louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01179633: Acne Treatment With Active Patches Which Contains Azelaic Acid, Citric Acid,Salicylic Acid and 2% Ascorbic Acid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acne Vulgaris
Lead sponsor: Oplon-Pure Science Ltd.
Sponsor class: INDUSTRY
First posted: 2010-08-11
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to demonstrate the effect of short treatment with active OPLON patches on Acne.

Detailed description: Patients with Acne Vulgaris were treated overnight with active patches. Effect is observed at the end of the treatment and 24 hours later.

Eligibility criteria: Inclusion Criteria:

* Acne Vulgaris
* Over 18 years
* Signing informed consent

Exclusion Criteria:

* Active treatment of acne
* Change in hormonal therapy
* Antibiotic treatment in a week prior to the experiment
* Sensitive skin
* Pregnancy

Primary outcomes:
measure: Severity Score of lesion
timeFrame: •Severity Score of lesion [Time Frame: 24 hours following patch removal]
Secondary outcomes:
measure: Severity Score of lesion
timeFrame: •Severity Score of lesion [Time Frame: 12 hours with the patch]
Other outcomes:
Locations:
city: Natanya
country: Israel
facility: Dermatology Clinic
Study officials:
affiliation: Laniado Medical Center
name: Avner Shemer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03916133: Analysis of Selective Cerebrovascular Distribution With FDCT in the Angiosuite
Official title: Evaluation of the Clinical Feasibility of Angiographic Flat-detector CT (FDCT) Perfusion Imaging (6sPBV) Technique.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ischemic Stroke
Intracranial Aneurysm
Intracranial Arterial Diseases
Cerebral Hypoxia
Intracranial Vascular Disorder
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to evaluate the clinical feasibility of the angiographic Flat Detector CT perfusion imaging (6s PBV) technique. The investigators will examine the specific vessel distribution of patients with steno-occlusive disease, treated with a surgical extracranial-intracranial bypass and assess the cerebral perfusion during test occlusion upon a neurovascular treatment and in intracranial tumor patients referred for potential pre-operative embolization.

This study encompasses three scientific objectives:

1. What is the selective contribution of an individual bypass artery to the brain perfusion?
2. Is a selective intra-arterial angiographic perfusion examination useful in the decision-making of performing pre-operative embolization of intracranial tumors?
3. What is the usefulness of performing additive 6s PBV images compared to classical 2D angiography and/or clinical neurological evaluation in case of test occlusion in the evaluation of possible mother vessel occlusion in treatment of complex neurovascular diseases?


Eligibility criteria: Inclusion Criteria:

* Patients referred for diagnostics and surgical (extracranial-intracranial bypass) treatment of steno-occlusive neurovascular disorders.
* Patients referred for hypervascular intracranial tumor resection
* Patients referred for angiographic test occlusion as part of treatment of complex neurovascular disorders.

Exclusion Criteria:

* Pregnant women or women trying to get pregnant
* People younger than 18 years old
* Patients with thyroid disorders and diabetes, especially those using medication with metformin.

Primary outcomes:
measure: Performance of flat-detector CT imaging in angiosuite
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Antwerp University Hospital
state: België
Study officials:
References:
Clinical trial NCT06020833: A Single-arm Trial of Roxadustat Combined With Retinoic Acid in the Treatment of Refractory Low-risk MDS
Official title: A Single-arm Trial of Roxadustat Combined With Retinoic Acid in the Treatment of Refractory Low-risk MDS
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Myelodysplastic Syndromes
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-09-01
Enrollment: 25
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: Roxadustat has been approved for low-risk MDS clinical trials, but the trial results are not available. For refractory low-risk MDS, the effective rate of roxadustat treatment is about 20-30%, and roxadustat combined with retinoic acid may have better efficacy in the treatment of refractory low-risk MDS.

Detailed description: Patients with low-risk myelodysplastic syndrome who are refractory to the regular treatments have to live on transfusions which lead to poor quality of life (QoL) and survival. Roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, which increases both endogenous EPO and iron metabolism, has shown promising results in several phase 3 clinical trials for chronic kidney disease.

Roxadustat comprehensively improves iron metabolism by upregulating DCYTB and DMT1 through the HIF pathway, which can promote the iron absorption and utilization. Detail mechanisms include upregulating transferrin receptors to increase iron uptake, upregulating transferrin to promote iron transport and downregulating ferritin levels to indirectly improve iron absorption and transportation.

Patients with refractory low-risk MDS were selected and given roxadustat 150mg po qod combined with retinoic acid 20mg po bid.

Eligibility criteria: Inclusion Criteria:

* Low-risk MDS unresponsive to first-line therapy

Exclusion Criteria:

* myelofibrosis
* Severe heart and kidney function bu'quan

Primary outcomes:
measure: overall response rate (OR)
timeFrame: 3, 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Carraway HE, Saygin C. Therapy for lower-risk MDS. Hematology Am Soc Hematol Educ Program. 2020 Dec 4;2020(1):426-433. doi: 10.1182/hematology.2020000127.
Clinical trial NCT05044533: A Study Evaluating Quality of Life for Participants With Atrial Fibrillation (AF) Following a Bleed (EQUAL-AF)
Official title: Evaluating QUAlity of Life of AF Patients Following a Bleed (EQUAL-AF)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: BMS-562247
Atrial Fibrillation
Oral Anticoagulant
Prospective Study
Quality of Life (QoL)
United Kingdom
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2021-09-14
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (≥18) who have Atrial fibrillation (AF) and are actively prescribed oral anticoagulant therapies (OATs) and have recently experienced bleeds, up to a maximum of 30 days prior to enrolment. No upper age limit will be applied, but patients must match all other inclusion/exclusion criteria.

Brief summary: The purpose of this observational study is to identify participants with both minor and major bleeds as a result of anticoagulant treatment for AF and evaluating their QoL through both primary and secondary care settings.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Adult patients (\>= 18 years old)
* Patients who can understand all study information and literature to provide fully informed consent
* Atrial fibrillation (AF) as the primary diagnosis
* Having a major or minor bleed up to a maximum of 30 days prior to point of enrolment
* Receiving oral anticoagulation therapy for AF

Exclusion Criteria:

* Pregnant women
* Patients with active cancer
* Patients unable to consent for themselves
* Patient on concomitant antiplatelet therapy

Primary outcomes:
measure: Distribution of characteristics of AF participants: Quality of life (QoL) data
timeFrame: Up to 90 days
measure: Distribution of characteristics of AF participants: Impact of the anticoagulation treatment
timeFrame: Up to 90 days
Secondary outcomes:
measure: Distribution of outcomes of AF participants: Timing of bleeding occurrence
timeFrame: Up to 90 days
measure: Distribution of outcomes of AF participants: Nature of the bleed
timeFrame: Up to 90 days
measure: Distribution of outcomes of AF participants: Current Bleeding treatment
timeFrame: Up to 90 days
measure: Distribution of outcomes of AF participants: Location of bleed
timeFrame: Up to 90 days
measure: Distribution of outcomes of AF participants: Documented cause of bleed
timeFrame: Up to 90 days
Other outcomes:
Locations:
city: Swansea
country: United Kingdom
facility: Local Institution - 0001
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT05626933: Buccinator Myomucosal Flap With Furlow Palatoplasty and VPI
Official title: Anatomical Restoration Cleft Palate Technique (ARC) for Secondary Velopharyngeal Incompetence Post Cleft Palate Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Velopharyngeal Insufficiency
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2022-11-25
Enrollment: 20
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Nasopharyngoscopic examination of the 20 patients with secondary VPI following 2 flap palatoplasty will be done for visualization of the velopharyngeal port, allowing assessment of the pattern and grade of velopharyngeal closure during speech and the presence or absence of a velopharyngeal gap and after VPI repair by Buccinator myomucosal flap with Furlow palatoplasty


Eligibility criteria: Inclusion Criteria:

* 5-6 years old children with previous treated complete cleft palate with 2 flap palatoplasty technique, nonsyndromic.
* lip and palate repair performed by one craniofacial surgeon

Exclusion Criteria:

* Patients with syndromic cleft lip.
* Bilateral cleft lip
* Patient older younger 5 years.
* Associated Cardiac anomalies.
* Any systemic condition

Primary outcomes:
measure: grade of velopharyngeal closure during speech
timeFrame: immediate postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Fayoum University
Study officials:
References:
Clinical trial NCT01270633: A Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers
Official title: A Multi-Center, Prospective, Randomized Study With Primatrix Dermal Repair Scaffold For The Treatment Of Diabetic Foot Ulcers
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Foot Ulcer, Diabetic
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
First posted: 2011-01-05
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: The purpose of this study is to compare the clinical and economic effectiveness of PriMatrix and Standard of Care in the treatment of diabetic foot ulcers (DFUs) in subjects with controlled diabetes mellitus and without significantly compromised arterial circulation.

Detailed description: Subjects will be considered for screening upon meeting initial eligibility criteria. After a 2 week screening period, subject will be randomized and enrolled if additional criteria is met. In particular, if wound size has decreased by greater than 40%, subject will be considered a screen fail and randomization will not take place. If all criteria including wound size at Week 3 is met, subject will be randomized and enrolled. Subjects will return weekly for a maximum of 12 weeks, or whenever healing occurs and then once more for a confirmation of healing. Week 24 will consist of a phone call to the subject to complete QOL surveys.

Eligibility criteria: Inclusion Criteria:

* Men or women ≥ 18 years of age and able to give their own consent
* Type I or Type II diabetes with investigator-confirmed reasonable metabolic control
* Study ulcer has a Wagner grade of 1 or 2
* Study ulcer size of at least 1 cm2, but not exceeding 20 cm2 in area after debridement
* A full thickness diabetic foot ulcer located on the foot or ankle
* An ulcer which has been in existence for a minimum of 30 days, prior to the day of screening.

Exclusion Criteria:

* Suspected or confirmed signs/symptoms of wound infection
* Wounds with exposed bone or tendon
* Hypersensitivity to bovine collagen

Primary outcomes:
measure: Percent of study ulcers healed
timeFrame: 12 weeks post-randomization
Secondary outcomes:
measure: Cost of Treatment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Cumming
country: United States
facility: HyperbaRXs
state: Georgia
city: Saginaw
country: United States
facility: Covenant Medical Center
state: Michigan
city: Guaynabo
country: Puerto Rico
facility: Professional Hospital
city: Ponce
country: Puerto Rico
facility: Dr. Pila Metropolitan Hospital Wound Healing Center
city: San Juan
country: Puerto Rico
facility: Caribbean Clinical Trials
city: San Juan
country: Puerto Rico
facility: Doctors' Center Hospital of San Juan
city: San Juan
country: Puerto Rico
facility: Wound and Ulcer Care Clinic of San Juan
city: Vega Baja
country: Puerto Rico
facility: Wilma N. Vazquez Hospital
Study officials:
affiliation: TEI
name: Yiannis Monovoukas, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00845533: Pharmacokinetics of Dihydroartemisinin-Piperaquine in the Treatment of Uncomplicated Malaria in Children in Burkina Faso
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Uncomplicated Malaria
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Holley-Cotec Pharmaceuticals Co., LTD.
name: Mahidol University
First posted: 2009-02-18
Sex: ALL
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This will be an open-label trial in Burkina Faso assessing the pharmacokinetics of the antimalarial combination of dihydroartemisinin/piperaquine (DP, Duocotexcin) in children. Dihydroartemisinin-piperaquine is a promising candidate for first-line therapy of malaria. We hypothesize that the disposition and pharmacokinetics of DP will be altered in children, and this will alter the efficacy and/or toxicity of DP. We will test this hypothesis in this open-label trial in Burkina Faso. The target population includes residents, aged 6 months to 10 years in Bobo-Dioulasso. Children who present to the study clinics with symptoms suggestive of malaria will be screened with a thick blood smear. Subjects who meet selection criteria of treatment efficacy will be treated and followed up for 42 days. Pharmacokinetic sampling for DP will occur on selected follow-up days.


Eligibility criteria: Inclusion Criteria:

1. Positive screening thick blood smear
2. Fever (\> 37.5ºC axillary) or history of fever in the previous 24 hours
3. Age ≥ 6 months to 10 years
4. Weight \> 5 kg
5. Absence of any history of serious side effects to study medications
6. No evidence of a concomitant febrile illness in addition to malaria
7. No history of antimalarial use in the previous two weeks
8. P. falciparum mono-infection
9. Parasite density 2000-200,000/ul
10. Provision of informed consent and ability to participate in 42-day follow-up

Exclusion Criteria:

1. Danger signs or evidence of severe malaria
2. Hemoglobin levels \< 5.0 gm/dL

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Sunil Parikh, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francsico
name: Philip J Rosenthal, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut de Receherche en Sciences de la Sante Bobo-Dioulasso
name: Jean-Bosco Ouedraogo, M.D., PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01278433: A Safety Study of IMOVAX Polio Vaccine in Selected Cities in China
Official title: Large Scale Safety Study of IMOVAX Polio in Selected Cities in China, an Observational Post Marketing Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polio
Poliomyelitis
Keywords: Polio
Poliovirus
IMOVAX Polio™
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-01-17
Enrollment: 5007
Sex: ALL
Minimum age (years): 60
Maximum age (years): 89
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of the study is to collect post marketing safety data on IMOVAX Polio vaccine in China.

Objective:

To describe serious adverse events 30 days after each dose of IMOVAX Polio™ administered at 2, 3, and 4 months of age among infants living in the study cities of China.

Detailed description: Each study participant will receive an IMOVAX Polio™ injections at 2, 3 and 4 months of age (total of 3 doses) and will be followed up for 30 days after each vaccination.

Eligibility criteria: Inclusion Criteria:

* Subject is 2 months of age or older (60-89days) when receiving the first dose of polio vaccine.
* Subject's parent /legal representative showed willingness to complete the 3 primary doses fully using IMOVAX Polio according to the schedule. one injection at 2, 3, 4 months old respectively;
* Informed consent form obtained by the subject's parent/legal representative.
* Subject plan to live in the selected study sites for at least three months after inclusion.

Exclusion Criteria:

* Subject with a history of serious illness (i.e., hypersensitivity, seizure, convulsion, encephalopathy diseases, etc.)
* Acute medical illness with or without fever within the last 72 hours.
* Vaccination planned in the 4 weeks following any trial vaccination (except Diphtheria, Tetanus, Pertussis (DTP), Hib vaccine or Pneumo vaccine)
* Participation in another clinical trial at the same time.
* Contraindications to vaccination according to IMOVAX Polio™ leaflet.
* Subject plan to leave the study sites for at least three months after inclusion.

Primary outcomes:
measure: Number of participants reporting serious adverse events and relationship to Imovax Polio vaccination.
timeFrame: Up to 30 days after each vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
state: Beijing
city: Chang Sha
country: China
city: Cheng Du
country: China
city: Chong Qing
country: China
city: Hang Zhou
country: China
city: Ji Nan
country: China
city: Kun Ming
country: China
city: Nan Jing
country: China
city: Qing Dao
country: China
city: Shen Yang
country: China
city: Shen Zhen
country: China
city: Tian Jin
country: China
city: Wu Han
country: China
city: Xi An
country: China
city: Zheng Zho
country: China
Study officials:
affiliation: Sanofi Pasteur China
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04321733: Bacteriological Study of Acute Follicular Tonsillitis
Official title: Bacteriological Study of Acute Follicular Tonsillitis in Patients Attending the ENT Outpatient Clinic of Assiut University Hospital
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Follicular Tonsillitis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-03-25
Enrollment: 66
Sex: ALL
Minimum age (years): 5
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with acute follicular tonsillitis

Brief summary: The objective of the study is to answer the following questions :-

1. Is there an actual failure rate in tonsillitis treatment with amoxicillin clavulanate ? If yes,
2. What is (are) the possible reason(s) to explain it in our locality ?

Detailed description: Tonsillitis is one of the most common diseases in the throat that occurs in the younger age group .

The predominant bacteria causing tonsillitis are group A b-haemolytic streptococci (GABHS), which are highly susceptible to the penicillin group of antibiotics.

It has been reported in the literature that the rate of penicillin failure has consistently increased from about 7% in the 1950s to almost 40% in the 2000s.

Authors propose many reasons to explain such failure rates e.g. the coexistence of oropharyngeal beta-lactamase producing bacteria .

Although there were no documented reports, it was observed that there are rising reports of failure in treatment of acute follicular tonsillitis by amoxicillin clavulanate.

Eligibility criteria: Inclusion criteria:

patients with acute follicular tonsillitis neither younger than five years nor older than 60 years old.

Exclusion Criteria:

1. Other causes of tonsillitis that do not cause suppuration .
2. Age below five , and above 60 years .
3. Patients who received antibiotic one week before presentation .
4. Immune compromised patients .
5. Patients with quinsy.

Primary outcomes:
measure: The sensitivity of the isolated organism to amoxicillin clavulanate according to culture and sensitivity test
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Brook I. Overcoming penicillin failures in the treatment of Group A streptococcal pharyngo-tonsillitis. Int J Pediatr Otorhinolaryngol. 2007 Oct;71(10):1501-8. doi: 10.1016/j.ijporl.2007.06.006. Epub 2007 Jul 17.
citation: Casey JR, Pichichero ME. The evidence base for cephalosporin superiority over penicillin in streptococcal pharyngitis. Diagn Microbiol Infect Dis. 2007 Mar;57(3 Suppl):39S-45S. doi: 10.1016/j.diagmicrobio.2006.12.020. Epub 2007 Feb 9.
citation: Sela S, Barzilai A. Why do we fail with penicillin in the treatment of group A streptococcus infections? Ann Med. 1999 Oct;31(5):303-7. doi: 10.3109/07853899908995895.