louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04464005: Comparison Between Pads With Cold Solution of Magnesium Sulfate or Cold Water Postpartum Perineal Pain and Healing
Official title: Comparison Between Pads With Cold Solution of Magnesium Sulfate or Cold Water to Treat Pain and Improve Healing of the Perineum After Vaginal Delivery. A Prospective, Randomized, Double-blind Controlled Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Women After Delivery With Perineal Pain
Lead sponsor: The Baruch Padeh Medical Center, Poriya
Sponsor class: OTHER_GOV
First posted: 2020-07-09
Enrollment: 140
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: Perineal pain after delivery is common and is caused by local bruising or episiotomy. The pain may last for several days or months. Thus, several analgesic methods are offered. Topical magnesium sulfate 33% solution is a common treatment for perineal pain, wound treatment and alleviation of swelling. Yet, the efficacy of this treatment was not tested sufficiently in a clinical trials.

In the present study we will compare the efficacy of topical magnesium sulfate versus cold water for perineal pain and improved perineal healing after delivery.

Women after vaginal delivery (spontaneous or operative) with pain score of 3 in 0-10 numeric rating scale (NRS) will randomly be allocated to receive either pad with cold magnesium sulfate 33% solution or cold water. Pain score and healing parameters will be assessed at baseline, after one day of treatment and after two days of treatment.


Eligibility criteria: Inclusion Criteria:

* Woman after spontaneous or operative vaginal delivery
* Perineal pain score of at least 2 NRS

Exclusion Criteria:

* Women after cesarean delivery
* Refuse to participate
* Under 18 years of age
* Magnesium sulfate treatment not related to the study
* Contraindication for magnesium sulfate treatment
* Workers of the local obstetric department

Primary outcomes:
measure: Rate of women with perineal pain score< 3 NRS at the day after treatment initiation
timeFrame: 24 hours post enrollment
measure: Perineal pain intensity according to NRS scale at the day after treatment initiation
timeFrame: 24 hours post enrollment
Secondary outcomes:
measure: Degree of perineal healing using the REEDA scale
timeFrame: 2 days
measure: Perineal pain intensity according to NRS scale two days after treatment initiation
timeFrame: 2 days (if still in hospital)
measure: Rate of women with improvement in hemorrhoids characteristics in women with hemorrhoids
timeFrame: 2 days
Other outcomes:
Locations:
city: Tiberias
country: Israel
facility: Baruch Padeh Medical center, Poriya
state: North
Study officials:
References:
Clinical trial NCT03171805: The Use of Propranolol for the Prevention of Worsening of Esophageal Varices in Patients With Isolated Gastric Varices
Official title: Post-balloon Occluded Retrograde Transvenous Obliteration Use of Propranolol for the Prevention of Worsening of Esophageal Varices in Patients With Isolated Gastric Varices
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cirrhoses
Portal Hypertension
Gastric Varix
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Balloon-occluded retrograde transvenous obliteration (BRTO) has been effective method to manage gastric varices. However, more than one third of patients after BRTO treatment experienced worsening of esophageal varices. The present study was designed to evaluate the effect of post-BRTO propranolol adminstration on the change of esophageal varices.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of liver cirrhosis
2. Clinical diagnosis of isolated gastric varices
3. The presenec of spontaneous portosystemic shunt

Exclusion Criteria:

1. Contradictions to Propranolol
2. Balloon occluded retrograde transvenous obliteration was failed

Primary outcomes:
measure: Worsening of esophageal varices rate
timeFrame: 3 years
Secondary outcomes:
measure: Variceal rebleeding rate
timeFrame: 3 years
measure: Mortality rate
timeFrame: 3 years
measure: Worsening of ascites rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West china Hospital
Study officials:
affiliation: Sichuan University
name: xuefeng luo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03110705: Recreational Diving Practice for Stress Management
Official title: Recreational Diving Practice for Stress Management: an Exploratory Controlled Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychological Stresses
Lead sponsor: Institut de Recherche Biomedicale des Armees
Sponsor class: OTHER_GOV
First posted: 2017-04-12
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: middle-class populations registered at a leisure sports club were included: one population sample registered for a one-week recreational scuba diving course (37 subjects, diving group) and one population sample registered for a one-week multisport course (30 subjects, control group).

Brief summary: Within the components of Scuba diving there are similarities with meditation and mindfulness techniques. Perceived stress is known to be diminished during meditation practice. This study evaluates the benefits of scuba diving on perceived stress and mindful functioning.

Detailed description: Background: within the components of Scuba diving there are similarities with meditation and mindfulness techniques. Perceived stress is known to be diminished during meditation practice. This study evaluates the benefits of scuba diving on perceived stress and mindful functioning.

Method: A recreational diving group, composed of 37 subjects, was compared with a multisport control group, composed of 30 subjetcs, on perceived stress, mood, well-being and mindfulness by answering auto-questionnaires before and after a one-week long course. For the diving group, stability of the effects was evaluated one month later using similar auto-questionnaires.

Eligibility criteria: Inclusion Criteria:

* More than 18
* registered at a leisure sports club

Exclusion Criteria:

* they were undergoing medical treatment for psychological issues at the time of the study
* they had taken part in a stress management program prior to recruitment for the current study

Primary outcomes:
measure: perceived stress
timeFrame: change from baseline after one week sport (e.g. baseline and one week)
Secondary outcomes:
measure: mindfulness
timeFrame: change from baseline after after one week sport (e.g. baseline and one week)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05146505: miRNAs in High Grade Serous Ovarian Cancer
Official title: Analysis of Circulating miRNAs as Potential Biomarkers of Diagnosis and Prognosis in High Grade Serous Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: High Grade Serous Ovarian Cancer
Keywords: miRNAs
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2021-12-06
Enrollment: 150
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with high grade serous ovarian cancer

Brief summary: High grade serous ovarian cancer represents the gynecological malignancy with the highest incidence of mortality. Decision-making tools are currently limited to the use of standard imaging modalities and analysis of serum biomarkers, such as CA 125, which often have low specificity and sensitivity. Recently, a growing research interest has been aimed at so-called circulating microRNAs (miRNAs). Indeed, it has been observed that miRNAs are abundantly present in all biological fluids and play the key role of messengers in intercellular communication. Cancer cells have a rapid turnover which results in a continuous release of nucleic acids and vesicles derived from the tumor itself, such as the tumor cells themselves that separate from the tumor mass to enter the bloodstream. Given their important role as modulators of gene expression, in order to preserve their integrity, miRNAs are encapsulated in specific vesicles, in order to prevent their degradation by the enzymes present in biological fluids. In this context, the chance of monitoring the expression levels of specific miRNAs represents a very interesting option both for an early diagnosis and for monitoring the clinical response to pharmacological treatment. Currently, there are no non-invasive approaches to monitor the clinical outcome in real time, while the identification of circulating biomarkers would allow prompt intervention, possibly modifying the pharmacological management in case of progression.


Eligibility criteria: Inclusion Criteria:

* age\>18
* Histological diagnosis of epithelial ovarian cancer
* Patients eligible for surgery
* Patients followed in the clinical care pathway c / o oncological gynecology (surgery and follow up)
* informed consent

Exclusion Criteria:

* Patients with HCV, HBV and HIV
* Patients with other malignancies diagnosed less than 5 years prior to the diagnosis of ovarian malignancy
* Ovarian metastases of primary neoplasms of other organs
* Presence of ascites for non-neoplastic causes

Primary outcomes:
measure: Longitudinal miRNAs analysis over chemotherapy
timeFrame: 2 years
Secondary outcomes:
measure: Associaition miRNA-clinico-pathological data
timeFrame: 2 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS- Azienda Ospedaliera-Universitaria di Bologna
state: Bo
Study officials:
affiliation: IRCCS Azienda Ospedaliera-Universitaria di Bologna
name: Anna Myriam Perrone
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02068105: A Study of ALKS 5461 in Healthy Volunteers
Official title: A Phase 1, Randomized, Two-part Study to Evaluate the Relative Bioavailability of Two Formulations of ALKS 5461 and the Effect of Dose Titration of ALKS 5461 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pharmacokinetics
Keywords: ALKS 5461
samidorphan
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2014-02-21
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a study to test the safety of ALKS 5461 in healthy adults.


Eligibility criteria: Inclusion Criteria:

* Be in good physical health
* Body mass index of 18-30 kg/m2
* Agree to use an approved method of birth control for the duration of the study
* Additional criteria may apply

Exclusion Criteria:

* Currently pregnant or breastfeeding
* History of or current infection with Hepatitis B Virus, Hepatitis C Virus or Human Immunodeficiency Virus (HIV)
* Current or history of any clinically significant medical or psychiatric condition
* Current abuse or dependence on alcohol or any illicit drugs
* Have used nicotine within 90 days
* Have used St. John's Wort or consumed grapefruit, grapefruit juice, or juices containing grapefruit within 30 days
* Have used any prescription or over-the-counter medication, including natural health products (with the exception of prescription birth control or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days
* Have used opioids 30 days prior to screening or have an anticipated need for opioid medication at any point during the study
* Have a history of intolerance or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)
* Additional criteria may apply

Primary outcomes:
measure: Relative bioavailability of ALKS 5461 treatment groups
timeFrame: 21 days
Secondary outcomes:
measure: Safety and tolerability: Incidence of adverse events
timeFrame: 21 days
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Alkermes Investigational Site
state: Kansas
Study officials:
affiliation: Alkermes, Inc.
name: Randall Marshall, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03067805: Influence of Oxytocin on Romantic Jealousy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Infidelity
Emotional Infidelity
Jealousy
Keywords: Oxytocin effect
romantic jealousy
Arousal Rating
Jealousy Rating
Lead sponsor: University of Electronic Science and Technology of China
Sponsor class: OTHER
First posted: 2017-03-01
Enrollment: 140
Sex: ALL
Minimum age (years): 17
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim is to evoke romantic jealousy between couples and investigate whether oxytocin has effect on it.

Detailed description: In a double-blind, between- subject placebo (PLC) controlled design,investigators plan to test the effect of intranasal oxytocin on romantic jealousy evoked by the Imaginary of Partner's Infidelity Task and Cyberball Game in romantically attached subjects.

Eligibility criteria: Inclusion Criteria:

* healthy couples in romantic relationship for more than 3 months and have intimate experience with each other before.

Exclusion Criteria:

* medical or psychiatric illness

Primary outcomes:
measure: Arousal and jealousy ratings as assessed by Likert Scales
timeFrame: 145 Minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: School of Life Science and Technology, University of Electronic Science and Technology
state: Sichuan
Study officials:
affiliation: University of Electronic Science and Technology of China
name: Keith Kendrick, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06889805: HDV Screening Study
Official title: Universal Screening for Hepatitis Delta Virus (HDV) in Individuals Living with HIV/HBV Coinfection and HBV-related HCC
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis D Virus Infection
Keywords: HDV
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2025-03-21
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals living with HIV/HBV coinfection and HBV-related HCC

Brief summary: This is a territory-wide cross-sectional study of all individuals living with HIV/HBV coinfection and HBV-related HCC.

Detailed description: Chronic hepatitis B virus (HBV) infection remains endemic in Hong Kong with an estimated prevalence of 6.2% in the recent Population Health Survey 2020-2022.1 The estimated prevalence of chronic HBV infection among individuals living with HIV is 8%.2 Yet, no data are available concerning the disease burden of hepatitis delta virus (HDV) among individuals living with HIV/HBV coinfection.

Eligibility criteria: Inclusion Criteria:

1. Individuals with HIV infection, i.e. anti-HIV or HIV RNA positive; AND
2. Individuals with chronic hepatitis B, i.e. hepatitis B surface antigen (HBsAg) or HBV DNA positive for two times at least 6 months apart; AND
3. Aged 18 years old or above.
4. Written or verbal consent obtained

Exclusion Criteria:

1. Refusal to consent
2. Age \< 18 years

Primary outcomes:
measure: Rate of positive anti-HDV
timeFrame: at screening
Secondary outcomes:
measure: Prevalence rate of detectable HDV RNA
timeFrame: at screening
measure: Prevalence rate of compensated advanced chronic liver disease
timeFrame: at screening
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Lai Hung Grace Wong
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lai JC, Wong GL, Wong VW, Yip TC. Unmet need in screening for hepatitis D virus: Time to take action. J Hepatol. 2024 Jun;80(6):e277-e278. doi: 10.1016/j.jhep.2023.12.006. Epub 2023 Dec 16. No abstract available.
citation: Lui GC, Wong GL, Yang HC, Sheng WH, Lee SH. Current practice and recommendations for management of hepatitis B virus in people living with HIV in Asia. HIV Med. 2023 Oct;24(10):1035-1044. doi: 10.1111/hiv.13545. Epub 2023 Sep 21.
Clinical trial NCT00097305: Body-Oriented Therapy for Sexual Abuse Recovery
Official title: Delving Intervention and Mindbody Integration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Child Abuse, Sexual
Post-Traumatic Stress Disorder
Dissociation
Keywords: Mental Health
Psychotherapy
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2004-11-22
Enrollment: 24
Sex: FEMALE
Minimum age (years): 25
Standard ages: 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 and compare the effects of two body therapy approaches in women who have experienced child sexual abuse.

Detailed description: Women who have experienced child sexual abuse often display symptoms of dissociation and lack of bodily self-awareness which hinder the recovery process. Mind-body researchers have examined alternative therapeutic approaches to eliminating these factors. This study will compare a standardized therapeutic message to body-oriented therapy which involves a combination of hands-on bodywork and verbal therapy focused on somatic and emotional awareness.

Eligibility criteria: Inclusion Criteria:

* Self-reported child sexual abuse
* In current psychotherapy for child sexual abuse recovery

Exclusion Criteria:

* Over 6 months of past experience with body-oriented therapy
* Diagnosis or medications for psychosis
* Drug or alcohol addiction
* Current abusive relationship
* Dissociative disorder
* In transition on psychotropic medication

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington School of Nursing
state: Washington
Study officials:
affiliation: Assistant Professor, University of Washington School of Nursing
name: Cynthia Price, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Price, C. Characteristics of women seeking bodywork as an adjunct to psychotherapy during recovery from childhood sexual abuse. Journal of Bodywork and Movement Therapies, 8(1): 35-42, 2004.
citation: Price, C. Body-oriented therapy as an adjunct to psychotherapy in recovery from childhood abuse: A case study. Journal of Bodywork and Movement Therapies, 6(4): 228-236, 2002.
citation: Price C. Bodywork for childhood abuse treatment: a pilot-test comparison. 35th Annual Communicating Nursing Research Conference/16th Annual WIN Assembly, Health Disparities: Meeting the Challenge, April 18-20, 2002, Palm Springs, California. Communicating Nursing Research. 35(10):264, 2002.
Clinical trial NCT01919905: Mozzarella Cheese Vitamin D and Bioavailability
Official title: Fortification of Mozzarella Cheese With Vitamin D3: Effect of High Temperature Cooking and Bioavailability of Vitamin D3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Change in Serum 25 Hydroxyvitamin D Levels
Keywords: Mozzarella cheese fortification
Bioavailability of Vitamin D
Lead sponsor: University of Toronto
Sponsor class: OTHER
Collaborators: name: Toronto Metropolitan University
name: George Brown College
First posted: 2013-08-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate the effect of heat on the bioavailability of vitamin D in industrially fortified mozzarella cheese baked with pizza.

Detailed description: With a growing body of evidence, the Institute of Medicine (IOM) conducted a thorough review of all available evidence to publish a report on Dietary Reference Intakes (DRIs) for calcium and vitamin D. In the absence of adequate sun exposure, acquiring the new RDA of 600-800 IU/d for vitamin D through diet alone is difficult. There is a need to increase dietary sources of vitamin D for Canadians.

In a double blind, randomized trial, our objective was to assess the effect of high temperature pizza baking on the bioavailability of vitamin D3 fortified Mozzarella cheese. We tested the following hypotheses, set a priori: 1) vitamin D3 is bioavailable from pizza baked with fortified Mozzarella cheese and heat does not significantly break down vitamin D3; and 2) the change in serum 25(OH)D (from baseline to 10 wk) will be significantly greater in the high-dose vitamin D treated group (28000 IU/wk) compared to the low dose vitamin D-treated group (200 IU/wk).

Eligibility criteria: Inclusion Criteria:

* Healthy males and females between ages 18-70 years

Exclusion Criteria:

* Use of vitamin D supplements in excess of 1000 IU/day
* A history of any medical disorder that might effect vitamin D or mineral metabolism
* Use of medications that could interfere with vitamin D metabolism
* Potential for sun exposure ( i.e travel to a sunny destination of use of tanning beds) within the month prior to or during the study
* History of hypercalcemia
* Unwillingness to return for follow up

Primary outcomes:
measure: Bioavailability of vitamin D fortified Mozzarella cheese after pizza baking
timeFrame: 2 months
Secondary outcomes:
measure: Monitoring dose safety
timeFrame: 2 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: George Brown College
state: Ontario
Study officials:
affiliation: Mount Sinai Hospital, Canada
name: Reinhold Vieth, Phd
role: PRINCIPAL_INVESTIGATOR
References: