louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06237426: An Evaluation of the Long-term Efficacy and Safety of Methylone for the Treatment of PTSD
Official title: A 52-Week, Open-Label Evaluation of the Long-term Efficacy and Safety of Single and Repeated Treatments with Methylone for the Treatment of PTSD IMPACT-EXT (Investigation of Methylone for Post-Traumatic Stress Disorder [PTSD])
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Post Traumatic Stress Disorder
Keywords: PTSD
IMPACT-EXT
Methylone
Neuroplastogen
Transcend Therapeutics
TSND-201
Lead sponsor: Transcend Therapeutics
Sponsor class: INDUSTRY
First posted: 2024-02-01
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an extension study of participants who previously completed a Transcend-sponsored clinical trial evaluating TSND-201 as a treatment for PTSD.

Participants will be followed for up to 52 weeks. During the 52 week period, PTSD symptoms and safety will be assessed monthly.

Participants' PTSD symptoms will be assessed at each observational visit and if criteria for Relapse has been met, participants may be eligible to receive a course of TSND-201 treatment.


Eligibility criteria: Inclusion Criteria:

* Participation in and successful completion of a prior Transcend-sponsored clinical trial with TSND-201.
* Agree to not participate in any other interventional clinical trials for the duration of this study.
* Willing and able to provide informed consent.

Exclusion Criteria:

* Had significant deviation(s)/non-compliance in parent study in the opinion of the Investigator which would deem them unsuitable for participation.
* Change or development of any physical or psychological finding that would make participant unsuitable for study.

Primary outcomes:
measure: Change from baseline in Clinician Administered PTSD Scale for DSM-5 (CAPS-5) total severity score
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Incidence of serious adverse events (SAEs), adverse events of special interest (AESIs), and treatment-emergent adverse events (TEAEs)
timeFrame: Up to 52 weeks
Other outcomes:
Locations:
city: Denver
country: United States
facility: Mountain View Clinical Research
state: Colorado
city: Rockville
country: United States
facility: Sunstone Medical
state: Maryland
city: Draper
country: United States
facility: Cedar Clinical Research, Inc
state: Utah
city: Galway
country: Ireland
facility: La Nua Mental Health Centre
city: Cambridge
country: United Kingdom
facility: Cambridgeshire and Peterborough NHS Foundation Trust
state: England
city: Belfast
country: United Kingdom
facility: Mirabilis Health
state: Northern Ireland
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
state: Scotland
city: London
country: United Kingdom
facility: Clerkenwell Health
city: London
country: United Kingdom
facility: Kings College
Study officials:
References:
Clinical trial NCT02527226: Post-parotidectomy Facial Paresis: Intraoperative and Postoperative Factors
Official title: Post-parotidectomy Facial Paresis: Intraoperative and Postoperative Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parotid Neoplasms
Facial Paralysis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2015-08-18
Enrollment: 76
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: This is a protocol to govern the prospective trial of facial nerve monitoring in patients undergoing parotidectomy with an eye towards interpreting if the facial nerve monitor provides useful information to operating surgeons and if the information provided by the facial nerve monitor can predict degrees of postoperative facial nerve paresis.

Additionally, the study will determine if performing daily facial rehabilitation exercises provides a benefit in reducing time to recovery of temporary post-parotidectomy paresis.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Planned parotid gland surgery (superficial or total parotidectomy)
* Benign or malignant disease

Exclusion Criteria:

* Pregnancy
* Preoperative facial nerve dysfunction
* Revision operation
* History of preoperative radiation to the surgical field
* Entire nerve not dissected
* Intentional nerve sacrifice
* Poor signal to noise ratio during surgery
* Lack of access to device compatible with video conferencing software, or lack of access to broadband internet connection

Primary outcomes:
measure: Postoperative facial weakness
timeFrame: postoperative day 1
Secondary outcomes:
measure: Time to resolution of facial weakness
timeFrame: 3 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Eric Moore, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03178526: The Effect of Lovastatin Gel in the Treatment of Chronic Periodontitis
Official title: The Effect of Lovastatin Gel in the Treatment of Chronic Periodontitis Randomized Controlled Trial Split-mouth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Alveolar Bone Loss, Chronic Periodontitis, Lovestatin Gel, Regeneration
Lead sponsor: Islamic Azad University, Sanandaj
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 15
Sex: ALL
Minimum age (years): 35
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim: dis double-blind split-mouth clinical trial study was performed to evaluate teh clinical and radiographic effect of local delivery of lovastatin gel as an adjunct to scaling and root planning (SRP) in teh treatment of chronic periodontitis.

Method and Materials: 15 patients with two mandibular molar teeth with probing depth (PD)≥3 mm, clinical attachment level (CAL)≥3 mm and bone loss more than 3 mm according to parallel periapical x-ray and distance from CEJ to alveolar crest, were selected.Totally 24 mandibular molars were selected for teh study.

Clinical periodontal parameters included PD, CAL, bleeding index(BI), plaque index(PI) were recorded for teh selected teeth at baseline and at 1,3 and 6 months. Radiographic assessments were performed at baseline and after 6 months. At one side teh pockets around randomly selected molar were injected with a blunt syringe filled with lovastatin gel 1.2%( case group=B), and on teh other side, teh pockets were filled with a placebo gel by a blunt syringe ( control group=A).Two-way repeated measure ANOVA test and T-test were used for statistic analysis Spss 23.( P\<0.05) was considered significant.

Detailed description: Statins are an important group of hypolipidemic drugs dat are able to modulate inflammation and alveolar bone loss. Rosuvastatin (RSV) and atorvastatin (ATV) are non to inhibit osteoclastic bone resorption and has been proposed to has osteostimulative properties.

Eligibility criteria: Inclusion Criteria:

24 patients wif periodontitis chronic and TEMPhas a 2 molar symmetrically in the lower jaw pockets of periodontal depth of at least 4 mm and CAL greater than 3 mm in at least one of the surfaces of the teeth, the X-ray bars from both sides of the molar regions jaw bottom, from CEJ and alveolar crest was more than 3 mm, were selected

Exclusion Criteria:

1. systemic disease
2. pregnancy or breastfeeding
3. allergy drug used
4. smoking
5. medication 6. not willing to consent to participate in the study

7-Trismus 8-The type of disease periodontal (Aggressive) 9. History of periodontal treatment in the previous 6 months 10-orthodontic treatment

Primary outcomes:
measure: Bone defect fill
timeFrame: Three months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00699426: The Effect of Nexium and Probiotics on Insulin Secretion and Cardiovascular Risk Factors in Patients With Type 2 Diabetes
Official title: The Effect of Nexium and Cardi-04 Yoghurt on Insulin Secretion and Effect and Cardi Vascular Risk Factors Associated With the Insulin Syndrome in Patients With Type 2 Diabetes - a Randomized Double-blind, Prospective, Placebo Controlled 2 x 2 Factorial Design 3 Month's Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Lead sponsor: Steno Diabetes Center Copenhagen
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
name: Chr Hansen
name: Statens Serum Institut
name: Steno Diabetes Center Copenhagen
First posted: 2008-06-18
Enrollment: 41
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To test the effect of Nexium and probiotics on insulin secretion and cardiovascular risk factors on type 2 diabetic patients.

Study Hypothesis:

1. Nexium causes an increased gastrin secretion that increases the insulin secretion and thereby a reduction of HbA1c
2. Probiotics changes the gut flora and bloodpressure
3. Probiotics causes a change in inflammation and thrombosis.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes (WHO criteria) treated with metformin and/or sulfonylureas or diet
* Males and females between 40 and 70 years
* HbA1c between 6,0-10,0
* Diabetes duration \> 1 year

Exclusion Criteria:

* Kidney disease (s-creatinine above the upper limit of normal range).
* Liver disease (ALAT increase \> 3 times the upper limit of the normal range of ALAT).
* Macroalbuminuria (urinary albumin excretion of \> 300 mg/day).
* Heart failure(NYHA class lll or lV)
* Severe neuropathy (symptoms + vibration perception threshold \> 50 measured by biothesiometer.)
* Neutropenia (neutrophil count\<2.0x10/l) or anemia (hemoglobin\<8mM for men or \<7mM for women.
* Alcohol abuse
* Drug abuse
* Severe organic or metabolic diseases including cancer
* C-peptide\< 0,3 pmol/l
* Medicine interaction
* Treatment with insulin
* PPI or other medications for ulcus diseases
* Treatment with warfarin or other coumarin derivations
* Pregnant or breastfeeding women
* Allergy to medication used in the study
* Participants may not participate in another clinical intervention trial

Primary outcomes:
measure: insulin secretion
timeFrame: 1 year
Secondary outcomes:
measure: blood pressure
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Steno Diabetes Center Copenhagen
name: Allan A. Vaag, MD, DMSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hove KD, Brons C, Faerch K, Lund SS, Petersen JS, Karlsen AE, Rossing P, Rehfeld JF, Vaag A. Effects of 12 weeks' treatment with a proton pump inhibitor on insulin secretion, glucose metabolism and markers of cardiovascular risk in patients with type 2 diabetes: a randomised double-blind prospective placebo-controlled study. Diabetologia. 2013 Jan;56(1):22-30. doi: 10.1007/s00125-012-2714-y. Epub 2012 Sep 26.
Clinical trial NCT00211926: StaphVAX Immunogenicity in Orthopedic Implant Patients
Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Safety and Immunogenicity of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine, in Adult Patients Receiving an Orthopaedic Prosthetic Implant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Staphylococcal Infections
Joint Prosthesis
Keywords: vaccine
Staphylococcus aureus vaccine
Lead sponsor: Nabi Biopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: S. aureus is the most common pathogen involved in prosthetic joint infection. StaphVAX® is a vaccine to prevent these infections, which conjugates the purified capsular polysaccharides of S. aureus to a carrier protein. It is currently being evaluated for future licensing. This study aims to demonstrate the safety and immunogenicity of a single dose of StaphVAX in patients who are candidates for knee or hip arthroplasty.


Eligibility criteria: Inclusion Criteria:

* age 18 years or older
* candidate for knee or hip replacement
* expectation of protocol compliance
* negative pregnancy test, where appropriate

Exclusion Criteria:

* known S. aureus infection in the prior 3 months
* infection in the prior 2 weeks
* Known HIV infection
* immunomodulatory drugs
* Malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer)
* Hypersensitivity to components of StaphVAX

Primary outcomes:
measure: serotype-specific antibody concentrations
timeFrame: 6 weeks after dose
Secondary outcomes:
measure: serotype-specific antibody concentrations
timeFrame: several other time points after dose, up to 365 days
measure: safety: adverse events
timeFrame: 0-365 days
Other outcomes:
Locations:
city: Norfolk
country: United States
facility: Cllinical Research Asociates of Tidewater
state: Virginia
Study officials:
affiliation: Nabi Biopharmaceuticals
name: Preston Holley, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01063426: Re-STOP DVT: Reload of High Dose Atorvastatin for Preventing Deep Vein Thrombosis in Statin Users
Official title: Reload of High Dose Atorvastatin for Preventing Deep Vein Thrombosis in Statin Users Undergoing Total Knee Replacement Arthroplasty: RE-STOP-DVT Study- A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Thrombosis
Prevention
Surgery
Keywords: Statin
Vein
Lead sponsor: Hallym University Medical Center
Sponsor class: OTHER
First posted: 2010-02-05
Enrollment: 180
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Reload of high dose statin may have potential for preventing deep vein thrombosis (DVT) in patients on statin undergoing total knee replacement arthroplasty.

A body of evidence have been reported that reloading of atorvastatin have efficacy in reducing periprocedural myocardial infarction and contrast induced nephropathy. These effects are considered to be mainly due to their antioxidant anti-thrombotic and anti-inflammatory property.

We, therefore, hypothesize that high dose atorvastatin re-loading may prevent DVT.


Eligibility criteria: Inclusion Criteria:

* Patients who are going to receive total knee replacement arthroplasty from any cause.
* \< 19 years old

Exclusion Criteria:

* patients with cancer
* Patients receiving anticoagulant agents from any cause
* current statin users
* expecting survival from other co-morbidity \< 1year
* Bed ridden patient
* AST, ALT \> 3times of upper normal limit
* CK\> upper normal limit
* pregnancy
* patients who receives hormone replacement therapy

Primary outcomes:
measure: Development of deep vein thrombosis diagnosed and confirmed by CT angiography at lower extremities
timeFrame: 7days after index surgery
Secondary outcomes:
measure: D-dimer, lipid panel (Total cholesterol, TG, HDL, LDL), hsCRP, CK, transaminase, ALP
timeFrame: 7days, 1month, 2month after index surgery
Other outcomes:
Locations:
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital, Department of Cardiology and Orthopedic Surgery
state: Gyeonggi-do
Study officials:
affiliation: Hallym University Medical Center
name: Sang-Ho Jo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hallym University Medical Center
name: Sang-Ho Jo, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01821326: Risk Factors for Rebleeding in Patients With Obscure Gastrointestinal Bleeding
Official title: Risk Factors for Rebleeding in Patients With Obscure Gastrointestinal Bleeding
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastrointestinal Bleeding
Keywords: capsule endoscopy
obscure gastrointestinal bleeding
rebleeding
risk factors
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2013-04-01
Enrollment: 339
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent CE in Shanghai Renji Hospital ( China )from June 2002 to January 2012 for OGIB

Brief summary: The investigators investigated the rebleeding rate the risk factors for rebleeding after long-term follow-up (≥12 months) in patients who underwent capsule endoscopy for obscure gastrointestinal bleeding.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent capsule endoscopy in Shanghai Renji Hospital(China) from June 2002 to January 2012 for obscure gastrointestinal bleeding

Exclusion Criteria:

1. patients who did not undergo a gastroscopy and colonoscopy performed before capsule endoscopy examination; and
2. patients with follow-up examination for other know clinical diseases.

Primary outcomes:
measure: Rebleeding Rate
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: RenJi Hospital
name: Zhizheng Ge, M.D. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04355026: Use of Bromhexine and Hydroxychloroquine for Treatment of COVID-19 Pneumonia
Official title: Use of Bromhexine and Hydroxychloroquine for Treatment of COVID-19 Pneumonia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Covid-19
Lead sponsor: General and Teaching Hospital Celje
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In the current situation it is of great importance to discover a safe, cost-effective and available treatment strategy in order to limit the rapidly spreading SARS-Cov-2. Recent studies have shown that hydroxychloroquine could have a role in the treatment of infected patients. It is however not very likely that hydroxychloroquine alone could be adequate for treatment of Covid-19 disease. Effective therapy that prevents the virus entrance should contain at least TMPRSS2 inhibitor or a competitive inhibitor of viral ACE 2 binding. The use of bromhexine at the dose adequate to selectively inhibit the TMPRSS2, resulting in preventing of viral entrance via TMPRSS2-specific pathway, coud be an effective treatment of Covid-19. In our study we would like to explore the therapeutic potential of bromhexin and hydroxychloroquine in Covid-19 patients.

Hypothesis

1. Combined treatment with bromhexin and hydroxychloroquine shortens the course of disease in hospitalized Covid-19 patients compared to hydroxychloroquine alone.
2. Combined treatment with bromhexin and hydroxychloroquine lowers the incidence of secundary pulmonary infections in hospitalized Covid-19 patients compared to hydroxychloroquine alone.
3. Combined treatment with bromhexin and hydroxychloroquine decreases the need for ICU admission in hospitalized Covid-19 patients compared to hydroxychloroquine alone.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years,
* confirmed infection (positive PCR from nasopharyngeal swab),
* fullfilled hospital admission criteria

Exclusion Criteria:

* pregnancy,
* known allergy for bromhexine or hydroxychloroquine,
* epilepsy,
* prolonged QTc interval,
* Child C liver disease,
* dementia,
* psychoorganic syndrome,
* terminal chronic disease

Primary outcomes:
measure: Duration of hospitalization
timeFrame: through study completion, an average of 6 months
measure: Duration of disease
timeFrame: through study completion, an average of 6 months
Secondary outcomes:
measure: Hospital-aquired pneumonia
timeFrame: through study completion, an average of 6 months
measure: ICU stay duration
timeFrame: through study completion, an average of 6 months
measure: Oxygene therapy duration
timeFrame: through study completion, an average of 6 months
measure: Mechanical ventilatory support duration
timeFrame: through study completion, an average of 6 months
Other outcomes:
Locations:
city: Celje
country: Slovenia
facility: SB Celje
Study officials:
References:
Clinical trial NCT04492826: Postoperative Surgical Site Infection afterENT Bone Flap Surgery
Official title: Evaluation of the Occurrence of Postoperative Surgical Site Infection in Otolaryngology Flap Surgery With Bone Graft, a Retrospective Analytic Study Between 2012 and 2019
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rate of Infections
Operating Site
Post-operative Surgery
Bone Flap Surgery
Otolaryngology
Keywords: bone flap surgery
postoperative surgical infection
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient operated on for bone flap surgery by the Otorhinolaryngology surgery team in Croix-Rousse hospital (Pr CERUSE)

Brief summary: In 2017, the French Society in anesthesia and reanimation published new recommendations on intraoperative antibiotic prophylaxis. Now, no more than 48 hours of antibiotic prophylaxis applies to any otolaryngology surgery, regardless of patient's medical history or type of flap used to rebuild. This has resulted in an alignment of our local protocol in Croix-Rousse hospital.

However, after few years, our local impressions are that bone flap surgeries are very likely to provide surgical site infections (osteo-articular or non-osteo-articular infections).

The prejudice of these postoperative site infections is significant, with serious consequences,. of both functional and aesthetic sides.

We wanted to objectify this impression by retrospectively analyzing the data relating to patients operated on for bone flapsurgeries.

Knowing the operation site infection rate after surgery for otolaryngology bone flap surgery will allow us to objectively understand the infectious risk of these surgeries, in particular the risk of osteoarticular infection. Identifying operation site infection factors will allow us to better target and prevent them.

The goal is to find out if the antibiotic prophylaxis currently recommended is sufficient and effective for this type of surgery.


Eligibility criteria: Inclusion Criteria:

* Patient operated for bone flap in Croix-Rousse hospital, in otorhinolaryngology department, since september 2012 and until January 2019

Exclusion Criteria:

* patient's opposition to participate in the study

Primary outcomes:
measure: Postoperative infections rate after otolaryngology bone flap surgery
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix-Rousse
Study officials:
References: