louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01124227: Peritoneal Dialysis in Congestive Heart Failure
Official title: Symptomatic Improvement by Peritoneal Dialysis in Patients With End Stage Congestive Heart Failure
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Congestive Heart Failure
Keywords: Congestive Heart Failure
Peritoneal Dialysis
Symptomatic improvement
Renal function
Lead sponsor: Martini Hospital Groningen
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
name: Roche BV Netherlands
First posted: 2010-05-17
Enrollment: 26
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: Rationale: End-stage congestive heart failure is a serious invalidating condition with a poor prognosis and increasing incidence. Non-randomized observations showed peritoneal dialysis (PD) in these patients to improve clinically from NYHA stadium III-IV to as low as NYHA stadium I-II. A randomized trial is needed to test whether PD improves symptoms in this condition and to find an optimal scheme.

Objective: To improve symptomatology in severe chronic failure patients. Study design: Open, parallel intervention trial comparing 2 schemes of peritoneal dialysis with icodextrin (Extraneal®) with standard medical therapy..

Study population: Patients with chronic refractory left ventricular congestive heart failure (LVEF \< 30%, older than 18 years).

Intervention: Peritoneal dialysis with one (night) or two (night and day) dwells with icodextrin (Extraneal®).

Main study parameters/endpoints: Reduction in NYHA classification of symptomatic Congestive Heart Failure at 8 months after start of PD therapy. Burden of congestive heart failure: measured by reduction in unfavorable days (noted by patients in diaries and including days of hospitalization for CHF-deterioration and death).


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Refractory Left Ventricular Congestive Heart Failure: LVEF \< 30%
* Diminished renal function: eGFR \< 60 ml/min
* Clinically volume overloaded (Dyspnoea (NYHA III-IV), edema, and/or ascites)
* Hospitalization for CHF during the last 6 months
* Patient is on optimal cardiologic medical therapy, which has been stable for more than 4 weeks
* Suitable for PD

Exclusion Criteria:

* Hypotension (SBP \< 100 mmHg / MAP \< 70) mmHg
* Instable AP or recent (\< 6 months) myocardial infarction.
* Contraindications for PD (e.g. visual handicap, social)
* Liver failure
* COPD Gold class IV
* Malignancy with life expectancy \< 2 years
* Non compliance
* No informed consent
* Poor mental health

Primary outcomes:
measure: Number of patients in NYHA class I, II, III, or IV as measure of quality of life
timeFrame: 8 months
Secondary outcomes:
measure: Quality of life measures
timeFrame: 8 months
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: Martini Hospital
Study officials:
affiliation: Martini Hospital
name: Wilbert M Janssen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02432027: Trial to Evaluate Topical C-82 in a Psoriasis Plaque Test
Official title: A Single-Center, Randomized, Observer Blind, Vehicle- and Comparator-controlled Trial to Evaluate the Antipsoriatic Efficacy and Safety of Topical Formulations of C-82 in a Psoriasis Plaque Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Psoriasis
Lead sponsor: Prism Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-05-01
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the effects of topical C-82 in a psoriasis plaque test.

Detailed description: The primary objective of this trial is to evaluate antipsoriatic efficacy of the C-82 topical gel compared with vehicle by measurement of the thickness of the Echo Lucent Band (ELB) of the psoriatic infiltrate using 20 MHz sonography. To gain additional information about possible efficacy the change of the test fields compared to untreated plaque will be clinically assessed by visual scoring.

Eligibility criteria: Inclusion Criteria:

* mild to moderate chronic stable plaque type psoriasis
* plaques thickness of at least 200 µm
* lesion(s) on the trunk or extremities (excluding palms/soles)
* skin must be without disease findings

Exclusion Criteria:

* other skin disease
* psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, psoriasis arthropathica and pustular psoriasis
* treatment with any locally acting medications (including anti-psoriatics like vitamin D analogues, dithranol) within 2 weeks preceding and during the trial
* treatment with any systemic medications (including anti-psoriatics like corticosteroids, cytostatics or retinoids) or medications which are known to provoke or aggravate psoriasis (e.g. beta-blocker, anti-malarial drugs, lithium) or phototherapy/PUVA within 4 weeks preceding and during the trial
* treatment with any biologics within 3 months preceding and during the trial
* known allergic reactions, irritations or sensitivity to the active ingredients or other components of the investigational products (e.g. Carbomere 940, propylene glycol)
* drug or alcohol abuse
* symptoms of a clinically significant illness within 4 preceding and during the trial
* participation another clinical trial within 4 weeks of this clinical trial

Primary outcomes:
measure: antipsoriatic efficacy of the C-82 topical gel compared with vehicle by measurement of the thickness of the Echo Lucent Band (ELB) of the psoriatic infiltrate
timeFrame: day 12
Secondary outcomes:
measure: antipsoriatic efficacy compared to control by clinical assessment using a 5-point score.
timeFrame: Day 8 & Day 12
measure: number of subjects with adverse events
timeFrame: daily through Day 12
Other outcomes:
Locations:
city: Schwerin
country: Germany
Study officials:
affiliation: Klinische Forschung Schwerin GmbH
name: Elisabeth Theis, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03856827: A Study of IW-6463 in Healthy Volunteers
Official title: A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics of IW-6463 When Administered to Healthy Volunteers as Single Ascending Doses, as Multiple Ascending Doses, and Under Fed Versus Fasting Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Other
Lead sponsor: Tisento Therapeutics
Sponsor class: INDUSTRY
First posted: 2019-02-27
Enrollment: 110
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: Stage 1: To assess the safety and tolerability of single-ascending-dose levels of IW-6463 tablets when administered orally to healthy subjects

Stage 2: To assess the safety and tolerability of multiple-ascending-dose levels of IW-6463 tablets administered orally to healthy subjects

Stage 3: To assess the safety and tolerability of a single dose of IW-6463 when administered to health subjects in fed vs fasted states and explore the effects of food on IW-6463 pharmacokinetics (PK)


Eligibility criteria: Inclusion Criteria:

* Subject is an ambulatory adult between 18 and 64 years old at the screening visit with the exception of the elderly cohort, who must be 65 years or older at the screening visit.
* Subject is in good health and has no clinically significant findings on physical examination
* Women of reproductive potential must have a negative pregnancy test at the time of check-in and must agree to use protocol-specified contraception throughout the duration of the study and for 3 months after the final dose of study drug
* Men must agree to use protocol-specified contraception and also to not donate sperm throughout the study and for 3 months after the final dose of study drug
* Other inclusion criteria per protocol

Exclusion Criteria:

* Any active or unstable clinically significant medical condition
* Use of any prescribed or non-prescribed medication
* Other exclusion criteria per protocol

Primary outcomes:
measure: After single ascending doses, number of subjects with treatment-emergent adverse events (TEAEs) in the IW-6463 dose-level cohorts vs the (pooled) placebo group.
timeFrame: Up to 9 days
measure: After multiple ascending doses, number of subjects with TEAEs in the IW-6463 dose-level cohorts vs the (pooled) placebo group.
timeFrame: Up to 32 days
measure: After a single dose, number of subjects with TEAEs in the fed vs fasted dosing period
timeFrame: Up to 28 days
measure: Plasma concentration of IW-6463 after single-dose administration under fed vs fasted conditions
timeFrame: Up to 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Centre for Human Drug Research
Study officials:
affiliation: Cyclerion Therapeutics, Inc
name: Chad Glasser, PharmD
role: STUDY_DIRECTOR
affiliation: Centre for Human Drug Research
name: Geert J Groeneveld, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01070927: An Exploratory Study of RO4929097 in Patients With Recurrent or Refractory Non-Small Cell Lung Cancer
Official title: An Exploratory Study on Anti-tumour Activity of Orally Administered RO4929097, a Gamma-secretase Inhibitor, as a Single Agent in Patients With Recurrent or Refractory Non-Small Cell Lung Cancer (NSCLC).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-02-18
Enrollment: 7
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: This study will evaluate the anti-tumour activity, safety and tolerability of RO4929097 as monotherapy in patients with recurrent or refractory non-small cell lung cancer. Patients will receive oral doses of RO4929097 of 80mg (cohort 1) or recommended Phase II dose (cohort 2) on a 3 days on 4 days off schedule. Anticipated time on study treatment is until disease progression or unacceptable toxicity. Target sample size is \<50.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>/= 18 years of age
* stage IIIB/IV recurrent or refractory non-small cell lung cancer
* at most 2 lines of prior therapy in the metastatic setting (first line: platinum containing regimen and bevacizumab; second line: EGFR-targeted therapy)
* ECOG performance status 0-2
* adequate liver, renal and bone marrow function

Exclusion Criteria:

* prior chemotherapy or radiotherapy \</= 4 weeks before first dose of study drug
* history of other malignancy within the past 2 years, except for basal cell skin carcinoma or in situ cervical carcinoma
* history of CNS metastases or leptomeningeal metastases, except for clinically stable disease
* serious cardiovascular illness

Primary outcomes:
measure: Tumour blood flow and tumour metabolic response rate
timeFrame: PET and CT assessments on day 4 (cycle 1) and day 16 (cycles 1 and 2)
Secondary outcomes:
measure: Pharmacokinetic profile and pharmacodynamic parameters (e.g. changes in circulating endothelial and hematopoietic precursors)
timeFrame: pharmacokinetics: cycle 1 on days 1, 2, 4, 10, 11, 16; cycle 2 on days 1, 2, 16\npharmacodynamics: cycle 1 on days 1, 2, 4, 11, 16; cycle 2 on days 1, 16
measure: Tumour response according to RECIST criteria
timeFrame: assessments once every 2nd cycle on day 16
measure: Safety and tolerability: AEs, laboratory parameters
timeFrame: throughout study, laboratory assessments on days 1, 8 and 15 of each cycle
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01022060: Renalof in the Dissolution of Renal Calculi in Patients With Recurrent Calcic Lithiasis
Official title: Efficacy of Renalof in the Dissolution of Renal Calculi in Patients With Recurrent Calcic Lithiasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Recurrent Calcic Urolithiasis
Keywords: Dietary supplement
Renalof
Recurrent calcic urolithiasis
Renal calculi
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2009-12-01
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Renalof administration promotes partial or total dissolution of urinary calculi and improves physicochemical parameters and metabolic activity in patients with recurrent calcic urolithiasis. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of patients to be recruited and randomized for the study is 110. Ultrasonographic and humoral parameters will be assessed every 4 weeks.


Eligibility criteria: Inclusion Criteria:

* Idiopathic calcic lithiasis
* Calculus size lesser than or equal to 2.0 cm (0.79 inches)
* Signed informed consent

Exclusion Criteria:

* Calculus size greater than 2,0 cm (0.79 inches)
* Pregnancy
* Malignant neoplastic conditions
* Previous treatment for destruction of calculi in the urinary tract

Primary outcomes:
measure: Size of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment)
timeFrame: 12 weeks
measure: Number of calculi at week 12 (end of the treatment); week 0 refers to the beginning of treatment
timeFrame: 12 weeks
measure: Lithiasic activity at week 12 (end of the treatment); week 0 refers to the beginning of treatment
timeFrame: 12 weeks
Secondary outcomes:
measure: Calciuria at week 12
timeFrame: 12 weeks
measure: Uricosuria at week 12
timeFrame: 12 weeks
measure: Blood Uric acid at week 12
timeFrame: 12 weeks
measure: Oxaluria at week 12
timeFrame: 12 weeks
measure: Citraturia at week 12
timeFrame: 12 weeks
measure: Phosphatemia at week 12
timeFrame: 12 weeks
measure: Calcemia at week 12
timeFrame: 12 weeks
measure: Total plasmatic calcium at week 12
timeFrame: 12 weeks
measure: Blood ionic calcium at week 12
timeFrame: 12 weeks
measure: Calcium Oxalate crystallization risk at week 12
timeFrame: 12 weeks
measure: Calcium phosphate activity product at week 12
timeFrame: 12 weeks
measure: Calcium Oxalate activity product at week 12
timeFrame: 12 weeks
measure: pH of urine at week 12
timeFrame: 12 weeks
measure: Presence of adverse effects at any moment of treatment
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Havana City
country: Cuba
facility: Institute of Nephrology
state: Havana
Study officials:
affiliation: Institute of Nephrology
name: Mirna Atiés Sánchez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00295360: Expression of BCRP in Icteric Patients
Official title: Influence of Cholestasis on Intestinal BCRP Expression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Icterus
Keywords: cholestasis
BCRP
multidrug resistance
duodenum
bile acids
ABCG2
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2006-02-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: The expression of transporters involved in bile acid homeostasis is differentially regulated during obstructive cholestasis. Bile acids are also substrates of the drug efflux transporter breast cancer resistance protein (BCRP) that is highly expressed in the human intestine. Therefore we intend to analyze whether intestinal BCRP expression could be altered during cholestasis.

Detailed description: BCRP is capable of transport bile acids and may indicate that this transporter is involved in bile acid homeostasis. As an efflux pump, it could protect the enterocytes from potential toxic bile acid concentrations. During cholestasis, where the enterohepatic circulation is disrupted, there occurs an adaptive regulation of transporters for bile acids, bilirubin and cholesterol. These changes take place in liver, kidney, as well as in the intestine.

Using real-time RT-PCR analysis we determine BCRP mRNA expression levels in duodenal tissue of healthy subjects and cholestatic patients. BCRP protein levels will be determined by immunohistochemistry.

Healthy subjects and cholestatic patients are enrolled in the study after giving informed consent. Control subjects with an indication for a gastrointestinal tract endoscopy within a cancer-screening program and patients with obstructive cholestasis with an interventional endoscopic retrograde cholangiopancreatography (ERCP) are included in this study. During endoscopy four biopsy specimens are obtained from the distal part of the duodenum. Biopsies are immediately stored at -70°C until further processing.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of obstructive cholestasis (obstructive jaundice was defined on the basis of chemical parameters (bilirubin, g-glutamyltransferase, and alkaline phosphatase) and on imaging procedures (ultrasound and ERCP) demonstrating a dilated bile duct system)
* control subjects had an indication for a gastrointestinal tract endoscopy within a cancer-screening program

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Basel, Department of Research
state: Basel- Stadt
Study officials:
affiliation: Department of Clinical Pharmacology, University Basel
name: Jürgen Drewe, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03102060: Gluten Free Diet in Preventing Graft Versus Host Disease in Patients Undergoing Donor Stem Cell Transplant
Official title: Gluten Free Diet for GVHD Prophylaxis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Graft Versus Host Disease
Hematopoietic Cell Transplantation Recipient
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-04-05
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This pilot clinical trial studies how well a gluten free diet works in preventing graft versus host disease in patients who are undergoing a donor stem cell transplant. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft versus host disease). A gluten free diet may decrease intestinal inflammation and graft versus host disease in patients who are undergoing a donor stem cell transplant.

Detailed description: PRIMARY OBJECTIVES:

I. To determine the rate and severity of gastrointestinal (GI) graft versus host disease (GVHD) in patients assigned to, and compliant with, a gluten free diet (GFD) during initial transplant hospitalization.

SECONDARY OBJECTIVES:

I. To determine the tolerance of, and compliance with, a GFD in patients undergoing allogeneic hematopoietic stem cell transplant (allo-SCT).

OUTLINE:

Patients undergo a gluten free diet for 30 days during initial hospitalization for allo-SCT, from the time of admission to discharge.

After completion of study, patients are followed up at 1, 3, 6, and 12 months.

Eligibility criteria: Inclusion Criteria:

* Patient undergoing an allo-SCT
* No history of celiac disease or non-celiac gluten sensitivity
* Male and female and all ethnic groups are eligible

Exclusion Criteria:

* Pregnant women
* Children are not eligible as the transplant program is certified as an adult only transplant program

Primary outcomes:
measure: Rate and severity of stage 2-4 GI acute (a)GVHD as determined by microbiome analysis of stool samples
timeFrame: Up to 12 months post allo-SCT
measure: Rate and severity of all grade aGVHD and chronic GVHD as determined by microbiome analysis of stool samples
timeFrame: Up to 12 months post allo-SCT
measure: Rate of compliance with GFD
timeFrame: Up to 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers Cancer Institute of New Jersey
name: Roger Strair
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02704260: Genetic of SportS Induced Endofibrotic Remodeling
Official title: Endofibrose Vasculaire et génétique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Genetic Syndrome
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2016-03-09
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: search for a genetic cause of vascular endofibrose

Detailed description: Perform a DNA analysis to mark the existence of mutations in one or more genes encoding proteins involved in vascular remodeling high.

5 patients or relatives of patients topics

Eligibility criteria: Inclusion Criteria:

* High level reached Cyclists vascular endofibrose
* Cyclist high level and not sick with a brother or sister is senior cyclist reaches the vascular endofibrose.

Exclusion Criteria:

* not obtaining consent

Primary outcomes:
measure: Presence of mutations or nucleotides variations
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital
Study officials:
affiliation: UH ANGERS
name: PIERRE ABRAHAM, PROFESSOR
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06114160: Knowledge of Pregnant Women Concerning Pertussis, Vaccination Against Pertussis and Cocooning Strategy
Official title: Knowledge of Pregnant Women Concerning Pertussis, Vaccination Against Pertussis and Cocooning Strategy
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pertussis
Keywords: cocooning strategy
pertussis
pregnancy
vaccination against pertussis
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2023-11-02
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant women

Brief summary: In France, it has been recommended since 2022 that pregnant women be vaccinated against pertussis from 20 to 36 weeks' gestation.

This vaccination schedule is inspired by the Anglo-Saxon model and studies showing the effectiveness of this practice.

The aim of this vaccine is to protect the newborn by transferring antibodies from the fetus to the placenta, because Pertussis is a particularly serious disease in newborns.

Detailed description: The aim is to describe pregnant women's knowledge concerning pertussis, vaccination against pertussis during pregnancy and the cocooning strategy.

Eligibility criteria: Inclusion Criteria:

* Pregnant between 20 and 41 weeks of amenorrhea
* Primiparous
* aged more than 18
* Agreed to participate in the study

Exclusion Criteria:

* Multiparous
* Protected by law (guardianship, guardianship, safeguarding of justice)
* Not agreed to participate in this study

Primary outcomes:
measure: recommendation of vaccination against pertussis
timeFrame: day0
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: CHU de Reims
name: Pilet Caroline, midwife
role: PRINCIPAL_INVESTIGATOR
References: