louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06958471: The Effect of Individualized Developmental Care Education
Official title: The Effect of Individualized Developmental Care Education Given to Mothers of Premature Infants on Maternal Self-Efficacy and Attachment Levels
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Premature
Self Efficacy
Attachment
Maternal
Keywords: Premature
Individualized Developmental Care
Attachment
Self Efficacy
Maternal
Lead sponsor: University of Yalova
Sponsor class: OTHER
First posted: 2025-05-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled and Quasi-experimental research
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to evaluate the effect of individualized developmental care education provided to mothers of premature infants on maternal self-efficacy and maternal-infant attachment. Premature birth can be a stressful and anxiety-inducing experience for mothers, which may negatively impact their self-confidence and ability to establish an emotional bond with their baby.

Structured and individualized developmental care education provided in the neonatal intensive care unit (NICU) enhances mothers' knowledge and promotes their active participation in the care process, thereby strengthening their maternal roles. Increased self-efficacy helps mothers to take a more active and conscious role in their infant's care, while stronger maternal attachment plays a critical role in the infant's emotional and neurodevelopmental health.

Therefore, the integration and dissemination of such supportive educational interventions within the healthcare system are essential steps that can positively influence both maternal and infant health outcomes.


Eligibility criteria: Inclusion Criteria:

* The mother must have a premature baby born between 22 and 32 weeks gestation, admitted to a level 3 NICU.
* The baby's stay in the level 3 NICU must be at least one month.
* The mother must not have any diagnosed psychiatric disorders.
* The baby must not have severe congenital anomalies incompatible with life.
* The mother must be literate and open to communication.
* The mother must be willing and volunteer to participate in the research.

Exclusion Criteria:

* The baby's stay in the NICU must be at least one month.

Primary outcomes:
measure: Self-Efficacy
timeFrame: The first three days of hospitalization and one month after hospitalization
measure: Maternal Attachment Levels
timeFrame: The first three days of hospitalization and one month after hospitalization
Secondary outcomes:
Other outcomes:
Locations:
city: Yalova
country: Turkey
facility: Emel Avçin
Study officials:
affiliation: Yalova Unıversıty
name: EMEL AVÇİN, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01833871: The Use of Doppler to Diagnose Myometrial Masses
Official title: Uterine Artery Doppler and Three Dimensional Power Doppler in the Diagnosis of Myometrial Masses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Uterine Masses
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2013-04-17
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Colour Doppler sonography has also been evaluated in differentiating adenomyosis from fibroids. Two dimensional color Doppler ultrasound revealed that 87% of adenomyosis cases had vessel distributions different from those found in leiomyoma cases, in addition to a high pulsatility index (PI) .Adenomyotic lesions had randomly scattered vessels or intratumoral signals while leiomyomas usually had peripheral scattered or outer feeding vessels.

Detailed description: Because it is more sensitive, less angle-dependent, and not susceptible to aliasing , power Doppler Sonography has the potential to detect fluctuations in blood flow , with results superior to those of frequency-based color Doppler sonography, particularly in situations of low-velocity blood flow. Three dimensional power Doppler ultrasonography can be applied to differentiate between uterine adenomyosis and leiomyoma ,and it may reduce the number of false positives by detailed investigations.

Eligibility criteria: Inclusion Criteria:

* Age between 20 \& 60 years.
* Asymptomatic pts which discover the mass accidentally .
* Patients with symptoms like menorrhagia, menometrorrhagia, dysmenorrheal , abdominal masses.
* Patients scheduled for hysterectomy(abdominal/vaginal or Laparoscopic)
* Patients scheduled for myomectomy.

Exclusion Criteria:

* Pregnant patients
* Age over 60 or under 20years.
* Conservative management (Non surgical)

Primary outcomes:
measure: Power Doppler Vascular indices
timeFrame: 9 months
measure: Uterine artery doppler indices in fibroids in relation to adenomyosis
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT00841893: Effects of a Specific Spice on Energy Metabolism
Official title: Effects of a Specific Spice on Energy Expenditure, Substrate Oxidation, Appetite and Energy Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Thermogenesis
Meal-induced thermogenesis
Energy expenditure
Fat oxidation
Carbohydrate oxidation
Bioactive ingredient
Spice
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2009-02-11
Enrollment: 16
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The objective of this study is to examine whether a specific spice is capable of affecting energy metabolism.

Since chili and other spices have been shown to increase energy expenditure and in some cases also affect energy intake/appetite compared to placebo, the investigators expect that the specific spice may actually increase energy expenditure and potentially also decrease appetite - although not to a large degree.

Detailed description: Several pungent food ingredients, such as chili, and also other bioactive food ingredients, e.g. green tea, have been shown to be able to increase energy expenditure and fat oxidation during the hours following a meal containing the bioactive ingredient. Furthermore, we will also look at the subjects own feelings of appetite and thereby examine whether the appetite is affected by the spicy food, since a few studies have suggested an effect of bioactive ingredients on appetite/energy intake. We expect to see some small effects on these parameters.

Eligibility criteria: Inclusion Criteria:

* male
* healthy and not using medication (regularly)
* normal weight
* non-smoker
* tolerate and like spicy food
* stable body weight last two months

Exclusion Criteria:

* increased blood pressure
* mental, metabolic and chronic diseases

Primary outcomes:
measure: Energy expenditure (resting)/Meal-induced thermogenesis
timeFrame: November 2008
Secondary outcomes:
measure: VAS-scores for different appetite parameters (incl. satiety, hunger, fullness, prospective food intake, well-being, thirst etc.)
timeFrame: November 2008
measure: Blood pressure
timeFrame: November 2008
measure: Heart rate
timeFrame: November 2008
measure: Substrate oxidation (fat and carbohydrate)
timeFrame: November 2008
Other outcomes:
Locations:
city: Frederiksberg C
country: Denmark
facility: Department of Human Nutrition, Faculty of Life Sciences, university of Copenhagen
state: Copenhagen
Study officials:
affiliation: Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
name: Arne Astrup, Professor MD
role: STUDY_CHAIR
References:
Clinical trial NCT06230393: An Extension Trial for Patients With Open-Angle Glaucoma Who Participated in the DF6-CL-20-01 Protocol.
Official title: An Extension Trial to Evaluate the Long Term Safety and Effectiveness of the STREAMLINE® SURGICAL SYSTEM in Patients With Open-Angle Glaucoma Who Participated in the DF6-CL-20-01 Protocol.
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Open Angle Glaucoma
Intraocular Pressure
Keywords: Intraocular Pressure
Glaucoma
MIGS
Lead sponsor: New World Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2024-01-30
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who participated in the DF6-CL-20-01 trial

Brief summary: The purpose of this study is to evaluate long term safety and effectiveness of the STREAMLINE® SURGICAL SYSTEM

Detailed description: A Retrospective, nonrandomized, open-label study to evaluate the long term safety and IOP-lowering effectiveness of STREAMLINE® SURGICAL SYSTEM in patients with open-angle glaucoma who participated in the DF6-CL-20-01 protocol.

Eligibility criteria: Inclusion Criteria:

participated in the DF6-CL-20-01 trial.

Exclusion Criteria:

lost to follow up in the DF6-CL-20-01 trial

Primary outcomes:
measure: Change in IOP
timeFrame: 24months; 36 months; 48months, 60 months
Secondary outcomes:
measure: Number of IOP lowering medications
timeFrame: 24months; 36 months; 48months, 60 months
Other outcomes:
Locations:
city: San José
country: Costa Rica
facility: Clinica 20/20
Study officials:
References:
Clinical trial NCT00798993: Effect of 25-hydroxyvitamin D and a Structured Exercise Program on Dialysis Patients
Official title: The Effect of 25-hydroxyvitamin D Supplementation and a Structured Exercise Program on Exercise Capacity and Quality of Life in Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: End Stage Kidney Disease
Keywords: Chronic kidney failure
25 hydroxyvitamin D
falls
exercise
quadriceps strength
Lead sponsor: Sir Charles Gairdner Hospital
Sponsor class: OTHER
First posted: 2008-11-27
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to examine the effect of 25 hydroxyvitamin D supplementation and a structured exercise program on the exercise capacity and quality of life of haemodialysis patients with 25 hydroxyvitamin D insufficiency.


Eligibility criteria: Inclusion Criteria:

1. Stable on dialysis for at least 3 months
2. Able to obtain informed consent
3. Medically stable
4. Dialysis adequacy at target for small solute clearance (ie Kt/V\>1.2 or Urea reduction ratio\>65%)
5. Serum 25-hydroxyvitamin D levels less than 75nmol/L at baseline

Exclusion Criteria:

1. Limb Amputation
2. Impaired cognition
3. Impaired vision
4. Haemoglobin concentration \< 110g/L
5. Change in Erythropoiesis stimulating agent dose over the last 2 months
6. Unable or unwilling to comply with exercise program

Primary outcomes:
measure: Exercise capacity - modified shuttle walk test
timeFrame: Basesline, 3 & 6 months
Secondary outcomes:
measure: Quality of life with KDQOL
timeFrame: Baseline, 3 & 6 months
measure: Quadriceps Strength
timeFrame: Baseline, 3 & 6 months
measure: Serum phosphate
timeFrame: baselibe, 3 & 6 months
measure: Feeling thermometer
timeFrame: Baseline, 3 & 6 months
measure: Timed up and go
timeFrame: baseline, 3 & 6 months
measure: Falls
timeFrame: continuous
measure: Pulse wave velocity
timeFrame: baseline, 3 & 6 months
measure: Bioimpedance
timeFrame: Baseline, 3 & 6 months
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Sir Charles Gairdner Hospital
state: Western Australia
Study officials:
affiliation: Sir Charles Gairdner Hospital
name: Ben Bull
role: PRINCIPAL_INVESTIGATOR
affiliation: Sir Charles Gairdner Hospital
name: Neil Boudville
role: STUDY_DIRECTOR
References:
Clinical trial NCT00206193: Termination of Pregnancy With Mifepristone and Misoprostol Versus Sulprostone
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Abortion, Induced
Keywords: termination of pregnancy
Lead sponsor: Atrium Medical Center
Sponsor class: OTHER
First posted: 2005-09-21
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to determine which medical treatment is the most effective to terminate a pregnancy.


Eligibility criteria: Inclusion Criteria:

* Pregnant women by whom a termination of pregnancy is desired.

Exclusion Criteria:

* Women with liver/kidney disease
* Women on long-term use of corticosteroids (\> 6 months)
* Cardiovascular problems
* Therapy-resistant diabetic women
* Therapy-resistant asthma/bronchitis
* Thalassemia
* Ulcerative colitis
* Peptic ulcer disease
* Glaucoma
* Porphyria
* Allergic reaction to prostaglandin or mifepristone
* Women with a prior caesarian section or women with contractions at the start of the study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Atrium Medisch Centrum
state: Limburg
Study officials:
affiliation: Atrium Medisch Centrum, Heerlen
name: F Roumen, Dr.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01519193: Treatment of Aggressive Behavior and Post-Traumatic Stress Disorder
Official title: Treatment of Aggressive Behavior and Post-Traumatic Stress Disorder in Former Street Children and Vulnerable Children in Burundi With Narrative Exposure Therapy for Violent Offenders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Aggressive Behavior
Post-Traumatic Stress Disorder
Keywords: Aggressive Behavior
Appetitive Aggression
Post-Traumatic Stress Disorder
Lead sponsor: University of Konstanz
Sponsor class: OTHER
First posted: 2012-01-26
Enrollment: 42
Sex: MALE
Minimum age (years): 12
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Street children and children of vulnerable families in conflict or former conflict regions are often exposed to multiple traumatic events and situations in which they are forced to engage in violent behavior. The Narrative Exposure Therapy for violent offenders (NETvo) aims to reduce both PTSD symptoms and aggressive behavior. It helps the children to anchor fearful experiences and positive emotions linked to violent behaviour in the past. Additionally, visions for the future are developed in order to foster successful reintegration into society.


Eligibility criteria: Inclusion Criteria:

* Positive Emotions concerning aggressive behavior derived from expert interviews with higher Scores of the Appetitive Aggression Scale (AAS)
* children are part of an aid program for reintegration into society

Exclusion Criteria:

* current substance dependance or use of antipsychotic drugs
* chronically ill children

Primary outcomes:
measure: Positive emotions linked to aggressive behavior via the AAS-CS (Appetitive Aggressions Scale for children and students)
timeFrame: 6 months
measure: Load of traumatic symptoms measured via the UCLA Adolescent PTSD Index (Clinician-administered PTSD scale)
timeFrame: 6 months
Secondary outcomes:
measure: Load of depressive symptoms measured via the MINI-KID
timeFrame: 6 months
measure: Strength of suicidal ideation measured via the MINI-KID
timeFrame: 6 months
measure: Functionality measured via the CGAS (Children's Global Assessment Scale) and SDQ (Strengths and Difficulties Questionnaire)
timeFrame: 6 months
Other outcomes:
Locations:
city: Bujumbura
country: Burundi
facility: Fondation Stamm
Study officials:
affiliation: University of Constance
name: Anselm Crombach, Dipl.-Psych.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00148993: Allogeneic Tumor Cell Vaccination in Patients With Solid Tumors
Official title: Allogeneic Tumor Cell Vaccination in Patients With Solid Tumors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Metastatic Solid Tumors
Keywords: Tumor cell vaccine
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: The International Center for Cell Therapy & Cancer Immunotherapy (CTCI)
First posted: 2005-09-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The goal of this study is to apply allogeneic tumor cell vaccination for immunotherapy in patients with micro-metastatic disease and/or in patients at high risk disease progression. The present study will use allogeneic tumor cell lines for tumor cell vaccines that share MHC determinants with the patient aiming to overcome possible restriction of antigen presentation.


Eligibility criteria: Inclusion Criteria:

* Patients with measurable metastatic disease or disease resistant to chemotherapy or with minimal residual disease at high risk to relapse.

Exclusion Criteria:

* Karnofsky less than 60%. Unrelated condition requiring the use of any cytotoxic agents or immunosuppressive agents which may interfere with optimal immune response.

Primary outcomes:
measure: Investigate the feasibility of anti-tumor immune response by allogeneic tumor cell vaccine using tumor cells that share MHC determinants with the patient.
Secondary outcomes:
measure: Investigate the feasibility of immune responses against cancer cells by combining allogeneic TCV with indomethacin, cimetidine, tetanus and rIL-2.
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: The International Center for Cell Therapy & Cancer Immunotherapy (CTCI)
Study officials:
affiliation: The International Center for Cell Therapy & Cancer Immunotherapy (CTCI)
name: shimon slavin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04029493: The Situation of Re-infection of Helicobacter Pylori After Successful Eradication
Official title: The Situation of Re-infection of Helicobacter Pylori After Successful Eradication
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Helicobacter Pylori
Keywords: Re-infection
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2019-07-23
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients in Shandong province, aged between 18 and 70 years old, with previous positive H. pylori infection that suceessed to be eradicated by therapies are included.

Brief summary: The patients who accept the quadruple eradication program of the helicobacter pylori and success to eradicate helicobacter pylori will be followed-up to observe the situation of re-infection of helicobacter pylori.

Detailed description: The patients with helicobacter pylori accepted he quadruple eradication program of the helicobacter pylori.They will be followed-up from 1 year to 5 years to observe the situation of re-infection of helicobacter pylori.The rate of the re-infection will be described by frequency and percentage.

Eligibility criteria: Inclusion Criteria:

* Patients, aged between 18 and 70 years old, with positive H. pylori infection that was not eradicated by previous therapies are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.

Exclusion Criteria:

* Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.

Primary outcomes:
measure: The rate of re-infection
timeFrame: 4 years
Secondary outcomes:
measure: The influence factors of the rate of re-infection
timeFrame: 4 years
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo, MD,PhD
role: STUDY_CHAIR
affiliation: Qilu Hospital of Shandong University
name: Tian Ma, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03044093: Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion
Official title: Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Second Trimester Abortion
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2017-02-06
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Mifepristone and Misoprostol Compared With Misoprostol Alone for Second Trimester Abortion - a Double Blinded Randomized Controlled Trial


Eligibility criteria: Inclusion Criteria:

* healthy
* no allergy known to these drugs
* second trimester abortion

Exclusion Criteria:

* hematology diseases
* clotting factor deficiency

Primary outcomes:
measure: Reduction in Hospital Stay Duration
timeFrame: Up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Campus
Study officials:
References: