louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05781737: Inflammatory Bowel Disease and Atherosclerosis Development
Official title: Inflammatory Bowel Disease and Atherosclerosis Development
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Inflammatory Bowel Diseases
Cardiovascular Diseases
Inflammation
Arterial Stiffness
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2023-03-23
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 patients with ulcerative colitis, 50 patients with Crohn disease, 50 patients without inflammatory bowel disease

Brief summary: The study will show the influence of inflammatory bowel disease on the risk of development of atherosclerosis


Eligibility criteria: Inclusion Criteria:

* Inflammatory bowel disease
* Signed informed consent

Exclusion Criteria:

* Pregnancy
* Other conditions affecting the prognosis
* Psychiatric disorders affecting the participation in the study

Primary outcomes:
measure: Intima-media thickness
timeFrame: 1 year
measure: Pulse wave velocity
timeFrame: 1 year
Secondary outcomes:
measure: All cause mortality
timeFrame: 1 year
measure: Cardiovascular mortality
timeFrame: 1 year
measure: Hospitalisation due to cardiovascular disease
timeFrame: 1 year
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: University Hospital #1
Study officials:
References:
Clinical trial NCT06031337: Salivary Expression of SOX7 in Oral Squamous Cell Carcinoma: Diagnostic Accuracy Study
Official title: Salivary Expression of SOX7 in Oral Squamous Cell Carcinoma: Diagnostic Accuracy Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Oral Cancer
Oral Squamous Cell Carcinoma
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 46
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 23 patients with oral cancer 23 healthy controls

Brief summary: The study will include patients with oral cancer and healthy controls of both sexes. Subjects having any systemic diseases or other types of cancer will be excluded. All subjects will be selected from Oral Medicine Department, Faculty of Dentistry, Al Ahram Canadian University and Fayoum University. Informed consent will be obtained from all subjects enrolled in this study after explanation of the whole procedure.


Eligibility criteria: Inclusion Criteria:

* patients with oral cancer

Exclusion Criteria:

* any systemic diseases or other types of cancer will be excluded

Primary outcomes:
measure: salivary expression of SOX7
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum University
Study officials:
References:
Clinical trial NCT05510037: Incidence and Prognostic Significance of HER-2 Status Discordance Between Primary Breast Cancer and Paired Recurrent/Metastatic Lesions
Official title: Incidence and Prognostic Significance of HER-2 Status Discordance Between Primary Breast Cancer and Paired Recurrent/Metastatic Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-08-22
Enrollment: 1299
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with available HER2 status of primary breast cancer and relapse/metastases

Brief summary: About a half of HER2-negative breast cancer show HER2-low expression that can be targeted by new antibody-drug conjugates. The main aim of this study is to describe the evolution of HER2 expression from primary BC to relapse by including HER2-low category in both primary and recurrent BC samples. Patients with matched primary and relapse BC samples were included. 1299 patients were included.


Eligibility criteria: Inclusion Criteria:

Patients with available HER2 status of primary breast cancer and relapse/metastases

Exclusion Criteria:

Patients with other malignancy

Primary outcomes:
measure: overall survival
timeFrame: up to 200 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
Study officials:
affiliation: Fudan University
name: Jian Zhang, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03906552: Effects of Acupressure and Foot Massage on Pain During Heel Lancing in Neonates
Official title: Adiyaman University
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Pain
Keywords: acupressure
massage
pain
neonate
heel lancing
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
First posted: 2019-04-08
Enrollment: 139
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: randomized controlled trial
Primary purpose: PREVENTION

Brief summary: Aim: The study was aimed to identifying the effects of foot massage and acupressure on pain during heel lancing in neonates.

Methods: A single-blinded randomized controlled trial was performed in a university hospital in Turkey between April-December 2018. Neonates were randomized into three groups as acupressure, massage and control groups. Data were obtained by using Information form, Neonatal Infant Pain Scale (NIPS), pulse oximeter device and chronometer. Acupressure was applied to the neonates in the acupressure group and massage was given to the neonates in the massage group for 2 minutes before heel lancing procedure. Pain levels of the neonates in the groups were evaluated during and 1 minute after heel lancing procedure. Furthermore, the oxygen saturation and heart rate values of the neonates in the groups were measured by pulse oximeter device before, during and after heel lancing procedure. Duration of crying and heel lancing procedure were recorded by chronometer.

Detailed description: Massage is a systematic and scientific procedure applied by using hands or special tools. As for acupressure, it is a method applied by stimulating the acupuncture points using hands and fingers by applying pressure on the meridians in body.Both methods are reliable, economic and easy to learn and apply. Review of the related literature indicates studies on the effectiveness of acupressure and foot massage on reducing pain in neonates.

Eligibility criteria: Inclusion Criteria:

* having 2500-4000 gr body weight and being term neonates,
* having APGAR score of over 7 five minutes after birth,
* having no health problems detected in the newborn examination after birth,
* having received no painful interventions apart from Hepatitis B and Kvit after birth,
* being with the mother and being fed orally,
* having had breast milk within 30 minutes before heel lancing
* having a clean diaper.

Primary outcomes:
measure: Pain Scale
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
measure: Pulse Oximeter Device
timeFrame: 1 minute
measure: Chronometer
timeFrame: 2 minutes
Locations:
city: Adiyaman
country: Turkey
facility: Adiyaman University
Study officials:
References:
Clinical trial NCT04084652: Mycoprotein and Muscle Protein Synthetic Response
Official title: Comparing the Muscle Protein Synthetic Response to Ingestion of Mycoprotein vs Protein Isolated From Mycoprotein
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anabolic Response to Mycoprotein and Micronutrient Ingeston
Lead sponsor: University of Exeter
Sponsor class: OTHER
Collaborators: name: Quorn
First posted: 2019-09-10
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Dietary protein is vital for the preservation of health and optimal adaptation to training. However, traditional animal proteins come with a number of economic, environmental, and ethical issues. Accordingly, there is a need to develop an understanding of the utility of more sustainable non-animal derived dietary proteins to support our nutrition. Mycoprotein, produced by Quorn Foods™, has recently been shown to stimulate a greater anabolic response within skeletal muscle compared with milk protein, suggesting its utility within sports nutrition. However, it is unclear what accounted for the greater anabolic response of mycoprotein. One explanation could be the non-protein nutrients contained within mycoprotein (e.g. fibre, carbohydrate, fat or micronutrients).

Therefore, the present study will compare the muscle anabolic response between mycoprotein (MYC) as a whole food and the protein isolated from mycoprotein (PIM).


Eligibility criteria: Inclusion Criteria:

* BMI between 18 and 30.
* Resistance trained

Exclusion Criteria:

* Any metabolic impairments.
* Cardio/pulmonary diseases.
* Chronic use of over the counter pharmaceuticals
* A personal or family history of epilepsy, seizures or schizophrenia.
* Allergic to mycoprotein/Quorn/edible fungi/environmental mould products.

Primary outcomes:
measure: Muscle protein synthesis
timeFrame: 7.5 hours
Secondary outcomes:
measure: Plasma Amino Acid Kinetics
timeFrame: 7.5 hours
measure: Blood Glucose
timeFrame: 7.5 hours
measure: Serum Insulin
timeFrame: 7.5 hours
Other outcomes:
Locations:
city: Exeter
country: United Kingdom
facility: University of Exeter
Study officials:
References:
Clinical trial NCT05111652: Electromyographic Assessment of the Shoulder Stabilizing Musculature in CrossFit® Athletes
Official title: Electromyographic Assessment of the Shoulder Stabilizing Musculature in CrossFit® Athletes. An Observational Analytical Study of Case-controls Prevalence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Muscle Strain
Electromyography
Trapezius Muscle Strain
Keywords: Serratus muscle strain
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Athletes and amateurs who practice CrossFit® discipline, who have mastered the basic exercises of Pull-up and Push-Press.

Brief summary: This is an observational analytical study of prevalent cases and controls.

Detailed description: Approximately 39 subjects who practice CrossFit at least 6 hours a week are invitated to participate in this observational study. It will measure the activation of trapezius and Serratus muscles by Electromyography experiencing a feeling of fatigue 7-8 in PushPress and PullUps.

Eligibility criteria: Inclusion Criteria:

* Practicing CrossFit® for at least 1 year
* A minimum of 6 hours per week CrossFit® training
* No shoulder pain at the time of measurement

Exclusion Criteria:

* Tendinitis
* Bursitis
* Sistematic disease
* Nurological disease
* Central or periferic disease

Primary outcomes:
measure: Observation of Basal Activation in Trapezius and Serratus muscles and after Push-Press and Pull-Up exercises assessed by Electromyographic mDurance®
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06765252: Effect of Genetic Polymorphism on Capecitabine-Induced Toxicity in Egyptian Cancer Patients
Official title: Effect of Genetic Polymorphism on Capecitabine-Induced Toxicity in Egyptian Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Breast Cancer
Keywords: Polymorphism
CES1
Capecitabine
Toxicity
Cancer
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Menoufia University
First posted: 2025-01-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Egyptian cancer patients presenting to the department of Clinical Oncology, Faculty of Medicine, Menoufia University.

Brief summary: The goal of this observational study is to study the effect of a single nucleotide polymorphism in the CES1 gene (rs2244613) on capecitabine-induced toxicity in Egyptian cancer patients. This study will help in understanding the interindividual variability in the CES1 gene and the effect of a single nucleotide polymorphism in this gene (rs2244613) on capecitabine-induced toxicity in participants already taking capecitabine-based chemotherapy as part of their regular medical care.


Eligibility criteria: Inclusion Criteria:

* Patients with breast or colorectal cancer receiving capecitabine-based chemotherapy
* Age \> 18 years
* ECOG PS 0-2.

Exclusion Criteria:

* Patients treated with irinotecan
* Lack of physical integrity of the upper gastrointestinal tract
* Patients with malabsorption syndrome
* Patients having inability to take oral medication
* Patients with poor performance status
* Patients with chronic diarrhea as ulcerative colitis or Crohn's disease

Primary outcomes:
measure: Occurrence of gastrointestinal toxicity
timeFrame: Six months
measure: Occurrence of hand-foot syndrome
timeFrame: Six months
Secondary outcomes:
measure: Occurrence of hematological toxicity
timeFrame: Six months
measure: Occurrence of hepatic toxicity
timeFrame: Six months
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Department of Clinical Oncology, Faculty of Medicine, Menoufia University
state: Menoufia
Study officials:
References:
Clinical trial NCT00326352: Comparison of Sedation/Analgesia: Midazolam/Morphine Vs Propofol/Remifentanil
Official title: Comparison of Sedation/Analgesia: Midazolam/Morphine Vs Propofol/Remifentanil
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Shoulder Dislocation
Keywords: Sedation
Propofol
Remifentanil
recovery
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: NHS Lothian
First posted: 2006-05-16
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: For reduction of dislocated shoulder, sedation with propofol and remifentanil should give satisfactory operating conditions and pain relief, and significantly reduce the time to full recovery, compared with morphine and midazolam

Detailed description: Propofol is a recognised agent for sedation and remifentanil is a short acting opioid analgesic. We intend to provide sedation with propofol, 0.5 mg/Kg, and analgesia with remifentanil 0.5 microgram/Kg for reduction of dislocated shoulders. This will be a randomised sex-stratified comparison with current therapy which is midazolam incrementally up to a maximum of 0.15 mg/Kg, and morphine incrementally up to 0.15 mg/Kg. The primary outcome measure is time to full recovery. Secondary aspects are pain or discomfort during the procedure and operating conditions.

Eligibility criteria: Inclusion Criteria:

- Anterior dislocation of the shoulder suitable for manual reduction

Exclusion Criteria:

* significant other illness
* body weight 25% greater than expected
* fear of oxygen masks
* alcohol intoxication

Primary outcomes:
measure: Time to full recovery
Secondary outcomes:
measure: Operating conditions
measure: Pain or discomfort
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary
state: Midlothian
Study officials:
affiliation: University of Edinburgh
name: Gordon B Drummond, FRCA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dunn MJ, Mitchell R, Souza CD, Drummond G. Evaluation of propofol and remifentanil for intravenous sedation for reducing shoulder dislocations in the emergency department. Emerg Med J. 2006 Jan;23(1):57-8. doi: 10.1136/emj.2004.021410.
Clinical trial NCT02115152: Neoadjuvant Trial of Capecitabine for Axillary Lymph Node Positive Operable Breast Cancer
Official title: Phase II Neoadjuvant Trial of Capecitabine, Cyclophosphamide and Epirubicin for Patients With Axillary Lymph Node Positive Stage II-III Operable Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Stage II Breast Cancer
Stage III Breast Cancer
Keywords: Capecitabine
Neoadjuvant therapy
Early Breast Cancer
Lead sponsor: Guangxi Medical University
Sponsor class: OTHER
First posted: 2014-04-15
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This randomized phase II trial compared pathologic response rates (pCR) of early breast cancer following neoadjuvant fluorouracil-epirubicin-cyclophosphamide(FEC) and capecitabine-epirubicin-cyclophosphamide (XEC).


Eligibility criteria: Inclusion Criteria:

* Females aged 18-70 with histologically proven, core-biopsied, Stage II-III invasive breast cancer
* No distant disease

Exclusion Criteria:

- Inadequate heart or liver or kidney function

Primary outcomes:
measure: pathologic response rates (pCR)
timeFrame: The breast sample will be evaluaed on the day of surgery during the cycle 4, an expected average of 12 weeks.
Secondary outcomes:
measure: DFS(Disease free survial)
timeFrame: Participants will be evaluated on Day 1 of each cycle during chemotherapy, and Day 1 every 3 months after completion of chemotherapy. The expected average of 5 years.
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Hematologic, renal, and hepatic funcion will be assessed after each cycle and at the end of therapy, an expected average of 3 weeks.
Other outcomes:
Locations:
city: Nanning
country: China
facility: Breast Cancer Surgery Department of Guangxi Medical University Cancer Center
state: Guangxi
Study officials:
affiliation: Guangxi Medical University Cancer Center
name: Jianlun Liu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05805852: Challenges in Management of Abdominal Trauma in Sohag University Hospital A Prospective Study
Official title: Challenges in Management of Abdominal Trauma in Sohag University Hospital A Prospective Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Abdominal Trauma
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-04-10
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: any patient presented with abdominal trauma

Brief summary: The present study will be conducted to evaluate the different patterns of abdominal trauma patients and their management in the Emergency Department of Sohag University Hospital

Detailed description: The present study will be conducted to evaluate the different patterns of abdominal trauma patients and their management in the Emergency Department of Sohag University Hospital This study will be a prospective study which will be conducted at the Emergency Department of Sohag University Hospital the study population include all patients with abdominal trauma

Eligibility criteria: Inclusion Criteria:

* any patient presented with abdominal trauma

Exclusion Criteria:

* Patients with extra abdominal injuries

Primary outcomes:
measure: mortality at final follow up
timeFrame: one month
Secondary outcomes:
measure: morbidity
timeFrame: one month
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
References:
Clinical trial NCT05643352: Barbed Reposition Pharyngoplasty in Patients Complaining of Unilevel Palatal Snoring
Official title: Patient-reported Outcomes of Barbed Reposition Pharyngoplasty in Unilevel Palatal Snoring: a Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Snoring
Sleep-Disordered Breathing
Keywords: Pharyngoplasty
Barbed reposition pharyngoplasty
Snoring
Surgery
Lead sponsor: AZ Delta
Sponsor class: OTHER
First posted: 2022-12-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to determine whether there is a statistically significant difference in snoring intensity before and after performing a Barbed Reposition Pharyngoplasty as a single-level snoring procedure. The investigators aim to determine whether this is a valid alternative to the more classical techniques of pharyngoplasty. Furthermore, the investigators also wish to map the various postoperative complications and compare them with those of the more conventional techniques. The investigators compare the snoring intensity before surgery with the snoring intensity at 2 weeks (first postoperative control), at 6 weeks (second postoperative control) and at 6 months (Third postoperative control).

For the evaluation of snoring, the investigators use 4 scales/questionnaires. These questionnaires are currently also used as standard at the outpatient clinic for snoring problems. These 4 scales/questionnaires are completed at every check-up.

During the first postoperative check-up, the postoperative side effects are checked (bleeding, infection, readmission, needed consultation with another doctor, date of resumption of work). The investigators also map the pain with a visual analog scale and measure this the day after the operation and let the patient fill it in 3 days, 1 week and 2 weeks after the operation.


Eligibility criteria: Inclusion Criteria:

* single-level retro-palatal collapse observed during drug-induced sleep endoscopy (DISE)

Exclusion Criteria:

* OSAS defined as having an obstructive AHI (OAHI) ≥ 30
* Obese patients with a body mass index (BMI) ≥ 30 kg/m².
* Patients with multilevel airway collapse observed during DISE
* Patients younger than 18 years old.

Primary outcomes:
measure: Change in Snoring intensity
timeFrame: At 2 weeks, at 6 weeks and at 6 months
measure: Change in Snoring severity
timeFrame: At 2 weeks, at 6 weeks and at 6 months
measure: Change in Snoring score
timeFrame: At 2 weeks, at 6 weeks and at 6 months
Secondary outcomes:
measure: Change in Epworth Sleepiness Scale
timeFrame: At 2 weeks, at 6 weeks and at 6 months
Other outcomes:
Locations:
city: Roeselare
country: Belgium
facility: Neus-, keel- en oorziekten, gelaats- en halschirurgie AZ Delta
Study officials:
References: