louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00193102: Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer
Official title: Phase II Study of Thalidomide in Combination With Capecitabine in Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Celgene Corporation
First posted: 2005-09-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The lack of non-overlapping toxicities between the two drugs, the ease of all oral drug administration, and the possibility for antitumor synergy make exploration of this combination regimen attractive in women with previously treated metastatic breast cancer. This phase II trial will be performed in collaboration with the Minnie Pearl Cancer Research Network, a multicenter, community-based clinical trials group.

Detailed description: Upon determination of eligibility, patients will be receive:

Thalidomide + Capecitebine

Eligibility criteria: Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Metastatic breast cancer confirmed by biopsy
* Measurable or evaluable disease
* Females \> 18 years
* Able to perform activities of daily living with minimal assistance
* Life expectancy \> 3 months
* Adequate bone marrow, liver and kidney function
* All patients must give written informed consent in order to participate.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Women who are pregnant or lactating.
* Received more than 3 prior chemotherapy regimens in the metastatic setting.
* Received continuous infusion 5-fluorouracil lasting \> 120 hours.
* Received thalidomide or capecitabine as their last prior regimen.
* Preexisting moderate to severe neuropathy

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Primary outcomes:
measure: Overall response rate
timeFrame: 18 Months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: SCRI Development Innovations, LLC
name: Howard Burris, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Burris HA 3rd, Jones SF, Shipley D, Meluch AA, Greco FA, Barton JH, Yardley DA, Hainsworth JD. Phase II study of capecitabine in combination with thalidomide in patients with metastatic breast cancer. Cancer Invest. 2010 May;28(4):408-12. doi: 10.3109/07357901003631049.
Clinical trial NCT02949102: Crave Crush Neuroimaging Study
Official title: Effects of Gymnemic Acids Lozenge on Reward Region Response to Receipt and Anticipated Receipt of High-Sugar Food, High-Sugar Food Pictures, and Ad Lib Candy Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: Oregon Research Behavioral Intervention Strategies, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Cravecrush
name: Oregon Behavioral Intervention Strategies, Inc.
First posted: 2016-10-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the research is to test whether a gymnemic acids (GA) lozenge will reduce reward region response to intake of high-sugar food and ad lib candy intake and whether the GA lozenge reduced reward region response to anticipated intake of high-sugar food and high-sugar food pictures relative to a placebo lozenge.

Detailed description: Test the hypothesis that an acute dose of Crave Crush will produce greater reductions in reward region response to a taste of a high-sugar/high-fat beverage and anticipated receipt of this beverage than a placebo dose.

Test the hypothesis that a dose of Crave Crush will result in reduced ad lib candy intake while the participants complete a survey after the fMRI scan. Participants will receive a second dose of Crave Crush or placebo. They will then be placed in a room to complete a few surveys. A bowl of candy will be placed on the table. Participants will be told that the candy is left over from their assessment and that they are free to have as much as they like, because the candy must be discarded after each participant.

Eligibility criteria: Inclusion Criteria:

* Between 18 and 50 years old
* report having a sweet tooth
* report desire to lose weight
* Body Mass Index between 18 and 40

Exclusion Criteria:

* major psychiatric disorders
* serious health problems (e.g., diabetes)
* habitual use of psychoactive drugs or medications
* contraindications for MRI scanning (e.g., ferromagnetic braces)
* gluten or lactose intolerance
* a vegan diet.

Primary outcomes:
measure: fMRI responses to high-sugar food tastes and food cues
timeFrame: 13 minutes
Secondary outcomes:
measure: candy consumption
timeFrame: 15 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Oregon Research Behavioral Intervention Strategies
name: Eric Stice, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03729102: Immunological Tolerance After Frequent Rabies Booster Vaccinations
Official title: Immunological Tolerance After Frequent Rabies Booster Vaccinations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rabies
Keywords: rabies vaccination
Lead sponsor: Queen Saovabha Memorial Institute
Sponsor class: OTHER
First posted: 2018-11-02
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There would be two study groups. Those who had received primary immunization would be the control group. While persons who had received primary immunization and later received booster vaccination for at least 3 times would be the study group.

All participants would be given one dose of rabies vaccine and monitored the immunological cells and cytokines before and after the rabies booster injection.
Primary purpose: TREATMENT

Brief summary: To study immunological tolerance effect after frequent rabies booster vaccination

Detailed description: Previous studies had shown lower antibody titers among those who received frequent rabies booster vaccination, compared to ones who had got primary immunization. We study immunological cells i.e., regulatory T cell, regulatory B cell, T follicular helper cell, and cytokines in those who received frequent rabies booster vaccination.

Eligibility criteria: Inclusion Criteria:

* Healthy adults
* Previously received rabies vaccination

Exclusion Criteria:

* Had immunocompromised conditions
* Received blood or blood product within 3 months
* Received anti-malarial drugs

Primary outcomes:
measure: Rabies specific regulatory T cells
timeFrame: Change from baseline of numbers of Rabies specific regulatory T cells before (baseline) and one month after receipt of rabies booster vaccination were compared between 2 arms
measure: Rabies specific regulatory B cells
timeFrame: Change from baseline of numbers of Rabies specific regulatory B cells before (baseline) and one month after receipt of rabies booster vaccination were compared between 2 arms
measure: Rabies specific T follicular helper cells
timeFrame: Change from baseline of numbers of Rabies specific T follicular helper cells before (baseline) and one month after receipt of rabies booster vaccination were compared between 2 arms
Secondary outcomes:
measure: Rabies Neutralizing Antibody Titers (RNab)
timeFrame: before (baseline) and one month after receipt of rabies booster vaccination
Other outcomes:
measure: Cytokines
timeFrame: Change from baseline of quantitative measurement of cytokines levels would be measured before (baseline) and one month after receipt of rabies booster vaccination and compared between 2 arms
Locations:
city: Pathum Wan
country: Thailand
facility: Queen Saovabha Memorial Institute
state: Bangkok
Study officials:
affiliation: Queen Saovabha Memorial Institute
name: Suda Sibunruang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00609102: Antioxidant Treatment of Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Type 2 Diabetes
Keywords: Type 2 diabetes
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Sponsor class: NIH
First posted: 2008-02-06
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study examines whether an antioxidant taken orally will improve glucose tolerance and insulin secretion in type 2 diabetic subjects.


Eligibility criteria: Inclusion Criteria: Subjects with a known diagnosis of type 2 diabetes -

Exclusion Criteria: None, except known intolerance to n-acetylcysteine

-

Primary outcomes:
measure: Blood glucose
timeFrame: 3 months
Secondary outcomes:
measure: HbA1c levels
timeFrame: 3 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Pacific Northwest Research Institute
state: Washington
Study officials:
References:
Clinical trial NCT04800302: U/S-guided Continuous Quadratus Lumborum Block III in Percutaneous Nephrolithotomy
Official title: Ultrasound-guided Continuous Quadratus Lumborum Block III for Postoperative Analgesia in Percutaneous Nephrolithotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Surgery
Renal Stone
Keywords: Quadratus Lumborum Block III
Ultrasound-guided
Percutaneous nephrolithotomy
Analgesia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-03-16
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Percutaneous nephrolithotomy (PCNL) is considered to be the first choice and a more conservative procedure than open stone surgery. Not only postoperative pain related to dilatation of the renal capsule and parenchymal tract, but also patient's discomfort \& nephrostomy tube-related stress are reported to delay recovery time and increase the complication rates. This study is designed to provide postoperative analgesia by using ultrasound-guided continuous Quadratus Lumborum Block (QLB) III in patients undergoing PCNL and to assess pain scores \& side effects with less opioids consumption.


Eligibility criteria: Inclusion Criteria:

* ASA I-II.
* Scheduled for percutaneous nephrolithotomy (PCNL).

Exclusion Criteria:

* Patient refusal.
* Coagulation disorders.
* Skin lesions or infection at site of needle insertion.
* Known allergy to local anesthetics or opioids.
* Patients suffering from neurological or mental disease.
* Procedure turned into open stone surgery.
* Failure of identification by U/S.
* Urinary tract malignancies.
* Opioid consumption 48 hours before the operation.

Primary outcomes:
measure: Morphine consumption.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospitals
Study officials:
affiliation: Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University
name: Sherif A Embaby, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00169702: The Effect of a Weight Management Program During Treatment With Olanzapine
Official title: The Effect of a Weight Management Program to Prevent Weight Gain and Metabolic Abnormalities During Treatment With the Atypical Neuroleptic Olanzapine: A Randomised Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Schizophrenia, weight management programme
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
name: Else Kröner-Fresenius-Centre for Nutritional Medicine
name: Technical University of Munich
First posted: 2005-09-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study is a prospective, randomized, open-label study.

Detailed description: The principal objective of this trial is to investigate the effect of a comprehensive behavioural treatment program on weight gain in schizophrenic patients under olanzapine treatment, and on subjective well-being.

Eligibility criteria: Inclusion Criteria:

* Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for schizophrenia
* Ages between 18 and 65
* Informed consent
* Weight gain of at least 1.5 kg in the first 4 weeks
* A sufficient understanding to participate adequately in the weight management program
* Patients must agree to cooperate with all tests and examinations required by the protocol.
* Each patient must understand the nature of the study and must sign an informed consent document.

Exclusion Criteria:

* Serious, unstable somatic illnesses
* Illnesses associated with weight gain including renal and endocrine diseases
* Weight change greater than 3 kg in the preceding three months
* Weight gain less than 1.5 kg in the first 4 weeks

Primary outcomes:
measure: difference in mean weight gain
timeFrame: November 2007
Secondary outcomes:
measure: changes in waist circumference, blood pressure, blood lipids, fasting glucose
timeFrame: November 2007
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Heinrich-Heine-University, Rhineland State Clinics Düsseldorf
state: Rhineland State
Study officials:
affiliation: Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf, Rhineland State Clinics Düsseldorf, Bergische Landstrasse 2, 40629 Düsseldorf, Germany
name: Joachim Cordes, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Psychiatry, Offenbach
name: Ansgar Klimke, Prof
role: STUDY_DIRECTOR
affiliation: Technical University of Munic
name: Hans Hauner, Prof
role: STUDY_DIRECTOR
References:
citation: Hauner H, Rohrig K, Hebebrand J, Skurk T. No evidence for a direct effect of clozapine on fat-cell formation and production of leptin and other fat-cell-derived factors. Mol Psychiatry. 2003 Mar;8(3):258-9. doi: 10.1038/sj.mp.4001246. No abstract available.
Clinical trial NCT01112202: Effect of Dabigatran on Coagulation parameters-an ex Vivo Study
Official title: Effect of Dabigatran on Coagulation Parameters in Patients Undergoing Elective Orthopaedic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Effect of Dabigatran in Laboratory Coagulation Parameters
Keywords: direct thrombin inhibitors
Dabigatran
Coagulation parameters
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2010-04-28
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients after hip or knee replacement surgery treated with Dabigatran 150-220 mg/d

Brief summary: Dabigatran represent a new class of promising anticoagulation agents. As an oral direct thrombin inhibitor it has been effective in preventing venous thromboembolism in patients undergoing elective orthopaedic surgery. This ex vivo study is undertaken to investigate the ex-vivo effects of Pradaxa® on different coagulation parameters.

Detailed description: This mono-centric, open-label study is undertaken to validate the effects of Dabigatran on coagulation parameters in plasma samples of 70 patients after hip or knee replacement surgery treated with Dabigatran 150-220 mg/d. Plasma samples are obtained by blood collection before, after 2 hours and after 12-14 hours after Dabigatran dosing in steady state (on 3rd - 5th day).

Eligibility criteria: Inclusion Criteria:

* Age \> 18 y

Exclusion Criteria:

* Hemorrhagic disorder
* Liver disease
* Anemia
* Severe renal impairment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: Johann Wolfgang Goethe University Hospital
Study officials:
References:
Clinical trial NCT01123902: Effectiveness of a Hand-held Fan for Breathlessness
Official title: Effectiveness of a Hand-held Fan for Breathlessness: a Randomised Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Lung Cancer or Secondary Lung Metastases
COPD III/IV
Keywords: Breathlessness
Dyspnea
Hand-held fan
Palliative Care
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2010-05-14
Enrollment: 109
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: Breathlessness is a common and distressing symptom in advanced disease. A hand-held fan is a simple device which has shown, when directed to the patients face, to be effective in relieving breathlessness.

This phase II trial aims to determine the potential effectiveness of a hand-held fan to relieve breathlessness over time and to evaluate the recruitment into the study and the acceptance of the intervention and the control.

The intervention to be tested is a HHF directed to the area of the face innervated by the second and third trigeminal nerve branches. A wristband was chosen as control under the assumption that distraction could serve as a placebo.

The main outcomes for this study are uptake into the trial (proportion of patients from the longitudinal study participating in the RCT), adherence to the study, and use and acceptance of the intervention and the control. The main outcome for assessing the effect of the hand-held fan is change of severity of breathlessness between baseline and one month and two months, respectively.


Eligibility criteria: Inclusion Criteria:

* Patients were included if they reported breathlessness that had an impact on their daily life and were suffering from one of the following conditions:
* Advanced malignant disease (primary lung cancer or secondary lung metastases/ lung involvement due to cancer)
* COPD stage III (severe) and IV (very severe) according to GOLD criteria.\[7\]

Exclusion Criteria:

* Unable to provide informed consent
* Too ill to be interviewed and not fluent or illiterate in German

Primary outcomes:
measure: change of severity of breathlessness
timeFrame: between baseline and one month
Secondary outcomes:
measure: use and acceptance of the intervention and the control
timeFrame: over 6 months
measure: adherence to the study
timeFrame: 6 months
measure: uptake into the trial (proportion of patients from the longitudinal study participating in the RCT)
timeFrame: 18 months
measure: change of severity of breathlessness
timeFrame: baseline and two months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: King's College London
Study officials:
affiliation: King's College London
name: Claudia Bausewein, PhD MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bausewein C, Booth S, Gysels M, Kuhnbach R, Higginson IJ. Effectiveness of a hand-held fan for breathlessness: a randomised phase II trial. BMC Palliat Care. 2010 Oct 19;9:22. doi: 10.1186/1472-684X-9-22.
Clinical trial NCT00551902: Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes
Official title: Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Glaucoma
Keywords: Glaucoma
trabeculectomy
anterior chamber maintainer
anterior chamber infusion
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Glaucoma Research & Education Group
First posted: 2007-10-31
Enrollment: 0
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: In the treatment of glaucoma, trabeculectomy surgery provides a drainage system for the eye and allows for the lowering of the pressure inside the eye. The flow through the surgically created fistula determines the intraocular pressure. Titrating suture tightness is important to achieving the desired post-operative intraocular pressure. This process is not straightforward and intraocular pressures are often too high or too low post-operatively.

Detailed description: The use of an anterior chamber infusion system to deliver fluid into the eye during trabeculectomy surgery may be of benefit in this process and may have other benefits as well which may result in better outcomes.

Thus, the hypothesis of this study is that the use of an anterior chamber infusion system improves success of trabeculectomy surgery.

Eligibility criteria: Inclusion Criteria:

* 18 years of age
* One of the following diagnoses:

  * primary open angle glaucoma
  * chronic angle closure glaucoma
  * pseudo exfoliation glaucoma
  * pigment dispersion glaucoma

Exclusion Criteria:

* unable to provide consent or return for follow up

Primary outcomes:
measure: surgical success: intraocular pressure lowered by 30% and functional filtering bleb
timeFrame: 2 weeks, 1 month, 3 months, 6 months and 1 year post surgery
Secondary outcomes:
measure: Need for laser suture lysis
timeFrame: any point post operatively
measure: complications: aqueous misdirection, suprachoroidal hemorrhage, anterior chamber shallowing
timeFrame: any time post operatively
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Hotel Dieu Hospital, Queen's University
state: Ontario
city: Toronto
country: Canada
facility: Toronto Western Hospital, University of Toronto
state: Ontario
Study officials:
affiliation: Queen's University
name: Robert J Campbell, MD
role: PRINCIPAL_INVESTIGATOR
References: