louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02197715: Sex and Female Empowerment
Official title: Improving Women's Sexual Health While in Drug Addiction Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use Disorder
Keywords: Pregnancy
Contraceptive Methods
Family Planning Services
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2014-07-23
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will develop and initially evaluate Sex and Female Empowerment (SAFE), an intervention designed to increase acceptance of and adherence to contraceptive practices among opioid-agonist-maintained women of childbearing age. The intervention will be delivered in one of two formats: a face-to-face brief intervention approach or a novel computer-adaptive platform. To the extent that either version of SAFE is found to be efficacious compared with usual care, it has the potential to reduce the number of unintended pregnancies and consequently decrease the need for and the costs of child protective services.


Eligibility criteria: Inclusion criteria will be:

1. ages 18-40 years old for women;
2. able to provide informed consent;
3. currently enrolled in a opioid-agonist-maintenance program;
4. currently not pregnant (urine testing confirmation);
5. report heterosexual orientation;
6. no tubal ligation or other sterilization;
7. no plans to become pregnant in the next 6 months; and
8. provides verifiable locator information.

Primary outcomes:
measure: Intervention Satisfaction
timeFrame: The earlier of the completion of the 4 interventions sessions or 6 weeks.
measure: Contraceptive Consultation Appointment
timeFrame: The earlier of the completion of the 4 intervention sessions or 6 weeks.
measure: Intervention Completion
timeFrame: The earlier of the completion of the 4 interventions sessions or 6 weeks.
measure: Contraceptive Method Effectiveness
timeFrame: The earlier of the completion of the 4 intervention sessions or 6 weeks.
Secondary outcomes:
measure: Knowledge of Reproduction
timeFrame: Baseline, 1-, 3-, and 6-months post-baseline
measure: Knowledge of Contraceptive Methods
timeFrame: Baseline, 1-, 3-, 6-months post-baseline
measure: Contraceptive Self-efficacy Scale
timeFrame: Baseline, 1-, 3-, and 6-months post-baseline
measure: Effective Contraceptive Behavior
timeFrame: Baseline, 1-, 3-, and 6-months post-baseline
measure: Frequency of Use of Barrier Protection in past 30 days
timeFrame: Baseline, 1-, 3-, and 6-months post-baseline
measure: Number of Times Engaged in Unprotected Sex in past 30 days
timeFrame: Baseline, 1-, 3-, and 6-months post-baseline
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Horizons
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Hendrée E Jones, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06360315: Impact of a Letter Encouraging Pneumococcal Vaccination on the 1-year Vaccination Rate in Heart Failure Patients With a Primary Care Physician
Official title: Impact of a Letter Encouraging Pneumococcal Vaccination on the 1-year Vaccination Rate in Heart Failure Patients With a Primary Care Physician
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Heart Failure
Keywords: Heart failure
Hospitalization
Pneumococcal vaccination
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 12000
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Heart failure affects more than 1.5 million people in France, resulting in over 70,000 deaths and more than 165,000 hospitalizations each year. Viral and bacterial infections are frequently associated with episodes of acute heart failure in patients with chronic heart failure (CHF). Lower respiratory tract infections, such as influenza and pneumococcus, are common causes of hospitalization for decompensated heart failure, leading to increased morbidity and mortality. Studies have shown that pneumococcal vaccination can reduce the risks of heart attack or stroke in patients with heart failure. However, despite vaccination recommendations, coverage rates remain low, especially for pneumococcus. In this study, we will evaluate the impact of an incentive letter for pneumococcal vaccination on one-year hospitalization rate in patients with heart failure.


Eligibility criteria: Inclusion criteria:

* Adult patients over 45
* Residing in the Occitanie region, France
* With heart failure registered as ALD
* Who have declared an attending physician
* Who have not received a pneumococcal vaccination for more than 24 months (due to the length of time available in the database)

Exclusion criteria:

-None

Primary outcomes:
measure: 1-year Pneumococcus vaccination rate
timeFrame: at 1-year
Secondary outcomes:
measure: 1-year all-cause hospital admission rate
timeFrame: at 1-year
measure: 1-year specific hospital admission rate
timeFrame: at 1-year
measure: 1-year all-cause mortality rate
timeFrame: at 1-year
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
Study officials:
References:
Clinical trial NCT04776915: Congenital Uterine Anomalies & Pregnancy in Polycystic Ovarian Syndrome
Official title: Investigation of the Effect of Serum Androgen and Anti-Mullerian Hormone Levels on the Frequency of Müllerian Anomalies and Pregnancy Outcomes in Patients With Polycystic Ovarian Syndrome Undergoing Invitro Fertilization
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mullerian Anomaly of Uterus, Nec
Keywords: mullerian anomaly, PCOS, antimullerian hormone
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Infertile Patients who undergo IVF\&ICSI treatment

Brief summary: Prospective research in which patients who applied to UUTF Gynecology and Obstetrics ART center for the treatment of infertility (inability to conceive despite one year of unprotected sexual intercourse), who will undergo IVF due to PCOS and unexplained infertility

Detailed description: As of 01/10/2020, IVF cycles of patients with PCOS (n = 105) and unexplained infertility (n = 105) who have applied to Bursa Uludag University Gynecology and Obstetrics Department, Reproductive Treatments Center, will be included in the study. Demographic data of all patients (age, BMI, smoking), presence of hyperandrogenism findings such as systemic diseases, hirsutism, alopecia, FSH, LH, LH/FSH ratio, estradiol levels, pregestational serum AMH levels, uterine anomalies detected by transvaginal USG or hysterosalpingography, controlled ovarian hyperstimulation protocols and doses; Besides, DHEA-S, Free Testosterone, 17-OH Progesterone levels will be recorded in patients diagnosed with PCOS. All these data are routine laboratory and imaging parameters of patients who underwent in vitro fertilization in our UYTE center. Pregnancy results of the patients (biochemical pregnancy, anembryonic pregnancy, abortion, clinical pregnancy, live birth), perinatal results and complications during clinical pregnancy, delivery ways, and newborn APGAR scores will be recorded. Results will be compared with patients in the control group diagnosed with unexplained infertility.

Eligibility criteria: Inclusion Criteria:

* Being in the age range of 20-40
* Need for an assisted reproductive method due to PCOS or unexplained infertility

Exclusion Criteria:

* \<20 years or \>40 years
* Detecting a cause for infertility other than PCOS

Primary outcomes:
measure: The rate of Mullerian Abnormality
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Uludag University ART Center
Study officials:
affiliation: Bursa Uludag University School of Medicine ART Center
name: Özge Albayrak, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02158715: Assessment of Validity of Depth by PocketCPR as Sites of Smartphone on Arm
Official title: Assessment of Validity of Depth by PocketCPR as Sites of Smartphone on Arm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chest Compression With Smartphone
Lead sponsor: Hanyang University
Sponsor class: OTHER
First posted: 2014-06-09
Enrollment: 45
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Basic Life Support certtification licenced by American Heart Association

Clinical experience more than 3 years associated with CPR

Brief summary: For Cardiopulmonary Resuscitation(CPR) education, depth of chest compression is most important teaching point. However, the tool to feedback depth of chest compression like Resusci Annie Skill Reporter(Laedal Medical AS, Norway) is very helpful but too expensive to be used widely. In these days, smartphone free application can measure depth of chest compression in real-time. This study assess the validity of depth of chest compression by smartphone application, PocketCPR, as three sites of smartphone on arm or hand.

1. grap it in hand, 2. fix it on upper arm with arm band, 3. grap it in hand with arm band

To analyze the difference between Skill Reporter manikin and PocketCPR application, the investigators will use Intraclass Correlation Coefficient(ICC) as statistical method.


Eligibility criteria: Inclusion Criteria:

* Chest compressor with Basic Life Support certification
* Physician, Nurse, Emergency medical technician with more than 3 years clinical experience

Exclusion Criteria:

* Person who cannot practice normal chest compression with any reason

Primary outcomes:
measure: Depth of chest compression
timeFrame: up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang medical center
Study officials:
References:
Clinical trial NCT03956615: sdAb-based TRNT of Multiple Myeloma: a Feasibility Study
Official title: sdAb-based Targeted Radionuclide Therapy of Multiple Myeloma: a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Myeloma
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
Collaborators: name: Stichting tegen Kanker
First posted: 2019-05-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study aims to show that antiidiotypic sdAb are a new, sensitive, specific and non-invasive tool for imaging and therapeutic purposes and provides a rationale for their clinical evaluation as a personalized treatment option for MM patients expressing surface paraprotein.


Eligibility criteria: Inclusion Criteria:

Patients will only be included in the study if they meet all of the following criteria:

* Patients who have given informed consent
* Patients at least 18 years old
* Patients scheduled to undergo bone marrow sampling in clinical routine because of a clinically suspected or pathologically confirmed multiple myeloma.

Exclusion Criteria:

Patients will not be included in the study if one of the following criteria applies:

* Patients who cannot communicate reliably with the investigator
* Patients who are unlikely to cooperate with the requirements of the study
* Patients at increased risk of death from a pre-existing concurrent illness
* Patients who participated already in part I of this study

Primary outcomes:
measure: Fraction of Patients (n=3) for Whom a sdAb Could be Generated That Binds to the Idiotype of the Paraprotein.
timeFrame: Within 2 years after study completion
measure: Amount of Paraprotein-targeting sdAbs Generated Per Patient
timeFrame: Within 2 years after study completion
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UZ Brussel
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Marleen Keyaerts, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05072015: Systematic Follow up of Second Line Treatments for Parkinson's Disease (Deep Brain Stimulation, Apomorphin Pump, Duodopa Pump)
Official title: Systematic Follow up of Second Line Treatments for Parkinson's Disease (Deep Brain Stimulation, Apomorphin Pump, Duodopa Pump)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Parkinson's Disease
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-10-08
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced Parkinson' s disease who need second line treatment

Brief summary: Primary purpose: Fluctuations and dyskinesia evolution in Parkinson's disease patients, one year after initiation of deep brain stimulation, apomorphin pump or duodopa pump

Secundary purposes:

* Motor complications evolution at 6 months, 2 and 3 years
* MDS UPDRS III score at 6 months, 1, 2 and 3 years
* non motor complications evolution at 6 months, 1, 2 and 3 years
* cognition and psychiatric complications evolution at 6 months, 1, 2 and 3 years
* cutaneous and digestive complications at 6 months, 1, 2 and 3 years
* neuropathy occurrence at 6 months, 1, 2 and 3 years
* medical treatment and Levodopa equivalent dose modifications at 6 months, 1, 2 and 3 years


Eligibility criteria: Inclusion criteria:

* Parkinson disease (UKPDSSB criteria)
* Patient with fluctuations and/or dyskinesia , who need treatment with deep brain stimulation, apomorphin pump or duodopa pump
* MOCA \>20
* patient \>21 years of age
* patient who has signed protocol acceptation

Exclusion criteria:

* patient who did not give his acceptation for the protocol
* patient with another parkinsonian syndrome than Parkinson' s disease
* MOCA\<20
* Patient who does not need second line treatment

Primary outcomes:
measure: MDS UPDRS IV (Movement Disorder Society - Unified Parkin-son Disease Rating Scale) score improvement
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Mathieu ANHEIM
Study officials:
affiliation: Les Hôpitaux Universitaires de Strasbourg
name: Mathieu ANHEIM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06924515: The Application Value of Intercostal Suturing in Preventing Postoperative Thoracoscopic Lung Resection Chest Wall Pulmonary Hernia
Official title: The Application Value of Intercostal Suturing in Preventing Postoperative Thoracoscopic Lung Resection Chest Wall Pulmonary Hernia
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: VATS
Lung Hernia
Keywords: lung hernia
VATS
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2025-04-11
Enrollment: 104
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this trial is to understand whether intercostal suture can effectively prevent postoperative chest wall lung herniation, mainly to verify the following questions Can intercostal suture reduce postoperative chest wall lung herniation The hemostatic effect and hemostatic time of intercostal suture on intercostal muscle incision bleeding during surgery The researchers will divide the participants into two groups, one group will receive intercostal suture, and the other group will not receive intercostal suture, that is, conventional suture The participants will Receive or not receive intercostal suture during surgery Hemostatic effect and hemostasis time of rib intermuscular incision bleeding during surgery Chest CT will be reviewed 3 months after surgery to observe the chest wall incision


Eligibility criteria: Inclusion Criteria:

* Patients undergoing lung resection via multiport thoracoscopic surgery:The intercostal muscles at the main incision site need to be dissected using an electrocautery knife.Intercostal incisions should be used with a retractor and an incision protector to prevent damage to intercostal nerves and blood vessels,as well as rib fractures.

Age greater than or equal to 18 years No history of thoracic surgery

Exclusion Criteria:

* During the operation,if a patient's multiport thoracoscopic surgery needs to be converted to a thoracoscopic-assisted mini-thoracotomy,a rib retractor becomes necessary.

During the operation,conversion to thoracotomy or a conventional posterolateral incision may be necessary based on the specific intraoperative circumstances.

Uniportal thoracoscopic surgery History of ipsilateral thoracic surgery

Primary outcomes:
measure: Postoperative chest CT at 3 months
timeFrame: From enrollment to the end of treatment at 3 months
measure: Hemostasis time
timeFrame: From enrollment to the end of surgery
Secondary outcomes:
measure: Postoperative drainage volume within 3 days
timeFrame: Postoperative Day 1,Day 2,Day 3
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References:
Clinical trial NCT04769115: A Predictive Technology for Prevention of Diabetic Foot Ulcers
Official title: A Predictive Technology for Prevention of Diabetic Foot Ulcers, and in Real Time, Identifying Diabetic Patients Who Experience Lower Extremity Trauma and Vascular Obstruction Utilizing the Science of Temperature (Inflammation) Trending
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Foot Ulcer
Keywords: DFU
Lead sponsor: DAPS Health LLC
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 45
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Diabetics who have no history of lower extremity (LEX) complications Diabetics who a history of LEX complications
Primary purpose: PREVENTION

Brief summary: The DAPSHealth system employs a predictive technology for prevention of diabetic foot ulcers, and in Real Time, identifies diabetic patients who experience lower extremity trauma and vascular obstruction utilizing the science of temperature trending.

Detailed description: Diabetes has become a major health issue in the United States and globally, particularly among older populations. There are currently 400 million diabetics worldwide, with 30 million diagnosed diabetics living in the US.

The standard of care today in treating complications of diabetes is a reactive one: doctors often wait for a problem to occur and then treat it. This waiting approach results in high medical expenses and an increase in pain for patients.

This study is testing a predictive technology system (investigational bluetooth-enabled thermometer and mobile app) to see if it can identify potential foot complications before the damage becomes irreversible. The thermometer being used in this study is the Exergen DermaTemp (DT) Thermometer. Participants will check the temperature of each foot daily for a period of three months. These results will sync directly from the thermometer to the mobile app.

Patients are notified when temperature levels indicate a potential complication that may lead to a developing foot ulcer. The study doctor is available to determine if any trauma or vascular obstruction has occurred and will follow up with the participant.

Eligibility criteria: Inclusion Criteria:

* diagnosis of diabetes
* ambulatory
* smart device

Exclusion Criteria:

* non-ambulatory
* no smart device

Primary outcomes:
measure: Predicting diabetic foot complications
timeFrame: Evaluate results daily and compare previous results to analyze multiple days with a contralateral delta of 4 degrees or more. This will be a running comparison over the three months of the trial.
Secondary outcomes:
Other outcomes:
Locations:
city: Annapolis
country: United States
facility: Annapolis Foot & Ankle
state: Maryland
Study officials:
affiliation: DAPS Health LLC
name: Mark Sussman, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00979615: Safety and Efficacy of Olopatadine 0.6% and Azelastine 137 Mcg in Vasomotor Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vasomotor Rhinitis
Keywords: vasomotor rhinitis
chronic non-allergic rhinitis
VMR
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-09-18
Enrollment: 129
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine safety and efficacy of Patanase and Astelin in treating the symptoms of non-allergic vasomotor rhinitis (VMR).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of VMR with at least 2 years of chronic non-allergic rhinitis
* Negative skin tests to a panel of allergens and positive histamine test within last 2 years
* History of symptoms related to defined VMR triggers

Exclusion Criteria:

* Nasal disorder, surgery, or concurrent disease that could interfere with evaluation of study medications
* Bacterial or viral infection within 14 days of first visit. Diagnosis of acute sinusitis within 30 days of first visit
* Chronic use of drugs that can cause rhinitis

Primary outcomes:
measure: Mean Change in 2-week rTNSS From Baseline
timeFrame: 2 week
Secondary outcomes:
measure: Mean Change in Rhinorrhea Reflective Score
timeFrame: 2 week
measure: Mean Change Postnasal Drip Reflective Score
timeFrame: 2 Weeks
measure: Mean Change Nasal Congestion Reflective Score
timeFrame: 2 Weeks
measure: Mean Change in Sneezing Reflective Score
timeFrame: 2 Weeks
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center For Trial Locations
state: Texas
Study officials:
References: