louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00762983: Observation of Use of Claritin (Loratadine) Tablet, RediTabs, and Dry Syrup in Children (Study P05834)(COMPLETED)
Official title: Claritin® Tablet 10 mg, Claritin® RediTabs® 10 mg, Claritin® Dry Syrup 1% Drug Use Investigation (Pediatrics)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rhinitis, Allergic, Seasonal
Rhinitis, Allergic, Perennial
Urticaria
Pruritus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 1003
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients who are treated with Claritin at a department of pediatrics, department of otorhinology, department of dermatology, etc. at approximately 120 institutions

Brief summary: The purpose of this study is to collect information on unexpected adverse reactions (ADRs), how often ADRs occur, and factors that can affect the safety and effectiveness of Claritin (loratadine) when used in children. Patients will be observed while they are taking Claritin, and ADRs and symptom scores will be recorded. At the end of treatment, improvement in symptoms will be recorded.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients aged 3 to 15 years who are treated with Claritin for any of the following reasons: allergic rhinitis, urticaria, itching due to skin disease (eczema, dermatitis, or pruritus cutaneous)

Exclusion Criteria:

* (None)

Primary outcomes:
measure: Unexpected adverse drug reactions (ADRs) that had not been detected in pre-approval clinical studies
timeFrame: During and at the end of the observation period
measure: Allergic rhinitis: nasal symptom scores (paroxysmal sneeze, nasal discharge, nasal congestion, and intranasal itching)
timeFrame: Before the start of treatment, during the observation period, and at the end of the observation period
measure: Urticaria, eczema, dermatitis, pruritus cutaneous: severity score of itching
timeFrame: Before the start of treatment, during the observation period, and at the end of the observation period
Secondary outcomes:
measure: Allergic rhinitis: Markedly improved, Moderately improved, Mildly improved, Unchanged, Worsened, Unassessable
timeFrame: At the end of the observation period
measure: Urticaria, eczema, dermatitis, pruritus cutaneous: Resolved, Improved, Unchanged, Worsened, Unassessable
timeFrame: At the end of the observation period
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00748683: Development of an Integrated Health Care Environment for Elderly With RFID Technology
Official title: Development of an Integrated Health Care Environment for Elderly With RFID Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Elderly
Keywords: elderly
longterm care
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-09-08
Enrollment: 15
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A falling prevention system will be established by RFID location and motion detection.

* Using RFID to detect participants' allocation indoor.
* Modifying environment parameters such as light, sound, to alert users if them enter a place with potential hazards.

Data exchange models will also developed in this project

* Interchanging different data including physiological data and RFID data into a database
* establishing interchange protocol according the HL7 standard


Eligibility criteria: Inclusion Criteria:

* Age above 65 year old
* Living in the Nursing home, Bei-Hu Branch, National Taiwan University Hospital
* with ability to independent ambulation (with or without assistive devices)

Exclusion Criteria:

* no ability to independent ambulation
* with infective diseases.

Primary outcomes:
measure: Falling rate of participants
timeFrame: End of study
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Nursing Home, Bei-Hu Branch, National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Jin-Shin Lai, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05809583: Define Predictors of Response to Ozanimod in UC Discovering Biomarkers in the Management of Ulcerative Colitis
Official title: Applying Precision Medicine to Define Predictors of Response to Ozanimod and Discovering Biomarkers in the Management of Ulcerative Colitis Using 7,000 Protein SOMAscan
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Ulcerative Colitis
Keywords: biomarkers
ozanimod
somascan
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 0
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: Patients ≥18 years of age with established diagnosis of UC starting ozanimod therapy as part of their clinical care

Brief summary: A diagnostic tool that identifies biomarkers that predict response prior to and during induction of ozanimod will have a major impact on improving outcomes in UC patients. Using SOMAscan from SomaLogic (Boulder, CO), our study aims to discover serum protein biomarkers in UC patients that predict response to ozanimod and to gain insight into the pathophysiological mechanisms underlying ozanimod response.


Eligibility criteria: Inclusion Criteria:

1. Patients ≥18 years of age with established diagnosis of UC starting ozanimod therapy as part of their clinical care
2. Patients with moderate to severe UC, determined by a 3-component Mayo score of 5-9 with an endoscopic subscore ≥ 2.Endoscopy must be performed within 90 days of ozanimod initiation
3. Elevated CRP (greater than upper limit of normal on assay) and/or fecal calprotectin (\>250 mcg/g) within 90 days of drug initiation

Exclusion Criteria:

1. Diagnosis of Crohn's disease or indeterminate colitis
2. Total (procto)colectomy
3. Ileoanal pouch anastomosis
4. Current ileostomy or colostomy
5. Untreated Clostridium difficile infection
6. Known pregnancy

Primary outcomes:
measure: Clinical response
timeFrame: 10 weeks
Secondary outcomes:
measure: Clinical response
timeFrame: 22 weeks
measure: Clinical remission
timeFrame: 10 weeks
measure: Fecal calprotectin
timeFrame: 2, 10, 22 weeks
measure: CRP
timeFrame: 2, 10, 22 weeks
measure: Corticosteroid free remission
timeFrame: 22 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Laurie Grossberg, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03968783: The Effect of Suturing Material on Scar Healing
Official title: The Effect of Suturing Material on Scar Healing; a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Heal
Cesarean Section Complications
Cesarean Wound Disruption
Suture Related Complication
Keywords: cesarean section
scar heal
isthmocele
suture material
saline infusion sonography
Lead sponsor: Bezmialem Vakif University
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 95
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We want to compare the effects of 2 suture materials (monofilament and multifilament) on healing of the uterine scar after a cesarean delivery.

Detailed description: Cesarean section (CS) is the most common type of obstetric surgery. When medically justified, CS can effectively prevent maternal and perinatal mortality and morbidity however, there are many short and long-term complications of CS. One of the most common complications is the CS scar defect. CS scar defects can develop after transverse incision of the lower uterine segment, which may result in prolonged postmenstrual bleeding, spotting, pelvic pain, and infertility. Suture material is an essential part of any major surgery, serving to hold opposing tissues together and accelerate the healing process, resulting in decreased scarring of the affected areas. We sought to evaluate the effects of different synthetic absorbable suture materials on cesarean scar defect formation.

Eligibility criteria: Inclusion Criteria:

* singleton pregnancy at term \>37 weeks of gestational age

Exclusion Criteria:

* history of previous cesarean section
* history of previous uterine surgery
* multiple gestation, placenta previa, polyhydramnious, fetal macrosomia
* uterine atony history
* gestational diabetes mellitus, gestational hypertension, preeclampsia, current or previous history of heart disease, liver, renal disorders or known coagulopath
* active labor (with regular uterine contractions and cervical dilatation \>4 cm

Primary outcomes:
measure: The healing ratio
timeFrame: 6 months
Secondary outcomes:
measure: blood loss
timeFrame: 24 hours
measure: additional sutures
timeFrame: 2 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bezmialem Vakıf University Hospital
Study officials:
References:
Clinical trial NCT05211583: Serial Progesterone Level Measurements During the Menstrual Cycle in Subfertile Women
Official title: Evaluation of Serum Hormone Levels Referenced to Ovulation in Subfertile Women With Regular Menses
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Subfertility, Female
Ovulation Disorder
Keywords: ovulation
progesterone
ovulatory dysfunction
subfertility
Lead sponsor: Acibadem University
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be selected from women who attended to Acıbadem University Atakent Hospital Infertility Clinic for evaluation of infertility.

Brief summary: Ovulatory dysfunction is identified in 15% of all infertile couples and it accounts for 40% of female infertility. Ovulatory dysfunction may be more subtle in women with regular menses. Detecting the day of ovulation is necessary for optimizing natural conception, diagnosis of cycle disturbances and also timing for embryo transfer in natural cycle frozen-thawed embryo transfers. In order to diagnose ovulatory dysfunction, ovulation physiology and change of reproductive hormones during the menstrual cycle should be understood. In the present study we aimed to evaluate serial serum hormonal cut-off levels referenced to ovulation in subfertile women with regular menses.


Eligibility criteria: Inclusion Criteria:

* women that have regular menses (menstrual cycle length 21-35 days)
* women who will come visits regularly
* women that are trying to conceive more than 1 year if women age is less than 35 years or more than 6 months if women age is \>35 years

Exclusion Criteria:

* women who do not menstruate regularly
* women that use hormonal contraception
* women who take drugs that will interfere with steroid hormone metabolism

Primary outcomes:
measure: Change of serum progesterone levels referenced to ovulation
timeFrame: Progesterone levels will be measured serially when dominant follicule reaches 17 mm in diameter and after that 1-2 days interval until to ovulation; 1 week after ultrasound and hormone-detected ovulation
measure: Change of reproductive hormone levels referenced to ovulation
timeFrame: Estradiol and LH levels will be measured serially when dominant follicule reaches 17 mm in diameter and after that 1-2 days interval until to ovulation.
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Acibadem University
Study officials:
affiliation: Acibadem University
name: Turgut Aydın
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01844661: Safety and Efficacy of Repeated Infusion of CELYVIR in Children and Adults With Metastatic and Refractory Tumors.
Official title: Phase 1 Trial of Celyvir in Children and Adults With Metastatic and Refractory Solid Tumors.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Children
Solid Tumors
Metastases
Keywords: Mesenchymal stem cells
Oncolytic adenovirus
Lead sponsor: Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
First posted: 2013-05-01
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators will evaluate the safety of weekly infusions (n=6) of CELYVIR in children and adults with metastatic and refractory solid tumors. CELYVIR consists in bone marrow-derived autologous mesenchymal stem cells (MSCs) infected with ICOVIR5, an oncolytic adenovirus. In addition to data on toxicities the investigators will evaluate clinical response.


Eligibility criteria: Inclusion Criteria:

* Children: Up to 18 yrs. Refractory to at least 2 previous therapy lines. Life expectancy more than 6 months. Measurable disease.
* Adults: 18-75 yrs. Refractory to at least 2 previous therapy lines. ECOG (Eastern Cooperative Oncology Group) \<2. Measurable disease.

Exclusion Criteria:

* Pregnancy.
* Central Nervous System metastasis.
* Experimental therapy during the previous month.
* Chemotherapy less than 3 weeks previous.
* Any organ functionally impaired.
* Concurrent infectious disease.

Primary outcomes:
measure: Adverse effects after intravenous infusions
timeFrame: 48 hours after each infusion
Secondary outcomes:
measure: Clinical outcome
timeFrame: Up to 2 months after the last infusion
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Niño Jesús
Study officials:
affiliation: Hospital Universitario Niño Jesús
name: Manuel Ramírez, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morales-Molina A, Gambera S, Leo A, Garcia-Castro J. Combination immunotherapy using G-CSF and oncolytic virotherapy reduces tumor growth in osteosarcoma. J Immunother Cancer. 2021 Mar;9(3):e001703. doi: 10.1136/jitc-2020-001703.
citation: Ruano D, Lopez-Martin JA, Moreno L, Lassaletta A, Bautista F, Andion M, Hernandez C, Gonzalez-Murillo A, Melen G, Alemany R, Madero L, Garcia-Castro J, Ramirez M. First-in-Human, First-in-Child Trial of Autologous MSCs Carrying the Oncolytic Virus Icovir-5 in Patients with Advanced Tumors. Mol Ther. 2020 Apr 8;28(4):1033-1042. doi: 10.1016/j.ymthe.2020.01.019. Epub 2020 Jan 21.
Clinical trial NCT02064361: High Intensity Cycling Before SCUBA Diving Reduces Post-decompression Microparticle Production and Neutrophil Activation
Official title: High Intensity Cycling Before SCUBA Diving Reduces Post-decompression Microparticle Production and Neutrophil Activation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Decompression Sickness
SCUBA Diving
Keywords: SCUBA diving
exercise,
microparticles
neutrophil activation,
high intensity exercise
Lead sponsor: University Hospital of Split
Sponsor class: OTHER
Collaborators: name: University of Maryland
First posted: 2014-02-17
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the impact of high intensity,anaerobic exercise, in the form of cycling, on SCUBA diving. Outcomes are determined by the quantification and subtype of circulating microparticles, complete blood counts, and the quantification of venous gas emboli, measured via transthoracic echocardiography, in the cardiac cavities.


Eligibility criteria: Inclusion Criteria:

* Experienced divers (\> 250 logged dives)
* Male
* Physician clearance to dive

Exclusion Criteria:

* Prior incidence of decompression sickness

Primary outcomes:
measure: Change from baseline values of number of circulating microparticles per microliter of blood
timeFrame: Prior to exercise, prior to diving, 15 and 120 minutes after surfacing
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Split
country: Croatia
facility: University of Split School of Medicine
state: Dalmatia
Study officials:
affiliation: University Hospital of Split
name: Zeljko Dujic, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thom SR, Milovanova TN, Bogush M, Yang M, Bhopale VM, Pollock NW, Ljubkovic M, Denoble P, Madden D, Lozo M, Dujic Z. Bubbles, microparticles, and neutrophil activation: changes with exercise level and breathing gas during open-water SCUBA diving. J Appl Physiol (1985). 2013 May 15;114(10):1396-405. doi: 10.1152/japplphysiol.00106.2013. Epub 2013 Mar 14.
Clinical trial NCT04370561: Outcome Following Semitubular Plate vs. Polyaxial Locking Plates
Official title: a Prospective Randomized Study on the Outcome Following Osteosynthesis of Distal Fibula Fracture Using Semitubular Plate in AO Technique vs. Polyaxial Locking Plates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Fractures
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 45
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: In this prospective study, all patients with distal fibula fractures (AO 44 B1.1, B1.2, B1.3), with indication for surgery were included. Patients were randomized to either the DePuy Synthes® one-third semitubular plate (Group I) or NEWCLIP TECHNICS, Active Ankle® polyaxial locking plate (Group II). In Group II early weight bearing was allowed after two weeks postoperatively. Primary outcome parameter was function of the ankle joint, assessed by the Olerud and Molander ankle score (OMAS), Foot and Ankle outcome score (FAOS) and Karlsson and Peterson Scoring System for Ankle function (KPSS). Secondary outcome parameter were postoperative complications. Superficial wound infection, delayed wound healing, mechanically prominent implant, skin irritations were considered as minor and deep wound infection, material loosening, loss of reduction were regarded as major complications requiring revision surgery. Clinical and radiological follow-up were performed 6 and 12 weeks, 6 months and 1 year postoperatively.


Eligibility criteria: Inclusion Criteria:

* age between 18 and 65 years
* Fracture of the distal fibula (AO 44 B1.1, B1.2, B1.3)
* Written informed consent

Exclusion Criteria:

* Pregnancy
* mental disorders
* comprehensive legal support.
* pathological and/or osteoporotic fracture
* open fracture

Primary outcomes:
measure: Ankle function
timeFrame: 12 month
Secondary outcomes:
measure: Ankle function
timeFrame: 12 month
Other outcomes:
Locations:
Study officials:
affiliation: Klinik für Unfallchirurgie, Klinikum rechts der Isar, TU München
name: Chlodwig Kirchhoff, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zyskowski M, Wurm M, Greve F, Pesch S, von Matthey F, Pfluger P, Cronlein M, Biberthaler P, Kirchhoff C. Is early full weight bearing safe following locking plate ORIF of distal fibula fractures? BMC Musculoskelet Disord. 2021 Feb 9;22(1):159. doi: 10.1186/s12891-021-04009-x.
Clinical trial NCT01158261: The Evicel Post-Authorization Surveillance Study
Official title: A Prospective, Single-Arm, Observational, Non-interventional Study for EVICEL ™ Fibrin Sealant (Human) When Used as an Adjunct to Haemostasis in Vascular Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peripheral Vascular Disease
Hemorrhage
Keywords: hemostasis
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
Collaborators: name: OMRIX Biopharmaceuticals
First posted: 2010-07-08
Enrollment: 300
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: Subjects requiring elective vascular procedures

Brief summary: The objective of this non-interventional Post Authorisation Safety Surveillance (PASS) study is to observe the clinical safety performance of EVICEL when used as suture support for haemostasis in vascular surgery.


Eligibility criteria: Inclusion Criteria:

* Subjects, 18 years or older, requiring elective, primary or repeat vascular procedures with at least one end-to-side anastomosis to the femoral artery or to an upper extremity artery
* EVICEL Fibrin Sealant is used as an adjunct to obtain haemostasis at a target anastomosis/es
* Subjects must be willing to and capable of participating in the study, and provide written informed consent

Exclusion Criteria:

* Subjects with known intolerance to blood products
* Subjects unwilling to receive blood products
* Subjects with any intra-operative findings that may preclude the use of a fibrin sealant to control suture line anastomotic bleeding
* Subject participating in another study with an investigational (pre-approved) drug or device within 30 days of surgery

Primary outcomes:
measure: Specific Safety Parameters
timeFrame: Up to 4-weeks post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Baptist Health Medical Center
state: Florida
city: Jacksonville
country: United States
facility: Memorial Hospital
state: Florida
Study officials:
affiliation: Ethicon, Inc.
name: Richard Kocharian, MD
role: STUDY_DIRECTOR
References: