louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00685074: Computer-based Brief Intervention for Perinatal Substance Abuse
Official title: Computer-based Brief Intervention for Perinatal Drug, Alcohol, and Tobacco Abuse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Substance Abuse
Keywords: Motivational Interview
Computer based intervention
Substance abuse
post-partum
Lead sponsor: Wayne State University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2008-05-28
Enrollment: 143
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to see if a brief computer program can help new mothers cut down or quit tobacco, alcohol, or drug use.

Detailed description: The purpose of this Stage I/II intervention study (that is, Stage II for drug use and Stage I for alcohol use and smoking) is to test the efficacy of a brief, computerized motivational intervention for substance abuse among post-partum women. The study will randomly assign 350 post-partum women to either intervention or control conditions, with intervention itself taking approximately 30 minutes in the period before the participant leaves the hospital. Inclusion criteria will include post-partum status, age between 18 and 45, ability to understand spoken English, and meeting criteria for one of the three substance use groups: any illicit drug use in month prior to pregnancy, meeting T-ACE criteria for problem alcohol use, or smoking in past month. Exclusion criteria will include receipt of narcotic pain medication in the past 3 hours, no sleep since giving birth, and inability to provide informed consent (e.g., due to psychosis or other clear cognitive impairment).

Lab-based follow-up will occur at 3- and 6-months postpartum. The primary outcomes will be participant report of frequency of substance use and toxicological analyses of substance use (urinalysis and expired breath CO at 3 and 6 month follow-up, hair analysis at 6-month follow-up). Secondary outcome measures include HIV risk behaviors, receipt of treatment services, motivation to change, self-efficacy, mental health functioning, violence exposure, and consequences related to substance use.

Eligibility criteria: Inclusion Criteria:

* Hospitalized women in immediate post-partum period
* Self report of illicit drug use, problem alcohol use, or tobacco use in month prior to pregnancy

Exclusion Criteria:

* Frank psychosis or other cognitive impairment
* Inability to communicate in English
* No sleep since giving birth
* Recent receipt of narcotic pain medication
* Grieving over medically compromised infant

Primary outcomes:
measure: Drug use at 3 months
timeFrame: 3 months
measure: Drug use at 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Hutzel Women's Hospital
state: Michigan
Study officials:
affiliation: Wayne State University
name: Steven J. Ondersma, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00708474: OsseoFit™ Prospective Data Collection
Official title: OsseoFit™ Porous Tissue Matrix™ Prospective Data Collection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Bone Graft
Knee
Keywords: Bone graft
Bone void filler
Bone plug
OsseoFit™
knee
bone graft sites in the knee
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-07-02
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the fill of bone graft sites in the knee. It is hypothesized that harvest sites, voids, and defects caused by trauma that are treated with the OsseoFit™ Porous Tissue Matrix™ device will achieve a better fill grade than those treated with the conventional method.


Eligibility criteria: Inclusion Criteria:

* The OsseoFit™ Porous Tissue Matrix™ is intended to be gently packed into the bony voids or gaps of the extremities and pelvis caused by trauma or surgery and are not intrinsic to the stability of the bony structure. These defects may be created from repetitive motion or traumatic injury to the bone or surgically created osseous defects for the harvest of bone. The device is a bone void filler that resorbs and is replaced with bone during the healing process. The device may be combined with sterile fluids such as saline or autogenous blood products such as blood, platelets, or bone marrow aspirate. The addition of these autogenous blood products does not compromise the performance of the device. Hydration with biologically beneficial sterile fluids can potentially have a positive influence on the healing and replacement of the device with bone.

Exclusion Criteria:

* Infection at site
* Hypercalcemia
* Known allergies to bovine collagen
* Current osteomyelitis at operative site
* Systemic conditions which affect bone and/or wound healing
* Known severe allergies manifested by history of anaphylaxis
* Desensitization treatment injections to meat products, as injections may contain bovine collagen
* Severe degenerative bone disease

Primary outcomes:
measure: Site repair grade by MRI analysis
timeFrame: 6 months
Secondary outcomes:
measure: Site repair grade by MRI analysis
timeFrame: 3 months, 1 year
measure: Pain Score
timeFrame: 3 months, 6 months, 1 year
measure: Function Score
timeFrame: 3 months, 6 months, 1 year
measure: Physical Evaluation
timeFrame: 3 months, 6 months, 1 year
measure: Incidence of adverse events
timeFrame: Any time
Other outcomes:
Locations:
city: Warsaw
country: United States
facility: Biomet Sports Medicine
state: Indiana
Study officials:
name: Richard C Lehman, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04014374: Post-authorization Safety Study of Allogeneic Hematopoietic Stem Cell Transplantation in Patients Treated With Mogamulizumab
Official title: Post-authorization Safety Study of Allogeneic Hematopoietic Stem Cell Transplantation in Patients Treated With Mogamulizumab
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Leukemia/Lymphoma
Cutaneous T Cell Lymphoma
ATLL
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-07-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will include a minimum of 50 patients with CTCL or ATLL who received mogamulizumab within one year prior to alloHCT. At least 40 patients should have been diagnosed with CTCL and at least 33 patients should have received mogamulizumab as last therapy line before alloHCT. Data will be collected from no more than 100 controls with similar characteristics to the mogamulizumab-treated patients, and who have undergone alloHCT without exposure to mogamulizumab pre- or post-alloHCT. Information on patients receiving mogamulizumab within 18 months after alloHCT will also be collected.

Brief summary: This is a non-interventional cohort study evaluating non-relapse mortality and toxicities in patients with CTCL or ATLL treated with mogamulizumab pre- or post- alloHCT for patients transplanted beginning January 1, 2012 until accrual is complete.

Detailed description: This is an observational, retrospective and prospective study where subjects who have received mogamulizumab either within one year before or within 18 months after transplantation will be followed for data collection. Data will be collected at baseline (retrospectively), 100 days post alloHCT, 6-months, 1 year and at 2 years post alloHCT (retrospectively and prospectively).

A cut-off time limit of 18 months post alloHCT exposure will allow at least 6 months of follow-up within the 2 years post-alloHCT follow-up period.

Eligibility criteria: Inclusion Criteria:

* Patients registered to the Center for International Blood and Marrow Transplant Research (CIBMTR)
* Adults ≥18 years of age with either CTCL or ATLL;
* AlloHCT performed from January 2012 onward.

Exclusion Criteria:

• Patients without consent for research.

Primary outcomes:
measure: Assess toxicities or complications of transplant among patients who were treated with mogamulizumab, alone or in combination
timeFrame: one year prior to alloHCT to within 18 months after alloHCT
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: CIBMTR
state: Wisconsin
Study officials:
References:
Clinical trial NCT03457974: Saliva Profiles in Children With Congenital Heart Disease
Official title: Saliva Profiles in Children With Congenital Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Disease
Dental Caries
Keywords: saliva composition
antioxidant activity
caries risk factors
congenital cardiac disease
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Figen Seymen
name: Merve Bayram
name: Ezel Uslu
name: Sule Batu
name: Yegane Güven
First posted: 2018-03-08
Enrollment: 84
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: cross sectional study was carried out with 42 CHD and 42 healthy children
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study was to evaluate whether there are relationships between the salivary oxidative stress status of children with CHD directly dental caries including gender, age, salivary flow rate, salivary pH, salivary buffering capacity and drug intake such as angiotensin-converting enzyme (ACE) inhibitors. If such relationships exist, they might be employed to patient caries -prevention treatment.

Detailed description: Using heart failure medications may cause low salivary pH and buffering capacity.As improved oral health is a priority for cardiac patients, it is necessary that they attend dental clinics for regular follow up.

This cross sectional study was carried out with 42 CHD and 42 healthy children who applied to Istanbul University, Faculty of Dentistry, Department of Pedodontics. Gender, age, general health and medications, and caries scores (dfs/DMFS) were recorded. Unstimulated saliva was collected from the participants and were assessed for the salivary secretion rate, salivary buffering capacity, pH, protein levels, superoxide dismutase (SOD), ferric reducing antioxidant power (FRAP), the thiobarbituric acid reactive substances (TBARS), protein carbonyl, protein thiols, total sialic acid.

Eligibility criteria: Inclusion Criteria:

* 3-12 years
* Caridac problems

Exclusion Criteria:

* other ages
* syndromes
* other systemic diseases

Primary outcomes:
measure: salivary secretion rate
timeFrame: 2 hour
measure: salivary buffering capacity
timeFrame: 2 hour
measure: pH
timeFrame: 2 hour
Secondary outcomes:
measure: protein levels of saliva
timeFrame: 2 hour
measure: superoxide dismutase (SOD)
timeFrame: 2 hour
measure: ferric reducing antioxidant power (FRAP)
timeFrame: 2 hour
measure: the thiobarbituric acid reactive substances (TBARS)
timeFrame: 2 hour
Other outcomes:
measure: protein carbonyl
timeFrame: 2 hour
measure: protein thiols
timeFrame: 2 hour
measure: total sialic acid
timeFrame: 2 hour
Locations:
Study officials:
References:
Clinical trial NCT06003465: A Research Study Looking at Similarity Between LY3437943 Versions for Different Injection Devices
Official title: A Relative Bioavailability Study to Compare the Pharmacokinetics of LY3437943 Administered Subcutaneously by a Test Device (Test Formulation) Versus Reference Device (Reference Formulation) in Healthy Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2023-08-22
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to look at the amount of the study drug, LY3437943, that gets into the blood stream and how long it takes the body to get rid of it when given using two different devices. The study will also evaluate the safety and tolerability of LY3437943 and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately 16 weeks, including screening.


Eligibility criteria: Inclusion Criteria:

* Healthy males or non-pregnant females as determined by medical history, physical examination, and other screening procedures
* Body mass index (BMI) between 18.5 and 32.0 kilograms per meter squared (kg/m²), inclusive
* Have clinical laboratory test results, blood pressure and pulse rate that are acceptable for the study
* Are agreeable to receiving study treatment by injections under the skin
* Males who agree to use highly effective/effective methods of contraception and women not of childbearing potential (postmenopausal or oophorectomized)

Exclusion Criteria:

* Have or used to have health problems that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
* Smoke more than the equivalent of 10 cigarettes per day
* Is a known user of drugs of abuse
* Have known allergies to LY3437943 or related compounds

Primary outcomes:
measure: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943
timeFrame: Predose up to 43 days postdose
measure: PK: Area Under the Plasma Concentration Versus Time Curve from Zero to T, Last Time Point (AUC[0-tlast]) of LY3437943
timeFrame: Predose up to 43 days postdose
measure: PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of LY3437943
timeFrame: Predose up to 43 days postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: Qps-Mra, Llc
state: Florida
city: San Antonio
country: United States
facility: ICON Early Phase Services
state: Texas
city: Salt Lake City
country: United States
facility: ICON
state: Utah
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03681665: Use of Iterative Reconstruction Method in Ultralow-dose CT for Follow-up of Patients With Intraabdominal Abscess: Comparison With Standard Dose CT
Official title: Use of Iterative Reconstruction Method in Ultralow-dose CT for Follow-up of Patients With Intraabdominal Abscess: Comparison With Standard Dose CT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Abdominal Abscess
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with suspected abdominal abscess from a tertiary care clinic.

Brief summary: Increasing radiation exposure by medical examinations is getting more concerns. For optimal medical imaging, reducing radiation exposure with preservation image quality is important. One of the solutions is use of iterative recontruction of CT examination. In this study, the investigators aimed to investigate the clinical feasibility of ultralow dose abdominopelvic CT with iterative reconstruction in patients with intraabdominal abscess. Patients with intrabdominal abscess usually undergo multiple CT examinations to evaluate treatment response. Therefore, ultralow dose CT can reduce unnecessary radiation exposure in these patients.


Eligibility criteria: Inclusion Criteria:

1. patients who underwent standard dose CT for suspected intraabdominal abscess
2. patients who need follow-up CT to evaluate treatment response of abscess 3) Adult patient, 4) patients who agreed this study protocol

Exclusion Criteria:

1. pregnancy
2. patients with poor renal function (GFR \< 30 mL/min/1/73m2)
3. Patients who have allergy to CT contrast media
4. Patients who are not cooperative (e.g., dementia)

Primary outcomes:
measure: Score of subjective image quality of CT image
timeFrame: 1 month
Secondary outcomes:
measure: Effective radiation dose: CTDIvol(volume CT dose index), DLP(dose length product), effective dose(DLPx0.015)
timeFrame: 1 month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT02482220: Physical Activity Program and Energy Intake Control in Obese Adolescents
Official title: Physical Activity and Energy Intake Control in Obese Adolescents: Effect of Exercise Programs of Various Intensities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Obesity
Lead sponsor: Université Blaise Pascal, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2015-06-26
Enrollment: 70
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Acute exercise of high intensity has been shown to induced nutritional adaptations in obese adolescents. Indeed, several studies have shown that about 30 minutes of intensive exercise (above 70% of the adolescents maximal aerobic capacities) can favor reduced-energy consumption at the following meal with no modification of their appetite feelings. Although it is suggested that chronic physical activity programs can induce energy intake modifications, this has never been clearly studied. The aim of this work is to compare different physical activity programs (low vs. high intensity programs) in terms of energy intake, appetite feelings and appetite-regulating hormones, in obese adolescents.

Detailed description: After an first medical visit to ensure that the adolescents have the ability to complete the whole study, the participants will have to complete several clinical examinations:

* anthropometric measurements
* Body composition assessed by DXA
* Maximal aerobic test
* Blood samples (appetite-regulating hormones)
* daily energy intake assessment during a 24h intake exploration.

The adolescents recruited will then be randomly assigned to one of the two intervention groups:

- High Intensity program or moderate intensity program. Those two physical activity programs will last 4-months and will be composed of 3 to 4 exercise sessions per week. The High intensity program will consists in High intensity interval exercises starting at 70% of the adolescents' capacities at the beginning to end around 95%. The moderate intensity program will propose continuous exercises set between 50-65% VO2max.

No energy intake intervention will be performed.

By the end of the 4-months intervention, all the clinical examinations performed before the intervention will be repeated.

Eligibility criteria: Inclusion Criteria:

* 12 to 15 years old adolescents
* Obese according to international values for BMI
* Being registered to the national social security insurance
* no eating disorders
* no medications
* metabolic disorders

Exclusion Criteria:

* metabolic disorders
* food disorders
* physical disability

Primary outcomes:
measure: change in Energy intake in kcal is being assessed
timeFrame: energy intake will be assessed during 24h during the week before the intervention (T0) and the week after (T1)
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-ferrand
country: France
facility: AME2P Laboratory
state: Auvergne
Study officials:
References:
Clinical trial NCT06148220: A Study of the Clinical Application of [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT Imaging in the Diagnosis of CD70-expressing Multiple Tumors
Official title: A Study of the Clinical Application of [18F]RCCB6 and [68Ga]Ga-NOTA-RCCB6 PET/CT Imaging in the Diagnosis of CD70-expressing Multiple Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Cancer
Lymphomas
Positron Emission Tomography
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study was to establish and optimize the \[18F\]RCCB6 and \[68Ga\]Ga-NOTA-RCCB6 PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agents in renal cancer (especially clear cell renal cell carcinoma) and lymphoma was evaluated.


Eligibility criteria: Inclusion Criteria:

1. Be between 18 and 65 years of age and of either sex.
2. Affected with renal cancer or lymphoma confirmed by puncture or surgical pathology.
3. Informed consent must be signed in writing by the subject or his/her legal guardian or caregiver.
4. Willingness and ability to cooperate with all programs of this study.

Exclusion Criteria:

* Subjects meeting any of the following criteria will be excluded from the study:

  1. Severe hepatic and renal insufficiency;
  2. Targeted therapy prior to radiotherapy or PET/CT scan. Renal function: serum creatinine less than or equal to the upper limit of the normal range;
  3. Liver function: bilirubin, AST(SGOT)/ALT(SGPT) less than or equal to the upper limit of the normal range.
  4. History of serious surgery in the last month.
  5. Those who have participated in other clinical trials during the same period.

Primary outcomes:
measure: Complete PET imaging
timeFrame: 90mins from time of injection
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
Study officials:
affiliation: Huashan Hospital
name: Fang Xie
role: PRINCIPAL_INVESTIGATOR
References: