louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03131531: Bergamo Lymphoid Cancer Registry
Official title: Bergamo Lymphoid Cancer Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hodgkin Lymphoma
Non Hodgkin Lymphoma
Myeloma
Lead sponsor: A.O. Ospedale Papa Giovanni XXIII
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 6000
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: Patients eligible for this study are patients with a diagnosis of lymphoid cancer in charge of the Hematology and Bone Marrow Transplant Unit "Ospedale Papa Giovanni XIII" of Bergamo.

Brief summary: This registry has been established to gain a better understanding of the clinical and biological characteristics and outcome of patients with lymphoid cancer

Detailed description: Lymphoid cancer including Hodgkin disease, non-Hodgkin lymphomas (NHL) and myeloma, represents the most common hematologic malignancy. Despite the overall prognosis improved in the last 10 years, there are many open issues that need to be addressed, specifically refractoriness to standard treatment, disease recurrence and outcome with new drug in the so called "real world" setting. Since the Hematology and Bone Marrow Transplant Unit at "Ospedale Papa Giovanni XIII" of Bergamo has developed specific tools to collect clinical data thought fully validated electronic charts and biological specimens thanks to a regulatory compliant biobanking program, the aim of this study is to collect clinical and biological information of lymphoid cancer patients. The cohort of patients enrolled will permit to analyze the practice pattern, perform biological correlative studies of great translational potential with relevance to clinical practice.

Eligibility criteria: Inclusion Criteria:

* Male or female patients 18 years or older
* Written informed consent
* Confirmed diagnosis of Hodgkin disease, non-Hodgkin lymphomas or myeloma

Exclusion Criteria:

- Unconfirmed diagnosis of Hodgkin disease, non-Hodgkin lymphomas or myeloma

Primary outcomes:
measure: Overall survival
timeFrame: 20 years
Secondary outcomes:
measure: Disease-free survival
timeFrame: 20 years
measure: Progression-free survival
timeFrame: 20 years
measure: Biological correlative studies
timeFrame: 20 years
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Hematology and Bone Marrow Transplant Unit, A.O. Ospedale Papa Giovanni XXIII
Study officials:
affiliation: A.O. Ospedale Papa Giovanni XXIII
name: Alessandro Rambaldi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01605331: Safety and Efficacy of SR-hGH (Sustained-release Human Growth Hormone, Declage Inj.)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Growth Hormone Deficiency
Keywords: Adults
GH deficiency
Lead sponsor: LG Life Sciences
Sponsor class: INDUSTRY
First posted: 2012-05-24
Enrollment: 132
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: As studies demonstrate, the administration of recombinant human GH (rhGH) in adults with GH deficiency has been known to improve metabolic impairment and quality of life. Patients, however, do have to tolerate daily injections of GH (rhGH).


Eligibility criteria: Inclusion Criteria:

* Men and women aged ≥ 20 years with diagnosed GH deficiency (caused by pituitary tumor, trauma, other pituitary disease)

Primary outcomes:
measure: Safety
timeFrame: 12 weeks
Secondary outcomes:
measure: Efficacy
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01282931: Patient-reported Outcome Questionnaire for Women With Metastatic Breast Cancer
Official title: Development and Implementation of a Patient-reported Outcome Questionnaire to Assess the Value of Progression-free Survival for Women With Metastatic Breast Cancer.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Breast Cancer
Keywords: Women
Stage IV
Metastatic
Breast Cancer
Progressed
Progression
Lead sponsor: Health Outcomes Solutions
Sponsor class: OTHER
First posted: 2011-01-25
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female 18 and older U.S. resident Clinical diagnosis of metastatic breast cancer

Brief summary: The goal of the study is to understand the meaning of progression-free survival for women with metastatic breast cancer and to use this understanding to create and distribute a new questionnaire to assess the effect progression has on a woman's functioning and well-being.

Detailed description: This study is being conducted in three stages. Stages I and II are complete. Participation in Stage III requires the completion of an online survey. The survey may be accessed at the following link:

https://www.surveymonkey.com/s/mbc3survey

Compensation options for eligible participants are listed at the end of the survey.

Eligibility will be confirmed in follow-up call/email by study staff.

Eligibility criteria: Inclusion Criteria:

* Female
* Age 18 and older
* Clinical diagnosis of metastatic breast cancer
* U.S. resident
* Able to speak and read English
* Willing to sign and informed consent
* Willing to self-administer one online questionnaire that will take approximately 15 minutes to complete

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Winter Park
country: United States
facility: Health Outcomes Solutions
state: Florida
Study officials:
affiliation: Health Outcomes Solutions
name: Susan D. Mathias
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00372931: A Phase II Study of AL-37807 to Treat Open-Angle Glaucoma or Ocular Hypertension
Official title: A Phase II Study of AL-37807 to Treat Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-09-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether AL-37807 is safe and effective in treating patients with open-angle glaucoma or ocular hypertension


Eligibility criteria: Inclusion Criteria:

* Adult patients of either sex and any race with open-angle glaucoma or ocular hypertension; logMAR visual acuity not worse than 0.60; additionally clinically relevant ophthalmic or systemic conditions may be excluded

Exclusion Criteria:

* Under 18

Primary outcomes:
measure: Mean IOP change from baseline
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: San Antonio Site
state: Texas
Study officials:
affiliation: Study Director
name: Theresa Landry
role: STUDY_DIRECTOR
References:
Clinical trial NCT00350831: Study of XL820 Given Orally Daily to Subjects With Solid Tumors
Official title: A Phase 1 Dose Escalation Study of the Safety and Pharmacokinetics of the KIT Inhibitor XL820 Administered Orally Daily to Subjects With Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Keywords: Solid tumor
Lead sponsor: Exelixis
Sponsor class: INDUSTRY
First posted: 2006-07-11
Enrollment: 30
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: The purpose of this study is to assess the safety and tolerability of the KIT inhibitor XL820 when given orally daily to adults with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* Subject has a histologically confirmed solid tumor that is metastatic or unresectable for which known effective measures do not exist or are no longer effective, and there are no known therapies to prolong survival
* Subject is at least 18 years old
* Subject has ECOG performance status ≤ 2
* Subject has a life expectancy of \> 3 months
* Subject has adequate organ and marrow function
* In the adrenocorticotropic hormone (ACTH) stimulation test, the subject has a serum cortisol level ≥ 20 ug/dL (552 nmol/L) 30-90 minutes after injection of ACTH
* Subject has given written informed consent
* Sexually active subjects (male and female) must use accepted methods of contraception during the course of the study.
* Female subjects of childbearing potential must have a negative pregnancy test at screening.

Exclusion Criteria:

* Subject has received anticancer treatment within 30 days before the first dose of XL820, or has not recovered to grade ≤ 1 from adverse events due to agents administered more than 30 days earlier
* Subject has received radiation to ≥ 25% of his/her bone marrow within 30 days of XL820 treatment
* Subject has received an investigational agent within 30 days of the first dose of XL820
* Subject has known brain metastases
* Subject has known uncontrolled intercurrent illness
* Subject is pregnant or lactating
* Subject is known to be positive for HIV
* Subject has a known allergy or hypersensitivity to any of the components of the XL820 formulation

Primary outcomes:
measure: maximum tolerated dose
measure: safety and tolerability
Secondary outcomes:
measure: plasma pharmacokinetics
measure: pharmacodynamic effects
measure: long-term safety and tolerability
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: The Cancer Institute of New Jersey
state: New Jersey
city: San Antonio
country: United States
facility: Cancer Therapy and Research Center
state: Texas
Study officials:
References:
Clinical trial NCT05423431: Retrospective Evaluation of a Commercially Available Hydrogel Spacer (BP-009)
Official title: Clinical Protocol for the Retrospective Evaluation of a Commercially Available Hydrogel Spacer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: Prostate
Prostate Cancer
Spacer
Perirectal spacer
Lead sponsor: BioProtect
Sponsor class: INDUSTRY
First posted: 2022-06-21
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Prostate Cancer

Brief summary: Dosimetry efficacy of the hydrogel spacer.

Detailed description: Single arm study for evaluation of dosimetry following use of a commercially available hydrogel spacer implanted in up to 20 males who underwent radiotherapy treatment for prostate cancer. Study utilized pre and post gel insertion CT images to determine endpoints.

Eligibility criteria: Inclusion Criteria:

* Males
* At least 18 years of age
* Undergone external beam or brachy radiation therapy with a hydrogel spacer in place

Exclusion Criteria:

* Clinical and pathological data are not available
* Invasive adenocarcinoma that is extracapsular and demonstrates posterior extension

Primary outcomes:
measure: Dosimetry Changes
timeFrame: 1 Month
Secondary outcomes:
measure: Prostate to rectum spacing
timeFrame: 1 Month
Other outcomes:
Locations:
city: Lake Success
country: United States
facility: Advanced Radiation Centers of New York ("ARC")
state: New York
Study officials:
References:
Clinical trial NCT01090531: Patients With Chronic Hepatitis B and Low Viremia Not Receiving Antiviral Therapy
Official title: A Multicenter, Prospective, Observational, Long-Term Follow-Up Study of Subjects With Chronic Hepatitis B and Low Viremia Who Do Not Receive Antiviral Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis B, Chronic
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2010-03-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic hepatitis B not receiving antiviral therapy

Brief summary: This observational long-term follow-up study will evaluate demographic, clinical, histological, biochemical, and virological parameters of patients with chronic hepatitis B and low viremia who do not require antiviral therapy according to current guidelines. Liver stiffness values as detected by FibroScan and ARFI will also be collected if available. All data will be collected at yearly intervals (minimum). Patients included in the study are followed for up to 10 years. The target sample size is \<1000.


Eligibility criteria: Inclusion Criteria:

* adult patient, age 18-79
* chronic hepatitis B
* HBV-DNA \< 100.000 IU/ml
* ALT ≤2 x ULN
* recent liver histology and/or FibroScan measurement
* willingness to sign informed consent

Exclusion Criteria:

* current or past antiviral therapy for hepatitis B
* chronic hepatitis B in immune tolerance phase (HBeAg positive, high viral load)
* co-infection with HIV, HCV
* malignant disease
* HCC or other liver tumor

Primary outcomes:
measure: Indication for Antiviral Treatment
timeFrame: 10 years
measure: Development of hepatocellular carcinoma (HCC)
timeFrame: 10 years
measure: Progression of Liver Fibrosis
timeFrame: 10 years
Secondary outcomes:
measure: HBV-DNA
timeFrame: 10 years
measure: Quantitative HBsAg
timeFrame: 10 years
measure: Serum ALT
timeFrame: 10 years
measure: Serum AFP
timeFrame: 10 years
measure: FibroTest/ActiTest
timeFrame: 10 years
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Berlin-Campus Virchow-Klinikum
city: Frankfurt
country: Germany
facility: Klinikum der J. W. Goethe-Universität
city: Hamburg
country: Germany
facility: Institut für Interdisziplinäre Medizin
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Herne
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Herne
city: Kiel
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Kiel
Study officials:
affiliation: Medizinische Klinik 1, Klinikum der J. W. Goethe-Universität Frankfurt am Main, Germany
name: Christoph Sarrazin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06070831: Respiratory Muscle Training in Acquired Brain Injury Patients.
Official title: Comparison Between Two Respiratory Muscle Training Protocols: Inspiratory Muscle Training vs Expiratory Muscle Training in Acquired Brain Injury Patients.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Respiratory Disease
Muscle Weakness
Acquired Brain Injury
Older People--Abuse of
Physical Inactivity
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Respiratory health problems are one of the main causes of morbidity and mortality in adult people with acquired brain injury (ABI). The influence of respiratory muscle training has not yet been studied in this population group. The objective of the study was to evaluate and compare the efficacy of two protocols with respiratory muscle training, inspiratory muscle training vs expiratory muscle training, to improve respiratory strength and pulmonary function in adults with CP.

Methods: The study is a controlled, randomised, double-blind trial and with allocation concealment. 26 ABI patients will be recruited and randomly distributed in the inspiratory muscle training group (IMT) and the expiratory muscle training group (EMT). Over an 8-week period an IMT or EMT protocol was followed 5 days/week, 5 series of 1-minute with 1-minute rest between them. IMT trained with a load of 50% of the maximum inspiratory pressure (MIP) and EMT with 50% of the maximum expiratory pressure (MEP). Respiratory strength and pulmonary function were evaluated.


Eligibility criteria: Inclusion Criteria:

* Belong to ASDACE.
* Sign the Informed consent.

Exclusion Criteria:

The presence of a respiratory disease in the previous month, inability to understand assessment tests or intervention or hemodynamic alterations (heart rate \> 150 beats per minute (bpm), systolic blood pressure \> 140 millimeters mercury (mmHg) or diastolic blood pressure \> 90 mmHg).

Primary outcomes:
measure: Inspiratory muscle strength
timeFrame: 8 weeks.
measure: Expiratory muscle strength
timeFrame: 8 weeks.
Secondary outcomes:
measure: Pulmonary volume.
timeFrame: 8 weeks.
measure: Pulmonary flow.
timeFrame: 8 weeks.
Other outcomes:
Locations:
Study officials:
affiliation: University of Salamanca
name: CARLOS MARTIN SANCHEZ, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02966431: Effects of a Weight Loss Intervention in College-age Women
Official title: Effects of a Weight Loss Intervention in College-age Women
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Weight Loss
Lead sponsor: Texas Christian University
Sponsor class: OTHER
First posted: 2016-11-17
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Determine the effects of an 8-week weight loss intervention.

Detailed description: The purpose of this study is three-fold: 1) Determine whether an 8-week, patient-centered, weight loss intervention can be successfully implemented in overweight, college-age females for promotion of weight loss and prevention of weight regain at 8-weeks, three months, and six months follow-up; 2) Determine the effects of the intervention on established markers of calorie restriction, energy expenditure and body composition; 3) Determine the effects of a liquid meal on physiological and subjective markers of hunger and satiety from pre- to post- 8wk intervention in the intervention group vs control group.

Eligibility criteria: Inclusion Criteria:

* Females age 18-25years
* Body Mass Index 25.0 to 29.9 kg/m2 (overweight)
* Agree to receive frequent contacts from investigators and communicate with program staff for up to 6 months
* Willing to measure blood glucose via finger prick test three to eight times per day for two weeks
* Able to give written informed consent
* Able to comply with study procedures

Exclusion Criteria:

* Unable or unwilling to give informed consent
* Travel plans that do not permit participation
* Pregnant or planning on becoming pregnant during the 6 months of participation in the study
* Weight loss or gain exceeding 5% of body weight in the past 3 months
* Current participation in a weight loss program
* Diagnosis of mental disorder or chronic disease
* History of eating disorder such as anorexia nervosa, bulimia nervosa, or binge eating disorder (unless approved by program staff)
* History of surgery or procedure that could affect swallowing or digestion
* Any person who is on a medically prescribed diet
* Any current supplement use other than a daily multivitamin
* Any current metabolic medication use other than birth control
* Any bleeding disorders or blood clotting problems
* Anyone who has donated blood or plasma in the last 20 days
* Any tobacco or illicit drug users
* Anyone who has allergies to any of the components of the liquid meal

Primary outcomes:
measure: Body weight
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Texas Christian University
state: Texas
Study officials:
References:
Clinical trial NCT04100031: Efficacy of an Ocular Bandage Contact Lens for the Treatment of Dry Eye After Cataract Surgery
Official title: Efficacy of an Ocular Bandage Contact Lens for the Treatment of Dry Eye After Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Dry Eye
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2019-09-23
Enrollment: 140
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the efficacy of an ocular bandage contact lens for the treatment of dry eye after cataract surgery


Eligibility criteria: Inclusion Criteria:

1. age-related cataract
2. dry eye disease

Exclusion Criteria:

1. a history of surgery and other ocular diseases
2. contact lens use
3. ocular therapies such as 0.05% cyclosporine A or steroids in the last 3 months. had 4.any systemic diseases such as heart diseases, diabetes and psychosis.

Primary outcomes:
measure: Change from Baseline Ocular Surface Disease Index at 1 week
timeFrame: 0 day, 1 week postoperative
measure: Change from Baseline Ocular Surface Disease Index at 1 month
timeFrame: 0 day, 1 month postoperative
measure: Change from Baseline meibography score at 1 week
timeFrame: 0 day, 1 week postoperative
measure: Change from Baseline meibography score at 1 month
timeFrame: 0 day, 1 month postoperative
measure: Change from Baseline of non-invasive keratograph tear meniscus height at 1 month
timeFrame: 0 day, 1 month postoperative
measure: Change from Baseline of non-invasive keratograph tear meniscus height at 1 week
timeFrame: 0 day, 1 week postoperative
measure: Change from Baseline noninvasive tear breakup time at 1 week
timeFrame: 0 day, 1 week postoperative
measure: Change from Baseline noninvasive tear breakup time at 1 month
timeFrame: 0 day, 1 month postoperative
measure: Change from Baseline Schirmer I test at 1 week
timeFrame: 0 day, 1 week postoperative
measure: Change from Baseline Schirmer I test at 1 month
timeFrame: 0 day, 1 month postoperative
measure: slit-lamp examination
timeFrame: 0 day
measure: Change from Baseline IL-1, IL-6, IL-12, IL-10, IL-8, TNF-α and ICAM-1 level at 1 month
timeFrame: 0 day and 1 month postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
citation: Wu X, Ma Y, Chen X, He S, Lin X, Yu X, Chen W, Luo C, Xu W. Efficacy of bandage contact lens for the management of dry eye disease after cataract surgery. Int Ophthalmol. 2021 Apr;41(4):1403-1413. doi: 10.1007/s10792-021-01692-6. Epub 2021 Jan 28.
Clinical trial NCT01058031: Neural Correlates of PTSD Prevention With Mindfulness Based Stress Reduction (MBSR) in Iraqi Veterans
Official title: Neural Correlates of PTSD Prevention With MBSR in Iraqi Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Disorders, Posttraumatic
PTSD
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Emory University
First posted: 2010-01-28
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare Mindfulness Based Stress Reduction to a supportive therapy control group.


Eligibility criteria: Inclusion Criteria:

* PTSD related to OEF/OIF service

Exclusion Criteria:

* History of brain injury

Primary outcomes:
measure: PTSD symptom level measured with the CAPS
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur
state: Georgia
Study officials:
affiliation: Atlanta VA Medical and Rehab Center, Decatur
name: Doug Bremner, MD
role: PRINCIPAL_INVESTIGATOR
References: