louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04461730: Role of Basal Ganglia and Thalamus in Perceptual Consciousness and Metacognition
Official title: Role of Basal Ganglia and Thalamus in Perceptual Consciousness and Metacognition
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Parkinson Disease
OCD
Dystonia
Keywords: metacognition
consciousness
deep brain stimulation
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pathologies included will be Parkinson's disease (PD), essential tremor, dystonia, and obsessive compulsive disorder (OCD).

Brief summary: The term perceptual awareness refers to subjective experience... or the phenomenology associated with the processing of a sensory stimulus. The term metacognition refers to our ability of introspection, knowledge and control of our own cognitive processes. The objective of this research is to establish the contribution of the basal ganglia and thalamus to the perceptual awareness and meta-cognition, using deep brain stimulation coupled with electroencephalography.


Eligibility criteria: Inclusion Criteria:

* Major patient in need of brain stimulation therapy for motor disorders (Parkinson's disease, tremor, dystonia) or psychiatric disorders (OCD).
* Outpatient or inpatient follow-up
* Fluent in French and able to understand the study procedures
* informed consent
* Patient affiliated to social security
* Written agreement to participate in the patient's study
* Intellectual abilities compatible with the performance of cognitive or motor tasks

Exclusion Criteria:

* Persons referred to in Articles L1121-5 to L1121-8 of the CSP (pregnant women, parturient women, mothers, etc.) who is breastfeeding, person deprived of liberty by judicial or administrative decision, person subject to a legal protection measure
* Patients in whom transient cessation of stimulation is not tolerated
* Subject in period of exclusion from another study
* Subject cannot be contacted in case of emergency
* Subject under administrative or judicial supervision

Primary outcomes:
measure: Behavioral effect of DBS on confidence
timeFrame: by fall 2024
Secondary outcomes:
measure: Effect of DBS on EEG markers of confidence
timeFrame: by fall 2024
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Grenoble
name: ELENA MORO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06199830: A Case-control Study on the Differentiation Between Cough Variant Asthma and Chronic Cough
Official title: A Case-control Study on the Differentiation Between Cough Variant Asthma and Chronic Cough
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Keywords: small airway dysfunction
cough variant asthma
Chronic cough
Lead sponsor: The First Affiliated Hospital of Zhejiang Chinese Medical University
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 645
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We retrospectively collected information from patients with CC who underwent pulmonary tests at the First Affiliated Hospital of Zhejiang Chinese Medical University from January 2019 to December 2019.

Brief summary: this study aimed to compare characters in pulmonary function of patients with cough variant asthma and chronic cough and establish a diagnostic model.

Detailed description: the investigators retrospectively collected information from patients with chronic cough who underwent pulmonary tests at the First Affiliated Hospital of Zhejiang Chinese Medical University from January 2019 to December 2019. Data of external test were also from the First Affiliated Hospital of Zhejiang Chinese Medical University, and time period was from January 2023 to April 2023.Pulmonary function test and methacholine challenge test was performed by professional technicians. Characters between patients with cough variant asthma and chronic cough were compared to establish a diagnostic model.

Eligibility criteria: Inclusion Criteria:

* (1) age from 18 years old to 65 years old; (2) clinical diagnosis of CVA and CC .

Exclusion Criteria:

* Exclusion criteria for CVA were: a history of COPD, bronchiectasis, bronchitis, cystic fibrosisor pneumonia, interstitial lung disease, pulmonary tuberculosis, lung cancer; cough caused by drugs or treatments; patients with upper airway cough syndromes (UACS) and gastroesophageal reflux-related cough (GERC) or other apparent causes of cough; patients who used corticosteroid (ICS) in the previous four weeks; Exclusion criteria for CC were: a history of variable airway limitation.

Primary outcomes:
measure: positive bronchial provocation test
timeFrame: up to 1 week
Secondary outcomes:
measure: small airway dysfuction
timeFrame: up to 1 week
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang Chinese Medical University
Study officials:
affiliation: The First Affiliated Hospital of Zhejiang Chinese Medical University
name: Junchao Yang, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00538330: Post Operative Adjuvant Chemotherapy Followed by Adjuvant Tamoxifen vs Nil for Patients With Operable Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: King Faisal Specialist Hospital & Research Center
Sponsor class: OTHER
First posted: 2007-10-02
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Post operative adjuvant chemotherapy followed by adjuvant Tamoxifen vs nil for patients with operable breast cancer


Eligibility criteria: Inclusion Criteria:

* Patients with operable breast cancer

Primary outcomes:
measure: safety
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: KFSH&RC, Riyadh
name: Adnan Ezzat, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03189030: Study of Personalized Immunotherapy in Adults With Metastatic Colorectal Cancer
Official title: A Phase 1 Safety and Tolerability Study of Personalized Live, Attenuated, Double-Deleted Listeria Monocytogenes (pLADD) Immunotherapy in Adults With Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Colorectal Neoplasms
Keywords: metastatic
microsatellite stable (MSS)
Lead sponsor: Aduro Biotech, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hanlee P. Ji, MD
First posted: 2017-06-16
Enrollment: 28
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: This study will evaluate the safety and tolerability of a personalized live, attenuated, double-deleted Listeria monocytogenes (pLADD) treatment in adults with metastatic colorectal cancer.

Detailed description: This single arm study is designed to evaluate the safety and tolerability of a personalized treatment in adults with metastatic colorectal cancer by first analyzing the expression of tumor-associated antigens and then treating the patients with a personalized live, attenuated, double-deleted Listeria monocytogenes (pLADD)-based immunotherapy. pLADD is based on the attenuated form of Listeria monocytogenes that has been genetically modified to reduce its ability to cause disease, while maintaining its ability to stimulate a potent immune response. pLADD is manufactured using patient-specific antigens and is therefore individualized to each patient.

Eligibility criteria: Inclusion Criteria:

* metastatic colorectal cancer (mCRC) that is microsatellite stable (MSS)
* able to provide adequate tumor tissue from at least 1 accessible tumor site
* completed or have developed intolerance to a course of oxaliplatin- or irinotecan-based frontline therapy at Screening
* on maintenance standard-of-care chemotherapies or on treatment holiday
* Eastern Cooperative Oncology Group (ECOG) 0 or 1
* adequate organ function
* progression of disease at the time of Enrollment

Exclusion Criteria:

* BRAF V600E mutation
* known allergy to both penicillin and sulfa drugs
* implanted devices that cannot be easily removed
* immunodeficiency, immune compromised state or receiving immunosuppressive therapy

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
timeFrame: Through study completion, an average of 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope National Medical Center
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Sacramento
country: United States
facility: University of California Davis Comprehensive Cancer Center
state: California
city: Stanford
country: United States
facility: Stanford
state: California
city: Dallas
country: United States
facility: Mary Crowley Cancer Research - Medical City
state: Texas
Study officials:
References:
Clinical trial NCT02474030: Relationship Between Electrical Pain Tolerance Threshold of Alveolar Ridge and Individual Attributes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intraoral Pain Threshold
Lead sponsor: Nihon University
Sponsor class: OTHER
First posted: 2015-06-17
Enrollment: 150
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Volunteers participants studying or workung at the Nihon University School of Dentistry at Matsudo took part in the study.

Brief summary: This study was conducted with an aim to know how individual attributes associated to intraoral Pain Tolerance Threshold. The hypotheses were that the Pain Tolerance Threshold associated to age, sex, prosthodontic oral condition evaluated by the Eichner Index, and psychological state evaluated by the Profile of Mood States.


Eligibility criteria: Inclusion Criteria:

* not pacemaker wearers

Exclusion Criteria:

* general health problems that could affect the measurement of nerve activity a lack of understanding of written or spoken Japanese

Primary outcomes:
measure: pain threshold
timeFrame: 20minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Matsudo
country: Japan
facility: Nihon University School of Dentistry at Matsudo
state: Tiba
Study officials:
References:
Clinical trial NCT06970730: Accuracy of Virtual Surgical Planning and Patient Specific Implants in Craniomaxillofacial Reconstruction
Official title: Evaluation of Accuracy of Virtual Surgical Planning and Patient Specific Implants in Craniomaxillofacial Reconstruction (Clinical Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Craniofacial Surgery
Virtual Surgical Planning
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 15
Sex: ALL
Minimum age (years): 10
Maximum age (years): 47
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The sample will consist of 10 patients who will need reconstruction of craniomaxillofacial deformities and defects. The patients will be operated in the Maxillofacial and Plastic Surgery Department, Faculty of Dentistry, Alexandria University, Egypt. All patients will be assessed clinically and radiographically using computed tomography (CT) then virtual surgical planning and custom made patient specific implant will be manufactured. Post-operative clinical evaluation will be done and radiographic evaluation of all patients will be done by CT scan

Detailed description: The primary outcome of the study is to evaluate the accuracy of virtual surgical planning and patient specific implants in craniomaxillofacial reconstruction based on radiographic measurements to calculate the angulation deviations of anatomic landmarks between the pre-operative virtual plan and the post-operative actual surgical outcome.

The secondary outcome is long term follow up of the patients clinically and radiographically regarding aesthetics, quality of life and post-operative complications.

Eligibility criteria: Inclusion Criteria:

* Reconstruction of craniofacial, midface, and mandibular bony defects and deformities secondary to:
* Trauma.
* Tumor resection (either by immediate or delayed reconstruction).
* Complex congenital and dentofacial deformities.

Exclusion Criteria:

* Patients with special needs.
* Medically compromised patients who are not fit for surgery.
* Irradiated patients.

Primary outcomes:
measure: Distance deviation
timeFrame: Immediate post operative
measure: Angular deviation
timeFrame: Immediate post operative
Secondary outcomes:
measure: Change in post operative aesthetic results of surgery
timeFrame: 1 week, 4 weeks, 8 weeks, and 6 months
measure: change in Quality of Life (QOL)
timeFrame: 1 week, 4 weeks, 8 weeks, and 6 months
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
state: Azarita
Study officials:
References:
Clinical trial NCT01822730: A Comparison of Paliperidone and Risperidone for Treatment of Patirnts With Methamphetamine-Associated Psychosis
Official title: A Multiple-Center, Randomized, Double-Blind Study of Comparison of Paliperidone and Risperidone for Treatment of Patirnts With Methamphetamine-Associated Psychosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Methamphetamine Dependence
Keywords: Methamphetamine-Associated Psychosis
Aripiprazole
Risperidone
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2013-04-02
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Methamphetamine-associated psychosis (MAP) has been considered a pharmacological or environmental pathogen model of schizophrenia (SCZ) due in part to similarities in clinical presentation (i.e. paranoia, hallucinations, disorganized speech, and negative symptoms), response to treatment (e.g.neuroleptics),and pathologic mechanisms (e.g. central dopaminergic neurotransmission) of both conditions. Both paliperidone and risperidone are second generation antipsychotics，but have same pharmacological effects of antipsychotic treatment and paliperidone may have more efficacy and safty.This study was designed to examine the acute efficacy, safety, and tolerability of paliperidone and risperidone for patients with MAP.

Detailed description: Methods:A Multiple-Center, Randomized, Double-Blind.

Eligibility criteria: Inclusion Criteria:

1. Patients,Diagnostic and Statistical Manual of Mental Disorders 4thed. (DSM-IV) criteria for Methamphetamine-Associated Psychosis.
2. Must sign a Information consent form.
3. Required to provide detailed address and phone number

Exclusion Criteria:

1. Serious organic disease.
2. Suicide ideation or hurt others.
3. Taking antipsychotic within two weeks before.
4. drug allergy to Risperidone or paliperidone.
5. pregnancy and breastfeeding women.

Primary outcomes:
measure: The severity of psychosis
timeFrame: up to 4 weeks. participants will be followed for the duration of hospital stay
Secondary outcomes:
measure: Clinical general status
timeFrame: up to 4 weeks. participants will be followed for the duration of hospital stay
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central University
state: Hunan
Study officials:
affiliation: Central South University
name: Wei Hao, MD., Ph.D.
role: STUDY_DIRECTOR
References:
citation: Wang G, Ding F, Chawarski MC, Hao W, Liu X, Deng Q, Ouyang X. Randomized Controlled Trial of Paliperidone Extended Release Versus Risperidone for the Treatment of Methamphetamine-Associated Psychosis in Chinese Patients. Front Psychiatry. 2020 Apr 1;11:237. doi: 10.3389/fpsyt.2020.00237. eCollection 2020.
Clinical trial NCT01801930: A Phase 1 Study of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer
Official title: A Phase 1 Study of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer Who Are Refractory or Intolerant to Standard Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Colorectal Cancer
Keywords: OCV-C02
Colorectal Cancer
Antigen specific cancer immunotherapeutic
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-03-01
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the safety and tolerability of OCV-C02 in Patients With Advanced or Relapsed Colorectal Cancer Who Are Refractory or Intolerant to Standard Chemotherapy

Detailed description: The incidence of dose limiting toxicity (DLT) will be evaluated in cohorts of six patients by starting OCV-C02 administration at dose level 1 (OCV-103 and OCV-104 at 0.3 mg each), increasing the dose to dose level 2 (at 1 mg each), level 3 (at 3 mg each), and then up to dose level 4 (at 6 mg each). Once-weekly administration will be repeated four times in each treatment cycle, and the incidence of DLT from Day 1 to Day 29 will be evaluated.

At the end of Cycle 1, patients who wish to continue OCV-C02 treatment and have provided their written consent will be permitted to continue participation in the trial using the same dosing schedule for each subsequent cycle as that for Cycle 1.

Eligibility criteria: Inclusion Criteria:

* Patients who have human leukocyte antigen (HLA)-A\*24:02
* Patients who have histologically-confirmed colorectal cancer (adenocarcinoma)
* Patients with advanced or relapsed colorectal cancer who are refractory or intolerant to standard chemotherapy
* Patients with an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1 at the time of enrollment in the trial.

Exclusion Criteria:

* Patients who are HIV antibody test positive
* Patients with an active infection
* Patients who have or are suspected to have CNS metastasis of colon cancer (such as metastatis of the brain)

Primary outcomes:
measure: Dose Limiting Toxicity (DLT)
timeFrame: Day 29
Secondary outcomes:
measure: Number of Subjects With CTCAE Grade 3 or Higher TEAEs
timeFrame: From the start of the study drug administration until the completion of the post-treatment observation (28 days after the last administration)
measure: Tumor Response Rate in Cycle 1
timeFrame: Day 29
Other outcomes:
Locations:
city: Nagoya
country: Japan
city: Sunto-gun
country: Japan
city: Tokyo
country: Japan
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Junichi Hashimoto, PhD
role: STUDY_DIRECTOR
References:
citation: Taniguchi H, Iwasa S, Yamazaki K, Yoshino T, Kiryu C, Naka Y, Liew EL, Sakata Y. Phase 1 study of OCV-C02, a peptide vaccine consisting of two peptide epitopes for refractory metastatic colorectal cancer. Cancer Sci. 2017 May;108(5):1013-1021. doi: 10.1111/cas.13227. Epub 2017 May 11.
Clinical trial NCT01885130: Patch Test Skin Irritation/Sensitization of Cetaphil Daily Advance Ultra Hydration Lotion
Official title: 100 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Occlusive Patch)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Determine Sensitivity of Skin to Cetaphil Daily Advance Ultra Hydrating Lotion
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2013-06-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Determine if Cetaphil Daily Advance Ultra Hydrating Lotion proves to be a contact sensitizer or irritant in certain individuals.


Eligibility criteria: Inclusion Criteria:

* Not currently under a doctor's care
* Free of dermatological or systemic disorder which would interfere with the results
* Free of any acute or chronic disease
* Will complete a preliminary medical history form and are in general good health
* Can read, understand, and sign informed consent

Exclusion Criteria:

* Under 18 years old
* Currently under doctor's care
* currently taking any medication
* History of acute or chronic disease
* Diagnosed with chronic skin allergies
* Pregnant or lactating

Primary outcomes:
measure: area of erythema and edema is measured
timeFrame: 3 consecutive weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AMA Laboratories
name: Mayya Tastene, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00978848: Non-Invasive Sexually Transmitted Disease Testing in Women Seeking Emergency Contraception or Urine Pregnancy Testing
Official title: Non-Invasive Sexually Transmitted Disease Testing in Women Seeking Emergency Contraception or Urine Pregnancy Testing: Meeting the Needs of an At-Risk Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trichomonas Vaginitis
Chlamydia Trachomatis
Neisseria Gonorrhoeae Infection
Keywords: trichomonas
chlamydia
gonorrhea
emergency contraception
emergency contraception use
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Gen-Probe, Incorporated
First posted: 2009-09-17
Enrollment: 305
Sex: FEMALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females at least age 15 at time of enrollment who are presenting at Magee-Womens Hospital for emergency contraception or urine pregnancy testing

Brief summary: The purpose of this study is to determine the prevalence and treatment rates of T. vaginalis, C. trachomatis, and N. gonorrhoeae in women seeking emergency contraception or urine pregnancy testing in the Magee-Womens Hospital outpatient clinic using a non-invasive urine STD test.

Detailed description: This study has three primary objectives: 1) to determine the prevalence of T. vaginalis, C. trachomatis, and N. gonorrhoeae in women seeking emergency contraception or urine pregnancy testing - a population likely at increased risk of acquiring STDs; 2) to determine the rate of successful treatment in women diagnosed with STDs in this venue.

Eligibility criteria: Inclusion Criteria:

* Females at least age 15 at time of enrollment who are presenting at Magee-Womens Hospital for emergency contraception or urine pregnancy testing.
* Ability to provide written informed consent.

Exclusion Criteria:

* Diagnosis and/or treatment for an STD within 4 weeks of enrollment in the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Magee-Womens Hospital of UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Harold C Wiesenfeld, MD, CM
role: PRINCIPAL_INVESTIGATOR
References: