louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04575701: Long-term Outcome of TNF Alpha Therapy in IBD
Official title: Long-term Outcome of TNF Alpha Therapy in IBD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: IBD
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2020-10-05
Enrollment: 538
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study Population includes all patients with a confirmed IBD diagnosis who have been treated with an TNF Alpha antibody in the last 20 years at our outpatient clinic in Graz, Austria

Brief summary: The aim of this retrospective study is to assess the outcome of patients with inflammatory bowel disease (IBD) under TNF-alpha antibody therapy over a period of 20 years

Detailed description: Long-term results published so far show that over the years a large part of patients have to stop TNF Alpha antibody therapy in IBD. Reasons are mostly loss of effectiveness or intolerance or side effects. Reasons for the termination are usually poorly characterized with regard to the exact reason and time. As a consequence, the aim of this retrospective study is to assess the outcome of patients with inflammatory bowel disease under TNF-alpha antibody therapy over a period of 20 years

Eligibility criteria: Inclusion Criteria:

* Patients with a confirmed IBD diagnosis
* TNF Alpha antibody therapy in the last 20 years at our outpatient clinic

Exclusion Criteria:

* Not Meeting the inclusion criteria
* Lack of clinical data, no follow up available

Primary outcomes:
measure: Length of first TNF Alpha Therapy in IBD patients
timeFrame: 20 years
Secondary outcomes:
measure: Rate of further biologicals after first TNF Alpha therapy
timeFrame: 20 years
measure: Rate of surgical interventions after first TNF Alpha
timeFrame: 20 years
measure: Reasons for discontinuing therapy
timeFrame: 20 years
measure: Predictive factors
timeFrame: 20 years
measure: Number of side effects
timeFrame: 20 years
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
affiliation: Meduni Graz
name: Wolfgang Petritsch, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05866601: Effects on Anxiety in Physiotherapy Students After Simulation as an Active Method for Learning the Clinical Enterview
Official title: Effects on Anxiety in Physiotherapy Students After Simulation With Kirkpatric Evaluation as an Active Method for Learning the Clinical Enterview
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clinical Interview
Keywords: Medical education
nursing education
physiotherapy
empathy
anxiety
Lead sponsor: Mayuben Private Clinic
Sponsor class: OTHER
First posted: 2023-05-19
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: First year physiotherapy students who carry out the role playing of the clinical history.

Brief summary: The aim of the main study is to find out the effects on anxiety in physiotherapy students after role playing in the learning of the clinical history.

Detailed description: Thirty-one first-year physiotherapy students will carry out the role-playing methodology to learn how to take a clinical history in physiotherapy.

Before and after the realization, they will be measured by means of a validated questionnaire in Spanish, the language in which they study, the variable of anxiety.

Eligibility criteria: Inclusion Criteria:

* Men and women who are studying the first year of Physiotherapy at the Complutense University of Madrid and wish to participate in the study.

Exclusion Criteria:

* Students who do not wish to participate in the study.

Primary outcomes:
measure: Anxiety Questionnaire called STAI before role playing
timeFrame: Through study completion, an average of 12 days
measure: Anxiety Questionnaire called STAI after role playing
timeFrame: Through study completion, an average of 12 days
measure: Jefferson scale before role playing
timeFrame: Through study completion, an average of 12 days
measure: Jefferson scale after role playing
timeFrame: Through study completion, an average of 12 days
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid.
country: Spain
facility: Eva María Martínez-Jiménez
state: Madrid
city: Madrid
country: Spain
facility: Universidad Complutense de Madrid
Study officials:
References:
Clinical trial NCT01750801: Efficacy of a Mouthwash Containing Propolis
Official title: Clinical Evidence Efficacy of a Mouthwash Containing Propolis for the Control of Plaque and Gingivitis: Phase III, Randomized, Double-blind Comparison With Mouthwash Chlorhexidine Base.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Gingivitis
Periodontitis
Plaque
Inflammation
Keywords: clinical trial
mouthwash
propolis
plaque
gingivitis
compliance
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Characterization of green propolis and development of mouthwash containing propolis to control plaque and gingivitis. A Phase I.

Detailed description: Chemical characterization of propolis by HPLC (High-performance liquid chromatography), antimicrobial testing against pathogens and cariogenic. Studies in vitro on anti-inflammatory activity, cytotoxicity tests of green propolis.

Eligibility criteria: Inclusion Criteria:

* age ranging from 18 to 60 years
* minimum of 20 natural teeth
* mean plaque index (PI)of at least 1.5
* an average gingival index (GI), at least less than 1.0.

Exclusion Criteria:

* Individuals with orthodontic appliances or removable dentures,
* Individuals whit tumors of soft tissue or hard mouth, and advanced periodontal disease,
* Indivuduals whit antibiotic therapy 2 weeks prior to study initiation, or with known hypersensitivity propolis are also excluded.

Primary outcomes:
measure: Chemical characterization of propolis by HPLC (High-performance liquid chromatography)
timeFrame: 8-12 weeks
Secondary outcomes:
measure: PRELIMINARY EVIDENCE OF THE EFFICACY OF A MOUTHWASH CONTAINING 5% PROPOLIS FOR THE CONTROL OF PLAQUE AND GINGIVITIS
timeFrame: 90 days
Other outcomes:
Locations:
city: Belo horizonte
country: Brazil
facility: Federal University of Minas Gerais
state: MG
Study officials:
affiliation: UFMG
name: andre oliveira naufel de toledo 35893/MG
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02231801: Monitoring of Vital Signs During Skin-to-skin Holding by Mothers of Their Preterm Babies
Official title: Vital Sign Monitoring of Mother-Infant Dyads During Kangaroo Care in Preterm Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Other Preterm Infants
Keywords: Preterm
Kangaroo Care
Skin-to-Skin
Vital Sign
Heart Rate
Respiratory Rate
Oxygen Saturation
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2014-09-04
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants born at Mt. Sinai Hospital and admitted to the NICU. Preterm infants between 30 0/7 weeks gestational age to 34 6/7 weeks gestation age.

Brief summary: This observational study aims to monitor the vital sign changes in both mother and baby that occur during kangaroo care in preterm infants and to investigate any potential correlations between maternal measurement values and those of the infant. The purpose of this observational study is to look for a method to track the earliest responses that could, theoretically, be considered as 'social responses' in hopes of providing developmental interventions earlier to at-risk infants.

Detailed description: The goal of this observational study is to identify any signs of early "social response" in order to be able to assist infants that lack this response with early neurobehavioral modifications.

Eligibility criteria: Inclusion Criteria:

* inborn at Mount Sinai
* gestational age between 30 0/7 weeks and 34 6/7 weeks gestation
* only one infant of a multiple gestation
* plan by family to do kangaroo care during NICU stay

Exclusion Criteria:

* outborn infants
* gestational age less that 29 6/7 weeks or greater than 35 0/7 weeks
* other infants of multiple gestation (see inclusion criteria)
* any major congenital anomalies
* sepsis and/or any other serious clinical complication precluding kangaroo care

Primary outcomes:
measure: Heart Rate
timeFrame: up to 30 minutes
Secondary outcomes:
measure: Respiratory Rate
timeFrame: up to 30 minutes
measure: Oxygen Saturation
timeFrame: up to 30 minutes
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Ian Holzman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00569101: A Pilot Study for the Efficacy and Safety of Tacrolimus in the Treatment of Refractory Lupus Nephritis
Official title: A Pilot Study for the Efficacy and Safety of Tacrolimus in the Treatment of Refractory Lupus Nephritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lupus Nephritis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2007-12-06
Enrollment: 9
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 protocol is to determine whether Tacrolimus and Prednisolone are effective and safe in the treatment of the cyclophosphamide-resistant, refractory diffuse proliferative lupus nephritis


Eligibility criteria: Inclusion Criteria:

* Biopsy-proven lupus nephritis WHO Class IV , IV+V
* Previously treated by three times over of i.v. cyclophosphamide or 6 months more duration of immunosuppressive treatments (azathioprine, MMF, cyclophosphamide p.o.) for the lupus nephritis
* spot urine Protein creatinine raio \> 1.0
* RBC \> 5 /HPF on microscopic examination of urine

Exclusion Criteria:

* previous treatment of cyclosporine A or tacrolimus
* serum Creatinine lever : over 300 mmol/dl
* allergy to the macrolide antibiotics
* other systemic organ damage

Primary outcomes:
measure: Reducing proteinuria
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SeoulNUH
state: Chongno-gu
Study officials:
affiliation: Korea : Seoul National University Hospital
name: Suhnggwon Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05836701: Retrospective Study of Germ Cell Tumors of the Central Nervous System
Official title: Single-center Retrospective Study of Germ Cell Tumors of the Central Nervous System
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Germ Cell Tumor of CNS
Lead sponsor: Beijing Sanbo Brain Hospital
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Sanbo Brain Hospital, Capital Medical University

Brief summary: Retrospectively analyzing the epidemiological and clinical characteristics, treatment, recurrence, prognosis and prognostic factors of the germ-cell tumors of central nervous system in a single center.

Detailed description: Clinical data of patients with germ-cell tumors of central nervous system who were treated in the Department of Neuro-oncology, Sanbo Brain Hospital Capital Medical University between January 2007 and December 2022 were retrospectively collected, and the epidemiological and clinical characteristics, treatment, recurrence, prognosis and prognostic factors of the disease were analyzed.

Eligibility criteria: Inclusion Criteria:

* Clinically or pathologically diagnosed as germ cell tumor of the central nervous system.
* Have received antitumor therapy.
* Patients who were clinically diagnosed based on neuroimaging characteristics and response to radiotherapy or chemotherapy were allowed for enrollment.

Exclusion Criteria:

* Patients with missing key information such as tumor location, surgical, chemotherapy and radiotherapy data, and post-treatment evaluation.

Primary outcomes:
measure: epidemiological characteristics
timeFrame: 1 year
measure: treatment regimen
timeFrame: 1 year
measure: relapse pattern
timeFrame: 1 year
measure: prognostic factor
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Sanbo Brain Hospital Capital Medical University
Study officials:
affiliation: Capital Medical University
name: Jun-ping Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01533701: Scalp Sampling for Fetal Surveillance
Official title: Biosampling for Markers of Hypoxia in Fetal Blood Scalp Sampling During Labor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fetal Hypoxia
Keywords: Hypoxia
Fetal blood sampling
Lactate
pH
base deficit
angiogenic factors
suspected fetal hypoxia
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
Collaborators: name: Uppsala County Council, Sweden
First posted: 2012-02-15
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to compare lactate and total acid-base status in fetal scalp blood with lactate and total acid-base status in maternal blood and amniotic fluids to provide information on how lactate and base deficit correlates with scalp samples.

Furthermore, the investigators want to study whether angiogenic factors in fluids above may be a possible marker of asphyxia during labor.


Eligibility criteria: Inclusion Criteria:

* All deliveries eligible for fetal blood sampling

Exclusion Criteria:

* Non Swedish speaking
* Those who decline to participate in the study

Primary outcomes:
measure: Hypoxia
timeFrame: 120 seconds
Secondary outcomes:
measure: Subacute hypoxia
timeFrame: 120 seconds
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Delivery department Uppsala University hospital
Study officials:
References:
Clinical trial NCT02276001: Drug-Drug Interaction Study in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Adult Volunteers
Lead sponsor: Kowa Research Institute, Inc.
Sponsor class: INDUSTRY
First posted: 2014-10-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: The primary objective of this study is to assess the effects of cyclosporine on the pharmacokinetics of K-877 in healthy adult subjects.


Eligibility criteria: Inclusion Criteria:

* Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening.
* Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening.
* Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges or is showing no clinically relevant deviations, as judged by the investigator at Screening.

Exclusion Criteria:

* Subject has clinically relevant abnormalities in the screening or check in assessments.
* Subject has a blood pressure (as measured at Screening during the collection of vital signs) after resting supine for at least 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic (for males) and 50 mm Hg diastolic (for females).
* Subject has a supine pulse rate (as measured at Screening during collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute.

Primary outcomes:
measure: Maximum concentration (Cmax)
timeFrame: 72 hours
Secondary outcomes:
measure: Area under concentration curve (AUC)
timeFrame: 72 hours
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD
state: Texas
Study officials:
affiliation: Kowa Research Institute, Inc.
name: Stuart Campbell
role: STUDY_DIRECTOR
References:
Clinical trial NCT03869801: Comparion of Erector Spinae Plane Block and Quadratus Lumborum Block in Laparoskopic Cholecystectomy
Official title: Comparison of Ultrasound Guided Bilateral Erector Spinae Plane Block and Quadratus Lumborum Block in Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Anesthesia, Local
Lead sponsor: Maltepe University
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that erector spinae plane block could be efficacious for providing postoperative analgesia in laparoscopic cholecystectomy, the investigators have implemented the application of this blockade into practice at the clinic.Quadratus Lumborum block (QLB) type 2 is another regional anesthesia technic used for postoperative analgesia in laparoscopic cholecystectomy. Main purpose of this study is to compare the analgesic effect of ultrasound-guided erector spinae block and QLB in laparoscopic cholecystectomy.


Eligibility criteria: Inclusion Criteria:

* Elective laparoscopic Cholecystectomy, ASA status 1-2

Exclusion Criteria:

* Patient refusal Contraindications to regional anesthesia Known allergy to local anesthetics Bleeding diathesis Use of any anti-coagulants Inability to provide informed consent Severe kidney or liver disease Inability to operate PCA system Patient with psychiatric disorders

Primary outcomes:
measure: analgesic consumption
timeFrame: 24 hours
Secondary outcomes:
measure: NRS scores
timeFrame: 24 hours
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya research hospital
city: Istanbul
country: Turkey
facility: Maltepe University faculty of medicine
city: İzmir
country: Turkey
facility: Cigli Educatinal Hospital
Study officials:
References:
citation: Okmen K, Metin Okmen B, Topal S. Ultrasound-guided posterior quadratus lumborum block for postoperative pain after laparoscopic cholecystectomy: A randomized controlled double blind study. J Clin Anesth. 2018 Sep;49:112-117. doi: 10.1016/j.jclinane.2018.06.027. Epub 2018 Jun 18.
citation: Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.
Clinical trial NCT00111501: LGBT Internet Based Smoking Treatment - 1
Official title: LGBT Internet Based Smoking Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Tobacco Use Disorder
Keywords: smoking
tobacco
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-05-23
Enrollment: 792
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The overall goals of this line of research are to develop and evaluate innovative treatments for lesbian, gay, bisexual, and transgender (LGBT) cigarette smokers and to understand the processes related to smoking and relapse in this previously unstudied population of smokers. In this study, participants are randomly assigned to one of two Internet-based smoking cessation treatments: 1) a self-help intervention tailored LGBT smokers plus social support plus email-based counseling, or 2) a standard self-help condition alone, similar to other general smoking cessation treatments. Before starting the program, participants will complete measures of smoking, nicotine dependence, depression diagnosis, demographics, mood, motivation to change, and alcohol use. Smoking status will be determined at 1, 3, 6, and 12 months following the start of treatment. Data will be analyzed to compare the quit rates of the two Internet-based treatment groups. Also, we will complete exploratory analyses to determine those variables that best predict quitting for LGBT smokers.


Eligibility criteria: Must identify as a lesbian, gay male, bisexual male or female or a transgender individual. Must smoke most days during the preceding month. Must have a valid email address.

Primary outcomes:
measure: point-prevalence abstinence from tobacco use
timeFrame: 7-day
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco Medical Cen
state: California
Study officials:
affiliation: University of California, San Francisco
name: Gary Humfleet, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: