louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02449889: A Randomised Trial Using Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) in Women Undergoing Controlled Ovarian Stimulation
Official title: A Randomised, Controlled, Assessor-blind, Parallel Groups, Multicentre Trial Comparing the Efficacy and Safety of Highly Purified Human Chorionic Gonadotropin (HP-hCG) and Recombinant Human Chorionic Gonadotropin (rhCG) for Triggering of Final Follicular Maturation in Women Undergoing Controlled Ovarian Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infertility
Lead sponsor: Ferring Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-05-20
Enrollment: 176
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is investigating the efficacy and safety of highly purified human chorionic gonadotropin (HP-hCG) and recombinant human chorionic gonadotropin (rhCG) for triggering of final follicular maturation in women undergoing controlled ovarian stimulation


Eligibility criteria: Inclusion Criteria:

* Pre-menopausal females between the ages of 18 and 39 years
* Documented history of infertility
* Body mass index (BMI) between 17.5 and 32.0 kg/m2
* Regular menstrual cycles

Exclusion Criteria:

* Known endometriosis stage III and IV
* Known polycystic ovarian syndrome (PCOS)
* History of recurrent miscarriage
* History of more than three previous controlled ovarian stimulation cycles

Primary outcomes:
measure: Number of Oocytes Retrieved
timeFrame: Approximately 36 hours after hCG administration
Secondary outcomes:
measure: Number of Metaphase II (MII) Oocytes
timeFrame: Prior to insemination (within 6 hours after oocyte retrieval)
measure: Number of Fertilized (2 Pronuclei (2PN)) Oocytes
timeFrame: One day after oocyte retrieval
measure: Positive β Unit of Human Chorionic Gonadotropin (βhCG) Rate
timeFrame: 13-15 days after transfer
measure: Clinical Pregnancy Rate
timeFrame: 5-6 weeks after transfer
measure: Frequency of Adverse Events (AEs)
timeFrame: AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented
measure: Intensity of AEs
timeFrame: AEs were collected from signing informed consent until end of trial visit = maximum period approximately 5 months. However, only TEAEs are presented.
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto Ideia Fértil de Saúde Reproductive (there may be other sites in this country)
Study officials:
affiliation: Ferring Pharmaceuticals
name: Clinical Development Support
role: STUDY_DIRECTOR
References:
Clinical trial NCT00293189: Gene-Polymorphies in the P2X7 Gene in Patients With Osteoporotic Fractures
Official title: Gene-Polymorphies in the P2X7 Gene in Patients With Osteoporotic Fractures
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hip Fracture
Keywords: hip fracture
epidemiology
genetics
p2x7
Lead sponsor: Kolding Sygehus
Sponsor class: OTHER
Collaborators: name: Hvidovre University Hospital
First posted: 2006-02-17
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: We are looking after gene-polymorphies in the p2x7-gene in patient with osteoporotic fractures.


Eligibility criteria: Inclusion Criteria:

* hip fracture, no dementia, low energy fracture

Exclusion Criteria:

* high energy fracture

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kolding
country: Denmark
facility: Dept of orthopaedics, Kolding Sygehus
Study officials:
affiliation: Dept of Orthopaedics, Kolding Sygehus
name: Steen A Schmidt, md
role: STUDY_CHAIR
References:
Clinical trial NCT03459989: Comparison Between Fetal Thigh Soft Tissue Versus Hadlock's Formula in Estimation of Fetal Weight by Ultrasound
Official title: Accuracy of Two Dimensions Ultrasonography of Fetal Thigh Soft Tissue Versus Hadlock's Formula in Estimation of Fetal Weight
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Estimation of Fetal Weight
Keywords: hadlock
thigh soft tissue
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-03-09
Enrollment: 200
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population comprises 200 pregnant women at 38 to 40 week of gestation attending outpatient clinic and emergency Ain Shams University Maternity Hospital, Obstetrics and Gynaecology Department, Faculty of medicine.

Brief summary: We are going to do 2d ultrasound to compare between hadlock's formula and thigh soft tissue formula in expecting the after birth fetal weight and to find which of these formulas to be more accurate

Detailed description: We are going to do 2d ultrasound to 200 pregnant women between 38 weeks to 40 weeks singleton pregnancy in Ain Shams University Maternity Hospital to measure the expected fetal weight by hadlock's formula and thigh soft tissue formula and then we are going to measure the actual fetal weight after birth of these 200 fetuses and to find out which formula to be more accurate in estimation of fetal weight

Eligibility criteria: Inclusion Criteria:

1. Gestational age 38 - 40 wks
2. Singleton uncomplicated pregnancies
3. Normal amniotic fluid volume

Exclusion Criteria:

Women with one of the following conditions:

1. Fetuses with congenital anomalies,
2. The biometric measurements of those, which were unable to ascertain due to reasons like deeply engaged head, very thick abdominal wall etc.

Primary outcomes:
measure: Fetal weight
timeFrame: 38 weeks to 40 weeks of gestation
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams Universitiy
Study officials:
affiliation: Ain Shams University
name: Adel SH Salah El-Din, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT06004089: Vaginal Transluminal Endoscopic Sacrocolpopexy
Official title: Vaginal Transluminal Endoscopic Sacrocolpopexy: A Minimal Invasive Approach for Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pelvic Organ Prolapse
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2023-08-22
Enrollment: 11
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the outcomes of V-NOTES sacrocolpopexy following vaginal hysterectomy, focusing on perioperative and early postoperative results. The impact of V-NOTES sacrocolpopexy on patients' quality of life is investigated using validated assessment tools. Additionally, operative time, complications, pain scores were assessed.

Detailed description: Patients who presented to the obstetrics and gynecology outpatient clinic with complaints related to pelvic organ prolapse, had stage III or IV prolapse according to POP-Q classification, were between 45 and 79 years old, had no contraindications for pneumoperitoneum and Trendelenburg position, and were eligible to perform transvaginal NOTES and gave written informed consent were included in the study. Demographic data, age, medical and surgical history, body mass index (BMI), operation time, preoperative and postoperative haemoglobin levels, perioperative complications and length of hospital stay were collected. Pelvic organ prolapse quantification (POP-Q) scores were evaluated before and 1 month after surgery. Quality of life was evaluated before and 1 month after surgery with the Turkish-validated Pelvic Floor Impact Questionnaire (PFIQ-7) and Pelvic Floor Distress Inventory (PFDI-20).

Eligibility criteria: Inclusion Criteria:

* Patients who presented to the obstetrics and gynecology outpatient clinic with complaints related to pelvic organ prolapse, had stage III or IV prolapse according to POP-Q classification, were between 45 and 79 years old, had no contraindications for pneumoperitoneum and Trendelenburg position, and were eligible to perform transvaginal NOTES were included in the study.

Exclusion Criteria:

* Patients with previous pelvic inflammatory disease, deep endometriosis, severe pelvic adhesions, and patients who are at risk of gynecological malignancy and are not suitable for transvaginal surgery were not included in the study.

Primary outcomes:
measure: The impact of V-NOTES sacrocolpopexy on patients' quality of life regarding daily activities and emotional health
timeFrame: 1 month
measure: The impact of V-NOTES sacrocolpopexy on patients' quality of life regarding level of discomfort
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kartal Dr. Lutfi Kirdar City Hospital
state: Kartal
Study officials:
affiliation: Kartal Dr. Lutfi Kirdar City Hospital
name: Elif Gundogdu, M.D.Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05997589: Financial Health Educational Program for Increasing Financial Literacy Among Underserved Communities in Western New York
Official title: Money Matters 101: A Pilot Community-Based Financial Health Educational Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic and Lymphoid System Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This clinical trial evaluates a financial health educational program to educate and increase knowledge for financial health and well-being, and to ensure access to financial knowledge and resources among underserved community members in Western New York. Financial well-being consists of a person's ability to meet financial obligations, feelings of financial security, ability to make choices related to financial matters. Information gathered from this study may help researchers learn how a financial health educational program may increase financial literacy for financial health and well-being among underserved community members in Western New York.

Detailed description: PRIMARY OBJECTIVES:

I. Collaborate with community organizations and leaders to leverage community-based assets to disseminate education about financial literacy.

II. Reach medically underserved, high risk community members. III. Enhance financial literacy knowledge among medically underserved, high risk community members.

OUTLINE:

Participants attend financial health educational program over 60 minutes. Patients also receive educational materials on study.

After completion of study intervention, patients are followed up to 30 days.

Eligibility criteria: Inclusion Criteria:

* Being over 18 years old

Exclusion Criteria:

* Adults unable to consent

Primary outcomes:
measure: Success of program dissemination (Feasibility)
timeFrame: Up to 1 year
measure: Satisfaction of financial health educational program (Acceptability)
timeFrame: Up to 1 year
measure: Effectiveness of community based education
timeFrame: Up to 1 year
Secondary outcomes:
measure: Changes in financial literacy knowledge
timeFrame: Baseline to 1 year
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Elizabeth Bouchard
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04194489: Trial of the Families Moving Forward (FMF) Connect Mobile Health Intervention
Official title: Feasibility Trial of the FMF Connect Mobile Health Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fetal Alcohol Spectrum Disorders
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-12-11
Enrollment: 171
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test a new smartphone "app" for parents/caregivers of children with fetal alcohol spectrum disorder (FASD). The app is called Families Moving Forward (FMF) Connect. The goal of the app is to provide parents/caregivers with useful information to help manage their children's condition and obtain peer support.


Eligibility criteria: Inclusion Criteria:

* Biological parent or other primary caregiver (e.g., foster or adoptive parent, relative, legal guardian) of a child with FASD or prenatal alcohol exposure (PAE)
* The parent/caregiver must be at least 18 years old
* The child must between the ages of 3 and 12 years old
* The child has a diagnosis of FASD or has confirmed PAE
* The child has lived with the parent/caregiver for at least 4 months and is expected to remain in the home for at least 1 year
* The parent/caregiver lives in the United States
* The parent/caregiver has a smartphone with iOS or Android operating system

Exclusion Criteria:

* The parent/caregiver is not fluent in English (the FMF Connect app and pre-post measures are currently only available in English)
* There is another parent/caregiver of the same child or living in the home that is already enrolled in the study (couples are excluded to prevent dependence in the data)
* The family has previously received or is currently receiving the therapist-led Families Moving Forward (FMF) Program

Primary outcomes:
measure: Eyberg Child Behavior Inventory at Baseline and 3-Month Follow-Up
timeFrame: baseline to 3-month follow-up
measure: Parenting Sense of Competence - Satisfaction Sub-scale at Baseline and 3-Month Follow-up
timeFrame: baseline to 3-month follow-up
measure: Parenting Sense of Competence - Efficacy Sub-scale Baseline to 3-Month Follow-up
timeFrame: baseline to 3-month follow-up
measure: Family Needs Questionnaire Baseline to 3-Month Follow-up
timeFrame: baseline to 3-month follow-up
Secondary outcomes:
measure: Participant Perception of Self-care Change Over Intervention Period Reported at 3-month Follow-up
timeFrame: 3-month follow-up
measure: Mean App Quality Score on Mobile App Rating Scale: User Version
timeFrame: 3-month follow-up
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
References:
Clinical trial NCT05429489: Erector Spinae Plane Block Versus General Anesthesia in Breast Cancer Surgeries
Official title: Comparison of the Efficacy of Bilevel Erector Spinae Plane Block and Single Level Erector Spinae Plane Block Versus General Anesthesia in Breast Cancer Surgeries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims at comparing the analgesic efficacy and safety of bilevel erector spinae versus single level versus general anesthesia for breast cancer surgeries


Eligibility criteria: Inclusion Criteria:

* Female
* Diagnosed with breast cancer

Exclusion Criteria:

* Patient refusal
* coagulation defects
* bone metastases
* abnormal kidney and/or liver function tests

Primary outcomes:
measure: Total analgesic requisite
timeFrame: First 24 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Walaa Y Elsabeeny
Study officials:
affiliation: National Cancer Institute (NCI)
name: Walaa Y Elsabeeny, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06139289: A Review of External Ventricular Drain Placement at the Bedside Versus Operating Room
Official title: A Review of External Ventricular Drain Placement at the Bedside Versus Operating Room
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: External Ventricular Drain
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2023-11-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ≥18 years old Any patient undergoing EVD placement at MDMC between January 2018 and August 2022

Brief summary: External ventricular drain (EVD) placement is a common neurosurgical procedure and provides a way to monitor intracranial pressure. EVDs are utilized in the management of a wide array of neurosurgical indications, such as subarachnoid hemorrhage, trauma, intraventricular hemorrhage, cerebrospinal fluid (CSF) leaks, and hydrocephalus.

Detailed description: External ventricular drain (EVD) placement is a common neurosurgical procedure and provides a way to monitor intracranial pressure. EVDs are utilized in the management of a wide array of neurosurgical indications, such as subarachnoid hemorrhage, trauma, intraventricular hemorrhage, cerebrospinal fluid (CSF) leaks, and hydrocephalus. While generally regarded as safe, EVDs are associated with a significant risk of complications, such as hemorrhage, infection, and improper placement resulting in a need for replacement and the patient undergoing an additional procedure.

Significant research has been conducted reducing these complications, with a major focus on issues with the procedure itself, instruments utilized for EVD placement, or post-procedure care of the EVD. To the knowledge, few investigations have focused on the EVD placement environment ( the operating room versus the bedside). Aim to evaluate the circumstances and complications rates associated with EVD placement between these two settings at Methodist Dallas Medical Center (MDMC).

Eligibility criteria: Inclusion Criteria:

* • Patients ≥18 years old

  * Any patient undergoing EVD placement at MDMC between January 2018 and August 2022

Exclusion Criteria:

* • Any patient not meeting criteria in section 3.1

Primary outcomes:
measure: EVD Placement Success
timeFrame: 30 Days
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: Methodist Health System
name: Richard Meyrat, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Foreman PM, Hendrix P, Griessenauer CJ, Schmalz PG, Harrigan MR. External ventricular drain placement in the intensive care unit versus operating room: evaluation of complications and accuracy. Clin Neurol Neurosurg. 2015 Jan;128:94-100. doi: 10.1016/j.clineuro.2014.09.026. Epub 2014 Oct 5.
Clinical trial NCT01695889: Is There a Relationship Between Previous Exposure to General Anesthesia and the Development of Alzheimer´s Disease?
Official title: A Case-control Study of Exposure to General Anesthesia and a Diagnosis of Alzheimer´s Disease Later in Life.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alzheimer´s Disease
General Anesthesia
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2012-09-28
Enrollment: 877
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases from a regional Alzheimer´s disease record. Matched controls from the national population register.

Brief summary: The purpose of this study is to compare exposure to general anesthesia between cases with a diagnosis of Alzheimer´s disease and controls without diagnosis, through studies of medical records. The investigators wish to explore if there is a relationship between exposure to general anesthesia and the development of Alzheimer´s disease.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Alzheimer´s disease
* Previous exposure to anesthesia

Exclusion Criteria:

* Inability to retrieve medical records

Primary outcomes:
measure: Exposure to general anesthesia
timeFrame: Up to 20 years in retrospect
Secondary outcomes:
measure: Exposure to inhaled anesthetics
timeFrame: Up to 20 years in retrospect
Other outcomes:
Locations:
city: Linkoping
country: Sweden
facility: University Hospital
Study officials:
affiliation: University Hospital Linkoping
name: Christina Eintrei, professor
role: STUDY_CHAIR
References:
Clinical trial NCT00823589: Immune Status of Elderly Population Admitted in an Acute Geriatric Unit
Official title: Immune Status of Elderly Population Admitted in an Acute Geriatric Unit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: ELDERLY POPULATION
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2009-01-15
Enrollment: 78
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: Ageing is associated with vulnerability against infections leading to increased morbidity with risk of death. Innate and adaptive immunities are altered with ageing responsible of deficits in immune response against pathogens and after vaccination, and favouring the elderly vulnerability against a new pathogen with increased bacterial, viral, and fungal infections.

If immunity has been widely studied in immunosenescence, there are few prospective, comparative studies with elderly ill patients. Moreover among these studies, pathologies are not well defined.

The main objective of our project is to compare the immune state of elderly hospitalised subjects in an acute geriatric unit to the immune state of elderly healthy subjects selected with strict criteria, in order to precise the impact of polypathology and of various pathologies on immunity state.


Eligibility criteria: Inclusion Criteria:

* Subject of 75 or more years old, female or male
* Subject admitted in the service of short stay gériatrique of the hospital Holy Marguerite, whatever is the motive for admittance
* Subject not being under supervision(guardianship), nor guardianship
* Subject benefiting from a benefit system
* Subject having given its assent of participation or for which the reliable person gave her assent in the case of vulnerable person

Exclusion Criteria:

* Subject of less than 75 years old
* Subject refusing to participate in the study or for whom(which) the reliable person refuses the participation of the subject

Primary outcomes:
measure: compare the immune state of elderly hospitalised subjects in an acute geriatric unit to the immune state of elderly healthy subjects
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: HOPITAL DE SAINTE MARGUERITE Service de Gériatrie Sud
state: Paca
Study officials:
affiliation: Assistance Publique Hopitaux De Marseille
name: ELODIE CRETEL
role: PRINCIPAL_INVESTIGATOR
References: