louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05363670: Administration of ARS-1 or Albuterol in Subjects With Persistent Asthma
Official title: A Phase 2, Single-Dose, Randomized, Active and Placebo Controlled, Four-Period, Cross-Over Study of the Safety and Efficacy of Intranasal Epinephrine After Administration of ARS -1 or Albuterol in Subjects With Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Lead sponsor: ARS Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-06
Enrollment: 18
Sex: ALL
Minimum age (years): 12
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: ARS-1 is being developed for patients as a needleless alternative route of epinephrine administration for the management of refractory asthma symptoms.


Eligibility criteria: Inclusion Criteria:

* 1. Is a male or female subject between the ages of 12 and 65 years, inclusive.
* 2. Asthma that has been stable for at least four weeks prior to screening as defined by clinical history.
* 3. Reversible bronchoconstriction.
* 4. Has body weight more than 30 kilogram (kg) and body mass index between 18 and 34 kg/m², inclusive.
* 5. Has no medical history of hypertension and cardiovascular disease in the last 10 years.
* 6. At screening, has stable vital signs.

Exclusion Criteria:

* 1. History of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or cardiovascular disease or any other condition.
* 2. Patients receiving beta blocker.
* 3. Has any clinically significant medical condition or physical exam finding as deemed inappropriate by the Investigator.
* 4. Has abnormal cardiovascular exam at screening including any prior history of myocardial infarction or clinically significant abnormal electrocardiogram.
* 5. Has mucosal inflammatory disorders.
* 6. Has had significant traumatic injury, major surgery or open biopsy within 30 days prior to study screening.

Primary outcomes:
measure: Effect of ARS-1 versus Albuterol and placebo
timeFrame: From baseline (timepoints 0) to 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Chevy Chase
country: United States
facility: Institute for Asthma and Allergy
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Cincinnati
country: United States
facility: Bernstein Clinical Research Center, LLC
state: Ohio
Study officials:
affiliation: ARS Pharmaceuticals, Inc.
name: Sarina Tanimoto, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01281670: The Effects of Combining Whole Body Vibration Training With Plyometric Jumping on the Neuromuscular Adaptations of Human Triceps Surae Muscles
Official title: The Effects of Combining Whole Body Vibration Training With Plyometric Jumping on the Neuromuscular Adaptations of Human Triceps Surae Muscles
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Muscle Force, Explosive Strength and Vertical Jump Height
Keywords: H reflex; muscle activation; rate of force development; whole body vibration
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2011-01-24
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Muscle force, explosive strength and vertical jump height are important parameters determining the performance of athletes. Traditionally, high intensity resistance training, explosive strength training and plyometric training are used to improve athletes' performance. Recently, whole body vibration training is recommended for increasing muscle force and explosive strength, because vibrating platform could provide high gravitational acceleration to activate muscle activation and sensory input to spinal reflex. Design: Prospective and randomized control study. Subjects: Healthy male subjects with regular training or competition at least 6 hours per week. Methods: H-reflex, V-wave, triceps surae activation level and rate of force development are measured at pre-training, mid-training (5th week) and post-training. Subjects will receive 8 weeks, 3 times/week, training programs including plyometric jumping or static squat on whole body vibration platform. Data analysis: Data will be analyzed using SPSS 13.0 software (SPSS Inc., Chicago, IL) and two-way ANOVA will be used for data analysis.


Eligibility criteria: Inclusion Criteria:

* subjects who had not been engaged in systematic strength training and had no history of knee, leg, or ankle pain that caused a subject to seek medical help during the year prior to the recruitment.

Exclusion Criteria:

* Subjects who missed more than one training session or participated in any other type of fitness training were excluded.

Primary outcomes:
measure: evoked spinal reflex
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University
Study officials:
affiliation: National Taiwan University Hospital
name: Hsing-Kuo Wang, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05879770: Is the Use of Prolene as Sufficient as the Use of Wire in Shouldice Surgery to Keep the Recurrence Rate Low After One Year?
Official title: Is the Use of Prolene as Sufficient as the Use of Wire in Shouldice Surgery to Keep the Recurrence Rate Low After One Year?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inguinal Hernia
Keywords: Hernia, Shouldice Repair, groin hernia
Lead sponsor: Shouldice Hospital
Sponsor class: OTHER
First posted: 2023-05-30
Enrollment: 1400
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients of all sexes who have undergone inguinal hernia surgery in Shouldice technique.

Brief summary: When conducting the Shouldice procedure the 4-layer suture of the transversalis fascia is usually done with Prolene worldwide. At the Shouldice hospital the wire has originally been used for these augmentation. During the last decade several Shouldice Surgeons started to use the Prolene due to occasional delivery problems of the wire from Germany.

The 1-year- recurrence rate at the Shouldice hospital is 1,15% (mainly wire-use). The published 1-year recurrence rate in Europe is 2%.

As quality assessment, this project intends to evaluate these two options for suturing (wire vs Prolene) in the elective inguinal hernia patient in terms of 1-year recurrence rate. The population of focus will be those who had a primary or secondary inguinal hernia operation at Shouldice Hospital and the project is estimated to take 3 months.

Detailed description: a. Study design A total of 1400 patients (n=700 with wire; n=700 with Prolene) who underwent Shouldice surgery at Shouldice Hospital will be contacted by telephone. They will be asked whether a relapse occurred after their surgery.

Sample size calculation:

The 1-year recurrence rate at Shouldice Hospital is 1.15% (mainly wire use). The published 1-year recurrence rate in Europe is 2% \[1-3\]. Statistics: non-inferiority: delta for non-inferiority (defined equivalence range) = 1%. Total N = 1120 (0% dropout), with 20% dropout: N = 1400.) The same number of patients will be analyzed with regard to Shouldice repair due to a first relapse (time period of data extraction 2019-2021).

Since over 6000 hernias are operated annually, a consecutive data extraction of patients operated in 2021 will be performed.

Eligibility criteria: Inclusion Criteria:

* Adult patients of all sexes who have undergone inguinal hernia surgery in Shouldice technique.

Exclusion Criteria:

* Hernia repair using a mesh

Primary outcomes:
measure: Recurrence rate
timeFrame: 1 year
Secondary outcomes:
measure: Reoperation rate due to a recurrence
timeFrame: 1 year
Other outcomes:
Locations:
city: Thornhill
country: Canada
facility: Shouldice Hospital
state: Ontario
Study officials:
References:
Clinical trial NCT03448770: To Compare Efficacy and Safety of Lactulose Versus Polyethylene Glycol for Treatment of Overt Hepatic Encephalopathy in Cirrhotics.
Official title: To Compare Efficacy and Safety of Lactulose Versus Polyethylene Glycol for Treatment of Overt Hepatic Encephalopathy in Cirrhotics: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2018-02-28
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: All patients presenting to the emergency department of Institute of Liver and Biliary Sciences with known cirrhosis and hepatic encephalopathy with grade II will be included in the study. The patient will be randomized into one of the two arms of lactulose or polyethylene glycol. The patient on the lactulose arm will be administered 20 to 30 g of lactulose orally or by nasogastric tube (3 or more doses within 24 hours ) or if oral intake was not possible or inadequate. The Dose will be repeated to ensure 3-4 loose motions per day. The Polyethylene Glycol group will get 17 gm of PEG (Polyethylene Glycol) administered orally or via nasogastric tube. PEG (Polyethylene Glycol)will be administered in 3-4 doses in 24 hours to ensure 3-4 loose stools per day.


Eligibility criteria: Inclusion Criteria:

1. Documented cirrhosis with any underlying etiology
2. Hepatic encephalopathy of grade II and above
3. 18 to 65 years of age

Exclusion Criteria:

1. Acute change in mental status due to a diagnosis other than hepatic encephalopathy
2. Patients who have received lactulose as an anticoma measure before enrollment
3. Patient who have developed encephalopathy post bleed
4. Patients with gut paralysis
5. Patients with tense ascites
6. Patients with altered sensorium due to organic brain disease.
7. Patients with coexistent psychiatric illness that may hamper the proper assessment of hepatic encephalopathy
8. Hemodynamic instability obviating vasopressors for resuscitation
9. Acute liver failure defined as severe acute liver injury with encephalopathy and international normalized ratio (INR)≥1.5 in a patient without pre-existing liver disease
10. Refusal of consent

Primary outcomes:
measure: Complete reversal of hepatic encephalopathy in both groups.
timeFrame: 3 days
Secondary outcomes:
measure: Improvement in hepatic encephalopathy by two grades in both groups
timeFrame: 3 days
measure: Length of Intensive Care Unit stay in both groups
timeFrame: 28 days
measure: Adverse events in both groups
timeFrame: 3 days
measure: Presence of encephalopathy changes in Electroencephalography in both groups
timeFrame: 3 days
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of liver and Biliary Sciences
state: Delhi
Study officials:
References:
Clinical trial NCT07022470: Phase II Trial Comparison of 3 vs 4 Fractions (BRACHY-FIT).
Official title: Brachytherapy Fractionation Individualized by Treatment Feasibility in Cervical Cancer: Phase II Trial Comparison of 3 vs 4 Fractions (BRACHY-FIT).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Cervical Cancers
Keywords: high dose rate brachytherapy
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2025-06-15
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective non-randomized clinical trial to evaluate the feasibility of 3 fraction versus a standard 4 fraction high dose rate brachytherapy regimen in patients with locally advanced cervical cancer.


Eligibility criteria: Inclusion Criteria:

* Histologically documented malignancy of the cervix and planned to receive brachytherapy as part of definitive treatment.
* ECOG performance status of 0-2
* Age ≥ 18 years old.
* Ability to understand and the willingness to provide written informed consent.

Exclusion Criteria:

* Contraindication to receiving radiotherapy as determined by treating radiation oncologist.
* Contraindication to receiving MRI.
* Prior radiation to the pelvis \> 3 months ago
* Age \< 18 years old.
* Pregnant or breast-feeding

Primary outcomes:
measure: Proportion of Patients Receiving 3-Fraction Brachytherapy Regimen
timeFrame: Up to 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Elizabeth Kidd, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03392870: Evaluation of a Clinical Transitional Program in Autism
Official title: Evaluation of a Clinical Program Specialized in the Diagnosis, Follow-up and Treatment of Young Adults With a Autism Spectrum Disorder: "TAVA" (Spanish Acronym for "Support to Subjects With Autism in Their Transition to Adulthood")
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Autism Spectrum Disorder (ASD)
Keywords: Autism Spectrum Disorder (ASD)
Transition program
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2018-01-08
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 21
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Clinical trial without drug, randomized: Comparison of a specific and integrative clinical protocol for young adults with autism to usual treatment. It will include both low and high-functioning participants.


Eligibility criteria: Inclusion Criteria:

* ASD diagnosis
* Previous follow-up by child and adolescent psychiatry department at Corporació Sanitària Parc Taulí (CSPT)

Exclusion Criteria:

- Living in a disabled residential setting

Primary outcomes:
measure: Change in Quality of life.
timeFrame: Baseline, 24 months
Secondary outcomes:
measure: Change in: Asperger Symptoms.
timeFrame: Baseline, 24 months
measure: Change in: Depressive symptoms
timeFrame: Baseline, 24 months
measure: Change in: Anxiety Symptoms.
timeFrame: Baseline, 24 months
measure: Change in: Obsessive-compulsive symptoms.
timeFrame: Baseline, 24 months
measure: Change in: ASD symptoms evaluated by parents/caregiver.
timeFrame: Baseline, 24 months
measure: Change in: ASD symptoms.
timeFrame: Baseline, 24 months
measure: Change in: Social phobia symptoms.
timeFrame: Baseline, 24 months
measure: Change in: Evaluation of support needs.
timeFrame: Baseline, 24 months
measure: Change in: Caregiver's burden associated with the disorder.
timeFrame: Baseline, 24 months
measure: Change in: Evaluation of the level of autonomy, self-regulation, self-empowerment, self-knowledge.
timeFrame: Baseline, 24 months
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporacio Sanitaria Parc Tauli
state: Barcelona
Study officials:
affiliation: CORPORACIO SANITARIA PARC TAULI
name: ESTHER VIA, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03641599: Right Ventricular Function in Heart Failure
Official title: Assessment Right Ventricular Systolic Function in Heart Failure With Preserved, Reduced and Mid-range Ejection Fraction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Assessment of the RV Function in Patients With Heart Faliure
Keywords: RV systolic function
HFpEF
HFmrEF
HFrEF
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2018-08-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: HFpEF\>50%, HFrEF\<40% and HFmrEF \>40% and \<50%

Brief summary: Only a few studies evaluated the RV systolic function in the three categories of HF, regarding the importance of understanding changes in RV function on clinical presentation and outcome; it was essential to understand the prevalence and severity of RV dysfunction among the three groups and the degree of correlation between RV with LV systolic function.


Eligibility criteria: Inclusion Criteria:

-

Adult patients of both gender who have the followiong criteria :

(i) symptoms with or without signs of HF (ii) elevated natriuretic peptides (BNP ≥35pg/ mL or NT-proBNP≥125pg/mL) (iii) relevant structural heart disease: left ventricle hypertrophy (left ventricular mass index ≥115 g/m2 for males and ≥95 g/m2 for females) or left atrial enlargement (\>34 mL/m2) or diastolic dysfunction (E/e'≥13 and a mean e' septal and lateral wall \<9 cm/s) were included.

Then patients were classified according to EF into HFpEF\>50%, HFrEF\<40% and HFmrEF \>40% and \<50%

Exclusion Criteria:

Patients with chronic obstructive pulmonary disease history of pulmonary embolism patients with respiratory failure

Primary outcomes:
measure: assessment of the RV systolic dysfunction in patients with heart failure
timeFrame: 1.5 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Mostafa S. Assessment of right ventricular systolic function in heart failure with preserved, reduced and mid-range ejection fraction. Indian Heart J. 2019 Sep-Oct;71(5):406-411. doi: 10.1016/j.ihj.2019.11.252. Epub 2019 Nov 20.
Clinical trial NCT03612999: Data Acquisition to Model Glycemic Response
Official title: Data Acquisition to Model Glycemic Response to Food and Other Events Using Real-Time Continuous Glucose Monitoring (RT-CGM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Savvysherpa, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-02
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: To learn about individual glycemic response to physiological and psychological conditions across a diverse population, the investigators will collect sensor and lifestyle data directly from participants as they engage in daily activities. The investigators will collect real-time glucose data from a continuous glucose monitor (CGM) system; accelerometer, aggregated activity, and sleep data from a wrist-worn activity tracker; mood and experiential data; and food information. Non-sensor data will be collected using a paper log, or via a study app when available.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years old
* Be able to read, speak, and understand English
* Have a primary care provider

Exclusion Criteria:

* Not receive or require kidney dialysis
* Not be pregnant
* Not have type 1 diabetes
* Not have type 2 diabetes and be prescribed three or more daily injections of insulin

Primary outcomes:
measure: Glucose Level (mg./dl.)
timeFrame: 20 days per participant
Secondary outcomes:
measure: Activity level (steps per hour)
timeFrame: 20 days per participant
measure: Food Consumption (type and quantity)
timeFrame: 20 days per participant
measure: Activities of daily living (free form)
timeFrame: 20 days per participant
measure: Psychological state (free-form)
timeFrame: 20 days per participant
measure: Sensor wear time (wear / no-wear intervals)
timeFrame: 20 days per participant
measure: Transmitter life expectancy (number of minutes)
timeFrame: 20 days per participant
Other outcomes:
Locations:
city: Minnetonka
country: United States
facility: Savvysherpa, LLC
state: Minnesota
Study officials:
References:
Clinical trial NCT02873299: High-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex in PTSD
Official title: High-Frequency Repetitive Transcranial Magnetic Stimulation of the Right Dorsolateral Prefrontal Cortex in Post Traumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: PTSD, Post Traumatic Stress Disorder
Keywords: PTSD, Post Traumatic Stress Disorder
Lead sponsor: United States Naval Medical Center, San Diego
Sponsor class: FED
First posted: 2016-08-19
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare two slightly different methods of transcranial magnetic stimulation (TMS) to treat Post Traumatic Stress Disorder (PTSD)

Detailed description: This is a randomized single-blind pilot study investigating the efficacy of high-frequency repetitive transcranial magnetic stimulation (rTMS) applied to the right dorsolateral prefrontal cortex at either 10 Hz or 20 Hz as compared to a treatment as usual group for the treatment of Post Traumatic Stress Disorder (PTSD) symptoms.

Eligibility criteria: Inclusion Criteria:

* Willing and able to give informed consent
* Diagnosis of Post-Traumatic Stress Disorder as determined by the SCID
* CAPS score of at least 40
* Males or females between 18-65 years of age
* Willing to give up new psychotherapy or changes in psychiatric medications during the course of the TMS treatment.

Exclusion Criteria:

* Current primary Axis I disorder including Schizophrenia, Bipolar Disorder type I, Major Depressive Disorder
* Patients with HDRS score ≥ 18
* A metallic implant in cranium (except the mouth)
* Patients with severe or unstable medical conditions, which in the opinion of the investigator would interfere with their progress or safety
* ECT treatment within the last three months
* Patients with a history of epilepsy
* Patients with neurological disorder leading to increased intracranial pressure
* Participation in a new course of psychotherapy during the 24 days of the study
* A new psychiatric medication within 6 weeks of enrolling in the study
* Changes in psychiatric medication within 2 weeks of starting the study

Primary outcomes:
measure: Clinician Administered PTSD Scale , CAPS
timeFrame: day 10
Secondary outcomes:
measure: Posttraumatic Stress Disorder Checklist, PCL
timeFrame: week 24
Other outcomes:
Locations:
city: San Diego
country: United States
facility: NMCSD
state: California
Study officials:
affiliation: NMCSD
name: Marc A Capobianco, MD, DFAPA
role: PRINCIPAL_INVESTIGATOR
References: