louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02694146: Clinical Trial to Evaluate the Use of Platelet Rich Plasma in Front Hyaluronic Acid in Coxarthrosis
Official title: Clinical Trial Randomized, Double-blind Controlled, Phase III, to Evaluate the Use of Platelet Rich Plasma in Front Hyaluronic Acid in Coxarthrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coxarthrosis
Keywords: platelet-rich plasma (PRP)
hyaluronic acid (Hylan G-F 20).
NSAIDs
WOMAC
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
First posted: 2016-02-29
Enrollment: 74
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy and safety of platelet rich plasma (PRP) in patients with coxarthrosis who don´t respond to treatment with NSAIDs, compared to treatment with hyaluronic acid (Hylan G-F 20).


Eligibility criteria: Inclusion Criteria:

* Patients\> 30 years.
* Patients who voluntarily express their intention to participate by informed consent.
* Diagnosis of coxarthrosis who have failed conservative treatments for 6 months
* Women of childbearing potential must have a negative pregnancy test during screening and must agree to use adequate contraception (or two contraceptive methods, of which one is barrier) while participating in the trial.

Exclusion Criteria:

* Treatment with infiltrations 3 months prior to the study
* Prior treatment with NSAIDs 24h prior to extraction
* Pre-Surgical Treatment of Hip affects
* Diabetics
* Severe liver or kidney disease at the time of extraction
* Thrombocytopenia (\<100,000 platelets / ml) at baseline
* Anemia (Hb 9 \<mg / dl) at baseline
* Hyaluronic acid Allergy
* History crystal arthropathy, inflammatory arthritis or neuropathic arthropathy.
* Acetabular protrusions
* History of infectious arthritis
* Excessive deformity (acetabular dysplasia, Perthes)

Primary outcomes:
measure: EVA scale for pain measure.
timeFrame: Through study completion, an average of 1 year.
measure: Harris Hip Score for pain, function and range of motion measure.
timeFrame: Through study completion, an average of 1 year.
measure: WOMAC questionnaire for pain, stiffness and joint mobility measure.
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
Other outcomes:
measure: Adverse events.
timeFrame: Through study completion, an average of 1 year.
Locations:
city: Pontevedra
country: Spain
facility: Complejo Hospitalario de Pontevedra
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
affiliation: Hospital Universitario Virgen Macarena
name: Luis Javier Roca Ruiz, Graduate
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04118946: Platelet Enriched Plasma for Treatment of Interstitial Cystitis
Official title: Intra Vesical Instillation Versus Submucosal Injection of Platelet Enriched Plasma for Treatment of Interstitial Cystitis/Bladder Pain Syndrome: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Interstitial Cystitis
Bladder Pain Syndrome
Platelet Enriched Plasma
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-10-08
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with diagnosis of Interstitial cystitis/ Bladder pain syndrome
Primary purpose: TREATMENT

Brief summary: A prospective randomized trial will be conducted aiming at evaluation the efficacy and safety of platelet enriched plasma for management of bladder pain syndrome .


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of interstitial cystitis/ Bladder painful Syndrome for more than 3 months will be enrolled

Exclusion Criteria:

* Patients with Anemia, blood disorders, history of pelvic irradiation, pelvic malignancy, and active urinary tract infection unless treated, vesical stone, gynecological disorders e.g. uterine fibroid and neurological disorders will be excluded. Patients less than 18 years old will not be allowed to participate.

Primary outcomes:
measure: efficacy as measured by global response assessment "GRA"
timeFrame: 3 month for each case. Expected time about 18-24 months for whole study period
Secondary outcomes:
measure: safety : rate of complication and grade of complications graded by Dindo-Clavien classification
timeFrame: 3 month for each case. Expected time about 18-24 months for whole study period
measure: incidence of urinary tract infection and gynecological infection among this group
timeFrame: 3 month for each case. Expected time about 18-24 months for whole study period
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Ahmed S EL Hefnawy
Study officials:
affiliation: Assistant professor of urology .Mansoura Urology and Nephrology Center
name: Ahmed El Hefnawy, Msc, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05747846: Pain in Carpal Tunnel Release Wide-awake Local Anesthesia With no Tourniquet vs Local Anesthesia With Tourniquet
Official title: Intraoperative Pain in Carpal Tunnel Release Wide-awake Local Anesthesia With no Tourniquet vs Local Anesthesia With Tourniquet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare pain, satisfaction, and experience between patients who underwent Carpal Tunnel Release with wide-awake local anesthesia no tourniquet technique and local anesthesia with a tourniquet.

Detailed description: The surgical pathology of the hand has grown exponentially. In most cases, the resolution is performed in outpatients with short surgical times. Given the increased demand for this type of surgery, surgeons have sought different variables to reduce the costs and human resources. Thus, the wide-awake local anesthesia no tourniquet procedure (WALANT). It deals with the non-need for anesthetic monitoring and with the regional use of anesthesia with epinephrine.

Its use avoids placing a pneumatic cuff on the arm owing to the vasoconstrictive action of epinephrine. However, the drug takes 25-30 minutes to achieve the maximum hemostatic effect, and adverse effects, such as distal necrosis, have been reported.

Therefore, the technique of local anesthesia without epinephrine with a tourniquet (LA-T) is also used daily by hand surgeons.

The use of a tourniquet, a pneumatic cuff, for less than 20 minutes has been associated with the same or lower pain profiles than the wide-awake local anesthesia no tourniquet without running the risk of adverse effects of epinephrine.

The objective of this study is to compare and assess pain and patient experience after short-duration hand surgery using the WALANT and LA-T techniques. The investigators hypothesized that both types of procedures had a similar level of satisfaction.

Eligibility criteria: Inclusion Criteria:

* Carpal tunnel syndrome with surgical resolution
* Surgical procedures takes less than 30 minutes

Exclusion Criteria:

* Lost follow-up

Primary outcomes:
measure: Pain during surgery
timeFrame: Immediately after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Nicolas M Molho, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05226546: Effectiveness and Safety of Platelet Rich Plasma (PRP) on Persistent Olfactory Dysfunction Related to COVID-19
Official title: Effectiveness and Safety of Platelet Rich Plasma (PRP) on Persistent Olfactory Dysfunction Related to COVID-19: Towards a New Therapeutic Hope
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Anosmia
COVID-19
Keywords: PRP
Anosmia
COVID-19
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Olfactory dysfunction (OD) is a well know symptom of coronavirus disease 2019 (COVID-19), accounting for 48 to 85% of patients. In 1 to 10% of cases, patients develop a chronic olfactory dysfunction (COD,) lasting more than 6 months. Recently, platelet-rich plasma (PRP) was used in patients with non-COVID-19 COD and authors reported encouraging results. In the present study, the investigators investigated the usefulness and safety of PRP injection in 56 patients with COVID-19 COD.

Our results showed that PRP in the olfactory cleft can increase the olfactory threshold one month after the injection. Moreover, our results suggest that timing of treatment may be an important factor and that PRP is a safe treatment because no adverse effects were reported throughout the study


Eligibility criteria: Inclusion Criteria:

* Patient chronic olfactory dysfunction lasting more than 6 months after an infection of COVID-19

Exclusion Criteria:

* Patient under 18 years old
* Patient with blood disorder
* Blood thinner user
* Patient with abnormal findings on nasal endoscopy (e.g., polyposis, rhinosinusitis)

Primary outcomes:
measure: efficity of 1 injection of PRP by Sniffing Sick test compare to a simple olfactory training
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: CHU saint pierre
Study officials:
affiliation: CHU saint Pierre de Bruxelle
name: Mihaela Horoi, PhD
role: STUDY_DIRECTOR
References:
citation: Steffens Y, Le Bon SD, Lechien J, Prunier L, Rodriguez A, Saussez S, Horoi M. Effectiveness and safety of PRP on persistent olfactory dysfunction related to COVID-19. Eur Arch Otorhinolaryngol. 2022 Dec;279(12):5951-5953. doi: 10.1007/s00405-022-07560-y. Epub 2022 Jul 29.
Clinical trial NCT00611546: Perenteral Nutrition and Oxidative Stress in Preterm Infants
Official title: Study of the Oxidant-Antioxidant Effects of Parenteral Nutrition in Preterm Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Infants
Keywords: preterm
parenteral nutrition
TPN
lipid emulsions
photo-protection
oxidative stress
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2008-02-11
Enrollment: 80
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In an effort to decrease the load of peroxides in TPN solutions, multiple studies examined different strategies such as photo-protection, adding multivitamins to the lipid emulsion rather than to the dextrose-amino acid admixture, and adding antioxidants such as glutathione to the TPN solution. However, the role of trace elements as antioxidants, and their interaction with light have not been studied. Also, the impact of TPN-related oxidants on clinical morbidities has not been addressed. Therefore, we aimed in this study of preterm infants to evaluate the role of different components of TPN on urinary peroxides and to examine the biochemical and clinical effects of light protection.


Eligibility criteria: Inclusion Criteria:

Preterm infants included are:

1. with gestational age between 28 to 34 weeks
2. managed with TPN as part of their care in the NICU
3. their postnatal age on enrolment was \< 7 days

Exclusion Criteria:

Infants are excluded if they have:

1. Clinical evidence of sepsis, or a positive blood culture on admission
2. Hepatobiliary dysfunction
3. Persistent metabolic acidosis with base deficit \> 10 mEq / L
4. Renal impairment (urine output \< 1 ml/kg/hour and serum creatinine \> 1 mg/dl)
5. Disseminated intravascular coagulopathy
6. Maternal conditions known to be associated with oxidative stress such as preeclampsia, hypertension and diabetes.

Primary outcomes:
measure: Concentration of peroxides in the urine
timeFrame: 48 hours
Secondary outcomes:
measure: Clinical morbidities (death, and bronchopulmonary dysplasia)
timeFrame: during hospital stay
Other outcomes:
Locations:
Study officials:
affiliation: Mansoura University Children's Hospital
name: Mohamed R Bassiouny, MD
role: STUDY_CHAIR
References:
citation: Bassiouny MR, Almarsafawy H, Abdel-Hady H, Nasef N, Hammad TA, Aly H. A randomized controlled trial on parenteral nutrition, oxidative stress, and chronic lung diseases in preterm infants. J Pediatr Gastroenterol Nutr. 2009 Mar;48(3):363-9. doi: 10.1097/mpg.0b013e31818c8623.
Clinical trial NCT01916746: Treatment of Caesarean Scar Pregnancy
Official title: Safety and Effectiveness of Transvaginal Resection of Pregnancy Tissue in the Treatment of Caesarean Scar Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Caesarean Scar Pregnancy
Keywords: Caesarean Scar Pregnancy
Transvaginal Resection
treatment
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2013-08-06
Enrollment: 150
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to further demonstrate the safety and effectiveness of transvaginal resection of pregnancy tissue in the treatment of Caesarean Scar Pregnancy (CSP).


Eligibility criteria: Inclusion Criteria:

* pre-operative diagnosed as CSP
* hemodynamic stability

Exclusion Criteria:

* cervical pregnancy
* incomplete abortion
* gestational trophoblastic disease
* diagnosis unidentified

Primary outcomes:
measure: The safety of transvaginal resection of pregnancy tissue in the treatment of CSP.
timeFrame: one week
measure: the effectiveness of transvaginal resection of pregnancy tissue in the treatment of CSP.
timeFrame: six months
Secondary outcomes:
measure: Baseline clinical characteristic of patient when diagnosed with CSP
timeFrame: one week
measure: three year recurrence rate
timeFrame: three years after the procedure
Other outcomes:
Locations:
city: GuangZhou
country: China
facility: The First Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Chen Shu-Qin, M.D&PhD.
role: STUDY_DIRECTOR
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Li Jin-Bo, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Yao Shu-Zhong, M.D&Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT02020512: A Study of 0.03% Bimatoprost in the Treatment of Primary Open Angle Glaucoma and Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-12-25
Enrollment: 87
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate 0.03% bimatoprost in the treatment of primary open angle glaucoma and ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of open-angle glaucoma or ocular hypertension
* No use of Lumigan® in the past 3 months

Exclusion Criteria:

* Received laser therapy, glaucoma surgery, cataract surgery, or other ocular surgery within the past 3 months

Primary outcomes:
measure: Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
timeFrame: Baseline, Week 5
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02331212: Role of Hyaluronic Acid in Causing Cancer Stem Cell Growth in the Bones of Patients With Breast Cancer
Official title: Role of Hyaluronic Acid in Cancer Stem Cell Niche
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Carcinoma Metastatic to the Bone
Stage IV Breast Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-01-06
Enrollment: 0
Sex: FEMALE
Minimum age (years): 20
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: Patients with newly diagnosed, histologically confirmed primary and/or metastatic breast cancer

Brief summary: This research trial studies the role of a substance called hyaluronic acid in causing the growth of cancer stem cells in the bones of patients with breast cancer. Cancer stem cells are a type of cancer cells that may cause the cancer to spread to other parts of the body. Studying samples of blood and bone marrow from patients and animal models in the laboratory may help doctors learn more about whether hyaluronic acid affects the growth of cancer in the bones.

Detailed description: PRIMARY OBJECTIVES:

I. To evaluate the hypothesis that there are more hyaluronan synthase 2 (HAS2)+ cells in patients with bone metastasis compared to patients with only local disease.

SECONDARY OBJECTIVES:

I. To evaluate the hypothesis that cells with HAS2+ and cancer stem cell (CSC)+ (cluster of differentiation \[CD\]24-/CD44+/epithelial specific antigen \[ESA\]+) cells will have the most aggressive growth in the bone, using an animal model.

OUTLINE:

Blood and bone marrow samples are collected and analyzed via flow cytometry and polymerase chain reaction (PCR). Cells are also transplanted into mice and studied.

Eligibility criteria: Inclusion Criteria:

* Patients must have newly diagnosed, histologically confirmed primary and/or metastatic breast cancer
* Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document

Exclusion Criteria:

* Patients who have had chemotherapy or radiotherapy

Primary outcomes:
measure: HAS2 expression, measured by single-cell PCR
timeFrame: Baseline
Secondary outcomes:
measure: CSC marker expression
timeFrame: Baseline
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: Kounosuke Watabe
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06387212: 35 kDa Hyaluronan Fragment (HA35) Reduces Chronic Inflammation of Skin
Official title: 35 kDa Hyaluronan Fragment (HA35) Reduces Chronic Skin Inflammation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Skin Inflammation
Cosmetic Skin
Keywords: whitening
pore size
skin dryness
erythema
skin hardness
Lead sponsor: Nakhia Impex LLC
Sponsor class: INDUSTRY
First posted: 2024-04-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To explore the clinical effect and safety of 35 kDa hyaluronic acid fragment ( HA35 ) combined with negative pressure microneedle technology in improving skin problems.


Eligibility criteria: Inclusion Criteria:

* Skin problems include but are not limited to dry skin, dark skin, and coarse pores.
* Chronic skin inflammation, pigmentation, erythema, etc.
* Cooperate with the experimental requirements and be able to complete the score independently。

Exclusion Criteria:

* Pregnant or lactating women.
* Suffering from psychological or mental illness.
* Life is not regular, overeating.
* Hypersensitive to hyaluronic acid, and has a scar constitution.

Primary outcomes:
measure: A skin dryness scale
timeFrame: 120 minutes and 960 minutes
measure: A fair or smooth skin scale
timeFrame: 120 minutes and 960 minutes
measure: A skin pore size scale
timeFrame: 120 minutes and 960 minutes
measure: A inflammatory skin thick hardness scale
timeFrame: 120 minutes and 960 minutes
measure: An erythema color and area scale
timeFrame: 120 minutes and 960 minutes
Secondary outcomes:
measure: Self-satisfaction evaluation
timeFrame: 1 week after the end of the treatment
Other outcomes:
Locations:
city: Ulaanbaatar
country: Mongolia
facility: Nahia Impex LLC
Study officials:
References:
Clinical trial NCT06925412: Sponge Application of MMC Versus Suntenon Injection in Trabeculectomy
Official title: Sponge Application of MMC Versus Suntenon Injection in Trabeculectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trabeculectomy
Glaucoma
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 50
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: Glaucoma is a leading cause of irreversible blindness worldwide, with intraocular pressure (IOP) reduction being the primary therapeutic goal. Trabeculectomy, augmented with mitomycin C (MMC), remains the gold standard surgical intervention but is limited by postoperative fibrosis. MMC delivery methods, including sponge application and sub-Tenon injection, vary in drug distribution and may influence surgical outcomes. This study aimed to compare the efficacy and safety of trabeculectomy using sponge-applied MMC versus sub-Tenon MMC injection, focusing on IOP reduction, bleb morphology, and postoperative medication requirements.

In this retrospective, randomized controlled trial, 50 patients with primary or secondary glaucoma were assigned to trabeculectomy with either MMC sponge application (Group A, n=25) or sub-Tenon MMC injection (Group B, n=25). All surgeries were performed by the same surgeon using standardized techniques. Patients were followed for one year, with primary outcomes including IOP reduction and secondary outcomes encompassing bleb morphology (Indiana Bleb Appearance Grading Scale), bleb integrity (Seidel test), and postoperative glaucoma medication use.


Eligibility criteria: Inclusion Criteria:

* 18 years or older,
* diagnosed with primary open-angle glaucoma (POAG) or secondary glaucoma,
* uncontrolled IOP (IOP \> 21 mmHg) despite maximally tolerated medical therapy,
* progressive visual field deterioration,
* or intolerance to anti-glaucoma medications.

Exclusion Criteria:

* age under 18 years,
* absence of light perception,
* previous incisional glaucoma surgery,
* need for combined ocular procedures,
* intraoperative use of 5-fluorouracil (5-FU),
* or follow-up duration of less than one month

Primary outcomes:
measure: Intraocular pressure (IOP) reduction
timeFrame: One year
Secondary outcomes:
measure: Bleb morphology (Indiana Bleb Appearance Grading Scale)
timeFrame: One year
measure: Bleb integrity (Seidel test)
timeFrame: One year
measure: Postoperative glaucoma medication use
timeFrame: One year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ebsar Eye Center
Study officials:
References: