determine whether the new RIC regimen, containing of low dose of Bu (9.6mg/kg)and fludarabine without ATG, is suitable and effective in treating aged and/or intolerable patients with hematologic malignant disease, who undergoes allogenic stem cell transplantation.


Eligibility criteria: Inclusion Criteria:

* diagnosed of hematologic malignant disease
* will undergo HLA matced HSCT
* age \>=55years
* \<55year and intolerable to standard myeloablative conditioning

Exclusion Criteria:

* KPS status \<70
* cardiac EF\<50%
* creatine clearance \<50 ml/min
* ALT more than 10 times of upper normal limit

Primary outcomes:
measure: stem cell engraftment
timeFrame: 30day post transplantation
Secondary outcomes:
measure: toxicity and treatment related mortality
timeFrame: 100day and 1 year post transplantation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
Study officials:
affiliation: Peking University People's Hospital, Department of Hematology
name: XiaoJun Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barrett AJ, Savani BN. Stem cell transplantation with reduced-intensity conditioning regimens: a review of ten years experience with new transplant concepts and new therapeutic agents. Leukemia. 2006 Oct;20(10):1661-72. doi: 10.1038/sj.leu.2404334. Epub 2006 Jul 27.
citation: de Lima M, Couriel D, Thall PF, Wang X, Madden T, Jones R, Shpall EJ, Shahjahan M, Pierre B, Giralt S, Korbling M, Russell JA, Champlin RE, Andersson BS. Once-daily intravenous busulfan and fludarabine: clinical and pharmacokinetic results of a myeloablative, reduced-toxicity conditioning regimen for allogeneic stem cell transplantation in AML and MDS. Blood. 2004 Aug 1;104(3):857-64. doi: 10.1182/blood-2004-02-0414. Epub 2004 Apr 8.
Clinical trial NCT01472419: Prognostic Factor Analysis in Metastatic Esophageal Squamous Cell Carcinoma
Official title: Fluoropyrimidine/Platinum-based First-line Chemotherapy in Metastatic Esophageal Squamous Cell Carcinoma: Prognostic Factor Analysis in 239 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Esophageal Squamous Cell Carcinoma
Keywords: metastatic esophageal squamous cell carcinoma
Fluoropyrimidine/platinum-based first-line chemotherapy
prognosis
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-11-16
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Between January 2000 to December 2010, 239 patients were diagnosed of recurrent, metastatic esophageal SCC and received either FP or XP as first-line chemotherapy.

Brief summary: Esophageal squamous cell carcinoma is considerably more prevalent in East Asia. Despite of relatively high prevalence of esophageal SCC, prognosis is very poor with limited options of effective chemotherapy regimens. We attempted to identify favorable subgroups of patient who are likely to benefit from 5- fluorouracil/cisplatin(FP) or capecitabine/cisplatin (XP) chemotherapy as first-line treatment.Between January 2000 to December 2010, 239 patients were diagnosed of recurrent, metastatic esophageal SCC and received either FP or XP as first-line chemotherapy. Clinicopathologic variables and treatment outcome were retrospectively collected. we analysis treatment outcome of palliative chemotherapy in metastatic esophageal squamous cell carcinoma and make prognostic scoring system. The present study represents the largest series to analyze the treatment outcome of FP/XP chemotherapy in metastatic SCC. Risk-adapted stratification of treatment for subgroup of metastatic SCC patients should be actively pursued.


Eligibility criteria: Inclusion Criteria:

* recurrent, metastatic esophageal SCC
* received either FP or XP as first-line chemotherapy.

Exclusion Criteria:

Primary outcomes:
measure: Overall Survival
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Samsung Medical Center, Seoul, Korea
name: Jeeyun Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00732719: Compression Device Safety Study on Edema
Official title: A Phase II Non-Comparative Study Evaluating the Effects of the Compression Test Device on Oedema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Edema
Lead sponsor: ConvaTec Inc.
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2008-08-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To evaluate the safety of the prototype Compression Device in subjects with Oedema


Eligibility criteria: Inclusion Criteria:

* Subjects aged between 18 and 80, willing and able to provide written informed consent, and able to wear the device and follow the requirements of the protocol
* Subjects who have an ankle to brachial pressure index (ABPI) of at least 0.8.
* Subjects who suffer from chronic oedema (i.e. CEAP classification of C3, C4 or C5 1.)
* Subjects who have Chronic Venous Insufficiency (CVI), which has been present for 6 weeks or longer and who have refluxes \>0.5 sec in one or more major venous segments, superficial or deep or both (CEAP classification: C3-C5 1.; Ep,s; As,d; Pr).

Exclusion Criteria:

* Subjects with a history of skin sensitivity to any of the components of the study product.
* Subjects who have previously been entered into the study before
* Subjects who have a history of Deep Vein Thrombosis (DVT) within the last 6 months
* Subjects who have an active leg ulcer (i.e. CEAP classification of C6 1).
* Subjects with active cardiac disease or significant history of cardiac disease (including history of myocardial infarction, heart failure, valvular disease, arrhythmia and those with a pacemaker or have previously had a pacemaker).
* Subjects who have initiated treatment or changed the dose within the past month of pharmaceutical agents that reduce clotting e.g. aspirin (except low-dose aspirin), anti-platelets, anti-coagulants and coumarin.
* Subjects who are currently taking pharmaceutical agents that can modify the amount of leg oedema (e.g., diuretics, dihydropyridine calcium channel blockers, phlebotonic drugs, or fluctuating doses of systemic steroids) or have taken these agents within the last 10 days.
* Subjects who are pregnant
* Subjects who have worn compression therapy in the last 48 hours

Primary outcomes:
measure: The nature and incidence of adverse events
measure: Volume reduction
measure: Oedema reduction
Secondary outcomes:
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Hautarzt Phlebologe Allergologe
Study officials:
affiliation: Hautarzt Phlebologe Allergologe
name: Wolfgang Vanscheidt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01971619: Association of Vitamin D, Parathyroid Hormone and Fibroblast Growth Factor-23 With Infarction-related Arrhythmia in Patients With Acute Myocardial Infarction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myocardial Infarction
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-10-29
Enrollment: 510
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with acute myocardial infarction

Brief summary: To investigate the effect of vitamin D deficiency on the development of arrhythmia in patients with acute myocardial infarction.


Eligibility criteria: Inclusion Criteria:

* age ≥20 years
* diagnosed with acute myocardial infarction (confirmed by cardiac enzyme and EKG)
* subjects who agreed with informed consent

Exclusion Criteria:

* previous history of arrhythmia before onset of acute myocardial infarction
* currently taking anti-arrhythmic drugs
* severe condition of comorbid diseases that can cause more serious effects on patients than acute myocardial infarction does (e.g., cancer, cerebrovascular diseases, acute bleeding etc.)

Primary outcomes:
measure: Events of acute myocardial infarction-associated arrhythmia
timeFrame: first 48 hours after onset of acute myocardial infarction
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Internal Medicine, Yonsei University College of Medicine
Study officials:
References:
citation: Rienstra M, Cheng S, Larson MG, McCabe EL, Booth SL, Jacques PF, Lubitz SA, Yin X, Levy D, Magnani JW, Ellinor PT, Benjamin EJ, Wang TJ. Vitamin D status is not related to development of atrial fibrillation in the community. Am Heart J. 2011 Sep;162(3):538-41. doi: 10.1016/j.ahj.2011.06.013. Epub 2011 Aug 11.
Clinical trial NCT01296919: The Clinical Significance of the Uncinate Process Histopathology in Chronic Rhinosinusitis
Official title: New Insights on the Clinical Significance of the Uncinate Process Histopathology in Patients With Chronic Rhinosinusitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rhinosinusitis
Keywords: Chronic rhinosinusitis
Histopathology
Infundibulum
Lamina propria
Uncinate process
Lead sponsor: Assuta Hospital Systems
Sponsor class: OTHER
First posted: 2011-02-16
Enrollment: 30
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: Patients with chronic rhinosinusitis whose uncinate process had to be removed to enable surgical access to the sinuses.

Brief summary: Given that the uncinate process is the gatekeeper of the sinuses, we hypothesize that inflammation of the uncinate process is associated with decreased ventilation and drainage of the paranasal sinuses and consequently with the inflammatory process occuring in the sinuses.

Detailed description: The purpose of the present study is to gain insight into the histopathological changes of the uncinate process in patients with chronic rhinosinusitis through comparison of its mucosal and bony elements with those of the normal uncinate process without chronic inflammation (unpublished data: Gilead Berger, Ephraim Eviatar, Tatiana Kogan, Roee Landsberg).

Eligibility criteria: Inclusion Criteria:

Patients with chronic rhinosinusitis who:

* Failed conservative medical treatment.
* Stopped treatment (topical or systemic corticosteroids) at least two months before endoscopic sinus surgery.
* Had a Lund-MacKay CT score of 2 and higher of 24 available.

Exclusion Criteria:

* Immunosuppressed patients.
* Patients in whom a pathologic evaluation of the middle turbinate was necessary (e.g., suspected neoplastic disorder).
* Patients with a Lund-MacKay CT score \< 2 of 24 available.
* Pregnant women.
* Patients who underwent prior endoscopic sinus surgery.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: AssutaHS
Study officials:
affiliation: AssutaHS, Meir Medical Center
name: Gilead Berger, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assuta Hospital Systems
name: Eitan Yaniv, MD
role: STUDY_CHAIR
affiliation: Assuta Hospital Systems
name: Roee Landsberg, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01952119: Effect of a Secure Message Reminder on Hypertension Follow-up at an Integrated Health Care System
Official title: Effect of a Secure Message Reminder on Hypertension Follow-up at an Integrated Health Care Delivery System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: hypertension
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2013-09-27
Enrollment: 182
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: HEALTH_SERVICES_RESEARCH

Brief summary: This study will assess whether adding a secure message reminder to routine care improves the percentage of patients who complete a follow-up appointment with a new, documented blood pressure reading.

Detailed description: Hypertension is one of the leading risk factors for cardiovascular disease. Optimizing blood pressure management can help prevent adverse cardiovascular outcomes. The National Committee for Quality Assurance (NCQA) defines blood pressure control as less than 140/90 mmHg. Per this definition, less than half of Americans with hypertension are considered controlled. Literature has been published describing several ways of improving blood pressure management, but results have been variable.

Eligibility criteria: Inclusion Criteria:

* Member of Kaiser Permanente Georgia Pharmacy Cardiac Risk Service (PCRS)
* 18-75 years of age
* Enrolled in http://kp.org
* Most recent documented blood pressure is greater than or equal to 140/90 mmHg

Exclusion Criteria:

* Most recent documented blood pressure is greater than or equal to 180/110 mmHg

Primary outcomes:
measure: Appointment with new blood pressure reading
timeFrame: 6 weeks
Secondary outcomes:
measure: New appointment with new blood pressure reading
timeFrame: 6 weeks
measure: Existing appointment kept with new blood pressure reading
timeFrame: 6 weeks
measure: Change in antihypertensive regimen
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Kaiser Permanente Georgia
state: Georgia
Study officials:
affiliation: Kaiser Permanente Georgia
name: Alina Kuo, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Glynn LG, Murphy AW, Smith SM, Schroeder K, Fahey T. Interventions used to improve control of blood pressure in patients with hypertension. Cochrane Database Syst Rev. 2010 Mar 17;(3):CD005182. doi: 10.1002/14651858.CD005182.pub4.