louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03350009: Markers in Follicular Fluid and in Embryo Culture Medium as a Marker of Oocyte and Embryo Quality
Official title: Markers in Follicular Fluid and in Embryo Culture Medium as a Marker of Oocyte and Embryo Quality
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility/Sterility
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 220
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing IVF procedures at Carmel Medical Center

Brief summary: Assessment of the quality of follicular fluid and early embryo via chemical markers.

Detailed description: The selectin of an embryo for transfer is currently based on detailed morphological assessment and scoring system. morhpokinetics introduced recently to IVF laboratories can define annotations and provide an algorithm for optimal cleavage rates and embryonic development. however more data and validations are requested when it comes to choosing the best single embryo from a cohort of available similarly graded embryos. Consequently, non-invasive quantitative methods for embryo selection prior to transfer have been sought. In the current study metabolic profile of follicular fluid and the embryos produced in IVF procedure will be assessed

Eligibility criteria: Inclusion Criteria:

* Patients undergoing IVF procedures at Carmel Medical Center and are able to sign an informed consent form.
* Female patients age 18-45

Exclusion Criteria:

* Women with any malignancy
* Patient's request to be withdrawn from the study.

Primary outcomes:
measure: Different markers discriminating the studied groups.
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
affiliation: Carmel Medical Center
name: Martha Direnfeld, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01653509: An Exploratory Study to Investigate the Inflammatory Response During a Cold Sore Episode
Official title: An Exploratory Study to Investigate the Inflammatory Response During a Cold Sore Episode
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Herpes Labialis
Keywords: cold sore
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: Labtec GmbH
First posted: 2012-07-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will treat approximately 24 participants who experience cold sores. Patches will be applied to the cold sore for up to ten days, and the symptoms will be measured during daily clinic visits using non-invasive measurement techniques.


Eligibility criteria: Participants who are susceptible to cold sores that reactivate when exposed to ultraviolet (UV) light

Primary outcomes:
measure: Mean Change From Baseline in Blood Flow
timeFrame: Baseline to Day 10
measure: Mean Change From Baseline in Temperature
timeFrame: Baseline to Day 10
measure: Mean Change From Baseline in Color Intensity of Lesions
timeFrame: Baseline to Day 10
Secondary outcomes:
measure: Participant Assessment of Patch Comfort and Noticeability at Day 5
timeFrame: Day 5
measure: Participant Assessment of Patch Comfort and Noticeability at Day 10
timeFrame: Day 10
measure: Participant Assessment of Symptom Intensity at Day 5
timeFrame: Day 5
measure: Participant Assessment of Symptom Intensity at Day 10
timeFrame: Day 10
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: proDERM Institute for Applied Dermatological Research GmbH
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Veltri J, Boon R, Bohling A, Wilhelm KP, Bielfeldt S. A Randomized Exploratory Study to Investigate the Inflammatory Response During an Ultraviolet-Radiation-Induced Cold Sore Episode. Dermatol Ther (Heidelb). 2021 Jun;11(3):983-994. doi: 10.1007/s13555-021-00531-x. Epub 2021 Apr 28.
Clinical trial NCT01384409: A Phase 3 Clinical Study of KW-3357 in Patients With DIC
Official title: A Clinical Study of KW-3357 in Patients Diagnosed as Disseminated Intravascular Coagulation (DIC) by Japanese Association for Acute Medicine-defined DIC Criteria
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Disseminated Intravascular Coagulation (DIC)
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-06-29
Enrollment: 5
Sex: ALL
Minimum age (years): 20
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 KW-3357 with concomitant use of heparin using multi-center, non-comparative, open-label method in patients diagnosed as disseminated intravascular coagulation (DIC) by Japanese Association for Acute Medicine-defined DIC criteria.


Eligibility criteria: Inclusion Criteria:

* Japanese Association for Acute Medicine-defined DIC criteria score \>= 4
* Antithrombin activity \<= 70%
* Written informed consent from patient or guardian

Exclusion Criteria:

* Anamnesis or complication of serious drug allergy
* Serious liver disorder, such as fulminant hepatitis and decompensated cirrhosis
* Pregnant, nursing, or possibly pregnant woman
* Possibility for the promotion of bleeding by concomitant use of heparin

Primary outcomes:
measure: Safety
timeFrame: up to 6 days (or discontinuation)
measure: DIC resolution
timeFrame: 6 days (or discontinuation)
measure: DIC score
timeFrame: Screening, 2, 3, 4, 5, 6 days (or discontinuation)
measure: Mortality
timeFrame: 28 days
measure: Organ symptoms
timeFrame: Screening, 4, 6 days (or discontinuation)
measure: Severity
timeFrame: Screening, 4, 6 days (or discontinuation)
measure: Plasma antithrombin activity
timeFrame: Screening, 2, 3, 4, 5, 6 days (or discontinuation)
Secondary outcomes:
Other outcomes:
Locations:
city: Saga
country: Japan
Study officials:
References:
Clinical trial NCT05816109: The Effect of Superficial Cervical Plexus Block on Postoperative Recovery Quality and Pain in Anterior Cervical Spinal Surgery
Official title: The Effect of Superficial Cervical Plexus Block on Postoperative Recovery Quality and Pain in Anterior Cervical Spinal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Pain
Keywords: Recovery Quality
Postoperative Pain
Superficial cervical block
Cervical block
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Assignment
Primary purpose: TREATMENT

Brief summary: The Effect of Superficial Cervical Plexus Block on Postoperative Recovery Quality and Pain in Anterior Cervical Spinal Surgery

Detailed description: The study was designed as a double-blind, prospective randomized controlled trial.

Blindness; The healthcare professionals who will monitor the patient's pain in the post-operative period will not know whether the superficial cervical plexus block is applied to the patients. Randomization of the patients was planned using computer aided. It is envisaged that 20 participants will be included in the patient group that will have a superficial cervical plexus block and will not have a superficial cervical plexus block. The current pain status in the postoperative period in the patient groups that will or will not have a superficial cervical plexus block is determined by NRS (Numerical rating scale) at rest and in motion at certain hour intervals ( 30.min,1.,6.,12.,24. hours) will be done, when the patients' NRS scores are 4 and above, an additional intravenous analgesic will be administered, and the number of bolus doses with PCA in the first 24 hours will be recorded. The quality of recovery (QoR-40) scoring system will be evaluated at the postoperative 24th hour of both patients with and without superficial cervical plexus block. In addition, the hemodynamic values of the patients will be recorded in these intervals.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing lumbar spinal surgery under elective conditions
* ASA I-III
* Between 18-75 ages

Exclusion Criteria:

refuse during registration

* request to be dismissed from study
* failure to give informed consent
* emergency surgery
* bleeding diathesis
* Presence of contraindications to the LA agents used in this study chronic use of opioids psychiatric disorders the presence of infection at the injection site

Primary outcomes:
measure: Qor-40 test (The recovery quality test)
timeFrame: 24 th hour
Secondary outcomes:
measure: NRS (Numerical rating scale)
timeFrame: 30 minutes,1st hour,6th hour,12th hour and 24th hour]
measure: Postoperative pain
timeFrame: 30 minutes, 1st hour, 6th hour, 12th hourand 24th hour
Other outcomes:
Locations:
city: Aydin
country: Turkey
facility: Adnan Menderes University Faculty of Medicine
Study officials:
References:
Clinical trial NCT02718209: The Development of an In-vitro System to Identify Gynecologic Cancer Cells During Surgical Procedures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecological Malignancies
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2016-03-24
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to examine the efficacy of mid-infrared spectroscopy together with Attenuated Total Reflection (ATR), for the detection of gynecological malignancies in real time during surgery.


Eligibility criteria: Inclusion Criteria:

* Women with one or more tumors in reproductive system

Exclusion Criteria:

* Pregnant women
* Unable to give consent

Primary outcomes:
measure: Gynecological Malignancies Identified in Real Time
timeFrame: One hour
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Ilan Bruchim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03411109: Outcomes of Intrathecal Analgesia in Colorectal Surgery
Official title: Efficacy and Outcomes of Intrathecal Analgesia As Part of an Enhanced Recovery Pathway in Colon and Rectal Surgical Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Keywords: intrathecal analgesia
colorectal
enhanced recovery
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2018-01-25
Enrollment: 601
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients receiving colorectal surgical care at a tertiary care, academic institution.

Brief summary: Multimodal analgesia, sometimes including intrathecal analgesia (IA), is essential in any enhanced recovery pathway (ERP). This study aimed to evaluate the safety, feasibility, and optimal IA regimen in colorectal surgical patients.


Eligibility criteria: Inclusion Criteria:

* All adult colorectal patients from October 2012 through December 2013 in which patients received single-injection IA as part of a multimodal analgesic strategy for ERP.
* Undergoing an elective colorectal operation (minimally invasive or open)

Exclusion Criteria:

* Patients aged \< 18 years
* American Society of Anesthesiologists (ASA) 5 and 6 classification
* pregnancy
* failure to provide research authorization.
* emergent operations

Primary outcomes:
measure: Time to return of bowel function
timeFrame: post resection, approximately up to 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Adam Jacob, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Merchea A, Lovely JK, Jacob AK, Colibaseanu DT, Kelley SR, Mathis KL, Spears GM, Huebner M, Larson DW. Efficacy and Outcomes of Intrathecal Analgesia as Part of an Enhanced Recovery Pathway in Colon and Rectal Surgical Patients. Surg Res Pract. 2018 Mar 1;2018:8174579. doi: 10.1155/2018/8174579. eCollection 2018.
Clinical trial NCT02885909: Inpatient Blood Glucose Control in Taichung Veterans General Hospital
Official title: The Effects of Glucose Control and Monitor on Inflammation in the Hospitalized Patients With Hyperglycemia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: HYPERGLYCEMIA
Keywords: type 2 diabetes
inpatient
glucose control
continue glucose monitor
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2016-09-01
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will be conducted in the ward of Taichung Veterans General Hospital. The patient with hyperglycemia in hospitalization will be enrolled by glucose management team.

Detailed description: This study will be conducted in the ward of Taichung Veterans General Hospital. The type 2 diabetic patient with hyperglycemia in hospitalization are candidates. The glucose will be controlled using the insulin protocal based on the glucose monitor systems. We will assess the effects of insulin protocal and glucose monitor system on the inpatient with hyperglycemia.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetic inpatient
* Fasting glucose \>140 mg/dl or random glucose \>180 mg/dl

Exclusion Criteria:

* incooperative for glucose monitor
* refusal of insulin
* pregnancy

Primary outcomes:
measure: Glucose target
timeFrame: 6 days
Secondary outcomes:
measure: Fasting glucose target
timeFrame: 6 days
measure: Hypoglycemia
timeFrame: times
measure: Vascular Cell Adhesion Molecule 1 (VCAM-1)
timeFrame: 6 days
measure: Brain-Derived Neurotrophic Factor (BDNF)
timeFrame: 6 days
measure: Orexin-A
timeFrame: 6 days
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: I-Te Lee, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03097809: SEEG Investigation of Mood Dysregulation in Epilepsy
Official title: SEEG Investigation of Mood Dysregulation in People With Epilepsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects from the Epilepsy Center at the Cleveland Clinic for surgical treatment of medically refractory epilepsy who would have already had SEEG electrodes placed in cortical and limbic areas for clinical diagnostic purposes

Brief summary: Using the novel analysis of stereo-electroencephalography (SEEG) recordings, this proposal will investigate the activity and connectivity of mood regulation circuits in subjects with suspected epileptic focus who have undergone SEEG electrode implantation for monitoring of seizure activity.

Detailed description: It is well known that epilepsy is associated with mood dysregulation including symptoms of labile mood, impulse control problems, anxiety, depression and increase in incidence of suicide. However, until present the neurobiological basis of mood dysregulation in epilepsy has not been clear and has been mostly attributed to a psychological reaction to the illness. This has severely limited our understanding of the impairments in mood regulation that people with epilepsy often experience and has also limited the development of effective treatment for ameliorating psychosocial dysfunction in people with epilepsy. The identification of these circuits will not only increase our understanding of mood-regulation in epilepsy but also possibly provide biomarkers with which the effectiveness of new treatments can be investigated. Developing better diagnostic measures and treatments for mood dysregulation will be highly beneficial to the quality of life of subjects suffering from epilepsy.

Eligibility criteria: Inclusion Criteria:

* Subjects will be a part of the epilepsy-monitoring unit for long-term SEEG recordings and analysis

Exclusion Criteria:

* Subjects that experience surgical complications during the implant procedure will be excluded from the study

Primary outcomes:
measure: Emotional Face Task and Emotional Go-No Go Task
timeFrame: 2 years
measure: Maintaining and suppressing emotions
timeFrame: 2 years
measure: Resting state cortico-limbic brain connectivity
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation Center for Behavioral Health
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Amit Anand, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02783209: Effect on the Vitreous of the Not Complicated Surgery of the Cataract to the Emmetropic Patient
Official title: Effect on the Vitreous of the Not Complicated Surgery of the Cataract to the Emmetropic Patient
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cataract
Vitreous Detachment
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-05-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study evaluates the association between surgery of the cataract and posterior vitreous detachment, in the emmetropic patient, by comparing eyes operated with eyes not operated in the same group of patients


Eligibility criteria: Inclusion Criteria:

* Adult emmetropic patient
* Without complete posterior vitreus detachment in both eyes before having surgery.

Exclusion Criteria:

* Diabetic retinopathy
* Ophthalmological treatment in progress
* History of ophthalmological surgery

Primary outcomes:
measure: Occurence of vitreous detachment in the operated eye
timeFrame: 3 months after the cataract surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: URC Fondation Ophtalmologique A de Rothschild
Study officials:
References:
Clinical trial NCT02047409: Prognostic Value of Sympathetic Modulation in Patients With Heart Failure
Official title: Prognostic Value of Oscillatory Pattern of Sympathetic Nerve Activity Muscle in Patients With Heart Failure
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: InCor Heart Institute
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2014-01-28
Enrollment: 160
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The sample consisted of patients with heart failure in clinical follow up at the Heart Institute (InCor), University of São Paulo, School of Medicine.

Brief summary: The purpose of this study is to determine whether oscillatory pattern of sympathetic nerve activity muscle is an efficient index for the prognosis of patients with heart failure.


Eligibility criteria: Inclusion Criteria:

* Patients with systolic heart failure and New York Heart Association (NYHA)
* Ischemic, hypertensive, or idiopathic etiology
* Left ventricular ejection fraction less than 40%

Exclusion Criteria:

* Neuromuscular, Orthopedic, Neurologic and Pulmonary Diseases
* Renal failure
* Diabetes mellitus type II

Primary outcomes:
measure: Peripheral autonomic control
timeFrame: 12 months
Secondary outcomes:
measure: Arterial baroreflex control
timeFrame: 12 months
measure: Blood inflammatory markers
timeFrame: 12 months
measure: Cardiac and peripheral autonomic control
timeFrame: 12 months
measure: Functional Capacity
timeFrame: 12 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Heart Institute (InCor), University of Sao Paulo, School of Medicine.
Study officials:
References:
Clinical trial NCT05888909: Multidimensional Accurate Diagnosis and Treatment Technology and Clinical Transformation of Type 2 Diabetes Nephropathy
Official title: Multidimensional Accurate Diagnosis and Treatment Technology and Clinical Transformation of Type 2 Diabetes Nephropathy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetic Nephropathy Type 2
Diabetic Kidney Disease
Type 2 Diabetes
Keywords: Diabetic Nephropathy Type 2
Diabetic Kidney Disease
Type 2 Diabetes
Diagnosis
Treatment
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Science & Technology Commission
name: China-Japan Friendship Hospital
name: Beijing Friendship Hospital
name: Beijing Tongren Hospital
name: Beijing Hospital
name: Dongzhimen Hospital, Beijing
name: Xuanwu Hospital, Beijing
First posted: 2023-06-05
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Type 2 diabetes and type 2 diabetes patients with CKD

Brief summary: Diabetes nephropathy (DN) is one of the most serious microvascular complications of diabetes, and also an important cause of death and disability of diabetes patients. There is no specific clinical staging of type 2 diabetes nephropathy at home and abroad, and there is no comprehensive study to comprehensively describe the occurrence and development of type 2 diabetes nephropathy through sensitive biomarkers, microvascular disease imaging and functional detection, digital markers and other multi-dimensional diagnosis and evaluation methods. Therefore, our research aims to establish a long-term follow-up queue for the whole cycle of diabetes nephropathy, develop multi-dimensional diagnostic and progress digital markers for diabetes nephropathy, develop a multimodal non-invasive diagnostic model and a new clinical staging/typing, and create a multi-dimensional accurate diagnosis and treatment system for type 2 diabetes nephropathy combining traditional Chinese and western medicine.


Eligibility criteria: Inclusion Criteria:

Age ≥ 18 years old, regardless of gender; Type 2 diabetes; Having a complete medical history and clinical data; If the patients with type 2 diabetes combined with CKD underwent renal biopsy, the pathological diagnosis should be clear; Patients voluntarily signs an informed consent form.

Exclusion criteria:

Incomplete medical history or clinical data; Patients with hereditary kidney disease; Combined urinary tract infection; Merge autoimmune system diseases; Patients with malignant tumor were expected to survive less than 6 months; Pregnancy and lactation.

Primary outcomes:
measure: change in estimated glomerular filtration rate (eGFR) from baseline
timeFrame: 24months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
References: