louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05044624: Retroperıtoneal Soft-Tıssue Sarcomas
Official title: Retroperıtoneal Soft-Tıssue Sarcomas: Retrospectıve Clınıcal Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retroperitoneal Sarcoma
Margin, Tumor-Free
Keywords: Soft tissue sarcoma
Surgery
Multidisciplinary Sarcoma Team
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: : Soft Tissue Sarcomas are rare mesenchymal tumors with many subtypes. Clean margin-wide resection is recommended for treatment. The guidelines recommend that sarcoma treatments be carried out in sarcoma centers. In this study, the location, histopathological features, clinical and demographic features, recurrence, and prognosis of retroperitoneal sarcomas were investigated.

Detailed description: The demographic, histopathological, and immunohistochemical data of the patients who were operated on with the diagnosis of intraabdominal mass at Istanbul Medeniyet University Göztepe Prof. Dr. Süleyman Yalçın City Hospital from March 2016 to December 2020 were retrospectively evaluated. Ethical approval was obtained from Istanbul Medeniyet University Göztepe Prof. Dr. Süleyman Yalçın City Hospital Ethics Committee.

Patients diagnosed with pathological sarcoma subclass were included in the study. Patients younger than 18 years were excluded from the study. Visceral organ-origin sarcomas and extremity sarcomas were also excluded from the study. GIST's were included in sarcoma subtypes by WHO in 2013. However, they were not included in the study due to their solid organ origin.

The data of 18 patients' whore remained after the exclusion criteria were analyzed retrospectively. Pathology samples of the patients were re-examined by a single pathologist.

The demographic analysis was used for statistics.

Eligibility criteria: Inclusion Criteria:

* Patients operated with the diagnosis of intra-abdominal mass
* patients diagnosed with pathological sarcoma subclasses

Exclusion Criteria:

* Patients younger than 18 years
* Visceral organ-origin sarcomas
* extremity sarcomas
* GIST

Primary outcomes:
measure: Clean margin wide resection
timeFrame: 63 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01929824: Nasal Nitric Oxide Levels in Eosinophilic Esophagitis (EoE)
Official title: A Pilot Study: Nasal Nitric Oxide Levels in Eosinophilic Esophagitis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eosinophilic Esophagitis
Keywords: dysphagia, trouble swallowing, chest pain
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2013-08-28
Enrollment: 50
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 with eosinophilic esophagitis

Brief summary: This study is aimed at understanding whether oral nitric oxide levels can be used as a non-invasive marker for the diagnosis and management of patient with eosinophilic esophagitis (EoE).

Detailed description: Nitric oxide (NO) is produced by activated eosinophils and oral NO levels are known to be elevated in asthma and eosinophilic bronchitis. The measurement of oral NO is a non-invasive,easy to perform low cost procedure that is used frequently in the diagnosis and management of asthma. The diagnosis of eosinophilic esophagitis (EoE) requires conscious sedation, an upper endoscopy with biopsy, and histologic evaluation of the biopsy specimen. This is a costly and somewhat invasive procedure. If oral NO was elevated as a result of activity of esophageal eosinophils in EoE, the measurement of oral NO may potentially be a very convenient and useful test in the evaluation and treatment of EoE. We propose a pilot study to determine if oral NO levels are elevated in patients with eosinophilic esophagitis.

Eligibility criteria: Inclusion criteria:

* Subjects with dysphagia and active esophageal infiltration (esophageal eosinophilic count of \>/= 15 eos/hpf)
* Subjects with or without a clinical diagnosis of asthma

Exclusion criteria:

* Subjects with chronic cough
* Severe CAD
* MI within the last 3 months
* Cystic fibrosis
* Tuberculosis
* Chronic obstructive pulmonary disease (COPD)

Primary outcomes:
measure: Number of patients with increase in Oral Nitric Oxide levels
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Vivek Iyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05247424: Pretreatment With Unfractionated Heparin for ST Elevation Myocardial Infarction
Official title: Pretreatment With Unfractionated Heparin for ST Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: STEMI - ST Elevation Myocardial Infarction
Keywords: Myocardial Reperfusion
Unfractionated heparin
pre-treatment
Lead sponsor: University Medical Centre Ljubljana
Sponsor class: OTHER
First posted: 2022-02-18
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomization in 1:1 ratio
Primary purpose: TREATMENT

Brief summary: Rupture of a coronary artery plaque leads to thrombotic occlusion of the coronary artery and would present as ST segment elevation myocardial infarction. Early treatment with aspirin and early primary percutaneous coronary intervention are indicated. Anticoagulation therapy, usually with unfractionated heparin, is required during percutaneous coronary intervention.

Investigators hypothesis is that pretreatment with unfractionated heparin in addition to aspirin at first medical contact may facilitate spontaneous reperfusion of culprit artery and procedural thrombotic complication in patients with ST elevation myocardial infarction without significant risk of bleeding complications.

Detailed description: Randomization of patients with STEMI at first medical contact in a 1:1 ratio into an intervention group receiving 100 IU of unfractionated heparin (UFH) per kilogram of body weight IV and later additionally UFH after diagnostic coronary angiography according to the activated clotting time (ACT) and a control group receiving only UFH after diagnostic coronary angiography at the dose of 100 IU per kilogram of body weight.

The primary end point of the study is TIMI flow at coronary angiography. Secondary endpoints are: Bleeding complications (defined by BARC score), occurrence of cardiogenic shock, and 30-day mortality.

Investigators plan to randomize 600 patients.

Eligibility criteria: Inclusion Criteria:

* Adult patients with STEMI referred for primary PCI
* Duration of symptoms less than 6 hours before presentation

Exclusion Criteria:

* Pregnancy
* Cardiogenic shock at presentation (hemodynamic instability)
* Cardiac arrest before randomization
* Duration of symptoms for more than 6 hours before presentation

Primary outcomes:
measure: TIMI flow
timeFrame: Day 0
Secondary outcomes:
measure: Bleeding
timeFrame: Day 0
measure: Cardiogenic shock
timeFrame: Day 0 to 10
measure: 30 day mortality after STEMI
timeFrame: 30 days
measure: Troponin I concentration 24 h after primary PCI
timeFrame: 24 h
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: UMC Ljubljana
Study officials:
affiliation: UMC Ljubljana
name: Miša Fister, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00144924: Open vs Laparoscopic Pyloromyotomy for Pyloric Stenosis
Official title: Recovery After Open Versus Laparoscopic Pyloromyotomy for Pyloric Stenosis: a Double-blind Multicentre Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pyloric Stenosis
Lead sponsor: Institute of Child Health
Sponsor class: OTHER
First posted: 2005-09-05
Enrollment: 180
Sex: ALL
Minimum age (years): 0
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Comparison of open and laparoscopic pyloromyotomy


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of infantile hypertrophic pyloric stenosis

Exclusion Criteria:

* Presence of co-existing congenital or chromosomal abnormality
* The need to perform any additional procedure at the time of pylotomyotomy
* Failure to receive informed consent

Primary outcomes:
measure: Time to full feeds
timeFrame: 6 weeks
measure: Post operative length of stay
timeFrame: 6 weeks
measure: Episodes of post-operative vomiting
timeFrame: 24h
Secondary outcomes:
measure: Peri-operative complications
timeFrame: 24h
measure: Post-operative complications
timeFrame: 6 weeks
measure: Anaesthetic time
timeFrame: 24h
measure: Operating time
timeFrame: 24h
measure: Post-operative pain and analgesia requirements
timeFrame: 6 weeks
measure: Cosmetic outcome
timeFrame: 6 weeks
measure: Total in-hospital costs
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Institute of Child Health/Great Ormond Street Hospital
Study officials:
affiliation: Institute of Child Health
name: Nigel Hall, Mr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hall NJ, Pacilli M, Eaton S, Reblock K, Gaines BA, Pastor A, Langer JC, Koivusalo AI, Pakarinen MP, Stroedter L, Beyerlein S, Haddad M, Clarke S, Ford H, Pierro A. Recovery after open versus laparoscopic pyloromyotomy for pyloric stenosis: a double-blind multicentre randomised controlled trial. Lancet. 2009 Jan 31;373(9661):390-8. doi: 10.1016/S0140-6736(09)60006-4. Epub 2009 Jan 18.
citation: Carrington EV, Hall NJ, Pacilli M, Drake DP, Curry JI, Kiely EM, De Coppi P, Pierro A, Eaton S. Cost-effectiveness of laparoscopic versus open pyloromyotomy. J Surg Res. 2012 Nov;178(1):315-20. doi: 10.1016/j.jss.2012.01.031. Epub 2012 Mar 27.
Clinical trial NCT00800124: Study on Cemented Versus Non-cemented Hemiarthroplasty in Elderly With Hip Fractures
Official title: A Prospective Randomized Multicenter Study on Cemented and Non-cemented Hemiprosthesis in Older Patients With Dislocated Hip Fracture.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hip Fracture
Keywords: hip fracture
hemiprosthesis
bone cement
clinical outcome
Lead sponsor: Sykehuset Innlandet HF
Sponsor class: OTHER
Collaborators: name: Rikshospitalet University Hospital
name: Sykehuset Buskerud HF
First posted: 2008-12-01
Enrollment: 334
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to study the overall frequency and cumulative rate (during one year) of clinical morbidity (defined as any hospitalization without fatal outcome) and mortality in all consecutive patients undergoing HF surgery (pins and prosthetic implants) and compare this to the group of patients receiving prosthetic implants and further find out if there is a difference between the non-cemented and cemented groups.

Between the same prosthetic groups, the investigators want to study the overall frequency of in-hospital subclinical organ damage and dysfunction of myocardium, liver and lungs, using biochemical plasma markers. Finally, the investigators want to perform perioperative cost benefit calculations and out of hospital quality of life analysis between the surgical groups.


Eligibility criteria: Inclusion Criteria:

* Patient with Garden 3 or 4 fracture in acute hip fractures.
* Age over 75 years.

Exclusion Criteria:

* Patient or relative refuse enrollment

Primary outcomes:
measure: Mortality
timeFrame: 1 year after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Elverum
country: Norway
facility: Sykehuset Innlandet, Elverum
state: Hedmark
Study officials:
affiliation: Sykehsuet Innlandet, Elverum
name: Ove Talsnes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02208024: Neoadjuvant Stereotactic Body Radiation Therapy for Resectable Adenocarcinoma of the Pancreatic Head and/or Body
Official title: Phase I Study to Evaluate the Feasibility of Neoadjuvant Stereotactic Body Radiation Therapy for Resectable Adenocarcinoma of the Pancreatic Head and/or Body
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2014-08-04
Enrollment: 18
Sex: ALL
Minimum age (years): 19
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 test the safety of focused radiation (Stereotactic Body Radiation Therapy, SBRT) on patients with pancreatic cancer that will be removed surgically.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years.
* Histologically confirmed pancreatic adenocarcinoma of the head and/or body; at least the majority of the histopathologic specimen must be identified as adenocarcinoma.
* Pancreatic tumors must be considered resectable at time of treatment planning. Definition of resectable: no metastases, less than 180 degree involvement of superior mesenteric vein or portal vein, no involvement of hepatic artery, superior mesenteric artery or celiac artery
* No active infection requiring hospitalization
* Adequate labs
* Life expectancy \> 3 months.
* Patient is to have received chemotherapy prior to enrollment. This will typically consist of 3-4 cycles of chemotherapy. Patients will have a 2 week break between last chemotherapy administration and start of SBRT.

Exclusion Criteria:

* Presence of metastatic disease.
* Infections requiring systemic antibiotic treatment.

Primary outcomes:
measure: Number of Participants With Acute (Within 3 Months of Treatment) Grade 3 or Greater Gastrointestinal Toxicity
timeFrame: 3 months
Secondary outcomes:
measure: Number of Participants With Late (Greater Than 3 Months After Treatment) Grade 2 Gastritis, Enteritis, Fistula, and Ulcer or Any Other Grade 3 or Greater Gastrointestinal Toxicity
timeFrame: 1 year
measure: Local Progression Free Survival
timeFrame: 1 year
measure: Metastasis Free Survival
timeFrame: 1 year
measure: Overall Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Michelle Mierzwa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01231724: Topical Allstate and Nasal Allergen Challenge
Official title: A Randomized, Double-Blind, Placebo-Controlled, Cross-Over Trial of Topical Allstate in the Prevention of the Signs and Symptoms of the Acute Response to Nasal Allergen Challenge (CETALY0001)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Allergic Rhinitis
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
First posted: 2010-11-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see whether Allstate Nasal Spray when given in the nose is safe and can reduce the signs and symptoms of allergic rhinitis (hayfever).


Eligibility criteria: Inclusion Criteria

1. Males and females between 18 and 55 years of age.
2. History of grass and/or ragweed allergic rhinitis for at least 2 years.
3. Positive skin test to grass and/or ragweed antigen within prior 12 months.
4. Positive response to screening nasal challenge.

Exclusion Criteria

1. Respiratory disease other than allergic rhinitis, allergic conjunctivitis and mild asthma.
2. Use of nasal steroids, antihistamines in the last 2 weeks.
3. Upper respiratory infection, sinusitis less than 2 weeks before screening.
4. Structural nasal abnormalities or nasal polyps on examination, nasal ulcer, frequent nose bleeding, recent nasal surgery or nasal trauma (within 90 days).
5. Having poorly tolerated previous administration of allergens
6. Nasolacrimal drainage system malfunctions.
7. Participation in other investigational therapy in the last 30 days.
8. Any systemic disorder or medication interfering with the study.
9. FEV1\<80% of predicted at screening for subjects with mild asthma.
10. Presence of allergic rhinitis symptoms in the screening period with TNSS \>3 at baseline)
11. Undergoing allergen desensitization therapy.
12. Current smokers or recent ex-smokers.
13. Not willing to give informed consent
14. Inability to understand the nature and requirements of the study, or to comply with the study procedures.
15. Any social or medical condition that, in the opinion of the investigator, would preclude provision of informed consent, make participation in the study unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.

Primary outcomes:
measure: Number of sneezes and total nasal symptom score (TNSS) (sum of nasal stuffiness, nasal discharge, and nasal itching) (scale 0-3 for each symptom; total score 0-9) are co-primary endpoints.
timeFrame: 10 minutes following each nasal challenge
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Robert M Naclerio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04198324: Isthmocele After Endometrial and Non-endometrial Suturing in Cesarean Section
Official title: Isthmocele After Endometrial and Non-endometrial Suturing in Cesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section; Dehiscence
Cesarean Wound; Dehiscence
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 170
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Closure of the hysterotomy at the time of primary cesarean section
Primary purpose: PREVENTION

Brief summary: This study compares the effect of two techniques of uterine closure, with or without endometrial suturing on isthmocele development after cesarean section.

Detailed description: Cesarean section is the most common surgery performed on pregnant women. Poor healing of the incision of the uterus leads to isthmocele development. Long-term morbidities associated with isthmocele are uterine scar pregnancy, uterine perforation, pelvic pain, and spotting-style bleeding after menstruation. Many factors that may affect the healing of uterine scar have been studied in the literature (i.e. Double or single-layer closure, locked or unlocked closure, uterine retroflection). Suturing complete fold of the wound lips during the closure of the uterus may cause the endometrial layer to be embedded in the myometrium and to form niche tissue. The study hypothesized that isthmocele development can be reduced by suturing without enclosing the endometrium during uterine closure.

Eligibility criteria: Inclusion Criteria:

* Term pregnancy (≥37 weeks of gestation)
* Singleton pregnancy
* Primary cesarean

Exclusion Criteria:

* Previous cesarean section
* Previous uterine surgery
* Multiple gestations
* Mullerian anomalies
* Active labor
* Placenta previa/accreta

Primary outcomes:
measure: Number of patients with isthmocele six month after cesarean section
timeFrame: 6 months after intervention
measure: Mean myometrium thickness
timeFrame: 6 months after intervention
Secondary outcomes:
measure: Spotting
timeFrame: 6 months after intervention
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
affiliation: Kocaeli University
name: Şener Gezer, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bij de Vaate AJ, van der Voet LF, Naji O, Witmer M, Veersema S, Brolmann HA, Bourne T, Huirne JA. Prevalence, potential risk factors for development and symptoms related to the presence of uterine niches following Cesarean section: systematic review. Ultrasound Obstet Gynecol. 2014 Apr;43(4):372-82. doi: 10.1002/uog.13199.
Clinical trial NCT02613624: Formative Research to Develop an Intervention Package to Promote Practice of Kangaroo Mother Care for Low Birth Weight and Preterm Infants in a Community (CKMC)
Official title: Formative Research to Develop an Intervention Package for Promotion of Kangaroo Mother Care for Low Birth Weight and Preterm Infants in a Community: In Preparation for a Randomized Controlled Trial to Examine Impact of Community Kangaroo Mother Care on Neonatal and Early Infant Mortality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low-Birth-Weight
Keywords: KMC in community
Lead sponsor: Society for Applied Studies
Sponsor class: OTHER
Collaborators: name: Centre For International Health
First posted: 2015-11-24
Enrollment: 28
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Rural and semi urban population of two primary health centre areas in two districts of the state of Haryana, India.

Brief summary: The study is being conducted to develop an intervention to assess the feasibility of implementing Kangaroo Mother Care (KMC) for low birth weight (LBW) and preterm babies in a community setting. A prototype intervention package will be developed using information obtained from in-depth interviews, focus group discussions and other qualitative research techniques. These interviews will help us identify current behaviours, barriers to adoption of KMC and effective ways to promote KMC in the community. The prototype intervention will be refined by conducting acceptability studies (household trials) with few mothers. The study team are identifying LBW and preterm infants, demonstrating to mothers how to practice KMC and following up till KMC is stopped. The process is being documented using observations and interviews. Information is obtained on acceptability of KMC, number of hours per day and number of days KMC was given, breastfeeding practices and support provided by other family members.


Eligibility criteria: Inclusion Criteria:

* Low birth weight or preterm newborns

Exclusion Criteria:

* Babies with hospitalization criteria
* unable to feed or weight less than 1500 grams at birth

Primary outcomes:
measure: Feasibility and acceptability of community based KMC
timeFrame: 1 year
measure: Define intervention package
timeFrame: 1 year
Secondary outcomes:
measure: Perceptions and practices of maternal and newborn care
timeFrame: 1 year
measure: Social norms around birthing practices
timeFrame: 1 year
measure: Awareness and perception around KMC
timeFrame: 1 year
measure: Promotion of KMC
timeFrame: 1 year
Other outcomes:
Locations:
city: Palwal
country: India
facility: CHRD, Society for Applied Studies
state: Haryana
Study officials:
affiliation: Centre for Health Research and Development, Society for Applied Studies, New Delhi
name: Sarmila Mazumder, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: