louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00180804: Maternal KIR and Fetal HLA-C Genes in Recurrent Miscarriages
Official title: Combination of Maternal KIR and Fetal HLA-C Genes in Recurrent Miscarriages
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Miscarriages
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: OTHER

Brief summary: For implantation of developing conceptus, placental cells need to invade mother's uterus to access maternal blood supply in a control manner. We have found a combination of maternal immune genes (the KIR family) and fetal genes (HLA-C) strongly associated with pre-eclampsia where placenta does not implant adequately. The aim of this research is to investigate these two genes family in women suffering with recurrent miscarriages and find a possible link between them.

Detailed description: Little is known about reasons for early pregnancy failures. It is believed that some pathology leading to defective implantation of fetus in maternal uterus may lead to recurrent early miscarriages. This project arises from previous work on pre-eclampsia where we found combination of maternal immune genes (KIR) with their ligand (HLA-C) in the fetus was strongly associated with the disease. We will tissue type the fetus, mother and father in cases of unexplained miscarriages. We hope that genetic findings in recurrent miscarriage will lead to new insights, prevention and treatment.

Eligibility criteria: Inclusion Criteria:

Couples with 3 or more unexplained miscarriages

Exclusion Criteria:

Previous livebirths, parental karyotypic abnormalities, thrombophilic defects, uterine structural abnormalities

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St. Mary's Hospital
Study officials:
affiliation: University of Cambridge, UK
name: Ashley Moffett, MRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: Imperial College London
name: Raj Rai, MRCOG
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Mary's NHS Trust, London
name: Preeti Jindal, MRCOG
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Mary's NHS Trust, London
name: Winnie Lo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01622504: Naloxone Nasal Spray Pharmacokinetic Study
Official title: A Phase I Single Dose, Open Label, Randomized, Three Period Crossover Pilot Study to Compare the Pharmacokinetics, Safety and Tolerability of MVP005 Intranasal Spray With Intranasal Administration of Naloxone Solution for Injection in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Opioid Overdose
Keywords: Intranasal
nasal spray
opioid
overdose
Lead sponsor: Mitovie Pharma Ltd
Sponsor class: INDUSTRY
First posted: 2012-06-19
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to compare the pharmacokinetics of naloxone when administered as the Mitovie nasal spray (Test Product) and as a solution for injection (Comparator Product) administered intranasally using a mucosal atomization device (MAD).

Detailed description: Naloxone hydrochloride is currently only recommended and licensed for intravenous, intramuscular and subcutaneous administration. It has also been used by intranasal administration (off-label use) when the intravenous route is not suitable by administering the Solution for Injection using a mucosal atomization device (MAD). However, due to the volume of naloxone solution administered this way, some of it may be inadvertently swallowed and not absorbed into the nasal mucosa and the product requires administration by medically trained personnel. The study aims to investigate intranasal administration of naloxone using a more concentrated solution and a nasal delivery device.

Eligibility criteria: Inclusion Criteria:

* Male or female
* 18-60 50 years of age
* Provide written informed consent prior to completing any study specific procedure.
* Body Mass Index (BMI) range 18.5-30 kg/m2
* Clinically acceptable medical history, clinical laboratory evaluations, complete physical examination, vital signs and 12 lead ECG
* Using reliable contraception

Exclusion Criteria:

* Intranasal problems
* Taking prescribed or over the counter medications
* Intake of alcohol, methyl-xanthines or grapefruit or strenuous exercise concurrent with treatment.

Primary outcomes:
measure: Pharmacokinetics
timeFrame: 0, 5, 10, 15, 20, 30 and 45 minutes and 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00 and 12.00 hours for each arm
Secondary outcomes:
measure: Number of subjects with adverse events
timeFrame: 14 days
measure: Physical Examination
timeFrame: 14 days
measure: Vital signs
timeFrame: 14 days
measure: ECGs
timeFrame: 14 days
measure: Safety Laboratory Tests
timeFrame: 14 days
Other outcomes:
Locations:
city: Amman
country: Jordan
facility: International Pharmaceutical Research Center (IPRC)
Study officials:
affiliation: IPRC, Jordan
name: Abdullah Hiyari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06266104: Image Enhanced Endoscopy IBD
Official title: Image Enhanced Endoscopy Technology to Improve the Detection of Colorectal Dysplasia in Patients With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Bowel Diseases
Dysplasia
Lead sponsor: Royal Perth Hospital
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Dye- spray chromoendoscopy remains the recommended gold standard approach for IBD dysplasia surveillance colonoscopy however recently published European and American guidelines recommend either dye-spray or virtual chromoendoscopy can be used for surveillance. The newer Imaged Enhanced Endoscopy technologies TXI and LCI have not formally been evaluated in IBD surveillance in a randomised controlled trial setting. These modes can easily be applied during colonoscopy and if demonstrated to be effective may save time and eliminate the need for dye-spray chromoendoscopy in the future.


Eligibility criteria: Inclusion Criteria:

* Patients with inflammatory bowel disease aged 18 to 75 years, that meet Australian recommendations to undergo surveillance colonoscopy will be identified and invited participate in the study.

Exclusion Criteria:

* Any active disease
* Inadequate bowel preparation
* Previous surgical resection involving the colon
* History of bowel cancer

Primary outcomes:
measure: Dysplasia Detection Rate
timeFrame: 2 years
Secondary outcomes:
measure: Withdrawal times
timeFrame: 2 years
measure: Characterisation of lesions
timeFrame: 2 years
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Royal Perth Hosptial
state: Western Australia
Study officials:
References:
Clinical trial NCT06362304: 99mTc-CNDG SPECT/CT in Brain Tumors
Official title: Application of 99mTc-CNDG SPECT/CT Imaging in the Diagnosis of Brain Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intracranial Tumor
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-04-12
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: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to evaluate the value of 99mTc-CNDG for diagnosis of brain tumors by comparing it with 18F-FDG-PET. The main questions it aims to answer are:

1. What is the diagnostic consistency between 99mTc-CNDG and 18F-FDG?
2. What is the correlation between the SUVmax value of 99mTc-CNDG and tumor type?

Participants will:

Receive18F-FDG-PET and 99mTc-CNDG examination within 2 weeks before surgery. Obtain pathological diagnosis by surgery or biopsy as the gold standard.


Eligibility criteria: Inclusion Criteria:

* Patients with clinical diagnosis of brain tumor;
* Be at least 18 years old;
* The final pathological results could be obtained by surgery or biopsy;
* Informed consent and the ability to be followed up;
* Those who did not meet the exclusion criteria.

Exclusion Criteria:

* Insulin-dependent diabetes mellitus or fasting blood glucose \>7 mmol/L before 99mTc-CNDG injection;
* Severe liver or kidney disease (serum creatinine level \>3.0mg/dL or any liver enzyme level ≥ 5 times the upper limit of normal);
* Severe hypersensitivity or hypersensitivity to radiocontrast agents;
* Claustrophobia (inability to undergo SPECT/CT or PET/CT scans);
* Patients receiving radiotherapy and chemotherapy;
* Being pregnant or breastfeeding.

Primary outcomes:
measure: SUVmax
timeFrame: 1month
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04931004: Oral Rinse to Reduced Expelled Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) During COVID-19 Infection
Official title: Effect of Oral Hygiene Products on Reducing Expelled/Exhaled SARS-CoV-2
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Covid19
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Colgate Palmolive
name: University of Leicester
First posted: 2021-06-18
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Prospective, cross-sectional study evaluating the effect of commercially available mouthwashes on expelled/exhaled SARS-CoV-2 viral load using face mask sampling.

Detailed description: The study will consist of a Control Phase to optimize procedures for measuring expelled/exhaled viral load, and a Evaluation phase comparing different commercially available mouthwashes.

In the Control Phase. up to 20 COVID-19 patients will be asked to undergo a sequence of face mask sampling and saliva collections prior to and after an oral rinse with (i) water and (ii) a commercially-available cetylpyridinium chloride (CPC) mouthwash.

Based on outcomes of the Control Phase, the study will proceed into the Evaluation Phase, which will randomize approximately 40 COVID-19 patients to receive 1 of 4 commercially available Colgate mouthwashes following standard package instructions. Face mask sampling and saliva will be collected prior to and after the mouth rinse to assess impact on SARS-CoV-2 viral load.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18
2. Able to provide consent
3. Polymerase chain reaction (PCR)-confirmed SARS-CoV-2 within previous 48 hours.

Exclusion Criteria:

1. Clinical contraindication or poor feasibility to complete study procedures
2. Unwilling or unable to produce saliva or face mask samples
3. Unable to produce at least 500 microliters of saliva.
4. Eaten within past 30 minutes
5. Known allergy to mouthwash products

Primary outcomes:
measure: Control Phase - Primary Endpoint
timeFrame: Single timepoint, ~1 hour
measure: Evaluation Phase - Primary Endpoint
timeFrame: Single timepoint, ~1.5 hours
Secondary outcomes:
measure: Evaluation Phase - Secondary Endpoint
timeFrame: Single timepoint, ~1 hour
measure: Comparative Saliva Reduction
timeFrame: Single timepoint, ~1.5 hours
Other outcomes:
measure: Influence of Speaking
timeFrame: Single timepoint, ~1 hour
Locations:
Study officials:
affiliation: Rutgers University
name: Yingda L Xie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers University
name: David Alland, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rutgers University
name: Padmapriya Banada, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04357704: Improved Speech Recognition Performance in Noise by Encoding Binaural Spatial Cues to the Cochlea Implant User
Official title: Improved Speech Recognition Performance in Noise by Encoding Binaural Spatial Cues to the Cochlea Implant User
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hearing Loss, Cochlear
Keywords: Iteraural Time Difference
Lead sponsor: Oticon Medical
Sponsor class: INDUSTRY
First posted: 2020-04-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to evaluate the interaural time difference (ITD) benefit in patient with bilateral cochlear implants and to assess speech performance in noisy conditions compared to normal hearing listeners. Half of participants are bilateral cochlear implants users, while the other are normal hearing listeners.

Detailed description: Listening in noisy environments is part of everyday life, it is based on binaural phenomena such as spatial localization

Bilateral cochlear implants certainly restore a part of binaurality

Eligibility criteria: Inclusion Criteria:

* Fluent in local language
* Normal hearing listener:
* pure tone threshold \> 25dB from 125Hz to 12kHz
* Cochlear implant recipient
* bilaterally implanted 6 months at least, the second implant should be implanted 6 months at least before participant inclusion
* Digisonic SP® cochlear implants user

Exclusion Criteria:

* binaural sensitivity threshold \< 1000µs

Primary outcomes:
measure: speech reception threshold (SRT) in bilateral cochlear implant user with ITD cue
timeFrame: day 0
Secondary outcomes:
measure: speech reception threshold (SRT) in bilateral cochlear implant user without ITD cue and in normal hearing listeners
timeFrame: day 0
measure: ITD sensitivity in bilateral cochlear implant user
timeFrame: day 0
measure: Preferred jitter in bilateral cochlear implant user
timeFrame: day 0
Other outcomes:
Locations:
Study officials:
affiliation: Hospital University Nice-IUFC
name: Nicolas Guevara, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital University Dijon-François Mitterrand
name: Alexis Bozorg-Grayeli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04383704: MIND Diet Intervention and Cognitive Performance
Official title: Effect of MIND Diet Intervention on Cognitive Performance and Brain Structure in Healthy Obese Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-05-12
Enrollment: 37
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This single-center, randomized trial examined the effect of MIND diet intervention on cognition and brain structure changes of healthy obese women over three months. The intervention group was lea to calorie-restricted modified by the MIND diet, and the control group received a calorie-restricted standard diet. The primary end-point was an assessment of cognitive performances measured with a comprehensive cognitive test battery. Secondary end-points were voxel-based morphometry to quantify the differences in brain structures. Our results revealed MIND diet could improve working memory, verbal recognition memory, and attention, more in comparison with the control group. Results also suggest that an increase in inferior frontal gyrus in the MIND diet group. Our study, for the first time, underlined that good adherence to the MIND diet as well as calorie restriction could reverse the destructive effect of obesity on cognition.


Eligibility criteria: Inclusion Criteria:

* Middle-aged women (40-60 years),
* Without any metabolic complication,
* BMI 30-35 kg/m2,
* MMSE ≥ 24,
* And no history of severe untreated medical, neurological, and psychiatric diseases which may interfere with the study intervention.

Exclusion Criteria:

* Have gastrointestinal problems,
* Participate in weight loss programs,
* Use weight loss drugs in the last three months,
* Had not wholly followed the dietary pattern,
* Became pregnant,
* And undergo special medical treatments during a three months study.

Primary outcomes:
measure: Assessment of changes in cognitive performance tests measured by a complex paper cognitive battery at the baseline and after three months follow up.
timeFrame: Baseline and after three months.
Secondary outcomes:
measure: Assessment of changes in brain structures measured by Magnetic Resonance Imaging (MRI) baseline and after three months follow up.
timeFrame: Baseline and after three months.
Other outcomes:
Locations:
city: Shiraz
country: Iran, Islamic Republic of
facility: Shiraz University of Medical Science
state: Fars
Study officials:
References:
citation: Arjmand G, Abbas-Zadeh M, Eftekhari MH. Effect of MIND diet intervention on cognitive performance and brain structure in healthy obese women: a randomized controlled trial. Sci Rep. 2022 Feb 21;12(1):2871. doi: 10.1038/s41598-021-04258-9.
Clinical trial NCT01895504: ColoAssist vs. MEI
Official title: ColoAssist vs. Magnetic Guided Colonoscopy - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Screening
Keywords: Colonoscopy
Colorectal cancer
Adenoma
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
First posted: 2013-07-10
Enrollment: 475
Sex: ALL
Minimum age (years): 55
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Colonoscopy aims to investigate the entire colon by advancing the colonoscope tip from the rectum to the cecum, a process called cecal intubation. Cecal intubation may be difficult for different reasons, and features of the colonoscope and the use of imaging devices may influence the success rate. We want to compare the performance of a new colonoscope with novel features including gradual stiffness with that of a colonoscope supplied with a magnetic endoscope imaging (MEI) device. The hypothesis is that the performance of the new instrument is non-inferior to the MEI system.

Detailed description: The recommended cecal intubation rate in colorectal cancer (CRC) screening is 95%. The MEI system allows real time monitoring of the colonoscope position within the colon and is considered to be a useful supplement to achieve cecal intubation. However, the MEI system is costly, and trial results are equivocal regarding the actual benefits. A newly designed colonoscope (ColoAssist) with gradual stiffness throughout the colonoscope shaft has been developed to improve insertability. We want to investigate if we can achieve equal performance results with the ColoAssist instrument as with the MEI system in CRC screening. The study is designed as a two-center, single-blinded, randomized, controlled non-inferiority trial.

Eligibility criteria: Inclusion Criteria:

* Inclusion in an ongoing colorectal cancer screening trial (NCT 00883792)

Exclusion Criteria:

* Excluded from the ongoing screening trial (NCT 00883792)
* Inability or unwilling to provide informed consent

Primary outcomes:
measure: Cecal intubation rate
timeFrame: 1 hour
Secondary outcomes:
measure: Cecal intubation time
timeFrame: 1 hour
measure: Adenoma detection rate
timeFrame: 1 hour
measure: Polyp detection rate
timeFrame: 1 hour
measure: Pain
timeFrame: 24 hours
Other outcomes:
Locations:
city: Arendal
country: Norway
facility: SSHF Arendal
city: Kristiansand
country: Norway
facility: SSHF Kristiansand
Study officials:
affiliation: SSHF Kristiansand, Norway
name: Kjetil K Garborg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oslo
name: Michael Bretthauer, PhD
role: STUDY_CHAIR
References:
citation: Garborg K, Wiig H, Hasund A, Matre J, Holme O, Noraberg G, Loberg M, Kalager M, Adami HO, Bretthauer M. Gradual stiffness versus magnetic imaging-guided variable stiffness colonoscopes: A randomized noninferiority trial. United European Gastroenterol J. 2017 Feb;5(1):128-133. doi: 10.1177/2050640616639162. Epub 2016 Jun 23.
Clinical trial NCT01770704: Observation Study of the Clinical Management of Bipolar Disorder
Official title: Chinese Observation Study of the Clinical Management of Bipolar Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder
Keywords: Bipolar disorder
Clinical management
Clinical outcomes
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2013-01-18
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with bipolar disorder I or II with at least one mood event during the 3 and 12 months prior to the beginning of the study.

Brief summary: The objective of the ambispective cohort study is to describe clinical management and clinical outcomes related to bipolar disorder in China, and establish the factors associated with different management patterns and clinical outcomes, provide psychiatrists with reliable and up-to-date information on the disease.


Eligibility criteria: Inclusion Criteria:

* Provision of subject informed consent.
* Diagnosis of Bipolar Disorder I or II (DSM-IV TR) in any phase of the disorder.
* Patients who had at least one mood event( depression, mania, hypomania or mixed) according to DSM-IV TR definition during the 3 and 12 months prior to the beginning of the study.

Exclusion Criteria:

* Inability to complete Patient Reported Outcomes (PROs) questionnaires.
* Participation in an interventional clinical study in last 12 months.

Primary outcomes:
measure: Number of episodes (depression, mania, hypomania or mixed).
timeFrame: Up to 21 months
Secondary outcomes:
measure: Treatments received for Bipolar Disorder: medication time.
timeFrame: Up to 21 months
measure: Treatments received for Bipolar Disorder: medication classes.
timeFrame: Up to 21 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Shenzhen
country: China
facility: Research Site
state: Guangdong
city: Shanghai
country: China
facility: Reserach Site
state: Shanghai
city: Xi'an
country: China
facility: Research Site
state: Shanxi
city: Kunming
country: China
facility: Research SIte
state: Yunnan
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
Study officials:
affiliation: Beijing No.6 Hospital
name: Yu Xin
role: PRINCIPAL_INVESTIGATOR
affiliation: Capital Medical University
name: Wang Gang
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang L, Yang HC, Xu XF, Fang YR, Yu X, Tan QR, Li HC, Ungvari GS, Ng CH, Wang G, Xiang YT. Demographic and clinical differences between early- and late-onset bipolar disorders in a multicenter study in China. Psychiatry Res. 2016 Dec 30;246:688-691. doi: 10.1016/j.psychres.2016.10.063. Epub 2016 Oct 30.