louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06204835: ITGA6 Targeting NIR-II Fluorescence Image Guided Surgery
Official title: ITGA6 Targeting NIR-II Fluorescence Image Guided Surgery of HCC Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Hepatocellular Carcinoma
Lead sponsor: Institute of Automation, Chinese Academy of Sciences
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In this study, the investigators will detect hepatocellular carcinoma lesions using fluoescence imaging with ITGA6 targeting probes during tumor resection surgery. The aim is to evaluate wether intraoperative fluorescence imaging targeting ITGA6 can help to improve the detction effect of hepatocellular carcinoma, and finally help the accurate surgical resection.

The main purposes of this study include:

1. To raise the detection rate of hepatocellular carcinoma intraoperatively using the novel NIR-II fluorescence molecular imaging and the ITGA6 targeting probe.
2. To validate the safety and effectiveness of the proposed ITGA6 targeting probes for clinical application.


Eligibility criteria: Inclusion Criteria:

1. Patients who have been diagnosed with hepatocellular carcinoma.
2. Planned to receive hepatectomy.
3. Liver function Child-Pugh A.
4. ITGA6 was validated highly expressed preoperatively.
5. Aged 18 to 80, and the expected lifetime is longer than 6 months.
6. Approved to sign the informed consent.

Exclusion Criteria:

1. Allergic to Cy7.
2. Enrolled in other trials in the past 3 months.
3. Another malignant tumor was found.
4. Undesirable function of heart, lung, kidney, or any other organs.
5. Unable to tolerate a hepatectomy.
6. The researchers considered inappropriate to be included.

Primary outcomes:
measure: HCC lesions
timeFrame: During hepatocellular resection surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong
state: Guangdong
city: Luzhou
country: China
facility: Sichuan
state: Sichuan
Study officials:
affiliation: Institute of Automation, Chinese Academy of Sciences
name: Zhenhua Hu, Ph. D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01988935: Integrated PTSD and Smoking Treatment
Official title: Integrated PTSD and Smoking Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Traumatic Stress Disorder
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2013-11-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Research shows that people with PTSD are more likely to smoke than people without PTSD. It also shows that people with PTSD have more difficulty at attempts to quit smoking. This study is part of a program aimed at finding out how best to help smokers quit who also have PTSD. One option is to give patients standard smoking cessation treatment including nicotine replacement and cognitive behavioral therapy. Another option is to give patients the standard smoking cessation treatment in addition to treatment for their PTSD symptoms (called prolonged exposure). However, it is not known which method works better. In order to answer this question, patients will be assigned by chance to one of two groups. One group will be given standard smoking cessation treatment to help quit smoking. A second group will be given the standard smoking cessation intervention to help quit smoking in addition to a form of psychotherapy called Prolonged Exposure to reduce symptoms of PTSD. The patients will be randomly assigned (by chance) to one of these groups. If the patient is assigned to the smoking cessation only condition and the patient still has PTSD symptoms after the last study visit (week 30) the patient will be offered treatment for your PTSD symptoms (Prolonged Exposure) at no cost. The patient's participation will help the investigators determine if treating PTSD symptoms enhances the ability of standard smoking cessation to help people quit smoking.


Eligibility criteria: Inclusion Criteria:

* You have PTSD
* You currently smoke more than 8 cigarettes per day
* You have a motivation to quit smoking
* You are between the age of 18 and 65.

Exclusion Criteria:

* You are currently using other tobacco products (other than cigarettes)
* You have any history of a suicide attempt, or are at significant risk of self-harm or harm to others
* You have severe depression
* You have any history of bipolar disorder, psychotic disorder
* You have a diagnosis of eating disorder, or substance abuse or dependence (excluding nicotine) within the past six months
* You are currently receiving other treatment specifically for PTSD or smoking cessation
* You are unable to read and speak English (as the materials are provided in English)

Primary outcomes:
measure: Smoking Status
timeFrame: 3 months
Secondary outcomes:
measure: PTSD Symptoms
timeFrame: 3 months
measure: General Mood and Anxiety Symptoms
timeFrame: 3 months
measure: Side Effects
timeFrame: 3 months
Other outcomes:
Locations:
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
Study officials:
References:
Clinical trial NCT04001335: Diagnosis of Cutaneous Leishmaniasis Using the CL-detect Rapid Test in Travelers and Migrants in Belgium
Official title: Diagnosis of Cutaneous Leishmaniasis Using the CL-detect Rapid Test in Travelers and Migrants in Belgium
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cutaneous Leishmaniases
Lead sponsor: Institute of Tropical Medicine, Belgium
Sponsor class: OTHER
First posted: 2019-06-28
Enrollment: 6
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with suspicion of CL will be screened for inclusion.

Brief summary: Cutaneous Leishmaniasis (CL) is a neglected tropical disease which is increasingly seen in travelers and migrants evaluated in travel clinics of non-endemic countries. Various CL species are present in different parts of the world, and these different species vary in severity, prognosis and therapeutic approaches.

At ITM, diagnosis of CL in suspected patients is done using a skin biopsy, analyzed by diagnostic PCR, and species typing PCR. This method is invasive, and diagnosis is often delayed for days to weeks.

The new antigen-based CL Detect Rapid Test uses dental broach sampling and has results within 30 minutes. Dental broach samples left over from the Cl Detect Rapid test may still be used for PCR including species typing.

How well the CL Detect Rapid Test performs in the varied population of a travel clinic and whether it is possible to use dental broach sampling for further PCR tests in this population needs to be evaluated The aim of this study is to study the performance of the CL Detect Rapid Test and whether dental broach sampling can replace skin biopsy for CL at ITM.


Eligibility criteria: Inclusion Criteria:

* Skin biopsy for leishmania test requested by treating ITM clinician OR
* externally requested skin biopsy for Leishmania tested at ITM with an ITM consultation \<7 days of the biopsy sample
* willing and able to provide consent/assent
* not on CL treatment

Primary outcomes:
measure: Diagnostic accuracy of CL detect RDT
timeFrame: 2019-2010
Secondary outcomes:
measure: Proportion of PCR positives on dental broach sample
timeFrame: 2019-2020
measure: Proportion of successful species typing on dental broach sample
timeFrame: 2019-2020
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Institute of Tropical Medicine
Study officials:
affiliation: Institute of Tropical Medicine
name: Saskia van Henten, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Tropical Medicine
name: Johan van Griensven, MD,PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06371235: Study of the Transmission of Anti-interferon Type 1 Alpha Autoantibodies From Mother to Child Via the Placental Barrier
Official title: Study of the Transmission of Anti-interferon Type 1 Alpha Autoantibodies From Mother to Child Via the Placental Barrier
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Woman Suffering From a Pathology Frequently Associated With the Presence of These Anti-autoantibodies Type-I Interferons
Lead sponsor: CerbaXpert
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 250
Sex: FEMALE
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 main objective of the study is to evaluate the frequency of placental transfer of self-Ab directed against the mother's IFN alpha in the newborn, in all women suffering from a pathology frequently associated with the presence of these autoantibodies and in those seropositive during the pregnancy.


Eligibility criteria: Inclusion Criteria:

* Pregnant woman over 18 years old
* Woman whose gestational age is less than 30 weeks.
* Having agreed to carry out an assay of anti-IFN alpha IgG auto-Ac before 30 weeks
* Give birth in the inclusion center
* Suffering from a pathology frequently associated with the presence of these anti-autoantibodies IFN alpha (lupus, severe COVID-19, myasthenia gravis, incontinentia pigmenti, hypoparathyroidism, adrenal insufficiency, diffuse candidiasis, Biermer's disease, dysthyroidism, type 1 diabetes, celiac disease, auto-thyroid disease immune system such as Graves' disease, Hashimoto's thyroiditis) or knowing its positive anti-IFN alpha autoantibody status
* Affiliated with the Social Security system

Exclusion Criteria:

* Patient who underwent a blood transfusion less than 2 months ago
* Patient who received an organ transplant
* Patient undergoing immunotherapy, stem cell therapy and/or other malignancy maternal, under heavy treatment (chemotherapy) less than 6 months before inclusion

Primary outcomes:
measure: Frequency of placental transfer of self-Ab directed against IFN alpha from mother to newborn.
timeFrame: 30 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03790735: The MDA Test to Differentiate of Benign and Malignant Pulmonary Nodules
Official title: Targeted Chromosomal Aberrations Detection by FISH Analysis of Circulating Abnormal Cells to Differentiate of Benign and Malignant Pulmonary Nodules
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Nodule, Solitary
Keywords: pulmonary nodule
Lead sponsor: Tianjin Medical University Cancer Institute and Hospital
Sponsor class: OTHER
Collaborators: name: Zhuhai livzon cynvenio diagnostics LTD
First posted: 2019-01-02
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 200 participants

Brief summary: * The purpose of the study is the identification of the efficacy of MDA Test to Differentiate of Benign and Malignant Pulmonary Nodules.
* In this study, the investigators are going to validate the efficacy of the MDA test for diagnosing early lung cancer by comparing results of the pre-surgery MDA test with the post-surgery pathology.

Detailed description: * Current state-of-the-art lung cancer early screening utilizes low-dose CT scan to identify lung nodules smaller than 3 cm in diameter. However, it's still a clinical challenge to differentiate between malignant and benign nodules.
* This study is being conducted to evaluate the efficacy of the MDA TEST to detect Targeted chromosomal aberrations in circulating abnormal cells by FISH analysis that might be an early indicator of lung cancer. Approximately 200 Pre-surgery adult patients with single pulmonary nodule found by CT scan, will be enrolled in the study. The sample type of MDA test is Peripheral Blood. This study will compare the results of the pre-surgery MDA Test with the post-surgery pathology to determine if the test can detect lung cancer or the lack of lung cancer .
* The results of the test will not be provided to the subject, the investigator and will not be used to diagnose or treat the subject.

Eligibility criteria: Inclusion Criteria:

* 18 years old or above
* single pulmonary nodule found by CT scan.
* the diameter of the pulmonary nodule is between 5mm to 30mm.
* plan to accept pneumonectomy due to the pulmonary nodule.
* agree to sign informed consent

Exclusion Criteria:

* fail to understand or agree to sign informed consent.
* pregnant or lactating women.
* the diameter of the pulmonary nodule is more than 30mm.
* there are 2 or more pulmonary nodules in one single patient.

Primary outcomes:
measure: Early detection of lung cancer
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
Study officials:
affiliation: Tianjin Medical University Cancer Institute and Hospital
name: Changli Wang, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01844635: Randomised Study Comparing Different Dosages of Rabbit ATG in Patients With SAA
Official title: A Prospective Randomized Multicenter Study Comparing Different Dosages of Rabbit Antithymocyte Globulin (Thymoglobuline) in Patients With Severe Aplastic Anemia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Acquired Aplastic Anemia.
Lead sponsor: Nagoya University
Sponsor class: OTHER
First posted: 2013-05-01
Enrollment: 320
Sex: ALL
Maximum age (years): 69
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the feasibility and effectiveness of immunosuppressive therapy (IST) using rabbit anti-thymocyte globulin (ATG) (Thymoglobuline, Genzyme) for patients with very severe aplastic anemia (VSAA) and severe aplastic anemia (SAA) as a primary therapy. The primary endpoint is the response rate (complete response (CR) + partial response (PR)) at day 180 after the start of IST. Secondary endpoints include evaluation of the presence and frequency of Epstein-Barr virus (EBV)-reactivation and EBV-associated lymphoproliferative disorder (EBV-LPD), Cytomegalovirus(CMV)-reactivation and CMV associated diseases, the response rate (CR+PR) on Day 360 after the start of IST, relapse rate and overall survival.


Eligibility criteria: Inclusion Criteria:

* Acquired aplastic anemia
* Age: younger than 70 years old
* Severity: SAA, VSAA.
* Interval between diagnosis and registration \<6 months.
* Written informed consent from the caretakers and/or whenever possible consent from the patient.

Exclusion Criteria:

-

Primary outcomes:
measure: Hematologic response (complete response (CR) or partial response (PR)) in patients with immunosuppressive therapy (IST) on day 180 after the start of IST.
timeFrame: day 180 after the start of IST
Secondary outcomes:
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Department of Pediatrics, Nagoya University Graduate School of Medicine
state: Aichi
Study officials:
affiliation: Department of Pediatrics, Nagoya University Graduate School of Medicine
name: Seiji Kojima, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01357135: An Observational Study of Type II Diabetics Treated With Dual Therapy With or Without Sitagliptin (Januvia®/Xelevia®, MK-0431-201)
Official title: Observational Study of the Treatment and Follow-up of Patients With Type II Diabetes Receiving Bitherapy With or Without Sitagliptin (Januvia®/Xelevia®).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-05-20
Enrollment: 3453
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with type II diabetes mellitus receiving a de novo prescription (for the first time or within less than 8 weeks) for dual therapy with or without Januvia®/Xelevia® or any other treatment regimen including Januvia®/Xelevia® by general practitioners in private practice under real life conditions without any additional treatment or monitoring procedures.

Brief summary: This is an observational study to compare the effectiveness of dual therapy of Type II diabetes mellitus with metformin + sitagliptin versus metformin + a sulfonylurea in routine clinical practice in France.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes participants
* De novo treatment (first prescription or dated within the past 8 weeks) with:
* Metformin + sitagliptin dual therapy,
* Metformin + sulfonylurea dual therapy,
* Sitagliptin as part of another treatment regimen
* Participants also eligible for treatment with sitagliptin (Januvia®/Xelevia®) or a sulfonylurea.

Primary outcomes:
measure: Median Duration (in Months) of Initial Dual Therapy
timeFrame: Up to 3 years
measure: Percentage of Participants With Strict Changes in Initial Dual Therapy
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Valensi P, de Pouvourville G, Benard N, Chanut-Vogel C, Kempf C, Eymard E, Moisan C, Dallongeville J. Treatment maintenance duration of dual therapy with metformin and sitagliptin in type 2 diabetes: The ODYSSEE observational study. Diabetes Metab. 2015 Jun;41(3):231-8. doi: 10.1016/j.diabet.2015.03.007. Epub 2015 May 12.
Clinical trial NCT01389635: Abdominoplasty Under Epidural Anesthesia
Official title: Abdominoplasty Under Epidural Anesthesia: Safer for the Patient, Easier for the Surgeon.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominoplasty
Keywords: Abdominoplasty
Epidural
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2011-07-08
Enrollment: 31
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients that underwent abdominoplasty between January 2003 and March 2008 in a private hospital by Dr. Yitshak Ramon.

Brief summary: Abdominoplasty is one of the most popular body-contouring procedures, yet it is also among the most hazardous aesthetic procedures currently performed. It was shown, in many studies, to be associated with a significant complication rate, some of which are life-threatening. This study describes the investigators experience with a series of abdominoplasties performed under epidural anesthesia. Outcomes are presented, especially in terms of complication, and the practical advantages of this method are discussed.


Eligibility criteria: Inclusion Criteria:

* All patients that underwent abdominoplasty between January 2003 and March 2008 in a private hospital by Dr. Yitshak Ramon.

Exclusion Criteria:

* Patients with concurrent operations requiring general anesthesia.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Elisha Medical Center
Study officials:
affiliation: Plastic Surgery Department, Rambam Healthcare Campus
name: Yitshak Ramon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03223935: Roasted Pulse Snacks, Post-prandial Food Intake, Appetite, and Glycemia
Official title: A Comparison of Roasted Pulse Snacks on Post-prandial Food Intake, Appetite, and Glycemic Response in Healthy Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Normal Weight
Overweight
Normoglycemic
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Saskatchewan Pulse Growers
name: Pulse Canada
First posted: 2017-07-21
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, controlled cross-over acute trial
Primary purpose: OTHER

Brief summary: An investigation on the effects of roasted pulse snacks on post-prandial glycemic and satiety response in healthy young adults.

Detailed description: An acute, randomized, controlled cross-over trial examining the post-prandial glycemic and satiety response to six snacks will be conducted. The study treatments are: 1) roasted corn nuts, 2) roasted chickpeas, 3) roasted yellow peas, 4) roasted pinto beans 5) roasted soybeans, and 6) roasted almonds. They will be matched for calorie content and provided in 200 kcal servings.

Eligibility criteria: Inclusion Criteria:

* BMI: ≥18.5 and ≤29.9 kg/m2
* Fasting serum glucose: ≤5.5 mmol/L

Exclusion Criteria:

* Fasting serum glucose \> 5.5 mmol/L
* Smoking
* Thyroid problems
* Previous history of cardiovascular disease, diabetes, liver or kidney disease, inflammatory bowel disease, celiac disease, short bowel syndrome, any malabsorptive syndrome, pancreatitis, gallbladder or biliary disease
* Presence of a gastrointestinal disorder or surgeries within the past year
* Consuming prescription or non-prescription drug, herbal or nutritional supplements known to affect blood glucose or that could affect the outcome of the study as per investigator's judgment
* Known to be pregnant or lactating
* Known intolerance, sensitivity or allergy to any ingredients in the study products.
* Extreme dietary habits (i.e. Atkins diet, very high protein diets, etc.)
* Uncontrolled hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg)
* Weight gain or loss of at least 10lbs in previous three months
* Excessive alcohol intake
* Restrained Eaters (identified by Eating Habits Questionnaire)

Primary outcomes:
measure: Food intake
timeFrame: At 60 min
Secondary outcomes:
measure: Subjective appetite
timeFrame: 0-200 min
measure: Blood glucose concentrations
timeFrame: 0-200 min
measure: Physical comfort
timeFrame: 0-200 min
measure: Energy and fatigue
timeFrame: 0-200 min
measure: Palatability of meal
timeFrame: At 60 min
measure: Palatability of treatment
timeFrame: At 5 min
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Peter JH Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References: