louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02813993: Couples Fertility and Pregnancy Awareness
Official title: Couples Fertility and Pregnancy Awareness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fertility; Decision to Get Pregnant
Keywords: infertility
fertility awareness
preconceptional care
health interventions
couples
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
First posted: 2016-06-27
Enrollment: 244
Sex: ALL
Minimum age (years): 24
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Recent evidence has shown that young people that want to have children have low fertility knowledge. This study evaluates the efficacy of a video intervention on fertility knowledge, on changes in lifestyle and on the decision to start to get pregnant.

Detailed description: This study will compare the efficacy of a video intervention versus control (no video) in couples that intend to have children in the next three years. The couples will be randomized to the two groups. The video contains information concerning age-related fertility decline, fertility risk factors, the success of infertility treatments, and emotional consequences of childlessness.

Eligibility criteria: Inclusion Criteria:

* Female member of the couples has between 24 to 40 years
* Childless couples trying to conceive or couples who desired to have children in the next 3 years
* Relationship length minimum of one year

Exclusion Criteria:

* Couples that already had achieved a successful pregnancy
* Couples with children

Primary outcomes:
measure: Change in Fertility knowledge
timeFrame: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later
Secondary outcomes:
measure: Change in number of months planned to get pregnant/pregnancy
timeFrame: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later
measure: Change in intention and adoption of fertility-optimizing behaviors
timeFrame: T0 - before the intervention; T1 - one month later; T2 - six months later; T3 - one year later
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: University of Porto, Faculty of Psychology and Educational and Education Sciences
Study officials:
affiliation: Universidade do Porto
name: Juliana Pedro, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06011993: Real-world Analysis on the Efficacy and Safety of Neoadjuvant Therapy for Head and Neck Squamous Cell Carcinoma （neoHNSCC）
Official title: Real-world Analysis on the Efficacy and Safety of Neoadjuvant Therapy for Head and Neck Squamous Cell Carcinoma （neoHNSCC）
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: HNSCC
Neoadjuvant immunochemotherapy
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-08-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Head and neck squamous cell carcinoma，HNSCC

Brief summary: This is a retrospective, single-arm study that assesses the efficacy and safety of neoadjuvant immunotherapy combined with platinum-based chemotherapy for Head and Neck Squamous Cell Carcinoma. This trial will also explore the biomarkers of neoadjuvant immunochemotherapy.

Detailed description: This is a retrospective, single-arm study that assesses the efficacy and safety of neoadjuvant immunotherapy combined with platinum-based chemotherapy for Head and Neck Squamous Cell Carcinoma. This trial will also explore the biomarkers of neoadjuvant immunochemotherapy. Patients with untreated, operable, or potentially resectable HNSCC will be included.The pathological results, adverse events and other information of eligible patients will be collected.

Eligibility criteria: Inclusion Criteria:

* Age 18-80, male or female；
* Cytologically or histologically diagnosed squamous cell carcinoma (except mixed squamous cell carcinoma)；
* There was at least one radiographically measurable lesion according to the solid tumor response Evaluation Criteria (RECIST version 1.1)；
* Patients with untreated, operable, or potentially resectable head and neck squamous cell carcinoma；

Exclusion Criteria:

* Malignant diseases other than head and neck squamous cell carcinoma diagnosed within 5 years prior to first administration (excluding basal cell carcinoma of the skin after radical treatment, squamous epithelial carcinoma of the skin, and/or carcinoma in situ after radical resection)；
* Currently participating in an interventional clinical study or has received another investigational drug or has used investigational devices in the 4 weeks prior to initial dosing；
* Evidence of medical history or disease that may interfere with trial results, prevent participants from participating fully in the study, abnormal treatment or laboratory test values, or other conditions that the investigator deems unsuitable for enrollment；

Primary outcomes:
measure: Adverse events
timeFrame: 6 months
Secondary outcomes:
measure: Major Pathological Response
timeFrame: 6 months
measure: Complete Pathological Response
timeFrame: 6 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT03319693: Molecular Characterization of Primary Mucosal Melanoma
Official title: Molecular Characterization of Primary Mucosal Melanoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mucosal Melanoma
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2017-10-24
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with MPM

Brief summary: Primary mucosal melanomas (MPM) are rarer than cutaneous melanomas, but also more severe. They are usually refractory to conventional approaches, regularly excluded from major therapeutic programs and not sensitive to new targeted therapies orphans. " The identification of therapeutic targets and accessibility to existing, developing or future targeted therapies improves the survival of patients with MPM.

The principal goal is to describe, using a large panel of genes, the prevalence of major mutations in a cohort of MPMs based on the population of a French region.


Eligibility criteria: Inclusion criteria:

* Incident Mucosal melanoma in the Champagne-Ardenne region 2004-2014

Exclusion criteria:

* Cutaneous melanoma
* Uveal melanoma

Primary outcomes:
measure: The frequency of main mutations identified using the NGS panel
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Chu Reims
Study officials:
References:
Clinical trial NCT02644993: Registry for Analysis of Quality of Life, Normal Organ Toxicity and Survival of Pediatric Patients Treated With Proton Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pediatric Cancer Patients
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-01-01
Enrollment: 400
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study aim of this study is to evaluate the effect of proton therapy on quality of life and long-term normal tissue toxicities of the pediatric cancer patients. Based on these results, the predictive model of long-term normal tissue toxicities, survival, and quality of life could be recognized. Risk-adapted treatment strategy based on the predictive model in pediatric cancer patients could be established.


Eligibility criteria: Inclusion Criteria:

* less than 18 years of age
* patient who is planned to receive proton therapy at Samsung Medical Center
* Informed consent

Exclusion Criteria:

* Refuse to participate this cohort study

Primary outcomes:
measure: Quality of Life Questionnaire
timeFrame: within 2 weeks before proton beam therapy
Secondary outcomes:
measure: Quality of Life Questionnaire baseline
timeFrame: within 1 week before proton beam therapy completion
measure: Quality of Life Questionnaire
timeFrame: 3-6 months after proton beam therapy
measure: Quality of Life Questionnaire
timeFrame: 1 year after proton beam therapy
measure: Quality of Life Questionnaire
timeFrame: 3 years after proton beam therapy
measure: Quality of Life Questionnaire
timeFrame: 5 years after proton beam therapy
measure: Quality of Life Questionnaire
timeFrame: 10 years after proton beam therapy
measure: Adverse event
timeFrame: 3-6 months after proton beam therapy
measure: Adverse event
timeFrame: 1 year after proton beam therapy
measure: Adverse event
timeFrame: 3 years after proton beam therapy
measure: Adverse event
timeFrame: 5 years after proton beam therapy
measure: Adverse event
timeFrame: 10 years after proton beam therapy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Proton therapy center, Samsung Medical Center
name: Do Hoon Lim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04481893: Interest of the Virtual Reality Headset in the Management of Perioperative Stress in Patients Candidates for Total Thyroidectomy
Official title: Interest of the Virtual Reality Headset in the Management of Perioperative Stress in Patients Candidates for Total Thyroidectomy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Thyroid Cancer
Thyroidectomy
Keywords: virtual reality headset
stress
hypnose
Lead sponsor: Centre Francois Baclesse
Sponsor class: OTHER
First posted: 2020-07-22
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Study the interest of hypnosis techniques by virtual reality based on the use of a virtual reality headset with the AQUA® application on the reduction of pre-operative stress in patients candidates for total thyroidectomy


Eligibility criteria: Inclusion Criteria:

* Patient\> 18 years old
* Man or woman
* Patient candidate for a total thyroidectomy, or a thyroid totalization
* Preoperative Euthyroidism
* Can justify outpatient care: score of the American Society of Anesthesiology (ASA) 1, 2 or 3 stable; accompanied for return at home; can be watched by a loved one the night after returning home; reachable by telephone; living within an hour of transportation from a hospital and having a good level of understanding.
* No history of parathyroid or recurrent pathology
* Signature of informed consent before any specific procedure related to the study
* Subject affiliated with a health security system

Exclusion Criteria:

* Patient with a submerged goiter (lower edge of the thyroid not seen on the preoperative cervical ultrasound)
* Patient with uncontrolled infectious pathology
* Pregnant or breastfeeding woman or lack of contraception during genital activity
* Patient with illnesses or conditions that hinder their ability to understand follow and / or comply with study procedures
* Patient with personality disorders and / or psychiatric pathology
* Patient deprived of liberty or placed under the authority of a guardian

Primary outcomes:
measure: Change of Anxiety state (STAI-Y scale)
timeFrame: Before surgery and up to 2 hours after surgery
measure: Change of Anxiety state(AE scale)
timeFrame: Before surgery and up to 2 hours after surgery
Secondary outcomes:
measure: Anxiety evaluation by Amsterdam Preoperative Anxiety and Information Scale (APAIS)
timeFrame: up to 1 month after surgery
measure: Pain evaluation (Visual Analog Pain Scale)
timeFrame: up to 1 month after surgery
measure: Satisfaction of patients by EVAN-G scale (Evaluation of the General Anesthesia feelings)
timeFrame: Up to 2 hours after surgery
measure: Taking of anxiolytics
timeFrame: up to 1 month after surgery
Other outcomes:
Locations:
city: Caen
country: France
facility: Centre François Baclesse
city: Caen
country: France
facility: CHU CAEN
city: Rouen
country: France
facility: Clinique Mathilde
Study officials:
References:
Clinical trial NCT04649593: The Study of Giving Birth, a Study About Treatment of Labor Dystocia
Official title: The Giving Birth Project, a Study of Labor Dystocia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dystocia
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 2000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: According to the clinic's memo, when the labor is found to be dystocic, the woman is asked about her participation in the study. If the woman admits participation, she is included in the project. This is also noted in her journal.
Primary purpose: TREATMENT

Brief summary: Labor dystocia is an intransigent, high-profile issue in obstetric care, which causes significant maternal morbidity in low resource settings and maternal dissatisfaction, and increased healthcare costs worldwide. Amniotic fluid lactate, (AFL), values have recently been shown to reflect the metabolic status of the uterus and high levels have a strong association with subsequent need for operative intervention due to dystocia. In sports medicine, it is known that lactic acid can affect muscular performance but be decreased by bicarbonate given orally before physical activity. Main Outcome Measures: If an intake of bicarbonate, one hour before stimulation with oxytocin in cases with a high AFL value, changes the AFL levels and enhances delivery outcome in dystocic deliveries.

Design: Randomized controlled trial

Detailed description: Primary question: whether high AFL values (\>12mmol/l) in women with observed dystocic labor are best treated by

1. to handle childbirth according to the clinic's current guidelines in case of labor dystocia, i.e. with oxytocin stimulation
2. an intake of bicarbonate (Samarin) dissolved in water given 1 hour before the oxytocin is started Primary outcome variable A comparison of the frequency of spontaneous vaginal delivery in the observed two described intervention groups.

Eligibility criteria: Inclusion Criteria:

* dystocic labor with a need of oxytocin \>=34w of gestation

Exclusion Criteria:

* Nondystocic labors.
* Women who don't understand Swedish or English
* Premature deliveries (\<34w)

Primary outcomes:
measure: Labor outcome
timeFrame: through study completion, an average of 1 year
measure: AFL values
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: The use of oxytocin
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Eva Wiberg-Itzel
Study officials:
References:
Clinical trial NCT06245993: Study of Residuals Deformities After Diaphyseal Femoral Fracture in Children Treated by Skin Traction
Official title: Study of Residuals Deformities After Diaphyseal Femoral Fracture in Children Treated by Skin Traction
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: EOS
Keywords: EOS
skin traction
femoral fracture
remodeling
leg length
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2024-02-07
Enrollment: 53
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diaphyseal femoral fracture in children \<6 years old are treated by the skin traction.

The children have a Clinical examination and EOS imaging 3 years after skin traction treatment for femoral shaft fracture.

Brief summary: Diaphyseal femoral fracture in children \<6 years old are treated by the skin traction technique. As demonstrated by numerous studies, given the significant potential for bone remodeling in young children, remodeling (excluding rotational disorder) allows anatomical correction. The aim of this study is to confirm, via EOS imaging, the absence of residual deformities 3 years after the end of treatment in children treated in Amiens hospital department.


Eligibility criteria: Inclusion Criteria:

* \<6 years old at the time of the fracture
* treatment by skin zenith traction
* femoral shaft fracture, traumatic, unilateral

Exclusion Criteria:

* Multiple fracture
* pathological fracture
* history of lower limb fracture
* contraindication to zenith traction

Primary outcomes:
measure: absence of lower limb overgrowth
timeFrame: 3 years
Secondary outcomes:
measure: Measurement of the angle on the lower limb sagittal axis
timeFrame: 3 years
measure: Measurement of the angle on the lower limb on the frontal axis
timeFrame: 3 years
measure: Measurement of the angle on the lower limb on the frontal axis
timeFrame: 3 years
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT01285193: Treating Hypertension With Breath Control
Official title: A Randomized Controlled Trial to Treat Hypertension by Regularising and Slowing Breathing
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypertension
Keywords: hypertension
high blood pressure
treatment
breath control
breathing exercise
audio CD
Lead sponsor: Penang Hospital, Malaysia
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health, Malaysia
First posted: 2011-01-27
Enrollment: 84
Sex: ALL
Minimum age (years): 19
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 determine if blood pressure can be reduced in hypertensive subjects by regularising and slowing their breathing. This may be a safe and affordable complementary treatment for hypertension.

Detailed description: This is a randomised controlled trial in which hypertensive subjects allocated to receive either a CD with relaxation music or one with the same music plus certain sound cues to guide the listener on when to breathe. The subjects will continue with their normal medications and the intervention will last 2 months.

Eligibility criteria: Inclusion Criteria:

* Above 18 years old
* Patients with essential hypertension
* Systolic BP from 140 to 159 mm Hg
* Diastolic BP from 90 to 99 mm Hg
* On hypertensive medication for at least 3 months before the study
* Hypertensive medication unchanged during the 3 months before the study
* Patients able to fill in a log sheet

Exclusion Criteria:

* ischaemic heart disease
* congestive heart failure
* cardiac arrhythmias
* renal failure
* diabetes mellitus
* previous stroke
* major organ failure
* cigarette smoking
* respiratory diseases
* psychiatric disorders
* severe obesity (BMI \>35 kg/m2)
* hearing impairment
* unable to operate a CD player or do not have access to a CD player
* arm circumference \<22 cm. or \>42 cm.

Primary outcomes:
measure: Diastolic blood pressure
timeFrame: 2 months
Secondary outcomes:
measure: Systolic blood presure
timeFrame: 2 months
Other outcomes:
Locations:
city: Georgetown
country: Malaysia
facility: Ng Kum Keong
state: Penang
Study officials:
affiliation: Clinical Research Centre, Penang Hospital
name: Kum Keong Ng, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grossman E, Grossman A, Schein MH, Zimlichman R, Gavish B. Breathing-control lowers blood pressure. J Hum Hypertens. 2001 Apr;15(4):263-9. doi: 10.1038/sj.jhh.1001147.
citation: Kow FP, Adlina B, Sivasangari S, Punithavathi N, Ng KK, Ang AH, Ong LM. The impact of music guided deep breathing exercise on blood pressure control - A participant blinded randomised controlled study. Med J Malaysia. 2018 Aug;73(4):233-238.
Clinical trial NCT00262093: Angiogenesis Markers in Primiparas Versus Multiparas: Relevance to Preeclampsia Incidence
Official title: Angiogenesis Markers in Primiparas Versus Multiparas: Relevance to Preeclampsia Incidence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pre-Eclampsia
Keywords: preeclampsia
sFlt1
PlGF
parity
angiogenesis
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Beth Israel Deaconess Medical Center
First posted: 2005-12-06
Enrollment: 200
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: The reason for having a higher incidence of preeclampsia in primiparas may involve angiogenesis imbalance in these patients.

Detailed description: Primiparity is one of the main risk factors for having preeclampsia during pregnancy. Recently, sFlt-1, soluble FMS-like tyrosine kinase-1, has been shown to be a major molecule involved in the pathogenesis of preeclampsia. Higher sFlt-1 mRNA, higher serum levels of sFlt-1 as well as lower PlGF, placental growth factor, have been found in preeclamptic patients.

We intend to check the angiogenesis profile of primiparas as compared to multiparas.

Eligibility criteria: Inclusion Criteria:

* Every delivery

Exclusion Criteria:

* Preeclampsia or pregnancy induced hypertension

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah-Hebrew University Medical School
name: Yuval Bdolah, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01097993: A Single-centre, Randomised, Double-blind, Controlled, Parallel-group Study to Evaluate the Effect of a Fermented Dairy Product on Abdominal Distension, Digestive Symptoms and Rectal Sensitivity in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Women With IBS-C
Lead sponsor: Danone Global Research & Innovation Center
Sponsor class: INDUSTRY
First posted: 2010-04-02
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of a commercially available fermented dairy product containing probiotics (4 weeks, twice a day) on abdominal distension in IBS patients with constipation (IBS-C).


Eligibility criteria: Inclusion Criteria:

* female
* Age: 18-70

Exclusion Criteria:

* NA

Primary outcomes:
measure: Mean abdominal distension after a 4-week period of product consumption in IBS-C patients
timeFrame: 0-4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester Hospital
Study officials:
References: