louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06738342: Clinical Efficacy of a Chlorhexidine-based Mouth-rinse Containing Citrus Aurantium Amara
Official title: Clinical Efficacy of a Chlorhexidine-based Mouth-rinse Containing Citrus Aurantium Amara in Patients Undergoing Periodontal Surgery: a Triple-blind, Parallel-arm, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Wound Healing
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The primary objective of the study is the evaluation of efficacy of a mouthwash cointaining Chlorexidine (CHX) 0.09% + HA + Citrox (test group) on the quality of wound healing and the presence plaque formation and gingival inflammation in the post-surgical phase. Futhermore stains, discolorations and adverse effects will be eventually recorded. Control group will be represented by the use of a CHX 0.12% mouthwash.


Eligibility criteria: Inclusion Criteria:

* More than 20 natural teeth excluding the third molars
* Clinical indication for a surgical intervention for the treatment of at least one residual pocket after non-surgical therapy (pocket depth (PD) ≥5mm)
* Have a full mouth plaque score (FMPS) \<15% before surgery;
* Have a full mouth bleeding score (FMBS) \<15% before surgery;
* Ability and willingness to give written informed consent;
* Written agreement to participate in the trial.

Exclusion Criteria:

* Use of medications, such as anti-platelet or anti-coagulant agents, any other concomitant systemic disorder, cardiovascular and diabetes diseases, allergic, infectious diseases and medications affecting periodontal inflammation
* Pregnancy or breastfeeding;
* Use of medication affecting the healing process;
* Assumption of systemic or local antibiotics in the 4 weeks before trial beginning;
* Conditions of the teeth or of the site that contraindicate the surgery (severe mobility, fractures, untreated endodontic lesions, incongruous restorations);
* Patients with previous periodontal treatment or who were undergoing a course of dental or orthodontic treatment will be also excluded.
* Tobacco use (10 or more cigarettes per day)
* Inability to comply with protocol
* Uncooperative patient

Primary outcomes:
measure: Oedema
timeFrame: 1, 3, 7 an 14 days
Secondary outcomes:
measure: Early Healing Score
timeFrame: 24 hours post surgery, 3, 7 and 45 days post surgery
measure: Plaque Index modified by Turesky
timeFrame: 1,3,7 and 14 days post surgery
measure: Gingival Index modified by Trombelli
timeFrame: 1,3,7 and 14 days post surgery
measure: Lobene Index modified
timeFrame: 1,3,7 and 14 days post surgery
measure: Adverse effects
timeFrame: 1,3,7 and 14 days post surgery
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Sapienza University of Rome
Study officials:
References:
Clinical trial NCT02974842: Pre-Salpingo-Oophorectomy Pilot Study of MAKO 7 Device Performance
Official title: Cytological Evaluation of Specimens Collected With the MAKO 7 Device in Pre Salpingo-Oophorectomy Subjects for Determination and/or Differentiation of Normal Versus Atypical Versus Malignant Cells
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: BRCA1 Mutation
BRCA2 Mutation
Atypia Suspicious for Malignancy
Lead sponsor: nVision Medical
Sponsor class: INDUSTRY
First posted: 2016-11-29
Enrollment: 50
Sex: FEMALE
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: Women with pelvic mass suspicious for malignancy or have BRCA1 or BRCA2 mutations that put them at high risk of developing malignancy.

Brief summary: This study evaluates the ability of the MAKO 7 device to collect various cells

Detailed description: Prospective, multi-center observational study to evaluate the ability of the MAKO 7 device to collect cells from the fallopian tubes for cytological evaluation for determination and/or differentiation of normal versus atypical versus malignant cells.

Eligibility criteria: Inclusion Criteria:

1. Subject is medically cleared for surgery
2. Subject is scheduled to undergo a salpingo-oophorectomy for a pelvic mass suspicious for malignancy or for BRCA1 or BRCA2 mutations
3. Subject must be 18 years of age
4. Subject must be able to provide informed consent

Exclusion Criteria:

1. Contraindication to hysteroscopy
2. Acute pelvic inflammatory disease
3. Active or recent lower pelvic infection
4. Pregnancy
5. Delivery or termination of a pregnancy in the past 6 weeks
6. Known tubal obstruction including tubal ligation
7. Invasive carcinoma of the cervix or endometrium
8. Intolerance of anesthesia

Primary outcomes:
measure: Concordance Between Cytological Findings From Fallopian Tubes to Surgical Histology Results.
timeFrame: Up to 60 days post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Kaiser Permanente
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente
state: California
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: nVision Medical Corp
name: Surbhi Sarna, B.S.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02634242: Study on the Antiaging Effect of Chinese Herb Drink
Official title: Study on the Antiaging Effect of Chinese Herb Drink
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gynecological Disorders
Keywords: Si Wu Tang
antioxidation
anthropometric measurements
liver
skin
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2015-12-18
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of the current study was to check the physiological improvement of SWT on liver and skin and also the antioxidation in healthy adults.

Detailed description: Background: Si-Wu-Tang (SWT) is a well-known traditional Chinese medicine (TCM) and widely used for treating various gynecological disorders. The purpose of the current study was to check the physiological improvement of SWT on liver and skin and also the antioxidation in healthy adults.

Methods: Sixty healthy voluntary subjects were recruited and assigned into two groups, who drank 125 mL of placebo (n=30) or SWT (n=30) for 6 continuous days per month during the following 6 months and vice versa with one month of washout period in between. During the initial, 3rd, 6th, 10th, and 13th months anthropometric measurements were performed as well as fasting blood samples were drawn for various biochemical assays. Abdominal ultrasonic and skin examination were performed at the initial, 6th and 13th months.

Eligibility criteria: Inclusion Criteria:

* healthy adults

Exclusion Criteria:

* exclusion criteria were history of smoking, alcoholism
* pregnant or lactating women,
* chronic diseases, hepatic or renal dysfunction.

Primary outcomes:
measure: Total thiobarbituric acid reactive substances (TBARS)
timeFrame: 6 months
Secondary outcomes:
measure: Glutathione content (GSH)
timeFrame: 6 months
measure: Total antioxidant capacity (TEAC)activities.
timeFrame: 6 months
measure: Superoxide dismutase (SOD) activity
timeFrame: 6 months
measure: GPx and glutathione reductase (GR) activity
timeFrame: 6 months
measure: Catalase
timeFrame: 6 months
measure: Glutamic oxaloacetic transaminase (GOT)
timeFrame: 6 months
measure: Glutamic pyruvic transaminase (GPT)
timeFrame: 6 months
Other outcomes:
measure: Skin sebum content
timeFrame: 6 months
measure: Skin hydration
timeFrame: 6 months
measure: Skin surface water loss
timeFrame: 6 months
measure: Skin melanin index
timeFrame: 6 months
measure: Skin elasticity
timeFrame: 6 months
Locations:
Study officials:
affiliation: Chung Shan Medical University
name: Chin-Kun Wang
role: STUDY_CHAIR
References:
Clinical trial NCT01526642: Home Non-invasive Ventilation for Chronic Obstructive Pulmonary Disease Patients
Official title: Home Non-invasive Ventilation Versus Long-term Oxygen Therapy in COPD Survivors of Acute Hypercapnic Respiratory Failure. A Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Hypercapnic Respiratory Failure
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2012-02-06
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic Obstructive Pulmonary disease (COPD) patients with chronic hypercapnic respiratory failure are more likely to develop exacerbations. Non-invasive ventilation has been proposed to treat acute respiratory failure but little information is available about the benefits of home non-invasive ventilation in COPD patients with chronic hypercapnic respiratory failure surviving an acute hypercapnic respiratory failure. The purpose of this study is to determine whether home non-invasive ventilation can reduce recurrent acute hypercapnic respiratory failure in COPD patients who survived an episode of acute hypoxemic respiratory failure (AHRF) treated by Non-invasive ventilation (NIV).


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* COPD patients who survived after an episode of acute hypercapnic respiratory failure
* Patients weaned from ventilation (non invasive ventilation or mechanical ventilation) for acute episode since at least seven days with stable arterial blood gas since at least two days: PaCO2 \> 55 mmHg and pH \> 7.35

Exclusion Criteria:

* Age \> 85 years old
* Non- COPD causes of respiratory failure
* Obstructive sleep apnea excluded by polysomnography
* Adverse psychosocial status
* Serious co-morbidity

Primary outcomes:
measure: Acute hypercapnic respiratory failure episode
timeFrame: up to 102 weeks
Secondary outcomes:
measure: Death
timeFrame: 1 month and every 6 months during 2 years
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU de Rouen
Study officials:
References:
citation: Lamia B, Cuvelier A, Benichou J, Muir JF. [A multi-centre randomized controlled trial of domiciliary non-invasive ventilation vs long-term oxygen therapy in survivors of acute hypercapnic respiratory failure due to COPD. Non-invasive ventilation in obstructive lung disease (NIVOLD) study]. Rev Mal Respir. 2012 Nov;29(9):1141-8. doi: 10.1016/j.rmr.2012.09.006. Epub 2012 Oct 16. French.
Clinical trial NCT05671042: Neoadjuvant Chemotherapy in Upper Tract Urothelial Carcinoma : a Retrospective Multicentric Study.
Official title: Neoadjuvant Chemotherapy in Upper Tract Urothelial Carcinoma : a Retrospective Multicentric Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Upper Excretory Tract Tumors
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with upper excretory tract tumors

Brief summary: Upper tract urothelial carcinoma incidence is about 1 /100000/year. These tumors are mostly diagnosed at an invasive stage and the standard treatment is a total nephroureterectomy.

In this population, indication of perioperative chemotherapy is still discussed. The benefit of platinum-based adjuvant chemotherapy was recently confirmed by the prospective trial POUT for pT2-T4 N0-3 M0 tumors with an improvement in recurrence-free survival of 51% in the chemotherapy arm.

However, in this situation, use of adjuvant Cisplatin-based chemotherapy may be limited by the deterioration of renal function due to renal surgery.

There are currently no recommendations on the place of neoadjuvant chemotherapy (NAC) with controversial results.

Moreover, the impact on renal function of the NAC-NUT treatment sequence has so far been little studied.

The aim of this study is to improve scientific knowledge about neoadjuvant chemotherapy in upper tract urothelial carcinoma eligible to a curative surgery. The investigators will evaluate the benefit of NAC on pathological response, overall survival and progression-free survival in a large multicentric cohort. In addition, the investigators will assess the impact of NAC on renal function at a distance from curative surgery will allow the evaluation of its specific toxicity.


Eligibility criteria: Inclusion Criteria:

1. Patients over 18 years of age
2. Male or female
3. Upper excretory tract tumors
4. Localized or locally advanced stage (N0 to N1)
5. Eligible for curative surgery
6. Have received neoadjuvant or primary chemotherapy
7. Neoadjuvant chemotherapy treatment received between 2010 and 2020.

Exclusion Criteria:

1. Patient's opposition to the research
2. UTUC not eligible for curative surgery
3. Locally advanced UTUC ≥ N2 and/or metastatic.

Primary outcomes:
measure: Pathological response rate
timeFrame: immediately after the end of chemotherapy treatment
Secondary outcomes:
measure: Progression free-survival
timeFrame: at one year
measure: Progression free-survival
timeFrame: at 2 years
measure: Progression free-survival
timeFrame: at 3 years
measure: Progression free-survival
timeFrame: at 4 years
measure: Radiological response rate
timeFrame: immediately after the end of chemotherapy treatment
measure: residual renal function assessed by creatinine clearance (mL/min)
timeFrame: at 3 months after curative surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03171142: Effect of Heliox on RSV Bronchiolitis
Official title: Effect of Heliox on Infants With Respiratory Syncytial Virus Acute Bronchiolitis-A Revisit Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: RSV Infection
Acute Bronchiolitis
Keywords: Heliox
Lead sponsor: Mansoura University Children Hospital
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 104
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Helium is an inert gas with a density almost one-seventh of that of air. Based on its properties breathing a mixture of helium and oxygen (heliox) will lead to a reduction in resistance through narrowed airways and consequently decreases the work of breathing. Participating infants with RSV acute bronchiolitis will be supplied with heliox (ration of 21 oxygen and 79 helium) delivered through a flow nasal cannula to evaluate heliox effect in improving their oxygenation. Heliox will act as an additive therapy to improve oxygenation in patients with lower respiratory tract infection caused by respiratory Syncytial Virus (RSV) and will decrease the need for more complicated therapies.


Eligibility criteria: Inclusion Criteria:

* Age fro 1 month till 2 years
* RSV acute bronchiolitis without any supplemental oxygen.

Exclusion Criteria:

* oxygen supplement or mechanical ventilation requirement
* congenital anomalies of the heart
* chronic lung disease including bronchopulmonary dysplasia
* Failure to obtain an informed consent.

Primary outcomes:
measure: Improvement in oxygenation
timeFrame: change from baseline at 24 hours after treatment
Secondary outcomes:
measure: improvement of respiratory distress
timeFrame: change from baseline at 24 hours after treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02834442: A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-7117 in Healthy Subjects
Official title: A Randomised, Double Blind, Placebo Controlled Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of MT-7117 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2016-07-15
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of MT-7117 in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy and free from clinically significant illness or disease
* Male or female subjects aged 18 to 55 years or elderly male subjects aged ≥65
* A body weight of ≥60 kg for males and ≥50 kg for females, and a body mass index ranging from 18 to 30 kg/m2

Exclusion Criteria:

* Participated in more than three clinical studies involving administration of an IMP in the previous year, or any study within 12 weeks
* Clinically significant endocrine, thyroid, hepatic, respiratory, gastro intestinal, renal, cardiovascular or skin disease, or history of any significant psychiatric/psychotic illness disorder
* Clinically relevant abnormal medical history, physical findings or laboratory values

Primary outcomes:
measure: Safety and Tolerability as measured by number of participants with adverse events
timeFrame: up to Day56
measure: Safety and Tolerability as measured by vital signs
timeFrame: up to Day56
measure: Safety and Tolerability as measured by physical examination
timeFrame: up to Day56
measure: Safety and Tolerability as measured by ECG
timeFrame: up to Day21
measure: Safety and Tolerability as measured by laboratory safety assessments
timeFrame: up to Day21
Secondary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: 96 hours post dose
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: 96 hours post dose
measure: Time to maximum plasma concentration (Tmax)
timeFrame: 96 hours post dose
measure: Apparent elimination half-life in plasma
timeFrame: 96 hours post dose
Other outcomes:
Locations:
city: United Kingdom
country: United Kingdom
facility: Investigational center
Study officials:
References:
Clinical trial NCT05270642: Plan for Microwave Thermal Field
Official title: Research on Intelligent System of Plan for Microwave Thermal Field for Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hepatocellular Carcinoma
Ablation
Keywords: hepatocellular Carcinoma
microwave ablation
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2022-03-08
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Develop an intelligent system based on contrast-enhanced ultrasound and clinical information to help doctors automatically obtain ablation parameters (ablation needle number, ablation needle type, ablation time,ablation power) when preparing to use microwave ablation to treat hepatocellular carcinoma


Eligibility criteria: Inclusion Criteria:

1. Biopsy or clinical diagnosis of HCC
2. Complete clinical information and preoperative CEUS
3. Curative treatment

Exclusion Criteria:

1. Palliative care
2. Intolerance to ablation
3. Severe coagulation disorder

Primary outcomes:
measure: MRI within 3 days after ablation
timeFrame: MRI within 3 days after ablation
measure: local tumor progression
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT03613142: Comparison Between Double Tract Anastomosis and Esophagogastrostomy After Radical Proximal Gastrectomy
Official title: Comparison Between Double Tract Anastomosis and Esophagogastrostomy After Radical Proximal Gastrectomy: A Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
GastroEsophageal Cancer
Keywords: Double tract
Esophagogastrostomy
Gastric cancer
GastroEsophageal Cancer
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2018-08-02
Enrollment: 202
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The patients with upper gastric cancer (cT1N0M0) or gastroesophageal adenocarcinoma (diameter less than 4 cm) will be enrolled into this study. Each of these patients will undergo radical proximal gastrectomy and be randomly allocated into one of the two groups, double tract anastomosis group or esophagogastrostomy group. The following data will be collected to compare the difference between the two reconstruction methods: the rate of reflux esophagitis, postoperative quality of life, economic expenditure, the safety of operation, postoperative recovery, postoperative nutrition status and oncological effect. Through the comprehensive analysis, the result of this study will elucidate the best of the reconstruction method after proximal gastrectomy.


Eligibility criteria: Inclusion Criteria:

1. Patients diagnosed as gastric or esophagogastric adenocarcinoma
2. Age ranges from 18 to 80
3. Karnofsky assessment no less than 70
4. Completion of abdominal CT scan and ultrasound endoscopy
5. Upper gastric cancer (cT1N0M0) or esophagogastric adenocarcinoma (diameter no more than 4 cm)
6. radical proximal gastrectomy
7. Normal blood routine examination and biochemical test

Exclusion Criteria:

1. Patients need to undergo total gastrectomy or distal gastrectomy
2. Female patients with pregnancy
3. Not suitable for operation
4. Patients have already joined other clinical trials

Primary outcomes:
measure: Rate of reflux esophagitis after operation
timeFrame: 12 months
Secondary outcomes:
measure: postoperative quality of life
timeFrame: 12months
measure: postoperative quality of life
timeFrame: 12months
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Cancer Hospital & Institute
name: Xin Ji, M.D.
role: PRINCIPAL_INVESTIGATOR
References: