louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00900341: Studying Tumor Tissue Samples From Patients With Soft Tissue Sarcoma
Official title: LABORATORY STUDIES OF SOFT TISSUE SARCOMAS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoma
Keywords: adult soft tissue sarcoma
childhood soft tissue sarcoma
Lead sponsor: University of Arizona
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing surgical treatment for soft tissue sarcomas removal or core needle biopsy for medically indicated diagnostic or therapeutic purposes.

Brief summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at tumor tissue samples from patients with soft tissue sarcoma.

Detailed description: OBJECTIVES:

* To develop a pilot program for the collection, archiving, and experimental analyses of soft tissue sarcomas (STS).
* To obtain STS tumors from cancer patients undergoing tumor removal or core needle biopsies.
* To evaluate cellular and molecular factors involved in STS oncogenesis by studying samples derived from human tumor specimens.
* To develop an accompanying bioinformatics database of the demographics of STS patients from which tumor specimens are derived for experimental study.

OUTLINE: Tumor tissue samples are analyzed for gene and protein expression by cDNA microarray analysis, RT-PCR, immunohistochemistry, in vitro transformation assays, RNA interference, and Western blot or immunoprecipitation.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Meets one of the following criteria:

  * Patients with soft tissue sarcoma (STS) undergoing evaluation, treatment, and/or follow-up at the Arizona Cancer Center or University Medical Center
  * Patients undergoing surgical treatment for STS removal or core needle biopsy for medically indicated diagnostic or therapeutic purposes

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Identification of molecular targets that would improve the diagnosis, prognosis, and/or treatment of STS
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Cancer Center at University of Arizona Health Sciences Center
state: Arizona
Study officials:
affiliation: University of Arizona
name: Lee D. Cranmer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01686841: A Pilot Clinical Trial Investigating the Effect of Cutaneous Cooling on Sebum Production
Official title: PILOT STUDY OF NON-INVASIVE FAT LAYER REDUCTION IN THE FLANKS OF ASIAN PATIENTS WITH THE COOLCURVE+ APPLICATOR
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Fat Disorder
Keywords: Lipolysis
Cryolipolysis
Fat Reduction
Lead sponsor: Zeltiq Aesthetics
Sponsor class: INDUSTRY
First posted: 2012-09-18
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To evaluate the safety and feasibility of reducing human sebum production using the ZELTIQ System.


Eligibility criteria: Inclusion criteria

1. Male subjects \>18 years of age and \<25 years of age.
2. Subject has an average sebum output on their upper back of at least 20, as measured by the sebumeter
3. Subject has Fitzpatrick Skin Phototypes I-III (see Appendix A)
4. Willingness to participate in the study
5. Willingness to receive EXPERIMENTAL treatment
6. Informed consent agreement signed by the subject
7. Willingness to follow the treatment schedule and post treatment care requirements
8. Willingness to not use topical or systemic retinoids or antibiotics during the course of the treatment

Exclusion criteria

1. Subject has a history of isotretinoin use
2. Subject has an infection or other dermatologic condition (aside from acne) in the area to be treated
3. Subject has known cold sensitivity disorders including Raynaud's phenomena, cold urticaria, cryoglobulinemia, and cold induced hemoglobinuria
4. Presence of suntan in the area to be treated
5. Subject is immunosuppressed
6. Subject is unable to comply with treatment, home care or follow-up visits
7. Subject has a history of vitiligo
8. Subject has a history of keloid formation
9. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.
10. Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

Primary outcomes:
measure: Feasibility: Reduction of Sebum Production
timeFrame: 12 weeks post final treatment
measure: Safety: UADE
timeFrame: 12 weeks post final treatment
Secondary outcomes:
measure: Safety: AE's
timeFrame: 12 weeks post final treatment
measure: Feasibility: Reduction of Sebum Production
timeFrame: 12 weeks post final treatment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: MGH
name: Rox Anderson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03408041: Reported Time Between Onset and Diagnosis of Alzheimer's Disease: Correlation With Objective Parameters
Official title: Reported Time Between Onset and Diagnosis of Alzheimer's Disease: Correlation With Objective Parameters
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer Disease
Keywords: Alzheimer Disease
Objective parameters
Scheltens index
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2018-01-23
Enrollment: 129
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Alzheimer Disease patients admitted in the 'Memory Clinic' of the CHU Brugmann Hospital between 01-01-2010 and 31-01-2013. Diagnose according to the Dubois criteria

Brief summary: The early diagnosis of Alzheimer's disease is essential to enable patients to have access to the available treatments. However, there is a delay between the diagnosis and the onset of symptoms, which can range from 1 year to more than 5 years. In clinical practice, the hippocampal volume, measured by the Scheltens index, is currently used as a marker of the progression of the disease.

The purpose of this study is to determine whether the patient's sex, age and ethnicity can influence the delay in the expression of cognitive troubles reported by the family at the first medical consultation, as well as to determine if there is a correlation between the delay reported by the family and the Scheltens index.


Eligibility criteria: Inclusion Criteria:

Alzheimer Disease patients admitted in the 'Memory Clinic' of the CHU Brugmann Hospital between 01-01-2010 and 31-01-2013. Diagnose according to the Dubois criteria

Exclusion Criteria:

None

Primary outcomes:
measure: Age
timeFrame: Between 01-01-2010 and 31-01-2013
measure: Sex
timeFrame: Between 01-01-2010 and 31-01-2013
measure: Ethnic origin
timeFrame: Between 01-01-2010 and 31-01-2013
measure: Symptoms-diagnose time interval
timeFrame: Between 01-01-2010 and 31-01-2013
measure: Scheltens scale
timeFrame: Between 01-01-2010 and 31-01-2013
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Florence Benoit, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02247141: A Multi-centre Open Study to Assess the Safety and Efficacy of Subgam®
Official title: A Multi-centre Open Study to Assess the Safety and Efficacy of Subgam® Given Via the Subcutaneous Route in Primary Antibody Deficient Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Antibody Deficiency
Lead sponsor: Bio Products Laboratory
Sponsor class: OTHER
First posted: 2014-09-23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The primary objective was to determine the efficacy of Human Normal Immunoglobulin (Subgam®) given subcutaneously by weekly infusion to patients with primary antibody deficiency.

The secondary objective was to determine the safety of Subgam® given subcutaneously by weekly infusion to patients with primary antibody deficiency.


Eligibility criteria: Inclusion Criteria:

* The main criteria for inclusion in the study were as follows:

  * A diagnosis of primary antibody deficiency;
  * No lower or upper age limit (any age was eligible);
  * With stable disease and receiving immunoglobulin (IVIG or SCIG) therapy for at least six months prior to starting the study;
  * Written informed consent (patient/parent/guardian).

Exclusion Criteria:

-

Primary outcomes:
measure: Proportion of trough levels at each time point where serum IgG was more than equal to 4 g/L
timeFrame: Before each infusion in the first 6 months of the study (approximately 30 infusions)
Secondary outcomes:
Other outcomes:
Locations:
city: Papworth Everard
country: United Kingdom
facility: Papworth Hospital
state: Cambridgeshire
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
state: Lancashire
city: Dudley
country: United Kingdom
facility: Guest Hospital
state: West Midlands
city: Birmingham
country: United Kingdom
facility: Birmingham Children's Hospital
city: Cardiff
country: United Kingdom
facility: University Hospital of Wales
city: Leeds
country: United Kingdom
facility: St James' University Hospital
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary
city: London
country: United Kingdom
facility: Great Ormond Street Hospital
city: London
country: United Kingdom
facility: St Bartholomew's Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Salford
country: United Kingdom
facility: Hope Hospital
city: Sheffield
country: United Kingdom
facility: Northern General Hospital
city: Southampton
country: United Kingdom
facility: Southampton General Hospital
city: Surrey
country: United Kingdom
facility: St Helier Hospital, Carshalton
Study officials:
References:
citation: Dash C, Gascoigne E, Gillanders K, Gooi H. Experience with Subgam, a Subcutaneously Administered Human Normal Immunoglobulin (ClinicalTrials.gov--NCT02247141). PLoS One. 2015 Jul 29;10(7):e0131565. doi: 10.1371/journal.pone.0131565. eCollection 2015.
Clinical trial NCT00466141: Weight Maintenance Study for 2007 Shape UP RI Participants
Official title: Evaluation of the 2007 Shape Up RI Campaign: Study 3 Maintenance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Weight Loss
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2007-04-27
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This study will focus on maintenance of weight loss achieved in the 2007 Shape-Up Rhode Island(SURI)program. We plan to recruit 180 individuals who participated in SURI and lost at least 10 pounds to take part in a 4-month weight loss maintenance program when the SURI ends. Participants will be randomly assigned to one of three groups: Education, Increased Exercise, or Daily Self-Weighing.


Eligibility criteria: Inclusion Criteria:

1. Are 18 years or older
2. Lost 10 or more pounds during the 2007 Shape Up RI program
3. Want to learn skills to maintain your weight loss
4. Can come to the Weight Control and Diabetes Research Center located at 196 Richmond Street in the "The Jewelry District" of Providence for a baseline assessment visit in mid-May/mid-June and final assessment visit in mid-October.
5. Agree to be randomly assigned (which means you cannot choose) to one of the three weight loss maintenance interventions: General Education, Increased Physical Activity, or Self-Regulation
6. Available to take part in six 30-minute conference calls on either a Monday, Tuesday or Thursday starting at noon or 12:30pm. You will be given a toll-free call-in number so you can call from any location. The calls would be weekly for 4 weeks starting in June, and then there would be one call in mid-August and one in mid-September.

Exclusion Criteria:

1. Not 18 or more years old.
2. Did not participate in the 2007 Shape UP RI program
3. Participated in 2007 Shape Up RI but lost less than 10 pounds in the program.
4. Currently or plan to become pregnant in the next 4 months.
5. Currently participating in another weight loss or exercise study.
6. Not available to take part in six 30-minute conference calls on either a Monday, Tuesday or Thursday starting at noon or 12:30pm. The calls would be weekly for 4 weeks starting in June, and then there would be one call in mid-August and one in mid-September.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Weight Control and Diabetes Research Center/The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: Lifespan/ The Miriam Hospital
name: Rena R Wing, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00488241: Multicenter Clinical Study to Examine the Efficacy and Safety of Zarzenda in Patients With Hand Eczema
Official title: A Multicenter, Open Uncontrolled Clinical Study to Examine the Efficacy and Safety of Zarzenda in the Management of Hand Eczema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hand Eczema
Keywords: Eczema
Medical device
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-06-20
Enrollment: 40
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: To show efficacy of Zarzenda in the treatment of hand eczema

Detailed description: The objective of the study is to demonstrate efficacy and safety of Zarzenda (a medical device) in the management of hand eczema.

Eligibility criteria: Inclusion Criteria:

* Mild to moderate hand eczema for at least 3 months
* At least 4 weeks have passed since use of systemic treatment for eczema
* At least 4 weeks have passed since any vaccination
* At least 1 week has passed since last topic treatment on hands with corticosteroids
* Agree to use adequate contraceptive method if of childbearing potential
* Willingness to avoid excessive exposure to sunlight and avoid skin irritants

Exclusion Criteria:

* Pregnancy, breast feeding
* Severe excoriations on the hands
* Need for systemic treatment for atopic dermatitis
* Known sensitivity to Zarzenda and/or to extract of nut butyrospermum parkii (shea)
* Known immune deficiency
* Concomitant infection on hands

Primary outcomes:
measure: Hand eczema severity index (HECSI)at the end of study
timeFrame: End of study compared to baseline
Secondary outcomes:
measure: Investigator's Global Assessment
timeFrame: End of study compared to baseline
measure: Patients assessment of itch
timeFrame: End of study compared to baseline
measure: Hand surface area
timeFrame: End of study compared to baseline
measure: Clinical signs of hand eczema
timeFrame: End of study compared to baseline
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Intendis GmbH
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02761941: Excessive Warfarin Anticoagulation - Causes and Consequences
Official title: Excessive Warfarin Anticoagulation - Causes and Consequences
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anticoagulation
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2016-05-04
Enrollment: 25000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with VKA for atrial fibrillation in the Southwest Finland hospital district area with INR value over 9.

Brief summary: The aim of this study is to investigate the clinical significance of high INR (International Normalized Ratio) values (\>9) in VKA (vitamin K antagonist) treated patients with atrial fibrillation. The clinical characteristics of these patients will be studied as well as the clinical presentation. Factors influencing on high INR values will be recorded and the aim is to seek out patients who have elevated risk of bleeding complications.

Detailed description: This is a retrospective study setting. Source data will be collected by reviewing medical records and through computer searches. The basic study population will be identified from laboratory INR test results taken between 2003-2015.

Identifying patients with INR values over 9 will be selected for further analysis, concerning the clinical presentation, patient characteristics, 90 day survival and adverse event rates. The focus is in identifying patient characteristics and factors influencing the risk of high INR value. Also we will analyse the effects of medically reversing the high INR values on stroke and other adverse event rates. The results will be collected manually using an electronic case report form, and analysed statistically using SPSS/SAS statistics tool.

Eligibility criteria: Inclusion Criteria:

* VKA treatment, age \> 18, INR \>9,

Exclusion Criteria:

* age \< 18

Primary outcomes:
measure: All cause mortality
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital
name: Juhani Airaksinen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01346241: Improving Access To Services to Community Based Outpatient Clinics (CBOC's)
Official title: Improving Access To Services With An Intensive Two-Day Treatment For Panic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Panic Disorder
Keywords: Panic
Anxiety
Lead sponsor: Michael E. DeBakey VA Medical Center
Sponsor class: FED
First posted: 2011-05-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the feasibility of delivering IPCT in three rural VA community based outpatient clinics (CBOCs).

Detailed description: We will first need to develop a more thorough understanding of the potential barriers associated with implementing this novel form of treatment in these settings by conducting focus groups at each facility. This information will then be used to modify the treatment, which will then be piloted with Veterans enrolled in these clinics who have panic disorder.

Eligibility criteria: Inclusion Criteria:

* OEF/OIF/OND Veteran with current diagnosis of panic disorder with or without agoraphobia (presence of other anxiety disorders is acceptable)

Exclusion Criteria:

* Current substance dependence
* psychosis
* symptomatic bipolar disorder
* severe depression with suicidal intent or plan

Primary outcomes:
measure: Intensive Panic Control Treatment (IPCT)
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center and CBOC's (Lufkin, Texas City, and Conroe)
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center
name: Ellen Teng, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03902041: The Prospective Randomized Controlled Study of Eltrombopag on Hematopoietic Reconstruction After Allogeneic HSCT
Official title: The Prospective Randomized Controlled Clinical Study of Eltrombopag on Hematopoietic Reconstruction After Allogeneic Hematopoietic Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Allogeneic Hematopoietic Stem Cell Transplantation
Eltrombopag
Lead sponsor: Shandong Provincial Hospital
Sponsor class: OTHER_GOV
First posted: 2019-04-03
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients after allogeneic hematopoietic stem cell transplantation

Brief summary: This study evaluates the addition of Eltrombopag after Hematopoietic stem cell transplantation (HSCT) to improve the engraftment of hematopoietic stem cell. Half of the participants will receive Eltrombopag,while the other will not receive the Eltrombopag.

Detailed description: With the progress of transplantation technology，allogeneic hematopoietic stem cell transplantation is becoming an important treatment for hematological diseases and the long-term survival of patients is gradually improved. However, thrombocytopenia after transplantation has always been an important complication. Studies have shown that about 20% patients had different degrees of thrombocytopenia. Eltrombopag could promote hematopoietic stem cell proliferation and differentiation in vitro studies. It has also been widely used in the treatment of immune thrombocytopenia (ITP) and aplastic anemia(AA) and increased platelet levels in such diseases. Eltrombopag is also used to treat poor platelet engraftment after transplantation and the effective rate is about 60%-80%. Therefore, the application of Eltrombopag at early time after transplantation might promote platelet engraftment and reduce platelet transfusions.

Eligibility criteria: Inclusion Criteria:

1. Patients with definite diagnosis of hematological diseases, more than 30 kg, age18-60 years, gender and race are not limited;
2. Acceptance of allogeneic hematopoietic stem cell transplantation;
3. Voluntary acceptance of the study

Exclusion Criteria:

1. Patients with severe organ dysfunction or disease；
2. Patients who cannot tolerate oral Eltrombopag therapy;
3. Patients who refuse all-HSCT and Eltrombopag treatment;
4. Patients that investigator believed not suitable for enrollment.

Primary outcomes:
measure: The engraftment of platelet
timeFrame: 3 years
measure: The levels of platelet
timeFrame: 3 years
Secondary outcomes:
measure: The number of platelet transfusions
timeFrame: 3 years
Other outcomes:
measure: The engraftment of white blood cell
timeFrame: 3 years
measure: OS
timeFrame: 3 years
Locations:
city: Jinan
country: China
facility: Heamtology Department, Provincial Hospital Affiliated to Shandong University
state: Shandong
Study officials:
affiliation: Shandong Provincial Hospital
name: Xin Wang
role: PRINCIPAL_INVESTIGATOR
References: