louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04725968: Morbimortality in Major Urgent General Surgery in the Geriatric Patient.
Official title: Morbimortality in Major Urgent General Surgery in the Geriatric Patient. Observational Study of Retrospective Cohort.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery--Complications
Emergencies
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 120
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the geriatric patients operated of urgent major general surgery in our centre during 2018.

Brief summary: Retrospective observational cohort study of geriatric patients operated of urgent major general surgery in our centre during 2018.

Our principal goals are:

1. To evaluate the incidence of post operation complications and its severity (defined by the Claiven-Dindo scale)
2. To evaluate the mortality: global mortality and mortality after: 30 days, 6 months and 1 year.


Eligibility criteria: Inclusion Criteria:

* Surgeries on the small and / or large bowel with or without intestinal resection, total colectomies, exploratory laparotomies

Exclusion Criteria:

* Polytraumatic patient, reoperations (for any cause) of scheduled and urgent surgeries

Primary outcomes:
measure: Incidence of complications
timeFrame: 30 days after surgery
measure: Mortality rate
timeFrame: 1 year
Secondary outcomes:
measure: Days of admission
timeFrame: 30 days after surgery
measure: days in ICU/Reanimation
timeFrame: 30 days after surgery
measure: NELA Risk Score
timeFrame: pre-surgery
measure: NSQUIP Risk Score
timeFrame: pre-surgery
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References:
Clinical trial NCT02756468: Procalcitonin Reveals Early Dehiscence in Pancreatic Surgery: the PREDIPS Study
Official title: Procalcitonin Reveals Early Dehiscence in Pancreatic Surgery: the PREDIPS Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Cancer
Keywords: pancreatic cancer
procalcitonin
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all pts undergoing pacreatic resections for cancer

Brief summary: Background. Pancreatic cancer surgery is associated with very high risk of postoperative morbidity and mortality. Anastomotic leak (AL) is one of the worst complications associated with relevant short and long-term sequelae. Procalcitonin (PCT) is a biomarker used to monitor bacterial infections and guide antibiotic therapy and has been shown to have better predictive value of AL after colorectal surgery than C-reactive protein (CRP) and white blood cell count (WBC).

Purpose. The investigators designed a monocentric pilot study to test if PCT might be a sensitive and reliable marker of AL after pancreatic surgery


Eligibility criteria: Inclusion Criteria:

* patients undergoing all different kinds of pancreatic surgery
* in elective setting
* for cancer
* with a pancreatic anastomosis performed.

Exclusion Criteria:

* age \< 18 years
* pregnant women
* patients undergoing pancreatic surgery for benign disease, other kinds of pancreatic surgery without an anastomosis being performed

Primary outcomes:
measure: Sensitivity of PCT and CRP for anastomotic leak (AL) after pancreatic surgery
timeFrame: 2 yrs
measure: Specificity of PCT and CRP for anastomotic leak (AL) after pancreatic surgery
timeFrame: 2 yrs
Secondary outcomes:
measure: PCT and CRP cuts-off in 3rd POD with a good NPV for AL
timeFrame: 2 yrs
measure: PCT and CRP cuts-off in 5th POD with a good NPV for AL
timeFrame: 2 yrs
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Sant'Andrea University Hospital
Study officials:
References:
Clinical trial NCT04445168: Randomized Trial of Exercise Promotion in Primary Care
Official title: Intervention Based in Primary Care to Increase Physical Activity Among Inactive Adults With Prediabetes and Diabetes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: PreDiabetes
Diabetes
Sedentary Behavior
Keywords: Physical activity
Randomized trial
Primary care
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2020-06-24
Enrollment: 451
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Millions of Americans have diabetes or prediabetes, for which regular physical activity can reduce risks of unfavorable outcomes of these conditions. This study will test the effects of an evidence-based intervention in the primary care setting on increasing physical activity among these individuals. If effective, it can be broadly implemented in primary care.


Eligibility criteria: Inclusion Criteria:

Able to speak English or Spanish, Inactive defined as less than 30 minutes of MVPA per week, Prediabetes or diabetes not prescribed insulin, Kaiser Permanente member for at least 12 months, Receives primary care at the Fontana Medical Center, Body mass index between 18.5 and 40 kg/m2,

Exclusion Criteria:

Current use of insulin, Cardiovascular event in the past 6 months or other condition that limits physical activity, Pregnancy, breastfeeding or planning pregnancy in next 2 years, Current participation in another clinical trial or research study, Plans to move out of the area in next 2 years,

Primary outcomes:
measure: Moderate to vigorous physical activity (MVPA)
timeFrame: 12 months
measure: Moderate to vigorous physical activity (MVPA)
timeFrame: 24 months
Secondary outcomes:
measure: Weight
timeFrame: 12 months
measure: Weight
timeFrame: 24 months
measure: Systolic blood pressure
timeFrame: 12 months
measure: Systolic blood pressure
timeFrame: 24 months
measure: Diastolic blood pressure
timeFrame: 12 months
measure: Diastolic blood pressure
timeFrame: 24 months
measure: HbA1c
timeFrame: 12 months
measure: HbA1c
timeFrame: 24 months
measure: Health-related quality of life
timeFrame: 12 months
measure: Health-related quality of life
timeFrame: 24 months
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Kaiser Permanente Southern California
state: California
Study officials:
References:
Clinical trial NCT06653868: Grafting of the Peri-implant Bony Defects Around Immediate Implants Using Xenogenic Versus Alloplastic Sticky Grafts: Randomized Controlled Clinical Trial
Official title: Grafting of the Peri-implant Bony Defects Around Immediate Implants Using Xenogenic Versus Alloplastic Sticky Grafts: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bone Loss, Alveolar
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-10-22
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In patients with a single non restorable tooth, does filling the peri-implant buccal gap with alloplastic sticky grafts result comparable results compared to xenogenic sticky grafts?

Detailed description: The buccal aspect of the dental implant has great importance, especially in the aesthetic zone, because the buccal bone is very thin especially in the anterior maxilla and its resorption can result in recession of the soft tissue. A gap occurs in immediately placed implant due to discrepancy between the dimensions of the extraction socket and the implant. Augmentation of the buccal gap decreases the amount of buccal bone resorption and soft tissue recession . Filling the peri-implant defects has been widely discussed to prevent further bone loss. The use of biologic materials such as platelet rich fibrin can enhance the quality of alloplastic bone grafts to give comparable effect when compared to xenogenic grafts.

Eligibility criteria: Inclusion Criteria:

1. Patients with healthy systemic condition (Mazzotti et al., 2023).
2. Age from 20-50 years old
3. Patients must be free of any systemic disease which could influence the surgical procedure.
4. Tooth involved in the esthetic zone.
5. Sufficient hard and soft tissue volume in vertical and buccolingual direction
6. Natural teeth adjacent to the involved tooth will be required to be free from infection.
7. Controlled oral hygiene.
8. Indication for tooth extraction included (Degidi et al., 2012);

   * Endodontic failures
   * Untreatable caries
   * Non- restorable teeth
   * Vertical root fracture
   * Remaining roots

Exclusion Criteria:

- 1.Pregnant females 2.Smokers (Khuller, 2009) 3.Unmotivated and uncooperative patients with poor oral hygiene 4.Patients with habits that may compromise the longevity and affect the result of the study as alcoholism or parafunctional habits.

5.Presence of acute dento-alveolar infection.

Primary outcomes:
measure: bone changes
timeFrame: 6 months
Secondary outcomes:
measure: pink esthetic score
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University
city: Cairo
country: Egypt
facility: Cairo University
Study officials:
References:
Clinical trial NCT00173368: Study of Endoscopic Sphincterotomy With Needle Knife Papillotome in Patients of Ampullary Impacted Stone
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Choledocholithiasis
Endoscopy
Keywords: Sphincterotomy
needle knife
hemorrhage
complication
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: Using a needle knife papillotome by an experienced endoscopist, endoscopic sphincterotomies were performed in difficult cannulation cases. In a prospectively collected database, we investigate the complications of those with ampullary impacted stone.

Detailed description: The endoscopic sphincterotomy with needle knife papillotome is a well-established advanced endoscopic technique in difficult cannulation cases. Choledocholithiasis impacted at the ampulla of Vater is occasionally seen. Inflammed surrounding mucosa frequently accompanies. Whether sphincterotomy with a needle knife increases the bleeding complications is to be elucidated in this study.

Eligibility criteria: Inclusion Criteria:

* choledocholithiasis patients and an ampullary impacted stone

Exclusion Criteria:

* patients with liver cirrhosis , pregnancy, history of abdominal malignancy, bleeding diathesis, ileus, renal failure

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: National Taiwan University Hospital
name: Hsiu-Po Wang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02309268: Atrial Appendage Closure Prospective Observational Study
Official title: LARIAT: Atrial Appendage Closure Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Atrial Fibrillation
Left Atrial Appendage Closure
Keywords: left atrial appendage closure
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2014-12-05
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being asked to take part in this study have a heart disorder known as atrial fibrillation (AF) and are poor candidates to take blood thinning drug known as warfarin (Coumadin), and have elected to undergo LARIAT procedure.

Brief summary: The purpose of this research is to monitor how well patients do after surgery for treatment of left atrial appendage (LAA).

Detailed description: Patients will be followed in an observational study. We propose to do a single follow-up TEE at 3 to 6 months (this is standard of care) to confirm LAA (left atrial appendage) occlusion. The TEE is not mandatory (this is not a clinical trial), but will be strongly recommended to patients to confirm the efficacy of treatment. This will help confirm whether patients may safely remain off anticoagulation. The risks of TEE are a less than 1 in 1000 risk of death, and a 1% or less risk of a major complication, such as esophageal perforation.

Eligibility criteria: Inclusion Criteria:

* Patients with Atrial fibrillation
* Are poor candidates to take warfarin
* Have elected to undergo a LARIAT procedure

Exclusion Criteria:

* none

Primary outcomes:
measure: Clinical Progress
timeFrame: At regular visits ( 3 months and annually)
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Medical Center
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: kenneth A Ellenbogen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02029768: Gender Disparity in Burn Injury Survival
Official title: Gender Disparity in Burn Injury Survival
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obesity
Burn Injury
Keywords: outcome
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
Collaborators: name: Laura W. Bush Institute for Women's Health
First posted: 2014-01-08
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population will be derived from adult patients admitted to the University Medical Center with greater than 15% total body surface area burns

Brief summary: Hypothesis 1: A quantifiable difference in inflammatory cytokines exist in women with burn injury and this correlates with clinical markers of outcome

Hypothesis 2: The amount of adipose tissue contributes to the severity of cellular immune response (CMI) dysregulation in response to burn injury

Skin-fold caliper measurements will be taken on consented patients (both male and female) to determine body fat percentage. Serum samples will be obtained from these patients. The level of inflammatory cytokines in the serum will be measured to determine if there is a link between body fat percentage, pro-inflammatory cytokines and the ability of women to survive burn injury.

Detailed description: Consented patients admitted to University Medical Center with greater than 15% total body surface area burns will participate in this study. A skin-fold caliper measurement will be performed to determine body fat percentage. Serum samples will be obtained and assayed for inflammatory cytokines to establish whether or not a link between obesity in women and pro-inflammatory cytokines exists. If so, obesity may be a factor which contributes to the gender disparity in burn wound survival.

Eligibility criteria: Inclusion Criteria:

* Men and women ages 18 to 65 years
* Admitted to University Medical Center with greater than 15% total body surface area burns
* Able to provide informed consent or has authorized representative to give informed consent

Exclusion Criteria:

* Prisoners or pregnant women
* Individuals with injuries that preclude taking caliper measurements

Primary outcomes:
measure: Inflammatory cytokine levels
timeFrame: 72 hours post admission until patient discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center/University Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT04800068: Expanded Access [Ga-68] PSMA-11 PET Imaging
Official title: Expanded Access [Ga-68] PSMA-11 PET Imaging
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Prostate Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-03-16
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: In this expanded access IND study, Mayo Clinic in Rochester MN offers \[Ga-68\] PSMA-11 PET/CT or PET/MR imaging to patients who meet criteria.

Detailed description: \[Ga-68\] PSMA-11 PET/CT and PET/MR imaging has been shown to allow for accurate detection of metastatic prostate cancer at the time of initial diagnosis and staging of patients with high-risk prostate cancer and at the time of biochemical recurrence. In addition, available data show superiority of metastatic lesion detection with \[Ga-68\] PSMA-11 PET over conventional imaging. This improved lesion detection has a direct impact on selection of anti-cancer therapy and thus may improve patient outcomes.

Under expanded access IND, enrolled patients will receive a clinical \[68Ga\] PSMA-11 PET/CT or PET/MR for evaluation of their cancer. Imaging exams must be deemed clinically indicated by a referring provider. Patients will be responsible for the cost of the imaging exam. Access is limited.

Eligibility criteria: Participant Groups

There are two participant groups; please refer to the inclusion details below:

Group 1: Untreated High-Risk prostate cancer group (must meet at least one of the following inclusion criteria):

1. Serum prostate-specific antigen (PSA) concentration of 20 ng/mL or more
2. Pathologic criteria of International Society of Uropathology (ISUP) grade group 3-5 (ISUP grades 3-5 are equivalent to pathologic Gleason scores of 4+3, 8, 9 or 10)
3. Local staging of T3 or worse (Indicating that cancer has invaded into tissues outside of the prostate gland, as seen at either CT or MRI)

Biochemically Recurrent prostate cancer group (must meet one of the criteria):

1. In patients who have undergone a prostatectomy, PSA \> 0.2 ng/ml on 2 consecutive tests
2. In patients who have undergone definitive prostate radiation, PSA rise ≥ 2 ng/mL above the nadir PSA

Exclusion Criteria: Current exclusion criteria for both groups includes:

1. Patients unable to sign informed consent
2. Patient with a life expectancy less than 6 months
3. Additional exclusion criteria may be added based on demand

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
References:
Clinical trial NCT02250768: Effects of Embryogen in RIF Patients
Official title: Effects of Granulocyte - Macrophage Colony - Stimulating Factor (GM-CSF) Supplementation in Embryo Culture in Patients With Repeated Implantation Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: GM-CSF, repeated implantation failure
Lead sponsor: Vietnam National University
Sponsor class: OTHER
First posted: 2014-09-26
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to investigate the potential effects of Granulocyte-Macrophage Stimulating-Colony Factor (GM-CSF) supplementation in embryo culture for patients with repeated implantation failure (RIF)

Detailed description: 60 patients with repeated implantation failure were involved.

RIF was defined as patients failed to conceive (beta-hCG \< 5 mIU/mL) after at least 03 embryo transfers (fresh and frozen) with 06 top quality embryos or more.

Ovarian stimulation was performed using GnRH antagonist protocol. All matured oocytes were inseminated by ICSI. Injected oocytes were cultured in medium supplemented with 2ng/ml of GM-CSF (Embryogen, Origio) until day of transfer. Embryo evaluation was performed at ﬁxed time points of 18 and 44 hour after fertilization. Embryo transfer was performed 2 days after ovum retrieval.

Luteal-phase support was provided using progesterone gel (Crinone 8% 90 mg, twice a day; Merck Serono) and estradiol per os (Valiera 2mg, twice a day; Laboratorios Recalcine). Serum hCG was measured 16 days after oocyte retrieval, and if positive, an ultrasound scan was performed at gestational weeks 7 and 12.

Eligibility criteria: Inclusion Criteria:

* Normal ovarian reserve (AMH \> 1.1 ng/ml)
* Regular menstrual cycle (25 - 34 days)
* Clear informations about at least 3 latest IVF/ET
* Fresh embryo transfer in this cycle
* Endometrial thickness of 10 mm or more

Exclusion Criteria:

* Undergo oocyte donation or in vitro maturation (IVM) cycles
* Using frozen or surgically retrieved sperm
* Adenomyosis, Uterine anomaly, uterine fibroid, hydrosalpinges
* In participation in other studies/interventions

Primary outcomes:
measure: ongoing pregnancy rate
timeFrame: 12 week of gestation
Secondary outcomes:
measure: Implantation rate
timeFrame: 7 week of gestation
measure: clinical pregnancy rate
timeFrame: 7 week of gestation
measure: top quality embryo rate
timeFrame: 44 hours after insemination
Other outcomes:
Locations:
city: Ho Chi Minh
country: Vietnam
facility: An Sinh Hospital
Study officials:
affiliation: Research Center for Genetics and Reproductive Health
name: Vinh Q Dang, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01345968: Intravenous Ferric Carboxymaltose (Ferinject) in Patients Undergoing Orthopaedic Surgery
Official title: Preoperative Intravenous Ferric Carboxymaltose (Ferinject) in Patients With Orthopedic Surgery and High Risk of Blood Loss
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Anemia
Orthopedic Surgery
High Risk of Blood Loss
Keywords: anemia
transfusion
intravenous ferric carboxymaltose
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
Collaborators: name: Vifor Pharma
First posted: 2011-05-02
Enrollment: 3
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: The primary purpose of this study is to evaluate the safety and efficacy of preoperative intravenous ferric carboxymaltose in patients with anemia undergoing hip or knee replacement


Eligibility criteria: Inclusion Criteria:

* age \>= 18 years
* Patients scheduled to undergo hip or knee replacement
* 8 g/dl \< Hb \< 13 g/dl for men and 8 g/dl \< Hb \< 12 g/dl for women at screening (3-4 weeks prior to surgery)
* anemia
* signed written informed consent

Exclusion Criteria:

* immunosuppressive or myelosuppressive therapy
* history of thromboembolic events
* a concurrent medical condition(s) that would prevent compliance or participation or jeopardize the health of the patient
* hypersensitivity to any component of the formulation
* transfusion within 1 month prior to study inclusion
* liver values 3 times higher than normal
* active severe infection/inflammation
* renal insufficiency

Primary outcomes:
measure: Number of RBC units
timeFrame: Until postoperative day 7
Secondary outcomes:
measure: Blood transfusion rate
timeFrame: Until postoperative day 7
measure: Frequency of postoperative complications
timeFrame: Until postoperative day 7
measure: Frequency of postoperative complications
timeFrame: Until 6 weeks after surgical intervention
measure: Length of hospital stay
timeFrame: 6 weeks after surgical intervention
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Muenster
country: Germany
facility: University Hospital Muenster
Study officials:
affiliation: Department of Anesthesia and Intensiv Care, University Hospital Muenster
name: Hugo K Van Aken, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: