louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04297787: Safety and Efficacy of Thrombolysis in Combination With Endhole Aspiration in the Treatment of Acute DVT
Official title: Safety and Efficacy of Thrombolysis in Combination With Endhole Aspiration in the Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Deep Vein Thrombosis
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: Penumbra Inc.
First posted: 2020-03-05
Enrollment: 3
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: The purpose of this study is to demonstrate the safety and efficacy of thrombolysis in combination with endhole aspiration in the treatment of acute deep vein thrombosis (DVT). Secondarily, the study team hope to illuminate the financial implications of single session catheter directed therapy versus a potential 48 hour lysis procedure (Lysis is an approach in which vascular specialists deliver clot-dissolving drugs directly to the site of the clot through a catheter).


Eligibility criteria: Inclusion Criteria:

* Over 18 years of age
* Onset of acute DVT occurred \<14 days
* Ability to undergo thrombolysis in combination with Indigo endhole aspiration device

Exclusion Criteria:

* Under 18 years of age
* Presence of subacute (14-28 days) or chronic DVT (\>28 days)
* Contraindication to mechanical thrombectomy

Primary outcomes:
measure: Post-thrombotic Syndrome (PTS) severity using the Villalta score
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: Interventional Radiology-Vascular
name: Aaron Rohr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05121987: Analgesic and Respiratory Outcomes in Patients Receiving Continuous Bilateral Erector Spinae Plane Block Compared to Continuous Preperitoneal Catheter Wound Infusion After Upper Abdominal Surgery
Official title: Analgesic and Respiratory Outcomes in Patients Receiving Continuous Bilateral Erector Spinae Plane Block Compared to Continuous Preperitoneal Catheter Wound Infusion After Upper Abdominal Surgery: a Randomized Double-blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominal Cancer Surgery
Lead sponsor: South Egypt Cancer Institute
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 60
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: PREVENTION

Brief summary: We aim to compare the postoperative analgesic and respiratory outcomes in patients receiving continuous bupivacaine infusion via bilateral erector spinae catheters versus preperitoneal catheters in upper abdominal surgeries.


Eligibility criteria: Inclusion Criteria:

* ASA physical status I-II, weighing 50-90 Kg with Body Mass Index (BMI) 18.5- 29.9 kg/m2

Exclusion Criteria:

* ASA physical status ≥III, pregnancy, body mass index \>30 kg/m2, preoperative opioid consumption, patient's refusal and contraindications of the use of spirometry or either of the truncal blocks under the study including; respiratory, cardiac, neurological, mental or coagulation disorders.

Primary outcomes:
measure: Total Morphine consumption
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01094587: Sutureless vs Sutured Gastroschisis Closure
Official title: Sutureless vs Sutured Gastroschisis Closure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastroschisis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2010-03-29
Enrollment: 39
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to prospectively assess outcomes of sutureless versus sutured gastroschisis closure with a randomized control trial. The parameters of this trial were determined using our retrospective study as pilot data. Primary outcome measures will be time on ventilator and time to initiating enteral feeds. Other outcome measures will include cosmetic outcome, length of hospital stay and the associated rate of complications, including bowel resection, sepsis, and death.

Detailed description: This study aims to prospectively assess outcomes of sutureless versus sutured gastroschisis closure with a randomized control trial. The parameters of this trial were determined using our retrospective study as pilot data. Primary outcome measures will be time on ventilator and time to initiating enteral feeds. Other outcome measures will include cosmetic outcome, length of hospital stay and the associated rate of complications, including bowel resection, sepsis, and death.

In comparing these techniques of gastroschisis closure, we can further evaluate which is the safer and more efficacious method, thereby improving patient care while decreasing hospital cost.

Eligibility criteria: Inclusion Criteria:Inclusion criteria are the diagnosis of gastroschisis, birth weight of 1500 grams or greater, and gestational age of 34 weeks or more.

Exclusion Criteria:Exclusion criteria are infants with other major abnormalities or medical conditions, grade IV intraventricular hemorrhage, inability to obtain informed consent, and the presence of a closed-type gastroschisis defect.

Primary outcomes:
measure: Time on ventilator
timeFrame: Up to 1 week
measure: Time to initiating enteral feeds
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Cosmesis
timeFrame: 6 months after hospital discharge
measure: Length of hospital stay
timeFrame: Up to 6 weeks
measure: Complications including bowel resection, sepsis, and death.
timeFrame: Up to 45 days
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Sanjeev Dutta
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01474187: Genotype-driven Phase I Study of Irinotecan Administered in Neoadjuvant Chemoradiotherapy in Patients With Stage II/III Rectal Cancer
Official title: Genotype-driven Phase I Study of Irinotecan Administered in Neoadjuvant Chemoradiotherapy in Patients With Stage II/III Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Rectal Cancer
Keywords: Neoadjuvant chemotherapy
rectal cancer
phase I study
irinotecan
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2011-11-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Irinotecan is one of effective drugs for colorectal cancer. In neoadjuvant chemoradiotherapy (CRT), Irinotecan is prescribed in a low dose of 50mg/m2/week because of toxicity. Some current studies showed that irinotecan's dose can be increased significantly for those patients with 6/6 or 6/7 genotype of UGT1A1. therefore, the investigators designed this trial to explore the maximal tolerable dose (MTD) of Irinotecan in combined neoadjuvant CRT.


Eligibility criteria: Inclusion Criteria:

* Patients with rectal adenocarcinoma
* Clinical staged T3/4 or any node-positive disease
* Age of 18-75 years
* Karnofsky Performance Status \> 80
* Adequate bone marrow reserve, renal and hepatic functions
* Without previous antitumoural chemotherapy
* No evidence of metastatic disease
* Written informed consent before randomization
* UGT1A1's genotype of 6/6 or 6/7

Exclusion Criteria:

* Clinical staged I or IV
* Age of \<18 or \>75 years
* Karnofsky Performance Status \< 80
* Previous pelvis radiotherapy
* Previous antitumoural chemotherapy
* Clinically significant internal disease
* Refuse to write informed consent before randomization
* UGT1A1's genotype of 7/7

Primary outcomes:
measure: toxicity
timeFrame: 5 weeks
Secondary outcomes:
measure: pathological complete response (pCR)
timeFrame: within 14days after surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Cancer Hospital, Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT03351387: Wound Necrosis in Lower Extremity Surgery
Official title: Assessment of Wound Necrosis in Lower Extremity Surgery Using SPY Intra-operative Angiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Extremity Lower Wounds
Keywords: amputation
necrosis
high risk lower extremity wound
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: high risk lower extremity surgical candidates

Brief summary: Researchers are performing this study to evaluate if intraoperative angiography can be shown numerically to determine which wounds are at high risk of wound necrosis/breakdown.

Detailed description: At the beginning of the Participants surgical procedure, a picture will be obtained using intraoperative angiography using ICG dye which the camera can detect. This dye will be provided through intravenous access. The picture will be taken of the wound to determine preoperative blood flow to the area where the incision is planned. After the wound has been closed postoperatively, a final picture, using the procedure described above, will be taken to determine blood flow after closure of the wound. These images will be obtained using intraoperative angiography. The Participant will be followed after the surgical procedure at standard intervals as determined by the surgeon until the wound heals or requires further intervention.

Eligibility criteria: Inclusion Criteria:

-Surgical indication for high risk lower extremity surgery

Exclusion Criteria:

* Previous high risk lower extremity surgery
* Revision high risk lower extremity surgery
* Traumatic amputation
* Active infection of any kind or chronic infection with HIV, Hepatitis C, or Syphilis

Primary outcomes:
measure: Wound necrosis
timeFrame: 4 weeks after surgical intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Brandon Yuan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06782087: A Comparative Study Between the Efficacy of Diode Laser and Nano-chitosan Gel on Activation of Non-vital in- Office Bleaching Agent
Official title: A Comparative Study Between the Efficacy of Diode Laser and Nano-chitosan Gel on Activation of Non-vital in- Office Bleaching Agent :A Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE1
Conditions: Tooth Discoloration
Keywords: chitosan nanoparticles
Diode laser
carbamide peroxide
nonvital teeth bleaching
Lead sponsor: Misr University for Science and Technology
Sponsor class: OTHER
First posted: 2025-01-17
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The growing demand for white smile between patients has increased over recent years, the development of techniques and improvement of materials permits searching for beautiful natural smile.

The discoloration of teeth might be intrinsic, extrinsic, or combined. A variety of commercial bleaching agents is available. The most common substances used are carbamide peroxide or hydrogen peroxide or a mixture of sodium perborate and hydrogen peroxide.

Detailed description: The aim of the study is to assess the effectiveness of two different in-office bleaching materials carbamide peroxide alone and carbamide peroxide with Chitosan nanoparticles Using diode laser as an activator Regarding tooth whitening and color stability 1 Day , 1 weeks, 1 month after treatment using Vita easy shade.

Eligibility criteria: Inclusion Criteria:

* discolored crown, non-vital or endodontically treated upper central and lateral incisors
* previous endodontic treatment performed two or more years earlier.

Exclusion Criteria:

* caries on upper central and lateral incisors, inadequate fillings, and progressive periodontal disease.

Primary outcomes:
measure: Color change
timeFrame: these assessments were performed for 1 day, 1 week, and 1 month after treatment with Vita easy shade.
measure: color change using digital vita easy shade guide
timeFrame: 1 day , 1 week , 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Misr University for science and technology
Study officials:
affiliation: Lecturer in conservative surgery departement
name: Manal abd el baky A dr, phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT05389787: Impact of Cerebellar TMS on Brain and Cognitive Functions in Schizophrenia: a Pilot Study
Official title: Impact of Cerebellar TMS on Brain and Cognitive Functions in Schizophrenia: a Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Cerebellar Function
Condition
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This is a single-site, sham-controlled, randomized trial in a total of 60 subjects between ages 18 and 40 years with schizophrenia. This study will investigate the effects of 4-week rTMS treatment on brain and cognitive functions in patients. Subjects will be randomized to one of the following arms:

Arm 1: Standard of Care (SOC) and active rTMS Arm 2: Standard of Care (SOC) and sham rTMS

Each participant will receive rTMS five days per week, for four consecutive weeks. Functional magnetic resonance imaging (fMRI) scans, clinical assessments, and cognitive tests will be performed at baseline, end of the 2nd week, and end of the 4th week.


Eligibility criteria: Inclusion Criteria:

1. Male or female subjects 18 to 40 years of age
2. DSM-V diagnosis of schizophrenia spectrum disorders
3. Competent to provide informed consent

Exclusion Criteria:

1. Lifetime DSM-V diagnosis of an Axis-I disorder other than schizophrenia spectrum disorders
2. Lifetime diagnosis of ataxia or other cerebellar disorders
3. Lifetime diagnosis of mental retardation, dementia, Alzheimer's disease, Parkinson's disease, Huntington's disease, or other neurodegenerative disorders
4. Any active general medical condition or CNS disease which can affect cognition or response to treatment
5. Substance dependence or abuse in the past six months
6. Seizure history
7. TMS within three months or ECT within six months
8. Pregnancy as indicated by self-report
9. MRI contraindications

Primary outcomes:
measure: Cerebellar function
timeFrame: end of 2nd week and 4th week
Secondary outcomes:
measure: Cognitive function
timeFrame: end of 2nd week and 4th week
Other outcomes:
measure: Cerebellum-cognition associations
timeFrame: end of 2nd week and 4th week
Locations:
city: New York
country: United States
facility: Zucker Hillside Hospital
state: New York
Study officials:
References:
Clinical trial NCT02989987: NET for SGBV Survivors in Eastern DR Congo
Official title: Narrative Exposure Therapy for Survivors of Sexual and Gender Based Violence in Eastern DR Congo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Shame
Keywords: PTSD
Shame
Narrative Exposure Therapy
Sexual and gender based violence (SGBV)
DR Congo
Lead sponsor: University of Konstanz
Sponsor class: OTHER
Collaborators: name: Vivo international e.V.
First posted: 2016-12-12
Enrollment: 201
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Throughout the last 10 years Narrative Exposure Therapy (NET) has evolved as one of the most effective, culturally sensitive trauma interventions. In the present study the effectiveness of NET delivered by trained health personnel in a sample of survivors of sexual and gender based violence (SGBV) who suffer from Posttraumatic Stress Disorder (PTSD) will be assessed. Structured baseline, 3 and 6 month follow up interviews will be administered to assess the main outcome measures PTSD and shame. The trial will take place in Goma, DR Congo, where SGBV and its sequelae has been a major problem.

Detailed description: Participants will be recruited through local NGOs and eligible clients randomized to the treatment (NET; app. N=100) or treatment-as-usual control (app. N=100) group, respectively. At baseline, 3-month and 6-month post-treatment, sociodemographic data, trauma exposure - esp. SGBV, PTSD, dissociation, shame, functionality and depression will be assessed in a structured interview. The interviews will be conducted by blind Congolese psychological interviewers after an intensive 3-weeks training and continuous supervision.

Eligibility criteria: Inclusion Criteria:

* SGBV survivors (event happened more than 4 weeks ago)
* PTSD diagnosis (DSM-5)

Exclusion Criteria:

* Acute psychosis
* Signs of cerebro-organic disease
* Acute drug or alcohol intoxication

Primary outcomes:
measure: PSS-I: Posttraumatic Stress Disorder symptom severity (sumscore and diagnosis)
timeFrame: Change from baseline to 3 and 6 months post treatment
measure: SVQ: Severity of shame (sumscore)
timeFrame: Change from baseline to 3 and 6 months post treatment
Secondary outcomes:
measure: ShutD: Severity of Shutdown Dissociation Symptoms (sumscore)
timeFrame: Change from baseline to 3 and 6 months post treatment
measure: PHQ: Depression symptom severity (sumscore)
timeFrame: Change in 3 and 6 months post treatment
measure: Functionality (sumscore)
timeFrame: 3 and 6 months post treatment
Other outcomes:
Locations:
city: Konstanz
country: Germany
facility: University of Konstanz
state: BW
Study officials:
References:
citation: Schauer, M., Schauer, M., Neuner, F., & Elbert, T. (2011). Narrative exposure therapy: A short-term treatment for traumatic stress disorders. Hogrefe Publishing.
Clinical trial NCT03155087: PRKAA2 Genetic Polymorphisms and Its Susceptibility to Chinese Type 2 Diabetes Mellitus and Diabetic Nephropathy
Official title: The Influence of AMPK Subunit Alpha (PRKAA2) Genetic Polymorphisms With Susceptibility to Chinese Type 2 Diabetes Mellitus and Diabetic Nephropathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: T2DM (Type 2 Diabetes Mellitus)
Keywords: T2DM
genetic polymorphism
diabetic nephropathy
Lead sponsor: People's Hospital of Zhengzhou University
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the study recruited 500 T2DM patients and 250 healthy subjects who meet the enrollment cirterion from Zhengzhou Central Hospital during the period of July 2013 to December 2015 randomly.

Brief summary: Metformin is a classical oral antidiabetic drug, often recommended to be the first-choice treatment of type 2 diabetes mellitus (T2DM). Based on the previous research on PRKAA2, STK11 and diabetes, this study aimed to investigate the distributive characteristic of PRKAA2 and STK11 polymorphisms and the potential influence of STK11polymorphisms on metformin efficacy among Chinese T2DM patients, discuss the association of PRKAA2 polymorphisms between T2DM patients and healthy subjects.


Eligibility criteria: Inclusion Criteria:

* diagnosed with T2DM in keeping with the WHO criteria in 1999 \[14\], with fasting blood glucose (FBG) ≥ 7.0mmol ⁄ L and ⁄ or postprandial blood glucose (PBG) ≥ 11.1mmol ⁄ L; not using other antidiabetic drugs within the experimental period.

Exclusion Criteria:

* other significant illness such as cancer, myocardial infarction, stroke, severe liver, and kidney disease

Primary outcomes:
measure: the incidence of T2DM
timeFrame: Jan 2014-Dec 2015
Secondary outcomes:
measure: metformin efficacy----the decrease level of HbA1c
timeFrame: Jan 2014-Dec 2015
Other outcomes:
Locations:
Study officials:
References:
citation: Li Q, Li C, Li H, Zeng L, Kang Z, Mao Y, Tang X, Zheng P, He L, Luo F, Li Z. STK11 rs2075604 Polymorphism Is Associated with Metformin Efficacy in Chinese Type 2 Diabetes Mellitus. Int J Endocrinol. 2017;2017:3402808. doi: 10.1155/2017/3402808. Epub 2017 Jul 9.
Clinical trial NCT05429333: Effect of Microbiome Modulation by Diet in Functional Constipation
Official title: Effect of Artificial Intelligence-assisted Personalized Microbiome Modulation by Diet in Functional Constipation: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Constipation - Functional
Keywords: Microbiome
Artificial intelligence
Diet
Functional bowel disorders
Brain-gut diseases
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2022-06-23
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Current medications and behavioral modifications have limited success in the treatment of functional constipation (FC). An individualized diet based on microbiome analysis may improve symptoms in FC. In the present study, we aimed to investigate the impacts of microbiome modulation on chronic constipation. patients fulfilling Rome IV criteria for functional constipation were randomized into two groups. The Control group received sodium picosulfate plus conventional treatments (i.e., laxatives, enemas, increased fiber, and fluid intake). The study group underwent microbiome analysis and received an individualized diet with the assistance of a soft computing system (Enbiosis Biotechnology®, Sariyer, Istanbul). Differences in Patient Assessment Constipation-Quality of Life (PAC-QoL) score and complete bowel movements per week (CBMpW) were compared between groups after 6 week-intervention.


Eligibility criteria: Inclusion Criteria:

* Patients fulfilling Rome IV criteria for functional constipation (FC)
* Patients who had a colonoscopy performed within the last 5 years
* Patients who had a colonic transit time assessment within the last 3 months
* Patients who had a magnetic resonance defecography within the last 3 months

Exclusion Criteria:

* Use of antibiotics, probiotics, and/or prebiotics within the last 4 weeks
* Gastrointestinal endoscopy within the last 4 weeks
* Major gastrointestinal surgery (total/segmental gastrectomy, small bowel and/or colonic resection)
* Cholecystectomy
* Inflammatory bowel diseases
* Celiac disease
* Any etiology of chronic constipation other than FC (irritable bowel syndrome, rectocele, dyssynergic defecation, opioid use)
* Endocrine, metabolic or neurologic disorders causing constipation (hypothyroidism, Parkinson's disease, paraplegia)

Primary outcomes:
measure: Three or more complete bowel movements per week at 10 weeks
timeFrame: 10 weeks
measure: Improvement in Patient Assessment Constipation Quality of Life
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Medipol University Esenler Hospital
state: Other (Non U.s.)
Study officials:
References: