louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05777005: Promoting Smoking Cessation in Campus
Official title: Promoting Smoking Cessation in Campus Via Smoking Cessation Contest: a Chatbot-based Smoking Cessation Intervention
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Mobile Health
Lead sponsor: Beijing Normal University
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to explore the feasibility, preliminary effectiveness, and implementation outcomes of chatbot-led smoking cessation support in community smokers.


Eligibility criteria: Inclusion Criteria:

1. aged 18 and above, reside in Zhuhai for the next 6 months;
2. smoke at least 1 cigarette or use e-cigarettes daily;
3. Having a smartphone and a WeChat account, being able to use WeChat skillfully.

Exclusion Criteria:

1. Smokers who have communication barrier (either physically or cognitively);
2. Smokers who are currently participating in other SC programmes or services

Primary outcomes:
measure: Participation rate of eligible smokers
timeFrame: Baseline
measure: Biochemical validated quit rate at 6 months follow-up
timeFrame: 6 months follow-up
Secondary outcomes:
measure: Biochemical validated quit rate at 3 months follow-up
timeFrame: 3 months follow-up
measure: Self-reported 7-day point prevalence quit rate
timeFrame: 3 and 6 months follow-up
measure: Smoking reduction rate
timeFrame: 3 and 6 months follow-up
measure: Engagement in chatbot-led group support and/or counselor-led individual support
timeFrame: 3 and 6 months follow-up
Other outcomes:
Locations:
city: Zhuhai
country: China
facility: Beijing Normal University
state: Guangdong
Study officials:
References:
Clinical trial NCT01090505: Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced Gastric Cancer
Official title: Phase 2 Study of S-1 and Oxaliplatin as Neoadjuvant Chemotherapy for Locally Advanced
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2010-03-22
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether S-1 and oxaliplatin as neoadjuvant chemotherapy may improve survival benefit compared with control.


Eligibility criteria: Inclusion Criteria:

1. DISEASE CHARACTERISTICS:

   Histologically confirmed gastric adenocarcinoma Locally advanced disease:Clinical stage T3-4, N0-3, M0 (according to the Japanese gastric cancer classification)
2. Planning to undergo gastric cancer D2 surgery after neoadjuvant chemotherapy
3. Age:20 to 75
4. Performance status:ECOG 0-2
5. Life expectancy:Not specified
6. Hematopoietic:WBC 4,000-12,000/mm\^3；Granulocyte count ≥ 2,000/mm\^3；Platelet count ≥ 100,000/mm\^3；Hemoglobin ≥ 9.0 g/dL;Hepatic:AST and ALT ≤ 100 U/L；Bilirubin ≤ 1.5 mg/dL
7. Adequate organ function
8. Able to swallow oral medication
9. Written informed consent

Exclusion Criteria:

1. Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ
2. Pregnant or breast-feeding women
3. Severe mental disease
4. Systemic administration of corticosteroids, flucytosine, phenytoin or warfarin
5. Other severe complications such as paralytic ileus, intestinal pneumonitis, pulmonary fibrosis, or ischemic heart disease
6. Myocardial infarction within six disease-free months

Primary outcomes:
measure: overall survival
timeFrame: 5 years
Secondary outcomes:
measure: response rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: China PLA General Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT06681805: Prophylactic Mirtazapine and Different Doses of Intrathecal Morphine in Preventing Nausea and Vomiting After Cesarean Section
Official title: Role of Prophylactic Mirtazapine and Different Doses of Intrathecal Morphine in Preventing Nausea and Vomiting After Cesarean Section: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prophylactic
Mirtazapine
Intrathecal
Morphine
Nausea
Vomiting
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2024-11-08
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this work was to evaluate the role of prophylactic mirtazapine and different doses of intrathecal morphine in preventing nausea and vomiting.

Detailed description: It is common practice to provide intrathecal morphine to alleviate postoperative pain because of its powerful and long-lasting analgesic effects. Mirtazapine is a noradrenergic and specific serotonergic antidepressant. It is anxiolytic by its antagonist of the 5HT2 receptor and is strongly sleep-inducing. Its antagonist at 5-hydroxytryptamine subtype 3 (5-HT3) receptor may help to prevent nausea and vomiting

Eligibility criteria: Inclusion Criteria:

* Age 18-40 years.
* American Society of Anesthesiologists (ASA) physical status I-II.
* Scheduled for caesarean section under spinal anesthesia

Exclusion Criteria:

* Known hypersensitivity to mirtazapine.
* Gastrointestinal illness.
* Diabetes mellitus.
* Use of opioids or any medication with known antiemetic properties within 48 hours before surgery.
* Mental disorders.
* Spinal anesthesia contraindications.
* Taking antidepressants or antipsychotic medications.

Primary outcomes:
measure: Incidence of postoperative nausea and vomiting
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Degree of pain
timeFrame: 24 hours postoperatively
measure: Time to first rescue analgesia
timeFrame: 24 hours postoperatively
measure: Total pethidine consumption
timeFrame: 24 hours postoperatively
measure: Incidence of adverse events
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafrelsheikh University
state: Kafrelsheikh
Study officials:
References:
Clinical trial NCT06346405: Central Serous Chorioretinopathy and Micropulse Laser Treatment
Official title: Central Serous Chorioretinopathy and Micropulse Laser Treatment: Evaluation of Morphological and Functional Recovery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Central Serous Chorioretinopathy
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-04-04
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 18 years old, with diagnosis of central serous chorioretinopathy since at least 6 months, undergone Acetazolamide and/or Eplerenone therapy with no improvement after 6 months.

Brief summary: To evaluate choroidal and choriocapillaris changes in patients with central serous chorioretinopathy, undergone sub threshold micropulse laser treatment, following any improvement with conservative therapy with Acetazolamide and/or Eplerenone


Eligibility criteria: Inclusion Criteria:

* Diagnosis of central serous chorioretinopathy (CSC) with no response to conservative therapy, consisted in Acetazolamide and Eplerenone after six months.
* Foveal serous retinal detachment for at least 6 months.
* Minimum age of 18 years old at the screening time
* Reading and comprehension skills of informed consent

Exclusion Criteria:

* Previous retinal treatment for CSC, except for Acetazolamide and Eplerenone
* No diffuse retinal epitheliopathy
* Other concomitant ocular diseases, such as age related macular degeneration, diabetic retinopathy, choroidal neovascularization
* Not controlled glaucoma with eyedrops, or advanced glaucoma
* Myopia or hypermetropia greater than 6 diopters
* Opacities of dioptric media
* Low quality of optical coherence tomography (OCT) and OCT-Angiography scans
* Low quality images of Fluorescein angiography and indocyanine green angiography
* No written consensus signed.

Primary outcomes:
measure: Vessel density changes
timeFrame: 12 and 24 months
Secondary outcomes:
measure: Choroidal thickness
timeFrame: 12 and 24 months
measure: Choroidal thickness and vessel density
timeFrame: 12 and 24 months
measure: Qualitative analysis of retino-choroidal vascularization with identification of vascular pattern
timeFrame: 12 and 24 months
measure: Metamorphopsia
timeFrame: 12 and 24 months
measure: Metamorphopsia and BCVA
timeFrame: 12 and 24 months
measure: Ellipsoid Zone Integrity
timeFrame: 12 and 24 months
measure: Improvement in retinal function
timeFrame: 12 and 24 months
measure: Quality of life (QoL)
timeFrame: 12 and 24 months
measure: Ellipsoid zone and BCVA
timeFrame: 12 and 24 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Agostino Gemelli, IRCCS
state: R
Study officials:
References:
Clinical trial NCT02768597: Comparing The Outcome of Large-Diameter vs Small-Diameter Glenospheres in Primary Reverse Shoulder Arthroplasty
Official title: A Prospective, Randomized Study Comparing The Outcome of Large-Diameter vs Small-Diameter Glenospheres in Primary Reverse Shoulder Arthroplasty Using the ReUnion System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glenohumeral Joint Degeneration
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Stryker Nordic
First posted: 2016-05-11
Enrollment: 113
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will compare the outcome of primary reverse shoulder arthroplasty using the Stryker ReUnion System with implantation of either a large (40 mm) or a small (36 mm) glenosphere with either a +2 mm or a +6 mm offset.


Eligibility criteria: Inclusion Criteria:

* Subjects willing to sign the informed consent
* Male and non-pregnant female subjects ages 50 - 90 at the time of surgery
* Subjects requiring a primary reverse total shoulder arthroplasty
* Subjects with the diagnosis of cuff-tear arthropathy (CTA), massive irreparable rotator cuff tear (MRCT) or osteoarthritis (OA) with marked posterior subluxation or bone loss

Exclusion Criteria:

* Inability to comply with follow-up requirements
* Subjects with inflammatory arthritis
* Subjects with proximal humerus fractures
* Subjects with sequels of trauma
* Subjects that are immunologically compromised
* Subjects with an active or suspected latent infection in or about the shoulder
* Need to add a tendon transfer
* Need for structural humeral bone graft
* Pregnant subjects

Primary outcomes:
measure: Active Forward Elevation of the Shoulder
timeFrame: One year
measure: Active External Rotation of the Shoulder
timeFrame: One year
measure: Shoulder Abduction Strength
timeFrame: one year
measure: Shoulder External Rotation Strength
timeFrame: One year
measure: Shoulder Internal Rotation Strength
timeFrame: One year
Secondary outcomes:
measure: Oxford Shoulder Score (OSS) Questionnaire
timeFrame: 1 year
measure: American Shoulder and Elbow Surgeons (ASES) Questionnaire
timeFrame: One year
measure: Quick DASH (Disabilities of the Arm Shoulder and Hand) Questionnaire
timeFrame: One year
measure: Shoulder Pain
timeFrame: One year
measure: Patient Satisfaction
timeFrame: One year
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mark Morrey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06251297: Feasibility and Benefits of Reflexology in the Prevention of Neuropathy Induced by Oxaliplatin in Colorectal Cancer
Official title: Feasibility and Benefits of Reflexology in the Prevention of Neuropathy Induced by Oxaliplatin in Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Keywords: oxaliplatin
reflexology
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients will receive a 30-minute reflexology session during each Oxaliplatin infusion.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The management of colorectal cancer often requires oxaliplatin-based chemotherapy, either as part of curative treatment plans or exclusively in palliative situations. Oxaliplatin therefore plays a key role in the management of colorectal cancer. In addition to its digestive and hematological toxicity, oxaliplatin frequently induces chronic, often limiting, sensitive peripheral neuropathy.

Only early discontinuation of oxaliplatin can limit the risk of clinically limiting neurotoxicity (grade ≥ 3).

In oncology, managing the side-effects of treatment is an essential objective of supportive care, and is open to a variety of complementary medicines, including reflexology. This technique, derived from traditional Chinese medicine, involves stimulating reflex points on the arch of the foot.

Detailed description: This first monocentric, prospective pilot study is designed to evaluate if the intervention is feasible in routine clinical practice for patients initiating bimonthly oxaliplatin chemotherapy for colorectal cancer. It will also provide initial estimates of the parameters needed to measure efficacy and impact on patient quality of life.

Patients will receive a reflexology session with each cycle of chemotherapy, and will be assessed during all the treatment period.

Eligibility criteria: Inclusion Criteria:

* Age\>18 years treated for colorectal cancer in Digestive Oncology service Rangueil hospital
* Initiation of intravenous oxaliplatin chemotherapy at 85 mg/m² on a bimonthly schedule.
* Ability to understand and answer a self-questionnaire.
* Life expectancy egal or over 12 weeks
* Signed informed consent form

Exclusion Criteria:

* Pre-existing motor and/or sensitive neuropathy.
* Reflexology treatment within the last 6 months.
* Contraindication to reflexology: venous thrombosis, trauma, wound or metastasis of the foot.
* Patient covered by a legal protection scheme.

Primary outcomes:
measure: number of sessions performed
timeFrame: 6 months
Secondary outcomes:
measure: concordance of peripheral neuropathy evaluation
timeFrame: every month until 6 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU de Toulouse
state: CHU de Toulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Nadim FARES, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04780997: The Effect of Virtual Reality Exercises on Balance in Patients With Osteoporosis
Official title: The Effect of Virtual Reality Exercises on Balance in Patients With Osteoporosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoporosis
Lead sponsor: Nigde Omer Halisdemir University
Sponsor class: OTHER
First posted: 2021-03-04
Enrollment: 20
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Osteoporosis is a systemic disease characterized by low bone mass and increased bone fragility and increased fracture likelihood as a result of deterioration of the bone tissue microstructure.One of the important conditions determining the fracture risk in osteoporosis patients is fall. Balance exercises are perform to reduce the risk of falling.Virtual reality games are used in balance studies in many rehabilitation areas. The aim of this study is to investigate the effect of virtual reality exercises on balance.

Detailed description: Osteoporosis is a systemic disease characterized by low bone mass and increased bone fragility and increased fracture likelihood as a result of deterioration of the bone tissue microstructure.One of the important conditions determining the fracture risk in osteoporosis patients is fall. Balance exercises are perform to reduce the risk of falling.Virtual reality games are used in balance studies in many rehabilitation areas. The aim of this study is to investigate the effect of virtual reality exercises on balance patients with osteoporozis.

Eligibility criteria: Inclusion Criteria:

* diagnosed with primary osteoporosis

Exclusion Criteria:

* history of inflammatory rheumatic disease
* history of vestibular and cerebellar disease
* diseases affecting the central and peripheral nervous system (Parkinson's, stroke, ataxia, dementia, multiple sclerosis, peripheral neuropathy

Primary outcomes:
measure: Static balance index
timeFrame: 4th week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Niğde OHÜ
name: Musa Polat
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06194097: Pediatric Chronic Rhinosinusitis in Asthmatic Children
Official title: Management of Pediatric Chronic Rhinosinusitis in Asthmatic Children
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Sinusitis in Children
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2024-01-08
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial
Primary purpose: TREATMENT

Brief summary: The objectives of this study would be to determine the most effective treatment for children with PCRS and asthma who fail medical management.

Detailed description: This prospective, randomized study would involve children age 6-12 with symptoms of both PCRS and asthma. Their symptoms would first be managed medically with standard medical therapy. In the event they fail medical management, patients would then be randomized to two treatment arms, either adenoidectomy alone or adenoidectomy with ESS. CT scan of the sinuses would then be obtained to evaluate the extent of sinus disease and aid in preoperative planning in those patients undergoing ESS. Sinus mucosa thickening seen on CT is also integral in the diagnosis of PCRS, according to consensus statements published by the American Academy of Otolaryngology. At each visit patient's symptoms would be measured with the SN-5, a validated questionnaire for tracking PCRS.

Eligibility criteria: Inclusion Criteria:

* Inclusion Criteria:

Age 6-12 at time of study enrollment. Presence of chronic sinusitis: \>90 days 2 or more symptoms of purulent rhinorrhea, nasal obstruction, facial pressure/pain, or cough with corresponding endoscopic and/or CT findings in a patient 18 years or younger.

Presence of asthma, as documented in the medical record by the patient's pediatrician and/or pulmonologist

Exclusion Criteria:

* Exclusion criteria include previous sinus surgery, previous adenoidectomy, or presence of cystic fibrosis, antrochoanal polyp, immunodeficiency, or fungal infection.

Primary outcomes:
measure: surgical outcome
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: SUNY Upstate Medical Center
state: New York
Study officials:
References:
Clinical trial NCT05315297: Pulsed Electromagnetic Field (PEMF) Therapy in Thumb CMC Arthritis
Official title: Pulsed Electromagnetic Field (PEMF) Therapy in Thumb CMC Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thumb Osteoarthritis
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Long-Term Objective: Determine if high-frequency PEMF therapy reduces pain in patients with thumb carpometacarpal (CMC) joint osteoarthritis (OA).

Study Design and Methods: This will be a randomized controlled pilot study with 60 subjects with CMC OA randomly divided in two groups. Thirty subjects will receive high-frequency PEMF therapy overlying the CMC joint overnight daily for four weeks. The other 30 subjects will receive a sham PEMF therapy device applied to the same joint overnight daily for four weeks. Pain and function questionnaires will be obtained for all patients at enrollment, four weeks, and six weeks.


Eligibility criteria: Inclusion Criteria:

* an existing diagnosis of CMC OA by a hand specialist based on clinically (tenderness to palpation at the CMC joint and/or positive CMC grind test) and/or radiographically identified CMC OA
* reported pain intensity during activities of daily living less than 7 on the Numeric Pain Rating Scale (NPRS)

Exclusion Criteria:

* pregnant
* unable to consent
* with current infection in hand or upper extremity
* have had prior fracture, significant hand injury, tenosynovitis, complex regional pain syndrome, and/or Dupuytren's disease affecting the thumb
* history of surgical or procedural intervention for CMC OA in the hand of study interest
* do not speak English
* have hand or wrist implants
* have heart or brain implants

Primary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 4 weeks
Secondary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: 6 weeks
measure: Patient-Rated Wrist/Hand Evaluation (PRWHE)
timeFrame: 4 and 6 weeks
measure: Single Assessment Numeric Evaluation (SANE)
timeFrame: 4 and 6 weeks
Other outcomes:
Locations:
city: Redwood City
country: United States
facility: Stanford Medicine Outpatient Center
state: California
Study officials:
affiliation: Stanford University
name: Raymond Chou, MD
role: PRINCIPAL_INVESTIGATOR
References: