louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03901131: PROMES: A Clinical Study in Which Researchers Want to Learn More About the Safety Profile of MESIGYNA (Norethisterone Enantate 50 mg and Estradiol Valerate 5 mg) Used as a Medication to Prevent Pregnancy for Adult Women in Reproductive Age in the Peruvian Population at the Outpatient Clinic.
Official title: PROMES: PROspective, Non-Interventional, Observational, Longitudinal Study to Describe the Safety Profile of MESIGYNA® (Norethisterone Enantate 50 mg and Estradiol Valerate 5 mg) as a Contraceptive Method for Women in Reproductive Age at the Outpatient Clinic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraceptive
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2019-04-03
Enrollment: 296
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who have been prescribed Mesigyna in Peru.

Brief summary: Clinical study in which researchers want to learn more about the safety profile of MESIGYNA used as a medication in routine clinical practice to prevent pregnancy. In order to find this out researchers will collect historic and treatment related data during initial visit and follow-up visits of adult women in reproductive age in the Peruvian population at the outpatient clinic. Mesigyna is a combined injectable birth control medication (norethindrone ethanate (50 mg) and estradiol valerate (5 mg)) for women given monthly.


Eligibility criteria: Inclusion Criteria:

* Adult female patients,18 to 45 years old with a Mesigyna prescription
* Women for whom the decision to initiate contraception with Mesigyna was made as per investigator's routine practice
* Signed Informed Consent

Exclusion Criteria:

* Women participating in an investigational program with interventions outside of routine clinical practice
* Hypersensitivity to norethisterone enantate or estradiol valerate

Primary outcomes:
measure: Frequency of Adverse Events and Serious Adverse Events
timeFrame: Up to 6 months
Secondary outcomes:
measure: The number of injections
timeFrame: Up to 6 months
measure: Number of injections
timeFrame: Up to 6 months
measure: Frequency of injections
timeFrame: Up to 6 months
measure: Comorbidities associated to greater incidence of AE and SAE
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Multiple Locations
country: Peru
facility: Many locations
Study officials:
References:
Clinical trial NCT06445231: Echocardiography in Nursing Home
Official title: Implementation and Effectiveness of Screening Echocardiography Performed in Nursing Home: ECHOGER
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Diseases
Heart Failure
Heart Valve Diseases
Keywords: Echocardiography
Nursing Home
Implementation
Heart Failure
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
Collaborators: name: Directorate of Health Care Supply
First posted: 2024-06-06
Enrollment: 1050
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Nursing home randomization in 1:1 ratio between echocardiography and no-echocardiography
Primary purpose: SCREENING

Brief summary: The study seeks to explore the implementation characteristics (acceptability, appropriateness, feasibility, adoption, fidelity, penetration, implementation cost and sustainability) of systematic echocardiography in nursing homes and its impact on rates of heart failure flare-up and unscheduled hospitalization at 12 months among included nursing homes.

Detailed description: Open-label cluster randomized type 1 hybrid trial, with 2 parallel arms: nursing homes will be randomized in the interventional (echocardiography by sonographer) or non-interventional arms (usual care). In the interventional arm echocardiography will be proposed to all residents of the nursing home at baseline. Clinical management will be adapted to the result of echocardiography by the general practitioner, in accordance with the cardiologist. The main objective is to assess the impact at 12 months of the initial performance of a systematic simplified echocardiography on the rate of nursing home residents presenting with heart failure episode or cardiovascular pathology. The Primary endpoint is the number of nursing home residents presenting a heart failure episode or an unscheduled hospitalization for heart failure or other cardiovascular pathologies at 12 months.

Thirty nursing homes and 1050 residents will be included overall

Eligibility criteria: Inclusion Criteria :

Nursing homes residents with a life-expectancy estimated \> 1 year, and able to participate to the study, giving an oral consent

Exclusion Criteria :

* no accessible to echocardiography
* closed unit (severe Alzheimer disease...)
* recent contagious disease such Covid (\<15 days)
* no consent to participate
* no social security number

Primary outcomes:
measure: Count of resident presenting a heart failure decompensation
timeFrame: 12 months
Secondary outcomes:
measure: Presence of a clinically significative change in medical management and care in the month following ultrasound
timeFrame: 12 months
Other outcomes:
Locations:
city: Nantes
country: France
facility: Nantes University Hospital
state: Loire-Atlantique
Study officials:
affiliation: Nantes University Hospital
name: Thierry LE TOURNEAU, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01581931: Bioequivalence of Metformin Under Fed Conditions After Administration of Linagliptin / Metformin Fixed Dose Combination Tablet and Single Tablets
Official title: Bioequivalence of Metformin Under Fed Conditions After Administration of a 2.5 mg Linagliptin / 500 mg Metformin Fixed Dose Combination Tablet Compared With Single Linagliptin 2.5 mg and Metformin 500 mg Tablets Administered Together in Healthy Male and Female Volunteers, (an Open-label, Randomised, Single Dose, Two-way Crossover, Phase I Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2012-04-20
Enrollment: 32
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 establish bioequivalence (BE) under fed conditions between metformin in linagliptin/metformin fixed dose combination tablet and metformin reference product administered in free combination togther with linagliptin


Eligibility criteria: Inclusion criteria:

1. Healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

Primary outcomes:
measure: Area Under Curve From 0 to tz Hours (AUC0-tz) of Metformin
timeFrame: 0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours
measure: Maximum Concentration (Cmax) of Metformin
timeFrame: 0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours
Secondary outcomes:
measure: Area Under Curve From 0 to Infinity Hours (AUC0-infty) of Metformin
timeFrame: 0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours
measure: Time to Maximum Concentration (Tmax) of Metformin
timeFrame: 0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours
measure: Terminal Half-life t1/2 of Metformin
timeFrame: 0:20, 0:40, 1, 1:30, 2, 3, 4, 5, 6, 8, 12, 24, 34, 48, 72 hours
Other outcomes:
Locations:
city: Biberach
country: Germany
facility: 1288.20.1 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT03938831: Dexmedetomidine and Delirium in Elderly Patients
Official title: Effect of Dexmedetomidine in Postoperative Delirium in Hip Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Delirium, Dexmedetomidine, Postoperative PCA
Lead sponsor: Korea University Guro Hospital
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized control
Primary purpose: PREVENTION

Brief summary: Investigators investigates the effect of perioperative dexmedetomidine 0.5 ug/kg/hr followed by a postoperative continuous infusion fentanyl-based PCA(Patient-Controlled Analgesia) drug mixed with dexmedetomidine 0.2ug/kg/hr for two days on reducing postoperative delirium and postoperative rescue analgesics in elderly patients who undergo hip surgery. The other half of patients received fentanyl-based PCA only.

Detailed description: Elderly patients are susceptible to postoperative delirium. Delirium occurs in 10\~60% and is associated with longer hospital stays, increased costs, and morbidity. Postoperative delirium usually occurs 2\~3 days after surgery. Intraoperative infusion of dexmedetomidine lacks preventing postoperative delirium in elderly noncardiac major surgery.

We hypothesized postoperative dexmedetomidine for two days as a mixture drug of fentanyl-based PCA could reduce the incidence of postoperative delirium. We compared this effect with other control group who received fentanyl-based PCA only.

We also investigate EEG patterns of patients during emergence and compared the EEG patterns who developed delirium postoperatively in PACU(Postanesthesia care unit) or general ward. Dexmedetomidine has analgesic effect. We expected postoperative dexmedetomidine has benefits of opioid sparing effects.

Eligibility criteria: Inclusion Criteria: over 65 yrs old elderly patient who undergo elective hip surgery and ASA(The American Society of Anesthesiologists) physical status I-III

Exclusion Criteria:

history of dementia, drug abuser, hypersensitivity to dexmedetomidine, fentanyl, propofol, disable to speech, reject the clinical study, hemodynamic instability during surgery, an illiterate, pregnancy

Primary outcomes:
measure: delirium
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: KoreaUniversity Guro Hospital
state: Guro-ku
Study officials:
affiliation: Korea University Guro Hospital
name: Il-Ok Lee, professor
role: STUDY_CHAIR
References:
Clinical trial NCT04067531: Treatment of BV With First Deqularum and Then Direkt After Clindamycin
Official title: Treatment of BV With First Deqularum and Then Direkt After With Vaginal Clindamycin Cream.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Infection, Bacterial
Lead sponsor: Skaraborg Hospital
Sponsor class: OTHER_GOV
First posted: 2019-08-26
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Treatment of BV with first deqularum cloride and then followed with clindamycin vaginal Cream.

Detailed description: The hypoteses is that deqularum cloride takes away the biofilm so that clindamycin will kills the bacteria.

Cure rate will be followed up after 1 month and then after 6 month

Eligibility criteria: Inclusion Criteria:

* healthy women with BV

Exclusion Criteria:

* women treated with antibiotics within 1 month

Primary outcomes:
measure: cure of BV
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Skövde
country: Sweden
facility: Department of Ob/Gyn, Skaraborgshospital Skövde
Study officials:
affiliation: professor
name: P-G Larsson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06547931: Duffy-null Associated Neutrphil Count (DANC) Pediatric Patients
Official title: Retrospective Analysis of a Cohort of Duffy-null Associated Neutrophil Count (DANC) Pediatric Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neutropenia Autoimmune
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 150
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients sent to our laboratory for the search for anti-neutrophil antibodies in the suspicion of immune neutropenia

Brief summary: There are currently no clinical and laboratory data that well characterize this neutropenia associated with the Duffy-null phenotype, particularly for pediatric subjects. In particular there are no data on the frequency of immune neutropenia in DANC neutropenic pediatric subjects.

The goal of this study is to :

* define the frequency of immune neutropenia within the cohort of DANC subjects under study
* evaluate the frequency of different degrees of neutropenia (mild-moderate-severe);
* evaluate the possible association between different degrees of neutropenia and the presence of infections.


Eligibility criteria: Inclusion Criteria:

* presence of Duffy-null phenotype

Exclusion Criteria:

* absence of Duffy-null phenotype

Primary outcomes:
measure: Immune neutropenia and DANC
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Distribution of mild, moderate and severe neutropenia in DANC children
timeFrame: Through study completion, an average of 1 year
Other outcomes:
measure: Neutropenia severity and infections
timeFrame: Through study completion, an average of 1 year
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggioe Policlinico
Study officials:
References:
citation: Hsieh MM, Everhart JE, Byrd-Holt DD, Tisdale JF, Rodgers GP. Prevalence of neutropenia in the U.S. population: age, sex, smoking status, and ethnic differences. Ann Intern Med. 2007 Apr 3;146(7):486-92. doi: 10.7326/0003-4819-146-7-200704030-00004.
citation: Ortiz MV, Meier ER, Hsieh MM. Identification and Clinical Characterization of Children With Benign Ethnic Neutropenia. J Pediatr Hematol Oncol. 2016 Apr;38(3):e140-3. doi: 10.1097/MPH.0000000000000528.
citation: Rappoport N, Simon AJ, Amariglio N, Rechavi G. The Duffy antigen receptor for chemokines, ACKR1,- 'Jeanne DARC' of benign neutropenia. Br J Haematol. 2019 Feb;184(4):497-507. doi: 10.1111/bjh.15730. Epub 2018 Dec 27.
citation: Merz LE, Li SH, Ney G, Michniacki TF, Hannibal MC, Walkovich KJ. Absolute neutrophil count nadir in healthy pediatric patients with the Duffy-null phenotype. Blood Adv. 2023 Aug 8;7(15):4182-4185. doi: 10.1182/bloodadvances.2023010368. No abstract available.
citation: Bux J, Behrens G, Jaeger G, Welte K. Diagnosis and clinical course of autoimmune neutropenia in infancy: analysis of 240 cases. Blood. 1998 Jan 1;91(1):181-6.
Clinical trial NCT05842031: Assessment of Patient Experience and Needs for Patients Undergoing Invasive Inguinal Lymph Node Procedures for Penile Cancer
Official title: Assessment of Patient Experience and Needs for Patients Undergoing Invasive Inguinal Lymph Node Procedures for Penile Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Penile Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2023-05-03
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: M D Anderson Cancer Center

Brief summary: To learn more about the patient experience undergoing inguinal (in the groin) lymph node procedures for penile cancer during and after surgery.

Detailed description: Objectives

Primary Objective:

To understand the lived experience of patients undergoing invasive inguinal lymph node procedures.

Secondary Objective:

To determine factors that influence decisions and improve experience for patients who need invasive inguinal lymph node procedures.

Eligibility criteria: Inclusion Criteria:

--Patients diagnosed with penile cancer who have undergone invasive inguinal node procedures (ILND and/or DSNB) and are at least 6 months post-procedure

Exclusion Criteria:

* Patient's ≤18 years of age
* Patients who have not undergone invasive surgical procedures involving the inguinal lymph nodes
* Non-English-speaking patients For interviews: people who are physically and/or cognitively incapable of participating in a 60minute telephone interview as determined by a clinical provider or the patient.

Primary outcomes:
measure: Decision Regret Scale (DRS) questionnaires
timeFrame: through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson
state: Texas
Study officials:
affiliation: MD Anderson
name: Curtis Pettaway, BS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05663931: Diabetes Toolkit at Discharge
Official title: Implementation and Testing of a Diabetes Discharge Intervention to Improve Safety During Transitions of Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Insulin Dependent Diabetes
Keywords: Insulin
Hospital discharge
Transitions of care
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized clinical trial is to implement the DM Discharge Toolkit into hospital discharge and assess the effect of the DM Discharge Toolkit on patients newly requiring insulin.

Detailed description: This study is a randomized controlled trial with a parallel group design of up to 120 study participants in a 1:1 ratio to receive either current standard of care discharge DM training (control) or current standard of care discharge DM training and the DM Discharge Toolkit (intervention) before or immediately after being sent home to assume self-DM care with insulin.

Eligibility criteria: Inclusion Criteria:

* English speaking patients
* 18 years of age and older
* Expected survival \>90 days
* Need for new insulin at time of hospital discharge

Exclusion Criteria:

* Patients with the inability to give informed consent
* Non-English speaking
* Not diagnosed with diabetes
* Not been newly prescribed insulin

Primary outcomes:
measure: Mean glucose levels
timeFrame: 30 days
Secondary outcomes:
measure: Number of hypoglycemic episodes
timeFrame: 14, 30 and 90 days
measure: Number of hyperglycemic episodes
timeFrame: 14, 30 and 90 days
measure: Healthcare utilization
timeFrame: 14, 30 and 90 days
measure: HbA1c
timeFrame: 90 days
measure: Time in hyperglycemia
timeFrame: 14 days
measure: Time in hypoglycemia
timeFrame: 14 days
measure: Mean amplitude of glycemic excursion
timeFrame: 14 days
measure: Glycemic variability
timeFrame: 14 days
measure: Diabetes Symptoms Questionnaire
timeFrame: 14 days, 30 days
measure: Summary of Diabetes Self Care Activities
timeFrame: 14 days, 30 days
measure: Diabetes Distress Scale
timeFrame: 14 days, 30 days
measure: Hospital Consumer Assessment of Healthcare Providers and Systems
timeFrame: 14 days, 30 days
measure: Partner Diabetes Distress Scale
timeFrame: Baseline, 30 days, 90 days
measure: Perceived Stress Scale
timeFrame: Baseline, 30 days, 90 days
measure: Infection
timeFrame: 30 and 90 days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Amisha Wallia, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02350231: Progesterone Vaginal Pessary for Prevention of Preterm Twin Birth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Preterm Birth
Keywords: preterm birth
Twin pregnancy
progesterone
Lead sponsor: Assiut University
Sponsor class: OTHER
Collaborators: name: Sohag University
First posted: 2015-01-29
Enrollment: 100
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Multiple pregnancies accounted for 1 - 6 % of all births in UK during 2007. More than 98% of these multiple births being twin births . Preterm birth defined as birth occurring prior to 37 weeks of gestation and it was about 15 % of pregnancies in developed world and 12.7 % in the United States.

Preterm birth is the leading cause of infant and neonatal mortality. Premature neonates are at increased risk of developing respiratory distress syndrome, sepsis, intraventricular hemorrhage, and necrotizing enterocolitis.

Twin pregnancy is considered one of the important risk factors of preterm birth. Over distension of uterus may be one of the etiological factors for preterm birth. However, no definite effective interventions have been shown to prevent preterm delivery in twin pregnancy.

Three large randomized trials suggested that progesterone might prevent preterm delivery in high-risk singleton pregnancy especially those with previous preterm delivery or short cervix might be reduced by antenatal progesterone.

Fonseca et al (2007) concluded that women with short cervix are less likely to deliver preterm ≤34 weeks if they are treated with vaginal progesterone.


Eligibility criteria: Inclusion Criteria:

1. Diamniotic twin pregnancy
2. Gestational age ± 28 weeks.

Exclusion Criteria:

1. Higher multiple pregnancy
2. IUFD of one or both fetuses
3. Any congenital anomalies
4. IUGR or discordant twins
5. PROM
6. If there is any contraindication to progesterone treatment
7. Women who did performed cervical cerclage in the current pregnancy
8. Difficult in follow up for the pregnant women as (living faraway area, or difficult transportion, etc).
9. Threatened preterm labor.
10. Polyhydromnis.
11. Other medical disorder with pregnancy

Primary outcomes:
measure: Time of delivery
timeFrame: from 28 weeks till delivery
Secondary outcomes:
measure: Mode of delivery
timeFrame: from 28 weeks till delivery
measure: Birth weight
timeFrame: at time of delivery
measure: The need for neonatal intensive care incubator.
timeFrame: after delivery
Other outcomes:
Locations:
Study officials:
References: