louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04905056: A Prospective, Two-center, Single Arm Phase II Clinical Study to Evaluate Safety and Effectiveness of Ablation Therapy in the Treatment of Lung Cancer Presenting as Ground-glass Nodules
Official title: A Prospective, Two-center, Single Arm Phase II Clinical Study to Evaluate Safety and Effectiveness of Ablation Therapy in the Treatment of Lung Cancer Presenting as Ground-glass Nodules
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Progression
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective, two-center, single arm phase II clinical study to evaluate safety and effectiveness of ablation therapy in the treatment of lung cancer presenting as ground-glass nodules


Eligibility criteria: Inclusion Criteria:

1. Aged between 18 and 85 years;
2. GGO is diagnosed by lung CT and failure to subside after 3 months (the patient having been re-examined by thin-section CT);
3. The maximum diameter of the GGO is bigger than 8mm and smaller than 3cm;
4. For single GGO: obvious progress was observed in pure GGO or the solid component of mixed ground glass nodules was more than or equal to 2 mm
5. The patients were unable to tolerate the operation for various reasons or multiple grinding glass nodules, operation can not be completely removed; or patients had received surgery in ipsilateral chest
6. The patient is able to understand and comply with the study and has provided written informed consent

Exclusion Criteria:

1. Patients who participated in any drug and / or medical device clinical trials within one month before the trial
2. had severe disease conditions
3. allergy to narcotic drugs
4. had other autoimmune disease
5. dementia or cognitive impairment can't cooperate with researchers
6. any local treatment other than ablation was received within 4 weeks before the study

Primary outcomes:
measure: progression free survival
timeFrame: 1 years
Secondary outcomes:
measure: overall survival
timeFrame: 1 years, 3 years, 5years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Thoracic Surgery, Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT02263456: A Study to Compare the Pharmacokinetics and Safety of Replenine®-VF, Replenine® or Other Factor IX in Haemophilia B
Official title: An Open Study to Compare the Pharmacokinetics and Safety of Replenine®-VF and Replenine® or Any Other High Purity Factor IX Concentrate, in Severe Haemophilia B Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Haemophilia B
Lead sponsor: Bio Products Laboratory
Sponsor class: OTHER
First posted: 2014-10-13
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is:

* to compare the pharmacokinetics of Replenine®-VF and Replenine® or any other high purity Factor IX concentrate, when given as a bolus dose of 75IU/kg.
* to compare the 1st and 2nd pharmacokinetic assessments on Replenine®-VF (conducted 3 months apart) and recovery if patients changes batches.
* to evaluate Replenine®-VF in terms of clinical tolerance and safety in patients with severe haemophilia B.


Eligibility criteria: Inclusion Criteria:

* Patients aged 12 years or over
* At least 20 exposures suffering from severe Haemophilia B and without inhibitors to Factor IX and on Replenine® or any other high purity Factor IX product

Exclusion Criteria:

-

Primary outcomes:
measure: Area under the concentration/time curve (AUC) for plasma Factor IX
timeFrame: Pre-dose, 10, 30 min, 1, 3, 6, 9, 12, 24, 30, 36, 50, 56 hr post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Hampstead
country: United Kingdom
facility: The Royal Free Hospital, Pond Street
state: London
city: Basingstoke
country: United Kingdom
facility: The North Hampshire Hospital, Aldermaston Road
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital, Hills Road
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales, Health Park
city: Hull
country: United Kingdom
facility: Kingston General Hospital, Beverly Road
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary, Infirmary Square
city: Lincoln
country: United Kingdom
facility: Lincoln County Hospital, Greetwell Road
Study officials:
References:
Clinical trial NCT00845988: Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders
Official title: Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders Having Drug-induced Weight Gain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorders
Metabolic Complication
Keywords: Bipolar disorder
metabolic complication
Aripiprazole
Weight gain
Clinical Trial
Antipsychotic
Metabolic syndrome
Psychopharmacology
Open Label
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Korea Otsuka Pharmaceutical Co., Ltd.
First posted: 2009-02-18
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary goal of this study is to investigate metabolic changes and maintaining efficacy in stabilized patients with bipolar disorders who have pharmacologically induced weight gain.

Detailed description: * reduced treatment adherence due to metabolic side effects
* suggested advantages of aripiprazole in metabolic profile over other antipsychotics or mood stabilizers
* randomized trial of switch from previous drugs to aripiprazole

Eligibility criteria: Inclusion Criteria:

* patients with bipolar disorders (I, II, NOS) diagnosed with DSM-IV criteria
* age between 18 and 65
* Decisional capacity is adequate to provide informed consent or has an authorized appropriate surrogate decision maker. in a syndromal remission state at least for 2 months : CGI - BP ≤ 3
* patients who have exhibited a clinically significant increase in body weight after starting the administration of their current antipsychotic (ie \>7% weight gain)

Exclusion Criteria:

* diagnosis of eating disorder, substance abuse, and psychotic disorder
* history of neurological and medical illness
* pregnant or breast feeding women

Primary outcomes:
measure: Weight BMI Glucose and lipid profiles CGI-BP KOQOL SWN-K
timeFrame: 0, 4, 8, 12, 18, 26 week
Secondary outcomes:
measure: ECG prolactin SAS BAS UKU-SERS-Pat-Korean version
timeFrame: 0, 4, 8, 12, 18, 26 week
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Kyooseob Ha, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04231188: User Experience of a Mobile Application
Official title: Evaluating the User Experience of a Mobile Application in Recording Primary Caregiver Reported Outcomes of Infants
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: User Experience of Mobile Application
Lead sponsor: Danone Asia Pacific Holdings Pte, Ltd.
Sponsor class: INDUSTRY
First posted: 2020-01-18
Enrollment: 6
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infants from birth to ≤ 12 months of age and their primary caregiver

Brief summary: To evaluate the user experience of the use of the different modules / trackers in the mobile application in recording primary caregiver reported outcomes of infants

Detailed description: Using a questionnaire to collect overall user experience, frequency of usage, feedback of each module in the mobile application

Eligibility criteria: Inclusion Criteria:

1. Infants from birth to ≤ 12 months of age.
2. Primary caregiver should have access to the internet and a smartphone or tablet to access the mobile application.
3. Primary caregiver should be able to comprehend the content in the mobile application and complete the questionnaires in English.
4. Primary caregiver takes care of the infant more than 50% of the time

Exclusion Criteria:

* Incapability of the primary caregiver to access the mobile application using a smartphone or tablet with internet

Primary outcomes:
measure: Overall User experience
timeFrame: Day 14
Secondary outcomes:
measure: User experience (ease of use) - Primary Caregiver
timeFrame: Day 14
measure: User experience (frequency of use) - Primary Caregiver
timeFrame: Day 14
measure: User experience (usefulness) - Healthcare Professionals (HCP)
timeFrame: Day 14
measure: User experience (relevance) - Healthcare Professionals (HCP)
timeFrame: Day 14
Other outcomes:
measure: User experience (ease of use) - Primary Caregiver from Day 0 to Day 45
timeFrame: Day 0 to Day 45
measure: User experience (frequency of use) - Primary Caregiver from Day 0 to Day 45
timeFrame: Day 0 to Day 45
measure: User experience (quality of insights) - Primary Caregiver from Day 0 to Day 45
timeFrame: Day 0 to Day 45
measure: User experience (weighing scale) - Primary Caregiver from Day 0 to Day 45
timeFrame: Day 0 to Day 45
measure: User feedback (weighing scale) - Primary Caregiver from Day 0 to Day 45
timeFrame: Day 0 to Day 45
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Poh Choo Khoo, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06248788: Salivary Immunoglobulin A (sIgA) Normal Range Study
Official title: Study to Survey the Normal Range of Salivary Immunoglobulin A (sIgA) Levels Measured by a Point of Care Device in Healthy Adult Women and Men
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Salivary Immunity
Keywords: salivary immunoglobulin A
point of care device
Lead sponsor: 4Life Research, LLC
Sponsor class: INDUSTRY
First posted: 2024-02-08
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: any adults that are free from oral infections or oral diseases

Brief summary: Salivary Immunoglobulin A (sIgA) is a marker of immune system activity. Typically, sIgA is determined by an ELISA test in which samples have to be sent to a specialized laboratory for testing. Investigators have developed a new instrument that is small, portable, and easy to use. This instrument is available for consumers to purchase and test their own sIgA at home.


Eligibility criteria: Inclusion Criteria:

* Adults committed to attend the session and follow the instructions described in Experimental Design will be included.

Exclusion Criteria:

* Participant with mouth infection or oral disease

Primary outcomes:
measure: Salivary IgA
timeFrame: 0 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Sandy
country: United States
facility: 4Life Research
state: Utah
Study officials:
References:
Clinical trial NCT04305288: Chemotherapy mFOLFIRINOX in Locally Advanced or Metastatic Cholangiocarcinoma
Official title: Modified FOLFIRINOX Versus Gemcitabine Plus Oxaliplatin as First-line Chemotherapy for Patients With Locally Advanced or Metastatic Cholangiocarcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cholangiocarcinoma of the Bile Duct
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2020-03-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with locally advanced or metastatic CCA.

Brief summary: The aim of this study was to evaluate the effectiveness of modified FOLFIRINOX (mFOLFIRINOX) compared to that of gemcitabine plus oxaliplatin (Gemox) for patients with locally advanced or metastatic CCA

Detailed description: The aim of this study was to evaluate the effectiveness of modified FOLFIRINOX (mFOLFIRINOX) compared to that of gemcitabine plus oxaliplatin (Gemox) for patients with locally advanced or metastatic CCA

Eligibility criteria: The inclusion criteria included: patients aged 18-70 years old, regardless of gender; patients with locally advanced or metastatic CCA diagnosed by imaging and pathology; modified FOLFIRINOX regimen or Gemox regimen as first-line treatment; ≥ 1 focus that can be evaluated by imaging examination.

Exclusion criteria included: incomplete clinical history data; suffering from other malignant tumors within 5 years, except basal cell carcinoma and cervical carcinoma in situ; having received other systemic chemotherapy, targeted therapy, immunotherapy or radiotherapy as first-line treatment; with severe organ dysfunction.

Primary outcomes:
measure: Progression Free Survival
timeFrame: up to 1 year
Secondary outcomes:
measure: Overall survival
timeFrame: up to 2 years
measure: Objective Response Rate
timeFrame: up to 1 year
measure: Disease Control Rate
timeFrame: up to 1 year
measure: percentage of patients with Clinical Benefit Response
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xinhua Hospital
state: Shanghai
Study officials:
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: yingbin liu, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zou L, Li X, Wu X, Cui J, Cui X, Song X, Ren T, Han X, Zhu Y, Li H, Wu W, Wang X, Gong W, Wang L, Li M, Lau WY, Liu Y. Modified FOLFIRINOX versus gemcitabine plus oxaliplatin as first-line chemotherapy for patients with locally advanced or metastatic cholangiocarcinoma: a retrospective comparative study. BMC Cancer. 2021 Jul 16;21(1):818. doi: 10.1186/s12885-021-08549-2.
Clinical trial NCT06893588: Registry on NeVa VS for CerebraL VAsospasm ManagemenT in Post SAH PatiEnts
Official title: Prospective, Open-Label, Multi-Center ProceDural Data CollectIon Case Registry on NeVa VS for CerebraL VAsospasm ManagemenT in Post SAH PatiEnts (The DILATE Registry)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cerebral Vasospasm
Aneurysmal Subarachnoid Hemorrhage (aSAH)
Keywords: vasospasm
Lead sponsor: Vesalio
Sponsor class: INDUSTRY
First posted: 2025-03-25
Enrollment: 200
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subjects with cerebral vasospasm

Brief summary: A multi-center, observational registry study intended to assess the HDE-approved NeVa VS cerebral artery dilation device in patients with symptomatic cerebral vasospasm caused by aneurysmal subarachnoid hemorrhage (aSAH)


Eligibility criteria: Inclusion Criteria:

1. Age ≥22
2. Symptomatic cerebral vasospasm secondary to aneurysmal subarachnoid hemorrhage (aSAH) in the internal carotid artery (ICA), middle cerebral artery (MCA), anterior cerebral artery (ACA), posterior cerebral artery (PCA), or basilar artery (BA)
3. Vessel dilation procedure was performed with the NeVa VS
4. Subject or legal representative is able and willing to give informed consent within 3 days (72 hours) post-index procedure

Exclusion Criteria:

* None

Primary outcomes:
measure: Improvement in target vessel diameter following NeVa VS use
timeFrame: Up to 1 hour post procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00934388: A Randomised, Blinded Study on Laparoscopic Mesh Reinforcement for Chronic Groin Pain
Official title: A Randomised, Blinded Study on Laparoscopic Mesh Reinforcement for Chronic Groin Pain.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Groin Pain
Keywords: Sportsmans groin, Gilmores groin
Lead sponsor: Royal Hobart Hospital
Sponsor class: OTHER_GOV
First posted: 2009-07-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic groin pain is a frequent cause for referral to general surgeons. In some cases this pain may be due to the presence of a hernia. However, if on clinical examination there is no palpable lump or bulge, the cause of the pain may be difficult to elucidate. Some of these patients may have the diagnosis of sportsman's groin. Other names which have been attached to this condition include Gilmores groin and sportsmans hernia. These conditions are more commonly associated with sportsmen and women but those who do not play sport may also receive this diagnosis. Sportsman's groin is thought to be a syndrome of weakness of the posterior inguinal wall without a clinically recognisable hernia. Differing explanations for sportsman's groin include avulsion of the conjoint tendon from the pubic tubercle, weakening of the transversalis fascia, tears in the internal or external oblique, superficial inguinal ring dilatation and abnormalities of the rectus abdominus insertion.

There is some evidence that pre peritoneal mesh placement in these patients may be beneficial. The theory being that the mesh prevents pressure transmission to the damages structures, allowing them to heal more rapidly.

Aim. To assess the potential benefit of pre peritoneal mesh placement using the TAPP technique in patients with chronic groin pain.


Eligibility criteria: Inclusion Criteria:

* Groin pain (unilateral or bilateral) for at least 4 months. In this way, patients with temporary symptoms will be excluded from undergoing unnecessary surgery.
* Tenderness over pubic tubercle or superficial inguinal ring.

Exclusion Criteria:

* Aged less than 18 years Aged more than 50 years - due to increased incidence of sacro-iliac and hip pathology.
* Bulge, lump or cough impulse consistent with inguinal or femoral hernia on clinical examination.
* Patients unwilling or unable to provide informed consent. Medically unfit for general anaesthetic
* Pregnant women
* Diabetes - due to diabetic neuropathy
* Steroid use
* QST suggestive of nerve entrapment.

Primary outcomes:
measure: Return to normal activities
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hobart
country: Australia
facility: Royal Hobart Hospital
state: Tasmania
Study officials:
References:
Clinical trial NCT06087588: Pericapsular Nerve Group Block Chemical Neurolysis in Advanced Hip Osteoarthritis
Official title: The Impact of the Pericapsular Nerve Group Block (PENG) Chemical Neurolysis on the Quality of Life of Patients with Advanced Hip Osteoarthritis. a Randomized, Prospective Double-blinded Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Osteoarthritis, Hip
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Group 1 - PENG sham block Group 2 - PENG neurolysis 95% ethanol
Primary purpose: TREATMENT

Brief summary: PENG neurolysis in advanced osteoarthritis of the hip joint.

Detailed description: The study aims to assess the safety and effectiveness of regional pain treatment methods and their impact on the quality of life of patients with advanced osteoarthritis of the hip joint.

Eligibility criteria: Inclusion Criteria:

* Patients of the Pain Treatment Clinic of the Transfiguration of Jesus Clinical Hospital of the Medical University of Poznań will be qualified for the study
* patients with coxarthrosis or gonarthrosis who failed to achieve satisfactory pain control (NRS\>3) despite the use of NSAIDs, Paracetamol, and co-analgetics
* Age of patients: from 18 to 110 years of age.
* Caucasian patients can give informed, complete, written consent.

Exclusion Criteria:

* suspected or diagnosed opioid dependence syndrome
* active cancer
* dementia

Primary outcomes:
measure: NRS score
timeFrame: 7 days after procedure
measure: NRS score
timeFrame: 30 days after procedure
measure: NRS score
timeFrame: 3 months after procedure
measure: NRS score
timeFrame: 6 months after procedure
Secondary outcomes:
measure: Health Questionnaire (EQ-5D-5L)
timeFrame: 7 days after procedure
measure: Health Questionnaire (EQ-5D-5L)
timeFrame: 30 days after procedure
measure: Health Questionnaire (EQ-5D-5L)
timeFrame: 3 months after procedure
measure: Health Questionnaire (EQ-5D-5L)
timeFrame: 6 months after procedure
measure: neurological deficits
timeFrame: 7 days after procedure
measure: neurological deficits
timeFrame: 30 days after procedure
measure: neurological deficits
timeFrame: 3 months after procedure
measure: neurological deficits
timeFrame: 6 months after procedure
measure: total opioid consumption
timeFrame: 7 days after procedure
measure: total opioid consumption
timeFrame: 30 days after procedure
measure: total opioid consumption
timeFrame: 3 months after procedure
measure: total opioid consumption
timeFrame: 6 months after procedure
Other outcomes:
Locations:
city: Poznan
country: Poland
facility: Poznan University of Medical Sciences
state: Poznań
Study officials:
affiliation: Poznań University of Medical Sciences
name: Katarzyna Wieczorowska-Tobis, Prof.dr hab
role: STUDY_DIRECTOR
References: