louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00337532: A Phase II Trial Neoadjuvant Paclitaxel and Cisplatin in Patients With Locally Advanced Head and Neck Cancer
Official title: A Phase II Trial Neoadjuvant Paclitaxel and Cisplatin in Patients With Locally Advanced Head and Neck Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Head and Neck Cancer
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2006-06-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical research study is to learn if a paclitaxel-cisplatin combination regimen given in the neoadjuvant setting is active in locally advanced head and neck cancer. the safety of this treatment will also be studied.


Eligibility criteria: Inclusion Criteria:

* Locally advanced, Stage II-IV (except M1), hand and neck cancer
* \> = 1 measurable lesion
* not been previously treated for head and neck cancer

Exclusion Criteria:

* history of another malignancy
* organ allografts
* pre-exiting neuropathy \> = CTC grade 2

Primary outcomes:
measure: Tumor response rate of locally advanced head and neck cancer to a paclitaxel-cisplatin combination regimen in a neoadjuvant setting and administered during maximum 3 cycles.
Secondary outcomes:
measure: Toxicity for maximum 3 cycles
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Local Insitution
city: Seoul
country: Korea, Republic of
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05560932: HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 1
Official title: HIV and Alcohol Research Center Focused on Polypharmacy (HARP) Pilot 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV
Alcohol Use
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2022-09-30
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This pilot intervention will consist of a brief intervention for patients with HIV who take 5 or more medications and currently (within the past month) consume alcohol. The focus of this pilot will be on bothersome symptoms and the impact of alcohol use and medications on these symptoms. The rationale is that any alcohol use may interact with medications in serious ways leading to adverse outcomes, including bothersome symptoms.


Eligibility criteria: Inclusion Criteria:

* participants in both Veterans Aging Cohort Study (VACS) and Medications, Alcohol, and Substance use in HIV (MASH) studies
* prescribed 5 or more medications AND who either have a positive PEth value (8+) or a self-reported AUDIT-C value consistent with current alcohol use (score \>0)

Exclusion Criteria:

* Alcohol use disorder (AUD) diagnosis in the past 12 months or who test positive for AUD on the Alcohol Symptom Checklist for moderate or severe AUD (score of 4 or more)

Primary outcomes:
measure: Change in Bothersome Symptoms from baseline using the HIV Symptoms Index
timeFrame: baseline, immediately post-intervention, 30 days post intervention
measure: Change in Phosphatidylethanol (PEth) Levels
timeFrame: baseline and 30 days post intervention
measure: Number of Medications Prescribed Post Intervention
timeFrame: baseline and 30 days post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: West Haven
country: United States
facility: West Haven CT Veterans Administration
state: Connecticut
Study officials:
affiliation: Yale University
name: Amy C Justice, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06920732: Comparative Efficacy of 3L and 2L Integrated Techniques for Gynecologic Cancer-related Lower Extremity Lymphedema: a Retrospective Study
Official title: Comparative Efficacy of 3L and 2L Integrated Techniques for Gynecologic Cancer-related Lower Extremity Lymphedema: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gynecologic Cancer-related Lower Extremity Lymphedema
Lymphedema
Lead sponsor: Zunyi Medical College
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 125
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From January 1st of 2018 to December 31th of 2023, 125 consecutive patients with secondary lower extremity lymphedema who underwent 3L(LVA+VLNT+LS) or 2L(LVA+LS or VLNT+LS) integrated surgical treatment were identified.

Brief summary: The goal of this retrospective study is to evaluate the long-term efficacy of 3L versus 2L integrated techniques in patients with gynecologic cancer-related lower extremity lymphedema (GCR-LEL). The main research question is:

Do 3L integrated techniques provide superior long-term outcomes in reducing lower extremity lymphedema compared to 2L techniques in patients with GCR-LEL?

Medical records of patients who have received either 3L or 2L integrated interventions as part of their routine clinical management for GCR-LEL were reviewed and analyzed to assess treatment outcomes over an extended follow-up period.


Eligibility criteria: Inclusion Criteria:

1. The patients diagnosed with gynecological cancer-related lymphedema by clinical examination are classified by the International Lymphedema Society (ISL) guidelines as Stage II to III.
2. .Aged 18-90 years.

Exclusion Criteria:

1. Lactation, for patients with pregnancy;
2. Serious heart, lung, liver, kidney disease, as well as the history of tumor patients;
3. Disease history is less than 3 months;
4. In patients with mental illness;
5. Immunodeficiency patients.

Primary outcomes:
measure: Change in lower limb volume (mL) measured by circumference-based calculation
timeFrame: Preoperative baseline vs. postoperative follow-up (e.g., 3, 6, 12 and 18 months)
Secondary outcomes:
measure: Cellulitis Infection Rate (episodes/year)
timeFrame: Preoperative baseline vs. postoperative follow-up (e.g., 3, 6, 12 and 18 months)
measure: Change in Lymphoedema Quality of Life (LYMQOL) Score
timeFrame: Preoperative baseline vs. postoperative follow-up (e.g., 3, 6, 12 and 18 months)
measure: Incidence of Surgical Complications
timeFrame: Up to 30 days post-surgery and during follow-up (e.g., 3, 6, 12 and 18 months)
measure: Changes in Lymphoscintigraphy and Ultrasound Findings
timeFrame: Preoperative imaging vs. postoperative imaging at 6, 12 and 18 months
Other outcomes:
Locations:
city: Zunyi
country: China
facility: Department of Burns and Plastic Surgery, Affiliated Hospital of Zunyi Medical University
state: Guizhou
Study officials:
References:
Clinical trial NCT05375032: Acute Effects of Cycling Dual-task in Parkinson´s Disease.
Official title: Acute Effects of Cycling Dual-task on Cognitive and Physical Function in Parkinson´s Disease: a Cross-sectional Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University of Vigo
Sponsor class: OTHER
First posted: 2022-05-16
Enrollment: 44
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Taking into account the process of functional and cognitive evolution that patients with Parkinson's disease experience throughout the pathology, the objective of this study is to evaluate the acute effects of aerobic exercise in forced cycling performed with lower limbs and freecycling of upper limbs combined with cognitive stimuli on attention, exploration skills, and short-term motor skills in people with Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

* Idiopathic Parkinson's disease
* Present stage between I and III on the Hoenh and Yarh scale
* Being able to move autonomously

Exclusion Criteria:

* Moderate-severe cognitive impairment (Mini-mental test \> 24)
* Comorbidity that discourages the practice of physical exercise and that allows performing all scheduled assessments
* Severe visual alterations that prevent the development of the session

Primary outcomes:
measure: Change from baseline Symbol Digit Modalities Test at 30 minutes
timeFrame: Pre and up to 30 minutes.
measure: Mini-Mental State Examination (MMSE)
timeFrame: Pre
Secondary outcomes:
measure: Borg Rated Perceived Exertion Scale
timeFrame: Up to 30 minutes.
measure: Change from baseline Heart Rate at 30 minutes
timeFrame: Pre and up to 30 minutes
Other outcomes:
measure: Active Distance (m)
timeFrame: During the unique session
measure: Passive Distance (m)
timeFrame: During the unique session
measure: Total Work (W)
timeFrame: During the unique session
measure: Active Speed (rpm)
timeFrame: During the unique session
measure: Passive Speed (rpm)
timeFrame: During the unique session
measure: Symmetry (%)
timeFrame: During the unique session
Locations:
city: Pontevedra
country: Spain
facility: University of Vigo
Study officials:
References:
Clinical trial NCT03568032: Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma
Official title: The Clinical Study of Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma Treated by IMRT
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasopharyngeal Carcinoma
Carotid Artery Diseases
Keywords: intima media thickness
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is selected from new patients or post-radiation patients who come to the clinics of radiation oncology.

Brief summary: Radiation-associated carotid vasculopathy is a common late sequelae in patients with head and neck cancer, which correlates with the incidence of stroke. Currently, little is known about the incidence of radiation-associated carotid vasculopahty in the context of intensity-modulated radiation therapy (IMRT).

The aim of this study is to determine whether IMRT will increase the incidence of carotid vasculopathy in patients with nasopharyngeal carcinoma (NPC).


Eligibility criteria: Inclusion Criteria:

* signed inform consent
* age more than 18 years old
* ECOG 0-2
* pathologic diagnosed, non-metastatic NPC
* either untreated or treated by definitive IMRT 3 years ago
* did not receive radiation to the head and neck region prior to the diagnosis of NPC
* if the patient received definitive IMRT 3 years ago because of NPC, he or she did not receive a second course of radiation due to local relapse
* no prior surgery of head and neck

Exclusion Criteria:

* prior history of cardiovascular disease before the diagnosis of NPC
* prior radiation to head and neck before the diagnosis of NPC
* prior surgery of head and neck
* pregnant or lactating women

Primary outcomes:
measure: intima media thickness of carotid artery
timeFrame: This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.
Secondary outcomes:
measure: the incidence of carotid stenosis
timeFrame: This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.
measure: the number of carotid plaques
timeFrame: This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.
measure: total number of Montreal Cognitive Score (range: 0-30)
timeFrame: This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
affiliation: Fudan University
name: Xiayun He, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06894732: To Study the Safety and Efficacy of Disposable Cyclone Ring in Artificial Abortion
Official title: To Study the Safety and Efficacy of Disposable Cyclone Ring in Artificial Abortion
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Induced Abortion
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 332
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the two surgical methods of surgical rotation abortion and surgical negative pressure uterine aspiration with the termination of pregnancy. which one can better protect female fertility; To understand the impact of both surgical approaches on the long-term prognosis of patients.


Eligibility criteria: Inclusion Criteria:

* 1) Age: 20-40 years old, planning to terminate pregnancy; 2) Menopause time≤ 56 days (8 weeks); 3) Ultrasound examination showed early pregnancy in utero, and the average diameter of the fetal sac was 1-3cm; 4) According to the requirements of clinical operation standards, the preoperative examination, laboratory results and surgical indicators are normal 5) The subject was conscious, had good compliance, agreed to participate in the trial, and voluntarily signed the informed consent form

Exclusion Criteria:

* 1) According to the requirements of clinical practice, there are contraindications to induced abortion; 2) The number of previous induced abortions ≥2 times; 3) Diseases affecting uterine cavity morphology such as uterine malformations and uterine fibroids; 4) History of uterine surgery: such as submucosal myomectomy history, mediastinal resection history, uterine adhesion-separation history; 5) Unable to sign the informed consent; 6) Other conditions that the investigator considers inappropriate to participate in this clinical study.

Primary outcomes:
measure: Cervical dilation rate (e.g. %)
timeFrame: 30
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
References:
Clinical trial NCT01012232: Local Anesthetic in Total Knee Arthroplasty (TKA): Volume Versus Concentration
Official title: The Volume-concentration Relationship of Analgesic Efficacy With Intra-capsular Local Anesthetic in Total Knee Arthroplasty: a Randomized, Double-blind, Cross-over Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Analgesic Efficacy
Keywords: total knee arthroplasty
postoperative pain
Lead sponsor: Lundbeck Foundation
Sponsor class: OTHER
First posted: 2009-11-11
Enrollment: 48
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In a randomized, double-blind, cross-over trial, 48 patients scheduled for total knee arthroplasty with placement of an intracapsular catheter will be randomized to receive bolus injection of ropivacaine in high volume/low concentration (20 ml, 5 mg/mL) or low volume/high concentration (10 mL, 10 mg/mL) 6 and 24 hours postoperatively, and pain will be assessed at rest and with mobilization for 2 hours after injections.


Eligibility criteria: Inclusion Criteria:

* Scheduled for total knee arthroplasty
* Able to give informed oral and written consent to participate

Exclusion Criteria:

* Treatment with opioids or steroids, rheumatoid arthritis or other immunological diseases
* History of stroke or any neurological or psychiatric disease potentially influencing pain perception (e.g. depression, diabetic neuropathy etc.)
* Allergies to any of the drugs administered.

Primary outcomes:
measure: postoperative pain
timeFrame: 32 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Lundbeck Centre for fast-track hip and knee arthroplasty
Study officials:
References:
Clinical trial NCT07014332: Comparison of Alignment Efficiency of Steel Vs Elastomeric Ligatures In Lower Anterior Teeth
Official title: Comparison of Alignment Efficiency of Steel Vs Elastomeric Ligatures In Lower Anterior Teeth: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malocclusion of Anterior Teeth
Keywords: Orthodontic treatment
Ligature type
Steel ligature
Elastomeric ligature
Alignment time
Lead sponsor: Khyber College of dentistry
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 180
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To compare the treatment time required by elastomeric ligatures and steel ligatures, in days, to achieve complete alignment of the lower anterior teeth.

Detailed description: Treatment time required to achieve alignment by two ligation methods will help us in future to choose a better method. The two methods study are elastomeric ligature and steel ligature.

Eligibility criteria: Inclusion Criteria:

1. Patients coming for fixed orthodontic treatment requiring premolar extraction in mandibular arch.
2. Age 12-18 years.
3. No adjunct therapeutic intervention involving functional or orthopaedic appliances.
4. Little's Irregularity index score of 7-9mm.

Exclusion Criteria:

1. Patients with systemic conditions and taking medications affecting tooth movement.
2. Lower anterior teeth that are missing, impacted or unerupted, or have fractured crown, restorations, Enamel Defects, Caries.
3. Poor periodontal health

Primary outcomes:
measure: Alignment time to reach little irregularity index of zero
timeFrame: From recruitment to 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Peshawar
country: Pakistan
facility: Khyber College of Dentistry
state: Khyber Pakhtunkhwa
Study officials:
affiliation: Khyber College of dentistry
name: Ahsan Mehmood Shah, Fellowship
role: STUDY_DIRECTOR
References:
Clinical trial NCT01979432: The Cognitive and Cardiovascular Health in the Elderly Study
Official title: The Cognitive and Cardiovascular Health in the Elderly Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cognitive Diseases
Keywords: Alzheimer, cognitive diseases, Ankle-to-brachial index
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 17
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The main objective of this study is to look for the interest forecast of the IPS as infra-clinical cardiovascular marker in the prediction of a change of the cognitive functions (MCI) at the elderly of 70 and more years old without clinical cardiovascular pathology.


Eligibility criteria: Inclusion Criteria:

* free-living community-dwelling men and women aged ≥ 70 years,
* subjects free of clinical CVD related to atherosclerosis
* preserved basic activities of daily living (ADL = 6)
* without cognitive impairment (MMSE≥24)

Exclusion Criteria:

* subjects with clinical history of any of the following CVD diseases : coronary artery disease (angina, myocardial infarction, coronary revascularization), cerebrovascular disease (stroke, TIA, carotid revascularization), clinical peripheral artery disease (claudication, critical limb ischemia)
* subjects with neurodegenerative, locomotor and ophtalmological diseases unable to perform the cognitive tests
* subjects unable to give written informed consent.

Primary outcomes:
measure: Incident "MCI" according to the following criteria
timeFrame: one time point
Secondary outcomes:
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU of Limoges
Study officials:
References:
Clinical trial NCT04158232: Assessment of Regenerative Potential of Mature Permanent Teeth With Necrotic Pulps Using Two Revascularization Protocols. (In Vivo Study)
Official title: Assessment of Regenerative Potential of Mature Permanent Teeth With Necrotic Pulps Using Two Revascularization Protocols. (In Vivo Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Apical Periodontitis
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 20
Sex: ALL
Minimum age (years): 11
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Regenerative endodontic procedures have been used to successfully treat human mature permanent teeth with necrotic pulps and apical periodontitis. Many researchers have begun to apply regenerative endodontic procedures to mature teeth in adult patients. Several clinical case reports have shown complete resolution of signs and symptoms of pulp necrosis in mature teeth, even those with large periapical lesions, as well as signs of pulp canal obliteration. thevaim of this study is To assess the regenerative potential of mature permanent teeth with necrotic pulps with platelet-rich fibrin (PRF) and blood clot using radiographic and clinical methods.


Eligibility criteria: Inclusion Criteria:

* Patients with mature teeth.
* Patients with periapical periodontitis.
* Maxillary anterior teeth only will be involved.
* Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
* Patients who will agree to the consent and will commit to follow up period.

Exclusion Criteria:

* Patients with immature roots.
* Patients with any systemic disease that may affect normal healing.
* Patients with swelling.
* Pregnant females.
* Patients who could/would not participate in a 1 year follow up.
* Patients with fistula.
* Patients with old age.
* Teeth with periodontal involvement.
* Teeth with vertical root fractures.
* Unrestorable teeth.

Primary outcomes:
measure: clinical success
timeFrame: 9 months
measure: radiographic success
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Youssef A, Ali M, ElBolok A, Hassan R. Regenerative endodontic procedures for the treatment of necrotic mature teeth: A preliminary randomized clinical trial. Int Endod J. 2022 Apr;55(4):334-346. doi: 10.1111/iej.13681. Epub 2022 Jan 31.