louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03791944: 3DV+TPS Applied to Radiotherapy for Nasopharyngeal Carcinoma
Official title: 3DV+TPS Applied to Radiotherapy for Nasopharyngeal Carcinoma - a Randomized, Single-blind, Multi-center Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nasopharynx Cancer
Radiotherapy
Keywords: nasopharynx cancer
Radiotherapy
Lead sponsor: Xinqiao Hospital of Chongqing
Sponsor class: OTHER
First posted: 2019-01-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Verify that 3DV+TPS is non-inferior compared to existing imported TPS and superior to existing domestic TPS.

Detailed description: The main purpose of the study was to verify that 3DV+TPS is non-inferior compared to existing imported TPS and superior to existing domestic TPS. A total of 100 patients were enrolled. The primary endpoint of the study was the objective response rate (ORR), and the secondary endpoint was the local control rate and the incidence of treatment-related side effects.

Eligibility criteria: Inclusion Criteria:

1. Consolidate other serious diseases that affect quality of life or treatment;
2. Reluctant to actively cooperate with the investigator;
3. Mergers with distant transfers;
4. Patients who have undergone head and neck surgery and radiotherapy;
5. Subjects who are affected by the disease who sign a written informed consent or follow the study procedure; or who are unwilling or unable to comply with the research requirements.
6. Those who have a history of psychotropic substance abuse who are unable to quit or have a mental disorder;
7. Participated in other clinical trials of anti-tumor drugs within 4 weeks before enrollment;
8. Pregnant or lactating women;
9. The investigator judges other conditions that may affect the clinical study and the outcome of the study.

Exclusion Criteria:

1. Those who did not follow the protocol.
2. The subject is aggravated or has a serious adverse reaction.
3. The subject himself requested to withdraw from the trial.
4. The patient is lost to follow-up or died.
5. The researcher believes that there is reason to withdraw

Primary outcomes:
measure: Objective response rate
timeFrame: 3 months follow-up after treatment
Secondary outcomes:
measure: Local control rate
timeFrame: 3 months follow-up after treatment
measure: incidence of treatment-related side effects
timeFrame: 3 months follow-up after treatment
Other outcomes:
Locations:
city: Chongqing
country: China
facility: the second affiliated hospital of Army medical university
state: Chongqing
Study officials:
References:
Clinical trial NCT05683444: Octreotide Improves Human Lymphatic Fluid Transport a Translational Trial
Official title: Octreotide Improves Human Lymphatic Fluid Transport a Translational Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Lymphatic Diseases
Chylothorax
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: University of Aarhus
name: Bispebjerg Hospital
First posted: 2023-01-13
Enrollment: 16
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-blinded cross over study
Primary purpose: TREATMENT

Brief summary: This study aims to investigate whether octreotide, a medication used off-label to treat chylothorax, has a direct effect on human lymphatic drainage. To study the effects of octreotide, the researchers conducted a pre-clinical experiment using human lymphatic vessels mounted in a myograph chamber and a clinical experiment in which a double-blinded, randomized, cross-over trial was conducted in 16 healthy adults. The results of the study will be used to determine the role of octreotide in the treatment of chylothorax and other lymphatic disorders.

Detailed description: This study aimed to investigate whether octreotide, a medication used off-label to treat chylothorax, has a direct effect on human lymphatic drainage. Chylothorax is a condition in which there is an accumulation of lymphatic fluid in the chest cavity, and the mechanism through which octreotide helps to resolve this condition is not well understood. It has been speculated that the drug may reduce lymph production, but this has not been directly demonstrated. To study the effects of octreotide on human lymphatic vessels, the investigators conducted two experiments: a pre-clinical experiment using human lymphatic vessels mounted in a myograph chamber, and a clinical experiment in which a double-blinded, randomized, cross-over trial was conducted in 16 healthy adults, assessed by using plethysmography and near-infrared fluorescence imaging. The results of the study will be used to determine the role of octreotide in the treatment of chylothorax and to clarify the mechanism through which it acts. It is important to continue researching and developing effective treatments for chylothorax, as it can be a difficult condition to manage and may cause serious complications if left untreated.

Eligibility criteria: Inclusion Criteria:

\* Healthy

Exclusion Criteria:

* No daily medication (except birth control), or allergies towards contrast agents.

Primary outcomes:
measure: Lymph rate
timeFrame: During infusion
measure: Lymph Pressure
timeFrame: During infusion
measure: Capillary filtration rate
timeFrame: During infusion
measure: Capillary filtration coefficiency
timeFrame: During infusion
measure: Isovolumetric pressure
timeFrame: During infusion
Secondary outcomes:
Other outcomes:
Locations:
city: København Ø
country: Denmark
facility: Rigshospitalet
Study officials:
References:
Clinical trial NCT02783144: Dexamethasone Added in Ultrasound-guided Transversus Abdominis Plain Block for Postoperative Analgesia
Official title: Dexamethasone Added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block Increased the Duration of Postoperative Analgesia After Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Pain
Keywords: Analgesia
Dexamethasone
Levobupivacaine
Ultrasound-guided
Tranversus Abdominis
Lead sponsor: San Salvatore Hospital of L'Aquila
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Dexamethasone Added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block Increased the Duration of Postoperative Analgesia After Laparoscopic Cholecystectomy.

Detailed description: In the ultrasound-guided TAP-Block with Dexamethasone group, dexamethasone is added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block after Laparoscopic Cholecystectomy. In the ultrasound-guided TAP-Block with saline group, saline is added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block , after Laparoscopic Cholecystectomy. In the ultrasound-guided TAP-Block with intravenously dexamethasone group, dexamethasone is intravenously injected , after Laparoscopic Cholecystectomy. After surgery the extension of postoperative analgesia, incident and rest pain were evaluate in each group.

Eligibility criteria: Inclusion Criteria:

* Patients with ASA score I and II
* age 18 years

Exclusion Criteria:

* Allergy to local anesthetics
* Allergy to general anesthetics
* Allergy or intolerance to acetaminophen
* Severe renal impairment
* Severe hepatic impairment
* Congestive heart failure
* Coagulation disorders
* hypoprotidemia
* Diabetes mellitus History
* Age greater than 70 years
* Age below 18 years
* ASA Physical than 3 Status
* Lack of informed consent
* Patients unable to discernment
* Intolerance to opiates
* Peptic Ulcer
* Abuse of alcohol and / or drugs

Primary outcomes:
measure: Extension of analgesia, assessed in minutes after TAP block
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Rest pain, assessed with Visual Analog Scale
timeFrame: 24 hours after surgery
measure: Incident pain, assessed with Visual Analog Scale
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: L'Aquila
country: Italy
facility: Emiliano Petrucci
Study officials:
affiliation: San Salvatore Academic Hospital of L'Aquila
name: Emiliano Petrucci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00254644: Morphofunctional Imaging and Developmental Dyslexia
Official title: Morphofunctional Imaging and Developmental Dyslexia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Developmental Dyslexia
Keywords: phonological treatment
language
fMRI
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2005-11-16
Enrollment: 32
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is a prospective study including 15 right-handed male subjects, aged 18 to 35 years, carrying a developmental dyslexia and 15 control subjects handed the same sex. We chose to include only male subjects to obtain a homogeneous population and to avoid the problem of a functional organization differs according to gender.

Brief summary: Developmental dyslexia is a frequent learning disability. The aim of this study is to analyze cortical thickness and phonological treatment in right handed adults with developmental dyslexia. They are compared to control adults paired with age and laterality. To study phonological treatment, the researchers used functional magnetic resonance imaging (fMRI) with a rime judgement task and silent word generation.


Eligibility criteria: Inclusion Criteria:

* Developmental dyslexia according to Critchley.
* Normal performance intelligence quotient (PIQ)
* Age: 18-35 years
* Sex: Male
* Right handed
* No hearing deficit.

Exclusion Criteria:

* No head injury
* No attention deficit hyperactivity disorder (ADHD)

Primary outcomes:
measure: Cortical thickness
timeFrame: 2 years
Secondary outcomes:
measure: Average cortical thickness
timeFrame: 2 years
Other outcomes:
Locations:
city: Tours
country: France
facility: CHU
Study officials:
affiliation: CHU Tours
name: Frédérique Bonnet-Brilhault
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02012244: Effects of Postoperative Pain Management on Immune Function After Laparoscopic Resection of Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Surgery
Keywords: analgesia; colorectal surgery; immunity; local anesthetics; opioids
Lead sponsor: Severance Hospital
Sponsor class: OTHER
First posted: 2013-12-16
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare postoperative immune function (e.g. NK cell activity) of fentanyl-based analgesic regimen versus local anesthetic wound infiltration-based anlagesic regimen after laparoscopic colorectal surgery


Eligibility criteria: Inclusion Criteria:

* ASA class I-III
* 20-80 years old
* elective laparoscopic colorectal surgery for cancer

Exclusion Criteria:

* drug allergy
* significant renal or hepatic impairment
* sign of infection

Primary outcomes:
measure: NK cell activity
timeFrame: 48 hours
measure: IL-2
timeFrame: 48 hours
Secondary outcomes:
measure: Complication and recurrence
timeFrame: 1 year
Other outcomes:
measure: Inflammatory responses
timeFrame: 48 hours
Locations:
city: Sedoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT04653844: RT-PCR Database Analysis for COVID-19 Infections and Re-infection
Official title: SARS-Cov2 (COVID-19) Infection and Reinfection Through the Analysis of a RT-PCR Results Database
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid-19
SARS-CoV Infection
Keywords: SARS-Cov2 infection
Positive SARS-Cov2 RT-PCR
SARS-Cov2 immune status
reinfection
kinetics
Rt-PCR
immunity
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Laboratoire CERBA-MPL
name: CNRS (MIVEGEC)
name: Nîmes University Hospital
First posted: 2020-12-04
Enrollment: 7000000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: French population with a positive SARS-Cov2 diagnosis documented through a positive RT-PCR result

Brief summary: The SARS-Cov2 pandemic remains associated with many concerns. One of the them is the real frequency of likely re-infection and subsequently the level of protection conferred by the acquired immunity following primary-infection. We propose to analyze a large set of laboratory data produced since the early beginning of the SARS-Cov2 spread in the French population to identify recurrent infection events and, more generally, gain insight about infection kinetics.


Eligibility criteria: Inclusion criteria:

- People with at least one positive SARS-Cov2 RT-PCR result with a known sampling date

Exclusion criteria:

- Patient refusing to participate in research

Primary outcomes:
measure: SARS-CoV-2 reinfection rate
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uh Montpellier
Study officials:
affiliation: UH MONTPELLIER
name: Vincent Foulongne, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05783544: Impact of A. Lumbricoides on Pulmonary Aspergillosis Development
Official title: Role of A. Lumbricoides in the Development of Pulmonary Aspergillosis in Chronic Obstructive Pulmonary Disease Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COPD Exacerbation Acute
Ascaris Lumbricoides Infection
Chronic Pulmonary Aspergillosis
Keywords: COPD
aspergillosis
ascariasis
cytokines
helminths
Lead sponsor: Research Institute of Epidemiology, Microbiology and Infectious Diseases, Uzbekistan
Sponsor class: OTHER_GOV
First posted: 2023-03-24
Enrollment: 200
Sex: ALL
Minimum age (years): 30
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The prevalence of ascariasis in COPD patients with and without concomitant pulmonary aspergillosis and in controls will be determined. To assess the influence of ascaridosis on the development of pulmonary aspergillosis in COPD patients cytokine status of patients will be studied.


Eligibility criteria: Inclusion Criteria:

* COPD patients
* COPD patients with aspergillosis
* COPD patients with ascariasis
* COPD patients with mix-infection
* Healthy individuals (controls)

Exclusion Criteria:

* COPD patients with other autoimmune diseases
* COPD patients with oncological diseases
* COPD patients with other co-infections

Primary outcomes:
measure: Serum interleukin-1B levels in COPD patients and controls
timeFrame: up to 12 months
measure: Serum interleukin-4 levels in COPD patients and controls
timeFrame: up to 12 months
measure: Serum interleukin-6 levels in COPD patients and controls
timeFrame: up to 12 months
measure: Serum tumor necrosis factor-a levels in COPD patients and controls
timeFrame: up to 12 months
measure: Serum interferon-gamma levels in COPD patients and controls
timeFrame: up to 12 months
measure: Correlation between cytokine status with chronic pulmonary aspergilosis insidence rate in COPD patients with and without ascariasis
timeFrame: up to 12 months
Secondary outcomes:
measure: Rate of ascariasis infestation among COPD patients and controls
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Tashkent
country: Uzbekistan
facility: Research institute of epidemiology, microbiology and infectious diseases
state: Uchtepa
Study officials:
References:
Clinical trial NCT04412044: Effect of Anti-interleukin 5 (IL5) Therapy on Sputum Cells and Cytokines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 22 asthmatics, in which mepolizumab was to be started, gave permission for inclusion and were followed up prospectively. Clinical and lung functional data, sputum analyses and cytokine measurements were analyzed.


Eligibility criteria: Inclusion Criteria:

* FEV1 \< 80% in the last 12 months
* use of high dose inhaled corticosteroids (ICS) in combination with other additional medication or continuous use of oral corticosteroids (OCS)
* at least 2 exacerbations in the last 12 months
* at least 300 blood eosinophils/µl once in the last 12 months and at the time of inclusion
* Anti-IL5 treatment prescribed by the physician

Exclusion Criteria:

* Not completing all visits

Primary outcomes:
measure: Airway inflammation
timeFrame: Day 1 and after 6 months
measure: Change in Forced Expiratory Volume in 1 seconds (FEV1)
timeFrame: Day 1 and after 6 months
Secondary outcomes:
measure: Cytokine pattern in the airways
timeFrame: Day 1 and after 6 months
measure: Cytokine pattern in the bloodstream
timeFrame: Day 1 and after 6 months
measure: Change in asthma control
timeFrame: Day 1 and after 6 months
measure: Biomarkers for airway inflammation
timeFrame: Day 1 and after 6 months
Other outcomes:
Locations:
Study officials:
affiliation: KU Leuven
name: Tatjana Decaesteker
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00821444: Ziprasidone Pharmacokinetics Using a Reduced Food Effect Formulation Compared to Pharmacokinetics From Commercial Capsules
Official title: Phase 1 Study Of Ziprasidone Pharmacokinetics Of Reduced Food Effect Formulation B16 Under Fed And Fasting Conditions Compared To Commercial Geodon Capsules Under Fed Conditions In Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: schizophrenia, pharmacokinetics, bioavailability, food effect
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-01-13
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Commercial ziprasidone capsules show a large increase in bioavailability with food. The formulation tested in this study aims to reduce or eliminate that increase.


Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Signed informed consent document

Exclusion Criteria:

* Any significant physical or psychological disease
* Concomitant administration of other pharmaceuticals

Primary outcomes:
measure: Relative bioavailability measured as geometric mean ratios of AUCinf and Cmax and the associated 90% confidence intervals calculated for various pairs of study treatments.
timeFrame: 2 months
Secondary outcomes:
measure: Adverse events reported, laboratory test results, vital signs observed with each study treatment
timeFrame: 2 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02580344: The Effect of Ibuprofen on Intrauterine Contraceptive Device Associated Uterine Bleeding
Official title: Action of Ibuprofen on IUD-associated Heavy Menstrual Bleeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Contraception
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2015-10-20
Enrollment: 128
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The Copper intrauterine device is the most common method of reversible contraception worldwide. Abnormal uterine bleeding and pain are the most common medical indications for the discontinuation of the intrauterine device.

Excessive prostaglandin release in the endometrial cavity appears to play an important role in both bleeding and pain related to copper intrauterine devices.There are many types of prostaglandin metabolites that present in the endometrium one of them is prostacyclin which causes vasodilatation and inhibits platelet aggregation. Another one is thromboxane which has two types; A2 which is active and rapidly converted into B2, which is inactive. Thromboxane causes vasoconstriction and blood clotting.

Non-steroidal anti-inflammatory drugs (NSAIDs) are prostaglandin synthetase inhibitors acting by decreasing production of endometrial prostaglandins; they can improve both heavy uterine bleeding and pain. Since its discovery; several drugs in NSAIDs class have been used to treat heavy uterine bleeding and pain associated with copper intrauterine device use such as mefenamic acid, ibuprofen and naproxen.

The most recent systematic review found NSAIDs is the most widely studied drugs for reduction of the menstrual blood and pain associated with copper intrauterine device. The Cochrane Review also found that NSAIDs are the most effective treatment to reduce the bleeding with copper intrauterine device use.


Eligibility criteria: Inclusion Criteria:

1. Women have menorrhagia secondary to IUD.
2. Planning for birth spacing for at least 1 year.
3. Patient aged between 20-45 years old.
4. No history of any medical treatment.
5. Living in a nearby area to make follow-up reasonably possible.

Exclusion Criteria:

1. Evidence of defective coagulation.
2. History or evidence of malignancy.
3. Hyperplasia in the endometrial biopsy.
4. Incidental adnexal abnormality on ultrasound.
5. Untreated abnormal cervical cytology
6. contraindications to ibuprofen

Primary outcomes:
measure: Number of bleeding days per month
timeFrame: 3 months
Secondary outcomes:
measure: Uterine Doppler indices
timeFrame: 3 months
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
References: