louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01701180: Neural Correlates of Empathogenic and Affiliative Actions of Oxytocin
Official title: Neural Correlates of the Empathogenic and Affiliative Actions of Oxytocin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Healthy
Keywords: Male Volunteers
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2012-10-04
Enrollment: 23
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Mounting evidence indicates that the intranasal administration of the neuropeptide oxytocin has prosocial effects. However, the neural substrates of these effects are still unclear. The investigators hypothesized that a single dose administration of oxytocin should increase empathogenic and affiliative responses and that these effects are mediated by an increased insula activity.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers
* In a heterosexual relationship

Exclusion Criteria:

* Current or past psychiatric disease
* Current or past physical illness
* Psychoactive medication
* Tobacco smokers

Primary outcomes:
measure: Empathy ratings and their neural correlates
timeFrame: About one hour after the intranasal administration of oxytocin
Secondary outcomes:
measure: Neural correlates of pair-bonding
timeFrame: About one hour after the intranasal administration of oxytocin
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Department of Psychiatry, University of Bonn
state: North Rhine-Westphalia
Study officials:
affiliation: Department of Psychiatry University of Bonn
name: René Hurlemann, MD PhD M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00311480: Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two(Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccines in Non-Elderly Adult and Elderly Subjects
Official title: A Phase II, Randomized, Controlled, Observer-Blind, Multi-Center Study to Evaluate Safety and Immunogenicity of Two Doses, Administered Three Weeks Apart, of Two (Surface Antigen Adjuvanted With MF59C.1) Influenza Vaccines Containing 7.5 mg or 15 mg of H5N1 Influenza Antigen, in Non-Elderly Adult and Elderly Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pandemic Influenza Disease
Keywords: influenza
pandemic influenza
influenza vaccine
adjuvanted influenza vaccine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2006-04-06
Enrollment: 520
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The present study aims to evaluate safety and immunogenicity of two doses, administered three weeks apart, of two influenza vaccines containing 7.5 micrograms or 15 micrograms of H5N1 influenza antigen, in non-elderly adult and elderly subjects.


Eligibility criteria: Inclusion Criteria:

* Male and female volunteers 18 years of age or older

Exclusion Criteria:

* any auto-immune disease or other serious acute, chronic or progressive disease
* hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine.
* history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine.
* within the past 7 days, they have experienced: any acute disease, infections requiring systemic antibiotic or antiviral therapy.

Primary outcomes:
measure: CPMP criteria for evaluation of flu vaccines e.g. Seroprotection, GMT's and Seroconversion rate at day 0 and day 22 and day 43 following vaccination
Secondary outcomes:
measure: Solicited Local and Systemic Reactions Within 6 Days Following Each Vaccination And Adverse Events Thought the Study.
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: G. D'Annunzio University
city: Genoa
country: Italy
facility: Department of Health Sciences
city: Lanciano
country: Italy
facility: ASL Lanciano-Vasto
city: Siena
country: Italy
facility: University Hospital of Siena
Study officials:
affiliation: Novartis Vaccines & Diagnostics
name: Drug Information Services
role: PRINCIPAL_INVESTIGATOR
References:
citation: Banzhoff A, Gasparini R, Laghi-Pasini F, Staniscia T, Durando P, Montomoli E, Capecchi PL, di Giovanni P, Sticchi L, Gentile C, Hilbert A, Brauer V, Tilman S, Podda A. MF59-adjuvanted H5N1 vaccine induces immunologic memory and heterotypic antibody responses in non-elderly and elderly adults. PLoS One. 2009;4(2):e4384. doi: 10.1371/journal.pone.0004384. Epub 2009 Feb 6.
Clinical trial NCT04221880: Erector Spinae Plane Block Versus Perioperative Intravenous Lidocaine for Thoracotomy
Official title: Erector Spinae Plane Block Versus Perioperative Intravenous Lidocaine for Postoperative Pain Control in Patients Undergoing Thoracotomy: A Prospective, Randomized, Double-blind Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Diseases
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2020-01-09
Enrollment: 60
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: Thoracotomy surgery is the most painful of all surgical procedures. Inadequate postoperative pain control in these patients may cause serious morbidity related to pulmonary, cardiovascular and emotional systems. Erector Spinae Plane Block (ESPB) was first described in 2016 and, it is frequently used for postoperative analgesia in thoracic surgery. Intravenous lidocaine exhibit analgesic activity through both the peripheral and central nervous system. Intravenous lidocaine has been shown to reduce postoperative pain intensity and accelerate postoperative recovery in many surgeries.

The investigators aimed to compare the effect of lidocaine infusion and erector spinae plane block on postoperative opioid consumption and pain scores.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologist's physiologic state I-III patients undergoing thoracotomy surgery

Exclusion Criteria:

* chronic pain, bleeding disorders, renal or hepatic insufficiency, non cooperative patient,
* Patients with allergies to one of the drugs used in the study.

Primary outcomes:
measure: Opioid Consumption
timeFrame: First 24 hours total opioid consumption
Secondary outcomes:
measure: Visual analog pain score
timeFrame: Postoperative 24 hour
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
References:
citation: Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12.
citation: Moeen SM, Moeen AM. Usage of Intravenous Lidocaine Infusion with Enhanced Recovery Pathway in Patients Scheduled for Open Radical Cystectomy: A Randomized Trial. Pain Physician. 2019 Mar;22(2):E71-E80.
Clinical trial NCT02306980: Oral Administration of Colostrum to Premature Babies: Impact on the Oral Microbiota
Official title: Oral Administration of Colostrum to Premature Babies: Impact on the Oral Microbiota
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Changes in the Oral Microbiota
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2014-12-03
Enrollment: 12
Sex: ALL
Minimum age (years): 12
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Oropharyngeal administration of mother's colostrum to premature infants has been proposed as a stimulus to the oropharyngeal lymphatic tissues to decrease the incidence of pneumonia and sepsis, particularly in intubated babies. We propose to study the impact of this intervention on the composition of the oral microbiota.


Eligibility criteria: Inclusion Criteria:

* premature infant with birth weight \< 1500
* intubated in the first 48 hours of life
* available maternal colostrum

Exclusion Criteria:

* lethal condition

Primary outcomes:
measure: Oral microbiota
timeFrame: Difference between enrollment, 48 hours and 96 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Children's Hospital
state: California
Study officials:
affiliation: UC Davis
name: Mark A Underwood, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sohn K, Kalanetra KM, Mills DA, Underwood MA. Buccal administration of human colostrum: impact on the oral microbiota of premature infants. J Perinatol. 2016 Feb;36(2):106-11. doi: 10.1038/jp.2015.157. Epub 2015 Dec 10.
Clinical trial NCT06668480: Effect of Sustained Natural Apophyseal Glide Combined With Strengthening Exercises of Lower Fibers of Trapezius in Patient With Unilateral Neck Pain
Official title: Effect of Sustained Natural Apophyseal Glide Combined With Strengthening Exercises of Lower Fibers of Trapezius in Patient With Unilateral Neck Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Neck Pain
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized controlled trial having two groups. One group will receive conventional physical therapy along with SNAGS and the second will receive SNAGS and strengthening of lower fibers of trapezius with conventional physical therapy. Both groups will be recruited concurrently.
Primary purpose: TREATMENT

Brief summary: Neck pain is considered one of the very common cause behind musculoskeletal pain and is 4th leading cause of disability . Cervical pain is among 5 most contributing factors in causing years lived with disability.Individuals with unilateral neck pain exhibit significantly less Lower Trapezius strength than Middle and Upper Trapezius fibers .Mulligan is one of the mobilization techniques that can be applied in case of neck pain.In prolong neck pain there is a hyperactivation and shortening of upper trapezius which makes the lower trapezius weak this leads to imbalance between cervical and scapular muscles and result in impaired biomechanics. So mostly treatment focused on upper trapezius and neglecting the lower trapezius and this create increase chances of recurrency of neck pain because the imbalance remains present. So, this study aims at evaluating the effects of SNAGS combined with strengthening exercises of lower fibers of trapezius .


Eligibility criteria: Inclusion Criteria:

* Individuals aged 18-35 years
* Both gender
* Unilateral neck pain
* Symptoms of duration more than 3 months.
* NPRS scoring of greater than or equal to 4 points.
* Neck disability index score of 20% or above.
* Manual muscle testing : grade 3

Exclusion Criteria:

* Prior cervical and thoracic spine fractures, dislocations, or surgeries, spinal osteoporosis or infection, or whiplash.
* Any trauma or localized infection in neck region
* Psychiatric diseases such as phobia/obsession and depression

Primary outcomes:
measure: Pain intensity
timeFrame: 2 weeks
measure: ROM
timeFrame: 2 weeks
measure: Level of Neck Disability
timeFrame: 2 weeks
measure: Muscle strength
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Foundation University College of Physical Therapy
state: Punjab
Study officials:
References:
Clinical trial NCT04279080: LARS in Ovarian Cancer Patients
Official title: Low Anterior Resection Syndrome (LARS) in Ovarian Cancer Patients - a Multi-centre Comparative Analysis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Anterior Resection Syndrome
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2020-02-20
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A cross-sectional multi-centre analysis was performed for female patients suffering from either rectal or EOC who received a low anterior resection as part of their therapy regimen.

Brief summary: Background:

Low anterior resection syndrome (LARS) is a common functional disorder after low anterior resection impacting quality of life. Data on LARS derives nearly exclusively from rectal cancer studies. Therefore, the study was designed to assess LARS in advanced epithelial ovarian cancer (EOC) patients, who underwent rectal resection and to compare it with a female rectal cancer cohort.

Methods:

A cross-sectional multi-centre analysis was performed for female patients suffering from either rectal or EOC who received a low anterior resection as part of their therapy regimen. None of the patients received pre- or postoperative radiotherapy. LARS was defined by using the validated LARS score and its severity was divided into "no", "minor" and "major LARS".


Eligibility criteria: Inclusion Criteria:

* low anterior resection because of ovarian or rectal cancer

Exclusion Criteria:

* neoadjuvant or adjuvant radiotherapy

Primary outcomes:
measure: functional bowel outcome after low anterior resection
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03311880: Evaluating a Cognitive Remediation Intervention for Women During the Menopausal Transition
Official title: Evaluating a Cognitive Remediation Intervention for Women During the Menopausal Transition: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopause
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 27
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal in this study is to evaluate the effectiveness of a cognitive remediation program that was designed specifically to address the concerns related to cognitive difficulties that are often reported among women in the menopausal transition. This cognitive remediation program has been created to provide our clients with an opportunity to learn more about the relation between menopause and cognitive function, to learn new strategies to enhance thinking skills (e.g., memory, attention) and to hear about lifestyle changes that are known to have a beneficial effect on mental functioning.


Eligibility criteria: Inclusion Criteria:

* Currently in menopausal transition
* Subjective cognitive complaints
* Presence of vasomotor menopausal symptoms (i.e., hot flashes)

Exclusion Criteria:

* Individuals with acute and severe depression
* Suicidal ideation
* Severe PTSD
* Psychosis
* Severe alcohol/substance use issues

Primary outcomes:
measure: change in self-reported cognitive difficulties
timeFrame: At the beginning of the first session and at the conclusion of the 5th session to assess change over time. That means measures will be administered 5 weeks later.
Secondary outcomes:
measure: Subjective distress
timeFrame: At the beginning of the first session and at the conclusion of the 5th session to assess change over time. That means measures will be administered 5 weeks later.
measure: Vasomotor symptoms
timeFrame: At the beginning of the first session and at the conclusion of the 5th session to assess for change over time. That means measures will be administered 5 weeks later.
measure: Beliefs
timeFrame: At the beginning of the first session and at the conclusion of the 5th session to assess for change over time. That means measures will be administered 5 weeks later.
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare
state: Ontario
Study officials:
References:
citation: Ballantyne EC, King JP, Green SM. Preliminary Support for a Cognitive Remediation Intervention for Women During the Menopausal Transition: A Pilot Study. Front Glob Womens Health. 2021 Dec 23;2:741539. doi: 10.3389/fgwh.2021.741539. eCollection 2021.
Clinical trial NCT06763380: Comparison of Ultrasound and Hysterosalpingography in Evaluation of Uterine Abnormality in Patients With Infertility
Official title: Comparison of Ultrasound and Hysterosalpingography in Evaluation of Uterine Abnormality in Patients With Primary and Secondary Infertility
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Uterine Abnormality
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2025-01-08
Enrollment: 3
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary and secondary infertile women using Ultrasound and Hysterosalpingography in Evaluation of Uterine Abnormality

Brief summary: The leading issue that every couple is experiencing in present era is infertility and it has become the major problem worldwide. Many hormonal disorders, weight, diet, and uterine abnormalities contributes in infertility.

Detailed description: To Compare diagnostic effectiveness of Ultrasound and Hysterosalpingography in detecting uterine abnormalities among Primary and Secondary Infertile women.

In order to obtain the necessary results, 73 patients were examined on Ultrasound and then referred for Hysterosalpingography at Radiology Department of Dr.Essa Lab and Punjab Radiology. Patients with Primary and secondary infertility between the age of 18 to 45 were included whereas pregnant women and women with PID and GTI were excluded. The data were collected utilizing the questionnaire and then processed in SPSS version 25.

Eligibility criteria: Inclusion Criteria:

* primary and secondary infertile women

Exclusion Criteria:

* Pregnant women. Women with PID

Primary outcomes:
measure: 2D Ultrasound Scan
timeFrame: 12 Months
measure: Hysterosalpingography test
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Dr. Essa Lab, High Q tower, Jail Road Lahore"
state: Punjab
Study officials:
References:
Clinical trial NCT01073280: Cerebral, Meningeal Biopsy by Flexible Endoscopy in Patients Without Neurological Diagnosis
Official title: Cerebral, Meningeal Biopsy by Flexible Endoscopy in Patients Without Neurological Diagnosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neurological Disease
Keywords: Cerebral and subarachnoid biopsy
flexible endoscopy
Patients with neurological findings without diagnosis.
Lead sponsor: Universidad Autonoma de San Luis Potosí
Sponsor class: OTHER
First posted: 2010-02-23
Enrollment: 40
Sex: ALL
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients between 0 and 85years old with neurological diseases that there are not a diagnosis

Brief summary: The investigators will take cerebral and subarachnoid biopsy by flexible endoscopy in patients without neurological findings. The investigators will use retrospective and prospective patients.

Detailed description: Test the useful of the flexible endoscopy in patients without neurological diagnosis.

Developed a diagnosis method for idiopathic neurological findings.

Compare the cerebral and subarachnoid biopsy each other

Eligibility criteria: Inclusion Criteria:

* patients with neurological disease and with out diagnosis

Exclusion Criteria:

* death of the patient
* patients with neurological diagnosis

Primary outcomes:
measure: Test the useful of the cerebral and subarachnoid biopsy by flexible endoscopy in patients without neurological findings
timeFrame: 2 weeks
Secondary outcomes:
measure: Developed a diagnosis method for idiopathic neurological findings. Compare the cerebral and subarachnoid biopsy each other
timeFrame: 2 weeks
Other outcomes:
Locations:
city: San Luis Potosi
country: Mexico
facility: Hospital Central Dr. Ignacio Morones Prieto
Study officials:
References:
Clinical trial NCT01107080: Fast Spectral Imaging Device for Tumor Margin Mapping
Official title: Fast Spectral Imaging Device for Tumor Margin Mapping
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast cancer
breast carcinoma in situ
ductal breast carcinoma in situ
invasive carcinoma
invasive ductal carcinoma
invasive lobular carcinoma
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2010-04-20
Enrollment: 54
Sex: FEMALE
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: There are 2 groups of patients and each group contains 20 participants.

Brief summary: The objective of the proposed research is to develop a clinical-trial-ready device and to evaluate its practical utility as a routinely used intra-operative tool. Our multidisciplinary group has previously shown that optical techniques can effectively discriminate between malignant and non-malignant breast tissues. The proposed technology will be a multi-channel optical assay device for intra-operative imaging of margins in specimens excised from patients undergoing breast conserving surgery (partial mastectomy) or mastectomy.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing a partial mastectomy or mastectomy for the treatment of an invasive or non-invasive breast malignancy
* Age \> 18
* Clinically detectable disease either by physical examination or radiographic studies
* Patients of all ethnic and gender groups will be included. Protocol accrual will be reviewed annually to include a determination of minority and gender representation. If accrual demonstrates under representation of any group with comparison to disease incidence in that group, appropriate measures will be undertaken to increase participation of patients of that minority or gender group.
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients considered in "vulnerable" populations

Primary outcomes:
measure: To perform a critical evaluation of the device in a practical clinical setting
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Nimmi Ramanujam, PhD
role: STUDY_CHAIR
References: