louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00571870: Gonadotropin-releasing Hormone Antagonist on Triggering Day: A Randomized Controlled Study
Official title: Study on the Effect of GnRH Antagonist on hCG Day on Outcomes of Controlled Ovarian Hyperstimulation With GnRH Antagonist Flexible Multiple-dose Protocols
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2007-12-12
Enrollment: 80
Sex: FEMALE
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: Gonadotropin-releasing hormone (GnRH) antagonists have been widely used for the prevention of premature luteinizing hormone (LH) surges during controlled ovarian hyperstimulation (COH) for in vitro fertilization and embryo transfer (IVF-ET) since the late 1990's.

Many years have passed since GnRH antagonists were introduced to prevent premature LH surges during stimulated cycles. However, there is still no consensus on the optimal GnRH antagonist protocol. Attempts at modifying GnRH antagonist protocols have been made to improve COH outcomes. However, a meta-analysis of 27 randomized controlled trials, including recent reports, showed significantly lower clinical ongoing pregnancy rates in the antagonist group. Thus, additional efforts are needed to identify the optimal stimulation protocols to achieve better follicular and embryonic development and to improve the pregnancy rates in COH using GnRH antagonist.

Given the assumption of a detrimental effect of GnRH antagonist on the pregnancy rate, with current protocols, we hypothesized that a shorter duration of GnRH antagonist administration might improve outcome.


Eligibility criteria: Inclusion Criteria:

* Both ovaries present with no morphological abnormalities
* Normal ovulatory cycle with cycle lengths of between 25 and 35 days
* Basal serum FSH (day 3) level of \< 15 mIU/mL
* Body mass index (BMI) ranging between 18 and 27 kg/m2

Exclusion Criteria:

* History of a poor ovarian response
* Evidence of endocrine abnormalities, such as, hyperprolactinemia, thyroid dysfunction, or polycystic ovary syndrome
* Hydrosalpinx
* Severe endometriosis (stage III-IV)

Primary outcomes:
measure: Maturity of oocytes, fertilization rate, embryo quality
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Dept. of Obstetrics and Gynecology, Seoul National University Bundang Hospital
name: Chang Suk Suh, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01059370: Autonomic Dysreflexia in Spinal Cord Injury
Official title: Autonom Dysrefleksi Ved Rygmarvsskade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autonomic Dysfunction
Spinal Cord Injured
Keywords: Autonomic dysfunction
Spinal cord injured
Neurogenic bowel
Neurogenic bladder
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2010-01-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Autonomic dysreflexia in high spinal cord-injured can be initiated by a full bladder or bowel, or when trying to empty either. This randomised study aims at evaluating whether irrigation procedure or digital stimulation or evacuation of the rectum is less provocative of autonomic dysreflexia. Participants have their bowels emptied on different days, in the morning fasting. Bladder filling with sterile saline water is evaluated on a third day as a control.


Eligibility criteria: Inclusion Criteria:

1. People with a spinal cord injury above th6 and with symptoms of autonomic dysreflexia.
2. At least one year post injury.
3. 18 years or older.
4. Informed consent.

Exclusion Criteria:

1. Usage of prophylactic anti-autonomic dysreflexia medication.
2. Pregnant or breastfeeding.
3. People who is not able to follow the sudy protocol.
4. No former major surgery in the abdomen or pelvic region.
5. No former radiotherapy in the pelvic region.

Primary outcomes:
measure: Intervention induces 25 % raise in BP compared to baseline measurements.
timeFrame: Outcome are monitored all through bowel or bladder-procedure at each of three study-days, and compaire to measurements at baseline.
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
Study officials:
affiliation: University of Århus
name: Søren Laurberg, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT00792870: Evaluation of the Shape Up Rhode Island Campaign
Official title: Evaluation of the Shape Up Rhode Island Campaign: Study 4 Does Adding Behavioral Weight Control Information to Shape-Up Rhode Island Improve Outcomes?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Weight loss
Internet
Lead sponsor: The Miriam Hospital
Sponsor class: OTHER
First posted: 2008-11-18
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Obesity is a major health problem that has reached epidemic levels. Efforts are needed to develop cost-effective public health approaches for weight loss and maintenance. One such approach is to develop team-based programs that may motivate people to lose weight and/or increase their physical activity. One such program is entitled Shape-up Rhode Island (SURI). The purpose of this project is to evaluate the overall effectiveness of SURI and to test if a behavioral intervention can enhance the effectiveness of the original program. The current trial is investigating whether adding a behavioral intervention delivered online would enhance the outcomes of SURI participants.

Detailed description: Background: Given the epidemic of obesity, approaches to weight loss that can be applied on a community, state, or national level are needed. This project is an ongoing evaluation of Shape Up Rhode Island (SURI) program, a state-wide Internet based program involving team-based competition to increase physical activity and achieve weight loss.

Aim: To enhance the effectiveness of SURI utilizing a minimal contact intervention delivered online.

Design: SURI 2008 participants were invited to join a research study focusing on weight loss. Interested participants were randomized to two groups including a SURI Enhanced (behavioral intervention presented in 12 weekly online presentations) or a SURI Standard group (group given a list of previously existing online resources to aid with weight loss).

Eligibility criteria: Inclusion Criteria:

* Overweight or obese
* Current participant in the Shape Up RI program weight loss competition

Exclusion Criteria:

* None

Primary outcomes:
measure: Weight loss at the end of Shape Up RI
timeFrame: 3 months
Secondary outcomes:
measure: Weight loss maintenance 6 months after program completion
timeFrame: 6 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: The Miriam Hospital
name: Rena R Wing, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05510570: Genetic Biomarkers Associated With Child Language Development in Taiwan (II)
Official title: Genetic Biomarkers Associated With Child Language Development in Taiwan (II)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Child Language
Keywords: language development
gene
whole-exome sequencing
body function and body structure
quality of Life
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2022-08-22
Enrollment: 115
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Control and experimental groups

Brief summary: A study of the relation between genetic biomarkers and child language development in Taiwan.

Detailed description: The interaction between gene and environment (G×E) can be a very complicated process that influences child development. As a pilot study of child development biomarkers, this study investigates genes related to child language development and language disorder.

Eligibility criteria: Inclusion Criteria:

* Age 2-18 y/o
* Agree to sign informed consent

Exclusion Criteria of Healthy Child:

* Central nervous system disease
* Neuromuscular Disorders
* Congenital Abnormality
* Genetic Disease
* Dysesthesia
* Hearing Impairment

Inclusion Criteria of Child with language disorder:

* Patients with Language Disorder
* Age 2-18 y/o
* Agree to sign informed consent

Exclusion Criteria of Child with language disorder:

* Hearing Impairment
* Inclusion Criteria of Adult:
* His or her child participated in this study, and gene abnormality was found.

Primary outcomes:
measure: Scores of cognitive function 1
timeFrame: baseline
measure: Scores of cognitive function (2 y/o to 6 y/o)
timeFrame: baseline
measure: Scores of cognitive function (6 y/o to 16 y/o)
timeFrame: baseline
measure: Scores of cognitive function 3
timeFrame: baseline
measure: Scores of language function 1
timeFrame: baseline
measure: Scores of language function 2
timeFrame: baseline
measure: Scores of general development
timeFrame: baseline
measure: Gene test 1
timeFrame: baseline
measure: Gene test 2
timeFrame: baseline
Secondary outcomes:
measure: Scores of participation(2-5 y/o)
timeFrame: baseline
measure: Scores of participation(>6 y/o)
timeFrame: baseline
measure: Scores of activities
timeFrame: baseline
measure: Scores of quality of life
timeFrame: baseline
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memoria Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chia-Ling Chen, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06772870: A Single Ascending Dose Study of DT-216P2 in Normal Healthy Participants
Official title: A Phase 1, Double-Masked, Randomized, Placebo-Controlled, Single Ascending Dose Crossover Study to Assess the Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Intravenous DT-216P2 in Normal Healthy Participants
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Friedreich Ataxia
Lead sponsor: Design Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2025-01-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This purpose of the study is to evaluate the safety, tolerability and pharmacokinetics of single ascending doses of DT-216P2 administered either subcutaneously (SC) and intravenously (IV) in normal healthy participants. Approximately 36 participants will be enrolled into this study.


Eligibility criteria: Inclusion Criteria:

* Participants must be 18-45 years of age inclusive, at the time of signing the informed consent.
* Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and ECG.
* Agree to abstain from strenuous physical activity outside of daily norm, until end of study.
* Body mass index between 16 and 32 kg/m2 (inclusive) at screening; weight should be \<= 100 kg at screening.
* Male and/or female using protocol defined and regulatory approved contraception.
* Capable of giving signed informed consent.

Exclusion Criteria:

* Any concomitant medical condition that in the opinion of the investigator, puts the participant at risk or precludes participant from completing the study protocol.
* Any clinically significant nonmedical conditions and psychiatric disorders that could put the participant at higher risk for participation in the study, influence the participant's ability to participate in the study, or interfere with interpretation of the participant's study results, in the opinion of the investigator.
* Is not willing to comply with the contraceptive requirements during the study period, as per protocol.

Primary outcomes:
measure: Frequency of treatment emergent adverse events (TEAEs)
timeFrame: From first dose to end of study, Day 30 post first dose administration.
Secondary outcomes:
measure: Maximum Plasma Concentration (Cmax) of DT-216P2
timeFrame: Pre-dose and up to 240 hours post first dose for both SC and IV infusion.
measure: Time to Maximum Plasma Concentration (Tmax) of DT-216P2
timeFrame: Pre-dose and up to 240 hours post first dose for both SC and IV infusion.
measure: Area Under the Concentration-time Curve (AUC) of DT-216P2
timeFrame: Pre-dose and up to 240 hours post first dose for both SC and IV infusion.
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: Nucleus Network, Level 5, 89 Commercial Road
state: Victoria
Study officials:
affiliation: Nucleus Network
name: Ofer Gronen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04024670: The Impact of Arts-Based Interventions on Patient Hospital Experience
Official title: The Impact of Arts-Based Interventions on Patient Hospital Experience for Patients on a High-Risk Obstetrics and Bone Transplant Units
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Risk Pregnancy
Bone Marrow
Keywords: arts in medicine
sewing
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: nuts and bolts

Detailed description: interventions and timing of interventions

Eligibility criteria: Inclusion:

* Inpatient on either Bone Marrow Transplant ICU or High Risk Obstetrics Unit
* Estimated length of stay 2 or more weeks
* Age \>18
* Patients who will potentially benefit from the AIM experience

Additional Inclusion Criteria:

* For the High Risk Obstetrics Unit group (hand-sewing), patients should be physically able to participate in hand-sewing activity.
* For the Bone Marrow Transplant IUC group (story-telling/poetry), patients should be physically able to participate in story-telling/poetry activity.

Exclusion:

* Patient too ill
* Complex medical condition that requires therapies which would not allow time for participation
* Declined to participate
* Age \<18

Primary outcomes:
measure: Evaluate patient experience during the course of intervention using name of survey
timeFrame: Baseline at admissions
measure: Evaluate patient experience during the course of intervention using name of survey
timeFrame: Baseline - end of week 1
measure: Evaluate patient experience during the course of intervention using name of survey
timeFrame: week 1- week 2
measure: Evaluate patient experience during the course of intervention using name of survey
timeFrame: week 2 - week 3
measure: Evaluate patient experience during the course of intervention using name of survey
timeFrame: week 3 - weekly up to 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Kimberly P Kirklin, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05371470: Voice Analysis Technology to Detect and Manage Depression and Anxiety in Cardiac Rehabilitation
Official title: Evaluation of Voice Analysis Technology in Detecting and Managing Depression and Anxiety in Patients Undergoing Cardiac Rehabilitation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myocardial Infarction
Keywords: Cardiac Rehabilitation
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-05-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to learn if a voice analysis smartphone app which detects anxiety and depression could be used along with cardiac rehabilitation to improve results compared to cardiac rehabilitation alone.


Eligibility criteria: Inclusion Criteria:

* Enrolled in cardiac rehabilitation program to start within 3 months from hospital discharge.
* Owns a smartphone.
* Willing to download and use a smartphone app.
* Able to read, write, and speak English.

Exclusion Criteria:

* Actively treated for an anxiety or depressive disorder through psychotherapy or pharmacologic treatments.
* Cardiac transplant.
* Active substance use.
* Neurocognitive disorder.
* Active psychosis.
* Mania diagnosis.
* Active suicidality

Primary outcomes:
measure: Change in depressive symptoms
timeFrame: Baseline, 12 weeks
measure: Change in anxiety symptoms
timeFrame: Baseline, 12 weeks
measure: Change in perceived stress
timeFrame: Baseline, 12 weeks
measure: Change in quality of life
timeFrame: Baseline, 12 weeks
measure: Change in health behaviors
timeFrame: Baseline, 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Amir Lerman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06521970: Dynamic Posture and Head Position in Kyphotic Female and Male
Official title: Comparison of Dynamic Posture and Head Position in Kyphotic Individuals According to Gender
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kyphosis Thoracic
Postural, Thoracic Kyphosis
Postural Kyphosis
Lead sponsor: Gaziantep Islam Science and Technology University
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 54
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ADOLESCENT

Brief summary: This study examined the comparison of dynamic posture and head position in kyphotic ındividuals according to gender.

Methods: A total of 54 female and male adolescents (between the ages of 12 and 18) with a thoracic kyphosis (TK) angle of ≥ 50° were divided into two groups according to gender.

The kyphosis angle, dynamic postural performance, and forward head position were measured using a flexible ruler, Mathiass test, and occiput wall distance.

Detailed description: This study examined the comparison of dynamic posture and head position in kyphotic ındividuals according to gender.

Methods: This observational cross-sectional study was conducted with 54 subjects. Subjects aged 12 to 18 years with a kyphosis angle of ≥50º and the children and their parents who agreed to participate in the study were included. Individuals with Scheurmann kyphosis, scoliosis (Cobb angle \>10°), and other congenital spine abnormalities were excluded.

The kyphosis angle was measured using a smartphone inclinometer. Dynamic posture was assessed using the Matthias test. Head position was obtained using occiput-wall distance.

Eligibility criteria: Inclusion Criteria:

* Subjects with a kyphosis angle of ≥50º and the children and their parents who agreed to participate in the study were included.

Exclusion Criteria:

* Individuals with Scheurmann kyphosis, scoliosis (Cobb angle \>10°), and other congenital spine abnormalities were excluded.

Primary outcomes:
measure: Matthias test
timeFrame: 1 year
Secondary outcomes:
measure: Occiput wall distance
timeFrame: 1 year
Other outcomes:
Locations:
city: Gaziantep
country: Turkey
facility: Gaziantep Islam Science and Technology University
Study officials:
affiliation: Gaziantep Islam Science and Technology University Physical Therapy and Rehabilitation Department
name: Gonul Elpeze, Asst. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01039870: The Effect of Paravertebral Block Using a Multi-orifice Catheter on Preventing Acute and Chronic Post-thoracotomy Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Postthoracotomy Pain
Chronic Postthoracotomy Pain
Hypotension After Bolus Dose
Keywords: postthoracotomy pain
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2009-12-25
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the effect of the paravertebral block using a multi-lumen catheter on the incidence and severity of acute and chronic postthoracotomy pain compared to the thoracic epidural block.


Eligibility criteria: Inclusion Criteria:

* patients receiving surgery through a thoracotomy incision

Exclusion Criteria:

* patients with cardiovascular disease
* patients with neurologic disease
* patients with contraindications to paravertebral block or epidural block
* patients with history of previous thoracotomy incision
* patients with pain at the expected incision site

Primary outcomes:
measure: Incidence and severity of acute postthoracotomy pain when moving
timeFrame: 24 hours after thoracotomy
Secondary outcomes:
measure: Incidence of chronic postthoracotomy pain
timeFrame: 6 months after thoracotomy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: