louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02829866: AMIStem-H Radiographic Analysis
Official title: THP AMIStem-H: Open, Retrospective and Prospective, Monocentric, Non Randomised Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty
Replacement
Hip
Lead sponsor: Medacta International SA
Sponsor class: INDUSTRY
First posted: 2016-07-12
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received a total hip arthroplasty with AMIStem H between January 2010 and December 2011 will be invited to participate in the study during the visit at 5 years previewed by standard practice.

Brief summary: Total hip replacement (THP) is widely used for hip osteoarthritis treatment. Surgeons are constantly looking to improve all aspects related to this procedure weather is improvement of implant design, instrumentation or surgical technique. Excellent clinical and radiological results were observed at medium and long term in the last years for AMIStem system.

This observational study has the objective to survey hip prosthesis stability and function of the operated hip in patients who are not exposed to surgical risks. The principal investigator will contact all patients in order to perform the follow-up visit according to standard practice. Patients operated between January 2010 and December 2011 will be invited in the study during the clinical visit organised according to standard practice. Preoperative clinical and radiological data, intraoperative details and postoperative follow-up data at 1-year will be retrospectively collected. Five-year and ten-year data will be prospectively collected after inclusion in the study.


Eligibility criteria: Inclusion Criteria:

1. Patient who has received a total hip arthroplasty between January 2010 and December 2011
2. Patient who has received an AMIStem H femoral component
3. Patient who have signed the information letter in order to give agreement for the clinical data treatment

Exclusion Criteria:

1. Minor patient
2. Pregnant or breast feeding woman
3. Any patient who cannot or will not provide informed consent for participation in the study

Primary outcomes:
measure: Radiological analysis of radiolucency lines presence according to Gruen zone classification
timeFrame: 5 year
Secondary outcomes:
measure: radiological assessment of femoral deformation
timeFrame: 5 year, 10 year
measure: radiological assessment of femoral stem subsidence
timeFrame: 5 year, 10 year
measure: radiological assessment of cortical bone density
timeFrame: 5 year, 10 year
measure: radiological assessment of calcar resorption
timeFrame: 5 year, 10 year
measure: Radiological analysis of radiolucency lines presence according to Gruen zone classification
timeFrame: 10 year
Other outcomes:
Locations:
city: Winterthur
country: Switzerland
facility: Kantonspital Winthertur
Study officials:
References:
Clinical trial NCT01910766: Coenzyme Q10 and Clomiphene Citrate (CC) for Ovulation Induction in Polycystic Ovary Syndrome
Official title: Combined Coenzyme Q10 and Clomiphene Citrate (CC) for Ovulation Induction in CC-resistant Patients With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Polycystic Ovary Syndrome
Keywords: pcos
coenzymeQ10
clomiphene citrate
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2013-07-30
Enrollment: 110
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective of the study was to evaluate the effect of combination of oral Coenzyme Q10 (CoQ10), with clomiphene citrate (CC) for ovulation induction in CC-resistant polycystic ovary syndrome (PCOS).In a prospective controlled randomized trial performed in a university hospital and private practice setting. One hundred ten infertile women with PCOS resistant to CC were randomized to either combined CC/CoQ10 (51 patients, 82 cycles) or CC 150 mg/day alone (50 patients, 71 cycles) for ovulation induction in patients with CC-resistant PCOS.

Main outcome measures: Number of follicles, serum E2, serum P, endometrial thickness, pregnancy rate (PR) and miscarriage rate.

Detailed description: No more details

Eligibility criteria: Inclusion Criteria:

* Diagnosis of PCOS based on the revised 2003 consensus on diagnostic criteria and long-term health risks related to PCOS (2003).
* All women were previously treated with 100 mg of CC daily for 5 days per cycle, for two to three cycles with persistent anovulation or ovulate with very thin endometrium \<5 mm at the time of hCG administration

Exclusion Criteria:

* patients with hyperprolactinaemia,
* hypercorticism and
* thyroid dysfunction.
* patients receiving medications as cholesterol lowering drugs, as statins, beta-blockers, and tricyclic antidepressants

Primary outcomes:
measure: Number of ovulating patients
timeFrame: 1-2 months
Secondary outcomes:
measure: Number of pregnancies
timeFrame: 1-2 months
Other outcomes:
measure: Number of miscarriages
timeFrame: 1 month
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospitals
state: Dakahlia
Study officials:
References:
citation: El Refaeey A, Selem A, Badawy A. Combined coenzyme Q10 and clomiphene citrate for ovulation induction in clomiphene-citrate-resistant polycystic ovary syndrome. Reprod Biomed Online. 2014 Jul;29(1):119-24. doi: 10.1016/j.rbmo.2014.03.011. Epub 2014 Mar 26.
Clinical trial NCT06078566: Long-Term Follow-Up Study of Unilateral Microtia Patients Implanted With AUR-201
Official title: Long-Term Follow-Up Study of Unilateral Microtia Patients Who Participated in Study AUR 201 05 and Had the AUR-201 Implant in Place at Final Visit (24 Weeks After the First Implantation Surgery)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Microtia
Lead sponsor: Auregen Biotherapeutics, SA
Sponsor class: INDUSTRY
First posted: 2023-10-12
Enrollment: 10
Sex: ALL
Minimum age (years): 8
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Long-term follow-up of unilateral microtia patients implanted with AUR-201.

Detailed description: Long-term follow-up study of unilateral microtia patients who participated in Study AUR-201-05 and had the AUR-201 implant in place at the final visit (24 weeks post-implantation).

Eligibility criteria: Inclusion Criteria:

1. Participated in Study AUR-201-05 and had the AUR-201 implant (auricle\* or auricle and wedge) in place at the Final Study Visit of Study AUR-201-05 (24 weeks after the first implantation surgery). \*If the Principal Investigator (PI) opted not to implant the wedge component beneath the auricle component and the subject has only the auricle in place at the Final Study Visit of Study AUR-201-05, the subject will be considered eligible under this inclusion criterion;
2. Subject or guardian signed the informed consent form (ICF).

Exclusion Criteria:

1. Any condition which, in the opinion of the PI, places the subject at unacceptable risk if he/she were to participate in the study.

Primary outcomes:
measure: Appearance/Long-Term Durability of the AUR-201 Implant
timeFrame: 72 weeks. The study starts at 24 weeks post implantation and ends at 96 weeks post implantation for a total of 72 weeks for this study.
measure: Incidence of Long Term Treatment-Emergent Adverse Events
timeFrame: 72 weeks. The study starts at 24 weeks post implantation and ends at 96 weeks post implantation for a total of 72 weeks for this study
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Romo Plastic Surgery
state: New York
Study officials:
affiliation: Romo Plastic Surgery
name: Thomas Romo, III, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01454466: Partial Posterior Hyaloidectomy in Macular Surgery
Official title: Partial Posterior Hyaloidectomy in Macular Surgery : A Modified Procedure of Vitrectomy to Prevent Retinal Break Related to Induction of a Posterior Vitreous Detachment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Retinal Break
Retinal Detachment
Keywords: prevention
retinal break
vitrectomy
partial posterior hyaloidectomy
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-10-19
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the effect of partial posterior hyaloidectomy on preventing iatrogenic retinal breaks related to induction of a posterior vitreous detachment

Detailed description: The induction of a posterior vitreous detachment (IPVD) during vitrectomy have been suggested as one of the etiologies of iatrogenic retinal break related to vitrectomy.The iatrogenic retinal breaks related to IPVD usually develop near or anterior to the equatorial region.

Thus, the investigators hypothesized that this complication could be prevented by restricting the extent of IPVD, and planned a modified procedure of vitrectomy in which the extent of IPVD and removal of vitreous cortex was restricted to about slightly beyond the margin of temporal major vascular arcade.

The investigators have termed this procedure, partial posterior hyaloidectomy. Unlike RRD or proliferative diabetic retinopathy, lesions are localized within the major vascular arcade in macular disorders so that macular disorders could be an eligible indication for this procedure.

Eligibility criteria: Inclusion Criteria:

* Cases of idiopathic ERM or idiopathic MH without evidence of PVD preoperatively

Exclusion Criteria:

* history of previous intraocular surgery

Primary outcomes:
measure: incidence of intraoperative and postoperative retinal break related to surgery
timeFrame: postoperative 3 to 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Samsung Medical Center
name: Se Woong Kang, M.D.
role: STUDY_CHAIR
affiliation: Samsung Medical Center
name: Jae Hui Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01892566: Using Mobile Health to Respond Early to Acute Exacerbations of COPD in HIV
Official title: Using mHealth to Respond Early to Acute Exacerbations of COPD in HIV (mREACH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COPD
COPD Exacerbation
Keywords: HIV
mobile health
spirometry
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2013-07-04
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Investigators propose to develop methods to improve early identification of acute exacerbations of COPD (AECOPD) among HIV-infected individuals. Investigators hypothesize that earlier identification of acute exacerbations through in-home monitoring of respiratory symptoms, lung function and medication usage will allow appropriate intervention to reduce the morbidity associated with AECOPD. Therefore, the investigators propose using innovative mobile health (mHealth) applications to Respond Early to Acute exacerbations of COPD in HIV (mREACH). COPD is a co-morbidity of HIV with growing recognition, but remains greatly under-recognized among HIV-infected persons. In this application, among HIV-infected individuals with spirometry-confirmed COPD, investigators will conduct a pilot randomized trial of mHealth monitoring compared to usual care to reduce the symptom and clinical burden of AECOPD.


Eligibility criteria: Inclusion Criteria:

* HIV infected
* Has an established longitudinal care provider in Baltimore, MD
* Confirmed COPD defined as post-bronchodilator FEV1/FVC\<0.70
* Stable residence for duration of 6 month intervention

Exclusion Criteria:

* Age \< 18 years
* Unable/unwilling to provide informed consent
* Failure to present to randomization visit

Primary outcomes:
measure: composite clinical outcome of any COPD-related ER visit or hospitalization
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins ALIVE Clinic
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Gregory Kirk, MD MHS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03550066: Patients Engaged in Prevention: Enhancing Outreach to Increase Patient Engagement in Diabetes Prevention
Official title: A Self-Affirmation Intervention to Enhance Patient Outreach for Health System-based Lifestyle Programs for Diabetes Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preventive Health Services
Health Communication
Keywords: Diabetes, gestational
Diabetes Mellitus
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2018-06-08
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study examines whether a health message that includes a self-affirmation intervention (where people reflect on values that are important to them) increases acceptance of the message and encourages people to take steps to prevent diabetes, as compared to a health message without the self affirmation intervention.

Detailed description: Background: Despite availability of evidence-based programs for diabetes prevention, few strategies exist to promote patients' interest in them. Strategies should be developed for racial/ethnic minority women with a history of gestational diabetes (GDM), who face exceptionally high risk for chronic diabetes. We previously found that a theory-based outreach message containing a streamlined values affirmation-two sentences prompting individuals to reflect on core personal values-increased women's likelihood of demonstrating interest in a preventive program. Extending this work, this pilot trial tests whether the values affirmation outreach message is as acceptable as (non-inferior to) a standard outreach message among African-American and Latina women.

Methods: Two-arm, parallel-group, randomized trial among English- and Spanish-speaking minority women with prior GDM and overweight/obesity in a healthcare system. Within an online survey, participants are randomized to read an outreach message promoting an existing preventive program. The message contains either a values affirmation (intervention condition) or no affirmation (control condition).

Eligibility criteria: Inclusion Criteria:

* History of gestational diabetes
* Body mass index ≥25 kg/m2
* English or Spanish language

Exclusion Criteria:

* Current diabetes
* Current pregnancy

Primary outcomes:
measure: Acceptance of Health Message
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: Diabetes Prevention Behavior: Information Seeking
timeFrame: Up to 2 weeks
measure: Diabetes Prevention Behavior: Intention
timeFrame: Up to 2 weeks
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Northern California
state: California
Study officials:
affiliation: Kaiser Permanente
name: Susan D Brown, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01276366: Amphia Premature Infant Pain Study
Official title: Amphia Premature Infant Pain Study; Breast Milk vs Sucrose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Infant
Breast Feeding, Exclusive
Puncture Skin
Keywords: Heel lance
Premature
Breast milk
Lead sponsor: Amphia Hospital
Sponsor class: OTHER
First posted: 2011-01-13
Enrollment: 75
Sex: ALL
Minimum age (years): 1
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Last thirty years, many research was performed concerning pain in the newborn. These investigations showed us the negative effects of pain in the neonatal period. Our research concerns the choice of analgesics for the premature newborn during a heel lance. Newborns with a gestational age of 32-37 weeks are randomly assigned over three groups. They can receive breastfeeding, during the heel lance, a bottle with supplemental breast milk or sucrose.

The primary objective of the Amphia Premature Infant Pain study, is to investigate whether there is a difference in PIPP-scores in premature newborns who undergo a heel lance, receiving breast milk or sucrose. Our hypothesis is that the PIPP-score will be lower in newborns receiving breast milk compared to sucrose. And the investigators presume that breast feeding has the same analgesic effect as giving supplemental breast milk.


Eligibility criteria: Inclusion Criteria:

* born at a gestational age between 32+0 and 36+6 weeks,
* being nourished with breast milk
* the necessity for a clinical blood sample.

Exclusion Criteria:

* perinatal asphyxia,
* birth trauma,
* condition of cardio-respiratory instability,
* condition of serious nutritional problems with clinical evidence of gastro oesophageal reflux disease,
* drug abuse of the mother
* and application of sedative medication to mother or child.

Primary outcomes:
measure: Pain scores assessed by the PIPP score
timeFrame: The PIPP score will be assessed during a heellance. This heellance will be performed after one day of life and before two months.
Secondary outcomes:
measure: Pain score assessed by the COMFORTneo score
timeFrame: The COMFORTneo score will be assessed during a heellance. This heellance will be performed after one day of life and before two months.
measure: partial correlation between the two pain assessment tools.
timeFrame: up to 2 years
measure: intra-class correlation coefficient
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Breda
country: Netherlands
facility: Amphia Hospital
state: Noord Brabant
Study officials:
affiliation: Amphia Hospital Breda
name: RHT v Beek, phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Simonse E, Mulder PG, van Beek RH. Analgesic effect of breast milk versus sucrose for analgesia during heel lance in late preterm infants. Pediatrics. 2012 Apr;129(4):657-63. doi: 10.1542/peds.2011-2173. Epub 2012 Mar 5.
Clinical trial NCT03323866: Mometasone vs Budesonide in CRS With Polyposis
Official title: Randomized Controled Double-blinded Study Comparing Mometasone Nasal Spray to Budesonide Irrigations in Patients With Chronic Rhinosinusitis With Nasal Polyposis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Rhinosinusitis (Diagnosis), Nasal Polyposis
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial comparing mometasone nasal spray to budesonide irrigations for treatment of chronic rhinosinusitis with nasal polyposis
Primary purpose: TREATMENT

Brief summary: The principal objective is to compare the use of mometasone nasal spray to budesonide irrigations in patients suffering from CRSwNP who have never been operated.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of chronic rhinosinusitis with nasal polyps
* Absence of active infection at start of study

Exclusion Criteria:

* Diagnosis of chronic rhinosinusitis without nasal polyps
* Diagnosis of recurrent acute bacterial rhinosinusitis
* Previous sinus surgery (septal of inferior turbinate surgeries are not considered sinus surgeries)
* Cystic fibrosis or ciliary dyskinesia
* Allergy to corticosteroids
* Pregnant or lactating women
* Contra-indication to intranasal steroids

Primary outcomes:
measure: Disease specific quality of life questionnaire
timeFrame: 3 months after beginning of treatment
Secondary outcomes:
measure: Endoscopic evaluation of the nasal cavities
timeFrame: 3 months after beginning of treatment
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Université de Sherbrooke
state: Quebec
Study officials:
References:
Clinical trial NCT04336566: Renal Effects of Melatonin Trial in Chronic Kidney Disease
Official title: Renal Function in Chronic Kidney Disease and the Effect of Exogenous Melatonin Administration (REM TRIAL)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Keywords: Chronic Kidney Disease
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This will be a prospective, double blinded, randomized, controlled pilot study to determine if there is any correlation between melatonin administration and proteinuria.

Detailed description: Investigators plan to enroll up to 100 eligible participants in this pilot trial with 50 participants randomized to receive melatonin and 50 patients randomized to receive a placebo. Participants will be randomized on a rolling basis; meaning, once participants agree to enroll in the study, the participant will be placed randomly into either group.

Eligibility criteria: Inclusion Criteria:

* Are between ages 18 and up with chronic kidney disease (CKD) I-III (stage 3 kidney disease, kidney dysfunction)
* Random urine microalbumin of 30 mcg or greater (protein in the urine)
* Have ability to complete a sleep survey
* Currently not on melatonin therapy.

Exclusion Criteria:

* End Stage Renal Disease
* CKD Stage IV (stage 4 with severe kidney dysfunction)
* Severe liver disease
* Chronic dialysis therapy

Primary outcomes:
measure: Change in Albuminuria
timeFrame: 6 months
Secondary outcomes:
measure: Surveys including Pittsburgh Sleep Quality Index (PSQI) questionnaire
timeFrame: 6 months
measure: Sodium levels
timeFrame: 6 months
measure: Urinalysis
timeFrame: 6 months
measure: Creatinine levels
timeFrame: 6 months
measure: Blood Urea Nitrogen (BUN) levels
timeFrame: 6 months
measure: Potassium levels
timeFrame: 6 months
measure: Bicarbonate levels
timeFrame: 6 months
measure: Chloride levels
timeFrame: 6 months
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: University of Oklahoma School of Community Medicine
state: Oklahoma
Study officials:
affiliation: OUHSC
name: Krishna M Baradhi, MD
role: PRINCIPAL_INVESTIGATOR
References: