louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02748655: Alkaline Ionized Water: Sports Recovery and Inflammation Management
Official title: Alkaline Ionized Water: Sports Recovery and Inflammation Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Sports Recovery
Lead sponsor: Natural Immune Systems Inc
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 12
Sex: MALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine whether consumption of alkaline ionized water is effective for accelerating sports recovery.

Detailed description: Alkaline ionized water versus tap water is consumed for one week prior to an exercise challenge, using a cross-over study design.

Eligibility criteria: Inclusion Criteria:

* Male
* Age 25-40 years (inclusive)
* Body mass index (BMI) between 19.0 and 29.9 kg/m2 (inclusive)
* Not regularly exercising or participating in team sports.

Exclusion Criteria:

* Bariatric surgery
* Diagnosed and medicated for diabetes
* Known serious chronic health condition
* Serious active illness within past 12 months
* Major surgery during past 8 weeks
* Alcohol consumption of more than four standard units/day (for example more than four regular 12-oz beers (5% alcohol), four small 5-oz glasses of wine (12% alcohol), or four 1.5 oz shots of 80-proof spirits) (or more than 28 per week);
* Regular use of marijuana products for the past three months
* Regular consumption of energy drinks
* Diagnosed with any blood clotting disorder or taking clotting factor concentrates.
* Taking any blood thinners or anticoagulants
* Taking anti-inflammatory medications on a daily basis (81 mg aspirin is acceptable)
* Diagnosed with high blood pressure or taking blood pressure medication
* Use of performance enhancing drugs within the last three months
* Having consumed prednisone (or related steroid medication) or received a prednisone injection within the last six months

Primary outcomes:
measure: Plasma lactate levels
timeFrame: One hour
Secondary outcomes:
measure: Complete Blood Count
timeFrame: One hour
Other outcomes:
Locations:
city: Klamath Falls
country: United States
facility: NIS Labs
state: Oregon
Study officials:
affiliation: Natural Immune Systems Inc
name: Gitte S Jensen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01823055: Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device
Official title: Safety and Efficacy of a Transvaginal Suture Capturing Mesh Device: The Nordic Uphold LITE Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Repair of Middle Compartment Prolapse (Vaginal Vault or Uterine Prolapse) With or Without Cystocele
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Stockholm County Council, Karolinska Institutet research foundations, Swedish Society of Medicine, Boston Scientific
First posted: 2013-04-04
Enrollment: 214
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To perform a clinical safety and efficacy assessment of the Uphold LITE system for pelvic organ prolapse in a prospective multicenter, single cohort study.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older and present with primary or recurrent prolapse of the middle vaginal compartment corresponding to stage 2 or higher (according to the Pelvic Organ Prolapse Quantification \[POP-Q\] system)9,
* with or without anterior vaginal wall prolapse, and
* experiences symptoms of vaginal bulging with or without a previous hysterectomy
* being able to provide oral and written informed consent before entering the study.

Exclusion Criteria:

* previous cancer of any pelvic organ,
* systemic glucocorticoid treatment,
* insulin-treated diabetes,
* an inability to participate in study follow-up or to provide informed consent, or
* the need for any concomitant pelvic surgery.

Primary outcomes:
measure: Immediate and delayed complications related to the surgical procedure
timeFrame: 1 year
Secondary outcomes:
measure: Pelvic Organ Prolapse Quantification system
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04907955: Visual Performance Following Implantation of Presbyopia Correcting IOLs
Official title: Visual Performance Following Implantation of 3 Presbyopia Correcting Intraocuar Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Loss of Visual Contrast Sensitivity
Near Vision
Visual Impairment
Lead sponsor: Dar Al Shifa Hospital
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the current study was to compare the visual performance after bilateral implantation of the Panoptix IOL , or the AT LISA IOL or Tecnis Symfony IOL . The focus was on intermediate vision, defocus curves, and contrast sensitivity.


Eligibility criteria: Inclusion Criteria:

* patients with normal ocular examination apart from cataract.

Exclusion Criteria:

* previous ocular surgery.
* ocular pathology or corneal abnormalities.
* an endothelial cell count below 2000 cells/mm2.
* corneal astigmatism greater than 1.0 diopter (D) measured with Scheimpflug tomography (Sirius, CSO, Italy).

Primary outcomes:
measure: visual acuity
timeFrame: 6 months postoperatively.
Secondary outcomes:
measure: defocus curve
timeFrame: 6 months postoperatively.
measure: contract senstivity
timeFrame: 6 months postoperatively.
measure: photic phenomena
timeFrame: 6 months postoperatively.
measure: spectacle independence
timeFrame: 6 months postoperatively.
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Daralshifa hospital
Study officials:
References:
Clinical trial NCT05317455: Regulation of Brain Glucose Metabolism in Type 1 Diabetes
Official title: Regulation of Brain Glucose Metabolism in Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Diabetes Mellitus, Type 1
Hypoglycemia Unawareness
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2022-04-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a prospective randomized placebo-controlled double-blind crossover pilot study determining the effect of dichloroacetate on brain function under clamped hypoglycemia in T1DM.

Detailed description: This study is a prospective randomized placebo-controlled double-blind crossover study designed to address the hypothesis that dichloroacetate has the ability to re-activate brain glucose metabolism under clamped hypoglycemia. The study population is comprised of intensively treated persons with T1D with frequent exposure to hypoglycemia, who have cognitive deficits under hypoglycemia that could be attributed to changes in brain glucose oxidation. The investigators will test the experimental compound DCA in a study that determines whether restoring brain glucose metabolism under hypoglycemia helps maintain cognitive function.

Eligibility criteria: Inclusion Criteria:

T1DM subjects with:

* a history of severe hypoglycemia and/or hypoglycemia unawareness or
* a history of severe hypoglycemia with a blood glucose \<54 mg/dL, requiring the assistance of another person (with recovery after the administration of oral carbohydrate, intravenous glucose, or glucagon) or
* at least 2 values \<54mg/dl during 2 weeks of CGMS testing during the week prior to study.

Exclusion Criteria:

* Age \< 18 years or \>55 years.
* Body weight \>85 kg at screening visit
* BMI \> 30 (female) and \>30 (male) kg/m2.
* Untreated proliferative retinopathy
* carriers of glutathione transferase Z1 (GSTZ-1) gene polymorphisms that predispose to DCA accumulation and toxicity

Primary outcomes:
measure: Cognitive Function
timeFrame: 1 day
Secondary outcomes:
measure: Brain glucose metabolism
timeFrame: 1 day
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
Study officials:
affiliation: Yale University
name: Raimund Herzog, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03578055: BDD With UDCA Therapy After Laparoscopic Cholecystectomy
Official title: Prospective Study for the Effects of Biphenyl Dimethyl Dicarboxylate and Ursodeoxycolic Acid Therapy on Liver Function and Quality of Life After Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cholecystitis, Acute
Cholecystitis, Chronic
Lead sponsor: Ewha Womans University Mokdong Hospital
Sponsor class: OTHER
First posted: 2018-07-05
Enrollment: 172
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: Prospective Study for the Effects of Biphenyl Dimethyl Dicarboxylate and Ursodeoxycolic Acid Therapy on Liver Function and Quality of Life After Laparoscopic Cholecystectomy

Primary endpoint: peak level of postoperative AST (aspartate transaminase) and postoperative ALT (alanine tansaminase)

Secondary endpoint: postoperative GIQLI (Gastrointestinal Quality of Life index) score

Detailed description: Because the gallbladder is adjacent to the liver, liver enzymes are often elevated when cholecystitis occurs. BDD and UDCA drugs are known to be effective in preserving liver function. The use of BDD and UDCA drugs in patients with cholecystitis is expected to inhibit elevated liver enzyme levels and to maintain liver function. The aim of this study is to analyze the effects of BDD and UDCA medication on postoperative changes in hepatic enzyme levels and quality of life in patients LFT elevated cholecystitis.

Eligibility criteria: Inclusion Criteria:

* Patients scheduled for surgery due to chronic cholecystitis and acute cholecystitis

Exclusion Criteria:

* Failure to obtain consent
* Under 19 years
* If you have intellectual ability to understand this study
* When performing cholecystectomy with other operations
* Total bilirubin levels\> 2 mg / dl
* If you are enrolled in another clinical trial

Primary outcomes:
measure: Serum Aspartate Aminotransferase
timeFrame: Postoperative 30 days
measure: Serum Alanine Aminotransferase
timeFrame: Postoperative 30 days
Secondary outcomes:
measure: GIQLI (Gastrointestinal Quality of Life Index)
timeFrame: Postoperative 30 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
Study officials:
affiliation: Ewha Womans University Mokdong Hospital
name: Huisong Lee, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00448955: Open-Label Study of ARD-0403 in Testosterone Deficient Men
Official title: A Phase III Open-Label Study of the Efficacy and Safety of ARD-0403, a Testosterone Cream, in Testosterone Deficient Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypogonadism
Lead sponsor: Ardana Bioscience Ltd
Sponsor class: INDUSTRY
First posted: 2007-03-19
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Male hypogonadism, a disorder associated with testosterone deficiency, is frequently seen in clinical practice and has significant effects on patient wellbeing. The purpose of this study is to investigate the efficacy and safety of ARD-0403 as a testosterone replacement therapy in testosterone deficient men.


Eligibility criteria: Inclusion Criteria:

* Testosterone deficiency

Exclusion Criteria:

* Previous treatment with testosterone replacement therapy within 4 weeks
* Moderate-severe benign prostatic hypertrophy, or prostatic cancer
* Haematocrit \>50%

Primary outcomes:
measure: Pharmacokinetic
Secondary outcomes:
measure: Safety and tolerability
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Medical Affiliated Research Center, Inc
state: Alabama
city: Stanford
country: United States
facility: Stanford University
state: California
city: Torrance
country: United States
facility: Los Angeles Biomedical Research Institute at Harbor-UCLA
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Houston
country: United States
facility: Michael E. Debakey VAMC
state: Texas
city: San Antonio
country: United States
facility: dgd Research
state: Texas
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
Study officials:
References:
Clinical trial NCT00090155: 2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-090)(COMPLETED)
Official title: A Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of 2 Doses of Aprepitant for the Prevention of Postoperative Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2004-08-27
Enrollment: 805
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the safety and efficacy of 2 doses of an approved drug for a new indication in the prevention of postoperative nausea and vomiting in patients receiving general anesthesia for open abdominal surgery requiring overnight hospital stay.

Detailed description: The duration of treatment is 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Patient is at least 18 years of age.
* Patient is scheduled to undergo open abdominal surgery requiring overnight hospital stay (24-hour hospital stay after end of surgery).
* Patient is scheduled to receive general anesthesia.
* Patient is scheduled to receive postoperative medication.

Primary outcomes:
measure: Prevention of PONV in the 24 hours following end of surgery; Tolerability
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Gan TJ, Apfel CC, Kovac A, Philip BK, Singla N, Minkowitz H, Habib AS, Knighton J, Carides AD, Zhang H, Horgan KJ, Evans JK, Lawson FC; Aprepitant-PONV Study Group. A randomized, double-blind comparison of the NK1 antagonist, aprepitant, versus ondansetron for the prevention of postoperative nausea and vomiting. Anesth Analg. 2007 May;104(5):1082-9, tables of contents. doi: 10.1213/01.ane.0000263277.35140.a3.
citation: Diemunsch P, Apfel C, Gan TJ, Candiotti K, Philip BK, Chelly J, Carides AD, Evans JK, Ho TW, Reiss T. Preventing postoperative nausea and vomiting: post hoc analysis of pooled data from two randomized active-controlled trials of aprepitant. Curr Med Res Opin. 2007 Oct;23(10):2559-65. doi: 10.1185/030079907X233115.
Clinical trial NCT04654455: Prospective Study Evaluating Dry Eye in Patients Operated on for Ametropia by LASIK Surgery and Treated With REPADROP
Official title: Prospective Study Evaluating Dry Eye in Patients Operated on for Ametropia by LASIK Surgery and Treated With REPADROP
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ametropia
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-12-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient admitted to hospital for LASIK surgery for ametropia

Brief summary: LASIK is a refractive surgery technique widely used in France. Postoperatively, the classic treatment after LASIK consists of instilling drops to reduce dry eyes. REPADROP® is an innovative eye drops stimulating corneal innervation. To date no study has quantified the improvement in dry eye syndrome and thus the quality of life of patients using REPADROP®.


Eligibility criteria: Inclusion Criteria:

Age over 18

* Planned bilateral LASIK surgery
* Use of Repadrop as postoperative eye drops
* Patient agreement to participate

Exclusion Criteria:

* History of corneal pathology
* Diabetes
* History of treatment with REPADROP® or CACICOL® or NGF® (other eye drops which are no longer available on the market to date but which would also improve corneal healing)
* Ongoing treatment with topical cyclosporine
* Presence of punctal plugs
* Adults who are the subject of a legal protection measure (guardianship, curators)
* Pregnant or breastfeeding women

Primary outcomes:
measure: Variation in OSDI (Ocular Surface Disease Index) score
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Edouard Herriot
state: Rhone
Study officials:
References:
Clinical trial NCT03177655: Effect of Guided Imagery on Well-being in Patients With Multiple Sclerosis
Official title: Effect of Guided Imagery on Well-being in Patients With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis (MS)
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2017-06-06
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This single-center interventional study quasi-randomly allocated patients to a guided imagery or control intervention (positive journaling). Data were analyzed with treatment allocation masked.

Detailed description: Interventions: Participants were assigned in alternate order to 10 weekly 1-hour sessions "Healing Light Guided Imagery" or at-home positive journaling; drop-outs were replaced.

Intervention Type: Behavioral

Multiple sclerosis (MS) is an autoimmune disease that affects the brain and spinal cord (central nervous system). Because nerves in any part of the brain or spinal cord may be damaged, patients with multiple sclerosis can have symptoms in different parts of the body. Many Multiple Sclerosis patients suffer from depression, fatigue and anxiety in addition to physical symptoms. Drugs prescribed for MS have been shown to not improve these comorbid psychological symptoms. Researchers have shown that mindfulness-based training programs can help MS patients, but these therapies are highly resource demanding and taxing for those involved. "Healing Light" Guided Imagery (HLGI; supplementary materials) is a guided imagery therapy that simulates a self-hypnotic trance state that has been anecdotally shown to improve depression and fatigue in patients with MS in less time and with fewer support resources. The investigators plan to test whether HLGI can increase patient well-being.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of Relapsing-Remitting Multiple Sclerosis
2. 18-70 years old
3. Able to read and write in English
4. Able to attend sessions at the UC San Diego School of Medicine

   * Age group: adult
   * Gender: both
   * Target enrollment: 20

Participant exclusion criteria:

1. Severe depression (score of 31 or higher on the BDI)
2. Very high levels of fatigue (above an average of 6 on the FSS)
3. Low levels of mindfulness (below an average score of 2 on the FMI).

Primary outcomes:
measure: Quality of Life (MS-QOL-54)
timeFrame: Change from baseline at 10 weeks
Secondary outcomes:
measure: Mood (BDI-II)
timeFrame: Change from baseline at 10 weeks
measure: Fatigue (FSS)
timeFrame: Change from baseline at 10 weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego
state: California
Study officials:
References:
Clinical trial NCT00549055: A Study On The Efficacy Of Macugen Injections In Patients With Neovascular Age-Related Macular Degeneration In Real Life.
Official title: A Study On The Efficacy Of Macugen Injections In Patients With Neovascular Age-Related Macular Degeneration (AMD) In Real Life (Macureli Study).
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neovascular Age-related Macular Degeneration
Keywords: Macugen Age-related macular degeneration (AMD) Observational study
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-10-25
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who obtained reimbursement for Macugen, recruited by retina specialists from ophthalmology centres with experience in intravitreal injections.

Brief summary: To assess effectiveness of Macugen for treatment of neovascular age-related macular degeneration by measuring the evolution of visual acuity. Treatment duration, frequency of administration and combination with other treatments will also be evaluated.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with subfoveal neovascular (wet) age-related macular degeneration
* Patients having received at least 1 Macugen injection
* Treatment naive patients, or patients having received conventional therapy
* Patients having signed and dated informed consent.

Exclusion Criteria:

* Patients participating in another clinical study with Macugen.

Primary outcomes:
measure: Change From Baseline to Final Visit in Visual Acuity (VA) Score
timeFrame: Baseline, Month 24 or Early Termination
Secondary outcomes:
measure: Number of Participants With Change in VA: Improvement
timeFrame: Months 3, 6, 9 and 12
measure: Number of Participants With Change in VA: Stabilization
timeFrame: Months 3, 6, 9 and 12
measure: Number of Participants With Change in VA: Worsening
timeFrame: Months 3, 6, 9 and 12
measure: Duration of Treatment
timeFrame: Baseline up to 28.4 months
measure: Frequency of Macugen Administration
timeFrame: Baseline up to 28.4 months
measure: Number of Participants Who Received Other Concomitant Age Related Macular Degeneration (AMD) Treatments
timeFrame: Months 3, 6, 9 and 12
Other outcomes:
Locations:
city: Aarschot
country: Belgium
facility: Pfizer Investigational Site
city: Deurne
country: Belgium
facility: Pfizer Investigational Site
city: Leuven
country: Belgium
facility: Pfizer Investigational Site
city: Liege
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: