louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03435055: Network-Level Effects of Nitrous Oxide in the Human Brain
Official title: Network-Level Effects of Nitrous Oxide in the Human Brain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 21
Sex: ALL
Minimum age (years): 21
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to understand how a commonly used drug, nitrous oxide, acts on the brain to reduce pain. Nitrous oxide is commonly used in anesthesiology but there is limited knowledge on how this drug affects functional networks in the brain.

Detailed description: The objective of this study is to identify the network transformations that account for the analgesic effects of nitrous oxide. Our hypothesis is that analgesic doses of nitrous oxide increase network efficiency and disrupt normal pain processingOur approach is to administer subanesthetic nitrous oxide during the acquisition of fMRI (functional magnetic resonance imaging) and EEG (electroencephalogram).

Eligibility criteria: Inclusion Criteria:

1. Body mass index \<30
2. Must be right-handed
3. Must be capable of giving written informed consent

Exclusion Criteria:

1. History of obstructive sleep apnea;
2. History of a difficult airway with a previous anesthetic
3. Gastroesophageal reflux;
4. Hypertension or other cardiovascular abnormalities;
5. Pulmonary hypertension;
6. History of recreational drug use;
7. History of chronic alcohol abuse
8. Having any chronic medical illness involving pain;
9. History of major depression;
10. History of psychosis or bipolar disorder;
11. History of methylenetetrahydrofolate reductase deficiency;
12. History of a known hypersensitivity to ketamine, midazolam, Zofran, labetalol or glycopyrrolate
13. History of seizures or other neurologic disorders;
14. Pregnant or nursing mothers;
15. Tattoos on the head or neck region - all other tattoos are subject to determination by investigators;
16. Contraindications to neuroimaging methods;
17. Any impairment, activity or situation that in the judgment of the Study Coordinator or Principal Investigators would prevent satisfactory completion of the study protocol.

Primary outcomes:
measure: Functional Connectivity During Nitrous Oxide
timeFrame: Baseline to 50 minutes
measure: Functional Connectivity Associated With Tonic Stimulus
timeFrame: Baseline to 50 minutes
Secondary outcomes:
measure: Tonic Stimulus Intensity During Nitrous Oxide
timeFrame: Baseline to 50 minutes
measure: Spectral Power of Sub-anesthetic Dose of Nitrous Oxide
timeFrame: Baseline to 50 minutes
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Michigan Medicine - University of Michigan
state: Michigan
Study officials:
affiliation: Associate Professor of Anesthesiology and Associate Professor of Internal Medicine
name: Richard Harris, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02878655: Evaluation of the Overall Quality of Life After the Neck Dissection Retro-spinal Sector (IIb), in Squamous Cell Carcinomas Clinical and Radiological N0 VADS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SCCHN
Keywords: N0 clinical and radiological
dissection IIb sector
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2016-08-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with SCCHN, N0 clinical and radiological, enjoying a dissection IIb sector

Brief summary: The nodal involvement in squamous cell carcinomas of the upper aerodigestive tract (VADS) is one of the main factors of poor prognosis, justifying the surgical management of neck dissection as a reference treatment.

Under the influence of the American Hayes Martin, it was considered until the 1960s that "over the intervention was, the greater the chance of recovery was". But has since been developed by the Argentine Osvaldo Suarez the concept of functional course, which consists of resection of lymph node tissue while retaining the main structures (muscles, nerves, vessels), as opposed to the recess radical which is reserved for the invasive metastasis.

In addition to these notions, our job is to evaluate the quality of life of patients with SCCHN, N0 clinical and radiological, enjoying a functional neck dissection including IIb sector to support the approach which would be to stop the systematic inclusion of this territory.


Eligibility criteria: Inclusion Criteria:

* Patient with SCCHN histologically proven N0 clinical and radiological
* Neoplastic Location: oral cavity, oropharynx, hypopharynx, larynx
* Patient candidate for a neck dissection fonctonnel
* Life expectancy\> 3 months
* Stable patient not exhibiting at the time of recurrence sign of examination or other scalable neoplasia
* Age over 18 ans
* Patient was informed of the study
* Patient fluent French

Exclusion Criteria:

* Patients with a history of malignancy, outside a basal cell cancer or cancer of the neck treated and cured
* Patient has at the time of examination of recurrence of signs or other scalable neoplasia
* Uncontrolled Infectious diseases
* Neoadjuvant radiotherapy
* Patient nursing or pregnant or lack of contraception during their reproductive
* Intercurrent pathology involving life-threatening
* Any medical or psychological condition associated that could compromise the patient's ability to participate in the study
* Inability to submit to medical follow-up study for geographical, social or psychic

Primary outcomes:
measure: Visual Annalogue Scale for Global Quality of Life
timeFrame: change over baseline and month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Caen
country: France
facility: Caen University Hospital
Study officials:
References:
Clinical trial NCT06300255: Evaluation of the H.O.O.V.E.S. Healing Intensives Program
Official title: Evaluation of the H.O.O.V.E.S. Healing Intensives Program
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anxiety
PTSD
Depression
Keywords: Horses
Anxiety
PTSD
Depression
Lead sponsor: VA Salt Lake City Health Care System
Sponsor class: FED
First posted: 2024-03-08
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Veterans enrolled in a H.O.O.V.E.S. healing intensives program and must have served in the military.

Brief summary: The aim of this study is to measure the impact of these H.O.O.V.E.S. healing intensives on Veteran participants using several psychological instruments. The investigators are planning to administer the demographic questionnaires and psychological instruments to Veteran participants before the healing intensives. Psychological instruments will be administered immediately pre-intervention, pre- and post-session for each session, post-intervention, 90, 120 and 360 days post-intervention. The primary aim is to assess for statistically significant changes pre- to post session and pre- to post-intervention.


Eligibility criteria: Inclusion Criteria:

* Veterans who have served in the military
* Must be enrolled in a H.O.O.V.E.S. Healing Intensives Program
* English speakers

Primary outcomes:
measure: Mean Difference in AAQII pre- to post-session and pre- to post-intervention
timeFrame: through study completion, an average of 5 years
measure: Mean Difference in PANAS pre- to post-session and pre- to post-intervention
timeFrame: through study completion, an average of 5 years
measure: Mean Difference in STAI pre- to post-session and pre- to post-intervention
timeFrame: through study completion, an average of 5 years
measure: Mean Difference in PCL pre- to post-session and pre- to post-intervention
timeFrame: through study completion, an average of 5 years
measure: Mean Difference in BDI pre- to post-session and pre- to post-intervention
timeFrame: through study completion, an average of 5 years
measure: Mean Difference in PTGI pre- to post-session and pre- to post-intervention
timeFrame: through study completion, an average of 5 years
measure: Mean Difference in B-SCS pre- to post-session and pre- to post-intervention
timeFrame: through study completion, an average of 5 years
Secondary outcomes:
measure: Mean Difference in AAQII pre- to post-session
timeFrame: through study completion, an average of 5 years
measure: Mean Difference in PANAS pre- to post-session
timeFrame: through study completion, an average of 5 years
measure: Mean Difference in STAI pre- to post-session
timeFrame: through study completion, an average of 5 years
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: George E. Wahlen Department of Veterans Affairs Medical Center
state: Utah
Study officials:
affiliation: VA Salt Lake City HCS
name: William Marchand, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03228355: Headache Inducing Effect of Cromakalim in Migraine Patients
Official title: The Effects of Levcromakalim on Cerebral Hemodynamic in Migraine Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache, Migraine
Keywords: Levcromakalim
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2017-07-24
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: Inclusion Criteria:

* Migraine patients of both sexes.
* 18-60 years.
* 50-90 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.

Primary outcomes:
measure: Cerebral hemodynamic
timeFrame: Before (-10 min) and after infusion (+2 hours) of levcromakalim compared with before and after infusion of saline
measure: Headache
timeFrame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
measure: Migraine attack
timeFrame: Before (-10 min) and after infusion (+12 hours) of levcromakalim compared with before and after infusion of saline
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Danish headache center
state: Glostrup
Study officials:
affiliation: DHC
name: Messoud Ashina, Professor
role: STUDY_DIRECTOR
References:
citation: Al-Karagholi MA, Hansen JM, Guo S, Olesen J, Ashina M. Opening of ATP-sensitive potassium channels causes migraine attacks: a new target for the treatment of migraine. Brain. 2019 Sep 1;142(9):2644-2654. doi: 10.1093/brain/awz199.
Clinical trial NCT02218255: Eeva™ Pregnancy Pilot Study (PPS)
Official title: Eeva™ Pregnancy Pilot Study (PPS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Keywords: In Vitro Fertilization
Lead sponsor: Progyny, Inc.
Sponsor class: INDUSTRY
First posted: 2014-08-18
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical investigation is to gather pilot data to evaluate the impact of using Eeva™, a time-lapse enabled embryo test, in combination with traditional morphology on clinical pregnancy rates.


Eligibility criteria: Inclusion Criteria:

* Women undergoing fresh in vitro fertilization treatment using their own eggs
* ≤ 40 years
* ≥ 4 diploid embryos (i.e. having 2 PNs)
* ≤ 3 Prior ART cycles (IVF, ICSI and related procedures)
* All 2PN embryos (for all 3 arms) must be imaged by Eeva
* Subject willing to comply with study protocol and procedures
* Subject willing to provide written informed consent

Exclusion Criteria:

* Preimplantation genetic diagnosis or preimplantation genetic screening
* Planned "freeze all" cycle (eggs or embryos)
* Asherman's Syndrome
* Donor egg
* Gestational carrier
* Presence of Hydrosalpinx on ultrasound
* Concurrent participation in an interventional clinical study

Primary outcomes:
measure: Clinical Pregnancy
timeFrame: 7-8 weeks gestation
Secondary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 8-12 week gestation
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
citation: Kaser DJ, Bormann CL, Missmer SA, Farland LV, Ginsburg ES, Racowsky C. A pilot randomized controlled trial of Day 3 single embryo transfer with adjunctive time-lapse selection versus Day 5 single embryo transfer with or without adjunctive time-lapse selection. Hum Reprod. 2017 Aug 1;32(8):1598-1603. doi: 10.1093/humrep/dex231.
Clinical trial NCT01712555: Autologous Fat Grafting With PRP (Platelet Rich Plasma) to Anophthalmic Sockets
Official title: Autologous Fat Grafting to Anophthalmic Sockets With PRP (Platelet Rich Plasma) Using a Closed Cannula Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orbital Atrophy
Keywords: Anophthalmic orbits
autologous fat
platelet rich plasma
orbital atrophy
anophthalmos
cannula
Lead sponsor: Fox, Donald Munro, M.D., P.C.
Sponsor class: INDIV
First posted: 2012-10-23
Enrollment: 5
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: After people lose an eye, for whatever reason, they often experience fat atrophy of the tissues in the orbit. This leads to a sunken appearance that is often not correctable by a cosmetic shell prosthesis. Current techniques to correct this deformity are inadequate/ invasive. Injection of various gels (Restylane, Radiesse) are temporary had have their own disadvantages. This study seeks to demonstrate an improvement in the retention of injected autologous fat by mixing in autologous PRP (platelet rich plasma).


Eligibility criteria: Inclusion Criteria: anophthalmos, orbital atrophy -

Exclusion Criteria:poor anesthesia risk, people outside a 100 mile radius of New York City

-

Primary outcomes:
measure: Improved retention of autologous fat injected into anophthalmic sockets
timeFrame: 1-5 yrs
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Eye and Ear Infirmary
state: New York
Study officials:
References:
Clinical trial NCT06556355: Anastomotic Leaks in Esophageal Squamous Cell Carcinoma Patients After Trimodal Therapy
Official title: Impact of Preoperative Radiation Dose to the Cervical Esophagus on Anastomotic Leak in Esophageal Squamous Cell Carcinoma Patients After Neoadjuvant Chemoradiation and McKeown Esophagectomy: A Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anastomotic Leak Esophagus
Keywords: esophageal cancer
anastomotic leak
neoadjuvant chemoradiation
radiation dose
esophagectomy
outcomes
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Chinese Institute of Food Science and Technology
First posted: 2024-08-16
Enrollment: 218
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients with locally advanced thoracic ESCC who underwent nCRT and surgery at our center between 1 January 2015 and 31 December 2020 were retrospectively identified and analyzed.

Brief summary: To investigate the clinical factors and preoperative treatment to the future anastomotic location of cervical esophagus that were correlated with anastomotic leaks in esophageal squamous cell carcinoma patients undergoing neoadjuvant chemoradiation and McKeown esophagectomy and to explore the prognosis of anastomotic leak.

Detailed description: The goal of this observational study is to investigate the clinical factors and preoperative treatment to the future anastomotic location of cervical esophagus that were correlated with anastomotic leaks in esophageal squamous cell carcinoma patients undergoing neoadjuvant chemoradiation and McKeown esophagectomy and to explore the postoperative complications, mortality, and long-term survival of different types of anastomotic leak.

Eligibility criteria: Inclusion Criteria:

* histologically confirmed ESCC;
* clinically staged as T3-4aN0M0 or T1-4aN+M0 by the eighth edition of the American Joint Committee on Cancer and treated with nCRT followed by McKeown esophagectomy24;
* aged 18-75 years;
* Eastern Cooperative Oncology Group performance status score ≤ 2.

Exclusion Criteria:

* cervical esophageal cancer;
* previously treated with chest radiotherapy, esophageal, or gastric surgery;
* insufficient clinical data.

Primary outcomes:
measure: anastomotic leak rate
timeFrame: Up to 1 month
Secondary outcomes:
measure: Overall survival
timeFrame: From date of pathological diagnosis until the date of death from any cause or censoring, assessed up to 36 months
Other outcomes:
measure: Pathologic complete response
timeFrame: Up to 1 month
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University Cancer Center, Guangzhou, China
name: Qiaoqiao Li
role: STUDY_CHAIR
affiliation: Sun Yat-sen University Cancer Center, Guangzhou, China
name: Chen Yang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04771455: Testing Intervention Strategies for Addressing Obesity and Binge Eating
Official title: Testing Intervention Strategies for Addressing Obesity and Binge Eating
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Binge Eating
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to conduct a randomized pilot trial of a mobile intervention that targets obesity and binge eating.


Eligibility criteria: Inclusion Criteria:

* Adults age 18 years or older
* Obesity (BMI ≥30)
* Recurrent binge eating (≥12 episodes in the past 3 months)
* Interested in losing weight and reducing binge eating
* Willing to use a mobile application
* Has a smartphone with Internet access and capacity for calls and text messaging
* Has a valid email address
* Has access to a scale
* Not pregnant
* English-speaking

Exclusion Criteria:

* Diagnosis for which the study/intervention is not clinically indicated
* Not currently receiving clinical services for weight management or binge eating

Primary outcomes:
measure: Weight
timeFrame: Measured at baseline, post-intervention (16-weeks)
measure: Binge Eating Episodes
timeFrame: Measured at baseline, post-intervention (16-weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
References:
Clinical trial NCT01639755: European New Texture Implant Clinical Experience With Shaped Breast Implants
Official title: European New Texture Implant Clinical Experience With Shaped Breast Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Augmentation
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-07-13
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to obtain clinical experience with the use of new texture, shaped breast implants in bilateral primary breast augmentation.


Eligibility criteria: Inclusion Criteria:

* Be willing to undergo bilateral breast augmentation with subglandular, submuscular, or biplanar placement of the breast implants by inframammary approach only
* Be a candidate for the device styles and sizes available in the study

Exclusion Criteria:

* Have tuberous breasts, congenital anomalies of the breast (e.g., Poland's Syndrome), or grade 3 ptosis
* Have undergone any previous breast surgery
* Have tissue covering determined inadequate or unsuitable by the surgeon

Primary outcomes:
measure: Investigator Overall Satisfaction With the Device Using a 5-Point Scale
timeFrame: 3 months
Secondary outcomes:
measure: Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire
timeFrame: 6 months
measure: Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue
timeFrame: 6 months
measure: Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale
timeFrame: Interim analysis: 12 months
measure: Percentage of Participants With Local Complications
timeFrame: Interim analysis: 12 months
Other outcomes:
Locations:
city: Göteburg
country: Sweden
facility: Klinik 34
city: Stockholm
country: Sweden
facility: Akademikliniken 10
Study officials:
affiliation: Allergan
name: Per Heden
role: STUDY_DIRECTOR
References:
Clinical trial NCT01279655: Motor Training and White Matter in Multiple Sclerosis (MS)
Official title: The Influence of a tDCS Combined Long-term Motor Training Program on Structural White Matter Changes in the Brain, Functionality and Psychological Outcome Measures in Multiple Sclerosis.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: KU Leuven
name: Provinciale Hogeschool Limburg
First posted: 2011-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the current study the researchers will firstly investigate whether a bimanual coordination training protocol (20 min/day, for 8 consecutive weeks) correlates with changes in white matter architecture and improved upper-limb functionality in patients with multiple sclerosis. Secondly, the researchers predict that motor learning is more efficient when it is combined with anodal transcranial direct current (tDCS) stimulation on the left primary motor cortex.


Eligibility criteria: Inclusion Criteria:

* Expanded Disability Status Scale (EDSS) scores between 2 and 6.5
* Stable MS (no relapse during the last 3 months before study onset)
* age: between 18 and 68 years

Exclusion Criteria:

* Patients with other pathologies associated with peripheral and/or central sensory dysfunction or under psychotropic or antiepileptic medication.
* Standard TMS/tDCS and MRI exclusion criteria (safety questionnaires)

Primary outcomes:
measure: Change in White Matter
timeFrame: Baseline, immediately after and 3 weeks after the intervention
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: Baseline, immediately after and 3 weeks after the intervention
measure: Blood sample
timeFrame: After the end of the study
Other outcomes:
Locations:
city: Diepenbeek
country: Belgium
facility: Hasselt University (BIOMED)
state: Limburg
Study officials:
affiliation: Hasselt University
name: Raf Meesen, Phd
role: PRINCIPAL_INVESTIGATOR
References: