louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03363282: Recurrence Rate of Mini-SLET vs. Limbal-Conjunctival Autograft in Primary Pterygium Excision
Official title: Recurrence Rate of Mini-SLET (Simple Limbal Epithelial Transplantation) vs. Limbal-Conjunctival Autograft in Primary Pterygium Excision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pterygium of Conjunctiva and Cornea
Keywords: Crosslinking
Lead sponsor: Instituto de Oftalmología Fundación Conde de Valenciana
Sponsor class: OTHER
First posted: 2017-12-06
Enrollment: 57
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the efficacy and safety of amniotic membrane transplantation as an adjunctive therapy after surgical excision of primary pterygium and compare the clinical outcomes with conjunctival autograft

Detailed description: Prospective Randomized Blind Clinical Trial

Sixty-four eyes of 64 patients with primary nasal pterygium have been operated by two surgeons (E. G-H, A. N-C). All patients are randomized to undergo Mini-SLET or limbal-conjunctival autograft transplantation as an adjuvant therapy after pterygium excision.

Four eyes were treated with Mini-SLET(group 1), and 26 eyes have been operated with conjunctival autograft (group 2). Patients will be followed up at 1 day, 1 week, 1, 3, 6, 9 and 12 months postoperation. The main outcome measurement was a recurrence rate after surgery.

Eligibility criteria: Inclusion Criteria:

* Patients with primary nasal pterygium \> 2mm

Exclusion Criteria:

* Pregnant
* Previous ocular surgery

Primary outcomes:
measure: Recurrence rate
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Tseng SC. Concept and application of limbal stem cells. Eye (Lond). 1989;3 ( Pt 2):141-57. doi: 10.1038/eye.1989.22.
citation: Tananuvat N, Martin T. The results of amniotic membrane transplantation for primary pterygium compared with conjunctival autograft. Cornea. 2004 Jul;23(5):458-63. doi: 10.1097/01.ico.0000116522.57227.97.
citation: Kucukerdonmez C, Akova YA, Altinors DD. Comparison of conjunctival autograft with amniotic membrane transplantation for pterygium surgery: surgical and cosmetic outcome. Cornea. 2007 May;26(4):407-13. doi: 10.1097/ICO.0b013e318033b3d4.
Clinical trial NCT00566982: A Clinical Study to Evaluate the Safety of Ospemifene
Official title: Efficacy and Long-Term Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women: A 52-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing 60 MG Oral Daily Dose of Ospemifene With Placebo
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atrophy
Vaginal Diseases
Keywords: Urogenital atrophy
Menopausal symptoms
Vulvar and vaginal atrophy in postmenopausal women
Vaginal atrophy
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hormos Medical
name: QuatRx Pharmaceuticals
First posted: 2007-12-04
Enrollment: 426
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 80
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 determine the efficacy and long-term safety of 60mg ospemifene in the treatment of VVA in postmenopausal women with intact uterus.


Eligibility criteria: Inclusion Criteria:

* Naturally or surgically menopausal
* Intact uterus
* Vaginal pH greater than 5.0
* 5% or fewer superficial cells in maturation index of vaginal smear

Exclusion Criteria:

* Evidence of endometrial hyperplasia, cancer or other pathology
* Abnormal Pap smear
* Uterine bleeding of unknown origin or uterine polyps
* Current vaginal infection requiring medication
* Use of hormonal medications
* Clinically significant abnormal gynecological findings other than signs of vaginal atrophy

Primary outcomes:
measure: Mean Change From Baseline in Percentage of Parabasal Cells in Maturation Index of Vaginal Smear
timeFrame: 12 weeks
measure: Mean Change From Baseline in Percentage of Superficial Cells in Maturation Index of Vaginal Smear
timeFrame: 12 weeks
measure: Mean Change From Baseline in Vaginal pH
timeFrame: 12 weeks
Secondary outcomes:
measure: Change From Baseline in Estradiol Levels
timeFrame: 52 weeks
measure: Change From Baseline in Luteinizing Hormone Levels
timeFrame: 52 weeks
measure: Change From Baseline in Follicle Stimulating Hormone Levels
timeFrame: 52 weeks
measure: Change From Baseline in Sex Hormone Binding Globulin Levels
timeFrame: 52 weeks
measure: Visual Evaluation of the Vagina (Baseline & Week 52)
timeFrame: 52 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05880420: EXPERIMENTAL STUDY A.R.C.O. (CANCER CAREGIVER REMOTE ASSISTANCE)TELEHEALTH HOME MEDICATION VS/OUTPATIENT MEDICATION OF CENTRAL VENOUS CATHETER PICC (PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER)
Official title: EXPERIMENTAL STUDY A.R.C.O. (CANCER CAREGIVER REMOTE ASSISTANCE) TELEASSISTED HOME DRESSING VS/ OUTPATIENT DRESSING OF PICC CENTRAL VENOUS CATHETER (PERIPHERAL INSERTION CENTRAL VENOUS CATHETER)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infections
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
Collaborators: name: Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
First posted: 2023-05-30
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Cancer patients need central venous access according to the different types of chemotherapy and support drugs for their treatment path. The presence of a central vascular access brings mechanical issues, thrombotic and infectious complications that can undermine the patient's health and the life of the catheter, therefore the management of venous accesses is clinically relevant. The prevention of infections remains mainly based on correct hand washing and compliance with aseptic techniques. This is a multicenter intervention study is composed by a single experimental arm (home) and a calibration arm (outpatient). The study is designed to evaluate that the complication rate recorded in the two groups are similar.


Eligibility criteria: * Share patient choice
* availability at the patient's home at least once a week
* availability during on line appointment time with the tutor/video

Primary outcomes:
measure: Acceptability
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
References:
Clinical trial NCT01117220: Safety And Efficacy Of Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed) (Protocol A1281196)
Official title: Four Week, Double Blind, Placebo Controlled Phase III Trial Evaluating The Efficacy, Safety And Pharmacokinetics Of Flexible Doses Of Oral Ziprasidone In Children And Adolescents With Bipolar I Disorder (Manic Or Mixed)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Bipolar Disorder
Keywords: pediatric
bipolar
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-05-05
Enrollment: 0
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if flexibly-dosed ziprasidone is safe and effective for the treatment of children and adolescents (ages 10-17) with Bipolar l Disorder (Manic or Mixed).


Eligibility criteria: Inclusion Criteria:

* Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria for Bipolar I disorder (manic or mixed)
* At the screening and baseline visits, subjects must have a Young Mania Rating Scale (YMRS) score of at least 17.
* The subject must have a Body Mass Index (BMI) z score between -1.65 and +2.00, inclusive

Exclusion Criteria:

* Imminent risk of suicide or homicide, as judged by the site investigator
* Any history of serious or unstable illness
* Risk for prolonged QT

Primary outcomes:
measure: Change from baseline to Week 4 in Young Mania Rating Scale (YMRS) total score.
timeFrame: 4 weeks
Secondary outcomes:
measure: Change from baseline in Clinical Global Impression of Severity (CGI S) score.
timeFrame: 4 weeks
measure: Clinical Global Impression of Improvement (CGI I) score
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03156920: Pretreatment With Sumatriptan on Cilostazol Induced Headache in Healthy Volunteers
Official title: Pretreatment With Sumatriptan on Cilostazol Induced Headache in Healthy Volunteers. Development of a Pragmatic Migraine Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Lead sponsor: Danish Headache Center
Sponsor class: OTHER
First posted: 2017-05-17
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To develop a pragmatic migraine model the investigators will induce headache in healthy volunteers with a phosphodiesterase inhibitor (cilostazol). The participants will be pre-treated with sumatriptan. If the headache responds to sumatriptan, the model can be used to test new drug candidates.

Detailed description: There remains a great need for more effective anti-migraine drugs with fewer side effects. Human experimental models are valuable in early phase development of new anti-migraine drugs but useful models have not yet been developed. The investigators' group has shown that Cilostazol, a phosphodiesterase inhibitor induce headache/migraine in both healthy volunteers and in patients with migraine without aura (MO).

To validate cilostazol as a model, the headache must respond to specific migraine treatment with sumatriptan.

Hypothesis: Cilostazol induces a migraine-like headache in healthy subjects. The induced headache can be pre-treated with a specific anti-migraine drug; sumatriptan.

Aim: Developing a pragmatic and valid model for the testing of new anti-migraine drugs.

Eligibility criteria: Inclusion Criteria:

Healthy subjects of both sexes Age 18-60 years Weight 50-95 kg. Females were requested to use effective contraception.

Exclusion Criteria:

Any type of headache (except episodic tension-type headache \< 1 day per week) Serious somatic or psychiatric disease Pregnancy Intake of daily medication (except oral contraceptives).

Primary outcomes:
measure: Difference in median headache score 2 hours after cilostazol
timeFrame: 2 hours
measure: Area under the headache score curve
timeFrame: 12 hours
Secondary outcomes:
measure: Difference in peak headache score
timeFrame: 12 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Katrine Falkenberg
state: Glostrup
Study officials:
References:
citation: Falkenberg K, Olesen J. Pre-treatment with sumatriptan for cilostazol induced headache in healthy volunteers. J Headache Pain. 2018 Aug 17;19(1):71. doi: 10.1186/s10194-018-0890-y.
Clinical trial NCT03020420: Clinical Trial To Study The Anti-scarring Effect Of Cicatricell
Official title: Clinical Trial To Study The Anti-scarring Effect Of Cicatricell
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Incisions
Lead sponsor: University of Toledo
Sponsor class: OTHER
First posted: 2017-01-13
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study tries to prove that Cicatricell cream significantly reduces scarring with better wound appearance as compared to no treatment.

Detailed description: At 1st post operative follow up visit, surgical incision(s) will be assessed for healing, after the sutures/staples/steri-strips are removed. To be included in the study the incision must be 5cm or greater. And bilateral incisions as in bilateral mastectomy can be included. The incisions will be divided into two sections, using an imaginary line between top and bottom, or left and right. One side of the imaginary line will have cicatricell cream applied 2 times a day for a minimum of 8 weeks and a maximum 6months. The other side of the imaginary line will remain untreated. In the case of a bilateral incision, as in bilateral breast mastectomy or AAA incisions in the groins, the cream will be applied to one entire incision and the 2nd incision will be untreated. The incision(s) will be its own control group. At the end of the treatment phase the incision(s) will be assessed again to compare the healing.

Eligibility criteria: Inclusion Criteria:

* Signed IRB approved, written informed consent.
* Patient from 18 to 60 years of age.
* Patient who recently underwent a surgery involving linear surgical skin incisions of 5cm or more or patients with two exactly symmetrical separate incisions like bilateral inguinal hernia repair or bilateral mastectomy, CT surgery patients will be included.

Exclusion Criteria:

* Known skin allergies.

Primary outcomes:
measure: Improved wound appearance
timeFrame: 8 weeks to 6 months
measure: improved wound appearance
timeFrame: 8 weeks to 6 months
measure: improved wound appearance
timeFrame: 8 weeks to 6 months
measure: Modified Vancouver Scar Scale
timeFrame: 8 weeks to 6 months
measure: Manchester Scar Scale
timeFrame: 8 weeks to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Toledo
country: United States
facility: UTMC
state: Ohio
Study officials:
References:
Clinical trial NCT04410120: Impact of Asthma Exacerbations
Official title: Impact of Asthma Exacerbations: A Qualitative Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Asthma Attack
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2020-06-01
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with previous clinician diagnosis of asthma who have had a recent (≤4 weeks) asthma attack for which they received ≥3 days of systemic corticosteroid treatment

Brief summary: The purpose of the study is to gain a deeper understanding of the impact of asthma attacks on the lives of patients who experience them. This will help us to describe the true extent of the impact of asthma attacks on factors of importance to patients which have not previously been well described, including the psychological, social, financial and emotional burden of asthma attacks.

Additionally, it is hoped that detailed questioning regarding features of asthma attacks from a patient perspective will improve our understanding of patient recognition of attacks, consistency of certain features of attacks and patient views regarding preventative strategies for attacks. Patient experiences of asthma attacks are poorly described in previous research. Hence this work is expected to provide useful insights into these experiences which will contribute to improvements in detecting, treating and preventing asthma attacks.

The study will consist of a one-off interview lasting about 45 minutes with patients who have recently had asthma attacks. We plan to recruit patients for the study from an outpatient clinic for those who have had a recent attack or from a register of patients who have volunteered for future asthma research studies. The interviews will take place in person at the Respiratory Research Unit at the Nottingham City Hospital or over the telephone depending on patient preference.


Eligibility criteria: Inclusion Criteria:

* Adults with previous clinician diagnosis of asthma (16 years and above)
* Recent (≤4 weeks) asthma attack for which patient received ≥3 days of systemic corticosteroid treatment

Exclusion Criteria:

* Anyone under the age of 16 years.
* Anyone unable to speak or understand English.

Primary outcomes:
measure: Thematic analysis of interview transcripts using framework approach
timeFrame: One off 45 minute interview
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham Respiratory Research Unit
state: Nottinghamshire
Study officials:
References:
Clinical trial NCT01485120: Accuracy Study of a Non-Invasive Blood Pressure Cuff in Comparison to an Invasive Radial Arterial Blood Pressure
Official title: Accuracy Study of a Non-Invasive Forearm Blood Pressure Cuff in Comparison to an Invasive Radial Arterial Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Keywords: Blood pressure (low, normal, high)
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2011-12-05
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to establish the performance of a blood pressure cuff. The hypothesis is that the blood pressure reading from the cuff will provide similar blood pressure as a radial artery.

Detailed description: Blood pressure reading from the cuff will provide similar blood pressure as a radial artery.

Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent or have a legally authorized representative provide written informed consent
* Any volunteer subjects ≥ 18 years of age
* Subject must have the presence of normal sinus rhythm on ECG
* Subject will return for follow-up visit from 5 days to 8 days after study procedure

Exclusion Criteria:

* Any subject who is unable to provide written informed consent
* Any subject with the presence of peripheral vascular disease in either arm
* Any subject that demonstrates an initial NIBP screening for a blood pressure distribution range that has already been filled.
* Any subject who cannot tolerate 21 repeated BP measurements
* Any subjects with clotting or bleeding disorders
* Any subjects taking medications that are considered anticoagulants or blood thinners (For example, Clopidogrel, Warfarin, Dipyridamole, Aspirin, and Enoxaparin)
* Any subject who is unable to have arterial line placed in the radial artery
* Any subject that cannot tolerate 4 fast flushes for the frequency response
* Any female subjects pregnant or lactating
* Any subject that has previously participated in this study
* Any subjects that cannot return 5 to 8 days post study procedure for a follow-up visit

Primary outcomes:
measure: Performance Comparison: NIBP Forearm Cuff Using SuperStat Algorithm vs. Invasive Radial Blood Pressure Reading
timeFrame: Approximately 2 hours
measure: Performance Comparison: NIBP Forearm Cuff Using Classic Algorithm vs. Invasive Radial Blood Pressure Reading
timeFrame: Approximately 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Clinimark
state: Colorado
Study officials:
affiliation: Clinimark, LLC
name: David Ransom, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02109120: MMP-9 Monitoring Particulate Cerebral Embolisation
Official title: Dynamic Changes of MMP9 Concentration Cross Carotid Endarterectomy Monitoring Particulate Cerebral Embolisation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Embolic Damage
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2014-04-09
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients under CEA in the PUMCH

Brief summary: 1. In carotid endarterectomy(CEA) surgery, the dynamic changes of plasma MMP9 concentration cross CEA will be identified.
2. And the part of patients suffered particulate cerebral embolic injury, their MMP9 level will increase in the early stage after CEA.


Eligibility criteria: Inclusion Criteria:

-All patients enrolled had at least ≥70% unilateral or bilateral stenosis of Internal -Carotid Artery， or those who had a \<70% stenosis but obvious cerebral ischema symptoms had been existed.

Exclusion Criteria:

* Exclusion criteria included poor temporal window
* Refused to cooperate with us
* Nonatheromatous such as takayasu arteritis and fibromuscular dysplasia.

Primary outcomes:
measure: postoperative ischemic stroke
timeFrame: 7 days after surgery
Secondary outcomes:
measure: postoperative elevation of plasma MMP9
timeFrame: perioperative phage
Other outcomes:
Locations:
city: Beijing
country: China
facility: vascular surgery department of PUMCH
state: Beijing
Study officials:
References:
citation: Molloy KJ, Thompson MM, Schwalbe EC, Bell PR, Naylor AR, Loftus IM. Elevation in plasma MMP-9 following carotid endarterectomy is associated with particulate cerebral embolisation. Eur J Vasc Endovasc Surg. 2004 Apr;27(4):409-13. doi: 10.1016/j.ejvs.2004.02.001.
Clinical trial NCT04690920: Theranostic Implication of Complementary Medicines Against Interleukin Receptors and Gp-130 Proteins
Official title: Theranostic Implication of Complimentary Medicines Against IL-6/Gp-130 in COVID-19.: An in Vitro and in Silco Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corona Virus Disease 2019 (COVID-19)
Keywords: corona virus disease 2019 (COVID-19)
Tocilizumab
Remdesivir
Interleukin receptor-6, glycoprotein-130
receptor blocker
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2020-12-31
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: IL-6 is an inflammatory marker, secrete by the cells in many pathological conditions like COVID-19 pneumonia. Interleukin 6 bind with its receptors (IL-6R) on cells surface and recruited a protein for its activation known as gp-130. Activated receptors send signals to nucleus through secondary messenger system and up regulate the expression of IL-6/GP130 domain. Total of two hundred (n=200) participants were included in the current study and divided equally in four groups. Group B is given Tocilizumab and Group C is treated with Remdesivir along with the approved standard treatment. Group D is only Given standard therapy and Group A constituted normal healthy age and sexed matched participants. Levels of gp-130 were estimated by commercially available ELISA kit. To estimate the relationship of severity of disease with gp-130 and IL-6 Pearson's correlations was used. Sensitivity and specificity for what purpose


Eligibility criteria: Inclusion Criteria:

Admitted diagnosed cases of COVID-19 infection on real time polymerase chain reaction (RT-PCR) Both male and female were included All participants were on oxygen therapy

Exclusion Criteria:

Asthmatics pulmonary fibrosis chronic obstructive pulmonary disease (COPD) Allergic to remdesivir Allergic to Actemra Refused to take consent

Primary outcomes:
measure: Ratio of partial pressure of oxygen in arterial blood to fraction of inhaled oxygen
timeFrame: 7 days
Secondary outcomes:
measure: Hospital stay
timeFrame: 15 days
measure: Oxygen demand
timeFrame: 7-15 days
measure: Viral load
timeFrame: 7-15 days
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: The University of Lahore
state: Punjab
Study officials:
affiliation: The University of Lahore
name: Arif Malik, PhD
role: STUDY_DIRECTOR
References: