louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03187236: Registry for Chronic Obstructive Pulmonary Disease With Anxiety and Depression in China
Official title: The Early Detection, Clinical Course and Prognosis of Anxiety and Depression in Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Anxiety
Depression
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 1906
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stable COPD patients

Brief summary: Anxiety and depression are common comorbidities of chronic obstructive pulmonary disease (COPD). However, the exact prevalence is not known in China. COPD patients with anxiety and depression tend to have more severe symptoms and worse prognosis, but the related evidences are not strong enough. The study aim to investigate the prevalence and long-term outcome of anxiety and depression in COPD.


Eligibility criteria: Inclusion Criteria:

* Stable chronic obstructive pulmonary disease (COPD) patients

Exclusion Criteria:

* Patients with bronchial asthma or other severe pulmonary diseases or having received pulmonary surgery in 6 months
* Patients with tumor history during past 5 years
* Patients with COPD exacerbations during past 4 weeks
* Participants in clinical trials
* Patients in pregnancy or breastfeeding
* Patients unable to complete questionaire independently
* Patients older than 80 years old
* Patients receiving long-term domiciliary oxygen therapy

Primary outcomes:
measure: moderate and severe COPD exacerbations
timeFrame: 3 years
Secondary outcomes:
measure: All-cause mortality
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT02331836: Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy
Official title: Endocuff-assisted Versus Cap-assisted Versus Standard Colonoscopy for Adenoma Detection: A Randomized Controlled European Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Polyps
Colorectal Adenomas
Keywords: adenoma detection rate
polyp detection rate
withdrawal time
coecal and ileum intubation rate
Lead sponsor: Helios Albert-Schweitzer-Klinik Northeim
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 561
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: DIAGNOSTIC

Brief summary: Comparison of Endocuff-assisted, Cap-assisted and Standard colonoscopy for assessment of the adenoma detection rate (ADR)

Detailed description: The Endocuff is a medical device, approved in 2012 by the American Food and Drug Administration, which was also authorized by the European Agency for the Evaluation of Medicinal Products. The aim of the cuff is to optimize the view of the colonic mucosa. There is also a transparent cap on the market, which is used in colonoscopy for a better evaluation of the mucosa and polyp detection. The goal of this project is to conduct a prospective randomized trial for clarification of the hypotheses, whether the usage of the Endocuff increases the detection rate of adenomas compared to the transparent cap or compared to standard colonoscopy.

Eligibility criteria: Inclusion Criteria:

* Colonoscopy independent from indication
* Age ≥ 18
* Patient is able to provide informed consent for the procedure

Exclusion Criteria:

* Inflammatory Bowel Disease stenosis
* Pregnant of nursing patient
* Acute diverticulitis
* Active Inflammatory Bowel Disease
* Age ≤ 18
* Coagulation disorder (INR\>1.4 , Thrombocytes \< 50000/µl)

Primary outcomes:
measure: Adenoma detection rate
timeFrame: 1 year
measure: Polyp detection rate
timeFrame: 1 year
Secondary outcomes:
measure: Bowel preparation result
timeFrame: one day
measure: Coecum intubation rate
timeFrame: one year
measure: Ileum intubation rate
timeFrame: one year
measure: Coecum intubation time
timeFrame: one day
measure: withdrawal time
timeFrame: one day
measure: mucosal laceration
timeFrame: one day
measure: severe bleeding
timeFrame: one day
measure: perforation
timeFrame: one day
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: University of Muenster
state: North-Rhine Westphalia
city: Göttingen
country: Germany
facility: University Medical Center Göttingen
city: Helmstedt
country: Germany
facility: HELIOS St. Marienberg Klinik Helmstedt
city: Northeim
country: Germany
facility: HELIOS Albert-Schweitzer-Klinik
city: Siegburg
country: Germany
facility: HELIOS Medical Center Siegburg
city: Wroclaw
country: Poland
facility: Wroclaw Medical University
Study officials:
affiliation: Helios Albert-Schweitzer-Hospital
name: Tobias Meister, Prof. Dr.med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03741036: Immediate Implant Placement With Provisionalization Using Different Bone Grafts as a Space Filling Material in the Maxillary Esthetic Zone
Official title: Immediate Implant Placement With Provisionalization Using Autogenous Bone Graft Particulates vs Deproteinized Bovine Bone vs Nano-hydroxyapatite Alloplast as a Space Filling Material in the Maxillary Esthetic Zone
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Implant Failed
Keywords: immidiate
dental implant
immidiate provisionalization
bone graft
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2018-11-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: compare autogenous bone graft, xenograft and nanohydroxyapatite in immediate implant w placement in maxillary esthetic zone with provisionalization

Detailed description: Placement of implants into extraction sockets targets the maintenance of peri implant hard and soft tissue structures and the support of a natural and esthetic contour. The main advantages of immediate implant insertion in comparison with delayed implant placement protocols are as follows: a reduced treatment time, less number of sessions, and, thus, the less invasive procedure. This study examines the clinical performance (survival rate, marginal bone levels and Pink Esthetic Score \[PES\]) of OsseoSpeed™ implants placed into extraction sockets with immediate provisionalization in the anterior maxilla after a follow-up of at least 12 months.

The removal of teeth results inevitably in both horizontal and vertical changes of hard and soft tissue dimensions.

Clinical research has shown that the loss of volume in the extraction sockets is high: the biggest bone volumetric changes take place during the first 12 months from the dental extraction, with a reduction of bone volume of 50%, of which 2/3 (30%) are within the first 3 months.

Nowadays to get success in postextraction implantology means managing the early and irreversible alveolar bone dimensional changes following tooth extraction, in order to minimize the negative effects on the aesthetics final.

Eligibility criteria: Inclusion Criteria:

* Adult patients with badly broken teeth in upper esthetic zone indicated for extraction
* Both sexes.
* No intraoral soft and hard tissue pathology
* No systemic condition that contraindicate implant placemen

Exclusion Criteria:

* Heavy smokers more than 20 cigarettes per day.
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems
* Disorders to implant are related to history of radiation therapy to the head and neck neoplasia

Primary outcomes:
measure: Primary stability (marginal bone loss)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
city: Cairo
country: Egypt
facility: Mohamed tarek
Study officials:
References:
Clinical trial NCT00415636: Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer
Official title: A Phase 1 Dose-Escalation Study to Examine the Safety and Tolerability of IC83/LY2603618 Administered After Pemetrexed 500 mg/m2 Every 21 Days in Patients With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2006-12-25
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of IC83/LY2603618 for the treatment of cancer.


Eligibility criteria: Inclusion Criteria:

* Has at least one lesion that can be evaluated by Response Evaluation Criteria In Solid Tumors (RECIST)
* Has fully recovered from all toxicities due to the following:

  1. Local radiation therapy that ended at least 14 days prior to Cycle 1, Day 1.
  2. Surgery.
* Has a life expectancy of at least 3 months.
* Negative serum pregnancy test.

Exclusion Criteria:

* Is pregnant or breastfeeding.
* Is a woman of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards.
* Is a man of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards.
* Has a history of brain metastases, unless adequately treated and without radiologic evidence of progressive disease for at least 3 months after completion of therapy.
* Has a known active infection.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: baseline up to 24 months
Secondary outcomes:
measure: Pharmacokinetic (PK) Parameter: Maximum Observed Plasma Concentration (Cmax) of IC83/LY2603618
timeFrame: Day 1 and Day 9 of Cycle 1
measure: Pharmacokinetic (PK) Parameter: Area Under the IC83/LY2603618 Plasma Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞])
timeFrame: Day 1 and Day 9 of Cycle 1
measure: Percentage of Participants With Best Overall Response
timeFrame: baseline up to 24 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Arizona
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT-5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT05637736: Effects of an Immersive Virtual Reality Intervention
Official title: Effects of an Immersive Virtual Reality Intervention Combined With Mindfulness-based Therapy on Mental Health in Nurses During the COVID-19 Pandemic: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nurse's Role
COVID-19 Pandemic
Mental Stress
Lead sponsor: Nanjing University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2022-12-05
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Some recent studies demonstrated caregivers may experience negative emotions such as anxiety and sadness, which may also affect normal treatment during the epidemic. As the pandemic continues, mental health support, encouragement , and a sense of purpose are needed to support healthcare workers.


Eligibility criteria: Inclusion Criteria:

* Registered nurses (RN) who work in target departments were included. The target departments mainly included internal medicine, surgical, emergency department, where nurses had direct mutual engagement with patients.

Exclusion Criteria:

* Nurses who have not been involved in the COVID-19 volunteer service.

Primary outcomes:
measure: Depression, anxiety, and stress scale (DASS-21)
timeFrame: up to 8 weeks
measure: The impact of COVID-19
timeFrame: up to 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Wu Ye
state: Jiangsu
Study officials:
References:
Clinical trial NCT03130036: Biodistribution of [11C]Acetoacetate/[18F]Fluorodeoxyglucose in Subjects With Risk Factors for Alzheimer's Disease
Official title: Biodistribution of [11C]Acetoacetate/[18F]Fluorodeoxyglucose in Subjects With Varying Risk Factors for Alzheimer's Disease and Subjects on a Diet Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Memory
Cognitive
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 42
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a single center imaging study that will recruit 60 participants who are enrolled in the Effect of a Ketogenic Diet on Alzheimer's Disease Biomarkers and Symptoms: Brain Energy for Amyloid Transformation in AD (BEAT-AD) Study protocol. This cohort of patients will receive a maximum of 3 \[11C\]Acetoacetate (AcAc)/\[18F\]Fluorodeoxyglucose (FDG) PET scans over 18 weeks as part of this supplemental trial.

Detailed description: The main objective of this study is to examine the brain biodistribution of \[11C\]AcAc/\[18F\]FDG, a proxy for acetoacetate (ketone body)/glucose metabolism in 3 study groups; 1) those without identifiable risk of Alzheimer's disease, 2) asymptomatic individuals with increased risk of Alzheimer's disease (such as pre diabetes),and 3) those with early Alzheimer's disease or MCI. Secondary objectives include determining the association between adipose tissue distribution/function and biomarkers of AD pathology.

Eligibility criteria: Inclusion Criteria:

* Mild cognitive impairment or subjective memory complaints
* Stable medical condition and medications
* Ability to complete baseline assessments

Exclusion Criteria:

* History of a clinically significant stroke
* Sensory impairment (visual, auditory)
* Diabetes requiring medication
* Current use of cholesterol/lipid lowering medications, anticonvulsants, drugs with potential interfering CNS effects (other than cholinesterase inhibitors or memantine), medications with significant anticholinergic activity, anti-parkinsonian medications or regular use of narcotic analgesics
* Untreated hypothyroidism or B12 deficiency

Primary outcomes:
measure: Brain biodistribution of [11C]AcAc
timeFrame: Baseline
measure: Brain biodistribution of [11C]AcAc
timeFrame: Change between baseline and four months
measure: Brain biodistribution of [18F]FDG -
timeFrame: Baseline
measure: Brain biodistribution of [18F]FDG -
timeFrame: Change between baseline and 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Suzanne Craft, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03244436: Emergency Surgery Following Pediatric Catheterization
Official title: Emergency Surgery Following Pediatric Cardiac Catheterization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 190
Sex: ALL
Minimum age (years): 2
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 190 pediatric patients presenting for either diagnostic or interventional cardiac catheterization

Brief summary: We study the outcome and prequesties of emergency surgeries that were necessary following accidents in the pediatric cardiac catheterization lab


Eligibility criteria: Inclusion Criteria:

* patients presenting for diagnostic or therapeutic pediatric cardiac catheterization

Exclusion Criteria:

* none

Primary outcomes:
measure: Discharge from ICU
timeFrame: A 2 years study
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02320136: Recording High Frequency Oscillations in Patients With Tumors and Epilepsy
Official title: Recording High Frequency Oscillations in Patients With Tumors and Epilepsy.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Epilepsy
Tumor
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-12-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1. Patients with epilepsy where a surgical resection is considered.
2. Patients where a tumor will be resected that has caused preoperative seizures.
3. Patients where a tumor will be resected that has not caused preoperative seizures.

Brief summary: The investigators want to characterize high-frequency oscillations (HFOs) in intracranial recordings, which may occur as markers of epileptogenic tissue and also under physiological stimulation.

The investigators want to show that recording of high-frequency oscillations (HFOs) is feasible in our project population both intraoperatively and during presurgical physiological conditions.


Eligibility criteria: Inclusion Criteria:

* Patients intend to be treated at the Klinik für Neurochirurgie
* Patients fall into one of the patient groups: (1) Patients with symptomatic epilepsy with focal and/or secondary generalized seizures resistant to medication where a neurosurgical resection is considered as an intervention of epilepsy surgery. (2)Patients where a tumor is planned to be resected that has caused preoperative seizures. (3) Patients where a tumor is planned to be resected that has not caused preoperative seizures.
* Male and Female subjects 18 years to 99 years of age
* Written informed consent after participants' information

Exclusion Criteria:

* contraindications on ethical grounds
* known or suspected non-compliance, drug or alcohol abuse,
* enrolment into a clinical trial within last 4 weeks

Primary outcomes:
measure: HFO (high-frequency oscillations) occurrence
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universitätsspital Zürich
name: Johannes Sarnthein, Prof Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05297136: Preoperative Endoscopic Pancreatic Stent for Distal Pancreatectomy
Official title: Preoperative Endoscopic Pancreatic Stent to Prevent Pancreatic Fistula After Distal Pancreatectomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreatectomy
Pancreatic Fistula
Keywords: Distal Pancreatectomy
Pancreatic Fistula
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2022-03-28
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Distal pancreatectomy (DP) with or without splenectomy is commonly indicated for pancreatic body or tail lesions. Postoperative pancreatic fistula (POPF) remains the commonest complication after DP. A pre-operatively placed pancreatic stent across papilla can decrease the pressure gradient between pancreatic duct and duodenum. Therefore, the pancreatic juice flow is redirected from the pancreatic transection plane and leakage from pancreatic stump is much reduced. This study aims to evaluate whether pre-operatively placed pancreatic stent can prevent POPF by a randomized controlled trial.

Detailed description: A randomised-controlled trial is performed to evaluate the efficacy of preoperative pancreatic duct stenting in preventing post-operative pancreatic fistula after distal pancreatectomy with or without splenectomy. Patients will be randomised to pre-operative stent group or surgery alone group. Pre-operative pancreatic duct stenting will be performed 1-2 weeks before surgery. The stent will be removed 4 weeks after operation. The post-operative pancreatic fistula rate, morbidity, mortality and total length of stay were compared between the 2 groups.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Elective distal pancreatectomy for primary pancreatic pathology

Exclusion Criteria:

* Informed consent not available
* Emergency distal pancreatectomy
* Presence of pancreatic duct stricture
* Presence of altered anatomy that precludes safe Endoscopic Retrograde Cholangiography (e.g. previous Billroth II gastrectomy)
* History of severe pancreatitis

Primary outcomes:
measure: Number of participants with postoperative pancreatic fistula
timeFrame: Day 3 after operation
Secondary outcomes:
measure: Number of participants developing post-operative morbidity
timeFrame: 90 days
measure: Number of participants developing post-operative mortality
timeFrame: 90 days
measure: Total length of hospital stay of participants
timeFrame: 90 days after endoscopy and operation
measure: Number of participants developing complications related to Endoscopic Retrograde Cholangiography
timeFrame: 14 days after endoscopy
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
affiliation: Clinical Associate Professor (honorary)
name: Kit Fai Lee, MBBS
role: PRINCIPAL_INVESTIGATOR
References: