louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06342830: Comparing the Effect of Different Intracanal Dressing on Failed Root Canal Treated Cases on Periapical Healing
Official title: Comparison of the Effects of Different Natural and Synthetic Intracanal Medicaments on the Healing of Periapical Lesion in Retreatment Cases (A Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Periapical Disease
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-04-02
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the effects of different intracanal medication between endodontic retreatment visits in previously failed root canal treatment patients (single root canal anteriors or premolars teeth). The main question it aims to answer are:

* Is natural and synthetic intracanal Medicament effective in reducing or complete healing of Periapical lesions or not? the researchers will compare the effect of different intracanal dressing including:
* nanocurcumin gel
* curcumin gel
* ciprofloxacin +ibuprofen gel
* calcium hydroxide Paste as control group in between the endodontic retreatment visits to see if these medicaments work well on periapical lesion healing this outcome measured by Cone beam CT at base and after 1 year follow up period


Eligibility criteria: Inclusion Criteria:

* Medically free Patients
* both sex includes male and females
* Patients age between 20-60
* Patients agreement positively to share in the study
* patient able to sign informed consent
* on clinical and radiographic examinations, the included teeth maxillary and mandibular single root canal anteriors or premolars suffering from failed endodontic treatment with periapical lesion

Exclusion Criteria:

* badly broken down teeth indicated for extraction or with difficult isolation
* teeth with former procedural errors as ledge, perforation or instrument separation
* Medically compromised patients
* patients with history of receiving antibiotics within a month before starting study
* periodontally affected teeth by pocket depth \& \> 4mm

Primary outcomes:
measure: healing of periapical lesion
timeFrame: 1 year
Secondary outcomes:
measure: antibacterial effect (CFU)
timeFrame: at first visit : S1 :baseline sample, S2 : sample immediately after chemomechanical procedure , at second visit S3: sample after 7 days of placement medication
measure: Interappointment Pain
timeFrame: 6,12, 24, 48, 72 hours after 1st visit
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: faculty of dentistry, Ain shams university
Study officials:
affiliation: faculty of dentistry, zagazig university
name: Rawda MO Baghdady
role: PRINCIPAL_INVESTIGATOR
affiliation: faculty of dentistry, Ain Shams university
name: sarah H Fahmy
role: STUDY_CHAIR
affiliation: faculty of dentistry, Ain Shams university
name: karim M El Batouty
role: STUDY_DIRECTOR
References:
Clinical trial NCT04004130: Ultrasound Imaging of Subarachnoidal Space in Newborn Infants
Official title: Ultrasound Imaging of the Subarachnoidal Space at the Lumbar Region in Preterm and Term Newborn Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ultrasound
Newborn Infant
Lead sponsor: Szeged University
Sponsor class: OTHER
Collaborators: name: Affidea Magyarország
First posted: 2019-07-01
Enrollment: 2000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Based on the ultrasound measurement of CSF/spinal cord ratio in neonates the investigators plan to define a normal range of CSF volume for 0-7 day old newborns. The investigators hypothise to be able to create an ultrasound measurement index/number to predict unsuccessful neonatalal LPs.

Detailed description: Based on the available literature the success rate of neonatal lumbar puncture (LP) is quite low (some articles reporting as low as 50% (unsuccessful LPs including dry taps and traumatic taps)).

Firstly, the investigators would like to set a normal range of CSF:spine ratio (representing the amount of CSF at the expected level of LP) based on the measurements in neonates of different gestational age and postnatal age with assessing ventricular index (VI) on cranial US.

In the next phase of the study the investigators plan to assess the subarachnoidal space/amount of CSF of those neonates whom need LP performed. The investigators hypothise to be able to create an ultrasound measurement index/number that would be able to predict unsuccessful LPs.

Eligibility criteria: Inclusion Criteria: All neonates born at the Obstretrics and Gynecology Department, University of Szeged and all treated neonates at the Neonatal Unit, Pediatric Department, University of Szeged

Exclusion Criteria: Hemidynamical instability, Strict minimal handling (eg Pulmonary Hypertension, MAS etc), Total Body Coooling for HIE (Hypoxic Ischemic Encephalopathy)

Primary outcomes:
measure: Normal lumbal CSF index in neonates
timeFrame: From Day 1 to Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: Szeged University, Department of Paediatrics
Study officials:
References:
Clinical trial NCT02836730: Long-term Outcomes of Surgical and Nonsurgical Management of Sciatica Secondary to a Lumbar Disc Herniation or Spinal Stenosis
Official title: Long-term Outcomes of Surgical and Nonsurgical Management of Sciatica Secondary to a Lumbar Disc Herniation or Spinal Stenosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Disc Herniation
Lumbar Spinal Stenosis
Lead sponsor: Back and Rehabilitation Center, Copenhagen
Sponsor class: OTHER_GOV
Collaborators: name: University Hospital Bispebjerg and Frederiksberg
name: University of Southern Denmark
First posted: 2016-07-19
Enrollment: 425
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with low back pain referred to surgical evaluation with positive MRI findings, persistent low back pain, and poor outcome following non-operative treatment

Brief summary: The rate of success 12 months after surgery is reported to be 60-65% in patients with lumbar disc herniation and 60-70% in patients with spinal stenosis.

At the Back Center Copenhagen, patients with persistent low back pain caused by lumbar disc herniation and spinal stenosis are treated by a multidisciplinary team comprising rheumatologists, physiotherapists, chiropractors, and social workers according to current guidelines. Therefore we have a unique opportunity to report the long term outcome in candidates for surgery, regardless of whether they have surgery or not, after having received optimal but unsuccessful nonsurgical treatment.

The purpose of this study is to answer the following questions: 1) What is the proportion of patients operated upon after referral to surgical evaluation with positive MRI findings, persistent low back pain, and poor outcome following non-operative treatment? 2) What was the outcome in these patients 2 years following referral? 3) Where any baseline variables predictive of good or poor postsurgical outcome? 4) Where there any difference in outcome in patients with or without surgery?


Eligibility criteria: Inclusion Criteria:

* Duration of symptoms more than 3 months
* Positive imaging findings
* Non-surgical treatment unsuccessful

Exclusion Criteria:

* Age below 18 or above 65 years
* Lumbar fusion
* Psychiatric disorders
* Other serious diseases
* Unable to understand the Danish language

Primary outcomes:
measure: Disability
timeFrame: 2 years follow-up
Secondary outcomes:
measure: Back og leg pain
timeFrame: 2 years follow-up
measure: Global outcome
timeFrame: 2 years follow-up
measure: Reoperation during follow-up
timeFrame: 2 years follow-up
measure: Sick leave because of back pain
timeFrame: 2 years follow-up
measure: Contacts to the health care system because of back pain
timeFrame: 2 years follow-up
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Back and Rehabilitation Center Copenhagen
Study officials:
References:
Clinical trial NCT01474330: A Multiple-ascending-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Pomalidomide (CC-4047) in Healthy Male Subjects
Official title: A Phase 1, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Pomalidomide (CC-4047) Following Multiple Daily Doses in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pomalidomide
safety
tolerability
pharmacokinetics
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2011-11-18
Enrollment: 33
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To evaluate the safety, tolerability, and pharmacokinetics of pomalidomide administered orally once a day for 5 days, at daily doses of 0.5 mg, 1 mg, or 2 mg.


Eligibility criteria: Inclusion Criteria:

Healthy male subjects of any ethnic origin between ages of 18 and 55 with a body mass index between 19 and 30

Exclusion Criteria:

1. Any condition, including the presence of laboratory abnormalities, or psychiatric illness, that would prevent the subject from signing the Informed Consent Document (ICD), places the subject at unacceptable risk if he were to participate in the study, or confounds the ability to interpret data from the study.
2. Presence of any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion, or plans to have elective or medical procedures during the conduct of the trial.
3. Exposure to an investigational drug (new chemical entity) within 30 days prior to the first dose administration or 5 half-lives of that investigational drug, if known (whichever is longer).

Primary outcomes:
measure: Number of participants with adverse events
timeFrame: 28 days after last dose
measure: area under the plasma concentration-time curve
timeFrame: 72 hours after last dose
measure: time to maximum observed plasma concentration
timeFrame: 72 hours after last dose
Secondary outcomes:
measure: maximum observed plasma concentration
timeFrame: 72 hours after last dose
measure: terminal elimination half-life
timeFrame: 72 hours after last dose
measure: apparent total plasma clearance
timeFrame: 72 hours after last dose
measure: apparent total volume of distribution, and accumulation ratio
timeFrame: 72 hours after last dose
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Phase I Clinic
state: Texas
Study officials:
affiliation: Celgene
name: Maria Palmisano
role: STUDY_DIRECTOR
References:
Clinical trial NCT02255630: Anaerobic Power and Salbutamol
Official title: The Effects of High-dose Salbutamol on Anaerobic Cycling Power
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ergogenic Athletic Performance
Keywords: salbutamol
exercise-induced bronchoconstriction
anaerobic power
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: Natural Sciences and Engineering Research Council, Canada
First posted: 2014-10-02
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Athletes using inhaled β2-adrenoreceptor agonists (IBAs) win a disproportionate number of medals. However, most previous research has shown that β2 agonists do not improve exercise performance in either asthmatic or non-asthmatic athletes. Although the majority of these studies do not show an ergogenic effect, the small number of studies with extended exercise bouts (\~60 minutes) do show an advantage. The investigators believe that a controlled yet sport-specific exercise protocol will elucidate this ergogenic effect. Because IBAs may have different effects on these two groups of athletes, the investigators will measure exercise performance in both female and male elite cyclists. The investigators hypothesize that athletes will perform better during a combination steady-state/sprint exercise task following salbutamol administration.


Eligibility criteria: Inclusion Criteria:

* maximal oxygen consumption of ≥60 and ≥55 mL⋅kg-1⋅min-1 or ≥5⋅L⋅min-1 and ≥4⋅L⋅min-1 for men and women

Exclusion Criteria:

* pregnant women
* any history of uncontrolled respiratory or cardiac disease
* smokers
* diabetics

Primary outcomes:
measure: Peak Power Output
timeFrame: peak power output of the final 30 seconds of the cycling bout will be assessed.
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: University of British Columbia, Environmental Physiology Laboratory
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Michael S Koehle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06299930: Locoregional Recurrence After Neoadjuvant Versus Adjuvant Chemotherapy
Official title: Locoregional Recurrence After Neoadjuvant Versus Adjuvant Chemotherapy Based on Tumor Subtypes in Patients With Early-stage Breast Cancer: A Multi-institutional Retrospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 10328
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients who underwent breast-conserving surgery for breast cancer between January 1, 2004 and December 31, 2018 at the three leading hospitals in South Korea

Brief summary: Neoadjuvant chemotherapy (NACT) for early-stage breast cancer is associated with an increased risk of locoregional recurrence (LRR). However, few studies have conducted subgroup analyses of patients with various molecular subtypes, which are one of the determinant factors for treatments. The aim of the study is to investigate whether the risk of LRR after NACT varies across tumor subtypes. The investigators retrospectively reviewed the medical records of female breast cancer patients who underwent breast-conserving surgery at three institutions between January 1, 2004, and Dec 31, 2018.


Eligibility criteria: Inclusion Criteria:

* Patients who underwent breast-conserving surgery for invasive breast cancer between 2004 and 2018

Exclusion Criteria:

* Total mastectomy
* No pre- or postoperative chemotherapy
* No radiation therapy
* Bilateral breast cancer
* Male breast cancer patients
* Secondary breast cancer
* Metachronous or synchronous cancers

Primary outcomes:
measure: Locoregional recurrence-free survival (LRR)
timeFrame: Defined as the time interval between the date of initial administration of chemotherapy and date of pathological or radiological confirmation of LRR, assessed up to 120 months
Secondary outcomes:
measure: Distant metastasis-free survival
timeFrame: Defined as the time interval between the date of initial administration of chemotherapy and date of pathological or radiological confirmation of distant metastasis, assessed up to 120 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT04399330: ME/CFS, Hypermobility and Craniocervical Obstructions
Official title: Hypermobility and Obstructions in the Craniocervical Region Among Patients With Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Fatigue Syndrome
Lead sponsor: Bragee Clinics
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2020-05-22
Enrollment: 225
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 190 women 39 men Mean duration 9 years

Brief summary: A retrospective study on clinical and radiological findings in ME/CFS


Eligibility criteria: Inclusion Criteria:

Patients at a multidisciplinary specialist clinic accepting to participate

Exclusion Criteria:

none

Primary outcomes:
measure: Prevalence of cervical obstruction and other MRI findings
timeFrame: 1990-2020
measure: Prevalence of hypermobility
timeFrame: 1990-2020
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Bragee Clinics
Study officials:
affiliation: Bragee Clinics
name: Björn Bragée, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00418730: Efficacy Study of Topical NEOSH101 to Treat Male Pattern Hair Loss
Official title: A Phase 2 Multicenter, Randomized, Placebo- and Comparator-Controlled, Double-Blind Parallel Group Study to Evaluate the Safety and Efficacy of Topical NEOSH101 in the Treatment of Androgenetic Alopecia in Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Androgenetic Alopecia
Keywords: androgenetic alopecia
male pattern hair loss
male pattern baldness
androgenetic alopecia or male pattern hair loss
Lead sponsor: Neosil, Inc.
Sponsor class: INDUSTRY
First posted: 2007-01-05
Enrollment: 180
Sex: MALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to measure the hair growth response to topical NEOSH101 when applied twice daily to the balding scalp for 16 weeks. One hundred eighty men with Norwood/Hamilton grades III-IV with thinning in the top and center of the scalp will participate. Three equally sized treatment groups (60 men each) will receive either topical NEOSH101 2.0%, minoxidil 5%, or placebo.


Eligibility criteria: Inclusion Criteria:

* Caucasian men, in general good health, aged 18-49 years
* Norwood/Hamilton grades III-IV, with thinning hair in the vertex area

Exclusion Criteria:

* concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the subject's response to the study drug
* treatment with a systemic or locally acting medication which may interfere with the study objectives, such as minoxidil treatment in the 6 months prior to study start, finasteride treatment in the 12 months prior to study start, or treatment with other investigational hair growth products in the 6 months prior to study start

Primary outcomes:
measure: Hair density, hair growth rate, hair diameter as measured using the TrichoScan method
timeFrame: Through Study Day 197
Secondary outcomes:
measure: Assessment score of dermal tolerability
timeFrame: Through Study Day 197
measure: Physician's global assessment score
timeFrame: Through Study Day 197
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: bioskin Institute for Dermatological Research and Development GmbH
Study officials:
affiliation: Bioskin GmbH
name: Johannes Gassmueller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02579330: Trial on Use of Coloshield in Transanal and Anal Surgery
Official title: Randomized Controlled Trial on Practicability of Coloshield in Transanal and Anal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Fistula-in-ano
Rectal Polyp
Rectal Adenoma
Hemorrhoids
Anal Fissure
Lead sponsor: Cantonal Hosptal, Baselland
Sponsor class: OTHER
First posted: 2015-10-19
Enrollment: 22
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: In various transanal and anal procedures it is desirable to clean the operating field from stool contamination. Thus mechanical bowel preparation is not well tolerated by patients. Enema does not provide sufficient effect. By the use of Coloshield a rectal washout might be performed and enable a clean operating field. In this randomized controlled trial the macroscopic contamination of the rectum with and without Coloshield is compared using the Boston Bowel Preparation Score (0-3).


Eligibility criteria: Inclusion Criteria:

* Patients undergoing surgery for Fistula-in-ano, transanal resection of rectal Polyp or Adenoma, haemorrhoids or anal fissure.

Exclusion Criteria:

* Age \<18 years
* inability to give informed consent
* pregnancy
* missing informed consent
* emergency Operation (\<24hours of diagnosis and admission at emergency room)
* rectal strictures or Stenosis
* status post rectal resection or pelvic Radiation therapy
* inflammatory bowel disease with inclusion of the rectum
* need for mechanical bowel preparation

Primary outcomes:
measure: Grade of macroscopic contamination according to adjusted Boston Bowel Preparation Score (0-3).
timeFrame: during initial surgery
Secondary outcomes:
measure: Stable position of Coloshield
timeFrame: during initial surgery
measure: Injuries of the rectal mucosa
timeFrame: during initial surgery
measure: Postoperative pain (VAS-score)
timeFrame: during hospitalisation (48h)
Other outcomes:
Locations:
city: Bruderholz
country: Switzerland
facility: Kantonsspital Baselland, Department of Surgery, Bruderholz
Study officials:
affiliation: Cantonal Hospital Baselland, Switzerland
name: Daniel C Steinemann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cordewener C, Zurcher M, Muller PC, Muller-Stich BP, Zerz A, Linke GR, Steinemann DC. Randomized clinical trial on the use of a colon-occlusion device to assist rectal washout. Surg Endosc. 2021 Sep;35(9):5078-5087. doi: 10.1007/s00464-020-07992-9. Epub 2020 Sep 23.