louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03157310: Bone Metastasis on the Survival of Gefitinib Effective Patients
Official title: Bone Metastasis on the Survival of Gefitinib Effective Patients With Non-small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overal Survival, Non-small Cell Lung Cancer
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 265
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: Gefitinib is a selective small molecule epidermal growth factor receptors (EGFR) tyrosine kinase inhibitors (EGFR-TKI), it's curative effect on non-small cell lung cancer (NSCLC) has been confirmed by a number of prospective clinical trials. The researches aim to analysis whether bone metastasis could affect the survival of NSCLC patients who were effective in Gefitinib treatment over 6 months.

Detailed description: The epidermal growth factor receptors (EGFRs) have inhibitory effects on cell apoptosis, cell growth, angiogenesis and metastasis of tumor cell. The advent of EGFR-TKI significantly improved the clinical efficacy and safety of non-small cell lung cancer (NSCLC) treatment. Compelling study also demonstrate Gefitinib may be effective in the treatment of bone metastases. For NSCLC patients who were effective in EGFR-TKI treatment, whether bone metastasis would shorten the survival time of the patients or reduce the quality of life of patients is worth studying. The researches aim to analysis whether bone metastasis could affect the survival of NSCLC patients who were effective in Gefitinib treatment over 6 months.

Eligibility criteria: Inclusion Criteria:

1. histological and (or) cytological diagnosed NSCLC patients.
2. patient was effective in Gefitinib treatment more than 6 months.
3. whether patient received chemotherapy and other treatment is not restricted.
4. whether patient was detected for EGFR gene mutation was not restricted.

Exclusion Criteria:

1. patient with small cell lung cancer.
2. patient without cytology or histopathology diagnosis results.
3. patient with bone metastases cannot rule out other reasons such as inflammation or trauma.
4. patient with poor treatment compliance.
5. patient with incomplete data.

Primary outcomes:
measure: Overal survival of patients
timeFrame: 5 years
Secondary outcomes:
measure: Survival of patients with both bone metastasis and brain metastasis
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Hai-Chun Liu, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03650010: Total Ankle Replacement: Clinical and Radiological Outcomes
Official title: Evaluation of Epidemiology and Radiological and Clinical Outcomes in Total Ankle Prosthesis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ankle Arthritis
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2018-08-28
Enrollment: 1066
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: 1066 patients who underwent total ankle replacement

Brief summary: This retrospective and prospective study intends to evaluate the epidemiology and effectiveness of ankle joint surgery in patients operated from January 2011 to March 2026, evaluating the results both clinically and radiographically.

Detailed description: The aim of this study is to evaluate radiographically and clinically using clinical and radiographic outcomes . Few studies exist in the literature and rarely report fix-bearing and mobile-bearing prosthetics \[1-4\]. Therefore the data related to this study can be considered a reference in the literature.

Patients who performed and will perform ankle prosthesis surgery from January 2011 to March 2026 and who underwent a clinical evaluation (also using questionnaires and scores) and radiographic evaluation.

The clinical data and radiological parameters were collected together with the visits and the procedures prescribed according to the clinical routine of the department.

Eligibility criteria: Inclusion Criteria:

* Males and females
* age ≥ 18 years at the time of surgery
* patients who underwent ankle replacement surgery from January 2011 to March 2026

Exclusion Criteria:

- age \< 18 years at the time of surgery

Primary outcomes:
measure: Changes in American orthopaedic foot and ankle society (AOFAS) ankle-hindfoot score
timeFrame: Pre operatively, 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively
measure: Changes in Short form 12 (SF 12)
timeFrame: Pre operatively, 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively
measure: Anterior distal tibial angle
timeFrame: Pre operatively
measure: Changes in beta angle
timeFrame: 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively
measure: Changes in alpha angle
timeFrame: 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively
measure: Medial distal tibial angle
timeFrame: Pre operatively
Secondary outcomes:
measure: Changes in visual analogue scale
timeFrame: Pre operatively, 2 months post-operatively, 6 months post-operatively, 12 months post-operatively, 24-36-48-60-72-84-96-108-120 months post-operatively
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Irccs Istituto Ortopedico Galeazzi
state: Milano
Study officials:
References:
Clinical trial NCT04960410: Real Time Early Warning Model and Mobile Medical Assistant System for the Impact of Air Pollution on AECOPD Disease
Official title: Real Time Early Warning Model and Mobile Medical Assistant System for the Impact of Air Pollution on Acute Exacerbation of Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Beihang University
First posted: 2021-07-13
Enrollment: 56
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stable chronic obstructive pulmonary disease (COPD) patients

Brief summary: Objective to establish a real-time early warning model of acute exacerbation of chronic obstructive pulmonary disease (COPD) caused by air pollution, and develop the corresponding mobile medical assistant system. Through the cross fusion of existing information technology and medical research results, an auxiliary medical system is formed for information recording, tracking tools, early warning model and clinical diagnosis of patients with COPD.

Detailed description: Objective to establish a real-time early warning model of acute exacerbation of chronic obstructive pulmonary disease (COPD) caused by air pollution, and develop the corresponding mobile medical assistant system. Through the cross fusion of existing information technology and medical research results, an auxiliary medical system is formed for information recording, tracking tools, early warning model and clinical diagnosis of patients with COPD.

Eligibility criteria: Inclusion Criteria:

* Patients aged \> 40 and \< 80 years with post-bronchodilator FEV1/ forced vital capacity (FVC) \< 0.7 and percentage predicted of FEV1\>30%, who were no exacerbation of symptoms in the 6 weeks preceding the study, were included in the study.

Exclusion Criteria:

* Patients who were diagnosed with other chronic respiratory diseases, including bronchial asthma, bronchiectasis and lung abscess.
* Patients with near-terminal illness, congestive heart failure (NYHA III-IV), or cannot record CAT score timely were excluded.

Primary outcomes:
measure: Frequency of acute exacerbations
timeFrame: 1 year incidence rate
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Yahong Chen, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT06887010: A Study to Assess How Food Affects the Movement of Oral ABBV-101 Through the Body of Healthy Adult Participants
Official title: A Study to Assess the Effect of Food on ABBV-101 Pharmacokinetics When Administered as an Oral ABBV-101 Tablet Formulation in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Healthy Volunteer
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2025-03-20
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will assess the effect of food (high fat) on oral ABBV-101 and how ABBV-101 moves through the body in healthy adult participants


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at the time of screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG

Exclusion Criteria:

* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
* Consumption of alcohol, grapefruit products, Seville oranges, starfruit products or quinine/tonic water within the 72-hour period prior to study treatment administration.
* Use of tobacco- or nicotine-containing products within 90 days prior to the first dose of study treatment.

Primary outcomes:
measure: Number of Participants Experiencing Adverse Events
timeFrame: Up to approximately 45 days
measure: Maximum Observed Plasma Concentration (Cmax) of ABBV-101
timeFrame: Up to approximately 21 days
measure: Time to Cmax (Tmax) of ABBV-101
timeFrame: Up to approximately 21 days
measure: Area Under the Plasma Concentration-Time Curve (AUC) of ABBV-101
timeFrame: Up to approximately 21 days
measure: Terminal Phase Elimination Half-life (t1/2) of ABBV-101
timeFrame: Up to approximately 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Grayslake
country: United States
facility: Acpru /Id# 275921
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02573610: Study of DE-108 Ophthalmic Solution in Patients Who Are Scheduled for Cataract Surgery
Official title: A Randomized, Double-masked, Parallel Group Study of DE-108 Ophthalmic Solution in Patients Who Are Scheduled for Cataract Surgery (Levofloxacin 0.5% Ophthalmic Solution as a Comparator) - Phase III, Confirmatory Study of Perioperative Bacteria Eradication -
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract Surgery
Lead sponsor: Santen Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-10-12
Enrollment: 576
Sex: ALL
Minimum age (years): 19
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 evaluate superior efficacy of DE-108 ophthalmic solution to that of Levofloxacin 0.5% ophthalmic solution as well as safety of the former used for perioperative bacteria eradication in patients who are scheduled for cataract surgery.


Eligibility criteria: Inclusion Criteria:

* Those who are scheduled for cataract surgery

Exclusion Criteria:

* Those who with suspected ocular infections based on clinical findings in the study eye.
* Those who have any eye disease other than cataract which requires treatment in the target eye.
* Those who have a history of allergy to the drugs to be used during the clinical study (such as fluoroquinolones, topical anesthetics and povidon iodine)
* Those who need to wear contact lenses during the study period

Primary outcomes:
measure: Change in the percentage of positive bacteriological test results (from Day -3 to Day 0)
timeFrame: 3 days (Day -3 to Day0)
Secondary outcomes:
Other outcomes:
Locations:
city: Kyungpook
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Kim's eye Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Saint Marry's Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
Study officials:
References:
Clinical trial NCT03678610: Handling Medium for ICSI With Ionomycin and Latrunculin A
Official title: Latrunculin A and Ionomycin as a Handling Medium for ICSI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Ibn Sina Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Banoon IVF Center
name: Qena Fertility Center
First posted: 2018-09-19
Enrollment: 700
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Using Latrunculin A and Ionomycin would improve the outcome of ICSI if the handling medium during the ICSI procedure has them.


Eligibility criteria: Inclusion Criteria:

* indication for ICSI

Exclusion Criteria:

-

Primary outcomes:
measure: Fertilization rate
timeFrame: 6 days of culture
Secondary outcomes:
measure: Rates of Blastocyst formation and quality
timeFrame: 6 days of culture
measure: embryo utilization rate
timeFrame: 6 days of culture
measure: clinical pregnancy rate
timeFrame: three months
measure: ongoing pregnancy rate
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Banon Assiut
city: Qena
country: Egypt
facility: Qena Fertility Center
city: Sohag
country: Egypt
facility: IbnSina IVF Center
Study officials:
References:
Clinical trial NCT04365010: Low-chlorine Vs High-chlorine Crystalloids in Septic Shock Adults
Official title: Effects of Low-chlorine Vs High-chlorine Crystalloid Solutions in Septic Shock Adults
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Septic Shock
Keywords: crystalloids, septic shock, MAKE30
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective cluster-randomized, multiple-crossover trial
Primary purpose: TREATMENT

Brief summary: Fluid resuscitation is an important treatment in septic shock patients, however whether crystalloid composition affects septic shock patients outcomes remains unclear. According to previous studies, low-chlorine crystalloids could significantly reduce the incidence of kidney injury and 30-day mortality compared with high-chlorine crystalloids in critically ill adults. Therefore, we hypothesized that the use of low-chlorine crystalloids would result in a lower incidence of major adverse kidney events within 30 days (MAKE 30: overall incidence of death, new renal-replacement therapy, and persistent renal dysfunction) than high-chlorine crystalloids in septic shock adults.


Eligibility criteria: Inclusion Criteria:

1. 18 years old \<age ≤ 85 years old;
2. Diagnosis of septic shock within 24 hours (sepsis 3.0);
3. Needing fluid resuscitation judged by clinicians;
4. The patient or the patient's legally acceptable representative signs the informed consent (signs within 24h of enrollment)

Exclusion Criteria:

1. Pregnant or lactating period;
2. Renal replacement therapy has been received or expected to receive within 6 hours;
3. Those who were previously enrolled in the study;
4. Estimated death within 24 hours;
5. Other situations that not suitable for enrollment judged by researchers.

Primary outcomes:
measure: the composite of death and new receipt of renal-replacement therapy MAKE30
timeFrame: up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05951010: Cerebellar Transcranial Direct Current Stimulation in Spinocerebellar Ataxia 38
Official title: Comparison of Two Therapeutic Approaches of Cerebellar Transcranial Direct Current Stimulation in a Sardinian Family Affected by Spinocerebellar Ataxia 38: a Clinical and Computerized 3D Gait Analysis Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinocerebellar Ataxias
Keywords: gait
ataxic symptoms
dysarthric symptoms
Lead sponsor: University of Cagliari
Sponsor class: OTHER
Collaborators: name: Angela Sanna
name: Micaela Porta
name: Paolo Tacconi
name: Chiara Pau
First posted: 2023-07-18
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Spinocerebellar ataxia 38 (SCA 38) is a very rare autosomal dominant inherited disorder caused by a mutation in ELOV5 gene, specifically expressed in cerebellar Purkinje cells, encoding an enzyme involved in the synthesis of fatty acids. The present study aimed to assess the effect of cerebellar anodal transcranial direct current stimulation (tDCS) administered employing deltoid (CD-tDCS) and spinal (CS-tDCS) cathodal montage. Clinical evaluation was performed at baseline (T0), after 15 sessions of tDCS (T1) and after one month of follow-up (T2).


Eligibility criteria: Inclusion Criteria:

1. age ≤ 80 and \> 18 years
2. diagnosis of SCA 38 with the presence of clinical symptoms.

Exclusion Criteria:

1. Inability to understand and sign the informed consent
2. Presence of other severe neurological disorders
3. presence of significant medical or psychiatric illnesses
4. Pregnancy.

Primary outcomes:
measure: Modified International Cooperative Ataxia Rating Scale (MICARS)
timeFrame: Baseline, change after 3 weeks, change after 3 months
measure: Robertson dysarthria profile
timeFrame: Baseline, change after 3 weeks, change after 3 months
Secondary outcomes:
measure: Gait Speed
timeFrame: Baseline, change after 3 weeks, change after 3 months
measure: Step width
timeFrame: Baseline, change after 3 weeks, change after 3 months
measure: Double support phase duration
timeFrame: Baseline, change after 3 weeks, change after 3 months
Other outcomes:
Locations:
city: Monserrato
country: Italy
facility: Laboratorio di Biomeccanica ed Ergonomia industriale - Università degli Studi di Cagliari
state: Cagliari
Study officials:
References:
Clinical trial NCT03001310: Gene Therapy for Achromatopsia (CNGB3)
Official title: An Open Label, Multi-centre, Phase I/II Dose Escalation Trial of a Recombinant Adeno-associated Virus Vector (AAV2/8-hCARp.hCNGB3) for Gene Therapy of Adults and Children With Achromatopsia Owing to Defects in CNGB3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Achromatopsia
Lead sponsor: MeiraGTx UK II Ltd
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2016-12-23
Enrollment: 23
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: A clinical trial of AAV - CNGB3 retinal gene therapy for patients with achromatopsia

Detailed description: CNGB3 retinal gene therapy for patients with achromatopsia

Eligibility criteria: Inclusion Criteria:

* Are aged 3 years or older
* Have achromatopsia confirmed by a retinal specialist (CI or PI)

Exclusion Criteria:

* Are females who are pregnant or breastfeeding
* Have participated in another research study involving an investigational medicinal therapy for ocular disease within the last 6 months
* Have any other condition that the CI/PI considers makes them inappropriate for entry into the trial

Primary outcomes:
measure: Number of Participants Meeting the Primary Outcome Defined as Any of the Below Events Occurring During the 6 Weeks Following Administration, at Least Possibly Related to the Advanced Therapy Investigational Medicinal Products (ATIMP), Not Surgery Alone.
timeFrame: 6 weeks
Secondary outcomes:
measure: Improvements in Visual Function as Assessed by Visual Acuity
timeFrame: 6 months
measure: Improvements in Retinal Function as Assessed by Static Perimetry
timeFrame: 6 months
measure: Quality of Life Measured by QoL Questionnaires in Children and Adolescents
timeFrame: 6 months
measure: Quality of Life Measured by QoL Questionnaires in Adults
timeFrame: 6 Months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Kellog Eye Centre
state: Michigan
city: London
country: United Kingdom
facility: Moorfields Eye Hospital NHS Foundation Trust
Study officials:
affiliation: Chief Investigator
name: James Bainbridge, Prof
role: PRINCIPAL_INVESTIGATOR
References: