louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02124395: Health-related Quality of Life in Rare Kidney Stone
Official title: Assessment of Health-related Quality of Life in Rare Kidney Stone Formers in the Rare Kidney Stone Consortium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Hyperoxaluria
Cystinuria
Adenine Phosphoribosyl Transferase Deficiency
Dent Disease
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2014-04-28
Enrollment: 365
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sample will be selected from the Rare Kidney Stone Consortium registries

Brief summary: Assessment of Health-related Quality of Life in Rare Kidney Stone Formers in the Rare Kidney Stone Consortium

Detailed description: The purpose of this study is to learn about Health-related Quality Of Life (HRQoL) in patients enrolled in the Rare Kidney Stone Consortium (RKSC) registries. Quality of life studies look at different aspects of both physical and mental components of people's lives. HRQoL data for people affected by kidney stones are not currently available for people followed over time.

Eligibility criteria: Inclusion Criteria:

* Qualify to participate in one of the Rare Kidney Stone Registries.
* Be at least 5 years old (for SF-10)
* Are able to communicate using the English language
* Consent to participate in the study (or "assent" if under 18 years old)
* Have internet access with an email account or a valid home address

Exclusion Criteria:

None, if inclusion criteria are met

Primary outcomes:
measure: Assessment of HRQoL in patients with rare kidney stones
timeFrame: Once a year for up to 5 years after signed consent
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Primary Hyperoxaluria and Dent Disease Registry - Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: New York University School of Medicine - Cystinuria Registry
state: New York
city: Reykjavik
country: Iceland
facility: APRT Registry - Landspitali Universtiy Hospital
Study officials:
affiliation: NYU Langone Health
name: David Goldfarb, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Modersitzki F, Pizzi L, Grasso M, Goldfarb DS. Health-related quality of life (HRQoL) in cystine compared with non-cystine stone formers. Urolithiasis. 2014 Feb;42(1):53-60. doi: 10.1007/s00240-013-0621-4. Epub 2013 Nov 20.
Clinical trial NCT00750295: A Clinical Study to Evaluate the Safety, Tolerability and Activity of a New Phosphate Binder (SBR759) in Patients With Chronic Kidney Disease on Hemodialysis
Official title: An Open Label, Multiple Dose, Time-lagged, Switch Study to Evaluate the Safety, Tolerability and Activity of Escalating SBR759 Doses in Patients With Chronic Kidney Disease on Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Chronic Kidney Disease
Keywords: Chronic kidney disease,
hemodialysis,
serum phosphorus,
phosphate binders
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-09-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to assess the safety, tolerability and activity of escalating multiple doses of SBR759 in patients with chronic kidney disease on hemodialysis.


Eligibility criteria: Inclusion Criteria:

* Patients must be treated with maintenance hemodialysis and prescribed a phosphate binder.
* A controlled serum phosphorus.
* Constant dose of concomitant medications.
* Women of child bearing potential must be practicing an acceptable form of birth control (i.e. double barrier method - intrauterine device plus condom, spermicidal gel plus condom). All female patients must have a negative pregnancy test at screening in order to be eligible to participate in the study.

Exclusion Criteria:

* Patient has been hospitalized within 30 days prior to screening or has a surgery scheduled during the study.
* Patient has an unstable medical condition, an active infection, active malignancy (except for basal cell carcinoma of the skin), a history of major GI tract surgery, or a history of hemochromatosis.
* Patient is receiving or has received an investigational drug (or is currently using an investigational device) within 30 days prior to screening.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: In addition to the standard safety assessments (vital signs, ECGs, clinical chemistry and adverse events), serum phosphorus concentration is frequently measured during the study.
Secondary outcomes:
measure: Several biomarkers and patient-reported outcomes are assessed at specified time points, before and after treating patients with the study drug.
Other outcomes:
Locations:
city: Denver
country: United States
facility: Novartis Investigator Site
state: Colorado
Study officials:
affiliation: Novartis Investigator Site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00485095: The Effect of Plant Sterol Supplement on Blood Cholesterol
Official title: A Single Centre, Randomized Crossover Double-Blind Placebo-Controlled Study to Measure the Effect of Plant Sterol Supplement on Blood Cholesterol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: High Blood Cholesterol Level
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Mills DA
First posted: 2007-06-12
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether supplement of plant sterol could lower blood cholesterol.


Eligibility criteria: Inclusion Criteria:

* Men and women 18-80 years old
* Total cholesterol: 4.5-7.5 mmol/l
* Triglycerides at or below 4.0 mmol/l

Exclusion Criteria:

* BMI at or above 35 kg/m2
* Secondary hyperlipidemia, included diabetes
* Hypertension (at og higher than 170/110)
* Coronar, perifery or cerebral vascular disease last 3 months
* Familial hypercholesterolemia
* Change in dose of statins, oestrogen or contraceptives last 3 months
* Taking drugs which are known to interfere with the plasma level of cholesterol
* Chronic rheumatoid diseases or other diseases known to affect c-reactive protein
* Pregnancy
* Lactation
* Planning to reduce weight
* Taking plant sterols

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Lipidklinikken, Rikshospitalet Radiumhospitalet HF
city: Oslo
country: Norway
facility: Rikshospitalet Radiumhospitalet HF, Oslo, Norway
Study officials:
affiliation: Lipidklinikken, Rikshospitalet-Radiumhospitalet HF
name: Leiv Ose, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ottestad I, Ose L, Wennersberg MH, Granlund L, Kirkhus B, Retterstol K. Phytosterol capsules and serum cholesterol in hypercholesterolemia: a randomized controlled trial. Atherosclerosis. 2013 Jun;228(2):421-5. doi: 10.1016/j.atherosclerosis.2013.03.001. Epub 2013 Mar 20.
Clinical trial NCT05243095: Computer-Assisted, Game-Based Cognitive Training on Attention
Official title: The Effect of Computer-Assisted, Game-Based Cognitive Training on Attention: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Young Adults
Attention
Keywords: Cognitive-training
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2022-02-16
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to investigate the effect of 8 weeks of cognitive training on attention function in healthy young people.


Eligibility criteria: Inclusion Criteria:

* Those between the ages of 21-24,
* No communication problem,
* Not continuing any exercise program for the last 1 year,
* Having a smart phone, tablet or computer required to participate in the training program,
* Individuals who volunteered to participate in the study.

Exclusion Criteria:

* Having vision and hearing problems,
* Individuals who continued the physical exercise program and/or had hobbies such as puzzles and jigsaw puzzles that could affect the cognitive level.

Primary outcomes:
measure: Stroop test
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Denizli
country: Turkey
facility: Pamukkale University
Study officials:
References:
Clinical trial NCT06241495: Aromatherapy in Providing a Semen Sample
Official title: The Effect of Aromatherapy on Anxiety, Difficulty in Providing a Semen Sample and Semen Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Male
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2024-02-05
Enrollment: 102
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate the effect of aromatherapy on the anxiety and difficulty of providing a semen sample and on semen volume, sperm concentration and motility percentage.

The study will be carried out in two different groups. After the men are evaluated in terms of eligibility criteria for the research, the men who are eligible will be informed about the research and written informed consent will be obtained from the men who accept. The random distribution of men to the study groups will be carried out random. The following applications will be made to the groups. Aromatherapy/placebo will be applied to the individuals included in the study. During the semen sample giving process, lavender oil/coconut oil (placebo) will be applied with a diffuser.


Eligibility criteria: Inclusion Criteria:

* Having applied to the center where the research will be conducted with a complaint of infertility
* Being 18 years or older

Exclusion Criteria:

* Individuals giving up on participating in the study
* Participant not being able to provide a semen sample
* Being diagnosed with azoospermia-oligozoospermia

Primary outcomes:
measure: Change in anxiety
timeFrame: before providing a semen sample, immediately after providing a semen sample
measure: Anxiety about providing a semen sample
timeFrame: immediately after providing a semen sample
measure: Difficulty providing a semen sample
timeFrame: immediately after providing a semen sample
Secondary outcomes:
measure: Semen volume
timeFrame: immediately after providing a semen sample
measure: sperm concentration
timeFrame: immediately after providing a semen sample
measure: sperm motility percentage
timeFrame: immediately after providing a semen sample
measure: Total sperm count
timeFrame: immediately after providing a semen sample
measure: Satisfaction with the oil used
timeFrame: immediately after providing a semen sample
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Fertility Diagnosis, Treatment, Research and Application Center
Study officials:
References:
Clinical trial NCT00737295: Ultrasound for Diagnosis of Biliary Dyskinesia
Official title: Study to Investigate the Role of Ultrasound for Diagnosis of Biliary Dyskinesia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Biliary Dyskinesia
Keywords: Biliary
Dyskinesia
Gallbladder
Cholecystitis
Lead sponsor: Texas Tech University Health Sciences Center
Sponsor class: OTHER
First posted: 2008-08-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective, non-randomized study of 50 people with suspected biliary dyskinesia. The purpose of this study is to investigate if it is possible to use ultrasound to make a diagnosis of a condition called biliary dyskinesia. The investigators null hypothesis is that there will be no statistical difference between the proposed experimental test (Ultrasound) and the HIDA scan (a nuclear medicine hepatobiliary system scan) in the diagnosis of biliary dyskinesia.


Eligibility criteria: Inclusion Criteria:

1. All subjects will have a suspected clinical diagnosis of biliary dyskinesia, including an ultrasound that demonstrates biliary wall thickness of \< 3 mm, and no gallstones present.
2. Written informed consent document.
3. Males and Females age \> 18 years

Exclusion Criteria:

1. Subjects without a suspected clinical diagnosis of biliary dyskinesia, including an ultrasound that demonstrates biliary wall thickness of \> 3 mm, and/or gallstones present.
2. Pregnant or breastfeeding women
3. Subjects who do not consent to take part in the study.

Primary outcomes:
measure: Does ultrasound test detect contraction of gallbladder following injection of a hormone cholecystokinin (CCK), and is the degree contraction as accurate as the accepted clinical standard (the HIDA scan) for diagnosis of biliary dyskinesia.
timeFrame: After HIDA scan performed
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University Health Sciences Center
state: Texas
Study officials:
affiliation: Texas Tech University Health Sciences Center
name: Thomas Warren, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00171795: Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury and Cognitive Impairment
Official title: Efficacy and Safety of Rivastigmine in Patients With Traumatic Brain Injury and Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Traumatic Brain Injury
Keywords: Traumatic brain injury,
cognitive impairment,
rivastigmine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is designed to investigate the efficacy and safety of rivastigmine compared with placebo in patients with traumatic brain injury and cognitive impairment.


Eligibility criteria: Inclusion Criteria:

* Traumatic brain injury confirmed by available brain imaging (CT or MRI) and be at least 52 weeks post injury
* Neuropsychologic disturbances indicated by: impaired memory (reduction of below 1 standard deviation (SD) of the mean on the California Verbal Learning Test (CVLT) and impaired executive function (reduction of below 1 standard deviation (SD) of the mean on the Verbal Memory Learning Test (VLMT) and Tower of London Test (ToL) and impaired attention (reduction of below 1 standard deviation (SD) of the mean on the Test Battery for Attentional Performance (TAP)
* Be required to have had sufficient education to read, write, and effectively communicate
* Be cooperative, able to ingest oral medication, and able to complete all aspects of the study and capable of doing so, either alone or with the aid of a responsible caregiver according to the investigator's judgement

Exclusion Criteria:

* A current diagnosis of cerebrovascular disease, any primary neurodegenerative disorder, or any other causes of neuropsychologic disturbances
* A current diagnosis of active, uncontrolled seizure disorder or major depression, or any other diagnosis that may interfere with the patient's response to study medication
* An advanced, severe or unstable disease of any type that may interfere with efficacy evaluations
* Female patients with child-bearing potential who are breast-feeding, pregnant or not practicing non-hormonal contraception

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: 20 week's treatment with rivastigmine on selective attention compared with placebo in patients with TBI and cognitive impairment
Secondary outcomes:
measure: Safety of rivastigmine
measure: Change from baseline to week 20 in cognitive functioning including selective attention, memory, executive function, and global clinical rating
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharma
role: STUDY_DIRECTOR
References:
Clinical trial NCT01278095: Oral Bioavailability of GLPG0555 in Different Solid Formulations
Official title: A Randomized, Open Label, 3-way Crossover Study to Compare the Oral Bioavailability of GLPG0555 After Single-dose Intake in Healthy Subjects as a Solid Dispersion Formulation, With and Without Food, Relative to a Nanosuspension Formulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Tolerability
Pharmacokinetics
Lead sponsor: Galapagos NV
Sponsor class: INDUSTRY
First posted: 2011-01-17
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the study is to compare the pharmacokinetics of a solid capsule formulation of GLPG0555 with a nanosuspension, and to assess safety and tolerability of a single dose of GLPG0555.


Eligibility criteria: Inclusion Criteria:

* healthy male
* BMI between 18-30 kg/m², inclusive.

Exclusion Criteria:

* significantly abnormal platelet function or coagulopathy
* smoking
* drug or alcohol abuse

Primary outcomes:
measure: Bioavailability of solid formulation
timeFrame: 72 hrs
Secondary outcomes:
measure: Safety and tolerability of single doses of GLPG0555
timeFrame: up to 10 days postdose
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: SGS Stuivenberg
Study officials:
affiliation: Galapagos NV
name: Gerben van 't Klooster, PhD
role: STUDY_DIRECTOR
affiliation: SGS Stuivenberg
name: Jos Leempoels, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06316895: The Clinical Outcomes and Prediction of Thermal Ablation for Low-risk Papillary Thyroid Carcinoma
Official title: The Clinical Outcomes and Artificial Intelligence Prediction Model of Ultrasound-guided Thermal Ablation for the Treatment of Low-risk Papillary Thyroid Carcinoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Papillary Thyroid Cancer
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 3772
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with low-risk papillary thyroid carcinoma who choose surgery or thermal ablation

Brief summary: 1. To evaluate the clinical outcomes of ultrasound-guided thermal ablation and thyroid surgery for the treatment of papillary thyroid carcinoma;
2. To develop and validate a artificial intelligence model to predict the outcomes of ultrasound-guided thermal ablation in the treatment of papillary thyroid carcinoma;


Eligibility criteria: Inclusion Criteria:

1. patients age between 18 and 80 year old, both sex
2. papillary thyroid carcinoma confirmed by core-needle biopsy or fine-needle aspiration
3. the largest diameter ≤2.0 cm
4. no clinical or imaging evidences of extrathyroidal extension, lymph node metastasis and distant metastasis on ultrasound, nech and chest CT
5. follow-up period ≥12 months,

Exclusion Criteria:

1. patients with convincing evidence of aggressive papillary thyroid carcinoma or other type of thyroid cancer by biopsy
2. history of neck radiation
3. history of thyroid surgery
4. coagulation disorder
5. serious heart, respiratory, liver, or renal failure
6. dysfunction of the vocal cord on the opposite side

Primary outcomes:
measure: rate of disease progression
timeFrame: more than 5 year
Secondary outcomes:
measure: Rate of complications
timeFrame: 1week
measure: Rate of tumor disappearance
timeFrame: 2 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
affiliation: Chinese PLA General Hospital
name: Yukun Luo
role: STUDY_CHAIR
References:
Clinical trial NCT00436995: Extension From Weekly to Once Every Other Week Darbepoetin Alfa Administration in Subjects With Chronic Kidney Disease Receiving Dialysis
Official title: A Multicentre, Single Arm Study Evaluating The Extension From Weekly To Once Every Other Week Darbepoetin Alfa Administration In Subjects With Chronic Kidney Disease Receiving Dialysis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Kidney Disease
Keywords: Dialysis
Anaemia
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2007-02-19
Enrollment: 114
Sex: ALL
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: The purpose of this study is to assess the proportion of subjects sucessfully achieving a mean Hemoglobin greater than or equal to 11 g/dL during the evaluation period following extension from Weekly (QW) to Once Every Other Week (Q2W) Darbepoetin Alfa administraion.


Eligibility criteria: Inclusion Criteria:

* Receiving dialysis for 3 months or more before enrollment.
* The mean of 2 screening Hb values taken at least 7 days appart must be greater than or equal to 11g/dL and less than or equal to 13.0 g/dL
* Receiving stable QW darbepoetin alfa doses for at least 6 weeks before enrollment
* Adequate iron stores (serum ferritin equal to or greater than 100 ug/L

Exclusion Criteria:

* Uncontrolled hypertension
* Prior history of Cardiovascular Incidents 12 weeks prior to enrollment
* Other hematological disorders
* Upper or lower GI bleed within the prior 6 months

Primary outcomes:
measure: Haemoglobin values to be maintained at greater than 11.0 g/dL during the evaluation period.
timeFrame: 33 weeks
Secondary outcomes:
measure: Q2W doses over duration of study.
timeFrame: 33 weeks
measure: Hb values during the evaluation period.
timeFrame: 33 weeks
measure: adverse events during study
timeFrame: 33 weeks
measure: Hb Rate of Rise during study and excursions above 14g/dL
timeFrame: 33 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References: