louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06338787: A Novel Iron-Based Supplement for Athletes Aged 14-17
Official title: Novel Iron-Based Supplement for Active Young Women With Sub-Optimal Iron
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Iron Deficiencies
Keywords: iron
microbiota
exercise
Lead sponsor: University of Calgary
Sponsor class: OTHER
Collaborators: name: Mitacs
name: Natural Sciences and Engineering Research Council, Canada
First posted: 2024-04-01
Enrollment: 30
Sex: FEMALE
Minimum age (years): 14
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Female endurance athletes are susceptible to iron deficiency and this can impact their exercise performance. This study aims to assess the efficacy of a novel iron supplement in improving iron status, gut microbiome, and exercise performance in endurance-trained females.

Detailed description: Current iron supplements on the market are commonly associated with side effects including gastrointestinal distress, nausea, vomiting, and constipation. As a solution, the investigators have developed a novel delivery system for iron supplementation that overcomes many of these limitations. The goal of this study is to assess the efficacy of a yeast-iron complex in improving iron status, gut microbiome, and exercise performance in endurance-trained adolescent females (aged 14-17) with sub-optimal iron status. Participants will consume 40mg of elemental iron every second day for 8 weeks. Before and after supplementation, participants will be assessed for exercise capacity (VO2max), iron status, and the current state of the gut microbiome. each week during supplementation, participants will complete a survey in which they will report feelings of stress and recovery as well as gastrointestinal symptoms.

Eligibility criteria: Inclusion Criteria:

* cis-gendered female 14-18 years old
* sub-optimal iron status (ferritin ≤45mcg/ L)
* At least 1 year past the age of menarche
* Engage in moderate to vigorous endurance activity for at least 3 hours a week

Exclusion Criteria:

* Supplemented with iron iron (\>5mg/day), prebiotics, or probiotics in last 3 months
* antibiotic use in last 3 months
* - Energy availability \>30 kcal/kg lean body mass

Primary outcomes:
measure: Iron Status
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Hemoglobin
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Lower Gut microbiome
timeFrame: Baseline, 4 weeks, 8 weeks
Secondary outcomes:
measure: Exercise Capacity
timeFrame: Baseline, 4 weeks, 8 weeks
Other outcomes:
measure: Gastrointestinal Symptoms 1
timeFrame: Weekly for 8 weeks
measure: Gastrointestinal Symptoms 2
timeFrame: Weekly for 8 weeks
measure: Sleepiness
timeFrame: Weekly for 8 weeks
measure: Stress and Recovery
timeFrame: Weekly for 8 weeks
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Jane Shearer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04625387: Dry Needle In Management of Cervicogenic Headache
Official title: Efficacy of Dry Needle With Exercise In Cervicogenic Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervicogenic Headache
Keywords: Dry Needle
Exercise
Neck pain
Trigger point
Lead sponsor: Raj Nursing and Paramedical College
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Headache is an important health problem. It is the commonest type of all signs of illness in the people worldwide. Cervicogenic Headache is commonest musculoskeletal condition in physiotherapy practice. This study's main objective was to evaluate effectiveness of Dry Needle with exercise in decreasing pain and improving function in patients with Cervicogenic Headache.

Detailed description: 50 patients were included and assigned randomly to group A and B. Group-A received Dry Needle plus exercise and group-B received Dry Needle alone. Baseline assessment was taken before and after treatment; treatment was given for four weeks twice a week. Outcome indicators were measured by Visual analog scale, Neck Disability Index and Cervical Range Of Motion.

The study findings indicate that both groups improve the symptoms of a headache. Clinically better improvement was indicated by Dry Needle plus exercise group than Dry Needle alone group. As per our results, Dry Needle plus exercise should be preferred for the management of cervicogenic headache over Dry Needle alone.

Eligibility criteria: Inclusion Criteria:

* Age between 20-50 years.
* Male and female both gender
* Worker in the Office.
* Employed permanently.
* Self-motivated for working continuously for rehab.
* Persistent or regular pain in the neck over a span of at least 6 months.

Exclusion Criteria:

* Cervical spine injury or surgery.
* Congenital spinal deformity.
* Participants having age less than 20 or elder than 50 years.
* Cervical radiculopathy,
* The participants had experienced any recent trauma or suffering from dizzy spells, any vascular neurological disorders.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: four weeks
measure: Neck Disability Index
timeFrame: four weeks
Secondary outcomes:
measure: Cervical Range of Motion
timeFrame: four weeks
Other outcomes:
Locations:
city: Gorakhpur
country: India
facility: Sharick Shamsi
state: Uttar Pradesh
Study officials:
affiliation: Raj Nursing and Paramedical College
name: Sharick Shamsi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05348187: Clinical Performance Study Protocol for Therascreen® KRAS RGQ PCR Kit
Official title: An Interventional, Prospective Clinical Performance Study Protocol, for the Testing of DNA Extracted From Tumor Tissue Biopsy Samples, Using the Therascreen® KRAS RGQ PCR Kit, From Patients With Non-Small Cell Lung Cancer and Colorectal Cancer, Screened in Amgen's Clinical Trial (Protocol No. 20170543).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Non-Small Cell Lung Cancer
Colorectal Cancer
Lead sponsor: QIAGEN Gaithersburg, Inc
Sponsor class: INDUSTRY
Collaborators: name: Amgen
First posted: 2022-04-27
Enrollment: 309
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: An interventional, prospective clinical performance study protocol, for the testing of DNA extracted from tumor tissue biopsy samples, using the therascreen® KRAS RGQ PCR Kit, from patients with Non-Small Cell Lung Cancer and Colorectal Cancer, screened in Amgen's clinical trial (Protocol No. 20170543).

Detailed description: This is an interventional, prospective clinical performance study protocol, for the testing of DNA extracted from tumor tissue biopsy samples (either core needle (NSCLC only) or excisional biopsies), obtained from patients with Non-Small Cell Lung Cancer (NSCLC) and Colorectal Cancer (CRC), using the therascreen® KRAS RGQ PCR Kit, (hereafter referred to as KRAS Kit).

Up to 280 patient tissue samples (from approximately 100 clinical study sites), obtained in the Amgen Clinical Protocol 20170543 study, will be tested using the KRAS Kit. The testing will be performed at the investigational device clinical testing site, NeoGenomics Laboratories, Inc., 7256 S. Sam Houston Pkwy W., Suite 300, Houston, Texas, 77085, USA.

The primary objective of the Amgen Clinical Study is to evaluate tumor objective response rate (ORR) assessed by MODIFIED RECIST 1.1 criteria of AMG 510 as a monotherapy in patients using the Clinical Trial Assay, therascreen® KRAS RGQ PCR Kit to assess whether to treat patients with KRAS G12C mutated advanced tumors (NSCLC and CRC).

The clinical data from the study will be used to determine the drug-device efficacy to support future regulatory submissions for the device-drug combination.

Eligibility criteria: Inclusion Criteria:

* All patients who provided consent (by signing and dating the Consent Form for Amgen Protocol No. 20170543), may be included in the device study.

Exclusion Criteria:

* Patients whose tumor tissue biopsy samples are not Clinical Trial Assay evaluable will be excluded from the study. Additionally, patients with samples identified for the study which have insufficient testing material will also be excluded, as will specimens which have undergone decalcification.

Primary outcomes:
measure: therascreen® KRAS RGQ PCR Kit
timeFrame: 5 business days
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: QIAGEN Gaithersburg, Inc
Study officials:
References:
Clinical trial NCT03810287: The Use Of Domperidone For The Relief Of Refractory Upper Gastrointestinal GI Symptoms
Official title: The Use Of Domperidone For The Relief Of Refractory Upper Gastrointestinal GI Symptoms
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Gastroparesis
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2019-01-18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To prescribe oral domperidone for patients with upper GI symptoms who have failed or suffered adverse effects from standard medical therapy.

Detailed description: The primary objective of this study is to prescribe oral domperidone for patients with upper GI symptoms who have failed or suffered adverse effects from standard medical therapy

Eligibility criteria: Inclusion Criteria:

1. Males or females who are 18 years of age or older
2. Symptoms or manifestations secondary to Gastro esophageal reflux disease (GERD) (e.g., persistent esophagitis, heartburn, upper airway signs or symptoms or respiratory symptoms), gastrointestinal motility disorders such as nausea, vomiting, severe dyspepsia or severe chronic constipation that are refractory to standard therapy.

Exclusion Criteria:

1. i. History of, or current, arrhythmias including ventricular tachycardia, ventricular fibrillation and Torsade des Pointes. Patients with minor forms of ectopy (PACs) are not necessarily excluded.

   ii. Clinically significant bradycardia, sinus node dysfunction, or heart block.

   iii. Prolonged QTc (QTc\>450 milliseconds for males, QTc\>470 milliseconds for females)

   iv. Clinically significant electrolyte disorders.
2. Gastrointestinal hemorrhage or obstruction.
3. Presence of a prolactinoma (prolactin-releasing pituitary tumor).
4. Pregnant or breast feedings female.
5. Known allergy to domperidone

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Digestive Diseases
state: Connecticut
Study officials:
affiliation: Yale University
name: Jill Deutsch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01884987: Treatment of Cerebral Radiation Necrosis With GM1, a Prospective Study
Official title: Phase II Study of Monosialotetrahexosylganglioside for Cerebral Radiation Necrosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Radiotherapy
Nasopharyngeal Carcinoma
Cerebral Radiation Necrosis
MRI
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2013-06-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients must have undergone definitive RT for histologically confirmed NPC years before. They were required to have at least two consecutive magnetic resonance imaging (MRI) study supporting the diagnosis of CRN with an interval of 3-4 months, with the second MRI showing progressive disease compared with the first MRI. The necrotic mass shown on MRI must be measured in two dimensions in order to define the response to treatment. Other radiologic studies were also required to support the non-existence of local or regional recurrence, distant metastasis. Patients must have undergone mental status examinations and had progressive neurologic symptoms or signs. In addition, they were required to have a Karnofsky performance status of at least 70 and were supposed to live more than 6 months.

Brief summary: Cerebral radiation necrosis (CRN) is a well-documented late complication of radiation therapy for cancers, and may have a devastating effect on the patient's quality of life (QOL). However,CRN was once regarded as a progressive and irreversible disease, no standard therapy has been suggested for CRN. In our clinical practice, we have used monosialotetrahexosylganglioside (GM1)to treat CRN, and found that GM1 can successfully reverse CRN. So we carried out this prospective study to test the efficacy of GM1 for CRN.


Eligibility criteria: Inclusion Criteria:

The necrotic mass shown on MRI must be measured in two dimensions. No local or regional recurrence, no distant metastasis. Karnofsky performance status of at least 70 and were supposed to live more than 6 months.

Exclusion Criteria:

* CRN combined with local or regional relapse, or with distant metastasis. ② CRN combined with other cerebrovascular disease. ③CRN combined with the second primary malignancy. ④ CRN without neurologic symptoms or signs. ⑤ CRN combined with diabetes. ⑥CRN patients that were supposed to live less than 6 months.

Primary outcomes:
measure: The necrotic volume showed on MRI
timeFrame: 6-8 months
Secondary outcomes:
measure: relief of the symptoms related to CRN
timeFrame: 6-8 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Cancer Center, Fudan University
Study officials:
affiliation: Fudan University
name: ChaoSu Hu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02648087: Prevalence of Sleep-disordered Breathing in Patients With a Newly Diagnosed Non Small Cell Lung Cancer
Official title: Prevalence of Sleep-disordered Breathing in Patients With a Newly Diagnosed Non Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bronchial Cancer
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2016-01-06
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: There is a possible implication of sleep apnea syndrome via night-time intermittent hypoxemia in perturbation of quality of life and tumour progression to patients with a bronchial cancer.

The aim of the study is to evaluate this possibility with the help of a night record of sleep and quality of life questionnaires.

Detailed description: There is a possible implication of sleep apnea syndrome via night-time intermittent hypoxemia in perturbation of quality of life and tumour progression to patients with a bronchial cancer.

Enrollment 1200 patients This wide sample is expected to respond to the main and secondary objectives of the study

Eligibility criteria: Inclusion Criteria:

* patients with NSCLC undergoing diagnostic
* Performance status 0,1,2

Exclusion Criteria:

* \>75 years
* OSA known and in the last 12 months treated PS \>2
* Patients under a long-term oxygen therapy
* persons deprived of liberty by judicial decision.
* \<18 years

Primary outcomes:
measure: Oxygen desaturation index
timeFrame: Between day 1 and day 15
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01037387: Effect of Noninvasive Ventilation on Physical Activity and Inflammation in COPD Patients
Official title: Effect of the Noninvasive Mechanical Ventilation on the Daily Physical Activity and the Inflammatory Biomarkers in Stable Patients With COPD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Hypercapnic
Lead sponsor: Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2009-12-23
Enrollment: 50
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Parallel, randomized and controlled clinical trial to evaluate the effect of 12 months of noninvasive mechanical ventilation versus conventional treatment in hypercapnic patients with stable COPD.

Main objective: To evaluate the effect of 12 months of noninvasive ventilation on c-reactive protein concentration and daily physical activity in hypercapnic patients with stable COPD.

Secondary objectives: To compare the plasmatic concentration of other inflammatory biomarkers between COPD patients with conventional treatment and wich noninvasive ventilation. To determine the response of breathlessness, health-related quality of life and lung function to noninvasive ventilation. To identify the COPD patients with a higher gasometric and clinic response to noninvasive ventilation.


Eligibility criteria: Inclusion Criteria:

* Age: 45-75 yrs.
* COPD diagnosis (postbronchodilator FEV1/FVC \< 0.7) for at least 6 months.
* FEV1 \< 45% predicted
* Baseline pH 7.35-7.45
* Baseline PaCO2\>45 mmHg breathing current air
* Smoking history (\>15 pack-year)
* Clinically stable for at least the last three months
* Pharmacological treatment optimized in the last two years.

Exclusion Criteria:

* Previous diagnosis of asthma, other airway obstructive disease, sleep apnea syndrome, interstitial lung disease, chest wall disease or neuromuscular disease.
* Apnea-hypopnea index \> 10/h
* Morbid obesity (BMI \> 45 Kg/m2)
* Previous diagnosis of ischaemic heart disease, cardiac failure, cirrhosis, chronic renal failure, rheumatoid arthritis or other inflammatory disease.

Primary outcomes:
measure: daily physical activity and plasmatic concentration of C-reactive protein
timeFrame: 12 months
Secondary outcomes:
measure: Seric concentrations of homocysteine, proBNP, fibrinogen, cholesterol, tg, tnf-alpha, IL-1, IL-6 and 8-isoprostane
timeFrame: 12 months
measure: PaO2, PaCO2, pH, IC, VCIN, FVC, FEV1, FEV1/FVC, TLC, FRC/TLC, RV/TLC,PImax, PEmax, TTmus, 6MWD
timeFrame: 12 months
measure: BDI/TDI, SF-36, SGRQ, LCADL
timeFrame: 12 months
measure: Adverse effects
timeFrame: 12 months
measure: Cardiovascular effects, exacerbations, hospitalizations and mortality
timeFrame: 12 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
Study officials:
affiliation: Hospital Universitario La Paz
name: Maria Antonia Gómez-Mendieta
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03359187: Prevention of Mucositis in Patients With Head and Neck Cancer Treated With Radiotherapy
Official title: Prevention of Radiation-induced Mucositis in Patients With Head and Neck Cancer Treated With Radiotherapy : A Double-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiation- Induced Mucositis
Adverse Effect of Radiation Therapy
Head and Neck Cancer
Keywords: Radiation- induced mucositis
Head and Neck Cancer
Radiation therapy side effect
Lead sponsor: Chulabhorn Hospital
Sponsor class: OTHER
First posted: 2017-12-02
Enrollment: 120
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental design in 3 groups
Primary purpose: PREVENTION

Brief summary: Prevention of radiation-induced mucositis in patients with head and neck cancer treated with radiotherapy : A Double-blind Randomized Controlled Trial

Detailed description: To compare the effect of each herb extracts in form of mouth wash to protect or delay the onset of the radiation-induced mucositis from the adverse effects of radiation therapy in patients with head and neck cancer.

Eligibility criteria: Inclusion Criteria:

* Aged 15 years old or older,
* Diagnosed with Head and Neck cancer
* On treatment of external Radiation therapy

Exclusion Criteria:

* Pregnant
* Previously underwent external Radiation therapy
* Illiterate

Primary outcomes:
measure: Change of mucositis grading
timeFrame: Change from baseline mucositis grading 1,2, 3, 4, 5 , 6 , 7, 8, 9 week and at 1 month after completed Radiation therapy
Secondary outcomes:
measure: Patient satisfaction with the mouth wash
timeFrame: The last fraction of radiation therapy, through study completion, an average of 1 year
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Chulabhorn Hospital
Study officials:
References:
citation: Kongwattanakul S, Petchann N, Petroch P, Thanthong S, Tungfung S, Chamchod S, Pitiporn S, Nantajit D. Prophylactic management of radiation-induced mucositis using herbal mouthwash in patients with head and neck cancer: an assessor-blinded randomized controlled trial. J Complement Integr Med. 2022 Feb 28;19(3):771-780. doi: 10.1515/jcim-2021-0457. eCollection 2022 Sep 1.
Clinical trial NCT04210687: Trapeziectomy vs. Trapeziometacarpal Limited Excision for Thumb Base Osteoarthritis
Official title: A Randomized Comparison Between Trapeziectomy and Trapeziometacarpal Limited Excision for Thumb Base Osteoarthritis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Thumb Osteoarthritis
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2019-12-26
Enrollment: 90
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: A randomized comparison between trapeziectomy and trapeziometacarpal limited excision for thumb base osteoarthritis in 90 patients.


Eligibility criteria: Inclusion Criteria:

* Painful osteoarthritis in the thumb base and radiological arthritis (Eaton Littler class 2-3) and clinical signs of thumb base osteoarthritis (pain at palpation of the thumb base joint and pain during grinding test).
* Pain at rest.
* Conservative treatment \>6 months (activity modification, splinting, painkillers or thumb base steroid or PRP injection)

Exclusion Criteria:

* Rheumatoid arthritis.
* Ongoing infection in the hand or wrist. -
* History of gout or pseudo gout.
* Inability to co-operate with the follow-up protocol (language difficulties, severe psychiatric disorder, cognitive impairment, drug addiction).
* Intra-articular injection in the affected joint within 6 months.
* Eaton Littler class 4 (STT joint involved).

Primary outcomes:
measure: Change in pain on load NRS (numerical rating scale)
timeFrame: Preoperatively, 1, 3 and 5 years postoperatively
Secondary outcomes:
measure: Change in Nelson Thumb score
timeFrame: Preoperatively, 1, 3 and 5 years postoperatively
measure: Change in EQ-5D
timeFrame: 1, 3 and 5 years postoperatively
measure: Change in DASH - Disability of the Arm, Shoulder and Hand
timeFrame: Preoperatively, 1, 3 and 5 years postoperatively
measure: Change in PRWHE - Patient-Rated Wrist and Hand Evaluation
timeFrame: Preoperatively, 1, 3 and 5 years postoperatively
measure: Change in HADS - Change hospital Anxiety and Depression score
timeFrame: Preoperatively, 1, 3 and 5 years postoperatively
measure: Change in PCS - Pain Catastrophizing Score
timeFrame: Preoperatively, 1, 3 and 5 years postoperatively
measure: Change in Thumb base motion
timeFrame: Preoperatively, 1, 3 and 5 years postoperatively
measure: Change in thumb strength
timeFrame: Preoperatively, 1, 3 and 5 years postoperatively
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet
Study officials:
affiliation: Karolinska Instituet
name: Maria Wilcke, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: