louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01944280: Investigating the Effectiveness of Intradialytic Massage on Cramping in Dialysis Patients
Official title: Investigating the Effectiveness of Intradialytic Massage on Cramping in Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
First posted: 2013-09-17
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Primary Aim. The primary aim is to determine the effectiveness of intradialytic massage on the frequency and severity of cramping among hemodialysis patients prone to lower extremity cramping during treatment.

Hypothesis: Compared to control patients, intervention patients will be significantly less likely to have intradialytic cramping that requires staff intervention or treatment termination.

This is a study involving 32 (16 intervention, 16 control) hemodialysis patients with frequent lower extremity cramps during treatment. Frequent cramping during dialysis treatments is defined as 1 or more episodes of lower extremity cramps during or after dialysis over the previous 2 weeks. Cramping frequency will be determined by chart notes. Muscle cramping is defined as contraction of the large muscle group of the lower extremities sufficiently painful to require intervention by the dialysis staff for relief.

The intervention group will receive a 20 minute massage of the lower extremities by a trained and licensed massage therapist during each treatment (3x per week) for 2 weeks. The control group will receive usual care by dialysis center staff.


Eligibility criteria: Inclusion Criteria:

* \>18 years of age and \<90 years of age.
* On hemodialysis greater than 6 months.
* A stable dry weight for the previous month.
* Frequent cramping during dialysis treatments defined as 1 or more episodes of lower extremity cramps during or after dialysis over the previous 2 weeks.
* Ability to give informed consent.

Exclusion Criteria:

* Sores or wounds on feet or lower legs.
* Dermatitis of lower legs or feet.
* Edema greater than 2+.
* Known history of Deep Vein Thrombosis.
* Vascular access (arteriovenous (A-V) graft, A-V fistula or catheter) for hemodialysis is located in the lower extremity.
* Evidence of open leg wounds, history of lower extremity amputation or documented history of peripheral vascular disease.
* Acute hemodynamic or clinical instability per the dialysis nurse or tech just prior to the intervention.

Primary outcomes:
measure: The primary aim is to determine the effectiveness of intradialytic massage on the frequency and severity of cramping among hemodialysis patients prone to lower extremity cramping during treatment.
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Centers For Dialysis Care
state: Ohio
Study officials:
affiliation: Case Western Reserve University
name: Ashwini Sehgal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01097980: Trazodone for SSRI-sexual Dsyfunction
Official title: The Efficacy of Trazodone for Selective Serotonin Reuptake Inhibitor-induced Sexual Dysfunction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sexual Dysfunction
Keywords: trazodone
SSRI
sexual dysfunction
5-HT2A polymorphism
Lead sponsor: Beitou Armed Forces Hospital, Taipei, Taiwan
Sponsor class: OTHER_GOV
First posted: 2010-04-02
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to investigate the efficacy of trazodone in the treatment of selective serotonin reuptake inhibitor(s) associated sexual dysfunction. The secondary domains assessed were the relationship between 5-HT2A polymorphism and treatment efficacy.


Eligibility criteria: Inclusion criteria were:

1. 20-65 years of age,
2. receiving SSRI treatment for more than four weeks,
3. minimal dose of fluoxetine, paroxetine, and citalopram are 20 mg/d, minimal dose of fluvoxamine and sertraline are 50 mg/d, and minimal dose of escitalopram is 10mg/d,
4. developing sexual dysfunction based on the definition of Arizona Sexual Experience-Chinese Version.

Exclusion criteria were:

1. receiving other antidepressant agents,
2. receiving antipsychotics,
3. having a currently unstable medical condition such as unstable angina or uncontrolled diabetes,
4. having any serious medical condition that affects sexual functioning such as epilepsy, serious head injury, brain tumor, HIV infection, Parkinson's disease, dementia, multiple sclerosis, or other neurological disorder,
5. being pregnant or planning to become pregnant during the study period,
6. experiencing psychotic symptoms,
7. being comorbidity with substance abuse, (8) developing sexual dysfunction before receiving SSRIs treatment.

Primary outcomes:
measure: The differences between trazodone and placebo in the Arizona Sexual Experiences Scale-Chinese Version scale at the end of week 6 were used as the primary study outcomes.
timeFrame: week 0 and week 6
Secondary outcomes:
measure: The association between 5-HT2A polymorphism and the changes in Arizona Sexual Experiences Scale-Chinese Version scale were evaluated.
timeFrame: week 6
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Psychiatry, Beitou Armed Forces Hospital
Study officials:
affiliation: Department of Psychiatry, Beitou Armed Forces Hospital, Taipei, Taiwan
name: Kuo-Tung Chiang, M.D.
role: STUDY_DIRECTOR
References:
citation: Stryjer R, Spivak B, Strous RD, Shiloh R, Harary E, Polak L, Birgen M, Kotler M, Weizman A. Trazodone for the treatment of sexual dysfunction induced by serotonin reuptake inhibitors: a preliminary open-label study. Clin Neuropharmacol. 2009 Mar-Apr;32(2):82-4. doi: 10.1097/WNF.0B013E31816D1CDC.
Clinical trial NCT03777280: Comparison Between Injection Molded PEEK Framework and Cobalt Chromium Framework in Removable Partial Denture Regarding Retention
Official title: Evaluation of Retention of Partial Denture Made of Injection Molded PEEK Framework Versus Cobalt Chromium Framework in Mandibular Kennedy Class I Edentulous Cases
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mandibular Prosthesis User
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-12-17
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is aiming to evaluate the retentive forces in PEEK framework RPD compared to Cobalt-Chrome framework RPD during attachment/detachment cycles in mandibular kennedy class I edentulous cases


Eligibility criteria: Inclusion Criteria:

* . kennedy class I edentulous subjects indicated for framework partial denture

Exclusion Criteria:

* Uncooperative patients and bad oral hygiene patients

Primary outcomes:
measure: Retention
timeFrame: change from baseline retention force after one month and after three months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Oral and Dental Medicine Cairo University
state: Manial
Study officials:
References:
citation: Souza JE, Silva NR, Coelho PG, Zavanelli AC, Ferracioli RC, Zavanelli RA. Retention strength of cobalt-chromium vs nickel-chromium titanium vs CP titanium in a cast framework association of removable partial overdenture. J Contemp Dent Pract. 2011 May 1;12(3):179-86. doi: 10.5005/jp-journals-10024-1031.
Clinical trial NCT05767580: Comparison of Dual Assignment, Cadence, and Gait Speed in Alzheimer's Dementia and Healthy Geriatric Individuals
Official title: Comparison of Dual Assignment, Cadence, and Gait Speed in Alzheimer's Dementia and Healthy Geriatric Individuals
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alzheimer Dementia
Keywords: dual task
cadance
gait speed
alzheimer demantia
Lead sponsor: Kırıkkale University
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: a total of 50 individuals, including 25 geraitric individuals with Alzheimer's dementia over the age of 65 and 25 healthy geraitric individuals

Brief summary: Tests will be performed in individuals with Alzheimer's dementia to compare dual-task and gait with healthy geriatric individuals.

Detailed description: In this study, it was aimed to compare double assignment, cadence and walking speed in Alzheimer's Dementia and Healthy Geriatric Individuals.

Individuals who can walk independently and who are diagnosed with Alzheimer's Dementia over the age of 65 and healthy individuals will be included in the study. It will be done with 50 people who voluntarily participated in the research.

As a data collection tool; The demographics formula with patient descriptive features is the Timed Get Up and Walk test to turn off double assignment, the 2 Minute Walk Test to evaluate the advertisement, and the Footprint Method to use cadence. It will be assessed with the Mini Mental State Test and the Montreal Cognitive Assessment Test to examine discriminative units.

Eligibility criteria: Inclusion Criteria:

* 65 years and older,
* Who volunteered to participate in the research,
* Able to walk independently,
* He was diagnosed with Alzheimer's by a physician for the experimental group,
* Having not been diagnosed with Alzheimer's for the control group
* Individuals who have not undergone surgery in the last 6 months
* Individuals who do not have cooperation and communication problems.

Exclusion Criteria:

* Under age 65
* Individuals who do not agree to participate in the research,
* Individuals who have a disability to do physical activity,
* Individuals who have undergone an operation in the last 6 months,
* Individuals with problems of cooperation and communication

Primary outcomes:
measure: Time Up Go
timeFrame: 6 month
Secondary outcomes:
measure: Dual tasking
timeFrame: 6 month
measure: Footprint method
timeFrame: 6 month
measure: Two-Minute Walk Test
timeFrame: 6 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00278980: Effect of C-Peptide on Diabetic Peripheral Neuropathy
Official title: Effect of C-Peptide on Diabetic Peripheral Neuropathy, a 6 Months Randomized Double-Blind, Placebo Controlled, Dose-Finding, Multicenter Study, With Parallel Groups
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 1
Diabetic Polyneuropathy
Lead sponsor: Creative Peptides Sweden Inc.
Sponsor class: INDUSTRY
First posted: 2006-01-19
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the effect of C-peptide administration on nerve function in patients with type 1 diabetes and peripheral sensory neuropathy.

Detailed description: It has been observed that C-peptide administration results in an activation of renal tubular and sciatic endoneural Na/K-ATPase of the rat and stimulation of endothelial nitric oxide synthase. The hypothesis is that C-peptide administration may improve peripheral nerve dysfunction in diabetic neuropathy by increasing nerve blood flow and Na/K-ATPase activity. The purpose of the trial is to investigate the effect of C-peptide administration on diabetic peripheral sensory neuropathy in patients with type 1 diabetes and diabetic neuropathy in the lower extremities.

Eligibility criteria: Inclusion Criteria:

* Subjects who have a duration of type 1 diabetes of more than 5 yrs
* Subjects who are C-peptide deficient
* Subjects who have diabetic distal symmetric neuropathy, according to the criteria defined at the San Antonio Conference on Diabetic Neuropathy 1988
* Subjects who have measurable action potential in the sural nerves
* Subjects who have reduced nerve conduction velocity in the sural nerves

Exclusion Criteria:

* Subjects who have neuropathy or signs of nerve dysfunction which may be a consequence of factors other than type 1 diabetes
* Subjects who have concomitant medication that may interfere with the peripheral nerve function or measurement thereof
* Subjects who are transplanted (islet cell, kidney or pancreas)

Primary outcomes:
measure: Change in sensory nerve conduction velocity from baseline to 6 mo of treatment
Secondary outcomes:
measure: - Change in quantitative sensory tests and
measure: neurological impairment assessment from baseline to 6 mo of treatment
measure: - Safety and tolerability of C-peptide
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Solna
Study officials:
affiliation: Karolinska University Hospital Solna, Stockholm, Sweden
name: Lisa Juntti-Berggren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06899880: Perfusion Parameters and Outcome During a Standardized Deresuscitation Strategy with Net Ultrafiltration: a Retrospective Cohort Study.
Official title: Perfusion Parameters and Outcome During a Standardized Deresuscitation Strategy with Net Ultrafiltration: a Retrospective Cohort Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fluid Overload
Acute Kidney Injury
Continuous Renal Replacement Therapy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adults' patients with fluid overload and continuous renal replacement therapy in intensive care unit

Brief summary: Hemodynamic tolerance of fluid removal during deresuscitation is a cornerstone of the impact on outcome of such a strategy. However, how to define and to predict hemodynamic tolerance to fluid removal remains controversial. The investigators routinely use a standardized deresuscitation protocol in patients with fluid overload and continuous renal replacement therapy combined with monitoring of clinical and biological perfusion parameters.

The aim of the study was to describe perfusion during deresuscitation, and to determine whether it is associated with major adverse kidney events at day 30.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Acute kidney injury requiring continuous renal replacement therapy
* Standardized deresuscitation following a routine care protocol

Exclusion Criteria:

* Chronic hemodialysis
* Advanced directives to withhold or withdraw life-sustaining treatment,
* Patient's opposition to the use of his/her personal health data

Primary outcomes:
measure: MAKE 30
timeFrame: A day 30 after the initiation of the deresuscitation strategy
Secondary outcomes:
Other outcomes:
Locations:
city: France
country: France
facility: Louis Pradel Hospital
state: Bron
Study officials:
References:
Clinical trial NCT01321580: Hemoglobin MASIMO (Pronto 7) and Laboratory Measurement
Official title: Comparison of the Hemoglobin Results Obtained With the Masimo Pronto 7 and the Clinical Laboratory Measurement Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emergencies
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2011-03-23
Enrollment: 300
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: The purpose of this study is to compare the hemoglobin results obtained with the Masimo Pronto 7 and the Clinical Laboratory.


Eligibility criteria: Inclusion Criteria:

* emergency unit patients requiring an hemoglobin determination

Exclusion Criteria:

* none

Primary outcomes:
measure: accuracy of Masimo Pronto 7
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
References:
citation: Gayat E, Aulagnier J, Matthieu E, Boisson M, Fischler M. Non-invasive measurement of hemoglobin: assessment of two different point-of-care technologies. PLoS One. 2012;7(1):e30065. doi: 10.1371/journal.pone.0030065. Epub 2012 Jan 6.
Clinical trial NCT00141180: CP-481,715 Nickel Allergy Study.
Official title: Placebo-Controlled, Randomized, Parallel Group, Multiple-Dose Study to Evaluate the Effects of CP-481,715 on Clinical Response and Cellular Infiltration Following Contact Allergen Challenge to the Skin of Nickel Allergic Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dermatitis, Allergic Contact
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the suitability of contact allergy as a method for the evaluation of c-chemokine receptor-1 antagonist.


Eligibility criteria: Inclusion Criteria:

* A history of nickel allergy confirmed by a visual positive reaction (graded at least ++) to T.R.U.E. TEST.

Exclusion Criteria:

* Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding contact allergic dermatitis or untreated, asymptomatic, seasonal allergies at time of dosing).

Primary outcomes:
measure: Effect of CP-481,715 on clinical response and cell infiltration after nickel challenge
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Austin
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Bryan
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Hellerup
country: Denmark
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03170180: Exploratory Study of Drug Sensitivity Prediction Software (IRCR-DReSS) With Patient-derived Tumor Cells of Metastatic Gastric Cancer
Official title: Exploratory Study of Drug Sensitivity Prediction Software (IRCR-DReSS) With Patient-derived Tumor Cells of Metastatic Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stomach Neoplasms
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 66
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 1. Metastatic gastric cancer patients who failed standard treatment will be enrolled in this study.
2. After consent form, patient-derived cancer cell will be collected and tested with 3 kinds of drugs (sunitinib, gefitinib, imatinib).
3. Drug sensitivity prediction software (IRCR-DReSS) will present level of sensitivity and patients will be treated with sensitive drugs.
4. Patients will be evaluated every 6 weeks.


Eligibility criteria: Inclusion Criteria:

* age\>-20
* metastatic gastric cancer
* life expectancy \>-3 months
* ascites and pleural effusion that can be drained
* ECOG 0-2
* Proper organ function
* Patients who will be enrolled in sunitinib, gefitinib, imatinib clinical trial

Exclusion Criteria:

* HBeAg, HCV, HIV (+)
* Active infection
* Uncontrolled systemic disease

Primary outcomes:
measure: response rate
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Jeeyun Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03332680: EmbryoGlue as an Embryo Transfer Medium
Official title: A Randomised Controlled Trial Assessing the Effectiveness of EmbryoGlue® as an Embryo Transfer Medium in IVF Treatment Cycles
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Oxford Fertility Limited, United Kingdom
First posted: 2017-11-06
Enrollment: 730
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a positive control study with a single site two arm parallel design
Primary purpose: TREATMENT

Brief summary: In Vitro Fertilisation (IVF) is an increasingly common treatment for infertility. Clinics which offer IVF are continuously trying to improve their success rates, measured by the numbers of IVF cycles which result in the birth of a live baby.

One factor which is thought to have contributed to the success of IVF is the improvements in the embryo culture media, that is, the fluid in which the embryo resides in the laboratory before being replaced into a woman's womb. This trial seeks to identify if IVF cycles in which a particular culture media called EmbryoGlue is used have better results when compared to IVF cycles in which a conventional embryo transfer media is used.


Eligibility criteria: Inclusion Criteria:

• Couples having embryo transfer for fertility treatment

Exclusion Criteria:

* Cycles in which elective freezing of all embryos is clinically indicated (e.g. severe risk of OHSS, biopsy patients)
* Use of donor gametes
* Having endometrial scratch technique this cycle
* Concurrent participation in clinical trial(s)
* Previously randomised to this study
* Planned self-fund of EmbryoGlue as transfer media

Primary outcomes:
measure: Live Birth Rate
timeFrame: outcome data up to 9 months after intervention
Secondary outcomes:
measure: Implantation rate
timeFrame: outcome data up to 9 months after intervention
measure: Clinical pregnancy rates,
timeFrame: outcome data up to 9 months after intervention
measure: Adverse IVF events.
timeFrame: outcome data up to 9 months after intervention
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Fertility
Study officials:
References: