louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02476643: Integrative Gastroenterology - an Observational Trial
Official title: Integrative Therapy in Gastroenterology - a Prospective Observational Trial in a Department of Internal and Integrative Medicine
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohns Disease
Ulcerative Colitis
Irritable Bowel Syndrome
Lead sponsor: Universität Duisburg-Essen
Sponsor class: OTHER
First posted: 2015-06-19
Enrollment: 200
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: 100 patients with Inflammentory Bowel Disease admitted to the Department of Internal and Integrative Medicine.

100 patients with Irritable Bowel Syndrome admitted to the Department of Internal and Integrative Medicine.

Brief summary: This study aims to test, if a two-week integrative therapy in an internal medicine ward will improve symptoms, disability and quality of life in patients with inflammatory bowel disease or irritable bowel syndrome.a It shall further be tested, if those changes are associated with attitudes and experiences towards complementary and alternative medicine, anxiety, depression and stress perception as well as body awareness and responsiveness.

Detailed description: see above

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* diagnosed with Irritable Bowel Syndrome (IBS) or Inflammatory Bowel Disease (IBD)
* written informed consent

Exclusion Criteria:

* participation in other clinical studies

Primary outcomes:
measure: Symptoms Severity IBS-SSS
timeFrame: 2 weeks
measure: Symptoms Severity CAI
timeFrame: 2 weeks
measure: Symptoms Severity CDAI
timeFrame: 2 weeks
Secondary outcomes:
measure: Symptoms Severity IBS-SSS
timeFrame: 24 weeks
measure: Symptoms Severity CAI
timeFrame: 24 weeks
measure: Symptoms Severity CDAI
timeFrame: 24 weeks
measure: Disability MYMOP
timeFrame: 2 weeks
measure: Disability MYMOP
timeFrame: 24 weeks
measure: Quality of Life IBS-QOL
timeFrame: 2 weeks
measure: Quality of Life IBS-QOL
timeFrame: 24 weeks
measure: Quality of Life IBDQ
timeFrame: 2 weeks
measure: Quality of Life IBDQ
timeFrame: 24 weeks
measure: Self efficacy questionnaire SWE
timeFrame: 2 weeks
measure: Self efficacy questionnaire SWE
timeFrame: 24 weeks
measure: Body awareness BAQ
timeFrame: 24 weeks
measure: Body awareness BRS
timeFrame: 24 weeks
measure: Adverse effects
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Essen
country: Germany
facility: Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Study officials:
affiliation: Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
name: Gustav Dobos, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00992043: Creatine Supplementation and Diabetes
Official title: Efficacy and Safety of Creatine Supplementation Combined With Exercise Training in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Renal Function
Keywords: creatine supplementation
exercise training
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2009-10-08
Enrollment: 28
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Creatine supplementation is capable of improving glucose tolerance in healthy subjects. The researchers aim to investigate whether this supplement can affect metabolic control in diabetic patients.


Eligibility criteria: Inclusion Criteria:

* males and females type 2 diabetic patients
* glycated hemoglobin between \> 9%
* non insulin users
* physically inactive
* only metformin and/or sulfonylurea users
* BMI \> 30 kg/m2
* age of years \> 50 y

Primary outcomes:
measure: glycated hemoglobin
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: General Hospital - School of Medicine - University of Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Bruno Gualano, PhD ongoing
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gualano B, Lugaresi R, de Salles Painelli V, Queiroz AC, Artioli G, Roschel H, Otaduy MC, Leite Cda C, Lancha AH Jr. Creatine supplementation does not augment muscle carnosine content in type 2 diabetic patients. Appl Physiol Nutr Metab. 2011 Oct;36(5):764-7. doi: 10.1139/h11-083.
citation: Gualano B, de Salles Painelli V, Roschel H, Lugaresi R, Dorea E, Artioli GG, Lima FR, da Silva ME, Cunha MR, Seguro AC, Shimizu MH, Otaduy MC, Sapienza MT, da Costa Leite C, Bonfa E, Lancha Junior AH. Creatine supplementation does not impair kidney function in type 2 diabetic patients: a randomized, double-blind, placebo-controlled, clinical trial. Eur J Appl Physiol. 2011 May;111(5):749-56. doi: 10.1007/s00421-010-1676-3. Epub 2010 Oct 26.
Clinical trial NCT01807143: Genetic Biomarkers in Tissue Samples From Patients With Osteosarcoma
Official title: Observational - Gene Discovery in Osteosarcoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteosarcoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-03-08
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Osteosarcoma

Brief summary: This clinical trial studies genetic biomarkers in tissue samples from patients with osteosarcoma. Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer

Detailed description: Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Retrospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Samples from the COG Sampling Method: Non-Probability Sample

PRIMARY OBJECTIVES:

I. To use PET sequencing to analyze DNA from ten human primary osteosarcoma samples, along with matched normal tissue where available.

OUTLINE:

Tissue samples are analyzed for translocations and deletions and analyzed using polymerase chain reaction (PCR) or fluorescence in situ hybridization (FISH).

Eligibility criteria: Inclusion Criteria:

* Samples from the COG tissue repository

Primary outcomes:
measure: Mapping and filtering of paired tags
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Monrovia
country: United States
facility: Children's Oncology Group
state: California
Study officials:
affiliation: Children's Oncology Group
name: Richard Gorlick, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06323343: Mobile Video Education to Improve Patient Clinician Communication During Prenatal Clinic Visits
Official title: Mobile Video Education to Improve Patient Clinician Communication During Prenatal Clinic Visits
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Empowerment
Keywords: Prenatal care
Congenital abnormalities
Communication
Mobile health
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this clinical trial is to test an animated video delivered by text message in patients whose pregnancies are complicated with fetal anomalies. The main question it aims to answer is: Does the video intervention prepare parents to talk to the doctors during prenatal appointments?

Participants will be randomized to receive either the video intervention or links to the clinic's webpages. They will complete an enrollment survey before their appointment and a follow up survey after their appointment.

The researchers will compare the video and webpage groups to see which group reports engaging in more of the identified best-practices of communication.


Eligibility criteria: Inclusion Criteria:

* Pregnant patient scheduled for an appointment at the Children's Wisconsin Fetal Concerns Center for a fetal anomaly.
* Able to speak and understand English (intervention videos are only currently available in English).
* Age of 18 years or older.

Exclusion Criteria:

* Pregnant patient's appointment at Children's Wisconsin Fetal Concerns center is not for a fetal anomaly (e.g., screening only, past pregnancy with anomaly only cause of appointment)
* Pregnant patient is considering termination of pregnancy.

Primary outcomes:
measure: Parents' communication behaviors measure
timeFrame: Administered 1 day after appointment
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Fetal Concerns Center Children's Wisconsin
state: Wisconsin
Study officials:
References:
Clinical trial NCT01595243: Effects of Telephone Consultations on Discharged Liver Cancer
Official title: Effects of Telephone Follow- up Consultations on Discharged Liver Cancer Following Non-surgical Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Carcinoma
Keywords: hepatocellular carcinoma
Needs
Telephone consultation
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2012-05-10
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aims of this three-year study are to:

1. From patients and family perspective to explore the needs for home care after receiving TACE, PEI, and RFA
2. Develop a telephone follow-up and consultation program and examine its effect on self-efficacy, anxiety, depression and quality of life in liver cancer patients receiving non-surgical treatment.

Detailed description: In the first year, a longitudinal mixed method with quantitative and qualitative method will be used. The Distress Management Tool, the Hospital Anxiety and Depression Scale, and the Short Form-12 quality of life will be used to assess patients' care needs, anxiety, depression, and quality of life in the quantitative method. Data will be analyzed by descriptive, Pearson's Correlation, and Stepwise Regression for each time point. Tape-recorded and in-depth interviews with semi-structured interview guidelines will be used in qualitative method to interview the cancer patients who are scheduled to be discharged after treatment. Content analysis will be used to analyze the interview content.

In the second and third year, randomized control trial will be used to recruit eligible subjects from inpatients in oncology wards in one medical center in Taipei. The eligible subjects will be randomized into a control or experimental group. The patients in the control group will receive usual care and those in the experimental group will receive seven instances of telephone follow-up or face-to-face education (the day before discharge and during the first, second, third, fourth, sixth, and eighth weeks after discharge).Data will be analyzed by independent t-test, one-way analysis of variance, and generalized estimating equations.

Eligibility criteria: Inclusion Criteria:

* Patients with liver cancer in non-surgical treatment
* Aged above 18
* Those who are wiling to participate in the research

Exclusion Criteria:

* None

Primary outcomes:
measure: 12-Item Short Form Survey
timeFrame: 3 months after discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University
name: Shiow-ching shun, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01670643: Reading Performance With a Video Magnifier
Official title: The Effect of Video Camera Magnifier Use on Reading
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Degeneration
Keywords: AMD
vision rehabilitation
video camera magnifier
IVI
DASS
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2012-08-22
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy

Brief summary: The most common goal for patients with vision loss who present for vision rehabilitation is to be able to read. The video magnifier (a device which combines a video camera and a screen to view the print being magnified) is the device which most often allows low-vision individuals to read successfully for extended periods of time. Previous studies on the outcomes of vision rehabilitation have not identified which components of the vision rehabilitation are effective. The hypothesis of this project is that providing a video camera magnifier, with basic training in operating the device, will allow patients to enhance both objective reading ability and subjective report of reading competence.

Detailed description: Patients will be given a video magnifier at initial consultation or at the end of vision rehabilitation

Eligibility criteria: Inclusion Criteria:

* Central field loss and decreased visual acuity in the better seeing eye (\<20/40 \& \>20/400).
* New patient at MEEI Low Vision Rehabilitation Clinic

Exclusion Criteria:

* Dementia (Mini-Mental State Examination)
* Clinical depression (Geriatric Depression Scale)
* Patients who previously received vision rehabilitation
* Patients who have previously owned a desktop video magnifier

Primary outcomes:
measure: Change in objective reading performance
timeFrame: baseline and one month
Secondary outcomes:
measure: Change in subjective reading performance
timeFrame: baseline and one month
Other outcomes:
Locations:
city: Boston
country: United States
facility: Vision Rehabilitation Clinic Massachusetts Eye and Ear Infirmary
state: Massachusetts
Study officials:
affiliation: Vision Rehabilitation Center MEEI
name: Mary Lou Jackson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05051943: A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Official title: A Prospective Observational Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Crohn Disease
Ulcerative Colitis
Psoriasis
Ankylosing Spondylitis
Rheumatoid Arthritis
Psoriatic Arthritis
Keywords: nutrition
Lead sponsor: Fresenius Kabi
Sponsor class: INDUSTRY
First posted: 2021-09-21
Enrollment: 754
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: Adults patients with rhumatologic, gastrologic or dermatologic disease eligible to a treatment with adalimumab

Brief summary: The aim of the study is to describe the real-world profile of patients treated with adalimumab FK in gastroenterology, dermatology or rheumatology in order to evaluate in this population the predictive factors of therapeutic response (in particular nutritional status) and generate hypothesis between nutritional status and therapeutic response.


Eligibility criteria: Inclusion Criteria:

* Patients at least 18 years old who agree to participate in the study and do not object to the use of their health data
* A disorder treated with anti-TNF therapy
* Whose physician made the decision to initiate adalimumab treatment prior to the study

Exclusion Criteria:

* Patients participating in an interventional therapeutic trial at the time of inclusion
* Patients who are unwilling or unable to fulfil follow-up requirements (patients who cannot be reached by phone or complete the self-administered questionnaire or not fluent in French

Primary outcomes:
measure: Clinical Global Impression (CGI)
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: CHRU de Nancy - Hôpitaux de Brabois
Study officials:
affiliation: CHU NANCY
name: Laurent Peyrin-Biroulet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02912143: German Pediatric Hemophilia Research Database
Official title: German Pediatric Hemophilia Research Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hemophilia A
Hemophilia B
Children
Drug Specific Antibodies
Lead sponsor: Goethe University
Sponsor class: OTHER
Collaborators: name: Society for Thrombosis and Haemostasis Research (Germany)
First posted: 2016-09-23
Enrollment: 800
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All children between 0 and 18 yrs diagnosed with hemophilia A or B (FVIII/FIX \< 1% to 25%) from 01.01.2017.

Brief summary: The German Pediatric Hemophilia Research Database will collect data on the prophylactic and therapeutic use of factor concentrates, complications, outcome measures (joint scores, QoL) and living circumstances in newly diagnosed children with hemophilia.


Eligibility criteria: Inclusion Criteria:

* hemophilia A or B
* FVIII/FIX \<1% to 25%
* informed consent

Exclusion Criteria:

* no consent

Primary outcomes:
measure: Number of patients with antibody developement to exogenous clotting factors (>0.5 BU)
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Goethe University
state: Hesse
Study officials:
affiliation: Goethe University
name: Christoph Königs, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03658343: T2* MRI Analysis for Sarcoma
Official title: An Exploratory, Pilot Study Evaluating T2* Imaging for Adult Sarcoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiotherapy
Magnetic Resonance Imaging
Sarcoma
Keywords: soft tissue sarcoma
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Holden Comprehensive Cancer Center
name: National Cancer Institute (NCI)
First posted: 2018-09-05
Enrollment: 8
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 pathologically confirmed sarcoma that have been recommended for standard of care radiation therapy

Brief summary: T2\* imaging is a method to identify labile iron pools in tumor cells. These iron pools may be linked to better treatment outcomes for specific types of therapy. This is a small pilot study to see if radiation therapy changes the amount of iron in a sarcoma tumor.


Eligibility criteria: Inclusion Criteria:

* pathologically confirmed Sarcoma, by biopsy or excision
* prescribed radiation therapy as per standard of care
* treatment to begin within 5 weeks after surgery or biopsy
* ECOG 0, 1, or 2
* ability and willingness to provide informed consent

Exclusion Criteria:

* \< 18 years of age

Primary outcomes:
measure: Change in ferric iron levels detected by T2* MRI
timeFrame: baseline and 8 weeks
Secondary outcomes:
measure: Change in ferrous iron levels detected by T2* MRI
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Holden Comprehensive Cancer Center
state: Iowa
Study officials:
affiliation: University of Iowa
name: Bryan Allen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01488643: Observational Study on Obese Patients During General Anesthesia
Official title: Bronchospasm During General Anesthesia in Obese Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchospasm
Surgery
Obesity
Keywords: Bronchospasm
Laparoscopic Gastrectomy
Obesity
Lead sponsor: Larissa University Hospital
Sponsor class: OTHER
First posted: 2011-12-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ALL PATIENTS FROM BOTH TEAMS WILL UNDERGO TO LAPAROSCOPIC SURGERIES

Brief summary: There is increased frequency of asthma in obese patients. This study is trying to find out if there is a difference in the presence of bronchospasm during anesthesia in obese and non obese patients.

Detailed description: Obese patients come for surgery every day. In this specific population the frequency of asthma is high.

Problems from the respiratory system increase the morbidity, as they are a significant part of perioperative complications.

The frequency and the severity of bronchospasm have not been studied. Any data concerning the bronchospasm will lead to better perioperative management.

In this study the investigators study any sign of bronchospasm during surgery in obese patients.

Eligibility criteria: Inclusion Criteria:

* AGE \> 18 AND \< 78 YEARS
* BMI \< 35

Exclusion Criteria:

* MENTAL DISORDERS EMERGENCY SURGERIES

Primary outcomes:
measure: The difference in the presence of bronchospasm in obese and non obese patients
timeFrame: 90 min
Secondary outcomes:
measure: The impact of intraoperative bronchospasm on postoperative complications
timeFrame: 1 day (24 postoperative hours)
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: Larissa University Hospital
state: Thessaly
Study officials:
affiliation: UNIVERSITY HOSPITAL OF LARISSA
name: IEROPOULOS POLYCHRONIS, MD
role: PRINCIPAL_INVESTIGATOR
References: