louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03908892: Effect of Zanthoxylum Nitidum Tincture for Paronychia Caused by Afatinib
Official title: A Clinical Study on the Treatment of Paronychia Caused by Afatinib With Zanthoxylum Nitidum Tincture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Paronychia
Keywords: Paronychia
Zanthoxylum nitidum tincture
Afatinib
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized control trial evaluating the efficacy of zanthoxylum nitidum tincture on preventing progression of paronychia caused by afatinib from grade 1 to grade 2/3. Enrolled participates will randomly receive original treatment or original treatment plus zanthoxylum nitidum tincture immersion of the sick nail(s).


Eligibility criteria: Inclusion Criteria:

1. Pathologically or cytologically confirmed non-small cell lung cancer；
2. Undergoing treatment with afatinib；
3. With grade 1 paronychia；
4. Age between 18 to 80 years old；
5. Estimated life expectancy of more than months；
6. With the written informed consent.

Exclusion Criteria:

1. Paronychia before afatinib treatment;
2. Grade 2 or severer paronychia;
3. Stop using afatinib or with reduced dose of afatinib;
4. Currently diagnosed with severe encephalopathy or psychiatric disorders affecting patients ability of self expression.
5. Has other legal, medical or ethical reasons that patients are not appropriate for clinical study.

Primary outcomes:
measure: Paronychia progress rate
timeFrame: Through study completion, an average of 10 days.
Secondary outcomes:
measure: Time to paronychia progress
timeFrame: Through study completion, an average of 10 days.
measure: Time to paronychia relief
timeFrame: Through study completion, an average of 10 days.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Hospital of Chinese Medicine
state: Guangdong
Study officials:
References:
Clinical trial NCT06657092: Ultrasound Guided Erector Spinae Plane Block
Official title: Ultrasound Guided Erector Spinae Plane Efficacy of Erector Spinae Plane Block for Analgesia in Breast Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Diseases
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2024-10-24
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were randomized into two groups, ESPB and control.
Primary purpose: PREVENTION

Brief summary: Patients were randomized into two groups, ESP and control. Single-shot ultrasound (US)-guided ESP block with 20 ml 0.25% bupivacaine at the T4 vertebral level was performed preoperatively to all patients in the ESP group. The control group received no intervention. Patients in both groups were provided with intravenous patient-controlled analgesia device containing morphine for postoperative analgesia.


Eligibility criteria: Inclusion Criteria:

1. 18-65 age
2. Patients who scheduled for bilateral reduction mammoplasty
3. ASA Class I-II

Exclusion Criteria:

1. Coagulopaty

Primary outcomes:
measure: Total opioid consumption
timeFrame: Postoperative total opioid consumption in miligrams will be recorded at hour 24
Secondary outcomes:
measure: Intraoperative opioid consumption
timeFrame: At the end of the operation
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli Unıversity
state: Izmit
Study officials:
References:
Clinical trial NCT03449992: The Effects of Nitrate Supplementation on Elite Runners
Official title: The Effects of Beet-root Juice Supplementation on Exercise Economy, Rating of Perceived Exertion and Running Mechanics in Elite Distance Runners
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutrition
Physical Performance
Sport Physiology
Nitrates
Elite Athletes
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
Collaborators: name: Camilo Jose Cela University
name: Universidad Politecnica de Madrid
First posted: 2018-03-01
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Twelve elite distance runners were randomly assigned to either an intervention group or a placebo group. Participants in each group consumed beetroot juice or a placebo drink for 15 consecutive days.
Primary purpose: OTHER

Brief summary: This study analyzed the effects of 15 days of beetroot juice supplementation on different performance measures in elite Spanish distance runners

Detailed description: This study analyzed the effects of 15 days beetroot juice supplementation on the VO2max, running economy, exercise perceived exertion, muscle power and locomotion mechanics in a group of 12 elite Spanish middle and long distance runners

Eligibility criteria: Inclusion Criteria:

* Competing in national and international events
* Personal best in urban 10k: 33 minutes 0 seconds

Exclusion Criteria:

* Injury

Primary outcomes:
measure: Running economy
timeFrame: Changes from baseline at 15 days
Secondary outcomes:
measure: Time to exhaustion
timeFrame: Changes from baseline at 15 days
measure: Muscle power
timeFrame: Changes from baseline at 15 days
measure: Muscle oxygenation
timeFrame: Changes from baseline at 15 days
measure: RPE
timeFrame: Changes from baseline at 15 days
measure: Running mechanics
timeFrame: Changes from baseline at 15 days
Other outcomes:
Locations:
Study officials:
affiliation: Universidad Autonoma de Madrid
name: Carlos Balsalobre-Fernández, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05643092: Biomarker and Imaging Package Study in Immune Effector Cell-Associated Neurotoxicity Syndrome
Official title: Biomarker and Imaging Package Study in Immune Effector Cell-Associated Neurotoxicity Syndrome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Immune Effector Cell Associated Neurotoxicity Syndrome
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
Collaborators: name: Jinan Military General Hospital
name: Changhai Hospital
First posted: 2022-12-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a prospective observational study using a consecutive patient sample.

Brief summary: CAR T-cell therapy is a promising innovative therapy for hematological malignancies. Immune effectors cells-associated neurotoxicity syndrome (ICANS) is a significant complication of CAR therapy. The goal of this study is to understand what brain mechanisms become disrupted when patients experience ICANS. The study will test the hypothesis that cerebrospinal fluid catecholamines and multimodal magnetic resonance imaging are affected in this disorder.

To test this hypothesis, the study will measure cerebrospinal fluid catecholamines in ICANS patients and evaluate brain magnetic resonance imaging for these participants. This study may contribute to knowledge about brain biomarkers and imaging of ICANS, which will greatly aid in ICANS detection and prevention.


Eligibility criteria: Inclusion Criteria:

* Subjects must be ≥ 18 years of age at signing of informed consent.
* Subjects are scheduled to receive CAR T-cell treatment.

Exclusion Criteria:

* Refusal to sign the informed consent
* Subjects having previously been treated with CAR-T therapy.
* Subjects with clinically significant active bleeding, history of intracranial bleeding, or is at risk for intracranial bleeding
* Subjects presenting primary CNS lymphoma
* Pacemaker or other implanted electrical device incompatible with the MR environment
* Subjects with a neurodegenerative disease (PD, AD)
* Subjects with a previous or evolving neurological pathology
* Pregnant or breastfeeding women

Primary outcomes:
measure: Incidence of CAR-T-associated Neurotoxicity
timeFrame: up to 3 years post CAR T-cell infusion
Secondary outcomes:
measure: To identify biomarkers for ICANS
timeFrame: up to 1 years post CAR T-cell infusion
measure: MRI scans for ICANS
timeFrame: up to 1 years post CAR T-cell infusion
Other outcomes:
Locations:
city: Shijia Zhuang
country: China
facility: 980th Hospital
state: Hebei
Study officials:
affiliation: 980th Hospital
name: Shoulong Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02331992: Positive Airway Pressure Program
Official title: Positive Airway Pressure Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea, Obstructive
Keywords: Continuous Positive Airway Pressure
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2015-01-06
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Obstructive Sleep Apnea (OSA) is a common sleep disordered breathing condition effecting around 2-4% of the middle aged population and is characterized by periodic collapse of the upper airway during sleep. Continuous Positive Airway Pressure (CPAP) is the primary treatment for patients with OSA. Despite the effectiveness of CPAP in abolishing upper airway obstruction, acceptance of and adherence with therapy has been sub-optimal.

Over the past decade, considerable research has focused on determining the factors responsible for poor CPAP adherence. Two key areas have been identified: patient-reported symptoms, including mask discomfort, pressure intolerance and nasal symptoms and the importance of patient education and support. In addition we know that the patient experience during the crucial first days and weeks of their journey predicts longer term adherence.

This study investigates the ability of an automated program that assists patients towards continuous positive airway pressure (CPAP) therapy adherence.


Eligibility criteria: Inclusion Criteria:

* ≥ 18years of age
* Diagnosed with OSA (AHI \>5 events/hour) and eligible for CPAP (fixed or auto) treatment under local requirements
* Naïve to CPAP therapy, i.e. have not been prescribed CPAP in the past 5 years
* Own a mobile phone, and has reliable mobile network coverage at their home.
* Either: the participant will use a modem; OR the participant has access to a home internet connection (either their own, or a neighbours or friend etc) and is willing to perform a home upload.

Exclusion Criteria:

* Contraindicated for CPAP therapy
* Medically unstable condition/diagnosis that is not yet under control
* Co-existing sleep disorder (however clinically diagnosed insomnia can be included in the study)
* Periodic Limb Movement Arousal Index (PLMA) greater than 15/hr during the diagnostic study

Primary outcomes:
measure: Participant Providing Feedback
timeFrame: 1 month
Secondary outcomes:
measure: Healthcare Provider Feedback
timeFrame: 1 month
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Alabama Sleep Clinic
state: Alabama
city: Belleville
country: United States
facility: IV Care & Respiratory
state: Illinois
city: Columbia
country: United States
facility: SleepMed of South Carolina
state: South Carolina
Study officials:
affiliation: Fisher & Paykel Healthcare
name: Hamish Collie, MHlthSc
role: STUDY_CHAIR
References:
Clinical trial NCT02086292: The Influence of Lidocaine Volume on Discomfort During Administration of Local Anesthetic
Official title: The Influence of Lidocaine Volume on Discomfort During Administration of Local Anesthetic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Needlestick Injuries
Keywords: Injections
Lidocaine
Pain
Healthy volunteers
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2014-03-13
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the study is to find a simple method for pain reduction that can be used in clinical practice when administering digital nerve block with a single subcutaneous injection. It will be investigated whether a smaller volume of lidocaine can decrease pain during injection.

Detailed description: Healthy volunteers will receive a single subcutaneous injection digital nerve block at the base of each ring finger. 2ml 1% lidocaine in one of the fingers, and 1 ml 2% lidocaine in the other. After each injection, the subject will be asked to evaluate the pain on a visual analog scale (0-100 mm). Additionally the sensibility will be tested with a Semmes-Weinstein monofilament, to evaluate if the different methods achieve desired anesthetic effect.

Eligibility criteria: Inclusion Criteria:

* age 18 - 65

Exclusion Criteria:

* regular use of analgesics
* known hypersensitivity of local anaesthetic
* renal-, heart- or liver disease
* known peripheral neuropathy or diabetes mellitus
* local infection on injection site
* circulation disorders in upper extremities (e.g. Raynaud´s phenomenon)

Primary outcomes:
measure: pain
timeFrame: 60 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Department of neuroscience, NTNU
Study officials:
affiliation: Norwegian University of Science and Technology
name: Vilhjalmur Finsen, prof md
role: STUDY_DIRECTOR
References:
citation: Ballo S, Hjelseng T, Tangen LF, Lundbom JS, Skarsvag T, Finsen V. The Influence of Injected Volume on Discomfort During Administration of Digital Block. J Hand Surg Asian Pac Vol. 2016 Oct;21(3):369-73. doi: 10.1142/S2424835516500363.
Clinical trial NCT00313092: Obstructive Sleep Apnea Syndrome in Glaucoma
Official title: Does Plasma Matrix-metalloproteinase Activity Predict Glaucomas in Patients With OSAS (Obstructive Sleep Apnea Syndrome) and Does the Level of Plasma Matrix-metalloproteinase Activity Decrease After One Month of nCPAP-treatment
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obstructive Sleep Apnea Syndrome
Glaucoma
Keywords: OSAS
glaucoma
MMP
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University Hospital, Basel, Switzerland
First posted: 2006-04-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with sleep apnoe syndrom

Brief summary: The aim of the study is to determine if plasma matrix-metalloproteinase activity can predict glaucoma in patients with OSAS and if the level of plasma matrix-metalloproteinase activity will decrease after one month of nCPAP-treatment.

Detailed description: Glaucoma is a leading cause of blindness world-wide. Chronic primary open-angle glaucoma is the most common form among Caucasian patients. The key feature of glaucoma is damage to the optic nerve head, which is not necessarily related to an increased intraocular pressure. The prevalence of glaucoma among the patients with sleep apnoea was 7,2%: normal-tension glaucoma 2,9%, primary open-angle glaucoma 4,3%. The prevalence of obstructive sleep apnoea syndrome (OSAS) is around 4-10% for men and 2-4% for women. Matrix metalloproteinases (MMPs) substrates include essentially all extracellular matrix components as well as a wide array of molecules involved in intracellular adhesion, cell-matrix interaction, and cell signalling. However, MMPs effects are not restricted to extracellular matrix degradation. The prevalence of increased MMP in patients with OSAS and its predicting value for an additional glaucoma are not known. Further, we do not know if treatment of OSAS with nasal continuous positive air pressure(nCPAP) can decrease the MMP activity. With this study, we want to determine the prevalence of MMP activity and the prevalence of glaucoma in patients with OSAS. Further, we want to investigate if a nCPAP treatment period of four weeks decreases the MMP activity.

Eligibility criteria: Inclusion Criteria:

* OSAS planned begin of a nCPAP treatment

Exclusion Criteria:

* Current malignancy
* Oral steroids

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Eye Clinic
state: BS
Study officials:
affiliation: University Eye Clinic Basel
name: Selim Orgül, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06192992: Regional Blood Flow During Peripheral Heating
Official title: Regional Blood Flow During Peripheral Heating
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blood Flow
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Blood flow through the popliteal, brachial, and carotid arteries during peripheral heating of the feet


Eligibility criteria: Inclusion Criteria:

* between 18 and 65 years

Exclusion Criteria:

* open wounds on feet or legs

Primary outcomes:
measure: Blood flow through the popliteal, brachial, and carotid arteries
timeFrame: 30 minute
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Jeff Moore
state: California
Study officials:
References:
Clinical trial NCT01269892: Early Administration of Lactose-free Milk in Children Presenting With Acute Diarrhea
Official title: Study of Nutritional Regime for Acute Diarrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Diarrhea
Keywords: diarrhea, lactose, milk, weight, acute.
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-01-04
Enrollment: 74
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine which nutritional regime is better for acute diarrhea in outcomes.

Detailed description: Diarrhea is still the most important cause of mortality and morbidity in children of the developing countries. We evaluated the effectiveness of early administration of lactose free milk in the management of acute diarrhea in children below two years old.

Eligibility criteria: Inclusion Criteria:

1. children with acute non-bloody diarrhea (≤ 2 weeks)
2. mild to moderate dehydration

Exclusion Criteria:

1. mucous bloody stools
2. major systemic illness
3. severe malnutrition (Weight for age \<60% and Weight for height \<70 %)
4. history of antibiotics receiving

Primary outcomes:
measure: duration of diarrhea
timeFrame: at seven days after admission
Secondary outcomes:
measure: changes in weight gaining
timeFrame: at seven days after admission
Other outcomes:
Locations:
city: Isfahan
country: Iran, Islamic Republic of
facility: Al-zahra university hospital
Study officials:
affiliation: MD,research comittee
name: Ali Gholamrezaei, MD
role: STUDY_CHAIR
References:
Clinical trial NCT02495792: Using Real Time Biofeedback to Alter Running Mechanics
Official title: Using Real Time Biofeedback to Alter Running Biomechanics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Keller Army Community Hospital
Sponsor class: FED
First posted: 2015-07-13
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purposes of this study are 1) to assess foot strike patterns initially, at six months and at one year between two groups of runners attempting to transition to a non-rearfoot strike pattern (NRFS) with and without the use of biofeedback technology, and 2) to prospectively compare injury incidence rates at one year between NRFS and rearfoot strike (RFS) runners.


Eligibility criteria: Inclusion Criteria:

1. Between the age of 18 - 50 years
2. Run on average 12mi per week
3. DOD beneficiaries who intend to remain at West Point, NY for the next 12 months at time of study enrollment
4. Read and speak English well enough to provide informed consent and follow study instructions

Exclusion Criteria:

1. Known pregnancy currently or in the previous 6 months
2. Lower extremity or low back pain in the previous 3 months
3. Lower extremity or low back surgery in the previous 6 months
4. Any lower extremity or low back exercise limiting profile
5. Previous stress fracture of the foot
6. Participant who has a non-rearfoot strike running pattern

Primary outcomes:
measure: Change in Foot Strike Pattern From Baseline
timeFrame: Immediately post-training, 6mo post-training, and 1yr post-training
Secondary outcomes:
measure: Injury Incidence Between Foot Strike Patterns
timeFrame: 1yr
measure: Relative Risk of Injury
timeFrame: 1yr
Other outcomes:
Locations:
Study officials:
affiliation: Keller Army Community Hospital
name: Jamie B Morris, DPT
role: PRINCIPAL_INVESTIGATOR
References: