louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05309161: Efficacy Testing of Crassocephalum Rabens Extract Capsules
Official title: Efficacy Testing of Crassocephalum Rabens Extract Capsules
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Lead sponsor: Greenyn Biotechnology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Chia Nan University of Pharmacy ＆ Science
First posted: 2022-04-04
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is to investigate the improveing effects of the Crassocephalum rebens extract on skin conditions in normal people.


Eligibility criteria: Inclusion Criteria:

1. Age over 20 years
2. Healthy people

Exclusion Criteria:

1. Non-volunteer
2. Pregnant and lactating women
3. Hypersensitivity to the assigned product
4. Diagnosed with skin diseases, liver diseases, kinedy disease, and other severe diseases
5. Cosmetic, drug, or food allergies
6. Concurrent aesthetic treatments (e.g., intense pulse light, medical peelings, or laser therapy)
7. Aceepted aesthetic treatments one month ago before the study
8. Chronic sun exposure (over 3 hours/day)
9. The members of the research team

Primary outcomes:
measure: Measurement of skin hydration
timeFrame: Week 0
measure: Measurement of skin hydration
timeFrame: Week 4
measure: Measurement of skin brightness
timeFrame: Week 0
measure: Measurement of skin brightness
timeFrame: Week 4
measure: Measurement of skin texture
timeFrame: Week 0
measure: Measurement of skin texture
timeFrame: Week 4
measure: Measurement of skin spots
timeFrame: Week 0
measure: Measurement of skin spots
timeFrame: Week 4
measure: Measurement of collagen content
timeFrame: Week 0
measure: Measurement of collagen content
timeFrame: Week 4
measure: Measurement of Crow's feet
timeFrame: Week 0
measure: Measurement of Crow's feet
timeFrame: Week 4
measure: Measurement of skin elasticity
timeFrame: Week 0
measure: Measurement of skin elasticity
timeFrame: Week 4
measure: Measurement of skin wrinkles
timeFrame: Week 0
measure: Measurement of skin wrinkles
timeFrame: Weeks 4
measure: Measurement of skin pores
timeFrame: Week 0
measure: Measurement of skin pores
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Chia Nan University of Pharmacy ＆ Science
Study officials:
affiliation: Department of Cosmetic Science, Chia Nan University of Pharmacy ＆ Science
name: Chia-Hua Liang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02858661: Improving the Diagnosis of Meningitis in Emergency Rooms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meningitis
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 109
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of meningitis caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC diarrhoea tests . This lab has discovered over 200 new species of bacteria in humans, including vector bacteria and opened the field of large Deoxyribonucleic Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribonucleic Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens described in POC laboratory, this study proposes to expand the etiological diagnosis strategy of meningitis after POC test.


Eligibility criteria: Inclusion Criteria:

* Patient admitted at hospital for meningitis requiring, for the emergency physician, a microbiological examination with a "POC meningitis kit."
* Patient who has freely signed the informed written consent
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Pregnant woman, parturient or nursing
* Adult patient under guardianship
* Patient deprived of liberty under court order
* Patient refusing or unable to sign the informed consent form.

Primary outcomes:
measure: Percentage of patients admitted with a meningitis with a confirmed etiological diagnosis
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hopitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: Catherine GEINDRE
role: STUDY_DIRECTOR
References:
Clinical trial NCT06771661: Parents' Experience of Child Loss During Pregnancy or Birth
Official title: Parents' Experience of Child Loss During Pregnancy or Birth - an Explorative, Sequential Mixed-methods Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stillbirth and Fetal Death
Miscarriages
Experience
Keywords: Pregnancy loss
Child loss
Qualitative research
Mixed-methods
Experience
Need
Parents
Perinatal loss
Fetal death
Miscarriage
Stillbirth
Lead sponsor: Deggendorf Institute of Technology, Faculty of Applied Healthcare Sciences
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Parents (mothers, fathers) will be recruited that lost their child during pregnancy or birth in hospitals, at home or birth houses.

Brief summary: The investigators are conducting a participatory study with and for parents after child loss during pregnancy or birth. Their aim is to develop treatment recommendations for healthcare professional. These focus on question, how to deal with parents when experiencing child loss.

Detailed description: The entire study is following a participatory approach and including parents after stillbirth in the research team. Along a co-creative design, the investigators planned a multistep-explorative mixed-methods study.

In detail, three key steps will be conducted. First, workshops and focus groups will be carried out to identify central needs of affected parents. Afterwards, one investigator will interview the parents narratively to gain an in-depth understanding of their experiencs. Finally, these findings will be summarized and translated into treatment recommendations for healthcare professionals.

Eligibility criteria: Inclusion Criteria:

* German speaking
* Living in Austria, Germany or Switzerland
* Child loss during pregnancy or birth
* Child loss within last 12 months
* Legal capacity
* Voluntary participation

Exclusion Criteria:

* Loss of child after birth
* Not speaking and understanding German
* Not in a good mental condition to participate

Primary outcomes:
measure: Parent's experience
timeFrame: During pregnancy and up to 7 days after birth
Secondary outcomes:
measure: Parents' subjective needs
timeFrame: During pregnancy and up to 7 days after birth
Other outcomes:
Locations:
city: Deggendorf
country: Germany
facility: Deggendorf Institute of Technology, Faculty of Applied Healthcare Sciences
state: Bavaria
Study officials:
affiliation: Deggendorf Institute of Technology
name: Christian Rester, Prof. Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT03288961: Self Screening Tool for Crohn's Perianal Fistula
Official title: Development and Validation of Patient Self-screening and Monitoring Tool for Crohn's Perianal Fistula
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crohn Disease
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2017-09-20
Enrollment: 146
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Crohn's disease patients are asked to fill out survey of their perianal symptoms. Survey score is compared with MRI results as the gold standard.

Brief summary: This study aims to develop a self-screening tool for Crohn's perianal fistula.


Eligibility criteria: Inclusion Criteria:

* Crohn's disease

Exclusion Criteria:

-

Primary outcomes:
measure: Perianal fistula
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
Study officials:
References:
Clinical trial NCT05080361: Rechallenge of BRAF +/- MEK Inhibitors Following an Adverse Event in Patients With Cancer
Official title: Rechallenge of Rapidly Accelerated Fibrosarcoma B-type (BRAF) +/- Mitogen-activated Extracellular Signal-regulated Kinase (MEK) Inhibitors Following an Adverse Event in Patients With Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Lead sponsor: University Hospital, Caen
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 16000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population is made of individual case safety reports from the World Health Organization pharmacovigilance database VigiBase, where patients had an adverse event following BRAF+/-MEKi therapy intakes.

Brief summary: Very little data are published on the safety of a rechallenge with a BRAF inhibitor or combination of BRAF and MEK inhibitor (BRAFi and MEKi) after an adverse event (AE). This study aimed at identifying the recurrence rate of the same AE after a BRAFi +/- MEKi rechallenge in patients with cancer and the factors associated to the recurrence.

Detailed description: This is an observational, cross-sectional, pharmacovigilance cohort study. AEs were extracted from safety reports from the World Health Organization database VigiBase®, to evaluate the safety of a rechallenge with a BRAF inhibitor or combination of BRAF and MEK inhibitor (BRAFi and MEKi) after an adverse event (AE) in patients with cancer.

Eligibility criteria: Inclusion Criteria:

* All consecutive AE cases associated with BRAFi and MEKi therapy. Combination therapy cases, where BRAFi were concurrently reported with MEKi will be identified, as well as the combination therapy regimen (V+C, D+T, E+B). We will not study MEKi monotherapy cases

Exclusion Criteria:

* MEKi monotherapy cases
* Cases concurrently reporting on immune checkpoint inhibitor therapies

Primary outcomes:
measure: Recurrence rate
timeFrame: Up to the date of the individual case safety report notification in VigiBase(r), assessed up to 10 years
Secondary outcomes:
measure: Comparison of rechallenge and non-rechallenge cases
timeFrame: Up to 10 years
measure: Factors associated with the recurrence after a rechallenge among informative rechallenges (i.e. variables associated with a higher recurrence rate, in a regression model)
timeFrame: Up to 10 years
measure: Rate of occurrence of a different AE after a monotherapy or combination therapy rechallenge (among informative rechallenges)
timeFrame: Up to the date of the individual case safety report notification in VigiBase(r), assessed up to 10 years
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Caen
name: Charles Dolladille
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06711861: Multicenter Retrospective Study on Streptobacillus Moniliformis Infections in France
Official title: Multicenter Retrospective Study on Streptobacillus Moniliformis Infections in France
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Streptobacillus Moniliformis Infections
Keywords: Streptobacillus moniliformis
Zoonosis
Rat bites
Zoonotic diseases
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-12-02
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient having Streptobacillus moniliformis infection between 01/01/2007 and 31/12/2023

Brief summary: French data on Streptobacillus moniliformis infections (zoonosis transmitted by rat bites) are rare and there are no case series in the literature to date. This is a pathology presenting atypical clinical manifestations for a bacterial infection and which therefore remains underdiagnosed. Streptobacillus moniliformis infections can be fatal without appropriate antibiotic treatment. This study could improve diagnosis, develop early treatment strategies and contribute to the overall understanding of zoonotic diseases


Eligibility criteria: Inclusion Criteria:

* Minor patient aged 1 to 17 years
* Adult patient ≥18 years
* Proven Streptobacillus moniliformis infection between 01/01/2007 and 31/12/2023
* Subject not objecting, after being informed, to the reuse of their data for the purposes of this research
* Holders of parental authority not objecting, after being informed, to the reuse of their data for the purposes of this research their child for the purposes of this research

Exclusion Criteria:

* Subject and/or holder of parental authority having expressed opposition to participating in the study

Primary outcomes:
measure: Retrospective study of the effectiveness of antibiotic therapy initiated for the treatment of Streptobacillus moniliformis infection.
timeFrame: Negative blood culture 15 days after the start of antibiotic therapy.
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service des Maladies Infectieuses et Tropicales - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT04491461: Acute Effects of an Herbal Tea on Immune Surveillance and Activation.
Official title: Acute Effects of an Herbal Tea Blend on Immune Surveillance and Activation Status of Natural Killer Cells.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Active Immune Response
Lead sponsor: Natural Immune Systems Inc
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study uses a randomized double-blinded controlled cross-over study design.
Primary purpose: BASIC_SCIENCE

Brief summary: A small cross-over trial on 24 people involving an herbal tea blend to test whether consuming 1 cup of tea triggers changes in the numbers of natural killer cells in the blood circulation as evidence of immune cell trafficking within 2 hours.

Detailed description: A randomized, cross-over, controlled study design will be used to evaluate the effects of consumption of 1 cup of an herbal tea blend to consumption of the same volume of warm water. The study is of 3 weeks' duration, with evaluation of the herbal tea blend versus warm water at week 1 and week 2 with a one week washout between visits. On each visit, a baseline blood draw is performed, followed by consuming of the herbal tea blend or warm water. Blood draws are performed at 1 and 2 hours after consumption.

Eligibility criteria: Inclusion Criteria:

* Healthy adults;
* Age 18-75 years (inclusive);
* Veins easy to see in both arms (to allow for the multiple blood draws);
* Willing to comply with a 24-hour wash-out period for vitamins and nutritional supplements;

Exclusion Criteria:

* Previous major gastrointestinal surgery (absorption of test product may be altered) (minor surgery not a problem, including previous removal of appendix and gall bladder);
* Taking anti-inflammatory medications on a daily basis;
* Currently experiencing intense stressful events/ life changes;
* Currently in intensive athletic training (such as marathon runners);
* Currently taking antipsychotic medications such as clozapine, Risperdal, Abilify, Zyprexa or Seroquel;
* Actively depressed;
* An unusual sleep routine (examples: working graveyard shift, irregular routine with frequent late nights, studying, partying);
* Unwilling to maintain a constant intake of supplements over the duration of the study;
* Anxiety about having blood drawn;
* Women of childbearing potential: Pregnant, nursing, or trying to become pregnant;
* Known food allergies related to ingredients in active test product.

Primary outcomes:
measure: Change to natural killer cell numbers in blood circulation
timeFrame: Changes at 1 and 2 hours after consumption
Secondary outcomes:
measure: Change to natural killer cell activation status
timeFrame: Changes at 1 and 2 hours after consumption
Other outcomes:
Locations:
city: Klamath Falls
country: United States
facility: Gitte Jensen
state: Oregon
Study officials:
affiliation: NIS Labs
name: GITTE JENSEN
role: STUDY_DIRECTOR
References:
Clinical trial NCT01310361: Once-daily Therapy for Streptococcal Pharyngitis
Official title: Once-daily Therapy for Streptococcal Pharyngitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Streptococcal Sore Throat
Keywords: Pharyngitis
Group A β-hemolytic Streptococci
Exudate
Erythema Penicillin
Amoxicillin
Lead sponsor: Azad University of Medical Sciences
Sponsor class: OTHER
First posted: 2011-03-08
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In some studies once daily amoxicillin therapy might be treatment of choice for Group A β-hemolytic Streptococcus pharyngitis in comparison with three to four times daily treatment with oral penicillin V.


Eligibility criteria: Inclusion Criteria:

Inclusion Criteria:

1. Age of 6 to 15 years old.
2. The criteria in clinical examination including objective signs (fever, Erythema or exudate of tonsils, enlarged lymph nodes) and subjective sign(sore throat). Neck tenderness, abdominal pain and pharynx petechia were also considered.
3. No antibiotic was used during the week before.
4. -Performing throat culture before the initiation of drug administration
5. Positive throat culture indication GABHS
6. No previous history of allergy to penicillin .

Exclusion Criteria:

1. Age of below 6 years old or above 15 years old.
2. No signs of pharyngitis in the clinical examination
3. Antibiotic use during the week before.
4. Throat culture was not performed before the initiation of drug administration.
5. Negative throat culture or the culture indicates a microorganism other than GABHS.
6. History of allergy to penicillin
7. Not using drugs or not following the treatment in the field of having the second culture performed.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Islamic Azad University
state: Khorasan
Study officials:
References:
Clinical trial NCT00004561: Treatment of Hypertension With Two Exercise Intensities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-02-10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: To determine whether exercise training could significantly replace medication as a treatment for mild essential hypertension.

Detailed description: BACKGROUND:

Arterial hypertension affects over 50 million Americans. While drug treatment is effective, exercise would be safer, might be cheaper, and would bring added health benefits if it could replace drugs in controlling hypertension.

DESIGN NARRATIVE:

Randomized, controlled trial. Known hypertensives (n=162) whose diastolic blood pressures rose to between 90 and 104 within four months of discontinuing medication under careful observation had their pressures controlled with enalapril. Oxygen consumption (V02) peak was measured during cycle ergometry. Eligible subjects were randomly assigned to 18 months participation in one of three groups: 1) high intensity endurance training (35 minutes three times/week at heart rate at 70-85 percent of V02 peak), 2) moderate intensity endurance training (35 minutes three times/week at heart rate of 50-70 of V02 peak), and 3) contact control. Enalapril was forward or back titrated or discontinued to maintain a normal blood pressure. After 12 months participation, medication was withdrawn under careful supervision from all subjects still taking it. The trial tested the hypotheses that: 1) a greater number of subjects undergoing either or both of the two 18 month exercise training programs would be able to stop anti-hypertensive medication than non-exercising controls, 2) moderate and high intensity endurance training were equally effective in replacing drugs in the treatment of mild essential hypertension, and 3) subjects that were successful at withdrawing anti-hypertensive medication would have: greater improvements in V02 peak, better initial psychological status or greater improvements in psychological status, and greater compliance with the exercise training program.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05740761: Gene Editing as a Therapeutic Approach for Rett Syndrome
Official title: Personalized MECP2 Gene Therapy Using CRISPR/Cas9 Technology Coupled to AAV-mediated Delivery in 3D Cell Culture and KI Mice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rett Syndrome
Lead sponsor: University of Siena
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients affected by Rett syndrome with one of the four hotspots mutations in MECP2 gene: p.T158M, p.R255X, p.R168X, p.R306C

Brief summary: We designed the project to validate CRISPR/Cas9-based gene editing combined with AAV-based delivery for correction of the most common MECP2 mutations both in vitro and in vivo.

Detailed description: The project aims to validate CRISPR/Cas9-based gene editing combined with AAV-based delivery for correction of the most common MECP2 mutations both in vitro and in vivo. The laboratory of the principal investigator is an active member of the European Reference Network for rare malformation syndromes and rare intellectual and neurodevelopmental disorders (ERN-ITHACA).

Eligibility criteria: Inclusion Criteria:

* Patients -exclusively female- since the pathology is linked to the X chromosome, with a clinical diagnosis of Rett syndrome confirmed at the genetic level by the identification, through NGS analysis, for one of the recurrent mutations (mutational hotspots) in the MECP2 gene object of the study:

  c. 473C\>T - (p.(T158M)), c.502C\>T (p(R168X)), c.763C\>T (p.(R255X)), c.916C\>T (p.(R306C));
* Age above 6 months;
* Availability of parents or legal guardians to provide free and informed consent to participate in the study

Exclusion Criteria:

* NGS diagnosis with the normal outcome;
* Positive NGS diagnosis for mutation in MECP2 but with the presence of a mutation different from those under study.
* Unwillingness of parents or legal guardians to provide free and informed consent to participate in the study;

Primary outcomes:
measure: Editing efficiency
timeFrame: 3 years
Secondary outcomes:
measure: Editing specificity
timeFrame: 3 years
Other outcomes:
Locations:
city: Siena
country: Italy
facility: University of Siena
Study officials:
References: