louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02280161: Germ-Line Mutations in Blood and Saliva Samples From Patients With Cancer
Official title: An Investigation of the Role of Germ-Line Mutations in Cancer Predisposition, Tumor Biology, and Response to Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malignant Neoplasm
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-10-31
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults with a confirmed diagnosis of cancer.

Brief summary: This research trial studies germ-line mutations in blood and saliva samples from patients with cancer. Studying samples of blood and saliva from patients with cancer in the laboratory may help doctors learn more about how inherited genetic mutations can affect cancer predisposition (an inherited increase in the risk of developing cancer), their impact on treatment response, and their role in cancer development.

Detailed description: PRIMARY OBJECTIVES:

I. To collect germ-line deoxyribonucleic acid (DNA) and nucleic acids from cancer patients to further investigate the association and identify new germ-line mutations that impact cancer predisposition.

II. To investigate the role of germ-line mutations in predicting cancer outcome and response to therapy.

SECONDARY OBJECTIVES:

I. To determine the effect of the identified variants on tumor micro-ribonucleic acid (miRNA), protein and gene expression.

II. To study expression of DNA, ribonucleic acid (RNA) or protein in the blood of cancer patients with and without variants of interest to discover correlations between such levels and the presence of cancer and/or response to therapy in these patients.

OUTLINE:

Patients undergo collection of blood and saliva samples 1-3 times at the discretion of the investigator for germ-line mutation analysis.

After completion of study, patients are followed up for 5 years.

Eligibility criteria: Inclusion Criteria:

* Pathologically or clinical confirmed tissue diagnosis of a cancer
* Ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Patients will be excluded if their cancer cannot be confirmed
* Refusal to sign the informed consent

Primary outcomes:
measure: Prevalence of germ-line variants
timeFrame: Up to 5 years
measure: Overall genotype frequencies
timeFrame: Up to 5 years
measure: Response to treatment
timeFrame: Up to 5 years
measure: Cancer development
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: Jonsson Comprehensive Cancer Center
name: Joanne Weidhaas
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02928861: 18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Diffuse Large B-cell Lymphoma
Official title: 18F-FDG PET/CT-based Prognostic Model for Predicting Outcome in Patients With Diffuse Large B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lymphoma, Large B-Cell, Diffuse
Keywords: Positron-Emission Tomography
Prognosis
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2016-10-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate whether 18F-FDG PET/CT-based prognostic model of diffuse large B-cell lymphoma can predict disease progression

Detailed description: In this study investigators develop a prognostic model based on 18F-FDG PET/CT and test its ability for prognostic value in patients with DLBCL. PET/CT scans evaluation using the liver SUVmax as reference. Positive lesions in PET were indicated as SUVmax of residues higher than the threshold (1.6 fold of liver SUVmax) or new 18F-FDG avid lesions. 18F-FDG PET/CT-based prognostic model includes PET/CT image, dominant clinical and pathological prognostic factors to predicting disease progression during chemotherapy or survival in DLBCL.

Eligibility criteria: Inclusion Criteria:

1. newly diagnosed DLBCL;
2. treated using an anthracycline-containing regimen with or without rituximab;
3. minimal follow-up at 6 months after the completion of first-line treatment;
4. complete medical history and clinicopathological data

Exclusion Criteria:

1. secondary malignant disease;
2. serious infection or inflammation (e.g., HIV);
3. primary central nervous system lymphoma;
4. hepatic or renal dysfunction.

Primary outcomes:
measure: 2 year progression-free survival
timeFrame: up to 2 years after initial diagnosis
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Cancer Hospital
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Xuejuan Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yuan T, Zhang Y, Chen X, Wei M, Zhu H, Song Y, Yang Z, Zhu J, Wang X. Risk Assessment in Diffuse Large B-Cell Lymphoma by Combining Baseline Metabolic Tumor Volume and Peking Criteria When Evaluating Series 18F-Fluorodeoxyglucose Positron Emission Tomography Scans. Front Oncol. 2022 Apr 21;12:876581. doi: 10.3389/fonc.2022.876581. eCollection 2022.
Clinical trial NCT05973461: Effects of Exercise and Virtual Reality on Depression
Official title: Effects of Exercise With Virtual Reality on Females and Males With or Without Depression
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Symptoms of Depression
Lead sponsor: The University of Texas at Arlington
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: males and females, with and without symptoms of depression
Primary purpose: SCREENING

Brief summary: This study is evaluating the effects of riding on a cycle ergometer while experiencing virtual reality to determine its effect on mood.

Detailed description: Adults (males and females) above the age of 18 yrs will be recruited to determine if they have symptoms of depression based on a questionnaire (Center for Epidemiologic Studies - Depression Scale (CES-D). They will then complete a Beck Inventory before and after the exercise. Participants will be divided into groups either having symptoms of depression or not. They will be randomized to ride on a cycle ergometer with or without using Virtual Reality (VR) that will allow them to view neighborhoods or parks during the exercise. The ergometer will be set at resistance raising the heart rate to 65% of their age-predicted heart rate maximum. They will ride for 20 min and then complete the Beck Inventory to determine any changes in their depressive symptoms.

Eligibility criteria: Inclusion Criteria:

* Males and females over the age of 18 years
* With or without symptoms of depression
* Physically inactive or sedentary (less than 30 minutes per day)
* Normal vision and no color blindness
* No physical disorders such as walking with assistance

Exclusion Criteria:

* Below the age of 18 years or over 65 years,
* Women who are pregnant
* Individuals who have been diagnosed with mental disorders
* Individuals with leg injuries
* Individuals with cardiac problems
* Individuals with a history of asthma
* Individuals with a body mass index over 30.

Primary outcomes:
measure: Beck Depression Inventory Scale of Measurement
timeFrame: 5 minutes
measure: Spatial Working Memory (SWM)
timeFrame: 8 minutes
measure: Neuropsychological Outcomes: Motor Screen Tasks (MOT)
timeFrame: 3 minutes
Secondary outcomes:
measure: Neuropsychological Outcomes: MOT Mean Latency, MOT Total Correct, and MOT Total Errors
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Arlington
country: United States
facility: UTArlington
state: Texas
Study officials:
affiliation: UTArlington
name: Judy R Wilson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05098561: Music Therapy for Post-cardiac Surgery Pain Management
Official title: Music Therapy as a Supplement to Post Surgery Pain Management in Cardiac Surgery Patient Following Median Sternotomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Opioid Use
Lead sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Randomize patients into music treatment group and non-music treatment control group. 30 patients per group. Patients will be enrolled into each group on an alternate bases.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Music therapy as a supplement to post surgery pain management in cardiac surgery patients following median sternotomy.

Detailed description: 2. Specific Aims:

1. Primary Aim: To assess whether music therapy can decrease the amount of opioid type pain medications used.

   Hypothesis: Music therapy reduces the amount of opioid type pain medication used in management of post-operative pain and discomfort.
2. Secondary Aims:

i. To identify the gender and age groups of patients who can benefit from music therapy as a supplement to post-operative pain management.

Hypothesis: Majority of the population of patient benefits from music therapy as a supplement to postoperative pain management.

ii. To assess whether music therapy can increase patient satisfaction.

Hypothesis: Music therapy increases patient satisfaction.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing cardiac surgery via median sternotomy

Exclusion Criteria:

* Emergency cases.
* Patients with hearing impairment.
* Patients with dementia or other mental status changes.
* Patients who are clinically unstable postoperatively.
* Patients who develop postoperative complications.
* Patients who are non-English speaking.

Primary outcomes:
measure: The amount of Opioid type pain medication used
timeFrame: In the immediate post operative period, while patient still in the ICU
Secondary outcomes:
Other outcomes:
Locations:
city: Brighton
country: United States
facility: Steward St. Elizabeth medical Center
state: Massachusetts
Study officials:
affiliation: Steward St Elizabeth Medical Center
name: Stanley Tam
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05934461: A Retrospective Study of Radiotherapy Combined With EGFR-TKI for Stage III EGFR Mutant Lung Cancer
Official title: A Retrospective Study of Radiotherapy Combined With EGFR-TKI for Stage III EGFR Mutant Lung Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Primary Study Metric is Progression-free Survival (PFS)
Lead sponsor: Laibin People's Hospital
Sponsor class: OTHER
First posted: 2023-07-07
Enrollment: 48
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 diagnosed with lung cancer by pathology,genetic testing for EGFR mutation type

Brief summary: Objective: To investigate the efficacy and safety of radiotherapy combined with EGFR-KI in the treatment of stage III EGFR mutant lung cancer. Methods: Stage III EGFR mutant lung cancer cases who underwent radiotherapy combined with EGFR-TKI from December 2014 to December 2022 at the People's Hospital of Laibin, the First People's Hospital of Yulin, the Affiliated Hospital of Guilin Medical College, and the Park East Hospital of Guangxi Medical University Kaiyuan were collected, and the primary index of the study was progression-free survival (PFS), and the secondary indexes were objective remission rate, overall survival, recurrence pattern, and adverse events. Survival analysis was performed using the Kaplan-Meier method with Log rank test for univariate analysis and Cox proportional risk model for multifactorial analysis of prognosis.


Eligibility criteria: Inclusion Criteria:

* ①patients diagnosed with lung cancer by pathology; ②genetic testing for EGFR mutation type; ③compliance with the international eighth edition of lung cancer TNM stage IIIA-IIIC; ④treatment modality of radiotherapy + targeted therapy. ⑤Eastern Cooperative Oncology Group (ECOG) physical status score ≤ 2

Exclusion Criteria:

* (1) those who underwent surgery; (2) those who received chemotherapy. (3) Combination of other serious diseases that affect survival.

Primary outcomes:
measure: progression-free survival (PFS)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05279261: Clinical Effect of the Axillary Approach to Glenoid Fractures
Official title: Clinical Effect of the Axillary Approach to Acute Anterior Glenoid Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fracture; Glenoid
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Glenoid fractures result in glenohumeral post-trauma arthritis and instability. Operative treatment is indicated for severe fractures. The traditional deltopectoral approach, which requires detachment of the subscapularis, has many drawbacks, including loss of external rotation and suboptimal fixation. Arthroscopic techniques also cannot allow anatomic reduction and biomechanical stability for large fractures. We describe an alternative approach that enters from the axilla through the interval between the rotator cuff and the inferior glenoid, neck and lateral border of the scapula without detachment of the rotator cuff.


Eligibility criteria: Inclusion Criteria:

* Traumatic and closed fractures
* Fracture type conforms to Ideberg Ia classification or AO/OTA F1.1 classification
* Fracture displacement ≥4mm, the area of involvement ≥20%.

Exclusion Criteria:

* Severe multiple trauma
* Pathological fracture
* Unable to tolerate surgical treatment
* The interval between injury and operation was \> 2 weeks

Primary outcomes:
measure: fracture union
timeFrame: 6 months
measure: the Constant and Murley scores
timeFrame: 2 years
measure: the DASH(disabilities of the arm，shoulder and hand) scores
timeFrame: 2 years
Secondary outcomes:
measure: Complications
timeFrame: 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospita
Study officials:
References:
Clinical trial NCT00400361: A Multiple Ascending Dose Study of R1507 in Patients With Advanced Solid Tumors.
Official title: A Dose-escalation Study of R1507 in Patients With Advanced Solid Tumors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2006-11-16
Enrollment: 98
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: This study will determine the maximum tolerated dose and pharmacokinetic profile of R1507 in patients with metastatic or locally advanced malignant solid tumors, non-Hodgkin's lymphoma or Hodgkin's lymphoma. Groups of patients will be sequentially enrolled to receive ascending doses of R1507 either weekly or three-weekly by intravenous infusion. The starting dose of 1mg/kg iv for each dosing regimen will be escalated in subsequent groups of patients after a satisfactory assessment of safety, tolerability and pharmacokinetics of the previous dose. The anticipated time on study treatment is until disease progression or dose-limiting toxicity, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* solid neoplasm, non-Hodgkin's lymphoma or Hodgkin's lymphoma;
* metastatic or locally advanced disease, not curable by any currently available treatment.

Exclusion Criteria:

* severe, uncontrolled systemic disease;
* patients who require treatment with glucocorticoids or immunosuppressive treatment within last 6 months;
* patients with diabetes mellitus.

Primary outcomes:
measure: AEs, laboratory parameters, Cmax, Tmax, AUC, clearance, Vdss elimination half life
timeFrame: Throughout study
Secondary outcomes:
measure: Tumor response
timeFrame: Event driven
Other outcomes:
Locations:
city: Aurora
country: United States
state: Colorado
city: New Brunswick
country: United States
state: New Jersey
city: Houston
country: United States
state: Texas
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Xin Y, Xu F, Gao Y, Bhatt N, Chamberlain J, Sile S, Hammel S, Holt RJ, Ramanathan S. Pharmacokinetics and Exposure-Response Relationship of Teprotumumab, an Insulin-Like Growth Factor-1 Receptor-Blocking Antibody, in Thyroid Eye Disease. Clin Pharmacokinet. 2021 Aug;60(8):1029-1040. doi: 10.1007/s40262-021-01003-3. Epub 2021 Mar 26.
Clinical trial NCT05326061: Vienna HIV Infection Via Sex Study
Official title: Characterization of Patients at High Risk for the Acquisition of Sexually Transmitted Infection With the Human Immunodeficiency Virus (HIV) - a Clinical Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV Infections
HIV Pre-Exposure Prophylaxis
Sexually Transmitted Diseases
Gonorrhea
Chlamydia
Syphilis
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting at the HIV- and/or STI ward of the Department of Dermatology at General Hospital of Vienna which are characterized as individuals at high risk for acquiring HIV will be considered as potential participants for the HIVEX registry.

Brief summary: The main objective of this prospective observational cohort study is to investigate the epidemiology, the risk factors and ultimately the incidence of novel HIV infections among individuals at high risk for acquiring HIV via sex practices.

Detailed description: We will include individuals at high-risk for HIV acquisition, i.e. HIV-negative MSM and transgender individuals who (i) do not use condoms consistently with casual partners and/or with HIV-positive partners who are not on treatment and/or (ii) recently acquired an STI and/or (iii) recently used PEP and/or (iv) frequently engage in 'chemsex' within the past 12 months Important clinical information on possible vectors for transmission (including but not limited to high-risk sex practices and sexualized drug use), use of HIV pre-exposure prophylaxis, incidence of sexually transmitted infections will be assessed and laboratory parameters will be obtained from blood, urine and mucosal secretion.

Eligibility criteria: Inclusion Criteria:

1. High risk for acquiring HIV defined as followed: HIV-negative MSM and transgender individuals who (i) do not use condoms consistently with casual partners and/or with HIV-positive partners who are not on treatment and/or (ii) recently acquired an STI and/or (iii) recently used PEP and/or (iv) frequently engage in 'chemsex'.
2. Age \>18 years and \<100 years.
3. Written informed consent for this registry study.

Exclusion Criteria:

1. Withdrawal of the written informed consent.

Primary outcomes:
measure: Incidence of HIV
timeFrame: Up to 10 years (=Study Period)
Secondary outcomes:
measure: Incidence of sexually transmitted infections
timeFrame: Up to 10 years (=Study Period)
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT00802061: Sleep at 30 Degrees in Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: progressive glaucoma despite controlled IOP
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2008-12-04
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This study is designed to investigate the effect of body posture (particularly when sleeping) on the pressure in the eye. The effect of body posture on progressive glaucoma (glaucoma where a significant change i.e. a disc hemorrhage has occurred) is not known.

The study will involve being admitted to the Sleep Unit of the University Health Network at Toronto Western Hospital for 1 night (14 hours). IOP will be measured in both eyes every 2 hours with a Tonopen, along with brachial blood pressure (BP), in the sitting position until the patients reach their normal sleep cycle time. Patients will then be asked to sleep in either lying down or reclining at a 30 degrees position and have the IOP measurements and brachial BP every 2 hours in that position.

The same cohort of patients will then be invited for a repeat 14 hour IOP and BP measurement but will change their position, i.e. sitting before will now be supine and vice versa.


Eligibility criteria: Inclusion Criteria:

* This pilot study included patients with progressive NTG or POAG as evidenced by disc hemorrhage despite well controlled Intraocular pressures (IOP), who were able to sleep flat

Exclusion Criteria:

* Any patients who were not able to sign a consent or lying flat during sleep

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto Western Hospital
state: Ontario
Study officials:
References: