louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00132184: Vitamin D Treatment for Crohn´s Disease
Official title: Remission Keeping and Remission Inducing Effect by Vitamin-D in Crohns Disease, and in Vitro Vitamin-D Mediated T-Cell Immunomodulation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Crohns Disease
Keywords: Vitamin D
Crohns Disease
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2005-08-19
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine whether vitamin D treatment is effective in Crohn's disease.

Detailed description: Crohns Disease is an inflammatory disease of primarily the small intestine and colon.

In recent years scientists have hypothesized that low blood vitamin-D levels play a role in the development of autoimmune diseases, including Crohns disease. The purpose of this study is to examine whether vitamin-D is effective in keeping remission in inactive Crohns Disease (double blind placebo controlled trial). The patients who have active disease in the placebo group (reach primary endpoint), will in an open setting receive a higher single dose vitamin-D and the effect will be measured within 4 weeks.

Eligibility criteria: Inclusion Criteria:

* Crohn's disease
* Inactive Crohn's disease for at least 4 weeks
* Crohn's Disease Activity Index (CDAI) \< 150
* C-reactive protein within normal range
* Serum albumin within normal range

Exclusion Criteria:

* Hypercalcemia
* Short bowel syndrome
* Pregnancy

Primary outcomes:
measure: Relapse rate within 1 year treatment; CDAI>220
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Department V
city: Horsens
country: Denmark
facility: Hospital of Horsens
city: Randers
country: Denmark
facility: Hospital of Randers
city: Silkeborg
country: Denmark
facility: Hospital of Silkeborg
Study officials:
affiliation: Aarhus University Hospital
name: Jens F. Dahlerup, MD, DrMedSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06646484: Interest of Impedancemetry in Monitoring Hydration and Hyponatremia During Subarachnoid Hemorrhages
Official title: Interest of Impedancemetry in Monitoring Hydration and Hyponatremia During Subarachnoid Hemorrhages
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Subarachnoid Hemorrhage (SAH)
Keywords: subarachnoid hemorrhage
impedancemetry
hydration
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in the neurological ICU of Louis Pradel Hospital Lyon in the 72h post subarachnoid hemorrhage.

Brief summary: Subarachnoid hemorrhage (SAH) is a rare and serious form of stroke, mainly linked to the rupture of an intracranial aneurysm responsible for bleeding into the meningeal spaces.

The main late serious complication is delayed cerebral ischemia (DCI), resulting in the appearance of new neurological deficits.

Prevention of ICR involves in particular maintaining euvolemia, and early treatment of hyponatremia, itself dependent on the level of volume.

Evaluation of water status and sodium balance is therefore essential. This assessment is complicated and relies on indirect parameters, both clinical and biological.

Impedancemetry, making it possible to measure water volumes and sodium load, could be an aid in the management of blood volume and sodium intake.


Eligibility criteria: Inclusion Criteria:

* Adult man, woman
* Hospitalized following Subarachnoid Hemorrhage within 72 hours of bleeding
* Admitted to the neurological intensive care unit for less than 48 hours
* Being able to understand the ins and outs of the study
* Having expressed his non-opposition

Exclusion Criteria:

* Patients under legal protection
* Pregnancy

Primary outcomes:
measure: Hydration measurements
timeFrame: Every 48 hours during the mean 21 days of stay in the neurological ICU.
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon. Neurological ICU
Study officials:
References:
Clinical trial NCT02209584: Open Registry Measuring Impact of Genomic Testing on Treatment Decision After Biopsy in Newly Diagnosed Prostate Cancer Patients
Official title: An Open Registry to Measure the Impact of Adding Genomic Testing (Prolaris®) on the Treatment Decision Following Biopsy in Newly Diagnosed Prostate Cancer Patients by Specialists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Lead sponsor: Myriad Genetic Laboratories, Inc.
Sponsor class: INDUSTRY
First posted: 2014-08-06
Enrollment: 274
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Recently diagnosed treatment-naïve patients with early stage localized prostate cancer.

Brief summary: This registry is intended to measure the impact of Prolaris® testing on therapeutic decisions when added to standard clinical-pathological parameters in men with newly diagnosed prostate cancer.


Eligibility criteria: Inclusion Criteria:

* Newly diagnosed (≤6 months), untreated patients with histologically proven adenocarcinoma of the prostate that have the following characteristics.
* Clinically localized (no evidence on clinical or imaging studies of advanced disease.
* No hormonal therapy including LHRH agonist or antagonist, anti-androgen, 5-alpha reductase inhibitor, estrogens or exogenous androgens, when applicable.
* Sufficient amount of tissue remains from biopsy to perform genomic testing.

Exclusion Criteria:

* Patients with known history of hypogonadism will be excluded from the registry

Primary outcomes:
measure: Percentage change from the recorded PRE-Prolaris® test treatment option versus the ACTUAL treatment option of genomic risk assessment testing (Prolaris®).
timeFrame: 1 months
Secondary outcomes:
measure: Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan (prior to patient consultation).
timeFrame: 1 month
Other outcomes:
measure: Percentage change from the recorded PRE-Prolaris® test treatment option versus the POST-Prolaris® test treatment plan following consultation with the patient.
timeFrame: 1 month
measure: The mean change in the physician's likelihood of recommending non-interventional therapy (watchful waiting or active surveillance) post-genomic testing compared to pre-genomic testing.
timeFrame: 1 month
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Myriad Genetic Laboratories, Inc.
name: Richard Wenstrup, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06845384: Registry of Acute Coronary Syndrome in the Regional Cardiovascular Center
Official title: Registry of Acute Coronary Syndrome in the Regional Cardiovascular Center
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Аcute Coronary Syndrome
Keywords: acute coronary syndrome
percutaneous coronary intervention
unstable angina
acute myocardial infarction
Lead sponsor: National Medical Research Center for Therapy and Preventive Medicine
Sponsor class: OTHER_GOV
Collaborators: name: Stupino Clinical Hospital, Moscow Region State Medical Institution
First posted: 2025-02-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients consequently admitted to the regional cardiovascular center with a diagnosis of acute coronary syndrome, in order to study the behavior of patients from the first minutes of the onset of the anginal syndrome, and influence of the delay in calling of ambulance on short-term and long-term outcomes of the disease.

Brief summary: The study is a prospective registry of patients consequently admitted to the regional cardiovascular center with a diagnosis of acute coronary syndrome, in order to study the behavior of patients from the first minutes of the onset of the anginal syndrome, and influence of the delay in calling of ambulance on short-term and long-term outcomes of the disease. Other factors which may influence short-term and long-term outcomes will also be assessed.


Eligibility criteria: Inclusion Criteria:

1. Men and women aged 18 and over, permanently residing in the Moscow region and in Moscow.
2. Patients hospitalized in the Regional Vascular Center of Stupino Clinical Hospital (GBUZ MO SKB) with a diagnosis of ACS with and without ST-segment elevation.
3. Signing an informed consent form to participate in the study and the processing of personal data, as well as conducting a telephone survey during the follow-up.

Exclusion Criteria:

1. The patient's refusal to participate in the study and to allow the use of personal data during the study.
2. The presence of mental illness.
3. The patient plans to leave Russia for permanent or long-term residence.

Primary outcomes:
measure: all-cause mortality
timeFrame: 1 year and 3 years
Secondary outcomes:
measure: Сombined secondary end-point
timeFrame: 1 year and 3 years
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: National Medical Research Centre for Therapy and Preventive Medicine
Study officials:
affiliation: National Medical Research Centre for Therapy and Preventive Medicine, Moscow, Russia
name: Sergey Martsevich, D.M., professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT00584584: An Exploratory Study of the Effects of a Single Dose of QAX576 (an Interleukin-13 Monoclonal Antibody) on Simulated Hayfever
Official title: A Proof of Concept Study of the Effects of QAX576 (an Interleukin-13 Monoclonal Antibody) on Allergic Inflammation Following Out of Allergy Season Repeated Nasal Allergen Challenge in Subjects With Seasonal Allergic Rhinitis Sensitive to Timothy Grass Pollen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinitis
Keywords: Allergic rhinitis, adults, monoclonal antibody, interleukin-13.
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-01-02
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate whether a single dose QAX576 (an interleukin-13 monoclonal antibody) gives protection against a model of hayfever


Eligibility criteria: Inclusion Criteria:

* History of allergic rhinitis.

Exclusion Criteria:

* Respiratory disease other than mild intermittent asthma.
* Received immunotherapy in past 3 years.
* History of clinically significant drug allergy.
* History of clinical schistosomiasis or travel within 6 months prior to or following study to an area with endemic schistosomiasis.
* History of exposure to human therapeutic antibodies, immunoglobulins or other plasma products.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Markers of allergic inflammation in the nose measured over 5-8 days post-dose.
timeFrame: throughout the study
Secondary outcomes:
measure: - Nasal symptom scores over 5-8 days post-dose. - Blood levels of QAX576 to 3 months post-dose. - Marker of allergic inflammation in blood to 3 months post-dose.
timeFrame: throughout the study
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Novartis Investigator Site
city: London
country: United Kingdom
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis investigator site
name: NOVARTIS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01468584: Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Non-responder Genotype 2 Hepatitis C Infected Patients
Official title: A Phase 3 Study of MP-424 in Combination With Peginterferon Alfa-2b and Ribavirin, in Subjects With Genotype 2 Hepatitis C, Who Did Not Respond to Previous Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C
Keywords: Genotype 2
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2011-11-09
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and Ribavirin (RBV) in patients with genotype 2 hepatitis C, who did not respond to previous treatment.


Eligibility criteria: Inclusion Criteria:

* Genotype 2, chronic hepatitis C
* Non-responders (patient who did not respond to previous treatment)
* Able and willing to follow contraception requirements

Exclusion Criteria:

* Cirrhosis of the liver or hepatic failure
* Hepatitis B surface antigen-positive or HIV antibodies-positive
* History of, or concurrent hepatocellular carcinoma
* History of, or concurrent depression, schizophrenia,; or suicide attempt in the past
* Pregnant, lactating, or suspected pregnant patients, or male patients whose female partner is pregnant

Primary outcomes:
measure: Undetectable HCV RNA at 24 Weeks After Completion of Drug Administration (SVR, Sustained Viral Response)
timeFrame: After 24 weeks of follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Minato-ku
country: Japan
facility: Toranomon Hospital
state: Tokyo
Study officials:
affiliation: Mitsubishi Tanabe Pharma Corporation
name: Kazuoki Kondo, MD
role: STUDY_DIRECTOR
References:
citation: Kumada H, Sato K, Takehara T, Nakamuta M, Ishigami M, Chayama K, Toyota J, Suzuki F, Nakayasu Y, Ochi M, Yamada I, Okanoue T. Efficacy of telaprevir-based therapy for difficult-to-treat patients with genotype 2 chronic hepatitis C in Japan. Hepatol Res. 2015 Jul;45(7):745-54. doi: 10.1111/hepr.12416. Epub 2014 Nov 18.
Clinical trial NCT04123184: Oral Health Perception and Difficulties Encountered by Parents in the Implementation of Oral Hygiene of Children Under 6
Official title: Oral Health Perception and Difficulties Encountered by Parents in the Implementation of Oral Hygiene of Children Under 6, Qualitative Study.-
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carious Disease
Keywords: Therapeutic patient education
Having one child who as less than 6 years old
Pediatric Dentistry
Oral Health
Chronic Disease
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Parents or caregiver of the child, men or women, aged at least 18 years old, with a good understanding of the French language, accepting the terms of the study and not opposing its realization. The parent or caregiver with at least one child under the age of 6 who has a carious lesion or not.

Brief summary: A qualitative analysis was carried out on 15 participants, in 3 different places: the Montpellier health center, a pediatric odontology practice in Nîmes and a dentistry practice in Marseille.

Two methods of analysis were chosen: thematic analysis and word counting.


Eligibility criteria: Inclusion criteria:

Parent or caregiver with at least one child under 6 years of age, with Caod ≥ 1 and high RCI

Exclusion criteria:

* Patient refusing to participate in the study.
* Patient who does not understand the French language or who has difficulty expressing himself.

Primary outcomes:
measure: Evaluation of the image that parents have of oral health and carious disease
timeFrame: 1 day
Secondary outcomes:
measure: Evaluation of the motivations and brakes encountered by parents in the implementation of oral hygiene of their child
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Taormina Marion, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04051684: Regional TAP Block for Bariatric Patients
Official title: Transverse Abdominal Plane Blocks for Bariatric Surgery Patients: A Single Blinded Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Bariatric Surgery
Transverse Abdominal Plane Regional Blocks
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2019-08-09
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Addition of transverse abdominis plane (TAP) block to general anesthesia for morbidly obese patients (BMI \>35) undergoing laparoscopic bariatric surgery for weight loss will significantly reduce opioid use in the recovery room


Eligibility criteria: Inclusion Criteria:

1. The patient must be 18 years of age or older and able to provide his or her own consent.
2. The patient is scheduled for bariatric surgery including laparoscopic gastric banding, sleeve gastrectomy, and gastric bypass.
3. The patient must be surgically and medically accepted for the procedure
4. Good functional status, ability to perform activities of daily living
5. The patients BMI \> 35, no upper limit
6. Signed study specific informed consent prior to enrollment

Exclusion Criteria:

1. Patients with an allergy to local anesthetics
2. Patients diagnosed with peripheral neuropathies including diabetes mellitus.
3. Patients with BMI \<35
4. Patients with significant coronary artery disease
5. Patient refusal of block procedure.
6. Patients with chronic pain
7. Patients on pre-operative maintenance narcotics
8. American Society of Anesthesiologist classification system 4 (ASA 4) patients

Primary outcomes:
measure: Post Operative Opioid Usage
timeFrame: 24 hour after surgery
Secondary outcomes:
measure: Pain Score Assessed With Visual Analog Score (VAS)
timeFrame: 30 minutes within arrival to PACU
measure: Nausea: The Number of Participants Experiencing Nausea Will be Assessed by Chart Review
timeFrame: Up to 5 hours
measure: Vomiting: The Number of Participants Experiencing Vomiting Will be Assessed by Chart Review
timeFrame: Up to 5 hours
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Karina Gritsenko, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00488384: Acitretin Plasma Levels Under Hemodialysis
Official title: Acitretin Plasma Levels Under Hemodialysis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Carcinoma, Squamous Cell
Keywords: Squamous cell carcinoma of the skin under hemodialysis
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2007-06-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Acitretin is given to hemodialysis patients who have developed in-situ or invasive squamous cell carcinoma of the skin in increasing doses up to 25 mg daily for one year.

Detailed description: Acitretin is given to hemodialysis patients who have developed in-situ or invasive squamous cell carcinoma of the skin in increasing doses up to 25 mg daily for one year. Plasma levels of acitretin will be monitored and influence of hemodialysis on acitretin plasma levels will be determined. Number of in-situ or invasive squamous cell carcinoma of the skin cases will be determined.

* Trial with medicinal product

Eligibility criteria: Inclusion criteria:

* Hemodialyis patients with at least one case of in-situ or invasive squamous cell carcinoma of the skin

Exclusion criteria:

* Hepatopathy
* Pregnancy

Primary outcomes:
measure: Plasma levels acitretin
timeFrame: 2009
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Clinic for Dermatology University Hospital of Zurich
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT06234384: Foundation for Sarcoidosis Research Advanced Cures Registry (FSR-SARC Registry)
Official title: Foundation for Sarcoidosis Research Advanced Cures Registry (FSR-SARC Registry)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sarcoidosis
Lead sponsor: Foundation for Sarcoidosis Research
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 6647
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any adult or child (with a parent or legal guardian's assent) who has been given the diagnosis of sarcoidosis (including juvenile sarcoidosis or Blau Syndrome), and who are able to understand the consent form explaining the risks and benefits of participation.

Brief summary: The goal of the study is to create a longitudinal study of patient reported outcomes for people living with sarcoidosis that maintains privacy. Patients report on the following: demographics, disease symptoms, diagnostic journey, provider experience, disease treatment, and burden of disease. The goal is to create a natural history of sarcoidosis, support research, and better understand the needs of the sarcoidosis community.

Detailed description: Participants review a document, Understanding Your Participation, and check boxes on the Participant Informed Consent document that confirms they understand the risks/benefits of participation (or Assent if the patient is a minor age 7-18), they create an online account, and then are asked to complete the baseline survey questionnaire. Participants confirm they understand that their participation is completely voluntary, that their identifying information will be secured and encrypted, their private health information will be stored separately in a secure database. Their private information will never be shared with other people, unless its required by law. The registry may share de-identified information with researchers and other databases. Their personal information will be protected and not shared. They may choose to stop their participation at any time by contacting FSR. They are not required to fill out all the questions and can leave any unanswered. They will be contacted by the registry once a year to update or correct their health information. They can choose to be contacted by FSR if a study becomes available that they may wish to know more about.

Eligibility criteria: Inclusion Criteria:

1. English speaking
2. Consent
3. Sarcoidosi diagnosis -

Exclusion Criteria:

NONE

Primary outcomes:
measure: Completed participation in baseline survey
timeFrame: If a survey question is completely blank, a query can be sent to request the subject to complete the section. Subjects will be contacted only twice to attempt to resolve an issue. The timeframe from time to event outcome shall not exceed 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Foundation For Sarcoidosis Research
state: Illinois
Study officials:
References: