louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06528886: V-notes Hysterectomy With Regional Anesthesia
Official title: V-notes (Transluminal Endoscopic Surgery Through Natural Orifices) Hysterectomy With Regional Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Regional Anesthesia Morbidity
Lead sponsor: Sanliurfa Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-07-30
Enrollment: 17
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Transluminal endoscopic surgery performed through the natural opening via the vagina is a more comfortable, scarless and less complicated method for patients. This method is similar to laparoscopic surgery and is usually performed under general anesthesia. Regional anesthesia is known to be the most comfortable anesthesia type and has less pain, nausea and vomiting during postoperative recovery. Our aim in this study is to evaluate the results by performing the surgery under regional anesthesia.


Eligibility criteria: Inclusion Criteria: Female patient between the ages of 30-70 Preoperative anesthesia evaluation will be evaluated as ASA 1-2 according to the American Society of Anesthesiologists (ASA) physical status Patients who are given a hysterectomy indication due to uterus, cervix and/or adnexal condition and will undergo V-NOTES will be included in the study.

Exclusion Criteria:

Patients contraindicated for spinal anesthesia or pneumoperitoneum, those with a history of tubo-ovarian abscess, deep endometriosis or suspected pelvic adhesions

Primary outcomes:
measure: pain score
timeFrame: postoperative first 24 hours
measure: complications
timeFrame: postoperative first 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: Sanliurfa Education and Research Hospital
city: Şanlıurfa
country: Turkey
facility: Sanliurfa Education and Research Hospital
Study officials:
affiliation: Sanliurfa Education and Research Hospital
name: alev esercan, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00855686: Memantine Versus Placebo in Parkinson's Disease Dementia or Dementia With Lewy Bodies
Official title: A Randomised, Double-blind, Placebo-controlled, 6-month Study of the Efficacy and Safety of Memantine in Patients With Parkinson's Disease Dementia or Dementia With Lewy Bodies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Parkinson's Disease Dementia
Dementia With Lewy Bodies
Keywords: Memantine
Cognition
Parkinson's Disease Dementia
Dementia With Lewy Bodies
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2009-03-04
Enrollment: 199
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this exploratory study is to determine whether memantine can provide benefits on clinical symptoms in patients with Parkinson's Disease Dementia or Dementia with Lewy Bodies.

Detailed description: The objective of this exploratory study is to assess the benefits of memantine compared to placebo in out-patients with a diagnosis of Parkinson's Disease Dementia or Dementia with Lewy Bodies (mild to moderate severity) over a 6-month period. This is a multinational, randomised, double-blind, parallel-group, placebo-controlled, fixed-dose study with specific cognitive (attention, executive function, visual perception and memory), behavioural, functional and global measures.

Eligibility criteria: Inclusion Criteria:

* The study population will consist of male or female outpatients at least 50 years of age with mild to moderate disease severity (MMSE 12 to 24 inclusive) according to UKPDS and DSM IV TR criteria (for PDD patients) and the third report of the DLB consortium (for DLB patients) and who have a knowledgeable and reliable caregiver to accompany the patient to all clinic visits during the course of the study.

Exclusion Criteria:

* Evidence of clinically significant active disease, evidence of other neurological disorders, and current treatment with AChEIs.

Primary outcomes:
measure: No primary or secondary outcome measures are defined. This study is exploratory (see above under detailed description).
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: DE001
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
citation: Emre M, Tsolaki M, Bonuccelli U, Destee A, Tolosa E, Kutzelnigg A, Ceballos-Baumann A, Zdravkovic S, Bladstrom A, Jones R; 11018 Study Investigators. Memantine for patients with Parkinson's disease dementia or dementia with Lewy bodies: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2010 Oct;9(10):969-77. doi: 10.1016/S1474-4422(10)70194-0. Epub 2010 Aug 20.
Clinical trial NCT04047186: Neoadjuvant Immunotherapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules
Official title: Neoadjuvant Anti-PD-1 Therapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Multiple Pulmonary Nodules
Keywords: immunotherapy
Multiple Pulmonary Nodules
Lung Neoplasms
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Neoadjuvant Immunotherapy in Early Stage Non-small-cell Lung Cancer Presenting as Synchronous Ground-glass Nodules: a pilot study

Detailed description: In many cases, non-small-cell lung cancer(NSCLC) manifested as synchronous ground-glass nodules(GGNs) and makes complete surgical resection impossible. At the same time, there is no good solution for the remaining GGNs after resection of the main lesion. Theoretically, pre-operative anti-PD-1 therapy is optimal for promoting anti-tumor immune response on the basis of maximum tumor mutational burden (TMB). In addition, neoadjuvant immunotherapy should have long-term anti-tumor effect even after surgery, because tumor recurrence may cause memory cells activation and differentiation. This is a pilot study to analysis the pathological remission rate of neoadjuvant immunotherapy and adverse events related to the treatment

Eligibility criteria: Inclusion Criteria:

* not less than two GGNs on chest CT
* at least one lesion is diagnosed as NSCLC from biopsy pathology
* no contraindication for surgery
* ECOG score of 0 or 1
* no detectable evidence of distant metastasis

Exclusion Criteria:

* medical history of malignancy
* pregnant or breeding period
* severe organ failure (heart, liver, kidney, and lung)
* high risk of cerebral-cardiovascular evens
* infection out of control
* received or receiving chemo- and radiotherapy
* history of severe reaction due to allergy or hypersensitivity
* severe mental disorder
* currently been enrolled in other trials
* autoimmune or chronic inflammatory disease

Primary outcomes:
measure: pathological response rate
timeFrame: one month
Secondary outcomes:
measure: treatment-related adverse events
timeFrame: one month
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Huazhong Technology Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT00226486: Examination and Treatment of Elderly After a Fall
Official title: Examination and Treatment of Elderly After a Fall- an Analysis in a Medical Technology Evaluation Perspective
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Falls
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
Collaborators: name: Ministry of the Interior and Health, Denmark
First posted: 2005-09-27
Enrollment: 392
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Falls and injurious falls are common among elderly people. The aim of the study is to test a model of multifactorial fall intervention in a Danish population of elderly sustaining a fall. Focus is on prevention of further falls, patients views on fall prevention and a cost-effectiveness analysis.


Eligibility criteria: Inclusion Criteria:

* 65 years old or older
* Having been treated in emergency department or submitted to hospital after a fall
* Living in the Glostrup area.

Exclusion Criteria:

* Fall due to strong external force, new apoplexia cerebri, epileptic seizure, alcohol intoxication.
* Known cognitive impairment
* Not able to walk prior to fall
* Living in institution
* Planned geriatric intervention.

Primary outcomes:
measure: Number of falls and injurious falls in 12 months
Secondary outcomes:
measure: Health related Quality of Life
measure: Fear of falling
measure: Dependence
measure: Use of hospital, primary care etc.
measure: Mortality
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of Geriatrics, Amtssygehuset i Glostrup
Study officials:
affiliation: Glostrup University Hospital
name: Ane B Vind, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vind AB, Andersen HE, Pedersen KD, Joergensen T, Schwarz P. Effect of a program of multifactorial fall prevention on health-related quality of life, functional ability, fear of falling and psychological well-being. A randomized controlled trial. Aging Clin Exp Res. 2010 Jun;22(3):249-54. doi: 10.1007/BF03324804. Epub 2009 Nov 17.
Clinical trial NCT00218686: A Network Intervention for Prevention of HIV Infection in Chennai, India - 1
Official title: Supplement to the Long-term Impact of a Network Outreach Intervention
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: HIV Infections
Keywords: HIV
injection drug use
social networks
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
First posted: 2005-09-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate a peer-based HIV prevention intervention that targets active injection drug users and their drug and sex partners in Chennai India.

Detailed description: The intervention to be tested in this study draws upon theoretical and empirical evidence suggesting that peer educator programs can have significant effects on the risk-related behaviors of both the educators and the peers whom they educate. Specifically, through group and individual focused sessions, participants learn and practice skills designed to reduce drug and sex related risk behaviors. Furthermore, individuals and their main risk partners attend a training session that focuses on risk reduction within their relationship.

Eligibility criteria: Inclusion Criteria:

* drug users
* network members

Primary outcomes:
measure: needle sharing
timeFrame: 3 month
measure: condom use
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chennai, Tamil Nadu
country: India
facility: YRG Care
Study officials:
affiliation: Johns Hopkins University
name: Carl Latkin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01257386: Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis
Official title: Comparative Efficacy and Safety Study in Patients With Active Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Active Ulcerative Colitis
Lead sponsor: Tillotts Pharma AG
Sponsor class: INDUSTRY
Collaborators: name: Zeria Pharmaceutical
First posted: 2010-12-09
Enrollment: 251
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate that import Mesalazine (Asacol®) is non-inferior to the reference drug, marketed Mesalazine, regarding the primary endpoint (reduction of UC-DAI score)in patients with active ulcerative colitis (UC) treated for 8 weeks.


Eligibility criteria: Inclusion Criteria:

* Patients with Ulcerative Colitis (UC) at active phase who are defined to show Ulcerative Colitis-Disease Activitiy Index (UC-DAI) score of 3 or higher but 8 or less, and bloody stool score of 1 or higher

Exclusion Criteria:

* Patients with serious or higher according to diagnostic critera of seriousness and patients with chronic persistent type and with acute serious type in the classification by clinical course

Primary outcomes:
measure: Reduction degree of UC-DAI
timeFrame: Week 8
Secondary outcomes:
measure: 1) Reduction degree of score of each UC-DAI item 2) Remission rate 3) Effective rate
timeFrame: Week 8
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Hospital
Study officials:
References:
citation: Sun J, Yuan Y. Mesalazine Modified-Release Tablet in the Treatment of Ulcerative Colitis in the Active Phase: A Chinese, Multicenter, Single-Blind, Randomized Controlled Study. Adv Ther. 2016 Mar;33(3):400-9. doi: 10.1007/s12325-016-0303-z. Epub 2016 Feb 22.
Clinical trial NCT03575286: Feasibility Study of an Automated Point-of-Care Urine Diagnostic Device for Pregnancy
Official title: Feasibility Study of an Automated Point-of-Care Urine Diagnostic Device for Pregnancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy Related
Keywords: Pregnancy
Urine Testing
Medical Diagnostics
Lead sponsor: Voyant Diagnostics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Northwestern University
First posted: 2018-07-02
Enrollment: 123
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients of childbearing age

Brief summary: The primary purpose of this observational study is to demonstrate the feasibility of an automated point-of-care urine diagnostic device in determining the pregnancy status of patients through urine samples collected from patients at Northwestern University. Our hypothesis is that this automated point-of-care urine diagnostic device will be able to accurately determine a patient's pregnancy status at least 95% of the time.


Eligibility criteria: Inclusion Criteria:

* Patient age 18 years and older, upper age limit of 45 years
* Female patient
* Patients undergoing any procedures for pregnancy diagnosis and confirmation
* English speaking

The following special population will be included:

* Pregnant women

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, and teenagers)
* Prisoners

Primary outcomes:
measure: Accuracy in determining pregnancy status
timeFrame: Time of collection - 1 month post collection
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University, Department of Obstetrics and Gynecology
name: MaryEllen Pavone, MD, MSCI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02596386: Examination of Potassium Levels in Saliva in ESRD Patients
Official title: Examination of Potassium Levels in Saliva in ESRD Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ESRD
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2015-11-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ESRD patients on Hemodialysis

Brief summary: Dialysis patients typically undergo 3 treatments a week every other day with an almost 3 day gap during the weekend. After this gap and before the first dialysis of the week the serum Potassium level is expected to be maximal.

Participants will be recruited from the dialysis clinic at Hadassah Ein Kerem Hospital. The research team would personally meet the patients who answer inclusion criteria f and ask whether they wish to participate.

Each willing participant will undergo Sialometry and blood will be drawn from the dialysis connections for CBC and Biochemistry to establish a baseline.

The study measurements namely Sialometry and collection of Saliva as well as blood test will be taken before the initiation of the dialysis.

Blood testing will be done via the laboratories of the Hadassah hospital. Saliva analysis will be done in the research lab of Prof. Doron Aframian.


Eligibility criteria: Inclusion Criteria:

* Present a predialysis serum potassium level over 5 mmol/L.

Exclusion Criteria:

* Pregnancy

Patients diagnosed with a pathology of the salivary glands such as Sjogren's syndrome, Sialosis, Sialadenitis.

Patients who have received previous radiation therapy to the head and neck region

Primary outcomes:
measure: potassium level in saliva
timeFrame: 7 days
measure: Standard Biochemistry of blood
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah Medical Organization
name: Doron J Aframian, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seethalakshmi C, Koteeswaran D, Chiranjeevi V. Correlation of Serum and Salivary Biochemical Parameters in end Stage Renal Disease Patients Undergoing Hemodialysis in Pre and Post-Dialysis State. J Clin Diagn Res. 2014 Dec;8(12):CC12-4. doi: 10.7860/JCDR/2014/10404.5306. Epub 2014 Dec 5.
citation: Davidovich E, Davidovits M, Peretz B, Shapira J, Aframian DJ. Elevated salivary potassium in paediatric CKD patients, a novel excretion pathway. Nephrol Dial Transplant. 2011 May;26(5):1541-6. doi: 10.1093/ndt/gfq587. Epub 2010 Oct 4.
Clinical trial NCT00534586: Anesthetics and Auditory, Visceral, and Heat Evoked Potentials
Official title: Influence of Anesthetics on Sedation and Antinociception: an Analysis of Auditory Evoked, Visceral Evoked and Heat Evoked Potentials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Pain
SSEP
CHEPS
Propofol
Sevoflurane
S-Ketamine
Remifentanil
Healthy volunteers
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2007-09-26
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the present study is to investigate and quantify the influence of commonly used anesthetics on auditory and pain evoked potentials.

Detailed description: During surgery patients are exposed to different auditory and sensory stimuli. In this study we investigate the influence of different anesthetics to alertness and nociception. In addition to auditory stimuli (AEP as a measure of sedation), Contact Heat Evoked Potential Stimuli (CHEPS), and esophageal evoked potentials from the lower 1/3 of the esophagus are measured to quantify the effects of anesthetics. 60 Volunteers are enrolled into this study. For each drug, three different levels are measured:

* level 1 no medication
* level 2 low dose of medication
* level 3 light sedation dose (volunteer responds to command)

Four drugs are measured in the study:

propofol, sevoflurane, S-ketamine and remifentanil.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) physical status 1-2

Exclusion Criteria:

* drugs that effect the central nervous system
* neurological or psychiatric diseases
* contraindications against propofol, sevoflurane, S-ketamine or remifentanil
* any damages or loss of hearing
* heartburn or any stomach diseases

Primary outcomes:
measure: influence of different drugs on evoked responses
timeFrame: 2 hours
Secondary outcomes:
measure: discrimination of antinociceptive, visceral-perceptive and sedative effects of anesthetics
timeFrame: 2 hours
measure: quantification of anesthetic components of propofol, sevoflurane, S-ketamine and remifentanil
timeFrame: 2 hours
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Technische Universität München, Klinikum rechts der Isar, Department of Anesthesiology
state: Bavaria
Study officials:
affiliation: Klinikum rechts der Isar der Technischen Universität München
name: Eberhard Kochs, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04370886: Recruit Blood Donors Via SMS During Epidemic of COVID-19
Official title: Recruit Blood Donors Via SMS With Different Contents During Epidemic of COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Donation
Lead sponsor: Guangzhou Blood Center
Sponsor class: OTHER_GOV
First posted: 2020-05-01
Enrollment: 456517
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The fight against the spread of the 2019-nCoV epidemic has achieved some success in China, but the epidemic is far from over. A key factor making the epidemic under control in China is the government's call for social distance, which has led to few people going out for donation. As a result, the number of blood donors on the streets has been continuing to decline. Urgent recruitment of blood donors is therefore planned during the period from 30 April to 10 May via emergency recruitment SMS . This study has been designed to compare which information extraction frameworks would be more sensitive to blood donors in emergency situations.

Detailed description: Researches has showed that that the information extraction and processing in emergency was different from the normal situation. To understand what information the blood donors are more sensitive to in an environment that may pose a potential threat to themselves, this interventional study has been designed. Eligible blood donors in Guangzhou Blood Center has been randomly divided into four groups according to their sociological variables, their interval since last blood donation , their history donation times and the location of their last blood donation. Three groups of donors has been randomly selected as interventional groups, and will receive three kindly of emergency blood donor recruitment SMS respectively. The placebo group donors will only receive a May Day greeting SMS.

One blood donor recruitment SMS will emphasize what blood services will do to ensure the safety of blood donors during their donation in 2019-nCoV epidemic, one will shows information about a loss-based framework, while the third one will show information about a benefit-based framework .

Eligibility criteria: Inclusion Criteria:

* blood donors whose last turning up were between October 31, 2016 to October 31, 2019

Exclusion Criteria:

* Blood donors who were deferral by blood screening result and other situations. Blood donors who have indicated that they would not accept urgent recruitment.

Primary outcomes:
measure: Blood donation rate
timeFrame: 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Blood Center
state: Guangdong
Study officials:
References: