louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03042364: Cytokine Profile of the Uterine Secretome After Therapeutic Endometrial Scratching
Official title: Cytokine Profile of the Uterine Secretome After Therapeutic Endometrial Scratching
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Female
Keywords: Endometrium, Cytokines, Endometrial secretion, Implantation, Endometrial scratching
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2017-02-03
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: DIAGNOSTIC

Brief summary: This study investigates the impact of endometrial scratching on endometrial secretion, when correlated to pregnancy.


Eligibility criteria: Inclusion Criteria:

* IVF or ICSI patients with ≥1 previous implantation failure, despite transfer of a top quality embryo or blastocyst.
* Antagonist treatment
* FSH: 2-12 IU/L
* BMI: 18-32
* Regular menstrual cycle
* Written consent

Exclusion Criteria:

* Suspected intrauterine abnormalities Planned use of specialized media or AHA

Primary outcomes:
measure: Cytokine profile of the uterine secretome after therapeutic endometrial scratching
timeFrame: Within 12 months
measure: Immunoassay Kit:
timeFrame: Within 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Fertility Clinic,Aalborg University Hospital
city: Herlev
country: Denmark
facility: Fertility Clinic, Herlev Hospital
city: Horsens
country: Denmark
facility: Fertility Clinic Horsens Hospital
city: Skive
country: Denmark
facility: Fertility Clinic, Skive Hospital
Study officials:
References:
Clinical trial NCT00170664: Taxol/ Carboplatin as First Line Therapy in Patients With Epithelial Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Keywords: Ovarian neoplasms
paclitaxel, carboplatin
clinical trials, phase II
first-line chemotherapy
weekly therapy schedule
Lead sponsor: North Eastern German Society of Gynaecological Oncology
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 129
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The combination of paclitaxel and carboplatin in a three weeks schedule has emerged as the current standard approach for the adjuvant treatment of ovarian cancer. Based on a phase I study now a multi-center phase II-trial was conducted.


Eligibility criteria: Inclusion Criteria:

* histologically-confirmed epithelial ovarian cancer of FIGO stage IIB - IV
* life expectancy of more than three months
* ECOG performance status less than 3
* laboratory parameters within the normal range, including a glomerular filtration rate (GFR) greater than 60 ml/min, serum creatinine levels below 1.6 mg/dl, liver transaminases less than two times the normal levels, bilirubin concentrations below 1.5 mg/dl, adequate bone marrow function as indicated by a neutrophil count greater than 1,500/µl, and a platelet count greater than 100,000/µl.
* written informed consent

Exclusion Criteria:

* suffering from secondary malignancy or underlying serious, uncontrolled concurrent medical or psychiatric disease
* radiotherapy within 4 weeks for study entry

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum
Study officials:
affiliation: Charite University, Berlin, Germany
name: Werner Lichtenegger
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01573364: Prevalence and Reversibility of Lung Hyperinflation in Asthma
Official title: Evaluation of the Prevalence and the Reversibility of the Lung Hyperinflation in Uncontrolled Persistent Asthmatic Patients With Dyspnea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: Distal Airways
Hyperinflation
Reversibility
Lead sponsor: Chiesi Farmaceutici S.p.A.
Sponsor class: INDUSTRY
First posted: 2012-04-09
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults

Brief summary: The aim of this observational study is to evaluate the pulmonary hyperinflation and its immediate reversibility to a short acting beta2 agonist test in uncontrolled persistent asthmatic patients with dyspnea.

Detailed description: The other objectives are :

* the evaluation of the hyperinflation defined by an increase of the residual volume (RV),
* the observation of the relationship between the hyperinflation and the asthma characteristics,
* the study of the improvement of the functional parameters after a reversibility test
* the evaluation of the correlation between hyperinflation parameters evolution, chest tightness and dyspnea

Eligibility criteria: Inclusion Criteria:

* Patient with a diagnosis of uncontrolled persistent asthma (ACT \</= 19) or with an MRC score of dyspnea \>/= 1
* Patient requiring a check-up including a pulmonary function test by plethysmography with a reversibility test

Exclusion Criteria:

* Patient participating to an other clinical trial or having participated to a clinical trial with medicine in the last 3 months

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Courbevoie
country: France
facility: Laboratoire Chiesi S.A.
Study officials:
affiliation: Chiesi S.A.
name: Capucine de Meynard, MD
role: STUDY_DIRECTOR
affiliation: Hopital Cochin Paris France
name: Daniel Dusser, MD, Prof
role: STUDY_CHAIR
References:
citation: Perez T, Chanez P, Dusser D, Devillier P. Prevalence and reversibility of lung hyperinflation in adult asthmatics with poorly controlled disease or significant dyspnea. Allergy. 2016 Jan;71(1):108-14. doi: 10.1111/all.12789. Epub 2015 Nov 6.
Clinical trial NCT06148064: EFFECT OF LOW-LEVEL LASER THERAPY ON STABILITY OF DENTAL IMPLANTS PLACED IN A FRESH EXTRACTED SOCKET
Official title: EFFECT OF LOW-LEVEL LASER THERAPY ON STABILITY OF DENTAL IMPLANTS PLACED IN A FRESH EXTRACTED SOCKET
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant Stability
Lead sponsor: University of Alexandria
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of the study was to evaluate the effect of low-level laser therapy (LLLT) (660nm laser diode 0.5W) on implant stability and crestal bone loss in implants inserted in freshly extracted sockets augmented by Collaplug in the jumping gap.


Eligibility criteria: Inclusion Criteria:

* 1. Any non-restorable hopeless tooth: badly decayed tooth that cannot be restored. Tooth with failed endodontic treatment and tooth with longitudinal fracture.
* Type I post-extraction sockets with all bony walls intact.
* No signs of active periodontal disease in the selected tooth.

Exclusion Criteria:

* The presence of any systemic disease that could complicate bone or soft tissue healing after immediate implant placement.
* The presence of acute periapical infection.
* The presence of any local factor that may interfere with extraction as tooth ankyloses.
* Subjects who had undergone therapeutical radiation.
* Patients who had been subjected to or who were under bisphosphonate therapy

Primary outcomes:
measure: Implant stability
timeFrame: up to 3 months
measure: Crestal bone loss
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Alexandria University
name: Nermine A Elnakib, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Alexandria University
name: Maha R Talaab, PhD
role: STUDY_CHAIR
affiliation: Alexandria University
name: Nayrouz A Metwally, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06761664: Decreasing Edema with Platysma Exercises Following Third Molar Extraction Surgery
Official title: Decreasing Edema with Platysma Exercises Following Third Molar Extraction Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Third Molar Extraction
Keywords: Third molar extraction
Platysma muscle
Exercise
Edema
Lead sponsor: Yuksek Ihtisas University
Sponsor class: OTHER
Collaborators: name: Gazi University
name: Ankara University
First posted: 2025-01-07
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the effects of a platysma muscle exercise on edema following third molar extraction surgery.

Detailed description: The investigators hypothesized that, during the muscle contraction of the platysma, the vascular structures will be subjected to a pump effect, leading to an increase in venous circulation. Additionally, due to its connection to the fascia, the investigators propose that platysma contractions may mobilize the fascia and stimulate the lymph nodes, thereby improving interstitial fluid flow. This could lead to an effective treatment option for decreasing edema after third molar tooth extraction. Therefore, this study aims to investigate the effects of platysma exercises applied after third molar tooth extraction on edema while observing the differences on pain and trismus.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-40,
* Those requiring impacted third molar extraction
* Those with no systemic health conditions, were included in the study
* Those who accepted to participate in the study

Exclusion Criteria:

* Those who had systemic diseases
* Those who were taking medications that could interfere with inflammation, or healing,
* Those who were pregnant or breastfeeding,
* Those who had infections or pathologies involving teeth 38 and 48,
* Those who were unable to comply with postoperative recommendations or required therapeutic interventions outside the study protocol

Primary outcomes:
measure: Facial Edema
timeFrame: Change of facial edema from baseline to 7 days
Secondary outcomes:
measure: Pain following third molar extraction
timeFrame: Change in pain scores from baseline to 7 days
measure: Trismus
timeFrame: Change of trismus from baseline to 7 days
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University, Faculty of Dentistry
state: Cankaya
Study officials:
affiliation: Gazi University
name: GOKHAN YAZICI, A/Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06825364: Near-InfraRed Spectroscopy of Auricular Stimulation
Official title: Neural Responses to Tactile Auricular Stimulation Measured by Functional Near-infrared Spectroscopy in Pain-free Volunteers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy Male and Female Subjects
Healthy Volunteer Study
Keywords: auricular stimulation
functional near infrared spectroscopy
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2025-02-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Observational mechanistic study
Primary purpose: BASIC_SCIENCE

Brief summary: This is a single-visit non-invasive study of healthy volunteer subjects. Brain activity will be measured with infra-red light sensors attached to a cap worn on the head, while both ears are gently stimulated with plastic filaments.

Detailed description: The aim of this study is to localize and quantify brain activations from experimental stimulation of auricular points in pain-free volunteers. Investigators will stimulate auricular points for the shoulder, thumb, and lumbar spine with von Frey filaments and measure functional near-infrared spectroscopy (fNIRS) responses in the primary somatosensory (S1) and prefrontal cortex (PFC). This will test the hypothesis that stimulation across different points in the auricular cartography maps to distinct brain responses, an assumption underpinning AT theory. Stimulation of different ear points is anticipated to induce similar PFC responses, but activate distinct areas within the S1 homunculus, validating the concept of auricular cartography.

Eligibility criteria: Inclusion Criteria:

Age of at least 18 years

Exclusion Criteria:

1. frequent or chronic pain requiring the use of pain-relieving medications more than twice per week, on average, in the last 3 months,
2. history or symptoms of neuropathy,
3. active lesions or skin disruptions to either ear,
4. recent (\< 3 mo) illicit drug use,
5. history of substance misuse/abuse,
6. current or recent (\<1 month) opioid or marijuana use, and
7. current regular use of psychoactive prescription medications

Primary outcomes:
measure: fNIRS response, Lumbar spine vs. thumb auricular points
timeFrame: 10 minutes
Secondary outcomes:
measure: fNIRS response, shoulder vs. thumb auricular points
timeFrame: 10 minutes
measure: fNIRS response, lumbar spine vs. shoulder auricular points
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Keith Vogt, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03795064: Immediate Versus Early Endovenous Ablation In Venous Ulcer
Official title: Immediate Versus Early Endovenous Ablation In Venous Ulcer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Ulcer
Keywords: Venous Ulcer
Venous Insufficiency of Leg
Varicose Veins
Lead sponsor: Oulu University Hospital
Sponsor class: OTHER
First posted: 2019-01-07
Enrollment: 23
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: The study is conducted to assess the effects of immediately started foam sclerotherapy in venous ulcer compared to early intervention.

Detailed description: Recently EVRA study showed that early endovenous ablation (foam sclerotherapy and/or endothermal ablation) is beneficial for venous ulcer healing. This randomized controlled trial is conducted to assess the effects of immediate foam sclerotherapy in the first visit to vascular outpatient clinic (immediate intervention). Patients in control group will receive foam sclerotherapy at four weeks (early intervention). Endothermal ablation is performed in early setting in both groups when truncal vein anatomy is suitable. The primary outcome for this study is the reduction of venous ulcer area at four weeks.

Eligibility criteria: Inclusion Criteria:

* Venous ulcer \> 1 month
* Ulcer area \> 1cm2
* Palpable distal pulses / Ankle-brachial index \> 0,8 / Toe-brachial index \> 70mmhg (at least one criteria must be met)

Exclusion Criteria:

* Leg ulcers other than venous etiology
* Pregnancy
* General contraindications for foam sclerotherapy
* Ulcers requiring operation theater revision

Primary outcomes:
measure: Venous ulcer area
timeFrame: 0 to 180 days
Secondary outcomes:
measure: Time to ulcer healing
timeFrame: 0 to 360 days
measure: Total time of active venous ulcer
timeFrame: 0 to 360 days
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital, Vascular Department
Study officials:
References:
Clinical trial NCT05854264: Influence of Nutrition on Lung Microbiota in Traumatic Brain Injury
Official title: Lung Microbiota in Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Microbial Colonization
Lead sponsor: University of Foggia
Sponsor class: OTHER
First posted: 2023-05-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: specialized nutrition group
Primary purpose: DIAGNOSTIC

Brief summary: Role of immunonutrition in modulating the lung microbiota of intubated TBJ patients and how this interaction may affect the infections and outcomes.

For these reasons, the aims of our study are the evaluation of the impact of immunonutrition on the lung microbiota and the relationship between lung microbiota and infection in TBJ patients in ICU.

Detailed description: Traumatic brain injury patients, requiring mechanical ventilation admitted to ICU will be randomly divide in two groups receiving standard nutrition or specialized formula.

Lower lavage (Bronco Alveolar Lavage: BAL) samples will be collected at admission in ICU and at day 7 for the microbiota analysis. Clinical follow-up at day 28 will be obtained

Eligibility criteria: Inclusion Criteria:

* adults (age \> 18 years),
* paziente with traumatic brain injury

Exclusion Criteria:

* pregnant women,
* patients with gastric content inhalation
* patients with chronic inflammatory bowel diseases
* patients underwent major abdominal surgery and/or organs/tissues transplant
* patients on corticosteroid and/or immunosuppressive therapy

Primary outcomes:
measure: infection
timeFrame: pulmonary infection within 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Foggia
country: Italy
facility: Ospedali Riuniti
state: Puglia
Study officials:
References:
Clinical trial NCT06627764: Salud, Estrés y Resilencia en Familias/ Health, Stress, and Resilience Among Latino Families in the US
Official title: Salud, Estrés y Resilencia en Familias/ Health, Stress, and Resilience Among Latino Families in the US
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Substance Abuse
Intimate Partner Violence (IPV)
HIV Infections
Depression
Anxiety
Keywords: Family
Stress
Resilience
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-10-04
Enrollment: 400
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to prevent syndemic health conditions by decreasing acculturative stress and promoting resilience via SER Familia (Salud, Estrés y Resilencia en Familias/ Health, Stress, and Resilience in Families), a family-based intervention. SER Familia is a six-session intervention co-developed and delivered by community health workers (CHWs) that uses strategies to reduce acculturative stress, promote resilience, improve parent-child and family level health, while simultaneously helping families maintain strong social networks and better navigate community resources to address social determinants of health (SDOH). More specifically, investigators aim to: 1) Examine the efficacy of SER Familia to prevent or reduce the syndemic comprised of substance abuse, IPV, HIV risk, depression, and anxiety among Parents and Youth; and 2) Identify how individual, family, and community mechanisms of change related to acculturative stress and resilience mediates the effect of SER Familia.


Eligibility criteria: Inclusion Criteria:

* Eligible participants must identify as Hispanic/Latino/a/x/e,
* be a first generation immigrant parent or parental figure (Parent)
* have a child (Youth) aged 12-17
* speak English and/or Spanish

Exclusion Criteria:

* Families planning to move within two years will be excluded

Primary outcomes:
measure: Change in Parent Acculturative stress as measured by the Hispanic Stress Inventory (HSI-2) Immigrant Version
timeFrame: From Enrollment to end of treatment at 6 weeks
measure: Change in Youth Acculturative stress as measured by the Hispanic Stress Inventory - Adolescent (HSI-A)
timeFrame: From Enrollment to end of treatment at 6 weeks
measure: Change in individual resilience as measured by the 25-item Resiliency Scale
timeFrame: From Enrollment to end of treatment at 6 weeks
measure: Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Global Health
timeFrame: From Enrollment to end of treatment at 6 weeks
Secondary outcomes:
Other outcomes:
measure: Perceptions of the impact of SER Familia on Parents and Youth as measured by semi-structured interviews
timeFrame: From end of treatment at 6 weeks to the end of year two
Locations:
Study officials:
References:
Clinical trial NCT00863564: Acute Effects of Dietary Proteins on Postprandial Lipemia, Incretin Responses and Subclinical Inflammation in Obese Subjects
Official title: Acute Effects of Dietary Proteins on Postprandial Lipemia, Incretin Responses and Subclinical Inflammation in Obese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Postprandial Lipemia
Atherosclerosis
Inflammation
Postprandial Incretins
Keywords: Postprandial Period
Postprandial Lipaemia
Incretins
Subclinical Inflammation
Obesity
Atherosclerosis
Triglyceride
Lipoproteins
Postprandial inflammation
Lead sponsor: Aarhus University Hospital
Sponsor class: OTHER
Collaborators: name: The Danish Obesity Research Centre
name: Nordic Centre of Excellence
First posted: 2009-03-18
Enrollment: 12
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine the effects of dietary protein on blood lipids and gut hormones after a fat-rich meal.

Hypothesis: Certain dietary proteins reduce the amount of fat circulating in the blood stream following a fat rich meal. The effect is dependant of both the quality and the quantity of protein ingested.


Eligibility criteria: Inclusion Criteria:

* BMI \> 30 kg/m2 \& \< 45 kg/m2

Exclusion Criteria:

* Diabetes
* Lipid lowering drugs
* Liver-, Kidney- and/or Heart Disease
* Serious Hypertension (160/110)

Primary outcomes:
measure: Triglyceride
timeFrame: 0h- 2h- 4h- 6h- 8h postprandial
Secondary outcomes:
measure: Incretins
timeFrame: 0h -1h -2h -4h -6h -8h Postprandial
measure: Inflammatory markers
timeFrame: 0h- 1h- 2h- 4h- 6h- 8h postprandial
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Clinical Nutrion
Study officials:
affiliation: Department of Endocrinology and Metabolism, Aarhus University Hospital
name: K Hermansen, Professor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Holmer-Jensen J, Karhu T, Mortensen LS, Pedersen SB, Herzig KH, Hermansen K. Differential effects of dietary protein sources on postprandial low-grade inflammation after a single high fat meal in obese non-diabetic subjects. Nutr J. 2011 Oct 19;10:115. doi: 10.1186/1475-2891-10-115.