louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06161935: A Study of Lymph Node Metastatic Pattern Based Incorporating Tumor Location, GGO Components and Size for Non-small Cell Lung Cancer
Official title: A Retrospective Study of Lymph Node Metastatic Pattern Based Incorporating Tumor Location, GGO Components and Size for Non-small Cell Lung Cancer Involving Patients in Thoracic Surgery Fudan University Shanghai Cancer Center From April 2008 to July 2022. Data Were Analyzed From October 2022 to July 2023 to Further Elaborated the Different Nodal Metastatic Pattern in Different Tumors and Identify the Characteristics of Patient Group Without Lymph Node Metastasis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer Non Small Cell
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-12-08
Enrollment: 7067
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 7067 invasive non-small cell lung cancer patients in FUSCC who underwent pulmonary resection with systematic lymph node dissection from April 2008 to July 2022.

Brief summary: The goal of this observational study is to learn about in invasive non-small cell lung cancer patients who underwent pulmonary resection with systematic lymph node dissection from April 2008 to July 2022 . The main question it aims to answer are: determine the situation of zero risk mediastinal lymph metastases and the different lymph node metastatic patterns of tumors with different characteristics.

Participants will provide personal information to analyze. and there is not a comparison group.


Eligibility criteria: Inclusion Criteria:

* invasive non-small cell lung cancer patients in FUSCC who underwent pulmonary resection with systematic lymph node dissection from April 2008 to July 2022

Exclusion Criteria:

* none

Primary outcomes:
measure: The number of participants with no mediastinal lymph metastases after systematic lymph node dissection.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02692235: Carnitine Supplementation and Skeletal Muscle Function
Official title: Carnitine Supplementation and Skeletal Muscle Function in Aging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sarcopenia
Keywords: carnitine
Lead sponsor: Gdansk University of Physical Education and Sport
Sponsor class: OTHER
Collaborators: name: National Science Centre, Poland
First posted: 2016-02-26
Enrollment: 28
Sex: ALL
Minimum age (years): 65
Maximum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Research project objectives The primary aim of the current research project is to use carnitine supplementation as the anti-inflammatory intervention for exploring the relationship between inflammation and associated with aging reduction of skeletal muscle mass.

Hypothesis The carnitine supplementation modulates the blood cytokines concentration. Anti-inflammatory intervention delay the reduction of skeletal muscle mass associated with aging

Detailed description: Volunteers over 65 years old (n=40) are supplemented either with carnitine or placebo for 24 weeks. Before the start, in the mid-point, and after finishing the supplementation the following primary outputs variables are performed: body composition analysis (InBody720), maximal isokinetic knee extensor peak torque (Biodex System 4 Pro), blood cytokines and carnitine concentration, blood lipid profile.

Eligibility criteria: Inclusion Criteria:

* Subjects with no history of gastrointestinal disorders, cardiovascular disease or hypertension.

Exclusion Criteria:

* Subjects having any illnesses and a history of gastrointestinal disorder, cardiovascular disease, hypertension, liver and renal disease, diabetes, cancer, alcoholism or other metabolic diseases.

Primary outcomes:
measure: Blood Inflammatory Marker
timeFrame: baseline and after 24 weeks of supplementation period
Secondary outcomes:
measure: Lipid Metabolites
timeFrame: baseline and after 24 weeks of supplementation period
Other outcomes:
Locations:
city: Gdansk
country: Poland
facility: University of Physical Education and Sport
state: Pomorskie
Study officials:
affiliation: Gdansk University of Physical Education and Sport
name: Robert A Olek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03327935: Post-discharge Nutrition and Resistance Training in Surgical Patients
Official title: Malnutrition in Surgical Patients in the Faroe Islands: Post-discharge Nutrition and Resistance Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malnutrition
Surgery
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Health Insurance Fund of Research Council Faroe Islands
name: National Hospital of the Faroe Islands
name: Société des Produits Nestlé (SPN)
First posted: 2017-11-01
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 groups of 50 patients each by randomization
Primary purpose: TREATMENT

Brief summary: Randomized intervention by nutritional supplements and training in postoperative patients after discharge

Detailed description: Surgery combined with malnutrition is associated with loss of muscle mass and leads to serious consequences for the surgical patient. A majority of surgical patients continue to lose weight after discharge. Nutritional risk screening has not been fully implemented at Landssjúkrahúsið - the National Hospital of the Faroe Islands and therefore the prevalence of patients at nutritional risk is unknown. The aim of this study is to examine whether an intervention with independent nutritional supplements or an intervention combining nutritional supplements and resistance training is more effective in preventing loss of muscle mass than standard care in surgical patients following discharge. Secondary outcomes are changes in body weight, quality of life, muscle strength and activities of daily living. Furthermore, we want to screen hospitalized surgical patients for nutritional risk in order to get an estimate of the prevalence of nutritional risk.

Eligibility criteria: Inclusion Criteria:

* Admitted to the surgical departments at Landssjúkrahúsið - National Hospital of Faroe Islands
* Aged 18 years or above
* One or more of the following surgical procedures: knee alloplasty, hip alloplasty, collum femoris fracture, back fracture, abdominal surgery, mamma surgery and other comprehensive surgery
* At nutritional risk according to screening

Exclusion Criteria:

* Minimally invasive surgery/Laparoscopic surgery
* Severely reduced kidney function (p-creatinin\>250 mikromol/l) or dialysis
* Terminal illness
* Inability to cooperate in tests or exercises due to cognitive function or dementia
* Admitted to intensive care unit
* Inability to speak or understand Faroese, Danish or English
* Consent according to national regulations not obtainable

Primary outcomes:
measure: Loss of lean body mass
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tórshavn
country: Faroe Islands
facility: National Hospital of Faroe Islands
Study officials:
affiliation: University of Copenhagen
name: Jens Rikardt R Andersen
role: STUDY_CHAIR
References:
Clinical trial NCT05846035: Paraneoplastic Syndrome in Hepatocellular Carcinoma Patients
Official title: Paraneoplastic Syndrome in Hepatocellular Carcinoma Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma Patients
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: * Cirrhotic Patients with HCC.
* HCC will be diagnosed based on Alpha -feto protein (AFP) and dynamic imaging.

Brief summary: Hepatocellular carcinoma (HCC) is the sixth most common cancer in the world with rising incidence. Globally, there has been substantial variation in prevalence of risk factors for HCC over years, like control of viral hepatitis in developing countries but growing epidemic of fatty liver disease in developed world. Changing epidemiology of HCC is related to trends in these risk factors, Paraneoplastic syndromes (PNS) are defined as systemic, metabolic, or other distant consequences of malignancy resulting, either directly or indirectly, from production by the neoplasm of substances that gain access to the blood stream, thereby exerting their effects on distant organs or tissues There is four major HCC-associated paraneoplastic syndromes among Cirrhotic patients,i.e.hypercholesterolemia,hypoglycemia,hypercalcemia,and erythrocytosis .


Eligibility criteria: Inclusion Criteria:

* - Cirrhotic Patients with HCC.
* HCC will be diagnosed based on Alpha -feto protein (AFP) and dynamic imaging.

Exclusion Criteria:

* - Patient known to have primary parathyroid disease, patients with bone metastasis or excessive use of antacids.
* Patients with secondary polycythemia (as chronic hypoxia) and patients with polycythemia rubra vera.
* Patients with acute infections or GIT bleeding.
* Patients with preexisting dyslipidemia.
* Patients with significant cholestasis.

Primary outcomes:
measure: the prevalence of Paraneoplastic Syndrome in cirrhotic Patients with HCC.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University hospitals
Study officials:
References:
citation: Borde T, Nezami N, Laage Gaupp F, Savic LJ, Taddei T, Jaffe A, Strazzabosco M, Lin M, Duran R, Georgiades C, Hong K, Chapiro J. Optimization of the BCLC Staging System for Locoregional Therapy for Hepatocellular Carcinoma by Using Quantitative Tumor Burden Imaging Biomarkers at MRI. Radiology. 2022 Jul;304(1):228-237. doi: 10.1148/radiol.212426. Epub 2022 Apr 12.
citation: Qu Q, Wang S, Chen S, Zhou L, Rui JA. Prognostic role and significance of paraneoplastic syndromes in hepatocellular carcinoma. Am Surg. 2014 Feb;80(2):191-6.
citation: Samant H, Amiri HS, Zibari GB. Addressing the worldwide hepatocellular carcinoma: epidemiology, prevention and management. J Gastrointest Oncol. 2021 Jul;12(Suppl 2):S361-S373. doi: 10.21037/jgo.2020.02.08.
Clinical trial NCT01818635: To Investigate the Effect of Montelukast on Behavior Problems in Children With Asthma
Official title: Phase 4 Study of to Investigation the Effect of Montelukast on Behavior Problems in Children With Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma, Behavior Problem, Montelukast
Lead sponsor: Fatih University
Sponsor class: OTHER
Collaborators: name: Kecioren Teaching and Research Hospital
First posted: 2013-03-26
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We planned to include who who treated for asthmatic children and healthy controls in the study.

Brief summary: The purpose of the study to investigate whether montelukast lead to behavior problems in children with asthma.


Eligibility criteria: Inclusion Criteria:

* To have asthmatic children aged 18-60 months
* To have that receive prophylactic treatment for asthma
* Healthy children will be enrolled among those being brought for routine controls

Exclusion Criteria:

* Children with other chronic disease
* Children with chronic drug use (except for the treatment of asthma)

Primary outcomes:
measure: To investigate the effect of montelukast on behavior problems in children with asthma
timeFrame: 8 months
Secondary outcomes:
measure: To compare the effects of inhaled corticosteroids and montelukast on the behavior problems.
timeFrame: 8 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Fatih University Medical School
city: Ankara
country: Turkey
facility: Fatih University
Study officials:
References:
Clinical trial NCT05240235: The Effect of Manual Lymph Drainage in the Treatment of Breast Edema
Official title: The Effect of Manual Lymph Drainage in the Treatment of Breast Edema That May Occur in Patients Undergoing Breast-conserving Surgery and Adjuvant Radiotherapy-Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer and Rehabilitation
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 36
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Breast conserving surgery (BCS) is widely used in the treatment of breast cancer. Breast edema can be seen frequently after BCS and radiotherapy applications. Breast edema affects quality of life and may result in a cosmetically unsatisfactory outcome for the patient. Therefore, it is important to treat and prevent its development. In the light of this information, the present randomized controlled study aims to determine the effect of manual lymph drainage method in the treatment of breast edema in patients undergoing breast-conserving surgery and adjuvant radiotherapy.


Eligibility criteria: Inclusion Criteria:

1. Patients who underwent breast-conserving surgery and received adjuvant radiotherapy
2. Patients with Sentinel Lymph Node Biopsy or axillary lymph node dissection
3. Female patients between the ages of 18-75
4. Patients who cannot read and write Turkish

Exclusion Criteria:

1. A previous cancer
2. Decompensated heart failure
3. Untreated congestive heart failure
4. Active infection
5. Uncontrolled hypertension
6. Acute kidney failure
7. Patients with acute deep vein thrombosis
8. Metastasis and/or recurrence during treatment
9. Patients who have undergone another surgery related to the breast and chest area
10. Patients who develop lymphedema in the upper extremity during therapy will be excluded from the study.

Primary outcomes:
measure: LENT-SOMA criteria in breast edema
timeFrame: Change from baseline LENT-SOMA criteria at 12 weeks
measure: Breast edema questionnaire
timeFrame: Change from baseline breast edema questionnaire at 12 weeks
measure: Clinical features of breast cancer and breast edema
timeFrame: Change from baseline clinical features of breast cancer and breast edema at 12 weeks
measure: Qualitiy of Life - European Organization for Research and Treatment of Cancer EORTC- BR23
timeFrame: Change from baseline Quality of life (EORTC- BR23) test at 12 weeks
Secondary outcomes:
measure: Breast pain intensity will be measured with the Visual Analog Scale
timeFrame: Change from baseline Visual Analog Scale test at 12 weeks
measure: Quality of life test (EORTC QOL-C30)
timeFrame: Change from baseline Quality of life test (EORTC QOL-C30) at 12 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Acibadem University
Study officials:
References:
Clinical trial NCT03171935: Wean Early With HFNCO vs NPPV in Patients With AHRF
Official title: Wean Early With High-Flow Nasal Cannula Oxygenation Versus Noninvasive Positive Pressure Ventilation in Patients With Acute Hypoxemic Respiratory Failure: a Multicenter, Randomized, Controlled Trial (the WHEN Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients With Acute Hypoxemic Respiratory Failure
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 270
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 main purpose of the present study is to verify whether, as compared with conventional weaning, early weaning with high-flow nasal cannula oxygenation or noninvasive positive pressure ventilation may more effective in shortening the duration of invasive ventilation, hence reducing the rates of complications and mortality in patients with acute hypoxemic respiratory failure.


Eligibility criteria: Inclusion Criteria:

1. Orotracheal intubation；
2. PaO2 \<60mmHg（venturi mask，FiO2=0.5），and PaCO2 ≤45mmHg；
3. Meeting criteria for weaning readiness；
4. Spontaneous breathing trial failure.

Exclusion Criteria:

1. Age\<18；
2. Duration of invasive ventilation \<48h；
3. Tracheotomy；
4. Percentage of cuff leak volume in tidal volume\<15.5%；
5. Unable to spontaneously clear secretions from their airway；
6. Recent oral，nasal，facial or cranial trauma or surgery；
7. Recent gastric or esophageal surgery；
8. Active upper gastro-intestinal bleeding；
9. Severe abdominal distension；
10. Lack of co-operation；
11. Chronic respiratory disease such as chronic obstructive pulmonary disease, asthma, interstitial lung disease and neuromuscular disease.

Primary outcomes:
measure: Duration of invasive mechanical ventilation
timeFrame: 2.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Institute of Respiratory Medicine, Department of respiratory and critical care medicine, Beijing Chao-Yang Hospital Jingxi Campus, Capital Medical University
Study officials:
References:
Clinical trial NCT03330535: The Effect of Active Reminders on Oral Hygiene in Orthodontics
Official title: The Effect of Active Reminders on Oral Hygiene of Patients With Fixed Orthodontic Appliances With Different Time Intervals
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Oral Hygiene
Lead sponsor: Riyadh Colleges of Dentistry and Pharmacy
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 88
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Four groups of participants will be formulated. Each will will receive messages in different time interval starting from none, once a week, three times a week and daily.
Primary purpose: PREVENTION

Brief summary: The aim of this study is to investigate the efficacy of text message active reminders at different time intervals of oral hygiene instructions in patients with orthodontic fixed appliances.

Detailed description: Participants with orthodontic fixed appliances will be recruited from the university hospital clinics to receive text message reminders of oral hygiene. Four groups of participants will be formulated. Group 1 will be the control group and will not receive text messages. Group 2 will receive messages once a week. Group 3 will receive text message reminders 3 times a week. Group 4 will receive daily reminders. At baseline, after 4 weeks and after 8 weeks, gingival index and plaque index will be measured at each time point and then compared between groups.

Eligibility criteria: Inclusion Criteria:

* Participants were having orthodontic fixed appliance treatment.
* Participants were aged 12 years old and above, owned mobile phones and did not have mental or physical disabilities.
* Participants were willing to comply with given oral hygiene instructions.

Primary outcomes:
measure: Change in Plaque Index
timeFrame: At baseline, 4 weeks and 8 weeks
measure: Change in gingival index
timeFrame: At baseline, 4 weeks and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Riyadh Elm University
state: Ar Riyad
Study officials:
affiliation: Riyadh Colleges of Dentistry and Pharmacy
name: Omar H Alkadhi, BDS,MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05814835: First in Human Study of 68Ga/64Cu-FAPI-XT117 PET/CT in Patients With Malignant Solid Tumors
Official title: First in Human Study of 68Ga/64Cu-FAPI-XT117 PET/CT in Patients With Malignant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Malignant Solid Tumors
Keywords: 68Ga-FAPI 64Cu-FAPI
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: Sinotau Pharmaceutical Group
First posted: 2023-04-18
Enrollment: 14
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 the first-in-human study of 68Ga/64Cu-FAPI-XT117, which is an prospective, single-arm phase I clinical study.

Detailed description: 20 patients with confirmed diagnosis of malignant solid tumor by histopathology or clinical judgment and required routine 18F-FDG PET/CT imaging were recruited. 68Ga/64Cu-FAPI-XT117 and 18F-FDG PET/CT were performed for each patient in any order(the interval was more than one day and less than four weeks). They were assigned to three 68Ga/64Cu-FAPI-XT117 dose groups, including 3±10% mCi、5±10% mCi and 7 ±10% mCi. PET/CT images were acquired 30min, 60min, 120min after injection. The primary end point was safety, secondary endpoints were accuracy (AC), sensitivity (SE), specificity (SP), positive predictive value (PPV), and change in management. Exploring end point was image quality, including qualitative and quantitative evaluation.

Eligibility criteria: Inclusion Criteria:

* 1. signed the informed consent
* 2. ≥18 years old
* 3. confirmed as malignant solid tumor by histopathology or clinical judgment
* 4. Patients will undergo 18F-FDG PET/CT examination

Exclusion Criteria:

* 1. Known allergy to components of the investigational drug or its analogues
* 2. suspected to have a certain disease or condition that is not suitable for the study drug
* 3. Known pregnant or lactating women

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: 7 days following injection
Secondary outcomes:
measure: The diagnostic efficacy of 68Ga/64Cu-FAPI-XT injection in PET/CT imaging of patients with malignant solid tumor
timeFrame: 2 months following injection
measure: Change in 'treatment strategy questionnaire'
timeFrame: 2 months following injection
Other outcomes:
Locations:
city: Beijing
country: China
facility: the First Medical Center, Chinese PLA General Hospital
Study officials:
affiliation: the First Medical Center, Chinese PLA General Hospital
name: Ruimin Wang
role: PRINCIPAL_INVESTIGATOR
References: