louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06821789: Effects of Lacticaseibacillus Rhamnosus LRa05 on Bacterial Vaginosis and Ovarian Function in Women
Official title: Effects of Lacticaseibacillus Rhamnosus LRa05 on Bacterial Vaginosis and Ovarian Function in Women: a Randomized, Double-blind, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Patients With Bacterial Vaginosis
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-02-12
Enrollment: 60
Sex: FEMALE
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: In this study, Lacticaseibacillus rhamnosus LRa05 was selected as test preparations to observe the clinical efficacy in the intervention trial of combined antibiotic therapy, and to evaluate its effects on the cure rate, recurrence rate and vaginal microbiota of patients with bacterial vaginitis.


Eligibility criteria: Inclusion Criteria:

1. 18 to 65 years old, sexual activity, premenopausal women;
2. Nugent score for diagnosing BV ≥7;
3. Signed informed consent.

Exclusion Criteria:

1. Mixed vaginitis, such as vulvovaginal candidiasis (VVC), Trichomonas vaginalis (TV) infection, Chlamydia trachomatis (CT) infection or gonococcal vaginitis;
2. history of systemic organic disease or psychiatric illness;
3. Planning pregnancy, breastfeeding, menstruation;
4. within 5 days of the onset of the disease, any antibiotics have been used;
5. long-term use of contraceptives or immunosuppressants;
6. Allergic constitution or hypersensitivity to known components of the study drug.

Primary outcomes:
measure: Cure rate of bacterial vaginosis
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02963389: A Study to Evaluate Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Tripegfilgrastim in Pediatric Solid Tumor/Lymphoma Patients
Official title: A Phase I Clinical Trial to Investigate the Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Tripegfilgrastim After Single Administration in Pediatric Solid Tumor/Lymphoma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Lymphoma
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-11-15
Enrollment: 27
Sex: ALL
Minimum age (years): 6
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is an open-label, single ascending dose study to evaluate safety, tolerability, and pharmacokinetics/pharmacodynamics of Tripegfilgrastim in pediatric solid tumor/lymphoma patients


Eligibility criteria: Inclusion Criteria:

* \>=6 and \<19-year-old pediatrics with solid tumor/lymphoma
* Scheduled for chemotherapy requiring G-CSF support or having given an experience of ANC \< 0.5x10\^9/L
* ANC \> 0.75x10\^9/L, platelet \> 75x10\^9/L
* ECOG performance status 0 or 1

Exclusion Criteria:

* Patients with leukemia, myelodysplastic syndrome or uncontrolled infectious/nervous diseases
* History of allergy to filgrastim, pegfilgrastim or known hypersensitivity to E-coli derived proteins.
* Women who are pregnant or lactating

Primary outcomes:
measure: PK parameter
timeFrame: Day 1(Hour 0) ~ Day 21
measure: PK parameter
timeFrame: Day 1(Hour 0) ~ Day 21
measure: PK parameter
timeFrame: Day 1(Hour 0) ~ Day 21
measure: PK parameter
timeFrame: Day 1(Hour 0) ~ Day 21
measure: PK parameter
timeFrame: Day 1(Hour 0) ~ Day 21
Secondary outcomes:
measure: PD parameter
timeFrame: Day 1(Hour 0) ~ Day 14
measure: PD parameter
timeFrame: Day 1(Hour 0) ~ Day 14
measure: PD parameter
timeFrame: Day 1(Hour 0) ~ Day 14
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
citation: Lee S, Hong KT, Moon SJ, Choi JY, Hong CR, Shin HY, Cho JY, Jang IJ, Yu KS, Oh J, Kang HJ. Pharmacokinetic and Pharmacodynamic Characteristics of Tripegfilgrastim, a Pegylated G-CSF, in Pediatric Patients with Solid Tumors. Clin Pharmacol Ther. 2022 Jan;111(1):293-301. doi: 10.1002/cpt.2433. Epub 2021 Oct 27.
Clinical trial NCT04029389: Ultrasound-Guided Tibial Nerve Block vs. Local Corticosteroid Injection in Recalcitrant Plantar Fasciitis Treatment
Official title: Ultrasound-Guided Tibial Nerve Block vs. Local Corticosteroid Injection: A Randomized Controlled Study for Recalcitrant Plantar Fasciitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Plantar Fascitis
Tibial Nerve
Injections
Ultrasonography
Keywords: Plantar Fascitis
Tibial Nerve
Injections
Ultrasonography
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2019-07-23
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled study to search for the efficiency of tibial nerve block vs local corticosteroid injection of the plantar fascia.

Detailed description: Three groups will be formed. After ESWT therapy, if the patients still suffer from pain (\> 5 points, visual analog scale(0-10points), participants will be included in the study. One group will receive conversational therapy. Second group will be treated with local corticosteroid injection. And third group will be treated with tibial nerve block. Before-treatment, after one week, after six weeks and after 3 months evaluation of the patients will be performed.

Eligibility criteria: Inclusion Criteria:

* Recalcitrant plantar Fasciitis

Exclusion Criteria:

-

Primary outcomes:
measure: VAS-Pain
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Taksim Training and Research Hospital
state: İ̇stanbul
Study officials:
affiliation: Gaziosmanpasa Taksim Training and Research Hospital
name: Ebru Yalçınkaya
role: STUDY_DIRECTOR
References:
Clinical trial NCT01338389: Influence of Oral Treatment With Citicoline for the Prevention of Radiation Optic Neuropathy in Patients Treated for Uveal Melanomas With Proton Beam Therapy
Official title: Influence of Oral Treatment With Citicoline for the Prevention of Radiation Optic Neuropathy in Patients Treated for Uveal Melanomas With Proton Beam Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uveal Melanoma
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
Collaborators: name: DENSMORE pharmaceuticals
First posted: 2011-04-19
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Proton beam irradiation is the treatment of choice for uveal melanomas. It has favorable results in causing tumor regression while preserving the eye. Optic neuropathy has emerged consistently as an irreversible cause of visual loss in proton beam irradiated eyes. No neuroprotective strategies are available at present.

Citicoline is a choline agent precursor available as a dietary supplement. Citicoline conferred acute neuroprotection and enhanced neuroplasticity in experimental stroke models. In ophthalmology, citicoline has demonstrated a significant action in improving retinal and cortical responses in patients with optic nerve diseases (glaucoma, ischemic optic neuropathy). Citicoline also exhibits a very low toxicity profile in humans.

The purpose of the study is to demonstrate whether daily oral administration of citicoline in patients treated for uveal melanomas with proton beam therapy, prevents or delays the occurrence of radiation optic neuropathy. Changes in visual acuity, Pattern ERG and visual evoked potentials are measured. The tolerability/safety of the product is also evaluated.


Eligibility criteria: Inclusion Criteria:

* over 18 years old
* uveal melanoma with posterior marge located at less than 3 mm of optic papilla
* uveal melanoma treated with proton beam therapy with irradiation of optic head nerve
* visual acuity before proton beam therapy over 30 letters (with ETDRS test)

Exclusion Criteria:

* antecedent of acute glaucoma with angle enclosure
* antecedent of chronical glaucoma with angle aperture
* antecedent of optic neuropathy optique of congenital, ischemic, inflammatory or other origins
* antecedent of neovascular glaucoma

Primary outcomes:
measure: Occurrence and delay of occurrence of radiation optic neuropathy
timeFrame: Every 6 months
Secondary outcomes:
measure: Visual function assessment
timeFrame: Every 6 months
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de NICE
city: Nice
country: France
facility: Ophtalmology Departement, St Roch Hopital, Nice University Hospital
Study officials:
affiliation: Ophtalmology department, Nice University Hospital
name: Stéphanie BAILLIF-GOSTOLI, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04425889: COVID-19 Antibodies Among Healthcare Workers
Official title: Prevalence of SARS-CoV-2 Antibodies Among Healthcare Workers in a COVID-19 Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
SARS-CoV 2
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthcare workes of any category that are 18 years of age or older, who work in the COVID-19 unit at the University Hospital and hve been diagnosing and treating suspected or confirmed cases of COVID-19

Brief summary: Observational, point of prevalence study determining the presence of anti-SARS-CoV-2 antibody

Detailed description: All Healthcare workers (HCW) who had entered contaminated areas at least once and that 14 days or more had passed from their first entrance to contaminated areas were included. They were classified as asymptomatic and pauci-symptomatic. A COVID-19 IgG/IgM rapid test was used for antibody detection, and selected participants were subject to real time polymerase chain reaction (qPCR) for SARS-CoV-2.

Eligibility criteria: Inclusion Criteria:

* All healthcare workers who had entered contaminated areas at least once and that 14 days or more had passed from their first entrance were included

Exclusion Criteria:

* Healthcare workers who did not have exposure for more or equal 14 days
* Healthcare workers who did not wish to participate

Primary outcomes:
measure: Presence of antibody
timeFrame: through study completion, an average of 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario José E. Gonzalez
state: Nuevo Leon
Study officials:
References:
Clinical trial NCT01667289: Radiotherapy Alone Versus Concurrent Chemoradiation in Low Risk NK/T-cell Lymphoma
Official title: A Randomized Phase II Study of Comparing Radiotherapy Alone With Concurrent Chemoradiation in Patients With Low Risk NK/T-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Extranodal NK/T-cell Lymphoma, Nasal Type
Keywords: NK/T-cell lymphoma
Methotrexate
Radiotherapy
Concurrent chemoradiation
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2012-08-17
Enrollment: 4
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: The purpose of this study is to prove the superiority of concurrent chemoradiation compared with radiotherapy alone in patients with low risk NK/T-cell lymphoma.

Detailed description: Radiotherapy alone is commonly used in NK/T-cell lymphoma without adverse risk including lymph node involvement, local invasion, B symptoms and high LDH level. Recently, methotrexate was prove to be a radiosensitizer in NK/T-cell lymphoma cells. Therefore, the investigators aim to verify the superiority and safety of weekly methotrexate in combination with radiotherapy in a randomized phase II study.

Eligibility criteria: Inclusion Criteria:

* Age range 18-75 years old
* Histological confirmed, previously untreated stage IE nasal NK/T cell lymphoma without following risk factors including local invasion, B symptoms and high LDH level
* ECOG performance status 0-1
* Life expectancy of more than 3 months
* Adequate bone marrow and organ functions

Exclusion Criteria:

* non-nasal NK/T-cell lymphoma
* Prior exposure of methotrexate
* With third space effusion
* Pregnant or lactating women
* Serious uncontrolled diseases and intercurrent infection
* History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix

Primary outcomes:
measure: 3-year Progression-free survival
timeFrame: 3 years
Secondary outcomes:
measure: Overall response rate
timeFrame: 3 years
measure: 3-year overall survival
timeFrame: 3 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Cancer Hospital
state: Shanghai
Study officials:
affiliation: Fudan University
name: Ye Guo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01149889: Transcranial Direct Current Stimulation to Treat Major Depressive Disorder
Official title: An Open-label, Crossover Study on Major Depressive Disorder Using Transcranial Direct Current Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Major Depressive Disorder
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2010-06-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators purpose is to offer active Transcranial Direct Current Stimulation (tDCS) in patients of the investigators previous study who received either placebo or sertraline and have not responded.


Eligibility criteria: Inclusion criteria:

Patients from a previous study (ID:USP-HU-001) who:

* received sertraline and did not respond.
* received placebo and did not respond.

Exclusion criteria:

Patients from a previous study who:

* received active tDCS.
* responded.

Primary outcomes:
measure: Treatment Response
timeFrame: Week 1
measure: Treatment response
timeFrame: Week 2
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Andre R Brunoni, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06884189: Application of Plant Protection Products (PPP) in Apple Orchards
Official title: Pilot Study on the Exposure of Operators, Residents and Workers to Plant Protection Products Used in Apple Orchards and Possible Health Effects
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dermal Exposure
Inhalative Exposure
Metabolites in Urine
Effekt Biomarker in Blood
Keywords: exposure study
plant protection products
human biomonitoring
effect biomarker
Lead sponsor: German Federal Institute for Risk Assessment
Sponsor class: OTHER
Collaborators: name: Federal Ministry of Food and Agriculture
name: ESTEBURG Obstbauzentrum Jork Kompetenzzentrum für den norddeutschen Obstbau
First posted: 2025-03-19
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Users, residents and workers:

people from "Altes Land", a large apple-growing region in northern Germany

Control: live at least 10 km and max. 150 km away from agricultural apple orchards

Brief summary: The aim of the aPPPle pilot study is to test feasibility and generate first results in preparation for a main study. The aPPPle study will investigate the exposure of operators, workers and residents to plant protection products (PPP) and potential physiological effects on blood biomarkers. The target plants are apple crops, as application occurs at higher altitudes and therefore higher drift/exposure is expected compared to ground-level application. The substances to be investigated are acetamiprid (an insecticide) and dithianon and dodine (two fungicides).


Eligibility criteria: Inclusion Criteria:

* belonging to one of the defined study groups
* over 18 years of age at the time of recruitment
* person can understand the language and content of the study requirements
* person is capable of consenting to participate in the study and has given written consent to participate in the aPPPle study
* person has health insurance

Exclusion Criteria for residents and control:

person has direct professional contact with the tested substances acetamiprid, dithianon or dodine

Primary outcomes:
measure: Concentration of plant protection substances/metabolites in different matrices
timeFrame: Operators: during the observed work with PPP and for urine up to 48 hours after; resident: during the observed application and for urine up to 48 hours after; workers: during work in the orchards and for urine up to 48 hours a; control: at one time point
measure: Effect biomarkers in blood and metabolome in plasma
timeFrame: enrollment until 7 days after application/work in the apple orchards; for people from the control group at one time point
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Federal Institute for Risk Assessment
Study officials:
References:
Clinical trial NCT04896489: Neuroimaging Mechanisms by Which Memory and Glucocorticoids Promote Risky Drinking
Official title: Neuroimaging Mechanisms by Which Memory and Glucocorticoids Promote Risky Drinking
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Alcohol Drinking
Drinking Behavior
Episodic Memory
Long-term Memory
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 27
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether hydrocortisone biases formation of alcohol-related memories to potentiate drinking.

Detailed description: This study aims to 1) Characterize the effect of elevated glucocorticoids during encoding on long-term memory for alcohol-related information; 2) Identify the neural mechanisms by which glucocorticoids influence encoding of alcohol-related experiences; and 3) Determine how glucocorticoid modulation of alcohol-related encoding relates to drinking after retrieving alcohol-related memories.

Eligibility criteria: Inclusion Criteria:

* Able to read and write English
* BMI 18-35
* Beer drinking

Exclusion Criteria:

* Meet current criteria for any substance use disorder, excluding caffeine
* Current significant medical conditions or psychiatric symptoms requiring medication
* Current use of medications/drugs that interfere with the HPA axis response
* Peri and post-menopausal women, pregnant or lactating women, and those with hysterectomies
* Metal in body (for MRI safety)
* Systemic fungal infections (contraindication for hydrocortisone)
* Known hypersensitivity to components of hydrocortisone tablets (hydrocortisone, calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose)

Primary outcomes:
measure: Changes fMRI signal
timeFrame: 1 hour
measure: Item memory
timeFrame: Up to 90 minutes
measure: Context memory
timeFrame: Up to 90 minutes
measure: Affect memory
timeFrame: Up to 90 minutes
Secondary outcomes:
measure: Alcohol motivation
timeFrame: 10 minutes
measure: Affect - Negative
timeFrame: 10 minutes
measure: Affect - Positive
timeFrame: 10 minutes
measure: Neuroendocrine/cortisol reactivity
timeFrame: Baseline to 2 hours
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Elizabeth V Goldfarb, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04249089: Do Relaxation Exercises Decrease Postoperative Pain After Arthroscopic Rotator Cuff Repair?
Official title: Do Relaxation Exercises Decrease Postoperative Pain After Arthroscopic Rotator Cuff Repair?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rotator Cuff Injuries
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2020-01-30
Enrollment: 151
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of relaxation exercises on pain level and pain medication use after arthroscopic rotator cuff shoulder surgery


Eligibility criteria: Inclusion Criteria:

1. Males and nonpregnant females aged 18 years or older
2. full-thickness rotator cuff tear undergoing arthroscopic rotator cuff repair surgery

Exclusion Criteria:

1. Patients with an irreparable tear, revision shoulder surgery, multiple shoulder surgeries, concomitant severe glenohumeral arthritis, concomitant adhesive capsulitis
2. worker's compensation claim
3. diagnosed psychological disorder
4. history of alcohol or drug abuse
5. patients on preoperative narcotic therapy
6. patients who already practice relaxation techniques (i.e. mindful meditation, guided imagery, breathing exercises, yoga, etc.).

Primary outcomes:
measure: Opioid Consumption
timeFrame: From surgery to 5 days after surgery
measure: Post-operative pain
timeFrame: From surgeyr to 5 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Egg Harbor Township
country: United States
facility: Rothman Orthopaedic Institute
state: New Jersey
Study officials:
References:
citation: Weekes DG, Campbell RE, Wicks ED, Hadley CJ, Chaudhry ZS, Carter AH, Pepe MD, Tucker BS, Freedman KB, Tjoumakaris FP. Do Relaxation Exercises Decrease Pain After Arthroscopic Rotator Cuff Repair? A Randomized Controlled Trial. Clin Orthop Relat Res. 2021 May 1;479(5):870-884. doi: 10.1097/CORR.0000000000001723.