louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01176838: A 5 Year Follow-up on Newly Diagnosed Breast Cancer Patients
Official title: A Prospective Study on Newly Diagnosed Breast Cancer Patients: A 5 Year Follow Up on Quality of Life
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Newly Diagnosed Breast Cancer
Keywords: Breast Cancer Quality of Life Survey
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2010-08-06
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of females ages 18 and over that have been newly diagnosed with breast cancer.

Brief summary: The purpose of this study is to provide the physicians with quality long term follow up data on subjects from the Breast Cancer Clinic and the Plastic Surgery Clinic who have been newly diagnosed with breast cancer and will receive treatment for the cancer at this facility. Over the last two decades many studies have been done concerning the quality of life after a mastectomy and/or reconstruction process. The majority of these studies only run for one year post reconstruction, some however, do include a two year follow up. The investigators are proposing a 5 year long term follow up study on subjects who will be diagnosed and treated here at the Breast Cancer Clinic and the Plastic Surgery Clinic. The investigators first questionnaire will be given prior to any treatment for breast cancer, giving us a baseline for the subject's current quality of life. At each successive year, the subject will be given another questionnaire with regards to their progression through the reconstructive process. At the end of 5 years, the subject will complete a final questionnaire. These questionnaires will deal with many areas of daily life functions; activities of daily living, anxiety, depression, social interactions, personal and sexual relationships.

Detailed description: Upon informed consent of subject, a baseline questionnaire will be completed by the subject. At years 1, 2, 3, and 4 follow up questionnaires will be sent for completion to the subject. At year 5 a final questionnaire will be sent to the subject for completion.After all subjects have completed the study, data will be sent to the Department of Biostatics for analysis.

Eligibility criteria: Inclusion Criteria:

Any female age 18 or over that has been diagnosed with breast cancer and has been treated and followed in the Breast Cancer Clinic and the Plastic Surgery Clinic is eligible for study participation.

Exclusion Criteria:

Any person not meeting these requirements will not be eligible for study participation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Department of Plastic & Reconstructive Surgery
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Lisa R David, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06775938: ChatGPT Versus Physical Medicine and Rehabilitation Residents
Official title: Can Artificial Intelligence Take Place of Physical Medicine and Rehabilitation Physicians?: ChatGPT Versus Physical Medicine and Rehabilitation Residents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Artificial Intelligence (AI)
Resident Education
Keywords: Artificial Intelligence
ChatGPT
Educational Technology
Physical and Rehabilitation Medicine
Rehabilitation
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2025-01-15
Enrollment: 314
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study used exam questions taken by the majority of residents enrolled in the PMR specialization training program held throughout Turkey in May 2024. These exam questions were selected from a pool of questions developed by lecturers affiliated with the PMR departments of hospitals affiliated with the University of Health Sciences. The exam questions were structured to cover four different difficulty levels.

Brief summary: The aim of this study was to assess the performance of ChatGPT on examinations administered to physical medicine and rehabilitation (PMR) residents.

Detailed description: These exams for resident physicians are annual exams administered throughout the training period, which constitute a fundamental component of the training process towards becoming a PMR physician. In this study, we evaluated the performance of ChatGPT in these exams, made separate assessments for each training year, and compared the results of ChatGPT with the results of residents who passed the same exam.

Eligibility criteria: Inclusion Criteria:

* Physical medicine and rehabilitation residents exam results in May 2024

Exclusion Criteria:

-

Primary outcomes:
measure: The comparison of resident exam results and ChatGPT answers to the same questions
timeFrame: through study completion, an average of 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Şişli Hamidiye Etfal Training and Research Hospital
state: Sarıyer
Study officials:
References:
Clinical trial NCT03216408: Clinical Study to Evaluate the Efficacy and Safety of Neuronox and Botox With Moderate to Severe Glabellar Lines
Official title: A Multicenter, Double-blind, Randomized, Parallel, Active-controlled, Phase III Study to Evaluate the Efficacy and Safety of NEURONOX® vs. BOTOX® in Patients With Moderate to Severe Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glabellar Lines
Lead sponsor: Medy-Tox
Sponsor class: INDUSTRY
First posted: 2017-07-13
Enrollment: 504
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical study evaluates the efficacy and safety of Neuronox compared with Botox in adults with moderate to severe glabellar lines.

Detailed description: Subjects are randomly assigned into the two groups at the ratio of 2:1. The purpose of study is to confirm the non-inferiority of Neuronox to Botox in terms of the efficacy and safety in subjects with moderate to severe glabellar lines.

Eligibility criteria: Inclusion Criteria:

* Subjects aged between 18 and 65
* Subjects with more than grade 2 (moderate) in the investigator's rating of the severity of glabellar lines at maximum frown

Exclusion Criteria:

* Subjects with medical conditions who may be greater risk due to the administration of the investigational drugs
* Subjects with skin disorders at the injection site

Primary outcomes:
measure: 4-grade scale by live assessment of glabellar line severity
timeFrame: 4 weeks after injection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05009108: Establishing of the Reliability of the Purdue Pegboard Test in Adults After a Stroke
Official title: Establishing of the Reliability of the Purdue Pegboard Test in Adults After a Stroke
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Motor Activity
Keywords: Standardized test
Occupational therapy
Fine motor skills
Purdue Pegboard Test
Czech language
Inter-rater reliability
Internal variability
Stroke
Adults
Lead sponsor: Charles University, Czech Republic
Sponsor class: OTHER
First posted: 2021-08-17
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Czech adult patients after a stroke

Brief summary: The main aim of the pilot project is to establish inter-rater reliability, internal variability and variability of results got by testing adults patients after a stroke by the use of Purdue Pegboard Test administered according to the new Czech extended version of its manual.

Detailed description: New Czech manual for the Purdue Pegboard Test which is updated and extended by new rules for unification of their performing will be used for testing adult people with disability - adults after a stroke. The manuals include instructions for performing three trials of each subtest.

At least 30 adult patients after a stroke will be tested by use of Purdue Pegboard test administrated according to the new Czech extended version of its manual. Video of performance of each adult will be obtained. Performance of each patient, firstly in real time and secondly from video record will be evaluated twice, to obtain result for establishing all types of variability and reliability mentioned below.

The inter-rater reliability, internal variability and variability of results will be established.

Eligibility criteria: Inclusion Criteria:

* Czech language as a mother tongue
* age from 18 to 65 years
* patient after a stroke hospitalized at Rehabilitation institute Kladruby
* fine motor skills allowing them correct manipulation with components of Purdue Pegboard Test

Exclusion Criteria:

* severe disorder of orientation (neglect syndrome)
* use of drugs affecting attention
* vision impairment uncorrectable with glasses
* severe hearing loss
* inability to understand instructions
* inability to read or write
* inability to complete complete testing due to severe spasticity or spastic dystonia
* failure to sign Informed consent for probation with inclusion to research and Consent to the collection and processing of personal data during the study at the Rehabilitation institute Kladruby

Primary outcomes:
measure: results from the Purdue Pegboard Test
timeFrame: 25 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Kladruby
country: Czechia
facility: Rehabilitační ústav Kladruby
city: Praha
country: Czechia
facility: Department of Rehabilitation Medicine, First Faculty of Medicine, Charles University and General University Hospital in Prague
Study officials:
References:
Clinical trial NCT01319708: Mild Versus Conventional Ovarian Stimulation for Poor Responders Undergoing In Vitro Fertilisation
Official title: Mild Versus Conventional Ovarian Stimulation for Poor Responders Undergoing In Vitro Fertilisation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Infertility
Keywords: ovarian stimulation
climiphene citrate
Gonadotropin-Releasing Hormone agonists/antagonists
Follicle Stimulating Hormone
Lead sponsor: National and Kapodistrian University of Athens
Sponsor class: OTHER
First posted: 2011-03-22
Enrollment: 50
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators will examine the balance between IVF success in terms of outcome parameters, using a mild ovarian stimulation protocol, opposing it to the conventional stimulation regimens in poor responders undergoing IVF.


Eligibility criteria: Inclusion Criteria:

* poor responders (age\>40, previous POR, abnormal OR test)
* indication for IVF
* regular cycling patients
* BMI 19-35

Exclusion Criteria:

* contraindication for clomiphene citrate use or to GnRH agonists antagonists
* BMI \> 35

Primary outcomes:
measure: number of oocytes (COCs)
timeFrame: at oocyte recovery
Secondary outcomes:
measure: Number/rate of participants whom the IVF cycle was cancelled
timeFrame: After the 1st week of ovarian stimulation, no oocytes at OR
measure: clinical pregnancy rate
timeFrame: 6 weeks
measure: live birth
timeFrame: more than 20 weeks
measure: miscarriage
timeFrame: pregnancy loss before 20 weeks of gestation, after a positive pregnancy test
measure: stimulation characteristics
timeFrame: from start of stimulation until embryo transfer
measure: cancellation rate
timeFrame: from start of stimulation until ET
Other outcomes:
Locations:
city: Athens
country: Greece
facility: 3rd Department of Obstetrics & Gynecology, Assisted Reproduction Unit
state: Chaidari
Study officials:
References:
Clinical trial NCT06344208: Predicting Toxicity in Elderly Patients With Head and Neck Cancer
Official title: Predicting Toxicity in Elderly Patients With Head and Neck Cancer: Validating a Disease-oriented Toxicity Predictive Tool and Integrating it With Available Screening Tools for Better Outcomes
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Cancer
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2024-04-03
Enrollment: 3
Sex: ALL
Minimum age (years): 70
Maximum age (years): 99
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 300 pts from the outpa-tients oncology practice previously discussed at multisciplinary meeting (MD) All the patients with age ≥ 70 years old, diagnosed with HNC candidated to a curative treatment with radiotherapy +/- systemic therapy (chemotherapy or cetuximab) will be evaluated.

Brief summary: Predicting toxicity in elderly patients with head and neck cancer:

validating a disease-oriented toxicity predictive tool and integrating it with avail-able screening tools for better outcomes.

Detailed description: We aim to analyze clinical and biochemical variables to prospectively create and validate an independ-ent predictive score to identify the probability of G3-5 toxicity in HNC elderly patients candidated to a curative treatment with radiation treatment +/- systemic treatment.

Eligibility criteria: Inclusion Criteria:

* Patients aged ≥ 70 years
* Histological diagnosis of squamous cell or undifferentiated HNC in stage III-IV AJCC ed VIII (si-nonasal, nasopharynx, oral cavity, oropharynx, unknown primary with HPV pos, larynx and hy-popharynx) and candidated to curative non surgical treatment (radiotherapy alone, Chemora-diation with platinum salts; radiation+cetuximab)
* Evaluable disease accordingly to RECIST criteria 1.1
* Willing of sign a written informed consent
* Adequate organ function

Exclusion Criteria:

Patient with cancer in other sites than HN \< than 2 years except for prostate cancer cT1-2, Gleason 3+3, NIMBC, initial Non Melanoma Skin Cancer, in situ cervical cancer)

* PS ECOG 3-4
* Patients who received systemic treatments in the past for other primary tumors

Primary outcomes:
measure: Predicting toxicity in elderly patients with head and neck cancer
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
References:
Clinical trial NCT06853808: Prediction Model for Delayed Extubation of Tracheal Intubation in Patients With Maxillofacial Space Infection After Abscess Incision and Drainage Surgery
Official title: Prediction Model for Delayed Extubation of Tracheal Intubation in Patients With Maxillofacial Space Infection After Abscess Incision and Drainage Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Oral Infection
Keywords: oral infection
Lead sponsor: Henan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with oral and maxillofacial space infection

Brief summary: Retrospective exploration of the risk factors associated with mechanical ventilation and tracheal extubation twenty-four hours after abscess incision and drainage surgery in patients with maxillofacial space infection.

Detailed description: 1. Retrospective exploration of the risk factors associated with mechanical ventilation and tracheal extubation after 24 hours of abscess incision and drainage in patients with maxillofacial space infection.
2. Prediction model: Based on the identified risk factors, establish a model to predict the risk of tracheal intubation withdrawal 24 hours after abscess incision and drainage surgery in patients with maxillofacial space infection.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old (actual age of the patient)
* Patients diagnosed with maxillofacial space infection upon admission

Exclusion Criteria:

* Serious errors or omissions in key demographic information and medical records

Primary outcomes:
measure: Time for extubation of endotracheal tube after surgery
timeFrame: 24hour
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Department Director
name: jiaqiang zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02741908: Fixed Diet Plan and Calorie Counting Diet in Adolescents
Official title: Effects of Two Diet Techniques and Delivery Mode on Weight Loss, Metabolic Profile and Food Intake of Obese Adolescents: a Fixed Diet Plan and a Calorie Counting Diet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 66
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Obesity is a chronic illness and multifactorial etiology, related to genetic factors, environmental and behavioral. Features association with several metabolic abnormalities in childhood, leading to increased risk of cardiovascular disease in adult life. The treatment involves lifestyle change, with balanced diet guidance and encouraging physical activity. The treatment in this age group have brought limited data, in addition to high drop-out rates. A unique type of food guidance is the equivalent calorie count, where calories are converted into points. The objective of this study was to evaluate the variance of Z score of body mass index (ZIMC) of obese adolescents undergoing orientation of two groups of low-calorie diet: traditional and based on the points system, as well as evaluate anthropometric variables, body composition, food intake, metabolic changes and self-monitoring.

METHODS: randomized clinical study with duration of 24 weeks, with 66 adolescents with an average age of 13.7 ± 0.7 years of both genders, with scores of BMI \>= 2 to \<= 4 curve adjusted for gender and age of the World Health Organization. Were verified weight, height, blood pressure and waist circumference, intensity of physical activity and self- monitoring, as well as performed the nutritional guidance to each visit. Laboratory parameters, applying the scale of binge eating, pubertal, stage and body composition were evaluated at the beginning and end of the action. The patients were divided into two groups: one that received guidance of traditional low-calorie diet and meet the food consumption record (RCA), three days (Group A) and another that received low-calorie diet guidance based on the system of points and meet the daily RCA (Group B).


Eligibility criteria: Inclusion Criteria:

* Age 12 to 15 years old
* ZBMI ≥+2.0 according to World Health Organization

Exclusion Criteria:

* ZBMI≥+4
* obesity related to genetic syndromes
* End-organ damage
* Taking drugs that promote weight changes

Primary outcomes:
measure: Z-score body mass index
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00920608: A Study to Assess the Pharmacokinetics of Methotrexate Given With and Without AZD9056 in Rheumatoid Arthritis Patients
Official title: A Phase I, Multi-centre, Open-label, Fixed-sequence Study to Assess the Pharmacokinetics of Methotrexate Alone and When Co-administered With AZD9056 in Subjects With Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Keywords: AZD9056
Pharmacokinetics
interaction
Methotrexate
Rheumatoid Arthritis
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-06-15
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main aim of this clinical study is to investigate whether the blood concentration of methotrexate changes when AZD9056 is co- administered together with methotrexate.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with rheumatoid arthritis
* Currently on Methotrexate treatment
* Provision of informed consent

Exclusion Criteria:

* History of malignancy (except for treated squamous and basal cell carcinoma of the skin more than 5 years prior to entry)
* Patients who were taking prescription of medications listed below:

Medications that are hepatic enzyme inducers and that were inhibitors of cytochrome P450, Lovastatin

* Leflunomide, hydroxychloroquine, cyclosporin or anti-tumour necrosis factor therapies within 90 days of Visit 1, or treatment with rituximab within 1 year before Visit 1

Primary outcomes:
measure: Pharmacokinetics of AZD9056 and Methotrexate
timeFrame: Pharmacokinetic samples for Methotrexate taken at baseline and and at steady state.Pharmacokinetc samples for AZD9056 taken at steady state
Secondary outcomes:
measure: Pharmacokinetics of AZD9056 and 7-OH Methotrexate
timeFrame: Pharmacokinetics samples for 7-OH Methotrexate taken at baseline and and at steady state.Pharmacokinetc samples for AZD9056 taken at steady state
measure: Safety and tolerability (Physical examination, vital signs, electrocardiogram (ECG), safety laboratory,adverse events.)
timeFrame: During the whole study
Other outcomes:
Locations:
Study officials:
References: