louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01558388: Probiotic Versus Placebo as Adjuvant for Bacterial Vaginosis Treatment During Pregnancy
Official title: Randomised Control Trial of Probiotics Versus Placebo as Adjuvant to Oral Clindamycin Treatment for Bacterial Vaginosis During Pregnancy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bacterial Vaginosis
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
Collaborators: name: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
First posted: 2012-03-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Bacterial vaginosis is a common vaginal condition involving a reduction in the amount of Lactobacilli, the normal bacteria colonizing the vagina, and an overgrowth of pathogenic bacteria. The presence of bacterial vaginosis in pregnancy is associated with an increased risk of preterm delivery. After a course of antibiotic treatment, recurrence of bacterial vaginosis has been reported in 10-70% of cases. This study aims to verify if administration of vaginal Lactobacilli may reduce the occurrence rate after antibiotic treatment of bacterial vaginosis during pregnancy.


Eligibility criteria: Inclusion Criteria:

* singleton pregnancy
* gestational age 12-32 weeks
* diagnosis of bacterial vaginosis
* treatment of bacterial vaginosis with oral clindamycin 300 mg, twice-daily for 7 days

Exclusion Criteria:

* multiple pregnancy
* allergy to clindamycin

Primary outcomes:
measure: Vaginal lactobacillus recolonization
timeFrame: 3-5 weeks
measure: Recurrence rate of bacterial vaginosis
timeFrame: 3-5 weeks
Secondary outcomes:
measure: Preterm delivery <37 weeks
timeFrame: within 43 weeks of gestation
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Ostetricia 1, Azienda Ospedaliera Spedali Civili di Brescia
Study officials:
affiliation: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
name: Luana Danti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Università degli Studi di Brescia
name: Andrea Lojacono, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03188588: Observance of Long Term Oxygen Therapy in Chronic Inspiratory Disease Patients
Official title: Observance of Long Term Oxygen Therapy in Chronic Inspiratory Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Respiratory Disease
Hypoxemia
Lead sponsor: SOS Oxygene Mediterranee
Sponsor class: INDUSTRY
Collaborators: name: CHU Arnaud de Villeneuve MONTPELLIER
First posted: 2017-06-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients are recruited from pneumologia unit of hospital and from private pneumologists

Brief summary: Long-term oxygen therapy (LTOT) is the reference treatment for chronic respiratory failure. This treatment is based on the principle of oxygen supplementation via a source to correct hypoxemia in patients. At present, adherence to this treatment is difficult to evaluate (reporting by patients), but the results of the literature show poor LTOT compliance. It is therefore important to accurately measure the oxygen consumption by patients and to understand the factors explaining LTOT compliance. The ultimate aim is to improve our patient management to make them more observant in order to improve the therapeutic efficacy of the treatment.


Eligibility criteria: Inclusion Criteria:

* chronic respiratory disease patients with chronic hypoxemia
* First prescribed long term oxygenotherapy

Exclusion Criteria:

* patients with NIV and CPAP
* vital pronostic \< 3 months

Primary outcomes:
measure: oxygen use
timeFrame: 6 month
Secondary outcomes:
measure: respiratory disease severity based on GOLD standards
timeFrame: baseline
measure: quality of life assessed by a questionnaire (VQ-11)
timeFrame: baseline, 3 month and 6 month
measure: precarity score assessed by a questionnaire (EPICE)
timeFrame: baseline
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHU Arnaud de Villeneuve
Study officials:
affiliation: CHU Montpellier, France
name: Arnaud Bourdin, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00888888: Colonic Resections in Patients With Suspected Appendicitis
Official title: Risk Factors for Colonic Resections in Patients With Suspected Acute Appendicitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colectomy
Appendicitis
Keywords: Acute appendicitis
Colonic diverticulitis
Colonic tumors
Colonic resections
Lead sponsor: Cirujanos la Serena
Sponsor class: OTHER
First posted: 2009-04-28
Enrollment: 87
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients submitted to appendectomy for suspected acute appendicitis and in whom the surgeon takes the decision to convert to right colectomy based on operative findings and other factors the we aim to identify

Brief summary: Although many reports have been published on colonic resections in patients with suspected appendicitis and the diseases that cause the decision to resect the colon have been identified and their proper treatments have been established, there is no report on the risk factors present in converting a simple appendectomy into a major colonic resection.

The investigators aimed to identify the risk factors that lead the surgeon to perform a colonic resection in patients undergoing surgery for initially suspected acute appendicitis.


Eligibility criteria: Inclusion Criteria:

* Patients older than 15 years of age
* Male or female
* Suspected of having acute appendicitis
* Converted to right hemicolectomy

Exclusion Criteria:

* Patients in whom a right hemicolectomy was planned initially
* Right hemicolectomy for causes other than suspected acute appendicitis

Primary outcomes:
measure: Short-term survival
timeFrame: 3 months
Secondary outcomes:
measure: Long-term survival
timeFrame: 5 years
Other outcomes:
Locations:
city: La Serena
country: Chile
facility: Hospital de La Serena
state: Iv Region
Study officials:
affiliation: Hospital de La Serena
name: MARCELO A BELTRAN, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04432688: The Safety and Effectiveness of Latuda® Post-marketing Surveillance in the Treatment of Chinese Schizophrenia Patients
Official title: The Safety and Effectiveness of Latuda® Post-marketing Surveillance in the Treatment of Chinese Schizophrenia Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Lead sponsor: Sumitomo Pharma (Suzhou) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-06-16
Enrollment: 3192
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Schizophrenia Patients who begin to receive Latuda®

Brief summary: It's a prospective, non-interventional, observational Post-marketing Surveillance..

Detailed description: It's a prospective, non-interventional, observational Post-marketing Surveillance, the aim of the surveillance is to observe the safety and overall effectiveness of Latuda® in the treatment of Chinese patients with schizophrenia for 12 weeks in real clinical practice, as well as the dose of Latuda® for monotherapy or combination therapy.

Eligibility criteria: Inclusion Criteria:

* Schizophrenia Patients who begin to receive Latuda®

Exclusion criteria:

* No exclusion criteria

Primary outcomes:
measure: The incidence of Adverse Event
timeFrame: week 12
Secondary outcomes:
measure: The incidence of extrapyramidal symptom
timeFrame: baseline/ week 2-4/ week 6-8/ week 12
measure: The incidence of akathisia
timeFrame: baseline/ week 2-4/ week 6-8/ week 12
measure: the rate of use of extrapyramidal symptom treatment drugs
timeFrame: baseline/ week 2-4/ week 6-8/ week 12
measure: Changes in body weight at the end of treatment compared with baseline
timeFrame: baseline/ week 12
measure: The overall Brief Psychiatric Rating Scale (BPRS) score change at the end of the treatment compared with the baseline
timeFrame: baseline/ week 2-4/ week 6-8/ week 12
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anding Hospital
state: Beijing
city: Harbin
country: China
facility: The first specialized hospital of Harbin
state: Heilongjiang
city: Changsha
country: China
facility: Brain Hospital of Hunan Province
state: Hunan
city: Jinan
country: China
facility: Shandong Mental Health Center
state: Shandong
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
city: Taiyuan
country: China
facility: First Affiliated Hospital of Shanxi Medical University
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Anding Hospital
state: Tianjin
Study officials:
affiliation: Shanghai Mental Health Center
name: Yifeng Xu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05546788: Hydroxylated Polymethoxy Flavones Solid Dispersion in Treatment of Periodontitis
Official title: The Effectiveness of Hydroxylated Polymethoxy Flavones Solid Dispersion Incorporated Sodium Carboxymethyl Cellulose Gel With Periodontal Debridement in the Treatment of Periodontitis. Clinical- Biochemical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Inflammatory Disease
Periodontal Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups of patients with periodontitis, Group I received plain gel Group II received chlorhexidine gel Group III received hydroxylated polymethoxy flavones solid dispersion gel
Primary purpose: TREATMENT

Brief summary: Periodontitis is a serious gum infection that damages the soft tissue and, without treatment, can destroy the bone that supports your teeth.

Hydroxylated poly methoxy flavones are a combination of naturally occurring flavonoids extracted from the orange peel and exert anti-inflammatory, antibacterial, and antifungal activity however, this extract is poorly soluble and poorly absorbable. In this work, this extract was formulated as a solid dispersion formulation to enhance its biological activity and then incorporated into a gel base and used in the treatment of periodontitis after clinical debridement.

Detailed description: In the study, there are 3 groups; the first one first one received plain sodium carboxymethylcellulose. Group II received chlorhexidine gel. GroupIII received Hydroxylated poly methoxy flavones solid dispersion incorporated into sodium carboxymethylcellulose gel.

In all groups, there is clinical debridement before injection of gels.

Eligibility criteria: Inclusion Criteria:

* Patients with periodontitis stage I-II
* free from any systemic disorders.
* no mobility - non-smokers - no parafunctional habits.
* Each patient with minimum three periodontitis sites ( split-mouth study)

Exclusion Criteria:

* Smokers.
* patients with diabetes, and hypertension.

Primary outcomes:
measure: Clinical attachment loss will be quantified in centimeters before and after treatment
timeFrame: One week
measure: Pocket Depth will be quantified in centimeters before and after treatment
timeFrame: One week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04926909: Study on Serum Cystatin C and PET-DAT in Patients With Parkinson's Disease
Official title: The Relationship Between Serum Cystatin C and PET-DAT Study in Patients With Parkinson's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parkinson's Disease
Keywords: Cystatin C, PET-DAT
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-15
Enrollment: 121
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Pearson correlation analysis is planned, and the sample size is calculated with PASS 15.0 software. 121 participants required after sample size calculation. The calculation parameters are as follows: Power = 0.90, α=0.05, ρ0 = 0.0, and ρ1 = 0.3.

Brief summary: To investigate the relationship between serum cystatin C and dopamine receptor(DAT) loss in patients with parkinson's disease(PD)

Detailed description: Number of people suffered from Parkinson disease (PD) is increasing every year. PET imaging of dopamine transport receptors（DAT） serves as the gold standard for the diagnosis and monitoring of PD development. However, due to high costs and radiation reasons, it is not suitable for long-term follow-up. Serum cystatin C can be easily obtained and cheap as an indicator. In recent years, studies have gradually found that it is related to the progression of H\&Y staging of Parkinson's disease. To this extent, we want to further explore whether it can reflect the loss of DAT in the brain. Explore whether it can partially replace the role of DAT imaging for future clinical evaluation.

Eligibility criteria: Inclusion Criteria:

* Patients aged between 20 and 80 years and whose laboratory results included the levels of serum Cystatin C within a month from the PET-DAT were recruited.

Exclusion Criteria:

* To make the study cohort more homogeneous, PD patients with either a long-standing duration (≥5 years) or advanced Hoehn and Yahr (H\&Y) staging (≥3) were excluded.

Primary outcomes:
measure: Cystatin C assesses the loss of dopaminergic neurons
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, College of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References:
Clinical trial NCT02551809: Evaluate the Safety, Tolerability, Immunogenicity and Efficacy of UB-311 in Mild Alzheimer's Disease (AD) Patients
Official title: A Randomized, Double-blind, Placebo-controlled, 3-arm Parallel-group, Multicenter, Phase IIa Study to Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of UBITh® AD Immunotherapeutic Vaccine (UB-311) in Patients With Mild Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Lead sponsor: United Neuroscience Ltd.
Sponsor class: INDUSTRY
First posted: 2015-09-16
Enrollment: 43
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this Phase IIa study is to determine whether the AD Immunotherapeutic Vaccine (UB-311), targeting the amyloid beta peptide (N-terminal amino acids, 1-14), is safe and immunogenic in mild AD patients. In addition, the efficacy profiles will be evaluated as the secondary endpoint.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of mild Alzheimer's Disease
* Mini-Mental State Examination (MMSE) scores between 20 and 26 (inclusive)
* Clinical dementia rating (CDR) scores of 0.5 or 1
* Other inclusion criteria apply

Exclusion Criteria:

* Clinically significant neurological disease other than Alzheimer's disease
* Major psychiatric disorder
* Severe systemic disease
* Serious adverse reactions to any vaccine
* Other exclusion criteria apply

Primary outcomes:
measure: Tolerability and Safety Profile of UB-311 Assessed Via Recording of Number of Participants With Adverse Events
timeFrame: 78 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital (KS-CGMH)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital (NTUH)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital (TVGH)
city: Taoyuan
country: Taiwan
facility: Linkou Chang Gung Memorial Hospital (LK-CGMH)
Study officials:
References:
citation: Wang CY, Wang PN, Chiu MJ, Finstad CL, Lin F, Lynn S, Tai YH, De Fang X, Zhao K, Hung CH, Tseng Y, Peng WJ, Wang J, Yu CC, Kuo BS, Frohna PA. UB-311, a novel UBITh(R) amyloid beta peptide vaccine for mild Alzheimer's disease. Alzheimers Dement (N Y). 2017 Apr 14;3(2):262-272. doi: 10.1016/j.trci.2017.03.005. eCollection 2017 Jun.
Clinical trial NCT05678309: Establishment of a Patient Library in Patients With Pruritus Sine Materia
Official title: Establishment of a Patient Library in Patients With Pruritus Sine Materia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pruritus
Chronic Pruritus
Itch
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with pruritus sine materia

Brief summary: Very little is currently known about the pathophysiology of pruritus sine materia according to the etiology. The creation of this cohort should make it possible to improve our clinical and biological knowledge according to the etiology, by collecting blood, skin, feces, and clinical data.

Detailed description: At inclusion, 52.5 ml of blood will be collected, then an additional skin biopsy and a skin swab. Five questionnaires will be filled in by the patient.

At 6 months, then every years for 5 years, the same 5 questionnaires will be collected as well as the clinical data. However, no more biological samples will be collected.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of pruritus sine materia
* Collection of consent
* Adult

Exclusion Criteria:

- Refusal to participate in the study

Primary outcomes:
measure: Clinical description of the pruritus
timeFrame: 5 years
measure: Clinical description of the pruritus
timeFrame: 5 years
measure: Clinical description of the pruritus
timeFrame: 5 years
measure: Clinical description of the pruritus
timeFrame: 5 years
measure: Clinical description of the pruritus
timeFrame: 5 years
measure: Clinical description of the pruritus
timeFrame: 5 years
measure: Clinical description of the pruritus
timeFrame: 5 years
measure: 5-D itch scale questionnaire
timeFrame: 5 years
measure: Dermatology Life Quality Index questionnaire (DLQI)
timeFrame: 5 years
measure: Hospital anxiety and depression questionnaire (HAD)
timeFrame: 5 years
measure: Brest Questionnaire
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Service de dermatologie, CHRU BREST
Study officials:
References:
Clinical trial NCT06458309: Mangement of Spine Fracture
Official title: Management of Spine Fractures According to The Thoracolumbar AO Spine Injury Score
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Spine Fracture
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Each year, there are approximately 5 million new vertebral fractures worldwide1. Most of these fractures involve the thoracolumbar or lumbar spines. The thoracolumbar junction, due to its mechanical transition zone, and the lumbar spine, due to its absence of stabilizing articulations with the ribs, lordotic posture and more sagittal oriented facet joints, are vulnerable for involvement in spinal injuries2.

Burst fractures occurs frequently in high-energy traumas which are most commonly associated with falls and traffic accidents.3


Eligibility criteria: Inclusion Criteria:

* 1-Skeletally mature patients (18yrs and older). 2-Thoracolumbar fractures.

Exclusion Criteria:

* 1-skeletally immature patients. 2-pathological fractures.

Primary outcomes:
measure: AO Spine Injury Score
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
citation: Hu R, Mustard CA, Burns C. Epidemiology of incident spinal fracture in a complete population. Spine (Phila Pa 1976). 1996 Feb 15;21(4):492-9. doi: 10.1097/00007632-199602150-00016.
citation: Tran NT, Watson NA, Tencer AF, Ching RP, Anderson PA. Mechanism of the burst fracture in the thoracolumbar spine. The effect of loading rate. Spine (Phila Pa 1976). 1995 Sep 15;20(18):1984-8. doi: 10.1097/00007632-199509150-00004.
citation: Bohlman HH. Treatment of fractures and dislocations of the thoracic and lumbar spine. J Bone Joint Surg Am. 1985 Jan;67(1):165-9. No abstract available.
citation: McAfee PC, Yuan HA, Fredrickson BE, Lubicky JP. The value of computed tomography in thoracolumbar fractures. An analysis of one hundred consecutive cases and a new classification. J Bone Joint Surg Am. 1983 Apr;65(4):461-73.