louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06786260: Di-PKD: A Pilot Trial of Dietary Intervention in Patients With Autosomal Dominant Polycystic Kidney Disease
Official title: Di-PKD: A Pilot Trial of a 12-Month Targeted Dietary Intervention on Cyst Progression in Patients With Autosomal Dominant Polycystic Kidney Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Keywords: ADPKD
Diet
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2025-01-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this interventional study is to evaluate the impact of a specific diet (low salt, limited caffeine, high potassium, low phosphate, limited protein, limited carbohydrate intake, adequate water intake) on changes in serum and urinary biomarkers, total kidney volume (TKV), and cyst progression in subjects with autosomal dominant polycystic kidney disease (ADPKD).

Researchers will compare the results of subjects in the study diet (interventional) arm to the results of subjects in the regular diet (control) arm.

Detailed description: 15 subjects will be enrolled in each dietary arm for a total of 30 subjects. All subjects will follow the study diet for one week, after which serum and urinary biomarkers will be measured. A baseline evaluation, including genetic testing, MRI, Mayo Clinic Imaging Classification and 10-question survey will also be conducted. After Week 1 of the study, subjects will be assigned to the intervention or control arm. Subjects will have six follow-up visits at months 1, 2, 3, 6, 9 and 12 to assess adherence to diet. Serum and urinary biomarkers will be repeated at each visit. MRI will be repeated at Month 12.

Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of ADPKD
* Genetic testing confirmation of PKD1 or PKD2
* eGFR \>30mL/1.73m2
* Willingness to adhere to a preconditioning diet for 1 week and ability to complete the study
* Mayo Clinic Imaging Classification (MCIC): 1C, 1D, 1E

Exclusion Criteria:

* History of dietary non-adherence
* Subjects on Tolvaptan
* Comorbidities that could interfere with participation (Diabetes, Heart Failure (EF\<30%) Advanced Chronic Kidney Disease (CKD) Stage 4 and higher)

Primary outcomes:
measure: Progression of kidney cysts by change in total kidney volume (TKV) from baseline to 12 months
timeFrame: Change between baseline and 12 months
Secondary outcomes:
measure: Progression of kidney cysts as evidenced by urinary biomarkers from baseline to 12 months
timeFrame: Change between baseline and 12 months
measure: Progression of kidney cysts as evidenced by serum biomarkers from baseline to 12 months
timeFrame: Change between baseline and 12 months
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Health
state: California
Study officials:
affiliation: Loma Linda University Health
name: Amir Abdipour, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06972160: Intervention Project to Increase Adherence to Colorectal Cancer Screening in Barcelos/Esposende
Official title: Interventions to Increase Adherence to Colorectal Cancer Screening in Barcelos/Esposende: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Colon and Rectal Cancer
Lead sponsor: Local Health Unit Barcelos/Esposende, Public Health Unit
Sponsor class: OTHER_GOV
Collaborators: name: Instituto de Saude Publica da Universidade do Porto
First posted: 2025-05-14
Enrollment: 1038
Sex: ALL
Minimum age (years): 49
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: An experimental study through a randomized clinical trial, without blinding (for participants and the research team), with a control group (not subject to intervention) and an intervention group (subject to two text messages, an automated non-human call or a call made by the administrative assistant, and a phone call made by a physician).


Eligibility criteria: Inclusion Criteria:

Participants must be registered in the ULS of

Barcelos/Esposende and meet the following criteria:

1. Age between 50 and 74 years.
2. No symptoms such as weight loss in the last 6 months or gastrointestinal symptoms.
3. No prior diagnosis of CRC.
4. No diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease).
5. No family history of CRC in first- and second-degree relatives diagnosed before age 60.
6. No prior fecal occult blood test (FOBT) in the 11 months before receiving the collection kit or no prior sigmoidoscopy or colonoscopy in the last 24 months.

Exclusion Criteria:

1. Participants who did not receive the screening kit at home.
2. Participants without a phone number.
3. Participants who do not answer the phone or refuse to participate in the study.
4. Participants unable to consent or perform the screening due to physical, mental, or other conditions that seriously impair comprehension.

Primary outcomes:
measure: Adherence to colon and rectal screening [Time Frame: 6 weeks]
timeFrame: From April 2025 to June 2025 (6 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Porto
country: Portugal
facility: Public Health Unit Barcelos/Esposende
Study officials:
References:
Clinical trial NCT02145260: Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients
Official title: Randomized Trial of Dialysate Sodium in Chronic Hospitalized Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intra-dialytic Hypotension
Keywords: Hemodialysis
Hypotension
Hospitalization
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2014-05-22
Enrollment: 144
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: Intra-dialytic hypotensive (IDH) events can be defined as an abrupt decline in blood pressure that cause symptoms and/or require an intervention. They are common, affecting up to one third of maintenance HD sessions. Detrimental associations include: development of myocardial stunning, cerebral hypo-perfusion, vascular access thrombosis and greater mortality.

Rapid solute removal by HD generates temporary osmotic gradients between the intra-vascular and intra-cellular compartments, promoting trans-cellular fluid movement and resultant hypotension. Manipulation of osmotic gradients, e.g. using higher dialysate sodium (DNa), may ameliorate excess SBP decline during HD.

This study aims to assess the effects of higher (142 mmol/L) versus lower (138 mmol/L) dialysate sodium (DNa) use in adult chronic hemodialysis patients admitted to hospital on intra-dialytic blood pressure and biomarkers of cardiac ischemia.

The investigators will randomly assign subjects to higher versus lower DNa during their hospital stay, up to a maximum of six HD sessions.


Eligibility criteria: Inclusion Criteria:

* Chronic HD (\>90 days)
* Age ≥18y
* Informed consent
* First admission during study period.

Exclusion Criteria:

* Use of pressors
* Pre-dialysis serum sodium \<=128mmol/L or \> 145 mmol/L
* Pre-dialysis SBP \>180 mmHg
* Intensive care stay earlier in admission
* Expected length of stay \<24 hours (e.g. admission for HD access procedure)
* Acute coronary syndrome within seven days
* Acute stroke
* Institutionalized individuals
* Pregnancy

Primary outcomes:
measure: Change in Intra-dialytic Decline in Systolic Blood Pressure
timeFrame: Average decline in systolic blood pressure will be measured up to a maximum of six inpatient HD sessions, occurring over a two-week time period
Secondary outcomes:
measure: Change in Pre-dialysis High-sensitivity Troponin I
timeFrame: The change in pre-dialysis high sensitivity troponin I concentrations will be measured between the first and second inpatient hemodialysis sessions, occuring over a period of three days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Finnian Mc Causland, MB, MMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03957460: Accuracy of Continuous and Non-invasive Hemoglobin Monitoring
Official title: Accuracy of Continuous and Non-invasive Hemoglobin Monitoring During Laparoscopic Gastrectomy: Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2019-05-21
Enrollment: 20
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The patients were scheduled for laparoscopic gastrectomy and recieved the SpHb monitoring during surgery.

Brief summary: The primary purpose of this observational study is to investigate the accuracy on the continuous and non-invasive hemoglobin monitoring during laparoscopic gastrectomy.


Eligibility criteria: Inclusion Criteria:

* laparoscopic gastrectomy under general anesthesia

Exclusion Criteria:

* atypical hemoglobin disease, infective state, cardiovascular disease, peripheral vascular disease

Primary outcomes:
measure: difference between SpHb value in g/dL and SaHb value in g/dL (SpHb - SaHb)
timeFrame: from the start of anesthesia to the end of anesthesia, an average 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Suwon
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Ajou University School of Medicine
Study officials:
References:
Clinical trial NCT03976960: Clinical and Biological Database in Colon Cancer and Colic Tumors
Official title: Prospective, Multicenter, Clinical and Biological Database Set-up in Colon Cancer and Colic Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer Colon
Keywords: cancer
colon
tumor
colic
Lead sponsor: Institut du Cancer de Montpellier - Val d'Aurelle
Sponsor class: OTHER
First posted: 2019-06-06
Enrollment: 600
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: Developement of a clinical and biological database in colon cancer and colic tumors in order to better understand tumor invasion and metastatic scattering processes. The investigators hope that a better understanding of tumoral invasion process will lead to the discovery of new biomarkers and new drugs.

Detailed description: As the second leading cause of cancer-related death in France, colorectal cancer is a major public health problem. Each year, 37 000 cases are newly diagnosed in France and 17 000 patients die of the disease.

Colorectal cancer is due to molecular and genetic damages involved in all tumorigenesis steps, transition from healthy tissue to adenoma and finally to invasive carcinoma stage. The investigators hope that a to better understand tumor invasion and metastatic scattering processes will allow therapeutic innovation and the emergence of new biomarkers.

However, the study of early tumorigenesis phases as well as advanced stages of the disease is currently limited due to a lack of tissue samples.

In this context, the Montpellier Cancer Institute (ICM) decided to initiate a biological collection dedicated to the tissular and blood samples of patients with colorectal cancer.

Eligibility criteria: Inclusion Criteria:

1. Patient undergoing colon cancer surgery (stage I, II, III and IV)
2. Patient operated for liver or lung or peritoneal carcinomatosis metastases originating from colon cancer
3. Patient operated for pre-neoplastic lesion (adenomatous polyp /villous adenoma polyp),
4. Patient with familial polyposis eligible for colectomy
5. Age \> 18 years
6. Signed informed consent

Exclusion Criteria:

1. Patient not affiliated to Social Protection system
2. Patient unable to understand or comply with study instructions or requirements for psychological, family, social or geographical reasons
3. Patient under guardianship
4. Minor patient

Primary outcomes:
measure: Number of clinical risk factors for colorectal cancer
timeFrame: Until the study completion : 6 years
measure: Number of biological risk factors for colorectal cancer
timeFrame: Until the study completion : 6 years
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHRU de Montpellier
state: Hérault
city: Montpellier
country: France
facility: Institut Régional du cancer de Montpellier
Study officials:
affiliation: Institut régional du cancer de Montpellier
name: ERIC ASSENAT, M.D
role: STUDY_CHAIR
References:
Clinical trial NCT01570660: Phielix et al.: Hepatic Fat Content and Adipokines
Official title: Effects of Glimepiride Monotherapy Versus Combined Neteglinide-Pioglitazone Therapy on Insulin Sensitivity in Type 2 Diabetic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: German Diabetes Center
Sponsor class: OTHER
First posted: 2012-04-04
Enrollment: 24
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Thiazoledinediones decrease blood glucose by their insulin-sensitizing properties. Here the investigators examined whether pioglitazone (PIO) improves insulin sensitivity independently of glycemic control and whether adipokines or non-esterfied fatty acids (NEFA) serve as mediators.


Eligibility criteria: Inclusion Criteria:

* well controlled patients with type 2 diabetes (Hb1Ac \< 8%)
* no insulin therapy
* no co-morbidities
* stable medication use for the last 6 months
* stable body weight the last 6 months
* no diet in the last 6 months

Exclusion Criteria:

* Hb1Ac \> 8%
* insulin therapy
* diabetes-related co-morbidities, like cardiovascular disease, neuropathology
* unstable medication use
* unstable body weight in the last 6 months (\> 5 kg)
* following a diet in the last 6 months

Primary outcomes:
measure: whole body insulin sensitivity
timeFrame: within a minimal of 1 week before the start of the 12 weeks pioglitazone or glimepiride treatment and after the last day of the treatment period.
Secondary outcomes:
measure: intrahepatocellular lipid content
timeFrame: within a minimal of 1 week before the start of the 12 weeks pioglitazone or glimepiride treatment and after the last day of the treatment period.
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Institute for Clinical Diabetology, German Diabetes Center, D-40225, Düsseldorf, Germany; Division of Endocrinology and Metabolism, Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria. Department of Metabolic Diseases, Un
name: Michael Roden, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Phielix E, Brehm A, Bernroider E, Krssak M, Anderwald CH, Krebs M, Schmid AI, Nowotny P, Roden M. Effects of pioglitazone versus glimepiride exposure on hepatocellular fat content in type 2 diabetes. Diabetes Obes Metab. 2013 Oct;15(10):915-22. doi: 10.1111/dom.12112. Epub 2013 May 1.
Clinical trial NCT04689360: An Intermediate Size Expanded Access Protocol of Elamipretide
Official title: An Intermediate Size Expanded Access Protocol of Elamipretide for Subcutaneous Injection in Patients With Genetically Confirmed Rare Diseases With Known Mitochondrial Dysfunction
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Mitochondrial Diseases
Barth Syndrome
Keywords: Barth
Lead sponsor: Stealth BioTherapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Choosing to participate in an expanded access program is an important personal decision. Talk with your doctor to learn more about this program. The treating physician must contact StealthBiotherapeutics using the Expanded Access Program Contacts provided. Elamipretide will only be made available after careful review of an individual request submitted by the treating physician. The initiation and conduct of the treatment with elamipretide for an individual patient, and compliance with this treatment guideline, will be under the full and sole responsibility of the treating physician.


Eligibility criteria: Key Inclusion Criteria:

1. ≥1 year and ≤ 80 years of age or ≥12 years for Barth Syndrome in SPIES-007
2. Patients with genetically confirmed rare primary mitochondrial diseases including Barth Syndrome

   1. observed cardiomyopathy, renal impairment, neuropathic, or ophthalmic manifestation
   2. where such disease is serious or life-threatening and no comparable or satisfactory alternative therapy options available.
3. Patients without genetic confirmation of a rare disease with known mitochondrial dysfunction but do exhibit serious or life-threatening clinical manifestations of mitochondrial dysfunction.
4. Is self-able or has caregiver willing and able to administer SC injection.
5. Would potentially benefit from treatment with elamipretide and cannot be treated satisfactorily with any approved medicinal product in the opinion of the treating physician.

Key Exclusion Criteria:

1. Known hypersensitivity to elamipretide or any excipients.
2. Women who are pregnant, are planning on becoming pregnant, or are breast-feeding.
3. Patients receiving any other investigational agent within 30 days of dosing.
4. Any active, serious psychiatric, medical, or other conditions/situations which, in the treating physician's opinion, could compromise the patient's safety.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02000076: The Stockholm Sleepy Brain Study: Effects of Sleep Deprivation on Cognitive and Emotional Processing in Young and Old
Official title: The Stockholm Sleepy Brain Study: Effects of Sleep Deprivation on Cognitive and Emotional Processing in Young and Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Deprivation
Keywords: Sleep
resting state
functional connectivity
emotional contagion
empathy
emotional regulation
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Stockholm University
First posted: 2013-12-03
Enrollment: 98
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to investigate the effects of partial sleep deprivation (PSD) on resting state brain connectivity, emotional contagion, empathy, and emotional regulation.


Eligibility criteria: Inclusion Criteria:

* 20-30 years of age, inclusive OR 65-75 years of age, inclusive
* Able to understand spoken and written Swedish (in order to understand instructions)
* Normal or corrected-to-normal vision not using glasses
* Not colour blind
* Right-handed
* Free from ferromagnetic objects in body
* No history of any neurologic or psychiatric illness including drug abuse
* No history of diabetes nor hypertension

  * No depression according to ratings using the Hospital Anxiety and Depression scale (HAD)
  * No insomnia according to ratings using the Insomnia Severity Index (ISI) and Karolinska Sleep Questionnaire (KSQ)
* No use of psychotropic drugs
* Not studying or working in medicine, psychology, nor behavioural science
* Not suffering from severe seasonal allergy
* No use of cortisone, anti-histamines, nor any other immune-modulating drugs
* Habitual intake of no more than 4 cups of coffee per day or the equivalent in terms of caffeine
* No daily use of nicotine

Exclusion Criteria:

-

Primary outcomes:
measure: Blood oxygen level-dependent response in amygdala to angry faces (t/z-score from statistical parametric mapping)
timeFrame: Change between 1st and 2nd MRI scanning session (approx. 1 month later)
Secondary outcomes:
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska Institutet, Karolinska Universitetssjukhuset i Solna
state: None/Not Applicable
Study officials:
affiliation: Stockholm University
name: Torbjörn Åkerstedt, PhD
role: STUDY_CHAIR
affiliation: Stockholm University, Karolinska Institutet
name: Mats Lekander, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stockholm University
name: Håkan Fischer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tamm S, Schwarz J, Thune H, Kecklund G, Petrovic P, Akerstedt T, Fischer H, Lekander M, Nilsonne G. A combined fMRI and EMG study of emotional contagion following partial sleep deprivation in young and older humans. Sci Rep. 2020 Oct 21;10(1):17944. doi: 10.1038/s41598-020-74489-9.