louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05565157: Flapless Zygomatic Implants Robot-assisted Placement
Official title: Flapless Zygomatic Implants Robot-assisted Placement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Zygomatic Implant
Robotic
Keywords: zygomatic implant
robotic
flapless
mini-invasive
ROSA
immediate loading
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 15
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: Zygomatic implants are indicated for the rehabilitation of the severely atrophic maxilla. Similar to standard implant placement, gaining an optimal position of the zygomatic implants is essential for a predictable prosthetic-driven treatment outcome.

However, there is no effective mechanism to physically control the drilling trajectory for the zygomatic implants. Therefore, deviation between the actual and planned implant position is inevitable.

This approach is technically difficult, and is performed by an experienced surgeon.

The development of a surgical technique that is both safer and less invasive is currently possible thanks to robotics. In this project, a robotic assisted new strategy for positioning zygomatic implants will be performed and its efficacy and accuracy will be assess.

Path planning will be carried out on a pre-operative scanner. The ROSA robot (Zimmer®) will guide the several drillings steps. Placement of the zygomatic implant will be performed manually.


Eligibility criteria: Inclusion Criteria:

* Patients suffering from Maxillary edentulism with severe bone resorption
* Patients suffering from maxillary edentulism post maxillary defect (carcinologic or traumatic) and free flap reconstruction
* Patients suffering from post-maxillectomy buccosinusal communication.
* Age ≥ 18 years old
* Having signed the informed consent

Exclusion Criteria:

* Patients suffering from chronic sinusitis
* Patients refusing ROSA robot-guided surgery (unsigned informed consent).
* Pregnant and nursing women

Primary outcomes:
measure: Variation rate between theoretical intraoperative position and post-operative zygomatic implants position
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT06969157: Diagnosis and Its Procedural Pattern Among Patients Who Underwent Surgery at Aloha Medical Mission in Dhankuta, 2018
Official title: Diagnosis and Its Procedural Pattern Among Patients Who Underwent Surgery at Aloha Medical Mission in Dhankuta, 2018
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery With General Anesthesia
Lead sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 225
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing surgery (major or minor) during the study period

Brief summary: This was a retrospective, cross-sectional study of the Aloha medical mission in 2018, which involved analyzing recorded data on the sociodemographic profiles of patients, diseases, and surgical procedures. The data of patients was recorded using a pro forma, then entered into Excel and a coding list, and the data analysed using EZR.


Eligibility criteria: Inclusion Criteria:

* patients with complete records of age, gender, diagnosis, procedure performed, anesthesia type, perioperative complications and direct cost per patient.

Exclusion Criteria:

* patients with missing records

Primary outcomes:
measure: frequency and distribution of surgical conditions
timeFrame: Through hospital stay, up to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Tribhuvan University Teaching Hospital
Study officials:
References:
Clinical trial NCT01979757: Outcomes After Centrifugation Versus PureGraft for Fatgrafting to the Breast
Official title: Outcomes After Centrifugation Versus PureGraft for Fatgrafting to the Breast After Breast-conserving Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fatgrafting to a Breast After Breast Conserving Therapy
Lead sponsor: Bulovka Hospital
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Breast-conserving treatment (BCT) leads to a progressive and deteriorating breast deformity. Fatgrafting is ideal for breast reconstruction after BCT. The most frequently utilized technique for fat processing is centrifugation. The PureGraft device (Cytori Therapeutics, USA) is a new method that involves washing and filtering the fat to prepare the graft. The investigators compared the subjective and objective outcomes of two fat-processing methods, centrifugation and PureGraft filtration.

Thirty patients underwent breast reconstruction performed by a single surgeon (OM) after BCT in our department between April 2011 and September 2012. The patients were preoperatively divided into two groups randomly: 15 received fatgrafts processed by centrifugation, and 15 received fatgrafts processed by washing in PureGraft bags. The patients were followed up for 12-30 months.To measure the subjective outcome, the investigators distributed the BREAST-Q questionnaire to all the patients both preoperatively and one year postoperatively. The BCCT.core software evaluated the objective outcome of breast reconstruction by fatgrafting.


Eligibility criteria: Inclusion Criteria:

* State after breast conserving therapy

Primary outcomes:
measure: Outcomes after centrifugation versus PureGraft for fatgrafting to the breast after breast-conserving therapy
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Bulovka Hospital
Study officials:
affiliation: Charles University
name: Ondrej Mestak, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT04692857: US-guided FICB After Hip Fracture: the Effect of the Local Anesthetic Volume on the Quality of Preoperative Analgesia
Official title: Ultrasound-guided Fascia Iliaca Compartment Block After Hip Fracture : the Effect of the Local Anesthetic Volume on the Quality of Preoperative Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fractures
Lead sponsor: University Tunis El Manar
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 75
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: participants were randomly divided into three groups : group 30 , group 40 and group 50 . for all the three groups an ultrasound guided supra-inguinal fascia iliaca block had been performed.

for group 30 ,a volume of 30 ml of 0,2 % ropivacaine had been injected for group 40 ,a volume of 40 ml of 0,2 % ropivacaine had been injected for group 50 ,a volume of 50 ml of 0,2 % ropivacaine had been injected

Detailed description: participants were randomly divided into three groups : group 30 , group 40 and group 50 . for all the three groups an ultrasound guided supra-inguinal fascia iliaca block had been performed.

A linear ultrasound probe was placed in the sagittal plane to obtain an image of the superior iliac spine.the fascia iliaca and sartorious,iliopsoas,and oblique internal muscles were identified by sliding the probe medially. After identifiying the "bow-tie sign"formed by the muscle fascias , an 50 mm needle was introduced 1-2 cm inferior to the inguinal ligament.using an in-plane approch, the fascia iliaca was penetrated and hydrodissected , separating the fascia iliaca from the iliac muscle. in this created space a total volume of 30 ml, 40ml or 50ml of 0.2% ropivacaine was injected , respectively to group 30 ,group 40 and group 50 .

pain score at rest and with a straight leg raise of the affected limb to 15 degrees were assessed before and 30 minutes after block performance.

Eligibility criteria: Inclusion Criteria:

* patients aged above 65 years , american society of anesthesiologists physical status I to III , and with body mass index (BMI) of 35 kg/m² or less , undergoing hip fracture surgical repair .

Exclusion Criteria:

* inability or refusal to sign informed consent
* younger than 65 years
* BMI greater than 35 kg/m²
* presence of contraindications for regional nerve block or spinal anesthesia
* impaired cognition or dementia
* multiple fractures

Primary outcomes:
measure: change in pain score on movement
timeFrame: before and 30 minutes after block placement
Secondary outcomes:
measure: change in pain score at rest
timeFrame: before and 30 minutes after block placement
measure: assessement of sensory block
timeFrame: 30 minutes after block placement
Other outcomes:
Locations:
city: Nabeul
country: Tunisia
facility: Mechaal Benali
state: Mrezga
Study officials:
affiliation: university manar Tunis tunisia
name: mechaal benali, PROFESSOR
role: STUDY_CHAIR
References:
Clinical trial NCT06195657: Pre-operative Localization of Ground Glass Solitary Pulmonary Nodules
Official title: Pre-video Assisted Thoracoscopy Surgery (VATS) Localization of Ground Glass Solitary Pulmonary Nodules: the Sliding Wire Technique
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Neoplasms
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 54
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: Patients of the university hospital of Nice, France

Brief summary: Objectives: The main drawback of the hook-wire technique for locating ground glass nodules before video assisted thoracoscopic surgery (VATS) resection is the risk of the hook dislodging during single lung ventilation as the lung collapses. In order to reduce the friction of the thread in the wall, the investigators modified the technique by first positioning a catheter in the chest wall and introducing the carrying needle through the catheter. The objective was to evaluate the success rate and complications of this technique.

Material and Methods : the investigators retrospectively included all patients undergoing VATS resection of solitary lung nodules after localization using the sliding wire technique.


Eligibility criteria: Inclusion Criteria

- All patients who underwent VATS for pulmonary nodule resection in the thoracic surgery department of Nice University hospital after pre-operative hook-wire insertion using the sliding-wire technique

Exclusion criteria: None

Primary outcomes:
measure: Success rate of the procedure
timeFrame: Up to 4 hours
Secondary outcomes:
measure: Complications
timeFrame: Up to 4 hours
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU NICE
state: Alpes Maritimes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Bernard Padovani
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00453557: Mechanism of Growth Hormone Effects on Adipose Tissue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity
Keywords: growth hormone, obesity, visceral adiposity
Lead sponsor: Pennington Biomedical Research Center
Sponsor class: OTHER
First posted: 2007-03-29
Enrollment: 30
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Growth hormone treatment in humans has been shown to decrease body fat. This study aims to determine what adipose tissue depots are affected by GH and what is the mechanism.

Detailed description: Growth hormone (GH) replacement in GH deficient adults results in an improvement in metabolic status, an increase in lean body mass and a reduction in visceral adiposity. GH might also decrease visceral adiposity in obese adults that are not GH deficient.

The objective of the study is to determine the effects of GH on the metabolic syndrome and visceral adiposity in men with low blood levels of IGF-1 and the durability of these effects after stopping GH therapy. We will use a double blind, placebo controlled 6 month intervention trial followed by a blinded follow-up period of 6 months. Thirty non-diabetic middle aged men with central adiposity (BMI \> 27 kg/m2, waist circumference \> 102 cm) will participate.

Eligibility criteria: Inclusion Criteria:

* Male, aged 40-70
* Central obesity defined as waist circumference greater than 102 cm and BMI \> 27 and \< 35 kg/m2
* No weight loss in last 12 months
* Total IGF-1 level \< 241 ng/ml (\~25th percentile for the assay)
* Body habitus which permitted accurate CT scan acquisition and analysis.

Exclusion Criteria:

* Significant neurologic, metabolic, endocrine, cardiac, respiratory or gastrointestinal disease
* Diabetes
* Known coronary heart disease
* Exercised more than 3 hours per week
* Unwilling or unable to abstain from alcohol for 72 hours prior to the measurements of energy expenditure and fasting blood work

Primary outcomes:
measure: body composition at baseline, after 6 months of treatment and at the end of the followup period
measure: energy expenditure at baseline, after 6 months of treatment and at the end of the followup period
Secondary outcomes:
measure: gene expression in adipose tissue at baseline and after 6 months of treatment
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
Study officials:
affiliation: Pennington Biomedical Research Center
name: Steven R Smith, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04456257: The Efficacy of 1,064-nm Picosecond Laser With Microlens Array for the Treatment of Abdominal Striae Distensae
Official title: The Efficacy of 1,064-nm Picosecond Laser With Microlens Array for the Treatment of Abdominal Striae Distensae
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Striae Alba
Keywords: striae alba, fractional picosecond laser, stretch marks
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2020-07-02
Enrollment: 12
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the efficacy and safety of a fractional 1,064 nm picosecond laser for the treatment of striae alba.

Detailed description: Striae distensae are atrophic dermal scars that can cause psychosocial distress on affected patients. Despite numerous available therapeutic modalities, no gold standard therapy has been established. Picosecond lasers are a newer advancement in lasers that have primarily used in the treatment of tattoos. A fractional 1064-nm picosecond laser has recently become available for the treatment of pigmentation and skin rejuvenation. The main mechanism of action is tissue ablation via laser induced optical breakdown (LIOB) which occur when pulse intensity is high enough to strip electrons and generating plasma, the plasma absorbs the remaining laser energy forming a cavitation bubble within the dermis which has been demonstrated to improve fine wrinkles and acne scar through the stimulation of collagen formation.

Eligibility criteria: Inclusion Criteria:

* Striae alba on abdomen for more than 3 months
* Fitzpatrick skin type III-V

Exclusion Criteria:

* Pregnancy and breastfeeding
* Previous topical treatment, filler injection, chemical peel or laser treatment within 6 months before starting the study
* History of using Isotretinoin
* Photosensitive dermatoses, Infection, eczema
* Past history or family history of malignancy
* History of herpes infection
* History of hypertrophic scar or keloid, connective tissue disease
* History of collagen or elastin disease
* History of smoking
* Significant fluctuations in weight in the past 6 months

Primary outcomes:
measure: Change in striae roughness by Antera 3D image
timeFrame: change from baseline in striae roughness score at 6 months
measure: Change in average Melanin index by Antera 3D image
timeFrame: change from baseline in average melanin index at 6 months
measure: Change in melanin variation index by Antera 3D image
timeFrame: change from baseline in melanin variation index at 6 months
Secondary outcomes:
measure: Investigator assessment scores
timeFrame: Baseline, 1, 3 and 6 months after final treatment
measure: Patient satisfaction scores
timeFrame: Baseline, 1, 3, and 6 months after final treatment
Other outcomes:
Locations:
city: Bangkok Noi
country: Thailand
facility: Faculty of Medicine, Siriraj hospital, Mahidol University
state: Bangkok
Study officials:
References:
Clinical trial NCT01271257: Pharmacokinetics of Misoprostol With Titrated Oral Administration
Official title: Phase 1 Study of Titrated Oral Misoprostol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypotonic; Labor
Keywords: misoprostol, pharmacokinetics
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
First posted: 2011-01-06
Enrollment: 10
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The AUC240, AUC360, and AUC480 of titrated oral misoprostol are greater than traditional oral misoprostol.

Detailed description: The primary outcomes measures of the study are the area under the curve of serum concentration of misoprostol acid against time up to 240, 360 and 480 minutes.

Eligibility criteria: Inclusion Criteria:

* 20-40 Y/O healthy and non-pregnant woman

Exclusion Criteria:

* heart, liver or kidney disease, anaphylaxis to misoprostol

Primary outcomes:
measure: AUC480 (the area under the curve of serum concentration of misoprostol acid against time up to 480 minutes)
timeFrame: 480 min post start of oral misoprostol administration
Secondary outcomes:
measure: AUC240 (the area under the curve of serum concentration of misoprostol acid against time up to 240 minutes)
timeFrame: 240 min post start of oral misoprostol administration
measure: AUC360 (the area under the curve of serum concentration of misoprostol acid against time up to 360 minutes)
timeFrame: 360 min post start of oral misoprostol administration
Other outcomes:
Locations:
city: Yunlin Xian
country: Taiwan
facility: China Medical University Beigang Hospital
Study officials:
affiliation: China Medical University Beigang Hospital
name: Shi-Yann Cheng, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tang OS, Schweer H, Seyberth HW, Lee SW, Ho PC. Pharmacokinetics of different routes of administration of misoprostol. Hum Reprod. 2002 Feb;17(2):332-6. doi: 10.1093/humrep/17.2.332.
citation: Zieman M, Fong SK, Benowitz NL, Banskter D, Darney PD. Absorption kinetics of misoprostol with oral or vaginal administration. Obstet Gynecol. 1997 Jul;90(1):88-92. doi: 10.1016/S0029-7844(97)00111-7.
Clinical trial NCT05496257: Calcium Hydroxide Versus Premixed Bioceramic Putty in Direct Pulp Capping of Primary Molars
Official title: Calcium Hydroxide Versus Premixed Bioceramic Putty in Direct Pulp Capping of Primary Molars: An Equivalent Parallel Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Direct Pulp Capping
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2022-08-11
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial will be conducted to evaluate and compare calcium hydroxide and premixed bioceramic putty regarding the clinical and radiographic outcomes of direct pulp capping in primary molars.

Detailed description: The current equivalent parallel randomized controlled trial will be conducted to evaluate and compare calcium hydroxide and premixed bioceramic putty regarding the clinical and radiographic outcomes of direct pulp capping in primary molars over a 24-month follow-up period.

Eligibility criteria: Inclusion Criteria:

* 1. Clinical:

  1. Children categorized as class I or II according to American Society of Anaesthesiologists (ASA) scale.
  2. Children rated as no. 3 or 4 in Frankl behaviour rating scale (FBRS).
  3. Presence of a small carious or traumatic pulp exposure (1 mm or less). 2. Radiographic:

  <!-- -->

  1. Presence of at least two-thirds of root length.
  2. Normal lamina dura and periodontal ligament space.

Exclusion Criteria:

* 1. Clinical:

  1. History of spontaneous unprovoked toothache.
  2. Extensive crown destruction that preclude coronal restoration.
  3. Gingival swelling, sinus tract or other soft tissue pathology.
  4. Abnormal tooth mobility.
  5. A frank pulp exposure (i.e., greater than 1.0mm), requiring pulpotomy.
  6. No evidence of visible pulp exposure.

     2. Radiographic:

  <!-- -->

  1. Furcation/periapical radiolucency.
  2. Pathological internal/external root resorption.
  3. Absence of underlying permanent successor

Primary outcomes:
measure: Clinical findings
timeFrame: 2 year follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia university
Study officials:
References: