louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02175199: A Comparison of Two Color Contact Lenses in Habitual Clear Contact Lens Wearers
Official title: A Comparison of Two Color Contact Lenses in Habitual Clear Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: Contact lens
Vision care
Daily wear
Color contact lens
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2014-06-26
Enrollment: 151
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate the comfort of color contact lenses in a population of clear contact lens wearers who have an interest in wearing color contact lenses.


Eligibility criteria: Inclusion Criteria:

* Willing to sign an Informed Consent Document or Assent, if applicable.
* Vision correctable to 20/30 Snellen (feet) or better in each eye at distance with pre-study contact lenses.
* Manifest cylinder (at screening) less than or equal to 0.75 diopters (D) in each eye.
* Successful wear of clear/handling tint, single-vision spherical, bi-weekly/ monthly replacement soft contact lenses in both eyes during the past 2 months for a minimum of 5 days per week and 8 hours per day.
* Requires spherical contact lenses within the available range of powers (i.e.,-1.50D to -5.00D in 0.25D steps).
* Interested in wearing contact lenses that change the appearance of the color of the eyes.
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Any anterior segment infection, inflammation, disease or abnormality that contraindicates contact lens wear (within 7 days of enrollment, or current).
* History of herpetic keratitis.
* Any use of systemic or ocular medications for which contact lens wear could be contraindicated including any use of topical ocular medications that would require instillation during contact lens wear, except for rewetting drops.
* Corneal vascularization greater than 1 millimeter (mm) of penetration.
* Habitual lenses worn in an extended wear modality (routinely sleeping in lenses overnight for 1 night per week or more) over the last 3 months prior to enrollment.
* Previous corneal or refractive surgery or irregular cornea.
* Monovision and monocular (only 1 eye with functional vision) or fit with only 1 lens.
* Anisometropia ≥1.50D (study contact lens prescription).
* History of intolerance or hypersensitivity to any component of the test articles.
* Eye injury or ocular or intra-ocular surgery within the last 6 months (excluding placement of punctal plugs).
* Participation in any clinical study within 30 days of Visit 1.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Lens Comfort Likert Response at Day 30
timeFrame: Day 30
Secondary outcomes:
measure: Lens Comfort Likert Response at Day 14
timeFrame: Day 14
measure: Lens Comfort 1-10 Scale Response
timeFrame: Day 30
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Global Brand Lead, GCRA, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT06484699: Open Versus Laparoscopic Repair of Perforated Peptic Ulcer
Official title: Open Versus Laparoscopic Repair of Perforated Peptic Ulcer in Sohag
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perforated Peptic Ulcer
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this clinical trial is to compare the outcomes of open versus laparoscopic repair for perforated peptic ulcer and provide evidence-based guidance to the selection of the most appropriate operative technique at Sohag University Hospital. The study will include patients presented with perforated peptic ulcers as a complication of peptic ulcer disease during the period of study.


Eligibility criteria: Inclusion Criteria:

* All patients with a clinical diagnosis of perforated peptic ulcer that are fit to undergo surgery either via laparotomy or laparoscopy, males or females, any age, with gastric or duodenal ulcer, with American Society of Anesthesiologists (ASA) grade I, II, III.

Exclusion Criteria:

* Patients with associated bleeding ulcer (additional steps are needed to control bleeding).
* Patients with associated pathology other than perforated peptic ulcer.
* Patients with American Society of Anesthesiologists (ASA) grade IV, V, VI.

Primary outcomes:
measure: Early postoperative follow up for repair of perforated peptic ulcer
timeFrame: 3 days after the operation
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University Hospital
Study officials:
References:
citation: Lanas A, Chan FKL. Peptic ulcer disease. Lancet. 2017 Aug 5;390(10094):613-624. doi: 10.1016/S0140-6736(16)32404-7. Epub 2017 Feb 25.
citation: Tarasconi A, Coccolini F, Biffl WL, Tomasoni M, Ansaloni L, Picetti E, Molfino S, Shelat V, Cimbanassi S, Weber DG, Abu-Zidan FM, Campanile FC, Di Saverio S, Baiocchi GL, Casella C, Kelly MD, Kirkpatrick AW, Leppaniemi A, Moore EE, Peitzman A, Fraga GP, Ceresoli M, Maier RV, Wani I, Pattonieri V, Perrone G, Velmahos G, Sugrue M, Sartelli M, Kluger Y, Catena F. Perforated and bleeding peptic ulcer: WSES guidelines. World J Emerg Surg. 2020 Jan 7;15:3. doi: 10.1186/s13017-019-0283-9. eCollection 2020.
citation: Lau JY, Sung J, Hill C, Henderson C, Howden CW, Metz DC. Systematic review of the epidemiology of complicated peptic ulcer disease: incidence, recurrence, risk factors and mortality. Digestion. 2011;84(2):102-13. doi: 10.1159/000323958. Epub 2011 Apr 14.
Clinical trial NCT02975999: Use of Vasopressin Following the Fontan Operation
Official title: Use of Vasopressin Following the Fontan Operation: Both Pilot and Multicenter Studies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Pleural Effusion
Single-ventricle
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2016-11-29
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study is to prepare for a larger study to determine whether Vasopressin following the Fontan operation will decrease chest tube output and duration.

Detailed description: A pilot randomized, double blinded clinical trial to evaluate the use of vasopressin following the Fontan operation.

Phase one of the study will be a single center pilot study and will be conducted at Advocate Children's Hospital, Oak Lawn IL. This will be a randomized and double blinded. Ten patients will be enrolled with five patients as control group and five receiving Vasopressin. Vasopressin levels will be obtained just prior to initiation of Vasopressin and 48 hours later in the pilot study. Safety and effect size will be evaluated after this pilot study.

Drug administration protocol:

Vasopressin at a dose of 0.4 mU/kg/min will be started on subjects in the study group while coming off cardiopulmonary bypass. The dose of Vasopressin will not be titrated. Study drug drip will infuse for 48 hours after which will be discontinued.

The placebo group will be receiving normal saline at the same rate of the vasopressin group. The treating physician will be blinded.

Eligibility criteria: Inclusion Criteria:

* Subjects between 1.5-7 years old undergoing Fontan operation.

Exclusion Criteria:

* Patients with a planned fenestrated Fontan.
* Patients undergoing revision surgery for failing Fontan.
* Evidence of renal insufficiency prior to surgery defined by creatinine \>1 mg/dl.
* Planned arch reconstruction at the time of the Fontan procedure

Primary outcomes:
measure: Chest Tube Drainage
timeFrame: From post operative day 0 through study completion, an average of 1 month
Secondary outcomes:
measure: Length of Hospital Stay
timeFrame: From the day of the surgery (post operative day 0) through study completion, an average of 1 month
Other outcomes:
Locations:
city: Oak Lawn
country: United States
facility: Advocate Children's Hospital
state: Illinois
Study officials:
affiliation: Advocate Health
name: Jamie Penk, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03885999: Studies in Patients With Low Anterior Resection Syndrome (LARS)
Official title: Functional Anorectal Studies in Patients With Low Anterior Resection Syndrome (LARS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Resection Syndrome
Bowel Dysfunction
Lead sponsor: Giome
Sponsor class: OTHER
First posted: 2019-03-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Colorectal Cancer is the commonest cancer diagnosed for both genders combined in Hong Kong. In 2015 16.6% of all new cancer cases registered on the Hong Kong registry were cancer of colon and rectum. With recent development in oncological and surgical treatments for rectal cancer, many patients are receiving sphincter-preserving surgery with low colorectal or coloanal anastomosis to avoid permanent stoma.

Up to 80% of patients who has undergone low anterior resection (LAR), suffer from severe bowel dysfunction post operatively. Patients may suffer from a wide range of symptoms from incontinence, frequency, and urgency to constipation and feelings of incomplete emptying. This combination of symptoms after LAR is referred to as Low Anterior Resection Syndrome (LARS) which is associated with negative impact on quality of life (QoL). Originally, it was thought that these symptoms were due to early postoperative changes. Many studies report that the majority of patients experience longterm changes in quality of life after LAR. Therefore, a large number of patients worldwide are suffering from unpredictable, poor bowel function postoperatively affecting their day-to-day activity and quality of life. The cause of LARS is often multifactorial and difficult to define. Unfortunately, there is no cure for LARS at present. This trial is designed to use Fecobionics, a new Hong Kong based innovation of a simulated stool, to provide new mechanistic insights regarding anorectal physiological function post low anterior resection to understand the condition better to improve their treatment options.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older with history of LARS over 3 months.
* Informed, written consent by the patient

Exclusion Criteria:

* Patients who are not willing to undergo the specified tests in this study
* Pregnant women

Primary outcomes:
measure: Change of Anorectal Pressure Assessed With the Fecobionics Device
timeFrame: baseline and following intervention, approximately 30 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Department of Surgery, Prince of Wales Hospital
Study officials:
References:
Clinical trial NCT00842699: Characterization of Immunological Profile of Renal Transplant Patients Undergoing Induction Treatment With Thymoglobulin vs. IL-2 Receptor Antagonist Basiliximab
Official title: Characterization of Immunological Profile of Renal Transplant Patients Undergoing Induction Treatment With Thymoglobulin vs. IL-2 Receptor Antagonist Basiliximab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Transplantation
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
First posted: 2009-02-12
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: renal transplant recipients and living donors if available

Brief summary: The goal of the study is to find out the effects of two different drugs used at the beginning of organ transplantation on different populations of immune cells in the body of patients.


Eligibility criteria: Inclusion Criteria:

* all patients considered for transplantation

Exclusion Criteria:

* none

Primary outcomes:
measure: The primary outcome is to look for expansion of regulatory T cells at one year.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Nader Najafian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05091099: The Optimal Sequential Therapy After Long Term Denosumab Treatment
Official title: The Optimal Sequential Therapy After Long Term Denosumab Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Osteoporosis
Keywords: Osteoporosis
denosumab
alendronate
zoledronic acid
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2021-10-25
Enrollment: 44
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One arm accept on time zoledronic acid after long-tearm denosumab. Another arm accept alendronate for 4 months and then zoledronic acid after long-tearm denosumab.
Primary purpose: TREATMENT

Brief summary: This study intends to investigate whether Alendronate and Zoledronate can prevent bone mineral density loss after long-term treatment with Denosumab.

Detailed description: This study intends to use a randomized trial to test whether Alendronate and Zoledronate can avoid the risk of rapid bone loss after the withdrawal of Denosumab.

Eligibility criteria: Inclusion Criteria:

1. Postmenopausal women or men over 50 years old
2. Denosumab treatment for at least two years and less than three years (up to five doses).

Exclusion Criteria:

1. Estimated glomerular filtration rate \<35 ml/min.
2. Malignancy
3. Continuous steroid treatment, hormone therapy or other medical treatment affecting bone metabolism
4. Secondary osteoporosis
5. Metabolic bone diseases
6. Contraindications to ZOL
7. Patients older than 80 years old
8. Hypocalcemia

Primary outcomes:
measure: Bone mineral density of lumbar spine
timeFrame: one year
Secondary outcomes:
measure: Bone mineral density of femoral neck
timeFrame: one year
measure: Bone mineral density of total hip
timeFrame: one year
Other outcomes:
Locations:
city: Douliu
country: Taiwan
facility: National Taiwan University Hospital, Yunlin branch
state: Yunlin County
Study officials:
References:
Clinical trial NCT00174499: A Pilot Drug Trial That Evaluates the Whitening Potential of Nicotine Gum
Official title: An Open-label Study on Nicorette Freshmint Gum, 2 MG AND 4 MG in Smokers With Visible Teeth Staining Motivated to Quit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Pellicle
Keywords: Tooth stain
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this research study is to evaluate the effects on existing tooth stain of nicotine gum. The study will enroll adults who have visible tooth staining.

Detailed description: This was a 6-week, open-label, single-center study conducted in 78 subjects who were smokers with visible staining of teeth and who were motivated to quit smoking through use of Nicorette Freshmint gum.

The subjects were assigned, per label instructions, to either Nicorette Freshmint gum 2 mg or 4 mg based on the number of cigarettes smoked per day. Subjects who smoked at least 25 or more cigarettes per day were assigned to the 4 mg gum group; those who smoked less than 25 cigarettes per day were assigned to the 2 mg gum group.

A total of 3 study visits were planned: Screening/Baseline, Week 2 and Week 6. A telephone screening prior to Baseline and the Screening/Baseline visit was performed to confirm subject eligibility. At each visit an oral examination, including a stain index measurement used to rate tooth-staining (MacPherson Modification of the Lobene Stain Index), was conducted; and smoking status and motivation to quit smoking were assessed. The safety evaluation at each visit included an oral tissue assessment in addition to assessment for any adverse events.

Eligibility criteria: Inclusion Criteria:

* daily smokers for at least one year
* motivated to quit smoking
* normal chewing ability
* willing to refrain from a dental prophylaxis for the duration of the study
* total extrinsic facial tooth stain score \> or = to 28, according to the MacPherson Modification of the Lobene Stain Index

Exclusion Criteria:

* \< 20 natural teeth
* inadequate oral hygiene

Primary outcomes:
measure: The primary objective of this study was to assess, by using the MacPherson modification of the Lobene Stain Index, the amount of extrinsic tooth-stain reduction from Baseline while quitting smoking using Nicorette Freshmint gum
timeFrame: 6 Weeks
Secondary outcomes:
measure: To assess reduction in tooth-staining in relation to usage of gums
timeFrame: 6 Weeks
measure: To assess smoking status
timeFrame: 6 Weeks
measure: To assess safety
timeFrame: 6 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: JJCPPW
name: Elisabeth A Kruse, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04314999: Frequency of Parasite Infestation in Patients With Chronic Spontaneous Urticaria
Official title: Häufigkeit Der Infestation Mit Parasiten Bei Patienten Mit Chronisch Spontaner Urtikaria, Eine Retrospektive Datenanalyse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Spontaneous Urticaria
Parasitic Disease
Keywords: Chronic Spontaneous Urticaria
Parasitic disease
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2020-03-19
Enrollment: 57
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a chric spontaneous urticaria who were being treated at the allergology of the university hospital Basel between the 1st of June and the 30th of September.

Brief summary: The goal of this study is to describe the prevalence and the type of parasite in patients with a chronic spontaneous urticaria as well as to describe the associations between parasitic disease and the characteristics of the patients, for example eosinophilia.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of a chronic spontaneous urticaria
* Age: 17 years old and up

Exclusion Criteria:

* No diagnosis of a chronic spontaneous urticaria
* Age: younger than 17 years

Primary outcomes:
measure: Number of patients with parasite infestation
timeFrame: Patients with a chronic spontaneous urticaria that were treated at the University hospital basel between the 1st of June 2019 and the 30th of September 2019
measure: Most common parasite subgroup
timeFrame: Patients with a chronic spontaneous urticaria that were treated at the University hospital basel between the 1st of June 2019 and the 30th of September 2019
Secondary outcomes:
measure: Correlation between migration Background/ travel history of the patients and parasite infestation
timeFrame: Patients with a chronic spontaneous urticaria that were treated at the University hospital basel between the 1st of June 2019 and the 30th of September 2019
measure: Correlation between gastrointestinal complaints of the patients and parasite infestation
timeFrame: Patients with a chronic spontaneous urticaria that were treated at the University hospital basel between the 1st of June 2019 and the 30th of September 2019
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: Allergology, University Hospital Basel
name: Esther Steveling-Klein, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03332199: A Psycho-educational Intervention for Symptom Cluster Management
Official title: A Psycho-educational Intervention for Symptom Cluster Management Among Cancer Patients Undergoing Chemotherapy in Vietnam
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Oncology
Keywords: symptom cluster
oncology
psychoeducation
symptom management
fatigue
pain
sleep disturbance
Lead sponsor: Hanoi Medical University
Sponsor class: OTHER
First posted: 2017-11-06
Enrollment: 102
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: The purpose of this study is to develop, implement and undertake a preliminary evaluation of a psychoeducational intervention for managing a cancer-related symptom cluster including pain, fatigue and sleep disturbance experienced by Vietnamese cancer patients.


Eligibility criteria: Inclusion Criteria:

* Are diagnosed with any type of cancer
* Are over 18 years of age
* Have finished the second chemotherapy cycle
* Expected prognosis of at least 12 months
* Karnofsky level of ≥ 60/100.
* Report three symptoms: fatigue, pain and sleep disturbance at severity level of equal or above 3 during the past 7 days.
* Ability to communicate in Vietnamese

Exclusion Criteria:

* Inability to complete questionnaires or participate in the intervention due to literacy level or communication impairment.
* Have been diagnosed with major psychiatric morbidity such as suicidal tendencies or schizophrenia.

Involved in other clinical trials

Primary outcomes:
measure: Symptom cluster
timeFrame: 4 weeks
measure: Fatigue
timeFrame: 4 weeks
measure: Pain
timeFrame: 4 weeks
measure: Sleep disturbance
timeFrame: 4 weeks
Secondary outcomes:
measure: Performance status
timeFrame: 4 weeks
measure: Depression and Anxiety
timeFrame: 4 weeks
measure: Health-related quality of life
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Hanoi Medical University
Study officials:
References:
citation: Nguyen LT, Alexander K, Yates P. Psychoeducational Intervention for Symptom Management of Fatigue, Pain, and Sleep Disturbance Cluster Among Cancer Patients: A Pilot Quasi-Experimental Study. J Pain Symptom Manage. 2018 Jun;55(6):1459-1472. doi: 10.1016/j.jpainsymman.2018.02.019. Epub 2018 Mar 2.