louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00051116: A Phase II Study of Continuous Versus Syncopated Dosing of CC-5013 for the Treatment of Refractory Multiple Myeloma
Official title: A Phase II Study of Continuous Versus Syncopated Dosing of CC-5013 for the Treatment of Refractory Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: Multiple Myeloma
Revimid
CC5013
CC-5013
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2003-01-07
Enrollment: 100
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 evaluate the response rate, response duration, and survival of patients treated with CC-5013 in a chronic dosing schedule versus a syncopated dosing schedule.


Eligibility criteria: * History of histologically documented multiple myeloma with relapsed or resistant disease
* Pregnant or nursing women may not participate. Women of childbearing potential must have a negative pregnancy documented within one week of registration. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
* Signed written informed consent and willingness to meet follow-up schedule and study procedure obligations

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Myeloma Institute University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: Celgene Corporation
name: Robert Knight, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05789316: Head and Neck Cancer Survivorship Ototoxicity Screening (SOS)
Official title: Head and Neck Cancer Survivorship Ototoxicity Screening (SOS) Protocol
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer Survivors
Cancer of the Head and Neck Surviors
Keywords: survivorship
quality of life
cisplatin
radiation
head and neck cancer
hearing loss
ototoxicity
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: American Academy of Otolaryngology-Head and Neck Surgery Foundation
First posted: 2023-03-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: To evaluate the effectiveness, feasibility, acceptability, and appropriateness of an ototoxicity screening protocol among head and neck (H\&N) cancer patients followed in survivorship clinic that received cisplatin-based chemoradiation therapy (CRT).


Eligibility criteria: Inclusion Criteria:

* Adult (≥ 18 years old)
* H\&N cancer patients will be eligible for inclusion if they have previously undergone cisplatin-based CRT or radiotherapy, including proton therapy, intensity-modulated radiation therapy, and adaptive radiotherapy-surgery with curative intent (i.e., definitive, neoadjuvant, or adjuvant) or definitive surgery with neoadjuvant or adjuvant radiation.

Exclusion Criteria:

* Patient has been evaluated by an audiologist within the past 12 months
* Use of a hearing aid
* Received a cochlear implant
* Cannot complete simple forms in English

Primary outcomes:
measure: Rate of participants who complete audiologic follow-up
timeFrame: Through completion of follow-up (estimated to be 6 months)
Secondary outcomes:
measure: Feasibility of ototoxicity screening protocol as measured by the Feasibility of Intervention Measure
timeFrame: Before survivorship clinic visit (Day 1)
measure: Acceptability of ototoxicity screening protocol as measured by the Acceptability of Intervention Measure
timeFrame: Before survivorship clinic visit (Day 1)
measure: Appropriateness of ototoxicity screening protocol as measured by the Intervention Appropriateness Measure
timeFrame: Before survivorship clinic visit (Day 1)
measure: Functional hearing loss of participants as measured by the Situational Management Questionnaire (SESMQ)
timeFrame: After survivorship clinic visit (Day 1)
measure: Quality of life of participants as measured by the University of Washington Quality of Life Questionnaire (UW-QOL)
timeFrame: After survivorship clinic visit (Day 1)
measure: Functional social support as measured by the Duke-UNC Functional Social Support Questionnaire
timeFrame: After survivorship clinic visit (Day 1)
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: David Lee, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01677416: Joint Ultrasound Evaluation of Asymptomatic Rheumatic Feet
Official title: Joint Ultrasound Evaluation of Asymptomatic Feet in Patients With Rheumatoid Arthritis: A Controlled Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Ultrasonography
Synovitis
Foot joints
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2012-09-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rheumatoid Arthritis

Brief summary: Objectives: The aims of the present study were to compare ultrasound on asymptomatic feet of patients with rheumatoid arthritis (RA) and normal controls, determine the association between ultrasound and global disease activity, function and goniometric measures in patients with RA and determine the correlation between ultrasound and radiography in the detection of bone erosion.

Methods: The foot joints (talocrural, talocalcaneal, talonavicular, naviculocuneiform, calcaneocuboid, 5th tarsometatarsal and 1st to 5th metatarsophalangeal \[MTP\] joints) of 50 healthy subjects and 50 patients with RA (all with asymptomatic feet) were evaluated bilaterally regarding quantitative/semi-quantitative synovitis, semi-quantitative Power Doppler (PD) signals and erosion using ultrasound. Statistical significance was set to 5%.


Eligibility criteria: Inclusion Criteria:

Rheumatoid Arthritis Group:

* RA with at least one year since diagnosis
* Asymptomatic feet
* Age between 18 and 65 years Control group
* absence of known osteoarticular disease

Exclusion Criteria for both groups:

* Peripheral venous insufficiency with retrograde venous flow and/or ochre dermatitis
* Previous surgical intervention and/or fracture in feet/ankles
* Intra-articular corticosteroid injection in previous three months in any of the joints evaluated
* Foot neuropathy
* Pain and swelling in feet or ankles

Primary outcomes:
measure: Presence of synovial effusion and/or synovial hypertrophy
timeFrame: Baseline
measure: Presence of bone erosion
timeFrame: Baseline
Secondary outcomes:
measure: Radiographic evaluation
timeFrame: Baseline
measure: Intraobserver and interobserver agreement
timeFrame: Baseline
measure: Presence of synovial blood flow
timeFrame: Baseline
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Universidade Federal de Sao Paulo
state: SP - Sao Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Rita Furtado, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01526616: Spironolactone Plus Metformin in Polycystic Ovary Syndrome
Official title: Metformin Versus Metfotmin Plus Low-dose Spironolactone in the Treatment of Overweight/Obese Patients With Polycystic Ovary Syndrome: a Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: PCOS
metformin
spironolactone
metabolic syndrome
hyperandrogenism
Lead sponsor: University Magna Graecia
Sponsor class: OTHER
First posted: 2012-02-06
Enrollment: 56
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators examined whether a combined therapy with low-dose spironolactone plus metformin is more effective than metformin alone in 52 overweight/obese Polycystic Ovary Syndrome (PCOS) patients.

Detailed description: In the present prospective, randomized study, we evaluated the efficacy of a combined therapy with metformin and low-dose spironolactone as compared to metformin alone on the clinical and endocrine-metabolic alterations of PCOS patients.

Eligibility criteria: Inclusion Criteria:

* Overweight/obese patients with PCOS

Exclusion Criteria:

* Other causes of hyperandrogenism and
* Use of drugs including:

  * oral contraceptive
  * anti-hypertensive agents
  * anti-diabetic drugs
  * agents for weight loss

Primary outcomes:
measure: Metformin versus Metformin plus low-dose Spironolactone on metabolic parameters of Patients with Polycystic Ovary Syndrome: a randomized study
timeFrame: six months
Secondary outcomes:
measure: Spironolactone versus Metformin plus spironolactone in hyperandrogenism in Polycystic Ovary Syndrome
timeFrame: six months
Other outcomes:
Locations:
Study officials:
affiliation: Endocrinology Unit
name: A. Mazza B. Fruci A. Belfiore, Doctors
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mazza A, Fruci B, Guzzi P, D'Orrico B, Malaguarnera R, Veltri P, Fava A, Belfiore A. In PCOS patients the addition of low-dose spironolactone induces a more marked reduction of clinical and biochemical hyperandrogenism than metformin alone. Nutr Metab Cardiovasc Dis. 2014 Feb;24(2):132-9. doi: 10.1016/j.numecd.2013.04.016. Epub 2013 Jul 8.
Clinical trial NCT00321516: Drug-drug Interaction Study of Aripiprazole and Lamotrigine in Patients With Bipolar Type I Disorder
Official title: Effects of Aripiprazole on the Steady-State Pharmacokinetics of Lamotrigine in Subjects With Bipolar I Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bipolar Disorder
Keywords: Bipolar type I Disorder
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2006-05-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this clinical research study is to learn if aripiprazole has a drug-drug interaction with lamotrigine.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) of 18 to 40 kg/m2
* Subjects with bipolar I disorder who are clinically stable on a stable dose of at least 100 mg lamotrigine for at least 4 weeks prior to study entry
* Men and women, ages 18 to 65

Exclusion Criteria:

* Women who are pregnant or breastfeeding
* Patients with any significant acute or chronic medical illness, other than bipolar I disorder
* Subjects with active psychotic symptoms
* History of head trauma within the past 2 years
* History of akathisia requiring treatment
* History of tardive dyskinesia or abnormal involuntary movements
* Subjects with a predisposition to orthostatic hypotension
* Positive urine screen for drugs of abuse
* Use of narcotic-containing agents, amphetamines, or hormonal contraceptives within 4 weeks of study start

Primary outcomes:
measure: Comparison of Cmax (maximum drug concentration) and AUC(Tau) (exposure) of lamotrigine at the beginning of the study (Day-1) and when the subject completes the study (Day 36)
Secondary outcomes:
measure: Assess the safety and tolerability of aripiprazole when co-administered with lamotrigine for up to 4 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Austin
country: United States
facility: Local Institution
state: Texas
city: Bellaire
country: United States
facility: Local Institution
state: Texas
city: Desota
country: United States
facility: Local Institution
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00568516: Phase II Study of ASP3550 in Patients With Prostate Cancer
Official title: Phase II Study of ASP3550 - A Maintenance-dose Finding Study in Patients With Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Keywords: ASP3550
Degarelix
Prostate cancer
Prostatic neoplasms
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2007-12-06
Enrollment: 273
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the effect of ASP3550 on the maintenance of serum testosterone suppression in patients with prostate cancer

Detailed description: Two doses of ASP3550 were administered to patients with prostate cancer. The primary efficacy variable was the effect of ASP3550 on the maintenance of serum testosterone suppression. In addition, the safety and pharmacokinetics of ASP3550 will be investigated.

Eligibility criteria: Inclusion Criteria:

* Is a male patient with histologically proven prostate cancer (adenocarcinoma) of all stages
* Is a patient in whom endocrine treatment is indicated. Patients with rising serum PSA after having prostatectomy or radiotherapy performed with curative intention may be included
* Has a serum testosterone level above 1.5 ng/mL at screening
* Has an ECOG (Eastern Co-operative Oncology Group) P.S. (Performance Status) score of 0 to 2

Exclusion Criteria:

* Previous or present endocrine treatment for prostate cancer. However, patients who have undergone neoadjuvant/adjuvant endocrine therapy for a maximal duration of 6 months and in whom prostatectomy or radiotherapy was terminated at least 6 months preceding Screening Visit may be included
* Is being treated with a 5α-reductase inhibitor
* Is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months
* Has concurrent or a history of severe asthma (defined as a need for daily treatment with inhalation steroids), anaphylactic reactions, severe urticaria and angioedema

Primary outcomes:
measure: Proportion of patients with serum testosterone ≤0.5 ng/mL from Day 28 to Day 364 of treatment
timeFrame: 1 Year
Secondary outcomes:
measure: Proportion of patients with testosterone surge
timeFrame: 1 Year
measure: Percentage change in serum PSA
timeFrame: 1 Year
measure: Changes in serum levels of testosterone, LH, FSH and PSA over time
timeFrame: 1 Year
measure: Time to the recurrence of serum PSA
timeFrame: 1 Year
Other outcomes:
Locations:
city: Chubu
country: Japan
city: Chugoku
country: Japan
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kanto
country: Japan
city: Kyusyu
country: Japan
city: Shikoku
country: Japan
city: Tohoku
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT05533216: Upper Limb Functional Testing in Athletes
Official title: Upper Limb Functional Testing in Athletes: Elaboration of Normative Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Functional Performance
Keywords: prevention
performance
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 587
Sex: ALL
Minimum age (years): 14
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The participants will have to practice an upper limb sport for, at least, 3 years and with a volume of at least 5-6 hours a week.

Brief summary: The aim of this study is to elaborate sports-specific normative data for different upper limb functional tests.

About 250 sportspeople, aged between 14 and 35 years, and practicing an upper limb sport, will be recruited. They will performed some of the following tests, based on the sport they practice :

* Upper Quarter Y Balance Test
* Athletic Shoulder Test
* Single Arm Medicine Ball Throw
* Countermovement push-ups
* Closed Kinetic Chain Upper Extremity Stability Test
* Upper Limb Rotation Test
* Posterior Shoulder Endurance Test
* Seated Shot Put Test


Eligibility criteria: Inclusion Criteria:

* To practice an upper limb sport, at least 5 or 6 hours a week

Exclusion Criteria:

* Shoulder pain, injury or surgery during the last 6 months

Primary outcomes:
measure: Score Upper Quarter Y Balance Test
timeFrame: through study completion
measure: Athletic Shoulder Test
timeFrame: through study completion
measure: Single Arm Medicine Ball Throw
timeFrame: through study completion
measure: Closed Kinetic Chain Upper Extremity Stability Test
timeFrame: through study completion
measure: Upper Limb Rotation Test
timeFrame: a single measurement
measure: Posterior Shoulder Endurance Test
timeFrame: through study completion
measure: Seated Single Arm Shot Put Test
timeFrame: through study completion
measure: Shoulder rotators isometric strength
timeFrame: through study completion
Secondary outcomes:
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: University of Liège
state: Liège
Study officials:
affiliation: University of Liege
name: Camille Tooth
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04797416: The Evaluation of Consistency by Finger Stick Blood Glucose or Venous Blood Glucose of Flash Glucose Monitoring in Different Infiltration Time
Official title: The Evaluation of Consistency by Finger Stick Blood Glucose or Venous Blood Glucose of Flash Glucose Monitoring in Different Infiltration Time
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Flash Glucose Monitoring
Conscience
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2021-03-15
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This is a prospective randomized controlled study to evaluate consistency by finger stick blood glucose or venous blood glucose in different infiltration time (including the time between activation of the sensor and storage of the first blood glucose value) of Flash glucose monitoring(FGM). In this study, the relationship between the dynamic blood glucose and finger stick blood glucose or venous blood glucose in type 2 diabetes mellitus patients(T2DM), was explored. And the investigators also analyzed the deviation and accuracy of FGM in practical application,so as to provide a good reference for clinical application.


Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes fit the 1999 who diagnostic criteria for diabetes
* Aged 18 or above
* Without serious complications, such as diabetic ketoacidosis, severe infection,severe cardiac insufficiency, severe liver and kidney diseases
* Voluntary and signed informed consent to participate
* Be able to read and understand Chinese, perform all research visits and tasks, and follow research instructions

Exclusion Criteria:

* Patients with known allergy to medical grade adhesive or isopropanol used for skin disinfection, edema, skin damage, scar, redness, infection, etc. during pregnancy or preparation of pregnancy or at the sensor application site (dorsal side of upper arm).
* The examinee took drugs such as ascorbic acid (vitamin C) and salicylic acid (an ingredient in aspirin and many painkillers) that affected the accuracy of the sensor.
* MRI is required during the study.
* The examinee had poor compliance and could not continue to complete the study.

Primary outcomes:
measure: Difference value
timeFrame: Up to 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: endocrinology department of the first affiliated hospital of Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT06456216: Performance Evaluation of Diagnostic Accuracy of PanTum Detect Test for Detection of Solid Tumours in Known Cancer Population and in Cancer Free Population.
Official title: Performance Evaluation of Diagnostic Accuracy (Sensitivity and Specificity) of PanTum Detect Test for Detection of Solid Tumours in Known Cancer Population (Sick Population) and in Cancer Free (Healthy) Population.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Solid Tumor
Lead sponsor: Max Healthcare Insititute Limited
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: this evaluation study will be done in 3 groups of 60 subjects each using 3 differents lots of pantum detect test kit. each group will have an equal population of patients with primary tomur disease( the sick population) and healthy populations.

Brief summary: Performance evaluation of diagnostic accuracy (Sensitivity and Specificity) of PanTum detect Test for detection of solid tumours in known cancer population (Sick population) and in cancer free (Healthy) population.

Detailed description: PanTum Detect is a simple blood test that can detect presence of solid tumors using two important tumor biomarkers - Apo 10 and TKTL-1. Most tumors develop slowly and gradually. From the first tumor cell, to the identification of the tumor itself, there can be a timespan of many years. The turning point where a locally growing tumor develops into an invasive, metastasizing cancer is paramount for curability. It is the objective of PanTum Detect to detect a tumor in time before this critical turning point. Such locally growing tumors can often easily be removed by surgery or treated successfully

Eligibility criteria: Inclusion Criteria:

1. written informed consent
2. sick population with hiostopathology proven diagnosis
3. age 30-75 years
4. newly diagnosed case of solid tumor.

Exclusion Criteria:

1. history of past surgery within 8 weeks.
2. history of any chemotherapy, vaccination etc

Primary outcomes:
measure: Performance evaluation of diagnostic accuracy (Sensitivity and Specificity) of PanTum detect Test for detection of solid tumours in known cancer population (Sick population) and in cancer free (Healthy) population.
timeFrame: 1 YEAR
Secondary outcomes:
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Max Super Speciality Hospital, A Unit of Devki Devi Foundation
Study officials:
affiliation: Max Super Speciality Hospital, Saket
name: Harit Chaturvedi, MCH
role: PRINCIPAL_INVESTIGATOR
References: