louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00365456: Sequential Treatment of Postmenopausal Women With Primary Osteoporosis (FP-001-IM)
Official title: An Open Label, International, Multi Centre, Parallel Group, Phase III b, Randomised Trial, Investigating Lumbar Spine Bone Mineral Density (BMD) Changes in Postmenopausal Women With Primary Osteoporosis Initially Treated With 12 Months of Full Length Parathyroid Hormone (PTH 1-84) Followed by 12 Months of Treatment With Risedronate Followed by Either 12 Months Treatment With PTH (1-84) or Risedronate.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Keywords: Lumbar Spine Bone Mineral Density (BMD)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2006-08-17
Enrollment: 407
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective is to show superior efficacy of PTH (1-84) over risedronate in treating osteoporotic women for 12 months after having previously been treated with PTH (1-84) for 12 months followed by 12 months treatment with risedronate.


Eligibility criteria: Inclusion Criteria:

Women above the age of 50 years with the diagnosis of postmenopausal primary osteoporosis may be enrolled in the trial if the following inclusion/exclusion criteria apply.

All inclusion criteria must be answered "yes" for a subject to be enrolled in the trial.

1. Has the subject given informed consent according to local requirements before any trial related activities? (A trial related activity is any procedure that would not have been performed during the routine management of the subject).
2. Is the subject above 50 years old?
3. Is the subject postmenopausal (more than 5 years) - in the judgement of the investigator?
4. Does the subject have primary osteoporosis with a lumbar spine T score \< -3.0 SD (at lumbar spine L1-L4, with a minimum of two evaluable vertebrae)?
5. Does the subject have a life expectancy of \>3 years?
6. Is the subject able to self-inject PTH (1-84), (or to have PTH (1-84) injection by a helper)?

Primary outcomes:
measure: Change in Lumbar Spine BMD From Start of Trial Period III Until End of Trial Period III.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Roskilde
country: Denmark
Study officials:
affiliation: Headquaters
name: Nycomed Clinical Trial Operations
role: STUDY_CHAIR
References:
Clinical trial NCT02162056: Coronary and Structural Interventions Ulm - Bioresorbable Vascular Scaffold
Official title: Coronary and Structural Interventions Ulm - Bioresorbable Vascular Scaffold
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Ischemic Heart Disease
Stable Angina
Unstable Angina
Acute Myocardial Infarction
Lead sponsor: University of Ulm
Sponsor class: OTHER
First posted: 2014-06-12
Enrollment: 326
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 evaluate the safety, performance and efficacy of the bioresorbable vascular scaffold (BVS) system in patients with coronary artery disease

Detailed description: Patients with coronary artery disease receive bioabsorbable vascular scaffolds. Patients are clinically followed during a period of 10 years.

Eligibility criteria: Inclusion Criteria:

* coronary artery disease
* implantation of at least one bioresorbable vascular scaffold

Exclusion Criteria:

* no written informed consent

Primary outcomes:
measure: Major Adverse Cardiac Events
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ulm
country: Germany
facility: University of Ulm
Study officials:
affiliation: University of Ulm, Ulm, Germany
name: Jochen Wöhrle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Reichart C, Wohrle J, Markovic S, Rottbauer W, Seeger J. Clinical results of bioresorbable drug-eluting scaffolds in short and long coronary artery lesions using the PSP technique. BMC Cardiovasc Disord. 2019 Jan 18;19(1):22. doi: 10.1186/s12872-018-0994-y.
citation: Markovic S, Kugler C, Rottbauer W, Wohrle J. Long-term clinical results of bioresorbable absorb scaffolds using the PSP-technique in patients with and without diabetes. J Interv Cardiol. 2017 Aug;30(4):325-330. doi: 10.1111/joic.12392. Epub 2017 Jun 1.
citation: Markovic S, Dragomir S, Walcher D, Bernhardt P, Imhof A, Rottbauer W, Wohrle J. Clinical results of single and multiple bioresorbable drug-eluting scaffolds for treatment of de-novo coronary artery disease. Coron Artery Dis. 2016 Nov;27(7):561-5. doi: 10.1097/MCA.0000000000000392.
Clinical trial NCT05578456: Effect of Prednisone and Aspirin on IVF-ET Outcome Among Patients With Thyroid Autoimmunity
Official title: Effect of Prednisone and Aspirin on Pregnancy Outcomes After Embryo Transfer Among Patients With Thyroid Autoimmunity: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Thyroiditis, Autoimmune
Infertility
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: Ningbo Women & Children's Hospital
name: Jinhua People's Hospital
name: Jiaxing Maternity and Child Health Care Hospital
First posted: 2022-10-13
Enrollment: 540
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial was a 1:1 (active:placebo) randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of prednisone and aspirin for the in vitro fertilization and embryo transfer outcome among patients with thyroid autoimmunity.


Eligibility criteria: Inclusion Criteria:

1. TPOAb\>34IU/ml and/or TgAb\>115IU/ml
2. ≥5 follicles with average diameter lager than 14 mm at trigger day
3. ≥5 oocytes retrieved
4. for frozen embryo transfer, at least 2 cleavage stage embryos, among which at least one morphologically good quality embryo, or at least 1 morphologically good quality embryo in blastocyst stage
5. age: 20-38 years old
6. Patients whose written ICF approved by the EC has been obtained, after having been duly informed of the nature of the study and voluntarily accepted to participate after being fully aware of the potential risks, benefits and any discomfort involved.

meet item 1, 5, 6, and one of item 2, 3, 4.

Exclusion Criteria:

* hyperthyroidism
* intrauterine adhesion
* with endometrium thickness less than 6mm
* uterine malformation
* PGT
* with other autoimmune diseases need glucocorticoid or aspirin treatment
* gluacoma
* gastric ulcer

Primary outcomes:
measure: clinical pregnancy rate
timeFrame: 3-5 weeks after embryo transfer
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Zhejiang University
name: Min Jin, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04430556: Brain Hippocampal Volume Relationship With Anxious Symptoms in Major Depressive Patients
Official title: Study on the Brain Hippocampal Volume, Cortisol and C-reactive Protein Levels Relationship With Anxious Symptoms in Major Depressive Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Disorder
Anxiety Disorders
Keywords: major depressive disorder
hippocampal volume
cortisol
c-reactive protein
brain metabolites
MRI
anxiety
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
Collaborators: name: Instituto de Información e Investigación en Salud Mental A. C.
First posted: 2020-06-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this transversal study is to determine if there is a difference in the volume of the hippocampus with the degree of anxiety.


Eligibility criteria: Inclusion Criteria:

* First-time patients, without prior antidepressant treatment that meet the diagnostic criteria of DSM 5 for major depressive disorder.
* Patients who meet the current major depressive disorder criteria in the MINI interview.
* Patients who signed the informed consent for the investigation.

Exclusion Criteria:

* Patients presenting insufficient data in the MINI interview for current major depression.
* Patients diagnosed with intellectual development disorder, by clinic.
* Patients with diagnosis of the schizophrenic spectrum, bipolar disorder, autism spectrum disorder, post-traumatic stress disorder and obsessive-compulsive disorder by clinic and / or by the MINI interview.
* Patients with contraindications for MRI.
* Patients with serious or unstable medical problems.
* Patients undergoing some legal procedure.
* Patients with difficulties in understanding the interview or completing the assessment instruments.

Primary outcomes:
measure: Response on Hamilton Anxiety Rating Scale
timeFrame: Change from baseline to week 8
Secondary outcomes:
measure: Response on Clinical Global Impression-Improvement
timeFrame: Change from baseline to week 8
measure: Response on Hamilton Depression Rating Scale
timeFrame: Change from baseline to week 8
measure: Response on Montgomery-Asberg Scale for Depression
timeFrame: Change from baseline to week 8
measure: Response on Columbia Scale for Suicidality
timeFrame: Change from baseline to week 8
measure: Response on State-Trait Depression Inventory
timeFrame: Change from baseline to week 8
measure: Response on Beck Anxiety Inventory
timeFrame: Change from baseline to week 8
measure: Response on EQ-5D
timeFrame: Change from baseline to week 8
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose E. Gonzalez
state: Nuevo Leon
Study officials:
affiliation: Hospital Universitario Dr. Jose E. Gonzalez
name: Jose A Ontiveros Sanchez de la Barquera, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01395056: Study of Chemotherapy With Adoptive Cellular Therapy With DC-CIK Cells in Triple Negative Breast Cancer Patients
Official title: Study of Chemotherapy Combined With Adoptive Cellular Therapy With Dendritic and Cytokine-induced Killer Cells in Triple Negative Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Neoplasm Metastasis
Keywords: breast neoplasm
Neoplasm Metastasis
Drug Therapy
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2011-07-15
Enrollment: 23
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: female patients with metastatic breast cancer

Brief summary: To access the effectiveness of cyclophosphamide combined thiotepa and carboplatin chemotherapy combined with adoptive cellular therapy with dendritic and cytokine-induced killer cells in triple negative metastatic breast cancer patients

Detailed description: 1. Metastatic breast cancer patients should be definitively diagnosis based on histopathology, with ER-negative and PR-negative, FISH testing for her-2-negative
2. All the patients enrolled will be given standard cyclophosphamide combined thiotepa and carboplatin chemotherapy and cellular therapy.Cellular therapy consisting of one cycle of chemotherapy followed by an apheresis and ex vivo cultures to generate DC and CIK, followed by low-dose Oral Cyclophosphamide .
3. The response is assessed using Response Evaluation Criteria in Solid Tumor Group (RECIST) guidelines.
4. Estimate time to progression, survival rates and clinical benefit response on patients.
5. Find biomarkers associated with drug response.

Eligibility criteria: Inclusion Criteria:

* Failure to anthracycline and/or taxol chemotherapy;
* metastatic tumor is histologically confirmed by immunohistochemical staining to be ER-negative and PR-negative. FISH testing for her-2-negative;
* Metastatic tumor can not be removed through surgery procedure;
* An Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
* Normal cardiac, hepatic, renal and bone marrow functions;
* Life expectancy ≥3 months.

Exclusion Criteria:

* Central nervous system metastases;
* Serious or uncontrolled concurrent medical illness;
* History of other malignancies;
* Having been enrolled in some other clinal trials within a month;

Primary outcomes:
measure: progression-free survival
timeFrame: six months to two year
Secondary outcomes:
measure: clinical benefit response and overall survival
timeFrame: six months to two year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Jing Yu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05555056: Enhancing the Effectiveness of Cognitive Behavioral Therapy Using Non-invasive Brain Stimulation
Official title: Enhancing the Effectiveness of Cognitive Behavioral Therapy Using Non-invasive Brain Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Anxiety
Stress Disorders, Post-Traumatic
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Winnipeg Foundation
First posted: 2022-09-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Thirty participants among those who are enrolled in the parent clinical trial will be recruited. Participants will receive 5-week CBTm treatment and a battery of psychological assessment as part of the parent clinical trial. Individuals enrolled in the current study will receive daily HD-tDCS during the period of CBTm treatment (5-week). Half of the individuals will receive real stimulation and the other half will receive sham stimulation. Participants will be scanned with MRI before and after the 5-week treatment. EEG data will be collected before (10 minutes), during (20 minutes) and after (20 minutes) each HD-tDCS session .
Primary purpose: TREATMENT

Brief summary: The purpose of the proposed study is to examine if a repeated treatment of High Definition Transcranial Direct Current Stimulation (HD-tDCS) can increase the functional connectivity between the left ventrolateral prefrontal cortex and posterior cingulate, which may further enhance the effects of cognitive behavioral therapy with mindfulness classes.


Eligibility criteria: Inclusion Criteria:

* all patients who have agreed to participate in virtual mental health treatment at health care sites throughout Manitoba. Eligible participants will be those enrolled in a range of mental health programs, including CBT, DBT, virtual hospital wards, and group-based treatment (e.g., CBTm, Managing Difficult Emotions, etc). The target population will also include providers and decision makers offering virtual mental health programs. Individuals must meet the following criteria to be eligible to participate in the study: 1) must be a patient/client enrolled in a virtual mental health program OR a provider/decision maker offering a virtual mental health program, and 2) located within Manitoba

Exclusion Criteria:

* contraindication for MRI (e.g., metallic implants and claustrophobia)

Primary outcomes:
measure: Functional Connectivity
timeFrame: Change from Baseline Functional Connectivity after 5 month HD-tDCS/CBTm treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
References:
Clinical trial NCT03688256: Obalon US Commercial Registry
Official title: Obalon Balloon System: Real-World Evidence Commercial Site Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Surgical Specialists of Louisiana
Sponsor class: OTHER
Collaborators: name: Obalon Therapeutics, Inc.
First posted: 2018-09-28
Enrollment: 1343
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Obalon Commercial Patients

Brief summary: Retrospective study of the data reported in the Obalon US Commercial Registry

Detailed description: Retrospective analyses of the safety and effectiveness data in the Obalon US Commercial Registry reported by participating clinics through August 28, 2018 from patients who started the Obalon therapy from January to December 2017 to represent the first year of commercialization. All patients included in the safety and efficacy analyses must have data through balloon removal and a starting BMI greater than or equal to 25, the definition of overweight and obese patients.

Eligibility criteria: Inclusion Criteria:

* Started Obalon Balloon Therapy between Jan.-Dec. 2017
* Weight loss data through balloon removal
* BMI \>25kg/m2

Primary outcomes:
measure: Primary Safety Outcome - Serious Adverse Events
timeFrame: 6 months
measure: Primary Effectiveness Outcome - Weight Loss Metrics
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05431556: Virtual Mind-Body Exercises for People Having Pancreatic Surgery
Official title: Pilot Study of Virtual Mind-Body Exercises for Patients Undergoing Pancreatic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreas Disease
Keywords: Exercises
22-070
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2022-06-24
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to find out if it is practical to provide 2 interventions, VMB exercise classes and EUC (pre-recorded self-care videos), during the perioperative period (before and after surgery) to improve health-related outcomes and quality of life for people undergoing a pancreatectomy.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years or older
* Any pancreas disease (benign, pre-malignant, or malignant) and will be undergoing pancreatectomy
* Has at least one week to participate in the study prior to the anticipated surgery date
* Eastern Cooperative Oncology Group (ECOG) Performance status 0 or 1
* English-speaking only

Exclusion Criteria:

* Unable to give informed consent due to cognitive impairment or impaired decisionmaking capacity
* Cognitive impairment precluding response to study assessments
* Received neoadjuvant or any chemoradiation in the past 60 days
* Unwilling to accept random assignment
* Unwilling to commit to the 12-week study time period
* Unlikely to be compliant because of social factors that prevent patients from attending classes or doing home practice (e.g., unreliable internet, no access to a computer)

Primary outcomes:
measure: Feasibility of the Virtual Mind-Body Exercises program as measured by enrollment rate
timeFrame: 1 year
Secondary outcomes:
measure: improving patient-reported outcomes (PROs)
timeFrame: 1 year
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge (Consent Only)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth (Consent Only)
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen (Consent Only)
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Suffolk- Commack (Consent Only)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester (Consent Only)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau (Consent Only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Alice Wei, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02826356: Analysis of the Availability of the Treatments for ACE-I and ARB-induced Angioedema
Official title: Efficient Treatments for ACE-I and ARB-induced Angioedema Exist and Should be Available to All Patients. Analysis of Their Availability and Influencing Factors in the Area Around Lyon, France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ACE-I and ARB-induced Angioedema.
Keywords: Angioedema
Emergency treatment
Treatment availability
Health Equity
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 38
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with a specific treatment for bradykinin-mediated angioedema for a severe attack of angioedema due to ACE-inhibitors or ARB during the study period.

Brief summary: Specific treatments for angiotensin-converting-enzyme inhibitor (ACE-I) and angiotensin-receptor-blocker (ARB)-induced angioedema exist. Early access to these treatments is challenging because they are expensive and have short shelf lives making it illusory that all emergency department (ED) stock them. The aim of this retrospective study was to define, for each patient with a confirmed ACE-I or ARB-induced angioedema, at which step of the care, the specific treatment was administered. The second objective was to analyse the availability of these treatment in the area around Lyon, France and the factors that may influence it.


Eligibility criteria: Inclusion Criteria:

* Every patient followed for the first time in our reference center for severe confirmed ACE-I or ARB-induced angioedema. Data were analyzed from patients attended either in a specialized angioedema consultation or during a hospitalization in our intensive care unit.
* Severe attack was defined either by its localization over the shoulder or by an severe abdominal attack.

Exclusion Criteria:

- Patients which received no specific treatment (icatibant, C1-inhibitor concentrate) were excluded.

Primary outcomes:
measure: Step of the care allowing the patients to benefit from a specific treatment.
timeFrame: October 2010 to December 2014
Secondary outcomes:
measure: Epidemiological characteristics
timeFrame: October 2010 to December 2014
measure: Triggering treatments
timeFrame: October 2010 to December 2014
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon, Département d'Anesthésie-Réanimation, Hôpital Edouard Herriot, Lyon, France.
Study officials:
affiliation: Hospices Civils de Lyon, Département d'Anesthésie-Réanimation, Hôpital Edouard Herriot, Lyon, France.
name: Bernard FLOCCARD, MD
role: PRINCIPAL_INVESTIGATOR
References: