louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00328562: ZD1839 With Hypofractionated Radiation Therapy With an Immobilization Device for Advanced Non-Small Cell Lung Cancer
Official title: A Phase I Study of ZD1839 (Iressa) and Hypofractionated Thoracic Radiotherapy With Stereotactic Body Frame Immobilization for Patients With Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Small Cell Lung Carcinoma (NSCLC)
Keywords: Advanced NSCLC
Non-Small Cell Lung Carcinoma
Stage IV NSCLC
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2006-05-22
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and effectiveness of Iressa when used with a short course of high dose radiation therapy in patients with lung cancer.

Detailed description: To estimate treatment-related esophageal, pulmonary, hematologic, and other toxicity of patients with non-small-cell lung cancer (NSCLC) receiving ZD1839 with hypofractionated thoracic radiotherapy (RT). All estimates of toxicity rates will be presented with corresponding confidence intervals using the exact method. The method of Atkinson and Brown will be used due to the two-stage sampling; the method of Conover will be used for tumor response.

To estimate tumor response rates of this treatment regimen and identify the most effective RT dose level, defined as the level associated with the best response rate. Estimates of tumor response rates will be presented with corresponding confidence intervals using the exact method of Conover. Survival will be estimated by the Kaplan-Meier method.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed non small cell lung cancer
* Stage IV needing radiation therapy to control symptoms
* Patients with brain metastases
* Unresectable or medically inoperable

Exclusion Criteria:

* Small cell lung cancer
* Previous thoracic radiation therapy
* Oxygen-dependent patients
* Forced expiratory volume in 1 second (FEV1) less than 1.5
* Patients with active interstitial lung disease
* Patients with underlying lung disease

Primary outcomes:
measure: Patients Affected by Treatment-related Morbidities
timeFrame: Twice weekly during RT and at 1-, 2-, 3-, 4-, 5-, and 6-month points after therapy
Secondary outcomes:
measure: Tumor Response
timeFrame: Baseline, 1, 3, and 5 months post-treatment
measure: Progression-free Survival
timeFrame: Baseline to date of progression
measure: Survival From Starting Gefitinib
timeFrame: Baseline to date of expiration
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Maria Werner-Wasik, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01339962: Retrospective Analysis Of Progression Free Survival And Overall Survival In A National Cohort Of Patients With Metastatic Renal Cell Carcinoma Treated In Denmark From 2006-2010. DARENCA Study 2.
Official title: Retrospective Analysis Of Progression Free Survival And Overall Survival In A National Cohort Of Patients With Metastatic Renal Cell Carcinoma Treated In Denmark From 2006-2010. DARENCA Study 2.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Keywords: Metastatic renal cell carcinoma
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Copenhagen University Hospital at Herlev
name: Rigshospitalet, Denmark
name: Aarhus University Hospital
name: Odense University Hospital
name: Danish Renal Cancer Study Group
First posted: 2011-04-21
Enrollment: 1073
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: All Danish patients diagnosed with metastatic renal cell carcinoma referred to the involved centers.

Brief summary: Non-interventional study. Data obtained by patient chart reviews.

Retrospective analysis of progression free survival, time to treatment failure and overall survival in a national cohort of patients with metastatic renal cell carcinoma treated in Denmark from 2006-2010 Safety, prognostic factors, predictive factors and co-morbidity assessed by Charlson Comorbidity Index.

The following drugs will be evaluated: Sunitinib, Sorafenib, Temsirolimus, Everolimus, Aldesleukin, Interferon-alfa-2b.

Detailed description: No sampling. All eligible patients will be included.

Eligibility criteria: Inclusion Criteria:

Metastatic renal cell carcinoma

Exclusion Criteria:

None

Primary outcomes:
measure: Overall survival from initiation of first systemic anticancer therapy
timeFrame: 8 months
measure: Progression free survival from initiation of each systemic anticancer therapy separately
timeFrame: 8 months
measure: Time to treatment failure from initiation of each systemic anticancer therapy separately
timeFrame: 8 months
Secondary outcomes:
measure: Prognostic factors at baseline associated with efficacy (PFS) of each systemic anticancer therapy and overall survival
timeFrame: 8 months
measure: Serious Adverse Events: Defined as AEs leading to dose adjustment, treatment interruption/ cessation or death.
timeFrame: 8 months
measure: Predictive factors
timeFrame: 8 months
measure: Co-morbidity assessed by Charlson Comorbidity Index
timeFrame: 8 months
measure: Combined PFS and OS on sequential treatment
timeFrame: 8 months
measure: Assessment of first line immunotherapy´s effect on second line targeted therapy
timeFrame: 8 months
measure: Assessment of prognostic factors and overall survival for patients not receiving systemic therapy
timeFrame: 8 months
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: University of Copenhagen Herlev Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03757962: Evaluation of Food Additive Contributions to Obesity - Feasibility Study 1
Official title: Evaluation of Food Additive Contributions to Obesity - Feasibility Study 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: dietary modification
Lead sponsor: McMaster University
Sponsor class: OTHER
First posted: 2018-11-29
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The effects of food additives on body weight in humans are largely unknown. This is a before-and-after feasibility study in 5 obese adults who will be followed for 5 months. Eligible participants will meet with the study team and will be taught how to limit the exposure to the studied food additives in their diet. Participants will also be asked to limit eating out to a maximum of 2 days per week. Primary outcomes in this study are recruitment rate, retention rate and adherence to the proposed dietary intervention.


Eligibility criteria: Inclusion Criteria:

* BMI\>/=30 kg/m2
* willingness and ability to follow the proposed dietary intervention
* informed consent

Exclusion Criteria:

* previous or planned bariatric surgery in the next 1 year
* current or planned participation in any structured weight-loss programs in the next 6 months
* current or recent (within the last 6 months) use of weight-loss-inducing drugs or systemic steroids
* bipolar disorder or attention deficit hyperactivity disorder
* current use of anti-depressant or anti-psychotic medications
* eating disorder or any other active disorder that may lead to significant weight changes
* working night shifts
* pregnancy or planned pregnancy in the next 1 year
* uncontrolled diabetes mellitus or diabetes requiring treatment with \>2 oral diabetes medications or with insulin

Primary outcomes:
measure: Recruitment rate
timeFrame: 0 months
measure: Retention rate
timeFrame: 5 months
measure: Adherence to the dietary intervention
timeFrame: 2 to 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
References:
Clinical trial NCT05098262: Phamacokinetics and Safety Profiles of DA-5210 10/500mg in Healthy Subjects at Fasting State
Official title: An Open Label, Randomized, Single Dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of DA-5210 10/500mg in Healthy Subjects at Fasting State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-10-28
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Phamacokinetics and Safety Profiles of DA-5210 10/500mg in Healthy subjects at Fasting State


Eligibility criteria: Inclusion Criteria:

* Healthy Volunteers
* BMI between 18 and 30 kg/m2
* Body weight : Male≥50kg, Female≥45kg

Exclusion Criteria:

* Allergy or Drug hypersensitivity
* Clinically significant Medical History

Primary outcomes:
measure: AUCt
timeFrame: pre-dose~48 hours post-dose
measure: Cmax
timeFrame: pre-dose~48 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: H Plus Yangji Hospital
Study officials:
References:
Clinical trial NCT05046262: Calcium Electroporation for Basal Cell Carcinomas - Proof of Concept Study
Official title: Calcium Electroporation for Basal Cell Carcinomas - Proof of Concept Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Basal Cell Carcinoma
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
Collaborators: name: Mirai Medical, Ireland
First posted: 2021-09-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 25 patients with primary low-risk basal cell carcinoma treated with calcium electroporation

Detailed description: 25 patients with primary low-risk basal cell carcinoma treated with calcium electroporation, if partial or no response after 3 months the treatment was repeated. Follow-up 3 and 12 months after last treatment.

Eligibility criteria: Inclusion Criteria:

Primary low risk basal cell carcinoma less than 3 cm in diameter

-

Exclusion Criteria:

Immunosuppression or organ transplant recipients Pregnancy or breastfeeding Allergy to local anesthetics

Primary outcomes:
measure: complete response
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Dermatology, Bispebjerg Hospital
Study officials:
References:
Clinical trial NCT02509962: Increased Salt Intake in Healthy Men
Official title: Effects of Increased Salt Intake on Metabolic, Cardiovascular and Immunoregulatory Functions in Healthy Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Energy metabolism
Glucose tolerance
Blood pressure
Immunoregulation
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2015-07-28
Enrollment: 14
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To study the effects of an increased salt intake on metabolic, cardiovascular and immunoregulatory functions in healthy men.


Eligibility criteria: Inclusion Criteria:

* body mass index 18.5 - 29.9 kg/m2

Exclusion Criteria:

* clinically relevant heart, lung, liver, and kidney diseases

Primary outcomes:
measure: Postprandial energy expenditure within 4h after a meal, measured by indirect calorimetry (respiratory chamber)
timeFrame: Change to baseline at day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Experimental & Clinical Research Center
Study officials:
affiliation: Charite University, Berlin, Germany
name: Michael Boschmann, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wilck N, Matus MG, Kearney SM, Olesen SW, Forslund K, Bartolomaeus H, Haase S, Mahler A, Balogh A, Marko L, Vvedenskaya O, Kleiner FH, Tsvetkov D, Klug L, Costea PI, Sunagawa S, Maier L, Rakova N, Schatz V, Neubert P, Fratzer C, Krannich A, Gollasch M, Grohme DA, Corte-Real BF, Gerlach RG, Basic M, Typas A, Wu C, Titze JM, Jantsch J, Boschmann M, Dechend R, Kleinewietfeld M, Kempa S, Bork P, Linker RA, Alm EJ, Muller DN. Salt-responsive gut commensal modulates TH17 axis and disease. Nature. 2017 Nov 30;551(7682):585-589. doi: 10.1038/nature24628. Epub 2017 Nov 15.
citation: Geisberger S, Bartolomaeus H, Neubert P, Willebrand R, Zasada C, Bartolomaeus T, McParland V, Swinnen D, Geuzens A, Maifeld A, Krampert L, Vogl M, Mahler A, Wilck N, Marko L, Tilic E, Forslund SK, Binger KJ, Stegbauer J, Dechend R, Kleinewietfeld M, Jantsch J, Kempa S, Muller DN. Salt Transiently Inhibits Mitochondrial Energetics in Mononuclear Phagocytes. Circulation. 2021 Jul 13;144(2):144-158. doi: 10.1161/CIRCULATIONAHA.120.052788. Epub 2021 Apr 28.
Clinical trial NCT07017062: Clinical Evaluation of Hybrid Ceramic Occlusal Veneers Bonded With Two Self Adhesive Resin Cements
Official title: Clinical Evaluation of Hybrid Ceramic Occlusal Veneers Bonded With Two Self Adhesive Resin Cements A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Occlusal Wear of Teeth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-06-12
Enrollment: 44
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized clinical trial aims to evaluate the clinical performance of hybrid ceramic occlusal veneers cemented with two different bonding protocols: a self-adhesive bonding protocol with adhesive enhancement (BeautiLink SA cement with BeautiBond Xtreme adhesive) versus another self-adhesive bonding protocol (RelyX U200 self-adhesive resin cement with 3M UNIVERSAL bond).


Eligibility criteria: Inclusion Criteria:

* • Age ≥ 21 years

  * Vital teeth
  * Sufficient tooth structure for veneer retention
  * Willing and able to provide written informed consent
  * Ability to attend all follow-up appointments
  * Adequate oral hygiene as determined by the investigator

Exclusion Criteria:

* • Patients with active periodontal disease (probing depth \> 4mm, bleeding on probing)

  * Patients with severe parafunctional habits (e.g., bruxism confirmed by clinical examination)
  * Poor oral hygiene (plaque index \> 30%)
  * Pregnancy or nursing
  * Systemic diseases affecting treatment outcomes (e.g., uncontrolled diabetes, immunosuppression)
  * Known allergies to study materials (ceramic, or resin cement components)
  * Inability to comply with study requirements
  * Current participation in other dental clinical trials
  * Active orthodontic treatment

Primary outcomes:
measure: Marginal discoloration
timeFrame: 18 months
Secondary outcomes:
measure: Retention
timeFrame: 18 months
measure: Marginal adaptation
timeFrame: 18 months
measure: Postoperative hypersensitivity
timeFrame: 18 months
measure: Recurrent caries
timeFrame: 18 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
References:
Clinical trial NCT03213262: Is Anxiety Affect the Anesthesia Type Performed In Patients During Caeserean Section ?
Official title: Is Anxiety Affect the Anesthesia Type Performed In Patients During Caeserean Section ?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2017-07-11
Enrollment: 138
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Ceserean patients

Brief summary: In this study, investigators wanted to investigate the effect of preoperative anxiety level on anesthesia preference of patient. Before surgery, patients will fill the forms of Pain catastrophising scale (PCS), Beck depression and Beck anxiety scale. After surgery, these forms will be evaluated according to the choice of anesthesia.

Detailed description: Anxiety is present due to many gait in the preoperative period. In studies that investigated anxiety levels in the preoperative period was found that 60-80% of the patients had significant anxiety. The present study is aimed to investigate the effect of preoperative anxiety level on anesthesia preference of cesarean patients. After approval, patients enrolled in the study is invited to complete the Pain Catastrophizing Scale questionnaire, Beck depression and Beck anxiety scale. After surgery, The effect of anxiety on the choice of anesthesia will be evaluated (general or spinal anesthesia).

Eligibility criteria: Inclusion Criteria:

* Between 18 and 40 years
* Planned to undergo ceserean
* An American Society of Anesthesiologists score of 1 or 2

Exclusion Criteria:

* Psychiatric diseases
* Rejected to participation

Primary outcomes:
measure: Anesthesia preference and anxiety
timeFrame: one time in three months
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Gaziosmanpasa university
Study officials:
affiliation: Gaziosmanpasa university
name: Hakan Tapar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06663462: EzPAP Therapy Versus Non-invasive Ventilation Therapy
Official title: EzPAP Therapy Versus Non-invasive Ventilation for Hypercapnic Chronic Obstructive Pulmonary Disease Exacerbataion: a Randomized Clinical Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Invasive Ventilation
Keywords: Chronic Obstructive Pulmonary dissease
Non-invasive ventilation
EzPAP
Lead sponsor: Kırklareli University
Sponsor class: OTHER
First posted: 2024-10-29
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: COPD disease

Brief summary: This study compared EzPAP and noninvasive treatments of hypercapnic COPD attacks.

Detailed description: In this study, the effectiveness of NIV and EzPAP treatments was compared in patients admitted to the emergency department due to hypercapnic COPD exacerbation. Blood gas was taken at the 4th and 24th hours of treatment to evaluate the effectiveness.

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of Chronic obstructive pulmonary disease Dyspnea

Exclusion Criteria:

Cardiac failure Dead

Primary outcomes:
measure: Blood gas
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Kirklareli
country: Turkey
facility: Oya Guven, MD
state: Center
Study officials:
affiliation: Kırklareli Training and Research Hospital
name: Gökhan Karakurt, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02586662: Prediction of Functional Disability in Subjects With Scapular Dyskinesis
Official title: Prediction of Functional Disability in Subjects With Scapular Dyskinesis: Shoulder Tightness, Forward Shoulder Posture, Joint Range of Motion, Scapular Kinematics and Associated Muscular Activity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Scapular Dyskinesis
Keywords: scapular dyskinesis
kinematics
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2015-10-26
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Function-related factors in patients with scapular dyskinesis. Fifty-one participants (40 males; 11 females; mean age= 22.5±2.4 years; mean height=171.4 ± 8.0 cm; mean weight= 64.9 ± 10.5 kg) were recruited.

Brief summary: Background: Patterns of scapular dyskinesis have unique scapular kinematics and associated muscular activation. The characteristics of scapular dyskinesis may be associated with functional disability. The investigators investigated whether the level of shoulder function and primary dysfunction items were different in each unique pattern of scapular dyskinesis. The factors associated with shoulder dysfunction in different patterns of scapular dyskinesis were identified.

Methods: Participants with unilateral shoulder pain were classified as having a single dyskinesis pattern (inferior angle prominence, pattern I; medial border prominence, pattern II) or a mixed dyskinesis pattern (patterns I+II). Clinical measurements with the Flexilevel Scale of Shoulder Function (FLEX-SF score), shoulder range of motion, anterior/posterior shoulder tightness, and pectoralis minor index were recorded. These clinical measurements, 3-D scapular kinematics (electromagnetic-based motion analysis), and associated muscular activation (electromyography on the upper, middle, and lower parts of the trapezius and serratus anterior muscles) during arm elevation were analyzed for associations with functional disability.


Eligibility criteria: Inclusion Criteria:

* Subjects were from 18 to 50 years old and had unilateral shoulder pain around the shoulder complex, including the glenohumeral, scapulothoracic, sternoclavicular, and acromioclavicular regions, while performing shoulder movement.

Exclusion Criteria:

* Subjects were excluded if they had a history of shoulder dislocation, fracture, or shoulder surgery within the past 1 year, or a history of direct contact injury to the neck or upper extremities within the past 1 month. Subjects who had neurological disorders or demonstrated pain (VAS\>3) during the overall testing procedures were also excluded.

Primary outcomes:
measure: Shoulder Function Questionnaire
timeFrame: one year
measure: Range of Motion on shoulder, range in degrees
timeFrame: one year
measure: Pectoralis Minor Index (PMI)
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: