louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00268970: Satraplatin and Paclitaxel in Patients With Advanced Non-small Cell Lung Cancer
Official title: Phase 2 Trial of First-Line Therapy With Satraplatin and Paclitaxel in Patients With Unresectable Stage III or IV Non-small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-small Cell Lung Cancer
Keywords: Advanced non-small cell lung cancer (NSCLC)
Lead sponsor: Agennix
Sponsor class: INDUSTRY
First posted: 2005-12-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to study the combination regimen of satraplatin and paclitaxel in the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC).

Detailed description: This trial is designed to study the efficacy and safety of a novel oral platinum analog, satraplatin, in combination with another chemotherapy drug, paclitaxel, for the first line of treatment (patients who have not received chemotherapy for disease that has metastasized) of patients with advanced NSCLC.

WHAT IS SATRAPLATIN:

Satraplatin is a member of the platinum-based class of chemotherapy drugs. Platinum-based drugs have been clinically proven to be one of the most effective classes of anticancer therapies. Unlike the currently marketed platinum-based drugs, satraplatin can be given orally.

Eligibility criteria: Inclusion Criteria:

* Histologically confirmed advanced NSCLC
* Patients must not have received any prior antineoplastic chemotherapy or investigational product for lung cancer prior to study entry.
* Patients must have at least one unidimensionally measurable lesion definable by magnetic resonance imaging (MRI) or computed tomography (CT) scan.
* ECOG performance status of ≤ 2.

Primary outcomes:
measure: To examine overall response rates in patients with advanced NSCLC treated with a first-line regimen of satraplatin and paclitaxel
timeFrame: 3 months
Secondary outcomes:
measure: To examine time to tumor progression, overall survival, and safety in patients with advanced NSCLC treated with a first-line regimen of satraplatin and paclitaxel
timeFrame: 3 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
Study officials:
References:
Clinical trial NCT03074370: Evaluation of Smile Esthetics in Orthodontically Treated Patients With Bimaxillary-dentoalveolar Protrusion
Official title: Evaluation of Smile Esthetics in Orthodontically Treated Adult Female Patients With Bimaxillary-dentoalveolar Protrusion: A Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bimaxillary Protrusion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-03-08
Enrollment: 19
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 24
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Study models of orthodontically treated Egyptian adult female patients with bimaxillary dentoalveolar protrusion .

Brief summary: Evaluation of Smile Esthetics in Orthodontically Treated Adult Female Patients with Bimaxillary-dentoalveolar Protrusion.

A Retrospective Cohort Study.


Eligibility criteria: The selected records should meet the following inclusion criteria:

Pre treatment:

1. Full permanent dentition
2. No dental nor any craniofacial anomalies
3. Molar Class I with bimaxillary-dentoalveolar protrusion
4. No excessive over jet or overbite

Treatment mechanics:

1. All patients treated with extraction of four 1st premolars
2. Retraction of anterior teeth using maximum anchorage mechanics

Post treatment:

1. Canine 1 relation
2. Molar I relation

Exclusion criteria :

Any orthodontic records without the previously mentioned pre and posttreatment inclusion criteria

Primary outcomes:
measure: Gingival display
timeFrame: Change from Baseline gingival display, at an average 24 months
Secondary outcomes:
measure: Lateral negative space
timeFrame: Change from Baseline lateral negative space, at an average 24 months
measure: Smile arc
timeFrame: Change from Baseline smile arc, at an average 24 months
measure: Lip line
timeFrame: Change from Baseline lip line, at an average 24 months
measure: Smile width
timeFrame: Change from Baseline smile width, at an average 24 months
measure: Smile height
timeFrame: Change from Baseline smile height, at an average 24 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Asmaa Aboelnaga
Study officials:
References:
Clinical trial NCT01648699: Safety and Efficacy Study of Osmotic Release Oral System (OROS) Hydromorphone in Participants With Cancer Pain
Official title: Study on the Effectiveness and Safety of OROS Hydromorphone in Pain Management Among Patients With Cancer Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain
Keywords: Pain
Cancer
Osmotic Release Oral System
OROS Hydromorphone
Jurnista
Lead sponsor: Janssen Pharmaceutica
Sponsor class: INDUSTRY
First posted: 2012-07-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effectiveness and safety of Osmotic Release Oral System (OROS) hydromorphone using standardized conversion from prior opioid therapy among participants with cancer pain.

Detailed description: This is a prospective (study following participants forward in time), open-label (all people know the identity of the intervention), single-arm, multi-center (conducted in more than one center) study to evaluate the effectiveness and safety of stable dose of OROS hydromorphone among participants with cancer pain. The duration of this study will be 28 days and will include visits at: Day 0 (Baseline), Day 7, 14 and 28. The OROS hydromorphone will be administered orally for 28 days and dose titration (incremental increase in drug dosage to a level that provides the optimal therapeutic effect) will be done every two days upon administration of dose. Rescue medication (a medication intended to relieve symptoms immediately) of morphine will be permitted throughout the study duration. Efficacy of the participants will primarily be evaluated by Brief Pain Inventory score. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Participant with histological confirmed malignancy
* Participant on stable morphine or 25 milligram oxycodone dose equivalent per day. Stable dose is defined as no dose change for 3 consecutive days and does not require more than 3 doses of rescue medication per day
* Life expectancy of at least 3 months
* Negative urine pregnancy test
* Participants with signed informed consent

Exclusion Criteria:

* Participant intolerant or hypersensitive to hydromorphone or other opioid agonist
* Participant with unstable medical condition
* Participant with renal dysfunction and liver dysfunction
* Participant dependence to opiates
* Inability to take oral medication

Primary outcomes:
measure: Brief Pain Inventory (BPI) Average Score at Baseline
timeFrame: Baseline
measure: Brief Pain Inventory (BPI) Average Score at Day 28
timeFrame: Day 28
Secondary outcomes:
measure: Number of Participants Given Rescue Pain Medications
timeFrame: Day 28
measure: Number of Participants With Categorical Score on Clinical Global Impression Scale as Assessed by Clinician
timeFrame: Day 28
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Pharmaceutica
name: Janssen Pharmaceutica Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT05878899: Postpartum Heparin Against Venous Thromboembolism: a Pilot Randomized Controlled Trial
Official title: Postpartum Heparin Against Venous Thromboembolism: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Thromboembolism
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 77
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In previous attemps to answer the question of risk-benefit of postpartum thromboprophylaxis, researchers were faced with low recruitement rates. The goal of this pilot feasibility randomized controlled trial of postpartum pharmacological thromboprophylaxis is to examine the feasibility (recruitement rate) and participation rate at the Geneva University Hospitals


Eligibility criteria: Inclusion Criteria: adult women within 48h of delivery, with:

* ≥2 of the following risk factors Age ≥35 years Pre-pregnancy BMI 30.0-34.9kg/m2 Current smoking Elective cesarean section Postpartum hemorrhage Antenatal immobility
* and/or ≥1 of the following risk factors: Emergency cesarean section Pre-pregnancy BMI ≥35kg/m2 Known low-risk thrombophilia (heterozygous factor V Leiden; heterozygous G20210 prothrombin mutation) Pre-eclampsia Pre-term delivery (\<37th week of gestation) Peripartum systemic infection (defined as fever with use of antibiotics) Intra-uterine growth restriction (birth weight \<5th percentile)

Exclusion Criteria:

* any indication for therapeutic anticoagulation
* a high-risk of postpartum venous thromboembolism (personal history, high-risk thrombophilia)
* an increased bleeding risk
* a contra-indication to the use of heparin

Primary outcomes:
measure: Recruitement rate
timeFrame: 6 months
measure: Study participation
timeFrame: Within 48 hours after delivery
Secondary outcomes:
measure: Venous thromboembolism
timeFrame: Within 90 day after delivery
measure: Bleeding
timeFrame: Within 90 day after delivery
measure: Surgical site complication
timeFrame: Within 90 day of delivery
measure: Heparin-induced thrombocytopenia
timeFrame: Within 90 day of delivery
measure: Septic pelvic thrombophlebitis
timeFrame: Within 90 day of delivery
measure: All-cause mortality
timeFrame: Within 90 day of delivery
measure: Satisfaction with study intervention
timeFrame: After completion of the 10 days of study drug
Other outcomes:
Locations:
city: Geneve
country: Switzerland
facility: Geneva University Hospitals
Study officials:
References:
Clinical trial NCT03728699: Microbiota Changes in Acute Myeloid Leukemia Patients Undergoing Intensive Chemotherapy
Official title: Microbiota Changes in Acute Myeloid Leukemia Patients Undergoing Intensive Chemotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia
Keywords: AML
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with acute myeloid leukemia (new diagnosis, refractory, or relapsed) undergoing any intensive chemotherapy with expected inpatient stay of \~4 weeks.

Brief summary: This is a prospective, observational study to collect stool and blood from acute myeloid leukemia patients undergoing intensive chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Adults (ages 18 - 99 years) undergoing inpatient intensive chemotherapy for newly diagnosed, refractory, or relapsed AML. Patients may or may not have been exposed to any type of therapy before.
* Any intensive chemotherapy regimen defined as a planned \~4 week inpatient stay. Chemotherapy may be delivered for any number of days and on any schedule. Patients may be discharged from the hospital sooner than 4 weeks if the treating physician choose so, but the expectation at the initiation of chemotherapy must be \~4 weeks of inpatient stay, as is typical.
* Able to provide written voluntary consent before performance of any study related procedure.

Primary outcomes:
measure: Abundance of Phyla
timeFrame: Day 28
measure: Abundance of Genera
timeFrame: Day 28
Secondary outcomes:
measure: Circulating Microbiota Diversity (Blood)
timeFrame: Day 28
measure: Microbiota Diversity (Stool)
timeFrame: Day 28
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Masonic Cancer Center at University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT02535299: Par-4 and Telomere-telomerase System in Type 2 Diabetes Patients Who Received GLP-1 or Metformin Treatment
Official title: The Correlation Between Par-4 and Telomere-telomerase System in the New Dignosised Type 2 Diabetes Patients Who Received GLP-1 Analog or Metformin Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: GLP-1；Metformin；Telomere-telomerase System；Par-4
Keywords: telomere-telomerase
Par-4
GLP-1
metformin
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2015-08-28
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objectives: To investigate the treatment effect between insulin,metformin and Liraglutide; in Type 2 Diabetes in our hospital, in order to investigate the possible mechanism about telomere-telomerase system and Par-4.

Detailed description: 160 Type 2 diabetes in our hospital will divide into 4 groups: group A (40 healthy volunteers), group B (40 patients who give basal and insulin treatment, group C（40 patients who give basal and Liraglutide treatment),group D（40 patients who give basal and metformin treatment). The age, height, weight, blood glucose, glycosylated hemoglobin A1c（HbA1c）,homeostasis model assessment(HOMA-IR), lipid, blood pressure, course of disease, telomere length,telomerase activity will record respectively. And High-sensitive C-reactive protein (HsCRP), Par-4, GST,SOD,GSH-PX,ATF-6,CHOP,XBP-1 and Tumor necrosis factor-α（TNF-α） will detect as Baseline. After each group's treatment, Change from baseline of all indexes will record, Multifactor logistic regression will be analyzed the correlations between each positive indexes.

Eligibility criteria: Inclusion Criteria:

* Newly dignosised type 2 diabetes according to WHO criteria.glycated hemoglobin (HbA1c) was more than 10%;
* Seronegative for antibodies against insulin, islet cells and glutamic acid decarboxylase (GAD);

Exclusion Criteria:

* Type 1 diabetes mellitus,presence of autoimmune diabetes indicated by antibodies to insulin, islet cells, and GAD；
* Gestational diabetes;
* patients with heart, liver, or renal function impairment;presence of severe infections or cerebrovascular disease;

Primary outcomes:
measure: physiological parameter:glycosylated hemoglobin A1c
timeFrame: up to 6 months;
Secondary outcomes:
measure: physiological parameter:the concentration of Par-4
timeFrame: up to 6 months;
measure: physiological parameter:telomere length
timeFrame: up to 6 months;
measure: physiological parameter:telomease activity
timeFrame: up to 6 months;
measure: physiological parameter:TNF-α
timeFrame: up to 6 months;
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Southwest Hospital of the Third Military Medical University
state: Chongqing
Study officials:
References:
Clinical trial NCT05572099: ExoDx Prostate Evaluation in Active Surveillance Patient Population
Official title: ExoDx Prostate Evaluation in Active Surveillance Patient Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostate Cancer
Lead sponsor: Exosome Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-07
Enrollment: 750
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male, 45+ years of age diagnosed with low-grade or favorable-intermediate prostate cancer and on an active surveillance regimen

Brief summary: The goal of this observational study is to test whether the ExoDx Prostate test add value in biopsy decision making to patients with prostate cancer on an active surveillance regimen.

Detailed description: The current trial seeks to evaluate the role of the ExoDx Prostate test in men with low and favorable intermediate prostate cancer undergoing an active surveillance regimen.

Eligibility criteria: Inclusion Criteria:

* Male, 45+ years of age diagnosed with low-grade or favorable-intermediate prostate cancer and on an active surveillance regimen

Exclusion Criteria:

* Clinical symptoms of urinary tract infection at time of enrollment.
* History of invasive treatment for benign prostatic hypertrophy with in 6 months of enrollment.
* Known hepatitis or HIV
* History of concurrent renal/bladder tumors

Primary outcomes:
measure: Develop and evaluate risk-based scoring using the ExoDx Prostate test.
timeFrame: 1yr after last enrolled patient
Secondary outcomes:
Other outcomes:
Locations:
city: Towson
country: United States
facility: Chesapeake Urology
state: Maryland
Study officials:
affiliation: Exosome Diagnostics, Inc.
name: Sonia Kumar, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00924599: A Pilot Study Using Weightloss and Exercise to Prevent Recurring Gestational Diabetes in Obese Women
Official title: Prevention of Gestational Diabetes Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gestational Diabetes
Keywords: Recurring Gestational Diabetes
Prevention
Lead sponsor: California Polytechnic State University-San Luis Obispo
Sponsor class: OTHER
First posted: 2009-06-19
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to examine the feasibility of recruiting and providing a behavioral weight loss program prior to pregnancy to reduce gestational diabetes recurrence.


Eligibility criteria: Inclusion Criteria:

* GDM in last pregnancy
* BMI 30-40
* Age 18-40
* 1-5 years since last pregnancy
* Non-smoking
* English or Spanish speaking
* Planning to have a baby but willing to use birth control during the 3 month weight loss program

Exclusion Criteria:

* 3 or more miscarriages
* History of infertility
* Type 1 or Type 2 diabetes
* Any weight loss since last pregnancy (based on last pre-pregnancy weight)
* History of major psychiatric illness, drug abuse, or unsafe dieting practices
* History of bariatric surgery, major medical conditions that prohibit physical activity or dietary intervention (MD consent may be required)

Primary outcomes:
measure: Gestational diabetes not present in pregnancy
timeFrame: from conception to delivery
Secondary outcomes:
Other outcomes:
Locations:
city: San Luis Obispo
country: United States
facility: Sierra Vista Regional Medical Center
state: California
Study officials:
affiliation: California Polytechnic State University-San Luis Obispo
name: Suzanne Phelan, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02526199: Protracted Mixture of Local Anesthetics for Major Foot and Ankle Surgery
Official title: Protracted Mixture of Local Anesthetics for Major Foot and Ankle Surgery. A Randomized Double-blind, Controlled Study Comparing Bupivacaine-Epinephrine 0.5% Versus Bupivacaine-Epinephrine 0.5% With Dexamethasone
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: Local anesthetics
Perineural nerve blocks
Perineurial Dexamethasone
Lead sponsor: Kolding Sygehus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2015-08-18
Enrollment: 56
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: To extend the duration of peripheral nerve blockade after major foot and ankle surgery the investigators randomize the postoperative treatment with either perineurial sciatic nerve blocks with 0.5% Bupivacaine-Epinephrine with or without Dexamethasone.


Eligibility criteria: Inclusion Criteria:

* age \> 17
* scheduled major foot and ankle surgery
* written informed consent
* fertile women in anti conceptive treatment
* fertile women not in anti conceptive treatment, but with negative urin-HCG on day of surgery

Exclusion Criteria:

* patients not able to understand or cooperate
* allergies to medicines involved
* daily buse of steroids
* daily use of opioids

Primary outcomes:
measure: Painfree period (time until first pain sensation in operated foot)
timeFrame: 48 hours
Secondary outcomes:
measure: Pain in the operated foot, measured on a numeric rating scale (0-10)
timeFrame: Every 30 minuttes from the patient enters the PACU to the nerve block wears of
measure: Sensibility score, measured with a hided tactile pinprick-sensation under the 3.rd toe on the operated foot
timeFrame: Every 30 minutes from the patient enters the PACU to the sensations core reach 2
measure: Total consumption of opioids during the length of stay
timeFrame: 48 hours
measure: quality of sleep first night measured on a 3 point scale
timeFrame: hours
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Anesthesia, Aarhus University Hospital
state: Region Midt
Study officials:
References: