louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03536715: Qualitative Validation of Patient-Reported Outcomes (PRO) Instrument
Official title: Qualitative Patient Interviews to Develop a Patient-Reported Outcomes (PRO) Instrument to Assess Visual Symptoms in KAMRA® Inlay Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient-Reported Outcomes (PRO)
Lead sponsor: AcuFocus, Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-25
Enrollment: 22
Sex: ALL
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The sample recruited will reflect the target KAMRA inlay patient population. Thus, a minimum of 20 subjects (up to 50 subjects to achieve saturation) who have been implanted with the KAMRA inlay will be recruited from up to 5 sites across the US. Subjects with a range of post-operative experience, satisfaction, visual symptoms, ages and educational abilities will be recruited. In addition, subjects who are of non Caucasian ethnicity will be included.

Brief summary: The purpose of this study is to conduct concept elicitation and cognitive debriefing interviews with patients who have been implanted with the KAMRA inlay in order to assess the content validity of a PRO instrument


Eligibility criteria: Inclusion Criteria:

1. Minimum 45 years of age, maximum age 60 years;
2. Subject has been implanted with the KAMRA inlay;
3. Subject is in good general health, as evidenced by medical history;
4. Subject is willing and able to attend and participate in the interviews and demographic questionnaire (fluent in U.S. English); and
5. Signed informed consent document.

Exclusion Criteria:

1. Subject has severe neurological or cognitive deficits or an uncontrolled psychiatric condition that might affect their ability to participate in the interview;
2. Subject has insufficient ability to read or write that would prevent them from completing a questionnaire without help;
3. Subject is not a fluent speaker of U.S. English; or
4. Subject is unable to attend the interview.

Primary outcomes:
measure: PRO instrument
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03397615: Effect of Vaginal Douching With Betadine Before CS for Prevention of Post Operative Infections
Official title: Effect of Vaginal Douching With Betadine Versus Non Douching Before CS for Prevention of Post Operative Infections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Puerperal Infection
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-01-12
Enrollment: 1200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The present study was a prospective randomized controlled trial in which subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery or received no vaginal preparation

Detailed description: The present study was a prospective randomized controlled trial in which subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery or received no vaginal preparation

Eligibility criteria: Inclusion Criteria:

* Any patient undergoing CS

Exclusion Criteria:

* • Betadine allegy.

  * Rupture membranes.
  * Accidental Hemorrhage.
  * H/O suggestive chorioamnionitis ; uterine tenderness, offensive vaginal discharge, fever medical disorders as diabetes, hypertension , cardiac or renal diseqases

Primary outcomes:
measure: Postpartum endometritis
timeFrame: 6 weeks after Cesarean section
Secondary outcomes:
measure: Postoperative wound infection
timeFrame: 6 weeks after Cesarean section
measure: Postoperative fever
timeFrame: 3 weeks after Cesarean section
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Professor
name: Ahmed Maged, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Haas DM, Morgan S, Contreras K, Kimball S. Vaginal preparation with antiseptic solution before cesarean section for preventing postoperative infections. Cochrane Database Syst Rev. 2020 Apr 26;4(4):CD007892. doi: 10.1002/14651858.CD007892.pub7.
Clinical trial NCT05961215: Scalp Cooling to Prevent Hair Loss in Patients Undergoing Stem Cell Transplantation for Multiple Myeloma
Official title: IIT2023-03-Vescio-ColdCap: Scalp Cooling to Prevent Hair Loss in Patients Undergoing Stem Cell Transplantation for Multiple Myeloma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Myeloma
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
Collaborators: name: Penguin Cold Caps
First posted: 2023-07-27
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This pilot study of scalp cooling with Penguin cold caps will examine the effectiveness of scalp cooling to reduce the development of hair loss in 30 participants with multiple myeloma undergoing high-dose chemotherapy with melphalan and autologous peripheral blood stem cell transplant at Cedars-Sinai Medical Center. The investigators will also assess the potential impact of hair loss versus the discomfort and inconvenience of the scalp cooling procedure.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* ECOG performance status ≤2
* Confirmed multiple myeloma diagnosis
* Hair covering ≥75% of scalp on physical exam at screening visit
* Planning to undergo SOC high-dose chemotherapy with melphalan (dose to be used = 140 - 200 mg/m2 (with rounding per CSMC guidelines)) followed by an autologous peripheral blood stem cell transplant.
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

* Prior or current use of any scalp cooling treatment
* Hair covering \< 75% of the scalp on physical exam at screening visit.
* Medical History and Concurrent Diseases: Reynaud's disease, Cold sensitivity, Cold agglutinin disease, Cryoglobulinemia, Cryofibrinogenemia
* Current spinal or neck injury that may interfere with the subject's participation for the full duration of the study, in the opinion of the treating investigator
* Skin conditions such as psoriasis, eczema, malignancy, or other condition on the scalp that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
* Current use of oxaliplatin
* Current use of any other investigational agents
* Contraindication to melphalan

Primary outcomes:
measure: Change in development of hair loss
timeFrame: From the start of study treatment (Day -2) until Day 30.
Secondary outcomes:
measure: Patient determined decision of scalp cooling benefit
timeFrame: At Day 0 and Day 90.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Robert Vescio, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00243815: Use of Ibuprofen to Prevent IUD Site Effects
Official title: Prophylactic Ibuprofen: Effect on IUD Continuation Rates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: IUD Removal
Keywords: randomized controlled trial
prophylactic nonsteroidal antiflammatory drug
IUD removal
Lead sponsor: FHI 360
Sponsor class: OTHER
Collaborators: name: Chilean Institute of Reproductive Medicine
name: Ministry of Health, Chile
First posted: 2005-10-25
Enrollment: 2019
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This research will determine whether prophylactic use of ibuprofen can prevent common side effects of the copper intrauterine device (IUD) and prevent early removal of the device.

Detailed description: Increased menstrual bleeding and pain are the primary side effects that lead to early removal of the copper intrauterine device (IUD). Ibuprofen and other nonsteroidal anti-inflammatory drugs are a proven treatment for such IUD-induced problems. This study will determine if prophylactic use of ibuprofen can improve continuation rates of the IUD.

A total of 2,019 first-time IUD users were recruited in Chile for this double-blind, randomized, placebo-controlled trial. Half of the participants were given ibuprofen and instructions to take 1200 mg daily during menses (for up to 5 days each cycle) for the first six months of IUD use. The other half were asked to take an identical-appearing placebo in the same manner. The primary study endpoint was IUD removal within 12 months of insertion.

Eligibility criteria: Inclusion Criteria:

* mutually monogamous sexual relationship, less than 6 weeks since last menstrual period, more than six weeks since last pregnancy ended, residency within 50km of clinic, access to telephone, literacy

Exclusion Criteria:

* previous use of an IUD, history of liver and/or kidney disease, current of non-steroidal anti-inflammatory drugs, history of stomach ulcers and/or digestive hemorrhage, previous adverse reaction to ibuprofen and/or aspirin, symptoms of possible vaginal infection, current use of antibiotic or antifungal for genital tract infection, abnormal vaginal discharge, lesions in the vagina, known contraindication to IUD use, more than 3 alcoholic drinks per day

Primary outcomes:
measure: IUD removal
Secondary outcomes:
measure: Incidence of IUD side effects
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: 43 Ministry of Health facilities
Study officials:
affiliation: FHI 360
name: David Hubacher, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01344915: Restricted vs. Free Knee Range Of Motion For Primary Traumatic Patellar Dislocation
Official title: RESTRICTED VS. FREE KNEE RANGE OF MOTION FOR PRIMARY TRAUMATIC PATELLAR DISLOCATION: A PROSPECTIVE RANDOMIZED STUDY
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patellar Dislocation
Keywords: Patella
Knee
Brace
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2011-04-29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Knee immobilization in near extension has been proposed as a nonoperative treatment for primary traumatic patellar dislocation, although there exist no prospective studies regarding the method of immobilization. The objective of this prospective randomized study was to compare the clinical outcome after nonoperative treatment with restricted vs. free range of motion (ROM) for primary traumatic patellar dislocation.


Eligibility criteria: Inclusion Criteria:

* A primary (first-time) patellar dislocation verified by clinical examination
* Signs of patellar dislocation in MRI

Exclusion Criteria:

* anyone with previous patellar instability
* osteochondral fracture requiring surgery
* associated knee injuries

Primary outcomes:
measure: Patellar redislocation
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital, Department of Orthopaedic Surgery
name: Petri J Sillanpää, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Honkonen EE, Sillanpaa PJ, Reito A, Maenpaa H, Mattila VM. A Randomized Controlled Trial Comparing a Patella-Stabilizing, Motion-Restricting Knee Brace Versus a Neoprene Nonhinged Knee Brace After a First-Time Traumatic Patellar Dislocation. Am J Sports Med. 2022 Jun;50(7):1867-1875. doi: 10.1177/03635465221090644. Epub 2022 Apr 19.
Clinical trial NCT01233115: LOC387715/HTRA1 and the Combined Photodynamic Therapy With Intravitreal Bevacizumab in Polypoidal Choroidal Vasculopathy
Official title: LOC387715/HTRA1 Variants and the Response to Combined Photodynamic Therapy With Intravitreal Bevacizumab in Polypoidal Choroidal Vasculopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-Related Macular Degeneration
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2010-11-03
Enrollment: 70
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The authors did a retrospective chart review of 70 patients with PCV who were treated at the Department of Ophthalmology, Kyungpook National University Hospital in Daegu, Korea.

Brief summary: This study is to investigate whether there is an association of the LOC387715/HTRA1 variants with response to treatment with combined photodynamic therapy and intravitreal bevacizumab for patients with polypoidal choroidal vasculopathy.

Detailed description: This is a retrospective cohort study comprised of 70 eyes being treated for polypoidal choroidal vasculopathy with combined photodynamic therapy and intravitreal bevacizumab injections. Patients were genotyped for the LOC387715 (rs10490924) and the HTRA1 gene polymorphism (rs11200638).

Eligibility criteria: Inclusion Criteria:

* patients older than 60 years of age at onset
* polyp-like terminal aneurysmal dilations with or without branching vascular networks in indocyanine green angiography (ICGA) and subretinal reddish-orange protrusions corresponding to polyp-like lesions
* patients who had combined photodynamic therapy and intravitreal bevacizumab injections, and followed up for more than 12 months after the first treatment

Exclusion Criteria:

* patients with retinal or choroidal diseases including pathologic myopia, angioid streaks, idiopathic choroidal neovascularization (CNV), presumed ocular histoplasmosis, and other secondary CNV
* patients who refused genotypic analyses

Primary outcomes:
measure: Best-corrected visual acuity
timeFrame: up to 12 months
Secondary outcomes:
measure: Angiographic characteristics
timeFrame: up to 12 months
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: In Taek Kim
state: Kyungsangpookdo
Study officials:
affiliation: Kyungpook National University Hospital
name: In Taek Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sakurada Y, Kubota T, Imasawa M, Mabuchi F, Tanabe N, Iijima H. Association of LOC387715 A69S genotype with visual prognosis after photodynamic therapy for polypoidal choroidal vasculopathy. Retina. 2010 Nov-Dec;30(10):1616-21. doi: 10.1097/IAE.0b013e3181e587e3.
Clinical trial NCT01565915: Efficacy and Safety of Perlane-L in the Correction of Midface Volume Deficit
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Facial Volume
Lead sponsor: Medicis Global Service Corporation
Sponsor class: INDUSTRY
First posted: 2012-03-29
Enrollment: 221
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: The purpose of this study is to determine if Perlane-L is safe in increasing cheek volume.


Eligibility criteria: Inclusion Criteria:

* Loss of Fullness in Midface Area
* Other items as identified in the protocol

Exclusion Criteria:

* History of allergy or hypersensitivity to injectable hyaluronic acid gel or lidocaine.
* Other items as identified in the protocol

Primary outcomes:
measure: Facial fullness using midface scale
timeFrame: Week 8
Secondary outcomes:
measure: Facial fullness using the midface scale
timeFrame: Up to 12-months post treatment
measure: Subject satisfaction using the GAIS
timeFrame: Up to 12-months post treatment
measure: Aesthetic improvement
timeFrame: Up to 12-months post treatment
Other outcomes:
Locations:
city: Beverly Hills
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Vista
country: United States
state: California
city: Aventura
country: United States
state: Florida
city: Coral Gables
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Hunt Valley
country: United States
state: Maryland
city: Chestnut Hill
country: United States
state: Massachusetts
city: Mount Kisco
country: United States
state: New York
city: New York
country: United States
state: New York
city: Eugene
country: United States
state: Oregon
Study officials:
References:
Clinical trial NCT03137615: The Cardiovascular Changes Associated With Septal Local Anaesthesia
Official title: An Observational Study of the Cardiovascular Response to Infiltration of Local Anaesthetic Into the Nasal Septum in Patients Undergoing Trans-sphenoidal Resection of a Pituitary Lesion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypothalamic Neoplasms
Pituitary Diseases
Anesthesia, Local
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2017-05-03
Enrollment: 15
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing trans-sphenoidal resection of a pituitary tumour.

Brief summary: The purpose of this study is to determine the effects on the heart of injecting local anaesthetic into the nose prior to surgery on the pituitary gland?

Detailed description: People sometimes require surgery on their pituitary gland. This is a gland at the base of your brain which secretes hormones. At the Royal Hallamshire Hospital the investigators are currently conducting a study into the effects of local anaesthetic (a medicine which causes numbness) injection on patients undergoing this particular type of operation.

After patients are anaesthetised (asleep) but before surgery starts the surgeon injecst a local anaesthetic solution into the nose. This is routine practice and is done to provide pain relief afterwards and also to decrease the amount of bleeding during the operation to ensure that the surgeon has a good view.

The investigators have known for a long time that local anaesthetic affects the heart rate and blood pressure, however the investigators would like to describe exactly how, in much more detail.

Eligibility criteria: Inclusion Criteria:

* Any adult patient undergoing trans-sphenoidal pituitary surgery.

Exclusion Criteria:

* Under 16 years of age, pregnancy, uncontrolled hypertension, allergy to any local anaesthetic, patient refusal or revision pituitary surgery.

Primary outcomes:
measure: Change in blood pressure after administration of local anaesthesia
timeFrame: 5 minutes
Secondary outcomes:
measure: Change in heart rate after administration of local anaesthesia
timeFrame: 5 minutes
measure: Change in cardiac output after administration of local anaesthesia
timeFrame: 5 minutes
measure: Change in systemic vascular resistance after administration of local anaesthesia
timeFrame: 5 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: Matthew D Wiles, FRCA FFICM
role: STUDY_CHAIR
References:
Clinical trial NCT00710515: Study to Assess the Effect of Dosing AZD6244 HydSulfate in the Presence and Absence of Food in Patients With Advanced Solid Malignancies
Official title: A Phase I, Open-Label Study to Assess the Effect of Dosing AZD6244 HydSulfate in the Presence and Absence of Food in Patients With Advanced Solid Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Melanoma
Malignant Melanoma
Keywords: Melanoma
Phase I
AZD6244
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-07-04
Enrollment: 30
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: The purpose of this study is to test if the levels of AZD6244 in blood are affected by taking food at the same time as the capsules compared to taking capsules on an empty stomach


Eligibility criteria: Inclusion Criteria:

* Able to eat a high fat breakfast within a 30-minute period
* Advanced cancer which is refractory to standard therapies, for which no standard therapies exist
* WHO or ECOG performance status 0-2 (those with performance status 2 must have been stable with no deterioration for over 2 weeks)

Exclusion Criteria:

* Any radiotherapy or chemotherapy within 21 days prior to starting the study treatment (not including palliative radiotherapy at focal sites).
* Any evidence of severe or uncontrolled systemic disease (eg., severe hepatic impairment, severe renal impairment, uncontrolled diabetes, acute uncontrolled infection) or current unstable or uncompensated respiratory or cardiac conditions or peripheral vascular disease including diabetic vasculopathy.
* Refractory nausea and vomiting, chronic GI diseases (eg., inflammatory bowel disease) or significant bowel resection that would preclude adequate absorption.

Primary outcomes:
measure: To assess whether food influences the rate and extent of AZD6244 absorption
timeFrame: Day 1 and Day 10
Secondary outcomes:
measure: To determine the pharmacokinetics of both AZD6244 and N-desmethyl AZD6244 in the presence and absence of food
timeFrame: Day 1, 2, 3, 8, 9, and 10
measure: To assess the safety and tolerability of AZD6244 in patients with advanced solid malignancies
timeFrame: screening to 30 day post last dose
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Research Site
city: Maastricht
country: Netherlands
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Headington
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Oxford
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Rajesh Chopra
role: STUDY_DIRECTOR
affiliation: Maastricht
name: Jan Schellens
role: PRINCIPAL_INVESTIGATOR
References: