louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04559308: The Effect of Metformin on Breast Cancer Patients
Official title: The Effect of Metformin on Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Metformin
Breast cancer
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
Collaborators: name: Ahram Canadian University
First posted: 2020-09-22
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is an open-labeled, parallel, randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Several clinical trials have addressed the promising anticancer effect of metformin on the survival benefits, clinical response, and pathological response of breast cancer patients.

Therefore, this study will assess the anticancer effect of metformin when added to the neoadjuvant chemotherapy protocol of non-diabetic breast cancer patients. In addition to, the impact of metformin addition to the neoadjuvant chemotherapy on the quality of life of breast cancer patients.

Detailed description: This study is conducted to assess the effect of metformin addition to the chemotherapy protocol of non-diabetic breast cancer patients compared to the control group (non-metformin users) in the neoadjuvant setting. Evaluation of the the clinical benefit rate and the rate of pathological complete response will be conducted. In addition, a correlation between the beneficial effect of metformin and the serum concentration of metformin. Also, a comparison in the quality of life between the metformin group and the control group will be evaluated using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30) and (EORTC QLQ BR45) questionnaires will be done.

Eligibility criteria: Inclusion Criteria:

1. Non-diabetic breast cancer patients, receiving neoadjuvant chemotherapy treatment.
2. Female Age between 18- 65 years.
3. Written informed consent.

Exclusion Criteria:

1. Known hypersensitivity reaction to Metformin.
2. Intolerable Metformin GI complaints.
3. Patients at risk of lactic acidosis.
4. Diabetic breast cancer patients.
5. Body Mass Index \< 18.5 (underweight breast cancer patients).
6. Renal impairment, eGFR \<45 mL/min/1.73 m².

Primary outcomes:
measure: Clinical benefit rate (Tumor size)
timeFrame: 8 months
Secondary outcomes:
measure: Pathological complete response
timeFrame: 8 months
measure: Number of participants with metformin-related adverse events
timeFrame: 8 months
measure: The effect of metformin on the quality of life of breast cancer patients
timeFrame: 8 months
measure: The effect of metformin on the quality of life of breast cancer patients
timeFrame: 8 months
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-suef university
Study officials:
affiliation: Beni-Suef University
name: Ahmed A El Berry, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00759408: The Role of Endothelin in Pulmonary Hypertension
Official title: The Role of Endothelin in Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Hypertension
Keywords: primary pulmonary hypertension
secondary pulmonary hypertension due to left heart failure
secondary pulmonary hypertension due to other causes
patients without pulmonary disease or pulmonary hypertension
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2008-09-25
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is is to determine the effect, on the lung circulation, of BQ-123, an investigational compound which is not approved by the FDA.

Detailed description: Endothelin levels are increased in patients with pulmonary hypertension. We wish to compare the effect of an endothelin antagonist on pulmonary hypertension due to a variety of causes.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers or known diagnosis of pulmonary hypertension

Exclusion Criteria:

* hypertension due to other reasons (not pulmonary)

Primary outcomes:
measure: Pulmonary Vascular Resistance (PVR)
timeFrame: Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)
Secondary outcomes:
measure: Systemic Vascular Resistance (SVR)
timeFrame: Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)
measure: Mean Pulmonary Artery Pressure (PAP)
timeFrame: Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)
measure: Cardiac Output (CO)
timeFrame: Baseline and time points 2, 3, 4, and 5 (as described in Outcome Measure Description)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Mark A Creager, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05053308: Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement
Official title: Proportional Dose of Sublingual Fentanyl Tablet Based on Daily Opioid Requirement Versus Intravenous PCA for Breakthrough Cancer Pain: A Prospective, Randomized, Open Label, Non Inferiority Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cancer Pain
Breakthrough Pain
Lead sponsor: Seoul National University
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Proportional dose of sublingual fentanyl tablet (Narco®) based on daily opioid requirement versus intravenous PCA for breakthrough cancer pain: A prospective, randomized, open-label, noninferiority trial.

Detailed description: Based on the previous around-the-clock analgesic demand compared to IV PCA in cancer pain patients to prepare the basis for the administration of fentanyl sublingual tablets with an initial dose.

Eligibility criteria: Inclusion Criteria:

* Age 19-80
* Cancer pain
* Admission for the control of cancer pain or consultation for the treatment of cancer pain
* Stable vital sign
* ECOG status ≤ 3 for more than 1 or 2 months
* Opioid-tolerant state
* No history of using sublingual fentanyl

Exclusion Criteria:

* Noncancer pain
* Opioid naive
* baseline NRS pain score\> 4
* Current using sublingual fentanyl
* Difficult to assess cancer pain
* no evidence of disease(cancer)
* Planned surgical resection of cancer
* Allergy to fentanyl
* Severe renal and/or liver function
* Severe respiratory depression or uncontrolled COPD

Primary outcomes:
measure: Change in 11-point scale NRS pain score
timeFrame: 30 minutes after administration
Secondary outcomes:
measure: Change in 11-point scale NRS pain score
timeFrame: 15, 45, 60 minutes after administration
measure: sum of pain intensity difference(SPID)
timeFrame: 60 minutes after administration
measure: number of additional doses
timeFrame: immediately after the intervention
measure: Pain interference
timeFrame: immediately after the intervention
measure: Insomnia
timeFrame: immediately after the intervention
measure: Depression
timeFrame: immediately after the intervention
measure: Satisfaction scale
timeFrame: immediately after the intervention
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University Hospital
name: Jee Youn Moon, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00002108: 3TC (Lamivudine; GR109714X) Open-Label Program
Official title: 3TC (Lamivudine; GR109714X) Open-Label Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Antiviral Agents
Zidovudine
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To make lamivudine (3TC) available to patients with progressive, symptomatic HIV disease who cannot participate in a controlled clinical trial and who are refractory or unable to tolerate other therapies. To collect data pertaining to the safety of 3TC at two dose levels. To evaluate the effect of 3TC on markers of hepatitis B in co-infected patients at five to ten selected sites.

Detailed description: Patients 12 years and older are randomized to receive one of two doses of 3TC for a duration determined by the patient's physician or until termination of the program. Patients \< 12 years receive a lower dose of 3TC. Patients are followed monthly. For selected sites only, serum samples are collected every 3 months from patients identified as HBsAg positive.

PER 02/28/95 AMENDMENT: Patients enrolled prior to 3/1/95 may remain on their assigned monotherapy dose or change to combination therapy with 3TC and zidovudine.

Eligibility criteria: Patients must:

* Have progressive, symptomatic HIV disease.
* Have a mean CD4 count \<= 99 cells/mm3 for adults and \<= 300 cells/mm3 for children (original design was CD4 count \<= 300 cells/mm3 for both adults and children).
* Be unable to participate in a controlled trial.
* Be refractory to or unable to tolerate other therapies.
* Be able to attend clinic on a monthly schedule.
* Have consent of parent or guardian if under the age of consent.

NOTE:

* If a pregnant or breast-feeding woman requests enrollment, her physician should contact Glaxo staff directly to discuss the case.

Practice of unsafe sex.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Morristown
country: United States
facility: Kern - McNeill International
state: New Jersey
Study officials:
References:
citation: Pluda J, Cooley T, Montaner J, McCaffrey R, Wainberg M, Yarchoan R. Phase I/II study of 3TC (GR109714X) in adults with ARC or AIDS. Int Conf AIDS. 1993 Jun 6-11;9(1):69 (abstract no WS-B26-2)
Clinical trial NCT01891708: VEGFRs Predict Bevacizumab Benefit in Advanced Non Small Cell Lung Cancer
Official title: VEGFRs Predict Bevacizumab Benefit in Advanced Non Small Cell Lung Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non Small Cell Lung Cancer
Brain Metastasis
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2013-07-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: advanced non small cell lung cancer patients with brain metastatic disease

Brief summary: a. VEGFRs may be the biomarker which can predict the effect of bevacizumab in non small cell lung cancer

Detailed description: 1. non small cell lung cancer (non squamous carcinoma)
2. ECOG 0-1
3. from 18-75 years old

Eligibility criteria: Inclusion Criteria:

* non squamous cell non small cell lung cancer
* with measurable disease
* ECOG 0-1

Exclusion Criteria:

- patients received surgery in recent 4 weeks

Primary outcomes:
measure: PFS
timeFrame: 6 months
Secondary outcomes:
measure: OS
timeFrame: 18 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
name: Li Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03677908: Plasticity of Neonatal Neuronal Networks Temporal Theta Activity, the First Endogenous
Official title: Plasticity of Neonatal Neuronal Networks in Very Premature Infants: Source Localization of Temporal Theta Activity, the First Endogenous Neural Biomarker, in Temporoparietal Areas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Birth
Keywords: Temporoparietal Areas
Neural Biomarker
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2018-09-19
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 28 healthy premature infants follow-up between the Gestational Ages of 26 and 32 wGA between December 2014 and June 2015. These infants were divided into two groups accord- ing to age (26-30 wGA and 30-32 wGA).

Brief summary: Temporal theta slow-wave activity (TTA-SW) in premature infants is a specific signature of the early development of temporal networks, as it is observed at the turning point between non-sensory driven spontaneous local processing and cortical network functioning. The role in development and the precise location of TTA-SW remain unknown. Previous studies have demonstrated that preterms from 28 weeks of gestational age (wGA) are able to discriminate phonemes and voice, supporting the idea of a prior genetic structural or activity-dependent fingerprint that would prepare the auditory network to compute auditory information at the onset of thalamocortical connectivity. They recorded TTA-SW in 26-32 wGA preterms. The rate of TTA-SW in response to click stimuli was evalu- ated using low-density EEG in 30 preterms. The sources of TTA-SW were localized by high-density EEG using different tissues conductivities, head models and mathematical models.

Detailed description: Temporal theta slow-wave activity (TTA-SW) in premature infants is a specific signature of the early development of temporal networks, as it is observed at the turning point between non-sensory driven spontaneous local processing and cortical network functioning. The role in development and the precise location of TTA-SW remain unknown. Previous studies have demonstrated that preterms from 28 weeks of gestational age (wGA) are able to discriminate phonemes and voice, supporting the idea of a prior genetic structural or activity-dependent fingerprint that would prepare the auditory network to compute auditory information at the onset of thalamocortical connectivity. They recorded TTA-SW in 26-32 wGA preterms. The rate of TTA-SW in response to click stimuli was evalu- ated using low-density EEG in 30 preterms.

Eligibility criteria: Inclusion Criteria:

* healthy premature infants
* Gestational Ages of 26 and 32 wGA

Exclusion Criteria:

* unhealthy premature infants

Primary outcomes:
measure: specific temporal TTA-SW
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU AMIENS
name: Fabrice Wallois, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05206708: Assesment of the Efficacy of Personalized Parent-child Psychotherapy in Children Under 3 Years Old
Official title: Assesment of the Efficacy of Personalized Parent-child Psychotherapy Evaluating Symptoms in Children Under 3 Years Old and Parent-child Interaction.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Behavior Disorders
Parent-Child Relations
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 234
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to assess the efficacy at 4 months of a personalized strategy comparatively to a standard Psychodynamic Integrative Therapy, on childrens' symptom improvment

Detailed description: 3 evaluations are performed: before treatment, at the end of the treatment and one year after the treatment.

evaluations include assessment of: children's symptom parent-infant interaction quality parental competencies parental perception of the child by his/her parent parent-therapist alliance hair cortisol concentration

Eligibility criteria: Inclusion Criteria:

* Families who are requesting a consultation for functional or behavioural problems of their child
* Children under the age of 3

Exclusion Criteria:

* Parents suffering from a severe untreated psychiatric disorder
* Difficulties in speaking French
* Children with Autistic spectrum disorder
* Families already in care

Primary outcomes:
measure: Efficacy of therapy
timeFrame: Month 4
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Montpellier
country: France
facility: CHU de Montpellier
city: Paris
country: France
facility: GHU Paris Psychiatrie et Neurosciences
city: Reims
country: France
facility: CHU de Reims
Study officials:
affiliation: CHU Besançon
name: Lauriane Coady-Vulliez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03390608: Prognostic and Predictive Factors for Small Breast Tumors
Official title: Prognosis, Prognostic Factors and Predictive Factors in Centimeter or Subcentimeter Node-negative Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: The Swedish Society of Medicine
name: The Swedish Breast Cancer Association (BRO)
name: Swedish Breast Cancer Group
First posted: 2018-01-04
Enrollment: 35002
Sex: FEMALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of all Swedish women operated for centimeter or subcentimeter breast cancer who are included in the regional breast cancer registries (1977 to 2007) or the national breast cancer registry (2008 onwards).

Brief summary: Because of mammography screening increasingly more women are diagnosed with centimeter or subcentimeter node-negative breast cancer (i.e., T1abN0); these tumors account for approximately 19% of all newly diagnosed breast cancers in Sweden. Although the long term relapse-free survival rates among patients with such tumors is as high as ≥90%, some reports suggest that certain patient subgroups may have rates \<75%. Firmly established prognostic and predictive factors for patients with T1abN0 tumors are, however, lacking. This is a nationwide, register-based cohort study investigating prognostic and predictive factors in women with centimeter or subcentimeter breast cancer. The study hypotheses are: 1) Established prognostic and/or predictive factors in overall breast cancer are prognostic and/or predictive factors also in centimeter or subcentimeter node-negative breast cancer; 2) The established relative reduction in risk of recurrence and death of adjuvant treatment for overall breast cancer are similar in centimeter or subcentimeter node-negative breast cancer.


Eligibility criteria: Inclusion Criteria:

1. Female.
2. Operated for centimeter or subcentimeter breast cancer.

Exclusion Criteria:

1. Previous breast cancer.
2. Metastatic breast cancer at diagnosis.

Primary outcomes:
measure: Breast cancer specific death
timeFrame: January 1, 1977 to December 31, 2014
Secondary outcomes:
measure: Death from any cause
timeFrame: January 1, 1977 to July 30, 2016
measure: Metachronous breast cancer
timeFrame: January 1, 1977 to July 30, 2016
Other outcomes:
Locations:
city: Solna
country: Sweden
facility: Karolinska Instiutet
Study officials:
References:
Clinical trial NCT02081508: Consolidation & Interference in Multiple Sclerosis
Official title: Consolidation & Interference in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Memory
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2014-03-07
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to investigate whether minimizing interference improves memory in multiple sclerosis.

Detailed description: The ability to form new long-lasting memories is important for successful independent living and a high quality of life. Roughly half of the individuals diagnosed with Multiple Sclerosis (MS) have difficulty remembering new information and this is likely associated with poor acquisition of new information. There are only a limited number of studies that have investigated memory consolidation in MS. The current study will investigate the role of interference during the consolidation time period of memory formation.

Eligibility criteria: Inclusion Criteria:

* If you are between the ages of 18-65.
* If you have a diagnosis of Multiple Sclerosis (MS) or are medically healthy.
* If you have MS, you have not had a flare up of MS symptoms in the past month.
* You do not have other neurological issues such as, Epilepsy or Stroke.
* You do not have a significant history of psychiatric problems or a current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder .
* You do not have a significant history of drug or alcohol abuse.
* You can read and speak English fluently.
* You are not currently taking steroids.

Exclusion Criteria:

* You are younger than 18 years old.
* You are older than 65 years old.
* You have had a prior stroke or neurological disease other than MS.
* You have a history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Bipolar Disorder.
* You have a significant alcohol or drug abuse history.
* You are currently taking steroids.

Primary outcomes:
measure: Recall Proportion
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
References: