louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00265421: Study of Different Suturing Techniques for Perineal Repair After Delivery
Official title: The Danish Suture Trial: a Randomized Trial on Perineal Sutures Following Vaginal Birth.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perineal Lacerations
Episiotomy
Keywords: Suture Techniques
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Danish Research Agency
name: Aase and Ejnar Danielsens Foundation
name: Aarhus University Hospital
name: The Danish Midwifery Organization
name: Sophus Jacobsen and wifes´ Foundation
name: Else and Mogens Wedell-Wedellsborgs´ Foundation
name: Frode V. Nyegaard and wifes´ Foundation
name: K. A. Rohde's and wife's Foundation
First posted: 2005-12-14
Enrollment: 400
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: We wish to determine wich of two standardized suturing techniques is the best for perineal repair if a perineal laceration or an episiotomy is present after vaginal birth.

The participants are healthy primi para and deliver at term.

Detailed description: A randomised controlled trial with 400 participants was initiated in August 2004. The two suture techniques compared were both 2-layered and either continuous sutures or interrupted, inverted stitches to perineal muscles and the subcuticular layer. A polyglactin 910 multifilament thread on an atraumatic needle was used and the perineal skin was left unsutured. Healthy primiparas \>36+0 weeks gestation could participate if they had a either a 2nd degree perineal laceration or an episiotomy.

The trial was a double-blind and analysis was done on an intention-to-treat basis. Main outcomes were pain, wound healing and patient satisfaction.

Eligibility criteria: Inclusion Criteria:

Primipara, 2nd degree perineal laceration or episiotomy. Vaginal birth of one child in occipital position terminating a pregnancy at 36 weeks or later. A soft cup used to deliver the baby was accepted. Participants must be able to understand and speak Danish.

Exclusion Criteria:

Perineal 3rd or 4th degree injuries, post partum haemorrhage extending 1000 ml. or manual removal of placenta, former perineal wounds, foetus mortuus or delivery of a child immediately transferred to the neonatal ward, Diabetes Mellitus, instrumental delivery, Caesarean Section or gemelli.

Primary outcomes:
measure: Pain in perineal area day 1 and 10 after delivery.
measure: Healing of wound day 1 and 10 after delivery.
Secondary outcomes:
measure: Patient satisfaction with perineal sutures performed at birth.
measure: Incontinence.
measure: Need for resuturing of perineal area within 1 year after delivery.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Dept. of Obstetrics and Gynaecology, Skejby Sygehus
Study officials:
affiliation: Aarhus University Hopspital, dept. of Obst. & Gyn.
name: Niels Uldbjerg, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT00370721: Intravitreal Bevacizumab for Management of Active Progressive Proliferative Diabetic Retinopathy (PDR)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Diabetic Retinopathy
Keywords: Proliferative diabetic retinopathy(PDR)
Pan retinal photocoagulation (PRP)
Vitreous hemorrhage
Traction retinal detachment
Neovascularization on disc (NVD)
Neovascularization elsewhere (NVE)
Fibrous proliferation on disc (FPD)
Fibrous proliferaiton elsewhere (FPE)
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2006-09-01
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of intravitreal bevacizumab on the course of diabetic retinopathy in cases with the signs of active progressive PDR


Eligibility criteria: Inclusion Criteria:

* Cases of active progressive PDR with history of scatter laser photocoagulation

Exclusion Criteria:

* history of vitrectomy

Primary outcomes:
measure: Regression of diabetic retinopathy
measure: visual acuity
Secondary outcomes:
measure: neovascularization
measure: fibrous proliferation
measure: traction retinal detachment
measure: vitreous hemorrhage
measure: pan retinal photocoagulation
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Hamid Ahmadieh, MD
Study officials:
affiliation: Ophthalmic Research Center of Shaheed Beheshti Medical University
name: Hamid Ahmadieh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03247621: Exploring the Effects of Social Media Use and Environmental Factors
Official title: External Eating: An Investigation of Social Media and Environmental Factors Influencing Eating Behaviours
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Whatsapp, Article, No Phone
Keywords: external eating, technology
Lead sponsor: Yale-NUS College
Sponsor class: OTHER
Collaborators: name: Raffles Institution
First posted: 2017-08-11
Enrollment: 180
Sex: ALL
Minimum age (years): 13
Maximum age (years): 26
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: In this protocol, the investigators propose a randomised controlled trail to explore the effects of environmental factors and the use of technology on eating behaviours. The investigators have planned two studies to investigate these effects, one on high school students from Raffles Institution, and the other on the university population in the National University of Singapore.

Detailed description: Participants will be told a cover story that the study explores technological distraction on taste, and asked to complete a taste-evaluation taste of common snacks. One group (intervention group) will be asked to use their personal smartphones to engage in their pre-existing Whatsapp chats while doing the taste test. For the two control conditions, one group will be tasked with reading a neutral article on their personal smartphones while they complete the taste test, while the other group will be asked to complete the taste test without any use of smartphones.

Eligibility criteria: Inclusion Criteria:

* Normal weight: Body mass index of 18 to 25
* Have at least occasional breakfast meals (≥ 3 times a week of self-reported consumption of a breakfast meal)

Exclusion Criteria:

* Symptoms / history of any medical or psychiatric conditions
* Allergies to food products
* History of eating disorders
* Excessive exercise (≥ 5 times a week of self-reported exercise)
* Currently on a special diet or deliberating restricting caloric intake
* Currently on a weight loss program
* Smoking or substance abuse

Primary outcomes:
measure: Amount of food consumed
timeFrame: 20 minutes
Secondary outcomes:
measure: Hunger ratings
timeFrame: 10 minutes
measure: Taste ratings
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Yale-NUS College
Study officials:
References:
Clinical trial NCT03856021: Microfracture vs. Microfracture and BMAC for Osteochondral Lesions of the Talus
Official title: Comparing Outcomes of Microfracture Versus Microfracture and Bone Marrow Aspirate Concentrate for the Treatment of Osteochondral Lesions of the Talus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteochondral Lesion of Talus
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 70
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: Osteochondral lesions of the talus are thought to be due in large part to traumatic events or repetitive microtrauma that causes damage to both the articular cartilage and the subchondral bone. There are several treatment modalities for osteochondral lesions of the talus but there is no consensus as to which is the superior method for repair.

Treatment modalities are aimed at regenerating articular cartilage. Microfracture is a widely accepted and utilized treatment for osteochondral lesions. This procedure results in pluripotent bone marrow stem cells filling the defect and ultimately differentiating into fibrocartilage-producing cells \[1\]. This technique has shown good results in both short- and medium-term follow-up for smaller lesions. Bone marrow aspirate contains mesenchymal stem cells and growth factors with cartilage regeneration potential. Bone marrow aspirate concentrate (BMAC) is a treatment modality that has shown to have to potential to produce hyaline cartilage. This study aims to analyze the effect of adding BMAC to the standard microfracture procedure in terms of clinical and radiographic outcomes in comparison to patients who only underwent microfracture treatment.


Eligibility criteria: Inclusion Criteria:

Greater than 18 years of age and scheduled for surgery to treat osteochondral lesion of the talus Able and willing to sign informed consent document

Exclusion Criteria:

Unwilling to sign informed consent document

Primary outcomes:
measure: Foot and Ankle Ability Measure (FAAM)
timeFrame: 3 years following surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03467321: Balance, Pulmonary Function, and Low Back Pain in Pregnant and Non-pregnant Women
Official title: Assistant Professor, Physioterapist, PhD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pregnancy Related
Lead sponsor: Ataturk Training and Research Hospital
Sponsor class: OTHER
First posted: 2018-03-16
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant and non pregnant women

Brief summary: The aims of this study were to investigate balance and pulmonary functions in pregnant and non-pregnant women and to determine their relationship with LBP.


Eligibility criteria: Inclusion Criteria:

* pregnant women (in the second and third trimester), non-pregnant women, aged between 18 and 40 years, volunteering to participate in the study

Exclusion Criteria:

* Having a high-risk pregnancy, preeclampsia, multiple pregnancies, gestational diabetes mellitus, hypertension, any physical disability, prior history of surgery related to spine or abdominal, spinal deformity, serious neurological, rheumatologic, cardiopulmonary or psychiatric diseases, malignancy, fracture history, or those having any exercise program or sportive activity in the last 3 months for pregnant women
* Having any physical disability, spinal or abdominal surgery, spinal deformity, serious neurological, rheumatologic, cardiopulmonary or psychiatric diseases, malignancy, or fracture history, or those having any exercise program or sportive activity in the last 3 months for non-pregnant women

Primary outcomes:
measure: Balance
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Pulmonary function
timeFrame: through study completion, an average of 6 months
measure: Low back pain
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yildirim Beyazit University
Study officials:
affiliation: Ankara Yildirim Beyazıt University
name: Seyda Toprak Celenay
role: STUDY_DIRECTOR
affiliation: Beykent University
name: Yasemin Karaaslan
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Gaziantep
name: Mete Gurol Ugur
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06886321: Prostate Irreversible Electroporation Study
Official title: Evaluation of the Effectiveness of Irreversible Electroporation for the Treatment of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: Focal therapy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 10
Sex: MALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Conventional treatment options for localized prostate cancer include prostatectomy, radiotherapy and active surveillance. However, prostatectomy and radiotherapy carry certain degree of morbidity, including the risks of urinary incontinence, erectile dysfunction and injury to the structures in the proximity. Active surveillance carries the risk of disease progression and psychological distress to the patients. Focal therapy employs the concept of only destroying the significant lesion, resulting in disease cure and improved functional outcome. Among the different options of focal therapy, Irreversible electroporation has evolved over the past decades and can be a reliable treatment option. Our study aims at assess the safety and effectiveness of such treatment in prostate cancer management.


Eligibility criteria: Inclusion Criteria:

* Men aged between 40 - 85 years
* Visible index lesion(s) on MRI
* Found to have localized prostate cancer after MRI-USG fusion targeted biopsy or USG-guided template biopsy: Clinical tumour stage \<=T2, or Gleason score \<=7, or PSA \<= 20 ng/ml

Exclusion Criteria:

* Patients unfit for contrast MRI exam
* Patients with active urinary tract infection
* Patients with bladder pathology including bladder stone and bladder cancer
* Patients with urethral stricture
* Patients with neurogenic bladder and/or sphincter abnormalities
* Patients who fail to give informed consent

Primary outcomes:
measure: 6-month oncological outcome
timeFrame: 6-month after treatment
Secondary outcomes:
measure: 6-month and 12-month functional and oncological outcome
timeFrame: At 6-month and 12-month after treatment
measure: 30-day complications
timeFrame: at 30 day after treatment
measure: Presence of histologically proven prostate cancer recurrence
timeFrame: At 12-month after treatment
measure: PSA change
timeFrame: At 3-month, 6-month, 9-month and 12-month after treatment
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital, the Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Chi Hang Yee, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02162121: Stimulating Catheter for Lumbar Plexus Block: Better Postoperative Analgesia?
Official title: Stimulating Catheter for Lumbar Plexus Block: Better Postoperative Analgesia?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hip Replacement Arthroplasty
Lead sponsor: ASST Gaetano Pini-CTO
Sponsor class: OTHER
First posted: 2014-06-12
Enrollment: 64
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: Stimulating catheters have been introduced to reduce the incidence of secondary failure after continuous peripheral nerve blocks, but they effectiveness over traditional nonstimulating catheters is still controversial. The aim of this prospective, randomized, blinded study is to detect if stimulating catheters improve postoperative compared with conventional non-stimulating catheters.


Eligibility criteria: Inclusion Criteria:

* patients undergoing total hip arthroplasty

Exclusion Criteria:

* diabetes neurological disorders coagulation disorders rheumatoid arthritis chronic opioids therapy allergy to local anesthetic

Primary outcomes:
measure: Local anesthetic consumption
timeFrame: 72h
Secondary outcomes:
measure: Visual Analog scale (VAS) score
timeFrame: 72h postoperatively
measure: Up and Go test
timeFrame: 4th postoperative day
measure: Opioids request
timeFrame: 72h postoperatively
measure: Quadriceps strength
timeFrame: preoperative and 24h, 48h, 72h postoperatively
measure: postoperative nausea and vomiting (PONV)
timeFrame: 72h postoperatively
measure: Needle redirections
timeFrame: During catheter position
measure: Catheter insertion time
timeFrame: During catheter positioning
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto ortopedico Gaetano Pini
Study officials:
affiliation: ASST Gaetano Pini-CTO
name: Gianluca Cappelleri, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03146221: Search for Restenosis Markers in Lower Limb Arteritis
Official title: Search for Restenosis Markers in Lower Limb Arteritis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Restenosis
Lower Limb Arteritis
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-05-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The initial hypothesis of this work is that the genesis and the evolution of the atheromatous plaque are partly controlled at the molecular level and in particular by the microRNAs through their role as regulator of the genes.

The study of the tissue and serum profile over time of specific microRNAs involved in the regulation of atheromatous plaque correlated with clinical data and restenosis imaging will allow to define biological markers of restenosis in the patient with an arteritis of the lower limbs .

This study is a pioneer in the field and it would be imprudent to conclude that a biomarker would be used clinically at the end of this work alone. Nevertheless this study will make a major advance in this topic, in vivo intervention studies with inhibition or over-expression of microRNA will obviously be necessary to confirm the use of these as biomarkers of arteritis of the lower limbs.

Regular assay of reliable biomarkers in arterial patients will ultimately suggest early management to best adapt surgical and medical treatment.


Eligibility criteria: Inclusion Criteria:

* Any person to be surgically treated for arteritis on the femoropoplitetic stage,
* affiliated to a social security scheme,
* informed of the study and not opposed to it.

Exclusion Criteria:

* Any person taken in charge for an arteritis on the femoro-popliteal floor refusing to participate in the study,
* or not being able to express its consent.

Primary outcomes:
measure: Study of the tissue and serum profile of microRNAs by quantification by real-time PCR
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT01612221: Oral N-acetylcysteine for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo
Official title: A Phase II Placebo-controlled Intervention Trial of Oral N-acetylcysteine (NAC) for Protection of Human Nevi Against UV-induced Oxidative Stress/Damage in Vivo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Patients at Risk for Melanoma
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2012-06-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a phase II intervention to propose a new melanoma chemoprevention agent. The investigators believe oxidative stress/damage in nevi is a probable indication for melanoma risk, and propose that reduced melanoma risk in humans can be inferred by protection of nevi from ultraviolet light (UV)-induced oxidative changes. The investigators will 1) evaluate whether administration of NAC around the time of UV exposure will reduce melanoma risk in high-risk patient populations with genetic susceptibility to UV-induced oxidative stress, and 2) examine key genetic variants that will identify which individuals are most likely to benefit from chemoprotection.


Eligibility criteria: Inclusion Criteria:

* Must have at least 2 nevi (each \>6 mm diameter) not clinically suspicious for melanoma that can be biopsied.
* Must be able to receive informed consent and sign an approved consent form that conforms to federal and institutional guidelines.

Exclusion Criteria:

* The patient is a minor (\< 18 years old).
* The patient cannot speak/understand English or Spanish. (NOTE: A Spanish consent form and certified interpreter can be made available if needed)
* The patient is pregnant. (NOTE: All female patients who have not had a hysterectomy and are not post-menopausal (i.e. post-menopausal for 1 year and not of child-bearing potential) will have a urine pregnancy test.)
* The patient is a prisoner, critically or mentally ill, or otherwise incapacitated or considered vulnerable.
* The patient has history of allergic reaction to NAC.
* The patient has history of severe asthma.
* The patient has been taking NAC or any other oral antioxidant.
* The patient has recent history (i.e., 3 months) of sunless tanning (tanning bed) or extensive sunburn.

Primary outcomes:
measure: UV-induced Oxidative Stress in Irradiated and Unirradiated Nevi
timeFrame: 3.5 years
Secondary outcomes:
measure: Transcriptional Markers of UV-induced Oxidative Stress in Nevi
timeFrame: 3.5 years
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute
state: Utah
Study officials:
affiliation: Huntsman Cancer Institute
name: Douglas Grossman, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: