louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05464901: VTE and the Related Factors Associated With Higher Rates of PE After a DVT in Southwestern China
Official title: The Real-World Treatment Status of Venous Thromboembolism and the Related Factors Associated With Higher Rates of PE After a DVT in Southwestern China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolism; Anticoagulants
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In the patients' characteristics, the hypertensive disorders of pregnancy were defined and classified into (a) hypertension known before pregnancy or present in the first 20 weeks and (b) hypertension arising de novo at or after 20 weeks on the basis of the International Society for the Study of Hypertension in Pregnancy Classification, Diagnosis, and Management Recommendations for International Practice

Brief summary: Little is known about the current management status of venous thromboembolism (VTE) in Southwestern China. We aimed to investigate the status of anticoagulant administration in VTE in Southwestern China and assess the potential predictors of deep vein thrombosis (DVT) complicated pulmonary embolism (PE). We extracted data from YiduCloud database from December 2006 to November 2018 and performed a cross-sectional survey of VTE. The demographics, laboratory tests, and anticoagulants were collected and analyzed in the logistic regression model, classification tree and Random Forest model.

Detailed description: We established a collaborative epidemiological work of southwestern China for our cross-sectional survey sample, which included hospitalized patients in the seven main medical centers who met the inclusion criteria. The Human Research Committee of Chongqing Medical University approved this study and waived the need for informed consent. Patients were eligible to be included in the study if they are admitted or discharged with a diagnosis of DVT or/and PE and if they ever received treatment in the seven medical centers between December 2006 to November 2018.

Eligibility criteria: Inclusion Criteria:

- In the Chinese VTE guidelines, the diagnosis of VTE depends on a series of tests. D-dimer was used to screen for thrombosis, and limb venous ultrasound was used to diagnose DVT. CT pulmonary angiography (CTPA) or pulmonary ventilation perfusion scan was used for the diagnosis of pulmonary embolism. Through the retrieval of patient diagnosis in the database, we retrieved the basic data of all patients diagnosed as VTE during the study period.

Exclusion Criteria:

-

Primary outcomes:
measure: The maternal cardiac events and the neonatal complications
timeFrame: 2010-2019
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03251001: Acellular Dermal Matrix Allograft Versus Free Gingival Graft
Official title: Acellular Dermal Matrix Allograft Versus Free Gingival Graft: a Histological Evaluation and Split-mouth Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingiva Atrophy
Gingivitis
Keywords: gingiva
keratinized mucosa
gingival graft
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split-mouth design. One side of mouth was test group, other side was control group.
Primary purpose: TREATMENT

Brief summary: The present split-mouth controlled randomized clinical trial aimed to evaluate clinical and histological results of acellular dermal matrix allograft (ADM) compared to autogenous free gingival graft (FGG)


Eligibility criteria: Inclusion Criteria:

* absence or deficiency of keratinized tissue (\< 1mm) in two homologous contralateral sites of inferior premolars
* Miller Class I or II gingival recession
* Absence of radiographic bone loss
* Vital tooth or with adequate endodontic treatment
* Root surfaces without caries
* Good oral hygiene (plaque index \< 20%)

Exclusion Criteria:

* Allergic to penicillin
* Presenting systemic disease that impede surgical procedure
* Smokers
* Pregnancy
* Intake of calcium channel blockers that cause gingival augmentation

Primary outcomes:
measure: keratinized tissue width
timeFrame: 18 years
Secondary outcomes:
measure: Probing depth
timeFrame: 18 years
measure: Attachment level
timeFrame: 18 years
measure: Recession depth
timeFrame: 18 years
Other outcomes:
Locations:
city: Bauru
country: Brazil
facility: Bauru School of Dentistry
state: Sao Paulo
Study officials:
References:
citation: Cummings LC, Kaldahl WB, Allen EP. Histologic evaluation of autogenous connective tissue and acellular dermal matrix grafts in humans. J Periodontol. 2005 Feb;76(2):178-86. doi: 10.1902/jop.2005.76.2.178.
citation: Agarwal C, Tarun Kumar AB, Mehta DS. Comparative evaluation of free gingival graft and AlloDerm((R)) in enhancing the width of attached gingival: A clinical study. Contemp Clin Dent. 2015 Oct-Dec;6(4):483-8. doi: 10.4103/0976-237X.169838.
Clinical trial NCT01666301: ESAs, Reticulocyte Dynamic and Hemoglobin Variability
Official title: Reticulocyte Dynamic and Related Hemoglobin Variability in Hemodialysis Patients Treated With Darbepoetin Alfa and C.E.R.A.: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erythropoiesis Stimulating Agent Pharmacodynamics
Keywords: Erythropoietin stimulating agents
Hemoglobin
Reticulocytes
Variability
Lead sponsor: Ospedale Regionale di Locarno
Sponsor class: OTHER
First posted: 2012-08-16
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Background: In a simulation based on a pharmacokinetic model we demonstrated that increasing the erythropoiesis stimulating agents (ESAs) half-life or shortening their administration interval decreases hemoglobin variability. The benefit of reducing the administration interval was however lessened by the variability induced by more frequent dosage adjustments. The purpose of this study was to analyze the reticulocyte and hemoglobin kinetics under different ESAs and administration intervals in a collective of chronic hemodialysis patients.

Methods: The study was designed as an open-label, randomized, four-period cross-over investigation, including 30 patients under chronic hemodialysis at the regional hospital of Locarno (Switzerland) in September 2009 and lasting 2 years. Four treatment strategies (C.E.R.A. every 4 weeks Q4W and every 2 weeks Q2W, Darbepoetin alfa Q4W and Q2W) were compared with each other. The mean square successive difference of hemoglobin, reticulocyte count and ESAs dose was used to quantify variability. We distinguished a short- and a long-term variability based respectively on the weekly and monthly successive difference.


Eligibility criteria: Inclusion Criteria:

* chronic patients aged 18 years or older, undergoing dialysis 3 times a week for at least 8 weeks before screening, necessitating continuous subcutaneous treatment with weekly Darbepoetin alfa or Erythropoietin beta to maintain hemoglobin (Hb) targets

Exclusion Criteria:

* pregnancy; not respecting the inclusion criteria

Primary outcomes:
measure: hemoglobin variability
timeFrame: 2 years
Secondary outcomes:
measure: differences in reticulocyte count over time
timeFrame: 2 years
measure: risk of hemoglobin overshooting (HR)
timeFrame: 2 years
measure: superiority of every 2 week administration
timeFrame: 2 years
measure: reticulocyte variability
timeFrame: 2 years
Other outcomes:
Locations:
city: Locarno
country: Switzerland
facility: Ospedale Regionale Locarno
state: Ticino
Study officials:
affiliation: Ospedale Regionale Locarno
name: Luca Gabutti, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forni V, Bianchi G, Ogna A, Salvade I, Vuistiner P, Burnier M, Gabutti L. Reticulocyte dynamic and hemoglobin variability in hemodialysis patients treated with Darbepoetin alfa and C.E.R.A.: a randomized controlled trial. BMC Nephrol. 2013 Jul 22;14:157. doi: 10.1186/1471-2369-14-157.
Clinical trial NCT01954901: Hyperbaric Oxygen for Wagner II Diabetic Lower Extremity Ulcers
Official title: Hyperbaric Oxygen for Wagner II Diabetic Lower Extremity Ulcers: a Double-blind, Randomized,Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Wagner Grade 2 Lower Extremity Ulcers
Lead sponsor: David Grant U.S. Air Force Medical Center
Sponsor class: FED
First posted: 2013-10-07
Enrollment: 2
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: The purpose of this proposed DoD study is to determine if hyperbaric oxygen therapy (HBOT) plus standard wound care is more effective than standard wound care alone in the rate of healing and prevention of major amputation (metatarsal and proximal) in Wagner grade 2 diabetic lower extremity ulcers.


Eligibility criteria: Inclusion Criteria:

1. Age equal to or greater than 18.
2. Type 1 or 2 diabetes mellitus.
3. Wagner Grade 2 wound for at least 4 weeks. A diagnosis of a Wagner Grade 2 wound necessitates a persistent wound of 4 weeks (5).
4. DoD Beneficiary.

Exclusion Criteria:

1. Impending/urgent amputation due to ongoing or exacerbated infection.
2. Severe depression.
3. Claustrophobia.
4. Seizure disorder.
5. Uncontrolled asthma/severe COPD with pCO2 \> 45 mmHg on arterial blood gas.
6. Grade 4 congestive heart failure.
7. Unstable angina.
8. Chronic/acute otitis media/sinusitis.
9. Major tympanic membrane trauma.
10. Prior chemotherapy with Bleomycin and evidence of deterioration in diffusing capacity after a single hyperbaric oxygen exposure.
11. Candidates for vascular surgery/angioplasty/stenting or patients with major large vessel disease. These patients could have peripheral vascular disease of such severity that hyperbaric treatment would not improve their condition.
12. Vascular surgery/angioplasty within the last 3 months. This exclusion controls for improvements to a patients vasculature and perfusion that occur within 1-2 months after vascular surgery/angioplasty. This will ensure that any perfusion changes to the patient's diabetic wound ulcer area recorded during the study are a result of hyperbaric therapy instead of recent vascular procedures.
13. Women who are breast feeding or of childbearing potential.
14. Dementia or mental disability rendering the potential subject incapable of following instructions or consenting to treatment.

Primary outcomes:
measure: Changes in wound size - wounds measured by length, width and depth
timeFrame: 14 months
measure: Number of wounds healed
timeFrame: 14 months
measure: Number of major and minor amputations
timeFrame: Three Years after initiation of study
Secondary outcomes:
measure: Peri-wound TCOM values
timeFrame: 14 months
measure: Recurrence of ulceration
timeFrame: 14 months
Other outcomes:
Locations:
city: Travis Air Force Base
country: United States
facility: David Grant USAF Medical Center
state: California
Study officials:
affiliation: David Grant Medical Center
name: John B Slade, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01720901: Increased Dose of Icotinib in Advanced None Small Cell Lung Cancer Patients After Routine Gefitinib Therapy
Official title: An Open, Single-Center,Single Arm Trial to Evaluate the Efficacy and Safety of Increased Dose of Icotinib in Advanced None Small Cell Lung Cancer Patients After Routine Gefitinib Therapy
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Non-small Cell Lung Cancer
Lead sponsor: Betta Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2012-11-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of increased dose of icotinib in advanced NSCLC patients who progressed after gefitinib therapy.

Detailed description: This single center, single arm open label study is designed to assess the safety and efficacy of using high dose of Icotinib (Conmana) as a way to treat patients with non-small cell lung cancer that progressed after routine gefitinib therapy by progression-free survival, as well as overall survival and disease control rate. The adverse events and adverse reaction are evaluated as well.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed local advanced or metastatic stage IIIB/IV NSCLC.
* Have been treated with gefitinib and achieved completed response, partial remission, or stable disease within 3 months after first dose of gefitinib.
* At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors.
* Signed and dated informed consent before the start of specific protocol procedures.

Exclusion Criteria:

* Allergic to icotinib.
* Gefitinib excepted, experience of Anti-tumor Monoclonal Antibody or small molecular compounds therapy such as erlotinib or Cetuximab.
* Severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases.

Primary outcomes:
measure: Progression-free survival
timeFrame: 4.5 months
Secondary outcomes:
measure: Overall survival
timeFrame: 12 months
measure: Tumor response
timeFrame: 6 weeks
measure: Adverse Events
timeFrame: 18 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hospital, Central-South Univercity
state: Hunan
Study officials:
affiliation: Xiangya Hospital, Central-South Univercity
name: Hu Chengping, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05076201: Process of Regulation in Addictions: Vulnerability Emotional Factors to Craving
Official title: Process of Regulation in Addictions: Vulnerability Emotional Factors to Craving
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Craving
Emotional Dysfunction
Self-Regulation, Emotion
Alexithymia
Cocaine Addict
Keywords: vulnerability
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: Ramsay santé
First posted: 2021-10-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The aim of this study is to have a better understanding of the relationship between self-controle difficulties (and more specifically the inhibition deficit in impulsivity), emotional regulation disorders such as alexithymia and craving.This study will be the first in France to specify the interactions between self-regulkation processes dysfunctions and emotional dysfunctions in craving.

Detailed description: The main objective is to measure the level of cocaine craving, 6 months after the end of their detoxification treatment (outpatient or full hospitalization), in patients with a diagnosis of moderate to severe dependence (DSM 5) to cocaine and co-addiction, or not, to alcohol and / or psychostimulants. To evaluate cocaïne craving,the questionnaire CCQ-Brief will be used.

Eligibility criteria: Inclusion Criteria:

* Patient, men or women between 18 and 60 years-old
* Patient with a diagnosis of moderate to severe dependence (DSM 5) to cocaine with or without co-addictions to alcohol or psychostimulant.
* Patient on day-hospitalisation or full hospitalisation
* Patient affiliated or beneficiary to a social security scheme.
* Patient having signed the free and informed consent.

Exclusion Criteria:

* Patient with psychiatric disorders psychosis type
* Patient with severe chronic somatic disease.
* Patient participating in another clinical study
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
* Pregnant, breastfeeding or parturient woman.
* Patient hospitalized without consent.

Primary outcomes:
measure: Cocaïne craving evaluation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Clinique privée
Study officials:
References:
Clinical trial NCT01866501: Follow-Up Study Validating a Blended Technique
Official title: A Follow-up Study Validating a Blended Technique for Identifying the Proximal Humerus Intraosseous Vascular Access Insertion Site
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraosseous Vascular Access
Keywords: Intraosseous Vascular Access
IO Access
IO Vascular Access
EZ-IO
Lead sponsor: Vidacare Corporation
Sponsor class: INDUSTRY
First posted: 2013-05-31
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: A Follow-up Study Validating a Blended Technique for Identifying the Proximal Humerus Intraosseous Vascular Access Insertion Site

Detailed description: In 2012, the investigators from Vidacare evaluated 4 techniques commonly used to identify the proximal humerus IO insertion site to determine if one technique resulted in more consistent successful placement of the IO needle set with a higher level of confidence among device operators performing the techniques. Results suggest that a combination of the best features of the 4 techniques may lead to optimal IO needle set placement more consistently. This study is needed to validate the "Blended" proximal humerus IO insertion technique to confirm that use of the technique results in proper site identification among device operators and results in increased confidence.To most closely evaluate the Blended proximal humerus insertion technique and how it is received by clinicians who perform these procedures in actual patients, device operators will include licensed/certified clinicians including, emergency medicine technicians/paramedics and nurses.

Eligibility criteria: Inclusion Criteria:

* Currently licensed/certified Emergency Medicine Technicians, paramedic, or nurse Have had no formal training on use of the proximal humerus IO insertion site Demonstrate proper use of the device and technique during training portion and obtain approval from the device trainer to participate

Exclusion Criteria:

* Previous training on establishing proximal humerus intraosseous vascular access

Primary outcomes:
measure: Successful IO insertion
timeFrame: Day 1 after establishing proximal humerus IO vascular access
Secondary outcomes:
measure: Intraosseous Infusion flow rates
timeFrame: Day 1 after establishing IO vascular access
measure: Time in seconds for fluid delivery from the proximal humerus to the heart, using visualization of contrast injection under fluoroscopy.
timeFrame: Day 1 after IO insertion
measure: Relationship between IO and peripheral venous blood
timeFrame: Day 1 after establishing IO vascular access and peripheral venous access
Other outcomes:
Locations:
city: Spring Branch
country: United States
facility: Bulverde-Spring Branch EMS
state: Texas
Study officials:
affiliation: Vidacare Corporation
name: Larry J Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04609501: Delivery During Covid-19 Pandemic: Implications for Obstetrics, Maternal Psychopathology, and Mother-Infant Relationship
Official title: Delivery During Covid-19 Pandemic: Implications for Obstetrics, Maternal Psychopathology, and Mother-Infant Relationship in the Shadow of a Socioeconomic Crisis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Delivery; Trauma
Covid19
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2020-10-30
Enrollment: 440
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women who delivered during the Covid-19 pandemic

Brief summary: The Coronavirus 2019 (COVID-19) pandemic has brought about unprecedented social, economic and mental-health challenges, especially for vulnerable populations such as pregnant and post-partum females. In this study, we aimed to evaluate the relations between the fear of COVID-19 and postnatal depression symptoms.

Detailed description: This is a multicenter prospective cohort study of childbearing women during COVID-19. Participants completed a comprehensive online questionnaire including demographic, socioeconomic, obstetric, and postnatal mental-health questionnaires. Data were verified with each center's perinatal database and information regarding physiological stress during pregnancy/birth was also collected. Fear of COVID-19 was evaluated using the validated Fear of COVID-19 Scale and postnatal depression was evaluated using the EPDS. Pre-existing maternal disability was defined as prior physiological or psychological chronic health condition.

Eligibility criteria: Inclusion Criteria:

* women who delivered during the Covid-19 pandemic at the site, since 01-March-2020

Exclusion Criteria:

* women age 18 and below
* Gestational age under 34 weeks
* Intra Uterine Fetal Demise
* Ante-partum Fetal Demise
* Maternal post partum death

Primary outcomes:
measure: Evaluation of COVID-19 during pregnancy
timeFrame: 1 year after delivery
measure: The relations between fear of COVID-19 and postnatal depression symptoms.
timeFrame: 1 year after delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Rinat Gabbay-Benziv, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01546701: Buprenorphine in Acute Renal Colic Pain Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Pain Management
Renal Colic
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether sublingual Buprenorphine is as effective as Iv Morphine sulfate on pain control of the patients with acute renal colic in the emergency department.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of acute renal colic; positive urinalysis of hematuria; pain score more than 3 in Numerical Rating Score (NRS); patients sign the informed consent to enroll.

Exclusion Criteria:

* previous history of seizures; cardiovascular, hepatic, renal or metabolic diseases;
* febrile patients (T \> 38°C);
* hemodynamically unstable patients ( Systolic Blood Pressure \< 90 mmHg);
* pregnant patients;
* patients with abdominal tenderness as a sign of peritoneal inflammation;
* any clinical suspicion for diseases other than urolithiasis like abdominal aortic aneurysm or dissection;
* patients with a history of drug addiction or known allergy to opioids;
* patients who had used analgesics 6 hours before arriving.

Primary outcomes:
measure: change in pain score
timeFrame: 20 and 40 minutes
Secondary outcomes:
measure: treatment side effects
timeFrame: 40 minutes
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: TUMS
Study officials:
affiliation: TUMS
name: Mohammad Jalili, MD
role: STUDY_DIRECTOR
References: