louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02618057: Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia
Official title: Effects of Oral Steroid in Mycoplasma Pneumoniae Pneumonia With Lobar Consolidation or Pleural Effusion in Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Mycoplasma Pneumoniae Pneumonia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 80
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mycoplasma pneumoniae is one of the most common causes of community-acquired pneumonia in children. The clinical course is typically self-limited and benign; however, rare cases of severe pneumonia can develop despite appropriate antibiotic therapy. The investigators aim to study the effects of prednisolone on severe M. pneumoniae pneumonia with lobar consolidation or pleural effusion in children.

Detailed description: Mycoplasma pneumoniae is one of the most common causes of community-acquired pneumonia in children. The clinical course is typically self-limited and benign; however, rare cases of severe pneumonia can develop despite appropriate antibiotic therapy. The investigators aim to study the effects of prednisolone on severe M. pneumoniae pneumonia with lobar consolidation or pleural effusion in children. Participants will be randomly assigned (1:1 ratio) to receive either prednisone 1 mg/kg/d daily for 5 days or none. The primary endpoint was fever duration and analysed by intention to treat.

Eligibility criteria: Inclusion Criteria:

* Evidence of Mycoplasma pneumoniae infection
* Lobar pneumonia or pneumoniae with pleural effusion

Exclusion Criteria:

* Immunosuppresant host
* Chronic cardiovascular/pulmonary disease
* Hospital acquired infection

Primary outcomes:
measure: Fever duration
timeFrame: within the first 14 days after intervention
Secondary outcomes:
measure: Number of patients improved in chest X-ray
timeFrame: within the first 7 days after intervention
measure: Number of patients with side effect of steroid
timeFrame: within the first 14 days after intervention
measure: Number of patients improved in chest X-ray
timeFrame: within the first 14 days after intervention
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Children's Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Eun Hwa Choi, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06095557: MCG Discovery Study in Emergency Departments
Official title: Discovery Study of Using a Magnetocardiography (MCG) Device at Emergency Departments (EDs)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ACS - Acute Coronary Syndrome
NSTEMI - Non-ST Segment Elevation MI
Keywords: magnetocardiography
MCG
Lead sponsor: SB Technology, Inc.
Sponsor class: INDUSTRY
First posted: 2023-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This prospective discovery study is designed to demonstrate the feasibility of using an unshielded, mobile MCG device in an Emergency Department (ED) setting. The main question it aims to answer is whether interpretable data can be reliably collected as part of an ED workflow.


Eligibility criteria: Inclusion Criteria:

* Presents to ED with symptoms of Acute Coronary Syndrome (ACS)
* Can provide written consent

Exclusion Criteria:

* Presents to ED with ST-Elevation Myocardial Infarction (STEMI)
* Presents to ED with Atrial Fibrillation
* Clear non-ischemic cause for symptoms (i.e. trauma)
* Active thoracic metal implants

Primary outcomes:
measure: % analyzable Sandbox MCG data
timeFrame: during the procedure (MCG scan)
Secondary outcomes:
measure: Sandbox MCG safety
timeFrame: 30 days
measure: Characterization of scan results that may differentiate between high risk and low risk ACS patients
timeFrame: during the procedure (MCG scan)
measure: Characterization of scan results that may differentiate between high risk and low risk ACS patients
timeFrame: during the procedure (MCG scan)
measure: Characterization of scan results that may differentiate between high risk and low risk ACS patients
timeFrame: during the procedure (MCG scan)
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: SB Technology, Inc.
name: Kit Yee Au-Yeung, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00600457: Modified Polyurethane Film Dressing For Skin Graft Donor Sites
Official title: Modified Polyurethane Film Dressing For Skin Graft Donor Sites
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wound Healing
Keywords: healing time
pain
infection
Lead sponsor: Klinik Bogenhausen
Sponsor class: OTHER
First posted: 2008-01-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to determine whether the combination of modified polyurethane film and secondary absorbent dressing for skin graft donor sites avoids the regular uncontrolled leakage, but holds up the advantages of film dressings for this kind of wound.


Eligibility criteria: Inclusion Criteria:

* Adults over age 18 who require skin grafting

Exclusion Criteria:

* Individuals under the age of 18.

Primary outcomes:
measure: uncontrolled leakage
timeFrame: 1-10th day postoperative
Secondary outcomes:
measure: pain
timeFrame: 1-10th day postoperative
measure: infection
timeFrame: 1-10th day postoperative
measure: epithelization status
timeFrame: 10th day postoperative
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Department of Plastic, Reconstructive, Hand and Burn Surgery, Academic Hospital Munich Bogenhausen, Technical University Munich
Study officials:
affiliation: Department of Plastic, Reconstructive, Hand and Burn Surgery, Academic Hospital Munich-Bogenhausen, Technical University Munich
name: Ulf Dornseifer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Birdsell DC, Hein KS, Lindsay RL. The theoretically ideal donor site dressing. Ann Plast Surg. 1979 Jun;2(6):535-7. doi: 10.1097/00000637-197906000-00015.
citation: James JH, Watson AC. The use of Opsite, a vapour permeable dressing, on skin graft donor sites. Br J Plast Surg. 1975 Apr;28(2):107-10.
citation: Ramirez OM, Granick MS, Futrell JW. Optimal wound healing under Op-Site dressing. Plast Reconstr Surg. 1984 Mar;73(3):474-5. doi: 10.1097/00006534-198403000-00028.
citation: Barnea Y, Amir A, Leshem D, Zaretski A, Weiss J, Shafir R, Gur E. Clinical comparative study of aquacel and paraffin gauze dressing for split-skin donor site treatment. Ann Plast Surg. 2004 Aug;53(2):132-6. doi: 10.1097/01.sap.0000112349.42549.b3.
Clinical trial NCT03377257: Efficacy and Safety of Zolmitriptan by Sublingual Administration
Official title: Efficacy and Safety of Zolmitriptan by Sublingual Administration in the Treatment of Cluster Headache: A Multi-center Randomized Cross-controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Cluster Headache
Keywords: Cluster headache
zolmitriptan
Sublingual administration
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2017-12-19
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose is to evaluate the effectiveness and safety profile of zolmitriptan by Sublingual administration for the acute treatment of Cluster headache.

Detailed description: Cluster headache is a primary neurological disorder characterized by intensive attacks and severe sharp headache, can cause a range of symptoms such as conjunctival congestion, runny nose, miosis, forehead sweat. The disability resulting from cluster headache can be severe imposing a considerable health burden upon the sufferer and society. The purpose of this study, using oral zolmitriptan as the control, is to evaluate the effectiveness and safety of zolmitriptan by sublingual administration for the acute treatment of cluster headache. Patients are asked to maintain a headache diary throughout the treatment period.

Eligibility criteria: Inclusion Criteria:

* Patients older than or equal to 18 years and less than 70 years;
* The diagnosis of cluster headache is made according to The International Classification of Headache Disorders: 3rd edition (beta version)(ICHD-III β);
* Consent form signed by the participant or his/her authorized surrogate.

Exclusion Criteria:

* Patients had primary or secondary headache disorders other than cluster headache;
* Female subjects of childbearing age will be excluded if they were pregnant, lactating or planning a pregnancy in the next year or if they were not using an adequate form of birth control;
* Patients will be excluded if they had significant medical or psychiatric disease;
* Patients will be excluded if they had coronary heart disease or not suitable for the treatment of zolmitriptan.

Primary outcomes:
measure: The points-reducing of visual analogue scale several minutes after sublingual zolmitriptan tablet
timeFrame: 5, 10, 15 minutes after administration
Secondary outcomes:
measure: The percentage of side effects;
timeFrame: 3 hours
measure: The percentage of discontinued the drug
timeFrame: 3 days
Other outcomes:
Locations:
Study officials:
affiliation: Xijing Hospital
name: Li Li, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02400957: Addition of Silver Nanoparticles to a Orthodontic Primer in Preventing Enamel Demineralization Adjacent Brackets
Official title: Effectiveness of the Addition of Silver Nanoparticles to a Orthodontic Primer in Preventing Enamel Demineralization Adjacent Brackets. ECCA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Tooth Demineralization
Keywords: silver nanoparticles
demineralization
brackets
Lead sponsor: Universidad Autonoma de San Luis Potosí
Sponsor class: OTHER
First posted: 2015-03-27
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic Transbond XT in preventing enamel demineralization adjacent to brackets.

Detailed description: Randomized, split mouth, double-blind, placebo controlled trial. Half of the mouth was applied silver nanoparticles incorporated into the primer orthodontic Transbond XT and the other half with primer-bond as placebo. Evaluate the effectiveness with Diagnodent - pen in preventing enamel demineralization adjacent to brackets.

Eligibility criteria: Inclusion Criteria:

* Patients candidates for orthodontic treatment.

Exclusion Criteria:

* Patients with O.D 11 and / or 21 absent.

  * Patients who present dentures of any kind in OD 11 and 21.
  * Patients presenting endodontic OD 11 and 21.
  * Patients presenting data gingivitis day cementing brackets.

Primary outcomes:
measure: enamel demineralization (Diagnodent - pen evaluation)
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Luis Potosi
country: Mexico
facility: Gabriela Moreno Meraz
Study officials:
affiliation: Universidad Autonoma San Luis Potosi
name: Mauricio Pierdant, Profesor
role: STUDY_DIRECTOR
References:
citation: Hernandez-Sierra JF, Galicia-Cruz O, Angelica SA, Ruiz F, Pierdant-Perez M, Pozos-Guillen AJ. In vitro cytotoxicity of silver nanoparticles on human periodontal fibroblasts. J Clin Pediatr Dent. 2011 Fall;36(1):37-41. doi: 10.17796/jcpd.36.1.d677647166398886.
Clinical trial NCT06051357: Proof of Concept Study to Assess the Efficacy, Safety of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria
Official title: An Multicenter, Randomized, Open-label Proof of Concept Study to Assess the Efficacy, Safety of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Paroxysmal Nocturnal Hemoglobinuria
Lead sponsor: Chengdu Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-09-22
Enrollment: 26
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 multicenter, randomized, open-label phase II clinical trial. A total of 24 patients with paroxysmal nocturnal hemoglobinuria naïve to complement inhibitor therapy were included. Subjects were treated with HRS-5965 for 12 weeks.


Eligibility criteria: Inclusion Criteria:

1. Diagnosis of PNH confirmed by flow cytometry with clone size ≥ 10%.
2. Have not received complement inhibitor therapy ;
3. LDH \> 1.5×ULN;
4. Hemoglobin level \< 10 g/dL.

Exclusion Criteria:

1. Known or suspected hereditary or acquired complement deficiency;
2. Patients with laboratory evidence of bone marrow failure (reticulocytes \<100x109/L; platelets \<30x109/L; neutrophils \<0.5x109/L);
3. Presence or suspicion of a systemic active bacterial, viral, or fungal infection (based on judgment of the investigator) within 2 weeks prior to the first dose of HRS-5965;
4. History of infection with capsular bacteria (e.g., meningococcus, pneumococcus, etc.)
5. Positive of HIV, HBsAg or HCVAb.

Primary outcomes:
measure: Changes in hemoglobin.
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in LDH.
timeFrame: 12 weeks
measure: Changes in haptoglobin.
timeFrame: 12 weeks
measure: Changes in bilirubin.
timeFrame: 12 weeks
measure: Changes in reticulocyte counts.
timeFrame: 12weeks
measure: Changes in C3 complement fragment deposition.
timeFrame: 12 week
measure: Percentage of patients who did not receive a blood transfusion.
timeFrame: 12 weeks
measure: Number of RBC units of transfused.
timeFrame: 12weeks
measure: Incidence and severity of adverse events
timeFrame: 16 weeks
measure: Incidence of thromboembolic events.
timeFrame: 16 weeks
measure: Plasma concentration of HRS-5965.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
state: Beijing
city: Tianjin
country: China
facility: The Blood Disease Hospital of the Chinese Academy of Medical Sciences
state: Tianjin
Study officials:
References:
Clinical trial NCT05119257: (Bispecific) Antibodies in Cancer Patients
Official title: (Bispecific) Antibodies in Cancer Patients (InHeAb01)
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Cancer
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2021-11-15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: The aim of this project is to provide (bispecific) antibodies to individual patients with advanced solid and hematological malignancies without any available approved treatment options.

Detailed description: Ethics: Patient treatment will be conducted according to §13 Absatz 2b, AMG (German law).

All (bispecific antibodies) applied are developed and manufactured by the principle investigator Prof. Helmut Salih.

Eligibility criteria: Inclusion Criteria:

* Documented diagnosis of advanced malignant disease
* Advanced malignant disease without any available standard of care treatment option
* Live expectancy \> 3 month
* Ability to understand and voluntarily sign an informed consent form.
* Ability to adhere to the visit schedule and other protocol requirements
* Eastern Cooperative Oncology Group (ECOG) performance status score of ≤ 2.

Exclusion Criteria:

* Pregnant or lactating females.
* Treatment regimens inducing severe T cell deficiencies
* Treatment-related side effect from prior cancer treatment \> CTC grade 2 (CTCAE V5.0)
* Participation in any clinical study or having taken any investigational therapy, which would interfere with the studys primary and secondary end points within 2 weeks prior to Ab treatment.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
state: Baden-Wuerttemberg
Study officials:
References:
Clinical trial NCT04180657: Ghrelin Levels in Patients With Protein C Deficiency
Official title: Investigation of Ghrelin Levels in Patients With Protein C Deficiency
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Protein C Deficiency
Keywords: ghrelin
growth hormone
protein C deficiency
appetite
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2019-11-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with protein C deficiency and gender and BMI matched controls.

Brief summary: In rodents with protein C deficiency elevated levels of ghrelin has been observed. The purpose of this study is to investigate if patients with protein C deficiency also have elevated levels of ghrelin, and if so, how this affects the patients.

30 patients with protein C deficiency and 30 healthy BMI and gender matched controls are recruited. Bloodsamples are taken in order to measure ghrelin and GH levels and other metabolic parameters. The patients and controls are also asked to answer a questionaire regarding appetite.

If patients with protein C deficiency have higher levels of ghrelin than the general population, this will lead to new studies that will perhaps help us understand the importance of ghrelin in humans.


Eligibility criteria: Inclusion Criteria:

* protein C deficiency or healthy subjects
* age 18-70
* BMI 18-35
* written statement to join the study

Exclusion Criteria:

* chronic illness, apart from protein C deficiency and lifestyle diseases
* everyday medication apart from statins, oral diabetes medication and antihypertensive drugs.
* blood donation within three months prior to the investigation.
* Alcohol abuse

Primary outcomes:
measure: acyl ghrelin and des acyl ghrelin measured in mg/dl
timeFrame: 6 month
Secondary outcomes:
measure: Growth hormone measured in pmol/L
timeFrame: 6 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05600257: The Effect of Digital Breast Tomosynthesis in Breast Cancer Long-term Survival: a Single Institution Study
Official title: The Effect of Digital Breast Tomosynthesis in Breast Cancer Long-term Survival: a Single Institution Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: breast cancer
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 1517
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals were diagnosed with breast cancer according to the International Disease Classification Criteria from September 2011 to December 2015.

Brief summary: To investigate whether digital breast tomosynthesis (DBT) benefits survival improvement.

Detailed description: To suggest DBT for specific populations, compare the overall survival rate of women with digital mammography (DM) to the DBT screening for women with particular characteristics.

Eligibility criteria: Inclusion Criteria:

* individuals were diagnosed with breast cancer according to the International Disease Classification Criteria

Exclusion Criteria:

* no surgery or incomplete surgical pathology stage
* complete remission after neoadjuvant chemotherapy
* non-breast cancer death
* bilateral breast cancer
* male breast cancer
* no pre-surgery mammography image

Primary outcomes:
measure: Overall survival rate
timeFrame: Up to 111 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Chen-Pin Chou, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05125757: Lifestyle Modification in Psoriatic Patients With Fatty Liver
Official title: Response of Fatty Liver to Lifestyle Modification in Psoriasis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psoriasis
Fatty Liver
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Several recent reports have shown an increased prevalence of nonalcoholic fatty liver disease (NAFLD) in those with psoriasis, which may reflect the increased occurrence of metabolic syndrome in this patient population.

Detailed description: the recruitment of 60 fatty live men with chronic disease, psoriasis, will be classified to lifestyle modification group (foe 12 weeks, this patients will take supervised energy or diet restriction program plus their usual immunosuppressive drugs ) and control group will continue their drug program only)

Eligibility criteria: Inclusion Criteria:

* psoriasis obese patients with coexisting fatty liver
* chronic plaque psoriasis
* patients who will not show any change in immuno-modulating psoriasis therapies for at least five months before participation in the study.

Exclusion Criteria:

* no metabolic syndrome
* no renal or cardiac or pulmonary disorders
* other types of psoriasis

Primary outcomes:
measure: Psoriasis Area and Severity Index
timeFrame: It will be measured after 12 weeks
Secondary outcomes:
measure: Dermatology Life Quality Index
timeFrame: It will be measured after 12 weeks
measure: triglycerides
timeFrame: It will be measured after 12 weeks
measure: AST
timeFrame: It will be measured after 12 weeks
measure: ALT
timeFrame: It will be measured after 12 weeks
measure: BMI
timeFrame: It will be measured after 12 weeks
measure: waist circumference
timeFrame: It will be measured after 12 weeks
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of Physical Therapy Cairo University
state: Dokki
Study officials:
affiliation: Cairo University
name: Ali Ismail, lecturer
role: PRINCIPAL_INVESTIGATOR
References: