louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00767585: An Open Label Non-Interventional Evaluation of the Effect of Adjuvant Hormonal Treatment of Postmenopausal Women Wih Early Breast Cancer With Aromatase Inhibitors on Bone Mineral Density and Bone Fracture Rate in Daily Practice
Official title: An Open Label Non-Interventional Evaluation of the Effect of Adjuvant Hormonal Treatment of Postmenopausal Women Wih Early Breast Cancer With Aromatase Inhibitors on Bone Mineral Density and Bone Fracture Rate in Daily Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Osteoporosis
Keywords: breast cancer
aromatase inhibitors
bone mineral density
osteoporosis
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-10-07
Enrollment: 560
Sex: FEMALE
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Institute of Oncology

Brief summary: The aim of this study is to determine the effect of aromatase inhibitors therapy on bone mineral density and compare it to the effects of tamoxifen and no hormonal therapy.


Eligibility criteria: Inclusion Criteria:

* Women aged 55-65 years, diagnosed with invasive early breast cancer: - Surgery, chemo- and/or radiotherapy concluded less than 6 months ago
* Women with hormone-independent breast cancer: - Surgery, chemo- and/or radiotherapy concluded before 24-36 months or 54-66 months
* Women with hormone-dependent breast cancer:- Adjuvant therapy with tamoxifen initiated before 24-36 and 54-66 months or - Adjuvant therapy with aromatase inhibitor initiated before 24-36 and 54-66 months or - Switch from tamoxifen to aromatase inhibitor initiated before 24-36 months

Exclusion Criteria:

* Women receiving active treatment for osteoporosis
* Women with any evidence of breast cancer recurrence

Primary outcomes:
measure: To determine the effect of aromatase inhibitors therapy on bone mineral density as measured by DEXA scan and compare it to the effects of tamoxifen and no hormonal therapy.
timeFrame: once
Secondary outcomes:
measure: To determine the bone fracture rate in women on aromatase inhibitors therapy and compare it to fracture rates observed in the tamoxifen and the hormone-independent group.
timeFrame: once
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: Research Site
Study officials:
affiliation: Institute of Oncology Ljubljana
name: Simona Borstnar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03580785: Primary Failure of Eruption (PFE) : Highlighting of Clinical, Radiological and Genetic Diagnostic Criteria: Consequences on the Therapeutic Management
Official title: Primary Failure of Eruption (PFE) : Highlighting of Clinical, Radiological and Genetic Diagnostic Criteria: Consequences on the Therapeutic Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Primary Failure of Eruption
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-07-09
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single group
Primary purpose: DIAGNOSTIC

Brief summary: The primary purpose of the study is to identify clinical, radiological and genetic diagnostic criteria for Primary Failure of Eruption (PFE).

The secondary purposes are to highlight the genotype-phenotype correlations in the PTHR1 and non-PTHR1 forms and analyze the therapeutic failures.


Eligibility criteria: Inclusion criteria:

* people over 6 years old
* people with Primary Failure Eruption

Exclusion criteria:

* children under 6 years old
* endocrine pathology that may interfere with dental eruption
* rickets
* chemotherapy / radiotherapy
* bisphosphonate treatment

Primary outcomes:
measure: Number of teeth
timeFrame: at inclusion (day 1)
measure: Recording of dental caries
timeFrame: at inclusion (day 1)
measure: Recording the location of dental caries
timeFrame: at inclusion (day 1)
measure: Drugs intra uterine exposure
timeFrame: at inclusion (day 1)
measure: Nutritional deficiencies
timeFrame: at inclusion (day 1)
measure: Periodontium
timeFrame: at inclusion (day 1)
measure: Oral hygiene
timeFrame: at inclusion (day 1)
measure: Gingival inflammation
timeFrame: at inclusion (day 1)
measure: Treatment needs
timeFrame: at inclusion (day 1)
measure: Face shape
timeFrame: at inclusion (day 1)
measure: Symmetry of the face
timeFrame: at inclusion (day 1)
measure: Profile (shape)
timeFrame: at inclusion (day 1)
measure: Smile
timeFrame: at inclusion (day 1)
measure: Vertical dimension
timeFrame: at inclusion (day 1)
measure: Transversal dimension
timeFrame: at inclusion (day 1)
measure: Sagittal dimension
timeFrame: at inclusion (day 1)
measure: Chewing
timeFrame: at inclusion (day 1)
measure: Nasal breathing
timeFrame: at inclusion (day 1)
measure: Swallowing
timeFrame: at inclusion (day 1)
Secondary outcomes:
measure: Mutations causing PFE
timeFrame: at inclusion (day 1)
measure: Type of treatment performed
timeFrame: at inclusion (day 1)
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Clinique dentaire
Study officials:
References:
Clinical trial NCT01362985: Analysis of Data Collected in the European Group for Blood and Marrow Transplantation (EBMT) Registry for Off-Label Transplant Use of Plerixafor
Official title: Monitoring of Plerixafor Off-Label Use in the European Group for Blood and Bone Marrow Transplantation (EBMT) Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Leukemia
Chronic Leukemia
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Solid Tumors
Lymphoma
Plasma Cell Disorders
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
Collaborators: name: European Society for Blood and Marrow Transplantation
First posted: 2011-06-01
Enrollment: 201
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated off-label with plerixafor.

Brief summary: Genzyme will evaluate/monitor the off label transplant use of plerixafor using data in the European Group for Blood and Marrow Transplantation (EBMT) registry. Off-label use of plerixafor will be collected for data entered over a 5 year time span (i.e., data entered into the registry between the date of European Union (EU) marketing authorization \[31 July 2009\] and 31 July 2014).

The EBMT is a non-profit, scientific society representing more than 600 transplant centers mainly in Europe. The EBMT promotes all activity aiming to improve stem cell transplantation or cellular therapy, which includes registering all the activity relating to stem cell transplants. Data are entered, managed, and maintained in a central database with internet access; each EBMT center is represented in this database.

The collection by the EBMT registry of reasons for the off-label transplant use of plerixafor shall provide information of a substantial number of patients who are representative of the patient population receiving plerixafor off-label.


Eligibility criteria: Inclusion Criteria: Patients treated with plerixafor who have 1 or more of the following:

* Background disease other than lymphoma or multiple myeloma (MM)
* Are younger than 18 years of age.
* Received transplant using ex vivo plerixafor-mobilised cells (umbilical cord cell, peripheral blood (PB), bone marrow (BM) cell collection)
* Received treatment with plerixafor alone (i.e., without granulocyte colony stimulating factor (G-CSF))
* Contraindication for G-CSF
* Transplants using plerixafor-mobilised cells from allogeneic donor
* Received transplant using plerixafor-mobilised bone marrow cells
* Routes of plerixafor administration other than subcutaneous
* Patients whose cells do not mobilize poorly
* Other

Exclusion Criteria:

* Adults diagnosed with lymphoma or multiple myeloma (MM) and have been treated with plerixafor according to the European Union (EU) label.

Primary outcomes:
measure: Number of patients who received plerixafor outside of the label indication in Europe and the reason for administration
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04747756: Creating a Virtual Village for People Aging With HIV During COVID-19
Official title: A Solution to Halt Further Isolation of People Aging With HIV During the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hiv
Depression in Old Age
Isolation, Social
Aging
Lead sponsor: University of California, Riverside
Sponsor class: OTHER
Collaborators: name: University of South Florida
name: University of Southern California
name: HIV+Aging Research Project-Palm Springs
First posted: 2021-02-10
Enrollment: 80
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In a PCORI-funded project on HIV and aging engagement that was co-led by the study team, the topics of isolation and depressions were identified as priority areas of deep concern among older PLWH. The COVID-19 pandemic has enhanced the urgency to test interventions to mitigate depression and isolation among older PLWH. However, there is scant evidence on effective interventions that help mitigate depression and isolation among older PLWH. While physical distancing and stay at home orders are a necessary strategy to flatten the curve, ease pressure on the healthcare system, and protect the most vulnerable, the order further increases the isolation faced by people aging with HIV, and creates barriers to accessing medications, health services, and other resources. This project will include 6 virtual focus groups and 12 individual interviews with adults ages 50 or older in California (Palm Spring, Los Angeles) and the Tampa-Bay region, Florida to (1): further characterize issues related to depression, isolation, and basic needs of people aging with HIV during the COVID-19 pandemic (2) utilizing results from Aim 1, co-develop ideas for what to include in a virtual village, and (3) create and pilot the virtual village in a group of people aging with HIV. The overall goal of this study is to execute an innovative solution to address issues related to isolation for older PLWH which have been exacerbated during the COVID-19 pandemic.


Eligibility criteria: Inclusion Criteria:

* English or Spanish speaking adults
* Living with HIV
* residing in Palm Springs, Los Angeles, or Tampa Bay Florida
* age 50 or older

Exclusion Criteria:

* not able to read English or Spanish

Primary outcomes:
measure: Change in depression after pilot testing virtual village
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Riverside
country: United States
facility: UC Riverside
state: California
Study officials:
References:
Clinical trial NCT02463656: Growth Arrest in Focal Dermal Hypoplasia
Official title: Growth Arrest in Focal Dermal Hypoplasia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Focal Dermal Hypoplasia
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2015-06-04
Enrollment: 16
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with focal dermal hypoplasia

Brief summary: Focal dermal hypoplasia (FDH) is a rare genetic disorder of ectodermal dysplasia caused by mutation in the Porcupine Homolog (Drosophila) (PORCN) gene which results in skin, hair, limb and eye abnormalities. Short stature and underweight have been noted in the majority of these patients. Since the pituitary gland arises from ectodermal tissue, the investigators suspect that pituitary deficiencies may contribute to poor linear growth. This study will examine the nutritional, gastrointestinal and endocrine mechanisms that may account for linear growth stunting and low weight that is observed in FDH. The investigators will utilize standard clinical tools including a bone age xray, glucagon stimulation test to evaluate growth hormone status, baseline laboratory analysis of hormone and nutritional/gastrointestinal markers, food diaries, symptom diaries, and growth charts.

Detailed description: Focal dermal hypoplasia (FDH) is a rare genetic disorder of ectodermal dysplasia caused by mutation in the Porcupine Homolog (Drosophila) (PORCN) gene which results in skin, hair, limb and eye abnormalities. Short stature and underweight have been noted in the majority of these patients. Since the pituitary gland arises from ectodermal tissue, the investigators suspect that pituitary deficiencies may contribute to poor linear growth. This study will examine the nutritional, gastrointestinal and endocrine mechanisms that may account for linear growth stunting and low weight that is observed in FDH. The investigators will utilize standard clinical tools including a bone age xray, glucagon stimulation test to evaluate growth hormone status, baseline laboratory analysis of hormone and nutritional/gastrointestinal markers, food diaries, symptom diaries, and growth charts.

Eligibility criteria: Inclusion Criteria:

* patients with focal dermal hypoplasia
* between the ages of 3 and 18 years
* ability to fast overnight, and
* weight at least 9 kg

Exclusion Criteria:

* pregnant individuals,
* weight less than 9 kg

Primary outcomes:
measure: Determination of Growth Hormone Deficiency
timeFrame: 1 day
Secondary outcomes:
measure: Determination of poor growth
timeFrame: 1 day
measure: Determination of poor weight gain
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Stephanie C Hsu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00179556: Effects of Soy Isoflavones on Menopausal Hot Flashes
Official title: Daidzein-rich Isoflavone-aglycones for Menopausal Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Menopausal Symptoms
Keywords: Hot flashes
Menopausal symptoms
Soybean germ
Aglycones
Menopause
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Nichimo - Tokyo, Japan
First posted: 2005-09-16
Enrollment: 210
Sex: FEMALE
Minimum age (years): 38
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hot flashes occur in three quarters of menopausal women, and can negatively impact quality of life. Interest has arisen in isoflavones, found in rich supply in soy products, as therapy for hot flashes. The study examines the effect of a new soy supplement, as compared to a placebo, in menopausal women on hot flash symptoms.

Detailed description: Hot flashes occur in 75% of menopausal women and impact quality of life. Interest has arisen in isoflavones, found in rich supply in soy products, as therapy for hot flashes. The effect of a daidzein-rich isoflavone-aglycone supplement from soy germ fermentation with Koji fungus, on the severity and frequency of hot flashes in postmenopausal women is being examined in a randomized, placebo controlled, double-blinded clinical trial. The study is a 13 week trial in which subjects record their hot flash frequency and severity in a diary. Subjects are given 40 mg or 60 mg of isoflavones (or placebo) once a day. This isoflavone-aglycone extract (Agly-Max TM, Nichimo, Shinagawa, Tokyo, Japan) is a product prepared from soybean germ fermentation with Koji fungus (Aspergliius awamori) producing ß-glycosidase efficiency, followed by ethanol and water extraction and purification by using a proprietary extraction procedure. The product is rich in daidzein (70% daidzein, 10% genistein, and 20% glycitein).

Eligibility criteria: Inclusion Criteria:

No menstrual period for at least six months, Hot flashes at least four t imes per day, Ages 38-65

Exclusion Criteria:

Pregnant, BMI\>45, History of breast cancer or other estrogen dependent tumors, Abnormal uterine bleeding, Heart, renal, or liver disease, Diabetes, Women taking hormone replacement therapy or serotonin reuptake inhibitors, Women taking any dietary supplements for the treatment of hot flashes (ex. soy supplements, vitamin E, flaxseed, red clover extract) within the past 30 days

Primary outcomes:
measure: Hot flash frequency and severity
Secondary outcomes:
measure: Menopausal quality of life
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Hope Ricciotti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Deaconess Medical Center
name: George Blackburn, MD, PhD
role: STUDY_CHAIR
affiliation: Beth Israel Deaconess Medical Center
name: Lalita Khaodhiar, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05646056: A Noninterventional, Single-Center Feasibility Study to Evaluate Measures of Heart Failure Risk
Official title: A Noninterventional, Single-Center Feasibility Study to Evaluate Longitudinal Measures of Heart Failure Risk Using the Pyxida System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Cardiomyopathy, Hypertrophic
Left Ventricular Hypertrophy
Lead sponsor: Prolaio
Sponsor class: INDUSTRY
First posted: 2022-12-12
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Single-center study of asymptomatic healthy subjects and subjects with HF risk factors and no more than mild to moderate symptoms

Brief summary: This is a non-invasive/observational study in healthy and mild HF subjects utilizing clinical and ambulatory measurements to improve detection, monitoring, and management of HF risks.


Eligibility criteria: Key Inclusion Criteria:

* Cohort 2: Confirmed medical history of LVH based on American College of Cardiology (ACC)/American Heart Association (AHA) guidelines and NYHA Class I at screening
* Cohort 3: Confirmed medical history of HF consistent with current ACC/AHA guidelines and NYHA Class I at screening
* Cohort 4: Confirmed medical history of HCM consistent with ACC/AHA guidelines and NYHA Class I or II at screening

Key Exclusion Criteria:

* Active neurological disorder, such as uncontrolled seizure disorder.
* Current diagnosis of cancer or other known acute chronic infection, such as hepatitis B or hepatitis C, by medical history or an active infection requiring interventional therapy at screening.
* Shortness of breath, fatigue, heart palpitations, pain, or other limitations of physical activity

Primary outcomes:
measure: To evaluate the ability of the Pyxida System to collect measurements of heart failure (HF) risk
timeFrame: 14 days
Secondary outcomes:
measure: To evaluate subject compliance and experience using the Pyxida System
timeFrame: 14 days
Other outcomes:
measure: To evaluate the relationship between in-clinic and ambulatory measures using the Pyxida System
timeFrame: 14 days
Locations:
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
Study officials:
affiliation: Jacksonville Center For Clinical Research
name: Michael Koren, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01890356: Maintenance Transcranial Electrical Stimulation for Depression
Official title: A Study of Transcranial Electrical Stimulation (TES) as a Maintenance Treatment for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Bipolar Disorder
Keywords: Depression
Treatment
Transcranial electrical stimulation
Maintenance
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
First posted: 2013-07-01
Enrollment: 25
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: Transcranial electrical stimulation (TES) techniques offer a novel treatment approach for depression and have shown promising efficacy. However, there is no published data to date on their effectiveness as a maintenance treatment. This study will investigate ways of using TES as a maintenance treatment to prevent relapse in depression.


Eligibility criteria: Inclusion Criteria:

* All participants will be ≥ 18 years old.
* Participants must have experienced a significant clinical response, defined as ≥ 50% decrease from baseline scores on the Montgomery Asberg Depression Rating Scale (MADRS).

Exclusion Criteria:

* Inadequate response to acute trial of TES.
* Suicidality.
* Clinically defined neurological disorder or insult.
* Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites.
* Pregnancy (women of childbearing age will be asked to undergo a urine pregnancy test prior to starting the study).
* Concurrent long acting benzodiazepines, ritalin or dexamphetamine medication.
* Treatment for depression is changed during months 3-9 of the trial.

Primary outcomes:
measure: Montgomery Asberg Depression Rating Scale for Depression (MADRS)
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Randwick, Sydney
country: Australia
facility: Black Dog Institute / University of New South Wales
state: New South Wales
Study officials:
affiliation: University of New South Wales
name: Colleen Loo, MBBS
role: PRINCIPAL_INVESTIGATOR
References: