louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03804086: Evaluation of Advanced PRF Combined With Nano-crystalline Hydroxyapatite for Management of Grade II Furcation Defects
Official title: Clinical and Radiographic Evaluation of Advanced Platelet Rich Fibrin Combined With Nano-crystalline Hydroxyapatite Bone Substitute for Management of Mandibular Molar Grade II Furcation Defects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontitis
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-01-15
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: this study is to evaluate the use of advanced platelet rich fibrin (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OPD) versus open flap debridement alone in the management of mandibular molar grade II defects.

In the management of mandibular molar grade II furcation defects, no difference exists in gain of horizontal clinical attachment level between the use of advanced platelet rich fibrin (A-PRF) + with nano-crystalline hydroxyapatite bone substitute combined with open flap debridement (OPD) and open flap debridement (OPD) alone .


Eligibility criteria: Inclusion Criteria:

Patient-related criteria:

* Systemically healthy patients.
* Compliance with oral hygiene instructions and the maintenance program provided.
* Accepts the 6 months follow-up period.
* Provide informed consent.

Teeth related criteria:

* Mature permanent tooth.
* Asymptomatic mandibular molar with buccal Glickman class II furcation involvement.
* Probing depth (PD) ≥ 5 mm and vertical PD ≥ 3 mm after Phase I therapy (scaling and root planing).
* Presence of radiolucency in the furcation area on an intra-oral periapical radiograph

Exclusion Criteria:

Patient-related criteria:

* Patients taking drugs known to interfere with periodontal wound healing in the last six months.
* Pregnant or nursing women.
* Smokers.
* Uncooperative patients.

Teeth related criteria:

* Teeth with interproximal supra-bony or intrabony defects.
* Teeth with gingival recession.
* Teeth with grade II or III mobility.

Primary outcomes:
measure: Relative Vertical Clinical Attachment Level (RVCAL)
timeFrame: 6 months
Secondary outcomes:
measure: Relative Horizontal Clinical Attachment Level (PHCAL)
timeFrame: 6 months
measure: Probing Depth (PD)
timeFrame: 6 months
measure: Gingival margin Level (GML)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02606786: Effectiveness of Lumbopelvic Stabilization Exercises for Pregnancy-related Low Back Pain
Official title: Effectiveness of Lumbopelvic Stabilization Exercises for Pregnancy-related Low Back Pain
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Pregnancy-related Low Back Pain
Keywords: stabilization exercises
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
First posted: 2015-11-17
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effectiveness of lumbopelvic stabilization exercises on women who have undergone Caesarian sections on: 1) disability using the Modified Oswestry Low Back Disability Index (OSW), 2) pain according to the Numeric Pain Rating Scale (NPRS), 3) percent change of muscle thickness of the deep abdominals using ultrasound imaging, and 4) perceived improvement using the Global Rating of Change (GROC).

Detailed description: Pregnancy-related low back pain is a very complex problem. Decreased strength and endurance in the trunk and hip muscles have been shown in those with pregnancy-related low back pain. Lumbopelvic stabilization exercises have been shown to decrease pain and disability in those with low back pain. However, there have been very few studies with post-partum women, specifically those who have undergone Caesarian section births.

The purpose of this study is to examine the effectiveness of lumbopelvic stabilization exercises on women who have undergone Caesarian sections on: 1) disability using the Modified Oswestry Low Back Disability Index (OSW), 2) pain according to the Numeric Pain Rating Scale (NPRS), 3) percent change of muscle thickness of the deep abdominals using ultrasound imaging, and 4) perceived improvement using the Global Rating of Change (GROC).

Eligibility criteria: Inclusion Criteria:

* Unilateral low back pain near the sacro-iliac joint (SIJ) (distal and/or lateral to L5-S1 in the buttocks) and/or symphysis pubis
* Pain onset during pregnancy or within 3 weeks of delivery
* Most recent delivery within 6-24 weeks
* At least 2/6 positive SIJ provocation tests (thigh thrust, sacral compression, sacral distraction, sacral thrust, Gaenslen's test)
* Positive active straight leg raise (ASLR) test.

Exclusion Criteria:

* Neurological signs
* Systemic disease
* Currently pregnant

Primary outcomes:
measure: Change in Modified Oswestry Low Back Pain Questionnaire
timeFrame: 4 weeks, 12 weeks
Secondary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 4 weeks, 12 weeks
measure: Ultrasonographic measurements
timeFrame: 4 weeks, 12 weeks
measure: Participant perceived level of improvement
timeFrame: 4 weeks, 12 weeks
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Texas Woman's University
state: Texas
Study officials:
affiliation: Texas Woman's University
name: Kelli J Brizzolara, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03892486: Polyunsaturated Fatty Acids Supplementation and Blood Metabolome
Official title: Analysis of the Effect of a Diet Enriched With Polyunsaturated Fatty Acids on the Proteomic and Metabolomic Profiles of Blood Plasma of Healthy People Aged 18-50
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Keywords: metabolomics, proteomics, PUFA, nutrition
healthy people aged 18-50
Lead sponsor: Poznan University of Life Sciences
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Analysis of the effect of dietary intervention based on increased polyunsaturated fatty acid intake on health. Specifically changes in blood lipid profile, as well as proteomic and metabolomic profiles of healthy adults will be analyzed.


Eligibility criteria: Inclusion Criteria:

* good health,
* proper body weight
* not meeting the needs for polyunsaturated fatty acids

Exclusion Criteria:

* increased body weight,
* limited communication to an extent that makes it impossible to carry out a food interview,
* eating disorders (according to food history),
* metabolic diseases,
* pregnancy,
* lactation,
* taking drugs that influence the metabolism of lipids or carbohydrates

Primary outcomes:
measure: Nutrient intake
timeFrame: 12 weeks
measure: Concentrations of lipoproteins and glucose
timeFrame: 12 weeks
measure: Proteomic analysis of plasma
timeFrame: 12 weeks
measure: Metabolite concentrations in plasma
timeFrame: 12 weeks
Secondary outcomes:
measure: Body mass
timeFrame: 12 weeks
measure: Height
timeFrame: 12 weeks
measure: Percentage body fat
timeFrame: 12 weeks
measure: Waist circumference
timeFrame: 12 weeks
measure: hip circumference
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Poznań
country: Poland
facility: Poznan University of Life Sciences
Study officials:
affiliation: Poznan University of Life Sciences
name: Agata Chmurzynska, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02175186: Effect of ALBIS on Gastroduodenal Mucosal Injury in Patients Receiving Dual Antiplatelet Therapy After Percutaneous Coronary Intervention
Official title: Protective Effect of ALBIS on Gastroduodenal Mucosal Injury in Patients Receiving Dual Antiplatelet Therapy After Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gastritis
Gastroduodenal Ulcer
Keywords: Gastritis
Gastroduodenal Ulcer
Percutaneous Coronary Revascularization
Dual Antiplatelet Therapy
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2014-06-26
Enrollment: 47
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
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 evaluate effectiveness of ALBIS on Gastroduodenal Mucosal Injury in Patients Receiving Dual Antiplatelet Therapy after Percutaneous Coronary Intervention.


Eligibility criteria: Inclusion Criteria:

* Age between 20 and 80 years
* Patients undergoing percutaneous coronary intervention and need to take dual antiplatelet therapy continuously at least 12weeks
* Modified Lanza Score grade 0-1 measured by upper gastrointestinal endoscopy
* mild gastrointestinal symptom
* Creatinen in blood ≤ 3mg/dl
* BUN ≤ 50mg/dl
* Birilubin ≤ 3mg/dl
* AST and ALT ≤ 80U/L

Exclusion Criteria:

* Pregnant or breast feeding
* History of Stomach or esophagus surgery
* Peptic ulcer or reflux esophagitis
* Zollinger-Ellison syndrome or primary esophageal motility disorders
* Malignant tumor
* Bleeding tendency or coagulopathy
* Contraindication of ALBIS
* Long term use of aspirin or P2Y12 receptor antagonist within 1month
* Patients who tool medicine such as PPI, APA,H2blocker, Muscarine receptor antagonist, anti-gastic agent, antacid, anticaogulant, Bisphosphonate agents, Cytotoxic drug, NSAID, adrenal cortex hormone agents (topical treatment is allowed)
* Terminal patient

Primary outcomes:
measure: Incidence of gastric ulcer
timeFrame: 12weeks
Secondary outcomes:
measure: Incidence of gastritis
timeFrame: 12weeks
measure: The Endoscopic improvement rate of hemorrhage
timeFrame: 12weeks
measure: The Endoscopic improvement rate of subjective symptom
timeFrame: 12weeks
measure: Total amount of antacid used during study period
timeFrame: 12weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Songpa-Gu
Study officials:
affiliation: Asan Medical Center
name: Young-Hak Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03991286: The Effect of Astaxanthin on Oxidative Stress Indices in Patients With Polycystic Ovary Syndrome
Official title: The Effect of Astaxanthin on Oxidative Stress Indices in Serum, and Induction of Signaling Pathways in Granulosa Cells in Patients With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PCOS
Keywords: PCOS
Astaxanthin
ROS
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2019-06-19
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Polycystic ovary syndrome (PCOS) is the most common endocrinopathy affecting women of reproductive age It is hypothesized that ∼20 fold increase in reactive oxygen species (ROS) generation in Follicular fluid (FF) and granulosa cells of PCOS women plays an adverse role in affecting the IVF success rate. Astaxanthin (3,3'-dihydroxy-β,β'-carotene-4,4'-dione) is a nonprovitamin A carotenoid classified as a xanthophyll and is found in high amounts in the red pigment of crustacean shells (e.g., crabs, shrimp), salmon, trout, and asteroides. It has been demonstrated that astaxanthin displays a wide variety of biological activities, including anti-oxidative, anticancer, and anti-inflammatory effects.

investigators aim to investigate the effect on Astaxanthin administrating on reducing of ROS in FF and induction of antioxidant response elements in PCOS women.


Eligibility criteria: Inclusion Criteria:

Diagnosed PCOS cases according to the National Institute of Health criteria (NIH consensus criteria) and Rotterdam criteria

Exclusion Criteria:

* Menopause, pregnant or lactating females
* individuals with diabetes
* those with hepatic,renal, thyroid or cardiovascular disorders
* patients with elevated levels of prolactin
* those who were taking antioxidant supplements within the last 3 months

Primary outcomes:
measure: Serum and follicular fluid oxidative stress biomarkers levels
timeFrame: 8 months
Secondary outcomes:
measure: Number of oocytes retrieved
timeFrame: Day1(from the day of oocyte retrieval to fertilization confirmation)
measure: Number of mature(MII) oocyte
timeFrame: Day1(from the day of oocyte retrieval to fertilization confirmation)
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Shariati Hospital
Study officials:
affiliation: Tehran University of Medical Sciences
name: Fardin Amidi, professor
role: STUDY_CHAIR
References:
citation: Gharaei R, Alyasin A, Mahdavinezhad F, Samadian E, Ashrafnezhad Z, Amidi F. Randomized controlled trial of astaxanthin impacts on antioxidant status and assisted reproductive technology outcomes in women with polycystic ovarian syndrome. J Assist Reprod Genet. 2022 Apr;39(4):995-1008. doi: 10.1007/s10815-022-02432-0. Epub 2022 Mar 3.
Clinical trial NCT06171386: Microneedling vs Dermabrasion for Early Facial Scar Resurfacing
Official title: Microneedling vs Dermabrasion for Early Facial Scar Resurfacing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Scar
Keywords: Dermabrasion
Microneedling
Surgical scars
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2023-12-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be invited to participate in the study through the clinic setting - aim to have around 30 patient volunteers. Of the 30 patients, 15 will be randomized to receive microneedling, and 15 will receive dermabrasion.
Primary purpose: TREATMENT

Brief summary: This study aims to determine whether microneedling or dermabrasion in the early post-operative period is superior in improving the appearance of surgical scars on the face.

Detailed description: Microneedling and dermabrasion are two common modalities that may be performed in-office to treat surgical scars.

Microneedling is a form of collagen induction therapy, often used in conjunction with platelet-rich plasma or hyaluronic acid.

Dermabrasion is a technique that improves the skin structure, quality, and appearance of scars through collagen remodeling and reepithelization.

To determine which modality is most effective, a prospective study; randomizing a volunteer sample of adult patients with new surgical vertical forehead scars will receive either dermabrasion or microneedling in the early postoperative period.

Eligibility criteria: Inclusion Criteria:

* Volunteer adult patients will be identified by visiting the Facial Plastics and Reconstructive Surgery Clinic at Atrium Health Wake Forest Baptist.
* Patients will be 18 years old+ and have a vertical surgical scar in the superior 1/3 of the face (trichion to glabella).
* Patients will enroll in the clinic research registry and indicate an interest in being involved in the study.

Exclusion Criteria:

* Patients who rate Types 4-6 on the Fitzpatrick scale will be excluded due to risk of poor outcome from dermabrasion.
* There are no other planned exclusion criteria. Patients will not be excluded on the basis of gender, race/ethnicity, or age, provided that they meet the described inclusion criteria.

Primary outcomes:
measure: Change in Vancouver Scar Scale Scores
timeFrame: Month 7
measure: Change in Patient and Observer Scar Assessment Scale Scores
timeFrame: Month 7
measure: Change in Global Aesthetic Improvement Scale Scores
timeFrame: Month 7
Secondary outcomes:
measure: Patient perceived benefit
timeFrame: At time of procedure (pain scale); at 6 months (yes/no)
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Candace M Water, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06277986: Early Diagnosis of Gastric Cancer Cachexia
Official title: Clinical Value of Tumor Cell-derived Exosomal miRNA in Early Diagnosis of Gastric Cancer Cachexia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cachexia
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The research object is patients with confirmed gastric cancer.According to diagnostic criteria, patients are divided into cachexia group and non-cachexia group.

Brief summary: Gastric cancer is one of the most common malignancies, the morbidity and mortality of which are among the highest. In cancer patients, the incidence of cachexia is very high, and even 80% of patients will eventually develop into cachexia. However, once gastric cancer patients develop cachexia, patients are unlikely to obtain clinically significant benefits from conventional treatment. Therefore, it is important to find biomarkers for early detection of cachexia. The investigators carried out a plasma-derived exosomal microRNA(miRNA) study for early diagnosis of cachexia in gastric cancer, and the development of early diagnosis kits for gastric cancer cachexia.

Detailed description: Gastric cancer is one of the most common malignancies, the morbidity and mortality of which are among the highest. In gastric cancer patients, the incidence of cachexia is very high, and even 80% of patients will eventually develop into cachexia. However, once gastric cancer patients develop cachexia, patients are unlikely to obtain clinically significant benefits from conventional treatment. Therefore, it is important to find biomarkers for early detection of cachexia. The investigators carried out a plasma-derived exosomal microRNA(miRNA) study for early diagnosis of cachexia in gastric cancer, and the development of early diagnosis kits for gastric cancer cachexia.

Eligibility criteria: Inclusion Criteria:

1. Patients with gastric cancer diagnosed by histopathology or cytopathology
2. Complete clinical and pathological data
3. No previous or current mental illness or disturbance of consciousness

Exclusion Criteria:

1. With multiple tumors or other malignant diseases
2. Combined with other chronic wasting and metabolic diseases
3. Past patients with non-tumor cachexia
4. People with mental illness or unable to cooperate

Primary outcomes:
measure: BMI
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Fourth Military Medical University
state: Shaanxi
Study officials:
References:
Clinical trial NCT06755086: TF-antigen Targeting Molecular Probe for PET Imaging in Solid Tumors
Official title: TF-antigen Targeting Molecular Probe for PET Imaging in Solid Tumors
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Solid Tumors
Keywords: Solid Tumors
TF-antigen
CD176
PET imaging
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2025-01-01
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Malignant tumor patients or suspected patients

Brief summary: The objective of the study is to construct a noninvasive approach using 124I-labeled monoclonal antibody radiotracer to detect the Thomsen-Friedenreich antigen (TF-antigen, CD176) expression of tumor lesions in patients with solid tumors and to identify patients benefiting from TF-antigen targeting treatment.

Detailed description: Analysis plan: 1. Recruit 3-5 participants to analyze preliminary pharmacokinetic/first-in-human dose (FIH), major organ distribution, and tumor uptake information via whole-body PET/CT imaging; 2. Recruit 20 participants to analyze in vivo safety and tumor targeting information; 3. Recruit all participants for a final summary.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 and ≤ 75 years, male or female;
2. ECOG performance status score of 0 or 1;
3. Expected survival time ≥ 6 months;
4. At least one measurable tumor lesion exists according to RECIST 1.1 criteria (e.g., lung cancer, gastric cancer, colorectal cancer, breast cancer, pancreatic cancer, hepatocellular carcinoma). The lesion must be eligible for biopsy within one month before or after a PET scan, and the patient must be able to provide 2-3 tissue slices of the lesion;
5. Subjects must fully understand and voluntarily agree to participate in the study and sign an informed consent form.

Exclusion Criteria:

1. Pregnant or breastfeeding women, or women planning to become pregnant during the study period or within three months after drug administration, as well as individuals donating sperm or eggs;
2. Individuals known or suspected to be allergic to the investigational drug or any of its components;
3. Individuals with significantly impaired liver or kidney function;
4. Individuals unable to comply with PET examinations or those with conditions such as claustrophobia that prevent them from undergoing PET scans.

Primary outcomes:
measure: Standardized uptake value（SUV）
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04841486: First Trimester of Pregnancy: Impact of a History of Miscarriage on Women's Stress
Official title: First Trimester of Pregnancy: Impact of a History of Miscarriage on Women's Stress
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy
Keywords: pregnancy
women's stress
history of spontaneous termination of pregnancy
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 93
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women

Brief summary: Miscarriage is the spontaneous termination of pregnancy before 22 weeks of amenorrhea. The most frequent complication of pregnancy, it represents 10 to 25% of pregnancies and affects one in four women.

Miscarriage is considered by medical personnel to be common and trivial. however, for women, it is very often a traumatic event, a source of worry for futures pregnancies.

Detailed description: The aim of the study is to evaluate association between history of spontaneous termination of pregnancy and women's stress during the first trimester of pregnancy.

Eligibility criteria: Inclusion Criteria:

* female
* pregnant (positive plasma HCG)
* in the first trimester of pregnancy
* aged 18 years old and more
* agreeing to participate in the study

Exclusion Criteria:

- less than 18 years old

Primary outcomes:
measure: Women's stress
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Université de Reims Champagne-Ardenne
Study officials:
affiliation: Université de Reims Champagne-Ardenne - CHU de Reims
name: Sandra CARRAU-TRUILLET, MD
role: PRINCIPAL_INVESTIGATOR
References: