louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04980118: A Nutritional Intervention and Physical Activity Program Reduce Body Weight in Women Newly Diagnosed With Breast Cancer.
Official title: A Standardized Integral Nutritional Intervention 1 and Physical Activity Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Body Weight Changes
Weight Loss
Nutrition Related Cancer
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate a nutritional intervention for women newly diagnosed with breast cancer on a weight control and physical activity program.

Detailed description: 56 women newly diagnosed with breast cancer from the Department of Medical Oncology of La Paz University Hospital, Madrid, Spain.

A nutritional and physical activity intervention program that consisted of two individual nutritional consults and five nutritional group lectures was conducted by physicians of the Nutrition Unit during one year.

Eligibility criteria: Inclusion Criteria:

* Years: ≥18
* Sex: Female
* Newly diagnosed breast cáncer

Exclusion Criteria:

* Patients who have disseminated disease.
* Associated eating behavior disorders.
* Patients with dementia, mental illness or decreased cognitive function.
* Consumption of drugs or substances to lose weight (except in those cases in which it is suspended 15 days before starting the study).
* Presence of disease that may interfere with weight loss: severe psychiatric illness, uncontrolled hypothyroidism.
* Pregnant or breastfeeding women.

Primary outcomes:
measure: To evaluate a nutritional intervention for women newly diagnosed with breast cancer 9 weight control and physical activity program.
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Institute for Health Research IdiPAZ
Study officials:
affiliation: Hospital Universitario La Paz
name: Carmen Gómez Candela, Msc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01203618: Exploratory Study of Farletuzumab to Treat Resectable, Non-functioning Pituitary Adenomas
Official title: Exploratory Phase 2 Study of Farletuzumab in Resectable Non-functioning Pituitary Adenoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Resectable, Non-functioning Pituitary Adenoma
Keywords: Resectable, non-functioning pituitary adenoma
Pituitary tumor
Pituitary adenoma
Pituitary macroadenoma
Lead sponsor: Morphotek
Sponsor class: INDUSTRY
First posted: 2010-09-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
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 to evaluate whether therapy with farletuzumab is effective and safe in the treatment of resectable, non-functioning pituitary adenomas.

Detailed description: Non-functioning pituitary adenomas are the most frequent type of pituitary tumors, defined by the lack of hormonal overproduction from the tumor. Non-functioning macroadenomas are \> 1 cm in size that can cause progressive visual loss, headaches, and symptoms of pituitary dysfunction (hypopituitarism and/or hyperprolactinemia). Initial treatment for these type of tumors is trans sphenoidal surgical resection. In cases where the outcome is incomplete surgical resection of the tumor, repeat surgery and external beam radiation therapy may be performed. Previous clinical work suggests there may be a role for a folate receptor in the treatment of non-secretory, pituitary adenomas. MORAb-003 is a monoclonal antibody that has the potential to be an effective agent against resectable, non-functioning pituitary adenomas. MORAb-003 has been shown to be well tolerated. This study allows the opportunity to determine if therapy with farletuzumab is effective and safe.

Eligibility criteria: Inclusion Criteria:

* Males and females \>18 years old
* Diagnosis of non-functional pituitary adenoma
* Able and willing to undergo surgical resection of the pituitary tumor
* Significant medical conditions must be well-controlled and stable for at least 30 days prior to signing the informed consent form

Exclusion Criteria:

* Presence of clinically significant pituitary apoplexy
* Presence of hormone-secreting adenomas
* Presence of compressive optic neuropathy due to pituitary tumor
* No prior surgical, medical, or radiation therapy in the last 6 months

Primary outcomes:
measure: Efficacy of farletuzumab in subjects with resectable, non-functioning pituitary macroadenomas as measured by objective response in the tumor size.
timeFrame: Every 3 months
Secondary outcomes:
measure: Safety and tolerability of farletuzumab in this patient population.
timeFrame: Weekly for the first 3 months followed by every 2 weeks for 12 months
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Morphotek
name: Bruce Wallin, MD
role: STUDY_DIRECTOR
affiliation: Emory University
name: Nelson Oyesiku, MD, PhD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05658718: Factors Influencing Nocturnal Symptoms After Refractive Surgery.
Official title: Effects of Different Pupil Size Under Light and Dark Conditions on Nighttime Symptoms After Refractive Surgery.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Refractive Surgery
Visual Quality
Keywords: refractive surgery
glare
pupil
visual quality
Aberrations
Lead sponsor: Second Affiliated Hospital of Nanchang University
Sponsor class: OTHER
First posted: 2022-12-21
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People undergoing refractive surgery.

Brief summary: By comparing the parameters of the two groups of patients with glare at night after refractive surgery and those without glare at night, the influence of preoperative related parameters on postoperative glare was analyzed.


Eligibility criteria: Inclusion criteria：

* Age ≥18 years old；
* Stable diopter (diopter change less than 0.5D in the past 2 years);
* Best corrected distance visual acuity (CDVA) of 1.0 or better；
* Anterior chamber depth (ACD) ≥2.8 mm;
* Corneal endothelial cell density (ECD) ≥ 2 000 cells/mm.

Exclusion criteria:

* History of ocular trauma or surgery;
* Suspected keratoconus;
* Previous history of other ocular diseases such as corneal inflammation or edema, glaucoma, uveitis, retinal detachment, macular degeneration, cataract, amblyopia, etc.;
* History of severe dry eye；
* Patients with systemic diseases, such as hyperthyroidism or autoimmune diseases; or severe mental disorders, such as anxiety and depression.

Primary outcomes:
measure: Changes of diopter under bright and dark pupils.
timeFrame: Preoperative
measure: Changes of diopter under bright and dark pupils.
timeFrame: Day 7
measure: Changes of diopter under bright and dark pupils.
timeFrame: Month 1
measure: Changes of diopter under bright and dark pupils.
timeFrame: Month 3
measure: Changes of diopter under bright and dark pupils.
timeFrame: Month 6
measure: objective visual quality.
timeFrame: Day 7
measure: objective visual quality.
timeFrame: Month 1
measure: objective visual quality.
timeFrame: Month 3
measure: objective visual quality.
timeFrame: Month 6
measure: subjective visual quality
timeFrame: Day 7
measure: subjective visual quality
timeFrame: Month 1
measure: subjective visual quality
timeFrame: Month 3
measure: subjective visual quality
timeFrame: Month 6
measure: ICL Vault
timeFrame: Day 7
measure: ICL Vault
timeFrame: Month 1
measure: ICL Vault
timeFrame: Month 3
measure: ICL Vault
timeFrame: Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The Second Affiliated Hospital of Nanchang University
state: Jiangxi
Study officials:
References:
Clinical trial NCT00610818: Effect of Palifermin on Skin Tumors in Patients Undergoing Bone Marrow Transplantation
Official title: Effect of Palifermin Therapy on Benign and Malignant Skin Tumors in Patients Undergoing High-Dose Chemotherapy With Autologous Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Skin Rash
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2008-02-08
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients receiving palifermin for bone marrow transplantation.

Brief summary: We are approaching you to participate in this study because you are taking Palifermin and the purpose of this study is to describe the effect of Palifermin on skin growth found on the body. Palifermin is a new synthetic growth factor (encourages skin cells to grow) specifically designed to protect the areas of the body (mouth and upper digestive tract) that are damaged by chemotherapy. The cells in these areas are rapidly dividing cells and so are killed by chemotherapeutic drugs. Palifermin is a drug that stimulates new cells in these areas to grow and therefore protects patients from some serious side effects of chemotherapy. These include mucositis or inflammation of the lining of the mouth and other organs resulting in difficulty swallowing, speaking and extreme pain in the mouth and upper digestive tract.

Skin cells are also known to respond to these types of growth factors like Palifermin, but unfortunately no studies have been done that look specifically at the effect of this drug on pre-existing skin lesions or the development of new skin lesions. We will be asking you if you have noticed any change in moles or other skin lesions that you have, and if you have noticed any new lesions. We will also be doing a full physical examination of the skin at regular intervals during the study to document the appearance of any new lesions or change in pre-existing ones.


Eligibility criteria: Inclusion Criteria: receiving bone marrow transplant -

Exclusion Criteria: not receiving other growth factors

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University
state: Quebec
Study officials:
affiliation: McGill University
name: beatrice wang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05004818: Galvanic Vestibular Stimulation as a Novel Treatment for Seasickness
Official title: Galvanic Vestibular Stimulation as a Novel Treatment for Seasickness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Motion Sickness
Seasickness
Habituation
Vestibular Time Constant
Keywords: Motion Sickness
Seasickness
Galvanic vestibular stimulation
Rotatory chair
Vestibular time constant
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
First posted: 2021-08-13
Enrollment: 54
Sex: MALE
Minimum age (years): 19
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: subjects with severe seasickness, who failed to habituate to sea conditions after at least six month of active sailing, were enrolled to the single-blind randomized control study. The intervention group was treated with rotatory chair stimulation at sinusoidal harmonic acceleration protocol coupled with galvanic vestibular stimulation to the mastoid processes. This unique procedure was hypothesized to promote habituation to seasickness. The control group underwent a sham procedure. All study participants filled out seasickness questionnaires at set time points following the intervention and underwent repeated step testing to determine their vestibular time constant. The number of anti-motion sickness clinic visits and scopolamine prescriptions was also recorded in the three months period following the intervention.


Eligibility criteria: Inclusion Criteria:

* maximum score of 7 on the Wiker seasickness questionnaire in moderate sea conditions, with wave height of 0 - 1.5 m
* All had been sailing regularly for at least six months before enrolling in the study

Exclusion Criteria:

* history of hearing loss
* otoscopic findings of ear pathology
* an implanted electrode
* a finding of vestibulopathy on otoneurologic examination
* withdrawal by any subject of his informed consent.

Primary outcomes:
measure: Vestibular time constant
timeFrame: Until one month following the intervention
measure: Seasickness severity
timeFrame: Until one month following the intervention
measure: scopolamine drug prescription
timeFrame: Until three months following the intervention
measure: Anti-motion sickness clinic visits
timeFrame: Until three months following the intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Israel Naval Medical Institute, IDF Medical Corps, Haifa, Israel
name: Dror Tal, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gutkovich YE, Lagami D, Jamison A, Fonar Y, Tal D. Galvanic vestibular stimulation as a novel treatment for seasickness. Exp Brain Res. 2022 Feb;240(2):429-437. doi: 10.1007/s00221-021-06263-w. Epub 2021 Nov 15.
Clinical trial NCT06770218: Effects of Pelvic Girdle Stabililty With Use of Therapeutic Taping in Down Syndrome
Official title: Effects of Pelvic Girdle Stability Training With and Without Therapeutic Taping on Trunk Control in Childern With Down Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Down Syndrome
Keywords: Down syndrome
therapeutic taping
trunk control
pelvic girdle
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 16
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: it will be randomized contrail in which non probability convenient sampling will be used two groups of A and B .Group A will given therapeutic training nd B group pelvic girdle training without therapeutic training
Primary purpose: TREATMENT

Brief summary: A Interventional study on 16 down syndrome pateints and check effects o therapeutic taping on pelvic girdle stability on 8 weeks sessions

Detailed description: Study group A will undergo pelvic girdle stablilty traing along with therapeutic taping and group B will receive pelvic girdle satbility traing of 8 weeks and chcek the effects by trunk control assessement tool,gross motor functional scale .this study type is conviennet sampling techniques and check effetcts by exercising

Eligibility criteria: Inclusion Criteria:

* Functional hearing and vision
* Ability to understand commands.

Exclusion Criteria:

* Children with severe mental retardation
* History of trauma and surgery'

Primary outcomes:
measure: trunk control assesment scale
timeFrame: 6 weeks
Secondary outcomes:
measure: GMFCS-88
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Riphah international university. lahore pakistan.
state: Punjab
city: Lahore
country: Pakistan
facility: Riphah international university
state: Punjab
Study officials:
affiliation: Ripah International university
name: Maham Javed, MS*
role: PRINCIPAL_INVESTIGATOR
References:
citation: Giustino V, Messina G, Alesi M, La Mantia L, Palma A, Battaglia G. Study of posturalcontrol and body balance in subjects with Down syndrome. Human Movement. 2021;22(1):66-71.
Clinical trial NCT06735118: Feasibility Study of Deep Learning-based MDixon Quant for Quantitative Assessment of Chemotherapy-induced Fatty Liver
Official title: Feasibility Study of Deep Learning-based MDixon Quant for Quantitative Assessment of Chemotherapy-induced Fatty Liver
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Lead sponsor: Yunnan Cancer Hospital
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to quantitatively assess the changes in liver fat content in cancer patients before and after treatment.

The main questions it aims to answer are:How does the liver fat fraction change before and after chemotherapy? In this study, patients undergoing mDixon Quant scanning are subjected to fully automated segmentation and measurement of liver fat content using artificial intelligence.

Detailed description: Regarding the extraction of liver fat fraction, the traditional axial ROI method involves selecting several regions of interest (ROIs) at the largest cross-sectional level or across multiple continuous sections, and taking the average value as the whole-liver fat fraction. This method is complex, time-consuming, and cannot obtain the whole-liver fat fraction. In this study, a threshold extraction method is used to obtain the whole-liver fat fraction, enabling a 2D-to-3D conversion, which is more time-efficient and labor-saving, and provides a more accurate measurement.

Eligibility criteria: Inclusion Criteria:

1. CT/B ultrasound showed no fatty liver
2. No MRI contraindications, including pacemaker, stent, metal implant, or claustrophobia
3. Received neoadjuvant/adjuvant chemotherapy

Exclusion Criteria:

1. Missing follow-up information
2. Liver lesions (metastases, hemangioma, etc.)
3. Poor image quality

Primary outcomes:
measure: Extract the whole liver fat fraction
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Kunming
country: China
facility: Yunnan Cancer Hospital
state: Yunnan
Study officials:
affiliation: Ethics Committee of Yunnan Provincial Cancer Hospital
name: Lianhua Ye
role: STUDY_DIRECTOR
References:
Clinical trial NCT00005518: Epidemiology and Immunology of Hemophilia A Inhibitors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Disease
Hemophilia A
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To determine the risk factors associated with inhibitor formation in hemophilia A and to study the mechanism of tolerance in the murine hemophilia A model.

Detailed description: BACKGROUND:

The major hypothesis of this study is that suppression of immunoregulatory cytokines will prevent factor VIII inhibitor formation in the hemophilia A murine model: if successful, a treatment protocol could be developed for individuals identified to be at highest risk for inhibitor formation. Through this approach to the epidemiology and immunology of inhibitor formation, the health care of individuals with hemophilia may be improved.

The study is in response to a Request for Applications released in 1998 on the Immunogenetics of Inhibitor Formation in Hemophilia. .

DESIGN NARRATIVE:

A case-control study is conducted comparing prevalent hemophilia patients with inhibitors identified in the HMS Study with three age-matched controls without inhibitors to determine clinical and laboratory characteristics associated with inhibitor development. A histocompatibility study is conducted identifying patterns of HLA Class II antigens by molecular typing in hemophilic subjects identified in HMS, with and without inhibitors, which may be linked to inhibitor formation. An animal tolerance study is conducted in the hemophilia A murine model, evaluating blockade of T cell costimulatory pathways by CTLA4-Ig and anti-CD40L mAb, to prevent inhibitor formation.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh
name: M.V. Ragni
References:
Clinical trial NCT06066918: Prophylactic Pregabalin Treatment Following Spinal Cord Injury
Official title: The Effect of Preventional Drug Therapy on Pain Regulation Mechanisms Among Spinal Cord Injury Patients Who Have Yet to Develop Central Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries
Spinal Cord Diseases
Lead sponsor: Loewenstein Hospital
Sponsor class: OTHER
First posted: 2023-10-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: allocation will be sequential. 2 patients will be in the study group, followed by one patient at the control group.
Primary purpose: PREVENTION

Brief summary: Patients arriving to rehabilitation up to 3 months following SCI will be given (study group) or not (control group) Lyrica (75X2). They will be followed for central pain development.

Detailed description: Patients arriving to rehabilitation up to 3 months following SCI will be recruited, if they have not yet developed central pain. Two thirds (the study group) will be treated with Lyrica (Pregabalin75X2) for 3 months. One third (the control group) will not receive preventative treatment. Participants will be followed for central pain development.

Eligibility criteria: Inclusion Criteria:

* Up to 3 months following traumatic or non-traumatic SCL
* Ability to give informed consent and cooperate

Exclusion Criteria:

* Pregnancy
* Neurological or other medical conditions that may interfere with sensation
* Neuropathic-like pain before recruitment (described as painful sensation of electric current, burning, numbness, tingling, pricking, or squeezing)
* Being treated with Pregabalin
* Blood creatinine levels \>1.2 or creatinine clearance \<60
* Sensitivity to lactose

Primary outcomes:
measure: Central pain
timeFrame: 1 year
measure: McGill Pain Questionnaire
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ra'anana
country: Israel
facility: Loewenstein Rehabilitation Hospital
Study officials:
affiliation: Loewenstein Rehabilitation Hospital
name: Amiram Catz, Catz
role: PRINCIPAL_INVESTIGATOR
References: