louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01839799: A Randomized Phase II/Genomic Trial of Two Chemotherapy Regimens in Patients With Resected Pancreatic Adenocarcinoma
Official title: A Randomized Phase II/Genomic Trial of Two Chemotherapy Regimens in Patients With Resected Pancreatic Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pancreatic Adenocarcinoma
Keywords: Patients
with
resected
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2013-04-25
Enrollment: 32
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: Determine the relapse-free survival of resected pancreatic cancer patients following two novel regimens with activity in advanced disease.

Detailed description: This trial is a randomized Phase II study of FOLFIRINOX versus gemcitabine/abraxane in patients with completely resected pancreatic cancer (Stages I-III). Patients will receive eight weeks of chemotherapy, then 5-FU/radiation, then another 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Patients must have histologically or cytologically confirmed evidence of pancreatic carcinoma.
* Patients must have had all gross disease resected (R0 or R1 resection, patients who underwent an R2 resection are not eligible).
* Patients must have had no prior chemotherapy or radiation therapy for pancreatic cancer.
* Age \> 18 years.
* Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
* Patients must have normal organ and marrow function measured within 2 weeks, prior to registration as follows:

Absolute Neutrophil Count (ANC) \> 1,500/µL Platelets \> 100,000/µL Total bilirubin less than 2-fold upper limit of normal (ULN) Aspartate Aminotransferase (AST)/alanine aminotransferase (ALT)\<2.5X institutional upper limit of normal Creatinine clearance \> 60mL/min for patients with creatinine levels above institutional normal.

* Patients must be \> 4 weeks and \< 12 weeks post-surgery at time of study registration.
* Women of childbearing potential and sexually active males are strongly advised to use appropriate contraceptive measures.
* Women must not be pregnant or breast-feeding.

Exclusion Criteria:

* Patients receiving any other investigational agents.
* Patients with known metastases.
* Patients with wounds that have not fully healed.

Primary outcomes:
measure: Number of Participants With Relapse-free Survival
timeFrame: 20 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Peter O'Dwyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02056899: Maintenance Gabapentin to Prolong Pregnancy.
Official title: Effect of Maintenance Gabapentin Therapy on the Rate of Premature Birth in Women With Preterm Labor After Receiving Tocolysis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Preterm Labor, Premature Birth
Keywords: Preterm labor, premature birth, gabapentin
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
First posted: 2014-02-06
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a pilot study to evaluate the tolerability and effects of maintenance gabapentin therapy on the rate of premature birth in women who have had preterm labor.


Eligibility criteria: Eligibility Criteria:

1. Healthy 18-45 year old female with singleton pregnancy, 20-34 weeks gestation, without ruptured membranes.
2. Preterm labor defined as regular uterine contractions of at least 6/hour for ≥ 1 hour with ≥ 1cm of cervical dilation or ≤ 2.5cm cervical length or any documented cervical change from the initial pelvic exam.
3. Cervical dilation not more than 4cm.
4. Initiation of a tocolytic agent (e.g. magnesium sulfate, nifedipine, indomethacin) within the previous 72 hours.
5. Pregnancy not conceived through in-vitro fertilization (IVF) due to the known higher rates of congenital defects associated with this procedure.30
6. No placenta praevia or abruptio placentae or cervical cerclage.
7. No intra-uterine growth restriction or non-reassuring fetal status.
8. No known serious fetal malformations.
9. No chorioamnionitis or medical/psychiatric/substance abuse comorbidity that may complicate the pregnancy or interfere with the subject's ability to comply with study procedures in the opinion of Dr. Guttuso or the subject's obstetrician.
10. No history of suicide attempt. No suicidal thoughts over past 6 months.
11. Not currently receiving gabapentin, pregabalin, progesterone or a known teratogenic medication and no known allergy to gabapentin therapy.

Primary outcomes:
measure: Rate of premature birth (before 37 weeks gestation)
timeFrame: At delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
References:
Clinical trial NCT00825799: Serum Markers as a Bioassay for Unipolar Depression
Official title: Validation of Serum Markers as a Bioassay for Unipolar Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Depression
Keywords: biomarker
depression
blood test
Lead sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Sponsor class: OTHER
Collaborators: name: Ridge Diagnostics Inc.
First posted: 2009-01-21
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects are recruited from the community by advertisement.

Brief summary: The goal of the study is to validate a biomarker assay for unipolar depression based on serum proteins involved in inflammation, metabolism, and stress response. The study will compare patients with a current major depressive episode to individuals with no history of depression. The hypothesis is that the assay can serve as a diagnostic tool that would be more objective than standard diagnostic questionnaires.


Eligibility criteria: Inclusion Criteria (Depressed):

* Aged 18 to 60.
* Meets DSM-IV criteria for Unipolar Major Depression, either single or recurrent.
* 21 item Hamilton Depression rating scale score greater than 18.
* Capable of providing informed consent.
* Has an established residence and phone number.

Exclusion Criteria:

* Meets DSM-IV criteria for Bipolar Disorder, Schizophrenia, Schizoaffective disorder or other major Axis I Psychiatric disorders (except for depression and phobia per above).
* Addison's Disease, Cushing's Disease, or other known dysfunction of the HPA-cortisol axis.
* Rheumatoid arthritis, lupus, or other condition associated with increased inflammation.
* Regular use of non-steroidal anti-inflammatory medications, steroids, or other medications know to interact with the inflammatory process of the HPA axis.
* A medical condition or regular use of a mediation, which I the opinion of the investigator is likely to influence the inflammatory or HPA responses.
* Pregnancy.
* Meets DSM-IV criteria for substance abuse or dependence in the last month.
* Regular cigarette smoking.
* History of fainting or other significant adverse event during blood drawing in the past.

Primary outcomes:
measure: Protein biomarker MDDScore.
timeFrame: 0 weeks
Secondary outcomes:
measure: Score on Hamilton Depression Rating Scale (HDRS).
timeFrame: 0 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Steward St. Elizabeth's Medical Center
state: Massachusetts
Study officials:
affiliation: Steward St. Elizabeth's Medical Center
name: Michael E. Henry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01560299: Evaluation of Optimal Time of Methimazole Discontinuation Before Radio-iodine Therapy in Hyperthyroid Grave's Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Graves Disease
Keywords: hyperthyroidism
radio-iodine
I-131
methimazole
graves disease
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-03-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Iodine therapy is the best treatment for graves disease.Most patients receive methimozale prior to radio-iodine treatment. This may decrease treatment response to iodine therapy.

Some physicians advice to discontinue methimazole 3 days before radioiodine therapy and others prefer longer off - methimazole period which bothers most patients. This study aimed to evaluate optimum time for methimazole discontinuation in graves disease.


Eligibility criteria: Inclusion Criteria:

* age 18-65
* graves disease(TSH\<0.1 \&increased FT4 \& positive TSI
* one or more bartlena criteria for radio-iodine therapy
* 24 hour RAIU\>25%
* euthyroidism after methimazole treatment

Exclusion Criteria:

* pregnancy or lactation
* moderate or severe graves ophthalmopathy
* CHF or coronary heart disease
* palpable thyroid nodule
* lithium or amiodarone or lugol or ipodate treatment
* recent imaging with contrast agent
* very large goiter(more than 150 gram)

Primary outcomes:
measure: thyroid function tests over one year after radioiodine therapy
timeFrame: months 1 , 3 ,6,9,12
Secondary outcomes:
Other outcomes:
Locations:
city: Mashad
country: Iran, Islamic Republic of
facility: Mashad University of Medical Sciences
state: Khorasan Razavi
Study officials:
affiliation: Mashhad University of Medical Sciences
name: rasoul zakavi, associate professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01656499: Effect of AXOS on the Colon Metabolism in Healthy Volunteers
Official title: Effect of AXOS on the Colon Metabolism in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gut Health
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2012-08-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to evaluate the effect of AXOS on parameters of colon metabolism and gut health


Eligibility criteria: Inclusion Criteria:

* healthy volunteers
* regular dietary pattern (3 meals/day)
* age: 18-45y
* BMI: 18,5-27 kg/m2

Exclusion Criteria:

* intake of antibiotics 1 month prior to the study
* abdominal surgery in the past, with the exception of appendectomy
* intake of medication influencing the gastro-intestinal system 14 days prior to the study
* in treatment at a dietician
* serious liver- or kidney failure
* vegetarians
* intake of pre- and/or probiotics
* Exposure to radioactivity 1 year prior to the study

Primary outcomes:
measure: Fecal water toxicity
timeFrame: Participants are followed for 10 weeks, with measurements on 4 specific time points
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven/KU Leuven
state: Vlaams-Brabant
Study officials:
References:
Clinical trial NCT06202599: Fruquintinib-based Treatment for Refractory Bone and Soft Tissue Sarcomas After Several Lines of TKIs' Resistance
Official title: Fruquintinib-based Treatment for Refractory Bone and Soft Tissue Sarcomas After Several Lines of TKIs' Resistance:A Multicenter Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Sarcoma
Soft Tissue Sarcoma
Refractory Tumor
Keywords: Fruquintinib
Osteosarcoma
Ewing sarcoma
Soft Tissue Sarcomas
TKIs
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 124
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: Patients who received fruquintinib-based treatment with refractory bone and soft tissue sarcomas in Peking University People's Hospital and The Second Affiliated Hospital ZheJiang University School of Medicine was included.

Brief summary: This multicenter retrospective study assessed the efficacy and safety of fruquintinib-based treatment in patients with refractory bone and soft tissue sarcomas after several lines of TKIs' resistance.

Detailed description: The short-lived duration of disease control and secondary drug resistance have posed a threat to the effect of TKIs. Fruquintinib is a novel TKI with a high selectivity of VEGFR-1,2,3 without metabolism by liver enzymes and was approved for application in mCRC. Serious drug resistance and the unique characteristics of fruquintinib have prompted us to verify whether this drug can reverse TKIs' resistance at a higher dose.

Eligibility criteria: Inclusion Criteria:

1. Histologically confirmed bone or soft tissue sarcomas;
2. Progressed after several lines of therapy;
3. Previously treated with other TKIs before fruquintinib;
4. Received fruquintinib-based treatment;
5. Measurable lesions according to the Response Evaluation Criteria for Solid Tumors (RECIST) version1.1;
6. Eastern Cooperative Oncology Group (ECOG) performance status ≤3

Exclusion Criteria:

1. Failure to complete regular follow-up after administration.
2. Discontinued the fruquintinib-based treatment due to neither progression nor unacceptable toxicity.

Primary outcomes:
measure: PFS
timeFrame: 4months
Secondary outcomes:
measure: OS
timeFrame: 1year
measure: ORR
timeFrame: 1year
measure: DCR
timeFrame: 1year
measure: AEs
timeFrame: 1year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
Study officials:
affiliation: Musculoskeletal Tumor Center of Peking University People's Hospital
name: Lu Xie, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00444899: Clinical and Economic Benefits of Cardiovascular Risk Management by a Dietician in Type 2 Diabetes Patients
Official title: Clinical and Economic Benefits of Cardiovascular Risk Management by a Dietician in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Type 2 Diabetes
Keywords: Intensive treatment
dietician
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2007-03-08
Enrollment: 101
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: Worldwide, health systems and practitioners are facing obesity epidemics. High blood pressure, dyslipidemia and diabetes prevalence will explode during the 21st century.

The two main objectives of this 2-year controlled prospective study are:

1. to demonstrate that, for patients with high blood pressure, diabetes and dyslipidemia, dietician conducted survey and management in combination with annual endocrinologist follow-up enable both attainment and maintenance of recommended blood pressure, glycemic and lipid goals, as well as smoking cessation;
2. to demonstrate that dietician management is more cost effective than conventional care provided by general practitioners and endocrinologists.

Results are expected to show significantly different cardiovascular risk profiles (BMI and waist circumference, systolic and diastolic blood pressure, LDL-C, triglycerides and Total cholesterol/HDL ratio, HbA1c, smoking) between baseline and after 2 years follow-up. Sample size was determined in order to show statistically significant differences between the two groups.

Results will document for the benefit of care givers, health economists and policy makers alike an innovative and integrated model of care which is expected to be effective at the patient level as well as cost effective with respect to the increasing financial burden of diabetes on the health system.


Eligibility criteria: Inclusion Criteria:

* HbA1c \> 7%
* More than 2 follow-up visits

Primary outcomes:
measure: Lipid profile
timeFrame: 36 months
measure: Blood pressure
timeFrame: 36 months
measure: HbA1c
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre de recherche clinique Étienne-Le Bel du CHUS
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Patrice Perron, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01301599: Comparison Between Alpha Blocker Monotherapy and 5ARI Monotherapy Following Combination Therapy in Benign Prostatic Hyperplasia (BPH)
Official title: Comparison Between Alpha Blocker Monotherapy and 5-alpha-reductase Inhibitor Monotherapy Following Combination Therapy in Benign Prostatic Hyperplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Benign Prostatic Hyperplasia
Keywords: Benign Prostatic Hyperplasia
alpha blocker
5-alpha reductase inhibitor
combination therapy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-02-23
Enrollment: 308
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to investigate the comparison between alpha blocker monotherapy and 5-alpha-reductase inhibitor monotherapy following combination therapy in benign prostatic hyperplasia.


Eligibility criteria: Inclusion Criteria:

1. Male aged 45 years old and above (with no upper limit of age)
2. patients who underwent combination therapy of alpha blocker and 5 ARI for more than 9 months
3. IPSS ≤ 12
4. Ability and willingness to correctly complete the micturition diary and questionnaire
5. Capable of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risks and benefits

Exclusion Criteria:

1. An anticholinergic or antidiuretic if started less than 3 months prior to screening
2. Patients who had surgical treatment due to LUTS
3. Patients with suspected neurogenic bladder disorder
4. Patients with cancer of any type including cancer of the prostate or bladder
5. Patients with urethral stricture or bladder neck contracture
6. Patients with suspicious chronic prostatitis/chronic pelvic pain syndrome
7. Acute bacterial prostatitis less than 6 months prior to screening
8. Symptomatic acute urinary tract infection (UTI) less than 1 months prior to screening
9. Patients who had underwent prostatic biopsy less than one month prior to screening
10. Patients who had unstable angina or cerebral vascular disease less than 6 months prior to screening

Primary outcomes:
measure: Numeric change of IPS and Numeric change of IPSS total score
timeFrame: from baseline to 12 months of treatment
Secondary outcomes:
measure: Changes in patients' symptom questionnaires : IPSS, ICIQ male LUTS
timeFrame: from baseline to 12 months of treatment
measure: Changes in urodynamic parameters : maximal flow rate and PVR
timeFrame: from baseline to 12 months of treatment
measure: change in finding of TRUS
timeFrame: from baseline to 12 months of treatment
measure: Numeric Change and percent change in PSA
timeFrame: from baseline to 12 months of treatment
measure: safety evaluation : incidence and severity of adverse events
timeFrame: 12 months of treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Kyu-Sung Lee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02559999: Objective Markers of Pain Perception in Humans
Official title: Objective Markers of Pain Perception in Humans: a Study in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Healthy Volunteers
Pain
EEG
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2015-09-25
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Determine objective markers of pain perception remains a major scientific and medical issue. Various tools have been proposed to objectify pain, but their adaptability to different clinical contexts are limited. Our working hypothesis considers that the research for markers of immediate pain perception should be based on an electrophysiological approach, based on the combined analysis of EEG and autonomic responses.

Detailed description: This project aims to study the cortical and autonomic responses induced by tonic painful stimulation compared to those induced by comparable sensory and stressful stimulations, by combining high density EEG, cutaneous sympathetic, cardiovascular and pupillary recordings.

Eligibility criteria: Inclusion Criteria:

* Affiliate or beneficiary of social security
* Signature of consent

Exclusion Criteria:

* History of cardiovascular disease (vagal syncope, hypertension, etc ...), renal, metabolic (diabetes ...), psychiatric (depression, etc ...) or neurological (seizure, etc ...) syndromes;
* Reynaud's syndrome;
* Raynaud's disease;
* Acrocyanosis;
* Known rhythm disorders;
* Participation at the same time in another clinical trial;
* Taking a medical treatment;
* Suffering from acute (complaint of pain in the week before the test) or chronic pain,
* Allergic to conductive gel for electrodes.

Primary outcomes:
measure: EEG Gamma power.
timeFrame: Baseline
Secondary outcomes:
measure: ratio of low to high frequency spectral powers
timeFrame: Baseline
measure: Magnitude of the sympathetic cutaneous reactivity
timeFrame: Baseline
measure: Amplitude of pupillary dilation
timeFrame: Baseline
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de LYON
city: Saint-etienne
country: France
facility: CHU de SAINT-ETIENNE
Study officials:
affiliation: CHU de SAINT-ETIENNE
name: Roland PEYRON, MD
role: PRINCIPAL_INVESTIGATOR
References: