louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02058732: Therapeutic Imaging Biomarkers for Amyotrophic Lateral Sclerosis
Official title: Therapeutic Imaging Biomarkers for Amyotrophic Lateral Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2014-02-10
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Study the cervical spinal cord and brain over time to assess changes and differences in subjects with amyotrophic lateral sclerosis.

Detailed description: Investigators will study cervical spinal cord chemical concentrations and cervical spinal cord and brain microstructure in amyotrophic lateral sclerosis(ALS) patients who have had a stem cell transplant compared to ALS patients who have not had a stem cell transplant. Investigators intend to determine cervical spinal cord chemical concentrations and cervical spinal cord and brain microstructure in amyotrophic lateral sclerosis(ALS) patients who have had a stem cell transplant and compare these to corresponding measures in amyotrophic lateral sclerosis(ALS) patients who have not had a stem cell transplant.

Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. Subjects with amyotrophic lateral sclerosis -

Exclusion Criteria:

1. Do not have opportunistic central nervous system infection
2. Do not have a history of head injury
3. Do not have cerebrovascular disease
4. Do not have a contraindication for MRI(e.g. cardiac pacemaker, ferromagnetic or metallic implants).
5. Must not be pregnant -

Primary outcomes:
measure: Changes in spinal cord metabolites in treated ALS subjects and nontreated ALS subjects.
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Hospital
state: Michigan
Study officials:
affiliation: University of Michigan Hospital
name: Bradley Foerster, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01397032: Attention Bias Modification Treatment for Children With Social Anxiety
Official title: Attention Bias Modification Treatment for Children With Social Anxiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Social Phobia
Keywords: attention bias modification treatment
cognitive bias modification
attention training
social anxiety
Lead sponsor: Tel Aviv University
Sponsor class: OTHER
First posted: 2011-07-19
Enrollment: 67
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Children with social anxiety will be randomly assigned to either Attention Bias Modification Treatment (ABMT) designed to direct attention away from threat or a placebo control condition not designed to change attention patterns. Outcome measures will be depression and social anxiety symptoms as measured by gold standard questionnaires as well as diagnosis of social phobia disorder and symptom counts derived from structured clinical interviews with children and their parents.

We expect to see significant reduction in social anxiety symptoms in the Attention Bias Modification Treatment (ABMT) group relative to the placebo control group.


Eligibility criteria: Inclusion Criteria:

* children suffering from social anxiety

Exclusion Criteria:

* Pharmacological or Psychological treatment

Primary outcomes:
measure: Anxiety Disorders Interview Schedule for DSM-IV (ADIS)
timeFrame: expected average time frame of 6 weeks. Participants will be assessed before and after the administriation of the training/control protocols.
Secondary outcomes:
measure: Social Phobia and Anxiety Inventory for Children (SPAI-C) and for Parents (SPAI-c-p)
timeFrame: expected average time frame of 6 weeks. Participants will be assessed before and after the administriation of the training/control protocols.
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Tel-Aviv University
Study officials:
affiliation: Tel Aviv University
name: Yair Bar-Haim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hakamata Y, Lissek S, Bar-Haim Y, Britton JC, Fox NA, Leibenluft E, Ernst M, Pine DS. Attention bias modification treatment: a meta-analysis toward the establishment of novel treatment for anxiety. Biol Psychiatry. 2010 Dec 1;68(11):982-90. doi: 10.1016/j.biopsych.2010.07.021.
citation: Pergamin-Hight L, Pine DS, Fox NA, Bar-Haim Y. Attention bias modification for youth with social anxiety disorder. J Child Psychol Psychiatry. 2016 Nov;57(11):1317-1325. doi: 10.1111/jcpp.12599. Epub 2016 Jul 20.
Clinical trial NCT02411032: Fresh Start Experiment
Official title: Fresh Start Experiment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Hypertension
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2015-04-08
Enrollment: 13323
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The investigators are proposing an experiment to help Humana investigate when to launch programs or send messages that are designed to improve customers' engagement. The investigators' past research has shown that certain life events and calendar events (e.g., a job change, a birthday, a holiday, Monday) feel like a "fresh start" to people and have the potential to motivate them to begin pursuing their health goals (e.g., exercising, starting a diet, quitting smoking).

Detailed description: The investigators are proposing an experiment to help Humana investigate when to launch programs or send messages that are designed to improve customers' engagement. The investigators' past research has shown that certain life events and calendar events (e.g., a job change, a birthday, a holiday, Monday) feel like a "fresh start" to people and have the potential to motivate them to begin pursuing their health goals (e.g., exercising, starting a diet, quitting smoking). In this experiment, the investigators will test (a) whether Humana can increase the effectiveness of its messages by sending them to customers around fresh starts moments and (b) whether highlighting a recent fresh start event in Humana's messages can further increase customer engagement.

Eligibility criteria: Inclusion Criteria:

* customers of our insurance company partner

Exclusion Criteria:

* none

Primary outcomes:
measure: Medication refills
timeFrame: 6 months
Secondary outcomes:
measure: Hemoglobin A1C
timeFrame: 6 months
measure: LDL cholesterol
timeFrame: 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Katherine Milkman, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06803732: Postoperative Pain of Robotic, Endoscopic and Open Lateral Neck Dissection
Official title: Postoperative Pain of Robotic, Endoscopic and Open Lateral Neck Dissection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pain, Postoperative
Thyroid Diseases
Surgery
Keywords: Lateral neck dissection
Robotic thyroid surgery
Minimally invasive surgery
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2025-01-31
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with FNA proven differentiated thyroid cancer and metastatic lateral lymph nodes, underwent lateral neck dissection via robotic, endoscopic or open approach. Patients were well informed about the potential benefits and risks of robotic, endoscopic and open approach. Patient consented for us to use perioperative data.

Brief summary: Postoperative pain is a good indicator to confirm the advantages of the surgical methods in the era of minimally invasive surgery. Lateral neck dissection requires extensive dissection which may leads to postoperative numbness and pain. Robotic thyroid surgery has the advantage of precise and careful dissection and avoid the L-shape incision in the open approach. The study aims to explore the pain intensity and severity of lateral neck dissection on operation day, postoperative month 1 and postoperative month 3 among the robotic, endoscopic and open approach.


Eligibility criteria: Inclusion Criteria:

* Patients underwent lateral neck dissection via robotic, endoscopic or open approach
* Clinical diagnosis of differentiated thyroid cancer
* Clinical diagnosis of metastatic lateral lymph nodes

Exclusion Criteria:

* Participants with distant metastasis
* Participants with history of neck surgery or radiation
* Participants with vocal fold fixation by preoperative fibrolaryngoscope

Primary outcomes:
measure: degree of pain
timeFrame: approximately 4 hours after surgery, on postoperative day 1, postoperative month 1 and postoperative month 3
measure: Number of participants with recurrent laryngeal nerve injury
timeFrame: through study completion, an average of 1 year
measure: Number of participants with hypoparathyroidism
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 6th People's Hospital
name: Ling Zhan, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04505332: Back Pain and Arthroplasty in Orthopedists
Official title: Investigation of the Relationship Between Back Pain and Arthroplasty in Orthopedists
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Chronic
Back Pain
Lead sponsor: Uludag University
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The relationship between arthroplasty and low back pain in orthopedists will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Those who have received specialization of orthopaedics and work as a orthopaedics surgery.
* Those who want to participate in the study

Exclusion Criteria:

* Patients with discomfort and operation due to the low back pain
* Physicians in other branches

Primary outcomes:
measure: back pain in orthopedists
timeFrame: 2 month
Secondary outcomes:
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Ali Erkan YENIGUL
Study officials:
References:
Clinical trial NCT01222832: Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge
Official title: Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge After Functional Endoscopic Sinus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Paranasal Sinus Disease
Lead sponsor: Steward St. Elizabeth's Medical Center of Boston, Inc.
Sponsor class: OTHER
First posted: 2010-10-18
Enrollment: 226
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will evaluate the efficacy of a nasopore sponge dressing soaked in Bacitracin VS a sponge soaked in Saline / and the administration of oral antibiotics.

Detailed description: Same as above

Eligibility criteria: Inclusion Criteria:

* Patient having primary or revision sinus surgery. Aged 18 years or older.Patients must have middle meatus easily identified. The type of surgery will not be influenced by the participation in this study.

Exclusion Criteria:

* Age less then 18
* Known sensitivity to Bacitracin
* Pregnancy

Primary outcomes:
measure: Rate of Infection
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Brighton
country: United States
facility: St. Elizabeth's Medical Center
state: Massachusetts
Study officials:
affiliation: Steward St. Elizabeth's Medical Center of Boston, Inc.
name: Peter Catalano, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03191032: Early Sensory Re-education of the Hand With a Sensor Glove Model
Official title: Cortical and Functional Responses to an Early Protocol of Sensory Re-education of the Hand Using Audio-tactile Interaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Nerve Injuries
Keywords: Peripheral nerves/lesions; hands; rehabilitation; fMRI
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Fundação de Apoio ao Ensino, Pesquisa e Assistência do Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
First posted: 2017-06-19
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The implementation of early sensory re-education (SR) techniques, aimed to preserve the cortical hand area, such as the use of audio-tactile interaction, becomes an important strategy to obtain also a better sensory function. The aim of this study was to investigate sensory function outcomes (threshold monofilaments, two-point discrimination test, STI and DASH) and cortical responses (fMRI) in patients submitted to an early protocol of SR of the hand with a sensor glove model. After surgical repair of median and/or ulnar nerves, 17 participants were divided into two groups: the training group, trained on the protocol with the sensor glove model, and the control group, untrained. After six-month follow-up, no difference was observed between groups, related to sensory function, especially tactile gnosis. Despite this, the early training with this sensor glove model seems to provide some type of cortical audio-tactile interaction, contributing to previous studies that focus in early SR of the hand using the integration of different sensory modalities.


Eligibility criteria: Inclusion Criteria:

- Injury of the ulnar and/or median nerves at the wrist or distal forearm level surgically repaired

Exclusion Criteria:

* Neurological diseases
* Systemic diseases, which affected either directly or indirectly the central or peripheral nervous system
* Extensive traumas in the upper limbs

Primary outcomes:
measure: Sensory Threshold - Mann Whitney non-parametric test
timeFrame: First, Third and Sixth month post-operative
measure: Tactil Gnosis - Mann Whitney non-parametric test
timeFrame: First, Third and Sixth month post-operative
measure: Self-report function - Mann Whitney non-parametric test
timeFrame: First, Third and Sixth month post-operative
measure: Cortical responses - fMRI data analysed by Granger Causality Map
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paolo
name: Raquel M Sugano, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00880932: Warfarin and Non-Steroidal Anti-Inflammatory Drugs (NSAID) Customized Alert
Official title: The Effect of Customized Alerts Versus Generic Alerts for the Prescription of Warfarin and NSAID
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Warfarin and NSAID
Keywords: warfarin
NSAID
The condition is the concomitant prescription of
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
First posted: 2009-04-14
Enrollment: 1865
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The hypothesis is that a newly formatted electronic alert that requires the prescriber to pause and enter a specific "reason for override" on this alert, will cause prescribers in the intervention group to be significantly less likely to prescribe the combination of warfarin and NSAID than prescribers in the control group.


Eligibility criteria: Inclusion Criteria:

* All resident physicians (RP) and nurse practitioners (NP) involved in inpatient care at two hospitals of the University of Pennsylvania

Exclusion Criteria:

* None

Primary outcomes:
measure: Decreased rate of prescription of the combination of warfarin and NSAID
timeFrame: 17 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phila
country: United States
facility: Hospital of the University of Pennsylvania and Penn Presbyterian Medical Center
state: Pennsylvania
Study officials:
References:
Clinical trial NCT00455832: Influence of Ribavirin and Interferon on Semen Quality, IRIS Study
Official title: Influence of Ribavirin and Interferon on Semen Quality, IRIS Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sperm Motility (Focus of Study)
Keywords: sperm chromatin structure integrity
sperm concentration
sperm motility
sperm morphology
peginterferon
ribavirin
hepatitis C
Lead sponsor: Foundation for Liver Research
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
First posted: 2007-04-04
Enrollment: 23
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The aim of this study is to study the effect of peginterferon alpha and ribavirin on spermatozoa.

Detailed description: During and six months after treatment with peginterferon alpha and ribavirin strict use of birth control is recommended (the producers advice two reliable forms) for both men and women because ribavirin has teratogenic and/or embryo-lethal effects in animal studies.

In cases of pregnancies during paternal exposure to peginterferon alpha and ribavirin elective termination of the pregnancy is usually recommended. However three cases of births after paternal exposure are reported with no birth defects. Cases of abnormalities after paternal exposure to ribavirin are lacking.

Also studies on the influence of ribavirin on sperm in human are lacking.

The aim of this study is to study the effect of peginterferon alpha and ribavirin on spermatozoa in men using these medication.

Eligibility criteria: Inclusion Criteria:

* Written informed consent
* Treatment with peginterferon and ribavirin in the presence of a chronic Hepatitis C infection

Exclusion Criteria:

* Preexisting semen abnormalities.
* Concurrent use of drugs influencing sperm concentration,motility and morphology.
* Less then one million spermatozoa/ml in semen at screening.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus M C, University Medical Center Rotterdam
Study officials:
affiliation: Foundation for Liver Research
name: Robert J de Knegt, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02421432: Evaluation of the Safety and the Efficacy of Transanal TME in Difficult Cases
Official title: A Pilot Study for the Evaluation of the Safety and the Efficacy of Transanal Total Mesorectal Excision in Difficult Cases of Laparoscopic Surgery for Rectal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Keywords: trananal TME
safety
efficacy
difficult cases
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
First posted: 2015-04-20
Enrollment: 12
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is evaluation of the safety and the efficacy of transanal total mesorectal excision in difficult case.

Difficult case is defined as below;

- If any one of the following (1 or 2 or 3)

1. BMI: 30 or more
2. Tumor size: more than 7cm in long diameter
3. CRM: mesorectal fascia involvement or less than 1 mm on MRI

Detailed description: Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.

Eligibility criteria: Inclusion Criteria:

* age: 20-80 years
* biopsy-proven adenocarcinoma of the rectum
* clinical staging (c or yc): T0-3, N0-2, M0
* Rectal cancer located 3-12 cm from the anal verge
* ECOG performance status: 2 or less
* If any one of the following (1 or 2 or 3)

  1. BMI: 30 or more
  2. Tumor size: more than 7cm in long diameter
  3. CRM: mesorectal fascia involvement or less than 1 mm on MRI

Exclusion Criteria:

* Synchronous colon cancer or other malignancy
* Obstructing rectal cancer
* Pregnant or breast-feeding
* Receiving any other study agents
* Fecal incontinence
* History of prior colorectal cancer or inflammatory bowel disease

Primary outcomes:
measure: TME quality & circumferential resection margin (CRM)
timeFrame: the day of surgery
Secondary outcomes:
measure: 30-day postoperative complications
timeFrame: 1 month after surgery
measure: Number of harvested Lymph Nodes
timeFrame: the day of surgery
Other outcomes:
measure: 2-year local recurrence free survival
timeFrame: 2 years after surgery
measure: 5-year overall survival
timeFrame: 5 years after surgery
Locations:
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
Study officials:
affiliation: Korea: National Cancer Center
name: Dae Kyung Sohn, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00259532: Three New Methods for Diagnosing Pancreas Cancer
Official title: Ultrasound With Contrast Agent, 64-Slice-CT and Tumormarkers for Diagnosing, Evaluation of Operability and Treatment Control of Pancreas Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pancreas Cancer
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2005-11-29
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this project is to evaluate and compare three new methods for diagnosis, staging, operability evaluation and treatment control of pancreas cancer. The investigators use contrast-enhanced ultrasound combined with the gastrointestinal hormones Secretin and Cholecystokinin, which triggers the enzyme production of pancreas. The hormones induce an increased metabolism and thus an increased blood flow through healthy pancreas tissue, however, not in tumor tissue. The investigators hope to be able to use this effect diagnostically. The patients included will also have a 64-slice-CT in order to evaluate, if an increased diagnostic safety can be reached compared to an older CT scanning method. All patients will also be examined for the tumor marker CA 19-9. Further, the investigators will examine if contrast-enhanced ultrasound can contribute with information in treatment control after either surgery or medical treatment.


Eligibility criteria: Inclusion Criteria:

* suspicion of cancer of the pancreas

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital
Study officials:
affiliation: Department of Radiology, Section of Ultrasound
name: Michael B Nielsen, DMSc
role: PRINCIPAL_INVESTIGATOR
References: