louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01983722: Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome
Official title: Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Dravet Syndrome
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2013-11-14
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Expanded access to Stiripentol for patients with Dravet Syndrome.

Detailed description: This is a treatment plan, and therefore patients will be monitored according to clinical standard of care.

Eligibility criteria: Inclusion Criteria:

* 6 months and older
* Diagnosis of Dravet Syndrome with intractable seizures

Exclusion Criteria:

* Hypersensitivity to the active substance or to any of the excipients
* Past history of psychoses in the form of episodes of delirium
* Impaired hepatic and/or renal function, defined as creatinine \>2 and/or transaminase \>4xULN

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT01847222: An Assessment of the Safety and Pharmacokinetics of Ascending Doses of SANGUINATE™ in Healthy Volunteers.
Official title: An Assessment of the Safety and Pharmacokinetics of Ascending Doses of SANGUINATE™ in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Drug Safety
Lead sponsor: Prolong Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2013-05-06
Enrollment: 2
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Safety assessment of SANGUINATE™ in Healthy Volunteers.

Detailed description: Safety and Pharmacokinetic assessment in ascending doses of SANGUINATE™ in Healthy Volunteers.

Eligibility criteria: Inclusion Criteria:

* Male Volunteers;
* Age ≥18 years and ≤45 years;
* BMI ≥20- ≤30 kg/m²
* No clinically significant screening observations

Exclusion Criteria:

* Female volunteers;
* Any history of significant cardiac, renal, neurologic, metabolic, pulmonary, gastrointestinal, chronic hepatic disease or any other disease which in the judgment of the Investigator would interfere with the study or confound the results;
* History of allergy or major allergic reactions considered to be clinically significant by the Investigator;
* Any screening assessment determined to be clinically significant by the Investigator;
* Donate blood within 60 days of screening or otherwise experienced blood loss \>250 mL within the same period;

Primary outcomes:
measure: Number of participants with adverse events as a measure of safety and tolerability.
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Facility
Study officials:
affiliation: Rambam Health Care Facility
name: Benjamin Brenner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04065022: The Trans-cutaneous Effects on Physiological Tremor Entertainment During tACS
Official title: The Trans-cutaneous Effects on Physiological Tremor Entertainment During tACS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tremor, Limb
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2019-08-22
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Transcranial alternating current stimulation (tACS) is a noninvasive neuromodulation method that works by passing alternating electric current between electrodes where at least one of them is attached to the head. This has been shown to have effects on the motor system, cognition and behavior. The exact mechanism by which tACS causes such effects is not fully understood. Some studies suggests a contribution from the stimulated peripheral nerves present in the scalp rather than direct brain effects. To test this hypothesis two arms will be done. First, 12 subjects (arm 1) will be stimulated using focused 4x1 montage with gel-filled cup-electrodes over the motor cortex and the effects will be compared between anesthetized and non-anesthetized scalp. The effects of anesthetizing the scalp will be tested on three different stimulation amplitudes off (0 mA), low (0.5 mA) and high (2.5 mA). Then, 10 subjects (arm 2) will be stimulated over the contralateral arm to exclude any direct brain stimulation effects and to test if peripheral nerve stimulation can entrain the tremor. Three outcome measurements will be measured during the experiments which are: tremor entrainment, sensation intensity and sensation threshold.


Eligibility criteria: Inclusion Criteria:

* Above 18
* Signed informed consents

Exclusion Criteria:

* Pregnancy
* History of Epilepsy
* Family history of Epilepsy

Primary outcomes:
measure: Change in tremor-stimulation phase entrainment- Session 1
timeFrame: During session one of 12 minutes length (6 minutes with stimulation ON and 6 minutes with stimulation OFF)
measure: Change in tremor-stimulation phase entrainment- Session 2
timeFrame: During session two of 12 minutes length (6 minutes with stimulation ON and 6 minutes with stimulation OFF)
measure: Change in tremor-stimulation phase entrainment- Session 3
timeFrame: During session three of 12 minutes length (6 minutes with stimulation ON and 6 minutes with stimulation OFF)
Secondary outcomes:
measure: Sensation rating
timeFrame: Measured up to 5 minutes before the start of the stimulation sessions and lasts for 10 seconds of stimulation after which the subject gives the rating
measure: Sensation threshold
timeFrame: Measured 3 minutes before the start of the stimulation sessions and lasts up to 2 minutes. Stimulation at each amplitude lasts for 10 seconds
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: KU Leuven
Study officials:
References:
Clinical trial NCT00522522: Naturalistic Study to Evaluate the Utilization of Care Services Associated to the Diagnostic Process of Any Kind of Epilepsy
Official title: Naturalistic Study to Evaluate the Utilization of Care Services Associated to the Diagnostic Process of Any Kind of Epilepsy Until Being Confirmed (EPILIVE Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epilepsy
Keywords: Naturalistic, retrospective, utilization of care services, diagnosis, epilepsy
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2007-08-29
Enrollment: 400
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients being diagnosed of any kind of EPILEPSY (criteria ILAE 2005) and with diagnosis being confirmed by a Neurologist over the last 6 months.

Brief summary: Naturalistic, multicentre, epidemiological study to evaluate the care services used during the process of diagnosis of any kind of epilepsy. Data about services since first seizure until confirmed diagnosis will be examined.


Eligibility criteria: Inclusion Criteria:

* Patients of both sexes 16 years old or older, being diagnosed of any kind of EPILEPSY (criteria ILAE) and with diagnosis being confirmed by a Neurologist over the last 6 months and with write informed consent.

Exclusion Criteria:

* Patients with epilepsy diagnosis confirmed by a Neurologist over the last 6 months before the study or with incapacity to fulfill the requirements of the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Smyrna
country: United States
facility: UCB Pharma
state: Georgia
Study officials:
affiliation: +1 877 822 9493 (UCB)
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05114122: Clinical Outcomes of Premolars Restored With Ceramic Vonlay Restorations Versus Onlay Using Modified USPHS Criteria
Official title: Clinical Outcomes of Premolars Restored With Ceramic Vonlay Restorations Versus Onlay Using Modified USPHS Criteria (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Clinical Performance of Ceramic Vonlays
Keywords: Ceramics, vonlay, onlay, fracture
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 26
Sex: ALL
Minimum age (years): 25
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation the clinical performance of premolars restored with ceramic vonlays versus onlays using modified USPHS criteria after follow-up period of 0,3,6,9,12 months

Detailed description: two groups of patients with vital premolars indicated for fixed restorations will be selected according to special inclusion criteria (n=13) in each group (total of 26). one group will receive minimally invasive cavity preparations for posterior indirect restorations either vonlay or onlay according to each group the patient will be assessed using Modified USPHS Criteria at 0,3,6,9,12 months regarding fracture, marginal integrity and marginal discoloration

Eligibility criteria: Inclusion Criteria:

1. Age range of the patients from 25-44 years old, who could read understand and write to sign the consent by himself /herself
2. Have no active periodontal or pulpal diseases, have teeth with good restorations.(19)
3. Psychologically and physically able to withstand conventional dental procedures
4. Patients with teeth problems indicated for onlay and vonlay (premolars).

   1. Decayed teeth.
   2. Teeth restored with large filling restorations.
5. Able to return for follow-up examinations and evaluation.

Exclusion Criteria:

1. Patient less than 25 or more than 44 years.
2. Patient with active resistant periodontal diseases.
3. Patients with poor oral hygiene, high caries risk and uncooperative patients.
4. Pregnant women.
5. Patients in the growth stage with partially erupted teeth.
6. Psychiatric problems or unrealistic expectations.
7. Lack of opposing dentition in the area of interest. 8- The presence of a removable or fixed orthodontic appliance, signs of bruxism or clenching, the absence of more than one unit in the posterior region

Primary outcomes:
measure: Fracture
timeFrame: change from baseline at 3,6,9,12 months
Secondary outcomes:
measure: Marginal integrity
timeFrame: 0,3,6,9,12 months
measure: Marginal discoloration
timeFrame: 0,3,6,9,12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University, 11 El-Saraya St. El Manial
state: El Manial
Study officials:
References:
Clinical trial NCT03522922: Efficacy of Microneedling With Topical Vitamin C in Treatment of Acne Scarring
Official title: Efficacy of Microneedling With Topical Vitamin C in Treatment of Acne Scarring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acne Vulgaris
Acne Scars
Keywords: Acne scars
dermaroller
vitamin C
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 30
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 study aimed to evaluate the efficacy of dermaroller and topical vitamin C- either separate or combined- in treatment of post acne scars.

prospective randomized clinical trial that was The study was a randomized controlled trial, conducted in Sohag Dermatology outpatient clinic between June 2016 and of February 2018. 30 patients with acne scars were included.

All patients were informed about the entire procedure, medication, possible side effects and outcomes. A written informed consent was signed from each participant.

Detailed description: Study population:

Each study group included 10 patients. Detailed history and full clinical examination was conducted for each patient. Patients had 6 visits at one month interval to receive treatment and evaluated one month after the end of treatment visits.

The first group:

Patients received a series of six treatments by dermaroller at 4 weeks interval and no topical anti scar treatment in between sessions.

The second group:

Received a series of six treatments by dermaroller at 4 weeks interval with the same maneuver and instructions as first group and each session was followed by immediate application of topical vit.C serum plus once daily application in between sessions.

The third group:

received once daily topical vit.C serum capsule at night for six months. With monthly evaluation.

Assessment of patients during visits was as follow:

A) Clinical evaluation by B) Photographic documentation C) Patient satisfaction D) Safety assessment

Eligibility criteria: Inclusion Criteria:

* Facial acne scars

Exclusion Criteria:

* Active inflammatory acne.
* Active infection in the treatment area (e.g., herpes simplex and verrucae).
* Melanoma or lesions suspected of malignancy.
* Isotretinoin use in the past year.
* Dermatoses (e.g., eczema and psoriasis).
* Sunburn.
* Anticoagulant therapy.
* Systemic disease (diabetes, hypertension, collagen disease or bleeding tendency).

Primary outcomes:
measure: Clinical response by (ECCA) scale
timeFrame: 9 months
Secondary outcomes:
measure: Patient satisfaction questionnaire
timeFrame: 9 months
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag Faculty of Medicine
Study officials:
affiliation: Sohag Faculty of Medicine
name: Ramadan Saleh, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03716622: A Comparison of Clarithromycin-based and Furazolidone-based Bismuth-containing Regimens for H. Pylori Eradication
Official title: A Comparison of Clarithromycin-based and Furazolidone-based Bismuth-containing Regimens for H. Pylori Eradication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Helicobacter Pylori
Keywords: Helicobacter Pylori
furazolidone
clarithromycin
bismuth-containing quadruple regimen
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 350
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: We aim to assess and compare the effectiveness of clarithromycin- and furazolidone-based regimens as primary therapies in eradicating H. pylori.

Detailed description: Helicobacter pylori plays a pivotal role in many diseases such as peptic ulcer disease and MALT lymphomas. And the prevalence of H. pylori is increasing in some parts of the world.

However, the eradication becomes increasingly difficult due to the growing antibiotic resistance. Bismuth-containing quadruple regimens are now recommended to serve as first-line therapies. Bismuth-clarithromycin-containing and bismuth-furazolidone-containing quadruple regimens are both in the list of the first regimens. And recent antimicrobial susceptibility tests showed us that the clarithromycin was increasingly resisted while furazolidone remained hardly resisted. The comparison between the effects of bismuth-clarithromycin-containing and bismuth-furazolidone-containing quadruple regimens is not so clear.

Eligibility criteria: Inclusion Criteria:

* Patients, aged between 18 and 75years old, with positive H. pylori infection that was not eradicated by previous therapies are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.

Exclusion Criteria:

* Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.

Primary outcomes:
measure: the eradication rate of the two groups
timeFrame: 26 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu hosipital
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01510522: Evaluate Adherence to Treatment With Glucophage Sachets Versus Tablets in Diabetes Type 2 Patients Previously Treated With Metformin Tablets
Official title: Evaluate Adherence to Treatment With Glucophage Sachets Versus Tablets in Diabetes Type 2 Patients, Previously Treated With Metformin Tablets
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Diabetes Mellitus Type 2
Keywords: Diabetes
Glucophage
Metformin
sachets
tablets
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck, S.L., Spain
First posted: 2012-01-16
Enrollment: 0
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 an open-label, multicenter, two-arm, parallel, randomized phase 4 study to compare the compliance in diabetes type 2 patients treated with Glucophage sachets versus patients treated with Glucophage tablets.


Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus type 2 diagnosed (Baseline Glycemia \> 7,0 mmol/L (126 mg/dL) or overload Glycemia \> 11,0 mmol/L (198 mg/dL)
* On treatment with metformin tablets
* Patients with at least 2 treated co-morbidities
* Established dose of Metformin \> 1.700 mg/day
* Age \> 18 years old
* Given informed consent

Exclusion Criteria:

* Patients not able to take medication orally
* According to Summary of Product Characteristics (SmPC)
* Participating in another clinical trial 30 days prior to randomization
* Any other illness or medical or psychiatric condition, severe and uncontrolled that could interfere in the patient's participation or in the assessment of the study results

Primary outcomes:
measure: Change from Baseline of Patient self-reported subjective compliance as assessed by Haynes-Sackett test at Month 6
timeFrame: Month 6
Secondary outcomes:
measure: Objective compliance to treatment
timeFrame: Month 3 and month 6
measure: Evaluation of treatment satisfaction and preferences with the Diabetes Treatment Satisfaction Questionnaire (DTSQ)
timeFrame: Baseline, month 3 and month 6
measure: Rate of reported adverse events
timeFrame: Month 3 and month 6
Other outcomes:
Locations:
Study officials:
affiliation: Merck, S.L., Spain
name: Medical Responsible
role: STUDY_DIRECTOR
References:
Clinical trial NCT03712722: Fecal Microbiota Transplantation (FMT) for Clostridium Difficile
Official title: Fecal Microbiota Transplantation (FMT) for Recurrent Clostridium Difficile Infection - an Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Clostridium Difficile Infection
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2018-10-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with recurrent Clostridium difficile infection

Brief summary: Faecal microbiota transplantation (FMT) is used for recurrent Clostridium difficile infection (rCDI) as part of an quality improvement initiative and conducted within the framework of Center for Faecal Microbiota Transplantation at Aarhus University Hospital (CEFTA).

Detailed description: Patients are assessed, treated and monitored at Aarhus University Hospital (AUH) as an Integrated part of the project.

Eligibility criteria: Inclusion Criteria:

* age 18 or higher
* documented recurrence of Clostridium difficile

Exclusion Criteria:

* none

Primary outcomes:
measure: Resolution of Clostridium difficile-Associated disease (CDAD)
timeFrame: 8 weeks
Secondary outcomes:
measure: Clinical effect week 8
timeFrame: 8 weeks
measure: Negative CD test week 8
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
Study officials:
References:
Clinical trial NCT03118622: Pentax Videolaryngoscopy in Children
Official title: A Comparison of Pentax AWS Videolaryngoscopy and Macintosh Laryngoscopy for Orotracheal Intubation in Children: a Randomized Controlled Trial
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation;Difficult
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 136
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients

Brief summary: Comparison of Intubation using Pentax (Pentas AWS, Pentax, Tokyo, Japan) and Macintoch in pediatric patients

Detailed description: Pentax video laryngoscope (Pentas AWS, Pentax, Tokyo, Japan) is one of indirect optical laryngoscopes which is recently developed. Several studies have shown that the Pentax-AWS® provides full views of the glottis in the majority of patients. It makes successful tracheal intubation in patients after failed intubation using a Macintosh laryngoscope.

In pediatric patients who is expected to be difficult to intubate, Pentax makes successful intubation.

Eligibility criteria: Inclusion Criteria:

* ASA 1, 2
* Scheduled surgery under general anesthesia

Exclusion Criteria:

* Intraoral disease
* Congenital anomaly
* C-spine injury
* Patients who need Rapid sequence induction

Primary outcomes:
measure: Intubation time
timeFrame: less than 10 minute
Secondary outcomes:
measure: Intubation difficulty score
timeFrame: less than 10 minute
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Ajou university school of medicine
state: Gyeonggi-do
Study officials:
affiliation: Ajou University School of Medicine
name: Jong Yeop Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yi IK, Kwak HJ, Kim KM, Ahn SH, Lee SY, Kim JY. Comparison of Pentax Airway Scope and Macintosh laryngoscope for orotracheal intubation in children: A randomised non-inferiority trial. Acta Anaesthesiol Scand. 2019 Aug;63(7):853-858. doi: 10.1111/aas.13368. Epub 2019 Mar 22.