louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00111683: MK0457 in Patients With Leukemia (0457-003)
Official title: A Phase I/II Dose Escalation Study of MK0457 in Patients With Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Myelogenous Leukemia in Blast Crisis
Lymphocytic Leukemia, B Cell, Acute
Myelodysplastic Syndromes
Myelogenous Leukemia, Chronic
Keywords: Myelodysplastic Syndrome[Refractory Anemia with
Excess Blasts-1 or 2 (WHO Classification)]
Chronic Myelogenous Leukemia in blast crisis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-05-25
Enrollment: 28
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: In this study participants with relapsed/refractory leukemia will be given MK-0457 in sequential cohorts and with varying treatment duration to determine the maximum tolerated dose (MTD) for MK-0457.


Eligibility criteria: Inclusion Criteria:

Part 1:

* Patients with relapsed/refractory acute myelogenous leukemia (AML), poor risk myelodysplastic syndrome (MDS), B-cell acute lymphocytic leukemia (ALL), myeloproliferative diseases, or chronic myelogenous leukemia (CML) in blast crisis

Part 2:

* Acute myelogenous leukemia (with FLT-3 mutation ), and myeloproliferative diseases only
* At least 2 weeks since the last cytotoxic therapy
* Acceptable renal and hepatic function
* Ambulatory, capable of all self-care, and out of bed for more than 50% of waking hours
* More than 2 months since autologous bone marrow or peripheral blood stem cell transplantation

Exclusion Criteria:

* Not fully recovered from previous anti-leukemia therapy
* Previous allogeneic bone marrow transplant
* Uncontrolled congestive heart failure
* Myocardial infarction within the last 3 months
* Active or uncontrolled infection
* Pregnancy or lactation
* Currently active second malignancy, other than non-melanoma skin cancer
* History of hepatitis B or C, known HIV positivity, or AIDS related illness

Primary outcomes:
measure: Number of Participants Experiencing Dose-Limiting Toxicities (DLTs)
timeFrame: Part 1: up to 5 days, Part 2: up to 24 hours
Secondary outcomes:
measure: Hematological response rate to MK-0457 as a 5-day CIV infusion
timeFrame: At the end of each cycle (up to 18 months)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Giles FJ, Swords RT, Nagler A, Hochhaus A, Ottmann OG, Rizzieri DA, Talpaz M, Clark J, Watson P, Xiao A, Zhao B, Bergstrom D, Le Coutre PD, Freedman SJ, Cortes JE. MK-0457, an Aurora kinase and BCR-ABL inhibitor, is active in patients with BCR-ABL T315I leukemia. Leukemia. 2013 Jan;27(1):113-7. doi: 10.1038/leu.2012.186. Epub 2012 Jul 9.
Clinical trial NCT02796183: The Efficacy of Subconjunctival Bevacizumab in Diabetic Macular Edema
Official title: The Efficacy of Subconjunctival Bevacizumab in Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Macular Edema
Lead sponsor: Neon Hospital
Sponsor class: OTHER
Collaborators: name: Ondokuz Mayıs University
First posted: 2016-06-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study evaluates the effects of subconjunctivally injected bevacizumab in patients with diffuse diabetic macular edema.

Detailed description: At baseline, the macular thicknesses of both eyes of the patients with persistant diabetic macular edema were measured by optical coherence tomography. After 3.75mg bevacizumab was injected into subconjunctival space of the eyes with diabetic macular edema. The measurements of the macular thicknesses were repeated by optical coherence tomography in 15th, 30th, 60th day after injections. The macular thickness measurements before and after injection were compared.

Eligibility criteria: Inclusion Criteria:

* Having diffuse diabetic macular edema persisted at least 1 month
* No intravitreal injection in last 3 months.
* No retinal laser photocoagulation in last 6 months
* Not have any other macular disease causing macular edema

Exclusion Criteria:

* Having ischemic macula
* Intravitreal injection in last 3 months.
* Retinal laser photocoagulation in last 6 months
* Have any other macular disease causing macular edema

Primary outcomes:
measure: Central Macular Thickness
timeFrame: one year (between May 2015 and May 2016)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03607383: Red Rice Yeast in Low-density Lipoprotein (LDL) Lowering: an Efficacy Study
Official title: Red Rice Yeast in Low-density Lipoprotein (LDL) Lowering: an Efficacy Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Dyslipidemias
LDL Hyperlipoproteinemia
Keywords: statins
red rice yeast
adverse effects
cholesterol, LDL
treatment outcome
tolerability
Lead sponsor: Saint-Joseph University
Sponsor class: OTHER
First posted: 2018-07-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Red yeast rice is a source of active compounds in reducing LDL levels with practically no side effects. Molval Fort is a natural product available in the Lebanese market with a combination of red yeast rice extracts, EPA/DHA and coenzyme Q10.

The investigators are conducting this study to explore the effect of red yest rice extracts based product on LDL and its side effects in a sample of primary care Lebanese patients.

Detailed description: Red yeast rice is a source of active compounds in reducing LDL levels with practically no side effects. Studies performed on American and Chinese populations have shown positive results. These studies need confirmation in different populations. Molval Fort is a natural product available in the Lebanese market with a combination of red yeast rice extracts, EPA/DHA and coenzyme Q10. The investigators are conducting this study to explore the effect of red yest rice extracts based product on LDL and its side effects in a sample of primary care Lebanese patients.

Eligibility criteria: Inclusion Criteria:

* Adult patient (\>18 years)
* Indication to mild or moderate statin based on AHA 2013 guidelines
* Treatment naïve

Exclusion Criteria:

* Allergy to rice
* Renal or hepatic terminal disease
* Any contra indication to statin treatment
* Pregnancy wish during study period
* Familial hypercholesterolemia

Primary outcomes:
measure: LDL reduction
timeFrame: eight weeks
Secondary outcomes:
measure: incidence of side effects
timeFrame: eight weeks
Other outcomes:
measure: physician and patient satisfaction
timeFrame: eight weeks
Locations:
city: Jdeide
country: Lebanon
facility: Saint Anthony Primary Care Center
Study officials:
affiliation: Hôtel Dieu de France Hospital
name: Marouan Zoghbi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00829283: Treatment of Obesity and Binge Eating: Behavioral Weight Loss Versus Stepped Care
Official title: Treatment of Obesity and Binge Eating: Behavioral Weight Loss Versus Stepped Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Binge Eating
Keywords: Experimental
Comparator
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2009-01-27
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: This controlled study will test the effectiveness of a stepped-care approach to a standard behavioral weight loss treatment for obese patients with Binge Eating Disorder (BED). The major question is whether the stepped-care approach, which begins with behavioral weight loss and then follows a decision tree for additional interventions based on early treatment response is superior to standard behavioral treatment.

Detailed description: The stepped-care arm of this study included an obesity medication intervention. At the start of the study, the active medication was sibutramine and was compared to a placebo control. On 10/8/2010, Abbott Laboratories withdrew their obesity drug sibutramine (Meridia) from the market in light of clinical trial data pointing to an increased risk for stroke and myocardial infarction. In response to this event, the investigators submitted an IRB amendment to change the active obesity medication from sibutramine to Orlistat. The IRB amendment was approved on 11/4/2010. The PI received approval from NIH/NIDDK Program Officer Robert Kuczmarski to enact this change.

Eligibility criteria: Inclusion criteria:

* Obese (BMI\>=30)

Exclusion criteria:

* Medication regimen that represents medical contraindication to sibutramine
* Serious unstable or uncontrolled medical conditions that represent contraindication to sibutramine
* Pregnancy

Primary outcomes:
measure: Number of Subjects Who Reached Binge Eating Remission
timeFrame: 12 months follow-up
Secondary outcomes:
measure: BMI
timeFrame: 12 months follow-up post-treatment
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Carlos M Grilo, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grilo CM, White MA, Ivezaj V, Gueorguieva R. Randomized Controlled Trial of Behavioral Weight Loss and Stepped Care for Binge-Eating Disorder: 12-Month Follow-up. Obesity (Silver Spring). 2020 Nov;28(11):2116-2124. doi: 10.1002/oby.22975. Epub 2020 Sep 27.
Clinical trial NCT00666783: An Efficacy and Safety Study of Palonosetron in Preventing Chemotherapy-Induced Nausea and Vomiting (CINV) in the Chinese Cancer Patients
Official title: A Phase II, Multicenter,Double-Blind, Randomized Trial of Palonosetron Compared With Granisetron in Preventing Highly Emetogenic Chemotherapy-Induced Nausea and Vomiting in the Chinese Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chemotherapy-Induced Nausea and Vomiting
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2008-04-25
Enrollment: 208
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This clinical study was designed to demonstrate that a single, intravenous dose of palonosetron 0.25 mg was not inferior to granisetron 3 mg in preventing acute and delayed CINV and was also well tolerated in the Chinese cancer patients.


Eligibility criteria: Inclusion Criteria:

* Male or female, age ranging from 18 yrs to 70 yrs, with histologically or cytologically confirmed malignant disease
* naive to chemotherapy or nonnaive with an interval of at least 14 days to the last one
* Karnofsky index more than 70% and anticipated survival time more than 90 days
* Scheduled to receive any of the following cytotoxic agents based combination chemotherapy (epirubicin 60 mg/m2, or cisplatin 75 mg/m2) on study Day 1 and the chemotherapy should be accomplished on study Day 1
* No emetic episodes and antiemetic medication during the 24 hours preceding chemotherapy administration
* Adequate organ functions(No impairment to renal, hepatic, cardiac or bone marrow function )
* Use of reliable contraceptive measures (for females of childbearing potential) and negative pregnancy test at baseline visit
* Provision of written informed consent

Exclusion Criteria:

* Inability to understand or cooperate with study procedures
* Receipt of investigational drugs 30 days before study entry
* Scheduled to receive any drug with antiemetic efficacy from 24 hrs before to 5 days after treatment
* Contraindications to 5-HT3 receptor antagonists
* Woman Patient with Pregnancy or lactation
* Diagnosed with hypertension or severe infectious diseases
* Obstructive symptom of gastrointestinal tract
* Symptomatic brain metastasis or mental dysfunction
* Baseline QTc \> 500 ms

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Xi,an
country: China
facility: Xijng Hospital
state: Shaanxi
Study officials:
References:
Clinical trial NCT05134883: PNF Stretching Compared to SMR on Hamstrings
Official title: Effects of Hamstrings Flexibility After Proprioceptive Neuromuscular Facilitation Stretching Compared to Self-myofascial Release: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sports Physical Therapy
Keywords: Stretching
Propioceptive neuromuscular facilitation
Hamstrings
Lead sponsor: Universitat Internacional de Catalunya
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The use of stretching techniques in the sports world is frequent and widely used for its many effects. One of the main benefits is the gain in flexibility, range of motion and facilitation of the sporting performance. Recently the use of self-myofascial release (SMR) has spread in sports practice both at elite and recreational level for its benefits being similar to those observed in stretching. The objective of the following study is to compare the results of the proprioceptive neuromuscular facilitation stretching with SMR on the hamstring muscle flexibility.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* hypermobility
* hamstring injury in the previous 6 months
* diagnosed orthopedic problems
* surgery in the lower limbs
* back pain
* spine surgery
* systemic or neurological disorders.

Primary outcomes:
measure: Hamstring muscle flexibility (mm)
timeFrame: Change between baseline(immediately before intervention), mid-intervention (30 seconds after the start of the intervention) and post intervention (2 minutes after the start of the intervention)
Secondary outcomes:
measure: Discomfort sensation
timeFrame: Change between baseline(immediately before intervention), mid-intervention (30 seconds after start of intervention) and post intervention (2 minutes after the start of the intervention)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Universitat Internacional Catalunya
state: Sant Cugat
Study officials:
affiliation: Universitat International Catalunya
name: Albert Pérez-Bellmunt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00913783: To Demonstrate the Relative Bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fasted Conditions
Official title: Comparative, Randomized, 2-way Crossover Bioavailability Study of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules In Health Adult Males Under Fasted Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Depression
Keywords: Antidepressant
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2009-06-04
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To demonstrate the relative bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride capsules under fasted conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.

Primary outcomes:
measure: Bioequivalence based on AUC and Cmax
timeFrame: 34 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Phoenix International Life Science Inc.
name: Richard Lalonde, Pharm.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01405183: Association Between Hepatitis C Infection and Renal Cell Carcinoma
Official title: Association Between Hepatitis C Infection and Renal Cell Carcinoma, a Case Control Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Renal Cell Carcinoma
Colorectal Cancer
Keywords: Hepatitis C
Renal Cell Carcinoma
Colorectal Cancer
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Schering-Plough
First posted: 2011-07-29
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Renal cell carcinoma patients will be identified from the urology clinic and from the hospital wards.

Colorectal cancer patient will be identifed from the hospital wards, pathology reports and gastroenterology endoscopy suits.

Brief summary: The purpose of this study is to determine if there is an association between hepatitis C infection and kidney cancer. All patients who are diagnosed with kidney cancer and who will either have a biopsy or surgery will be offered to be tested for hepatitis C. The control group will be colon cancer patients. Both groups would be of recent diagnosis (6 months).


Eligibility criteria: Inclusion Criteria:

* Male and female patients 18 years or older in whom renal cell carcinoma is suspected and are scheduled for either biopsy or partial or total nephrectomy. Diagnosis within 6 months.
* Male and female patients 18 years or older in whom colorectal cancer has been diagnosed within the last 6 months

Exclusion Criteria:

* Patients who are unwilling to provide consent
* Patients who decline to complete a questionnaire
* Patient in who blood sample cannot be obtained
* Diagnosis of renal cell carcinoma or colon cancer greater than 6 months

Primary outcomes:
measure: Prevalence of hepatitis C in renal cell carcinoma patients
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
Study officials:
affiliation: Henry Ford Hospital
name: Humberto C Gonzalez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Henry Ford Hospital
name: Stuart C Gordon, MD
role: STUDY_CHAIR
References:
citation: Gordon SC, Moonka D, Brown KA, Rogers C, Huang MA, Bhatt N, Lamerato L. Risk for renal cell carcinoma in chronic hepatitis C infection. Cancer Epidemiol Biomarkers Prev. 2010 Apr;19(4):1066-73. doi: 10.1158/1055-9965.EPI-09-1275. Epub 2010 Mar 23.
Clinical trial NCT05108883: Risk Stratification Using Midregional Proadrenomedullin in the ED
Official title: IDEntifying pAtients With Suspicion of Infection in the ED Who Have Low Disease Severity Using Midregional Proadrenomedullin (MR-proADM) - Pivotal Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients Presenting With Suspicion of Infection to the ED
Lead sponsor: Brahms AG
Sponsor class: INDUSTRY
First posted: 2021-11-05
Enrollment: 463
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Emergency departments (ED) are becoming increasingly over-crowded, with patients facing prolonged waiting times. Therefore, a safe and rapid assessment that identifies patients with low severity that could be treated as outpatients is essential for improving the workflow within the ED.

The rationale of this IDEAL+ study is to safely decrease the number of hospital admissions through identification of low risk patients with the biomarker MR-proADM. This will has already been tested in the IDEAL - pilot study and results should be confirmed with this IDEAL+ study.


Eligibility criteria: Inclusion Criteria:

1. Consecutive patients presenting to the ED with suspicion of infection
2. Age ≥18 years
3. Written Informed Consent obtained

Exclusion Criteria:

1. Patients with SARS-COV-2 infection
2. Recent major trauma or surgery
3. End stage renal failure requiring dialysis
4. Terminal disease and/or very severe medical co-morbidity where death has to be expected in the next 6 months, e.g. due to malignancy, cardiac, renal or hepatic failure
5. Patients whose source of infection always requires hospital admission or never requires hospital admission.
6. Patients who cannot be discharged for other than medical reasons
7. Patient participates in any other interventional clinical trial
8. Patients with active abusive drug use
9. Pregnant or lactating women
10. Patients who are institutionalized by official or judicial order
11. Dependents of the sponsor, the CRO, the study site or the investigator

Primary outcomes:
measure: Number of out-patients re-presenting to the ED
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière, AP-HP.Sorbonne Université
city: Roma
country: Italy
facility: Policlinico Tor Vergata
city: Udine
country: Italy
facility: Hospital Santa Maria della Misericordia
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias (HUCA)
state: Asturias
city: Barcelona
country: Spain
facility: Hospital Clinic
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Seville
country: Spain
facility: Hospital Virgen de la Macarena
city: Basingstoke
country: United Kingdom
facility: Hampshire Hospitals NHS Foundation Trust
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS Foundation Trust
Study officials:
References: