louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00290030: ALFAURUS : A DB Randomized Parallel Group Study of Alfuzosin 10mg OD vs Placebo in the Management of AUR in Patients With a 1st Episode Due to BPH
Official title: A Double-Blind Randomized Parallel Group Study of Alfuzosin 10mg OD Versus Placebo in the Management of Acute Urinary Retention in Patients With a First Episode Due to Benign Prostatic Hyperplasia (BPH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Prostatic Hyperplasia
Acute Urinary Retention
Keywords: acute urinary retention
International Prostate Symptom Score (IPSS)
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-02-10
Enrollment: 800
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the efficacy of alfuzosin 10mg OD in the management of acute urinary retention associated with BPH.

To assess the safety of alfuzosin in this population and health care consumption.

Detailed description: Double-blind, placebo controlled, randomized Multicenter, Phase III study comparing 2 parallel groups (alfuzosin 10mg OD or placebo) in patients with a first episode of acute urinary retention related to BPH.The acute episode is managed with catheterization and with study drug treatment for 2 to 3 days, followed by an active voiding trial to assess the patients' ability to void after catheter removal.

Those patients who successfully void will continue their randomized treatment for a total treatment duration of 6 months. For all patients who are prematurely withdrawn during the study, a post-study (clinic or phone) visit will be performed for collection of health care consumption data.

Eligibility criteria: Inclusion Criteria:

* Male aged over 50 years
* Having given his written consent
* Presenting with a first episode of painful acute urinary retention related to BPH
* With a catheterized urine volume between mL and mL at the time of retention

Exclusion Criteria:

* Associated urological diseases / troubles (e.g. infection or surgery of prostate, urinary retention f neurogenic origin
* Iatrogenic causes of urinary retention

Primary outcomes:
measure: Successful voiding in initial period (using an active voiding trial)
measure: No relapse during the 6 month treatment period
measure: No need / indication for surgery during the initial or 6 month treatment periods
Secondary outcomes:
measure: To assess the safety of alfuzosin in this population, and health care consumption
Other outcomes:
Locations:
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00696930: Study to Evaluate the Efficacy and Safety of 90Y-SMT487 in Subjects With Symptomatic Malignant Carcinoid Tumors
Official title: A Phase II Open-label Multi-center Study to Evaluate the Efficacy and Safety of 90Y-SMT487 in Subjects With Symptomatic Malignant Carcinoid Tumors
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Malignant Carcinoid Tumor
Keywords: Malignant Carcinoid Tumors
Lead sponsor: Molecular Insight Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2008-06-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Subjects will be screened to determine OctreoScan® uptake. And upon meeting the eligibility criteria, 90 subjects will complete a symptom assessment scale at baseline and throughout the study at specific time points. Actual treatment will consist of three six-week cycles of a fixed total dose of 13.3 GBq (360 mCi) of 90Y-SMT487. The total dose will be divided into three equal doses and administered as a single activity of 4.4 GBq (120 mCi) of 90Y-SMT487 once every six weeks for three cycles. An amino acid infusion will be administered along with each dose. Long-term follow up will occur at 6 and 12 months after Day 1/ Cycle 1. Survival will be assessed every six months.


Eligibility criteria: Inclusion Criteria:

1. Life expectancy \> 6 months.
2. Subjects must have distant metastases.
3. Subjects must be able to discontinue Sandostatin LAR treatment for at least 1 month prior to Day 1/Cycle 1; last dose of Sandostatin LAR must be 60 days or more prior to the first OctreoTher™ dose. For subcutaneous Sandostatin discontinuation should be 12 hours. Subjects taking other long acting somatostatin analogues must discontinue the analogue at least 2 times the dosing interval.
4. Upon baseline disease assessment, all subjects must have at least 1 measurable site of disease that either has never been irradiated or if the measurable lesion has been previously irradiated; this same lesion has since demonstrated progression base don the SWOG response criteria.
5. Subjects must state or agree with the statement that "I have symptoms from my cancer that bother me." Subjects must have failed to gain complete symptom control despite an optimal attempt at somatostatin therapy in the judgement of their physician.

Exclusion Criteria:

1. Chemotherapy, biologic therapy or other investigational therapy within 4 weeks of Day 1.
2. Surgery, hormonal therapy (not including somatostatin analogues) or radiation, within 2 weeks of Day 1.
3. Subjects with know brain metastases unless these metastases have been treated and stabilized for at least six months prior to study start.
4. Subjects who received high dose OctreoScan therapy or other radiolabelled somatostatin therapy or other systemic radiolabelled therapy (e.g. MIBG) for treatment of metastatic carcinoid.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05870930: Bioavailability Study of Cretan Carob
Official title: Bioavailability of Phenolic Compounds Following the Consumption of a Carob Beverage
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Diet
Keywords: carob
phenolic compound bioavailability
metabolites
bioavailability in humans
Imera carob
Lead sponsor: Harokopio University
Sponsor class: OTHER
First posted: 2023-05-23
Enrollment: 15
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is an interventional, open-label, single-group, bioavailability postprandial study. The aim of the study is to evaluate the bioavailability of phenolic compounds of a beverage prepared with Cretan carob powder of the Imera cultivar in healthy individuals after consumption.

Detailed description: This is an interventional, open-label, single-group, bioavailability postprandial study. The aim of the study is to evaluate the bioavailability of active constituents of a beverage with carob powder in healthy individuals after consumption. Fifteen apparently healthy male adults of normal body fat mass (non-obese) will be enrolled based on certain inclusion and exclusion criteria. After enrollment, the volunteers will undergo a medical and dietary assessment and will be instructed to follow a low-phytochemical diet (washout) for five consecutive days, excluding from their diet sources of phytochemicals, i.e., fruits, vegetables, legumes, coffee, tea. Compliance with the low-phytochemical diet will be assessed with a 24 h recall during and at the end of the washout period. On the day of the experiment following washout, volunteers will be given a carob beverage (blood samples will be collected 0.5, 1.0, 1.5, 2.0, 2.5, 3.0, 4-6 h postprandially). Time intervals 0-6h will be used for LC-ESI-MS/MS approach in order to identify putative polyphenol metabolites related to carob consumption.

Eligibility criteria: Inclusion Criteria:

* healthy male adults
* normal body fat mass

Exclusion Criteria:

* obesity (according to body fat mass)
* Type 1 Diabetes, cardiovascular diseases, hypertension
* thyroid disorder, liver disease, kidney disease
* gastrointestinal disease
* mental illness
* use of nutraceutical supplements or natural products for weight loss
* dietitians/nutritionists

Primary outcomes:
measure: Identification of putative polyphenol metabolites related to carob consumption.
timeFrame: Six hours
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Andriana Kaliora
Study officials:
affiliation: Harokopio University of Athens, Greece
name: Andriana C Kaliora
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05287230: Developing a Trauma-focused Intervention for Older Adults Living With HIV
Official title: Developing a Trauma-focused Intervention for Older Adults Living With HIV
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Trauma
Hiv
Aging
Lead sponsor: University of South Carolina
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-03-18
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators are adapting the LIFT and REFLECT interventions for older adults living with HIV who have been exposed to childhood sexual abuse.


Eligibility criteria: Inclusion Criteria:

* Living with HIV
* 50 years old or older
* \<100 % ART adherence
* depressive symptoms

Exclusion Criteria:

* Not living with HIV
* \<50 years
* 100% ART Adherence

Primary outcomes:
measure: ART adherence
timeFrame: Baseline
measure: ART adherence
timeFrame: 6 weeks
measure: ART adherence
timeFrame: 3 months
measure: ART adherence
timeFrame: 6 months
Secondary outcomes:
measure: Health-related quality of life
timeFrame: Baseline
measure: Health-related quality of life
timeFrame: 6 weeks
measure: Health-related quality of life
timeFrame: 3 months
measure: Health-related quality of life
timeFrame: 6 months
Other outcomes:
measure: Depressive symptoms
timeFrame: Baseline
measure: Depressive symptoms
timeFrame: 6 weeks
measure: Depressive symptoms
timeFrame: 3 months
measure: Depressive symptoms
timeFrame: 6 months
Locations:
city: Columbia
country: United States
facility: University of South Carolina
state: South Carolina
Study officials:
affiliation: University of South Carolina
name: Monique J Brown, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01027130: Haptoglobin and Preeclampsia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia
Lead sponsor: Bnai Zion Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-12-07
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women coming to give birth at our medical center

Brief summary: The purpose of this study is to show that a certain protein called haptoglobin protects against preeclampsia which is a common pregnancy complication.


Eligibility criteria: Inclusion Criteria:

* all women

Exclusion Criteria:

* women with hypertension

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Bnai-Zion Medical Center
Study officials:
References:
Clinical trial NCT02939430: Sugammadex Reversal of Neuromuscular Blockade and Postoperative Bleeding
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blood Coagulation Tests ( INR, APTT)
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-10-20
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Sugammadex is new drug that is used for reversal of rocuronium induced muscle relaxation. benefits of reversal of neuromuscular blockade appears to be of great value in living donor liver transplant recipients. However, Few Clinical reports have investigated the anticoagulant effect of sugammadex. In this study, effects of sugammadex on bleeding profile of living donor liver transplantation will be investigated.


Eligibility criteria: Inclusion Criteria:

* all candidates for living donor liver transplantation

Exclusion Criteria:

* massive intraoperative bleeding manifestations of early graft dysfunction

Primary outcomes:
measure: activated partial thromboplastin tile in seconds
timeFrame: 30 min
Secondary outcomes:
measure: international normalized ratio in second
timeFrame: 30 min
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura university
state: Dkahleya
city: Mansoura
country: Egypt
facility: Gastroenterology center
Study officials:
References:
Clinical trial NCT00040430: Study of 111In-DAC as a Medical Imaging Agent for the Detection of Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: Copharos
Sponsor class: INDUSTRY
First posted: 2002-06-28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to investigate the safety and imaging ability of 111In-DAC when used with planar and SPECT imaging for the detection of breast cancer.


Eligibility criteria: Inclusion Criteria

Patients will be eligible for the study if they:

* Are non-pregnant, non-lactating females 18 years of age or older(must agree to use an appropriate and effective method of birth control during the study and for 2 weeks after study)
* Are being evaluated for a known or suspected breast tumor (must present with either a mammographic abnormality 10mm or larger or a mammographically occult but palpable abnormality of the breast)
* Have been previously scheduled for biopsy or surgical excision of the known or suspected tumor of the breast
* Have signed an informed consent form

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have a history or suspicion of significant allergic reaction or anaphylaxis to any of the 111In-DAC components
* Have a clinically unstable medical condition or opportunistic infection, a life-threatening disease state, impaired renal or hepatic function or are immunosuppressed
* Are taking or have taken part in any investigational study within 30 days of start of study
* Have received an indium agent within 30 days of start of study
* Are not able to remain immobile during scanning time
* Have taken drugs that may damage the kidneys within 2 weeks of start of study
* Have abnormal laboratory test results: hemoglobin \< 9.5 gms/dl, serum creatinine \> 1.5 mg/100ml, alkaline phosphatase 2X the upper limit of normal
* Have undergone an excisional and/or needle localization biopsy within 4 days prior to start of study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Roseville
country: United States
facility: Sutter Roseville Medical Center
state: California
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
References:
Clinical trial NCT02397330: is There an Alternative to Ultrasound Guided Interscalene Block?
Official title: the Association of Ultrasound Guided Suprascapular and Supraclavicular Nerve Block Provides Adequate Analgesia in Comparison With Ultrasound Guided Interscalene Block
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Regional Anesthesia
Interscalene Block
Shoulder Surgery
Lead sponsor: Tunisian Military Hospital
Sponsor class: OTHER
First posted: 2015-03-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Interscalene brachial plexus block is the gold standard for perioperative pain management in shoulder surgery. However, this technique would have side effects and potential serious complications. The aim of this study is to compare between the combination of ultrasound guided suprascapular and supraclavicular nerve blocks versus ultrasound guided interscalene brachial plexus block for post operative analgesia after shoulder instability surgery with latarjet procedure.


Eligibility criteria: Inclusion Criteria:

* ASA physical status I-III
* 18-75 years of age, inclusive
* shoulder surgery (LATARJET technique)

Exclusion Criteria:

* contraindications to brachial plexus block (e.g., allergy to local anesthetics, coagulopathy, malignancy or infection in the area)
* existing neurological deficit
* pregnancy
* history of neck surgery or radiotherapy
* severe respiratory disease
* inability to understand the informed consent and demands of the study

Primary outcomes:
measure: Visual Analogic Scale
timeFrame: until 48 hours postoperative
Secondary outcomes:
measure: time to perform the blocks
timeFrame: up to 5 minutes
measure: patient satisfaction
timeFrame: 48 hours post performing nerves blocks
measure: occurrence of complications
timeFrame: 48 hours post performing nerves blocks
measure: total dose of morphine consumption in mg
timeFrame: during 48 hours post operative
Other outcomes:
Locations:
Study officials:
References:
citation: Trabelsi W, Ben Gabsia A, Lebbi A, Sammoud W, Labbene I, Ferjani M. Suprascapular block associated with supraclavicular block: An alternative to isolated interscalene block for analgesia in shoulder instability surgery? Orthop Traumatol Surg Res. 2017 Feb;103(1):77-83. doi: 10.1016/j.otsr.2016.10.012. Epub 2016 Dec 2.
Clinical trial NCT04448730: Polycystic Ovary Syndrome and BETATROPHIN
Official title: Can the Betatrophin be a Reliable Marker of Insulin Resistance in Normal Weight and Overweight Women With Polycystic Ovary Syndrome?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary
Obesity
Keywords: Betatrophin
PCOS
obesity
insulin resistance
Lead sponsor: Kayseri Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2020-06-26
Enrollment: 73
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Comparison of the Betatrohin serum marker of insulin resistance in normal weight and overweight women with polycystic ovary syndrome cases.

Brief summary: This is an original study giving an information about the association body mass index, polycystic ovary syndrome and betatrophin.

Detailed description: Introduction: Betatrophin is a protein hormone which has a significant role in glucose homeostasis and lipid metabolism. The aim of this study is to compare the levels of serum betatrophin in overweight and normal weight women with PCOS.

Material and Method: Thirty-five patients normal weight women with PCOS (BMI\<25) and 38 obese women with PCOS (BMI≥25) were included in this prospective, cross-sectional study. Patients were selected according to Rotterdam criteria. Serum betatrophin levels were studied by ELISA method and then compared between these two groups besides the following additional parameters as waist circumference/hip circumference ratio, fasting blood glucose, 75 g OGTT (oral glucose tolerance test) results and HOMA-IR levels.

Eligibility criteria: Inclusion Criteria:

-Polycystic ovary syndrome according to 2003 Rotterdam PCOS Consensus diagnostic criteria

Exclusion criteria

* pregnancy,
* an additional systemic disease (i.e.,hyperprolactinemia, thyroid dysfunction, liver or kidney diseases, cardiovascular disease, hyperlipidemia, type 1 or type 2 diabetes, chronic or acute infection within the previous 30 days),
* morbid obesity,
* smoking,
* the use of medications for contraception, androgen excess, hypertension, hyperglycemia or dyslipidemia at least 3 months before the study.

Primary outcomes:
measure: serum Betatrophin levels
timeFrame: 30 min
Secondary outcomes:
measure: Waist/hip ratio
timeFrame: 5 min
measure: 75 gr OGTT(oral glucose tolerance test)
timeFrame: 2 hours
measure: BMI (body mass index)
timeFrame: 5 minute
Other outcomes:
Locations:
city: Kocasinan
country: Turkey
facility: Kayseri Doğumevi
state: Kayseri
Study officials:
References:
Clinical trial NCT00399230: A Comparison of Optive in Patients Previously Using Systane for the Treatment of Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Lead sponsor: Innovative Medical
Sponsor class: INDUSTRY
First posted: 2006-11-14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To evaluate the effectiveness of NGT (Optive) vs. Systane Tears for patients with moderate to severe dry eye disease.


Eligibility criteria: Inclusion Criteria:

* · Dry eye disease diagnosis

  * Patients must currently be using Systane tears at least once a day and for at least 1 month.
  * Normal lid position and closure
  * Male or female of legal age of consent
  * Informed consent has been obtained
  * Likely to complete all required follow-up visits

Exclusion Criteria:

* · Concurrent enrollment in an investigational drug or device study, or participation in such a study within 30 days of entry into this study.

  * Subject has a condition, or is in a situation which, in the investigator's opinion, may put the subject at a significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: McLean
country: United States
facility: Dr. Rajpal
state: Virginia
Study officials:
affiliation: See Clearly Vision Group
name: Rajesh Rajpal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01317030: Tear Evaluation Between Habitual Contact Lens Wearers and Non Contact Lens Wearers
Official title: Tear Evaluation Between Habitual Contact Lens Wearers and Non Contact Lens Wearers Using a Schirmer Strip for Tear Collection
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Dry Eye
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2011-03-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Specific characteristics are that one group will be habitual contact lens wearers, and the other group will be non-contact lens wearers (not having worn contact lenses within the last 7 days prior to baseline visit)

Brief summary: to evaluate tears between habitual contact lens wearers and non contact lens wearers

Detailed description: The objective of this study is to evaluate tears between habitual contact lens wearers and non contact lens wearers using a Schirmer Strip for tear collection.

Eligibility criteria: Inclusion Criteria:

* Have no allergic conjunctivitis.
* Not be using any topical ocular medications.

Exclusion Criteria:

* Considered by the Investigator to not be a suitable candidate for participation

Primary outcomes:
measure: Hyaluronan Levels
timeFrame: 7 days following lens insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb Incorporated
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Robert Steffen, OD, MS
role: STUDY_DIRECTOR
References: