louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04987515: Clinical Evaluation of Fenestration Decompression Combined With Secondary Curettage for Ameloblastoma of the Jaw: Retrospective Radiographic Analysis
Official title: Clinical Evaluation of Fenestration Decompression Combined With Secondary Curettage for Ameloblastoma of the Jaw: Retrospective Radiographic Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Cavity Area Reduction Efficiency
the Recurrence of the Tumor
Lead sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 233
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical records of patients diagnosed as multicystic ameloblastoma (MA) or unicystic ameloblastoma (UA) by routine pathology were collected from January 2010 to December 2017 in Ninth People's Hospital, Shanghai JiaoTong University Medical College. Patients were divided into two groups based on the management regimen: fenestration decompression combined with secondary curettage (FDSC) group, and local curettage (LC) group. Patients were followed up for 3-8 years, using panoramic radiography to measure the change of the area of the cystic cavity involved in ameloblastoma and the recurrence or malignant transformation of the tumor in both groups.

Brief summary: Objectives: To investigate the outcomes of fenestration decompression combined with secondary curettage (FDSC) in the surgical treatment of jaw ameloblastoma.

Methods: Medical records of patients diagnosed as multicystic ameloblastoma (MA) or unicystic ameloblastoma (UA) by routine pathology were collected from January 2010 to December 2017 in Ninth People's Hospital, Shanghai JiaoTong University Medical College. Patients were divided into two groups based on the management regimen: FDSC group, and local curettage (LC) group. Patients were followed up for 3-8 years, using panoramic radiography to measure the change of the area of the cystic cavity involved in ameloblastoma and the recurrence or malignant transformation of the tumor in both groups. A total of 233 eligible patients were selected for provisional screening, including 145 patients with MA, and 88 patients with UA.


Eligibility criteria: Inclusion Criteria:

-Medical records of patients who were diagnosed with multicystic ameloblastoma (MA) or unicystic ameloblastoma (UA) by routine pathology were collected from January 2010 to December 2017 in Ninth People's Hospital of Shanghai JiaoTong University Medical College.

Exclusion Criteria:

* followed up less than 3 years
* For FDSC group, fenestration decompression failed
* recurrent ameloblastoma
* received other type of surgery;

Primary outcomes:
measure: Cystic cavity area reduction efficiency
timeFrame: 3 years after surgery
Secondary outcomes:
measure: Tumor recurrence rate
timeFrame: 3 years after surgery
Other outcomes:
measure: malignant transformation rate
timeFrame: 3 years after surgery
Locations:
Study officials:
References:
Clinical trial NCT02647515: Intravitreal Ranibizumab Injection as Adjuvant in the Treatment of Postvitrectomy Diabetic Vitreous Hemorrhage Accompanied by Neovascular Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetic Retinopathy
Glaucoma, Neovascular
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Ningbo University
First posted: 2016-01-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the efficacy of intravitreal ranibizumab injection as adjuvant therapy in the treatment of postvitrectomy diabetic vitreous hemorrhage (PDVH) accompanied by neovascular glaucoma (NVG) as a means of preventing recurrent vitreous hemorrhage （VH） and optimizing postoperative intraocular pressure（IOP）control.


Eligibility criteria: Inclusion Criteria:

* age≥18 years
* PDVH obscuring the disc and vessels for more than 14 days and no evidence of retinal detachment after primary vitrectomy for PDR-related complications such as nonclearing VH, macula-involving or macula-threatening tractional retinal detachment, or fibrovascular proliferation with vitreoretinal adhesions
* NVG occurred following PDVH less than 4 weeks (NVG was diagnosed when an IOP elevation of 22mmHg or more was accompanied by neovascularization of the iris and/or the anterior chamber angle)

Exclusion Criteria:

* intraoperative use of long-acting gas or silicone oil in primary vitrectomy, repeat vitrectomy after primary vitrectomy for retinal diseases other than VH, previous history of vitrectomy
* previous intravitreal injection of ranibizumab or bevacizumab in either eye
* previous intravitreal corticosteroids injection in either eye
* pregnancy or current oral contraceptive intake
* usage of clopidogrel bisulfate or coumadin
* uncontrolled hypertension and cardiac disease
* uncontrolled renal or liver disease

Primary outcomes:
measure: vitreous hemorrhage
timeFrame: 12 months
measure: intraocular pressure
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Schachat AP, Oyakawa RT, Michels RG, Rice TA. Complications of vitreous surgery for diabetic retinopathy. II. Postoperative complications. Ophthalmology. 1983 May;90(5):522-30. doi: 10.1016/s0161-6420(83)34540-1.
citation: Luke J, Nassar K, Luke M, Grisanti S. Ranibizumab as adjuvant in the treatment of rubeosis iridis and neovascular glaucoma--results from a prospective interventional case series. Graefes Arch Clin Exp Ophthalmol. 2013 Oct;251(10):2403-13. doi: 10.1007/s00417-013-2428-y. Epub 2013 Jul 28.
citation: Shen X, Chen Y, Wang Y, Yang L, Zhong Y. Intravitreal Ranibizumab Injection as an Adjuvant in the Treatment of Neovascular Glaucoma Accompanied by Vitreous Hemorrhage after Diabetic Vitrectomy. J Ophthalmol. 2016;2016:4108490. doi: 10.1155/2016/4108490. Epub 2016 May 16.
Clinical trial NCT06824415: Sleep TMS for Depression
Official title: Optimizing Depression Treatment Through Sleep-state Brain Stimulation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Major Depression
Sleep
Keywords: sleep
tms
eeg
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2025-02-13
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to establish the feasibility, tolerability, and preliminary efficacy of sleep-state transcranial magnetic stimulation (TMS) for enhancing plasticity in depression treatment.


Eligibility criteria: Inclusion Criteria:

* Current Major Depressive Disorder (MDD) diagnosis
* Failed \>= 1 antidepressant medication
* Moderate-to-severe depression

Exclusion Criteria:

* Intellectual disability
* Significant head injury/neurological disorder
* Pregnancy or postpartum
* TMS/MRI contraindications
* Active substance use/suicidal ideation

Primary outcomes:
measure: Change in Baseline TMS-EEG after iTBS
timeFrame: Baseline, end of iTBS (3 minutes)
measure: Change in Baseline TMS-EEG after NREM Sleep
timeFrame: Baseline, end of sleep stage (3 hours)
measure: Change in N-back Accuracy Performance
timeFrame: Baseline, end of sleep stage (3 hours)
measure: Change in N-back Reaction Time Performance
timeFrame: Baseline, end of sleep stage (3 hours)
measure: Change in MSIT Accuracy Performance
timeFrame: Baseline, end of sleep stage (3 hours)
measure: Change in MSIT Reaction Time Performance
timeFrame: Baseline, end of sleep stage (3 hours)
Secondary outcomes:
measure: Changes in Pittsburgh Sleep Quality Index (PSQI) Scores
timeFrame: After each sleep session (3 hours)
measure: Changes in Treatment Tolerability
timeFrame: After each sleep session (3 hours)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Corey J Keller, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00967915: Efficacy of Neonatal Release of Ankyloglossia
Official title: Efficacy of Neonatal Release of Ankyloglossia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankyloglossia
Keywords: Ankyloglossia
Tongue tie
Frenotomy
Frenulectomy
Breast feeding
HATLFF
IBFAT
Lead sponsor: United States Naval Medical Center, Portsmouth
Sponsor class: FED
First posted: 2009-08-28
Enrollment: 58
Sex: ALL
Minimum age (years): 0
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if frenotomy for ankyloglossia will improve infant breastfeeding, decrease maternal nipple pain and increase duration of breastfeeding with the hypothesis that frenotomy will do all of the above.

Detailed description: The primary objective of our study is to determine if frenotomy (or release of tongue tie) for ankyloglossia (tongue tie) will decrease maternal nipple pain with breast feeding and improve infant's ability to breast feed. Our secondary objective is to determine if frenotomy for ankyloglossia will improve the length of time a mother breast feeds. Our hypothesis is that frenotomy will decrease maternal nipple pain, improve infant's breast feeding and prolong the duration of breast feeding.

Eligibility criteria: Inclusion Criteria:

* Significant ankyloglossia as judged by Hazelbaker scale (HATLFF)
* Report of maternal nipple pain with feeding
* Report of difficulty with infant breast feeding

Exclusion Criteria:

* Significant craniofacial defects
* Age \>14 days at enrollment
* Any maternal contraindication to breastfeeding
* Neurologic defects that would impair breast feeding

Primary outcomes:
measure: Maternal nipple pain as judged by R. Melzack's short form pain scale and infant breast feeding as judged by IBFAT scale
timeFrame: immediately following 1st breast feed, and at 2 week, 2,4,6 12 month follow ups
Secondary outcomes:
measure: Length of breast feeding
timeFrame: 1 year follow up
Other outcomes:
Locations:
city: Portsmouth
country: United States
facility: Naval Medical Center Portsmouth
state: Virginia
Study officials:
References:
citation: Buryk M, Bloom D, Shope T. Efficacy of neonatal release of ankyloglossia: a randomized trial. Pediatrics. 2011 Aug;128(2):280-8. doi: 10.1542/peds.2011-0077. Epub 2011 Jul 18.
Clinical trial NCT00555815: Intraoperative Hygiene Measures and Surgical Site Infections
Official title: Intraoperative Hygiene Measures and Rates of Surgical Wound Infection in General Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Surgical Site Infection
Hygiene
Discipline
Colorectal Surgery
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2007-11-09
Enrollment: 1032
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients undergoing general surgery in university hospital

Brief summary: Surgical site infections are associated with high morbidity and cost Hypothesis: Extended intraoperative hygiene measures decrease surgical site infections in general surgery compared to standard hygiene measures.

Detailed description: Intraoperatively two types of hygiene measures were performed randomly: standard and extensive. Standard hygiene measures included empiric accepted measures (e.g. gloves, masks, disinfection). Extensive hygiene measures included among others: double gloving, astro caps, extensive disinfection, extensive intraoperative rinsing. In addition, intraoperative adherence to the rules of asepsis were registered by an independent observer.

Patients were followed for 30 days.

Eligibility criteria: Inclusion Criteria:

* Patient undergoing surgical operation in one of two assigned operative theaters. Only initial operations are studied

Exclusion Criteria:

* Previous inclusion into study

Primary outcomes:
measure: Surgical site infection 30 days postoperative
timeFrame: 30 days
Secondary outcomes:
measure: Adherence to rules of asepsis by members of the surgical team
timeFrame: intraoperative
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Visceral and Transplant Surgery, University hospital, Inselspital
Study officials:
affiliation: Department of Visceral and Transplant Surgery
name: Daniel Candinas, MD
role: STUDY_DIRECTOR
References:
citation: Beldi G, Bisch-Knaden S, Banz V, Muhlemann K, Candinas D. Impact of intraoperative behavior on surgical site infections. Am J Surg. 2009 Aug;198(2):157-62. doi: 10.1016/j.amjsurg.2008.09.023. Epub 2009 Mar 12.
Clinical trial NCT02559115: 68Ga-RM2 for PET/CT of Gastrin Releasing Peptide Receptor (GRPr) Expression in Prostate Cancer
Official title: A Phase II Study of 68Ga-RM2 for PET/CT of Gastrin Releasing Peptide Receptor (GRPr) Expression in Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: 68Ga-RM2
PET/CT scan
Gastrin Releasing Peptide Receptor (GRPr)
14-146
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2015-09-24
Enrollment: 19
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to see if a new diagnostic research agent named 68Ga-RM2 can show prostate cancer on a PET/CT scan. 68Ga-RM2 stands for Galium-68 labeled DOTA-4-amino-1-carboxymethylpiperidine-D-Phe-Gln-Trp-Ala-Val-Gly-His-Sta-Leu-NH2. This study is being done because there are unmet medical needs to improve the current ways of detecting prostate cancers before surgery.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Biopsy proven adenocarcinoma of the prostate
* Patients with low-risk, intermediate-risk and high-risk tumors according to NCCN guidelines (2.2014) will be included
* Planned radical prostatectomy at MSKCC
* Multiparametric MRI of the pelvis (performed or planned) as routine care

Exclusion Criteria:

* Patients meeting any of the following exclusion criteria will not be eligible for study entry:
* Hematologic

  * Platelets \<75K/mcL
  * ANC \<1.0 K/mcL
* Hepatic laboratory values

  * Bilirubin \>2.0 x ULN (institutional upper limits of normal)
  * AST/ALT \>2.5 x ULN
* Renal laboratory values

  o Creatinine \> 2.0 x ULN
* Claustrophobia interfering with MRI and PET/CT imaging
* Prior pelvic radiation
* Prior androgen deprivation therapy
* Patients deemed not surgical candidates due to prohibitive co-morbidities

Primary outcomes:
measure: Localizing Tumors
timeFrame: within two weeks prior to the planned prostatectomy
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Herbert Vargas Alvarez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01398215: Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Transvaginal Ventral Hernia Repair
Official title: Natural Orifice Translumenal Endoscopic Surgery (NOTES): Laparoscopic Assisted Transvaginal Ventral Hernia Repair
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Umbilical Hernia
Ventral Hernia
Keywords: umbilical hernia
ventral hernia
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2011-07-20
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who come to the UC San Diego Surgical Specialties clinic and have chosen to undergo a ventral hernia repair will be evaluated for participation in this tria

Brief summary: This is a prospective chart review/data collection study of natural orifice translumenal endoscopic surgery (NOTES) for ventral hernia repair, that will include questionnaires administered throughout the study. Subjects enrolled will be those intending to have a transvaginal NOTES ventral hernia repair. Data will be collected and reviewed through 12 months post-op.


Eligibility criteria: Inclusion:

1. Umbilical or incisional hernia greater than 2 cm in size
2. Female, age 18-75
3. Mentally competent to give informed consent
4. Scheduled to undergo a transvaginal NOTES ventral hernia repair

Exclusion:

1. Pregnant women
2. Patients with defects measuring greater than 10 cm in size
3. Patients with complex hernias requiring fascial mobilization for closure
4. Morbidly obese patients (BMI \>45)

Primary outcomes:
measure: To assess outcomes related to the transvaginal NOTES approach to laparoscopic ventral hernia repair (through data collection).
timeFrame: 1 Year
measure: To assess pain associated with the transvaginal NOTES approach to laparoscopic ventral hernia repair (through data collection).
timeFrame: 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego Medical Center
state: California
Study officials:
affiliation: UCSD
name: Garth Jacobsen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00219115: A Clinical Study to Compare Combination of Aliskiren+ HCTZ to Irbesartan+ HCTZ or Amlodipine+ HCTZ or HCTZ Alone in Obese Hypertensive Not Responsive to HCTZ 25 mg
Official title: A 12-week Randomized Double-blind Parallel Group Study to Evaluate the Efficacy and Safety of the Combination Aliskiren With HCTZ Compared to Irbesartan or Amlodipine With HCTZ or HCTZ Alone in Hypertensive Patients With BMI ≥ 30 kg/m2 Not Adequately Responsive to HCTZ 25 mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension, aliskiren, blood pressure, irbesartan, amlodipine, hydrochlorothiazide
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 493
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: To evaluate the blood pressure lowering effects of the combination of aliskiren 300 mg and HCTZ 25 mg in obese patients with essential hypertension inadequately treated with HCTZ 25 mg, compared to irbesartan or amlodipine with HCTZ or HCTZ alone.


Eligibility criteria: Inclusion Criteria

* Patients with essential hypertension
* Patients with body mass index ≥ 30 kg/m2

Exclusion Criteria

* Severe hypertension
* History or evidence of a secondary form of hypertension
* History of Hypertensive encephalopathy or cerebrovascular accident.

Other protocol-defined inclusion exclusion criteria also apply.

Primary outcomes:
measure: Change from baseline in mean sitting diastolic blood pressure after 8 weeks
Secondary outcomes:
measure: Change from baseline in mean sitting systolic blood pressure after 8 weeks
measure: Evaluate number mean sitting systolic/diastolic response from baseline to weeks 4 and 8
measure: Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after week 8
measure: Achieve mean sitting blood pressure control target of < 140/90 mmHg after week 8
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
city: Investigative Centers
country: Germany
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Jordan J, Engeli S, Boye SW, Le Breton S, Keefe DL. Direct Renin inhibition with aliskiren in obese patients with arterial hypertension. Hypertension. 2007 May;49(5):1047-55. doi: 10.1161/HYPERTENSIONAHA.106.084301. Epub 2007 Mar 12.
Clinical trial NCT05198115: Premenstrual Syndrome in Young Women With Eight Weeks of Aerobic Exercise
Official title: Premenstrual Syndrome in Young Women With Eight Weeks of Aerobic Exercise
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Aerobic Exercise
Premenstrual Syndrome
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eight Weeks of Aerobic Exercise
Primary purpose: OTHER

Brief summary: The premenstrual syndrome includes physical and psychological symptoms that occur at the end menstrual cycle and exercise is one of the ways to reduce symptoms. The aim of this study was to determine the effect of a regular 8-week aerobic exercise program on psychological symptoms of premenstrual syndrome.

Detailed description: Premenstrual syndrome is characterized by the presence of both physical and behavioral (including affective) symptoms that occur repetitively in the second half of the menstrual cycle and interfere with some aspects of the woman's life(1). The core symptoms of PMS include affective symptoms, such as irritability, depression, anxiety, and somatic symptoms, such as breast pain, bloating, swelling, and headache (2). Women with moderate to severe PMS symptoms had a reduction in health-related quality of life(3) and work productivity, increased work absenteeism, and visits to ambulatory healthcare providers (4), so the treatment of this syndrome is essential.

Eligibility criteria: Inclusion Criteria:

* young women aged 18-25 years with a body mass index (BMI): 18-25 kg/m2, having regular menstrual cycles of 23-35 days duration, no previous practice of aerobic exercise, free from musculoskeletal injury, not using oral contraceptive pills or taking any psychotropic agents, having no depression or genital tract diseases

Exclusion Criteria:

* pregnancy, contraindications to physical exercise, metabolic or cardiorespiratory illness, cigarette smokers, women who recover from a major injury or using anti-inflammatory, hyperlipidemia or hypertension medications, any abnormality in ovulation, and women with diabetes mellitus, thyroid, pituitary, or ovarian disorders

Primary outcomes:
measure: Emotional (EM) scale
timeFrame: eight weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: