louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00186784: Transcranial Magnetic Treatment (TMS) in Unipolar Depression
Official title: Repetitive Transcranial Magnetic Stimulation (rTMS) in Unipolar Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Unipolar Depression
Keywords: Repetitive Transcranial Magnetic Stimulation
TMS
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
Collaborators: name: Queen's University, Kingston, Ontario
First posted: 2005-09-16
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Repetitive Transcranial Magnetic Stimulation (rTMS) can improve mood and decrease sadness in patients with depression.

In this study, the investigators seek to increase their understanding about how rTMS improves depression, and to determine which form of rTMS is most effective for depression, when used in combination with antidepressant medication.

Detailed description: Patients will be assigned for 4 treatment arms, receiving either left high frequency plus right low frequency, or left high frequency plus right sham, or left sham, plus right low frequency, or left sham plus right sham treatment. All subjects will receive treatments for 10 days and will be followed for another 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Major Depression
* No physical health problems

Exclusion Criteria:

* History of Epilepsy
* Metal in the head/neck or skull
* Pacemaker
* Pregnancy

Primary outcomes:
measure: Hamilton Depression Rating Scale
timeFrame: Pre TMS and post TMS
measure: Beck Depression Rating Scale
timeFrame: pre TMS and post TMS
Secondary outcomes:
measure: Quantitive Electroencephalographic(QEEG)activity and measures of regional cerebral blood flow
timeFrame: pre TMS and post TMS as well as post phase II, second set of TMS
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St.Joseph's Healthcare, rTMS Laboratory, Mood Disorders Program, 100 West Fifth Street
state: Ontario
Study officials:
affiliation: McMaster University
name: Gary Hasey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jacquot F, Khoury S, Labrum B, Delanoe K, Pidoux L, Barbier J, Delay L, Bayle A, Aissouni Y, Barriere DA, Kultima K, Freyhult E, Hugo A, Kosek E, Ahmed AS, Jurczak A, Lingueglia E, Svensson CI, Breuil V, Ferreira T, Marchand F, Deval E. Lysophosphatidylcholine 16:0 mediates chronic joint pain associated to rheumatic diseases through acid-sensing ion channel 3. Pain. 2022 Oct 1;163(10):1999-2013. doi: 10.1097/j.pain.0000000000002596. Epub 2022 Jan 27.
Clinical trial NCT02391584: XprESS Eustachian Tube Dilation Study
Official title: XprESS Eustachian Tube Dilation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eustachian Tube Dysfunction
Lead sponsor: Entellus Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study to assess the safety and efficacy of the XprESS device for transnasal Eustachian tube dilation.

Detailed description: Prospective, multicenter, randomized controlled trial comparing balloon dilation of the Eustachian tube to continued medical management for treatment of persistent Eustachian tube dysfunction.

Eligibility criteria: Inclusion Criteria:

* ≥18 years old
* Have been diagnosed with symptoms of chronic Eustachian tube dysfunction for no less than 12 months prior to enrollment
* Have an overall ETDQ-7 score ≥3.0
* Have record of failed medical management for Eustachian tube dysfunction

Exclusion Criteria:

* Require concomitant procedures at the time of the study enrollment or procedure
* Have patulous Eustachian tube
* Have ear tubes in place or perforation of the tympanic membrane
* Have evidence of internal carotid artery dehiscence
* Be pregnant at the time of enrollment
* Be currently participating in other drug or device studies

Primary outcomes:
measure: Change From Baseline in Mean Overall ETDQ-7 Scores
timeFrame: 6 weeks post procedure (treatment arm) or randomization (control arm)
measure: Complication Rate
timeFrame: Through 6 months post-procedure
Secondary outcomes:
measure: Technical Success Rate
timeFrame: Immediately after procedure
measure: Revision Rate
timeFrame: 12 months
measure: Mean Change in Overall ETDQ-7 Score
timeFrame: 12 months postdilation
measure: Mean Change in Overall ETDQ-7 Score
timeFrame: 6 months postdilation
measure: Mean Change in Overall ETDQ-7 Score
timeFrame: 3 months postdilation
measure: Mean Change in Overall ETDQ-7 Score
timeFrame: 6 weeks postdilation
Other outcomes:
Locations:
city: Denver
country: United States
facility: Colorado Sinus Institute
state: Colorado
city: North Platte
country: United States
facility: Ear Nose Throat and Sinus Clinic
state: Nebraska
city: Sayre
country: United States
facility: Donald Guthrie Foundation
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Austin
country: United States
facility: Austin Ear Clinic
state: Texas
Study officials:
References:
citation: Meyer TA, O'Malley EM, Schlosser RJ, Soler ZM, Cai J, Hoy MJ, Slater PW, Cutler JL, Simpson RJ, Clark MJ, Rizk HG, McRackan TR, D'Esposito CF, Nguyen SA. A Randomized Controlled Trial of Balloon Dilation as a Treatment for Persistent Eustachian Tube Dysfunction With 1-Year Follow-Up. Otol Neurotol. 2018 Aug;39(7):894-902. doi: 10.1097/MAO.0000000000001853.
Clinical trial NCT05866484: Testicular Sperm Aspiration (TESA) vs. Microfluidic Sperm Separation (MSS)
Official title: Testicular Sperm Aspiration (TESA) vs. Microfluidic Sperm Separation (MSS) in Couples With High Sperm DNA Fragmentation Undergoing ICSI: Which Approach is Better
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility, Male
Azoospermia
Reproductive Disorder
Lead sponsor: Clinique Ovo
Sponsor class: INDUSTRY
First posted: 2023-05-19
Enrollment: 280
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This retrospective study will compare and investigate ICSI outcomes in couples with high sperm DNA fragmentation using either testicular sperm (TESA) or microfluidic sperm separation device (Zymot)

Brief summary: Normal embryonic development relies on the correct transmission of genetic information, and sperm DNA plays a crucial part in this process. Causes of poor sperm DNA integrity include unhealthy lifestyles such as smoking and exposure to gonadotoxins, as well as, obesity, varicoceles, infections, advanced paternal age and systemic disorders. An increase in DNA fragmentation in sperm has been linked to lower fertilisation rate, poorer quality embryos, lower pregnancy rate, and high miscarriages rate.

The best way for sperm selection and processing in assisted reproductive technologies (ART) should be noninvasive and cost-effective. It should also make it possible to identify high-quality spermatozoa and produce more favorable results in terms of pregnancy and live birth rates.7 Meanwhile, the microfluidic sperm separation technology is a less expensive and less invasive alternative. This method allows for the selection of motile sperm that have a normal morphology, low levels of reactive oxygen species (ROS), and low DFI


Eligibility criteria: Inclusion Criteria:

* Men with high DNA fragmentation (\>20%) undergoing TESA-ICSI or Zymot-ICSI

Exclusion Criteria:

* Spouse with advanced maternal age (\> 40 years)
* Egg donation cycle

Primary outcomes:
measure: Clinical Pregnancy Rate
timeFrame: approximately 8 weeks
Secondary outcomes:
measure: Number of utilizable blastocysts obtained
timeFrame: Approximately 20 days
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Clinique Ovo
state: Quebec
Study officials:
affiliation: Clinique Ovo
name: Armand Zini, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01320384: Clinical Effect of the Association of Noninvasive Ventilation and High Flow Nasal Oxygen Therapy in Resuscitation of Patients With Acute Lung Injury (FLORALI Study)
Official title: Clinical Effect of the Association of Noninvasive Ventilation and High Flow Nasal Oxygen Therapy in Resuscitation of Patients With Acute Lung Injury. A Randomised Study (FLORALI Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Acute Lung Injury
Acute Respiratory Failure
Keywords: ALI
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2011-03-22
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare, in patients with acute respiratory failure/acute lung injury the efficacy of three different methods of oxygenation to prevent endotracheal intubation :

1. conventional oxygen therapy (O2 conventional)
2. high flow nasal oxygen therapy (O2-HFN)
3. association of high flow nasal oxygen therapy with non invasive positive pressure ventilation (O2-HFN/NPPV).


Eligibility criteria: Inclusion Criteria:

* Hypoxemic and no hypercapnic acute respiratory failure :
* severe dyspnea at rest with a respiratory rate \>25 breaths/min
* PaO2/FiO2 \<300
* PaCO2 \<45 mmHg,

Exclusion Criteria:

* age \<18 years
* NPPV contraindications
* past history of respiratory chronic disease (COPD, cystic fibrosis...)
* cardiac pulmonary edema
* Pre-defined intubation
* other than respiratory organ failure : systolic pressure \<90 mmHg,current treatment with epinephrine or norepinephrine, decreased level of consciousness ( Glasgow score ≤ 12)
* profound aplasia (white cells count \<1000/mm 3)

Primary outcomes:
measure: To compare the number of patients in each group who require endotracheal intubation with mechanical ventilation
timeFrame: at day 28
Secondary outcomes:
measure: mechanical ventilation-free to day 28
timeFrame: 28 days
measure: ICU morbidity
timeFrame: at day 28
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Poitiers University Hospital
Study officials:
References:
citation: Frat JP, Thille AW, Mercat A, Girault C, Ragot S, Perbet S, Prat G, Boulain T, Morawiec E, Cottereau A, Devaquet J, Nseir S, Razazi K, Mira JP, Argaud L, Chakarian JC, Ricard JD, Wittebole X, Chevalier S, Herbland A, Fartoukh M, Constantin JM, Tonnelier JM, Pierrot M, Mathonnet A, Beduneau G, Deletage-Metreau C, Richard JC, Brochard L, Robert R; FLORALI Study Group; REVA Network. High-flow oxygen through nasal cannula in acute hypoxemic respiratory failure. N Engl J Med. 2015 Jun 4;372(23):2185-96. doi: 10.1056/NEJMoa1503326. Epub 2015 May 17.
Clinical trial NCT06576284: A 36-month Analysis of the Clinical Performance of Individualized CAD/CAM-produced Dental Implants: a Cohort Study
Official title: A 36-month Analysis of the Clinical Performance of Individualized CAD/CAM-produced Dental Implants: a Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tooth Loss
Dental Implant
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals who received a personalized dental implant using the iDENTICAL Dental Implant System

Brief summary: The goal of this prospective cohort study is to evaluate the clinical performance of a new generation of customized CAD/CAM pre-fabricated root-analog dental implants over a 36-month period. The main questions it aims to answer are:

1. Are these novel implants safe, effective, and clinically viable for 36 months?
2. Do these drilling-free implants result in better post-operative outcomes compared to traditional implant techniques? Twelve patients receiving these customized implants immediately after tooth extraction will undergo clinical and radiographic examinations at 12, 24, and 36 months after prosthesis installation. The study will assess peri-implant tissue health, post-operative comfort, bone preservation, tissue integration, and implant survival rates.


Eligibility criteria: Inclusion Criteria:

* Received a personalized dental implant using the iDENTICAL Dental Implant System during the previous interventional phase;
* Completed the 12-month follow-up period after implant placement in the previous interventional phase;
* Available for follow-up evaluations during the 36 months of the observational study.

Exclusion Criteria:

* Occurrence of serious complications (implant loss, infection, etc.) during the previous interventional phase;
* Development of uncontrolled medical conditions during the follow-up period;
* Inability to attend scheduled follow-up visits;
* Refusal to participate in the observational study.

Primary outcomes:
measure: Radiographic success
timeFrame: 12 months, 24 months and 36 months
Secondary outcomes:
measure: Linear horizontal changes of peri-implant soft tissues
timeFrame: 12 months, 24 months and 36 months
measure: Prosthetic Level outomes
timeFrame: 12 months, 24 months and 36 months
measure: Peri-implant clinical parameters
timeFrame: 12 months, 24 months and 36 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: School of Dentistry - University of São Paulo
Study officials:
affiliation: University of Sao Paulo
name: Giuseppe A Romito, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04280484: Acute Intermittent Hypoxia in Persons With Multiple Sclerosis
Official title: Evaluating the Use of Acute Intermittent Hypoxia to Improve Symptoms in Persons With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis, Relapsing-Remitting
Lead sponsor: Shirley Ryan AbilityLab
Sponsor class: OTHER
Collaborators: name: Edward Hines Jr. VA Hospital
First posted: 2020-02-21
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The overall objective of this project is to investigate the effectiveness of Acute Intermittent Hypoxia (AIH), to improve muscle strength and activity level in individuals with relapsing-remitting MS.


Eligibility criteria: Inclusion Criteria:

* Have relapsing-remitting MS
* Volitional ankle plantar flexion strength in at least one leg
* Are relapse free for 30 days
* Patient-Determined Disease Steps scale score between 3 and 5 (3=gait disability to 5=late cane, need cane to walk 25 feet)

Exclusion Criteria:

* Currently taking antispasticity medications,
* Have cardiovascular or respiratory/pulmonary disorders, metabolic dysfunction, or prior diagnoses of obstructive sleep apnea
* Pregnant or nursing women (safety for developing fetus or infant is unknown)
* Cognitive concerns (must be able to consent to study, follow steps)

Primary outcomes:
measure: Voluntary Ankle Strength
timeFrame: 60 minutes post-intervention
Secondary outcomes:
measure: Electromyogram activity
timeFrame: 60 minutes post-intervention
measure: Symbol Digit Modalities Test
timeFrame: 60 minutes post-intervention
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Shirley Ryan AbilityLab
state: Illinois
Study officials:
References:
Clinical trial NCT06530784: Cryoablation Combined With PD-1 Antibody and Bevacizumab for Hepatocellular Carcinoma
Official title: Cryoablation Combined With PD-1 Antibody and Bevacizumab for Hepatocellular Carcinoma After Progression of PD-1/L1 Antibody Treatment: a Pilot Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Carcinoma, Hepatocellular
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cryoablation combined with PD-1 antibody and bevacizumab
Primary purpose: TREATMENT

Brief summary: To explore the safety and efficacy of cryoablation combined with PD-1 antibody and bevacizumab for patients with hepatocellular carcinoma resistance to PD-1/L1 antibody.


Eligibility criteria: Inclusion Criteria:

1. Age between 18 and 80 years old, and expected survival is longer than 3 months
2. Clinically or pathologically diagnosed as primary hepatocellular carcinoma
3. Disease progression assessed according to mRECIST criteria after PD-1/L1 antibody treatment
4. Child-Pugh score of liver function A/B (\< 7)
5. At least one lesion is suitable for mRECIST assessment
6. Strength score (ECOG): 0-1
7. The patient and/or family members agree to join the clinical trial and sign the informed consent form

Exclusion Criteria:

1. Patients whose tumor lesions are not suitable for ablation as assessed by the surgeon
2. Tumor burden greater than ≥70%, or tumor is not suitable for mRECIST standard evaluation
3. Patients with chronic viral hepatitis (hepatitis B, hepatitis C) have a viral load greater than 10\^4 before receiving treatment or do not continue to take antiviral drugs regularly
4. Pregnant patients
5. Combined with other malignant tumors, or have a history of other malignant tumors within 3 years
6. Active autoimmune disease, confirmed immunodeficiency, history of systemic steroid medication
7. Severe renal dysfunction: creatinine (Cr) \> 2 mg/dL or creatinine clearance (CCr) \<30 mL/min, severe heart, lung, brain and other important organ diseases
8. History of gastrointestinal bleeding within 3 months
9. Unable to cooperate with ablation surgery
10. Severe gastroesophageal varices

Primary outcomes:
measure: Progression-free survival
timeFrame: Up to 2 years
Secondary outcomes:
measure: Time to progress
timeFrame: Up to 2 years
measure: Objective Response Rate
timeFrame: Up to 2 years
measure: Overall survival
timeFrame: Up to 2 years
measure: Adverse events
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Jian Zhou
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01421784: Using Rapid Cine-MRI for Monitoring Moving and Deforming Tumors
Official title: Investigating the Feasibility of Using Rapid Cine-MRI for Monitoring Moving and Deforming Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lung Cancer
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2011-08-23
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In this study, the researchers investigate the feasibility of using rapid cine MR imaging to provide both offline and online soft-tissue-based image guidance. Such images will provide a significantly more complete picture of the spatial and temporal changes in thoracic anatomy. This more complete information will lay the groundwork for better radiotherapy planning and dose delivery in the presence of respiratory motion.

Detailed description: Rapid MRI scans from Stage I-IV non-small-cell lung cancer (NSCLC) patients will be acquired. MR acquisition will be performed without extrinsically administered contrast, using a balanced turbo field echo (TFE) sequence and commercially available coils.

Eligibility criteria: Inclusion Criteria:

* AJCC Stage I, II, III or IV non-small-cell lung cancer to be treated using radiotherapy will be eligible for this study.
* Any types and amounts of prior therapy will be allowed for this study.
* Subjects must be greater than or equal to 18 years of age. There are no gender or ethnic restrictions.
* Ability to understand and the willingness to sign a written informed consent document.
* Able to tolerate supine position
* ECOG performance status of 3 or less

Exclusion Criteria:

* MRI-incompatible metallic implants, embedded metallic objects, implanted biomedical devices e.g., cardiac pacemakers
* Women who are pregnant or trying to get pregnant
* Pain in supine position

Primary outcomes:
measure: To measure time series of MRI imaging by the b-SSFP sequence.
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern Medical Center
name: Amit Sawant, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04864002: TRIGGERING AND PROTECTIVE FACTORS OF BURNOUT IN MEDICAL RESIDENT
Official title: TRIGGERING AND PROTECTIVE FACTORS OF BURNOUT IN MEDICAL RESIDENT PHYSICIANS IN A LOWER-MIDDLE-INCOME COUNTRY: A CROSS-SECTIONAL STUDY
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burnout, Professional
Keywords: Burnout
Residents
Medicine
Pakistan
Lead sponsor: Aga Khan University
Sponsor class: OTHER
First posted: 2021-04-28
Enrollment: 71
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Internal Medicine residents working at two institutes

Brief summary: Residents and interns are prone to emotional and physical exhaustion, also known as burnout. Burnout has not been studied much in physicians working in lower-middle income countries. We conducted this cross-sectional study at two institutes to determine the burden of burnout among internal medicine residents and to identify triggering and protective factors associated with burnout. An abbreviated version of the Maslach Burnout scale was used to measure burnout, and protective and triggering factors were recorded according to known factors.


Eligibility criteria: Inclusion Criteria:

- All residents of the internal medicine program at both institutes

Exclusion Criteria:

* Residents who were part of a flexible training program, working in shifts and those who had done less than six months of training were excluded

Primary outcomes:
measure: Burnout
timeFrame: 1 year
Secondary outcomes:
measure: Triggering factors
timeFrame: 1 year
measure: Protective factors
timeFrame: 1 year
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Aga Khan University Hospital
state: Sindh
Study officials:
References: