louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04954300: Investigation on the Dynamic Changes in Air Microbiome in Intensive Care Unit
Official title: Investigation on the Dynamic Changes in Air Microbiome in Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hospital Acquired Infection
Keywords: Microbial Colonization
Environmental Exposure
Microbiome
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: No patients were enrolled in this study.

Brief summary: The microbiome of ICU, especially the air microbiome of ICU is not clear. The relationship between the microbiome of ICU and the hospital- acquired infection needs to be clarified. In this study, we try to outline the dynamic changes of microbiome in ICU and give some advice on the prevention of HAI.


Eligibility criteria: Inclusion criteria: no patients were enrolled in this study. Exclusion criteria: no patients were enrolled in this study.

Primary outcomes:
measure: Community of microbiome in ICU
timeFrame: 1 year and a half
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Yuxin Leng, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03855800: Molecular Detection of Advanced Neoplasia in Pancreatic Cysts
Official title: Molecular Detection of Advanced Neoplasia in Pancreatic Cysts (IN-CYST)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pancreas Cyst
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-02-27
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Researchers are trying to find out whether new tests ("biomarkers") of blood, stool, pancreas cyst fluid, or pancreas juice can be used to diagnose malignant or pre-malignant changes in pancreas cysts.

Detailed description: Subjects with Fukuoka Worrisome (FW) or Fukuoka High Risk (FHR) pancreatic cysts will be enrolled and assigned to Immediate Surgery or Clinical Follow-up groups based on clinical management as determined by the treating physicians. Blood, stool, pancreas cyst fluid, and pancreas juice specimens will be collected from participants.

Eligibility criteria: Inclusion Criteria:

* Patients with pancreatic cystic lesions meeting Fukuoka worrisome or Fukuoka high-risk criteris
* Patients with suspected cystic neoplasm of the pancreas
* Able to provide written informed consent

Exclusion Criteria:

* Pregnant and/or nursing
* Incarceration
* Imaging showing possible pancreatic cancer
* Prior history of pancreatic cancer or pancreatic surgery
* History of receiving systemic chemotherapy or abdominal radiation within the last 5 years
* Previous therapy for a pancreatic cystic lesion
* History of pancreatic necrosis
* Diagnosis of cancer (other than non-melanoma skin cancer) within the last 5 years

Primary outcomes:
measure: Biospecimen Acquisition
timeFrame: 5 years
measure: High grade dysplasia (HGD) or cancer diagnosis in Immediate Surgery group
timeFrame: 5 years
Secondary outcomes:
measure: High grade dysplasia (HGD) or cancer diagnosis in clinical follow up group
timeFrame: 5 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Shounak Majumder, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00068900: FFA Metabolism in Different Types of Human Obesity
Official title: FFA Metabolism in Different Types of Human Obesity
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Obesity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2003-09-12
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE

Brief summary: We will give intravenous fat molecules to help us understand how the fat that is released from peoples fat cells is used. This will be done when people are eating, not eating and walking.


Eligibility criteria: Inclusion Criteria: BMI 28-36 -upper body obesity and lower body obesity non-obese BMI 19-24. Females premenopausal. Must be a non-smoker.

Exclusion Criteria: BP\> 160/95 on HTN meds, known systemic illness. Medications that affect fat metabolism. We do no cover travel expenses. Known heart and vascular disease.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
Clinical trial NCT02685800: Recurrent Failures in assIsted Reproductive Techniques (The FIRST Registry)
Official title: A Registry on Outcomes in Women Undergoing Assisted Reproductive Techniques After Recurrent Failures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infertility
Lead sponsor: Casa Sollievo della Sofferenza IRCCS
Sponsor class: OTHER
First posted: 2016-02-19
Enrollment: 624
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive women undergoing ART after recurrent failures.

Brief summary: Assisted Reproductive Technologies (ARTs) are widely used in couples with fertility problems. However, despite ART treatment options have evolved over time, the implantation rate remains rather low.

A possible role for inherited and acquired thrombophilias has been invoked, especially in women with previous implantation failures. However, several factors could play a role in these conditions.

A potential benefit of low-molecular-weight heparin (LMWH) in improving ART outcomes, independently of the presence of thrombophilia, has been recently suggested.

This register is designed in order to better define all possible variables influencing ART outcome and improve clinical management of women with previous implantation failures. During this study the investigators will collect and evaluate clinical data regarding the first cycle in women with previous ART failures.


Eligibility criteria: Inclusion Criteria:

* 2 or more implantation failures/losses of clinical pregnancies after ART
* ART cycle at enrolment
* Informed consent

Exclusion Criteria:

* Ovarian hypofunction
* Uterine pathology
* Hydrosalpinges
* Previous inclusion in the study

Primary outcomes:
measure: Number of live births
timeFrame: 10 months
Secondary outcomes:
measure: Number of clinical pregnancies after ART
timeFrame: 10 months
Other outcomes:
Locations:
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Casa Sollievo della Sofferenza
state: Foggia
Study officials:
affiliation: IRCCS Casa Sollievo della Sofferenza - San Giovanni Rotondo, Foggia, Italy
name: Elvira Grandone
role: PRINCIPAL_INVESTIGATOR
References:
citation: Villani M, Baldini D, Totaro P, Larciprete G, Kovac M, Carone D, Passamonti SM, Permunian ET, Bartolotti T, Lojacono A, Cacciola R, Pinto GL, Bucherini E, De Stefano V, Lodigiani C, Lavopa C, Cho YS, Pizzicaroli C, Colaizzo D, Grandone E. Rationale and design of two prospective, multicenter, observational studies on reproductive outcome in women with recurrent failures after spontaneous or assisted conception: OTTILIA and FIRST registries. BMC Pregnancy Childbirth. 2019 Aug 13;19(1):292. doi: 10.1186/s12884-019-2444-y.
Clinical trial NCT01366300: Effect of Intravenous Lidocaine on BIS-guided Propofol Requirements During General Anesthesia
Official title: Estimation of the Effect of Intravenous Lidocaine on BIS-guided Propofol Requirements During General Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intravenous Anesthetic Interaction "Unrecognized Condition"
Lead sponsor: Pontificia Universidad Catolica de Chile
Sponsor class: OTHER
First posted: 2011-06-06
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this randomized clinical trial is to evaluate the interaction of lidocaine infusion initiated and maintained during surgery, on propofol requirements during general anesthesia.

Detailed description: Use of intravenous lidocaine as a coadjuvant agent during general anesthesia has increased. Lidocaine infusion during and after abdominal surgery decreases postoperative pain and reduces ileus duration, reducing patient´s hospital stay and opioid consumption. Intravenous lidocaine´s effect on other intravenous anesthetics is unclear, and there are no present studies evaluating its interaction on hypnotic anesthetic requirements when using a BIS (Bispectral Index) monitor to maintain an adequate depth of anesthesia. We therefore decided to conduct a randomized controlled trial to evaluate the interaction of systemic lidocaine infusion, initiated and maintained during surgery, on propofol requirements and anesthetic depth as measured by BIS.

Eligibility criteria: Inclusion Criteria:

* ASA I-II patients,
* Between 20 and 65 years of age
* Programed for elective laparoscopic cholecystectomy
* Eligible for total intravenous anesthesia with propofol

Exclusion Criteria:

* Unwillingness to participate in the study
* Adverse reactions to the drugs used in the study
* Use of medications that interfere in local anesthetic metabolism
* History of liver disease, kidney failure, hypoalbuminemia, hypocalcemia or hypophosphatemia
* History of drug or alcohol abuse
* Chronic use of benzodiazepines

Primary outcomes:
measure: Total propofol requirements during bispectral index guided general anesthesia
timeFrame: DAY 1.
Secondary outcomes:
measure: Evaluate effect of intravenous lidocaine infusion on waking time after general anesthesia
timeFrame: DAY 1.
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital Clínico Pontificia Universidad Católica de Chile
state: RM
Study officials:
affiliation: Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile
name: Fernando R Altermatt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06565000: IMPACT of an Instrumented Measurement on a Performance Assessment in Cerebral Palsy Treatment
Official title: IMPACT of an Instrumented Measurement on a Performance Assessment in Cerebral Palsy Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Quantified Motion Analysis
Performance Assessment
Bimanual Performance
Unilateral Cerebral Palsy
Lead sponsor: Centre Médico-Chirurgical de Réadaptation des Massues Croix Rouge Française
Sponsor class: OTHER
First posted: 2024-08-21
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The goal of this study is to assess the impact of passive reflective markers on bimanual performance assessment scores in children with unilateral cerebral palsy.

The main questions it aims to answer are:

* Is it possible to instrument performance assessment without changing the functionnal behaviour of the patient ?
* How is this behavious modified ?

During their usual occupational therpy assessment at the CMCR Massues, participants will do a second bimanual performance assessment with passive reflection markers taped on their trunk, humerus and forearm.

The glocal scores and sub items scors of both instrumented and non instrumented assessment will be compared.


Eligibility criteria: Inclusion Criteria:

* Unilateral cerebral palsy
* With an Occupational therapy assessment planed with the duration of the study

Exclusion Criteria:

* Severe cognitive impairment

Primary outcomes:
measure: Bimanual Performance Score
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: CMCR des Massues
Study officials:
References:
Clinical trial NCT04251000: Infrared Photomodulation Therapy for Seasonal Affective Disorder
Official title: Joovv for Seasonal Affective Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Seasonal Affective Disorder
Lead sponsor: ProofPilot
Sponsor class: INDUSTRY
Collaborators: name: Joovv
First posted: 2020-01-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm pilot study
Primary purpose: PREVENTION

Brief summary: During winter months in northern latitudes use of Joovv device on self-reported non-clinical mental health (aka mood), sleep and energy levels. Participants will also submit Withings and Oura activity and sleep data.


Eligibility criteria: Inclusion Criteria:

* history of mental health issues including clinical depression
* US based
* reasonably active individuals (self report run/gym 3x per week or more)

Exclusion Criteria:

* average daily high temperature in zipcode above 60 degrees through end of March

Primary outcomes:
measure: change self report mood as assessed by Warwick Edinburgh sleep scale
timeFrame: Baseline to 90 day
measure: Change in Sleep Duration and Sleep Quality as measured by consumer connected health device
timeFrame: Baseline to 90 day
measure: Change in activity levels as measured by consumer connected health devices
timeFrame: Baseline to 90 day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: ProofPilot (Virtual Study: https://proofpilot.com)
state: New York
Study officials:
References:
Clinical trial NCT06771700: Intra-operative Assessment of the PRAETORIAN Score During S-ICD Implantation
Official title: Feasibility of an Intra-operative and Non-fluoroscopic Assessment of the PRAETORIAN Score During Subcutaneous ICD Implantation: a Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sudden Cardiac Death
Keywords: S-ICD
Defibrillator
Lead sponsor: Universitätsklinikum Köln
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a pilot study. Patients are treated according to clinical standard. There are additional measurements made in the process but the study protocol does NOT include any deviation from the clinical standard practice.
Primary purpose: OTHER

Brief summary: The PRAETORIAN score predicts defibrillation test success in subcutaneous ICD implantation but can only be calculated after the procedure. This pilot study aims to evaluate the feasibility of determining the PRAETORIAN score intraoperatively. Lead-to-sternum distance and generator position measurments during the implantation procedure will be evaluated. Ten consecutive patients scheduled for S-ICD implantation will be enrolled. The study involves no deviation from standard implantation procedures and requires no follow-up beyond standard post-operative chest X-ray on day one.

Detailed description: The PRAETORIAN score is an established tool to predict defibrillation test success in subcutaneous ICD implantation but can only be calculated post-procedure using chest X-ray. This pilot study aims to evaluate the feasibility of determining the PRAETORIAN score intra-operatively. This pilot study will assess whether lead-to-sternum distance and generator position can be accurately measured during the implantation procedure by manual measurements with non-fluoroscopic means. This would potentially allow risk stratification before intra-operative defibrillation testing. Ten consecutive patients scheduled for S-ICD implantation will be enrolled. The study involves no deviation from standard implantation procedures and requires no follow-up beyond standard post-operative chest X-ray on day one. If successful, this approach could improve implantation safety by identifying high-risk patients before defibrillation testing.

Eligibility criteria: Inclusion Criteria:

* consecutive patients presenting for S-ICD implantation at our institution

Exclusion Criteria:

* patients unable to consent.
* pregnancy

Primary outcomes:
measure: PRAETORIAN
timeFrame: 1 day after the device implantation, when chest x-ray is available
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital Cologne
state: NRW
Study officials:
References:
Clinical trial NCT02795000: Development a Predictive Nomogram for Primary Ovarian Insufficiency
Official title: Development a Predictive Nomogram for Primary Ovarian Insufficiency
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Ovarian Insufficiency
Keywords: Primary Ovarian Insufficiency
nomogram
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2016-06-09
Enrollment: 260
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be recruted from gynaecology department clinic of GuangDong provincial hospital of Chinese Medicine and web advertisement from April 2016 and December 2018.

Brief summary: The purpose of this research is to develop a predictive nomogram for primary ovarian insufficiency.

Detailed description: Many researches show primary ovarian insufficiency(POI) etiology is related with gene,immunization,iatrogenic, infection factors and social factors etc. In fact, approximate 70-90% POI have no definite cause, so a lot of patients don't know what will happen when they in occult stage of POI. In this research, researchers will investigate all possible factors in POI patients and normal women and select the valuable risk factor by integrated by statistical method to establish the reasonable predictive model.

This study consists two stages.The fist stage is the model establishment, the second stage is the certificate and evaluate the model.

Eligibility criteria: Inclusion Criteria:

* Age18--42
* Definite spontaneous last menstrual period
* Informed consent for participating this research and could answer the questionnaires faithfully.

Exclusion Criteria:

* Congenital gonadal dysgenesis and non organic diseases lead to menstrual disorders.
* Endocrine diseases such Polycystic ovary syndrome, hyperprolactinemia, dysfunctional uterine bleeding, low gonadotropin menstrual disorders and hyperthyreosis
* Reproductive toxicity of drugs used
* Release of chemotherapeutic drugs
* Accept sex hormone medicine in recent 3 months
* Pregnant and lactating women
* With serious heart, liver, kidney and other diseases
* With severe psychiatric disorders

Primary outcomes:
measure: Draw the Primary Ovarian insufficiency normogram
timeFrame: 1years
Secondary outcomes:
measure: Verify and evaluate the evaluation of Primary Ovarian insufficiency normogram
timeFrame: 2years
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: Guangdong provicial hospital of Chinese Medicine
state: Guangdong
Study officials:
affiliation: Guangzhou University of Traditional Chinese Medicine
name: hongyan Yang, professor
role: STUDY_CHAIR
References:
Clinical trial NCT00559000: The Efficacy of KIDNET in the Treatment of Traumatized Refugee Children in Germany
Official title: The Efficacy of KIDNET in the Treatment of Traumatized Refugee Children in Germany
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: PTSD
Keywords: PTSD
Children
trauma-focused Treatment
KIDNET
Narrative Exposure Therapy for Children
Lead sponsor: University of Konstanz
Sponsor class: OTHER
Collaborators: name: European Refugee Fund
name: German Research Foundation
First posted: 2007-11-16
Enrollment: 25
Sex: ALL
Minimum age (years): 7
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the effectiveness of KIDNET in treating traumatized refugee children in Germany


Eligibility criteria: Inclusion Criteria:

* refugee children
* age range: 7-16
* PTSD-Diagnosis

Exclusion Criteria:

* none

Primary outcomes:
measure: PTSD-Symptoms according to the UCLA Child PTSD INDEX
timeFrame: 1-month, 6-months, 12-months
Secondary outcomes:
measure: Cognitive Performance according to SPM, CPM, Rey-Figure-Test, d2; Other mental health disorders according to M.I.N.I.-KID
timeFrame: 6-months, 12-months
Other outcomes:
Locations:
city: Reichenau-Lindenbühl
country: Germany
facility: University of Konstanz, Research and Outpatient Clinic for Refugees
Study officials:
affiliation: University of Konstanz
name: Thomas Elbert, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Konstanz
name: Martina Ruf, Dipl.-Psych.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03071900: CTC Detection Rate in SCCHN With a in Vivo Device
Official title: Enumeration and Molecular Characterization of Circulating Tumor Cells (CTCs) Using a in Vivo Device in Squamous Cell Carcinoma of Head and Neck (SCCHN)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Circulating Tumor Cell
Squamous Cell Carcinoma of the Head and Neck
Lead sponsor: Nanjing Tongren Hospital
Sponsor class: OTHER
First posted: 2017-03-07
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Detection rate and isolation yield of CTC is low in squamous cell carcinoma of head and neck (SCCHN) with in vitro approaches rely on limited sample volumes. In this study, we applied a new method, the CellCollector, which could capture CTC in vivo from peripheral blood.


Eligibility criteria: Inclusion Criteria:

* SCCHN confirmed with clinical examination
* Have agreed to undergo CTC analysis in vivo;
* ECOG：0-2

Exclusion Criteria:

* the other cancer types

Primary outcomes:
measure: CTC isolation
timeFrame: 9 month
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Tongren Hospital
state: Jiangsu
Study officials:
References: