louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01767766: Evaluate the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies
Official title: A Phase I Dose Escalation Study Evaluating the Safety and Efficacy of TGR 1202 in Patients With Relapsed or Refractory Hematologic Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Hodgkin's Lymphoma
Chronic Lymphocytic Leukemia
Peripheral T-Cell Lymphoma
Hodgkin's Lymphoma
Lead sponsor: TG Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: SCRI Development Innovations, LLC
First posted: 2013-01-14
Enrollment: 90
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: The purpose of this study is to evaluate the safety and effectiveness of TGR-1202 in patients with advanced hematologic malignancies.


Eligibility criteria: Inclusion Criteria:

* Refractory to or relapsed after at least 1 prior treatment regimen;
* Eastern Cooperative Oncology Group (ECOG) score of 0 to 2;
* At least 18 years of age.

Exclusion Criteria:

* Any major surgery, chemotherapy or immunotherapy within the last 21 days (limited palliative radiation is allowed ≥ 2 weeks);
* Autologous hematologic stem cell transplant within 3 months of study entry or Allogeneic hematologic stem cell transplant within 12 months;
* Known hepatitis B virus, hepatitis C virus or HIV infection;
* Previous therapy with GS-1101 (CAL-101), IPI-145 or any drug that specifically inhibits the PI3K or mTOR pathway;

Primary outcomes:
measure: Maximum Tolerated Dose acceptable for participants
timeFrame: 28 days (1 cycle of therapy)
Secondary outcomes:
measure: Overall Response Rate
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Sarasota
country: United States
facility: TG Therapeutics Trial Site
state: Florida
city: Hackensack
country: United States
facility: TG Therapeutics Trial Site
state: New Jersey
city: New York
country: United States
facility: TG Therapeutics Trial Site
state: New York
city: Durham
country: United States
facility: TG Therapeutics Trial Site
state: North Carolina
city: Cincinnati
country: United States
facility: TG Therapeutics Trial Site
state: Ohio
city: Nashville
country: United States
facility: TG Therapeutics Trial Site
state: Tennessee
city: Milwaukee
country: United States
facility: TG Therapeutics Investigational Trial Site
state: Wisconsin
Study officials:
affiliation: SCRI Development Innovations, LLC
name: Howard Burris, MD, FACP
role: STUDY_CHAIR
References:
citation: Burris HA 3rd, Flinn IW, Patel MR, Fenske TS, Deng C, Brander DM, Gutierrez M, Essell JH, Kuhn JG, Miskin HP, Sportelli P, Weiss MS, Vakkalanka S, Savona MR, O'Connor OA. Umbralisib, a novel PI3Kdelta and casein kinase-1epsilon inhibitor, in relapsed or refractory chronic lymphocytic leukaemia and lymphoma: an open-label, phase 1, dose-escalation, first-in-human study. Lancet Oncol. 2018 Apr;19(4):486-496. doi: 10.1016/S1470-2045(18)30082-2. Epub 2018 Feb 20.
Clinical trial NCT02253966: Preoperative Intraarticular Injection of Methylprednisolone in Patients Scheduled for Total Knee-arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Knee Joint Osteoarthrosis
Hyperalgesia
Severe Movement Related Pain
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Lundbeck Foundation
First posted: 2014-10-01
Enrollment: 48
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Despite improvements in analgesic treatment following total knee arthroplasty (TKA) for osteoarthrosis, a substantial part of patients still have severe acute pain after surgery. It has been suggested that preoperative degree of intraarticular inflammation is associated to postoperative degree of pain and level of function. Furthermore it is known, that patients with preoperative inflammation have hyperalgesia and severe movement related pain.

The aim of this study is to investigate the effect of a preoperative intraarticular injection of Methylprednisoloneacetate in reducing acute postoperative pain after total knee arthroplasty in patients with signs of severe pre-operative inflammation and pain.


Eligibility criteria: Inclusion Criteria:

* Age 50 -80
* Osteoarthrosis
* Scheduled for primary unilateral TKA
* Preoperative pain report with NRS \> 5 upon walking
* Signs of sensitisation in knee

Exclusion Criteria:

* Allergies to methylprednisoloneacetate, lidocaine or standard analgesic treatment
* Deficient written or spoken danish
* Impairment from psychological or neurological disease
* Local og systemic infection
* Immunodeficiency
* Treatment with corticosteroid within 30 days of inclusion
* Insulin treated diabetes mellitus
* Anticoagulant therapy
* ASA (American Society of Anaesthesia) class \> 3
* General anaesthesia
* Alchohol use \> 21 units / week
* Pregnancy

Primary outcomes:
measure: Pain
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Pain
timeFrame: 48 hours postoperatively
measure: Pain
timeFrame: From day 1 to day 14
measure: Pain
timeFrame: From day 1 to day 14
measure: Sensitisation
timeFrame: On day 0 and day 2
measure: Inflammation
timeFrame: On day 0 and day 2
measure: Inflammation
timeFrame: On day 0
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Gentofte Hospital
Study officials:
References:
Clinical trial NCT04855266: Iron Sucrose in Patients With Iron Deficiency and POTS
Official title: A Randomized, Controlled, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy of Intravenous Iron Sucrose in Patients With Non-anemic Iron Deficiency and Postural Orthostatic Tachycardia Syndrome (POTS)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Iron-deficiency
Postural Orthostatic Tachycardia Syndrome
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate whether the treatment of non-anemic iron deficiency with intravenous iron sucrose will result in decreased symptom reporting and improved cardiovascular indices in patients with Postural Orthostatic Tachycardia syndrome (POTS).


Eligibility criteria: Inclusion Criteria:

* Patients (age 12 to years and older) with chronic (\>3 months) symptoms of orthostatic intolerance, including but not limited to lightheadedness, syncope, headache, fatigue, weakness, sweating, nausea and heart palpitations.
* Symptomatic orthostatic heart rate increment ≥30 bpm if \>19 years old or ≥40 bpm if \<19 years old during a 10 minute 70 degree head up tilt study
* Presence of non-anemic iron deficiency, defined as serum ferritin levels \<20 ug/L with hemoglobin no less than 1 gm/dL below the normal reference range as defined for age and gender
* Consent obtained from responsible guardian AND from subjects, 12-17 years of age
* Consent obtained for subjects 18 years of age and older

Exclusion Criteria:

* Orthostatic hypotension (decrease of systolic BP\>30 mmHg and/or diastolic BP\>15mmHg within 3 minutes of 70 degree head up tilt study)
* Pregnant or lactating females
* The presence of failure of other organ systems or systemic illness that can affect autonomic function
* Concomitant therapy with anticholinergic, alpha-adrenergic antagonists, beta-adrenergic antagonists or other medications which could interfere with autonomic testing. Patients may participate if the potentially interfering medication is held for five half-lives prior to the study
* Laboratory evidence of anemia or iron overload
* Personal history of hematochromatosis or first degree relative with hematochromatosis
* Known sensitivity to Venofer® (iron sucrose injection, USP) or other intravenous iron preparation

Primary outcomes:
measure: Change in autonomic dysfunction symptoms
timeFrame: Baseline, 7 days, 6 months
measure: Change in postural heart rate increase
timeFrame: Baseline, 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Kamal Shouman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03625466: A Study to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del
Official title: An Exploratory Phase 2, 2-part, Randomized, Double-blind, Placebo-controlled Study With a Long-term, Open-label Period to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cystic Fibrosis
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2018-08-10
Enrollment: 51
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will explore the impact of lumacaftor/ivacaftor (LUM/IVA) on disease progression in subjects aged 2 through 5 years with cystic fibrosis (CF), homozygous for F508del (F/F).


Eligibility criteria: Key Inclusion Criteria:

* Subjects with confirmed diagnosis of CF.
* Homozygous for F508del (F/F).
* Subjects who weigh ≥8 kg without shoes and wearing light clothing at the Screening Visit.

Key Exclusion Criteria:

* Any clinically significant laboratory abnormalities at the Screening Visit that would interfere with the study assessments or pose an undue risk for the subject.
* Solid organ or hematological transplantation.
* History of any illness or comorbidity reviewed at the Screening Visit that, in the opinion of the investigator, might confound the results of the study.

Other protocol defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Part 1: Absolute Change From Baseline in MRI Global Chest Score at Week 48
timeFrame: From Baseline at Week 48
Secondary outcomes:
measure: Part 1: Absolute Change in Lung Clearance Index2.5 (LCI2.5) Through Week 48
timeFrame: From Baseline Through Week 48
measure: Part 1: Absolute Change in Weight-for-age Z-score at Week 48
timeFrame: From Baseline at Week 48
measure: Part 1: Absolute Change in Stature-for-age Z-score at Week 48
timeFrame: From Baseline at Week 48
measure: Part 1: Absolute Change in Body Mass Index (BMI)-For-age Z-score at Week 48
timeFrame: From Baseline at Week 48
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite Paediatric Pulmonology Department
city: Giessen
country: Germany
facility: Justus-Leibig-Universitat Zentrum fur Kinderheilkunde und Jugendmedizin
city: Hannover
country: Germany
facility: Hannover Medical School
city: Heidelberg
country: Germany
facility: Heidelberg Cystic Fibrosis Center
city: Lubeck
country: Germany
facility: Universitatsklinikum Schleswig-Holstein, Klinik für Kinder- und Jugendmedizin
Study officials:
References:
Clinical trial NCT03104166: Modulation of Vascular Calcification in Chronic Dialysis Patients
Official title: Modulation of Vascular Calcification in Chronic Dialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vascular Calcification
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 50
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: 50 patients will be randomized and treated with MCO or highflux dialysis for six months (24 weeks) after a run-in phase of 4 weeks Highflux treatment.

Serum samples will be drawn at baseline, after 4, 8 and 24 weeks.

Later, calcifiying vascular smooth muscle cells will be incubated with these serum samples and calcification will be assessed with Alkaline phosphatase and Alizarin staining.

Primary endpoint:

In vitro Calcification of coronary vascular smooth muscle cells (Alkaline Phosphatase/ WST8) after six months

Calcifiying vascular smooth muscle cells will be incubated with serum samples obtained after six months of MCO/HF dialysis and calcification will be assessed with Alkaline phosphatase and WST8.

Secondary Endpoints:

Aortic Pulse wave velocity after 6 months Calcification propensity after 6 months Physical activity level after 6 months

Cell culture: Incubation of VSMC with serum samples obtained after 6 months

* Alizarin staining/WST-8
* Measurement of calcification inhibitors Osteopontin and Matrix Gla Protein in Supernatants
* Apoptosis

The treatment regimen of the patients will not be altered, hence blood flow, dialysate flow as well as dialysis time will remain constant.


Eligibility criteria: Inclusion Criteria:

* Age 18 years an older
* Chronic dialysis patients for at least 3 months

Exclusion Criteria:

* Serum albumin \<32g/L at the last routine albumin measurement
* Pregnancy

Primary outcomes:
measure: In vitro Calcification of coronary vascular smooth muscle cells (Alkaline Phosphatase/ WST8) after six months
timeFrame: Six months
Secondary outcomes:
measure: Aortic Pulse wave velocity
timeFrame: Six months
measure: Calcification propensity
timeFrame: Six months
measure: Physical activity level
timeFrame: Six months
measure: Cell culture: Incubation of VSMC with serum samples and assessment of • Alizarin staining/WST-8 • Measurement of calcification inhibitors Osteopontin and Matrix Gla Protein in Supernatants • Apoptosis
timeFrame: Six months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Virchow
Study officials:
References:
Clinical trial NCT04115566: Hidradenitis Suppurativa Prospective Observational Registry and Biospecimen Repository
Official title: Hidradenitis Suppurativa Prospective Observational Registry and Biospecimen Repository
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hidradenitis Suppurativa
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2019-10-04
Enrollment: 3000
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HS Patients

Brief summary: Hidradenitis suppurativa (HS) is a common and debilitating skin disease that is poorly understood and understudied. As a result, little is known about disease prognosis and few effective treatments exist for this condition. This prospective observational cohort study aims to comprehensively characterize the clinical and biological features of HS. The results of this research will provide a basis for the development of an HS clinical classification system and identification of potential treatments for HS.


Eligibility criteria: Inclusion Criteria:

1. Male or female ≥ 10 years of age
2. Diagnosis of HS by a dermatologist or practitioner experienced in making a diagnosis of HS
3. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.

Exclusion Criteria:

1. Inability to give informed consent or unavailability of a parent/guardian who is able and willing to give informed consent.

Primary outcomes:
measure: Primary Objective
timeFrame: 2019-2029
Secondary outcomes:
measure: Secondary Objective
timeFrame: 2019-2029
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Haley B Naik, MD, MHSc, FAAD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04772066: Tools to Assess Medication Adherence
Official title: Evaluation of Tools to Assess Medication Adherence
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Medication Adherence
Keywords: Medication Adherence
Clinical Pharmacist
Self-reported scale
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-02-26
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study population was composed of patients admitted in Montpellier University Hospital.

Brief summary: The issue of medication adherence (MA) has long been undestimated but is now growing interest due to both the increase of patients with chronic diseases and the aging of the population. According to the World Health Organization, only 50% of patients with chronic illnesses correctly follow physician's prescriptions in developed countries. Beyond the individual consequences that failure to adherence can engender (increased morbidity, mortality and hospitalizations), this concept also encompasses a collective dimension (risk of transmission of infectious diseases and increased health care costs). Today, improving MA would have more impact on human health than developping new medical therapies. That's why detecting non-adherence constitutes a major public health issue in which pharmacists play a significant role through medication reconciliation and patients' education.

The methods wildly used are based on indirect measurement: questionnaires completed by the patient himself or the Medication Possession Ratio (MPR). Each method has its own advantages and disadvantages, but none is considered as the gold standard. The Montpellier University Hospital set up a MA self-report scale ranging from 0 (low) to 10 (high adherence) in the various care units where the clinical pharmacy activity is deployed.

The purpose of this study was to assess the MA according to this numerical scale and the MPR calculation, and evaluate the correlation between these two methods.


Eligibility criteria: Inclusion criteria:

- Subjects aged over 18 years old, admitted in a care unit of Montpellier University Hospital where the clinical pharmacy activity is deployed

Exclusion criteria:

- Subjects without any medication therapy at home

Primary outcomes:
measure: Self-reported MA according to self-reported medication adherence scale
timeFrame: 1 day
measure: MA according to Medication Possession Ratio (MPR) calculation
timeFrame: 1 day
Secondary outcomes:
measure: Number of patients with medication non-adherence according to self-reported MA scale and MPR calculation
timeFrame: 1 day
measure: Variables associated with medication non-adherence
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Cyril BREUKER, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04348266: RFA for GIM Treatment
Official title: Efficacy of Radiofrequency Ablation in Treatment of Gastric Intestinal Metaplasia: a Randomized, Self-control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastric Intestinal Metaplasia
Treatment
Radio-frequency Ablation
Lead sponsor: King Chulalongkorn Memorial Hospital
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study in only GIM patients but will divide the stomach into 2 sites (left and right) to random for RFA treatment.
Primary purpose: TREATMENT

Brief summary: Use radiofrequency ablation (RFA) for Gastric intestinal metaplasia (GIM) treatment.

Detailed description: Gastric intestinal metaplasia (GIM) is a pre-malignant lesion. Currently, there is no standard treatment for this condition, thus the patients with GIM need surveillance endoscopy every 1-3 years, regarding to the severity and extension of lesion. However, the protocol for GIM surveillance is uncertain and need high cost.

Radiofrequency ablation (RFA) is used for Barrett's esophagus (BE; pre-malignant lesion of esophageal adenoCA) treatment as a standard treatment. The investigators hypothesized that RFA may effective in GIM treatment.

The investigators will random GIM participants to have the RFA treatment only one site of the stomach (left or right). At the first session, the investigators will biopsy at suspected GIM lesions to confirm the diagnosis and severity of GIM. Two months later, The investigators will apply RFA to all GIM lesions at the assigned location and then every 2 months for 3 sessions or until no GIM lesion seen by endoscopy. The final endoscopy will be done at 1 year follow-up and biopsy will be performed to assess the efficacy of RFA compare to no treatment.

Eligibility criteria: Inclusion Criteria:

* More than 18 years of age
* Previous diagnose of extensive or incomplete GIM

Exclusion Criteria:

* No GIM at first endoscopy
* Previous gastric surgery
* Coagulopathy
* Pregnancy or lactation
* Unable to perform appropriate peri-procedural cessation of antiplatelet/antithrombotic therapy
* Unable to sign the consent

Primary outcomes:
measure: Number of GIM lesions regression
timeFrame: 1 year
Secondary outcomes:
measure: Number of GIM regression by location
timeFrame: 1 year
Other outcomes:
Locations:
city: Pathum Wan
country: Thailand
facility: Rapat Pittayanon
state: Bangkok
Study officials:
References:
Clinical trial NCT01087866: Metformin Versus Insulin in the Treatment of Gestational Diabetes Mellitus
Official title: Metformin Versus Insulin in the Treatment of Gestational Diabetes Mellitus: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Gestational Diabetes Mellitus
Keywords: Gestational diabetes mellitus
treatment
metformin
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2010-03-16
Enrollment: 97
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if metformin therapy prevents fetal macrosomy in gestational diabetes mellitus to the same extent as insulin therapy.


Eligibility criteria: Inclusion Criteria:

* gestational diabetes mellitus diagnosed between 12-34 pregnancy weeks if normoglycemia is not reached with diet

Exclusion Criteria:

* hypertension with pharmacological treatment or preeclampsia
* multiple pregnancy
* liver or kidney disease

Primary outcomes:
measure: Percentage of fetal macrosomy
Secondary outcomes:
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: Oulu University Hospital
name: Hilkka Ijas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oulu University Hospital
name: Tytti Raudaskoski, MD,PhD
role: STUDY_DIRECTOR
affiliation: Oulu University Hospital
name: Marja Vaarasmaki, MD, PhD
role: STUDY_CHAIR
References:
citation: Ijas H, Vaarasmaki M, Morin-Papunen L, Keravuo R, Ebeling T, Saarela T, Raudaskoski T. Metformin should be considered in the treatment of gestational diabetes: a prospective randomised study. BJOG. 2011 Jun;118(7):880-5. doi: 10.1111/j.1471-0528.2010.02763.x. Epub 2010 Nov 18.