louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00715546: Autologous Adipose-Derived Stem Cell Transplantation in Patients With Lipodystrophy
Official title: Phase 1 Study of Autologous-Derived Stem Cell Transplantation in Patients With Lipodystrophy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Lipodystrophy
Keywords: Adipose-derived stem cell
Lipodystrophy
Lead sponsor: Irmandade Santa Casa de Misericórdia de Porto Alegre
Sponsor class: OTHER
First posted: 2008-07-15
Enrollment: 5
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the safety of the autologous transplantation of adipose-derived stem cells in the treatment of lipodystrophies.


Eligibility criteria: Inclusion Criteria:

* lipodystrophies with necessity of fat grafting
* accept to participate of the study

Exclusion Criteria:

* HIV infection
* Metastatic malignancy
* Body mass index \< 20 kg/m²
* Other severe systemic disease

Primary outcomes:
measure: Clinical evaluation of the transplanted area.
timeFrame: one year
Secondary outcomes:
measure: Presence of neovascularization, adipose transplantation reabsorption, tissue viability
timeFrame: one year
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Irmandade Santa Casa de Misericórdia
state: Rio Grande do Sul
Study officials:
affiliation: Irmandade Santa Casa de Misericórdia de Porto Alegre
name: Eduardo M. Chem, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01353846: Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients
Official title: Comparison Between Natural and Artificial Cycle in Recipient Oocyte Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Infertility
Keywords: oocyte donation program
natural cycle
hormone replacement therapy
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
First posted: 2011-05-16
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the natural cycle (without any medication) with the well-established artificial cycle in an egg donation program.

Detailed description: Oocyte donation is an assisted reproduction technique well established. In patients with ovarian function, it is necessary to synchronize the cycle of the egg donor with the recipient, usually through endometrial preparation of the recipient by artificial cycle, by administering a GnRH agonist on day 21 of cycle and then administered increasing doses of estrogen therapy to achieve adequate endometrial thickness.

The necessity of synchronization between donors and recipient, has made possible not routinely the natural cycle for oocyte donation.

The investigators have recently introduced oocyte vitrification and it allows us to plan the egg donation in a different way. Now the investigators can previously cryopreserved donor oocytes and at the time that the investigators have a compatible receiver, then, plan the donation In this study it will be possible compare the results of oocyte donation cycles in terms of pregnancy rate, implantation and liveborn, depending on whether the recipient has made an artificial cycle of preparation endometrial or a natural cycle.

Eligibility criteria: Inclusion Criteria:

* infertile females with preserved gonadal function
* ages 18 - 44 years old included
* first oocyte donation cycle

Exclusion Criteria:

* BMI: \> 28
* recurrent miscarriages (3 or more)
* recurrent of implantation failure
* severe male factor
* important miomas
* \> 44 years old
* Problems with the drugs used in the study

Primary outcomes:
measure: Preparation and treatment for Assisted Human Reproduction procedures and in the case opf pregnancy, follow up.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: IVI Valencia
Study officials:
affiliation: IVI Valencia
name: Dra. Pilar Alamá, MDPhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00224146: Transdermal (TDS) Oxybutynin (Oxytrol(r)) in Overactive Bladder
Official title: Multicenter Assessment of Transdermal Therapy in Overactive Bladder With Oxybutynin TDS (MATRIX)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Overactive Bladder
Urinary Incontinence
Quality of Life
Keywords: Oxytrol(r)
transdermal oxybutynin
overactive bladder
Lead sponsor: Watson Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-22
Enrollment: 2878
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: This study evaluates changes in health related quality of life outcomes in patients using Oxytrol(r)


Eligibility criteria: Inclusion Criteria:

* Adult patients with one or more symptom of overactive bladder, including urge urinary incontinence, urgency and/or frequency

Exclusion Criteria:

* Patients for whom Oxytrol(r) is contraindicated.
* Patients treated with Oxytrol(r) prior to participation in this study.
* Patients residing in long-term care facilities or nursing homes.

Primary outcomes:
measure: Change in health-related quality of life
Secondary outcomes:
measure: Change in other outcomes such as:
measure: depression
measure: work productivity
measure: participant satisfaction
measure: effect of enhanced patient education on any of the above outcomes
Other outcomes:
Locations:
city: Mobile
country: United States
state: Alabama
city: Tucson
country: United States
state: Arizona
city: Torrance
country: United States
state: California
city: Rocky Hill
country: United States
state: Connecticut
city: Valdosta
country: United States
state: Georgia
city: Gretna
country: United States
state: Louisiana
city: Bloomfield Hills
country: United States
state: Michigan
city: Poughkeepsie
country: United States
state: New York
city: Winston-Salem
country: United States
state: North Carolina
city: Tomball
country: United States
state: Texas
Study officials:
affiliation: Watson Laboratories, Inc.
name: Naomi V. Dahl, PharmD
role: STUDY_DIRECTOR
References:
citation: Sand P, Zinner N, Newman D, Lucente V, Dmochowski R, Kelleher C, Dahl NV. Oxybutynin transdermal system improves the quality of life in adults with overactive bladder: a multicentre, community-based, randomized study. BJU Int. 2007 Apr;99(4):836-44. doi: 10.1111/j.1464-410X.2006.06658.x. Epub 2006 Dec 20.
citation: Sand PK, Goldberg RP, Dmochowski RR, McIlwain M, Dahl NV. The impact of the overactive bladder syndrome on sexual function: a preliminary report from the Multicenter Assessment of Transdermal Therapy in Overactive Bladder with Oxybutynin trial. Am J Obstet Gynecol. 2006 Dec;195(6):1730-5. doi: 10.1016/j.ajog.2006.08.013.
citation: Staskin DR, Rosenberg MT, Dahl NV, Polishuk PV, Zinner NR. Effects of oxybutynin transdermal system on health-related quality of life and safety in men with overactive bladder and prostate conditions. Int J Clin Pract. 2008 Jan;62(1):27-38. doi: 10.1111/j.1742-1241.2007.01625.x. Epub 2007 Nov 15.
Clinical trial NCT06527846: Post Marketing Surveillance of JARDIANCE in Chronic Kidney Disease
Official title: Post Marketing Surveillance on Long Term Use of JARDIANCE® Tablets in Patients With Chronic Kidney Disease in Japan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Kidney Disease, Chronic
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2024-07-30
Enrollment: 1000
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: Patients with chronic kidney disease (CKD) who are prescribed JARDIANCE® Tablets for CKD according to the current Japanese package insert and never been treated with JARDIANCE® Tablets before enrolment.

Brief summary: Study objective is to investigate the safety and effectiveness of long-term daily use of JARDIANCE® Tablets in patients with chronic kidney disease under real-world use.


Eligibility criteria: Inclusion Criteria:

* Patients with CKD who are prescribed JARDIANCE® Tablets for CKD according to the current Japanese package insert and who provided written informed consent prior to enrolment in this study.
* Patients who have never been treated with JARDIANCE® Tablets (including treatment for Type 2 diabetes mellitus (T2DM) and/or chronic heart failure (CHF)) before enrolment.

Exclusion Criteria:

* None

Primary outcomes:
measure: Incidence of Adverse Drug Reactions (ADRs)
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Kidney disease progression
timeFrame: Up to 52 weeks
measure: Incidence of cardiovascular death
timeFrame: Up to 52 weeks
measure: Incidence of all cause death
timeFrame: Up to 52 weeks
measure: Incidence of hospitalization for heart failure
timeFrame: Up to 52 weeks
measure: Change from baseline in eGFR to the last observation on treatment
timeFrame: at baseline, at last observation on treatment (Up to 52 weeks)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Nippon Boehringer Ingelheim Co., Ltd.
Study officials:
References:
Clinical trial NCT00381446: Evaluation of Corneal Staining With Various Contact Lens/Solution Combinations
Official title: Evaluation of Corneal Staining With Market Contact Lens/Solution Combinations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Corneal Epithelial Disruption
Corneal Staining
Keywords: corneal staining
contact lens care
multipurpose solution
Lead sponsor: Andrasko, Gary, OD, LLC
Sponsor class: INDIV
Collaborators: name: Alcon Research
First posted: 2006-09-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to quantify the amount of corneal staining observed with various marketed contact lens/multipurpose solution combinations. The hypothesis is that there are measurable differences in the amount of corneal staining between the various combinations.

Detailed description: A series of clinical studies is being conducted at one research site using a double-masked, randomized cross-over design. Each study consists of asymptomatic daily wear soft contact lens wearers observed at baseline and at two and four hours post lens insertion. Corneal staining is being assessed using sodium fluorescein, a cobalt filter and a yellow filter. Subjective comfort assessments are obtained at each visit.

Eligibility criteria: Inclusion Criteria:

* currently wearing soft contact lenses daily wear for at least 2 weeks prior to study
* correct visual acuity of 20/30 or better each eye

Exclusion Criteria:

* history of hypersensitivity to any components of solution being tested
* any ocular condition prohibiting contact lens wear
* excessive baseline staining as defined in protocol
* use of topical or OTC ocular medications during the study
* seasonal allergies with significant effect on contact lens wear

Primary outcomes:
measure: Area of Corneal Staining
Secondary outcomes:
measure: Type (severity) of Corneal Staining
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Dr. Richard Erdey office
state: Ohio
Study officials:
name: Gary J. Andrasko, OD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02833246: Using a Patient-Centered mHealth Intervention to Improve Adherence to Oral Anticancer Medications
Official title: Using a Patient-Centered mHealth Intervention to Improve Adherence to Oral Anticancer Medications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcoma
Lung
Solid Tumor Gastrointestinal
Keywords: texting
Adherence to Oral Anticancer Medications
16-810
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is being done to determine if sending reminder text messages helps patients take their Oral Anticancer Medication (OAMs) when they are supposed to.


Eligibility criteria: Inclusion Criteria:

* Patient in the Sarcoma, Solid Tumor Gastrointestinal (ST GI), and Thoracic Medicine service at MSK.
* Starting a new treatment regimen that includes a single oral anticancer medication
* Patients must have a mobile phone that can send and receive SMS/MMS messages and is internet-enabled.
* Age 18 or older.
* Ability to speak and read English because we do not have the resources to translate the text messages into other languages.

Exclusion Criteria:

* Patient expresses inability or unfamiliarity with using SMS/MMS messaging on their phone and is unwilling to be trained in the use of this technology.

Primary outcomes:
measure: objective pill count
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Thomas Atkinson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01561846: Cheese Intake,CLA and Hypercholesterolemia
Official title: Randomized, Double Blind, Controlled, Cross Over Clinical Trial on Intake of CLA Enriched Cheese in Hypercholesterolemic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Modifications of LDL Cholesterol
Modifications of Enocannabinoid Levels
Keywords: Conjugated Linoleic Acid
LDL-cholesterol
Endocannabinoids
Lead sponsor: Azienda Ospedaliera Brotzu
Sponsor class: OTHER
Collaborators: name: University of Cagliari
First posted: 2012-03-23
Enrollment: 42
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: In this study the investigators aimed at verifying whether consumption of a sheep cheese, naturally enriched in ALA, CLA and VA, would modify the plasma lipid and endocannabinoid profiles in mild hypercholesterolemic subjects. This study was a 3-week, randomized, double blind, controlled, cross over clinical trial, conducted at the State Hospital Brotzu in Cagliari, Italy. The subjects were randomly assigned to eat 90g/d of the control or enriched cheese for 3 weeks, with a cross over after 3 weeks of washout.


Eligibility criteria: Inclusion Criteria:

* Adult volunteers with diagnosed mild hypercholesterolemia (total cholesterol 220-290 mg/dL)

Exclusion Criteria:

* Pregnant (or those planning to become pregnant during the study period) and lactating women
* Also individuals with a self-reported history of diabetes, inflammatory bowel disease, pancreatitis, gallbladder or biliary disease in the past 12 months, and lactose intolerance before the screening visit.
* Those with a history of cancer (except non-melanoma skin cancer) in the 2 years before screening, or of any major trauma or surgical event within 3 months before screening.
* Volunteers with the following characteristics were also excluded:

  * total cholesterol ≥300 mg/dL, serum triglycerides ≥250 mg/dL or ≤ 200 mg/dL, \*HDL ≥70mg/dL, BMI ≥ 30
  * uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg) at screening.
* Use of lipid-altering medications or supplements, and of anticoagulants, during the 2 weeks before screening and throughout the study was prohibited.
* Furthermore, we selected subjects with an Apo E aplotype 3/3, the most common in Sardinia, in order to avoid any variability in cholesterolemia due to a different dietary response.

Primary outcomes:
measure: decrease of LDL-cholesterol levels
timeFrame: 3 weeks
Secondary outcomes:
measure: endocannabinoid levels
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Cagliari
country: Italy
facility: Metabolic diseases Center AOBrotzu
Study officials:
affiliation: Department of biomedical sciences University of Cagliari, Italy
name: Sebastiano Banni, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT06487546: Repletion of Ergothioneine in Patients With Kidney Failure
Official title: Repletion of Ergothioneine in Patients With Kidney Failure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Esrd
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2024-07-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Dialysis removes potentially harmful chemicals from the blood but can also remove potentially valuable chemicals. One potentially valuable chemical called ergothioneine, which comes from our diet, is low in the blood of people receiving dialysis. For this research study, we hope to learn how well a daily ergothioneine supplement will replenish the levels in the blood of people with kidney failure.


Eligibility criteria: Inclusion Criteria:

* kidney failure receiving hemodialysis or peritoneal dialysis

Exclusion Criteria:

* blood transfusion within 90 days
* taking supplements which contain ergothioneine

Primary outcomes:
measure: erythrocyte levels of ergothioneine
timeFrame: weeks 1, 2, 4, 8, 12, and 16 (while taking ergothioneine); and weeks 20 and 24 (after stopping ergothioneine)
measure: plasma levels of ergothioneine
timeFrame: weeks 1, 2, 4, 8, 12, and 16 (while taking ergothioneine); and weeks 20 and 24 (after stopping ergothioneine)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Halliwell B, Tang RMY, Cheah IK. Diet-Derived Antioxidants: The Special Case of Ergothioneine. Annu Rev Food Sci Technol. 2023 Mar 27;14:323-345. doi: 10.1146/annurev-food-060822-122236. Epub 2023 Jan 9.
citation: Chen L, Zhang L, Ye X, Deng Z, Zhao C. Ergothioneine and its congeners: anti-ageing mechanisms and pharmacophore biosynthesis. Protein Cell. 2024 Feb 29;15(3):191-206. doi: 10.1093/procel/pwad048.
Clinical trial NCT06370546: Cardiac Response to Strength Training in Hypertensive Individuals
Official title: Evaluation of Cardiac Response to High and Low-Intensity Strength Training in Hypertensive Subjects
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Exercise
Hypertension
Lead sponsor: Universidad Católica del Maule
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 28
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial, single blinded.
Primary purpose: TREATMENT

Brief summary: This study aims to determine the acute effects of high and low-intensity strength training on cardiac autonomic control in hypertensive subjects

Detailed description: The present study aims to determine the cardiovascular response in hypertensive individuals between 30 and 60 years old to one session of high and low intensity strength training.

Participants will undergo a low-intensity strength training including squats, barbell rows, deadlifts and chest presses with a load dynamic of 12 repetitions for 6 sets at an execution speed of less than 55 % of your maximum weight. This is followed by a one-week washout period. Subsequently, high intensity strength training is performed with the same exercises but with a load of 6 repetitions for 6 series at an intensity greater than 80% of the maximum repetition speed. The order of the sessions will be random.

After each session, blood pressure will be recorded for 24 hours using a holter monitor, which will report pressures during both day and night

The results obtained will be determined by the differences in the before and after values. Consequently, the behavior of the following variables: 1) heart rate variability, 2) blood pressure and 3) heart rate will determine the final results of this research.

The entire study will be carried out at the Catholic University of Maule, in its Kinesiology laboratory.

Eligibility criteria: Inclusion Criteria:

* Participants exclusively diagnosed with hypertension by a medical professional

Exclusion Criteria:

* Participants with any other chronic medical condition
* Subjects with any upper or lower limb injury that prevents strength training
* Subjects with cardiovascular abnormalities other than hypertension

Primary outcomes:
measure: Heart rate variability
timeFrame: 2 hours
measure: Blood pressure systolic
timeFrame: 24 hours
measure: Blood pressure diastolic
timeFrame: 24 hours
measure: Blood pressure mean
timeFrame: 24 hours
measure: Heart Rate
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Talca
country: Chile
facility: Universidad Católica del Maule
state: Maule
Study officials:
References:
Clinical trial NCT03350646: Does the Volume of the Embryo Culture Medium During Embryo Transfer Affects the IVF Outcomes?
Official title: Low Versus High Volume of Culture Medium During Embryo Transfer: a Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical Pregnancy Rate
Keywords: embryo transfer
volume
culture medium
loading the catheter
clinical pregnancy rate
Lead sponsor: Aretaieion University Hospital
Sponsor class: OTHER
First posted: 2017-11-22
Enrollment: 236
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The aim of this study was to evaluate if higher volume (40-45μl VS 20-25 μl) of media used for embryo transfer affects the clinical outcomes in fresh IVF cycles.Patients who fulfilled the inclusion criteria and agreed to participate in the study, were randomized, on the day of the embryo transfer, into group A: low volume (20-25 μL) and group B: high volume (40-45 μL)

Detailed description: The volume of culture medium used for embryo transfer is a variable that has been speculated to affect the IVF outcome. It is known that ultra high volume (\>100 μl) of medium during embryo transfer may result in embryo expulsion out of the uterus or ectopic pregnancy. Similarly, some authors advocate that ultra low volume of transferring medium (\<10 μl) may negatively affect pregnancy and implantation rates.

However small differences in the volume of the culture medium may favor the outcome of the embryo transfer. The aim of this study was to evaluate if the use higher volume (40-45μl VS 20-25 μl) of media used for embryo transfer affects the clinical outcomes in fresh IVF cycles.

Eligibility criteria: Inclusion Criteria:

1. Age ≤ 45y.o.
2. BMI≤36 kg/m2,
3. Baseline FSH concentration \<15 IU/l,
4. Ovarian stimulation with the same GnRH antagonist protocol
5. Normal uterine cavity with endometrium thickness \>7mm and trilaminar morphology at the Time of transfer and semen
6. Parameters of \>1 million /ml motile spermatozoa with \>4% physiological morphology -

Exclusion Criteria:

1. PGD cycles
2. Frozen -thaw cycles
3. Natural cycles or patients following different ovarian stimulation protocol were excluded from the study

   -

Primary outcomes:
measure: Clinical pregnancy rate
timeFrame: 25 days after embryo transfer
Secondary outcomes:
measure: Implantation rate
timeFrame: 25 days after embryo transfer
measure: Ongoing pregnancy rate
timeFrame: 20 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Sigalos GAlpha, Michalopoulos Y, Kastoras AG, Triantafyllidou O, Vlahos NF. Low versus high volume of culture medium during embryo transfer: a randomized clinical trial. J Assist Reprod Genet. 2018 Apr;35(4):693-699. doi: 10.1007/s10815-017-1099-8. Epub 2017 Dec 12.