louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00964314: Traditional Chinese Medicine Five Elements Music Therapy Improving Quality of Life in Patients With Advanced Cancer
Official title: Prospective Study With RCT Designed for Evaluation of TCM Five Elements Music Therapy Improving Quality of Life in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: advanced cancer
TCM five elements music therapy
quality of life (QOL)
Lead sponsor: Ministry of Science and Technology of the People´s Republic of China
Sponsor class: OTHER_GOV
Collaborators: name: M.D. Anderson Cancer Center
First posted: 2009-08-24
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The study objective is to evaluate the effectiveness of Traditional Chinese Medicine (TCM) five elements music therapy improving quality of life for patients with advanced cancer, as well as establishing the standard operating procedures (SOP) for it.

Detailed description: Design: As randomized controlled trial (RCT) with un-blinded design will be done.

Eligibility criteria: Inclusion Criteria:

* Eligible participation will be enrolled based on diagnostic criteria.
* Advanced cancer patient with more than 50 scores of Karnofsky Performance Score (KPS).
* Diagnosis of advanced cancer
* Patients who are willing to be subject with taking part in this research voluntarily.
* No prior experience with TCM music therapy.
* Newly admitted to TCM oncology department for 3 weeks treatment course.

Exclusion Criteria:

* Complicated diagnose or one who don't consistent with inclusion criteria.
* Patients suffering from psychosis or diagnosis, or psychiatric diagnoses (e.g., schizophrenia).
* Suffering from acute organ prostration or other condition of demanding to rescue，inability for accepting music therapy.
* One don't read or fill in diary owing to some causes, such as state of the art or acuity of vision
* One suffering from hearing disturbance
* Accepted TCM five elements music therapy in the past.

Primary outcomes:
measure: Comparison of KPS Qol, and Diary at baseline and endpoint in each group (data for < 70 year old group).
timeFrame: Difference of(pro-post)treatment for KPS,Qol, Diary
measure: Comparison of KPS Qol, and Diary at baseline and endpoint in each group (data for the >70 year old group).
timeFrame: Difference of(pro-post)treatment for KPS,Qol, Diary
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Xi-Yuan Hospital, China Academy of Chinese Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Oncology Department of Xi Yuan hospital
state: HaiDian district
Study officials:
affiliation: Oncology department of Xi Yuan Hospital, China Academy of Chinese Medical Sciences
name: Yang Yu fei, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01900314: Imaging Biomarkers for TMS Treatment of Depression
Official title: Imaging Biomarkers for TMS Treatment of Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Major Depression
Major Depressive Disorder
TMS
rTMS
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Neuronetics
First posted: 2013-07-16
Enrollment: 40
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this research is to learn more about how rTMS works to reduce the symptoms of depression. This information can be used to improve the effectiveness of the treatment. The study will use functional magnetic resonance imaging (fMRI) to examine changes in brain function after treatment with rTMS. fMRI is a safe and painless technique that allows investigators to observe the brain "at work." The investigators will use fMRI to see what regions of the brain become active when you perform a concentration task and how that activation is changed after rTMS.


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of major depressive disorder
* Male and female subjects, ages 22-65
* Have failed at least 1 antidepressant medication at adequate dose and duration
* On stable antidepressant medication regimen for at least 4 weeks prior to TMS therapy

Exclusion Criteria:

* Diagnosed with a psychotic, bipolar, obsessive-compulsive or post-traumatic stress disorder
* Active substance abuse, including alcohol
* Medical and/or neurological condition that could affect your brain function or risk of seizure, including a stroke, epilepsy, or a closed head injury;
* No presence of an implanted device like a pacemaker/neurostimulator or metal in the head or body;
* Pregnant or trying to get pregnant
* Failed to respond to an adequate course of electroconvulsive therapy (ECT)
* Previous treatment with TMS
* Current depressive episode longer than 5 years

Primary outcomes:
measure: Depressive Symptoms at 4 Weeks
timeFrame: 4 weeks after baseline
Secondary outcomes:
measure: Depression Symptoms at 4 Weeks- Secondary
timeFrame: 4 weeks after baseline
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Stephan F Taylor, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taylor SF, Ho SS, Abagis T, Angstadt M, Maixner DF, Welsh RC, Hernandez-Garcia L. Changes in brain connectivity during a sham-controlled, transcranial magnetic stimulation trial for depression. J Affect Disord. 2018 May;232:143-151. doi: 10.1016/j.jad.2018.02.019. Epub 2018 Feb 21.
Clinical trial NCT01359514: Mechanism-based Choice of Therapy for Neuropathic Pain
Official title: Mechanism-based Choice of Therapy for Neuropathic Pain: Can Treatments Success in Neuropathic Post-operative Pain be Coupled to Psychophysical Pain Modulation Profile?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2011-05-24
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mechanism-based choice of therapy for neuropathic pain:

Can treatments success in neuropathic post-operative pain be coupled to psychophysical pain modulation profile?

Detailed description: Neuropathic or idiopathic pain patients will be assessed with the variety of pain tests including the conditioned pain modulation (CPM) and temporal summation (TS). Then, they will be offered on the double-blind design a several weeks treatment with either pregabalin or duloxetine. Patients will be followed-up weekly by phone for their pain relief and will be re-assessed in the lab toward the end of the treatment. The investigators suggest that patients with less-efficient CPM (deficient pain inhibition) will "earn" more pain relief from the treatment with duloxetine, while the patients with the enhanced pain summation will response better to pregabalin.

Eligibility criteria: Inclusion Criteria:

* patients planned for thoracotomy

Exclusion Criteria:

* age below 18 and above 75 years
* patients with psychiatric or cognitive dysfunction precluding use of psychophysics
* those who cannot communicate in Hebrew
* patients with existing thoracic or other current chronic pain

Primary outcomes:
measure: clinical pain
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical center
Study officials:
affiliation: Rambam Health Care Campus
name: David Yarnitsky, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Haifa University
name: Michal Granot, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01247714: Clinical Evaluation of a Specific Enteral Diet for Diabetics
Official title: Clinical Evaluation of a Specific Enteral Diet for Diabetics.A Randomised Cross-Over Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hyperglycemia
Diabetics
Metabolic Syndrome
Keywords: T-Diet plus Diabet NP
Diabetic
Enteral Nutrition
Glycaemic response
Metabolic Syndrome
Insulin resistance
Lipidic profile
Lead sponsor: Vegenat, S.A.
Sponsor class: INDUSTRY
First posted: 2010-11-24
Enrollment: 43
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The hypothesis of the proposed trials is that the regular intake of a specific diet designed for enteral nutrition of type 2 diabetic patients results into a better nutritional status. Thus, the aim of the study is to scientifically evaluate the healthy effects of the administration of an enteral complete diet for diabetic patients (T-Diet plus Diabet).

Detailed description: This new complete diet has been carefully formulated, and incorporates functional ingredients based on:

1. A good gastrointestinal and metabolic tolerance of the product.
2. Beneficial outcomes in the nutritional status.
3. A good control of the glycaemic response and the lipidic profile, allowing an improvement of metabolic syndrome and insulin resistance indicators and hunger-satiety regulation.

The experimental enteral product is a complete diet that includes, as carbohydrates, high-molecular maltodextrin, resistant maltodextrin, fructooligosaccharides and cellulose, and does not contain added fructose. Indeed, this product contains eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

Eligibility criteria: Inclusion Criteria:

* Diabetic Subjects older than 55 years.
* Male or female
* Requirement of total enteral nutrition (TEN) during at least 3 months.
* Under medical supervision.
* Voluntary informed consent for participation.

Exclusion Criteria:

* Unstable clinical situation
* Fatal illness
* Patients treated with lipidic drugs
* Refusal to participate in the study or being enrolled in other clinical trials.
* Social or humanitarian reason

Primary outcomes:
measure: Nutritional status and Glycaemia
timeFrame: 9 months
Secondary outcomes:
measure: Biochemicals parameters measure
timeFrame: 9 months
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Department of Biochemistry and Molecular Biology II. University of Granada
Study officials:
affiliation: Departament of Biochemistry and Molecular Biology II. University of Granada
name: Ángel Gil, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04804514: Evaluation of the Safety and Tolerability of KH001 in Dentin Hypersensitivity Patients
Official title: Phase 1/2a Study of KH001 in Dentin Hypersensitivity Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dentin Sensitivity
Keywords: Dentin regeneration
Hypersensitivity
Sensitivity
Tooth sensitivity
Lead sponsor: HysensBio Co., Ltd
Sponsor class: INDUSTRY
First posted: 2021-03-18
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a phase 1/2a study in dentin hypersensitivity patients to assess the safety, tolerability, efficacy and pharmacokinetics of single and multiple doses of KH001.


Eligibility criteria: \[Inclusion criteria\]

1. Subjects must be fully aware of the purpose and the content of the study, and the characteristics of the Investigational Product to sign written consent of their free will to take part in the study;
2. Subjects having at least 20 natural teeth and two teeth that could be assessed
3. Subjects is diagnosed with dentin hypersensitivity, has experienced dental symptoms of two or more teeth

\[Exclusion criteria\]

1. Subjects is allergic to the active substance or other excipients used in the Investigational Product
2. Subjects has any history of clinically significant allergy, such as drug allergy, asthma, eczema, or anaphylaxis
3. Subjects has any disease related to dentin hypersensitivity
4. Subjects taking anti-inflammatory analgesic drugs

Primary outcomes:
measure: Number of subjects with adverse events(AEs)
timeFrame: up to 22 days and 36 days
Secondary outcomes:
measure: Change from baseline in VAS(Visual Analogue Score).
timeFrame: up to 22 days and 36 days
measure: Maximum plasma concentration (Cmax) of KH001 single and multiple ascending dose.
timeFrame: 0~24 hours
measure: Area under the concentration-time curve (AUC) of KH001 single and multiple ascending dose
timeFrame: 0~24 hours
measure: Time to reach maximum concentration (Tmax) of KH001 single and multiple ascending dose
timeFrame: 0~24 hours
measure: Elimination half life (t½) of KH001 single and multiple ascending dose
timeFrame: 0~24 hours
measure: Estimate of apparent clearance (CL/F) of KH001 single and multiple ascending dose
timeFrame: 0~24 hours
measure: Change from Baseline in Evaporative Air Sensitivity and Tactile Threshold
timeFrame: up to 22 days and 36 days
measure: Change from baseline in Dentine Hypersensitivity Experience Questionnaire
timeFrame: up to 22 days and 36 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Dental Hospital
Study officials:
References:
Clinical trial NCT00787514: FR in Stored Plasma
Official title: Measurement of the Folate Receptor in Stored Plasma From Patients With Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Keywords: ovarian cancer, folate receptor, plasma
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Institute of Cancer Research, United Kingdom
First posted: 2008-11-07
Enrollment: 27
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Sampling method: PROBABILITY_SAMPLE
Study population: In the first stage of the study 13 samples will be analysed. If thee is one or more positive results the study will progress to the 2nd state to include 14 more samples.

Brief summary: The folate receptor (FR) is a cell over expressed on the surface of certain cancers, this occurs most frequently in ovarian cancers. Some normal tissues also express the FR, however in these normal tissues, the FR is usually located on the tissue surface that is inaccessible to circulating drugs. As such, drugs which target the FR may potentially be used to target cancers which overexpress the FR while reducing toxicity to normal tissues. Therefore the ability to measure FR levels from different cancer types may help to select patients who are most likely to benefit from treatment with FR targeted therapies. Once such drug BGC945 is currently being tested in preclinical study at the Institute of Cancer Research

Detailed description: FR may be released from the cancer cells in the blood. We have developed a method in the laboratory which has been able to measure the FR obtained from cancer cells in culture which has been added into blood. We would like to study if this method is able to measure the FR in stored plasma samples obtained from patients with ovarian cancer, so that it may be developed as a method for selecting patients for FR-target treatments such as BGC 945.

Eligibility criteria: Inclusion Criteria:

* Patients with ovarian cancer who have given informed consent to have blood collected for the plasma bank in the 'Pharmacogenetics and proteomics studies in patients receiving novel anticaner agents' study.

Exclusion Criteria:

* Patients who have withdrawn consent form their blood stored within the 'Pharmacogenetics and proteomics studies in patients receiving novel anticancer agents' study to be used for research.

Primary outcomes:
measure: To measure the levels of soluble folate receptor in stored plasma obtained from patients with ovarian cancer
Secondary outcomes:
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
References:
Clinical trial NCT01451814: Development of Positive Psychotherapy for Smoking Cessation
Official title: Development of Positive Psychotherapy for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Smoking
Keywords: smoking cessation
Lead sponsor: Brown University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-10-14
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to test a manualized adaptation of positive psychotherapy (PPT) for smoking cessation (PPT-S). The investigators will conduct a preliminary randomized clinical trial (N = 80) to examine the feasibility, acceptability, and efficacy of PPT-S over 26 weeks of follow up in comparison to a standard smoking cessation treatment. Both treatments will be delivered in individual 6 sessions over 6 weeks, and will include provision of transdermal nicotine patch. The effect size estimates from this Stage 1b research will provide the foundation for a future application to conduct a large-scale, Stage II, randomized clinical trial.


Eligibility criteria: Inclusion Criteria:

* smoke at least 5 cigarettes per day for longer than one year with no other ongoing tobacco product use
* willing to use the transdermal nicotine patch
* report at least a 5 on a 0 to 10 scale rating the importance of quitting smoking.

Exclusion Criteria:

* are currently experiencing psychotic symptoms, affective disorder (major depression, dysthymia, or mania) or substance use disorder (other than nicotine dependence)
* taking prescribed psychotropic medication or receiving other forms of psychotherapy
* concomitantly using other pharmacotherapies for smoking cessation
* have any contraindications for use of the transdermal nicotine patch.

Primary outcomes:
measure: 7-day Point Prevalence Smoking Abstinence at 8 Weeks
timeFrame: 8 weeks
measure: 7-day Point Prevalence Smoking Abstinence at 16 Weeks
timeFrame: 16 Weeks
measure: 7-day Point Prevalence Smoking Abstinence at 26 Weeks
timeFrame: 26 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Center for Alcohol and Addiction Studies, Brown University
state: Rhode Island
Study officials:
References:
citation: Kahler CW, Spillane NS, Day AM, Cioe PA, Parks A, Leventhal AM, Brown RA. Positive Psychotherapy for Smoking Cessation: A Pilot Randomized Controlled Trial. Nicotine Tob Res. 2015 Nov;17(11):1385-92. doi: 10.1093/ntr/ntv011. Epub 2015 Feb 2.
Clinical trial NCT00574314: Women's Health Research Registry
Official title: Women's Health Research Registry
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Healthy
Keywords: women
Registry
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2007-12-17
Enrollment: 839
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult English-speaking women

Brief summary: Women have been disproportionately underrepresented in clinical research. Few of the many drugs approved by the FDA have been adequately tested in women. Most common health conditions experienced by both women and men are managed by treatments that have been developed and tested most in men.

A new barrier to enrolling women in clinical trials is in effect: HIPAA (the Health Insurance Portability and Accountability Act). The positive benefit of HIPAA-protecting a person's health information from abuse-is laudable, but it comes at a cost: it will deny investigators the benefit of access to chart (medical record) review in order to gather data to answer clinical questions. In the past, investigators were allowed access to patient's charts because the hospital consent form included a clause indicating that the patient's information may be used for research.

The investigators propose to overcome this crisis and challenge with a proven method of identifying individuals who would be willing to consider participating in a clinical trial: The Women's Guild Health Research Registry. In keeping with the focus of the Women's Health Program, we would propose to enroll only women. The registry will allow qualified investigators to identify potential study participants. This idea has been effective at improving the quantity and quality of women able and willing to participate in trials.

The investigators will also allow other approved sites to utilize the Registry via the approved procedure of submitting an IRB approved protocol which will be reviewed by our Internal Review Committee. This protocol's inclusion/exclusion criteria will be used to query the database for eligible participants. The participants will be contacted by the Registry staff to ascertain their interest in this research protocol and their agreement to release their contact data to the investigator will be obtained.

Investigators will be charged at the time they approach the registry for assistance. The charge is intended to cover the cost of maintaining the registry now that initial funding has been exhausted.

Detailed description: See Brief Summary above

Eligibility criteria: Inclusion Criteria:

* Adult women
* English speaking

Exclusion Criteria:

* We do not include children.
* We do not include non-English speaking subjects at this time.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Women's Heart Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: C. Noel Bairey Merz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04547114: Breath Analysis for SARS-CoV-2 in Infected and Healthy Subjects
Official title: Breath Analysis for SARS-CoV-2 in Infected and Healthy Subjects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV-2 Infection
Lead sponsor: Klinikum Bayreuth GmbH
Sponsor class: INDUSTRY
First posted: 2020-09-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult subjects of all genders and ages

Brief summary: Recently published studies could demonstrate that detection of specific biomarkers in breath could be applied for the diagnosis of SARS-CoV-2.

Detailed description: In this study we want to address the sensitivity and specificity of breath analysis by MCC-IMS in the context of SARS-CoV-2 detection from PCR- proven infected and non-infected subjects.

Therefore nasal breath will be aspirated for 10 seconds during normal respiration by a foam cuffed oxygen catheter connected via a 0.22μm filter and a line into the MCC-IMS and directly analyzed without any pre-analytic procedures.

The during the proof-of-concept study derived significant peaks for volatile organic compounds will be used for discrimination in a point-of-care approach.

Eligibility criteria: Inclusion Criteria:

hospital admission staff members

Exclusion Criteria:

too sick to comply with study procedures

Primary outcomes:
measure: correct classification of SARS-CoV-2 infected and not infected subjects
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bayreuth
country: Germany
facility: Klinikum Bayreuth/ Bayreuth General Hospital
Study officials:
References: