louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06636890: Correlation Analysis of Xpert Carba-R Detection of Non-colonized CRE in BALF and Rectal Swabs From Patients With LRTI
Official title: Correlation Analysis of Xpert Carba-R Detection of Non-Colonized Carbapenem-Resistant Enterobacteriaceae in Bronchoalveolar Lavage and Rectal Swabs From Patients With Lower Respiratory Tract Infections
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Carbapenem-Resistant Enterobacteriaceae
Lower Respiratory Tract Infections
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population description specifies individuals diagnosed with LRTI (Lower Respiratory Tract Infection) who were enrolled based on culture-confirmed CRKP（Carbapenem-resistant Klebsiella pneumoniae）.

Brief summary: Assess the correlation between Xpert Carba-R detection of carbapenemase gene types in bronchoalveolar lavage samples and rectal swab samples from non-colonized CRKP patients with lower respiratory tract infections, and evaluate the relationship between first-time lower respiratory tract infections and intestinal colonization of CRKP.


Eligibility criteria: Inclusion Criteria:

* Aged 18 years and above
* CRKP is cultured from lower respiratory tract specimens in 15 days
* Lower respiratory tract infection based on at least two of the followings: abnormal temperature (body temperature greater than 38.5°C or less than 36.5°C), leucocyte count abnormality (leucocyte count greater than 10\*10\^9/L or less than 4\*10\^9/L), and the presence of purulent tracheal secretions.

Exclusion Criteria:

* There are other bacteria that can produce carbapenemases exist in lower respiratory tract specimens
* Infected with CRE before

Primary outcomes:
measure: The detection of the carbapenemase gene types produced by Klebsiella pneumoniae in rectal swabs and BALF by Xpert Carba-R
timeFrame: Up to 2 weeks after each enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: he First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
References:
Clinical trial NCT04374890: Evaluation of a New Supporting Ostomy Product
Official title: Evaluation of a New Supporting Ostomy Product
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stoma Ileostomy
Lead sponsor: Coloplast A/S
Sponsor class: INDUSTRY
First posted: 2020-05-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The aim of the study is to evaluate if the new supporting product influences wear time. It is the expectation that median wear time is slightly reduced in the period when subjects are using the supporting product with their ostomy appliance. Long-term benefits of the test product may be less skin redness, less worry of leakage and/or improvement in quality of life and social activities.


Eligibility criteria: Inclusion Criteria:

1. Have given written informed consent
2. Be at least 18 years of age and have full legal capacity
3. Have had a stoma for more than three months
4. Have intact skin on the area used in the evaluation meaning no broken skin and only minor discoloration of the skin (assessed by investigator)
5. Be able to use one of the three test products (i.e. Ø50, Ø60 and Ø70 mm)
6. Have an ileostomy- or colostomy with liq-uid output (Bristol scale type 6-7)
7. Currently using a SenSura Mio product (1pc/2pc Flat/Convex/Concave)
8. Be willing and suitable (determined by the study nurse) to use the test product with-out using a paste/mouldable ring during the test periods
9. Have self-reported problems with leakage\* (three times within 14 days) \*Leakage: Leakage is defined as output from the stoma on the backside of the baseplate (underneath the baseplate)

Exclusion Criteria:

1. Currently receiving or have within the past 2 month received radio- and/or chemotherapy
2. Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment
3. Are pregnant or breastfeeding
4. Participating in other interventional clinical investigations or have previously participat-ed in this investigation. Exception: Participation in other Coloplast sponsored clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this (CP308) protocol
5. Known sensitivity towards test product
6. Known sensitivity towards acrylate
7. Users with a pacemaker

Primary outcomes:
measure: Wear time
timeFrame: 9 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Humlebæk
country: Denmark
facility: Coloplast A/S
Study officials:
References:
Clinical trial NCT03671590: Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies
Official title: A Phase 1 Pharmacokinetic and Pharmacodynamic Study of TG-1701, an Irreversible Bruton's Tyrosine Kinase Inhibitor, in Patients With B-Cell Malignancies
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Non Hodgkin Lymphoma
Chronic Lymphocytic Leukemia
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-09-14
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase 1 trial to evaluate the safety, pharmacokinetics and efficacy of TG-1701, a Bruton's Tyrosine Kinase (BTK) inhibitor in patients with relapsed or refractory B-cell malignancies.

Detailed description: This Phase I clinical trial aims to evaluate the safety of the investigational drug TG-1701 both as a single-agent and in combination with other investigational drugs, specifically ublituximab and umbralisib. As per protocol v6.0, combination therapy (TG-1701 + Ublituximab + Umbralisib) will be discontinued and the participants from Arm 1 and 2 will be transitioned to the long-term extension period to receive TG-1701 monotherapy.

Eligibility criteria: Inclusion Criteria:

* Relapsed or refractory histologically confirmed B-cell lymphoma or CLL
* Eastern Cooperative Oncology Group (ECOG) score of 0 to 2
* Adequate organ function

Exclusion Criteria:

* Prior therapy with a BTK inhibitor (ibrutinib, acalabrutinib, other)
* Any major surgery, chemotherapy or immunotherapy within the last 21 days
* Known hepatitis B virus, hepatitis C virus or HIV infection

Primary outcomes:
measure: Maximum Tolerated Dose acceptable for participants
timeFrame: From first dose up to 30 days post last dose (Up to approximately 4.8 years)
Secondary outcomes:
measure: Overall Response Rate
timeFrame: Up to approximately 4.8 years
Other outcomes:
Locations:
city: East Melbourne
country: Australia
facility: TG Therapeutics Investigational Trial Site
state: Victoria
city: Fitzroy
country: Australia
facility: TG Therapeutics Investigational Trial Site
state: Victoria
city: Nedlands
country: Australia
facility: TG Therapeutics Investigational Trial Site
state: Western Australia
city: Adelaide
country: Australia
facility: TG Therapeutics Investigational Trial Site
city: Kraków
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Lublin
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Warszawa
country: Poland
facility: TG Therapeutics Investigational Trial Site
city: Wrocław
country: Poland
facility: TG Therapeutics Investigational Trial Site
Study officials:
affiliation: St. Vincents Hospital
name: Constantine S. Tam, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01093690: Ondansetron Plus Dexamethasone With or Without Metoclopramide as Antiemetic Prophylaxis After Receiving Cisplatin
Official title: Randomized, Placebo-controlled Trial of Ondansetron Plus Dexamethasone With or Without Metoclopramide as Antiemetic Prophylaxis in Patients Receiving High Dose Cisplatin in Routine Medical Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: chemotherapy induced nausea and vomiting, metoclopramide
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Siriraj Hospital
First posted: 2010-03-26
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to assess the efficacy and tolerability of metoclopramide added to standard antiemetic regimen for prophylaxis of cisplatin-induced emesis.

Detailed description: Ondansetron plus dexamethasone are standard emetic prophylactic agents for highly emetogenic chemotherapy. Metoclopramide is a dopamine antagonist, which may enhance efficacy of ondansetron and dexamethasone.

Eligibility criteria: Inclusion Criteria:

* schedule to receive first cycle of cisplatin \> 50 mg/m\^2
* pathologically or histologically confirmed solid cancer
* more than 18 years old
* creatinine clearance more than 50 ml/min
* aminotransferase less than 2 times of upper normal limit

Exclusion Criteria:

* pregnant woman
* patients with episode of vomiting within 24 hours prior to chemotherapy session
* gut obstruction
* brain metastasis
* abdominal or pelvic irradiation
* no history of allergy to study drugs

Primary outcomes:
measure: Number of Patients Who Had Complete Response
timeFrame: 5 days after receiving chemotherapy
Secondary outcomes:
measure: Toxicities and Severity of Nausea and Vomiting
timeFrame: 5 days after receiving chemotherapy
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Division of medical oncology, department of medicine Siriraj Hospital
Study officials:
affiliation: Siriraj Hospital
name: Suthinee Ithimakin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04757090: 89Zr-Trastuzumab PET/CT in Subjects With Previously Treated HER2-Positive Solid Tumors Scheduled to Receive Treatment With MT-5111
Official title: A Pilot Study of 89Zr-Trastuzumab PET/CT in Subjects With Previously Treated HER2-Positive Solid Tumors Scheduled to Receive Treatment With MT-5111
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: HER2-positive Solid Tumor
HER-2 Positive Cancer
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Molecular Templates, Inc.
First posted: 2021-02-16
Enrollment: 0
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: This is an open-label, single center, pilot study to assess the feasibility of baseline 89Zr-trastuzumab PET/CT to predict response to treatment with monotherapy MT-5111


Eligibility criteria: Inclusion Criteria:

* Must meet eligibility criteria and be registered to receive treatment under Protocol MT-5111_001 (WU HRPO # 201907092).
* Must have at least one measurable lesion by RECIST 1.1 during the dose expansion phase of MT-5111_001. Osteosarcoma subjects with evaluable (e.g., bone-only) disease may be included.
* Must have standard of care 18F-FDG-PET/CT within 90 days before administration of 89Zr-trastuzumab OR be willing to undergo 18F-FDG PET/CT scan for research purposes.
* Able to undergo PET/CT imaging
* Able to understand and willing to sign an IRB-approved written informed consent document.

Exclusion Criteria:

* Hepatic only disease
* Pregnant or breastfeeding.

Primary outcomes:
measure: Average 89Zr-trastuzumab SUVmax of lesions identified on baseline FDG-PET/CT
timeFrame: At baseline
Secondary outcomes:
measure: Average 89Zr-trastuzumab tumor-to-normal tissue uptake ratio of lesions identified on baseline FDG-PET/CT
timeFrame: At baseline
measure: Average 89Zr-trastuzumab tumor-to-blood uptake ratio of lesions identified on baseline FDG-PET/CT
timeFrame: At baseline
measure: Intra-patient 89Zr-trastuzumab tumor uptake heterogeneity in patients with multiple lesions (fractions of scan-positive and scan-negative lesions)
timeFrame: At baseline
Other outcomes:
Locations:
Study officials:
affiliation: Washington University School of Medicine
name: Brian A Van Tine, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02875990: Characterization of Immunosuppressive Signing of Cervical Cancer
Official title: Characterization of Immunosuppressive Signing of Cervical Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervical Cancer
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Infection with Human Papillomavirus high-risk Human (HR-HPV) is the main factor of risk of cancer of the cervix. Recent studies show that cancers linked to infection with HR-HPV are associated with immunosuppression and lack of T cell response Such mechanisms would promote progression to cancer and progression of it . Various factors such as an increase of regulatory T cells, the presence of myeloid cells and suppressor of defects in the signaling pathway Toll Like Receptor (TLR) may have a key role in these immunosuppression mechanisms. At this stage of knowledge, a better characterization of local and systemic immunosuppressive signing of cervical cancer is needed. The results should have a significant medical impact for the identification of new prognostic markers and new therapeutic targets for the treatment of patients with cervical cancer.

The aim of this research project is to define the signing of immunosuppressive cancer cervix and analyze the different mechanisms involved in this immunosuppression.


Eligibility criteria: Inclusion Criteria:

* The women presenting for initial therapeutic management of cervical cancer
* Elderly patients over 18 years
* Patients beneficiary of a social security scheme
* Pregnant women can not participate in this study
* Women known to be HIV positive will not participate in this study

Exclusion Criteria:

* Patients with a recurrence of a treaty cervical cancer
* Patients with a history of pelvic radiotherapy
* Patients unable to receive informed about the progress and objectives of the study
* Patients not receiving a social security scheme
* Patients who have not signed informed consent
* Immunocompromised patients and pregnant women

Primary outcomes:
measure: Lack of tumor emboli histological analysis
timeFrame: 60 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
References:
Clinical trial NCT05501990: Study on the Accessibility and Feasibility of Intelligent Applet for Health Intervention of Cancer Patients
Official title: Study on the Accessibility and Feasibility of Intelligent Applet for Health Intervention of Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In the 5G era with the revolutionary improvement of network speed, digital medical care has brought great convenience to health services. There is a lack of mobile medical data on cancer care worldwide. We designed an applet based on mobile intelligent electronic devices with a doctor-patient dual interface for the perioperative management of cancer patients and verified its applicability in the general population. This study aims to specifically improve the applet according to the characteristics of cancer patients, use it to accurately manage and intervene cancer patients, and establish a rapid doctor-patient communication platform, hoping to improve prognosis.


Eligibility criteria: Inclusion Criteria:

* Sign and date informed consent;
* Commit to abide by the research procedures and cooperate with the implementation of the whole research process ;
* Can adhere to and cooperate with research intervention;
* Tumor patients;
* Patients/family members can use smart phones to access the Internet;
* Patients/family members have sufficient cognitive and reading ability;
* No mental illness;
* No serious visual impairment

Exclusion Criteria:

* Equipped with specific devices (such as cardiac pacemaker);
* Those who do not meet the conditions listed in the inclusion criteria.

Primary outcomes:
measure: Acceptability of the applet by cancer patients as assessed by questionnaire
timeFrame: 3 months
measure: Acceptability of the applet by medical oncology staff as assessed by questionnaire
timeFrame: 3 months
Secondary outcomes:
measure: Self-reported quality of life as assessed by ED-5Q-5L scale
timeFrame: 3 months
measure: Psychological status as assessed by the HADS scale
timeFrame: 3 months
measure: Symptom distress as assessed by the MD Anderson symptom scale
timeFrame: 3 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital，Shanghai Jiao Tong University School of Medicine
Study officials:
affiliation: Ruijin Hospital
name: Lei Huang, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00958503: Effect of Thiamphenicol on EAAT2 and Other Biomarkers From Nasal Biopsied Tissue
Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of 14-Day Repeated-Dose Administration of Thiamphenicol (RUX 122) in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: safety
biomarker
thiamphenicol
EAAT2
Lead sponsor: Psyadon Pharma
Sponsor class: INDUSTRY
Collaborators: name: SGS Life Sciences, a division of SGS Belgium NV
First posted: 2009-08-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine if two-weeks of dosing with thiamphenicol is safe and is able to change the levels of certain pre-specified biomarkers in nervous tissue taken from the nasal passages.

Detailed description: Thiamphenicol has been proposed to increase the levels of the excitatory amino acid transporter 2 (EAAT2) in the nervous tissue. This study evaluated the ability of two weeks of treatment with thiamphenicol to increase EAAT2 in a nasal biopsy as a surrogate of brain nervous tissue.

Eligibility criteria: Inclusion Criteria:

* normal volunteers

Exclusion Criteria:

* less than 18 years
* older than 55 years

Primary outcomes:
measure: Amount of EAAT2 RNA in nasal biopsy
timeFrame: Two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: SGS Research Unit - Stuivenberg
Study officials:
affiliation: Ruxton Pharmaceuticals
name: Richard E Chipokin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04322903: Passport to Freedom: Health and Housing
Official title: Passport to Freedom: Health and Housing
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Trauma
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Urban Health Institute
First posted: 2020-03-26
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of the Passport to Freedom (P2F) Health and Housing is to provide formerly homeless women a supportive group to process the impact of trauma on the women's overall health and wellbeing, learn strategies to reduce the symptoms of trauma and stress, and increased ability to cope with everyday stress while maintaining permanent housing.

Detailed description: The proposed project will use a mixed method design to examine the feasibility and effectiveness of the Passport to Freedom (P2F) Program, an intervention for formerly homeless women currently housed through a supportive permanent housing program. P2F involves: three 2-hr sessions to promote physical and emotional wellbeing through mindfulness techniques and health promotion activities; two home visits to provide individualized sessions with a nurse and a community health navigator; and a follow-up session 4 weeks after intervention to discuss the women's perception of the intervention. By the end of the program, women will have improved emotional self-regulation in response to everyday stress, positive perception of managing women's overall health, and increased confidence in maintaining stable housing.

Eligibility criteria: Inclusion Criteria:

* Women 18 years to 55 years, may be parents
* Able to read and write English
* Formerly homeless and currently living in permanent supportive housing through the Women's Housing Coalition Program.

Exclusion Criteria:

* Under 18 years of age
* Inability to speak or write English

Primary outcomes:
measure: Change in confidence in managing health as assessed by the Perceived Health Competence Scale
timeFrame: At the time of consent and 4 weeks after intervention
measure: Change in emotional response to stress as assessed by the Difficulties in Emotion Regulation Scale
timeFrame: At the time of consent and 4 weeks after intervention
measure: Change in stress as assessed by the Everyday Stressor Index
timeFrame: At the time of consent and 4 weeks after intervention
measure: Perception of the overall program as assessed by a semi-structured interview questions
timeFrame: 4 weeks after the intervention
measure: Perception of ability to maintain stable housing as assessed by a semi-structured interview questions
timeFrame: 4 weeks after the intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins School of Nursing
name: Kim Hill, MS
role: STUDY_CHAIR
References: