louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00000279: Novel Medications for Opiate Detoxification - 4
Official title: Novel Medications for Opiate Detoxification
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Substance-Related Disorders
Keywords: Opioid-Related Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: VA Connecticut Healthcare System
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate novel medications for opiate detoxification.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Withdrawal severity
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System
name: Thomas R Kosten, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: AM J Drug & Alc. Abuse 21(4): 453-467, 1995; Neuropsychopharm 13(4): 323-333, 1995; Neuropsychopharm 14(3): 187-193, 1996; J Pharma & Experimental Therapeutics 276(3): 1128-1135, 1996.
Clinical trial NCT06603779: Integrated Neuromuscular Inhibition Versus Cervical and Scapular Stabilization Exercises on Myofascial Trigger Points of Upper Trapezius
Official title: Integrated Neuromuscular Inhibition Versus Cervical and Scapular Stabilization Exercises on Myofascial Trigger Points of Upper Trapezius: Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigger Point Pain, Myofascial
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial will involve three groups. The Integrated Neuromuscular Inhibition group will receive the integrated neuromuscular inhibition technique. The cervical and Scapular stabilization group will receive cervical and scapular stabilization exercises. The ultrasound group will receive ultrasound therapy


Eligibility criteria: Inclusion Criteria:

* Patients with active trigger points in the upper trapezius for more than 2 weeks based on the Simons Criteria.
* Age ranged from 18-25 years.
* Pain intensity ≥ 3 on VAS.
* Females and males.

Exclusion Criteria:

* Patients indicated for surgery.
* Patients with symptomatic disc lesions.
* Patients with rheumatological diseases or traumatic neck injury.
* Patients injected with corticosteroids in the last 6 months.

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 1-3 months
measure: Pressure Pain Algometer
timeFrame: 1-3 months
measure: Neck Pain and Disability Questionnaire (NDI)
timeFrame: 1-3 months
measure: 36-item Short-Form Health Questionnaire
timeFrame: 1-3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beni-Suef
country: Egypt
facility: Faculty of Physical Therapy
Study officials:
References:
Clinical trial NCT02621879: Bilateral Gluteal Fascio-myo-cutaneous Flap in Treatment of Recurrent Pilonidal Disease
Official title: Bilateral Gluteal Fascio-myo-cutaneous Advancement Flap in Treatment of Recurrent Sacrococcygeal Pilonidal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pilonidal Sinus
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2015-12-04
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Bilateral Gluteal Fascio-myo-cutaneous Advancement Flap is a modified technique used in Treatment of Recurrent Sacrococcygeal Pilonidal sinus

Detailed description: Patients with recurrent pilonidal sinus disease are recruited to undergo Bilateral Gluteal Fascio-myo-cutaneous Advancement Flap technique under spinal anesthesia in order to prevent recurrence.

Eligibility criteria: Inclusion Criteria:

* Patients with recurrent sacrococcygeal pilonidal disease aging more than 16 years with single or multiple pits were included in the study.
* Patients included presented with recurrence of pilonidal disease at least six months after the first operation.

Exclusion Criteria:

* Patients aging less than 16 years.
* Patients unfit for anesthesia.
* Patients with primary pilonidal disease.
* Patients with acute pilonidal abscess or active infection.

Primary outcomes:
measure: Incidence of recurrence
timeFrame: 18 months
Secondary outcomes:
measure: Incidence of complications
timeFrame: 18 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura Univesity
name: Sameh H Emile, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05529979: Epione® Post-Market Clinical Follow-up Study
Official title: Post-Market Clinical Follow-Up Study of a Robotic Device for Image Guided Percutaneous Needle Placement in the Abdomen
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cancer Abdomen
Keywords: Percutaneous
CT-guided
Ablation
Biopsy
Abscess Drainage
Fiducial Placement
Abdomen
Liver
Kidney
Robotics
Lead sponsor: Quantum Surgical
Sponsor class: INDUSTRY
First posted: 2022-09-07
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated/operated in routine practice, in accordance with the device's intended use, without any additional nor burdensome procedure.

Brief summary: Post-Market Clinical Follow-up study in order to consolidate performance and safety data of the EPIONE® device when used for percutaneous procedures in the abdomen

Detailed description: The objective of this PMCF study is to compile data on the routine use of the EPIONE® device in subjects undergoing CT-guided percutaneous procedures in the abdomen.

The objectives are:

1. to evaluate the technical success of the device
2. to evaluate performance parameters (accuracy measures, adjustements, post-intervention ablation success, local tumor recurrence, operator satisfaction) and the safety of the device

55 patients are planned in this post-market study.

Eligibility criteria: Inclusion Criteria:

* Patient \>18 years old,
* Patient for whom a CT-guided procedure in abdomen has been prescribed and agreed by a multidisciplinary team of radiologists, surgeons and clinicians,
* Patient with a confirmed non-opposition.

Exclusion Criteria:

* Patient unable to undergo general anesthesia,
* Pregnant or breast-feeding females

Primary outcomes:
measure: Technical Success
timeFrame: through study completion up to 36 months
Secondary outcomes:
measure: Needle placement accuracy
timeFrame: through study completion up to 36 months
measure: Number and nature of needle adjustments to reach the target
timeFrame: through study completion up to 36 months
measure: Post-intervention ablation success
timeFrame: through study completion up to 36 months
measure: Local tumor recurrence
timeFrame: through study completion up to 36 months
measure: Operator satisfaction
timeFrame: through study completion up to 36 months
measure: Adverse Events related to device or procedure
timeFrame: through study completion up to 36 months
measure: Device dysfunction
timeFrame: through study completion up to 36 months
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Gustave Roussy Institut
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: THIERRY DE BAERE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01208779: Epidemiology Study in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer
Official title: An Epidemiological, Non-interventional Study to Evaluate Patient Compliance in Postmenopausal Women With Estrogen Receptor Positive Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hormon Receptor Positive Breast Cancer
Keywords: Compliance
HR+ breast cancer
epidemiology
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-09-24
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Oncology centers

Brief summary: This observational study in estrogen receptor positive early breast cancer patients is aimed to evaluate the patients' compliance to aromatase inhibitor (AI) therapy and to collect country-specific data in estrogen receptor positive early breast cancer patients including data on demography, disease characteristics and disease management.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal females with estrogen receptor positive breast cancer that are currently treated with aromatase inhibitor (AI) medication
* Provision of subject informed consent

Exclusion Criteria:

* If participating in any clinical trial, the subject cannot take part in this study.

Primary outcomes:
measure: Evaluate compliance rate, as assessed by investigator, after 12 months from baseline.
timeFrame: 12 months
Secondary outcomes:
measure: Evaluate compliance rate, assessed by investigator, after 6 months of follow up
timeFrame: 12 months
measure: Evaluate the extent of patient educational activities as assessed by patient (using patient questionnaire) after 6 and 12 months
timeFrame: 12 months
measure: Evaluate patient compliance as assessed by the patient (using patient questionnaire) after 6 and 12 months
timeFrame: 12 months
measure: Collect epidemiology data; Demographic data: age, height, weight, lifestyle, menarche, childbirth, lactation, menopausal status
timeFrame: 12 months
measure: Primary disease (breast cancer) characteristics: receptor status, disease stage
timeFrame: 12 months
measure: Disease management data: treatment/treatment changes
timeFrame: 12 months
Other outcomes:
Locations:
city: Vojvodina
country: Serbia
facility: Research Site
state: Sremska Kamenica
city: Belgrade
country: Serbia
facility: Research Site
Study officials:
affiliation: M.D.spec of oncology, Institute for oncology Vojvodina, Sremska Kamenica
name: Dr Jasna Pesic
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05354479: Breastmilk Alone or in Combination With Paracetamol for Reducing Pain
Official title: Efficacy of Expressed Breast Milk Alone or in Combination With Paracetamol in Reducing Pain During ROP Screening
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain Control
Lead sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Sponsor class: OTHER
First posted: 2022-04-29
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blinded Randomized control trial
Primary purpose: SUPPORTIVE_CARE

Brief summary: Efficacy of Expressed Breast Milk Alone or in Combination with Paracetamol in Reducing Pain during ROP Screening.

Detailed description: Retinopathy of prematurity (ROP) has been widely acknowledged to be the primary cause of preventable childhood blindness in developing countries. However, the procedure for screening is extremely painful. In this study, we will attempt to relieve the pain experienced by these babies using breast milk alone or in combination with oral paracetamol. This randomized control trial study will be conducted with the aim to assess the efficacy of Expressed Breast Milk Alone or in Combination with Paracetamol in Reducing Pain during ROP Screening. All preterm neonate who undergone ROP screening will be the study population. A total of 60 preterm neonates will be randomized into three groups: (Group A - control group = 20, Group B - breast milk group = 20, and Group C - oral paracetamol + breast milk = 20). Group A will get current care as per institutional protocol, Group B received 2 ml expressed breast milk (EBM) through a sterile syringe orally 2 min prior to procedure, Group C received syrup paracetamol, 15 mg/kg 30 min prior to procedure and EBM as in Group B. Pain experienced was measured by the premature infant pain profile (PIPP) score 20 s prior, during and 2 min after procedure. All procedures were video recorded. The Ophthalmologist and analyzer both will be blinded to the intervention. Results will be incorporated after enrollment

Eligibility criteria: Inclusion Criteria:

* 1. Gestational age \<35 weeks, and birth weight \<2000 gm

Exclusion Criteria:

* 1. Parents of neonate who refused to participate in the study 2. Newborns with multiple congenital anomalies 3. Patient who is on mechanical ventilator during ROP examination 4. Neonate receiving narcotic or sedative drugs 5. Neonate not receiving oral feed.

Primary outcomes:
measure: Decrease in pain
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: BSMMu
Study officials:
References:
Clinical trial NCT01303679: 1st Line Treatment of Bevacizumab-Taxane vs Bevacizumab-Exemestane in Metastatic Breast Cancer
Official title: Phase III Randomized Multicenter Trial Comparing Continued Maintenance Therapy With the Bevacizumab + Taxane Versus Bevacizumab + Substituting Exemestane in Patients With Metastatic Breast Cancer or Locally Advanced With Estrogen Receptor Positive and Having at Least a Stable Disease After 16 to 18 Weeks of Treatment With Bevacizumab + Taxane.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: First Line Metastatic Breast Cancer
Keywords: First line metastatic breast cancer
Positive estrogen receptors
Negative HER2 receptors
At least stable disease after 4 months of paclitaxel-bevcizumab induction chemotheray
Lead sponsor: ARCAGY/ GINECO GROUP
Sponsor class: OTHER
First posted: 2011-02-25
Enrollment: 117
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In first-line metastatic breast cancer, the bevacizumab-taxane to progression or toxicity, is currently the standard treatment. In patients expressing hormone receptors, it was shown that hormone therapy administered in maintenance after induction chemotherapy, could have a benefit regarding the progression-free survival. The investigators make the hypothesis that there would be interest to discontinue treatment with taxane after 4 months, and to begin hormone therapy while continuing maintenance bevacizumab.

Exemestane was chosen because it has been shown potentially active in patients who progressed after letrozole, anastrozole or tamoxifen.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 ans.
* Metastatic breast cancer or locally advanced
* RE+, HER2-
* Patient receiving paclitaxel-bevacizumab first line chemotherapy

Exclusion Criteria:

* Previous treatment by exemestane (both in adjuvant or metastatic treatment).
* 1st line of chemotherapy different thaan paclitaxel-bevacizumab.
* Treatment by paclitaxel-bevacizumab \> 18 weeks.
* HER2 positifs et/ou récepteurs aux oestrogènes négatifs.
* Previous thrombosis event within the 6 months before inclusion .
* Previous significant surgery within the 28 days before treatment start
* Previuous coagulopathy.

Primary outcomes:
measure: Primary free survival
timeFrame: 24 months for recruitment and 18 months for follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: BACHELOT
Study officials:
affiliation: GINECO
name: Thomas BACHELOT, Md
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tredan O, Follana P, Moullet I, Cropet C, Trager-Maury S, Dauba J, Lavau-Denes S, Dieras V, Beal-Ardisson D, Gouttebel M, Orfeuvre H, Stefani L, Jouannaud C, Burki F, Petit T, Guardiola E, Becuwe C, Blot E, Pujade-Lauraine E, Bachelot T. A phase III trial of exemestane plus bevacizumab maintenance therapy in patients with metastatic breast cancer after first-line taxane and bevacizumab: a GINECO group study. Ann Oncol. 2016 Jun;27(6):1020-1029. doi: 10.1093/annonc/mdw077. Epub 2016 Feb 24.
Clinical trial NCT04697979: Post-Stroke Medication Relay
Official title: Post-Stroke Medication Relay
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stroke, Ischemic
Medication Compliance
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2021-01-06
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults patients managed in stroke unit following ischemic stroke who benefiting from a direct return at home.

Brief summary: Prior to discharge from hospital and return home, patients managed for ischemic stroke will receive a pharmaceutical interview to discuss their discharge prescription (indication, method of administration, precautions, and possible side effects).

Improvements in the use of medications in the community and in hospital follow-up.

Telephone interviews or teleconsultations will make it possible to assess the patient's knowledge of his or her treatment and to re-explain it if necessary to improve patient compliance with treatment.


Eligibility criteria: Inclusion Criteria:

* Adult patients managed in stroke unit following ischemic stroke
* Benefiting from a direct return home
* Non-opposition to participation

Exclusion Criteria:

- None

Primary outcomes:
measure: Assess the value of a telephone interview / teleconsultation after discharge from hospital following an ischemic stroke
timeFrame: 1 week
measure: Assess the value of a telephone interview / teleconsultation after discharge from hospital following an ischemic stroke
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Neurologie Vasculaire, Unité 201 Hôpital Neurologique Pierre Wertheimer, HCL
Study officials:
References:
Clinical trial NCT04596579: SARS-CoV-2 (COVID-19) Immune Surveillance Among a Population Based Sample of Adults in Florida
Official title: SARS-CoV-2 Immune Surveillance Among a Population Based Sample of Adults in Florida
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Infection
Keywords: COVID -19
SARC-CoV-2
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2020-10-22
Enrollment: 1135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community Sample

Brief summary: The overall goal of this study is to understand the immune response (IgG) to SARS-CoV-2 to fill critical knowledge gaps in the natural history of this virus and to inform the development of future infection mitigation efforts. The study team aims to assess the prevalence of circulating IgG antibodies to SARS-CoV-2 and the factors associated with sero-prevalence. These data will be used to estimate the total population that has been exposed to the virus (asymptomatic and symptomatic), the proportion of the population that may be protected by natural immunity, and the proportion that is susceptible. Data obtained from this research will be shared with the Florida Department of Health.


Eligibility criteria: Inclusion Criteria:

* Resident of Hillsborough County, Florida
* 18 years of age or older
* Currently not exhibiting symptoms of SARS-CoV-2 infection

Primary outcomes:
measure: Percentage of Participants who test positive for SARS-CoV-2 antibodies at first visit
timeFrame: At study start
measure: Percentage of Participants who test positive for SARS-CoV-2 antibodies at second visit
timeFrame: At 4 weeks
measure: Percentage of Participants who test positive for SARS-CoV-2 antibodies at third visit
timeFrame: At 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
Study officials:
affiliation: Moffitt Cancer Center
name: Anna R Giuliano, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05094479: E-health App and Lifestyle Changes During Pregnancy
Official title: E-health Application in Supporting Lifestyle Changes During Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Dietary Habits
Physical Activity
Gestational Weight Gain
Keywords: Pregnancy
Health application
Diet quality
Physical activity
Gestational weight gain
Lead sponsor: University of Turku
Sponsor class: OTHER
Collaborators: name: Business Finland
First posted: 2021-10-26
Enrollment: 1047
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this online follow-up study is to investigate health app use in pregnant women and through a pilot intervention trial investigate whether the addition of evidence-based information on health-promoting lifestyle delivered via the health app has an effect on lifestyle habits (gestational weight, diet quality and physical activity) during pregnancy.

Detailed description: An online follow-up study with a 2-arm equal allocation parallel randomized controlled pilot intervention trial with pregnant women (n=1000) will be conducted. The intervention consists of non-personalized, evidence-based information on health-promoting lifestyle during pregnancy delivered via a health app. Control group uses the health app without health information.

Aims of an exploratory part of the study are to characterize the health app use and users among pregnant women and to investigate whether the frequency of the health app use during pregnancy has an effect on lifestyle habits. Aim of the pilot intervention is to investigate whether the addition of evidence-based information on health-promoting lifestyle delivered via the health app has an effect on lifestyle habits during pregnancy.

Eligibility criteria: Inclusion Criteria:

* Pregnant, less than 28 pregnancy weeks
* Fluency in Finnish

Exclusion Criteria:

* Not pregnant
* No fluency in Finnish

Primary outcomes:
measure: Change in gestational weight
timeFrame: Pre-pregnancy weight reported at enrollment and current weight at late pregnancy (pregnancy weeks 35-36)
measure: Change in diet quality scores
timeFrame: At enrollment and late pregnancy (pregnancy weeks 35-36)
Secondary outcomes:
measure: Change in physical activity scores
timeFrame: At enrollment and late pregnancy (pregnancy weeks 35-36)
Other outcomes:
Locations:
city: Turku
country: Finland
facility: University of Turku
Study officials:
affiliation: University of Turku
name: Kirsi Laitinen, Assoc. Prof.
role: PRINCIPAL_INVESTIGATOR
References: