louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01260987: Fractional CO2 Laser Assisted Photodynamic Therapy
Official title: Conventional Versus Fractional CO2 Laser Assisted Photodynamic Therapy for Basal Call Carcinomas and Actinic Keratoses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Actinic Keratosis
Basal Cell Carcinoma
Keywords: Moderate to severe actinic keratoses
Difficult to treat nodular basal cell carcinomas
Lead sponsor: Bispebjerg Hospital
Sponsor class: OTHER
First posted: 2010-12-16
Enrollment: 47
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: Nodular Basal Cell Carcinomas:

Compare the efficacy and safety of conventional versus fractional laser assisted PDT for difficult to treat nodular cell carcinomas in the face.

Actinic keratosis:

Compare the efficacy and safety of conventional versus fractional laser assisted PDT for moderate to severe actinic keratoses located in the face and on the hands.


Eligibility criteria: Inclusion Criteria:

* Age 18 or older
* Skin type I-III
* Fertile women using secure birth control
* Moderate to severe actinic keratoses in the face or on the hands,
* Difficult to treat nodular basal cell carcinomas in the face

Exclusion Criteria:

* Pregnancy or breast feeding patients
* Patients with porphyria
* Patients with Gorlins syndrome
* Patients with a tendency to produce hypertrophic scars or keloids
* Patients with known allergy to Metvix
* Patients who are not considered able to follow the treatment protocol (e.g. severely alcoholic, dementia, mentally ill etc.)
* Patients with pigmented or morphea basal cell carcinomas
* Know herpes simplex virus infection in treatment areas

Primary outcomes:
measure: Treatment response
timeFrame: 3 months
measure: Reoccurrence
timeFrame: 12 months
measure: Treatment response
timeFrame: 12 months
Secondary outcomes:
measure: Pain
timeFrame: during laser and PDT
measure: Adverse effects
timeFrame: 12 months
measure: Fluorescence
timeFrame: 3 hours
measure: Cosmetic result
timeFrame: 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Dermatology, Bispebjerg Hospital
Study officials:
affiliation: Bispebjerg Hospital
name: Merete Hædersdal, PhD,DrMedSci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00855387: Severe Complications Triplicate the Costs of Major Surgical Procedures
Official title: Surgical Complications Dramatically Influence Overall Cost of Major Surgical Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Major Surgical Procedures
Keywords: Clinical outcome (complications), in-hospital costs
The influence and impact of postoperative complications on in-hospital costs
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2009-03-04
Enrollment: 1235
Sex: ALL
Minimum age (years): 12
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A cohort study with 1235 patients including consecutive patients undergoing major surgery (liver, bile duct, pancreas, colorectal, gastric bypass and small bowel resections) in a single tertiary care center

Brief summary: The purpose of this study is to prospectively assess the impact of surgical quality on the overall cost of major surgical procedures using the incidence and severity of complications as surrogate markers of quality.

Detailed description: To prospectively assess the impact of surgical quality on the overall cost of major surgical procedures using the incidence and severity of complications as surrogate markers of quality

Eligibility criteria: Inclusion Criteria:

* Undergoing major surgery (liver, bile duct, pancreas, colorectal, gastric bypass and small bowel resections)

Exclusion Criteria:

* Missing data of in-hospital costs
* Mortality

Primary outcomes:
measure: Clinical outcome (complications) In-hospital Costs
timeFrame: inhospital; peri-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital of Zurich, Department of Visceral and Transplantation Surgery
Study officials:
affiliation: Department of Visceral and Transplantation Surgery
name: René Vonlanthen, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vonlanthen R, Slankamenac K, Breitenstein S, Puhan MA, Muller MK, Hahnloser D, Hauri D, Graf R, Clavien PA. The impact of complications on costs of major surgical procedures: a cost analysis of 1200 patients. Ann Surg. 2011 Dec;254(6):907-13. doi: 10.1097/SLA.0b013e31821d4a43.
Clinical trial NCT03777787: Bitter Tastants and Reflux
Official title: The Relationship Between Acute Administration of a Bitter Compound and Transient Lower Esophageal Sphincter Relaxations and Reflux Events in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro Esophageal Reflux
Keywords: Bitter
TLESRs
Gastric tone
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized, double-blind, placebo-controlled study
Primary purpose: OTHER

Brief summary: Recently the relationship between intragastric pressure (IGP) and reflux events after a meal was investigated, both in gastro-esophageal reflux disease (GERD) patients and in healthy volunteers. Ingestion of a meal was accompanied by a drop in IGP. However, the magnitude of this drop varied and was inversely correlated with the number of transient lower esophageal sphincter relaxations (TLESRs) and the number of reflux events, both in patients and in healthy volunteers: a smaller meal-induced drop in IGP was associated with a higher rate of reflux events and vice versa. This finding suggests that a smaller meal-induced drop may act as a trigger for reflux. It has been demonstrated that bitter administration leads to a smaller meal-induced drop. Therefore, bitter can be a dietary trigger for TLESRs facilitating the occurrence of symptoms of GERD. To evaluate this hypothesis, the researchers will study the relationship between bitter and the occurrence of TLESRs and reflux events in healthy volunteers. Additionally, it has been demonstrated that administering bitter also influences the concentration of motilin. Therefore, the research team will also measure the concentration of motilin to investigate whether changes in motilin concentrations can influence the number of TLESRs, via a change in gastric tone.


Eligibility criteria: Inclusion Criteria:

* Healthy female volunteers
* Age between 18 and 65
* Written informed consent

Exclusion Criteria:

* A history of any upper GI symptoms or GI surgery;
* Psychological disorders;
* Concomitant use of other medication or treatments except for oral contraceptives;
* Use of medication altering esophageal or GI motility;
* Pregnant or nursing women.

Primary outcomes:
measure: Change in number of TLESRs
timeFrame: 1 week
Secondary outcomes:
measure: Change in reflux
timeFrame: 1 week
measure: Change in motility pattern
timeFrame: 1 week
measure: Change in motilin concentration
timeFrame: 1 week
measure: Change in symptoms
timeFrame: 1 week
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: UZ Leuven
Study officials:
References:
Clinical trial NCT01402687: SNP-Based Prediction of Oral Mucositis Risk in Patients Receiving Hematopoietic Stem Cell Transplants (HSCT)
Official title: Single Nucleotide Polymorphism (SNP)-Based Prediction of Oral Mucositis Risk in Patients Receiving Hematopoietic Stem Cell Transplants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hodgkin's Lymphoma
Non-Hodgkin's Lymphoma
Multiple Myeloma
Keywords: Stem Cell Transplant
Mucositis
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2011-07-26
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have undergone autologous HSCT for Hodgkin's or non-Hodgkin's lymphoma or multiple myeloma at Dana Farber Cancer Institute from 1/1/2006 through 6/30/2010.

Brief summary: The goal of this study is to gain new knowledge about genetic risk factors thta may affect the development of mucositis, the chemotherapy-induced sores in the mouth and esophagus following HSCT. The study seeks to understand if different forms of genes result in an increased risk of sores in the mouth and esophagus.

Detailed description: Subjects will be provided with a saliva collection kit which can be used at home. Subjects will return the collection kit in a paid, pre-addressed mailer to the laboratory at Biomodels. The laboratory will isolate and store the DNA located in the cells of the saliva. A portion of this DNA will be used to analyze the different forms of genes. The remainder of the DNA will be destroyed when this study is completed. Biomodels will not be provided with patient identifiers.

The investigators will also collect information from medical records, including information about diagnosis, treatment, stem cell transplantation and post-transplantation outcomes. This information will be de-identified.

Eligibility criteria: Inclusion Criteria:

* Have given informed consent to submit a sample of saliva for DNA isolation and SNP analysis
* Have undergone autologous HSCT for treatment of Hodgkin's or non-Hodgkin's lymphoma or multiple myeloma at the Dana-Farber Cancer Institute from 1/1/2006 through 6/30/2010
* Have medical records identifying whether the participants did or did not develop severe mucositis

Exclusion Criteria:

* Received Palifermin (Kepivance) prior to their conditioning regimen

Primary outcomes:
measure: Develop and validate a clinically applicable SNP-based screening platform for mucositis risk
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Joseph Antin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01345487: Effect of Protein From Animal and Vegetable Sources on Appetite
Official title: Effect of Protein From Animal and Vegetable Sources on Appetite
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Focus of Study: Appetite
Keywords: appetite
protein
legumes
meat
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2011-05-02
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: New Nordic diet guidelines advocate a reduction in consumption of protein from animal sources such as beef and pork, due to environmental concerns. Instead, intake of protein from vegetable sources such as legumes and pulses should be increased. However, little is known about the effect of protein from (Nordic grown) beans and peas on body weight and appetite regulation.

The objective of this study is to examine if protein from vegetable sources (beans and peas) is comparable to protein from animal sources regarding acute meal-induced satiety.

Detailed description: Design:

Single-blind randomized 3-way crossover meal study

Subjects:

* 48 young healthy men (Age: 18-50 years; BMI: 19-30 kg/m2).
* Expected completers: n=42.

End points:

* Subjective appetite (VAS) (every 30 min for 3 hours)
* Ad libitum energy intake (3 hours after test meal)

Experimental diets:

Iso-caloric breakfast meals (3.5 MJ) with same energy density:

A. Fava beans + Split peas (20 protein E%) B. Fava beans + Split peas + potato (10 protein E%) C. Pork/beef + potato (20 protein E%)

Eligibility criteria: Inclusion Criteria:

* healthy men
* 18-50 y
* body mass index (BMI) 18.5-30.0

Exclusion Criteria:

* smoking
* participation in other studies for 4 mo prior to entry
* weight gain/loss \> 3 kg for to mo prior to entry
* Strenuous physical activity for \> 10 h/wk
* Use of medication that can affect appetite
* food allergies or relevance for the test meals
* Psychiatric or metabolic disorders prohibiting participation

Primary outcomes:
measure: Composite appetite score area under the curve (180 min)
timeFrame: Assessed every 30 min for 180 min after each of the three test meals which are served 1 wk apart
measure: Ad libitum energy intake
timeFrame: Assessed 180 min after each of the 3 test meals, which are served 1 wk apart
Secondary outcomes:
measure: Appetite ratings
timeFrame: Assessed every 30 min for 180 min after each or the 3 test meals which are served 1 wk apart
Other outcomes:
Locations:
city: Frederiksberg C
country: Denmark
facility: Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Study officials:
affiliation: University of Copenhagen
name: Arne Astrup, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01665287: Cerebral Oximetry in Newborns - Comparing INVOS 5100 and FORE-SIGHT Cerebral Oximeters
Official title: Cerebral Oximetry in Newborns - Comparing INVOS 5100 and FORE-SIGHT Cerebral Oximeters Absolute Values, Sensitivity for Low Oxygen Levels and Reproducibility..
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Near Infrared Spectroscopy
Keywords: Cerebral Oximetry
Near infrared spectroscopy
Fullterm
Infant
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: The Augustinus Foundation, Denmark.
First posted: 2012-08-15
Enrollment: 12
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Term infants born by elective cesarian section.

Brief summary: Regional tissue oxygenation (rStO2) can be monitored by near infrared spectroscopy. The commercial devices FORE-SIGHT (CASMED) and INVOS (COVIDIEN) will be used simultaneously to test for their relative sensitivity for low oxygen levels just after birth on term infants born by elective cesarean section. Reproducibility will be examined by replacements of the sensors six times the next day when the infant is stable and quiet. Neonatal sensors will be used.


Eligibility criteria: Inclusion Criteria:

* Term infants (age more than 37 weeks of gestation)
* Elective cesarean section after an uncomplicated pregnancy

Exclusion criteria:

* Thick hair that makes good measurements difficult/impossible
* Obvious malformations or syndrome
* Complications in relation to the cesarean section
* Depression after birth (APGAR \< 8 after 1 minute)

Primary outcomes:
measure: Cerebral oxygenation
timeFrame: 10 minutes
Secondary outcomes:
measure: Reproducibility
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Neonatology, Rigshospitalet
Study officials:
affiliation: Not relevant
name: Gorm Greisen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Noori S, Wlodaver A, Gottipati V, McCoy M, Schultz D, Escobedo M. Transitional changes in cardiac and cerebral hemodynamics in term neonates at birth. J Pediatr. 2012 Jun;160(6):943-8. doi: 10.1016/j.jpeds.2011.12.008. Epub 2012 Jan 11.
citation: Kratky E, Pichler G, Rehak T, Avian A, Pocivalnik M, Muller W, Urlesberger B. Regional cerebral oxygen saturation in newborn infants in the first 15 min of life after vaginal delivery. Physiol Meas. 2012 Jan;33(1):95-102. doi: 10.1088/0967-3334/33/1/95.
citation: Urlesberger B, Kratky E, Rehak T, Pocivalnik M, Avian A, Czihak J, Muller W, Pichler G. Regional oxygen saturation of the brain during birth transition of term infants: comparison between elective cesarean and vaginal deliveries. J Pediatr. 2011 Sep;159(3):404-8. doi: 10.1016/j.jpeds.2011.02.030. Epub 2011 Apr 9.
citation: Urlesberger B, Grossauer K, Pocivalnik M, Avian A, Muller W, Pichler G. Regional oxygen saturation of the brain and peripheral tissue during birth transition of term infants. J Pediatr. 2010 Nov;157(5):740-4. doi: 10.1016/j.jpeds.2010.05.013. Epub 2010 Jun 17.
Clinical trial NCT03179787: Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism
Official title: Post-Marketing Surveillance Study of Aripiprazole in Patients With Autism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-06-07
Enrollment: 528
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: naive patients with aripiprasole

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of aripiprazole in patients with autism in the real world clinical setting in Japan.


Eligibility criteria: Inclusion Criteria:

* diagnosed as autism with irritability

Exclusion Criteria:

* patients who has ever been treated with aripiprazole

Primary outcomes:
measure: Mean Changes of Aberrant Behavior Checklist-Japanese Version (ABC-J) Irritability Subscale Scores From Baseline.
timeFrame: Baseline, Week 4, 8, 16, 24, 52
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Otsuka Pharmaceutical Co., Ltd.
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Pharmacovigilance
role: STUDY_DIRECTOR
References:
citation: Sugimoto Y, Yamamura K, Takayama T, Fukuta Y, Aoki K, Mikami K, Tomoda A. Aripiprazole in the real-world treatment for irritability associated with autism spectrum disorder in children and adolescents in Japan: 52-week post-marketing surveillance. BMC Psychiatry. 2021 Apr 22;21(1):204. doi: 10.1186/s12888-021-03201-6.
Clinical trial NCT04768387: The Effect of AI-based Microbiome Diet on IBS-M Symptoms
Official title: An Open-labelled Interventional Study With 25 IBS-M Patients in Which Group 1 (n=14) Followed Six Weeks of AI-based Microbiome Diet and Group 2 (n=11) Followed Standard IBS Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome Mixed
Lead sponsor: Gazi University
Sponsor class: OTHER
Collaborators: name: Enbiosis Biotechnology
name: TC Erciyes University
First posted: 2021-02-24
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was designed as a pilot, open-labelled study. We enrolled consecutive IBS-M patients (n=25, 19 females, 46.06 ± 13.11 years) according to Rome IV criteria. Fecal samples were obtained from all patients twice (pre- and post-intervention) and high-throughput 16S rRNA sequencing was performed. Patients were divided into two groups based on age, gender and microbiome matched.

Six weeks of AI-based microbiome diet (n=14) for group 1 and standard IBS diet (Control group, n=11) for group 2 were followed. AI-based diet was designed based on optimizing a personalized nutritional strategy by an algorithm regarding individual gut microbiome features. An algorithm assessing an IBS index score using microbiome composition attempted to design the optimized diets based on modulating microbiome towards the healthy scores. Baseline and post-intervention IBS-SSS (symptom severity scale) scores and fecal microbiome analyses were compared.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with IBS by a medical doctor.
* BMI between 18.5-39.9 kg/m2
* No hospitalization in the last 12 months.
* No antibiotics use in the last 6 months.
* No cancer diagnosis by a medical doctor.
* No chronic complex diseases including diabetes and hypertension.

Exclusion Criteria:

* Not being diagnosed with IBS.
* Having a diagnosed chronic disease.
* Having a diagnosed mental or psychiatric disorder .
* Having endocrinal disorders.
* Being pregnant.
* Antibiotics use in the last 6 months.
* Hospitalization history in the last 12 months.
* Drug use.
* Being morbid obese.

Primary outcomes:
measure: IBS-SSS change
timeFrame: Change is measured between the scores pre-intervention and the scores six weeks after the intervention starts
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gazi University
Study officials:
References:
Clinical trial NCT01349387: Effect of Treatment With Metformin in Type 2 Diabetes Patients on Alternative Genes Splicing
Official title: Effect of Treatment With Metformin in Type 2 Diabetes Patients on Alternative Genes Splicing Whose Maturation Depends on the Protein HuR, Including Gene Encoding Insulin Receptor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Sponsor class: OTHER
First posted: 2011-05-06
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Main objective : Show that treatment with metformin in patients with type 2 diabetes has an effect on alternative splicing of the insulin receptor.

Secondary objective : demonstrate that the effect on the ratio A/isoform B isoform with discontinuation of treatment with metformin can be réversé by the resumption of metformin treatment.


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetic patients usually treated with metformin (≥ 1400 mg/day), associated or not to other oral anti-diabetic treatment or. injection treatment
* Patients major.
* Patients with a social security number
* Patients having signed a consent to participate in the study

Exclusion Criteria:

* Intolerance metformin
* Patients with type 1.
* Patients on pioglitazone or rosiglitazone
* Renal failure by an anomaly of the creatinine clearance (\< 60 mL/min).
* Patients pregnant or likely to be.

Primary outcomes:
measure: Comparison of expression of isoforms A and B of the insulin receptor using quantitative RT PCR
timeFrame: inclusion (baseline), 30th days and 60th days
Secondary outcomes:
Other outcomes:
Locations:
city: Corbeil Essonnes
country: France
facility: Centre Hospitalier Sud Francilien
Study officials:
affiliation: CHSF-CERITD
name: Guillaume CHARPENTIER, MD
role: PRINCIPAL_INVESTIGATOR
References: