louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02695849: A Study of Prevalence of EGFR Mutations in Participants With NSCLC
Official title: An Epidemiology Study of the Prevalence of Epidermal Growth Factor Receptor (EGFR) Mutations in Patients Diagnosed With Non-squamous Non-small Cell Lung Cancer (NSCLC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-small cell lung cancer (NSCLC)
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-03-01
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with non-squamous non-small cell lung cancer (NSCLC)

Brief summary: This is a non-interventional, local, multicenter, cross-sectional study to determine the prevalence of epidermal growth factor receptor (EGFR) mutations in participants diagnosed with non-squamous non-small cell lung cancer (NSCLC).


Eligibility criteria: Inclusion Criteria:

* Informed consent form signature
* Jordanian male and female participants greater than or equal to (\>=) 18 years of age
* Histologically confirmed NSCLC
* Not participating in a study that involves an investigational agent within 30 days prior to enrollment

Exclusion Criteria:

* Other primary malignancy
* Fine needle aspiration samples

Primary outcomes:
measure: Percentage of Participants with EGFR mutations
timeFrame: Day 1
Secondary outcomes:
measure: Percentage of Participants with types of EGFR mutations
timeFrame: Day 1
Other outcomes:
Locations:
city: Amman
country: Jordan
city: Amman
country: Jordan
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02392949: Does Passive Spinal Mobilization Improve Shoulders Strength in Healthy Adults?
Official title: Does Passive Spinal Mobilization Improve Shoulders Strength in Healthy Adults?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Spine
mobilization
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2015-03-19
Enrollment: 22
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: Previous studies have shown that peripheral muscles weakness or inhibition is related to spinal disorders. Passive mobilization and manipulation are likely to reverse such muscle weakness for patients with spinal pain. The purpose of the study was to assess the effect of spinal mobilization on the maximal muscle strength of the shoulders.

Detailed description: Participants without existing neck pain or shoulder problem will be recruited. Subjects will be screened by 2 investigators independently for shoulder muscle weakness. Weakness is determined by the strength of the other side when one side is remarkably weaker or by comparing with the general strength of the deltoid muscle if both sides are suspected involved.

Suitable participants will undergo shoulder strength testing with a handheld dynamometer. Participants will be divided into the intervention group and the control group randomly. The shoulder strength will be tested by the second, individual blinded assessor.

Subjects in the intervention group will receive passive spinal mobilization at cervical 4-5 segment on the involved side(s); the control group will receive placebo intervention.

Each participant will be tested for 2 times, before and immediately after a C4-5 joint mobilization on the involved side (s).

Eligibility criteria: Inclusion Criteria:

* Healthy adults

Exclusion Criteria:

* People with active neck or should pain

Primary outcomes:
measure: Deltoid muscle strength (dynamometer)
timeFrame: 10 minutes after the intervention
measure: Electromyography (EMG) (signal from deltoid muscle)
timeFrame: 10 minutes after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Chi Ngai Lo, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04800549: Effect of Black Mulberry Lollipop on Prevention of Oral Mucositis in Children
Official title: The Effect of Black Mulberry Lollipop and Sodium Bicarbonate Used in Oral Care on Prevention of Oral Mucositis Among Children Receiving Chemotherapy Due to Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Mucositis
Keywords: Keywords: chemotherapy, oral mucositis, black mulberry, bicarbonate, paediatric oncology
Lead sponsor: Sapanca Ilce Devlet Hastanesi
Sponsor class: OTHER_GOV
Collaborators: name: Okan University
First posted: 2021-03-16
Enrollment: 69
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The power of the test in the study was calculated by using G\*Power 3.1 program. While Type I error is 0.05 and the power of the test is 0.80 (α= 0.05, 1-β= 0.80), minimal sample size was calculated as 62 children (31 children in each group). By considering the losses that may occur from the sample during the study due to any reason, it was planned to include 40 children in both experimental and control groups. Follow-up lost occurred in 5 patients from experimental group and 6 patients in the control group during the study. The study was completed with 69 paediatric patients including 34 in the experimental group and 35 in the control group.
Primary purpose: PREVENTION

Brief summary: THE EFFECT OF BLACK MULBERRY LOLLIPOP AND SODIUM BICARBONATE USED IN ORAL CARE ON PREVENTION OF ORAL MUCOSITIS AMONG CHILDREN RECEIVING CHEMOTHERAPY DUE TO CANCER

Detailed description: The study was conducted experimentally to determine the effect of black mulberry lollipop and sodium bicarbonate used in oral care on prevention of oral mucositis in children followed up due to the diagnosis of cancer. Sodium bicarbonate and black mulberry treatment were compared to prevent oral mucositis in 69 children receiving chemotherapy due to cancer. While 35 children were assigned to the experimental group (sodium bicarbonate + black mulberry lollipop application), 34 were assigned to the control group (sodium bicarbonate application).

Eligibility criteria: Inclusion Criteria:

* Being in the age group of 3-18 years
* Being hospitalised for chemotherapy treatment
* Not having oral mucositis
* No using another method to protect oral mucosa during the study period
* Not having the history of black mulberry (similar fruit berries, blackberries, etc.) allergy
* Not having intolerance to cold

Exclusion Criteria:

-Not having food in mouth

Primary outcomes:
measure: Patient Follow-up Form
timeFrame: 3 minute
measure: Children's International Mucositis Evaluation Scale
timeFrame: 2 minute
measure: Nurse Observation Chart of Child Mucositis Evaluation
timeFrame: 10 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Sağlık Bakanlığı Sapanca Ilçe Hastanesi
state: Türkiye
Study officials:
References:
Clinical trial NCT04175249: Pizza Meal Challenge and Immunometabolism (PIMETA)
Official title: Effects of a Pizza Meal Challenge on the Immunometabolism of Monocytes and T Cells
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Salt challenge
Immune cell metabolism
Oxygen consumption rate
Extracellular acidification rate
Cytokine production
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: High salt intake is a major risk factor for cardiovascular events, including stroke, heart disease and kidney failure. Pizza is a popular salty food. In this exploratory pilot study, the effects of a pizza meal challenge on immunometabolism in healthy subjects will be tested.


Eligibility criteria: Inclusion Criteria:

- Healthy men and women

Exclusion Criteria:

* Severe, manifest illnesses in need of treatment
* Pathological lab results
* Inability to understand significance and scope of the study

Primary outcomes:
measure: Oxygen consumption rate of immune cells
timeFrame: 3 hours after the pizza compared to baseline
Secondary outcomes:
measure: Oxygen consumption rate of immune cells
timeFrame: 3 and 8 hours after the pizza adjusted for plasma sodium concentration compared to baseline
measure: Plasma sodium
timeFrame: 3 and 8 hours after the pizza compared to baseline
measure: Mitochondrial membrane potential of immune cells
timeFrame: 3 and 8 hours after the pizza compared to baseline
measure: Extracellular acidification rate of immune cells
timeFrame: 3 and 8 hours after the pizza compared to baseline
measure: Interleukin 17 release after monocyte and T cell co-culture
timeFrame: Cell isolation at baseline and 3 hours after the pizza followed by 72 hours of co-culture
measure: Interferon-gamma release after monocyte and T cell co-culture
timeFrame: Cell isolation at baseline and 3 hours after the pizza followed by 72 hours of co-culture
measure: Adenosine triphophate production of immune cells
timeFrame: 3 and 8 hours after the pizza compared to baseline
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Experimental & Clinical Research Center
Study officials:
affiliation: Charite University, Berlin, Germany
name: Dominik N. Müller, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University, Berlin, Germany
name: Anja Mähler, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Geisberger S, Bartolomaeus H, Neubert P, Willebrand R, Zasada C, Bartolomaeus T, McParland V, Swinnen D, Geuzens A, Maifeld A, Krampert L, Vogl M, Mahler A, Wilck N, Marko L, Tilic E, Forslund SK, Binger KJ, Stegbauer J, Dechend R, Kleinewietfeld M, Jantsch J, Kempa S, Muller DN. Salt Transiently Inhibits Mitochondrial Energetics in Mononuclear Phagocytes. Circulation. 2021 Jul 13;144(2):144-158. doi: 10.1161/CIRCULATIONAHA.120.052788. Epub 2021 Apr 28.
Clinical trial NCT03998449: Immunogenicity of Cholera Vaccine in Children With IBD
Official title: Evaluation of Immunogenicity of Cholera Vaccine in Children With Inflammatory Bowel Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholera
Inflammatory Bowel Diseases
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Medical University of Gdansk
First posted: 2019-06-26
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Assessment of the immunogenicity and safety of immunization against cholera in children with inflammatory bowel disease.


Eligibility criteria: Inclusion Criteria:

* diagnosis of Crohn's disease or ulcerative colitis based on standard clinical, endoscopic, histologic and radiographic criteria (Porto criteria),
* no vaccination against cholera in the past,
* written consent of the patient's legal guardians and the patient himself if he/she turns 16 years of age.

Exclusion Criteria:

* serious exacerbation of inflammatory bowel disease defined as Paediatric Ulcerative Colitis Activity Index (PUCAI) \> 65 points for patients with ulcerative colitis or Pediatric Crohn's Disease Activity Index (PCDAI) \> 40 points for patients with Crohn's disease.

Primary outcomes:
measure: Achieving seroprotective antibody concentration
timeFrame: 4-6 weeks after the second dose
Secondary outcomes:
measure: Adverse effects
timeFrame: 3 days after each dose
measure: Inflammatory bowel disease exacerbation occurrence.
timeFrame: 4-6 weeks after the second dose
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw
Study officials:
affiliation: Medical University of Warsaw
name: Aleksandra Banaszkiewicz, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04678349: The Role of Partial Hydrolyzed Guar Gum in High Stoma Output Management Among Cancer Patients With Ileostomy
Official title: The Role of Partial Hydrolyzed Guar Gum in High Stoma Output Management Among Cancer Patients With Ileostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, Malaysia
First posted: 2020-12-21
Enrollment: 29
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: this is a cross sectional intervention study to investigate the role of partial hydrolyzed guar gum in high stoma output management among cancer patients with ileostomy. This study hypotheses there is improvement in stoma output in PHGG if compare with control. There are two groups of subjects in this study. Conventional group (CG) will include retrospective historical data (those subjects with post-operative ileostomy) from Jan 2016 to June 2019. Intervention group (PHGG) will be subjects with ileostomy which involves prospective intervention by giving partial hydrolyzed guar gum upon start orally. Data on stoma output (volume \& consistency), length of hospital stay, readmission within 30-days discharged and dietary intake will be recorded in data collection form.


Eligibility criteria: Inclusion Criteria:

* Cancer patients with ileostomy
* At least 18 years of age
* Malaysian

Exclusion Criteria:

* Not cancer patients with ileostomy
* Patients who participate in other study at the same time
* Vulnerable subjects
* Palliative patients
* Patient has fistula

Primary outcomes:
measure: ileostomy stoma output
timeFrame: up to 1 month
measure: ileostomy stoma output
timeFrame: up to 1 month
Secondary outcomes:
measure: Length of hospital stay
timeFrame: up to 1 month
measure: Readmission within 30-days discharged
timeFrame: up to 1 month
measure: Dietary intake
timeFrame: up to 1 month
measure: dietary intake
timeFrame: up to 1 month
Other outcomes:
Locations:
city: Putrajaya
country: Malaysia
facility: National Cancer Institute
Study officials:
affiliation: Department of Dietetics and Food Service, Institut Kanser Negara
name: ChiouYi Ho
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01950949: The Correlational Study of PPV in Various VT in Mechanically Ventilated Patients
Official title: The Correlational Study of Pulse Pressure Variation in Various Tidal Volume in Mechanically Ventilated Patients Under General Anaesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiration, Artificial
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2013-09-26
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Mesquida, J et al showed there was a significant linear correlation between pulse pressure variations under tidal volume 6 ml/kg and 8 ml/kg in patients after the resuscitation phase of severe sepsis and septic shock. No study revealed the actual relationship between various PPV under different VT. So we hypothesized that there were relationship between various PPV in different tidal volume settings. The objective of this study was to examine the relationship between various PPV.


Eligibility criteria: Inclusion Criteria:

scheduled for elective abdominal surgeries ASA (American Society of Anesthesiologists) I or II BMI 18-25 preoperative examination is normal

Exclusion Criteria:

acute lung injure acute respiratory distress syndrome cardiovascular diseases neurological disease renal or hepatic disease diabetes mellitus BMI less than 18 kg/m2 or greater than 25 kg/m2

Primary outcomes:
measure: invasive arterial blood pressure as a Measure of Safety
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Liu Y, Lou JS, Mi WD, Yuan WX, Fu Q, Wang M, Qu J. Pulse pressure variation shows a direct linear correlation with tidal volume in anesthetized healthy patients. BMC Anesthesiol. 2016 Sep 8;16:75. doi: 10.1186/s12871-016-0233-y.
Clinical trial NCT01508949: Effect of Liraglutide on Weight and Appetite in Obese Subjects With Type 2 Diabetes
Official title: NNC 90-1170 Mechanism of Action: A Single-centre, Randomised, Double-blind, Parallel-group, Placebo-controlled Trial Evaluating the Effect of NNC 90-1170 on Weight and Appetite in Obese Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-01-12
Enrollment: 35
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 trial is conducted in Europe. The aim of the trial is to investigate the effect of NNC 90-1170 (liraglutide) on weight and appetite in obese subjects with type 2 diabetes treated with diet and/or sulphonylurea or repaglinide.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* Diet treated and/or subjects in monotherapy with sulphonylurea or repaglinide
* HbA1c for diet treated subjects 6.5-12%, both inclusive
* HbA1c for sulphonylurea or repaglinide treated subjects maximum 10%
* Body mass index (BMI) at least 27 kg/m\^2
* Euthyroid subjects
* Fasting blood glucose 7-14 mmol/l

Exclusion Criteria:

* Impaired liver function
* Impaired renal function
* Cardiac problems
* Uncontrolled treated/untreated hypertension
* Recurrent severe hypoglycaemia as judged by the Investigator
* Known or suspected allergy to trial product or related products
* Use of any drug (except for OHAs (oral hypoglycaemic agents), which in the Investigator's opinion could interfere with the glucose level or body weight. Stable doses, for 3 months or greater, of thyroid hormone replacement are allowed

Primary outcomes:
measure: Change in weight
Secondary outcomes:
measure: Total fat mass (assessed by use of DEXA (dual energy X-ray absorptiometry) scan)
measure: Waist circumference
measure: Spontaneous energy intake assessed in connection to the ad libitum lunch meal
measure: Appetite assessed in connection with the fixed breakfast meal (assessed by the use of VAS (visual analogue scale))
measure: Gastric emptying rate
measure: Energy expenditure
measure: HbA1c (Glycosylated Haemoglobin)
measure: Adverse events
Other outcomes:
Locations:
city: Frederiksberg C
country: Denmark
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Harder H, Nielsen L, Tu DT, Astrup A. The effect of liraglutide, a long-acting glucagon-like peptide 1 derivative, on glycemic control, body composition, and 24-h energy expenditure in patients with type 2 diabetes. Diabetes Care. 2004 Aug;27(8):1915-21. doi: 10.2337/diacare.27.8.1915.
Clinical trial NCT01846949: Surveillance Study for HCC by Combining Biomarkers With Imaging (ALDUS)
Official title: Study for Clinical Significance of Use of Alphafetoprotein (AFP), AFP-L3 and Des-gamma-carboxy Prothrombin (DCP) Versus US Alone in Surveillance for HCC
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis
Lead sponsor: ALDUS Study Group
Sponsor class: OTHER
First posted: 2013-05-06
Enrollment: 1000
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 compensated cirrhosis.

Brief summary: This study is intended to be a prospective observational study at multiple sites, not a randomized controlled trial (RCT). The uses of the biomarkers has been approved by government regulations and adopted for surveillance programs in some countries, thus an RCT which compares patients followed by US alone with patients followed by both US and the biomarkers would raise an ethical conflict, especially in countries where the biomarkers have been routinely used.

For this study, enrolled patients will be followed by US and the biomarkers at regular intervals and classified after completing the study to evaluate the clinical effectiveness of the biomarkers. The comparisons of sensitivity, specificity, and other parameters with respect to tumor characteristics will be made among US alone, the biomarkers, and combined use of US and the biomarkers. Also economical effectiveness of using the biomarkers will be investigated in this study.

Requirement status is monitored every month.

Detailed description: Data are being stored in the electric data capture (EDC) server.

Eligibility criteria: Inclusion Criteria:

* Patients with compensated cirrhosis. No discrimination by underlying causes will done.
* Patients aged 18 years and older
* Patients agree to the informed consent

Exclusion Criteria:

* Patients with liver cancer at the time of enrollment
* Patients who have experienced HCC or other malignant tumor with in five (5) years
* Women with pregnancies
* Patients who are likely to be transplanted within one (1) year
* Patients with ≥ 3 mg/dL of total bilirubin
* Patients with uncontrollable ascites
* Patients with ≥ Grade II of hepatic encephalopathy

Primary outcomes:
measure: Hepatocellular carcinoma
timeFrame: Expected time frame; 2.5 years
Secondary outcomes:
measure: Survival
timeFrame: 2 and 5 year after patient enrollment
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Study officials:
References:
Clinical trial NCT06092749: Chronic Unilateral Lumbar Radicular Pain
Official title: Effectiveness of Transgrade vs Interlaminar Epidural Steroid Injection for Chronic Unilateral Lumbar Radicular Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuropathic Pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic neuropathic lumbar pain is among one of the most widespread complaints of patients.Many approaches have been attempted to target chronic pain, with varying efficacy and risks. Transgrade (TG) epidural injection is a new technique using a Racz- Coudé needle for epidural access at a "transgrade" angle without requiring any specialized hardware or accessories. Interlaminar (IL) epidural steroid injection (ESI) is one of the procedures that involves the delivery of injectate to the epidural space through directing a needle between the laminae of two adjacent vertebrae.


Eligibility criteria: Inclusion Criteria:

* \> 6-month history of persistent pain in one leg with back pain.
* Capable of giving informed consent.
* Unsatisfactory response to conventional treatments including physical therapy or medications with a numeric rating scale (NRS) ≥ 5.

Exclusion Criteria:

* Previous lumbar spinal surgery.
* Myelopathy.
* Rheumatoid disorders.
* Psychiatric disorders
* Bleeding or coagulation disorders

Primary outcomes:
measure: The average numeric rating scale (NRS) pain scores
timeFrame: at 12 weeks after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain-Shams University Hospitals
Study officials:
References: