louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01776814: Comparison of the Efficacy of Entecavir and Tenofovir Monotherapy for the Treatment of Nucleos(t)Ide-naïve Patients With Chronic Hepatitis B in Korea
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Hepatitis B
Keywords: Entecair
Tenofovir
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
First posted: 2013-01-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: treatment of nucleos(t)ide-naive patients who were diagnosed with chronic hepatitis B in Korea

Brief summary: Chronic hepatitis B virus infection is an important cause of morbidity and mortality. Tenofovir disoproxil fumarate and entecavir were licensed for the treatment of hepatitis B virus infection. In this study, the investigators will try to make comparison between Entecavir and Tenofovir and investigate the efficacy.


Eligibility criteria: Inclusion Criteria:

* 18 \< Age \< 70
* HBV DNA \> 100,000 copies/mL and increased ALT over 2 times compared with normal range if HBsAg (+), HBeAg (+)
* HBV DNA \> 10,000 copies/mL and increased ALT compared with normal range if HBsAg (+), HBeAg (-)

Exclusion Criteria:

* With HCV or other liver disease
* With kidney disease
* decompensated liver cirrhosis
* with hepatocellular carcinoma
* refuse this clinical trials

Primary outcomes:
measure: virologic response
timeFrame: changes from baseline HBV DNA level at 3, 6, 9, 12 months after taking entecavir or tenofovir
Secondary outcomes:
measure: reduction of alanine transaminase
timeFrame: changes from baseline ALT level at 3,6,9,12 months after taking entecavir or tenofovir
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center, Department of Gastroenterology
Study officials:
References:
Clinical trial NCT05086614: Thymosin-alpha 1 for Adjuvant Treatment After Radical Resection of High-risk Stage II and III Colorectal Cancer
Official title: The Efficacy and Safety of Thymosin-alpha 1 Used for Adjuvant Treatment After Radical Resection of High-risk Stage II and Stage III Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Stage II Colorectal Cancer
Stage III Colorectal Cancer
Keywords: colorectal cancer
adjuvant treatment
thymosin-alpha 1
disease-free survival
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with pathological high-risk stage II and stage III colorectal cancer after radical resection were randomly allocated to receive thymosin-alpha 1 or not in a 1:1 ratio.
Primary purpose: TREATMENT

Brief summary: For high-risk stage II and stage III colorectal cancer, even after radical resection and postoperative adjuvant chemo/radiotherapy, 30-40% of patients will still have recurrence and metastasis. Thymosin-alpha 1 is believed to improve immunity and may help promote tumor immunity to reduce the incidence of recurrence and metastasis. This study hopes to verify the effecacy and safety of thymosin-alpha 1 for adjuvant treatment of high-risk stage II and stage III colorectal cancer after radical resection.

Detailed description: Patients with pathological high-risk stage II and stage III colorectal cancer after radical resection were randomly allocated to receive thymosin-alpha 1 twice a week for 6 months (experimental group) or not (control group) in a 1:1 ratio. At the same time, all patients will receive chemo/radiotherapy according to the Chinese Standards for Diagnosis and Treatment of Colorectal Cancer. The primary endpoint is 3-year DFS rate.

Eligibility criteria: Inclusion Criteria:

* Colorectal cancer receiving radical resection
* Pathologically diagnosed with high-risk stage II or stage III
* Eastern Cooperative Oncology Group performance status of 0-2
* Adequate hepatic, renal, and hematologic function

Exclusion Criteria:

* Had previously taken any immune-promoting drugs
* Pregnancy or lactation

Primary outcomes:
measure: 3-year disease-free survival rate
timeFrame: 3 years
Secondary outcomes:
measure: 3-year overall survival rate
timeFrame: 3 years
measure: rate of adverse events related to thymosin-alpha 1
timeFrame: 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
References:
Clinical trial NCT06354595: Feasibility Study of Multidimensional Rehabilitation in the Metaverse
Official title: Feasibility Study of Multidimensional Rehabilitation in the Metaverse
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colorectal Neoplasms
Keywords: Metaverse multi-dimensional rehabilitation platform
Lead sponsor: Xiamen University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Xiamen University
First posted: 2024-04-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The investigators evaluated and optimized the Metaverse multi-dimensional rehabilitation platform based on the use of the Metaverse multi-dimensional rehabilitation platform by colorectal cancer survivors and their families, and finally launched the Metaverse multi-dimensional rehabilitation platform.

Detailed description: The investigatorse intend to invite colorectal cancer survivors and their families to use the metaverse multi-dimensional rehabilitation platform. Interviews with users, user experience optimization of the metaverse multi-dimensional rehabilitation platform, and then evaluation of the platform through system usability evaluation. Gain insight into the experience of colorectal cancer survivors using the metaverse multi-dimensional rehabilitation platform, and understand their opinions and suggestions to explore the usability of the metaverse multi-dimensional rehabilitation platform.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing adjuvant therapy after radical colorectal cancer resection; Age over 18 years old, under 65 years old, non-pregnant; Volunteering to participate in the research of this topic; Mobile phones are available

Exclusion Criteria:

* Patients with multiple cancers; Have special dietary needs.

Primary outcomes:
measure: Post-Study System Usability Questionnaire (PSSUQ) Third Edition
timeFrame: 4th week
measure: System Usability Scale (SUS)
timeFrame: 4th week
Secondary outcomes:
measure: Semi-structured interview
timeFrame: 4th week
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Yuru Hu
state: Fujian
Study officials:
affiliation: Xiamen University School of Medicine
name: Yuru HU
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02254395: PINS Stimulator System for Deep Brain Stimulation to Treat Obesity
Official title: PINS Stimulator System for Deep Brain Stimulation to Treat Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Obesity
Lead sponsor: Beijing Pins Medical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Beijing Tiantan Hospital
First posted: 2014-10-01
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical study is to verify the long term effecacy and safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a treatment option for patients with obesity.


Eligibility criteria: Inclusion Criteria:

1. Subject is aged 18 to 65.
2. Body Mass Index \[BMI\] \>40 kg/m2.

Exclusion Criteria:

1. Medical contraindications for general anesthesia, craniotomy, or DBS surgery
2. Evidence of neurological disorders, e.g., multiple sclerosis, Parkinson's disease and ischemic stroke, or severe brain atrophy or the presence of subdural hygromas or subdural hematomas.
3. Participate in other clinical trial;
4. Has a life expectancy of \< 1 year.
5. The investigator and/or enrollment review committee, would preclude participation in the study.

Primary outcomes:
measure: Body Weight
timeFrame: 12 month
Secondary outcomes:
measure: Body Mass Index (BMI)
timeFrame: 12 month
measure: Food Intake
timeFrame: 12 month
Other outcomes:
Locations:
Study officials:
affiliation: Tsinghua University
name: Li Luming, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05675995: Qigong for Post Acute Sequelae of COVID-19 Infection
Official title: Qigong for Post Acute Sequelae of COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Long COVID
Keywords: Qigong
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2023-01-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, waitlist controlled design
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to conduct a pilot feasibility study of external qigong on health-related quality of life in individuals with prolonged symptoms following COVID-19 infection.

Detailed description: The purpose of this study is to determine whether external qigong, a traditional Chinese medicine healing practice, improves quality of life and symptoms for individuals with prolonged symptoms following a COVID-19 infection (sometimes called "long COVID"). The study involves completing questionnaires and participating in 6 weekly in person small group qigong sessions with an experienced qigong practitioner.

Participants will be randomized to participate in either an immediate or waitlist control group that will receive the qigong sessions starting 8 weeks later. Participants will complete 3 sets of questionnaires, each about 8 weeks apart and an interview about their experiences with qigong after completing the 6 sessions.

Eligibility criteria: Inclusion Criteria:

1. English-speaking adults age 18 or greater
2. History of a COVID-19 infection with lingering symptoms lasting longer than 12 weeks
3. Willing and able to access the internet to complete questionnaires
4. Willing and able to travel to the qigong sessions to participate in person in Sacramento, CA.

Exclusion Criteria:

1. Lung scarring secondary to COVID-19 infection as evidenced by signs of parenchymal lung damage on imaging or FVC \< 80% (any patient with post COVID-related shortness of breath must have PFTs to be considered for enrollment).
2. Dementia
3. Any other condition that makes it difficult for the individual to complete questionnaires or attend the qigong sessions.

Primary outcomes:
measure: Change in physical health
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis Health
state: California
Study officials:
References:
Clinical trial NCT05166395: Laser Treated Scars and Optical Coherence Tomography (OCT)
Official title: Treatment of Surgical Scar With 2940 nm Erbium: Yttrium Aluminum Garnet (YAG) Laser Examined Under Optical Coherence Tomography
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Scar
Keywords: surgical scar
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2021-12-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research study is to learn about the effects of the 2940 nm Erbium: Yttrium-Aluminum-Garnet (Er:YAG) laser on treating surgical scar using optical coherence tomography, a medical imaging device.


Eligibility criteria: Inclusion Criteria:

1. Adults age 18 years or older
2. Patients should have Fitzpatrick skin types of I-IV
3. Patients should have mild to severe post-surgical scarring located on head and neck
4. Scar lengths of at least 3 cm.
5. Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

1. The patient should not be receiving any additional systemic, topical, or intralesional treatment of the scars during the study
2. Scar size less than 3 cm in length
3. Pregnant or lactating females
4. Fitzpatrick skin type of V-VI
5. Scleroderma
6. Photosensitivity
7. Botulinum toxin injection, facial laser resurfacing, chemical peels, fillers, or usage of oral retinoid within the last 6 months.

Primary outcomes:
measure: POSAS Scar Assessment
timeFrame: Up to 13 weeks
measure: Surgical Scar Blood Flow
timeFrame: Up to 13 weeks
measure: Surgical Scar Skin Roughness
timeFrame: Up to 13 weeks
measure: Surgical Scar Collagen Content
timeFrame: Up to 13 weeks
measure: Surgical Scar Epidermal Thickness
timeFrame: Up to 13 weeks
Secondary outcomes:
measure: Incidence of Adverse Events
timeFrame: Up to 13 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Keyvan Nouri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01670695: A Prospective Cohort Study of IgG4RD in China
Official title: Cohort Study of Patients With IgG4-Related Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: IgG4-related Disease
Keywords: IgG4-related disease
IgG4-RD
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2012-08-22
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with newly diagnosed IgG4-related disease.

Brief summary: This is an cohort study to investigate the disease course and treatment response of patients with IgG4-related disease.

Detailed description: Immunoglobulin G4-related disease (IgG4-RD) is a recently defined emerging clinical entity characterized by tissue infiltration by IgG4-positive plasma cells, tissue fibrosclerosis and elevated serum IgG4 concentration.

In this study, patients with IgG4-RD will be investigated, including clinical presentation, laboratory findings and imaging study. All patients will be treated by standard care and follow-uped for at least 6 months.

Eligibility criteria: Inclusion Criteria:

* Males and females
* Age 18-75 years old with informed consent
* Patients with IgG4-RD:

  1. swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions;
  2. elevated serum IgG4 (\>1.35 g/L)
  3. histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed);
  4. exclusion of other diseases.

Exclusion Criteria:

* Females planning to bear a child recently or with childbearing potential
* Concurrent severe and/or uncontrolled and/or unstable diseases
* Patient with malignancy

Primary outcomes:
measure: Clinical Response
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Deptment of Rheumatology, Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Deptment of Rheumatology, Peking Union Medical College Hospital
name: Wen Zhang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Deptment of Rheumatology, Peking Union Medical College Hospital
name: Fengchun Zhang
role: STUDY_CHAIR
References:
citation: Luo X, Peng Y, Zhang P, Li J, Liu Z, Lu H, Zhang X, Zeng X, Zhang F, Fei Y, Zhang W. Comparison of the Effects of Cyclophosphamide and Mycophenolate Mofetil Treatment Against Immunoglobulin G4-Related Disease: A Retrospective Cohort Study. Front Med (Lausanne). 2020 Jul 7;7:253. doi: 10.3389/fmed.2020.00253. eCollection 2020.
Clinical trial NCT03995095: Intervention in Spirituality at the End of Life. The Kibo Protocol
Official title: Intervention in Spirituality at the End of Life. The Kibo Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palliative Care
Keywords: Spirituality
Intervention Study
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Sociedad Española de Cuidados Paliativos SECPAL
First posted: 2019-06-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This work aims to study the benefits that the therapeutic interview Kibo in palliative care patients can have for spirituality.

A parallel randomized controlled trial of two groups was performed. Information was collected on 60 palliative care patients during the moments before and after the intervention.


Eligibility criteria: Inclusion Criteria:

1. To be 18 or more years of age.
2. Being in advanced or terminal disease phase (following World Health Organization criteria).
3. To have preserved cognitive capacity.
4. To have signed the informed consent.

Exclusion Criteria:

a) Estimated time of survival: Patients with a life expectancy of two weeks or less will not be intervened.

Primary outcomes:
measure: Change in the dimension of spirituality (PRE and POST measures)
timeFrame: Baseline up to 4 weeks
Secondary outcomes:
measure: Change in resilience (PRE and POST measures)
timeFrame: Baseline up to 4 weeks
measure: Change in demoralization (PRE and POST measures)
timeFrame: Baseline up to 4 weeks
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Universitat de València
Study officials:
affiliation: Universitat de València
name: Pilar Barreto Martin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Soto-Rubio A, Perez-Marin M, Rudilla D, Galiana L, Oliver A, Fombuena M, Barreto P. Responding to the Spiritual Needs of Palliative Care Patients: A Randomized Controlled Trial to Test the Effectiveness of the Kibo Therapeutic Interview. Front Psychol. 2020 Aug 21;11:1979. doi: 10.3389/fpsyg.2020.01979. eCollection 2020.
Clinical trial NCT02416895: Vitamin D Status and Immune Function
Official title: Vitamin D Status and in Vivo Immune Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Lead sponsor: Bangor University
Sponsor class: OTHER
Collaborators: name: University of East Anglia
First posted: 2015-04-15
Enrollment: 264
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young adults who are starting basic training in the army.

Brief summary: The purpose of this study is to examine the relationship between Vitamin D status and immunity.

Detailed description: Vitamin D is mainly obtained from the sun and follows a seasonal pattern, with Vitamin D levels peaking in summer and reaching a trough during winter. Vitamin D deficiency is associated with impaired immunity. However, knowledge of Vitamin D deficiency with in vivo immunity is limited. This observational study aims to investigate the relationship between Vitamin D status and the in vivo immunity.

Eligibility criteria: Inclusion Criteria:

* Passed medical assessment by medical doctor
* Passed audio test (this is part of medical assessment)
* Met physical fitness requirements

Exclusion Criteria:

• Medically deferred by medical doctor

Primary outcomes:
measure: Vitamin D measured by liquid chromatography tandem mass spectroscopy
timeFrame: Up to 20 months
Secondary outcomes:
measure: Immune function measured by analytic biochemistry assay
timeFrame: Up to 20 months
Other outcomes:
Locations:
city: Catterick
country: United Kingdom
facility: Infantry Training Centre
state: North Yorkshire
Study officials:
affiliation: HQ Army Research and Training Division
name: Julie Greeves, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kashi DS, Oliver SJ, Wentz LM, Roberts R, Carswell AT, Tang JCY, Jackson S, Izard RM, Allan D, Rhodes LE, Fraser WD, Greeves JP, Walsh NP. Vitamin D and the hepatitis B vaccine response: a prospective cohort study and a randomized, placebo-controlled oral vitamin D3 and simulated sunlight supplementation trial in healthy adults. Eur J Nutr. 2021 Feb;60(1):475-491. doi: 10.1007/s00394-020-02261-w. Epub 2020 May 10.
citation: Tang JCY, Jackson S, Walsh NP, Greeves J, Fraser WD; Bioanalytical Facility team. The dynamic relationships between the active and catabolic vitamin D metabolites, their ratios, and associations with PTH. Sci Rep. 2019 May 6;9(1):6974. doi: 10.1038/s41598-019-43462-6.