louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04761328: Fear of Recurrence and Stopping Immunotherapy
Official title: Distress Associated with Stopping Immunotherapy of Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Behavioral Therapy
Keywords: Fear of recurrence
Quality of life
Depression
Anxiety
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients will receive treatment and be evaluated pre- and post-treatment
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study includes participants experiencing distress with regard to stopping immunotherapy and will utilize cognitive-behavioral therapy to reduce fear of recurrence, depression, and anxiety and improve quality of life.

Detailed description: The intervention will be delivered through telemedicine to reduce the patient-related barriers to treatment including cost, transportation, and being able to maintain appointments while managing the side effects of treatment. The intervention will provide the patient with skills to reduce distress associated with ceasing treatment of a checkpoint inhibitor through the development evidence-based psychological and behavioral strategies that are tailored to the patients' preferences.

Eligibility criteria: Inclusion Criteria:

* Age 21 years and older
* Fluent in English
* Diagnosis of cancer and history of treatment with immunotherapy

Exclusion Criteria:

* Active suicidal ideation, delusions or hallucinations

Primary outcomes:
measure: Reduce fear of recurrence
timeFrame: 3 months
Secondary outcomes:
measure: Improve quality of life
timeFrame: 3 months
measure: Reduction of anxiety
timeFrame: 3 months
measure: Depressive symptoms
timeFrame: 3 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Centers
state: Pennsylvania
Study officials:
affiliation: Hillman Cancer Center
name: Jason Luke
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04581928: Patients Reactions Towards Their Diagnosis as Having COVID-19
Official title: Patients Reactions Towards Their Diagnosis as Having COVID-19: A Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Covid19
Lead sponsor: ClinAmygate
Sponsor class: OTHER
First posted: 2020-10-09
Enrollment: 3812
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All COVID-19 cases

Brief summary: Patients reactions towards their diagnosis as having COVID-19. The effect of patients' reaction toward their prospect management. How this can make many hazards. Also, obstacle and barrier to better management.

Detailed description: Patients reactions towards their diagnosis as having COVID-19. The effect of patients' reaction toward their prospect management. How this can make many hazards. Also, obstacle and barrier to better management.

Different factors affecting the response of people toward their diagnosis as COVID-19

Eligibility criteria: Inclusion Criteria:

* COVID-19
* Age 18 years of less

Exclusion Criteria:

* Mental diseases making the communication with them difficult

Primary outcomes:
measure: Time to recovery
timeFrame: Four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Maadi
country: Egypt
facility: Asalam
state: Cairo
Study officials:
affiliation: Assalam Clinics
name: Emad R Issak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wiseman EJ. Denial in the medical interview. JAMA. 1995 Jun 14;273(22):1735; author reply 1735-6. doi: 10.1001/jama.273.22.1735. No abstract available.
Clinical trial NCT00655928: Modulation of Lung Injury Complicating Lung Resection
Official title: Modulation of Lung Injury Complicating Lung Resection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Lung Injury
Keywords: Acute lung injury
Lung resection
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Royal College of Physicians
name: Royal Brompton & Harefield NHS Foundation Trust
First posted: 2008-04-10
Enrollment: 52
Sex: ALL
Minimum age (years): 18
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 determine whether N-acetylcysteine given intravenously 1 day pre-operatively is effective in preventing inflammation in the lungs, as measured by tests on blood, breath and lung specimens, in patients undergoing surgery to remove a portion of lung.

Detailed description: Acute lung injury occurs following lung resection in about 5% cases, and has a high mortality of around 50%. Management of these patients is largely supportive. Even in patients who do not develop clinical evidence of acute lung injury, markers of inflammation and oxidative stress are present in blood and exhaled breath condensate after lung resection. The purpose of this randomised double-blind placebo-controlled study is to determine whether lung injury can be prevented by pre-administration of N-acetylcysteine.

Eligibility criteria: Inclusion Criteria:

* Elective lung resection for cancer

Exclusion Criteria:

* Age less than 18 years
* Women of child-bearing age or potential
* Known allergy to N-acetylcysteine
* Oral steroid in the preceding 1 month
* N-acetylcysteine in the preceding 1 month
* Unable to receive standardised anaesthetic approach

Primary outcomes:
measure: Post-operative Plasma IL-6
timeFrame: Post operative, 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton Hospital
Study officials:
affiliation: Imperial College London
name: Mark J Griffiths
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bastin AJ, Davies N, Lim E, Quinlan GJ, Griffiths MJ. Systemic inflammation and oxidative stress post-lung resection: Effect of pretreatment with N-acetylcysteine. Respirology. 2016 Jan;21(1):180-7. doi: 10.1111/resp.12662. Epub 2015 Oct 27.
Clinical trial NCT01233128: Vascular Endothelial Growth Factor (VEGF) & LOC387715/HTRA1 Polymorphism in Polypoidal Choroidal Vasculopathy
Official title: Association of Vascular Endothelial Growth Factor and LOC387715/HTRA1 Polymorphisms With the Response to Intravitreal Ranibizumab Injections in Polypoidal Choroidal Vasculopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-Related Macular Degeneration
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2010-11-03
Enrollment: 121
Sex: ALL
Minimum age (years): 60
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: The authors did a retrospective chart review of 70 patients with PCV who visited the Department of Ophthalmology, Kyungpook National University Hospital in Daegu, Korea.

Brief summary: This study is to investigate whether there is an association of the LOC387715/HTRA1 and vascular endothelial growth factor polymorphism with response to treatment with intravitreal ranibizumab injections for patients with polypoidal choroidal vasculopathy.

Detailed description: This is a retrospective comparative case series comprised of 70 patients being treated for polypoidal choroidal vasculopathy with intravitreal ranibizumab injections and 112 control subjects. Patients were genotyped for the LOC387715 (rs10490924), HTRA1 gene (rs11200638), and VEGF (rs3025039 and rs833069)polymorphism using Real-Time polymerase chain reaction.

Eligibility criteria: Inclusion Criteria:

* patients older than 60 years of age at onset
* polyp-like terminal aneurysmal dilations with or without branching vascular networks in ICGA and subretinal reddish-orange protrusions corresponding to polyp-like lesions
* patients who had intravitreal injections of 0.5 mg of ranibizumab monthly for 3 months

Exclusion Criteria:

* patients with retinal or choroidal diseases including pathologic myopia, angioid streaks, idiopathic choroidal neovascularization (CNV), presumed ocular histoplasmosis, and other secondary CNV
* patients who refused genotypic analyses

Primary outcomes:
measure: Best-corrected visual acuity
timeFrame: up to 12 months
Secondary outcomes:
measure: Angiographic characteristics
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: In Taek Kim
state: Kyungsangpookdo
Study officials:
affiliation: Kyungpook National University Hospital
name: In Taek Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Immonen I, Seitsonen S, Tommila P, Kangas-Kontio T, Kakko S, Savolainen ER, Savolainen MJ, Liinamaa MJ. Vascular endothelial growth factor gene variation and the response to photodynamic therapy in age-related macular degeneration. Ophthalmology. 2010 Jan;117(1):103-8. doi: 10.1016/j.ophtha.2009.06.037. Epub 2009 Nov 6.
Clinical trial NCT00453128: Diagnostic Rentability of Screening for Associated Conditions in Calcium Pyrophosphate Deposition Disease Patients
Official title: Appraisal of the Diagnostic Rentability of Thorough Analytical Screening Searching Associated Conditions in Patients Newly Diagnosed With Calcium Pyrophosphate Dihydrate Deposition Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chondrocalcinosis
Keywords: Calcium Pyrophosphate
associated conditions
Lead sponsor: Sociedade Galega de Reumatoloxía
Sponsor class: OTHER
First posted: 2007-03-28
Enrollment: 240
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to determine whether thorough analytical evaluation is useful to diagnose metabolic conditions associated to calcium pyrophosphate deposition disease.

Detailed description: The diagnostic usefulness of screening for hyperparathyroidism, hemochromatosis, hypothyroidism and hypophosphatasia in patients diagnosed with calcium pyrophosphate dihydrate (CPPD) deposition disease is uncertain.

Patients diagnosed with CPPD deposition disease were compared to patients with rheumatoid arthritis and psoriatic arthritis over a 9-year period. All patients were prospectively followed for at least 12 months. Serum calcium, phosphorus, alkaline phosphatase, thyroid-stimulating hormone, ferritin, iron, and total iron binding capacity were determined in all patients.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed as having calcium pyrophosphate dihydrate deposition disease.

Exclusion Criteria:

* Patients mimicking a rheumatoid arthritis disease, with positive rheumatoid factor or with psoriasis.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vigo
country: Spain
facility: Meixoeiro Hospital
state: Pontevedra
Study officials:
affiliation: Meixoeiro Hospital, Vigo (Pontevedra) SPAIN
name: José M Pego-Reigosa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04442828: 3D Echocardiography and Cardiovascular Prognosis in Mitral Regurgitation
Official title: 3D Echocardiography and Cardiovascular PRognosis In Mitral REgurgitation (3D-PRIME)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mitral Regurgitation
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2020-06-23
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A cohort of patients with chronic mitral regurgitation referred for clinical and echocardiographic assessment at the Heart Valve Clinic at Haukeland University Hospital in Bergen, Norway.

Brief summary: The 3D-PRIME study will analyse whether use of 3D echocardiography can improve risk stratification and cardiovascular outcome in patients with mitral regurgitation of different etiologies.


Eligibility criteria: Inclusion Criteria:

* Adult patients with primary or secondary mitral regurgitation (MR)
* MR of moderate or severe degree
* 3D echocardiographic examinations of \>= good spatial and temporal resolution

Exclusion Criteria:

* Co-existence of another valve disease of severe degree
* Inability to give informed consent

Primary outcomes:
measure: Major cardiovascular event
timeFrame: 24 months
Secondary outcomes:
measure: All-cause death
timeFrame: 24 months
measure: Cardiovascular death
timeFrame: 24 months
measure: Mitral valve intervention
timeFrame: 24 months
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
References:
Clinical trial NCT01061528: Coping Skills Treatment for Smoking Cessation
Official title: Distress Tolerance Treatment for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nicotine Dependence
Keywords: cigarette smoking
smoking cessation
nicotine dependence
Lead sponsor: Butler Hospital
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-02-03
Enrollment: 116
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 purpose of this study is to evaluate the efficacy of a new type of exposure- and acceptance-based smoking cessation treatment vs. standard behavioral smoking cessation treatment, in conjunction with the use of the transdermal nicotine patch. In both treatments, participants will receive one 60-minute individual session, seven 2-hour group sessions and two individual brief telephone contacts over an eight-week period. Both treatments include 8 weeks of transdermal nicotine patch, which will begin at the time of quitting smoking and will continue after the treatment sessions have ended. Participants will provide follow-up data with regard to their smoking status through a one-year follow-up period.

Detailed description: 1. 18-65 years of age,
2. a regular smoker for at least one year,
3. currently smoking 10 or more cigarettes per day,
4. report motivation to quit smoking in the next month.

Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* regular smoker for at least one year
* currently smoking 10 or more cigarettes per day

Exclusion Criteria:

* Current Axis I disorder
* Psychoactive substance abuse or dependence (excluding nicotine dependence) within past year
* Current suicidal risk
* Pregnancy or breast feeding
* Use of nicotine replacement products or bupropion

Primary outcomes:
measure: Number of Participants With Biochemically Verified Smoking Abstinence
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Butler Hospital
state: Rhode Island
Study officials:
affiliation: Butler Hospital/Brown Medical School
name: Richard A Brown, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02105428: Potential Impact of Polycystic Ovarian Syndrome on Protein Modifications and Accumulation
Official title: Potential Impact of Polycystic Ovarian Syndrome on Protein Modifications and Accumulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovarian Syndrome (PCOS)
Insulin Resistance
Overweight
Obese
Keywords: Polycystic Ovarian Syndrome (PCOS)
Insulin Resistance
Overweight, Obese Women
Protein Metabolism
Post Translational Modifications
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-04-07
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A goal of this study is to use a novel methodology to determine whether insulin resistance in women with polycystic ovary syndrome (PCOS) is related to the accumulation of proteins with modifications. This could lead to future research to determine if these modifications interfere with their proper function. Additionally, the investigators will determine how protein quality is affected by exercise training. Aerobic exercise enhances the endogenous oxidant buffering systems which may minimize oxidative damage to proteins. The investigators propose that aerobic exercise minimizes the accrual of modified proteins by increasing the synthesis of new proteins, but also by increasing the degradation and removal of old and damaged proteins. Based on our previous studies the investigators observed that insulin affects plasma protein synthesis and aerobic exercise improves insulin sensitivity not only in muscle but also in liver. The investigators therefore propose that aerobic exercise and related increase in insulin sensitivity (and decline in insulin levels) will reduce accumulation of old and modified skeletal muscle and plasma proteins leading to improved function.


Eligibility criteria: Inclusion Criteria:

1. BMI between 25 kg/m2 and 40 kg/m2
2. Fasting blood glucose \< 126 mg/dL
3. Diagnosed with PCOS as outlined by the Rotterdam criteria
4. Insulin resistant as determined by a 3 hour oral glucose tolerance test

Exclusion Criteria:

1. Serum creatinine ≥1.5 mg/ dL.
2. Serum transaminase elevation ≥ 3 times the upper limit of normal range
3. Use of systemic glucocorticoids
4. Use of oral anticoagulation
5. Pregnancy

Primary outcomes:
measure: Change in insulin sensitivity
timeFrame: Measured before and after 12 weeks
Secondary outcomes:
measure: Protein modifications and accumulation
timeFrame: Before and after 12 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
Clinical trial NCT03123328: Evaluation of Non-Invasive Hemoglobin in Trauma Patients
Official title: Evaluation of Non-Invasive Hemoglobin in Trauma Patients Using FDA-Cleared Masimo Pulse CO-Oximeter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trauma
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-04-21
Enrollment: 380
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This is a prospective, non-blinded, non-randomized, interventional study of the Masimo pulse oximeter and sensors in a trauma setting

Detailed description: The study aimed to evaluate SpHb's ability to detect critical drops in a trauma population

Eligibility criteria: Inclusion Criteria:

* Estimated 16 years of age or older or greater than or equal to 50 kg body weight if age unknown.
* Level 1 (highest trauma activation) status at the time of arrival to emergency department (ED).
* Expected to be admitted to the ICU/IMU for in hospital care.

Exclusion Criteria:

* Moribund patients with devastating injuries and expected to die within one hour of ED admission.
* Prisoners, as defined as those who have been directly admitted from a correctional facility (a free living individual who is under police observation as a suspect will remain in the study until hospital discharge).
* Obvious pregnancy in the ED.
* Received greater than 5 minutes of cardiopulmonary resuscitation (CPR) in the pre-arrival or hospital setting.
* Has, on the ring, middle and index fingers of both hands, any of the following: finger deformities, injuries, including burns, scar tissue or infection, or any material that may interfere with sensor application or trans-illumination of the site.
* Has significant bilateral trauma to the arms or forearms.

Primary outcomes:
measure: SpHb's Ability to Detect Critical Drops
timeFrame: Up to 24 hours.
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas Health Science Center at Houston
state: Texas
Study officials:
References:
Clinical trial NCT04540328: Non-surgical Peridontal Treatment on Cardiovascular Risk Markers
Official title: Effect of Non-surgical Peridontal Treatment on Cardiovascular Risk Markers in Patients With Severe Chronic Periodontitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Risk Markers
Chronic Periodontitis
Keywords: asymmetric dimethylarginine
endothelial nitric oxide synthase
homocysteine
monocyte chemoattractant protein-1
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2020-09-07
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study evaluates the influence of non-surgical mechanical periodontal treatment in patients with severe chronic periodontitis on inflammatory markers related to risk for cardiovascular diseases

Detailed description: A total of 80 non-smokers with systemically healthy, including 40 patients with severe chronic periodontitis and 40 periodontally health subjects were included into the present study. The probing depth, clinical attachment level, plaque index, gingival index and blood samples were collected at baseline and at the 3rd months after treatment and the serum levels of asymmetric dimethylarginine (ADMA), endothelial nitric oxide synthase (eNOS), homocysteine (Hcy), monocyte chemoattractant protein-1 (MCP-1) were determined with enzyme-linked immunosorbent assay (ELISA).

Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of severe chronic periodontitis

Clinical diagnosis of periodontal health

Exclusion Criteria:

Systemic diseases such as diabetes, cardiovascular disease

Periodontal treatment within the previous year

Drugs such as systemic steroids, non-steroidal anti-inflammatory drugs, immunosuppressants, hormone drugs, contraceptives, anticoagulants, cholesterol regulating drugs, systemic antibiotics, antioxidants within the previous 3 months

Pregnant or lactating

Consumed alcohol

Smoker

Primary outcomes:
measure: Asymmetric dimethylarginine (ADMA)
timeFrame: At the 3rd months after non-surgical periodontal treatment
measure: Endothelial nitric oxide synthase (eNOS)
timeFrame: At the 3rd months after non-surgical periodontal treatment
measure: Homocysteine (Hcy)
timeFrame: At the 3rd months after non-surgical periodontal treatment
measure: Monocyte chemoattractant protein-1 (MCP-1)
timeFrame: At the 3rd months after non-surgical periodontal treatment
Secondary outcomes:
measure: Clinical periodontal parameter
timeFrame: At the 3rd months after non-surgical periodontal treatment
Other outcomes:
Locations:
Study officials:
References: