louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00178542: Change in Thrombin Generation Potential and Thromboelastography During the Menstrual Cycle
Official title: Changes in Thrombin Generation Potential and Thromboelastography During the Menstrual Cycle
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Von Willebrand Disease
Keywords: von Willebrand Disease
Healthy Women and Women with von Willebrand Disease
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: The ZLB Behring Foundation
First posted: 2005-09-15
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Females with a diagnosis of von Willebrand Disease

Brief summary: The primary objective of this study is to describe characteristics and trends for thrombin generation (TG) and thromboelastography (TEG) at 4 time points during the menstrual cycle.

Detailed description: We propose that TG and TEG will be more sensitive than traditional coagulation assays to detect physiologic variation in hemostasis, fibrinolysis, and platelet activation throughout the menstrual cycle. We expect that TG and TEG will better discriminate patients with vWD than traditional coagulation studies during the menstrual cycle. In this study we plan to measure TG and TEG in healthy women and women with von Willebrand's disorder during four phases of the menstrual cycle. We will compare specific measurements of endogenous thrombin generation potential from the TG and fibrinolysis and platelet activation from the TEG with standard measures of coagulation, fibrinolysis, and platelet activation markers during the menstrual cycle.

Eligibility criteria: Inclusion Criteria:

* Females of reproductive age with regular menstrual cycles and a diagnosis of von Willebrand disease according to the International Society of Thrombosis and Hemostasis diagnostic criteria.

Exclusion Criteria:

* Females who are pregnant, or have a history of endocrinopathy or hormone imbalance
* History of hysterectomy or bilateral oophorectomy
* History of ovarian or uterine cancer
* Use of intrauterine device
* Use of antifibrinolytic therapy, hemostatic agents, or anti-platelet agents.

Primary outcomes:
measure: Endogenous Thrombin Potential
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Deborah Brown, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04732442: Changes in Inflammatory Response After Immunonutrition Compared to Standard Nutrition in Colorectal Cancer Tissue
Official title: Changes in Inflammatory Response After Immunonutrition Compared to Standard Nutritional Support in Colorectal Cancer Tissue - Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Nutrition Aspect of Cancer
Keywords: immunonutrition
colon cancer
inflammatory response
perioperative care
randomized controlled trial
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized 2-arm controlled trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is Randomized Controlled Trial, in which investigators will estimate the impact of the use of immunonutrition support compared to standard nutritional support in the preoperative period in patients with colorectal cancer.

Detailed description: The first choice of treatment in colorectal cancer is surgery. Nutritional support in form of oral nutritional supplements (ONS) in the preoperative period is widely accepted in reducing the incidence of perioperative complications and immunonutrition is generally recommended. However, there is little clinical data regarding the impact of such treatment on a tumor biology.

Investigators want to perform Randomized Controlled Trial to explore the impact of the use of immunonutrition in relation to standard nutritional support in the preoperative period on alternating the expression of inflammatory response cytokines expression and leukocytes infiltration in tumor tissue in patients operated for colorectal cancer.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of colon cancer during preoperative colonoscopy confirmed by histopathological examination.

Exclusion Criteria:

* emergency/urgent operation
* active infection
* inflammatory bowel diseases in history
* other systemic immune disorders
* the necessity of preoperative neoadjuvant treatment (radiotherapy or chemotherapy)
* metastatic disease, or local infiltration of cancer which was described as T4 stage in preoperative CT scan
* patients who were not able to intake at least 85% of administrated ONS doses

Primary outcomes:
measure: Change in expression of inflammatory cytokines in tumor tissue samples obtained prior and after intervention.
timeFrame: up to 13 months
Secondary outcomes:
measure: Changes in tissue neutrophil infiltration after preoperative nutritional intervention in tumor tissue samples obtained prior and after intervention.
timeFrame: up to 13 months
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: 2nd Department of General Surgery, Jagiellonian University Medical College
state: Małopolska
Study officials:
affiliation: Jagiellonian University
name: Michał Pędziwiatr, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06722742: Use of Iv Tramadol and Ketamine for Prevention of Post Spinal Anesthesia Shivering
Official title: Frequency of Shivering Among Patient Treaed With IV Tramadol Versus Iv Ketamine in Prevention of Post Spinal Anesthesia Undergoing Cesarean Section: Rendomiced Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Shivering, Spinal Anesthesia
Keywords: shivering
Spinal anesthesia
Ketamine
Tramadol and Metclopromide
Lead sponsor: Liaquat National Hospital & Medical College
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 250
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: \*Ketamine:\* Ketamine is a medication that can help reduce shivering by blocking certain nerve signals in the brain. It's like a "nerve blocker" that helps calm down the body's shivering response.

- \*Tramadol:\* Tramadol is a pain medication that can also help reduce shivering. It works by affecting the brain's temperature regulation centers, which helps to reduce the shivering response.

Detailed description: Post-spinal shivering is when a patient starts shaking or shivering after receiving spinal anesthesia. This can be uncomfortable and even scary for the patient.

Using ketamine and tramadol to reduce post-spinal shivering can have several benefits, including:

* Reduced discomfort and anxiety for the patient
* Improved patient satisfaction
* Reduced need for additional medications or interventions
* Faster recovery times

Eligibility criteria: Inclusion Criteria:

* Pateint for elective cesarean section
* Age 18 to 40 years
* ASA 1 and 2

Exclusion Criteria:

* ASA 2 and 3
* Cesarean section requiring general anesthesia
* Hypersensitivity to Ketamine, Tramadol and Opiods
* History of cardiovascular disease

Primary outcomes:
measure: Shivering
timeFrame: 20 minutes to 12 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Liaquat National Hospital and Medical College
state: Sindh
city: Karachi
country: Pakistan
facility: Liaquat National Hospital and Medical College
state: Sindh
city: Karachi
country: Pakistan
facility: Liaquat National Hospital and Medical College
state: Sindh
Study officials:
affiliation: Liaquat national hospital and medical college
name: Nazish Dr Nazish Kanwal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01569542: Crossed Leg Sign and it's Correlation With Significant Pathology
Official title: Crossed Leg Sign and it's Correlation With Significant Pathology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pathology
Lead sponsor: Uelk, J. Daniel, D.O.
Sponsor class: INDIV
First posted: 2012-04-03
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This study should include all comers. To exclude a patient population would add a selection bias.

Brief summary: By determining the correlation of a Crossed Leg Sign with significant pathology, a clinician would then be able to use this correlation to risk stratify his/her patients for significant pathology.

Detailed description: By determining the correlation of a Crossed Leg Sign with significant pathology, a clinician would then be able to use this correlation to risk stratify his/her patients for significant pathology. Therefore, by determining the sensitivity and specificity of this physical exam finding, the clinician would have a better idea of the patients clinical management, including diagnostic testing and ultimate treatment of the patient. Crossed Leg Sign will be defined in this study as: any patient observed in the Emergency Department with sustained crossed legs. To my knowledge, crossed legs have never been evaluated in regards to it's correlation with significant pathology. This could potentially add another physical exam finding to be used by the clinician.

Eligibility criteria: Inclusion Criteria:

* Any patient observed in the Emergency Department with sustained crossed legs.

Exclusion Criteria:

* Any patient not observed to have sustained crossed legs and is not being used as a control.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Wyandotte
country: United States
facility: Henry Ford Wyandotte Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Health System
name: John D Uelk, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02701842: ImPACT Online Clinical Study
Official title: ImPACT Online Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Concussion
Lead sponsor: ImPACT Applications, Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-08
Enrollment: 400
Sex: ALL
Minimum age (years): 12
Maximum age (years): 59
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The researchers want to find out more about a standalone software application, ImPACT Online and how it relates to other commonly used tests of memory, attention and reaction time. ImPACT Online is a computer-based neurocognitive test for concussion management. The test was designed to help measure the effects of concussion on cognitive processes (for example, memory, attention, brain speed) and visual functioning.


Eligibility criteria: Inclusion Criteria:

* Age: 12-59
* Primary English speaking or fluent in English.
* No known special education diagnosis excluding a 504 designation.
* Currently not suffering from a concussion or being treated for a concussion.
* No known physical or psychological impairment that would affect their ability to perform the test.
* An average or above average score on the RIST (Reynolds Intellectual Screening Test).

Exclusion Criteria:

* Documentation of a known special education diagnosis other than a 504 designation.
* English is not their primary language nor are they proficient in the English language.
* Currently suffering from a concussion or being treated for a concussion.
* A below average score on the RIST.

Primary outcomes:
measure: Validity is established through correlation studies with well-known measures of memory and processing speed.
timeFrame: 12 Months
measure: Reliability will be established through a test/re-test to establish results should be stable over time.
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: ImPACT Applications Inc.
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05339542: Platelet Rich Plasma in Plantar Fasciitis
Official title: Musculoskeletal Ultrasound Changes in the Plantar Fascia After a Single Injection of Platelet Rich Plasma Compared to Steroid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Plantar Fascitis
Keywords: degenerative plantar fasciitis
platelet rich plasma
ultrasound guided injection
heel pain
interventional rheumatology
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the study will include two groups. Group I (study group) will be injected PRP. Group II (control group) will be injected methylprednisolone
Primary purpose: TREATMENT

Brief summary: a number of patient diagnosed as degenerative plantar fasciitis will be collected and divided into two groups, group I will be injected by platelet rich plasma and group II will be injected methylprednisolone

Detailed description: the study will include 100 patients diagnosed as degenerative plantar fasciitis and will be evaluated by musculoskeletal ultrasound by two observes and the will divided randomly into two groups who will be injected under ultrasound imaging by either Platelet rich plasma or methylprednisolone. selection of patient will be randomly and the study will be double blinded.

Eligibility criteria: Inclusion Criteria:

\* Clinical diagnosis of plantar fasciitis

Exclusion Criteria (history or current):

* Rheumatic diseases
* Foot Trauma
* Neurological diseases
* Thyroid disease
* Diabetes mellitus
* Chronic Renal Failure

Primary outcomes:
measure: visual analogue scale
timeFrame: 3 months
measure: Manchester-Oxford Foot Questionnaire
timeFrame: 3 months
Secondary outcomes:
measure: echogenicity in longitudinal scan gray scale ultrasound
timeFrame: 3 months
measure: plantar fascia thickness at the insertion in longitudinal scan of the heel
timeFrame: 3 months
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minya university
Study officials:
References:
Clinical trial NCT03327142: EUS-guided FNA in the Study of the Adrenal Gland
Official title: EUS-guided FNA in the Study of the Adrenal Gland: National Retrospective Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adrenal Gland Disease
Adrenal Tumor
Keywords: Adrenal Gland
Endoscopic Ultrasound Guided FNA
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2017-10-31
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Nationwide. Mailing-invitation to Spanish Society of Digestive Endoscopy (SEED) partners. Participation: 17 Spanish centers.

Brief summary: To analyze the diagnostic performance, safety, impact on clinical management, predictors of malignancy and cyto-pathological correlation of the EUS-FNA with AG. National multicenter retrospective study. Mailing-SEED partners. Participation: 17 Spanish centers. Inclusion period: April / 2003 to April / 2016 Inclusion criteria: All AG (Left / Right) punctured by EUS.

A review of 205 EUS-FNA of AG in 200 patients is included.

Detailed description: INTRODUCTION: The EUS has proven useful in the study and evaluation of the adrenal gland (AG) by endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA), in both the left and right glands.

OBJECTIVE: To analyze the diagnostic performance, safety, impact on clinical management, predictors of malignancy and cyto-pathological correlation of the EUS-FNA with AG.

MATERIALS AND METHODS: National multicenter retrospective study. Mailing-SEED partners. Participation: 17 Spanish centers. Inclusion period: April / 2003 to April / 2016 Inclusion criteria: All AG (Left / Right) punctured by EUS. Variables reviewed: Demographic characteristics, clinical, extension studies, USE and pathological data. Comparison between variables; and estimation of multivariate logistic model for cytology, mortality and therapeutic change.

Eligibility criteria: Inclusion Criteria:

* All adrenal gland (Left / Right) punctured by endoscopic ultrasound

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: retrospective analysis form 2003 to 2016
Secondary outcomes:
measure: number of adverse events related to the procedure
timeFrame: retrospective analysis, last 10 years
measure: Predictors of malignancy
timeFrame: retrospective analysis, last 10 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06110442: Opportunistic Fragility Fracture Risk Estimates From Radiographs
Official title: Opportunistic Fragility Fracture Risk Estimates From Radiographs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoporosis
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2023-10-31
Enrollment: 497
Sex: ALL
Minimum age (years): 20
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Representative population

Brief summary: The proposed study will predict a patients' risk of having osteoporosis by using a combination of the IBEX BH (Bone Health) software outputs and other clinical risk factors such as age, gender, medical history and lifestyle. A comparison will be made between the IBEX BH prediction and the one calculated in current clinical practice using a tool called FRAX (Fracture Risk Assessment Tool) which combines clinical risk factors with results from a Dual Energy X-ray Absorptiometry (DXA) assessment.

The study involves conducting these assessments on several new anatomies including Knee, Ankle and Pelvis, to extend the market reach and clinical utility of IBEX BH. The expected outcome of the study is that the IBEX BH will offer better decision support to clinicians in terms of referral on for a DXA scan or osteoporosis investigations than available today.


Eligibility criteria: For the collection of test data in the study.

Inclusion Criteria:

* Male or female
* 50 years of age or over

Exclusion Criteria:

* Women who are pregnant or are breastfeeding.
* Participants who have sustained fractures in both hips.
* Unwilling or unable to provide informed consent.

For the collection of healthy-normal data in the study.

Inclusion Criteria:

* Male or female
* 20-30 years of age

Exclusion Criteria:

* Women who are pregnant or are breastfeeding.
* Participants who have sustained fractures in both hips.
* Unwilling or unable to provide informed consent.

Primary outcomes:
measure: T-scores as calculated by IbexBH and DXA
timeFrame: 2 hours on 1 visit only
Secondary outcomes:
measure: Estimated 10-year risk of major osteoporotic fracture as outputted by FRAX (with and without DXA aBMD (Areal Bone Mineral Density) and IbexBH)
timeFrame: 2 hours on same visit as above
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter
Study officials:
References:
Clinical trial NCT01162642: Green Tea Anticancer Mechanisms in Smokers
Official title: Green Tea Anticancer Mechanisms in Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Healthy moderately heavy smokers
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2010-07-14
Enrollment: 43
Sex: ALL
Minimum age (years): 23
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether green tea may lower the risk of certain cancers.

Detailed description: Green tea contains phytochemicals, especially flavonoids. Phytochemicals are not absolutely required for normal functions, but may confer health benefits such as antioxidant actions. One can live without phytochemicals, but one may live longer and better with them. The phytochemicals in tea have been proposed to inhibit cancer onset via several different mechanisms. An obvious question is: Can anti-cancer actions of green tea be duplicated by black tea, which in the USA, is consumed more than green tea? The question remains unanswered, and will not be addressed by this project since many questions about green tea have not been answered yet. The contents of both type teas overlap in flavonoids, but green tea has more of the agents thought to be most effective. For example, some of the research cited below uses the flavonoid epigallocatechin gallate. Green tea has 5 times more of this flavonoid than black tea.

This study has two purposes. First, a case will be made that green tea may have several anti-cancer mechanisms, but this contention is not well confirmed by human intervention studies. This case will be made by addressing four questions. Second, justification will be given for the choice of mechanisms to be examined in this project's human intervention.

Eligibility criteria: Inclusion Criteria:

* Healthy 23-40 year old males and non-pregnant females, who are moderately heavy smokers (1-1.75 packs/day, \> 2 years)

Exclusion Criteria:

* Habitual tea intake
* Habitual flavonoid supplementation
* Soy product intake over twice a week (soy is high in flavonoids).
* Pulmonary diseases
* Chronic or acute infection
* Admission of heavy alcohol intake (\> 14 beers or drinks a week)
* Body mass index (BMI) \> 30 (moderately overweight subjects will be taken)
* Abnormal EKG
* History of heart or other major health problems (ie arthritis, diabetes).
* Subjects with slightly high blood pressure will be eligible for the project, but more severe hypertension (\>150/100)

Primary outcomes:
measure: Antioxidant effects of green tea versus placebo consumption.
timeFrame: Measured at post treatment
Secondary outcomes:
measure: Non-antioxidant, cancer-relevant effects of green tea consumption
timeFrame: Measured at pre-treatment and post treatment
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Philip Diaz, M.D.
role: PRINCIPAL_INVESTIGATOR
References: