louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03336658: Intratumoral Budding (ITB) in Preoperative Biopsies of Colon and Rectal Cancer
Official title: Assessment of Intratumoral Budding (ITB) in Preoperative Biopsies of Colon and Rectal Cancer Patients: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: CRC
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2017-11-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stages I to IV colorectal cancer

Brief summary: All the preoperative biopsies of patients suffering colorectal cancer (CRC) will be immunohistochemically stained with a pancytokeratin marker to detect Tumor buds. then, the intratumoral buds (ITB) in the densest Region of Tumor buds, namely the "hot spot" will be counted. Subsequently, the probability of N stage (lymphnodes), M stage (metastases) and disease free survival (DFS) will be calculated based on an existing logistic Regression model already developed by our previous retrospective work. Additionally, a Standardisation of ITB using a well- established Software will develop an algorithm which will help to eliminate inter- observer variability of Tumor budding Counts.


Eligibility criteria: Inclusion Criteria:

* Patients with newly diagnosed stages I and IV colorectal cancer (CRC)
* Age ≥ 18 years
* Written Informed Consent

Exclusion Criteria:

* No consent
* \< 18 years

Primary outcomes:
measure: correlation of ITB based calculated N stage with real N stage in CRC - patients
timeFrame: 24 months
Secondary outcomes:
measure: correlation of ITB based calculated DFS with real DFS in CRC - patients
timeFrame: 24 months
Other outcomes:
Locations:
city: Berne
country: Switzerland
facility: Department of visceral surgery and transplant surgery, Berne University Hospital
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Beat Schnüriger, PD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02346058: Efficacy and Safety of Esarin Gel in Chronic Venous Insufficiency and Varicose Veins
Official title: Evaluate the Efficacy and Safety of Esarin Gel in the Treatment of Chronic Venous Insufficiency or Varicose Vein Combine With Superficial Vein Thrombophlebitis in Outpatient
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Venous Insufficiency
Varicose Vein
Superficial Vein Thrombophlebitis
Lead sponsor: Ten Sun Pharma Company Limited
Sponsor class: INDUSTRY
First posted: 2015-01-26
Enrollment: 53
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation efficacy and safety of Esarin Gel in subjects with chronic venous insufficiency or varicose veins combine superficial vein thrombophlebitis.

Detailed description: Open-label,non-controlled study design with three visits (pre-treatment/baseline, treatment day 14 and day 28). Administered Esarin Gel twice daily for 28 days in subjects with chronic venous insufficiency rated between CEAP 0 and 3 or varicose veins combine superficial vein thrombophlebitis, in comparison to the pre-treatment.

Eligibility criteria: 1. Inclusion Criteria:

   * Patients of both sexes, aged above 20 years old.
   * The patient has confirmed his/her willingness to participate in the study, after being informed about all the aspects of the study that might be relevant for his/her decision to participate, and has signed and dated the informed consent form, as approved by the Institutional Review Board/ Ethics Committee (IRB/EC).
   * Presence of chronic venous insufficiency which is rated between functional classes CEAP 0 and 3.(CEAP Classes: C0:no visible or palpable signs of venous disease, C1:telangiectasies or reticular veins. C2 :apparent Varicose veins, C3 :Edema)
   * Diagnosed with superficial vein thrombophlebitis and have skin reaction by redness, swelling, fever and pain symptoms.
2. Exclusion Criteria:

   * Known allergy to the product's ingredients
   * pregnant or breastfeeding
   * patient is joining to any other clinical trail
   * Patient has not sign the informed consent form
   * Deep vein thrombosis
   * Cellulitis
   * Stasis dermatitis
   * The patient is taking non-steroids anti-inflammatory drugs( include oral ,topical creams or patch form)

Primary outcomes:
measure: Change in subject's leg swelling
timeFrame: 28 days
measure: Change in subject's leg pain
timeFrame: 28 days
Secondary outcomes:
measure: Safety Assessment through the adverse events reports
timeFrame: 28 days
measure: Improvement of patient's quality of life
timeFrame: 28 days
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: Chung C. Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03250858: Online Nutrition Advice in the UK (EatWellUK)
Official title: Randomized Control Trial to Evaluate the Effectiveness of Online Nutrition Advice in the UK (The EatWellUK Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Modification
Dietary Habits
Keywords: Personalised nutrition
Mobile web application
Lead sponsor: University of Reading
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 324
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The EatWellUK study aims to investigate the effectiveness of a mobile web application (e-Nutri), capable of delivering automated personalised nutrition advice, in increasing diet quality.

Dietary assessment is via the validated Food4Me FFQ (with an updated user interface that has been designed for better usability) and dietary feedback is derived according to adherence to an 11-item modified US Alternative Healthy Eating Index (m-AHEI).


Eligibility criteria: Inclusion Criteria:

* aged \> 18 years old

Exclusion Criteria:

* aged \< 18 years old
* not living in the UK
* pregnant/lactating
* no or limited access to internet
* following a prescribed diet for any reason
* intolerance or food allergy
* subject with diabetes, or any other metabolic disorder or illness that alters nutritional requirements

Primary outcomes:
measure: Dietary intake
timeFrame: baseline, 6 weeks, 12 weeks
Secondary outcomes:
measure: Weight
timeFrame: baseline, 6 weeks, 12 weeks
measure: Physical activity
timeFrame: baseline, 6 weeks, 12 weeks
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
state: Berkshire
Study officials:
References:
citation: Zenun Franco R, Fallaize R, Weech M, Hwang F, Lovegrove JA. Effectiveness of Web-Based Personalized Nutrition Advice for Adults Using the eNutri Web App: Evidence From the EatWellUK Randomized Controlled Trial. J Med Internet Res. 2022 Apr 25;24(4):e29088. doi: 10.2196/29088.
Clinical trial NCT01411358: Immunogenicity and Safety of AdimFlu-S 2011-2012 in Non-Elderly Adult and Elderly Subjects
Official title: Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2011-2012, in Non-Elderly Adult and Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Keywords: influenza
vaccine
immunogenicity
Lead sponsor: Adimmune Corporation
Sponsor class: INDUSTRY
First posted: 2011-08-08
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HAI) at 21 days post immunization in non-elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).


Eligibility criteria: Inclusion Criteria:

* Males or non-pregnant females and aged ≥ 18 years;
* Willing and able to adhere to visit schedules and all study requirements;
* Subjects read and signed the study-specific informed consent.

Exclusion Criteria:

* Subject or his/her family is employed by the participated hospital;
* Subjects received 2010-2011 seasonal influenza vaccine within the previous 6 months;
* History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication
* Personal or family history of Guillain-Barré Syndrome
* An acute febrile illness within 1 week prior to vaccination;
* Current upper respiratory illness, including the common cold or nasal congestion within 72 hours
* Subjects with influenza-like illness as defined by the presence of fever (temperature ≥ 38°C) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough
* Female subjects who are pregnant during the study
* Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent
* Immunodeficiency, or under immunosuppressive treatment
* Receipt of any vaccine within 1 week prior to study vaccination or expected receipt between Visit 1 (study vaccination) and Visit 2 (final collection of blood samples);
* Receipt of any blood products, including immunoglobulin in the prior 3 months;
* Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine

Primary outcomes:
measure: The primary endpoint will be the seroprotection rate which is defined as the proportion of subjects with HAI titer ≥ 40.
timeFrame: 3 weeks post vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
affiliation: National Cheng-Kung University Hospital
name: Gin-Hsiang Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06269458: The Effects of Mother-Baby Yoga and Baby Massage on Attachment and Sleep
Official title: The Effects of Mother-Baby Yoga and Baby Massage on Attachment and Sleep: A Randomized Crossover Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Newborn
Yoga
Mother-Infant Interaction
Sleep
Lead sponsor: Antalya Bilim University
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 60
Sex: ALL
Minimum age (years): 0
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Purpose: This study was conducted to examine the effects of mother-baby yoga and massage on mother-baby bonding and the baby's sleep.

Method: A randomised, crossover pilot study was conducted in the postpartum service of a hospital between January and November 2023, with 60 mothers and their babies in the postpartum period, 30 in each group. To the mothers and their babies included in the research, baby massage was applied to one group and mother-baby yoga was applied to the other. After four weeks, the groups' practices were changed. In the results of the research, characteristics related to attachment and sleep were evaluated.


Eligibility criteria: Inclusion Criteria:

* Babies in the first week of postpartum
* Healthy babies,
* Therm (37-40 W),
* The baby should be at normal birth weight (2500-4000gr),
* Mothers who know how to read and writ

Exclusion Criteria:

* Mothers with communication problems,
* Individuals whose mother or baby are monitored in intensive care after birth
* If the mother has a physical disability or any chronic disease (hypertension, diabetes mellitus, etc.),
* Psychological illness in the mother (major depression, psychosis, etc.),
* Pregnancy through assisted reproductive techniques,
* Mothers who are diagnosed with a sleep disorder and who have their babies treated for this reason.

Primary outcomes:
measure: Attachment
timeFrame: It was applied before and after the intervention (4 weeks).
measure: Weight and Sleep
timeFrame: It was applied before and after the intervention (4 weeks).
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Antalya Bilim Üniversitesi
Study officials:
References:
Clinical trial NCT02301858: Identification of Predictive and Prognostic Markers for Lung Cancer With Metastases
Official title: Identification of Predictive and Prognostic Markers for Lung Cancer With Metastases
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Cancer
Primary Tumor
Metastases
Keywords: molecular pathology
functional genomics
lung cancer
primary tumor
metastases
Lead sponsor: Sykehuset i Vestfold HF
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
First posted: 2014-11-26
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The project aims to compare the histopathological and molecular characteristics of tumour tissue from metastases with similar analyses of the primary tumour in the lung, where it is available.

The investigators will therefore perform analysis of blood samples if possible, to identify predictive markers in blood samples.

Detailed description: The investigators want to make genome analysis of tissue samples. This involves analysing the RNA, DNA methylation, for example in cancer cells. This will provide information regarding somatic changes in cancer cells, such as mutations. All of the investigators analysis will be cancer-focused, with the goal of increasing understanding of the heterogeneity.

The investigators will therefore perform analysis of blood samples if possible, to identify predictive markers in blood samples. This will then be the miRNA, RNA expression or protein expression in blood samples.

Eligibility criteria: Inclusion Criteria:

* Patients with metastasizing lung cancer where further treatment is still applicable.

Exclusion Criteria:

* Terminal patients or patients in a reduced general condition with EGOC 3-4, i.e. patients who are confined to bed more than 50% of the day, with no clinical indication to perform sampling of the tumor and metastases.
* Patients where further cancer treatment is no longer applicable.
* Patients with cognitive impairment.
* Patients with inaccessible metastases where sampling may cause distress to the patient and are at increased risk of complications.

Primary outcomes:
measure: Comparing histopathological and molecular characteristics of tumour tissue from metastases with the primary tumour in the lung
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tønsberg
country: Norway
facility: Vestfold Hospital Trust
Study officials:
References:
Clinical trial NCT03361358: Pre-Screening Study to Identify MTAP Loss in Advanced Solid Tumors or Lymphoma
Official title: Identification of MTAP Deletion in Archival Tumor Tissue: A Pre-Screening Study in Subjects With Advanced Solid Tumors or Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Solid Tumors
Lymphoma
Lead sponsor: Agios Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2017-12-04
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects appropriate for this study will be identified by the Investigators at the study sites based on their clinical judgment. This study may be conducted in subjects who are not currently eligible for an experimental therapy, recognizing that determination of the tumor's MTAP status could be useful in making future decisions about options for treatment.

Brief summary: The purpose of this study is to identify subjects with advanced solid tumors or lymphoma in which the methylthioadenosine phosphorylase (MTAP) protein has been lost.

Detailed description: Study AG270-PS-001 is a pre-screening study to identify subjects with advanced solid tumors or lymphoma in which the MTAP protein has been lost. Subjects whose tumor tissue has lost the MTAP protein may be considered for future enrollment into a Phase 1 clinical study of an experimental drug, AG-270, that is designed to inhibit the growth of tumors lacking this protein.

Identification of the loss of MTAP will rely solely on the evaluation of archival tumor tissue samples by IHC. This study is therefore non-interventional

Eligibility criteria: Inclusion Criteria:

1. Be ≥18 years of age.
2. Have a histologically confirmed diagnosis of an advanced solid tumor (other than a primary CNS malignancy) or lymphoma.
3. Have archival tumor tissue that can be provided for assessment of MTAP deletion status.
4. Have given written informed consent to participate in this study.

Exclusion Criteria:

1. Have a primary CNS malignancy (eg, GBM).
2. Have a medical or psychological condition deemed by the Investigator likely to interfere with the subject's ability to give informed consent or participate in the study.

Primary outcomes:
measure: Determination of MTAP status in tumors
timeFrame: From initiation of the Pre-Screen study until the Phase 1 study of AG-270 is activated at each study site, up to 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston, MA
state: Massachusetts
city: Nashville
country: United States
facility: Nashville, TN
state: Tennessee
city: Barcelona
country: Spain
facility: Barcelona, Spain
Study officials:
References:
Clinical trial NCT04377958: Development and Validation of a Serum Biomarker for the Diagnostic Work-up of Asthma
Official title: Development and Validation of a Serum Biomarker for the Diagnostic Work-up of Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Biomarkers
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Serum samples of asthmatic patients will be screened for serum biomarkers


Eligibility criteria: Inclusion Criteria:

* 18 - 65 years
* physician-diagnosed asthma

Exclusion Criteria:

* No clear asthma phenotype
* Presence of other pulmonary diseases (Chronic obstructive pulmonary disease, alfa-1-antitrypsine deficiency emphysema, Immunoglobulin E deficiency, allergic bronchopulmonary aspergillosis)
* \> 15 pack years
* No sputum available
* Respiratory infection
* Other inflammatory diseases (Rheumatoid Arthritis, Colitis Ulcerosa)

Primary outcomes:
measure: Serum calprotectin
timeFrame: Day 1
Secondary outcomes:
measure: Sputum calprotectin
timeFrame: Day 1
Other outcomes:
Locations:
Study officials:
affiliation: UZ Leuven
name: Lieven Dupont
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00713258: The Effect of PTH(1-84) or Alendronate on Reduction of Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) (FP-005-IM)
Official title: A 24-week, International, Multi Centre, Randomised, Double-blind, Double-dummy, Parallel Group, Phase IV Clinical Trial Investigating Changes in Back Pain in Postmenopausal Women With an Osteoporosis Related Vertebral Fracture(s) Treated With Either 100 µg PTH(1-84) Daily or 70 mg Alendronate Weekly
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Back Pain
Keywords: Postmenopausal women
Back pain
Osteoporosis related fracture
Lead sponsor: Nycomed
Sponsor class: INDUSTRY
First posted: 2008-07-11
Enrollment: 75
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this trial is to show that PTH(1-84) is superior to alendronate in reducing back pain intensity over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral fracture(s).

Secondly the objectives are to investigate any differences in patient reported outcomes between the two treatment arms over a 24-week treatment period in postmenopausal women with an osteoporosis related vertebral fracture(s).


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women with a T-score ≤ -1.5 SD and at least one osteoporosis related vertebral fracture. Chronic back pain.

Exclusion Criteria:

* Previous/current treatment and medical history.

Primary outcomes:
measure: Change in Back Pain Intensity During 24 Weeks of Treatment Using a Numerical Rating Scale.
timeFrame: Baseline and 24 weeks treatment
Secondary outcomes:
measure: Change in Physical Disability and Patient Reported Outcomes During 24 Weeks of Treatment
timeFrame: Baseline and 24 weeks treatment
Other outcomes:
Locations:
city: Roskilde
country: Denmark
facility: Nycomed
Study officials:
References:
Clinical trial NCT05407558: Does the Menstrual Phase Affect Gastric Emptying? Prospective, Observational Study
Official title: Does the Menstrual Phase Affect Gastric Emptying? Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Contents
Lead sponsor: Konya Meram State Hospital
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 24 healthy female volunteers who are of the reproductive age and have had a regular menstrual cycle for at least six

Brief summary: This prospective observational study aimed to evaluate the relationship between menstrual phase cycles and gastric emptying in female volunteers of reproductive age.

Detailed description: Volunteers included in the study will be evaluated for gastric emptying with USG in both phases of the menstrual phase. In each phase, volunteers will be evaluated for gastric emptying of both liquid food intake and a light meal. At first, 400 ml of water will be drunk after 10 hours of fasting, and gastric content will be evaluated with USG after 2 hours.

Secondly, after 10 hours of fasting, solid food intake will be evaluated. Then, after taking a light meal (toast and 200 ml tea), the volunteers will be evaluated by USG at the 6th hour.

Eligibility criteria: Inclusion Criteria:

* Female volunteers of reproductive age have had a regular menstrual cycle for at least six months

Exclusion Criteria:

* Pregnancy
* Stomach problem
* Using anticholinergics, opioids, and oral contraceptive drugs
* Hypothyroidism
* Diabetes mellitus
* Smokers

Primary outcomes:
measure: The difference in gastric volume between the two menstrual phases
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Betul Kozanhan
Study officials:
References: