louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00220389: Two Phase Extension Trial of SP668 to Investigate the Safety and Tolerability of Sustained Release Fesoterodine in Subjects With Overactive Bladder: a Double-Blind Phase Followed by an Open-Label Extension Phase
Official title: Two Phase Extension Trial of SP668 to Investigate the Safety and Tolerability of Sustained Release Fesoterodine in Subjects With Overactive Bladder(OAB): a Double-Blind Phase Followed by an Open-Label Extension Phase
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Overactive Bladder
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This extension trial of SP668 consists of two phases: double-blind treatment and open-label extension. The trial provides subjects the option of long-term treatment with sustained release (SR) fesoterodine (SPM 907) and to assess long-term subject safety, tolerability and efficacy.

Double-Blind: Subjects remained on either fesoterodine 4mg, 8mg or 12mg depending on their dose assignment in SP668. Previous SP668 placebo subjects received fesoterodine 4mg.

Open-Label: Subjects received fesoterodine 8mg with a one time option to reduce the dose to 4mg and a one time option to increase again to 8mg.

The primary variables focus on long-term safety and tolerability and include the observation and assessment of adverse events, residual urinary volumes, laboratory parameters, changes in ECG, physical and urological examinations and subject's assessment of treatment tolerance.

Secondary efficacy variables include various parameters derived from micturition diaries, count of subjects and their dose choice throughout the trial and subject's assessment of treatment efficacy.


Eligibility criteria: Inclusion Criteria:

* Overactive bladder

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: RTP
country: United States
facility: Schwarz
state: North Carolina
Study officials:
affiliation: UCB Pharma
name: Brooke Derby
role: STUDY_DIRECTOR
References:
Clinical trial NCT02572089: Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers
Official title: Phase 1, Pharmacokinetic Evaluation of Intranasal and Intramuscular Naloxone in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Drug Overdose
Opioid-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: Vince & Associates Clinical Research, Inc.
First posted: 2015-10-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To determine the pharmacokinetics of 4 intranasal doses of naloxone compared to a 0.4 mg dose of naloxone administrated intramuscular and to identify an appropriate intranasal dose that could achieve systemic exposure comparable to an approved parenteral dose. To also determine the pharmacokinetics of two different concentrations of intranasal naloxone and finally, to determine the safety of intranasal naloxone with respect to nasal irritation.


Eligibility criteria: Inclusion Criteria:

* Be able to provide written consent
* Must have a BMI ranging from 18 to 30kg/m2, inclusive
* Must have adequate venous access
* Must not have any clinically significant concurrent medical conditions determine by medical history, physical examination, vital signs, and 12-lead electrocardiogram.
* Must agree to use a reliable double-barrier method of birth control from the start of screening until one week after completing the study. Oral contraceptives are prohibited.
* Must agree to not ingest alcohol, drinks containing xanthine greater than 500 mg/day (e.g., Coca Cola, coffee, tea, etc.), or grapefruit/grapefruit juice or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study.

Exclusion Criteria:

* Please contact clinical site directly for more information

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: 720 minutes
measure: Time at Maximum Plasma Concentration (Tmax)
timeFrame: 720 minutes
measure: Area Under the Concentration (AUC 0-t)
timeFrame: 720 minutes
measure: Area Under Curve (AUC 0-inf)
timeFrame: 720 minutes
measure: Half-life
timeFrame: 720 minutes
Secondary outcomes:
measure: Adverse events
timeFrame: minimum of 18 days
measure: Vital Signs
timeFrame: 480 minutes
measure: 12-lead electrocardiogram
timeFrame: 480 minutes
measure: Nasal Irritation Scoring
timeFrame: 24 hours
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Vince Associates Clinical Research
state: Kansas
Study officials:
References:
Clinical trial NCT01204489: Lifestyle Intervention for Toddlers Pilot Study
Official title: Lifestyle Intervention for Toddlers at Finnish Welfare Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Finnish Institute for Health and Welfare
Sponsor class: OTHER_GOV
Collaborators: name: Tampere University
name: University of Helsinki
name: The Finnish Hearth Association
name: The Finnish Food Information
First posted: 2010-09-17
Enrollment: 148
Sex: ALL
Minimum age (years): 6
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Study aims to pilot a family-centred tailored nutrition intervention at child welfare clinics, targeting the previously observed dietary defaults of Finnish children.

Detailed description: Eating habits can predict diet-related health problems and obesity. The defaults observed previously in the diet of Finnish children include low consumption of vegetables, fruits and vegetable oil-based fats, high consumption of sucrose, poor quality of drinks and low frequency of family meals. Child welfare clinic is the place to promote healthy lifestyles because most Finnish families visit there at regular intervals.

Eligibility criteria: Inclusion Criteria:

* all families at their child's standard 6-month child welfare clinic visit

Exclusion Criteria:

* families with twins
* families who do not speak Finnish

Primary outcomes:
measure: To promote child's and family's healthy diet
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Child welfare clinics
state: Uusimaa
Study officials:
affiliation: Head of the Nutrition Unit, professor
name: Suvi M Virtanen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05727189: A Study of Idazoxan in Healthy Participants
Official title: A Phase 1 Safety, Tolerability and Pharmacokinetic Study of R-Idazoxan HCl Extended-Release (TR-01-XRR), S-Idazoxan HCl Extended-Release (TR-01-XRS) and Racemic Idazoxan HCl Extended-Release (TR-01-XR) in Healthy Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Terran Biosciences Australia Pty Ltd
Sponsor class: INDUSTRY
First posted: 2023-02-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Part 1: Parallel group comparison, single dose level of 5 forms of the investigational study drug.

Part 2: Parallel group comparison, single dose escalation (3 dose levels) of 4 forms investigational study drug and placebo.

Part 3: Placebo controlled, multiple dose cross-over within 4 parallel group comparison.

Part 4: Single-dose food effect cross-over.
Primary purpose: TREATMENT

Brief summary: Four-part study of the safety, tolerability and pharmacokinetics of 3 forms of TR-01-XRR, 1 form of TR-01-XRS, and 1 form of TR-01-XR in healthy adults.


Eligibility criteria: Inclusion Criteria:

* BMI between 18 and 32 kg/m2
* Medically healthy without clinically significant or relevant medical history

Exclusion Criteria:

* Evidence of recurrent disease, physical illness or medical condition that could affect action, absorption or disposition of investigational products
* Use of any prescription or over-the-counter medication that cannot be discontinued for the duration of the study
* Impaired renal function
* Cardiac abnormalities
* Positive HIV, HBsAg or HCV
* Positive test for alcohol, drugs of abuse or cotinine

Primary outcomes:
measure: Number of participants with treatment-related adverse events based on clinical observation and participant report
timeFrame: Through study completion up to 25 days after initial dose
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: Up to 120 hours after dose
measure: Maximum plasma concentration (Cmax)
timeFrame: Up to 120 hours after dose
measure: Time to maximum plasma concentration (Tmax)
timeFrame: Up to 120 hours after dose
measure: Terminal elimination rate constant
timeFrame: Up to 120 hours after dose
measure: Terminal elimination half-life (T1/2)
timeFrame: Up to 120 hours after dose
measure: Apparent total clearance from plasma (CL/F)
timeFrame: Up to 120 hours after dose
measure: Apparent volume of distribution (Vz/F)
timeFrame: Up to 120 hours after dose
Secondary outcomes:
measure: Relative bioavailability (Frel)
timeFrame: Over 120 hours after dose
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: Scientia Clinical Research
state: New South Wales
city: Adelaide
country: Australia
facility: CMAX Clinical Research
state: South Australia
Study officials:
affiliation: Clinical Lead Consultant
name: Robert Fishman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05178589: The Role of Transcutaneous Electrical Nerve Stimulation (TENS) for Menstrual Pain Relief
Official title: The Role of Transcutaneous Electrical Nerve Stimulation (TENS) for Menstrual Pain Relief: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2022-01-05
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This is a randomized cross-over design over the course of 3 menstrual cycles. Each menstruation phase begins on the first day of menstruation until the last day of menstruation (disappearance of bleeding). Each participant will participate in 3 randomized conditions: control (no TENS), one-unit TENS, and two-unit TENS.
Primary purpose: TREATMENT

Brief summary: The present study aims to verify the analgesic potential of a transcutaneous electrical nerve stimulation (TENS) device using patients with primary dysmenorrhea and compare it with a control period without usage.


Eligibility criteria: Inclusion Criteria:

* History of lower abdominal pain (dysmenorrhea) for more than 6 consecutive menstrual cycles with a moderate or severe pain rating ≥5 out of 10 over course of last year
* BMI of 18.5-29.9 as a BMI below or above these cut points results in highly varied menstrual cycle lengths
* Not taking contraception or other types of medication that could influence reproductive status
* Regular menstruation
* Medically free from chronic diseases
* Free from known gynecological problems (ie. Endometriosis, Fibroids, Ovarian Cysts)
* History of analgesic pill intake during menstruation
* No pelvic pathology

Exclusion Criteria:

* Amenorrhea
* On a form of contraception
* Secondary dysmenorrhea and/or other gynecological problems that may cause pain
* No discomfort, pain, or other symptoms during menstruation
* History of surgery over lower abdomen area
* Allergy to ibuprofen
* Cardiac disability
* Pacemaker
* Arterial disease
* Uncontrolled hemorrhage
* Blood clots
* Pregnancy or trying to become pregnant
* Cancerous lesions
* Exposed metal implants
* History of seizures
* Sensory or mental impairment
* Unstable fractures

Primary outcomes:
measure: Analgesic effects of TENS on primary dysmenorrhea.
timeFrame: 1 month
Secondary outcomes:
measure: Change in analgesic pill consumption during menstruation
timeFrame: 1 month
Other outcomes:
measure: The surface area of TENS pain relief
timeFrame: 1 month
Locations:
city: Los Angeles
country: United States
facility: University of Southern California Health Sciences Campus Center for Health Professions
state: California
Study officials:
affiliation: Associated Professor
name: Todd Schroeder, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06078189: Rhizarthrosis Surgery and Functional Recovery: Arthroplasty vs. Trapezectomy
Official title: Comparing Short-Term Functional Recovery After Surgery for Rhizarthrosis: Arthroplasty vs. Trapezectomy - A Prospective Randomized Evaluation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rhizarthrosis
Keywords: osteoarthritis - Trapezectomy
Lead sponsor: Clinique Bizet
Sponsor class: OTHER
First posted: 2023-10-11
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with symptomatic disabling osteoarthritis in failure of medical treatment

Brief summary: Rhizarthrosis is a form of osteoarthritis that affects the trapeziometacarpal joint at the base of the thumb, which is more common in women over 50. Genetic and hormonal factors as well as the frequency of certain physical movements may contribute to its appearance. Surgical treatment is recommended if medical treatment fails, and trapezectomy is currently considered the standard method, although 3rd generation trapeziometacarpal prostheses are also available.

The aim of this study is to compare the clinical and radiographic results after surgical treatment of rhizarthrosis: prosthesis versus trapezectomy.

Detailed description: This is a two-center, randomized, prospective, comparative study.

The functional, clinical and radiographic evaluation in the early, medium and long term will make it possible to determine the possible superiority of arthroplasty if it exists.

The close evaluation of the patients during the first 3 months will make it possible to update the superiority of the arthroplasty on the functional recovery in the short term if it exists.

Eligibility criteria: Inclusion Criteria:

1. Age \>45 years
2. Symptomatic trapezius-metacarpal osteoarthritis after failure of medical treatment ( night orthosis 3 months + failure of 2 infiltrations/year)
3. Patient who has given his/her consent to participate in the study after being informed by the surgeon,
4. Patient living in France and able to answer the survey alone.
5. Subject affiliated to a social security system or beneficiary of such a system
6. No participation in any other clinical study

Exclusion Criteria:

1. Minor patient
2. Trapezium height \< 8 mm
3. Major subject protected by law, under curatorship or guardianship
4. Known allergy to the materials of the medical device
5. Local infection
6. Local skin necrosis or unhealed wound
7. Pregnant or nursing women

Primary outcomes:
measure: patient assessment of the wrist
timeFrame: 4 weeks
Secondary outcomes:
measure: patient assessment of the wrist pain
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinique BIZET
Study officials:
References:
Clinical trial NCT00312689: Microbiological Examination of Children Operated for Congenital Lacrimal Stenosis
Official title: Microbiological Examination of Children Operated for Congenital Lacrimal Stenosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congenital Lacrimal Stenosis
Keywords: congenital
lacrimal
stenosis
bacteria
microbiological
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2006-04-10
Enrollment: 120
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Children with congenital lacrimal stenosis are treated by probing and intubation of the lacrimal drainage system.

Hypothesis: Microbiological findings at the time of insertion and removal of the silicon intubation have an influence on the clinical outcome and success rate of the surgical treatment. Microbiological specimens are taken from conjunctiva and nasal mucosa during the two procedures under general anaesthesia and from the silicon tube after removal and examined for bacterial contamination.

Detailed description: Children (age 0-14 years) with congenital lacrimal stenosis in whom probing and intubation of the lacrimal drainage system is indicated are included the study after informed written consent by their parents. Microbiological specimens are taken bilaterally from conjunctiva and nasal mucosa during the two procedures under general anaesthesia (insertion and removal of the silicon intubation) and from the silicon tube after removal. Specimens are examined for bacterial contamination. Microbiological findings are correlated with clinical data about the further clinical course and especially the success of the surgical treatment.

Eligibility criteria: Inclusion Criteria: age 0-14 years, congenital lacrimal stenosis, informed consent by the parents -

Exclusion Criteria: none

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Augenklinik
Study officials:
affiliation: University Hospital Muenster
name: Annette Kolck, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01118689: Dose Escalation Study of MLN0128 in Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia
Official title: A Phase I, Open Label, Dose Escalation Study of Oral Administration of Single Agent MLN0128 in Subjects With Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Relapsed Multiple Myeloma
Refractory Multiple Myeloma
Waldenstrom Macroglobulinemia
Lead sponsor: Millennium Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2010-05-07
Enrollment: 39
Sex: ALL
Minimum age (years): 18
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 determine the safety, tolerability, maximum tolerated dose and pharmacokinetics of MLN0128 in patients with Relapsed or Refractory Multiple Myeloma or Waldenstrom Macroglobulinemia


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years, including males and females;
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2;
* Life expectancy of ≥3 months;
* Does not have diabetes and has normal fasting serum glucose and fasting triglycerides ≤ 300 mg/dL
* For women of child-bearing potential, negative serum pregnancy test within 14 days prior to the first study drug administration and use of physician-approved method of birth control from 30 days prior to the first study drug administration to 30 days following the last study drug administration;
* Male subjects must be surgically sterile or must agree to use physician-approved contraception during the study and for 30 days following the last study drug administration;
* Ability to swallow oral medications;
* Ability to understand and willingness to sign informed consent form prior to initiation of any study procedures;

Exclusion Criteria:

* Have received prior cancer therapy or other investigational therapy within 2 weeks prior to the first administration of study drug.
* Known impaired cardiac function or clinically significant cardiac disease
* HIV infection;
* Failed to recover from the reversible effects of prior anticancer therapies:
* Pregnancy (positive serum or urine pregnancy test) or breast feeding;
* Malabsorption due to prior gastrointestinal (GI) surgery, GI disease;

Primary outcomes:
measure: determine the dose limiting toxicities
timeFrame: 28-days
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Boston
country: United States
state: Massachusetts
city: St. Louis
country: United States
state: Missouri
city: Hackensack
country: United States
state: New Jersey
city: Nashville
country: United States
state: Tennessee
Study officials:
affiliation: Millennium Pharmaceuticals, Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05257889: Neonatal Seizures in NICU of Assuit University Children's Hospital
Official title: An Overview on Neonatal Seizures in Neonatal Intensive Care Unit of Assuit University Children's Hospital, a Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neonatal Seizure
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-02-25
Enrollment: 554
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ALL neonates (preterm and full-term infants) aged 0 to 28 days who are admitted to the neonatal intensive care unit of Assiut University Children's hospital

Brief summary: A cross sectional study on neonatal seizures in Assuit University Children's hospital NICU.

Detailed description: An Overview on neonatal seizures in neonatal intensive care unit of Assuit University Children's hospital , a cross sectional study. The aim of this study is to evaluate the clinical seizures during the neonatal period and its prevalence

Eligibility criteria: Inclusion Criteria:

* ALL neonates (preterm and full-term infants) aged 0 to 28 days who are admitted to the neonatal intensive care unit of Assiut University Children's hospital during the period of the study will be included

Exclusion Criteria:

* Neonates with multiple congenital anomalies (other than CNS anomalies)

Primary outcomes:
measure: prevalence of neonatal seizures among neonates admitted to Assiut University children's hospital
timeFrame: 1 year
Secondary outcomes:
measure: number of patients with controlled seizures during hospital admission period
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References: