louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05390593: Treatment for Major Depressive Disorder With Intermittent Theta-burst Stimulation
Official title: Treatment for Major Depressive Disorder With Intermittent Theta-burst Stimulation: a Three-track Approach in Affective Computing, Randomized Controlled Trial, and Meta-analysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depressive Disorder, Treatment-Resistant
Keywords: Repetitive transcranial magnetic stimulation
Mood Disorders
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-05-25
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main purpose of this study is to investigate the two different intermittent Theta Burst (iTBS) repetitive transcranial magnetic stimulation (rTMS), its effectiveness in alleviating depressive symptoms. All patients are randomized to two different iTBS groups.


Eligibility criteria: Inclusion Criteria:

1. The diagnosis of major depressive disorder according to DSM-5
2. Total HAM-D17 score of greater than or equal to 18 and Item 3 score less than 4 at screening visit. CGI-S score less than 4.
3. Before treatment, patient have to stop antidepressant for at least 1 weeks.
4. Capable and willing to provide informed consent.

Exclusion Criteria:

1. Have a concomitant major, unstable medical or neurologic illness :

   * Psychiatric disorder: Schizoprenia, Bipolar disorder, Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, substance use disorder.
   * Severe brian disease: Brain tumor, encephalitis, brian injury.
2. Intracranial implant and other ferromagnetic materials close to the head.
3. History of Seizures.
4. Cardiac pacemaker.
5. Pregnancy.

Primary outcomes:
measure: Change in 17-item Hamilton Depression Rating Scale
timeFrame: Baseline, Week 1, Week 2, Week 4
measure: Change in Montgomery-Asberg Depression Rating Scale
timeFrame: Baseline, Week 1, Week 2, Week 4
measure: Change in Beck Anxiety Inventory
timeFrame: Baseline, Week 1, Week 2, Week 4
Secondary outcomes:
measure: Response rate after 2-week treatment at the end of iTBS (HDRD-17 )
timeFrame: Baseline, Week 1, Week 2, Week 4
measure: Response rate after 2-week treatment at the end of iTBS (MADRS)
timeFrame: Baseline, Week 1, Week 2, Week 4
measure: Changes in Clinical Global Index Severity
timeFrame: Baseline, Week 1, Week 2, Week 4
measure: Changes in Heart Rate Variability (HRV) band
timeFrame: Baseline, Week 1, Day 3, Week 2, Week 4
measure: Changes in EEG band
timeFrame: Baseline, Week 1, Day 3, Week 2, Week 4
measure: Change in BDNF
timeFrame: Baseline, Week 2
measure: Change in TSH
timeFrame: Baseline, Week 2
measure: Change in T3
timeFrame: Baseline, Week 2
measure: Change in T4
timeFrame: Baseline, Week 2
measure: Change in cortisol
timeFrame: Baseline, Week 2
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: ChangGungMH
Study officials:
References:
Clinical trial NCT01842893: Efficacy and Safety of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer
Official title: Randomized, Placebo-controlled Study of Fentanyl ETHYPHARM for Breakthrough Pain in Opioid-treated Patients With Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Breakthrough Pain
Cancer
Keywords: fentanyl
breakthrough pain
opioid treated cancer patients
Lead sponsor: Ethypharm
Sponsor class: INDUSTRY
First posted: 2013-04-30
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the clinical effectiveness of Fentanyl ETHYPHARM when used to relieve breakthrough pain (BTP) in opioid-treated cancer patients.


Eligibility criteria: Inclusion criteria:

1. Written informed consent
2. Malignant solid tumor or a hematological malignancy causing cancer-related pain
3. Background opioid treatment at a stable dose for at least a week
4. One to four episodes of breakthrough pain per day

Main exclusion criteria:

1. Hypersensitivity to fentanyl or to any of the excipients
2. Intrathecal opioids
3. Recent history of substance abuse
4. Recent or planned therapy that would alter pain
5. Moderate or severe hepatic or renal disease

Primary outcomes:
measure: Summed Pain Intensity Difference at 30 minutes (SPID30).
timeFrame: 30 minutes post dose
Secondary outcomes:
measure: SPID at 3, 6, 10, 15 and 60 minutes post-dosing
timeFrame: 3, 6, 10, 15 and 60 minutes post-dosing
measure: SPID at 15 and 30 minutes according to the pathophysiology of the pain (neuropathic, nociceptive)
timeFrame: 15 and 30 minutes post dose
measure: Pain Intensity Difference at 3, 6, 10, 15, 30 and 60 minutes after dosing
timeFrame: 3, 6, 10, 15, 30 and 60 minutes after dosing
measure: Pain Relief at 3, 6, 10, 15, 30 and 60 minutes after dosing
timeFrame: 3, 6, 10, 15, 30 and 60 minutes after dosing
measure: The proportion of episodes of BTP that required rescue medication
timeFrame: 15 and 30 minutes post dose
measure: the proportion of episodes with more than 33% and 50% of improvement in Pain Intensity scores
timeFrame: 15 and 30 minutes post dose
measure: Recording of safety data
timeFrame: During all the study duration, an expected average of 8 weeks
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Pain Care Units
Study officials:
References:
citation: Novotna S, Valentova K, Fricova J, Richterova E, Harabisova S, Bullier F, Trinquet F; ETHYFYL Study Group. A randomized, placebo-controlled study of a new sublingual formulation of fentanyl citrate (fentanyl ethypharm) for breakthrough pain in opioid-treated patients with cancer. Clin Ther. 2014 Mar 1;36(3):357-67. doi: 10.1016/j.clinthera.2014.01.006. Epub 2014 Feb 5.
Clinical trial NCT02797093: Impact of ART Adherence on HIV Persistence and Inflammation
Official title: Impact of ART Adherence on HIV Persistence and Inflammation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Human Immunodeficiency Virus
Keywords: anti-retroviral therapy
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2016-06-13
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected individuals who are being treated with a tenofovir-based regimen.

Brief summary: The purpose of this study is to evaluate the relationship between anti-retroviral therapy (ART) adherence with levels of human immunodeficiency virus (HIV) reservoir and residual viremia in suppressed, HIV-infected individuals on chronic ART.

Detailed description: Understanding whether the size and dynamics of the HIV reservoir are associated with adherence, measured by an objective biomarker, could have significant clinical and therapeutic implications for ART and HIV cure.

1. First, this aim will quantify levels of CA-RNA, CA-DNA, and plasma residual viremia in suppressed, HIV infected individuals and correlate them with levels of TFV-DP in DBS as a measure of cumulate drug exposure (adherence).
2. Second, this study will evaluate the changes in the HIV reservoir in relation to changes in ART adherence over time.

Eligibility criteria: Inclusion Criteria:

1. HIV-infected males and females,
2. Ages 18 years and older,
3. Taking any TFV-based regimen,
4. HIV suppression \<20 copies/ml for at least 12 months;
5. Not co-infected with HCV;
6. Able and willing to give informed consent.

Exclusion Criteria:

1. Pregnancy.
2. Refusal to participate.

Primary outcomes:
measure: Level of tenofovir diphosphate in dried blood spots associated with the size of the HIV reservoir measured by the amount of CA-RNA and CA-DNA in PBMCs.
timeFrame: 6 months
Secondary outcomes:
measure: Level of self-reported adherence (4-day, 30-day and 3-months using a visual analog scale) associated with the size of the HIV reservoir measured by CA-RNA and CA-DNA in PBMCs.
timeFrame: 6 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado, Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Jose R Castillo-Mancilla, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06574893: Physical Exercise on Simple Inflammatory Markers, Systemic Immune Inflammation Index, and Systemic Immune Response Index
Official title: The Effects of Physical Exercise on Simple Inflammatory Markers, Systemic Immune Inflammation Index, and Systemic Immune Response Index in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Schizophrenia
Physical Exercise
Lead sponsor: Dr. Lutfi Kirdar Kartal Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2024-08-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mental health is defined as a state of well-being in which a person can realize their talents, cope with the normal stresses of life, and support society by working efficiently and productively. In other words, mental health is a dynamic internal balance that enables individuals to use their diversity of skills in harmony with the universal values of society.

Detailed description: The aim of this study was to investigate the effect of physical exercise on simple inflammation markers, systemic immune inflammation index and systemic inflammation response index in patients with schizophrenia. No other study examining the effect of exercise on these parameters was found in the literature. Therefore, considering the importance of our study, our findings may contribute to the literature and improvement for mental health systems, especially for people with psychotic disorders such as schizophrenia.

Eligibility criteria: Inclusion Criteria:

* Individuals diagnosed with schizophrenia by a physician according to DSM-V criteria Patients treated at CMHC Individuals with schizophrenia who are 18 years of age or older

Exclusion Criteria:

* Those who do not consent to participate in the study Patients with a diagnosis other than schizophrenia Pregnancy Patients with chronic metabolic diseases such as diabetes, heart problems and cancer

Primary outcomes:
measure: sociodemographic characteristics.
timeFrame: 12 weeks
measure: simple inflammatory markers
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Kartal Dr Lütfi Kırdar Şehir Hastanesi
Study officials:
References:
Clinical trial NCT01268293: A Study of E7080 in Subjects With Solid Tumor
Official title: A Phase 1 Study of E7080 in Subjects With Solid Tumor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Keywords: Cancer
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2010-12-30
Enrollment: 9
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the tolerability and safety of E7080 up to 24 mg when administered orally on a once daily continuous dose schedule in cycles (4 weeks as 1 cycle) in subjects with solid tumors


Eligibility criteria: Inclusion Criteria

* Subjects with histologically and/or cytologically diagnosis of solid tumor
* Subjects with solid tumor which is resistant to standard anti-tumor therapies, or which no appropriate treatment is available
* Subjects whose toxicity of previous treatment has recovered to Grade 1 or lower toxicity (except for alopecia)
* Subjects who completed previous anti-tumor therapy before at least 4 weeks
* Subjects who are 20 years or older
* Subjects with 0 to 1 of Performance Status
* Subjects agree to be hospitalized for DLT observation
* Subjects with adequate organ functions
* Males and females of childbearing potential must agree to use appropriate contraception from the agreement to 30 days after study drug administration.
* Agree to participate in this study in writing based on voluntary will

Exclusion Criteria

* Subjects with brain metastasis accompanying clinical symptoms or requiring treatment
* Subjects with the severe complication or disease history
* Subjects unable to take oral medication.
* Subjects being treated with drugs that strongly inhibit or induce CYP3A4 and that may be possibly used during this study.
* Scheduled for surgery during the projected course of the study.
* Positive for human immunodeficiency virus (HIV antibody) test or positive for hepatitis B surface (HBs antigen) or hepatitis C (HCV antibody) by serum test.
* Subjects who in the view of the investigator are not able to comply with this protocol because of psychiatric or physical diseases including alcoholism or drug addict
* Pregnant or nursing subjects
* Subjects who are participating in another clinical trial.

Primary outcomes:
measure: Number of Participants With Dose Limiting Toxicity (DLT)
timeFrame: Up to 4 weeks
measure: Number of Participants With Adverse Events
timeFrame: Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
Secondary outcomes:
Other outcomes:
Locations:
city: Chuo-ku
country: Japan
state: Tokyo
Study officials:
affiliation: Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd.
name: Tatsuya Sasaki
role: STUDY_DIRECTOR
References:
Clinical trial NCT05988593: Testing the Cognitive Facilitation Effect by Dietary Supplementation of MelaGene+ Drink
Official title: Testing the Cognitive Facilitation Effect by Dietary Supplementation of MelaGene+ Drink
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To assess the efficacy of MelaGene+ on cognitive performance


Eligibility criteria: Inclusion Criteria:

* 20 to 65-year-old males or females

Exclusion Criteria:

* Participants are breastfeeding, pregnant or planning to become pregnant during the test (self-report)
* Participants with heart, liver, kidney, endocrine and other major organic diseases (self-reported)
* Participants take drugs for a long time (self-report)
* Participants with mental illness or have undergone brain surgery
* Participants still can not clearly see words with 12pt on computer after corrected vision

Primary outcomes:
measure: The change of Match to sample test
timeFrame: Change from Baseline match to sample test value at 8 weeks
measure: The change of Trail making test
timeFrame: Change from Baseline Trail making test value at 8 weeks
measure: The change of Processing speed test
timeFrame: Change from Baseline Processing speed test value at 8 weeks
measure: The change of Mnemonic Similarity Task
timeFrame: Change from Baseline Mnemonic Similarity Task value at 8 weeks
measure: The change of facial expression cuing task
timeFrame: Change from Baseline facial expression cuing task value at 8 weeks
measure: The change of State-trait anxiety inventory
timeFrame: Change from Baseline State-trait anxiety inventory value at 8 weeks
measure: The change of score of fatigue
timeFrame: Change from Baseline PSS (The Perceived Stress Scale)-14 value at 8 weeks
measure: The change of score of life quality
timeFrame: Change from Baseline WHOQOL-BREF (The World Health Organization Quality of Life Brief Version) value at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University
Study officials:
affiliation: China Medical University, China
name: Jing-Ling Li
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05671393: the Optimal Surveillance Frequency for Patients With Gastric Neuroendocrine Carcinoma
Official title: A Multi-institution Real-world Study of the Optimal Surveillance Frequency for Patients With Gastric Neuroendocrine Carcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Neuroendocrine Carcinoma
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 801
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 801 G-NEC patients from 21 centers in China were included.

Brief summary: Due to lacking of evidence on surveillance for gastric neuroendocrine carcinoma (G-NEC), this study aimed to determine the optimal postsurgical surveillance strategy for G-NEC patients and compare its cost-effectiveness with traditional surveillance strategies.

Detailed description: The development of existing follow-up strategies is mainly based on experts' consensus and researches on recurrence patterns due to the lack of direct evidence and unified standards. On the one hand, it is unreasonable to carry out the same postoperative surveillance for all G-NEC patients. In addition to the early detection of recurrence, the optimal follow-up strategy should also balance cost and effectiveness. There were no criteria for the arrangement of follow-up in different guidelines, and the optimal postoperative follow-up strategy for patients with G-NEC remains unclear. Patients with G-NEC from 21 centers in China were included. Cost-effectiveness were assessed by Markov model.

Eligibility criteria: Inclusion Criteria:This multicentre retrospective study included patients with gastric neuroendocrine neoplasms who underwent surgery in 21 centres of the Study Group for Gastric Neuroendocrine Tumours in China from January 2008 to December 2016. Radical surgery included a D2 lymphadenectomy consistent with the Japanese gastric cancer treatment guidelines.

Exclusion Criteria: Patients with tumours of unknown pathology (only neuroendocrine neoplasms recorded without detailed information); patients with gastric NETs; patients who had endoscopic submucosal dissection or endoscopic mucosal resection; patients who received neoadjuvant chemotherapy; patients who died within 3 months of surgery from postoperative complications; and patients with unknown tumour size or who were lost to follow-up

Primary outcomes:
measure: recurrence rate
timeFrame: 60 months
Secondary outcomes:
measure: Delayed-detection months
timeFrame: 60 months
measure: Incremental cost-effectiveness ratios (ICERs)
timeFrame: 60 months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Chang-ming Huang
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Chang-ming Huang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01247493: Modified-FLAI Induction and Consolidation Chemotherapy in Elderly Patient With Acute Myeloid Leukemia (AML)
Official title: Multicenter, Phase 2 Clinical Trial Evaluating the Efficacy and Tolerability of Induction and Consolidation Chemotherapy Comprising Fludarabine, Cytarabine, and Attenuated-dose Idarubicin in Elderly Patients With AML(Acute Myeloid Leukemia)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Myeloid Leukemia
Keywords: fludarabine
AML
Efficacy
tolerability
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2010-11-24
Enrollment: 108
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A phase II clinical trial evaluating the efficacy and tolerability of induction and consolidation chemotherapy comprising Fludarabine, cytarabine and attenuated-dose Idarubicin (modified-FLAI) in the elderly patients with acute myeloid leukemia.


Eligibility criteria: Inclusion Criteria:

* previously untreated AML (excluding acute promyelocytic leukemia)
* age greater than 60 years old
* ECOG PS (Eastern Cooperative Oncology Group Performance scale) less than 2
* adequate hepatic/ renal/ cardiac function

Exclusion Criteria:

* acute promyelocytic leukemia
* significant cardiac disease
* combined non-hematologic malignancy
* aleukemic leukemia (only granulocytic sarcoma)
* CNS (Central Nervous system) involvement
* significant comorbidity/ uncontrollable bleeding tendency

Primary outcomes:
measure: Complete remission rate
Secondary outcomes:
measure: Rate of serious adverse events (SAE)
measure: Event Free Survival
measure: overall survival
measure: Predictive factors for Complete remission
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: professor
name: Inho Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim I, Koh Y, Yoon SS, Park S, Kim BK, Kim DY, Lee JH, Lee KH, Cheong JW, Lee HK, Kim SH, Kim H, Joo YD, Lee SM, Won JH, Park SK, Hong DS, Kim SH, Sohn SK, Kim CS, Park E, Kim MK, Park MR, Lee JH, Min YH; Korean Society of Hematology AML/MDS working party. Fludarabine, cytarabine, and attenuated-dose idarubicin (m-FLAI) combination therapy for elderly acute myeloid leukemia patients. Am J Hematol. 2013 Jan;88(1):10-5. doi: 10.1002/ajh.23337. Epub 2012 Oct 17.
Clinical trial NCT01732393: Effect of Quercetin in Prevention and Treatment of Oral Mucositis
Official title: Effect of Quercetin in Prevention and Treatment of Chemotherapy Induced Oral Mucositis in Blood Dyscrasias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chemotherapy Induced Oral Mucositis
Keywords: Quercetin
Chemotherapy
Mucositis
Hematologic Malignancies
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-11-22
Enrollment: 20
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to evaluate the effect of Quercetin (a natural flavonoid) on prevention of and treatment of chemotherapy-induced oral mucositis in patients with blood malignancies.


Eligibility criteria: Inclusion Criteria:

* patient under chemotherapy
* for a hematologic malignancy
* the hematologist permits the trial on the patient
* agreement of patient for participating in the trial

Exclusion Criteria:

* presence pf ANY oral lesion at the beginning of the trial
* loss of follow up
* use of digoxin and cyclosporine
* patient death

Primary outcomes:
measure: lower grade of mucositis
timeFrame: 3 weeks
Secondary outcomes:
measure: duration of mucositis
timeFrame: 3 weeks of study tiem span and after trial
Other outcomes:
Locations:
city: MAshhad
country: Iran, Islamic Republic of
facility: Oral Medicine Department of Mashhad dental School
state: Khorasan Razavi
Study officials:
affiliation: Mashhad University of Medical Sciences
name: Pegah Mosannen Mozafari, assistant professor
role: STUDY_DIRECTOR
References: