louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05199623: The Effect of Chinese Herbal Medicine as an Adjuvant Therapy in the Treatment of Traumatic Anosmia
Official title: The Effect of Chinese Herbal Medicine(Tailored Guizhi Decoction) as an Adjuvant Therapy in the Treatment of Traumatic Anosmia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Anosmia
Keywords: Chinese herbal medicine
Guizhi decoction
Olfactory training
Phenyl ethyl alcohol threshold test
Traumatic anosmia
University of Pennsylvania Smell Identification Test
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2022-01-20
Enrollment: 77
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: Objective: To investigate the effect of Chinese herbal medicine (CHM) as an adjuvant therapy in the treatment of traumatic anosmia.

Methods: Patients with a clear history of loss of smell after head injury, and whose phenyl ethyl alcohol (PEA) odor detection threshold remained -1 after treatment with steroid, zinc, and olfactory training (OT) for one month, were included in this study between September of 2018 and November of 2020. They were randomly divided into 2 groups, with patients in the CHM group taking CHM (tailored Guizhi decoction) and performing OT, and those in the OT group receiving OT only for 6 months. After 3 months' and 6 months' treatment, the olfactory function was evaluated by both the PEA threshold test and the traditional Chinese version of the University of Pennsylvania Smell Identification Test (UPSIT-TC). Magnetic resonance imaging was performed to measure the volume of olfactory bulbs after 6 months' treatment.


Eligibility criteria: Inclusion Criteria:

* a clear history of loss of smell after an episode of head injury
* PEA threshold was -1, which is assumed to be anosmic

Exclusion Criteria:

* One month later, they received birhinal and unirhinal PEA threshold tests. Any patient whose birhinal or unirhinal threshold was below -1 was excluded from the study.

Primary outcomes:
measure: Olfactory test - Birhinal PEA threshold (3 months after treatment)
timeFrame: Change between before treatment and 3 months after treatment
measure: Olfactory test - Birhinal PEA threshold (6 months after treatment)
timeFrame: Change between before treatment and 6 months after treatment
measure: Olfactory test - UPSIT-TC (3 months after treatment)
timeFrame: Change between before treatment and 3 months after treatment
measure: Olfactory test - UPSIT-TC (6 months after treatment)
timeFrame: Change between before treatment and 6 months after treatment
measure: The volume of olfactory bulbs
timeFrame: 6 months after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Departments of Medical Research, Otolaryngology, Taichung Veterans General Hospital
name: Rong-San Jiang
role: STUDY_CHAIR
References:
Clinical trial NCT00949923: Green Tea in Breast Cancer Patients
Official title: Green Tea Supplement in Women With Incident Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incident Breast Cancer
Keywords: Postmenopausal women
Suspicious for breast ca
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2009-07-31
Enrollment: 41
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Prognostic factors for breast cancer beyond stage at diagnosis and tumor characteristics have not been well studied. Of special interest are lifestyle factors that can be modified by women after diagnosis to increase disease-free survival. Green tea is rich in polyphenols consisting primarily of epicatechins, epigallocatechin, epicatechin gallate, and epigallocatechin gallate (EGCG). The investigators hypothesize that there will be a reduction in proliferation and/or an increase in apoptosis in association with short-term EGCG treatment.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal (at least 2 years since last menstrual period) or age 55 or older if prior hysterectomy
* Non-current (not with past 6 months) user of menopausal hormones
* Mammographic abnormality consistent with any type of incident breast cancer necessitating a diagnostic biopsy (BIRAD IV(b), (c) or V) will be sufficient to draw baseline LFT and complete screening questionnaire. Unless the biopsy confirms incident breast cancer, such subjects will not be included in further research interventions and they will not serve as EGCG treated or control subjects.
* Diagnosed with incident breast cancer on the diagnostic biopsy is required for inclusion in the EGCG or control treatment groups.
* Non-green tea drinker (less than monthly) - this criteria does not apply to black tea or herbal tea
* Provided written informed consent

Exclusion Criteria:

* Green tea drinker (once per month or more)
* History of breast cancer or other cancer including a prior diagnosis of any type of incident breast cancer.
* Known allergy to tea
* Abnormal liver enzymes (plus or minus 10% of the normal ranges).

Primary outcomes:
measure: level of reduction in proliferation or increase in apoptosis in association with short-term EGCG
timeFrame: At surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Anna Wu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02194023: Clinical Effects of Two New Chlorhexidine Digluconate Formulations: 0.12% and 0.03%.
Official title: Inhibition of de Novo Plaque Formation and Side Effects of Two New Mouthrinse Formulations: 0.12% and 0.03% Chlorhexidine Digluconate, Respectively, in a 4-day Non-brushing Model. A Triple-blind, Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Plaque
Side Effects
Keywords: chlorhexidine digluconate
gingivitis
cetylpyridinium chloride
mouthrinse
dental plaque
de novo
in vivo
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
Collaborators: name: Dentaid SL
First posted: 2014-07-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: In the current study we tested the hypothesis that new 0.05% Cetylpyridinium chloride (CPC) mouthrinse formulations containing 0.12% or 0.03% chlorhexidine digluconate (CHX): 1) yield similar or better clinical results regarding the inhibition of de novo plaque growth compared to those achieved with an already marketed 0.12% CHX mouthrinse (Perio-Aid Treatment without alcohol. Dentaid, Spain), 2) reduce the side effects caused by the marketed 0.12% CHX formula and 3) that these mouthrinses have no negative microbiological effects, and they control total bacterial loads.


Eligibility criteria: Inclusion Criteria:

* 18-30 years
* Good overall health without medical history or medications that could interfere with the study conduct.
* Minimum of 6 teeth per quadrant.
* Absence of probing depths ≥4mm.

Exclusion Criteria:

* Allergy to CHX or to CPC.
* Continuous use of CHX or of any other oral antiseptic in the months prior to the study.
* Any adverse medical background or long-term medications that could affect gingival conditions.
* Having taken antibiotics in the previous three months.
* Moderate to severe gingivitis (bleeding on probing ≥ 40%). 41(Van der Weijden et al. 1994).
* Pregnancy or breastfeeding.
* Smokers of more than 5 cigarettes per day.
* Orthodontic appliances.
* Fixed or removable prostheses.
* Systemic diseases that increase the risk for gingival diseases (diabetes mellitus, immunosuppression).
* Severe dental crowding.

Primary outcomes:
measure: Percentage of participants with greater reduction of plaque regrowth and side effects.
timeFrame: Baseline to 4 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Sant Cugat
country: Spain
facility: UIC dental office, Hospital General de Catalunya
state: Barcelona
Study officials:
affiliation: Universitat Internacional de Catalunya
name: Carolina Mor-Reinoso
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01286623: The Pharmacology/Aging Clinic
Official title: Study Title: The Pharmacology/Aging Clinic: Clinical Routine Monitoring of HIV-infected Patients Over 50 Year of Age.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: HIV Infection
Lead sponsor: St Stephens Aids Trust
Sponsor class: OTHER
First posted: 2011-01-31
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV-infected patients over 50 years of age

Brief summary: The treatment of HIV and the tests performed for HIV care have changed over the last 20 years. However, improvement of management of HIV-infected subjects is still warranted, especially as the HIV-infected population is aging. Therefore, this study will involve the collection and analysis of clinical information obtained from subjects who are over 50 years of age. For example, patients' risk of heart disease will be measured and monitored by looking at blood tests and clinical data (such as blood pressure). This will allow researchers to understand if the current way of assessing the risk of future heart disease is the best one available for HIV-infected individuals. No genetic research will be done.

Detailed description: Patients will be asked to read the information contained in this leaflet. No extra visits will occur; all samples will be collected at their routine visits to the pharmacology clinic. All blood samples and results will be managed by the routine clinical laboratory at Chelsea and Westminster Hospital, with the exception of the assessment of the hsCRP. The latter is a marker of inflammation that is measured to be able to add more information when cardiovascular risk is assessed. The blood sample for this test is sent to a laboratory in London called The Doctors Laboratory (TDL). All shipped samples are anonymous and patient names will not be disclosed outside the Hospital.

The clinical visits will be scheduled approximately once within one year. However, extra visits may be clinically necessary if a clinical condition requires proper follow-up. Furthermore, clinical details will be marked to show patients have agreed to their use for this research study.

Eligibility criteria: Inclusion Criteria:

1. The ability to understand and sign a written informed consent form
2. HIV-infected patients attending the Pharmacology/Aging Clinic (HIV/GUM Directorate, Chelsea and Westminster Hospital NHS Foundation Trust)

Exclusion Criteria:

None

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St Stephen's Centre
Study officials:
affiliation: St Stephen's AIDS Trust
name: Marta Boffito, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06757023: A Clinical Follow-up Study on the Efficacy of Thumbtack Needle for Postoperative Sleep and Recovery Treatment
Official title: A Clinical Follow-up Study on the Efficacy of Thumbtack Needle for Postoperative Sleep and Recovery Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Postoperative Complications
Postoperative Pain
Acupuncture
Lead sponsor: The First Affiliated Hospital of Xiamen University
Sponsor class: OTHER
First posted: 2025-01-03
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing breast cancer surgery with general anesthesia in the hospital

Brief summary: To understand the impact of thumb-tack needle therapy on postoperative sleep and recovery in patients who have undergone general anesthesia, and to explore the clinical significance of thumb-tack needle therapy in improving postoperative sleep quality, preventing postoperative sleep disorders, and promoting postoperative recovery


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing breast cancer surgery with general anesthesia in the hospital;
2. American Society of Anesthesiologists (ASA) classification I-II;
3. Women aged 18-55 years;
4. No history of chronic insomnia;
5. Individuals who have not taken sedative-hypnotic drugs within the past month.

Exclusion Criteria:

1. Those who do not meet the aforementioned inclusion criteria;
2. A history of severe heart, brain, lung, or kidney diseases (such as acute coronary syndrome (ACS), severe heart failure classified as NYHA Class III or IV, severe arrhythmias, severe valvular disease; acute aortic disease, and severe peripheral vascular disease, etc.), or poor physical condition (including reduced exercise tolerance, multi-organ dysfunction, malnutrition, etc.);
3. A history of sleep disorders and psychiatric history;
4. Inability to receive thumb-tack needle treatment.

Primary outcomes:
measure: Pittsburgh sleep quality index(PSQI)
timeFrame: 1 day or 2 days before anesthesia exposure and 1, 3, and 7 days after anesthesia exposure.
Secondary outcomes:
measure: Later Recovery evaluated by QoR-40 questionnaire
timeFrame: QoR-40 score on the third day after surgery
Other outcomes:
Locations:
city: Xiamen
country: China
facility: First Affiliated Hospital of Xiamen University
state: Fujian
city: Xiamen
country: China
facility: First Affiliated Hospital of Xiamen University
state: Fujian
Study officials:
References:
Clinical trial NCT04404023: Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of UB-221 in Healthy Volunteers
Official title: A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of a Single Dose of UB-221 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Chronic Spontaneous Urticaria
Lead sponsor: UBP Greater China (Shanghai) Co., Ltd
Sponsor class: INDUSTRY
First posted: 2020-05-27
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of a single dose of UB-221 in healthy volunteers.

Detailed description: This is a phase I, open-label, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics,and immunogenicity of a single dose of UB-221 in healthy volunteers.

Eligibility criteria: Inclusion Criteria:

* Subjects with age between 20 to 65 years old (inclusive).
* Subjects who are able and willing to provide the informed consent.
* Male subjects with body weight of 50 kilogram (kg) or above; female subjects body weight of 45 kilogram (kg) or above.
* Researchers based on medical history, physical examination, vital signs, clinical laboratory results and 12-lead electrocardiogram identified healthy subjects without clinically significant abnormalities

Exclusion Criteria:

• The investigator considered that the subjects were not suitable to participate in this study.

Primary outcomes:
measure: 1.Adverse event incidence
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03897023: Gut Microbiota Pilot Study
Official title: Anaylsis of Gut Microbiota in ICU
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Microbiota
Metabolism
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2019-04-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Stable adult patient who are admitted to ICU

Brief summary: Microbiota is known to effect metabolism. This is pilot study to get status of microbiota from normal control. It will be compared to data from specific patients in ICU via further study.

Detailed description: Microbiota is known to effect metabolism. This is pilot study to get status of microbiota from normal control. It will be compared to data from specific patients in ICU via further study.

Eligibility criteria: Inclusion Criteria:

* Older than 17 years old
* Every patients who are admitted to ICU

Exclusion Criteria:

* With history of disease such as cancer, Crohn's disease, ulcerative colitis, irritable bowel syndrome
* With history of immunosuppressive agents.
* Initial systolic blood pressure \<100
* Initial pulse rate \> 100
* Need emergent operation at brain or torso
* Need vasopressor, transfusion

Primary outcomes:
measure: Stuatus of gut microbiota in stable patient
timeFrame: 1 Month
Secondary outcomes:
Other outcomes:
Locations:
city: Uijeongbu-si
country: Korea, Republic of
facility: Uijeongbu St.Mary's hospital
state: Gyeonggi-do
Study officials:
References:
Clinical trial NCT04491123: Intrathecal Analgesia Effects on Cancer Patients Discomfort Symptoms
Official title: Evaluation of Discomfort Symptoms in Patients With Refractory Cancer Pain and Intrathecal Analgesia Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractory Cancer Pain
Intrathecal Analgesia
Keywords: Refractory cancer pain
intrathecal analgesia
pain management
discomfort symptoms management
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Institut du Cancer de Montpellier - Val d'Aurelle
name: Centre Hospitalier Universitaire de Nīmes
name: Oncopole Toulouse
First posted: 2020-07-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cancer patients with refractory localized cancer pain because of drug side effects or intractable pain who will receive intrathecal analgesia.

Brief summary: Intrathecal analgesia is used in refractory cancer pain because of drug sides effects or intractable pain. The aim of this approach is to improve pain management, and also to improve patient comfort. This study will assess patient discomfort symptoms before and after setting up intrathecal analgesia.

Detailed description: Descriptive multicenter study including patients with refractory cancer pain (unmanageable drug sides effects or intractable pain) who will receive intrathecal analgesia Patient discomfort symptoms will be evaluated before and after the beginning of intrathecal analgesia at 15, 30, 60 and 90 days.

Moreover, the impact on patient close relatives and on return home will be assessed.

Eligibility criteria: Inclusion criteria:

* patients aged 18 and older
* obligation of affiliation or beneficiary of a social security scheme
* patients with cancer and refractory localized cancer pain because of drug side effects or intractable pain
* localized pain in topography accessible to intrathecal analgesia (legs, abdomen and pelvis, pancoast-tobias symdrom)
* patient's informed consent for the study
* patient able to complete the evaluation questionnaires
* estimed vital prognosis more than three month
* patient with all conditions for intrathecal anagelsia

Exclusion criteria:

* patient with intracranial hypertension
* refusal of patient to be included in the study
* refusal of patient to receive intrathecal analgesia
* patient with many refractory pain localizations not accessible to intrathecal analgesia

Primary outcomes:
measure: Number Evaluation of Edmonton symptoms
timeFrame: up to 90 days after patient inclusion
Secondary outcomes:
measure: Autonomy assessment score for activities of daily living
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Raphael RENAMBATZ-ICHAMBE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04814823: Accuracy of Pulse Oximeters With Profound Hypoxia at Rest
Official title: Determination of SpO2 and PR Accuracy Specifications at Rest Accuracy of Pulse Oximeters With Profound Hypoxia Pulse Oximeter Accuracy Evaluation Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxia
Lead sponsor: Nihon Kohden
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Francisco
First posted: 2021-03-24
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult volunteers. At least 10 subjects will be recruited to complete the study. Of these 2 will be dark pigmented. If the number of samples is less than the required 200 or if less than 2 of dark pigment subjects successfully complete the study, subjects will be added to include 2 of dark pigmented subjects and at least 200 data points.

Brief summary: The aim of this study is to determine the accuracy of devices called pulse oximeters, which measure blood oxygen by shining light through fingers, ears or other skin, without requiring blood sampling. Study will be used with patients at rest.

Detailed description: This study is intended to evaluate performance of a new design pulse oximeter (test device) manufactured by Nihon Kohden Corporation sufficiently to support performance claims for an FDA 510K submission or ISO technical file. Specifically, SpO2 and pulse rate accuracy will be assessed for a Nihon Kohden OLV-4202 pulse oximeter with adult patients under a controlled setting of varying levels of inhaled oxygen concentration levels for patients at rest.

Eligibility criteria: Inclusion Criteria:

* Both male and female subjects who can give written informed consent
* Healthy subjects capable of undergoing controlled hypoxemia to the levels outlined in the desaturation profile
* Meeting the demographic requirements

Exclusion Criteria:

* Age below 18 or over 50
* Pregnant women
* Significant arrhythmia
* Blood pressure above 150 systolic or 90 diastolic
* Carboxyhemoglobin levels over 3%
* Subjects whom the investigator consider ineligible for the study

Primary outcomes:
measure: Accuracy of Sensor Oxygen Saturation by Arms Calculation
timeFrame: 30 seconds
Secondary outcomes:
measure: Accuracy of Sensor Pulse Rate by Arms Calculation
timeFrame: 30 seconds
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Hypoxia Research Laboratory
state: California
Study officials:
affiliation: UCSF Hypoxia Research Laboratory
name: Philip Bickler, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: