louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02266901: Transluminal or Percutaneous Endoscopic Drainage and Debridement of Abcesses After Bariatric Surgery
Official title: Transluminal or Percutaneous Endoscopic Drainage and Debridement of Abcesses After Bariatric Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Sepsis
Keywords: leaks after bariatric surgery
fistulae after bariatric surgery
abdominal abcesses and bariatric surgery
endoscopic drainage of abcesses
percutaneous drainage of abcesses
gastric bypass
sleeve gastrectomy
necrotic collection and bariatric surgery
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2014-10-17
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patient treated in an academic tertiary center (Erasme Hospital) who underwent endoscopic drainage and debridement of abdominal abscesses secondary to postbariatric surgery leaks from october 2007 to April 2011. All other necrosectomies performed for pancreatic disorders were excluded from the study

Brief summary: Patients presenting intra-abdominal abcesses following bariatric surgery complicated by fistulae are classically treated by external drainage and endoprosthesis or surgical redo. Morbidity and mortality being increased in case of necrotic collections, an endoscopic debridement treatment might be proposed in certain cases. This present study aim to review the evolution of the patients treated by this method from 2007 to 2011 in the investigators institution.

Detailed description: This retrospective study in an academic tertiary center will review the files of patients who underwent endoscopic drainage and debridement of abdominal abscesses secondary to bariatric surgery leaks . The decision for endoscopic treatment was made by the medico-surgical team in charge of this type of surgery, who had to weigh the high risk of mortality in case of re-intervention, along with endoscopic access to abscesses via the transluminal or percutaneous route based on abdominal imaging.

Data collection will lead to the evaluation of the technical success rate, the clinical success and potential complications.

Eligibility criteria: Inclusion Criteria:

* All the patient treated in an academic tertiary center who underwent endoscopic drainage and debridement of abdominal abscesses secondary to bariatric surgery leaks from october 2007 to April 2011
* septic state

Exclusion Criteria:

* All other necrosectomies performed for pancreatic disorders were excluded from the study

Primary outcomes:
measure: Intervention technical success
timeFrame: during the procedure
Secondary outcomes:
measure: Clinical success
timeFrame: 7 days
Other outcomes:
Locations:
Study officials:
affiliation: Erasme Hospital, ULB
name: Jacques Devière, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00002401: A Study of Delavirdine Used Together With Other Anti-HIV Drugs in HIV-Infected Patients
Official title: An Open-Label Randomized Study of Delavirdine Mesylate (DLV, Rescriptor) in Triple and Quadruple Combinations With Zidovudine (ZDV), Indinavir (IDV), and Lamivudine (3TC) in HIV-1 Infected Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: HIV-1
Zidovudine
HIV Protease Inhibitors
Lamivudine
Indinavir
RNA, Viral
Delavirdine
Reverse Transcriptase Inhibitors
Viral Load
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 160
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if it is safe and effective to give delavirdine (DLV) in combination with two or three other drugs to HIV-infected patients. The drugs to be used in combination with DLV are zidovudine (ZDV), indinavir (IDV), and lamivudine (3TC).

Detailed description: In this open-label pilot study, patients are randomized to 1of the following 4 arms for 24 weeks:

Arm 1 (40 patients): DLV plus ZDV plus IDV. Arm 2 (40 patients): DLV plus IDV plus 3TC\*. Arm 3 (40 patients): DLV plus ZDV plus IDV plus 3TC. Arm 4 (40 patients): ZDV plus IDV plus 3TC.

* Dose determined by body weight. Patients may opt to continue on study for 24 additional weeks at the discretion of the investigator.

Eligibility criteria: Inclusion Criteria

Prior Medication:

Allowed:

Less than 1 month prior treatment with zidovudine.

Exclusion Criteria

Prior Medication:

Excluded:

* Prior indinavir.
* Prior lamivudine.
* Prior protease inhibitors.
* Prior non-nucleoside reverse transcriptase inhibitors.
* 1 month or more prior zidovudine.

  1. HIV-1 positive.
* CD4 coun tis above 50.
* HIV-1 RNA levels greater than 20,000.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Peapack
country: United States
facility: Pharmacia & Upjohn
state: New Jersey
Study officials:
References:
Clinical trial NCT06350201: Machine Learning-based Classification of Symptom Clusters and Online CBT
Official title: Machine Learning-based Classification of Symptom Clusters and Matched Online Cognitive Behavior Intervention for Depression Symptom and Anxiety Symptom
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression and Anxiety Symptom
Keywords: machine learning approach
CBT
Lead sponsor: Wuhan Mental Health Centre
Sponsor class: OTHER
First posted: 2024-04-05
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To breakthrough the bottleneck identified, we will conduct a cross-sectional study to develop a symptom clustering model for depression and anxiety. A wide range of statistical methods as well as machine learning approaches were explored, and a cohesive hierarchical clustering algorithm will be used. After developing the model, a symptom-matched intervention program based on problem solving therapy will be formulated. We are supposed to examine whether its use for personalizing symptom-matched psychological treatment can lead to improved patient outcomes, compared with usual care. This project is expected to provide a new and precise method for the emotion management, which will provide a standardized intervention pathway combining screening with treatment for the management of depression symptom and anxiety symptom. A preciser intervention matched to individual symptoms may provide important insight in improving patient outcome as well as a standardized mood management pathway targeting to the early detection and intervention for community residents.


Eligibility criteria: Inclusion Criteria:

* Meets the criteria of PHQ-9 and or GAD-7 ≥5 at baseline measurements

Exclusion Criteria:

* Patients who report the presence of suicidal thoughts in entry 9 of the PHQ-9 on any psychometric measurements, referred to the Wuhan Psychological Hotline Platform; and
* Those who are currently suffering from mental illness or are being treated with antipsychotic drugs;
* Women during pregnancy or within 3 months after delivery.

Primary outcomes:
measure: The Patient Health Questionnaire (PHQ-9)
timeFrame: 0 4week 8 week 6-month follow-up 12-month follow-up
Secondary outcomes:
measure: 7-tiem Generalized Anxiety Disorder Scale,GAD-.7
timeFrame: 0 4week 8 week 6-month follow-up 12-month follow-up
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01529801: Assessment of the Effect of a Novel Surface Roughness Treatment on Dental Implants on Integration Success
Official title: A Prospective Randomized-controlled Study of the Effect of Surface Topographies on Implant Integration Rates and Clinical Success
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Partial Edentulism
Tooth Disease
Keywords: edentulism
dental implants
clinical study
randomized
Osseotite Certain Tapered
Crestal bone level
Lead sponsor: ZimVie
Sponsor class: INDUSTRY
First posted: 2012-02-09
Enrollment: 80
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: A study where dental implants with different roughened surfaces will be evaluated for the ability to resist countertorque forces.

Detailed description: This study on dental implants with different roughened surfaces will assess its ability to resist countertorque testing at various study time points and demonstrate high success

Eligibility criteria: Inclusion Criteria:

* patients of either sex and older than 18 years of age
* patients needing at least one dental implant to treat partial edentulism
* patients physically able to tolerate surgical and restorative dental procedures
* patients agreeing to all protocol visits

Exclusion Criteria:

* patients with infection or severe inflammation at the intended treatment sites
* patients smoking greater than 10 cigarettes per day
* patients with uncontrolled diabetes mellitus
* patients with uncontrolled metabolic diseases
* patients who received radiation treatment to the head in the past 12 months
* patients needing bone grafting at the intended treatment sites
* patients known to be pregnant at screening visit
* patients with para-functional habits like bruxing and clenching

Primary outcomes:
measure: Primary stability countertorque measures
timeFrame: 6 weeks
Secondary outcomes:
measure: Cumulative success rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Hospital San Jose
Study officials:
affiliation: Hospital San Jose
name: Jaime Acuna, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02636101: Xamiol®Gel in BODY Psoriasis: A One-year Non-interventional Study
Official title: Xamiol® Gel in BODY Psoriasis : lonG-term Management of Psoriasis vUlgARis With Xamiol® Gel in Daily Clinical Practice of Russian Dermatologists. A Long-term Observational, Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psoriasis Vulgaris
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2015-12-21
Enrollment: 603
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with body psoriasis who (at their physician's discretion) are eligible to receive topical treatment with calcipotriol/betamethasone gel

Brief summary: This study aims to describe the patient population treated and the real-life patients' experiences with Xamiol®gel in the long term, up to 52 weeks management of body psoriasis vulgaris in Russia. The result will increase the knowledge on Xamiol®gel enabling dermatologists and patients to optimize its use in the long term management of psoriasis.


Eligibility criteria: Inclusion Criteria:

* Psoriasis vulgaris on body
* Patients planned to receive topical treatment on the body with calcipotriol/betamethasone gel
* Written informed consent

Exclusion Criteria:

* No or very mild symptoms of psoriasis vulgaris on the body at study start
* Any on-going treatments at study start with topical steroids, salicylic acid or its combination
* Other topical treatment for body psoriasis
* Pregnancy or planned pregnancy within treatment period
* Contraindications according to prescribing information.

Primary outcomes:
measure: Patient reported treatment satisfaction
timeFrame: Around 8 weeks after treatment initiation
measure: Adherence to treatment
timeFrame: Around 8 weeks after treatment initiation
Secondary outcomes:
measure: Physician Global Assessment of Psoriasis
timeFrame: Around 8 weeks after treatment initiation
measure: Frequency of treatment after completion of initial treatment
timeFrame: 12 months
measure: To evaluate the effect of treatment with Xamiol®gel on patients quality of life
timeFrame: Around 8 weeks
measure: Overall rate of treatment success
timeFrame: Around 8 weeks
measure: Patient's willingness to pay
timeFrame: 12 months
Other outcomes:
Locations:
city: Saratov
country: Russian Federation
facility: Municipal out-patient clinic 7
Study officials:
affiliation: LEO Pharmaceutical Products LLC
name: Dmitry Petrunin, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Results of the long-term observational noninterventional prospective study BODYGUARD in psoriasis patients Bakulev, A. L. [2] , and Petrunin, D. D. [1] , Vestnik dermatologii i venerologii (volume 95, issue 4, pages 87-93) , 10/19/2019
citation: EADV 2019 Abstract P1788. Bakulev AL, Petrunin DD. Results from a long-term, observational, non-interventional, prospective study in patients with body psoriasis based on patient-reported outcomes and physician's assessments (BODYGUARD).
Clinical trial NCT04460001: Injection of Ranibizumab Versus Combination of Ranibizumab and Triamcinolone Acetate for (CRVO)
Official title: Intravitreal Injection of Ranibizumab Versus Combination of Ranibizumab and Triamcinolone Acetate for the Treatment of Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Ophthalmopathy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the clinical effectiveness of ranibizumab and combination of ranibizumab and triamcinolone for the treatment of macular oedema secondary to CRVO


Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older with visual impairment resulting from macular edema secondary to CRVO.
* A BCVA approximate Snellen equivalents, 20/40.

Exclusion Criteria:

* Use of intra-vitreal anti-VEGF injections 3 months or less before baseline.
* Pan-retinal laser photocoagulation 3 months or less before baseline,
* Topical ocular or systemic corticosteroids administered for 30 consecutive days.
* Intraocular or periocular corticosteroid use 3 months or less before screening (study eye),
* Use of intraocular corticosteroid implants,
* Uncontrolled glaucoma (intraocular pressure \[IOP\] 30 mmHg with medication) at the time of screening or baseline,
* iris neovascularization or neo-vascular glaucoma.

Primary outcomes:
measure: Comparison between intravitreal injection of ranibizumab and combination of ranibizumab and triamcinolone acetate for the treatment of macular edema secondary to CRVO
timeFrame: 2 year
measure: Comparison between intravitreal injection of ranibizumab and combination of ranibizumab and triamcinolone acetate for the treatment of macular edema secondary to CRVO
timeFrame: 2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Asyut
country: Egypt
facility: Wael
Study officials:
References:
Clinical trial NCT00008801: hOKT3gamma1 (Ala-Ala) for the Prevention of Human Islet Allograft Failure
Official title: hOKT3gamma1 (Ala-Ala) for the Prevention of Human Islet Allograft Failure
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Diabetes Mellitus, Insulin-Dependent
Diabetes Mellitus, Experimental
Transplantation, Homologous
Islets of Langerhans Transplantation
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2001-01-18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The broad, long-term goal of this proposal is to improve the results and applicability of islet allotransplantation early in the course of type 1 diabetes through the administration of selective and short-term immunotherapy. More specifically, the objectives of these studies is to conduct an open-labeled, one-year follow-up Phase I/II study in patients with surgical and type 1 diabetes to determine the safety, tolerability, immune activity, and pharmacokinetics of hOKT3gamma1 (Ala-ala) administration for the prevention of autoimmune destruction and rejection of allogeneic islet transplants.

Detailed description: Adverse events will be monitored and recorded throughout the first year post-transplant. The proportion of surgical and type 1 diabetic subjects receiving an islet allotransplant who achieve and maintain full or partial islet graft function during the first year post-transplant will be determined to assess the efficacy of hOKT3gamma1 (Ala-ala) administration. Successful completion of the proposed clinical trial will increase our understanding of the safety, efficacy and underlying mechanisms of selective immunotherapy with the anti-CD3 monoclonal antibody hOKT3gamma1 (Ala-ala) for the maximization of engraftment and functional survival of allogeneic human islets in surgical and type 1 diabetic recipients.

Eligibility criteria: Inclusion:

* Primary islet allotransplant
* surgical or type 1 diabetes mellitus, complicated by signs and symptoms that persist despite intensive efforts made in close cooperation with their diabetes care team
* Age 18 or older
* must give written informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT01459601: Cabergoline Effect on Blood Sugar in Type 2 Diabetics
Official title: Cabergoline Effects on Blood Sugar Control in Type 2 Diabetics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Type 2
Keywords: diabetes mellitus
FBS
HbA1C
Cabergoline
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-10-25
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Diabetic patients with poorly control blood sugar are prescribed cabergoline for 1 months and their blood glucose is evaluated.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* HbA1C\>7

Exclusion Criteria:

* HbA1C\>10
* Psychiatric disorders

Primary outcomes:
measure: FBS (fasting blood sugar)
timeFrame: 30days
Secondary outcomes:
measure: HbA1C
timeFrame: 30days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03153501: Efficiency and Safety of Pleural Biopsy Methods in the Diagnosis of Pleural Diseases
Official title: How Should be Invasive Diagnostic Algorithm in Pleural Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diagnosis of Pleural Diseases
Medical Thoracoscopy
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2017-05-15
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Image-guided pleural biopsies, both ultrasound (US) or computed tomography (CT) guided, and medical thoracoscopy are important in the diagnosis of pleural disease. However, no consensus exists regarding which biopsy methods are appropriate for specific procedures.

In this prospective study, the investigators aimed to compare CT-scan guided pleural biopsy using an Abrams' needle (CT-ANPB) with US-assisted pleural biopsy using a cutting needle (US-CNPB)and medical thoracoscopy with respect to both diagnostic yield and safety.

Detailed description: The primary end point of this study was the determination of the sensitivity and the complication rates of the invasive methods, Abrams needle pleural biopsy, tru-cut needle pleural biopsy, medical thoracoscopy with respect to the diagnosis of pleural disease.

Eligibility criteria: Inclusion Criteria:

* Patients with pleural diseases

Exclusion Criteria:

* Patients with other lung diseases

Primary outcomes:
measure: Diagnostic efficiencies of pleural biopsy methods; CT-guided Abrams needle, US-guided cutting needle and medical thoracoscopy in the diagnosis of pleural diseases: The sensitivity, specificity, negative predictive value and positive predictive value.
timeFrame: 5 years
measure: Safety of pleural biopsy methods; CT-guided Abrams needle, US-guided cutting needle and medical thoracoscopy in the diagnosis of pleural diseases: Rate of side effects.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Eskisehir
country: Turkey
facility: ESOGU Medical Faculty Department of Chest Diseases
state: Meselik - Eskisehir
city: Eskişehir
country: Turkey
facility: Eskisehir Osmangazi University Medical Faculty
Study officials:
affiliation: ESOGU Medical Faculty
name: Muzaffer Metintas, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim SJ, Choi SM, Lee J, Lee CH, Lee SM, Yim JJ, Yoo CG, Kim YW, Han SK, Park YS. Medical Thoracoscopy in Pleural Disease: Experience from a One-Center Study. Tuberc Respir Dis (Seoul). 2017 Apr;80(2):194-200. doi: 10.4046/trd.2017.80.2.194. Epub 2017 Mar 31.
Clinical trial NCT04548401: Effect of Antiplatelet Therapy on Cognition After Aneurysmal Subarachnoid Hemorrhage
Official title: Effect of Antiplatelet Therapy on Cognition After Aneurysmal Subarachnoid Hemorrhage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aneurysmal Subarachnoid Hemorrhage
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with aSAH who received endovascular treatment.

Brief summary: Deficits in memory, executive function, and language are common cognitive sequelae of aneurysmal subarachnoid hemorrhage (aSAH). Previous study demonstrated that post-treatment antiplatelet therapy reduced risk for delayed cerebral ischemia caused by aSAH. However, the effect of antiplatelet therapy on cognition after aSAH is unclear. The aim of this study was to assess the effect of antiplatelet therapy on cognition after aSAH.


Eligibility criteria: Inclusion Criteria:

* 1. Patients with SAH in whom the aneurysm was proven by conventional angiography; 2. Baseline Hunt-Hess grade I-III; 3. patients received endovascular treatment

Exclusion Criteria:

* 1. Hunt-Hess grade IV-V; 2. Non-aneurysmal SAH; 3. Dementia in other diseases; 4. Lacking of 6-8 month MoCA evaluation.

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA) Test
timeFrame: 6-8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Hai Bin Shi, MD
role: PRINCIPAL_INVESTIGATOR
References: