louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05620849: Young Adult Education on Alcohol & Health
Official title: A Technology-based Intervention for Alcohol-related Sexual Risk Behaviors in Young Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sexual Behavior
Alcohol Drinking
Condomless Sex
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-11-17
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to test the effectiveness of our brief online program when compared to those who don't complete the program at all.

Detailed description: A total of 300 participants will complete this 6 month study. The study will include a background survey, 5 week monitoring period where participants either complete the brief online program with check-in surveys or check-in surveys only, and follow-up surveys 1, 3, and 6 months later.

Eligibility criteria: Inclusion Criteria:

* Assessed as part of screening procedures

Exclusion Criteria:

* Do not want to participate

Primary outcomes:
measure: Drinking before sex (frequency)
timeFrame: Follow up (1 month, 3 month, 6 months)
measure: Drinking before sex (quantity)
timeFrame: Follow up (1 month, 3 month, 6 months)
measure: Condomless sex
timeFrame: Follow up (1 month, 3 month, 6 months)
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Jessica Blayney, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02478749: Influence of Arm Retraction on the Supraclavicular Approach for Subclavian Vein Catheterization
Official title: Influence of Arm Retraction on the Relative Position of Clavicle and the Subclavian Vein,During Supraclavicular Approach for Central Venous Catheterization in Adults and Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subclavian Venous Catheterization
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-06-23
Enrollment: 60
Sex: ALL
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The purpose of this study is to determine the effect of arm retraction on the supraclavicular approach for subclavian vein catheterization in adults and children.


Eligibility criteria: Inclusion Criteria:

* patients undergoing general anesthesia regardless of subclavian venous catheterization

Exclusion Criteria:

* patients with infection over the puncture site history of thoracic surgery or clavicular fracture vascular malformation anatomical abnormality of subclavian vein

Primary outcomes:
measure: Change of distance between clavicle and confluence of internal jugular vein and subclavian vein while arm retraction
timeFrame: Outcome measure will be assessed during arm retraction and it would be within 30 second of arm retraction
measure: Change in diameter of suvclavian vein at the confluence of internal jugular vein and subclavian vein
timeFrame: Outcome measure will be assessed during arm retraction and it would be within 30 second of arm retraction
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jintae Kim, MD.PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim EH, Lee JH, Song IK, Kim HC, Kim HS, Kim JT. Influence of caudal traction of ipsilateral arm on ultrasound image for supraclavicular central venous catheterization. Am J Emerg Med. 2016 May;34(5):851-5. doi: 10.1016/j.ajem.2016.01.038. Epub 2016 Feb 12.
Clinical trial NCT04355949: Assessment of Serum Levels of Vitamin D, Vitamin B12 and Folic Acid Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.
Official title: Vitamin D, Vitamin B12, and Folic Acid Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin D, Vitamin B12 and Folic Acid Among Patients With Premature Ejaculation
Keywords: Premature Ejaculation
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 60
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: assess serum levels of vitamin D, vitamin B12 and folic acid among patients with lifelong PE and non-responding to dapoxetine treatment.
Primary purpose: DIAGNOSTIC

Brief summary: Therefore, this study will aim to assess serum levels of vitamin D, vitamin B12 and folic acid among patients with lifelong PE and non-responding to dapoxetine treatment.

Detailed description: We will consider the patients with LPE non-responding to dapoxetine treatment when they used the optimum dose (30 and 60mg) dapoxetine for 4 separate times with no response.

Serum vitamin D, vitamin B12, and folic acid levels will be assessed in all subjects included in the study. Venous blood samples will be drawn and kept into EDTA bottles in the morning between 8 and 10 a.m. after an overnight fast of about 10-14 hr.

Eligibility criteria: Inclusion Criteria:

* premature ejaculation
* non-responding to dapoxetine treatment.

Exclusion Criteria:

* diabetes mellitus,
* chronic prostatitis,
* Advanced renal or hepatic diseases
* neurological diseases and
* C.N.S. medications

Primary outcomes:
measure: Serum vitamin D in patient with PE
timeFrame: 0-1 week
measure: vitamin B12, in patient with PE
timeFrame: 0-1 week
measure: folic acid in patient with PE
timeFrame: 0-1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of Medicine, Sohag University, Egypt
Study officials:
affiliation: Dermatology, Venereology and Andrology, Faculty of Medicine, Sohag University
name: Mohammed Abu El-Hamd, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00561249: Randomized Prospective Trial on the Use of Laser Assisted Hatching (LAH) for Transfer of Frozen/Thawed Embryos in Human IVF/ICSI
Official title: Randomized Prospective Trial on the Use of Laser Assisted Hatching (LAH) for Transfer of Frozen/Thawed Embryos in Human IVF/ICSI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: IVF
ICSI
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2007-11-20
Enrollment: 293
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: At the time of transfer of frozen/thawed embryos in human IVF/ICSI, patients are randomized between study and control group.In the control group no additional intervention takes place on the embryos to be transferred,in the study group, embryos for transfer are subjected to laser assisted hatching(LAH) following the standard procedure.The LAH procedure lasts two minutes per embryo.


Eligibility criteria: Inclusion Criteria:

* 18 years old and above
* Female

Exclusion Criteria:

* No exclusion criteria, except not possible to give informed consent

Primary outcomes:
measure: clinical implantation per transferred embryo
timeFrame: fourteen days after transfer
Secondary outcomes:
measure: clinical pregnancy and birth per transfer
timeFrame: resp. 12 weeks and 38 weeks after transfer
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Petra De Sutter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06641349: Effect of Maternal Supplementation From Preconception to Lactation on Child Growth and Development
Official title: Effect of Maternal Multiple Micronutrient Supplementation From Preconception Through Lactation on Child Growth and Development in Rural Pakistan: A Follow-up Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Malnutrition
Growth &Amp; Development
Keywords: malnutrition
multiple micronutrient supplement
neurodevelopment
growth
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Aga Khan University
First posted: 2024-10-15
Enrollment: 186
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residence within Matiari District, Pakistan

Brief summary: The goal of this observational study is to learn about the long-term effects of maternal multiple micronutrient supplementation from preconception through to lactation on child neurodevelopment and growth in a resource-limited setting where there is a high burden of malnutrition. The main questions it aims to answer are:

* Does maternal multiple micronutrient supplementation from preconception through to lactation compared to the standard of care have an effect on child neurodevelopment?
* Does maternal multiple micronutrient supplementation from preconception through to lactation compared to the standard of care have an effect on child growth?

This is a cross-sectional follow up study to a substudy of breastmilk composition and infant growth within the Matiari emPowerment and Preconception Supplementation (MaPPS) Trial, wherein mothers were randomized to receive a multiple micronutrient supplement from preconception through to lactation or the standard of care (ClinicalTrials.gov Identifier: NCT04451395).


Eligibility criteria: Inclusion Criteria:

* Child participated in the MaPPS Trial Breastmilk Sub-study at 3-months of age
* Child has reached their fourth birthday
* Child is available in the study catchment area (Matiari District)

Primary outcomes:
measure: Full scale IQ score
timeFrame: At 4 years of age
Secondary outcomes:
measure: Fine and gross motor skills score
timeFrame: At 4 years of age
measure: Height
timeFrame: At 4 years of age
measure: Head circumference
timeFrame: At 4 years of age
Other outcomes:
measure: Weight
timeFrame: At 4 years of age
measure: Middle upper arm circumference
timeFrame: At 4 years of age
Locations:
city: Matiari
country: Pakistan
facility: Aga Khan University
Study officials:
References:
Clinical trial NCT02946749: Abnormal Placenta Plant Disease Early Diagnosis and Individualized Treatment Research
Official title: Abnormal Placenta Plant Disease Early Diagnosis and Individualized Treatment Research
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Scarred Uterus
Keywords: Scar pregnancy
Placenta planting abnormal disease
Early diagnosis
Individualized treatment
Lead sponsor: Shanghai First Maternity and Infant Hospital
Sponsor class: OTHER
First posted: 2016-10-27
Enrollment: 3000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women with scar uterus

Brief summary: As the "two-child" policy implementation, caesarean women's clinical pregnancy is a huge problem again, Especially the placenta planting abnormal disease is a serious threat to the maternal health and life. Through this research, the investigators can obtain relevant epidemiological data and provide objective data for the department of public health policy; Predicting an placenta abnormal planting early diagnosis model was constructed, it will fill the blank in this field, and high-risk groups in the early stages of pregnancy will be taken proper disposal, the related complications will be reduced to ensure the safety of maternal.

Detailed description: This study focus on four hands: (1) to investigate different types of gestational sac implantation for pregnancy in caesarean women of childbearing age;(2) to explore the relationship between abnormal placenta planting disease in middle-late pregnancy and the different types of scar pregnancy (3) to explore the the value of ultrasound and serological markers for early diagnosis of placenta planting disease from scar pregnancy; (4) to compare the end and the influence of health economy of different termination method on scar pregnancy.

Eligibility criteria: Inclusion Criteria:

* Single pregnancies with once cesarean section history
* see a doctor before gestational 8 weeks in our study center
* will continue to pregnancy, high patient compliance

Exclusion Criteria:

* twins or multiple pregnancies
* hysteromyoma or adenomyoma stripping history
* history of intrauterine adhesions

Primary outcomes:
measure: Placenta implanted
timeFrame: up to 37 gestational weeks
Secondary outcomes:
measure: Placenta previa
timeFrame: up to 37 gestational weeks
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai First Maternity and Infant Hospital
name: Hao Ying, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01754649: Use of Misoprostol in Case of Insertion Failure of Intrauterine Contraceptives
Official title: Assessment of Use of Misoprostol to Facilitate the Insertion of Intrauterine Contraceptives After Failure of Insertion. A Randomized Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cervical Stenosis
Keywords: intrauterine device
insertion failure
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2012-12-21
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the usefulnes sof misoprostol versus placebo (in a double-blind placebo controlled randomized clinical trial)to facilitate the insertion of copper-IUD and the levonorgestrel-releasing intrauterine system (LNG-IUS) in cases of failure due to cervical stenosis in either nulligravidas and parous women. Additionally to evaluate the side-effects of the misoprostol. The hypothesis is that misoprostol may be better than placebo.

Detailed description: Women attended at the Family Planning clinic of the University of Campinas who requested the insertion of a copper-IUD or an LNG-IUS and who failed in the attempt due to cervical stenosis will be randomized in two groups (1:1). The study group will receive two doses of misoprostol (200mcg each tablet) vaginal 12 and 4 hours prior insertion and the control group will receive placebo in the same schedule. The sample will be 50 women in each group. After 24 hours of the insertion failure the women will return to the clinic and a new attempt of insertion will be done. At this time we will evaluate if the insertion was able to do or not. The data will be analyzing with χ2 test for independent samples. After that a multiple logistic analysis will be perform to evaluate the associated variables with the result (failure or successful) insertion. The level of significance will be established at P\<.005.

Eligibility criteria: Inclusion Criteria:

Women aged \> 18 and \<50 years old; Requesting insertion of and IUD or an LNG-IUS Failure of IUD insertion

Exclusion Criteria:

Refuse to participate Lost to follow-up at the return visit

Primary outcomes:
measure: ease of insertion of intrauterine contraceptives
timeFrame: 12 months
Secondary outcomes:
measure: Side-effects of misoprostol
timeFrame: 12 months
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: Family Planning Clinic, University of Campinas
state: SP
city: Campinas
country: Brazil
facility: University of Campinas
state: SP
Study officials:
References:
citation: Bahamondes MV, Espejo-Arce X, Bahamondes L. Effect of vaginal administration of misoprostol before intrauterine contraceptive insertion following previous insertion failure: a double blind RCT. Hum Reprod. 2015 Aug;30(8):1861-6. doi: 10.1093/humrep/dev137. Epub 2015 Jun 3.
Clinical trial NCT04316949: Predictors of Respiratory Failure in SARS-Cov-2 Infection
Official title: Predictors of Respiratory Failure Requiring ICU Admission Among Hospitalized Patients With SARS-Cov-2 Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV-2 Pneumonia
Lead sponsor: University of Bologna
Sponsor class: OTHER
First posted: 2020-03-20
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population of the study will include all consecutive hospitalized patients with microbiologically confirmed diagnosis of SARS-CoV-2 infection

Brief summary: The emergence of SARS-CoV-2 is currently engaging and consuming most of resources of efficient healthcare systems in Europe, and several hospitals are currently experiencing a shortage of ICU beds for critically-ill patients with SARS-CoV-2 pneumonia.

A risk stratification based on clinical, radiological and laboratory parameters seems necessary in order to better identify those patients who may need ICU admission and/or those who may benefit from a prompt antiviral therapy

Detailed description: The study will compared patients with and without respiratory failure in order to find risk factors for need for ICU admission. A simple score based on risk factors will be created from a multicenter Italian cohort and validated in a multicenter international cohort.

Eligibility criteria: Inclusion Criteria:

* Hospitalized patients with microbiologically confirmed diagnosis of SARS-CoV-2 infection
* Age \> 17 years

Exclusion Criteria:

* Invasive mechanical ventilation within 12 hours from hospital admission

Primary outcomes:
measure: Respiratory failure
timeFrame: 14 days
Secondary outcomes:
measure: Occurence of bacterial superinfection
timeFrame: 14 days
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: University of Bologna - Department of Medical and Surgical Sciences
Study officials:
References:
citation: Bartoletti M, Giannella M, Scudeller L, Tedeschi S, Rinaldi M, Bussini L, Fornaro G, Pascale R, Pancaldi L, Pasquini Z, Trapani F, Badia L, Campoli C, Tadolini M, Attard L, Puoti M, Merli M, Mussini C, Menozzi M, Meschiari M, Codeluppi M, Barchiesi F, Cristini F, Saracino A, Licci A, Rapuano S, Tonetti T, Gaibani P, Ranieri VM, Viale P; PREDICO study group. Development and validation of a prediction model for severe respiratory failure in hospitalized patients with SARS-CoV-2 infection: a multicentre cohort study (PREDI-CO study). Clin Microbiol Infect. 2020 Nov;26(11):1545-1553. doi: 10.1016/j.cmi.2020.08.003. Epub 2020 Aug 8.
Clinical trial NCT01839149: TI-001 (Intranasal Oxytocin) for Treatment of High Frequency Episodic Migraine and Chronic Migraine
Official title: A Phase 2, Enriched-enrollment, Randomized-withdrawal, Double-blinded, Placebo-Controlled Study to Assess the Efficacy, Tolerability, and Safety of Intranasal Oxytocin in Subjects With Chronic Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: High Frequency Episodic Migraine and Chronic Migraine
Keywords: Refractory Chronic Migraine
Medically Intractable Chronic Migraine
Oxytocin
Intranasal oxytocin
Lead sponsor: Trigemina, Inc
Sponsor class: INDUSTRY
First posted: 2013-04-24
Enrollment: 240
Sex: ALL
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 evaluates the use of oxytocin, given as a nasal spray, for treatment of high frequency episodic migraine and chronic migraine.


Eligibility criteria: Inclusion Criteria:

1. Men and women, aged 18 to 65 years with primary diagnosis of high frequency episodic migraine or chronic migraine.

Exclusion Criteria:

1. Known allergy to oxytocin
2. History of addictive behavior (eg, alcoholism, drug abuse) or severe mood disorder
3. History of clinically significant, functionally impairing cardiovascular or pulmonary disease or any other disease that might confound study results
4. Have basilar or hemiplegic migraines
5. Have substantial cognitive or memory impairment due to any cause (eg, Alzheimer's or dementia)
6. Have a nasal obstruction due to any cause
7. Are pregnant or breast feeding
8. Require ongoing use of steroidal or nonsteroidal anti-inflammatory drugs
9. Are unable or unwilling to provide informed consent or to follow study procedures

Primary outcomes:
measure: Mean change of migraine days
timeFrame: Baseline and 28 days of treatment
Secondary outcomes:
measure: Mean change of moderate or severe headache days
timeFrame: Baseline and 28 days of treatment
measure: Proportion of subjects experiencing a ≥50% reduction in migraine days
timeFrame: Baseline and 28 days of treatment
measure: Mean change in days using rescue medication
timeFrame: Baseline and 28 days of treatment
measure: Proportion of subjects experiencing a reduction in headache severity and pain score 2 hours after dosing
timeFrame: Baseline and 28 days of treatment
Other outcomes:
Locations:
city: Fitzroy
country: Australia
city: Prahran
country: Australia
city: Sherwood
country: Australia
city: Santiago
country: Chile
city: Tauranga
country: New Zealand
city: Wellington
country: New Zealand
Study officials:
affiliation: Trigemina, Inc
name: Raquel Izumi, PhD
role: STUDY_DIRECTOR
References: