louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06291389: Intraoperative Peak Airway Pressure Changes on Postoperative Pulmonary Function After Muscle Plication
Official title: Effects of Intraoperative Peak Airway Pressure Changes on Postoperative Pulmonary Function After Muscle Plication in Abdominoplasty Operations: A Randomized Double-Blind Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Abdominal Compartment Syndrome
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
Collaborators: name: Benha University
First posted: 2024-03-04
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: age ranged between 20 and 50 years old,- American Society of Anesthesiologists (ASA) physical status classification I and came for abdominoplasty operation

Brief summary: An abdominal panniculus excision procedure is known as an abdominoplasty (panniculectomy). Musculofascial plication is a crucial aspect of abdominoplasty, especially for patients with significant divarication of the recti muscles. This study aimed to evaluate the effect of intraoperative changes in peak airway pressure (PAP) after muscle plication on postoperative pulmonary function.

Detailed description: Musculofascial plication is a crucial aspect of abdominoplasty, especially for patients with significant divarication of the recti muscles. This surgical procedure involves the removal of surplus skin and fat around the abdomen, known as panneculectomy, and the anterior abdominal wall muscles' laxity being tightened. This study aimed to elucidate the effect of intraoperative changes in PAP after muscle plication on postoperative pulmonary function.

Eligibility criteria: Inclusion Criteria:

* age ranged between 20 and 50 years old,
* American Society of Anesthesiologists (ASA) physical status classification I
* came for abdominoplasty operation

Exclusion Criteria:

* anemia or hemoglobin levels below 11g/dl
* bleeding problems
* cardiovascular disorders
* restrictive and obstructive respiratory disease
* abdominoplasty without plication.

Primary outcomes:
measure: Intraoperative peak airway pressure (PAP)
timeFrame: 4 hours
Secondary outcomes:
measure: Duration of oxygen therapy
timeFrame: 1 week
measure: Post operative Tidal Volume (Vt) (Measured by spirometer)
timeFrame: 24 hours postoperatively
measure: Post operative Respiratory Rate (RR)
timeFrame: 24 hours postoperatively
measure: Hospital stay.
timeFrame: 1 week
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Neveen Kohaf
Study officials:
affiliation: Al-Azhar University
name: Neveen Kohaf, ph.d
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00901589: Marine n-3 Polyunsaturated Fatty Acids in Pre- and Postmenopausal Women
Official title: The Incorporation of Marine n-3 Polyunsaturated Fatty Acids in Pre- and Postmenopausal Women: a Randomized Double-Blinded Placebo-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postmenopause
Premenopause
Keywords: n-3 PUFAs
menopause
adipose tissue
estrogens
Incorporation of fishoil in pre- and postmenopausal women
Marine n-3 PUFAs influence on female hormones in blood
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
First posted: 2009-05-14
Enrollment: 92
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: BASIC_SCIENCE

Brief summary: The study is a randomised placebo controlled double-blinded clinical trial where a group of healthy pre- and postmenopausal women is randomised to the intake of fish oil capsules or placebo oil capsules for 12 weeks. Anthropometric measurements(weight, height,blood pressure) blood samples and adipose tissue biopsies will be taken in order to illustrate the effect of marine n-3 PUFAs (fish oil) on the concentration of circulating female hormones and to investigate what impact menopause might have on the ability to incorporate marine n-3 PUFAs into tissues.


Eligibility criteria: Inclusion Criteria:

* age 18-70 years old
* healthy or well-treated chronic disease

Exclusion Criteria:

* hormone treatment
* foreseen compliance problem
* fish oil consumers

Primary outcomes:
measure: Content of marine n-PUFAs as percent of total content of fatty acids in adipose tissue and in platelets before and after intervention
Secondary outcomes:
measure: Measurement of oestrogen concentrations in blood before and after intervention
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Center for cardiovascular research, Aalborg Hospital
Study officials:
References:
Clinical trial NCT03420989: Elaboration of New Generation Snacks
Official title: Development of a Novel Healthy Snacks Including Seaweeds and Carob Which Improve Risk Factors Associated With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Snack Food
Keywords: carob
seaweed
snack food
obese subjects
Lead sponsor: Endocrinology and Clinical Nutrition Research Center, Spain
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: It is a blind randomized clinical trial of nutritional intervention in humans with a snack (seaweeds and carob), compared to a control snack without the bioactive ingredients studied but of similar nutritional composition, to evaluate the effect on the lipid profile, glycemia and Insulin resistance.

Detailed description: The design will consist of a double-blind randomized study in adult subjects with metabolic syndrome, who will consume snack (enriched in seaweeds and carob) (50 g / day) vs. conventional snack for 8 weeks.

All the next parameters will be measured/calculated at basal time and after 8 weeks of intervention. The next biochemical parameters will be measured: Total cholesterol, LDL cholesterol, HDL, triglycerides will be analyzed using an enzyme-colorimetric method (Roche Diagnostics , Mannheim, Germany). Glucose will be determined by the method of glucose oxidase (Glucose analyzer 2, Beckman Instruments, Fullerton, California), insulin will be determined by Elisa (ELISA Diagnostic Corporation, Los Angeles, CA) and HOMA will be calculated by the formula Matthew et al. , 1985 (HOMA = (glucose \* insulin) / 22.5). Body weight and fat mass by bioimpedance will be measured, too. Blood pressure (Systolic and diastolic blood pressure) will be measured, too. A diet records for 3 days and a satiety scale will be performed at the beginning and end of the intervention period.

Eligibility criteria: Inclusion Criteria:

* presence of metabolic syndrome by (Adult Treatment Panel III) criteria

Exclusion Criteria:

* consume supplements (vitamins, minerals or other dietary components),
* non-restrictive diet
* known chronic disease (eg diabetes, cardiovascular disease, Inflammatory diseases).
* active cancer

Primary outcomes:
measure: Lipoproteins
timeFrame: change from baseline HDL cholesterol (mg/dl) and LDL cholesterol (mg/dl )levels at 8 weeks
Secondary outcomes:
measure: carbohydrate metabolism
timeFrame: change from baseline fasting glucose levels (mg/dl) at 8 weeks
measure: carbohydrate metabolism
timeFrame: change from baseline insulin levels (UI/L) at 8 weeks
measure: carbohydrate metabolism
timeFrame: change from baseline HOMA-Insulin Resistance (units) at 8 weeks
measure: Blood pressure
timeFrame: change from baseline systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) at 8 weeks
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Daniel de Luis Roman
Study officials:
References:
Clinical trial NCT06862089: A Prospective Study Evaluating the Impact of Conservative Management on Retained Products of Conception and EMV
Official title: A Prospective Study Evaluating the Impact of Conservative Management on Retained Products of Conception and EMV
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Retained Products of Conception
Miscarriage
Conservative Management
Lead sponsor: Fu Xing Hospital, Capital Medical University
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 120
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population of who visited the outpatient department of the hysteroscopy center of our hospital from October 2024 to October 2026 and were provisionally diagnosed as " retained products of conception (RPOC)" based on their history and symptoms.

Brief summary: The goal of this observational study is to learn about the therapeutic effects of the conservative treatment approach on pepole with retained products of conception (RPOC) and Enhanced myometrial vascularity (EMV).

The main question it aims to answer is: Is it possible to achieve the natural resolution of RPOC by combining it with EMV through conservative treatment？ Participants will receive conservative treatment (such as mifepristone, GnRH-a, or expectant management) following the initial diagnosis of RPOC and EMV, and the therapeutic efficacy of the conservative approach will be assessed after the completion of two menstrual cycles.


Eligibility criteria: Inclusion Criteria:

* Recent history of miscarriage or delivery (within the past 8 weeks)
* Strong willingness to undergo conservative management
* Hemodynamically stable
* Signed informed consent form

Exclusion Criteria:

* Heavy vaginal bleeding (requiring immediate surgical intervention)
* Active pelvic or systemic infection (e.g., fever \>38°C, elevated CRP/WBC)
* Severe dysfunction of vital organs (heart, liver, or kidney)
* Known drug allergies or contraindications to proposed medications (e.g., misoprostol intolerance)
* Suspected ectopic pregnancy or gestational trophoblastic disease (confirmed by ultrasound or β-hCG levels)
* Placenta accreta spectrum disorders diagnosed during current pregnancy
* History of uterine artery embolization

Primary outcomes:
measure: The disappearance rate of RPOC
timeFrame: After conservative treatment, transvaginal ultrasound was performed at the end of the second menstrual cycle (calculated from the first day of menses, 28-30 days per cycle) to assess RPOC resolution
Secondary outcomes:
measure: the disappearance rate of EMV
timeFrame: Immediately after the completion of conservative treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Hysteroscopy Center, Fuxing Hospital, Capital Medical University
Study officials:
References:
Clinical trial NCT04382989: Factors Influencing the Composition of Human Milk
Official title: The Influence of Various Maternal, Infant and Environmental Factors on Human Milk Composition Among Lithuanian Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Milk Collection
Lead sponsor: Vilnius University
Sponsor class: OTHER
Collaborators: name: University of Cagliari
First posted: 2020-05-11
Enrollment: 174
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Mothers of newborns admitted at Neonatal Center of Vilnius University Hospital Santaros Klinikos, Lithuania

Brief summary: This study aims for characterization of different maternal, infant and environmental factors (e.g. maternal age, pregnancy duration, lactation period, baby gender, circadian rhythm, Holder pasteurisation, etc.) that influence human milk composition.

Detailed description: The study consists of three parts. In the first part the investigators aim to evaluate human milk macronutrient composition depending on the time after delivery and pregnancy duration.

In the second part the investigators aim to evaluate the circadian variation of human milk macronutrient and energy content depending on pregnancy duration.

In the third part the investigators aim to evaluate the influence of Holder pasteurisation on human milk macronutrient, metabolome and bioactive protein (lysozyme and lactoferrin) content.

Eligibility criteria: Inclusion Criteria:

having obtained informed consent; after a single-birth pregnancy; women who were not on a special diet; lactating mothers who could not breastfeed their newborns due to the baby's medical condition (either prematurity or disease) but who expressed milk.

-

Exclusion Criteria:

breastfeeding mothers; history of maternal diabetes, hepatitis B or C, HIV, tuberculosis, mastitis, or oncological disease; drug addicted.

-

Primary outcomes:
measure: Quantification of total protein concentration in human milk
timeFrame: from the 2nd week, up to 2 months after delivery
Secondary outcomes:
measure: Quantification of total lipids and carbohydrate in human milk
timeFrame: from the 2nd week, up to 2 months after delivery
measure: Quantification of lactoferrin in human milk
timeFrame: 14-16 days after delivery
measure: Quantification of lysozyme in human milk
timeFrame: 14-16 days after delivery
measure: Human milk metabolome analysis
timeFrame: 15-17 days after delivery
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Neonatal centre of Vilnius University Hospital Santaros Klinikos
Study officials:
affiliation: Vilnius University
name: Vytautas Usonis, MD
role: STUDY_DIRECTOR
References:
citation: Paulaviciene IJ, Liubsys A, Eidukaite A, Molyte A, Tamuliene L, Usonis V. The Effect of Prolonged Freezing and Holder Pasteurization on the Macronutrient and Bioactive Protein Compositions of Human Milk. Breastfeed Med. 2020 Sep;15(9):583-588. doi: 10.1089/bfm.2020.0219. Epub 2020 Aug 26.
Clinical trial NCT05480189: Effect of Zoledronic Acid Treatment on Bone-related Events in Breast Cancer Patients With Bone Metastases: a Prospective, Multicenter, Real-world Study
Official title: Effect of Zoledronic Acid Treatment on Bone-related Events in Breast Cancer Patients With Bone Metastases: a Prospective, Multicenter, Real-world Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Histologically Confirmed Breast Cancer ,Diagnosis of Bone Metastasis
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Histologically confirmed breast cancer, Initial diagnosis of bone metastasis

Brief summary: non-intervention、real world study； Effect of timing and regular treatment of zoledronic acid on the incidence of SREs in breast cancer patients

Detailed description: (1) Main Purpose: To observe the clinical efficacy of zoledronic acid regularly in the prevention of SREs in breast cancer patients with bone metastasis (2) Secondary Objectives:

1. To observe whether zoledronic acid prolonged the time of first SREs in patients with bone metastasis;
2. The clinical efficacy and influencing factors of zoledronic acid in different subgroups were observed by subgroup analysis of population baseline, clinical characteristics (such as different types of breast cancer), past history and complications.
3. To observe the clinical distribution, characteristics, timing and compliance of zoledronic acid administration in Chinese breast cancer patients with first bone metastasis.

Eligibility criteria: Inclusion Criteria:

* 1. Age ≥18 years 2. Histologically confirmed breast cancer 3. Initial diagnosis of bone metastasis by MRI or CT and treatment with zoledronic acid 4. Serum creatinine ≤265mol/L or 3.0mg/dl 5. CrCl ≥ 30 ml/min 6. Serum Ca2+ concentration 2.0-3.0 mmonl/L 7.ECOG score ≤2 Voluntary research, informed consent

Exclusion Criteria:

* 1. Pregnant and lactating women 2. Severe liver insufficiency (ALT and/or AST higher than 3 times the upper limit of normal) 3. Patients with osteoarthritis or other bone related diseases need bone targeted therapy 4. Patients with uncontrolled dental problems or planned jaw surgery

Primary outcomes:
measure: SREs
timeFrame: 3 years
Secondary outcomes:
measure: time to first on-study SRE
timeFrame: 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Xiaojia Wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05528289: Effects on PaCO2 Levels of Two Different Nasal Cannula in COPD Patients
Official title: Effects on PaCO2 Levels of Two Different Nasal Cannula in COPD Patients With Persistent Hypercapnia Following an Acute Severe Exacerbation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: HFNC
Hypercapnia
COPD
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2022-09-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: High-flow nasal cannula (HFNC) therapy is increasingly used in the management of acute respiratory failure. Its clinical application has been expanded also in other specific settings In stable COPD patients and in those recovering from acute exacerbation, HFNC can reduce PaCO2, respiratory rate, minute ventilation and respiratory effort.

The aim of this randomized crossover physiological study is to investigate the effects on PaCO2 levels of two different nasal cannula ('Optiflow + Duet' interface vs "standard" nasal interface) in COPD patients with persistent hypercapnia following an acute severe exacerbation


Eligibility criteria: Inclusion Criteria:

* Inpatients recovering from an acute exacerbation of their disease
* Persisting hypercapnia, despite having reached a stabilization in pH (i.e. pH\>7,35 and
* PaCO2\>50 mmHg on 3 consecutive measurements)
* Informed consent

Exclusion Criteria:

* Body Mass Index (BMI) \> 30 kg/m2;
* Previous diagnosis of Obstructive sleep apnea syndrome (OSAS)
* Chest wall disease
* Heart failure
* Severe hemodynamic instability ( need for amine support)
* Acute coronary syndrome (ACS)
* Severe arrhythmia
* Renal insufficiency
* Patients unable to protect respiratory airways
* Respiratory arrest and need for endotracheal intubation
* Pregnancy
* Need for sedation

Primary outcomes:
measure: Changes of the partial pressure of carbon dioxide (PaCO2) levels
timeFrame: immediately after intervention
Secondary outcomes:
measure: Respiratory Rate ( RR), (b/min)
timeFrame: 90 minutes
measure: Tidal Volume ( TV), (mL)
timeFrame: 90 minutes
measure: Minute Ventilation (VE), (L/min)
timeFrame: 90 minutes
measure: Inspiratory effort quantification
timeFrame: 90 minutes
measure: Transcutaneous carbon dioxide (TcPCO2) and oxygen saturation (SpO2)
timeFrame: 90 minutes
measure: Dyspnea score
timeFrame: immediately after intervention
measure: Comfort
timeFrame: immediately after intervention
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Policlinico di Sant'Orsola
Study officials:
References:
Clinical trial NCT00389389: Phase I, Open-Label, Dose-Escalation Study of AZD4877 in Solid Tumors
Official title: A Phase I, Open-Label, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD4877 Administered Weekly or Every Two Weeks in Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Keywords: Advanced Solid Malignancies
Advanced solid tumors
Cancer
Phase I
Solid tumors
Solid malignancies
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-10-18
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to find out what the maximum tolerated dose is for an experimental drug called AZD4877 based on the side effects experiences by patients that receive AZD4877 on a weekly basis


Eligibility criteria: Inclusion Criteria:

* Advanced solid tumors for which standard treatment doesn't exist or is no longer effective.
* Relatively good overall health other than your cancer.

Exclusion Criteria:

* Poor bone marrow function (not producing enough blood cells).
* Serious heart conditions.
* Poor liver or kidney function.

Primary outcomes:
measure: To identify a maximum-tolerated dose of AZD4877 by assessment of the incidence of dose-limiting toxicities as measured by the Common Terminology Criteria for Adverse Events (CTCAE) grade and type of AEs experienced in the first cycle of treatment.
timeFrame: assessed at each treatment
Secondary outcomes:
measure: Pharmacokinetics parameters of Cmax, AUC and C24 of AZD4877 measured during the first cycle of treatment.
timeFrame: Assessed after the first course of treatment
Other outcomes:
Locations:
city: Denver
country: United States
facility: Research Site
state: Colorado
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Houston
country: United States
facility: Research Site
state: Texas
Study officials:
affiliation: AstraZeneca
name: Judith Ochs, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03957889: Students and Trainers' Evaluations Correlation
Official title: Correlation Between Students' and Trainers' Evaluations While Learning Delegated Surgical Procedures: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgical Procedure, Unspecified
Critical Thinking
Simulation
Evaluation
Lead sponsor: Centre de l'arthrose, Paris
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de la Réunion
First posted: 2019-05-21
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We divided Students into groups of 10 to 12 students, distributed into 5 sessions over the study period. We paid attention to mix these groups according to various places of exercise, surgical skills, length of professional practice and sectors of public or private activities. This group allocation was intended to enrich the exchanges between students by providing diverse personal and professional experiences, while maintaining a balance between the groups.

Brief summary: The delegation of procedures within the medical competence to the nurses can increase the effectiveness of the healthcare provided. The objectives of the study are (1) to assess the quality of training courses for delegated surgical procedures through implementation for graduate scrub nursing ("students") (2) and to evaluate the correlation between the evaluation of this training carried out by students and the self-assessment conducted by the faculty ("trainers").


Eligibility criteria: Inclusion Criteria:

* scrub nurses already in practice
* professional trainer, specialist in the field of the proposed course subject

Primary outcomes:
measure: SFDP26 questionnaire
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: