louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01688024: Mitomycin C Therapy for Patients With Primary Sclerosing Cholangitis
Official title: Phase 2 Study of Mitomycin C Therapy for Biliary Strictures in Patients With Primary Sclerosing Cholangitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Primary Sclerosing Cholangitis
Keywords: mitomycin C
Lead sponsor: Li, Zhiping, M.D.
Sponsor class: INDIV
Collaborators: name: Johns Hopkins University
First posted: 2012-09-19
Enrollment: 130
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: The purpose of this study is to determine the effectiveness and safety of mitomycin C in the treatment of primary sclerosing cholangitis (PSC).


Eligibility criteria: Inclusion Criteria:

* Ages 18 or older
* Previously established diagnosis of primary sclerosing cholangitis

Exclusion Criteria:

* American Society of Anesthesiologists class 4 or greater
* Serum creatinine \>= 1.7 mg/dL, eGFR \<= 30 mL/min, or dialysis dependence
* Serum hemoglobin \<= 7 g
* Left ventricular ejection fraction \<= 30%
* Dyspnea with minimal exertion (or supplemental oxygen dependence)
* History of bone marrow disease
* Prior recipient of organ transplantation
* Ongoing chemotherapy
* Obstruction of the upper GI tract
* Pregnant or lactating
* Inability to provide informed consent

Primary outcomes:
measure: Therapeutic Effect on Disease Prognosis as Determined by the Mayo Natural History Model for Primary Sclerosing Cholangitis
timeFrame: Two years
Secondary outcomes:
measure: Number of Patients with Adverse Events
timeFrame: Two years
measure: Frequency of Endoscopic Interventions Needed to Manage Disease-related Complications
timeFrame: Two years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Zhiping Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03315624: Safety and Clinical Performance of a Dialyzer With a Modified Polysulfone Membrane
Official title: Safety and Clinical Performance of a Dialyzer With a Modified Polysulfone Membrane - eMPORA Study (Modified POlysulfone membRAne)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Failure
End Stage Renal Disease
Keywords: Hemodialysis
Hemodiafiltration
Renal replacement therapy
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
First posted: 2017-10-20
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Intervention model description: Prospective, open, controlled, cross-over (with randomized treatment sequences), interventional, multi-center
Primary purpose: TREATMENT

Brief summary: The clinical investigation will be performed to generate clinical data on clearances and removal rates (for ß2-microglobulin, myoglobin, phosphate, creatinine, and urea) as well as biocompatibility of the modified polysulfone membrane to obtain CE-certification according to the European Medical Device Directive for the FX Coral 600 (TD 16-1) dialyzer.

Detailed description: The FX Coral (TD 16-1) dialyzer is a new development with a modified polysulfone membrane and is not CE marked yet. The purpose of the clinical evaluation is to generate clinical data for the CE approval.

Eligibility criteria: Inclusion Criteria:

* Minimum age of 18 years
* Informed consent signed and dated by study patient and investigator / authorized physician
* Ability to understand the nature and requirements of the study

Exclusion Criteria:

* Any condition which could interfere with the patient's ability to comply with the study. This decision is at the discretion of the treating physician and relates to the general good condition of the patient (e.g. absence of any acute condition, e.g. infection or mental problem which might give reason for concern etc.).
* Ongoing participation in an interventional clinical study during the preceding 30 days
* Previous participation in this study
* Pregnancy (pregnancy test will be conducted with female patients aged less or aged 55 years) or lactation period

Primary outcomes:
measure: Removal rate of 2-microglobulin
timeFrame: t=240 min. of HDF
Secondary outcomes:
measure: Clearance of ß2-microglobulin
timeFrame: t=60 min. of HDF
measure: Removal rates of myoglobin
timeFrame: t=240 min. of HDF
measure: Clearances of myoglobin
timeFrame: t= 60 min. of HDF
Other outcomes:
Locations:
city: Gießen
country: Germany
facility: Georg-Haas-Dialysezentrum der PHV
Study officials:
affiliation: Georg-Haas-Dialysezentrum der PHV, Giessen, Germany
name: Stephan Wagner, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02057224: Metabolic and Cardiovascular Effects of Renal Denervation
Official title: Metabolic and Cardiovascular Effects of Renal Denervation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Insulin Resistance
Hypertension
Keywords: Renal denervation
Hypertension
Insulin resistance
Adipose tissue function
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2014-02-07
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Renal denervation has recently shown to improve glucose metabolism and insulin sensitivity in addition to reducing blood pressure. The mechanisms are however unclear. The investigators hypothesize that renal denervation alters adipose tissue function by reduced sympathetic outflow, measured by fat biopsies and markers of inflammation and insulin sensitivity. 15 clinical patients undergoing renal denervation are recruited to the study investigating anthropometry, peripheral blood samples, body composition, heart rate variability and subcutaneous fat biopsies at baseline and 6 months after renal denervation.

Detailed description: Renal denervation, a catheter-based approach to reduce renal sympathetic afferent and efferent activity has been used successfully to treat drug-resistant hypertension. Previous studies has demonstrated a reduction of muscle sympathetic nerve activity and renal and total body noradrenaline spillover. In addition, renal denervation seems to improve glucose metabolism and insulin sensitivity, representing the first potential nonpharmaceutical approach for treating insulin resistance. However, the mechanisms are unclear. There is a clear relationship between sympathetic overactivity and insulin resistance. Activation of the sympathetic nervous systems contributes to insulin resistance and metabolic disorders and insulin itself induces sympathetic overactivity. One possible explanation to improved glucose metabolism after renal denervation is altered adipose tissue function (due to the reduction in sympathetic activity). Therefore,15 individuals undergoing renal denervation are recruited. The clinical study includes anthropometry, peripheral blood samples, body composition, heart rate variability and subcutaneous fat biopsies before renal denervation and after 6 months.

Eligibility criteria: Inclusion Criteria:

* Essential hypertension
* Systolic blood pressure \>160 mm Hg despite ≥3 antihypertensive drugs
* Clinical patients accepted for renal denervation

Exclusion Criteria:

* Type 1 diabetes
* Pregnancy
* Glomerular filtration rate ≤45 ml/min/1,73 m2
* Pacemaker/ICD
* Myocardial infarction/stroke the last 12 months

Primary outcomes:
measure: Adipose tissue function
timeFrame: 6 months after renal denervation
Secondary outcomes:
measure: Heart rate variability
timeFrame: 6 months after renal denervation
measure: Body composition
timeFrame: 6 months after renal denervation
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University
Study officials:
References:
Clinical trial NCT02245724: Stem Cell Therapy in Mental Retardation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Mental Retardation
Keywords: Mental retardation
Autologous mononuclear cell therapy
Stem cell
Lead sponsor: Neurogen Brain and Spine Institute
Sponsor class: OTHER
First posted: 2014-09-22
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to analyze the benefit of autologous mononuclear cell therapy in mental retardation.


Eligibility criteria: Inclusion Criteria:

* diagnosed cases of mental retardation
* age above 6 months

Exclusion Criteria:

* presence of acute infections such as Human immunodeficiency virus/Hepatitis B Virus/Hepatitis C Virus
* malignancies
* bleeding tendencies
* pneumonia
* renal failure
* severe liver dysfunction
* severe anemia \[Hemoglobin \< 8\]
* any bone marrow disorder
* space occupying lesion in brain
* other acute medical conditions such as respiratory infection and pyrexia

Primary outcomes:
measure: Change in common clinical symptoms of mental retardation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Navi Mumbai
country: India
facility: Neurogen brain and spine institute
state: Maharashtra
Study officials:
References:
citation: Sharma A, Sane H, Gokulchandran N, Pai S, Kulkarni P, Ganwir V, Maheshwari M, Sharma R, Raichur M, Nivins S, Badhe P. An open-label proof-of-concept study of intrathecal autologous bone marrow mononuclear cell transplantation in intellectual disability. Stem Cell Res Ther. 2018 Jan 31;9(1):19. doi: 10.1186/s13287-017-0748-2.
Clinical trial NCT03718624: A Study of Intraperitoneal and Intravenous Paclitaxel Plus Apatinib and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells
Official title: A Study of Intraperitoneal and Intravenous Paclitaxel Plus Apatinib and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer With Positive Exfoliative Cancer Cells
Lead sponsor: Hebei Medical University
Sponsor class: OTHER
First posted: 2018-10-24
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the efficacy and safety of intraperitoneal and intravenous paclitaxel plus apatinib and S-1 in the conversion therapy of gastric cancer with positive exfoliative cancer cells


Eligibility criteria: Inclusion Criteria:

1. Untreated (e.g. chemotherapy, radiotherapy and other antitumor therapy);
2. Age:18 to 70 years old;
3. Man or female (except pregnant and lactating women);
4. Confirmed to gastric adenocarcinoma;
5. Proven gastric cancer of T stage was T3 and T4, and no distant metastasis was observed. The exfoliative cancer cells detection in peritoneal washes was positive;
6. Blood cell count has to meet the following criteria:

   WBC≥3.5×109/L; ANC≥1.5×109/L; PLT≥100×109/L; HB≥90g/L;
7. Liver/kidney function has to meet the following criteria:

   ALT and AST≤2.5\*ULN TBIL\<1.5\*ULN； Serum creatinine ≤1.5\*ULN;
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
9. Participants were willing to join in this study, good adherence and written informed consent.

Exclusion Criteria:

1. Patients with other malignant tumors within 5 years;
2. Metastasis was found to be visible to the naked eye;
3. It has serious or uncontrolled heart diseases and infections (Including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction less than 50%, poor-controlled hypertension and so on);
4. History of psychiatric drugs abuse and can't quit or patients with mental disorders;
5. Patients with severe or uncontrollable mental illness;
6. Patients with tendency of gastrointestinal bleeding, including the following: a local active ulcerative lesions, and defecate occult blood (+ +).Has melena and hematemesis in two months;
7. Pregnant or lactating women;
8. It have serious harm to the patient's safety or affect the patients who have completed the research.
9. The researchers think inappropriate.

Primary outcomes:
measure: R0-resection rate
timeFrame: within 3 weeks after surgery
measure: Conversion to negative rate
timeFrame: within 3 weeks after surgery
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 5years
measure: Progression free survival (PFS)
timeFrame: 5years
measure: Adverse events
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06946524: A Study to Assess the Bioavailability of Risankizumab Following Subcutaneous Administration With Prefilled Pen Relative to a Prefilled Syringe in Healthy Adult Participants
Official title: A Phase 1 Pharmacokinetic Study in Healthy Subjects to Evaluate the Bioavailability of Risankizumab Following Subcutaneous Administration With Prefilled Pen Relative to Prefilled Syringe
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
Risankizumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2025-04-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will assess the pharmacokinetics, relative bioavailability, immunogenicity, safety, and tolerability of risankizumab following subcutaneous (SC) administration with a prefilled pen or a prefilled syringe in healthy adult participants.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at the time of screening and upon initial confinement. BMI is calculated as weight in kg divided by the square of height measured in meters.
* Body weight greater than 40 kg and less than 100 kg at screening and upon initial confinement.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG

Exclusion Criteria:

* Previous exposure to any anti-interleukin-12/23 or anti interleukin-23 treatment for at least one year prior to Screening.
* Intention to perform strenuous exercise to which the participant is unaccustomed within one week prior to administration of first dose of study drug and during the study.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of Risankizumab
timeFrame: Up to approximately 141 days
measure: Time to Cmax (Tmax) of Risankizumab
timeFrame: Up to approximately 141 days
measure: Apparent Terminal Phase Elimination Rate Constant (β) of Risankizumab
timeFrame: Up to approximately 141 days
measure: Terminal Phase Elimination Half-life (t1/2) of Risankizumab
timeFrame: Up to approximately 141 days
measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Last Measurable Concentration (AUCt) of Risankizumab
timeFrame: Up to approximately 141 days
measure: Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to Infinity (AUCinf) of Risankizumab
timeFrame: Up to approximately 141 days
measure: Number of Participants Experiencing Adverse Events
timeFrame: Up to approximately 141 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Altasciences Clinical Los Angeles /ID# 276446
state: California
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05229224: Pilot Study of the Osteo-Fluidic-Sensitive (OFS) in Tension-type Headache.
Official title: Evaluation of the Efficacy of the Osteo-Fluidic-sensitive (OFS) Versus Placebo Method in the Management of Frequent Episodic Tension-type Headache. Pilot Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tension-Type Headache Episodic
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2022-02-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis of the study is the Osteo-fluidic-Senstive is effective for lowering headache pains (Reduction of the number of days of headaches per month) for patients having frequent episodic tension-type headache. The OFS method will improve quality of life and will reduce the consumption of crisis treatments.

Compare the efficacy of the Osteo-Fluidic-Sensitive method versus a placebo method on patients with tension type headache for the reduction of the number of days of headaches per month after 3 months of treatment at Centre Hospitalier Universitaire de Poitiers.


Eligibility criteria: Inclusion Criteria:

* 18 and 75 years' old
* Person having highly frequent episodic tension type headache (between 2 and 14 days of headaches per month) associated or not to headache with characteristic of a migraine per International Classification of Headache Disorders 3rd edition criteria
* Person who completed his headache agenda the month before the study.
* Patient who understands and accepts the effects of the study
* Signed consent
* Person with health insurance coverage

Exclusion Criteria:

* Person having secondary or primary headaches (chronic tension type headache, migraines only, Cluster headaches, Neuralgias ...)
* Person on treatment of venlafaxine, gabapentine, duloxetine, clomipramine et toxine botulique.
* Concomitant participation to another clinical research
* Pregnant or lactating women, women of child-bearing age who do not have effective contraception.
* People with reinforced protection (juvenile), people deprived of liberty per justice or administrative decision, people living in a sanitary and social establishment, adults under legal protection and people in critical medical conditions

Primary outcomes:
measure: numbers of days with headaches
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU Poitiers
Study officials:
affiliation: CHU de Poitiers FRANCE
name: Helene KERSUZAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02630524: Diet Composition and Cardiometabolic Risk Reduction in Adults With SCI
Official title: Diet Composition and Cardiometabolic Risk Reduction in Adults With SCI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Spinal Cord Injuries
Diabetes
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2015-12-15
Enrollment: 48
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the effectiveness of a low carbohydrate diet on increasing dietary adherence and improving cardiometabolic risk factors among adults with spinal cord injury (SCI). Seventy overweight/obese adults with SCI will be randomized to one of two groups: 1) a reduced carbohydrate diet or 2): a "standard" diet (STD). Participants will take part in a 6-month behavioral lifestyle intervention implemented through a novel eHealth platform specially designed for individuals with SCI.


Eligibility criteria: Inclusion Criteria:

* SCI ≥ 1 year post injury
* able to use arms for exercise
* BMI of 22-50 kg/m2
* 19-60 years old
* reliable access to internet and smartphone
* have the ability to converse in English
* ability to prepare own food or have input into person responsible for food preparation

Exclusion Criteria:

* heart disease
* renal disease
* active pressure sore
* persons on medically restricted diets

Primary outcomes:
measure: Adherence to prescribed macronutrient composition as measured by multiple pass 24 hour dietary recall
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Lakeshore Foundation
state: Alabama
Study officials:
References:
Clinical trial NCT01816724: Spanish (Spain) Validation of a Specific Symptomatic Questionnaire for Patients With Nocturia
Official title: Spanish (Spain) Validation of a Specific Symptomatic Questionnaire for Patients With Nocturia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nocturia
Keywords: NOCTURIA
SYMPTOMATIC QUESTIONNAIRE
N-QOL
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2013-03-22
Enrollment: 129
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men older than 60 years old suffering from nocturia (one or more voidings overnight) without exclusion criteria

Brief summary: The objective of this study is to validate the spanish (from Spain) version of the "Nocturia Quality of Life Questionnaire and assess their psychometric properties, using the spanish translation provided by the copyright holder.

Internal consistency (measured by Alpha cronbach coefficient), Reproductibility (measured by Intraclass Correlation Coefficient), Convergent Validity (assessed using other already validate questionnaires such the International Prostate Symptom Score (IPSS), King's Health and Pittsburgh Sleeps Quality Index questionnaires) and Discriminant Validity will be evaluated.


Eligibility criteria: Inclusion Criteria:

* Men and women
* Older than 60 years old
* One or more voidings overnight

Exclusion Criteria:

* Sleep disturbances
* Psychiatric diseases
* Surgical procedures during the time of study
* Introduction of new pharmacological treatments during the time of study
* Inability to complete the questionnaires

Primary outcomes:
measure: score in n-QoL questionnaire
timeFrame: two determinations in ten days
Secondary outcomes:
measure: score in IPSS spanish validated questionnaire
timeFrame: two determinations in ten days (only men)
measure: score in Pittsburgh Sleep Quality Index spanish validated questionnaire
timeFrame: two determinations in ten days
measure: score in King's health spanish validated questionnaire
timeFrame: two determinations in ten days
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Hospital Universitario Parc Tauli
state: Barcelona
Study officials:
References:
Clinical trial NCT00976924: Clinical Test of Blood Glucose Test Strips
Official title: Clinical Test of Blood Glucose Test Strips
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: blood glucose
Lead sponsor: Andon Medical Co.,Ltd
Sponsor class: INDUSTRY
First posted: 2009-09-15
Enrollment: 200
Sex: ALL
Minimum age (years): 22
Maximum age (years): 78
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Blood glucose test strips are tested with the test meters to test the accuracy of the blood pressure monitoring function.


Eligibility criteria: Inclusion Criteria:

* The patients with blood glucose within the range of ISO15197

Exclusion Criteria:

* The patients with blood glucose out of the range of ISO15197

Primary outcomes:
measure: blood glucose value
timeFrame: 5 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University general hospital
state: Tianjin
Study officials:
References: