louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04377321: Colchicine Has Anti-diabetic Effect
Official title: Colchicine Has Anti-diabetic Effect and May be an Option for Type 2 Diabetes Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Treatment Adherence
Keywords: type 2 diabetes
colchicine
inflammatory markers
Lead sponsor: Ministry of Health and Population, Egypt
Sponsor class: OTHER_GOV
First posted: 2020-05-06
Enrollment: 150
Sex: ALL
Minimum age (years): 35
Maximum age (years): 55
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Observational cohort prospective study with following of 150 newly diagnosed type 2 diabetes patients who were in 3 groups, had been monitored in a private clinic, each group 50 patients number, with 30 females and 20 males after written consent from all patients. The ages of all patients were between 35 and 55 years.

Brief summary: Colchicine has antidiabetic effect and may be an option for type 2 diabetes management

Detailed description: Observational cohort prospective study with following of 150 newly diagnosed type 2 diabetes patients who were in 3 groups, had been monitored in a private clinic, each group 50 patients number, with 30 females and 20 males after written consent from all patients. The ages of all patients were between 35 and 55 years.

The aim of this study was to evaluate colchicine effect on A1C of newly diagnosed type2 diabetes compared to the metformin and control group on diet only.

The first group patients received colchicine 0.5twice daily for 6 months, the second group received metformin 1gm twice daily, the third group patients were on diet only. During the period of treatment, the investigators followed the patients if there were side effects of the drugs used. No side effects were monitored during the period of treatment except for gastric upset in some patients using metformin

Eligibility criteria: Inclusion Criteria:

* type 2 diabetes newly diagnosed age 35- 55 years

Exclusion Criteria:

* severe anemia hypothyroidism and hyperthyroidism moderate to severe liver or kidney disease

Primary outcomes:
measure: colchicine for treatment of type diabetes patients
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Mahmoud Younis
Study officials:
References:
Clinical trial NCT04708821: DEXTENZA Therapy for Treatment of Allergic Conjunctivitis
Official title: DEXTENZA Versus Topical Steroid or Antihistamine Therapy for Treatment of Allergic Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bilateral Conjunctivitis (Disorder)
Lead sponsor: Clinical Research Center of Florida
Sponsor class: OTHER
Collaborators: name: Ocular Therapeutix, Inc.
First posted: 2021-01-14
Enrollment: 31
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: This prospective, open-label, single-center, randomized, investigator-sponsored clinical study seeks to compare patient-reported and clinical outcomes with DEXTENZA versus topical steroid or antihistamine treatment in patients with allergic conjunctivitis


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age
* Provide written informed consent and sign HIPAA form
* Be willing and able to follow all instructions and attend all study visits
* Be able and willing to discontinue wearing contact lenses throughout the study period
* Have a BCVA of ≥50 ETDRS letters (20/100 Snellen equivalent or better) in each eye as measured at Screening visit
* Have urine pregnancy testing for women considered capable of becoming pregnant; not be lactating; and agree to use a medically acceptable form of birth control throughout the study period
* Have a positive history of bilateral ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen as confirmed by the allergy testing at the Screening visit

Exclusion Criteria:

* • Known contraindications or sensitivities to the use of any of the medications required per protocol, including known steroid responders

  * Have any ocular condition that in the opinion of the Investigator could affect the subject's safety or study parameters (including, but not limited to uncontrolled narrow angle glaucoma, severe blepharitis, follicular conjunctivitis, iritis, pterygium, dry eye diagnosis, or active ocular infection)
  * Have a known history of retinal detachment, diabetic retinopathy, or active retinal disease
  * Use of systemic, inhaled, or nasal steroids
  * Use of new systemic antihistamine use within 30 days of Screening visit
  * Use of ocular or topical non-steroidal anti-inflammatory drugs (NSAIDs)
  * Use of lid scrubs
  * Use of decongestants
  * Use of immunotherapeutic agents
  * Use of monoamine oxidase inhibitors (MAOIs)
  * Have a congenital or ocular anomaly or anomaly of the punctum that may preclude placement of DEXTENZA

Primary outcomes:
measure: Patient-reported treatment preference of self-administered topical therapy versus physician-administered therapy at Day 30 (final visit)
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Pompano Beach
country: United States
facility: Clinical Research Center of Florida
state: Florida
Study officials:
References:
Clinical trial NCT01568021: Post Market Surveillance of OZURDEX® for Branch Retinal Vein Occlusion (BRVO) and Central Retinal Vein Occlusion (CRVO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Vein Occlusion
Macular Edema
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-04-02
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 with BRVO and CRVO prescribed OZURDEX®

Brief summary: This multicenter observational study will assess the efficacy and tolerability of OZURDEX® in clinical practice, and will assess the time at which patients are considered for retreatment.


Eligibility criteria: Inclusion Criteria:

* Macular Edema
* Prescribed OZURDEX®

Exclusion Criteria:

* None

Primary outcomes:
measure: Time to First Re-treatment
timeFrame: 1 Year
Secondary outcomes:
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) Score
timeFrame: Baseline, Weeks 12, 24 and 48
measure: Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT)
timeFrame: Baseline, Weeks 12, 24 and 48
Other outcomes:
Locations:
city: Glostrup
country: Denmark
city: Oslo
country: Norway
city: Uppsala
country: Sweden
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00162721: The Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas
Official title: Phase III Study About the Effects of the Addition of Polychemotherapy to Adjuvant Radiotherapy in the Treatment of Non-Metastatic Uterine Sarcomas
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Uterine Sarcoma
Keywords: Uterine sarcoma non metastatic
Lead sponsor: Gustave Roussy, Cancer Campus, Grand Paris
Sponsor class: OTHER
First posted: 2005-09-13
Enrollment: 270
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Phase III study about the effects of the addition of polychemotherapy to adjuvant radiotherapy in the treatment of non-metastatic uterine sarcomas.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed uterine sarcoma (rereading in reference centers)
* Leiomyosarcoma, adenosarcoma, carcinosarcoma and high grade endometrial stromal sarcoma
* All stages \<= stage III (FIGO modified for endometrial carcinoma)
* Full surgical exeresis
* Age \>= 18 years and physiological age \<= 65 years
* Negative extension check-up (thoracic and abdomino-pelvic TDM)
* Performance status (PS) \<= 2 (ECOG)
* Normal haematologic functions (absolute neutrophil count \> 1,500/mm3, platelets \> 100,000/mm3)
* Serum creatinine \< 1.25 x ULN
* Good hepatic check-up (total serum bilirubin \< 1.5 x ULN; AST or ALT \< 2.5 x ULN)
* Absence of neuropathy \> grade 1
* Left ventricular ejection fraction \> 50% (by isotopic or ultrasound scan determination)
* Written informed consent

Exclusion Criteria:

* Low grade endometrial stromal sarcoma
* Time since surgery \> 8 weeks
* Specific contraindications to the studied treatment (cardiac, kidney, or hepatic ones)
* Antecedents or evolutive psychiatric disorder
* Concurrent active infection or other serious uncontrolled systemic disease
* Antecedents of cancer but a cutaneous basocellular one or an in situ epithelioma of the cervix

Primary outcomes:
measure: Effects of the addition of an adjuvant chemotherapy to adjuvant pelvic radiotherapy on a 3 year event-free survival in the treatment of localized uterine sarcomas
Secondary outcomes:
measure: Effects of the addition of an adjuvant chemotherapy to adjuvant pelvic radiotherapy on overall survival
measure: Evaluation of global toxicity of the treatment in each arm
Other outcomes:
Locations:
city: Villejuif
country: France
facility: Institut Gustave Roussy
Study officials:
affiliation: Gustave Roussy, Cancer Campus, Grand Paris
name: Patricia Pautier, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00931021: Smoking Cessation Treatment for Head and Neck Cancer Patients
Official title: Smoking Cessation Treatment for Head and Neck Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Smoking Cessation
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2009-07-02
Enrollment: 7
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: This is a pilot research study examining the use of varenicline (Chantix) and the nicotine patch. The study is designed to find out whether one of these medications is more effective for smoking cessation with head and neck cancer patients. The study has three parts: 1) two intake sessions; 2) an 8-week treatment phase, and 3) a 3-month follow-up.


Eligibility criteria: Inclusion Criteria:

* age 18 or older
* smoking 10 or more cigarettes per day
* diagnosed with and completed an initial course of treatment for any type of head and neck cancer
* life expectancy of 12 months or more

Exclusion Criteria:

* history of allergic reactions to adhesives
* unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia
* females of childbearing potential who are pregnant, nursing, or not practicing effective contraception

Primary outcomes:
measure: To develop an effect size estimate for smoking cessation defined as continuous abstinence over the last 4 weeks of treatment for 2 mg varenicline compared to nicotine patch.
timeFrame: Eight weeks
Secondary outcomes:
measure: To examine tolerability of 2 mg varenicline and the 21 mg nicotine patch in smokers who have been diagnosed with head and neck cancer.
timeFrame: Eight weeks
measure: To examine the effects of smoking cessation, varenicline and nicotine patch on markers of inflammation.
timeFrame: Eight weeks
measure: To examine the effect of varenicline and nicotine patch on alcohol consumption.
timeFrame: Eight weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Benjamin Toll, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02290821: Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects With Acute Blunt Trauma Injuries
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel (DSG) 1% Applied Four Times Daily in Subjects With Acute Blunt Soft Tissue Injuries/Contusions of the Limbs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Blunt Soft Tissue Injuries/Contusions
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-11-14
Enrollment: 215
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction of the pain associated with acute blunt trauma injuries.


Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged 16 years and over Fresh impact injury of the upper or lower limbs, not requiring admittance to hospital \& meeting baseline pain intensity level Anticipated time between injury and treatment must be ≤ 6 hours

Exclusion Criteria:

* Pain medication prior to randomization Topical analgesic or anti-inflammatory treatment over the previous month in the area to be treated Any physical impairment that would influence efficacy assessments, such as peripheral or central neurological disease, significant back pain, painful conditions of the upper or lower extremities Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Sum of Pain Intensity Differences Over 24 Hours After Initiating Treatment (SPID 24)
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Bradenton
country: United States
facility: US Site
state: Florida
city: Port Orange
country: United States
facility: US Site
state: Florida
city: Boise
country: United States
facility: US Site
state: Idaho
city: Grand Rapids
country: United States
facility: US Site
state: Michigan
city: Omaha
country: United States
facility: US Site
state: Nebraska
city: Brooklyn
country: United States
facility: US Site
state: New York
city: Columbus
country: United States
facility: US Site
state: Ohio
city: State College
country: United States
facility: US Site
state: Pennsylvania
city: Bellaine
country: United States
facility: US Site
state: Texas
city: Houston
country: United States
facility: US Site
state: Texas
Study officials:
References:
Clinical trial NCT01812421: A Nested Case-control Study on the Secondary Prevention of Ischemic Stroke and TIA by Hypertension Health Education Protocol (HHEP): The Post-Stroke Preventive Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: To Investigate the Relationship Between the Adherence of HHEP After ISTIA and Stroke Recurrence or Cardiovascular Events.
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2013-03-18
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: PREVENTION

Brief summary: Patients with a diagnosis of ischemic stroke or TIA (ISTIA), who are treated at hospital are asked to participate in our pre specified hypertension health education protocol (HHEP) after discharge from our hospital.HHEP was used as secondary prevention treatments of stroke and cardiovascular diseases.

HHEP consists of several items such as controlling the patient's hypertension level, monitoring the adherece of antihypertensive agents, reducing risk factors of hytertension like tobacco smoking, obesity, and motivating the patient to physical activity and to a healthy diet.

Patients will receive visits by a study nurse with the aim of supervising, monitoring, and recording the adherence of HHEP. The patients will be classified as different adherence level at the end of the study according to their adherence condition.

This study is aimed at testing the hypothesis that controlling hypertension and its risk factors was more effective than those do not receive HHEP in reducing the recurrence of stroke and cardiovascular diseases.


Eligibility criteria: Inclusion Criteria:

Participants were eligible for this observational cohort study if they were age 18 years or older; Hospitalized for a primary diagnosis of acute ischemic stroke or Transient Ischemic Attack (TIA) and concurrently diagnosed as hypertension; Provided consent to participate, and their data can be collected from Medical Record System of our hospital.

Exclusion Criteria:

We will exclude people who are onset of symptoms 3 months after their ischemic stroke or TIA; The stroke events occurred before the baseline survey were identified from the Hospital Discharge Register retrospectively and excluded from the analyses.

Primary outcomes:
measure: Nonfatal vascular events: ischemic or hemorrhagic stroke recurrence (ICD-9 431 or ICD-10 I61), or myocardial infarction(MI) (ICD-9 410 or ICD-10 I21).
timeFrame: 1 year
Secondary outcomes:
measure: vascular death (death within 30 days after a vascular event) and all-cause mortality.
timeFrame: 1 year
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Brain Center,Guangdong Province Hospital of Traditional Chinese Medicine
state: Guangdong
Study officials:
References:
Clinical trial NCT04240821: Theophylline for Treatment of Pseudohypoparathyroidism
Official title: Open-Label Extension Study of Theophylline for Treatment of Pseudohypoparathyroidism
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE2
Conditions: Pseudohypoparathyroidism
Pseudohypoparathyroidism Type 1a
Albright Hereditary Osteodystrophy
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2020-01-27
Enrollment: 34
Sex: ALL
Minimum age (years): 2
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is an open-label extension study
Primary purpose: TREATMENT

Brief summary: Pseudohypoparathyroidism is a genetic disorder with limited treatment options, characterized by early-onset obesity, short stature, hormone resistance and cognitive impairment. This phase 2 clinical trial will test the efficacy of theophylline, a phosphodiesterase inhibitor, in pseudohypoparathyroidism. We hypothesize that theophylline will cause weight loss, improve glucose tolerance and decrease hormone resistance in children and young adults.

Detailed description: Trial Objectives

1. The primary objective of this study is to evaluate the long-term safety of theophylline in patients with PHP.
2. The secondary objectives of this study are to evaluate changes in BMI, hormone resistance and epiphyseal closure associated with theophylline treatment of patients with PHP.

Study Design The proposed study is a single center, 24-month open label extension clinical trial for patients with PHP who complete the randomized clinical trial.

Eligibility criteria: Inclusion Criteria:

* 1. Successful completion of the randomized clinical trial "Phase 2 Study of Theophylline Treatment of Pseudohypoparathyroidism IND 133103 (11/1/2016)".

Exclusion Criteria:

1. History of a seizure disorder unrelated to hypocalcemia
2. History of a cardiac arrhythmia (not including bradycardia)
3. Hepatic insufficiency including cirrhosis and acute hepatitis (AST or ALT \>3x upper limit of normal)
4. Congestive heart failure
5. Current cigarette use or alcohol abuse
6. Pregnancy or intention to become pregnant during the next year
7. Active peptic ulcer disease
8. Current use of medications known to effect theophylline levels
9. History of hypersensitivity to theophylline or other medication components
10. Unable to comply with study procedures in the opinion of the investigator

Primary outcomes:
measure: Adverse Events
timeFrame: 24 months
Secondary outcomes:
measure: BMI
timeFrame: 24 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Ashley Shoemaker, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002721: Doxorubicin Plus Estramustine in Treating Patients With Metastatic Prostate Cancer
Official title: A PHASE I TRIAL OF ESTRAMUSTINE PHOSPHATE AND DOXORUBICIN IN HORMONE REFRACTORY METASTATIC PROSTATE CANCER
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostate Cancer
Keywords: recurrent prostate cancer
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2004-05-26
Enrollment: 18
Sex: MALE
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: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of doxorubicin plus estramustine in treating patients with metastatic recurrent prostate cancer that does not respond to hormone therapy.

Detailed description: OBJECTIVES: I. Estimate the maximum tolerated dose of weekly intravenous doxorubicin (DOX) that can be given in combination with oral estramustine (EM) in patients with metastatic prostate cancer refractory to treatment with hormonal agents. II. Assess the frequency of expression of the multidrug resistance phenotype in biopsy specimens from these patients. III. Assess the response to DOX/EM in these patients.

OUTLINE: 2-Drug Combination Chemotherapy. Doxorubicin, DOX, NSC-123127; Estramustine, EM, NSC-89199.

PROJECTED ACCRUAL: Three to 18 patients will be entered.

Eligibility criteria: DISEASE CHARACTERISTICS: Biopsy proven metastatic prostate cancer Biopsy requirement waived at principal investigator's discretion if new disease site technically inaccessible and PSA elevated Recurrent disease following orchiectomy, estrogen, or gonadotropin-releasing hormone agonist therapy If previously irradiated: Progressive disease outside prior radiotherapy field required No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL ALT/AST less than 3 times greater than normal Renal: Not specified Cardiovascular: Left ventricular ejection fraction at least 45% No NYHA class III/IV status No unstable angina Other: No Crohn's disease, ulcerative colitis, or other inflammatory bowel syndrome

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior doxorubicin or estramustine Endocrine therapy: See Disease Characteristics At least 30 days since flutamide Estrogen or gonadotropin-releasing hormone agonists discontinued prior to treatment Radiotherapy: At least 6 weeks since radiotherapy Surgery: Not specified

Primary outcomes:
measure: Respond to therapy
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico Cancer Research & Treatment Center
state: New Mexico
Study officials:
affiliation: University of New Mexico Cancer Center
name: Anthony Y. Smith, MD
role: STUDY_CHAIR
References: