louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04342429: Prospective Study of Intensity-Modulated Proton Therapy (IMPT) for Small Cell Lung Cancer
Official title: RAD4649-19: Prospective Study of Intensity-Modulated Proton Therapy (IMPT) for Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Small-cell Lung Cancer
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the safety and efficacy of intensity-modulated proton therapy (IMPT) for small cell lung cancer (SCLC)

Detailed description: To determine the optimal schedule for three-dimensional verification imaging and necessary re-planning of patients undergoing IMPT for a rapidly changing tumor (small cell lung cancer).

* To determine the rate of cardiac toxicities from IMPT in patients with small cell lung cancer compared with historical controls receiving photon-based treatment.
* To determine the rate of pneumonitis and esophagitis from IMPT and compare with historical controls receiving photon based treatment.

Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed small cell lung cancer, limited or extensive stage.
* Patients who are offered thoracic radiotherapy with intensity-modulated proton therapy (IMPT) techniques delivering 30-66 Gy in 15-33 fractions at 2 Gy per fraction, at the recommendation of the treating radiation oncologist.
* Age 18 or greater

Exclusion Criteria:

* Prior radiation therapy which would provide significant dose overlap with the planned target volume(s)
* Pregnancy

Primary outcomes:
measure: Patients with small cell lung cancer (SCLC) will be assessed with the intensity-modulated proton therapy (IMPT).
timeFrame: Up to 1 year from study start
measure: Determination of the optimal frequency of conebeam CT during treatment and subsequent need for adaptive re-planning
timeFrame: Up to 1,2, and 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University-Winship Cancer Institute
name: Kristin Higgins, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05184829: A Single-center Study on the Effect of Systemic/Selective Lymph Node Dissection on the Prognosis of Ground Glass Nodules Smaller Than 3cm and With Components With Consolidation/Tumor Ratio Between 0.5-1
Official title: A Single-center Study on the Effect of Systemic/Selective Lymph Node Dissection on the Prognosis of Ground Glass Nodules Smaller Than 3cm and With Components With Consolidation/Tumor Ratio Between 0.5-1
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Progression
Postoperative Recovery
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 500
Sex: ALL
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: systemic or selective lymph node dissection group
Primary purpose: OTHER

Brief summary: A single-center study on the effect of systemic/selective lymph node dissection on the prognosis of ground glass nodules smaller than 3cm and with components with consolidation/tumor ratio between 0.5-1

Detailed description: A single-center study on the effect of systemic/selective lymph node dissection on the prognosis of ground glass nodules smaller than 3cm and with components with consolidation/tumor ratio between 0.5-1

Eligibility criteria: Inclusion Criteria:

Patients enrolled in the study must meet all of the following conditions:

* 1.Aged between 25 and 75 years;
* 2. GGO is diagnosed by thin-section lung CT (thickness \<1.5mm) within one month before surgery;
* 3. The maximum diameter of the GGO is smaller than 3cm;
* 4. The solid component in GGO between 50%-100%;
* 5. Preoperative examination showed that the patient could tolerate lobectomy;
* 6. The patient is able to understand and comply with the study and has provided written informed consent.

Exclusion Criteria:

Patients meeting any of the following criteria are not eligible for this trial:

* 1. Patients with a history of lung surgery;
* 2. Postoperative pathology showed non-primary lung cancer;
* 3. The scope of surgical resection is larger than one lung lobe;
* 4. Patients with a history of other tumors;
* 5. Patients with severe complications (coronary heart disease, valvular heart disease, end-stage renal disease, severe liver cirrhosis);
* 6. Unable to cooperate with the researchers because of dementia or cognitive decline
* 7. Other situations that are not in conformity with the standards and requirements of this trial.

Primary outcomes:
measure: Overall survival
timeFrame: From enrollment to 36 months after surgery
Secondary outcomes:
measure: Complications
timeFrame: 1-2 Weeks after enrollment (after Surgery)
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00727129: Study to Evaluate Divigel for the Treatment of Postmenoupausal Symptoms
Official title: Placebo-Controlled, Randomized, Double-Blind, Multicenter Study, to Demonstrate the Efficacy of 12 Weeks of Treatment With USL-221 on Moderate to Severe Vasomotor Symptoms and Vulvar/Vaginal Atrophy in Postmenopausal Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postmenopausal Symptoms
Keywords: vasomotor symptoms
estrogen
estradiol
hot flashes
Lead sponsor: Upsher-Smith Laboratories
Sponsor class: INDUSTRY
First posted: 2008-08-01
Enrollment: 495
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the safety and efficacy of USL-221 to placebo for postmenopausal patients.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women
* Have moderate to severe hot flashes
* Normal Pap Smear

Exclusion Criteria:

* Abnormal mammogram
* Abnormal clinical breast exam
* BMI \>35

Primary outcomes:
measure: Daily frequency and severity of moderate to severe vasomotor symptoms
Secondary outcomes:
measure: vulvar and vaginal atrophy
Other outcomes:
Locations:
Study officials:
References:
citation: Hedrick RE. Low-dose estradiol gel 0.1% for the treatment of vasomotor symptoms associated with menopause. Expert Review of Obstetrics & Gynecology, 3(2): Pages 155-162, Mar 2008.
Clinical trial NCT04744129: Headache Inducing Effect of NN414 in Migraine Patients
Official title: NN414's Effect in Cerebral Hemodynamics and Headache Induction in Migraine Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Headache, Migraine
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: To investigate the role of KATP channels on the cerebral hemodynamic in migraine patients.


Eligibility criteria: Criteria

Inclusion Criteria:

* Migraine patients of both sexes.
* 18-60 years.
* 50-100 kg.
* Women of childbearing potential must use adequate contraception.

Exclusion Criteria:

* Headache less than 48 hours before the tests start
* Daily consumption of drugs of any kind other than oral contraceptives
* Pregnant or nursing women.
* Cardiovascular disease of any kind, including cerebrovascular diseases.
* Diabetes mellitus and other endocrinologic disease

Primary outcomes:
measure: Occurrence and change of migraine attack
timeFrame: Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline
Secondary outcomes:
measure: Change in cerebral hemodynamic
timeFrame: Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline
measure: Occurrence and change of headache
timeFrame: Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline
measure: Change of diameter of the artery
timeFrame: Before (-10 min) and after infusion (+2 hours) of NN414 compared with before and after infusion of saline
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Danish Headache Center
state: Capital Region
Study officials:
References:
Clinical trial NCT03619629: Ankle Kinesio Taping vs Mulligan's Mobilization With Movement
Official title: Comparison of the Effects of Kinesio Taping and Mulligan's Mobilization With Movement on Balance, Muscle Strength and Flexibility in Healthy Ankles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Kinesio-taping
Mulligan
Mobilization
balance
ankle
Lead sponsor: Dokuz Eylul University
Sponsor class: OTHER
First posted: 2018-08-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare the effects of Kinesio taping and Mulligan's mobilization with movement technique on balance, muscle strength and flexibility in healthy ankles . Patients will randomly be divided into 4 groups: Kinesio taping (KT) group, sham Kinesio taping (SKT) group, Mulligan's mobilization with movement (MWM) group and sham mobilization with movement (SMWM) group . Kinesiotape will be applied both ankles as "Correction technique" in KT group, 'Posterolateral glide mobilization with movement' will be applied 10 times to both ankles in MWM group. The evaluations will be repeated after waiting 45 minutes to reveal the effects of Kinesio taping and Mulligan mobilization with movement.


Eligibility criteria: Inclusion Criteria:

* Age between 18-35
* Healthy individuals
* Able to read, write and understand Turkish
* willing and able to attend study

Exclusion Criteria:

* Any neurological, musculoskeletal or vascular disease in any of the lower extremity.
* Previous history of surgery in any of the lower extremity.
* Mental and cognitive disorders that would seriously affect cooperation

Primary outcomes:
measure: change in balance
timeFrame: Before intervention and 45 minutes after the intervention
Secondary outcomes:
measure: change in muscle strength
timeFrame: Before intervention and 45 minutes after the intervention
measure: change in flexibility
timeFrame: Before intervention and 45 minutes after the intervention
measure: change in range of motion
timeFrame: Before intervention and 45 minutes after the intervention
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Dokuz Eylul University
Study officials:
References:
Clinical trial NCT03245229: A Study in Healthy Male Subjects to Investigate Whether Administration of ACT-132577 Can Affect Rosuvastatin's Fate in the Body (Amount and Time of Presence in the Blood)
Official title: A Single-center, Open-label, One-sequence, Two-treatment Study to Investigate the Effect of ACT-132577 at Steady State on the Pharmacokinetics of Rosuvastatin in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Idorsia Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2017-08-10
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The primary purpose of this study is to investigate the effect of Aprocitentan (ACT-132577) at steady state on the pharmacokinetics of single-dose rosuvastatin in healthy male subjects


Eligibility criteria: Inclusion Criteria:

* Signed informed consent in the local language prior to any study mandated procedure;
* Healthy male subjects aged 18 to 45 years (inclusive) at screening;
* Body mass index of 18.0 to 28.0 kg/m2 (inclusive) at screening;
* Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests;
* Hemoglobin ≥ 135 g/L at screening.

Exclusion Criteria:

* Known allergic reactions or hypersensitivity to ACT-132577, rosuvastatin, any drug of the same classes, or any of their excipients;
* Any contraindication for rosuvastatin treatment;
* History or clinical evidence of myopathy;
* Asian or Indian-Asian ethnicity;
* Known hypersensitivity or allergy to natural rubber latex;
* Previous exposure to ACT-132577;
* Treatment with rosuvastatin within 3 months prior to screening;
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.

Primary outcomes:
measure: Maximum plasma concentration (Cmax) of rosuvastatin
timeFrame: Up to Day 29
measure: Time to reach Cmax (tmax) of rosuvastatin
timeFrame: Up to Day 29
measure: Terminal half-life (t1/2) of rosuvastatin
timeFrame: Up to Day 29
measure: Area under the plasma concentration-time curves during a dosing interval [AUC(0-t)] of rosuvastatin
timeFrame: Up to Day 29
measure: Area under the plasma concentration-time curves from time 0 to inf [AUC(0-inf)] of rosuvastatin
timeFrame: Up to Day 29
measure: Trough (pre-dose) plasma concentrations (Ctrough) of ACT-132577
timeFrame: Up to Day 29
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to Day 29
measure: Changes from baseline in electrocardiogram (ECG) variables
timeFrame: Up to Day 29
measure: Changes from baseline in blood pressure
timeFrame: Up to Day 29
measure: Changes from baseline in pulse rate
timeFrame: Up to Day 29
Other outcomes:
Locations:
city: Plzen
country: Czechia
facility: Cepha s.r.o
Study officials:
affiliation: Idorsia Pharmaceuticals Ltd.
name: Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT01533129: The Effect of Testosterone Replacement on Endothelial Dysfunction, Inflammation and Insulin Resistance in Male Hypogonadotrophic Hypogonadism
Official title: Phase 4 Study That Evaluates the Effects of Two Different Testosterone Replacement Regiments on Endothelial Dysfunction, Inflammation and Insulin Resistance in Male Subjects With Hypogonadotrophic Hypogonadism.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypogonadotrophic Hypogonadism
Keywords: Hypogonadism
Endothelial dysfunction
Inflammation
Insulin resistance
Testosterone replacement therapy
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2012-02-15
Enrollment: 106
Sex: MALE
Minimum age (years): 18
Maximum age (years): 26
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study searched for answers to two questions

1. What is the effect of testosterone replacement therapy on endothelial dysfunction, inflammation and insulin resistance?
2. Regarding the above parameters, is there any difference between daily transdermal testosterone implementation and intramuscular injection performed in three weeks.


Eligibility criteria: Inclusion Criteria:

* Men
* Treatment naive
* Hypogonadotrophic hypogonadism

Exclusion Criteria:

* Previous history of androgen replacement
* Chronic metabolic disorders

Primary outcomes:
measure: The alterations in the measures for endothelial functions
timeFrame: 6 months
measure: The alterations in the measures of insulin resistance
timeFrame: 6 months
measure: The alterations in the measures of inflammation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Gulhane School of Medicine Department of Endocrinology and Metabolism
state: Non US
Study officials:
References:
Clinical trial NCT00716729: Development of Outcome-measures for Physically Active Patients With Hip and Groin Pain
Official title: Development of Outcome-measures for Physically Active Patients With Hip and Groin Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Disability
Groin Disability
Keywords: Questionnaire
Hip
Groin
Disability
Strength
To develop two new outcome measures for patients with hip and groin disability
Lead sponsor: Amager Hospital
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
First posted: 2008-07-16
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hip and/groin pain for more than 8 weeks

Brief summary: The aim of this study is to develop an evaluative questionnaire, to evaluate patients with hip and groin disability, and a strength measurement for the hip, for patients with hip and groin disability.

Both measurement instrument are aimed for evaluating the natural course and different treatment modalities in patients with hip and groin disability.


Eligibility criteria: Inclusion Criteria:

* Hip and/groin pain more than 6 weeks
* Physically active

Exclusion Criteria:

* Systemic diseases
* Physically inactive

Primary outcomes:
measure: Patient reported questionnaire
timeFrame: 1-2 years
Secondary outcomes:
measure: Strength measurement for the hip
timeFrame: 1 year
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Amager Hospital
state: Copenhagen S
Study officials:
References:
citation: Thorborg K, Holmich P, Christensen R, Petersen J, Roos EM. The Copenhagen Hip and Groin Outcome Score (HAGOS): development and validation according to the COSMIN checklist. Br J Sports Med. 2011 May;45(6):478-91. doi: 10.1136/bjsm.2010.080937.
Clinical trial NCT06948929: Synbiotic Formula (SCV09) in Alzheimer's Disease Patients
Official title: A Pilot, Single-arm Study on the Efficacy and Safety of the Use of a Synbiotic Formula (SCV09) in Alzheimer's Disease Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Alzheimer Disease
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In recent years, emerging studies have revealed the role of gut microbiota in human health and diseases, including AD and other neurodegenerative conditions5. Although the underlying mechanism is still largely unknown, successful therapies targeting the gut-brain axis may serve as indirect evidence of the possible linkage.

This pilot, single-arm study aims to estimate the efficacy and assess the safety profile of the use of a new synbiotic formula (SCV09) in improving dementia-related behaviour in Alzheimer's disease patients, paving the way for a large-scale randomised controlled trial in the future.


Eligibility criteria: Inclusion Criteria:

* Individuals aged between 60-85 with a clinical diagnosis of Alzheimer's disease
* Hong Kong version of Montreal Cognitive Assessment (HK-MoCA) score of ≤20
* Neuropsychiatric Inventory-Questionnaire (NPI-12) ≥10
* Stable medication history for Alzheimer's disease within the past 4 weeks
* Have been taken care by a responsible caregiver who could assist the patient in taking the study products, collecting stool samples and attending the clinical follow-up •-Able to provide informed consent

Exclusion Criteria:

* Concomitant Parkinson's disease and other neurodegenerative conditions affecting activities of daily living
* History of stroke
* History of severe organ failure (including decompensated cirrhosis), renal failure on dialysis, suffering from human immunodeficiency virus infection
* Confirmed active malignancy
* Known operations involving small intestines and large intestines; or history of appendectomy, hysterectomy, and cholecystectomy in last 6 months
* Use of anti-psychotics, antidepressants or sedatives, unless on a stable dose in the last 3 months
* Inability to receive oral fluids
* Use of antibiotics, probiotics or prebiotics in the last 2 weeks
* Intolerance to probiotics or lactose

Primary outcomes:
measure: Neuropsychiatric Inventory-Questionnaire
timeFrame: 6 months
Secondary outcomes:
measure: Activities of Daily Living
timeFrame: 6 months
measure: HK-MoCA
timeFrame: 6 months
measure: Gut microbiota composition and functions
timeFrame: 6 months
Other outcomes:
Locations:
city: Shatin
country: Hong Kong
facility: The Chinse University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Professor Timothy Kwok
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04913129: The Burden of COVID-19 Survivorship
Official title: The Burden of COVID-19 Survivorship: Exercise Therapy to Combat the Sequelae of COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 27
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study is being done to find out what the longer-term physiological consequences of COVID-19 are, and to determine if exercise therapy can help improve lung function, heart function and overall fitness, and reduce symptoms in people recovering from SARS-CoV-2.

Detailed description: The purpose of this research is to see if taking part in structured exercise training will improve the ability to exercise, the function of the lungs and the function of the heart, and reduce symptoms of fatigue and breathlessness in people recovering from COVID-19. After enrollment all patients will complete exercise testing, lung function testing, and cardiac imaging. Patients will be randomized to either 8 weeks of exercise training (4-5 times per week) or will continue standard medical care. All patients will undergo detailed exercise testing, lung function testing, and cardiac imaging after the intervention.

Eligibility criteria: Inclusion Criteria:

* Aged 21 to 75 years.
* History of RT-PCR proven SARS-CoV-2 infection.
* Deemed 'recovered' from SARS-CoV-2 infection.
* Not clinically obese (BMI ≥ 36) and/or suffer from musculoskeletal or other conditions that would limit exercise participation.
* No evidence of cardiac ischemia at rest or during exertion (via ECG).
* Able to provide written informed consent.

Exclusion Criteria:

* Individuals less than 21 or more than 75 years old.
* Not able to take part in structured exercise training due to injury or other conditions that would put person at risk during exercise.
* Unable to provide written informed consent.

Primary outcomes:
measure: Maximal oxygen update (VO2max) measured in mL/kg/min
timeFrame: 8 weeks
Secondary outcomes:
measure: Peak exercise work rate (Wpeak) measured in Watts
timeFrame: 8 weeks
measure: Forced vital capacity (FVC) measured in L
timeFrame: 8 weeks
measure: Forced expiratory volume in 1 second (FEV1) measured in L
timeFrame: 8 weeks
measure: Maximal inspiratory pressure (MIP) measured in cmH2O
timeFrame: 8 weeks
measure: Maximal expiratory pressure (MEP) measured in cmH2O
timeFrame: 8 weeks
measure: Left ventricular contractile function measured as % fractional area change (LV FAC)
timeFrame: 8 weeks
measure: Right ventricular contractile function measured as % fractional area change (RV FAC)
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Bryan Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
References: