louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02658318: Postoperative Complications After Cleft Palate Closure in Patients With Pierre Robin Sequence: Operative Considerations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pierre Robin Syndrome
Cleft Palate
Keywords: peri- and postoperative complications
airway obstruction
adapted Furlow palatoplasty
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2016-01-18
Enrollment: 92
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All cleft patients consecutively treated with a modified Furlow palatoplasty between 01/01/2011 and 31/08/2015 in the Department of Oral and Maxillofacial Surgery of the General Hospital Saint-John Bruges (Bruges, Belgium) or the Department of Pediatrics of the Semmelweis University (Budapest, Hungary)

Brief summary: In cleft surgery there is no current general agreement on the treatment strategy of patients with the Pierre Robin Sequence. The timing of surgery and the surgical approach depends on the treating physician or the hospital facility. Literature regarding peri- and postoperative complications in the target population are lacking.

The investigators aim to retrospectively review the charts of all cleft patients, both PRS and non-PRS, treated with an adapted Furlow palatoplasty between 01/01/2011 and 31/08/2015. The incidence of peri- and postoperative complications, with a specific focus on respiratory complications, will be examined. The value of demographic, surgical and postoperative parameters will be examined as potential risk factors for the development of complications.


Eligibility criteria: Inclusion Criteria:

* patients of all ages
* patients that had undergone a modified Furlow palatoplasty
* patients treated at the GH Saint-John Bruges (Belgium), or the cooperating Semmelweis University (Hungary)

Exclusion Criteria:

* patients not eligible according to the abovementioned criteria

Primary outcomes:
measure: Incidence of peri- and postoperative complications
timeFrame: within 4 weeks postoperative
Secondary outcomes:
measure: Identification of potential risk factors (demographic, diagnostic, surgical) for development of postoperative complications, through regression analysis
timeFrame: within 4 weeks postoperative
Other outcomes:
Locations:
city: Bruges
country: Belgium
facility: General Hospital Saint-John Bruges
Study officials:
affiliation: Maxillofacial surgeon, Head of Department
name: Johan Abeloos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01760018: Comparison Between Propofol-remifentanil Total Intravenous Anesthesia and Desflurane-remifentanil Balanced Anesthesia With Regard to Post-anesthetic Functional Recovery Measured With QoR-40
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Operation Under General Anesthesia
Keywords: desflurane, total intravenous anesthesia, QoR-40
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-01-03
Enrollment: 76
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Total intravenous anesthesia (TIVA) and inhalation anesthesia are both widely and safely used, and there are many clinical trials comparing these on various aspects of anesthesia. However, there have not been studies comparing the quality of recovery from the different methods of general anesthesia. In this study, the investigators compare the functional recovery after general anesthesia in TIVA and inhalation anesthesia with QoR-40 questionnaire.


Eligibility criteria: Inclusion Criteria:

* patients who are undergoing thyroid operation belong to ASA class 1 or 2

Exclusion Criteria:

* patients who are belongs to ASA class 3 or more,
* patients who have underlying complicated cardiovascular or psychological disease.

Primary outcomes:
measure: QoR-40 score
timeFrame: at 24 hours later after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
citation: Myles PS, Weitkamp B, Jones K, Melick J, Hensen S. Validity and reliability of a postoperative quality of recovery score: the QoR-40. Br J Anaesth. 2000 Jan;84(1):11-5. doi: 10.1093/oxfordjournals.bja.a013366.
citation: Lee WK, Kim MS, Kang SW, Kim S, Lee JR. Type of anaesthesia and patient quality of recovery: a randomized trial comparing propofol-remifentanil total i.v. anaesthesia with desflurane anaesthesia. Br J Anaesth. 2015 Apr;114(4):663-8. doi: 10.1093/bja/aeu405. Epub 2014 Dec 10.
Clinical trial NCT05456113: Topical Cannabidiol Application and Skin Vascular Reactivity
Official title: Cannabidiol and Vascular Reactivity to Skin Sensory Nerve Stimulation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Effect of Drug
Lead sponsor: Penn State University
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Cannabidiol, or CBD, is an over-the-counter "nutraceutical" that is more commonly being used by healthy adults for pain management, recovery from strenuous exercise, and general wellness. However, little research exists on the effects of CBD in otherwise healthy individuals. This study uses iontophoresis, a common technique used in physical therapy, to determine the effectiveness of topical CBD in lessening the reflex increased cutaneous vascular conductance response to stimulation of the skin.


Eligibility criteria: Inclusion Criteria:

* Men and women 18 years of age and older
* English speaking
* Non-obese class III, BMI ≤ 39.9
* Normal HbA1C of \<6.5%

Exclusion Criteria:

* Abnormal resting heart rate (\<60 or \>100 bpm) or BP (systolic \<100 or \>129 mmHg, diastolic \<60 or \>100 mmHg) values
* Rash, skin disease, disorders of pigmentation
* Known skin allergies
* Diabetes
* Nicotine use (e.g. smoking, chewing tobacco, vaping, etc.)
* Illegal drug use
* Recent (within the last 30 days) CBD users either topical or oral
* Allergy or hypersensitivity to investigational agents
* Women who are pregnant or breastfeeding

Primary outcomes:
measure: Cutaneous Vascular Conductance
timeFrame: ~5 hours
Secondary outcomes:
Other outcomes:
Locations:
city: University Park
country: United States
facility: Noll Laboratory
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03356613: GenI: a Tool to Generate Paramedical Research Ideas
Official title: GenI: a Tool to Generate Paramedical Research Ideas
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Paramedical Staff Views of Research
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2017-11-29
Enrollment: 52
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: paramedical staff

Brief summary: In order to develop paramedical research culture, the paramedical staff need adapted tools and methods. The GenI project (Research ideas generation) has for main objective the design and validation of a tool that will allow the identification of paramedical research ideas. This tool will be built based on paramedical staff views. Our hypothesis is that the use of the GenI tool will help to detect research ideas in paramedical health care that could lead to research projects.


Eligibility criteria: Inclusion Criteria:

* paramedical staff working in one of the 4 hospitals involved in the study

Exclusion Criteria:

* paramedical staff with a research degree
* paramedical staff that are paramedical coordinator in the hospital

Primary outcomes:
measure: Comparison of the number of research ideas generated by a group of experts and by a group of paramedical staff
timeFrame: in 1 year
measure: Comparison of the pertinence of research ideas generated by a group of experts and by a group of paramedical staff
timeFrame: in 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: CIC 1433 Epidémiologie clinique
Study officials:
affiliation: CHRU Nancy Brabois
name: Sylvie Klein
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06628713: Treatment of Angioedema Attacks in Adolescent and Adult Patients 12 Years and Older With HAE Type I or II With Sebetralstat
Official title: On Demand Treatment of Angioedema Attacks in Adolescent and Adult Post-Trial and Naive Patients 12 Years and Older With Hereditary Angioedema (HAE) Type I or II With Sebetralstat
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Hereditary Angioedema
Lead sponsor: KalVista Pharmaceuticals, Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-08
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The sebetralstat Early Access Program (EAP) provides early access to the investigational medicinal product (IMP) sebetralstat to eligible and approved Type I or II Hereditary Angioedema (HAE) adolescent and adult post-trial and naïve patients for the on-demand treatment of angioedema attacks where the treating Physician determines they might benefit from this treatment.


Eligibility criteria: Inclusion Criteria:

* At least 12 years of age.
* Able to provide written, informed consent or assent.
* Confirmed diagnosis of HAE Type I or II.

Exclusion Criteria:

* Confirmed diagnosis of HAE with nC1-INH or acquired angioedema.
* Confirmed pregnancy or breast-feeding.
* Any clinically significant medical condition or medical history that, in the opinion of the Treating Physician, would interfere with the patient's safety.
* Known hypersensitivity to sebetralstat or its excipients.
* Patient with a medical history or known to have severe hepatic impairment (Child Pugh C).
* Patients who require sustained use of strong cytochrome P450 3A4 inhibitors or inducers.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: KalVista Investigative Site
state: Arizona
Study officials:
References:
Clinical trial NCT05388513: Evaluating Factors Affecting Survival in Colon and Rectum Cancer
Official title: Evaluating Factors Affecting Survival in Colon and Rectum Cancer: A Prospective Cohort Study With 161 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Rectum Cancer
Keywords: Survival
Prognostic factors
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-05-24
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients with colon and rectum cancer operated were examined

Brief summary: Colorectal cancers are frequent among cancers of the gastrointestinal system. Whether there are any differences between survival in rectum and colon cancer patients is controversial. This study aimed to compare survival in the surgically treated rectum and colon cancers and determine the factors affecting survival.

Detailed description: Colorectal cancers are frequent in the gastrointestinal system. It is the 4th most common cancer after lung, prostate, and bladder in the male population and it is the 3rd after breast and thyroid cancers in the female population according to World Health Organization. It is considered significant morbidity and mortality cause and is estimated to develop in more than 1.000.000 individuals annually worldwide. Colorectal cancers form 10% of all cancers in the female and male populations. It is the 2nd most common cause of death among cancers in the United States of America.

In studies, it is stated that the risk of developing colorectal cancer in an individual is 5-6%. Also, the risk of death of an individual due to colorectal cancer was determined as 3%. In the last 50 years, the rate of colorectal cancer mortality decreased in the female population while it did not change in the male population. Whether there is a difference in survival time between rectum and colon cancers is controversial.

With the development in neoadjuvant treatment approaches, poor prognosis in past years got better. Recent studies show that the prognosis in rectum cancers is better than in colon. Nevertheless, factors affecting prognosis other than treatment for both colon and rectum cancers are not clarified.

In this study, the investigators aimed to evaluate the surgically treated rectum and colon cancer patients' survival and factors affecting survival time.

Eligibility criteria: Inclusion Criteria:

Patients who were operated and diagnosed histopathologically as adenocarcinoma were included.

Exclusion Criteria:

Inoperable and recurrent colorectal cancer patients and patients that were diagnosed with other than adenocarcinoma were excluded from the study.

Primary outcomes:
measure: Survival
timeFrame: 5 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Umraniye Education and Research Hospital
name: Fatih Başak
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00997113: Stress During Deep Sedation With Propofol With and Without Alfentanil
Official title: Physiologic Stress During Procedural Sedation With and Without Alfentanil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sedation
Keywords: propofol
alfentanil
procedural sedation
stress biomarkers
Deep procedural sedation in the ED
Lead sponsor: Hennepin Healthcare Research Institute
Sponsor class: OTHER
First posted: 2009-10-19
Enrollment: 20
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: This is a randomized clinical trial of deep procedural sedation with propofol with and without supplemental alfentanil. Patients will be assessed for total and fractionated serum catecholamines before and after the procedure in addition to usual procedural sedation outcomes parameters to assess the adrenergic effect of propofol sedation without supplemental opioid.


Eligibility criteria: Inclusion Criteria:

* patients who will require deep procedural sedation with propofol in the ED

Exclusion Criteria:

* age \<18
* intoxication
* unable to provide informed consent
* allergy to propofol or alfentanil
* pregnant
* ASA physical status score \> 2

Primary outcomes:
measure: Change in Serum Catecholamines
timeFrame: one minute prior to the start of the procedure and immediately at the end of sedation procedure (median time of procedure 12 minutes range 6-26 minutes
Secondary outcomes:
measure: Respiratory Depression
timeFrame: From one minute prior to the start of the sedation procedure until the patient has returned to baseline mental status
measure: Patient Reported Pain and Recall of the Painful Procedure for Which They Were Sedated Measure by Patient Query After They Had Regained Their Baseline Level of Consciousness After the Procedure
timeFrame: single time point measured after sedation procedure completed
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin Faculty Associates
name: James R. Miner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Miner JR, Moore JC, Plummer D, Gray RO, Patel S, Ho JD. Randomized clinical trial of the effect of supplemental opioids in procedural sedation with propofol on serum catecholamines. Acad Emerg Med. 2013 Apr;20(4):330-7. doi: 10.1111/acem.12110.
Clinical trial NCT01014013: Safety and Tolerability of Ertapenem Sodium in the Treatment of Complicated Urinary Tract Infections (0826-055)
Official title: A Prospective, Multicenter, Partially-Blinded, Randomized, Comparative Study to Evaluate the Safety, Tolerability and Efficacy of INVANZ Versus Ceftriaxone Sodium in the Treatment of Complicated Urinary Tract Infections in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Tract Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-11-16
Enrollment: 271
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 purpose of this study is to determine the efficacy of ertapenem sodium (Invanz) in treatment of complicated urinary tract infections with respect to the proportion of patients with a favorable microbiological response at 5-9 days post therapy.


Eligibility criteria: Inclusion Criteria:

* Adult patients with a suspected or documented complicated urinary tract infection
* Female patients must test negative for pregnancy and agree to use adequate birth control measures
* Nursing women must agree to defer breastfeeding until 5 days after completion of all study antibiotic therapy

Exclusion Criteria:

* Patients with complete obstruction of any portion of the urinary tract
* Patients with rapidly progressive or terminal illness
* Renal transplant patients

Primary outcomes:
measure: Microbiological Response Assessment Profile
timeFrame: 5 to 9 days post-therapy
measure: The Number of Patients Who Experience Any Drug-related Adverse Experiences Leading to Discontinuation of Parenteral Study Drug and the Number of Patients With Any Drug-related Serious Adverse Experiences (AEs) During Parenteral Treatment
timeFrame: Adverse experiences that occurred during the study parenteral therapy period were analyzed. The period of parenteral therapy is from 3 days up to 14 days
Secondary outcomes:
measure: Clinical Response Assessment Profile
timeFrame: 5 to 9 days post-therapy
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Park DW, Peck KR, Chung MH, Lee JS, Park YS, Kim HY, Lee MS, Kim JY, Yeom JS, Kim MJ. Comparison of ertapenem and ceftriaxone therapy for acute pyelonephritis and other complicated urinary tract infections in Korean adults: a randomized, double-blind, multicenter trial. J Korean Med Sci. 2012 May;27(5):476-83. doi: 10.3346/jkms.2012.27.5.476. Epub 2012 Apr 25.
Clinical trial NCT02901613: Prophylactic Post-Cesarean Incisional Negative-pressure Wound Therapy in Morbidly Obese Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Negative-pressure Wound Therapy
Morbid Obesity
Cesarean Section
Wound Infection
Lead sponsor: Albany Medical College
Sponsor class: OTHER
First posted: 2016-09-15
Enrollment: 186
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the effectiveness of negative-pressure wound therapy in decreasing wound complications in morbidly obese patients (BMI greater than of equal to 40) at Albany Medical Center Hospital. Retrospective data will be collected regarding morbidly obese patients who have undergone cesarean section and patients will be recruited to have the intervention (negative-pressure wound therapy) applied and outcomes will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Women undergoing cesarean section at Albany Medical Center Hospital
* Current BMI greater than or equal to 40

Exclusion Criteria:

* Current BMI less than 40
* current skin or soft tissue infection
* skin or soft tissue disorder
* allergy to silver

Primary outcomes:
measure: Wound complication
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Albany
country: United States
facility: Albany Medical Center
state: New York
Study officials:
affiliation: Albany Medical College
name: Peter Cole, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03021213: Treating Heart Failure With Enhanced External Counterpulsation (EECP)
Official title: Treating Heart Failure With Enhanced External Counterpulsation (EECP): Prospective, Multi-centric Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Heart Failure
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with heart failure (NYHA II-IV)

* with optimal medical therapy
* arisen from ischemic or non-ischemic cardiomyopathy

Brief summary: Enhanced external counterpulsation (EECP) is an outpatient coronary artery disease (CAD) therapy that involves the cyclical inflation/deflation of cuffs wrapped around the lower extremities. However, the possible benefits of EECP in patients with heart failure (HF) (New York Heart Association \[NYHA\] classes II to IV) and cardiomyopathy are unclear.


Eligibility criteria: Inclusion Criteria:

* Patients with heart failure (NYHA II-IV)

  1. with optimal medical therapy
  2. caused by ischemic or non-ischemic cardiomyopathy
* EECP-Therapy and Treatment in the Cardio Centrum Berlin or Charité - University Medicine Berlin
* Aged 18 to 100 years
* Offered patient information and written informed consent

Exclusion Criteria:

* Participation in another interventional trial
* Acute coronary syndrome \< 4 weeks prior to enrollment
* Operation \< 4 weeks prior to enrollment
* Stroke \< 4 weeks prior to enrollment
* Clinically significant disease with hospitalization
* Aortic valvular heart disease ≥ moderate
* Aortic aneurysm
* clinically relevant severe cardiopulmonal diseases
* Resting RR \> 160/90mmHg
* Thrombose, Thrombophlebitis \< 8 weeks prior to enrollment
* Peripheral artery occlusive disease ≥ Stadium II
* Acute Heart failure
* Pathological bleeding tendency
* Arrhythmias, which interfere with Triggering of the EECP
* Other diseases, that inhibit EECP-Treatment (e.g. Spinal disc herniation)
* Accommodation in an institution due to an official or judicial order
* Women: pregnancy or lactation

Primary outcomes:
measure: Systolic and diastolic heart function
timeFrame: A period of 1 year
Secondary outcomes:
measure: Ergometric power increase
timeFrame: A period of 1 year
measure: Subjective health Status - Mental Health Composite Score
timeFrame: A period of 1 year
measure: Subjective health Status - Physical Health Composite Score
timeFrame: A period of 1 year
measure: Organ complications
timeFrame: A period of 1 year
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References: