louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02927756: Italian Multicenter Retrospective Observational Study on Transformed Lymphomas
Official title: Italian Multicenter Retrospective Observational Study on Transformed Lymphomas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Non-Hodgkin Lymphoma Transformed Recurrent
Keywords: Non-Hodgkin Lymphoma Transformed Recurrent
Discordant Lymphomas
Composite Lymphomas
Follicular Lymphoma
Aggressive Lymphoma
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
First posted: 2016-10-07
Enrollment: 180
Sex: ALL
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: Adult patient with histologically confirmed diagnosis of Transformed Follicular Lymphoma

Brief summary: Study purpose is to evaluate treatment outcome and survival in patient with aggressive lymphomas transformed from Follicular Lymphoma.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed transformed Follicular Lymphoma
* Age \> 18 years
* Histological transformation between January 2002 and December 2014
* Availability of data about treatment and outcome

Exclusion Criteria:

* Other lymphoma diagnosis

Primary outcomes:
measure: Progression Free Survival
timeFrame: From first response to last follow-up for at least 2 years (up to 15 years)
measure: Overall Survival
timeFrame: Date of last follow-up for at least 2 years (up to 15 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Torino
country: Italy
facility: SC Ematologia - AOU Città della Salute e della Scienza di Torino
Study officials:
affiliation: A.O.U. Città della Salute e della Scienza
name: Barbara Botto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02532556: Electrical Stimulation of the Muscle Pumps of the Leg
Official title: Electrical Stimulation of the Muscle Pumps of the Leg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Haemodynamic Physiology
Keywords: Haemodynamic physiology
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2015-08-25
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The most efficient way of electrically stimulating the calf muscles has not been identified. The investigators aim to investigate this using a matrix of electrical parameters, and measuring the outcome with vascular ultrasound of the leg.

Detailed description: Blood is aided on its journey to the heart by the action of the muscles of the legs. Muscle contraction squeezes the deep veins of the leg and pushes blood upwards, back towards the heart. In immobilised patients, or those with blood vessel problems, the pumping process can be helped by machines that either squeeze or shock the muscles of the calf (e.g. intermittent pneumatic compression, electrical stimulating devices). Many are licensed for medical use, and some are common place in hospitals and outpatient departments.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Current good health

Exclusion Criteria:

* History of cardiovascular disease
* Ankle Brachial Pressure Index \<0.9
* Venous reflux\>0.5s
* Pregnancy

Primary outcomes:
measure: Venous Haemodynamic Measurements (Volume Flow Rate)
timeFrame: Baseline compared to that after 10-mins stimulation (2-mins to take measurements)
measure: Venous Haemodynamic Measurements (Time Averaged Maximum Velocity)
timeFrame: Baseline compared to that after 10-mins stimulation (2-mins to take measurements)
Secondary outcomes:
measure: Pain Grading on Stimulation
timeFrame: During stimulation (10-mins each muscle)
Other outcomes:
Locations:
Study officials:
affiliation: Imperial College London
name: Alun Davies
role: PRINCIPAL_INVESTIGATOR
References:
citation: Evans DR, Williams KJ, Strutton PH, Davies AH. The comparative hemodynamic efficacy of lower limb muscles using transcutaneous electrical stimulation. J Vasc Surg Venous Lymphat Disord. 2016 Apr;4(2):206-14. doi: 10.1016/j.jvsv.2015.10.009. Epub 2016 Jan 12.
Clinical trial NCT01969656: Safety Study of an Oral Vitamin D Analog in Postmenopausal Women
Official title: A Phase 1B, Double-Blind, Placebo-Controlled, Calcitriol Active-Controlled, Daily-Dose, Escalating-Dose, Safety and Tolerance Study of 2MD Soft Gel Capsules in Normal Healthy Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Postmenopausal Osteoporosis, Multiple Sites
Keywords: vitamin D analog
Lead sponsor: Deltanoid Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-10-25
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT

Brief summary: Determine the safety of 2MD, a vitamin D analog, when administered orally once daily for 28 days in healthy normal postmenopausal women.


Eligibility criteria: Inclusion Criteria:

1. Normal healthy postmenopausal women, ≥ 60 but ≤ 80 years of age, or between 45 and 60 years of age who have been amenorrheic for at least 2 years plus have a serum FSH level of \> 30 IU/L, or women with a documented bilateral oophorectomy at least 2 years prior to study start.
2. Within ±30% of their ideal body weight for height and body frame.
3. Demonstrated ability to understand and willingness to sign an Informed Consent Form.
4. 24-hour urinary Ca ≤250 mg/day and a urinary Ca:Cr ≤0.35.
5. Negative urine test for selected drugs of abuse.
6. Willing to maintain a total calcium intake between 700 and 1000 mg/day.

Exclusion Criteria:

1. Any acute or chronic condition that would limit the subject's ability to complete the study.
2. Active clinical manifestations of significant metabolic, hematological, pulmonary, hepatic, cardiovascular, gastrointestinal (including malabsorption), neurological, renal, urological or psychiatric disorders.
3. History or presence of any diseases known or believed to influence calcium absorption or metabolism.
4. History of renal calculi.
5. History of an eating disorder.
6. History of stomach or intestinal surgery.
7. History of hypersensitivity or allergies to any vitamin D derivative.
8. History or presence of an abnormal ECG.
9. Use of any medications or products affecting vitamin D metabolism within 6 months prior to study entry.
10. Use of any medications or products affecting calcium balance or bone turnover within 6 months prior to study entry.
11. Participation in any other investigational study drug trial in which receipt of investigational study drug occurred within 60 days prior to study entry.
12. Use of vitamin and/or mineral supplements \>1X RDI within 4 weeks prior to study entry, unless deemed acceptable by Investigator.
13. Poor peripheral venous access.
14. Receipt of blood products within 2 months prior to study entry.

    -

Primary outcomes:
measure: Change from baseline in total serum calcium
timeFrame: Days 0 (pre-dose), 1, 2, 3, 7, 14, 21, 27, 28 and 2 weeks after last dose
measure: Change from baseline in levels of 2MD in the blood
timeFrame: 1, 2, 3, 12, 18 and 24 h after the initial dose on Day 0 and after the final dose on Day 27
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05828056: Prediction on the Recurrence of Manic and Depressive Episodes in Bipolar Disorder
Official title: Prediction on the Recurrence of Manic and Depressive Episodes in Bipolar Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bipolar Disorder
Depressive Disorder
Keywords: biomarker
Bipolar disorder
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-04-25
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will recruit 100 patients with mood disorders from the psychiatric ward and outpatient services of the Department of Psychiatry, National Taiwan University Hospital. All the participants will be followed for one year to collect the daily activity level, sleep patterns, heart rate through actigraphy, as well as location, mood report, drug compliance and face photo through smartphone app that will be developed by Co-PI Lai.

Brief summary: Mood disorders (including bipolar disorder and major depressive disorder) are chronic mental disorders with high recurrent rate. The more the number of recurrence is, the worse long-term prognosis is. This study aims to establish a prediction model of recurrence of manic and depressive episodes in mood disorders, with a hope to detect recurrence relapse as early as possible for timely clinical intervention. We will adopt wearable smart watch to collect heart rate, sleep pattern, activity level, as well as emotional status for one year long in 100 patients with bipolar disorder, and annotated their mood status (i.e., manic episode, depressive episode, and euthymic state). We expect to establish prediction models to predict the recurrence of mood episodes.


Eligibility criteria: Inclusion Criteria:

* DSM-5 Bipolar disorder or depressive disorder
* 20\~60 years old
* Willing to carry smartwatch and smartphone most of the time

Exclusion Criteria:

* Comorbid with substance use disorder
* Unable to use smartwatch and smartphone

Primary outcomes:
measure: Development and verification of mood episode prediction algorithm
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
References:
Clinical trial NCT00244556: Study Comparing Enbrel (Etanercept) Plus Methotrexate Versus Enbrel Alone in Active Rheumatoid Arthritis Despite Current Methotrexate Therapy
Official title: A Randomized Comparison of the Safety and Efficacy of Enbrel (Etanercept) Plus Methotrexate Versus Enbrel Alone in Patients With Active Rheumatoid Arthritis Despite Current Methotrexate Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-26
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the changes in MRI-derived markers of joint inflammation and destruction and in biochemical markers of connective tissue metabolism and angiogenesis in rheumatoid arthritis patients treated with Enbrel and Enbrel+methotrexate.


Eligibility criteria: Inclusion Criteria:

* In the case of contra-indications for MRI, the patient may participate in the remaining part of the project.

Exclusion Criteria:

* N/A

Primary outcomes:
measure: To assess the efficacy and safety of substituting ENBREL versus adding ENBREL to Methotrexate in patients with active Rheumatoid Arthritis despite adequate Methotrexate therapy.
Secondary outcomes:
measure: To evaluate the effect of combination therapy with ENBREL plus Methotrexate versus ENBREL alone on health-related quality of life measures.
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03317756: CONfident Treatment Decisions in Living With Rheumatoid Arthritis
Official title: CONfident Treatment Decisions in Living With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Pfizer Independent Grants for Learning and Change
First posted: 2017-10-23
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Pilot test the novel educational patient-directed intervention to demonstrate the feasibility of the novel educational approaches developed in improving patient's willingness to achieve remission or low disease activity in RA.

Detailed description: Pilot test the novel educational patient-directed intervention to demonstrate the feasibility of the novel educational approaches developed in improving patient's willingness to achieve remission or low disease activity in RA. Upon agreement to participate, the patient participants will provide information on their treating physician. This information will be used to invite physicians to complete the physician-educational intervention and offered CME credits for completing the activity.

The investigators will recruit participants from a patient registry (1:1 intervention: control) that meet the eligibility criteria. The recruited patients will complete the educational intervention (if randomized to the intervention arm) and the study outcomes will be collected immediately after the intervention and also after the patients most proximate rheumatologist visit (up to 6-months later).

Eligibility criteria: Inclusion Criteria:

* Have a patient-reported diagnosis of RA
* Most recent RAPID3 \> 12 collected in the last 6 months
* Have not changed RA medication in the last 6 months
* Taking medications that are commonly used in RA (e.g. methotrexate, sulfasalazine, hydroxychloroquine (plaquenil), leflunomide (arava), etanercept (enbrel), adalimumab (Humira), tofacitinib (xeljanz), actemra (tocilizumab), sarilumab (Kevzara) , infliximab (remicade), golimumab (Simponi), rituximab (rituxan), abatacept (Orencia), and certolizumab (Cimzia))

Exclusion Criteria:

* Does not meet inclusion criteria
* Age \< 18

Primary outcomes:
measure: Patient willingness to adopt T2T and the attainment of the T2T goals.
timeFrame: Follow-up Survey #1 (after completion of the intervention)
Secondary outcomes:
Other outcomes:
measure: Acceptability of the educational interventions
timeFrame: Follow up Survey #1 (after completion of intervention)
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Maria I Danila, MD MSc MSPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00475956: Safety and Tolerability Study of AZD2171 in Combination With AZD0530 in Patients With Advanced Solid Tumours
Official title: Phase I, Open-Label Study To Assess the Safety, Tolerability and Pharmacokinetics of Daily Oral Doses of Cediranib (RECENTIN™;AZD2171) (20, 30 or 45mg) When Co-Administered With Daily Oral Doses of AZD0530 (125mg or 175mg) in Patients With Advanced Solid Tumours
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: Cancer
Tumour
Advanced Solid Tumour
Lung Cancer
Breast Cancer
Cholangiocarcinoma
Colon Cancer
Gastric Cancer
Choriocarcinoma
Liver Cancer
Myeloma
Ovarian Cancer
Pancreatic Cancer
Peritoneal Cancer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-05-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine if the maximum tolerated doses of AZD2171, in combination with AZD0530, in treating patients with advanced solid tumours are safe, tolerable and efficacious.


Eligibility criteria: Inclusion Criteria:

* Written consent
* Cancer diagnosis \& stage
* Patients for whom no standard therapy exists
* World Health Organization (WHO) performance status 0-2
* One or more measurable lesions

Exclusion Criteria:

* Prostate cancer
* Untreated unstable brain or meningeal metastases
* Specific laboratory ranges
* Pregnant or breast-feeding women
* Any evidence of severe or uncontrolled diseases
* Participation in other trials within 30 days

Primary outcomes:
measure: Determine the safety and tolerability of ascending daily oral doses of AZD2171 when co-administered with AZD0530 to patients with advanced solid tumours by assessment of AEs, vital signs, HRCT Scans, clin chem, haematology, urinalysis, ECG and phys exam
timeFrame: assessed at each visit
Secondary outcomes:
measure: Pharmacokinetics (PK) of AZD2171 alone and in combination with AZD0530
timeFrame: assessed at each visit
measure: Safety and efficacy
timeFrame: assessed at each visit
measure: Genetic variation of pathways targeted by AZD2171 and AZD0530
timeFrame: assessed during study
Other outcomes:
Locations:
city: Freiburg
country: Germany
facility: Research Site
state: Baden-Wurttemberg
city: Essen
country: Germany
facility: Research Site
state: Ruhr
city: Herne
country: Germany
facility: Research Site
state: Ruhr
Study officials:
affiliation: AstraZeneca
name: Jane Roberston
role: STUDY_DIRECTOR
affiliation: Universitatsklinikum der GHS Essen
name: Tanja Trarbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05050656: Oral Duloxetine as a Premedication for Postoperative Pain Control
Official title: "Preoperative Oral Duloxetine: Does it Affect Duration of Spinal Anesthesia and Early Postoperative Pain After Arthroscopic ACL Repair?" a Prospective, Randomized, Double-blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anesthesia
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-09-20
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of the study is to use duloxetine as premedication in Anterior cruciate ligament repair under spinal anesthesia and evaluate the effect on onset and duration of spinal anesthesia and postoperative pain control.

Detailed description: We designed this randomized, double-blind study to evaluate the effectiveness of administration of oral duloxetine 2 hours preoperatively on the onset and the duration of the spinal anesthesia in arthroscopic anterior cruciate ligament (ACL) repair and the role of duloxetine on postoperative analgesia.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists I or II.
* Sex: Both sexes.
* Age between 18 and 50.
* Height 155-180 cm.
* Patients scheduled for arthroscopic anterior cruciate ligament (ACL) repair under spinal anesthesia.

Exclusion Criteria:

* Declining to give written informed consent.
* History of allergy to the medications used in the study.
* Had a history of drug or alcohol abuse.
* Taking opioids or sedative medications.
* Inability to communicate with patients to evaluate the postoperative pain.
* Need for postoperative ICU hospitalization.
* Hepatic or renal failure.
* Patients with a history of taking duloxetine or any SSRIs.
* Contraindications to regional anesthesia (including coagulopathy and local infection).
* Psychiatric disorders with antipsycotics or antidepressants (tricylic or MAOIs).
* Antiplatelets (aspirin, clopidogrel) or anticoagulant (warfarin).
* Quinolones (ciprofloxacin).

Primary outcomes:
measure: Assess the onset of spinal anesthesia
timeFrame: 20 min
Secondary outcomes:
measure: Duration of spinal anesthesia
timeFrame: 4 hours
measure: Postoperative pain
timeFrame: 24 hours
measure: Time for first postoperative rescue analgesia request, frequency, and total morphine consumption
timeFrame: 24 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of medicine, Ain Shams University
Study officials:
affiliation: Faculty of medicine, Ain Shams University, Cairo, Egypt
name: tamer abdelaziz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00353756: Phase 1 Study of Safety and Biological Effects of C326, an Inhibitor of IL-6, in Crohn's Disease
Official title: A Placebo-Controlled, Phase 1, Single and Multiple IV Dose Escalation Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of C326 in Adults With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Crohn's Disease
Lead sponsor: Avidia
Sponsor class: INDUSTRY
First posted: 2006-07-19
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether C326, a new inhibitor of IL-6, is safe in patients with Crohn's disease.

Detailed description: Determination of safety is the most important goal of this first study with C326. Other goals of the study are to examine:

* pharmacokinetics (change in serum concentrations over time),
* biological activity (change in blood markers relecting activity of Crohn's Disease),
* effects on symptoms of Crohn's disease.

Participants may receive either a single or several intravenous infusions of C326 or matching placebo.

Eligibility criteria: Inclusion Criteria:

* Adults 18 - 65
* Stable, moderately active Crohn's Disease
* Otherwise in generally good health

Exclusion Criteria:

* Variety of concurrent medical conditions
* Various concomitant medications

Primary outcomes:
measure: Safety evaluations
Secondary outcomes:
measure: Pharmacokinetics
measure: Biomarker changes -- IL-6, CRP and other acute phase reactants
measure: Crohn's Disease Activity Index (CDAI)
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: QPharm
state: Queensland
city: Melbourne
country: Australia
facility: Center for Clinical Studies
state: Victoria
Study officials:
affiliation: Alfred Hospital, Melbourne, Australia
name: Lee Min Yap, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Brisbane and Womens Hospital, Brisbane, Australia
name: Graham Radford-Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: